~~~ doing a websearch and just found this. never knew it was published before. ~~~

Corporate Collaborations

Author: Ilena Rosenthal

Date: July 19, 1999

Kudos for exposing the power of industry to make a mockery of true science.1 "He who hath the gold, makes the rules" has no place in the realm of science. Breast implant science is 30 years behind itself because of unfavorable studies such as those described in this phenomenal exposé, which were hidden. To date, doctors still describe silicone as being safe and inert and state that it doesn't migrate throughout the body.

Let's keep examining these and other serious conflicts of interest.

Ilena Rosenthal

Director, Humantics Foundation for Women

Breast Implants: Recovery & Discovery

San Diego, CA

References

1.P. Gwynne, "Corporate collaborations: scientists can face publishing constraints," The Scientist, 13[11]:1, May 24, 1999.

Volume 13, #11 The Scientist May 24, 1999

Corporate Collaborations

Scientists Can Face

Publishing Constraint

Author: Peter Gwynn

Date: May 24, 1999

Confidentiality agreements. Threats of lawsuits. Last-minute withdrawals of scientific papers. Sudden dismissals. Gag orders. Conflicts of interest, actual and potential. Lack of support for embattled faculty members by university administrators. It's a tough world for life scientists in the modern academic laboratory. Largely as a result of expanding commercial interest in academic research, today's faculty members and postdocs face threats and choices unknown to their predecessors.

The potential dangers of academic-industrial links formed one focus of a recent colloquium at the Massachusetts Institute of Technology, titled "Secrecy in Science" and sponsored by the American Association for the Advancement of Science and M.I.T. Speakers at the event highlighted two specific types of pressure: corporate objections to publication of research that might put individual companies in a bad light the effect of industrial support on academic scientists' attitudes toward such issues.

Speakers outlined three major instances of corporate pressure on life scientists to delay or cancel publication of research results. The best known is the case of David Kern, director of the Brown University Program in Occupational Medicine and the Occupational and Environmental Health Service at Memorial Hospital in Pawtucket, R.I. In December 1994, as part of his educational mission, Kern said that he and some of his students visited Microfibers Inc., a local fabric manufacturer. Everyone in the group signed a standard "agreement of secrecy and confidentiality," which required them not to reveal trade secrets. More than a year later, two workers at the plant under the age of 40 had been referred to Kern with symptomatic interstitial lung disease (ILD)--a condition very rare in young men. Shortly after that, Microfibers and Memorial Hospital reached an understanding that would permit Kern to investigate the apparent outbreak.

Eventually, Kern's group identified several cases of ILD at the Rhode Island location and another plant that Microfibers owned in Canada. But when he announced that he would present his findings at a conference of the American Thoracic Society, the company objected. It threatened legal action against him and Memorial Hospital if he published. Kern went ahead. But the hospital then fired him as director of its occupational health clinic, forbade him to treat Microfibers' employees, and said that it would not renew his contract, which ends this summer. The stated reason for the lawsuit threatened by Microfibers: the agreement signed before the site visit--an agreement, said Kern, that had nothing to do with his investigation. "I have never signed a nondisclosure agreement relevant to the study," he told the colloquium.

Drummond Rennie, adjunct professor of medicine at the University of California, cited two examples of researchers who had signed nondisclosure forms, and had come to regret it. Nancy Olivieri, an authority in blood diseases at Toronto's Hospital for Sick Children, signed an agreement with Toronto pharmaceutical company Apotex Inc. for a clinical study of deferiprone, a drug that the company had developed to treat the genetic blood disorder thalassemia. The study revealed that deferiprone was frequently ineffective, and even toxic.

When Olivieri informed patients about the finding, and published in the New England Journal of Medicine, Apotex threatened to sue her, citing the nondisclosure agreement. The hospital fired her as director of its blood disorders clinic. It also issued gag orders to prevent her colleagues from discussing the case. Authorities at the University of Toronto, where she was a faculty member, originally backed that action. At the time, the university was discussing a gift of $20 million from Apotex for a new medical building. It took the intervention of the University of Toronto faculty association to create a settlement that reinstated Olivieri and indemnified her legal costs.

