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