Uterine Monitor Ineffective, Says Panel of Doctors
A device manufactured by Tokos Medical Corp. to monitor pregnant women subject to early deliveries at home fails to prevent premature births, costs too much and should never have been approved for routine use, a group of five obstetricians contends.
In a report published in today’s New England Journal of Medicine, the doctors criticized the U.S. Food and Drug Administration for approving the device in September, 1990, without proof that it actually lowers the risk of delivering too early.
The device, called the Genesis home uterine activity monitor, is intended to detect pre-term labor so it can be stopped. Since the FDA approval, the device has been used by more than 75,000 women, according to Tokos.
“A lot of people feel this device is unproven, and we need as physicians to monitor the technology we’re using,” said Dr. Benjamin P. Sachs, chief of obstetrics and gynecology at Beth Israel Hospital in Boston and principal author of the article. Most of the signers are prominent in the American College of Obstetrics and Gynecology.
He added during a subsequent interview that the expense of the device--$5,000 per pregnancy--diverts resources away from the more important issue of universal access to prenatal care. Also, there is no sure way to screen for risk of premature labor, Sachs said, and the treatment available for arresting early labor can injure the mother.
In an interview, Craig Davenport, president of Tokos, responded that the device was never intended to prevent pre-term labor, only to alert physicians to any danger. “It gives them a window into the home,” he said.
“The obstetricians have not been able to prevent this problem in the United States,” he said. “We’re not the answer, but we can be helpful to prompt intervention.”
He said Sachs’ cost argument is flawed because the expense of treating a prematurely born child is $30,000 on average and can reach $1 million. He agreed that current methods for selecting the women most at risk of premature delivery are imperfect.
Pregnant women use the Genesis home uterine activity monitor twice a day for an hour at a time to record contractions. The information is sent by telephone to Tokos’ central offices, where nurses look for early signs of premature labor. Generally, women use the device for 50 days, starting about the 25th week.
Candace Hurley, 37, a Laguna Beach resident, used the device while pregnant with both of her sons, who were born 12 months apart.
“Because I had the home monitor (during the second pregnancy), I was able to stay home with my baby,” said Hurley, who is involved in organizing a national support group for women who give birth prematurely and their families. “It’s like having a nurse at your side all the time.
“I can’t understand a challenge to this. Whoever is challenging this, if he was pregnant and would strap one on, he would feel a lot better.”
Pre-term birth is the leading contributor to infant mortality in the United States, which ranks behind 22 industrialized nations in infant mortality, officials say. Pre-term birth also contributes to lifelong disabilities such as cerebral palsy, mental retardation and multiple sclerosis.
Sachs said he first took the physicians’ letter to the FDA in January. He hopes to curb use of the device by alerting obstetricians to the controversy.
The letter, which was signed by one female physician, ran with companion responses from the FDA and Tokos.
Stock analysts said the challenge will have little effect on Tokos fortunes in the long run, though it may cause some initial confusion. The company’s stock fell $1.25 on the news yesterday, to $34.75 on NASDAQ.
The bulk of Tokos’ business is in leasing the monitoring device to physicians, said John Hindelong, an analyst with Donaldson, Lufkin & Jenrette Securities in New York. The company, which provides home health-care equipment and services, reported revenue of $82.3 million for the first nine months of this year and attributes most of a 40% revenue increase in the past year to business generated by the monitoring device.
Dorothy Ryan, senior health care services analyst with investment banker Robertson Stephens in San Francisco, said the volume of trading--more than 200,000 shares--is probably directly related to the Sachs letter.
“The FDA rarely writes in rebuttal,” Ryan said. “If anything, this will help (Tokos) in the long run; the (Sachs) article was so poorly put together. This will generate tremendous publicity.”
Tokos has been one of the year’s hottest health-care stocks, soaring from a low of $10.50 to a recent high of $38.50.
The company had submitted a similar device for approval to the FDA twice, but was rejected both times. In September, 1990, Tokos purchased a company which had a device that was about to win FDA approval--Physiologic Diagnostic Service of Atlanta--for $31.4 million.
In a clinical trial of 377 pregnant women finished in August, 1989, the PDS device alerted physicians to possible early delivery in 43 women. Intravenous drugs and hospitalization were then prescribed, according to one of the study’s authors, Dr. Shiraz Sunderji of St. John’s Mercy Medical Center in St. Louis.
Compared to the women who were not monitored, the 43 women delivered their babies an average of 1.7 weeks later, Sunderji said. The babies were heavier and required an average of 10 days in the intensive care unit, as opposed to 25 days for the babies in the un-monitored group. FDA approval was based on Sunderji’s study.
The Associated Press contributed to this story.
