Clinical trials Complementary and alternative medicine Pseudoscience Quackery Science Skepticism/critical thinking

Your tax dollars at work: New clinical trial of chelation therapy, new and old quacks enrolling patients

Whenever I refer to quackademic medicine and how the infiltration of quackery into medical academia has led to unethical clinical that are not only pseudoscientific wastes of money but potentially downright harmful to patients, two always come to mind. The first is the trial that tested the late Nicholas Gonzalez’s protocol for advanced pancreatic cancer, comparing it to standard-of-care chemotherapy. His protocol basically involves a combination of supplements (up to 150 a day), various vegetable juices, and, yes, the infamous coffee enema—several a day, actually. It’s basically a mystical, magical hodgepodge of woo that resembles the Gerson protocol. Yet, flush with enthusiasm for investigating implausible treatments of alternative medicine, the National Center for Complementary and Integrative Health (NCCIH), which was then called the National Center for Complementary and Alternative Medicine (NCCAM) approved the study based on a small case series of patients treated with the Gonzalez protocol whose seemingly fantastic results could easily be explained by selection bias. The trial was an absolute disaster, with patients treated with the Gonzalez protocol doing much worse than patients treated with standard-of-care chemotherapy, and that’s saying something given how poorly patients with pancreatic cancer do in general. Gonzalez made a lot of excuses, but those excuses couldn’t change the fact that a couple of million dollars had been wasted on a protocol that had no chance of working and patients in the Gonzalez protocol arm suffered unnecessarily.

The second example I use is, of course, TACT (the Trial To Asess Chelation Therapy), which makes the Gonzalez trial look tiny in comparison. After all, the NIH funded it for $30 million. When its results were finally revealed, they were, in essence, negative. There was no difference between any of the chelation groups in the composite endpoint that consisted of death, MI, stroke, coronary revascularization and hospitalization for angina, although here was one subgroup that showed a seemingly positive result: Diabetics. There was also a barely statistically significant benefit among those with a previous MI. However, there were no statistically significant differences in any of the individual events aggregated to form the composite endpoint, other than deaths among diabetics. Moreover, the result among diabetics was a result that could well have been spurious. So, in reality, the appropriate way to report the results was that chelation therapy doesn’t work, with the possible (slightly possible) exception of in diabetics, particularly diabetics with previous cardiac events. Overall, TACT is not particularly good evidence for an effect of chelation therapy on cardiovascular disease. Not surprisingly, Dr. Gervasio Lamas, the principal investigator of TACT, was very unhappy with all the criticism, and his responses were not particularly convincing.

So, of course, last week a press release was issued announcing that Bride of TACT Son of TACT—OK, TACT2—had been funded through a grant from the NIH, including NCCIH and the National Heart, Lung, and Blood Institute (NHLBI). Naturally, I was not pleased. I was also disappointed that Dr. Josephine Briggs had betrayed the promise in NCCIH’s last two strategic plans to do some real science for a change by allowing NCCIH to contribute to this grant. More importantly, what the hell was the leadership of NHLBI thinking? I expect nonsense like this from NCCIH, but not from NHLBI. Whatever the rationale, what TACT2 proves is that in quackademia, pseudoscientific clinical trials never die. Like Jason Voorhees, Freddy Krueger, and Michael Myers, just when you think they’re dead, they return from the dead. So it is with TACT2.

Be that as it may, although I mentioned it in passing, there was one aspect that I didn’t cover sufficiently in my last post. That was mainly because I didn’t have the tools then. I’m referring to the quack clinics that enrolled patients on TACT the first time around and how at least some of them had compromised blinding. In any case, back then, Dr. R. W. Donnell noted that only 12 of the 110 study sites were located at academic medical centers and that a substantial number were basically quack clinics peddling pseudoscientific health claims and practices. He even did what he called a “magical mystery tour” of some of these clinics, which included, for example, the Marino Center for Progressive Health in Cambridge, Massachusetts, which featured acupuncture, chelation and chiropractic, and an IV therapy program that offers intravenous therapy for multiple ailments. Another center, Innovative Medicine in Lafayette, IN, offered chelation therapy, hyperbaric oxygen, “advanced thyroid replacement”, chiropractic, acupuncture and “multiple powerful intravenous therapies.” They also claim that chronic neurologic diseases of any type usually respond to hyperbaric oxygen.

