E-DRUG: Regulatory Secrecy
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The following is a press release, issued by the Canadian Medical
Association Journal (CMAJ), based on an editorial of mine which appears
in the current issue of the CMAJ. E-druggers who want to read the entire
article can find it on the CMAJ web page:
www.cma.ca/cmaj/vol-159/issue-5/0481.htm
Secrecy and the Health Protection Branch - Joel Lexchin
Information about drugs undergoing regulatory approval is shrouded in
secrecy, writes Dr. Joel Lexchin. The Health Protection Branch does not
yet publicize which drugs are under review, has no public, external
advisory committees to discuss these drugs and provides limited
information following the review. This deprives both health care
professionals and consumers of essential information.
Dr. Lexchin also found it's difficult to obtain studies used in the
approval process. He has already waited 21 months for the studies used
to approve certain pediatric antidiarrheal agents. He writes that this
lack of access to information can create hazards.
In the US, requests for studies about a new drug are honoured within 10
working days, a summary for the basis of approval is also released,
and the review of many drugs is referred to an expert advisory committee
before a final decision. These committees are open to the public.
Dr. Lexchin points out that due to government cutbacks the Canadian
directorate in charge of regulating drugs and devices now receives about
70% of its financing from fees paid by pharmaceutical and other companies.
To assure public safety and demonstrate that there is no conflict of
interest, he argues for rapid and open access to more information.
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Joel Lexchin MD
121 Walmer Rd.
Toronto, Ontario
CANADA M5R 2X8
Phone: (416)-964-7186
Fax: (416)-923-9515
email: joel.lexchin@utoronto.ca
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