The drug and its ethical boundaries
Gonzalo Herranz
department of Bioethics, University of Navarra
XI Course of update for Pharmacy Postgraduates:
Advances in the development and research of New Drugs
School of Pharmacy, University of Navarra, September 18, 1996
I. Respect for people, the ethical frontier of medicine
II. The ethical frontier of Education-information
III. An Internal Frontier: The Marginalization of Women
IV. The ethical-economic frontier
V. The ethical boundary between medicine and poison
I suspect that my intervention this morning may be a discordant grade amidst the general, affirmative and hopeful tone of the Course. The idea of frontier is usually assimilated to those of barrier and boundary, police control or territorial conflicts. But, in the biological sciences, we are very used to use it to designate the Structures of intercommunication, of orderly exchange , of maintenance of gradients on which life itself depends.
The frontiers of medicine are vast. It is enough to take a few moments to make a list of them to immediately recognize that they are many and of very varied conditions. And, what interests me most, quite a few of these frontiers have, to a greater or lesser extent Degree, an ethical element: I suppose it is precisely about them that the organizers of the course have invited me to speak. I think, therefore, that my intervention should be entitled degree scroll The drug and its ethical frontiers.
And, in considering them, it becomes clear once again that the ethical frontiers of medicine are so many and so complex that one hour is insufficient to deal with them: an entire course at update would have to be devoted to them. I will therefore refer to only a few of them. I will leave aside some as interesting as the ethical aspects of the new frontier, agreed last November by the European Community, the United States and Japan, to simplify the preclinical phase of the essay of new drugs. Although these may appear to be new regulatory or administrative control rules, the decisions taken are, at bottom, ethical in their foundations and objectives. They are guided by the compassionate and beneficent motive of speeding up the financial aid to the sick, by the duty of justice of not placing superfluous obstacles in the way of the approval process for new drugs. Reducing by 30% the duration of stability testing of pharmaceutical products, or simplifying the programs of study of toxicity, with the consequent saving of time, animals and money, are ethical actions of high value, and not only wise measures of efficient management . Limited time forces me to leave aside issues of subject of the ethical limits indicated by the new E.C. Directives on advertising of medicinal products for human use, loaded with legal considerations of harmonization, but also with ethical purposes that try to favor the good use and consumption of medicines. It would be very interesting, almost urgent, to specify these limits, since today advertising promotion is not only related to drugs that we call advertising, but in some advanced countries it already affects drugs that can only be dispensed with a prescription. There are boundaries in the clinical use of drugs that I cannot deal with and that we can leave for discussion: for example, that which separates the good use from the bad use of placebos, not in the pharmacological-clinical research , but in the ordinary therapeutic relationship, an issue on which there are notable divergences in the Codes of Medical Ethics. Logically, the drug also has tortuous ethical boundaries in its economic and social aspects. For the sake of argument, and I apologize for the tongue twister, there is an ethical boundary to the ethics of pharmaceuticals, since ethics can be abused or used in an unethical manner.
I have chosen, in order to present them in general terms, a few ethical boundaries of the drug that seem interesting to me: the fundamental limit that is respect for the person; the line to which the pharmacist's function of Education-information must extend; the boundary of the marginalization of women in the enjoyment of drugs; the professional limits of the drug as a commercial product; and, finally, the boundary that must separate the drug from the poison. In conclusion, I would like to add a few words in favor of the Codes of Ethics and Professional Conduct, which are, in my opinion, the best maps of ethical boundaries available to us.
I. Respect for people, the ethical frontier of medicine
Respect for persons is the fundamental ethical attitude of professional ethics. In the health professions, this principle is particularly relevant in the field of biomedical research , but it is also essential for the relationship of professionals with individuals. I will immediately deal with respect for the individual as a limit of the research in clinical pharmacology. In the following section, I will discuss the pharmacist's educational role as a manifestation of respect.
This principle of respect for persons was the first to be formulated in the history of modern biomedical research regulation. The Nuremberg Code pointed out once and for all that science, not even good science, is not enough to guarantee the moral rectitude of research. Before and after Sociobiology, one thing is clear: that natural science alone is incapable of solving the ethical equation: science and research must submit to the universal rule of respect for man.
