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Archive for Medical Ethics

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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Dr. Oz Doubles Down on Green Coffee Bean with a Made-for-TV Clinical Trial

“One of the most important discoveries I believe we’ve made that will help you burn fat – green coffee bean extract” – Dr. Oz, September 10, 2012, Episode “The Fat Burner that Works”

Dr. Mehmet Oz may be biggest purveyor of health pseudoscience on television today. How he came to earn this title is a bit baffling, if you look at his history. Oz is a bona fide heart surgeon,  (still operating 100 times per year), an academic, and a research scientist, with 300+ or 400+ (depending on the source) publications to his name. It’s an impressive CV, even before the television fame. He gained widespread recognition as the resident “health expert” on Oprah, and went on to launch his own show in 2009. Today “The Dr. Oz Show” is a worldwide hit, with distribution in 118 countries, a massive pulpit from which he offers daily health advice to over 3 million viewers in the USA alone. For proof of his power to motivate, just look at the “Transformation Nation Million Dollar You” program he launched in 2011, enrolling an amazing 1.25 million participants. Regrettably, what Oz chooses to do with this platform is often disappointing.  While he can offer some sensible, pragmatic health advice, his show’s content seems more focused on TV ratings than medical accuracy, and it’s a regular venue for questionable health advice (his own, or provided by guests) and poorly substantiated “quick fixes” for health issues. (And I won’t even touch Oz’s guests like psychic mediums.) One need only look at the number of times the term “miracle” is used on the show as a marker of the undeserved hyperbole. Just this week, Julia Belluz and Stephen J Hoffman, writing in Slate, itemized some of the dubious advice that Oz has offered on his show, with a reality check against what the scientific evidence says. It’s not pretty. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Medical Ethics

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Beyond Informed Consent: Shared Decision-Making

Happy New Year to all our readers! Today marks the completion of 5 years of SBM and the beginning of year 6. My contributions, at one a week, have now reached a total of 260. My first post on this blog, 5 years ago, was a review of an important book about science and alternative medicine, Snake Oil ScienceThis year I’d like to start with an important book about communicating medical science to patients, Critical Decisions,  by Peter A. Ubel, M.D.

I was wrong about informed consent. I thought informed consent was a matter of explaining the risks and benefits of treatments to patients so they could decide what they wanted to do.  That was naïve, simplistic, and misguided. Ubel’s book has radically changed my thinking about how doctors should interact with patients.

Paternalism in medicine is dead. Patient autonomy rules. We respect the right of patients to determine their own treatments, even if their choices seem unwise to us. Patients should do what they want. But there’s a problem: patients may not know what they really want. Emotions and unconscious and irrational forces influence their medical decisions. Preferences can change from one moment to the next, and they can shift with subtle changes in how treatments are described and how the issues are framed. Doctors need to develop a better understanding of what is going on in their patients’ minds, of how the way they present treatment options can inadvertently influence patients, and of how they can participate with patients in a process of shared decision-making. It’s possible to provide direction without paternalism. (more…)

Posted in: Book & movie reviews, Medical Ethics

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Storytelling in Medicine

We can’t stress often enough that anecdotes are not reliable evidence; but on the other hand, patient stories can serve a valuable purpose in medical education. Hearing how a disease affected an individual patient is more powerful than reading a list of symptoms in a textbook and is far more likely to fix the disease in the student’s memory. When I think of Parkinson’s disease, the first thing that comes to mind is my first patient with Parkinson’s and how he responded to levodopa; and the first thing that may come to many people’s minds is Michael J. Fox. Of course, we must realize that they may not be typical examples; but putting a face to a diagnosis serves as a memory aid and a hook to hang the rest of our knowledge on.

In his new book, The Power of Patient Stories: Learning Moments in Medicine, Paul F. Griner, MD relates more than 50 stories that distill the wisdom he has developed over a 58-year career of practicing medicine and teaching young doctors. He describes them as “stories that provided a learning moment for me.” It’s interesting to see how much medicine has changed over his professional lifetime and yet how cases from the 50s and 60s are still highly relevant. Ethical dilemmas and lessons about medical practice come alive under his pen. Each story is followed by incisive questions and exercises that engage the reader and challenge him to think about the issues. (more…)

Posted in: Book & movie reviews, History, Medical Academia, Medical Ethics

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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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