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Report from the SBM Conference

On July 9th we held our first Science Based Medicine conference in Las Vegas. The event was definitely a success – we filled our room to capacity (150 attendees) and almost everyone stayed until the end. It also appeared that most attendees were actually awake, a rarity for a full-day medical conference. The Q&A session at the end was lively and interesting.

Kimball Atwood and I covered the history of science-based medicine and explored the differences between EBM and SBM. David Gorski discussed cancer quackery, including specific cases to illustrate the potential harm of pursuing worthless therapies for serious diseases. Harriet Hall gave us an overview of the the pseudoscience endemic in chiropractic. Mark Crislip discussed the chronic Lyme disease controversy. And Val Jones discussed health information online.

Based upon the feedback from those attending the conference, as well as the general enthusiasm, it seems that there is a hunger for this type of information. The audience was split about even between health care professionals and interested lay public. Many people asked if we plan on giving the conference again, and the answer is definitely yes. We have no plans set as of yet, and will certainly announce any future conferences here.

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Posted in: General

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Homeocracy IV

In the three prior posts of this series I tried to analyze some of the defects in the randomized clinical rials (RCTs) of homeopathic remedies for childhood diarrhea. The first entry showed that the first two RCTs’ (done in Nicaragua) methods could not produce a meaningful result because of the way the RCTs were set up (methods.) The second entry showed that the results obtained in the first two trials were meaningless clinically even if assumed to have resulted from more legitimate methods. The same applied to the third trial in Nepal, analyzed in the third entry.

This entry  will suggest that the authors’ fourth paper (Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials.  Pediat Inf Dis J, 2005;22:229-234.)- a meta-analysis (MA) of the data from the three RCTs resulted in conclusions equally as meaningless as those of the three trials.

The MA authors – several of the same workers from the three RCTs – begin by agreeing that the data from the RCTs, taken individually, were of borderline significance:

In our previous three studies, we evaluated the use of individualized homeopathic treatment of childhood diarrhea … The results of the two larger studies (n = 81, n = 116) were just at or near level of statistical significance. Because all three studies followed the same basic study design , […] we analyzed the combined data from these three studies to obtain greater statistical power.  In addition we conducted a meta-analysis of effect-size difference […] to look for consistency of effects.

MAs and systematic reviews (SRs) are the two consensus methods for summarizing data from multiple individual studies. The inclusion and search methods of RCTs for SRs and MAs are similar, but the objectives of the two are a bit different, as are the forms of the reports.  In SRs, the results are summarized  in more in narrative form, whereas in MAs the data are treated mathematically and the results are defined in statistical terms.  Thus authors of SRs are freer to speculate on the degree of confidence that a method is effective based on what is shown by the numbers of positive and negative RCTs collected.  Authors of MAs usually limit their comments to what the mathematical formulation of the summarized data show.
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Posted in: Clinical Trials, Energy Medicine, General, Homeopathy, Science and Medicine

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Science And The Game Of 20 Questions

An audience member at a recent NYC Skeptics meeting asked me how I handled conflict surrounding strongly held beliefs that are not supported by conclusive evidence. As a dentist, he argued, he often witnessed professionals touting procedure A over procedure B as the “best way” to do X, when in reality there are no controlled clinical trials comparing A and B. “How am I to know what’s right in these circumstances?” He asked.

And this is more-or-less what I said:

The truth is, you probably can’t know which procedure is better. At least, not at this point in history. The beauty of science is that it’s evolving. We are constantly learning more about our bodies and our environment, so that we are getting an ever-clearer degree of resolution on what we see and experience.

It’s like having a blurry camera lens at a farm.  At first we can only perceive that there are living things moving around on the other side of the lens – but as we begin to focus the camera, we begin to make out that the animals are in the horse or cattle family. With further focus we might be able to differentiate a horse from a cow… and eventually we’ll be able to tell if the horse has a saddle on it, and maybe one day we’ll be able to see what brand of saddle it is. Each scientific conundrum that we approach is often quite blurry at the onset. People get very invested in their theories of the presence or absence of cows, and whether or not the moving objects could in fact be horses. Others say that those looking through the camera contradict one another too much to be trusted – that they must be offering false ideas or willfully misleading people about the picture they’re describing.

