Almost as soon as the Philadelphia VA Medical Center began offering radiation seed therapy to prostate cancer patients in 2002, questions arose about the quality of the treatment, federal investigators said.
Yet it wasn't until a year ago that anything happened. The Philadelphia VA suspended the "brachytherapy" treatment program and began examining whether more than 100 veterans had received inadequate radiation doses.
The Nuclear Regulatory Commission, which oversees such radiation therapy, launched an investigation and published some results this month in the Federal Register.
In recent news reports, the extent of the problems with the brachytherapy program became public. Of 92 mismanaged cases, 57 men got significantly less radiation than prescribed, and 35 received excessive doses, including 25 who received too much radiation to the rectum.
NRC investigators found numerous systemwide problems at the Philadelphia VA, among them:
Brachytherapy clinicians had never been trained in how to define a medical error, or how to report such an event.
Independent review of case records, a standard quality assurance measure, was nonexistent.
Radiation safety monitors did quarterly audits, but did not detect problems.
This all came out not because the NRC finished its inquiry; regulators return to the Philadelphia VA this week, and their report is expected this fall. Rather, the revelations emerged because an NRC advisory committee asked the agency for an update at its regular public meeting.
Committee members had been hearing disturbing things about the Philadelphia VA's program.
"The rumor came out through the radiation therapy community," Temple University nuclear physician Leon Malmud, the advisory panel chair, said in an interview yesterday. "Normally, we would not be informed until the NRC completes its investigation."
By the end of the committee's May 7 meeting, a transcript shows, some of the 13 experts still couldn't fathom how recognized flaws went unreported, undocumented, and uncorrected - for six years.
"It is mindboggling to me," said adviser James M. Welsh, a radiation oncologist from Wisconsin, "that a physician could say that a dose . . . is acceptable, and then look at these implants and not realize that this is gross incompetence."
"Probably the thing that bothers me the most," said adviser Orhan Suleiman, who represents the Food and Drug Administration, is that "the consulting physicist had identified some problems earlier on. . . . If they had a concern, who did they report that to? Were they aware that they had that responsibility?"
Malmud, emeritus dean of the Temple University School of Medicine, closed the discussion with the fundamental question - one that still hasn't been answered: "How do we assure the public that this will not happen again?"
In brachytherapy, physicians permanently insert 80 to 120 radioactive metal "seeds," each the size of a rice grain.
If the seeds are properly implanted, the prostate tumor is killed with no serious damage to the bladder or rectum.
Brachytherapy is an option only for patients with small, early-stage, non-aggressive prostate cancers.
It is not yet known whether the prognosis for the 57 men who received inadequate radiation will be worsened by their under-treatment. However, eight patients received additional seed implants at the VA Medical Center in Seattle, a Philadelphia VA spokesman said.
To provide brachytherapy, the Philadelphia VA contracted with radiation oncologists, medical physicists, and dosimetrists (specialists in calculating radiation dosages) from the University of Pennsylvania.
The VA is a teaching hospital for Penn.
Nearly all the problematic brachytherapy implants were performed by a Penn radiation oncologist, Gary Kao, who stopped seeing patients a year ago and is now doing lab work at Penn, according to a Penn official.
Kao was not mentioned by name during the advisory committee meeting, but NRC physicist Darrel Wiedeman said "the physician that was primarily involved in the brachytherapy program consistently" placed a large number of the radioactive seeds "incorrectly."
In one case, the error may have contributed to rectal damage.
A medical physicist "realized back in 2002 that there was a problem" and confronted the radiation oncologist, Wiedeman said. No formal corrective action was taken.
"He [the oncologist] just said he would try to improve his technique," Wiedeman told the committee.
The NRC discovered the dosing errors almost by accident. Richard Whittington, a part-time physician at the VA and a Penn radiation oncologist, alerted regulators to an unrelated problem involving an order of radioactive seeds. Whittington declined to comment yesterday.
"That led the NRC to look," Malmud said yesterday, "and they found this" bigger challenge.