Drug Approval in Canada

The tragic death of fifteen-year-old Vanessa Young did more than send one family into despair. It highlighted serious and life-threatening issues within Canada's drug approval system.

In March 2000, Vanessa died of cardiac arrest in her father's arms. She had been taking Prepulsid (cisapride), a heartburn drug linked to more than 80 deaths in the US and 25 in Canada. A coroner's inquest revealed that Health Canada didn't issue a warning about Prepulsid until Feb. 25, 2000 five weeks after American doctors received theirs. On Aug. 7, 2000, that Canadian manufacturer, Janssen-Ortho Inc., was ordered to stop selling the drug again, several months after it was pulled off American shelves. More than seven million Canadian prescriptions had been written by then.

In this case and others, many have accused Health Canada of not acting quickly enough. In March 2002, a Health Canada spokesperson announced the creation of a new organization to improve drug monitoring. But is this a case of closing the barn door after the animals have already escaped? A big concern remains Canada's drug approval process, the front door through which drugs must pass.

Health Canada does not conduct independent drug studies; it relies on those provided by the drug companies, which are very careful about what aspects of their studies reach public domain.

How Do Drugs Get Approved?

A manufacturer must submit details about a drug's safety and efficacy using results from tissue sample, animal and human studies to Health Canada's Therapeutic Products Directorate. The agency reviews this data, which includes information on side-effects and claims for use. An estimated 10 per cent of all drug submissions are approved. They receive drug identification numbers (DIN) and marketing begins using product literature also approved by Health Canada.

Ideally, this system would be open and free from conflict of interest. But some experts are raising a red flag. Since the mid-1990s, both the US and Canadian governments have charged the pharmaceutical industry to pay for drug regulation and approval causing an arguably close partnership between drug regulators and manufacturers.

Drug companies fund their own research, which allows them control over what regulators review. Health Canada does not conduct independent drug studies; it relies on those provided by manufacturers. "Clinical trials funded by drug companies are more likely than non-industry funded trials to generate 'scientific evidence' that favours the funding company's product, and the data is more favourably interpreted by those with financial ties related to drug companies," write academics Morgan, Barer and Evans from the University of British Columbia's Centre for Health Services and Policy Research. In their report on how drug companies can manipulate the system for profit, they add, "Drug companies are also very careful about what aspects of their studies reach public domain."

In the US, anyone can access both data submitted to the Food and Drug Administration, as well as unpublished safety and efficacy information.

Pre-approval public meetings are also conducted. However, in Canada, drug decisions are closed door, the information labelled "proprietary" and thus off-limits increasing the possibility of skewed decisions and reducing public confidence.

Another related concern is drug use for children. Most children currently use prescriptions for drugs tested only on adults. Dr. Desmond Bohn of Toronto's Hospital for Sick Children states drug companies should be required to test products on children before going to market (CBC Online Nov. 12, 2002).

Once drugs are approved, less-than-perfect public safeguards exist the focus of another alive article next month. The result: unsafe drugs linger on the market longer than desirable, causing side-effects and deaths. Prepulsid (cisapride) is just one example. The US-based consumer group Public Citizen advises waiting at least five years from the date of marketing to try any new drug unless it is a "breakthrough" drug that offers documented advantages over older drugs. "New" doesn't necessarily equate with "better" as many new drugs are merely reworked versions of others already on the market.