The NEJM has another open-access article about drug safety.
As usual, when they publish something on an open-access
basis, it is something of interest to the general public, pertaining to
health care policy.
This one describes specific instances of drug companies concealing
information from the FDA and the public.
Deception — Hiding the Evidence of Adverse Drug Effects
Volume 355:2169-2171 November 23, 2006 Number 21
Jerry Avorn, M.D.
September 30 is becoming a day of infamy for drug
safety. On that date in 2004, Merck announced that rofecoxib (Vioxx)
doubled the risk of myocardial infarction and stroke, and the company
withdrew the drug from the market after 5 years of use in more than 20
million patients. On September 30, 2006, a front-page article in the
New York Times reported that the Food and Drug Administration (FDA) had
issued a warning that the antifibrinolytic drug aprotinin, widely used
to reduce perioperative bleeding in patients undergoing cardiac
surgery, could cause renal failure, congestive heart failure, stroke,
…What put aprotinin on the front page on September 30, however, was
the revelation that its manufacturer, Bayer, had hired a private
contract research organization to perform its own large observational
study of postoperative complications in patients given the drug. The
analysis, completed in time for the FDA meeting, reached conclusions
similar to those of Mangano et al. It, too, adjusted for a wide variety
of clinical characteristics and showed that patients who received
aprotinin had higher mortality rates and substantially more renal
damage than those given other treatments. But neither Bayer
nor its contractor had provided the report to the FDA or even
acknowledged its existence before the meeting… [emphasis
So there was evidence of danger, evidence that was withheld from the
FDA. One might think that the fear of litigation would be
enough to prevent this kind of thing, but that clearly is not the case.
Others have posted on this, for example, Health
Care Renewal blog posted on 10/2/06, pointing out that it is
only the latest in a series of such incidents.
Some conclusions are obvious. I would caution against drawing
sweeping conclusions from this, but I would say that we clearly need
stronger legislation and regulation. Sparkgrass
points out that a great many medications carry black box warnings.
The point is not that medications can be dangerous.
Weighing risks and benefits is a routine part of medical
practice. Rather, the point is that physicians and patients
need access to all of the pertinent safety information.
The author of the NEJM article suggests that funding from drug safety
studies be drawn from the public sector. That would help, but
it would not be a guarantee of neutrality, nor would it be politically
Another suggestion is to have a major conference once per year, during
which drug safety information is reviewed. That would be
expensive, but perhaps trial lawyers could sponsor it. I’m
sure they would flock to such a thing, if it were open to the public.
Which is should be, at least via webcast.
I can’t help but mention, that I think financial reforms are in order.
Specifically, I would recommend a reassessment of the
practice of rewarding executives with stock options. Although
the idea of rewarding executives for performance sounds good, the
current system rewards not only performance, it rewards deception