Marcia Angell is a member of the faculty of Global Health and Social Medicine at Harvard Medical School and the former Editor in Chief of The New England Journal of Medicine. (June 2017)
The US Food and Drug Administration (FDA) is a vital public agency. It is responsible for ensuring the safety of the foods we eat and many of the medical treatments we receive, and thereby regulates about a quarter of the nation’s domestic economy. I strongly believe in the FDA’s mission, and respect the many FDA employees who are dedicated to carrying it out.
But there is growing evidence that the Center for Drug Evaluation and Research (CDER, pronounced “cedar”), the part of the agency that regulates prescription drugs, has become the servant of the industry it regulates. This has resulted in the sale of drugs of uncertain benefits, some with serious side effects, and in the agency’s failure to respond promptly to evidence that a drug is dangerous. There is no better example than the agency’s decision to allow the diabetes drug Avandia to remain on the market after having determined three years ago that it increases the risk of heart problems and despite the existence of a similar drug that appeared safer. Even after revelations that the drug’s maker, the British company GlaxoSmithKline, suppressed indications of problems and biased its research in Avandia’s favor, the FDA remained reluctant to pull the drug. By the end of August it was still unclear whether the agency would remove Avandia from the market.1
CDER also does not fulfill its obligation to oversee the marketing of prescription drugs, thus permitting misleading drug ads and illegal practices such as drug companies inducing doctors to prescribe drugs for uses that have not been approved by the FDA. Although nearly every major drug company has paid enormous fines to settle charges of illegal marketing (Pfizer’s recent $2.3 billion fine—for illegally promoting its painkiller Bextra and three other drugs—is the current record), they evidently consider the fines the cost of doing business, since the same practices keep recurring with little interference from CDER.
Americans use enormous amounts of prescription drugs. According to the Kaiser Family Foundation, 3.9 billion drug prescriptions were filled in the US in 2009, an average of 12.6 per person. Most people over age sixty-five take at least three prescription medications daily. Since the FDA is what stands between the public and an aggressive, profit-driven industry, its independence from the industry it regulates is of fundamental importance.
This is not an issue that receives much attention from Daniel Carpenter in his imposing new book, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, nor does the related question of whether CDER is doing its job of ensuring that the drugs we take in such huge quantities are really safe and effective. Instead, Carpenter, a professor of government at Harvard, spends 752 dense, exhaustively documented pages telling the reader virtually everything else about the FDA—its history, procedures, personalities, and politics. Like much academic work on public and social policy, it strives to be impartial. But it sees complexity even when it is not there (some things about the FDA are quite simple), and it remains oddly aloof from the issues that most matter.2 Its main value is as a reference work.
Here I’ll discuss the problem that Carpenter largely neglects—how to ensure that CDER, free of industry influence, protects the public from unsafe and useless drugs…..
Despite evidence of harm–including the suicide of a 7-year old Gabriel Myers– the FDA, which is charged with ensuring the safety of children in drug trials, fails to maintain a record of children enrolled in commercial drug trials.
By contrast, after the suicide of Gabriel Myers , a seven-year old boy in foster care who had been prescribed three powerful psychotropic drugs in a dubious clinical trial, George Sheldon, Florida’s Secretary of the Department of Children and Families, examined the records of children in State foster care and found a high percentage being drugged with psychotropic drugs:
“Not only was the percentage high, it was not really known. And, in more than a third of known cases, required approval permission documents were missing.”…