Alternative Medicine Critics Trash Chelation and TACT
You know the "gotcha" line – "Heads, I win … tails, you lose." Alternative medicine critics – arrogant medical school faculty, self-serving medical board members, and professional self-appointed quack-busters – like this "heads/tails" game. When the study demonstrates the alternative modality doesn't work, it proves their point; when the study shows the integrative modality works, then there's something wrong with the study. When the alternative treatment doesn't work and the patient doesn't improve, it proves their point; when the treatment works and the patient improves, it wasn't the treatment, it was the doctor's bedside manner, diet and exercise, placebo. From the medical school faculty and the quack-buster's point of view, alternative medicine is unscientific, not evidence based, ineffective, a waste of money, interfering with the patient's obtaining appropriate medical care, and dangerous. I am not talking about the medical school and medical board viewpoint of the 1950s or 1980s – I am talking about what medicine thinks about alternative, naturopathic, integrative, functional, orthomolecular medicine in 2014. Don't believe me? Search Wikipedia for the subject "alternative medicine." It is the consensus viewpoint of science and medicine in 2014 and it is not pretty. Despite all the accomplishments made in naturopathic and functional medicine over the past three decades, the scientific and medical communities disdain alternative medicine. It is time that the alternative medical community pick up their "swords" and attack the critics and naysayers.
The NIH-sponsored TACT (Trial to Assess Chelation Therapy), conducted over nine years, demonstrated a positive outcome in the prevention of heart attack, stroke, and death in patients having diabetes and myocardial infarction. This was a randomized, blinded study published in JAMA – just what the critics wanted – and the positive result was rejected not just in editorials but also on the page discussing "Chelation Therapy" in Wikipedia. The "open-minded" cardiologist might think that chelation offers risk protection that is wholly unique to medicine – no drug or surgical intervention is capable of offering a similar risk reduction for a cardiovascular event. This means that chelation would increase the odds that a diabetic patient with a history of heart attack would benefit with prescribed medication, surgical intervention if needed, and chelation. No one is arguing that chelation must be used instead of conventional therapy; instead it should be advised as an additional support. But the naysayers and critics won't have it. They actually claim that the study was rigged because it had research participants, doctors, who supported chelation and were members of societies that advocated chelation. TACT principal investigator Gervasio A. Lamas, MD, ended the report with a statement that the trial cannot recommend chelation for implementation without further study. Nevertheless, given the succession of a few small university-based chelation trials that had negative outcomes, the largest and longest randomized trial on chelation had a positive outcome and the naysayers want to condemn it as a fraudulent study! Chelation critics Kimball Atwood, MD, and David Gorski, MD, stated that "the final results of TACT, published in November 2012, showed no support for the use of chelation therapy in coronary heart disease, particularly the claims to reduce the need for coronary artery bypass grafting" (Wikipedia, "Chelation Therapy"). Of course, that was not the purpose of TACT, and the study did indeed support the use of chelation therapy in coronary heart disease. Readers should review the December 2013 Townsend Letter interview of Lamas by Kirk Hamilton.
In 2008 Atwood (anesthesiologist at Tufts University and editor of Scientific Review of Alternative Medicine), Elizabeth Woeckner (litigator for medical boards), Robert Baratz, MD, DDS, PhD (expert witness for medical board disciplinary litigation), and Wallace Sampson, MD (professor of medicine and editor-in-chief of Scientific Review of Alternative Medicine), authored a 89-page editorial epic titled "Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned" (Medscape J Med. 2008; 10:115). The Scientific Review of Alternative Medicine is a journal of review articles that purportedly demonstrates the failure or inefficacy and danger of alternative therapies. Hence, it is not surprising that Atwood, Woeckner, Baratz, and Sampson would author a highly scathing report about TACT, chelation, and the study's investigators. The authors employ, to borrow a Civil War term, a "scorched earth" approach to denigrate the science of chelation therapy and its proponents. For those doubting Thomases who think that my call to arms is unwarranted, please take an hour or so and wade through this document – not only do the authors tear apart every positive chelation study, but they also find every means to debase individual chelation doctors (yes, chelation doctors – you have the dubious honor of having your practices and public records discredited).
This is from the abstract of Atwood et al.:
We have investigated the method and the trial. … We present evidence that chelationists and their organization, the American College for Advancement in Medicine, used political connections to pressure the NIH to fund TACT. The TACT protocols justified the trial by misrepresenting case series and by ignoring evidence of the risks. The trial employs nearly 100 unfit co-investigators. It conflates disodium EDTA and another, somewhat safer drug. It lacks precautions necessary to minimize risks. The consent form reflects these shortcomings and fails to disclose apparent proprietary interests. The trial's outcome will be unreliable and almost certainly equivocal, thus defeating its stated purpose.
Wikipedia ("Chelation Therapy") cites Atwood et al.'s conclusion that "the proposed study has been criticized as unethical, unnecessary and dangerous, with multiple studies conducted in the past demonstrating that it provides no benefit."
Isn't it ironic that this unnecessary and dangerous study found that there was an overall 18% reduction in risk in having a cardiovascular event in the chelation group compared with the placebo group? TACT demonstrated that in the group of patients who had sustained prior to the study a large anterior wall myocardial infarction, a very vulnerable heart-disease population, there was a 40% reduction in risk in having a future major cardiovascular event. This is a potential benefit that current cardiac drugs are not capable of providing. Yet, Atwood and Gorski state that the study demonstrates no benefit for cardiac disease.
