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A Budget of Anecdotes

Anecdotal evidence. An oxymoron? Or a valid approach to understanding data?

The problem is there are different kinds of anecdotes, used for different purposes, but the purpose of anecdotes is rarely if ever defined explicitly. Anecdotes are used for one purpose by one speaker/writer but interpreted in a different context by the listener/reader. People love anecdotes, especially if the anecdotes are about them or their beliefs. Anecdotes are how patients transmit the particulars of their disease to their health care providers. The medical history, as taken from the patient, is an extended anecdote, from which the particulars of the disease have to be extracted. Anecdotes are how physicians explain disease and treatments. Anecdotes are a tool with which teachers instruct their students. Anecdotes are how CAM proponents validate their particular system, and how skeptics invalidate them.

Anecdotes are useful tools for presenting yourself and your ideas. The convention season is over and is was striking how the candidates attempted to win over voters with anecdotes about their lives rather than the particulars of their policies. Using variations of ‘anecdote’ as a pubmed search term yields little of substance. The predominant theme on medline is to contrast anecdotes with evidence, always to the detriment of anecdotes. Anecdotes have power to influence far greater than evidence.

On The Skeptics Guide to the Universe #165 there was an interview with Ben Goldacre, who noted that there was the popular misbelief that the MMR vaccine was a cause of autism. The belief waned not when the voluminous data on the safety and lack of association with autism and the MMR was released, but when it was discovered that the primary proponent of the MMR/autism link received large sums of money to testify about that MMR/autism link. It was the anecdote about his conflict of interest that invalidated the idea, not the science.

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FDA approval of drugs and transparency in clinical trial results

ResearchBlogging.orgNote: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so.

One thing that science relies on almost absolutely is transparency. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist’s results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it.

Arguably nowhere is this transparency quite as critical as in the world of clinical trials. The reason is that medications are approved on the basis of these trials; physicians choose treatments; and different medications become accepted as the standard of care. Physicians rely on these trials, as do regulatory bodies. Moreover, there is also the issue of publication bias. It is known that “positive” trials, trials in which the study medication or treatment is found to be either efficacious compared to a placebo or more efficacious than the older drug or treatment it is to replace, are more likely to be published. That is why, more and more, steps are being taken to assure that all clinical trial results are made publicly available. For example, federal law requires that all federally-funded clinical trials be registered at ClinicalTrials.gov at their inception, and peer-reviewed journals will not publish the results of a clinical trial if it hasn’t been registered there. Also, beginning September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank,” described thusly. Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial’s registration, generally within a year of the trial’s completion, whether or not these results have been published. Although there are some practical issues over this law, for example determining how much information can be disseminated this way without constituting prior publication, which is normally a reason to disqualify a manuscript from publication.
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Posted in: Clinical Trials, Medical devices, Politics and Regulation, Science and Medicine

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Pitfalls in Regulating Physicians. Part 1

I had intended today’s posting to be a summary of a real case faced by a state medical board. It is a case of licensed physicians treating patients with a substandard, dangerous, and unequivocally illegal method. My intent was to use it as an illustration of how difficult it can be for medical boards to discipline such practitioners, even when the treatment involved is obviously, blatantly bad. Only yesterday, I was informed by the pertinent board that because this case has yet to be resolved, I may not discuss it. So be it: I’ll save the specifics for another time. Instead I’ll offer a general example of a dubious treatment as a prelude to Part 2 of this series,† which will attempt to discover some of the reasons that medical boards might, under such circumstances, be ineffectual.

Intravenous Hydrogen Peroxide

Hydrogen peroxide (H2O2) is a highly reactive compound that is caustic to living tissues. It spontaneously decomposes to water and oxygen, a reaction that is greatly accelerated in the presence of peroxidases (mainly catalase), which are ubiquitous in human blood and tissues. It has been used as a disinfectant for superficial skin wounds and in the mouth, and also for fabric and medical equipment. It has been used as a bleaching agent for teeth and hair. When used as an irrigant in surgical fields, in other large wounds, or consumed in any form (including intravenously), however, it has resulted in predictable, catastrophic complications: arterial and venous gas emboli, emphysema, respiratory arrest, strokes, multiple cerebral infarcts, seizures, colonic ulcers, intestinal gangrene, acute hemolytic crises, shock, cardiac arrest, and death.[1-7]

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Posted in: Health Fraud, Politics and Regulation, Science and Medicine

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Trouble in the Library

Anyone attempting a systematic review of the medical literature on sectarian medical systems (“CAM”) starts with a serious disability; the literature itself. The National Library of Medicine still lists abstracts for over 30 “alternative medicine” journals, but more concerning, is my estimate that half or more of the articles on sectarian systems published in standard medical journals range from the erroneous to the fraudulent. If one is conscientious, honest, and wants to produce a realistic review of sectarian systems that reflects reality, one cannot do it.

