Oh great, more "alternative medicine" funding from NIH

Just before the Nobel Prizes were announced this week, NIH posted a delightful press release on its website announcing three new Centers of Excellence in Research on Complementary and Alternative Medicine (CAM). Great! I'm so excited to hear that NIH is pouring more money down this oh-so-promising black hole of negative results and poorly conducted studies!

Now, I can just hear the CAM-fans protesting: "why are you opposed to doing studies of our methods? Are you afraid that studies will prove some of them work?" (This isn't a straw man argument, by the way - I've been asked precisely this question.) Well no, of course I'm not afraid that studies will prove that [acupuncture - homeopathy - naturopathy - Ayurveda - chiropractic - voodoo] will work. There are so many problems (with this CAM announcement) that I don't know where to begin, but one major problem is that studies have already been done, and all the results are negative. As CAM's acting director, Ruth Kirshstein, writes in her request for over $121 million for next year's CAM budget, NCCAM has supported research at more than 260 institutions over the past 7 years. Have any positive results emerged? No. Why throw good money after bad? We shouldn't.

Some of my blogosphere colleagues have already put forward some excellent arguments for why NCCAM's funding should be eliminated - see the recent post by Steven Novella, who argues:

Why can’t studies of CAM modalities be funded through the regular NIH? Because the NIH has standards, and what passes for research in the CAM world is often so laughably pathetic that it could never mean the NIH standard and get funded. NCCAM was created to provide a much lower standard for CAM research. In other words – waste money on studies that are not worth funding when judged by the usual criteria.

I couldn't have expressed it better. If this work is any good, it will get funded through the regular NIH mechanisms. Also see the comments of ScienceZoo, who points out that none of the three new CAM Centers are likely to find effective therapies for what they claim to be studying.

While I was celebrating this announcement from NIH, I couldn't help myself (I was so excited!!!) from looking at what their existing "Centers of Excellence" devote themselves to. You can find a list here, and it includes one for acupuncture (see my previous post on that topic), energy medicine (what the heck is that? I'll blog on it another time), and "mindfulness-based stress reduction" in HIV.

That last one is really rather appalling: they will investigate using meditation techniques as a way to "slow disease progression and delay the need for antiretroviral treatment." So they're going to tell HIV-positive patients to delay taking proven therapies and try meditation instead? How many patients need to die before they admit this isn't a good idea.

So you see, we have so much to celebrate this week. Three new NCCAM centers and a request for another $121 million in NCCAM funds next year. I'm so happy.

Fake acupuncture works as well as "real" acupuncture

I haven't looked at acupuncture in this space yet, but a recent study in the Archives of Internal Medicine provides some entertainment - and food for thought. The authors, Brinkhaus et al., compared the treatment of lower back pain with "real" acupuncture to two alternatives: "sham" acupuncture, in which needles are placed in random locations and inserted only superficially (not as deep), and no acupuncture at all.

The study found that both sets of patients with acupuncture reported reduced lower back pain as compared to the "no treatment" group; however, there was no difference between the real and sham treatment groups. In other words, if you thought you were getting acupuncture, you reported less pain. The authors here look at this as a victory, of sorts (and they clearly believe in acupuncture themselves - raising questions of bias in the study). It's also worth noting that one of the authors has a clear financial interest in a positive outcome - he receives fees for teaching acupuncture to professional societies; and several of the authors work at centers for complementary medicine.

I'm not surprised that the sham treatment worked as well as the "real" acupuncture. However, I don't believe that either treatment really works. As with many studies of pseudoscience, the condition (here, lower back pain) is subjective and very difficult to measure. The placebo effect is obviously at work: the patients know they had a treatment, which was a painful one, and they want to believe it was worth it. A better study would have included controls who received another treatment - massage for example - rather than nothing.

Worse yet, this study is riddled with other methodological problems. First, the physicians weren't "blinded" to the treatments. In other words, the physicians knew that they were giving real vs. sham acupuncture, introducing another source of bias. A questionnaire given to patients revealed that at least some of them figured out that they had had sham treatment.

Acupuncture has been studied countless times before (sometimes with funding from our friends at NCCAM), and the best studies show, unsurprisingly to me, that it just doesn't work. (Not surprising because there is no known physiological mechanism that would allow it to work. It's just magical thinking.) Now, although meta-analyses are highly problematic themselves, the best meta-analyses are usually the Cochrane studies, so I'll mention here that there was a Cochrane study of precisely this: "The effectiveness of acupuncture in the management of acute and chronic low back pain." You can read the abstract here. They found, after reviewing many other studies, that "there was no evidence showing acupuncture to be more effective than no treatment"; in other words, it just doesn't work.

