December 21st, 2010 by Debra Gordon in Health Policy, Opinion
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“With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug. . . We can’t allow this government takeover of health care to continue any longer.”
That quote, courtesy of this morning’s [Dec 17th] Washington Post, incensed me to such a degree that I am writing this blog despite the two deadlines I have today. The speaker is Sen. David Vitter (R-La). The “disappointing decision” he refers to: The FDA’s decision to remove the breast cancer indication for Avastin (bevacizumab).
I wrote about this earlier, and you can read the post here, but that was before yesterday’s [Dec 16th] decision. I’m not going to comment here on the benefits or risks of Avastin. . . except to say that I’m sure there are individual women who are alive today because of it, and, quite possibly, individual women who are dead today despite it. But that’s not how we do medical science, based on individual patients. We do medical science based on large clinical studies (which are often designed with and approved by FDA officials). It’s not a perfect system, but it’s the system we have. Read more »
*This blog post was originally published at A Medical Writer's Musings on Medicine, Health Care, and the Writing Life*
August 19th, 2010 by Debra Gordon in Better Health Network, Health Policy, News, Opinion, Research
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Time to get back up on my soap box.
Next month the FDA is supposed to consider taking the unique, first-time-ever step of revoking a drug’s indication not because it’s dangerous, but because it doesn’t work well enough to offset its risks. Never mind that it costs about $8,000 a month.
The drug is Avastin (bevacizumab), a targeted monoclonal antibody that prevents tumors from creating and maintaining their own blood supply, a process called angiogenesis. Without oxygen and nutrients from blood, tumors can’t keep growing.
Avastin is the world’s best-selling cancer drug, approved for use with chemotherapy to treat lung cancer and metastatic colorectal and breast cancer. It is also being investigated (and, likely, being prescribed off label) for numerous other cancers. The problem comes with breast cancer. Read more »
*This blog post was originally published at A Medical Writer's Musings on Medicine, Health Care, and the Writing Life*
July 22nd, 2010 by AndrewSchorr in Better Health Network, Health Policy, News, Opinion, Quackery Exposed, Research
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The news wasn’t good this week for women concerned about breast cancer.
First came the story that some women were diagnosed with breast cancer, very early stage, had treatment –- including disfiguring surgery -– and then found out they never had cancer in the first place. The pathologist goofed, maybe even a second pathologist also misread the biopsies.
How does this happen? Not surprisingly it comes back to the clinical experience of the doctor. Properly diagnosing breast cancer, whether through radiology scans or pathology biopsies is not always easy. And in many communities the general radiologists and pathologists just don’t have enough specialized experience. This leads to mistakes, especially when the suggestions of possible cancer are subtle and minute. Read more »
*This blog post was originally published at Andrew's Blog*
