The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just completed an investigation, and it is fitting to quote the BBC story about its results.
It comes after the drugs regulator announced GlaxoSmithKline would not face criminal proceedings over claims it withheld information on Seroxat.
But they warned GSK should have been quicker to raise the alarm on the risk of suicidal behaviour associated with the antidepressant in the under-18s.
GSK has rejected claims it improperly withheld drug-trial information.
The Medicines and Healthcare products Regulatory Agency (MHRA) received data from clinical trials in May 2003 showing that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat than if they received a placebo.
Data also showed that Seroxat was not effective for treating depression in children and adolescents.
But Professor Kent Woods, MHRA chief executive said they were disappointed GSK had not given them information earlier and that drugs firms had an "ethical responsibility".
"I remain concerned that GSK could and should have reported this information earlier than they did.
"All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them.
The government decided not to pursue criminal charges, mainly because of "important weaknesses in drug safety legislation in force at the time."
Also,
Health minister Dawn Primarolo said the government would take immediate steps to secure a strengthening of the law in the UK and Europe.
She also said they wanted to make it clear to all pharmaceutical companies that, "notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health".
The Guardian reported the forceful opinions of the [UK] Mental Health Foundation chief executive, Andrew McCulloch,
It is totally unacceptable to hear that, when information can be made available at speed, young people may have taken their own lives due to a lack of transparency by a pharmaceutical company.
Woods further commented in another article in the Guardian,
I really feel there is an ethical obligation that pharmaceutical companies ought to recognise and it seems to have been lost. Twenty years ago I was a prescribing doctor and I took it for granted that if there was information relevant to the drug I was going to prescribe, then it would be available. We're talking about something which has direct relevance to health and safety.
The Guardian also noted that Woods "could not rule out the possibility that other companies were sitting on unpublished data that could cause them commercial damage."
So, in case there was any doubt, based on this UK government report, it seems very clear that GSK suppressed data about the adverse effects of Seroxat in an effort not preserve sales. This was a blatant effort to put company profits ahead of patient well-being and a slap at the integrity of the clinical science data base. This has hardly been the only case of suppression of clinical research data because it reflected poorly on some company's products or services.
And pharmaceutical executives wonder why no one trusts them anymore?
I doubt there is any way to secure the integrity clinical research short of banning all involvement by corporations with vested interests in having specific research studies come out in ways that favor their products or services.
See also the forceful comments by Dr Aubrey Blumsohn on the Scientific Misconduct Blog. He called it "a day of shame."
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