title: Placebo? no thanks, it might be bad for me!
abstract: OBJECTIVE
  To assess the potential damage to patients from the inappropriate use of placebo.
  
  
  METHODS
  Pivotal clinical trials of new drugs were evaluated for the treatment of multiple sclerosis following effective treatment with beta interferons and glatiramer acetate. The differences in the relapse rate between the experimental arms of the trials with interferons and glatiramer and the placebo groups were calculated.
  
  
  RESULTS
  In ten pivotal trials, 2,752 patients were given placebo instead of the best proven treatments. The annualized relapse rate was reported for 2,405 of these patients. Patients receiving placebo suffered 630 more relapses than those treated with interferons or glatiramer.
  
  
  CONCLUSIONS
  The inappropriate use of placebo in clinical trials unduly harms patients. The use of standard active comparators would preserve patients' rights and better define the respective clinical value of new medicines.
authors.affiliation: Istituto di Ricerche Farmacologiche Mario Negri, Via Giuseppe La Masa 19, 20156 Milan, Italy. silvio.garattini@marionegri.it
authors.forename: Silvio
authors.initials: S
authors.lastname: Garattini
authors.forename: Vittorio
authors.initials: V
authors.lastname: Bertelé
authors.forename: Rita
authors.initials: R
authors.lastname: Banzi
mesh_terms: D018450:Disease Progression; D000068717:Glatiramer Acetate; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D016899:Interferon-beta / Q000627:therapeutic use; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000188:drug therapy; D061214:Patient Safety; D010455:Peptides / Q000627:therapeutic use; D010919:Placebos / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012008:Recurrence; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D007155:Immunologic Factors; D010455:Peptides; D010919:Placebos; D000068717:Glatiramer Acetate; D016899:Interferon-beta