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Placebo-Controlled trials

This letter from Prescrire to the Editor of Health Affairs, in response to "Decline in Placebo-controlled trial results suggests new directions for comparative effectiveness research" (Health Affairs, June 2013), was published in their October 2013 issue. In its letter, Prescrire argues that a drug approval system based on placebo-controlled trials does not encourage real therapeutic progress. Quite the contrary, it opens the door to therapeutic regression.

The research by Mark Olfson and Steven Marcus (Jun 2013) sheds light on an issue that my colleagues and I at Prescrire have been addressing for the last thirty-two years. Since its inception in 1981, Prescrire has conducted reviews on all new drug products and indications entering the European Union, and France in particular. Our independent appraisal of the evidence assesses the added therapeutic value of each new medicine or indication (1).  We help health professionals (and, ultimately, patients) distinguish real therapeutic advances (those with better efficacy, fewer side effects, or greater convenience) from mere commercial novelties.

We have compared the clinical evidence available at marketing approval for 2000–01 to that for 2010–11. The number of marketing applications including at least one trial comparing the new drug to a reference treatment (the best proven intervention) decreased significantly, from 60 applications out of 80 in 2000–01 to 51 out of 101 in 2010–11.

A drug approval system based on placebo-controlled trials does not encourage real therapeutic progress. Quite the contrary, it opens the door to therapeutic regression. Public health and patient safety can be upheld only when new drugs are compared to reference treatments and are proved to be better than what is available, before being recommended by health care professionals (and payers) and used by patients.

These results further underscore the need for regulatory agencies to adopt therapeutic advance as a key criterion during the marketing approval process.

Toussaint B "Placebo-Controlled Trials" Health Affairs 2013; 32 (10): 1858-1859.

> Read this response online at healthaffairs.org
 

TABLE 1. NUMBER OF NEW DRUGS/INDICATIONS REVIEWED BY PRESCRIRE
COMPARISON BETWEEN 2000 - 2001 AND 2010 - 2011
NEW DRUGS OR INDICATIONS 2000 to 2001
N=179		 2010 to 2011
N=189
INDICATIONS WITH EXISTING REFERENCE TREATMENTS 80 (45%) 101 (53%)
DRUG EVALUATION DOSSIER CONTAINED:
At least one trial vs. reference treatment 60 (75%) 51 (50%)
Only placebo-controlled trials 16 (20%) 33 (33%)
Only trials against comparator with less favourable harm-benefit ratio than reference treatment 1 (1.25%) 8 (8%)
Only non-comparative trials 3 (3.75%) 9 (9%)

©Prescrire1 December 2013

Note:
1 - Prescrire “How we work: Prescrire's complex, collective editing process has been fine-tuned over the years”. April 2009.
Available at: http://english.prescrire.org/en/82/170/0/0/About.aspx
Accessed 26 June 2013. > Click here
Read this response
online at healthaffairs.org

For more information:

How we work:
Prescrire's complex,
collective editing process
has been fine-tuned
over the years
Free

New drugs and
indications in 2012
(January 2013)
Free

New drugs and indications
in 2012. Sluggish progress,
timid measures to
protect patients
Prescrire Int 2013;
22 (137): 105-107.
Pdf, free