Prose To Go

If you're a veteran with low-risk prostate cancer, you can't get treated at the VA hospital in Philadelphia. That's because the program was suspended last year after Dr. Gary D. Kao botched radiation treatment at the hospital, operating with virtually no outside scrutiny. He blew 92 of 116 cancer treatments for over six years and kept it quiet, according to a New York Times investigation.

The surgeon spoiled a prostate cancer patient's radiation-seed implant by placing them in his bladder. Under federal rules, regulators checked into the error, but Kao merely rewrote his surgical plan to show he'd implanted 40 seeds in the prostate. The patient had to undergo a second procedure but Kao failed again, embedding seeds into the rectum. Kao again rewrote the surgical plan and regulators didn't complain.

No one knows for sure if the failures caused any deaths.

Every accredited hospital has peer review, or colleagues examining each other's work; this didn't happen at the Philly hospital. Three regulatory agencies, including the Joint Commission that accredits hospitals and the Nuclear Regulatory Commission, which regulates the use of all nuclear materials, did not intercede.

Veterans officials said that Kao no longer works at the Philadelphia hospital and would not return. They also admitted they had failed to supervise the unit.

"I’m not easily shaken,” said Dr. Leon S. Malmud, chairman of a nuclear commission advisory committee, in May. “But this is a very anxiety-provoking story."

If that unit were at a university, the feds would have suspended the program while conducting an investigation. In May 1999, the government temporarily shut down federally funded research on humans at Duke University Medical Center, one of the nation's largest and most prestigious medical research institutions, after investigators decided that Duke could not guarantee their safety.

The Duke federal license suspension to conduct human research was probably the largest ever in terms of the number of studies, people affected and the dollars at stake. Back then, Duke received about $175 million a year from the federal government for medical research.

Earlier in 1999, problems emerged at the Los Angeles VA Hospital, sparking concern that federal protections for human research subjects were inadequate or poorly enforced.

Each university performing research has an Institutional Review Board. The board reviews all proposed human research to ensure it's scientifically and ethically suitable and meets all federal regulations.

Investigators found that Duke's board wasn't keeping enough written documents, explaining how it decided to allow studies to continue.

Perhaps the feds have too many agencies overseeing this vital research. The government should devise a streamlined system, possibly based at the National Institutes of Health or the Centers for Disease Control, to regulate all research institutions. Otherwise, mistakes will continue and critically ill people can't benefit from the latest treatments.