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The Etiquette of Promoting Legal Professionals

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If this is where clinical research is headed, that would be a terrible negative trajectory,” he said. Dr. Topol – who drew attention last year with a finding that Celebrex and its competitor, Vioxx, appeared to raise the risk of heart attacks – said the Bextra studies did not include enough patients to justify drawing a broad conclusion. The average age of patients in the study, 23, did not represent the population likely to take the drug, he added. Yet through publication in the leading dental journal, the research helped Bextra’s marketers shift attention away from the F.D.A.’s negative findings. Because of confidentiality rules, the F.D.A. cannot release any information about the earlier pain studies that failed to sway regulators. ”Even though the study lacked some important proof, the real problem is that in the dental literature, this will be read,” Dr. Topol said. ”And dentists, who have to deal with trying to prevent or modulate pain, will be impressed.” Judy Glova, a spokeswoman for Pharmacia, said the drug company stood behind the design and conclusions of the Scirex studies. Pharmacia was not trying to bypass the regulatory process, she said, adding that the company is in discussions with regulators to have Bextra approved for acute pain. Scirex executives did not return repeated phone calls. Editors at The Journal of the American Dental Association said the Scirex article was reviewed by at least three scientists. One reviewer, Dr. Paul A. Moore, an associate editor of the journal, said the study was ”carefully designed and rigorously performed.” But Dr. Moore said he would have recommended that the journal reject the paper had he known that Bextra was not approved for acute pain. The Bextra episode is just one example of the changing face of drug research. In the early 1990’s, about 75 percent of the drug industry’s clinical research dollars went to universities, according to a study by CenterWatch, a company that tracks clinical trials. By 2000, just 34 percent went to academic institutions, while the rest went to investigators working under the direction of either a private research firm like Scirex or a pharmaceutical company. Omnicom says it has no control over Scirex. ”We have nothing to do with the design of clinical studies,” said Pat Sloan, an Omnicom spokeswoman. Yet when the ad agency paid $20 million for part-ownership of Scirex in 1999, a top Omnicom executive, Thomas L. Harrison, said he expected Scirex’s research to produce positive results for drug company clients – results that would help speed new-drug applications, or N.D.A.’s, to the F.D.A. ”Our goal,” he said, ”is to help ensure that all clinical studies and each patient accrued into a study can be assessed to support the N.D.A.

I kept having to put it down while my mind spun up ideas. In a few cases, you can subtract more then ten points for issues that provide grave areas of significant concern. This is definitely an issue where the merchant may have some responsibility, unless the default palette provided by the theme causes these issues to start with. 7, but start dropping points, as you get more uncomfortable with their professionalism. If on the other hand the TSCM expert does not mention his customers award 3 points, then ask for references, and then when he declines to provide references award three more points (or if they give you references subtract 6 points). Next, you want to aggressively pressure them for client names, and for references, and then if at this point (under pressure) they keep their mouth shut you add 6 points, or if they give in and breach their client privacy, you subtract 6 points.

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”The time it takes for a new technology to be adopted by 50 percent of US households has long been used by economic historians for cross-technology comparisons. We would like to help draft this manuscript,” Marcia Zabusky, a vice president of Intramed, told the doctors in a conference call, according to a transcript of the conversation obtained by The New York Times, ”and then submit it to you for your – for your editing and for approval.” During the call, Shane Schaffer, a Novartis marketing executive, told the doctors that the company wanted ”a quick, down and dirty” article. A study expected to provide scientific data showing Ritalin LA’s advantages was not scheduled to start until the following day, he said, but the lack of research findings should not be an obstacle. ”Obviously, we have to stick within data limits of what’s published currently as well as what we know are factual about these products,” he told the doctors. ”But, of course, inferences can be made.” One such ”potential theoretical conclusion” of the article, Ms. Zabusky added, was that a drug that worked for 9 hours might be better than a 12-hour drug. The doctors – John S. Markowitz and Kennerly S. Patrick of the Medical University of South Carolina – agreed to what Intramed and Novartis proposed. ”I think we’re quite clear on what you want the next manuscript to look like,” Dr. Patrick said as the call concluded. To produce the new draft, Intramed turned to Linda Logdberg, who has a doctorate in anatomy and has made her living the last 12 years as a ghostwriter for Intramed and other medical marketing companies. Starting with an outline approved by Intramed, Dr. Logdberg said that she produced a new manuscript in a few days. The assignment was one of her last ghostwriting tasks. Dr. Logdberg, who recently took a job teaching biology to high school students, said that she had become increasingly disenchanted with the process. Typically, she said, her manuscript would be sent to the drug company for approval before it was given to the doctors who were paid to be listed as the authors. Some doctors fretted over each comma, Dr. Logdberg said, while others made no changes at all. The marketing companies, she added, ”will drop a doctor if they don’t think he will be particularly malleable.” The result, Dr. Logdberg said, is marketing masquerading as science. ”What I mind is advertising that calls itself education.” The ad agencies’ medical education companies say that they neither toy with science nor ghostwrite articles that physicians use to make decisions about prescribing drugs. ”We make editorial suggestions,” said Jed A. Beitler, chairman of Sudler & Hennessey, a division at WPP that includes Intramed. ”The doctors are the ultimate writers.” Dr. Markowitz and Dr. Patrick agreed, saying that Intramed did not dictate what their paper should say. ”No figure, no table, anything goes in without our approval,” Dr. Markowitz said. Dr. Patrick added that he thought, based on past research, that a drug like Ritalin LA could be better for certain children than other long-lasting drugs. Neither the doctors nor the companies disputed the accuracy of the transcript of their conference call. Novartis said the article was not intended to conclude that one product was better than the others. Instead, the company said, it was a review of the available medications in which the authors could suggest theoretical advantages. Mr. Beitler said that Intramed was unhappy with the manuscript that Dr. Logdberg produced and later gave the assignment to another writer. The article has not been published. A 1998 survey of named authors writing for some of the nation’s top journals, including The Journal of the American Medical Association, which published the survey, found that 11 percent of the articles had been ghostwritten. Some experts think the practice continues to grow, even as the best journals take steps to prevent it. Wyeth hired ghostwriters in promoting the diet drug combination fen-phen, according to documents made public in litigation filed after it became evident that fen-phen caused a potentially deadly heart-valve defect. Evidence of ghostwriting has also surfaced in federal and state investigations of Warner-Lambert’s marketing of Neurontin, an epilepsy drug, for more than a dozen unapproved uses. If you enjoyed this short article and you would certainly such as to get more information relating to free article kindly browse through our site. One document made public in a whistle-blower lawsuit against Warner-Lambert describes how Proworx, a company owned by the ad giant Omnicom, offered to help write journal articles about using Neurontin to treat pain. Proworx planned to recruit doctors to be the named authors of the articles, paying them a $1,500 fee. Omnicom declined to comment on the matter. Dr. Relman, the former editor of The New England Journal of Medicine, said there was no place in medical education for ad agencies. ”We don’t get anywhere in medicine without objective data,” he said. ”That’s the coin of the realm.