PHILADELPHIA, PA—Investigators from the Nuclear Regulatory Commission and Congress are looking into possible botched procedures conducted through a brachytherapy program to treat prostate cancer at the Philadelphia VA Medical Center. Over the course of 6 years, nearly 100 patients may have received doses of radiation to areas that were not on the prostate and underdosing of radiation to their cancer.

Brachytherapy for prostate cancer is a form of nuclear radiotherapy where small radioactive seeds are implanted in the prostate to destroy cancerous cells. The Philadelphia VAMC has offered the procedure since 2002. In May 2008, a radiation oncologist at the facility performed a permanent implant prostate brachytherapy procedure using seeds of a lower activity than intended. A physicist discovered this under-dosage 10 days after the initial procedure. The physicist notified the facility’s Radiation Safety Officer, who immediately reported the problem to VA’s National Health Physics Program. The Nuclear Regulatory Commission was notified shortly after.

An investigation by independent physicians showed that such underdosing had occurred in many previous procedures, with radioactive seeds becoming lodged in areas outside the prostate. In none of the previous cases—92 out of 114 procedures performed, according to investigators— were the problems ever reported to any authority outside the Philadelphia VAMC or to the NRC. The program was shut down in June pending further investigation.

Effective Treatment or Botched Procedure?

That oncologist, Gary Kao, MD, PhD, has become the target of media reports and for government investigators. Doctor Kao performed the majority of the 92 procedures and headed up the brachytherapy program at the medical center. Doctor Kao testified at the field hearing that nothing untoward ever occurred in any of the procedures, that the misplacement of seeds was a recognized and accepted danger, and that he and his team were unaware of any responsibility they had to report such incidents. “I, along with others at the Philadelphia VA, implemented the brachytherapy program to serve the best interests of veterans,” Dr Kao said. “There were precise operating standards implemented and followed. As with any program it is not without incidents or challenges.”

That NRC required such incidents to be reported was never part of his training, Dr Kao said, nor was it clarified by NRC personnel during previous investigations at the hospital. He also testified that NRC standards for a reportable medical event do not take into account a number of factors that might mitigate the errors.

“The appropriate standard for brachytherapy should not be determined by the NRC definition of a reportable medical event,” Dr Kao stated. “There are a number of other factors that should determine appropriateness of treatment, including number of seeds, location of seeds in the prostate, location seeds outside the prostate, the concentration of seeds in the effective area of the prostate, the size, and shape of the prostate, the size, grade, and extent of the cancer, and the clinical follow-up of the PSA test results. All of these variables are not addressed in the NRC defined standards.”

During questioning, Dr Kao admitted that he had implanted seeds in areas outside the prostate, including the bladder and other nearby organs. He also admitted that when that occurred, he did not inform the patient. When asked why not, Dr Kao said, “Even when seeds are outside the prostate, they still contribute a radiation dose to their cancer.” “At the time that the program was implemented [in 2002], the definition of what is [a reportable medical event] to the NRC was not in existence. If we had been aware of this definition, we would have acted to notify the NRC and the patient,” he said. “In retrospect I should have known the definition of what is reportable has changed throughout the years.”

He added, “I do not believe our procedures were botched. I do recognize there were occasions when we could have done better. I still maintain we rendered effective treatment.”

Regulatory Breakdown

According to VA and NRC officials, the 92 implant errors went undetected for 6 years because none of the regulatory procedures that should have been in place were actually followed. This began with Dr Kao’s and his team’s ignorance of NRC regulations. According to NRC guidelines, when any of the radioactive seeds used in the procedure become lodged in an area where they were not meant to, the NRC needed to be notified. “We expect this. In fact, the VA’s license requires them to identify problems like this and report it to us,” explained Steven Reynolds, NRC director, division of nuclear materials safety for the region.

Physicians performing the procedure should have informed the facility’s radiation safety officer in charge of oversight for all radioactive materials at the VAMC about any aberrations in the procedure, Reynolds said.

Doctor Gerald Cross, VA’s principal deputy secretary for health, noted that even external reviews—including one performed by the American College of Radiation Oncology—also did not detect any problems with the program at Philadelphia, and even rated it above average. “Many of these systems failed to detect the aberrant care at Philadelphia, and, in fact, it was only the recognition of potential problems by VA staff that eventually led to more in-depth investigation, review, and subsequent disclosure to patients and the public,” Dr. Cross said.

As for how it went undetected for 6 years, Dr Cross pointed at the extremely close relationship between the VAMC and the University of Pennsylvania. “There is something unique in this situation at Philadelphia that we would not find at other facilities, and that’s in the nature of the contract and the nature of the relationship with the university. In my review of this program, it’s almost indistinguishable where the university ends and the VA begins,” Dr. Cross declared. “That arrangement, I think, was part of the problem. We value relationships with our university affiliates. But in this case, there was a contract. And the contract had some, in my experience, unusual language. To the point, when the reviewers reviewed the program from the American College of Radiation Oncology, they made the following statement—‘This radiation oncology department is under the control of the University of Pennsylvania.’”

Doctor Cross admitted that despite this relationship, it was VA’s responsibility to provide oversight of procedures performed on veterans. According to Dr Cross, VA has hired a highly regarded oncologist to review the program at Philadelphia, and is bringing all individuals involved in the program to VA’s Central Office for additional training and review of procedures and policies.

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