Biomedical subjects
Silvio Garattini
Publications and source records attributed to Silvio Garattini.
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.
How can research ethics committees protect patients better?
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Varying and "atypical" indications for atypical antipsychotics.
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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 One product received a negative opinion, and five had the application withdrawn before reaching the Committee decision.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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Sparing animals and progressing in science.
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European regulatory policies on medicines and public health needs.
The establishment of the EMEA has been a revolutionary step in the European pharmaceutical system. The 15 Member States of the European Union now share a common system for the evaluation of new medicinal products entering the European market. The decisions taken apply to the whole EU, with important implications for both industry and patients who may benefit from new therapies. The main immediate consequences of this system are: i) the time and effort saved by Member States in the evaluation of new drug applications; ii) more consistent and quicker availability of medicines in EU countries; iii) the establishment of a homogeneous regulatory policy throughout the EU. Public health has been presented as the fundamental concern of the EMEA, the mission statement of which is 'to promote the protection of human health ... and of consumers of medicinal products'. However, we note that there are some inconsistencies with this objective and the current system, such as those regarding drug trial requirements and the institutional location and financing of the EMEA. In this paper, some aspects of the new system are reviewed and consideration given as to how they relate to public health needs. Proposals are made for debate alternatives and improvements to the present system that would better respond to patients' health needs.
Ethics of testing drugs with readily available alternatives.
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Fluoxetine dose and outcome in antidepressant drug trials.
OBJECTIVE: One potential for bias in the evaluation of a new drug is the dose used, both for the new compound and for the reference drug. The present study compared fluoxetine dose and outcome in trials in which fluoxetine was the experimental drug with trials in which it was the comparator. METHODS: Systematic review of randomised controlled trials comparing fluoxetine with any other antidepressant in depressive patients. Studies were allocated to one of the following two groups: group 1 = fluoxetine was the experimental drug; group 2 = fluoxetine was the control drug. Trials were located by searching the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Controlled Trials Register. RESULTS: The systematic search yielded 103 randomised trials. Studies in which fluoxetine was the experimental drug adopted a higher dose regimen than group-2 studies. In the efficacy analysis, the weighted rate of fluoxetine responders was 70.1% (confidence interval 67.4%, 72.8%) in group-1 studies and 57.9% (57.2%, 58.7%) in group-2 studies. In the effectiveness analysis, the weighted rate of fluoxetine responders was 56.4% (55.3%, 57.6%) in group-1 studies and 51.9% (51.2%, 52.7%) in group-2 studies. The weighted rate of fluoxetine dropouts was higher in group-1 studies. CONCLUSION: . Fluoxetine dose and outcome changed according to whether this drug was used as a new compound or as a reference.
Efficacy, safety, and cost of new anticancer drugs.
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Clinical databases of patients receiving antidepressants. The missing link between research and practice?
BACKGROUND: In the last 10 years the use of antidepressants has increased drastically. Unfortunately, the epidemiology of these compounds has shown significant gaps between recommendations derived from randomised controlled trials and current clinical practice. METHODS: We argue for the need to develop and maintain clinical databases of patients receiving antidepressants as a way of bridging this situation. RESULTS: In addition to experimental data generated in selected patients and settings, observational databases of large cohorts of typical patients, followed in typical settings, should be developed and maintained. Clinical databases could collect information on patient social and demographic characteristics, clinical symptoms, diagnosis and pharmacological and non-pharmacological treatments. In addition, they can provide accurate estimates of probabilities of different outcomes and on factors that affect outcome. CONCLUSION: Clinical databases should not be seen as another expensive administrative task for busy doctors. Clinical databases should be developed, organised and utilised only by clinicians who are interested in monitoring their clinical practice and want to provide patients, relatives and the public with information on prognosis and outcome in their specific context of care. Maintaining clinical databases is a routine process, nested in everyday clinical activity, which aims at constituting a permanent link between research and practice.
Italy: court's expert panel condemns tobacco.
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Independent clinical research in Europe.
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Discontinuation of Vioxx.
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The cultural shift in Italy's pharmaceutical policy in 1994: a case history.
The advent of the National Health Service in 1978 in Italy also resulted in the compilation of a formulary of pharmaceutical products to be distributed free of charge. During the subsequent years the formulary increased in size with the introduction of new drugs and consequently pharmaceutical expenses increased steadily, reaching a peak in 1992. The years preceding this peak of expenses were characterized by pervasive corruption that involved several government civil servants and even the Minister of Health, as well as several members of the national committees responsible for the approval and pricing of medicinal products. The present article summarizes the events from 1992 in Italy when the revelation of corruption in the healthcare system and the pressure of public opinion obliged the authorities to make drastic changes in the pharmaceutical policy, and also introduces and discusses the reactions and the impact of such changes on pharmaceutical expenses and drug utilization over the following years.
Ethics committees in Italy: a survey on a sample of oncologists.
AIMS AND BACKGROUND: The mission of physicians and the purpose of clinical research may give rise to a conflict between medical ethics and human rights. All the recommendations, directives and laws regarding experimental interventions require a formal protocol, approval from an ethics committee (EC), and written informed consent from potential participants. In Italy new guidelines on handling submissions to EC were published in 1998. One year later, there was a feeling among people involved in EC activities that the immediate impact of the new rules (ie, decentralization and emphasis on pharmacological aspects of the studies) was negative. A prospective study was launched to evaluate oncologists' opinions on Italian EC functioning. METHODS AND STUDY DESIGN: A questionnaire was administered twice to 110 oncologists involved in two multicenter trials. Nine questions were included regarding the following aspects: presence of an EC at hospital level, personal experience with an EC, average time required for the evaluation of proposals submitted, and level of satisfaction with important functions of the EC. RESULTS: Responses were received from 93 (first survey) and 69 (second survey) clinicians. In both surveys clinicians reported they were satisfied with the scientific and ethical aspects of EC functioning but dissatisfied with educational activities and training as well as bureaucratic and clerical requirements. At the second survey, the mean time required for evaluation after the submission of a study protocol was about 2.4 months and the level of dissatisfaction was still high for some critical aspects such as bureaucracy (44%) and educational activities and training (64%). Analysis of the change over time documented small differences (from -8% to +7%) in all aspects evaluated. CONCLUSIONS: Despite the limitations of the present study, ie, the small sample size and the intrinsic characteristics of the Italian setting, the findings add empirical evidence regarding the functioning of local EC and clinical researchers' opinions. This experience confirms that empirical studies on medical ethics are feasible and may produce useful information to facilitate the implementation of EC in the medical and lay community.
[Conflict of interests in medicine].
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