- 1Department
of Medicine; Professor of Medicine and Epidemiology (McGill) McGill
University Health Centre, Royal Victoria Hospital, 1001 Decarie Blvd,
Montreal, QC, CANADA H4A 3J1,. james.brophy@mcgill.ca.
Abstract
I
read with interest Mark Wilson's recent article, "The New England
Journal of Medicine: commercial conflict of interest and revisiting the
Vioxx scandal". I believe this is an important contribution that
underlines the aphorism "Those who don't know history are doomed to
repeat it." As Vioxx is a seminal example, it is important to place it
in its proper context, examining if this malfeasance extends beyond the
VIGOR study. While the epicentre of this conflict of interest surely
begins with the sponsor, I believe the following essay demonstrates that
this wave of egregiously unethical behaviour can exist and be
propagated only with the complicity of academic investigators, medical
journals, a flawed peer-review system and an uncritical medical
readership. Perhaps the most troubling is that the factors that
coalesced into the Vioxx scandal are, if anything, more ubiquitous
today, mandating increased vigilance to decrease the probability of
"getting fooled" again.
The New England Journal of Medicine: commercial conflict of interest and revisiting the Vioxx scandal.
- 1Health Research Associates, Guelph, Ontario, N1G 3S4, Canada,. markwilson1920@yahoo.com.
Abstract
At a recent cardiology conference in New Delhi, the cardiologist Deepak Natarajan raised the concern that commercial conflicts of interest (COIs) were corrupting medical journals. Natarajan cited "manipulated" publications in The New England Journal of Medicine
(NEJM) as one example to support his view. His comments were met with
silence and an air of indignation. Natarajan's medical colleagues were
stunned, disbelieving, and then, angry.
The Vioxx pharmaceutical scandal: Peterson v Merke Sharpe & Dohme (Aust) Pty Ltd (2010) 184 FCR 1.
- 1The Australian National University, College of Law and Medical School. Fauncet@law.anu.edu.au
Abstract
In
early March 2010, Federal Court Justice Jessup in Peterson v Merke
Sharpe & Dohme (Aust) Pty Ltd (2010) 184 FCR 1 ruled that Merke
Sharpe & Dohme Pty Ltd had produced a defective product contrary to
the Trade Practices Act 1974 (Cth), the anti-arthritic drug Vioxx.
Promoted as relieving arthritic pain without the side effect of gastric
ulceration, the drug also doubled the risk of heart attack in those
prescribed it. The court also heard that the manufacturing company had
engaged in misleading practices to promote the prescription and usage of
Vioxx,
including "fake" journals and guidelines to "drug reps" that minimised
the adverse cardiovascular risks. The manufacturer had already settled a
class action in the United States for more than US$7 billion for those
harmed by the drug but this was the first such case to be decided in
Australia. The court awarded the applicant, Graeme Peterson, A$300,000
in damages. This column examines this judgment and analyses evidence
there presented that Merck may have misled the scientific community, the
medical profession and Australia's drug regulation system to get Vioxx
on the market and keep it there. It considers whether the case reveals
the need for more rigorous post-marketing surveillance and other changes
to Australia's drug regulatory system, including a replacement of
self-regulation in pharmaceutical promotion with a United States-style
system of rewarded informant-led criminal penalties and civil damages
claims.
