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Safety and the Precautionary Principle Public Health vs. Profit Lessons from the Past - Ongoing Risks
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Safety First: Women and Health Protection
This issue of the Research Bulletin features the contributions of Women and Health Protection, formerly known as the Working Group on Women and Health
Protection. This group is supported in part by the Women’s Health Contribution
Program of Health Canada and is composed of researchers, health providers,
educators, and consumers interested in policy-directed research and public
education on health protection issues. I am pleased to welcome Anne Rochon Ford,
Coordinator of Women and Health Protection, as guest editor. As you will learn
in this issue, women in Canada have had an alarming history with respect to
pharmaceutical products and medical devices. The articles that follow caution
regulators, consumers, practitioners, and researchers to learn from the past in order
to protect women’s health in the future. Both women and men, young and old, suffer the ill effects of drugs and medical devices that are inadequately tested and then insufficiently monitored once they are released. However, on closer examination, it would seem that women have been the proverbial canaries in the coal mine when it comes to the safety of drugs and medical devices in Canada. Consider the dubious legacy. DES (diethylstilbestrol), a hormone drug, was known to cause serious reproductive problems in animals as early as the 1930s, and was shown to be ineffective in preventing miscarriage in women by the mid- 1950s. Yet it was prescribed to pregnant women until the early 1970s when serious cancers and other reproductive problems began to be identified in the daughters and sons of women who had taken DES. In the 1970s, the Dalkon Shield intra-uterine contraceptive device was found to cause infertility and life-threatening uterine infections only after it had been approved for marketing. In the late 1980s, the Meme breast implant was associated with questions about serious systemic complications and eventually removed from the market. Women’s health and disability advocates raised concerns about injectible and implanted contraceptives, such as Depo-Provera and Norplant, soon after marketing had begun, but warnings about harmful effects were only issued years later after millions of women worldwide had used them. Most recently, in 2002, the finding that harm outweighs benefit with long-term use of hormone replacement therapy, comes after millions of women were prescribed hormones and before research had proved efficacy and long-term safety. There is increasing evidence for concern that harmful effects to animals from estrogens in the environment may also translate into human harm. This issue of the Research Bulletin highlights some ways that women’s health researchers and advocates are working to try to avoid having history repeat itself. Penny Van Esterik of the National Network on Environments and Women’s Health offers a balanced perspective about the warnings relating to breast milk and environmental contaminants. Researchers affiliated with the B.C. Centre of Excellence for Women’s Health, furthering the innovative work of Ruth Cooperstock from the 1970s, describe the continuing problem of overprescription of benzodiazepines to women. Ann Pederson and Aleina Tweed, also of the B.C. Centre, present the case for the creation of a breast implant registry to alert women to, and gather evidence about, health problems associated with these devices. Women and Health Protection, backed with evidence from research by Barbara Mintzes, calls upon Health Canada’s Health Products and Food Branch to resist pressure to approve direct-to-consumer advertising of prescription drugs and warns of concerns about harmful drugs like Diane-35. Their message to our legislators is clear—put safety, not profit, first, and adhere to the precautionary principle. As Sharon Batt notes elsewhere in this issue: "The widespread myths about hormone therapy were based, not on science, but on marketing that subverted science". She argues forcefully for the need to be looking not to pharmaceuticals but to some of the fundamental tenets of public health—clean air, healthy workplaces, and the social determinants of women’s health—for disease prevention. Colleen Fuller draws attention to shortcomings in our current post-market drug surveillance system. Women’s particular susceptibilities to drug-related health risks must be taken into consideration by Canada’s adverse drug reactions reporting program. In an article about Canada’s role in the process of the International Harmonisation of Pharmaceuticals, Women and Health Protection, using original work done by John Abraham, again urges that safety standards be paramount and the particular needs of women and other groups are not lost. The legacy that began with DES can stop here. Our national policy-makers have not only the responsibility but the tools at hand to transform our health protection system, making it one that is more responsive to women’s health, and ensuring better health for all. Any proposed legislation and regulations should undergo a gender-based analysis and conform to the federal government’s "Plan for Gender Equality" and "Health Canada’s Women’s Health Strategy". What is needed is the political will to make these changes.
The Steering Committee of Women and Health Protection |
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