Breast Cancer Prevention and Hormone Manipulation:The Heat is On: Other Opinions Wanted

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by Sharon Batt

On April 6th, the top-billed news story across Canada was that a pharmaceutical drug could cut the risk of breast cancer by forty-five per cent in women at increased risk of the disease. The investigators who designed the trial called the finding a "breakthrough" and an "historic stride". According to the letter sent to the study's 13,388 participants, and quoted in the breathless coverage, this was "the first study in the world to show that a drug can reduce the incidence of breast cancer." My heart sank as I looked at the newspaper headlines: in six years we had come full circle.

The launch of the Breast Cancer Prevention Trial was one of those defining moments for me. For eight months, I and three other women with breast cancer had been meeting to plan an activist group in Montreal, the first of its kind in Canada. We scheduled a public meeting in April 1992 to launch our organization, which would give women with breast cancer a voice in policy discussions about the disease. No sooner had we declared our existence when the chief spokesperson for the Canadian section of the trial, prominent Montreal oncologist Richard Margolese, announced the plan to recruit 16,000 North American women. Half would be given the drug while the other half would receive a look-alike pill (placebo). Our dismay became the cournterpoint to his enthusiasm. We wanted prevention to be a breast cancer priority, but drugging healthy women was not the strategy we had in mind.

Tamoxifen has been used as a breast cancer treatment since 1978, with notable success. Women with breast cancer who take tamoxifen are less likely to have a recurrence in their other (healthy) breast. The investigators predicted that if they gave the drug to women at higher-than-average risk, they could reduce their risk of developing breast cancer. The results of the trial proved them right - at least in the short term. With a tally of 85 breast cancer cases among tamoxifen-takers vs. 154 cases in the placebo group, the research team decided to declare victory and stopped the trial more than a year ahead of schedule.

Opponents of the trial were also right, however. When this prevention trial was mounted, critics
at the Women's Health Network in Washington, D.C. argued that giving tamoxifen to healthy
women was a strategy of "disease substitution", not disease prevention. As a treatment for women who have breast cancer, tamoxifen was known to raise the risk of endometrial cancer and blood clots in the lungs and other major veins. In the prevention trial, women taking tamoxifen suffered 135 per cent more endometrial cancers (33 cases vs 14). They suffered 47 cases of blood clots in the lungs or major veins compared to 25 cases in control group participants. The results offered no evidence that taking tamoxifen would reduce mortality. Five women in the control group died of breast cancer. In the tamoxifen group, three died of breast cancer and two died of a blood clot in the lung.

The steady rise in breast cancer incidence is alarming and preventing the disease must clearly be a priority. The different views of this trial reflect a fundamental divide in perspective, however. Women's health advocates have long deplored the profitable over-medicalization of our health. This research project is but another example of a narrow, medical approach that is at odds with the direction many women would take if our voices were heard at the policy level.
For decades, the strategies for controlling breast cancer have been set by medical specialists and commercial interests, with virtually no input from women living with the disease. The result is a view of breast cancer prevention that mirrors the perspective of these interest groups. Efforts to contain the disease focus on early detection, treatment and recently, the identification of genetic markers. The bulk of the research money for breast cancer goes to studying mammography, to testing treatments and to genetic research on mechanisms at the cellular level.

The language of breast cancer prevention is distorted to support this skewed vision. Early
detection is called "secondary prevention". Treatment is referred to as "tertiary prevention".
Usually, "primary prevention" refers to halting a disease at its source, through safe public health strategies like a clean environment, a healthy diet and exercise. Advocates of the breast cancer prevention trial talk about "chemoprevention", implying that prescribing drugs to the healthy falls within the purview of primary prevention.

The National Forum on Breast Cancer, held in 1993, marked the first time in Canada that women with breast cancer and other interested citizens were invited to help shape public policy concerning this disease. The vision that arose from this meeting emphasized a holistic approach in which consumer participation was key. On the subject of the tamoxifen trial, the Forum's Report states: "The question of hormone manipulation, by whatever means, remains highly controversial and a matter of widespread concern. Participants called for a full and open debate on all the implications of this approach to prevention and for the discussion to include input from women." The action plan includes a recommendation to promote such a debate, "including a consideration of the social and ethical implications of this approach."

This debate has never taken place. Meanwhile the abrupt, early cessation of the trial has raised the public's hopes of an easy solution to the breast cancer crisis. The pharmaceutical company Eli Lilly is piggy-backing on the trial's publicity by aggressively promoting raloxifene, a tamoxifen cousin whose long-term benefits and risks are still unknown. Other companies are sure to follow, confusing the issue further and entrenching chemoprevention as a "choice" for women worried about their breast cancer risk.

We need low-cost, safe strategies to maintain a healthy population and this means looking to true primary prevention. We need to act before the results of this trial are moved into practice. The Canadian Breast Cancer Network, in collaboration with Breast Cancer Action Montreal, urges all women's health groups and advocates to join us in calling for a debate in which women are true participants, not simply targets for drug company hype.

For further information contact:
The Canadian Breast Cancer Network
102, 207 Bank St.
Ottawa, ON K2P 2N2
Tel 613/788-3311, fax 613/233-1056,

Sharon Batt is a founding member of Breast Cancer Action Montreal, and author of Patient No More: The Politics of Breast Cancer.

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