Saturday, November 19, 2011

Weekend Newsbites: Sat. & Sun., Nov. 19 & 20, 2011


I'm gonna miss Regis...
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1 comment:

William R. Barker said...

http://online.wsj.com/article/SB10001424052970203611404577046133283707236.html

The extraordinary Avastin saga has become a kind of randomized controlled trial, pitting the Food and Drug Administration's power against potentially life-saving drugs for terminally ill patients. The results are proving that the former is far stronger, with FDA Commissioner Margaret Hamburg's decision Friday to withdraw the biologic medicine as a treatment option for women with metastatic breast cancer.

* DO YOU KNOW PEOPLE WHO HAVE SUFFERED FROM AND BEEN KILLED BY CANCER? HAVE YOU PERHAPS HAD IT - OR AT LEAST CANCER SCARES? DO YOU FEAR YOURSELF OR A LOVE ONE BEING DIAGNOSED WITH CANCER ONE DAY? UNDERSTAND, FOLKS... THIS IS OBAMACARE... THIS DECISION REPRESENTS A "DEATH PANEL" DECISION FOR A CERTAIN NUMBER OF WOMEN IN THE NEAR, MID, AND LONG-TERM FUTURE.

In 2008, Avastin was initially cleared for breast cancer in combination with chemotherapy under "accelerated approval," the FDA program that was created in response to the AIDS crisis to speed drugs for incurable illnesses and other medical needs to market. (Avastin was first approved on the basis of progression-free survival, or PFS, the time women live without their disease spreading or worsening.)

In 2009 Genentech applied to convert to full approval, with new studies that also showed PFS improvements, even if they were less statistically robust than the initial trials. At that point cancer drugs chief Richard Pazdur moved to reassert the FDA's political culture of delay and control, rigging the re-review against Avastin and emphasizing safety risks. (The risks of Avastin are real, but they're also well-understood and manageable, especially in end-stage oncology where there are no good options. The FDA's real goal was to send a warning to the rest of the drug industry about who is in charge of drug development.)

The FDA withdrew Avastin's breast cancer approval last year - leading to Genentech's unprecedented appeal and a two-day trial in June. In her decision denying that appeal, Dr. Hamburg concedes that there are groups of "super responders" who experience dramatic improvements when treated with Avastin. But she then says those patients don't count because "it is not possible to determine if there is some subset of patients within the population as a whole that may have had a meaningful benefit."

(*ROLLING MY EYES*)

Dr. Hamburg also concedes that Avastin may produce better results when used with different chemotherapies, but that those prospects haven't been sufficiently tested.

* FOLKS... WE'RE TALKING ABOUT CANCER PATIENTS WHO ARE GONNA DIE - AND QUICKLY - ABSENT A MIRACLE. IF THERE'S A CHANCE AVASTIN IS THAT MIRACLE FOR THEM... (*SHRUG*)

How much progression-free survival would a drug need for the FDA to agree that it provides a "meaningful benefit"? Dr. Hamburg doesn't say.

Looking at the same studies, the European Medicines Agency (the FDA's continental equivalent) continues to approve Avastin for breast cancer.

The National Comprehensive Cancer Network, a highly respected consortium of U.S. oncology programs, has four times reaffirmed its recommendation that Avastin is "an appropriate therapeutic option."

[T]here's no denying that Dr. Hamburg's decision is an awful turn for anticancer progress and innovation, and especially for the women who may lose a treatment option in the time they have left to live.

November 20, 2011 at 10:31 AM

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