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Paper Cuts

and archive the articles. In late October 2004, several publishers met with the NIH to argue against the plan. They said a delay longer than six months was needed in order for them to recoup their investment on an article. "Publishers say the U.S. would lose a valuable export since overseas buyers represent a significant slice of sales," reported the Wall Street Journal. Despite intensive lobbying by opponents, as of mid-December the NIH was moving forward with the plan and was expected to make a final decision in January of 2005.

But there is one matter on which research librarians, academicians, government officials, openaccess proponents, and journal editors are in agreement: the current cost of biomedical journals is too high and not in the best interests of medicine, science, or the public.

In a September 2002 report entitled "Scientific Publishing: Knowledge is Power," financial services giant Morgan Stanley estimated that science, technology, and medical (STM) publishing worldwide was a $7-billion industry, with U.S. academic libraries accounting for 60% of the market. The report, aimed at investors, focused specifically on Reed Elsevier (the parent company of Elsevier, the world's largest publisher of STM journals). "Market leader Reed should outperform the market . . . as libraries trim peripheral suppliers who can't bundle journals as effectively," predicted the report. Furthermore, "STM publishing accounts for 37% of Reed's profits and 40% of its cash flows."

But there is one matter on which there is agreement: the current cost of biomedical journals is too high and not in the best interests of medicine, science, or the public. In a 2002 report, financial services giant Morgan Stanley estimated that science, technology, and medical publishing worldwide was a $7-billion industry.

Research libraries spend more on Elsevier titles than on any other publisher's journals, according to an August 2004 report from the Association of Research Libraries. That report compared the average expenditures of research libraries on for-profit and nonprofit publishers in 2002. For-profit publishers were far more taxing on

libraries' budgets, with average expenditures per publisher ranging anywhere from two to 20 times more than per nonprofit publisher.

Given these figures, it's easy to vilify the for-profit companies, which include Blackwell; Elsevier; Kluwer; and Lippincott, Williams & Wilkins. Yet the true picture is more complex. In fact, the size and influence of these huge publishing houses provide some advantages for journal editors and the scientific community as a whole.

Earlier this year, when DMS's Jack Cronenwett and the Journal of Vascular Surgery (JVS) were threatened by a lawsuit from a biotechnology firm, Cronenwett experienced firsthand the benefits of having what he calls "the big kid on the block" behind you. In December of 2003, the JVS, which is published by Elsevier, received a scientific manuscript about a device used to treat aneurysms. The paper—written by four FDA scientists—concluded that the device might result in higher mortality rates than open-surgery procedures. The JVS reviewed the article and, in March, accepted it for publication. On May 7, the journal posted the copyedited and author-approved paper in the prepublication area of the JVS Web site. The manufacturer of the device, Medtronic, was not pleased. A September editorial in the JVS written by Cronenwett and his coeditor, James Seeger, M.D., recounts the events that followed:

"On May 20, 2004, the authors contacted the Journal to request that this accepted article be removed from the Journal Web site so that changes could be made prior to print publication. They related that Medtronic, Inc., had raised major concerns about the content of the article, which had prompted a rereview of this submission by the FDA Center for Devices and Radiologic Health, from which the article originated. Subsequently, on May 21, the Journal was contacted by an attorney at Medtronic, Inc., who alleged that the authors had used confidential and proprietary data to write the article without the permission of Medtronic. . . .

"On May 25, the editors and publisher received a 'request to cease and desist unauthorized publication of Medtronic, Inc.'s Confidential Data,' from the law firm King & Spaulding, LLP, representing Medtronic, Inc. This letter indicated that Medtronic, Inc., strongly objected to the publication of analyses of post-market approval study data, which had been submitted to the FDA by Medtronic under the confidentiality provisions of the Federal Food, Drug, and Cosmetic Act and the Freedom of Information Act. The letter also alleged that public release of such information would constitute both criminal and civil violations under these acts, and indicated that if the Journal chose to ignore this request, Medtronic would pursue all available legal remedies against the Journal and protect its interests in court if necessary."

Despite the fact that the data contained in the study had been posted since December 2003 on the FDA's own Web site, as a Public Health Notification, the agency insisted the article be pulled. Trying to find a way to get the paper to the public, Cronenwett and his coeditor worked closely with Elsevier's legal council.

"We were all hoping to find a legal way to publish the article," he says. "When it turned out that we couldn't, everyone was frustrated." In general, Elsevier will support its editors and provide legal assistance "for the sake of maintaining the credibility of the scientific process," he says. "And I think that is potentially an advantage. . . . Without some deep pocket in terms of opposing that type of legal action, it would be difficult for a journal to stand up to that."

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