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Archive for Medical Ethics

Legislating Ignorance

Child-GUN

Science is under attack, and not just from anti-vaccine celebrities and parents with degrees from Google University. Scientific illiteracy is being woven into the very fabric of our society through legislative assault. If you dismiss this as alarmist hyperbole, you haven’t been paying close enough attention.

Every day thousands of pediatric health care providers throughout the country provide safety advice to patients and their parents during routine health maintenance visits. As part of this important routine we ask a series of standard questions to assess the safety of our patients’ environment. Some of these questions are easy and straightforward, and some are more personal and potentially awkward for patients and their parents, including questions pertaining to sexual practices and preferences and psychosocial history. An important series of questions focuses on potential hazards in the home, such as how toxins and medicines are stored, how pools are secured against curious toddlers, and whether there are guns in the home and how they are stored and secured. Parents are usually appreciative of the advice we provide, and thankful for our concern and attention to these issues. Occasionally patients or parents are taken aback by some of these questions, and very rarely they prefer not to answer them (in my 20 years in practice, I can recall only one time this has occurred). We ask these questions because accidental injuries and deaths are common occurrences in the pediatric population, and there is good evidence that patients tend to follow the advice we provide our patients. (more…)

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

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The false dichotomies of CAM and “integrative medicine”

Falsedichotomy

A lot of medical specialties have throwaway newspapers/magazines that are supported by advertising and somehow mysteriously managed to show up for free in the mailboxes of practitioners. In my case, I’ve found myself on the subscription list for such papers about oncology, but also general surgery (I’m Board-certified as a general surgeon). When I have to recertify in about three years, it will be as a general surgeon, which was really fun to try to do last time after having specialized as a breast cancer surgeon, and will likely be even more fun next time, when I will be 10 years further out from my general surgery and surgical oncology training. In any case, that must be why, no matter where I end up working, sooner or later I end up receiving General Surgery News (GSN).

As throwaway professional newspapers go, GSN is not bad. However, occasionally it publishes op-ed articles that make me scratch my head or even tick me off with their obtuseness. Lately, apparently, it’s started some blogs. The one in particular that is the center of attention for this post is by Victoria Stern, is called “The Scope” and is billed as “exploring the lesser known sides of surgery.” Of course, it’s a bit odd that some of the first posts on this blog are about work hour restrictions and whether they leave new surgeons unprepared to practice surgery, the debate over breast screening, and what it takes to train expert surgeons, none of which are exactly “lesser known sides of surgery.” Work hour restrictions, in particular, have been discussed in surgery journals, at conferences, and among surgeons ad nauseam, particularly whether we are training a generation of surgeons unable to deal with the rigors of practicing surgery in the real world.
(more…)

Posted in: Critical Thinking, Medical Ethics

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Should the Incidental Discovery of Nonparentage be Disclosed?

badnews

“Ummm, I probably shouldn’t be telling you this.”

The July issue of Pediatrics, the official journal of the American Academy of Pediatrics, contains an extremely thought provoking article discussing the risks and benefits of disclosing an incidental finding of nonparentage during pediatric genetic testing. Nonparentage occurs when one, or very rarely both, of the social parents did not serve as source code for a child’s genetic programming, so to speak. Naturally, we aren’t talking about known adoptions but rather when the nonbiological parent is unaware of the fact that they did not contribute an egg or sperm.

Authors Marissa Palmor and Autumn Fiester, both bioethicists at the University of Pennsylvania’s Perelman School of Medicine, take the position of universal nondisclosure when nonparentage is discovered. They acknowledge the pro-disclosure arguments and, in my opinion, successfully rebut them. They go on to make a compelling recommendation for the incorporation of a universal nondisclosure clause into consent forms which states clearly that parental status will not be discussed. (more…)

Posted in: Medical Ethics

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The Truth?

Facepalm
Summertime and the living is easy. I am in Sunriver, Oregon for the week and I though, hilariously, that I would have plenty of time to write a post. Between the hiking, the biking, the golf, the food and the beer, there has been little time to sit in from of a keyboard. There may be no better place to spend a week if you like the outdoors, but they do not have internet on the hike around Paulia Lake. So while a caramel banana cake bakes for a dinner tonight, I have an hour or so churn out a post. Do not expect much.

