Science-Based Medicine

Disclaimer:  I am a paid Medscape  blogger and writer, and since they are in part supported by advertisements from the Pharmaceutical companies,  indirectly I am in the thrall of Big Pharma.

I found Harriet’s post on the Medscape Connect topic of How do you feel about Evidence-Based Medicine? interesting.

I wondered about the breakdown of the comments by both specialty and opinions about SBM.  So I read the 226  comments and classified them by field and response.  I classified each response as disapprove, approve or nuanced.  It is not, obviously, a legitimate survey and there was more than a little subjective interpretation in deciding how to classify the responses.  I have no doubt that others would get different results; it is not methodologically sound analysis. The discussion was in the Family Medicine & Primary Care section, so it is unlikely to be representative of any population, including that of Family Practitioners and Primary Care Physicians.  I would bet, as in alternative medicine and most topics, Shruggies predominate and are the silent majority.

Even though I belong to what  a commentator referred to as the not so silent “militant wing” of SBM, I was surprised at my results: Continue Reading »

Legislative alchemy, as faithful SBM readers know, is the process by which state legislatures and Congress take scientifically implausible and unproven treatments and diagnostic methods and turn them into licensed health care practices and legally sold products. Previous posts have explored this phenomenon in naturopathy, chiropractic and acupuncture.

Our last report on the legislative efforts of CAM providers appeared almost six months ago, the beginning of the legislative year for many states. Now, most legislatures have shuttered the statehouse doors and gone home. So let’s see how the CAM practitioners are doing this year.

Naturopathy

A goal of the American Association of Naturopathic Physicians (AANP) is “full scope of practice” in all 50 U.S. states. They’ve got a ways to go. Naturopaths are currently licensed to practice in only 17 states and the District of Columbia. Bills to expand licensure failed to make it out of committee again during the 2012 legislative sessions of two states, Iowa and Maryland. In Colorado and Virginia, where licensing bills failed to pass in previous years, no new legislation was introduced to license naturopaths in 2012. Bills to license naturopaths are still pending before legislative committees in Illinois, Massachusetts, Michigan, North Carolina, New York and Pennsylvania. However, in North Carolina and Pennsylvania these bills have been languishing in committee since 2011, making passage appear less likely This is especially true in North Carolina, where the legislative session ends soon.

Another strategy of the AANP is “progressive legislation.” This means that while some compromise in initial licensing legislation may be necessary to get a licensing bill passed, successive attempts can cure any initial disappointments through expansion of scope of practice and insurance coverage, for example. Nowhere was this strategy more successful in 2012 than in Vermont, where “naturopathic physicians” (as the Vermont Legislature calls them) were officially defined as “primary care providers” (PCPs) for the purpose of health insurance coverage. The new law means that naturopathic physician practices can qualify as patient “medical homes” under the state’s Blueprint for Health and that they may practice as such independently and without supervision.

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It has been very instructive, from a science-based medicine perspective, to watch the story of alleged chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS) unfold over the last three years. In 2009 Dr. Paolo Zamboni, an Italian vascular surgeon, published a paper in which he claimed that 100% of MS patients he investigated showed signs of blockage in the veins that drain blood from the brain, a condition he named CCSVI. This paper sparked immediate controversy. This controversy has been in the news again recently with the making public of the results of an observational study of the liberation procedure to treat CCSVI.

Existing research over the last half century strongly indicate that MS is primarily a disease of immune dysfunction (an autoimmune disease), resulting in inflammation in the brain that causes damage, specifically to the myelin, the insulation around  nerve fibers that allows them to conduct signals efficiently.  Zamboni is suggesting that MS is primarily a vascular disease causing back pressure on the veins in the brain and iron deposition which secondarily results in inflammation. This would be a significant paradigm shift in MS. It would also not be the first time such a dramatic shift in MS science has been proposed but failed in replication.

The MS community did not give much credence to the notion of CCSVI, but despite this there has been an incredible amount of research on the idea over the last three years (a PubMed search on “CCSVI” gives 103 results). Most of the research has simply attempted to replicate Zamboni’s findings, with mixed but generally unimpressive results. No one has found the 100% results that Zamboni originally reported. The studies have found a range of venous insufficiency in MS patients, down to 0%, but many finding results in the range of 20-40%. However, patients with other neurological disease and healthy controls have also been found to have similar rates of venous insufficiency. Some studies have found a positive correlation with MS, others have not.

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I recently wrote a SkepDoc column on fantasy physics in Skeptic magazine in which I mentioned a study that had allegedly measured 2 milligauss emanations from a healer’s hands. A reader inquired about it and went on to ask “what criteria is [sic] necessary for gaining acceptance in the scientific community in regards to purported healing processes using energy fields generated in the human hand, specifically the palm area.”

