Citation Vault

Background

The following document is an early draft of a 'citation vault' — a website that would allow users to embed primary-sourced facts about the current state of American infrastructure directly into blog comments, posts, articles, etc., using a simple javascript snippet.

The initial focus would be U.S. infrastructure: literacy, the school system, roads and bridges, health, the healthcare system, the environment, demographics, etc.

People reading content with embedded facts would be able to easily navigate to the primary source, and also back to each fact's page on the citation vault. There they would be able to debate the best source for any given fact, see how other people are using the same fact in different ways across the web, propose new facts, etc.

Why is this necessary?

Americans get an increasing amount their political news from Facebook comments, blog posts, newspaper articles, etc. However, even though many commenters on these sites know what they're talking about and are willing to spend tons of time writing content to try to educate others, ultimately few minds actually get changed since most of these comments aren't primary sourced. This is due to the extreme difficulty of finding the best source (and the actual truth) about any given issue.

This creates an arbitrage opportunity, where you can find people who are already doing the work to educate others online and then supply them with facts that are A) true B) important C) convincing. By providing this key tool at exactly the right place and time, it's possible to create a disproportionately large amount of political and social change.

MVP Focus:

• Facts should focus on long term structural issues in the US, rather than specific scandals or short term trends. Specifically, the focus should be on infrastructure: physical, cognitive, monetary, cultural, etc.
• Facts should either have direct implications for the long term health and stability of the US, or else provide context for other facts do.
• All facts must be absolute statistics, not comparisons with other countries.
• The focus should be on our nation's core assets themselves, not merely the systems that manage these assets. E.g. facts should focus on how healthy Americans are, not merely on the healthcare system, and how well-educated Americans are, not merely on the state of the school system, etc.
• All statistics should come from primary sources (or government reports), not news articles. Secondary sources are fine for analysis of facts, but facts themselves must come from A) Literature reviews B) government reports that cite primary sources C) the most credible meta studies in a given area D) gold standard / landmark study(s) in a given field that are highly cited. There is no a priori assumption that the reliability of different types of sources falls into a fixed hierarchy, as some types of sources can be more reliable than others in different areas. (E.g. government studies are very reliable in certain areas, but much less reliable on others.)

Current state of this document:

• This is just a quick draft to sketch out this idea — some sections are entirely unorganized. Some sections innapropriately cite secondary sources, or have editorial comments from me. The citation quality varies throughout and the overall focus is inconsistent.
• These sections were written roughly in the order in which they appear. As such many early sections are especially underdeveloped — parenting, food & nutrition, science, etc. The sections at the end are stronger — health, demographics, medical system, pharmaceuticals, k-12 education, college education, etc.
• There would ultimately be an actual user interface. Right now this document is just an enormous wall of text, but the final project would look nothing like this — if you squint a bit and use your imagination, I think you just might see something that could, with a little effort, have an enormous influence over society in years to come.

FAQ:

Aren't there a never ending number of important facts about the state of American infrastructure?
Facts likely approximately follow Zipf's Law in terms of their relative importance. That is, the most important fact about the current state of US infrastructure is likely 10x more important than the 10th most important fact, 100x as important as the 100th most important fact, etc. The vast majority of news articles about the current state of the US basically cite the same set of 1000 or so facts — or at least they would be in principle, since in practice the media gets it wrong as often as not about any given subject.

Could you use some sort of computer algorithm to aggregate these facts?
No, because even if a fact is ubiquitously cited in the media, that doesn't make it actually true. And there are countless cases where multiple major media outlet make up the same fact out of thin air. E.g. 132 million Americans don't have dental insurance, 160,000 thousand kids stay home every day from school because they are bullied, etc. Both are ubiquitously cited and heartbreaking, but also completely made up.

Have any of these ideas been tested in the real world?
Yes! I've written several comments on Hacker News and Reddit with relevant facts from this vaults embedded within them. These typically get significant upvotes and visibility. Cf. comments on Peter Thiel's graph of the year, estimated drug deaths, college tuition increases, deaths from medical errors, literacy levels, etc.

Index

• Literacy
• Parenting
• Infrastructure
• Mental Health
• Drug War
• Food & Nutrition
• Science
• Health
  • Neurodevelopmental Disorders
  • Chronic Diseases
  • Chronic Pain
  • Insomnia
• Demographics
• Criminal Justice System
• Family & Community Life
• Medical System
• Health Care Usage
• Unmet need for medical care due to cost
• Iatrogenic deaths, injury, & disability
• Quality of Care
• Insurance
• Cost of Care
• Health Literacy
• Antibiotic Resistance
• Medical Adherence
• Recommended Reading
• Pharmaceuticals
• Drug Approval Statistics
• Selective Enrollment
• Manipulation of Statistical Tests
• Efficacy Requirements
• Relapse Prevention Studies
• Statistical vs Clinical Significance
• Hiding Bad Data
• Control Over Research
• Drug Company Funding & Research Outcomes
• FDA Conflicts of Interest
• Lobbying
• Off-Label Prescriptions
• Clinical Guidelines
• Marketing To Doctors
• Medical Journals
• Phase IV Trials
• Continuing Education
• Pharmaceutical Patent Extension
• Direct-To-Consumer Advertising
• Recommended Reading
• Jobs
• Environment
• K-12 Education
  • Standardized Testing
  • Value-Added Assessment of Teachers - Empirical Evidence of Efficacy
  • Value-Added Assessment of Teachers - Statistical Problems
  • Value-Added Assessment of Teachers - Practical Problems with Implementation
  • School Choice / Vouchers
  • Tenure / Unions
  • Charter Schools
  • Merit Pay
  • Enrollment & Graduation Statistics
  • English Language Learners
  • Funding
  • Safety
  • LGBTQ
  • Special Education
  • Distance Education
  • Employment
  • Funding
  • Poverty
  • Recommended Reading
• College Education
  • College Tuition
  • Student Loan Debt
  • College Enrollment
  • Degree Attainment
  • Salary for Graduates
  • Employment
  • College Majors
  • Institutional Expenses and Revenue
  • Mal-employment of College Graduates
  • Recommended Reading
• Poverty & Financial Insecurity
• Military
• Capital
• Media

Literacy

• According to the National Adult Assessment of Literacy (NAAL), the largest and most authoritative survey of adult literacy in America, only 13% of adults are able to read English at a 'proficient' level.[1] This means that 87% of American adults lack the minimum level of literacy skill necessary to complete simple tasks like comparing the viewpoints in two editorials or computing the cost per ounce of food items. In other words, the overwhelming majority of Americans lack the minimimum amount of education required to participate in the knowledge economy or to contribute anything meaningful to the democratic process. Source: Table 1 on p. 3, Figure 2 on p. 4. from The National Assessment of Adult Literacy (NAAL) is conducted by the National Center of Education Stastics (NCES). Cf. the methodology.
• Adults unable to read prose at a 'proficient' level, by educational attainment: High school graduates - 96%, College graduates - 69%, Graduate studies/degrees - 59%. In other words, the majority of graduate students are incapable of fully understanding a newspaper, let alone an academic journal article. And virtually all high school graduates are functionally illiterate. If you think this is impossible, I'm guessing you've never graded undergraduate papers at the average college. Source: The National Assessment of Adult Literacy (NAAL) is conducted by the National Center of Education Stastics (NCES). Cf. the methodology.
• But what about the CIA World Factbook, which estimates that the United States has a 97% literacy rate as of 2002? Where do these figures come from? To quote from Jonathan Kozol's book Illiterate in America, "For one hundred years, starting in 1840, the census posed the question of the population's literacy level in its ten-year compilations. The government removed this question from its survey in the 1940 census. The reason, according to a U.S. Census Bureau publication, was a general conviction that 'most people [by this time] could read and write ...'
  
  In 1970, pressured by the military, the Bureau of the Census agreed to reinstate the literacy question. Even then, instead of posing questions about actual skills, the census simply asked adults how many years of school they had attended. More than 5 percent of those the census reached replied that they had had less than a fifth grade education. For no known reason, the government assumed that four fifths of these people probably could read and, on this dangerous assumption, it was publicly announced that 99 percent of all American adults could read and write. These are the figures which the U.S. government passed on to the United Nations for the purposes of worldwide compilations and comparisons." You can read the rest of chapter 5 here, which further explains the methodology and how the CIA figures are propaganda rather than science.
• Recommended Reading
  • Cf. John Taylor Gatto's analysis of the decline in literacy rates over the last 200 years.

Parenting

• As of 2008 only 49.8% of babies were still breastfed by age 6 months, the amount of time that both the WHO and AAP recommend exclusively breastfeeding. Further, only 25.2% of babies were still breastfed by age 1, the minimimum amount of time that the WHO recommends giving babies supplemental breastmilk. And 36.2% of babies were never breastfed at all." Sources: Newsweek, Wikipedia, Infant Feeding Practices II Study.
• Research has shown that the single best predictor of a child's vocabulary (and later academic success) is the amount that their parents talk to them as young children. To quote the findings, "The more parents talked to their children, the faster the children's vocabularies were growing and the higher children's IQ test scores at age 3 and later." This is problematic because while high-SES parents tend to address at least 2,500 words per hour to their children, the children of low-SES parents often heard less than 500. The result was that, "By the time they were 3 years old, parents in less economically favored circumstances had said fewer different words in their cumulative monthly vocabularies than had the children in the most economically advantaged families in the same period of time." What does this mean?
  
  "[By age 4], an average child in a professional family would have the accumulated experience with almost 45 million words, an average child in a working-class family would have accumulated experience with 26 million words, and an average child in a welfare family would have accumulated experience with 13 million words. [...] Just to provide an average welfare child with an amount of weekly language experience equal to that of an average working-class child would require 41 hours per week of out-of-home experience as rich in words addressed to the child as that in an average professional home." The researchers calculate that it would take thousands of hours to even put a dent in the lives of the low-SES children, and thousands more hours to get them caught up with even the children of the working class parents. Their sobering conclusion was that in reality this would be completely impossible, stating that, "By the time children are 4 years old, intervention programs come too late and can provide too little experience to make up for the past." Source: Meaningful Differences in the Everyday Experience of Young American Children, p. xx, p. xvi, 198, 201

Infrastructure

• The American Society for Civil Engineers (ASCE) regularly grades U.S. infrastructure based on capacity, condition, operations and maintenance, current and future funding, public safety, and resilience. The report examines the current state of our aviation, bridges, dams, drinking water, energy, hazardous waste, inland waterways, levees, public parks & recreation, rail, roads, school buildings, solid waste management, transit, and wastewater management. The grades for 2009? 11 D's and 4 C's. In 2009, ASCE estimated that $2.2 trillion needs to be invested over five years to bring the condition of the nation's infrastructure up to a good condition. If this money is not invested (which it hasn't been), making the repairs to our failing infrastructure will become increasingly cost prohibitive. Further, what the ASCE defines as 'good condition' does not include the money it would take to match the advances of the numerous foreign countries that have surpassed us in many categories, e.g. it does not include the additional $500 billion it would take to create a US high speed rail network competitive with Europe or China. Rather, it merely means fixing the decay in our current infrastructure and scaling it to meet future population growth. The following statistics, unless otherwise noted, come from the 2009 ASCE report.
• "[EPA] analysis estimated a potential 20-year funding gap for drinking water capital expenditures as well as operations and maintenance. The Congressional Budget Office (CBO) concluded in 2003 that 'current funding from all levels of government and current revenues generated from ratepayers will not be sufficient to meet the nation's future demand for water infrastructure.'"
• "Leaking pipes lose an estimated seven billion gallons of clean drinking water a day."
• "Every year, sewer overflows contaminate U.S. waters with 860 billion gallons of untreated sewage, an amount that could fill 1.3 million Olympic- size swimming pools or cover the entire state of Pennsylvania with one inch of sewage. This sewage contains pathogens such as bacteria, parasites, and viruses, as well as pharmaceuticals, synthetic hormones, and personal care products." Source: EPA via Green For All
• "More than 26%—more than one in four—of the nation's bridges are either structurally deficient or functionally obsolete."
• "There are currently 1,819 high hazard dams in the US. Over the past six years, for every deficient, high hazard potential dam repaired, nearly two more were declared deficient."
• "Nearly half of American households do not have access to bus or rail transit, and only 25% have what they consider to be a good alternative. The Federal Transit Administration estimates that $15.8 billion is needed annually to maintain conditions and $21.6 billion is needed to improve to good conditions. In 2008, federal capital outlays for transit were only $9.8 billion."
• "Americans spend 4.2 billion hours a year stuck in traffic at a cost to the economy of $78.2 billion, or $710 per motorist. Poor conditions cost motorists $67 billion a year in repairs and operating costs. One-third of America's major roads are in poor or mediocre condition and 45% of major urban highways are congested. Current spending of $70.3 billion per year for highway capital improvements is well below the estimated $186 billion needed annually to substantially improve conditions."
• "In 2007, 41,059 people were killed in motor vehicle crashes and 2,491,000 were injured.4 Motor vehicle crashes cost the U.S. $230 billion per year—$819 for each resident in medical costs, lost productivity, travel delays, workplace costs, insurance costs, and legal costs."
• "Aging systems discharge billions of gallons of untreated wastewater into U.S. surface waters each year. The Environmental Protection Agency estimates that the nation must invest $390 billion over the next 20 years to update or replace existing systems and build new ones to meet increasing demand."
• "Every year the industry incurs avoidable air traffic control delays that [...] waste hundreds of millions of dollars. [...] The air traffic control system remains outdated and inefficient, and modernization efforts continue to meet with delay."
• "The increasing volume of electronic waste and lack of uniform regulations for disposal creates the potential for high levels of hazardous materials and heavy metals in the nation's landfills, posing a significant threat to public safety."
• State governments reported more than $15 billion in unmet needs for maintaining public parks, for which they received a total of $28 million.
• The U.S. currently imports 60% of all the oil that it consumes, and American society is utterly dependent on this oil for everything from transportation to food production, housing, clothing. (If access to cheap oil were ever interrupted, virtually all of American society would grind to a halt.) Half of all Americans live in suburbs, despite the fact that "low-density suburban development is more energy and GHG intensive (by a factor of 2.0-2.5) than high-density urban core development on a per capita basis." Sources: Oil Politics in the United States, 2000 Census via CNN, Comparing High and Low Residential Density: Life-Cycle Analysis of Energy Use and Greenhouse Gas Emissions
• Recommended reading:
  • How the FRA is Regulating Passenger Rail Out of Existence (Cf. comments)
  • Long Barred from American Tracks, European Train Designs Could Get Rolling by 2015
  • Why building a new subway line costs over 500,000 per foot

Mental Health

• 24% of adults and 32% of parents rate their level of stress as 'extreme'. Sources: APA Stress Survey, APA Stress in America 2010 Overview
• According to the National Institute of Mental Health (NIMH), 26% of the U.S. adult population suffers from a diagnosable mental illness in any given year. Of these, 22% of cases are considered severe. In total, about 6 percent, or 1 in 17 Americans currently suffer from a seriously debilitating mental illness. The average age-of-onset is 14 years old. Source: NIMH
• "In their lifetimes, about one-half of Americans will have a serious mental health condition. Almost 30% of Americans will experience an anxiety disorder, and 17% will have a major depressive disorder. Research suggests that fewer than one-half of people with serious mental illness receive treatment." Source: CDC
• "In 1987, there were 1.25 million people receiving an SSI or SSDI payment because they were disabled by mental illness, or in every 184 Americans. [...] The Food and Drug Administration approved Prozac in 1987, and over the next two decades the number of disabled mentally ill on the SSI and SSDI rolls soared to 3.97 million. In 2007, the disability rate was 1 in every 76 Americans." Source: Anatomy of an Epidemic, p. 7
• "In 1987, there were 16,200 children under eighteen years of age who received an SSI payment because they were disabled by a serious mental illness. [...] But starting in 1990, the number of mentall ill children began to rise dramatically, and by the end of 2007, there were 561,569 such children on the SSI disability rolls. In the short span of twenty years, the number of disabled mentally ill children rose thirty-five fold. Mental illness is now the leading cause of disability in children [...]" Source: Anatomy of an Epidemic, p. 8
• "The GAO, in its June 2008 report, concluded that one in every sixteen young adults is now 'seriously mentally ill.' There has never been a society that has seen such a plague of mental illness in its newly minted adults, and those who go on the SSI and SSDI rolls at this young age are likely to spend the rest of their lives receiving disability payments. The twenty-year-old who goes on SSI or SSDI will receive more than $1 million in benefits over the next forty or so years, and that is a cost — should this epidemic countinue to grow — that our society will not be able to afford." Source: Anatomy of an Epidemic, p. 10
• Of college-age Americans (18 - 24), approximately 40% have a currently diagnosable Axis I psychiatric disorder. These conditions include depression, anxiety disorders, bipolar disorder, ADHD, autism spectrum disorders, anorexia nervosa, bulimia nervosa, and schizophrenia. Source: Mental Health of College Students and Their Non-College-Attending Peers
• "According to the 2006 National Survey of Counseling Center Directors, 91.6% of respondents believe that the number of students with severe psychological problems has increased in recent years, representing a major concern for their centers." Source: Mental Health of College Students and Their Non-College-Attending Peers
• Only 36% of those with a mental disorder are receiving treatment. And 1 in 3 of those are getting 'minimally adequate treatment.' Source: NIMH
• Robert Whitaker's book Anatomy of an Epidemic makes a compelling case much of this increase in mental illness is not because doctors are better at diagnosing it, as commonly believed, but rather because the long-term use of psychiatric drugs tends to make mental illnesses worse, rather than better. Here is a brief overview of the book, and another much longer review that was written by the former editor-in-chief of the New England Journal of Medicine. That said, to understand the entire argument you'd have to read the actual book.
• The World Health Organization (WHO) has found that those who suffer from mental illness in 'less developed' countries tend to have much better outcomes than those in America. To quote Whitaker, "At both two-year and five-year follow-ups, the patients in the poor countries were doing much better. The researchers concluded that schizophrenia patients in the poor countries 'had a considerably better course and outcome than (patients) in developed countries. This remained true whether clinical outcomes, social outcomes, or a combination of the two was considered.' Two-thirds of the patients in India and Nigeria were asymptomatic at the end of five years." The WHO then conducted a second study, "which confirmed the findings of the first: two-year outcomes were much better for the patients in the poor countries. In broad terms, 37 percent of the patients in the poor countries (India, Nigeria and Colombia) had a single psychotic episode and then fully recovered; another 26.7% of the patients in the poor countries had two or more psychotic episodes but still were in 'complete remission' at the end of the two years. In other words, 63.7% of the patients in the poor countries were doing fairly well at the end of two years. In contrast, only 36.9% of the patients in the U.S. and six other developed countries were doing fairly well at the end of two years. The researchers concluded that 'being in a developed country was a strong predictor of not attaining a complete remission.' Although the WHO researchers didn't identify a variable that would explain this difference in outcomes, they did note that in the developing countries, only 15.9% of patients were continuously maintained on neuroleptics, compared to 61% of patients in the U.S. and other developed countries." Source: Antipsychotics/Schizophrenia
• In his book Crazy Like Us, Ethan Watters presents epidemiological evidence that many mental illnesses, such as anorexia, are mostly iatrogenic—in other words, created by the medical proffesion. He writes, "People at a given moment in history in need of expressing their psychological suffering have a limited number of symptoms to chose from—a 'symptom pool,' as he calls it. When someone unconsciously latches onto a behavior in the symptom pool, he or she is doing so for a very specific reason: the person is taking troubling emotions and internal conflicts that are often indistinct or frustratingly beyond expression and distilling them into a symptom or behavior that is a culturally recognized symptom of suffering. 'Patients unconsciously endeavor to produce symptoms that will correspond to the medical diagnostics of the time.' [...] Such a dynamic makes the official public naming of a disease such as anorexia nervosa a perilous event. It is clear to Shorter that psychiatrists and physicians themselves have long been key players in validating which new disorders or behaviors appear in the symptom pool." "So although there may have been a small number of patients who presented novel behaviors without a cultural template [...], the widespread adoption of [anorexia] would follow the official 'discovery' of the symptom or disorder and the establishment of a cultural feedback loop."
• This excellent Wired exposé on the creation of the DSM V shows how the definition and diagnosis of all mental illnesses is essentially arbitrary, rather than based in science: Inside the Battle to Define Mental Illness
• "In 2008, sales of psychotropic drugs reached $40 billion annually. One in eight Americans takes a drug prescribed for a psychiatric disorder." Source: Robert Whitaker
• 11% of Americans over age 12 were taking an antidepressant between 2005 - 2008, a 400% increase from 1988 - 1994. Overall, females were 2.5 times as likely to take antidepressant medication as males. More than 60% of Americans taking antidepressant medication have taken it for 2 years or longer, and less than one-third of Americans taking an antidepressant medication had seen a mental health professional in the past year. Source: Antidepressant Use in Persons Aged 12 and Over: United States, 2005-2008

Drug War

• At least one in every four Americans die from drug use.
  
  There are about 443,000 annual deaths from smoking.[1] This is about 1 in 5.
  
  Plus another 35,700 deaths from alcohol and alcohol-related automobile accidents.[2] Plus another 3,443 from NSAIDS.[3] Plus another 27,500 from accidental overdose of prescription opioids or illicit drugs.[4] Plus another 8,400 overdoses ruled suicides or where intent was unknown. Plus another 106,000 from fatal adverse reactions to drugs given in hospitals.[5] That's roughly 26% of the 2.4 million annual U.S. deaths right there.
  
  These numbers don't count deaths from the longterm consequences of prescription drug use, e.g. someone who takes Accutane and dies of liver failure 20 years later. Nor do they count someone who gets AIDS or hepatitis from drug use, someone who develops a mental illness from stimulant abuse, alcohol-related homicide, etc. Source:
  • [1] http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/
  • [2] http://www.cdc.gov/nchs/data/nvsr/nvsr58/nvsr58_19.pdf
        http://www.nhtsa.gov/people/injury/research/alcoholhighway/2__overview.htm
  
  • [3] Assessment of Safety of aspirin and other NSAIDs
  • [4] Leonard J. Paulozzi, Richard H. Weisler, Ashwin A. Patkar. A National Epidemic of Unintentional Prescription Opioid Overdose Deaths. The Journal of Clinical Psychiatry, 2011.
  • [5] Lazarou J, Pomeranz B, Corey P. Incidence of adverse drug reactions in hospitalized patients. JAMA. 1998;279:1200-1205.
  • [6] The methodology and validity of these figures is discussed briefly on Erowid, and is discussed in depth in Volume 1. N.b. these numbers are all thought to be underestimates for several reasons, including the fact that they don't include high school dropouts, those with serious drug problems are vastly undercounted, etc. Also, cf. this NIDA publication on the validity of various drug use measurements.
• 82% of Americans admit to having used marijuana at least once by age 50, and 73% admit to using illegal drugs other than marijuana. 89% admit to having used any illicit drug. For various reasons the researchers consider these figures be underestimates.[6] Source: Monitoring the Future (Volume 2), p. 101 & 102
• Since the passage of the Anti-Drug Abuse Act in 1986, the United States prison population has risen from around 300,000 to 2.3 million, with drug convictions accounting for the majority of the increase. Source: The New Jim Crow: Mass Incarceration in the Age of Colorblindness, pp. 6, via Wikipedia.
• There were 1,552,432 drug-related arrests in 2012, including 749,825 arrests for marijuana violations. Of all drug arrests, 82.2 percent were for possession only, including 42.4 percent for marijuana possession only. Source: FBI Uniform Crime Reports
• "Nearly nine out of ten people charged with violating the law are black or Latino, although national surveys have shown that whites are the heaviest users of pot. Mr. Bloomberg himself acknowledged in 2001 that he had used it, and enjoyed it. On the Upper East Side of Manhattan where the mayor lives, an average of 20 people for every 100,000 residents were arrested on the lowest-level misdemeanor pot charge in 2007, 2008 and 2009. During those same years, the marijuana arrest rate in Brownsville, Brooklyn, was 3,109 for every 100,000 residents." Source: A Smell of Pot and Privilege in the City
• "Blacks are nearly 4 times more likely to be arrested for marijuana than other races. [...] Seven in 10 Black marijuana arrestees are charged with felonies, compared to one-fifth for other races. Blacks convicted of marijuana felonies are 3 times more likely to be sent to prison than Nonblack marijuana felons. The upshot of these accumulating discriminations is that Blacks wind up being imprisoned for marijuana at 8 times the rate of Hispanics and 18 times the rate of Whites. At older ages, the Black-Nonblack marijuana imprisonment gap soars to nearly 4,000%." Source: Center on Juvenile & Criminal Justice
• Despite the overwhelming scientific evidence of the medical benefits of marijuana, the Drug Enforcement Administration (DEA) has approved only 109 researchers to perform bona fide research with marijuana, marijuana extracts, and marijuana derivatives such as cannabidiol and cannabinol. Only fourteen researchers are approved to conduct research with smoked marijuana on human subjects. Further, the Washington Post quotes the former NIDA director on record as saying it's "not NIDA's mission to study the medicinal use of marijuana or to advocate for the establishment of facilities to support this research." Since NIDA's stated mission "is to lead the Nation in bringing the power of science to bear on drug abuse and addiction," federally supported marijuana research will logically tilt toward the potential harms, not benefits, of cannabis. Because NIDA has a legal monopoly on the supply of legally-available cannabis, they have been able to block research even on FDA-approved studies. Source: NORML, Weed Control
• 39,392 people have been killed in the Mexican drug war since December 2006. This war has been fought largely over access to smuggling routes along the U.S. border. Source: Life on the Line, Mexican Drug War
• According to addiction expert Gabor Maté, "Invariably and without exception, they all began life as abused children. It's abuse that sets up the template for addiction later on in life in the majority of the cases where there's severe injection drug use on the street level. [...] As a physician I'm dealing with the extremes of suffering. They suffer because of their life history, then they suffer because of their addiction, and finally they suffer because of the social opprobrium and prejudice against the addicts." Large-scale research confirms this— the best predictor of injection drug use is Adverse Childhood Experiences. ACEs include factors like physical abuse, emotional abuse, sexual abuse, absence of biological parents, a mentally ill family member, etc. For each adverse childhood experience, the risk of addiction increases exponentially; those with 6 or more adverse childhood experiences are 4,600% (!) more likely to use injection drugs. Because of this, putting further stress on users by locking them up, alienating them from their families, and preventing them from getting jobs is profoundly counterproductive. In fact, studies show that jail time tends to increase drug abuse. Source: Telling Addiction, Origins of Addiction, AP
• "After 40 years, the United States' war on drugs has cost $1 trillion and hundreds of thousands of lives, and for what? Drug use is rampant and violence even more brutal and widespread." During that time the U.S. has arrested 37 million non-violent drug offenders. And last year, half of all federal prisoners in the U.S. were serving sentences for drug offenses. Source: AP
• A 2008 study by Harvard economist Jeffrey A. Miron has estimated that legalizing drugs would inject $76.8 billion a year into the U.S. economy — $44.1 billion from law enforcement savings, and at least $32.7 billion in tax revenue. Source: The Budgetary Implications of Drug Prohibition, via Wikipedia

