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Archive for September, 2010

Chelation: Compounding Pharmacy’s Problems

Chelation is the provision of a substance to increase the body’s excretion of heavy metals. In poisoning situations (lead, aluminum, iron, etc.), chelation is medically necessary, objectively effective, and approved for use. But the same term has a completely different meaning in the alternative medicine universe, where proponents often believe heavy metal toxicity is the “one true cause” of disease, and chelation can undo microvascular inflammation, atherosclerosis, and even aging itself. From early days as an unproven treatment of coronary artery disease, its use has expanded to include autism, Alzheimer’s disease, cancer, and dozens of other diseases. Today, chelation is widely available. Regrettably, my own profession, pharmacy,  facilitates this pseudoscience by manufacturing and selling chelation products.

Provoked urine tests are a common entry point to chelation therapy. Patients are given a product to provoke heavy metal excretion. The urine is tested and the patient is informed that they’re “toxic” and require chelation. Unfortunately, these results are meaningless and provide no evidence that chelation is medically necessary. But that’s the justification used for advocating a treatment regimen that will be useless at best and fatal at worst. A recent Medical Letter review concluded:

Medical Letter consultants believe that the use of chelation therapy in non-standard protocols for unsubstantiated indications should be discouraged. The results of provoked urine testing are not an acceptable basis for such treatment.

Providing chelation to patients isn’t a straightforward matter. It’s typically an intravenous infusion (though there are some oral products). Unless you’re part of the dubious TACT trial, which has administration centres across the United States and Canada, there are few products commercially available. For example, edetate calcium disodium (EDTA) is approved for sale in the United States but not Canada. Edetate disodium (also called EDTA) is not approved for sale in either country. But these products are widely available: they’re manufactured by pharmacists in pharmacies.
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Posted in: Health Fraud, Medical Ethics, Pharmaceuticals

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When (Anti-Vax) Politics Intrudes

Over the last decade there has been a needed discussion about the relationship between politics and science. This has mostly been spawned by the perceived “Republican War on Science,” at the center of which is the global warming debate. In reality, both ends of the political spectrum (as evidenced, for example, by the Huffington Post) tend to trump science with ideology. That is the nature of politics. But at least the issue has been raised.

Briefly, defenders of science have pointed out that science should inform politics, not the other way around. Ideologues should not be allowed to put their thumb on the scale of science in order to get the result their ideology demands. Further, the optimal policy emerges from an honest assessment of the relevant science. Values still come into play for many issues, so science alone is not enough, but the science has to be right.

Within medicine this issue often involves the regulation of the standard of care and public health policy. An example of the former is the law passed last year is Connecticut that essentially exempts professionals who treat “chronic Lyme disease” from the standard of care – the department of health cannot act against their license for treating this controversial condition with unproven therapies.Rather than allowing experts to determine the standard of care, which is an ever moving target, this law locks into place a very controversial, and in my opinion dubious, practice.

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Posted in: Public Health, Science and Medicine, Vaccines

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Eric Pearl “Reconnects” with Hands-Off Healing

I first became aware of chiropractor Eric Pearl through the reprehensible movie The Living Matrix. Several months ago I reviewed that movie and described its segment featuring Pearl as follows:

A 5 year old with cerebral palsy was allegedly healed by “reconnective healing” by a chiropractor who is shown waving his hands a few inches away from the child’s body. Problem: There was no medical evaluation before and after to determine whether anything had objectively changed, and video of the child after treatment shows that his gait is not normal.

I have since learned that Pearl is far more than an eccentric oddball. He is a whole industry. He is teaching his “reconnective healing” methods to others worldwide through seminars in several languages, he engages in aggressive marketing, he offers practice-building advice to his many disciples, and he even foists his beliefs on groups of impressionable young children. I use the word disciples intentionally because there are strong religious overtones to this healing method. 

What is Reconnective Healing? 

“The Reconnection” is similar to therapeutic touch, but goes much farther. He does not need to physically touch patients because they can feel his touch without any contact. They close their eyes and he moves his hands around their bodies but several inches away. They feel a presence, see colors unknown on Earth, and often see angels (one particular angel is George, a multicolored parrot). Afterwards, they report miraculous healings of “cancers, AIDS-related diseases, epilepsy, chronic fatigue syndrome, multiple sclerosis, rheumatoid and osteoarthritis, birth disfigurements, cerebral palsy and other serious afflictions.” (more…)

Posted in: Energy Medicine

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The mammography wars heat up again

