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Pitfalls in Regulating Physicians. Part 1

I had intended today’s posting to be a summary of a real case faced by a state medical board. It is a case of licensed physicians treating patients with a substandard, dangerous, and unequivocally illegal method. My intent was to use it as an illustration of how difficult it can be for medical boards to discipline such practitioners, even when the treatment involved is obviously, blatantly bad. Only yesterday, I was informed by the pertinent board that because this case has yet to be resolved, I may not discuss it. So be it: I’ll save the specifics for another time. Instead I’ll offer a general example of a dubious treatment as a prelude to Part 2 of this series,† which will attempt to discover some of the reasons that medical boards might, under such circumstances, be ineffectual.

Intravenous Hydrogen Peroxide

Hydrogen peroxide (H2O2) is a highly reactive compound that is caustic to living tissues. It spontaneously decomposes to water and oxygen, a reaction that is greatly accelerated in the presence of peroxidases (mainly catalase), which are ubiquitous in human blood and tissues. It has been used as a disinfectant for superficial skin wounds and in the mouth, and also for fabric and medical equipment. It has been used as a bleaching agent for teeth and hair. When used as an irrigant in surgical fields, in other large wounds, or consumed in any form (including intravenously), however, it has resulted in predictable, catastrophic complications: arterial and venous gas emboli, emphysema, respiratory arrest, strokes, multiple cerebral infarcts, seizures, colonic ulcers, intestinal gangrene, acute hemolytic crises, shock, cardiac arrest, and death.[1-7]

Hydrogen peroxide is also made in minute quantities by most eukaryotic cells, including those in humans. It is one of the “reactive oxygen species” involved in redox reactions, most importantly lipid metabolism. It is also involved in the destruction of microorganisms by phagocytic cells. In order to protect against toxicity, our cells sequester H2O2 in special organelles (peroxisomes) and tightly regulate both its synthesis and its decomposition.[8] When such regulation fails, endogenous hydrogen peroxide contributes to disease states, including hepatic necrosis and adult respiratory distress syndrome—probably because when it leaks from damaged cells it destroys the lipid cell membranes of other cells, leading to a vicious cycle of inflammation and cell destruction.[9]

IV H2O2 is “Fraudulent, Dangerous, and Illegal”

According to Thompson Micromedex, an authoritative drug information database, intravenous hydrogen peroxide is fraudulent, dangerous, and illegal:

GENERAL INFORMATION: Thirty-five percent hydrogen peroxide (“35% Food Grade Hydrogen Peroxide”) to be diluted and used in “Hyper-oxygenation Therapy” for AIDS, CANCERS and more than 60 other conditions (acne, gum disease, athlete’s foot, colic, headache, varicose veins) is fraudulent, dangerous, and illegal, and distributors have been actively restrained by US Food and Drug Administration (FDA) action since 1985. The liquid has been purchased in bulk from chemical plants in Texas and Mexico and repackaged into smaller containers by distributors. Stored in home refrigerators according to the manufacturers instructions, the corrosive chemical has been mistaken for water and consumed. The products – sometimes called “Biowater” and “H2O2” – are promoted as an “alternative medicine” by mail-order distributors. Materials promoting the product often include printed pages resembling magazine articles along with alleged testimonials that blend various medical facts with fictitious claims and offer the view that hydrogen peroxide’s benefits are suppressed by the medical establishment and the government. FDA is not aware of any medical benefits from consuming hydrogen peroxide in any form; no information or applications have been submitted to the agency to support any drug claims for taking this chemical internally (Anon, 1989).

Anon: FDA Mailgram. April 14, 1989.

Enter the Fringe, eh?

