Medical-pharmaceutical aspects of the human embryo
Gonzalo Herranz, department de Humanities Biomedicas, University of Navarra.
discussion paper at congress International: The beginning of life. Identity and status of the human embryo.
Centro Universitario Francisco de Vitoria. Madrid, 15 and 16 February 1999.
The two models of ethical analysis
1. Pharmacological risks to the young embryo
2. The pharmacology of the maternal-embryonic dyad
3. The ethics of counter-consumption
4. The clinical-pharmacological research in the first two months of pregnancy
5. The obligation to provide information on the embryo
I believe that my first obligation is to determine the content that I can give to the topic that has been entrusted to me. Because by medical-pharmaceutical aspects of the human embryo many things can be understood, perhaps too many. And as to who the human embryo is and how long its life lasts, there has been, there is and there will continue to be discussion and confusion.
The first thing, then, is to situate, in time and space, the human embryo of which I am going to speak. There are many opinions on the temporal limits of the embryonic stage of the prenatal development of man. General dictionaries give us different versions of them. However, they are not far behind, in variability and indeterminacy, the medical dictionaries and, surprisingly, the treatises on human embryology.
Several factors have contributed to this division of opinion:
a. Two ways of counting time in the prenatal life of man are in use: one, gynaecological, computes it from the first day of the mother's last period; another, embryological, computes it from the calculated moment of fertilisation (there is a difference of two weeks between the two);
b. The introduction by some of the fictitious notion of pre-embryo1, which entails the subtraction of two pre-embryonic weeks from the length of the embryonic period; and,
c. Finally, the lack of agreement on the criteria marking the transition from embryo to foetus, as some want to assign to the embryonic period the first complete trimester of the three trimesters of pregnancy, while others prefer to use as a dividing mark the end of the second month, at which time the outlines of the organs are already established and the main external features of the body are outlined.
Let us follow the latter view, and fix the duration of the embryonic stage of the human being at the time from the moment of fertilisation to the end of the eighth week. It is possible today, in human clinical practice, to determine this age almost with daily precision. So let us count these 56 decisive days of our existence as post-fertilisation time, because in this way we count the direct, real, not symbolic or manipulated time of the most dizzying phase of our life.
Dizzying, because the embryo, in the course of this time and in the mother's womb, goes from a single-celled embryo to a figurine with a human face, measuring 30 millimetres between head and buttocks. It already has long limbs, bent at the elbows and knees, and its hands, as well as its feet, made famous by pro-life activists, already have splayed toes. In the cavities of his body, the outlines of all the organs have already been formed. All this can only be achieved in the mother's womb. And that is the embryo we are dealing with.
At the request of the organisers, we must do so from the perspective of the doctor and the pharmacist. What are the medical-pharmaceutical aspects of the human embryo? To avoid any repetition of what was said yesterday and this morning and what will be said this afternoon on fundamental and evolutionary embryology, on Genetics of development and experimentation, and on the status (biological, ethical, anthropological, legal, political) of the embryo, I will place myself in the role of a general practitioner, concerned with medical ethics, to see it in its natural presentation , in its mother's womb, and try to understand it as my patient. I will say things that may also be of interest to the pharmacist who, behind a pharmacy counter, has to professionally guide the relations of the pregnant woman and her embryo with drugs.
The embryo in the mother 
In the classical clinical status , the embryo makes little noise. The relationships that the embryo establishes with its mother and the doctor during the eight weeks of its rapid development degree program are not very explicit. Although the embryo usually makes its presence known as soon as it is a couple of weeks old, when the woman notices the absence of her period, the signals it emits to reveal its presence often go unnoticed or are misinterpreted.
In the clinic, the embryo appears before the doctor through its mother. What relevance should the doctor give to the embryo? This is an important question. If by patient we mean a human being who, regardless of his or her state of health or illness, enters into a professional relationship with the physician, the physician must ask himself or herself which patients should he or she see when attending to a woman carrying an embryo in her womb? Theoretically, the answer could be one or two, unless we are dealing with a multiple gestation.
In the medical internship and until not so long ago, the dominant answer was that only one. In the clinical context, the human embryo was, from the beginning of time until two or three decades ago, an unknown, silent, hidden being. One could only indirectly suspect its presence. Only later, when the foetus was about four months old, did it give the first unmistakable signs of its presence, when it began to move with sufficient intensity for the mother to notice it was alive. The equation between perceived foetal movements, foetal life and a certain awareness of gestation has left traces in morality, law and general culture that have not been erased.
