Conflict-of-Interest Fears Rise as Universities Chase Industry Support

By GOLDIE BLUMENSTYK

What if academe had a stricter ethic of disclosure for its financial ties to industry? In one case at least, says a professor of medicine, some lives might have been saved.

More than a year before the appetite suppressants known as "fen-phen" were pulled from the market, Stuart A. Rich and others published a study in The New England Journal of Medicine showing that such drugs could lead to a potentially fatal lung condition. In that same August 1996 edition, the journal also ran a commentary by two other academic physicians that minimized the study's conclusions about the health dangers of the drugs.

What readers were not told was that each of the authors of the commentary had been paid consultants to companies that make or distribute similar drugs.

"I was outraged when I saw that," recalls Dr. Rich, now a professor of medicine at Rush Medical College, in Chicago. "The study was the only scientific study that said these diet pills kill people."

The two authors have since said that they had disclosed what they thought was necessary. The journal's editors say they would have found different commentators -- to avoid any question of bias -- if the extent of the authors' involvement with the industry had been clearer.

Although the conflict of interest quickly became public in some news accounts, and in the journal's own editorial five weeks later, Dr. Rich contends that the negative commentary kept the study from receiving the attention it deserved.

"We were on the mark," he says. "Now we're going to have to stand by and do a body count."

Many higher-education watchdogs share a similar frustration. They say the conflict-of-interest policies and standards of disclosure that universities rely upon don't do enough to protect academic freedom or the integrity of research in an environment where corporate interests are playing a growing role.

It's no longer safe to assume that academic scientists are "disinterested," says Sheldon Krimsky, a professor of urban and environmental policy at Tufts University, who studies disclosure practices in scholarly journals.

"And we don't even have the tools in our society for asking the question," he adds.

In recent months, most of the questions have been about tobacco research, with the revelations in late 1997 -- and again last month -- of secret files detailing ties between tobacco companies and academe.

In one instance, first reported by The Dallas Morning News, the University of Texas Health Center at Tyler even agreed to allow a professor to conduct secret research for tobacco-company lawyers over 11 years, in return for nearly $1.7-million.

But as the diet-pill conflict and several other recent cases have shown, tobacco money isn't the only kind of industry support that can be troublesome.

Whether it's drug-company grants that restrict publication results -- as occurred at the University of California at San Francisco a few years ago -- or sponsorships from the oil and coal industries for researchers known for minimizing the threat of global warming, or the increasingly common practice of allowing medical-school professors to take research grants from companies that also pay them as consultants, entanglements with industry can be problematic.

Even so, institutions are working harder than ever to land corporate financing, and pressing their faculty members to consult with industry.

At most colleges and universities, the main tool for insuring control over corporate money is the conflict-of-interest policy. Since October 1995, institutions have been required to have such a policy to receive grants from the National Science Foundation or the National Institutes of Health. Some already had policies in place.

But the policies vary greatly in what kinds of potential conflicts that professors are required to disclose, and in how those conflicts are handled. What's more, although the policies are based on the principle of disclosure, "disclosure is all relative" in its extent, notes Mildred K. Cho, an ethicist at the University of Pennsylvania.

At most private institutions and many public ones, the professors' disclosures are kept private. The head of the conflict-of-interest committee at the University of Pittsburgh says that disclosure filings there are kept "under lock and key." In some states, however, including California, Indiana, and Washington, all or part of the disclosure documents are available under public-records laws.

A few institutions, including the University of California at San Francisco and the University of Washington Medical School, do sometimes require professors to make potential conflicts public in their journal articles and presentations. U.C.S.F., for example, used that conflict-management technique recently in hiring Frank McCormick, a founder of Onyx Pharmaceuticals, as head of its new cancer institute. Mr. McCormick, who now directs a $1.1-million grant from Onyx at the university, also agreed to resign from two positions with the company that would have related to his academic work.

Ms. Cho, an associate professor of ethics at Penn's Center for Bioethics, is analyzing conflict-of-interest policies at the 100 universities most heavily involved in biomedical research. Her study, which is self-financed, will also look at other kinds of policies that relate to company-financed research, such as how long a university would delay publishing results from such research at the request of the company.

"A lot of institutions are trying to recast themselves as industry-friendly," says Ms. Cho, who wants to know if that trend has led to a tightening of controls, to give better protections to the institution and researchers -- or to a softening of standards, to attract sponsors.

