WASHINGTON — Pharmaceutical company officials admitted Thursday that the public's confidence has been eroded by the controversy over the firms' failure to publish unfavorable results from clinical trials of the safety and effectiveness of antidepressants for children.
They said they hoped that their recent commitments, individually and collectively, to make data from clinical trials of these and other drugs available would help restore the public's trust.
"We believe there is clearly a societal crisis in terms of credibility for drug companies," Dr. John R. Hayes of Eli Lilly & Co. told the House Energy and Commerce Committee.
Pharmaceutical Research and Manufacturers of America, a trade association representing most drug companies, announced Tuesday that as of Oct. 1, it would have a website -- 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 the information they needed 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 younger 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 popular antidepressants known as selective serotonin reuptake inhibitors failed to show that the drugs were effective in children.
When the committee began its investigation this year, only three of those studies had been published, according to the committee. Several have been made public since.
