Archive for Medical Ethics

IRBs, Conflicts of Interest, and Witch Hunts

When beginning a discussion of a controversial topic I like to establish the common ground upon which most or all people can agree. Everyone seems to agree that real conflicts of interest in medical research and practice is a bad thing and steps should be taken to minimize, eliminate, and illuminate any such conflicts. The controversy revolves around what constitutes a real conflict of interest.

There is broad agreement that researchers should not have a personal financial stake in the outcome of their own research – they should not make more money if their research is positive than if it’s negative. That creates a clear and powerful bias.  There is also now broad agreement and adoption of standards that speakers, authors, and researchers should disclose any potential conflicts of interest – primarily the source of their funding. If someone is being paid by a drug company to say that their drug is effective for a particular disease, they should disclose that up front.

These same standard are now being applied to IRBs – institutional review boards, and that seems apprpriate. Every institution that does biomedical research must have an IRB, which is a committee of appropriate professionals (and there are rules as to the IRB’s constitution) that review all human research proposals to make sure they meet ethical guidelines and that subjects are adequately protected. This is a good system that generally works.


Posted in: Medical Academia, Medical Ethics, Politics and Regulation

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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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Lies, Damned Lies, and ‘Integrative Medicine’

Last week, two events took place in Washington that ought to inspire trepidation in the minds of all who value ethical, rational, science-based medicine and ethical, rational, biomedical research. One was the Senate Panel titled Integrative Care: A Pathway to a Healthier Nation, previously discussed by my fellow bloggers David Gorski, Peter Lipson, and Steve Novella, and also by the indefatigable Orac (here and here); the other was the “Summit on Integrative Medicine and the Health of the Public” convened by the Institute of Medicine (IOM) and paid for by the Bravewell Collaborative, previewed six weeks ago by fellow blogger Wally Sampson. This post will make a few additional comments about those meetings.

Senator Harkin and the Scientific Method

Thanks to Dr. Lipson, I didn’t have to listen to the Senate Panel video to find out that Senator Tom Harkin (D-Iowa) made this statement of disappointment regarding his own creation, the National Center for Complementary and Alternative Medicine (NCCAM):

One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving. (from last week’s hearings, time marker approx. 17:20)

Are scientists at the NIH really too afraid of Harkin to explain to him how science works? Apparently so. Otherwise Harkin might learn that his statement is more wrong-headed than it would be for one of us to complain that the Supreme Court ought to assume that a defendant is guilty until proven innocent, rather than the other way around. In scientific inquiry, for those who don’t know, good experimental design is always directed at disproving a hypothesis, even one that pleases its investigator. The rest of Harkin’s sentiment—“seeking out and approving”—is incoherent.

The Selling of ‘Integrative Medicine': Snyderman Trumps Weil

Spin doctors shilling for ‘integrative medicine,’ which the NCCAM defines as “combining treatments from conventional medicine and CAM,” appear to have now decided that subtler language is more likely to sell the product. We’ve previously seen an example offered by ‘integrative’ Mad Man Andrew Weil:


Posted in: Medical Academia, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine, Science and the Media, Vaccines

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Colorado is Nearer to Promoting Naturopathic Pseudomedicine—Aided by the Colorado Medical Society

This week we’ll take a break from lambasting the National Center for Complementary and Alternative Medicine, as worthy as that task is, in order to confront some of the latest events involving the pseudomedical cult that calls itself “naturopathic medicine.”* Intrepid nurse and anti-healthfraud activist Linda Rosa reports that Colorado is dangerously close to becoming the next state to endorse “NDs” as health care practitioners, and Scott Gavura of Science-Based Pharmacy called my attention to a report that British Columbia is considering enlarging the scope of practice for NDs, who are already licensed there, and that Alberta is on the verge of licensing them. In each case, those whom the public trusts to make wise decisions have betrayed their ignorance of both pseudomedicine and the realities of governmental regulation.

To explain why, it will first be necessary to make a few assertions, which are linked to developed arguments where necessary:


Posted in: Health Fraud, Herbs & Supplements, Medical Ethics, Nutrition, Politics and Regulation, Public Health, Science and Medicine

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Obama and Stem Cells

In 2001 George Bush signed an executive order banning federal funding for embryonic stem cell research, except for those lines that were already established. As a result such research ground to a halt in the US.

While the order was presented as a compromise, the effect was chilling in its application. No researcher receiving federal dollars (even for a separate project) could do embryonic stem cell research, except on the approved lines.  Institutions could not risk losing federal grants and so had to purge themselves of any banned research. The approved lines did not turn out to be as useful as was originally claims, and they became progressively obsolete as new techniques were being developed through state and private funding.

It is impossible to measure the effect that Bush’s ban had on ultimate scientific progress in this area. It is not just that we lost eight years – expertise in a cutting-edge scientific area can be a tenuous cultural and institutional thread, once broken it is difficult to recreate.

We will hopefully have a chance to find out. It was expected that one of the first measures of the Obama administration would be to lift the federal ban. In fact, I am a bit surprised it has not happened already. But it seems it soon will – insiders are saying that Obama plans to lift the ban soon.


Posted in: Medical Ethics, Politics and Regulation

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Yes We Can! We Can Abolish the NCCAM! Part III

A Reminder…

…of why we keep harping on this. A couple of days ago The Scientist reported that the “economic stimulus package” may include a windfall for the NIH:

Senate OKs big NIH bump

Posted by Bob Grant

[Entry posted at 4th February 2009 04:12 PM GMT]

The US Senate, which is furiously debating the details of the economic stimulus package making its way through Congress, passed an amendment yesterday (Feb. 3) to add $6.5 billion in National Institutes of Health funding on top of the $3.5 billion already allotted to the agency in the bill…

Exactly how an NIH funding increase will be spent remains to be determined.

