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Woosceptibility: A Brief Interview With James Randi

James Randi, perhaps better known as “The Amazing Randi” has spent most of his life performing magic shows. In 1996 he created the James Randi Educational Foundation (JREF) designed to expose the fraudulent claims made by psychics, faith healers, and snake oil salesmen. The ultimate goal of the JREF is to create a new generation of critical thinkers – people who will not be hoodwinked by the aforementioned hucksters.I had the good fortune of interviewing Mr. Randi briefly at the recent conference known as “The Amazing Meeting.” I was eager to pick his brain about human behavior and magical thinking. This is what I learned…

Randi identified certain groups of people who seem to be more susceptible to magical thinking and/or belief in the paranormal. According to him, the top two are:

1. News reporters. Although at first I wasn’t sure if Randi meant that reporters like a good story versus they believe a good story – he told me that in his experience, they were some of the most gullible people on earth. In fact, they were more interested in implausible stories than true ones – and Randi said that the more fantastical his explanation for phenomena, the more likely they were to believe it and write about it.

2. Academics. This surprised me since I assumed that this group would actually be less susceptible. Randi suggested that they are more likely to be taken in because they are single-minded about phenomena. They are over confident in their ability to understand how things work, and when something cannot be explained in their framework, they’re willing to attribute it to the paranormal.

Who are the least susceptible? Children. Why? Because they are simple thinkers, and harder to distract. The art of magic is in distraction of the sophisticated mind. Children tend to be very concrete, so they don’t expect things to happen with hand-waving and flourishes. They keep their eye on the coin (or other item being transferred from hand to hand), and are more likely to know where it is at all times.

To wrap up our short interview, I asked Randi if he could explain why people believe in magic, fantasy, and the paranormal? He responded plainly:

Ultimately it’s not about intelligence or lack thereof. It’s about people not wanting to accept that life is random, suffering is inevitable, and there is no good reason for bad things happening.

What do you make of Randi’s observations?

Posted in: Faith Healing & Spirituality, Health Fraud, Neuroscience/Mental Health

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NIH Awards $30 Million Research Dollars To Convicted Felons: Cliff’s Notes Version

In case you’re coming late to this discussion (or have ADD), I’ve summarized Dr. Kimball Atwood’s terrific analysis of the ongoing clinical trial (TACT trial) in which convicted felons were awarded $30 million by the NIH.

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In one of the most unethical clinical trial debacles of our time, the NIH approved a research study (called the TACT Trial – Trial to Assess Chelation Therapy – a supposed treatment for arteriosclerosis) in which the treatment had no evidence for potential benefit, and clear evidence of potential harm – and even the risk of death. Amazingly, the researchers neglected to mention this risk in their informed consent document. The NIH awarded $30 million of our tax dollars to ~100 researchers to enroll 2000 patients in this risky study (ongoing from 2003-present). Even more astounding is the fact that several of the researchers have been disciplined for substandard practices by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons.

But wait, there’s more.

The treatment under investigation, IV injection of Na2EDTA, is specifically contraindicated for “generalized arteriosclerosis” by the FDA. There have been over 30 reported cases of accidental death caused by the administration of this drug – and prior to the TACT, 4 RCTs and several substudies of chelation for either CAD or PVD, involving 285 subjects, had been reported. None found chelation superior to placebo.

So, Why Was This Study Approved?

The NIH and the TACT principal investigator (PI) argued that there was a substantial demand for chelation, creating a “public health imperative” to perform a large trial as soon as possible. In reality, the number of people using the therapy was only a small fraction of what the PI reported.

It’s hard to know exactly what happened “behind the scenes” to pressure NIH to go forward with the study – however a few things are clear: 1) the National Heart, Lung, and Blood Institute (NHLBI) initially declined to approve the study based on lack of scientific merit 2) congressman Dan Burton and at least one of his staffers (Beth Clay) and a lobbyist (Bill Chatfield) worked tirelessly to get the study approved through a different institute – NCCAM 3) some of the evidence used to support the trial was falsified (The RFA cited several articles by Edward McDonagh, the chelationist who had previously admitted in a court of law to having falsified his data.) 4) The NIH Special Emphasis Panel that approved the TACT protocol included L. Terry Chappell, whom the protocol had named as a participant in the TACT.

All evidence seems to suggest that political meddling managed to trump science in this case – putting the lives of 2000 study subjects at risk, without any likely benefit to them or medicine.

A formal analysis of the sordid history and ethical violations of the TACT trial was published by the Medscape Journal of Medicine on May 13, 2008. Atwood et al. provide a rigorous, 9-part commentary with 326 references in review of the case. Congressman Burton’s staffer, Beth Clay, published what is essentially a character assassination of Dr. Atwood in response.

