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Homeocracy

Recent comments on homeopathy again resulted in references to the 1994 Pediatrics paper by Jacobs et al on use of homeopathic remedies for childhood diarrhrea.  The authors of that paper concluded from their blinded study that homeopathic remedies, tailored to the individual infants and children, were effective in reducing the number of diarrhea stools and thus in shortening the illness.  The paper has been widely referenced and reported to have proved  homeopathy efficacy, and the critiques have been argued by homeopaths as irrelevant, as has been done by Mr. Ullman.

In this short series I want to recount my experience with the report, its predecessor, and its two major sequellae, as well as its effect on systematic reviews of homeopathy.  I will begin with a description of the first two studies, concentrating on their methods. Then I will discuss the results of the 1994 Pediatrics report and the authors’ interpretation of the results. Then (I hope last) I will discuss the third paper which the authors claimed supported findings of the first two and the meta-analysis which combined data from all three. If you are imagining why this  series interests me, and imagining the worst, you are probably right. The sequence will  help to reveal how some of the information in “holistic” and “alternative” systems become published, and despite critiques and disproofs through a sort of systematic deconstructions, still develop wheels of their own and enter the fund of general knowledge seemingly forever. Or, at least for several decades, until a social belief switch is finally turned off.
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Posted in: Basic Science, Clinical Trials, Homeopathy

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NCCAM is a victim of its own history

Let me begin with a story. An assistant professor submits a reasonable application to NCCAM to investigate the potential metabolic and pharmacodynamic interactions of St. Johns wort with conventional chemotherapy. This was the year or year-and-a-half before SJW was known to have significant CYP3A4 inductive activity due primarily to its component, hyperforin. Said investigator used this preliminary data, not explicitly required for theNIH funding mechanism (called an R21), to question whether St. John’s wort used by depressed cancer patients might interfere with chemotherapy. The original proposal earned a priority score of 228 (as with golf, the lower the better: the best is 100, the worst is 500.)

The major reviewer critique was that the assistant professor, Your Humble Pharmacologist, lacked, at the time, significant natural products chemistry expertise. YHP was then doing his sabbatical in the NC Research Triangle area and wisely sought the support and expertise of the now-late Dr. Monroe Wall and surviving Dr. Manuskh Wani. These gentlemen discovered and solved the structures of taxol from Taxus brevifolia and camptothecin from Camptotheca acuminata. Taxol itself became a blockbuster drug for Bristol-Myers Squibb while camptothecin required water-soluble modifications to foster topotecan (Hycamptin) and irinotecan (Camptosar) that collectively saved or prolonged the lives of thousands of men and women subjected to breast, ovarian, lung, and gastrointestinal tumors. In 2003, they received the designation of an American Chemical Society National Historic Chemical Landmark for their three decades of work in this area. (Sadly, they received none of the profits from these drugs as their discoveries pre-dated the Bayh-Dole Act that allowed NIH funded researchers to share in the revenues of intellectual property emerging from their work.).

Being a savvy young investigator, I sought and enlisted the assistance and support of Dr. Wall and colleagues to provide my team with world-class, natural products expertise. Stunningly, the subsequent application was awared a score of 345 (*much worse than the original) with the criticism from reviewers that all Dr. Wall did was to lend a drug development aspect to an otherwise “herbal” applicaton.

To this day, I cannot fathom who better I could have sought for natural products expertise on this grant application.

Since then, three of my colleagues and I have submitted 13 applications to NCCAM, including an application for a comprehensive Botanical Research Center grant. All 13 received unfundable scores. Among these was a 279-page application for a NCCAM Botanical Research Center – reviewed but not discussed by the evaluation panel.

Nonetheless, I have taken the approach that if NCCAM were to continue its existence, I would try to be part of the solution.  I have accepted several invitations to review research and training grants for NCCAM and I am pleased to say that one or two projects that I ranked highly ended up being very productive, specifically in the area of natural products and traditional herbal medicines.  I also have some friends and valued colleagues who contribute to the scientific integrity of NCCAM. However, my collective experiences lead me to believe that they are voices quenched by the vast wilderness of the promotion and advocacy of “integrative medicine” and CAM.
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Posted in: Basic Science, Herbs & Supplements, Politics and Regulation, Science and Medicine

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Fakin’ it

Last week the Times of London revealed inside information from the General Medical Council (UK, responsible for physician licensing) of an ongoing investigation of Dr. Andrew Wakefield and from its own investigation. This revelation recalled other instances of fakery from reports of sectarian medicine (“CAM”) successes. The Medical Council information contained evidence that the data from the now famous Wakefield cases used to claim an association of the MMR vaccine with childhood autism and inflammatory bowel disease were misinterpreted, altered, and to some extent, faked. The report and history were reviewed by David Gorski last week. In eight of twelve cases, the dates of autism onset were “rearranged” to fit the needed time association, and many small bowel biopsies were “reinterpreted” to show inflammation.

The Wakefield claims were long suspected by reputable medical scientists and skeptics  as being erroneous or fraudulent.  Note: the Council hearings are still in progress, and the Times report is subject to legal complaint.  The original details can also be seen in the Times articles.

