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The Dark Side of Medical Globalization

“You are not going to change what we do, you’re not going to change our determination to make these patients better. I see these patients, I know these patients, I value these patients, I’ve looked after them for years. I’ve seen them after the procedure, the vast majority are improved.”

The above quote could be a reference to just about any fringe medical treatment. It is partly an expression of faith in anecdotal experience over scientific evidence. It is partly the fallacy of justifying a treatment because it is needed – whereas the real question is whether or not the treatment works. It is an attempt to justify specific claims with compassion, as if the person quoted cares more for the health of their patients than those who might be skeptical of their claims. And it is an expression of stubbornness – I know the truth, so don’t confuse me with evidence and logic.

Is this person talking about acupuncture? Perhaps they run a stem cell clinic in China, India or somewhere outside the reach of regulation. Or maybe they are defending hyperbaric oxygen therapy for unproven indications, like autism. It could be anything, because this sentiment is the standard mantra of the dubious practitioner, practicing outside the bounds of science-based medicine.

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Posted in: Neuroscience/Mental Health, Science and Medicine

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Eating Placentas: Cannibalism, Recycling, or Health Food?

After giving birth, most mammals eat the afterbirth, the placenta. Most humans don’t. Several hypotheses have been suggested as to why placentophagy might have had evolutionary survival value, but are there any actual benefits for modern women? Placentophagy has been recommended for various reasons, from nutritional benefit to preventing postpartum depression to “honoring the placenta.” In other cultures, various rituals surround the placenta including burial and treating it as sacred or as another child with its own spirit. Eating the placenta is promoted by some modern New Age, holistic, and “natural-is-good” cultural beliefs.

Some women eat it raw, but many women have a yuck-factor objection to eating raw bloody tissue. It can be cooked: recipes are available for preparing it in various ways. For those who don’t like the idea of eating the tissue, placenta encapsulation services are available, putting placenta into a capsule that is more esthetically acceptable and that can even be frozen and saved for later use in menopause.

Does placentophagia benefit health? Does it constitute cannibalism? It it just a way to recycle nutrients? How can science inform our thinking about this practice? (more…)

Posted in: Nutrition, Obstetrics & gynecology

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Ethics in human experimentation in science-based medicine

Science-based medicine depends upon human experimentation. Scientists can do the most fantastic translational research in the world, starting with elegant hypotheses, tested through in vitro and biochemical experiments, after which they are tested in animals. They can understand disease mechanisms to the individual amino acid level in a protein or nucleotide in a DNA molecule. However, without human testing, they will never know if the end results of all that elegant science will actually do what it is intended to do and to make real human patients better. They will never know if the fruits of all that labor will actually cure disease. However, it is in human experimentation where the ethics of science most tend to clash with the mechanisms of science. We refer to “science-based medicine” (SBM) as “based” in science, but not science, largely because medicine can never be pure science. Science has resulted in amazing medical advances over the last century, but if there is one thing that we have learned it’s that, because clinical trials involve living, breathing, fellow human beings, what is the most scientifically rigorous trial design might not be the most ethical.

About a week ago, the AP reported that experiments and clinical trials that resemble the infamous Tuskegee syphilis study and the less well known, but recently revealed Guatemala syphilis experiment were far more common than we might like to admit. As I sat through talks about clinical trial results at the Society of Surgical Oncology meeting in San Antonio over the weekend, the revelations of the last week reminded me that the intersection between science and ethics in medicine can frequently be a very tough question indeed. In fact, in many of the discussions, questions of what could or could not be done based on ethics were frequently mentioned, such as whether it is ethically acceptable or possible to do certain followup trials to famous breast cancer clinical trials. Unfortunately, it was not so long ago that such questions were answered in ways that bring shame on the medical profession.
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Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Science and the Media

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Of SBM and EBM Redux. Part IV, Continued: More Cochrane and a little Bayes

OK, I admit that I pulled a fast one. I never finished the last post as promised, so here it is.

