Respectful Insolence

In discussions of that bastion of what Harriet Hall (a.k.a. The SkepDoc) likes to call “tooth fairy science,” where sometimes rigorous science, sometimes not, is applied to the study of hypotheses that are utterly implausible and incredible from a basic science standpoint (such as homeopathy or reiki), the National Center of Complementary and Alternative Medicine (NCCAM), I’ve often taken Senator Tom Harkin (D-IA) to task. That’s because Senator Harkin is undeniably the father of that misbegotten beast that has sucked down over $2.5 billion of taxpayer money with nothing to show for it. It’s also because NCCAM is the brainchild of Senator Harkin, who foisted it upon the National Institutes of Health not because there was a scientific need for it or because scientists and physicians cried out for it but rather because Senator Harkin, who believed that alternative medicine had healed a friend of his, wanted it, and he used his powerful position to make it happen, first as the Office of Unconventional Therapies, then as the Office of Alternative Medicine, and finally as the behemoth of woo that we know today as NCCAM. The result has included a $30 million trial of chelation therapy in which convicted felons were listed among the investigators and a totally unethical trial of the Gonzalez therapy for pancreatic cancer. It’s not for naught that Wally Sampson called for the defunding of NCCAM, as have I and others.

Most recently, Harkin has been most disturbed by the observation that NCCAM’s trials have all been negative, going so far as to complain that NCCAM hasn’t produced any positive results showing that various alternative therapies actually work. This is, of course, not a surprise, given that vast majority of the grab bag of unrelated (and sometimes theoretically mutually exclusive) therapies are based on pseudoscience. One of the only exceptions is the study of herbal remedies, which is a perfectly respectable branch of pharmacology known as pharmacognosy. Unfortunately, as David Kroll showed, in NCCAM the legitimate science of pharmacognosy has been hijacked for purposes of woo. Meanwhile, earlier this year, Senator Harkin hosted a hearing in which Drs. Dean Ornish, Andrew Weil, Mehment Oz, and Mark Hyman (he of “functional medicine“) were invited to testify in front of the Senate. Add to that other powerful legislators, such as Representative Dan Burton (R-IN), trying to craft legislation in line with his anti-vaccine views and pressure the NIH to study various discredited hypotheses about vaccines and autism. Clearly, when it comes to quackery, there are powerful legislative forces promoting pseudoscience and studies driven by ideology rather than science.

What brought all this to mind are two very disturbing pieces of news that surfaced on Friday. They come from the opposite sides of the political spectrum. One–surprise! surprise!–involves Senator Harkin. The other involves a Republican. What they share in common is that they serve to illustrate how perilous for science-based medicine it can be when legislators try to insert their ideology into scientific studies and medical treatments funded by the federal government.

Of course, in any endeavor funded by the federal government, the insertion of some politics will be inevitable. It can’t be otherwise, and I’m not sure that it should be. Legislators who write the laws funding, for example, the NIH, the National Science Foundation (NSF), Medicare, and other federally-funded research are accountable to their constituents for how taxpayer money is spent. However, poltics and science are all too often a contentious mixture, which is why it is desirable to place as much buffers between direct involvement meddling of legislators in the science as possible. Part of the genius of how the NIH and NSF are set up is that scientists can apply for funding for virtually any project they wish to do, and their proposals will be considered seriously through careful peer review. In other words, it is scientists, not politicians and bureaucrats, who decide what work is and is not funded “in the trenches” on a day-to-day basis using the budget available. Meanwhile, elected representatives decide the overall broad picture of what is and is not funded through legislation funding various agencies and through Presidential appointment and Congressional confirmation of Directors of various agencies, such as the NIH and NSF, who then hire the leadership of these agencies and decide how they will run and what science they will emphasize. All in all, for a product of the often messy democratic process, it works pretty well, and the track record of NIH- and NSF-funded research is the envy of much of the world (well, except for NCCAM, but nobody’s perfect–and NCCAM is an excellent example of what happens when ignorant politicians insert themselves directly into the scientific funding process).

None of this stops legislators from periodically trying to insert themselves into the process even more directly by passing laws targeting specific research proposals, and DrugMonkey tells us that’s just what happened late last week through the passage of hte so-called Issa Amendment to the FY 2010 Labor, Health and Human Services and Education Appropriations bill. Specifically, Representative Darrell Issa (R-CA) offered an amendment to rescind funding for three currently funded, peer-reviewed NIH grants that that focus on HIV/AIDS prevention, and the the House of Representatives passed the amendment by voice vote, and Issa is crowing about it on his website:

“It is my mission to hold the federal government accountable for its spending and the NIH is no exception, especially during the current economic crisis” Issa said.  “These studies are clearly not high priorities for U.S. citizens, suffering from disease here at home, who could benefit from the $5 million the NIH plans to spend on foreign alcoholics and prostitutes.  We need to get the NIH’s priorities in line with those of the American people.”

