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Archive for Politics and Regulation

Charlatan: Quackery Then and Now

Charlatan: America’s Most Dangerous Huckster, the Man Who Pursued Him, and the Age of Flimflam, by Pope Brock, is not only a rip-roaring good read, but it brings up serious issues about regulation of medical practice and prosecution of quackery. It tells the story of John R. Brinkley MD, who transplanted goat glands into people, and of Morris Fishbein MD, the editor of the Journal of the American Medical Association, who tried to stop him.

The Charlatan

Brinkley was a colorful character whose very first job was a scam, selling a patent remedy. He went to medical school but never finished, eventually buying a diploma elsewhere for $100. A bigamist, drunkard, liar, and con man of incredible audacity, he built up an empire of quackery that made him filthy rich. Apart from his medical adventures, he practically invented modern political campaigning techniques, revolutionized advertising, and was almost single-handedly responsible for popularizing country music and the blues with his radio station.

An impotent patient supposedly told Brinkley, “Too bad I don’t have goat nuts.” So Brinkley gave him some. A few weeks later he went back for a refresher course in surgery (which he failed because of drunkenness and poor attendance). He began to feel that he was gifted and should not be bound by the “jealous sheep ethics” of the AMA. (more…)

Posted in: Book & movie reviews, Health Fraud, Politics and Regulation

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The Ethics of “CAM” Trials: Gonzo (Part III)

A Reminder (Mainly to Myself): this Blog will Eventually get back to Discussing the NIH Trial of the “Gonzalez Regimen” for Treating Cancer of the Pancreas†

Which, if you’ll recall, is an arduous dietary and “detox” regimen that includes 150 pills per day, many of which contain pancreatic enzymes, two “coffee enemas” per day, ”a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest,” and more. In Part II I ventured off on a tangent about Laetrile and government sponsorship of trials of implausible cancer “cures.” That became more involved than I had planned (but also more enlightening, or so I hope), and Part III continues on that tangent.

The Politics of “Alternative Cancer Treatments”: the Lamentable Legacy of Laetrile (cont.)

The whole tide is beginning to turn toward metabolic therapy for degenerative disease and preventive medicine. Laetrile…has been the battering ram that is dragging right along with it…B-15,…acupuncture, kinesiology, …homeopathy and chiropractic…And we’ve done it all by making Laetrile a political issue.”

-Michael Culbert, editor of The Choice, the newsletter of the Committee for Freedom of Choice in Medicine. Quoted in 1979.¹

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

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The Weekly Waluation of the Weasel Words of Woo #3

Last Week’s Entry: Everyone’s a Winner!

The resounding total of 4 “translations” for the second W^5 entry might have been trying to tell me something…nah!

I gotta say that each of the four nailed the central point: the esteemed Institute of Medicine (IOM), a subset of the esteemed National Academy of Sciences, has decided that it’s just fine—no, it is “important” and even “required”—that when it comes to “CAM,” the medical profession dispense with ethics, law, and science. Otherwise we might mistakenly argue, er, against the “integration of CAM therapies with conventional medicine.” That, clearly, would be unacceptable.

Stephen Barrett and others have critiqued some of remainder of the text. Regarding our own group of translators: yeah, you are all winners, but Stu once again rose above the crowd. Whadizzy, some kinda ringer? If he keeps this up I might have to insist that he be tested for performance-enhancing substances.

Hoodathunk that the IOM’s opinions are for sale? They are: the language that you deconstructed was bought and paid for, as we clunky Americans are so fond of saying, by…you and me! Yup, our tax dollars, funneled through the NCCAM and some other government agencies, generated the very Pap that we Smeared.