The embryo, the human being less than 56 days old, although capable of very clumsy movement, is not sensory perceived by the mother. It is so small and so protected that the classical doctor could neither palpate it with his hands nor auscultate it with his phonendoscope. The embryo tended, of itself, to remain irremediably absorbed in its mother. This is why, in the past, the doctor, because of his enforced lack of certainty, felt a mixture of respect and perplexity towards the woman of childbearing age, because he could never be sure whether she was pregnant or not. Unable to establish a direct professional dialogue with the embryo, he tended to regard the fertile woman as his only patient, a complex patient, of which the embryo might be an integral but unperceived part.
Advances in medical technology, however, have changed the picture. First, there was the early diagnosis of pregnancy, which has evolved from primitive and rudimentary biological techniques to modern and reliable immunological methods, both the highly sensitive ones used in the laboratories of research and those used in pharmacies to confirm hopes or suspicions. Then came ultrasound techniques, with increasing resolution capacity, which made the mother's body transparent and allow us not only to visualise the embryo, but also to measure it, examine its interior, diagnose some of its illnesses, and detect its anomalies.
The biological relationship between mother and embryo remains, and will always remain, the same. But the new technologies, by revealing the presence and making the embryo visible, extend in time and intensity the psychological experiences of the mother, and create new professional relationships and ethical responsibilities for the doctor. Paradoxically, and from an extremely radical feminist sector, these new relationships have been considered as a negation or devaluation of the subjective, naturist experience of pregnancy and of the whole maternal-fetal relationship2.
Now, the doctor not only suspects the embryo. He sees it. And not only the doctor. The use of high-resolution endovaginal probes in sonography has made it possible to observe the human embryo when it is 7 millimetres long and 40 days old. By the end of the eighth week, "even the least sophisticated observers (the pregnant woman and her husband) can recognise the baby".3 Even earlier, the doctor can record its cardiac activity and follow, in the mother's blood, many biochemical, immunological and cellular markers of its activity and presence. The embryo is there and challenges us.
The two models of ethical analysis
Thus, depending on the circumstances, historical or technological, it is possible for the doctor to see, in the pregnant woman, one or two patients. The same is true in the medical-ethical context.
In American medical ethics, so closely tied to the legal, so dependent on what judges say, two models have been constructed, the unitary model and the maternal-fetal dyad model, as framework for reference letter of obstetric ethics4. The two models offer different options to determine to what extent the pregnant uterus is a "public space", a place of human interaction, in which to assess whether or not judicial interventions are justified for the protection of the future child from the risks derived from the mother's illness, way of life, work or entertainment; or, on the contrary, it is a private and exclusive enclosure, where only the woman reigns with almost absolute power. In the American ethico-legal perspective, the models serve to discuss when and under what conditions it is possible to order a necessary treatment to cure or prevent an illness of the foetus itself, to protect it from maternal illnesses (diabetes, infections) or from the damage caused by the mother's pathogenic lifestyles (alcohol, illegal drugs, sexual activity), or to save it from high-risk obstetric situations (caesarean section).
The two models have usually been used for situations affecting the foetus at the end of gestation or immediately before birth. It is worth reflecting on their relevance for the doctor's relationship with the pregnant woman and her embryo. But first, it is worth taking a look at the more general features of each model.
For the unitary model , there is only one capable and competent patient before the doctor: the woman. The embryo is in her, but it is part of her body. She determines the importance given to the embryo. She regulates the flow of information that circulates between embryo and physician and filters through her agency the decisions that are made regarding the maternal-embryonic unit. The physician has an ethical obligation to promote the well-being of this unit, advising and prescribing, but does not enter, so to speak, into a direct dialogue with the embryo, because the mother speaks for herself and her embryo. The doctor has no rights or responsibilities that bind him directly to the embryo. Rather, they are mediated, indirect and subordinate through the organic whole that is the pregnant woman.
