Science-Based Medicine

The quoted language above is part of the headline of this story in today’s The Scientist:

Citing the rising tide of Americans with Alzheimer’s—projections suggest 10 million people will be afflicted by 2050—the Obama administration and top National Institutes of Health officials are taking action. On February 7, they announced that they will add an additional $80 million to the 2013 NIH budget for the Alzheimer’s research program.

The problem is that there ain’t no such thing as a free lunch:

However, Richard Hodes, director of the NIH’s National Institute on Aging, told Nature that the 2013 dollars still have to be approved by Congress in the next budget and, if not, existing programs may need to be cut. And this year’s $50 million is likely to bump other projects, perhaps at NIH’s National Human Genome Research Institute. “If there’s a finite budget anywhere, once there’s more of something, there is less of something else,” he said.

Often such budget compromises are difficult, because there is no ready way to choose between two or more competing recipients of taxpayers’ money, each of which might be comparably worthy. Thus it is with a great sense of relief that in this case, we in the biomedical community can assure President Obama that no such dilemma exists. This is one of those occasional decisions that requires no hair-pulling whatsoever. The obvious solution is to defund the National Center for Complementary and Alternative Medicine (NCCAM), which, at about $130 million/yr, would solve the problem of funding Alzheimer’s research and take the heat off other worthy programs such as those mentioned by Richard Hodes.

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As hard as it is to believe, the Science-Based Medicine blog that you’re so eagerly reading is fast approaching its fifth anniversary of existence. The very first post here was a statement of purpose by Steve Novella on January 1, 2008, and my very first post was a somewhat rambling introduction that in retrospect is mildly embarrassing to me. It is what it is, however. The reason I mention this is because I want to take a trip down memory lane in order to follow up on one of my earliest posts for SBM, which was entitled The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work. Specifically, I want to follow up on one specific study I mentioned that was funded by NCCAM.

Even though I not-so-humbly think that, even nearly five years later, my original post is worth reading in its entirety (weighing in at only 3,394 words, it’s even rather short—for me, at least), I’ll spare you that and cut straight to the chase, the better to discuss the study. It is a study of homeopathy. Yes, in contrast to the protestations of Dr. Josephine Briggs, the current director of NCCAM, that NCCAM doesn’t fund studies of such pure pseudoscience as homeopathy anymore (although she does apparently meet with homeopaths for “balance”), prior to Dr. Briggs’ tenure NCCAM actually did fund studies of the magic water with mystical memory known as homeopathy. Two grants in particular I singled out for scorn. The principal investigator for both grants was Iris Bell, who is faculty at Andrew Weil’s center of woo at the University of Arizona. The first was an R21 grant for a project entitled Polysomnography in homeopathic remedy effects (NIH grant 1 R21 AT000388).
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Voodoo science is a sort of background noise, annoying but rarely rising to a level that seriously interferes with genuine scientific discourse… The more serious threat is to the public, which is not often in a position to judge which claims are real and which are voodoo. Those who are fortunate enough to have chosen science as a career have an obligation to inform the public about voodoo science.

– Robert L. Park, PhD, 2000¹

Imagine you are an ordinary person with limited knowledge of science and medicine, and you see this 2010 video on tai chi and qi gong by the National Center for Complementary and Alternative Medicine (NCCAM) — one of the agencies that make up the National Institutes of Health (NIH). I am certain that the solemn voice of the Director of NCCAM, Dr. Josephine Briggs, talking about “rigorous scientific research” and “accurate, authoritative information on complementary and alternative medicine,” will leave you with a strong sense of confidence in her message.

In addition, despite the fine-print and the disclaimer, the appearance of Dr. Briggs in the video could be broadly viewed as a sign of tacit endorsement. Often, the very fact that a treatment is associated with the government is already a de facto stamp of approval and a warranty of efficacy. For instance, the publication below by the California Department of Consumer Affairs states that the NIH formally “endorses” acupuncture, simply because in 1997, a panel of scientists assessed its use and effectiveness for a variety of conditions. Since 1997 the scientific review of acupuncture by NIH has become synonymous with its endorsement, despite the fact that as a federal research agency, the NIH does not endorse any product, service, or treatment.

