British MPs Are Calling for Transparency in Clinical Trial Data

British MPs today released a pretty damning report that criticizes how drug companies withhold results of clinical trials from the doctors and researchers who make decisions about the medicines. The Public Accounts Committee has called for the results of all clinical trials to be made available, for both past and future drugs.

The committee’s report condemned the fact that about 50 percent of trial data isn’t published, and that trials with positive results are about twice as likely to make it to publication. This obviously gives a pretty skewed picture of how effective drugs actually are. Among them: Tamiflu.

Tamiflu, the trade name of influenza drug oseltamivir, was of course the nation’s drug of choice during the 2009 swine flu pandemic, though research earlier this year suggested only half of prescriptions filled were ever actually taken. Another study suggested researchers who had something to gain from pushing Tamiflu were more likely to overestimate the swine flu outbreak. This new report now questions how effective the drug even is at treating the disease.

The accounts committee, which after all is primarily concerned with public expenditure, started their inquiry to examine the UK’s decision to spend £242 million on Tamiflu, which is produced by Swiss pharmaceutical company Roche. There’s a reason for keeping this kind of stockpile; as the report recognises, “The number one risk on the Government's national risk-assessment for civil emergencies, ahead of both coastal flooding and a major terrorist incident, is the risk of pandemic influenza.”

But, as the committee continued, there’s still no consensus on how well the antiviral medicine actually works. “The case for stockpiling antiviral medicines at the current level is based on judgement rather than on evidence of their effectiveness during an influenza pandemic,” said conservative MP Richard Bacon. “Before spending money in future to maintain the stockpile the Department needs to review what level of coverage is appropriate.”

In this case, the Department of Health ended up writing off £74 million worth of the drug—6.5 million units. They explained this waste was down to stock returned after the 2009 swine flu pandemic that might not have been stored at the correct temperature, but added that it was only actually disposed of after it exceeded its shelf-life. Along with the prescriptions allegedly never taken, that’s a lot of money down the drain.

It’s easy to point the finger at Big Pharma—and the industry has a lot to answer for—but the report also suggested that regulators weren’t doing as much as they could to get an accurate picture of drug trials. In evidence presented to the committee, Fiona Godlee, editor of the British Medical Journal, said of the UK’s Medicines and Healthcare Regulatory Agency (MHRA) and the European Medicines Agency (EMA):

They tend to take the manufacturers' word for it. It is only when slightly obsessive and very scientifically determined people, like the Cochrane Collaboration and others, actually go in and look under the bonnet, and begin to see that there are not only 15 trials of Tamiflu but 123 trials of Tamiflu, of which 74 are entirely Roche-funded, Roche-controlled - Roche has the data - that you begin to see the madness of this situation: that we are getting a very partial, incomplete, misleading picture of the effectiveness of many drugs.

The government’s review was in fact spurred by an earlier investigation into the efficacy of Tamiflu by the Cochrane Collaboration, an international non-profit. They said that since their review, which appeared in 2012, they’ve received full clinical reports from Roche, and hope to release an update early this year.

But the problem of lacking trial data extends across all medicines, and action promised by the pharmaceuticals industry generally hasn’t transpired. "This has ramifications for the whole of medicine," said Bacon. "The ability of doctors, researchers and patients to make informed decisions about treatments is being undermined. Regulators and the industry have recently made proposals to open up access, but these do not cover the issue of access to the results of trials in the past which bear on the efficacy and safety of medicines in use today."

Bad Pharma author Ben Goldacre, who leads the AllTrials campaign to publish results of all clinical trials, and who also gave evidence to the committee, hailed the Public Accounts Committee's response as an important step forward. In a statement on the campaign’s site, he explained that although the lack of transparency in trial data wasn’t news to many people, it was important for the government to take action.

"Future generations will look back at this absurd situation in the same way that we look back on mediaeval bloodletting," he added.