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Posts Tagged Chelation Therapy

“Alternative” cancer cures in 1979: How little things have changed

Sometimes blogging topics arise from the strangest places. It’s true. For instance, although references to how tobacco causes cancer and the decades long denialist campaign by tobacco companies are not infrequently referenced in my blogging (particularly from supporters of highly dubious studies alleging a link between cell phone radiation and cancer and the ham-handed misuse of the analogy by antivaccinationists, who seem to think that vaccine companies engage in deceit on a scale similar to the deceptive practices of tobacco companies in “denying” that vaccines cause autism and all the other conditions, diseases, and horrors their fevered imaginations attribute to them), I’ve never really delved particularly deeply into one of the most useful repositories of documents on the topic that exists, namely the UCSF Legacy Tobacco Documents Library. Actually, the reason I started poking around there is not due to tobacco science, but because a fellow blogger mentioned to me that there were some articles and documents about Stanislaw Burzynski there dating back to the late 1970s. My curiosity was piqued.

As I explored, however, I learned that the documents there were not so much about Stanislaw Burzynski per se. In fact, they were more about the state of the underground “alternative cancer cures” industry in the late 1970s, which interested me greatly. The reason is that, when it comes to having delved so deeply into cancer quackery, I’m a relative newbie. Compared to, for example, Wally Sampson, Stephen Barrett, Peter Moran, or even Kimball Atwood, I’m inexperienced, having only noticed this phenomenon in a big way in the Usenet newsgroup misc.health.alternative back around 2001 or so, give or take a year. As a result, I don’t have the shared historical perspective that they do, mainly because I can only learn about that era from reading, studying, and talking to people who were active then. After all, in the late 1970s I was still in high school, and in the 1980s I was in college and medical school. There was no Internet (at least none that I had access to and that contained the wealth of easily accessible information to which we have become accustomed). In any case, in high school I had other interests, and throughout the 1980s I was too focused on getting an education and training to be a surgeon and researcher, a process that extended into the late 1990s. (Yes, it takes that long sometimes, particularly if you are masochistic enough to want to get a PhD, complete a general surgery residency, and do a fellowship in surgical oncology.)
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Posted in: Cancer, Health Fraud, History

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The result of the Trial to Assess Chelation Therapy (TACT): As underwhelming as expected

Chelation therapy.

It’s one of the most common quackeries out there, used by a wide variety of practitioners for a wide variety of ailments blamed on “heavy metal toxicity.” Chelation therapy, which involves using chemicals that can bind to the metal ions and allow them to be excreted by the kidneys, is actually standard therapy for certain types of acute heavy metal poisoning, such as iron overload due to transfusion, aluminum overload due to hemodialysis, copper toxicity due to Wilson’s disease, acute heavy metal toxicity, and a handful of other indications.

My personal interest in chelation therapy developed out of its use by unscrupulous practitioners who blamed autism on the mercury-containing thimerosal preservative that used to be in many childhood vaccines until 2001 but has since all but disappeared from such vaccines except for one vaccine (the flu vaccine, for which a thimerosal-free alternative is available) and in trace amounts in some other vaccines. Mercury became a convenient bogeyman to add to the list of “toxins” antivaccinationists hype in vaccines. In fact, my very first post after I introduced myself on this very blog discussed the idea that mercury in vaccines was a significant cause of autism and autism spectrum disorders, and I’ve periodically written about such things ever since, in particular the bad science of Mark and David Geier, whose idea that chemical castration of children with Lupron “works” against “mercury-induced” autism is based on a chemically ridiculous idea that somehow testosterone binds mercury and makes it harder to chelate. Unfortunately, this particular autism quackery has real consequences and has been responsible for the death of a child.

Chelation isn’t just for autism, however. Despite many practitioners advertising it for autism, cancer (often with dubious studies that I might have to take a look at), Alzheimer’s disease (which Hugh Fudenberg has blamed on the flu vaccine, a claim parroted by Bill Maher, of course!), and just about every ailment under the sun, it’s easy to forget that the original use for chelation therapy promoted by “alternative medicine” practitioners was for cardiovascular disease. When it is used for coronary artery disease or autism, on a strictly stoichiometric and pharmacological basis, it is extremely implausible. Moreover, it is not without potential complications, including renal damage and cardiac arrhythmias due to sudden drops in calcium levels. Such arrhythmias can and have led to death in children, and in adults complications such as renal failure and death.
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Posted in: Clinical Trials

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Fashionably toxic

It’s the toxins.

Toujours les toxines.

How many times have I read or heard from believers in “alternative” medicine that some disease or other is caused by “toxins”? I honestly can’t remember, but in alt-world, no matter what the disease or condition under discussion is, there’s a good chance that sooner or later it will be linked to “toxins.” It doesn’t matter if it’s cancer, autism, heart disease, diabetes, hypertension, or that general malaise that comes over people who, as British comedians Mitchell and Webb put it, have more money than sense; somehow, some way, someone will invoke “toxins.”

