"...patients are being misled into assuming the benefits are greater
than they are, {CMAJ editor} Dr. Hoey says.

CMAJ * January 4, 2005; 172 (1). doi:10.1503/cmaj.045206.
Vioxx: lessons for Health Canada and the FDA
http://www.cmaj.ca/cgi/content/full/172/1/5

January 5, 2005

The Ottawa Citizen

Canada fails 'miserably' at protecting public from unsafe drugs
Medicines approved too easily, not tracked to ensure safety, top
journal argues

by Sharon Kirkey

Health Canada has failed "miserably" to protect Canadians from harmful
drugs and the bar for approval is so low the agency has sanctioned
medicine without adequate proof of safety, Canada's top medical
journal says.

The Canadian Medical Association Journal says Health Canada had to
know of the higher risk of heart attack and stroke in patients taking
the arthritis pill Vioxx years before the drug was voluntarily pulled
from the market in September, and there was no need to fast-track
approval of the "me-too" painkiller in the first place.

A me-too drug is chemically similar to drugs already on the market.

"It has now become clear that both the FDA and (by inference) Health
Canada were aware of the increased risk of cardiovascular adverse
events long before the drug was withdrawn" in the biggest drug recall
in history, the CMAJ says in an editorial in this week's issue.

The journal is calling for a new, arm's-length agency to track the
safety of new pills once they move out of carefully controlled drug
company studies and into the "Wild West" of day-to-day practice.

The journal criticizes Health Canada's "built-in bias" toward
approving drugs without adequate safety data, as well as its
"fragmentary and underfunded" drug surveillance system that relies on
doctors to voluntarily flag bad drug reactions.

The journal calls this a "fundamental and (often literally) fatal
flaw," and says tougher drug monitoring would have sounded alarms
about Vioxx much sooner.

"Both the FDA (U.S. Food and Drug Administration) and Health Canada
have failed miserably in carrying out this important aspect of their
public mandates."

Even a simple review of ongoing studies of Vioxx would have revealed
four years ago a statistically significant increased risk of heart
attack and stroke, the journal says. "Why did it take four years for
the increased risk of serious cardiovascular adverse events to
emerge?"

The editorial follows a recent rash of alerts about drugs that have
been prescribed to millions of patients, from warnings that Paxil and
related antidepressants may cause suicidal thinking in children, to
more reports of a rare, but potentially fatal, muscle disorder in
people taking the anti-cholesterol pill, Crestor.

Vioxx was pulled from worldwide markets after studies showed the
top-selling painkiller doubled the risk of cardiovascular reactions.

Then, last month, Pfizer alerted doctors its painkiller, Celebrex, a
COX-2 drug, may increase the risk of heart attack, strokes and blood
clots, based on one study that was testing the drug as a treatment for
cancer.

Health Canada issued an advisory last week warning of a "strong
possibility" of an increased risk of cardiovascular reactions in
certain patients taking COX-2 drugs. But the regulator said there's
not enough data to know which patients are at the highest risk.

A spokeswoman said the agency was aware of long-standing concerns
about the heart safety of Vioxx but that there was no consensus until
last year on the risk.

Catherine Saunders also said Health Canada has been analysing the
safety of similar drugs since Vioxx was pulled and the department
warned of a possible increased risk of cardiovascular reactions in
Vioxx users in an April 2002 advisory.

The CMAJ says the government should have acted sooner.

"Health Canada and the FDA, when they finally get around to deciding
there ought to be a warning, they get it out shortly. The problem now
is, why is it taking so long to find out?" CMAJ editor Dr. John Hoey
asked in an interview.

"What we want them to do is to get out ahead of the curve and, as soon
as a drug is marketed, to begin to aggressively look for specific
side-effects," he said.

"No one is really looking out to find these rare but important
side-effects."

That means patients are being misled into assuming the benefits are
greater than they are, Dr. Hoey says.

He says companies only need show their drug is better than taking a
placebo, or "dummy pill" to get approved, and not that they're better
than older drugs already on the market.

© The Ottawa Citizen 2005