Articles

Ultrasound Screening: Misleading the Public

There is a new industry offering preventive health screening services direct to the public. A few years ago it was common to see ads for whole body CT scan screening at free-standing CT centers. That fad sort of faded away after numerous organizations pointed out that there was considerable radiation involved and the dangers outweighed any potential benefits.

Now what I most commonly see are ads for ultrasound screening. In fact, I am sick and tired of finding them in my mailbox and between the pages of my local newspaper. Ultrasound is certainly safe, with no radiation exposure. It sounds like it might be a good idea, but it isn’t.

Life Line Screening advertises itself as “America’s leading provider of quality health screenings.” They offer “4 tests in less than 1 hour – tests that can save your life.” They travel around the country, setting up their equipment in community centers, churches, and YMCAs. For $129 you get ultrasounds of your carotid arteries, your abdominal aorta, your legs, and your heel bone. They mail you your results 21 days later. (more…)

Posted in: Health Fraud, Medical Ethics, Public Health

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Bad scientific arguments in the service of animal rights activism

One of the greatest threats to the preclinical research necessary for science-based medicine today is animal rights activism. The magnitude of the problem came to the forefront again last week with the news that animal rights terrorists tried to enter the home of a researcher at the University of California Santa Cruz (UCSC) whose research uses mice to study breast cancer and neurologic disease while she and her husband were having a birthday party for one of their children and assaulted her husband, who had gone to the front of the house to confront them. Fortunately, the license plate number of the car fleeing the scene was reported to police, leading to a raid on a house by police and the confiscation of computers and other materials. This attack appeared to be the latest crescendo in an increasing campaign of harrassment and intimidation by animal rights “activists” that has also been observed in nearby Berkeley.

This sort of threat to researchers is not a problem just in Santa Cruz and the Bay area, but in particular has been a problem in southern California as well. Just earlier this week, the University of California Los Angeles announced that it was suing several animal rights groups and individuals suspected of attacks on researchers who use animals, including UCLA Primate Freedom Project, the Animal Liberation Front (ALF), and the Animal Liberation Brigade (ALB), as well as several individuals believed to affiliate with these groups. The inciting event for this action was the second attack on the home of Edythe London, Professor of Psychiatry and Bio-behavioral Sciences and of Molecular and Medical Pharmacology at the David Geffen School of Medicine at UCLA, in early February. Her research involves the use of primate models to study nicotine addiction. In this most recent attack, an attempt was made to set her house on fire. This came on the heels of a previous attack in October, in which animal rights activists flooded her house. Prior to that, animal rights terrorists had indeed succeeded in their aim of intimidating a scientist sufficiently that he gave up animal research after a fellow researcher was targeted with a Molotov cocktail meant for her home that was mistakenly placed on the porch of an elderly neighbor. Also, we in the U.S. often forget how much more radical animal rights extremists are in the U.K., where the campaign of intimidation takes the form of death threats, intimidation of personnel of companies that supply researchers, and even in one case digging up the grave of Gladys Hammond, whose family ran a farm that raised Guinea pigs for use in medical research, and stealing her remains.

Readers may make the argument that my introduction to this discussion is unfairly inflammatory, but I have my reasons for starting this way, and I think they are good ones. First, make no mistake, the aim of the most radical of these activists is nothing short of the cessation of the use of all animals in biomedical research. Second, sooner or later, someone will be hurt or killed. As a researcher who on occasion uses mouse models of cancer myself, I state up front that I could be on the firing line just as much as the UCSC researcher or others and am justifiably disturbed when I hear spokesperson for the ALF Dr. Jerry Vlasak, for example, repeatedly advocate violence against researchers who use animals. In this article, I am not going to discuss the moral issues involved in animal research. What I am going to discuss is the seemingly scientific arguments that some opponents of animal research and animal rights activists like to invoke, arguments increasingly used in addition to the moral arguments that extremists use to justify their actions. If the arguments of opponents of animal rights research were indeed good science, then their appropriation by extremists would not allow me to do much other than bemoan the misuse of valid science as a justification for extremism. Unfortunately, such is not the case, and the bad scientific arguments used by opponents of animal research are often piled onto the extreme moral arguments that fuel actions such as those earlier this week at UCSC. Consequently, given the events of the last month or so, I thought I would take this opportunity to look at some of the common scientific indictments of animal research by its opponents.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation, Science and Medicine

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Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued Again

After the previous posting on the Bayesian approach to clinical trial data, several new comments made it clear to me that more needed to be said. This posting addresses those comments and adds a few more observations regarding the unfortunate consequences of EBM’s neglect of prior probability as it applies to “complementary and alternative medicine” (“CAM”).†

The “Galileo Gambit” and the Statistics Gambit

Reader durvit wrote:

A very interesting example, for a number of people, might be estimating the prior probability for Marshall and Warren’s early work on Helicobacter pylori and its impact on gastroduodenal management. I frequently have Marshall quoted to me as a variation on the Galileo gambit, so establishing whether he and Warren would have been helped or hindered by Bayesian techniques would be useful.

