EU red tape on clinical trials seen as deadly

Red tape is smothering new medical research in Europe and killing patients by limiting large clinical trials that test whether new medicines are safe and effective, researchers said on Thursday.

Regulatory hurdles—stemming mainly from a 2004 European Union directive aimed at increasing scrutiny of clinical trials - are also pushing research and badly needed investment to other parts of the world, they added.

“The hugely increased bureaucratic hurdles have made it difficult to do these large, multi-centre trials, and I believe this is killing people,” Rory Collins, an epidemiologist at the University of Oxford in Britain, told a news conference.

Collins, fellow researchers and the chief executive of Britain’s medical regulatory watchdog, said that, while well-meaning, the European-wide directive on clinical trials has led to serious delays and added millions of pounds to costs.

The directive, which took effect in 2004, aimed to impose tighter controls on monitoring and reporting drug trials in a bid to boost patient safety.

Supporters point to the withdrawal that same year of Merck & Co Inc’s Vioxx after the drug was linked to increased risk of heart attack and strokes as reasons why tighter controls were needed.

There was also concern the pharmaceutical industry, which has produced a raft of life-saving medicines over the years, had increasingly become focused on marketing rather than science.

Collins and the others said the regulation had gone too far and it was now difficult to do large-scale trials across borders—the kind of research that provides life-saving evidence of whether certain drugs or techniques are safe and effective.

“At the moment people are dying unnecessarily because the way regulation is working is preventing patients from getting the care they need,” Collins said.

The researchers also say investment dollars are flowing elsewhere. In 2002, the number of clinical trials in Britain accounted for 6 percent of the world’s total before dipping to 2 percent five years later, according to John Bell, president of Britain’s Academy of Sciences.

At the same time number of clinical trials in the Asia-Pacific region jumped from 2 percent of the total to about 10 percent, evidence the researchers say highlights the need to tweak the laws to lure that research back to Europe.

Kent Woods, head of Britain’s Medicines and Healthcare Products Regulatory Agency, said there had been progress in streamlining European-wide regulation to make it easier to conduct large clinical trials.

He and the others agreed that differentiating between research using experimental drugs or so-called first-in-man trials and ones looking at widely used medicines whose safety is proven could go a long way toward solving the problems.

By Michael Kahn
LONDON (Reuters)