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Shame on PBS!

I used to have a high opinion of PBS. They ran excellent programs like Nova and Masterpiece Theatre and I felt I could count on finding good programming when I tuned into my local PBS channel. No more.

It was bad enough when they started featuring Deepak Chopra, self-help programs, and “create your own reality” New Age philosophy, but at least it was obvious what those programs were about. What is really frightening is that now they are running programs for fringe medical claims and they are allowing viewers to believe that they are hearing cutting edge science.

Neurologist Robert Burton has written excellent articles for salon.com pointing out the questionable science presented by doctors Daniel Amen and Mark Hyman in their PBS programs. Please click on the links and read what he wrote. These programs are being shown during fundraising drives as if they were examples of the best PBS has to offer. (more…)

Posted in: Science and the Media

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How not to think

Thankfully, I don’t receive all that much blog-related mail.  But this weekend I received several communications about a piece in popular liberal blog.  The piece is (ostensibly) about Lyme disease, which coincidentally happens to be one of the topics of my first post here at SBM.  In fact, I’ve written about Lyme disease a number of times, and Dr. Novella has a very good summary of the controversy at one of his other blogs.  Since we’ve discussed this so many times, I won’t be reviewing the entire controversy, but looking at this particular blog post to examine how our personal experiences and errors in reasoning can distort our view of reality.

The topic of Lyme disease has come up recently in the press, and as the weather improves, cases in the northeastern U.S. should start to increase soon.  Just as a reminder, so-called “chronic” Lyme disease is not Lyme disease at all.  Lyme disease can have early and late manifestations, none of which correspond to the vague, protean symptoms labeled as “chronic” by some.  The disease is often diagnosed without resort to objective evidence, such as reliable, positive lab tests.  But let’s look at the blog post in question and see what’s there.

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Posted in: Diagnostic tests & procedures, Science and Medicine

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When fraud undermines science-based medicine

The overriding them, the raison d’être if you will, of this blog is science-based medicine. However, it goes beyond that in that we here at SBM believe that science- and evidence-based medicine is the best medicine. It’s more than the best medicine, though; it’s the best strategy for medicine to improve therapy for our patients. We frequently contrast science-based medicine with various forms of “complementary and alternative medicine,” specifically pointing out that SBM changes its practices as new science and new evidence mandates it while CAM tends to rely on ancient, vitalistic, pre-scientific or pre-modern scientific beliefs about how disease occurs as the basis for its therapies. Although it may be painfully slow and frustrating at times and even though there may be major stumbles along the way, the overall course of SBM over the last century has in general been to produce ever more effective therapies and to discard therapies that are either ineffective or whose risk-benefit ratios are insufficiently favorable. The one single most important thing behind the advancement of medicine is good science.

That’s why I really, really hate scientific fraud, and I’m really, really upset, perhaps even more so than Dr. Atwood, over the discovery last week of what is arguably one of the most massive scientific frauds in medical history. It doesn’t matter that Dr. Atwood is an anaesthesiologist and I am not, meaning that the specific scientific fraud unearthed, which was perpetrated by an anesthesiologist studying multimodal anesthesia, as reported in Anesthesiology News, the Wall Street Journal, and the New York Times. I am a surgeon, and the relief of surgical pain in my patients is an important part of my practice. If the scientific basis of what my colleagues in anesthesiology do before, during, and after my operations is called into doubt, I have to wonder if I am giving my patients the best surgical care. Aside from that, there is the intellectual outrage I feel as a result of seeing science and patients betrayed in such a systematic and blatant manner.
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Posted in: Clinical Trials, Health Fraud, Pharmaceuticals, Science and Medicine, Surgical Procedures

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I Work with Steve Martin

Partly as an antidote to the previous, depressing post, and partly because it is so deserving of exposure, I now present—verbatim except for names and other ‘identifiers’—a recent email exchange between one of my colleagues and a correspondent. It has nothing to do with SBM. My colleague, known to his friends as T-Bone, is the reluctant owner of a vacation house in Florida. He must rent it as much as possible, since no one is willing to buy it. He gets frequent queries from potential renters, but usually not of the sort illustrated below. T-Bone is a very funny person. This exchange reminds me of the pieces that Steve Martin did for the back page of the New Yorker a few years ago.