The problem spills over and beyond boundaries of medical research and practice. Often neglected is a massive literature of the allied professions – nursing, psychology, social work, and others. There are data bases for these professions as well (CINAL, EMBASE, CISCOM, Psychlit.) So not only do physicians and patients deal with a disabled medical literature, other professions also face the same problem in theirs. Little wonder that the “CAM” – “Integrative” movement has been tolerated instead of rejected in the community of health and allied health.

The editor of Research on Social Work Practice sent me a copy of a review of intercessory prayer published in his journal (Hodge DR, A Systematic Review of the Empirical Literature on Intercessory Prayer. Res Soc Work Pract 2007;17(2):174-186.) Intercessory prayer is the prayer offered by others for an ill person, usually not in the person‘s presence. Prayer is usually performed on a regular daily schedule by groups of prayers of one or more religious denominations.

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Postmodernist attacks on science-based medicine

The postmodernist critique of science consists of two interrelated arguments, epistemological and ideological. Both are based on subjectivity. First, because of the subjectivity of the human object, anthropology, according to the epistemological argument cannot be a science; and in any event the subjectivity of the human subject precludes the possibility of science discovering objective truth. Second, since objectivity is an illusion, science according to the ideological argument, subverts oppressed groups, females, ethnics, third-world peoples.

Postmodernism and science

I detest postmodernism.

Well, it’s not really postmodernism per se that I detest. In the humanities, I don’t mind it so much, although reading postmodernist texts in college did make my head hurt. I suppose that in the humanities postmodernism provides a sometimes useful methodology for providing insights into interpretation of a wide variety of subjects in literature and the arts, although much of the time it seems to exist mainly to try to make texts mean exactly the opposite of what the words on the page say. Relying as it does on deconstruction, which is primarily a form of literary analysis, postmodern analysis is built on questioning the assumptions underlying any text, “deconstructing” its meaning. The problem is, it’s rare that a postmodernist critique of anything doesn’t consist of some of the densest, most impenetrable verbiage in existence.

Since I don’t claim to be a philosopher, and I haven’t studied postmodernism since college, I don’t intend to embarrass myself by trying to do a detailed–ahem–deconstruction of what postmodernism is. Many are the trees that have been killed to write books trying to explain what postmodernism is and how to apply it to various subjects. I do know, however, that postmodern philosphy is skeptical–even nihilistic–when it comes to the values of what is considered “modernity.” Unfortunately, to some, science is one of these modern values that is viewed with extreme skepticism, even to the point of representing the very essence of science as nothing more than one narrative among many. True, Spiro was writing primarily about anthropological science, but medicine is a “soft” enough science to be just as easily attacked in such a manner, and postmodernists don’t limit themselves to the “soft” sciences, anyway. Even worse, these sorts of arguments often claim that science (or, in this case, evidence-based medicine) is nothing more than a sort of hegemony of the power structure being imposed upon the very definition of “data” or “reality,” the implication that it’s us white males whose hegemony is being served (and whose hegemony, presumably, must be resisted) doing the imposing, as if there are no inherent characteristics in science that make it a more reliable means of assessing reality as it exists than, for example, personal anecdote and “experience.”

No wonder woo-meisters and those who hate the very concept of evidence-based medicine (as opposed to the deficiencies in how EBM ranks evidence, which in fact were the reason why this blog is called Science-Based Medicine and not Evidence-based Medcine) love postmodernism so much. It’s the perfect tool for them to appeal to other ways of knowing and try to make it seem as though scientific medicine is no more valid a construct to describe reality than that of the shaman who invokes incantations and prayers to heal, the homeopath who postulates “healing mechanisms” that blatantly contradict everything we know about multiple areas of science, or reiki practitioners who think they can redirect “life energy” (or qi) for therapeutic effect. In the postmodernist realm all are equally valid, as there is no solid reason to make distinctions between these competing “narratives” and the “narrative” of scientific or evidence-based medicine.

