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Don’t just stand there, do nothing! The difference between science-based medicine and quackery

Tree of Life - the first-known sketch by Charles Darwin of an evolutionary tree describing the relationships among groups of organisms (Cambridge University Library).

Tree of Life – the first-known sketch by Charles Darwin of an evolutionary tree describing the relationships among groups of organisms (Cambridge University Library).

The Merriam-Webster Dictionary defines science as:

Knowledge about or study of the natural world based on facts learned through experiments and observation.

And:

Knowledge as distinguished from ignorance or misunderstanding.

While this should distinguish science from pseudoscience, those who practice the latter often lay claim to the same definition. But one of the major differences between science and pseudoscience is that science advances through constant rejection and revision of prior models and hypotheses as new evidence is produced; it evolves. This is the antithesis of pseudoscience. At the heart of pseudoscience-based medicine (PBM) is dogma and belief. It clings to its preconceptions and never changes in order to improve. It thrives on the intransigence of its belief system, and rejects threats to its dogma. Despite the constant claims by peddlers of pseudoscience that SBM practitioners are closed-minded, we know that, in fact, PBM is the ultimate in closed-minded belief. Of course, those of us who claim to practice SBM aren’t always quick to adopt new evidence. We sometimes continue practices that may once have been the standard of care but are no longer supported by the best available evidence, or perhaps may even be contradicted by the latest evidence. Often this is a byproduct of habituated practice and a failure to keep current with the literature. While this is certainly a failure of modern medicine, it is not an inevitable outcome. It is not emblematic of the practice of medicine, as it is with PBM. When medicine is science-based, it strives for continual improvement based on modifications around emerging evidence. (more…)

Posted in: Critical Thinking, Medical Ethics, Public Health, Science and Medicine

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Cancer Centers and Advertising Practices

Video advertisement for the Cancer Treatment Centers of America, hosted on their website. Note at the bottom the statement “No case is typical. You should not expect to experience these results” (click to embiggen).

You have probably seen the TV commercials or other ads for Cancer Treatment Centers of America. They make it sound like “the place to go” if you have cancer. They claim to be “different,” to combine the best cancer technologies with natural therapies in a humane, patient-centered approach that helps you fight the disease and maintain your quality of life. They offer a kinder, gentler, more effective oncology. Those ads are misleading.

Dr. Gorski has written about the practices of Cancer Treatment Centers of America here and here. He has shown how they “integrate” real medicine with nonsense like homeopathy and how they misrepresent components of science-based medicine like exercise and diet, re-branding them as “alternative.”

A recent study by Vater et al. published in the Annals of Internal Medicine asked “What are cancer centers advertising to the public?” They found that the ads appealed to emotion, failed to provide important information, falsely portrayed testimonials as typical, and should be viewed as critically as any other advertising. (more…)

Posted in: Cancer, Medical Ethics, Science and the Media

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The Wild West: Tales of a Naturopathic Ethical Review Board

Two recent SBM posts have used the “Wild West” metaphor for poor health care regulation. Arizona may be the wildest: a worst-case scenario of a state licensing pseudoscience as medicine, under the cover of so-called naturopathy “research.” (Photo courtesy of the Orange County Archives, some rights reserved).

Right before I left the naturopathic profession, an Arizona naturopath told me that “all NDs are doing something borderline illegal.” Alarmed, I began looking around me.

Arizona naturopathic cancer clinics promote illegal substances, advertise results that are too good to be true, and use compounds that have yet to be proven effective in humans. Many clinics focus on intravenous therapies using ozone, hydrogen peroxide, sodium bicarbonate, vitamin C, and blood UV irradiation; some drugs and herbal preparations for injection are claimed to be imported from Europe.

In Arizona, current regulation enables naturopaths to craft hollow research projects under the cover of a private naturopathic institutional review board (an IRB, also often called an ethical review board). This allows them to legitimize experimentation on patients in private clinics and expand the naturopathic scope of practice in the name of so-called research. The IRB appears to influence the state’s naturopathic board, which seems reluctant to do its job properly.

