Dr Michael Antoniou who forwarded this article notes the following, "The wide-ranging investigation, due to begin in September, will look at the influence of the [pharmaeutial] industry on medical research, the promotion of drugs and regulatory reviews of drug safety and efficacy."
Dr Antoniou says the same should happen with the biotech industry. Similarly, why can't we see the data?
British drug company to put data online as criticism mounts
Nature 429, 793 (24 June 2004); doi:10.1038/429793b
[LONDON] Things are hotting up for Britain's largest drugs firm, GlaxoSmithKline (GSK), in the wake of a legal challenge launched earlier this month by Eliot Spitzer, New York state's attorney-general.
On 18 June, the British parliament announced an investigation into the pharmaceutical industry. On the same day, London-based GSK said that it would make all clinical trial data for marketed drugs available online to the public. But two days later, British lawyers representing patient groups announced fresh legal action against GSK.
The company's online data registry, due to launch later this year, will include summaries of trial protocols and data for everything from initial toxicology and safety studies to trials run on drugs after they have been licensed. "All the important results will be there," says GSK spokesman David Mawdsley.
Results from one such post-licensing trial are important to Spitzer's case. The attorney-general alleges that GSK failed to disclose data showing that the antidepressant paroxetine, known as Paxil in the United States and Seroxat in Britain, is no more effective than a placebo for depressed young people and might even increase the risk of suicide in this group (see Nature 429, 589; 2004). The drug has been approved by US regulators for use in adults, but it is frequently prescribed to under-18s.
Mawdsley says they have been considering the registry for a while: "This is going to be a big job. We started discussing it well before the Spitzer case."
GSK is also expected to hear shortly from Hugh James, a Cardiff law firm which says it is acting on behalf of 3,500 patients who claim to have suffered withdrawal symptoms when coming off Seroxat. The company, which says it is also representing relatives of "a few tens" of people who committed suicide while on the same drug, say they will outline their claim in a letter to GSK in the next few weeks. GSK declined to comment.
Later this year, the drug manufacturer may have to defend itself on a third front, when the House of Commons opens an inquiry into the pharmaceutical industry. The wide-ranging investigation, due to begin in September, will look at the influence of the industry on medical research, the promotion of drugs and regulatory reviews of drug safety and efficacy.