Critics Claim Indigent Pregnant Women Put at Risk
By Christine Cupaiuolo — December 4, 2006
Today we’ll look at some recently released health updates, but first some disturbing news concerning a study for the drug valacyclovir that some women’s health advocates claim put indigent pregnant women needlessly at risk. Andrew Bridges of the Associated Press explains the controversy:
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.
“We have long contended that if researchers and drug companies could get away with administering placebos under questionable conditions in developing countries, they would do the same to poor people in the United States,” Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group, said in a statement. “Now they have.”
The statement also includes remarks from Dr. Adam Urato, an obstetrician at the University of South Florida: “At the very same time these researchers were publishing their conclusion that acyclovir could reduce Cesareans, they weren’t offering this drug to these indigent patients. They were knowingly placing their patients at higher risk. Did the patients understand that the researchers themselves had concluded that acyclovir reduced the risk of Cesarean?”
The journal Obstetrics & Gynecology, which published the results of the study in the July 2006 issue, printed a letter in its December issue from Urie, Urato and Dr. Aaron Caughey, an obstetrician at the University of California, San Francisco. In the letter, the authors “called upon the University of Texas Southwestern Medical Center at Dallas, which authorized the study, to issue a formal apology to the pregnant women enrolled and to perform a full investigation as to what went wrong to allow such a trial to take place. They also called for compensation for the women involved in the trial who were not properly treated and underwent Cesarean sections,” according to Public Interest.
The letter also urges the American College of Obstetricians and Gynecologists (ACOG) and the journal’s editors to look into how the study was handled by the journal.