Cheaper drug testing comes at a cost: York U. professor
Globalization lowers safety standards, increases public health risks
TORONTO, October 1, 2003 -- Canada's cheaper drug-testing procedures put
people's health at risk, says York University professor Mary Wiktorowicz in
a new study of testing systems in North America and Europe. Prof.
Wiktorowicz says Canada's system for vetting new drugs has become more like
those used in Britain and France where recalls of new drugs are four times
higher than in the US.
"Drugs with potentially dangerous side effects are going out into the
market and our medicine cabinets before they have been subject to as
stringent testing as used in the US," Wiktorowicz says.
The study also asserts that as pressure from transnational drug companies
to harmonize global testing procedures continues, Canada is moving towards
less stringent standards and relying on advice from experts who have a
conflict of interest with the drugs they test.
In her analysis of the regulatory systems of four countries, Wiktorowicz
says Canada uses a hybrid of the European systems, which are more
streamlined and responsive to the pharmaceutical industry, and the American
system, which emphasizes independent testing. The study reveals Canada,
Britain and France are more likely to work with and accommodate drug makers
throughout the regulatory process in order to speed approvals, attract
research and development, and create hi-tech jobs.
The study, published in the Journal of Health Politics, Policy and Law,
draws on a large body of research into how drugs are tested and regulated
and develops a comparative model of national testing systems. Those systems
are also characterized based on different criteria including political
culture and social policies.
"In the US, lower drug recall rates (three per cent) are achieved through
more stringent standards," Wiktorowicz says. "Conversely, the other three
countries regulate pharmaceutical prices to ensure national health care
programs remain affordable, but adopt less stringent safety standards,
leading to higher recall rates."
The research also shows:
Canada relies on international, brand-name pharmaceutical companies for
advice on its drug-approval policies and largely ignores the opinion of
generic drug manufacturers and consumer groups.
The more stringent system used in the US reduces risk at the cost of more
extensive testing and litigation.
Due to a 40 per cent cut to the departmental budget in 1999 and a policy of
cost-recovery, the pharmaceutical industry now pays for 70 percent of
Health Canada's testing.
Canada negotiates regulatory matters with the pharmaceutical industry from
a weaker position due to its limited resources for independent testing.
Health Canada delegates the policing of advertising claims to drug
companies and their experts.
Drug testing is controlled by government employees and is rarely subject to
review by Parliament, unlike the US Food and Drug Administration (FDA)
which is regularly scrutinized by Congress and the Senate.
The U.S. system, while the most effective at minimizing risk, is also the
most expensive of the four countries studied.
Wiktorowicz emphasizes the need for post-market studies of new drugs to
minimize risk to public health brought about by recent global changes in
drug testing patterns. The study shows that as many as 10 per cent of new
drugs are discontinued due to safety problems not found in pre-market
clinical tests. Wiktorowicz says surveillance of a drug's use after it is
released can offset the risks introduced by shorter test cycles and rapid
approvals favoured by the industry and some consumer groups.
"The importance all societies place on health and longevity makes the
safety and effectiveness of medicines a high priority," Wiktorowicz says.
"In the current era of globalization, each nation must address the
challenge of developing a regulatory framework that balances the competing
goals of protecting the public interest while promoting industrial
competitiveness. Canada has moved from a comprehensive regulatory system of
pharmaceutical assessment, to that of risk management. Whether such change
serves the public interest is a matter of public debate."
The School of Health Policy and Management in the Atkinson Faculty of
Liberal and Professional Studies at York University employs an
interdisciplinary approach to health systems education, focusing on the
social determinants of health, such as, age, race, and access to health
care, and the effectiveness of health care delivery systems. The School
promotes learning from a human wellness perspective, with a goal to
improving the health of individuals and communities alike.
-30-
For further information, please contact:
|-----------------------------------+-----------------------------------|
| | |
| Nancy White | David Fuller |
| | |
| | |
| Director, Media Relations | Media Relations |
| | |
| | |
| York University | York University |
| | |
| | |
| 416-736-2100, ext. 55603 | 416-736-2100, ext. 22091 |
| | |
| | |
| [log in to unmask] | [log in to unmask] |
|-----------------------------------+-----------------------------------|
YU/101/03
To unsubscribe send one line: unsubscribe click4hp to: [log in to unmask] . To view archives or modify subscription see: http://listserv.yorku.ca/archives/click4hp.html
|
