Il doppio standard
Ovvero esistono troppe differenze tra pratica clinica e clinical trials?
V. Basevi, N. Magrini Bologna, 14.02.2014
Il medico in base al suo codice etico deve sempre agire nell’interesse del paziente.
l’esistenza di rischi e l’incertezza del beneficio per i partecipanti a uno studio clinico può confliggere con il dovere primario del clinico
è quindi fondamentale che chi partecipa alla ricerca venga
informato/comprenda che il partecipare a quello studio produrrà una conoscenza per tutti, non un vantaggio per il singolo
la sottile differenza fra:
− partecipare a un RCT in cui il nuovo trattamento è confrontato con lo standard (la terapia non standard è valutata)
− essere sottoposti a un trattamento off label (la terapia
− non standard è usata) Editors. PLoS Med 2007;4:e340
?
Doyal L, Tobias JS eds. Informed consent in medical research. BMJ books 2001
Lancet 2004;364:1321-28
CRASH. Lancet 2004;364:1321-28
Lancet Volume 364, Issue 9442, 9–15 October 2004
Double standards on informed consent to
treatments that are already in use within ‘normal’ clinical practice
“I need permission to give a drug to half of my patients, but not to give it to them all. ”
Richard Smithells, 1975
“The clinician who is convinced that a certain treatment works will almost never find an ethicist in his path,
whereas his colleague who wonders and doubts and wants to learn will stumble over piles of them.”
Editorial. Lancet 1990
A single standard for informed consent to treatment would require all patients to be told the rationale for selecting the treatments offered to them.
“I was told at medical school thirty years ago that this treatment was the best available ”
“This drug was highly recommended at a sponsored symposium in Tenerife last month”
“The more of these operations I do, the more I earn”
“My institution has a massive grant from the company that makes this equipment”
“I have shares in the company that makes this drug”
12 Fuchs VR. N Engl J Med 2011;365:585-7
