Dr. Hoffer in Iraq in 2008 / Marine photo by G.P. Ingersoll
A U.S. military doctor deployed to Iraq subjected troops suffering from traumatic brain injuries to treatment with an unapproved drug, in which he had a financial stake, that may have harmed them, Pentagon investigators report. But a colleague of the doctor insists the probe is a perplexing witch hunt — and that the medication helps troops suffering from mild TBI, the signature wound of the wars in Afghanistan and Iraq.
The strange case of Dr. Michael Hoffer is detailed in a 136-page Pentagon inspector general’s report noted in the IG’s semi-annual report released Wednesday. Among its key findings:
— The management and conduct of the clinical trial were inconsistent with military standards for human subject medical research
— Possible sub-standard patient care
— Weaknesses in the process used to review and approve medical research in Iraq
— A potential financial conflict of interest was not disclosed.
— Documentation of funding [for the study] is unclear.
— Patients were exposed to possible coercion or undue influence.
— The experimental drug was not approved by the Food and Drug Administration for clinical study.
None of this, of course, is reassuring to the families of the men and women in harm’s way. But Hoffer’s case shows the pressure the military is under to help reduce TBI’s toll. TBIs are wounds suffered by troops when they are blasted with improvised explosive devices that bruise their brains inside their skulls. Symptoms of mild TBI include fatigue, headaches, memory loss, dizziness, depression, sleep disturbances, seizures and post-traumatic stress.
“When you have an individual with traumatic brain injury, 80 to 90 percent of the time you can be assured that that individual probably has post-traumatic stress,” the Army’s No. 2 officer, General Peter Chiarelli, told Battleland last month. And troops with PTS are six times more likely to kill themselves. There were nearly 140,000 diagnosed cases of mild TBI suffered by U.S. troops fighting in Afghanistan and Iraq through April 2010. On Thursday, the Army announced there were 21 potential suicides – up from 16 the month before.
Hoffer gave about half the 80 troops suffering from TBI an anti-oxidant tablet — on which he holds two patents for its use for other medical applications — from December 2008 to March 2009. The other half got a placebo for the week-long treatment. He did this while deployed to Camp Taqaddum 40 miles west of Baghdad. “The health and well being of these wounded Service members may have been jeopardized,” the Pentagon IG reported. It added that the Pentagon should investigate to ensure that no one was harmed by the medication, and that it probe “potential medical research misconduct” by Hoffer “and take appropriate action as required.”
The original complaint to the IG two years ago alleged “that a military physician was conducting sub-standard human subject research on deployed, injured U.S. Service members in Iraq,” the report said. “The research protocol proposed that early treatment with the antioxidant n-Acetylcysteine (NAC) could reduce the effects of mTBI after a concussion, specifically, dizziness and hearing loss. According to a U.S. Army official, this study was the first clinical drug trial conducted with U.S. Service members in a combat zone. Potential human subjects for this study were deployed U.S. Service members, recently exposed to a blast incident (e.g., improvised explosive devices) and evacuated to Camp TQ for evaluation and treatment.” Hoffer is not named in the redacted report, but his identity surfaced last month in a story in the North County Times near San Diego. NAC is commonly sold as an unregulated nutritional supplement.
While the FDA did not approve the study, six different Army medical groups did. Hoffer himself did nothing to hide it. He spoke of his mission for a Marine press release in late 2008:
“…we recognized the fact that although we’re set up to do ‘blood and guts’ surgery, (Taqaddum Surgical) can take on a secondary mission.” Taqaddum Surgical’s secondary mission: the Theater TBI Center of Excellence…Now if Marines experience a blast of any size, or a collision, crews medevac them to Camp Taqaddum for immediate treatment…Hoffer also introduced a new TBI rehabilitation treatment, which is in its test phase, but may also prove to be somewhat preventative. “When a brain cell dies, it releases oxygen free radicals and these free radicals attack nearby cells,” said Hoffer…“A cell has its own outside defense against invaders, but (in the case of TBI) it’s like a platoon sized defense against a brigade,” said Hoffer. “If we put in antioxidants, we increase that cell’s natural defenses.” At least that’s the theory. Hoffer is staging the first ever double-blind, placebo-controlled test performed in Iraq here at the center to gather evidence that antioxidants improve recovery from TBI symptoms. If proven effective, they could be issued to corpsmen to give to Marines immediately following an event, and therapy could start immediately, said Hoffer…Since the center has opened, 40 patients have received treatment. Thirty-five have returned to finish their deployments, 100 percent recovered.
Double-blind, placebo-controlled experiments require neither the researcher nor patients know if patients are getting the medical treatment or mere sugar pills, and that the assessment of the medication’s merit be done after the study is concluded, the IG said. Hoffer’s claim of 100% recovery “was misleading since the research was ongoing and the results were unavailable.” Making TBI patients visit Hoffer’s medical facility for treatment was tantamount to “coercion” designed to compel them to participate in his experiment. “The rights of the research participants were jeopardized,” it added.
Hoffer is now working as an ear, nose and throat specialist at the Navy’s San Diego medical center. “I’m not allowed to speak about it,” he said of the IG report Thursday. “It’s not that I have no comment — I’m just not available for comment.”
“Navy Medicine has conducted a thorough review of medical records of all personnel who participated in the study and thus far, the evidence suggests that no physical harm was caused by the administration of the investigational drug,” Captain Cappy Surette, a Navy medicine spokesman, says. Rules for such experiments, he adds, will be tightened by the end of the year. “It is important to separate [Hoffer’s] role as a physician from his role of a researcher,” Surette adds. “He continues his duties as a physician as his clinical practices treating patients have not been called into question.”
Dr. Carey Balaban, a neuro-scientist at the University of Pittsburgh who collaborated with Hoffer on the study from Pennsylvania, finds the entire episode befuddling. “I wish I understood what’s going on,” he said Thursday. The paper he and Hoffer wrote about their experiment — showing that the medication works — has been gathering dust at the Pentagon, he complained. “That manuscript has been sitting around since February 2010 — a year and a half ago,” Balaban says. “The data certainly indicate it helps.”
Not so fast, says the Navy. It maintains that the controversy surrounding Hoffer’s work has kept the report on ice. “The charges which are being investigated include description of research misconduct which, if true, could invalidate the integrity of the study and its findings,” Surette says. “Any data collected in execution of this study therefore cannot be released or relied upon unless those accusations are determined to not have impaired the data integrity. The investigation is continuing.”