Alleged traumatic brain injury research misconduct investigated by Pentagon

Introduction

The Pentagon’s Office of Inspector General (OIG) is reviewing allegations of research misconduct in a mild traumatic brain injury clinical trial with U.S. Marines in Iraq, according to documents and interviews.

“DoD OIG will determine whether DoD guidance regarding the performance of research on human subjects was violated, and whether research misconduct occurred in a DoD approved clinical research trial evaluating the treatment of mild traumatic brain injury” in Iraq, according to a Pentagon OIG document. The document details planned and on-going audits, and says the review was initiated in June 2009.

A summary of the same review listed in a report by the Special Inspector General for Iraq Reconstruction adds that the Pentagon’s OIG is reviewing “if clinical research using an unapproved medication was conducted on U.S. service members with Traumatic Brain Injury in Iraq.”

Mild traumatic brain injury has affected at least 137,000 members of the armed services who have served in Iraq and Afghanistan, and some estimates put the number much higher. The often-devastating malady can cause vertigo, migraines, loss of balance, hearing loss, and other problems affecting memory and mental focus. Mild traumatic brain injury, or mTBI, is often caused by the blast wave associated with improvised explosive devices detonating near U.S. military vehicles.

A Pentagon source told the Center that the suspected research misconduct involves the use of a dietary supplement – N-acetylcysteine – a readily available, over the counter antioxidant. The source requested anonymity because he was not authorized to speak on the record about the review. There were “some questions about how it was being administered” during the clinical trial that took place December 2008 through December 2009, said the source.

The supplement is “generally not regulated by the FDA – but if it’s used to treat a medical condition, it comes under FDA oversight and must be approved for medical use” in a clinical trial, according to the source. FDA refers to the U.S. government’s Food and Drug Administration, which oversees the use of drugs in clinical trials.

N-acetylcysteine is used to treat a variety of ailments from helping to decongest lungs to counteracting carbon monoxide poisoning. Most mild traumatic brain injury victims suffer from a loss of hearing and balance – anti-oxidants like N-acetylcysteine might counteract these effects if service members are promptly treated after blast exposure, some medical experts believe.

An estimated 80 service members, mostly Marines, were treated with the supplement, the source said. So far, there is no indication of harmful side effects due to the use of the supplement, the source added.

The OIG review was initiated after a senior military medical officer contacted the DoD inspector general hotline.

A Navy spokesman referred the Center to the Pentagon’s OIG. The OIG spokesman said he could only confirm that his office was conducting a review.

One clinical trial appears to match up with some of the details listed in the Pentagon and Special Inspector General for Iraq Reconstruction documents and from the Pentagon source. Dr. Michael E. Hoffer of the Naval Medical Center in San Diego conducted a clinical trial in Iraq last year that examined “the use of one anti-oxidant, N acetylcysteine (NAC), in individuals who suffer blast injury and demonstrate early” aftereffects of mild traumatic brain injury, according to the study’s description.

“Evidence exists in laboratory work and in human studies that anti-oxidant medicine can reduce/eliminate the sequela [aftereffects] of mTBI if administered within 8-24 hours of injury,” according to the description.

Hoffer was based out of Al Taqaddum, Iraq.

Hoffer did not respond to e-mail and telephone messages.