The FDA approves drugs for use based upon whether or not they are safe and effective, as determined through scientifically conducted clinical studies. Drugs are approved for specific conditions and for specific populations. The FDA has approved Paxil as safe and effective in treating various conditions and adults, but not for any illness or condition in children. Physicians may prescribe a drug for conditions for which FDA approval has not been obtained when, in the physician’s professional judgment, it is an appropriate treatment for the individual patient as long as the drug has already been approved by the FDA for some other use. This type of use is referred to as “off-label” use. A physician's judgment is based on the balance between the benefit the patient is likely to derive from the treatment and the risk that the proposed treatment will cause the patient harm. In deciding whether to prescribe a drug for an off-label use, physicians typically rely upon information received from other sources-- if information is false or misleading, a physician cannot accurately assess the crucial risk-benefit balance for use of the treatment.

The action alleges that SmithKline conducted three scientific studies to assess the safety and efficacy of Paxil in treating children and adolescents diagnosed with Major Depressive Disorder. It received the final reports for two of the studies in November 1998 and the third on July 31, 2001. The clinical trials met with mixed success at best-- the report on Study 329 (issue date November 24, 1998) concluded that, of two primary and five secondary measures of efficacy, Paxil was superior to a placebo only in three of the five secondary measures. Study 377 (issue date November 19, 1998) concluded, "the results failed to show any superiority for paroxetine over placebo in the treatment of adolescent depression." In Study 701 (issue date July 30, 2001), the placebo actually outperformed paroxetine in treatment of adolescent depression. The studies also showed a numerically increased rate of adverse events, including increased suicidal ideation and increased hostility as compared to placebo, when prescribed for adolescents and children.

Internal SmithKline documents allegedly point to a cover-up "to effectively manage the dissemination of these data in order to minimize any potential negative commercial impact." Thereafter, in accordance with the recommended plan, only the positive data from study 329 was presented-- neither study 377 nor study 701 was ever published, and remained unavailable to the general public until being posted on the GlaxoSmithKline website early in the summer of 2004.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK commented in a warning issued on June 10, 2003, on the questionable safety of paroxetine: it "should not be used in children and adolescents under the age of 18 years to treat depressive illness." That agency has also added pediatric status as a contraindication on paroxetine labeling in the UK. In response to the MHRA’s warning, GlaxoSmithKline admitted in a letter to physicians in the UK that the "clinical trials in children and adolescents under 18 years of age failed to demonstrate efficacy in Major Depressive Disorder, and that there was a doubling of the rate of reporting of adverse events in the paroxetine group compared with placebo, including emotional liability." On June 19, 2003, the US FDA issued a Talk Paper stating that it was reviewing data from studies of paroxetine use in children and adolescents with depression to assess a possible increased risk of suicidal thinking and attempts. The FDA now recommends "that Paxil not be used in children and adolescents for the treatment of MDD."

Despite its 2003 admissions to regulatory agencies and to the public in other countries, GlaxoSmithKline has allegedly continued to misrepresent and foster a false impression in the US about the efficacy of Paxil in treating pediatric depression. Furthermore, the company has allegedly controlled US physicians’ access to the negative information by controlling the information provided to its own sales personnel, who provide the company’s major promotional avenue to doctors. Unlike its June 10, 2003, press release in the UK which admitted a lack of efficacy for children and significant adverse side effects, the company’s June 19, 2003, American press release noted only that, "there is no evidence that Paxil is associated with an increase of suicidal thinking or acts and adults," and that, "not a single person [who participated in the pediatric paroxetine trials] committed suicide." It was only in May 2004 that the company finally issued a "Dear Healthcare Professional" letter to US physicians stating that medical trials for Paxil failed to demonstrate efficacy in pediatric depression. That letter still omitted the critical fact that paroxetine is now contraindicated for pediatric depression, a fact admitted by the company in Europe and Canada.

More than two million prescriptions for Paxil were written for children and adolescents in the United States in 2002. Nearly 900,000 of those prescriptions were for children whose primary diagnosis was a mood disorder, the most common of which is depression. Prescriptions for Paxil to treat mood disorders in children and adolescents translated into US sales for GlaxoSmithKline to approximately $55 million in 2002 alone.