It seems to me that this topic, among us, has not been understood in all its significance. We are not aware of it. It is good, therefore, to treat it with a little energy. And for that, there is nothing better than going back to the sources, so as not to act on hearsay, or second-hand, or with faded and colorless memories. I recommend to my students at doctorate, to those who are going to work in clinical pharmacology in particular, that every year they meditate and comment among themselves on the serious words of the first rule of the Nuremberg Code:
"The voluntary consent of human subjects is absolutely essential. This means that the person concerned must have legal capacity to consent; must be at status such that he or she can exercise full freedom of choice, unimpeded by force, fraud, deceit, intimidation, promise, or any other form of coercion or threat; and must have sufficient information and knowledge of the elements of the experiment so that he or she can make an informed decision. This last element requires that, before accepting an affirmative response from an experimental subject, the researcher must have made known to him/her the nature, duration and purpose of the experiment; the methods and means by which it will be conducted; the inconveniences and risks that may reasonably be expected; and the effects on his/her health or personality that might result from his/her participation in the experiment.
The duty and responsibility to assess the quality of consent rests on the shoulders of every individual who initiates, directs or collaborates in the experiment. It is an obligation staff that cannot be delegated with impunity to another."
These are strong and demanding words. It has been said that this first rule of the Nuremberg Code is impossible to comply with in many experimental situations that are considered ethically acceptable. But it seems convenient to me that, in a document that lists principles, not regulatory standards, it is better to overdo than to underdo. Routine wears away the sharp edges of the rules, but the firmness of the formulas is necessary to constantly put things back on track. The basic doctrine is valid. The Declaration of Helsinki translates, in less emphatic language, the same spirit in its Basic Principle 9: "In any research on human subjects, the first thing is to inform all potential subjects adequately of the aims, methods, expected benefits and possible risks of the study and of any discomfort that may be involved. They should also be informed that they are free to participate or not in the experiment and to withdraw their consent at any time. The physician shall then obtain from the subject, and preferably in writing, his freely given informed consent."
Do we sincerely respect this frontier, which is a moral line that we should never cross? Judging by what is published, respect for the person of the experimental subject does not seem to be fully in force among us. In the works on clinical research (including many on clinical pharmacology) published in our most prestigious journals, there is still the curious phenomenon that the intervention of the Ethics committee of research in the approval and control of the experimental protocol is rarely mentioned. The criteria for inclusion and exclusion of experimental subjects and many other methodological details are sometimes described in detail, which is very commendable. But virtually never is there any mention of how informed consent is obtained, as if that element of the experimental procedure were of no interest or intrinsically incapable of innovation or adaptation to specific situations. I do not doubt that the rule management assistant is complied with and that patients and healthy volunteers sign the form consent form offered to them. My doubts concern whether the delicate and humane process of obtaining free and informed consent has all the ethical intensity that respect for persons demands; or whether, on the contrary and in the case of patients, it is a substitute for it, routine, collectivized, diluted in the rest of medical care.
Is this silence of the publications due to a simple oversight at the time of writing the article? It does not seem likely. The good researcher does not omit in the description of his methods or his observations any part of his work which, besides being essential in the process researcher, has occupied him considerable time and demanded considerable effort. The manner in which consent was obtained cannot be regarded as unimportant. Failure to mention it in the published articles is probably due to the fact that it has not been given due attention or has been omitted. And this is not only the case at the stage of work: it is also the case at the stage of its assessment publishing house . I take it for granted that every member of the committee publishing house of a biomedical or pharmaceutical journal, and every expert capable of evaluating research papers, and many of the readers of these journals, are familiar with the Declaration of Helsinki. Its Basic Principle 8 reads as follows: "In publishing the results of his research, the author is obliged to ensure the accuracy of his results. agreement Articles from research that are not in accordance with the principles outlined in this Declaration should not be accepted for publication". For its part, the committee International Association of Medical Journal Editors (the so-called group of Vancouver) has included, among the requirements of uniformity for originals submitted to biomedical journals, the following rule: "When reporting on experiments on human subjects, it should be stated whether the protocols applied have followed the ethical standards of the committee of research Clinical of the institution where they were performed or the guidelines of the Declaration of Helsinki". Without this requirement, no work should be accepted for publication. And yet, the journals that have subscribed to the requirements of uniformity routinely neglect this commitment. Moreover, Law 25/1990 on Medicines, in its article 69.1 establishes that "The publication of authorized clinical trials will be carried out in scientific journals and with accredited specialization of the committee Ethics that informed them", words that are reproduced literally in the draft of the future Royal Decree establishing the requirements for the conduct of clinical trials. For the moment, more than half of the papers by Spanish authors omit any reference letter on this issue.