In fact, we just have different degrees of clarity on issues at any given point in time. This is not cause for alarm, nor is it a reason to abandon our cameras. No, it just gives us more reason to continue to review, analyze, and revise our understanding of the picture at hand. We should try not to make more out of photo than we can at a given resolution – and understand that contradicting opinions are more likely to be evidence of insufficient information than a fundamental flaw of the scientific method.
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Posted in: General, Science and Medicine

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Being Right Versus Being Influential

On May 9th I had the pleasure of lecturing to an audience of critical thinkers at the NYC Skeptics meeting. The topic of discussion was pseudoscience on the Internet – and I spent about 50 minutes talking about all the misleading health information and websites available to (and frequented by) patients. The common denominator for most of these well-intentioned but misguided efforts is a fundamental lack of understanding of the scientific method, and the myriad ways that humans can fool ourselves into perceiving a cause and effect relationship between unrelated phenomena.

But most importantly, we had the chance to touch upon a theme that has been troubling me greatly over the past couple of years: the rise in influence of those untrained in science on matters of medicine. I have been astonished by the ability of “thought leaders” like Jenny McCarthy to gain a broad platform of influence (i.e. Oprah Winfrey’s TV network) despite her obviously flawed beliefs about the pathophysiology of autism. Why is it so hard to find a medical voice of reason in mainstream media?

The answer is probably related to two issues: first, good science makes bad television, and second, physicians are going about PR and communications in the wrong way. We are taught to put emotions aside as we carefully weigh evidence to get to the bottom of things. But we are not taught to reinfuse the subject with emotion once we’ve come to an impartial consensus. Instead, we tend to bicker about statistical analyses, and alienate John Q. Public with what appears to him as academic minutiae and hair-splitting.

I’m not sure what we can or should offer in place of our “business as usual” behavior – but I’ve noticed that being right isn’t the same as being influential. I wonder how we can better advance the cause of science (for the sake of public health at a minimum) to an audience drawn more to passion than to substance?

I would really enjoy your input, dear readers of Science Based Medicine, because I’m at a loss as to what we should do next to reach people in our current culture, and with new communications platforms. What would you recommend?

Posted in: General, Public Health, Science and Medicine, Science and the Media

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Double-Talk And Paternalism

One of the more frustrating things about practitioners who promote unsafe and scientifically discredited medical practices is their tendency to change their message for different audiences. One day they’ll tell you that they espouse only evidence-based practices and the next they’ll be promoting snake oil. This double talk is hard to combat, since to disprove them one would essentially have to provide a video of their contradictory remarks.

One day I participated in a series of business meetings with a CAM practitioner in attendance (he was an MD who graduated from UCSF). During one meeting he boldly proclaimed his support of scientifically rigorous research, and praised the Cochrane Collaborative’s efforts to provide systematic reviews of the evidence (or lack thereof) for various practices.

Several hours later we were sitting together in another meeting in which I objected to the publication of a consumer article that would assist parents of children with autism in finding a DAN! practitioner who could provide chelation therapy to their children. I explained that there was no evidence for the efficacy of such treatments, and plenty of evidence for their harm (including the death of at least one child that I’d read about in the news). I suggested that an article describing these dangers might be in order, but that an article encouraging chelation use for autism was simply unethical and I would not allow it to be published.

Instead of agreeing with me, the CAM MD suggested that I was being “narrow” and that I should allow consumers to “explore all their options.” I was stunned. This was the same person who had just said that he fully supported scientific inquiry. So I asked him how he could say that he supported evidence-based medicine, and then turn around and ignore evidence at will – even at the peril of human life.