In spite of such dangers, for the past 25 years a fringe group of practitioners has advocated the use of intravenous hydrogen peroxide for a multitude of indications.[2] The champion of this method was the late Charles H. Farr, MD, PhD (1927-1998), the self-styled “father of oxidative medicine.” (“Oxidative medicine” or “oxidative therapy” includes the use of hydrogen peroxide, ozone, and other substances). Farr claimed to have discovered “a positive metabolic effect to intravenous infusions of hydrogen peroxide”[10], but never published an article on the subject in a peer-reviewed journal.  Instead, he founded the International Bio-Oxidative Medicine Foundation (IBOMF) and the International Oxidative Medicine Association (IOMA) to promote this and other dubious methods through courses, brochures, and highly questionable “studies.”[11]

Of the 87 IBOMF/IOMA members listed in 1999, at least 27 have been subject to medical board or legal actions. The FDA effectively shut down the IBOMF Institutional Review Board (IRB) in 1997, after an inspector found that it was a sham. Recently, the IBOMF/IOMA appears to have been absorbed by the American College for Advancement in Medicine (ACAM), the major advocacy group for another dangerous and substandard treatment, “chelation therapy.”

Farr claimed safety and near-panacea effects for IV H2O2. His organization, the IBOMF, issued a brochure for patients that states, in part:

Oxidation administered through hydrogen peroxide therapy regulates tissue repair, cellular respiration, growth, immune functions, the energy system, most hormone systems, and the production of cytokines (chemical messengers that are involved in the regulation of almost every system in the body). Oxidation can also work as a defense system, directly destroying invading bacteria, viruses, yeast, and parasites.

Hydrogen peroxide is used for a variety of health problems, including AIDS, arthritis, cancer, candidiasis, chronic fatigue syndrome, depression, lupus erythematosus,…emphysema, multiple sclerosis, varicose veins, and fractures.

There are few, if any, side effects with hydrogen peroxide therapy.

The evidence for these claims is not credible.[11] The language, moreover, appears to constitute illegal “misbranding” of IV H2O2 for the purposes of the Federal Food, Drug and Cosmetic Act. The IBOMF also issued a model consent form, including in part:

I understand that despite the history of use of intravenous hydrogen peroxide, it may considered experimental [sic]. Because it is not standard therapy yet in the United States, you cannot and do not offer this procedure to me except upon the condition that I release you from any legal responsibility resulting from the administration of intravenous hydrogen peroxide in my case and/or any medical treatment that may be necessary as a result thereof.

Such exculpatory language is considered unethical by major human studies treatises and is expressly prohibited, for human trials, by the Code of Federal Regulations.

Dilution is not the Solution

Advocates claim that the risks of intravenous hydrogen peroxide are non-existent at the concentration that they recommend, which is less than 0.1%. Nevertheless, no safe dose of H2O2 has been established.[1,12] A recent death in South Carolina was judged by the coroner to have been caused by a single infusion of H2O2. The drug had reportedly been given according to the “well-established protocols” of the International Oxidative Medicine Association.[7]

Earn CMEs while Learning Quackery!

How, then, can this dangerous and illegal method be so openly advocated? Googling “hydrogen peroxide” yields countless hits, almost all of them promotional. The ACAM, which refers to itself as “the voice of integrative medicine,” offers regular courses in IV H2O2, chelation, and other dubious treatments, for which physicians receive Continuing Medical Education credits. Here is its pitch for a course a couple of weeks from now in Las Vegas:

Statement of Need:
We are in a time of increasing toxicity, weakened immune systems, rising infections, and circulatory impairment. Therapies of little toxicity are desperately needed to address these conditions. Oxidation therapy provides solutions to these challenges by stimulating the body to correct imbalances and restore its physiology with virtually no toxicity.

Target audience:
All physicians searching for therapies of great efficacy and little if any toxicity for the disorders of modern times.

