There has been a lot of press coverage recently in The Toronto Star related to the pharmaceutical industry and Health Canada. My letter to the editors is provided below, along with links to some recent articles for background.
I welcome your thoughts on how to work with the media to change the messaging about clinical trials. How can we impress upon them that stories such as these irreparably damage the trust of the public and will impact their willingness to participate in clinical trials?
Until next time,
To the editors:
The public discourse arising from recent Toronto Star coverage of Health Canada and the pharmaceutical industry is welcomed by the Association of Clinical Research Professionals (ACRP).
Our organization represents and supports approximately 14,000 clinical research professionals around the world, including many who conduct clinical trials in Canada.
ACRP supports transparency in the drug development process and public access to government-led clinical trial inspection records. We believe transparency fosters accountability, both of which reflect a commitment to ethical standards. Transparency is a critical component in building the trust our industry asks of the women and men who voluntarily agree to participate in clinical trials. New medicines cannot be developed without clinical trials, trials cannot be conducted without volunteer subjects, and volunteers will not participate without trust. Furthermore, publicly accessible trial inspection records can be put to use as educational resources to help ensure mistakes of the past are not repeated.
It should be noted, however, that Health Canada is not alone in its current practice of restricting public access to clinical trial inspection records. The Star says Health Canada’s U.S. counterpart “has a stricter enforcement regime,” but fails to mention that Health Canada’s policy pertaining to publication of trial inspection records is more representative of the global norm than that of the FDA. Instead, the Star mischaracterizes and sensationalizes Health Canada’s policy as one of “extreme secrecy.”
The Star makes further claim that Health Canada is putting Canadians’ health at risk “with its secrecy and overly cozy relationship” with “pharmaceutical giants.” Yet in none of its recent reporting does the Star provide its readers with evidence of an “overly cozy relationship” between Health Canada and pharmaceutical companies.
Public-private collaboration is beneficial in many industries and is not unique to drug development. Classifying public-private collaboration as “secretive” or “overly cozy,” without accompanying supporting evidence, is a disservice to Star readers and paints an inaccurate picture for the public that unnecessarily and irresponsibly cultivates distrust, discourages trial participation, and by default casts an underserved shadow on the thousands of dedicated professionals, fellow Canadians, who conduct clinical trials responsibly and ethically.
We encourage open, honest, and accurate discussions of drug development issues in the future.
Canadians kept in dark about defective drugs (Sept. 11, 2014)
Drug-testing rules broken by Canadian researchers (Sept. 16, 2014)
Health Canada needs to show backbone with drug companies: Editorial (Sept. 21, 2014)
Apotex to quarantine suspect drugs from factory in India (Sept. 25, 2014)