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Archive for July, 2012

Therapy or Injury? Your Tax Dollars at Work.

 

 
The U.S. Army Medical Command recently announced a job opening  in the Interdisciplinary Pain Management Center at the San Antonio Military Medical Center at Fort Sam Houston, Texas. Two GS-12 positions were advertised for acupuncturists at a salary of $68,809 to $89,450. As a licensed acupuncturist, a candidate would be expected to

offer a full array of the most current and emerging evidenced based approaches in integrative medicine for patients with acute and chronic pain who have not responded well to conventional treatment modalities.

This is wrong on more levels than one. After giving lip service to the politically correct term “evidence based” they proceed to include clearly non-evidence-based modalities in the job description. Rigorous scientists do not classify acupuncture itself as evidence-based, since the evidence is compatible with the hypothesis that it is no more than an elaborate system to provide placebo and other nonspecific effects. And the described duties of the position make it even worse.   (more…)

Posted in: Acupuncture

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The perils and pitfalls of “patient-driven” clinical research

Dying of cancer can be a horrible way to go, but as a cancer specialist I sometimes forget that there are diseases that are equally, if not more, horrible. One that always comes to mind is amyotropic lateral sclerosis (ALS), more commonly known as Lou Gehrig’s disease. It is a motor neuron disease whose clinical course is characterized by progressive weakness, muscle atrophy and spasticity, with ultimate progression to respiratory muscles leading to difficulty breathing and speaking (dysarthria) and to the muscles controlling swallowing. The rate of clinical course is variable, often beginning with muscle twitching in an arm or a leg or slurring of speech. Ultimately, however, ALS progresses to the loss of ability to move, speak, eat, or breathe. The most common cause of death is from respiratory failure, usually within three to five years after diagnosis, although there is the occasional outlier with a less malignant form of the disease with a slower course of progression who can live a long time, such as Steven Hawking.

In other words, ALS is a lot like cancer in some ways. It is a progressive, fatal disease that usually kills within a few years at most. On the other hand, it is different from cancer in that, at least for many cancers we actually do have effective treatments that prolong life, in some cases indefinitely. In contrast the most effective treatment we currently have for ALS is a drug (riluzole) that is not particularly effective—it prolongs life by months—and can be best described as better than nothing, but not by a whole lot. So it is not surprising that ALS patients, like cancer patients, become desperate and willing to try anything. This is completely understandable, but sometimes this desperation leads to activities that are far more likely to do harm than good. I was reminded of this when I came across a post in the antivaccine propaganda blog, Age of Autism, referring to an article in The Scientist entitled Medical Mavericks. The fortuitous posting of this story, which was apparently designed to try to show that it’s not as crazy as critics have said to be treating autistic children with “Miracle Mineral Solution” (MMS) (which is a bleach) given that the introduction explicitly mentioned Kerri Rivera and the patient described in the article used sodium chlorite to treat his ALS, provided me the opening to discuss a group whose existence and advocacy brings up a complex tangle of issues that boil down to questions of how far patient autonomy should be allowed to go. I’m referring to a company, PatientsLikeMe, which describes itself thusly:
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Posted in: Cancer, Clinical Trials, Neuroscience/Mental Health

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Journal Club

There is a tradition in medical training called Journal Club. The first rule of Journal Club is you do not talk about Journal Club. In Journal Club, at least in the iterations in which I have participated, one article is selected by an attending, everyone reads it, then the strengths, weakness and applicability are discussed by the group. Usually a top notch, ground breaking article was the focus, one that had high potential clinical impact. But since they were good articles in good journals, there was not a lot to learn about in reguards to critical thinking. While the attending would put the article in context and maybe discuss some rudimentary statistics, there was little that was discussed about the quality of the study. The main take home from every study was to question the applicability of the results to populations that were not old, white males, since it seemed all the ground breaking studies back in the day were a VA Cooperative study of one sort or another.

As I remember it, there was not really a conceptual frame work with which to evaluate studies. Bayes theorem, and its application to clinical medicine was never explicitly discussed outside of testing, where you have to consider the prior plausibility of the patient having a disease before you can decide if the test results is a true positive or not. In Portland, Oregon, the chance that a Lyme serology is a false positive is much greater than a test done in Portland, Maine. Generally speaking in the information overload state that is the practice of medicine, clinical trials are generally taken at face value and tests are considered infallible. Which is a shame, as I wonder how much suboptimal medicine is inflicted on patients by not considering prior plausibility and how accurate a given test is in either ruling in or out a disease. There seems to be a whole industry built around treating patients with no risks for Lyme but have positive tests of doubtful provenance. We never discussed the prior plausibility and its effect on the outcomes of a studied treatment. (more…)

Posted in: Clinical Trials, Science and Medicine

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NCCAM manipulates spinal manipulation

“Complementary and alternative medicine,” as pediatrician and fellow blogger John Snyder aptly stated in a recent journal article on CAM and children,

is a term used to describe a disparate, poorly defined set of practices and treatment modalities presumed to be distinct from so-called ‘conventional medicine’.

