NEJM Adds Nothing to the Drug Safety Discussion

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  • 10/09/2006
NEJM is running with two editorials on the heels of the IOM report on FDA's drug safety performance. One editorial is written by IOM task force member Bruce Psaty who has a history of dredging up data designed to scare without regard to accuracy. As one observer put it: Another breast cancer-scare story came during NBCAM at the expense of a widely prescribed class of drugs used to treat high blood pressure, called "calcium channel blockers" or CCBs. Published in the journal Cancer, this study reported post-menopausal women using CCBs had a 150 percent increased risk of breast cancer.

But the study was small and, as stated in a National Institutes of Health press release, "the findings do not establish a causal link between calcium channel blocker use and breast cancer." Moreover, the study conflicts with results of SYST-EUR, a recent long-term clinical trial of CCBs that did not reveal any increased cancer incidence.

The Cancer study is just the latest in a series of CCB-scares manufactured by Dr. Curt Furberg of Bowman Gray Medical School and oft-time cohort Dr. Bruce Psaty of the University of Washington. Their first scare linked CCBs with increased heart attack risk. But the evidence was so shoddy that Dr. Psaty was forced to apologize to colleagues at the American Society of Hypertension for launching a scare based on a single study with serious limitations.

Psaty is the lead author of the editorial in the NEJM calling for more clinical trials after market and a ban on DTC.

In any event, as I have said before, the IOM missed an opportunity to build support for effort to support more funding for programs that could truly make medicines safer without burdening drug development with pointless studies that will only make the process more costly and limit access to new medicines without regard to more precise risk/benefit profiles. As the FDA's Critical Path report noted nearly 4 years ago:

"Safety issues should be detected as early as possible, ways to distinguish potential from actual safety problems should be available..." Neither the IOM and NEJM talk about the use of biomarkers and the development of observational databases that could be mined to develop predictive models, the creation of more targeted medicines, the use of genetic tests, investment in data consortium. No. Just bigger, government funded studies that take years to organize, conduct and sort out. And meanwhile, patients and doctors are supposed to labor under onerous risk management programs that dole out drugs under the scrunity of government appointed risk finders who limit the expanded use of medicines.

Is there anyone in the media who will challenge or examine this conventional wisdom?

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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