Marching to Different Drummers: Health Advocacy Groups in Canada and Funding from the Pharmaceutical Industry

By Sharon Batt
January 2005

I. Introduction

Notes

1 A more accurate term would be “post-approval”, or “post-licensing”. The term “post-market” has been used throughout this paper as it is the commonly used terminology.

2 Efficacy refers to data obtained under ideal conditions, as in a clinical trial when variables are held under control and subjects are selected. Effectiveness, on the other hand, refers to a real world situation, where a variety of uncontrolled factors may intervene, for example: people simultaneously taking other medications or having other medical conditions, people not always following dosage instructions correctly or forgetting to take all of their pills, etc.

3 Health Canada effectively recognizes this “experimental” status in that it considers an “unusual failure in efficacy” of a drug as an adverse reaction and requires manufacturers to report all of these cases as long as a drug is considered “new”, which for the purposes of this requirement is a minimum of seven years after it has first been marketed in Canada.

4 In 2003, the Canadian government committed $190 million to be spent over a 5-year period to improve drug regulatory systems. Of the $40 million earmarked for year one, only $2.5 million was allocated to the Marketed Health Products Directorate, the branch responsible for post-market surveillance. [Joel Lexchin in CMAJ, August 3, 2004; 171(3).]

5 Guidelines for Reporting Adverse Reactions to Marketed Drugs. Guidelines for the Canadian Pharmaceutical Industry on Reporting Adverse Reactions to Marketed Drugs (Vaccines Excluded). Published in 1996, Revised July 2001. Health Product Safety Information Division, Bureau of Licensed Product Assessment, Therapeutic Products Directorate, Health Canada. www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/industry_guidelines_e.html

6 Fuller, C, Women & Adverse Drug Reactions: Reporting in the Canadian Context. Women & Health Protection, Toronto. October 2002 (available on the WHP website at www.whp-apsf.ca).

7 Mintzes, B, Drug regulatory failure in Canada: The case of Diane-35. Women and Health Protection, Toronto. October 2004 (available on the WHP website at www.whp-apsf.ca).

8 Clear cell carcinoma has been found in non-DES related cases, but only in post-menopausal women.

9 Dieckmann WJ, Davis ME, Rynkiewicz LM, Pottinger RE. Does the administration of diethylstilbestrol during pregnancy have therapeutic value? Am J Obstet Gynecol 1953; 66(5):1062-81.

10 DES Action Canada provides information about diethylstilbestrol on its website, an excellent example of advocacy on the Internet. Its website address is www.web.ca/~desact/anglais/anglais.html.

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