University leaders have a sense that "as soon as one institution gets stringent, they lose business, quote-unquote, to another institution," she says.

A study like hers can hardly cover all of the problem areas, though. Some corporate research arrangements, she says, "end up slipping through the cracks" of a conflict policy, say, an off-the-books study in return for a "gift" of scientific materials. Those kinds of relationships are proliferating, according to a recent study by researchers at Massachusetts General Hospital, in Boston. Many such deals also involve demands from sponsors, such as delaying publication.

Nor can a policy address the concern, raised by environmentalists and others, that companies deliberately select certain researchers to do studies on controversial topics because those researchers seem sympathetic to their cause. In other instances, researchers themselves agree not to try to have their work published -- a tactic said to be used sometimes when drug trials produce results unfavorable to the sponsoring company.

"There are not a lot of rules that you can make to force people to publish things," Ms. Cho notes.

What, then, do university policies regulate?

At U.C.S.F., professors are for-bidden to work on a clinical trial if they have a conflict of interest in the drug or device to be tested. The University of Washington says it might allow such arrangements, but only with approval. Washington follows a zero-tolerance standard in cases where patients or other human subjects are involved; its rules say any financial interest at all, even a minor one, must be disclosed.

Harvard Medical School says it typically forbids professors to accept sponsored-research grants from companies in which they hold equity. The rule covers all full-time and part-time faculty members.

The University of Michigan limits the amount of money its medical-school professors can receive from consulting for drug companies and testifying as expert witnesses to 25 per cent of their salaries. Its rule covers only full-time faculty members, although it may be expanded.

No matter how their rules are applied, though, universities depend heavily on voluntary compliance.

At Michigan, officials say, a professor of urology violated rules on consulting and disclosure for years while he was receiving grants to study a new surgical treatment for enlarged prostates. The company that financed his research paid him as a consultant, and he later endorsed its products at medical conferences.

The situation came to light only when the professor, Joseph Oesterling, was found to have double-billed the university for travel expenses. He resigned in July 1997. Dr. Oesterling did not return phone calls seeking comment.

The scrutiny that faculty members receive from their colleagues also helps to keep the process honest, says C.K. Gunsalus, associate provost at the University of Illinois at Urbana-Champaign, who has been on several national committees on scientific integrity. "If someone is known for doing schlocky, meaningless research," Ms. Gunsalus says, he or she won't receive tenure or get promoted.

But "the best practice is for there to be a disclosure" of a researcher's financial interest, she adds. "If it didn't influence you, why is it a problem to disclose it?"

Ms. Gunsalus, along with other university officials, says an appropriate place for such disclosure is in the journals that publish the research. But journal editors -- even those whose publications themselves follow strict policies on conflicts of interest -- say it's unrealistic to place the burden for policing the system on them.

"We don't have the mandate," says Drummond Rennie, a deputy editor at The Journal of the American Medical Association, which does ask its authors to disclose any conflicts. "If we think it's important, as often as not, we disclose it to the readers. I'm sure you'll find a whole lot of journals that don't."

Dr. Rennie says the journal doesn't have the resources to examine every disclosure for thoroughness, however. "We are not an enforcing organization. If people choose to lie, there's nothing we can do about it. We're not the F.B.I."

Two years ago, Mr. Krimsky, the Tufts professor, did a study of journal disclosures. With three colleagues, he dug into the industry connections of the authors of nearly 800 scientific papers published in 14 journals in 1992.

In one out of three papers, at least one of the chief authors had a financial interest connected to the research. And many of those circumstances were not disclosed in the journals, where readers could see them. He is now examining the disclosure policies of 1,400 of the most widely cited and influential scholarly journals.

Many journals have tightened their policies since 1992.

Last year, the International Committee of Medical Journal Editors recommended a conflict-of-interest policy for all authors, reviewers, and editors. It says conflicts can involve financial interests and can also arise for other reasons, "such as personal relationships, academic competition, and intellectual passion."

Some 500 journals say they follow the committee's general guidelines, but it is difficult to know how many strictly adhere to the conflict policy.

A recent study, designed to measure how drug-company money might influence scientists, points directly toward the need for disclosure, advocates say.

