'Hutch' imposes research rules

The Fred Hutchinson Cancer Research Center has adopted tough new rules to restrict researchers from having financial conflicts of interests in medical experiments.

The new standards, adopted a week ago by the center's Board of Trustees, ban researchers from owning stock or other equity in a company for which they are doing research.

The rules also require researchers to disclose consulting fees or other financial ties to companies both to patients and in journal articles about their research.

"The Hutch" has allocated $1 million a year to carry out its new rules.

The Rev. William Sullivan, former president of Seattle University and a Hutch trustee, said the center fully met the tough recommendations of an advisory committee he chaired last year, especially in banning financial conflicts for researchers.

"That's a very strong position and is unlike, as far as I know, that of any other research center in the country," he said.

Sullivan's advisory panel was created in March 2001, two weeks after The Seattle Times published a series of articles titled "Uninformed Consent: What patients at 'The Hutch' weren't told about the experiments in which they died." The Times reported that more than 20 people had died prematurely in two failed clinical trials in which Hutch researchers and the center itself had financial interests, and that doctors had failed to fully inform the patients of risks and alternatives.

Since Sullivan's committee made its recommendations in September, a new Patient Protection Oversight Committee has worked on coming up with new rules.

The rules still allow the center itself to own stock in companies for which it does research. Some medical-research centers, including Boston's Dana-Farber and Beth Israel Deaconess, don't allow such associations.

"Avoiding conflicts of interest, or even the appearance of conflicts of interest, on the part of individuals involved in human subject trials is of great importance to the center," according to a report issued this week by the Hutch committee. "At the same time, strong collaborations among for-profit life sciences companies, the non-profit and public sectors and individual scientists in the development of new technology are vital to the Center's goal of advancing scientific knowledge to save lives."

What to do about the center's financial conflicts will continue to be discussed, said Carl Behnke, vice chairman of the committee. He said The Hutch relies on money from businesses because it has a much smaller endowment that many other major centers.

The Hutch also still allows researchers to be paid by companies to be consultants and to serve on advisory boards as long as the payments don't exceed $10,000 a year. The Hutch worried that cutting off this income would hurt the center's recruiting efforts, Behnke said.

Asked if the committee checked to see how many researchers would be forced to sell stock because of the new rules, Behnke said, "We didn't, because we didn't care. We think this is the right thing to do."

The faculty at The Hutch supported the rule changes, Sullivan said. They take effect in July and researchers will have a year to divest themselves.

It's not clear whether the new rules would have addressed issues raised in The Times' series. In one clinical trial, Protocol 126, that ran from 1981 to 1993, three researchers who were given founders' shares in Genetic Systems studied a new use for monoclonal antibodies for which the company owned licensing rights. At least 20 patients died from causes attributable to that experiment, and questions about financial conflicts of interest were raised within The Hutch at the time.

Center officials have maintained that the researchers couldn't have profited from their research, so there wasn't a conflict of interest. However, nationally known biotech-patent attorneys say the researchers could have profited.

Either way, their original stock holdings eventually were worth millions of dollars.

Dr. John Pesando, a former Hutch researcher who alerted Times reporters to the problems in Protocol 126, said he's skeptical that the new rules will change anything.

He noted that The Hutch had an even stronger conflict-of-interest rule in 1983 but didn't enforce it.

He doesn't see an enforcement mechanism for the new rules.

The new rules say that if someone is caught intentionally violating them, they can be suspended or dismissed.

Bruce Pym, who chaired the patient-protection committee, said in a press release that The Hutch "has always fully complied with government regulations."

Sullivan's committee made the same claim last year.

However, the federal Food and Drug Administration suspended three clinical trials at the center in June after finding researchers were not complying with regulations, including those on informed consent.

An official warning letter — a rare and serious admonishment — was sent to a Hutch scientist Dec. 31. Members of Sullivan's committee had not been told of these actions.

Dr. Patricia Keegan, FDA deputy director for clinical trials in the Center for Biologics Evaluation, said then the FDA review showed "systemic problems with the way they approach clinical trials" at the Hutchinson Center and that a response blaming documentation was minimizing serious issues.

Also, the federal Office for Human Research Protections opened an investigation of The Hutch last year. Director Dr. Greg Koski said that case is still open.

In addition to the new conflict-of-interest policy, The Hutch's board created a new office to track ongoing regulations, hired a staff person to make sure informed-consent statements are easy to read and understand, hired a trainer to teach federal regulations, created a new research-ethics committee and contracted with independent reviewers to do a follow-up review.