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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*

Is Looking At “Long Term” Impossible In Our Healthcare System?

I spent last week in Gothenburg, Sweden covering the European Committee for the Treatment of Multiple Sclerosis (ECTRIMS) meeting. Lots of good science, lots of excitement over the new oral and targeted therapies coming on the market to treat this awful disease. But what I want to write about isn’t the science, but about how it will play out in the brave new world of healthcare in which we all live in today.

For instance, consider the first oral therapy to hit the market: Gilenya (fingolimod), which the FDA approved in September. Last month Novartis announced the price: $48,000 a year.

This is not a rant against the high cost of drugs, however. It is a rant against the inability of our healthcare system to take the long view of the impact of such drugs, a view that is particularly important with a chronic disease like MS that strikes healthy young adults in their early 20s and 30s. Read more »

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

There’s Nothing More Important Than Your Health

I don’t do well with pain. I learned that lesson all too well during the birth of my first son when, after 10 hours of labor jump-started by a pitocin drip, I finally got an epidural. Nothing — and I mean nothing — has ever felt as good as the ebbing of that pain. I relearned the lesson during the birth of the second son, this time determined to go natural all the way when, after a few hours, I told the doula to “shut up” and ordered my husband to hunt down the anesthesiologist and “Get me an epidural — NOW!” He listens well.

By the time the third son was born, I had the drill down pat. I was admitted to the hospital to be induced again but this time, as soon as the IV was hooked up and before the first labor pain hit, I had the anesthesiologist in the room putting in the epidural. It was a completely painless birth — and a lot of fun.

My issues with pain extend to my issues with being sick. I simply do not like not feeling ill. I’ve been very lucky and extremely blessed in my life — the most serious thing I’ve ever had wrong with me was strep throat or a stubborn sinus infection. As a medical writer, I’m far too familiar with all the things that could go wrong with me, so I feel guilty even complaining about my minor issues. Read more »

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

Avastin For Breast Cancer: Will The FDA Revoke It?

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*

U.S. Healthcare: When Is Enough Enough?

A new survey in the journal Health Affairs synthesizes nearly everything I believe is wrong with the U.S. healthcare system. The survey found that patients believe that more care is better, that the latest and most expensive treatments are the best, that none of their doctors provide substandard care, and that evidence-based guidelines are a pretext for denying them the care they need and deserve.

Sigh.

Until we can retrain consumers (that would be all of us) to understand that in medicine more is NOT better, that evidence-based guidelines may translate in some instances into less but better care, that doctors are falliable and should be questioned, and that the cost of a treatment has nothing to do with the quality, we will never get out of the healthcare quagmire in which we find ourselves.

Your thoughts?

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

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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