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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?

Posted in: Medical Ethics, Science and Medicine

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Acupuncture – Disconnected from Reality

The primary goal of science-based medicine (SBM) is to connect the practice of medicine to the best currently available science. This is similar to evidence-based medicine (EBM), although we quibble about the relative roles of evidence vs prior plausibility. In a recent survey 86% of Americans said they thought that science education was “absolutely essential” or “very important” to the healthcare system. So there seems to be general agreement that science is a good way to determine which treatments are safe and work and which ones are not safe or don’t work.

The need for SBM also stems from an understanding of human frailty – there are a host of psychological effects and intellectual pitfalls that tend to lead us to wrong conclusions.  Even the smartest and best-meaning among us can be lead astray by the failure to recognize a subtle error in logic or perception. In fact, coming to a reliable conclusion is hard work, and is always a work in progress.

There are also huge pressures at work that value things other than just the most effective healthcare. Industry, for example, is often motivated by profit. Institutions and health care providers may be motivated by the desire for prestige in addition to profits. Insurance companies are motivated by cost savings. Everyone is motivated by a desire to have the best health possible – we all want treatments that work safely, often more so than the desire to be logical or consistent. And often personal or institutional ideology comes into play – we want health care to validate our belief systems.


Posted in: Acupuncture, Science and Medicine

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Shame on PBS!

I used to have a high opinion of PBS. They ran excellent programs like Nova and Masterpiece Theatre and I felt I could count on finding good programming when I tuned into my local PBS channel. No more.

It was bad enough when they started featuring Deepak Chopra, self-help programs, and “create your own reality” New Age philosophy, but at least it was obvious what those programs were about. What is really frightening is that now they are running programs for fringe medical claims and they are allowing viewers to believe that they are hearing cutting edge science.

Neurologist Robert Burton has written excellent articles for pointing out the questionable science presented by doctors Daniel Amen and Mark Hyman in their PBS programs. Please click on the links and read what he wrote. These programs are being shown during fundraising drives as if they were examples of the best PBS has to offer. (more…)

Posted in: Science and the Media

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How not to think

Thankfully, I don’t receive all that much blog-related mail.  But this weekend I received several communications about a piece in popular liberal blog.  The piece is (ostensibly) about Lyme disease, which coincidentally happens to be one of the topics of my first post here at SBM.  In fact, I’ve written about Lyme disease a number of times, and Dr. Novella has a very good summary of the controversy at one of his other blogs.  Since we’ve discussed this so many times, I won’t be reviewing the entire controversy, but looking at this particular blog post to examine how our personal experiences and errors in reasoning can distort our view of reality.

The topic of Lyme disease has come up recently in the press, and as the weather improves, cases in the northeastern U.S. should start to increase soon.  Just as a reminder, so-called “chronic” Lyme disease is not Lyme disease at all.  Lyme disease can have early and late manifestations, none of which correspond to the vague, protean symptoms labeled as “chronic” by some.  The disease is often diagnosed without resort to objective evidence, such as reliable, positive lab tests.  But let’s look at the blog post in question and see what’s there.


Posted in: Diagnostic tests & procedures, Science and Medicine

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When fraud undermines science-based medicine

The overriding them, the raison d’être if you will, of this blog is science-based medicine. However, it goes beyond that in that we here at SBM believe that science- and evidence-based medicine is the best medicine. It’s more than the best medicine, though; it’s the best strategy for medicine to improve therapy for our patients. We frequently contrast science-based medicine with various forms of “complementary and alternative medicine,” specifically pointing out that SBM changes its practices as new science and new evidence mandates it while CAM tends to rely on ancient, vitalistic, pre-scientific or pre-modern scientific beliefs about how disease occurs as the basis for its therapies. Although it may be painfully slow and frustrating at times and even though there may be major stumbles along the way, the overall course of SBM over the last century has in general been to produce ever more effective therapies and to discard therapies that are either ineffective or whose risk-benefit ratios are insufficiently favorable. The one single most important thing behind the advancement of medicine is good science.

That’s why I really, really hate scientific fraud, and I’m really, really upset, perhaps even more so than Dr. Atwood, over the discovery last week of what is arguably one of the most massive scientific frauds in medical history. It doesn’t matter that Dr. Atwood is an anaesthesiologist and I am not, meaning that the specific scientific fraud unearthed, which was perpetrated by an anesthesiologist studying multimodal anesthesia, as reported in Anesthesiology News, the Wall Street Journal, and the New York Times. I am a surgeon, and the relief of surgical pain in my patients is an important part of my practice. If the scientific basis of what my colleagues in anesthesiology do before, during, and after my operations is called into doubt, I have to wonder if I am giving my patients the best surgical care. Aside from that, there is the intellectual outrage I feel as a result of seeing science and patients betrayed in such a systematic and blatant manner.

Posted in: Clinical Trials, Health Fraud, Pharmaceuticals, Science and Medicine, Surgical Procedures

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I Work with Steve Martin

Partly as an antidote to the previous, depressing post, and partly because it is so deserving of exposure, I now present—verbatim except for names and other ‘identifiers’—a recent email exchange between one of my colleagues and a correspondent. It has nothing to do with SBM. My colleague, known to his friends as T-Bone, is the reluctant owner of a vacation house in Florida. He must rent it as much as possible, since no one is willing to buy it. He gets frequent queries from potential renters, but usually not of the sort illustrated below. T-Bone is a very funny person. This exchange reminds me of the pieces that Steve Martin did for the back page of the New Yorker a few years ago.


