Gulf War Study Challenged on "Deficiencies"

A controversial U.S. research project on Gulf War illness got word yesterday that the government plans to end its support because of managers’ “persistent noncompliance and numerous performance deficiencies.” The Department of Veterans Affairs (VA) announced a decision to opt out of the study in a press release yesterday.

The study’s principal investigator is epidemiologist Robert Haley at the University of Texas Southwestern Medical Center at Dallas. Haley declined comment, referring questions to the UT Southwestern press office. Yesterday UT officials released a statement saying that they “were surprised to learn” of the government’s action. The brief statement says that UT officials “regret the VA’s unilateral decision not to renew the contract,” adding that “we strongly disagree with the VA’s characterization of the facts.”

Haley and UT Southwestern were the beneficiaries of an unusual federal contract that fulfills an earmark in a law passed by Congress in 2005, providing “not less than $15 million” for Gulf War illness studies. It envisioned a 5-year, $75 million project but allowed the government to reconsider the contract each year. VA was about to enter the 3rd year. According to an audit by the VA inspector general, about $8 million had been spent at UT by the end of January 2009. This summer, after the inspector general delivered a negative report, VA decided to redirect the remaining funds away from UT Southwestern to studies of fibromialgia and chronic fatigue syndrome among Gulf War vets.

Haley has been investigating evidence that military personnel during the first Gulf War in 1991 who were exposed to toxins, natural hazards, or medications designed to block nerve agents suffered neural problems as a result. Most researchers who have looked into this have not found a connection, but Haley has. In addition, Haley is developing diagnostic tools to identify veterans affected by such exposures.

A 15 July VA inspector general’s report found serious problems in the management of the UT Southwestern research but did not challenge the research itself. Among other allegations, the report charges that researchers failed to consult with an ethics review board on the design of a consent form signed by patients and did not agree that data from study volunteers would be properly shared. VA has proposed that UT researchers be paid to complete “work in progress” provided they submit “adequate documentation” and correct any deficiencies.