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What Do You Expect From Your Pharmacy?

What evidence standard should exist for health products sold in pharmacies? That’s today’s bleg, and I’m seeking your input.

In most countries, pharmacy is a registered, self-regulated health profession, with a responsibility to optimize the use of drugs. Pharmacist education consists of several years of university-level education and practical training in real-world health care settings. Pharmacists with advanced degrees and post-graduate residencies are common. Not all pharmacists work in community (retail) pharmacies, but that’s where many pharmacists end up, and it’s the public face of the profession.

In most countries, pharmacies are private businesses, either owned by a pharmacist or by a corporation. They are granted a privileged and exclusive right in the provision of health care: certain health products (both prescription and non-prescription) are only available in pharmacies, because pharmacist consultation and availability has been deemed necessary to maximize the safe use of these products. While it’s a setting for health care (and often the first point of contact into the system), retail pharmacy is a business. Pharmacies count on the retail sale of products for revenue and traffic. And in general, pharmacies have the legal right to stock and sell whatever products they want. Tobacco is one exception, where it is no longer sold in most Canadian pharmacies, but remains prevalent in American pharmacies. And as I discussed in a prior post, when we look internationally there can be considerable differences between which drugs are prescription, and these that can be sold over-the counter.

How Much Evidence?

The evidence standard for products sold in pharmacies is facing increasing scrutiny. Concerns have been raised in several countries that pharmacies may be taking advantage of their privileged status as provers of prescription drugs, and are selling products that aren’t supported by good scientific evidence. Some recent examples:
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Posted in: Pharmaceuticals, Politics and Regulation

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Narcotic treatment contracts and the state of the evidence

Opium derivatives—and later, synthetic opioids—have probably been used for millennia for the relief of pain. Given human biology, they’ve probably been abused for just as long. Opiate use disorders are a daily fact for primary care physicians; the use of these drugs has become more and more common for chronic non-cancer pain. These medications are very effective in the treatment of pain, but come with a lot of undesired effects, not least among them the potential of developing a substance use disorder. They also have considerable street value, with Vicodin selling for $5-$10 per tablet on the illicit market.

But our options for the treatment of pain are not unlimited. Non-steroidal anti-inflammatory medications such as ibuprofen are not safe in all patients, and are not always effective. A multi-modal approach to the treatment of chronic pain can be very helpful, but many patients do not have access to this expensive treatment, and many more simply want instant relief, something which opiates can provide, but with a price.

The abuse of prescription opiates is on the rise. Continuing with Vicodin as an example, 9.3% of American 12th graders reported using Vicodin illicitly in a recent survey. From 1994 to 2002, the mention of hydrocodone—the narcotic in vicodin–in emergency center charts increased 170%. This is a big problem.

So we have two big problems: chronic pain, and narcotic abuse. How can we treat chronic pain and avoid contributing to substance use disorders and drug diversion? One strategy has been the use of so-called narcotic contracts, which we’ve discussed at length. But absent from that discussion was the evidence.

Before we look at this evidence, we must re-examine our reasons for using these contracts. In my own practice, we generally use them to protect ourselves from becoming involuntary drug dealers, and to prevent patients from abusing the narcotics we prescribe. So how are we doing with that? (more…)

Posted in: Science and Medicine

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Another overhyped acupuncture study misinterpreted

acupinhead

Perhaps the most heavily studied of “alternative medicine” modalities is acupuncture. Although it’s hard to be sure as to the reason, I tend to speculate that part of the appeal to trying to do research in this area is because acupuncture is among the most popular of actual “alt-med” modalities, as opposed to science-based medical modalities co-opted by believers in alt-med and rebranded as “alternative” (diet and exercise, for instance, to which is all too often added the consumption of huge quantities of unproven nutritional supplments) or activities that make people feel better, whether they’re healthy or ill (massage, for instance). In contrast, acupuncture involves actually sticking needles into the skin. Never mind that the rationale for acupuncture, namely “redirecting” the flow of the “life energy” known as qi when it is blocked by sticking needles in “meridians” like some electrodes in some imaginary qi battery, is pure bunkum, as we’ve pointed out here at SBM time and time again. Somehow the image of needles sticking out of the skin, apparently painlessly and making some extreme acupuncture practices resemble Pinhead from the Hellraiser movie series, seems “sexy” as far as “alternative” therapies go, particularly since it’s “Eastern” as opposed to that reductionistically evil “Western medicine,” and, as we all know at SBM, “Western” is bad and “Eastern” is good.