In October 26, 2011, a few weeks after Steve Jobs’ death, Josephine Briggs decided to do something she has never done before: she put an explicit disclaimer on her blog:

When making treatment decisions, unproven “alternative medicine” approaches should not replace conventional medical care approaches known to be useful or helpful. Simply put, the evidence is not there (emphasis added).²

Three paragraphs down the page, she goes on — with a candor rarely seen from her — that given the recent news about Steve Jobs’ choices for cancer treatment, all health decisions “should be guided by the best available evidence.”
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On Friday, one of my partners in crime here at Science-Based Medicine, Dr. Kimball Atwood, wrote an excellent Open Letter to Dr. Josephine Briggs. Dr. Briggs, as most regular readers of SBM know, is the Director of the National Center for Complementary and Alternative Medicine (NCCAM). As most regular readers of SBM also know, we at SBM have been quite critical of NCCAM for its funding of studies of dubious scientific value, including one that I mentioned quite early on in the history of this blog, in which an R21 grant was awarded to investigators at the University of Arizona for a project entitled Dilution and succussion in homeopathic remedy dose-response patterns. The purpose of this project was to compare the effectiveness of a homeopathic remedy at different dilutions. It even compared remedies that are succussed (vigorously shaken) at each dilution step against remedies that were merely stirred. Although this is merely the most egregious example I could find at the time, two years ago I did catalog many more examples, as well as the “educational” grants disbursed through NCCAM in order to teach (and, by doing so, promote) CAM.

Given NCCAM’s long history of promoting pseudoscience, we were all quite surprised when early this year we received an e-mail from Dr. Briggs herself inviting us to NCCAM to meet with her. Unfortunately, due to our work obligations, Steve Novella, Kimball Atwood, and I were not able to coordinate our schedules to travel to Bethesda and enter the heart of darkness itself until early April. Our conversation with Dr. Briggs and her staff was cordial and mutually respectful, as Steve Novella described, and we assured her that we understood that studies such as the one I mentioned above were funded before her tenure. At the same time we were a bit disappointed that Dr. Briggs appeared far too eager to dismiss such problems as being before her time. Still, we understood and approved of Dr. Briggs’ stated goal of making NCCAM more scientifically rigorous, even though we did point out that there is nothing done at NCCAM that couldn’t be done as well in the NIH’s structure before NCCAM existed.

Unfortunately, not too long before or after Dr. Briggs met with us, she also met with a group of homeopaths, leading us to worry that perhaps in her quest to appear “open-minded,” Dr. Briggs was being so open-minded that her brain was in acute danger of falling out, particularly after we saw her infamous “science must be neutral” director’s newsletter a month later, which Dr. Kimball skewered as part of his open letter and I recently used as an example of misinterpreting what scientific “neutrality” means during my talk at the SBM Workshop at TAM8 a couple of weeks ago. In fact, I now wonder if I missed a little gray matter oozing out of Dr. Briggs’ ears during the meeting even though I sat right next to her.

Unfortunately, Dr. Atwood’s open letter gives me even more reason to despair, because in it he pointed out that Dr. Briggs will be speaking at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP) from August 11-15 in Portland, OR. (One wonders if Mark Crislip would be willing to make an appearance there for a Very Special Episode of his Quackcast and thereby continue to expand his Internet empire. I realize that doing so would really be “taking one for the team,” but think of the blogging and podcast material!) Kimball’s explanation why this is disturbing is excellent and detailed, as usual, but one thing he didn’t do as much of as I would have is to go into a bit more detail of what sorts of dubious medical modalities and even outright quackery Dr. Briggs will be associating herself with by speaking at this particular convention. He probably didn’t feel the need, given that he referenced his two comprehensive deconstructions of the quackery that is naturopathy, but I’m not as well-versed in naturopathy as he is, and, I suspect, neither are you. Dr. Atwood didn’t need to delve into the woo that will be presented at the AANP. I do. That’s why I thought a bit of a survey of what will be presented at the conference was in order.
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The demographic of SBM readers are likely to remember the early Miller Lite beer television commercials where sports personalities debated as to whether the beverage “tastes great” or was “less filling.” In one classic version, New York Mets’ Marv Throneberry breaks the shouting match to level his decision: “I feel strongly both ways.”

My colleagues at Science-Based Medicine have generally been opposed completely to the existence of the NIH’s National Center for Complementary and Alternative Medicine (NCCAM). The primary objection is that the Center awards roughly $125 million per year in taxpayer dollars to studies that are generally not based on a strong scientific foundation or, in some cases, absolutely no scientific basis. On the other hand, the best NCCAM-supported studies have provided fruitful results, if not negative with regard to clinical outcomes.