Here are the grants that are targeted for de-funding through the Issa Amendment:

  • Substance Abuse Use and HIV Risk Among Thai Women (1R21 DA026324): The proposed collaboration study between Ms. Usaneya Perngparn, Chulalongkorn University, Thailand and Dr. Nemoto, Public Health Institute, California, will investigate the sociocultural contexts of HIV risk behaviors and drug use among Thai female and male-to-female transgender (kathoey) sex workers in Bangkok. Research is currently needed to develop and adapt HIV prevention models that take into account sociocultural factors so that the further transmission of HIV and sexually transmitted infections can be averted. Participation in these types of studies also can provide a way for persons suffering from the health consequences of illicit sexual activity to receive treatment while contributing to our knowledge of prevention and treatment outcomes in these populations.
  • HIV Prevention for Hospitalized Russian Alcoholics (5R01 AA016059): nvestigators are adapting a prevention approach that has been demonstrated to be effective in decreasing high-risk HIV related behaviors in the U.S. for use in Russia, a country with a rapidly expanding incidence of HIV.C2 The approach, called Health Relationships Intervention, involves the development of a plan of action for each client to increase social support and reduce high-risk behaviors. This includes the disclosure of information to family and friends on the client’s health, social needs and condition thereby assisting the client in maintaining low risk behaviors.
  • Venue-based HIV and Alcohol Use Risk Reduction Among Female Sex Workers in China (1R01 AA018090): Research has provided evidence linking alcohol-related, high risk sexual behavior with HIV and other sexually-transmitted infections. Research has also provided rich descriptions of social, cultural, and economic contexts in which people engage in alcohol-related sexual risk behaviors. More specifically, alcohol use characteristics (e.g., binge drinking) have been linked with sexual risk-taking that occurs in a range of high risk environments. The investigators have proposed a 5-year study to develop, implement, and evaluate a theory-guided, multiple components, and venue-based HIV and alcohol use risk reduction intervention among commercial sex workers (FSWs) in China.

Notice how it’s almost always about sex. In reality, what Rep. Issa objects to is almost certainly not whether or not the NIH is spending money for a study abroad; rather, it’s almost certainly that the NIH is studying ways to reduce HIV transmission in prostitutes and alcoholics, regardless of whether they are from China, Thailand, or wherever. Rest assured, if any of these studies were studying prostitutes in the good ol’ USA, Rep. Issa would be just as incensed about them. The Asian and Russian connections just lets him dollop a bit of jingoism on top of his scientific ignorance, for better effect.

As an NIH-funded researcher and a taxpayer (of quite a bit of tax), I’m very, very disturbed by this, and you as taxpayers should be too. Remember, these are grants that were submitted to the NIH for peer review. Remember that the NIH peer-review process is the gold standard. Thousands of grant applications per year are evaluated by the study sections charged with reviewing them. In the last three or four years, thanks to the flat NIH budget, which, thanks to biomedical inflation (which is higher than the base rate of inflation), has led to an actual decrease in the purchasing power of the NIH budget allocated for research gratns, as few as 10% of these new applications have been funded, depending upon the Institute. This is a drastic decline compared to the five year time period (FY 1998 to 2003) during which the NIH budget doubled. In those halcyon times, up to 25% or even somewhat more of new grant applications were funded. What this means is that the three grants that Issa is trying to de-fund were considered the cream of the crop as far as HIV/AIDS prevention. They likely had to be at least in the top 15% of grant applications reviewed. What this means is that Representative Issa is intefering with science based on ideology, not because the grants above represent bad science.

Unfortunately, studies like this are easy to ridicule if taken out of context of the broader public health effort. As Dr. Andrew Tartarsky points out:

Given that HIV/AIDS is a global epidemic that has already killed more than 25 million men, women, and children and 33 million are currently living with HIV, it is clear that prevention of HIV infection should be a priority area of research funding.

The research is easy to ridicule if it is taken out of its public health context. The fact is, scientists need to explore a range of research avenues in vulnerable populations around the world to learn the best ways to control the transmission of HIV. In response to previous congressional concerns about whether sexual health research should be funded by the agency, NIH reviewed the entire NIH sexuality portfolio in 2004.

That investigation found that all of the NIH grants in areas of sexual health met the rigorous standards of scientific and ethical quality, that they were not funded out of proportion to the public health burden of these diseases, and that the merit review system had been followed.

Efforts by politicians like Rep. Issa to meddle in the peer review process and second guess NIH peer-reviewers after the fact represent a threat to science-based medicine every bit as profound as that of Sen. Harkin’s championing of pseudoscience. If Rep. Issa can force his ideology on the NIH (and let’s face it, this is almost certainly about conservative religious views more than anything else), then what’s to stop any other Representative (of which there are 435) or Senator (of which there are 100) from doing the same thing? Nothing. It’s also profoundly demoralizing to scientists, as Drugmonkey points out:

Great isn’t it? There you are, fighting to get your project funded, surmounting the usual procedural hurdles in the grant process. Finally, you get the grant funded and can get down to the business for which you are employed- doing good science in the interests of national, nay worldwide, public health. And some politician wants to prevent further funding of your project in the middle of the award period for naked political posturing purposes. Grand.

Grand indeed.

Unfortunately, there is a long history of various legislators trying to make political hay out of NIH- and NSF-funded grants that are easy to ridicule if you don’t know the science or the broader context of the research. It frequently involves studies of sexuality, too. For example, back in 2003, then Representative Pat Toomey (R-PA, who is also now said to be planning to challenge Arlen Specter for his Pennsylvania Senate seat) tried to shut down NIH grants R01 HD043689 R03 HD039206, R01 DA013896, and R01 MH065871, all of which were focused on sexuality. (Surprise.) Fortunately, his efforts were shot down (narrowly, alas) and resulted in the formation of the Coalition to Protect Research, part of whose mission is to educate legislators on the importance of the peer review process. We can only hope that the horrible Issa Amendment is removed from the final bill passed after a House-Senate Conference Committee.

