A Plea to the FDA

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By Josh Turnage

In June 2006, my mom was diagnosed with early stage two breast cancer.

Avastin, a cutting-edge cancer medicine, saved her life. But in December, the FDA is expected to withdraw its approval of the drug. (The decision was initially scheduled for September, but was recently postponed until Dec. 17.)

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When my mother was diagnosed with cancer, she had a double mastectomy, reconstruction, and six months of chemotherapy. Because she had “triple negative breast cancer,” a particularly rare and aggressive form of the disease, there were neither pills nor treatments that could keep the cancer from coming back. Sure enough, just one year after her diagnosis, the cancer had spread to her right lung. This meant she had metastatic, or stage IV, breast cancer.

In other words, her cancer had become incurable.

We did have a small bit of hope, though. Even though there ‘s not yet a cure for cancer, a new medicine — Avastin — had just been approved by the FDA, to be used in conjunction with chemotherapy. After just four treatments of medicine, all signs of cancer had left. My mom’s doctor couldn’t even find a trace of it.

Of course, because of chemotherapy, my mom was pale, sick, had to limit her activities. She also had to restrict her contact with people when she was ill, including my baby sister, to avoid getting infections. She subsequently had surgery to remove part of her lung just to make sure all the cancer was gone, and then four more doses of chemotherapy medications and Avastin.

At the time, my baby sister, who was adopted from China, was almost three years old. Seeing her mom so sick — and without any hair — was really frightening. She prayed all the time for her mommy to get healthy again.

In January 2009, my mom had her last chemotherapy treatment. Since then, she’s only been on Avastin. Twenty months later, she remains cancer free.

Today, you’d never know that my mom has incurable breast cancer. Just a few weeks ago, she helped my brother move into his college dorm room. She’s tired, but she has no problem pushing my little sister on the swing set at the local park.

My family — together with thousands of other families who have mothers, daughters, and sisters with breast cancer — are just asking the FDA to keep Avastin available for women with breast cancer.

This past summer, a panel of thirteen experts — only two of whom were breast cancer oncologists — advised the FDA to withdraw its approval of Avastin for metastatic breast cancer. While the panel admitted that Avastin does benefit many women with metastatic breast cancer, it didn’t think the benefits were strong enough.

The decision had nothing to do with new safety risks. Avastin, like all powerful drugs, comes with a number of risks and side effects. But my mom and her doctor decided it was worth it. That decision has not changed.

Wyndham Wilson of the National Cancer Institute, who chaired the FDA’s advisory committee, summed up its findings by asking if small gains in progression-free survival are clinically meaningful. I would say yes.

One extra day with a cancer patient is invaluable. An extra week — or even months or years? That can mean my little sister’s first day of elementary school. It could mean my college graduation. It could mean celebrating her 30th wedding anniversary with my dad. It could mean watching the birth of her first grandchild.

If the FDA withdraws its approval of Avastin, insurance companies, Medicaid and Medicare will undoubtedly consider denying coverage for the medicine. The life of a cancer patient is already limited. The last thing any family needs is to spend their final hours with a loved one fighting with insurance companies.

About 40,000 women will die from breast cancer this year. Medicines work differently for everyone, and not all Avastin users are as successful as my mom. But whether this medicine is beneficial enough should be up to patients, their doctors, and their families.

The FDA can still change course and preserve the right of breast cancer patients to make an informed choice. If someone you loved were diagnosed with breast cancer, wouldn’t you want the right to choose this drug?

Josh Turnage is a student at Mississippi State University. A video he produced about his mother’s fight against breast cancer can be viewed here: http://bit.ly/bXlUFB. Also, over 7,600 people have signed his mother’s petition to stop the FDA from disproving Avastin to treat metastatic breast cancer. The petition is available here: http://bit.ly/dvprpD.


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