A Win for Breast Cancer Patients and a Challenge to a Drug Maker

By Gail Garfield Schwartz

From Advocacy News & Views

Breast cancer patients scored a win this month when medical wisdom triumphed over drug company hype at the Federal Food and Drug Administration (FDA). The oncology advisory panel voted 6-0 to withdraw approval for Avastin for breast cancer. This unanimous vote virtually assures that the FDA Commissioner, who makes the final decision, will pull the temporary approval granted in 2008 on the basis of evidence that later proved misleading.  

The panelists agreed that Avastin does not prolong life or improve quality of life in metastatic breast cancer patients. Moreover it is extremely toxic and often kills the patient. 

The drug's manufacturer, Genentech, ran its publicity engines in overdrive for many months, to influence patients and their doctors to demand continued FDA approval. At hearings held June 27 and 28 at FDA, advisory panel members were treated to emotional witnesses begging for continuation of the breast cancer indication that costs the health care system $88000 per patient per year, giving Genentech revenues of $1 billion a year.

But four advocates testified in favor of withdrawal--including SHARE's own Helen Schiff.  Helen was able to represent the views of many knowledgeable advocates who take part in SHARELeaders. SHARELeaders spent many months reading about and discussing Avastin's pros and cons. Some initially thought Avastin should keep its indication for breast cancer "just in case" in might help. But over time as the evidence was exposed, just about everyone involved in these discussions came to the same conclusion that the FDA panel reached. 

For breast cancer patients now taking this dangerous drug who want to continue it, there will be no legal reason why they can't take it, if they can find a doctor to prescribe it "off label." But insurance companies may (and should) decide not to reimburse for it. Genentech, which earns $7 billion annually from  Avastin for all cancers, should give it to them free.

Posted July 5, 2011.