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Drug Safety and Health Canada Going, Going… Gone?

Health Canada’s drug safety procedures lacking, says study
April 20, 2009 | National Office | Topic(s): Health, health care system, pharmacare | Publication Type: Press Release

OTTAWA—Health Canada’s drug safety procedures leave a lot to be desired, says a new study released today by the Canadian Centre for Policy Alternatives.

Drug Safety and Health Canada: Going, Going… Gone? by Dr. Joel Lexchin says Health Canada’s priorities are skewed in favour of rapid approval of new drugs at the expense of the post-marketing pharmaco-surveillance system.

“In Canada 3-4% of drugs approved will eventually be withdrawn from the market because of safety issues and the number of people exposed to these drugs is increasing because of aggressive marketing tactics by the pharmaceutical industry,” says Dr. Lexchin.

According to the study, there are significant limitations to The Food and Drugs Act.

“Health Canada cannot force a drug company to recall drugs deemed harmful from pharmacy shelves,” says Dr. Lexchin. “Nor can they directly compel a company to revise product labels to reflect new safety information.”

In order to improve drug safety, the study makes several recommendations for Health Canada, including:

Stop the treatment safety information as confidential and make it public available promptly after approving a new drug;
Decrease dependence on industry for safety information by using progressive licensing and ensuring post-market studies are undertaken, analyzed, and reported on, independent of industry;
Reorient priorities so that post-marketing pharmaco-surveillance is on equal footing with the approval of new drugs; and
Undertake a systematic study to examine whether faster drug approvals lead to more post-marketing safety issues.
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Drug Safety and Health Canada: Going, Going… Gone? is available from the CCPA website at http://www.policyalternatives.ca http://www.policyalternatives.ca

For more information contact Kerri-Anne Finn, CCPA Senior Communications Officer, at 613-563-1341 x306.


Link

Need, not Greed: Canadian Federation of Nurses Calls for Pharmacare

From the Canadian Federation of Nurses' Statement:

Drugs now rank second after hospitals in terms of share of total health care spending,
having overtaken spending on physicians in 1997. The share of total spending going to
drugs rose from 9.5 percent in 1985 to 16.2 percent in 2002. Spending on drugs is expected
to hit 16.7 percent of total health care spending in 2004, while spending on physicians will
be just 12.9 percent.3

The rapid rise in drug costs is primarily due to the ongoing substitution of newer, more
expensive drugs in place of existing, less expensive products. The newer drugs, in the
majority of cases, have no added benefit. Of the 117 drugs with new ingredients introduced
in Canada between 1998 and 2002, only 15 provided a substantial improvement over
existing drugs.4 The rest are “me-too” drugs that offer little or no therapeutic advances over
existing therapies but are responsible for 80 percent of the increased expenditure on drugs.5

Aggressive advertising by drug companies drives consumption of these me-too drugs.6
Apart from advertising directly to consumers, drug companies spend approximately
$30,000 per year for every doctor in Canada on drug samples, sales rep contact,
conferences, trips and giveaways.7 The influence of pharmaceutical companies on research,
education and clinical practice has also been widely documented.8 Both patients and
doctors are influenced by the onslaught,9 with the result that drug costs are skyrocketing
but health outcomes are not necessarily improving.

Pdf here