Landmark `Consensus Statement' On Biomedical Research Support Is Greeted By Mixed Reactions

Support Is Greeted By Mixed Reactions Author: BARBARA SPECTOR, pp.1 Date: May 30,1994 Some observers regard the plea to Congress, signed by 156 organizations, as an urgently needed document, but others see flaws in it A "consensus statement" advocating increased medical research funding by the United States government--endorsed by 156 institutions, associations, and companies and presented to Congress earlier this month --will be a significant addition to the national health-care-reform debate, say those who have signed the document. The signatories say its message will be particularly effective because such declarations are rarely made jointly by diverse sectors of the research community. Some health-policy specialists agree with this assessment of the statement's importance, predicting that its language will likely appeal to President Clinton. But as the declaration was being delivered to members of Congress, objections to it were coming from several quarters. A number of long-time health-policy watchers, for example, believe that the individual concerns of the signatories are too blatantly heralded in the statement and foresee a backlash from politicians inundated with pleas from special- interest groups. Others say the document does not make its case in a novel way and thus is likely to be ignored. Yet some critics disagree with these predictions, saying that the statement is liable to be welcomed by government officials--but they contend that lawmakers would be misguided in heeding its recommendations, which they say are not in the public interest. The declaration grew out of a March 9 forum held at the Carnegie Institution in Washington, D.C., and attended by officials from scientific societies; voluntary health associations; biotechnology and pharmaceutical companies; medical, dental, and nursing schools; and hospitals. The meeting was organized by Research!America, an Alexandria, Va.-based research-advocacy organization, and chaired by Leon Rosenberg, president of the Bristol-Myers Squibb Pharmaceutical Research Institute in Princeton, N.J. (see Commentary, page 13). The statement was hand-delivered to every member of Congress on May 3; subsequently, it was given to staffers in the Clinton administration and various federal agencies. Asserting that "too many Americans are suffering and dying needlessly because, as a nation, we don't invest enough in medical research," the statement notes that such research "provides high-quality, long-term employment for more than a million people." The document cites a poll conducted for Research!America by New York-based Louis Harris & Associates that found "a majority of Americans want the nation to invest more heavily in medical research." It concludes with recommendations, including calls to "incorporate the promotion of medical research as an integral element of health-care reform" and "encourage, do not obstruct, the discovery and develop- ment of innovative and effective pharmaceuticals, devices and reagents, by private industry." (For the full text, see Opinion, page 12.) Research!America president Mary Woolley says the message of the statement is twofold: to explain effectively "how health research can help the public interest"; and to counter "a perception out there that the research community fights within itself and doesn't agree on a whole range of issues." The document, she says, will aid advocates of research as they make their individual cases to Congress, the Clinton administration, and others working on health-care reform policy: "They now have words to use that they know are shared by members of the diverse research community." The signatories' ultimate objective, Woolley says, is "getting past the year-to-year, crisis mentality" that she says has characterized research funding over the past decade. "If we are successful, bench scientists will be allowed to pursue science based on scientific opportunities, secure that what they're doing is supported by the public, and everybody will win," she says. Robert C. Young, president of the Fox Chase Cancer Center in Philadelphia, which endorsed the statement, points out that the need for basic scientific investigation is "not self- evident to many people in this country, and it's nave to expect that it is." It's no longer realistic for scientists to "expect that they can qui-etly work and people will respect the importance [of research]," Young says. "Basically, we are not joiners, but we will do anything to support research," says Constance Lieber, president of Great Neck, N.Y.