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Archive for Medical Ethics

True Informed Consent Is Elusive

Most of us would agree that doctors should not treat patients without their consent, except in special cases like emergency care for an unconscious patient.  It’s not enough for doctors to ask “Is it OK with you if I do this?” They should get informed consent from patients who understand the facts, the odds of success, and the risk/benefit ratio of treatments. The ethical principle of autonomy requires that they accept or reject treatment based on a true understanding of their situation and on their personal philosophy. Numerous studies have suggested that patients are giving consent based on misconceptions. There is a failure of communication: doctors are not doing a good job of providing accurate information and/or patients are failing to process that information. I suspect it is a combination of both.

An article in The New England Journal of Medicine reports that while the great majority of patients with advanced lung cancer and colorectal cancer agree to chemotherapy, most of them have unreasonable expectations about its benefits. For some cancers chemotherapy can be curative, but for metastatic lung or colorectal cancer it can’t. For these patients, chemotherapy is only used to prolong life by a modest amount or to provide palliation of symptoms. Patients were asked questions like “After talking with your doctors about chemotherapy, how likely did you think it was that chemotherapy would… help you live longer, cure your cancer, or help you with problems you were having because of your cancer?” A whopping 69% of lung cancer patients and 81% of colorectal cancer patients believed it was likely to cure their cancer, and most of these thought it was very likely. (more…)

Posted in: Cancer, Medical Ethics, Pharmaceuticals

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The Trial to Assess Chelation Therapy: Equivocal as Predicted

The ill-advised, NIH-sponsored Trial to Assess Chelation Therapy (TACT) is finally over. 839 human subjects were randomized to receive Na2EDTA infusions; 869 were randomized to receive placebo infusions. The results were announced at this weekend’s American Heart Association meeting in Los Angeles. In summary, the TACT authors report a slight advantage for chelation over placebo in the “primary composite endpoint,” a combination of five separate outcomes: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina:

 

Although that result may seem intriguing, it becomes less so when the data are examined more carefully. First, it barely achieved the pre-ordained level of statistical significance, which was P=.036. Second, none of the individual components of the composite endpoint achieved statistical significance, and most of the absolute difference was in coronary revascularization–which is puzzling:

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

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Stem cell therapy regulation plays catch up

The burgeoning U.S. stem cell therapy industry was delivered a setback last month in the form of a U.S. District Court injunction against use of the “Regenexx™ Procedure,” which purports to treat joint, muscle, tendon or bone pain due to injury or other conditions. The court agreed with the FDA that the cell product used in the procedure is both a drug and a “biological product” subject to FDA regulation. Because a similar process is used in other stem cell therapies the decision increases the possibility that the FDA will take a like position in other cases.

The general term “stem cell therapy” comprises an array of treatments which range from the clinically proven to quackery. On one end of the spectrum is blood stem cell transplantation to treat diseases and conditions of the blood and immune system. On the other lies the kind of stem cell therapy tourism addressed by both Steve Novella (here and here) and Orac (here and here), which involves the injection of what may, or may not be, stem cells from what may, or may not be, humans. In between fall therapies which are plausible and have promise but have not been adequately tested in clinical trials. There is a concern that these therapies are being oversold by clinics which charge thousands of dollars (not reimbursed by insurance) to treat conditions including multiple sclerosis, musculoskeletal pain, and cardiac disease.

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

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The future of cancer therapy?

I was contemplating writing a post along the same lines as Harriet’s post about evolutionary medicine last week, but then on Sunday morning I saw an article that piqued my interest. Sorry, Harriet, my response, if I get to it, might have to wait until next week, although we could always discuss the usefulness (versus the lack thereof) of evolutionary medicine over a beer or two at The Amazing Meeting in a few days. In the meantime, this week’s topic will revisit a topic near and dear to my heart, a topic that I tend to view (sort of) in a similar way as Harriet views evolutionary medicine, namely personalized medicine or the “individualization” of treatments. It’s a topic I’ve written about at least twice before and that Brennen McKenzie wrote about just last week. In essence, we both pointed out that when it comes to “complementary and alternative medicine” (CAM) or “integrative medicine” treatments for various conditions and diseases, what CAM practitioners claim to be able to do with respect to “individualized care” is nonsense based on fantasy. Science-based medicine already provides individualized care, but it’s individualized care based on science and clinical trials, not tooth fairy science.