His response dumbfounded me:

“I am just as comfortable practicing within an evidence-based framework as I am outside it.”
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Posted in: General, Public Health, Science and Medicine

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Medical Propaganda Films

David Gorski suggested I expand on a comment I left recently on one of his November posts. His subject was the then new documentary movie, “A Beautiful Truth.“ “Truth” is about the Gerson method – the dietary deprivation cum coffee enema cancer treatment developed by Dr. Max Gerson, a refugeee from Germany I the 1930s. His daughter, Charlotte now runs the Gerson Institute in Tijuana, Mexico. Gerson is one of the models for the Gonzales method recently reviewed by Kim Atwood.

I had previously referred to the movie in a prior post (1) (but in a different context. Here I’ll explore the movie from a different angle – with its partners, propaganda documentaries.

David called my attention to “Truth” plus another by the same producer – with trailers on You Tube. When I watched the trailers last year I saw myself interviewed briefly, but could not recall being filmed, or even identify where the scene took place. I had to email Steve Barrett, also in the movie, who reminded me about filmmaker Steve Kroschel’s visits 2-3 years before, although neither did he have strong memory of the interview.
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Posted in: Cancer, Clinical Trials, Energy Medicine, General, Health Fraud, Herbs & Supplements, Nutrition, Science and Medicine, Science and the Media

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When Should We Call A Quack A Quack?

It is not uncommon for Science Based Medicine to receive complaints about the tone of our writing. Some people feel that it is indelicate to use the “q” word (for the uninitiated, “q” is for “quack”) when describing practitioners who promote disproven therapies with jubilant fervor. Others believe it unkind to lump “well meaning” alternative medicine experts in with those who are engaged in overtly illegal activities.

We are all affected by the tension between wanting to call a spade a spade and respecting our cultural need to be polite. Perhaps one of the clearest examples of this inner conflict is Orac’s Respectful Insolence blog. As the name implies, Orac is both thoughtful and brutally honest – he expresses our communal reticence to make waves, but follows up with a reasoned hostility that is quite understandable, given the circumstances described in each post. Respectful Insolence is fun to read because it is educational, persuasive, and expressive – and it captures how many of us feel about various forms of hucksterism. However, snake oil salesmen and their sympathizers are unlikely to enjoy the blog.

Here at Science Based Medicine, readers find a wide range of expression with a common commitment to science and reason. Just as physicians have different practice styles (some are more nurturing in temperament, others offer “tough love”) so too do we authors vary in tone. For those readers who favor one style over another – I hope you’ll find the voice that suits you and return regularly for more. Please don’t assume that one particular post is representative of the entire blog, and please don’t be offended by the legitimate exasperation of writers who have suffered through decades of observing swindlers swindle.
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Posted in: Cancer, General, Science and Medicine

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Placebo Therapies: Are They Ethical?

Is it ethical to overstate the efficacy of a treatment option, if it might lead to a patient’s enhanced experience of that treatment? Your response to this question may reveal the degree to which you favor Complementary and Alternative Medicine (CAM). Let me explain.

As far as I can tell, no CAM treatment has been proven effective beyond placebo. (If you’re not convinced of this, I suggest you take a look at Barker Bausell’s book on the subject.) That means that treatments like acupuncture, homeopathy, Reiki, energy healing, Traditional Chinese Medicine (such as cupping), and others (like “liver flushes”) perform about as well as placebos (inert alternatives) in head-to-head studies. Therefore, the effects of these treatments cannot be explained by inherent mechanisms of action, but rather the mind’s perception of their value. In essence, the majority of CAM treatments are likely to be placebo therapies, with different levels of associated ritual.

For the sake of argument, let’s assume that CAM therapies are in fact placebos – the question then becomes, is it ethical to prescribe placebos to patients?  It seems that many U.S. physicians believe that it is not appropriate to overstate potential therapeutic benefits to patients. In fact, the AMA strictly prohibits such a practice:

“Physicians may use [a] placebo for diagnosis or treatment only if the patient is informed of and agrees to its use.”

Moreover, a recent article in the New England Journal of Medicine concludes:

“Outside the setting of clinical trials, there is no justification for the use of placebos.”