The NIH Writes TACT Investigators a Strongly Worded Letter

On May 27, 2009 the Office for Human Research Protections Committee sent a letter to the investigators of TACT, stating that they found, “multiple instances of substandard practices, insurance fraud, and felony activity on the part of the investigators.” The letter describes a list of irregularities and recommends various changes to the research protocol.

It is almost unheard of for a letter from the NIH to state that research study investigators are guilty of fraud and felony activity – but what I don’t understand is why they haven’t shut down the study. Perhaps this is their first step towards that goal? Let’s hope so.

Conclusion

The TACT trial has subjected 2000 unwary subjects and $30 million of public money to an unethical trial of a dubious treatment that, had it been accurately represented and judged by the usual criteria, would certainly have been disqualified. Political meddling in health and medical affairs is dangerous business, and must be opposed as strongly as possible. Congressmen like Tom Harkin and Dan Burton should not be allowed to push their political agendas and requests for publicly funded pseudoscience on the NIH. I can only hope that the new NIH director will have the courage to fend off demands for unethical trials from political appointees.

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

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How do scientists become cranks and doctors quacks?

As a physician and scientists who’s dedicated his life to the application of science to the development of better medical treatments, I’ve often wondered how formerly admired scientists and physicians fall into pseudoscience or even generate into out-and-out cranks. Examples are numerous and depressing to contemplate. For example, there’s Linus Pauling, a highly respected chemist and Nobel Laureate, who in his later years became convinced that high dose vitamin C could cure cancer. Indeed, Pauling’s belief that high dose vitamin C could cure the common cold and cancer fueled the development of a whole new form of quackery known as “orthomolecular medicine,” whose entire philosophy seems to be based on the concept that if some vitamins are good more must be better. In essence, “orthomolecular medicine” is a parody of nutritional science; indeed, its advocates take credit for how some strains of “complementary and alternative medicine” (CAM) so frequently advocate the ingestion of huge amounts of dietary “supplements.” I could even go farther and say that orthomolecular medicine is clearly a major part of the “intellectual” (and I do use that term loosely) underpinning of the various biomedical treatments for autism that Jenny McCarthy and Generation Rescue advcoate.

There are other examples as well, all just as depressing to contemplate. For example, consider Peter Duesberg, a brilliant virologist who in the 1980s was widely believed to be on track for a Nobel Prize; that is, until he became fixated on the idea that HIV does not cause AIDS. True, lately he’s been trying to resurrect his scientific reputation with his interesting and possibly even promising chromosomal aneuploidy hypothesis of cancer, but, alas, true to form he’s been doing it by acting like a crank. Specifically, he sees his hypothesis as The One True Cause of Cancer and disparages conventional thinking as having been so very, very wrong all these years (with his being, of course, so very, very brilliant that he saw what no one else could see). Then there are people like Dr. Lorraine Day, who was a respected academic orthopedic surgeon in the 1980s. In the late 1980s, she started to flirt with AIDS pseudoscience through a scare campaign about catching AIDS from aerosolized blood. Of course, given the mystery and fear over HIV in the early years of the epidemic, such a fear, although overblown, was not so far out of the mainstream as to be worthy of the appellation crank. However, after being diagnosed with breast cancer, unfortunately Dr. Day rapidly degenerated into a purveyor of rank pseudoscience, as well as a New World Order conspiracy theorist, religious loon, and Holocaust denier. And let’s not forget Mark Geier, who, although not a distinguished scientist, did, before his conversion to antivaccinationism, apparently do a real fellowship at the NIH and appeared to be on track to a respectable, maybe even impressive, career as an academic physician. Now he’s doing “research” in his basement, injecting autistic children with a powerful anti-sex hormone drug and abusing epidemiology. There are innumerable other examples.
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Posted in: Clinical Trials, Health Fraud, Science and Medicine

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Politics as Ususal

POLITICS. We have a tacit understanding to exclude politics from the blog, but current events are pushing the borders.  It’s not our fault, other forces are on the move. At the border last year was the Iraqi civilian body count issue precipitated by articles in The Lancet. That’s when politics intrudes into medical research and literature.

Other borders are matters of licensure, and of permitted and rejected methods and materials, encoded into licensure, food and drug laws, and a myriad of administrative edicts and court decisions.  One can’t escape the politics of those, especially when Congress and states start to control as commercial entities, areas that historically belong in culture: professional behavior codes, codes of traditional relationships between physicians and patients, for instance. These are under further pressures of conformity and legal sanctions enforced by the power of central government.

Steve  Salerno (web site: www.journalismpro.com, blog: www.shamblog.com), author of the WSJ article on “CAM” and the NCCAM last December that precipitated the Chopra, and Co. responses, brought to attention a recent House hearing at which Congr. Riley (D, Ohio) queried Sec. Sibelius whether she was aware of “mindful meditation” as a cost-saving method that should be included in any federal health plan.

