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.