Serendipitously, this point was driven home over the weekend in an article by Gina Kolata in the New York Times entitled In Treatment for Leukemia, Glimpses of the Future. While the story is basically one long anecdote that shows what can be done when new genomic technologies are applied to cancer, it also shows why we are a very long way from the true “individualization” of cancer care. It also turns out that I’ve discussed the same basic story before, but here I’ll try to discuss it in a bit more detail.
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Posted in: Cancer, Clinical Trials, Medical Ethics

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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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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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Funding CAM Research

Paul Offit has published a thoughtful essay in the most recent Journal of the American Medical Association (JAMA) in which he argues against funding research into complementary and alternative therapies (CAM). Offit is a leading critic of the anti-vaccine movement and has written popular books discrediting many of their claims, such as disproved claim for a connection between some vaccines or ingredients and risk of developing autism. In his article he mirrors points we have made here at SBM many times in the past.

Offit makes several salient points – the first being that the track record of research into CAM, mostly funded by the NCCAM, is pretty dismal.

“NCCAM officials have spent $375,000 to find that inhaling lemon and lavender scents does not promote wound healing; $750,000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390,000 to find that ancient Indian remedies do not control type 2 diabetes; $700,000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406,000 to find that coffee enemas do not cure pancreatic cancer.”

The reason for the poor track record is fairly simple to identify – by definition CAM includes treatments that are scientifically implausible, which means there is a low prior probability that they will work. If the treatments were scientifically plausible then they wouldn’t be alternative.

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Posted in: Clinical Trials, Herbs & Supplements, Medical Ethics, Politics and Regulation, Science and Medicine

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A surprising article about “integrative” medicine in The New England Journal of Medicine vs. “patient-centered” care

The New England Journal of Medicine (NEJM) is published on Thursdays. I mention this because this is one of the rare times where my owning Mondays on this blog tends to be a rather large advantage. Fridays are rotated between two or three different bloggers, and, as awesome as they are as writers, bloggers, and friends, they don’t possess the rabbit-like speed (and attention span) that I do that would allow me to see an article published in the NEJM on Thursday and get a post written about it by early Friday morning. This is, of course, a skill I have honed in my not-so-super-secret other blogging identity; so if I owned the Friday slot I could pull it off. However, the Monday slot is good enough because I’ll almost always have first crack at juicy studies and articles published in the NEJM before my fellow SBM partners in crime, unless Steve Novella managed to crank something out for his own personal blog on Friday, curse him.

My desire to be the firstest with the mostest when it comes to blogging about new articles notwithstanding, as I perused the table of contents of the NEJM this week, I was shocked to see an article that made me wonder whether the editors at NEJM might just be starting to “get it”—just a little bit—regarding “integrative” medicine. As our very own Mark Crislip put it a little more than a week ago:

If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.

Lately, though, I’ve been more fond of a version that doesn’t use fancy words like “instantiate”:

If you integrate fantasy with reality, you don’t make the fantasy more real. You temporarily make your reality seem more fantasy-based, but reality always wins out in the end.

The part about the cow pie needs no change, although I think ice cream works a bit better than apple pie. Your mileage may vary. Feel free to make up your own metaphor inspired by Mark’s.

