Drugmaker GlaxoSmithKline will publish the results of all clinical studies of its pharmaceutical products and pay $2.5 million in disgorgement and legal costs to settle a civil fraud suit filed in June by New York Attorney General Eliot Spitzer alleging it withheld negative information from clinical studies about its products.
GlaxoSmithKline will be the first major drugmaker to publicly disclose information gleaned from its clinical studies, but it probably won't be the last, according to the AG's office, which will continue investigating similar allegations against other drugmakers.
"We think it's a widespread practice," said Joe Baker, Spitzer's healthcare bureau chief and a leader of the investigation. "The answer to the question, 'Are we done?' (is) no, we are not done."
Baker said that if other companies similarly disclose the results of their clinical studies, "I don't know if we'll have a problem with them."
Spitzer's suit alleged the company withheld negative information about the effects of Paxil on children. It alleged the drugmaker conducted at least five studies on the use of Paxil in children but released only one, while the others showed mixed results on efficacy. The suit also alleged GlaxoSmithKline suppressed the negative results, including those that suggested a possible increased risk of suicidal thinking and acts in some people.
In a news release, Spitzer's office said that as part of the settlement, GlaxoSmithKline "also agreed to ensure that all medical information letters and other communications it provides to doctors concerning off-label use of Paxil and other drugs will fairly and accurately reflect the safety and efficacy data from clinical studies concerning off-label use."
The company, in a news release, said that although it believes the charges were unfounded, the company agreed to pay the fine "to avoid the high costs and time required to defend itself in protracted litigation."
On June 18, after Spitzer's suit was filed, the company announced plans to create an Internet-based clinical trial register containing clinical data on all its marketed medicines.
The AG's office said results will be posted from all of the clinical studies the company sponsored after Dec. 27, 2000, the date of the merger between Glaxo Wellcome and SmithKlineBeecham, as well as "any earlier studies that may be relevant."
The studies will be presented in a standardized format with content conforming to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Spitzer's office said.
"Each clinical study summary posted on the register will contain over 20 categories of information including information regarding the effectiveness of the drug tested, the type and severity of adverse side effects the study participants experienced, whether the goals or other components of the study were changed mid-stream, and whether the study was terminated early before full completion and why," the AG said.
Baker said the standards were incorporated into the agreement because they were already in use by the company and many other pharmaceutical manufacturers, as well as regulators and academic researchers.
Baker said organizations like the American Medical Association, as well as many peer-reviewed journals, have been calling for such disclosures.
"I think our lawsuit was a catalyst to make this happen, but this was being talked about for a long, long time," he said.
"The bottom line is the information on all clinical studies, both positive and negative, will be available for the first time," he said. "The question is, 'Will doctors use it?'"
"I think physician leaders and specialists and academics will probably use it to write articles for most (other) physicians to read," Baker said. "A lot of critical minds, not just those in the FDA, can take a look at this and analyze it and ask questions."