Here we go again. Ten to 15 years ago it was Sen. Harkin legislating research and practice from halls of Congress resulting in the Office of Alternative Medicine and NCCAM. That legislation resulted in financed medical school courses, multiple more lectures and demonstrations, and now med school divisions with endowed chairs, scores to hundreds of employed associates, and with little to no scientific feedback or oversight.
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Posted in: Health Fraud, Politics and Regulation, Science and the Media

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Chemical castration for autism: After three years, the mainstream media finally notices

We’ve written a lot about anti-vaccine zealotry on this blog, as Steve and I take a particular interest in this particular form of dangerous pseudoscience for a number of reasons. One reason, of course, is that the activities of antivaccine groups like Generation Rescue and its spokesmodel since 2007 (Jenny McCarthy, a frequent topic on this blog) have started to frighten parents about vaccines enough that vaccination rates are falling well below that required for herd immunity in some parts of the country. Indeed, McCarthy, at the behest of her handlers in Generation Rescue, serves up a regular “toxic” brew of misinformation and nonsense about vaccines, most recently in a video that was the subject of a post by Val Jones about her unbelievably pseudoscience-laden blather. Truly, it has to be seen to be believed. Meanwhile, Generation Rescue has sent McCarthy on a media propaganda tour for her latest antivaccine pro-quackery book and set up a misinformation-laden propaganda site called Fourteen Studies (blogged about by Steve Novella, Mark Crislip, and, of course, yours truly) in which they attack well-designed studies that have failed to confirm their pet idea that somehow, some way, vaccines must be the cause of autism. And, when their pseudoscience is criticized, the antivaccine movement has a tendency to launch vicious ad hominem attacks, as they recently did against Steve Novella and have done multiple times in the past against me.

However, there is one other consequence of the antivaccine movement, however, and it is at least as important as the public health implications of the potential dimunition of herd immunity caused by the fear mongering of groups like Generation Rescue. That consequence is the cottage industry of “biomedical” treatments to which desperate parents subject their children. Gluten-free diets, chelation therapy (which has caused deaths), hyperbaric oxygen chambers (a recent story described a child getting severely burned when one of these caught fire), autistic children have been subjected to it all. But of all the biomedical woo to which autistic children have been subjected, one form of woo stands out as being particularly heinous. Indeed, I agree with our fearless leader Steve in characterizing it as an “atrocity.”

I’m referring to Mark and David Geier’s favored “treatment” for autistic children, namely a drug called Lupron.
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Posted in: Clinical Trials, Health Fraud, Medical Ethics, Neuroscience/Mental Health, Politics and Regulation, Public Health, Science and the Media, Vaccines

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Raw deal: Got diarrhea?

I recently saw a 14 year old girl in my office with a 2 day history of severe abdominal cramps, bloody diarrhea, and fever. Her mother had similar symptoms as did several other members of her household and some family friends. After considerable discomfort, everyone recovered within a few days. The child’s stool culture grew a bacterium called Campylobacter.

Campylobacter is a nasty little pathogen which causes illness like that seen in my patient, but can also cause more severe disease. It is found commonly in both wild and domestic animals. But where did all these friends and family members get their campylobacter infections? Why, from their friendly farmer, of course!

My patient’s family and friends had taken a weekend pilgrimage to a family-run farm in Buck’s County, Pennsylvania. They saw farm animals and a working farm. And they all drank raw milk. Why raw milk? Because, as they were told and led to believe, raw milk is better. Better tasting and better for you.

In 1862, the french chemist Louis Pasteur discovered that heating wine to just below its boiling point could prevent spoilage. Now this process (known as pasteurization) is used to reduce the number of dangerous infectious organisms in many products, prolonging shelf life and preventing serious illness and death. But a growing trend toward more natural foods and eating habits has led to an interest in unpasteurized foods such as milk and cheese. In addition to superior taste, many claim that raw milk products provide health benefits not found in the adulterated versions. Claims made about the “good bacteria” (like Lactobacillus) conquering the “bad” bacteria (like Campylobacter, Salmonella, and E. coli) in raw milk are pure fantasy. Some even claim that the drinking of mass-produced, pasteurized milk has resulted in an increase in allergies, heart disease, cancer, and a variety of other diseases. Again, this lacks any scientific crediblity.
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Posted in: Health Fraud, Nutrition, Public Health, Science and Medicine

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Flu Woo Hodge Podge

Perhaps you have discovered for yourself that I am always the last to write a post on a ‘hot’ topic. I am definitely the slowest writer (and thinker?) on this blog, starting each post at least a week before it is up. So the faster writers weigh in first and I am left with clean up.

