May 07 2009

Obama’s Health Initiative – Acupuncture for Migraine

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It must be tough being a highly visible politician – specifically taking questions from the public. You can get hit with highly technical questions in any area, often posed by someone with a narrow agenda and a great deal of information with which they can plan rhetorical mines. I don’t expect politicians to have all the technical details for any such issue at their fingertips. Experienced politicians, however, have learned how to handle such situations – the first rule of which is not to pull facts out of your butt.

George Bush’s most famous such gaffe, in my opinion, is when he said that the “jury is still out” on the question of evolution. Right – only greater than 98% of all scientists agree that evolution is a scientific fact, but we’re still waiting on the other 1% or so of hold outs.

Obama is not likely to get tripped up on the evolution issue, but he is vulnerable when it comes to science and medicine. Unscientific medical modalities and practitioners have found allies on both sides of the political aisle. The impending health care reform has also mobilized the CAM (complementary and alternative medicine) troops who are trying to twist the health care agenda to serve pseudoscience.

At a recent town meeting Obama received the following question and gave the following answer:

Q    I’m a licensed acupuncturist and licensed massage therapist in Florissant.  And so —

THE PRESIDENT:  I could use one right now.  (Laughter.)  My back is stiff.  I’ve been working hard.

Q    I’ll be happy to help you.  (Laughter.)  And this kind of fits into what you were just talking about as far as health care.  I’m wondering, as a practitioner of Oriental medicine, knowing that the National Institutes of Health and the World Health Organization has discovered through their studies that alternative medicine often is more cost-effective and very effective, how will alternative medicine fit in your new health care program?

THE PRESIDENT:  Well, look, my attitude is that we should — we should do what works.  So I think it is pretty well documented through scientific studies that acupuncture, for example, can be very helpful in relieving certain things like migraines and other ailments — or at least as effective as more intrusive interventions.

I will let the science guide me.  We just swore in an outstanding new Secretary of Health and Human Service, Kathleen Sebelius, former governor of Kansas.  (Applause.)  It’s good to see that a Jay Hawk got applause on this side of the border here. (Laughter.)  But she’s going to do an outstanding job.  And my charge to her is, as we’re going through health care reform let’s find out what works.

I think one basic principle that we know is that the more we do on the prevention side, the more we can obtain serious savings down the road.  So giving children early checkups, making sure that they get immunized, making sure that they are diagnosed if they’ve got eyesight problems, making sure that they’re taught proper nutrition to avoid a life of obesity — those are all issues that we have some control over.  And if we’re making those investments, we will save huge amounts of money in the long-term.

Unfortunately, the hardest thing to do in politics — and certainly in health care reform — has been to get policymakers to make investments early that will have long-term payoffs.  Because people — their attitude is, well, I’ll be out of office by the time that kid grows up; and, the fact that they’re healthy, that doesn’t help me.  And in the private sector insurance system, oftentimes insurers make the same calculation. Their attitude is, well, people change jobs enough for us to pay for the preventive medicine now when the problem may not crop up for another 20 years and they’ll be long out of our system, so we don’t want to reimburse it because it will make things more costly.  That’s the logic of our health care system that we’re going to have to change.

The recovery package put a huge amount in prevention.  We are, in our budget, calling for significant increases in prevention.  And my hope is, is that working in a bipartisan fashion we are going to be able to get a health care reform bill on my desk before the end of the year that will start seeing the kinds of investments that will make everybody healthier.  All right?  (Applause.)

With regard to the question – of course it is a loaded question which contains a false premise. First it treats “alternative medicine” as if it were one entity. The questioner claims that “alternative medicine works,” but this is a meaningless statement. Which CAM modalities work for which indications? Each modality has to be considered in its own right. This is precisely why the category of CAM itself is counterproductive and unscientific. It exists only to promote modalities which are not supported by science and evidence, because if they were they would not be “alternative” medicine, they would be medicine.

There is also no evidence to support the claim that any particular CAM modality is cost effective. They may be cheaper up front (but not always), but in order to be cost effective a treatment must be effective.

The bulk of Obama’s response is reasonable (from a scientific point of view – I am not commenting on his politics because that is not the focus of this blog). He says he wants to use what works and he will let science be his guide. These are both laudable principles – I hope he sticks with them.

He also did what politicians typically do, quickly steer the answer to prefab talking points, regardless of the specific question.

But he opened up by doing what seems to me throwing a bone to the questioner by stating that acupuncture works for some indications, like migraines. That, to me, was a huge gaffe, and completely unnecessary. Obama made a specific conclusion about scientific evidence in a highly technical area. I wonder if this is something he just thinks he knows because he read it somewhere, or if he was specifically told this by an adviser (in which case he needs new advisers).

