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Rambling Musings on Using the Medical Literature

For those who are new to the blog, I am nobody from nowhere. I am a clinician, taking care of patients with infectious diseases at several hospitals in the Portland area. I am not part of an academic center (although we are affiliated with OHSU and have a medicine residency program). I have not done any research since I was a fellow, 20 years ago. I was an excellent example of the Peter Principal; there was no bench experiment that I could not screw up.

My principal weapon in patient care is the medical literature, accessed throughout the day thanks to Google and PubMed. The medical literature is enormous. There are more than 21,000,000 articles referenced on Pubmed, over a million if the search term ‘infection’ is used, with 45,000 last year.

I probably read as much of the ID literature as any specialist. Preparing for my Puscast podcast, I skim several hundred titles every two weeks, usually select around 80 references of interest and read most of them with varying degrees of depth. Yet I am still sipping at a fire hose of information

The old definition of a specialist is someone who knows more and more about less and less until they everything about nothing. I often feel I know less and less about more and more until someday I will know nothing about everything. Yet I am considered knowledgeable by the American Board of Internal Medicine (ABIM), who wasted huge amounts of my time, a serious chunk of my cash, and who have declared, after years of testing, that I am recertified in my specialty. I am still Board Certified, but the nearly pointless exercise has left me certified bored. But I can rant for hours on Bored Certification and how out of touch with the practice of medicine the ABIM is.

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Posted in: Clinical Trials, Science and Medicine

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The Meaning of Secondary Prevention

A November letter to the editor in American Family Physician chastises that publication for misusing the term “secondary prevention,” even using it in the title of an article that was actually about tertiary prevention.

I am guilty of the same sin. I had been influenced by simplistic explanations that distinguished only two kinds of prevention: primary and secondary. I thought primary prevention was for those who didn’t yet have a disease, and secondary prevention was for those who already had the disease, to prevent recurrence or exacerbation. For example, vaccinations would be primary prevention and treatment of risk factors to prevent a second myocardial infarct would be secondary prevention.

No, there are three kinds of prevention: primary, secondary and tertiary. Primary prevention aims to prevent disease from developing in the first place. Secondary prevention aims to detect and treat disease that has not yet become symptomatic. Tertiary prevention is directed at those who already have symptomatic disease, in an attempt to prevent further deterioration, recurrent symptoms and subsequent events. (more…)

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Of SBM and EBM Redux. Part III: Parapsychology is the Role Model for “CAM” Research

This is the third post in this series*; please see Part II for a review. Part II offered several arguments against the assertion that it is a good idea to perform efficacy trials of medical claims that have been refuted by basic science or by other, pre-trial evidence. This post will add to those arguments, continuing to identify the inadequacies of the tools of Evidence-Based Medicine (EBM) as applied to such claims.

Prof. Simon Replies

Prior to the posting of Part II, statistician Steve Simon, whose views had been the impetus for this series, posted another article on his blog, responding to Part I of this series. He agreed with some of what both Dr. Gorski and I had written:

The blog post by Dr. Atwood points out a critical distinction between “biologically implausible” and “no known mechanism of action” and I must concede this point. There are certain therapies in CAM that take the claim of biological plausibility to an extreme. It’s not as if those therapies are just implausible. It is that those therapies must posit a mechanism that “would necessarily violate scientific principles that rest on far more solid ground than any number of equivocal, bias-and-error-prone clinical trials could hope to overturn.” Examples of such therapies are homeopathy, energy medicine, chiropractic subluxations, craniosacral rhythms, and coffee enemas.

The Science Based Medicine site would argue that randomized trials for these therapies are never justified. And it bothers Dr. Atwood when a systematic review from the Cochrane Collaboration states that no conclusions can be drawn about homeopathy as a treatment for asthma because of a lack of evidence from well conducted clinical trials. There’s plenty of evidence from basic physics and chemistry that can allow you to draw strong conclusions about whether homeopathy is an effective treatment for asthma. So the Cochrane Collaboration is ignoring this evidence, and worse still, is implicitly (and sometimes explicitly) calling for more research in this area.

On the other hand:

There are a host of issues worth discussing here, but let me limit myself for now to one very basic issue. Is any research justified for a therapy like homeopathy when basic physics and chemistry will provide more than enough evidence by itself to suggest that such research is futile(?) Worse still, the randomized trial is subject to numerous biases that can lead to erroneous conclusions.

I disagree for a variety of reasons.

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Posted in: Acupuncture, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Herbs & Supplements, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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Compare and Contrast

I have been in Infectious Diseases for almost 25 years. I have two major jobs: I see inpatient consults and I chair the Infection Control program. I have been involved in quality improvement, especially as it relates to hospital acquired infections, for my entire career. It has been an interesting quarter century. Year after year we have driven down infection rates and other kinds of mortality and morbidity in hospitalized patients. Everyone recognizes that medicine is difficult and dangerous and its biggest problem is medicine is practiced by humans, who, I would venture to observe, are prone to mistakes and any number of cognitive errors.

It has not been a easy journey. People hate change and there has not always been certainty as to the best options to choose to solve a problem, a problem that continues today. For example, how best to treat a patient with potential methicillin resistant Staphylococcus aureus colonization (MRSA). Should we screen everyone? Screen high risk patients? Surgical patients? Do we decolonize, with the long term consequence of accelerating antibiotic resistance? Do we place everyone with MRSA in isolation, with the known decrease in care that patients in isolation may have? Everything we do has potential downsides and unintended consequences. No good deed ever goes unpunished.