Food & Nutrition

• "In 2010, 23.4 percent of households with children reported that there were times over the past year when they did not have enough money to buy the food they needed for their family, while the rate was 14.9 percent for households without children." Nearly 15% of the US population, or 45.8 million Americans, are currently on foodstamps. This is an increase of 34% over the last two years. Source: Food Hardship in America 2010, CNN
• 66% of American children do not get their RDI of calcium on any given day. By age 17, only 13% of girls will have gotten enough calcium to build their bones up to the optimal density. In the US it has been estimated that 54% postmenopausal white women are osteopenic and 30% are osteoporotic, and by the age of 80, 27% of women are osteopenic and 70% are osteoporotic. It is estimated that around 40% of US white women and 13% of US white men aged 50 years will experience at least one clinically apparent fragility fracture in their lifetime. (Fractures cost an estimated $17 billion per year.) At age 50, a white woman has a 17% chance of sustaining a hip fracture, 15% chance of vertebral fracture and 16% chance for forearm fracture, with comparable figures of 6%, 5% and 2.5%, respectively, for fractures in white males. A 50 year old woman has a 2.8% risk of death related to hip fracture during her remaining lifetime, equivalent to her risk of death from breast cancer. Sources: Facts and statistics about osteoporosis and its impact, AAP Report, Calcium Intake Trends and Health Consequences from Childhood through Adulthood
• "Four of the top ten causes of death today are chronic diseases with well-established links to diet: coronary heart disease, diabetes, stroke, and cancer. [...] The rise to prominence of these chronic diseases is partly due to the fact that we're not dying earlier in life of infectious diseases, but only partly: Even after adjusting for age, many of the so-called diseases of civilization were far less common a century ago—and they remain rare in places where people don't eat the way we do." Source: In Defense Of Food, p. 10
• "One of the most momentous changes in the American diet since 1909 (when the USDA first began keeping track) has been the increase in the percentage of calories coming from sugars, from 13 percent to 20 percent. Add to that the percentage of calories coming from carbohydrates (roughly 40 percent, or ten servings, nine of which are refined) and Americans are consuming a diet that is at least half sugars in one form or another—calories providing virtually nothing but energy." Source: In Defense Of Food, p. 112
• "Although an estimated 80 percent of cases of type 2 diabetes could be prevented by a change of diet and exercise, it looks like the smart money is instead on the creation of a vast new diabetes industry. The mainstream media is full of advertisements for new gadgets and drugs for diabetics, and the healthcare industry is gearing up to meet the surging demand for heart bypass operations (80 percent of diabetics will suffer from heart disease), dialysis, and kidney transplantation. At the supermarket checkout you can thumb copies of a new lifestyle magazine, Diabetic Living. Diabetes is well on its way to becoming normalized in the West—recognized as a whole new demographic and so a major marketing opportunity. Apparently it is easier, or at least more profitable, to change a disease of civilization into a lifestyle than it is to change the way that civilization eats." Source: In Defense Of Food, p. 136
• "Only the power of the sugar lobby in Washington can explain the fact that the official U.S. recommendation for the maximum permissible level of free sugars in the diet is an eye-popping 25 percent of daily calories. To give you some idea just how permissive that is, the World Health Organization recommends that no more than 10 percent of daily calories come from added sugars, a benchmark that the U.S. sugar lobby has worked furiously to dismantle. In 2004 it enlisted the Bush State Department in a campaign to get the rocemmendation changed and has threatened to lobby Congress to cut WHO funding unless the organization recants." Source: In Defense Of Food, p. 25
• "Today corn contributes 554 calories a day to America's per capita food supply and soy another 257. Add wheat (768 calories) and rice (91) and you can see there isn't a whole lot of room left in the American stomach for any other food. Today these four crops account for two thirds of the calories we eat." Source: In Defense Of Food, p. 117
• "Simplification of the food chain occurs at the level of species diversity too. The astounding variety of foods on offer in today's supermarket obscures the fact that the actual number of species in the modern diet is shrinking. Thousands of plants and animal varieties have fallen out of commerce in the last century as industrial agriculture has focused its attentions on a small handful of high-yielding (and usually patented) varieties, with qualities that suited them to things like mechanical harvesting and processing." Source: In Defense Of Food, p. 116
• "When you consider that humankind has historically consumed some eighty thousand edible species, and that three thousand of these have been in widespread use, this represents a radical simplification of the human diet. Why should this concern us? Because humans are omnivores, requiring somewhere between fifty and a hundred different chemical compounds and elements in order to be healthy. It's hard to believe we're getting everything we need from a diet consisting largely of processed corn, soybeans, rice, and wheat." Source: In Defense Of Food, p. 118
• Our monocultures of food crops and livestock leave us extremely vulnerable to blights. The ug99 wheat rust that is currently spreading in the middle east is so virulent that it kills up 100% of the wheat it comes in contact with. Because in North America the wheat rises first in Mexico, and then sequentially north all the way to Canada, a single teaspoon of ug99 delivered to the right field in northern Mexico in early spring could wipe out an enormous percentage of our wheat crop. Our potatoes and most of our other crops are similarly vulnerable, because there is virtually none of the biodiversity needed to resist disease epidemics.
Source: A 'time bomb' for world wheat crop
• "Since the widespread adoption of chemical fertilizers in the 1950s, the nutritional quality of produce in America has declined substantially, according to figures gathered by the USDA, which has tracked the nutrient content of various crops since then. Some researchers blame this decline on the condition of the soil; others cite the tendency of modern plant breeding, which has consistently selected for industrial characteristics such as yield rather than nutritional quality." In Defense Of Food, p. 115
• "USDA figures show a decline in the nutrient content of the forty-three crops it has tracked since the 1950s. In one recent analysis, vitamin C declined by 20 percent, iron by 15 percent, riboflavin by 38 percent, calcium by 16 percent. Government figures from England tell a similar story: declines since the fifties of 10 percent or more in levels of iron, zinc, calcium, and selenium across a range of food crops. To put this in more concrete terms, you now have to eat three apples to get the same amount of iron as you would have gotten from a single 1940 apple, and you'd have to eat several more slices of bread to get your recommended daily allowance of zince than you would have a century ago." Source: In Defense Of Food, p. 118
• "At least 30 percent of Americans have a diet deficient in vitamin C, vitamin E, vitamin A, and magnesium." Source: In Defense Of Food, p. 119
• "Nutritional inflation seems to have two principle causes: changes in the way we grow food and changes in the kinds of food we grow. Halweil cites a considerable body of research demonstrating that plants grown with industrial fertilizers are often nutritionally inferier to the same varieties grown in organic soils. Why this should be so is uncertain, but there are a couple of hypotheses. Crops grown with chemical fertilizers grow more quickly, giving them less time and opportunity to accumulate nutrients other than the big three (nutrients in which industrial soils are apt to be deficient anyway). Also, easy access to the major nutrients means that industrial crops develop smaller and shallower root systems than organically grown plants; deeply rooted plants have access to more soil minerals. Biological activity in the soil almost certainly plays a role as well; the slow decomposition of organic matter releases a wide range of plant nutrients, possibly including compounds science hasn't yet identified as important. Also, a biologically active soil will have more mycorrhizae, the soil fungi that live in symbiosis with plant roots, supplying the plants with minerals in exchange for a ration of sugar." Source: In Defense Of Food, p. 120
• "In addition to these higher levels of minerals, organically grown crops have also been found to contain more phytochemicals—the various secondary componuds (including carotenoids and polyphenols) that plants produce in order to defend themselves from pests and diseases, many of which turn out to have important antioxidant, antiinflammatory, and other beneficial effects in humans. Because plants living on organic farms aren't sprayed with synthetic pesticides, they're forced to defend themselves, with the result that they tend to produce between 10 percent and 50 percent more of these valuable secondary compounds than conventionally grown plants. [...] Clearly the achievements of industrial agriculture have come at a cost: It can produce a great many more calories per acre, but each of those calories may supply less nutrition than it formerly did. And what has happened on the farm has happened in the food system as a whole as industry has pursued the same general strategy of promoting quantity at the expense of quality. You don't need to spend much time in an American supermarket to figure out that this is a food system organized around the objective of selling large quantities of calories as cheaply as possible." Source: In Defense Of Food, p. 121
• "A diet based on quantity rather than quality has ushered a new creature onto the world stage: the human being who manages to be both overfed and undernourished, two characteristics seldom found in the same body in the long natural history of our species. In most traditional diets, when calories are adequate, nutrient intake will usually be adequate as well. Indead, many traditional diets are nutrient rich and, at least compared to ours, calorie poor. The Western diet has turned that relationship upside down. At a health clinic in Oakland, California, doctors report seeing overweight children suffering from old-time deficiency diseases such as rickets, long thought to have been consigned to history's dustheap in the developed world. But when children subsist on fast food rather than fresh fruits and vegetables and drink more soda than milk, the old deficiency diseases return—now even in the obese." Source: In Defense Of Food, p. 123
• "It's no accident that the small handful of plants we've come to rely on are grains (soy is a legume); these crops are exceptionally efficient at transforming sunlight, fertilizer, air, and water into macronutrients—carbohydrates, fats, and proteins. These macronutrients in turn can be profitably converted into meat, daily, and processed foods of every description. Also, the fact that they come in the form of durable seeds which can be stored for long periods of time means they can function as commodities as well as foods, making these crops particularly well adapted to the needs of industrial capitalism. The needs of the human eater are a very different matter, however. An oversupply of macronutrients, such as we now face, itself represents a serious threat to our health, as soaring rates of obesity and diabetes indicate. But, as the research of Bruce Ames and other suggests, the undersupply of micronutrients may constitute a threat just as grave. Put in the most basic terms, we're eating a lot more seeds and a lot fewer leaves (as do the animals we depend on), a tectonic dietary shift the full implications of which we are just now beginning to recognize. To borrow, again, the nutritionist's reductive vocabulary: Leaves provide a host of critical nutrients a body can't get from a diet of refined seeds. There are antioxidants and phytochemicals; there is the fiber; and then there are the essential omega-3 fatty acids found in leaves, which some researchers believe will turn out to be the most crucial missing nutrient of all." Source: In Defense Of Food, p. 125
• "Without even realizing what we were doing, we dramatically altered the ratios of [omega-3 and omega-6] in our bodies, with the resurt that the ration of omega-6 to omega-3 in the typical American today stands at more than 10 to 1. Before the widespread introduction of seed oils at the turn of the last century, the ratio was closer to 3 to 1. [...] The price role of these lipids in human health is still not completely understood, but some researchers are convinced that these historically low levels of omega-3 (or, conversely, historically high levels of omega-6) bear responsibility for many of the chronic diseases associated with the Western diet, including heart disease and diabetes." Source: In Defense Of Food, p. 127
• "Omega-6s exist in a kind of zero-sum relationship with omega-3s, conteracting most of the positive effects of omega-3 throughout the body. Merely adding omega-3s to the diet—by taking supplements, say—many not do much good unless we also reduce the high levels of omega-6s that have entered the Western diet from the advent of processed foods, seed oils, and foods from animals raised on grain. Nince percent of the calories in the American diet today come from a single omega-6 fatty acid: linoleic acid, most of it from soybean oil. Some nutrition experts think that this is fine: Omega-6s, after all, are essential fatty acids too, and their rise to dietary prominence has pushed out saturated fats, usually thought to be a positive development. But others strongly disagree, contending that the unprecedented proportion of omega-6s in the Western diet is contributing to the full range of disorders involving inflammation." Source: In Defense Of Food, p. 131
• "Since 1980, the price of sweeteners and added fats (most of them derived, respectively, from subsidized corn and subsidized soybeans) dropped 20 percent, while the price of fresh fruits and vegetables increased by 40 percent. It is the cheaper and less healthful of these two kinds of calories on which Americans have been gorging." Source: In Defense Of Food, p. 186
• Only 20 percent of American children and 32 percent of adults eat the recommended five daily servings of fruits and vegetables. Source: In Defense Of Food, p. 123
• "Is it just a coincidence that as the portion of our income spent on food has declined, spending onh ealth care has soared? In 1960 Americans spent 17.5 percent of their income on food and 5.2 percent of national income on health care. Since then, these numbers have flipped: Spending on food has fallen 9.9 percent, while spending onh ealth care has climbed to 16 percent of national income. I have to think that by spending a little more on healthier food we could reduce the maount we have to spend on health care." Source: In Defense Of Food, p. 188
• Required reading/viewing: Food, Inc., King Corn, Can we eat to starve cancer?, The Worst Mistake in the History of the Human Race, Arsenic in Our Chicken?

Science
Required Reading:

• Lies, Damned Lies, and Medical Science
• The Truth Wears Off
  • YC thread on Jonah Lehrer
  • Wrong: Why experts* keep failing us--and how to know when not to trust them
  • The Heart of Research is Sick
  • Defending Jonah Lehrer
• Grant System Leads Cancer Researchers to Play It Safe
• Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why.
• The Cult of Pharmacology: How America Became the World's Most Troubled Drug Culture
• The Mouse Trap: The dangers of using one lab animal to study every disease
• Mice Fall Short as Test Subjects for Humans' Deadly Ills
• I'd heard it was the most effective stop-smoking drug yet. So I took it. Then those reports of suicidal ideation began washing in.
• Why does anyone think science is a good job?
• Why Most Published Research Findings Are False
• Mistakes in Scientific Studies Surge
• Trials and Errors: Why Science Is Failing Us
• In cancer science, many "discoveries" don't hold up
• Lullaby for a Mouse: Anthropological Observations of an Animal Model of Psychosis
• Shift Happens

Statistics

• "In 2008, gross expenditure on R&D (GERD) increased to 2.8% and GERD per capita was USD 1,307. [...] Two-thirds of GERD was financed by industry and 27% by government. In the same year, business enterprises performed 73% of GERD, the higher education sector 13% and the government sector 11%." Source: OECD Science and Innovation Report
• "Science and engineering degrees are 15% of all new degrees." Source: OECD Science and Innovation Report
• "When asked to name a scientist, Americans are stumped. In one recent survey, the top choice, at 47 percent, was Einstein, who has been dead since 1955, and the next, at 23 percent, was 'I don't know.' In another survey, only 4 percent of respondents could name a living scientist. While these may not have been statistically rigorous exercises, they do point to something real: In American public life, researchers are largely absent." Source: NYTimes

Health

• Just 1.2% of Americans meet all 7 cardiovascular health metrics from 2005 to 2010, compared to 2% from 1988 to 1994. These metrics are not smoking, being physically active, having blood pressure under control, maintaining healthy blood glucose levels, maintaining healthy blood cholesterol levels, mainting a healthy body weight, and following a healthy and balanced diet.
Source: JAMA, via Medical News today
• Compared to those born between 1900 and 1931, Americans born between 1962 and 1978 were 3 times more likely to have grown up in severely abusive homes, 5 time more likely to have attempted suicide, 4.5 times more like to have contracted a sexually transmitted disease, 50% more likely to have suffered depression, and 50% more likely to have experienced alcohol addiction. Source: The impact of adverse childhood experiences on health problems: evidence from four birth cohorts dating back to 1900
• The prevalence of obesity among school-age children and adolescents almost doubled between 1988-1994 and 2007-2008, increasing from 11% to 20% among children 6-11 years of age, and increasing from 11% to 18% among adolescents 12-19 years of age. Among children ages 2-5, the rate of obesity increased from 7% to 10%. Source: CDC
• In a self-reported survey from 2007, 35.5% of U.S. adults were classified as physically inactive in 2007, meaning they received less than 150 minutes of moderate-intensity activity per week, or 75 minutes of vigorous-intensity activity per week, or an equivalent combination of moderate- and vigorous-intensity physical activity. This is considered to be the minimum recommended aerobic physical activity required to produce substantial health benefits in adults. According to the CDC, only 18.8% report doing either aerobic activity or muscle strengthening activity in their leisure time. Source: CDC_1, CDC_2
• In 2008, the Department of Health and Human Services released updated guidelines for aerobic activity and muscle-strengthening activities for Americans. In 2010, 32% of men and 20% of women age 18 - 144 met both sets of guidelines. These same guidelines were met by 16.6% of men and 11.0% of women age 65-74, and by only 9% of men and 4% of women age 75+. Source: CDC
• In 2010, 50% of adults 18 years of age and over met neither the aerobic activity nor the muscle strengthening physical activity federal guidelines. This percentage increased with age, rising from 39% of adults 18-24 years of age to 70% of adults 75 years and over. Source: CDC
• Between 1997-1999 and 2007-2009, the percentage of children with respondent-reported food allergies increased from 3% to 5%, and the percentage with skin allergies increased from 7% to 11%. Source: CDC
• 9.6% of US children currently have asthma. This is compared with approximately 3.6% in 1980. (N.b. The methodology has changed somewhat, so the rate has perhaps closer to doubled.) Source: CDC_1, CDC_2
• Between 2005-2008, 50.9% of Americans had used dietary supplements within the past 30 days. These are completed unregulated, and as such are not tested for potency, purity, or safety. Source: CDC
• The percentage of the population taking at least one prescription drug during the previous month increased from 38% in 1988-1994 to 48% in 2005-2008. During the same period, the percentage taking three or more prescription drugs increased from 11% to 21%. Source: CDC
• Despite the dramatic declines in blood lead levels of Americans over the past 40 years, "approximately 250,000 U.S. children aged 1-5 years have blood lead levels greater than 10 micrograms of lead per deciliter of blood, the level at which CDC recommends public health actions be initiated. Lead poisoning can affect nearly every system in the body. Because lead poisoning often occurs with no obvious symptoms, it frequently goes unrecognized." Source: CDC
• 10.2% of mothers smoked cigarettes during pregnancy in 2008. Source: CDC
• "There are about 50,000 chemicals used in consumer products in the U.S. The EPA has tested 300 of them for dangerous effect. 5 are banned. Source: Scientific American
• The CDC currently maintains data on 219 industrial chemicals measured in people's blood or urine. For most of these chemicals it is completely unknown what the levels are safe. Source: CDC
• "Between 1993 and 2007, the rate of preterm birth rose from 11.0% of births in 1993 to 12.7% of births in 2007. This increase was statistically significant. [...] Long-term motor, cognitive, visual, hearing, behavioral, social-emotional, health, and growth problems may not become apparent for years, and may persist throughout a child's life. The birth of a preterm or low birth weight infant can have significant emotional and economic effects on the infant's family." (The rate of term low birth weight stayed relatively constant between 2.5% and 2.7% during the same period.)
Source: The EPA publication America's Children and the Environment, Third Edition, DRAFT

Neurodevelopmental disorders

• 13.1% of all school children now receive special services for a neurodevelopmental disability, up from 8.3% in 1976. Source: NCES
• For children ages 11 - 17, 14.1% of boys and 5.4% of girls have now been diagnosed with ADHD. "Recent epidemiological studies (most published since 2006) have linked increased levels of lead in hair and blood, mercury in blood, phthalate metabolites in urine, and the pesticide chlorpyrifos in cord blood (indicative of prenatal exposure) with increased likelihood of ADHD." Source: America's Children and the Environment, Third Edition, DRAFT
• 12.3% of boys and 7.1% of girls have been diagnosed with a learning disability. And between 1997 and 2008, the rate of autism in 5 - 17 year olds rose from .1% to .7%. Source: America's Children and the Environment, Third Edition, DRAFT
• "Most neurodevelopmental disorders have complex and multiple contributors rather than any one 26 clear cause. These disorders likely result from a combination of genetic, biological, psychosocial 27 and environmental risk factors, as well as behavioral risk factors such as alcohol, tobacco, or 28 illicit drug use." Source: America's Children and the Environment, Third Edition, DRAFT
• "Studies have found that several widespread environmental contaminants can damage a child's developing brain and nervous system." These common contaminants include, but are not limited to, lead, mercury, PCBs, PBDEs, phthalates, dioxins and furans, perchlorate, heavy metals such as cadmium, arsenic, and manganese, and pesticides like organophosphate, organochlorine, and chlorpyrifos. "This disruption can lead to neurodevelopmental deficits that may have an effect on the child's achievements and behavior even when they do not result in a diagnosable disorder." Source: America's Children and the Environment, Third Edition, DRAFT
• "Childhood exposure to lead may contribute to learning problems, such as reduced cognitive development, that define or are common in developmental disorders. Studies have also found associations between childhood exposure to lead and ADHD, hyperactivity and distractibility; increased likelihood of dropping out of high school, reading disability, lower vocabulary, and lower class standing in high school; and increased risk for antisocial, delinquent, or criminal behavior. Lead exposure has also been found to cause deficits in memory and planning and cause impulsiveness in children." Source: America's Children and the Environment, Third Edition, DRAFT

Chronic Diseases

• "In 2009, 145 million people—almost half of all Americans—live with a chronic condition. [...] The percentage of health care spending that is associated with people with chronic conditions has increased from 78 percent to 84 percent in just seven years." Source: Robert Wood Johnson Foundation
• "The proportion of all Americans with two or more chronic conditions has increased from 24 percent in 2001 to 28 percent in 2006. The percentage of persons with five or more chronic conditions has also increased; now as many as 6 percent of all females and 4 percent of males have five or more chronic conditions. [...] The average annual out-of-pocket spending has increased by nearly 30 percent since 2001 for those with one or more chronic conditions."Source: Robert Wood Johnson Foundation
• 90.7% of Americans over age 65 have at least one chronic condition, and 73.1% have multiple chronic conditions. Source: Robert Wood Johnson Foundation
• "Health care spending for a person with one chronic condition is almost three times greater than spending for someone without any chronic condition, while spending is about 17 times greater for someone with five or more chronic conditions." Source: Robert Wood Johnson Foundation
• "Sixteen percent of spending is for the 50 percent of the population that has no chronic conditions. [...] Twenty-one percent of spending is for the 5 percent of the population that has five or more chronic conditions."
• 7 out of 10 deaths among Americans each year are from chronic diseases. Heart disease, cancer and stroke account for more than 50% of all deaths each year. Source: CDC
• "The prevalence of obesity among school-age children and adolescents increased from 11% to 18% between 1988-1994 and 2009-2010." "Excess body weight in children is associated with excess morbidity in childhood and adulthood." Source: CDC
• "The proportion of men who are obese grew from 10.7% in 1960-1962 to 34.4% in 2007-2010 although there was no increase after 2005-2006. For women, this proportion increased from 15.7% to 36.1% during the same time period. The percentage of men and women at a healthy BMI has decreased from 51.2% in 1960-1962 to 29.8% in 2007-2010." Source: CDC
• "The prevalence of hypertension (defined as high blood pressure or taking antihypertensive medication) increases with age. In 2005-2008, 9.1% of men and 3.2% of women 20-34 years of age had hypertension, as compared with 33.3% of men and women age 45-54, and 67% of men and 80% of women age 75 and over." Source: CDC
• "In 2005-2008, 11% of adults 20 years of age and over had diabetes (diagnosed and undiagnosed). In 2005-2008, the percentage of adults with diabetes increased with age from 4% of persons 20-44 years of age to 14% of adults age 45 - 64 and 27% of adults 65 years of age and over." Source: CDC
• "In 2009, 46% of men and 31% of women 75 years of age and over had ever been told by a physician or other health professional that they had heart disease." "Heart disease is the leading cause of death in the United States. In 2007, one-quarter of all deaths (616,000) were from diseases of the heart. The majority (81%) of heart disease deaths were among people 65 years of age and over." Source: CDC
• In 2009, 23% of men and 17% of women 75 years of age and over had ever been told by a physician or other health professional that they had cancer (excluding the common types of skin cancers). Cancer is the second leading cause of death in the United States after heart disease. In 2007, there were 560,000 deaths from all sites of cancer combined, accounting for 23% of all deaths. Seven in ten (69%) cancer deaths were to persons 65 years of age and over. Cancer is the leading cause of death for persons ages 45-64 and the second leading cause of death for 25-44 year olds. Source: CDC
• In 2010, 27.1% of adults age 18-64 and 61.7% of adults age 65+ had at least one basic actions difficulty or complex activity limitation. That means in total, 32.8% of adults age 18+ have at least one disability. Basic actions difficulty captures limitations or difficulties in movement, emotional, sensory, or cognitive functioning associated with a health problem. Complex activity limitation is a construct used to measure disability as defined by the inability to function successfully in certain social roles. Complex activities consist of the tasks and organized activity that make up numerous social roles like working, maintaining a household, living independently, or participating in community activities. Source: CDC
, Table 54.
• "In 2009, the percentage of noninstitutionalized adults who reported their health as fair or poor ranged from 6% of those 18-44 years of age to 29% of those 75 years and over. The proportion of all persons with fair or poor health was five times as high among persons living in poverty as among those with family income at least four times the poverty level." Source: CDC

Chronic Pain

• "Common chronic pain conditions affect at least 116 million U.S. adults at a cost of $560-635 billion annually in direct medical treatment costs and lost productivity. [...] [It] is much more than a biological phenomenon and has profound emotional and cognitive effects. [It] contributes greatly to national rates of morbidity, mortality, and disability; and is rising in prevalence." Source: Institute of Medicine
• "Because pain often produces psychological and cognitive effects—anxiety, depression, and anger among them—interdisciplinary, biopsychosocial approaches are the most promising for treating patients with persistent pain. But for most patients (and clinicians), such care is a difficult-to-attain ideal, impeded by numerous structural barriers—institutional, educational, organizational, and reimbursement-related. [...] In addition, adequate pain treatment and follow-up may be thwarted by a mix of uncertain diagnosis and societal stigma consciously or unconsciously applied to people reporting pain, particularly when they do not respond readily to treatment. [...] Understanding chronic pain as a disease means that it requires direct treatment, rather than being sidelined while clinicians attempt to identify some underlying condition that may have caused it." Source: Institute of Medicine
• "Between 2002 and 2009, about 30% of adults 18 years of age and over reported recent (in the past 30 days) symptoms of pain, aching, or swelling around a joint. The knee was the most common painful joint reported (Table 53). During this period, the percentage of adults of all ages who reported recent joint pain was unchanged. Reported joint pain was strongly associated with age. In 2009, one in five adults 18-44 years, 42% of adults 45-64 years, and about one-half of adults 65-74 years and 75 years of age and over had recent joint pain." Source: CDC
• "Back pain is an epidemic. The numbers are sobering: There's an 80 percent chance that, at some point in your life, you'll suffer from it. At any given time, about 10 percent of Americans are completely incapacitated by their lumbar regions, which is why back pain is the second most frequent reason people seek medical care, after general checkups. And all this treatment is expensive: According to a recent study in The Journal of the American Medical Association, Americans spend nearly $90 billion every year treating back pain, which is roughly equivalent to what we spend on cancer." Source: Wired

Insomnia

• "An estimated one-third of all US adults experience weekly difficulties with nighttime sleep and an estimated 50-70 million people complain of nighttime sleep loss associated with daytime impairment. [...] The vast majority of people with insomnia also carry at least one diagnosis of a comorbid disorder." Source: PubMed
• Based on an analysis of 74,571 adult respondents in 12 states, [...] "37.9% reported unintentionally falling asleep during the day at least once in the preceding month, and 4.7% reported nodding off or falling asleep while driving at least once in the preceding month." Source: CDC
• "The estimated prevalence of insomnia in [...] working people was 23.2%. [...] The population-level projections [...] amount to annual losses in work performance associated with insomnia equal to [...] 252.7 million days and $63.2 billion after controlling for comorbidity." Source: NIH

Good News

• Between 1971 - 1974 48% of Americans had untreated cavities. That is down to 23.2% between 2005 - 2008. Source: CDC
• From 1980 through 2007, life expectancy at birth in the United States increased from 70 years to 75 years for men and from 77 years to 80 years for women. Source: CDC
• Between 1965 and 2012, the percentage of Americans over 18 years of age who currently smoke has declined from 41.9% to 19.3%. Source: CDC
• Between 1991 and 2009, the percentage of high school students who reported rarely or never using a seat belt declined from 26% to 10%. Source: CDC

Conclusion

• The manifesto Being Healthy Is A Revolution Act perhaps sums it up best when they say: "The United States currently produces more obese, chronically ill and depleted people than it does vital, fit, resilient ones — and this trend is worsening. Two out of three U.S. adults is overweight or obese. At any given time, half of us are contending with at least one chronic disease. a growing number of us are reliant on pharmaceuticals whose side effects and interactions undermine our health and quality of life. The way we are living is crazy. Our children, too, are becoming ill and prescription dependent at ever younger ages, and their life spans are being shortened as a result."
• Required reading: The Unknown Epidemic: Type I Diabetes, Autoimmune Diseases, On The Rise

Demographics

• As of 2010, 12.97% of Americans were age 65+. This is expected to increase to 19.30% by 2030 and 20.17% by 2050. Source: Census.gov
• While 74% of first births to white women occurred within marriage, 54% of first births to Hispanic women and 23% of first births to black women occurred within marriage. Source: CDC
• 47% of college graduates 22-44 years of age were childless at the date of interview compared with 9% childless among women 22-44 years of age with less than a high school education. Source: CDC
• The proportion of women with three or more children is also closely associated with lower levels of education and income—for example, only 12 percent of college-educated women have had three or more children compared with 47 percent of women with less than a high school education. Source: CDC
Roughly 35% of recent births were unintended at time of conception, 14% were unwanted, and 21% were mistimed. The 14 percent of recent births that were unwanted represents an increase from the 9 percent seen for recent births in 1995. 12% of recent births were reported to have occurred 2 or more years too soon (as opposed to less seriously mistimed). Source: CDC
• Life expectancy from birth is expected to increase from 78.3 years in 2010 to 80.7 years in 2030 and 83.1 years in 2050. Census.gov
• Hispanics make up 16.03% of the US population as of 2010. They are projected to make up 23.01% by 2030 and 30.25% by 2050. The population of non-hispanic whites is 64.74% as of 2010, and is projected to decrease to 55.48% by 2030 and 46.32% by 2050. Asians are 4.65% of the population as of 2010, and are projected to make up 6.31% by 2030 and 7.84% by 2050. All other races will remain roughly stable by percentage. Source: Census.gov
• The total population is projected to increase from 310 million in 2010 to 373 million in 2030 and 439 million in 2050. Source: Census.gov
• Total births expected by education, for women age 15 - 44:
  • No high school diploma or GED: 2.94
  • High school diploma or GED: 2.30
  • Some college, no bachelor's degree: 2.20
  • Bachelor's degree or higher: 2.08
  • Source: CDC
• Total births expected by percent of poverty level, for women age 15 - 44:
  • 0 - 149 percent: 2.74
  • 150 - 299 percent: 2.36
  • 300 percent or higher: 1.95
  • Source: CDC
• In 2010, 13.0% of Americans were age 65+. This is projected to increase to 19.3% by 2030, and 20.0% of Americans by 2040. Census.gov
• Required Reading: http://www.npr.org/2011/10/14/141362862/u-s-birthrate-dropped-during-recession

Criminal Justice System

• A recent study found that adjudicated juvenile delinquents were four times more likely to have highly elevated bone lead concentrations than controls, and concluded that elevated body lead burdens are associated with elevated risk for adjudicated delinquency. Source: Bone lead levels in adjudicated delinquents: A case control study
• "Blacks are much more likely than white or Hispanic defendants to receive heightened mandatory minimum penalties, and the difference in the likelihood increases as the penalty increases. [...] In 1998 black defendants comprised only 30 percent of cases subject to a five year mandatory minimum. However, they comprise over 40 percent of cases subject to a ten year mandatory minimum, over 60 percent of cases subject to a 20 year mandatory minimum, and almost 80 percent of cases subject to a mandatory life term." Source: Statement of John R. Steer, Member and Vice Chair of the United States Sentencing Commission
• Private prisons get to extend the sentences of inmates if they test positive for drugs while in prison. Guess whether it's public or private prisons where inmates are roughly 8 times more likely to test positive for drug use? To cite a recent report on the difference between private prisons and those run by the Federal Bureau of Prisons: "In private prisons, 34 percent of the respondents indicated that the respective prison had hit rates for banned substances of 0 percent. About 40 percent of private prisons had positive hit rates of 3 percent or above, and almost 20 percent of the private prisons had rates at or above 10 percent."
  
  "If attention is restricted to BOP secure institutions with a security rating of low and medium (the BOP security levels most comparable to the majority of private prisons), [...] sixty-six percent of the 57 BOP low- and medium-security institutions had a positive detection rate of 0 percent. A positive rate of 1 percent was observed in 7 percent of the institutions. A rate of 2 percent was observed in 14 percent of the institutions. And a rate of 3 percent or greater was observed in 12 percent of the prisons. A positive rate of 6 percent was the largest rate observed for low- and medium-security BOP prisons during this month." Source: Growth and Quality of U.S. Private Prisons: Evidence from a National Survey
• 2,284,900 adults are currently incarcerated: 760,400 are in jail, and 1,524,513 are in prison. This is approximately 1% of American adults. Source: Correctional Populations in the United States, 2009, Resident Population by Sex and Age
• 5,018,900 adults are currently under 'community supervision': 4,203,967 are on probation, and 819,308 are on parole. In total, 7,225,800 American adults are currently incarcerated or under supervision by the correctional system. This is approximately 3.1% of adults. Source: Correctional Populations in the United States, 2009, Resident Population by Sex and Age
• "In addition, more than 80,000 youth are held in juvenile detention facilities on any given day. Before being deported, about 400,000 people a year also pass through our immigration detention system, which is run mostly by the Department of Homeland Security. Hundreds of thousands more are held in halfway houses and police lockups; no one knows the exact number. The Bureau of Indian Affairs oversees jails in Indian Country, and the Department of Defense has its own network of more than sixty detention facilities all over the globe." Source: Prison Rape: Obama's Program to Stop It
• "In 2009, the majority (82%) of the total correctional population was male, and 18% was female. Men comprised a smaller portion of the total correctional population in 2009 than in 1990 (86%)." Source: Correctional Populations in the United States, 2009
• 92.1% of federal prisoners and 47.6% of state prisoners are serving time for non-violent crimes. Source: Bureau of Justice Statistics Bulletin: Prisoners in 2009
• From 2000 to 2008, the state prison population increased by 159,200 prisoners, and violent offenders accounted for 60% of this increase. Source: Bureau of Justice Statistics Bulletin: Prisoners in 2009
• An estimated 34% of California inmates and 25 - 40 percent of all inmates are infected with hepatitis C, as compared with 1.8% of the general public. The latest Hepatitis C treatments cost as much as $30,000 per inmate annually. Limited studies indicate that fewer than 10 percent of prisoners who have contracted hepatitis C are treated. There is no widespread screening of new inmates even though it only costs $5 - $10. Prisoners often have to wait up to five years just to get tested.
  
  "With more than 90 percent of incarcerated persons returning to their communities, it is clear that when a prisoner is infected, we are all affected. [...] More than $1 billion is already spent each year on this country on hepatitis C, and those costs are expected to soar unless prevention and treatment are expanded. Without those changes, researchers project that liver-related deaths will triple from around 13,000 in 2000 to 39,000 by 2030. It's also estimated that 375,000 Americans with hepatitis C will develop cirrhosis by the year 2015." Source: Hepatitis C Virus Infection among Prisoners in the California State Correctional System, One in 100: Behind Bars in America 2008, Prison's deadliest inmate, hepatitis C, escaping
• Corrections expenditures were 3.4% of total state expenditures in 2009. Source: National Association of State Budget Officers, 2009 State Expenditure Report
• Only 2% of prisoners are able to read at a 'proficient' level, as measured by the National Adult Literacy Survey and described above. Source: Literacy Behind Bars, p. 13
• 64 percent of local jail inmates, 56 percent of state prisoners and 45 percent of federal prisoners have symptoms of serious mental illnesses. 43% of State prisoners and 54% of jail inmates reported symptoms that met the criteria for mania. About 23% of State prisoners and 30% of jail inmates reported symptoms of major depression. An estimated 15% of State prisoners and 24% of jail inmates reported symptoms that met the criteria for a psychotic disorder. Source: Mental Health Problems of Prison and Jail Inmates
• Only 34% of state prisoners with mental health problems received any treatment since admission, followed by Federal prisoners (24%) and local jail inmates (17%). Source: Mental Health Problems of Prison and Jail Inmates
• Among nearly 300,000 prisoners released in 15 States in 1994, 67.5% were rearrested within 3 years. 51.8% were back in prison, serving time for a new prison sentence or for a technical violation of their release, like failing a drug test, missing an appointment with their parole officer, or being arrested for a new crime. Source: Bureau of Justice Statistics Special Report: Recidivism of Prisoners Released in 1994
• "The text of the Prison Rape Reduction Act of 2002 states that the best expert estimate of the percentage of individuals who are sexually attacked at least 1 time during their incarceration is a national median of 13.6%." Source: HIV Transmission and Prevention in Prisons
• Required reading:
  • America's Real Criminal Element: Lead. See also: Environmental Policy as Social Policy? The Impact of Childhood Lead Exposure on Crime
  • Did Steven Levitt, author of "Freakonomics", get his most notorious paper wrong?

