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.

The FDA and Access to Developmental Drugs: Is Undo Caution Costing Lives?

The Healing Project wishes to call attention to a commentary piece published in the Wall Street Journal of August 14th authored by RONALD L. TROWBRIDGE and STEVEN WALKER volunteers for Abilgail’s Alliance for Better Access to Developmental Drugs.

The commentary highlights that a 12 pharmaceutical compounds that were not available for chronically and end-of-life patients in the last six years that were later approved by FDA. The delay in availability has shortened 1MM lives.

Further, the FDA has used approvable letters to delay the introduction of numerous drugs, driving up the costs of production and delaying the time-to-market.

With due respect to the FDA, when people are dying or so debilitated that life is abject, common sense would demand some degree of latitude. The safety at all costs mentality is childish and dangerous. More people die of food poisoning every year than die from ethical pharmaceuticals. While the agency and the Congress will point its finger at Vioxx, it should be noted for patients that cannot tolerate NSAIDs such Aspirin and Ibuprofen; COX-2 inhibitors make life tolerable.

If we confine the argument to science, science would argue given a known outcome (death/debilitation) and informed consent patients (your ingestion of this drug is experimental), should have the opportunity to purchase drugs that may offer them some potential benefit. Furthermore, the FDA should be forbidden to use data from these dying and debilitated patients to negatively impact the registration application of a given pharmaceutical. No company would elect to sell any compound in development for fear of the caprice of the agency’s bureaucrats.

Abigail’s Alliance continues to fight court battles and support legislation to open access to promising pharmaceuticals, and The Healing Project supports them.

If you would like to help write a letter, or drop an e-mail or call your Representative and/or Senator and demand that legislation be passed to open access to developmental drugs.