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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.

For more than 50 years, that system has included the role of the FDA in approving drugs for marketing based on two things: Their clinical efficacy and their risks. Which tips the scales higher? Are there other options available with better efficacy and fewer risks? If this is government takeover of healthcare, than I say. . . bring it on. 

 I don’t know about you, but I’ve got enough on my plate what with earning a living, nagging the 18-year-old about college and scholarship applications, advising the 14-year-old on girlfriend issues, figuring out tonight’s dinner, making sure my husband feels appreciated and loved, keeping up the house, and tossing the ball for the puppy to add “assessing risk/benefit ratio of pharmaceutical compounds” to my to-do list.

I also appreciate the government “interfering” in healthcare when it requires that medical professionals meet certain requirements for licensing; that hospitals and other healthcare facilities follow certain rules and regulations for safety and quality; and that drugs be manufactured according to good manufacturing guidelines. I’m only 48, but when I’m 65 and get my Medicare card, I think I’m also going to embrace that form of government “interference” in my healthcare.

Your thoughts?

*This blog post was originally published at A Medical Writer's Musings on Medicine, Health Care, and the Writing Life*


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One Response to “Avastin: The FDA’s “Disappointing Decision””

  1. This commentary regarding the FDA being involved in some great attempt to take over healthcare demonstrates grandstanding or complete ignorance as to the value that these organizations serve in protecting the health and welfare of the public. Without such organizations, the public would suffer from contaminated foods and sloppy testing of pharmaceuticals just for the “freedom” of being able to get whatever they want whenever they want. That an elected official can make such ignorant commentary may just highlight why certain aspects of the American Healthcare system are so inefficient – there are too many uninformed individuals trying to undermine and manipulate it.

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