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

* Charles Weijer

The point of my commentary1 is simple: Canada's regulatory system for the protection of research subjects is broken and needs to be fixed. Proof of this failure is found in the approval by 19 out of 20 research ethics boards (REBs) of a placebo-controlled trial that clearly violates article 7.4 of the *Tri-Council Policy Statement* and paragraph 29 of the *Declaration of Helsinki*.2,3 Effective regulation of research requires change at a variety of levels, including the researcher, institution, funding councils, and Health Canada. It is not surprising that a strong emotional response has been evoked in the letters to the editor. When something is broken, some will continue to insist — however implausibly — that it is working just fine.

Grenier claims that I have not provided sufficient information to determine if the trial in question falls into one of the exemptions laid out in article 7.4. This is not the case. I invite readers to compare the text of my article with article 7.4a-g. This protocol qualifies for none of the listed exemptions.

Corman and colleagues are correct that university and hospital REBs are subject to conflicts of interest because their institutions receive money to conduct research, and researchers often dominate REBs. This is yet another aspect of the current system that needs to be fixed. In 1993, Paul McNeil proposed that REBs ought to be composed of equal numbers of community and institutional representatives, and the REB chair must be a community member.4 The problem with for-profit REBs cannot, however, be fixed. The REB is a social oversight mechanism charged with the public's trust to protect research subjects. This trust will surely be eroded when the regulatory system contains elements that exist to turn ethics reviews into profit. Corman and colleagues helpfully provide other examples supporting my point that Canada's research regulatory system is broken.

Buchanan reasonably asks whether a placebo given in the context of a modern clinical trial is really a placebo because research participants are informed that they may receive a placebo. A fascinating literature is available on so-called revealed placebo use in medical practice.5 It is unclear that deception is key to achieving a placebo effect. In any case, placebo use in clinical trials is not fully revealed because subjects are only informed that they *may* receive a placebo, not that they *will* receive one.

**Charles Weijer** Department of Bioethics Dalhousie University Halifax, NS

## 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/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czo5OiIxNjYvNS82MDMiO3M6NDoiYXRvbSI7czoyMjoiL2NtYWovMTY3LzUvNDU2LjIuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9) 

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](http://www.nserc.ca/programs/ethics/english/policy.htm) (accessed 2002 July 12).
    
    

3.  3. World Medical Association. *Declaration of Helsinki*. 2000. Available: [www.wma.net/e/policy/17-c\_e.html](http://www.wma.net/e/policy/17-c_e.html) (accessed 2002 June 4).
    
    

4.  4. McNeil PM. *The ethics and politics of human experimentation.* Cambridge: Cambridge University Press; 1993. p. 219.
    
    

5.  5. Dinnerstein AJ, Haim J. Modification of placebo effects by means of drugs. J Abnorm Sociol Psychol 1970; 75:308-14. 
    
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