In the unitary model , scientific data and evidence-based criteria play a secondary role, because they do not determine the final decision to be taken. The skill to decide is concentrated in the sole autonomous agent, who is the pregnant woman. The physician must respect what the woman decides and, out of professional loyalty to her, should not, in critical situations, allow his capacity for committee and persuasion to be replaced by the coercive intervention of a judge. At the very least, he should not take the initiative for apply for the intervention of the public prosecutor. In a typical interpretation, the American Medical Association association states: "By apply for a court order, the physician is depriving the pregnant woman of her right to accept personal risk and substituting her own judgement staff about the amount of risk that is acceptable for her. Such a course of action undermines the very foundations of free and informed consent."5
In contrast, at model of the maternal-fetal dyad, there is a tendency to see the embryo and foetus as a patient, genuine and individual, whose welfare and rights appeal directly to the physician. Obviously, the doctor cannot be blind to the welfare and rights of the pregnant woman. He must take them into account, for they are necessary for him to be able to treat the mother, who is always one of his two important patients. The physician can no longer consider only the overall effect of his treatment on the combined unit of mother and embryo, but must consider in a unique way what is best for each of his two unique patients.
The embryo's access to the status of patient can enrich in an extraordinary way, and also complicate, the decision-making process, because it doubles the doctor's responsibilities, and makes them much more explicit in concord and in conflict. On the model of two patients, situations where the autonomy of the mother and the benefit of the embryo clash do not have a predetermined solution, but have to be source of much reflection and constructive solutions. As Tauer6 points out, Catholic institutions usually subscribe to the two-patient model , because it allows a stronger advocacy in favour of the embryo, which is an imperative of charity, and a very strong professional argument to refute abortion.
What a great pity that the knowledge we have of the human embryo is so often scorned, even banned! In my view, one of the greatest miscarriages of justice of all time was the decision of the Supreme Court of the United States when, in 1983, in the lawsuit of a reproductive health centre against the municipality of Akron, Ohio, ruled that showing a woman seeking an abortion a photograph of an embryo the age of the one she intended to destroy or showing her a live ultrasound image of the living embryo she was carrying was not only an illegitimate way of providing information for consent to abortion, but an assault on liberty, a parade of atrocities, a sample of ideological torture. Never have the data that science is capable of revealing been more brutally disregarded7.
There is no doubt that the nascent embryo-fetal medicine will develop much more vividly under the dyadic model than under the unitary one. After all, the promotion of the embryo to the status of patient was not result due to a change in its biology or in the biology of the pregnant woman, but to the fact that doctors have "discovered" it thanks to their new technologies and research. Thanks to them, the words that Psalm 139/138 preaches about God and which head one of the epigraphs of Evangelium vitae: "Your eyes have seen my embryo", have also become a reality for men.
This greater technological capacity to know and diagnose, places on the shoulders of clinical embryologists the stupendous burden of developing a scientific and humane embryo-fetal medicine, founded on the living awareness of the humanity of the embryo. It is precisely from this conjunction of science and respect that the specifically medical contribution to the culture of life is born.
Now is the time to pay attention to topic de
Pharmacology of the embryo
The relationship between the young embryo and drugs is a very interesting chapter in medical ethics. source They are an inexhaustible source of conflict, but they are also a source of therapeutic possibilities. There are very special circumstances here. The peculiar biology of the embryo creates, so to speak, a specific pharmacology, very closely linked to the dyadic model : a pharmacological action beneficial to the mother can have undesirable effects on the embryo. But, at the same time, the installation of the embryo in the maternal-embryonic unit implies the unavoidable condition that we can only act pharmacologically on the embryo through the maternal organism. These peculiar and difficult relationships have led to classify, in the context of clinical pharmacology, the pregnant woman and her embryo in the category of vulnerable subjects, a disadvantageous status , which the tragedy of thalidomide has ensured to endure.
Logically, I will treat subject, with extreme brevity and from a medical-ethical perspective, in five points: 1. the risks of drugs for the young embryo; 2. the pharmacology of the maternal-embryonic dyad; 3. counter-consumption; 4. the clinical-pharmacological research in the first two months of gestation; and 5. the duty to take the embryo into account when informing about consent to treatment.
1. Pharmacological risks to the young embryo
Although the drugs a pregnant woman receives can harm her child throughout prenatal life, the embryonic period is the time when their harmful effects can be most significant. All doctors have been taught at Schools that the ideal is not to prescribe drugs during pregnancy, especially in the first three months.