I was interested to see that Brinkhaus et al. mentioned the Cochrane study above, but dismissed it and said that more recent studies supported their opinion that acupuncture (sham or real) is better than no treatment at all. They cited a more recent (2005) Cochrane study as one of these. But ironically (or should I say "blindly" on the part of Brinkhaus et al.?) this new study did not find evidence that acupuncture works at all. The newer Cochrane study found that almost all the studies were of low quality, and that "the data do not allow firm conclusions about the effectiveness of acupuncture for acute low-back pain." But that didn't stop Brinkhaus et al. from asserting that there is an effect. As long as they study hard-to-measure phenomena like pain, with poorly designed experiments, they'll continue to be able to find weak effects and then claim that "more research is needed."

So, if you want to enrich your local alternative healer, by all means let him stick you full of needles. But if you want to feel better, there are much more pleasant choices that won't cost you a thing.

NIH and Ayurveda, part 2

Another in my continuing series on some astonishingly stupid research funded by NCCAM, the NIH center for sham medicine (oops, I meant "alternative" medicine). This post looks at grant R21AT001969, to Cathryn Booth-Laforce at the University of Washington in Seattle, titled "Ayurvedic Center for Collaborative Research."

If you thought I'd picked out a couple of oddities in my previous posts on the pseudoscience funded by NCCAM, I'm afraid - sadly - that you're mistaken. There are plenty more examples, of which this project is just one. This project will spend thousands of your hard-earned tax dollars to set up a center for collaboration between the PI's university and a place called The Ayurvedic Trust in India, supposedly to conduct research projects. However, this nice-sounding goal ignores the fact that Ayurvedic is little more than a set of ancient superstitions, founded on ignorance and magical thinking, with no scientific merit to any of them. I recommend the article on Ayurvedic mumbo-jumbo at quackwatch.com for those who are interested.

A quick primer: in Ayurveda, all of the body's functions, including health, sickness, and so on, are regulated by three "doshas", which are really quite meaningless from a scientific point of view. For example, the dosha called vata "governs all bodily functions concerning movement" and accumulates during cold, dry, windy weather. Is there any basis for this? No. What's worse is that Ayurveda "medicines" (I have to put that word in quotes here) contain well-known toxins such as mercury, arsenic, and lead. In fact, a scientific study in the Journal of the America Medical Association (Saper et al., JAMA (2004)292:2868-2873) found:

One of 5 Ayurvedic HMPs [herbal medicine products] produced in South Asia and available in Boston South Asian grocery stores contains potentially harmful levels of lead, mercury, and/or arsenic. Users of Ayurvedic medicine may be at risk for heavy metal toxicity, and testing of Ayurvedic HMPs for toxic heavy metals should be mandatory.

What is a bit unusual about this grant is that the PI, Dr. Booth-LaForce, is a professor of nursing at a highly regarded university. Her bio reveals the source of her interest in Ayurveda: "she is studying yoga and Ayurveda-based meditation as possible therapies for menopausal symptoms." Well, I'm not exactly sure what Ayurveda-based meditation is, but I'm pretty certain it isn't science.

Ayurveda isn't medicine, and it isn't "complementary" to medicine either. NIH shouldn't fund it, no matter who the PI is. Research dollars are too precious to waste, and NCCAM should be shut down.

PLoS Biology, vanity publisher?

I'm a big fan of open access, and I'm rooting for PLoS Biology to succceed in their goal to publish papers that have the same quality and impact as Nature and Science. Today, though, I find myself both surprised and disappointed, as PLoS Biology shows that its hunger for publicity threatens to turn it into a vanity publisher.

You see, in an article appearing tomorrow morning (4 Sept 2007), PLoS Biology is publishing a paper by Craig Venter and colleagues about....(pause)... Craig Venter's genome! So when I get enough money to sequence my genome, will PLoS Biology publish that too? Is this the Donald Trump-izing of science?

But wait, you might object - maybe there's some science in the paper. Well, first you might want to recall that the original human genome paper published by Celera, in early 2001, was predominantly based on Venter's DNA, as he later admitted in a letter to Science. (Disclosure: I worked with Craig and was a co-author on the 2001 paper, and I fully stand behind it.) So most of the science was published over six years ago.