Yes, "Heads, I win … tails, you lose." The medical community "knows" that chelation doesn't work and is dangerous. The fact that TACT found minimal adverse events in the chelation treatment group can't be true. The fact that TACT found significant risk reduction in cardiovascular events in the treatment group can't be true. The only thing that matters is the few studies that demonstrated chelation failure and the editorial comments of the critics and naysayers.
FDA Clamps Down on Compounding Pharmacies
In 2012 a large number of patients developed fungal meningitis or a related fungal disorder as a result of being treated by a contaminated compounded steroid drug. The adulterated injectable was primarily manufactured by one pharmacy near Boston, the New England Compounding Center. Although the facility had been criticized and sanctioned by Massachusetts's pharmacy authorities during the previous five years, it had been able to continue making and distributing drugs to hospitals and clinics with impunity. Inspections had revealed that not only had the manufacturer failed to maintain sterile rooms, but drugs were made in the proximity of debris and contaminated materials. As a result of many patients' dying or requiring extensive treatment for resistant fungal infections, there was a public outcry for policing of compounding pharmacies. Congress could agree on little in 2013 but easily managed a bipartisan vote to direct the FDA to police compounding pharmacies. After Obama signed the legislation into law, the FDA did not waste time implementing the Compounding Quality Act. The FDA set up deadlines for a comment periods on the act – a March 4 deadline has now passed for comment on a section known as "Nomination for Lists" (of drugs that may or may not be compounded). Compounding pharmacies face a deadline of Oct. 1, 2014, to file an application to become an "outsourcing facility" (permitting the facility to compound a drug without needing to comply with drug manufacturing requirements). There is the distinct possibility that some and perhaps most compounded prescriptions will not be filled after Oct. 1. For those clinics and physicians who administer injectable chelation, vitamins, minerals, amino acids, herbals, and other nutraceuticals, this may mean that these injectables will be completely unavailable from compounding pharmacies and injectable manufacturers. For those clinics administering hormone therapies, there is the possibility that only brand-name and generic pharmaceutical hormones will be available; customized hormone prescriptions may be banned. What will be available and what will not be available will depend on whether the "drug" or "bulk substance" is approved on the FDA list of acceptable compounded drugs.
The rules of acceptance for compounding a bulk drug are:
1. The bulk drug substances comply with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary (NF) monograph, if one exists;
2. If such a monograph does not exist, the drug substance(s) is a component of an FDA-approved human drug product; or
3. If such a monograph does not exist and the drug substance is not a component of an FDA-approved human drug product, it appears on a list of bulk drug substances for use in compounding developed by FDA through regulation (section 503A(b)(1)(A)(i) of the FDCA).1
Furthermore, according to Section 503B, an "outsourcing facility may only compound with a bulk drug substance which appears on the FDA-established list of bulk drug substances for which there is a clinical need or which are on FDA's drug shortage list." Given the scare interest if not derision in the medical community regarding IV chelation and nutrient therapy, does it seem likely that the FDA will deem that injectable components have "a clinical need?"
Furthermore 21 CFR 216.24 asserts that there will be "a list of drugs that may not be compounded because they have been withdrawn or removed from the market because the drugs or components of the drugs have been found to be unsafe or not effective. Compounders may not compound any drugs that appear on this list." Hence, many compounded prescriptions will be banned because the FDA will be listing the drugs as "unsafe" or "ineffective." Physicians who prescribe compounded prescriptions will find their hands tied with these regulations. Clinics administering IV therapies will be very limited because the majority of IV components are only available through compounding. Patient prescriptions will not be filled or renewed due to the FDA policies.
It is unclear how we should approach the FDA to ensure that injectables, hormones, and other compounded substances will be approved for compounding. Efforts at approaching legislators and the general media have not been effective – the public consensus has been that because of the NECC fiasco, compounding pharmacies must be reined in and policed. While a compounding pharmacy may apply to be an "outsourcing facility," the onerous requirements of the state pharmacy board and FDA inspections may prove to be too difficult and expensive. Additionally the FDA authorized a "Memorandum of Understanding between the FDA and the States (MOU)" that requires that there may not be an "inordinate amount" of interstate compounded prescribing. The FDA is proposing that compounders may not send more than 5% of their compounded prescriptions across state lines. In addition to the administrative nightmare of limiting interstate compounding to 5% of their prescriptions, pharmacies would not be able to afford making injectables without being able to do business with out-of-state clinics. Furthermore, a compounding pharmacy making injectables requires a certified sterile facility – a financial and manufacturing commitment exceeding the capabilities of most compounding pharmacists.
All clinicians and practitioners who use injectables or prescribe compounded hormones should confer and strategize with their compounding pharmacist about the FDA implementation of the Compounding Quality Act. Waiting until the FDA takes action will be too late!
Jonathan Collin, MD
1. FDA implementation of the Compounding Quality Act [Web page]. http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm375804.htm
2. Compounding and the FDA: questions and answers [Web page]. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm
3. Text of Compounding Quality Act [online document]. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm376732.htm