In 2009, and again in 2010, Paul Harch, MD, Director of the LSU Hyperbaric Medicine Department, delivered testimony to both the House and Senate Armed Services Committee reminding them that the epidemic of suicides amongst military veterans was most likely due to cocktail of “off—label” antidepressants they were being prescribed – Black-Boxed antidepressants. None of which are approved for treating TBI. Others have delivered this warning as well. The exact FDA warning states: “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.”
While antidepressants are modestly effective in reducing the symptoms of severe depression, they increase the brain’s susceptibility to future episodes after they have been discontinued. This fact contradicts pharmaceutical company sponsored research as antidepressants cause neuronal damage and mature neurons to revert to an immature state, both of which may explain why antidepressants also cause neurons to undergo apoptosis (programmed death) . If antidepressants cause death on a micro level then it is much easier to understand why certain patients commit suicide given the human body (macro level) is made up of these cells. So, not only are black-boxed off-label Selective Serotonin Reuptake Inhibitors (SSRI’s) prescribed to a vulnerable population but they are done so without any regard to an ability to metabolize this class of drugs  which further exacerbates suicidal behaviors. And then it seems SSRIs actually deplete both catecholamine and serotonin , which is exactly what isn’t in a depressed individual’s interest.
Up against black-boxed anti-depressants that are not efficacious, it should be a “no-brainer” to use a safe, off-label drug, i.e., oxygen at hyperbaric doses, to treat those who have received a TBI now with two decades of use treating various neurological conditions (the double-blind RCT by Rockswold , showing HBOT effective in treating acute severe TBI, was published in 1992 - decreasing mortality in the acute treatment on severe TBI 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). So, what is the problem? What does it take to become “standard-of-care?”
As already pointed out, HBOT is non-patentable. Research on non-patentable or off-patent drugs or with insufficient marketing prospects (orphan drugs) is funded by nonprofit or charitable organizations only. Drugs for which a patent cannot be granted are not being developed, and/or marketed even when they respond to a public health need. Patients, pharmacists, physicians and other caregivers consequently cannot take advantage of potentially effective treatments – they can’t even find out about them.
But while HBOT won’t make any entity large profits, doesn’t it have other monetary incentives? For each active duty brain injured solider returned to duty the lifetime savings to the government is $2.6 million dollars and $2 million for each injured service member returned to work or school. Between 60 and 80 percent of the veterans participating in the National Brain Injury Rescue and Rehabilitation (NBIRR) project are returning to work, duty or school after receiving HBOT. One would think that would move the powers-that-be to action, but it has not, and the reason for that may be because all they can see is what an injured veteran will cost should they stay alive. That is a serious accusation, so to better understand this controversial area on how the Department of Defense (DoD) handles TBI, the NFL provides an example of what takes place on a smaller scale.
For many decades, evidence has linked repetitive traumatic brain injury to long-term neurological problems in many sports. The NFL as the organizer, marketer, and face of the most popular sport in the United States, in which head trauma is a regular occurrence, was aware of the evidence and the risks associated with repetitive traumatic brain injuries and concussions for decades, but apparently ignored and worse actively concealed the information from those who participated in organized football at all levels. That is now the basis of hundreds of lawsuits.
So, what seems to have taken place is the NFL inserted itself into the scientific research and discussion concerning the relationship between concussions and short-term and long-term impairment of the brain. After doing so, the NFL then intentionally and fraudulently mislead present and former players, and all people who reasonably rely upon the NFL’s expertise about its own sport, regarding the short-term and long-term risks posed by concussions and head trauma.
Rather than warn players that they risked permanent brain injury if they returned to play too soon after sustaining a concussion, the NFL actively deceived players, by misrepresenting to them that concussions did not present serious, life-altering risks.
The NFL created the Mild Traumatic Brain Injury Committee (the “MTBI Committee”) in 1994 to research and ameliorates the impact of concussions on NFL players. Notwithstanding the purported purpose of the MTBI Committee, and despite clear medical evidence that on-field concussions led directly to brain injuries with tragic results for players at every level of the sport, the NFL failed to inform its current and former players of the true risks associated with such head trauma and purposefully misrepresented and/or concealed medical evidence on that issue. The NFL also stonewalled on an intervention and therapy that could be helping injured players regardless of whether those injuries were acute or chronic. The author has firsthand experience dealing with the NFL’s 88 Plan in an attempt to get veteran NFL players with dementia HBOT.