I was reminded of this obsession among believers in unscientific medicine last Friday when I came across an article by Guy Trebay in the New York Times entitled The Age of Purification. The article appeared, appropriately enough, in the Fashion section and was festooned with photos of cupping, surely one of the silliest of the many “detoxification” modalities that alternative medicine practitioners use to claim to draw the “toxins” out of their clients through the application of, well, cups or various other containers in which the air had been heated in order to generate negative pressure when sealed to the skin and presumably thus bring them to a greater level of purification and health. Indeed, the only “detoxification” rituals sillier than cupping that I can think of off the top of my head are detoxifying footpads and “detox foot baths.”

Oh, wait. Scratch that. I forgot about ear candling, which must surely be the undisputed silliest “detox” treatment of all time—until someone thinks of an even sillier one. Or not. There are just so many silly “detox” procedures that it’s hard to select a “winner.”

Be that as it may, Trebay mixes sarcasm with exposition throughout his article in a rather amusing way that’s worth quoting:

My friend, like everyone else around, seemed to believe that mysterious, amorphous sludge had lodged in the anatomical crannies of half the local adult population. Unseen toxins were lurking, like Communists during the Red Scare.

The “toxins” required elimination, somehow, and thus at lunches, at cocktails, at dinner parties, normal conversations turned abruptly from the day’s news to progress reports on juice fasts, energy alignments, radical purging. From painful sessions with traditional healers to toxin-leaching treatments designed, it might seem, to clean out not just body but wallet, a surprising number of New Yorkers (not all of them well-to-do neurotics) are caught up in a new New Age, the Age of Purification.

How had it happened, I wondered, that so many otherwise sensible, urban people found themselves in the grip of a dreadful feeling that systems are down? “I just bought five pounds of carrots, ginger and kale and put it all in my Breville juicer and pounded that all day,” said a corporate adviser of my acquaintance, far from a credulous woo-woo type.

Of course, as we have noted so many times before, hard-nosed skepticism in one area of one’s life does not necessarily translate to other areas. Many are the people who would never ever fall prey to scams in business, for example, but happily fork over money for scams such as “detox footpads”—or fall for anti-vaccine quackery, like J.B. Handley. Whatever the case, why this fascination with “detoxification” in alternative medicine? Why do so many of its treatments, be they dietary, chelation therapy, purges, colon cleanses, or whatever, claim to eliminate “toxins”? Why is it that, if you Google “alternative medicine” and “detoxification,” you find so many references, some of which claim external toxins need to be eliminated, some of which claim that internal toxins need to be purged, and still more of which blame various “parasites” for all manner of health distress? In this post, I’ll try to explain, but first a little history—self-history that is.
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Posted in: Naturopathy, Science and Medicine, Science and the Media, Vaccines

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The autism “biomed” movement: Uncontrolled and unethical experimentation on autistic children

Ever since I first discovered the anti-vaccine movement, first on Usenet, specifically on a Usenet newsgroup devoted to discussing alternative medicine (misc.health.alternative, or m.h.a. for short) and then later on web and on blogs, there have been two things that have horrified me. First, there are the claims that children suffer all sorts of harm from vaccines, be it being made autistic (with the attendant “autism epidemic” caused by vaccines), suffering neurological damage, immune system damage, and all manner of other adverse consequences. There is no good evidence for these claims (although, as has been documented right here on this very blog time and time again, anti-vaccine activists will trot out all manner of awful studies to support their contentions), but that doesn’t keep useful celebrity idiots like Jenny McCarthy, Jim Carrey, Don Imus, or Bill Maher from repeating the same myths over and over again. Worse, the permeation of society with these myths about vaccines has led to declining vaccination rates and the resurgence of potentially deadly vaccine-preventable diseases. It began first in the U.K. in the wake of Andrew Wakefield’s trial lawyer-funded, incompetent, and possibly fraudulent “research,” and has spread to the U.S., thanks to Jenny McCarthy and her ilk, who won’t take responsibility for their words and actions.

Even worse, the myth that vaccines cause autism has led to ideas. Dangerous ideas, and not because they “challenge” medical orthodoxy. These ideas are dangerous because they have direct consequences for children with autism. These consequences take the form of subjecting children to unscientific treatments that are ineffective at best and harmful at worst, sometimes even life-threatening. Indeed, I have written about case histories in which children were subjected to injections of “stem cells” into their cerebrospinal fluid by lumbar puncture and various other “treatments,” as well as chemical castration in combination with chelation therapy. That latter bit of quackery is something I wrote about years ago, but that the mainstream press only just noticed earlier this year. Better late than never, I guess. Even better than that, though, the same reporting team at the Chicago Tribune that reported on Mark and David Geier’s advocacy of Lupron to treat autistic children back in May. Sadly, the result of that story does not appear to have been actions by the State of Maryland to take away Dr. Mark Geier’s medical license or to go after his son David for practicing without a license. Neither does it appear to have resulted in insurance companies going after them for prescribing an expensive drug for an indication for which it is not appropriate. What it does appear to have done, however, is to inspire the same journalist, Trine Tsouderos, along with another journalist from the Chicago Tribune, Patricia Callahan, to pursue an even bigger target that Mark and David Geier, namely the entire “autism biomed movement,” which is for the most part rank quackery, in the following articles:

This is another rare case of excellent reporting on this issue, and I hope that this report (another installment of which was published early this morning after I had written this post) will grab the attention of more reporters and news outlets, leading to shining a light on the dark underbelly of the autism biomed movement.
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Posted in: Health Fraud, Herbs & Supplements, Public Health, Vaccines

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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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