-based NARSAD, or the National Alliance for Research on Schizophrenia and Depression, of her group, another signatory. "I think it's a great achievement to have one organization--Research!America--get these organizations together. They all have their own private agendas but can agree on one central issue." But some observers worry that the statement may subvert its own objective. "I'm in general agreement with the goals of this action--to raise awareness of the need for greater public investment in research," says Denis J. Prager, director of health programs at the Chicago-based John D. and Catherine T. MacArthur Foundation. "But I'm skeptical about the effectiveness of this particular document, in which the recommendations are transparent reflections of the concerns and fears of the signatories. "I'm concerned that, because of the transparency of the interests which it represents, it may actually have the opposite effect from what is intended." However, Carl Feldbaum, president of the Washington, D.C.- based Biotechnology Industry Organization (BIO), which endorsed the statement, does not fear being viewed as representing a special interest. "We're all interest groups in the eyes of the administration and Congress," he says. It was no easy task to produce a document to which 156 organizations were willing to add their imprimatur, say those involved in the effort. Woolley says it took about four weeks to revise the statement according to the signatories' comments on a series of drafts--a process she originally expected to take 10 days. "I wouldn't say it was easy," says Feldbaum. "It got down to the single-word level of wordsmithing." One issue that is not mentioned specifically in the document is the use of animals in research, although, according to Gregory Maas, chief executive officer of Incurably Ill for Animal Research (iiFAR) in Lansing, Mich., general support for it is alluded to in references to "... the need to comply with state and federal regulations" (including animal-care regulations) and "persistent lack of understanding among the general public ... of the interconnectedness of medical research and quality health care" (which refers in part to public support for animal- rights causes). "It would have been more to our liking to have something a little stronger in the statement, but it's [just] one issue," says Maas. "When you're trying to come up with a consensus statement that diverse groups can agree on, there's some give and take that has to occur." Maas says that although he does not believe the public is sufficiently informed about the benefits of animal research, iiFAR is "trying to bridge that gap. We need to show the connection between biomedical research and health care. For the public to be more involved, they need to have a better understanding of the research-funding process." Not all of Research!America's member organizations are happy with the text of the statement--with the nature of the criticisms reflecting the umbrella group's diverse constituency. Richard De-Schutter, president of Chicago- based Searle & Co., says that although his company considers itself a signatory because it is a member of the Washington, D.C.- based Pharmaceutical Manufacturers Association, which endorsed the document, "I told Mary [Woolley] I was disappointed that the statement doesn't go further in underlining the importance of free-market pricing as a mechanism of innovation in the development of drugs." Also critical of the statement, but taking an opposing view to DeSchutter's premise, is Abbey Meyers, president of the New Fairfield, Conn.-based National Organization for Rare Disorders, which declined to sign the statement. "The wording in the draft seemed to be so against health reform altogether; it wasn't simply addressing medical research," says Meyers. "Our interest is to protect patients, and it's not in patients' best interest to come out with a statement that's anti-reform and pro-industry. No matter what miracles [researchers] come up with, it won't do the patients any good if they can't afford them. "It's important to keep scientists in biomedical research, but there are other ways of doing it than to come out with a document that essentially complains about change," Meyers says. Woolley says that the document's drafters "came down, we believe, in the middle" of the viewpoints expressed by DeSchutter and Meyers. Drafters of the document made a concerted effort to "avoid polarizing statements," which is why the statement does not take a position on issues such as the role of market forces in drug pricing, she says. The Research!America president says she believes that the fact that objections to the statement have come from a drug company executive as well as a patient advocate is a tribute to the integrity of the consensus-building process. "As it was going on, it was suggested that Research!America was being manipulated by one segment or the other," Woolley says. "I think we did achieve a balance." However, some observers outside of the Research!America fold do not see such a balance in the statement. Sidney Wolfe, a physician and director of the Washington, D.C.