Still, I have the paper here and I've read it, and I can re-assure you that there isn't anything new, unless you are interested in how many differences there are between Craig Venter's genome and the reference human genome (the one in Genbank, which is very nearly complete). If anything, it's kind of a weirdly voyeuristic read, in which you an learn details of Craig's family history (English ancestry, three siblings, etc.), and you can see a full-page picture of his karyotype. Then there's a lengthy description of how they compared the genomes and found all the differences, but I confess I couldn't go on beyond page 10. In what I read, there wasn't much new science, certainly not of the caliber I've come to expect in PLoS Biology.

PLoS Biology will probably get plenty of attention for this paper. In politics there's a saying: any publicity is good publicity. In science, though, we think otherwise. PLoS: why'd you have to do this? I guess I shouldn't have expected so much of you.

NCCAM and homeopathy

Some of those who read this blog might wonder if there are other examples of pseudoscience and quackery supported by NIH's National Center for Complementary and Alternative Medicine (NCCAM) beyond the study on magnetic field therapy I pointed out back in June.

Unfortunately, there are lots of examples. I'm going to highlight a few more in the coming weeks, starting today. As I've written before, NCCAM is an embarrassment to NIH - it funds research that never would have made it through the rigorous review at other NIH institutes, and it is a waste of money. NIH should shut it down.

Today's example is a triple play: three grants all funded by NCCAM to the same investigator, Professor Iris Bell at the University of Arizona, who is a big fan of the homeopathy, a pseudoscience that I and many others have written critically about (see the Homeowatch site, for example).

The first one (grant R21AT003212) is called "Dilution and Succussion in Homepathic Remedy Dose-Response Patterns." This study, which should have been laughed out of the review panel, proposes to measure the effect of "succussion" on homeopathic remedies. Succussion is just shaking - you mix the stuff in, shake it up, and then dilute it. As I've explained before, homeopathic dilutions reduce the amount of "active ingredient" (usually an ingredient that doesn't provide any benefit anyway) to zero - literally so, because the dilution is so great that there is almost no chance that even a single molecule of the original substance remains, so all you have is water. Bell argues (as other homeopaths have recently) that the water retains a "memory" of the substance, and that this water still has a beneficial effect. There is no physical theory - and no evidence whatsoever - to support this claim, but there it is, right in the abstract of this grant. Dr. Bell hijacks the language of real science - clinical trials - to propose a randomized trial of various dilutions with "stirring only" versus 10, 20, or 30 succussions - that is, shakings. So NCCAM will fund a study that will compare several variants of a completely ineffective "potion." Dr. Bell isn't even going to test its effectiveness on a specific ailment - instead, she proposes to test how well subjects can "sniff" the different preparations. This is, frankly, ridiculous.

Grant number 2 to Dr. Bell is R21AT000388, "Polysomnography in Homeopathic Remedy Effects." This one will test the effects of two plant extracts on people's EEGs while sleeping (and compare them to a placebo). Both extracts will be given in 30c doses. "30c" means a dilution of 100 raised to the 30th power, or 1 followed by 60 zeros - in other words, the subjects will be given water that has a near 100% chance of containing not a single molecule of the plant extract (one of which comes from a coffee plant). The argument for using coffee is homeopathy's "Law of Similars" - that (quoting from the grant itself) "a substance that can cause symptoms in a healthy person can cure similar symptoms in a sick person." Luckily for the subjects, they won't actually get any coffee before bedtime, because the homeopathic potion won't contain any. Again, this should have been laughed out of the review panel.

Grant number 3 to Dr. Bell is 5K24AT000057 (and she has a 4th grant from NCCAM too), "Individual Differences in CAM Patient-Centered Outcomes", is already in its 8th year of funding. This doesn't have very specific aims, but instead supports "a program of research to understand the nature of global and multidimensional whole person healing patterns within homeopathy as a whole system of CAM."

None of this work should be funded with precious NIH research dollars. NCCAM undermines the credibility of all the terrific work going on in other institutes, and it drains precious funds from other studies where those funds would contribute to real science. Congress and NIH should shut it down.

