York prof questions safety of Canada’s drug-testing procedures


Canada’s cheaper drug-testing procedures put people’s health at risk, says York Professor Mary Wiktorowicz in a new study of testing systems in North America and Europe. She 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,” said Wiktorowicz, of the Atkinson School of Health Policy & Management.

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 that 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 (Vol. 28, #4, Aug. 2003), 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 (up to 12 per cent).”

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 per cent 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 US 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,” said Wiktorowicz. “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.”