THE FDA COULD WITHDRAW CANCER DRUG

The Wall Street Journal

  • SEPTEMBER 16, 2010

My Battle With Cancer and the FDA

By Friday regulators may withdraw the drug that’s keeping me alive.

Iam 67 years young and I’ve been battling breast cancer for 11 years. I’m alive today because of a drug called Avastin. But by Friday the FDA is expected to revoke its approval of the drug for use against breast cancer. I’m terribly frightened—and angry.

My story begins in 1999, when I lifted my arm and discovered a web of popping red veins. Doctors identified a tumor, and I was diagnosed with breast cancer. Chemotherapy worked for a bit, but then the tumor started growing again. So I had a mastectomy.

In 2002, the cancer returned—this time to my liver. That meant my cancer had metastasized. It was treatable but no longer curable.

Once again I underwent surgery, a liver resection. I was then put on the drugs Navelbine and Etoposide. At first, it seemed to work—my cancer went into remission. But three years later, the cancer came back. I now had four tumors in my liver and my outlook wasn’t very good. My doctor was blunt: “You’re in big trouble,” he told me.

Thankfully, a clinical trial had recently started and I was selected for a combination of Xeloda and Avastin. Xeloda is a chemotherapy pill that kills cancerous cells. Avastin cuts off blood-flow to tumors. Almost immediately two of my tumors disappeared. The duel-pronged approach appeared to be working.

Nearly three-and-a-half years have passed. Today, I’m not just living life; I’m enjoying it. While I get tired more easily than I used to, I can take part in just about all normal activities. I can go out to dinner with my husband. I can visit with friends.

This could all change on Friday, when the FDA is due to rule on its advisory panel’s recommendation to withdraw approval of Avastin. If the FDA does so, Medicare could stop paying for it. My doctor is hopeful that there will be an exception for people like me—perhaps I’ll be grandfathered in and allowed to continue my treatment regimen.

But I don’t know if that will happen, and I have to wait and see. If Avastin is withdrawn, countless women who might benefit from the drug will be denied. This is outrageous.

I don’t understand the government’s rationale.

The FDA says that it is considering withdrawal because Avastin doesn’t show enough promise against breast cancer. I find that very hard to believe. I’m proof that Avastin works.

The FDA is also concerned that Avastin has bad side effects. This is illogical—all chemotherapy has horrible side effects, too. As does every other medicine I’ve tried: Tamoxifen, Taxol, Taxotere, Navelbine, Etoposide, Arimidex and Faslodex. All cancer treatments are risky, and they all come with side effects.

But the worst side effect is death, and that’s guaranteed to happen when cancer isn’t treated.

Some claim that the FDA’s decision is about the money. It’s true that Avastin is expensive, but a medicine’s price tag shouldn’t allow the FDA to determine whether patients live or die.

Cancer usually comes back. It’s smart and tricky, so there is the possibility that at some point this combination of Avastin and Xeloda will stop working for me. If so, I hope that by then there will be another treatment available—or maybe even a cure. All I’m asking for is time for that new treatment to be developed.

Until then, Avastin is all I have. And I want to live.

Ms. Satossky lives in Reston, Va.

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