But following such an indication would often be tantamount to depriving pregnant women of effective and harmless drug treatments. Why so many restrictions? Is there any basis for them?
It seems to be so. First of all, because the young human embryo possesses a peculiar biology, which determines its peculiar sensitivity and reactivity to drugs. The young embryo has not yet developed, or possesses only in a very rudimentary state, the mechanisms through which, in postnatal life, drugs are managed to exert their effects. The embryonic organism itself and its young placenta have not yet developed some of the molecular and cellular Structures for the uptake, metabolisation and elimination of many drugs. They cannot exert their specific actions on effectors that have not yet developed or matured sufficiently Degree .
They can, however, cause harm. The spectrum of pharmacodynamic reactions in the embryo is very narrow. Either the drugs have no effect on the embryo, often because the placenta is impermeable to them, or, if they are active, they interfere, not with highly differentiated functions, but with the basic functions of the embryonic organism, which are cell proliferation and differentiation of the outlines of organs. The consequences are easy to understand: some are general and non-specific, such as embryo death and miscarriage, or global growth deficiency with reduced birth weight; others are focal and specific, constituting the many different types of malformations or local disorders of development. This is teratogenic toxicity.
The embryo's susceptibility to drugs varies with its age. And it is different for different drugs. In the first two weeks, the embryo is relatively refractory to malformations. Under the effects of drugs that harm it, of anti-cancer agents given to the mother, for example, the embryo can suffer cell losses which, if they do not exceed a certain level, can be compensated without consequences thanks to the formidable repair capacity of its toti- or pluripotent cells; if the damage exceeds a certain threshold of intensity, it can cause irrecoverable lesions that lead to its death.
The period of maximum teratogenic sensitivity extends from the third to the eighth week. This is the most feared phase, when drugs can cause malformations. Within these five weeks, teratogens usually act at a specific time, which we call the critical period, and which lasts a few days, or even just a few hours, for each drug. The same is true for malformations: each malformation occurs at a specific time. Different drugs, if they act at the corresponding critical time, can induce the same subject malformation. But it also happens that certain drugs regularly cause certain isolated malformations or malformation complexes: we then speak of malformation syndromes, such as those caused by thalidomide or hydantoin, for example.
2. The pharmacology of the maternal-embryonic dyad
The implantation of the embryo in the mother's womb is therefore source of pharmacological and ethical conflicts. For the time being, the vast majority of these conflicts go unnoticed, because the vast majority of women who become pregnant do not go to the doctor until at least six to eight weeks after fertilisation, when the period of organogenesis is either well advanced or already over. This will probably not be the case in the future. There is a strong social tendency to "medicalise" pregnancy, to go to the doctor in the periconceptional period, in order to put on internship preventive measures for certain malformations, through the intake of vitamin supplements8. Mothers, as another aspect of their reproductive control, will want to be prepared to maternally welcome the embryo.
The above suffices to support the conclusion that, in the context of respect for nascent life, there are, in the mother-embryo dyad, certain ethical-professional duties of the doctor and pharmacist when prescribing and dispensing medicines to women of childbearing age and, above all, to pregnant women9. The physician should refrain from prescribing potentially teratogenic drugs and offer non-teratogenic alternative drugs that are similar in efficacy and safety. If there is no alternative and the maternal disease, because of its severity, must be inexcusably treated with a teratogenic drug, it must be given at the most effective dose leave, as many teratogenic effects are dose-dependent. In cases where teratogenic drugs are of only marginal benefit or where the nature of the disease permits deferral of treatment, it is ethically obligatory to defer therapy until organogenesis has been completed and there is no longer an appreciable risk of inducing malformations. For diseases that require continued treatment, non-teratogenic drugs should be used before conception and during the first trimester and switched to other drugs during the remainder of the pregnancy.
However, despite all due caution, it will not always be possible to avoid a few cases of inadvertent, accidental or unavoidable exhibition to teratogenic drugs. There are drugs, such as some vitamin A analogues, isotretinoin, for example, that maintain their teratogenic action for months. If their administration is suspended, it is possible to avoid some of their adverse effects. And there are drugs that cannot be discontinued continuously, such as some antiepileptic drugs, as fail treatment could lead to serious effects10. In these cases, the imperative to do no harm obliges the doctor to seek the right balance between the treatment of the mother's illness and the preservation of the life and health of the embryo, as he/she has a moral responsibility to protect the embryo and to avoid serious harm resulting from exhibition to these drugs11.
