Access to all clinical research data urged

23 October 2012

The Tory MP Dr Sarah Wollaston has called for all past and future clinical study reports to be published amid allegations that pharmaceutical companies have been deliberately stifling bad news about the effectiveness of drugs and their possible side effects.

The companies have denied that they withhold the results of adverse clinical trials from doctors but Wollaston has raised the issue in parliament, calling it a "scandal of missing trial data".

The plan – backed by doctors, scientists and academics – is to change the law so that doctors and patients are given access to all clinical research. Supporters include the editors of the Lancet and the British Medical Journal and Sir Ian Chalmers, founder of the Cochrane Library.

Academic and author Dr Ben Goldacre – who says he specialises in unpicking dodgy scientific claims from drug companies, newspapers, government reports, PR people and quacks – is backing Wollaston's stance.

On his Bad Science website, he said: "Apparently this morning the Department of Health issued a statement... that all data from all trials on all drugs is already available by law. This is not true."

He also wrote: "Doctors need the results of clinical trials to make decisions. Unfortunately, drug companies and researchers are allowed to withhold information about clinical trials from doctors and patients if they wish to. This means that we are misled about the benefits and risks of treatments. We can be misled into prescribing an expensive new drug, for example, when in reality an older cheaper one is more effective. Patients are harmed and money is wasted.

"This problem is extremely well documented in medicine, and widely discussed within the profession. Legislators have failed to engage on the issue. Our current best estimate is that half of all the clinical trials that are conducted and completed are never published in academic journals, and trials with positive results are twice as likely to be published."

In his book Bad Pharma, Goldacre claimed that drug companies were harming patients around the world by distorting evidence on an industrial scale and doctors, academics, and regulators had failed to fix the problem. Bad practices have been perpetuated because the public have not understood the true scale of the disaster, he wrote.

Referring to the European Medicines Agency, Goldacre tweeted to Wollaston: "So the likelihood of them suddenly popping up with a functioning register of trial results is low, unless their feet are held to the fire."

Wollaston responded: "We must light that fire, and grasp their legs firmly. http://bit.ly/Ri2WTu something higher up I suggest!"