A lawsuit is drawing increased attention to an issue some physicians have been pushing to improve in recent years: Doctors’ access to scientifically sound clinical trial data, especially studies that discover harmful side effects in medications.

New York State Attorney General Eliot Spitzer in June sued GlaxoSmithKline, accusing the pharmaceutical company of concealing information that would have alerted physicians that the antidepressant Paxil could be harmful to children or adolescents.

About 2.1 million prescriptions of paroxetine - a drug sold under the name Paxil and Paxil CR - were written for children in the United States in 2002, according to the lawsuit.

Nearly 900,000 of those prescriptions were to treat children’s mood disorders. An estimated one-third of such prescriptions were written by non-psychiatrists, including family physicians and pediatricians, the complaint states.

“Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients,” Spitzer said in a statement. “By concealing critically important scientific studies on Paxil, GSK impaired doctors’ ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety.”

The Food and Drug Administration approved Paxil as safe for treating depression in adults. The drug is not FDA-approved for children. As is the case for many prescription medications, pediatricians and other physicians who treat children use their professional discretion in using the drug in children.

The lawsuit alleges that GlaxoSmithKline conducted at least five studies since 1998 that evaluated Paxil‘s use in children and adolescents but only published and disseminated one. That study showed mixed results on the drug’s efficacy, according to the lawsuit.

Spitzer alleges that the company suppressed the other studies’ negative results, including findings that suggested a possible increased risk of suicide in children and adolescents who used the drug.

In addition, the lawsuit charges that an internal 1998 GlaxoSmithKline document concluded that, given the mixed efficacy outcomes in one study and negative outcomes in another study, the company’s “target” was “to effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.”

GlaxoSmithKline executives said they had acted responsibly in conducting clinical studies in children and adolescents and that they had been responsible in disseminating the findings. They said the 1998 data that Spitzer references in the lawsuit “is inconsistent with the facts and does not reflect the company position.”

“All pediatric studies have been available to the FDA and regulatory agencies worldwide,” the company said in a statement issued in response to the lawsuit. “We have publicly communicated data from all pediatric studies.”

The clinical trial findings were available in peer-reviewed journals, poster presentations at scientific meetings and medical letters to physicians, company executives said.

“This approach is accepted standard practice for making data available,” GlaxoSmithKline stated. “However, in order to clarify the nature of these data, GSK will shortly be making available summaries of the safety and efficacy data from individual reports of the clinical studies conducted with paroxetine in adolescent and pediatric patients, as well as a bibliography of public communications derived from these studies and the U.S. letter to physicians summarizing these data.” At press time, the pharmaceutical company planned to put the information on its Web site.
A broader issue

The New York State Psychiatric Assn. isn’t taking a position on the lawsuit, but association leaders said it draws attention to an issue that has been important to doctors for several years.

Some physicians have raised concerns that negative studies are less likely to be published or in some cases might be hidden by companies that sponsored them.

“There is a need for transparency,” said NYSPA President Barry B. Perlman, MD. “It is critical for doctors to know what studies have shown. This is not just about Paxil, but about all drug company research.”

The New York lawsuit came just weeks before doctors at the American Medical Association’s Annual Meeting voted to ask the Dept. of Health and Human Services to establish a comprehensive registry and electronic database for all clinical trials done in the United States.

“It’s important for physicians and patients to have access to as much information as possible to make informed decisions,” said David Fassler, MD, a child and adolescent psychiatrist from Vermont who is an American Psychiatric Assn. trustee and an AMA delegate from the American Academy of Child and Adolescent Psychiatry.

“We know that if there are enough studies done, one will show significant results by chance. If that’s the only one that gets published, it skews the perception,” he said.

Pharmaceutical Research and Manufacturers of America spokesman Jeff Trewhitt said the industry does share clinical trial information. It does so not only in medical journals, which publish only a small percentage of the studies that are done, but also at medical meetings and through other outlets.

In 2002, PhRMA adopted principles regarding communicating clinical trial results that include requirements that information from trials be disclosed.

“We are committed to timely communication of meaningful study results, regardless of the outcome of the study,” said Alan Goldhammer, PhD, PhRMA’s associate vice president for regulatory affairs. “The results must be reported in an objective, accurate, balanced and complete manner, with a discussion of the limitations of the study.”