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At V.A. Hospital, a Rogue Cancer Unit - NY Times

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At V.A. Hospital, a Rogue Cancer Unit

http://graphics8.nytimes.com/images/2009/06/21/health/21radiation03-600.jpg
The Veterans Affairs Medical Center in Philadelphia.

For patients with prostate cancer, it is a common surgical procedure: a doctor
implants dozens of radioactive seeds to attack the disease. But when Dr. Gary
D. Kao treated one patient at the veterans’ hospital in Philadelphia, his aim was
more than a little off. Most of the seeds, 40 in all, landed in the patient’s healthy
bladder, not the prostate.

It was a serious mistake, and under federal rules, regulators investigated. But
Dr. Kao, with their consent, made his mistake all but disappear. He simply rewrote
his surgical plan to match the number of seeds in the prostate, investigators said.
The revision may have made Dr. Kao look better, but it did nothing for the patient,
who had to undergo a second implant. It failed, too, resulting in an unintended
dose to the rectum. Regulators knew nothing of this second mistake because
no one reported it.

Two years later, in 2005, Dr. Kao rewrote another surgical plan after putting half
the seeds in the wrong organ. Once again, regulators did not object. Had the
government responded more aggressively, it might have uncovered a rogue cancer
unit at the hospital, one that operated with virtually no outside scrutiny and
botched 92 of 116 cancer treatments over a span of more than six years — and
then kept quiet about it, according to interviews with investigators, government
officials and public records. The team continued implants for a year even though
the equipment that measured whether patients received the proper radiation dose
was broken. The radiation safety committee at the Veterans Affairs hospital knew
of this problem but took no action, records show.

One patient was the Rev. Ricardo Flippin, a 21-year veteran of the Air Force. “I
couldn’t walk and I couldn’t stand,” he said, citing rectal pain so severe that he had
to remain in bed for six months, losing his church job and his income. Pastor Flippin
first learned of what his doctors called a radiation injury not from the V.A., but from
an Ohio hospital where he underwent rectal surgery in 2006 to treat the damage.
“There are times when I don’t have control over my bowels,” he said one recent
Sunday, after excusing himself during a service at a church in West Virginia where
he now preaches.

The 92 implant errors resulted from a systemwide failure in which none of the
safeguards that were supposed to protect veterans from poor medical care worked,
an examination by The New York Times has found. Peer review, a staple of every good
hospital, in which colleagues examine one another’s work, did not exist in the unit. The
V.A.’s radiation safety program; the Nuclear Regulatory Commission, which regulates
the use of all nuclear materials; and the Joint Commission, a group that accredited the
hospital, all failed to intervene; either their inspections had been limited or they had not
acted decisively upon finding problems.

Over all, the implant program lacked a “safety culture,” the nuclear commission found.
Dr. Kao and other members of his team, the commission said, were not properly super-
vised or trained in what constitutes a substandard implant and the need to report it.
Dr. Kao declined to comment for this article.

Virtually none of the substandard implants in Philadelphia were reported to the nuclear
ommission, meaning errors went uninvestigated for weeks, months and sometimes years.
During that time, many patients did not know that their cancer treatments were flawed.
Federal investigators are continuing to look into the flawed implants as well as those at
other V.A. hospitals. The Philadelphia prostate unit was closed after problems began to
surface in mid-2008, and it has yet to reopen. The V.A. has also suspended the implants,
known as brachytherapy, at hospitals in Jackson, Miss., and Cincinnati, though neither had
problems on a scale of Philadelphia’s.

The V.A. has yet to fully account for how these substandard implants affected veterans,
though no one is believed to have died from them. No patient names have been made
public. Veterans officials said Dr. Kao was no longer at the Philadelphia hospital and would
not be allowed to return. The officials acknowledged that they had failed to supervise the
unit. A lawyer for Dr. Kao, Jack L. Gruenstein, said The Times’s account of the doctor’s role
was “false,” but he declined to elaborate.

A nuclear commission consultant, Dr. Ronald E. Goans, reviewed about a quarter of the
substandard implants and reported that “erratic seed placement caused a number of cases
to have elevated doses to the rectum, bladder or perineum.” After learning of the problems,
the V.A. flew seven patients treated in Philadelphia to its most experienced brachytherapy
program in Seattle for additional implants.

“I’m not easily shaken,” Dr. Leon S. Malmud, chairman of a nuclear commission advisory
committee, said last month after investigators briefed the panel on their findings in
Philadelphia. “But this is a very anxiety-provoking story.”

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