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Archive for Medical Ethics

Answering Our Critics, Part 2 of 2: What’s the Harm?

Last week I posted a list of 30 rebuttals to many of the recurrent criticisms that are made by people who don’t like what we say on SBM. I thought #30 deserved its own post; this is it. At the end, I’ve added a few items to the original list.

What’s the harm in people trying CAM? Science-based medicine has been criticized for being too rigid and intolerant. Why do we insist on randomized placebo-controlled trials to prove that a treatment is safe and effective? Isn’t it enough that patients tell us they feel better? Isn’t that what we all want, for our patients to feel better? Even if the treatment only works as a placebo, isn’t that a good thing? What’s the harm in that?

The albuterol/placebo study

I would argue that we don’t just want our patients to think they are better, we want them to actually be better. A study that illustrates that principle has been discussed on this blog before, here and here.

A group of patients using an effective albuterol asthma inhaler was compared to 2 placebo groups (a placebo inhaler group and a sham acupuncture group), and to a group that got no treatment at all. Patients reported the same relief of symptoms with each of the two placebo controls as with the albuterol inhaler; all three groups reported feeling significantly better than the no-treatment group. It could be argued that placebos are an effective treatment for the subjective symptoms of asthma. (more…)

Posted in: Medical Ethics, Science and Medicine

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When urgency to cure beats research ethics, bad things happen

Editor’s note: Just for your edification, here’s a “bonus” post. True, you might have seen this recently elsewhere, but it’s so appropriate for SBM that I couldn’t resist sharing it with those of you who might not read the other source where this was published recently. :-)

I’ve written a lot about Stanislaw Burzynski and what I consider to be his unethical use and abuse of clinical trials. Before that, I used to regularly write about Mark Geier and his unethical use and abuse of IRBs and clinical trials. Both doctors use their own IRBs stacked with their own cronies to rubberstamp scientifically and ethically dubious studies. Mark Geier got away with it for years. Stanislaw Burzynski got away with it for decades and, apparently, is still getting away with it to some extent. (His IRB is chaired by an old Baylor crony of his from the 1970s, and he has been cited for numerous problems with his IRBs.) I’d like to contrast how their unethical research, in which Mark Geier and his son David subjected autistic children to chemical castration with Lupron to decrease testosterone levels and allegedly make mercury easier to chelate (to them mercury was bound by testosterone, something that doesn’t happen under physiological conditions but requires organic solvents) and Stanislaw Burzynski administered an unproven cancer chemotherapy (antineoplastons) to hundreds of patients over the years and charged them for it, compares to a recent case in the news.

The case has been mentioned by PZ Myers. It happened that it involves the same sort of tumors that Stanislaw Burzynski claims to be able to cure, namely brain tumors. It happened at the University of California Davis (UC Davis) and involved two very prominent neurosurgeons there, a former head of the department Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot, who were found to have violated university’s faculty code of conduct with their experimental work. When you read this part of the story, you’ll shiver. At least, I did:
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Posted in: Cancer, Clinical Trials, Medical Ethics

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The Overuse of Antibiotics for Viral Infections in Children

“For every complex problem there is an answer that is clear, simple, and wrong.”

-H. L. Mencken

This approach is not endorsed by the American Academy of Pediatrics.

As I sit in an apartment full of unpacked boxes and grumpy children, only a few days removed from driving 1,600 miles to a 3rd floor walk-up and a better life just outside of Boston, I find the task of writing a post somewhat daunting. But I must admit that this new town is not without the potential for inspiring future musings. In fact, I find myself surrounded by irregular medicine of all shapes, sizes and dilutions.

