Science-Based Medicine

BACKGROUND: A BAD, BAD LAW

One of the themes of this blog has been how, over the last couple of decades, the law has been coopted by forces supporting “complementary and alternative” medicine (CAM) in order to lend legitimacy to unscientific and even pseudoscientific medical nonsense. Whether it be $120 million a year being spent for the National Center for Complementary and Alternative Medicine (NCCAM) or attempts to insert provisions mandating that insurers in the government health care co-ops that would have been created by President Obama’s recent health care reform initiative (which at the moment seems to be pining for the fjords, so to speak), the forces who do not want pesky things like regulation to interfere with their selling of pseudoscience have been very successful. Arguably the crown jewel of their legislative victories came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Demonstrating that pseudoscience is a bipartisan affair, the DSHEA was passed, thanks to a big push from the man who is arguably the most powerful supporter of quackery in government and the man most responsible for the creation of the abomination that is NCCAM, Senator Tom Harkin (D-IA), along with his partner in woo, Senator Orrin Hatch (R-UT). It should be noted that Harkin happens to be the recipient of large contributions from supplement manufacturer Herbalife, demonstrating that big pharma isn’t the only industry that can buy legislation related to health.

Dr. Lipson has discussed the DSHEA before (calling it, in his own inimitable fashion, a “travesty of a mockery of a sham“) as has a certain friend of mine. Suffice it to say that the DSHEA of 1994 is a very bad law. One thing it does is to make a distinction between food and medicine. While on its surface this is a reasonable distinction (after all, it wouldn’t make a lot of sense to hold food to the same sorts of standards to which drugs are held), as implemented by the DSHEA this distinction has a pernicious effect in that it allows manufacturers to label all sorts of botanicals, many of which with pharmacological activity, as “supplements,” and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing:
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“Ridiculing RCTs and EBM”

Last week Val Jones posted a short piece on her BetterHealth blog in which she expressed her appreciation for a well-known spoof that had appeared in the British Medical Journal (BMJ) in 2003:

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

Dr. Val included the spoof’s abstract in her post linked above. The parachute article was intended to be humorous, and it was. It was a satire, of course. Its point was to call attention to excesses associated with the Evidence-Based Medicine (EBM) movement, especially the claim that in the absence of randomized, controlled trials (RCTs), it is not possible to comment upon the safety or effectiveness of a treatment—other than to declare the treatment unproven.

A thoughtful blogger who goes by the pseudonym Laika Spoetnik took issue both with Val’s short post and with the parachute article itself, in a post entitled #NotSoFunny – Ridiculing RCTs and EBM.

Laika, whose real name is Jacqueline, identifies herself as a PhD biologist whose “work is split 75%-25% between two jobs: one as a clinical librarian in the Medical Library and one as a Trial Search Coordinator (TSC) for the Dutch Cochrane Centre.” In her post she recalled an experience that would make anyone’s blood boil:

I remember it well. As a young researcher I presented my findings in one of my first talks, at the end of which the chair killed my work with a remark that made the whole room of scientists laugh, but was really beside the point…

This was not my only encounter with scientists who try to win the debate by making fun of a theory, a finding or …people. But it is not only the witty scientist who is to *blame*, it is also the uncritical audience that just swallows it.

I have similar feelings with some journal articles or blog posts that try to ridicule EBM – or any other theory or approach. Funny, perhaps, but often misunderstood and misused by “the audience”.

Jacqueline had this to say about the parachute article:

I found the article only mildly amusing. It is so unrealistic, that it becomes absurd. Not that I don’t enjoy absurdities at times, but absurdities should not assume a life of their own.  In this way it doesn’t evoke a true discussion, but only worsens the prejudice some people already have.

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A “Double Standard”?

Last week I had planned to write a comprehensive critique of a recent comment by Larry Dossey. He had posted it on Val Jones’s betterhealth website in response to Dr. Val’s essay, “The Decade’s Top 5 Threats To Science In Medicine,” originally posted here on SBM. Much of what Dr. Val had identified as the top threats involved recent dalliances, by government, medical schools, and the media, with the collection of implausible and mostly nonsensical health claims that advocates have dubbed “CAM.” As uncontroversial as Dr. Val’s assertions ought to have been—similar to suggesting that closing one’s eyes and “using the force” would be a threat to safe driving (even if some might quibble over the top threats to science in medicine)—Dr. Dossey demurred by distraction:

Your article implies that conventional medicine is grounded in evidence-based research and that CAM is not. This is grossly overstated, and suggests that a double standard is being applied to these fields.