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From: Carlos Buffett <epoosin@shizchengin.com>

To: T-Bone Seidler

Sent: Friday, January 23, 2009 11:12 AM

Subject: HouseHere inquiry about LandSilence 2468 from Carlos Buff 

Dear T-Bone Seidler,

Carlos Buff has sent the following inquiry about property number 2468 in LandSilence. To reply to this inquiry, simply call the phone number contained in the inquiry or reply to this e-mail.

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Posted in: Humor

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Scientific Fraud Hits Home

Last week the story broke that Scott Reuben, an anesthesiologist and clinical researcher at Baystate Medical Center in Springfield, MA, had falsified data in at least 21 publications over a period of at least 12 years—making it one of the most enduring examples of scientific fraud in memory. Almost all of Reuben’s papers had reported innovative methods for providing post-operative pain relief (analgesia); many of them involved ‘multimodal’ regimens for painful orthopedic procedures such as spinal fusions and total knee replacements. Recent papers reported regimens that included celecoxib (Celebrex) and pregabalin (Lyrica), both made by Pfizer. Much of Reuben’s research had been funded by Pfizer, and Reuben has been a member of the Pfizer speaker’s bureau (that information is included because the reader would otherwise wonder, but there is no indication that Pfizer has been intentionally involved in Reuben’s fraud).

I will not discuss this case in detail; look for a more comprehensive piece on SBM next week. Rather, I present it now to offer a local example of how such a breach of trust affects those who rely on clinical research to inform their care of patients.

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Posted in: Clinical Trials, Health Fraud, Pharmaceuticals, Science and Medicine

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Evidence-Based Legislation? Lessons From Abroad

President Obama appears to be refreshingly pro-science in his outlook, publicly lauding objectivity and careful analysis. He has even been credited with saying that “we need evidence-based legislation” in regards to public policy. The New York Times reports:

Agencies will be expected to pick science advisers based on expertise, not political ideology, the memorandum said, and will offer whistle-blower protections to employees who expose the misuse or suppression of scientific information.

The idea, the president said in remarks before an audience of lawmakers, scientists, patients advocates and patients in the East Room, is to ensure that “we make scientific decisions based on facts, not ideology”: a line that drew more applause than any other.

But when it comes to healthcare reform, many policy decisions put us in uncharted territory, with intelligent arguments on both sides of many legislative options and no American historical frame of reference to help us determine the best course of action. In times like these, perhaps the best we can do (to promote “evidence-based legislation”) is to study similar policy decisions made by our Canadian and European counterparts.

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Posted in: Politics and Regulation

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The GAO Report on Supplement Regulation

We advocate for Science-Based Medicine partly because science incorporates various generic intellectual virtues to which everyone should aspire. These include logical and clear thinking, unambiguous definitions, and internal consistency. In fact it is demonstrably true that opposing science often equates to promoting muddied and sloppy thinking, ambiguous language, and self-contradiction.

Last week I wrote about that latter virtue – consistency – and its lack when dealing with regulating physicians vs regulating so-called complementary and alternative medicine (CAM). In fact CAM exists, in my opinion, specifically to create a double-standard to disguise contradictory standards. It is institutionalized compartmentalization to minimize public cognitive dissonance.

This week, as promised, I will discuss how the same double standard has been made to apply to the regulation of supplements vs pharmaceuticals. The recently published Government Accountability Office (GAO) report on supplement regulation by the FDA brings this to light.

