“Hearings on Antidepressants and Children Lauded by Paxil Trial Counsel Jim Fitzgerald”

PRNewswire - September 7, 2004

2001 Verdict Leads to Congressional Hearings

CHEYENNE, Wyo., Sept. 7 /PRNewswire/ -- The United States House of Representatives' Congressional Oversight and Investigation Committee will hold a Hearing on "Antidepressants and Children" on Thursday, September 9th in Washington, D.C.

The time-tested mantra of "What did they know and when did they know it" will be one theme of the hearing. Citizens and some legislators will likely criticize drug companies for refusing to publish unfavorable clinical trial results. The Committee will investigate what the Food and Drug Administration and pharmaceutical makers knew about the safety of antidepressants before the drug industry began issuing warnings about the effects of drugs like Paxil earlier this year.

A study found that children and teenagers placed on antidepressants were more likely to think suicidal thoughts than those given fake pills without any actual medication. That study promptly focused attention on the issues of SSRI safety, warnings and studies.

Dr. Peter Honig, one of Merck's Senior Vice Presidents (Merck has no antidepressant on the market) has acknowledged the drug industry's growing image problem. It is expected that, more than image, the hearings will focus on the need for more historic information about the risks of drugs like GlaxoSmithKline's Paxil, side effects, and suicide.

Thursday's hearing was scheduled for July 20, 2004, but was postponed at the last minute. As it turns out, the hearing's timing may result in fuller questioning and more public information about Paxil side effects. In the past few months, even more researchers, doctors and medical journals have criticized drug makers over their choices of which clinical trials to publish and not to publish.

Facing accusations earlier this year, Glaxo agreed to post more data on its Web site. Still, some in Congress would require full public postings. GlaxoSmithKline will publish a database including all tests on drugs sold by the company, but the database will be limited to tests conducted since 2000, the year Glaxo Wellcome merged with SmithKline Beecham. Glaxo has said that the database would also contain results of earlier tests that the company deems medically significant.

Even though Glaxo has said that its database would also contain such results, a pending issue is whether drug companies should be able to choose which historical studies to publish.

A 2001 trial in Cheyenne, Wyoming, sparked media interest and re-awakened public concern over the adequacy of Paxil
warnings. A man in late middle age was prescribed Paxil. Soon thereafter, he shot and killed his granddaughter, his daughter, his wife of many years, and then turned his gunfire on himself.

The jury verdict states "by a preponderance of the evidence, that Paxil was a proximate cause of the homicides and suicide involved in this litigation."

One of the trial counsel, Jim Fitzgerald of Cheyenne, has stated that Paxil, sometimes in sample form, has continued to be dispensed by physicians and non-M.D. assistants, without adequate information about Paxil side effects or cautions to patients and their loved ones.

Following the September 9th hearings, the FDA will hold two more days of hearings on September 13-14. The later hearings will be held at the Holiday Inn in Bethesda, Maryland.

The hearings will include a presentation of the Columbia University Report on Children & SSRIs. This recent review revealed "a statistically significant association of suicidal events with antidepressant drug treatment in short- term pediatric clinical trials for all indications," according to Dr. Andrew Mosholder, a medical reviewer for the FDA.