The chief medical research and development officer for the Department of Veterans Affairs says some reports about research investigations at VA hospitals are incorrect, and she wants to set the record straight about events that prompted her to order a nationwide review of the department's research program.
Nelda Wray, M.D., says she first became aware of the ongoing investigations of patient deaths in studies at hospitals in Detroit and Albany, N.Y., when she was appointed director of research on Jan. 1.
On March 6, she issued an order requiring ethics training and good clinical practice training for all employees involved in clinical research. The courses must be completed by June 6 by all researchers, research coordinators and research assistants. Additionally, all researchers must be credentialed and reconfirmed annually.
"There was no stoppage of the human studies program," Wray says. "But we did do a component of the classic stand-down, which is to look closely at safety issues and make sure research is as safe as possible."
Some 10,000 researchers at the VA conduct about 15,000 clinical studies. The research involves approximately 150,000 patients at 115 sites.
Wray confirms that the VA has joined federal prosecutors in an investigation of two researchers in Albany concerning the fabrication of data that may have contributed to one or more patient deaths. She also says it is correct that an internal investigation in Detroit found an overdose of steroids contributed to a patient's death last April. The investigations were reported April 12 in the New York Times.
But Wray denies that there is any evidence confirming the report that one patient has died and 22 patients have suffered adverse drug reactions since last September as a result of research at the veterans' hospital in Fargo, N.D.
"Any patient with any adverse event must be reported to a review board that is independent of the study and will conduct an investigation to see if it is related to research," Wray says.
Each adverse event at Fargo has been reviewed and determined not to be due to the study, Wray says. "There were no research-related deaths there or at any other institutions that I am aware of."
The report that the department found "serious noncompliance" at VA hospitals in Pittsburgh, Providence, R.I., Martinez, Calif., and Long Beach Calif., is an "old story," Wray says. While an external review in the late 1990s by the National Committee for Quality Assurance and the VA's independent Office of Research and Compliance did find administrative problems, Wray says each site corrected those issues months ago.
"There is no evidence that those sites had any issue of patient safety or patient complaint," Wray says. "The Office of Research and Compliance has worked with each of those sites, and they have been approved for being in complete compliance."
Wray, who is on leave from Baylor College of Medicine in Dallas where she teaches medicine and medical ethics, says the VA must take a balanced approach to scientifically sound research and protecting patient safety.
"I have to assure that veteran patients and taxpayers have full confidence in the veterans research program," Wray says. "To assure the confidence in the program that it deserves I asked for a complete review."