Given this background, I wondered: Is the same thing happening with TACT2? Then a reader pointed out that there is a website for TACT2 looking for clinical sites for the trial. It also has a map with current TACT2 sites. This time around, I’ll note that more university sites are available, including Stanford University, Baylor St. Luke’s in Houston, Johns Hopkins Bayview Medical Center, the University of Ottawa Heart Institute, and Universith Hospitals of Cleveland, the latter of which saddened me greatly, as that’s where I did my surgery residency.

However, the overwhelming number of TACT2 sites are not academic medical centers, and, now as it was 10 years ago, there are already a lot of quack sites enrolling patients for TACT2, so many that I’m already tempted to do my own version of Dr. Donnell’s magical mystery tour from a decade ago. So the first thing I did was to look to see if any of the same sites featured by Dr. Donnell as TACT sites have signed up for the sequel. The first one I found, unfortunately, was the Born Clinic, which was a TACT site and is now a TACT2 site. It offers chelation therapy (of course), as well as acupuncture, prolotherapy, thermography, and other dubious treatments. It’s actually one of the “less bad” clinics.

The Magaziner Center for Wellness in Cherry Hill, NJ is another TACT site that’s re-upped for TACT2, as well. Dr. Donnell noted that the Magaziner Center offered “a variety of alternative treatments including hyperbaric oxygen therapy for neurologic diseases.” Guess what? Ten years later, it still does:

HBOT is prescribed for conditions such as cancer, Lyme disease, ADD/ADHD, stroke, migraines, autism, chronic fatigue, multiple sclerosis, cerebral palsy, Parkinson’s disease, Alzheimer’s disease, Crohn’s disease, Bell’s palsy, carbon monoxide poisoning, excessive blood loss, gangrene, radiation necrosis, diabetic foot ulcers, severe anemia and much more.

Of note, Dr. Allan Magaziner has written books like The All-Natural Cardio Cure: A Drug-Free Cholesterol and Cardiac Inflammation Reduction Program and Chemical Free Kids: Safeguarding Your Child’s Diet and Environment. (Here’s a hint: It’s impossible to make kids “chemical-free.”) He also brags about being cited in books by Suzanne Somers’, which, to be honest, is not something I would ever brag about. He’s also a past president of American College for Advancement in Medicine (ACAM), an organization that Kimball Atwood quite accurately referred to as the “mother of all pseudomedical pseudoprofessional organizations” and part of the house that Laetrile built. In other words, it’s the quack organization to end all quack organizations.

Another familiar name comes up, although I don’t recall if his was a site used in the original TACT. He’s on board for TACT2, though. His name is Michael Schachter, and he’s been practicing cancer quackery since at least the 1970s. It’s how he still treats cancer:

Treatment options at the Schachter Center include detoxification, dietary protocols, and nutritional supplements that enhance and support the immune system and the healing process. Oral supplements include: vitamins, minerals, enzymes, herbs, phytonutrients, and other nutritional supplements. Intravenous hydrogen peroxide and/or intravenous infusions of high doses of vitamin C are often recommended. We frequently recommend other natural substances that appear to have some anti-cancer properties, for certain patients.

Extensive testing may be done to evaluate nutritional status (direct or functional vitamin tests, serum coenzyme Q10, red blood cell minerals), heavy metal toxicity (provoked urine tests for mercury, lead, and others), the status of the liver’s detoxification mechanisms, hormone status (DHEA levels, basal temperatures for thyroid function, and others) and immune status (Natural Killer Cell functional activity). Of course, standard tests such as a complete blood count, liver chemistry tests, and blood cancer markers are routinely ordered, especially if they haven’t been done recently.