From: Carlos Buffett <[email protected]>

To: T-Bone Seidler

Sent: Friday, January 23, 2009 11:12 AM

Subject: HouseHere inquiry about LandSilence 2468 from Carlos Buff 

Dear T-Bone Seidler,

Carlos Buff has sent the following inquiry about property number 2468 in LandSilence. To reply to this inquiry, simply call the phone number contained in the inquiry or reply to this e-mail.


Posted in: Humor

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Scientific Fraud Hits Home

Last week the story broke that Scott Reuben, an anesthesiologist and clinical researcher at Baystate Medical Center in Springfield, MA, had falsified data in at least 21 publications over a period of at least 12 years—making it one of the most enduring examples of scientific fraud in memory. Almost all of Reuben’s papers had reported innovative methods for providing post-operative pain relief (analgesia); many of them involved ‘multimodal’ regimens for painful orthopedic procedures such as spinal fusions and total knee replacements. Recent papers reported regimens that included celecoxib (Celebrex) and pregabalin (Lyrica), both made by Pfizer. Much of Reuben’s research had been funded by Pfizer, and Reuben has been a member of the Pfizer speaker’s bureau (that information is included because the reader would otherwise wonder, but there is no indication that Pfizer has been intentionally involved in Reuben’s fraud).

I will not discuss this case in detail; look for a more comprehensive piece on SBM next week. Rather, I present it now to offer a local example of how such a breach of trust affects those who rely on clinical research to inform their care of patients.


Posted in: Clinical Trials, Health Fraud, Pharmaceuticals, Science and Medicine

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Evidence-Based Legislation? Lessons From Abroad

President Obama appears to be refreshingly pro-science in his outlook, publicly lauding objectivity and careful analysis. He has even been credited with saying that “we need evidence-based legislation” in regards to public policy. The New York Times reports:

Agencies will be expected to pick science advisers based on expertise, not political ideology, the memorandum said, and will offer whistle-blower protections to employees who expose the misuse or suppression of scientific information.

The idea, the president said in remarks before an audience of lawmakers, scientists, patients advocates and patients in the East Room, is to ensure that “we make scientific decisions based on facts, not ideology”: a line that drew more applause than any other.

But when it comes to healthcare reform, many policy decisions put us in uncharted territory, with intelligent arguments on both sides of many legislative options and no American historical frame of reference to help us determine the best course of action. In times like these, perhaps the best we can do (to promote “evidence-based legislation”) is to study similar policy decisions made by our Canadian and European counterparts.


Posted in: Politics and Regulation

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The GAO Report on Supplement Regulation

We advocate for Science-Based Medicine partly because science incorporates various generic intellectual virtues to which everyone should aspire. These include logical and clear thinking, unambiguous definitions, and internal consistency. In fact it is demonstrably true that opposing science often equates to promoting muddied and sloppy thinking, ambiguous language, and self-contradiction.

Last week I wrote about that latter virtue – consistency – and its lack when dealing with regulating physicians vs regulating so-called complementary and alternative medicine (CAM). In fact CAM exists, in my opinion, specifically to create a double-standard to disguise contradictory standards. It is institutionalized compartmentalization to minimize public cognitive dissonance.

This week, as promised, I will discuss how the same double standard has been made to apply to the regulation of supplements vs pharmaceuticals. The recently published Government Accountability Office (GAO) report on supplement regulation by the FDA brings this to light.


Posted in: Herbs & Supplements, Politics and Regulation

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The China Study

One of our readers asked that we evaluate a book I had not previously heard of: The China Study: Startling Implications for Diet, Weight Loss and Long-Term Health, by nutrition researcher T. Colin Campbell, PhD, with his non-scientist son Thomas M. Campbell II. The China Study was an epidemiologic survey of diet and health conducted in villages throughout China and is touted as “the most comprehensive study of nutrition ever conducted.” The book’s major thesis is that we could prevent or cure most disease (heart disease, cancer, diabetes, autoimmune diseases, bone, kidney, eye and other diseases) by eating a whole foods plant-based diet, drastically reducing our protein intake, and avoiding meat and dairy products entirely.

Opinions of the book

There’s a lot of praise for this book on the Internet. It was named VegNews Book of the Year. PETA loves it (not surprisingly). Heather Mills McCartney calls it inspirational. It was featured on and endorsed by two of her favorite doctors: Mehmet Oz and Dean Ornish. Its author was even interviewed on Coast to Coast AM.

But I also found this critical review which makes some excellent points and accuses the authors of misrepresenting the findings of the study. And this commenter on an forum also charges Campbell with misrepresenting the data from the study and points out numerous flaws in his reasoning.

Problematic references

I didn’t look at the praise or criticism of others until after I read the book, and the following represents my independent impressions. I approached the book as I do any book with scientific references: I read until I come across a statement of fact that strikes me as questionable and then I check the references given for the statement. This immediately got me off on the wrong foot with this book. In the first chapter I found the statement:

Heart disease can be prevented and even reversed by a healthy diet. (more…)

Posted in: Book & movie reviews, Cancer, Nutrition

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