Real Time Reporting on Drug Effects-Reality not Rhetoric

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  • 04/18/2008
Robert Goldberg

For those who think that real time reporting of how drugs work in people will lead to a mass of lawsuits, one size fits all drug switching and drug withdrawals think again. From a WSJ article on a Wellpoint-FDA drug data sharing program:

"Contrary to the meta-analysis, WellPoint's initial findings didn't necessarily indicate a higher heart-attack risk linked to Avandia than to Actos and other diabetes medications. Now the company is broadening the data search to examine the safety question further. (The insurer says the study wasn't sponsored by Glaxo or another drug company.)"

Any comment Dr. Nissen or are you too busy offering protection to companies with what will be yet another outdated approach to drug safety?

And HMOs will find it harder to shove patients into drug silos...so much for comparative effectiveness....

"Kaiser also has performed its own safety and efficacy tests on FDA-approved drugs before placing them on its formulary. Within the past six months, for example, for instance, it studied whether a particular generic version of the blood-thinner warfarin was as safe and effective as other versions. David Campen, medical director of Kaiser's Northern California pharmacy operations, said it took the precaution before price negotiations with the generic's maker, given that even slight dosing changes in warfarin can cause harsh side effects."

Wait till genetic tests are broadly available.

Reality bites, especially when you are trying to use one size fits all studies to squeeze savings out of health care....

http://online.wsj.com/article/SB120822459568214991.html?mod=health_home_stories


PS...The FDA should be applauded for leading the way in this effort.

Posted by Robert Goldberg on April 15, 2008 12:58 PM
CMPI

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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