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Theme: Therapeutic progress

New products or techniques are only worthwhile if they translate into better care for patients. Clinical data may mean little in terms of improving patients’ health, and lives. How can we know genuine progress when we see it? 

ISDB declaration: what is an innovative drug?

The joint declaration issued by the International Society of Drug Bulletins (ISDB) defines exactly what features a new drug must have to be considered as a real therapeutic advance. Therapeutic advance can be provided in three ways: better efficacy; fewer adverse effects; better convenience to patients.

PRESS RELEASE
INTERNATIONAL SOCIETY OF DRUG BULLETINS

Paris, 16 November 2001

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 in the Use of Medicines 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 (see the Declaration in the off-print enclosed).

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.

©Prescrire 2002

Prescrire Int 2002; 11 (57): 31.
More information:
 
Declaration on
therapeutic advance
in the use of medicines
ISDB 2001