I would think that the corporate manslaughter of men, women and children because of hidden drug company data about the dangers of a defective drug like Seroxat should rightly be deemed much more that a mere ‘Ethical Lapse’. I think ‘human rights abuse’ , ‘ grave immorality’ and ‘disturbing behavior of a corrupted industry’ would be far more accurate and descriptive statements in regards to the Seroxat Horror Show.
Lapses in ethics can only occur when there are ethical standards already in place.
‘Ethical Lapse’ … Ridiculous.
More from the Daily Mail UK
Sadly, this is not the first time the agency has been criticised for acting slowly and ineffectually.
In September 2010, for instance, the diabetes drug Avandia was finally banned in Britain after the European Medicines Agency ruled there was a serious risk it could lead to heart attacks or stroke.
Evidence against Avandia had been building since 2007.
And, while denying it had failed to reveal the risks when they showed up, in July 2010 the drug’s maker, GlaxoSmithKline, reportedly paid out £304 million in damages to settle about 10,000 patient lawsuits in the U.S.
However, in the same month an advisory body to the MHRA warned it that the ‘risks (of Avandia) outweigh its benefits, that it no longer has a place on the UK market’ and called for prompt action.
The MHRA did not reveal this warning to the public; it simply passed its information on to European authorities.
A few years earlier, media pressure was required to force the MHRA to act over another prescribed-drug danger. Again, it was a GlaxoSmithKline medicine — the antidepressant Seroxat.
Specialists had been warning for years of the raised risk of suicide in children. But the MHRA, relying on evidence from the manufacturer, issued assurances that there was no suicide link.
Then, in 2003, following two BBC Panorama programmes, the drug watchdog mounted its own investigation and discovered the manufacturer had hidden information about the suicide link.
After this, the MHRA said it wanted to require drug makers to share more information about clinical trials — but admitted that, without stronger legislation in place, there was no chance of prosecuting the company for what it called an ‘ethical lapse’.
The watchdog was not only asleep, it was toothless.