Silvio Garattini

Summary

Affiliation: Istituto di Ricerche Farmacologiche Mario Negri
Country: Italy

Publications

  1. ncbi request reprint Placebo? no thanks, it might be bad for me!
    Silvio Garattini
    Istituto di Ricerche Farmacologiche Mario Negri, Via Giuseppe La Masa 19, 20156 Milan, Italy
    Eur J Clin Pharmacol 69:711-4. 2013
  2. doi request reprint Evaluation of benefit-risk
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Pharmacoeconomics 28:981-6. 2010
  3. doi request reprint Orphan drugs, orphan diseases. The first decade of orphan drug legislation in the EU
    Roberta Joppi
    Laboratory of Drug Regulatory Policies, Mario Negri Institute for Pharmacological Research, via Giuseppe La Masa, 19, 20156 Milan, Italy
    Eur J Clin Pharmacol 69:1009-24. 2013
  4. ncbi request reprint Haematological anticancer drugs in Europe: any added value at the time of approval?
    Vittorio Bertele'
    Laboratory of Regulatory Policies, Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milan, Italy
    Eur J Clin Pharmacol 63:713-9. 2007
  5. ncbi request reprint Do we learn the right things from clinical trials?
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Eur J Clin Pharmacol 64:115-25. 2008
  6. doi request reprint Ethics in clinical research
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Via G La Masa 19, 20156 Milan, Italy
    J Hepatol 51:792-7. 2009
  7. doi request reprint Limits of add-on trials: antirheumatic drugs
    Laura Ottolenghi
    Laboratory of Regulatory Policies, Mario Negri Institute for Pharmacological Research, Via Giuseppe La Masa 19, 20156 Milan, Italy
    Eur J Clin Pharmacol 65:33-41. 2009
  8. pmc Orphan drug development is progressing too slowly
    Roberta Joppi
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Br J Clin Pharmacol 61:355-60. 2006
  9. pmc How can we regulate medicines better?
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milano, Italy
    BMJ 335:803-5. 2007
  10. ncbi request reprint The impact of European regulatory policies on psychotropic drug prescribing patterns
    Silvio Garattini
    Istituto di Richerche Farmacologiche Mario Negri, Milan, Italy
    Int Rev Psychiatry 17:199-204. 2005