Required Reading

• The United States holds tens of thousands of inmates in long-term solitary confinement. Is this torture?
• Controversial Drug Given to All Guantanamo Detainees Akin to "Pharmacologic Waterboarding"
• Has the Most Common Marijuana Test Resulted in Tens of Thousands of Wrongful Convictions?
• Prison Labor: Outsourcing's "Best Kept Secret"
• Nightmare at the Day Care: The Wee Care Case
• Trial by Fire: Did Texas execute an innocent man?
• We fabricated drug charges against innocent people to meet arrest quotas, former detective testifies
• The Prosecution's Case Against DNA
• Error Rates in Forensic Science
• By age 23, almost a third of Americans have been arrested for a crime. Original study here: Cumulative Prevalence of Arrest From Ages 8 to 23 in a National Sample
• Incarceration Nation
• Uncompromising Photos Expose Juvenile Detention in America
• Can Unconscious Bias Undermine Fingerprint Analysis?
• US prison inmates returning to society: How will they be received?
• Raise the Crime Rate
• 40 Years And $4 Billion After Furman: California's Cruel and Unusual Death Penalty
• The Mind of a Police Dog: How misconceptions about dogs can lead to abuse of humans
• False Alerts: Growing Evidence that Drug-Sniffing Dogs Reflect Police Bias

Family & Community Life

Medical System

Health Care Usage

• "The percentage of the population with at least one prescription drug during the previous month increased from 38% in 1988-1994 to 48% in 2005-2008. During the same period, the percentage taking three or more prescription drugs increased from 11% to 21%." Source: CDC
• "In 2008, there were about 1.2 billion visits to physician offices, hospital outpatient departments, and hospital emergency departments. There were 956 million visits to physician offices, 110 million visits to hospital outpatient departments, and 124 million visits to hospital emergency departments." Source: CDC
• "In 2009, 21% of adults 18 years of age and over had at least one emergency department visit in the past year, and 8% had two or more visits. Emergency department utilization was 93% higher among persons with a family income below the poverty level compared with those with a family income at least four times the poverty level." Source: CDC
• "Between 1997 and 2009, two-thirds of persons 2 years of age and over had seen a dentist in the past year. Dental visit rates were higher among children 2-17 years of age than among adults, with about three-quarters of children having had a recent dental visit during this period." Source: CDC
• "Only half of adults received all age-appropriate preventive services in 2008, such as immunizations, cancer screenings, and blood pressure and cholesterol tests, with little change since 2002. There continue to be wide income- and insurance-based disparities in receipt of preventive care. Improvement in these areas will require expanding insurance coverage, strengthening people's connections to primary care, and implementing practice interventions to make the delivery of preventive services a routine part of patient care." Source: Commonwealth Fund National Scorecard on U.S. Health System Performance, 2011

Unmet need for medical care due to cost

• "Between 1997 and 2009, among adults 18-64 years of age, the percentage who reported not receiving, or delaying, needed medical care in the past 12 months due to cost increased from 11% to 15%; the percentage not receiving needed prescription drugs due to cost rose from 6% to 11%; and the percentage not receiving needed dental care due to cost grew from 11% to 17%." Source: CDC
• "In 2009, 37% of adults 18-64 years of age who were uninsured did not receive, or delayed, needed medical care in the past 12 months due to cost, compared with 9% of adults with private coverage and 14% of adults with Medicaid." Source: CDC
• "In 2009, 19%-21% of adults 18-64 years of age in families with income below 200% of poverty did not receive needed prescription drugs due to cost in the past 12 months, compared with 12% of those with a family income 200%-399% of poverty and 4% of those with a family income 400% of poverty or higher." Source: CDC
• "In 2009, 28% of adults 18-64 years of age with any basic actions difficulty or complex activity limitation reported they did not receive needed dental care due to cost in the past 12 months, compared with 13% of adults with no disability." Source: CDC
• "In 1999, 8% of adults reported that they did not receive needed dental health services within the past 12 months because they could not afford them. By 2009, this percentage had increased to 15%." Source: CDC
• In 2009, 7% percent of children had unmet dental needs because their families could not afford dental care. Source: CDC
• An international survey conducted by the Commonwealth Fund in 2010 found that 33% of Americans went without needed care in the previous 12-month period due to cost. The survey found that 21% did not fill prescriptions or skipped doses, 22% had a medical problem but did not visit a doctor, and 22% skipped a test, treatment, or follow-up. Source: The Commonwealth Fund 2010 International Health Policy Survey in Eleven Countries

Iatrogenic deaths, injury, & disability

• "In 2002, the estimated number of [Hospital Acquired Infections] in U.S. hospitals, adjusted to include federal facilities, was approximately 1.7 million: 33,269 HAIs among newborns in high-risk nurseries, 19,059 among newborns in well-baby nurseries, 417,946 among adults and children in ICUs, and 1,266,851 among adults and children outside of ICUs. The estimated deaths associated with HAIs in U.S. hospitals were 98,987: of these, 35,967 were for pneumonia, 30,665 for bloodstream infections, 13,088 for urinary tract infections, 8,205 for surgical site infections, and 11,062 for infections of other sites." Source: CDC: Estimating Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002
• "Approximately 1 out of every 20 hospitalized patients will contract an HAI." Source: CDC.gov
• "An [Adverse Drug Event] arising from an error is considered preventable. It is difficult to get accurate measurements of how often preventable ADEs occur. One study estimated 380,000 preventable ADEs in hospitals each year, another estimated 450,000, and the committee believes that both are likely to be underestimates. The numbers are equally disturbing in other settings. One study calculates, for example, that 800,000 preventable ADEs occur each year in long-term care facilities. Another finds that among outpatient Medicare patients there occur 530,000 preventable ADEs each year. And the evidence suggests that both of these numbers are likely to be underestimates as well. Furthermore, none of these studies includes errors of omission—failures to prescribe medication in cases where it should be. Taking all of these numbers into account, the committee concludes that there are at least 1.5 million preventable ADEs that occur in the United States each year. The true number may be much higher." Source: IOM: Preventing Medication Errors
• "These medication errors are undoubtedly costly—to patients, their families, their employers, and to hospitals, health-care providers, and insurance companies—but there are few reliable estimates of that cost. One study found that each preventable ADE that took place in a hospital added about $8,750 (in 2006 dollars) to the cost of the hospital stay. Assuming 400,000 of these events each year—a conservative estimate—the total annual cost would be $3.5 billion in this one group. Another study looked at preventable ADEs in Medicare enrollees aged 65 and older and found an annual cost of $887 million for treating medication errors in this group. Unfortunately, these studies cover only some of the medication errors that occur each year in this country, and they look at only some of their costs—they do not take into account lost earnings, for example, or any compensation for pain and suffering." Source: IOM: Preventing Medication Errors
• "Health care is a decade or more behind other high-risk industries in its attention to ensuring basic safety. Aviation has focused extensively on building safe systems and has been doing so since World War II. Between 1990 and 1994, the U.S. airline fatality rate was less than one-third the rate experienced in midcentury. In 1998,there were no deaths in the United States in commercial aviation. In health care, preventable injuries from care have been estimated to affect between three to four percent of hospital patients. Although health care may never achieve aviation's impressive record, there is clearly room for improvement." Source: IOM - To Err Is Human: Building a Safer Health System
• "Two large studies, one conducted in Colorado and Utah and the other in New York, found that adverse events occurred in 2.9 and 3.7 percent of hospitalizations, respectively. In Colorado and Utah hospitals, 6.6 percent of adverse events led to death, as compared with 13.6 percent in New York hospitals. In both of these studies, over half of these adverse events resulted from medical errors and could have been prevented. When extrapolated to the over 33.6 million admissions to U.S. hospitals in 1997, the results of the study in Colorado and Utah imply that at least 44,000 Americans die each year as a result of medical errors. The results of the New York Study suggest the number may be as high as 98,000. Even when using the lower estimate, deaths due to medical errors exceed the number attributable to the 8th-leading cause of death. More people die in a given year as a result of medical errors than from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516)." Source: IOM - To Err Is Human: Building a Safer Health System
  • "The [IOM] study's most serious limitation is probably that it was a retrospective medical record review study. Many important events in patient care are not recorded in the medical record. Some errors are not even known to clinicians caring for the patient. Studies of autopsy, for example, have found potentially fatal misdiagnoses in 20% to 40% of cases. On balance, the reliance on information extracted from medical records most likely led to a substantial underestimate of the prevalence of injury." Source: JAMA: Institute of Medicine Medical Error Figures Are Not Exaggerated
  • "They undoubtedly missed some that did occur because many adverse events and errors are never recorded in the medical record, either because they are concealed or not recognized. Other errors are discovered after the patient is discharged. In fact, in the MPS, an additional 6% of hospital-caused adverse events were discovered after discharge, but were excluded from the analyses because they were an unknown fraction of all such events. Therefore, any record-review study produces at best a 'lower bound.'"
    
    Professor Leape's previous research, also cited by the Institute of Medicine report 'To Err Is Human,' has shown that typically less than five percent of known errors are reported, and many are unknown. Source: JAMA: Institute of Medicine Medical Error Figures Are Not Exaggerated
  • Second, neither of the large studies examined the extent of injuries that occur outside of the hospital. More than half of surgical procedures (numbering now in the tens of millions) take place outside of a hospital setting, and the adverse event rates for these procedures have not been studied. Even if complication and death rates are much lower than in-hospital care, the absolute numbers must be substantial, as suggested by the recent report of deaths associated with liposuction. Source: JAMA: Institute of Medicine Medical Error Figures Are Not Exaggerated
  • Third, when prospective detailed studies are performed, error and injury rates are almost invariably much higher than indicated by the large record-review studies. In a large study of patients who died from acute myocardial infarction, pneumonia, or cerebrovascular accident (conditions that account for 36% of all hospital deaths), DuBois and Brook found that 14% to 27% of deaths were preventable. Andrews et al found that 17% of intensive care unit patients had preventable serious or fatal adverse events. The Centers for Disease Control and Prevention estimates that 500,000 surgical-site infections occur each year. One large controlled study found the excess mortality rate of surgical-site infections to be 4.3%, suggesting 20,000 deaths annually from this cause alone. These data are strong evidence that record-review studies seriously underestimate the extent of medical injury. Source: JAMA: Institute of Medicine Medical Error Figures Are Not Exaggerated
• "One analysis [...] estimating adverse effects in outpatient care [...] concluded that between 4% and 18% of consecutive patients experience adverse effects in outpatient settings, with 116 million extra physician visits, 77 million extra prescriptions, 17 million emergency department visits, 8 million hospitalizations, 3 million long-term admissions, 199,000 additional deaths, and $77 billion in extra costs (equivalent to the aggregate cost of care of patients with diabetes)." Source: JAMA: Is US Health Really the Best in the World?
• "US estimates of the combined effect of errors and adverse effects that occur because of iatrogenic damage not associated with recognizable error include:
  • 12,000 deaths/year from unnecessary surgery
  • 7000 deaths/year from medication errors in hospitals
  • 20,000 deaths/year from other errors in hospitals
  • 80,000 deaths/year from nosocomial infections in hospitals
  • 106,000 deaths/year from nonerror, adverse effects of medications
  • These total to 225,000 deaths per year from iatrogenic causes. Three caveats should be noted. First, most of the data are derived from studies in hospitalized patients. Second, these estimates are for deaths only and do not include adverse effects that are associated with disability or discomfort. Third, the estimates of death due to error are lower than those in the IOM report. If the higher estimates are used, the deaths due to iatrogenic causes would range from 230,000 to 284,000. In any case, 225,000 deaths per year constitutes the third leading cause of death in the United States, after deaths from heart disease and cancer. Even if these figures are overestimated, there is a wide margin between these numbers of deaths and the next leading cause of death (cerebrovascular disease)." Source: JAMA: Is US Health Really the Best in the World?
• Required reading:
  • The Checklist
  • Why Patients Don't Report Medical Errors

Quality of Care

• "Good quality means providing patients with appropriate services in a technically competent manner, with good communication, shared decision making, and cultural sensitivity. In practical terms, poor quality can mean too much care (e.g., providing unnecessary tests, medications, and procedures, with associated risks and side effects), too little care (e.g., not providing an indicated diagnostic test or a lifesaving surgical procedure), or the wrong care (e.g., prescribing medicines that should not be given together, using poor surgical technique)." Source: How good is the quality of health care in the United States?
• "Perhaps the most striking revelation to emerge from this review is the surprisingly small amount of systematic knowledge available on the quality of health care delivered in the United States. Even though health care is a huge industry that affects the lives of most Americans, we have only snapshots of information about particular conditions, types of surgery, and locations of care.
  
  The dominant finding of our review is that there are large gaps between the care people should receive and the care they do receive. This is true for all three types of care—preventive, acute, and chronic—whether one goes for a check-up, a sore throat, or diabetic care. It is true whether one looks at overuse or underuse. It is true in different types of health care facilities and for different types of health insurance. It is true for all age groups, from children to the elderly. And it is true whether one is looking at the whole country or a single city." Source: How good is the quality of health care in the United States?
• "A simple average of the findings of the preventive care studies shows that about 50 percent of people received recommended care. (None of the studies reported a percentage of people receiving contraindicated preventive care.) An average of 70 percent of patients received recommended acute care, and 30 percent received contraindicated acute care. For chronic conditions, 60 percent received recommended care and 20 percent received contraindicated care. These values do not indicate exact levels of quality in the United States, but they do provide a quantitative sense of how much could be done in all areas to identify and eliminate overuse and underuse of care. [...]
  
  The United States cannot afford to let this situation continue. A systematic strategy for routine monitoring and reporting on quality, as well as the information systems needed to support such activities, will be essential if we are to preserve the best of the American health care system while striving to improve the efficiency with which high-quality services are provided." Source: How good is the quality of health care in the United States?
• "[34%] of U.S. patients with health problems who responded to an international survey in 2008 said that, in the last two years, a medical mistake or a medication or laboratory test error was made during their care, with the majority of respondents reporting that the mistakes occurred outside the hospital." Source: Commonwealth Fund National Scorecard on U.S. Health System Performance, 2011. Citing data from In Chronic Condition: Experiences of Patients With Complex Health Care Needs, In Eight Countries, 2008.
• "In 2007, 25 percent of elderly Medicare beneficiaries received at least one drug from a list of 13 classes of high-risk prescription drugs that experts say the elderly should avoid. [...] Among elderly adults who have one of three conditions—dementia, hip or pelvic fracture, or chronic renal failure—for which certain prescription drugs are specifically contraindicated, one of five (20%) received a drug that could produce a harmful interaction." Source: Commonwealth Fund National Scorecard on U.S. Health System Performance, 2011. Citing data from Geographic Variation in the Quality of Prescribing.
• "Inappropriate prescribing of drugs is expected to diminish as electronic prescribing is increasingly adopted as part of health information technology (HIT) systems. Such systems have the capacity to alert clinicians about potentially harmful medications or possibly dangerous interactions with other drugs or with certain diseases." Source: Commonwealth Fund National Scorecard on U.S. Health System Performance, 2011
• Required reading: Common medicines may cut cancer drug potency

Insurance

• The percentage of people without health insurance in 2010 was 16.3%. Among the non-elderly, 18.4% of individuals were uninsured. During 2010, 49.9 million Americans were without insurance. Source: HHS
• The estimated number of deaths caused due to lack of health insurance is roughly 45,000, an increase from an estimated 18,000 deaths per year in 2002. Source: Health Insurance and Mortality in US Adult, via PHNP
• "In 2007, 17.3% of persons under 65 years of age with private health insurance were enrolled in a high deductible health plan." This means that even if they were sick or in need of medical care they wouldn't necessarily be able to visit a doctor. Source: CDC
• "There also has been an increase in working-age adults who are 'underinsured,' defined as those who are insured all year but have medical bills or deductibles that are high relative to income. By 2010, 16 percent of working-age adults (an estimated 29 million) were underinsured, up from 9 percent (16 million) in 2003. Adding the underinsured to those who were uninsured during the year means that a total of 44 percent of working-age adults (81 million) were at risk in 2010, a sharp increase from 35 percent (61 million) in 2003." Source: Commonwealth Fund National Scorecard on U.S. Health System Performance, 2011. Citing analysis from Affordable Care Act Reforms Could Reduce the Number of Underinsured U.S. Adults by 70 Percent.
• "Among approximately 172 million persons under age 65 years with private health insurance, the majority of persons (73%) had some type of dental coverage. However, approximately 45 million persons [with health insurance] had no dental coverage." There are no statistics kept on what percentage of the 49.9 million Americans without health insurance have dental insurance, but presumably the answer is virtually none. Source: CDC
• One analysis of 23 million US hospitalizations found that children who were hospitalized without insurance have significantly increased all-cause in-hospital mortality as compared with children who present with insurance. "Uninsured compared with insured patients had an increased mortality risk (odds ratio: 1.60, 95% CI: 1.45-1.76). The excess mortality in uninsured children in the US was 37.8%, or 16 787, of the 38 649 deaths over the 18 period of the study." Source: Analysis of 23 million US hospitalizations: uninsured children have higher all-cause in-hospital mortality

Cost of Care

• The United States spends a larger share of its gross domestic product (GDP) on health than does any other major industrialized country. In 2007, the United States devoted 16% of its GDP to health, compared with 11% in France and 10.8% in Switzerland—the countries with the next highest shares. Source: CDC
• "Total U.S. health care expenditures are projected to increase from $2.7 trillion in 2011 to $4.7 trillion in 2021. This means that as a percentage of gross domestic product, expenditures would increase from 17.9% to 19.6%." Source: Centers for Medicare and Medicaid Services - National Health Expenditure Projections 2011-2021
• "[Health insurance] premiums for businesses and their employees increased 41 percent across states from 2003 to 2009. [...] If these trends continue at the rate prior to enactment of the Affordable Care Act, the average premium for family coverage will rise 79 percent by 2020, to more than $23,000. [...] If reforms succeed in slowing premium growth by 1 percentage point annually in all states, by 2020 employers and families together will save $2,323 annually for family coverage, compared with projected trends." Source: State Trends in Premiums and Deductibles, 2003-2009: How Building on the Affordable Care Act Will Help Stem the Tide of Rising Costs and Eroding Benefits, via Commonwealth Fund National Scorecard on U.S. Health System Performance, 2011
• "Premiums have gone up even while employers have asked workers to pay a greater share of health care costs—in the form of deductibles and copayments—or have reduced the generosity of benefits in an effort to moderate annual premium growth. [...] Not only do 74 percent of workers now have a deductible, compared with 52 percent in 2003, but per-person deductibles for private-employer health plans increased 77 percent on average from 2003 to 2009." Source: State Trends in Premiums and Deductibles, 2003-2009: How Building on the Affordable Care Act Will Help Stem the Tide of Rising Costs and Eroding Benefits, via Commonwealth Fund National Scorecard on U.S. Health System Performance, 2011
• "In addition to unsustainable cost growth, there is evidence that a substantial proportion of health care expenditures is wasted, leading to little improvement in health or in the quality of care. Estimates vary on waste and excess health care costs, but they are large. The IOM workshop summary The Healthcare Imperative: Lowering Costs and Improving Outcomes contains estimates of excess costs in six domains: unnecessary services [$210B], services inefficiently delivered [$130B], prices that are too high [$105B], excess administrative costs [$190B], missed prevention opportunities [$55B], and medical fraud [$75B]. [...]
  
  Although these estimates have unknown overlap, the sum of the individual estimates—$765 billion—suggests the significant scale of waste in the system. Two other independent and differing analytic approaches—considering regional variation in costs and comparing costs across countries—produce similar estimates, with total excess costs approaching $750 billion in 2009 (Farrell et al., 2008; IOM, 2010; Wennberg et al., 2002). While there are methodological issues with each method for estimating excess costs, the consistently large figures produced by each signal the potential for reducing health care costs while improving quality and health outcomes.
  
  At this level, health care waste exceeds the 2009 budget for the Department of Defense by more than $100 billion (OMB, 2010). Health care waste also amounts to more than 1.5 times the nation's total infrastructure investment in 2004, including roads, railroads, aviation, drinking water, telecommunications, and other structures. To put these estimates in the context of health care expenditures, the estimated redirected funds could provide health insurance coverage for more than 150 million workers (including both employer and employee contributions), which exceeds the 2009 civilian labor force."
Source: Best Care at Lower Cost: The Path to Continuously Learning Health Care in America p. S-7
• Required reading: Bitter Pill: Why Medical Bills Are Killing Us

Health Literacy

• "More than 300 studies indicate that health-related materials far exceed the average reading ability of U.S. adults." Source: Health Literacy: A Prescription to End Confusion
• "90 million adults with limited health literacy cannot fully benefit from much that the health and health-care system have to offer." Source: Health Literacy: A Prescription to End Confusion
• A two-year-old is diagnosed with an inner ear infection and prescribed an antibiotic. Her mother understands that her daughter should take the pre- scribed medication twice a day. After carefully studying the label on the bottle and deciding that it doesn't tell how to take the medicine, she fills a teaspoon and pours the antibiotic into her daughter's painful ear. Source: Health literacy: a policy challenge for advancing high-quality health care., via Health Literacy: A Prescription to End Confusion
• "Efforts to improve quality, to reduce costs, and to reduce disparities cannot succeed without simulta- neous improvements in health literacy." Source: Health Literacy: A Prescription to End Confusion

Antibiotic Resistance

• "No country, including the United States, has a reliable, longitudinal, full-service antimicrobial resistance surveillance program with comprehensive focus, nor is there a comprehensive database for monitoring trends in antimicrobial usage. Research and information on the impact of rapidly increasing antimicrobial resistance in the community are lacking. Antibiotic use is widespread not just in hospital and community settings, but on the farm, yet knowledge of the magnitude of all these uses depends largely on estimation and extrapolation. Multiple surveillance activities around the globe are attempting in different ways and at different speeds to move toward the ideal depicted in this report, but these systems, as a group, are uncoordinated and unstandardized. Thus, the magnitude of the resistance problem and its impact are really unknown and may be considerably understated." Source: IOM Workshop: Antiomicrobrial Resistance— Issues and Options
• "Penicillin-resistant strains of Staphylococcus aureus were isolated as early as 1945. By 1959, there was already enough evidence of resistance to stimulate a review article in the Journal of the American Medical Association. The sense of urgency among Forum members was provoked by the acceleration and accumulation of a number of variables, expressed as documented increases in:
  • the number of pathogens displaying resistance and, within these, a mounting number of multidrug-resistant strains;
  • the number of compromised hosts;
  • mortality attributable to antimicrobial resistance;
  • the speed with which resistant microbes can spread globally; and
  • the costs of health care deriving from resistant microbes.
  These increases were, in turn, accompanied by decreases or limitations in:
  • the power of the antimicrobial armamentarium to deal with many resistant pathogens,
  • the amount of research and development dedicated to antimicrobials during a period when resistance was not generally seen as a major threat, and
  • funding for public health infrastructure."
  Source: IOM Workshop: Antiomicrobrial Resistance— Issues and Options
• "In 1992, 23.6 million courses of outpatient antimicrobial therapy were prescribed in the United States for otitis media; another 17.9 million courses were prescribed for upper respiratory infections, 16.3 million for bronchitis, 13.1 million for pharyngitis, and 12.9 for sinusitis. This is true even though the large majority of these infections are of viral etiology and therefore not responsive to antibiotics." http://www.nap.edu/openbook.php?record_id=6121&page=42
• Among children who saw a doctor for a sore throat during 2010, 22 percent in HMO health plans and 35 percent in Medicaid plans were prescribed an antibiotic without a 'strep' test to determine first whether they had a bacterial infection warranting antibiotic treatment. Source: Commonwealth Fund National Scorecard on U.S. Health System Performance, 2011. Updated with 2010 data from NCQA - The State of Health Care Quality (2010), p. 85.
• "Applying two different Consumer Price Index (CPI) adjustments to account for the rate of inlation in hospital resource prices, the overall annual direct medical costs of HAI to U.S. hospitals ranges from $28.4 to $33.8 billion (after adjusting to 2007 dollars using the CPI for all urban consumers) and $35.7 billion to $45 billion (after adjusting to 2007 dollars using the CPI for inpatient hospital services). After adjusting for the range of effectiveness of possible infection control interventions, the beneits of prevention range from a low of $5.7 to $6.8 billion (20 percent of infections preventable, CPI for all urban consumers) to a high of $25.0 to $31.5 billion (70 percent of infections preventable, CPI for inpatient hospital services)." Source: The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention
• Farm animals use 80% of antibiotics in the United States. Source: New FDA Numbers Reveal Food Animals Consume Lion's Share of Antibiotics, via Wired.
• Required reading:
  • U.S. Tightens Rules on Antibiotics Use for Livestock
  • FDA's New Rules on Factory Farm Antibiotics Are Flawed—and Voluntary
  • Court Scolds FDA Over Ag Antibiotic Use
  • Antibiotics and Antibiotic-Resistant Bacteria in Meat: Not Getting Better
  • Health chief warns: age of safe medicine is ending

Medical Adherence

• "The average nonadherence rate is 24.8%. Controlling for intercorrelations among moderator variables, adherence is significantly higher in more recent and smaller studies and in those involving medication regimens and adult samples. [...] Adherence is highest in HIV disease, arthritis, gastrointestinal disorders, and cancer, and lowest in pulmonary disease, diabetes, and sleep." Source: Variations in Patients' Adherence to Medical Recommendations
• "Adherence has been found to vary by disease condition but often is lowest among patients with the very conditions for which adherence would be most effective." Source: Improving patient adherence: a three-factor model to guide practice
• "Compared with nondepressed patients, the odds are 3 times greater that depressed patients will be noncompliant with medical treatment recommendations." Source: Depression Is a Risk Factor for Noncompliance With Medical Treatment
• "Practical support bears the highest correlation with adherence. Adherence is 1.74 times higher in patients from cohesive families and 1.53 times lower in patients from families in conflict." Source: Social Support and Patient Adherence to Medical Treatment: A Meta-Analysis
• "Applying a nonadherence prevalence rate of 24.8% suggests that as many as 188.3 million medical visits (over 53 million of which are publicly funded) result in patients not following the advice they are given. [...] This is not to say that patients necessarily should follow the advice they are given, or that it is the fault of patients or their health professionals when they do not. It is suggested, however, that something could be wrong with an expensive system of service delivery in which one of its primary products, advice, so often remains unused." "Source: Variations in Patients' Adherence to Medical Recommendations
• "Analysis of specific diseases (visits per year times prevalence rate of nonadherence) yields the following estimates of the number of visits probably ending in nonadherence: 8.4 million for hypertension, 7.6 million for diabetes, and 4.5 million for cancer. Analysis by regimen suggests the following: 112.2 million for medication, 49.4 million for diet; and 22.6 million for exercise recommendations." Source: Variations in Patients' Adherence to Medical Recommendations
• Required Reading: Health Behavior Change and Treatment Adherence: Evidence-based Guidelines for Improving Healthcare

Required Reading

• Why you should not go to medical school — a gleefully biased rant
• Is aging a disease?
• Ina May Gaskin and the Battle for at-Home Births
• Chinese Melamine and American Vioxx: A Comparison
• Holding Birth Control Hostage
• Is US Health Really the Best in the World?
• What exactly is Obamacare and what did it change?
• The Death of Ivan Ilyich and pain relief at the end of life
• Medical devices: A ticking time-bomb
• Computer Viruses Are 'Rampant' on Medical Devices in Hospitals
• Accuracy of Home Glucose Monitors Questioned
• Believing in Treatments That Don't Work
• Doctors Urge Their Colleagues To Quit Doing Worthless Tests
• Cancer Survivor or Victim of Overdiagnosis?
• Why Not the Best?

Pharmaceuticals

Drug Approval Statistics

• "The number of clinical trials under way in any given year is staggering. In 2001, an estimated 80,000 of them were ongoing in the United States alone. That year, about 2.3 million Americans served as human subjects. These numbers are only approximate. Exact figures are hard to come by, since not all trials are registered with the FDA or NIH." Source: The Truth About Drug Companies, p. 29
• "In the five years from 1998 through 2002 [...] 415 new drugs were approved -- an average of 83 per year. Of those, 133 (32 percent) were new molecular entities. The others were variations of old drugs. And of those 133, only 58 were priority review drugs. That averages out to no more than 12 innovative drugs per year, or 14 percent of the total." Source: The Truth About Drug Companies, p. 55
• Between 1938 and 2006, a total of 11,714 new drugs were approved by the FDA. Of these, 1,408 (12%) were new molecular entities. The rest were new combinations or dosages of existing drugs. Source: Summary of NDA Approvals & Receipts, 1938 to the present
• In the five years between 2007 and 2011, a total of 119 New Molecular Entities were approved by the FDA. Of these, only 50 were granted priority review, meaning they were classified by the FDA as having the potential to provide a therapy where none exists or providing a therapy which may be potentially superior to existing therapy. Of these 50 priority NMEs, 30 were orphan drugs, meaning they were approved for diseases that affect 200,000 or fewer Americans. Source: NME Drug and New Biologic Approvals
• "Over the four years beginning in 2000, there were just 32 innovative drugs out of a total of 314 approved drugs. Even in this small collection, only seven came from the top ten U.S. drug companies." Source: The Truth About Drug Companies, p. 234

Selective Enrollment

• "[One] way to load the dice is to enroll only young subjects in trials, even if the drugs being tested are meant to be used mainly in older people. Because young people generally experience fewer side effects, drugs will look safer in these trials than they would in practice. Another is to compare the new drug not just with a placebo but with an old drug given at too low a dose. [...] This bias was [...] present in many trials of nonsteroidal anti-inflammatory drugs (NSAIDS). (These are drug like Naprosyn that are taken mainly for arthritis.) These new NSAIDS looked better because the comparison drugs were given at lower doses. Or the old drugs can be administered incorrectly. That was true of trials comparing fluconazole with an older drug, amphotericin B, to treat fungus infections in patients with AIDS. Amphotericin B was administered orally, which dramitaclly cuts down on its effectiveness. Not surprisingly, the trials were sponsored by fluconazole. Or trials can be designed to be too brief to be meaningful. That is true of many trials that need to be taken long term. Blood pressure trials usually last for just a few months, and antidepressant trials for a few weeks, yet patients may have to take these kinds of drugs for years. Some treatments look pretty good for a short time but are not effective and may even be harmful for longterm use." Source: The Truth About Drug Companies, p. 108
• "One of the main reasons for excluding patients from clinical trials is to make it easier to find differences between the drug and the placebo. There are two ways in which excluding some patients from the trials can help accomplish this aim. One is to eliminate those who are most likely to respond to a placebo. To accomplish this goal, patients are excluded from clinical trials if they have only been depressed for a short time, if they are only mildly depressed or if they respond to placebo treatment during the placebo run-in phase.
  
  The second way in which excluding patients from clinical trials can magnifiy drug-placebo differences is by getting rid of patients who are not likely to respond well enough to the active drug. This is the reason for excluding patients who have been depressed for a very long period of time, who have no responded to previous treatments, who abuse alcohol or other drugs or who, besides being depressed, also suffer from an anxiety or personality disorder or from various medical disorders. Patients with these characteristics do not seem to respond as well as others to drug treatment. The exclusion criteria used in clinical trials make it difficult to know exactly how well antidepressants work in the broader population of depressed patients in clinical practice, but if there is a bias, it favours the drugs rather than the placebo, because the purpose of excluding these patients is to increase drug-placebo differences so as to make the drug effect easier to detect." Source: The Emperor's New Drugs, p. 72
• "To get human subjects, drug companies or contract research organizations routinely offer doctors large bounties (averaging about $7000 per patient in 2001) and sometimes bonuses for rapid enrollment. For example, according to a 2000 Department of Health and Human Services inspector general's report, physicians in one trial were paid $12,000 for each patient enrolled, plus another $30,000 on the enrollment of the sixth patient. One risk of this bounty and bonus system is that it can induce doctors to enroll patients who are not really eligible. For instance, if it means an extra $30,000 to you to enroll a patient in an asthma study, you might very well be tempted to decide your next patient has asthma, whether he does or not ('Sounds like a little wheeze you have there...'). Obviously, if the wrong patients are enrolled, the results of a trial are unreliable, and that is probably often the case." Source: The Truth About Drug Companies, p. 30
• "Ideally, people included in a trial reflect the population of patients to whom the results will be applied -- those most likely to use the drug or device being tested. But this is not always the case. [...] Many studies choose a population that is younger and fitter than the target population, and therefore less likely to show side effects. An editorial in the Canadian Medical Association Journal pointed out that only 2.1 percent of all patients in studies of anti-inflammatory drugs are over the age of 65; yet senior citizens, the editorial points out, 'are among the largest users' of these drugs and are more likely to have serious complications from them. The editorial also indicts research on drugs for Alzheimer's disease: A study to determine the effectiveness of one such drug, Aricept, restricted the range of patients to age 65 to 74 and excluded people with other medical problems besides Alzheimer's disease, thus minimizing the likelihood of side effects. The problem is that the vast majority of patients for whom this drug will be prescribed are older than this, and therefore the results of the study do not apply to them. As the editorial pointed out, 'If frail older patients are going to be targeted for dementia therapy we need to study this group in clinical trials to ensure the safe administration of the drug.'
  
  Studies of cancer drugs are similar. Nearly two-thirds of all cancer patients are 65 or older, but only one-quarter of the people in cancer studies have reached 65. Most of these studies exclude older patients by requiring that participants be able to take care of themselves independently or be able to work. Conducting research on only the strogest subset of cancer patients is not a good way to find out how to treat most cancer patients. Perhaps older people will have more severe reactions or derive less (or possible more) benefit from the cancer therapies being tested. In any event, the systematic inclusion of unrepresentative patients in clinical studies may be good for the profits of the commercial sponsors of the studies (at least in the short term), but it is not good for the people who will receive care based on this distorted 'science.'" Source: Overdosed America, p. 104, citing The Evolution of Clinical Trials: Inclusion and Representation, and Too Few Older Patients in Cancer Trials: Experts Say Disparity Affects Research Results and Care
• "One study from 2007 took 179 representative asthma patients from the general population and looked at how many would have been eligible to participate in a group of asthma treatment trials. The answer was 6 per cent on average, and these weren't any old trials they were being rejected from: they were the trials that form the basis of the international consensus guidelines for treating asthma in GP clinics and hospitals. These guidelines are used around the world, and yet, as this study shows, they are based on trials that would have excluded almost every single real-world patient they're applied to.
  
