UCLA Researcher Gets Reprimand for Marrow Tests
The National Institutes of Health has formally reprimanded a prominent UCLA medical researcher for human bone marrow transplant experiments conducted without the approval of a faculty committee responsible for protecting the rights of patients, The Times has learned.
In a report released under the Freedom of Information Act, the agency held Dr. Robert P. Gale responsible for multiple violations of federal rules governing human experimentation in the treatment of terminally ill cancer patients at the UCLA Medical Center in 1978 and 1979.
Under conditions spelled out in a letter of reprimand signed by National Institutes director James B. Wyngaarden on Nov. 25, Gale will be allowed to continue working with human subjects but he must be closely monitored until March 1, 1988. In addition, UCLA must prepare an audit of research records for a randomly selected group of patients treated at UCLA Medical Center under the large federal grants for which Gale is responsible.
Funding Will Continue
Gale will be able to continue receiving federal research money and to serve on the National Institutes’ own scientific advisory committees. He is the principal investigator on a four-year, $3-million bone marrow transplant research project awarded to UCLA.
Gale continues to disagree with many of the findings by a team of National Institutes of Health officials, who began reviewing research conducted at UCLA’s bone marrow transplant unit in 1981, shortly after a story on allegations of rule violations appeared in The Times.
He complained in a detailed rebuttal to a 1984 draft report that the initial findings were riddled with errors and that the long delay in completing the review was by itself unfair. Gale has long contended that the bone marrow transplants called into question were not experiments at all, but simply the best treatment available for hopelessly ill patients.
However, in an interview Friday, he said he could not find fault with Wyngaarden’s action.
“It’s hard to make a cogent argument not to be more careful (in protecting patient rights),” he said, noting that the National Institutes has put his projects “under careful scrutiny for the last five years, and it has not produced any unexpected results.”
Charles R. McCarthy, director of the federal agency’s office for protection from research risks, described the actions taken against Gale as “a severe slap on the wrist.”
“It will at least give his colleagues pause,” McCarthy said.
Wyngaarden said in letters to Gale and UCLA officials that the response to the violations was restrained for several reasons. They included confusion over UCLA’s human experimentation policies in the late 1970s, the high degree of public attention Gale has already received and the lack of evidence that patients were injured as a result of the violations.
The panel of top federal scientific officials who reviewed the UCLA controversy for the National Institutes made it clear, however, that it regarded the violations as “serious failures to observe (federal and campus) policies.”
“Some members were concerned about Dr. Gale’s continued refusal to accept responsibility for multiple failures to comply with the regulations,” the panel’s report said.
Patient Consent Documents
McCarthy indicated that a simple repentant letter from Gale might have ended the matter without the need for formal sanctions. He said that the federal research agency would have settled the issue much more quickly if Gale had not challenged assertion after assertion in earlier draft reports.
Under federal rules, all human experimentation on the UCLA campus, whether funded by federal money or not, must be approved in advance by the school’s human subjects review committee. The committee must determine that the risks of any experiment are outweighed by the potential benefits.
Committee members also review patient consent documents to be sure that patients are fully informed about both risks and benefits of experimental treatment.
At issue in the Gale case was a series of bone marrow transplants given to terminal cancer patients at the UCLA Medical Center in 1978 and 1979.
In these procedures, the blood-producing cells of the patient’s own bone marrow are destroyed and replaced with marrow extracted from a close relative of the patient.
For certain diseases affecting the marrow, including some forms of leukemia and aplastic anemia, the transplants are now widely accepted as the best treatment available.
The treatment carries considerable risk, however, and when it is unsuccessful it can shorten a patient’s life.
Article Spurs Controversy
But in 1978 and 1979, Gale and other physician-scientists on the UCLA bone marrow transplant unit were using the technique on terminally ill cancer patients when transplants were not yet the acceptable choice of treatment.
In July, 1979, the unit’s nursing staff challenged the use of bone marrow transplants in several cases where the procedure was not standard treatment and there was no approval from UCLA’s human subjects protection committee.
The faculty committee concluded that Gale and his colleagues on the bone marrow transplant unit had violated the federal rules. And the panel imposed strict conditions on future human experimentation.
But when several UCLA researchers, including Gale, published the results of an experimental treatment for leukemia, the controversy boiled over. Dr. Sherman Mellinkoff, dean of the medical school, reprimanded six of the publication’s authors. Among the group were several of the most prestigious scientists at UCLA. Their actions, Mellinkoff argued at the time, threatened all federal funding for medical research on the Westwood campus.
But the school failed to notify the National Institutes of Health, as required under the federal rules.
The report released this week by the National Institutes noted that several improvements have been made to ensure that similar violations are unlikely to happen again.
The investigators found no fault with UCLA’s handling of the case. In a letter to the federal agency, UCLA Vice Chancellor Albert A. Barber said that the school was “comfortable with the findings.”