What would it take to prove this implausible claim to the satisfaction of the scientific community? That is an excellent question with a complicated answer. It’s worth looking at because there is only one science and the same standards apply to how science evaluates any claim. I’ll take a stab at it, and perhaps our commenters can add words of wisdom.

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One of the major themes of this blog has been to combat what I, borrowing a term coined (as far as I can tell) by Dr. R. W. Donnell, like to refer to as “quackademic medicine.” Quackademic medicine is a lovely term designed to summarize everything that is wrong with the increasing embrace of so-called “complementary and alternative medicine” (CAM) or, as it’s increasingly called now, “integrative medicine” (IM) into academic medical centers. CAM/IM now a required part of the curriculum in many medical schools, and increasingly medical schools and academic medical centers seem to be setting up IM centers and divisions and departments. Fueled by government sources, such as the National Center for Complementary and Alternative Medicine (NCCAM) and private sources, such as the Bravewell Collaborative (which has been covered extensively recently not just by me but by Kimball Atwood, Steve Novella, and Mark Crislip), academic medical centers are increasingly “normalizing” what was once rightly considered quackery, hence the term “quackademic medicine.” The result over the last 20 years has been dramatic, so much so that even bastions of what were once completely hard-core in their insistence on basing medicine in science can embrace naturopathy, Rudolf Steiner’s anthroposophic medicine, reiki and other forms of “energy healing,” traditional Chinese medicine, and even homeopathy, all apparently in a quest to keep the customer satisfied.

Of course, in a way, academia is rather late to the party. CAM has been showing up in clinics, shops, and malls for quite a while now. For example, when I recently traveled to Scottsdale to attend the annual meeting of the American Society of Breast Surgeons, I happened to stop in a mall looking for a quick meal at a food court and saw this:

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Voodoo science is a sort of background noise, annoying but rarely rising to a level that seriously interferes with genuine scientific discourse… The more serious threat is to the public, which is not often in a position to judge which claims are real and which are voodoo. Those who are fortunate enough to have chosen science as a career have an obligation to inform the public about voodoo science.

– Robert L. Park, PhD, 2000¹

Imagine you are an ordinary person with limited knowledge of science and medicine, and you see this 2010 video on tai chi and qi gong by the National Center for Complementary and Alternative Medicine (NCCAM) — one of the agencies that make up the National Institutes of Health (NIH). I am certain that the solemn voice of the Director of NCCAM, Dr. Josephine Briggs, talking about “rigorous scientific research” and “accurate, authoritative information on complementary and alternative medicine,” will leave you with a strong sense of confidence in her message.

In addition, despite the fine-print and the disclaimer, the appearance of Dr. Briggs in the video could be broadly viewed as a sign of tacit endorsement. Often, the very fact that a treatment is associated with the government is already a de facto stamp of approval and a warranty of efficacy. For instance, the publication below by the California Department of Consumer Affairs states that the NIH formally “endorses” acupuncture, simply because in 1997, a panel of scientists assessed its use and effectiveness for a variety of conditions. Since 1997 the scientific review of acupuncture by NIH has become synonymous with its endorsement, despite the fact that as a federal research agency, the NIH does not endorse any product, service, or treatment.

In October 26, 2011, a few weeks after Steve Jobs’ death, Josephine Briggs decided to do something she has never done before: she put an explicit disclaimer on her blog:

When making treatment decisions, unproven “alternative medicine” approaches should not replace conventional medical care approaches known to be useful or helpful. Simply put, the evidence is not there (emphasis added).²

Three paragraphs down the page, she goes on — with a candor rarely seen from her — that given the recent news about Steve Jobs’ choices for cancer treatment, all health decisions “should be guided by the best available evidence.”
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Is the best medicine no medicine at all? Sometimes. My past posts have emphasized that the appropriateness of any drug depends on an evaluation of benefits and risks. There are no completely safe interventions, and no drug is free of any side effects. Our choice is ideally informed by high-quality data like randomized controlled trials, with lots of real-world experience so we understand a drug’s true toxicity. But when it comes down to a single patient, treatment decisions are personalized: we must consider individual patient characteristics to understand the expected benefits and potential harms. And in a world with perfect prescribing and drug use, harms wouldn’t be eliminated, but they would be minimized. Unfortunately, we’re not there yet. There is ample evidence to show that the way in which prescription drugs are currently used causes avoidable harms to patients.