PRELUDE: THE PROBLEM WITH SCREENING

If there’s one aspect of science-based medicine (SBM) that makes it hard, particularly for practitioners, it’s SBM’s continual requirement that we adjust what we do based on new information from science and clinical trials. It’s not easy for patients, either. To lay people, SBM’s greatest strength, its continual improvement and evolution as new evidence becomes available, can appear to be inconsistency, and that seeming inconsistency is all too often an opening for quackery. Even when there isn’t an opening for quackery, it can cause a lot of confusion; some physicians are often resistant to changing their practice. It’s not for nothing that there’s an old joke in medical circles that no outdated medical practice completely dies until a new generation of physicians comes up through the ranks and the older physicians who believe in the practice either retire or die. There’s some truth in that. As I’ve said before, SBM is messy. In particular, the process of applying new science as the data become available to a problem that’s already as complicated as screening asymptomatic people for a disease in order to intervene earlier and, hopefully, save lives can be fraught with confusion and difficulties.

Certainly one of the most contentious issues in medicine over the last few years has been the issue of screening for various cancers. The main cancers that we most commonly subject populations to routine mass screening for include prostate, colon, cervical, and breast cancer. Because I’m a breast cancer surgeon, I most frequently have to deal with breast cancer screening, which means, in essence, screening with mammography. The reason is that mammography is inexpensive, well-tested, and, in general, very effective.

Or so we thought. Last week, yet another piece of evidence to muddle the picture was published in the New England Journal of Medicine (NEJM) and hit the news media in outlets such as the New York Times (Mammograms’ Value in Cancer Fight at Issue).
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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Short Attention Span SBM

The bar on this blog is set high. The entries are often complete, with no turn left unstoned. Yet, not every topic needs the full monty with every post. The blog has extensive evaluations on many topics, and new medical literature doesn’t require another complete analysis. Many new articles add incrementally to the literature and their conclusions need to be inserted into the conversation of this blog, like a car sliding into heavy traffic. My eldest son just received his driver’s license, and car metaphors are on my mind. As are crash metaphors and insurance metaphors.

So in response to this need, a need only recognized by me, I give you Short Attention Span SCAM. Occasionally I will summarize a few recent studies and their key points as they relate to prior posts at SBM.

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Posted in: Acupuncture, Herbs & Supplements, Science and Medicine, Vaccines

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Christiane Northrup: more bad medicine

A question popped up on facebook the other day about Dr. Christiane Northrup, an OB/GYN who has been a frequent guest on Oprah.  I hadn’t heard much about her for a while, but a foul taste still lingered from previous encounters with her work.  So I went over to her website to see what fare she’s currently dishing up.  It isn’t pretty. (Cached version).

This month’s news item is titled “Angst Over Not Vaccinating Children is Unwarranted.” Regular readers will be expecting a typical antivax screed, and they won’t be disappointed, but I’d like to highlight some of the propaganda techniques Northrup uses to advance her dangerous lies.

She begins her story with this:

In June, 2010 there was an outbreak of pertussis (whooping cough) in California that reporters were calling the worst epidemic in 50 years.

There are two problems with this opening sentence.  The outbreak is ongoing, and it’s not “reporters” who are calling it “the worst epidemic in 50 years.”  The California Department of Public Health reports that the state has seen the largest number of cases in the last 55 years.  Of course the state was much smaller 55 years ago, so for comparison they give us an incidence rate: 10.3 cases/100,000 in 2010, the highest rate in 48 years (when the rate was 10.9 cases/100,000).  So far in California, there have been 9 deaths.  All of the deaths were in babies eight of whom were unvaccinated and one of whom had been vaccinated only days before becoming ill, not early enough to develop immunity.
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Posted in: Science and Medicine

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CFLs, Dirty Electricity and Bad Science

Governments and environmental advocates are promoting compact fluorescent lightbulbs (CFLs) as a way of reducing electricity use, saving money, and reducing our carbon footprint. CFLs are not a perfect technology – when turned on they take a moment to fully brighten and they contain a small amount of mercury which requires special procedures for disposal. CFLs are likely also to be a transitional technology, as more energy efficient light sources (such as LEDs) are already coming onto the market.  But CFLs are a safe and energy efficient alternative to incandescent bulbs.

It seems, however, with any new technology comes a wave of internet fearmongering, and CFLs are now a prime target. YouTube videos are circulating claiming that CFLs cause headaches, mercury toxicity, a host of symptoms from electromagnetic sensitivity, and something called “type 3 diabetes.”  Let’s take a look at the claims and the science.

