Healthy Skepticism Library item: 4542
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: media release
McConnell M.
An open letter to Healthy Skepticism:
2006 May 3
Keywords:
Vioxx Topol
Notes:
Ralph Faggotter’s Comments:
“ It is we the prescribers who are charged with the high calling of our patients’ welfare. “
The Vioxx blame-game means hundreds of journalists, lawyers and doctors running around pointing accusing fingers at one another. Where does the buck stop?
Mark McConnell suggests that, it is the prescriber who writes the prescription who must shoulder the final responsibility.
Full text:
An open letter to Healthy Skepticism:
With respect to the recent withdrawal of Vioxx, Dr. Topol suggests that Merck and the FDA failed the Public Health. (1)
Did Merck fail? Eighty million prescriptions and annual of sales of $2.5 billion for a drug similar to generic over-the-counter analgesics would seem to qualify as success. Do we believe that protecting the Public Health is the duty of the pharmaceutical industry? “A drug company’s primary interest is to maximize sales of its product.” (2) Merck is not evil; they simply are a business and I should not expect them to guard the Public Health.
Did the FDA fail? I suppose we can ask them to mandate more studies, as Dr. Topol suggests, but the FDA published data regarding overall serious adverse events (SAEs) in 2001 (3,4). Information about cardiac concerns with these drugs was public record and readily available.I would suggest the perhaps unpopular perspective that it is we who wrote the prescriptions for Vioxx and those health professionals that recommended we use Vioxx for our patients who have failed. It is clear that neither Merck nor the FDA has the power to prescribe this medication for our patients; we prescribers are the only ones who can help or harm our patients with prescription medication. I believe we failed our patients and “the Public Health”. And I believe this happened because, though we are well intentioned, we may be listening to the wrong voices.
Perhaps we prescribers should avoid biased information such as information from the pharmaceutical industry. This includes information from pharmaceutical sales representatives (see www.nofreelunch.org) and information from industry sponsored CME. Dr. Topol refers to this as “countless continuing medical ‘education’ symposiums”. I suspect he puts “education” in quotes to point out what past editors of this prestigious journal have noted. Drs. Marcia Angell and Arnold Relman have written extensively on how we need to take back the education process…take it away from industry. I suspect that Industry sponsored marketing in the form of numerous conferences has led to the over-prescribing of Vioxx. In addition, we should be aware of the effort by Industry to identify “opinion leaders”…expert physicians who act as “consultants” to industry and present “education” at our community and teaching hospitals. Is this information the best we can get? I don’t think so. I would suggest that we “just say no” to any and all industry sponsored information. I think we can do better.
We should seek out balanced information. This may seem to be difficult but there are resources now that make this quite easy such as:
a) The BMJ’s Clinical Evidence: www.clinicalevidence.com
b) Healthy Skepticism: www.healthyskepticism.org and
c) Therapeutic Initiative at www.ti.ubc.ca
Specifically, in the Nov/Dec/Jan 2001-02 Therapeutics Initiative newsletter (#43) the authors present information on Vioxx and COX-2 inhibitors that, if heeded, would have prevented the recent “failure” Dr. Topol describes.
It is we the prescribers who are charged with the high calling of our patients’ welfare. It is we, and we alone, who prescribe. The failure is ours. Future failures can be prevented if we use the resources available to help us prescribe wisely.
1. Topol. E. Failing the Public Health – Rofecoxib, Merck, and the FDA. N Engl J Med, 351: 1707-9
2. Studdert, D.M., Mello, J.D., Brennan, T.A., Financial Conflicts of Interest in Physicians’ Relationships with the Pharmaceutical Industry – Self-Regulation in the Shadow of Federal Prosecution. N Engl J Med, 351: 1891-1900
3. US Food and Drug Administration. Celebrex capsules (celecoxib) NDA 20-998/S-009-Medical Officer Review 2000. Available at: http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1.htm.
4. FDA Panel finds no safety benefit for Celebrex. Scrip World Pharm News. February 9, 2001; No. 2626:19.
Mark McConnell, MD
2621 Van Loon Rd.
LaCrosse, WI 54601
April 28, 2006
