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Dr Paul Harch's Testimony HASC For The Record, FDA Approval of HBOT for Traumatic Brain Injury

In May 2009, Congressman Jones brought up HBOT 1.5 to the Secretary of Defense and the Chair of the Joint Chiefs of Staff at the House Armed Services Appropriations Hearing. The Secretary stated that HBOT 1.5 was not being paid for because it was not FDA approved (even though every active duty veteran treated has been able to return to duty.) Dr. Harch has sent this response to the committee.

TESTIMONY FOR THE RECORD: Regarding FDA approval of Hyperbaric Oxygen Therapy (HBOT) to treat traumatic brain injury (TBI), off-label prescription drug use by the Department of Defense for TBI and post-traumatic stress disorder (PTSD), and the potential relationship of this drug use to the incidence of suicides in United States Service members. The National Brain Injury Rescue and Rehabilitation Project continues to reaffirm the biological nature of blast-induced brain injuries incurred by coalition forces in Iraq and Afghanistan . Fortunately, preliminary evidence at multiple centers suggests that these TBI war casualties respond to a low pressure protocol (HBOT 1.5) of Hyperbaric Oxygen Therapy.  HBOT uses oxygen as an FDA-approved drug and is known to be a non-specific biological repair therapy for acute and chronic wounds. HBOT is the only FDA-approved treatment known to biologically repair and regenerate human tissue and activate growth factors at a DNA level. It is FDA-approved to treat conditions like blunt trauma, crush injury and non-healing wounds. Three of the 13 FDA-approved indications are for neurological injury. Physicians are permitted to use an approved drug or device “off-label” when they believe the underlying mechanisms of action may help a patient with a non-approved condition.

The statement has been made that “HBOT is not FDA approved for brain injury” and that is why Tricare and VA are not paying for this therapy. While true, this does not tell the whole story. In fact NONE of the drugs currently being used and paid for by Tricare and the VA are FDA-approved to treat TBI. Only two, Paxil and Zoloft, are approved to treat PTSD. Both of those carry FDA Black Box warnings urging caution in 17-24 year olds because of the increased risk of suicide of these medications in this age group. Some of my military patients in this age group have reported to me they were threatened with UCMJ action if they failed to take these drugs, even though they were in the known risk group.

An article was published in The Army Times about the HAC-D committee’s (and all Americans’) concern over the high rate of suicides in our veterans and the lack of effective treatment for TBI and PTSD. With respect to the suicide epidemic I would like to suggest to the committee that they investigate as a causative factor the high rate of off-label usage of the multitude of psychoactive drugs currently prescribed to modulate the symptoms of TBI and PTSD. (See appendix for list and side effects listed in the Physicians Desk Reference.)

Many of these casualties have been able to return to duty, work or school. Their post-concussion syndrome has improved clinically. Standardized independent neuropsych tests like IQ or ANAM, and PTSD standard questionnaires have all shown improvement. Functional brain imaging of whatever type has shown repair of the neural structures and function within the brain. No wound can heal without oxygen. In fact, the functional imaging demonstrates the brain responds to HBOT 1.5 just like any other non-healing wound area in the body. The FDA has approved HBOT for treating non-healing wounds. Tricare and many third party payers reimburse for HBOT non-healing wound treatment. Fortunately, the N-BIRR team has already saved DoD $6.3 million in recruiting and retraining costs by returning five veterans to duty at a civilian treatment cost of $62,500. 

Unfortunately, Tricare has not chosen to reimburse for HBOT 1.5, even when the therapy saves the government money by restoring an individual service member to duty. Instead, much of this cost has been borne by the doctors who have treated our veterans at their own expense. DoD is only reimbursing for drugs that mask symptoms or act as chemical restraints. They also pay for counseling that while helpful, does not treat the underlying cause of the changes in combat veteran’s behavior resulting from a biological injury. I urge the committee to encourage the Department of Defense to apply a reasonable reimbursement standard to the only FDA-approved treatment that biologically repairs non-healing wounds, Hyperbaric Oxygen Therapy."

Testimony submitted by Paul G Harch, MD: May 15, 2009

Ike Skelton, Chairman

John M. McHugh, Ranking Member

House Armed Services Committee

United States House of Representatives

Washington, D.C. 20515

TESTIMONY FOR THE RECORD: Regarding FDA approval of hyperbaric oxygen therapy (HBOT) to

treat traumatic brain injury (TBI), off-label prescription drug use by the Department of Defense for TBI and post-traumatic stress disorder (PTSD), and the potential relationship of this drug use to the incidence of suicides in United States Service members.

Dear Chairman Skelton & Ranking Member McHugh:

As a clinical and academic physician who is integrally involved with the treatment of members of the panmilitary epidemic of U.S. servicemen afflicted with traumatic brain injury (TBI), post-traumatic stress disorder (PTSD), and depression I feel compelled to offer information that may contribute to the solution of these vexing problems. Careful questioning of over 30 veterans and in-depth interviews with detailed physical examinations of 19 of these veterans exposed to concussive blasts has revealed significant abnormalities in those patients with loss of consciousness from their blast exposure. These abnormalities have been supported by psychological and cognitive testing abnormalities that are consistent with the diagnoses of “TBI” and “PTSD” bestowed by military evaluators.

The National Brain Injury Rescue and Rehabilitation Project continues to reaffirm the biological nature of blast-induced brain injuries incurred by coalition forces in Iraq and Afghanistan. In the last 40 years scientific research has documented loss of brain tissue in individuals who have experienced traumatic loss of consciousness from mild-moderate TBI. While the majority of these individuals “recover” from their injury they are not “normal.” There is a true “signature” of the injury that remains in the brain and which can be elicited by stress conditions.

