DCF, Glaxo To Discuss Paxil BanAug 25, 2003 | Hartford Courant The British company that makes the antidepressant Paxil is sending its regional medical director to Connecticut this week to discuss the state's six-month ban of the drug for children in its care.
The Department of Children and Families in July was the first public child-protection agency to ban Paxil after the U.S. Food and Drug Administration recommended that it not be given to anyone under 18.
The FDA's move caught the attention of officials at Paxil manufacturer GlaxoSmithKline, which also promised to send a medical team to a meeting of the DCF committee that instituted the ban, according to Dr. Patricia K. Leebens, chairwoman of the DCF committee.
Leebens said the Psychotropic Medication Advisory Committee had no choice because of the FDA's "unprecedented" action and Glaxo-SmithKline's seeming unwillingness to publish studies on the drug's effects on children.
The company has funded nine studies on the issue but only one has been published. British regulators who first banned the drug last April and the FDA have seen all the study results. Even without specific FDA approval for use in children, Paxil is approved for general use and doctors have been free to prescribe it to any of their patients.
The company's reluctance to publish the studies got the attention of DCF committee members. The 20-member panel is made up of child psychiatrists, pediatricians, nurses and one patient advocate.
"Usually, companies put their scientific results out to the scientific community for scrutiny and Glaxo didn't do that in this case," Leebens said. "If they were benign studies, why weren't they published?"
The lack of published data left the committee in a quandary.
"The scientific information was terribly inadequate, yet we had a major regulatory body warning not to give out this drug to children," Leebens said.
The little information that had trickled out about the Glaxo studies was not promising.
Glaxo officials have said the nine studies looked at more than 1,000 patients under 18. In total, they showed that 3.4 percent of the children who were taking Paxil, or had recently stopped, attempted suicide or thought more about it. That compared with 1.2 percent of the children taking a placebo.
DCF officials would not say how many of the nearly 8,000 children in their care were on Paxil or other Selective Serotonin Reuptake Inhibitors, known as SSRIs, such as Prozac and Zoloft, made by Pfizer Inc. of Groton. Leebens did say that Paxil is the drug of choice for psychiatrists who treat adolescents because it has fewer side effects.
The committee has a mechanism for doctors or caregivers to file reports if a drug has an adverse effect on a DCF patient. Leebens said no reports of problems with Paxil have come before the committee.
Leebens has made it clear that if GlaxoSmithKline officials are not willing to discuss the company's unpublished results with the committee, it makes no sense for them to come to Connecticut this fall.
Experts say it's not surprising that Glaxo is reaching out to Connecticut officials.
Paxil had more than $3.25 billion in sales last year, $2.12 billion in the United States, and it is one of the company's biggest financial successes.
But Dr. David Healy, a psychiatrist and well-known SSRI critic who has served as an expert witness in several U.S. court cases against GlaxoSmithKline, said the drug companies have carved up the adult market for the SSRIs and are looking for new avenues for profits.
Children are the logical area for expansion, Healy said, especially because little research has been done on the effects of SSRIs on adolescents.