Healthy Skepticism Library item: 734

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Tomlinson , H .
Drug firms will publish all trial data
The Guardian 2005 Jan 7

Full text:

The world’s major pharmaceutical companies promised yesterday to reveal all the clinical trial data on their drugs in response to suspicions that they have buried negative data and put patient safety at risk. The Association of the British Pharmaceutical Industry (ABPI) and sister trade associations around the world said all their major members, including GlaxoSmithKline, Pfizer and Novartis, had agreed to publicise their trial results. The pledge follows a stiffly worded letter from the health minister Lord Warner last year to the trade body, asking why such a register had not yet been produced. The government is consulting with the industry on making it a criminal offence to mislead the regulators about any application to sell a drug. “The [database] removes the suspicion that has got a lot of press coverage, that companies hide the results of trials,” said Richard Barker, the director general of ABPI. However, campaigners gave a lukewarm response to yesterday’s announcement. Richard Brook, of the mental health charity Mind, resigned from a UK regulatory body last year over the alleged suppression of data concerning the anti-depressant Seroxat. “It is difficult not to be sceptical when the industry has so forcefully resisted greater openness until so recently,” he said yesterday. “Drugs companies still do not provide the regulatory authorities with full, raw clinical data. Instead, summaries are provided. In the past these have masked serious concerns.” Professor David Healy, a director at the department of psychological medicine at Cardiff University, said the information so far revealed by Glaxo and Eli Lilly, which have already pledged to release their data, had not been ideal. “They don’t put all the raw data and things that can be of the greatest interest [on the web] … You still get a spin on the data that’s more favourable to the company.” Dr Barker said yesterday that all safety and effectiveness data would be revealed, but added that it would not be possible to put up all the raw data as there would be too much of it. About 3,000 trials would be published every year, the ABPI said.