Mercury in CFLs

There is a small amount of mercury in each CFL, necessary for the function of the bulb, about 4mg on average, with some newer bulbs having as little as 1.4mg. There is no exposure to mercury from using CFLs, as long as they are not broken. Even if a bulb is broken the exposure to mercury is negligible, far less than eating a tuna fish sandwich. But still, there are recommended procedures for cleaning up and disposing of a broken bulb to further minimize exposure, such as not using a vacuum, and ventilating the area. These procedures represent the cautionary principle in action, but make it easy to fearmonger about the risks of the mercury in the bulb.

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Posted in: Public Health, Science and Medicine

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How not to consult your biostatistician before doing an experiment

A friend of mine at work sent this video to me in great amusement.

I just hope he wasn’t making a comment on my behavior when it comes to dealing with our biostatisticians. I have, of course, seen investigators approach biostatistians this late in the game. Not that I’ve ever flirted with this sort of behavior, of course. At least the researcher in the video above actually consulted the biostatistician before doing the experiment, rather than after doing an experiment with inadequate statistical power to answer the question asked. On the other hand, I guess it doesn’t matter if the researcher doesn’t listen, does it?

Posted in: Humor, Science and Medicine

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PTSD Breakthrough?: It’s Not Science Just Because Someone Says So

It infuriates me when someone misappropriates the word “science” to promote treatments that are not actually based on science. I have just read a book entitled The PTSD Breakthrough: The Revolutionary Science-Based Compass Reset Program by Dr. Frank Lawlis, a psychologist who is the chief content advisor for Dr Phil and The Doctors. There is very little science in the book and references are not provided. It amounts to an indiscriminate catalog of everything Dr. Lawlis can imagine that might help post-traumatic stress disorder (PTSD) patients.  (more…)

Posted in: Book & movie reviews, Neuroscience/Mental Health

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Clinical equipoise versus scientific rigor in cancer clinical trials

A critical aspect of both evidence-based medicine (EBM) and science-based medicine (SBM) is the randomized clinical trial. Ideally, particularly for conditions with a large subjective component in symptomatology, the trial should be randomized, double-blind, and placebo-controlled. As Kimball Atwood pointed out just last week, in EBM, scientific prior probability tends to be discounted while in SBM it is not, particularly for therapies that are wildly improbable strictly on the basis of basic science, but for both the randomized clinical trial remains, in essence, where the “rubber hits the road,” so to speak. Indeed, when the prior probability of a therapy working based on preclinical basic science investigations appears high, EBM and SBM should be (and are, for the most part) more or less indistinguishable.

The ethics of clinical trials, however, demand a characteristic known as clinical equipoise. Stated briefly, for purposes of clinical trials, clinical equipoise demands that at the time a clinical trial is being carried out there be a state of genuine scientific uncertainty in the medical community over which of the drugs or treatments being tested is more efficacious and safer. One reason (among many) why the Gonzalez trial was completely unethical was a lack of clinical equipose. (Lack of adequate informed consent was another.) Lack of clinical equipoise is also the reason why a prospective randomized, double-blind, placebo-controlled clinical trial testing an unvaccinated group versus a vaccinated control group to determine whether vaccines cause autism would be completely unethical. Such a trial would egregiously violate the principle of clinical equipoise because the unvaccinated group would be left unprotected against potentially life-threatening vaccine-preventable diseases, and that is completely unacceptable from an ethical perspective. Consequently, we have had to rely on on the accumulation of data from less rigorous trial designs to demonstrate that there is no correlation between vaccines and autism. Even so, the accumulated weight of such evidence is enough, and for some questions that is the best we can do because scientific rigor sometimes conflicts with human subjects research ethics. This is an extreme example of lack of clinical equipoise, but it illustrates the point. If we know (or have good scientific reason to suspect) that one treatment is better than another, it is unethical to randomize patients to the arm that receives what is, based on what is known at the time of the trial, likely to be an inferior treatment.

Sometimes, however, the question of whether clinical equipoise exists in a clinical trial is not so obvious as it is for trials proposed by cranks. This situation sometimes crops up in clinical trials for cancer. I was reminded of this issue by a front page story in the New York Times yesterday, New Drugs Stir Debate on Basic Rules of Clinical Trials. In it, reporter Amy Harmon uses a classic human interest story to highlight the issue of clinical equipoise in a clinical trial for a new drug for melanoma that shows great promise. In brief, it is the story of two cousins, one of whom is receiving the new “wonder drug” (whether it is truly a wonder drug or not remains to be seen) in a clinical trial and one of whom is receiving the current standard of care for stage IV melanoma, which, to put it bluntly, sucks in that it has very little effect in prolonging life:
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Posted in: Cancer, Clinical Trials, Medical Ethics

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