Like having herpes wasn't bad enough, now this: A Washington, D.C.- and Austin-based watchdog group is alleging that Parkland Hospital and the University of Texas Southwestern Medical Center at Dallas endangered the health of low-income pregnant women -- and the lives of their newborns -- when they let a drug company experiment on them by giving them placebos rather than drugs that might have actually, ya know, helped them. (Really, why was this not a front-page story over the weekend?) In the December edition of the journal Obstetrics & Gynecology, representatives from Public Citizen -- including an obstetrician at the University of California-San Francisco and another one from the University of South Florida -- write that from April 1998 to November 2004, "dozens of primarily indigent pregnant women enrolled in a drug-company sponsored research trial were needlessly put at risk by being treated with a placebo rather than a generic drug proven to help them."
The initial study, which was paid for by Glaxo-Wellcome (now GlaxoSmithKline) and conducted by UT-Southwestern researchers, ran in the July issue of the medical journal, the official journal of the American College of Obstetricians and Gynecologists. The point of the study was to see how well a drug called valacyclovir (or Valtrex, as it's commonly known) did with in reducing the outbreak of the genital herpes simplex virus (HSV) lesions during childbirth. A baby born during an outbreak can die if it's affected, and Public Citizen -- whose Health Research Group runs the database containing information about more than 500 kinds of prescription drugs, including more than 200 considered "unsafe or ineffective" -- says Glaxo knew these HSV-infected women could suffer an outbreak during labor. The only way to protect them, and their newborns, was to offer either the real drug itself or to allow docs at Parkland to perform Cesareans. About 170 women got Valtrex; the same amount got the placebos. And it's those 170 women with which Public Citizen has concerned itself.
As far as Public Citizen's docs are concerned, at the very least those women should have been given a drug called acyclovir, which, they write, "significantly reduced Cesarean rates for women with both first and recurrent episodes of HSV compared to a placebo." To give them nothing, well, they believe that to be nothing less than irresponsible. "Indigent pregnant women represent a particularly vulnerable population," says Dr. Aaron Caughey in the Public Citizen press release. Caughey's an obstetrician at the University of California, San Francisco, and the lead author of the letter. "That a research trial could be performed that put pregnant women at risk when an effective medication was available flies in the face of responsible medical research."
The Associated Press moved a story on this Friday; it was picked up in dozens of papers. The Dallas Morning News ran a story on Saturday -- on page A16, which is why you missed it -- in which researchers involved in the study say they did nothing wrong...something about proper safeguards being in place, etc. After all, GlaxoSmithKline's motto is: "Do more, feel better, live longer." You believe that, don't you? Now, take this pill and lie back. There, there. You feel better already, don't you? --Robert Wilonsky