GlaxoSmithKline is in the firing line again after a letter published in The Lancet accused the firm of misleading regulators over clinical data for its asthma compound, Serevent (salmeterol), which is also an active ingredient in its multi-billion dollar offering Advair (salmeterol/fluticasone). However, the news has been strongly combated in a responding article from the UK drug giant.
Public Citizen, the US consumer group, said a 1996 trial - the Salmeterol Multicenter Asthma Research Trial – showed an increased risk of asthma death amongst patients taking GSK’s drug. These results have never been published, it says, despite interim results being presented to the US Food and Drug Administration in July 2003 at a review by the agency’s advisory committee. Final study data were submitted to the FDA on August 29, 2003, but included adverse event observations reported six months after the 28-day trial ended, which Public Citizen claims went against the trial’s protocol: “The inclusion of the post-study data reduced the apparent dangers of salmeterol with respect to four critical study outcomes, including asthma-related death.”
The FDA questioned the results in 2004, and in July its advisory board recommended strengthening the warning labels for both Serevent and Advair to caution about the risk of asthma-related death [[14/07/05a]]. However, the agency has yet to make its final decision. “The behavior of GlaxoSmithKline in submitting these faulty data is deplorable,” said Peter Lurie, deputy director of Public Citizen’s Health Research Group and co-author of the letter. Without “greater transparency at the FDA, we will never know how often this kind of self-serving data analysis occurs.”
However, in a hard-hitting response to Dr Lurie, the company said: “GSK has acted responsibly and transparently and communicated with a sense of urgency to ensure that healthcare professionals and patients had access to the results of SMART.” It argued that the protocol did specify both the collection of reported events during the 28-week study period and during a 6-month follow-up. The results, it stresses, were disseminated in a variety of means: the company said it issued two ‘Dear Healthcare Professional’ letters, posted notices on its website and that of the FDA, presented the results at a medical meeting in 2003, and included the information in its online clinical trial registry.
However, GSK will likely be unhappy at being back in the spotlight again as it was questions over its antidepressant, Paxil/Seroxat (paroxetine), that led to the global move towards making clinical trial data – both positive and negative – publicly available [[03/06/04a]], [[17/06/04b]].