Next door is a chiropractor who cures Tourette’s syndrome and, according to the pamphlet available outside the clinic entrance, only uses the in-house x-ray machine on select patients who truly need it. A few buildings down from me is an acupuncturist that treats athletic injuries with ear acupuncture and Kinesio-tape while liberally sprinkling references to his practice of “sports medicine” and “orthopedics” throughout the clinic’s promotional material. But at least I was reassured that acupuncture is completely harmless because it is a natural medicine. Finally, a block further down the road, completing my welcome committee of woo is a clinic that uses homeopathy to treat just about every real and fictional condition under the sun. I checked out their website and it’s a good thing that the walls are well insulated or my neighbors would have surely been forced to ignore the sound of my forehead pounding a wooden desk like a flagellant monk hoping for divine intervention.
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Posted in: Medical Ethics, Science and Medicine

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Meet Your Microbes: uBiome Offers New Service

We are not alone. Walt Whitman didn’t know how right he was when he said, “I contain multitudes.” The microbes on and in our bodies outnumber our own cells 10:1.  Perhaps that creeps you out. Perhaps that makes you curious to know just who all these billions of creatures are that are using your body for a home and a transportation device.

For just $89 you can learn what’s in your gut, nose, mouth, skin, genitals…or sample anything!

The offer comes from uBiome, a “citizen science startup” that has scientific goals somewhere down the line, but for the moment is happy to just provide a personal service, to sequence your microbiome and tell you how you compare to others. The current utility of this offering is questionable. It’s just not ready for prime time. (more…)

Posted in: Diagnostic tests & procedures, Medical Ethics

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Two Viewpoints

Most of what I read professionally is directed towards reality-based medicine. I spend my professional energies thinking about the application of reality to killing various and sundry microscopic pathogens.

The conceptual framework I use, and that used by others in medicine, does not concern itself with the application of the Supplements, Complementary and Alternative Medicines that occupy the attention of this blog. In acute care medicine SCAMs are of virtually no importance yet the approaches we need to take with patients and medicine are, with slight changes in emphasis, as applicable to SCAMs as real medicine. You need to remember, however, that the topic is not necessarily based in known reality.

Two viewpoints in JAMA caught my attention this month, both more thoughtful and reasoned than I am probably capable of. While focused on the application of reality-based medical practice, they apply to the topics of SBM as well. (more…)

Posted in: Clinical Trials, Medical Ethics, Science and Medicine

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Angelina Jolie, radical strategies for cancer prevention, and genetics denialism

I had been debating whether to blog about Angelina Jolie’s announcement last week in a New York Times editorial entitled My Medical Choice that she had undergone bilateral prophylactic mastectomy because she had been discovered to have a mutation in the BRCA1 gene that is associated with a very high risk of breast cancer. On the one hand, it is my area of expertise and was a big news story. On the other hand, it’s been nearly a week since she announced her decision, and the news story is no longer as topical as it was. Also, I’ve already written about it a couple of times on my not-so-super-secret other blog, making the division of blogging…problematic. So, if some of this is a bit repetitive to those who are also fans of my more—shall we say?—insolent persona, I apologize, but try to be patient. I will be doing more than just rehashing a couple of posts from last week (although there will unavoidably be at least a little of that), because there have been even more examples of reactions to Jolie’s announcement that provide what I like to consider “teachable moments.” I will start by asserting quite bluntly that in my medical opinion, from the information I have available, Angelina Jolie made a rational, science-based decision. How she went about the actual mechanics might have had some less than scientific glitches along the way (more about that later), but the basic decision to remove both of her breasts to prevent breast cancer associated with a BRCA1 mutation that she carried was quite reasonable and very defensible from a scientific standpoint.

