Glaxo's Paxil faces scrutiny on the Hill

GlaxoSmithKline's marketing and clinical research of big-selling anti-anxiety drug Paxil - which some say leads to higher rates of suicidal behavior - is attracting new attention in Washington.

Sen. Charles Grassley (R., Iowa) this month asked the Food and Drug Administration to consider whether Glaxo withheld information from regulators.

Grassley's request was triggered by an unsealed study that claims Glaxo should have known in 1989 that Paxil could lead to higher suicide risk.

Glaxo has called the study scientifically flawed and said it was financed by plaintiffs' lawyers.

The drug company also has confirmed that Justice Department offices in Colorado, Boston and Washington are investigating its off-label marketing practices for Paxil. Glaxo, which has U.S. headquarters in Philadelphia and Research Triangle, N.C., first disclosed a federal investigation into Paxil in 2004.

"There is absolutely nothing I can provide in regard to this," Justice Department spokesman Charles Miller said yesterday.

Company spokeswoman Mary Anne Rhyne said yesterday she could not comment on the investigation and provided a statement that said the company had fully disclosed information on Paxil, which was approved for sale in 1992. Paxil has lost patent protection. Paxil CR, a later version of the drug, remains on patent but faces generic competition.

"We remain firm in our belief that we acted properly and responsibly in our clinical-trials program for Paxil, documentation and submission of results from studies to regulators, and communication of important safety information to regulatory agencies, the scientific community and the public," the company statement read.

Glaxo has faced questions for years over Paxil, which is considered a serotonin-reuptake inhibitor. The company said in its statement that it conducted many studies of Paxil over the years and that it was not until 2006 that "it noted an increased rate of suicide attempts, mainly in young adults, and the numbers were small." This information was supplied to the FDA, the company said.

Grassley said on June 11 that it appeared that GlaxoSmithKline "bamboozled the FDA" when it submitted a new drug application for Paxil in 1989 by withholding information.

GlaxoSmithKline has attempted to keep a Paxil study by Joseph Glenmullen, a professor of psychiatry at Harvard University, from the public by asking judges to seal it in lawsuits, Grassley said. A Kansas judge recently unsealed the study.

Grassley, the ranking Republican on the Senate Finance Committee, said in his statement that Glenmullen's study claims that GlaxoSmithKline, when conducting studies for Paxil, put patients who had attempted suicide before the study into control groups taking a placebo and then compared that group to people taking Paxil. Thus, the Paxil group compared favorably with the suicide-prone placebo-takers, he said.

GlaxoSmithKline said in its statement that Glenmullen is "not an independent expert. His methodology is scientifically flawed and unreliable." The company said only plaintiffs' experts use the Glenmullen conclusions.

Grassley has asked the FDA to scrutinize the information it received from GlaxoSmithKline on Paxil and to review findings by a British drug-safety agency that claimed the drug maker knew since 1998 about a suicide risk among children using Paxil.

An FDA spokeswoman said the agency would respond directly to Grassley.