Don't blame it all on the bogey
BMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39244.680880.59 (Published 14 June 2007) Cite this as: BMJ 2007;334:1250
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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: No competing interests
Drug safety
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: No competing interests