Should pregnant women participate in trials to discover the effectiveness and potential side effects of new drugs?
This is a controversial topic, because participating in drug tests exposes pregnant women and their babies to possible harm.
After all, once approved, drugs go on the market, where doctors will prescribe them to many people across the board, including pregnant women in potentially large numbers, Macklin notes. If researchers haven't had a chance to see the effects of a particular drug on pregnant women and their fetuses, then drugs that cause damage might injure large numbers of people before an alarm is sounded.
We don't have to imagine such an event. Thalidomide, a multi-purpose drug introduced in Europe in 1957, was prescribed for morning sickness for pregnant women. It took four years for researchers to realize and then prove that the drug was causing devastating birth defects. More than 10,000 babies in 46 countries whose mothers had taken thalidomide were born with deformed, often truncated limbs.
"Had the drug been tested in very few women in a ... clinical trial, the mutagenic effect would more likely have been discovered and the number of babies born with deformities would have been much smaller," Macklin writes.
Various governmental bodies, including the U.S. Food and Drug Administration, have gone back and forth on whether to test drugs on pregnant women since it became known that drugs can cross the placenta and affect babies.
HIV-AIDS has forced the issue because not only will pregnant women likely take the drugs that are being developed to combat the fatal disease, but clinical trials also present an opportunity for infected women to obtain potentially life-saving treatment that has not been approved for general use. It is "essential" to include infected pregnant women in these trials, Macklin writes.
The Microbicide Trials Network, based at the University of Pittsburgh and Magee-Womens Research Institute in Pittsburgh, which is working to develop new treatments for HIV-AIDS, is doing just that. In a drug study now under way, MTN is retaining women who become pregnant, and is enrolling pregnant women as well, including healthy, HIV-negative pregnant women, Macklin writes.
However, researchers who enroll pregnant women in studies must "ensure that the informed consent process meets the highest standards," so the women who choose to participate in trials understand the risks to them and their fetuses, Macklin writes.
Image from "Pregnant Graffiti" by Petteri Sulonen