  Another study took six hundred patients being treated for depression in an outpatient clinic, and found that on average only a third of them would have been eligible to participate in thirty-nine recently published trials of treatments for depression. People often talk about the difficulties in recruiting patiens for research: but one study described how 186 patients with depression enquired about participating in two different trials of antidepressants, and more than seven out of every eight had to be turned away because they weren't eligible." Source: Bad Pharma, p. 177, citing External validity of randomised controlled trials in asthma: to whom do the results of the trials apply? , Exclusion criteria used in antidepressant efficacy trials: consistency across studies and representativeness of samples included., How many subjects with major depressive disorder meet eligibility requirements of an antidepressant efficacy trial?
• "[Drug study] volunteers come from less well-off groups in society, and this means that drugs taken by all of us are tested — to be blunt — on the poor. In the US, this means people without medical insurance, and that raises another issue: the Declaration of Helsinki, the ethics code which frames modern medical activity, says that research is justified if the population from whom participants are drawn would benefit from the results. A new AIDS drug shouldn't be tested on people in Africa, for example, who could never afford to buy it. But uninsured unemployed people in the US do not have access to expensive medical treatments either [...] so it's not clear that they could benefit from this research. On top of that, most agencies don't offer free treatment to injured subjects, and none give them compensation for suffering or lost wages.
  
  This is a strange underworld that has been brought to light for the academic community by Carl Elliot, an ethicist, and Robert Abadie, an athropologist who lived among phase I participents for his PhD. The industry refers to these participants by the oxymoron 'paid volunteers', and thre is a universal pretence that they are not paid for their work, but merely reimbursed for their time and travel expenses. The participants themselves are under no such illusions.
  
  Payment is often around $200 to $400 a day, studies can last for weeks or more, and participants will often do several studies in a year. Money is central to the process, and payment is often back-loaded, so you only receive full payment if you complete the study, unless you can prove your withdrawal was due to serious side effects. Participants generally have few economic alternatives, especially in the US, and are freqently presented with lengthy and impenetrable consent forms, which are hard to navigate and understand.
  
  You can earn better than minimum wage if you 'guinea pig' full-time, and many do: in fact, for many of them it's a job, but it's not regulated as any other job might be. This is perhaps because we feel uncomfortable regarding this source of income as a profession, so new problems arise. Participants are reluctant to complain about poor conditions, because they don't want to miss out on future studies, and they don't go to lawyers for the same reason. They may be disinclined to walk away from studies that are unpleasant or painful, too, for fear of sacrificing income. One participant describes this as 'a mild torture-economy': 'You're not being paid to do a job... you're being paid to endure.'" Source: Bad Pharma, p. 106, citing The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects
• "In the past, only 15 per cent of clinical trials were conducted outside the USA. Now it's more than half. The average rate of growth in the number of trials in India is 20 per cent a year, in China 47 per cent, in Argentina 27 per cent, and so one, simply because they are better at attracting CRO business, at lower cost. At the same time, trials in the US are falling by 6 per cent a year (and in the UK by 10 per cent a year). As a result of these trends, many trials are now being conducted in developing countries, where regulator oversight is poorer, as is the normal standards of clinical care. This raises a huge number of questions about data integrity, the relevance of findings to developed world populations, and ethics — all issues with which regulators around the world are currently struggling.
  
  There are many anecdotal accounts of bad behaviour with trial data in poorer countries, and it's clear that the incentives for massaging results are greater in a country where a clinical trial is paying its subjects vastly more than local wages could match. There are also difficulties with regulatory requirements that fall across two countries or two languages, as well as translation issues in patient reports, especially for unexpected side effects. Site visits for monitoring may be of variable quality, and countries differ in how much corruption is routine in public life. There may also be less local familiarity with administrative requirements concerning data integrity (which have been a bone of contention between industry and regulators in the developed world).
  
  These are, we should be clear, only hints of problems with data. There have been cases where trials from developing countries have produced positive results, while those conducted elsewhere showed no benefit, but to the best of my knowledge, very little quantitative research has so far been conducted comparing the results of trials in poorer countries with those in the US and Western Europe. This means we can draw no firm conclusions on data integrity." Source: Bad Pharma, p. 113, citing Trends in the globalization of clinical trials
  • See also: 'Explosive' Growth in Foreign Drug Testing Raises Ethical Questions

Manipulation of Statistical Tests

• "All of the trials we analysed had what is called a placebo 'run-in' or 'wash-out' phase. The way this works is as follows. After people are assessed for inclusion in the trial, they are all given a placebo for a week or two. After this run-in period, the patients are reassessed, and anyone who has improved is excluded from the trial. [...]
  
  By getting rid of the patients who show a placebo response to the medication that is being investigated, the run-in should make the drugs look more effective than the really are. This is a potential flaw in clinical-trial methodology that biases the trials in favour of the drug and against the placebo. It is also an ethically questionable practice. Patients are not told that they will definitely be put on a placebo for a while, nor are they told this at the debriefing at the end of the study. So the placebo run-in is a violation of the requirement for informed consent.
  
  Sandra Lee and her colleagues at St Boniface General Hospital in Winnipeg, Canada, analysed the effect of included a placebo run-in period and excluding patients who get better from the trial. Although placebo run-ins tended to produce larger drug effects, the difference was not statistically significant. Part of the problem was that there were relatively few studies that did not have a run-in phase. This makes it very difficult for a difference to reach statistical significance. The authors concluded that 'from a scientific standpoint, there is no reason to use the placebo run-in phase to eliminate placebo responders because it is costly in terms of time and effort'. But they also predicted that the practice of using placebo run-in periods will continue, because they do in fact seem to produce larger drug effects." Source: The Emperor's New Drugs, p. 69, citing the journal article Does elimination of placebo responders in a placebo run-in increase the treatment effect in randomized clinical trials? A meta-analytic evaluation.
• "In five trials on pregabalin and pain, lots of people dropped out during the study period. This is common in medical trials, as you will shortly see, and it often happens because people have found a drug to be unhelpful, or have had bad side effects. During these trials you're measuring pain at regular intervals. But if some people drop out, you're left with an important question: what kind of pain score should you use for them in your results? We know, after all, that people dropping out are more likely to have done badly on the drug.
  
  Pfizer decided to use a method called 'Last Observation Carried Forward', which means what you'd expect: you take the last measurement of pain severity while the patients were on the drug, from just before they dropped out, and then paste that in for all the remaining pain measures that they missed, after they stopped coming to follow-up appointments.
  
  The FDA disapproved of this: it pointed out, quite correctly, that Pfizer's strategy would make the drug look better than it really is. For a fairer picture, we have to assume that the dropouts stopped taking the drug because of side effects, so their pain score should reflect the reality, which is that they would never get any benefit from the drug in normal use. The correct level of pain for them is, therefore, their pain at the beginning of the study, before they had any kind of treatment (if you're interested, this is called 'Baseline Observation Carried Forward'). The analysis was duly redone, properly, and a more modest, more accurate view of the benefits of the drug was produced. In this case, it turns out that using the 'last observation' method overestimated the improvement in pain by about a quarter.
  
  Here's the catch. Four out of five of these trials were then published in peer-reviewed academic literature, the place where doctors look for evidence on whether a drug works or not (one trial wasn't published at all). Every single one of the published analyses used 'Last Observation Carried Forward', the dodgy method, the one that exaggerates the benefits of the drug. Not one of them acknowledges that 'last observation' is a technique that overstates the benefits." Source: Bad Pharma, p. 68
• "One thing that's likely to make your new treatment look good is testing it against something that doesn't work very well: this might sound absurd, or even cruel, so we're lucky that a researcher called Daniel Safer has pulled together a large collection of trials using odd doses specifically to illustrate this problem. One study, for example, compares paroxetine against amitryptiline. Paroxetine is one of the new antidepressants, and it is largely free from side effects like drowsiness. Amitryptyline is a very old drug, known to make people sleepy, so in real clinical practice it's often best to advise patients to take it only at night, because drowsiness doesn't matter so much when you're asleep. But in this trial amitryptyline was given wice a day, morning and night. The patients reported lots of daytime sleepiness on amitryptyline, making paroxetine look much better.
  
  Alternatively, some trials compare the expensive new drug against an older one given at an unusually high dose, which means it has worse side effects by comparison. [...] Safer found six trials comparing new-generation antipsychotic drugs with boring old-fashioned haloperidol — a drug well known to have serious side effects — at 20mg a day. This is not an insanely high dose of haloperidol: it wouldn't get you immediately struck off, and it's not entirely outside the maximum dose permitted in the British National Formulary (BNF), the standard reference manual for drug prescription. But it's an odd routine dose, and it's inevitable that patients receiving so much would report lots of side effects.
  
  Interestingly, a decade later, history repeated itself: risperidone was one of the first of this new generation of antipsychotic drugs, so it came off patent first, immediately becoming very cheap, like the older generation of drugs. As a consequence, many drug companies wanted to show that their own expensive new-generation antipsychotic was better than risperidone, which was now suddenly cheap and old-fashioned: and so trials appeared comparing new drugs against risperidone at a dose of 8mg. Again, 8mg isn't an unimaginably high dose: but it's still pretty high, and patients on this dose of risperidone will be much more likely to report side effects, making the comparator drug look more attractive.
  
  This — again — is quite a diffuse scandal. It doesn't mean that any of these specific drugs are outright, headline-grabbing killers: just that the evidence, overall, is distorted." Source: Bad Pharma, p. 181, citing Design and reporting modifications in industry-sponsored comparative psychopharmacology trials.
• "A review from 2010 took around a hundred truncated trials, and four hundred matched trials that ran their natural course to the end: the truncated trials reported much bigger benefits, overstating the usefulness of the treatments they were testing by about a quarter. Another recent review found that the number of trials stopped early has doubled since 1990, which probably is not good news. At the very least, results from trials that stop early should be regarded with a large dose of skepticism. Particularly since these same systematic reviews show that trials which stop early often don't properly report their reasons for doing so." Source: Bad Pharma, p. 186, citing Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis., Randomized trials stopped early for benefit: a systematic review.
• "In 2004, some researchers published a paper looking at all areas of medicine: they took all the trials approved by the ethics committes of two cities over two years, then chased up the published papers. About half of all the outcomes were incorrectly reported. Of the published papers, almost two thirds had been switched, and this was not being done at random: exactly as you'd expect, positive outcomes were more than twice as likely to be properly reported. Other studies on primary-outcome switching report similar results.
  
  To be clear: if you switch your pre-specified primary outcome between the beginning and the end of your trial, without a very good explanation for why you've done so, then you're simply not doing science properly. Your study is broken by design. It should be a universal requirement that all studies report their pre-specified primary outcome as the primary outcome. This should be enforced by all journals, and things should have been done this way since trials began. It's really not difficult. Yet we have collectively failed to adhere to this simple, obvious core requirement on an epic scale." Source: Bad Pharma, p. 203, citing Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.

Efficacy Requirements

• "The efficacy criterion used by drug regulators requires two 'adequate and well-controlled' clinical trials showing that a drug is better than a placebo. But there are some catches. The first catch is that there is no limit to the number of studies that can be run in order to find the two showing a statistically significant effect. Negative trials don't count. The second catch is that the size of the drug-placebo differents -- its clinical significance -- is not considered [...].
  
  The FDA approval of citalopram (Cipramil) provides a convenient example of how this works. Seven placebo-controlled efficacy trials were conducted. Two showed small but significant differences between drug and placebo. Another two trials failed to show significant differences, but were deemed too small to count. Three other trials that were deemed adequate and well controlled also failed to show significant drug-placebo differences. For each of them, the leader of the FDA new drug application team stated that 'the reasons for the negative outcome for this study are unknown', and for two of them he added that 'there was a substantial placebo response, making it difficult to distinguish drug from placebo'. In his summary of these three negative trials, the team leader wrote, 'I feel there were sufficient reasons to speculate about the negative outcomes and, therefore, not count these studies against citalopram.' Agreeing with this assessment, the Division Director concluded that 'there is clear evidence from more than one adequate and well controlled clinical investigation that citalopram exerts an antidepressant effect'. This, in my opinion, is voodoo science. The drug companies can conduct as many trials as they want until they find two showing significant effects. The negative trials simply don't count.
  
  Even with five negative trials discounted, the size of the drug-placebo difference for citalopram was small. It averaged only two points on the Hamilton scale, well below the three-point difference that NICE uses as its criterion for clinical significance. The FDA reviewers recognized that the difference was small. The team leader wrote that 'while it is difficult to judge the clinical significance of this difference, similar findings for other SSRIs and other recently approved antidepressants have been considered sufficient to support the approvals of those other products'. So citalopram was approved as well." Source: The Emperor's New Drugs, p. 51
• "In the five years from 1998 through 2002, 415 new drugs were approved by the Food and Drug Administration (FDA), of which only 14 percent were truly innovative [(granted priority review by the FDA, see above)]. A further 9 percent were old drugs that had been changed in some way that made them, in the FDA's view, significant improvements. And the remaining 77 percent? Incredibly, they were all me-too drugs -- classified by the agency as being no better than drugs already on the market to treat the same condition. Some of these had different chemical compositions from the originals; most did not. But none were considered improvements. [...]
  
  This travesty is made possible by one crucial weakness in the law -- namely, drug companies have to show the FDA only that new drugs are 'effective.' They do not have to show that they are more effective (or even as effective as) what is already being used for the same condition. They just have to show they are better than nothing. And that is exactly what the companies do. In clinical trials, they compare their new drugs with placebos (sugar pills) instead of with the best current treatment. That is a very low hurdle indeed. In fact, on the basis of placebo-controlled trials, drugs can be approved that are actually worse than drugs already on the market. The last thing drug companies want is a head-to-head comparison. Only when it would be clearly dangerous to human subjects to deprive them of treatment by using a placebo are drug companies likely to compare a new treatment with an old one. That doesn't happen very often.
  
  This defect in the law is critical in understanding the modern pharmaceutical industry. Almost alone, it has enabled the industry to transform itself into a giant me-too business. If companies had te show their drugs were better than older treatments, there would be far fewer me-too drugs, because not many of them would pass that test. The companies would have no choice but to look for important new drugs, instead of taking the easier and cheaper route of spinning out old ones." Source: The Truth About Drug Companies, p. 75
• "A paper from 2011 looked at the evidence supporting every single one of the 197 new drugs approved by the FDA between 2000 and 2010, at the time they were approved. Only 70 per cent had data to show they were better than other treatments (and that's after you ignore drugs for conditions for which there was no current treatment). A full third had no evidence comparing them with the best currently available treatment, even though that's the only question that matters to patients." Source: Bad Pharma, p. 131, citing Availability of Comparative Efficacy Data at the Time of Drug Approval in the United States
• Often new drugs are granted accelerated approval without sufficient evidence of efficacy, on the condition that the pharmaceutical company conducts further trials after approval. Ben Goldacre writes, "The General Accounting Office is the investigative audit branch of the US Congress. In 2009, it examined the FDA's failure to chase these kinds of post-approval studies, and its findings were damning: between 1992 and 2008, ninety drugs had been given accelerated approval on the basis of surrogate endpoints alone, with the drug companies making a committment to conduct 144 trials in total. As of 2009, one in every three of those trials was still outstanding. No drug had ever been taken off the market because its manufacturer had failed to hand over outstanding trial data." Source: Bad Pharma, p. 140, citing New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints
• See also: The Institute of Medicine's report Initial National Priorities for Comparative Effectiveness Research, its list of the 100 most-important areas of medicine where we don't know which treatment options are most effective.

Relapse Prevention Studies

• "Defenders of antidepressants cite 'relapse prevention' or 'discontinuation' trials to support their contention that the real magnitude of the drug effect requires longer trials to become evident. Relapse-prevention trials are designed to assess what happens when patients are taken off medication. They work like this: patients who have responded reasonably well to the active medication are either kept on the drug or switched to a placebo. Then relapse rates are compared. Relapse-prevention trials generally show that switching patients to a placebo leads them to get worse, compared to those who stay on the active drug.
  
  Now there are a number of problems with relapse-prevention studies. One is the fact that many people who are taken off antidepressants experience withdrawal symptoms, which in severe cases can last for months. Some of these withdrawal symptoms -- sadness, suicidal thoughts, crying spells, trouble concentrating, irritability, anxiety, agitation and insomnia, for example -- are also symptoms of depression. These withdrawal symptoms could lead both patients and researchers to think that the patient has relapsed.
  
  In addition to being mistaken for relapse, antidepressant withdrawal symptoms might induce a real relapse. Imagine that you are a depressed patient who has been helped by an antidepressant. As part of a relapse-prevention study, the drug is withdrawn and you are given a placebo. Shortly thereafter you begin to feel sad, depressed, anxious and agitated. These were all symptoms you experienced when you were depressed. In addition, you now begin to experience new symptoms that you have never felt before. You feel nauseous, dizzy, your vision blurs and your muscles twitch. Not knowing that all of these are symptoms of antidepressant withdrawal, you may think you have relapsed and become even worse than you were before beginning medication. Misinterpreting withdrawal symptoms as an indication of relapse could initiate a vicious cycle leading to a genuine relapse.
  
  A second problem with relapse-prevention trials is related to research suggesting that the use of antidepressants might make people more vulnerable to relapse. Patients who are being treated with antidepressants show a specific vulnerability to relapse that is not shown by recovered patients who have been treated without drugs. So the relapses suffered in relapse-prevention trials may be due to a biological vulnerability that has been induced by the medication in the first place." Source: The Emperor's New Drugs, p. 63

Statistical vs Clinical Significance

• "When researchers report that a difference is significant, what they usually mean is that the difference is significant statistically. Statistical significance refers to whether an effect -- the difference between a drug and a placebo, for example -- is real, or whether it has occurred just by chance. It tells you how likely you are to get the same results if you do the same study over again. But it does not tell you how large or important the effect is. Whether a diference is statistically significant depends on a number of factors, including the number of people that were included in the study. The larger the study, the easier it is to find statistical differences. If the study is large enough, even very tiny differences will be statistically significant. Conversely, the smaller the study, the harder it is to find differences that are statistically significant. With very small studies, even relatively large effects might not be significant statistically. It is like a seesaw. When the size of the study goes up, the criterion for statistical signifance goes down; and when the size of the study goes down, the criterion for statistical significance goes up.
  
  To evaluate the importance of the difference of an effect, you have to look at the clinical significance of the findings. Unlike statistical significance, clinical significance refers to the size of the effect. It adresses whether it is likely to make a meaningful difference in anyone's life. An example might help clarify this. Imagine that as tudy has been conducted on 500,000 people and has found that smiling increases life expectancy. This seems very impressive, but on reading further you discover that it increases life expectancy by only ten seconds. With 500,000 subjects, the effect is likely to be statistically significant, but it is not clinically meaningful." Source: The Emperor's New Drugs, p. 28
• "It is not enough to show that [drugs] are statistically better than placebos. For drugs to be marketed and for patients to be exposed to their side effects and other risks, the benefit over placebos needs to be shown to be clinically significant. In the files I obtained from the FDA, agency officials acknowledged the failure to show a clinically siginificant benefit from the drugs they have approved, saying instead that they demonstrate 'proof in principle' of the effectiveness of the drugs. What proof in principle means is simply that the drugs are statistically superior to placebos, even if the difference is vanishingly small. In approving Cipramil (Celexa in the US), the Director of the FDA Division of Neuropharmacological Drug Products summarized the situation as follows:
  
  'The size of [the] effect, and more importantly, the clinical value of that effect, is not something that can be validly measured, at least not in the kind of experiments conducted. Accordingly, substantial evidence in the present case, as it has in all other evaluations of antidepressant effectiveness, speaks to proof in principle of a product's effectiveness.'
  
  And the Team Leader for Psychiatric Drug Products commented, 'While it is difficult to judge the clinical significance of this difference, similar findings for other SSRIs and other recently approved antidepressants have been considered sufficient to support the approvals of those other products.' In other words, the 'clinical value' of an antidepressant drug is just not part of the FDA's criteria for approving it." Source: The Emperor's New Drugs, p. 74

Hiding Bad Data

• "When a drug company applies to the FDA for approval of a new drug, it is required to submit results from every one of the clincial trials it has sponsored. But it is not required to publish them. The FDA may approve the drug on the basis of minimal evidence. For example, the agency usually requires simply that the drug work better than a placebo in two clinical trials, even if it doesn't in other trials. But companies publish only positive results, not the negative ones. Often, in fact, they publish positive results more than once, in slightly different forms in different journals. The FDA has no control over this selective publishing. The practice leads doctors to believe that drugs are much better than they actually are, and the public comes to share this belief, on the basis of media reports. There is a general inflation in the notion of the good that drugs can do (and a deflation in concern about side effects)." Source: The Truth About Drug Companies, p. 112
• "The failure to publish unsuccessful trials presents a problem in many research areas. When a study has produced non-significant results, it is less likely to be submitted for publication; and, if it is submitted, it is less likely to be favourably reviewed or accepted for publication. But although publication bias affects all areas of research to some extent, it is particularly acute when it comes to drug trials. This is because most of the clinical trials evaluating medications are financially sponsored by the companies that produce and stand to profit from them. The companies own the data that come out of trials they sponsor, and they can choose how to present them to the public -- or to withhold them and not present them to the public at all. With widely prescribed medications, billions of dollars are at stake. In this case, it is not reviewers or journal editors who are impeding publication of negative findings. Rather it is the companies themselves that decide to withold negative data from publication. [...]
  
  Most studies showing negative results remain unpublished, and short of making official enquiries to government agencies, their data are unavailable to researchers, doctors and the public at large." Source: The Emperor's New Drugs, p. 39
• "The fact that what gets published are the trials with positive results was most convincingly shown by a group of researchers at the Oregon Health and Science University, who followed up on our initial analysis of the FDA data by comparing the conclusions reached by the FDA with those reported by the drug companies in journal articles. Of 38 drug-company clinical trials that the FDA viewed as having positive results, all but one was published. In the same documents, the FDA described 36 trials as having negative or questionable results. Most of these negative trials were not published at all, and of the few that were published, most were described in the journal articles as showing positive results -- despite the fact that the FDA had concluded that they had not." Source: The Emperor's New Drugs, p. 67, describing the journal articleSelective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy
• "In 2008 a group of researchers decided to check for publication of every trial that had ever been reported to the US Food and Drug Administration for all the antidepressants that came onto the market between 1987 and 2004. This was no small task. The FDA archives contain a reasonable amount of information on all the trials that were submitted to the regulator in order to get a license for a new drug. But that's not all the trials, by any means, because those conducted after the drug has come onto the market will not appear there; and the information that is provided by the FDA is hard to search, and often scanty. But it's an important subset of trials, and [...] it's also a representative slice of trials from all the major drug companies.
  
  The researchers found seventy-four studies in total, representing 12,500 patients' worth of data. Thirty-eight of these trials had positive results, and found that the new drug worked; thirty-six were negative. The results were therefore an even split between success and failure for the drugs, in reality. Then the researchers set about looking for these trials int he published academic literature, the material available to doctors and patients. This provided a very different picture. Thirty-seven of the positive trials—all but one—were publihsed in full, often with much fanfare. But the trials with negative results had a very different fate: only three were published. Twenty-two were simply lost to history, never appearing anywhere other than in those dusty, disorganised, thin FDA files. The remaining eleven which had negative results in the FDA summaries did appear in the academic literature, but were written up as if the drug was a success. [...]
  
  This was a remarkable piece of work, spread over twelve drugs from all the major manufacturers, with no stand-out bad guy. It very clearly exposed a broken system: in reality we have thirty-eight positive trials and thirty-seven negative ones; in the academic literature we have fourty-eight positive trials and three negative ones. Take a moent to flip back and forth between those in your mind: 'thirty-eight positive trials, thirty-seven negative'; or 'forty-eight positive trials and only three negative.'" Source: Bad Pharma, p. 19
• One study of large randomized clinical trials that were registered on clinicaltrials.gov found that 29% went unpublished. Source: Non-publication of large randomized clinical trials: cross sectional analysis
• "Whereas many of the negative trials were not published at all, some of the positive trias were published many times, a practice known as 'salami slicing', and this was often done in ways that would make it difficult for reviewers to know that the studies were based on the same data. In some cases, the authors were different, and references to previous publication of the data were often missing. Sometimes there were minor differences in the data between one publication and another, as well as between the data as presented to regulatory agencies and the data as published. So a reviewer trying to summarize the data would be likely to count the positive data more than once.
  
  Another trick was to publish only some of the data from a clinical trial, a manoeuvre that researchers call cherry-picking the data. Some clinical trials are conducted in more than one location. These are called multi-centre studies. Multi-centre studies make it easier to find sufficient patients to conduct the trial. They also make it easier to cherry-pick the data. For example, one multi-centre study of Prozac was presented to the FDA as showing a drug-placebo difference of three points on the Hamilton scale. When the data from this clinical trial was published, the difference was reported as 15 points -- a five-times increase in effectiveness. How was this magical augmentation of the benefits of Prozac accomplished? The full study was conducted on 245 patients. The published paper reported data from only 27 of these patients. In the published version, the data from the bulk of the patients were left out, making the drug seem much more effective than it really was." Source: The Emperor's New Drugs, p. 41
• "Drug companies also publish 'pooled analyses' of the trials they have conducted. That is, they bundle together the results of different trials and analyse the drug-placebo difference across them. This is similar to the meta-analyses my colleagues and I have conducted, but with one important difference. Our meta-analyses, in common with most others reported in the scientific literature, are based on all the studies that we were able to find. In contrast, the drug companies pick and choose which studies they wish to include in their pooled analyses. For example, GlaxoSmithKline submitted 15 clinical trials of Seroxat to Swedish regulators. In addition to being published individualy -- sometimes more than once -- studies with positive results were also included in six different pooled analyses. Most of the studies with negative results were, of course, not included in the pooled analyses.
  
  There is yet another way in which pooled analyses can hide negative data. Rather than not publishing the negative data at all, the companies can bundle them together with data from positive trials, so that the overall result is positive. By so doing, they can truthfully claim that they have published the data from a negative trial, while hiding the fact that those data showed no difference between a drug and placebo. The article by the Swedish regulators showed that the data from about 20 per cent of trials were not published at all. The data from another 20 per cent of trials were bundled together with data from more successful trials, so that their negative results were hidden from view. Taken together, approximately 40 per cent of the data are kept out of sight. Practices like this [...] make it exceptionally difficult for reiewers to establish how effective the drugs really are." Source: The Emperor's New Drugs, p. 42
• "A huge amount of research gets presented at conferences, but our current best estimate is that only about half of it ever appears in the academic literature. Studies presented only at conferences are almost impossible to find, or cite, and are especially hard to access, because so little information is available on the specific methods used in the research (often as little as a paragraph)." Source: Bad Pharma, p. 25, citing Full publication of results initially presented in abstracts.
• "The most current systematic review on publication bias, from 2010, [...] draws together the evidence from various fields. Twelve comparable studies follow up conference presentations, and taken together they find that a study with a significant finding is 1.62 times more likely to be published. For the four studies taking lists of trials from before they started, overall, significant results were 2.4 times more likely to be published. Those are our current best estimates of the scale of the problem. They are current, and they are damning." Source: Bad Pharma, p. 27, citing Dissemination and publication of research findings: an updated review of related biases
• "In 2004 the International Committee of Medical Journal Editors (ICMJE) — a collection of editors from the most influential journals in the world - published a policy statement, announcing that none of them would publish any clinical trials after 2005, unless they had been properly registered before they began. They did this, essentially, to force the hand of the industry and researchers; if a trial has a positive result, then people desperately want to pubish it in the most prestigious journal they can find. Although they had no legal force, the journal editors did have the thing that companies and researchers wanted most: the chance of a major journal publication. By insisting on pre-registration, they were doing what they could to force researchers and industry sponsors to register all trials. Everyone rejoiced: the problem had been fixed.
  
  If you think it seems odd — and perhaps unrealistics — that fixing this crucial flaw in the information architecture of a $600 billion dollar industry should be left to an informal gathering of a few academic editors, with no legislative power, then you'd be right. Although everybody began to talk as if publication bias was a thing of the past, in reality it was continuing just as before, because the journal editors simply ignored their own threats and promises. [...]
  
  In 2008 a group of researchers went through every single trial in the top ten medical journals, every one of which was a member of the ICMJE, after the deadline for pre-registration. Out of the 323 trials published during 2008 in these high-impact academic journals, only half were adequately registered (before the trial, with the main outcome measure properly specified), and trial registration was entirely lacking for over a quarter. The ICMJE editors had simply failed to keep their word." Source: Bad Pharma, p. 51, citing Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors, Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials
• "In 2007 the FDA Amendment Act was passed. This is much tighter: it requires registration of all trials of any drug or device, at any stage of development other than 'first-in-man' tests, if they have any site in the US, or involve any kind of application to bring a new drug onto the market. It also imposes a startling new requirement: all results of all trials must be posted to clinicaltrials.gov, in abbreviated summary tables, within one year of completion, for an trial on any marketed drug that completes after 2007. Once again, to great fanfare, everyone believed the problem had been fixed. But it hasn't been, for two very important reasons.
  
  First, unfortunately, despite the undoubted goodwill, requiring the publication of all trials starting from 'now' does absolutely nothing for medicine today. There is no imaginable clinic, anywhere in the world, at which medicine is practiced only on the basis of trials that completed within the past three years, using only drugs that came to market since 2008. In fact, quite the opposite is true: the vast majority of drugs currently in use came to the market over the past ten, twenty, or thirty years, and one of the great challenges for the pharmaceutical industry today is to create drugs that are anything like as innovative a those that were introduced in what has come to be known as the 'golden era' of pharmaceutical research, when all the most widely used drugs, for all the most common diseases, were developed. Perhaps they were the 'low-lying fruit', plucked from the research tree, but in any case, these are the tablets we use.
  
  And crucially, it is for these drugs — the ones we actually use — that we need the evidence: from the trials completed in 2005 or 1995. These are the dugs that we are prescribing completely blind, mislead by a biased sample of trials, selectively published, with the unflattering data buried in secure underground data archives [...].
  
  But there is a second, more disturbing resaon why these regulations should be taken with a pinch of salt: they have been widely ignored. A study published in January 2012 looked at the first slice of trials subject to mandatory reporting, and found that only one in five had met its obligation to post results. Perhaps this is not surprising: the fine for non-compliance is $10,000 a day, which sounds spectacular, until you realise that it's only $3.5 million a year, which is chickenfeed for a drug bringing in $4 billion a year. And what's more, no such fine has ever been levied, throughout the entire history of the legislation." Source: Bad Pharma, p. 53, citing Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study.
• Ben Goldacre explains why it is largely the fault of researchers, and not journals, that negative results go unpublished: "One survey simply asked the authors of unpublished work if they had ever submitted it for publication. One hundred and twenty-four unpublihsed results were identified, by following up on every study approved by a group of US ethics committees, and when the researchers contacted the teams behind the unpublished results, it turned out that only six papers had ever been submitted. Perhaps, you might say, this was a freak finding. Another approach is to follow up on all the papers submitted to one journal, and to see if those with negative results are rejected more often. Here again, the journals seem blameless: 745 manuscripts submitted to the Journal of the American Medical Association (JAMA) were followed up, and there was no difference in acceptance rate for significant and non-significant findings. The same thing has been tried with papers submitted to the BMJ, the Lancet, Annals of Internal Medicine and the Journal of Bone and Joint Surgery. Again and again, no effect was found. Might that be because the journals played fair when they knew they were being watched? Turning around an entire publishing operation for one brief performance would be tough, but it's possible. [...] Journals may not be entirely innocent, but it would be wrong to lay the blame at their door. [...]
  
  In recent years, the era of open-access academic journals has got going in ernest: there are now several, such as Trials, which are free to access, and have a core editorial policy that they will accept any trial report, regardless of result, and will actively solicit negative findings. With offers like this on the table, it is very hard to believe that anyone would really struggle to publish a trial with a negative result if they wanted to. And yet, despite this, negative results continue to go missing, with vast multinational companies simply withholding results on their drugs, even though academics and doctors are desperate to see them." Source: Bad Pharma, p. 36, citing Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards., Publication bias in editorial decision making., Predictors of publication: characteristics of submitted manuscripts associated with acceptance at major biomedical journals
• "The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children found the drugs were no better than sugar pills, according to documents and testimony released at a congressional hearing yesterday.
  