Physicians and, to the extent that it is their duty, pharmacists should always be guided by sound scientific data , not by anecdotal data that may induce an unfounded anti-therapeutic attitude12. Even today, the sombre memory of the thalidomide tragedy continues to exert a pessimistic effect on the general assessment of drug teratogenicity13.
We must bear in mind that, in the context of the maternal-embryonic dyad, it is not only the mother who can become ill. The embryo can. If the embryo becomes ill, it must be treated. The Code of Medical Ethics and Deontology of the Spanish Medical Association14 states in its article 25.2 that "The sick embryo-fetal human being should be treated at agreement with the same ethical guidelines, including the informed consent of the parents, that inspire the diagnosis, prevention, therapy and research applied to other patients". The doctor must advise the pregnant woman, when the prevention or cure of an embryonic disease so requires and for the good of the embryo, the application of medicinal treatments, the adoption of dietary measures or the modification of lifestyle, even if this requires some renunciations and sacrifices. It should not be forgotten that most mothers are usually willing to sacrifice some of their safety, lifestyle and health for the well-being and safety of their children15.
However, there is no shortage of those who believe that the autonomy of the pregnant woman should not be sacrificed in order to satisfy the health needs of the embryo. They use much more legal than ethical arguments to argue that the mother is under no obligation to suffer so that the necessary medical care can be provided to the embryo or foetus. If she did, they say, she would be reduced to the passive role of a foetal container, which she opens in order to gain access to the child, even at the risk of damaging the container16. Enthusiasm for nascent embryo-fetal medicine has also been criticised, as it could offer strong support for the right to life of the unborn, a right that may collide, especially when the mother has taken certain risks, with the legally recognised right to abortion17.
Fortunately, mother-embryo relations remain a more endearing and humane field of gravitation than the cold analysis of conflicting rights by the cult of death. Undoubtedly, the future development of embryofetal medicine and surgery, both curative and preventive, will increase opportunities and conflicts. It is to be hoped that the more or less important servitude that the protection of the health and wellbeing of the embryo or the treatment of its illnesses requires of the pregnant women will be rendered with the love and availability of a mother. Let us not forget that in our language, to gestate is to carry and sustain the mother in her womb the living fruit from conception to the moment of delivery.
This time, from conception to delivery, tends to be extended to include the preconception period, the days immediately preceding fertilisation. This time has become a time of high pharmacological temperature. It is the time when drugs that try to prevent the onset of certain errors of the development and in particular neural tube closure disorders must be used. But it also, and paradoxically, includes the days when counter-gestational drugs or poisons act, which try to destroy the newly conceived embryo, either by intercepting the mechanism of nidation or by acting as abortifacients of the embryonic phase.
3. The ethics of counter-consumption
The history of the pharmacology of hormonal contraception points to a clear evolutionary trend: its point of action has been shifting from the woman to the embryo. It started out as anovulatory: the first generation pill tried to prevent ovulation with the clear aim of preventing fertilisation, purpose , and achieved this at the cost of its high hormonal content. Now it does not exclude interceptive action: it is no longer of interest to interfere with ovulation, as it is more effective to prevent the nidation of the embryo. And if nidation has already taken place, it can be eliminated by means of the abortion pill, which is most effective against embryos of less than 8 weeks. From contraception we have moved on to contraception.
When Baulieu18 coined the term counter-management, he did not do so to designate the action of RU 486 in a new way. With the neologism, he was trying to banish the idea of abortion: "My purpose - he wrote - is to eliminate the word abortion, because this word is as traumatic as the fact of abortion itself". But he was also interested in highlighting the fact that the abortion pill is not, as an abortifacient, a novelty in the field of birth control. Many methods of fertility control," he said, "are not contraceptive in the common and accepted sense of the term. In the case of intrauterine devices, hormonal contraception based on gestagens and postcoital contraception, we are dealing with a post-fertilisation interruption, which would have to be considered as abortifacient. [...] For this reason, we have proposed the term 'contragestation', a contraction of 'contra-gestation', to include most methods of fertility control.
