Dozens of poor and minority pregnant women were put at risk when they were given dummy pills instead of a drug believed to prevent outbreaks of genital herpes, consumer watchdogs charged Friday.
The researchers defended their work, saying in part the study was to assess the uncertain risks of the drug to the women's fetuses.
In the study, researchers at Parkland Hospital in Dallas gave 170 pregnant women the drug valacyclovir to see if the drug would reduce herpes outbreaks at birth. The virus can be fatal to newborns if infected during delivery. An additional 168 women from the largely indigent population the hospital serves were given dummy pills. More of those women went on to have Caesarean sections than did those given valacyclovir, which the body breaks down to form the herpes drug acyclovir.
Since the researchers had published a study midway through the clinical trial that concluded giving women acyclovir could reduce the C-section rate, critics allege they needlessly put half the women at risk by not giving them the drug instead of dummy pills.
"What I don't understand is how you can do a research study and conclude that a drug is effective and then stare a bunch of pregnant women in the face and withhold the very drug you've just recommended," said Dr. Peter Lurie, of the watchdog group Public Citizen.
Lurie and two other doctors leveled their criticism in a letter appearing this month in the journal Obstetrics & Gynecology. The journal published both the 2003 study by the researchers suggesting a benefit to treating women with acyclovir, as well a July 2006 study that concluded valacyclovir significantly reduced the outbreaks that lead to C-sections.
A doctor involved in the studies, Dr. George Wendel, would not comment specifically on allegations that poor women were taken advantage of. In an interview, he said the study was designed and conducted "according to good research practices" and approved by the hospital's ethics review board.
Wendel and his colleagues also published a rebuttal in the journal, saying in part that the study balanced the risks and benefits of valacyclovir to both the mothers and their fetuses.
Clinical trials of new drugs typically compare them with dummy pills — unless there already is an effective treatment available.
Wendel also said their 2003 work didn't conclude acyclovir should be recommended, only that more research was needed.
Since 1999, the American College of Obstetrics and Gynecology, publisher of the journal, has recommended acyclovir treatment be considered late in pregnancy for women who suffer their first genital herpes outbreak while pregnant.
Acyclovir is widely available in generic form. Valacyclovir is sold as Valtrex by GlaxoSmithKline, which sponsored the 2006 study.