We also utilize the innovative, non-toxic, biological compounds developed by the late Dr. Mirko Beljanski, and have recently added therapies utilizing vitamin D, vitamin K2, Salvestrols, balancing lipids, the use of iodine and important dietary changes. The value of exercise is also stressed.

Yep, it’s all there: “detox” quackery, “boosting the immune system,” intravenous peroxide, high dose vitamin C, provoked urine tests, and more! (He even offers reiki.) And this is the sort of guy that Dr. Lamas is going to trust to sign up patients for TACT2? Apparently so, even though his website includes a Quack Miranda Warning.

That’s not all, though. Here’s another center that’s signing up patients for TACT2, Delaware Integrative Medicine, fronted by Dr. Henry Childers IV, FAAO, who describes himself as “board certified in General Surgery, and Cardiothoracic Surgery, with advanced certificates in both FSM and ozone therapy,” a “fellow in the American Academy of Ozone Therapy” and “co-investigator on the Health and Human Services Institutional Review Board Ozone efficacy research study.” I groaned when I read that. Damn. A fellow surgeon, but turned to quackery. Indeed, he peddles something he calls “cellular medicine” (whatever that is), complete with impressive woo babble (like technobabble in Star Trek but with woo):

Cellular medicine works by harnessing the body’s innate ability to grow and heal itself without all the drugs and invasive procedures that have become so prevalent in medicine today. It is effective because it works on the cellular level by stimulating gene expression, enhancing cellular metabolism, improving oxygen utilization, increases cellular detoxification including up-regulating hundreds of antioxidant’s response elements. Treatments such as Ozone Therapy can induce a rearrangement of the biochemical pathways, thereby activating second messengers in a cascade with a multiple system action.

Cellular medicine dramatically increases ATP and protein synthesis–all which improve cellular function. Treatment results in a dramatic decrease in pain and inflammation while increasing blood supply and growth factors. These cellular changes, and the resulting repair and regeneration of injured tissue leads to organ and consequently total-body wellness. Our cells and tissues function like they did when we were in our 20s.

According to his website, Dr. Childers offers everything from chelation therapy to ozone therapy to ultraviolet blood irradiation to all manner of “detoxification” quackery. He even offers something he calls “Chela-zone Therapy,” which is:

Chela-zone therapy consists of a combination of chelation therapy and ozone therapy and greatly enhances the already well-documented efficacy of chelation therapy. Chelation therapy improves circulation, enabling more oxygen to reach the cells. Ozonotherapy enables the cells to use the oxygen that is being delivered with a much higher level of efficacy. The two modalities are truly synergistic, and the results of either a greatly increased when they are administered together. For this reason, in most clinical situation, we prefer chela-zone treatment over chelation therapy alone.

Because, why not combine the two? In woo world, quacks always find a way to combine two different pseudoscientific treatments? One wonders how Dr. Childers can sign up patients for TACT2 if he believes combining chelation therapy with ozone therapy is superior to both.

Best not to ask questions.

Here’s what I see happening. TACT2 is an utterly unnecessary study that, in pursuit of “proving” that an alternative treatment “works,” will waste $37 million of my taxpayer dollars following up on a result that was almost certainly spurious. In the process, it will expose high risk diabetic patients with cardiovascular disease to a potentially dangerous treatment, with no good reason to expect that it will benefit them. Yes, it will be somewhat better than TACT in that there do appear to be more academic institutions on board this time around, but there are also a lot of quack clinics, some of which are the same quack clinics that participated in the original TACT study.

In conclusion, TACT2 is, just like its predecessor, a profoundly unethical study rooted in pure pseudoscience and quackery. Although the proportion of study sites at academic medical centers will be much higher than in TACT,, most likely thanks to the proliferation of quackademic medicine in the decade since the original TACT study was getting under way and the effective spin of a negative or spurious result into a “positive” one, they will nonetheless still be a relatively small minority in TACT2 and there are already a fair number of quack clinics that have registered as TACT2 study sites. Indeed, I can’t help but wonder which institutional review boards (IRBs) approved these studies, given that these “integrative” medicine clinics almost certainly don’t have IRBs of their own. It’s sometimes said that insanity is doing the same thing over and over and over and expecting different results. By that definition, TACT2 is insanity. I also expect that its results will be basically the same as TACT: A subgroup showing an apparent benefit and possibly a barely statistically significant result. (I hope I’m wrong, but I’d put money on this.) This will then lead to another $37 million or more for the mandated followup trial to chase after a supposedly positive result.

