A panel of cancer experts decided Wednesday that the cancer drug Avastin should no longer be approved by the Food and Drug Administration for breast cancer patients. The panel claimed it was ineffective and had dangerous side effects. The FDA will rule in July. The drug, manufactured by the Swiss drug maker Roche, had been approved for patients with metastasized breast cancer. Metastasized means the cancer has reached an advanced stage and spread to other parts of the body. Avastin has been the best-selling cancer medication in the world.
Avastin’s second trial
This is the second time a panel has ruled negatively on the cancer drug. Last December, a panel agreed that Avastin didn’t extend or improve the life of breast cancer patients. However, protests by Roche prompted an unprecedented second hearing.
Avastin was initially granted approval to treat breast cancer in 2008 because it demonstrated in studies its ability, when combined with chemotherapy, to slow advanced breast cancer tumor growth for more than five months. But further studies have shown the benefit was closer to three months and that the drug did not extend the life of the patient. In addition, the panel claims the drug has severe side effects including high blood pressure, internal bleeding and holes in the stomach.
Cancer survivors give testimony
In addition to expert testimony, Roche offered the testimony of breast cancer survivors. “I am alive today due to Avastin,” testified survivor Patricia Howard.
“Make no mistake, this hearing is a death trial, not of Avastin but of these women who rely on Avastin to say alive,” said Terry Kelley, the husband of a breast cancer patient. “You are each personally responsible for the consequences of your own vote.”
After two days of discussion and testimonies, the panel unanimously reaffirmed its opinion in a 6-0 vote. Natalie Compagni-Portis, a member of the panel, said, “I think we all wanted Avastin to succeed, but the reality is that these studies did not bear out that hope.”
Avastin supporters speak out
After the decision was handed down, the room exploded with negative reactions from the drug’s supporters. Christi Turnage, of Madison, Miss., who claims her cancer has been undetectable in the two years since she has been taking the drug, shouted, “What do you want us to take? We have nothing else!”
Steven Walker, a spokesman for the patient advocacy group the Abigail Alliance, called it a kangaroo court. “There wasn’t one dissenting thought up there, let alone one dissenting vote,” he said.
Awaiting decision by the FDA
The panel’s decision is not binding, and the FDA’s commissioner Margaret Hamburg will make the final determination after July 28. Avastin is still FDA approved for brain, kidney and colon cancers. It could technically still be used to treat breast cancer even if unapproved, but it is likely that insurance companies will refuse to pay for the expensive drug.
Huffington Post: http://www.huffingtonpost.com/2011/06/28/avastin-breast-cancer-patients_n_886217.html
Do you have a fantastic idea related to this article, but just don't have the money you need to start your own company or side-business? Get the loans you need from https://personalmoneynetwork.com to help get your new company underway, from the small loan professionals at PersonalMoneyNetwork.