Cochrane Continued

In the last post I alluded to the 2006 Cochrane Laetrile review, the conclusion of which was:

This systematic review has clearly identified the need for randomised or controlled clinical trials assessing the effectiveness of Laetrile or amygdalin for cancer treatment.

I’d previously asserted that this conclusion “stand[s] the rationale for RCTs on its head,” because a rigorous, disconfirming case series had long ago put the matter to rest. Later I reported that Edzard Ernst, one of the Cochrane authors, had changed his mind, writing, “Would I argue for more Laetrile studies? NO.” That in itself is a reason for optimism, but Dr. Ernst is such an exception among “CAM” researchers that it almost seemed not to count.

Until recently, however, I’d only seen the abstract of the Cochrane Laetrile review. Now I’ve read the entire review, and there’s a very pleasant surprise in it (Professor Simon, take notice). In a section labeled “Feedback” is this letter from another Cochrane reviewer, which was apparently added in August of 2006, well before I voiced my own objections:

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Posted in: Clinical Trials, Homeopathy, Medical Academia, Science and Medicine

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Topical NSAIDs

I have a mental basket of drugs that I suspect may be placebos. In that basket were the topical versions of non-steroidal anti-inflammatory drugs (NSAIDs). When the first products were commercially marketed over a decade ago, I found the clinical evidence unconvincing, and I suspected that the modestly positive effects were probably due to simply rubbing the affected area, or possibly due to the effects of the cream or vehicle itself. Frankly, I didn’t think these products worked. So when I recently noticed a topical NSAID appear for sale as an over-the-counter treatment for muscle aches and pains (seemingly only in Canada, for now), I was confident it would make a good case study in bad science.

It’s not that I’m partial to the oral NSAIDs. Yes, they’re among the most versatile, and probably most well-loved drugs in our modern medicine cabinet. They offer good pain control, reduce inflammation and can eliminate fever. We start using it in our sick and feverish infants, through childhood and adulthood for the aches and pains of modern life, and into our later years for the treatment of degenerative disease like osteoarthritis, which affects pretty much everyone as we age. An astonishing 17 million Americans use NSAIDs on a daily basis, and this number is expected to grow as the population ages. In the running groups I frequent, ibuprofen has the affectionate nickname “Vitamin I”, where it’s perceived as an essential ingredient for dealing with the consequences of training.

But NSAIDs have a long list of side effects. Not only do they cause stomach ulcers and bleeding by damaging the gastrointestinal mucosa, there are heart risks, too. It was the arrival (and departure) of the drugs Bextra and Vioxx that led to documentation of the potential for cardiovascular toxicity. And now there’s data to suggest that these effects are not limited to the “COX-2” drugs – almost all NSAIDs, including the old standbys we have used for years, seem capable of raising the risks of heart attacks and strokes.

So despite my initial skepticism, I took another look at the topical NSAIDs. The data were not what I expected.

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Posted in: Pharmaceuticals, Science and Medicine

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Placebo Effect for Pain

It has long been recognized that there are substantial multifactorial placebo effects that create real and illusory improvements in response to even an inactive treatment. There is a tendency, however (especially in popular discussion), to oversimplify placebo effects – to treat them as one mind-over-matter effect for all outcomes. Meanwhile researchers are elucidating the many mechanisms that go into measured placebo effects, and the differing magnitude of placebo effects for different outcomes.

For example, placebo effects for pain appear to be maximal, while placebo effects for outcomes like cancer survival appear to be minimal.

A recent study sheds additional light on the expectation placebo effect for pain. The effect is, not surprisingly, substantial. However it does not extrapolate to placebo effects for outcomes other than pain, and the results of this very study give some indication why. From the abstract:

The effect of a fixed concentration of the μ-opioid agonist remifentanil on constant heat pain was assessed under three experimental conditions using a within-subject design: with no expectation of analgesia, with expectancy of a positive analgesic effect, and with negative expectancy of analgesia (that is, expectation of hyperalgesia or exacerbation of pain).