However, there is some wavering on the absolute contraindication of placebos. A recent survey conducted by researchers at the Mayo Clinic asked physicians if it was permissible to give a dextrose tablet to a non-diabetic patient with fibromyalgia if that tablet was shown to be superior to no treatment in a clinical trial. In this case 62% of respondents said that it would be acceptable to give the pill.

The authors note:

“Before 1960, administration of inert substances to promote placebo effects or to satisfy patients’ expectations of receiving a prescribed treatment was commonplace in medical practice. With the development of effective pharmaceutical interventions and the increased emphasis on informed consent, the use of placebo treatments in clinical care has been widely criticized. Prescribing a placebo, it is claimed, involves deception and therefore violates patients’ autonomy and informed consent. Advocates of placebo treatments argue that promoting the placebo effect might be one of the most effective treatments available for many chronic conditions and can be accomplished without deception.”

How do you feel about placebos? Are they a legitimate option in some cases, or a violation of patient autonomy and informed consent?
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Posted in: General, Medical Ethics, Science and Medicine

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How To Get Physicians To Use The Same Science-Based Playbook

Pretty much everyone agrees that we need to improve the quality of healthcare delivered to patients in the US. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.

However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.

There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.

I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.

Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.
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Posted in: General, Politics and Regulation, Public Health, Science and Medicine

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Fakin’ it

Last week the Times of London revealed inside information from the General Medical Council (UK, responsible for physician licensing) of an ongoing investigation of Dr. Andrew Wakefield and from its own investigation. This revelation recalled other instances of fakery from reports of sectarian medicine (“CAM”) successes. The Medical Council information contained evidence that the data from the now famous Wakefield cases used to claim an association of the MMR vaccine with childhood autism and inflammatory bowel disease were misinterpreted, altered, and to some extent, faked. The report and history were reviewed by David Gorski last week. In eight of twelve cases, the dates of autism onset were “rearranged” to fit the needed time association, and many small bowel biopsies were “reinterpreted” to show inflammation.

The Wakefield claims were long suspected by reputable medical scientists and skeptics  as being erroneous or fraudulent.  Note: the Council hearings are still in progress, and the Times report is subject to legal complaint.  The original details can also be seen in the Times articles.

This expose’ adds to a growing list of reports with erroneous and faked information in medical journals used either for economic reward, undeserved fame, or to promote ideological claims for medical sects and cults. Although history of erroneous or false claims goes back hundreds of years, the altering or synthesizing of data passing the recently conceived peer review system is new,  illuminating defects in the journal peer review and editing system.

If journals were invented in the 18th century, and operated like journals of today, Mesmer’s demonstrations might have been published, and the Ben Franklin and Antoine Lavoisier and French Academy’s disproof might have been rejected. (Laughter here.) But journals continue to make major goofs in publishing implausible results despite the popularity of a famous specialty journal for that purpose.

Examples vary from acceptance of language manipulation – “alternative,” “healing,” “integrative,” etc., to the fakery of recent papers showing effects of prayer. The two famous studies of prayer in the cardiac care unit ranged from the unadmitted breaking of the blind in the Bird study (So Med J 1988; 81:826-826) to unadmitted imbalances of subject and control groups (Harris, Arch Int Med 1999;159:2273-2278.) And from those to the likely fakery of the distant prayer study of in vitro fertilization (Cha, Wirth, Lobo; J Reprod Med 2001:46;781-786) in which three separate prayer groups on two continents improved pregnancy rates in a group of women on a third continent by an implausible 100 percent. In all of these cases, the papers passed peer or editorial review despite the methodological defects that were picked up by us skeptics (K. Atwood, K.Courcey [an RN] B. Flamm, and others.)

Adding insult to the above, Annals of Internal Medicine published a systematic review of intercessory prayer (Astin et al, Ann Int Med, 2000;132: 903-910) containing not only the Bird and Harris studies counted as positive, but also the Targ study on brain tumors, found by reporter Po Bronson to have had its end point altered by the authors when the primary one showed no effect.
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Posted in: Basic Science, Clinical Trials, Faith Healing & Spirituality, General, Health Fraud, Medical Academia, Science and Medicine, Vaccines

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