Industry to publish drug data

Will release clinical trials, companies tell Congress

September 10, 2004|By LOS ANGELES TIMES

WASHINGTON - Pharmaceutical company officials admitted yesterday that public confidence has been eroded by the controversy over the industry's failure to publish unfavorable results from clinical trials of the safety and effectiveness of antidepressants for children.

They said they hoped that commitments, individually and collectively, to make data from clinical trials of these and other drugs available would help restore the public's trust.

Pharmaceutical Research and Manufacturers of America, a trade association representing most drug companies, announced Tuesday that as of Oct. 1, it would have a Web site - www.clinicalstudyresults.org - with access to all study results since October 2002 for drugs marketed in the United States.

Joseph S. Camardo, a senior vice president of Wyeth Research, told reporters during a break in the hearing that the media and congressional outcry over the link between antidepressants and suicide, along with the failure of drug companies to disclose results of their drug trials, "brought the issue to everyone's attention."

During the hearing before the House Energy and Commerce subcommittee on oversight and investigations, members of Congress also assailed the drug companies and the Food and Drug Administration for failing to provide doctors and parents with information they need to decide whether antidepressants would help or harm children.

Fluoxetine hydrochloride, marketed as Prozac, is the only antidepressant approved by the FDA for children.

But four other antidepressants were prescribed more frequently to children 17 and under between 1998 and 2002 - sertraline hydrochloride (Zoloft), paroxetine hydrochloride (Paxil), bupropion hydrochloride (Wellbutrin) and citalopram hydrobromide (Celexa), according to the FDA.

Twelve of 15 studies of the popular antidepressants, known as selective serotonin reuptake inhibitors, failed to show the drugs were effective in children.

When the committee began its investigation earlier this year, only three of those studies had been published, according to the committee. Several have been made public since.

An internal FDA study and a study done by Columbia University at the FDA's request both concluded that, according to the drug companies' own trials, children were almost twice as likely to have suicidal thoughts or behavior if they took the drugs than if they took placebos.

Committee members criticized the FDA for failing to cooperate with their investigation.

Rep. Joe L. Barton, a Texas Republican who is chairman of the subcommittee, read an e-mail from an FDA official directing his colleagues not to provide Congress with "draft documents, notes, memos to self or file or incoming contacts from non-FDA individuals."

But Dr. Janet Woodcock, FDA's deputy commissioner for operations, defended the agency, saying, "We have legal restrictions of the kind of information we can disclose."

Several committee members criticized the FDA for telling one of the companies, Wyeth, to remove information from the label of its antidepressant Effexor warning that, in clinical studies, patients ages 6 to 17 showed increased reports of suicidal behavior and hostility.

The Los Angeles Times is a Tribune Publishing newspaper.

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