You can bet that if this happens, the NCCAM will be licking its chops for some of that lettuce. Let’s continue to explore why it shouldn’t get any…


Posted in: Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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Yes We Can! We Can Abolish the NCCAM!

…and in so doing, President Obama, you and we would abolish the NIH’s second most prodigious squanderer of precious research funds! Surprise: The National Cancer Institute (NCI) spends slightly more on humbug than does the Center created for that purpose. All told, the NIH squanders almost 1/3 of a billion dollars per year promoting pseudoscience.

I’ve decided to add my two cents to the recent groundswell of demand to stop this sordid and embarrassing chapter in NIH history—even more sordid and embarrassing, in its way, than NIH researchers being on the take: pseudoscience is exactly antithetical to the mission of the NIH, which sponsors it repeatedly, officially, overtly, unethically, and dangerously. At least, in the case of Big Pharma greasing the palms of NIH researchers, those involved generally prefer to obscure the transactions, as good sense and traditional mores dictate.

My comments will be somewhat different from others’, not because I disagree with theirs but because it’s worthwhile to stress points that have not been stressed or even mentioned. I won’t bother to justify the assertion that “promoting pseudoscience” is an accurate description of what the NCCAM and the OCCAM do, because I’ve done that several times in the past, beginning here and here, and more recently here. I will plagiarize myself a bit, but only to introduce certain points.


Posted in: Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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Guest Book Review of “Complementary and Alternative Medicine: Ethics, the Patient, and the Physician”

The following book review was written not by your poster (although I’ve added the hyperlinks), but by his friend Cees Renckens, who is a gynecologist in the Netherlands and the chairman of the Dutch Society against Quackery. A short bio of Dr. Renckens, including references to several articles in English, follows the review. Most impressive to me is that he is, as far as I know, the first and only person in the world to have earned a PhD in a field that describes much of the content here at Science-Based Medicine: the rational evaluation of anomalous and implausible medical practices.

For several years, Dr. Renckens and the Dutch Society have been embroiled in a disturbing legal case involving freedom of speech. This was previously mentioned on SBM by astute reader Dr. Peter Moran. According to Dr. Renckens, the Dutch Supreme Court will issue its final judgment of the case at the end of February.


Complementary and Alternative Medicine: Ethics, the Patient, and the Physician. Edited by Lois Snyder, 241 pp, $69.50, Totowa NJ, Humana Press (2007). ISBN 58829-584-2. 

Reviewed by Cees N. M. Renckens, MD, PhD

During the second half of the 20th century, the Moerman anti-cancer diet was very popular in the Netherlands. Moerman was a family physician with no training in oncology or nutrition. He kept carrier pigeons and believed that his birds never got cancer. Therefore he developed a diet based on food for carrier pigeons. He had no contact with oncologists, nutritionists or other physicians. The Inspector for Public Health for his area was of the opinion that Moerman had “serious medical-ethic defects.”

Add to this example the fact that “alternative” physicians appear to be successful in presenting their approach as highly ethical, with its respect for old wisdom, for the ideas and peculiarities of their patients, and for treatments borrowed from Ayurvedic, Chinese, Tibetan and other third world medical systems, all of which can be classified as backwards, and you can understand why my interest was immediately aroused when I learned that a book had been issued with the title Complementary and Alternative Medicine. Ethics, the Patient and the Physician.

Finally, I thought, a look through ethical glasses at the deceit, at the admissibility of shoddy scientific research of “alternative” treatments, and perhaps a discussion of the necessary rigor of academic medicine and about how to deal with those who reject such rigor. When, in a short review in the Mayo Clinic Proceedings, the book was judged to be “excellent,” I dispelled my dislike of the rather high price and ordered it. 


Posted in: Book & movie reviews, Medical Academia, Medical Ethics, Science and Medicine

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The Weekly Waluation of the Weasel Words of Woo #9


Can y’believe it? The W^5/2™, that cesspool of Afflicted Sophistry and Festering Fallacy—not to say that wellspring of Awesome and Absolutely Annoying (Cloying) Alliteration© and that Mother of all Maddening Mixed Metaphors and Sundry Similitudes®—is back! Yup, like the proverbial phoenix rising from the ashes of near-terminal procrastination, and due to overwhelming popular demand, the W^5/2 is reborn!!! Well, it also might have something to do with yer faithful servant needing some time to put together a real paper or two…naaahh! But what the hay, let’s just dive right in and pretend that nothin’s changed, shall we?


Posted in: Cancer, Chiropractic, Faith Healing & Spirituality, Health Fraud, Humor, Medical Ethics

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Paternalism Revisited

Paternalism is out of fashion. Doctors used to have a parent-child relationship with their patients: they concealed the truth if they thought it was in the patient’s best interest, they dictated the treatment and did not have to justify it to the patient. “You have to take this pill because I’m the expert and I know what’s best; don’t ask questions.” Sort of like “You have to go to bed now – because I said so and because I’m the mommy.”

Some time in the 20th century we evolved to a different doctor-patient relationship, an adult-adult one in which the doctor shared expert knowledge and information with the patient and they cooperated to decide on the best treatment plan. The principle of patient autonomy became paramount and the patient gave informed consent to the chosen treatment.

It is generally accepted that this is all for the good. But is it really? In his book Intern: A Doctor’s Initiation, Sandeep Jauhar says, “Over time, my views on informed consent have evolved. I no longer view paternalism as suspiciously as I once did. I now believe that it can be a core component of good medical care.” (more…)

Posted in: Medical Ethics

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