One advantage of waiting nearly a week to write about this story is that it provided me with the opportunity to sit back and observe the reactions that Jolie’s decision provoked. One thing that I really didn’t expect (although in retrospect maybe I should have) is the pure denialism on display that genes have any effect whatsoever on cancer. I say “in retrospect I should have” because I’ve written at least a couple of times before about how quacks use and abuse the term “epigenetics” in the same way that they abuse the word “quantum” and how they seem to believe that wishing makes it so (through epigenetics, of course!) to the point where they believe that genetics is irrelevant to cancer. Indeed, they go far beyond that, asserting that, in essence, environment is all. From what I’ve been reading thus far, the second strongest strain of reaction to Jolie’s announcement (after revulsion at the “mutilation” of women that it represented to certain quacks) is pure denial that mutations in BRCA1 and BRCA2 genes portend such a high risk of ultimately developing breast cancer. This denial is often accompanied by conspiracy mongering about BRCA1 and BRCA2 mutations being a “conspiracy” on the part of the “cancer industry” and Myriad Genetics & Laboratories, the company that holds the patents on BRCA1 and BRCA2, to increase genetic testing and preventative mastectomies. Myriad happens to have a complete monopoly on BRCA1 and BRCA2 testing because of this patent and has been criticized for its high prices and stifling of competition. There is currently a case before the U.S. Supreme Court regarding whether human genes are patentable under the law. I’m not a big fan of Myriad, and I’ll tell you why later. (Not that it matters; I’m stuck with them for now.) My personal distaste for Myriad Genetics aside, this sort of conspiracy mongering is part and parcel of the quack approach to denying the significance of BRCA1 mutations.

This denial is usually coupled with confident blather that Angelina Jolie didn’t need to undergo “disfiguring” surgery to prevent BRCA1-associated breast cancer but instead could have achieved the same—or even better!—risk reduction if only she had used this magic herb or that miracle supplement and making certain “lifestyle” changes. It’s utter nonsense, of course, but it’s everywhere.

Before I get to the reactions to Jolie’s announcement, let’s first take a look at what she did, why, and the science behind it.
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Posted in: Basic Science, Cancer, Medical Ethics, Science and the Media

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Is thyroid replacement a performance-enhancing drug?

Has one physician uncovered the secret to Olympic Gold medals? And is that secret as simple as undiagnosed low thyroid function? That’s the question posed in a recent Wall Street Journal column entitled U.S. Track’s Unconventional Physician. Like the story that Steven Novella described yesterday, this narrative describes the medical practice of Dr. Jeffrey S. Brown, who sees thyroid illness where others see normal thyroid function. He has his critics, but his high-profile athlete patients have won a collective 15 Olympic gold medals. Case closed & Q.E.D.? Not quite. The WSJ actually does a pretty good job questioning the validity of Brown’s claims, which are far removed from the current medical consensus:

In athletic circles, Brown is a medical hero. He’s a paid medical consultant to Nike. The most renowned running coach at Nike, Alberto Salazar, calls Brown the best sports endocrinologist in the world. And athletes in growing numbers are coming to share Brown’s belief that heavy training can suppress the body’s production of the thyroid hormone, leaving them too exhausted to perform at peak. On the wall of the medical office of Jeffrey S. Brown is a photograph of Carl Lewis, the nine-time Olympic gold medalist. Lewis is one of several former or current patients of Brown’s who have climbed the Olympic podium, including Galen Rupp, who won a silver medal in the 10,000 meters at the London Olympics. “The patients I’ve treated have won 15 Olympic gold medals,” said Brown. Among endocrinologists, Brown stands almost alone in believing that endurance athletics can induce early onset of a hormonal imbalance called hypothyroidism, the condition with which he diagnosed Lewis and Rupp. Brown said he knows of no other endocrinologists treating athletes for hypothyroidism, a fatigue-causing condition that typically strikes women middle-aged or older. Several endocrinology leaders had never heard of hypothyroidism striking young athletes.

Now when I read “unconventional” and “stands alone” my skeptical alarm starts ringing. There is no shortage of debate about thyroid disease, ranging from the utter nonsense offered by “alternative health” practitioners to valid scientific discussions about the thresholds where normal function is considered abnormal and subject to treatment. Brown is an endocrinologist, however, and he’s treating elite athletes who are pushing their physical conditioning far beyond that seen by most medical doctors and almost all endocrinologists. So what’s the basis of the concern? The WSJ story goes on to discuss two different issues: What the proper threshold is for thyroid disease, and whether thyroid replacement is performance enhancing.  Let’s take each of these in turn. I’ve covered thyroid diseases and its related pseudoscience before, and a summary of the standard approach is necessary before we look at the some of the broader questions that have emerged from the story. All I know about these patients is what the WSJ is describing, so for the sake of brevity I’m going to focus on the types of cases that Dr. Brown appears to be identifying and ignore other causes of thyroid disease, which would require different treatment approaches.

