Hundreds given drug in controversial trials (Australia)

[Lunar Loops]

This from The Age:

Hundreds given drug in controversial trials

By Natasha Wallace
November 20, 2007

Hundreds of New South Wales women have been given a drug that may be implicated in serious birth complications but the state Health Department is refusing to release details on how many hospitals have used the controversial method of inducing labour.
It emerged yesterday that at Wagga Wagga Base Hospital alone, 250 women were involved in a trial using the stomach ulcer drug misoprostol to induce labour at full term, despite warnings against this by the manufacturer as early as 2000.
Other hospitals have used the drug for the same purpose, and one woman whose newborn baby died at the Sydney Royal Women's Hospital in 1997 fears she was experimented on without her consent.
The family of a six-year-old boy born with cerebral palsy has successfully sued Wagga Wagga Base Hospital, which has admitted negligence in the drug trial conducted from 2000 to 2003. Up to 12 other women are considering legal action against the hospital, which faces millions of dollars in compensation claims.
There is no evidence that misoprostol causes birth defects, but in August 2000 the manufacturer, Searle, since acquired by Pfizer, warned that it should not be used to induce labour at full term for this reason. It also warned it should not be used in pregnant women because it could cause abortion and birth defects such as club foot, missing fingers and brain injury.
Misoprostol is more likely to result in an excessive uterine response if given in high doses than the induction drugs prostin E2 gel or syntocinon and thus may pose more risks to mother and child.
In Victoria, misoprostol is only used for abortions, not to induce labour. It is, however, used to induce still births.
A Greater Southern Area Health Service spokesman said the trial was approved by the Area Health Service human research ethics committee, which conforms to federal requirements.
Documents show the NSW Medical Board called an obstetrician "arrogant" for using the drug on the woman at Royal Women's in 1997 without seeking her permission or informing her of the risks. In 2000, it found him guilty of "unsatisfactory professional misconduct" and fined him $5500.
"I'm absolutely outraged," the mother said yesterday. She and her husband said they believed the drug was responsible for their son's death although there is no evidence as the cause remains unknown.
Their son was born with no brain activity and died after two days on life support.
The parents' names are suppressed. "I just feel overwhelmed with grief . . . they tried to sweep everything under the carpet as if nothing wrong had been done," the mother said. "It was a premeditated act of playing God and it has ruined our lives."
Yesterday, a spokesman for Pfizer said it "recommends that the drug be used for the purpose for which it's registered".
The current warnings are: "Cytotec must not be used by pregnant women as it may cause miscarriage and this could lead to potentially dangerous bleeding." It is registered to treat gastrointestinal ulcers.