Friday, October 30, 2009

New Study Highlights Need for Better Prescription Drug Labels.

Another example from GeriPal on how conflict of interest in drug regulation prevents consumers and doctors from fully assessing drug effectiveness. A new study in the New England Journal of Medicine argues for more extensive labeling on prescription drugs:

Schwartz and Woloshin note that when the FDA reviews a drug, expert reviewers consider a wealth of data about the benefits and side effects of the drug. They also raise questions, make judgments, and make statements about their degree of certainty that the benefits of the drug outweigh the risks. However, effectiveness and harm data that patients and their providers might want to see often do not make it to the drug label. Opinions of the expert reviewer, including their degree of uncertainty about the drug, would be of great interest but these virtually never make it to the label. This information is contained in FDA documents, but these voluminous documents are not practically accessible.

One commenter notes why the FDA does not have stricter requirements:

...drug labels are created in a process of negotiation between FDA and the drug manufacturer. There would clearly be less conflict of interest if the FDA would create the label without having to negotiate with industry about every word. Part of this would require greater funding of FDA to provide the human resources to take on such tasks. Unfortunately, previous attempts to use industry money to support FDA activities through the Prescription Drug User Fee Act (PDUFA) have resulted in their own conflicts of interest, whereby the FDA is beholden to industry for its funding. Thus, a better system needs to be devised to get the FDA the resources it needs to protect the public health while avoiding the conflicts of interest that have resulted in questionable decisions.

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