  Regulators suppressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies in drug labels, and in one case the agency reversed a manufacturer's decision to amend its drug label to say that the drug was associated in studies with increased hostility and suicidal thinking among children." Source: FDA Urged Withholding Data on Antidepressants
  • "How can we explain such strange behaviour on the part of regulatory agencies? Perhaps part of the answer lies in the way they are funded. Once upon a time, the FDA was funded solely by the government. But that changed in 1992, when Bush senior signed a bill into law allowing the FDA to charge the drug companies fees to evaluate their new products, so that they could be approved more quickly. One of the stipulations of that bill was that none of the funds could be used by the FDA to monitor the safety of the medications it approved. That was relaxed to some extent when the law was reauthorized, first under Bill Clinton in 1997 and again under George W. Bush in 2007, but it is still the case that only a small percentage of the fees can be used for safety monitoring." Source: The Emperor's New Drugs, p. 42
• "People participate in trials believing that the results of that research will help to improve the treatment of patients like them in the future. This isn't just speculation: one of the few studies to ask patients why they have participated in a trial found that 90 per cent believed they were making a 'major' or 'moderate' contribution to society, and 84 percent felt proud that they were making this contribution. Patients are not stupid or naive to believe this, because it is what they are told on the conest forms they sign before participating in trials. But they are mistaken, because of the results of trials are frequently left unpublished, and withheld from doctors and patients. These signs conest forms therefore mislead people on two vitally important points. First, they fail to tell the truth: that the person conducting the trial, or the person paying for it, may decide not to publish the results, depending on how they look at the end of the study. And worse than that, they also explicitly state a falsehood: researchers tell patients that they are participating in order to create knowledge that will be used to improve treatment in the future, even though the researchers know that in many cases, those results will never be published.
  
  There is only one conclusion that we can draw from this: consent forms routinely lie to patients participating in trials. This is an extraordinary state of affais, made all the more extraordinary by the huge amounts of red tape that everyone involved in a trial must negotiate, closely monitoring endless arcane pieces of paperwork, and ensuring that patients are fully informed on the minutiae of their treatment. Despite all this regulatory theatre, [...] we allow these forms to tell patients outright lies about the control of data, and we fail to police one of the most important ethical problems in the whole of medicine. The deceit of this conest forms is, to me, a good illustrate of how broken and outdated the regulatory frameworks of medicine have become. But it also, finally, poses a serious problem for the future of research.
  
  We desperately need patients to continue to believe that they are contributing to society, because trial recruitment is in crisis, and it is increasingly hard to persuade patients to participate at all. In one recent study, a third of all trials failed to reach their original recruitment target, and more than half had to be awarded an extension. If word gets out that trials are often more promotional than genuinely scientific, recruitment will become even more difficult. The answer is not to hide this problem, but rather to fix it." Source: Bad Pharma, p. 43

Control Over Research

• "Prior to 1970, medical researchers had relatively little problem obtaining funding from the National Institutes of Health, and few medical studies were sponsored solely by drug companies. An article published in the journal Science in 1982 describes medical scientists thumbing 'their academic noses at industrial money' in the 1970s. But as government support for medical research started to decline, scientists and universities were forced to look for alternative sources of support for their research. The medical industry was more than willing to step in and lend a helping hand. Universities had no choice, and researchers' attitudes about commercial funding changed. Government funding continued to decline so that by 1990 almost two-thirds of requests for research funds were not granted. Meanwhile, between 1977 and 1990, drug company expenditures on research and development increased sixfold, and much of the money went to support university-based clinical research.
  
  This shift in the source of funding set the stage for what was to follow. In 1991, four out of five commercially sponsored clinical drug trials were still being conducted by universities and academic medical centers. Academic researchers still played key roles in all phases of the research, from designing studies to recruiting patients to analyzing data to writing the articles and submitting them for publication. This may have been good for medical science and good for universities, but it was certainly not optimal for the drug and medical-device companies. Research done in university medical centers cost more and involved more administrative hoops and delays. Most important, the checks and balances present in an academic environment could be sidestepped if the research dollars were taken elsewhere." Source: Overdosed America, p. 94
• "As drug and biotech industries assumed an ever-larger role in funding clinical trials (reaching 80 percent by 2002), they increasingly exercised the power of their purse. Control over clinical research changed -- quietly at first, but very quickly, and with profound effects on medical practice. The role of academic medical centers in clinical research diminished precipitously during the 1990s as the drug industry turned increasingly to new independent, for-profit medical research companies that emerged in response to commercial funding opportunities. These companies could gain access to patients for clinical research through community-based doctors, or play a larger role in research design, data analysis, and even writing up the findings and submitting complete articles to journals for publication. By 2000, only one-third of clinical trials were being done in universities and academic medical centers, and the rest were being done by for-profit research companies that were paid directly by the drug companies." Source: Overdosed America, p. 95
• "Clinical research organizations are a very new phenomenon. Thirty years ago, hardly any existed: now there are hundreds, with a global revenue of $20 billion in 2010, representing about a third of all pharma R&D spending. They conduct the majority of clinical trials research on behalf of industry, and in 2008 CROs ran more than 9,000 trials, with over two million participants, in 115 countries around the world." Source: Bad Pharma, p. 111, citing Association of Clinical Research Organizations
• "Increased reliance on private research companies allowed the drug industry to kill two birds with one stone: It could now call the shots on most of the studies that were evaluating its own products without having to accept input from academics who were grounded in traditional standards of medical science. And the increasing competition for commercial research dollars put academic centers under even more pressure to accept the terms offered by the commercial sponsors of research, threatening the independence and scientific integrity that had been the hallmark of the academic environment. In 1999 Dr. Drummond Rennie, deputy editor of the Journal of the American Medical Association, characterized the response of academic institutions to this changing climate: 'They are seduced by industry funding, and frightened that if they don't go along with these gag orders, the money will go to less rigorous institutions. It's a race to the ethical bottom.'" Source: Overdosed America, p. 95
• "In September 2001 an unprecedented alarm was sounded. The editors of 12 of the world's most influential medical journals, including the Journal of the American Medical Association, the New England Journal of Medicine, The Lancet, and the Annals of Internal Medicine, issued an extraordinary joint statement in their publications. In words that should have shaken the medical profession to its core, the statement told of 'draconian' terms being imposed on medical researchers by corporate sponsors. And it warned that the 'precious objectivity' of the clinical studies that were being published in their journals was being threatened by the transformation of clinical research into commercial activity.
  
  The editors said that the use of commercially sponsored clinical trials 'primarily for marketing ... makes a mockery of clinical investigation and is a misuse of a powerful tool.' Medical scientists working on corporate-sponsored research, the editors warned, 'may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation.'" Source: Overdosed America, p. 96
• "Often the medical researchers who carry out company-sponsored studies are not even allowed to see all of the data from the studies they are working on. These researchers are left in the position of analyzing and including in their articles only the data that the drug or device manufacturers have allowed them to see. In May 2000, Dr. Thomas Bodenheimer brought many of these issues to light in an important article in the New England Journal of Medicine titled 'Uneasy Alliance: Clinical Investigators and the Pharmaceutical Industry.' One researcher quoted in the article explained that controlling access to the data allows the drug companies to 'provide the spin on the data that favors them.'
  
  The September 2001 joint statement issued by the editors of major medical journals weighed in heavily on this important issue: 'we strongly oppose contractual agreements that deny investigators the right to examine the data independently.... Such arrangements not only erode the fabric of intellectual inquiry that has fostered so much high-quality clinical research, but also make medical journals party to potential misrepresentation.' Practicing doctors count on the articles in medical journals to present and interpret the complete data, thus proiding the 'scientific evidence' that they trust to guide their patient care decisions. If even the researchers who write the articles have access to only the data that the corporate sponsors allow them to see, how can anyone have confidence in the 'scientific evidence' published in the medical journals? And how can anyone have confidence in the medical care that is based upon results that have been censored to serve commercial interests?" Source: Overdosed America, p. 105
• "Before any medical article is accepted for publication in a respectable journal, it is peer-reviewed. Independent experts are called upon to evaluate the study's data, and to concur (or not) with the authors' analyses and conclusions. Most doctors believe that this peer review process guarantees the integrity and completeness of the scientific evidence presented. But the peer reviewers see only the data that have been included in the article -- not all the data the authors had access to and certainly not all the data from the study. Readers of medical journals cannot assume that the process of peer review ensures fair and impartial presentation of research results.'" Source: Overdosed America, p. 106
• "Yet another way that drug companies can make sure that results are written to best represent their interests is to hire ghostwriters to write the original draft of the article after a clinical trial is completed. As described by Melody Petersen in the New York Times, the ghostwriter submits his or her draft to the drug company, which then passes it along for final approval to the authors of record -- often busy doctors who are happy not to labor over the first draft. The problem with this system is that the drug companies get to infuse their perspective into the results from the very beginning. Dr. Linda Logdberg, a former medical ghostwriter, explained that the drug companies 'will drop a doctor if they don't think he will be particularly malleable.' The New York Times article says, 'The result ... is marketing masquerading as science.' According to a study published in JAMA, 11 percent of the articles published in peer-reviewed medical journals are written by 'ghost authors.' (And 19 percent of the articles named 'honorary authors' who had not contributed enough to the research and writing to justify being listed as authors.)" Source: Overdosed America, p. 107. Citing Madison Ave. Has Growing Role in the Business of Drug Research, and Prevalence of Articles with Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals
• "One study from 2011 took a representative sample of all the papers in six leading medical journals — include the Lancet, JAMA, and so on — then contact all 896 corresponding authors (the 'lead' author on the paper, whose contact details are always published). They included every kind of publication, from original research to review articles and editorial opinion pieces. Reviews and editorials are particularly important for the companies that employ ghostwriters, because they represent an opportunity to summarise the evidence for a whole field, in a readable format, and so set the frame for subsequent discussion and research. Knowing that the response rate was likely to be low, the researchers made a point of promising in their initial contact email that all responses would be treated with the utmost confidentiality. Remarkably they managed to get replies from over two thirds of the people they contacted. The information they received indicated that 8 per cent of all articles had ghost authorship: 12 per cent of research articles, 6 per cent of reviews, and 5 per cent of editorials.
  
  There is every resaon to believe that this is an underestimate. If a stranger contacted you out of the blue, and asked you to admit career-torpedoing antisocial and unethical behaviour from your work email address, you might be a little reluctant. A guarantee of anonymity from someone you've never heard of and never met is small reassurance against the real and forseeable consequences of confessing all. So respondents may have dishonestly denied involvement in ghostwriting. And there is every reason to believe that the 30 per cent of study authors who declined to participate at all were more likely to have been involved in ghostwriting." Source: Bad Pharma, p. 288, citing Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey
• "What do the regulations say about ghostwriting? For the most part, very little. A survey in 2010 of the top fifty medical schools in the United States found that all but thirteen had no policy at all prohibiting their academics from putting their name to ghostwritten articles. The International Committee of Medical Journal Editors, meanwhile, has issued guidelines on authorship, describing who should appear as a named author on a paper, in the hope that ghostwriters will have to be fully declared as a result. These are widely celebrated, and everyone now speakns of ghostwriting as if it has been fixed by the ICMJE. But in reality, as we have seen so many times before, this is a fake fix: the guidelines are hopelessly vague, and are exploited in ways that are so obvious and predictable that it takes only a paragraph to describe.
  
  The ICMJE criteria require that someone is listed as an author if they fulfil three criteria: they contributed to the conception and design of the study (or data acquisition, or analysis and interpretation); they contributed to drafting or revising the manuscript; and they had final approval on the contents of the paper. This sounds great, but because you have to fulfill all three criteria to be listed as an author, it is very easy for a drug company's commercial medical writer to do almost all the work, but still avoid being listed as an author. For example, a paper could legitimately have the name of an independent academic on it, even if they only contributed 10 percent of the design, 10 per cent of the analysis, a brief revision of the draft, and agreed to the final contents. Meanwhile, a team of commercial medical writers employed by a drug company on the same paper would not appear in the author list, anywhere at all, even though they conceived the study in its entirety, did 90 per cent of the design, 90 per cent of the analysis, 90 per cent of the data acquisition, and wrote the entire draft." Source: Bad Pharma, p. 299, citing Ghostwriting at Elite Academic Medical Centers in the United States, How Industry Uses the ICMJE Guidelines to Manipulate Authorship-And How They Should Be Revised
• "As the function of medical research in our society has been transformed from a fundamentally academic and scientific activity to a fundamentally commercial activity, the context in which the research is done has similarly changed: first in universities funded primarily by public sources, then in universities funded primarily by commercial sources, then by independent for-profit research organizations contracting directly with drug companies. And most recently, the three largest advertising agencies, Omnicom, Interpublic, and WPP, have bought or invested in the for-profit companies that perform clinical trials. These advertising agencies are now full-service operations, as an executive for one of the biggest health care marketing companies told the New York Times: 'We provide services that go from the beginning of drug development all the way to the launch of your products.'" Source: Overdosed America, p. 109
• Ben Goldacre on regulatory capture: "The fabulously named 'Union of Concerned Scientists' recently surveyed 1,000 scientists working at the FDA and found that 61 per cent said they knew of cases where 'Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions.' A fifth said that they themselves 'have been asked, for non-scientific reasons', to inappropriately exclude or alter technical information or their conclusions in an FDA scientific document.' Only 47 per cent thought the FDA 'routinely provides complete and accurate information to the public.' If you're worried about a think tank conducting a survey, the US Department of Health and Human Services had conducted a similar one two years earlier: again, a fifth of those surveyed said they had been pressured to approve a drug despite reservations about efficacy and safety." Source: Bad Pharma, p. 127, citing Survey of FDA Scientists Shows They Feel Pressure to Exclude or Alter Findings Fear Retaliation for Voicing Safety Concerns, Survey: FDA scientists question safety
  • See also: Pharmaceutical firms paid to attend meetings of panel that advises FDA

Drug Company Funding & Research Outcomes

• "Studies repeatedly document bias in commercially sponsored research, but the medical journals seem powerless to control the scientific integrity of their own pages. In 2003, separate studies were published in JAMA and the British Medical Journal showing that the odds are 3.6 to 4 times greater that commercially sponsored studies will favor the sponsor's products than studies without commercial funding. And in August of 2003 a study published in JAMA found that among the highest-quality clinical trials, the odds that those with commercial sponsorship will recommend the new drug are 5.3 times greater than for studies funded by non-profit organizations. The authors noted that the lopsided results of commercially sponsored research may be 'due to biased interpretation of trial results.' They cautioned that readers should 'carefully evaluate whether conclusions in randomized trials are supported by data.' In other words, doctors are warned that even the best research published in the best journals cannot be taken at face value." Source: Overdosed America, p. 97. Citing Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A systematic Review, Pharmaceutical Industry Sponsorship and Research Outcome and Quality: A Systematic Review, Association of Funding and Conclusions in Randomized Drug Trials
• A new systematic review of the literature between 2003 and 2006 concluded that, "Given their widely varying methodologies, a meta-analysis of the [...] results would be misleading. However, by way of summary, 17 analyses published since 2003 have shown an association, typically a strong one, between industry support and published pro-industry results, and 2 have not. Taken in conjunction with the earlier systematic reviews that found 20 of 23 reports of positive associations, it is unequivocally the case that sponsorship influences published results." Source: Pharmaceutical company funding and its consequences: A qualitative systematic review
• "Even when conflicts [of interest] are clearly declared, it may only be on the academic papers, and not in the subsequent work derived from it, such as guidelines or review papers. One study from 2011 took a representative sample of meta-analyses — systematic summaries of all the trials in a field — and looked to see if they described the conflicts of interest of the individual trials they summarized. Of twenty-nine meta-analyses reviewed, only two reported the funders of the trials they included. This is clear evidence that the problem is not paid forward, and that meta-analyses — widely read and influential documents — simply gloss over this important issue." Source: Bad Pharma, p. 330, citing Reporting of conflicts of interest in meta-analyses of trials of pharmacological treatments.
• Further reading:
• Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others.

FDA Conflicts of Interest

• "Since the lion's share [of FDA user fees] can only go to expedite approvals, that area of the agency has grown while staffing and resources in other parts of the FDA have been relatively starved. As drugs enter the market faster, it becomes increasingly difficult for the FDA to perform its other functions -- including monitoring drug safety, ensuring manufacturing standards, and regulating marketing. [...]
  
  Furthermore, the FDA is subject to industry pressures through its eighteen standing advisory committes, which consist of outside experts in various specialties, are charged with reviewing new drug applications and making recommendations to the agency about approval. The FDA almost always takes their advice. Many members of these committees have financial connections to interested companies. Although there are conflict of interest rules that prohibit participation in such cases, the agency regularly waives them on the unlikely grounds that someone's advice is indispensable. USA Today examined FDA hearing records in 2000 and found that 'at 92 percent of the meetings at least one member had a financial conflict of interest,' and 'at 55 percent of meetings, half or more of the FDA advisers had conflicts of interest.'
  
  Members of FDA advisory committees are said to command unusually high consulting fees from drug companies. They are certainly in a position to do so. They probably don't even have to say, 'Pay me if you want your drugs approved.' According to the Washington Times reporter August Gribbin, 'One drug company executive who asked not to be identified referred to the advisory committee members' approaches for obtaining [consulting] work as 'shakedowns' because a company that refused to yield to such requests could doom products that cost tens of millions of dollars to develop.'" Source: The Truth About Drug Companies, p. 209
• "Funding by drug companies may have seemed like a good idea for the cash-strapped FDA, but what about protecting the consumer from the drug companies' influence? How unbiased can CDER be when half its budget comes from the drug companies themselves? An anonymous survey done by Public Citizen in 1998 reveleade that FDA review officers felt that standards had declined as pressure to approve new drugs increase. The FDA medical officers who responded to the survey identified 27 new drugs that had been approved within the previous three years that they felt should not have been. A similar report on CDER by the inspector general of the U.S. Department of Health and Human Services, published in March 2003, found that 58 percent of the medical officers said that the six months allotted for reiew of priority drugs is not adequate, and that one-third of respondents did not feel comfortable expressing their differing opinions. In the FDA's own Consumer Magazine, Dr. Janet Woodcock, director of CDER since 1994, wrote that tight deadlines for drug approval were creating 'a sweatshop environment that's causing high staffing turnover.'
  
  The most dangerous consequence of these changes were that the number of drugs approved by the FDA but later withdrawn from the market for safety reasons increased from 1.6 percent of drugs approved between 1993 and 1996 to 5.3 percent between 1997 and 2000. [...] All told, 22 million Americans, one out of every ten adults, had taken a drug that was later withdrawn from the market between 1997 and 2000." Source: Overdosed America, p. 86

Lobbying

• "The pharmaceutical industry has by far the largest lobby in Washington -- and that's saying something. In 2002 it employed 675 lobbyists (more than one for each member of Congress) -- many drawn from 138 Washington lobbying firms -- at a cost of over $91 million. The job of these lobbyists is to prowl the corridors of power in Washington to promote drug company interests. The industry's trade association, PhRMA, also maintains its offices in Washington, where it had a full-time staff of 120 in 2002, and accounted for $14 million of the lobbying expenditures and 112 of the lobbyists. According to the consumer advocacy group Public Citizen, from 1997 through 2002, the industry spent nearly $478 on lobbying.
  
  Drug company lobbyists are extremely well connected. In 2002, they included 26 former members of Congress, and another 342 who had been on congressional staffs or otherwise connected with government officials. Twenty had been congressional chiefs of staff. [...] Some lobbyists were actually related to members of congress [...]. Even without the political contributions [...], this revolving door between government and lobbyists guarantees that the industry will have attentive and sympathetic ears in Washington." Source: The Truth About Drug Companies, p. 198
• See also: Legislating Under the Influence: How The Health Care Industry Spends Millions On Campaign Contributions and Lobbying To Influence Key Lawmakers in Health Care Reform Fight of 2009

Off-label Prescriptions

• "One of the least-known but biggest gifts Congress gave big pharma was to authorize an industry-supported private company to decide whether Medicaid would pay for off-label uses of prescription drugs. While drug companies are not permitted to market drugs for uses not approved by the FDA, doctors may prescribe drugs for whatever reason they like. That leaves open the question of whether insurers will pay -- not a small matter, since as many as half of all prescriptions are written for off-label uses. The question is particularly important for Medicaid, which is the largest government program that pays for outpatient drugs. In 1997, Congress named Drugdex Information Service as one of three organizations that would decide which off-label uses Medicaid would cover. Drugdex lists drugs and their uses in a large directory, which it sells to pharmacists and anyone else who can afford the $3823 annual subscription cost. If a use is listed there, Medicaid must pay for the drug when it is prescribed for that use.
  
  Drugdex is owned by the Thomson Corporation, a multibillion-dollar firm that includes medical education and communication companies (MECCs) among its many other divisions. This creates an incestuous relationship whereby Thomson gains from putting on continuing medical education courses for drug companies, while drug companies gain from having their drugs listed in Thomson's Drugdex. Furthermore, the MECCs 'educate' doctors about off-label uses of drugs. With such close connections to industry, it's not surprising that Drugdex authorizes about twice as many off-label uses as the other two federally recognized directories, both of which are nonprofit. In 2003, according to The Wall Street Journal, Drugdex listed 203 offlabel uses for the dozen top-selling drugs in the United States. They included, for instance, 48 off-laber uses for Neurontin, the epilepsy drug. According to the company, Neurontin can be used for hiccups, nicotine withdrawal, migraine, and just about anything else you care to name, and Medicaid has to pay for it.
  
  Because Drugdex lists so many more off-label uses than the other directors, it in effect sets the standards. It cites articles to support its listings, but the articles are not required to meet any scientific criteria. [...] Since this arrangement bypasses FDA approval, it seems to make the agency's scientific scrutiny almost irrelevant. Whatever the industry can get Drugdex to put in the directory as apparently okay." Source: The Truth About Drug Companies, p. 204
• "Off-label use of medications is very common. Up to 20% of all drugs are prescribed off-label and among some classes of cardiac drugs, off-label use can be as high as 46%." Source: AMA: On-label and off-label usage of prescription medicines and devices, and the relationship to CME, citing Off-label prescribing among office-based physicians.
• "Many FDA approved drugs usually are not tested for safety and efficacy specifically in children. Therefore, it is believed that 50-75% of all medications prescribed by pediatricians in the U.S. are for off-label applications." Source: AMA: On-label and off-label usage of prescription medicines and devices, and the relationship to CME, citing Pediatric drug labeling: improving the safety and efficacy of pediatric therapies.

Clinical Guidelines

• "Recognizing that no doctor can keep up with the deluge of medical research about all of the different clinical conditions, the medical profession regularly develops clinical practice guidelines to establish the standards that define good medical care. These guidelines are created by panels of nationally recognized clinical experts, and are usually sponsored by nonprofit organizations (such as the American Heart Association, the National Osteoporosis Foundation, or the National Stroke Association), professional societies (such as the American Colleges of Gastroenterology, Pschiatry, or Rheumatology), or governmental agencies.
  
  Clinical guidelines provide expert review of the research and allow doctors to be confident that their decisions regarding patient care reflect the best available scientific evidence. Guidelines also provide benchmarks by which the quality of a doctor's care can be evaluated, and (always lucking in the background of a doctor's thoughts) they are admissable as evidence of the accepted standards of care in medical malpractice cases." Source: Overdosed America, p. 127
• "A study published in JAMA in 1999 evaluating the quality of the guidelines showed, ironically, that they often fall short of established standards. The following year The Lancet published a report that found that only one of the 20 clinical guidelines examined met established standards of quality for three simple criteria: description of the professionals involved in formulating the guidelines; description of the sources of information used to find the relevant scientific evidence; and grading of the evidence used to support the main recommendations.
  
  In 2000, Canadian researchers from the British Columbia Office of Health Technology Assessment evaluated the quality of the guidelines that addressed the testing of cholesterol levels. They found that four out of five of these guidelines did not reflect the best scientific evidence available. The Canadian Researchers also found that 'the greater involvement of clinical experts in the development process of the clinical practice guidelines, the less of recommendations reflected the research evidence.'" Source: Overdosed America, p. 127
• "Then, in 2002, JAMA published the most damning study of all. The study found that four out of five experts who participate in the formulation of clinical practice guidelines have financial relationships with drug companies, averaging more than 10 such relationships each. A whopping 59 percent of the experts 'had relationships with companies whose drugs were considered in the guideline they authored.' This would be the equivalent of a judge's having an ongoing financial relationship with one of the litigants in a case he was hearing, or a stockbroker's recommending his uncle's IPO. More than half of the guidelines examined in the JAMA study had not even established a formal process for declaring participants' relationships with drug companies." Source: Overdosed America, p. 127
• "Beyond universities, there are other important institutions in medicine, such as membership organisations and the professional bodies, which all have their own engagements with industry. Here are some fairly random pickings from around the world. In America in 2009, the Heart Rhythm Society received $7 million, half of its revenue, from industry. The American Academy of Allergy, Asthma and Immunology 40 per cent of its income from industry. The American Academy of Pediatrics officially supports breastfeeding, but recceives about half a million dollars from Ross, manufacturers of Similac infant formula (Ross's logo even appears on the cover of the AAP's 'New Mother's Guide to Breast Feeding'). The British Journal of Midwifery runs ads from powdered-baby-milk manufacturers, and baby-milk companies run 'training days' for midwives in hospitals around the UK, which are well attended, because they are free. The American Academy of Nutrition and Dietetics is sponsored by Coca-Cola. In 2002 the American College of Cardiology thanked Pfizer for $750,000, Merck for $500,000, and so on. [...]
  
  It's a very troubling state of affairs, and this is not simply an aesthetic concern: these organisations run conferences that are internationally attended, and set ethical norms for their members. More than that, they make the guideline documents which are followed around the world, and creating these often requires subjective judgement calls, especially where the evidence is thin. One study asked 192 authors on fourty-four guidelines documents if they received money from industry, and on average four out of five said yes." Source: Bad Pharma, p. 338, citing http://www.propublica.org/documents/item/87376-heart-rhythm-society, Medical Groups Shy About Detailing Industry Financial Support, On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health, Academy of Nutrition and Dietetics: Who Are the Academy's Corporate Sponsors?, Relationships between authors of clinical practice guidelines and the pharmaceutical industry.

Marketing To Doctors

• "Prescription-tracking companies buy information from big pharmacy chains about doctors' prescribing habits and sell it to drug companies. Using these physician profiles, drug reps know exactly what a doctor prescribes before each visit, so they can tailor their sales pitch and make every minute count. If they know that a doctor is using a competitor's drug, for instance, they can spend their time undermining that drug without actually acknowledging that they know the doctor uses it. And they can tell whether the visit paid off by seeing what the doctor uses afterward. This monitoring enables drug companies to focus their attentions on the most promising doctors." Source: The Truth About Drug Companies, p. 130
• "The number of reps making sales pitches in doctors' offices has tripled over the past 10 years. There is now one full-time drug rep for every four and a half office-based doctors. In 2001, drug companies spent $4.7 billion 'detailing' ('industry speak' for drug reps' sales calls) to the 490,000 office-based doctors in the United States, or about $10,000 for each doctor per year. And that doesn't include the cost of the drug samples the reps left." Source: Overdosed America, p. 124
• "According to an article in the Journal of General Internal Medicine published in 1996, 42 percent of the material given to doctors by drug reps made claims that were in violate of FDA regulations, and only 39 percent of the material provided scientific evidence to support its marketing claims." Source: Overdosed America, p. 125
• "Once you start chatting to reps, you rapidly learn that they break doctors down into types, and these have even been documented in academic papers. If they think you're a crack, evidence-based medicine geek, they'll only come to you when they have a strong case, and won't bother promoting their weaker drugs at you. As a result, in the minds of bookish, sceptical evidence geeks, that rep will be remember as a faithful witness to strong evidence; so when their friends ask about something the rep said, they're more likely to reply, 'Well, to be fair, the reps from that company have always seemed pretty sound whenever they've brought new evidence to me...' If, on the other hand, they think you're a soft touch, then this too will be noted.
  
  One classic paper written by a drug rep in collaboration with an academic describes these techniques in detail, and if you're a doctor, I highly recommend reading it, because you might see your own discussions reflected back to you in an unexpected light. They go through various situations, and the training and methods used: how te manage the acquiescent doc who says yes to everything, just to get you out of the room? How to set boundaries on the mercenary doctor who wants more expensive dinners at restaurants like Nobu? What about the lonely GP who wants a friend? This kind of social strategic information may well appear in the notes your local drug rep keeps on you." Source: Bad Pharma, p. 277, citing Following the Script: How Drug Reps Make Friends and Influence Doctors

Medical Journals

• "According to the editor of the British Medical Journal, Dr. Richard Smith, 'The major journals try to counterbalance the might of the pharmaceutical industry, but it is an unequal battle -- not least because the journals themselves profit from publishing studies funded by the industry.'
  
  The journals benefit from the publicity gained from publishing large drug company-sponsored studies. This increases the value of their advertising and enables them to sell back to the drug companies reprints of articles, which the drug companies then distribute as marketing tools to doctors. According to Dr. Smith, this can amount to more than $1 million for a single article. At the same time that medical journals are given incentives to please the drug companies, they are also given strong disincentives to go against drug company interests. According to Dr. Marcia Angell, former editor of NEJM, editors of medical journals exercise self-censorship -- trying to avoid offending their chief advertisers, the drug companies.
  
  Dr. Robert Fletcher learned about this firsthand. In 1992, he was editor of the Annals of Internal Medicine when it published an article reporting that 44 percent of drug ads in medical journals were written in a way that would lead doctors with no other source of information to prescribe improperly. The article also reported that 92 percent of those ads were in some violation of FDA rules. Writing in The Lancet in 2003, Dr. Fletcher said that as punishment for publishing this article, the pharmaceutical industry 'withdrew many adverts' and showed that it was 'willing to flex its considerable muscles when it felt its interests were threatened.' This is a price that medical journal editors would prefer not to pay." Source: Overdosed America, p. 113
• "Advertising is not the only source of drug company revenue for academic journals; there are several other strands of income, some of which are not immediately apparent. Journals often product 'supplements', whole extra editions outside of its normal work. These are often sponsored by a drug company, based on the presentations at one of its sponsored conferences or events, and have much lower scientific standards than are found in the journal itself.
  
  Then there are 'reprints'. These are special extra copies of individual academic papers that are printed off and sold by academic journals. These are then handed out to doctors by drug reps to promote their drugs, and are bought in huge quantities, with spends of up to $1 million to buy crates of copies of just on paper. Those are the sorts of figures that haunt editors' imaginations when they try to choose which of two trials they should publish. Richard Smith, a former editor of the British Medical Journal, framed the dilemma: 'Publish a trial that will bring in $100,000 of profit, or meet the end-of-year budget by firing an editor.'" Source: Bad Pharma, p. 306, citing Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies
• "Is there any evidence to show that journals are more likely, on a fair comparison, to take industry-funded studies?
  
  This has been studied only rarely — because, as we need to keep reminding ourselves, this whole area has hardly been a research funding priority — but the answer appears to be yes. A paper published in 2009 analysed every study ever published on the influenza vaccine (although it's reasonable to assume that its results might hold for other subject areas). It looked at whether funding source affected the quality of a study, the accuracy of its summary, and the eminence of the journal in which it was published.
  
  Academics measure the eminence of a journal, rightly or wrongly, by its 'impact factor': an indicator of how commonly, on average, research papers in that journal go on to be 'cited' or 'referenced' by other research papers elsewhere. The average journal impact factor for the ninety-two government funded studies was 3.74; for the fifty-two studies wholly or partly funded by industry, the average impact factor was much higher, at 8.78. This means that studies funded by the pharmaceutical industry were hugely more likely to get into the bigger, more respected journals.
  
  That's an interesting finding, because ther is no other explanation for it. There was no difference in methodological rigour, or quality, between the government-funded research and the industry-funded research. There was no difference in the size of the samples used in the studies. And there is no difference in where people submit their articles: everyody wants to get into a big, famous journal, and everybody tries them first. If they get rejected they will try lesser and lesser journals, until someone takes the paper. It's possible that the industry-funded researchers were simply more dogged, or more shameless; and that maybe, when they were rejected by one major journal, they hawked their paper to other equally large ones. It's possible that they could do this more rapidly than those without industry funding, because they had administrative assistance from professional writers to deal with the tedious bureaucracy of each journal's submission system, and tolerated the long delay in publication that this strategy would cause. Or perhaps lucrative industry-funded studies are simply favoured by editors.
  
  Either way, getting published in a higher-impact journal is a huge advantage, for a number of reasons. First, it is prestigious, and implies that your research is regarded as higher-quality. But second, papers in bigger journals are simply more likely to be read." Source: Bad Pharma, p. 307, citing Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review

Phase IV Trials

• "Only some of the trials are to test new drugs to get FDA approval. Many are of drugs already on the market -- called 'postmarketing' or 'Phase IV' studies. Often these are to find new uses for old drugs to expand their markets. A few are required by the FDA to look for unknown side effects. And a great many -- perhaps most -- are really, in the view of many critics, just excuses to pay doctors to put patients on a company's already-approved drug. [...]
  
