Taken from the September/October 2011 issue of The Women's Health Activist Newsletter.
Avastin (bevacizumab), the top-selling cancer drug in the world, is useful for some cancers, including lung, colon, kidney, and brain cancer. But, it doesn’t work for breast cancer. Nonetheless, of the $7 billion that Avastin generates for Roche / Genentech annually, about $1 billion comes the drug’s use for breast cancer treatment.
Three years ago, the Food and Drug Administration (FDA) granted Avastin “accelerated conditional approval” for the treatment of late-stage breast cancer patients who were already taking Taxol (paclitaxel). The FDA gave this approval over the objections of its own Advisory Committee, which noted that no evidence supported an improvement in either symptoms or survival for breast cancer patients taking the drug. Since then, studies conducted with over 3,000 women with breast cancer found that Avastin failed to slow disease progression or reduce death rates in women who received both Avastin and chemotherapy. Moreover, women treated with Avastin had more hemorrhages and other serious adverse effects.
As a result of these findings, in December 2010, the FDA announced that it was going to withdraw Avastin’s approval for breast cancer. On June 29, 2011, the FDA Oncologic Drugs Advisory Committee unanimously concurred with this decision. This was an evidence-based, scientifically uncontroversial decision.
So why did a couple of dozen breast cancer patients attend the hearing to give testimony opposing the withdrawal decision? We suspect, although we don’t have proof, that these patients were brought to the hearing by Roche’s Genentech unit. Drug companies and their public relations vendors have long recruited health care providers and medical groups to act as neutral-appearing mouthpieces for the companies’ marketing messages. Industry has also co-opted (or created) consumer advocacy groups to these ends, and is now recruiting individual patients who are influential on social media sites as “opinion leaders” to help disseminate the companies’ marketing messages. The patients who testified before the FDA may truly believe that Avastin kept them alive, but women who died from the drug, needless to say, weren’t available to testify.
Appallingly, Karen Midthun, who presided over the FDA hearing, turned down a request from the FDA’s own lawyers to disclose the presenters’ conflicts of interest. That’s right; although the members of FDA’s Oncologic Drugs Advisory Committee are required to disclose any conflicts of interest, presenters who defended women’s right to choose an ineffective and expensive drug didn’t have to disclose that they — or the organizations they represent — were paid by the company that makes the ineffective and expensive drug.
One of the voices of reason, Vernal Branch, from Breast Cancer Action, was actually booed by some audience members when she stated that the FDA should base its decision about Avastin on science, rather than on “ any individual story, no matter how compelling.” Here’s another great quote from Ms. Brunswick: “We all want better treatments for women with metastatic disease. Evidence has shown that Avastin is not that treatment.” (NBCC does take some money from pharmaceutical companies).
Treatment with Avastin costs about $88,000 a year. Because the drug is available to treat other cancers, Avastin can still be prescribed off-label for breast cancer treatment even if the FDA withdraws approval. (At press time, the FDA had not made a final decision on that.) Insurers may refuse to pay for the use of Avastin for breast cancer treatment, however, which is a perfectly reasonable decision for something that hasn’t been shown to work.
Belief isn’t fact, which is why we do scientific studies. And why decisions about what drugs are approved and what drugs are used to treat various diseases should be based on such scientific studies. That’s why you should trust the few health groups in the country, including the NWHN and Breast Cancer Action, that don’t take industry money. So be proud that you’re a Network member, and consider joining Breast Cancer Action as well (their website is: http://bcaction.org).
Charlea T. Massion, MD, is a practicing physician in Santa Cruz County specializing in hospice and palliative care. Charlea brought her passion for improving women’s health along with 40+ years of health care experience to the NWHN as a member of the board for 8 years. She also co-founded the American College of Women’s Health Physicians.
Adriane Fugh-Berman, MD, is a former NWHN Board Chair whose research presents a critical analysis of the marketing of prescription drugs. Adriane educates prescribers on pharmaceutical marketing practices as Director of the PharmedOUT program, and created the Health in the Public Interest program at Georgetown University School of Medicine where she trains a new generation of consumer advocates.
The continued availability of external resources is outside of the NWHN’s control. If the link you are looking for is broken, contact us at [email protected] to request more current citation information.
ABC News, “Avastin Pits Breast Cancer Patients Against FDA Experts”, June 28, 2011. Available at: http://abcnews.go.com/ Health/ BreastCancerCenter/breast-cancer-patients-fight-avastin-breast-cancer-drug/story?id=13949539.
Sell D, “If FDA withdraws approval of Avastin for breast cancer, insurers could stop covering it”, The Philadelphia Inquirer, July 1, 2011.
Branch V, “Testimony for Food and Drug Administration (FDA) Hearing on Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin),” Presented on June 28, 2011, Breast Cancer Action News, 2011. Available at: http://bcaction.org/2011/06/28/testimony-for-fda-hearing-on-proposal-to-withdraw-approval-for-the-breast-cancer-indication-for-bevacizumab-avastin.
Mundy A. “Avastin Caught in Debate”, The Wall Street Journal, June 29, 2011. Available at: http://online.wsj.com/article/SB10001424052702304314404576414010214261834.html.