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Wyeth Vs. Levine: Joe Six Pack Trumps The FDA

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug -  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here are the highlights from the interview (a podcast is available here)…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

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Posted in: Pharmaceuticals, Politics and Regulation

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Double Standards – Newsweek and Tom Harkin

There has been a flurry of news relevant to science-based medicine in the last week – more than enough to keep a bevy of bloggers busy. More important than the individual news items themselves is the striking pattern they bring into focus when viewed together – the growing and pernicious double-standard between mainstream medicine and so-called CAM.

Begley vs Doctors

Science editor Sharon Begley wrote an interesting piece in Newsweek with the provocative title: Why Doctors Hate Science.  I was not particularly impressed with the article – it took a rather narrow approach to a complex problem and ran with it. She writes:

It’s hard not to scream when you see how many physicians, pharmaceutical companies, medical-device makers and, lately, hysterical conservatives seem to hate science, or at best ignore it. These days the science that inspires fear and loathing is “comparative-effectiveness research” (CER), which is receiving $1 billion under the stimulus bill President Obama signed. CER means studies to determine which treatments, including drugs, are more medically and cost-effective for a given ailment than others.

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Posted in: Politics and Regulation, Public Health

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Bad Books

In the interests of fairness and intellectual honesty, I’ve forced myself to read a lot of really bad books. The True Believer tells me his guru’s book is the Real Stuff. He tells me I have a closed mind and won’t look at anything outside establishment dogma, and if I only read the book and understood Dr. Quack’s evidence and arguments, I would be a True Believer too. I have tried, really I have. I’ve given the Dr. Quacks every chance to convert me, and I’ve hoped to learn something new, but I’m always disappointed. I’ve come to the point that I feel like I’m reading the same book over and over: it is always a mixture of real science, pseudoscience, and speculation, based on cherry-picked evidence and argued with the same logical fallacies.

I recently got hooked into reading another one by a correspondent who had called me an “ignorant relic” for writing a “grossly ignorant article” about alternative medicine. I suggested he read R. Barker Bausell’s book Snake Oil Science and a couple of others, which he promised to do. Then he said, “If I am willing to buy three books that you have suggested and read them and you are not willing to read what I have suggested, then that pretty much says all that needs to be said.”

I was willing, even though the very title of the book suggested that its message was incompatible with the scientific evidence as I know it: How to Prevent and Treat Cancer with Natural Medicine. The authors are big names in naturopathic and herbal medicine: Michael Murray, Tim Birdsall, Joseph Pizzorno, and Paul Riley. It’s nowhere near as bad as some of the bad books I’ve read, but it is a good example of the genre and I’ll use it to illustrate why I call them bad.

It offers “an arsenal of disease-fighting tools for prevention, treatment, and coping with side effects” (Yes, it offers tools; but do those tools work?) And it promises to “change your internal environment so cancer can’t survive.” (Wow! If it could really do that, every oncologist in the world would enthusiastically adopt these methods and the authors would be eligible for a Nobel prize.)
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Posted in: Book & movie reviews, Herbs & Supplements, Science and Medicine

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Tom Harkin’s War on Science (or, “meet the new boss…”)

This was cross-posted at White Coat Underground, despite the topic having been covered by Dr. Gorski yesterday. The topic is important enough that many of us in the medical blogosphere are going to be talking about this.

Remember when President Obama said something about returning science to it’s rightful place? Well, our new president has a real tough climb ahead of him. The previous administration shoved science aside for political expediency and religious ideology. Now, forces in the president’s own party are trying to insert their own quasi-religious beliefs into health care reform, leaving science in a whole different place altogether.

Here’s the deal. Some years back, Senator Tom Harkin (D-IA) helped set up the National Center on Complementary and Alternative Medicine (NCCAM). The whole idea of setting up such an agency is a bit quixotic—after all, the National Institutes of Health already study health science. As my colleagues and I have written many times before, the very idea of the agency seems ridiculous. Many, many studies have been funded which fail basic tests of plausibility and ethical propriety. Also, a huge percentage of the studies funded fail to ever publish their results. Still, some studies have been published, and more often than not, they find that the “alternative” modality being studied fails to behave better than placebo. That’s probably the sole redeeming quality of the agency, but not enough to keep it open, as these studies could have been done under the auspices of the NIH.