Dossey trotted out familiar arguments: “Much, if not most, of contemporary medical practice still lacks a scientific foundation”; “the Congressional Office of Technology Assessment (OTA) found that only an estimated 10 to 20% of the techniques that physicians use are empirically proven”; hospital care is “the third leading cause of death in the United States,” accounting for hundreds of thousands of deaths each year.

He concluded with an appeal to fairness, rationality, and collegiality:

Overwhelming evidence reveals that conventional medicine is, on the whole, woefully unscientific. It’s fashionable and easy to deny this, but the facts say otherwise. So, by all means, Dr. Val, be critical of CAM – but do not fall into a double standard. Let us ruthlessly apply science to ALL we do as physicians. Let us challenge ALL areas of medicine to a higher standard. On that, I’m pretty sure we can agree.

Keep up the good work.

Sincerely yours,
Larry Dossey, MD

I procrastinated with my own rebuttal, and in the meantime David Gorski responded to similar language found in an article by Dossey (and two other magical thinkers) titled “The Mythology of Science-Based Medicine,” published by the Huffington Post. I’ll not repeat Dr. Gorski’s able rebuttal in any detail, and I’ve already written about much of what this matter brings to mind. Examples are here, here, and here on the perils of conflating science-based medicine and Evidence-Based Medicine (EBM); here on the false dichotomy of modern medicine vs. “CAM”; here on a concise definition of “CAM”; here and here on the mischief spawned by demands to “ruthlessly apply science,” in the narrow, EBM sense of the word, to implausible health claims; here (point #7) and here regarding the tu quoque fallacy, the “10-20% empirically proven” claim, and the risks of modern health care; here (scroll down to “this week’s entry”) and here, regarding some of Dossey’s own opinions about science and the future of medicine.

For now I’ll elaborate on a few points. These pertain not only to Dr. Dossey but also to myths common to the advocacy of pseudomedicine, so I hope to provide some useful information.

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The YOU Docs, for those of you (YOU?) who are unaware, are Doctors Mehmet Oz and Mike Roizen, authors of books about YOU and a weekly newspaper column called The YOU Docs. It’s all about YOU.

There are two areas of the knowledge where I have more than passing understanding: infectious diseases and sCAMs. It always concerns me when I read nonsense in the few areas where I have some expertise. I have to wonder about the validity of other information in the paper like war and the economy. You know, important stuff. It could probably be argued that since the YOU Docs are in the “How We Live” section, the same section that carries horoscopes, the movie and TV reviews, the weather report — the fiction section — it should not taken seriously. After all, it is usually adjacent to the People’s Pharmacist, and my father always told me that you can judge a person by the company they keep.

The YOU Docs had a column with the headline: “Research backs acupuncture for a range of ills“. More fiction? Research backs acupuncture? News to me, but they are, after all, YOU Docs, and therefore may have information not accessible to mere docs with a small ‘d’. I grant up front to the authors that it is hard to be rigorous, or even coherent, in a 452 word essay. I am over 3,200 words for this entry. There are also no references, so I have to assume I found the correct research mentioned by the hints in the text.

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If there’s one thing about the so-called “complementary and alternative medicine” (CAM) movement that I’ve emphasized time and time again, it’s that its adherents have a definite love-hate relationship with science. They hate it because it is the single greatest threat to their beliefs system and the pseudoscience that underlies it. At the same time, they crave the legitimacy that science confers. They crave it not because they have any great love for science. Quite the contrary. It is simply that they recognize that science actually delivers the goods. Of course, they believe that they deliver the goods too, but they come to this belief not through science but rather through all the cognitive shortcomings and biases to which humans are prone, such as confusing correlation with causation, confirmation bias, not recognizing regression to the mean, and being fooled by the placebo effect. Whether it’s through a misunderstanding of science or less innocent reasons, they go to great lengths to torture it into superficially appearing to support their claims through a combination of cherry-picking of studies that seem to support them and misrepresenting ones that don’t, discussions of which abound right here in this very blog.

