Academics' Ties to Business Muddy Disclosure Decisions

Brian Behnke In Washington's biotech debates, Irving Weissman, a professor, entrepreneur, and political activist, is among the most influential, visible, and effective advocates for the science community. He's also forthright about any potential conflicts of interest that may arise as he lobbies against curbs on scientists' freedom to conduct human embryo-related research. "I always disclose. ... Everybody in this area should do that," he says. During his long career Weissman helped create SyStemix (which marketed the SCID-hu mouse), and StemCells, located in Palo Alto, Calif. Both companies were acquired, though Weissman retains a seat on the board of StemCells. Recently, he began preparations to float a third company, to be called CellTrans. His financial interest in stem cells is straightforward and direct: The companies' research focuses on human adult stem cells--for laboratory models, rather than therapies--and his political advocacy relates directly to his professed plans to make new-and-improved models with human embryonic stem cells (hESCs). CONFLUENCE OF INTERESTS But the increasing integration of the biotech sector with academia, and the expanding relations between companies blurs formerly crisp definitions of scientists' financial interests. That integration erodes the traditional distinctions between university and industry, academic achievement and commercial success, making it difficult to separate Weissman's and other scientists' intertwined roles as professors, entrepreneurs, and advocates. Add to that the public perception of scientists as objective and oriented purely to research, and the commercial and academic relationships become all the more entangled. This integration of commerce and academia has helped spur the growth of the biotech industry, which includes many of the 3,000 companies that academics have created over the last 20 years, according to the Association of University Technology Managers. It also has brought closer to fruition new therapies that scientists once only dreamed about. But for scientists who testify in Congress or in their state legislatures, or even advise lawmakers on the science behind a debated issue, this integration of commerce and science creates an ethical minefield. Consider Paul Berg, Cahill Professor in cancer research emeritus at Stanford University. Thirty years ago, he helped develop recombinant DNA technology. Now, even in his emeritus capacity, he continues his research at Stanford's biochemistry department. He is a board member of Affymetrix in Santa Clara, Calif., and a senior adviser to one of its spin-offs, Perlegen Sciences, a genomics company in Mountain View, Calif. He also heads the public policy committee of the American Society for Cell Biology (ASCB), and he has taken a leading role in the broad campaign to fend off curbs on embryo-related research. Neither Perlegen nor Affymetrix work directly with stem cells, so Berg's involvement in them creates no conflict of interest that he is ethically obligated to report, under the guidelines of the National Academy of Science, of which he is a member. Congressional rules do not require witnesses in hearings to disclose business ties. Nevertheless, the growing confluence of interest between university re-searchers and entrepreneurs has created new economic conditions: their commercial success feeds money back into universities; patent revenue helps generate more funds for basic science; professional acclaim can boost commercial opportunities; and commercial success can advance academic standing. Advocates of university embryo research, including Weissman, say the new stem cell technology will help spur the emergence of a new wave of biotech companies, some of which will emerge from universities where Berg's colleagues still work. Such a surge in investment and funding in biotechnology companies could have indirect benefits to Affymetrix, which makes microarrays, reagents, and other tools. Some Affymetrix clients work with hESCs, and any federal laws or funding that could expand that client base could be beneficial to Affymetrix. Perlegen's potential benefits from expansion in stem cell research would be even more indirect, as its focus is narrowly on genomics for drug discovery. Still, if predicted gains from expanded stem cell research attract more investment in drug discovery, Perlegen would also benefit. TO DISCLOSE OR NOT Should scientists disclose such oblique financial relationships? For Berg, the answer is straightforward. "None of [the companies] have any relation to the issue about which I'm talking," Berg says. "Laying out for someone whatever commercial relationships totally unrelated to what I'm talking about seems totally unnecessary ... and I don't see any public interest involved." Still, he adds, "If someone asked me [to explain], I'd do so gladly." Lawrence S.B. Goldstein, professor at the University of California, San Diego, faces similar indirect conflicts. A leading hESC advocate with Berg at the ASCB, Goldstein is a founder of Cytokinetics in South San Francisco, which was formed to speed the long, expensive, and laudable effort to get results from laboratory developments into the marketplace. Neither he nor his company works on stem cells, says Goldstein, so lobbying for increased hESC funding creates no direct conflict of interest. But if advocates of hESC research are correct, the lessons learned from the hESC technology