Quackademic medicine marches on. Maybe I’ll have to keep an eye on the TACT2 website and check out some of the clinics signing up patients. I’ve barely scratched the surface, and I expect more quacks will be joining the study. In fact, I’d be surprised if they didn’t.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

46 replies on “Your tax dollars at work: New clinical trial of chelation therapy, new and old quacks enrolling patients”

It doesn’t surprise me that Dr Magaziner is a TACT proponent. He’s very fond of any and all kinds of woo for which he can perform a thorough walletectomy on his marks…er….patients.

@ herr doktor bimler

the late Dr. Mirko Beljanski

** reading the wiki article **
Uh, he was treating French President Mitterrand for his cancer? I never knew.

** switch to the French version of the wiki article, much longer **
Lots of background. A scientist who started well and then went spiraling down the rabbit hole.

Bit frightening, all of these untested plant extracts his relatives are selling.
Among the basis for the rejection of his drugs by the authorities, some are extracted from a Brazilian plant, except that the name could designate half a dozen plants, and at least two of them are full of highly toxic alkaloids.
Clinical trial in Montpellier: 2 patients.

Oh, Luc Montagnier likes him. And Beljanski’s plant product is working, not because of its impeding action on DNA replication (Beljanski’s rationale – his life’s work was about discovering DNA or RNA transcriptases and retro-transcriptases), but because it’s an antioxidant, and also boosting the immune system.
Stop helping, Luc.

** check the wiki references **
Oh joy, more French woo.

What a surprise! He died of cancer.

Let’s be fair, at that point he didn’t have access to his drugs anymore (at least whose produced in France).
OTOH, when he was treating my former president, who nonetheless died of his cancer…

University of Ottawa Heart Institute

Granted the rules may be different for NIH, but NSF and NASA do not allow direct funding of researchers at non-US institutions. Is NIH’s Canadian counterpart contributing to this farce? Perhaps one of our Canadian readers could comment.

I also have to ask whether these non-academic clinics have IRBs, or whether the PI’s institution covers that for them.

A credulous local TV reporter named Emily Lampa has done several stories attempting to legitimize fake “chronic lyme” diagnoses. Henry Childers is (or was) a “lyme literate” quack and member of the rogue organization ILADS.

She interviewed some of Henry Childers’s patients as they were receiving intravenous ozone treatment. The bill was supposedly $9,000 (out of pocket) for a course of treatment. The few minutes of interviews are textbook examples of how quackery works.

One patient believes waxing and waning of pain means the ozone is working: “There’s been a lot of ups and downs and that’s been frustrating but I know it’s working because I wouldn’t have those ups and downs of it wasn’t doing something.”

Childers writes off the idea that it might be a placebo effect: “I don’t like anecdotal data but when you treat people who have had decades or years worth of symptoms, debilitating that affect every aspect of your life and all of a sudden it’s getting better who cares? They’re getting better. It’s not any voodoo stuff. It’s just open up the biochemistry book. It’s all in there.”

Lampa posted the full interviews with the patients, where you learn more about their stories. It turns out that a lot of the stories are questionable. For example, one patient was initially diagnosed by a psychic “medical intuitive”.

The reporter notes how protective the patients are of Childers, how they will do anything to protect him from being prosecuted.

I might have to take a closer look at Dr. Childers sometime in the near future, maybe one day when there’s nothing in the news interesting enough for me to blog about. His “Chela-zone” therapy is a form of quackery I’ve never encountered before.

Cellular medicine dramatically increases ATP and protein synthesis

I’m pretty sure this is what the Incredible Hulk relies upon. I always thought all that gamma-ray malarkey was a bunch of a lies.

