[news] Transparency in Drug Regulation: Mirage or Oasis?

[Resist!ca]

Joel Lexchin and Barbara Mintzes Dr. Lexchin is an Emergency Physician with the University Health Network, and Associate Professor, School of Health Policy and Management, York University, and is Associate Professor with the Department of Family and Community Medicine, University of Toronto, Toronto, Ont. Dr. Mintzes is a Postdoctoral Fellow in the Department of Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC. Correspondence to: Dr. Joel Lexchin, 121 Walmer Rd., Toronto ON M5R 2X8; fax 416 923-9515; joel.lexchin at utoronto.ca In Canada, the information used to approve new drugs is deemed commercially sensitive and hence confidential under the Access to Information Act and the Therapeutic Products Directorate (TPD) will not release such information without the manufacturer's approval. As a consequence, safety and efficacy information contained in unpublished trials submitted to the TPD is generally unavailable to researchers, physicians and patients, a situation that can potentially lead to the inappropriate prescribing and use of medications.

URL: http://resist.ca/story/2005/4/26/20810/1084