FDA panel votes against Avastin for breast cancer treatment

Source: Washington Post

A Food and Drug Administration panel took a major step Wednesday toward ending use of the best-selling drug Avastin for treating advanced breast cancer in the United States, despite appeals from distraught patients and the company manufacturing the drug.

A crucial six-member FDA advisory committee unanimously concluded that the drug was harming women more than it was helping them. FDA Commissioner Margaret A. Hamburg must make a final decision, but agency commissioners usually follow advisory panel recommendations.

The fate of the drug for breast cancer has been closely watched by patients, oncologists, women’s health advocates, health-care policymakers, politicians and the pharmaceutical industry. The case has triggered strong reactions from advocates of easier access to new treatments and from critics fearing health-care rationing. It is also being seen as one of the most visible medical examples of scientific evidence winning out over an animated public outcry. Ultimately, clinical trials failed to support the drug’s early promise for breast cancer treatment.

“I think we all wanted Avastin to succeed, but the reality is that these studies did not bear out that hope,” said Natalie Compagni Portis, who represented patients on the panel.



Read more: http://www.washingtonpost.com/national/health-science/fda-panel-votes-against-avastin-for-breast-cancer-treatment/2011/06/28/AGfGmMrH_story.html

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The right-wing will accuse the FDA of "rationing care", but in reality, Avastin has shown very little effectiveness against breast cancer, and has shown adverse side effects.

Women are not allowed to attempt to save themselves from dying, because the treatment may harm them?

it plainly said that patients survival rates for those who received Avastin vs. those who did not receive Avastin made no difference in mean survival times but the risk due to the side effects, which is long and nasty, is not worth the risk. This was a six to zero vote with the review board. In this case science trumps.

I worked on one project with Avastin and Oxaliplatin years ago (end stage colorectal cancer) and the Avastin group had more severe adverse events that were attributable to the Avastin. Just because someone is terminally ill does not mean that it is appropriate to harm them with chemotherapy that is not effective. That goes against the mandate of the FDA. In my opinion, and I work in the clinical research oncology setting, Avastin should be used sparingly and not for all cancers based on the past and ongoing clinical trials. Since the labeling of this drug will be amended, any off label use in light of the safety issues will put the physicians at risk for lawsuit by patients or their families if harm is attributed to the Avastin, which is well documented.

edited to tame the rhetoric.

Not on voodoo science, not on emotion, but the cold-hard facts through many clinical trials.