The other thing I’ve emphasized about the CAM movement is that, even more than scientific credibility, they crave legitimacy. To them, however, science is but one pathway to legitimacy, because, unlike practitioners of science-based medicine, they are more than willing to bypass science to obtain the legitimacy–or at least the appearance of the legitimacy–they so crave. If it means doing an end run around science by trying to hijack the Obama health insurance reform bill that is currently being negotiated to resolve the differences between the Senate and House versions, so be it. Indeed, earlier this year, I described how Senator Tom Harkin has tried to promote CAM through the National Center for Complementary and Alternative Medicine (NCCAM) and trying to insert provisions into the bill that would mandate that government-subsidized insurance exchanges pay for CAM. Meanwhile, prominent CAM advocates have been carpet-bombing the media with dubious arguments in support of CAM, as in when Deepak Chopra, Rustum Roy, Dean Ornish, and Andrew Weil teamed up in different combinations to promote the idea that CAM is all about “prevention” and that science-based medicine, in all its reductionistic evil, is nothing more than pushing pills.

They’re at it again.
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Another one bites the dust.

The National Center for Complementary and Alternative Medicine (NCCAM) is generally a waste of taxpayer money, but they have sponsored several well-designed large trials of popular herbal supplements. And one by one these studies have shown these popular products, such as echinacea for the common cold, to be ineffective.

To add to the list, published in JAMA this week are the results of the largest and longest trial to date of Gingko biloba for the improvement of cognitive function and to treat, prevent, or reduce the effects of Alzheimers disease or other dementia. The results of the study are completely negative.

The study was very rigorous – a consensus trial designed to address all the criticisms of prior smaller studies. It was a direct comparison of Gingko biloba at 120mg twice a day, double blind, randomized, multi-center trial involving 3019 subjects aged 72-96 for a median of 6.1 years. Subjects were followed with standardized tests of cognitive function.

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As 2009 comes to an end, it seems that everyone is creating year-in-review lists. I thought I’d jump on the list band wagon and offer my purely subjective top 5 threats to rational thought in healthcare and medicine.

Of course, it strikes me as rather ironic that we’re having this discussion – who knew that medicine could be divorced from science in the first place? I thought the two went hand-in-hand, like a nice antigen and its receptor… and yet, here we are, on the verge of tremendous technological breakthroughs (thanks to advances in our understanding of molecular genetics, immunology, and biochemistry, etc.), faced with a growing number of people who prefer to resort to placebo-based remedies (such as heavy-metal laced herbs or vigorously shaken water) and Christian Science Prayer.

And so, without further ado, here’s my list of the top 5 threats to science in medicine for 2009 and beyond:
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While doctor visits for influenza-like illnesses seem to be trending downward again, and ”swine flu” is becoming old news, I’d like to draw attention to an H1N1 story that has received very little coverage by the mainstream media.

Doctors in several states can now protect their most vulnerable patients from the H1N1 virus without worrying about breaking the law. In order to save lives, several states have announced emergency waivers of their own inane public health laws, which ban the use of thimerosal-containing vaccines for pregnant women and young children.

Legislators in California, New York, Illinois, Missouri, Iowa, Delaware, and Washington state have enacted these science-ignoring laws in response to pressures from the anti-vaccine lobby and fear-struck constituents. Except for minor differences, each state’s law is essentially the same, so I will focus on the one from my state of New York.

New York State Public Health Law §2112 became effective on July 1, 2008. It prohibits the administration of vaccines containing more than trace amounts of thimerosal to woman who know they are pregnant, and to children under the age of 3. The term “trace amounts” is defined by this law as 0.625 micrograms of mercury per 0.25 mL dose of influenza vaccine for children under 3, or 0.5 micrograms per 0.5 mL dose of all other vaccines for children under 3 and pregnant women. Because thimerosal (and thus, mercury) exists only in multi-dose vials of the influenza vaccines (both seasonal and novel H1N1), this law really only applies to these vaccines. The mercury concentration of the influenza vaccines is 25 micrograms per 0.5 mL, which therefore makes their use illegal. Unfortunately, the only form of the H1N1 vaccine initially distributed, and that could be used for young children and pregnant women, was the thimerosal-containing form. The thimerosal-free vaccine was the last to ship, and in low supply, and the nasal spray is a live-virus vaccine, not approved for use in pregnancy or children under 2. That meant, without a waiver of the thimerosal ban, these groups could not be vaccinated.
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Time and time again, we’ve seen it. When pseudoscientists and quacks can’t persuade the scientific and medical community of the validity of their claims, they go to the law to try to gain the legitimacy that their claims can’t garner through proving themselves by the scientific method. True, purveyors of pseudoscience and unscientifically-derived medical practices do crave the respectability of science. That’s why they try so hard to take on the trappings of science. The problem is that they just can’t do it right, try as they might, or when they do it right their methods are shown to be no more effective than a placebo, aside from the occasional seeming “positive” results that would be expected based on random chance alone. However, failing to achieve the respectability that the mantle of science provides, practitioners and advocates of pseudoscience frequently try to codify their woo into the law.

