Bad birth control?

Bad birth control? McGill University

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McGill Reporter
October 11, 2001 - Volume 34 Number 03
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Bad birth control?

Fear of an overpopulated planet has led to much rhetoric and drastic action over the years. Dr. Shree Mulay oulined just how drastic in her recent talk on "Sex, Lies and Population Lullabies: Contraceptive Trials in Developing Countries."

Photo Dr. Shree Mulay
PHOTO: Owen Egan

As far back as 1798, Malthus declared his "principle of population." Something must be done, he wrote, because while population increases geometrically, subsistence increases arithmetically. We were destined to run out of food. Time proved him wrong -- if his calculations had been right, the U.K. would be 1.8 billion people strong.

More recently, in a 1935 letter to a sponsor, feminist and contraceptive crusader Margaret Sanger suggested sterilization for "dysgenic types" who would surely otherwise die if it were not for government handouts.

Although such miscalculations and classism are outdated, there is still a widespread global eagerness to develop cheap, easily available contraception. Sustainable development and maternal mortality are two arguments for pushing ahead research on birth control. But the facts beg the focus.

For example, there are many factors behind maternal mortality. Merely being pregnant and giving birth rarely presents a risk for death in and of itself. More commonly, lack of hygiene, poor training, a shortage of hospitals and other factors underscore the health and socioeconomic problems in developing countries.

Much contraceptive research focuses on provider-control methods, as well as non-surgical sterilization.

Mulay is critically researching a large-scale sterilization program using quinacrine. This antimalarial drug was taken orally by over a million soldiers in WWII. In Chile, in the '70s, Dr. Jaime Zipper used it as a method for non-surgical sterilization by inserting a pill, IUD-fashion, in the uterus. Later, an American trial using a quinacrine "slurry" led to two deaths and in Bangladesh another died.

Although orally safe, Mulay said that when quinacrine is inserted into the uterus it "can cause toxic effects and convulsions."

Drs. Stephen Mumford and Elton Kessel are quinacrine's principal advocates and the chief figures behind these clinical trials. In 1987, they stated that the risks associated with using quinacrine as a contraceptive are far less than the huge risks of over-population.

But the long-term effectiveness of quinacrine sterilization (QS) is questionable, says Mulay. The director of the McGill Centre for Research and Teaching on Women and a medical researcher, Mulay estimates a 10-14% failure rate over time, and cites an elevated risk of ectopic pregnancies -- a potentially life-threatening form of pregnancy in which implantation of the fertilized egg occurs outside the uterus.

Trial procedures have taken place in India, Bangladesh, Vietnam, Chile and Indonesia. Mulay argues that the rural women involved are often uninformed that they are part of an experiment, as may be those collecting the data.

Many of these countries do not have well-developed norms for medical experiments, or any overseeing govermental agencies. Mulay pointed out, "Follow-up trials are usually conducted by the original researchers, who have a vested interest in the outcome."

In 1994, the World Health Organization asked that trials cease until the toxicity of the treatment is known. Nonetheless, Mumford and Kessler "are quite vigorously continuing to promote QS." Despite WHO's edicts, "they want a trial to take place in the United States," Mulay said in a follow-up interview.

Mulay's criticisms have been noted by quinacrine's proponents. In the online Quinacrine Newsletter, Mumford accuses Mulay of "wholesale character assassination."

He argues that deaths related to quinacrine were connected to the "slurry" method of administering the drug, not the pellet method he and his team have been using. He argues that Mulay doesn't make enough of a distinction between the two, creating a false impression that the pellet method is under a cloud.

He also brushes aside WHO's reservations, contending that the organization is heavily influenced by the Vatican which opposes almost all methods of birth control.

Mulay organized an international workshop of women's health advocates last December to form a research team to conduct a scientific, objective study on the effects of QS.

The team will pursue their research in India, where, thanks to access to public interest litigation, women launched a lawsuit to ban QS. Although the suit was successful, the ban has not been properly implemented and private doctors still offer the procedure.

Mulay wants to document the process surrounding clinical trials of QS. Her team will look at the approval process, norms, practices and methods of informed consent (difficult to obtain where literacy is poor) and assess the human rights implications.

The group's pilot study will take place this fall in West Bengal, where 25,000 women have been sterilized using quinacrine. After using the pilot project to fine-tune their research methods -- Mulay wants to ensure that the questions posed to women are not leading in any way, for instance -- they will cast their net in a much wider fashion.

Once their tools are set, the team plans to interview 2,500 women, half to have undergone QS, half to have received surgical sterilization. Her research team includes local physicians who have performed surgical sterilizations, and have seen the effects of QS.

Mulay is hoping that a "scientific approach will convince physicians" that QS is not the only alternative.

"The real problem with surgical sterilization [in India] is the conditions under which it's done. Also the kind of [outdated] instrumentation," Mulay said. She believes it is also necessary to improve the conditions for these procedures and make them more widely accessible.

Mulay also wants to convince doctors that "women should be part of the decision-making process," and force them to ask, "Is sterilization the best way to promote family planning?" It is usually not -- by the time a woman seeks to be sterilized she already has four or five children. "Other kinds of contraception must be looked at."

For Mulay, designing the questionnaire has been the biggest challenge. The process took close to a year and "it was very tricky." She later said, "You want to be sure you don't influence them to give the response they think you want to hear." For she wants the international medical community to hear these responses loud and clear.

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