DEADLY DRUG CONTINUED TO BE SOLD DESPITE YEARS OF WARNINGS

HAMILTON - A Health Canada official testified yesterday that the department
knew of cardiac problems linked to a popular heartburn drug as early as
1995. But it did not stop sales of the drug until five years later, when
the medicine's marketer advised it of an impending warning from the U.S.
regulator.

Dr. Brian Gillespie, Health Canada's senior medical advisor on
pharmaceutical assessment, was appearing at the inquest into the death of
Vanessa Young, a 15-year-old Oakville girl who died of heart failure after
taking the drug on March 19, 2000.

Vanessa had been taking Prepulsid, also known as Cisapride, for about a
year to help her keep food down. She had bulimia, a disorder characterized
by binge eating and self-induced vomiting.

An autopsy determined the drug had caused her heart to beat irregularly.

Dr. Gillespie recounted yesterday how reports from the United States and
Health Canada's own bulletin of adverse drug effects reported
Cisapride-linked cases of cardiac arrhythmia every year from 1995 to
January, 2000, when the drug's manufacturer informed Health Canada the U.S.
Food and Drug Administration was issuing a warning about "serious adverse
events associated with the use of Cisapride."

At that time, Dr. Gillespie said, Health Canada initiated a complete review
of risks and benefits and established a working group to investigate links
between the drug and heart problems. Even though it had determined by
February there were serious risks associated with taking the drug, Health
Canada did not order a stop sale for Cisapride until the end of May; the
drug did not come off the market until August.

It was during this interim period that Ms. Young died.

As far back as 1992, the British Medical Journal had warned the drug could
cause heart problems.

The warning, which stemmed from a study by the World Health Organization,
was reported in September, 1992, but does not appear to have come to the
attention of Health Canada officials in their monitoring of the drug.

Prepulsid, which was marketed by Janssen-Ortho Inc., is no longer on the
market, but was widely prescribed in the past decade.

"At the end of it, we believed that there were serious risks associated
with the use of this drug, but in certain patients this was a very valuable
drug. In some cases their health, and even their lives, depended on it,"
Dr. Gillespie said. "It was a very difficult decision weighing out the
risks and the benefits in this case."

Dr. Gillespie described the process by which Health Canada approves and
monitors drugs in Canada as thorough and complex. Yet when asked about the
1992 World Health Organization study, Dr. Gillespie admitted he did not
know if Health Canada was ever aware of the report.

The report found patients taking Cisapride developed heart irregularities
during their treatment.