Finally, let’s not forget the late Senator William Proxmire’s (D-WI) Golden Fleece Award. Although the award often served to highlight truly wasteful government spending, all too often as collateral damage it targeted in a breathtakingly ignorant fashion scientific studies funded by various government agencies because they sounded funny to non-scientists. One researcher, after having received such an honor, went through a rather nasty ordeal:

This silliness went on for many years. The news stories began to swirl around like some kind of toxic cosmic dust. Senator Proxmire would return to Madison on a Sunday (to attend a Badgers’ football game); he’d take that opportunity to appear on a local TV show denouncing (sigh!) love research. I would be asked to reply. On Monday, one of Senator Proxmire’s comic writers would issue a devastatingly funny press release (inaccurate but beguiling) about the inanities of our love and sex research. By Tuesday morning, I’d be reeling from its aftershock. On Wednesday, the fallout would be settling in near Tokyo. Stories would appear in the Asahi Shimbun, Mainichi Shimbun, and Yomiuri Shimbun. A few weeks later, The Bangladeshi Standard‘s Geiger counters would be clicking out the news. Each time an editor in Japan, Bangladesh, or Mozambique translated the story, a name would get misspelled here, a word altered there, and the next thing you know, the Wisconsin State Journal would have picked up the challenge or comic riff yet again. The news story would be so altered and so sensationalized–by now, Dr. Hatfield, the mad doctor of love, would be caught slipping women dime bags of marijuana, asking students to confess their darkest secrets while both were doing God-knows-what in their bedrooms– that the Journal would assume that somehow they’d missed a heck of a story. Then once more the dust would start swirling around the earth, entering newer and higher orbits with each new news cycle.

I got to know the postman very well indeed as he dragged in mail by the bagful…Crazy persons’ letters, with blood curdling threats. Spiky letters, painstakingly, tremblingly constructed. Letters written in Day-Glo colors. Words marching in an orderly way across the top of the page, down the sides, and along the bottom, but then they began to sprawl in upon themselves, growing smaller and smaller as they whirled around the page. At the vortex, the microscopic calligraphy ended in a sinister inkblot. Letters filled with pain and suffering. Most people, of course, wanted to know how they could scam some of the US government’s “loot” for themselves. When they discovered they would have to dash off a grant–and actually get that grant reviewed–they were irate.

Imagine if the Internet had been as easily available in the 1970s as it is now. Oh, wait. I don’t have to. I sometimes such e-mail in droves after I post a particularly pointed attack on one woo or another.

In any case, I well remember in my youth hearing stories from Senator Proxmire of government-funded studies looking at bear sperm or some other equally ridiculous-sounding research (or so it seemed to me at the time). I’d chuckle and wonder just what those scientists were smoking. Now that I am a scientist, I realize just how toxic Senator Proxmire was when he targeted scientific studies. Fortunately, however, as far as I know Senator Proxmire never tried to insert himself directly into the NIH and NSF peer-review process by directly trying to stop one of these studies. These days, legislators are not content with just making political hay by issuing press releases and awards. They want to stop ongoing research projects.

Then there’s Senator Harkin.

I’ve already gone on a bit of a rant about how Sen. Harkin wants to hijack President Obama’s health care reform initiative in order to let alternative medicine into the range of “services” funded by any new government health plan by hiding it in the Trojan horse of “prevention” and “healthy living” initiatives. Of course, Harkin and his fellow travelers co-opt diet and exercise, both of which are science-based interventions, as somehow being “alternative” and then use them as the “foot in the door” to introduce all sorts of other “alternative” medical modalities that represent themselves as being “prevention.”

Now, it appears, that Sen. Harkin has made his desire explicit, as described in an article that appeared in the Boston Globe on Friday:

Naturopathic doctors, herbal healers, mind-body specialists, and acupuncturists often have been scorned by the US medical establishment, but growing numbers of Americans are seeking such care, and now an influential group of US senators believes the time has come to embrace an array of alternative therapies.

Senator Tom Harkin, an Iowa Democrat who is a longtime supporter of nontraditional medicine, is at the forefront of the effort to win insurance coverage for such providers as part of national healthcare legislation.
“It’s time to end the discrimination against alternative healthcare practices,” Harkin said at a congressional hearing.

Harkin is the cosponsor of an amendment that says healthcare plans will not be allowed to “discriminate” against any healthcare provider who has a license issued by a state, an amendment Senate aides said was designed to provide coverage for alternative medicine.

Here’s the language that Sen. Harkin has slipped into the 615 page Senate version of the health care reform bill:

HEALTH PROFESSIONALS.–The term “health professionals” includes–

(A) dentists, dental hygienists, primary 25 care providers, specialty physicians, nurses, nurse practitioners, physician assistants, psychologists and other behavioral and mental health professionals, social workers, physical therapists, public health professionals, clinical pharmacists, allied health professionals, chiropractors, community health workers, school nurses, certified nurse midwives, podiatrists, licensed complementary and alternative medicine providers, and integrative health practitioners;

Such a tiny passage in a huge bill!

Yet this tiny passage has potentially enormous consequences. If this part of the bill remains unchanged in whatever legislation makes it through Congress later this year then any “alternative health care provider” licensed by any state in the union will be entitled to compensation for his services from the government and health insurance companies.

What does this mean? It means nothing less than a “license,” if you will for quacks to be reimbursed by the government for their quackery. Let’s consider some examples. Acupuncturists are licensed in 44 states; so in those states acupuncturists will be able to bill the government and insurance companies for their services. Naturopaths are licensed in 15 states; so in those states naturopaths will be able to bill for their services. Combine this with recent push by naturopaths to be considered “primary care physicians,” and you can see the potential disaster looming. Remember, naturopathy is the cornucopia of woo. Many of them include in their practice supplements, acupuncture, reiki, and even homeopathy, which is considered to be within the normal scope of naturopathic practice. To them it’s all good as long as it’s “alternative.”

