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Archive for Science and Medicine

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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Science-Based Medicine Conference

My colleagues and I will be holding a Science-Based Medicine conference on Thursday, July 9th. This is an all-day conference covering topics of science and medicine. The conference is designed for both a professional and general audience.

The conference will be at the Southpoint Casino and Hotel in Las Vegas, Nevada. It is also part of The Amazing Meeting 7 (TAM7) which is run by the James Randi Educational Foundation (JREF). You can register for the conference either separately or packaged with TAM7.  You can register for both here.

Physicians can earn 6 hours of category 1 CME credits for attending the conference.

Below is the list of speakers and the titles of their talks, and below that is the bio for each speaker.

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Posted in: Medical Academia, Science and Medicine

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Lies, Damned Lies, and ‘Integrative Medicine’

Last week, two events took place in Washington that ought to inspire trepidation in the minds of all who value ethical, rational, science-based medicine and ethical, rational, biomedical research. One was the Senate Panel titled Integrative Care: A Pathway to a Healthier Nation, previously discussed by my fellow bloggers David Gorski, Peter Lipson, and Steve Novella, and also by the indefatigable Orac (here and here); the other was the ”Summit on Integrative Medicine and the Health of the Public“ convened by the Institute of Medicine (IOM) and paid for by the Bravewell Collaborative, previewed six weeks ago by fellow blogger Wally Sampson. This post will make a few additional comments about those meetings.

Senator Harkin and the Scientific Method

Thanks to Dr. Lipson, I didn’t have to listen to the Senate Panel video to find out that Senator Tom Harkin (D-Iowa) made this statement of disappointment regarding his own creation, the National Center for Complementary and Alternative Medicine (NCCAM):

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)

Are scientists at the NIH really too afraid of Harkin to explain to him how science works? Apparently so. Otherwise Harkin might learn that his statement is more wrong-headed than it would be for one of us to complain that the Supreme Court ought to assume that a defendant is guilty until proven innocent, rather than the other way around. In scientific inquiry, for those who don’t know, good experimental design is always directed at disproving a hypothesis, even one that pleases its investigator. The rest of Harkin’s sentiment—”seeking out and approving”—is incoherent.

The Selling of ‘Integrative Medicine’: Snyderman Trumps Weil

Spin doctors shilling for ‘integrative medicine,’ which the NCCAM defines as “combining treatments from conventional medicine and CAM,” appear to have now decided that subtler language is more likely to sell the product. We’ve previously seen an example offered by ‘integrative’ Mad Man Andrew Weil:

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Posted in: Medical Academia, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine, Science and the Media, Vaccines

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Prevention—science vs. nonsense

There are many ways in which cult medicine believers try to insinuate themselves into the health care system.  As Dr. Gorski has pointed out, “prevention” is one of their metaphorical feet in the door.  The cult medicine literature often says things like, “mainstream medicine is fine for treating acute illness, but what we do is prevention.” What they often leave out is the question of what “prevention” means, what the data on prevention is, and how to properly approach prevention.  It’s likely that one of my co-editors will touch on this topic in a bit more detail, but let me give you an introduction to the topic of prevention.

Definitions

Prevention is usually divided into three types: primary, secondary, and tertiary.

Primary prevention  refers to the prevention of diseases and conditions before their biological onset.  Examples of our most successful primary prevention interventions are clean water/sewerage and, ironically, vaccination.  I say “ironically” of course because so many of the altmed folks who talk about prevention are anti-vaccine.

Secondary prevention refers to the search for diseases that have not yet progressed to the point of causing overt disease, and intervening to prevent overt disease.  This  includes things like Pap smears, which look for early cervical cancers (which could have been primarily prevented by vaccination), mammography, which looks for early breast tumors,  and colonoscopy, which looks for early colonic neoplasms.  Secondary prevention is sometimes used synonymously with “screening”.

Tertiary prevention refers to the prevention of progression of and complications from existing disease.  For example, retinal and foot exams in diabetics prevent blindness and amputation very effectively.
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Posted in: Public Health, Science and Medicine

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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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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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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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Healing But Not Curing

Last week I discussed the book Healing, Hype, or Harm? edited by Edzard Ernst. I was particularly struck by one of the essays in that book: “Healing but not Curing” by Bruce Charlton, MD, a reader in evolutionary psychiatry at the Department of Psychology of the University of Newcastle upon Tyne.

Charlton proposes a new way of looking at CAM. He describes three common attitudes:

  •  CAM does good and should be integrated with orthodox medicine. 
  • CAM is worthless and should be discarded.
  •  CAM may or may not do good and this should be decided using science.

He rejects all three. In his view,

  •  Alternative therapies do good.
  •  From a strictly medical perspective they are worthless.
  •  They should not be integrated with orthodox medicine.
  •  Because they are explained non-scientifically, they cannot be evaluated using the criteria of medical science.

He suggests that alternative therapies be regarded as spiritual practices. They are about making people feel better (‘healing’) not about mending their dysfunctional brains and bodies (‘curing’). (more…)

Posted in: Science and Medicine

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