Friday, April 18, 2008

The FDA Should Allow Peer-Reviewed Journal Republication As a Promotional Tool

The Food and Drug Administration has been considering a proposal to let drug makers use reprints of journal articles in promoting drugs for so-called off-label uses the FDA itself has not approved. The FDA would require the all publications circulated would have to be republished from a peer-reviewed medical journal. For patients in all groups across the US this plan offers the opportunity to receive therapies that are often delivered in our finest research institutions. The impact in the fields of oncology, psychiatry and neurology could be profound.

The Healing Project not only supports this initiative but also that of Abigail’s Alliance that seeks easier access to experimental treatments for people suffering from life threatening diseases. It is time to grow-up. Many things can injure us including food, vitamins, supplements etc. The FDA, CDC, and NIH are grossly under-funded and treatments that would benefit many patients are left catching dust because of the hostile regulatory environment and penurious insurance company gate keepers.

Nonetheless, the opponents of this proposal rightly point out that bad actors in the marketing departments of pharmaceuticals companies could game the system. Ghostwritten articles and manufactured research could be used to promote the inappropriate use of compounds. Regrettably, the industry’s hands are dirty as demonstrated by the recent admission that Merck shaped an article published in JAMA. The Healing Project has enormous respect for the researchers within the pharmaceutical industry but marketing has far too much to say. In order to ensure that this initiative is adopted, the industry should volunteer to accept a harsh penalty for fabricating articles and or manipulating research utilized to promote off-label prescriptions. The owner of the compound would forfeit one or more years of gross profit attributable to the agent. Further, the authors attached to the article should be deemed ineligible for any federal or state funding for a period of no less than five years. With penalties in place, it is quite likely the research promoted would be clean and patients would be eligible for medications they often desperately require.

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