http://www.cbsnews.com/stories/2007/11/13/cbsnews_investigates/main3496471.shtml

dysfunction of these veterans is seemingly inexplicable due to the failure to diagnose and treat early. This scenario is remarkably similar to the legacy of Vietnam veterans.

As a clinical and academic physician who is integrally involved with the treatment of members of the pan-military 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. In-depth interviews, detailed physical examinations, and HBOT treatment of nearly 40 of these veterans exposed to concussive blasts has revealed significant abnormalities in those patients with loss of consciousness. These abnormalities have been supported by psychological evaluations, cognitive testing, and functional brain imaging abnormalities that are consistent with the diagnoses of “TBI” and “PTSD” bestowed by military evaluators.

Our efforts continue 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, scientific 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 FDA-approved drug that is known to be a non-specific biological repair therapy for acute and chronic wounds. No wound can heal without oxygen, and oxygen CAN NEVER BE A PLACEBO. Oxygen is used directly or indirectly in nearly all cellular processes and when elevated to hyperbaric doses oxygen has been documented to have the added benefit of activating DNA to transcribe growth and repair hormones. 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 that is defined by loss of consciousness.

HBOT is the only non-hormonal FDA-approved treatment known to repair and regenerate human tissue. HBOT repairs and regenerates tissue by two oxygen-dependent processes, the activation of growth factors at a DNA level and the improvement of blood supply to wounds. These salutary effects of hyperbaric oxygen apply in a variety of FDA-approved indications such as the acute wounds of traumatic loss of blood supply, traumatic hemorrhage, crush injury, and a number of neurological injuries. These effects also apply in FDA-approved conditions with chronic wounds such as diabetic foot wounds, radiation wounds, and chronic bone infections. The salutary effects of HBOT apply regardless of the location of the wounds in the body. As a result, HBOT can be considered a generic drug for repair of acute and chronic wounds in the body.

Since 2003, numerous peer-reviewed articles have been published that demonstrate hyperbaric oxygen treatment is effective at repairing the injured brain, even years after injury. The most recent report in blast injured veterans was presented at the 8th World Conference on Brain injury in Washington, D.C. on March 12, 2010. On average, using only half of the HBOT 1.5 protocol, blast-injured war veterans experienced 15 point IQ increases (p<0.001) (the difference between a high school graduate and an engineer), 40% reduction in post-concussion symptoms [p=0.002 (np)], 30% reduction in PTSD symptoms (p<0.001 ), and a 51% decrease in depression (p<0.001). The magnitude of these changes was striking, not previously seen with any other therapy for our veterans, yet consistent with past published reports of HBOT in chronic brain injury, including research by the military on brain-injured children. These results were accompanied by functional brain imaging that showed an improvement in brain blood flow. The fact that statistically significant results were reported with only 15 patients was remarkable. More importantly, these preliminary study results were measured by an independent licensed neuropsychologist and a radiologist and were consistent with treatment results from the other 13 FDA-approved HBOT indications.

Fortunately, we have a cost-effective solution to the current lack of effective treatment for veterans with TBI that may also impact their PTSD and suicide epidemic. As an alternative to the use of FDA Black Box labeled drugs I would like to suggest the immediate approval of HR 4568, "the TBI Treatment Act," with an expansion of the $10 million for which the pilot is currently approved. The International Hyperbaric Medical Foundation through its National Brain Injury Rescue and Rehabilitation Project (N-BIRR) has a national IRB-approved study that is poised to treat 1,000 veterans at 14 sites, with more sites joining each month. The only impediment to activation at existing sites and expansion of HBOT 1.5 at more treatment centers is reimbursement for those who show a positive response to treatment.

Costs must be taken into consideration. If hyperbaric oxygen therapy were charged at the average CMS-set civilian rate of $200 per treatment, the cost per casualty would be $16,000. If the military treated these members themselves, it would cost a maximum of $50 per treatment ($35 labor and $15 for oxygen) or $4,000 per casualty. Compare these costs to the cost of getting a new E-1 to join the service ($20,000), to get that E-1 through the lowest-cost basic training and advanced course ($155,000), the value of an NCO ($500,000), the value of an officer ($750,000), a SOCOM member or pilot ($5 million), and the cost savings from biologically repairing an injured veteran become pretty clear. According to the RAND report, the annual ongoing costs per year of the current treatments for mild-TBI is about $32,000. A one-time cost between $4,000 and $16,000 is much less expensive than current practices.²

In addition to the application of HBOT 1.5 for chronic brain injury we would like to advocate for HBOT 1.5 in acute severe traumatic brain injury. A few HBOT 1.5 treatments within hours of injury, can change military casualty care immensely. Acute treatment in severely brain-injured patients, for example, has been shown in multiple randomized trials to decrease mortality by 59%, the largest reduction in mortality since the invention of the ambulance, the use of helicopters in Vietnam for battle casualties, and penicillin for infection.

