October 19th, 2011 by AndrewSchorr in Health Policy, Interviews
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If you’ve read my blogs for a while, or look up some past blogs, you’ll see I have been frustrated at times with the FDA. Yes, they have a tough job protecting us from medical products that are unsafe and/or ineffective. But when it comes to cancer, where we have few “homerun” therapies, I wish they were a bit more liberal. A “bunt single” might be good enough. You may have read how I have been critical of Dr. Rick Pazdur, the FDA leader for oncology drug approval. Some desperate patients and family members have referred to him as “Dr. No.”
Just the other day I interviewed a respected breast cancer survivor and patient advocate who has high respect for Dr. Pazdur. Musa Mayer of New York City is a 22-year breast cancer survivor and author of three books about breast cancer. She’s devoted her life to educating other patients about cancer and also playing a role in public policy. She has become a favorite patient representative on FDA cancer advisory boards and regularly weighs in when breast cancer drugs are being considered.
In my interview with Musa, she explained Read more »
*This blog post was originally published at Andrew's Blog*
September 9th, 2011 by GarySchwitzer in Health Policy, Opinion
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In a comment left on my blog, Jamie Bearse, the chief operating officer of Project Zero – The Project to End Prostate Cancer, showed how quickly and deeply discussions about screening tests can devolve into ugly rhetoric. Bearse wrote:
“Your comments along with Otis Brawley’s vendetta against the PSA sentence men to die from prostate cancer testing. Shame on you. It’s important to know your score to make a proper diagnosis and decision of if and how to treat prostate cancer. Groups that create screening guidelines for cancer such as American Urological Association and National Comprehensive Cancer Network say get tested. In fact, Brawley is at odds with his own organization. ACS supports testing as well. Otis Brawley has killed more men by giving them an excuse to not be tested. Don’t follow that path just because of your own bad experience.”
I responded:
“Jamie,
My comments policy states that I will delete comments that make personal attacks. You certainly did that with your statement that the chief medical officer of the American Cancer Society “has killed” and that he has “sentenced men to die.”
Nonetheless I have posted your comment because I think it’s important for other readers to see how some pro-screening rhetoric so quickly and completely devolves into ugliness.
…
YOU ARE WRONG Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
July 18th, 2011 by Elaine Schattner, M.D. in Opinion, Research
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Yesterday’s post was not really about Avastin, but about medical journalism and how patients’ voices are handled by the media.
L. Husten, writing on a Forbes blog, cried that the press fawned, inappropriately, over patients’ words at the FDA hearing last week, and that led him to wonder why and if journalists should pay attention to what people with illness have to say, even if their words go against the prevailing medical wisdom.
There’s a fair amount of controversy on this. For sake of better discussion in the future, I think it best to break it up into 3 distinct but inter-related issues:
1. About health care journalism and patients’ voices:
A general problem I perceive (and part of why I started blogging) is how traditional medical journalists use patients’ stories to make a point. What some of my journalism professors tried to teach me, and most editors I’ve dealt with clearly want, is for the reporter to find a person with an illness, as a lead, and then tell about the relevant news, and provide some expert commentary – with at least one person speaking on each “side” of the issue, of course – and then end the story with some bit about the patient and the future.
I argue that this form of medical journalism Read more »
*This blog post was originally published at Medical Lessons*
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*
