Most medical researchers have a mantra about relationships with industry, financial and otherwise: disclose, disclose, disclose. It’s a position with which most professors (and journal editors) in other fields -- even those without life-and-death implications -- agree. But should colleges and universities be held to the same standard, and just how much disclosure is enough?
Those are questions faculty members at the University of California at San Francisco are raising this week, ahead of a decidedly controversial medical conference co-sponsored by the university and the Manhattan Institute for Policy Research, a conservative think tank that the professors view as anti-science and pro-tobacco. The university meanwhile, says that such questions are important but that the event in question is about the future of medicine, not partisan politics.
On its face, today’s joint conference, called “Data and Technology: Keys to Precision Medicine and 21st-Century Cures,” is pretty innocuous. Both the university’s and the Manhattan Institute’s logos appear at the top of invitation, along with a list of speakers including professors from San Francisco and elsewhere and representatives of the health care and technology industries.
The finer print says that “remarkable discoveries” are happening the field of precision medicine -- or advanced, individualized health care treatments -- but that “outmoded legal, administrative, funding/reimbursement and regulatory policies pose barriers to building the massive connected databases and analytic tools that will be needed to identify, test and deliver” such care.
The invitation further signals a political -- albeit nonpartisan -- agenda, saying, “President Obama and bipartisan Congressional leaders have signaled their support for initiatives and legislation that can accelerate the development of precision medicine technologies and strategies.”
But some faculty members on campus say that level of disclosure about the political nature of the event isn’t enough, and that the invitation should include information about what the Manhattan Institute is and does -- along with the fact that it pitched the event to the university. Others question the university's participation in the event altogether.
“We’re talking about the politicization of the university setting, with the university getting involved in a very partisan organization that is fundamentally anti-science,” said Stanton Glantz, a professor of medicine and American Legacy Foundation Distinguished Professor of Tobacco Control, who did pioneering research on the health effects of smoking and secondhand smoke. Glantz also helped San Francisco build Legacy Tobacco Documents Library, a massive archive of tobacco industry communications about the antismoking movement. Documents suggest that the Manhattan Institute -- which promotes policy that is often critical of government regulation of health care, the environment and other areas -- accepted money from the tobacco industry and worked to reframe the antismoking debate to emphasize personal choice, not science, over the past few decades.
The institute also has published policy papers criticizing the government’s regulatory stance on precision medicine. In “Unlocking the Code of Health: Bridging the Gap Between Precision Medicine and [Food and Drug Administration] Regulation,” released earlier this month, the institute argues that the F.D.A. “has been slow to incorporate biomarkers into the regulatory procedures for drug approval and, as a result, has significantly slowed the development of safe and effective treatments for many diseases.”
The paper recommends that the F.D.A. retain ultimate regulatory authority, but that it refer much of the grunt work to panels of experts equipped to more efficiently “develop substantive standards for the use of biomarkers in the drug-approval process. Separate expert panels should be convened to develop standards that address the statistical tools needed to analyze biomarker data.”
Although the Manhattan Institute policy on precision medicine is not without supporters, Glantz said the think tank is part of a larger problem of partisan organizations “parading” as legitimate research partners. For that reason, he said, the university has no business co-sponsoring an academic event with any such organization, from either side of the political aisle. His criticism wouldn't necessarily apply to a faculty member opting to work with the institute, but is related to the university appearing to declare the institute a worthy partner.
"I’m not saying they should not be allowed to set foot on campus, but they should not be allowed to do so as a wolf in sheep’s clothing, with an institutional endorsement,” he said, noting that the institute -- not the university -- originally pitched the idea to Keith Yamamoto, San Francisco’s vice chancellor for research.
Earlier this week, Glantz and fellow members of board of the U.C.S.F. Faculty Association, an independent organization for professors, sent a letter expressing their concerns to Yamamoto, who is organizing the conference on campus.
The letter says that the Faculty Association is concerned about the Manhattan Institute’s “regrettably long history” of “subverting scientific efforts to research the adverse health impacts of tobacco and climate change,” as documented in the university tobacco archive. The letter says that the association does not oppose the university’s planning a conference with the institute due to its “conservative bent,” but rather because “we do not believe that they adhere to the principles of academic freedom and free exchange of ideas based on evidence that is central to scientific discourse.”
The letter notes that it is particularly inappropriate that the institute -- not the university -- is collecting R.S.V.P.s for the event, and urges Yamamoto to drop the university’s sponsorship of the event.
Leaders of the university’s Academic Senate, including Ruth Greenblatt, a professor of clinical pharmacology, senate co-chair, also reached out to Yamamoto in concern. Greenblatt said she wasn’t necessarily opposed to the university co-sponsoring the event but that the invitation should at least include more information about the Manhattan Institute.
“They do major political policy advocacy work related to F.D.A. regulation,” she said. “So I was concerned the announcement that went out doesn’t really indicate that they’re an advocacy group.”
Greenblatt said health scientists are supposed to “disclose, disclose, disclose” their affiliations with industry sponsors, and that the same principle should be applied by the university here. She noted she was previously unaware of the Manhattan Institute's work, and that her opinion had nothing to do with politics; even an advocacy organization as sympathetic as Mothers Against Drunk Driving, for example, should include its position on event notices, she said, so that participants can be informed.
The Manhattan Institute in a statement said that it holds events on some 50 campuses per year, all of which are aimed at "moving the discussion forward" on a number of issues. It referred additional questions to Yamamoto, who said he was more than willing to engage in a universitywide dialogue about levels of disclosure regarding sponsorship of events -- but not “36 hours before the meeting." He also denied that the meeting had any partisan bent.
Yamamoto said that he was in talks during the last Congress with the House Energy and Commerce Committee about the future of precision research, and that those talks have now evolved into proposed legislation on the matter. Working with members of the committee, the Manhattan Institute is helping organize of series of panel discussions at colleges across the country -- he said one already has taken place at Tufts University -- to gather expert input on the topic. So although he was approached by the institute to host the event, Yamamoto said he has been entirely in charge of inviting speakers and creating the discussion agenda. He also said he doubted whether the institute was collecting R.S.V.P.s for any of the “nefarious” purposes that have been alleged by faculty critics, including a desire on the part of Manhattan to claim various high-profile attendees as political allies.
“I think this is a totally appropriate thing for the university to be doing,” Yamamoto said, adding that not to participate would be a missed opportunity for the medical sciences campus to participate in the Congressional initiative, called 21st-Century Cures. “The institute may have politics with which some may vehemently disagree, but they are not really germane in this case, in my opinion.”
Yamamoto added, “The faculty concerns that have been raised I think are legitimate matters for us to debate, in terms of setting campus policy, but I don’t think we should be doing it in a reactionary way.” He said the event this afternoon will go on as planned, and that he hopes it will be a valuable use of everyone’s time.
The American Association of University Professors says that it’s a matter of academic freedom that professors retain the right to partner with whomever they choose for research -- as long as they freely and clearly disclose the relationship. But what about institutions? Robert O’Neil, former president of the University of Virginia and a legal expert on academic freedom, said the same logic should govern institutional relationships and sponsorships.
“I would also urge that such support may not be allowed to taint the objectivity or integrity of the grant or subvention, or permit donor/sponsor involvement in selection of, e.g., a faculty grantee or participant,” he said via email. “If this institute avoids such entanglements I believe its support should not be refused or declined.”
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