It turns out that Senator Harkin agrees with me on one point: NCCAM is failing to validate many alternative modalities. The difference is that I find it heartening and Harkin finds it disturbing:

“One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.”(from last week’s hearings, time marker approx. 17:20)

Well, at least he’s honest. He comes right out and bemoans the fact that science hasn’t upheld his quasi-religious medical beliefs. He just doesn’t get it. If you choose to investigate a scientific question, you have to be prepared for “bad news”. You don’t get to decide the outcome before the fact.

But Harkin makes his goals very clear, from his prepared statement, to the “experts” from whom he took testimony.
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Posted in: Politics and Regulation, Science and Medicine

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The incredible shrinking vaccine-autism hypothesis shrinks some more

Just when I thought I was out… they pull me back in.

Michael Corleone in The Godfather, Part 3

I hadn’t planned on doing two vaccine posts with such a short interval between them, but all too often, as the they say in the weakest of the Godfather movies, I get pulled back in again. So, after noting last week that 2009 was shaping up–fortunately–to be a very bad year for antivaccinationists, I should have expected a counterattack from the antivaccine fringe. Indeed, the only thing that surprised me after the twin blows of the revelations about scientific fraud on the part of the originator of the claim that the MMR vaccine causes autism, Andrew Wakefield, and the resounding defeat of the first three test cases of the Autism Omnibus proceedings, was that it took longer than I had expected. True, a group had formed, proclaiming that “we support Dr. Andrew Wakefield.” Also true, the antivaccine activists at the Age of Autism have been working overtime to attack the Autism Omnibus as being hopelessly rigged. Indeed, our “old friend” Dr. Jay Gordon has even likened attempts to refute antivaccine pseudoscience to tobacco companies’ P.R. and astroturf campaigns back in the 1950s through 1980s to cast doubt on the strong scientific and epidemiological evidence showing that cigarettes cause lung cancer.

But those contortions of science, epidemiology, law, and logic were merely a warmup for the real counterattack. On February 25, Generation Rescue purchased this full page ad in USA Today:

GenRescue_ad

Unfortunately, the advertisement above was only the beginning. Generation Rescue managed to team up the chief progagandist for the antivaccine movement, David Kirby, along with Robert F. Kennedy, Jr., whom I have discussed before for his total support of the antivaccine movement. The question then becomes: Where would these two team up to spread their message against vaccines? Do you even have to ask?

Their twin articles appear on that repository of all things antivaccine, The Huffington Post, under the title Vaccine Court: Autism Debate Continues. As I will explain, these twin articles represent yet another example of what I have at times referred to as the “incredibly shrinking vaccine-autism hypothesis.”
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Posted in: Science and the Media, Vaccines

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Senator Tom Harkin: “Disappointed” that NCCAM hasn’t “validated” more CAM

Senator Tom Harkin (D-Iowa) owes me a new irony meter.

I’ll explain in a minute, but first you have to know why I even care about what Harkin says or does, given that he’s not my Senator. As you may recall, arguably no single legislator in the U.S. has done more to harm to the cause of promoting science- and evidence-based medicine than Tom Harkin. That’s because it was primarily through Harkin’s efforts that the National Institutes of Health, despite the fact that its scientists were not agitating for it, had the National Center for Complementary and Alternative Medicine (NCCAM) rammed down its throat in 1992, first as the Office of Alternative Medicine (OAM), then in 1998, when NIH Director Harold Varmus tried to place OAM under more scientific NIH control, by elevating OAM to a full and independent Center within the NIH. Thus was NCCAM born.

I’ve complained many times about how NCCAM funds studies that, let’s face it, are of pseudoscience and quackery (homeopathy, anyone?) and even more about how it promotes unscientific medical practices. I’ve argued time and time again that there is no research that is funded by NCCAM that couldn’t be dealt with as well or better by other Centers or Institutes within the NIH. I’ve even argued that NCCAM should be defunded and dismantled, allowing CAM grant applications to be evaluated by the most appropriate center, as has our fearless leader Steve Novella. Most vociferous of all has been my fellow SBM blogger Kimball Atwood, who has made similar arguments at even greater length. I’ve also pointed out Harkin and other CAM-friendly legislators created and managed to increase the funding of NCCAM to the tune of $120+ million a year not for the purpose of rigorous scientific evaluation of CAM practices, but rather to promote CAM and ultimately “integrate” it with scientific medicine. At this they have been enormously successful.

