“…if the studies produce results that do not support OPH’s (Office of Public Health, Department of Veterans Affairs) unwritten policy, they do not release them…On rare occasions when embarrassing study results are released, data are manipulated to make them unintelligible…Anything that supports the position that the Gulf War illness is a neurological condition is unlikely to ever be published.”

These accusations are not your general run of the mill statements about flaws in a study. Nor are they minor violations of informed consent or breaches in protecting confidentiality. Instead they are accusations of serious failures in the responsible and ethical conduct of research, possibly including deaths, made by Steven Coughlin, former senior epidemiologist for the Office of Public Health at the Department of Veterans Affairs, in testimony before the Veterans Affairs Committee of the US Congress on March 13, 2013. According to our sources, fellow researchers at the VA think Coughlin has been “very courageous” in making his stand on these issues.

Second Epidemiologist

Also testifying with Coughlin was Baylor University epidemiologist Lea Steele who has worked on Gulf War Illness for many years and served as Scientific Director for the Research Advisory Committee on Gulf War Illnesses. In her testimony, Steele said, “…in some sectors within VA, there appears to have been backward movement, with actions that seem intended to ignore the science and minimize the fact that there is a serious medical condition resulting from military service in the 1991 Gulf War.” She also stated that “Together, VA’s poor representation of the Gulf War illness problem, and failure to apply current scientific knowledge to develop a focused, state-of-the-art research program, have led to relatively little in the way of tangible benefits for ill Gulf War veterans. From my perspective as a scientist who has worked in this area for many years, it is time to get this right…”

Case Definition

Gulf War Illness is the term commonly used for the symptomatic condition that affects military personnel who served in the 1990-91 Gulf War. At least one in four of the 700,000 military personnel who served in the war are affected, according to the Department of Veterans Affairs.

VA Testimony

At the same session, Dr Victoria Davey, Chief Officer, in the Office of Public Health and Environmental Hazards at the VA did not address in her testimony the statements made by Coughlin and Steele. However, she told the Committee “We remain committed to providing evidence-based, compassionate care for these Veterans, and for all of the Veterans it is our privilege to serve. VA intends to continue our ongoing efforts to improve our abilities to provide health care for Gulf War Veterans; to better educate our health care providers; and to expand the evidence basis for the treatments we provide Gulf War Veterans, and all Veterans.”

Ethical Failures

In an email to epidemiology colleagues following his testimony, Coughlin wrote about another concern of his, namely the responsibility of VA researchers to provide access to care for medical problems they encounter in the course of doing their research. Coughlin has tangled with the VA on that score as well.

According to Coughlin, “the VA currently has ongoing large scale epidemiologic studies that involve hundreds of thousands of US service men and women and US Veterans; the safeguards for ensuring that vulnerable men and women who are experiencing pronounced psychiatric distress receive appropriate follow-up care by a trained mental health professional varies widely across these studies. 

For example, in the National Health Study for a New Generation of US Veterans, which reached out to more than 60,000 US Veterans (20% women), only about 5% of nearly 2,000 men and women who self-reported suicide ideation ever received a call back from a study clinician.  Some of those research participants are now homeless and deceased.  The Cooperative Studies Protocol CSP Biorepository and Gulf War Survey initiative is currently reaching out to 100,000 Veterans who served in the first Gulf War.   

Although the majority of US Veterans are not "vulnerable," it is clear that many do have profound life challenges due to neurologic illness or injury, and other medical and psychiatric conditions. 

As a former Principal Investigator and co-investigator on large-scale, national epidemiologic surveys involving tens of thousands of US Veterans, I can tell you that 9 to 10% self-report that they are having thoughts that they would be better off dead, and that much more needs to be done to help these men and women who fought in a war, came home, and are now unemployed, sick, at-risk of homelessness, and in many cases "falling through the cracks."

Call for Consideration

Coughlin told colleagues that the Gulf War Veterans advocates who attended the Congressional panel stated that they feel that the epidemiology profession should examine these important issues and look inwardly about what happened and how to improve the situation in the future.  I agree with that viewpoint which is why I am writing to you with this summary information, so that you can share it with potentially interested colleagues.”

Steele told the Monitor that the scientific research and results produced by Coughlin’s former  office at the VA corroborate some of his  individual allegatons, specifically in relation to Gulf War illness research.  For example, a current national survey targeting 30,000 Gulf War veterans dos not include a symptoms inventory that would permit the study of Gulf War Illnes in a survey involving 30,000 veterans. A committee which had reviewed the study protocol had been very critical of the study and had advised the VA to include such an inventory. It was not done.

In interviews with media, Coughlin was even more outspoken about the deficiencies he says he witnessed. For example, in an interview with the Daily Beast, Coughlin said his bosses intimidated him every time he spoke about any alleged unethical activity.  When he went over their heads, “that’s when all hell broke loose,” he told the Daily Beast. “My supervisors tried to remove me from the study, and I received a written admonition. It was shocking. All I was trying to do was help ensure the safety of veterans participating in our study.”

The VA is reportedly investigating and says that all allegations of malfeasance are taken seriously and investigated fully.  

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