PUBLIC CITIZEN: MISLEADING CLINICAL STUDY MAY BOLSTER FACT ACT

A major drug manufacturer's alleged manipulation of a clinical study may bolster the prospects of Senate legislation that would require drugmakers to submit all clinical trial results to an electronic database, activists say.

Public Citizen argues in a recent article in The Lancet that GlaxoSmithKline (GSK) manipulated data in a clinical study of its asthma drugs Serevent (salmeterol xinafoate) and Advair (fluticasone propionate/salmeterol xinafoate) to downplay their risks.

Specifically, the consumer group contends GSK included additional data gathered after the original study was supposed to end in order to find a lower risk of deaths and illness from using the drug.

GSK has denied Public Citizen's charges, stating in a reply published in The Lancet article that it "acted responsibly and transparently" and communicated the study results "with a sense of urgency."

Peter Lurie, deputy director of Public Citizen's Health Research Group, said the GSK incident provides an example of why there needs to be more public access to clinical trial data. According to Lurie, the GSK dispute could boost the prospect of a Senate bill that calls for improved clinical trial reporting.

The bill, known as the Fair Access to Clinical Trials (FACT) Act, would require drugmakers to submit clinical trial results to an electronic database or face stiff monetary fines. The proposal, S. 470, has been stalled in the Senate Health, Education, Labor & Pensions Committee since it was introduced Feb. 28 by Sens. Chuck Grassley (R-Iowa) and Christopher Dodd (D-Conn.).

GSK's study provides a vivid example of why the FDA's current practice of only providing access to clinical data before agency advisory committee meetings is flawed, Lurie said. "Absent greater transparency at the FDA, we will never know how often this kind of self-serving data analysis occurs," he said.

While the FDA had required a 28-week study of Serevent, GSK also included an additional six months of results without telling the agency of the change, Public Citizen alleges. It was only after the FDA had inquired about the length of the trial that GSK admitted it included the six-month data, the group adds.

GSK contends it did everything it could to ensure Serevent and Advair data were made available. "GSK worked with FDA continuously to ensure they had the information needed to evaluate the safety of this medicine," company spokeswoman Patty Johnson told FDAnews.