I cannot help it, but every time I see the words chelation therapy , especially in connection to CAM, woo, etc., I catch myself thinking “cheating” therapy.

I’m not an expert on statistics, so I’m asking when a study fails to meet its endpoints, but a post hoc analysis finds a statistically significant result in a subgroup, is it really possible to assign a p-value?

I’m not an expert on statistics, so I’m asking when a study fails to meet its endpoints, but a post hoc analysis finds a statistically significant result in a subgroup, is it really possible to assign a p-value?

IANAEOS either, but sure. As always, the question is whether they mean anything.

[email protected]: There is a reason Mark Twain classified untruths into three categories: lies, damn lies, and statistics. Or to put it another way: Figures can’t lie, but liars can figure.

One of the things about post-hoc analyses is that it becomes tempting to torture the data until it confesses. I can’t say for sure whether that happened in this case, but it is good reason to be skeptical.

Your tax dollars are also going to double deaths due to fouling access to a natural herb, kratom, in favor of pharmaceutical companies raping the alkoloids for patents and profits. There is an opiod epidemic in this country — Heckuvajob Chucky (Rosenberg).

The ban on kratom — a safe and popular treatment for chronic pain, depression, anxiety and PTSD — is inexplicable

I looked into kratom when I heard on the impending ban. The liver toxicity issue is scary enough that the ban seems reasonable.

I read the Salon article. The author clearly doesn’t know what he’s talking about. Kratom is not safe. Raw opium is safer.

The liver toxicity issue is scary enough

And yet, tylenol/acetaminopen/paracetemal which is the #1 cause of liver failure in the U.S. is not banned.

Gilbert, you’re so far off topic you’re not even in the same section of the alphabet.

What does this have to do with chelating diabetics to treat heart disease?

He’s hijacking the conversation to complain he can’t get access to his dope legally anymore.

Gilbert, the difference between kratom and acetaminophen is the latter is produced under controls that maintain consistency in dosing and quality, and that dosing is well understood. If you stay within dosing guidelines, you are unlikely to injure your liver.

With kratom, you don’t know from one dose to the next how much of the active ingredient you’re getting, how pure it is, and no one knows how much is actually safe to consume. Without controls, you don’t know whether or not your dope is contaminated with something nasty . . . like heavy metals.

You wouldn’t want to end up need chelation therapy now, would you?

You should know by now that everything with Gilbert is about him wanting to get high.

Not that there is anything wrong with that, but it gets boring.

and that dosing is well understood. If you stay within dosing guidelines, you are unlikely to injure your liver.

Ohh. But what happens to the ‘guidelines’ if one happens to concurrently ingest alcohol? ****fuck**** those people who should’v known better from the warning that still doesn’t exist.

and that dosing is well understood. If you stay within dosing guidelines, you are unlikely to injure your liver.

Ohh. But what happens to the ‘guidelines’ if one happens to concurrently ingest alcohol? Intercourse*** those people who should’v known better from the warning that still doesn’t exist.

*** And by ‘intercourse’ i mean F… You.

Gilbert, this post is not about kratom. Your hijacking the thread is not appreciated. Knock it off. I’m putting you into automatic moderation. Any posts that are about kratom will not be approved.

“FSM and ozone therapy?” So their treatments involve petitioning for the healing touch of His Noodly Appendage too?

@ Anonymous Coward

All treatments should involve His Noodlynes, for he Touches All!*

* Whether they like it or not!

” Quelle surprise”

Pro tip:
If you’re going to insult Orac**, you should AT THE VERY LEAST be original enough not to steal an idiom he uses frequently in doing so. Seriously.

** not that I think that anyone should insult Orac but it’s the principle of the thing!

I have a coworker who used HBOT (among other things, mostly SBM) after a massive head injury. I guess it wasn’t covered by insurance because she complained that the cheapest place to get it done was a quack’s office where one day a patient came back into the waiting room while still “steaming her hoo-haa”. (Complete with tubing.)

