Write Congress Today!

Dear Senator/Representative: (The correct name will be added in here):

A pathway is needed to quickly get effective treatment for traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) to our injured war veterans. TBI is a physical injury to the brain that often produces psychiatric-like symptoms such as depression, impulse control issues, etc. PTSD may be purely emotional in nature or may also have a physical injury component. PTSD and TBI share many symptoms making it to differentiate between them based on symptoms alone. Sadly, current treatment practices in our military communities treat both diagnoses with therapies developed for purely psychiatric conditions. That is like counseling to a person with a compound fracture of a leg to not walk on it. The leg needs to be set and splinted. Similarly, when a brain is injured such as by exposure to blast and/or high levels of life-threatening stress it needs physical repair. Once that is accomplished, existing psychiatric tools, if still needed at all, work much better.

The civilian world has developed effective treatments for TBI and PTSD, yet there is no pathway currently available to speed deployment of these treatments into DoD or VA medicine. A possible such pathway has been developed and is being considered by the United States Senate this week as part of S. 1867, "National Defense Authorization Act for Fiscal Year 2012" (NDAA). This provision is the "TBI Treatment Act," H.R. 396. This provision has been endorsed by the Brain Injury Caucus and many veterans groups. It would require DoD and VA to pay for treatment for a brain injury only when it works for a given veteran. This language is already contained in the House NDAA bill as section 731 of H.R. 1540. It has been reported to us that Senator Inhofe is planning to offer this provision as an amendment to S. 1867. We ask for support of the Inhofe Amendment and support for House section 731 in Conference for the NDAA.

Despite Congress providing billions to the government's medical bureaucracy to find effective treatments for TBI and PTSD, today's war veterans with those injuries are not significantly closer to being able to receive effective treatment than they were when the war started. There may be over 700,000 of these veterans now in the civilian sector, and the presence of those numbers is being reflected in the figures for veteran unemployment, homeless and incarceration. Further, one recent article in Military Medicine reported that as much as 40% of the current active duty force may have these kinds of injuries.

On July 21, 2010, the House Veterans Affairs Committee heard from many civilian physicians and practitioners that there is more that can be done. Real treatments that dramatically improve patient outcomes were described. However, the trail-blazing civilian practitioners could not get paid for their treatments, even in the face of extensive clinical experience and published data that they were effective. Meanwhile, the House VA committee was told that an untreated brain injured veteran costs society, on average, about $60,000 per year for incarceration, lost productivity, health care and other expenditures. Instead of effective treatment, the DoD and VA medical establishments continue to spend hundreds of millions of dollars for drugs for TBI or PTSD symptoms, without the same level of research evidence or safety considerations being required for more effective and available treatments. Many of these currently prescribed drugs are black-labeled by the FDA as increasing the risk for suicide. This may help explain why in the two current wars it appears that we have lost more service members to suicide than to combat.

The TBI Treatment Act will help spur translational medicine, the practice of moving bench science discoveries into clinical practice. The bill requires the VA or TRICARE to pay for ANY treatment for traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD) that WORKS. It requires payment to be made within 30 days to any treatment facility that 1) provides a treatment using an already FDA approved drug or device; 2) follows an IRB-approved protocol; 3) and can demonstrate improvement by means of standardized independent pre-treatment and post-treatment neuropsychological testing, accepted survey instruments, neurological imaging or clinical examination. The legislation also requires payment for diagnostics. Thus, diagnostics like Functional 3CT MRI, developed by Dr. Haake at Wayne State University in Michigan, will also be paid for through this legislation. This will permit imaging to be brought to bear that is 100x more effective than anything previously available for brain diagnostics and research, and will enable those technologies to be used to verify the results of the treatments under the TBI Treatment Act. The legislation does not mention any specific treatment. Some of the treatments that could be paid for include cognitive rehabilitation which was used to help Congresswoman Giffords recover to her current level. Another currently unreimbursed treatment developed by the International Brain Research Foundation in New Jersey awakens those in a coma over 80% of the time, saving many thousands of dollars for these patients. The TBI Treatment Act would also include hyperbaric oxygen therapy (HBOT). HBOT when delivered at 1.5 atmospheres in accordance with a well-tested protocol has caused nearly all of the veterans recently treated to have significant improvements. Veterans' TBI and PTSD symptoms have resolved or been significantly improved.

