Observations Medicine and the media

Don't blame it all on the bogey

BMJ 2007; 334 doi: http://dx.doi.org/10.1136/bmj.39244.680880.59 (Published 14 June 2007) Cite this as: BMJ 2007;334:1250
  1. Michael Day, freelance journalist, London
  1. miday{at}f2s.com

    UK and European policymakers and journalists could learn a lot from the way in which their US counterparts are ready to turn the heat on drug regulators, not just on big pharma, writes Michael Day

    The newspapers love a bogeyman. And big pharma fits the bill perfectly. The image of obscenely well paid executives ripping off the NHS and poisoning the masses for the sake of quick profits has united newspapers of all political persuasions in a deep-held suspicion of the companies' method and motives.

    During my stint as the Sunday Telegraph's health correspondent, under the impeccably right-wing and laissez-fare reign of Dominic Lawson, bashing drugs companies always guaranteed you space in the paper. And bear in mind this was a publication that considered global warming something invented by Marxists in order to undermine the oil industry. If, however, you tried to move the argument on a little from “drugs companies are evil” to “the regulators are to blame,” news editors' eyes would glaze over.

    The British press has been quick to report concerns about “disease mongering” by the drugs industry as well as safety fears over Vioxx (rofecoxib), Seroxat (paroxetine), Avandia (rosiglitazone), and others. But it has largely been left to campaigners such as Charles Medawar in Social Audit to tackle the failings of the Medicines and Healthcare products Regulatory Agency—and to call for the heat to be turned up on the people who regulate drug companies, rather than simply demonising these profit-making organisations for cutting corners and doing what they do best . . . making profits.

    No so in the United States, where thorough newspaper reporting of the Food and Drug Administration's inadequacies has prompted members of the US Congress to now push for proper post-marketing surveillance of new medicines, and even for the FDA to be split into two separate bodies—one that awards drugs licences, and another that continues to monitor safety and has the power to rescind them.

    The real impetus behind these calls for change has been the Vioxx disaster. The agency's failure to act more quickly on Vioxx, and the behaviour of key figures within the organisation are probably the most alarming aspects of a new investigative documentary on the dark side of the pharmaceutical industry, We'll Take Care of You by Lattanzio Firmian and Alberto Baudo.

    The film makers begin with some predictable attacks on big pharma. Drugs company executives are portrayed as Wild West villains and predatory animals. Victims of drug side-effects are nice, ordinary Joes who were just fine until they started taking the tablets—though it's worth recapping the extent of the Vioxx scandal. Merck's own paper in the New England Journal of Medicine in June 2000 found that the drug increased users' risk of stroke or heart attack by four to five times. But despite this risk being in the public domain in June 2000, Merck continued to promote and sell the osteoarthritis treatment until its withdrawal in September 2004. By this time an estimated 60 000 people who had been prescribed the drug in the US alone had died from stroke or heart attack.

    But it's when the film focuses on the FDA's role in the affair that things get really interesting. Despite the publication in June 2000 of the pivotal NEJM paper highlighting the cardiovascular risk posed by Vioxx, the FDA took no action.

    In September 2001, the FDA said in a letter to Merck that the company's assertion that Vioxx was safe for the heart was “simply incomprehensible.” Still it took no action. The following year, the warning label on the Vioxx packets was finally changed to alert patients to cardiovascular risks.

    Seen squirming under questioning by Congressional investigators in the documentary, Steven Galson, the director of the FDA's Center for Drug Evaluation and Research, agreed that even this modest label had taken “longer than it should have.” And his explanation for the delay? “We were trying to work out exactly what was acceptable to both sides.”

    Yes, you read that correctly. The issue of a mass-market medicine for a non life-threatening disease raising the risk of heart attack by 500% in millions of people was not a public health emergency in the FDA's eyes, but simply a source of 18 months' polite negotiation—with the protection of the manufacturer's commercial interests evidently high on the agenda.

    Almost as bad, the documentary showed how one of the chief whistleblowers at the FDA, David Graham of the FDA's Office of Drug Safety, needed Congressional protection in order to keep his job after threats and abuse culminated in his sacking from the agency.

    Galson has retained his job of head of the Office of New Drugs at the FDA. The FDA's Commissioner, Lester Crawford, who also came under fire for his role in the Vioxx scandal, quit the agency and has since taken up a job lobbying on behalf of the pharmaceutical industry.

    Cynics would say this is why FDA executives make life easy for big pharma—they're thinking of a cushy six-figure salary there in the not too distance future.

    Some of the campaigning elements of the US Congress have the bit between their teeth now—one of the key movers, Democrat Henry Waxman, is leading the attack on the FDA over its handling of rosiglitazone, the GSK diabetes treatment that is also under suspicion for raising patients' heart attack risk.

    And there's little sign of the press relenting. It would appear that even Washington DC's mighty pharmaceutical lobbying machine will have its work cut out to prevent some major changes to drug regulation.

    Given the depressing similarities between US and European drug regulation—the reliance on industry funding, the dearth of post-marketing surveillance, etc—perhaps it's time for our policymakers and journalists to start asking a few more questions this side of the Pond.