Course Learning objectives:

At the conclusion of this educational activity, participants will be able to:

1. Describe basic oxidation therapy with the four available modalities: hydrogen peroxide, ozone, UBI and IV-C.
2. Employ hydrogen peroxide therapy, IV-C, and basic UBI therapy, with a strong understanding of ozone therapy.
3. Summarize the basic science of intravenous vitamin C as an additional oxidation therapy.
4. Utilize the theory, mechanisms of action, biochemistry, clinical research and applications of oxidation therapy for routine clinical setting in integrative practice.

Hmmm. According to the Accreditation Council for Continuing Medical Education (ACCME),

Continuing medical education consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. The content of CME is that body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public.

How can the ACAM, an organization that portrays itself as “selecting the most valid and reliable evidence for the topic being addressed” make such brazenly ridiculous statements as those in its pitch for “oxidation therapy”? In two weeks, I’ll offer a few possible explanations.

References:

  1. Anon. Hydrogen Peroxide. In: Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Accessed 10/05 at: http://www.thomsonhc.com
  2. Green S. Oxygenation Therapy: Unproven Treatments for Cancer and AIDS. Scientific Review of Alternative Medicine 1998;2,1:6-12. Available at: http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/oxygen.html 
  3. Jordan KS, Mackey D, Garvey E. A 39-year-old man with acute hemolytic crisis secondary to intravenous injection of hydrogen peroxide. J Emerg Nurs. 1991 Feb;17(1):8-10.
  4. Before the North Carolina State Medical Board. In re: John Carl Pittman, MD. Notice of Charges and Allegations, 05/15/2002. Available at: http://glsuite.ncmedboard.org/DataTier/Documents/Repository/LegacyImages/00/00/81/00008149.tif
  5. Hirschtick RE, et al. Death from an unconventional therapy for AIDS. Ann Intern Med 1994; 120: 694
  6. Gordon SM, et al. Hemolysis associated with hydrogen peroxide at a pediatric dialysis center. Am J Nephrol 1990; 10: 123-7
  7. Breed AG, Associated Press. Peroxide therapy leads to a patient’s death in South Carolina. The Barre Montpelier Times Argus. Jan. 2, 2005. Available at: http://www.timesargus.com/apps/pbcs.dll/article?AID=/20050102/NEWS/501020313/1014
  8. Devlin TM (ed.). Textbook of Biochemistry with Clinical Correlations. 5th Edition. New York, Wiley-Liss. 2002. P.22
  9. Traub SJ, Nelson LS. Chemical Principles: Reactive Oxygen Species. In: Goldfrank LR (ed.). Toxicologic Emergencies. 7th Edition. New York, McGraw-Hill. 2002. pp. 190-192
  10. Farr CH. Workbook on Free Radical Chemistry and Hydrogen Peroxide Metabolism. Including Protocol for the Intravenous Administration of Hydrogen Peroxide. “Common Law Copyright, 1989-1996, IBOM Foundation, P.O. Box 891954 Oklahoma City, OK 73189.”
  11. Atwood KC. Charles H. Farr and the Purported Scientific and Medical Rationale for Intravenous Hydrogen Peroxide. Scientific Review of Alternative Medicine. In press.
  12. U.S. Congress, Office of Technology Assessment. Oxygen Treatments. In:  Unconventional Cancer Treatments. OTA-H-405 (Washington, DC: U.S. Government Printing Office, September 1990). P. 114. Available at: http://www.quackwatch.org/01QuackeryRelatedTopics/OTA/ota05.html

………………………….

The State Regulation Series:

  1. Pitfalls in Regulating Physicians. Part 1
  2. Pitfalls in Regulating Physicians. Part 2: The Games Scoundrels Play
  3. The Pseudomedical Pseudoprofessional Organization (PPO*)
  4. A New Twist for Autism: A Bogus “Biomedical” Board
  5. How State Medical Boards Shoot Themselves (and You) in the Foot
  6. “Integrative Medicine Experts”: Another Barrier to Effective Discipline
  7. Bogus Diagnostic Tests 

Posted in: Health Fraud, Politics and Regulation, Science and Medicine

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