Fast Spread of Test-Tube Baby Clinics Spurs Growing Concern

The rapid and unregulated growth of high-tech conception in the decade since the birth of the world’s first test-tube baby is sparking growing concern that infertile couples are being exploited by proliferating in vitro fertilization clinics.

Newly released statistics show that nearly half the estimated 175 in vitro fertilization centers in the country have never produced a single baby. As a result, there is talk in Washington this summer of regulation of the burgeoning $66-million industry.

The new scrutiny comes amid reports of infertile couples being led to believe their chances of giving birth through in vitro fertilization are as high as 30%. Thousands of dollars later, and still childless, many such couples have learned that the average success rate per single attempt may be as low as 6%.

Labs Are Unlicensed

Critics say regulation of the business has become necessary in part because the medical community has failed to police itself adequately. In vitro fertilization laboratories are unlicensed, clinic certification is voluntary and there is no requirement for open reporting of results.

But some consumers, among others, argue that rigid rules could hamstring the industry at a crucial stage in its development. At a time of rising demand for infertility services, they say clinics would close, and both the industry and consumers would suffer.

“The IVF (in vitro fertilization) community and the medical field for the first time are sitting on the brink of mandated regulation, largely through our own inaction,” said Dr. Geoffrey Sher, founder of the first private, non-university-based in vitro fertilization clinic in the country. “ . . . I feel very, very strongly that it is time that we put our house in order--before somebody comes in and reorganizes it completely for us.”

Insurers’ Reluctance

The absence of oversight has been compounded by the reluctance of many insurers to include in vitro fertilization in health insurance coverage. As a result, the role of insurers in scrutinizing services and measuring rates of performance has been limited, critics say.

Nor has the federal government used the leverage inherent in its federal grants and contracts to ensure that consumers are protected. There have been no federal grants for research in the field in a decade because of unresolved ethical and political issues.

“There has been a total abdication of responsibility on the part of the government at the level of the Department of Health and Human Services,” said Gary Hodgen, a fertility researcher who left the National Institutes of Health in frustration with federal policy.

Today, a congressional subcommittee is scheduled to hold a hearing in Washington on the extent of exploitation of infertile couples, as well as on emerging reproductive technologies and the ethical questions they raise.

The House subcommittee on human resources and intergovernmental relations will also examine the failure of successive administrations to reappoint a federal ethics advisory board whose approval would be needed before any federal grants in the area could be awarded.

The subcommittee is the second in six weeks to begin looking at the in vitro fertilization business.

Currently, about 2 to 3 million couples in the United States are infertile, according to the most recent federal statistics available. Although the incidence of infertility appears stable, the number of office visits for infertility services nearly tripled between 1968 and 1984.

Of those couples seeking treatment, about 85% receive conventional medical and surgical therapy, including use of fertility drugs and artificial insemination. For the 15% for whom traditional therapies are ineffective, in vitro fertilization is one of several new technologies offering hope.

Has Other Uses

For example, the technology is sometimes used in patients with blockages of the Fallopian tubes that cannot be cleared surgically. It can also be used for women with endometriosis, a condition in which tissue lines the uterus and can prevent sperm from meeting the woman’s egg.

During in vitro fertilization, a woman is stimulated with hormones to produce eggs. Those eggs are then collected and incubated with sperm in a laboratory. If fertilization occurs, so-called pre-embryos are transferred back to the woman’s uterus, using a small catheter.

An estimated 5,000 babies have been born through in vitro fertilization worldwide since the July 25, 1978, birth of Louise Brown, the first test-tube baby. In the United States, the American Fertility Society counts 175 in vitro fertilization centers or clinics; some physicians believe there are more.

Yet in many ways the procedure remains experimental.

“IVF is as much an art as a science,” said Sher, medical director of the Pacific Fertility Center in San Francisco. “There’s a lot of voodoo that we don’t understand. We’re not familiar with all the variables that impact on success.”

As a result, success rates vary widely from clinic to clinic.

Report Anonymously

The first data ever published on the program’s success rates appeared earlier this year in the fertility society’s journal. Only 41 of the then-existing clinics reported their success rates for 1985 and 1986, all on an anonymous basis.

According to those data, the average chance of becoming pregnant after a successful embryo transfer was 17%. But because of the high risk of miscarriage, stillbirth or pregnancy in a Fallopian tube after the procedure, the chance of actually having a baby was only about 11%.