This suggestion raises a couple of issues. First, the “Galileo gambit” regarding Marshall and Warren’s discovery is a straw man (as durvit seems to have surmised). (more…)

Posted in: Homeopathy, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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A Foolish Consistency

A foolish consistency is the hobgoblin of little minds, adored by little statesmen and philosophers and divines.
— Ralph Waldo Emerson (1803–1882)

It is odd isn’t it? Large numbers of quality studies published in the best peer review journals consistently showing the same or similar effect and no contradictory studies. Despite the emphasis on evidence-based medicine, the entire literature is dismissed as not relevant because personal experience suggests that the studies are wrong.

Curiouser and Curiouser. Coherent arguments as to the validity and scope of the literature are met with denial but never a critique of the primary literature. The facts of the research are never argued. The only argument is personal experience or blanket denial. Despite the published literature, practice continues the same, untouched by the facts.

How can practitioners routinely deny a preponderance of evidenced-based medicine? What is a doc who believes in the primacy of evidenced-based practice to do but roll their eyes and think, as Bugs Bunny so memorably said, “What a maroon”.

I’m talking about acupuncture? Homeopathy? Therapeutic touch?

Nope.

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Posted in: Pharmaceuticals, Politics and Regulation

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Antiscience-Based Medicine in South Africa

South Africa’s Health Minister, Manto Tshabalala-Msimang, is fighting to protect the traditional healers of her country from having their methods tested scientifically. She warns that, “We cannot use Western models of protocols for research and development,” and that she does not want the incorporation of traditional healing to get “bogged down in clinical trials.” Her arguments are anti-scientific and represent a health tragedy for South Africa. However, such attitudes are not uncommon within the community of sectarian medicine and represent some of the common rhetoric used to disguise anti-scientific positions.

This is also not the first controversial statement made by South Africa’s health minister. In 2006 she advocated using garlic and beetroot to treat HIV infection, prompting outrage from South Africa’s academic community. In response to criticism about delays and funding cuts in providing anti-retroviral drugs to HIV sufferers in South Africa, the Health Minister said, “Garlic is absolutely critical, we need to do research on it. We cannot just ridicule it.” South Africa’s president, Thabo Mbeki, resisted calls for Ms. Tshabalala-Msimang’s resignation.

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Posted in: Politics and Regulation, Science and Medicine

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Glucosamine Update: A New Study and a New Product

ResearchBlogging.orgWhen I recently wrote about glucosamine, I discussed the evidence up through the New England Journal of Medicine study of 2006, which I thought was a pretty definitive study showing that neither glucosamine, chondroitin or a combination of the two was more effective than placebo.  Subsequent studies have continued to fuel the controversy. One 2007 study showed that glucosamine sulfate was better than placebo for knee osteoarthritis.  Another 2007 study showed that glucosamine HCl and chondroitin, with or without exercise, were no better than placebo for knee osteoarthritis. Sources like the Natural Medicines Comprehensive Database believe the evidence favors glucosamine sulfate but not glucosamine hydrochloride.

A new study was published 19 February 2008 in the prestigious Annals of Internal Medicine.  It is arguably the best study to date, and may shed some light on the controversy. Carried out in the Netherlands in a primary care setting, it studied 222 patients with hip osteoarthritis over a 2 year period. Half the patients took glucosamine sulfate 1500 mg a day; half took a placebo. They concluded that glucosamine sulfate was no better than placebo in reducing symptoms and progression of hip osteoarthritis. (more…)

Posted in: Clinical Trials, Herbs & Supplements

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When the popularity of new surgical procedures outpaces science

