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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*

Your Pharmacist’s Role In Safe, Effective Prescription Drug Treatment

This is a guest post from Dr. Mary Lynn McPherson.

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Rescuing Patients On Darvon Or Darvocet With Zero Tolerance For Pain

On November 19, 2010 the Food and Drug Administration (FDA) called for a halt in the use of the popular opioid pain relievers Darvocet and Darvon. These products contain the opioid propoxyphene, and it has been used to treat mild to moderate pain for over 50 years. However, concerns have long been raised about the effectiveness of this drug, and the risk of death (accidental and suicide). Darvon and Darvocet were banned in Britain in 2005, followed by the European Union in 2009. Over the past 30 years, the FDA has received numerous petitions to take these drugs off the U.S. market.

Research has shown that Darvon and Darvocet are no more effective for treating moderate pain than over the counter drugs like acetaminophen, aspirin or ibuprofen. Unfortunately, Darvon and Darvocet cause a lot more side effects such as dizziness, drowsiness, nausea and vomiting, hallucinations and constipation (all pretty typical of opioids used to treat pain). But, the side effects don’t stop there. The data is in, and it’s not a pretty picture. A recent study requested by the FDA showed that when used at the recommended doses, Darvon and Darvocet cause significant changes in the electrical activity of the heart, which can lead to a fatal irregularity in your heartbeat, even after only short-term use.

Among those advocating for the removal of these drugs from the market were pharmacists. The American Society of Health-System Pharmacists approved a policy in 2007 advocating for the withdrawal of Darvon and Darvocet from the U.S. market, and recently testified at the FDA Advisory Committee to this effect. As an often overlooked member of the medical team, pharmacists have a vital role to play in providing safe and effective treatments. We serve as the last line of defense against improper or unwise prescribing of drugs — especially those for pain. We are drug experts, and we can help patients and doctors switch from Darvon or Darvocet to safer and more effective treatments. Read more »

Acupuncture Via SkyMall

The worst part of flying is the takeoff and landing. Not that I am nervous about those parts of the trip, it is that I am all electronic. Once I have to turn off my electronic devices, all I am left with is my own thoughts or what is in the seat pocket in front of me.

Since there is nothing to be gained from quiet introspection, I am stuck with either the in-flight magazine or SkyMall. I usually choose the latter. SkyMall, for those of you who do not fly, is a collection of catalogs bound in one volume. I have occasionally purchased products found in SkyMall and thumb through it with mild interest.

This time one product caught my eye, the Aculife home acupuncture/acupressure device. I had never noticed the “health”-related products in SkyMall before, usually looking for electronic gadgets that I really do not need. I was curious. How many other products besides Aculife are in the catalogue? According to the interwebs, about 100,000,000 Americans fly every year and well over half a billion people world wide. A lot of people can potentially look at SkyMall, including the occasional skeptic.

I have written about the many styles of acupuncture in the past: Hand and foot and tongue and ear and head and Chinese and Japanese. So many meridians and acupuncture points, how does the body find room for it all? Aculife makes it all simple. It’s all gauche, er, I mean in the left hand.

According to makers of Aculife, you can now “help strengthen your health with the latest ancient technology.” Of course I can, and for $199.95 I had better be able to. Read more »

*This blog post was originally published at Science-Based Medicine*

New Cigarette Labels From The FDA

The FDA will soon require new cigarette package labeling to deter smoking. So in politically-correct governmental fashion, they are asking which labels you’d like to see. (You can pick your favorites here.) My personal favorite (so far) is the one shown to the left, but its impact factor pales in comparison to this example found in England. (That, my friends, is cancer!)

Ironically, it appears the FDA isn’t too sure how forceful it should be in these warnings about the dangers of smoking. They offer a cornucopia of milquetoast labeling options, many of which contain cartoons. Might such unrealistic portrayals defy they hard-hitting message they want to project? Worse, at least one cartoon (seen here) even seems to promote cigarettes AND drug use together!

In an even more astonishing example, some images almost make me what to take up smoking so I can blow big bubbles. Since I could never do this well before, maybe I should take up smoking! Seriously, is an empowerment message what the government wants to portray?

Make these labels big, ugly, and real. Anything else is a waste of taxpayer’s money.

-WesMusings of a cardiologist and cardiac electrophysiologist.

*This blog post was originally published at Dr. Wes*

High Cholesterol And Red Yeast Rice Supplements

People are always on the search for “natural” ways to stay healthy and reduce cholesterol. Chinese red yeast rice supplements have been touted as a natural, safer way to lower cholesterol compared to statin medications. The yeast that grows on a particular type of rice contains a family of substances called monocolins, which lower cholesterol by inhibiting cholesterol production in the liver in the same manner as prescription statin drugs. Some studies have shown as much as a 15 percent drop in cholesterol.

All of this sounds good until you dig a little deeper. Supplements are not regulated by the Food and Drug Administration (FDA), and a new study in the Archives of Internal Medicine showed that different brands of red yeast rice supplements have dramatic variation in levels of active ingredients. Furthermore, some contained toxic manufacturing by-products. Read more »

*This blog post was originally published at EverythingHealth*

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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