Veterans’ Hospitals to Boost Training

Veterans' hospitals to boost training - Federal memorandum calls for administrators to be more aware of human research programs

By BRENDAN LYONS, Staff writer

First published: Saturday, April 26, 2003

Top administrators at Veterans Affairs hospitals across the nation will undergo specialized training on human research programs as a result, in part, of alleged violations that occurred in cancer studies at Stratton VA Medical Center, according to a federal memorandum.

The development of an intensive training course was ordered April 15 by Anthony J. Principi, secretary of the Department of Veterans Affairs, who outlined his concerns in an internal memorandum to Dr. Robert H. Roswell, the VA's undersecretary for health.

"As you know, I am extremely concerned about the violations of research protocol that have recently occurred," Principi wrote in the memorandum, a copy of which was obtained by the Times Union. "Additional action must be taken immediately to strengthen oversight of these programs."

Veterans Affairs officials in Washington, D.C., were not available for comment Friday.

"This comes way too late for Mr. Steubing and the other patients who were harmed at the VA," said Alan Milstein, a Philadelphia attorney representing the family of Carl Steubing -- a former Stratton VA cancer study patient who died last year.

Steubing's family has filed a federal lawsuit against two former cancer specialists at Stratton who no longer work at the VA but are at the center of an ongoing criminal investigation. Federal authorities said they are examining at least five patient deaths at Stratton, including Steubing's.

Principi ordered that the mandatory training program for hospital directors, associate chiefs of staff of research and other top VA hospital officials be created within 90 days. It will include training on informed consent by patients enrolled in research programs, legal issues and compliance regulations, according to the memo.

The directive comes on the heels of the Bush administration ordering a review of medical research at more than 110 veterans' hospitals. In addition to an ongoing criminal investigation of patient deaths at Stratton VA, federal investigators are examining the deaths of patients in research programs at VA hospitals in Detroit and Fargo, N.D.

The sweeping reforms, including the proposed creation of an independent oversight office to keep tabs on medical research programs, are intended to prevent veterans from being used as guinea pigs in the VA's estimated $1 billion-a-year medical research studies, officials said.

The changes come as federal agents are conducting a criminal investigation of two former medical researchers at the Stratton VA -- Dr. James Holland and his chief research assistant, Paul Kornak.

Investigators are trying to determine whether Holland and Kornak falsified medical records to enroll patients in experimental drug trials. In December, Holland and Kornak were both suspended by the hospital.

Other changes being considered include tightening controls on how drug companies notify hospitals of any potential problems in research programs and a requirement that the study programs undergo periodic inspections.

In the Albany case, federal authorities are examining whether patients may have died as a result of having their medical backgrounds forged in order to be enrolled in study programs.

Ilex Oncology, a Texas company that sponsored one of Stratton VA's cancer studies, discovered problems in the program in December 2001 and notified a hospital official about its findings. Despite the warning, cancer patients in the program continued to receive controversial treatments for at least 10 months, according to an official familiar with the case.

VA officials said it took too long for hospital officials at Stratton VA to learn about the alleged discrepancies discovered by Ilex two years ago and even longer for them to do anything about it.

Finally, last fall, the Stratton VA's cancer research program underwent an intensive review by the Food and Drug Administration, which uncovered serious problems that are now the focus of the criminal investigation. Relatives of former cancer patients are questioning whether family members may have died prematurely or suffered intense discomfort because hospital officials were too slow to call for an investigation of the allegations.