Placebo tribulations
====================

* Glenn G. Grenier

Charles Weijer's1 recent indictment of the Canadian research review process is unsupported. On the basis of the meagre information given, it is impossible to determine whether the protocol in question violates the *Tri-Council Policy Statement* (TCPS).2 That guideline enunciates a strong presumption against placebo use when “standard therapies” are available. It does not state an exceptionless rule, and, indeed, the policy discusses some of the exceptions. Demonstrating that the protocol violates the TCPS statement is crucial to Weijer's accusation that Canadian researchers, research ethics boards (REBs), universities and federal funding agencies are shirking their responsibilities.

Health Canada cannot dictate decisions on particular cases to REBs, but nothing is wrong with it promulgating general policy on research ethics. The passage Weijer quotes contains nothing but statements of general principles. Not a single one of them is objectionable, idiosyncratic or even at odds with the TCPS statement. I know of no national or international guideline that specifies that the judicious use of placebo controls in clinical trials is unethical. (There is, of course, great controversy over what counts as a judicious use.) Benjamin Freedman agreed with the TCPS that REBs should reject trials with inconclusive designs.3

**Glenn G. Grenier** Department of Philosophy University of Alberta Edmonton, Alta.

## References

1.  1. Weijer C. Placebo trials and tribulations [editorial]. CMAJ 2002;166(5):603-4.
    
    [FREE Full Text](http://www.cmaj.ca/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czo5OiIxNjYvNS82MDMiO3M6NDoiYXRvbSI7czoyMjoiL2NtYWovMTY3LzUvNDU1LjEuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9) 

2.  2. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. *Tri-council policy statement: ethical conduct for research involving humans*. 1998 [updated 2000 Nov 21]. Available: www . nserc .ca/programs/ethics/english/policy.htm (accessed 2002 July 12).
    
    

3.  3. Freedman B. Placebo-controlled trials and the logic of clinical purpose. IRB 1990;12(6):1-6. 
    
    [PubMed](http://www.cmaj.ca/lookup/external-ref?access_num=11651387&link_type=MED&atom=%2Fcmaj%2F167%2F5%2F455.1.atom)