Father of terb pump publishes new study


Despite FDA warning on pump, retrospective study compares it to pills

Updated 3/5/01

Dr. Fung Lam, who pioneered the use of the terbutaline pump, has published a new study (Journal of Perinatology 2000, Vol. 20, pp. 408-413). The study retrospectively examined the records of women who had been pregnant with twins and had received terbutaline pills for preterm labor and then had later been switched to the terbutaline pump. The study compared the lengths of time that these women received each form of terbutaline and found that women were on the pump longer before another episode of preterm labor and or delivery. The study says the average "pregnancy prolongation" was 19.3 days plus or minus 15.3 for women taking terbutaline pills and 34 days plus or minus 19.8 days for women on the terbutaline pump.

The study fails to mention at any point that the FDA warned doctors in 1997 that the terbutaline pump was neither safe nor effective. The FDA reaffirmed its position on the terbutaline pump in 1999. The study also does not mention any side effects associated with terbutaline. Carrying twins can put women at greater risk of side effects from preterm labor drugs.

The study authors state they did not use a double-blind placebo-control, which is considered the gold standard for research. A 1998 study that did use a double-blind trial found the terbutaline pump works no better than a placebo. The authors say the study was not designed to test the safety or effectiveness of terbutaline as maintenance therapy for preterm labor.

The study also seeks to compare two forms of terbutaline delivered to the same women at different points in their pregnancies. Most studies that compare different forms of a drug, administer them at the same time to different groups of women and conduct the comparison on that basis.