Religion in the journal Nature

Kudos to Sam Harris - author of The End of Faith - for writing a letter to Nature (Nature 448, 864, 23 August 2007) criticizing the editors of Nature for their support of supernatural beliefs; i.e., religion. Harris first points out the hypocrisy in Nature's publication of an earlier opinion piece (in the July 12 issue) that argues that Islam has "an intrinsically rational world view." Ironically, the author of the earlier piece (Z. Sardar) acknowledges that "science in Muslim society has suffered a drastic decline," and he seems to genuinely believe that the Islamic religion is consistent with scientific thought, and that science can "reunit[e] reason with revelation." Harris points out that Islam - just like Christianity - regards its holy book as something that "cannot be challenged or contradicted, being the perfect word of the creator of the Universe" - which is a supremely un-scientific attitude. Harris also criticizes Nature for their favorable editorial about Francis Collins' recent book on his own personal religious (Christian) beliefs, and he includes some choice quotes pointing out how un-scientific that book is.

Harris' criticism of Nature is right on the mark. We are inundated with writing about religion, and religious people have a huge number of highly visible outlets to express their views. Religion is discussed daily in the mainstream media as well as countless specialized publications and television shows. We have a President here in the U.S. who constantly talks about religion, and he is supported by a fundamentalist movement that wants nothing more than to impose their religion on the rest of the country. Science, on the other hand, has a far smaller number of venues, and has much less of the public's attention. Scientific publications - especially those with a large readership, such as Nature - should focus on science and science policy. Harris is right when he says: "There are bridges and there are gangplanks, and it is the business of journals such as Nature to know the difference."

Or, to put it another way, the title of the journal is Nature, not Supernature. If the editors of Nature want to publish articles about supernatural phenomena, they should change the title of the journal.

Universities should support open access to literature and medicine alike

Gavin Yamey has a thought-provoking commentary over at the PLoS blog site, in which he argues that open access to the scientific literature is related to access to essential medicines. One of the points that I agree with is that our system - indeed, even the very notion - of intellectual property rights is preventing both the dissemination of knowledge and of valuable medical treatments.

We scientists publish our work primarily so that it will be disseminated as widely as possible. (Yes, I know that we also publish so that we can get promoted in our jobs, increase our funding, and other less noble goals.) To that end, open access publishing, which puts no barriers in the way of the interested reader, is the best system from the consumer's (reader's) point of view. Even more important, in many cases, is that open access publishing allows the author to retain control of the intellectual property in the article, which is logical enough since the author created it in the first place. It never made sense to me to sign over copyright to a publisher, but publisher's were able to extort these rights from authors when they controlled the means of distribution.

As Yamey points out, access to drugs is restricted in a different - but closely related - way, through patents. I've made arguments against patents before - particularly against patents on software, which I've argued should be abolished (see my editorial here). Drug patents, despite the arguments made by the pharmaceutical industry which has a huge vested interest in the current system, are "impeding the world's poor from accessing live-saving medications," says Yamey. He's right - and more than that, they encourage drugmakers to invest only in blockbuster drugs - not necessarily drugs that cure mankind's greatest ills, but those that make the most profit - and then to invest even more in legal strategies to extend their patents and prevent competition.

Where do our universities sit in this argument? Sadly, in the U.S. at least, universities have been filing 1000's of patents a year. Starting in 1980, when Congress passed a law (the Bayh-Dole Act) encouraging universities to commercialize their discoveries, the growth in university-driven efforts to protect intellectual property has been enormous. On the whole, I believe these efforts have been harmful, because they directly contradict the mission of universities - and scientists - to disseminate knowledge.

Fortunately, there is now a group, Universities Allied for Essential Medicine, that is at least making an effort to pressure some universities to recognize the harm they're doing, and to stop it. They've called on the Univ. of Wisconsin, which has an unusually aggressive licensing arm (called WARF), to demand that Abbott reintroduce a drug that they have withdrawn from Thailand over patent disputes. (WARF owns rights to the drug.) The University of British Columbia has actually drafted a new IP policy that will guarantee access to UBC inventions in the developing world (read it here).

For now, US universities are followers, not leaders. I encourage anyone in academia to pressure your administration at every opportunity to encourage free dissemination of knowledge, through open access and through rapid, unrestricted publication of discoveries - without patents. I'm trying this already at my own institute, the University of Maryland. Not surprisingly I'm meeting resistance, but I will persist, and I hope others will join me.

One thing we professors can do on our own is to halt the practice - common in some disciplines - of counting patents as publications. I've seen many resumes with patents listed, and I don't consider these to be equivalent to publications at all. For one thing, patents aren't peer-reviewed, but are reviewed by an overburdened patent office that lacks expertise in most disciplines. For another, patents are often written to conceal the true invention, so as to discourage others from trying to re-create it. Let your colleagues know that patents don't count in promotion cases, and they'll have less incentive to file them. This is just a small step, but I think it's be a step in right direction.