An opinion piece written by Ronald Trowbridge and Steven Walker appeared today in the WSJ. The piece is centered on the recent decision of the full D.C. Circuit Court of Appeals that reversed its own smaller panel’s 2 to 1 decision to allow dying, terminal patient’s access to investigational drugs that have been found to be safe. (See my posts of August 7 and August 8 2007)

Mrs. Trowbridge and Walker describe the history and the rational of the case, which was filed, by the Abigail Alliance and the Washington Legal Foundation in 2003. The suit asked for better access to development drugs for terminal patients who were left with no treatment options.

Over the past 5 years, the Alliance has pushed for access to 12 exceptionally promising drugs, all of which were eventually approved by the FDA, but not after a significantly long wait that was measured in years. Mrs. Trowbridge and Walker estimate that the additional death rate resulting from these long and unnecessary waits is as high as 520,000 people!

The most recent drug that the Alliance has asked to be made available is the prostate cancer vaccine, Provenge. Based upon the most recent actions of the FDA we will now have to wait at least three more years before Provenge might become approved and available for us to use! This would allow an additional 81,000 men with prostate cancer to die without having Provenge available. This is just unacceptable.

One of the FDA’s answers to terminally ill people is that they can apply for special access to these investigational drugs. However, the American Cancer Society reported that 550,000 people die annually of some type of cancer. This translates to 4.8 million people from 1997 to 2005. Over the same period, the FDA has reported granting special individual access to only 650 people! Clearly, there is no value in the FDA’s special access program.

The Abigail Alliance has stated that they will appeal the Court of Appeals decision to the United States Supreme Court. They have stated that they agree with only one part of the majority’s decision, that Congress should pass the pending legislation called the Access Act. They want this legislation to be amended to the FDA reauthorization bill, which will be in front of Congress this September.

“This is a massive human tragedy, made even worse by the fact that it didn’t and doesn’t have to be this way. Looking at FDA automatons and the DC Circuit Court brings to mind T.S. Eliot’s question, “Where is the wisdom we have lost in knowledge?”

Joel T Nowak MA, MSW