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The Need for Transparency

A recent editorial in PLOS Medicine discusses the need for transparency in the medical literature, specifically with regard to comparative effectiveness research (CER). The editorial makes many excellent points, but also puts into clear relief the double standard that is consciously being fabricated by proponents of non-science-based medicine.

I wrote previously about another editorial that took a very different approach. Speaking for The Kings Fund, Professor Dame Carol Black said.

“The challenge is to develop methods of research that allow us to assess the value of an approach that seeks to integrate the physical intervention, the personal context in which it is given, and non-specific effects that together comprise a particular therapy.”

The editorial essentially defended the use of CER and other forms of evidence to bolster the evidence base for so-called CAM (complementary and alternative medicine) in order to promote its use.

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Posted in: Science and Medicine

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IVF and CAM Use

Perhaps the biggest hurdle to broader acceptance of the need for a consistent scientific basis for medical interventions is the attitude that worthless treatments are harmless. I often have the experience, after reviewing the evidence showing lack of efficacy for a specific intervention, of getting the head-tilt and shrug along with some variation of the dismissive attitude,  “Well, if people feel better, then what’s the harm?” In my opinion, ethics and intellectual honesty indicate that we have to do better than that.

The “what’s the harm” refrain is so tired and overused that it prompted a website by that name, documenting direct harm caused by unscientific treatment modalities. This is a helpful reminder that any intervention that actually does something (has biological activity) must also contain some risks. But this site also has significant limitations. First, it is anecdotal. But also it emphasizes direct harm, while the indirect harm of unscientific methods (for example by delaying definitive treatment) likely vastly outweighs the direct harm. However, indirect harm is extremely difficult to quantify.

Studies looking at the net clinical effects of using or relying upon unscientific methods is therefore desirable. Recently Danish researchers have published one such study:  Use of complementary and alternative medicines associated with a 30% lower ongoing pregnancy/live birth rate during 12 months of fertility treatment.

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Posted in: Science and Medicine

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Functional Medicine III

Let’s look at one example.

A unknown number of Functional Medicine adherents broadcast call-in programs on radio stations. One FM physician, a Dr. “D” in Northern California graduated from UC Davis School of Medicine (Central California’s Sacramento Valley.) I find her program fascinating, requiring some attentive listening.

Dr. D’s recommendations for people’s complaints and conditions are often complex, a chimera of standard explanations and therapies, but painted with a variety of views that are anything but standard. The problem I found was that some of each answer was rational – especially the logic of her differential diagnosis – but suddenly spun out into space with unfamiliar methods or some recognizable as one component or another of sectarianism. Some answers had no relationship to the problem at hand, but seemed to be plucked out of a firmament of independent ideas, theories, ideologies, and personal anecdotes – a medical Separate Reality.

One can be carried along by an answer that sounds on surface reasonable because of the confidence and the delivery’s vocal tone. Her voice is medium-low, sort of a mezzo or contralto. It’s a voice ideal for advice; confidence oozes. Some of her separate reality recommendations she precedes with a biochemical or physiological explanation, so the shifting from standard to “separate reality” grids goes so smoothly, the usual recognizable red flags may not spring up.

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Posted in: Science and Medicine

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Incorporating Placebos into Mainstream Medicine

Alternative medicine by definition is medicine that has not been shown to work any better than placebo. Patients think they are helped by alternative medicine. Placebos, by definition, do “please” patients. We would all like to please our patients, but we don’t want to lie to them. Is there a compromise? Is there a way we can ethically elicit the same placebo response that alternative theorists elicit by telling their patients fairy tales about qi, subluxations, or the memory of water?

Psychiatrist Morgan Levy has written a book entitled Placebo Medicine. It’s available free online. In it, he makes an intriguing case for incorporating the best alternative medicine placebo treatments into mainstream medicine.

In a light, entertaining style, he covers the placebo effect, suggestibility, and the foibles of the human thought processes that allow us to believe a treatment works when it doesn’t.

“Thinking like a human” is not a logical way to think but it is not a stupid way to think either. You could say that our thinking is intelligently illogical. Millions of years of evolution did not result in humans that think like a computer. It is precisely because we think in an intelligently illogical way that our predecessors were able to survive… [by acting on quick assumptions rather than waiting for comprehensive, definitive data]… We have evolved to survive, not to play chess.