It is to be hoped that in the future we will pay more attention to procedure to obtain informed consent and to its accredited specialization, and eventual description, in published studies. What is important, in the end, is not so much to comply with legal norms or those of procedure publishing house , but to practice the ethical principle of respect for persons; that all researchers be imbued with the idea that, in the research on man, the interests of science and society (and much less those of researcher, their lack of time, their conviction of the potential value of the essay they perform, their determination to enrich their curriculum of publications) should never take precedence over the interests of the person. Hopefully, by a happily synergistic effect of ethics and law, many biomedical researchers will overcome the mentality, psychologically fixed in adolescence, that only hard science matters; hopefully they will become open to the ethical, and not just the administrative, imperatives of research, namely, that researcher and subject are moral persons who, persuaded of the value of science, respond freely (and almost always affirmatively) to fulfill the general duty to do research and to volunteer to be the subject of research. In my opinion, part of the work and vocation of the researcher is the task of being an educator, an explainer, and not only an experimenter. The research should exert, through the internship of respect for people, a humanizing effect on doctor-patient relations and on the general hospital environment. It is necessary that the slightest trace of inhuman guinea pigism disappears from our care institutions. This is a frontier we must reach. A pharmacist is part of the Clinical Trial Ethics Committees: his role cannot be reduced to the control and dispensation of the experimental product. His responsibility in the committee is full, indivisible.
II. The ethical frontier of Education-information
Most pharmacists are not involved in the ethics of research, but they have countless opportunities to exercise their respect for people. I believe that the good pharmacist is excited to think of his or her pharmacy not as a purely commercial establishment, but as a social cell in which health education takes place, as a school for the rational use of medicines. The function, and not only the degree scroll, that modern societies grant to the pharmacist, of expert in the medicine has in that educating and informative mission statement one of its most genuine expressions. Being an educator is also a legal obligation of the pharmacist: the Medicines Law assigns this duty and specifies its general contents in article 87. It states, among other things, that in order to achieve the goal of procuring the rational use of medicines in primary care, the pharmacist must carry out the following educational actions:
c) Inform patients about medication (...).
e) Promote, and participate in, the Education of the population on medicines, their rational employment and the prevention of their abuse.
g) Inform, advise and instruct patients on the correct use of the medicines he/she dispenses, with full professional responsibility and agreement with the prescription, or according to the guidelines of pharmaceutical science and art in the case of those authorized without prescription.
The pharmacist has here a professional task of social and health high performing . If, as seems likely, the tendency to include more and more products in the list of over-the-counter drugs that are increasingly potent and active, but also more susceptible to undesirable reactions and drug-drug interactions, persists and becomes established, the field of the pharmacist's educational responsibility will expand at the same time.
Today it is often repeated that the dispensing of a drug consists of the submission of a product and, together with it and inseparably, the transmission of information. No matter how much is gained by improving the text of package leaflets for user information, face-to-face communication between the pharmacist and the patient will always be essential; moreover, it will be increasingly necessary. This poses a new frontier for the pharmacist. Although this communication should never invade the physician's own territory, it requires a much more explicit and evolved level of the physician-pharmacist relationship. In this relationship, the expressions of professional respect and reciprocal staff , of frequent mutual enquiry , of development of generic and therapeutic substitution criteria, and of cooperation in the fulfillment of the common goal of providing the best service to the patient should be refined. The task of educating and informing will demand a lot of time and patience from the pharmacist. And although most of the time it will be sufficient to give technical information, sometimes it will have to deal with personal and sensitive issues, so that, in order to maintain secrecy and respect the right to privacy, it will be inappropriate to have them from one side of the counter to the other, in the presence of other customers. Such information ethically requires the more private environment of the pharmacy owner's office or reticule.
