Flooding the Safety Zone

  • by: |
  • 03/28/2008
The FDA is ramping up it's effort to monitor the safety of drugs through its Early Alert and REMS program. It could be that the constant release of information on safety will do two things:

First neutralize the fear mongering and it's impact of people like Steve Nissen (more on him later) by getting ahead of the curve early and often. Second, get people and doctors to think more generally about the risks and benefits of medicines as well as their proper use. Finally, maybe it will prod companies and insurers to offer genetic tests to increase safer and more tailored dosing and drug selection right off the bat...

Genomas for instance is developing a genetic test to predict and compare an individual's risk of getting muscle pain among atorvastatin, simvastatin and rosuvastatin. I have used the protoype for my statin selection. http://www.genomas.net

I was pretty critical about the Early Alert program at first, regarding it as not being science based. But maybe (is it possible?) I was wrong. I think that flooding the safety zone with information is useful. It would be great as part of the Alerts to note that incidence of safety problems as a percentage of total scrips to put things into perspective. Along those lines, we encourage everyone who cares about the safety and impact of their meds to sign up for Iguard.org, a patient community that shares information about the benefits and side effects of their drugs. You can enroll at www.iguard.org

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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