As we have discussed here at Science-Based Medicine, this amorphous concept facilitates a convenient fluidity in delineating the parameters of CAM. Without a clear definition, CAM (and integrative medicine) proponents are able to rebrand plausible and evidence-based practices such as diet, exercise and relaxation as CAM, a tactic we at SBM call “bait and switch.” This results in inflation in the figures of CAM use (important because CAM is all about popularity) and claims that CAM “works.”

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Posted in: Chiropractic, Politics and Regulation

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Olympic Pseudoscience

The Summer Olympics are coming up, which means that, in addition to world-class athletic performance, the public will be exposed to a variety of sports-related pseudoscience. This is not unique to the Olympics, of course. The world of sports competition is rife with pseudoscience, false claims, dubious products, superstitions, and magical charms. The most egregious example of this recently has been the energy bracelet scam – multiple companies have and are marketing little bits of rubber, plastic, or metal that you wear on your wrist and they claim (based on parlor tricks rather than evidence) will improve athletic performance. They give classically pseudoscientific explanations for the alleged effect, such as negative ions or energy frequencies. In fact the new icon of the entanglement of sports with pseudoscience is the Power Balance Stadium.

Occasionally the scientific community takes notice of such claims and bothers to review them. Also, in the internet age, the information is actually available to the public (rather than buried in an obscure journal). A recent joint investigation by BBC Panorama and the British Medical Journal (BMJ) recently found a shocking (to them) lack of evidence for many claims made to market performance-enhancing products. The BBC reports:

A team at Oxford University examined 431 claims in 104 sport product adverts and found a “worrying” lack of high-quality research, calling for better studies to help inform consumers.

High quality studies would be nice, but the article fails to ask the question – who is going to fund those studies? What incentive do manufacturers have in proving their products don’t work?

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Posted in: Herbs & Supplements

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Red Yeast Rice and Cholesterol

While much of CAM is ridiculous or implausible, herbal remedies are an exception. Plants produce pharmacologically active substances; in fact, the science of pharmacology grew out of herbalism. Some herbal remedies have not been scientifically tested, but others have been tested and are clearly effective. Nevertheless, these are seldom if ever the best choice for treatment.

One natural remedy stands out. Red yeast rice has been tested and has been shown to lower cholesterol as well as a statin drug. That’s hardly surprising when you realize that it contains the exact same ingredient as the pharmaceutical drug lovastatin.

Only it doesn’t any more.
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Posted in: Herbs & Supplements

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Meet the new drugs, same as the old drugs?

“Targeted therapy.” It’s the holy grail of cancer research these days. If you listen to its most vocal proponents, it’s the path towards “personalized medicine” that improves survival with much lower toxicity. With the advent of the revolution in genomics that has transformed cancer research over the last decade, including the petabytes of sequence and gene expression data that pour out of universities and research institutes, the promise of one day being able to a patient’s tumor, determining the specific derangements in genome and gene expression that drive its uncontrolled proliferation, and finding drugs to target these abnormalities seems more tantalizingly close than ever. Indeed, it seems so close that even dubious practitioners, such as Stanislaw Burzynski, have jumped on the bandwagon, co-opting the terms used by real oncologists and real cancer researchers to sell “personalized gene-targeted cancer therapy,” which in their hands are really no more than a parody of efforts to synthesize the enormous quantity of genomic data each patient’s tumor possesses and figure out how best to take advantage of it, a “personalized genomic therapy for dummies,” if you will.

That’s not to say that there aren’t roadblocks to realizing this vision. The problems to be overcome are substantial, and I’ve discussed them multiple times before. For example, just a couple of weeks ago I discussed an example of just what it takes to apply these new genomic techniques to an individual patient. The resources required are staggering, and, more problematic, there often aren’t any single “magic bullet” molecular pathways identified that can be targeted with existing drugs. The case I discussed was a fortunate man indeed in that such a pathway was identified, but most tumors are driven by many derangements in growth control, metabolism, migration, and the other hallmarks of malignancy described by Robert Weinberg. Worse, in many cases we don’t even have drugs that can attack many of the abnormalities that drive cancer progression. Then there’s the issue of tumor heterogeneity, which comes about because cancer is as good example of a disease as I can think of in which evolution due to natural selection results in incredible differences in the cancer cells in one part of the tumor compared to other parts of the tumor or in the tumor metastases. A “targeted” therapy that targets the genetic abnormalities in one part of the cancer might well fail to target the genetic abnormalities driving another part of the tumor.

