Last week, the Oncologic Drugs Advisory Committee (ODAC) of the Food and Drug Administration (FDA) voted 5-4 to recommend against approving the drug Avastin for first-line use in advanced breast cancer. In clinical trials to date, Avastin has not been shown to extend overall survival or to improve quality of life for women with metastatic breast cancer.

Traditionally, FDA has required that new drug approvals should only be granted on the basis of clear evidence of patient benefit. But lately the agency has lowered its standards and has begun to approve drugs based on clinical trials that use surrogate endpoints such as "disease-free interval" and "time to progression" instead of the much more clinically meaningful measure of overall survival. The main beneficiaries of this change in the standard of approval have been big pharmaceutical companies, not cancer patients.

The ODAC is mainly made up of cancer doctors, but does include a few non-physicians, at least one of whom was instrumental in the vote against approving Avastin.

"Absolutely it's a very painful reality that metastatic breast cancer is not curable," said Natalie Compagni Portis, a patient representative on the committee, who voted against approval. But, she added, "I don't think that means that we should just say, ‘Well, here, try this,' if there isn't meaningful data to support it." (New York Times, Dec. 6, 2007).

I congratulate ODAC for recommending against granting a new indication for a drug that has not been proven to work in this patient population. And I especially congratulate Breast Cancer Action, the San Francisco-based activist organization, which led the campaign to educate ODAC members and the public about this issue.

Readers should be aware, however, that this might not be the end of the story. ODAC, as its name implies, is only an advisory committee, and Genentech executives have indicated that they still hope to get around the ODAC decision.

According to the Times, Dr. Susan Desmond-Hellmann, Genentech's president for product development, said the company might ask the FDA for conditional approval on the promise of later providing survival data from two other clinical trials that are now under way (ibid.).

The final decision is now in the hands of Andrew von Eschenbach, M.D., the FDA commissioner, and his deputy, Dr. Richard Pazdur, director of the division of oncology drugs. They can still overrule ODAC's recommendation.

As a concerned citizen, you have a right to express your opinion on this matter. I am therefore calling on readers to send a brief email to Dr. von Eschenbach and Dr. Pazdur asking them to listen to their own advisory panel and not to approve the ineffective drug, Avastin, for advanced breast cancer.

Their email addresses are as follows:

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If enough of us write in, this will hopefully influence FDA to put the needs of cancer patients above those of the drug companies, and only to approve drugs that are of actual benefit to cancer patients.

--Ralph W. Moss, Ph.D.

Disclosure: Ralph Moss serves on the scientific advisory board of Breast Cancer Action.

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