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December 17, 2010

FDA says no more Avastin to treat breast cancer (Death panel rationing begins)

Topics: Health Issues, Political News and commentaries

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In what is essentially the beginning of the Obama administration's process of rationing health care and a sentence of an earlier-than-necessary death for thousands of women, the FDA has decided that it will no longer approve Avastin for treatment of breast cancer:

(CBS) - The FDA is recommending the blockbuster drug Avastin no longer be used to treat breast cancer.

The agency says recent studies show the drug does not help slow the spread of the disease.

The decision by the FDA will not affect approval for treating other cancers like colon and lung cancer. The makers of the drug are requesting a hearing to challenge the recommendation.

As one might reasonably expect, the reaction to the FDA's decision has been fierce:

Rep. Kay Granger: "For the 17,500 women across the country who rely on Avastin to survive, I am extremely disappointed the FDA has chosen to take away one of the very few options for the treatment of late-stage breast cancer. To make matters worse, this announcement comes on the same day that European drug regulators approved the continued use of Avastin for women with late-stage breast cancer. It is troubling that women in Germany and France will soon have access to a life-saving drug, while women in the U.S. will not. I will continue to work in the 112th Congress to ensure doctors and patients continue to have access to every available treatment option."

Rep. Rodney Alexander: "As expected, the Obama administration has begun its process of rationing health care with its announcement to remove Avastin from the market for women suffering from metastatic breast cancer. Today's decision to limit women's access to a lifesaving treatment is amiss, and indicative of the frightful direction our health care system is headed. For the government to deny access to such a viable treatment is a severe intrusion into personal health care decisions that should be left between the patient and the doctor. Given that this drug helps over 17,000 patients manage their disease, it appears this move is merely based on cost cutting and rationing rather than on any real medical grounds. Avastin has extended the lives of thousands of individuals suffering from this devastating disease. Going forward, they will no longer be afforded that opportunity. This decision represents the first major example of things to come if components of the recent health care overhaul are allowed to continue. I will work with others in the incoming majority to restore the fundamentals of the U.S. health care system."

Susan B. Komen Foundation for a Cure: Komen for the Cure's president, Elizabeth Thompson said that the organization is concerned about the potential impact on women who are benefitting from Avastin if the FDA ultimately removes its approval for the drug for breast cancer treatment. "We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it and that the drug's manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs and considers an expanded access program."

Sally Pipes, Pacific Research Institute: "The FDA claims its decision had nothing to do with Avastin's cost and was based solely on the drug's medical effectiveness. This isn't believable. Every year about 40,000 American women die from breast cancer. Avastin is the last hope for many not to meet that fate. While the drug is costly, it often provides immense benefits to patients."

Sen. David Vitter: "With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug. We can't allow this government takeover of health care to continue any further. I urge the FDA to consider any forthcoming appeals of this decision and immediately reverse course."

More reactions here ....

Posted by Richard at December 17, 2010 11:24 AM



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