Opinion: Battling Cancer, and FDA Bureaucrats

For some patients with advanced breast cancer, 2011 began with a harrowing close call: A federal contractor announced that Medicare would no longer pay for women in several states to receive treatment with the drug Avastin.

This best-selling cancer medicine has clinically demonstrated its ability to give metastatic breast cancer patients more time -- more weeks or months in which the spread of their cancer is halted in its tracks.

Nevertheless, the Food and Drug Administration late last year revealed its intention to revoke approval of Avastin for these patients, arguing that the drug doesn't grant "enough" extra time, on average, to be worth it. The FDA gave assurances that the government would continue covering Avastin until drug-maker Genentech had exhausted its appeals. Still, anguished patients remained fearful they would lose one of the few hopes they have.


Fears Realized

Those fears were realized when Palmetto GBA -- the contractor that determines Medicare coverage in California, Hawaii, Nevada, Ohio, South Carolina and West Virginia -- said it would cease coverage after Jan. 29. New candidates for Avastin could, of course, still receive treatment with the drug -- just as long as they could pay its $8,000-per-month cost out of their own pocketbooks.

"This is the consequence we were concerned about," Elizabeth Thompson, president of the Susan G. Komen for the Cure advocacy group, told The New York Times. "We continue to urge third-party payers to fund Avastin for those women who benefit."

Fortunately, one day after the controversial news broke, Palmetto reversed course and said it would keep covering Avastin through the appeals process.

It was a temporary reprieve -- and also a troubling taste of the turmoil to come if the appeal before the FDA is unsuccessful, and government and private insurers seize the opportunity to stop funding a pricey treatment. That would set a deadly precedent, allowing a handful of government workers to dictate medical practices to millions of cancer patients.

Throughout the Avastin debate, scores of patients and their families have waged emotional appeals, pleading with the FDA to recognize that the extra weeks, months and in some cases even years Avastin may provide is absolutely "worth it" to them. These patients understand that each day in which their cancer doesn't progress means another day in which to celebrate a birthday, see their children graduate or get married, or simply enjoy life.

Avastin Works

Avastin works by shutting off the blood supply to cancerous tumors. Currently prescribed to about 17,500 breast cancer patients each year, Avastin also has unequivocal FDA approval to treat a number of other cancers and is the best-selling cancer drug worldwide.

One study of patients taking Avastin with chemotherapy found that such treatment delayed tumor growth a median of about 11 months -- five months longer than chemo alone. And some patients and their doctors report thriving for years on Avastin.

In reaching its decision, the FDA cited research that Avastin doesn't extend life for the "average" patient. But there is clear evidence that the drug can slow the spread of cancer while prolonging quality of life. And there's no one-size-fits-all treatment for breast cancer. Plus, by focusing only on average responses to Avastin, regulators overlooked "super-responders."

"I've been on Avastin nearly three years, am able to work full-time and lead an active life. I'm not alone" Shannon Morgan of Charlotte, N.C., wrote in USA Today. "Every drug has side effects. The FDA seems to forget that the primary side effect of Stage 4 cancer is death."

How could the FDA be wrong? Other expert panels have looked at the same data the FDA used on Avastin and reached the exact opposite conclusion. The European Medicines Agency, the EU equivalent to the FDA, recently reviewed the research and opted to approve Avastin for metastatic breast cancer.

Some Insurers Still Covering It

And despite the FDA's reticence, several key insurers have chosen to continue paying for Avastin use in breast cancer patients, including WellPoint, United Health Group, Aetna and Humana.

These insurers based their coverage decision on a recommendation from the National Comprehensive Cancer Network, a not-for-profit alliance of oncologists and pathologists.

It will be hard for many late-stage breast cancer patients to trust the FDA if the agency sticks by its decision to yank Avastin away. Already these women are battling a ravaging disease; they shouldn't have to spend precious time battling Washington bureaucrats as well.

Robert Goldberg is co-founder and vice president of the Center for Medicine in the Public Interest, a nonprofit that receives some funding from the pharmaceutical industry. He is also author of the new book, "Tabloid Medicine: How the Internet Is Being Used to Hijack Medical Science for Fear and Profit." (Kaplan).