Pharmaceutical companies will have to publish the results of all studies carried out to support an application for licensing of a new drug, says a British MEP who is examining EU legislation on clinical trials.
Glenis Willmott, a member of the Progressive Alliance of Socialists and Democrats, is the European Parliament’s rapporteur who assesses the proposed revision to the EU medicines regulation. Her report, published on 4 February, says that the existing rules allow companies to hide unwelcome news about the value of any new treatment.
“Too many results from clinical trials are misleading, biased or missing. It is time that all pharmaceutical companies and researchers made the full results of studies on new and existing drugs publicly available,” she said.
Willmott wants full results of studies on proposed new drugs to be available for independent scrutiny.
“I want to see comprehensive results from clinical trials published on a public database. A summary of the results is not enough,” she said. “Summaries written by those that carried out the research can be biased, and make a medicine sound more successful than it really is. Independent researchers need access to the results of the trial in order to verify the sponsor’s claims.”
Legislation in the US requires all results to be available within a year but those rules are often ignored, and an audit in 2012 showed that some information was missing in 80 per cent of the studies examined. So Willmott is insisting that companies should be fined if they fail to release their results.
“If we are serious about openness in medicine then we have to levy fines on those not following the rules,” she said.
Willmott argues that several academic studies have shown that around half of all trials are never published, and these are usually those with negative or disappointing results.
Willmott’s report was welcomed by one of the pharmaceutical industry’s most prominent critics, Ben Goldacre, the medical journalist and author of the book Bad Pharma on the misuse of scientific data by drug companies.
On his website, Goldacre said that Willmott’s proposals would remedy deficiencies in the existing draft regulation which is “riddled with holes: essentially it allows companies and researchers to withhold trial results, and play fast and loose with analyses”.
He insists that the European public should maintain pressure for changes to the clinical trials rules and urges them to sign an on-line petition on the issue.