Drug watchdog in fraud investigation
Jeremy Laurance is a writer on health issues. He is former health editor of The Independent and the i and has covered the specialism for more than 20 years. He thinks the harm medicine does is under-appreciated, the harm it prevents over-rated, and that cycling works better than most drugs. He was named Specialist Journalist of the Year in the 2011 British Press Awards.
Monday 07 November 2011
The safety of medicines in the UK has been cast into doubt by a fraud inquiry at the European regulator responsible for licensing pharmaceutical drugs across the EU.
The European Medicines Agency, based in Canary Wharf, London, is under investigation over alleged conflicts of interest by the European Anti-Fraud Office (OLAF). If proven, the allegation would undermine confidence in the pharmaceutical industry which is already reeling from a series of disasters involving heavily publicised medicines, which later turned out to have deadly side effects.
The British multinational GlaxoSmithKline announced last week it would pay $3bn (£1.9bn) to settle US criminal and civil investigations into its sales practices, after the withdrawal of diabetes drug Avandia in 2010 due to an increased risk of heart attack.
The investigation into the European medical regulator relates to the scandal over the French diabetic drug, Mediator, which was withdrawn from the European market in 2009, a decade after initial signs that it could be responsible for fatal heart problems.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, made by French pharmaceutical firm, Servier, was on the market for 33 years and was prescribed as a weight loss drug taken by an estimated 5 million people in France and by many more in Italy and Spain. It is estimated it caused between 500 and 2,000 deaths, mainly from heart valve problems, before it was banned. Mediator was not marketed in the UK, but the fallout from the scandal has damaged confidence in the drug regulatory system.
The chief executive of the French regulator, the Health Products Safety Agency, resigned and the body which he headed was overhauled after a damning official report said it "failed in its duties." The reformed regulator, renamed National Agency for the Safety of Medicines (ANSM), includes new measures to guarantee transparency and avoid conflicts of interest.
The investigation into the EMA was triggered by Michèle Rivasi, a French Member of the European Parliament for Europe Ecologie Les Verts, a green party. She has pointed out that 80 per cent of its budget comes from the pharmaceutical industry making independent oversight impossible.
The EMA was created in 1995 to harmonise drug regulation systems in the EU. It said last month it had "strengthened the rules on how it handles potential conflicts of interest of its staff and experts" after it was criticised by the agency's Budgetry Control Committee.
Olaf told The Independent its investigation into the agency opened in July but could not give details "for reasons of judicial secrecy". The EMA said it knew of the probe but had not seen the accusation. A spokesman added: "We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything."
How the language you speak changes your view of the world
'Fire at every person you see': Israeli soldiers reveal they were ordered to shoot to kill in Gaza – even if the targets may have been civilians
Italian police 'reveal' what Jesus looked like as a young boy
First-time buyers in London 'need to earn at least £77,000'
General Election 2015: Photographic history of Bullingdon Club tracked down - including new picture of David Cameron in his finery
Over 50,000 families shipped out of London boroughs in the past three years due to welfare cuts and soaring rents
In defence of liberal democracy
EU asylum policy is 'a direct threat to our civilisation', says Nigel Farage
The Rothschild Libel: Why has it taken 200 years for an anti-Semitic slur that emerged from the Battle of Waterloo to be dismissed?
General Election 2015: UK will be 'run for the wealthy and powerful' if Tories retain power, Labour warns
Schools forced to act as 'miniature welfare states' with teachers buying underwear and even haircuts for poor pupils
- 1 How the language you speak changes your view of the world
- 3 Italian police 'reveal' what Jesus looked like as a young boy
- 5 YouTube social experiment shows just how easy it is to kidnap a child