Drug Induced Termination of Pregnancy With Mifepristone (RU 486) and Prostiglandin
The following is an English translation of a German paper on Hoecsht AG's position regarding the importation of RU486 into any country.
It describes the mechanism by which RU486 works, some of the clinical experience, and then, the most maddening part, they try to set the moral/ethical framework for the debate by implying anyone who might be against abortion is primitive and simplistic.
Behind the veneer of courtesy is a very strong message that they don't care what pro- life concerns are. If there is a legal framework set in a country who would receive the drug, then they'll sell it. Also, their company policy which is explained below, claims to require a cultural consensus in the country before it will bring it to that country, however, that is certainly not the case in the US, but they did it anyway. They are groping for justifications and policies to rationalize the production and sale of RU486.
This is a long piece, but worth reading as it's from the "source". It's also worth reading in order to learn what the real attitude of this company is.
Landon
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Translation of the third edition of the German brochure
"Der medikamentose Schwangerschaftsabbruch mit Mifepriston (RU 486) und Prostaglandin"
N.B. Please note that graphics printed on page 6 of the original brochure are not included in the translated text.
DRUG INDUCED TERMINATION OF PREGNANCY WITH MIFEPRISTONE (RU 486) AND PROSTIGLANDIN
Information from Hoechst AG
Pharmaceuticals Division, Health Policy Department
Third, expanded edition: July 1992
This publication, now presented in a revised edition, was published for the first time in May 1991 and updated in October 1991. With it, HDECHST aims to inform the general public in Germany and abroad, as well as our shareholders, customers, business partners and staff, about drug-induced termination of pregnancy with mifepristone, and to provide an insight into the complex issues that have led to company policy decisions.
In the past year, the information provided by Hoechst has noticeably influenced the intended communicative process both in- and outside the company.
Conversely, the realizations and results obtained from numerous discussions with representatives of various social groups from Germany and abroad have been included in the revised edition.
The compilation of these experiences will hopefully serve to promote the discussion started on the existential question of man's being.
HOECHST thanks all those who have participated in the discussion to date and not least those who view this publication as an invitation to an open dialogue with HOECHST.
TABLE OF CONTENTS
Discovery and properties of mifepristone (RU 486)
The use of mifepristone
Responsibility of the manufacturer
The legal situation in the U.S. and in the Federal Republic of Germany
Development and situation in France
Development and situation in France
Principles of company policy
First company-policy principle
Statutory rulings
Societal consensus
Deficiencies in societal debate
Second company-policy principle
Third company-policy principle
Concluding remarks
Discovery and properties of mifpristone (RU 486)
At the beginning of the 1980s, hormone researchers at the French company Roussel Uclaf made a discovery that would soon put Roussel Uclaf and its parent company, HOECHST AG, in media headlines around the world.
Mifepristone as an anti-progesterone
Although the research work absolutely did not originate with the goal of pregnancy termination in mind, in cooperation with INSERM, the French National Institute for Health and Medical Research, researchers realized that the synthetic substance mifepristone (RU 486) is capable of acting in all reproductive processes against the natural hormone progesterone, which is necessary to maintain pregnancy.
When pregnancy starts, progesterone ensures that the fertilized egg or embryo is properly implanted in the endometrium and that the right conditions are created to make the embryo viable.
Mifepristone occupies the site intended for progesterone in the receptor, the link between this hormone and the uterus. In this way it blocks progesterone and prevents it from exerting its effect. That is why mifepristone is called an anti-progesterone.
[Schematic representation of the mechanisms of action of a hormone and an anti- hormone]
Combination with prostaglandin
The result is that the endometrium breaks down and the fertilized egg or the embryo is expelled. This is accelerated by the administration of a prostaglandin, a substance which induces uterine contractions. The abortion progresses like a spontaneous miscarriage.