So while there’s a time and a place for HBOT, it also seems to be a warning flag of serious wackiness.

you should AT THE VERY LEAST be original enough not to steal an idiom he uses frequently

Sorry, Denice Walter. It was the only sufficiently mocking thing that I could come up with in short order before the ‘moderate’ kicked in.

Raw opium is safer.

What an ignorant, assinine statement**. It’s good Orac ran interferrance for you, Mark Thorson, before you need feel the sting and stink of being a dirty floor mop.

People are using it in lew of other substances, illicite and pharmaceutical. It is breaking people’s addiction to opiates, methamphetamine, and alcohol. It takes away people’s pain. It has a mild elevating effect like coffee; Which is not surprizing because this dangerous plant is in the coffee family.

I certainly see how it is a threat to drug company profits — Most of the current ‘epidemic’ is due to pharma’s promulgating their tylenol-poisoned pain pills and oxycontin; Now they want to pretend to clean up the mess with more patented offerings. Your duckspeak and misinformation is going to destroy untold many lives; Not just prison time, but in amplified addiction and its’ concomitant fatality.

Chronic use of kratom recreationally has been associated with rare instances of acute liver injury.

Most people don’t use it ‘recreationally’ as there is not much of a high there other than like caffein (which accounts for thousands of poison control calls per year). Also, no one has died from said liver injury — the 15 world-wide recorded deaths** all involved other substances or adulteration; Usually with things approved by the FDA such as Tramadol homologs. The DEA admits this. Also, ****** does not cause one to take a break from breathing as opiates do.

Do you have a citation for said prevelance of liver injury or death thereof? I did not think so. So why do you insist it is terrible for the liver? Is it just *assumed* on your part? You obviously discount ‘harm reduction’ when it comes to pain, addiction, or depression and how it relates to deaths.

** In 2014, there were 458 Tylenol deaths in the US and thousands of liver injury and its’ attendant health problems.

Acetaminophen overdose sends as many as 78,000 Americans to the emergency room annually and results in 33,000 hospitalizations a year, federal data shows. Acetaminophen is also the nation’s leading cause of acute liver failure

Ok. I grant you that opium is kind on the liver. However, it is not currently legal. And there is that whole taking a break from breathing thing with an OD.

Orac did not approve the comment I posted of the statistics on the hundreds of thousands of ER visits or the 458 liver failure deaths a year from tylenol** — It doesn’t matter if it is used ‘within the dosing guidelines’ as there is still a great human toll due to it.

There are thousands of admissions due to caffeine — not banned
There are thousands of admissions due to alcohol — not banned

Would a ban on coffee and daqueries not fit in with your plans, Mark Thorson?

I’d still like to see a citation backing your claim that brand X ‘wrecks your liver’.

**His portfolio may be a little bit to heavy on McNeil Consumer Healthcare and/or Johnson & Johnson.

In that case, I understand completely and my condolences are offered.

“You should know by now that everything with Gilbert is about him wanting to get high.”

LoL Johnny. Well if you call drinking a couple cups of coffee *getting high*. The DEA is wrongheaded on this for some reason. There is no ” imminent hazard to public safety”, the stuff has been sold in the states for decades.

“You should know by now that everything with Gilbert is about him wanting to get high.”

LoL Johnny. Well if you call drinking a couple cups of coffee *getting high*.

You know, Timmeh, you were doing so well sticking to the “Gilbert” pseudonym. I mean, I didn’t agree with the original sentiment, but that largely involves having an even lower opinion of you.

So, now, “sullenbode” joins “Mitzi Dupree” and the rest. (Were you also “Clayton Bigsby”? I’ve only recently started having to categorize the script entries.)

Lol Narad. “Mitzi Dupree” is a Deep Purple song–

she said hi i am mitzi
the queen of the ping pong
where you going boy
i said nowhere
she said i’m movng on
i thought what is this
i cannot resist
here she is
and i’ve always wanted a girl
with a name
a name like mitzi dupree

You don’t get out much, do you Narad?

The liver toxicity issue is scary enough that the ban seems reasonable.

I’m still waiting for that citation, Mark Thorson #17. Ohh, no citation? Perhaps it is because you were thinking of kava kava?

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