The Food and Drug Administration’s Deadly Policies

A devastating column in the Wall Street Journal calculates the death toll caused in part by the bureaucrats at the FDA. The paper-pushers refuse to let critically ill patients have access to experimental new drugs – even when those drugs already have cleared some clinical tests. In a free and just society, individuals would have the right to make those decisions:

The Alliance began pushing for access to investigational drugs for terminal patients after its founding in mid-2001 upon the death of Abigail Burroughs, who was denied an investigational drug (Erbitux) that an early trial showed might have helped her. She and her doctor were right, but she never got the drug. Over the past five years, the Alliance has pushed for access to 12 exceptionally promising investigational cancer drugs which have subsequently been approved by the FDA and now represent standard care. At the time we began our advocacy, each of the drugs had cleared at least preliminary Phase 1 testing, and in some cases more-advanced Phase 2 or Phase 3 trials. In other words, they obviously worked for some patients. …

In sum, these 12 drugs – had they been available to people denied entry to clinical trials – might have helped more than one million mothers, fathers, sons and daughters live longer, better lives. We have actually underestimated the number of “life-years” lost at more than 520,000, because we have not included other safe and effective uses of these drugs that the FDA has yet to approve. …

The American Cancer Society reports that some 550,000 cancer patients die annually, making the number of cancer deaths from 1997 to 2005 about 4.8 million. Over that same period, the FDA reports granting individual access to an investigational drug to not more than 650 people per year for all diseases and drugs – a pathetic, even cruel, pittance. A few thousand more patients managed to gain access by enrolling in relatively small clinical trials or exceedingly rare expanded access programs. The other 4.7 plus million cancer patients, not to mention millions more with other diseases, were abandoned to die, denied access to progress by their own FDA when they needed it most.