The recent series of articles by Trine Tsouderos at the Chicago Tribune (1, 2, 3, 4) has reignited a national debate as to whether NCCAM is needed at all. After all, NCCAM was not because of science but because of politics, particularly the efforts of Senator Tom Harkin and Representative Dan Burton. And other NIH institutes, such as the National Cancer Institute, seem to do a much more rigorous and science-based job of funding studies of alternative cancer therapies through their unfortunately-named Office of Cancer Complementary and Alternative Medicine, or OCCAM.

In fact, I have long argued that if alternative therapies are to be investigated rigorously, they should be done so under each of the specific NIH institutes and centers (ICs) that have been established to focus on organ systems (National Institute of Diabetes and Digestive and Kidney Diseases; NIDDK) or a class of related disorders (National Institute on Drug Abuse; NIDA).

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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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“Complementary and alternative medicine,” as pediatrician and fellow blogger John Snyder aptly stated in a recent journal article on CAM and children,

is a term used to describe a disparate, poorly defined set of practices and treatment modalities presumed to be distinct from so-called ‘conventional medicine’.

As we have discussed here at Science-Based Medicine, this amorphous concept facilitates a convenient fluidity in delineating the parameters of CAM. Without a clear definition, CAM (and integrative medicine) proponents are able to rebrand plausible and evidence-based practices such as diet, exercise and relaxation as CAM, a tactic we at SBM call “bait and switch.” This results in inflation in the figures of CAM use (important because CAM is all about popularity) and claims that CAM “works.”

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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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…and in so doing, President Obama, you and we would abolish the NIH’s second most prodigious squanderer of precious research funds! Surprise: The National Cancer Institute (NCI) spends slightly more on humbug than does the Center created for that purpose. All told, the NIH squanders almost 1/3 of a billion dollars per year promoting pseudoscience.

I’ve decided to add my two cents to the recent groundswell of demand to stop this sordid and embarrassing chapter in NIH history—even more sordid and embarrassing, in its way, than NIH researchers being on the take: pseudoscience is exactly antithetical to the mission of the NIH, which sponsors it repeatedly, officially, overtly, unethically, and dangerously. At least, in the case of Big Pharma greasing the palms of NIH researchers, those involved generally prefer to obscure the transactions, as good sense and traditional mores dictate.

My comments will be somewhat different from others’, not because I disagree with theirs but because it’s worthwhile to stress points that have not been stressed or even mentioned. I won’t bother to justify the assertion that “promoting pseudoscience” is an accurate description of what the NCCAM and the OCCAM do, because I’ve done that several times in the past, beginning here and here, and more recently here. I will plagiarize myself a bit, but only to introduce certain points.

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The National Center for Complementary and Alternative Medicine (NCCAM) is a government agency tasked with (among other things), “[exploring] complementary and alternative healing practices in the context of rigorous science.” In this space we have talked about NCCAM quite a bit, but I have to admit that I don’t think about them very much. The other day, though, I was reading though JAMA and I came across a study funded by the agency. The study, which showed that Ginkgo does not prevent Alzheimer’s-type dementia, was pretty good, so I cruised on over to NCCAM’s website to see what else they’ve been up to.

A quick glance at NCCAM’s front page:

“Ginkgo Evaluation of Memory (GEM) Study Fails To Show Benefit in Preventing Dementia in the Elderly”

“CAM and Hepatitis C: A Focus on Herbal Supplements ‘No CAM treatment has yet been proven effective for treating hepatitis C or its complications.’”

“Selenium and Vitamin E in Prostate Cancer Prevention Study, ‘selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer.’”

It seems that NCCAM is finding out something we already strongly suspected:  improbable medical claims are usually wrong.  Since that’s not how they see things,  and since I don’t believe that there is such a thing as alternative medicine, I was curious how they defined CAM.

CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. Conventional medicine is medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses. Some health care providers practice both CAM and conventional medicine. While some scientific evidence exists regarding some CAM therapies, for most there are key questions that are yet to be answered through well-designed scientific studies–questions such as whether these therapies are safe and whether they work for the diseases or medical conditions for which they are used.

The list of what is considered to be CAM changes continually, as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge. emphasis mine, ed.

The list of NCCAM studies appears to fall into three broad categories.

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