The art and science of medicine is a series of interventions to improve health. In making these treatment decisions, we strive to minimize iatrogenic harm — that is, harms caused by the intervention itself. High up on the list of of avoidable harms are adverse events related to drug treatments. Audits of adverse events are astonishing and shameful. Studies suggest 28% of events are avoidable in the community setting, and 42% are avoidable in long-term care settings.  That’s a tremendous amount of possible harm resulting from treatments that were prescribed to help. And the group that is harmed the most? The elderly. Continue Reading »

“The forces of graft and unrighteousness are peculiar to no country or clime, and they have their champions in the high places and the low. Until the people themselves are better educated concerning the danger and iniquity of quackery, they must be protected from the forces that prey. The popular understanding of these matters is becoming better every day, and, aided by proper laws, the time will come, perhaps, when quackery will be unprofitable.”

The above quote is from a recently published JAMA (Journal of the American Medical Association) article. I should say that it is republished, because it first appeared on June 8, 1912. The brief article outlines the issues surrounding the regulation of medical practice so as to protect the public from “quackery.” It is interesting to see that the issues faced 100 years ago are virtually identical (in broad brush strokes) to those we face today. Despite the fact that so much has changed in medicine over the last century, in this regard very little has changed.

To put this article into historical context, it was published just two years after the Flexner Report, generally recognized as the turning point in American and Canadian medical education when it truly embraced scientific and evidence-based practices. Mainstream medicine in 1912 was barely making the transition from being based upon tradition and authority to having scientific backing and genuine standards. Life expectancy in the US had just passed 50, up from a low of around 40 thirty years earlier. Phrenology was still practiced by mainstream psychiatrists and neurologists – although it was on the way out (having recently been refuted by scientific studies) and was increasingly being pushed to the fringe. The last purely homeopathic medical school in the US would not close until 1920. Patent medicines were still the norm, and the 1906 Pure Food and Drugs Act had only recently been enacted to establish some standards of safety in the medicine marketplace (this would essentially transform into the FDA in 1930).

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The term “evidence-based medicine” first appeared in the medical literature in 1992. It quickly became popular and developed into a systematic enterprise. A book by Ulrich Tröhler To Improve the Evidence of Medicine: The 18^th century British origins of a critical approach argues that its roots go back to the 1700s in Scotland and England. An e-mail correspondent recommended it to me. Can’t remember who, but I would like to thank him.

Francis Bacon (1561-1626) differentiated between “ordinary experience” (chance observations) and more objective “ordered experience” (methodological observations). Both of these involved empirical knowledge.  It’s hard to get back into the mindset of his time, when most physicians rejected empiricism as the sphere of quacks and surgeons.  Tröhler helps us understand why they did:

…since antiquity, the mark of distinction of a learned man had been the certainty of his knowledge. A doctor knew — he did not need to test his kind of knowledge empirically because this would imply acknowledgement of uncertainty.

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Few awards in anything have the cachet and respect the Nobel Prizes in various disciplines possess. In my specialty, medicine, the Nobel Prize in Physiology or Medicine is quite properly viewed as the height of achievement. In terms of prestige, particularly in the world of science, the Nobel Prize is without peer. To win the Nobel Prize in Medicine or another scientific field, a scientist must have made a discovery considered fundamentally important to the point that it changes the way we think about one aspect of science or medicine. Winning the Nobel Prize in a scientific field instantly elevates a scientist from whatever he or she was before to the upper echelons of world science.

So how, one might ask, is it that seemingly so frequently Nobel Laureates embrace crankery or pseudoscience in their later years? They call it the Nobel Disease, and, indeed, it’s a term listed in the Skeptics’ Dictionary (where the term is attributed to me based on this post about Linus Pauling from four years ago, but I can’t claim credit for coining the term; it existed before I wrote that post) and Rational Wiki, complete with examples. What inspired me to take on this topic, dusting off some old knowledge and writings, is that we apparently have a new victim of the Nobel Disease. Well, perhaps “new” is not the right word, but he is the most recent example. I’m referring to Luc Montagnier, who with Françoise Barré-Sinoussi was awarded the Nobel Prize in Medicine for the discovery of HIV in 2008.

Unfortunately, it didn’t take Montagnier very long to devolve into crankery. Until 2009, to be precise. Since then, Montagnier has embraced concepts like DNA teleportation and ideas very much like homeopathy. And then, just last month, his journey to the dark side was complete. Yes, Luc Montagnier presented at the yearly quackfest I discussed last week, the one in which there was much enthusiasm among the attendees for a treatment that involves administering bleach enemas to autistic children. He presented at Autism One, a coup that caused much rejoicing in the antivaccine movement.

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