At the very least it should be clear that such a claim is controversial, not accepted science. But confusion on this issue (acupuncture and migraine) is understandable given the amount of misinformation out there. Even worse than mainstream press misinformation is the fact that acupuncturists and CAM advocates are the ones doing many of the reviews, including for the Cochrane database (an evidence-based medicine database). This is a serious problem. I wonder if the Cochrane Collaboration would have pharmaceutical companies conducting reviews of the efficacy of their products.

Let’s look at the 2009 Cochrane review of acupuncture for migraine headache.  The lead reviewer is Karl Lunde whose affiliation is given as Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universitaet Muenchen. The authors of the review broke the eligible trials into three types – acupuncture compared to no intervention, acupuncture compared to standard treatment, and “true” acupuncture compared to “sham” acupuncture.

The results are not difficult to guess. The first two groups showed a benefit from acupuncture. Of course they did – these were unblinded studies. It is already well-established that most symptomatic interventions, acupuncture included, will have a perceived placebo effect, most notably for pain symptoms.

The only comparison any science-based practitioner should care about are the blinded comparisons between true and sham acupuncture, for which the reviewers found:

Fourteen trials compared a ‘true’ acupuncture intervention with a variety of sham interventions. Pooled analyses did not show a statistically significant superiority for true acupuncture for any outcome in any of the time windows, but the results of single trials varied considerably.

Right – no effect when looked at together, with lots of variability in individual trials. This is exactly the pattern we see for treatments that have no real physiological effect.

Now again – imagine a pharmaceutical company going to the FDA with this evidence for their new anti-migraine drug. The unblinded trials show a benefit over doing nothing or standard care. But the blinded placebo-controlled trials show no effect. The FDA would tell them to take a hike.

Amazingly, the Cochrane reviewers concluded:

Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.

This conclusion is simply not justified by the evidence.  This, by the way, is an excellent example of the difference between evidence-based medicine and science-based medicine. SBM considers prior-plausibility, which is low for acupuncture, and also has a greater respect for the vagaries and limitations of clinical trials. EBM, at least as practiced by Cochrane, in my opinion and that of others, puts too much faith in clinical trials.

But even according to Cochrane’s own criteria, this conclusion is not justified. The principles of EBM state that better quality evidence trumps lower quality evidence. With regard to acupuncture and migraine, the best evidence is all negative, while weaker evidence is mixed if overall positive. The best evidence (blinded controlled trials) says that there is no effect from acupuncture for migraine. That should have therefore been the conclusion of reviewers.

Here are two recent well-controlled trials as examples. This one published in the Lancet in 2006 found:

Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.

And this one published in the Clinical Journal of Pain in 2008 found:

Individualized treatment based on traditional Chinese medicine plays a role in preventing migraine attacks. Nevertheless, sham acupuncture had similar effects. Major conclusions were limited by the small sample sizes however the observed trends may contribute to design future trials.

These are the two most recent well-designed controlled trials of acupuncture and migraine – both negative with no statistically significant difference between true acupuncture and sham acupuncture. The only difference is that the authors on the 2008 paper tried to spin the results by saying that the sham acupuncture was also effective. Sorry – you don’t get to conclude that your placebo also worked (also acupuncutre proponents really like this strategy) – no difference between treatment and control means no effect.

When one cuts through the CAM spin and misinformation, the bottom line is this – the evidence shows no difference for migraine outcomes between acupuncture treatments and sham acupuncture. It’s an elaborate placebo.  There is therefore no reason to think that acupuncture has any specific role to play in migraine therapy.

Unfortunately CAM proponents have been successful in controlling the reigns of journal, academic position, and even EBM reviews of their own claims, and muscling out those pesky skeptics. They are not alone – the pharmaceutical industry tries to do this also. Recently Merck has been criticized for paying for the publication of a fake journal, made to look as if it were a legitimate peer-reviewed journal, but used to market Merck products. This is unacceptable behavior and a threat to SBM.

SBM depends upon independent science and medical academia. We are right to be vigilant against corporate intrusion into academia, and recent reforms in this area are welcome. But CAM proponents do the exact same things that they criticize in “Big Pharma.” They create newsletters and journals that are little more than marketing tools for their products and services. They infiltrate academia with big donations, trying to control the academic medical agenda and insulate their claims from skeptical scrutiny.

Science and academia have yet to fully wake up to this threat. While much deserved attention is being paid to pharmaceutical company shenannigans, CAM proponents have so far gotten a free ride.

The risk at present is that the big push for health care reform will be hijacked by those with an ideological or even corporate (although CAM corporate) agenda. Our only defense is that Obama will truly listen to the science and to scientists. Unfortunately, CAM science has already been tainted by narrow interests and ideology. The process at present is broken, and I don’t think many people realize it. Therefore Obama and his administration and likely to get misinformation when it comes to CAM, like he did with regard to acupuncture and migraines.

I am not optimistic about how this will play out.

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