FDANews
FDAnews Drug Daily Bulletin

UK Tamiflu Flap Prompts Calls for Greater Clinical Trial Transparency

Jan. 7, 2014

In light of revelations that the UK government spent $700 million to stockpile Tamiflu, a British legislative committee is calling for increased clinical trial transparency to help allay cost-benefit concerns associated with that and other medical treatments.

The Public Accounts Committee (PAC) on Friday released a report calling on the government to ensure complete results from clinical trials of drugs currently marketed in the UK are available to doctors and researchers, echoing efforts already afoot in the EU.

The committee noted that, in addition to spending $700 million on Tamiflu (oseltamivir), the Department of Health was forced to write off about $121 million due to poor recordkeeping by the National Health Service on how the drug was stored during the 2009 influenza pandemic.

Roche last year said it was open to providing reviewers at The Cochrane Collaboration — a group of trial transparency advocates — access to clinical study reports for all 74 Roche-sponsored trials on its flu drug. Researchers have lobbied since 2009 for the Swiss drugmaker to hand over all its data from trials of the drug. In its defense, Roche notes Tamiflu has been approved by regulators in more than 80 countries and is used by more than 95 million patients.

In the grand scheme, “Tamiflu is just one small microcosm,” Ben Goldacre, a transparency advocate and research fellow at the London School of Hygiene and Tropical Medicine, testified before the committee earlier this summer. Goldacre notes in a 2010 NIH review, half of all the trials that have been completed for currently marketed drugs have been published — and trials with positive results are about twice as likely to see the light of day than trials with negative results.

“This is a deeply ingrained cultural blind spot for medicine, but it is one we have known about since 1986,” he said.

Industry, however, disagrees.

“It is misleading to suggest that the pharmaceutical industry routinely withholds clinical trial data from doctors and researchers,” Bina Rawal, research, medical and innovation director at the Association of the British Pharmaceutical Industry, said Friday. “We recognize that there is still work to be done and we are continuing on a journey to achieving greater clinical trial transparency.” — Nick Otto

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.