So the fascination with acupuncture remains, so much so that an inordinate amount of research dollars are spent on studying it. Unfortunately, that money is largely wasted. As Steve Novella has pointed out, in general in medicine (at least these days), the trajectory of research is usually from bench research to animal models to small scale, less rigorous, pilot studies in humans to large scale, rigorously designed studies using many subjects. True, this order doesn’t always hold. For instance, if physicians make a compelling observation “at the bedside” of response to therapy or how a disease progresses, frequently, after making closer observations to confirm the initial observation, researchers will jump back to animal models and bench top research to try to figure out what’s going on. For such a progression to be useful, though, scientists have to be sure that the phenomenon in human patients under study actually exists.

Unfortunately, in acupuncture, the evidence is still unconvincing that there is any “there” there in that acupuncture effects appear to be no greater than placebo effects. As larger, more well designed studies using real placebo or sham acupuncture techniques, have increasingly shown that acupuncture does not function any better than placebo in human beings (and sometimes even worse), acupuncturists and acupuncture believers have been reversing the usual order of things, doing smaller studies and “pragmatic” (i.e., uncontrolled) clinical trials, where the placebo effect is not controlled for. Never mind that it doesn’t matter where the needles are placed (thus blowing the whole “meridian” idea out of the water) or even if the needles puncture the skin. Toothpicks work just as well as needles. Also never mind that the mythology of acupuncture as having been routinely practiced for over two thousand years (or, sometimes, four thousand years, is largely a creation of Chairman Mao, who elevated what was a marginal practice at the time to a modality that the state supported and promoted (1,2,3,4). Unfortunately, even the National Center for Complementary and Alternative Medicine (NCCAM) falls for this mythology.

Every so often, I’m amazed when an acupuncture study ends up in a high impact journal like Nature Neuroscience. Of course, when I read such articles, virtually inevitably I discover that what is being studied is not really “acupuncture” per se, but rather sticking needles into either people or animals. Sometimes, “electroacupuncture” (which is in reality not acupuncture at all, given that there was no source of electricity hundreds of years ago in China when acupuncture was supposedly invented) is misrepresented as acupuncture. Since a bunch of readers, both here and at my other blog, have deluged my mail box with this particular study, I felt obligated to have a look at it, even if Steve Novella has already weighed in with his excellent deconstruction. This particular study is especially annoying, because it’s been hyped to the nth degree, and even some news sources where the reporters should know better have fallen for it.
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Posted in: Acupuncture, Science and the Media

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Potential New Mechanism of Pain Relief Discovered

From the Wikimedia Commons.

From the Wikimedia Commons.

The development of drugs and other treatments for specific symptoms or conditions relies heavily on either serendipity (the chance finding of a beneficial effect) or on an understanding of underlying mechanisms. In pain, for example, there are limited ways in which we can block pain signals – such as activating opiate receptors or inhibiting prostaglandins. There are only so many ways in which you can interact with these systems. The discovery of a novel mechanism of modulating pain is therefore most welcome, and has the potential of leading to entirely new treatments that may have better side-effect profiles than existing treatments and also have additive clinical effects.

A recent study by Nana Goldman et. al., published in Nature Neuroscience, adds to our understanding of pain relief by identifying the role of adenosine in reducing pain activity in the peripheral nervous system. The researchers, in a nice series of experiments, demonstrated that producing a local painful stimulus in mice causes the local release of ATP (adenosine triphosphate) that peaks at about 30 minutes. This correlates with a decreased pain response in the mice. Further, if drugs are given that prolong the effect of adenosine, the analgesic effect itself is prolonged.

