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DALLAS - A group of mostly poor black and Hispanic mothers with herpes were put needlessly at risk by a drug company-funded study at Dallas' Parkland Memorial Hospital, a public advocacy group said Friday.
The study, funded by GlaxoSmithKline and conducted by researchers at Dallas' UT Southwestern Medical Center, tested the drug valacyclovir's ability to reduce herpes outbreaks at birth and prevent the need for Caesarean deliveries.
In all, 170 pregnant women were given valacyclovir, sold under the brand name Valtrex. An additional 168 women were given dummy pills to compare the results.
Critics said Friday that in order to prevent outbreaks and risks at birth, the women should not have been given a placebo but instead a drug called acyclovir, which some studies have shown to reduce the risk of outbreaks at birth.
The study's senior author, George Wendel, defended the design and results of the work Friday, saying acyclovir's safety had not been definitively established for mothers and fetuses.
"This study was carefully designed and approved by the IRB (Institutional Review Board) for the campus and reviewed every year for its conduct and had safeguards built in," he said.
"I think it was one of the first studies that actually had some information ... that outlined some attempt to address the safety issues in a rigorous fashion in those that were given the drug compared to those given placebos."
The study, published this year in the journal Obstetrics & Gynecology, showed that just 4 percent of women who received Valtrex needed a C-section compared with 13 percent in the group that received dummy pills.
Source: http://www.thestate.com/mld/thestate/living/health/16150814.htm
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