T-Pump Therapy Undergoing a Close Second Look
Any woman who experiences preterm labor these days may find herself smack in the midst of a rare contest of wills among several consumer health groups, each of which claims to protect women’s health rights.
The issue is over the drug terbutaline and its use to quiet preterm labor via an infusion pump that can be used at home.
Terbutaline has been used by obstetricians for two decades to delay childbirth when uterine contractions begin before the 37th week of gestation--a condition that occurs in about one of every 10 births.
The medication is considered valuable, in part, because there are so few options to halt labor once it begins. Preterm labor causes at least 75% of newborn deaths that are not related to congenital malformations. Premature birth is associated with a higher risk of congenital developmental delay, visual and hearing impairment, chronic lung disease and cerebral palsy.
The problem is that terbutaline was approved by the Food and Drug Administration long ago for the treatment of asthma. And while doctors may prescribe medications for any purpose they see fit, according to a 1995 report from the American College of Obstetricians and Gynecologists, there are no scientific studies that clearly establish the effectiveness or safety of terbutaline therapy--especially the kind that women receive at home using a subcutaneous pump (sometimes called T-pump therapy).
Terbutaline is also administered orally and intravenously in a hospital.
FDA Safety Concerns
The FDA abruptly reversed its position last year and warned doctors that the safety and effectiveness of T-pump therapy at home has not been established.
The action satisfied one prominent women’s health group but has outraged obstetricians and scores of families who say their babies were born healthy due to terbutaline therapy. An estimated 24,000 women received T-pump therapy from 1987 to 1993, according to Dr. Roger B. Newman, director of maternal-fetal medicine at Medical University of South Carolina. Terbutaline therapy delivered in all forms is prescribed for an estimated 260,000 pregnant women each year.
“Women are treated in the hospitals with [intravenous] terbutaline and get higher doses, and then they are sent home to lie down and cross their fingers,” says Phipps Cohe, a spokeswoman with the High Risk Pregnancy Task Force, a nonprofit health group critical of the FDA’s action. “We had a rush to judgment on the part of the FDA without benefit of any further scientific review of this drug.”
Observers believe the FDA position rested heavily on a 1995 report from the American College of Ob-Gyn. While acknowledging that rates of preterm labor have hardly improved over the last 40 years, the statement suggested terbutaline--which is thought to relax the uterine muscles to resist contractions--is not necessarily the answer.
“Despite the widespread use . . . this approach has not been evaluated extensively, particularly in singleton gestations,” the ACOG statement noted.
The statement also warned of the risk of side effects from terbutaline, which includes rapid heart rate, anxiety, nausea, insomnia, tremors, chest pain, palpitations, high blood pressure and pulmonary edema.
But fears over terbutaline may date back to 1992 when a woman pregnant with twins died suddenly while on T-pump therapy at home. The death caught the eye of the National Women’s Health Network, a consumer protection group based in Washington.
The network filed a Citizen Petition to ask the FDA to alert doctors that T-pump therapy has not been shown to work and is possibly dangerous. In November 1997, the FDA concurred and notified doctors.
The FDA did not address oral terbutaline therapy or IV therapy administered in the hospital.
Still, the FDA’s rebuke of the therapy has angered many doctors and patients.
“It is inappropriate to be petitioning the FDA to ban a drug and a delivery system that is believed by most obstetricians to be uniquely effective, is endorsed by numerous advocacy groups of women with high-risk pregnancies, is demanded by thousands of women who have experienced or will experience pregnancies at high risk for preterm delivery, and is clearly only rarely associated with serious cardiopulmonary effects,” Newman said, in a statement posted on a Web site belonging to the Triplet Connection, a consumer group supporting women with multiple-gestation pregnancies.
Various consumer groups have joined the High Risk Pregnancy Task Force in Washington to protest the FDA action. A campaign led by Cohe’s organization filed an opposing Citizen Petition in March in an effort to restore T-pump therapy. The petition is still pending, and the FDA has not commented on it.
Others Got Involved
The campaign has also generated more than 1,500 citizen letters to Congress in protest. Other women have complained that T-pump therapy is no longer covered by their insurers because of the FDA’s position. The protests have caught the attention of a handful of lawmakers, including Sen. Paul Coverdel (R-Ga.), who has asked the FDA to reexamine the issue.
Some physicians, too, are angered by the FDA’s reversal. A group of perinatalogists and obstetricians calling themselves the Terbutaline Strategy Group filed a scientific petition with the FDA in support of the therapy.
“The risk of this type of therapy is the same or less than [hospital terbutaline] therapy. It’s not safer; there are potential complications. But certainly no more than [have] already been reported,” said Dr. Fung Lam, a member of the Terbutaline Strategy Group and a clinical professor at UC San Francisco who helped develop the T-pump. “Physicians like myself are deciding to use it, so they must be seeing efficacy. Tens of thousands of women receive it. If it didn’t work, nobody would use it.”
In data presented at a medical meeting earlier this year, Fung said that subcutaneous T-pump therapy had a 63% increase in prolonging pregnancy compared with the oral therapy.
But studies such as Fung’s are not convincing, says Cindy Pearson, executive director of the National Women’s Health Network.
“Yes, terbutaline via the pump seems to be better than terbutaline orally. But that doesn’t answer the very basic question of ‘Is terbutaline after the second or third day or so better than nothing at all?’ ” she says. “Still, I can empathize with women who are absolutely convinced that [personal experience] is all the proof they need.”
Women are frustrated by the lack of progress in treating preterm labor, both Cohe and Pearson agree.
“In the past 10 years there has been relatively nothing new being offered with regard to high-risk pregnancy,” she says. “If we could make a bigger difference in terms of prolonging pregnancy, we could look forward to better neonatal outcomes.”
Many health experts agree that a large study on T-pump therapy is badly needed; and, in fact, the idea has been on the agenda of the National Institutes of Child Health and Human Development without action for years, Newman says.
“When we ask ourselves if the [subcutaneous T-pump therapy] is really effective or if this unfortunate woman’s death was potentially a result of that therapy, the answer is that we really don’t know.”
