A June 29 Wall Street Journal editorial argued in favor of the FDA's approving use of the drug Avastin for end-stage breast cancer. After the drug was provisionally approved to treat breast cancer in 2008, the FDA withdrew its approval last year, and the drug maker, Genentech, has appealed that decision. The editorial claimed that "[o]ver three rigorous clinical trials, and in combination with chemotherapy," Avastin "improved 'progression-free survival." The article concluded that if the drug is not approved for breast cancer patients, "thousands of women may die more quickly and live with more pain because government regulators substitute their own opinions about clinical meaningfulness for those of oncologists and their patients."
In fact, as Media Matters noted, The New York Times reported in July 2010, studies found that "use of Avastin did not prolong the women's lives by a statistically significant amount" and that new studies "showed even fewer signs that it could prolong lives." Further, The Washington Post reported in August 2010 that "Avastin can cause a variety of potentially serious side effects, including blood clots, bleeding and heart failure."
From the Wall Street Journal editorial:
Avastin is a biologic that chokes off the flow of blood to tumors, and the FDA provisionally approved it for breast cancer in 2008. Last year, the agency decided that the drug did not offer terminally ill women "sufficient benefit." The agency has never withdrawn a treatment option for such a serious disease. In an unprecedented move, Avastin's maker, Genentech, has appealed to the FDA leadership above the drugs division. Thus this week's trial, with FDA bureaucrats as de facto prosecutors and Genentech scientists defending their medicine.
[Last year,] Genentech was supposed to show that Avastin improved "progression-free survival," the time women live without their disease spreading or worsening. Over three rigorous clinical trials, and in combination with chemotherapy, it did so, even if the results were less statistically robust in the follow-up studies. But [FDA cancer drugs chief Dr. Richard] Pazdur and his staff reviewers unilaterally revised the approval "endpoints" that Avastin was supposed to hit, to undermine the drug.
More broadly, the Avastin fight is about the FDA and its desire to more tightly control the development of cancer drugs. Avastin was initially approved under the FDA's "accelerated approval" process that is supposed to speed treatments for terminal illnesses and unmet medical needs. Dr. Pazdur, the New England Journal of Medicine and the rest of the medical-political establishment have decided that accelerated approval's flexibility is too friendly to commercial drug developers, and in Avastin they've found a pretext to gut it.
The FDA's anti-Avastin campaign is enforcing a culture of research and development that will discourage the innovation, investment and risk-taking that will be necessary to produce the next generation of cancer treatments. More imminently, thousands of women may die more quickly and live with more pain because government regulators substitute their own opinions about clinical meaningfulness for those of oncologists and their patients.