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Women's Health

When Does Assisting Fertility Clients Become Experimentation?

Reproduction: Some experts question the ethics of an unregulated industry that sometimes gives a vulnerable patient group only part of the truth.

March 30, 1998|RICK WEISS | THE WASHINGTON POST

Stacie McBain was just 20 last fall when doctors told her the cancer treatment she needed would leave her infertile. But there was hope: an $11,000 experimental procedure in which researchers would remove pieces of her ovaries and freeze them for later use.

The novel approach was not guaranteed to work. But McBain jumped at the opportunity after the doctors running the experiment told her that animal studies had been successful.

"I love kids and I always wanted to have them," McBain said in a recent interview. "They said they'd tried it in sheep and it worked."

What she and her parents were not told, however, was that only one sheep has ever become pregnant by this method.

That kind of omission would be unusual in most medical research settings. Yet by fertility clinic standards, several experts agreed, McBain was relatively well-informed; she at least was told she was part of an experiment.

Fertility clinics receive no government funding, so the women who use them are not covered by federal laws that protect human subjects in research. And although doctors in all types of medicine have the prerogative to try novel techniques that may help their patients, reproductive technology is evolving so fast that the line between cutting-edge medicine and using women as guinea pigs is no longer clear, observers say.

"We have in many respects far better protections for hamsters than for human fertility patients," said R. Alta Charo, a professor of law at the University of Wisconsin and a member of the National Bioethics Advisory Commission, which is investigating abuses of human subjects in research.

"We can tell you how many swabs are used on animals in a year in this country, but we can't tell you how many people were involved in fertility research in this country or how many adverse events there were or anything," Charo said. "We require all of that for nonhuman animals, but not for people."

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Unlike the high-profile legal cases that have emerged recently in the reproductive technology arena--dramatic cases of embryos placed in the wrong women or of babies created from dead people's sperm or eggs--abuses of research subjects in the fertility field remain largely invisible. The scope of the problem remains unknown, since there is no system of oversight.

But more than 1,000 women undergo in vitro fertilization procedures every week in this country, and countless others receive other kinds of fertility treatments. And at least some of the recent exciting breakthroughs in reproductive medicine, critics say, have been the result of ethically questionable practices, in which women served as subjects in ill-defined research projects or their eggs or embryos were sidetracked to laboratories without the donors' knowledge, to be used in experiments and eventually tossed in the garbage.

Fertility doctors say they are just trying to give women the best odds of getting pregnant. Patients want nothing less than the latest technology, they say, even if it is still experimental. And, they argue, since the federal government has decided not to fund fertility research, it is up to the private sector to conduct that work.

"Many patients feel they have the right to the most innovative treatment around, especially since a lot of them are paying out of pocket," said Mark Sauer, chief of reproductive endocrinology at Columbia-Presbyterian Medical Center in New York.

Others, however, say the lack of regulations over fertility research makes it too easy to cross the line from assistance to experimentation--especially since these patients' urgent desire for a baby makes them susceptible to exploitation.

"It's an extremely vulnerable patient group," said Gary Ellis, director of the office for Protection From Research Risks at the National Institutes of Health. "Desperation reigns."

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McBain's ovarian preservation procedure is a case in point of how difficult it can be to tell the difference between modern reproductive medicine and unregulated human research. Like many of the country's larger fertility clinics, the Fairfax, Va.-based Genetics & IVF Institute, where the procedure was done, has voluntarily instituted many of the protective measures required of researchers at federally funded venues.

The clinic had McBain sign a consent form, for example, that says in part "we cannot guarantee that you will benefit" from the procedure. Yet accompanying materials refer to "extraordinary results" in sheep and call the experimental procedure "a revolutionary improvement" in fertility preservation for women with cancer.

Such mixed messages are at best confusing and at worst unethical, but are not uncommon in the fertility arena, says Lori Andrews, a professor of law and bioethics at Chicago-Kent College of Law. "Patients are being told they're getting the latest clinical evaluation and treatment, but they're rarely told that there have only been, say, three births before."

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