Now that I mention homeopathy, let’s not forget that some states actually license “homeopathic physicians,” states such as Arizona, Connecticut, and Nevada. If Harkin has his way, these homeopathic physicians will be able to bill the government and insurance plans for treating their patients with water. Of course, if this bill passes with Harkin’s amendment intact, you can then expect agitation by naturopaths and homeopaths in other states in which they are not licensed to set up licensure, so that they can equal their fellow woo practitioners fortunate enough to live in Arizona, Connecticut, or Nevada or the 14 states that license naturopaths. It would only be fair, right?

In an ideal world, scientists and physicians wouldn’t have to worry about the intrusion of non-science-based ideology into the conduct of scientific research or science-based medicine. However, we do not live in an ideal world. Someone has to fund science, and in the U.S. one major funder of biomedical and other basic research is the federal government. Charities and philanthropic organizations also fund research, but their funding is nearly always targeted far more narrowly at the causes that are the raison d’être of individual organizations. Pharmaceutical companies also fund considerable research, but their priorities are profit-driven. In other words, if a given research project doesn’t have the potential to result in a marketable drug or product, pharmaceutical companies are highly unlikely to fund it.

Which brings us back to the federal government, where support for woo is truly bipartisan:

The two main sponsors of the Senate amendment were Harkin and Senator Barbara Mikulski, a Maryland Democrat. Republicans, including the ranking member on the Senate health committee, Senator Mike Enzi of Wyoming, also backed the amendment. The Senate committee on Health, Education, Labor and Pensions agreed to the measure, but it will be left to the Senate Finance Committee, which is working on companion legislation, to write crucial language regarding potential reimbursement, Senate aides said. The matter will then be debated on the Senate floor, and a similar amendment is expected to be offered in the House.

Moreover, the problem goes far beyond just biomedical science. Any endeavor of the federal government which contains a large component based on science is fair game, be it climate policy, the environment, the space program, or others. Worse, as is the case with these others, the forces arrayed against science-based medicine tend to be well-funded, more savvy politically, and certainly more motivated than scientists are. Sen. Harkin, for example, knows that few other legislators will understand the significance of the few lines he slipped into the healthcare reform bill and few of their constituents will understand or care. The same is true of Rep. Issa regarding his naked attempt to invalidate NIH peer review. Both also know that their fellow legislators are highly unlikely to hold up such huge bills and that the President is highly unlikely to veto them over such tiny amendments. Indeed, Sen. Harkin knows that health care reform is President Obama’s signature issue and that Obama desperately wants to pass a major health care reform bill before the end of the year.

Unfortunately, as distasteful as it is, if we as physicians and scientists, along with citizens who support science-based medicine, want to stop these sorts of attempts to impose ideology-based, rather than science-based, medicine upon health care reform or even to direct our tax dollars to funding quackery and pseudoscience, we’re going to get involved in the political process. We’re going to have to contact our Senators and Representatives and tell them that we don’t want them interfering in peer review of individual competitive scientific grants and that we don’t want our taxpayer dollars going to pay for quackery. We’re also going to have to get right out front in educating the public. This is a battle that is every bit as much worth winning as that against creationism’s attacks on evolution. At the risk of annoying some of my fellow ScienceBloggers, I would argue that it is even more so because our health is directly at stake now, as is the research that will develop improved treatments for deadly diseases and chronic health issues.

Comments

  1. #1 Kismet
    July 28, 2009

    Oh no naturapaths use supplements. How evil! I think it’s pretty unfair to mention “supplements” in the same sentence as reiki or homeopathy. The latter lacks any scientific plausibility and has been even refuted by RCTs.
    Many supplements OTOH have a (or at least some) scientific backing. While much more strict regulation of supplement-quackery, dishonest advertising and manufacturing practises would be appreciated, supplements still can be part of a smart prevention regimen.
    Your tone certainly contributes to the unjustified, almost irrational fear of “supplements” I’ve seen displayed by some posters on this blog.

    Other than that great post. $2.5 billion spent and most if wasted. Ouch.

  2. #2 Chris
    July 28, 2009

    Kismet, it is because the effects of supplements are blown out of proportion, especially when mega dosing is encouraged. Also some people have been told (like a relative of mine) to dump their real medication and buy the naturapaths overpriced supplements. Apparently the supplements did not work and she went back to real meds.

  3. #3 Todd W.
    July 28, 2009

    @Kismet

    For those who have poor diets or some manner of dietary deficiency or other special dietary requirements, supplements are a reasonable treatment. For the majority of people, however, supplements don’t do squat, and for some, may even be dangerous (vitamin toxicity springs to mind).

    I agree with you wholeheartedly that the supplement industry needs much, much more oversight to ensure honest labeling and advertising, as well as making sure that supplements have consistent quality of product (i.e., that the pills actually contain what the label says they contain, that potency is uniform, etc.). Also, let’s separate supplements into new categories: vitamins and herb, the latter subject to the same requirements as drugs if any health claim is made or implied.

  4. #4 Anthro
    July 28, 2009

    Orac, I am glad to see you calling for action. I have commented numerous times here in this regard; i.e., …but what are you going to do about it?

