FDA decision on cancer drug means life or death for patients 

Today is D-Day for breast cancer patients. The Food and Drug Administration is expected to announce whether it will rescind approval of Avastin for the treatment of late-stage breast cancer.

If the FDA denies Avastin, the agency will be allowing politics to trump good medicine.

Avastin is a cutting-edge drug that staves off cancer by cutting off blood supply to tumors. For thousands of women, it is a miracle treatment.

In 2008, the FDA approved Avastin for women with advanced breast cancer based on its ability to stop tumor growth, a measure called “progression-free survival.”

While an increase in overall survival has been considered the gold standard for cancer drugs, progression-free survival has been used as a benchmark for longer and better quality of life.

Yet when results of additional studies this summer concluded that Avastin does not extend life on average, an FDA advisory committee suddenly decided the drug should be measured by overall median survival, not progression-free survival.

Why would it change the rules of the game at halftime?

Avastin opponents — who have long regarded the drug as a symbol of corporate greed — have lobbied for median survival as the key standard. They know that the perception of Avastin’s effectiveness would be harmed by applying that standard and inspire the media to raise harsh questions about the drug’s cost.

Indeed, many interest groups, including the Center for Science in the Public Interest and the National Breast Cancer Coalition, pushed for a higher standard for Avastin. CSPI Project Director Merrill Goozner has coldly noted that “an FDA decision to pull back its specific approval for the breast cancer indication would allow insurers — including Medicare and Medicaid — to reject paying for Avastin, whose annual costs can reach $100,000 a year for those who live that long.”

The one-size-fits-all approach of median survival ignores the heterogeneity of treatment response and tumor progression that is the hallmark of breast cancer treatment.

If the FDA does in fact revoke approval, the move will mark a shift away from applying insights about biological variations shaping cancer progression in favor of an approach that sensationalizes a product’s price and dangers and uses measures that marginalize benefits.

Treatment decisions need to be based on the best medical science, not tabloid medicine.

Dr. Robert Goldberg is a co-founder and vice president of the Center for Medicine in the Public Interest. He is the author of the forthcoming book “Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science For Fear and Profit” (Kaplan, December 2010).


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