Issue link: https://maltatoday.uberflip.com/i/1450614
EMERGENCY Contraception (EC) is part of the World Health Organisation's list of essen- tial medicines for reproductive health and is available without prescription in Malta as in the rest of the EU. Two medicines are available in Malta: Levonorg- estrel (Escapelle) and Ulipristal acetate (EllaOne). However, a few, mostly non-medical health care prac- titioners in Malta, continue to spread misinformation regard- ing the mode of action of EC. As a medical doctor, a gynae- cologist 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 Sciber- ras from Life Network Malta (MaltaToday, 6 February 2022): "The mechanism of action of the morning after pills is mostly an- ti-implantation, that is, they do not prevent ovulation and there- fore possible fertilisation in most cases, but interfere with the im- plantation of the embryo in the endometrium." Absolute hogwash! Contrary to the misinforma- tion propounded by my es- teemed colleague, a review of 33 scientific studies published in January 2022 clearly shows that, when taken after ovulation, Lev- onorgestrel EC does not affect implantation, and results in sim- ilar conception rates compared to placebo. I strongly urge my colleagues at Life Network to immerse themselves in the detailed in- formation regarding endome- trial 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 Levo- norgestrel EC affects pregnancy implantation. Women and girls who need to take EC should al- so be reassured by the fact that if pregnancy does follow, there is no evidence that it affects fe- tal development, miscarriage, or stillbirth. Based on extensive literature published in respected peer re- viewed mainstream journals, the European Public Assessment Re- port (19/12/22) published by the European Medicines Authority states unequivocally that El- laOne works by stopping or de- laying ovulation, and hence pre- venting fertilisation (https://bit. ly/3rFQcPM). The best available evidence is that EllaOne does not prevent implantation, and if ovu- lation has already occurred, it is no longer effective. At a dose of 30mg, it is highly effective and well-tolerated and has been mar- keted for use as a safe method of EC in Europe since 2009. The icing on Life Network's misinformation cake is the alle- gation that because EllaOne and Emysa contain the same active ingredient, and the FDA has re- fused 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 be- gin 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 ovu- lation. Although it can be taken on multiple occasions in the case of multiple slip-ups, it is not de- signed 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 in- tended 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 ap- proved, or taken long-term. Be- cause of this, patients taking Es- mya 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 contra- ceptive. Also, there is no differ- ence in the number or serious- ness of side effects in overdoses of up to 200 mg (i.e., six times higher than one EllaOne tablet). Claims that EllaOne is danger- ous are extremely exaggerated. It seems my esteemed col- league and I can only agree on one point: scientifically correct information should be made available to doctors, pharma- cists, consumers and politicians. May I therefore suggest that she forwards any evidence that EC interferes with fertilisation and implantation, or that it caus- es 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 advertis- ing the product. Under EU leg- islation, providing information about medication falls under the advertising directive and is not what one would call advertis- ing in general terms. One of the key issues is that advertisements of medicines must be factual, meaning in accordance with the Summary of Product Character- istics. So for example, one cannot ad- vertise a product that is intend- ed 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 per- sists in publishing factually in- correct 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 Mal- ta, the fact that these safe med- icines 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. 13 maltatoday | SUNDAY • 13 FEBRUARY 2022 Prof. Isabel Stabile is a gynaecologist and a member of Doctors For Choice OPINION Isabel Stabile Misinformation on emergency contraception