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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.
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.
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 supervised or trained in what constitutes a substandard implant and the need to report it.
Virtually none of the substandard implants in Philadelphia were reported to the nuclear commission, 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. The officials acknowledged that they had failed to supervise the unit.
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.
The brachytherapy program at the Philadelphia V.A. hospital began in early 2002, giving veterans an option for treating prostate cancer without major surgery. In this procedure, metal seeds the size of a grain of rice are permanently inserted into the prostate through needles.
“The idea is to create a radioactive cloud that conforms to and treats the prostate,” said Dr. Louis Potters, department chairman of radiation medicine at North Shore Long Island Jewish Health System.
By using ultrasound in the operating room, Dr. Potters can assess how well radiation is being distributed. “So at the completion of the case,” he said, “I can go out and tell that patient’s wife or significant other that we did a very good implant.”
And good implants were what the Philadelphia V.A. expected when it staffed the new unit with outside contractors from an Ivy League institution, the University of Pennsylvania School of Medicine.
One contractor was Dr. Kao. In addition to his work as a cancer researcher, he had a medical degree from Johns Hopkins and a Ph.D. from Penn. He is also on a team from Penn that won a contract this year from a NASA-financed consortium to study radiation in space.
Although Dr. Kao was board certified in radiation oncology, he had limited experience in brachytherapy, according to the nuclear commission. Even so, the unit had no peer review.
“In every facility that I’ve ever practiced and seen, there is some form of peer review going on,” said Dr. James Welsh, a radiation oncologist and member of the nuclear commission’s advisory board.
It was not long before problems began to surface. In the first year, nine implants were substandard, including two on the same day, records show.
In early 2003, the V.A. and the nuclear commission got their first solid clue that all was not right in the cancer unit.
On Feb. 3, Dr. Kao mistakenly implanted more than half the seeds in a patient’s bladder. With the patient still under anesthesia, a urologist had to thread a small tube through the man’s penis to retrieve the 40 errant seeds. Because they were bloody and contaminated with urine, the seeds could not be reused, and no more were available.
As a carcinogen that can burn healthy tissue as well as kill cancerous cells, radiation is supposed to be closely monitored. The hospital’s radiation safety committee handles regulatory issues. The V.A.’s National Health Physics Program oversees radiation use in all veteran facilities.
But the chief regulator is the Nuclear Regulatory Commission. Serious accidents involving radioactive materials must be reported to that agency, which has the power to investigate and levy fines. Congress receives an annual list of those accidents.
After learning of Dr. Kao’s error, V.A. officials thought that because he had revised his surgical plan while still in the operating room, the mistake did not exist. The nuclear commission agreed, on the ground that doctors needed freedom to revise their surgical plan depending on what they found during surgery.
Yet this case did not involve a new diagnostic interpretation: it was an implant mistake, causing the patient to return for another procedure.
The Nuclear Regulatory Commission lacked the authority to challenge Dr. Kao’s revisions, said Steven A. Reynolds, director of nuclear materials safety for the commission. “The N.R.C. isn’t in the business of practicing medicine,” Mr. Reynolds said.
The substandard implants might never have been discovered were it not for a clerical error.
In the spring of 2008, a radiation safety official at the V.A. mistakenly ordered seeds of lower strength, and they were implanted.
After the error was discovered, according to the nuclear commission, the V.A.’s national radiation safety unit asked the hospital to examine 10 to 20 more cases to see if the problem had occurred before.
It had not. But investigators found something more troubling: four instances where seeds were implanted in the wrong places. As more cases were examined, more mistakes were found.
“Every once in a while you’re going to have a medical event because the seed will migrate, but when you see more than one or two at one place, we’re like: ‘What’s going on? Is this a pervasive problem?’ ” said Mr. Reynolds, the nuclear commission official.
The hospital suspended the brachytherapy program on June 11 last year. By then, 45 substandard implants had been found.
Two days later, the Joint Commission, which helps set standards in the hospital industry, surveyed the Philadelphia V.A. and on the next day accredited the hospital. “This organization is in full compliance with applicable standards,” the Joint Commission said.
The commission said that it had no indications of the problems in the brachytherapy program when it arrived at the hospital and that its surveys are not detailed enough to have uncovered the flawed implants.
Soon after, the N.R.C. sent its own inspectors to Philadelphia. And the more the inspectors looked, the more they found. All told, 57 of the implants delivered too little radiation to the prostate, either because the seeds missed the prostate or were not distributed properly inside the prostate. Thirty-five other cases involved overdoses to other parts of the body. An unspecified number of patients were both underdosed in the prostate and overdosed elsewhere.
From December 2006 to November 2007, the nuclear commission found, 16 patients received seed implants in Philadelphia even though computer interface problems prevented medical personnel from determining whether those treatments had been successful. The V.A.’s radiation officials knew of the problem but took no action, the nuclear commission charges.
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