[e-drug] Should drug companies test their own drugs? (4)

["Peter Mansfield" <peter.mansfield@adelaide.edu.au>]

E-DRUG: Should drug companies test their own drugs? (4)
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Leo,

It is possible to have contact eczema or acute renal failure without taking
a drug. 

Vioxx should not have been approved until there was adequate evidence that
it was no worse than other NSAIDs for at least one group of patients. The
VIGOR trial data showed equal efficacy and an overall increased rate of
serious adverse events so Vioxx should have been withdrawn then. However
because of industry control and groupthink the key findings were not given
the attention they deserved. Refusal to approve Vioxx until there was
adequate evidence that it was no worse would have provided an incentive for
studies in people at high risk of GI adverse effects and low risk of
cardiovascular disease for whom Vioxx may be superior. 

I don't understand your distinction between the two types of adverse event.
I think there is a continuum between adverse events that are easy to link to a drug because they are clear cut, immediate and/or unlikely to have another cause at one end of a spectrum with events at the other end of the spectrum that are subtle, delayed and/or could have another cause so it is difficult to distinguish the signal from the noise.

A more important point is that publicly funded and accountable drug
regulation is not enough. We also need publicly funded and accountable
research, manufacturing, education and promotion. Healthy Skepticism's
proposals for redesigning the incentives for those 4 activities are
summarised in my rapid response at:
http://bmj.bmjjournals.com/cgi/eletters/333/7558/0-f

Even that is not enough. Healthy Skepticism's full reform agenda includes:

1. improve decision making by improving education for health professionals
and the public
2. redesign incentives for drug companies 
3. redesign incentives for health professionals 
4. improve regulation of drug companies 
5. improve regulation of health professionals

See:
Mansfield P, Rogers W, Jureidini J. Submission from Healthy Skepticism re
RACP Ethical Guidelines. Healthy Skepticism International News 2005 Sep;
23(9)1 www.healthyskepticism.org/news/issue.php?id=15

regards,

Peter

Dr Peter R Mansfield
GP
Director, Healthy Skepticism Inc. Countering misleading drug promotion.
www.healthyskepticism.org
peter@healthyskepticism.org
Research Fellow, Discipline of General Practice, University of Adelaide.
www.adelaide.edu.au/directory/peter.mansfield
peter.mansfield@adelaide.edu.au