  The most common phase IV trials are so-called surveillance studies. Here sponsors pay doctors to put patients on drugs and answer a few simple questions about how they fared. There is no randomization and no comparison group, so it is usually impossible to draw any reliable conclusions. CenterWatch, a company that serves as a clearinghouse for information about the clinical trials industry, recently ran an article titled 'Phase IV Market Steams Ahead.' In it, the aim of surveillance studies was made clear: 'The primary purpose of this type of post-marketing research is to familiarize physicians and patients with new drugs.' And the article pointed out that such research does indeed influence doctors' drug choices and formulary recommendations." Source: The Truth About Drug Companies, p. 29, 164
• "Since the majority of Phase IV studies will never be submitted to the FDA, they may be totally unregulated. Few of them are published. In fact, like all industry-sponsored trials, they are not likely to be published at all unless they show something favorable to the sponsor's drug. If they are published, it is often in marginal journals, because the quality of the research is so poor. CenterWatch decribed Phase IV studies this way: 'Whereas companies generally prefer [phase I through III] studies to be done by experienced research investigators, phase IV programs offer sponsors the opportunity to initiate and develop strategic relationships, especially with high-volume prescribers.' In other words, it isn't really research, so don't worry too much about its scientific validity." Source: The Truth About Drug Companies, p. 166

Continuing Education

• "In most states doctors are required to receive continuing medical education (CME) throughout their professional lives to maintain their licenses. The requirements are substantial, and the education must be provided through accredited institutions. Most doctors earn the necessary credits by attending meetings and lectures -- as many as a hundred a year. [...]
  
  But who pays for these programs? You might assume doctors pay for their own postgraduate education, just as other professionals do, but you would be wrong. In 2001, drug companies paid over 60 percent of the costs of continuing medical education, and that fraction has increased since then. Formerly, they directly supported the accredited professional organizations, but now they usually contract with private medical education and communication companies (MECCs) to plan the meetings, prepare teaching materials, and procure speakers. [...] Here we have firms working for big pharma who are supposed to be providing impartial instruction about their clients' drugs. People pretend not to notice this flagrant conflict of interest. But the way [they] advertise themselves to drug companies tells the real story. One pitched its services by observing, 'Medical education is a powerful tool that can deliver your message to key audiences, and get those audiences to take action that benefits your product.' In other words, hire us, and we will get doctors to prescribe your drug. Some MECCs are even owned by large advertising agencies, making the connection between continuing medical education and drug marketing still more obvious." Source: The Truth About Drug Companies, p. 139
• "Most [doctors] insist that these financial relationships do not color their opinions, but a review article published in JAMA titled, 'Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?' shows that drug company-sponsored lectures are two-and-a-half to three times more likely to mention the sponsor's drug in a positive light and competitors' drugs in a neutral or negative light. Doctors who receive honoraria for speaking and research support from a drug company are four and nine times more likely, respectively, to support the use of that company's drug in their hospital." Source: Overdosed America, p. 123
• "In the US there are various regulations and guidelines, which have the usual holes. In 2007 the Senate Finance Committee noted, for example, that drug companies are not compelled to follow these guidelines, and that no agency every puts monitors in the audience to see what's being taught, or engages in any kind of proactive assessment of content. Even if a CME provider is reported, found out, and has its accreditation revoked, this can take nine years. [...]
  
  When ACCME revied the CME providers it accredits, it found that one in four were openly breaching its guidelines — not in clever, covert ways, but blatantly, not even bothering to hide it. These companies were fully accredited to teach doctors, and they allowed sponsors to influence decisions about content; allowed sponsors to choose who spoke; failed to check for conflicts of interest; repeatedly used the sponsor's drug's brand name to the exclusion of all others; and so on. This is hardly surprising — in fact, to imagine such transgressions wouldn't take place is absurd. In a large, competitive and expensive market, which CME company is going to get the repeat business: the one that respects the rules? Or the one that gives the drug company what it wants?
  
  Perhaps even more remarkably, doctors themselves recognize that the content of this teaching is biased. This includes — specifically — the ones who accept it. In a survey from 2011, 88 per cent of attenders of sponsored educational activities thought that commercial support introduces bias, but only 15 per cent thought such free teaching should be banned, and the majority were unwilling to pay properly for CME themselves. Reports from the American Medical Association, the Institute of Medicine, the Senate Finance Committee, the American Association of Medical Colleges and more have all called for commercial support of CME to be ended. They have all been ignored. [...] Doctors around the world [...] are taught which drugs are best by the drug companies themselves." Source: Bad Pharma, p. 318, citing Committee Staff Report to the Chairman and Ranking Member Use of Educational Grants by Pharmaceutical Manufacturers (Print 110-21), Clinician attitudes about commercial support of continuing medical education: results of a detailed survey.

Patent Extension

• "The USPTO actually has an incentive to grant patents rather than deny them, because its examiners are paid bonuses that depend in part on the number of patents they process. Since it is faster to grant a patent than to deny it and risk having the decision appealed, granting patents is what the examiners tend to do. The result is that nowadays nearly anything -- including new uses, dosage forms, and combinations of old drugs, even the coatings and colors of pills -- can be patented." Source: The Truth About Drug Companies, p. 177
• "If a brand-name company sues a generic for patent infringement, FDA approval of the generic drug will automatically be delayed for thirty months (unless the case is decided before then, which is unusual) -- whatever the merits of the suit. In effect, the FDA will add thirty more months to the brand-name drug's exclusivity. [...] Furthermore, Hatch-Waxman stipulated that the first generic company to challenge a patent in that way would have six months of exclusivity -- free from competition by other generics. That would be its reward for taking on a big drug company.
  
  Hatch-Waxman has been a bonanza for big pharma. While it was meant to stimulate competition, it has often had exactly the opposite effect. Since then, brand-name drug companies routinely file not just one patent on their blockbusters but a series of them spread throughout the life of the first one. These patents are on every conceivable feature of the drug -- never mind usefulness, novelty, or non-obviousness, or how remote from the originally approved drug and its approved use. And remember, patents are very easy to get. The result is that generic companies are routinely charged with infringement of one of these secondary patents, which immediately triggers thirty months of additional exclusivity. Companies sometimes try to slow teh process still more by filing so-called citizen petitions, in which they pretend to raise safety concerns about a generic drug. And finally, they may even pay a generic company to agree to defer entry into the market. Because of the six-month exclusivity given to the first generic company, this collusion blocks other generic companies. Through such shenanigans, exclusivity can be prolonged for years." Source: The Truth About Drug Companies, p. 181
• "That sort of gaming the system is not supposed to be possible. Under the law, only challenges to patents listed in the FDA's Orange Book are supposed to trigger the thirty-month delay. To be listed in the Orange Book, patents are supposed to apply only to the drug itself, its formulation, and the use or uses for which it was approved. In other words, they are supposed to be directly relevant. Other patents related to the drug -- like those for unapproved uses or for manufacturing processes -- are not supposed to be listed. But the FDA does not even attempt to hold drug companies to that restriction. The companies list any patents they choose. [...] Sometimes, companies list virtually the same patent twice. Furthermore, the patents may be listed at any time, even years after original approval. That means there can nearly always be a frivolous patent in effect that can be used as an excluse for suing generic companies, thus triggering the thirty-month additional exclusivity. By filing new patents after the first lawsuit, then suing for infringement of those, drug companies can even obtain successive thirty-month stays." Source: The Truth About Drug Companies, p. 181
• "The Food and Drug Administration Modernization Act of 1997 added six months of protection if drug companies test their drugs in children. One might think that drugs to be used in children should be tested in them anyway, as a condition of FDA approval. But while the agency can require such testing, it seldom does. Instead, Congress offered the industry a gigantic bribe. The result is that drug companies now test their blockbusters, including drugs to treat primarily adult diseases like high blood pressure, in children, just because the extra protection is so lucrative. Less profitable drugs might not be tested in children, even though they are far more likely to be used in them." Source: The Truth About Drug Companies, p. 182

Direct-to-consumer Advertising

• "For years the pharmaceutical industry was allowed to market its drugs only to doctors. It did this through medical journals, continuing medical education, sponsored events, sales calls, and junk mail. Then, in 1981, the drug industry proposed that the FDA allow advertising directly to consumers, arguing that the public should not be denied access to the 'knowledge' that would be provided by such marketing. Four years later, the pharmaceutical industry got its foot in the door when the FDA agreed to allow 'direct-to-consumer' (DTC) advertising. But the rules were strict, and the content of the ads was, therefore, limited: Drugs could be mentioned by name, but advertisements that discussed the treatment of specific conditions were required to include a lengthy list of side effects and contraindications (situations in which the drug should not be used). As a result, the ads were vague and unfocused, primarily brand-awareness campaigns designed to smooth the way at the doctor's office.
  
  Drug companies kept pressure on the FDA to loosen these restrictions. In 1997, the FDA changed its rules so that TV and radio ads could include the condition or conditions the drug was designed to treat without presenting all of the information previously required -- only major side effects and contraindications had to appear in the ad itself. [...]
  
  The 1997 change unleashed an unprecedented onslaught of commercials. By 1999, the average American was exposed to nine prescription drug advertisements on television every day. The number of television ads increased 40-fold between 1994 and 2000." Source: Overdosed America, p. 151
• "The explosion of drug ads in the 1990s was equisitely coordinated with the transition of large numbers of Americans to health plans that covered the cost of prescription drugs. Drug companies colud now 'help' consumers realize that they had the power to request or demand expensive new brand-name drugs from their doctors (and their greedy insurance plans) for which they had to pay only a small fraction of the real cost. This became a nearly perfect system for maximizing demand, untempered by the usual discipline of cost in a well-functioning market." Source: Overdosed America, p. 151
• "In August 2001, at a time when the FDA was without a commissioner, President George W. Bush chose an accomplished lawyer, Daniel Troy, to be the FDA's new chief counsel. Daniel Troy had extensive experience in First Amendment issues, with a particularly strong record in defending the right of commercial speech. He successfully represented the Brown & Williamson Tobacco Corporation before the Supreme Court in the company's bid to block the FDA from assuming regulatory authority over tobacco products. He was also part of a legal team that sued the FDA to allow drug companies to promote 'off-label' (non-FDA-approved) use of prescription drugs, partially bypassing the FDA's review process. In short, one of the FDA's chief adversaries became its chief counsel.
  
  Three months after Troy had assumed his new position, the Department of Health and Human Services instructed the FDA that all letters to drug companies concerning marketing violations must be reviewed by its Office of the Chief Counsel prior to being sent out. In a 2002 report, the U.S. General Accounting Office (GAO) noted that prior to this change, letters had been issued within several days of identifying a violation, but the additional legal review was taking so long, an average of 41 days and as many as 78, that 'misleading advertisements may have completed their broadcast life cycle before the FDA issued the letters.'
  
  In response to the concerns raised about increased public misinformation resulting from these delays, FDA commissioner Mark McClellan wrote a letter to Representative Henry A. Waxman (D-CA), saying that a goal of completing legal reviews of FDA notification letters within 15 days would be established. The result? A report issued by the Special Investigations Division of the U.S. House of Representatives' Committee on Government Reform -- Minority Staff in January 2004 found that the average delay had increased from 41 days in 2002 to 177 days for many of the ads in 2003." Source: Overdosed America, p. 58
• "Surveys conducted by FDA and private organizations consistently show that DTC advertisements have an impact on whether consumers request and receive a specific brand-name prescription from their physician. [...] In several of these surveys, consumers were asked whether they had seen an advertisement for a prescription drug and whether seeing the advertisement resulted in discussing the medication with their doctor and receiving the prescription. Most consumers (65 to 85 percent) remembered seeing a DTC advertisement. A subset of consumers who saw an advertisement discussed the medication with their doctor. The percentage of patients asking their physicians about a prescription for a specific drug was consistent across studies, about 30 to 35 percent of those who remembered seeing a DTC advertisement. One study estimated that the 32 percent of consumers in a 2001 survey who had discussed a DTC advertisement with their doctor translated into approximately 61.1 million consumers asking about specific medications. In the consumer surveys we examined, the percentage of consumers who, in response to a DTC advertisement, requested and received a prescription from their physician for a drug they were not currently taking was generally about 5 percent (ranging from 2 percent to 10 percent). By our estimate, this means that about 8.5 million consumers received a prescription after viewing a DTC advertisement and asking their physician for the drug in 2000." Source: 2002 GAO Report - Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations
• See also: Demand Effects of Recent Changes in Prescription Drug Promotion

Required Reading

• The Selling of Attention Deficit Disorder

Jobs

Environment

K-12 Education

Standardized Testing

• "Robert Linn of the University of Colorado, a leading psychometrician, maintains that there are many reasons why one school might get better test scores than another. NCLB, he says, assumes that if school A gets better results than school B, it must be due to differences in school quality. But school A may have students who were higher achieving in earlier years than those in the other school. Or school A might have fewer students who are English-language learners or fewer students with disabilities than school B. School A, which is presumably more successful, may have a homogenous student body, while the less successful school B may have a diverse student body with several subgroups, each of which must meet a proficiency target. Linn concludes, 'The fact that the school that has the fewer challenges makes AYP [adequate yearly progress] while the school with greater challenges fails to make AYP does not justify the conclusion that the first school is more effective than the second school. The first school might very well fail to make AYP if it had a student body that was comparable to the one in the second school.'" Source: The Death and Life of the Great American School System, p. 153
• "Given the importance of test scores, it is not surprising that teachers and school officials have devised various ways of gaming the testing system: that is, tricks and shortcuts to achieve the desired results, without improving education. When the purpose of testing is informational and diagnostic, there is no reason for teachers and administrators to alter the results except through improved instruction. But when the purpose of testing is accountability, then teachers and administrators understand that there are real consequences if the scores in their classroom or their school change. If scores go up, they may get a handsome bonus; if they go down, their school will be stigmatized, and they may lose their jobs. The intense pressure generated by demands for accountability leads many educators and school officials to boost the scores in ways that have nothing to do with learning." Source: The Death and Life of the Great American School System, p. 154
• "The most reprehensible form of gaming the system is plan old-fashioned cheating. There have been many news stories about a teacher or principal who was fired for correcting students' answers before handing in the tests or leaking the questions in advance to students. In some instances, the cheating is systematic, not idiosyncratic. The Dallas Morning News analyzed statewide scores in Texas on the state's high-stakes TAKS test—which determines scholols' reputations and teachers' rewards—and found evidence that tens of thousands of students cheated every year without being detected or punished. The cheating was especially pervasive on eleventh-grade tests, which students must pass to graduate. Most of the cheating uncovered by reporters was in Houston or Dallas and was more common in low-achieving schools, 'where pressure to boost scores is the highest.' Cheating was found in charter schools at almost four times the rate of traditional pulbic schools. In response to the story, Dallas school officials beefed up their school system's testing security, but Houston school officials slammed the newspaper's study as an effort 'to dismiss the real academic progress in Texas schools.'" Source: The Death and Life of the Great American School System, p. 155
• "Many ways of gaming the system are not outright illegal, yet they are usually not openly acknowledged. Most principals know that the key to getting better test scores is to restrict the admission of low-performing students, because they depress the school's test scores. As choice becomes more common in urban districts, principals of small schools and charter schools—both of which have limited enrollments—may exclude the students who are most difficult to educate. They may do it by requiring an interview with the parents and applicants, knowing that the parents of the lowest-performing students are not as likely to show up as the parents of more successful students. They may do ti by requiring that students write an essay explaining why they want to attend the school. They may ask for letters of recommendation from the students' teachers. They may exclude students with poor attendance records, since poor attendance correlates with poor academic performance. They may limit the number of students they admit who are English-language learners or in need of special education. All such requirements tend to eliminate the lowest performers. Whenever there is competition for admission, canny principals have learned how to spot the kids who will diminish their scores and how to exclude them without appearing to do so." Source: The Death and Life of the Great American School System, p. 155, referencing School Choice or Schools' Choice? Managing in an Era of Accountability
• "A lottery for admissions tends to eliminate unmotivated students from the pool of applicants because they are less likely to apply. Principals know there is a wide range of ability within every racial and ethnic group, as well as among low-income students. A school can carefully weed out the lowest-performing students and still be able to boast that most or all of its students are African American, Hispanic, and low-income. Education researchers call this skimming or cream-skimming. It is a very effective way for a school to generate high test scores regardless of the quality of its program. Schools of choice may improve their test scores by counseling disruptive students to transfer to another school or flunking low-performing students, who may then decide to leave. Not only do choice schools look better if they exclude laggards, but the traditional public schools look worse, because they must by law accept those who were not admitted to or were booted out of the choice schools." Source: The Death and Life of the Great American School System, p. 156
• "Another way a school can improve its test scores is to reduce the participation of low-performing students on the state tests. Such students may be encouraged to stay home the day of the big test or may be suspended right before testing day. Sometimes these students are inappropriately assigned to special education to remove them from a subgroup (white or African American or Hispanic or Asian) where their low score might prevent that group from making AYP. Or the principal may assign low-performing students to a special education program that is unavailable in the school, thus ensuring that the student will transfer to a different school. In California, dozens of schools reclassified students by their race or English fluency or disability status, moving them from one category to another to improve their school's standing under NCLB (if schools have too few students in a specific subgroup, that group's scores are not reported.)" Source: The Death and Life of the Great American School System, p. 156
• "States can cleverly game the system to meet their testing targets by making the test content less challenging or by lowering the cut score (the passing mark) on state tests. State education officials tend to ignore critics who say the test is easier than previous tests, and outsiders seldom have enough information to verify their suspicions. Actually, the test may be equally difficult as in previous years, but if the state education department lowers the cut score, then more students will pass. Typically, the state releases the test scores, the press reports the results, public officials step up to take credit for any gains, and editorials congratulate the schools on their stunning progress. When the technical data are released a few weeks later, few in the media have the technical experience to ascertain whether the cut scores were lowered; even if testing experts discover that the scores were manipulated, no one pays attention. Also, states may test only a narrow range of the state's standards, so the test becomes predictable from year to year. All such tactics may produce a steady, even dramatic, increase in scores without improving any student's education." Source: The Death and Life of the Great American School System, p. 156
• "Yet another way to raise the proportion of students who reach 'proficiency' is to expand the pool of test takers who are eligible for accomodations, that is, extra time or a dictionary or other special assistance. School officials may increase the number of students who are classified as disabled so they will get extra accomodations. Or state officials may decide that students who were formerly classified as English-language learners should continue to receive extra accomodations even after they passed an English examination and achieved proficiency in English." Source: The Death and Life of the Great American School System, p. 157
• "Districts, too, have incentives to game the system. In 2007, Cleveland celebrated improved test scores, but an investigation by the Cleveland Plain Dealer determined that the district, as well as the others in Ohio, had 'scrubbed' or tossed out the test scores of students who were not continuously enrolled during the school year. Not surprisingly, most of the scores that were scrubbed were from low performers. The newspaper's analysis found that 'from 14 percent to 32 percent of scores in grades 4 to 10 were eliminated in 2007'". Source: The Death and Life of the Great American School System, p. 157
• "In the NCLB era, many states and districts have reported outsized test score gains, but the gains were usually not real. The state education department in New York quietly changed the scoring of the tests in mathematics and English language arts, which produced dramatic gains in the proportion who met state standards each year. Between 2006, when the state introduced a new test, and 2009, the proportion of students in grades three through eight who reached proficiency on the state math test leapt from 28.6 percent to an incredible 63.6 percent in Buffalo, from 30.1 percent to 58.2 percent in Syracuse, and from 57 percent to 81.8 percent in New York City. In the state as a whole, the proportion of students who were proficient jumped in these three years from 65.8 percent to 86.5 percent. To an unknowing public, these breathtaking increases were solid evidence that the schools were getting better and that more students were meeting high standards. But in reality, state officials made it easier to pass the tests. In 2006, a student in seventh grade was required to get 59.6 percent of the points on the test to meet state standards in mathematics; by 2009, a student in that grade needed only 44 percent to be considered proficient. Most people would consider a score of 44 percent to be a failing grade, not evidence of proficiency.
  
  A similar phenomenon affected New York's Regents examinations, on which students must score 65 to receive a high school diploma. Man ystudents would have failed to reach this high bar, but state officials took care of their difficulty by adjusting the cut scores. The public probably assumed that a student who received 65 had correctly answered 65 percent of the questions. But in algebra, a student would receive a passing score of 65 if he earned only 34.5 percent of possible points. To win a 65 on the biology Regents, the student needed to earn only 46 percent of the possible points. With this intricate conversion formula, the Regents diploma was turned into a goal that almost every student could reach. By making it easier to pass the Regents exam, state officials helped increase the graduation rate.
  
  In 2009, the Civic Committee of the Commercial Club of Chicago released a study demonstrating that the city's claims of dramatic test score gains were exaggerated. Chicago school officials had boasted that from 2004 to 2008, the proportion of eighth-grade students who met state standards in reading had increased from 55 percent to 76 percent, and in mathematics it had grown from 33 percent to 70 percent (President Obama recited these statistics when he announced the appointment of Arne Duncan, Chicago's superintendent of schools, as U.S. secretary of education). The study concluded, however, that 'these huge increases reflect changes in the tests and testing procedures—not real student improvement.' In 2006 the state hired a new testing company, which introduced a new test and lowered the cut scores (mainly in eighth-grade mathematics), thus producing the illusion of remarkable gains. At the same time that Chicago's scores soared on the state tests, its scores on NAEP (from 2003 to 2007) were flat. Meanwhile, student performance levels in high school remained disasterously low from 2001 to 2008, suggesting that any modest improvements in elementary grades disappeared by high school." Source: The Death and Life of the Great American School System, p. 157
• "Of all the ways of gaming the system, the most common is test preparation. Most districts, especially urban districts where performance is lowest, relentlessly engage in test-prep activities. Some preparation for test-taking is valuable; reading and studying, learning new vocabulary, and solving math problems are good ways to get ready for tests. But school districts have invested hundreds of millions of dollars in programs and teaching materials that teach students the specific types of questions that will appear on the state tests. For weeks or even months before the state test, children are drilled daily in test-taking skills and on questions mirroring those that are likely to appear on the state test.
  
  The consequence of all this practice is that students may be able to pass the state test, yet unable to pass a test of precisely the same subject for which they did not practice. They mast test-taking methods, but not the subject itself. In the new world of accountability, students' acquisition of the skills and knowledge they need for further education and for the workplace is secondary. What matters most is for the school, the district, and the state to be able to say that more students have reading 'proficiency.' This sort of fraud ignores the students' interests while promoting the interests of adults who take credit for nonexistent improvements." Source: The Death and Life of the Great American School System, p. 159
• "Of all the ways of gaming the system, the most common is test preparation. Most districts, especially urban districts where performance is lowest, relentlessly engage in test-prep activities. Some preparation for test-taking is valuable; reading and studying, learning new vocabulary, and solving math problems are good ways to get ready for tests. But school districts have invested hundreds of millions of dollars in programs and teaching materials that teach students the specific types of questions that will appear on the state tests. For weeks or even months before the state test, children are drilled daily in test-taking skills and on questions mirroring those that are likely to appear on the state test.
  
  The consequence of all this practice is that students may be able to pass the state test, yet unable to pass a test of precisely the same subject for which they did not practice. They mast test-taking methods, but not the subject itself. In the new world of accountability, students' acquisition of the skills and knowledge they need for further education and for the workplace is secondary. What matters most is for the school, the district, and the state to be able to say that more students have reading 'proficiency.' This sort of fraud ignores the students' interests while promoting the interests of adults who take credit for nonexistent improvements." Source: The Death and Life of the Great American School System, p. 159
• The National Research Council's Committee on Appropriate Test Use held that 'all students are entitled to sufficient test preparation' so they are familiar with the format of the test, the subject matter to be tested, and appropriate test-taking strategies. Surely students should know what a multiple-choice question is and should not be stumped by the nature of the testing process. (By now, there must be very few children in the United States who are unfamiliar with the nature of standardized testing and test-taking strategies.) The committee cautioned, however, that the results might be invalidated 'by teaching so narrowly to the objectives of a particular test that scores are raised without actually improving the broader set of academic skills that the test is intended to measure.'
  
  Daniel Koretz, a psychometrician at Harvard University, contends that coaching students for state tests produces test score inflation and the illusion of progress. He criticizes the common practice of teaching students certain test-taking tricks, such as how to elimate obviously wrong answers on a multiple choice question and then making a guess among the remaining choices. It is equally questionable, he says, to teach students 'to write in ways that are tailored to the specific scoring rubrics used with a particular test." When teachers focus too narowly on the test students are about to take, he writes, whatever they learn is likely to be aligned with that test and is not likely to generalize well to other tests of the same subject or to performance in real life.
  
  Koretz retested students in a district that had shown impressive gains; he found that the gains disappeared when the students took a different test of similar material, a test that had been used by the district in the recent past. Clearly the reported gains were illusory. The skills the students had learned were specific to the test and were not generalizable to unexpected situations. The scores had gone up, but the students were not better educated." Source: The Death and Life of the Great American School System, p. 159, referencing The Charter School Dust-up: Examining The Evidence On Enrollment And Achievement
• "By holding teachers accountable only for test scores in reading and mathematics, [Richard Rothstein] writes, schools pay less attention to students' health, physical education, civic knowledge, the arts, and enrichment activities. When faced with the demands to satisfy a single measure, people strive to satisfy that measure but neglect the other, perhaps more important goals of the organization.
  
  The pressure to increase test scores is likely to produce higher test scores, whether by coaching or cheating or manipulating the pool of test takers. As long as the state or district superintendent continues to report good news about student performance, the public seems satisfied, and the media usually sees no reason to investigate whether the gains are real. State and local leaders want to claim credit for improvement, rather than determine whether the improvement was meaningful.
  
  The starkest display of score inflation is the contrast between the state-reported test scores, which have been steadily (and sometimes sharply) rising since the passage of NCLB, and the scores registered by states on NAEP, the federal assessment program. NCLB permitted the states to write their own standards, pick their own tests, and decide for themselves how to define proficiency. The decision to let the states decide how well they were doing was a bow to federalism and local control, but it created a bizarre situation in which every state was left to determine what would be its passing mark and what percent of its students had reached it. Given the necessity to report gains, many states reported steady—and sometimes amazing—progress toward the mandated goal of 100 percent proficiency. Texas, for example, reported in 2007 that 85.1 percent of its students in grades four and eight were proficient readers, but on NAEP tests, only 28.6 percent were. Tennessee claimed that 90 percent of its students were proficient readers, but NAEP reported that 26.2 percent were. Similarly, Nebraska told the public that 90.5 percent of students in these grades were proficient, but NAEP said the number was 34.8 percent." Source: The Death and Life of the Great American School System, p. 161

Value-Added Assessment of Teachers - Empirical Evidence of Efficacy

• "Researchers have found that teachers' effectiveness ratings differ from class to class, from year to year, and from test to test, even when these are within the same content area. Teachers also look very different in their measured effectiveness when different statistical methods are used. Teachers' value-added scores and rankings are most unstable at the upper and lower ends of the scale, where they are most likely to be used to allocate performance pay or to dismiss teachers believed to be ineffective.
  
  Because of the range of influences on student learning, many studies have confirmed that estimates of teacher effectiveness are highly unstable. One study examining two consecutive years of data showed, for example, that across five large urban districts, among teachers who were ranked in the bottom 20% of effectiveness in the first year, fewer than a third were in that bottom group the next year, and another third moved all the way up to the top 40%. There was similar movement for teachers who were highly ranked in the first year. Among those who were ranked in the top 20% in the first year, only a third were similarly ranked a year later, while a comparable proportion had moved to the bottom 40%.
  
  Another study confirmed that big changes from one year to the next are quite likely, with year-to-year correlations of estimated teacher quality ranging from only 0.2 to 0.4. This means that only about 4% to 16% of the variation in a teacher's value-added ranking in one year can be predicted from his or her rating in the previous year.
  
  These patterns, which held true in every district and state under study, suggest that there is not a stable construct measured by value-added measures that can readily be called 'teacher effectiveness.'" Source: Problems with the use of student test scores to evaluate teachers
• "[An] economist, Jesse Rothstein, tested three methods of calculating value added by teachers and determined that none of them was reliable. He surveyed data for 99,000 North Carolina fifth graders and asked what effect their current teachers had on their scores in third and fourth grades. This was a falsification test, a deliberate attempt to ask a question whose answer should have been 'none,' since a fifth-grade teacher cannot influence students' test scores in third and fourth grades. Yet he found that all three ways of calculating value added produced large effects on fourth-grade test scores, meaning that they were flawed. The reason for these results, he speculated, was that many students are not assigned to classes randomly, but according to their prior achievement." Source: The Death and Life of the Great American School System, p. 186, citing Teaching Quality in Educational Production: Tracking, Decay, and Student Achievement
• Sean Corcoran, an NYU economist, calculated the average margins of error in the value-added percentile ranks of teachers for the model used by the New York City school system:
  
  "To get a better sense of the average level of uncertainty in the Teacher Data Reports, I examined the full set of value-added estimates reported to more than 12,700 teachers on the NYCDOE 2008-2009 reports. [...]
  
  As expected, the level of uncertainty is higher when only one year of test results are used [...] as against three years of data [...]. But in both cases, the average range of value-added estimates is very wide. For example, for all teachers of math, and using all years of available data, which provides the most precise measures possible, the average confidence interval width is about 34 points (i.e., from the 46th to 80th percentile). When looking at only one year of math results, the average width increases to 61 percentile points. That is to say, the average teacher had a range of value-added estimates that might extend from, for example, the 30th to the 91st percentile. The average level of uncertainty is higher still in ELA [English Language Arts]. For all teachers and years, the average confidence interval width is 44 points. With one year of data, this rises to 66 points." Source: Can Teachers be Evaluated by their Students' Test Scores? Should They Be? The Use of Value-Added Measures of Teacher Effectiveness in Policy and Practice, via The Death and Life of the Great American School System, p. 271.
• "In a careful modeling exercise designed to account for the various factors, a recent study by researchers at Mathematica Policy Research, commissioned and published by the Institute of Education Sciences of the U.S. Department of Education, concludes that the errors are sufficiently large to lead to the misclassification of many teachers.
  
  The Mathematica models, which apply to teachers in the upper elementary grades, are based on two standard approaches to value-added modeling, with the key elements of each calibrated with data on typical test score gains, class sizes, and the number of teachers in a typical school or district. Specifically, the authors find that if the goal is to distinguish relatively high or relatively low performing teachers from those with average performance within a district, the error rate is about 26% when three years of data are used for each teacher. This means that in a typical performance measurement system, more than one in four teachers who are in fact teachers of average quality would be misclassified as either outstanding or poor teachers, and more than one in four teachers who should be singled out for special treatment would be misclassified as teachers of average quality. If only one year of data is available, the error rate increases to 36%. To reduce it to 12% would require 10 years of data for each teacher.
  
  Despite the large magnitude of these error rates, the Mathematica researchers are careful to point out that the resulting misclassification of teachers that would emerge from value-added models is still most likely understated because their analysis focuses on imprecision error alone. The failure of policy makers to address some of the validity issues, such as those associated with the nonrandom sorting of students across schools, discussed above, would lead to even greater misclassification of teachers." Source: Problems with the use of student test scores to evaluate teachers, citing Error Rates in Measuring Teacher and School Performance Based on Student Test Score Gains
• "Economists Brian A. Jacob, Lars Lefgren, and David Sims identified another major problem with the claim that three or four or five years of great teachers in a row would wipe out the achievement gap. They said that learning gains do not all persist over time. Students forget, gains fade. After a year, only about 20 percent and at best only one-third of any gain due to teacher quality persists. After two years, unless there is continual reinforcement of learning, only one-eighth of the gain persists. The authors concluded, 'Our results indicate that contemporary teacher value-added measures may overstate the ability of teachers, even exceptional ones, to influence the ultimate level of student knowledge since they conflate variation in short-term and long-term knowledge. Given that a school's objective is to increase the latter, the importance of teacher value-added measures as currently estimated may be substantially less than the teacher value-added literature indicates.' Source: The Death and Life of the Great American School System, p. 186
  
  If these studies are right, then the gains students make each year do not remain intact and accumulate. You can't just add up the gains of one year and multiply by three, four, or five. Teachers are very important, but students don't remember and retain everything they learn."
  