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Posted in: Medical Ethics, Science and Medicine

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Enbrel for Stroke and Alzheimer’s

A recent article in the LA times tells of a husband’s quest to find a treatment for his wife’s Alzheimer’s disease. This is a narrative that journalists know and love—the brave patient or loved-one who won’t accept the nihilism of the medical establishment, who finds a maverick doctor willing to buck the system.

The article itself at least was not gushing, it tended toward a neutral tone, but such articles do tend to instill in the public a very counterproductive attitude toward science and medicine. I would have preferred an exposé of a dubious clinic exploiting desperate patients by peddling false hope. That is a narrative in which journalists rarely engage.

The story revolves around Dr. Edward Tobinick and his practice of perispinal etanercept (Enbrel) for a long and apparently growing list of conditions. Enbrel is an FDA-approved drug for the treatment of severe rheumatoid arthritis. It works by inhibiting tumor necrosis factor (TNF), which is a group of cytokines that are part of the immune system and cause cell death. Enbrel, therefore, can be a powerful anti-inflammatory drug. Tobinick is using Enbrel for many off-label indications, one of which is Alzheimer’s disease (the focus of the LA Times story).

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Posted in: Health Fraud, Medical Ethics, Politics and Regulation

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Undermining the regulation of stem cell therapies in Italy: A warning for the future?

Stem cells are magical.

At least, if you listen to what docs and “practitioners” who run stem cell clinics in various parts of the world, usually where regulation is lax and money from First World clientele is much sought after, that’s what you could easily come to believe. Unfortunately, it’s not just Third World countries in which “stem cell clinics” have proliferated. For instance, they are not nearly uncommon enough in Europe. The example that is most troubling right now is Italy, and the reason is that there is currently a law being considered that would greatly weaken the regulation of stem cell therapies, so much so that on Friday I saw something that’s fairly rare: a major scientific journal published a pointed editorial about this new law. Specifically EMBO Journal published a commentary by an international group of scientists warning about the path that the government of Italy is considering entitled Regulation of stem cell therapies under attack in Europe: for whom the bell tolls.

Stem cell quackery is a very popular form of quackery these days because, well, stem cells are so magical-seeming. You can now find stem cell treatments offered for autism (one of which, offered at a clinic in Costa Rica, I’ve discussed before and involves injecting “stem cells” into the cerebrospinal fluid of autistic children for a cool $15,000). Kent Heckenlively, the man who took his daughter to the aforementioned Costa Rica clinic for this treatment, is not alone in subjecting his autistic child to such unproven uses of stem cells. Just a couple of months ago, a broadcast journalist in the Philippines named Karen Davila took her autistic son to the Villa Medica Clinic in Germany, which offers variants of stem cell therapy. One is known as “fresh cell therapy” and involves harvesting cells from lamb fetuses and injecting them into the patient. The other is called fat stem cell repair therapy, which is claimed to involve harvesting fat from the patient’s abdomen or thigh and then isolating “stem cells” from them to be injected back into the patient’s body.
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Posted in: Basic Science, Clinical Trials, Legal, Medical Ethics, Politics and Regulation

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Rituximab for Chronic Fatigue Syndrome: Jumping the Gun

Now that the XMRV myth has been put to rest,  patients with Chronic Fatigue Syndrome (CFS) are no longer jumping the gun to demand anti-retroviral treatments. But they are jumping the gun in new ways, based on very preliminary data coming out of Norway.

A correspondent in Norway wrote to tell me patients from Norway with myalgic encephalitis/chronic fatigue syndrome (ME/CFS) are travelling to the US to have Dr. Andreas Kogelnik in San Francisco treat them with IV infusions of rituximab, apparently to no avail. A course of treatment costs over $6000, not to speak of travel and other expenses. (more…)

Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals

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