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Posted in: Herbs & Supplements, Politics and Regulation

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The China Study

One of our readers asked that we evaluate a book I had not previously heard of: The China Study: Startling Implications for Diet, Weight Loss and Long-Term Health, by nutrition researcher T. Colin Campbell, PhD, with his non-scientist son Thomas M. Campbell II. The China Study was an epidemiologic survey of diet and health conducted in villages throughout China and is touted as “the most comprehensive study of nutrition ever conducted.” The book’s major thesis is that we could prevent or cure most disease (heart disease, cancer, diabetes, autoimmune diseases, bone, kidney, eye and other diseases) by eating a whole foods plant-based diet, drastically reducing our protein intake, and avoiding meat and dairy products entirely.

Opinions of the book

There’s a lot of praise for this book on the Internet. It was named VegNews Book of the Year. PETA loves it (not surprisingly). Heather Mills McCartney calls it inspirational. It was featured on Oprah.com and endorsed by two of her favorite doctors: Mehmet Oz and Dean Ornish. Its author was even interviewed on Coast to Coast AM.

But I also found this critical review which makes some excellent points and accuses the authors of misrepresenting the findings of the study. And this commenter on an Amazon.com forum also charges Campbell with misrepresenting the data from the study and points out numerous flaws in his reasoning.

Problematic references

I didn’t look at the praise or criticism of others until after I read the book, and the following represents my independent impressions. I approached the book as I do any book with scientific references: I read until I come across a statement of fact that strikes me as questionable and then I check the references given for the statement. This immediately got me off on the wrong foot with this book. In the first chapter I found the statement:

Heart disease can be prevented and even reversed by a healthy diet. (more…)

Posted in: Book & movie reviews, Cancer, Nutrition

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An all-too-common breast cancer testimonial for “alternative medicine”

One of the consistent themes of SBM since its very inception has been that, when it comes to determining the efficacy (or lack thereof) of any particular medicince, therapy, or interventions, anecdotes are inherently unreliable. Steve Novella explained why quite well early in the history of this blog, and I myself described why otherwise intelligent people can be so prone to being misled by personal experience and anecdotal evidence. Unfortunately, as I have also demonstrated, it’s not just patients who can allow themselves to be misled by anecdotes, but certain physicians who do not understand the scientific method but in their hubris think that their “personal clinical experience” trumps science, clinical trials, and epidemiology.

None of this is to say that there aren’t frequent instances when applying data from population-based studies to individual patients is problematic. It can indeed be. However, it often goes beyond that, and, indeed, if there is one defining characteristic of a quack that I’ve never failed to find when looking at individual cases, it’s a belief that he is able to identify when a treatment works based on his own personal experience and anecdotes. Unfortunately, it’s not just quacks who sometimes fall prey to this, because humans are cognitively wired to infer causation from correlation. This tendency, which was no doubt adaptive early in our evolution, simply doesn’t work well when it is applied to medicine and science. Without a doubt, it is the key driver, for example, behind the widely believed myth that vaccines somehow cause autism and that chelation therapy and other biomedical quackery can “cure” autism, a view popularized most recently by the very popular but very ignorant Jenny McCarthy in the U.S. and before that by the outright dishonest Andrew Wakefield in the U.K.

One of the other reasons why testimonials for quackery seem convincing is because most people simply do not know enough about disease, be it my specialty (cancer) or any other disease, how it is treated, and what its natural course can be expected to be. That is why, when I came across an example of just such a testimonial, specifically a breast cancer testimonial, I saw what is known as a “teachable moment. This teachable moment occurred on the very popular science blog Pharyngula, written by the ever sarcastic biology professor from Minnesota, P.Z. Myers. It actually surprised me in that the usual topics on Pharyngula include evolution, biology, the pseudoscience known as “intelligent design” creationism, politics, and atheism. P.Z. doesn’t usually dabble much in the realm of medical quackery, but my guess is that he was attracted to this particular piece of pseudoscience because of the religious angle.

