London Times, Friday, October 1st, 1999

'Thousands are killed' by drugs trials secrecy



The Government must force companies to report all their drug trials, senior doctors demanded yesterday, after new evidence that withholding information  had  led  to thousands of deaths.

It was grossly immoral of corporations to fail to publish results because a drug did not perform as well expected, scientists at a meeting held by the British Medical Journal and the Lancet said. Drugs companies hold back unfavourable results because they make their stock prices plummet, according to lain Chalmers, director of the Cochrane Collaboration, which campaigns for greater access to the results of trials.

Dr Chalmers said that drugs companies complained that releasing this information leads to "a window of vulnerability. In their commercial armour". But he claimed that their secrecy has led to tens of thousands of unnecessary deaths because doctors did not realise soon enough that a drug was dangerous.

Information on such important topics as genetically modified food or more effective but cheaper drugs was also suppressed, Dr Chalmers said. A trial that questioned the practices of the World Health  Organisation  was suppressed because it wouldhave made them look foolish, he said.

"Researchers who under report their results are guilty of scientific and ethical misconduct," Dr Chalmers said. He was backed up by the editors of the two leading medical journals and Britain's network of ethics committees.

"The situation is a muddle and a disaster — and the human costs can be substantial," he said.

The scientists called for action from Liam Donaldson, the Chief Medical Officer, when he speaks on the matter
at a medical conference on Monday. He should order drug companies  and all researchers to report their activities and place the information on a web site, they said.

So far, only Spain obliges drug companies to publish data, but this year the United States Food and Drug Administration took steps towards a centralised archive for all medical research. Dr Chalmers said that this was desperately needed to prevent incidents such as the suppression of trials showing that a heart disease drug was potentially deadly. In 1980, researchers found that nine patients died in a trial of a "class one" heart disease drug called lorcainide.

The drug was abandoned and that research suppressed by the drug company and published only 13 years later. In the meantime, other class one drugs were causing 20,000 to 70,000 deaths a year, more than died in during all the years of the Vietnam war.

So far, only two British drug companies,  GlaxoWellcome and Schering Health Care, have agreed to publish their scientific data on licensed drugs. This does not go far enough, said the doctors, who want all trials published, even if the drugs are abandoned for being dangerous.
Provisional website to show information
on trials already published