Healthy Skepticism Library item: 15385

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Tremblay M.
Commentary: Risks of doing as the Romans do.
BMJ 2009 Mar 31; 338:b1107:
http://www.bmj.com/cgi/content/extract/338/mar31_3/b1107

Abstract:

Garattini and Chalmers (doi:10.1136/bmj.b1025) make four suggestions to improve the evaluation of drugs-involve patients in establishing research priorities, improve the transparency of drug evaluations and studies, fund independent drug evaluations, and require evidence that new drugs have added clinical value. Although controversial, many of their proposals would benefit patients. However, their suggestion to follow the Italian approach to funding independent clinical trials is unlikely to be a good idea.

In 2003, Italy decided to establish a tax on the drug industry of 5% of their medicines advertising budget. This money is used by the state medicines agency, AIFA, to fund clinical research on the efficacy of orphan drugs, comparisons of drugs for the same indication, observational outcome studies, and pharmacovigilance.1 2

We know that there are real problems with clinical trials as currently conducted, such as the use of surrogate end points, weak information on long term efficacy, and . . .