In a sense, the contraceptive arc is now closed. A very recent work on the contraceptive efficacy of mifepristone states: "A dose of mifepristone leave , which does not inhibit ovulation, significantly reduces fertility by altering the endometrium "19. Endometrial contraception is seen as a promising and very attractive way forward, as it will leave ovarian function intact and will leave the course of the menstrual cycle virtually undisturbed. The cost of contraception will be entirely borne by the embryo position and will be physiologically free of charge for the woman. And also in the ethical-social aspect: to appease consciences, endometrial contraception is spoken of, as if it had nothing to do with the embryo. But it should not be forgotten that the pharmacology of endometrial contraception seeks to alter the endometrium minimally as far as the woman is concerned, but makes it inhospitable as far as the embryo is concerned. Taking advantage of the increasingly precise knowledge of the continuous and sophisticated molecular dialogue between mother and embryo, the aim is to specifically alter the expression of certain factors that are necessary for implantation. The result is the inhibition of blastocyst implantation20.
As a perverse derivation of the dyadic model , the aim is to make the embryo the sole target of the new contraception, be it hormonal, immunological or other subject. The latter aims to interfere little or not at all with the woman's physiology, in order to concentrate all the effect on the young embryo. In this connection, it is worth recalling that the list of areas justifying the research on in vitro embryos included, from the beginning, the development of new contraceptive methods. In 1985, a article publishing house in the Lancet21 commenting on the Medical Research Council's response to report Warnock, pointed out that the knowledge that could be obtained from research on in vitro embryos "could have as great an impact on the control of reproductive activity as the contraceptive pill has had".
4. The clinical-pharmacological research in the first two months of pregnancy
The embryo and foetus, as well as the pregnant woman, still deserve to be called "the orphans of an expanding therapeutic approach"22. 22 To see this, one need only read the package leaflets that manufacturers put on the packaging of medicines. They often say things like: "There is no data about its possible effects on pregnancy. It should not be administered to pregnant women".
The embryo and its mother are the disinherited of today's pharmacopoeia, because they have been excluded from the clinical-pharmacological research . They constitute one of the so-called "special populations", which are tacitly prohibited from being included as subjects of research in clinical trials. The need to defend them from potential risks and abuses has put them on the margins of many therapeutic advances. Their safety has been paid for with ignorance.
report Such a status is, to a large extent, a sequel to the Thalidomide tragedy, the memory of which is still very much alive in the minds of those working in the pharmaceutical industry and in the drug control agencies. Those responsible for drug safety decided that a catastrophe of such proportions should never be repeated and took the drastic measures to prevent it, which have led to therapeutic orphanhood.
And yet the fear of drug-induced teratogenesis was rekindled when it was later found that diethylstilbestrol, administered precisely to avert the threat of miscarriage in the early stages of pregnancy, was the cause of vaginal cancer that appeared decades later in the daughters of women treated in this way.
If we add to these unfortunate episodes the doctor's fear of being sued for malpractice internship if he is accused of having induced a disorder of the development and, above all, the panic of the pharmaceutical industry at the moral and economic effects of a massive lawsuit for damages attributed to one of its products, it is understandable that it has become a general rule to avoid, during pregnancy, the consumption of medicines except in cases of absolute necessity.
This is the official doctrine, the current rule : "If possible, no medication should be taken during the first trimester of pregnancy. In addition, the benefits and risks of taking medicines throughout pregnancy and childbirth should be carefully weighed". So begin the guidelines of the December 1986 Update of the Committee on Safety of Medicines and the Committee on Review of Medicines23.
In the face of such alarmist recommendations, what is actually happening?
Women pay little attention to them. In a review of the problem, Quirk found that 60% to 75% of pregnant women take 3 to 10 different medicines during pregnancy24. 24 Other studies show that pregnant women not only do not abstain from taking medicines, but also take non-prescribed medicines and that 40% of them do so during the first trimester25.
Fortunately, efforts are being made to remedy this status gap. The marginalisation of women, particularly pregnant women, from biomedical research has been denounced as a historical injustice26, and steps have been taken at the institutional level to ensure that women and men enjoy equal opportunities to share in the benefits and burdens of research27. This balance will not be easy to achieve, as data indicates how costly it is to overcome the pharmaceutical industry's resistance to sponsor research where women may incur reproductive or teratogenic risks28.