    Harkin should have been stopped long ago, along with Weill, Oz, Chopra and their ilk. I rarely meet anyone who hasn’t been influenced by these people and most would, sadly, agree with Kismet above, even though most physicians will tell you not to waste your money on supplements beyond a “one-a-day” if you must. The alternative crowd has so convinced the general population that the American diet is devoid of nutrition (without clarifying that nutritious food IS available–in the produce section and other “outside” aisles) that supplementation has become ubiquitous. The same people that berate the pharmaceutical industry (not entirely without cause) for offering “a pill for everything”, are convinced that there is a “supplement for everything”.

    I don’t think contacting representatives is nearly enough. I have been doing this for a long time with little response other than an occasional form reply thanking me for my “interest”. Someone influential needs to have a serious talk with Harkin and try to (dare I say it?) REASON with him. The fundamental problem is education–which seems to exist on an enormous spectrum with those entering science fields professionally at one end (a tiny percentage) and the general population (who seem to have skipped over most of even eighth grade general science) at the other. Correcting that is as long-term and unlikely as achieving equal education for all children in all neighborhoods.

    I despair.

  5. #5 James Sweet
    July 28, 2009

    I’d actually like to see some legislation saying that insurance companies have to be better about covering certified nurse midwives… though saying you have to cover anything by anybody who is licensed is pretty absurd — even if it were restricted to people who should have license, i.e. no homeopaths, etc. You have to draw the line somewhere…

    @Anthro: I really liked this part of your post:

    The alternative crowd has so convinced the general population that the American diet is devoid of nutrition (without clarifying that nutritious food IS available–in the produce section and other “outside” aisles) that supplementation has become ubiquitous. The same people that berate the pharmaceutical industry (not entirely without cause) for offering “a pill for everything”, are convinced that there is a “supplement for everything”.

    I liked it because it captures so well the conundrum we are in here. Absolutely so-called “Big Pharma” is flexing their marketing muscles to promote a modality of care that is remarkably narrow and often inappropriate. Absolutely the average American’s diet is too high in processed foods and meat, and too low in fresh produce. When people become aware of this, some of them are ready to accept any alternative, without thinking critically about it.

    I guess it all comes down to partisanship being easier than critical thinking. I don’t mean partisanship in the Dem vs. Repub sense, I mean it as broadly as possible. People start to become “alternative” partisans, maybe initially because of something where the mainstream really does have it wrong, and the next thing you know they stop thinking critically and just do what everybody else on their team is doing.

    Surreal moment: I was at a local farmer’s market and ran into a couple that had recently hosted an anti-vax meeting at their house which I crashed (I usually link to my blog post about it, but I feel like I’ve spammed Orac’s blog enough, so will refrain this time). Very awkward, but it also got me thinking… in my experience, the people I know who are into alternative medicine are also more likely to be into buying local sustainably-grown produce, and vice-versa. Why the hell should those two things correlate?!? Argh…

  6. #6 Kismet
    July 28, 2009

    Todd W., Chris.
    The problem is that mentioning “supplements” in the same sentence like homeopathy and reiki, without a qualifier, implies that all supplements are always as worthless as those therapies. At least it does to a. people who are already extreme supplement sceptics (some of us) or b. people not aware of the literature.
    It is true that, contrary to what the name suggests (supplements = supplemental), the importance of supplements is greatly exaggarated by many scammers and supplement pushers. I’m also aware that unfortunately many people who take supplements actually harm themselves, but a few supplements could be used by doctors both for primary and secondary prevention and are backed up by varying levels of good evidence.
    I have to politely disagree that supplements don’t do squat for people with a good diet*. The evidence suggests that some supplements may very well help healthy individuals (be it enhancing long term health or performance). Just that any benefits are *small* and there’s necessarily educated speculation involved, because even if supplements are tested in RCTs, they’re tested in ‘at risk’ populations.

    For instance a very strong case can be made for vitamin D supplementation in the (healthy) elderly, no matter the diet*. Similar but as of yet weaker evidence suggests that vitamin D and K2 supplementation could turn out to be a net positive in the healthy population at large.

    *one of the problems is that diet is an extremely complicated topic and there’s no meaningful consensus as to what an optimal diet should look like (at least no consensus supported by RCTs). I so love to point out the unanswered questions: Probably rich in fruit. But what about dairy? Meat? Fish? Grains? Just some or a lot of it? Red or white? What about carb intake? (ornish, zone, moderate-low, keto?) What about fat? Or maybe vegan or vegetarian w/ heavy supplementation of benefical nutrients found in meat?

  7. #7 Eike Scholz
    July 28, 2009

    Wow,

    do they run the adds to specifically annoy orac and its/his readers.

    I mean “I CURED MY ACID REFLUX” followed with
    “2 simple grocery items work miracle! Doctors and drug companies
    hate this!” “… click here” is exactly the Ad I would expect …
    as a joke on Respectful Insolence. Really, I’m wondering if somebody is Joking here. ;-)

    Best Regards,
    Eike

  8. #8 Kismet
    July 28, 2009

    Maybe my english really, really sucks, but, Anthro, did you just disagree with me implying that supplement use is *exactly* as useless as homeopathy and reiki? And did you compare me to the brainwashed alt.med crowd? That’s what it sounds and I’m quite offended.

    Wow, ok, bring it on! Show us how the use of a. vitamin D in the elderly and b. vitamin K2 for vascular health is *equally* useless as homeopathy and reiki.

