Læge Amani Meaidi om Safe Choice: "Det er et spørgsmål om patientsikke

In 2020, 416,810 Danish women received a prescription for hormonal contraception*, and with 268,390 prescriptions for the contraceptive pill, it was by far the most popular solution to prevent pregnancy. But hormonal contraception comes with both its advantages and disadvantages - and it is especially the latter that should be thoroughly investigated.

Since the contraceptive pill or just The Pill's release in 1966, the little round pill has revolutionized the lives of millions of women. Despite its modest size, it fundamentally changed the lives of half the world's population (those who had access to it). It made it possible to regulate family planning, it gave a completely new access to the labor market, to education - it liberated women - and their sexuality.
And for many grandmothers, the little pill will forever stand as one of the most special things that happened in their lives. The right over one's own body to which it gave access to a greater degree than ever before.

But over the past decade, new trends and opportunities have emerged. A new generation of women is making demands on the contents of their menstrual products - some of us are putting the tampons back on the shelf and reaching for the silicone cup or menstrual panties instead. And when we have to protect ourselves against unwanted pregnancies, we are ready to challenge the common choices to a greater extent, some opt for a medtech solution, which can indicate the fertile window, while others are going back to nature and educating themselves on their own body signals such as temperature measurements and examination of our secretions to map our own cycle.

Lack of mapping of side effects

Since 2012, in Denmark the number of prescriptions for birth control pills has fallen from 388,258 to 268,390. A significant drop which speaks to the overall trend we see. Young women taking back their health to a greater extent, with fewer accepting the side effects written in fine print on the package insert when you open a new pack of hormonal contraception. Risk of depression, migraines, weight gain, certain cancers, even side effects such as suicidal thoughts.
In reality, we only know a small sample of the side effects of hormonal contraception. Because there has never been a national, broadly represented survey of them. According to doctor, researcher and postdoc Amani Meaidi, there has probably never been any interest in it. Despite the fact that the vast majority of women of reproductive age will use a hormonal contraceptive at some point in their lives. But that is changing now.
Amani has started Safe Choice together with two female colleagues. A national study which aims to detect, investigate and describe side effects when using hormonal contraception. And the research team's biggest challenge, for once, has not been to obtain funding (thanks to a large donation from Sygesikring Danmark of DKK 6.5 million) - although that would normally be the most widespread stop for research into women-related diseases and issues ( only 1-3% of the global funding given to research is given to areas specifically related to women's diseases). The biggest challenge is more practical: getting answers back to the surveys that are sent out.

A question of patient safety

And that is important. Because the study is ambitious. It is the largest study of hormonal contraceptive side effects to date. One million Danish women aged 15-45 have been or will be invited to the survey via email. But right now only 10-15% are responding back. And to validate the results, a minimum of 50% must respond back. And this applies to women who have used or are using hormonal contraception - but also to those who do not or never have. And that is regardless of whether you experience side effects or not. It is important to have a broad representation in order to obtain the optimal comparison group in the study.
"We know some of the major, serious side effects of hormonal contraception, which are registered when they occur. But we also have patients who experience mood swings, weight gain, anxiety - and these may never be registered, for example because the women do not link them to their contraception. Or they are considered too small to be taken seriously".
With her rapid flow of speech, Amani Meaidi seems incredibly passionate about women's health, and when we ask what motivates her, the answer falls quickly: “I don't see this as a feminist project or myself as a feminist. I am a doctor, and I must say that the research in this area is completely lacking. So this is really a patient safety issue. It does not agree with my moral compass and my professionalism that I advise female patients within my field of expertise, gynecology - without having the evidence completely in place. And I don't have that, we as doctors don't have that. Our research is lacking when it comes to the impact of contraception”.

It's hard not to wonder why the data isn't already there when it's been almost 60 years since the birth control pill was released, why is it taking so long?
“That's a really good question”, says Amani, “It's so complex. Women have been neglected in medical research for centuries. Medicine is tested on men, we have used male mice and not female mice in the laboratories. The whole of medical science is based on the 'reference man', and that is given a large male bias. It is expressed culturally, historically, medically and politically. Women have been and still are under-prioritised in the world of medicine. But we are seeing a generational change both among doctors and patients. We see women who are blessed with rights their grandmothers fought for, but who are also ready to make new and reasonable demands. Where before we were willing to accept serious side effects such as blood clots and increased suicide rates, because the freedom we gained over our own bodies was so precious, younger women are speaking out, despite decades where doctors, sex education teachers, parents have agreed , that these are acceptable side effects”.

Research on a voluntary basis

Today, there are three types of hormonal IUDs, all of which release different concentrations of the hormone progesterone, which prevents pregnancy. And in her latest publication, Amani Meaidi has shown that the hormonal IUD, with the lowest dose of hormone, actually increases the risk of ectopic pregnancy more than the other hormonal IUDs on the market. Ectopic pregnancies which in the worst case can be life-threatening. "And this exact IUD is typically the one we give to younger, fertile women", notes Amani. Research by the wat, which she has done in her spare time, without funding. This is actually the case with 80% of Amani's research, she estimates. It is made on a voluntary basis, without funding. Also the one she has done in medical abortions, which has meant that 60% fewer women now experience complications from medical abortion. It required something as simple as rolling out an e-course for gynecologists. The passion for gynecology that Amani possesses is crystal clear to anyone a few minutes into a conversation with her.

Maybe we need fewer contraceptive options?

There are high expectations for what Safe Choice can contribute to. One is to map out new side effects. "There will almost always be new knowledge about a medicine's side effect profile after it is rolled out to the general population rather than in the laboratories or in the small clinical studies that are carried out before the medicine goes on the market. We saw this, for example, specific types of the corona vaccine, which suddenly turned out to cause blood clots when it was put to use by millions of people. Finding new side effects is to be expected. And that is also why it is important that we get as many responses back as possible. Because regardless of medicine, we must always map out the advantages and disadvantages of it, and it should ideally be the case that there are more advantages than disadvantages before we prescribe".

In the long term, the goal is to be able to develop a digital tool that can show a user which form of contraception is the gentlest for her. Here you will be able to enter various information with your health information and thereby also choose the right form of contraception with the fewest possible risks. A way to merge personalized medicine into the world of contraception, which in the past has been prescribed very broadly without looking too much at the recipient.
"I want to create as much evidence in this area as possible - and frankly: Start a debate among colleagues, perhaps shake up the perspective that the advantages of all contraceptives outweigh the disadvantages. Can I show that the smallest hormonal IUD has a very unfavorable effect without having a great advantage over other hormonal IUDs? Because then we might have to change what contraception is available. And we should definitely have the same high demands for hormonal contraception as in other medicines".

What can you do yourself?

• Participate in the survey (only for Danish citizens) if you've been invited through Eboks. It takes approx. 20 minutes - and please answer regardless of whether you have experienced side effects or not, whether you've tried hormonal contraception or not.

• When you have an appointment with the doctor to discuss birth control, mention all the problems you are having, nothing is too small: Do you have a tendency to get cystitis? Headache? A history of blood clots in the family? Even if you yourself do not link its relevance to your choice of contraception.

• Ask for information. You should know that the hormones in contraception affect all the body's organs. And you must be able to make the right decision for you based on that information.

Read more about Safe Choice here .
*Hormonal contraception here covers birth control pills, mini pills, hormonal coils, birth control sticks, birth control injections, birth control rings and birth control patches. The figures come from Sex and Society