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PHILLY VA INVESTIGATING ITS PROSTATE CANCER
TREATMENTS -- In the last six years, 114
prostate-
cancer patients might have received radiation
doses below what was prescribed.
For more about veterans and prostate cancer, use
the VA Watchdog search engine...click here...
http://www.yourvabenefits.org/sessearch.
php?q=prostate+cancer&op=ph
Story here...
http://www.philly.com/philly/hp/
news_update/20080812_VA_hospital_inves
tigating_its_treatments.html
Story below:
-------------------------
VA hospital
investigating its treatments
It said 114 cancer
patients might have received the wrong radiation doses. Another case
involves blood samples.
By Tom Avril and Josh Goldstein
Inquirer Staff Writers
In the last six years,
114 prostate-cancer patients at the Philadelphia VA Medical Center might
have received radiation doses below what was prescribed, the hospital
said.
The men underwent brachytherapy, in which radioactive rods or seeds were
implanted in and around the prostate to destroy cancer cells. Most
patients who receive the seeds alone have low-risk prostate cancer,
experts said.
"The program was suspended as soon as the problem was discovered,"
hospital spokeswoman Fern S. Billet said. "We are in the midst of an
investigation to find out what happened."
 Two
patients have since died, but it was unclear whether their deaths were
related to the problem, she said. The other men had diagnostic tests
performed at the VA's expense, and doctors were evaluating those scans.
VA officials also are investigating an incident in which an Air Force
veteran on the blood thinner warfarin had his blood drawn twice July 30
and was put in a research study without his knowledge or consent.
Marc Holmes, 66, of Queen Village, was one of as many as six patients
whose blood was drawn without their consent, the hospital said.
"What precipitated them selecting us?" asked Holmes, who has suffered from
blood clots. "Was there something wrong with us medically? Are they under
any obligation to tell us? I would imagine they would be."
Billet, the spokeswoman, confirmed that the hospital had no authorization
to draw the second vial of blood from Holmes and said an investigation
board was formed to review the matter. The research has been put on hold,
she said.
Asked whether the VA seemed to be having a number of quality issues
lately, Dale Warman, another medical-center spokesman, stressed that "the
brachytherapy and warfarin dosage issues are unrelated, and it is a
coincidence that they were discovered within a short period of time."
He said caregivers were taking steps to fix both problems. Like most
hospitals, the medical center received full accreditation from the Joint
Commission, the main U.S. accrediting body, after an unannounced visit in
June.
An outside expert said he was suprised to hear about the problem with low
radiation doses for prostate-cancer patients, which was first announced
July 2. "The routine in the U.S. is to assess the implant at three to four
weeks out," said Eric M. Horwitz, clinical director of the radiation
oncology department at Fox Chase Cancer Center.
"The worst-case scenario is that their prostate cancer wasn't adequately
treated, and it never went away or it came back," Horwitz said.
Leonard G. Gomella, urology chairman at Jefferson Kimmel Cancer Center,
said, "Fortunately, many of these men probably had low-risk prostate
cancer, so hopefully they will be OK."
Holmes, the Air Force veteran who did not consent to participate in the
study of blood-thinning medication, said he was not satisfied with the
hospital's explanation for the July 30 incident.
He said that he initially received conflicting information at the hospital
when he asked whether he was enrolled in a study, and that one doctor
became hostile when Holmes questioned him.
He said that after he expressed his concerns, a physician gave him the
second vial of blood in a padded envelope.
In response to a reporter's inquiry, the hospital said the study was
titled "Warfarin Dosing - Comparison of a Pharmacogenetic Algorithmic
Approach With the Current Empirical Approach" - apparently an analysis of
how physicians determine dosing.
The hospital institutional review board (IRB), which oversees all
research, approved the nonfunded study as "a noninvasive, retrospective
review of records" - which, except for the blood being drawn, would not
require patient consent, the VA maintained.
Strict rules govern the conduct of studies that get federal funding. This
one did not, but an ethical line may have been crossed, said Jon Merz,
associate professor of bioethics at the University of Pennsylvania.
"If they didn't get IRB approval, and they didn't get consent from people,
and they're taking the blood for research, then it's wrong on lots of
levels," Merz said.
Sanctions would depend on whether the incident was simply an oversight,
Merz said.
As for that vial of blood, Holmes said he was stunned when it was
presented to him.
"What the hell am I going to do with it?" he asked. "Give me a needle, let
me put this back in my arm?"
For now, it's in his refrigerator.
Contact staff writer Josh Goldstein at 215-854-4733 or
jgoldstein@phillynews.com.
-------------------------
posted by Larry
Scott
Founder and Editor
VA Watchdog dot Org
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