loss drug that has been taken by millions of French is likely to have been
the cause of death of 500 people, the country's drug safety body announced
on Tuesday, amid claims that health authorities long ignored calls for the
drug to be banned.
second-largest pharmaceutical group was yesterday at the heart of a spiralling
health scandal over Mediator, a drug initially reserved for obese people
with diabetes that became a popular appetite suppressor.
the drug safety body, yesterday said expert epidemiologists believed Mediator,
made by Servier, had been lethal for at least 500 people and had caused
3,500 others to be admitted to hospital since its launch in 1976.
300,000 people were taking the drug when Afssaps pulled it from the market
last November, saying it had little effect on diabetes and might lead to
a dangerous thickening of heart valves. The European Medicines Agency followed
the ban was applied too slowly in France, it was claimed yesterday, given
repeated warnings of its potentially lethal side effects. Dr Irène
Frachon, who wrote a book on Mediator's dangers and warned Afssaps in February
last year, said: "The health authorities were late in withdrawing this
drug despite several alerts."
drug was pulled from Italy and Spain in 2005, according to Servier, because
it was not commercially successful enough. "Why didn't they do it earlier
[in France]?" asked Dr Frachon, whose book charts her difficulties
in getting officials to admit the drug was dangerous. The result, she added,
had been a "health disaster".
Bertrand, France's new health minister, advised anyone who had taken the
drug – but above all those who took in the past four years –
to see a doctor. "We will ask the health service to contact all patients
concerned," said Mr Bertrand just hours after taking up his new post
after a reshuffle. Hundreds of thousands could now be seeking appointments
with their doctor.
Servier group dismissed the death count estimate as "theories founded
on extrapolation". A spokesman told The Daily Telegraph: "Simply
observing a valve problem in a diabetic person does not allow it to be attributed
to medicinal treatment which remains a very rare cause."
accepting the official figures, the risk of death is only 0.005 per cent,
the company added. "You have to weigh the benefits against risks in
all drugs. If you made similar studies on others still on the market, probably
even aspirin, you'd come up with similar results."
Servier sold 145 million boxes of Mediator in France to almost three million
people. Last year, it accounted for 30 million euros (£25 million)
– less than 1 per cent of the group's 3.6 billion-euro turnover.
Bapt, a cardiologist and head of a parliamentary health commission for the
opposition Socialist party, suggested elements of the health authorities
were under the influence of France's pharmaceutical lobby. Mr Bapt pointed
out that Mediator was almost identical to another Servier drug, Isoméride,
banned in 1997. "I get the feeling some experts working for Afssaps
are very close to this laboratory," he told Le Parisien.
American equivalent, Redux, was banned in the US in 1997, leading to a $12
billion-settlement (£7.6 billion) following class action by tens of
thousands of patients.
health statement was expected to spark a rash of legal action against Servier,
already facing four lawsuits over Moderator and ordered to pay 210,000 euros
to an Isoméride patient last year.
European regulators pulled GlaxoSmithKline's blockbuster diabetes pill,
Avandia, off the market and the US Food and Drug Administration placed major
restrictions on the drug following research suggesting links to heart attacks.
governments have been extremely wary of health scandals since HIV-tainted
blood was given to hundreds of haemophiliacs in the mid-1980s. A group of
top doctors are currently on trial for indirectly causing the deaths of
117 children by injecting them with growth hormones tainted with the human
form of mad cow disease.