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.
