In an op-ed for The New York Times, oncologist Frederick Tucker Jr. says that despite the criticism FDA received when it rescinded approval for the use of cancer drug Avastin for the treatment of breast cancer, and despite a push from maker Genentech to get it reapproved, FDA should stick to its guns — because when it comes to breast cancer, Avastin doesn't work. In the seven years it has been on the market, Avastin — combined with other drugs — has been effective in treating some colon, lung, kidney, and brain cancers, Tucker says. But trials done by Genentech show that while Avastin — which can cost up to $90,000 a year for a single patient — paired with chemotherapy drugs can halt the growth of breast cancer for longer than chemotherapy alone, it doesn't necessarily prolong life, and could have more toxic side effects than other treatments. But perhaps more "troubling," Tucker says, is that the company has resorted to anecdotes in its brief to FDA and the media, presenting stories from oncologists who have used Avastin successfully in breast cancer patients as proof that it should be reapproved. "But anecdote is not science," Tucker says. "Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories." Avastin will remain on the market and remains available for use with other cancers, and research into Avastin's use in breast cancer continues. But FDA needs to resist Genetech's attempts to "have it ignore scientific evidence," Tucker adds. "Serious progress in the treatment of cancer will not be the result of polemics, lobbying or marketing. Genentech's money and efforts would be better spent on research for more meaningful treatments for breast cancer."
'Anecdote Is Not Science'
May 26, 2011