A reply to ‘Morning-after pill cannot interrupt established pregnancy’ – Medicines Authority chief

I feel obliged to reply to Prof Serracino Inglott,s who is also a pharmacist, whose intervention was published in Times of Malta (18 June 2016) where he maintained that the morning-after pill cannot interrupt established pregnancies. He maintained that it should be authorised in Malta. He says that there is no scientific reason why Emergency Contraceptives (EC’s) should not be sold in Malta. I tried to publish my reply on Times of Malta but I was unable to do so. Almost all his arguments are based on Summary of Product Characteristics (Specs) and product literature, which originate from the EC manufacturers themselves. I am not saying that these are not valid or wrong, but making reference to more detached and independent studies as well would help demonstrate more balance.

Indeed, I have already written on the subject in this newspaper and made reference to various categories of international scientific studies which showed the opposite, ie that emergency contraceptive pills are potentially abortive, mainly because they render the endometrium inadequate for a fertilised egg/embryo to implant in the uterus (see Docs below). I repeated my views and backed them with scientific evidence before the Parliamentary Committee. I then sent to all the Committee members an explanation of the papers I tabled as evidence. The main text of the email I sent to the clerk, which was sent to all the Committee members, was as follows:

....in order to clarify [to the Committee and the public] certain issues in regard to my speech and the accompanying documents I handed to the Chairman/Committee (as evidence to what I said).... following is a list of the documents I presented yesterday during the session, including clarifica- tions and comments:

Endometrial effects of single earlyluteal dose of the selective progesterone receptor modulator CDB-2914 (2010). Marked as Doc. 1. This clinical study shows that Ulipristal acetate (emergency contraceptive) has similar effects on the endometrium to mifepristone, the abortion drug.

How do levonorgestrel-only emergency contraceptive pills prevent pregnancy? Some considerations (2011). Marked as Doc. 2. This is a paper from researchers explaining that many studies “showing” that emergency contraceptives (levonorgestrelbased) do not interfere with embryo implantation have huge lacunae and shortfalls.

Letter to the editor of Journal Contraception (2013). Marked as Doc. 3. This commentary shows that studies “showing” that emergency contraceptives (Ulipristal acetate-based) do not interfere with embryo implantation have huge lacunae and shortfalls.

Effects of ulipristal acetate on human embryo attachment and endometrial cell gene expression in an in vitro co-culture system (2015). Marked as Doc. 4. This is a study which states that there is no negative effect on embryo implantation/attachment, but the authors admit that the study is limited because it is in vitro and not all cells that are present in a real (in vivo) uterus/endometrium were present in the biopsies/tissues studied.

Mechanism of action of ulipristal acetate for emergency contraception: A systematic review (2016). Marked as Doc. Extra 1. In its conclusion, this review says “...no effect on endometrium has been shown at clinically relevant doses”. I did not make direct reference to this paper in my write-up/speech. One should note that this review makes reference to in vitro studies (for instance Doc. 4) which, as I explained, were criticised by other researchers, such as in Docs 2 and 3 above.

https://www.princeton.edu/~p rolife/articles/embryoquotes2.ht ml (Marked as Doc. Extra 2). Website from Princeton.edu showing life starts at fertilisation. This website has excerpts from established medico-scientific books/literature.

Kindly note that among studies criticised by other researchers (eg Docs 2 and 3) are those of Cecilia Berger et al and Gemzell-Danielsson et al. Hence, if these papers were presented to the Committee as evidence that emergency contraceptives do not negatively affect implantation of the embryo, they should be thoroughly scrutinised and assessed before a decision is taken. Kindly note that biopsies/tissues used in in-vitro studies are not representative of in vivo uterus/endometrium and related environments. Some of the researchers who carried out these studies admit this when stating the limitations of their study – which in my view is quite a substantial limitation.

I am also finding it very hard to understand why Prof. Serracino Inglott is focusing his arguments on levonorgestrel-based products only (which were also shown to have post-conception negative effects – see doc. 3 above), while ulipristal acetate-based drugs (which have been shown to have very similar mechanisms of action to abortive drugs – indeed these may be taken up to five days after sexual intercourse – five mornings-after pills! – see docs 1,3, and 4) are being ignored, not mentioned, and forgotten – bamboozling! Apart from this, if potentially abortive drugs are already on the market, and if medical doctors are giving overdoses in order to have an EC effect (as stated in the article), two wrongs, or rather three, don’t make a right. Hence, these malpractices far from justify the introduction of EC’s on the market. On the contrary, regulators have the responsibility to stop the wrongs which are already being done.

Other “experts” and EC lobbyists also had the audacity to say that ulipristal acetate pills cannot be abortive because they contain the hormone progesterone, when these pills have anti-progesterone effects! If this is not incredible, what is? Others said that life begins when the nervous system develops – well one may have a brain but be devoid of a mind.

Jean Pierre Fava, Dip., BSc (Hons), MSc. HSC.