This expose’ adds to a growing list of reports with erroneous and faked information in medical journals used either for economic reward, undeserved fame, or to promote ideological claims for medical sects and cults. Although history of erroneous or false claims goes back hundreds of years, the altering or synthesizing of data passing the recently conceived peer review system is new,  illuminating defects in the journal peer review and editing system.

If journals were invented in the 18th century, and operated like journals of today, Mesmer’s demonstrations might have been published, and the Ben Franklin and Antoine Lavoisier and French Academy’s disproof might have been rejected. (Laughter here.) But journals continue to make major goofs in publishing implausible results despite the popularity of a famous specialty journal for that purpose.

Examples vary from acceptance of language manipulation – “alternative,” “healing,” “integrative,” etc., to the fakery of recent papers showing effects of prayer. The two famous studies of prayer in the cardiac care unit ranged from the unadmitted breaking of the blind in the Bird study (So Med J 1988; 81:826-826) to unadmitted imbalances of subject and control groups (Harris, Arch Int Med 1999;159:2273-2278.) And from those to the likely fakery of the distant prayer study of in vitro fertilization (Cha, Wirth, Lobo; J Reprod Med 2001:46;781-786) in which three separate prayer groups on two continents improved pregnancy rates in a group of women on a third continent by an implausible 100 percent. In all of these cases, the papers passed peer or editorial review despite the methodological defects that were picked up by us skeptics (K. Atwood, K.Courcey [an RN] B. Flamm, and others.)

Adding insult to the above, Annals of Internal Medicine published a systematic review of intercessory prayer (Astin et al, Ann Int Med, 2000;132: 903-910) containing not only the Bird and Harris studies counted as positive, but also the Targ study on brain tumors, found by reporter Po Bronson to have had its end point altered by the authors when the primary one showed no effect.
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Posted in: Basic Science, Clinical Trials, Faith Healing & Spirituality, Health Fraud, Medical Academia, Science and Medicine, Vaccines

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More on the Bravewell issue

Being on the West Coast places me (and Harriet?) at disadvantage in responding to recent developments, as I find out about them later in the day, if that day. (Retirement doesn’t help.)

First I had some comments on the WSJ article on “CAM,” the NCCAM by Steve Salerno and the response by the pseudoscince leadership. The 4-author response revealed political tactics used by quacks and sectarian medicine advocates to answer with straw man points and especially to ignore what they cannot answer.

In their response to Salerno’s article they accused him of being unqualified to object to “CAM” because he was only a reporter. Fact was that most of his points were from my writings, which Slerno frankly acknowledged. The several rebutting authors never mentioned my name. Of course not. (That it was lost in the SBM analyses is understandable.)

And that is the frank dishonesty we are dealing with when we face off with these characters, who now have the ears and eyes of the Institute of Medicine, academic deans and professors, and government. They are smiling as they read this.
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Posted in: Basic Science, Health Fraud, Medical Academia, Politics and Regulation, Science and Medicine

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Probiotics

The Wall Street Journal has an assessment of Probiotics in the Jan 13, 2009 issue entitled Bug Crazy: Assessing the Benefits of Probiotics (1). For some reason when I wander around the hospital on rounds people show me articles such as this and ask, so whatcha think about this?

Probiotics are interesting. They are live bacteria given to treat and prevent diseases. It is one of those overlap areas for scientific medicine and so called alternative medicine. There are good clinical trials to suggest areas where these agents are of benefit, but other aspects of their use are blown out of proportion for the real or imagined benefit probiotics may provide. Much of alternative medicine where it overlaps with real medicine is the art of making therapeutic mountains out of clinical molehills.

The Wall Street Journal article is the kind of reporting that drives. me. nuts. It drive me nuts because the reporting acts as if the underlying assumptions of the therapies are true.

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Posted in: Basic Science, Science and Medicine, Science and the Media

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Our own slippery grounds

When we were forming the National Council against Health Fraud I wondered aloud to the president, Bill Jarvis, what we would do if society solved the chiropractic problem. Bill laughed and said there would never be an end to quackery claims.

How right he was. But why? Many express surprise that at this time of remarkable intellectual and scientific advance, so many people choose to believe in irrational medical claims. The answer I am used to is the one that explains the difference between the attraction of subjective versus the dryness of the objective; between reflex and conditioned responses and rational thought, and between immediate emotionally gratifying, low-level mid-brain reactions and slow-reacting, cool, higher level intellectual thought. These comparisons are all valid but in trying to answer the question, we can miss the constancy of human nature biology, the dimension of time flow, the changing nature of evidence, and as yet unemphasized, the changes and evolution of measurement.…

Before Evidence Based Medicine (EBM) was devised, and the randomized clinical trial (RCT) accepted as the so-called gold standard, our evidential decisions turned on balances or ratios of science/nonsense, rationality/irrationality, reality/delusion, and an estimate of plausibility/implausibility. We can see now that the concept of EBM introduced a new set of standards to our equations balances – proof by RCT and their derivatives, systematic reviews (SRs). The demand for proof by RCT and and SR relegated the previous standards, the unbalanced ratio concept, to the level of anecdote and “uncontrolled observation.” We had to start over again with a new standard.
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Posted in: Basic Science, Clinical Trials, Health Fraud, Science and Medicine

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Influenza Deaths

“There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don’t know. But there are also unknown unknowns. There are things we don’t know we don’t know.”- Donald Rumsfeld

How do we know what we know? It is said by some anti-vaccine proponents that vaccines are not needed because the diseases they prevent are either gone or no longer as severe as they were in pre vaccine times. People may have suffered and died in the distant past, but no longer. The risk now is from the vaccines not the diseases they no longer prevent.