This Week’s Entry

In order to encourage more participation, I’ll try limiting entries to a single paragraph each, for a while anyway. This week’s entry, which will be the first of several from the same treatise, is found on the website of the American Medical Student Association (AMSA) as part of its “CAM Education Initiative“:

EDCAM – CAM and Medical Education Report

Medicine today is experiencing a paradigm shift that involves the blending of two disparate philosophies of health and disease, the biomedical or scientific reductionist view and the clinical, experiential holistic view. While the biomedical model reduces disease to a disturbance in biochemical processes and relies heavily on the “curative model” of care, holistic medicine derives from a “healing model,” which emphasizes the complex interplay between multiple factors: biochemical, environmental, psychological, and spiritual.

Feel free not only to restate it in the Queen’s English (it’s already in the Prince’s), but to comment upon its assertions. Remember, you gotta week, and I’ll announce the lucky winners in 2 weeks.

Happy waluating!

The Misleading Language and Weekly Waluation of the Weasel Words of Woo series:

  1. Lies, Damned Lies, and ‘Integrative Medicine’
  2. Integrative Medicine: “Patient-Centered Care” is the new Medical Paternalism

Posted in: Humor, Medical Academia, Politics and Regulation

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The Ethics of “CAM” Trials: Gonzo (Part II)

Laetrile and the Politics of NIH-Sponsored trials of “Alternative Cancer Treatments”

Part I of this blog ended by asking how, in light of the implausible and arduous nature of the “Gonzalez regimen” for cancer of the pancreas, and the unconvincing “best case series,” the NIH could ever have decided to fund a trial of it.† This entry will begin to answer that question. In so doing it may seem to veer from the original subject, but hold on to your seats: what you’ll find here is a piece of the treasure map that leads to the Mother Lode of Fool’s Gold that is government-sponsored “CAM” research.

All historical accounts of the encroachment of implausible claims into the research agenda of the NIH must begin with Laetrile. By that is meant all implausible claims, not merely those having to do with cancer. Elsewhere we have traced the history of “chelation therapy” for coronary artery disease, and have shown that its origins as a political movement, eventually leading to an unethical, $30 million, 2000 subject NIH trial, were intimately associated with people and organizations advocating Laetrile—the most lucrative health fraud ever perpetrated in the United States. In that essay we offer evidence that the creation of the NCCAM itself was at least partly attributable to the history of Laetrile and its advocates. Several good histories or partial histories of the Laetrile debacle are available online, including here, here, here, here, here, and here. The best,¹ but one that does not seem to be available online, is by the recently deceased dean of historians of American quackery, James Harvey Young. (more…)

Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Politics and Regulation

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The Ethics of “CAM” Trials: Gonzo (Part I)

Blogger’s note: This blog, which is rough going in places, will be presented in either 2 or 3 parts (I won’t know which until next week). I’ll post a part each week until it is complete, but due to overwhelming popular demand I promise to maintain the every-other-week posting of the far more amusing Weekly Waluation of the Weasel Words of Woo/2.

Introduction

On Feb. 25, 2008, the federal Office for Human Research Protections (OHRP) cited Columbia University Medical Center (CUMC) for violating Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects (45CFR§46). The violations involved Columbia’s administration of the NIH-sponsored trial of the bizarre “Gonzalez Regimen” for treating cancer of the pancreas.† The OHRP’s determination letter to Steven Shea, MD, the Director of the Division of General Medicine and Senior Vice-Dean at CUMC, cited ethical problems of a serious kind:

We determine that the informed consent for the 40 of 62 subjects referenced by CUMC was not documented prior to the start of research activities, nor was the requirement for documentation waived by the CUMC IRB for subjects in this study.

It was the second time that the OHRP had cited Columbia for its dubious management of the “Gonzalez” trial. The first occurred in Dec. 2002, after investigators had determined that the trial’s consent form “did not list the risk of death from coffee enemas.” The OHRP listed several other violations at that time, but “redacted” them from the letter that it made available to the public. (more…)

Posted in: Cancer, Clinical Trials, Health Fraud, Medical Ethics, Politics and Regulation

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Where Are We Going?

Where is it all headed? Medicine on another threshold. Allow me to present several previously unconnected news articles that illuminate the serious problem we face in today’s increasingly scientifically rootless world.