The reason that they would do this is not too hard to discern. Few legislators and politicians are scientists, and even fewer are scientifically inclined. Back when I still lived in New Jersey, I may have been lucky enough to have had a Congressional Representative who really was a rocket scientist (well, a physicist, actually), but now that I live in Michigan I’ve gone from having a scientifically inclined Congressional representative to having one of the dimmest bulbs in Congress representing me. What that means is that it’s far easier to persuade politicians that this woo or that woo deserves to be permitted or even licensed. That’s how we now have many states licensing acupuncturists, naturopaths, and even “homeopathic physicians,” as Arizona does. The pressure for this sort of acceptance of unscientific medical modalities is building, as well, as Kimball Atwood has documented. Another example is the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 and in essence ties the FDA’s hands when it comes to regulating most supplements. Indeed, the very existence of the National Center for Complementary and Alternative Medicine (NCCAM) is a testament to the success of this approach, as a powerful Senator (Tom Harkin, D-IA) almost single-handedly foisted this scientific atrocity on the NIH against the desires of scientists. The results have included a $30 million scientific boondoggle of a trial to test chelation therapy and a profoundly unethical trial of Dr. Nicholas Gonzalez’s “protocol” for pancreatic cancer patients that a recent clinical trial has shown to be worse than useless. The most recent example of this trend is the way that CAM supporters have tried to hijack President Obama’s health insurance reform initiative to insert coverage for everything from any licensed “alternative medicine” practitioner to Christian Science prayer healing.

Recently, two new fronts have been opened up in this battle. One is disturbingly close to me, as it involves the Canadian province of Ontario whose north shore on the Detroit River is less than two and a half miles from my office, the other in Oregon, which, although it’s happening nearly 2,000 miles away from where I live and practice, could portend a new and disturbing tactic of the anti-vaccine movement to do what various other purveyors of pseudoscience have done before and try to win in state legislatures where they can’t win in science or the courts. Of course, in a democratic republic, it is the right of everyone, even supporters of quackery, to try to petition his or her legislators, but it is equally the responsibility of those of us supporting science-based medicine to try to educate legislators why allowing them to alter the law to protect their pseudoscience has the potential to result in great harm.
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The National Center for Complementary and Alternative Medicine (NCCAM) has posted three essays about its latest “strategic planning process,” and has invited “stakeholders” to make comments. I have previously made my own opinions clear,* as have fellow bloggers Gorski, Novella, Lipson, and Sampson: the best strategic plan for the NCCAM would be to extinguish itself. Since politics makes that plan unlikely, there are strategies that could minimize the considerable harm now done by the Center, while possibly offering a modest benefit. In summary:

• For both scientific and ethical reasons the NCCAM must dispense with trials of highly implausible claims. It should start by abandoning the ongoing Trial to Assess Chelation Therapy (TACT), its largest and most expensive trial yet, and one that has proven to place experimental subjects in considerable danger. It should publicly acknowledge such mistakes and explain why they must not be repeated—no matter how much political pressure there may be to do so.
• The Center should use its website’s Health Information function to explain what’s known, rather than continue its customary practice of putting the best possible slant on most “CAM” claims, no matter how absurd or disproven.
• The Center should address aspects of “CAM” advocacy that it has previously avoided, the most important being the close affiliation of such advocacy with the anti-vaccination (and autism quackery) movement. The NCCAM should consider itself an important source of rational information for a public that is currently, and dangerously, misled about immunizations. A related example of mischievous “CAM” advocacy, so far also ignored by the Center’s website, involves an imagined, sinister cartel of physicians, the AMA, pharmaceutical companies, and the FDA. The NCCAM should vigorously debunk such myths by providing facts and data.
• The Center should pursue the question of why some people are stubbornly attracted to implausible, unproven, and/or inert treatments. Wally Sampson suggested this idea years ago. It is one of many legacies of the late Barry Beyerstein, among others, whose writings could serve as a template for legitimate NCCAM research topics.

The NCCAM’s Charter and its boosters in Congress make such strategies exceedingly unlikely, as explained here. Therefore, in this and two subsequent postings I’ll address a few of the assertions made in each of the Center’s three “big picture” essays. These will not be comprehensive critiques of those essays, which would require deconstructions of nearly every sentence.

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