And because many women fail to produce eggs after the initial hormone stimulation, and do not go on to successful embryo transfer, the overall chance of producing a baby after a single attempt was 6%.

The best centers report live birth rates as high as 12% or perhaps 15%. But physicians noted that any clinic’s success rate must be judged in the context of the age of its patients; a large percentage of clients over 40 will lower the success rate.

Currently, clinics are not required to report their results. Reporting to the fertility society’s registry is voluntary and anonymous. There is no central resource to which consumers can turn to learn their chances of conceiving through a particular clinic.

Some Say They Were Misled

Without such a resource, couples say they have been misled. Some report having been quoted supposedly nationwide success rates, sometimes as high as 30%. Some clinics simply give out pregnancy rates--omitting to mention that actual birthrates are much lower.

“The reporting of IVF data is limited only by one’s imagination in contriving some new yardstick of performance, short of a normal, live-born child,” stated a report on infertility published in May by the congressional Office of Technology Assessment.

Many other parts of the process are also unscrutinized.

There are no mandatory standards that a fertilization clinic must meet; there are simply guidelines to be met for voluntary certification by a branch of the fertility society. Less than half the clinics operating in the country have received that certification.

Nor are there licensing requirements for the so-called culture labs where fertilization takes place. Other medical laboratories must meet state guidelines for personnel and processes, but in vitro fertilization labs have yet to come under state scrutiny.

“We have . . . a lab that has produced almost 300 babies,” said Dr. Richard Marrs, director of the Institute of Reproductive Medicine at the Hospital of the Good Samaritan in Los Angeles. “The Department of Health Services doesn’t have any idea that it even exists.”

Crucial First Step

But there is little agreement on the best way of overseeing the industry.

Many critics, including Marrs, who pioneered in vitro fertilization on the West Coast, say that laboratory licensing is a crucial first step. He and others have suggested to Congress that an advisory panel be formed to draw up laboratory standards that might be enforced nationwide.

They have also called for mandatory reporting by each center of rates of pregnancy and successful births. State medical licensing boards or federal health officials could mandate such reporting, Marrs said, because no professional society has the power to do so.

Finally, many say there should be more aggressive accreditation of the physicians who run the clinics. Insurance companies could assist in enforcement, some suggest, by pegging reimbursement to the reporting of clinic data and certification of staff.

Many also want more federal involvement in research and financing.

Currently, all federally financed biomedical research must be conducted according to federal guidelines. Those include the requirement that research on human subjects be reviewed to ensure that risks are minimized and that subjects give their informed consent.

Federal Board Disbanded

But there has been no federal involvement in research on human embryos and fetuses because there have been no federal grants, scientists said. There have been no grants because the federal ethics board that must pass on such research has been disbanded since 1980.

As a result, scientists say they have received no federal financing for research involving the fertilizing of human eggs with human sperm. They say the absence of financing has dramatically affected their ability to pursue improvements in in vitro fertilization.

“There has been a de facto moratorium on federal funding of human in vitro fertilization,” Gary Ellis of the Office of Technology Assessment said in an interview. “ . . . I think it’s fair to say it was a political hot potato.”

As a result, Ellis said, federal health officials estimate that each year as many as 100 grant applications to do research relating to in vitro fertilization are not submitted for federal funding. “We termed that a chilling effect, a blockade,” Ellis said.

Although there appears to be broad support within the medical community for increased federal financing and research, many physicians oppose government regulation. Even some consumer groups say they worry that regulation could hurt consumers.

Fears Spread of Regulation

“I’m a strong opponent of mandated regulation in medicine,” said Sher, who supports voluntary reporting and accreditation reinforced by insurers. “Because if it starts with IVF, it can end up with face lifts, Caesarean sections and removal of warts.”

“If we punish all the clinics that are fibbing about their results, they’ll all get sued or shut down and we’ll end up with too few clinics and incredible waiting lists,” said Gina De Miranda, whose Texas-based consumer group has become active in the area of in vitro fertilization.

The De Miranda Institute is recommending that a congressionally mandated task force representing physicians, consumers and insurers draw up standards under which the most successful clinics would be certified and others could operate as “apprentices.”

The apprentice clinics would charge less than the current $4,000 to $6,000 per attempt while working toward certification. Consumers could opt for a less expensive service, knowing that their chance of giving birth was also lower.

“Right now, 169 clinics are operating independently, not talking to each other or exchanging information,” said Carol Peters, who is working on the proposal. “And the person who knows least about all of it is paying the most--the consumer--for something that in some cases may be experimental.”