“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*
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of Sciences (PNAS) — promoted in a news release by the journal and picked up by many news organizations — has now been retracted by the authors.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*
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*