Let me clarify. What I meant is that NCCAM, along with the Bravewell Collaborative, has been very successful in popularizing CAM in medical academia; at “proving” that CAM works, not so much. Evidence that this is so comes from a recent observation that Senator Tom Harkin is very, very unhappy with NCCAM these days and has publicly said so recently, as pointed out by Lindsay Beyerstein, daughter of the late, great skeptical psychologist Barry Beyerstein. On Thursday, Harkin told a Senate panel, Integrative Care: A Pathway to a Healthier Nation, that he was disappointed that NCCAM had disproven too many alternative therapies. (His remarks begin about 17 minutes into the video on the webpage to which I linked.) In addition, Harkin’s statements have also been posted to his Senate blog:
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Posted in: Politics and Regulation, Public Health, Science and Medicine

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CAM on campus: Homeopathy

I am quite proud of my medical school. The dedicated faculty and dynamic curriculum produce graduates of excellent clinical skill with a strong sense of service. Initially I was too focused on coursework to pay much mind to the student-run interest group in “cross-cultural and integrative medicine” and the occasional extracurricular CAM event. More recently, however, I noticed that such events had become a highly-publicized, monthly occurrence. It was still very much outside the official curriculum, but the discussion was one-sided with no public debate.

In addition to the student group on my local campus, we have a “CAM institute” that boosts CAM across the wider university. The CAM institute is a major sponsor of events organized by the student group in addition to producing its own lecture series and publications. The events hosted by either group are of two types. The first kind is an activity for med students that essentially functions as stress management: a yoga instructor leads free sessions between lectures once a week, and free herbal tea or massages are offered during final exam week. Who can complain about that? The massages are quite popular.The second kind of event is a lecture or workshop on a particular CAM modality.

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Posted in: Homeopathy

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Another new blogger for SBM

I’m pleased to announce that I’ve found another blogger for SBM, someone who will represent a viewpoint that I think is very important: That of the physician-in-training. So please welcome Tim Kreider to the stable. Tim is an MD/PhD student at a public university in the northeast US. He never paid much mind to pseudoscience until discovering The Skeptics’ Guide to the Universe and other podcasts that now keep him company during long nights in lab. He practices his skeptical analysis on extracurricular lectures organized by a student interest group for integrative medicine on campus.

As a graduate student, Tim is investigating immune mechanisms in a mouse model of gastrointestinal helminth infection. As a medical student, he has no idea what specialty to pursue and would love advice. He loves to teach math and science and hopes to pursue a career in medical academia.

We’re very happy to have Tim on board. Given that one of my concerns is the infiltration of pseudoscience into the medical school curriculum, I consider it essential to have a medical student on board to give that perspective. Because of his academic load, Tim will be blogging only once a month, although I do hope to tease a little more out of him, as long as it doesn’t jeopardize his education.

Posted in: Announcements

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A Medical-Skeptical Classic

The medical literature slowly becomes outdated. As a result there are not that many ‘classics’ in the field, since their content becomes less relevant. The medical aphorism is that 10 years after graduation from medical school, half of everything you learned will no longer be valid. The problem for medical students is trying to figure out which half of their curriculum is not worth learning.

Old studies become increasingly irrelevant as diagnosis and treatment changes over time under the relentless pressure of medicine. I once came across the best of Osler, with his descriptions of typhoid fever and pneumococcal pneumonia. The essays were far more literary in style than today’s journal articles, describing the presentation of these diseases in Dickens-like detail, but of little practical help given the advances in treatment and the understanding of the microbiology of diseases.

Technology also expands and limits what papers are available. If there is not an electronic form of an article, it might as well not exist. Many classic articles are not yet available in digital form, and the article in question for this post I had to get as a scanned version of the original paper, rather than a pdf. As a result of time and lack of electronic access, much of the older medical literature is not easily accessible, and journal publishers are not particularly interested in the free dissemination of information. Which is a shame. There is the occasional older reference that is as applicable today as when it was published. (more…)

Posted in: Clinical Trials, Science and Medicine

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How To Get Physicians To Use The Same Science-Based Playbook

Pretty much everyone agrees that we need to improve the quality of healthcare delivered to patients in the US. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.

However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.

There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.

I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.

Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.
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Posted in: Politics and Regulation, Public Health, Science and Medicine

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