Monday, November 07, 2011
European Drugwatch Agency Under Investigation
The Independent is reporting that The European Medicines Agency [EMA] is under investigation by the European Anti-Fraud Office (OLAF) over allegations of conflicts of interest.
The investigation into the European medical regulator, writes Jeremy Laurance for The Independent, relates to the scandal over the French diabetic drug, Mediator, which was withdrawn from the European market in 2009, a decade after initial signs that it could be responsible for fatal heart problems.
Mediator, a weight loss drug, was banned in Europe after it was found that it caused between 500 - 2000 deaths and, it appears, the EMA didn't act quickly enough.
The crux of the investigation stems from the fact that the EMA are 80% funded by the pharmaceutical industry, much like the UK regulator who are wholly funded by the industry.
I find it odd that an investigation would start now, surely it's been public knowledge for years that this is how the system works?
It's simple really.
A drug is put up to be granted a licence - The regulator reads the supporting evidence - The pharmaceutical company provide the positive results from the clinical trials of that drug - The regulator doesn't bother asking for the negative trial results - The drug is granted a licence.
Some years down the line consumers complain of side effects, some so severe that they cause death - The regulator review the drug and give it a clean bill of health, on the odd occasion they send out warning letters to doctor's to "monitor" the patient. This covers their ass should any future deaths occur.
Everyone is happy and conscience free.
At some point a bunch of patients may kick up a stink about the drug, the regulator will hold meetings with them, appease them and make promises to investigate. They then go all out to target fake drugs flooding the European market - they can't have poor quality drugs going up against the 'safe' drugs that they have granted licence to you see.
I see no point in a regulator that is funded by the very same people it is supposed to be regulating, it's akin to asking an alcoholic to look after a crate of Vodka or giving an arsonist a gallon of petrol and a book of matches.
A spokesman for the EMA said, "We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything.
Yeh, and I've just seen a cow jump over the moon.
*Hat - Tip - Leonie Fennell
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