As I finish writing on Thursday, there have been 892 cases of H1N1 aka Swine flu and 2 deaths in the US. Looks like the world has avoided a disastrous pandemic like the 1919 flu that killed off 2 to 5% of the world. For now. Maybe. I hope.

However, the flood of nonsense about the flu far exceeds the infection rates from H1N1. This entry will be the limited by necessity. The quantity of quackery (9) far exceeds my ability to type. I thought that influenza virus replicated and spread fast. It pales next to the flu woo.
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Posted in: Health Fraud, Homeopathy, Public Health, Science and Medicine, Science and the Media

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The Huffington Post‘s War on Medical Science: A Brief History

I realize that our fearless leader Steve Novella has already written about this topic twice. He has, as usual, done a bang-up job of describing how Arianna Huffington’s political news blog has become a haven for quackery, even going so far as to entitle his followup post The Huffington Post’s War on Science. And he’s absolutely right. The Huffington Post has waged a war on science, at least a war on science-based medicine, ever since its inception, a mere two weeks after which it was first noticed that anti-vaccine lunacy ruled the roost there. Because I’ve had experience with this topic since 2005, I thought I’d try to put some perspective on the issue, in order to show you just how pervasive pseudoscience has been (and for how long) at the blog whose name is often abbreviated as “HuffPo.”
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Posted in: Cancer, Health Fraud, Herbs & Supplements, Homeopathy, Politics and Regulation, Science and the Media, Vaccines

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Homeocracy II

ResearchBlogging.orgThis is the second installment analysis of a three (and now 4) part series of articles on effects of homeopathy on childhood diarrhea. This second installment elaborates on our findings on data from the second clinical trial in Nicaragua. (1)

I should first explain the title. In order for homeopathy to operate as a base or operating system for medicine “for the 21st century,” the entire system of measurement and of course all physical laws would have to be changed. In analogous political terms, it would be similar to – but more massive a change than – changing a nation from a democracy to a completely different system such as a theocracy with completely different laws and behavior expectations. So…well, it was the best I could think up at the time.

Last time I recounted how the Jacobs ll trial setup was incoherent and unable to produce  results that could prove efficacy – unless the differences between treatment and controls were quite large,  greater than just barely significant. Most patients were treated differently from others, with multiple preparations (that were in reality the same: pill filler) at differing times during the illness, with each preparation selected according to symptoms that likely varied by the hour, and influenced by memory, well known to be faulty in medical studies.

In fact, given the lack of homogeneity in the trial diagnoses and treatments, outcomes should not have made sense at all.  Now I must admit that the thought did not occur to us at the time we undertook the review, nor during the review. If it had, our job would have been easier and the paper shorter.
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Posted in: Clinical Trials, Health Fraud, Homeopathy, Science and Medicine

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Harvard Medical School: Veritas for Sale (Part V)

September 26, 2002

Kimball Atwood, M.D.
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Dear Kim,

I have now had time to look into the allegations in your letter of June 14th which, incidentally, I shared with Dr. David Eisenberg and he with several others. I have sought consultation about our exchanges and the gist of my response follows.

Some of your concerns and allegations are very helpful and constructive. Perceptions are particularly important in controversial fields where there is limited objective proof. Your cautions and interpretations in this area have been very useful to us.

Some of what you said is just plain wrong. This includes the allegation the Harvard has “a stake” in the area and therefore would not look into your allegations objectively. Relatedly, Dr. Howard Koh has written us a construction of the events in the Massachusetts Special Commission that is strikingly different from yours. And Dr. Anthony Komoroff has pointed out that many of your comments about the InteliHealth treatment of CAM are now grossly out of date as the material inherited from another provider has been reviewed by HMS faculty and modified. [Indeed, you have referred in other correspondence to modifications you have noticed.] Dr. Komaroff also commented on the misleading way your citation the treatment of homeopathy was disconnected from the rest of the paragraph.

Some of what you said is a matter of taste or interpretation, where even well intentioned people may disagree. In this particular area I have weighed your arguments carefully and, in places, learned from them.

But I think the biggest difference may be in a misperception about what our purposes are. The Council of Academic Deans of Harvard Medical School approved beginning a Division of Research and Education in Complementary and Alternative Therapies with exactly the focus described. Our goal is to do peer-reviewed basic and clinical research on the claimed, but unproven, efficacies of complementary and alternative approaches to therapeutics. The recent scientific sessions and requests for proposal held by the Division are clear testament to this intent. In addition, in common with the Association of American Medical Colleges and most of the allopathic schools of medicine, we intend to teach our students something about CAM and in particular how to assess its claims rigorously. We do not, repeat NOT, have any intention of making our students CAM practitioners. They have enough to do learning what we have always focused on.

Sincerely,

Daniel D. Federman, M.D.

cc: David M. Eisenberg, M.D.

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Posted in: Health Fraud, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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