  Furthermore, the estimate of only one-eighth of the gain persisting after two years is actually an upper bound. To quote the actual study, "We are [...] concerned about the possible consistency of our value-added estimates in the presence of possible non-random matching of students to teachers, [and] our estimates [...] present a useful upper bound to the true persistence of teacher effects on student achievement." Source: The Death and Life of the Great American School System, p. 186, The Persistence of Teacher-Induced Learning Gains by Jacob, Lefgren, & Sims.
• Economist Jesse Rothstein found that students' learning decays over time, and that the teachers who had the biggest added value gains at the end of the first year didn't necessarily have the biggest gains at the end of years two or three when the same students were retested. According to the Rothstein paper, "Three aspects of the results are of note. First, there is much more variation in fourth grade teachers' effects on fourth grade scores than in those same teachers' effects on fifth grade scores. [...] Second, the average persistence of fourth grade teachers' effects one year later is only around 0.3, again consistent with recent evidence. Third, the data are not even approximately consistent with the notion that this persistence rate is uniform across teachers: The correlation between teachers' first-year effects and their two year cumulative effects is much less than one, ranging between .33 and .51 depending on the model and subject. Three-year cumulative effects show a similar pattern, correlated around .4 with the immediate effect. Even if we assume that the VAM-based estimates can be treated as causal, a teacher's first-year effect is a poor proxy for his or her longer-run impact. [...] Only about a third of teachers in the top quintile of the distribution of two year cumulative effects are also in the top quintile of the one-year effect distribution. It is apparent that misspecification of the outcome variable produces extreme amounts of misclassification. [...] A full account of the utility of VAMs for identifying good teachers would need to combine the analyses of lagged effects and endogenous classroom assignments. This would imply even higher rates of misclassification than are produced by either on its own." Source: Teaching Quality in Educational Production: Tracking, Decay, and Student Achievement by Jesse Rothstein
• "Nicholas D. Kristof, a columnist for the New York Times, described education as 'Our Greatest National Shame.' He said that the national school system was broken, but he saw a bright spot on the horizon. First, he wrote. 'good teachers matter more than anything; they are astonishingly important. It turns out that having a great teacher is far more important than being in a small class, or going to a good school with a mediocre teacher. A Los Angeles study suggested that four consecutive years of having a teacher from the top 25 percent of the pool would erase the black-white testing gap.' The Los Angeles study to which he referred was the analysis by Gordon, Kane, and Staiger. [...]
  
  The theory seemed reasonable, but still and all, it was only a theory. The fact was that the theory had never been demonstrated anywhere. No school or school district or state anywhere in the nation had ever proved the theory correct. Nowhere was there a real-life demonstration in which a district had identified the top quintile of teachers, assigned low-performing students to their classes, and improved the test scores of low-performing students so dramatically in three, four, or five years that the black-white test score gap closed." Source: The Death and Life of the Great American School System, p. 187
• "To be sure, if new laws or district policies specifically require that teachers be fired if their students' test scores do not rise by a certain amount or reach a certain threshold, then more teachers might well be terminated than is now the case. But there is no current evidence to indicate either that the departing teachers would actually be the weakest teachers, or that the departing teachers would be replaced by more effective ones. Nor is there empirical verification for the claim that teachers will improve student learning if teachers are evaluated based on test score gains or are monetarily rewarded for raising scores." Source: Problems with the use of student test scores to evaluate teachers

Value-Added Assessment of Teachers - Statistical Problems

• "Economist Dale Ballou wrote in 2002 that value-added assessment was 'useful when viewed in context by educators who understand local circumstances,' but that it was potentially dangerous when used for accountability and high-stakes personnel decisions. The tests were not accurate enough to serve as the basis for high-stakes decisions. Test scores, he wrote, were affected not only by students' ability and by random influences (such as the weather or students' emotional state), but also by statistical properties such as measurement error and random error. These errors affect student scores, and they get 'noisier' (less reliable) when used to calculate gain scores and then to attribute the gains to a specific teacher. Gain scores, he pointed out, are influenced by factors other than teachers and schools; social and demographic factors affect not only the starting point but the rate of progress' that students make. Yet, he noted, most value-added methods do not control for those non-school factors. Also problematic was that gain scores are not necessarily comparable, because test questions are not of equal difficulty. If the gains are not comparable, then the results are meaningless, he said. Ballou [...] warned that 'there are too many uncertainties and inequities to rely on such measures for high-stakes personnel decisions.'" Source: The Death and Life of the Great American School System, p. 184
• "A number of factors have been found to have strong influences on student learning gains, aside from the teachers to whom their scores would be attached. These include the influences of students' other teachers-both previous teachers and, in secondary schools, current teachers of other subjects-as well as tutors or instructional specialists, who have been found often to have very large influences on achievement gains. These factors also include school conditions-such as the quality of curriculum materials, specialist or tutoring supports, class size, and other factors that affect learning. Schools that have adopted pull-out, team teaching, or block scheduling practices will only inaccurately be able to isolate individual teacher "effects" for evaluation, pay, or disciplinary purposes.
  
  Student test score gains are also strongly influenced by school attendance and a variety of out-of-school learning experiences at home, with peers, at museums and libraries, in summer programs, on-line, and in the community. Well- educated and supportive parents can help their children with homework and secure a wide variety of other advantages for them. Other children have parents who, for a variety of reasons, are unable to support their learning academically. Student test score gains are also influenced by family resources, student health, family mobility, and the influence of neighborhood peers and of classmates who may be relatively more advantaged or disadvantaged.
  
  Teachers' value-added evaluations in low-income communities can be further distorted by the summer learning loss their students experience between the time they are tested in the spring and the time they return to school in the fall. Research shows that summer gains and losses are quite substantial. A research summary concludes that while students overall lose an average of about one month in reading achievement over the summer, lower-income students lose significantly more, and middle-income students may actually gain in reading proficiency over the summer, creating a widening achievement gap. Indeed, researchers have found that three-fourths of schools identified as being in the bottom 20% of all schools, based on the scores of students during the school year, would not be so identified if differences in learning outside of school were taken into account. Similar conclusions apply to the bottom 5% of all schools.
  
  For these and other reasons, even when methods are used to adjust statistically for student demographic factors and school differences, teachers have been found to receive lower 'effectiveness' scores when they teach new English learners, special education students, and low-income students than when they teach more affluent and educationally advantaged students. The nonrandom assignment of students to classrooms and schools-and the wide variation in students' experiences at home and at school-mean that teachers cannot be accurately judged against one another by their students' test scores, even when efforts are made to control for student characteristics in statistical models." Source: Problems with the use of student test scores to evaluate teachers
• "The problems of measurement error and other sources of year-to-year variability are especially serious because many policy makers are particularly concerned with removing ineffective teachers in schools serving the lowest-performing, disadvantaged students. Yet students in these schools tend to be more mobile than students in more affluent communities. In highly mobile communities, if two years of data are unavailable for many students, or if teachers are not to be held accountable for students who have been present for less than the full year, the sample is even smaller than the already small samples for a single typical teacher, and the problem of misestimation is exacerbated.
  
  Yet the failure or inability to include data on mobile students also distorts estimates because [...] the students with complete data are not representative of the class as a whole. Even if state data systems permit tracking of students who change schools, measured growth for these students will be distorted, and attributing their progress (or lack of progress) to different schools and teachers will be problematic." Source: Problems with the use of student test scores to evaluate teachers
• "Even in a more stable community, the number of students in a given teacher's class is often too small to support reliable conclusions about teacher effectiveness. The most frequently proposed solution to this problem is to limit VAM to teachers who have been teaching for many years, so their performance can be estimated using multiple years of data, and so that instability in VAM measures over time can be averaged out. This statistical solution means that states or districts only beginning to implement appropriate data systems must wait several years for sufficient data to accumulate. More critically, the solution does not solve the problem of nonrandom assignment, and it necessarily excludes beginning teachers with insufficient historical data and teachers serving the most disadvantaged (and most mobile) populations, thus undermining the ability of the system to address the goals policy makers seek." Source: Problems with the use of student test scores to evaluate teachers

Value-Added Assessment of Teachers - Practical Problems with Implementation

• "[One] limitation of value-added assessment is that it applies only to those teachers for whom yearly test scores are available, possibly a minority of a school's staff. New teachers, those with less than three to five years of experience, cannot be evaluated, because there is not enough long-term test score data. Teachers of history, social studies, the arts, science, technology, physical education, and foreign languages cannot be evaluated, because their subjects are not regularly tested. Only teachers of reading and mathematics in elementary and middle schools can be evaluated, and they can be evaluated only if scores are available from the previous year and only if they have been teaching for at least three years." Source: The Death and Life of the Great American School System, p. 185
• "Research shows that an excessive focus on basic math and reading scores can lead to narrowing and over-simplifying the curriculum to only the subjects and formats that are tested, reducing the attention to science, history, the arts, civics, and foreign language, as well as to writing, research, and more complex problem-solving tasks.
  
  Tying teacher evaluation and sanctions to test score results can discourage teachers from wanting to work in schools with the neediest students, while the large, unpredictable variation in the results and their perceived unfairness can undermine teacher morale. Surveys have found that teacher attrition and demoralization have been associated with test- based accountability efforts, particularly in high-need schools.
  
  Individual teacher rewards based on comparative student test results can also create disincentives for teacher collaboration. Better schools are collaborative institutions where teachers work across classroom and grade-level boundaries toward the common goal of educating all children to their maximum potential. A school will be more effective if its teachers are more knowledgeable about all students and can coordinate efforts to meet students' needs." Source: Problems with the use of student test scores to evaluate teachers
• "Statistical models cannot fully adjust for the fact that some teachers will have a disproportionate number of students who may be exceptionally difficult to teach (students with poorer attendance, who have become homeless, who have severe problems at home, who come into or leave the classroom during the year due to family moves, etc.) or whose scores on traditional tests are frequently not valid (e.g., those who have special education needs or who are English language learners). In any school, a grade cohort is too small to expect each of these many characteristics to be represented in the same proportion in each classroom. [...]
  
  Purposeful, nonrandom assignment of students to teachers can be a function of either good or bad educational policy. Some grouping schemes deliberately place more special education students in selected inclusion classrooms or organize separate classes for English language learners. Skilled principals often try to assign students with the greatest difficulties to teachers they consider more effective. Also, principals often attempt to make assignments that match students' particular o the instructional strengths of individual teachers. Some teachers are more effective with students with particular characteristics, and principals with experience come to identify these variations and consider them in making classroom assignments.
  
  In contrast, some less conscientious principals may purposefully assign students with the greatest difficulties to teachers who are inexperienced, perhaps to avoid conflict with senior staff who resist such assignments. Further- more, traditional tracking often sorts students by prior achievement. Regardless of whether the distribution of students among classrooms is motivated by good or bad educational policy, it has the same effect on the integrity of VAM analyses: the nonrandom pattern makes it extremely difficult to make valid comparisons of the value-added of the various teachers within a school.
  
  In sum, teachers' value-added effects can be compared only where teachers have the same mix of struggling and successful students, something that almost never occurs, or when statistical measures of effectiveness fully adjust for the differing mix of students, something that is exceedingly hard to do." Source: Problems with the use of student test scores to evaluate teachers
• "Most secondary school teachers, all teachers in kindergarten, first, and second grades and some teachers in grades three through eight do not teach courses in which students are subject to external tests of the type needed to evaluate test score gains. And even in the grades where such gains could, in principle, be measured, tests are not designed to do so.
  
  Value-added measurement of growth from one grade to the next should ideally utilize vertically scaled tests, which most states (including large states like New York and California) do not use. In order to be vertically scaled, tests must evaluate content that is measured along a continuum from year to year. Following an NCLB mandate, most states now use tests that measure grade-level standards only and, at the high school level, end-of-course examinations, neither of which are designed to measure such a continuum. These test design constraints make accurate vertical scaling extremely difficult. Without vertically scaled tests, VAM can estimate changes in the relative distribution, or ranking, of students from last year to this, but cannot do so across the full breadth of curriculum content in a particular course or grade level, because many topics are not covered in consecutive years. For example, if multiplication is taught in fourth but not in fifth grade, while fractions and decimals are taught in fifth but not in fourth grade, measuring math 'growth' from fourth to fifth grade has little meaning if tests measure only the grade level expectations. Furthermore, the tests will not be able to evaluate student achievement and progress that occurs well below or above the grade level standards." Source: Problems with the use of student test scores to evaluate teachers
• "To practice value-added assessment, we must be able to compare the achievement gains of different students in a meaningful way. We need to be assured that the scale on which we measure achievement is one of equal units: one student's five-point increase on an achievement test, from 15 to 20, must represent the same gain as another student's five-point increase from 25 to 30. If it does not, we will end up drawing false conclusions about the relative effectiveness of these students' teachers and schools.
  
  Mathematicians who specialize in measurement in the social sciences, together with experts in the construction and interpretation of tests-psychometricians-have devoted considerable attention to this matter. Their findings are highly unfavorable to value-added assessment. [...] In practice, psychometricians usually act as if ability scores are on an equal-unit scale (or, in technical terms, an "interval" scale). But this is merely an assumption of convenience. As prominent psychometricians have pointed out, many of the usual procedures for comparing achievement gains yield meaningless results if the ability scales lack this property. [...]
  
  Our efforts to determine which students gain more than others-and thus which teachers and schools are more effective—turn out to depend on conventions (arbitrary choices) that make some educators look better than others. This does not mean that testing is of no value. It is still possible to rank students' performance and to ask how many students exceed a specified benchmark. But the finer kinds of measurement required to compare the progress of students at different levels of initial ability exceed the capacities of our instruments." Source: Size Up Test Scores by Dale Ballou.
• "It is often quite difficult to match particular students to individual teachers, even if data systems eventually permit such matching, and to unerringly attribute student achievement to a specific teacher. In some cases, students may be pulled out of classes for special programs or instruction, thereby altering the influence of classroom teachers. Some schools expect, and train, teachers of all subjects to integrate reading and writing instruction into their curricula. Many classes, especially those at the middle-school level, are team taught in a language arts and history block or a science and math block, or in various other ways. In schools with certain kinds of block schedules, courses are taught for only a semester, or even in nine or 10 week rotations, giving students two to four teachers over the course of a year in a given class period, even without considering unplanned teacher turnover. Schools that have adopted pull-out, team teaching, or block scheduling practices will have additional difficulties in isolating individual teacher 'effects' for pay or disciplinary purposes.
  
  Similarly, NCLB requires low-scoring schools to offer extra tutoring to students, provided by the school district or contracted from an outside tutoring service. High quality tutoring can have a substantial effect on student achievement gains. If test scores subsequently improve, should a specific teacher or the tutoring service be given the credit?" Source: Problems with the use of student test scores to evaluate teachers
• "To rectify obstacles to value-added measurement presented both by the absence of vertical scaling and by differences in summer learning, schools would have to measure student growth within a single school year, not from one year to the next. To do so, schools would have to administer high stakes tests twice a year, once in the fall and once in the spring. While this approach would be preferable in some ways to attempting to measure value-added from one year to the next, fall and spring testing would force schools to devote even more time to testing for accountability purposes, and would set up incentives for teachers to game the value-added measures. However commonplace it might be under current systems for teachers to respond rationally to incentives by artificially inflating end-of-year scores by drill, test preparation activities, or teaching to the test, it would be so much easier for teachers to inflate their value-added ratings by discouraging students' high performance on a September test, if only by not making the same extraordinary efforts to boost scores in the fall that they make in the spring."

School Choice / Vouchers

• "Only a tiny percentage of eligible students [from failing schools under No Child Left Behind] asked to transfer to better schools. In California, less than 1 percent of eligible students in 'failing' schools sought to transfer to another school; in Colorado, less than 2 percent did; in Michigan, the number of transfers under NCLB was negligible; in Miami, where public school cheice was already commonplace, less than 1/2 of 1 percentt asked to move because of NCLB; in New Jersey, almost no eligible students transferred, because most districts had only one school at each grade level, and the state's urban districts did not have enough seats available in successful schools to accommodate students from 'failing' schools. Julian Betts of the Univeristy of California at San Diego questioned whether choice was even a successful strategy, because his own studies found that choice had little or no effect on student achievement.
  
  The scholars suggested many reasons why students were not transferring out of allegedly failing schools. In the first year or two, the letters informing parents of their right to switch their children to a better school were unclear or arrived too late, after the school year had already started. Even when the letters were clear and arrived on time, some parents did not want to send their children on a bus to a faraway school. In some districts, there were already so many public school choice programs that NCLB added nothing new. In others, there were far more eligible students than seats.
  
  But what was especially striking was that many parents and students did not want to leave their neighborhood school, even if the federal government offered them free transportation and the promise of a better school. The paretns of English-language learners tended to prefer their neighborhood school, which was familiar to them, even if the federal government said it was failing. A school superintendent told Betts that choice was not popular in his county, because 'most people want their local school to be succcessful, and because they don't find it convenient to get their children across town.' Some excellent schools failed to meet AYP [adequate yearly progress] because only one subgroup—usually children with disabilities—did not make adequate progress. In such schools, the children in every other subgroup did make progress, were very happy with the school, did not consider it a failing school, and saw no reason to leave.
  
  Thus, while advocates of choice were certain that most families wanted only the chance to escape their neighborhood school, the first four years of NCLB demonstrated the opposite. When offered a chance to leave their failing school and to attend a supposedly better school in another part of town, less than 5 percent—and in some cases, less than 1 percent—of students actually sought to transfer." Source: The Death and Life of the Great American School System, p. 99

Tenure / Unions

• Approximately 32% of new teachers quit within the first three years, and approximately 48% quit within the first five years. Source: Number and percentage distribution of teachers by years of teaching experience, stayer/mover/leaver status and selected school characteristics in the base year: 2008-09, Schools and Staffing Survey (SASS)
• For public school teachers, the percentage who leave in their first three years has increased from 8.7% (per year) in 1994-95 to 9.7% (per year) in 2008-09. Source: Percentage distribution of public school teachers by stayer, mover, and leaver status for selected teacher and school characteristics in the base year: 1994-95, 2000-01, 2004-05, and 2008-09, Schools and Staffing Survey (SASS)
• For private school teachers, the percentage who leave in their first three years has increased from 20.1% (per year) in 1994-95 to 22.9% (per year) in 2008-09. Source: Percentage distribution of private school teachers by stayer, mover, and leaver status for selected teacher and school characteristics in the base year: 1994-95, 2000-01, 2004-05, and 2008-09, Schools and Staffing Survey (SASS)
• In 2007-08, on average 2% of teachers were dismissed or did not have their contracts renewed. Source: Table 8. Average number of public school teachers and average number of public school teachers who were dismissed in the previous year or did not have their contracts renewed based on poor performance, by tenure status of teachers and state: 2007-08, Schools and Staffing Survey (SASS)

Charter Schools

• "From school year 1999-2000 to 2010-11, the number of students enrolled in public charter schools increased from 0.3 million to 1.8 million students. During this period, the percentage of all public schools that were public charter schools increased from 2 to 5 percent." Source: The Condition of Education 2013, p. 48
• "High-poverty schools, in which more than 75 percent of the students qualify for free or reduced-price lunch (FRPL) [...] comprised 21 percent of all public schools in 2010-11, [...] compared with 33 percent of charter schools." Source: The Condition of Education 2013, p. 78
• "On average, charter middle schools that hold lotteries are neither more nor less successful than traditional public schools in improving student achievement, behavior, and school progress. Participating schools had no significant impacts on math or reading test scores either a year or two years after students applied, other measures of academic progress (such as attendance or grade promotion), or student conduct within or outside of school. Being admitted to a study charter school did significantly and consistently improve both students' and parents' satisfaction with school." Source: The Evaluation of Charter School Impacts, U.S. Department of Education, 2010
• "The impact of charter middle schools on student achievement varies significantly across schools. Across 28 sites (covering 32 schools), the effects on reading scores after two years were estimated to be greater than zero in 11 sites and less than zero in 17 sites (with magnitudes ranging from -0.43 to +0.33 standard deviation units), with 4 of the individual site estimates statistically significant. The estimated effects on math scores were greater than zero in 10 sites and less than zero in 18 of the 28 sites (-0.78 to +0.65 standard deviation units), with 10 of the site estimates statistically significant." Source: The Evaluation of Charter School Impacts, U.S. Department of Education, 2010
• "Charter [middle] schools serving more low income or low achieving students had statistically significant positive effects on math test scores, while charter schools serving more advantaged students-those with higher income and prior achievement-had significant negative effects on math test scores. [...] There were also differential effects on reading achievement, with negative and significant impacts for study charter schools serving more advantaged students and no impacts for study charter schools serving fewer advantaged students." Source: The Evaluation of Charter School Impacts, U.S. Department of Education, 2010
• "Some operational features of charter middle schools are associated with more positive (or less negative) impacts on achievement. These features include smaller enrollments and the use of ability grouping in math or English classes. Although impacts differed for study charter schools with longer- versus shorter- hours of operations or higher versus lower revenue per student, these features were no longer significant once other school and student characteristics were controlled for. We found no statistically significant relationships between achievement impacts and the charter schools' policy environment, including the extent of its decision-making autonomy, the type of authorizer and how the authorizer held the school accountable, and whether it was operated by a private organization." Source: The Evaluation of Charter School Impacts, U.S. Department of Education, 2010
• "In our study, the average charter school impact was negative but not statistically significant. This finding is consistent with the other studies in the following ways:
  • Studies that covered a wide span of states and/or districts, like ours, also found nonpositive average impacts. Zimmer et al. (2009) found that impacts on achievement were negative and statistically significant in 2 states and not significant in 5 states. CREDO (2009) examined charter schools in 14 states and found average impacts to be negative and significant, but small in magnitude (-0.01 standard deviation in reading and -0.03 in mathematics). Eight other non-experimental studies included charter schools in a single state and covered 7 unique states in total. Authors estimated negative average charter school impacts in 4 states and positive and significant impacts in 3 states (with one study finding positive and significant impacts at the elementary school level but insignificant impacts at the middle school level).
  • The experimental studies found that charter schools serving large populations of disadvantaged and racial/ethnic minority group students had positive impacts. At first glance, our findings appear to be at odds with findings from previous lottery- based studies, which demonstrated positive and significant average impacts of attending a charter school on reading and mathematics test scores in five of six studies. However, previous lottery-based studies focused on large urban areas with large disadvantaged and racial/ethnic minority populations while our sample included a much broader mix of students. When we examined only sites in which the proportion of students eligible for free or reduced-price meals was above the sample median, the estimated charter school impact on mathematics achievement was positive and statistically significant. Similarly, the impact on mathematics achievement was positive at the charter school sites in large urban areas. In both cases, impacts on reading achievement were not statistically significant in the sites that most resembled the charter schools included in earlier lottery-based studies."
  Source: The Evaluation of Charter School Impacts, U.S. Department of Education, 2010

Merit Pay

• "Popular amoung business-minded reformers since the 1920s, merit pay was studied intensively at the National Center on Performance Incentives at Vanderbilt University, which released a major evaluation in September 2010. One group of middle-school teachers in Nashville was offered a bonus of $15,000 if they could raise test scores over a three-year period, while another group was not eligible for the bonus. At the end of the three years, there was no difference overall between the test scores of the students taught by the two groups of teachers. This was the most rigorous study ever conducted of merit pay, but it did not impress the U.S. Department of Education. Within days of the release of the Vanderbilt study, the department awarded nearly $500 million for merit pay programs and promised an additional $500 million in the future." Source: Source: The Death and Life of the Great American School System, p. 267, citing Teacher Pay For Performance: Experimental Evidence from the Project on Incentives in Teaching
• "The New York City Department of Education tried a different approach to performance pay: It offered schoolwide bonuses to schools that raised their scores. After distributing $56 million over three years, the city ended the program in 2011. A study by the Rand Corporation found that the bonus program had no effect on student performance or teachers' attitudes toward their jobs. Undeterred by the failure of its initiative, the city administration promised to find another merit pay plan that worked better. The city had previously tried a program that paid students to get higher test scores; that didn't work either. Source: The Death and Life of the Great American School System, p. 268, citing New York City Abandons Teacher Bonus Program, Cash Offers Not Enough to Improve Student Test Scores

Enrollment & Graduation Statistics

• "Between 1970 and 2011, the enrollment rate for children ages 3-4 (the ages at which children are typically enrolled in nursery or preschool) increased from 20 to 52 percent." Source: The Condition of Education 2013, p. 42
• "Some 10 percent of all elementary and secondary school students were in private schools in 2009-10." Source: The Condition of Education 2013, p. 50
• "Between 1990 and 2010, the percentage of public school students who were White decreased from 67 to 54 percent, and the percentage of those who were Hispanic increased from 12 percent to 23 percent." Source: The Condition of Education 2012
• By 2021 student enrollment is projected to be 48% white, 16% black, 27% hispanic, and 6% asian or pacific islander. Source: The Condition of Education 2013, p. 52
• "The number of children and youth ages 3-21 receiving special education services was 6.4 million in 2010-11, or about 13 percent of all public school students." Some 38 percent of all children and youth receiving special education services had specific learning disabilities, 22 percent had speech or language impairments, and 11 percent had other health impairments. Some 7% of students had intellectually disabilities, and emotional disturbances, developmental delay, and autism each accounted for 6 percent of children and youth served. Some 2% of students had multiple disabilities, and 1% had hearing impairments or orthopedic impairments. Source: The Condition of Education 2013, p. 58
• "The status dropout rate represents the percentage of 16- through 24-year-olds who are not enrolled in school and have not earned a high school credential (either a diploma or an equivalency credential such as a General Educational Development [GED] certificate). [...]
  
  Based on the CPS, the status dropout rate declined from 12 percent in 1990 to 7 percent in 2011. [...] Reflecting the overall decline in the status dropout rate between 1990 and 2011, the rates also declined for Whites (from 9 percent to 5 percent), Blacks (from 13 percent to 7 percent), and Hispanics (from 32 percent to 14 percent)." Source: The Condition of Education 2013, p. 128
• The averaged freshman graduation rate measures the percentage of public high school students who graduate on time with a regular diploma. The overall AFGR was higher for the graduating class of 2009-10 than it was for the class of 1990-91 (73.7 percent). Source: The Condition of Education 2013, p. 124
• "In 2011, about 14 percent of youth ages 16-24 were neither enrolled in school nor working. The percent neither enrolled in school nor working varied across age groups. For example, about 20 percent of youth ages 20-24 (approximately 4.2 million) were neither in school nor working, compared with 3 percent of youth ages 16-17." Source: The Condition of Education 2012, p. 74
• "In 1990-91, some 24 percent of regular public high schools [...] were low-retention schools (5 percent retained between 10 and 50 percent of their students and 19 percent retained between 51 and 70 percent). [...] The percentage [...] remained relatively [stable at] 26 percent through 2009-10." Source: The Condition of Education 2012, p. 48
• "As of August 2011, the maximum compulsory age of attendance was 18 years in 20 states and the District of Columbia (D.C.), 17 years in 11 states, and 16 years in 19 states." Source: The Condition of Education 2012

English Language Learners

• "The percentage of public school students in the United States who were English language learners was higher in 2010-11 (10 percent) than in 2002-03 (9 percent)." Source: The Condition of Education 2013, p. 54
• "In 2010-11, states in the West had the highest percentages of ELL students in their public schools. In 8 states, 10 percent or more of public school students were English language learners—Oregon, Hawaii, Alaska, Colorado, Texas, New Mexico, Nevada, and California [...] —with ELL students constituting 29 percent of public school enrollment in California. Thirteen states and the District of Columbia had percentages of ELL public school enrollment between 6 and 9.9 percent. In addition to the District of Columbia, these states were Oklahoma, Arkansas, Massachusetts, Nebraska, North Carolina, Virginia, Arizona, Utah, New York, Kansas, Illinois, Washington, and Florida. The percentage of ELL students in public schools was less than 3 percent in 13 states; this percentage was between 3 and 5.9 percent in 16 states." Source: The Condition of Education 2013, p. 54
• "In cities in 2009-10, ELL students made up an average of 14 percent of total public school enrollment, ranging from 11 percent in small cities to 18 percent in large cities. In suburban areas, ELL students constituted an average of 8 percent of public student enrollment, ranging from 7 percent in midsize suburban areas to 10 percent in large suburban areas. In towns, ELL students made up an average of 7 percent of public student enrollment, ranging from 6 percent in both distant and remote areas to 9 percent in fringe areas. Towns and rural areas are subdivided into fringe, distant, and remote according to their proximity to urban centers, with fringe being the closest to an urban center and remote being the farthest from one. In rural areas, ELL students made up an average of 4 percent of public student enrollment, ranging from 2 percent in distant areas to 4 percent each in fringe and remote areas." Source: The Condition of Education 2012, Tables A-8-1 and A-8-2

Funding

• In 2008, the United States spent $10,995 per student on elementary and secondary education, which was 35 percent higher than the Organization for Economic Co-operation and Development (OECD) average of $8,169. At the postsecondary level, U.S. expenditures per student were $29,910, more than twice as high as the OECD average of $13,461. Source: The Condition of Education 2012

Safety

• From 1992 to 2011, the rate of nonfatal crime [(theft and all violent crime)] against students declined from 181 to 49 crimes per 1,000 students at school, or from nearly 1 in 5 students in 1992 to about 1 in 20 students in 2011; away from school, the rate of nonfatal crime against students also declined from 173 to 38 crimes per 1,000 students."
  
  Violent crime includes serious violent crime (rape, sexual assault, robbery, and aggravated assault) and simple assault. Source: The Condition of Education 2013, p. 82
• "[Between 1992 and 2011], violent victimization rates declined from 68 to 24 violent victimizations per 1,000 students at school and from 94 to 17 violent victimizations per 1,000 students away from school.
  
  Serious violent crime rates declined from a peak of 22 serious violent crimes per 1,000 students at school in 1993 to 4 serious violent crimes per 1,000 students at school in 2011. Serious violent crime rates away from school decreased from 43 to 5 serious violent crimes per 1,000 students between 1992 and 2011." Source: The Condition of Education 2013, p. 84
• 4.7% of schools recorded at least one student with possession of a firearm or explosive device and and 39.7% of schools recorded at least one student with possession of a knife or sharp object. Source: The Condition of Education 2012, table A-14-1.
• In 2008-09, 28% of students age 12 - 18 reported being the victims of bullying in school. 18.8% reported being made fun of, called names, or insulted; 16.5% reported being the subject of rumors; 5.7% reported being threatened with harm; 9.0% reported being pushed, shoved, tripped, or spit on; 3.6% reported being/tried to make do things they did not want to do; 4.7% reported being excluded from activities on purpose; and 3.3% reported having their property intentionally destroyed. Source: Student Reports of Bullying and Cyber-Bullying: Results From the 2009 School Crime Supplement to the National Crime Victimization Survey
• "As a group, these studies present a wide range of estimates of the percentage of U.S. students subject to sexual misconduct by school staff and vary from 3.7 to 50.3 percent. Because of its carefully drawn sample and survey methodology, the AAUW report that nearly 9.6 percent of students are targets of educator sexual misconduct sometime during their school career presents the most accurate data available at this time." Source: Educator Sexual Misconduct: A Synthesis of Existing Literature
• "During the 2007-08 school year, a greater percentage of teachers in city schools (10 percent) reported being threatened with injury than teachers in town schools (7 percent) and suburban or rural schools (6 percent each). A greater percentage of teachers in city schools (5 percent) and suburban schools (4 percent) reported being physically attacked, compared to teachers in rural schools (3 percent).
  
  A greater percentage of secondary school teachers (8 percent) reported being threatened with injury by a student than elementary school teachers (7 percent). However, a greater percentage of elementary school teachers (6 percent) reported being physically attacked than secondary school teachers (2 percent). " Source: Indicators of School Crime and Safety: 2009
• "In 2007, 23 percent of students ages 12-18 reported that there were gangs at their schools. Overall, a smaller percentage of White students (16 percent) and Asian students (17 percent) reported a gang presence at school than Black students (38 percent) and Hispanic students (36 percent)." Source: Indicators of School Crime and Safety: 2009
• "In 2007, 22 percent of all students in grades 9-12 reported that someone had offered, sold, or given them an illegal drug on school property in the past 12 months." Source: Indicators of School Crime and Safety: 2009
• "Ten percent of students ages 12-18 reported that someone at school had used hate-related words against them, and more than one-third (35 percent) reported seeing hate-related graffiti at school in 2007. [...] With regard to the specific characteristic to which the hate-related word was directed, [...] 5 percent of students reported hate-related words concerning their race, 3 percent reported words related to their ethnicity, 2 percent each reported words concerning their religion or gender, and 1 percent each reported words related to their disability or sexual orientation." Source: Indicators of School Crime and Safety: 2009
• "In 2007, [...] 9 percent of males carried a weapon on school property, compared to 3 percent of females, and 29 percent of males carried a weapon anywhere, compared to 7 percent of females." Source: Indicators of School Crime and Safety: 2009
• "In 2007, approximately 5 percent of students ages 12-18 reported that they were afraid of attack or harm at school, and 3 percent reported that they were afraid of attack or harm away from school. In 2007, smaller percentages of White students (4 percent) and Asian students (2 percent) reported being afraid of attack or harm at school than their Black (9 percent) and Hispanic (7 percent) peers. [...] 7 percent of students ages 12-18 reported that they had avoided a school activity or one or more places in school in the previous 6 months because of fear of attack or harm: 3 percent of students avoided a school activity, and 6 percent avoided one or more places in school." Source: Indicators of School Crime and Safety: 2009
• "Between the 1999-2000 and 2007-08 school years, there was an increase in the percentage of public schools reporting the use of the following safety and security measures: controlled access to the building during school hours (from 75 to 90 percent); controlled access to school grounds during school hours (from 34 to 43 percent); students required to wear badges or picture IDs (from 4 to 8 percent); faculty required to wear badges or picture IDs (from 25 to 58 percent); the use of one or more security cameras to monitor school (from 19 to 55 percent); the provision of telephones in most classrooms (from 45 to 72 percent); and the requirement that students wear uniforms (from 12 to 18 percent)." Source: Indicators of School Crime and Safety: 2009
• "Between the 2003-04 and 2007-08 school years, there was an increase in the percentage of public schools reporting the drug testing of student athletes (from 4 to 6 percent), as well as an increase in the percentage of public schools reporting the drug testing of students in other extracurricular activities (from 3 to 4 percent)." Source: Indicators of School Crime and Safety: 2009
• In 2007-08, 11.1% of high schools required students to pass through metal detectors, 58.4% used random dog sniffs to check for drugs, 26.5% performed random sweeps for contraband (separate from the use of dogs), 76.6% used security cameras to monitor the school, and 8.9% required students to wear uniforms. Source: Indicators of School Crime and Safety: 2009, p. 136
• Recommended Reading:
  • Let's prevent peer victimization, not just bullying
  • Children's Exposure to Violence: A Comprehensive National Survey

LGBTQ

• "Lesbian, gay, and bisexual youth were significantly more likely to attempt suicide in the previous 12 months, compared with heterosexuals (21.5% vs 4.2%). Among lesbian, gay, and bisexual youth, the risk of attempting suicide was 20% greater in unsupportive environments compared to supportive environments." Source: The Social Environment and Suicide Attempts in Lesbian, Gay, and Bisexual Youth
• "The National Longitudinal Study of Adolescent Health followed a nationally representative sample of adolescents who were in grades 7 through 12 in 1994-1995. Data from the 1994-1995 survey and the 2001-2002 follow-up were analyzed. Three measures were used to assess nonheterosexuality: same-sex attraction, same-sex romantic relationships, and lesbian, gay, or bisexual (LGB) self-identification. Six outcomes were assessed: school expulsion; police stops; juvenile arrest; juvenile conviction; adult arrest; and adult conviction. Multivariate analyses controlled for adolescents' sociodemographics and behaviors, including illegal conduct. [...]
  
