Dr. Steven S. Coughlin
Chairman Miller, and Members of the Subcommittee, thank you for the privilege of testifying today. I am Dr. Steven Coughlin, and I have worked as an epidemiologist for over twenty-five years, including positions as a senior cancer epidemiologist at the CDC and as Associate Professor of Epidemiology and Director of the Program in Public Health Ethics at Tulane University. I chaired the writing group that prepared the ethics guidelines for the American College of Epidemiology.
For the past 4 ½ years, I was a senior epidemiologist in the Office of Public Health at the Department of Veterans Affairs. In December 2012, I resigned my position in the US Civil Service because of serious ethical concerns that I am here to testify about today.
The Office of Public Health conducts large studies of the health of American veterans. However, if the studies produce results that do not support OPH’s unwritten policy, they do not release them. This applies to data regarding adverse health consequences of environmental exposures, such as burn pits in Iraq and Afghanistan, and toxic exposures in the Gulf War. On the rare occasions when embarrasing study results are released, data are manipulated to make them unintelligible.
The 2009-2010 National Health Study of a New Generation of US Veterans targeted 60,000 OIF and OEF veterans and cost $10 million plus the salaries of those of us who worked on it. Twenty to thirty percent of these veterans were also Gulf War veterans, and the study produced data regarding their exposures to pesticides, oil well fires, and pyridostigmine bromide pills. It also included meticulously coded data as to what medications they take. The Office of Public Health has not released these data, or even the fact that this important information on Gulf War veterans exists. Anything that supports the position that Gulf War illness is a neurological condition is unlikely to ever be published.
I coauthored a paper for publication on important research findings from the New Generation study on the relationship between exposures to burn pits and other inhalational hazards and asthma and bronchitis in OIF/OEF veterans. My supervisor, Dr. Aaron Schneiderman, told me not to look at data regarding hospitalizations and doctors’ visits. The tabulated findings obscure rather than highlight important associations. When I advised him I did not want to continue as a co-investigator under these circumstances, he threatened me. Speaking as a senior epidemiologist with almost 30 years of research experience, there is no reason to work night and day for years on a complex data collection effort (which cost US taxpayers millions of dollars) if you are not comfortable putting your name on publications stemming from the study or if no scientific publications are released.
Another example of important data that has never been released are the results of the Gulf War family registry mandated by Congress. These were physical examinations provided at no charge to Gulf War veterans’ family members. I have been advised that these results have been permanently lost.
The Office of Public Health has also manipulated information regarding veterans’ health through the questions included in their surveys. During the preparation of a major survey of Gulf War era veterans of which I was principal investigator, the Follow-up Study of a National Cohort of Gulf War and Gulf War Era Veterans, the Research Advisory Committee on Gulf War Illness made extensive recommendations regarding changes to the survey. I considered these changes as constructive, and some were adopted.
The VA Chief of Staff (COS) directed my supervisors to send the Gulf War study scientific protocol and draft questionnaire out for additional, objective scientific peer review. The OPH Chief Science Officer, Dr. Michael Peterson, contacted a long-time friend of his who is Dean of a school of public health, who identified a faculty member at his school, although the individual had no background in Gulf War health research. My direct supervisor, Dr. Schneiderman, spoke with the peer reviewer and told him that the RAC’s comments were politically motivated, i.e. not objective in nature. The reviewer responded that he would “certainly try to help out.” Not surprisingly, the reviewer's comments were very favorable. The Chief of Staff was never informed that the outside reviewer worked for a friend of Dr. Peterson.
My supervisors also made false statements in writing to the Chief of Staff. For example, they falsely stated that putting the study on hold long enough to revise the questionnaire would cost the Government $1,000,000, delay the study for a year or longer, and potentially result in contract default. None of this was true. But as a result, the Chief of Staff ordered the survey to proceed without the changes.
The Office of Public Health also handles VA’s dealings with the Institute of Medicine, which is part of the National Academies of Science. Congress and VA leadership rely on the Institute of Medicine for authoritative, objective information on medical science.