-based Public Citizen Health Research Group, which advocates controls on the delivery of health care, says the document reflects unhealthy ties between pharmaceutical firms and the public sector. "[The National Institutes of Health] is doing some clinical trials that either shouldn't be done or should be done by drug companies; medical schools have become closer and closer to industry," says Wolfe. The statement is "evidence of this close relationship," he says. "I'd be happy if funding for academia were increased so they weren't as dependent as they are now on industry," he says. "This is not the agenda that [drug companies] have in mind." Robert Bell, a professor of economics at Brooklyn College, City University of New York, and author of Impure Science: Fraud, Compromise, and Political Influence in Scientific Research (New York, John Wiley & Sons Inc., 1992), is fearful of the statement's recommendations. "What it comes down to is more subsidy and less regulation for medical research--like the deregulation of the savings and loans," he says. "We should be moving in the direction of much greater checks and balances. To my mind, it's a scam to get American taxpayers to support the multinational activities of drug companies. "If all of these recommendations were implemented, it would turn what's left of peer-review science into an enormous pork feeding ground," Bell says. He adds that even the goal of more funding for medical research may not be a desirable one: "More money doesn't necessarily make for better research. More money means huge organizations, big construction, big contractors. Who are the big contractors going to be? The drug companies. They'll be the Pentagon contractors of medical research." Despite the dangers inherent in the recommendations, Bell predicts, "What's discussed in this consensus statement is going to get a lot of support from the White House; I would be surprised if it didn't." Yet some observers who strongly agree with the statement's call for more funding for medical research have doubts about the way its message is expressed. "There's absolutely nothing new here," says one experienced Washington lobbyist, speaking on condition of anonymity. "This has been the medical-research agenda for a couple of decades. It's the same old way of doing business--and the straits medical research is in speaks for itself about how effective it's been." Counters BIO's Feldbaum: "The message is not as new as the spectrum of messengers who are delivering it. If we continue working together, we will have political impact. Coalitions are the best way to take action." Peter Feinstein--a founder and a member of the board of directors of the Massachusetts Biotechnology Council and president of Feinstein Partners, a consulting firm for the biotech industry based in Cambridge, Mass.--although not a part of the consensus statement coalition, agrees with Feldbaum that the diverse alliance is significant. "A parallel may be the War on Cancer put together during the Nixon administration," Feinstein says. "They managed to get $100 million put into the NIH budget. The key thing is the combination of the academic and clinical Ph.D. and M.D. community. This is not a coalition that [ordinarily joins] together. The fact that it is together has some significance." Feinstein also predicts that the signatories' message will not fall on deaf ears in Washington: "This is the kind of thing that Clinton is liable to like. This is a nice thing to add to [the health-care] debate, and this is a good time to bring it up." One longtime advocate for medical research says the key to the effort's success will be what happens next. "This is a laudable effort by a lot of groups, but, as usual, the proof is in the follow-up," says Terry Lierman of Washington-based Capitol Associates, a government-relations firm. "I would hope that these groups would spend an equal amount of time getting their members and colleagues outside [Washington] involved with decision-makers-- that's where the impact will really be felt. A lot more steps have to be taken with consumers before they're ready to get involved with Congress and policymakers to support innovation in health-care reform." Feldbaum, himself an old Washington hand--he was formerly an aide to Sen. Arlen Specter (R-Pa.)--agrees. "These arguments have to be made in a very strenuous and calculated way," he says. "Human beings afflicted with certain diseases have to testify. Members of Congress are human--they respond to human approaches, not to dry, abstract approaches." The effectiveness of the statement, he says, "depends on who delivers it and how the statement is delivered." Whether the statement ends up making waves or being a washout on Capitol Hill (at press time, none of the senators or representatives contacted by The Scientist had had a chance to review the document), it is bound to be quoted repeatedly in a variety of contexts; only time will tell whether the effort is ultimately viewed as a success. In politics, "change is inevitable; this is one way of dealing with it," says Daryl Chubin, division director for research, evaluation, and dissemination at the National Science Foundation's education and human resources directorate. "You inject this into the political arena, and it kind of swishes around in there--people bring it to their representatives, use it in testimony. By being out there, it creates an opportunity for a kind of experiment."

Landmark `Consensus Statement' On Biomedical Research Support Is Greeted By Mixed Reactions

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