Drug’s approval sends shock waves through women’s organizations

On October 29th, the U.S. Food and Drug Administration—under intense pressure from drug lobbyists—gave up its two-decade-long battle to protect American women from the side effects of Depo-Provera, an injectable steroid drug that prevents pregnancy for three months.

Editor’s Note: Depo-Provera in some cases may prevent ovulation.  In other cases, there may be ovulation and fertilization, but the drug’s effect on the uterine lining causes an abortion.

The approval of Depo-Provera for marketing in the U.S. has sent shock waves through women’s health organizations in Canada.  We all fear that – after years of refusing

Approval for the drug—the Canadian government may be stampeded into blindly following the American Lead.

Benefits” of Depo-Provera

The U.S.F.D.A’s advisory committee reported that Depo-Provera’s “potential benefits” outweighed the risks.” Among the “potential benefits” according to Dr. David Kessler, U/S.F.D.A. Commissioner, “Depo-Provera eliminates problems related to missing a daily dose.”

The clientele   who might “miss daily dose” were identified for the New York Times by David J. Andrews, acting president of Planned Parenthood.  “Planned Parenthood …hoped it would be priced below birth control pills and would be offered to public health clinics at a reduced rate so it can be discounted or low-income patients.”

Cindy Pearson of the U.S. National Women’s Health Network, which has long opposed approval of Depo-Provera, said that “health advocates for low-income women and minority women are concerned about Depo-Provera being pushed on women at clinics because it is an easy means of providing contraception and of assuring compliance.”(emphasis added, New York Times, October 30, 1992

Depo-Provera is administered as an injection into the muscle at the back of the arm or in the buttocks.  Some women’s health advocates speculate that aggressive local welfare administrators may unofficially and coercively seek to limit the number of children born to a single mother by trying a client’s welfare status to her agreeing to receive Depo-Provera injections.

Dangerous side effects

There have been a number of reported incidents of Depo-Provera    being forced on poor women in the developing world, where most of the world’s nine million users of the drug live.  This problem may be exacerbated now that the U.S. Agency for International Development—which provides a majority of the contraceptives used by programs in the developing world—has the green light to ship the drug to Africa, Asia and Latin America.

The transnational pharmaceutical giant Upjohn, which lobbied the U.S.F.S.A. for the right to market Depo-Provera, will retail its lucrative product for $25-40 (U.S.) per injection. U.S. government approval will likely ease lingering concerns about the drug’s safety and lead to a world- wide profit bonanza for Upjohn.

But what about Depo-Provera’s safety: Dr. Sidney Wolfe of Ralph Nader’s Public Citizen Health Research Group told CNN that there were more health risks known to be associated with the contraceptive now than ten years ago. Of particular concern are recent studies –seemingly ignored by the US.F.D.A.– which link the drug with osteoporosis, a disease that can deplete bone mass , leaving bones thin, brittle and easily breakable.

Ms. Pearson, program director of National Women’s Health Network, added this concern: “We are very sorry it was approved. “We are concerned about bringing a drug liked to cancer into a county (the U.S.) where the risk of breast cancer already is so high.”

The U.S. F.D. A. advisory committee in recommending approval of Depo-Provera cited a World Health Organization report indicating “if all women were counted, there was no additional breast cancer in Depo-Provera users.” (N.Y.T, October 30, 1992).  However, in the same report the W.H.O. cited evidence that   women under 35, the breast cancer rate increased! (emphasis added)

Unfortunately, the Associated Press and Canadian Press wire services failed to register the slightest incredulity at this use of statistics, reporting dutifully instead: “Recent studies have indicated the link of [with cancer] may not be as strong as previously believes [sic]

Fifteen or more years ago Depo-Provera which has never gained approval in Canada as a contraceptive, was prescribed for that purpose (through legal loopholes for teen-aged girls in group homes in Winnipeg and retarded women in institutions.  “An Ontario inquiry into the drug’s use on the retarded in early 1980 found higher-than-normal levels of breast tumours.” (Globe and Mail, September 16, 1986)

Depo-Provera severely disrupts the menstrual cycle and fewer than one-third of women report normal menstrual cycles during the first year of use.  Approximately 15 per cent of women discontinue because of bleeding irregularities and another 12 per cent give it up because of amenorrhea (complete absence of monthly periods) (World Health Organization). W.H.O. cautions: women who have not had children “might be advised to use other methods [of contraception]

Protecting Canadian Women

Other troubling side effects of Depo-Provera include abdominal pain, tiredness, painful menstruation, weakness, dizziness, nervousness, headaches, weight gain, raised blood glucose levels, skin pigmentation changes, and loss of libido. (sex drive). (W.H.O.)

Newspapers across Canada reported on October 30 that Canadian federal health officials are consulting with scientists in the private sector (most probably pharmaceutical companies including Upjohn ..to see whether the drug should be approved for contraceptive use.” (Canadian Press, October 30, 1992, emphasis added)

This is the same kind of “consulting” –closed-door meetings between federal officials and scientists in the in the employ of the big drug companies—that the Canadian Coalition on Depo-Provera successfully resisted six years ago.  Then the Coalition, an umbrella group of 84 organizations including the National Action Committee on the Status of Women, demanded—and got—public hearing on the drug.

This women’s health vs. politics division must not impede our fight against this drug.  Depo-Provera as a contraceptive has proven dangers for women’s health, and the Canadian government has wisely refused to approve it as such. Women and men across Canada must demand that this prudent prohibition continues. (This article has appeared in the Vancouver Sun and London Free Press)