  Overall, nonheterosexual adolescents had between 1.25 and 3 times greater odds than their heterosexual peers of experiencing sanction, depending on the indicator of nonheterosexuality and the sanction examined. This elevated risk was present for boys and girls who indicated same-sex attraction and same-sex relationships and for girls who self-identified as LGB, even after controlling for nonheterosexual youths' greater engagement in minor and moderate transgressive behaviors (nonheterosexual youth do not engage in more violent behaviors than their peers)." Source: Criminal-Justice and School Sanctions Against Nonheterosexual Youth: A National Longitudinal Study
• The National Gay and Lesbian Task Force estimates that "between 20 percent and 40 percent of all homeless youth identify as lesbian, gay, bisexual or transgender (LGBT). Given that between 3 percent and 5 percent of the U.S. population identifies as lesbian, gay or bisexual, it is clear that LGBT youth experience homelessness at a disproportionate rate." Source: Lesbian, gay, bisexual and transgender youth: An epidemic of homelessness
• The 2011 National School Climate Survey used two methods to obtain a representative national sample of lesbian, gay, bisexual, and transgender (LGBT) youth: 1) outreach through national, regional, and local organizations that provide services to or advocate on behalf of LGBT youth, and 2) targeted advertising on the social networking site Facebook.
  
  The survey found that:
  • "84.9% of students heard "gay" used in a negative way (e.g., "that's so gay") frequently or often at school, and 91.4% reported that they felt distressed because of this language. 71.3% heard other homophobic remarks (e.g., "dyke" or "faggot") frequently or often."
  • "61.4% heard negative remarks about gender expression (not acting "masculine enough" or "feminine enough") frequently or often."
  • "56.9% of students reported hearing homophobic remarks from their teachers or other school staff, and 56.9% of students reported hearing negative remarks about gender expression from teachers or other school staff."
  • "81.9% were verbally harassed (e.g., called names or threatened) in the past year because of their sexual orientation, and 63.9% because of their gender expression."
  • "38.3% were physically harassed (e.g., pushed or shoved) in the past year because of their sexual orientation, and 27.1% because of their gender expression."
  • "18.3% were physically assaulted (e.g., punched, kicked, injured with a weapon) in the past year because of their sexual orientation, and 12.4% because of their gender expression."
  • "55.2% of LGBT students experienced electronic harassment in the past year (via text messages or postings on Facebook), often known as cyberbullying."
  • "60.4% of students who were harassed or assaulted in school did not report the incident to school staff, most often believing little to no action would be taken or the situation could become worse if reported."
  • "36.7% of the students who did report an incident said that school staff did nothing in response."
  • "29.8% of students skipped a class at least once in the past month because they felt unsafe or uncomfortable."
  • "31.8% missed at least one entire day of school in the past month because they felt unsafe or uncomfortable."
  • "Students who experienced higher levels of victimization because of their sexual orientation were three times as likely to have missed school in the past month than those who experienced lower levels (57.9% vs. 19.6%)."
  • "Students who experienced higher levels of victimization because of their gender identity were more than twice as likely to have missed school in the past month than those who experienced lower levels (53.2% vs. 20.4%)."
  • "Students who were more frequently harassed because of their sexual orientation or gender expression had lower grade point averages than students who were less often harassed (2.9 vs. 3.2)."
  • "Students who experienced higher levels of victimization in school because of their sexual orientation or gender expression were more than twice as likely to report that they did not plan to pursue any post-secondary education (e.g., college or trade school) than those who experienced lower levels (10.7% vs. 5.1%)."

Special Education

• As of 2009-10, 13.1% of students were receiving services for a disability. 4.9% were receiving services for a specific learning disability, 2.9% for speech or language impairments, 0.9% for an intellectual disability, 0.8% for an emotional disturbance, 0.2% for hearing impairments, 0.1% for orthopedic impairments, 1.4% for other health impairments, 0.1% for visual impairments, 0.3% for multiple disabilities, 0.8% for autism, 0.1% for traumatic brain injury, and 0.7% for developmental delay.

Distance Education

• "In 2009-10, some 53 percent of school districts in the United States had high school students enrolled in distance education courses. Twenty-two percent of districts that offered distance education courses in 2009-10 reported that students enrolled in regular high school programs could take a full course load in an academic term using only distance education courses, while 12 percent reported that students could fulfill all high school graduation requirements using only distance education. In 2009-10, the most widely used technology for the instructional delivery of distance education courses was via the internet using asynchronous (not simultaneous) instruction, with 63 percent of districts that offered distance education courses reporting this as the prime delivery mode." Source: The Condition of Education 2012
• In the 53 percent of public school districts that had high school students enrolled in distance education courses, there were over 1.3 million high school student enrollments in distance education in 2009-10. This is compared to 0.3 million 5 years earlier. Source: The Condition of Education 2012

Student Employment

• "Between 1990 and 2010, the percentage of high school students ages 16 or older who were employed decreased from 36 percent to 16 percent." In 1980, some 21 percent of high school students were employed for 15 hours per week or more, and an additional 14 percent were employed for up to 15 hours per week; these percentages declined to 8 percent and 7 percent, respectively, by 2010. Source: The Condition of Education 2012, p. 76, table A-30-1

K12 Funding

• "From school years 1988-89 through 2008-09, total elementary and secondary public school revenues increased from $350 billion to $611 billion (in constant 2010-11 dollars), a 74 percent increase. During this period, the total amounts from each revenue source (federal, state, and local) increased." Source: The Condition of Education 2012, p. 54
• "Total expenditures per student in fall enrollment in public elementary and secondary schools rose from $8,634 in 1988-89 to $12,643 in 2008-09, a 46 percent increase as measured in constant 2010-11 dollars. [...] Spending on interest on school debt per student had the highest percent increase (149 percent, from $141 to $351), followed by capital outlay, e.g., buildings, at 117 percent (from $637 to $1,383) and employee benefits at 75 percent (from $1,267 to $2,222)." Source: The Condition of Education 2012, p. 54
• "From 1988-89 through 2008-09, combined salary and employee benefit expenditures per student increased by 38 percent, with the salary component increasing by 29 percent and the employee benefits component increasing by 75 percent. During this period, the amount of current expenditures spent on purchased services, e.g., contractor services, increased 62 percent. [...]
  
  Whereas expenditures per student for salaries have increased by 29 percent between 1988-89 and 2008-09, salaries for teachers and other staff have remained nearly flat. The increase in salary expenditures results from increases in staff greater than the increase in students." Source: The Condition of Education 2012, p. 54
• "In the 2008-09 school year, 61 percent of the $10,909 spent on current expenditures in public elementary and secondary schools went toward instruction expenditures such as salaries and benefits of teachers. About 11 percent went towards administration, 10 percent toward student and staff support; 10 percent for operation and maintenance; 4 percent each for transportation and food services; and less than 1 percent for enterprise operations." Source: The Condition of Education 2012, p. 54

Student Poverty

• "High-poverty schools, in which more than 75 percent of the students qualify for free or reduced-price lunch (FRPL) [...] comprised 21 percent of all public schools in 2010-11, compared with 12 percent in 1999-2000." Source: The Condition of Education 2013, p. 78
• "In 2010-11, some 24 percent of public school students attended a low-poverty school, compared with 45 percent in 1999-2000." Source: The Condition of Education 2013, p. 80
• "In 2010-11, some 21 percent of traditional public schools were high poverty, compared with 33 percent of charter schools." Source: The Condition of Education 2013, p. 78

Recommended Reading

• Recommended articles:
  • School ‘Reform': A Failing Grade
  • The Myth of Charter Schools
  • Diane Ravitch - What I have learned about school reform
  • AAAS: redesigning the science Advanced Placement exams
  • Gates Foundation Wastes More Money Pushing VAM
  • The 50 million dollar lie
  • Should Kids Go to Jail for Skipping School?
  • The Writing Revolution
  • Why You Truly Never Leave High School
  • A Textbook Example of What's Wrong with Education
  • Afraid of Your Child's Math Textbook? You Should Be.
  • Critical Thinking: Why Is It So Hard to Teach?
  • What You Need to Know About Your Child's Privacy Rights
  • Test Scores Sink as New York Adopts Tougher Benchmarks
  • Youngest Kid, Smartest Kid?
• Recommended Books:
  • The Death and Life of the Great American School System: How Testing and Choice Are Undermining Education
  • Equality and Achievement: An Introduction to the Sociology of Education
  • Visible Learning: A Synthesis of Over 800 Meta-Analyses Relating to Achievement
  • Meaningful Differences in the Everyday Experience of Young American Children
  • No Contest: The Case Against Competition
  • Punished by Rewards: The Trouble with Gold Stars, Incentive Plans, A's, Praise, and Other Bribes
  • The Schools Our Children Deserve: Moving Beyond Traditional Classrooms and "Tougher Standards"
  • The Homework Myth: Why Our Kids Get Too Much of a Bad Thing
  • The World We Created at Hamilton High
  • The Underground History of American Education: A School Teacher's Intimate Investigation Into the Problem of Modern Schooling
  • A list of more books and articles on education that I recommend: Introduction to Education Research
• Recommended essays:
  • The Six-Lesson Schoolteacher
  • A Mathematician's Apology
  • A Mathematician's Lament
  • The Age of the Essay

College education

College Tuition

• The total average yearly sticker price —including books and supplies, on campus room and board, and other expenses— of attending a full-time 4-year undergraduate program at a public institution in 2010-11 was $19,478 for in-state residents and $28,924 for out-of-state residents. The total cost at private non-profit institutions was $35,675 and $34,922 at private for-profit institutions.
  
  The average net price (total price of attendance minus all grants) in 2007-08 was $13,600 at public doctorate-granting institutions, $23,800 at private non-profit doctorate-granting institutions, and $18,400 at for-profit institutions. Source: Table 14. Average academic year price of attendance (in constant 2010-11 dollars) and percentage change in average price of attendance for full-time, first-time degree/certificate-seeking undergraduates at Title IV institutions, by level and control of institution, student housing, and residency: United States, academic years 2008-09 and 2010-11, Table 4.1-B. Average net price (price of attendance minus all grants) among undergraduates, by type of institution and selected student characteristics: 2007-08
• The total average sticker price for tuition, fees, room and board (TFRB) at private non-profit 4-year colleges increased from $16,611 in 1972-73 (2012 dollars) to $39,518 in 2012-13. At public 4-year colleges the cost increased from $7,972 to $17,860.
  
  The net TFRB (sticker price minus total grant aid and tax benefits) at public 4-year colleges for in-state residents increased from $7,400 in 1990-91 (2012 dollars) to $12,110 in 2012-13. At private non-profit institution the net price increased from $18,330 in 1990-91 to $23,840 in 2012-13. Source: CollegeBoard - Tuition and Fee and Room and Board Charges over Time in 2012 Dollars, 1972-73 through 2012-13, Selected Years, Table 7 - Average Net Price for Full-Time Students over Time - Public Institutions, Table 8 - Average Net Price for Full-Time Students over Time - Private Institutions
• The average yearly tuition and required fees (not including room and board) for full-time students in 4-year undergraduate programs at public institutions in 2010-11 was $6,752 for in-state residents and $15,742 for out-of-state residents. It was $21,996 at private non-profit institutions and was $15,700 at private for-profit institutions.
  
  The average net tuition (tuition and fees minus all grants) in 2007-08 was $4,900 at public doctorate-granting institutions, $16,400 at private non-profit doctorate-granting institutions, and $9,200 at for-profit institutions. Source: Table 7. Average and median tuition and required fees and number of institutions reporting academic year tuition and required fees for full-time students at Title IV institutions, by control of institution, residency, student level, and level of institution: United States, academic year 2010-11, Table 4.1-D. Average net tuition (tuition and fees minus all grants) among undergraduates, by type of institution and selected student characteristics: 2007-08
• The average sticker price for yearly tuition and required fees (not including room and board) at private non-profit 4-year institutions increased from $10,378 in 1972-73 (2012 dollars) to $29,056 in 2012-13. At public institutions the cost increased from $2,225 to $8,655.
  
  The net yearly tuition and required fees (sticker price minus total grant aid and tax benefits) at public 4-year colleges for in-state residents increased from $1,840 in 1990-91 (2012 dollars) to $2,910 in 2012-13 . At private non-profit institutions the net price increased from $11,060 in 1990-91 to $13,380 in 2012-13. Source: CollegeBoard - Tuition and Fee and Room and Board Charges over Time in 2012 Dollars, 1972-73 through 2012-13, Selected Years, Table 7 - Average Net Price for Full-Time Students over Time - Public Institutions, Table 8 - Average Net Price for Full-Time Students over Time - Private Institutions

Student Loan Debt

• In 2009 65.6% of first-time bachelor's degree recipients took out student loans, compared with 49.3% in 1994. Of those who borrowed, the cumulative amount borrowed was $24,700 in 2009, as compared with $14,700 (2009 dollars) in 1994. Source: Trends in Debt for Bachelor's Degree Recipients a Year After Graduation: 1994, 2001, and 2009 (Table 1)
• 58.0% of all first-time bachelor's degree recipients still had outstanding student loans 1 year after graduation in 2009. The average amount owed by graduates with outstanding loans 1 year after graduation was $20,100, compared with $10,100 (2009 dollars) in 1994. Source: Trends in Debt for Bachelor's Degree Recipients a Year After Graduation: 1994, 2001, and 2009 (Tables 3, 4)
• Among first-time bachelor's degree recipients with loans and who were employed and repaying their loans 1 year after bachelor's degree receipt, the average monthly loan repayments were 13.1% of monthly salary in 2009, as compared with 11.1% in 1994. The median monthly loan repayments were 8.0% in 2009, as compared with 6.8% in 1994.
  
  In 2009 51.7% had monthly loan repayments that were 1-8% of their monthly salary, 17.1% had monthly loan repayments that were 9-12% of their monthly salary, 11.7% had monthly loan repayments that were 13-17% of their monthly salary, and 19.4% had monthly loan repayments that were more than 17% of their monthly salary. Source: Trends in Debt for Bachelor's Degree Recipients a Year After Graduation: 1994, 2001, and 2009 (Tables 6, 7)
• The 3-year borrower default rate for student loans was 13.4% for borrowers who entered repayment between October 1, 2008 and September 30, 2009. This rate was 11.0% for students at public universities, 7.5% for students at private universities, and 22.7% for students at proprietary (for-profit) universities. Source: FY 2009 Official National 3-Year Cohort Default Rates Calculated August 5 , 2012

College Enrollment

• "Some 10.6 million undergraduate students (58 percent of the total) attended 4-year institutions in fall 2011, while 7.5 million (42 percent of the total) attended 2-year institutions.
  
  Of undergraduate students at 4-year institutions that year, 8.2 million, or 78 percent, attended full time. Of undergraduate students at 2-year institutions that year, 3.2 million (42 percent) were full-time students and 4.3 million (58 percent) were part-time students." Source: The Condition of Education 2013, p. 146
• "Of the 18 million undergraduate students at degree-granting institutions in the United States in fall 2010, some 76 percent attended public institutions, 15 percent attended private nonprofit institutions, and 10 percent attended private for-profit institutions." Source: The Condition of Education 2012, p. 90
• During the 2008-09 academic year, there were a total of 8,803,240 full-time students enrolled in 4-year institutions. Of these, 61.6% were enrolled in public institutions, 26.9% were enrolled in private not-for-profit institutions, and 11.5% were enrolled in private for-profit institutions. Source: Table 73. 12-month full-time-equivalent enrollment at Title IV institutions, by student level and institution sector: United States, academic year 2008-09
• "Between 2000 and 2010, undergraduate enrollment in degree-granting postsecondary institutions increased by 37 percent, from 13.2 to 18.1 million students. Projections indicate that undergraduate enrollment will continue to increase, reaching 20.6 million students in 2021." Source: The Condition of Education 2012
• "In 2010, the immediate college enrollment rate of high school completers from low-income families was 52 percent, 30 percentage points lower than the rate of high school completers from high-income families (82 percent). The immediate college enrollment rate of high school completers from middle-income families (67 percent) also trailed the rate of their peers from high-income families by 15 percentage points." Source: The Condition of Education 2012
• Between 1970 and 2010, the enrollment rate for 18- and 19-year-olds at the secondary level increased from 10 to 18 percent, while the rate at the college level rose from 37 to 51 percent. Source: The Condition of Education 2012, p. 16
• "Adults ages 20-34 who are in school are usually enrolled in college or graduate school. Between 1970 and 2010, the enrollment rate for adults ages 20-24 increased from 22 to 39 percent, and the rate for adults ages 25-29 increased from 8 to 15 percent. The enrollment rate for adults ages 30-34 increased from 4 percent in 1970 to 8 percent in 2010." Source: The Condition of Education 2012, p. 16

Degree Attainment

• "Between academic years 1999-2000 and 2009-10, the [...] number of associate's degrees awarded increased by 50 percent, bachelor's degrees increased by 33 percent, master's degrees increased by 50 percent, and doctor's degrees increased by 34 percent. For all postsecondary degree levels, the percentage increases from 1999-2000 to 2009-10 were smaller for public and private nonprofit institutions than for private for-profit institutions." Source: The Condition of Education 2012, p. 110
• "From 1980 to 2011, the percentage of 25- to 29-year-olds who had attained a bachelor's degree or higher increased from 25 to 39 percent for Whites, from 12 to 20 percent for Blacks, and from 8 to 13 percent for Hispanics. For Asians/Pacific Islanders, the attainment rate of at least a bachelor's degree in 2011 (56 percent) was higher than the rate in 1990 (42 percent). [...] In 2011, some 7 percent of 25- to 29-year-olds had completed at least a master's degree. From 1995 to 2011, the attainment rate of a master's degree or higher increased for Whites (from 5 to 8 percent), Blacks (from 2 to 4 percent), and Asians/Pacific Islanders (from 11 to 17 percent)." Source: The Condition of Education 2012, p. 114
• The percentage of Americans over age 25 who had received at least a bachelor's degree by year:
  
  1940 - 4.6%
  1950 - 6.2%
  1960 - 7.7%
  1970 - 10.7%
  1980 - 16.2%
  1990 - 20.3%
  2000 - 24.4%
  2011 - 30.4%
  
  Source: Census.gov - Table 5. Percent of the Total Population 25 Years and Over with a High School Diploma or Higher by Sex, for the United States, Regions, and States: 1940 to 2000, Census.gov - Table 2. Educational Attainment of the Population 25 Years and Over, by Selected Characteristics: 2011
• 58.3 percent of first-time, full-time students who began seeking a bachelor's degree at a 4-year institution in fall 2004 completed a bachelor's degree at that institution within 6 years or 150 percent of normal completion time to degree. These rates were 56.0% at public institutions, 65.4% at private not-for-profit institutions, and 28.4% at for-profit institutions.
  
  Graduation rates ranged from 87.2% at institutions that accepted less that 25.0% of applicants to 29.2% at institutions with open admissions. Graduation rates also varied by race: 61.5% for whites, 39.5% for blacks, 50.1% for hispanics, and 68.7% for asians.
  
  Source: nces.ed.gov - Table 345. Graduation rates of first-time postsecondary students who started as full-time degree/certificate-seeking students, by sex, race/ethnicity, time to completion, and level and control of institution where student started: Selected cohort entry years, 1996 through 2007
• At 2-year institutions, approximately 30 percent of first-time, full-time students who enrolled in fall 2007 completed a certificate or associate's degree within 150 percent of the normal time required to complete such a degree. For the cohort that enrolled in fall 2000, the completion rate was about 31 percent. The certificate or associate's degree completion rate of students who enrolled in 2-year institutions in fall 2007 varied by institutional control. For example, 60 percent of students graduated within 150 percent of the normal time at private for-profit institutions, 51 percent did so at private nonprofit institutions, and 20 percent did so at public institutions. Source: The Condition of Education 2012, p. 108
• As of 2011 17% of Americans over age 25 had some college but no degree. 9.5% had an associates degree, and 30.4% had a bachelor's degree or higher. Source: Census.gov - Table 2. Educational Attainment of the Population 25 Years and Over, by Selected Characteristics: 2011
• In 1960 women earned 35.2% of bachelor's degrees and men earned 64.8%. In 2009 women earned 57.2% of bachelor's degrees, and men earned 42.3%. Source: Census.gov: Table 299. Degrees Earned by Level and Sex: 1960 to 2009

Graduate Salaries

• "In 2010, young adults ages 25-34 with a bachelor's degree earned 114 percent more than young adults without a high school diploma or its equivalent, 50 percent more than young adult high school completers, and 22 percent more than young adults with an associate's degree." Source: The Condition of Education 2012, p. 116

Employment

• "According to the Current Population Survey (CPS), in 2011 about 41 percent of full-time undergraduate students and 74 percent of part-time undergraduate students ages 16 to 24 years old worked in addition to being enrolled in a postsecondary institution.
  
  Of full-time undergraduate students, 16 percent of college students who were employed reported working less than 20 hours per week, 18 percent reported working 20 to 34 hours per week, and 6 percent reported working 35 hours or more per week.
  
  By comparison, 11 percent of part-time undergraduate students who were employed reported working less than 20 hours per week while they attended school, another 28 percent reported working 20 to 34 hours per week, and 33 percent reported working 35 or more hours per week." Source: The Condition of Education 2013, p. 150
• In 2009 45.5% of employed first-time bachelor's degree recipients considered their current job to be closely related to their major, 27.0% considered it to be somewhat related to their major, and 23.1% considered it to be not at all related to their major. Source: Trends in Debt for Bachelor's Degree Recipients a Year After Graduation: 1994, 2001, and 2009 (Table 11)

College Majors

• "Of the 1.7 million bachelor's degrees awarded in academic year 2010-11, almost one-third were concentrated in two fields: business (21 percent) and social sciences and history (10 percent). Five other fields each accounted for 5 percent or more of all bachelor's degrees awarded. These were health professions and related programs, education, psychology, visual and performing arts, and biological and biomedical sciences. These are the same seven fields in which the largest numbers of bachelor's degrees were awarded in 2000-01." Source: The Condition of Education 2013, p. 153
• "Overall, the number of bachelor's degrees awarded increased by 472,000 degrees from academic year 2000-01 to 2010-11, reflecting an increase of 38 percent. During this period, the two largest fields of study, business and social sciences, had increases of 39 percent and 38 percent, respectively. Of the 20 major fields of study in which the most bachelor's degrees were awarded in 2010-11, the largest percentage increase in the number of bachelor's degrees awarded occurred in the field of parks, recreation, leisure, and fitness studies (from 17,900 to 35,900 degrees, an increase of more than 100 percent). In contrast, the number of degrees conferred declined in two fields from 2000-01 to 2010-11: Some 1,500 fewer bachelor's degrees were awarded in education (a decrease of 1 percent), and 1,100 fewer degrees were awarded in computer and information sciences (a decrease of 2 percent)." Source: The Condition of Education 2013, p. 153

Institutional Revenue and Expenses

• "In academic year 2009-10, instruction was the largest per-FTE-student expense at public ($7,239) and private nonprofit institutions ($15,321). At private for-profit institutions, instruction was the second largest expense category, at $3,017 per student." Source: The Condition of Education 2012
• "In academic year 2009-10, total expenses were $287 billion at public institutions, $148 billion at private nonprofit institutions, and $20 billion at private for-profit institutions. [...]
  
  Total expenses per full-time equivalent (FTE) student were much higher for private nonprofit institutions ($46,287 in 2009-10) than for public institutions ($26,697 in 2009-10) and private for-profit institutions ($12,683 in 2009-10). Private nonprofit institutions spent more than twice as much per student on instruction ($15,321) as public institutions ($7,239). Expenses per student for instruction were more than twice as high in public institutions as in private for-profit institutions ($7,239 vs. $3,017). " Source: The Condition of Education 2012, p. 104
• "In academic year 2009-10, total revenue was $309 billion (in constant 2010-11 dollars) at public postsecondary degree-granting institutions, $172 billion at private nonprofit institutions, and $25 billion at private for-profit institutions. [...] Total revenues per student [were] $28,781 in 2009-10." Source: The Condition of Education 2012, p. 102
• At 4-year public institutions, total institution funding is divided into both operating revenues (for providing goods and services) and nonoperating revenues (for providing activities). In 2009-10, public institutions received 61.3% of their funding from operating revenues, 33.7% nonoperating revenues, and 5.0% from neither operating nor nonoperating revenue.
  
  Of operating revenues (61.3%), funding came from: tuition and fees (18.9%); government grants and contracts (16.4%); auxiliary enterprises (8.1%); hospitals (11.8%); and other operating revenues (6.1%). Of nonoperating revenues (33.7%), funding came from: government appropriations and grants (25.7%), gifts (2.3%), investment income (3.9%), other nonoperating revenue (1.9%). Other revenues (neither operating nor nonoperating) were 5.0%. Source: The Condition of Education 2012, p. 270
• Private non-profit and for-profit institutions do not have their institution funding divided into operating and nonoperating expenses by the National Center for Education Statistics.
  
  At 4-year private non-profit institutions in 2009-10, funding came from: tuition and fees (33.3%); federal, state, and local governments (14.9%); private gifts, grants, and contracts (10.7%); investment return (16.9%); educational activities (2.9%); auxiliary enterprises (8.4%); hospitals (9.8%); and other sources (3.2%)
  
  At 4-year private for-profit institutions in 2009-10, funding came from: tuition and fees (91.2%); federal, state, and local governments (6.9%); private gifts, grants, and contracts (0.2%); investment return (0.2%); educational activities (2.0%); auxiliary enterprises (2.0%); and other sources (-2.4%). Source: The Condition of Education 2012, p. 270

Mal-employment of College Graduates

• "About 48 percent of employed U.S. college graduates are in jobs that the Bureau of Labor Statistics (BLS) suggests requires less than a four-year college education. Eleven percent of employed college graduates are in occupations requiring more than a high-school diploma but less than a bachelor's, and 37 percent are in occupations requiring no more than a high-school diploma." Source: Why Are Recent College Graduates Underemployed?. See also Occupational employment, job openings and worker characteristics and Educational attainment for workers 25 years and older by detailed occupation
• According to the Bureau of Labor Statistics, there are 41.7 million employed college graduates, and only 28.6 million jobs requiring a college degree. There are over 13 million more working college graduates than jobs requiring a bachelor's degree or more. Also, several million jobs requiring bachelor's degrees are in fact filled with those with lesser education, so the actual number of college graduates in jobs requiring less than a college degree is over 20 million. Source: Why Are Recent College Graduates Underemployed?, p. 12
• "One objection that could be raised is that many the fastest-growing occupations of the future, according to BLS projections, are areas like biomedical engineering (the STEM disciplines) and other highly skilled occupations. Yet that assertion is, at the minimum, exaggerated. It is true that sometimes these highly skilled occupations are projected to have a relatively large percentage increase in jobs—biomedical engineering, for example, is predicted by the BLS to face a 62 percent growth in the decade 2010 to 2020, the third highest of any occupation (lower, however, than personal care or home health aides, neither of which require a college degree). While that sounds impressive, the number of biomedical engineers in 2011 was 16,590, so a 62 percent increase means roughly 10,000 new jobs, a relatively small number. By contrast, a mere 21.3 percent increase in the projected number of construction laborers means 212,400 new jobs—21 times as many new jobs as in biomedical engineering.
  
  It is instructive to examine the 30 jobs with the largest projected growth in numbers from 2010 to 2020. [...] Of the 30 jobs, only seven are positions requiring any postsecondary education whatsoever, and only four require a bachelor's degree or more. Indeed, more positions (10) require, in the BLS estimation, less than a high-school education, than require any form of postsecondary training.
  
  Even those statistics somewhat overstate the importance of more education in meeting the skill requirements of new jobs in the future. The 30 occupations listed in the table are expected to add nearly 9.3 million jobs in this decade, but barely 900,000 (or less than 10 percent) are in fields where the BLS believes a bachelor's degree or more is required. Even if one adds in the three other occupations requiring some postsecondary training (most importantly registered nurses), the total jobs in occupations requiring some higher education experience rises to slightly fewer than 2.1 million, less than 23 percent of the total projected employment increase in the largest-growing occupations." Source: Why Are Recent College Graduates Underemployed?, p. 17
• "According to our estimates, we project that the number of adult Americans with bachelor's degrees will grow over 31 percent during the current decade [between 2010 and 2020], more than double the percentage growth (14 percent) in jobs requiring at least a bachelor's degree. We are essentially creating a glut of overeducated persons who will be forced to perform relatively simple unskilled tasks requiring little in the way of educational skills. [...]
  
  The number of college graduates is expected to grow by 19 million, while the number of jobs requiring a bachelor's degree is expected to growth by fewer than 7 million. We are expected to create nearly three new college graduates for every new job requiring such an education. Currently, more than 20 million college graduates are underemployed—working in jobs requiring less education than they have, but that number will likely soar to nearly 30 million in the coming decade as a consequence of the number of graduates growing by 12 million more than the number of jobs." Source: Why Are Recent College Graduates Underemployed?, p. 20
• A college graduate is considered mal-employed when the accept work in occupations that do not typically use the skills, knowledge, and abilities usually developed through a college education. A 2011 study by Drexel University economists found that the mal-employment rate for college gruadates across all age groups has increased from 25.2% in 2000 to 28.2% in 2010, and the mal-employment rate for college graduates age 20-24 has increased from 29.8% in 2000 to 39.1% in 2010. The mal-employment rate for college graduates age 25-29 also increased from 23.5% in 2000 to 29.9% in 2010. Source: Rising Mal-Employment and the Great Recession: The Growing Disconnection between Recent College Graduates and the College Labor Market
• "Among all employed college graduates, those working in a CLM [college labor market] occupation earned almost twice as much (95 percent more) as those who were mal-employed. This annual earnings premium from working in a CLM occupation stood at 77 percent among workers with a bachelor's degree, 66 percent among those with a master's degree, and 139 percent among workers with a doctorate or a professional degree.
  
  The earnings premiums when gaining access to employment in CLM occupations at each college-degree level were also quite large among workers who were employed in full-time year-round jobs: a 68 percent earnings advantage among workers with any (bachelor's or higher) college degree and 54 percent, 39 percent, and 89 percent earnings advantage among workers with a bachelor's, master's, and doctorate/professional degree, respectively." Source: Rising Mal-Employment and the Great Recession: The Growing Disconnection between Recent College Graduates and the College Labor Market

Recommended Reading

• With Goldman's Foray Into Higher Education, A Predatory Pursuit of Students and Revenues
• The Reproduction of Privilege
• New Normal: Majority Of Unemployed Attended College. See also: Labor Force Statistics from the Current Population Survey
• Thousands of veterans failing in latest battlefield: college
• Death by Degrees
• The Painful Truth About Affirmative Action
• Asians: Too Smart for Their Own Good?
• How tougher classes in high school can help kids make it through college
• Napster, Udacity, and the Academy

Poverty & Financial Insecurity

Military

Capital

Media