Uterine monitoring: more profitable than effective?

The Tokos Medical Corporation, which sells a service that detects early labor in pregnant women, recently started a program to reward obstetricians who ordered it for their patients. In its files the company called the program "Dr. Deal." The deal: earn up to $20,000 annually on an investmeot of $1,000.

The program, in which 300 to 400 obstetricians nationwide are participating, works likes this: The doctors put up $1,000 each to become shareholders in a company set up by Tokos that typically exists only on paper. In return, the doctors pocket 15 percent of the payment for any Tokos services prescribed by members of the physician-owned company. Tokos says participating physicians currently average about $5,000 a year from the arrangement; literature from one Tokos subsidiary boasted that annual earnings could reach $22,500.

When doctors do prescribe it, Tokos's home-monitoring service is not cheap. It costs $100 to $300 a day, or about $5,000 a pregnancy. That's a hard sell among cost-conscious insurers, so Tokos has 20 employees who make the company's case-and they have had increasing success in persuading insurers to pay.

But a debate is growing about the effectiveness of the home uterine monitor that is the keystone of Tokos's service. The Food and Drug Administration is also investigating Tokos's marketing claims. Separately, there is a scientific controversy about the safety of the drugs Tokos sells to prolong pregnancy.

Some doctors are concerned about not only Tokos's marketing practices but also the willingness of some physicians to take part in its investmeot plans. "It is a sad day for medicine," said Dr. Benjamin Sachs, chief of obstetrics and gynecology at Beth Israel Hospital in Boston.

A look at Tokos's marketing efforts highlights one of the most troubling issues in health care: Medical companies often go to great lengths to encourage doctors to use their products, and to persuade insurers to pay for them. And they can succeed even when significant questions exist about a product's efficacy and safety. Health care experts say that nothing will change-and medical costs will never be satisfactorily controlled--without a systematic effort, whether by the Governmeot or the private sector, to study medical technologies and identify who will most benefit from them.

Fouoded in 1983, Tokos is the leading company in a burgeoning industry that has sprung up to preveot premature births, a leading cause of birth defects and infant mortality. Each year 6 to 8 percent of infants are born prematurely (defined as before the 37th week of gestation), some so early that they die or suffer crippling defects. A troubled pregnancy can be devastating. And associated medical costs can reach $1 million. Doctors cannot predict early delivery, though women carrying more than one fetus or having a history of early labor are considered to be at greatest risk. And though women can be trained to recognize some signs of early labor, home monitoring detects contractions a woman may not feel. Also, a physician who might have hospitalized a woman for early labor--at $500 a day--now may have a cheaper choice.

The use of home monitoring of pregnancies is growing sharply. Last year, Tokos, which controls about 65 percent of the market, treated about 25,000 patients, a 25 percent increase from 1991. Through the first nine months of 1992, the company had reveoues of $124 million.

To use the Tokos monitor, a woman straps arouod her abdomen a belt containing a sensor that detects uterine contractions. The hourlong reading is made one or more times a day and is transmitted by telephone lines to one of 60 Tokos offices staffed by nurses who analyze the data. Should the data suggest that the woman is experiencing early labor, a Tokos nurse calls her physician, who may prescribe terbutaline or ritodrine, medications dispensed by Tokos in a home infusion kit, to relax the uterus. A single monitor reading is $100 a day; additional readings and drugs raise that to $300. Visits by a Tokos nurse, required in the most serious cases, cost extra.

But does the Tokos technology itself--the devices that transmit data on uterine activity to the nurses--have any benefit beyond a psychological one in producing healthier babies? That is the nub of the dispute. Much of the research both pro and con has come uoder attack as scientifically flawed. Last year, the American College of Obstetricians and Gynecologists declined for the second time to recommend the routine use of home pregnancy monitoring for high-risk patients. The group cited, among other things, a lack of clear research showing benefits.

Also, a study by a Canadian team published last year in The New England Journal of Medicine suggested that ritodrine is not effective and in fact can cause health problems like maternal heart arrythmia, and, in rare instances, death. The other drug used by Tokos, terbutaline, is chemically similar to ritodrine.

For all the debate, the question of whether Tokos's monitor is worth the price may never be adequately answered. What is needed, many people say, is studies that separate the benefits provided by the monitor from those offered by talking with a nurse.