Patients beware
===============

* Joseph Erban

As reported by Laura Eggertson,1 some health care professionals foresee the need to ameliorate the drug approval mechanism in the United States and Canada. From the patient's point of view, there is also a need for a more comprehensive and transparent approach within the medical community to informing patients about the potential risks of newly released drugs.

The evidence used in Health Canada's drug approval process may be based on clinical trials or “real world” trials (or both),2 but under the current policy, patients receiving a prescription for a new drug will be unaware of the full scope of the evidence. If it consists solely of data from randomized clinical trials, then patients ought to be informed that there may be limitations in detecting unmeasured or rare adverse outcomes that might appear later in a real world setting, in observational studies or in additional clinical trials.3

The proposal by Eike-Henner Kluge that newly released drugs be given conditional licences until the outcomes of phase IV studies are known1 would ensure that health care professionals inform patients that the prescribed drug is still under review by Health Canada. Patients who decide to take the new drug (after being informed of the benefit–risk balance, the alternative options and their effectiveness, costs and uncertainties) should then be monitored for adverse effects and any such adverse outcomes reported to appropriately designated authorities.

From an ethical point of view, there are similarities between patients who participate in randomized controlled studies and those who participate in real world trials, since in both types of studies, drug efficacy and safety are still under review. Therefore, it seems to me that the ethical guidelines currently applied for the first group should also be applied to consumers of medications prescribed under conditional licences.4

## Footnotes

*   The opinions expressed here are solely those of the author and do not represent the views of the Clinical Ethics Committee or the Sir Mortimer B. Davis – Jewish General Hospital.

## References

1.  1. Eggertson L. Drug approval system questioned in US and Canada. CMAJ 2005;172(3):317-8.
    
    [FREE Full Text](http://www.cmaj.ca/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czo5OiIxNzIvMy8zMTciO3M6NDoiYXRvbSI7czoyMjoiL2NtYWovMTczLzUvNDY1LjMuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9) 

2.  2. Laupacis A, Paterson JM, Mamdani M, Rostom A, Anderson GM. Gaps in the evaluation and monitoring of new pharmaceuticals: proposal for a different approach [editorial]. CMAJ 2003;169(11):1167-70.
    
    [FREE Full Text](http://www.cmaj.ca/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czoxMToiMTY5LzExLzExNjciO3M6NDoiYXRvbSI7czoyMjoiL2NtYWovMTczLzUvNDY1LjMuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9) 

3.  3. Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004;364:2021-9.
    
    [CrossRef](http://www.cmaj.ca/lookup/external-ref?access_num=10.1016/S0140-6736(04)17514-4&link_type=DOI) 
    
    [PubMed](http://www.cmaj.ca/lookup/external-ref?access_num=15582059&link_type=MED&atom=%2Fcmaj%2F173%2F5%2F465.3.atom) 
    
    [Web of Science](http://www.cmaj.ca/lookup/external-ref?access_num=000225495700025&link_type=ISI) 

4.  4. Tri-Council policy statement. *Ethical conduct for research involving humans.* Ottawa: Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities research Council of Canada; 2003 Jun. Available: [www.pre.ethics.gc.ca/english/pdf/TCPSJune2003\_E.pdf](http://www.pre.ethics.gc.ca/english/pdf/TCPSJune2003_E.pdf) (accessed 2005 Jun 2).