ResearchBlogging.orgIn science- and evidence-based medicine, the evaluation of surgical procedures represents a unique challenge that is truly qualitatively different from the challenges in medical specialties. Perhaps the most daunting of these challenges is that it is often either ethically unacceptable or logistically impossible to do the gold-standard clinical trial, a double-blind, randomized placebo trial for an operation. After all, the “placebo” in a surgical trial involves patients to anaesthesia, making an incision or incisions like the ones used for the operation under study, and then not doing the operation. Clearly, even leaving the ethics aside, it’s impossible to blind the surgeons and operative team involved to which treatment, real surgery or placebo, the patient is receiving without having a different surgeon do the surgery from the one overseeing the postoperative care of the patient, with the operative surgeon barred from communicating to the postoperative surgeon what happened in the operating room and from participating in the postoperative care of the patient upon whom he operated. This sort of restriction, besides being also highly dubious ethically speaking, goes against the grain of surgical culture, in which a surgeon is expected to provide the postoperative care for his patients almost as a matter of surgical honor. A final problem that complicates any surgical trial is that surgeons of differing technical operating skill will necessarily be involved, and surgical skill is indeed very important in determining outcome. Although there have been examples of double-blinded trials with sham surgery as placebo, for example, in injecting dopamine-producing cells into the brain to treat Parkinson’s disease, difficulties doing such studies tend to force us as surgeons in many cases either to rely on retrospective data, prospective non-randomized data, or, when we’re lucky, a prospective randomized (but not double-blinded) trial of one surgical procedure versus another.
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Posted in: Clinical Trials, Medical Ethics, Science and Medicine, Surgical Procedures

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Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued

This is an addendum to my previous entry on Bayesian statistics for clinical research.† After that posting, a few comments made it clear that I needed to add some words about estimating prior probabilities of therapeutic hypotheses. This is a huge topic that I will discuss briefly. In that, happily, I am abetted by my own ignorance. Thus I apologize in advance for simplistic or incomplete explanations. Also, when I mention misconceptions about either Bayesian or “frequentist” statistics, I am not doing so with particular readers in mind, even if certain comments may have triggered my thinking. I am quite willing to give readers credit for more insight into these issues than might be apparent from my own comments, which reflect common, initial difficulties in digesting the differences between the two inferential approaches. Those include my own difficulties, after years of assuming that the “frequentist” approach was both comprehensive and rational—while I had only a cursory understanding of it. That, I imagine, placed me well within two standard deviations of the mean level of statistical knowledge held by physicians in general.

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Posted in: Clinical Trials, Medical Academia, Science and Medicine

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Iraq civilian deaths II: Summing up

Call me naive, but I did not expect the volume or the emotional depth of the responses to the Iraqi civilian death post. I thought many would respond to the new NEJMed survey as I did; wondering about the validity of the previous surveys and recognizing that they have a validity problem. And, that there is a question about what is printed in major journals, from unexpected sources. I did not mean that studies such as Lancet II not be printed. I stated that it should not have been printed in a first line journal for the general medical public. It could have been printed in a 2nd or 3rd line specialty journal where its methods and conclusions could have been debated and reforms shaped by colleagues. I find that hints and clues to errors in pseudoscientific reports mostly lie in the methods section. But questioning a study’s validity can involve more than just a knowledge of the methods and recalculation of the data. Because the “CAM” movement has redefined the borders of the playing field as well as the rules of the game, the entire environment of the scientific system surrounding implausible or unusual reports has to be examined – this goes beyond limits of methods, and includes motivations, funding, characters, and subtexts.

In developing criteria for estimating plausibility (prior probability) the most important criterion of course is consistency and consilience with established knowledge. But there are more. One can increase the effectiveness of investigation by using indicators not presently included in “Evidence Based Medicine” or in science, but that are used in criminology (previous arrests, convictions,) business (trustworthiness, profit vs loss,) and ideology and politics (elevation of the trivial, manipulation of the system; example: sectarian medicine.)

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Posted in: Medical Ethics, Politics and Regulation, Public Health

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Proposed Changes to FDA Regulation Present a Dilemma

The Food and Drug Administration (FDA) is proposing a very interesting loosening of their regulations of pharmaceutical company marketing. The pros and cons of the proposed changes present an interesting dilemma, with legitimate points on both sides.

When the FDA approves a drug it is approved for a very specific medical indication. I have long thought that FDA approved indications for drugs were too narrow and restricting. For example, most anti-seizure medications are initially approved not for seizures but only for certain types of seizures – for example for adjunctive therapy (meaning it is meant to be added to another drug rather than used alone) for focal onset seizures (and not against primary generalized seizures – or ones that begin all over the brain at once).

Once approved physicians are free to use drugs as they see fit. If evidence shows that a new seizure medication is effective as first line treatment, then it is ethical good medicine to use it that way, even if it is not FDA approved for that use (this is called off-label use). FDA approved is not equivalent to science-based.

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Posted in: Pharmaceuticals, Politics and Regulation

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