A summary of the inspector general's investigation released late last week said that "management and conduct of the clinical trial were inconsistent with military standards for human subject medical research."
The report also said it's possible that patients involved in the study received substandard care, and it found problems with the review process used for military medical research conducted in Iraq.
At issue is an experimental treatment being used for those suffering from traumatic brain injury, an often hard-to-spot injury that can lead to permanent brain damage. Traumatic brain injury is often associated with people who have survived a roadside bomb attack or a car crash, and symptoms might not emerge for days.
Since the invasion of Iraq, traumatic brain injury associated with roadside bomb attacks has rapidly emerged as one of the leading health issues for U.S. troops.
The study, titled "The Use of Anti-Oxidants to Reduce Sequela of Mild Traumatic Brain Injury (mTBI) After Blast Exposure," was conducted at Camp Al Taqaddum, Iraq, during 2008 and 2009, according to a description of the clinical trial posted on a government website. The lead investigator was a U.S. Navy physician.
Those taking part in the trial were service members who had recently been in a bomb attack; they were given N-acetyl-cysteine, an anti-oxidant used in nutritional supplements and pharmaceutical drugs.
The Pentagon released only a summary of the investigation, which was prompted by a tip to the inspector general's hotline. It's unclear, based on the report, what happened to the patients involved in the study.
Capt. Cappy Surette, a spokesman for the U.S. Navy Bureau of Medicine and Surgery, declined to comment on the investigation, saying that "this is still an ongoing issue," and referred queries to the Defense Department's inspector general.
Gary Comerford, a spokesman for the Pentagon's inspector general, referred further questions about the study and its patients back to the Navy. "The only thing I can talk about is the results of our review," he said.