Collaborators

Detail Information

Publications40

  1. ncbi request reprint Placebo? no thanks, it might be bad for me!
    Silvio Garattini
    Istituto di Ricerche Farmacologiche Mario Negri, Via Giuseppe La Masa 19, 20156 Milan, Italy
    Eur J Clin Pharmacol 69:711-4. 2013
    ..To assess the potential damage to patients from the inappropriate use of placebo...
  2. doi request reprint Evaluation of benefit-risk
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Pharmacoeconomics 28:981-6. 2010
    ..It is also not clear which is the most appropriate model to calculate QALYs for clinical purposes and how it can be used as a predictive tool at the individual level...
  3. doi request reprint Orphan drugs, orphan diseases. The first decade of orphan drug legislation in the EU
    Roberta Joppi
    Laboratory of Drug Regulatory Policies, Mario Negri Institute for Pharmacological Research, via Giuseppe La Masa, 19, 20156 Milan, Italy
    Eur J Clin Pharmacol 69:1009-24. 2013
    ..To assess the methodological quality of Orphan Medicinal Product (OMP) dossiers and discuss possible reasons for the small number of products licensed...
  4. ncbi request reprint Haematological anticancer drugs in Europe: any added value at the time of approval?
    Vittorio Bertele'
    Laboratory of Regulatory Policies, Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milan, Italy
    Eur J Clin Pharmacol 63:713-9. 2007
    ....
  5. ncbi request reprint Do we learn the right things from clinical trials?
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Eur J Clin Pharmacol 64:115-25. 2008
  6. doi request reprint Ethics in clinical research
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Via G La Masa 19, 20156 Milan, Italy
    J Hepatol 51:792-7. 2009
    ..The current legislative and regulatory setting seems designed to meet commercial interests rather than public health needs...
  7. doi request reprint Limits of add-on trials: antirheumatic drugs
    Laura Ottolenghi
    Laboratory of Regulatory Policies, Mario Negri Institute for Pharmacological Research, Via Giuseppe La Masa 19, 20156 Milan, Italy
    Eur J Clin Pharmacol 65:33-41. 2009
    ..This paper assesses the design of clinical studies used in the process of regulatory approval, focusing on how add-on studies affect regulatory decisions...
  8. pmc Orphan drug development is progressing too slowly
    Roberta Joppi
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Br J Clin Pharmacol 61:355-60. 2006
    ..To assess the methodological quality of OMP dossiers and to discuss possible reasons for the small number of products licensed...
  9. pmc How can we regulate medicines better?
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milano, Italy
    BMJ 335:803-5. 2007
  10. ncbi request reprint The impact of European regulatory policies on psychotropic drug prescribing patterns
    Silvio Garattini
    Istituto di Richerche Farmacologiche Mario Negri, Milan, Italy
    Int Rev Psychiatry 17:199-204. 2005
    ..This implies that new drugs may, in fact, be potentially less effective or less safe than other drugs currently in use...
  11. ncbi request reprint Having your cake and eating it: office of fair trading proposal for funding new drugs to benefit patients and innovative companies
    Brian Godman
    Pharmacology Research Institute Mario Negri, Milan, Italy
    Pharmacoeconomics 26:91-8. 2008
    ..The majority of these suggestions are not in the best interests of patients or innovative pharmaceutical companies seeking to reap the rewards of their efforts...
  12. ncbi request reprint Pharmacokinetics in cancer chemotherapy
    Silvio Garattini
    Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157 Milano, Italy
    Eur J Cancer 43:271-82. 2007
  13. ncbi request reprint A double-blind, placebo-controlled, randomized trial of bupropion for smoking cessation in primary care
    Roldano Fossati
    Department of Oncology, Mario Negri Institute, Eritrea 62, Milan 20157, Italy
    Arch Intern Med 167:1791-7. 2007
    ..To assess whether these results are applicable in primary care, we launched a double-blind, placebo-controlled, randomized trial to be conducted by general practitioners...
  14. ncbi request reprint Clinical databases of patients receiving antidepressants. The missing link between research and practice?
    Corrado Barbui
    Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157, Milano, Italy
    J Affect Disord 70:191-6. 2002
    ..Unfortunately, the epidemiology of these compounds has shown significant gaps between recommendations derived from randomised controlled trials and current clinical practice...
  15. ncbi request reprint Designing the most favourable study design
    Silvio Garattini
    Instituto Mario Negri, Via Eritrea, 62, 20157 Milano, Italy
    Eur J Clin Pharmacol 61:85-6. 2005
  16. ncbi request reprint Independent clinical research in Europe
    Giuseppe Remuzzi
    Mario Negri Institute for Pharmacological Research, Bergamo and Milan, Italy
    Lancet 364:1723-6. 2004
  17. pmc How can research ethics committees protect patients better?
    Silvio Garattini
    Mario Negri Institute, Via Eritrea 62, 20157 Milan, Italy
    BMJ 326:1199-201. 2003
  18. ncbi request reprint Ethics committees in Italy: a survey on a sample of oncologists
    Paola Mosconi
    Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
    Tumori 89:189-92. 2003
    ..A prospective study was launched to evaluate oncologists' opinions on Italian EC functioning...
  19. ncbi request reprint Light and shade in proposed revision of EU drug-regulatory legislation
    Silvio Garattini
    Istituto di Ricerche Farmacologiche Mario Negri, 20157, Milan, Italy
    Lancet 361:635-6. 2003
  20. ncbi request reprint Efficacy, safety and cost of new cardiovascular drugs: a survey
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milan, Italy
    Eur J Clin Pharmacol 59:701-6. 2003
    ..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...
  21. ncbi request reprint Efficacy, safety and cost of new drugs acting on the central nervous system
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157, Milan, Italy
    Eur J Clin Pharmacol 59:79-84. 2003
    ..To examine the degree of innovation of the products with indications for CNS diseases approved for the European market through the centralized procedure...
  22. pmc Efficacy, safety, and cost of new anticancer drugs
