Servier Aims to Prove
Safety of Its Diet Pills
By DOUGLAS LAVIN and STEPHEN D. MOORE
Staff Reporters of THE WALL STREET JOURNAL
Laboratoires Servier SA, the French drug company that pulled its popular
diet pills from pharmacies world-wide this week, believes it will be able to
prove the safety of its products and resume marketing them.
The financial impact of Servier's decision to "suspend" sales will likely be
huge as the products, which Servier has marketed to some 70 million
people in 85 countries over the past 35 years, were the closest thing this
maker of little-known prescription drugs had to a hot consumer product.
But the diet drugs account for only about 8% of closely held Servier's
revenue, which totaled 6.2 billion French francs ($1.04 billion) last year,
and it's difficult to precisely measure the financial impact on the firm,
which is still controlled by the doctor and pharmacist who founded it in
1954, Jacques Servier. Arvind Desai, an analyst with New York-based
investment research firm Mehta & Isaly, estimates the direct cost of a
voluntary withdrawal at about $200 million.
'Extreme Precaution'
The recent controversy follows a steady fire of attacks on the Servier drugs
by European health officials. And aside from the massive decision to
suspend sales, Servier is responding to the latest controversy in the same
manner as it has in the past: It is insisting the drugs -- dexfenfluramine and
fenfluramine -- are safe.
"We haven't taken our drugs off the market. We've suspended their sale,"
said Jerome Libiot, a medical doctor and the head of communications at
Servier, who was part of a small crisis-management team that met over the
weekend to decide how to respond to the latest news: an alert from the
U.S. Food and Drug Administration last Friday linking the drugs to
heart-valve problems.
Servier says there is no causal link between its drugs and any heart-valve
problems, and it only suspended the sale as a matter of "extreme
precaution."
"The debate surrounding these drugs has become heavy and extremely
passionate. So we're suspending the sale, during which time we'll
continue our research. This is a catastrophe for obese patients
everywhere," Dr. Libiot said. He said the company hopes to establish the
safety of the products and resume marketing them.
Liability Issue
Unlike its U.S. marketing partners, American Home Products Corp. and
Interneuron Pharmaceuticals Inc., Servier isn't threatened by massive
liability problems. Modest damage awards traditionally granted in product
liability cases across Europe, combined with sky-high legal costs and a
lack of contingency fees, likely will hold down the number of lawsuits
hurled at Servier, attorneys say. "Unless they can make a good case, a lot
of would-be plaintiffs might have difficulty getting a lawyer to take them
on," said Christopher Clarke of London-based law firm Brick Court
Chambers.
Servier lashed out at the medical evidence behind the FDA alert, saying the
studies were conducted without the benefit of a control group. And it
argues that vascular problems in the U.S. may be tied to the unauthorized,
but popular U.S. use of a drug cocktail, called fen-phen, because users
take both the Servier-developed drug, fenfluramine, with another drug,
made by a variety of companies, phentermine. Suspicion in Europe is
centering on the use of phentermine in part because distribution of the drug
isn't allowed here.
But the FDA alert applied to fenfluramine and dexfenfluramine because
U.S. evidence suggested that they are linked to heart-valve problems when
used alone. Dexfenfluramine is sold as Redux in the U.S. and as
Isomeride in France, where fenfluramine is sold as Ponderal.
Swedish Limits
European health officials have been questioning the safety of the diet drugs
for years. As early as 1984, Sweden's drug regulatory agency,
Laekemedelsverket, tried to block approval of fenfluramine because of
concerns about potential side effects. An appeals court overruled the
agency, but strict limits were imposed in 1988 when the Swedish agency
became concerned about links to depression and psychosis.
Only a few hundred patients a year have been allowed to take the drug after
the regulatory agency approved each individual prescription. It only
allowed the drug in cases of extreme obesity combined with additional risk
of heart disease when patients had failed other weight-reduction programs.
In 1991, a team of French doctors at the Hospital Antoine-Beclere raised
questions about a serious increase in primary pulmonary hypertension, a
rare but fatal lung disease, among patients taking the drugs. After a
Servier-financed McGill University study seemed to confirm the
pulmonary problem, the French drug regulatory agency responded in
November 1995 by dramatically restricting the number of doctors who
could prescribe the drugs.
As a result, sales of all diet pills in France -- a market almost completely
dominated by the two Servier products -- fell to 4,000 packages of pills a
month from 400,000 packages a month, said Didier Tabuteau, the general
director of France's Agence du Medicament, the regulatory agency.
'Extremely Serious' Risk
"I basically stopped the sale of the drugs," Mr. Tabuteau said. "The risk is
small, but it is extremely serious," he said of the pulmonary problem. In
December 1996, the European Medicines Evaluation Agency, the
European Union's coordinating body, endorsed the French position and
encouraged member countries to limit the use of the drugs.
But Servier fought back and appealed both decisions. "The European and
French decisions to limit the prescriptions are materially catastrophic and
morally terrible because we are being treated as murderers, without any
proof," Dr. Servier was quoted as saying by Le Monde newspaper last
year. He declined to be interviewed for this article.
Belgium is the only European country so far to report cases of the
heart-valve abnormalities uncovered by the FDA, said Bengt-Erik Wiholm,
a senior physician at the Swedish agency. So far, the European Medicines
Evaluation Agency hasn't taken official action of its own about the safety
warnings coming from the U.S. But the agency is scheduled to take up the
subject next week. |
