You didn't think this one would go by without my commenting on it, did you? Even though Abel and Tara have already ably commented on it, I can't help but jump in because the article echoes one of the common threads of this blog since the very beginning. Besides, as I've said before, just because everyone else has already commented on an article or issue never stopped me from jumping in before (well, almost never, anyway).
The article in question, Ignoring the failures of alternative medicine, is remarkable (to me, at least) because I can't recall any major media outlet like MSNBC daring to speak ill of the alternative medicine industry or the National Center for Complementary and Alternative Medicine in a long time. The operating assumption in the media and much of the U.S. is that we should give credence to the claims of alternative medicine, no matter how unlikely. Reiki therapy, homeopathy, it doesn't matter. No matter how scientifically implausible, we skeptics are castigated if we don't take non-evidence-based woo seriously.
That's why what makes this article by Robert Bazell, Chief Science and Health Correspondent for NBC News, all the more surprising:
Call it swimming against the tide of alternative medicine. It is a futile effort costing taxpayers tens of millions of dollars a year.Last week's study showing that the widely touted and sold supplement DHEA does nothing to slow the effects of aging was only the latest major piece of research with powerfully negative results from the National Institutes of Health Center for Complimentary and Alternative Medicine. Previous placebo-controlled trials proved the uselessness of St. John's Wort for depression and saw palmetto for enlarged prostates, shark cartilage for cancer, echinacea for the common cold and glucosamine plus chondroitin sulphate for arthritis.
But it doesn't matter much -- few seem to care.
Indeed few do. Anyone who's hung out on this blog for a while will rapidly come to realize that. Whenever I critically look at this or that alternative therapy and conclude that there's no evidence that it works and no good reason to suspect that it should, almost inevitably I'll get an objection by someone who claims that it "worked" for him or her. Whenever I decry, for example, the altie woo and magical thinking that have led youngsters like Katie Wernecke or Starchild Abraham Cherrix away from evidence-based therapies that actually have a reasonable shot of curing them of their cancer, it nearly always brings some angry comments, no matter how much I try to be fair and objective. When I point out that chelation therapy does nothing for autism because the available evidence strongly contradicts the hypothesis that mercury in vaccines causes autism, I can usually expect to be assailed by the mercury militia, who fervently believe that it does. And whenever I start pointing out the nonsense pushed by antivaccination activists, most of whom have fallen for concepts in alternative medicine that vaccines somehow "hurt" the immune system or that bacteria and viruses don't really cause the diseases that science tells us they cause, or that "natural" immunity is somehow "better" than immunity from a vaccine, I can usually count on being deluged by angry comments.
As Bazell puts it:
The NIH launched its office of Complementary and Alternative Medicine (CAM) in 1991 in response to the public's huge interest in finding ways around mainstream medicine. At first, those heading the effort brought dubious credentials. Much of the research ranged from mediocre (meaningless animal studies) to laughable (passing magnets over sore knees).
But, in 1999, with the name changed to the National Center for CAM, Dr. Stephen E. Straus took over. Straus, who spent much of his career at the National Institute on Allergy and Infectious Diseases, enjoys a reputation as an accomplished scientist. In his time as director, the Center for CAM has spent much of its $122 million annual budget on clinical trials putting most popular alternative treatments to the same rigorous tests as those required of pharmaceuticals and medical devices before approval by the Food and Drug Administration.
Except for acupuncture, already proven effective in China, almost all the research has come to the same conclusion: the stuff doesn't work.
Actually, if there's good evidence out there that acupuncture actually works the way its adherents claim it does (you know, with accupoints, meridians, and altering the flow of qi, and all that stuff), given that sticking needles in areas not considered to be accupoints or on proper meridians (or sticking needles almost anywhere) seems to cause the same effect, which is most likely part placebo, part distraction, I'd be interested. Sticking needles in the skin may somehow relieve pain, but I would argue that all that altie stuff about qi and meridians as an explanation for how acupuncture "works" is nothing more than a lot of mystical hokum that only prevents us from understanding why sticking needles almost anywhere in the skin might relieve pain or treat other problems. I saw this most pointedly in a grant was discussed at the last NIH study section meeting I participated in that proposed to measure qi. But I digress.
