The FDA has started a number of hearings concerning Avastin, a popular breast cancer medication. The drug has helped some people, but the Food and Drug Administration asserts that studies prove too few benefits to justify approving the drug for use as a breast cancer remedy given the risks of use. Source for this article - FDA mulls future of breast cancer drug Avastin by Newsytype.com.
Dangers of drugs are too good
Avastin, Genentech's cancer drug, is going to start going through proceedings with the FDA. Roche AG, which is a Swiss pharmaceutical business, is the parent business of Genentech. Food and Drug Administration approval was revoked in Dec. of 2010 for use of the narcotic in treating advanced cases of breast cancer, as reported by Fox. The proceedings, as reported by CBS, are being picketed by numerous different groups, including women whose lives were saved by the drug or are being treated for breast cancer with Avastin and seeing optimistic outcomes. However, the FDA has asserted that its approval was revoked because studies indicate the drug only delays progression of breast cancer for a few months and does not decrease the death rate, as reported by the Washington Post. High blood pressure, blood clots, intestinal perforation, kidney damage and heart attacks can all be brought on by Avastin.
How it helps other cancer
Angiogenesis is inhibited by Avastin, or bevacizumab. Tumors won't grow blood vessels with it, as reported by Wikipedia. Colon, kidney, lung and brain cancer have all used the narcotic as treatment also. There were studies done recently to see how Avastin worked with ovarian cancer, as reported by the Wall Street Journal. It showed that both new patients and recurring cancer sufferers had ovarian cancer inhibited with Avastin treatment. There was a four month delay in recurring ovarian cancer from Avastin shown in a trial. Another study, as reported by the LA Times, found women newly diagnosed with ovarian cancer had a slightly lower death rate overall when taking Avastin, and those at the greatest risk for recurrence had a 36 percent reduction in fatalities from ovarian cancer when taking Avastin. However, the long-term impact on death rates remains to be seen. Ovarian cancer has an overall survival rate of about 47 percent, as reported by Wikipedia.
Why the testimony is questioned
Possible financial ties to Genentech and parent business Roche AG are being called into question regarding testimony on behalf of the drug, according to the San Francisco Chronicle. No one who speaks at the FDA hearings on behalf of the narcotic will have to disclose whether she has any financial incentive to promote the narcotic at the FDA hearings. Over $6 billion in Roche sales was represented in 2010 by Avastin. About $88,000 is needed for a full course treatment. The drug had an approval in 2008 that was very controversial contemplating it was on the FDA fast-track program which means it was able to get to the industry faster than normal with proof that it works, although the advantages may not outnumber the risks. Studies that considered the FDA's decision to pull approval showed that the narcotic merely delayed tumor growth by a few months at best, and did not decrease the death rate overall.
Wall Street Journal
Los Angeles Times
Wikipedia on Avastin/Beviacizumab
Wikipedia on Ovarian Cancer
San Francisco Chronicle