That sildenafil could be dangerous nowhere

After the unexpected death of many babies, the University Hospital Amsterdam UMC immediately stopped a study last Thursday with pregnant women whose fetuses and placenta were too small. The study tested whether sildenafil, better known as viagra, could cure stunted babies.

Of the 93 women who took the drug, 19 babies died of delivery, 11 of them had a possible lung condition. In the 90 women who took a false pill (placebo), 9 babies died, but not a lung disease. These figures were so disturbing that it was decided to stop.

1 Were there any signs that this investigation could be dangerous?

The study targeted pregnant women with an unborn child who was not growing well because of a placenta that was too small and poorly perfused. Such a child is in danger of death. One option is to have the child early in the world, but for a child (a lot) premature the danger has not gone away. The alternative is to lengthen the pregnancy as long as possible and eventually include the future mother in the hospital. This too is not safe for the child.

There is no drug that prolongs pregnancy or helps the fetus to develop better. We are looking for that. A modern approach, especially in these rare diseases, is to examine existing drugs or to have a mechanism of action that might help. For example, researchers used sildenafil years ago, better known as the erection-promoting drug, viagra. Sildenafil dilates the blood vessels. This could help improve the blood flow of the small placenta, giving the slow-growing fetus more nutrients.

In previous research in women who had such a dangerous pregnancy, in which, however, no group took false tablets, sildenafil or sildenafil was good for the child. Doctors in Taiwan and India have reported in medical journals that they are already using sildenafil in pregnancies with a low-growing fetus and a small placenta.

It was decided to set up five well-conducted separate studies in five countries. They are funded with government money. The pharmaceutical industry is not involved. All studies have been approved by local committees of medical ethics. Four of the five studies really started. Several studies have been set up because, in the medical world, a study is not a study. He offered the opportunity, after completion, to show a convincing result in a meta-analysis, favorable or unfavorable for sildenafil. All plans and study plans are described in a scientific article.

2 Have these other studies been stopped?

After an alarm report from the Netherlands, Canadian researchers decided to suspend their searches last Thursday, said Amsterdam spokesman UMC. Investigations in Australia / New Zealand and the United Kingdom were completed. The British published their results in December

With the British study, 135 pregnant women participated – in the Netherlands, 354 pregnant women had to participate. Always in British pregnant women, fate indicated whether they were taking sildanifil or fake pills, just as in the Netherlands. The difference could not be seen from the pills. Their referring doctors did not know who took which pill. This is what is called randomized double-blind research. This is the best research that can be done to find an effect that is influenced by the least possible disruptive factors.

The British study did not have a disturbing result. The conclusion was that there is no statistical difference between the duration of pregnancy and the babies of women who received sildenafil and took a false pill. Women who took sildenafil were 8% more likely to have a baby who was dead or had a serious illness. This is not directly disturbing, as the limits of uncertainty range from -9 to 28%: there was a chance that sildenafil would be even safer. Published comments show that the researchers were disappointed. Sildanafil did not seem to work here. It has been suggested that the given dose (75 milligrams of sildenafil daily) may be too low.

3 Have these dead babies been prevented? Did parents explicitly point out this risk?

If you look at the scientific literature on drugs to help a little fetus and a placenta that works poorly, then it's clear that no cowboy was working in Amsterdam.

Animal testing was done but nothing to worry about. The same thing applies to randomized studies in pregnant women with a fetus too small. Even the UK randomized study on pregnant women, similar to the Dutch, has not resulted in an alarming result.

According to the information that all pregnant women received before signing the forms of participation in the study ] informed consent ), that NRC has received for inspection, shows that researchers were especially at risk from mothers. They were told that the product could lead to headaches, hot flashes, dizziness and a stuffy nose. Suspicions that sildenafil could lead to a fatal outcome in the child were not present. Regarding the risks for the child, the researchers wrote in the consent form: "Until now no harmful effects have been described yet."

4 What happens to pregnant women who also swallowed the substance? 19659002] In the Netherlands, another 30 pregnant women took sildenafil or placebo. They are here after Thursday afternoon – when the large number of deaths among researchers have been known – said Amsterdam spokesman UMC. How their pregnancy is developing is still waiting. The hospital assumes that about half of these women have taken viagrapil and are therefore still at risk.

11 hospitals across the country were involved in the study. All patients were informed by their doctor by phone. Children who are already born are closely monitored and victims are emotionally assisted if necessary.

5 How suddenly is such an inquiry stopped?

Exceptionally. A study is more often stopped because an interim analysis shows that the study drug works so much better than the false pill that it is considered irresponsible to expose patients to a placebo.

Stop after the patient's injury comes to the news when people are killed. In the Netherlands, the UMC Utrecht was seriously deceived in 2008 in a study on probiotics. Twenty-four patients who received the drug considered innocent died. In France, two years ago, one died in a research institute on drugs in Rennes. Two people sustained permanent brain damage

6 What can victims still do now?

It is not yet known whether the victims of the investigation file a complaint. If the parents of deceased babies want to start a procedure, a long and difficult legal battle awaits them.

The chances of success are minimal, says lawyer Frans Joosten, a specialist in personal injury and insurance law, because of the complexity of this type of medical practice: "The burden of proof lies with the patient He must prove that the doctor has made a mistake and that the damage has been caused.It must also be shown that all the information known to the doctor has not been passed on to the patient in time. lawyer, such a procedure takes five to six years. "It's almost impossible for parents: legal and emotional."

In the case of medical errors, the hospital or insurer customarily makes arrangements with the injured party about compensation. "It's usually between 5,000 and 10,000 euros," says Joosten. In this case, the parents of a deceased baby are entitled to a maximum of 20,000 euros and funeral costs, says Joosten. "But the chance that victims get this amount is low."

Many of his clients do not do it for money. "They want to prevent a doctor from coming out and the same mistake will happen again in the future." Despite this, Joosten warns of "legalizing" medical research: "If every medical examination can be expected to be a claim, no one starts an investigation." And suppose you are asked: Are there any a doctor in the room? Then all the doctors would dive under the table. "