Is drug regulation failing?BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7477.0-g (Published 25 November 2004) Cite this as: BMJ 2004;329:0-g
Something is rotten at the heart of the FDA. The United States Food and Drug Administration, mired in controversy over the last 12 months, now faces an extraordinary charge of attempting to discredit a whistleblower. As this week's issue reveals, David Graham, the FDA's associate director of drug safety, was so bothered about the difficulties of presenting his data on rofecoxib (Vioxx) in the Lancet that he took his case to the Government Accountability Group, a public interest group that protects whistleblowers. What was extraordinary, reports Jeanne Lenzer on p 1255, was that an FDA manager then called the accountability group to rubbish Graham's account and accuse him of scientific misconduct. In a quandary, the accountability group checked both sides of the story, and found that Graham's version was perfectly credible, while the FDA agent's version failed every test of credibility. It says something of the turmoil within the FDA that when Graham returned to work after giving his damning testimony at Senate hearings—he described the approval of rofecoxib as the “single greatest drug safety catastrophe in the history of the world”—he received a standing ovation from his colleagues (p 1253).
His testimony raises serious questions about the ability of the FDA to fulfil its role as regulator. The dangers of rofecoxib were apparent eight years ago and not acted upon, the harms suppressed. What has now unfolded may be the most serious example of regulatory failings about drug related harm since the thalidomide scandal, suggests Graham. Apart from questions around scientific credibility and accusations of being too close to industry (BMJ 2004;329: 189), the FDA has spent much of the year defending itself against allegations that its decision not to offer over the counter emergency contraception—imaginatively named plan B—was politically motivated (BMJ 2004;328: 1219). Ray Moynihan offers another example that will test the FDA's decision making, this time around indication creep, with its fast track review of testosterone patches for hypoactive sexual disorder (p 1255, p 1294). The patches increase sexual activity by one “episode”—or less—per month.
Not that UK regulators need be smug. This year's paroxetine saga has tarred the Medicines and Healthcare products Regulatory Agency with the brush of industry bias (BMJ 2004;329: 865), and I was surprised to discover the extent to which senior policy makers at a meeting to discuss futures for the NHS saw the drug industry as an essential financer of research and development with barely an acknowledgement of issues of transparency, competing interests, and disentangling the relationship between drug companies and drug regulators. The FDA and MRHA are two of the world's leading drug regulators and their reputations have taken a battering. When will they show that their primary role is to protect the public and not to protect industry?
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