2. The FDA regulations overlooked the usual scientific safeguards used in clinical trials. For example, while the trials used sonograms to determine the age of the fetus, FDA regulations have not required an ultrasound before usage -- even though the drug is not recommended for pregnancies beyond 49 days' gestation and it does not terminate ectopic (fallopian-tube) pregnancies. Whether or not Holly Patterson had an ectopic pregnancy is a crucial factor in investigating her death. In a previous case, an American woman bled to death because of a ruptured tubal pregnancy that wasn't distinguished from the normal heavy bleeding typical of an RU-486 abortion.
3. The FDA failed to test the drug on adolescents like Holly Patterson -- even though they represent a target market, since clinics advertise it as an abortion method that increases privacy. No doubt Holly thought RU-486 was preferable because it evaded a surgical procedure.
4. The FDA normally requires that the selection of patients in a drug trial be random, that some patients receive a placebo to create a control group, and that participating physicians are not told who is and is not receiving the actual medication. In the FDA's supposedly scientific trials for Mifeprex, the selection of subjects was not random, and no one received a placebo.
This petition was ignored by the networks. But they also ignored Danco's admission to the FDA in April 2002 that no less than 400 women suffered complications after using RU-486. Two women had died after using Mifeprex, one from that ruptured tubal pregnancy and one from a fatal bacterial infection. Canadian drug trials were halted when a participating woman died.
Holly's father, Monty Patterson, learned about the problem too late. He told the San Francisco Chronicle, "The medical community treats this as a simple pill you take, as if you're getting rid of a headache. The procedure, the follow-ups, it's all too lackadaisical. The girl gets a pill. Then she's sent home to do the rest on her own. There are just too many things that can go wrong."
Will anything happen to prevent more teenage girls from dying? Here are two reasons for pessimism: The FDA has no enforcement mechanism that requires Danco to share all the reports it receives on negative effects. And there is no greater supporter of unrestricted abortion in American society than that "watchdog" entity entrusted to shed light on this horror.
Healthcare Solutions Begin with Innovators in Tennessee, Not Bureaucrats in Washington, DC | Congressman Marsha Blackburn