36,000 people, more or less, die every year from influenza. That is the number of deaths according to the CDC web site; the NEJM review uses the higher number of 56,000 (7). Which number is correct? Isn’t that why the flu vaccine is recommended: to prevent all those people from dying.

36,000 is a lot of people. That’s about 120 deaths per million people in the US. In Oregon, population about 3 million, that would be about 360 people a year, which is two deaths a day for the six month flu season.

“Death is caused by swallowing small amounts of saliva over a long period of time.”–George Carlin.

2,400,000 people die every year in the US, about 6600 a day. In Oregon, that is about 65 deaths a day. No one outside a epidemiologist is going to notice 2 extra deaths a day during flu season. I have seen a lot of people die of influenza, but I have a biased experience: I am an infectious disease doc, so I am likely to see people with influenza, especially patients with disease severe enough to kill them.

About the same number of people die from car accidents and die from handguns in the US each year as die from influenza. I have never known a person in my real, as opposed to my professional, life to die from influenza or handguns or a car accident. My personal experience suggests no one dies from these causes, but since I take care of patients at one of the Portland trauma hospitals, I know what cars and guns do to people. My professional life confirms that people do indeed die from being shot or car accidents. I would wager that most people reading this blog have not known anyone who has died from influenza, guns or car accidents. The fact that people do die of influenza seems contradicted by experience. Why get the vaccine? I don’t get the flu and and no one I know has ever died from it.

As an illustrative example, a relative of mine, a retired physician, mentioned that he thought the shingles vaccine was a waste of time and money as he had never known anyone to get shingles. Using personal experience to judge disease prevalence is unreliable. If I applied the same rationale to driving, I would not wear a seat belt as I have never been in a high speed crash.

36,000 people die of influenza each year. What is the source of that statistic? From “Mortality associated with influenza and respiratory syncytial virus in the United States”. JAMA 2003. Is that really how many deaths are there from influenza? It depends on what you mean by ‘death’ and what you mean by ‘influenza’ and what you mean by ‘from’.

“It depends on what the meaning of the words ‘is’ is.” – Bill Clinton

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Posted in: Basic Science, Public Health, Vaccines

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Quackery tolerance – a learned response

Academic politeness turns to the vicious  This is more on the theme of academic and postmodern roots of sectarianism-quackery’s advance on medicine. I illustrate through the personal experience of a noted combatant – Mary Lefkowitz - in the front lines of the war with intellectual and academic buffoonery passing as scholarship. The joke is not in the buffoonery, though. The joke is turning on us.

Some of you are familiar with Prof.Lefkowitz’s academic dispute from publicity last spring. Prof. Lefkowitz is on the list of academic opponents to relativism and postmodernism. Lefkowitz’s travail began in 1993 when another Wellesley faculty member who led a department or course of Africana Studies claimed in lectures that ancient Greek and Roman intellectual advances were lifted from libraries and other sources of ancient Egypt, and that furthermore, those Egyptians were black Africans.

You recognize this as Afrocentrism, one of relativism and postmodernism’s multi-pronged attack on intellectualism and Western civilization. I attended a session on the problem in 1992 (or so) at the AAAS in San Francisco, and did not appreciate or understand what was going on, or why the raised rhetoric and voices. I do now, especially having read excerpts from Lefkowitz’s book, History Lesson, published earlier this year.
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Posted in: Basic Science, Medical Academia, Science and Medicine

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Vitamin C strikes (out) again

I didn’t think I’d be revisiting this topic again so soon. After all, I wrote one of my characteristic magnum opuses (opi?) less than two months ago, when I asked whether a recent animal study had vindicated Linus Pauling’s belief that high dose vitamin C is a highly effective cancer treatment. After that tsunami of verbiage that can only be exceeded by my fellow blogger Dr. Atwood when he’s on a roll doing a multipart deconstruction of some woo or other, I thought it would be best to give it a rest for a while. I guess less than two months will have to be enough.

The reason struck me as I was perusing the very latest issue of Cancer Research, hot off the presses October 1. As I did so, it didn’t take me long to come across an article from the Memorial-Sloan Kettering Cancer Center and the Herbert Irving Comprehensive Cancer Center at Columbia entitled Vitamin C Antagonizes the Cytotoxic Effects of Antineoplastic Drugs, whose first author is Dr. Mark Heaney.

Once more into the fray!
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Posted in: Basic Science, Cancer, Herbs & Supplements, Nutrition

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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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