These, and many other reasons, are why we haven’t “cured cancer” yet.
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Posted in: Cancer, Clinical Trials

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The Plausibility Problem

From the very outset, the founders of Science Based Medicine have have emphasized the importance of plausibility in the critical evaluation of scientific claims in medicine. What exactly does “plausibility” mean, and how should we apply it in science? My simple definition of plausibility would be “the likelihood that a premise is true.” The application in science is a little more complicated.

Consciously or unconsciously, we all consider plausibility in interpreting events in our lives. For example, if one of your coworkers showed up late for work and grumbled about a traffic jam, you would likely accept his story without question. If, instead, the same coworker attributed his tardiness to an alien abduction, you would not be so charitable. In each case, he has provided the same level of evidence: his anecdotal account. You are likely to accept one story and reject the other because of a perceived difference in the plausibility. The skeptic’s mantra “Extraordinary Claims Require Extraordinary Evidence” expresses this concept in a qualitative way.

Evidence-based medicine has traditionally ignored plausibility when interpreting the evidence for a medical intervention. Science-based medicine, as envisioned by the creators of this blog, includes plausibility when making these judgements.

Since experiment research employs rigorous controls, and statistical criteria, you might assume that plausibility is not an issue, however, this is not entirely true. An article written by John Ioannidis entitled “Why Most Published Research Findings Are False” is cited frequently as a reference for the impact of plausibility on the interpretation of research results. This article enumerates numerous factor leading to erroneous research conclusions. Most of them have been dealt with on this blog at one time or another. To me, the most eye-opening aspect of the paper was a quantitive approach to the influence of plausibility in interpreting positive research findings. I was never taught this approach in medical school, or in any other venue. When it comes to implausible hypotheses, the traditional P-value can be very misleading.

As good as Ioannidis’ article is, it is not easy reading for the statistically or mathematically challenged. What I attempt to do in this post is to demonstrate the importance of plausibility in graphic format, without a lot of complex math. If you can grasp the concepts in this post, you will have an understanding that many researchers, and consumers of research, lack.
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Posted in: Basic Science, Clinical Trials

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The HCG Diet: Yet another ineffective quick fix diet plan and supplement

I contribute biweekly to Science-Based Medicine and could easily devote every post to writing about weight loss supplements, and never run out of topics. As soon as one quick fix falls out of favour, another inevitably replaces it. Some wax and wane in popularity. And pharmacies don’t help the situation. I cringe every time I walk down the aisle where weight loss products and kits are located. Detox? Hoodia? The “fat blaster”?  Here are pharmacists, well educated and perfectly positioned to provide good advice to consumers, but standing behind a wall of boxes with ridiculous weight loss promises.  Yet pharmacists tell me that these products are not only sought out by customers, but they actually sell well. It’s a lost opportunity to provide good advice, and consumers pay the price.

Perhaps because consumers associate these products with pharmacies, I get regular questions about weight loss programs. I end up developing some degree of familiarity with many of them, if only to be able to credibly redirect away from some of the more harmful plans and approaches. It’s that philosophy that I used recently when I was asked about how to best to manage a “plateau” on the HCG diet. I’d never dispensed human chorionic gonadotropin (HCG) before, but knew of its use for the treatment of infertility, where it promotes egg release. But weight loss? I couldn’t think of a mechanism for how HCG could promote weight loss. So I did some digging, and found a long, rich vein of pseudoscience that dates back decades. (more…)

Posted in: Health Fraud, Herbs & Supplements, Naturopathy, Pharmaceuticals

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Holding the Polio Vaccine Hostage

Since the development of the vaccine, perhaps the most effective public health measure we have yet devised, only one human disease has been completely eradicated from the world – smallpox. The last case was reported in Somalia in 1977. Eradication was the result of a deliberate and intense campaign, requiring almost complete vaccination of the population, especially in certain population dense areas. Countries such as India and Nigeria were among the last to achieve eradication. Some of the lessons learned were that very high compliance rates were needed and that even small communities could harbor the virus and prevent eradication.

Several decades later, at the beginning of the 21st century, we are on the verge of eradicating a second major human infectious disease, polio. Like smallpox, polio is a virus that has no major non-human host, so eradication is possible. The polio virus enters the anterior horn cells of the spinal cord, the lower motor neuron – cells that connect the brain to muscles. When those cells die muscles lose their connection causing weakness and atrophy. Vaccine campaigns have successfully eliminated polio from most countries, but the wild type of the virus remains endemic in Nigeria, India, Pakistan, and Afghanistan.

We have the potential, with one final push (which is being spearheaded by the World Health Organization – WHO) to eradicate wild type polio from the world, but these efforts are being hampered by politics and ideology.

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Posted in: Vaccines

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