Drug Trial Using Viagra On Pregnant Women Ends In Tragedy

Medical trials, particularly those involving humans, must be carefully thought out, precisely implemented, and surrounded by safeguards. The vast majority of them proceed without incident, leading to evidence for or against a hypothesis. Some, sadly, can go wrong – sometimes with deadly consequences.

As reported by BBC News, a Dutch study is proving to be one such grim example: It’s been stopped after it led to the deaths of 11 newborn babies. It appears that the women taking part were given sildenafil, the non-brand name for Viagra. Although famous for its specific uses, in general terms, it stimulates blood flow.

The unborn babies had placentas that hadn’t developed properly. The organ, which is attached to the lining of the womb during pregnancy, both segregates the woman’s blood supply from the developing baby’s, while also connecting them in order to allow oxygen and nutrients to reach them via the umbilical cord.

This trial hoped that the Viagra would boost the blood supply to the poorly developed placentas – otherwise, the babies had a bad prognosis. Involving 11 researcher institutions or hospitals in the Netherlands, 93 women were given the drug, while a similar number were given a placebo – standard practice in such trials.

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An earlier series of trials elsewhere in the world previously found no benefit nor harm to the use of the drug in this way, but this trial has led to multiple deaths. It’s been suggested that the drug caused fatal damage to the baby’s lungs by elevating their blood pressure and stifling their supply of oxygen.

In total, 17 babies whose mothers were given the drug developed lung problems after they were born, and 11 have died since, with eight others dying of unrelated conditions, per The Guardian.

In the placebo group, three babies developed a similarly dangerous lung condition, but none of them died of anything related to the drug. The study was due to be carried out until 2020, but after the unusually high number of deaths were spotted by an overseeing committee, the trial was terminated. So what went wrong?

At this point, it’s hard to say, but there’s no evidence suggesting that the trial was conducted in a poor fashion. At the same time, it’s worth emphasizing that Viagra itself hasn’t suddenly become dangerous in its normal use.

Naturally, those running the research are deeply shocked and saddened. Professor Stephen Evans, a pharmacoepidemiologist at the London School of Hygiene & Tropical Medicine who wasn’t involved in the research, told the Science Media Centre that such trials, although rare, are undertaken with considerable thoughtfulness.

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“Great care is taken with trials involving pregnant women, and drug companies are reluctant to do them, which is why our knowledge of medicines in pregnant women is so limited,” he explained. “Such trials are often carried out by academic groups rather than drug companies,” as was the case this time around.

However, he noted that the trials are done because the outcome is unknown, and that independent committees carefully assess the data used to justify each trial before it’s allowed to go ahead.

“There have been other studies in this area, both involving preliminary work using animals and using pregnant women, and there was no indication that the treatment was dangerous based on previous research,” he added.

It’s safe to say that no one foresaw this awful outcome. An investigation is likely already underway to determine the precise cause of death, and why it occurred this time and not in previous trials.

Original Article : HERE ; This post was curated & posted using : RealSpecific

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