Misinformation on emergency contraception

Emergency Contraception (EC) is part of the World Health Organisation’s list of essential medicines for reproductive health and is available without prescription in Malta as in the rest of the EU. Two medicines are available in Malta: Levonorgestrel (Escapelle) and Ulipristal acetate (EllaOne).

However, a few, mostly non-medical health care practitioners in Malta, continue to spread misinformation regarding the mode of action of EC.

As a medical doctor, a gynaecologist and a scientist, I strongly object to this. I further contend that failing to provide accurate information regarding EC as well as persisting in trying to have it banned may well be in breach of EU legislation.

Quoting Dr. Miriam Sciberras from Life Network Malta (MaltaToday, 6 February 2022): “The mechanism of action of the morning after pills is mostly anti-implantation, that is, they do not prevent ovulation and therefore possible fertilisation in most cases, but interfere with the implantation of the embryo in the endometrium.”

Absolute hogwash!

Contrary to the misinformation propounded by my esteemed colleague, a review of 33 scientific studies published in January 2022 clearly shows that, when taken after ovulation, Levonorgestrel EC does not affect implantation, and results in similar conception rates compared to placebo.

I strongly urge my colleagues at Life Network to immerse themselves in the detailed information regarding endometrial receptivity and blastocyst attachment before and after the LH surge provided here (https://bit.ly/34ttmlH).

This should put paid to their conspiracy theories that Levonorgestrel EC affects pregnancy implantation. Women and girls who need to take EC should also be reassured by the fact that if pregnancy does follow, there is no evidence that it affects fetal development, miscarriage, or stillbirth.

Based on extensive literature published in respected peer reviewed mainstream journals, the European Public Assessment Report (19/12/22)  published by the European Medicines Authority states unequivocally that EllaOne works by stopping or delaying ovulation, and hence preventing fertilisation (https://bit.ly/3rFQcPM). The best available evidence is that EllaOne does not prevent implantation, and if ovulation has already occurred, it is no longer effective. At a dose of 30mg, it is highly effective and well-tolerated and has been marketed for use as a safe method of EC in Europe since 2009.

The icing on Life Network’s misinformation cake is the allegation that because EllaOne and Emysa contain the same active ingredient, and the FDA has refused to approve Esmya because of liver injuries, then women should be worried about similar issues when taking EllaOne.

Yes, both EllaOne and Esmya contain ulipristal acetate but the similarities between them begin and end with the chemical compound they share, as they are very different when it comes to how they are used. A single 30mg EllaOne pill taken within five days of having unprotected sex is effective at stopping ovulation. Although it can be taken on multiple occasions in the case of multiple slip-ups, it is not designed for continuous use.

Esmya, on the other hand, is a medication intended to shrink uterine fibroids which are growths in the muscle tissue of the uterus that often cause heavy bleeding. It was approved at a 5mg dosage by the European Medicines Authority and is intended for continuous use. That means that, while one EllaOne pill is a higher dose than one Esmya pill, Esmya’s cumulative dose is much higher.

This is true whether Esmya is taken for a few months before surgery, as it was initially approved, or taken long-term. Because of this, patients taking Esmya have a very different risk of complications than those taking EllaOne. Data collected by the European Medicines Authority supports EllaOne’s safety and efficacy as an emergency contraceptive. Also, there is no difference in the number or seriousness of side effects in overdoses of up to 200 mg (i.e., six times higher than one EllaOne tablet). Claims that EllaOne is dangerous are extremely exaggerated.

It seems my esteemed colleague and I can only agree on one point: scientifically correct information should be made available to doctors, pharmacists, consumers and politicians.

May I therefore suggest that she forwards any evidence that EC interferes with fertilisation and implantation, or that it causes serious liver damage to the European Medicines Authority. Let us see if they change their position. I very much doubt it.

When Life Network publicly posts (mis)information about EC, they are in effect advertising the product. Under EU legislation, providing information about medication falls under the advertising directive and is not what one would call advertising in general terms. One of the key issues is that advertisements of medicines must be factual, meaning in accordance with the Summary of Product Characteristics.

So for example, one cannot advertise a product that is intended to treat acne while showing a picture of a person with perfect skin, because that is not what is likely to actually happen.

Given that Life Network persists in publishing factually incorrect information about EC, perhaps the Medicines Authority would care to issue a statement regarding the mode of action of EC, as well as to look into this possible breach of EU legislation.

Moreover, in the context of a total ban on abortion in Malta, the fact that these safe medicines cost between €18-35 a pop, makes no sense at all. By comparison levonorgestrel costs just under €12 in the UK (£10)! Neither do I understand why the pharmacists in Malta who persist in quoting conscientious objection as justification for not dispensing either of these safe medicines do not put up a sign outside their premises declaring this, while also indicating the nearest pharmacy that does.

For the record, I will state that I am not personally “anti-birth, anti-life and anti-faith” as alleged. Indeed, I am the proud mother of three and now a nanna!

But I will defend till my dying breath every person’s right to choose whether and when to give birth as well as which faith they choose to follow. I only wish Life Network would do the same.