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.