A leading figure in the battle to increase awareness about treating pregnant women, Dr. Gideon Koren believes urgent changes are needed in the field. He is the founder of Motherisk, an organization providing information and counseling on pregnancy and medication, staff pediatrician at The Hospital for Sick Children in Toronto, and professor at the University of Toronto. The Pregnancy & Medicine Initiative caught up with Dr. Koren to hear his strong views on pregnancy and medication.
How big a problem is the lack of information around pregnancy and medication?
It’s a huge issue. We see with Motherisk and similar services that women often have no genuine information about the safety of their medication on the one hand and the safety of not treating their condition on the other hand.
The same is true with many practitioners. We find a huge void in what they should know and often physicians are afraid to treat pregnant women. They go under the assumption that every drug is another thalidomide. The idea that everything can be dangerous is strengthened by the medical-legal atmosphere. This is mainly in North America, but also elsewhere.
What lies behind this data vacuum?
It’s a fast evolving area and unless a physician takes the time to find what is known today about the safety of a particular medication, he or she has a tendency to fall back on not taking any chances.
Very rarely do you hear discussions about the risk of leaving a condition untreated, but now that women tend to start a family at a later age, statistically many more will have a condition requiring medication. Unless they’re cared for by people who know the risk of those untreated conditions, it’s common to see decisions made without proper information.
What is happening around the collection of data on pregnancy and medication?
At present, drug companies don’t need to do anything beyond printing “don’t use our product” on their label. As a result, very few drugs have been tested for safety in pregnant women.
When industry studies are carried out in women of reproductive age, the woman must prove she is using contraception and, if she manages to conceive during participation, she will be excluded from the study. If you look at the percentages, you can see that very often women in these studies end up terminating the pregnancy. We don’t know this directly, but it’s clear that someone is scaring them.
What could be done to improve this situation?
When everyone realized that most medications for children had not been tested or proven for children, the American government and FDA enacted several laws that meant, if drug companies studied children, they would be given an extension of their patent. If the drug is a blockbuster, that could mean billions of dollars.
Here is an example where the legislator can make it worthwhile for drug companies to be involved. We must find a way to incentivize companies to include pregnant women in a similar way.
We’re hearing statements about the rights of women from the EMEA in Europe and the FDA in North America, but unfortunately, there isn’t much of a movement to see that more data is coming out, not just about what is safe but what is effective in pregnancies.
What would you like to see change around pregnancy and medication?
We must create a strong coalition – something that the Pregnancy & Medicine Initiative should be able to achieve – and get everyone working together to ensure that information is getting out and that women are treated.
The most acute and urgent matter is to somehow to create a new balance so that people are not just talking about the apparent or potential risk of a medication but also the risk of not treating a woman.
In 2014, less than 50 medications have been shown to cause malformations and even then with a minority of patients, not a majority. Thousands of drugs were safe. And yet women are shy of using them and physicians of prescribing them. That climate must change.
This will happen through education first and foremost. Education for medical and pharmacy personnel must start in medical school.
And what have been the main developments in the last few years?
There’s a real increase in sources of information that publish data on the use of medication in pregnancy. This is good news. You see more systematic use and meta-analysis of this data coming from all over the world.
Visit Motherisk’s website to find out more information about Dr. Koren and what the organization is doing.