Woman who took part in Viagra trial while pregnant shocked to learn 11 babies died
'As far as I know, they didn't tell us there were any risks to the baby,' says Lana Huf-Germain
When Amsterdam's Lana Huf-Germain got an unexpected call from a gynecologist on Sunday, she thought it was a prank.
Then the person on the other line said: "We don't want you to hear this from the media."
"Literally every flag went red in my head," Huf-Germain, 38, told As It Happens guest host Laura Lynch.
The doctor was calling to inform her that a drug trial she'd participated in while she was pregnant two years ago was being shut down after 11 babies died.
"It was shocking, of course," Huf-Germain said. "My husband was completely freaked out."
'A matter of life and death'
The Dutch trial of pregnant women was testing whether sildenafil — better known by the brand name Viagra — could help spur the growth of undeveloped unborn babies in the womb.
Huf-Germain was told she only received placebos during the trial. Her daughter Ruby, now two-years-old, was born prematurely, but is now healthy.
Huf-Germain said she remembers the day she decided to sign up for the trial.
She was 20 weeks pregnant and had just learned the fetus was severely underweight.
That's when doctors told her about a promising new study about the possible beneficial effects of sildenafil, which researchers believed would increase blood flow to the placenta.
"It was kind of a matter of life and death when it came to my unborn child," she said.
"As far as I know, they didn't tell us there were any risks to the baby. So at that point we were like, 'Yes, let's do this,' because we don't really have a choice at this point."
'I can't be mad at them'
The study started in 2015 and involved 11 hospitals. When the trial was stopped on Monday, roughly half of 183 pregnant women participating were taking sildenafil, the Amsterdam University's Academic Medical Centre (AMC) said.
"Previous studies have shown that sildenafil would have a positive effect on the growth of babies. The first results of the current study showed that there may be adverse effects for the baby after birth," the AMC said.
AMC said 17 babies were born with lung conditions and 11 died. Among the roughly equal control group, just three babies had lung problems and none died.
Around 15 women who took the medication have not yet given birth.
Despite the tragic results, Huf-Germain said she doesn't hold a grudge against the researchers.
"They also didn't know, as far as I know, that anything bad could happen to the child," she said.
"If it would have worked, they would have been heroes. We would have had something that changed medical history for fetuses that don't grow well.
"I can't be mad at them. But that's my logic. I mean, I haven't lost a child."
Same study took place in Canada
A similar Canadian study has been halted because of the Dutch findings, although the researchers say there have been no negative side effects reported in that study.
A professor at the University of British Columbia confirmed 21 Canadians have been taking part in the trial. They were recruited in 2017 under Health Canada approval, with funding from the Canadian Institutes of Health Research.
Huf-Germain said she's worried about the Canadian women.
"I think they need to have a psychologist on board to help them get through this," she said. "They're probably sweating bullets right now. I can't imagine what they have to go through."
Written by Sheena Goodyear with files from Canadian Press. Interview produced by Samantha Lui.