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Archive for August, 2010

Can it get any worse?: industrial bleach as cancer and HIV cure

On the heels of Scott Gavura’s superb post yesterday on dietary supplement regulation in the US and Canada, I bring you one of the most egregious and obscene product cases I have seen in 15 years of teaching on botanical and non-botanical products: Miracle Mineral Solution. Please accept my apologies in advance for not having a scholarly post for you today – this is just too unbelievable not to share with Science-Based Medicine readers.

On July 30, the FDA released this warning:


FDA NEWS RELEASE

For Immediate Release: July 30, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)
Product contains industrial strength bleach

The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.”  The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away.

MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.

The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.

The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible and to discard the product. Consumers and health care professionals should report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.


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Posted in: Cancer, Science and Medicine

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Supplement Regulation: Be Careful What You Wish For

A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls and changes to DSHEA, an international comparison may help focus the discussion around what a more science-based framework could look like.

Briefly, the DSHEA is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:

Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

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Posted in: Herbs & Supplements, Politics and Regulation, Science and Medicine

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Acupuncture Pseudoscience in the New England Journal of Medicine

Here is the conclusion quoted from a recent New England Journal of Medicine (NEJM) review article on acupuncture for back pain:

As noted above, the most recent wellpowered clinical trials of acupuncture for chronic low back pain showed that sham acupuncture was as effective as real acupuncture. The simplest explanation of such findings is that the specific therapeutic effects of acupuncture, if present, are small, whereas its clinically relevant benefits are mostly attributable to contextual and psychosocial factors, such as patients’ beliefs and expectations, attention from the acupuncturist, and highly focused, spatially directed attention on the part of the patient.

Translation – acupuncture does not work. Why, then, are the same authors in the same paper recommending that acupuncture be used for chronic low back pain? This is the insanity of the bizarro world of CAM (complementary and alternative medicine). Yesterday David covered the same article, which I had also covered on NeuroLogica, but we both thought this issue important enough to document our thoughts and objections on SBM.

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Posted in: Acupuncture, Science and Medicine

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Credulity about acupuncture infiltrates the New England Journal of Medicine

One of the things that disturbs me the most about where medicine is going is the infiltration of quackery into academic medicine. So prevalent is this unfortunate phenomenon that Doctor RW even coined a truly apt term for it: Quackademic medicine. In essence, pseudoscientific and even prescientific ideas are rapidly being “integrated” with science-based medicine, or, as I tend to view it, quackery is being “integrated” with scientific medicine, to the gradual erosion of scientific standards in medicine. No quackery is too quacky, it seems. Even homeopathy and naturopathy can seemingly find their way into academic medical centers.

Probably the most common form of pseudoscience to wend its way into what should be bastions of scientific medicine is acupuncture. Harvard, Stanford, Yale, M. D. Anderson, and many others, they’ve all fallen under the sway of the idea that somehow sticking thin little needles into points that bear no relationship to any known anatomic structure and that supposedly “unblock” the flow of some sort of “life energy” that can’t be detected by any means that science has. Most recently, as I described, studies that seek to “prove that acupuncture works” have found their way into high quality, high impact journals whose editors should know better but apparently can’t recognize that the evidence in the study doesn’t actually show what the authors claim it shows. Even so, there are some journals that I didn’t expect to see this sort of infiltration of quackademic medicine. Granted, I never expected it to show itself in one of the Nature journals, as it did in the study I just mentioned. I also never expected it to show up in that flagship of clinical journals, a journal that is one of the highest impact and most read medical journals that exists. I’m talking the New England Journal of Medicine, and, unfortunately, I’m also talking an unfortunately credulous article from Dr. Brian M. Berman, who is the founder of the Center for Integrative Medicine, University of Maryland School of Medicine and the holder of multiple NCCAM center grants, and other institutions, entitled Acupuncture for Chronic Low Back Pain.
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Posted in: Acupuncture, Medical Academia

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Home Birth Safety

More and more American women (1 in 200) are opting for home birth, and midwife-assisted home birth is common in other developed countries. How safe is it compared to birth in a hospital? A new study sheds some light on the subject. It was recently published in the American Journal of Obstetrics and Gynecology: Maternal and newborn outcomes in planned home birth vs planned hospital births: a metaanalysis, by Wax et al.

