By Nick Schwellenbach
Yesterday afternoon, the Department of Defense Office of Inspector General (DoD OIG) posted: “Results in Brief: Assessment of Allegations Concerning Traumatic Brain Injury Research Integrity in Iraq.” The results in brief confirm that a mild traumatic brain injury clinical trial (mTBI) in Iraq was “inconsistent with military standards for human subject medical research.” The two other findings by the OIG are that there was “possible sub-standard patient care” and “weaknesses in the process used to review and approve medical research in Iraq.” The assessment was completed on Thursday and the full “For Official Use Only” report is not publicly available, only the results in brief.
Despite the DoD OIG’s confirmation of misconduct, many questions remain, as evidenced by the DoD OIG’s numerous recommendations. The two recommendations that popped out at me were:
- The DoD’s chief acquisition official should “ensure that procedures are in place to adequately protect the rights of deployed personnel from coercion and undue influence to participate in research studies” and;
- The Assistant Secretary of Defense for Health Affairs should “conduct health assessments to determine if there were any adverse effects on the health of the U.S. Service members who participated in the mTBI clinical trial.”
Without the full report, it’s hard to know how deeply the DoD OIG delved into these and other areas. I’ve asked the DoD OIG spokesman whether the DoD OIG found any evidence—conclusive or not—that there may have been adverse effects. I’ll update this post if I get more information.
The clinical trial is "The Use of Anti-Oxidants to Reduce Sequela of Mild Traumatic Brain Injury (mTBI) After Blast Exposure," conducted at Camp Al Taqaddum, Iraq, between December 2008 and March 2009. The trial's principal investigator is Navy Captain Michael E. Hoffer, who is a medical doctor. According to the ClinicalTrials.gov website, the trial was completed on August 10, 2010—within a week and a half of when I first broke the story that the OIG was reviewing allegations of research misconduct and mentioned this clinical trial.
“The sequela of mTBI include balance disorders, hearing loss, and cognitive dysfunction,” according to a description of the clinical trial. “Evidence exists in laboratory work and in human studies that anti-oxidant medicine can reduce/eliminate the sequela of mTBI if administered within 8-24 hours of injury.” The trial proposed to compare “the effectiveness of the observation and administration of the anti-oxidant NAC [N-acetyl-cysteine] to placebo in individuals suffering the sequela of mTBI after a single or multiple blast exposures.”
Both the Boston Globe and I reported last year that approximately 80 servicemembers “were improperly used as subjects in a test of a possible treatment for brain injuries,” as the Globe put it. A source told me that many of these 80 were Marines.
As I wrote in my Center for Public Integrity article last July:
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.
Image: Divine Harvester