[The action of progesterone in the uterus - schematic]
The action of mifepristone (RU 486) in the uterus
1 initiates breakdown of endometrium
2 detachment of embryo
3 decline in HCG
4 atrophy or corpus luteum
5 decline in progesterone
6 further breakdown of endometrium
7 enhanced contractility of uterine muscle
8 softening and dilation of cervix
9 expulsion of embryo and endometrium
Further application areas
The progesterone-specific blocking action of mifepristone has a number of further potential uses in gynecology: for instance in facilitating the induction of labour, therapy for endometriosis (a disorder of the endometrium) or the treatment of breast cancer and uterine fibroids (benign tumours).
Clinical studies have not been concluded for the aforementioned applications. In the meantime, Roussel Uclaf has amassed a wide range of documentation prepared by numerous gynecological centers concerning the use of RU 486 in the termination of pregnancy.
The use of mifepristone
Directions for use
Mifepristone is taken in the presence of a doctor, using a dose of 600 mg (three 200 mg tablets), no later than the 49th day (63rd day in the U.K.) after the start of the last period. Prior to taking the drug, patients must be given a week's time for counseling and reflection. 36-48 hours after the administration of mifepristone, the patient is given a prostaglandin analogue (a gemeprost vaginal suppository or misoprostol tablets) which helps with complete expulsion. A check-up is performed 8-12 days later.
Success rate
The use of mifepristone (trademark: Mifegyne) and prostaglandin is amply documented in France. The data indicate that of approx. 16,000 patients treated in 300 clinics, expulsion was complete in more than 95% of the cases, while additional vacuum aspiration was needed in the remaining cases owing to incomplete abortion (2.8%), continued pregnancy (1.2%) or heavy bleeding (0.6%).
Responsibility of the manufacturer
Mifepristone - a sensitive product
HOECHST and Roussel Uclaf are and always have been aware of the fact that mifepristone represents a product that cannot meet with the unanimous approval of society at home and abroad owing to its use in the termination of pregnancy.
Market and responsibility
As a leading international business enterprise, HOECHST is intrinsically involved in many different economic, cultural and political systems. Just as diverse are people's expectations of what the company should and should not be providing. Demand varies from country to country and even within a country itself.
Market supply and demand usually regulate themselves within the legal framework laid down by the state. This is true unless, despite statutory rulings, controversial basic interests of humans are affected which do not result in societal consensus as to whether a certain product is desirable or not. This puts the market under strain, affected as it then often is by the po1arized situation; the supplier's reaction to such a scenario must be one of caution and responsibility.
The legal controversy
HOECHST and Roussel Uclaf still find themselves in a similar situation in many countries - and particularly subject to close scrutiny in the U.S. and Germany.
The legal situation in the U.S. and in the Federal Republic of Germany
In both of these countries, the statutory rulings on pregnancy termination have been the subject of heated debate for some time now. Incidentally, clear attempts to tighten the criminal law provisions are still recognizable in both countries.
Polarization in the U.S.
On June 29 1992, the U.S. Supreme Court upheld its decision by a 5:4 majority in Roe vs. Wade, the 1973 ruling that recognized the unconditional right to abortion. The reason for the review was a Pennsylvania law that seemed to contradict the 1973 ruling because it made abortion subject to the fulfillment of certain criteria. Despite the legal restrictions (counseling by a doctor, a 24-hour reflection period, permission of at least one parent when minors are concerned), the Supreme Court did not see a violation of a woman's constitutional right to an abortion and only declared unconstitutional the stipulation that a wife must inform her husband of a planned termination.
In light of this decision, restrictive laws in Utah, Louisiana, Nebraska, North Dakota, Mississippi and West Virginia will also have to be checked for their constitutionality. In contrast, as a result of referendums held in Nevada, Connecticut and Washington, the termination of pregnancy would have remained legal in these states even if the Supreme Court had withdrawn the constitutional right to abortion.
Polarization in Germany
Since the Federal Constitutional Court's decision of February 25 1975, the debate in Germany concerning Article 218 never quieted down completely and has been heating up ever since the trial of a doctor in Memmingen who performed abortions on several of his patients. A clear consequence of the debate was the voidance petition of the government of the state of Bavaria to the Constitutional Court, the outcome of which still has not been decided.