Let us imagine, for a moment, the future, when the necessary mastery of gene therapy techniques in somatic cells has been achieved plenary session of the Executive Council and we are faced with the challenge of whether or not to apply them to germline cells in order to cure hereditary diseases, not only in the patients who suffer from them, but also in their descendants. One thing is clear: for the promises of germ line gene therapy to be realised in a truly human context, it is an unavoidable ethical requirement to apply them in accordance with the norms demanded by the respect for nascent human life and the dignity of procreation, precisely expressed by the Instruction Donum vitae29, and then confirmed by the Catechism of the Catholic Church30 and, finally, by the Encyclical Evangelium vitae31. The ideal candidate to which this therapy is to be applied will undoubtedly be the unicellular or very few cell human embryo, fruit of the act of love of parents, which the doctor will retrieve from its mother's tube, treat it in vitro, and return it, cured, to its mother's womb.
This positive attitude contrasts sharply with the negativism of some institutions that consider the human genome to be intangible in the face of modifications that can be transmitted hereditarily, as well as with the merely pragmatic positions that are impervious to the message of respect for the life of the embryo and the dignity of procreation.
5. The obligation to provide information on the embryo
I would like to conclude by referring to a typical pharmaceutical and medical aspect of their relations with the embryo: they need to take it into account, they need to talk about it with its mothers. They need to refer to it as a human being, when informing their patients in prenatal consultations, and, above all, when prescribing and dispensing. It is important to discuss the safety and risks of medicines in the first two months of pregnancy.
But this is rarely done. There seems to be, in many medical and pharmaceutical circles, on the professional internship and on research, a conspiracy of silence around the embryo in the mother's womb. It is preferred to forget it or to cancel it out, with the purpose of download the ethical tension of embryonic destruction of contraception and assisted reproduction.
To achieve this, a redefinition of concepts and the circulation of a new language has been used, which "refutes the misconceptions and misinformation that, in the past, have obfuscated the whole question of the mechanisms of contraception". The light that sheds light on the problems comes with the precise (re)definition, based on scientific data , of the terms 'gestation' and 'abortion', redefinitions that are endorsed by certain politico-scientific corporations, probably more interested in giving apparent dignity to professional routines than in clarifying the reality of the facts. For example, the authority of a dictionary, published under sponsorship of the ACOG (the American College of Obstetrics and Gynecology), , which defines conception as the implantation of the blastocyst and is therefore not synonymous with fertilisation32. Gestation is defined as the state of the woman after conception and until the termination of pregnancy. The new definitions received the blessing of FIGO (the International Federation of Gynaecology and Obstetrics), which had been commissioned by the World Health Organisation in 1985 to develop a precise definition of gestation. It offered this: "Gestation is established only with the implantation of the fertilised egg "33. From agreement with the preceding definitions of conception and gestation, abortifacient agents are only those that act to interrupt gestation after implantation. The pre-implantation period of the embryo has been left out.
What is serious is that the lexical redefinition has been elevated to the status of a hard and unappealable biological fact: "The biological fact is that gestation begins with implantation and not with fertilisation. When a fertility regulation procedure works before implantation, it is ethically and medically important to explain to patients that the method is not abortifacient. We understand that there may be differing opinions about when gestation begins, but [...] such beliefs cannot change the biological process involved "34.
The human embryo in its first week is thus cynically relegated to the sad status of the "disappeared". Their destruction does not appear in the official catalogue of ethical conduct. This is an aggressive, unscientific, manipulative attitude, because it is not based on observation of the facts, but on their partial, capricious and wilful suppression.
We need to talk a lot, and with a lot of love, about there being two cultures. A culture of life, which implies respect and wonder, veneration and celebration. When we consider the profound reality of life," said Blessed Josemaría Escrivá when he conferred the Degree of honorary doctor on Professor Jérôme Lejeune, "its noblest affections escape from the heart. With what love, with what tenderness, with what infinite patience do parents look at their children even before they are born!"And he added: "Or is it not also hopeful expectation, a capacity for intuition, a sharpness of wit, that of the doctor who applies the most modern remedies to avoid the risk of a congenital illness, perhaps endangering the life of the unborn child?"35
How poor in comparison the culture of death appears to us, with its exercise of possessive dominion over man, its manipulation of concepts, its violent aggression towards the weakest, even its pretended right to say who is scientific and who is not!
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