Who are scientific medicine’s friends; on whom can we rely for support of reason and common sense, unbiased approaches to funding, unbiased efficacy evaluation, fair law enforcement, and a return to the logical world of decades ago? The private insurance industry is taking it in the gut, while Pharma receives the repeated jabs. Corrupt administrations run off with hundreds of millions, inadequately punished for the degree of misbehavior. Academicians, no longer squeaky clean, unwilling to keep house on big-money grant recipients while tolerating massive private consulting fees. Schools infiltrated by mindless relativism satisfy the lowest academic levels despite the revolutionary changes in biology and massive knowledge base new MDs have to apply.

Just in 2 weeks a number of seemingly unrelated developments in the news got one to thinkin’, …there aren’t any to trust anymore. The government agencies are just as bad. Start with the FDA. Steve Barrett’s Consumer Health Digest Quackwatch.com has been trying to reassess the status of one or more quackery proponents and practitioners. One of his routes is the examination of FDA records of enforcement and warning letters to violators. From CHD of 3/11/08:

FDA “hides” old warning letters. The FDA Web site has made several changes that greatly decrease the visibility of warning letters about products and safety violations. Letters issued before January 2007 have been moved into a new directory so that all incoming links to them from other sites have been broken. This directory is also coded so that search engines cannot index its contents. Searching for warning letters on the FDA site is difficult because (a) the newer and older letters have to be searched separately, (b) the search page for pre-2007 pages in not easy to find. (c) letters are moved to the archive folder at irregular intervals, and (d) many of the older letters are in PDF format, which means that they will be found only if the searcher uses specific keywords. The agency as become extremely slow in responding to Freedom of Information Act requests. In August 2005, Dr. Barrett asked for a document related to a warning letter. If one exists, finding it would take only a few minutes. Barrett’s Congressman has asked twice for the document, and FDA staff members have phoned Barrett four times during the past year to find out whether he still wants it. But it still has not come. Bloomberg News has reported that in May 2007, the agency had 20,365 unfilled requests, including 1,924 that were more than three years old and that the the number of workers filling requests has been cut even though the backlog had been steadily rising. [Blum J. (more…)

Posted in: Politics and Regulation, Science and Medicine, Vaccines

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Misleading Language: the Common Currency of “CAM” Characterizations. Part I

The Best Policy

From time to time I have been reiterating that correct use of the language has much to do with logic; I should add that it entails also honesty. I use the word “honesty” in its broadest sense…

Concision is honesty, honesty concision—that’s one thing you need to know.

—John Simon. Paradigms Lost: Reflections on Literacy and its Decline. New York, NY: Clarkson N. Potter, Inc.;1980. pp. 48, 52

Prologue

In 1983, a naturopath in Alberta inserted balloons into the nostrils of a 20 month-old girl and inflated them. The child died of asphyxiation. Subsequently, a judge described the treatment—dubbed “bilateral nasal specific” by the chiropractor who had invented it—as “outright quackery.” [1] Fast-forward 15 years: a woman presented to the otolaryngology clinic at the University of Washington in Seattle “complaining of severe midface pain and epistaxis” (nosebleed). She had suffered nasal septal fractures caused by a similar treatment, by then renamed “NeuroCranial Restructuring” (NCR). In their case report, the surgeons who had treated the woman at U. Wash discussed the claims of NCR and explained that the relevant anatomy predicts that it is implausible and risky. They also reported that it is expensive: “$2000 to $4800 for a standard course (of 4 treatments).” They concluded:

This case report of a complication after a CAM procedure called NCR highlights the wide range of treatment options available to patients. It is important for otolaryngologists to be aware of the spectrum of CAM therapies that patients may pursue and be aware of potential complications from these procedures.

An accompanying editorial used similar language.

How is it that in 1983 a judge could offer a concise summary of the essence of such a method, whereas scarcely a generation later 5 highly-trained medical doctors, even after presenting the sordid facts, could only obscure it with bland euphemism? (more…)

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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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