The EU-funded Innovative Medicines Initiative, CONCEPTION, aims to improve monitoring and communication of medication safety in pregnancy and breastfeeding. Here we speak to two of the project’s leaders about their respective roles in the project and what they believe will be its long-lasting impact.
Dr Ida Niklson is a psychiatrist by training. She spent 17 years in academia teaching followed by 25 years in the pharmaceutical industry in several companies developing medicines, most recently Novartis. In the last years, she has been retained by Novartis as a consultant, and leads the CONCEPTION project for Novartis, together with Prof. Dr. Sturkenboom,
Professor Miriam Sturkenboom is an expert in pharmacoepidemiology who works at UMC Utrecht. Originally trained as a pharmacist, she also has a masters degree in epidemiology from Harvard University. Her work focuses on building knowledge from automated health care data in the area of disease epidemiology, drug safety and prevention and leads the project together with Dr. Niklson.
Many expectant mothers who have battled morning sickness know just how debilitating and distressing it can be. That’s why when a new sedative drug came to the market in the 1960s and was soon discovered that it alleviates nausea and vomiting during pregnancy, thousands of women worldwide gratefully accepted it from their doctor. It was also marketed as a mild sleeping pill that was perfectly safe for pregnant women.
We now know that thalidomide wasn’t safe – thousands and thousands of babies were born with missing or malformed limbs. The drug had not been studied properly in animal studies and appeared to have a devastating impact on unborn infants.
Indeed, pregnant women have long been excluded from medical research, for reasons which may seem obvious. “Pregnancy and breastfeeding have long been a neglected area of research,” says Dr Ida Niklson. “But the thalidomide tragedy came around because of lack of research, not due to research.
This means there is a massive information gap when it comes to the safety of medications taken during this time, despite most pregnant women saying they have taken at least one medicine, says Professor Miriam Sturkenboom.
“At the same time, we see that more and more women need to be treated, because the age of pregnancy is later and this means the incidence of co-morbidities is increasing quite rapidly,” she explains. Data shows that between 57 and 95 per cent of women have used one or more drugs during pregnancy, she adds.
This means women and doctors must decide themselves what the risk/benefit is when it comes to taking medication during pregnancy. And despite there being little information on drugs used during pregnancy and their impact, there is virtually none when it comes to women who are breastfeeding – 98% of drugs contain no information about their compatibility with breastfeeding.
How can this knowledge gap be addressed? “There is still a perception in the industry of pregnant women being a special population in which you cannot do research,” says Dr Niklson. She wants to see the pharma industry, regulatory bodies and medication labels move away from concentrating only on risk to that of risk and benefit. It is important to find that balance so that pregnant women are properly informed and can decide to receive the appropriate treatment or not.
This is where ConcePTION comes in. This five-year project aims to tackle the fragmented landscape around medication in pregnancy and breastfeeding. The project will focus specifically on developing methods to generate information on medication use during pregnancy and breastfeeding using different sources of information. Another important element is informing women, healthcare professionals such as doctors and midwives, and other stakeholders about the use of medication during pregnancy and breastfeeding. In order to study medications in breast milk, the project aims to build a model that will allow to predict the concentration of medicines in breastmilk and create the first Europe-wide breast milk biobank.
Dr Niklson explains that the ConcePTION researchers will be using all the available data to paint a picture of how medications impact pregnancy outcomes on unborn babies, as well as the transfer of medications into breast milk. This information can then be conveyed to doctors wishing to prescribe certain medications, as well as the women who will take them.
“Informing the public is possibly the most critical element, so we want to put all this information in an accessible way for both healthcare providers and patients,” she says.