November 6th, 2008 by Dr. Val Jones in Opinion
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Wyeth vs. Levine is an important legal case being tried before the US Supreme Court. You may have read about the lawsuit in the New York Times, NEJM, JAMA, the Wall Street Journal, or my own blog. It revolves around the tragic story of a woman (Ms. Levine) who experienced an extremely rare side effect (severe tissue damage resulting in the amputation of her right arm) because a drug was administered improperly (into an artery rather than a vein). Ms. Levine is arguing that her injury could have been avoided if the drug label had stronger warning language, and the Vermont Supreme Court ruled in her favor, awarding her $7 million. The court ruled that a jury in the state of Vermont had the right to hold Wyeth accountable for a different labeling standard than the one approved by the FDA.
The plot thickens, however, in that Wyeth’s FDA-approved label very clearly discourages injection of their drug into or near an artery, and it also describes the potential consequence (including gangrene) of such an action. The FDA approved Wyeth’s label in full knowledge of the potential risks and benefits of the drug. In fact, Wyeth asked to strengthen the language of the label before Ms. Levine was injured, and the FDA declined to make the change because label changes are based on new information about a drug’s frequency or severity of risks. Wyeth had nothing new to disclose. Read more »
November 5th, 2008 by Dr. Val Jones in Medblogger Shout Outs, News
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This news from Gary Schwitzer’s excellent blog:
Dr. Nancy Snyderman of NBC News appeared on the Today Show with Matt Lauer last week, profiling a physician-author who has written that the best science does not establish a causal link between childhood vaccines and autism. 
Lauer, in a followup question, mis-spoke and called it a “casual” link – not causal. One wonders whether he truly knows what the words mean.
Snyderman talked about how the physician-author, Dr. Paul Offit (author of “Autism’s False Prophets”), has received death threats. Snyderman herself said she had been physically ambushed by those who contend that vaccines cause autism.
As Snyderman was wrapping up the segment, Lauer said – in typical anchor throwaway language:
“Controversial subject …”
Snyderman immediately shot back, “Not controversial subject , Matt. …It’s time for kids to get vaccinated. The science is the science. It’s not controversial.”
You can see the video here or here.
Kudos to Snyderman for educating her big-bucks anchor colleague live on-the-air.
For a full review of Offit’s book, please check out this link.
November 4th, 2008 by Dr. Val Jones in Opinion, True Stories
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Election anxiety has America on the edge of its seat. I anticipated long lines and a lot of drama, so I voted early to avoid the rush. That left me with nothing election-related to do today, so I decided to head over to my local pharmacy and get a flu shot instead.
Last year the flu vaccine was only 50% effective because experts did not correctly predict which viral strains would victimize Americans. This year I have my fingers crossed that the Brisbane and Florida strains included in the vaccine will do the trick. After all, Influenza is the single leading cause of vaccine-preventable disease in the U.S., with estimates between 15 million and 60 million cases in the US a year among all age groups. Influenza leads to 200,000 hospitalizations and about 36,000 deaths a year in the U.S., mostly in infants and the elderly. I’ll never forget the touching story of how one family lost their three and-a-half year-old daughter to the flu.
So I arrived at the pharmacy only to find a disorderly group of flu-shot seekers, pacing near the entrance to the retail clinic. About 20 minutes later a young woman with a clipboard and sign up sheets came out and started asking people what kind of insurance they had. When my turn came she informed me that my insurance plan was not participating, and suggested that I leave. I asked if I could pay out-of-pocket for the shot and she said that I could and gave me a consent form. More people arrived without any movement in the line, and I overheard one person commenting that the nearby polling booth wasn’t moving as slowly. Another customer decided to leave to go vote and then come back later for the shot.
Forty minutes later my name was called and I entered a small room littered with papers and syringe caps. I rolled up my right sleeve and asked the technician about his injection technique. I watched him carefully draw up half a cc of vaccine from a multiple-use bottle.
He then asked me how I was going to pay. I presented my credit card and he said that he only accepted cash or check. I said that I had no idea that credit cards weren’t accepted and he seemed surprised that I wasn’t aware of the retail clinic policy. A large envelope was leaning against his chair leg, full of $30 cash deposits for the shot. Read more »
November 4th, 2008 by Dr. Val Jones in Health Tips, True Stories
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I’m grateful to the Happy Hospitalist for pointing out that color matters when it comes to food consumption. As it turns out, blue light can be an appetite suppressant. And I actually know about this first hand.
I helped to design a research study in connection with Architectural Digest and the Parsons School of Design several years ago. I was a volunteer instructor for a hospital design course in NYC, and wanted to show the students that lighting could influence eating patterns. As it happened, there was a big gala event at a local convention center, and so I worked with my friend Shashi Caan to set up three identical rooms bathed in three different colored lights (yellow, blue, and red).
We had all the gala attendees dress up in white bunny suits (you know, the kind you let patients wear in the OR) and shuttled them through the 3 rooms at regular intervals. The rooms could each hold about 40 guests and copious identical hors d’oeurves were offered.
Guess what we found? The most food was consumed in the yellow room, followed by red, and then a distant third was blue. About 33% fewer snacks were consumed in the blue room during the event (and yes we controlled the number of people in each room so they’d be equal). I found this quite fascinating, but unfortunately never published the results. You see, I didn’t receive IRB approval for any of it.
But the experiment did leave an indelible impression on my mind. As I thought about it, I realized that most fast food restaurants have yellowish interiors. From the golden arches to the lighting – companies like McDonald’s probably recognized (long before I did) that color influences purchasing and eating behavior.
Yep, I’m late to this party – and I’m not painting my kitchen yellow.
November 3rd, 2008 by Dr. Val Jones in Expert Interviews, Opinion
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Following on the heels of the annual ACR scientific assembly (and my interview with Dr. Wallace), I reached out to Sandra Raymond, President and Chief Executive Officer of the Lupus Foundation of America, to discuss lupus from the patient perspective. Sandra’s rhinovirus infection (she had a cold) did not stop her from completing an excellent interview with me.
Listen to the podcast here, or read a summary of the interview below.
Dr. Val: Tell me about the Lupus Foundation of America (LFA).
Raymond: The Lupus Foundation of America is the nation’s leading organization dedicated to finding the causes and cure for lupus. We also provide services, support, and hope to all people living with lupus. We have a national research program called “Bringing Down The Barriers” and we fund grants to researchers in academic institutions across the country. We are also very active on Capitol Hill, lobbying for research and educational efforts. In a few months we’ll be launching a public awareness campaign to help Americans understand this disease.
Dr. Val: Of which key accomplishment of the LFA are you most proud?
Raymond: LFA has been able to expand medical research efforts for lupus. This not only gets us closer to finding a cure, but it offers hope to those who are living with the disease.
Dr. Val: In your view, what do patients with lupus need the most?
Raymond: They need safe, effective, and well-tolerated treatments. November the 20th, 2008, marks 50 years without a new, approved treatment for lupus. The treatments that patients are currently taking can be very harsh. They sometimes cause side effects that are worse than lupus itself! We must step up our research efforts to discover safe and effective treatments to bring this disease under control and provide patients with a better quality of life.
The good news is that there are quite a few pioneering biotech companies who are investing money in finding a cure for lupus. So there may be new drugs on the horizon.
Autoimmune diseases affect 23 million Americans. Lupus accounts for at least 1 million of those, but if we can figure out what causes lupus, there are implications for all disorders of the immune system. Read more »
