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America's health watchdog is considering revoking its approval of the drug Avastin for use on women with advanced breast cancer, leading to accusations that it will mark the start of 'death panel' drug rationing.
A decision to rescind endorsement of the drug would reignite the highly charged debate over US health care reform and how much the state should spend on new and expensive treatments.
Avastin, the world’s best selling cancer drug, is primarily used to treat colon cancer and was approved by the US Food and Drug Administration in 2008 for use on women with breast cancer that has spread.
Originally posted by LadySkadi
reply to post by centurion1211
While I think this is disgusting to consider, I have to wonder how often it was approved for use by private insurance companies as well? It seems that they would also be looking for any opportunity not to pay for an expensive procedure. Once again, it's reiterated that if you don't have the money, you won't be taken care of to the best that we have to offer.
Avastin received accelerated approval for the treatment of advanced breast cancer in 2008 on the basis of a single clinical trial, which showed that when used with another drug, it slowed tumor progression but extended patients' lives on average by only about five months. In two subsequent post-marketing trials, Avastin was paired with different chemotherapy drugs than in the original trial and performed even less well, prolonging patients' lives on average by no more than three months.
The FDA advisory committee voted 12 to 1 in July to recommend that regulators revoke the approval for breast cancer. (Because it is approved for treatment of other cancers, Avastin would remain on the market and at physicians' discretion could be used "off-label" for breast cancer; but off-label, a hugely expensive treatment — a wholesale cost of $88,000 for a typical breast cancer patient — would be less likely to be covered by insurance.)
Originally posted by links234
'Death panels' have been in existence for years in the private industry, they just call it denial of coverage for certain expenditures. It's the same thing.
Against the advice of a previous advisory committee, the FDA in 2008 gave Avastin "accelerated approval" for the treatment of spreading breast cancer, in combination with chemotherapy. As a condition of that approval, Genentech agreed to conduct two new clinical trials.
Those trials showed no evidence that Avastin offered an overall benefit to breast cancer patients. In contrast, the drug added significantly to the side effects of chemotherapy.
But clinical trials showed little evidence that breast cancer patients benefit by adding Avastin to chemotherapy. The drug increased the rate at which these patients experienced serious side effects.
Briefing documents prepared for the panel by FDA staff painted a dim picture, suggesting Avastin's risks outweigh its benefits.
But Genentech noted that Avastin did not shorten patient survival, and that the drug should be tried in more patients with metastatic breast cancer in order to find out how it might best be used.
Originally posted by maybereal11
Where do the "Death Panels" come in again?
[edit on 17-8-2010 by maybereal11]