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Stories from the 2 most recent issues of the Chronicle of Higher Education. http://www.chronicle.com I think it raises important issues about occupational health research... - Ralph From the June 4 issue: Boston U. Researcher Presses Ahead With Plans to Publish Cancer Study That IBM Wants to Stifle By GOLDIE BLUMENSTYK A JURY OF PEERS: Richard W. Clapp's study of cancer risks among semiconductor workers at IBM manufacturing plants never made it to a widely watched trial in which the corporation prevailed in February. But the study, which suggested that those workers were at greater risk of dying of cancer than average Americans were, may yet see the light of day in a medical journal, despite IBM's insistence that publication would violate a court order. In his study, Mr. Clapp, a professor of environmental health at Boston University, cross-referenced the company's death-benefit file with another IBM file that included employee work histories and job titles. From that process, he says, he was able to draw statistical conclusions. He says the analysis is similar to the one he used in studies of deaths of veterans from the Vietnam War, work that was published in peer-reviewed journals in 1988 and 1991. He submitted his new study for publication in a forthcoming special issue of the journal Clinics in Occupational and Environmental Medicine, about health dangers in the electronics and semiconductor industries. Four peer reviewers had read and approved Mr. Clapp's article, which he wrote with Rebecca A. Johnson, a colleague from a private consultancy. Then, in late March, as reported last month in the journal Science, Mr. Clapp withdrew his submission, having learned of a stern letter sent by IBM's lawyers to lawyers for plaintiffs who had sued the company. The IBM lawyers contended that the information that the professor had analyzed as a consultant to the plaintiffs -- data about employees whose families had sought death benefits from IBM -- was provided to him under confidential conditions, which prevent him from making that data, or any analysis of it, public. In addition to invoking confidentiality as a bar to publication of the study, the company has also denounced Mr. Clapp's paper as "guesswork." It is a "litigation-driven, biased analysis of an unscientific file of data," says Christopher Andrews, an IBM spokesman. Mr. Andrews says the files that Mr. Clapp analyzed included data on all IBM employees, not just those who worked in semiconductor manufacturing. The data identified where the employees lived at the time of their death, but nothing about where they might have worked throughout their lives, or the nature of their jobs. Mr. Clapp says his analysis is sound, and that IBM's charges are spurious. "The lawyers by no means directed what we were doing," he says. He also dismisses the company's claim of confidentiality. IBM's lawyers introduced his study into evidence during a deposition with him in August of last year, he says, and they questioned him about it. After that, he says, it was up to those lawyers to take action to keep the analysis private. If it was intended to be confidential, he says, "it should have been stamped as such" within a few weeks of the deposition. Mr. Clapp, who now has conferred with his own lawyer and another at Boston University, says he is convinced that he should publish his analysis, both because doing so is in the public interest and because, legally, he argues, IBM no longer has the right to keep it confidential. He told The Chronicle that he will proceed with his attempt to have the study published, despite written warnings from IBM's lawyers that doing so would violate a court order. "I'm going ahead," he says. IBM faces about 200 lawsuits filed by current and former workers and their families, who contend that the company has concealed information about cancer-causing toxic chemicals used in the plants. The case for which Mr. Clapp was hired was brought by two former employees from IBM's manufacturing plant in San Jose, Calif. In February, after a four-month trial, a jury found that IBM was not liable for their cancers. Mr. Clapp's study was excluded from that trial. The judge, agreeing with IBM, determined that the analysis did not specifically identify chemicals to which the plaintiffs might have been exposed, and so was not relevant to the case. IBM officials maintain that Mr. Clapp's study is not relevant at all. The company spokesman, Mr. Andrews, points instead to another study, now nearing conclusion, by Elizabeth Delzell, a professor of epidemiology at the University of Alabama at Birmingham. That study, being conducted with IBM's cooperation and $4.4-million in support from the company, is a "retrospective mortality and cancer-incidence study" of employes at three manufacturing plants: Burlington, Vt.; East Fishkill, N.Y.; and San Jose. IBM commissioned the study in 1999. Both IBM and Alabama rejected a reporter's request to review the sponsored-research agreement for information on the methodology being used or what, if any, publication restrictions might exist. Ms. Delzell declines to discuss the work, except to say that the contract with IBM "guarantees that we have complete control over what we study." Mr. Andrews says IBM expects the study to be completed by the end of this year. "We're going to stand by it," he says. Those who made the decision to publish Mr. Clapp's study also stand behind their man. Joseph LaDou, guest editor of the special issue