Perhaps the best quick explanation of how postmodernism is used to attack science comes from Rob Helpy-Chalk:

Knowledge was always in some way relativized to culture, so that it was possible to talk about many “equally valid ways of knowing” of which enlightenment science was only one. For instance, contemporary biologists say that the cassowary (an ostrich-like creature) is a bird, albeit one that cannot fly. The Karam people of New Guinea, who live alongside the cassowary, say that the cassowary does not belong in the same category as the birds (which they call yakt) but bats do belong to that category. So who’s to say that the biologists are right and the Karam are wrong? Knowledge is all relative.

Claims to knowledge were also always in some way “constructed” or “socially constructed” in the postmodernist movements. This meant that they had less to do with grasping the way the world actually works and more to do with creating social structures that advanced the interests of the people who claimed to have knowledge. The science of thermodynamics was not really a description of the properties of heat. It was about convincing people to buy steam engines and arranging society so that they would be happy when they bought one.

Thus, one of the key tenets of some strains postmodernism is that knowledge is relative and “socially constructed,” usually for the purpose of reinforcing the existing power structure or furthering the interests of the “elite” who have the knowledge. It is therefore not surprising that critics of evidence-based and science-based medicine would find postmodernism to be a very attractive philosophical mantle in which to wrap their objections to the science that does not support their favored understanding of how disease works or what treatments are effective. After all, if all knowledge is relative, then why shouldn’t their way of knowing be just as valid as that of science, given that in the postmodernist view as used (or, as many philosophers would characterize it, abused) by “postmodernist” critics, science is just “another narrative.”
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Posted in: Basic Science, Clinical Trials, Medical Academia, Science and Medicine

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Impossibilities

“If you’ve done six impossible things this morning, why not round it off with breakfast at Milliway’s—the Restaurant at the End of the Universe!”–Douglas Adams

I recently finished reading the book “The Joy of Pi” by David Blatner. There is a chapter about the concept of squaring a circle, also called the quadrature of a circle. The idea is that, with just a ruler and a compass, you construct a square of equal area to a given circle.

It turns out it cannot be done. It is, in this iteration of the multiverse, impossible. Not difficult, or implausible or really hard. Impossible. You cannot square a circle in a finite number of steps given the conditions of using only a ruler and a compass.

That it is impossible does not prevent people from trying. Individuals do derive solutions to squaring the circle, and sometimes the derivation is erroneous, and sometimes they have a solution that requires a new value for pi.

Pi is the ratio of the circumference of a circle to its diameter. Take the circumference of a circle, divide it by its diameter and get the endless, or transcendental, number 3.141592654….(1) That number is part of the fabric of this universe. It is a fundamental part of how life, the universe, and everything is put together (2). It is a curious psychopathology that some people feel that all of known mathematics is wrong, and that they have a solution to an impossible problem and that they have discovered the hither to unknown, one true value of pi as a result.

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National Health Interview Survey 2007 – CAM Use by Adults

The Center for Disease Control (CDC) conducts an ongoing telephone survey of medical problems and health care utilization – called the National Health Interview Survey (NHIS). They recently released their data from 2007. This is the first year for which they specifically broke out questions assessing the use of so-called complementary and alternative medicine (CAM).

CAM is a political/ideological entity, not a scientific one. It is an artificial category created for the purpose of promoting a diverse set of dubious, untested, or fraudulent health practices. It is an excellent example of the (successful) use of language as a propaganda tool.

The fundamental intellectual flaw of “CAM” as a concept is that it is made to include modalities that are extremely diverse, even mutually contradictory, under one umbrella. Very deliberately modalities which are scientific and mainstream, like the proper use of nutrition, are often included under the CAM umbrella by proponents in order to make it seem like CAM is a bigger phenomenon than it actually is, and as a wedge to open the door for the more pseudoscientific modalities.

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Posted in: Public Health, Science and Medicine

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Prepare for Surgery, Heal Faster?

