New York Attorney General Eliot Spitzer and
on Thursday announced a settlement in which the U.K.-based drugmaker agreed to release previously unpublished data about the safety and effectiveness of the antidepressant drug Paxil.
The settlement comes after Spitzer sued the company in June, alleging that since 1998 it had committed "repeated and persistent fraud" by "concealing and failing to disclose" information to doctors about Paxil's impact on children.
The company said that although the charges in Spitzer's suit "are unfounded," it had agreed to pay the state $2.5 million "to avoid the high costs and time required to defend itself in protracted litigation."
Paxil hasn't been approved by the Food and Drug Administration for children, and this prevents the company from marketing the drug as a treatment for them. Federal law, however, does allow doctors to prescribe the drug for children. What is called "off-label use" practice applies to any drug approved by the FDA.
The agency has been investigating the prescribing of antidepressants by doctors to youngsters, and an FDA advisory committee will conduct two days of hearings about antidepressants and children next month.
One key issue is determining whether antidepressants increase the risk of suicidal thinking and/or behavior among adolescents and children for whom these drugs are prescribed. The FDA issued health advisories in March 2004, October 2003 and June 2003 concerning children and antidepressants. After reviewing reports on 10 drugs, including Paxil, the agency said earlier this year that "it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior."
A new study commissioned by the FDA and conducted by Columbia University in New York, however, presents results that are "suggestive of an increased risk of suicidality for some of these
antidepressant drugs," the FDA said last week in announcing the advisory committee meeting.
The agency didn't identify the drugs. It also noted that "there remain inconsistencies in the results, both across trials for individual drugs and across drugs." Evaluating this data "represents a substantial challenge," the FDA said.
Meanwhile, the agency has asked drugmakers to change their drugs' labels to include "stronger cautions and warnings" about the need to monitor patients whose depression worsens or who talk about suicide. Among antidepressants, only Prozac is approved for children and adolescents for a condition called pediatric major depressive disorder. Zoloft and Prozac have been approved by the agency for treating obsessive-compulsive disorders in children.
Spitzer had accused GlaxoSmithKline of failing to disclose information about what he said were four negative tests on Paxil's effects on children and adolescents. The company, he argued, only released information on one test that showed mixed results. The unpublicized tests "suggested a possible increased risk of suicidal thinking and acts in certain individuals," Spitzer said Thursday.
"This settlement holds GlaxoSmithKline to a new standard of disclosure about studies concerning its drugs," Spitzer said. "By agreeing to release both positive and negative studies about the safety and efficacy of its drugs, GlaxoSmithKline has set an example for the entire pharmaceutical industry."
In its statement, GlaxoSmithKline noted that on June 10 it "voluntarily posted" on its corporate Web site "full study reports" of all company-sponsored tests of Paxil being given to children and adolescents. The company said it was acting "in response to public concern about the access of
Paxil data in children and adolescents with depression." The company also said that on June 18 it had announced plans "that had been under way for some months" to create a clinical trial register that would provide Internet access to clinical trial data on its marketed products.
Spitzer's office said that under the settlement, the drug company will continue to post on a Web site the results of clinical studies regarding Paxil and adolescents and children.
"We are pleased that the attorney general believes the clinical trial register we have been developing will provide useful information to the medical and scientific community," said Mark Werner, GSK's senior vice president for U.S. legal operations.