Also, if drugs are given that activate the adenosine A1 receptor, the observed analgesic effect is replicated. When these experiments are replicated in knockout mice that do not have the gene for the adenosine A1 receptor, there is no observed analgesic effect.

Together these experiments are fairly solid evidence that local pain results in the local release of adenosine that in turn binds to the adenosine A1 receptor inhibiting the pain response. This is potentially very exciting – it should lead to further investigation of the adenosine A1 receptor and the effects of activating and inhibiting it. This may lead to the development of drugs or other interventions that activate these receptors and may ultimately be a very useful addition to our ability to treat acute and chronic pain.

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Posted in: Acupuncture, Neuroscience/Mental Health

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The Weekly Waluation of the Weasel Words of Woo #10

The W^5/2 Hits Double Figyiz!

OK, I gotta admit that my friend Orac moved me to render this Special 10th Edition of the W^5/2™ (after a brief hiatus) by mentioning it today in the context of an article that used, er, the topic of our venerable game to great advantage! Some of it is brilliant, unprecedented even:

Perhaps most tellingly, the U.S. Internal Revenue Service approved acupuncture as a deductible medical expense in 1973.

My hat is off to whoever came up with that one! Hey, y’gotyer basic logical fallacies, right? Y’gotyer appeal to tradition, yer appeal to popularity (or, as Orac put it, yer argumentum ad populum—sheece, is he a snob er what?), yer appeal to authority, which, I shpoze, an appeal to the IRS is a species of, as it were (hmmm: is that appeal heard in Tax Court?)…but there’s something just a little more special about this than just that. Therefore I propose, in the Tremendous (and Trendy!) Tradition of Trademarked Titles long associated with the Wonderful W^5/2™, a bran’, spankin’ new fallacy of its own, presented, of course, in a tasteful Madison Avenue format:

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Posted in: Acupuncture, Homeopathy, Humor, Science and Medicine, Science and the Media

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Nine differences between “us and them,” nine straw men burning

I’ll start this post by admitting right up front: I blatantly stole the idea for the title of this post from Mark Crislip’s most excellently infamous post Nine questions, nine answers. Why? Because I really liked that post and felt like it. Also, there seems to be something about the number nine among anti-vaccine zealots: Nine “questions.” Nine circles of hell.

Nine straw men.

I’m referring to an amazing post that appeared on the anti-vaccine crank blog Age of Autism over the weekend by contributing editor Julie Obradovic entitled The Difference Between You and Me. In this post, Julie describes not one difference, but nine differences, that she perceives between herself (and, apparently, by generalization other parents who have become believers in the myth that vaccines cause autism) and people like SBM contributors and (I hope) the vast majority of our readers, who support science-based medicine, understanding that correlation does not necessarily equal causation and that, most importantly, science not only does not support the belief that vaccines cause autism but provides us with copious evidence that there almost certainly no link between the two. Actually, there are more than nine differences, as Ms. Obradovic packs multiple apparently related differences around each of her nine “differences” and then complains that Alison Singer and, apparently by generalization the rest of us who support SBM and oppose the anti-vaccine movement, misrepresent the reasons why she and her merry band of anti-vaccine activists reject the science that has failed spectacularly to validate their deeply held belief that vaccines cause autism and all sorts of other health consequences. Her post ends up being a collection of straw men constructed to Burning Man size, each of which she then applies a flamethrower of burning nonsense to with self-righteous gusto.
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Posted in: Public Health, Science and the Media, Vaccines

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Brief Note: The Chiropractic Subluxation is Dead

The General Chiropractic Council, a UK-wide statutory body with regulatory powers, has just published a new position statement on the chiropractic subluxation complex:

The chiropractic vertebral subluxation complex is an historical concept but it remains a theoretical model. It is not supported by any clinical research evidence that would allow claims to be made that it is the cause of disease or health concerns.

They remind chiropractors that they must make sure their own beliefs and values do not prejudice the patient’s care, and that they must provide evidence-based care. Unfortunately, they define evidence-based care as

clinical practice that incorporates the best available evidence from research, the preferences of the patient and the expertise of practitioners, including the individual chiropractor her/himself. [emphasis added]

This effectively allows “in my experience” and “the patient likes it” to be considered along with evidence, effectively negating the whole point of evidence-based medicine.