All the existing studies have flaws. It would be ideal to do a study where women were randomly assigned to home or hospital birth; that isn’t possible, so we have to fall back on studies that are possible. Just comparing home births to hospital births isn’t good enough, because high-risk births occur primarily in hospitals, and between 9% and 37% of planned home births end up with transfer to the hospital during labor and are converted into hospital births. Cohort studies comparing planned home with planned hospital births provide the best sources of data by intended delivery location. There have been several such studies, but the numbers were small and the results were inconclusive. This new study is a meta-analysis that combines the data into one large set for better understanding. (more…)

Posted in: Obstetrics & gynecology

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“Hard science” and medical school

One of the recurring themes of this blog, not surprisingly given its name, is the proper role of science in medicine. As Dr. Novella has made clear from the very beginning, we advocate science-based medicine (SBM), which is what evidence-based medicine (EBM) should be. SBM tries to overcome the shortcomings of EBM by taking into account all the evidence, both scientific and clinical, in deciding what therapies work, what therapies don’t work, and why. To recap, a major part of our thesis is that EBM, although a step forward over prior dogma-based medical models, ultimately falls short of making medicine as effective as it can be. As currently practiced, EBM appears to worship clinical trial evidence above all else and nearly completely ignores basic science considerations, relegating them to the lowest form of evidence, lower than even small case series. This blind spot has directly contributed to the infiltration of quackery into academic medicine and so-called EBM because in the cases of ridiculously improbable modalities like homeopathy and reiki, deficiencies in how clinical trials are conducted and analyzed can make it appear that these modalities might actually have efficacy.

Given this thesis, if there’s one aspect of medical education that I consider to be paramount, at least when it comes to understanding how to analyze and apply all the evidence, both basic science and clinical, it’s a firm grounding in the scientific method. Unfortunately, in medical school there is very little, if any, concentration on the scientific method. In fact, one thing that shocked me when I first entered what is one of the best medical schools in the U.S., the University of Michigan, was just how “practical” the science taught to us as students was. It was very much a “just the facts, ma’am,” sort of presentation, with little, if any, emphasis on how those scientific facts were discovered. Indeed, before I entered medical school, I had taken graduate level biochemistry courses for a whole year. This was some truly hard core stuff. Unfortunately, I couldn’t get out of taking medical school biochemistry my first year, but taking the course was illuminating. The contrast was marked in that in medical school there was very little in the way of mechanistic detail, but there was a whole lot of memorization. The same was true in nearly all the other classes we took in the first two years. True, for anatomy it’s pretty hard not to have to engage in a lot of rote memorization, but the same shouldn’t necessarily be true of physiology and pharmacology, for example. It was, though.

Over time, I came to realize that there was no easy answer to correcting this problem, because medical school is far more akin to a trade school than a science training school, and the question of how much science and in what form it should be taught are difficult questions that go to the heart of medical education and what it means to be a good physician. Clearly, I believe that, among other things, a good physician must use science-based practice, but how does medical education achieve that? That’s one reason why I’m both appalled and intrigued by a program at the Mt. Sinai School of Medicine for humanities majors to enter medical school without all the hard sciences. It’s a program that was written up in the New York Times last Wednesday in an article entitled Getting Into Med School Without Hard Sciences, and whose results were published in Medical Academia under the title Challenging Traditional Premedical Requirements as Predictors of Success in Medical School: The Mount Sinai School of Medicine Humanities and Medicine Program.

Let’s first take a look at how the NYT described the program:
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Posted in: Medical Academia, Science and Medicine

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