One person’s ethics is another’s belly laugh, but in medicine ethics are formalized. The basic principles in the US are

  • Respect for autonomy – the patient has the right to refuse or choose their treatment (Voluntas aegroti suprema lex)
  • Beneficence – a practitioner should act in the best interest of the patient (salus aegroti suprema lex)
  • Non-maleficence – “first, do no harm” (primum non nocere)
  • Justice – concerns the distribution of scarce health resources, and the decision of who gets what treatment (fairness and equality).

These are guidelines, not mandated, but if you get an ethics consult in my institutions the above concepts are the framework within which the consult will be completed.

Patients can only be autonomous if they are given accurate, truthful information with which to make a decision about their treatments. You can’t lie to patients, but we all know how you phrase an idea can subtly alter the response. Do you say an 80% success rate or a 20% failure rate? I tend to say both. And not everyone can handle the unvarnished, blunt truth. Part of the art of medicine is trying to tell each patient the truth, the whole truth and nothing but the truth in a manner palatable for the individual patient. It is not easy and I am certain I do not always do a good job. (more…)

Posted in: Medical Ethics, Science and Medicine

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Consortium of Academic Health Centers for Integrative Medicine research conference disappoints even NCCAM

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link)

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link)

In May, the International Research Congress on Integrative Medicine and Health (IRCIMH) conference was held in Miami. In the words of its website, the conference was “convened by” the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM), “in association with” the International Society for Complementary Medicine Research. As CAHCIM chirped in this tweet: “Three days, 22 countries, 100 academic medical institutions, [and] 900 researchers, physicians, educators, and trainees…” Interestingly, despite the fact that “use of all appropriate … healthcare professionals and disciplines to achieve optimal health and healing” is part of CAHCIM’s definition of integrative medicine, actual CAM providers were barely visible among the conference committee bigwigs.

Emmeline Edwards, Ph.D., Director, Division of Extramural Research at the National Center for Complementary and Alternative Medicine (NCCAM), herself on the conference’s Program Committee, was decidedly underwhelmed. (NCCAM helped fund the conference. Additional funding information here.) After offering rather tepid congratulations to the organizers and participants, Dr. Edwards launched into a pointed, but very politely delivered, criticism of the research presented (emphasis mine):

The poster sessions offered a great opportunity to meet many new investigators engaged in exciting research in the field of integrative health. Reflecting on some highlights of these sessions, I was brought to the realization that we could strive for better balance in the science featured in the IRCIMH poster presentations. The clinical research posters outnumbered the basic research presentations 3:1, and research on mind and body strategies dominated the research landscape. One concern is that many clinical research projects were not developed from adequate mechanistic studies and, hence, the outcomes from these projects may not be very informative, provide a well-defined path for the next study, or give direction for future research programs.

How right you are, Dr. Edwards! We’ve been saying some of the same things here at SBM for years. We’ve noticed these very same problems in the organization you work for. Recently, as a matter of fact. (more…)

Posted in: Acupuncture, Basic Science, Clinical Trials, Energy Medicine, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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Dr. Oz and the Terrible, Horrible, No Good, Very Bad Day

Not Dr. Oz's usual television audience

Not Dr. Oz’s usual television audience

Dr. Mehmet Oz is one of the most well-known, and possibly the most influential medical doctor in America. The Dr. Oz Show is broadcast in 118 countries and reaches over 3 million viewers in the USA alone. When Oz profiles a product or supplement on his show, sales explode – it’s called “The Dr. Oz Effect”. Regrettably, Oz routinely and consistently gives questionable health advice, particularly when it comes to weight loss products, where Oz regularly uses hyperbolic terms like “miracle” for the products he profiles:

  • (On green coffee extract) — “You may think magic is make-believe, but this little bean has scientists saying they found the magic weight-loss for every body type.”
  • (On raspberry ketone) — “I’ve got the number one miracle in a bottle to burn your fat”
  • (On Garcinia cambogia) — “It may be the simple solution you’ve been looking for to bust your body fat for good.”

