Healthy Skepticism Library item: 1050

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Publication type: news

Pear R.
US to Review Research at Hospitals for Veterans Nationwide
The New York Times 2003 Apr 13
http://www.nytimes.com/2003/04/13/national/13VETS.html

Full text:

WASHINGTON, April 12 – The Bush administration has ordered a nationwide
review of medical research at 115 veterans’ hospitals and has halted some
studies after investigators found serious violations of federal rules,
including some that may have contributed to the deaths of patients.
The Department of Veterans Affairs said it was investigating the deaths of
patients in research projects at hospitals in Detroit, Albany and Fargo, N.D.
The department also said it had found “serious noncompliance” with federal
rules at its hospitals in Pittsburgh; Providence, R.I.; Martinez, Calif.; and
Long Beach, Calif, and detected problems at hospitals in Northampton, Mass.,
and Portland, Ore.
The new director of the veterans research program, Dr. Nelda P. Wray, ordered
the review last month after learning of cases in which researchers falsified
data and did not tell patients about the risks of experimental treatments.
“Those practices will not be tolerated,” Dr. Wray said.
Research is one of the principal missions of the Department of Veterans
Affairs, which spends nearly $1 billion a year on about 15,000 studies
involving 150,000 patients. Ethics committees are supposed to monitor each
study to protect patients.
An internal investigation by the department found that a huge overdose of a
prescription drug “led to the death of a research participant in a clinical
trial” at the veterans’ hospital in Detroit last year.
The department has joined federal prosecutors in a criminal investigation
of two researchers who worked at the veterans’ hospital in Albany.
Fabrication of data in those studies may have “contributed to the death of
one or more patients,” a memorandum from the department says
At the veterans’ hospital in North Dakota, all clinical research was halted
on Feb. 28. Federal experts who inspected the hospital said one patient had
died and 22 had suffered adverse reactions to drugs in research projects
since September. The adverse reactions were not promptly reviewed by the
hospital, according to the veterans agency’s office of research compliance
and assurance, a watchdog body.
An official report on the Fargo hospital says that a doctor there was listed,
“without his knowledge or consent,” as being responsible for patients in a
clinical trial comparing drugs for high blood pressure. In a letter
suspending research there, Dr. Jonathan B. Perlin, deputy under secretary of
veterans affairs, said the study, involving 87 patients, was not properly
supervised.
Some hospital administrators said they did not have enough money or employees
to comply with all the federal requirements.
Doctors at veterans’ hospitals have done pioneering research on spinal cord
injuries and schizophrenia, helped develop the implantable cardiac pacemaker
and the nicotine patch, and performed some of the first successful liver
transplants. The agency has also been a leader in analyzing medical errors.
But officials at those hospital now say they are reluctant to discuss
possible improprieties because they fear being sued. Jayne M. Steubing, the
widow of the Albany patient, Carl Steubing, sued last month, asserting that
researchers had falsified test results and improperly enrolled him in the
trial of a cancer drug, hastening his death from stomach cancer.
“Our whole purpose is to ensure that this kind of thing does not happen to
other people,” Mrs. Steubing said in an interview.
Investigators said the Detroit patient, Cyril V. Krcmarik, died after a
series of medical errors.
The Department of Veterans Affairs and the Food and Drug Administration
faulted researchers who treated Mr. Krcmarik for prostate cancer. He received
a large overdose of dexamethasone, a steroid to combat side effects of
chemotherapy.
Mr. Krcmarik lived near Saginaw, Mich., so he was allowed to fill his
prescription at the veterans’ hospital there. But, investigators said in a
recent report, the prescription was “incorrectly rewritten” by a doctor at
the Saginaw hospital and the pharmacist further changed the instructions, and
as a result the patient used a nine-month supply of the drug in less than
three weeks. Moreover, the report said, the government twice refilled Mr.
Krcmarik’s prescription and thus “missed opportunities” to correct his
dosing schedule before he died on April 2, 2002.
Mr. Krcmarik’s daughter-in-law, Claudia S. Krcmarik, said in an interview:
“The veterans’ hospital appeared to be a research machine, using these
elderly patients without enough oversight. This is a vulnerable age group.
You have people who are hard of hearing, may have difficulty understanding
instructions and tend to trust their doctors.”
Ann Talbot, a spokeswoman for the Detroit hospital, said: “Somebody died.
That was awful, and we are very seriously concerned.”
The researcher directing the study, Dr. Joseph A. Fontana, said: “The patient
was given more drug than he was supposed to get. That was a pharmacy error.
It will never happen again. I am doing things differently now.”
Federal officials told researchers at the V.A. Northern California Health
Care System, in Martinez, that they could not recruit or enroll any new
patients because they had not adequately protected veterans in clinical
research.
Inspectors from the Department of Veterans Affairs said the California
researchers did not properly assess the safety of experimental treatments,
overstated the benefits and did not adequately explain the risks to patients,
many with Alzheimer’s disease and other brain disorders.
Dr. Kenneth W. Kizer, who was under secretary of veterans affairs from 1994
to 1999, said: “The problems at the V.A. are not unique. Some prestigious
universities have similar problems. Clinicians view a lot of the federal
requirements as administrative hassles and do not take them seriously.”
But the chief of the agency’s research compliance office, Dr. John H.
Mather, said: “The rules are important. They reflect the ethical
underpinnings for the conduct of research, the need to treat other human
beings with dignity and respect.”
The agency’s Dr. Wray said all employees engaged in clinical research would
have to take courses in research ethics and “good clinical practice.” In
addition, she said, all researchers must have their credentials verified once
a year.
Federal officials said such verification procedures might have detected
problems with one of the Albany researchers, whose medical license was
revoked by Iowa and Pennsylvania in the early 1990’s.
Members of Congress recently introduced bipartisan legislation to strengthen
the research compliance office after learning that the Bush administration
was considering a proposal to reduce its autonomy.