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Avastin: The FDA’s “Disappointing Decision”

“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*

Medical Journal Retractions: A Transparency Issue

Interesting case study raised by the Retraction Watch blog.

A 2009 journal article in the Proceedings of the National Academy of Sciences (PNAS) – promoted in a news release by the journal and picked up by many news organizations — has now been retracted by the authors. But the journal issued no news release about the retraction — an issue of transparency that the RW blog raises. And you can guess how much news coverage the retraction will get.

And this was all over a molecule that could supposedly “make breast tumors respond to a drug to which they’re not normally susceptible” — as the RW blog put it. But it was also a molecule, RW points out, that wasn’t even in clinical trials yet.

He or she who lives by the journal news release risks one’s long-term credibility.

*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*

Breast Cancer Diagnosis And Treatment: Can Women Trust It?

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*

Latest Interviews

IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

It’s no secret that doctors are disappointed with the way that the U.S. healthcare system is evolving. Most feel helpless about improving their work conditions or solving technical problems in patient care. Fortunately one young medical student was undeterred by the mountain of disappointment carried by his senior clinician mentors…

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How To Be A Successful Patient: Young Doctors Offer Some Advice

I am proud to be a part of the American Resident Project an initiative that promotes the writing of medical students residents and new physicians as they explore ideas for transforming American health care delivery. I recently had the opportunity to interview three of the writing fellows about how to…

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Latest Book Reviews

Book Review: Is Empathy Learned By Faking It Till It’s Real?

I m often asked to do book reviews on my blog and I rarely agree to them. This is because it takes me a long time to read a book and then if I don t enjoy it I figure the author would rather me remain silent than publish my…

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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