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Monday, March 03, 2008


I believe that Dr. Moss has a very valid point. It isn't patient care that drives the FDA, it is $$$.


On Friday, Feb. 22, 2008, top administrators of the Food and Drug Administration (FDA) approved the drug Avastin for the treatment of advanced breast cancer. Avastin, which has already been approved for colon and lung cancer, is controversial because it has never been shown to extend overall survival (OS) in breast cancer patients. It has been shown to improve disease-free survival (DFS) by as much as 5.5 months, but disease-free survival is not by any means the same thing as overall survival. A patient receiving Avastin may have a 5.5 month improvement in disease-free survival yet still die at approximately the same time as someone who did not receive the drug.

Genentech, the manufacturer of Avastin, had sought approval for the use of Avastin in breast cancer as part of wider industry strategy called "label expansion," which essentially means squeezing new revenue out of existing drugs. With this latest FDA approval, Genentech may reap an additional $1.3 billion a year out of Avastin. The drug has been selling for off-label use in breast cancer at $100,000 per year.

In giving approval, FDA's top officials overturned the Dec., 2007 recommendation of their Oncology Drug Advisory Committee (ODAC), something that is rarely done. The FDA also acted over the objections of some prominent advocates in this field, including Barbara Brenner of Breast Cancer Action and Fran Visco of National Breast Cancer Coalition, both of whom argued forcefully against approval.

This decision was approved by FDA commissioner, Andrew von Eschenbach, MD, and Richard Pazdur, MD, director of the agency's Office of Oncology Drugs. For von Eschenbach, it is the latest in a string of decisions that strongly favor the interests of industry over those of consumers. Von Eschenbach has shown poor judgment in the past. When he was director of the National Cancer Institute (NCI) he was notorious for claiming that his agency could eradicate cancer by the year 2015. In fact, no significant progress was ever made towards this goal during his tenure and, when he moved to FDA, he quietly dropped all such claims. Now, as FDA commissioner, von Eschenbach has opened the gates even wider to Big Pharma, while keeping a tight leash on treatments emerging from the field of complementary and alternative medicine (CAM).

According to the Pharmalot Web site, a site devoted to pharmaceutical industry news and analysis, "the FDA's decision may now open the door for other cancer meds to be approved if studies find the meds can shrink tumors, although some docs worry patients may not really benefit."

Kay Dickersin, PhD, director of the Center for Clinical Trials at Johns Hopkins University, is quoted at the site as follows:

"If FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint."

But perhaps the most trenchant critique came from Barbara Brenner of Breast Cancer Action. She recently wrote FDA leaders that any new drug approval for treatment should meet at least one of the following standards:

* Extend the life of the patient, i.e., improve overall survival (OS), and/or
* Improve the patient's quality of life, and/or
* Cost less than therapies already available

"Standards short of these," she said, "put the interests of drug companies before those of patients and undermine the FDA's mission." The FDA's decision on Avastin, however, reflects the fact that "the agency's standards are dangerously different from these."

Upon announcement of the news, Genentech's stock regained the $10 billion it lost in December when the ODAC recommended against approval. After this initial setback, Genentech courted doctors and advocates, and lobbied very hard to ensure that in spite of the unfavorable ODAC decision the drug would nevertheless be granted approval. A day before the FDA's decision, the editorial board of the Wall Street Journal issued a statement declaring the impending Avastin decision not just a scientific pronouncement but "a moral test for the FDA." It called the ODAC's recommendation to block Avastin "incredible," and referred to the FDA's rules as "obsolete" and "anti-modern." (Feb. 21, 2008).

I would agree that much about the FDA is outmoded and in need of reform, but a determination to hold the line against unproven drugs is surely part of the solution, not the main problem.

Unlevel Playing Field

What galls me, and probably also many of my readers, is that FDA remains hyper-vigilant against a variety of CAM treatments, which usually originate from enterprising small companies both here and abroad. Most individuals with new ideas for cancer therapy eventually give up their attempts to enter the American market in the face of FDA demands for a level of proof that is simply impossible for small companies to achieve. Yet the same agency then gives a free pass to an $80.7 billion company, Genentech, Inc., for a drug that has yet to be proven to do anything significant for breast cancer patients. This creates a strong impression that FDA's approval is for sale, and that in the end it is all about money, not science.

FDA has once again significantly lowered its standards for drug approval. If it proposed doing so across the board, including taking a more even-handed approach to CAM treatment, that would be the basis for an interesting discussion. But what FDA is doing is permitting a lower standard for the expensive products of Big Pharma, while remaining wary of all non-toxic or non-patentable agents. So, whatever happened to the level playing field that a former director of the National Institutes of Health (NIH) promised the CAM movement back in 1992? Gone with the wind.

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