What they found was that the positive expectation group reported twice the analgesic effect as the no expectation group, and the negative expectation group reported no analgesic effect. This is a dramatic effect, but not surprising.

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Posted in: Neuroscience/Mental Health, Pharmaceuticals

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Questioning the Annual Pelvic Exam

A new article in the Journal of Women’s Health by Westhoff, Jones, and Guiahi asks “Do New Guidelines and Technology Make the Routine Pelvic Examination Obsolete?”

The pelvic exam consists of two main components: the insertion of a speculum to visualize the cervix and the bimanual exam where the practitioner inserts two fingers into the vagina and puts the other hand on the abdomen to palpate the uterus and ovaries. The rationales for a pelvic exam in asymptomatic women boil down to these:

  • Screening for Chlamydia and gonorrhea
  • Evaluation before prescribing hormonal contraceptives
  • Screening for cervical cancer
  • Early detection of ovarian cancer

None of these are supported by the evidence. Eliminating bimanual exams and limiting speculum exams in asymptomatic patients would reduce costs without reducing health benefits, allowing for better use of resources for services of proven benefit. Pelvic exams are necessary only for symptomatic patients and for follow-up of known abnormalities. (more…)

Posted in: Obstetrics & gynecology

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Skepticism versus nihilism about cancer and science-based medicine

Last Friday, Mark Crislip posted an excellent deconstruction of a very disappointing article that appeared in the most recent issue of Skeptical Inquirer, the flagship publication of the Committee for Skeptical Inquiry (CSI). I say “disappointing,” because I was disappointed to see SI (Skeptical Inquirer, not Sports Illustrated) publish such a biased, poorly thought out article, apparently for the sake of controversy. I’m a subscriber myself, and in general enjoy reading the magazine, although of late I must admit that I don’t always read each issue cover to cover the way I used to do. Between work, grant writing, blogging, and other activities, my outside reading, even of publications I like, has declined. Perhaps SI will soon find itself off my reading list. Be that as it may, I couldn’t miss the article that so irritated Mark, because it irritated me as well. There it was, emblazoned prominently on the cover of the March/April 2011 issue: Seven Deadly Medical Hypotheses. I flipped through the issue to the article to find out that this little gem was written by someone named Reynold Spector, MD. A tinge of familiarity going through my brain, I tried to think where I had heard that name before.

And then I remembered.

Dr. Spector, it turns out, first got on my nerves about a year ago, when he wrote an article for the January/February 2010 issue of SI entitled The War on Cancer: A Progress Report for Skeptics. I remember at that time being irritated by the article and wanting to pen a discussion of the points raised but don’t recall why I never actually did. It was probably a combination of the fact that SI doesn’t publish its articles online until some months have passed after the paper version has been released and perhaps my laziness about having to manually transcribe with my own fingers any passages of text that I might want to cite. By the time the article was available online, I forgot about it and never came back to it–until now. I should therefore, right here, right now, publicly thank Mark (and, of course, Dr. Spector) for providing me the opportunity to revisit that article in the context of piling on, so to speak, Dr. Spector’s most recent article. After all, Deadly Hypothesis Seven (as Dr. Spector so cheesily put it) is:

From a cancer patient population and public health perspective, cancer chemotherapy (chemo) has been a major medical advance.

Dr. Spector then takes this opportunity to cite copiously from his 2010 article, sprinkling “(Spector, 2010)” throughout the text like powdered sugar on a cupcake. There’s the opening I needed to justify revisiting an article that’s more than a year old! And what fantastic timing, too, hot on the heals of my post from a couple of weeks ago entitled Why haven’t we cured cancer yet?
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Posted in: Cancer, Science and Medicine, Science and the Media

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