Bethell is correct that virtually every study funded by NCCAM whose results have been reported lately has been a negative study, even though NCCAM's budget has risen to $122 million a year since its origins in 1993. He's also correct in pointing out that it doesn't matter. Big altie is on the way to becoming as powerful and influential as big pharma. Alternative medicines and supplements have together grown into a $29 billion industry, and, as I pointed out before, it's a very profitable industry, given that, unlike big pharma, these companies don't even have to make a pretense of producing evidence that their therapies work:
Marketers often sell them under the guise of a mom-and-pop alternative to big pharma. Yet the $29 billion-a-year dietary supplement industry wields such power that it got Congress to pass a law in 1994 that basically frees it to peddle almost anything that doesn't kill people with claims of medical benefit that need not be proven.
No doubt some of the thousands of products sold as dietary supplements work well, but the industry that sells them has neither motivation nor desire to know which ones work and which don't.
No doubt? Actually there's a lot of doubt that some of the thousands of dietary supplements "work well" (whatever that means). In fact, all you have to do is to tack a "this product has not been evaluated by the FDA, so consult your doctor"-type disclaimer and you can sell your supplements. But I particularly like the way Bazell takes Andrew Weil to task:
On his Web site someone recently inquired if a supplement called NT was useful for fatigue. "I'm not convinced by the scant literature on the subject that there's anything to recommend taking NT Factor for fatigue," Dr. Weil replied, in a surprisingly forthright response.
But, then he added that the fatigue sufferer might want to try "Siberian ginseng (Eleutherococcus senticosus), coenzyme Q10, the Ayurvedic herb ashwaganda or cordyceps, a traditional Chinese medicinal mushroom that may help fight fatigue and boost energy levels."
I can find no evidence that any of these relieve fatigue any better than NT.
It gets better.
Dr. Weill concluded his answer by advising that a better-studied treatment might be something called Juvenon. At the bottom of the Web page appeared an ad from the manufacturer of Juvenon with the quote "I take Juvenon every day -- Dr. Andrew Weil."
Such crass commercialism would put most big drug companies to shame.
I hope Bazell has his asbestos suit on, because I predict that he's going to get flamed by readers. In any case, that was exactly my point the last time I addressed this. Alties view their favored woo as being somehow "above" commerce when it is anything but that and when its sellers are starting to behave more and more like traditional pharmaceutical companies, including indulging in the same sort of promotional excesses of dubious ethics.
So what should be done? Here, I diverge with Tara, who says:
Unfortunately, what Bazell leaves out are suggestions about what to do now. Close down NCCAM altogether and immediately? We have a serious catch-22 here. We do want studies done on these "alternative" medicines, so we can justify saying they're crap (or, be surprised when they actually work). But the problem is, as mentioned, that for the companies that make them, it doesn't matter if they work--they can market them anyway, even if they're no better than a sugar pill placebo. This loophole needs to be closed before any serious reform can be made to NCCAM--and that's not going to be a politically popular arena to step into.
True enough, and Tara's opinion is the way I used to think about this topic. Now, however, I'm no longer so convinced that NCCAM is a good idea anymore. NCCAM has had 14 years (with seven years of generous funding) to show some concrete results and has for the most part failed. Although I used to support NCCAM and its mission because I viewed NCCAM as the best way to apply the scientific method to the claims of alternative medicine, a goal that I still support strongly, I no longer see a compelling need for the existence as a separate Center in the NIH to achieve this goal. For one thing, NCCAM does nothing that can't be done as well--or, in most cases, better--by other NIH Institutes and Centers. For another thing NCCAM is completely a political and ideological entity, not an Institute based on a sound scientific rationale. Indeed, it is the only center or Institute in the NIH that is based on ideology, rather than a category of disease, an organ system, or a type of medicine. I have now reluctantly come to the conclusion that there is not, and never has been, a compelling scientific reason why alternative medicine should be treated any differently from conventional medicine in terms of basic and clinical research. Indeed, the very existence of NCCAM as a separate entity, I would argue, fosters an attitude both within the Center and in Congress that alternative medicine should somehow be treated differently, as separate from, conventional medicine. In practice, this attitude seems to lead to the attitude that alternative medicine should be treated less rigorously, that it should be "cut some slack," as evidenced by some of the dubious trials being conducted on the basis of poor to nonexistent preliminary data, examples of which include the NCCAM trial on chelation therapy for cardiovascular disease, whose study sites has included a bunch of dubious altie clinics as sites and whose design appears not to provide for adequate blinding of the double-blind trial and the $1.4 million trial testing the Gonzalez protocol, a a strange treatment involving pancreatic enzymes, coffee enemas, and up to 150 dietary supplements a day.
