New Proposal to Examine Drug Safety
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Yesterday, the New York Times reported that a new plan to monitor the safety of drugs could identify a particular drug's risks long before they might have otherwise been discovered. The study that devised this plan was published Monday in the Archives of Internal Medicine.
The authors propose a system to examine widely prescribed drugs through safety analyses that would pool data as they emerge from various clinical trials of a medication and aggregate the information for a fuller picture of a drug’s harms and benefits.
This database would be constantly updated as the results of studies were published. This could allow a "real-time" analysis of the various risks and benefits associated with certain drugs.
Dr. Joseph Ross is the lead author of the study and proposed this plan as a new model for post-market surveillance of drugs. Dr. Ross's study used Vioxx as an example and determined that Merck could have discovered the cardiovascular risks of Vioxx many years before it took the drug off the market in 2004.
Merck questioned the methods used by Dr. Ross and his colleagues in the study, stating that the categories used were too broad and included patients who suffered heart attacks after they had stopped taking Vioxx.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, stated that the type of cumulative analysis proposed by Dr. Ross's study requires an act of Congress. Although the FDA has increased its efforts to ensure drug safety in the past few years, critics call for Congress to grant the FDA more power and resources in order to provide detailed information to patients and doctors.
“There is this kind of dogma in medicine that you shouldn’t use any drug for the first seven years after it’s released, because it takes that long to figure out its harms and benefits,” said Dr. Michael Steinman, an assistant professor of medicine at the medical school of the University of California, San Francisco.
While there are many proponents of the study and its potential to identify drug dangers even faster, some say the number of drugs on the market today would make it nearly impossible, and perhaps too expensive, to cumulatively track every single one of them.
For more information on the FDA and prescription drugs, click here.
To read the study, click here.