Wednesday, September 08, 2004

Drug Trial Secrecy Puts Patients at Risk

Tue 7 Sep 2004
9:48am (UK)
'Drug Trials Secrecy Putting Patients at Risk'
By John von Radowitz, Science Correspondent, PA News

Patients are being put at risk because of the secrecy of drug companies which refuse to publish the results of clinical trials, it was claimed today.

New research suggests that data from more than a quarter of cancer trials may never reach the public domain.

In many cases the results are hidden, either to stop commercial rivals learning too much or because the findings are negative, say experts.

Experts from the Cancer Research UK charity today said they were worried about doctors and surgeons being hampered by the inaccessibility of trial data.

Secrecy could also lead to the unnecessary duplication of research, wasting hundreds of thousands of pounds, they said.

Dr Richard Sullivan, head of clinical programmes at Cancer Research UK, said: “The medical community needs to know the results of clinical trials to be able to view the entire picture of how a treatment works, how it compares to other therapies and what choices could serve patients best.

“It’s disturbing to think that important information on clinical trials is being left to gather dust.”

One study looked at 500 cancer trials and found that 26% had failed to publish their full results five years after presenting early data at a leading American conference.

Trial investigators cited lack of time and shortage of funds as their main reasons for not publishing.

But Dr Sullivan said there was a perception among drug companies that publishing early data might help the competition.

His colleague, Professor Fran Balkwill, head of translational oncology at the Cancer Research UK Clinical Centre in London, whose job is to transfer basic discoveries to the clinic, said: “All scientists, whether clinical or not, have a responsibility to make sure their data is accessible to the wider community.”

The two charity experts voiced their concerns today at the British Association Festival of Science at the University of Exeter in Devon.

They said a comprehensive database of all clinical trials was needed to monitor research progress and ensure information was published.

Dr Sullivan said it was not possible to make any predictions about lives lost because of missing data.

But he cited the example of the 20,000 to 26,000 people in Britain receiving chemotherapy for lung cancer. About a quarter of them were likely to be receiving sub-standard treatment, he said.

Dr Sullivan added: “We’re entering an era of increasing complexity when treating patients.

“Every piece of information is going to be hugely valuable. The days when there was lots of wasted information in clinical trials that didn’t really matter are gone.”