Healthy Skepticism Library item: 15352

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Publication type: news

Jack A.
GSK promises full drug trial disclosure
The Financial Times.com 2009 Mar 24
http://www.ft.com/cms/s/0/0976f2f2-18a7-11de-bec8-0000779fd2ac.html?nclick_check=1

Full text:

GlaxoSmithKline, the UK-based pharmaceuticals group previously accused of concealing sensitive information on its medicines, has pledged to make public the findings and details of all clinical trials within 18 months of their completion.

In its latest corporate social responsibility report, the company says it will post on its clinical study register all research on new drugs.

This includes observational studies and “meta analyses”, which analyse trends in safety and efficacy that can sometimes only be identified when studying the results of a series of different trials.

The moves follow several initiatives by GSK and other pharmaceuticals companies, partly under pressure from research funders and the publishers of academic medical journals, which have demanded greater transparency over drug trial results.

Interactive graphic
Dealmaking returns to pharma sector

GSK was pursued in relation to the risks of its anti-depressant drug Seroxat by the New York district attorney and the UK’s Medicines and Healthcare Products Regulatory Authority, which last year criticised the company for delaying several months before releasing a meta-analysis showing the dangers of its use in children.

The company also suffered two years ago when a meta-analysis conducted by academic researchers in the US suggested greater risks of side effects of its diabetes drug Avandia than similar drugs. This sharply depressed sales.

GSK and other companies have long argued that all study data is made available to regulators in order to fully assess the risks and benefits of new medicines.

Far less comprehensive data has in the past been available to outside researchers and even bodies such as the UK’s National Institute on Health and Clinical Excellence, which advises the government on whether medicines are cost effective.

The company said it would publish studies in peer-reviewed journals ”wherever possible”. In any case it would make the findings public within 18 months of their completion for approved drugs, and within 12 months of a decision to pursue or abandon the development of experimental ones.

In a wider series of initiatives designed to improve transparency and address criticism of the industry, GSK said next year it would provide a list of the advisory fees it pays to each healthcare professional it supports in Europe and the US.

Separately, the company provided further details of recent efforts to boost research on neglected tropical diseases, saying it would place 500 granted patents and 300 pending applications into a “pool”, easing access to its work by outside researchers.

It also said it would reduce prices by an average of 45 per cent on 110 products and formulations in the world’s least developed countries from the start of next month.