[Ip-health] The variables in Dr. Peter Bach's Drug Abacus

Joel Lexchin jlexchin at yorku.ca
Fri Jun 19 13:29:04 PDT 2015


Jamie:

I have to agree with Ruth. Novelty is only valuable if it leads to better therapeutic outcomes. The glitazones - rosiglitazone (Avandia) and pioglitazone (Actos) work through a novel mechanism and are public health disasters. The drugs that you cite worked through novel mechanisms but had public health benefits. Usually by the end of a phase III trial you know how efficacious the drug will be although safety is often only really determined after the drug is on the market and large numbers of people have used it. Larger number of people in clinical trials may be a proxy for R&D costs but it’s also a proxy for drugs having less additional therapeutic benefit over what’s already on the market. One of the reasons for large clinical trials is the need to achieve statistical significance - the larger the trial the easier it is to get a p value less than 0.05. If a drug is really valuable then you don’t need large number of patients to show it. (This argument doesn’t apply to trials on drugs for rare diseases because in these cases small trials are the norm.)

Joel
--
Joel Lexchin MD
Professor 
School of Health Policy and Management
Faculty of Health
York University
4700 Keele St. 
Toronto ON 
Canada M3J 1P3
Tel:		+416-736-2100 x 22119
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E mail:	jlexchin at yorku.ca	





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