French doctors demand to know why drug stayed on the market for so longBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c6882 (Published 03 December 2010) Cite this as: BMJ 2010;341:c6882
All rapid responses
The Benfluorex Scandal: Effective ADR monitoring and post-marketing surveillance could prevent tragedy.
Benfluorex is an appetite suppressant drug. It is also used to lower
the levels of blood lipids and lipoproteins. It has been claimed to help
in the improvement of glycemic control and play a role in decreasing
insulin resistance in the patients of type 2 diabetes mellitus .
Primarily used for treating diabetes, benfluorex has been used off-label
for reducing obesity .
France's national health-insurance organization (CNAM) suspected its
involvement in 500 deaths and at least 3500 hospitalizations in France
since 1979. CNAM reported the same to the French Agency for Safety of
Health Products (AFSSAPS). Several investigations have pointed to the
possible 'lethality' of benfluorex .
Recently, AFSSAPS has advised the people having used this drug from 2006
to 2009 to undergo medical examination to rule out the possibility of
heart valve problems .
The European Medicines Agency (EMEA) - the organisation entrusted with the
monitoring of drugs for use in European Union - has recently recommended
the withdrawal of all benfluorex medications in the EU countries .
French doctors have correctly raised the issue of this drug with the
government . It is really surprising to note that such a drug was able
to stay in the French market for 33 long years. It also points out that
something is missing in the ADR monitoring and post-marketing surveillance
studies results. No studies or investigations can ever compensate for the
loss of human life attributable to benfluorex and the apathy of the people
associated with monitoring of this drug. Such demands and studies can at
least prevent the repetition of medical tragedy of this magnitude.
1. Webpage : http://www.greenliveforever.com/tag/benfluorex accessed on
Jan 30, 2011.
2. Webpage: http://www.theheart.org/article/1154259.do accessed on Jan 30,
3. Webpage: http://www.huffingtonpost.com/2010/11/16/weight-loss-drug-
diabetes_n_784155.html accessed on Jan 30, 2011.
4. Webpage: http://thassodotcom.wordpress.com/2009/12/31/european-
in-european-union011 accessed on Jan 30, 2011.
5. Benkimoun P. French doctors demand to know why drug stayed on the
market for so long. BMJ 2010; 341:c6882.
Competing interests: Pharmacy Teaching at UG and PG level.
I agree with JD Flaysakier (1) comments regarding P Benkimoun's
article (2) : French doctors have prescribed benfluorex off-label and have
not reported adverse events. But some arguments are missing.
Obviously we can assume that French drug monitoring is deaf, dumb and
blind. As a matter of fact French administration protects domestic
pharmaceutical companies for numerous reasons that are protectionism and
lack of conflict of interest consciousness. Over the recent years no drug
was warned or withdrew from the market albeit foreign Agencies had begun.
French doctors do not declare adverse events as compared to other doctors
in equivalent countries and they are not encouraged to by governmental
agencies. In France independent authorities do not bound the medico-
pharmaco industrial complex: politics agree that what is good for industry
is good for people. Paternalism is the motto in the relationship between
doctors and patients. The last influenza pandemic crisis was typical of
French administration process: irrelevant orders falling down from the top
of the pyramid (i.e. experts ignoring disclosure forms) and bottom
eventually pertinent advices blocked as not practically sounded (i.e. GPs'
point of view). And so a very weak number of French population was
immunized against A/H1N1 virus: less than the other years when GPs were
As an example of vicious circle the French medicines agency (AFSSAPS:
Agence Fran?aise de S?curit? Sanitaire des Produits de Sant?) which is
involved and criticized in the slow process of benflorex withdrawal has a
new assistant general manager, Fabienne Bartoli, issued from high
administration (IGAS: Inspection G?n?rale des Affaires Sociales), who
defends official position regarding benfluorex history and, nevertheless,
the benfluorex enquiry ordered by French Health Ministry is entrusted to
Citizens (and doctors) have to be aware that independent agencies do not
exist in France and politics, experts, and Big Pharma preserve that Public
Health. But French doctors are also responsible for Public Health and
cannot say that they were not aware of benfluorex problems (first
publication in 1996 by a French epidemiologist -3-) even if they are
reluctant to remembering that they prescribed in and off-label 145
millions packets for 2,5 million patients: we are not often able to
believe what we know.
1. Flaysakier JD. Do French doctors really want to know about
benfluorex? BMJ 10 december 2010
2. Benkimoun P. French doctors demand to know why drug stayed on the
market so long. BMJ 341:doi:10,1136/bmj.c6682
3. Lucien Abenhaim, M.D. Et al. , Appetite-Suppressant Drugs and the Risk
of Primary Pulmonary Hypertension N Engl J Med 1996; 335:609-616August 29,
Competing interests: No competing interests
Paul Benkimoun's article title (French doctors demand to know why drug
stayed on the mar0ket for so long) is somewhat misleading.
For years many French doctors have prescribed Benfluorex at
to non diabetic
patients contrary to the restricted official indication. Furthermore,
they did it on regular prescription forms, despite the fact that they
should have used a special two-part form dedicated to patients fully
covered by the French social security system.
That means that patients using the drug as an appetite suppressant
were not supposed to get the drug reimbursed but they did get it taken in
The Benfluorex story points out the fact that many French doctors
prescribe following advice from sales reps rather than medical
It shows also that you can cheat the system as long as it is a
national company which is involved.
I am not quite sure that doctors are as eager to know as Benkimoun suggests.
They are rather expecting they will not be involved in coming trials for
out of range prescriptions.
Competing interests: No competing interests