Quacks and their apologists often cite surgery and emergency treatments of traumatic injury and a few other catastrophic or potentially catastrophic events as the only ”conventional” or “allopathic” methods that they consistently recommend. Explicitly or implicitly, for most problems they tout “holistic” or “CAM” treatments. In modern medicine, however, there are plenty of non-surgical and non-emergency treatments whose outcomes are so manifest that even the most exuberant advocates of implausible medical claims (IMC) seem careful to steer clear, lest they blow their cover. Where are the promoters or consumers of homeopathic contraceptives? Why haven’t we heard of a chiropractic adjustment for high blood sugar? How many pitches for Ayurvedic treatments of gout have you seen? There are exceptions, of course, the most notable being the nearly ubiquitous anti-immunization stance among IMC promoters.

Anesthesiology and Implausible Claims

In my day job I specialize in anesthesiology, a non-surgical field whose methods are so obviously effective that little is heard from the IMC crowd. Consider: is it likely that even the slickest of the current crop of snake oil salesmen, if they had the bad sense to try, could talk many people into accepting an implausible method for rendering the body insensible to pain? No, that would require a more effective form of persuasion, such as that used in China to promote “acupuncture anesthesia” from the mid-1950s until the end of the Cultural Revolution in 1976. That’s a story I’ll tell another time.

A few other implausible claims have crept into the broader realm of anesthesiology. Stimulation of the “pericardial 6″ acupuncture point on the ventral aspect of the wrist is said to prevent post-operative nausea. There is little basis for this, the Cochrane Review notwithstanding. Verbal messages, given to a patient under general anesthesia, are said to result in “faster healing.” The major proponent of this claim is Peggy Huddleston, a self-described psychotherapist with an M.T.S. (Master of Theological Studies) degree from the Harvard Divinity School. Ms. Huddleston appears to have parlayed the “faster healing” claim into a successful entreprenurial venture, featuring a website, workshops, CDs, and a book:

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Posted in: Book & movie reviews, Science and Medicine

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The Importance and Limitations of Peer-Review

Peer-review is a critical part of the functioning of the scientific community, of quality control, and the self corrective nature of science. But it is no panacea. It is helpful to understand what it is, and what it isn’t, its uses and abuses.

Overview

When the statement is made that research is “peer-reviewed” this is usually meant to refer to the fact that it has been published in a peer-reviewed journal. Different scientific disciplines have different mechanisms for determining which journals are legitimately peer-reviewed. In medicine the National Library of Medicine (NLM) has rules for peer-review and they decide on a case by case basis which journals get their stamp of approval. Such journals are then listed as peer-reviewed.

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Posted in: Clinical Trials, Science and Medicine

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Snipers – A Short Reflection

The blogosphere held no fascination for me before my involvement with sciencebasedmedicine.com. I had checked into a few blogs, and found some capturing attention, allowing exploration of ideas and personal views in greater scope than allowed for in scientific papers. But many seemed not to expand discussion after an original post.  When the blogger would describe some series of events or ideas, there would follow a series of pro and con short commentaries, whose authors seemed to enjoy sniping at irrelevant issues. The emotional level rose with each series of exchanges. One had to search for pages with comments that expanded knowledge, and were not just argumentative.Some commenters took off on small details in the original.. Then ensued a series of yes I did – no I didn‘t, you said – I said, you said – I meant, you‘re a blank – you’re a worse blank, and on, as readers know.

I wrote an article or two for an online ‘zine, and the format allowed for extended exchanges, like the blogs. Comments followed a similar pattern. They continued for 2 weeks. Same thing happened when I critiqued traditional Chinese medicine, implausible claims, ethics of “CAM” in editorials in an online journal. Questions there were screened by editors, but I filled more space  elaborating answers than I was allowed by the word limit to the original articles. I noted that even news items in online news sources were followed by series of comments, challenges, counterchallenges and on they went, often getting uncomfortably personal. Lost in some of this was the meat of the original article as small point after smaller point appeared.

All this is old stuff to most of you readers, but to me, it was new. And I wondered not only about the format and policies that allowed ongoing sniping, but had to look at my own reactions, often surging in the same direction of telling people off. I keep telling myself not to answer snipes, but the temptation sometimes wins. Too much chance to show cleverness and to enjoy that basic, innate joy of putting it to someone who wrote something that really ticked me off.
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