Science? Many from academia and industry dispute an NCI scientist's charge that confidentiality agreements restrict the free exchange of information.
|CONCERNED: NCI's Steven Rosenberg worries that research agreements promote secrecy among scientists.|
Rosenberg, chief of surgery at the National Cancer Institute, worries about confidentiality agreements that scientists sign with corporate funders in order to use company materials. He contends that these arrangements may unnecessarily restrict the exchange of information among scientists.
Secrecy in research "is underappreciated, and it's holding back medical cancer research-it's holding back my research," says Rosenberg. "Some people are not sharing reagents, and it seems to be getting worse. It's an issue that's in the medical closet, and we have to bring it out."
In a commentary February 8 in the New England Journal of Medicine (S.A. Rosenberg, 334:392-4, 1996), he suggests that such agreements are becoming excessive and are undermining medical progress.
Rosenberg's article accompanies a report of a survey of 210 companies that fund scientific and medical research (D. Blumenthal et al., New England Journal of Medicine, 334:368-73, 1996). The study, led by David Blumenthal, chief of health policy research at Massachusetts General Hospital, found that many pharmaceutical and biotechnology companies demand that university collaborators keep research results secret for several months while the companies attempt to commercialize the work. Such agreements can interfere with scientific progress by preventing the free exchange of information, Blumenthal told the Washington Post (R. Weiss, Feb. 8, 1996, page A6).
Yet many scientists disagree. They say that industry support has been extremely beneficial, and has little impact on their ability to publish, talk about their work at scientific meetings, and collaborate with colleagues. Scientists and universities negotiate equitable terms in their collaborations with industry partners regarding research support dollars, publications, and patents, they say. Most institutions, they contend, have developed standard contractual language to deal with corporate funders, greatly simplifying the process and ensuring mutually beneficial relationships. Corporate confidentiality requirements may be quite reasonable given a company's considerable investment and need to be competitive, they maintain.
"In general, there has been open discussion with investigators as to our results, and we demand that as scientists we can publish the results when we want to," explains oncologist Nicholas Vogelzang, a professor of medicine at the University of Chicago Medical Center. However, he notes, "there will always be some friction. Companies are motivated by financial concerns and bottom lines. Doctors are motivated by the biological or scientific or moral aspects."
The Blumenthal survey findings seem to support Rosenberg's contention. In terms of protecting the confidentiality of research data, 82 percent of the companies surveyed required investigators to keep research findings confidential until patent applications are filed. The authors call this "standard practice among most academic institutions."
About half of those surveyed noted that information from academic research may be kept confidential longer than necessary for patent protection, often as a condition of an agreement.
Rosenberg is concerned about confidentiality agreements that, he contends, inappropriately delay publication of medical research and discourage discussion at scientific meetings.
Typically, he explains, "if you want a reagent from a biotech company, they ask you to sign confidentiality agreements. Often they require you agree that you keep any research result you obtain using that reagent confidential for three years." In one case, Rosenberg was asked to remain quiet for 10 years.
Confidentiality agreements are hardly unusual, maintains Laurence Reid, associate director of business development at Millennium Pharmaceuticals in Cambridge, Mass. "Anytime a commercial entity has a relationship with an academic institution, there will be some measure of confidentiality involved to protect the company's rights."
Rosenberg, however, contends that while the notion of secrecy among researchers isn't new, it's been getting worse. He blames increasingly scarce federal funds for medical research along with rising competition for those fewer resources. According to the Blumenthal report, industry provides between 10 percent and 11 percent of total research support at universities. In 1994, the National Institutes of Health spent $6.2 billion, whereas industry's contribution was roughly $1.5 billion.
"I've never signed one [a confidentiality agreement]-I don't think any scientist should," Rosenberg says. "If they send me interleukin X and I use it and find something very important, they're asking me to sign something that says I will not reveal the results for several years. How can any scientist-any doctor-agree to that?"
When researchers don't share information, he says, effective new treatments may be delayed, sometimes costing lives: "Whereas that's not the intention of people who keep secrets, that's the consequence."
Rosenberg says that scientists "don't like to discuss these situations because they find them embarrassing."
But he isn't about to suggest that drug companies shy away from profits. Rather, he proposes that scientists simply not sign confidentiality agreements, which he terms "antithetical to the morality and credo of science."
