Drug trials firm to challenge plans for greater transparency over results

A judicial review will examine Health Research Authority plans for firms to publish all results, even when a drug is shown not to be beneficial

The long-fought battle for greater transparency in human drug trials is facing a major setback after a legal challenge against full disclosure from within the pharmaceutical industry.

The Health Research Authority, which authorises trials and works to ensure the safety of patients taking part, has proposed that all drug trials must in future be registered. A judicial review has now been brought by a leading clinical trials company, challenging the plans for reform.

In the past, some drug companies have airbrushed out bad results by not publishing them, which could result in a drug appearing to work better and more safely than it does in reality.

Many scientists, campaigners and health bodies have applauded the HRA’s proposals, which recently include a requirement on those running trials to ensure all previous studies they were involved in have also been registered – to try to bring historical data to light.

But Richmond Pharmacology, a company which conducts clinical trials on behalf of major pharmaceutical firms, has received permission to bring a judicial review of the HRA’s plans.

Sense About Science, one of the organisations behind the AllTrials campaign for clinical trials transparency, says it is appalled that the issue is to be brought before the courts.

“It is shocking that a company is using court action to try to stop transparency,” said Síle Lane, director of campaigns. “Hidden and unregistered trials are compromising patient care, and, rightly, causing public outrage.

“The HRA has really led the way with its proposals to check that clinical trials aren’t kept hidden during the trial approval process. Hundreds of members of the public, patients, researchers, doctors and pharmacists have told the HRA that this is exactly what it should be doing. They want the HRA to help right the injustice done to the thousands of patients who have taken part in clinical trials that have been kept hidden. I find it deplorable that one company is trying to stop that.”

The HRA confirmed in a statement that the judicial review is to go ahead. “We confirm that the claimant has been granted permission to proceed in its application for judicial review, although not in respect of all its grounds of claim.

“We would point out that the merits of the claim are not considered at permission stage. The issue of merit will be considered at the substantive hearing. The HRA is due to file detailed grounds of defence shortly, and will continue to act in line with its statutory duties and responsibility to protect and promote the interests of patients and the public in health research.”

AllTrials launched in 2013 with the aim of ensuring that all research studies should be registered. That would allow other scientists to avoid repeating a trial that may have failed as well as giving them information that could be invaluable if they are trying to develop better treatments.

The campaign – set up by a group of scientists from medical journals and the independent Cochrane collaboration as well as the author of Bad Science, Ben Goldacre – has attracted support from many leading research organisations, including the Wellcome Trust and the Medical Research Council, and a number of the medical royal colleges.

The campaigners want to ensure that negative results are just as available as those from trials that succeeded in showing a drug was beneficial. From antidepressants such as Seroxat to the flu drug Tamiflu, it has been publicly argued that some drugs have worrying side effects or work less well than the published data suggests.

Richmond Pharmacology said it was not at liberty to comment at the moment, because the case was in the hands of its lawyers.

http://www.theguardian.com/

Just what have Big Pharma got to hide, if Richmond win it will be a travesty.

Graham