This is the second editor from the NEJM to call for increased transparency from drug companies WRT research/studies (A former editor did the same last year, IIRC.)
[This website is based in the 'Research Triangle' of NC.] http://www.wral.com/aphealthandwellnewsnews/4521886/detail.html "Pfizer Inc., GlaxoSmithKline PLC. and Merck & Co. are "making a mockery" of efforts to create more transparency in drug clinical trials, according to a prominent medical journal editor. "Dr. Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine, said the companies are not providing enough useful details in their posting on a government trial registry and that their reluctance to provide meaningful information may hamper their ability to have their studies published in important medical publications... "...Drazen based his comments on a review of the information drug companies posted on www.clinicaltrials.gov., which is run by the U.S. National Institutes of Health. He said the review was conducted by Dr. Deborah Zarin of the NIH at the request of the committee. "They (the three companies) are giving nonsense details," Drazen said in an interview on Monday. "They are written in a way that they are trying to hide what they are doing." "...The editors created the policy after some drug companies were accused of stifling negative data from clinical trials... "...Zarin said first she looked at whether pharmaceutical companies were giving drugs a distinguishable name. She said a name is crucial because it allows editors, patients and doctors to track a medicine's progress through the trial process.. "...Of the over 400 companies with trials listed on the registry, only 5 neglected to list specific names, often calling the products simply "investigational drug", Zarin said. "Zarin said that 90 percent of the time Merck didn't provide a name. Glaxo didn't provide a name 53 percent of the time while Pfizer lacked a name 36 percent of the time. The other two companies were Eli Lilly & Co. and Bristol-Myers Squibb Co. but they lacked names less than 5 percent of the time... "...Drazen said that Lilly and Abbott Laboratories are "90 percent in compliance" with what the editors are expecting. Zarin gave high marks to Novartis for the quality of its disclosures... "...Drazen said that if the companies don't comply, editors will refuse to publish their studies. He said that other medical journals had adopted the registry standards of the international committee so companies that don't comply may find their choice of publication venues is limited..." Article from Businessweek (not as detailed): http://www.businessweek.com/ap/financialnews/D8A95F601.htm?campaign_id=apn_home_down >From last fall: http://www.chronicle.duke.edu/vnews/display.v/ART/2004/09/13/41457eb5b032f "Eleven of the world’s top medical journals are making the reporting of all clinical trial results a condition of publication in an attempt to remedy concerns about the selective disclosure of experimental data by pharmaceutical companies. The members of the International Council of Medical Journal Editors announced Wednesday that they would publish reports only if the results of those trials are registered in an online database, www.clinical trials.gov, which is run by the National Library of Medicine. This proposition has received much federal support and members of Congress intend to introduce legislation in the near future that will prevent pharmaceutical companies from withholding unfavorable information about their products... "...Academics also agree on the pressing need for increased transparency in the pharmaceutical world. “We only know what works, but what doesn’t work is just as important,” said Elizabeth Vigdor, assistant professor of public policy. “Only printing what the pharmaceutical companies want creates a publication bias and we should put research into perspective.” "Pharmaceutical companies, including Eli Lilly, Forest Laboratories, GlaxoSmithKline and Merck, have reacted strongly and have offered counter-proposals such as optional registration, but Curfman and the other editors will not accept such propositions... "...“It is difficult for people to understand the true complexity of these data sets—we want fair presentation but in a journal only a very small data sample is scrutinized and published,” he [David Pisetsky, editor of Arthritis & Rheumatism] said. “It requires an extraordinary time commitment to look at these data sets and protocols, which is only possible for large medical journals like the Journal of the American Medical Association, the New England Journal of Medicine and The Lancet—three of the big supporters of this decision.” "Smaller journals, including Pisetsky’s, rely on volunteer reviewers and do not have a full-time staff. “It will be very difficult to get people to analyze all this highly sophisticated data that would now be required,” he said. “I just don’t think this is necessarily the best way to accomplish this.” "Pisetsky, on the other hand, does agree with the other editors that the FDA needs to strengthen and expand its expertise in monitoring clinical trials. “It is not the journal’s responsibility to be a regulatory agent. The FDA has already established itself as the primary investigator of drug tests and it should stay that way,” he said." Debbi The Good, The Bad And The Medicated Maru __________________________________________________ Do You Yahoo!? Tired of spam? Yahoo! Mail has the best spam protection around http://mail.yahoo.com _______________________________________________ http://www.mccmedia.com/mailman/listinfo/brin-l