The petition is primarily based on the rulings of the previous Articles 218b, 219 of the German Penal Code concerning counseling and the determination of indications for pregnancy termination. Both rulings are believed to be unconstitutional because they presumably do not sufficiently fulfill the constitutional requirement to protect the unborn. The so-called social indication, with which well over 80 percent of the pregnancy terminations were justified, are said to have virtually become a substitute reason for allowing abortions during the first three months of pregnancy, something that is neither legally founded nor constitutional .
These questions were raised again in the debate concerning the reform of Article 218, which had become more urgent as a result of the reunification of Germany. Pursuant to the unification treaty of October 3 l990, the legislator was called upon to harmonize the different laws on abortion in eastern and western Germany (social and medical indications in the west and abortion on demand in the east during the first three months of pregnancy) by the end of 1992. In so doing, the weaknesses of both laws would be eliminated.
On June 25 1992, a Bundestag majority, or in this case 355 parliamentarians, voted in favour of the so-called group proposal (abortion during the first three months with mandatory counseling). Two weeks later, the Bundesrat also approved the bill. After the federal chancellor (and several cabinet ministers) had countersigned the bill, the federal president executed the piece of legislation and arranged for its promulgation in the Federal Law
Gazette. On August 4 1992, the Federal Constitutional Court approved a petition filed by 248 CDU/CSU parliamentarians and the Bavarian government for a temporary injunction and unanimously agreed to stop the law temporarily from taking effect. The definitive future status of Article 218 will not be available until the outcome of the voidance petition expected for this year is final.
Development and situation in France
The introduction of mifepristone in France
The public debates in recent years that have sometimes been bitter and irreconcilable became even more intense when Roussel Uclaf (Paris) made mifepristone available at the end of 1988 after being urged by the French minister of health, who asserted that it was in the interests of public health. Faced with a split in public opinion, Roussel Uclaf initially announced that it did not wish to use its license for the drug, which had already been granted.
Strict distribution regulations in France
In France, the termination of pregnancy is undertaken only in special clinics authorized by the state. This also applies to medical termination with mifepristone, for which special regulations were issued governing distribution and use. The authorities and Roussel Uclaf jointly control the distribution of the drug, while the doctors and pharmacists in the clinics inform the patients about it, obtain their consent, and prescribe and administer the drug under carefully controlled conditions in each individual case. Distribution of the drug by pharmacies to the public or prescription by physicians in private practice are ruled out.
In the meantime, more than 80,000 women in France have opted for drug-induced termination of pregnancy within the existing legal framework rather than for the surgical method of termination. However, there is no evidence that the total number of terminations has increased since 1988.
Medical advantages
The decisive medical advantage of mifepristone lies in the fact that the health risks and the technological effort and expense associated with surgical intervention can be avoided. Included among the health risks are not only the
anesthetic, but also, and in particular, the risks of incomplete curettage, perforation of the uterine wall, infection and other complications that can later lead to infertility. Furthermore, mifepristone can also be used at an early stage of the nidation process.
Clinical experience
The clinical experience accumulated so far shows that no grave risks occur if the procedure laid down is strictly adhered to. In April 1990, a patient died in France during pregnancy termination with mifepristone and prostaglandin. As investigations showed, the ban on treatment of heavy smokers was not adhered to. Since then, only women who are not older than 35 and haven't smoked in two years may receive the treatment in France. To date, there have been no observations of negative consequences in subsequent pregnancies. In all the cases known to date, women treated with mifepristone who later became pregnant again have given birth to healthy babies.
Psychological effects
A study about the psychological acceptance of mifepristone has been in progress in France for some time now. The final results are not available yet. According to the preliminary survey results, most women viewed the medical alternative positively. Approximately 30 to 35 percent of the French women seeking an abortion decided in favour of mifepristone.
Principles of company policy
Three reasons for a special approach
In contrast to conventional drugs for which approval is applied for directly from the competent authorities after successful clinical testing in accordance with the legally stipulated practice, HOECHST and Roussel Uclaf deliberately selected another route.