Dr. Oz has profiled so many dubious health strategies that “The Dr. Oz Effect” more accurately refers to the wasted time, effort and finances of any consumer that actually follows his health advice and purchases the steady stream of “miracles” that Oz endorses on his television show. Not surprisingly, Science-Based Medicine is probably Oz’s most persistent and tenacious critic. It’s not just that he’s high profile – it’s that Dr. Oz is a bona fide physician who ought to know better, but chooses to ignore science in favour of hyperbole. It’s the antithesis of what a health professional should be doing. And this is the root of the Oz problem: Oz can give good advice, but he regularly combines it with questionable statements and pseudoscience in a way that the casual viewer can’t distinguish between the science and the fiction. So when Oz calls something a miracle – people listen. Even when miracles show up several times per year. (more…)

Posted in: Health Fraud, Herbs & Supplements, Medical Ethics, Politics and Regulation

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Reiki: Fraudulent Misrepresentation

reiki-hands-pic

The Center for Integrative Medicine at the Cleveland Clinic sells reiki treatments (also here) to patients with cancer, fertility issues, Parkinson’s Disease and digestive problems, as well as other diseases and conditions. The Center’s website ad describes reiki as

a form of hands-on, natural healing that uses universal life force energy . . . [a] vital life force energy that flows through all living things. This gentle energy is limitless in abundance and is believed to be a spiritual form of energy. The Reiki practitioner is the conduit between you and the source of the universal life force energy. . . You may experience the energy as sensations such as heat, tingling, or pulsing where the practitioner places her hands on your body, or you may feel these sensations move through your body to other locations. This is the energy flowing into you.

This “universal life force energy” is described as having certain positive effects on one’s own energy, such as “energetically balancing” one physically, replenishing one’s supply of energy, improving distribution of that energy in the body, and dissolving “energy blockages.” It also increases one’s “vibrational frequencies,” although how these frequencies relate to one’s energy, or to anything else for that matter, is not made clear. (more…)

Posted in: Energy Medicine, Health Fraud, Homeopathy, Legal, Medical Ethics

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VacciShield: Pixie dust for an imaginary threat

vaccishield

I know by now I shouldn’t be, but I am still amazed by how readily so many people buy into the seemingly endless array of bogus sCAM nostrums. Many are marketed and hawked for the treatment or prevention of diseases that are poorly managed by science-based medicine. There are countless examples of dietary supplements that are purported to effectively treat back and joint pains, depression, anxiety, autism, chronic pain, and chronic fatigue; the list goes on and on. The lure for these treatments is at least understandable and, although frustrated that scientific literacy and rational thought loses out, I empathize with the desire to believe in them. On the other end of the spectrum is the even more ethically corrupt substitution of safe and effective treatments with products that are not. I encountered what I find to be possibly the most frightening and dangerous example of this recently at my practice. A family new to the area called to schedule a routine health-maintenance visit for their 5-year-old daughter. When our nurse reviewed the medical records the mother had faxed over, she noted that the child was unimmunized and explained to her that she would need to begin catch-up vaccinations. The mother matter-of-factly stated that her daughter was actually fully vaccinated with a vaccine alternative. She had received a series of homeopathic vaccines from a naturopath. I am not going to discuss this egregious example of sCAM here, though it was addressed in previous SBM posts.1,2 Instead I’d like to focus on another part of the sCAM spectrum. Here lies a form of sCAM that, in some ways, is even more difficult for me to comprehend. These are products invented, marketed, and sold solely for the treatment or prevention of fictitious diseases or problems that exist only in the realm of fantasy. (more…)

Posted in: Herbs & Supplements, Medical Ethics, Naturopathy, Nutrition, Science and Medicine, Vaccines

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Of the Trial to Assess Chelation Therapy, Bayes, the NIH, and Human Studies Ethics

An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means.
~ Henry K. Beecher

tact

A couple of weeks ago, Dr. Josephine Briggs, the Director of the National Center for Complementary and Alternative Medicine (NCCAM), posted a short essay on the NCCAM Research Blog touting the results of the Trial to Assess Chelation Therapy (TACT) (italics added):

The authors found that those receiving the active treatment clearly fared better than those receiving placebo. The accompanying editorial in the AHJ reminds readers about the value of equipoise and the need to “test our beliefs against evidence.”

Most physicians did not expect benefit from chelation treatment for cardiovascular disease. I readily admit, initially, I also did not expect we would find evidence that these treatments reduce heart attack, strokes, or death. So, the evidence of benefit coming from analyses of the TACT trial has been a surprise to many of us. The subgroup analyses are suggesting sizable benefit for diabetic patients—and also, importantly, no benefit for the non-diabetic patient. Clearly subgroup analyses, even if prespecified, do not give us the final answer. But it is also clear that more research is needed to test these important findings.