Specifically, the quackery under consideration is known as God’s Answer to Cancer (GAC). Basically, it looks a lot like any number of quack electronic devices that promise to cure cancer; examples include Bill Nelson’s Electro Physiological Feedback Xrroid (EPFX) machine (1, 2, 3), Hulda Clark’s parasite zapper, or Alan Back’s Advanced Bio-photon Analyzer. All of these devices promise, in essence, to use low level electrical energy to “boost the immune system” and “replenish your life energy” plus or minus an additional promise to “zap parasites” (Hulda Clark’s unique spin on these devices, in which she claims that all cancer, AIDS, and most other diseases are due to a liver fluke, which her device supposedly “zaps.” Like these devices, the maker of GAC promises vague “immune system boosts,” but with the added twist that he claims that all disease is due to original sin (along, apparently, with the conventional alt-med “toxins,” diminished qi, and uncharacterized immune dysfunction). Amusingly, the Monsignor who created this device also disses Hulda Clark and advocates the use of laetrile and Linus Pauling’s orthomolecular medicine. The main difference is that he claims to have received the design for the device from God through a dream.
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Posted in: Cancer, Health Fraud, Science and Medicine

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NCCAM is a victim of its own history

Let me begin with a story. An assistant professor submits a reasonable application to NCCAM to investigate the potential metabolic and pharmacodynamic interactions of St. Johns wort with conventional chemotherapy. This was the year or year-and-a-half before SJW was known to have significant CYP3A4 inductive activity due primarily to its component, hyperforin. Said investigator used this preliminary data, not explicitly required for theNIH funding mechanism (called an R21), to question whether St. John’s wort used by depressed cancer patients might interfere with chemotherapy. The original proposal earned a priority score of 228 (as with golf, the lower the better: the best is 100, the worst is 500.)

The major reviewer critique was that the assistant professor, Your Humble Pharmacologist, lacked, at the time, significant natural products chemistry expertise. YHP was then doing his sabbatical in the NC Research Triangle area and wisely sought the support and expertise of the now-late Dr. Monroe Wall and surviving Dr. Manuskh Wani. These gentlemen discovered and solved the structures of taxol from Taxus brevifolia and camptothecin from Camptotheca acuminata. Taxol itself became a blockbuster drug for Bristol-Myers Squibb while camptothecin required water-soluble modifications to foster topotecan (Hycamptin) and irinotecan (Camptosar) that collectively saved or prolonged the lives of thousands of men and women subjected to breast, ovarian, lung, and gastrointestinal tumors. In 2003, they received the designation of an American Chemical Society National Historic Chemical Landmark for their three decades of work in this area. (Sadly, they received none of the profits from these drugs as their discoveries pre-dated the Bayh-Dole Act that allowed NIH funded researchers to share in the revenues of intellectual property emerging from their work.).

Being a savvy young investigator, I sought and enlisted the assistance and support of Dr. Wall and colleagues to provide my team with world-class, natural products expertise. Stunningly, the subsequent application was awared a score of 345 (*much worse than the original) with the criticism from reviewers that all Dr. Wall did was to lend a drug development aspect to an otherwise “herbal” applicaton.

To this day, I cannot fathom who better I could have sought for natural products expertise on this grant application.

Since then, three of my colleagues and I have submitted 13 applications to NCCAM, including an application for a comprehensive Botanical Research Center grant. All 13 received unfundable scores. Among these was a 279-page application for a NCCAM Botanical Research Center – reviewed but not discussed by the evaluation panel.

Nonetheless, I have taken the approach that if NCCAM were to continue its existence, I would try to be part of the solution.  I have accepted several invitations to review research and training grants for NCCAM and I am pleased to say that one or two projects that I ranked highly ended up being very productive, specifically in the area of natural products and traditional herbal medicines.  I also have some friends and valued colleagues who contribute to the scientific integrity of NCCAM. However, my collective experiences lead me to believe that they are voices quenched by the vast wilderness of the promotion and advocacy of “integrative medicine” and CAM.
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Posted in: Basic Science, Herbs & Supplements, Politics and Regulation, Science and Medicine

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