Of course, what I do acknowledge, as Tara does, that it would be politically unpopular to bring real reform to NCCAM to make its output more scientific or to eliminate it altogether and fold its activities into the relevant Institutes of the NIH. Such radical surgery on the Center is unlikely in the extreme. One reason is that NCCAM has powerful defenders and advocates, like Senator Tom Harkin (D-Iowa) and Congressman Dan Burton (R-Indiana), the latter of whom pressured NCCAM into funding the aforementioned study of the Gonzalez protocol in pancreatic cancer despite its lack of scientific merit. (It's a study for which even Dr. Stephen Straus, Director of NCCAM, has never been able to offer more than a lukewarm endorsement and defense.) Perhaps the more important reason, however, is that people really like their woo. Applying rigorous science to it will almost certainly result in the vast majority of alternative medicine "treatments," particularly ones that either don't involve herbal medicines (many of which, after all, contain active pharmaceuticals) or that involve in essence religious concepts like energy healing, failing to show efficacy when compared to conventional medicine. When faced with the likelihood of negative evidence, alties tend to prefer a lack of evidence, which allows them to continue to argue that science hasn't "disproven" their favorite alternative medicine. Of course, negative trials are useful to physicians, who can with confidence cite them as evidence that some woo or other doesn't work better than placebo, but unless they're used to drive policy (for example, forbidding claims of supplement efficacy that aren't backed up by science), they serve little purpose.
Wait! You mean the same Dan Burton that thinks that mercury causes autism is also a big supporter of NCCAM? I wonder if one has anything to do with the other...nah! We all know alties don't have the money to influence legislators.
In any event, NCCAM is a big fat joke and a waste of money that could be used to do studies on things that could actually help people.
While I realize that it is only something you quoted (vs something you wrote), I'll take you to task for the same thing for which I took Tara to task - Glucosamine probably doesn't belong to the 'altie' category. There are a lot of stat sig randomized trials and studies - run by reputable orgs and published in reputable magazine (e.g. JAMA). Even the 'failed' study that it probably being referenced in the quote was not a significant a failure:
p=0.09 on the primary endpoint for Glucosamine plus Chondroitin. May not be technically 'stat sig', but as one statistician recently bemoaned in a published article, the medical community and lay press both think that 0.05 is some kind of mystical number. 0.09 means it is 4.5% chance that they got this result by chance.
(And note that the 'failed' study protocol was a pretty stupid one given the type of success seen in multiple previous studies - in general the successful trials have been long ones (3 years), whereas the 'failed' trial was 24 weeks.)
Do you suppose that if the US had a decent medical program, these people would use it, instead of these alternatives, which may be all they can afford?
Big Al,
Alternative medicine is not cheap. Chiropractic care costs thousands of bucks for "maintenance" sessions. Some of these herbal remedies and dietary supplements can run hundreds of dollars a month or more. (more in some cases than prescription medicine)
The reason people bail on mainstream medicine has far less to do with cost than it does either a distrust of doctors or a bad previous experience. Alties prey on that, as well as on the things that mainstream medicine can't do a whole lot about. (chronic conditions, mostly) While I agree medical care in the U.S. isn't spectacular, I disagree that it plays a particularly large role in the use of alternative medicine - and I'd defy you to find a correlation between quality of medical care and use of woo anywhere in the world.
I live in Dan Burton's district, and have had a number of written exchanges with him. He's an insurance saleman, not a lawyer, so he has even less experience with evidence-based anything than your run-of-the-mill pol.
He also has a grandson who is autistic.
Burton is a True Believer, not (in this case at least)someone bought by Big Supplements. Eli Lilly and Company is also in his district, so were he to have been bought....
Just FYI, the chairman of the relevant House committee in 1994, when "nutritional supplements" were exempted from FDA regulation, was Henry Waxman (D - California, IIRC.)
fusilier
James 2:24
Orac wrote:
Wonderful — God bless the free market!
Now, seriously folks, won't it be great when we can accuse anti-vaccination loons of being Big Altie Shills?
Big Al -
No. Here in the good old UK, even with the NHS, people will go off and spend cash on 'alternative' 'treatments'. There is a case in my local area of a 11-year old with cancer whose parents have spent tens of thousands of pounds trying every treatment available. Next one is some sort of fetal stem cell therapy, a snip at £14k.
http://tinyurl.com/yfbcfa
The reason being, I expect, that 'alternative' practicioners will never give up on a patient as long as the cheques don't bounce. Even if there is absolutely no chance of their treatment actually doing anything.
And when these treatments cost tens of thousands of pounds and mean that the patient spends what time they have left on a diet of juice and raw vegtables, they cannot be described as 'harmless'.
