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

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4 July 2007

Donald Light in his rapid response to my article "Don't blame it all on the bogey" (BMJ 2007;334:1250-1) suggests that the risk presented by Vioxx was not clear cut in June 2000. But did a potential danger of that magnitude need to be proved beyond doubt before the FDA took action?

In addition, Mr Light conveniently ignores the next line in the piece noting how the FDA stated in a letter to Merck in September 2001 that the company’s assertion that Vioxx was safe for the heart was “simply incomprehensible”. There was still no label change that year.

My article and the film that it prompted both point out that drug companies are calling the shots. Surely, then, it’s not unreasonable to suggest agencies charged with regulating these companies are failing in their primary responsibility of protecting the public?

As Mr Light says in his rapid response: “…the industry has shaped the rules of the regulators, funded their operations, and lobbied them constantly in a classic pattern of regulatory capture… the regulator established to protect the public's safety must review its decisions about unsafe drugs with the company that is vigorously selling them. Companies routinely take months to negotiate a proposed warning and water down or prevent the documented risks from being added to the label".

Hence Mr Light, in his roundabout, endearingly unjournalistic way, merely reiterates what I’ve said: that the regulators aren’t doing their job.

It might be argued that this is really a matter of semantics: a chicken or egg debate over where culpability begins. But I don’t think it is. The industry’s primary responsibility is protecting its shareholders’ pockets, not the health of the public; that duty lies with the regulatory bodies – although sometimes you wouldn’t know it.

So fund these agencies more generously and give them more teeth. In that Mr Light and I are agreed.

Michael Day

Competing interests: None declared

Competing interests: None declared

Michael Day, freelance journalist

London SE17

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A loyal reader of the BMJ recently bemoaned that his favorite medical journal was deteriorating into being journalistic, and he handed me Michael Day's recent essay1 on how the British press should stop beating up on drug companies for unsafe drugs like Vioxx or Seroxat and go after the regulators like the Medicines and healthcare products Regulatory Agency (MHRA) the way the American press goes after the FDA. I can see why my friend is worried.

Was this essay reviewed by knowledgeable experts? It is riddled with misstatements and shallow thinking and should not take up precious space in the BMJ. Mr. Day makes out as if everyone knew by June 2000 that Vioxx increased users' risk of stroke or heart attack by 4-5 times but the regulators failed to withdraw it. I know this history well, and good people differed on whether this risk difference was due to the protective attributes of naproxen or the adverse effects of Vioxx. The MHRA reviewed the evidence immediately and compared it to results from other trials that did not show such risks. It continued to review further evidence in subsequent months and issued cautions and warnings. So did the FDA, roughly.

I agree with Mr. Day that both regulators, and EMEA, should have been more proactive; but Day leaves out two basic points. First, guarding the safety of patients would not be necessary if drug companies did not repeatedly show their willingness to market dangerous drugs and mislead doctors and patients about their risks. The past director of Merck told the Wall Street Journal that it had made blockbusters out of drugs with serious side effects before and it would do it again.2 Second, the industry has shaped the rules of the regulators, funded their operations, and lobbied them constantly in a classic pattern of regulatory capture. For example, the reason why the label change for Vioxx took "longer than it should have" and also reduced the FDA's serious warning to practically no warning is that drug companies made sure long ago that the rules would give them veto power over any label changes. Thus the regulator established to protect the public's safety must review its decisions about unsafe drugs with the company that is vigorously selling them. Companies routinely take months to negotiate a proposed warning and water down or prevent the documented risks from being added to the label. We find ourselves back to the bogeyman and the eagerness of governments to please it. Research by John Abraham and others provides good evidence that British and European patients are at increasing risk of serious adverse events from newly approved drugs and at greatly risk than American patients.3 4 What the press might focus on is Parliament and why it is unwilling to establish and fully fund a safety board with full power to protect the public.

D.W. Light, PhD Fellow Netherlands Institute for Advanced Study

References

1. Day M. Don't blame it all on the bogey. BMJ 2007;334:1250-51. 2. Mathews AW, Martinez B. Warning signs: e-mails suggest Merck knew Vioxx's dangers at early stage. Wall Street Journal 2004 (1 Nov);A1. 3. Abraham J. Risking public safety: experts, the medical profession and 'acceptable' drug injury. Health, Risk & Society 2005;7:379-95. 4. Abraham J, Davis C. A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy Social Science and Medicine 2005;61:881-92.

Competing interests: None declared

Competing interests: None declared

Donald W Light, Fellow

Netherlands Institute for Advanced Study, 2242 PR Wassenaar, NL

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