Hyperbaric Medicine Officially Enters the Prohibition Era

An article specifically written for ”Hyperbaric Medicine Today”
in their “Physicians’ Forum Counterpoint” feature.
From Volume 1 Issue 1
Research in Hyperbaric Medicine by Dr. Eric P. Kindwall

Dr. Paul G Harch writes:

The Physicians' Forum article in the inaugural issue is a comprehensive discourse with many good points on the legality of off-label HBOT, research funding, a registry, recommendations for patients seeking off-label treatment, and standardized testing/documentation. However, these points are nearly lost in an extremely confusing, obfuscating tangle of terms definitions, and concepts that is partly based on a double standard. Despite the confusion, the message and threat to the entire hyperbaric medicine community was transmitted so loud and clear in the final paragraph that I was moved to declare this the “Prohibition Era Of Hyperbaric Medicine” It appears that the purpose of the article is to alter the historical method of the practice of medicine and hyperbaric medicine by jeopardizing a physician's membership in a medical society should they dare to use HBOT for an off-label indication.

The article begins with a comment on “evidence-based medicine”' and then proceeds to speak about peer-reviewed, randomized, prospective, controlled, double-blinded trials (RCPT's) to assess validity of scientific information. The double standard in these two paragraphs can be appreciated in the 1996 approval of intracerebral abscess (ICA), (cerebral abscess, subdural empyema, and epidural empyema) by the Hyperbaric Oxygen Therapy Committee to the accepted indications list. The argument in the 1996 HBOT Committee Report was based on thirteen cases treated off-label, ten of which were published in the Journal of Hyperbaric Medicine, 1989. These were combined with six cases generated after years of open solicitation from an influential HBOT Committee member to any UHMS physician who had treated cerebral abscess with hyperbaric oxygen. These last six cases are strongly biased since very few physicians are willing to volunteer a personal/professional failure, i.e., a hyperbaric oxygen treated cerebral abscess case that died. The mortality from these twenty cases was compared to the latest figures, 1991, on the historical declining mortality rate in cerebral abscess to achieve statistical significance and approve cerebral abscess as an accepted indication. To summarize, the accepted indication, cerebral abscess, is a diagnosis composed of three separate diseases, based on twenty non controlled cases, none of which appear to be on an JRB-approved protocol, all of which were apparently treated off-label, only ten of which are in a peer reviewed journal, six of which are highly biased, non-published solicitations and the argument for which is based on a comparison to a historical declining mortality rate. Regardless of the strong pathophysiological argument this is weak science, especially when compared to data discussed below. To subsequently argue, in the Physicians' Forum article's lead paragraph for evidence-based medicine from randomized prospective controlled research published in peer-reviewed journals as an intro and backdrop to a critique of HBOT/cerebral palsy and off-label use of HBOT, is a double-standard.

The double standard is more apparent in the article's review of HBOT cerebral palsy data. The article disparages the hyperbaric oxygen treatment data of cerebral palsy children by labeling it "anecdotal." This "anecdotal" experience includes six reports: 240 "anecdotal" cases by Machado, a single "anecdotal" case reported by me in 1994 (the first cerebral palsy case treated with HBOT in North America), three "anecdotal" cases reported by Dr. Neubauer and me at a hyperbaric meeting in Buenos Aires in 1996, an additional "anecdotal" case reported by Neubauer and me in the Third Edition of K.K. Jain 's Textbook of Hyperbaric Medicine in July/99, 18 "anecdotal" predominantly IRB cases reported by me at the Boca Raton July 1999 Conference, and now 25 IRB "anecdotal" cases reported by Montgomery at McGill in 1999. While a number of the above reports are abstracts, three of the studies (Machado, Harch, and Montgomery) are prospective and controlled (each patient serving as his own control). The Montgomery study also used blinded examiners and was published in a peer reviewed journal. This constitutes greater experience for HBOT treatment of cerebral palsy than for the nineteen "anecdotal" HBOT/ICA cases which generated inclusion on the accepted indications list in 1996. To disparage the evidence for HBOT/CP is inconsistent.

Professor Keith Van Meter, MD / Chief of Emergency Medicine, LSU Health Sciences Center - New Orleans School of Medicine talks about the early days of Dr. Harch's medical career.

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Paul G Harch M.D. has long been considered a pioneer in hyperbaric medicine research and clinical applications. Author of The Oxygen Revolution, Dr. Harch has written numerous articles on Hyperbaric Oxygen Therapy (HBOT) and has had several writings published in major medical journals. Dr. Harch was responsible for the scientific argument and application to Medicare that resulted in the approval of hyperbaric oxygen treatment of diabetic foot wounds.  Based on Dr. Richard Neubauer’s work and in conjunction with Dr. Van Meter he has developed many of the accepted protocols for HBOT in neurological disorders, including chronic traumatic brain injury (TBI) and Post Traumatic Stress Disorder (PTSD) in our military veterans.