Pentagon says military medical research trial was badly done

By Jennifer Rizzo, CNN National Security Producer

STORY HIGHLIGHTS

• Inspector General report points to "possible substandard patient care"
• Trial researched effect of supplement on troops with mild brain injury
• Full report not yet released

(CNN) -- A military medical research trial looking into an experimental treatment for traumatic brain injury was improperly conducted, the Pentagon's Inspector General recently stated.

The military's IG review found the "management and conduct of the trial were inconsistent with military standards for human subject medical research." The report stated concerns of "possible substandard patient care" as well as flaws in the review and approval process of the research.

The trial researched the effect of the over-the-counter antioxidant supplement, N-acetyl-cysteine, on the hearing and balance functions of troops diagnosed with a mild traumatic brain injury after being exposed to a blast, according to the Bureau of Navy Medicine. The bureau is responsible for all Navy and Marine Corps medical functions.

About 80 service members, 57 of them Marines, participated in the trial, which was conducted between December 2008 and March 2009 by a Navy doctor at Camp Al Taqaddum in Iraq. The Army was responsible for oversight of the medical research, according to Inspector General spokesman Gary Comerford.

The Defense Department's investigating arm received a hotline complaint about the study by a senior military medical officer in May 2009, Comerford said, and started probing in June 2009.

Details of the findings have not yet been released to the public, but recommendations have been made to the Navy and Army, including ensuring procedures are in place to protect troops from being coerced into participating in research studies.

The U.S. Army Surgeon General is currently conducting an investigation into the management and conduct of the clinical trial, according to Comerford. He would not comment further on whether there was evidence of coercion.

"Many of the policy and regulatory conditions that allowed this to occur have already been addressed and corrected, or are in the process of being addressed and corrected," he said.

The review also recommended health assessments be done to determine if any participating service members suffered "adverse effects."

The Bureau of Navy Medicine is in the process of conducting health assessments for identified Navy and Marine Corps service members involved in the study, a Navy official told CNN. The assistant secretary of defense for health affairs at the Pentagon is overseeing this process, according to Comerford. No comment could be given by either on whether side effects were identified.

The IG office is currently working on a redacted copy cleared for public viewing. The Navy would not comment further until the redacted copy is released.

"We look forward to the full disclosure of the IG report," said David Autry, spokesman for Disabled American Veterans. "I can see the potential for needing to do a long-term assessment of the study participants to see if there were any adverse effects."

Source: http://rss.cnn.com/~r/rss/cnn_health/~3/PGJEoV154l4/index.html

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