A woman who took part in a Dutch drug trial in which 11 babies died has spoken of going through a “whirlwind” of emotions before she signed up.
Lana Huf-Germain (38) was one of 183 pregnant women who took part in a programme to test whether the drug sildenafil, which is sold under the brand name Viagra, would spur the growth of unborn children in the womb.
The women were informed on Sunday that the trial, which started in 2015, was being terminated due to the high number of deaths among babies born to mothers who took the drug.
Huf-Germain, whose daughter was born prematurely two years ago but is now healthy, said she had been told she was on a placebo in the trial.
Between 10 and 15 women were still taking part up in the trial until last Thursday and now face a terrifying wait to learn whether their unborn children have been affected.
Huf-Germain said she did not recall being told of any risks to her child at the start of the trial, but such was the desperation of the women involved that few would have comprehended the possible consequences.
She told the Guardian: "At the 20-week scan they said my daughter was way too small and we needed to go to hospital. One of the first things we heard was that they were doing this research and they said it might benefit us.
“A doctor came in and told us what Viagra basically does and it still seems very plausible. So we said ‘yes, sure, let’s go’. I’ve asked my husband: ‘Did they tell us the risks?’
“We were in a whirlwind. I can’t even remember what I signed. She might have said something. But it wasn’t that clear that we said: ‘Let’s think about this.’ We were: ‘Let’s screw it and do it.’ ”
Huf-Germain added: “In fairness they did not know, as far as I know, about the risks. That’s why I can’t blame them. It’s easy for me to say because my daughter is alive and I am fine. If it had worked out great they would be heroes.
“My husband needs therapy after this. He’s saying: ‘We will do no tests ever again.’ People are going nuts about it. I am more on the doctors’ side. It is horrible for the parents who are still pregnant now and have been taking it. That’s a whole different ball game.”
The research was carried out at 10 hospitals across the Netherlands and involved women whose placentas had been underperforming.
Sildenafil, which dilates the blood vessels, is commonly used for erectile dysfunction in men and is prescribed for people with high blood pressure. It is sold by Pfizer as Viagra, but the pills used in the study were not produced by the pharmaceutical giant.
The researchers informed the women that common side-effects were dizziness, rosy cheeks, headaches and an increased sexual appetite.
Proceeding research
The hope, backed up by experimental research on rats, had been that the drug would encourage a better flow of blood through the placenta, promoting the growth of the child.
The women taking part all had unborn babies whose growth had been severely limited in the womb. The children’s prognosis, given a lack of available therapy, was regarded as poor as a result.
In total, 93 women were given the drug as part of the trial, led by Amsterdam University Medical Centre (UMC). Seventeen babies developed lung problems, and 11 died. A further eight babies in the trial died of unrelated conditions.
Of the 90 women in a control group who took a placebo, three had children who developed the same lung issues, but no babies died from conditions that could be linked to sildenafil. Nine babies died from unrelated problems.
A spokesman for Amsterdam UMC said the women waiting to find out if their child was affected had been offered counselling, as had those whose children had died.
It is thought that the drug may have caused high blood pressure in the lungs, leading to the babies receiving too little oxygen. There is nothing to suggest the trial was mishandled, and a spokesman said the full range of risks was listed in a consent form.
Huf-Germain said: “I think in hindsight you make the decision, it feels like you flicked the switch – dead or alive. That’s why people are in a rage. You feel responsible for killing your child.”
A trial in the UK, from which results were published last December, offered no convincing evidence either way about the drug’s efficacy or any risk to patients. The Dutch researchers have advised women in the UK trial to heed the results of their study. – Guardian