The Food and Drug Administration has started a series of hearings concerning Avastin, a popular breast cancer medication. The drug has a loyal following of cancer survivors who have been helped by the drug, but authorities assert the benefits don’t outweigh the risks.
Regulators say benefits of cancer drug are few
The Food and Drug Administration is beginning a series of hearings concerning Genentech’s cancer drug Avastin. Genentech is a subsidiary of Roche AG, a Swiss pharmaceutical company. FDA approval was revoked in December of 2010 f0r use of the drug in treating advanced cases of breast cancer, according to Fox. The hearings, according to CBS, are being picketed by a number of different groups, including women whose lives were saved by the drug or are being treated for breast cancer with Avastin and seeing positive results. However, the FDA has asserted that its approval was revoked because studies indicate the drug only delays progression of breast cancer for a few months and doesn’t decrease the death rate, according to the Washington Post. Avastin can cause high blood pressure, heart attack, blood clots, kidney damage and intestinal perforation.
Useful for multiple forms of cancer
Avastin, or bevacizumab, inhibits angiogenesis, according to Wikipedia; it keeps tumors from growing blood vessels. The drug is also prescribed for treating colon, kidney, lung and brain cancer. According to the Wall Street Journal, a pair of studies recently found that Avastin inhibited ovarian cancer growth in both newly diagnosed patients and patients in whom the cancer was recurring. Avastin was showed in one trial to delay progression in recurring ovarian cancer by four months. The other study, according to the Los Angeles 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 deaths from ovarian cancer when taking Avastin. However, the long-term effect on death rates remains to be seen. Ovarian cancer has an overall survival rate of about 47 percent, according to Wikipedia.
Financial ties called into question
Possible financial ties to Genentech and parent company Roche AG are being called into question concerning testimony on behalf of the drug, according to the San Francisco Chronicle. No one who speaks at the FDA hearings on behalf of the drug will have to disclose whether she has any financial incentive to promote the drug at the FDA hearings. Avastin represented more than $6 billion in sales for Roche in 2010, and a full course of treatment costs $88,000. The initial approval of the drug in 2008 was controversial, as the drug was fast-tracked under an FDA program that allows for ground-breaking medication to reach the market faster than normal to see if it works, but the drug has to prove that its risks are outweighed by the benefits. Studies that factored in the FDA’s decision to pull approval showed that the drug merely delayed tumor growth by a few months at best, and didn’t decrease the death rate overall.
Wall Street Journal:http://on.wsj.com/koeP0H
Los Angeles Times: http://articles.latimes.com/2011/jun/04/news/la-heb-avastin-ovarian-cancer-06042011
Wikipedia on Avastin/Beviacizumab: http://en.wikipedia.org/wiki/Bevacizumab
Wikipedia on Ovarian Cancer: http://en.wikipedia.org/wiki/Ovarian_cancer
San Francisco Chronicle: http://bit.ly/klWKvq
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