The study found that 96 per cent of the researchers who wrote favorable articles about a controversial class of drugs for treating hypertension and angina also had financial ties to the makers of those drugs. Conflicts were disclosed in only two of the 70 papers studied. Among those who published articles critical of the drugs, only 37 per cent had financial ties. The study ran in The New England Journal of Medicine in January.

At the journal itself, editors toughened their own enforcement after the diet-pill case. To help insure that interested parties do not write opinion pieces, the journal now requires authors who write commentaries or reviews to sign a statement attesting that they "have no current, recent past, or planned future financial associations (such as equity interest, consultancies, or major research) with a company that stands to gain from the use of a product (or its competitor) discussed in the editorial or review."

Many journals in other fields aren't as stringent. The Journal of Marketing, for example, does not require authors to disclose their conflicts even in studies of societal importance, such as studies on the influence of tobacco advertising.

When researchers receive direct support from a company for their research, that information does often appear in a journal. But those acknowledgments typically don't specify the amount of money involved, and so they too are inadequate, says Thomas J. Moore, a senior fellow in health policy at the George Washington University Medical Center.

Researchers like to think that they are not influenced by their financial ties, "but the pressures may be too subtle for them to realize," he says.

The lack of disclosure beyond the world of journals is an even more significant problem, some say, now that universities increasingly accept corporate financing for research on topics of public concern, such as pollution or gambling.

"There is nothing inherently wrong with industry-funded research," says Ross Gelbspan, whose 1997 book on global warming criticizes several professors for failing to disclose the financing of their research by coal and oil interests. The book, The Heat Is On, says the professors' work was later used in a media "disinformation" campaign in an attempt to discredit theories about the danger of climate change.

"A specialized audience has more of an ability to evaluate stuff" when it appears in a journal alongside data, says Mr. Gelbspan. But when professors write op-ed articles or give speeches and don't disclose how their work is financed, readers and listeners are deprived of information they might use to judge the subject, he argues, adding that newspapers should require such information.

That "sounds like an appealing argument," but it's completely impractical, says Robert C. Balling, director of the office of climatology at Arizona State University and one of the professors cited in the book. "I don't know how you do full disclosure every time you do an op-ed."

Mr. Balling says he's received $408,000 in research support from fossil-fuel industries in the past 10 years -- and probably twice as much from federal sources, including the National Oceanic and Atmospheric Administration.

He indicates the sources of his support in scholarly works, he says, but not in the op-ed pieces he occasionally writes, including some that have appeared in The Wall Street Journal. In those, he's identified merely by his academic title; at least one also noted that a book he wrote on climate change was published by the Pacific Research Institute. Those familiar with the institute would know that it is a conservative think tank.

For his research, as well as that of others, Mr. Balling says, it's the ideas that matter: "Who funded it seems less relevant to me than what he's saying."

The industry support for Mr. Balling does "look a little funny," says Arizona State's vice-provost for research, Jonathan Fink. But there's probably nothing the institution could do, or should do, to deal with that; to intrude would violate academic freedom, he says.

If anything, says Mr. Fink, he wishes that more professors on the campus were involved in global-warming research, so that Mr. Balling "isn't the only person that people turn to when they want to find out what A.S.U. professors think."

Nicholas Steneck, a professor of history and of ethics in engineering at the University of Michigan, says such a wider view might, in fact, be a good approach for academe. While the conflict-of-interest situations are worrisome, he says, "we really do not know whether the cases we see are the tip of the iceberg, or are all that are out there."

Mr. Steneck, who studies research integrity, says that along with making disclosure "more transparent and visible," institutions should examine broadly their sources of financing for research.

If academics looked at the major research universities and asked, for example, "How much are they serving the poor?" he says, "I'm not sure our records would look particularly good."

Ultimately, he says, maybe that's just the kind of disclosure that would make a difference.

• "Study Says Many Scientists Accept Research-Related Gifts From Corporations," 4/10/98
• "Academic Medical Centers Race to Compete in the $3.2-Billion Drug-Testing Market," 3/20/98
• "University-Industry Research Must Get Closer Scrutiny," Opinion, 8/1/97
• "Drug Study, Long Delayed by Legal Threat, Is Finally Published," 4/25/97
• "Study Shows Financial Ties of Research-Paper Authors," 2/21/98
• "British Drug Company Prevented Publication of Research," 5/10/96
• "Study Finds Companies Demand Secrecy on Research They Finance," 2/16/96