Says Rosenberg: "We need to get scientists and lawyers to sit down and develop laws to protect intellectual properties that allow sharing. There have got to be ways to do it."
Many scientists lament the fact that confidentiality agreements can chill open discussion among colleagues. "It used to be that if you published you could ask about results, reagents-now you have these confidentiality agreements," comments Nobel Prize-winning biochemist Paul Berg, a professor of biochemistry at Stanford University. "Sometimes if you accept a grant from a company, you have to include a proviso that you won't distribute anything except with its okay.
"It has a negative impact on science," he declares. Withholding of research results at meetings "is probably worse than it used to be, but there's always people who don't tell the whole story because of competition," says Berg, who is director of Stanford's Beckman Center for Molecular and Genetic Medicine.
Rosenberg argues that confidentiality agreements and the resulting secrecy are "making scientists more competitive among scientists, as opposed to competition of the scientist against disease, which is how it should be.
"The problem is, what is medical research about? To prevent human suffering and premature death from disease. It's not a field in which competition among scientists is acceptable. All of the competition should be against disease. It's not okay in medical research."
At the same time, Berg speculates that competition for grants, publications, patents, and jobs may contribute more to secrecy than ever before. "Certainly it's changing the way science is done from the way it was done 10 or 15 years ago."
According to Berg, material transfer agreements aren't limited to only corporate sponsors. "One of the worst offenders are universities themselves," he maintains.
"They often try to capitalize on their intellectual properties," says Berg. "Call someone at a university and ask for some material-a plasmid or a strain, for example-and you have to sign a three- or four-page document saying that you agree that anything you discover using this material is the property of the university sending it to you.
"Universities have finally realized that there are potentially lucrative payoffs from faculty discoveries," he notes, adding that Stanford helped set the university standard when it shared in a patent for recombinant DNA technology in 1980, which will have earned more than $150 million when it expires next year.
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"This is another important problem," says Sachs, who is also director of the Transplantation Biology Research Center at Massachusetts General Hospital. "Each company or university wants to write the rules about the rights."
The situation gets worse, he notes, when the agreements aren't straightforward and require substantive discussion among the company, the scientists, and the university's intellectual property office regarding publishing and patenting conditions. This could delay an experiment for months.
"Now almost every group you deal with has some sort of material transfer agreement. It used to be that you could just send something. Now everyone is protecting something," Sachs says, pointing to a "heightened awareness of potential patents and income" from research.
"Fortunately, most collaborations can still occur as long as there isn't any commercial involvement," he states. "We can still send and receive reagents." He adds that while "there's a major advantage to having commercial research funding in addition to federal money, I'd like to see it [industry collaboration] done in some way without these restrictions."
Though confidentiality agreements may sometimes frustrate researchers, industry officials comment that such situations are unavoidable: Companies want to protect their investments and certain information.
"We don't dictate to academic collaborators," says Millennium's Laurence Reid. He explains that most agreements are relatively straightforward. The university scientists present to Millennium the research they wish to publish, and the company has a certain agreed-upon period-usually 30 or 60 days-to review the data. "If there is information that can be protected by a patent, we go ahead and file. Then the researchers can publish.
"The academic may feel restricted in sharing with other academics, but it doesn't preclude publication in the long term."
Reid acknowledges that scientific research has become "more secretive in the last 20 years.
"Part of it is tighter funding. Part is the higher profile of some [potentially lucrative] science. But it's also more general competitiveness for positions at universities, and for promotions and grants."
Vogelzang of the University of Chicago sees the pharmaceutical and biotechnology industries as major supporters of institutional research that "have been completely open with institutions" with which they deal.
"While I have pet peeves about industry, in general, their ability to produce new compounds, their ability to fund cutting-edge research, and their willingness to share it with large numbers of investigators are all pluses. I don't think there's a problem with secrecy."
Vogelzang signs confidentiality agreements with pharmaceutical and biotechnology companies frequently. Yet such contracts hardly hinder his research, he believes.
"This isn't as widespread as you might imagine," Vogelzang asserts. "It is not a corrupting, subversive influence in the academic environment. If anything, it's speeding research. The amount of money that industry puts into research-you can't imagine the sort of ideas that are spun out of these new companies. They're trying hard to bring their ideas along. I don't think that being cheerleaders for their new products means they have to be on the Internet spelling out their formulas."