In any case, in the Perspective section, I saw three articles about “patient-centered” care:
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Posted in: Cancer, Medical Academia, Medical Ethics

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The Marino Center for Integrative Health: Hooey Galore

Two weeks ago I promised that I would discuss the Marino Center for Integrative Health, identified in the recent Bravewell report as having a “hospital affiliation” with the Newton-Wellesley Hospital (NWH) in Newton, Massachusetts, which is where I work. I also promised in that post that I’d provide examples of ‘integrative medicine’ practitioners offering false information about the methods that they endorse. I’d previously made that assertion here, and Jann Bellamy subsequently discussed its legal and ethical implications here. The Marino Center is a wellspring of such examples.

A Misleading ‘Affiliation’

Let’s quickly dispel the “hospital affiliation” claim. According to the Marino Center website:

Hospital Affiliations

In support of our services and to ensure that our patients have access to exceptional tertiary care, the Marino Center maintains deeply established relationships and affiliations for referrals and admitting privileges with major medical facilities in the Boston area.

The Marino Center:

  • Is a proud member of the Partners Healthcare family
  • Is affiliated with Newton Wellesley Hospital
  • Makes referrals to Mass General Hospital, Dana Farber, Children’s Hospital and more

Well, it wouldn’t surprise me if the Marino Center is a ‘member’ of the Partners Healthcare family, which includes not only the Newton-Wellesley Hospital, but lesser known entities such as the Massachusetts General Hospital and the Brigham and Women’s Hospital. After all, there are already unfortunate pseudomedical schemes involving Partners entities, such as the Osher Center for Complementary and Integrative Medical Therapies and, even under my own roof (I shudder as I write this), a Reiki Workshop. Nevertheless, it’s telling, I hope, that not only does the Marino Center fail to appear under any list of Partners affiliates, Community Health Partnerships, Wellness, Prevention, or any other conceivable category, but it fails to yield a single ‘hit’ when entered as a search term on the Partners website (the term ‘integrative’ yields seven hits, but none appears to be about ‘CAM,’ except possibly for an RSS feed that I’ve no patience to peruse. Is it possible that Partners is embarrassed by the Osher Center? I hope that, too).

I’ve previously asserted that the NWH is not affiliated with the Marino Center, other than that some Marino Center physicians have been—against my judgment, not that I was consulted—granted hospital staff privileges. I made this assertion in my original Bravewell post a couple of weeks ago, after having questioned the NWH Chief Medical Officer, Dr. Les Selbovitz, who verified it; nothing on the NWH website suggests otherwise.

I’ve no reason to doubt the Marino Center’s third bullet above, “makes referrals to Mass General Hospital,” etc., but this is something that any physician can do, regardless of affiliation. I suspect that if there were an ‘integrative hospital‘ in Boston, reason forbid, the Marino Center would make referrals to it.

False and Misleading Information about ‘Services’

Let’s get to the meat of the problem.

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Posted in: Acupuncture, Homeopathy, Medical Ethics, Science and Medicine, Science and the Media

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Perpetual Motion: More on the Bravewell Report

I’m not here to convince people that we are right, although it would be nice if it turned out that way. I’m here to tell the truth and let readers decide for themselves.

— Kimball Atwood, Science Based Medicine, Bravewell Bimbo Eruptions

I had been too inarticulate to formulate what is essentially my approach to this blog: to tell the truth. That would appear to be simple enough. Of course it gets down to what constitutes the truth, and whether you can handle the truth.

What is truth, small ’t’? Truth with a big ’T’ is provided by belief systems that originate in a personal epiphany and you suddenly understand the meaning of life, the universe and everything. Or conjure up reiki or chiropractic. I suspect I was either born without the part of the brain that allows me to appreciate the mystical/spiritual aspects of human existence, or perhaps it was my upbringing. Probably a bit of both, although having raised two kids in the eternal nurture/nature debate has swayed me heavily towards the nature side of the fence. I bet I was born that way. But I am totally tone deaf to issues of spirituality and the surrounding issues of big ’T’ Truths, so I am going to stick to the little ’t’ truths. (more…)

Posted in: Health Fraud, Medical Academia, Medical Ethics

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