This was done for three reasons:
o In the eyes of the public, the medical indication of pregnancy termination does not represent a simple illness like any other for which the patient is given a prescription in order to recover.
o The statutory rulings on pregnancy termination are in a state of public controversy despite (or precisely due to) the existing laws and regulations, judicial and legislative decisions in numerous countries (e.g. Germany, the U.S., Poland, Ireland).
o The decision to interrupt pregnancy is lastly a matter of conscience, which - more or less consciously - touches upon the fundamental ethical-cultural attitudes of pregnant women and society.
Product responsibility
A company that were to disregard these three special reasons when introducing a sensitive product would not do justice to its circumspection of and responsibility towards its own economic commitments, the legal framework of the state and the moral-cultural attitudes of society. Furthermore, HOECHST and Roussel Uclaf cannot allow themselves to be influenced by individual people or groups who do not view the reasons given as components of a complex and integral relationship.
Principles
HOECHST and Roussel Uclaf have therefore jointly laid down the following company policy on the use of mifepristone (in conjunction with prostaglandin):
Principle no. 1:
o The registration of mifepristone for the drug-induced termination of pregnancy can only be applied for in countries that have a definitive statutory ruling on abortion and where pregnancy termination is tolerated by society.
Principle no. 2:
o The country in question must have an advanced medical infrastructure. This must include the availability of prostaglandin and strictly controlled distribution and use of mifepristone.
Principle no. 3:
o There must be an actual wish for the licensing of mifepristone from a representative competent body of a particular country.
First company-policy principle
Two preconditions: Statutory ruling and societal consensus
The first company-policy principle contains both of the most important preconditions for the licensing of mifepristone in a country:
- a definitive statutory ruling on abortion and
- a societal consensus concerning pregnancy termination.
Inherent relationship of both preconditions
The lively public discussions, whether about the reform of Article 218 in Germany, the U.S. Supreme Court decision or the case of the young girl in Ireland who was raped, make it clear that both aspects are closely connected to each other. Even if a statutory ruling on abortion has been made in accordance with democratic principles, that ruling will not stand on firm ground if there is no societal consensus on dealing with pregnancy termination. The ongoing clashes in the U.S. even after the Supreme Court ruling, the continued polarized debate in Germany after the Bundestag decision, as wall as the move to the Federal Constitutional Court in Karlsruhe, Germany are evidence of this.
Statutory rulings
Summary of global statistics
It would now be useful to present a general summary of international statutory rulings. An evaluation of 144 countries shows the following picture.
- About one billion people (roughly 20% of the world's population) live in 49 countries where pregnancy can be terminated only if the mother's life is in danger (e.g. Islamic countries, Latin America, Africa) or where abortion is illegal under any circumstances (Ireland).
- About 600 million people (some 11% of the world's population) live in 47 countries where the termination of pregnancy is allowed if the mother's health is at risk, if the foetus has a malformation (embryo pathological indication) or if the pregnancy is the result of a criminal act.
- About 1.3 billion people (around 25% of the total) live in 23 countries where pregnancies can also be terminated for social and economic reasons.
- About 2 billion people (roughly 39% of the total) live in countries where pregnancies can be terminated on request during the first three months after conception.
- All told, 3.3 billion people (some 64% of the world's population) live in countries where pregnancies can also be terminated for social and or economic reasons.
- According to estimates by the World Health Organization, about 40-60 million pregnancies are terminated worldwide every year, of which up to 25 million are carried out illegally; approximately 200,000 women die of the consequences of (mainly illegal) abortions.
Limited use of statistics
Undoubtedly, this kind of an evaluation is not very powerful because it reveals very little about the actual motives and behaviour of those involved. There are for instance countries in which the medical indication is interpreted so widely that room is even found for the social indication, with grounds possibly being based on psychosomatic factors used to define health.
Apart from other reasons, the avoidance of illegal abortions with uncontrollable deaths of pregnant women in numerous countries has been the primary reason for decriminalizing and expanding the indications to the inclusion of abortion any time during the first three months.