"As clinical scientists, we sign confidentiality agreements all the time," notes Allan Lipton, a professor of medicine and chief of oncology at Pennsylvania State University's Milton S. Hershey Medical Center in Hershey, Pa. Lipton, however, cannot recall when a company "didn't want me to talk about or publish clinical data. Usually they [companies] are open about it."
He acknowledges that some publications may be delayed slightly because of patenting issues. In his experience, most agreements stipulate that the collaborating or sponsoring company has a right to examine research results: "I personally haven't had the experience that Rosenberg has had."
University of Wisconsin cancer immunologist Paul Sondel considers confidentiality agreements an increasingly common-yet manageable-fact of academic research life.
"The agreements are drafted by the company, go to the investigator, and the university also has to sign off," explains Sondel, a professor in the departments of pediatrics, human oncology, and genetics at the University of Wisconsin Comprehensive Cancer Center. "The university also has strict guidelines regarding publishing scientific results. If I'm working with a company, and I want to publish results, the company has 60 days to review it. If they don't want something published, they have to explain why and it's up to us to ultimately determine whether we should or shouldn't.
"The university does not allow us to enter into an agreement that could completely gag publication of our results.
"I agree with what Rosenberg is saying... -if you're accepting [a 60-day delay in publishing results] then you're agreeing with the company you're collaborating with not to show data you generated," he says. "I need to talk to them and make sure it's okay with them for me to present it at a meeting. So in some ways it functions as a gag, and there is a little embarrassment. If others know about the work you're doing and want to know about an experiment you must have done-and you can't talk about it-it could be embarrassing."
Academic-industry collaborations often entail working with company scientists, Sondel notes, which minimizes disagreements about publication.
While some agreement discussions last months, he says, "most of the companies I've worked with have been able to work with our lawyers to come up with agreements both parties are comfortable with.
"So much of biological research involves reagents that might have been initially made in an academic institution which today isn't in a position to produce them. They have been licensed to a biotech company now. So more high-tech research today depends on reagents-antibodies, genes, and so on that are made by or made by processes licensed to biotech companies, which now makes us close collaborators of these companies and somewhat careful about what we present at meetings and making sure we get approved.
"From a pure science perspective, I'd rather be honest and open at meetings about any science we have, but because of these proprietary agreements I can't be."
Confidentiality agreements "clearly affect the way I do my job the way [they] didn't a dozen years ago," he adds.
Protecting Information "On balance, industry is fostering progress rather than impeding it," remarks Ronald Levy, who deals with confidentiality agreements almost daily. Levy, a professor of medicine and chief of the division of oncology at Stanford University School of Medicine, observes that "no one would be in the business of making these products unless they can own, protect, and profit from them. We have to find a way to keep all parties' interests addressed.
"If we have to tell companies what we're doing before we publish, that's okay. But we can't let them muzzle us or have veto power over what we can say.
"It's reasonable that companies have some confidentiality requirements," he points out. "Companies usually come in wanting everything secret. Scientists want total openness. We work it out."
At Amgen Inc., a biopharmaceutical firm in Thousand Oaks, Calif., for example, the company has 30 days to review a collaborating scientist's results prior to submitting the work for publication. Amgen looks for confidential company information that the firm provided or generated itself. The company also has 90 days to request a patent on any appropriate findings, which may delay publication.
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He sees the policy as pretty much standard and views Seragen as "fairly flexible" regarding its conditions of confidentiality and publication of research with its collaborators. Most academic scientists and university officials probably wouldn't sign an agreement they thought was too restrictive, he notes.
"We need to figure out a way to keep communication open to our colleagues about progress without ruining the chances of manufacturers profiting eventually," says Levy. "We have to let them see what we do and let them know what we're talking about in public so they can protect themselves."
He notes that he and his scientific colleagues often discuss these issues. "I'm not sure that anything has changed from 10 years ago. Perhaps what's changed is that there
are more companies to work with." He's not sure if the tightening budgets have necessarily affected the way science is done, however.
"We have to be careful that we don't let companies impede our freedom of information gathering and dissemination," he warns.
"Rosenberg has raised an important issue. We need a balanced discussion."