    To show that I’m wrong and did not justly criticise Orac for mentioning them in the same sentence, you need to prove that the use of Vit. D and Vit. K lacks any scientific plausibility and merit(because homeopathy and reiki surely does).
    You need to prove that neither of those works in vitro (1) or in animal models (2). You have to prove that neither of those works on mechanistic markers of disease (3). You also have to prove that neither of those has shown promising results in early RCTs (4). Oh, and you surely have to establish that their use is implausible. (5)

    By the way, this is not a “prove that it does not work” request. I can and will provide the necessary references to put everyone to shame who thinks that supplementation and reiki or homeopathy are *equal* bullshit (a ridiculous claim). But only later that week after I’ve finished exams… I just don’t like people talking out of their ass.

    If I understood what you said correctly (otherwise I apologise)

  9. #9 LRC
    July 28, 2009

    As a pharmacognosist and concerned scientist, I certainly feel the frustration with mis-appropriated funding that you express so vehemently. The problem was that before NCCAM, legitimate basic investigations into anything construed as “non-mainstream medicine” would simply not get funded. “Peers” will not generally stick their neck out to support an application to study an “alternative” therapy, when it is alone in a pile of 100 applications looking into more “conventional” therapies. There is virtually never any financial incentive for a company/individual to “prove” or “disprove” any traditional therapy. It is extremely difficult to protect novel means of delivering “traditional” therapies, and virtually impossible (in practice) to protect novel supplement formulations/compositions. Industry-sponsored medical studies are prioritized based on return on investment and there is basically zero motivation for the “supplements” industry to do much science, particularly when it comes to proving efficacy. The “conventional” approach to prioritizing therapeutic studies is much more market-driven than science-driven, therefore it makes sense to me that NIH should pull all those “alternative” studies into a single stack and prioritize them. These can be considered “high risk, high reward” type studies and an appropriately small portion of total NIH funding should be allocated towards them. Compared to the NIH budget overall, NCCAM’s budget is appropriately small.

    The more you learn about botanicals (as an example of an “alternative” field of medical study), the more you realize how much we have left to learn about our biochemical relationship with nature. Pharmacological investigations of natural products collectively represent a treasure trove of basic scientific understanding that has already led to 100s of pure live-saving pharmaceuticals on the market today, with thousands more waiting to be uncovered and/or developed. With all the trillion$ of taxe$ spent on medical/pharmacuetical research since 1906, FDA’s ability to completely understand/predict the pharmacology of even a PURE compound (vioxx, aspirin!), is still quite infantile compared to where we will be 100 years from now. For the past 100 odd years FDA has continuously been improving and reinventing its ability to *predict* based on all available information, whether a given substance is safe and/or efficacious. NCCAM has only been at it for 10 years, and is tasked with prioritizing the most complex pharmacological investigations (“natural products”) in addition to every quack therapy ever to have garnered a significant number of believers. In 10 years, NCCAM has already funded more basic botanical research than what the US government had funded in the previous 100 years, all the while taking incredible amounts of flak from the all-knowing.

    In these past ten years, the full spectrum from garage-based quacks to legitimate scientists at top research institutions, for the first time in the history of the world, have found an avenue to apply peer-review science to test “alternative” therapies. If you would give NCCAM a chance, you would realize that they seem to be doing EXACTLY what you clearly want: disproving sham therapies once-and-for-all and ALSO funding basic pharmacognosy research. The question of whether a given therapy has a legitimate place in modern medicine, is unrelated to the question of whether or not you happen to believe in the therapy. Should we allow scientists to sort it out using the peer-review process (i.e. stay on course and let NCCAM do its very tough job), or should we appoint someone who is all-knowing to prioritize research proposals that to most efficiently validate what is already known by the all-knowing? Or do we just scrap NCCAM altogether and stick with the current state-of-the-art “if you believe it, it probably works” philosophy?

    Taking FDA as an model of what is realistically possible in terms of UNDERSTANDING any given therapy in any given time-frame, you may want to reevaluate your assessment of what is a ‘reasonable’ amount of time to allow NCCAM to separate the wheat from the chaff. And who knows, perhaps allowing scientists to follow radically “alternative” approaches to therapeutic medicine, using modern microscopes, will lead to some breakthrough medical discoveries. I, for one, believe this is already happening. But if you are content with the current state of therapeutic medicine, then by all means stick with what works for you. You may as well move to abolish the NIH altogether.

  10. #10 Joseph C.
    July 28, 2009

    If you would give NCCAM a chance, you would realize that they seem to be doing EXACTLY what you clearly want: disproving sham therapies once-and-for-all and ALSO funding basic pharmacognosy research.

    But that’s not what has happened or will happen. Quack therapies have a seemingly infinite life no matter how many experiments fail to support them. Better run that test again. Never hurts to double check.

    Also, some modalities, like homeopathy, are so stupid and implausible that it’s embarrassing that ANY public funds have been incinerated on studying them.

  11. #11 Norwegian Shooter
    July 28, 2009

    Great stuff and a very specific call to action – if even a majority of your readers contacted all 3 of their congresspeople, it would make a difference I’m sure. So readers – do it!

    Minute point: The amount of tax you pay is irrelevant to the political process. It’s a bill and you’re expected to pay in full. The whole “as a taxpayer” bit is pernicious. Someone who pays no tax or even gets money from the Earned Income Tax Credit is your political equal. Stick to “as a citizen.”

  12. #12 Todd W.
    July 28, 2009

    @Kismet

    As I mentioned, the majority (not all) would receive no benefit from supplements. There may be some people that have some benefit from it, and, as you mention, there may be potential benefits in the elderly (I have not extensively read the literature). However, vitamin D supplements, to take one of your examples, according to NCCAM, have a higher risk of toxicity than dietary vitamin D, as well as adverse drug interactions.