Naturopathic regulation in Arizona may be the worst-case scenario of any state licensing pseudoscience as medicine. The ramifications are grave. Patients, especially those with cancer or other serious conditions, are easily duped and can be severely harmed by medical practitioners who seem kind, charismatic, and confident, but are actually inept and experimenting without the oversight of an ethical review board.

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Posted in: Health Fraud, Legal, Medical Ethics, Naturopathy, Science and Medicine

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Pseudoscience North: What’s happening to the University of Toronto?

Trojan Rabbit

 

Today’s post is a reluctant challenge. I’m nominating my own alma mater, the University of Toronto, as the new pseudoscience leader among large universities – not just in Canada, but all of North America. If you can identify a large university promoting or embracing more scientifically questionable activities, I’ll happily buy you a coffee. Yes, it’s personal to me, as I have two degrees from U of T. But I’m more concerned about the precedent. If Canada’s largest university is making decisions that appear to lack a careful consideration of the scientific evidence, then what does that suggest about the scientific standards for universities in Canada? (more…)

Posted in: Chiropractic, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Traditional Chinese Medicine, Vaccines

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Significant Ruling Against Conversion Therapy

gay-flag

The standard features of quackery are all there. Proponents of this particular therapy claim that a normal condition is a disease. They make false claims about the cause of this disease. They then charge thousands of dollars for their fake treatment to cure the fake disease, and claim success rates that are not backed by any statistics.

In this case the fake disease is homosexuality, for which there is now a solid consensus that it is a normal variation of human sexuality. The fake treatment is conversion therapy. Recently a New Jersey judge ruled that conversion therapists cannot claim that homosexuality is a disease or disorder. The Southern Poverty Law Center reports:

Superior Court Judge Peter F. Barsio Jr. found that it “is a misrepresentation in violation of [New Jersey’s Consumer Fraud Act], in advertising or selling conversion therapy services, to describe homosexuality, not as being a normal variation of human sexuality, but as being a mental illness, disease, disorder, or equivalent thereof.”

Further:

The judge also ruled that [New Jersey conversion therapy provider Jews Offering New Alternatives for Healing (JONAH)] is in violation of the Consumer Fraud Act if it offers specific success statistics for its services when “client outcomes are not tracked and no records of client outcomes are maintained” because “there is no factual basis for calculating such statistics.”

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Posted in: Legal, Medical Ethics

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Facing Decline and Death

Gawande book

Note: Atul Gawande and his book will be featured on a Frontline episode airing on PBS tonight.

We’re all going to die. (There’s nothing like starting on a positive note! :-) ) We’re all going to die, and if we are fortunate enough to survive long enough to become old, we’re all going to experience a decline of one sort or another before we die: reduced hearing and vision, less strength, poorer memory, etc. As a society, and as a medical profession, we have been reluctant to confront those issues head on. Dr. Atul Gawande faces them unflinchingly in his thought-provoking new book Being Mortal: Medicine and What Matters in the End.

In a simpler time, there were fewer old people; they were respected for their knowledge and were cared for by their families who supplied their increasing needs as age made them more dependent on others; they died at home surrounded by supportive loved ones. Today we warehouse our elders in nursing homes, where they are denied the independence of even making simple everyday choices like when to get up and when to eat. We consign them to a regimented, less enjoyable, less meaningful life; and they frequently die alone in hospitals, connected to tubes and machines.

