"Medical research misconduct" on brain injured soldiers

Eighty soldiers suffering from mild traumatic brain injury in Iraq participated in a clinical trial in 2008-2009 that was found to have "medical research misconduct" according to an investigation by the Department of Defense's Inspector General obtained by CBS News.

Soldiers who participated in the study had been exposed to blasts within 24 hours and were flown to Camp Al Taqaddum, Iraq. Half of the soldiers were treated with a placebo while the other half were given an anti-oxidant called N-acetylcysteine or NAC.

While there is no standard treatment for mild traumatic brain injury, investigators found the study did not use standard military concussion assessments on the soldiers possibly resulting in "sub-standard care".

In addition to the NAC, soldiers were also given seizure and migraine medications to treat headaches that "should be avoided in the treatment of post-concussive symptoms" according to the report which indicates that "clinical practice guidelines for the treatment of [mild traumatic brain injury] in theater" dictates that only Tylenol should be used.

The Navy's Bureau of Medicine and Surgery told CBS News that they have reviewed medical records of the soldiers involved and found no evidence of "physical harm" so far. However, the Navy says they are now reaching out to the soldiers involved to conduct follow-up interviews.

The physician who ran the trial, Dr. Michael E. Hoffer, was also found to have two financial conflicts of interest since he is listed as an inventor on two U.S. patents which are associated with the use of NAC. Dr. Hoffer did not respond to repeated requests for comment from CBS News.

The investigation also raises concerns that the soldiers were coerced to participate since they were brought from the site of their injuries directly to Camp Al Taqaddum where the Marines were asked to participate. Reviewers who examined the study said they feared the "military member's sense of honor, duty and loyalty" may have obliged them to enroll.

Funding for the trial is unclear. The Navy says "there may have been multiple funding sources," and indicated it hopes to provide an answer in the future.

The Brooke Army Medical Center that is listed as the sponsor of the trial told CBS News they could not comment because of an ongoing investigation into the trial by the U.S. Army Surgeon General.

According to the Army, this was the first clinical trial on soldiers in a combat zone.

  • Laura Strickler

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