Healthy Skepticism Library item: 15340
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Publication type: news
Mansell P.
GSK steps up commitment to research transparency
Pharma Times 2009 Mar 25
http://www.pharmatimes.com/clinicalnews/article.aspx?id=15559
Full text:
GlaxoSmithKline (GSK) has sought to draw a line under the reputation for data distortion that has plagued the company since its tangles with regulators and the media over the antidepressant Seroxat/Paxil (paroxetine) by announcing a clutch of initiatives to enhance the transparency of its clinical research.
The measures are disclosed in GSK’s latest annual Corporate Responsibility Report, which recognises the company’s “unique and privileged” position. “Continually strengthening our contract with society is vitally important, and this is why we are fully committed to operating to the highest ethical standards,” commented chief executive officer (CEO) Andrew Witty.
According to GSK, it has already taken “substantive steps to be transparent with its clinical research and interaction with health professionals”, including the Clinical Study Register originally launched by the company in 2004 and revised in 2008. To date, though, the register has not included data reviews such as meta-analyses.
An analysis of pooled clinical data from nine paediatric studies with Seroxat was at the heart of GSK’s row with the Medicines and Health products Regulatory Agency (MHRA) in the UK. The agency accused the company of sitting on data from clinical trials that pointed to an increased risk of suicidal behaviour in patients under 18 years of age given Seroxat.
With effect from January 2009, the Clinical Study Register will include all analyses of multiple clinical trials (i.e., meta-analyses), observational studies that use patient data from real-world settings and clinical data from research programmes that have been terminated in development.
GSK has also committed to submitting clinical study results as manuscripts for publication in peer-reviewed journals “wherever possible”. For studies that are not published, the company will provide “context and interpretation” in the Clinical Study Register to supplement the results summary, the Corporate Responsibility Report notes.
Other newly announced transparency initiatives are:
• For GSK-sponsored clinical trials starting from January 2009, the names of participating investigators and the institutions they work for will be included in the protocol information posted to the Clinical Study Register.
• For clinical trials starting from 2010, GSK will publicly report payments to US healthcare professionals and/or the institutions for conducting the study. This measure will subsequently extend to payments for other types of research and to healthcare professionals and institutions outside the US.
• The company will also report advisory fees paid to healthcare professionals in Europe. This is in addition to GSK’s previously announced commitment to publish, with effect from 2009, a report on speaking and consulting fees paid to US healthcare professionals.
The MHRA’s case against GSK over alleged data-hoarding with Seroxat fell down because, under the prevailing legislation (the investigation was launched in October 2003), it did not offer any realistic prospect of a conviction. However, GSK was strongly and publicly rebuked by MHRA CEO Professor Kent Woods over its failure to report the paediatric findings more promptly.
In August 2004, moreoever, the company paid New York state in the US $2.5 million to settle claims by then New York Attorney General Eliot Spitzer that the company had concealed important information about the safety and efficacy of Paxil in children and adolescents.
Recently Pfizer announced that, starting next year, it would disclose payments not only to healthcare professionals and major institutions conducting clinical trials, but also to all principal investigators for those trials. “This makes Pfizer the first biopharmaceutical company to commit to reporting payments for conducting Phase I-IV clinical trials in addition to disclosing payments for speaking and consulting,” the company stated.