    From what I’ve read, vitamins A and D are ones that pose a particular risk for hypervitaminosis, so supplements should be taken only when there is a determined need (e.g., vitamin D deficiency).

    I don’t find an issue with including them in the same sentence as homeopathy and reiki. As they are currently marketed, they are predominantly woo and many of the claims that are made for them are just as baseless as homeopathy and reiki. What really needs to happen is for them to be taken out of the realm of “alternative” medicine altogether, and possibly even make them prescription-only (I’d need to look into it more to make a definitive decision about that, though), given the potential for overdose.

  13. #13 LRC
    July 28, 2009

    quote———
    it’s embarrassing that ANY public funds have been incinerated on studying them.
    ————–

    I don’t disagree that some poor science has been funded, and NCCAM is not alone among governmental institutions in this respect. There is a cycle that starts every time Congress decides to guide science. Money grubbers who spend their time looking for easy cash are astute enough to know that any given Congressional Pile of Money (CPoM) MUST be doled out in the given FY. Meanwhile, the real scientists are busy doing science and competing for funding that they are accustomed to competing for.

    Basically, when Congress mandates that a large Pile of Money be spent on a given scientific endeavor, it will take a while before the top researchers learn of this “new” way to secure funding. I think the word is getting out about NCCAM (and I certainly encourage you to keep expousing the word! Tell every Harvard professor you know: “heres some easy cash, I am positive you will easily come up with an idea for a grant – directly related to your field of expertise- that falls into the surreal governmental bin of “complementary and alternative medicine”). If you let NCCAM run its course, you will find that top research institutions will secure a majority of its funding, which will be used to do high quality science into some of the most complex areas of study.

  14. #14 LRC
    July 28, 2009

    quote——–
    Meanwhile, the real scientists are busy doing science
    ———-

    NOT to say I agree with you that NCCAM has wasted $2.5 billion$. I would appreciate a more realistic estimate of how much money NCCAM has truly “wasted”. Throwing around the $2.5 billion$ figure with homeopathy and “nothing to show for it” is unfair. They certainly have funded some good, basic science, for example into botanicals. I encourage anyone to visit NCCAM’s website before agreeing that they have “nothing to show” for their efforts over the last 10 years. If you can honestly look over all of the 2628 abstracts of NCCAM-funded research at PubMed (http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Search&term=AT%20gr%20or%20NCCAM%20gr&doptcmdl=Abstract) and tell me that the public would be better off if NONE of those studies had been carried out, then we can honestly agree to disagree. I guarantee, in 20 years you will see [at least a few] of these publications cited (positively) in cutting edge nobel-caliber research.

  15. #15 attack_laurel
    July 29, 2009

    Urgh. The target for this kind of study-bashing is always at-risk populations, because they’re unlikely to be able to protest their treatment at the hands of politicians who think everyone could have a nice middle class life if they just hiked up their bootstraps and really tried.

    You see, it’s about making sure money isn’t wasted on those filthy hoors and junkies, because nice people never run into the same problems, right? And who cares about sex workers in Thailand – it’s not like good, upstanding red-blooded Amurrican men go over to Thailand for sex holidays and become vectors for transmissable diseases or anything like that.

    After all, why should we spend money on making the world a better place? [/sarcasm] *fume*

  16. #16 Kismet
    July 30, 2009

    LRC, they funded some good research. I think investigating Glucosamine (not necessarily chondroitin) back then was a good move based on the available evidence. The GAIT (Glucosamine/Chondroitin Arthritis Intervention Trial) was a failure for the most part and additionally it wasn’t as well designed as it should be, but it was a worthwhile endeavour.
    I think the problem is the whole philosophy of NCCAM and how they promote and investigates both implausible quackery (e.g. reiki, homeopathy) and different kinds of supplements (e.g. Vit D or K, etc) and other sensible interventions.

    @Todd W.
    I’ve only mentioned the elderly as an example, because the evidence is most conclusive when it comes to Vitamin D & elderly.
    The other example was Vit K. Basically everyone develops atheromatous plaques and vascular calcification as age they age. If Vitamin K proves to protect populations at risk (and so far it’s promising in early RCTs), it is only a small step towards using it for prevention.

    Saying that Vitamin D has a higher risk of toxicity than dietary is true, but it’s still minuscle. Risk from dietary VD is virtually non-existent and that from supplemental VD up to the UL is bordering on zero in healthy populations.

    What you have read about vitamin A & D is only partially true. Most talk about VD toxicity is greatly outdated. Vitamin D is non-toxic at intakes around the UL (meaning even somewhat higher intakes).
    See for instance this review by Vieth (1999) [1] and more recently they’ve shown that 5000IU/d (the “upper limit” is 2000IU) for one year had no detrimental effects. (2009) [2]

    What you have read basically sounds like typical Vitamin D toxicity scare mongering (if you read up on the history of Vit D toxicity research you will notice how greatly exaggerated all potential risks were from the beginning. Vieth’s review is a good start[1]).

    My point is still, that judging by the evidence (and making an educated guess), the “majority (not all)” would receive A CLEAR BENEFIT.
    It’s an educated guess, but it is a far cry from “not evidence based” or useless to the population at large and most importantly not in any way comparable to homeopathy and reiki.