Due to medical politics, physicians ignored this science and prevented the adoption of HBOT 1.5 in June, 2001, three months before 9/11 initiated the battle casualties that continue today. Because of his personal experience with HBOT 1.5, I would like to recommend to the Committee that Colonel Virgil Deal, M.D., the Surgeon General for SOCOM, should be put in command of a team that would bring this treatment to the battlefield as quickly as possible. His position is independent of the Surgeon Generals of the other branches of the military. Military commanders sent a 10-liner and have asked for hyperbaric equipment and treatment in the field. That request was rejected by military medicine because military medicine repeats the myth and mantra that there is no evidence for HBOT. The British, the Russians, the Serbs and the Israelis have all successfully applied hyperbaric medicine to combat causalities. In 2009, we proposed to Chairman Murtha the same treatment for

² RAND Report: “Invisible Wounds of War: Psychological and Cognitive Injuries, Consequences, and Services to Assist Recovery.” Tanielian, Terri; Jaycox, Lisa, April 2008, page xxii-xxiii: Two year costs within the first two years the service member returns home; PTSD $5,904 to $10,298 depending on whether we count the lives lost to suicide; Two year costs for major depression, $15,461 -$25,757; co-morbid PTSD and major depression; $12,427 to $16,884; One year costs for traumatic brain injury diagnosis: $25,572 to $30,730 in 2005 for mild cases ($27,259 to $32,759 in 2007 dollars), and $252,251 to $383,221 for moderate or severe cases ($268,902 to $408,519 in 2007 dollars.) These costs, largely treating symptoms, continue to have outyear costs and outyear consequences in terms of disability payments, inability to work, etc. Given that the HBOT ONE TIME cost for service members who need all 80 treatments averages $16,000 at Medicare Reimbursement rates for a 1 hour treatment. (The cost is lower in some states and higher in urban areas, with known rates set by CMS.) Hyperbaric medicine alone, and hyperbaric medicine in conjunction with other treatments, is very cost effective. If provided acutely within hours of injury, the treatment is even more effective and massively more cost effective.

our Afghanistan casualties with the High Altitude Mortality Reduction (HAMR) program. We believe the time has come to bypass the obstructions to deployment of this life and quality of life-saving treatment and institute this therapy immediately for our injured warriors. We further believe that when physicians entrusted with the care of these wounded men and women ignore scientific evidence for irrational reasons congress must act to override their arbitrary decisions.

We look forward to a future hearing when we can present the evidence in person and place before you for your questioning brain-injured veterans who have received the benefits of HBOT 1.5. Among them will be General Patt Maney (retired) who was the first U.S. battle casualty to receive HBOT 1.5 for his blast-induced brain injury in Afghanistan.³ His treatment was ordered after 9 months of therapy at Walter Reed had shown minimal improvement. As a result of his injuries he was non-functional and unable to return to his job, let alone redeploy to Afghanistan. He received the protocol I developed, completely without my involvement, at George Washington University Medical Center. After treatment he was discharged from Walter Reed and returned to his civilian job as a Florida state judge. Yes, a Florida State Judge.

Unfortunately, Tricare will not reimburse for HBOT 1.5 for brain injury, even when the therapy has been successful. Instead, the cost of treatment has been borne by the clinics and doctors who have treated these needy veterans or paid for by military charities. Meanwhile, the DoD is reimbursing for off-label use of FDA Black Box labeled drugs that have been implicated in the marked suicide rate in our injured veterans. These drugs mask symptoms or act as chemical restraints, leaving untouched the underlying brain injury that is repaired by HBOT 1.5. We 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. Please add HR 4568 to the Senate Armed Services bill and make sure that successful treatments are funded.

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
Vice President, International Hyperbaric Medical Association
President, International Hyperbaric Medical Foundation

³ The first battle casualty, a U.S. Army Reserve General, blown up in Afghanistan, was treated with HBOT 1.5 while a patient at Walter Reed Army Medical Center. He received treatment from George Washington University Medical Center at the Tricare Reimbursement rate of $250 per treatment. He spent months at Walter Reed making no progress. Counting lost time and hospital costs in the Army Accident pamphlet, his months at Walter Reed cost DoD $400,950, with a permanent disability loss to the service of $1.3 million. With HBOT 1.5 earlier, he would have been able to remain on active duty, a savings of $1.3 million, but more importantly, the 5 months of recovery once he began receiving HBOT 1.5 cost $133,650, a savings to the government of $287,300. No other patients were treated at Walter Reed's brain injury center, despite the General's remarkable recovery that everyone on the staff witnessed. The $20,000 for his hyperbaric medical treatment was more than justified.