Doctors are not always good at making it clear to terminally ill patients that they are going to die soon. They are not always good at discussing end-of-life issues and securing advance directives. They often treat end-of-life diseases so aggressively that they end up causing more suffering or even shortening lives. (more…)

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

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Selling complementary and alternative medicine: An business ethics perspective

I joined Professor Chris MacDonald at Ryerson University earlier this week to participate in Ryerson’s business ethics speaker series. The topic was CAM:

Is it ethical to market complementary and alternative medicines? Complementary and alternative medicines (CAM) are medical products and services outside the mainstream of medical practice. But they are not just medicines (or supposed medicines) offered and provided for the prevention and treatment of illness. They are also products and services – things offered for sale in the marketplace. Most discussion of the ethics of CAM has focused on bioethical issues – issues having to do with therapeutic value, and the relationship between patients and those purveyors of CAM. This presentation — by a philosopher and a pharmacist — aims instead to consider CAM from the perspective of commercial ethics. That is, we consider the ethics not of prescribing or administering CAM (activities most closely associated with health professionals) but the ethics of selling CAM.

If it’s not embedded above, you can watch the whole presentation on CAM and business ethics with this link.

It was great to see so many public members attend and participate. There was an extended Q&A afterwards, with some very thoughtful audience questions. Outside of blogs like this, and those of CAM critics like Edzard Ernst, the practical ethics of CAM provision are rarely discussed.  Watch for more on this topic in the future.

 

Posted in: Announcements, Homeopathy, Medical Ethics, Politics and Regulation

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Stem cell clinics and unapproved, for-profit human experimentation

Editor’s note: I met Dr. Paul Knoepfler online in the wake of my two posts on Gordie Howe and his stem cell treatment for stroke. I was impressed by his posts on the topic and what I saw at his own blog. Given that he’s a stem cell researcher, I wanted him to write a post on stem cell clinics like the one that treated Gordie Howe, and, I’m happy to say, he accepted my invitation and agreed to write this post. I hope to persuade him to write more for us in the future, even though he has his own blog.


When I started blogging in 2010 the stem cell arena was a very different place.

Back then the hot topic was the battle over the legality of federal funding of embryonic stem cell research. That battle is over, or at least in hibernation, with a 2013 federal court ruling allowing such funding to continue. The stem cell debate of today, which in its own way is just as fierce as the old one, is focused on how best to regulate the clinical translation and commercialization of innovative stem cell technologies.

The stakes in this new stem cell battle on the regulatory front are very high both for the stem cell field and for patients. Too little regulation could lead to harm to patients and damage to the stem cell field at a crucial juncture in its history, while too much regulation could stifle stem cell and regenerative medicine innovations.

Stem cell clinics should be better-regulated than a Starbucks

Stem cell clinics should be better-regulated than a Starbucks

The goal of stem cell advocates, including myself, is to find a regulatory sweet spot where science-based, innovative stem cell medicine can advance expeditiously. On the other side we have largely physicians and lawyers along with some patients arguing for drastically-reduced regulation and acceleration of for-profit stem cell interventions to patients, even without concrete data supporting safety or efficacy.

The latter group is a key part of a rapidly-proliferating stem cell clinic industry in the US. It consists of for-profit stem cell clinics that collectively have already conducted stem cell transplants on potentially thousands of patients without federal regulatory approval. These clinics have in effect thrown down the gauntlet to the US Food and Drug Administration (FDA) with their use of non-FDA approved stem cell products on patients. (more…)

Posted in: Legal, Medical Ethics, Politics and Regulation, Science and the Media

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Stem cells versus Gordie Howe’s stroke, part 2

Gordie-Howe

Another Christmas has come and gone, surprisingly fast, as always. I had thought that it might make a good “last of 2014″ post—well, last of 2014 for me, anyway; Harriet and Steve, at least, will be posting before 2014 ends—to do an end of year list of the best and worst of the year. Unfortunately, there remains a pressing issue that doesn’t permit that, some unfinished business, if you will. I’m referring to a story I commented on last week, specifically the credulously-reported story of how 86-year-old hockey legend Gordie Howe is doing a lot better after having undergone an experimental stem cell therapy for his recent stroke. As you might recall at the time, I saw a lot of holes in the story. It turns out that over the last week there have been developments that allow me to fill in some of those holes. Unfortunately, other holes still remain.