Posted in: Chiropractic

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Andrew Wakefield Fights Back

Dr. Andrew Wakefield was almost single-handedly responsible for frightening the public about a possible association between autism and the MMR vaccine. His alarmist recommendations directly led to lower vaccination rates and a resurgence of measles to endemic levels in the UK. The MMR/autism interpretation of his 1998 article in The Lancet was retracted by 10 of his 12 co-authors. The article itself was “fully retracted from the public record” by The Lancet. And now Wakefield has lost his license to practice medicine after the General Medical Council’s exhaustive 2½-year review of his ethical conduct.

His career was in shreds and there was only one way left for him to fight back: to write a book. Callous Disregard: Autism and Vaccines — The Truth Behind a Tragedy has just been published. I tried hard to read it with an open mind and to understand his point of view. He did make some points that I will accept as valid unless they can be refuted by the others involved. Some of what he said and did was apparently misinterpreted and distorted by his critics. But the book did not convince me that he was an ethical, rigorous scientist or that MMR is linked to autism or to bowel disease. In my opinion the book does nothing to scientifically validate his beliefs or to excuse his behavior, but rather boils down to self-serving apologetics and misleading rhetoric. It also undermines his claim that he is a good scientist by showing that he values anecdotal evidence (“listening to the parents”) over experimental evidence. (more…)

Posted in: Book & movie reviews, Vaccines

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Lying Liars and their Lying Lies

Carlyle said “a lie cannot live.” It shows that he did not know how to tell them.

— Mark Twain

There is an infamous hoax from last century called The Protocols of the (Learned) Elders of Zion, an anti-Semitic text purporting to describe a plan to achieve global domination by the Jewish people. Despite the fact that the Protocols is a work of fiction, there have been and still are folks who believe it to be real, from Hitler on down. (Or is that “on up”? Can one be lower than Hitler? And have I already committed a breach of Godwin’s Law?)

Inventing apparently legitimate information is a useful propaganda device not limited to anti-Semites. Having people appear evil or uncaring using their own words is far more effective than calling them evil and uncaring.

There are many in the community who suffer from a variety of complaints that I cannot diagnose, and, as people do not like uncertainty about their health, they will find someone who will give them a diagnosis. Not infrequently they will come upon the idea of chronic Lyme disease.

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Posted in: Health Fraud, Medical Ethics, Science and Medicine

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Fields, Alternative Medicine, and Physics

In 1996 the American Physical Society, responding to a request from the National Research Council, was asked to examine the potential health hazards of power lines. One of the concerns was that electromagnetic background fields of 2 milligauss might cause cancer (for comparison the earth’s magnetic field is 500 milligauss and fields generated by human physiological processes are hundreds of thousands of times less than 2 milligauss). Monitors of outdoor exposure for children to wear were marketed to parents. “Some city regulations sought to constrain B fields to less than 2 milligauss”. The report, which was a comprehensive study of the alleged dangers, included both molecular and epidemiologic studies and found that no adverse health effects could be attributed to these low fields.

One of the conclusions emphasized that physical calculations rule out carcinogenic effects because at physiological temperatures thermal noise fields in human cells are larger than the background fields from power lines.1, 2 Thus the political agenda, concerned with fear of carcinogenic mechanisms arising from low level magnetic fields, lost credibility. However, about 10 years later claims for health effects from mattress pads equipped with small magnets were marketed. A study of this was funded by National Institute of Health’s Center for Complementary and Alternative Medicine and claims for their benefits were published in alternative medicine journals.3

Some of the rationale for the claims were ludicrous. I attended one sales pitch which claimed their mattress magnets were better because they incorporated only North Poles. About  the same time, small 300 gauss magnets, began to appear on the shelves of drug stores. In 2007 a lawsuit brought by the National Council against Health Fraud against advertisers of these products was successfully settled. I was one of the persons who agreed to appear as an expert witness if needed. The Federal Trade Commission also threatened to prosecute purveyors who claimed healthful benefits for these products.
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Posted in: Basic Science

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