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No, sugar pills won’t repel insects, and other consequences of regulating nonsense

As a group blog, Science-Based Medicine brings a variety of perspectives to issues of science in medicine. However we align around a few core principles which define what science-based medicine is, and how it should be practiced. One principle we emphasize is the importance of subjecting the evaluation of all health interventions and treatments to a single, science-based standard. One of the biggest successes of the alternative medicine industry, worldwide, has been the embedding of different regulatory standards for the evaluation and approval of so-called “non-drug” products such as supplements, herbal products, and non-scientific treatment systems like homeopathy or traditional Chinese medicine (TCM). The implications cannot be overstated: this different and lower standard is now so firmly entrenched in most health systems that few seem to question its rationale, or consider the consequences. As a practicing pharmacist I spent the first decade of my career working within this regulatory framework without ever stepping back to question why we regulate some products differently. I started reading, took the red pill, and here I am today. (more…)

Posted in: Homeopathy, Science and Medicine

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Bee Venom Therapy Update

I wrote previously about bee venom therapy (BVT), also called apitherapy or bee sting therapy, as an emerging “alternative” therapy. Both use and research into BVT continue, providing an excellent example of the many things that are wrong with the CAM movement.

A recent Reuters article on the topic is also an excellent example of the frequent complete failure of the mainstream media in dealing with such topics. The articles discusses a Filipino bee keeper who decided to practice medicine based upon his personal anecdotal experience. Joel Magsaysay suffered a stroke and right-sided weakness. He attributes his recovery from the stroke partly to bee stings.

He admits he is not a physician and has no medical or scientific background. He has concluded that BVT works based upon anecdote along. He seems to be unaware of the unreliability of individual anecdotes in stroke recovery. Most patients will improve following a stroke. There are also two kinds of recovery, including neurological recovery from brain plasticity.

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Posted in: Science and Medicine

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Followup: Benedetti on Placebo Ethics

A few months ago I wrote about Fabrizio Benedetti’s research on the neurobiology of the placebo response, and a discussion about placebos and ethics ensued in the comments. Now Dr. Benedetti has written about that issue in a “Perspective” article in the journal World Psychiatry, “The placebo response: science versus ethics and the vulnerability of the patient.” 

We have learned that verbal suggestions can activate neurotransmitters and modulate pain perceptions, and positive expectations can activate endogenous opioid and cannabinoid systems. A complex mental activity has objective effects on body physiology. Words and drugs can activate the same mechanisms. Drugs are less effective without therapeutic rituals. We are delving deep into human foibles and vulnerable traits at the center of human interactions. What implications do these insights into mind-body interactions have for patient care?

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Posted in: Medical Ethics

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Cantron: A tale of false hope for cancer

A couple of months ago, a reader sent me an article that really disturbed me. In fact, I had originally been planning to write about it not long after I received it. It is, as you might imagine given my specialty and what disturbs me the most wehen I encounter quackery, a story of a cancer patient. Worse, it’s the story of a cancer patient in my neck of the woods. True, it’s not in the same country, but my cancer center is only around two or three miles from the Detroit River and the Canadian border; so it’s plenty close enough. Too close, in fact. Reading the story, in fact, I realized that it features a form of cancer quackery that, as far as my searches have been able to tell me, we haven’t covered before here at SBM, which alone makes it worth taking on, even though the story is two months old. The “cure” is called Cantron, and it is deeply rooted right here in my metropolitan area. Not only that, its siren song and false promises are attracting patients from across the boarder in Canada. Bernie Mulligan is one such patient:
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Posted in: Cancer, Health Fraud, Homeopathy, Science and the Media

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Science, Evidence and Guidelines

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: (more…)

Posted in: Epidemiology, Medical Academia, Pharmaceuticals, Science and Medicine

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Legislative Alchemy: 2012.5

legislative-alchemy-imageLegislative 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 naturopathychiropractic 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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Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation

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Liberation Procedure for Multiple Sclerosis

Balloon dilatation of a stenosed jugular vein, the "liberation procedure" promoted as treating multiple sclerosis.

Balloon dilatation of a stenosed jugular vein, the “liberation procedure” promoted as treating multiple sclerosis.

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. (more…)

Posted in: Neuroscience/Mental Health

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What Would It Take?

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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Posted in: Energy Medicine

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Quackademic medicine trickles out to community hospitals

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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Posted in: Acupuncture, Herbs & Supplements, Medical Academia, Medical Ethics, Science and the Media

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Foolishness or Fraud? Bogus Science at NCCAM

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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Posted in: Acupuncture, Basic Science, Health Fraud, Politics and Regulation, Public Health, Science and Medicine

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