Fortunately, preliminary evidence at multiple centers suggests that these TBI war casualties respond to a low pressure protocol (HBOT 1.5) of hyperbaric oxygen therapy. This treatment uses oxygen as an FDAapproved drug and is known to be a non-specific biological repair therapy for acute and chronic wounds. Congruent with past reports in the medical literature, where the same or a similar protocol has been given to patients with chronic post-concussion syndrome from TBI of non-blast causes, these veterans are showing improvement with HBOT 1.5. This response supports the argument that there is a biological injury/scar in the brain from blast-induced TBI characterized by loss of consciousness. HBOT is the only FDA-approved treatment known to biologically repair and regenerate human tissue and activate growth factors at a DNA level. It is FDA-approved to treat conditions like blunt trauma, crush injury and non-healing wounds. Three of the 13 FDA-approved indications are for neurological injury.

Physicians are permitted to use an approved drug or device “off-label” when they believe the underlying mechanisms of action may help a patient with a non-approved condition. The statement has been made that “HBOT is not FDA approved for brain injury” and that is why Tricareand VA are not paying for this therapy. While true, this does not tell the whole story. In fact NONE of the drugs currently being used and paid for by Tricare and the VA are FDA-approved to treat TBI. Only two, Paxil and Zoloft, are approved to treat PTSD. Both of those carry FDA Black Box warnings urging caution in 17-24 year olds because of the increased risk of suicide of these medications in this age group. Some of my military patients in this age group have reported to me they were threatened with UCMJ action if they failed to take these drugs, even though they were in the known risk group. An article was published in The Army Times about the HAC-D committee’s (and all Americans’) concern over the high rate of suicides in our veterans and the lack of effective treatment for TBI and PTSD. With respect to the suicide epidemic I would like to suggest to the committee that they investigate as a causative factor the high rate of off-label usage of the multitude of psychoactive drugs currently prescribed to modulate the symptoms of TBI and PTSD. (See appendix for list and side effects listed in the Physicians Desk Reference.)

As stated previously, many of these drugs have black box warnings of increased rates of suicides, specifically the more modern antidepressants. The actual FDA warning reads, “Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of (insert name of antidepressant) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24…”

The age group described by this warning would seem to include a significant number of our brain-injured veterans. Use of most of these drugs long term also results in a loss of a security clearance, which for many of these personnel, effectively ends their military careers. As an alternative I would like to suggest the expansion of off-label usage of another FDA-approved drug with a far safer profile, hyperbaric oxygen therapy. This therapy does not result in a loss of a security clearance for active duty personnel. In the past 20 years I have extensively and successfully applied a lower dose of hyperbaric oxygen therapy (HBOT 1.5) to a wide array of neurological diagnoses, including TBI. Twenty-three cases in this experience have been presented to a House Appropriations Subcommittee and House Government Oversight Committee on three separate occasions in 2002 and 2004. While we expected clinical and cognitive improvements in these casualties, our recent surprise in treating braininjured veterans was an improvement in PTSD symptoms in a significant number of these patients.

The protocol I have developed has now been successfully applied by other physicians (please see the N-BIRR Scorecard submitted to you by Dr. William Duncan) and has been duplicated in an animal model that I published two years ago. The safety profile with this drug (HBOT 1.5) and protocol is extremely safe and carries no FDA black box warning. Further experience is in process through a formal pilot trial that I amconducting at LSU School of Medicine, New Orleans. The Scorecard contains some of those results. Many of these casualties have been able to return to duty, work or school.

Their post-concussion syndrome has improved clinically. Standardized independent neuropsych tests like IQ or ANAM, and PTSD standard questionnaires have all shown improvement. Functional brain imaging of whatever type has shown repair of the neural structures and function within the brain. No wound can heal without oxygen. In fact, the functional imaging demonstrates the brain responds to HBOT 1.5 just like any other non-healing wound area in the body. The FDA has approved HBOT for treating non-healing wounds. Tricare and many third party payers reimburse for HBOT non-healing wound treatment. In addition, the recent Institutional Review Board approval of the national N-BIRR protocol enables practitioners from across the nation to begin treating with HBOT 1.5 and track and publish those results.

The scientific information from these studies will be of appropriate scientific rigor to allow the application for FDA-pre-market approval for use of HBOT for TBI and PTSD. Since there is no patent on oxygen, the funds simply have not been available to acquire level I evidence previously. Now, seven years into the war, we are seeing the results of untreated brain injuries throughout society. We have about 154,000 homeless war veterans, a rising percent of our jail population is comprised of recent veterans, and the all volunteer Army has been strained by readiness and retention challenges. Fortunately, the N-BIRR team has already saved DoD $6.3 million in recruiting and retraining costs by returning five veterans to duty at a civilian treatment cost of $62,500.

Unfortunately, Tricare has not chosen to reimburse for HBOT 1.5, even when the therapy saves thegovernment money by restoring an individual service member to duty. Instead, much of this cost has been borne by the doctors who have treated our veterans at their own expense. DoD is only reimbursing for drugs that mask symptoms or act as chemical restraints. They also pay for counseling that while helpful, does not treat the underlying cause of the changes in combat veteran’s behavior resulting from a biological injury. I urge the committee to encourage the Department of Defense to apply a reasonable reimbursement standard to the only FDA-approved treatment that biologically repairs non-healing wounds, Hyperbaric Oxygen Therapy.

Thank you for your attention.

Sincerely,

Paul G. Harch, M.D.

Clinical Associate Professor,

Director of the Hyperbaric Medicine Department

LSU School of Medicine, New Orleans

 

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