Thursday, May 12, 2011
Shadow falls over European drug regulator [EMA]
In my book, 'The evidence, however, is clear...the Seroxat scandal', I highlight the UK drugs regulator [MHRA] and their cosy relationship with GlaxoSmithKline and the rest of the pharmaceutical industry.
In fact, when I first started asking questions regarding the safety of Seroxat [Paxil in US] the MHRA's responses were less than transparent - it took Freedom of Information requests [FOI] for me to get some sort of answer from them, even then the answers were vague.
It appears that the European drugs regulator are pretty much the same, according to an article published in yesterday's Independent.
The EMA were sent FOI's from Professor Peter Gotzsche and Anders Jorgensen from the Danish Cochrane Centre, they wanted to investigate two obesity drugs, orlistat and sibutramine. They requested the unpublished trial data from the EMA in 2007.
The EMA refused access to the studies citing "commercial confidentiality" whilst defending their corner by arguing that they constantly monitored drugs and updated their assessments.
Orlistat is marketed as a prescription under the trade name Xenical by Roche in most countries, or over-the-counter as Alli [GlaxoSmithKline]
Quite a coincidence that GlaxoSmithKline recently announced that it is to sell off Alli and will, in the forthcoming weeks, be contacting parties interested in its product.
Sibutramine is better known by its brand name, Reductil, [Abbott] ironically suspended by the MHRA in January 2010 after the EMA informed them to suspend its licence in Europe amid fears that it raised the risk of heart attacks and strokes in patients taking it, this some three years after the request for the unpublished trial data was made by Professors Gotzsche and Jorgensen.
Eugene Sun, an Abbott spokesperson said at the time, "We believe there are many patients who benefit from sibutramine and respectfully disagree with the recommendation to suspend the medicine."
No surprise there then.
Gotzsche and Jorgensen, unhappy with the EMA's refusal to supply the unpublished trial data in 2007, wrote to the European ombudsman who, in 2010 [Yes, three years later] criticized the EMA's refusal to grant access to the trials and added that the EMA was guilty of maladministration.
Gotzsche and Jorgensen finally received the unpublished data in February 2011, some four years after they first requested it.
This is yet another example of the regulator protecting the pharmaceutical industry. To cite "commercial confidentiality" as an excuse to not release data is woeful, what about "consumer protection"?
I am not shocked any more by the regulators decisions, it appears that protecting the manufacturers is much higher on the agenda than protecting the consumer.
Further evidence of the collusion between the regulators and the pharmaceutical industry reared its ugly head back in June 2010 when I learned that the UK Seroxat litigation's defendants, GlaxoSmithKline, had hired the services of Rashmi Shah to be called as an expert witness for them. Shah was employed by the MHRA between 1987 and 2004.
I've met with various MHRA officials on numerous occasions. Their CEO, Kent Woods, gave up over an hour of his time to sit down with me and listen to my concerns regarding the difficulties patients were having withdrawing from SSRi medications. He even agreed that the MHRA should meet with Prof. David Healy, who had drawn up a withdrawal guidance to help patients withdraw from SSRi's. The meeting between Healy and the MHRA took place, Healy showed them the protocol... it still remains on the table collecting cobwebs!
More about the MHRA, GlaxoSmithKline and Seroxat in my book, which can be purchased online in the US and Canada HERE and in the UK HERE.