Drug watchdog in fraud investigation
Jeremy Laurance is 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into the European medical regulator relates to the scandal over the French diabetic drug, Mediator, which was withdrawn from the European market in 2009, a decade after initial signs that it could be responsible for fatal heart problems.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."
Emergency landing at Heathrow sparks further controversy over London airport capacity
Unrest may spread across Europe, warns Red Cross chief
French government seeks to ban extreme right-wing group
BNP and EDL accused of attempt to fuel racial hatred after Woolwich terror attack
You want to get an Eton scholarship? All you need to do is answer four (not so simple) questions
- 1 What, let gays get married? We must be bonkers
- 2 'Something passed underneath us, quite close': Airbus A320 has close encounter with UFO
- 3 Rocky Horror star Tim Curry 'suffers major stroke'
- 4 Exclusive: How MI5 blackmails British Muslims
- 5 Lord of the Sings: Sir Christopher Lee, 91, to release heavy metal album
BMF is the UK’s biggest and best loved outdoor fitness classes
Find out what The Independent's resident travel expert has to say about one of the most beautiful small cities in the world
Nook is donating eReaders to volunteers at high-need schools and participating in exclusive events throughout the campaign.
Get the latest on The Evening Standard's campaign to get London's children reading.
Win anything from gadgets to five-star holidays on our competitions and offers page.