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Posted in: Acupuncture, Chiropractic, Science and Medicine

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For Good Reason…

This one crept up on me by surprise. You see, I recorded an interview with D.J. Grothe, President of the James Randi Educational Foundation and host of the podcast For Good Reason back in November. I wasn’t sure when it would appear. Well, it turns out that it popped up on my iTunes podcast feeds sometime over the last few days. (It’s been really busy at work, and I haven’t really been paying attention to podcasts–at least, not until yesterday.)

So, here it is. I haven’t listened to it all yet, but hopefully I explained myself well enough and did credit to my fellow SBM bloggers. DJ is a good interviewer, which means he presses his subjects a bit and sometimes gets them out of their comfort zone.

Posted in: Science and Medicine

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California Forbids Chinese Bloodletting

In November 2010, the California Department of Consumer Affairs (DCA) finally decided to act responsibly and forbid the prevalent practice of Chinese bloodletting by licensed acupuncturists.

The practice became a concern for the DCA when allegations of unsanitary bloodletting at a California (CA) acupuncture school surfaced.

The incident allegedly occurred during a “doctoral” course for licensed practitioners. The instructor was reportedly demonstrating advanced needling and bloodletting techniques. During the process, he took an arrow-like lancing instrument that is called a “three-edged needle” (三棱针), sharpened it with sandpaper, cleaned it with alcohol, and then asked a student-volunteer to roll a towel around his neck (similar to what is depicted in Image 1). The instructor then cleaned the student’s temporal region with alcohol, and punctured a superficial blood vessel with the arrow-like instrument. The student then held his head over the garbage can, gushing blood for a while.

Images 1 & 2. Chinese bloodletting. Image 1 shows a technique used to bleed the head or the face, where a towel is rolled around the neck to control the arterial pressure. Image 2 shows the practice of “wet cupping.”

The ancient practice of bloodletting, with or without cupping, is still widely used in Chinese medicine to remove “stagnant blood, expel heat, treat high fever, loss of consciousness, convulsion, and pain.”1 The amount of blood let depends on the condition, and the location of the incision. A contemporary book recommends letting a tiny amount from a point adjacent to the thumbnail for a condition described as “wind-heat invasion” of the lung. The symptoms associated with this unscientific nomenclature include chills and fever, sore throat, stuffy or runny nose, and a yellow discharge,2 which could correspond to many respiratory conditions, including the common cold, influenza, pneumonia, etc.
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Posted in: Acupuncture, Public Health, Science and Medicine

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CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1
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Posted in: Homeopathy, Legal, Science and Medicine

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The “decline effect”: Is it a real decline or just science correcting itself?

‘Tis the season, it would seem, for questioning the scientific method.

You might recall that back in October, I was a bit miffed by an article in The Atlantic entitled Lies, Damned Lies, and Medical Science and expressed my annoyance in one of my typical logorrheic posts. Then, a mere couple of weeks later, Steve Simon wrote a rather scathing criticism of the very concept of science-based medicine, which I ended up answering, again in my usual inimitable logorrheic fashion. Unfortunately, these things often come in threes. Well, maybe not always threes. It’s not as though this “rule” is anything like the count for the Holy Hand Grenade of Antioch, where “Four shalt thou not count, nor either count thou two, excepting that thou then proceed to three. Five is right out.” Except that five isn’t always right out when it comes to these sorts of criticisms of science and/or science-based medicine.

But enough of my pathetic attempt to channel Mark Crislip. The third count in articles expressing skepticism of the scientific method and science-based medicine comes, for purposes of my discussion, in the form of an article in The New Yorker by Jonah Lehrer entitled The Truth Wears Off: Is There Something Wrong With the Scientific Method? Unfortunately, the full article is restricted only to subscribers. Fortunately, a reader sent me a PDF of the article; otherwise, I wouldn’t have bothered to discuss it. Also, Lehrer himself has elaborated a bit on questions asked of him since the article’s publication and published fairly sizable excerpts from his article here and here. In any case, I’ll try to quote as much of the article as I think I can get away with without violating fair use, and those of you who don’t have a subscription to The New Yorker might just have to trust my characterization of the rest. It’s not an ideal situation, but it’s what I have to work with.
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Posted in: Clinical Trials, Science and Medicine, Science and the Media

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Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

Review

This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”

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Posted in: Chiropractic, Clinical Trials, Energy Medicine, Health Fraud, History, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

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Good Idea, Bad Execution: Dosing Errors, A Preventable Harm

We spend a lot time at SBM discussing different elements of the art and science of medicine, and how we believe that practice can be improve. Yet our science-based intentions can be thwarted at the last possible moment – in the form of dosing errors. The workup may have been comprehensive, the diagnosis could be correct, the most clinically and cost-effective intervention chosen, and whammo. An overdose or underdose, possible toxicity, and a failure to achieve the desired outcome. It’s a completely avoidable, but often overlooked aspect of the practice of medicine.

In my last post, I noted how cough and cold products for children have largely been withdrawn from the market due to their lack of efficacy, and the risks related to toxicity. Today’s post is going to dive a little more deeply into factors that can contribute to toxicity in the pediatric population. Let’s start with a vignette that may be familiar to parents:

The new father is wakened from a blissful, deep sleep by a crying child. Once Dad realizes when and where he is, and the source of the crying, he silently curses the short duration of action of the acetaminophen liquid he gave his child at bedtime. It has probably worn off already, and the fever is back.  Stumbling into his child’s room in the dark, he can feel the heat radiating off his body.  He fumbles around for the Tylenol, and something to measure it with. He can’t find the dropper bottle, but finds a bottle of syrup. It’s hard to measure the dose in the dark, and the medicine cup he finds is hard to read. “I think the dose is a teaspoon..that’s 5mL”.  He pours the medicine into his child’s throat, tucks him back into bed, and both are back asleep within minutes.

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