Oncologist Faces Ethics Questions Over Release of Files
A Westside oncologist, already under scrutiny from the National Cancer Institute for discrepancies in data he submitted to a major national breast cancer study, is now the target of criticism for an alleged breach of medical ethics--releasing confidential patient files to a Chicago newspaper reporter.
A top NCI official said Monday that Dr. David Plotkin released the records without the permission of his patients. The agency has notified the federal Office for Protection From Research Risks--which monitors scientific research and has disciplinary powers--and an internal review board at Brotman Medical Center in Culver City, where Plotkin practices.
“A patient’s medical record is confidential and I think it’s very important that any of us, when we go to a physician, know that information about our health is not made public,” said Dr. Bruce Chabner, director of the division of cancer treatment at the NCI. “I think this was not ethical.”
A spokesman for Plotkin said the doctor had released the files on the condition that the reporter would not make the names of patients public--and he did not. “He sought and received a guarantee that no patient confidentiality would be breached,” said spokesman Larry Weinberg.
Nonetheless, experts in medical ethics say Plotkin acted improperly.
“You should not do it,” said Art Caplan, director of the Center for Bioethics at the University of Pennsylvania. “It is a given that a researcher’s obligation first and foremost is to protect patient privacy. Information should not be revealed, ever, without explicit subject consent or court order.”
The latest development involving Plotkin comes amid a wide-ranging probe into data discrepancies--and, in one case, outright fraud--in research conducted by the nation’s oldest and largest breast cancer study group, the National Surgical Adjuvant Breast and Bowel Project. The project is responsible for some of the most important breast cancer research in the country, including a landmark 1985 study that found that lumpectomy--in which only the cancerous tumor is removed--is as effective as mastectomy, in which the entire breast is removed.
But the group has been tarnished in recent months by revelations that a Canadian researcher, Dr. Roger Poisson, had falsified data so that women who were ineligible for the lumpectomy study could be included. The NCI says the fraud did not change the study’s outcome.
The disclosures prompted the NCI to force the head of the project, noted breast cancer researcher Bernard Fisher of the University of Pittsburgh, to resign. They have also spurred audits of participating institutions in New York and Louisiana, as well as the Memorial Cancer Research Foundation of Southern California, a one-doctor center run by Plotkin.
The NCI has found no evidence that Plotkin committed fraud, although it has found deficiencies in his files, including one case in which a woman who died after open-heart surgery was reported as being alive. Results of the NCI review are likely to be made public later this week, Chabner said. Meanwhile, the chief executive officer of Brotman Medical Center, a private 495-bed hospital with which Plotkin is affiliated, said the hospital is taking control of Plotkin’s files at the NCI’s request.
Plotkin contacted the NCI last week to request the review. He told officials that a reporter for the Chicago Tribune, John Crewdson, had presented him with an internal audit conducted by the NSABP in 1990 that showed serious discrepancies in his data. He said he had not known of the 1990 audit but allowed Crewdson to look at his files because he believed he had nothing to hide.
Weinberg, Plotkin’s spokesman, said the doctor feared that his reputation would be damaged if he did not permit Crewdson to examine his work. “He was scared,” Weinberg said. “It was an error.”
Crewdson, meanwhile, was also criticized by the NCI’s Chabner for examining the records. However, Dick Ciccone, managing editor of the Chicago Tribune, said that because the records consisted solely of NSABP enrollment data--as opposed to patient histories and disease prognoses--the paper does not believe there was a breach of confidentiality. But he acknowledged that the files included patient names as well as specific information, such as a patient’s tumor size, that help doctors determine whether women are eligible to participate in NSABP studies.
“This was not, in the classic sense, a violation,” Ciccone said.
What, if any, action might be taken against Plotkin for the alleged breach is unclear. The Office for Protection From Research Risks has the power to discipline researchers by barring them from receiving federal funding. But Plotkin has not participated in the NSABP since 1988.
In an interview with The Times shortly after Fisher was forced to step down, Plotkin defended Fisher, saying it was impossible for the head of the NSABP to know what each researcher had done.
At the same time, Plotkin said he had “markedly decreased” his own involvement in the NSABP because he did not like the direction the project was taking. In particular, he objected to a current--and highly controversial--clinical trial in which the NSABP is testing to see whether the drug tamoxifen can be used to prevent breast cancer.
He said he felt tamoxifen would not be effective and complained that the trial was initiated “because of pressure from feminist groups to do more studies on women.” And he said that, in participating in earlier NSABP research, including the lumpectomy study, he felt that he became “a tool of the feminists of Los Angeles in bringing about less radical surgery for breast cancer.”
Through his spokesman, Plotkin has declined interviews about the NCI audit.
