Pharmas Market with Mike Huckman

FDA, DNDN, SNY And Cancer Drugs: Your Emails


I received a lot of comment on this week's post about the editorial in USA Today about the Food and Drug Administration improving patient access to potentially lifesaving or life-extending experimental drugs and the counterpoint op-ed by FDA commissioner Dr. Andrew von Eschenbach.

Lori Gluth writes:
"Von E’s commentary appeared to me to be a lame CYA."

Ray Vestal had a similar take:
"Von E is starting to feel the heat....Von E. had no choice but to respond to the USA today piece and now it shall be interesting to see he responds to the ralley at his front door!" (He's referring to the Dendreon Provenge protest outside FDA headquarters which I blogged about yesterday.)

Terry Rush says:
"The FDA is dysfunctional and needs Congress to step in and investigate."

And a reader who didn't attach a name, but did indicate the email is coming from Los Gatos, California writes: "There is no humane nor logical reason to deny patients drugs which were shown to be safe and are promising though not 'proven'.Alas FDA seems totally incompetent, incapable and impotent to do it the right, humane way."

And, as always, the post about the above-mentioned Provenge protest generated a few replies.

Nick Stavriotis says:
"There’s not only a growing frustration with the agency over the issue of approving experimental meds, particularly for cancer…but also over the lack of transparency when the FDA overrules an FDA appointed advisory panel in a positive finding in a terminal illness. As you know, the FDA’s move to overrule its Provenge panel was unprecedented."

Acutally, the FDA's "move to overrule" the Provenge advisory committee is not unprecedented. The agency usually, but not always, follows the advice or recommendations of its outside expert panels. In fact, there've been at least a few other examples in recent months.

Dr. Martin C. Carr sent a long email in defense of Provenge using its generic or scientific name, Sipuleucel-T and the same for Sanofi-Aventis' Taxotere (docetaxel). He doesn't reveal his specialty, but says that he graduated from the NYU School of Medicine in 1959. Here's an excerpt: "...the presentation at (the) Advisory Committee Meeting on 3/29/2007 provide compelling evidence that there is a subset of advanced prostatic cancer patients who are benefiting from the immunotherapeutic effects of Sipuleucel-T . The survival rates at 36 months in this subset are more than double that of the placebo group. Even more impressive is the survival when treatment with Sipuleucel-T was associated with docetaxel. The survival rates reaching 50% at 36 months compared to less than one-half that of the docetaxel only group. These studies were blinded, random and placebo controlled. The effects are real. At the very least, Sipuleucel-T should be approved to be used with docetaxel....To do anything else would be depriving the afflicted men of a chance for further survival measured in years rather than months and consigning them to an untimely morbidity."

And finally Charles Harris asks why the Department of Defense has a Prostate Cancer Research Program. In my previous blog I wrote that the DOD is putting on a prostate cancer conference in Atlanta next month. Mr. Harris writes: "I was surprised to see that the Dept. of Defense had a Prostate Cancer Research Project and forum. Why would that department vs. another government Health organization sponsor it? Is it because there are more men in the military?"

Here's the answer from the a DOD Web site: "Cancer of the prostate is the most commonly diagnosed cancer in men. In 2006, approximately 234,460 men in the United States will be diagnosed with prostate cancer, and approximately 27,350 will die from the disease. The direct immediate health care costs of this disease to the Military Health System exceeded $42 million (M) for fiscal year 2004 (FY04)"

You can read much more about the program by clicking right here.

Questions?  Comments?