Last year, VA contracted with the IOM for a Congressionally-mandated study of treatments for chronic multisymptom illness in Gulf War veterans. Many Gulf War veterans were distressed that five speakers selected to brief the IOM committee presented the view that the illness may be psychiatric, although science long ago discredited that position. My understanding is that Dr. Peterson, an OPH Chief Science Officer, identified the speakers the IOM should invite.
I wish to close with a subject of particular importance to me. Almost 2,000 research participants from the New Generation survey self-reported that they had thoughts in the previous two weeks that they would be better off dead. However, only a small percentage of those veterans ever received a call back from a mental health clinician. Some of those veterans are now homeless or deceased. I was unsuccessful in getting senior Office of Public Health officials to address this problem in the New Generation study.
I was successful in incorporating these call-backs in the Gulf War survey, and they have saved lives, but only after my supervisors threatened to remove me from the study and attempted disciplinary action against me when I appealed their refusal to provide for call backs to higher authority.
I urge this Committee to direct VA to immediately identify procedures to ensure that veterans who participate in VA large-scale epidemiologic studies received appropriate follow-up care so that this tragedy is not repeated.
I also urge you to initiate legislation to cure the epidemic of serious ethical problems in the Office of Public Health I have described to you today. In view of the pervasive pattern where these officials fail to tell the truth, even to VA leadership, VA cannot be expected to reform itself. These problems impact the balance of risks and benefits of federally funded human subjects research costing tens of millions of dollars and which fail to serve the interests of the veterans they are intended to benefit.
Included below is additional written testimony regarding efforts to ensure that call-back services were available to Gulf War veterans expressing suicidal thoughts, and mechanisms to provide for the sharing of survey data to qualified researchers.
In the Spring of 2012, in the course of planning the follow study of Gulf War Veterans, I had discussions with my supervisors at VA and with the Chair of the Institutional Review Board (IRB) at the VA Medical Center in Washington, DC about the need to identify mental health professionals who could call-back research participants who were experiencing suicidal ideation and assist them with getting into VA health care. After my efforts to ensure that Veterans enrolled in the study were appropriately cared for were blocked by my supervisors, I contacted the IRB Chair and the VA Office of Inspector General. I was then openly threatened and retaliated against by my supervisors, who made false and misleading statements in writing about my efforts to put the call-back procedures in place. I received a written admonition and was also told I might be replaced as Principal Investigator of the study. Over the course of a few months, I successfully appealed the admonition by telling the truth, with the assistance of a VHA Deputy Under-Secretary.
In August of 2012, I was finally allowed to engage VAMC mental health professionals as co investigators on the study. Between August 2, 2012, and January 1, 2013, a team of licensed clinical social workers and psychologists completed 1,331 calls to Veterans. As of January 31st VHA clinical personnel have been able to directly contact 984 of those Veterans. Of these, 48 Veterans were referred to the Veterans Crisis Line for immediate assistance. The majority of calls provided the Veteran with either the Veterans Crisis Line toll free number, information about local resources including Vet Centers (local VA mental health centers) or community based outpatient clinics, and information on how to enroll for VA health care. Veterans were also encouraged to talk with their primary care physician about depression if they were not already engaged in mental health treatment. The VA mental health professionals who made the call-backs saved lives and ameliorated human suffering, partly by helping vulnerable research participants get access to health care benefits to which they are entitled to. When you are suffering from a neurologic condition such as Gulf War Illness, or a psychiatric condition such as major depression, it can be quite difficult to navigate the procedures for gaining access to health care benefits.
As a further practical suggestion, the Office of Public Health should put data from their surveys into VINCI (the VA Office of Research and Development’s national data sharing resource). There are a lot of qualified VA researchers around the country who would love to have access to New Gen Study data (e.g., the extensive coded data on prescription medications and doctors visits in the past year) that have never been published. VINCI provides requires IRB review and approval and strict confidentiality safeguards. OPH has lost some key data sets that were stored at the Austin automation center mainframe computer in Texas. A notable example is the national registry developed several years for family members of Gulf War Veterans. That registry database, which was mandated by Congress, is apparently lost forever. The use of the VINCI data repository and data sharing resource developed by the VA Office of Research and Development (ORD) would protect against future catastrophic loss of data.