“FDA approves Gemzar for ovarian cancer despite its lack of efficacy”

May 13, 2007
I expect most of the people who read my posts are not terribly interested in hedge funds, the SEC, the politics of the FDA, why certain drug treatments get approved or don’t, especially for intractable/incurable medical conditions.  I am just trying to understand these issues myself.  From the articles I have found and posted today the process appears to be quite arbitrary, political, and not necessarily guided by ’science.’  
And then there are the lobbyists who are associated with hedge funds and the arms of the U.S. government.  One of the interesting things I saw today was that Frank Fahrenkopf, the CEO and President of the American Gaming Association, was quoted about hedge funds but didn’t declare that he was CEO and President of the American Gambing Association. 
This is his quote:
 "Particular industries reach a point where they get big enough that they realize that Congress can, intentionally or unintentionally, harm them through taxation or regulation," said Frank Fahrenkopf, a prominent Washington figure and lobbyist who headed the Republican National Committee in the 1980s."  (see the article "Hedge Funds Ramp Up Washington Activism" at
http://biz.yahoo.com/ap/070511/hedge_funds_washington.html?.v=2).
And yet the rhetoric is that the ‘market forces’ are fair - huh! 
I expect I will keep on doing some reading and research in this area over the next couple of weeks and will post here any information I find relevant - if not for my friends, I know that there will be others now and in the future that want to learn more about this issue of complicity between government agencies such as the FDA and the SEC kowtowing to hedge funds and their lobbyists. 
from http://findarticles.com/p/articles/mi_m0ISW/is_280/ai_n16850472
Townsend Letter for Doctors and Patients,  Nov, 2006  by Ralph W. Moss

This summer, the Food and Drug Administration (FDA) took the rare step of overruling one of its own advisory panels and approved the drug Gemzar (known generically as gemcitabine) for the treatment of recurrent ovarian cancer. Earlier this year, the prestigious Oncologic Drugs Advisory Committee (ODAC) strongly recommended against approval of the drug for this indication. (1) But the FDA–under the acting directorship of Andrew C. von Eschenbach, MD–approved Gemzar in combination with carboplatin for women whose disease had relapsed six months or more after their initial therapy.

In the past, FDA decisi on-makers have generally followed the advice of their advisory panels, although they are not legally bound to do so. In March, a spokesperson for Eli Lilly, the manufacturer of Gemzar, said that the company was "really disappointed" with the panel’s decision. So what happened behind the scenes between March’s disappointment and July’s triumphant announcement of approval? Lilly spokesman Dr. Gregory Clarke stated that the company had provided the regulatory agency with additional information. "This is a situation where we were able to provide the FDA with additional analysis of the data that may have given a little more insight on the benefits," he said. Meanwhile, FDA officials have refused to comment on the controversial decision. It seems decidedly odd that this "additional analysis" was provided directly to FDA leaders and not to the expert panel or the general public.

This is also the first time that the FDA has approved an ovarian cancer drug based upon progression-free survival (PFS), rather than on the basis of an improvement in overall survival (OS). The difference between these two measures is not trivial. Although it sounds like a highly desirable outcome, "progression-free survival" merely represents an interval of variable length between the administration of treatment and the point at which the cancer inexorably starts to advance again. Such delayed tumor growth does not necessarily equate to an extension of the patient’s lifespan. Indeed, tumors that are arrested temporarily can then advance more rapidly once they begin growing again, and patients may actually live no longer than they would if they had not received the treatment.

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