He offers evidence from scientific studies indicating that belief in a treatment and the power of suggestion can have actual physiologic consequences such as production of endorphins or changes on brain imaging studies. He spices his narrative with colorful stories, including anecdotes from his own sex life and an impassioned plea (tongue in cheek?) for everyone to drink coffee for its proven benefits. (more…)

Posted in: Acupuncture, Book & movie reviews, Medical Ethics

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Risks Associated With Complementary And Alternative Medicine (CAM): A Brief Overview

Having grown up on a dairy farm, I am one of the least likely people to object to the deification of yogurt. However, as a critical thinker, I cannot help but resist the idea (promoted by some health sites) that probiotics are a reasonable alternative to chemotherapy in the treatment of colon cancer. And there are many other equally unhelpful claims being made all the time. Fish oil for ALS anyone?

What amazes me about the “cherry yoga” camp (as my friend Bob Stern likes to call it), is that they aggressively market CAM as “harmless” and “natural.” They point to the warning labels and informed consents associated with science-based medicines as evidence that the alternative must be safer. In reality, many alternative practices are less effective, and can carry serious risks (usually undisclosed to the patient). For your interest, I’ve gathered some examples of risks associated with common alternative practices that have been described by the CDC and in the medical literature:
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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy

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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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Differences Of Opinion

After my fairly recent awakening from shruggieness  (i.e. a condition in which one is largely unaware of or uninterested in CAM) I decided to discuss my concerns about pseudoscience with my friends. One particular friend is a nationally recognized physician who believes in the importance of accurate health information and the promotion of science. However, he sees no urgent need to warn people against snake oil, and so long as it’s correctly labeled he doesn’t seem to mind it co-existing with scientific alternatives.

My friend and I had dinner a few weeks ago, and our conversation was both animated and disappointing. I somehow felt inadequate in conveying my objections (both ethical and scientific) to the promotion of pseudoscience. My best explanations were met with cheerful rebuttals, and while not intellectually convincing to me, those retorts satisfied my friend just fine. I guess the bottom line was that he was more interested in maintaining his position than reconsidering it… and so it left me feeling rather frustrated and a little sad.
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Posted in: 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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Healing But Not Curing

Last week I discussed the book Healing, Hype, or Harm? edited by Edzard Ernst. I was particularly struck by one of the essays in that book: “Healing but not Curing” by Bruce Charlton, MD, a reader in evolutionary psychiatry at the Department of Psychology of the University of Newcastle upon Tyne.

Charlton proposes a new way of looking at CAM. He describes three common attitudes:

  •  CAM does good and should be integrated with orthodox medicine. 
  • CAM is worthless and should be discarded.
  •  CAM may or may not do good and this should be decided using science.

He rejects all three. In his view,

  •  Alternative therapies do good.
  •  From a strictly medical perspective they are worthless.
  •  They should not be integrated with orthodox medicine.
  •  Because they are explained non-scientifically, they cannot be evaluated using the criteria of medical science.

He suggests that alternative therapies be regarded as spiritual practices. They are about making people feel better (‘healing’) not about mending their dysfunctional brains and bodies (‘curing’). (more…)

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When Further Research Is NOT Warranted: The “Wisdom of Crowds” Fallacy

Most scientific research studies have at least one thing in common: the conclusion section ends with, “further research is warranted.” I’d say it’s about as common as the “talk to your doctor” disclaimer in TV ads for pharmaceutical products. And in a way, they both serve the same purpose. They’re a “CYA” move.

What does “further research is warranted” mean in plain English? I think it can be roughly translated: “My research study is not of the size or scope to fully explain all the phenomena described in this article. Therefore, draw conclusions beyond the data and study methods at your own risk. And yeah, my work is important and cool – so people should study it further.”

Of course, the first two sentences are reasonable – we should always remember not to draw conclusions beyond the information provided by the data we’ve collected (even though that’s about as challenging as getting a beagle not to eat a table scrap in an empty room). The real problem is the third sentence. Is the research promising enough to require further investment? How are we to know if further research is indeed warranted? I would argue that it should not be based solely on the subjective opinions of the researchers nor the popularity of the research topic to the general public. (more…)

Posted in: Clinical Trials, General, Science and Medicine

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