Stricter regulations are needed to curb biased under-reporting of clinical trials conducted by pharmaceutical companies, as the industry cannot be trusted to self-regulate in this area, according to Sir Iain Chalmers, a former director of the Cochrane Centre and now editor of the James Lind Library.
The comments, published in the current issue of the Journal of the Royal Society of Medicine, have been made despite public statements by a number of drug companies in recent months that they are setting up registries to make information on all their clinical trials public.
The impetus came from a high-profile case in 2004, in which GlaxoSmithKline was accused by US attorney general Eliot Spitzer of withholding the results of negative clinical trials of its Paxil (paroxetine) antidepressant in children and adolescents.
GSK eventually paid $2.5 million to settle the claims and set up a registry of its own clinical trials, other companies followed its lead, and in January 2005 world's major pharmaceutical industry trade associations from Europe, Japan and the USA announced they were setting up registries for their members.
But these measures simply don’t go far enough, according to Sir Iain, and he calls upon all companies to publicly endorse the Good Publication Practice Guidelines for Pharmaceutical Companies, a document drawn up by employees at GlaxoWellcome that was dropped after it merged with SmithKline Beecham to form GSK, while the employees who drafted them were dismissed.
“If GSK really is committed to the kind of openness the public has come to realise is needed, one might have expected it to have endorsed the Good Publication Practice for Pharmaceutical Companies Guidelines developed by its dismissed former employees and colleagues in other companies. It has not,” writes Sir Iain in the JRSM article.
“Indeed, at the time of writing, only six pharmaceutical companies have endorsed the guidelines - Aventis, Amgen, LEO Pharma, Otsuka, Serono and 3M Pharmaceuticals,” he continued.
Current UK guidelines suggest that all clinical trials, both positive and negative, should be published within a year of being approved for new drugs, and within a year of the trial concluding for medicines already on the market. The GPP document recommends that all trials should be publicised, at the outset, including full details of the study protocol and objectives.
Meanwhile, the medical profession does not escape censure from Sir Iain. “It is particularly disappointing that many doctors collude with the industry in this form of scientific misconduct. They have too often simply acquiesced in scientific misbehaviour driven by the marketing departments of pharmaceutical companies,” according to Sir Iain.
“Biased under-reporting of research harms and sometimes kills patients, quite apart from the waste of resources that results from this form of scientific and ethical misconduct,” he said.