Drug Firms launch Web Site to disclose Trials Data

posted on:
September 21, 2005

author:
Staff

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 favorable conclusions.

The new portal (www.ifpma.org/clinicaltrials), established by the International Federation of Pharmaceutical Manufacturers and Associations, links available on-line information about clinical trials worldwide.

Plans for the portal were first announced earlier this year.

Drug makers—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, Richard Barker, director general of Britain’s pharmaceutical association, 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.

The new Web site plan has the backing of major pharmaceutical groups such as GlaxoSmithKline Plc , Pfizer Inc. , AstraZeneca Plc , Merck & Co. Inc. , Novartis AG and Sanofi-Aventis SA .

Controversy about drug companies concealing 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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