The 88 Plan is designed to assist players who are vested under the Bert Bell/Pete Rozelle NFL Player Retirement Plan and who are determined to have dementia. But if a plan member tries to get HBOT using the plan because they have been diagnosed with CTE, they will be told CTE does not cause dementia and therefore HBOT, which treats CTE, will not be a covered benefit. Obviously, that is irrational, but there is often madness behind the reason for not allowing an effective treatment to be utilized by those that need it. In the case of military veterans, for 20 suicides every day might be seen as a tremendous cost saving to certain decision makers. Yet it goes beyond money for if the military embraced HBOT as a viable therapy of TBI/PTSD then many, many troops who are on active duty with TBI/PTSD will come forward once they know there is an efficacious intervention that is recognized by the military. In so coming forward, troop strength could be decimated. This is the fear, and this is what has driven faux research funded by the Department of Defense.
All civilian studies published have been reported as positive even a randomized Israeli study, while all the Department of Defense studies have been consistently negative. One study had to go so far as to say that it was “biologically implausible” for compressed room air to have a healing effect on the brain. That would be called conformational bias if only this were about bias, but this was a deliberate and orchestrated attempt to scuttle HBOT as a recognized therapy for the above reason. Yes, it is illegal to waste tax payer dollars knowing you are creating pseudo-science, but that is beyond the scope to this editorial.
Now, this is truly misanthropic, but no more so than what tobacco corporations do and we still tolerate their malfeasance. In the case of the NFL, the reason for prevaricating about TBI and potential treatments is just a business decision. The exposure of the “hit squad” of the New Orleans’s Saints, where there was a bounty put on players from opposing teams, is a clear example of what kind of business this is about.
A great deal of time has been lost by those who believe hyperbaric oxygen is either a placebo, sham or should be subjected to placebo-controlled studies – or want others to believe this. But oxygen can never be a placebo. HBOT is an FDA-approved drug that affects non-specific biological repair; in fact it is the only non-hormonal FDA-approved treatment known to repair and regenerate human tissue. It does so at a DNA level by activating growth factors and reviving mitochondrial function . The beneficial effects of HBOT apply no matter where a wound or injury is located in the body.
Many peer-reviewed articles have been published in the last decade that demonstrates HBOT is effective at repairing an injured brain even long after that injury took place. One of the most notable was the article published by Harch et al.  using only one half of the NBIRR protocol (Forty 60 min treatments at 1.5 atmospheres). The blast-induced TBI war veterans experienced a 15 point IQ increase (p < 0.001), 39 % reduction in post concussion symptoms, 30 % reduction in PTSD symptoms and a 51 % decrease in depression. This is all consistent with past-published reports of HBOT in chronic brain injury, including research by the US Army on brain-injured children .
The first battle casualty to be treated with HBOT (1.5), and one of the few to be treated was General Patt Maney (retired) for his blast-induced brain injury in Afghanistan. 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 back to Afghanistan. After HBOT treatment he was discharged from Walter Reed and returned to his civilian job as a Florida state judge.
He received treatment from George Washington University Medical Center at the Tricare Reimbursement rate of $250 per treatment. Counting lost time and hospital costs, his months at Walter Reed making no progress; the DoD spent $400,950, with a permanent disability loss to the service of $1.3 million. Had he received HBOT (at 1.5 atmospheres) 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 the 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 $12,000 less than what a RAND report states the annual ongoing costs per year of the current treatments for mild-TBI is,Footnote 2 and that is a lot of SSRI’s.
Since every working person represents $1 million in tax revenue over their working life to the government, that government should be interested in, and foster payment for, biological repair of brain injury. Thus every brain injured veteran, all 700,000+ of them, at a cost of $60,000 per year to the economy every year in increased costs and lost productivity, is a $42 billion drain on the economy. Treated, they immediately set about doing what young people do, they begin to form families and create the next American generation. Injured, they are unable to do so, and it is highly likely that these untreated brain injuries are a major cause of our nation’s economic challenges. But bureaucracies do not think logically – their ability to think laterally is limited. When Medicare approved HBOT to treat diabetic foot ulcers at the end of 2002, they only made it available for Wagner III and IV lesions (osteomyelitis and gangrene) so afraid they were of budgetary constraints.
HBOT prevents 75 % of major limb amputations in Wagner III and IV ulcers, but if they had included Wagner II lesions HBOT would be preventing 88 % of amputations. So, the result is there are a lot of unnecessary amputations not because of bad science, but because technocrats were afraid of having a short term budget problem.