of Clinics in Occupational and Environmental Medicine and director of the International Center for Occupational Medicine at the University of California at San Francisco, says he understands that the study has some shortcomings. But he is eager to publish it nonetheless. "It's the most definitive cancer study to date, despite its limitations, and for that reason it should be before the scientific community," he says. The special issue of the journal is due out in November. http://chronicle.com Section: Research & Publishing Volume 50, Issue 39, Page A15 Copyright © 2004 by The Chronicle of Higher Education Thursday, June 10, 2004: Elsevier Rejects Disputed Study on IBM Workers, but Authors May Pursue Other Publishing Options By GOLDIE BLUMENSTYK Elsevier rejects disputed study on IBM workers, but authors may pursue other publishing options Cuban government orders study group from American college to leave Another women's institution, Lesley College of Massachusetts, chooses to go coed Nationwide strike and violence shut down higher education in Nepal Under peace accord in Sudan, 3 universities will move back to rebel-held region A leading publisher of scholarly journals has rejected a controversial study by a Boston University professor and a colleague that had already passed the peer-review process. The article suggests that workers at IBM semiconductor plants were at a higher risk of dying of cancer than the population as a whole. The publishing company, Elsevier, said its decision was not based on concerns about legal retribution by IBM, which maintains that the authors do not have a right to publish the article. Rather, Elsevier said that its journal, Clinics in Occupational and Environmental Medicine, publishes "only review articles," not original research, which it says can be found in the article. IBM has denounced the study as flawed and contends that the authors, Richard W. Clapp and Rebecca A. Johnson, are bound by a court order barring them from publishing the study because it is based on data that were provided as part of a court case under conditions of confidentiality. Mr. Clapp maintains that the confidentiality restrictions no longer apply (The Chronicle, June 4). Mr. Clapp is a professor of environmental health at Boston University. Ms. Johnson is a private consultant who helped Mr. Clapp with computer analysis of the data. The rejection from Elsevier came in an e-mail message from Catherine Bewick, the company executive who oversees the journal and others in Elsevier's Medical Clinics of North America series. The message was sent to Joseph LaDou, guest editor for a forthcoming special issue on the semiconductor industry. Ms. Bewick did not return telephone calls or respond to e-mail messages seeking comment. Her office said she would be out all week for personal reasons. Elsevier's director of corporate communications, Eric Merkel-Sobotta, said on Wednesday that "the article was rejected by a guest editor because it was in the wrong format." Dr. LaDou, who is director of the International Center for Occupational Medicine at the University of California at San Francisco, said that characterization was "totally untrue." "I've never said anything of the kind," he said. Dr. LaDou said it appeared that Elsevier was "taking the easy way out." He said he does not consider the article to be original research but an analysis of IBM's data, "to the extent that they were willing to share it." He has been eager to publish the study, which he considers important despite its limitations. He acknowledged that the work is not technically a "review" article because it does not distill information from previously published studies. Dr. LaDou said seven of the nine other authors whose articles are scheduled to appear in the special issue of Clinics have told him that they would be willing to withhold their articles -- a sort of boycott -- unless the study by Mr. Clapp and Ms. Johnson were published in that journal or in some other appropriate journal. As an alternative, Dr. LaDou had hoped to be able to publish the article in a forthcoming special issue of the Journal of Occupational and Environmental Medicine, of which he is also a guest editor. It is scheduled to appear at about the same time as the Clinics special issue, in November. Dr. LaDou had tried to get the article approved based on its prior peer review. But on Wednesday that plan fell apart. The editor in chief of the Journal of Occupational and Environmental Medicine, Paul Brandt-Rauf, said that while he was not concerned about the legal issues related to IBM, he would still want to submit the article to peer review, or examine the comments of the prior peer-reviewers, before accepting it. That could take several months. Articles in that journal, which is published by the American College of Occupational and Environmental Medicine, often include original research. Mr. Clapp could not be reached for comment on Wednesday, but he has previously indicated that he might also pursue publishing options with two other journals that have also expressed interest in the study. One of them is an online journal. Since online journals often have shorter turnaround times for reviewing articles, Dr. LaDou said that if Mr. Clapp decided to go that route, he would refrain from pursuing the boycott of the Elsevier special issue until it became known whether the online journal would publish the Clapp-Johnson study. Copyright © 2004 by The Chronicle of Higher Education
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