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BYJENNIFER MECKLES
You're watching multisource health news analysis from Newsy.
Breast-cancer patients and doctors hoped Avastin would be a miracle treatment.
But since its debut on the market three years ago -- the FDA has been skeptical.
This week, a panel voted unanimously to revoke approval of the drug -- here’s ABC:
“Avastin is the best selling cancer drug in the world. The FDA panel ruling, which came down in the last hour clear away for the government to remove its endorsement of the drug. The panel claims the drug is ineffective in fighting breast cancer. However, doctors, patients, and the drug’s maker says it improves patients’ quality of life.”
The chemotherapy drug - created by Genentech -- is still approved to treat many other cancers -- including colon, lung, kidney and brain. NBC’s Brian Williams explains what the panel’s ruling means for metastatic breast cancer patients:
“The side effects can be unsafe for breast cancer patients. Avastin is still approved treat other forms of cancer, but this means now insurers wont pay for it as a breast cancer treatment.”
Stealing the headlines in this story -- patient reaction. Cancer patients and their families protested before the hearing and gave emotional testimony during it. At the heart of the debate? CNN reports -- money.
“The debate is highly charged. Some patients have accused the FDA of letting Avastin’s high cost – as much as $88,000 for a year – cloud its judgment. By regulation, the agency is not permitted to consider cost when it evaluates the safety and effectiveness of any treatment.”
CBS spoke to a woman who will be forced to make huge sacrifices to afford treatment:
“As far as future treatment goes - if the insurance companies decide they’re not going to cover Avastin, my husband tells me we’re going to have to sell our house. But I don’t really want to do that if I don’t I have to.”
Avastin was first introduced in 2008, and earned a fast track approval by the FDA for its seemingly successful results. Not until later did the agency deem it unfit to treat cancer.
The FDA says Avastin doesn’t extend life-- but doctors argue it does provide better quality of life. Both parties agree the side effects are serious enough for consideration. (Video: WPTY)
Cure Today says -- fast approval, then a quick revoke -- is evidence the process of testing new cancer agents is changing:
“It is now necessary to define predictive factors at the same time a drug is initially being developed. Not only is FDA approval in jeopardy, but drug companies can no longer afford the cost of huge trials to show a tiny difference in outcomes.”
Avastin is still approved for use overseas by the European Commission. And Reuters reports -- a spokesperson for Medicaid says that insurer will continue to cover the drug. FDA Commissioner Margaret Hamburg will make the final decision about Avastin -- that’s expected in late July.
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