I was diagnosed five years ago with breast cancer. After 7 surgeries including a mastectomy and reconstruction, I’m cancer free, but not a day goes by when I don’t think about having cancer.

Have you or someone you love been touched by breast cancer? The FDA is holding two days of hearings on June 28th and 29th to determine if the drug, Avastin will continue to have government approval for use in late stage breast cancer. And you can get involved!

Watch the proceedings on-line on June 28th and 29th by registering at:

Submit your comments on-line by July 14 to: FDA-2010-N-0621.


Read more about the drug and breast cancer below:

The Food and Drug Administration (FDA) and Genentech, the maker of the drug, Avastin, square off on June 28th and 29th in a hearing at FDA headquarters to determine if Avastin will continue to have government approval for use in late stage breast cancer.

In a May 6, 2011 letter, FDA Presiding Officer Karen Midthun, prepped committee members saying, they should think of the proceedings as a “trial.” If the FDA prevails and Genentech loses, Medicare and other payers will stop paying for the drug when used for breast cancer and patients will pick up the entire bill out-of-pocket, upwards of $100,000 annually. Some analysts estimate a loss of $1 billion in sales for Genentech attributed to the breast cancer indication.

Avastin, known as a biologic that works by reducing the flow of blood to tumors, is approved for lung, kidney, brain and colon cancers. However, its downfall is its cost.

The whole controversy - where medical science, economics, politics, dying patients and their doctors intersect - takes a more complicated turn thanks to the debate over healthcare reform. Last July, an FDA Advisory Committee recommended that the approval for Avastin in breast cancer be withdrawn. Within days, Sen. David Vitter (R-La.) reignited the debate over healthcare rationing by arguing that the recommendation “marks a “sickening” case of the government threatening access to care.” Vitter said the panel’s vote is “analogous to the government denying care because the patient’s life is not deemed valuable enough.”

An article in the August 18, 2010 Wall Street Journal titled “The Avastin Mugging,” defended the drugs effectiveness and criticized the FDA advisory board that recommended withdrawing government approval of Avastin as a treatment for breast cancer.

Medicare and other payers are eagerly awaiting the verdict. One Medicare claims processor, Palmetto GBA, jumped the gun and issued a “no payment” decision last December, just 11 days after the FDA announced it was taking the first steps to remove the indication for breast cancer.

Amid a storm of controversy, the “no payment” decision was immediately retracted and a spokesman for Palmetto GBA said that they would continue paying for Avastin during the appeals process. If fully implemented this would have affected patients in North Carolina, South Carolina, Virginia, West Virginia, California, Nevada, and Hawaii. 

Stuart P. Leitner, M.D., FACP is the Section Chief of Medical Oncology at Saint Barnabas Medical Center in Livingston NJ and a researcher in breast cancer comments, “Avastin is an active drug in metastatic advanced breast cancer and trials have consistently shown the same results. My patients have truly benefitted from it. The FDA’s decision to withdraw approval for metastatic breast cancer is just plain wrong.”

Regardless of the decision on breast cancer use, the drug will still stay on the market for other cancers. Recent studies show 20 percent of drugs prescribed in the U.S. are for “off-label” uses. So the question is not, “can we get the drug for breast cancer patients,” but “who is going to pay for it.”

So how will the FDA decision play out?

Citizens providing oral testimony are expected to plead for continued access and payment for themselves or their loved ones, the FDA will plead that there is insufficient evidence for continued approval for breast cancer, and of course, Genentech will be pleading that although patients may not live longer, they have a better quality of life while alive. Science cannot answer whether the modest benefit is worth the cost, but that ethical question is at the heart of the debate.

FDA Commissioner, Margaret Hamburg, M.D. is expected to issue a final ruling in mid-September. If FDA approval is withdrawn, Genentech options include seeking a judicial review of the decision based upon two days of testimony.

I pray that you will take the time to get involved in this decision important to cancer patients!



Breast Cancer Drug Trial-(click here for MP3 file)