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Drug firms launch Web site to disclose trials data
 
 
  By Ben Hirschler
 
LONDON (Reuters, Sept 21, 2005) - The global pharmaceutical industry launched a new Web site on Wednesday giving details of clinical trials on new medicines in a bid to allay patient fears over drug safety.
 
The move follows criticism that companies manipulate or suppress results of clinical studies in order to come up with favourable conclusions.
 
The new portal (www.ifpma.org/clinicaltrials), established by the International Federation of Pharmaceutical Manufacturers and Associations, links available online information about clinical trials worldwide.
 
Plans for the portal were first announced earlier this year.
 
Drugmakers - some of which have already voluntarily launched their own databases - hope the project will head off legislation from governments in the wake of scandals over pain drug Vioxx and the use of antidepressants in adolescents.
 
The site will carry detailed information about most new clinical trials, but companies have the option to withhold some information.
 
Early-stage phase I studies on healthy volunteers -- often the first sign a company has a good hunch about a new drug approach - are exempt, and there is no obligation to reveal the results of studies before a drug is approved.
 
The voluntary scheme says that results should be published within one year of a medicine's approval or, for trials on drugs that have already been approved, within one year of the trial being completed.
 
Nonetheless, industry leaders said the new site was a significant step forward in transparency, allowing doctors and patients to carry out searches in particular areas quickly and easily.
 
Daniel Vasella, chairman and chief executive of Novartis AG and president of the federation, acknowledged that finding this data had been difficult in the past and said the site might give patients more options.
 
"It will allow patients, for example, to apply to enter into clinical trials or to wait for relevant data," he told reporters in a Webcast.
 
The new Web site, which was developed in conjunction with IBM, has the backing of other major pharmaceutical groups such as GlaxoSmithKline Plc , Pfizer Inc. , AstraZeneca Plc , Merck & Co. Inc. and Sanofi-Aventis SA .
 
Controversy that drug companies conceal research, either to prevent rivals from learning too much or because negative results would hit product sales, has been simmering for years.
 
But the issue came to a head last year with the worldwide withdrawal of Merck's Vioxx and accusations by New York Attorney General Eliot Spitzer that Glaxo fraudulently suppressed information about the use of its antidepressant Paxil, or Seroxat, in children. Glaxo settled the case for $2.5 million.
 
 
 
 
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