First, a brief recap is in order (You can click here for a more detailed timeline). Gordie Howe suffered a massive stroke on October 26, leaving him hemiplegic and with serious speech impairment. Since then, judging from various media reports, he has been slowly improving, although not without significant setbacks. We also know that Howe suffers from significant dementia. Out of the blue, a press release issued on December 19 by the Howe family announced that on December 8 and 9, Gordie Howe “underwent a two-day, non-surgical treatment at Novastem’s medical facility. The treatment included neural stem cells injected into the spinal canal on Day 1 and mesenchymal stem cells by intravenous infusion on Day 2.” His response was described as “truly miraculous,” although, as I pointed out in my post, it’s not clear exactly what “miraculous” meant, given conflicting contemporaneous news accounts before the Howe family press release, particularly his hospitalization from December 1 to 3 for a suspected stroke that turned out to be dehydration.

I noted a number of problems with the story, the first of which is that Howe was clearly not eligible for the clinical trial offered by Stemedica, a company in San Diego that manufactured the stem cells used. Another glaring issue was my inability to locate any description of an actual clinical trial for stroke offered by Novastem. I could find no such trial listed in ClinicalTrials.gov, and you, our intrepid readers, searched the registry maintained by the Mexican Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) and were not able to find any registered clinical trials for stroke being carried out by Clínica Santa Clarita, the clinic Novastem operates. What you, our intrepid readers, did find were trials of stem cells for:

I did the search again over the weekend, and there were no further trials that I could find.
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Posted in: Clinical Trials, Medical Ethics, Science and the Media

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Stem cells versus Gordie Howe’s stroke

GordieHowe1

Note: There is now a major update to this story published here, which explains a lot of the questions remaining in this blog post.

Seven years ago I returned to Michigan, where I was born and spent the first quarter century of my life, after an absence of more than 20 years. In the interim, I had done my surgical residency and earned my PhD in Cleveland, a surgical oncology fellowship in Chicago, and worked in New Jersey at my first academic job for eight and a half years. Then I was lured back with a job in Detroit. One of the odd things about this return after such a long absence was the culture shock, how much I had forgotten about the Detroit area. One of those things that I had forgotten is just how crazy about hockey Michigan, in particular Detroit (meaning the Detroit metropolitan area), is. Detroiters love their Red Wings—love them. Hockey is ingrained in the suburban culture from a very young age, so much so that many Canadians would feel right at home here. Memories of trying and failing to be halfway decent at street hockey and of not being anywhere good enough a skater even to try real hockey as a teen came flooding back to me. (It didn’t help that back then I was approaching six feet tall and weighed only 135 lbs.; “beanpole” didn’t even begin to describe me back then.) In fact, the “cultural center” of the town where I live consists of—I kid you not—a hockey rink and some classrooms that are used for various community functions. No, really, it’s named the city’s Cultural Center.

So it should be no surprise, given how much Detroiters love hockey in general and their Red Wings in particular that it was big news here in late October when Red Wing legend Gordie Howe at age 86 suffered a debilitating stroke that paralyzed the right side of his body, a condition known as hemiplegia. Understandably, there was an outpouring of good wishes for recovery, coupled with retrospectives of Howe’s stellar hockey career. Indeed, I remember that Howe’s condition sounded bad enough from the tenor of the news reports at the time that it seemed likely that he would not survive. But survive he did, and is apparently recovering slowly, with occasional setbacks, such as a recent hospitalization in early December for a suspected “mini-stroke” that turned out to be dehydration and several much smaller strokes before that. The most recent press report I saw before the announcements I’m going to discuss described Howe as on the upswing again.

Then, on Friday, I saw headlines all over the place that were basically similar to this Detroit Free Press headline, “Gordie Howe underwent stem cell clinical trial in Mexico.” The story consisted largely of a press release from Howe’s family that read:
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Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Science and the Media

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