Drug Maker Withheld Paxil Study Data

Dec. 9, 2004 — -- New documents uncovered by ABC News suggest GlaxoSmithKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk of suicidal behavior in some children taking the drug, as well as serious withdrawal symptoms when some patients stop taking Paxil.

The new documents obtained by the ABC News program "Primetime Live" have never before been made public. Earlier this year, the Food and Drug Administration ordered manufacturers to place a warning in bold print on antidepressants, alerting consumers that the drugs can cause suicidal tendencies in children and teenagers.

The FDA's move raised the issue of how much antidepressant manufacturers knew about this increased risk and when.

While Congress and the FDA have held hearings questioning GlaxoSmithKline and other drug manufacturers about suppressing studies that cast their products in a negative light, "Primetime Live" has obtained actual copies of GlaxoSmithKline reports from its own internal studies. In these studies, some children showed the same types of suicidal thoughts and behaviors that parents had for years claimed their children were exhibiting.

According to these documents, internal studies by GlaxoSmithKline concluded that Paxil had little or no effect in treating depression in children and adolescents. And as far back as 1997, the company was aware of studies reporting suicide-related behaviors in young patients taking the drug.

In spite of this information, GlaxoSmithKline distributed a memo to its sales force in 2001 touting the drug's "remarkable efficacy and safety in the treatment of adolescent depression."

See the memo.

Additionally, the internal documents reveal GlaxoSmithKline had scientific evidence Paxil could cause mild to severe withdrawal symptoms in some patients when they abruptly stopped taking the drug. A document the company distributed to sales staff referred to "withdrawal symptoms" and said they included problems like dizziness, nausea, fatigue, insomnia and nightmares, but advised the sales representatives to use the less-alarming term "discontinuation symptoms." The documents suggest GlaxoSmithKline's sales strategy was to downplay this information in order to maintain its share of the billion-dollar antidepressant market.

"This is about money," said Rep. Henry Waxman, D-Calif., who is on a congressional committee investigating antidepressant manufacturers. "This is not about science, because what they're doing is withholding the scientific information, suppressing the studies that could have a negative impact on their sales and their profits."

In addition to the investigation by Congress, the New York attorney general's office in June of this year leveled charges of consumer fraud against GlaxoSmithKline. The lawsuit alleged that the drug giant repeatedly concealed information about Paxil from doctors.

The attorney general's lawsuit noted that GlaxoSmithKline conducted at least five studies of Paxil's use in children and adolescents, but the company only published one of these studies -- a decision at the heart of the controversy.