    I’m definitely not alone with this “educated guess”. Read this call to action statement signed by 16 respected MDs & PHDs who are among the most prominent researches into vitamin D and some of whom have hundreds of publications in respected journals (I think that’s close enough to “worth considering” and not misinformation, right?) [3]:
    “New evidence indicates that the intake should be 2000 IU per day. Intake of 2000 IU/day is the current upper limit of the National Academy of Sciences, Institute of Medicine, Food and Nutrition Board. New evidence also indicates that the upper limit should be raised substantially. The levels that are needed to prevent a substantial proportion of cancer would also be effective in substantially reducing risk of fractures, Type I childhood diabetes and multiple sclerosis….Any risks of vitamin D inadequacy considerably exceed any risks of taking 2000 IU/day of vitamin D3, which the NAS-IOM regards as having no adverse health effect.

    A substantially higher level of support for research on the role of vitamin D for the prevention of cancer is urgently needed.”

    Your mistake is assuming that a healthy diet provides enough vitamin D and K2 and that no one is deficient. The most important source of VD is sun exposure, which promotes skin cancer as ORAC will certainly attest. While K2 is not found in so called “health foods”.

    The epidemiology clearly indicates that the majority of healthy people worldwide have insufficient or deficient vitamin D levels!
    For instance data from the US NHANES III (n=15390) “lower among…the elderly… even among White men, 34% had low vitamin D levels… Serum levels of 25(OH) D3 are below the recommended levels for a large portion of the general adult population and in most minorities. [and they're still using conservative cut-offs]” [4] And levels are lower than they used to be. [5]

    Furthermore, I’m surprised that while you concur that vitamin VD may be a problem among the elderly (and it clearly is) you still go on to say that the “majority” would not benefit. However, the elderly are making up a lot of the population and thanks to medical progress, the number of long lived individuals steadily increases…

    To put it in your own words: apparently “there is a determined need” to take vitamin D for many if not most people.

    Now some more evidence to point out just how ridiculous it is to imply or explicitely state that supplementation, including vitamin D supplementation, is *necessarily* pseudo-science. Even though it is ridiculous, quite often I’ve seen such implicit or explicit statements on this blogs and ORAC’s deragotary tone when mentioning the word “supplements” certainly contributes.

    Auntier’s meta-analysis of randomised, controlled trials (2007) [6]. A mean daily dose of 528IU decreased mortality by 7%, most studies were done in the elderly or populations at risk. Most studies also used low doses, so we cannot assess higher doses in an RCT setting.
    Epidemiological studies, however, confirm that higher intakes might be even better. LURIC [7], NHANES (general population) [8]. And some more in the elderly [9-10]
    When looking closely at the NHANES data one will see that mortality is lowest between 30-50ng/ml 25(OH)D, but between 40-50ng/ml it seems to be lower still and recent evidence indeed points to 40ng/ml being a pretty good trade-off.

    Even though it’s very unfortunate, t’s not my fault that quacks make exaggerated claims based on credible (& promising, *early*) science. Oh, BTW, Vit D is Rx only in Austria, but considering how ignorant our doctors are of the ‘vitamin d deficiency pandemic’, making it Rx only is not a good idea.

    [1]Am J Clin Nutr. 1999 May;69(5):842-56.
    Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety.
    Vieth R.
    http://www.ajcn.org/cgi/content/full/69/5/842
    [2] Am J Clin Nutr. 2009 Apr;89(4):1132-7. Epub 2009 Feb 25.
    Long-term effects of giving nursing home residents bread fortified with 125 microg (5000 IU) vitamin D(3) per daily serving.
    Mocanu V, Stitt PA, Costan AR, Voroniuc O, Zbranca E, Luca V, Vieth R.
    [3] http://www.grassrootshealth.org/documentation/scientistscall.php
    [4] Ethn Dis. 2005 Autumn;15(4 Suppl 5):S5-97-101.
    The prevalence of hypovitaminosis D among US adults: data from the NHANES III.
    Zadshir A, Tareen N, Pan D, Norris K, Martins D.
    [5] Am J Clin Nutr. 2008 Dec;88(6):1519-27.
    Serum 25-hydroxyvitamin D status of the US population: 1988-1994 compared with 2000-2004.
    Looker AC, Pfeiffer CM, Lacher DA, Schleicher RL, Picciano MF, Yetley EA.
    [6] Arch Intern Med. 2007 Sep 10;167(16):1730-7.
    Vitamin D supplementation and total mortality: a meta-analysis of randomized controlled trials.
    Autier P, Gandini S.
    [7] Arch Intern Med. 2008 Aug 11;168(15):1629-37.
    25-hydroxyvitamin D levels and the risk of mortality in the general population.
    Melamed ML, Michos ED, Post W, Astor B.
    [8]Arch Intern Med. 2008 Jun 23;168(12):1340-9.
    Independent association of low serum 25-hydroxyvitamin d and 1,25-dihydroxyvitamin d levels with all-cause and cardiovascular mortality.
    [9] Bone. 2009 Jan;44(1):168-72. Epub 2008 Apr 10.
    Contributions of 25-hydroxyvitamin D, co-morbidities and bone mass to mortality in Japanese postmenopausal women.
    Kuroda T, Shiraki M, Tanaka S, Ohta H.
    [10] Clin Endocrinol (Oxf). 2009 Feb 18. [Epub ahead of print]
    Vitamin D and mortality in older men and women.
    Pilz S, Dobnig H, Nijpels G, Heine RJ, Stehouwer CD, Snijder MB, van Dam RM, Dekker JM.Department of Internal Medicine, Division of Endocrinology and Nuclear Medicine, Medical University of Graz, Austria.

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