Timeline of IHMA 's original submission and subsequent actions to get Diabetic Foot Ulcers approved. This landmark decision was important because this is the first new indication to be added by Medicare for HBOT in over 18 years. This means more hyperbaric clinics opening across the nation, needless amputations have been significantly lowered, and is an important building block for other hyperbaric indications to be recognized and added for treatment and insurance reimbursements.
The International Hyperbaric Medical Association has worked extensively with government regulatory bodies including the Food and Drug Administration and the Centers for Medicare and Medicaid Services - the IHMA's efforts allowed diabetic foot wounds to be approved as the first new indication for hyperbaric oxygen in 18 years- 2003
POSITIVE EFFECTS OF HYPERBARIC OXYGENATION IN CERTAIN MITROCHONDRIAL CYTOPATHIES
“All life takes place on a cellular level. This is the first scientific proposal that hyperbaric oxygenation may selectively turn mitochondrial genes on and off.”
- Richard A. Neubauer, M. D.
The simplest life on earth, as we know it, occurs in cells. Over the millennia, as cells evolved into more complex organisms, the new life depended upon the integrated and coordinated activities of thousands, millions and even billions of cells, each one requiring appropriate oxygen and glucose for respiration, metabolism, production of energy, adaptation, reproduction and overall survival.
For cells to carry out their unique functions they require a variety of foods with which to build their various cellular structures as well as their unique proteins, lipids and carbohydrates and from which the cells extract the energy to carry on all their vital activities.
The energy is derived in a series of biochemical reactions which involves the burning of sugar (glucose) in the foods animals eat with the oxygen they breathe. Normally when animals living on land, including humans, take a deep breath they inhale air containing 19-21% oxygen. From here on we will limit the discussion to humans, keeping in mind that similar activities, with variations in the details, also occur in other living organisms, especially mammals, the group of organisms to which humans belong.
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.
Retired NFL 49'er, George Visger shares his story before getting a visit from an old teammate. BRAIN STORM: OXYGEN TREATMENT 4
Retired NFL San Francisco 49'er, George Visger shares his story in the media before getting a visit from an old teammate.
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.
BRAIN STORM: OXYGEN TREATMENT Episode 3
L.A. City Films
Paul Harch MD Receives the Lifetime Achievement Award from IHMA, BRAIN STORM Oxygen Treatment Episode 2
L.A. City Films Production
HBOT2012 International Symposium video of Philip James, MD, Paul Harch, MD & key speakers
Long Beach CA
BRAIN STORM: OXYGEN TREATMENT Episode 2
L.A. City Films Production
This video series Brain Storm: Oxygen Treatment, inspired by the book “The Oxygen Revolution” (authors Paul G. Harch MD & Virginia McCullough) and the new book “Oxygen and the Brain, The Journey of Our Lifetime” (author Philip James, MD) was filmed on location at the HBOT2012 International Symposium in Long Beach CA August 9-12 and is an L.A. City Films production.
In this first episode, Dr. Philip James talks about how a traumatic brain injury is like a brain storm. Whereas low atmospheric pressure can bring on a powerful storm, the low blood flow resulting from brain injury causes neurological symptoms and cognitive impairment.
Oxygen and The Brain, Dr. Philip James Explains This Relationship in His New Book
L.A. City Films Production
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.