I am not going to reply to Prof. Anthony Serracino Inglott’s letter in last Sunday’s TIMES entitled Emergency Contraception in the sarcastic way that he wrote about me, in deference to boring the public to death with medical details. I will simply point out that there is a wide gap in the pharmacological specifications that he himself has felt fit to quote.
In the specifications for Levonelle 1500 micrograms (levonorgestrel) he quotes that “at the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is highest. Levonelle 1500 is not effective once the process of implantation has begun”. What if it has not yet begun? It is evident that in the specifications themselves there is a lacuna or hole which Anthony Serracino Inglott seems to be playing on!
What if implantation has not yet begun – can it be prevented from beginning? What happens between fertilisation in the fallopian tube and the around five to seven-day period before the embryo comes to implant in the uterus? There is a glaring omission here and a profound silence! What exactly does one expect if the indications of the drug concerned is to cause the prevention of pregnancy? Is the literature incomplete for any particular reason? What about prevention of the beginning of implantation which is nowhere to be reckoned in the SmPC that he himself quotes?
As I wrote in my original article, there is much conflicting medical literature on the effects of levonorgestrel after ovulation has occurred, as to whether there is a prevention of implanatation of the embryo or not. Some studies and medical literature say it does prevent implantation of the embryo, some others say that there is no evidence that it does so (no concrete evidence that it does not do so). Nobody knows what vested interests are behind these reports as nobody knows what the vested interests are behind some of the opinions here in Malta.
Now every person with common sense knows that if there is serious doubt as to whether or not something is going to damage a human being, one does not approve it unless one is certain of what is happening. This is the primum non nocere of the medical profession. One of the first principles of medicine is, first, do no harm! If there is substantial doubt as to the action of the drug with respect to human damage (to the embryo), then the onus of proof would be on the prescriber and authoriser of the drug. If I remember well, there were several people who, during the parliamentary sub-committee hearings, attested to the negative effect of Levonorgestrel leading to the embryo failing to attach to the uterus. Apart from Professor Brincat, who testified the way he did (he also thinks that human embryos should be frozen during IVF procedures), there was another consultant gynaecologist who also testified to the damage caused by Levonorgestral to the embryo after ovulation occurs – or is Professor Serracino Inglott conveniently forgetting this too?
He takes me to task because I corrected myself about the drug Ulipristal (progestogin modulator) where, if anything, I accepted that, like Levonorgestral, it may be used before ovulation, but from the beginning I always said that like Levonorgestrel, it should not be used after ovulation. I have always been consistent on this particular point. As for the Italian Bioethics Committee, my answer is, where is the properly constituted Maltese Bioethics Committee? I can only wish that we had a Bioethics Committee that functions like the Italian one, composed of prestigious experts from all fields and which issues profound majority and minority reports on the relevant biomedical issues. It may not mean that I agree with all the Italian Committee’s reports but that is another thing.
Our Maltese bioethics committee is a practically non-existent and non-functional one and was never adequately constituted by this government with academics from the various disciplines, because it does not behove this notoriously subjective government to have a truly functioning committee to objectively advise it about these issues. Just as in the environment and in other quarters, this government has its own reasons and political agenda for not getting objective opinions published or acting on them if they are – and truth is often the first casualty.
I have been practicing my profession for 33 years and, like all doctors, I know that when treating patients one must not only consider the science but also the human circumstances surrounding that person, because applied medicine involves a knowledge of human psychological, social and philosophical issues that also need to be weighed in the balance of the final decision: a ‘feeling’ for the profession that general practitioners and other physicians learn not to ignore, a feeling based on facts but not only of the scientific kind! Medicine is both a art and a science: a science like the ovulation tests often used by patients to determine whether they are ovulating or not in order to determine their fertile period. An art like deciding when to treat a patient who is the victim of a rape or incestuous behaviour!
As for Minister Helena Dalli, she should not just rely on the Medicines Authority for an opinion. One swallow does not a summer make! She should have a wide access to other professional opinions and authorities too, unless of course it might suit her to rely on just one opinion in order to advance her ‘civil liberties’ agenda!
Dr. Michael Asciak MD, M.Phil. (European Studies and Genomics), PhD (Bioethics), PGC in VET. Senior Lecturer II in the Institute of Applied Science at MCAST.