Pulmonologist Irene Frachon first alerted French health authorities of heart problems among patients who had taken the drug. -- AFP

PARIS: France's
medicines watchdog will join a pharma firm in the dock from Monday on fraud and
negligence charges linked to the deaths of multiple people prescribed a
diabetes pill for weight loss despite safety concerns. At least 500 people are
thought to have died of heart valve problems in France after taking the drug,
Mediator, in a major health scandal that became the subject of a 2016 French
movie called "150 Milligrams".

Legal experts
have concluded the drug may cause as many as 2,100 deaths in the long term. The
criminal trial, with 12 individuals in the dock, will focus on 91 victims, four
of them deceased, for whom lawyers believe a link can be shown between their
illness and Mediator. The medicine was on the market for 33 years, and used by
about five million people.

Though initially
intended for overweight people with diabetes, it was widely prescribed to
healthy individuals as an appetite suppressant. Safety alerts were first flagged
in the mid-1990s, but the drug was only banned in France in 2009 -- long after
being outlawed in the United States, Spain and Italy.

Victims
"want to understand how this medicine could have been left on the market
for so long," said Charles Joseph-Oudin, who will represent about 250
complainants in the trial expected to run for six months in the Paris criminal
court. Drug manufacturer Servier and nine subsidiaries are charged with fraud
for allegedly concealing Mediator's risks, while the ANSM drug watchdog is
being pursued for negligence and allegedly dragging its feet in suspending the
drug.

'Selling poison'

At the end of the
trial, both risk a fine or an order to compensate victims. "Servier knew
that it was selling poison," said 71-year-old Joy Ercole, who took
Mediator for six months ten years ago, and said she suffered heart damage as a
result. "The unlucky ones, like me, are condemned to a slow death. My life
is ruined."

Francois de
Castro, a lawyer for Servier, said the company was "keen to come and
explain that they did not identify the risk before 2009." Pulmonologist
Irene Frachon had alerted French health authorities of heart problems among
patients who had taken the drug. She published a book in 2010, which became the
basis for a documentary movie.

In 2015, a civil
court found Servier negligent for having left "defective" medicine on
the market. It ruled that in 2003 and 2006, when the medicine was prescribed to
two claimants, "the state of scientific knowledge meant the risks of
pulmonary hypertension" and heart valve damage "could not be
ignored". The ANSM, then known as Afssaps, in 2010 linked at least 500
deaths to Mediator. Victims have submitted nearly 10,500 claims for
compensation from Servier, and many have accepted payment in return for not
taking part in criminal proceedings.

'Unpunished'

Servier's website
states it has made offers of compensation to more than 3,700 sickened people
for a total amount of 164.4 million euros ($182 million), of which 131.8
million euros have been paid out. The amounts range from a few thousand euros
per person to a million euros in one case.

About 100
witnesses are expected to take the stand, including Frachon, who told AFP ahead
of the trial it was time for justice to be served. "We cannot live in a
society where white collar crime goes unpunished," she said. The trial
will happen in the absence of a key protagonist: company founder Jacques
Servier who died aged 92 in 2014.

The 12
individuals on trial include Servier's former number two Jean-Philippe Seta,
doctors who were members of Afssaps commissions but were also paid as
consultants for pharma companies, and former senator Marie-Therese Hermange who
is accused of producing a report that was favorable to Servier.

France has seen
its share of medical scandals. These include 36 baby deaths in the 1970s linked
to a contaminated talcum powder, HIV-contaminated blood given to haemophiliacs
in the 1980s, and the recent discovery that a popular brand of breast implants
contained a cheap, industrial-grade-not medical-grade-silicone gel. - AFP