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Archive for Politics and Regulation

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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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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The Iraqi Civilian War Dead Scandal

This is a story about a story and a story or two within that story. The first story is one of faulty epidemiology – data collection in a war zone. The first inside one is how medical news and journals affect not only national news, but are being used as political weaponry, to affect elections , and to change history.

Within that story is yet another – how editors contribute to fabrication, accepting or refusing to recognize fraud and misinformation. Yet another is that one cannot change some opinions, even after showing that the original information on which they were based was false. Sound familiar? We’ve been illustrating the point in classes for years.

The Iraq death studies. In 2004, weeks before the US presidential election, the journal, The Lancet published a study from a group at Johns Hopkins University, of Iraqi civilian deaths since the 2003 invasion (Lancet I). The results were unseemly high; a UN group estimated the deaths to be about one tenth of the Lancet’s report. The allied forces were still receiving approval for deposing Saddam Hussein, and the world press did not publicize them.

Then, 2-3 weeks before the 2006 US national congressional elections, with the Iraqi war wearing on and US and the world public tiring of stalemate and casualties, Lancet published a follow-up study (Lancet II) by the same group, concluding that in the years 2003-2006, Iraqi civilian war related deaths exceeded 600,000. It was shocking, made headline newspaper and television news. The study had such a significant impact partly because of where it appeared. The Lancet, despite its spotty record for off-beat articles, is revered by the public and the press. If the article’s publicity did not create a wave of political disapproval, it at least helped whip up the waves of discontent, washing in a major change in the Congress. Criticism of the study at the time seemed drowned out by its publicity. But a recent repeat study of civilian Iraqi deaths brings new light on the Lancet II study.

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Posted in: General, Politics and Regulation

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The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work

What’s an advocate of evidence- and science-based medicine to think about the National Center for Complementary and Alternative Medicine, better known by its abbrevation NCCAM? As I’ve pointed out before, I used to be somewhat of a supporter of NCCAM. I really did, back when I was more naïve and idealistic. Indeed, as I mentioned before, when I first read Wally Sampson’s article Why NCCAM should be defunded, I thought it a bit too strident and even rather close-minded. At the time, I thought that the best way to separate the wheat from the chaff was to apply the scientific method to the various “CAM” modalities and let the chips fall where they may.

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine. However, NCCAM cannot do otherwise, given its mission:

  • Explore complementary and alternative healing practices in the context of rigorous science.
  • Train complementary and alternative medicine researchers.
  • Disseminate authoritative information to the public and professionals.

If, in fact, NCCAM actually did devote itself solely to “rigorous science” with regard to “alternative” healing practices, I would have much less problem with it than I do. However, it broadly interprets the second and third parts of its mission. For example, it views part of its mission as promotion, rather than study: “Supporting integration of proven CAM therapies. Our research helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.” This would be all well and good if NCCAM had as yet actually proven any CAM therapies to be at least effective, but it has not. Worse, it has not even managed to demonstrate any of them to be ineffective, either, thus leading to endless studies of modalities that either do not work or at the very least would have marginal efficacy.

Still, I thought; All questions of promotion of CAM modalities aside, least there’s the science. Surely, under the auspices of the NIH, NCCAM must be funding some high-quality studies into CAM modalities that couldn’t be done any other way. That thought died when NCCAM announced last week the studies that it had funded during FY 2007.
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Posted in: Basic Science, Clinical Trials, Medical Academia, Politics and Regulation, Science and Medicine

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Collision of Incompatibles

Last week’s post was about a recent (October 2007) meeting held at Harvard University on the subject of fascia. The purposes for commenting were several.

First, the organizers were partial believers in some forms of “Complementary and Alternative Medicine” (“CAM”), now being called “Integrative” but more realistically called sectarian or anomalous, aberrant medicine. The meeting is another in a long series of associating sectarian medicines with science – a bad fit.

Second, it illustrated an increasing infiltration of sectarianism, ideological thinking, and pseudoscience into medical schools and academia.

Third, this infiltrating change is no natural evolution, but is a political and economically driven external force, intent on both selfish and ideological interest. The forces are intent on radically changing society with medicine as the point of their phalanx. They chose medicine because of its admitted openness and self-criticism (no trade secrets, no state secrets, no top secret clearances; its self-criticism is open for all to see.) A vulnerable and often willing victim.

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

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No-Touch Chiropractic

Some time ago, I learned that a Seattle chiropractor, Johanna Hoeller, had been featured on a local TV newsmagazine show. She was so proud of the segment that she had it posted on her web page for all to see. Unfortunately it is no longer there, so I’ll have to tell you what it showed.

She demonstrated her techniques on-camera. She put one wrist on top of the other, held them about an inch away from the patient’s neck and proceeded to produce a cracking sound in her own wrists without touching the patient in any way. The patient claimed to have felt something and to have experienced relief of pain.

The funniest part was when the news crew showed her their video of her performance and pointed out that she had not touched the patient. She appeared to be surprised and responded, “My whole thing is that I’m touching.”

Hoeller practices a form of chiropractic called NUCCA (National Upper Cervical Chiropractic Association). It’s a variant of the hole-in-one idea first proposed by B.J. Palmer, the son of the inventor of chiropractic, D.D. Palmer. Supposedly if you adjust the top cervical vertebra, that will correct any problems in the entire spinal column. Fix one and you fix them all. There is no credible evidence for any of NUCCA’s claims.

So here’s a woman “pretending” to do something that doesn’t work even if you actually “do” it. A little knowledge of psychology easily explains why she has so many satisfied patients. It’s even easy to understand how her experiences may have genuinely convinced her she is doing something effective. What I have trouble imagining is how she first got the idea to try treating without touching in the first place! (more…)

Posted in: Chiropractic, Politics and Regulation

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