And TACT findings are indeed a reminder of the importance of retaining equipoise [sic], seeking further research aimed at replicating the findings, and neither accepting nor rejecting findings based on personal biases. The scientific process is designed to weed out our preconceived notions and replace them with evidence.

Dr. Briggs concluded:

So, TACT is a reminder—an open mind is at the center of the scientific method.

Dr. Briggs’s title was “Bayes’ Rule and Being Ready To Change Our Minds”, a reference to a recent editorial that had accompanied one of the TACT papers. That editorial, by Dr. Sanjay Kaul, a physician and statistician from UCLA, begins with this quotation:

Preconceived notions are the locks on the door to wisdom.
~ Merry Browne

Here is the relevant passage from Dr. Kaul’s editorial (italics added):

Sixth, it has been argued that the trial was unethical because there was no compelling clinical or preclinical evidence that chelation therapy has significant efficacy against atherosclerotic cardiovascular disease, and given that chelation therapy can cause harm, the risk was not minimal. A Bayesian analysis would not look kindly on the results because of the low prior probability of treatment effect (the so-called implausibility argument).6 This is an uncharitable (and unwarranted) interpretation of the data because previous systematic reviews concluded, “insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes among people with atherosclerotic cardiovascular disease.” It is axiomatic that absence of evidence of efficacy is not the same as evidence of the absence of efficacy.

From a Bayesian perspective, the strength of evidence is often summarized using a Bayes factor, which is a measure of how well 2 competing hypotheses (the null and the alternate) predict the data. The Bayes factor and the corresponding strength of evidence for the primary end point result in TACT overall, and diabetic cohorts are shown in Table 1. The p-value of 0.035 for TACT overall cohort translates into a Bayes factor of 0.108, which means the evidence supports the null hypothesis ≈1/9th as strongly as it does the alternative. This reduces the null probability from 50% pretrial (justified by suspension of one’s belief in treatment effect) to 10% post-trial. Although this does not represent strong evidence against the null, it does reduce the level of skepticism surrounding chelation therapy. In the diabetic cohort, the nominal p-value of 0.0002 translates into a Bayes factor of 0.002 (1/500), which reduces the extremely skeptical prior null probability of 95% to 4% post- trial, indicating very strong evidence against the null.

In concluding, Dr. Kaul states:

Finally, TACT highlights the double standard when it comes to accepting inconvenient results not aligned with our preconceived notions on so-called dubious quack cures such as chelation…

Closed minds?

Dr. Kaul’s reference “6” above is to a lengthy article that we published in 2008 titled “Why the NIH Trial to Assess Chelation Therapy Should Be Abandoned”. So, it seems, both Drs. Briggs and Kaul were chastising us for our biased, preconceived beliefs about so-called dubious quack cures. Our minds were, apparently, not open. Let’s examine this contention. (more…)

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

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Beware the Integrative Pharmacy

pharmacy window

Imagine a retail pharmacy where some of the medicines on the shelves have been replaced with similar-looking packages that contain no active ingredients at all. There is no easy way to distinguish between the real and the fake.

Another section of the store offers a number of remedies with fantastic claims, such as “boosting” the immune system, “detoxifying” the body, or “cleansing” you of microscopic Candida. They look sciencey, unless you realize that they treat imaginary medical conditions.

A corner of the store offers unpurified drugs supplied as tinctures and teas. The active ingredients aren’t known, and the batch-to-batch consistency of the product is unclear. The store will suggest products for you based on your symptoms.

Walk past the enormous wall of vitamins and other supplements and you’ll find a nutritionist who will tell you what products you should be taking. You’ll also find a weight loss section. From a science-based perspective, this shouldn’t even exist, given no product has been shown to offer any meaningful benefit. But there are dozens of products for sale.

At the back of the store you’ll finally find the pharmacist. A sign on the counter offers blood- and saliva-based tests for food “intolerance” and adrenal “fatigue”, claiming to test for medical conditions that actually don’t exist or lack an evidence base. The pharmacy also offers a large compounding practice, advertising what it calls “personalized” approaches to hormone replacement with “bioidentical” hormones.

Welcome to the “integrative” pharmacy.

You may not see all these features in your local drug store, but they’re coming: claims of a new “integrative” way to provide health care that is changing the face of retail pharmacy. Unfortunately, it’s harkening back to the era of patent medicines and snake oil. It’s not good for the pharmacists and the profession of pharmacy, and it’s even worse for patients. (more…)

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

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