Citing the recent withdrawal of refecoxib (Vioxx), members of a new national consumer network say Health Canada and Canadian doctors are failing in their duty to protect the public from harmful drugs.
“The evidence is clear, something is broken in the system and we should get busy and fix things,” BC family physician Dr. Warren Bell said at the Mar. 18 Vancouver conference that gave birth to the network PharmaWatch/PharmaVeille.
Bell is a board member of the previous PharmaWatch, a Vancouver-based advocacy group spearheading the new organization which aims to involve the public in every stage of Canada's drug regulation process.
The other two founding groups are DES Action Canada, which was formed in 1982 in response to serious adverse reactions to DES (diethylstilbestrol), and l'Union des consommateurs, a Montréal-based consumer group that has launched a class action suit against Pfizer, the maker of celecoxib (Celebrex).
Although the conference focused on how to improve direct consumer reporting of adverse drug reactions, participants said consumers must also be part of other stages, including drug approvals and postmarket surveillance.
“We think citizens have a right to be involved in the approval process,” said PharmaWatch and network head Colleen Fuller.
“The public should have full access to information about clinical trials being conducted, the reasons why a drug has been approved or not approved. And that means the government has to open the doors to people, and citizens have to step forward themselves.”
Dr. James Wright, managing director of the Therapeutics Initiative at the University of British Columbia, illustrated the inadequacy of the current system through the example of COX-2 inhibitors.
In early 2001 Wright published information from a rofecoxib trial showing that the drug was associated with an increase in life-threatening events (CMAJ 2002;167:1131-7).
“The regulators are passive,” says Wright.
The network hopes to create a bilingual Web-based source of drug information; help Canadians play an active role in developing public policies that reduce the harmful effects associated with prescription drugs, including working for a ban on direct-to-consumer advertising; support equitable access to safe medicines and non-drug therapies; and encourage consumer reporting of adverse drug events.
Health Minister Ujjal Dosanjh recently announced Health Canada's new commitment to greater transparency and increased consumer involvement in decision-making about drug safety (CMAJ 2005;172:733). — Alicia Priest, Victoria
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