Cover Sheet for Appendix to Letter from Paul Harch, M.D. to the Senate Armed Services Committee Hearing, Tuesday, June 22, 2010.

There is no drug currently approved by the FDA to treat TBI. The only drugs approved for PTSD are Zoloft and Paxil. All other treatment with drugs for these conditions is off-label and intended to treat symptoms. Therefore the DoD Secretary's Hearing statement to Congressman Jones at the House Armed Services committee hearing in 2009 that DoD is not paying for any off-label treatment continues to be inaccurate. In fact, a significant percentage of psychiatric medications are prescribed off-label. Further, the use of antipsychotics in these patients is often as a chemical restraint.

The following list of drugs are FDA approved for psychiatric and neurologic disorders. The great majority of these drugs have been and are currently prescribed by DoD Medicine off-label for TBI/PTSD in the service members Dr. Harch has treated with HBOT 1.5 in New Orleans.

The attached pages describing drug risks have been extracted from the Physicians Desk Reference. Note that a number of them are black labeled by the FDA for causing increased suicidality in patients 24 and under.

Note: The official DoD White Paper for the December 2008 HBOT in TBI Consensus Conference states, “Side effects from HBOT are uncommon, and severe or permanent complications are rare, especially at the doses of HBOT used “off-label” for TBI patients (approximately 1.5 atm abs for 60 minutes.), compared to HBOT for HHS covered indications (2 to 2.4 atm abs for 120 to 90 minutes.)” ⁴ For the mild traumatic brain injury patient, clinical experience demonstrates this treatment is far less risky to patients than leaving them untreated. It is also less risky than being in Iraq or Afghanistan.

⁴ DoD “HBOT for TBI” Consensus Conference White Paper, 28 October 2008

International Hyperbaric Medical Association 8210 Cinder Bed Road, Ste C-3, Lorton, Virginia 22079-1135

• Page 8 June 22, 2010

In addition to the increased risk of suicide with these drugs there is also a risk to abrupt withdrawal. This is a special problem for those departing the service. They often have problem getting prescriptions refilled by the VA in a timely manner, and are at higher risk of suicide as a result. Further, there is a risk to driving while medicated and ingesting alcohol (a frequent problem with post-combat veterans, and one that has resulted in UCMJ action, and dishonorable discharges of decorated war veterans):

There is a Risk to abrupt withdrawal with the following drugs:

a) (Almost any SSRI antidepressant or sedative drug): Discontinuation of Treatment with Zoloft: During marketing of Zoloft and other SSRIs and SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.

Patients should be monitored for these symptoms when discontinuing treatment with Zoloft. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.

b) Benzodiazepines -clonazepam, valium

Risk to driving while medicated and ingesting alcohol:

Sedative (DWI) Risk: all drugs except Wellbutrin, SSRIs, Adderall, Ritalin, Provigil, etc

International Hyperbaric Medical Association 8210 Cinder Bed Road, Ste C-3, Lorton, Virginia 22079-1135

4/15/2010

Case Report: Navy SG Meeting -Aug. 2008

25 year old Humvee Machine Gunner
6 IEDs-1 RPG hit in Two Tours in Iraq

40 HBOT 1.5 treatments (1/2 of the Protocol)

From living in a dark room, unable to go to the Mall because of PTSD, after HBOT 1.5 treatments his PTSD cleared, he turned down ½ of the offered VA disability, worked for a year, and after 40 more treatments has returned to college.

HBOT 1.5 Restores Brain Blood Flow & Doubles Metabolism

Marine Machine-gunner -August 2008 Navy SG Briefing

Scale actually goes from 0 to 2000 so it ENDS at 2000. Those pixels that are hitting near 2000 are red and are the most active, the less metabolically active are "cooler" colors of yellow, green and blue. So if you draw a line across the middle of the scale you can see what pixels are registering at 1000 by the corresponding color.

Both pre and post HBOT sets of images are exactly on the same scale. Below is a quantitative assessment that shows the actually percent increase in up take to an area of the brain quite vulnerable to TBI. Note the mean uptake in the area went from 644 to 1008. Similar changes are evident everywhere else.

A change from green to red is a doubling of metabolism.

Analysis of blast injured veteran in LSU IRB Study # 7051: Edward Fogarty, MD, Neuro-radiologist, Chair, University of North Dakota School of Medicine, (701) 751-9579

www.HyperbaricMedicalAssociation.org

Drugs Being Prescribed for PTSD and TBI Patients