Healthy Skepticism Library item: 10787

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Publication type: news

Skerritt J.
Avandia concerns spark call for reforms
The Winnipeg Free Press 2007 Jun 12
http://www.msp.mb.ca/PDF_media/Avandia_concerns_spark_call_for_reforms.pdf

Full text:

Drug-approval process endangers patients, experts say

MEDICAL experts are calling for an overhaul of the country’s drug-approval process and say
drugs like Avandia hit the market without proper safety checks.

Last month, an article in the New England Journal of Medicine linked Avandia, a Type 2
diabetes drug, to a greater likelihood of heart attack and possibly death.

Health Canada confirmed that 19 Canadians have died from heart attacks or heart failure
while taking Avandia. A government spokesperson said the drug was possibly the cause of six
of those deaths.

“In the last few years we’ve repeatedly seen cases where drugs have appeared to have gone
on the market too soon — we’ve got Avandia, we’ve got Vioxx, a number of them,” said Dr.
Alan Katz, a researcher with the Manitoba Centre for Health Policy who told a parliamentary
committee several years ago the approval process needs to be changed.

“The sense is that the pendulum has swung in favour of rapid approval with not enough
information and as a result patients are suffering.”

Avandia’s manufacturer GlaxoSmithKline has posted company data on its website arguing the
drug is safe for use.

About 4,200 Manitobans had a prescription for Avandia last year, which cost the province
about $2.5 million.

It is the third most prescribed treatment for diabetes in Manitoba.

Jim Wright, a professor of pharmacology at the University of British Columbia, was part of a
group of health-care professionals who published a warning about Avandia before Health
Canada OK’d its use.

At that time, Wright said GlaxoSmithKline had only two clinical studies published about
Avandia’s safety — both trials lasted only eight weeks, and proved the drug had bad sideeffects
for diabetics. Although short-term trials showed the drug had a positive effect on
blood-sugar levels, Wright said Avandia caused weight gain and a spike in bad cholesterol.
Wright alleges GlaxoSmithKline never proved Avandia reduced the mortality rate for diabetics
or improved their overall bill of health.

“We’ve basically stated no one should be using it from the very beginning,” Wright said. “It’s
shocking.”

Renee Bergeron, a spokeswoman from Health Canada, said Health Canada does not have a set
policy on how long or on how many people a company has to test a drug. In general, they say
this varies with the disease and the expected outcome.

Bergeron said the government collects and monitors adverse reactions from health-care
professionals, patients and drug companies, and requires companies like GlaxoSmithKline to
submit long-term study data for their pharmaceuticals. Health Canada would not release
information on Avandia’s initial clinical trial submission to the government, since it is
considered confidential.

Katz said Health Canada needs to find a better balance between the need for new drugs and
the need for more safety information about the drug.

He said the government could easily beef up its safety checks by requiring more rigorous test
results for longer periods of time after a drug has been approved.

That way, Katz said any red flags would be caught before dozens of patients suffer serious
adverse reactions.

Currently, he said Health Canada relies on pharmaceutical companies to self-report any
ongoing drug testing.

However, Katz said he doesn’t trust companies are honest about the data.

“There isn’t good ongoing monitoring and that’s what we need,” Katz said.

“We can’t rely on the companies to collect and analyze the data. The analysis should be done
by a third party — not the company.”

Health Canada told the Free Press they are currently reviewing Avandia’s safety data, which
could take several months. Wright is adamant the drug should not be sold in Canada, and
thinks Health Canada is watching and waiting to see what the FDA decides.
jen.skerritt@freepress.mb.ca