Statutory rulings in Germany
In accordance with the unity treaty and until the enactment of a new law, unified Germany will temporarily (until the end of 1992) have two abortion laws: one permitting abortion for social or medical reasons in western Germany and the other legalizing abortion during the first three months of pregnancy in eastern Germany. The decisive factor is where the abortion takes place and not where the woman lives.
In view of HOECHST's first principle regarding the registration application for mifepristone, politicians often suggested that the company apply for the registration of mifepristone even before the Bundestag had reached its decision. The reason cited was the existence of a definitive statutory ruling on abortion.
Two important points were overlooked here. Firstly, by no means did the unity treaty approve the law of the former GDR but tolerated it at most. Secondly, a statutory ruling alone does not fulfill HOECHST's requirement of societal consensus, something that still does not exist today.
Societal consensus
Had Roussel Uclaf applied for a license in these circumstances, this would have merely intensified the polarization of the argument owing to previous experiences instead of promoting a discussion aimed at a consensus.
Consensus without ethical behavioural norms - impossible
This is primarily because the two sides of the public debate hold very different views about the advantages and drawbacks of mifepristone. For example, while one side is pleased that mifepristone turns abortion into a workaday occurrence from the medical point of view, the other deplores this same aspect on the grounds that it is yet another step taken against the protection of life and that it thus trivializes the termination of pregnancy.
The same facts are interpreted so differently because the current legal position is not perceived in the same way by people holding basically different ethical views. Nationwide consensus can therefore only be reached at the level of the ethical-cultural issue involved. This proves that laws do not merely hold because they are laws. Very different norms can be incorporated into positive law and then declared binding. Contentious principles of positive law can therefore be clarified and made known to the public only if basic ethical and cultural foundations are included in the deliberations. The current public debate on the termination of pregnancy indicates the difficulties involved in weighing up laws and morals and still bears the traits of an irreconcilable conflict.
Deficiencies in societal debate [sic]
Societal debate through differentiation
A clear symptom of the disastrous state of societal debate is the continuous changing and blurring of the discussion levels.
There are three levels in every society and every social system that are responsible for the development of the particular system:
o the normative level
o the organizational control level
o the operative level which must meet the needs and objectives of the system.
Consequently, every country has a cultural system, a political system and a supply system, which in the broadest sense can be called an economy.
Autonomy and interdependence of the systems
On the one hand, the so-called subsystems of a society, namely culture, political organization and economy, each have their own specific structures and output potential while on the other hand they are highly interdependent.
Autonomy of culture, politics and economy
In the context of the abortion debate (medical as well as surgical), this means the following:
o the cultural system in the broadest sense (churches, education, culture, art and the media) is concerned with the empirical and normative questions of pregnancy termination with the aim of developing acceptable behavioural norms and promulgating these throughout society.
o the political system of the state provides for the appropriate legal framework conditions for the adherence to behavioural norms. It ultimately aims at the stepwise elimination of deficiencies in the subjective outlook towards and objective aspects of pregnancy termination, yet seeks to stop negative developments immediately.
o the supply system (the economy including all commercial and non-profit manufacturing and service organizations) must meet needs of the society for products and services that conform to the existing legal and cultural framework conditions applicable to pregnancy termination.
Mutual dependencies of culture, politics and the economy
At the same time however, there are additional ties, dependencies and responsibilities that exist between the three subsystems of society, i.e. culture, the state and the economy, which must also be considered in the abortion debate.
o The cultural system relies on the state for its existence guarantee as well as on the non-material and material output of the economy in order to give adequate meaning to its constituent elements
o The ideologically neutral democratic state can only perform its function of maintaining order within the context of prevailing moral values and acceptable behavioural norms - thus, it is dependent on the actual output of the cultural system. By the same token, the democratic state is also dependent on the prosperity of the economy in order to fulfill its function of maintaining order.
o And finally, the economy needs sensible and beneficial national policy conditions as well as a viable cultural system because employees, customers and their motivations are its often neglected resources.