and the expected resulting flow of investment capital will help a variety of biotech companies, including companies that ASCB members have already founded or will partner to form in the next few years. If people are concerned about possible conflicts of interest, Goldstein says, they should simply ask him about his ties. However, in all his meetings with legislators and media, "I don't think anybody ever has," he adds. The lack of interest by legislators does not mean that politicians do not care about conflicts of interest. It simply means these indirect conflicts in this particular sector do not attract their attention. Politicians, to put it gently, march to a different drummer than do scientists and are not particularly excited by the hunt for new understanding, by the professional ethics of science, or by revelations about proteins and cell interactions. They are primarily interested in jobs and therapies for their constituents. That practical priority trumps routine concerns about conflicts and confluences of interest, or ethics, and management within universities and biotech companies. "I don't think the federal government should micromanage something that's for the [university's] governing board to determine," says Sen. George Allen (R-Va.), who, as former governor, boosted Virginia's three nonprofit research universities. Sen. Chuck Schumer (D-NY) says universities such as Stony Brook University are linchpins in his state's economic plans. If the price for those jobs and therapies is the conversion of professors into entrepreneurs, that's OK, Schumer adds. But in other circumstances, politicians do recognize even indirect financial relationships as potential conflicts of interest. Last November, President George W. Bush asked former Secretary of State Henry Kissinger to chair a new bipartisan panel to investigate the intelligence failure connected with the Sept.11, 2001, attacks. Two weeks later, Kissinger resigned amid sustained criticism in Washington that his chairmanship created a conflict of interest with his political consulting business, which is widely believed to include Middle East governments such as Saudi Arabia. Kissinger's critics did not accuse him of a direct conflict of interest; rather, they used a broad definition to exclude him from deliberations that could indirectly affect his reputed clients. Sen. Harry Reid (D-Nev.) told The New York Times last December: "There were too many conflicts of interest for him to lead this task." Kissinger quit because "he realized he couldn't hide [the conflicts] anymore," Reid declared, according to the Times. Public advocacy for environmental regulations has similarly focused on the business ties of the scientific advisers to both federal and state lawmakers. Reid, like many other legislators, applies a somewhat looser standard for the university research sector, which has long been favored by his party. Throughout 2002, Reid staunchly supported legislation that would ban the birth of human clones but also allow continued cloning of embryos for research. "Therapeutic cloning will lead very quickly to abolishment of Parkinson's and other diseases," he declared in one speech. But when he was asked recently about the tangled interests of the scientists who lobby for his cloning-for-research bill, Reid pled ignorance about his scientist-advisers. "I'm not a scientist. All I know is that we have to have scientists who are without any conflicts." It would, he said, create "ethical problems" if research advocates are tied to a pharmaceutical or biotech company. That is Washington boilerplate, stated, perhaps, for the sake of his constituents. What matters is that Reid next said he had not inquired if scientists testifying in Congress had any commercial ties. Thus, he was willing to criticize Kissinger for not disclosing business details, but he has not made any moves to disclose the financial interests of the people whose aims comport with his own political goals. THE RULES Congress has its own disclosure rules, but they offer no assistance to scientists. The rules require federal contractors who testify to disclose how much money they've earned from the US government, but offer no guidelines for other people who give statements to Congress.1 Edward Benz, president of the Dana-Farber Cancer Institute at Harvard Medical School, advises scientists to tell all. "People should disclose anytime that they have something that might bias their remarks," says Benz, who served with Weissman on a federal planning board that helped formulate federal policy on stem cells. "It is very, very difficult to keep [business and scientific interests] separate ... in every area of medical research." Weissman, Berg, Goldstein, and many other scientists have adopted a clear vision of what constitutes a conflict of interest. It focuses on conflicts between narrow scientific questions and directly related business deals. So far politicians agree. But politics changes, and politicians may choose, for their own reasons, to expand the definition of what constitutes a conflict of interest. Kissinger, the former chairman-to-be of the Sept. 11 panel, understands how quickly those changes can come. Neil Munro (nmunro@nationaljournal.com) is a reporter in Washington, DC. 1. T.P. Carr, "House committee hearings: Witness testimony," Congressional Research Service, Feb. 12, 2001.

Academics' Ties to Business Muddy Disclosure Decisions

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