Healthy Skepticism Library item: 10558

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Balakrishnan K, Tordoff J, Norris P, Reith D.
Establishing a baseline for the monitoring of medicines availability for children in the UK: 1998-2002.
Br J Clin Pharmacol 2007 Jan; 63:(1):85-91
http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-2125.2006.02729.x

Abstract:

AIM: To determine changes in the availability, in terms of licensing and formulations, of medicines for children in the UK between 1998 and 2002.

METHODS: Using the Association of British Pharmaceutical Industry (ABPI) Compendium of Data Sheets and Summaries of Product Characteristics (SPC) 1998 and the Medicines Compendium 2002, licensed medicines available in the UK in the calendar years 1998 and 2002 were examined.

RESULTS: In 1998, 61% of chemical entities/fixed-dose combinations were licensed in some form for children compared with 64% in 2002. Of the chemical entities/fixed-dose combinations with oral formulations, 250 (33%) in 1998 had an oral formulation suitable for use by children and in 2002 there were 284 (34%). Of the 129 new chemical entities registered in the UK between 1998 and 2002, only 30 (23%) were licensed for under the age of 12 years and 19 (15%) for the neonatal age group. A total of 480 medicines licensed for children were withdrawn from marketing but only cisapride and primidone had no generic or therapeutic alternatives.

CONCLUSION: Although there was improvement in the availability of medicines for children in the UK over the 5-year period (1998-2002), considerable inequities still existed between children and adults.

Keywords:
MeSH Terms: Child Child, Preschool Drug Approval/statistics & numerical data* Drug Therapy/trends* Great Britain Humans Infant Legislation, Drug Pediatrics/trends* Pharmaceutical Preparations/supply & distribution* Substances: Pharmaceutical Preparations

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909