Big Al -
No. Here in the good old UK, even with the NHS, people will go off and spend cash on 'alternative' 'treatments'. There is a case in my local area of a 11-year old with cancer whose parents have spent tens of thousands of pounds trying every treatment available. Next one is some sort of fetal stem cell therapy, a snip at £14k.
http://tinyurl.com/yfbcfa
The reason being, I expect, that 'alternative' practicioners will never give up on a patient as long as the cheques don't bounce. Even if there is absolutely no chance of their treatment actually doing anything.
And when these treatments cost tens of thousands of pounds and mean that the patient spends what time they have left on a diet of juice and raw vegtables, they cannot be described as 'harmless'.
Instead of Big Supplement, how about Mega Vitamin? Gives it the right B-horror movie flavor.
It's not just the US system: I live in Ontario, and I've had three different friends turn (partially) to altie-type therapies. Apropos of someone else's comment, two of them have chronic conditions (Lupus and Crone's respectively) for which mainstream therapy is only partially effective and/or brings unpleasant side effects.
What makes it even more ironic is when the alties cheat by adding sildenafil!
frees it to peddle almost anything that doesn't kill people
Or even if it does. Kava kava root anybody? Or ephedra? Or smokers taking high dose vitamins that actually increase their risk of cancer?
While I sort of agree with you that the studies done by NCCAM could just as easily be done by the relevant institutes (ie St. John's Wort with NIMH or glucosamine with NIA), since doing otherwise implies that altie cures are subject to different rules, lemme play devil's advocate for a sec:
Once the "real" institutes started doing altie studies, there's be continual political pressure for each institute to "balance" the altie studies with conventional ones. Not only would we wind up wasting even more money, but it would put the institutes in a position where they'd wind up having to delay studies that could actually improve or save lives to make room for worthless crap.
Of course, NCCAM already competes with the other institutes for funding, but at least the current setup allows sympathetic legislators to add funding directly to NCCAM without necessarily siphoning it away from other projects.
NCCAM funding doesn't bother me all that much, though; it gives us good data regardless of whether failed studies change anyone's mind. What really gets me is the extent to which the enormous waste of resources on altie treatments plus the cost of delayed treatment adds inefficiency to the system and contributes to rising healthcare costs across the board.
Henry Waxman is also the jerk responsible for stopping the subway to the beach in Los Angeles. Please, if you live in his district, throw the idiot out on his ass. If you need a little inspiration, just drive from Venice Beach to downtown in rush hour traffic on a Friday night.
Hyperion makes some interesting points. However, NCCAM came about because alties can't compete for funding in the NIH at large. If one did write a rational, well-supported proposal; sure put it through regular channels. However, I doubt any project supported by NCCAM would ever pass muster.
There is also a human element to consider. Orac mentioned the "Gonzalez therapy" for pancreatic cancer. Patients see Gonzalez has NIH backing and think his work is legitimate, and many people enroll. This disease kills 50% of its victims within six months of diagnosis. Gonzalez' protocol assures that their last months are miserable. They are not allowed any palliative therapy.
No, it doesn't.
Indeed, it doesn't. I was going to chime in, but Martin beat me to it.
Nevertheless Clark's basic point is sound. Ultimately the line must be drawn somewhere, but its always worth allowing for some border country. When I'm running tests for statisitcal significance (for the record I'm an econometrician) I use the normal standard of p < 0.05, but if the p-value lies between 0.05 and 0.1 I don't dismiss a correlative link out of hand. I certainly wouldn't drop a variable from a model with a p-value of less than 0.1 wihout some additonal reason.
He's got half a point, maybe, but it cuts in the other direction. 2 sigma is a crappy standard. It's only tolerated because in many fields it's the only way to actually get any work done. One always has to balance the costs of type I and II errors, and in fields like medicine the cost is measured in lives. Would be nice if the standard was 6 sigma, but it's just not an option in the real world.
p=0.09 does not translate to "not a significant failure."
p=0.09 could mean one of two things. Either the trial was too small and a larger one needs to be done or there was no effect worth talking about. Without seeing the actual data, it's hard to say which it is. Personally, I consider anything with p-value of greater than 0.01 to be marginally signficiant at best, though I admit to having published claims of signficance on p-values of 0.01-0.05. But generally only when it's not practical to get more samples and determine if the value goes up or down.
I insist on at least two zeroes between the decimal point and the one myself. I refuse to accept 0.05 as anything other than a strong indication that something shows real promise.
I also reject (or at least am extremely wary about) anything for which any more than one investigator reveals any more than the most tenuous ties to the pharmaceutical company whose drug they have proved works.