Biomedical subjects
Vittorio Bertele'
Publications and source records attributed to Vittorio Bertele'.
The impact of European regulatory policies on psychotropic drug prescribing patterns.
Thanks to their alleged better tolerability atypical or second-generation antipsychotic drugs (SGA) have gained a considerable fraction of the market at the expense of the classical antipsychotics. The massive advertising of SGA focussed the doubtful reduction of extra-pyramidal side effects (EPS) overlooking the information about the cardiovascular risk induced by SGA. This also led to extensive off-label use as the control of behavioural symptoms associated with dementia in elderly patients. Although the European Medicine Agency (EMEA) eventually warned physicians and patients of the risk associated with SGA use in this area, the regulatory system has some responsibility in this situation. No added therapeutic value is required for new drugs to be approved for the market. They are only evaluated for their own quality, efficacy and safety with no comparison with available alternative treatments. This implies that new drugs may, in fact, be potentially less effective or less safe than other drugs currently in use.
European Council waters down European Parliament's drug-regulatory legislation.
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Efficacy, safety and cost of new cardiovascular drugs: a survey.
To assess the type and degree of innovation of the cardiovascular drugs centrally approved in the European Union between 1995 and 2002. Sources of information were the European Public Assessment Reports and the Summaries of Product Characteristics published by the European Medicines Evaluation Agency. The Agency approved 11 active substances belonging to 5 therapeutic classes: anti-hypertensives, anti-arrhythmics, anti-platelets, anti-coagulants and fibrinolytics. Analysis of the documentation on which the marketing authorization was based shows few elements of innovation. Moreover, the new drugs usually cost more than similar drugs already available. Cardiovascular drugs approved in Europe in the last few years have contributed little to progress in this area. These approvals provide no real advantage to patients and lay an economic burden on society.
Efficacy, safety and cost of new drugs acting on the central nervous system.
OBJECTIVE: To examine the degree of innovation of the products with indications for CNS diseases approved for the European market through the centralized procedure. METHODS: This paper examines the documentation available on nine products approved by the European Medicines Evaluation Agency in its first years of activity. RESULTS: The Committee for Proprietary Medicinal Products approved only five products by consensus (levacetylmethadol, levetiracetam, olanzapine, pramipexole, riluzole). Four were approved by majority (entacapone, memantine, rivastigmine, zaleplon). One product received a negative opinion, and five had the application withdrawn before reaching the Committee decision. CONCLUSIONS: An analysis of the efficacy and safety profile of these products indicates that few minor therapeutic advances have been achieved in this area. Most approved products cover needs already met, at higher cost, without substantial improvement.
Light and shade in proposed revision of EU drug-regulatory legislation.
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A critique to the European regulatory system.
The establishment of the European Medicines Evaluation Agency (EMEA) has resulted in 15 states of the European Union (EU) sharing a common system for the evaluation of new medicinal products, with important implications for both industry and patients including (1) the time and effort saved by member states in the evaluation of new drug applications; (2) more consistent and quicker availability of medicines in EU countries; and (3) the establishment of a homogeneous regulatory policy throughout the EU. However, there are some inconsistencies between the EMEA objective "to promote the protection of human health" (Council Regulation, 1993) and the current system. This article reviews the organization and procedures of the EMEA and makes some proposals for substantial modifications to the present system.