pureheart

Research at US Veterans Hospitals Nationwide Under Investigation_NYT

Sun, 13 Apr 2003

Veterans returning from service in the military deserve better than
the medical care that awaits them at the nation's Veterans Affairs
(VA) medical centers. The Associated Press reported on Friday, April
11, that a study shows that patients suffering heart attacks who are
treated at VA hospitals have a significant greater chance of dying
than those treated at civilian hospitals under Medicare. [See:
http://www.wmcstations.com/Global/story.asp?S=1228527 ]

Adding insult to injury, despite poor patient care, the VA plays a
major role in the medical research enterprise. The VA spends nearly $1
billion a year on about 15,000 studies involving 150,000 patients.

Mounting evidence demonstrates that the patients who are subjected to
those medical experiments are ill served because the VA has done an
abysmal job of monitoring their safety. Indeed, the relative of one
such victimized veteran in Detroit characterized the VA hospitals as
"a research machine, using these elderly patients without enough
oversight."

Indeed, a recent scandal at the Albany VA, which is under a criminal
investigation, provided a window into substandard medical practices at
VA medical centers. The investigation uncovered evidence of lack of
oversight, fraud, and preventable deaths.

Following years of effort by a few veterans and a few whistle blowing
staff within VA facilities, the Department of VA was forced to
undertake a major internal investigation of deaths and "serious
noncompliance" with federal safety regulations. According to The New
York Times, the following are among the VA hospitals being
investigated: Detroit, Albany and Fargo, N.D., Pittsburgh; Providence,
R.I.; Martinez, Calif.; Long Beach, Calif, Northampton, Mass., and
Portland, Ore.

However, it is not clear who is charged with conducting the
investigation as the VA attempted to disband the independent Office of
Research Compliance and Assurance (ORCA) that had been established
after the last scandal in
1999. However, as AHRP reported on Thursday, a bill, HR 1585, was
introduced in Congress to prevent the VA from taking that action.
[See: http://www.ahrp.org/infomail/0403/10.html

[For details about Albany VA scandal See:
http://www.ahrp.org/infomail/0203/20.html ]

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
THE NEW YORK TIMES April 13, 2003

U.S. to Review Research at Hospitals for Veterans Nationwide By ROBERT
PEAR

http://www.nytimes.com/2003/04/13/national/13VETS.html

WASHINGTON, April 12 ó 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 ****yzing 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


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.

Copyright 2003 The New York Times Company

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scarlett6

<< Research at US Veterans Hospitals Nationwide Under Investigation_NYT

Sun, 13 Apr 2003

Veterans returning from service in the military deserve better than
the medical care that awaits them at the nation's Veterans Affairs
(VA) medical centers. The Associated Press reported on Friday, April
11, that a study shows that patients suffering heart attacks who are
treated at VA hospitals have a significant greater chance of dying
than those treated at civilian hospitals under Medicare. [See:
http://www.wmcstations.com/Global/story.asp?S=1228527 ]

Adding insult to injury, despite poor patient care, the VA plays a
major role in the medical research enterprise. The VA spends nearly $1
billion a year on about 15,000 studies involving 150,000 patients.

Mounting evidence demonstrates that the patients who are subjected to
those medical experiments are ill served because the VA has done an
abysmal job of monitoring their safety. Indeed, the relative of one
such victimized veteran in Detroit characterized the VA hospitals as
"a research machine, using these elderly patients without enough
oversight."

Indeed, a recent scandal at the Albany VA, which is under a criminal
investigation, provided a window into substandard medical practices at
VA medical centers. The investigation uncovered evidence of lack of
oversight, fraud, and preventable deaths.

Following years of effort by a few veterans and a few whistle blowing
staff within VA facilities, the Department of VA was forced to
undertake a major internal investigation of deaths and "serious
noncompliance" with federal safety regulations. According to The New
York Times, the following are among the VA hospitals being
investigated: Detroit, Albany and Fargo, N.D., Pittsburgh; Providence,
R.I.; Martinez, Calif.; Long Beach, Calif, Northampton, Mass., and
Portland, Ore.

However, it is not clear who is charged with conducting the
investigation as the VA attempted to disband the independent Office of
Research Compliance and Assurance (ORCA) that had been established
after the last scandal in
1999. However, as AHRP reported on Thursday, a bill, HR 1585, was
introduced in Congress to prevent the VA from taking that action.
[See: http://www.ahrp.org/infomail/0403/10.html

[For details about Albany VA scandal See:
http://www.ahrp.org/infomail/0203/20.html ]

Well, it is about time someone looked into the VA hospitals, I guess better
late than never.

One of my veteran friends had a foot amputated at our local VA hospital. He
emphatically insisted the doctor release him the next morning, much to the
doctor's surprise...Why? Because he could not get anyone to bring him any pain
medication, and he said at least at home, his wife would help him. This? After
an amputation? Some reward for people who serve our country...

Cathie

Cathie

coleah

: Well, it is about time someone looked into the VA
hospitals, I guess better
: late than never.
:
: One of my veteran friends had a foot amputated at our
local VA hospital. He
: emphatically insisted the doctor release him the next
morning, much to the
: doctor's surprise...Why? Because he could not get anyone
to bring him any pain
: medication, and he said at least at home, his wife would
help him. This? After
: an amputation? Some reward for people who serve our
country...
:
: Cathie
================
Sorry to hear your friend wasn't getting the timely
response he needed.

I've usually experienced good care once I'm settled in a
room.
Just once in the ER I had to wait three hours to be
evaluated before I could get pain medication. They were
extremely short handed and had a patient who kept coding
and was surrounded by all available staff working on him.
Yep, for three hours they kept restarting his heart until
he finally stabilized.

In the meantime I was crawling down the hall to the
bathroom and retching every 15 minutes with an inflamed
gall bladder full of stones. It took 3 shots of morphine
to kill the pain once they were able to get to me, then off
to surgery an hour later. It's hard to be patient when
you're the patient. I remember at one point wondering to
myself why they were working so hard on the old fart and
didn't just let him die. Then I realized I was I was
having a terrible pity party because I was hurting so bad
and that the old fart was someone's loved one too. Didn't
help the pain, but I bit harder on the bullet.....

Coleah

myrlj

I continue my stance that our veterans deserve the very best medical
care we can provide them. . .I believe that overall, their care is
substandard to what the average American has available to them in the
private sector. Therein, exists a crime. A grateful nation needs to
do far more!

Myrl