This week, the pharmaceutical company Pfizer issued letters in both Canada and the United States warning about a serious health risk to women who use their long-acting, injectable contraceptive drug, Depo-Provera.

Pfizer announced that they will be warning doctors and women and adolescents who use Depo-Provera that the drug may cause a significant loss of bone mineral density, that the loss increases with duration, and that the loss may not be completely reversible.

In other words, these women and girls face an increased risk of developing osteoporosis and the fractures associated with the condition. Pfizer also announced that studies on the impact of bone loss during this key period in young women are ongoing.

These warnings come as no surprise to the women's health groups who, in the early 1980's, were already raising concerns about Depo-Provera, its risks to women's health and autonomy, and the troubling circumstances under which the drug was being tested and used.

The history of Depo-Provera's approval in Canada is yet another example of the weaknesses in Canada's drug approval system, a system that is supposed to protect the health of Canadians—including women.

The approval and marketing of Depo-Provera in Canada speaks to a lack of women-sensitive research, the absence of rigorous, transparent drug review and post marketing surveillance processes, and the hazards of ignoring community voices. We are angry and feel betrayed by this latest example of women being used as guinea pigs without their knowledge or consent. Just as with hormone replacement therapy, it has been women's health groups to first ring the alarm bells about our own health issues.

Health Canada approved Depo-Provera for use as a contraceptive in April 1997 after several previous applications by the manufacturer had been denied due to concerns being raised by independent researchers and community groups.

Six years earlier, the Canadian Coalition on Depo-Provera sent a letter to Benoit Bouchard, then National Minister of Health and Welfare, pointing out the risks of osteoporosis identified in a study conducted in New Zealand in 1991 and published in the British Medical Journal which noted a decrease in bone density in Depo users, thereby increasing their risk factor for osteoporosis, a condition that is a significant health risk for Canadian women.

Yet Depo was widely promoted by health professionals to young women and Pfizer was even allowed to advertise its product directly to consumers, something that is illegal in Canada.

We ask, why have we had to wait for thirteen years for the drug company and the government to acknowledge these risks?

How many women and adolescent girls have been unnecessarily exposed to an increased risk of osteoporosis as a result of using Depo-Provera? And who will take responsibility for any resulting fractures? It is important that we learn from this error. Hormone replacement therapy, Vioxx, and Depo-Provera are stories about drugs that all indicate the need for a serious review of Canada's drug approval and monitoring systems. Action is required.

We call on:

1. Health Canada and the Standing Committee on Health to hold hearings to review the history of the use, approval and post marketing surveillance of Depo-Provera.

2. Pfizer Canada to establish an independently managed compensation fund.
Calcium supplements and vitamin D to build bone strength, extra calcium-rich food, exercise programs to increase bone mass, monitoring by health care professionals and possible health care all have costs. We call on Pfizer Canada to use its profits from the sale of Depo-Provera to cover the costs that women and Canada's health care system will have to assume.

3. Provincial and federal governments to seek reimbursement from Pfizer for the health costs of caring for women who have been put at risk for this drug.

4. Provincial and federal governments to immediately put in place community based educational programs for women who have been using Depo-Provera.

5. Pfizer to establish an independent health research program to support a community based research program for women's health.

Our past history clearly demonstrates that women's health groups can be far more reliable and informed source than either the drug companies or Health Canada. We ask how we can prevent this from happening again?

Attachment: Coalition on Depo-Provera's letter to Health Canada, 1991

Contact:
Madeline Boscoe,
Executive Director, Canadian Women's Health Network and co-founder Canadian Coalition on Depo-Provera.
Cell 204-295-2946

Copied from: The Canadian Women's Health Network  http://www.cwhn.ca/indexeng.html