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    • THE BABY BUSINESS

    Some say it's time to regulate a growth industry: fertility clinics

    MEDICINE: Breakthroughs have given new hope to childless couples but created a field open to abuse.

    May 18, 1995

    MICHELLE NICOLOSI
    THE ORANGE COUNTY REGISTER

    It's been 16 years since headlines sang with news of the birth of "test-tube baby" Louise Brown, the first child created by in-vitro fertilization.

    Suddenly, women with no chance of giving birth had new hope: Eggs could be plucked from ovaries, fertilized in a glass dish to make embryos, then planted in the womb.
    Now, a medical specialty that offered few options for the infertile had a new procedure to offer clients desperate to have a child -- and often willing to mortgage their homes for one.

    IVF led to a spate of new discoveries and treatments, so that by 1994 the baby business had grown to a $2 billion industry, full of promise for would-be parents but also rife with problems so vast many are crying for legislation to keep it in line.

    "Technology is outrunning our laws and it also is outrunning our ethics," said Leslie Wolfe, head of the Center for Women Policy Studies in Washington, D.C.

    Because no training is required to do IVF, many physicians do the procedure with little experience. Fewer than 600 doctors are certified reproduction endocrinologists who have completed fertility fellowships; about half of the gynecologists listed in local telephone yellow pages claim to be fertility specialists or to do fertility treatment.

    Because the law doesn't regulate how clinics report success rates, patients can be misled with doctored statistics. "I can manipulate the hell out of numbers, and anybody can," said Dr. David Olive, head of Yale University's fertility clinic.

    The new technologies have caused remarkable growth: In 1985, there were 30 in-vitro clinics in the United States. Today there are more than 300.

    In 1968, an estimated 600,000 visits were made to fertility clinics. By 1988, that figure had more than doubled to 1.3 million.

    IVF has improved, too: Success rates for infertile women younger than 40 are up to 40 percent at some clinics, as practitioners learn how better to culture embryos in-vitro. Nationally, on average 15 percent of treatment cycles started end in a live birth.

    And the procedure has become more convenient: Once done as major surgery requiring general anesthesia, it now can be performed in the office under local anesthesia and without surgery.

    Today, in addition to IVF there are GIFT and ZIFT, which put egg and sperm (GIFT) or embryos (ZIFT) into the fallopian tube -- instead of into the uterus, where IVF places them.

    Instead of just the one fertility drug available in the early 1970s _ clomiphene citrate _ now there's a dizzying array: HMG, HCG, GnRH analogs, all of which flick various hormonal switches in an effort to cause ovulation.

    If a patient's sperm are having a hard time breaking through the egg's protective coating, surgeons can drill a tiny hole in the egg and drop the sperm in.

    Worried your child might have a genetic disorder? Scientists can test your embryo before they implant it. If there's something wrong with it, they simply don't implant it.

    And doctors can freeze embryos for later use. Soon, they hope to be able to store unfertilized eggs, so a woman can save them at age 25 and use them to start a baby long after she goes through menopause and stops producing eggs.

    Before in-vitro, "there were very rudimentary treatments" for infertility, said Dr. Sam Marynick, co-medical director of the Baylor Center for Reproductive Health in Texas.

    Since the introduction of in-vitro, things have never been the same.

    "There seems to be this enormous leap forward every year in terms of discovery," Wolfe said.

    But many worry that the lack of laws governing the practice of in-vitro fertilization is leading to problems.

    For example:

    Some generalists are unwilling to pass the profits of infertility patients on to specialists. They often try to treat patients they haven't the expertise to help.

    "That's certainly true," said Dr. Mark Sauer, associate professor of obstetrics and gynecology at USC School of Medicine. "If you just flip through the yellow pages, half the OB/GYNs" claim to do fertility treatments because it's a big-money business, he said.

    "Infertility represents a lot of patients (and) a lot of money."

    The unwillingness to refer patients to specialists may have cost some women their chance to have a baby, Sauer said.

    Sherron Mills, nurse practitioner at Pacific Reproductive Services, a sperm bank in San Francisco, agreed delay "could mean she never gets pregnant because she's exhausted her ovarian reserve. That's tragic."

    Because no one monitors clinics' claims, "the public is frequently duped" by misleading advertising, Olive said.

    A federal survey of clinics in the late 1980s found that about half of the 200 then in business had never produced a live birth.

    The clinics weren't telling patients they hadn't succeeded, said Lori Andrews, a Chicago Kent College of Law professor considered one of the nation's top experts on the subject.

    "They would use overall national statistics; some would use the success rate of another clinic," Andrews said.

    The Federal Trade Commission has cracked down on at least six IVF clinics, charging them with "false and misleading

    representation" and ordering them to stop.

    And Congress passed a law in 1992 requiring clinics to report success rates to the Centers for Disease Control and Prevention. The law was supposed to take effect this year but the reporting program hasn't been set up yet because of lack of funding, CDC spokesmen said.

    To break even, the average clinic must do $500,000 in business a year, Olive said. The pressure to make a profit means some clinics push patients toward more expensive treatments before trying the first line of less costly methods, experts said.

    "I'm sure there are some that do" push for expensive treatments to make more money, Sauer said. "I wish that wasn't the case, but money speaks very loudly in American medicine. It would be naive to think" otherwise, Sauer said.

    Infertility care rarely is covered by insurance, which means there is less paperwork and less bureaucracy to burden clinics. One fertility series can cost up to $10,000.

    "If you're dealing with a cash-up-front patient population, you get your payment up front," Sauer said. "Your money's right there, in the bank."

    Because the industry has sprouted so quickly and technologies develop so rapidly, there is no standard way of doing even the most basic drug treatments or procedures.

    Critics complain experimental procedures often are offered to the public even before they've been proven in clinical trials.

    For example, a new device that may allow doctors to put embryos, eggs and sperm into the fallopian tube without major surgery is the subject of a experiment Olive hopes to start soon. At least one San Francisco clinic isn't waiting for study results: It's already offering the procedure to clients.

    There's no law to prevent doctors from trying out procedures before they've been tested, and few laws governing the industry at all.

    The regulation void means "patients are much more likely to be exploited" here than in countries such as Britain, which monitors clinics, said Dr. Robert Winston, professor of fertility studies at the University of London.

    Many fertility experts agree the industry has problems but oppose government intervention and regulation, saying politicians inevitably regulate the wrong things.

    Because laws likely would be ineffective or misguided and because most of the fertility practitioners are honorable, many doctors say the industry should be self-regulated, not constrained by laws.

    Andrews and others disagree, saying many abuses, from misleading advertising to the recent case in Virginia in which a doctor fertilized patients with his own sperm, illustrate the need for legislation.

    "This industry deals with very desperate patients. It is not as accountable as other segments of health-care providers" because few patients sue fertility doctors for malpractice, Andrews said.

    Olive agreed "the problem with fertility is ... patients don't sue. They come in infertile and leave infertile and assume the doctor did his best."

    To reach Michelle Nicolosi, call (714) 953-7967.

    (SIDEBAR)

    TIPS ON CHOOSING A GOOD FERTILITY SPECIALIST

    Experts recommended you ask lots of questions when shopping for a fertility doctor. Ask what the doctor's success rates are per cycle started. In other words, each time they launch a woman into the process by starting her on drugs, what are the chances she'll give birth?

    "Before you agree to any course of action, make sure your gynecologist had adequate training and experience in fertility," write the authors of "Take This Book to the Gynecologist With You, a Consumer's Guide to Women's Health."

    "How many couples has he treated and for what? How many babies has he produced? If he suggests he can do a certain test or procedure, ask how many times he has done it and his complication rate."