An older case referred to by Rennie caused less grief to its chief protagonist, but did delay publication of significant information. A study of four thyroid hormones by Betty Dong, professor of clinical pharmacology at the University of California, San Francisco, showed that the market leader, manufactured by Boots Pharmacy (now known as Knoll Pharmaceuticals) was no more effective than the others. Dong prepared a paper on her results. But the threat of legal action by Boots forced her to withdraw it at the last minute. "We had a contract that did not allow us to publish without their permission," Dong recalled. She did finally publish, but not until two years had passed. By then, a scientific group associated with Boots had published its own article on the study, which analyzed the data in a way different from Dong's approach.

Implications for the Research Enterprise

What do those incidents imply for the research enterprise? A great deal, Rennie told the colloquium, because "science effectively doesn't exist until it's published." There is a tendency to publish only studies that favor new treatments, he pointed out. That puts physicians in the position of prescribing drugs based on false information.

Rennie sees some hopeful signs. Pharmaceutical company Glaxo Wellcome, for example, has agreed to publish the results of every clinical trial of its new drugs. "If other companies follow that example," he told The Scientist, "people will be able to track down the results of all trials."

In the meantime, how should researchers deal with research sponsors who have not made such a pledge? "It is obvious that, if neither Betty Dong nor Nancy Olivieri had signed their nondisclosure clauses, their universities would have been on very much stronger ground to back them up. So scientists must ensure that they never, ever, sign clauses like that," asserted Rennie. "If you're a university scientist, you serve the public. You have to disseminate; it's your duty to publish. The immediate lesson for scientists is never to sign. For universities, it is to have the backbone to back up their scientists. And one of the lessons for drug companies is that adverse publicity [over interference with publication] is appalling."

Rennie believes that a tough stand by universities will force pharmaceutical companies to back off. If university administrators say that academic freedom is far more important than research projects from drug companies, "the companies wouldn't go away," he argued. "They need the brains. They need the very brightest people, as they might form relationships with them in the future."

Invisible Influences

Delays in publication represent an obvious obstacle to the academic freedom of life scientists. However, researchers can and do experience other, more subtle, commercial pressures. Alan Hartford, a clinical and research fellow at the Massachusetts General Hospital, reported on a study of those invisible influences on academics in biomedicine.

In collaboration with David Blumenthal of the University of Minnesota, Hartford surveyed about 2,000 life science researchers; about two-thirds of the sample had some relationship with industry. "The survey found that scientists' attitudes reflected their involvement with industry," Hartford reported. Significantly, the individual scientists' "perception of industry's importance to the continuation of their careers had more effect on scientists' attitudes than the amount of money they received."

The study revealed more than perceptions about industry. According to Hartford, "20 percent of the sample reported not publishing or delaying publication for at least six months. Again, the key factor was the importance of the decision to the scientist's career." A factor relevant to decision-making about publication that emerged from the survey was the potential for application of the research results. However, said Hartford, "this is not as self-serving as it might appear. Researchers see an institutional factor, in which universities increasingly rely on industrial findings."

Implications for Universities

Universities certainly stand to benefit immensely from industrial interest in their research capabilities. With the fall of the Berlin Wall in 1989, said Lita Nelsen, director of M.I.T.'s technology licensing office, a lot of research universities started to look to industry to compensate for what they expected would be a catastrophic drop in federally funded research for military ends. Indeed, the proportion of industry-funded R&D at M.I.T. has risen from less than 6 percent 10 years ago to about 25 percent today.

Nevertheless, M.I.T. has resisted the urge to kowtow to industry. "A few years ago," said Nelsen, "M.I.T. administrators were berated for refusing to delay publication beyond 30 days (or 60 days in some cases), as well as insisting on no censorship, no reduction of overhead, and no use of students [for industry-funded projects]. But we held the line, and our industry support is now over $80 million and climbing. We explained to industry: 'You want us because we're different. We're not like you.'"

According to Nelsen, the major research universities are generally holding the line against industrial demands that might prejudice academic freedom. However, she fears that lesser universities might not resist the temptation so easily. "The threat to go elsewhere is very strong," she said. Rennie shares that concern. "I fear a race to the ethical bottom," he warned. "I find shocking the ambiguous behavior of fellow scientists."

Nelsen's prescription for preventing researchers from falling into ethical quagmires resembles Rennie's. "Administrators must prevent individual investigators from signing secrecy agreements," she declared. "They must protect faculty from themselves."

Peter Gwynne (pgwynne767@aol.com) is a freelance science writer based in Marstons Mills, Mass.

(The Scientist, Vol:13, #11, p. 1, May 24, 1999) (Copyright © The

Scientist, Inc.)