Hyperbaric oxygen therapy has been requested for veterans by Commanders and Veterans Service organizations alike. General Conway, when Commandant of the Marine Corps, reported to the House Armed Services Committee about sending some of his most injured Marines to Dr. Harch in New Orleans to receive Hyperbaric treatment. General Chandler, as Vice Chief of Staff of the Air Force requested Chairman Levin provide hyperbaric treatments to his Airmen in the SASC hearing on Suicide in 2010, and Chairman Levin agreed. The American Legion asked for this treatment in their Senate testimony last year. The TBI Treatment Act is the only provision in the Senate Armed Services bill that will permit the Chairman to keep his pledge to General Chandler, and does so in real time.

HBOT is the only non-hormonal biological repair and regeneration treatment approved by the FDA. The latest HBOT 1.5 TBI/PTSD peer-reviewed and published results (Journal of Neurotrauma, October 25, 2011) are remarkable. Those results are from the first 15 persons treated under a pilot trial funded in large measure by the Semper Fi Funds and the Coalition to Salute America's Heroes. On average, using only half of the recommended HBOT 1.5 protocol (as used in the NBIRR-01 study sponsored by the International Hyperbaric Medical Foundation (IHMF)), blast-injured war veterans experienced an average 14.8 point IQ increase from post-injury to post-HBOT 1.5 treatment (p<0.001) (the difference between a high school drop-out & a college graduate) and an average 39% reduction in post-concussion symptoms [p=0.0002 (np)] with 87% reporting a substantial headache reduction. Study subjects also reported a 30% reduction in PTSD symptoms (p<0.001), and a 51% decrease in depression scores (p<0.001) with a concurrent substantial reduction in suicide ideation. Further, the improvements have been found to be lasting. Based on clinical experience and NBIRR-01 results to date, further treatment for these patients would be expected to further improve these outcomes. Medication costs for study subjects were reduced with 64% reporting a reduced need for psychoactive or narcotic prescription medications. Most subjects have been able to return to duty, work or school. There has been consistency across physicians whenever the correct protocol has been followed.

These Journal of Neurotrauma reported results have been further validated in the IHMF's ongoing NBIRR-01 study (NCT01105962 registered at www.clinicaltrials.gov.) This multi-center study, with over a score of sites across the nation, uses several neurocognitive tests, including ANAM and CNS-Vital signs, as well as the DoD/VA accepted survey instruments for PTSD, Post-Concussion Syndrome, depression, health status and quality of life. Contrary to recent media reports, the IHMF's preliminary findings have validated DoD's ANAM as an accurate assessment of cognitive change. Where pre-deployment ANAM baselines were available, post-injury scores accurately reflected that cognitive change had occurred. As HBOT treatment progressed, ANAM measured the improvement. The ANAM post-treatment cognitive change scores accurately cross-correlated with CNS-Vital signs and other standardized instruments (e.g., PCS and depression scales, etc.) and examination by clinicians. Based upon IHMF's experience, the Congressionally-ordered ANAM pre-deployment baselines serve as an important national resource that will help reflect whether a given treatment is effective by accurately recording post-treatment cognitive changes.

The quality of life improvements resulting from HBOT intervention, including the ability of many to return to work, are documented in the study. Four of the study subjects for which there were ANAM baselines were service members being "medically boarded" out of the military following injury. All have been returned to duty following treatment. Examination of outcome data has shown HBOT is very cost effective. Biologically repairing brain injury is far less costly than the other consequences. Over time, the improved productivity and reduced medication costs more than justify HBOT treatment. Further, biological repair with HBOT helps make all other effective treatments for brain injury or PTSD even more effective and less costly.

Though TRICARE has been paying intermittently and the VA have paid occasionally, HBOT treatment for TBI or PTSD is not yet routine, even though Tricare, VA and Medicare pay for 13 other approved HBOT indications. Note that HBOT is already FDA-approved, and paid by these payers, for 3 kinds of neurological indications and 3 kinds of non-healing wounds. The same cannot be said for any of the FDA-Black labeled drugs routinely given to our veterans suffering from TBI or PTSD. The science is clear. There is, in fact, more evidence right now for HBOT 1.5 for treating brain injury or PTSD than there was for tPA for stroke treatment or angioplasty when they were both approved by Medicare and paid throughout the government system.