The news of the death of eleven babies in the Netherlands because of a clinical trial in which their mothers participated during pregnancy, has left us in shock. And it makes us wonder, to what extent is it acceptable to undergo the effects of a new drug during pregnancy?
In this case, it was about Sildenafil, the generic Viagra (best known trade name). The trial was designed to see the possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.
The news has been released yesterday Tuesday, July 23, after verifying that of the 93 women who took the medicine, 17 babies were born with lung problems and eleven died from lung problems linked to the drug.
Vasodilator power
The researchers of the Academic Medical Center of the University of Amsterdam (AMC) were in charge of directing this study, which was carried out in 10 other hospitals in the country. They thought that the vasodilatory properties of Viagra (used to improve male erection), could help create a better blood flow to the placenta, and thus "stimulate the growth of fetuses" with developmental problems. Nothing could be further from the truth.
The research began in 2015 and should continue until 2020, with the study of 350 patients. So far, 183 pregnant women have participated. Of these, 93 took Viagra, and 90 a placebo. In the first group 11 babies died from an unexpected lung complication. Six other babies, who managed to survive, were born with lung conditions that prevented them from breathing normally.
In the second group, three babies were born with a pulmonary deficit, but survived. Nine others died due to stunted growth.
In view of these results It is thought that sildenafil also increases blood pressure in the lungs by reducing oxygen. According to those responsible for the trial “the tests performed by the hospital show that it can be harmful to the baby after birth. It increases the possibility of a disease of the pulmonary blood vessels, and also that of a subsequent death. ”
Stop testing in more countries
The substance that was tested has no negative effects on the mothers, although the 15 future mothers who have not yet given birth have already been warned of what happened.
In addition, gynecologist Wessel Ganzevoort, head of research, has warned his Canadian colleagues, immersed in a similar test: “We wanted to show that it was a good way to promote fetal growth. The opposite has happened. ”
What to consider in a clinical trial
Studies of new treatments or medications have a trial phase in patients. These tests are known as clinical trials, which are performed to determine the usefulness of the new treatment, if the effectiveness is greater than other treatments already available, the side effects of the new drug and if they are greater or less than the conventional treatment, if it exceeds benefits to side effects, in which patients the new treatment is more useful, etc.
Patients who participate must previously know the objectives of the study, its risks and benefits and sign the informed consent in which it is guaranteed that the person has voluntarily expressed their intention to participate in the investigation, after having understood the information that has been given, about the objectives of the study, the benefits, the inconvenience, the possible risks and the alternatives, their rights and responsibilities etc.
In addition, clinical trials must go through an ethics committee. This committee will verify the scientific and medical interest of the study, the risk / benefit ratio, the compliance with good methodological practices, especially those that concern the promoter and the principal investigator of the study.
Since the last royal decree entered into force, as of May 2016, all clinical trial evaluation procedures are common to all member countries of the European Union.
Via Europa Press
In Babies and More Tests in pregnancy: the measurement of the nuchal fold, Do not put your baby at risk: medicines prohibited during pregnancy