Polarization in the absence of differentiation ability
These explanations make it clear how easy it is for conflicts and polarized situations to arise when the autonomy of culture, politics and economy and their mutual dependencies are mixed together, for example when traditional and basic moral- cultural convictions are no longer accepted by large numbers in society but the political and economic system must continue to function. Societal debate inevitably suffers under the tension between the social subsystems, as we are experiencing in the abortion debate and particularly as regards the drug-induced termination of pregnancy with mifepristone.
New laws, whether Article 218 et seq in the Federal Republic of Germany or the Supreme Court decision in the U.S. are therefore a necessary but not the only precondition for the introduction of mifepristone by Roussel Uclaf. A publicly recognizable societal consensus, and thus one also recognizable to HOECHST, is an indispensable requirement, one that is also stated in the first principle of company policy.
Second company-policy principle
As regards the second company-policy principle concerning the use of mifepristone in connection with a prostaglandin, we'd like to say the following:
Preventing misuse:
With a preparation as sensitive as mifepristone, the legal standpoint must not only address the medical and psychological benefits, but also guarantee the exclusion of illegal and/or improper use. Both forms of misuse can be avoided if a country has a developed medical infrastructure and regulations stipulating distribution, administration and control as found in France and Great Britain.
Third company-policy principle
Responsibility throughout society
The third company-policy principle, which emphasizes the registration application for mifepristone only when expressly desired by a representative body of a country, becomes understandable in light of the complex and existential social problems of pregnancy termination. HOECHST and Roussel Uclaf can indeed be held accountable in product liability matters, but social responsibility is something that is shared.
Status in France, the U.K. and Sweden
For HOECHST and Roussel Uclaf, the three requirements of our company policy have teen fulfilled in France, the U.K. and Sweden.
Roussel Uclaf applied to the Department of Health for a license for mifepristone in the U.K. at the request of the Royal College of Obstetricians and Gynecologists. Mifepristone was licensed in the U.R. in July, 1991 and has been in use only in special centers as in France.
In Sweden, the registration of mifepristone was applied for in December, 1991.
Concluding remarks
Some fundamental considerations in conclusion of this information:
Complexity of cultural and religious traditions
The fact that millions of abortions have been carried out throughout the history of mankind continually shakes the very foundations of our self-perception. All religions, cultures and social orders have given the problem serious thought one way or another, and their different concepts of man and of the world have led to different judgments and behavioural norms, which are reflected in the plurality of opinions and regulations we have today.
The concept of abortion calls for objectivity against the background of the overall complex structure of interrelationships between the wide variety of religious traditions, progress shaped by scientific and technical considerations and by ecological awareness and vast differences in living standards. Thus, a quarter of the world's population enjoys economic prosperity while in the rest of the world millions are dying from starvation and countless others live in abject poverty. Enlightened awareness of democratic rights stands side by side with widespread pre-democratic and unenlightened social structures.
An appeal to thinking in terms of complex relationships
There are no easy solutions here. Those who believe in them because they hold simplistic views of the world, possibly for fundamentalist reasons, are not behaving responsibly. Those wishing to claim credibility for themselves in the ethical and legal debate must respect the complexities of the aforementioned interacting factors - not just in terms of their historical dimension but also in terms of their interdisciplinary ramifications.
National and global responsibility
An advanced civilization upholds the indivisible right to life as much as it respects women and mothers and their moral decisions. In their unique symbiosis, both are however threatened today in equal measure by an existing materialistic, individualistic and hedonistic attitude towards life. In this situation, society is obliged to respect women and their decisions. And should a woman decide not to carry a child to term, outsiders should always assume the hopelessness and severity of the situation until the opposite is proven.
Social responsibility for life must prevail wherever human life and the dignity of human life are threatened. It is all too easy to allow local concerns to overshadow global challenges if we fail to escape from the traditional confinement of the here and now in our ethical orientation. This is where churches operating around the world are called upon as advocates of life.
There have been too many speeches but still too little has been said in the public abortion debate so far. This must change if society is to arrive at an agreement over and above the democratic vote of the majority.
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