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, 20157 Milan, Italy
    BMJ 325:269-71. 2002
  23. ncbi request reprint European regulatory policies on medicines and public health needs
    Luca Li Bassi
    Laboratory Regulatory Policies, Mario Negri Institute for Pharmacological Research, Milano, Italy
    Eur J Public Health 13:246-51. 2003
    ..Proposals are made for debate alternatives and improvements to the present system that would better respond to patients' health needs...
  24. ncbi request reprint European Council waters down European Parliament's drug-regulatory legislation
    Silvio Garattini
    Istituto di Ricerche Farmacologiche Mario Negri, 20157, Milan, Italy
    Lancet 362:1688-9. 2003
  25. ncbi request reprint The cultural shift in Italy's pharmaceutical policy in 1994: a case history
    Silvio Garattini
    Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
    J Ambul Care Manage 27:120-6. 2004
    ....
  26. ncbi request reprint Role of presynaptic alpha2-adrenoceptors in antidepressant action: recent findings from microdialysis studies
    Roberto W Invernizzi
    Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157 Milano, Italy
    Prog Neuropsychopharmacol Biol Psychiatry 28:819-27. 2004
    ..Finally, they suggest that co-administration of an alpha(2)-adrenoceptor antagonist may improve the therapeutic effect of NRI...
  27. ncbi request reprint Efficacy and safety of immunosuppressive drugs approved in EU through the centralised procedure
    Vittorio Bertele'
    Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milano, Italy
    Eur J Clin Pharmacol 63:707-12. 2007
    ..The aim of the present work is to evaluate the efficacy and safety data used by the European Medicines Agency (EMEA) between 1995 and June 2006 to approve new immunosuppressive drugs with indications in solid organ transplantation...
  28. ncbi request reprint New antirheumatic drugs: any real added value? A critical overview of regulatory criteria for their marketing approval
    Vittorio Bertele'
    Laboratory of Regulatory Policies, Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157, Milan, Italy
    Eur J Clin Pharmacol 63:879-89. 2007
    ..The aim of this paper is to summarize and critically evaluate the type of studies and clinical endpoints accepted by the European Medicines Agency (EMEA) to approve these new drugs...
  29. ncbi request reprint Predicting the clinical relevance of drug interactions from pre-approval studies
    Silvio Caccia
    Laboratory of Drug Metabolism, Mario Negri Institute for Pharmacological Research, Milan, Italy
    Drug Saf 32:1017-39. 2009
    ....
  30. ncbi request reprint Rare diseases: what's next?
    Giuseppe Remuzzi
    Clinical Research Centre for Rare Diseases Aldo e Cele Dacco, Mario Negri Institute for Pharmacological Research, Laboratori Negri Bergamo, 24125 Bergamo, Italy
    Lancet 371:1978-9. 2008
  31. ncbi request reprint Fluoxetine dose and outcome in antidepressant drug trials
    Corrado Barbui
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Eur J Clin Pharmacol 58:379-86. 2002
    ..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...
  32. doi request reprint Clinical trial registries: from an omen to a common and disclosed practice
    Chiara Pandolfini
    Department of Public Health, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Via Giuseppe La Masa 19, 20156 Milan, Italy
    Eur J Clin Pharmacol 69:1725-6. 2013
    ..The role of registries in also increasing transparency is fundamental, and these databases could be contemplated by research organizations, even at more local levels...
  33. ncbi request reprint Non-inferiority trials are unethical because they disregard patients' interests
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Lancet 370:1875-7. 2007
  34. pmc Thrombolysis or nothing for acute myocardial infarction? It's all the same!
    Vittorio Bertele'
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Br J Clin Pharmacol 65:955-8. 2008
    ..The methodological and ethical value of equivalence and non-inferiority trials is questioned. These studies are still increasingly used in drug evaluation and accepted by the scientific community and the regulatory authorities...
  35. ncbi request reprint Long-chain n-3 fatty acids in lipid rafts: implications for anti-inflammatory effects
    Silvio Garattini
    Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
    J Cardiovasc Med (Hagerstown) 8:S30-3. 2007
    ..By altering the lipid composition of the membrane microdomains, n-3 fatty acids have the potential to modulate these signalling events and exert anti-inflammatory actions...
  36. pmc Patient organizations' funding from pharmaceutical companies: is disclosure clear, complete and accessible to the public? An Italian survey
    Cinzia Colombo
    Laboratory of Medical Research on Consumer Involvement, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy
    PLoS ONE 7:e34974. 2012
    ..This survey aims to assess the transparency of a large group of Italian patient and consumer groups and a group of pharmaceutical companies, focusing on their websites...
  37. pmc Risk:benefit assessment of old medicines
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Milan, Italy
    Br J Clin Pharmacol 58:581-6. 2004
    ..This brief discussion reviews these questions and gives some examples by comparing diuretics and new antihypertensive agents, ticlopidine and clopidogrel, and atypical and classical antipsychotic agents...
  38. ncbi request reprint Smoking in Italy 2005-2006: effects of a comprehensive National Tobacco Regulation
    Silvano Gallus
    Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157 Milan, Italy
    Prev Med 45:198-201. 2007
    ..On 10 January 2005 Italy became the first large European country adopting a comprehensive smoke-free legislation. We provide information on smoking prevalence in Italy and evaluate the effects of the 2005 regulations...
  39. ncbi request reprint Fish oil and mental health: the role of n-3 long-chain polyunsaturated fatty acids in cognitive development and neurological disorders
    Alessandro Assisi
    Regulatory Policies Laboratory, Mario Negri Institute for Pharmacological Research, Milan, Italy
    Int Clin Psychopharmacol 21:319-36. 2006
    ....
  40. pmc Disappointing biotech
    Roberta Joppi
    Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milan, Italy
    BMJ 331:895-7. 2005