E-drug: ISDB Declaration on Therapeutic Advance in Use of Medicines
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PRESS RELEASE
INTERNATIONAL SOCIETY OF DRUG BULLETINS (ISDB)
PARIS, 16 NOVEMBER 2001
THE INTERNATIONAL SOCIETY OF DRUG BULLETINS (ISDB) DEFINES WHAT IS A TRULY
INNOVATIVE DRUG
The pharmaceutical industry is deliberately blurring the distinction
between the few drugs that represent a real therapeutic advance for
patients, and the numerous technical or commercial novelties that provide
no extra benefit.
The International Society of Drug Bulletins (ISDB) is a forum for over 80
therapeutic journals for doctors, pharmacists, and patients worldwide.
Member journals are independent of the pharmaceutical industry.
ISDB journals play an important role, helping health professionals to
compare newly released and existing drugs.
ISDB journals directly concerned with the assessment of new drugs met,
together with international experts, in Paris on 15 and 16 November 2001,
to draw up a joint declaration on exactly what features a new drug must
have to be considered as a real therapeutic advance.
The ISDB Declaration on Therapeutic Advance states that a new substance, or
a new use of an existing drug, only represents a real advance when patients
draw a supplementary benefit relative to previous treatments.
Therapeutic advance can be provided in three ways: better efficacy; fewer
adverse effects; better convenience to patients.
The current saturation of the market by novelties that do not improve
patients' conditions, and the lack of new drugs to meet outstanding needs,
are due to the same reasons.
Health policy makers and drug regulatory agencies are too compliant: they
do not require the pharmaceutical industry to compare new products with
existing treatments, and authorize "new" drugs that have no advantages over
existing products.
Public funding of biomedical research is inadequate to develop drugs for
conditions without effective treatments. ISDB criticizes the lack of
transparency in drugs agencies' decisions. Health professionals are
deprived of crucial information, preventing them from using drugs based on
full knowledge of comparative efficacy and safety.
The ISDB declaration is available on request from the President, Christophe
Kopp.
E-mail: christophe.kopp@wanadoo.fr
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