With desperate breast cancer patients imploring the Food and Drug Administration to change its mind, the agency’s staff calmly argued Tuesday that the drug Avastin should lose its approval as a treatment for that disease.

The pleas and presentations came on the first day of a two-day hearing at which Genentech, the manufacturer of Avastin, is getting a chance to try to persuade the F.D.A. to reverse its decision made in December to revoke the drug’s approval for advanced breast cancer.

The proceedings emphasized a conflict that has bedeviled pharmaceutical regulation and other efforts to control the practice of medicine — one between cold statistics from clinical trials about overall populations and the often emotional experiences of individual patients who say a therapy has, or might, work for them.

About a dozen women with breast cancer, some tearful, told the F.D.A. that while Avastin did not show a big benefit over all in clinical trials, the medicine did help some women substantially and should be left available for that reason.

“Despite the potential side effects from Avastin, metastatic breast cancer has only one — death,” Priscilla Howard, who said Avastin had controlled her cancer for 32 months, told the committee presiding over the hearing. “I want every available weapon in my arsenal as I fight this devastating disease.”



Leave a Reply

Looking for something?

Use the form below to search the site:

Still not finding what you're looking for? Drop a comment on a post or contact us so we can take care of it!

Rss Feed Tweeter button Facebook button