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UCSF studies plan to shift drug trials




 

Some fear loss of safeguards, funds if private entity takes over

The dean of UC-San Francisco's School of Medicine is considering a proposal some fear could skim money from lucrative drug trials and send it to an arm of the private UCSF-Stanford Health Care organization.

Administrators say the plan to handle contracts and other aspects of industry-sponsored research through the newly formed organization is very preliminary, and subject to faculty review and debate.

Even if the proposal is adopted, the research itself and the dollars it generates would continue to flow to the public medical school, they say.

An internal UCSF committee has recommended those and other changes in an effort to better compete in the rapidly expanding industry-sponsored research field. Private universities like Duke and Columbia have taken aggressive measures to lure companies to test their products on their campuses.

But at least one labor union and some faculty are worried that money over and above what's needed to pay for the studies could end up going to the private entity, jointly owned by the Stanford and UCSF medical schools. Called overhead, the money is about 30 percent of the total contract. It is supposed to cover day-to-day costs of running the university and helps support research that doesn't have outside sponsorship.

However, if the contracts are funneled through a private organization, much of that money may not make it to UCSF, some worry.

Few have seen recommendations

Since the recommendations remain confidential, few at the university have seen them. One who has is Dr. Stanton Glantz, UC Med Center professor of cardiology, best known for his anti-tobacco activism. He said he doesn't like what he's read.

"It looks to me like it's a movement toward privatization of the clinical trials and moving the money out of UCSF to UCSF-Stanford, which takes it out of the realm of public accountability," Glantz said.

Karen MacLeod, president of the University Professional and Technical Employees, which represents about 3,000 UCSF workers, said the union is "very concerned," about the proposal's ramifications for labor, and plans to distribute leaflets about it next week.

The proposal also seeks to speed up ethics board approvals of experiments on humans to as little time as a week.

Another stated goal in the proposal is to have the private entity handle some conflict-of-interest issues rather than the public university. But critics contend that would shield such issues from public scrutiny and oversight.

Backers of the plan say the university needs to do more to attract clinical trials research, a booming area that is being increasingly handled by private companies as well as academic medical centers.

Besides being lucrative, clinical trials provide more research opportunities for faculty members. They also attract patients to the affiliated hospital, because it means access to some of the most cutting-edge therapies.

Complaints about bureaucracy

Many faculty members have complained that the university's bureaucracy is too slow and cumbersome to efficiently handle research contracts. A university spokeswoman said UCSF conducts $17.5 million per year in industry-funded research.

"We are concerned that this sizable portion of our research program is in jeopardy," said Lee Goldman, chairman of UCSF's Department of Medicine and a member of the committee that made the recommendation to Dean Haile Debas.

Goldman and Debas are also on the board of directors of UCSF-Stanford Health Care; Goldman is part of the organization's "leadership group." But he said he was speaking in his role at UCSF, and had not discussed the proposal with UCSF-Stanford Health Care.

The committee's report suggests a system in which UCSF-Stanford Health Care would handle the design of experimental protocols, budgetary and contract negotiations for research contracts, necessary reviews to ensure the safety of human subjects, legal services, conflict-of-interest resolution issues, and business development. It could also employ contract or leased employees on an as-needed basis, something that's of particular concern to labor unions.

Goldman likened the idea to having UCSF-Stanford act as "sales reps" for the medical school, to attract more business. He said the research contracts themselves would continue to be between the medical school and the companies, not with UCSF-Stanford Health Care.

Agency welcomes proposals

A UCSF-Stanford Health Care spokesman said he did not know whether the idea had been discussed by that organization, but said it would welcome any proposals that would increase patients' access to clinical trials.

The proposal as outlined envisions having both UCSF and Stanford medical schools use the merged entity for industry-sponsored research negotiations.

The committee's recommendations have not been made public, but were delivered to Debas in October. He has not finished reviewing them, a UCSF spokeswoman said. If Debas likes the ideas, he would send them to the faculty for review.

Still, concerns about the plan linger.

Despite UCSF officials' assurances to the contrary, MacLeod believes the university's long-term plan is to move much of the industry-sponsored research wholesale into the realm of UCSF-Stanford Health Care, where most employees are not represented by a union.

"We see it as the merged entity getting more dollars, that's the bottom line," MacLeod said.

Warren Gold, president of the UCSF faculty association, said few of its members have seen the proposal and so the group does not have a position on it.

While he said many would applaud efforts to make contract negotiations more efficient, he said he shares those concerns expressed by MacLeod and Glantz.

He also noted that for more than a year there has been debate over establishing an oversight mechanism at UCSF-Stanford Health Care for all aspects of its academic mission.



 


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Information in this article was accurate in January 2, 1999. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.