This is tragic:
The death of 11 babies born to women who were given sildenafil during a drug trial has led to the termination of the experiment – and an anxious wait for other mothers involved. Sildenafil is sold by Pfizer as Viagra, but the pills used in the study were not ones produced by the pharmaceutical giant.
The trial was designed to test whether the medication could help boost babies’ growth in the womb.
The research was carried out at 10 hospitals across the Netherlands and involved women whose placentas had been underperforming.
Viagra, which dilates the blood vessels, is used for erectile dysfunction in menand is prescribed for people with high blood pressure. 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 in the trial 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.
The trial was terminated last week when an independent committee overseeing the research discovered that more babies than expected were being born with lung problems.
The problem with any new medicine or treatment is, no matter how much research you do on rats, monkeys, and in simulations eventually you have to try it out on humans. Until then, you’re never sure what the results will be and sometimes, as in this case, they’re not good.
Back in 2006 a human drugs trial went catastrophically wrong and turned into a full-scale medical emergency, leaving the victims disfigured for life:
On a hospital ward, patients were writhing and screaming in agony. Their organs were failing, their heads swollen and many were projectile vomiting as their immune systems began to completely shut down. It looked like a scene from a horror film, yet this was the appalling reality for six young men who had been in perfect health until they signed up to take part in a drugs trial a decade ago.
It was, they believed, a chance to make some easy money and do their bit for medical science at the same time.
But what should have been a routine trial in a private clinic at Northwick Park Hospital, North-West London, soon spiralled into one of the most infamous medical emergencies, and became known as the ‘Elephant Man’ drug trial because of its shocking side-effects. Now a BBC documentary is to revisit the dramatic events that resulted in the young men fighting for their lives.
Human drugs trials take place every day, and horror stories like the ones above are rare indeed. But until someone can come up with a robot which can exactly mimic the human body’s reaction to any drug, they’ll remain the price to pay for modern medicines.