The information owed to patients requires a certain requirements. The pharmaceutical profession is, above all, an intellectual activity that requires a high level of knowledge that can only be acquired through a university degree Education , maintained through continuous study and Education throughout professional life. The pharmacist's vocation is one of service and committee, which cannot be routinely limited to submit medicines in exchange for their price. His function is not only to supply the public with medicines that may be prescribed by the physician or that the pharmacist himself may advise: he must go ahead and give the appropriate warnings and advice whenever the health or the interest of the patient or customer so requires.
The pharmacist is obliged to provide accurate and up-to-date information. His recommendations must be responsible and balanced, based on data that he can adduce on the current state of science and the pharmaceutical art of the moment. They should, among other things, make reference letter to the possible side effects of drugs, to possible interactions, and to the measures to be taken to prevent or treat them. Pharmacists and their assistants should always bear in mind that advertised drugs are not simply commercial products that the customer buys at will. On many occasions, they should remind the customer of the limitations of use in children or in specific patients, their possible interferences and contraindications, and the limits of their consumption. Sometimes, and for solid reasons, the pharmacist will have to advise the customer against the purchase of a drug or health product, recommend the suspension or substitution of a drug that the patient is receiving, and will have to discuss these points with the physician or advise the patient to do so himself.
The information provided by the pharmacist must have a solid scientific basis. Information from reliable and independent sources is, in principle, preferable to that from advertising materials. The pharmacist, like the physician, must critically evaluate the information he/she uses to advise his/her customers. It should not be forgotten that advertising materials differ from non-advertising scientific information in some important aspects: they tend to encourage unjustified consumption, they deal only partially with side effects, they do not objectively evaluate other therapeutic alternatives, and they tend to exaggerate the efficiency of their own products.
Some of these considerations may seem to be simple platitudes or moralizing exhortations. I am convinced, however, that they are both valid and topical. The pharmacist's educational mission statement is the clearest distinguishing feature that distinguishes the pharmacy office from any other store dealing in noble matters. Moreover, in the very near future, the establishment of the free movement of people, services and goods that the single market will bring with it, obliges us to make the effort to gain the new frontier of pharmaceutical information and Education .
III. An Internal Frontier: The Marginalization of Women
A Galician song says that "the first love affairs are very bad to forget". The first time I participated in one of these courses at update I did it dealing with "Gestation and medications: ethical aspects". Since then, my interest in topic has not waned. I have followed it closely and have even had the opportunity to make recommendations to important pharmaceutical laboratories and some political figures. I am beginning to think that I have achieved something.
What Louis Lasagna said many years ago is still true: incredible as it may seem, women are therapeutic orphans. To prove it, it is enough to read the package inserts of drugs. It is common to find the clause, more legal than scientific, of exemption of responsibility: "There is no data about the effect of this drug on pregnancy. Women of childbearing age should abstain from taking it, especially during pregnancy (or its first trimester), or it can only be administered to them if they are using a highly reliable contraceptive method". Women of childbearing age are thus often faced with a dilemma: either pregnancy or medication. Let us note that this serious deprivation of liberty is based on ignorance of the reproductive toxicity of the drug in man, not on data positive evidence of such toxicity.
In clinical trials, and, in general, in the programs of study of research biomedical (leaving aside, of course, the areas of gynecology and obstetrics), women are either absent or poorly represented. Most of the data on human pharmacology have been obtained on men and refer to them, not women. This is so strongly rooted in the research internship that it causes paradoxical situations. In old age, when the reproductive toxicity of drugs can no longer be invoked as a limiting factor for research in women, women continue to be as marginalized as in their childbearing years. Coronary heart disease is the leading cause of death in women, but women have been excluded from trials to determine whether taking an aspirin a day reduces the issue of heart attacks. Women have a longer life expectancy than men, so that, in different age strata, the geriatric physician has to see, for every elderly man, two or three elderly women. And yet, in programs of study very important on the relationship between old age and health, there has been a marked tendency to exclude women. Things have reached an almost ridiculous extreme, in a pilot study, funded by the US National Institute of Health, which is part of a large project on the impact of obesity on the incidence of breast and uterine cancer, and which curiously has been done exclusively in males. It was a research about the effects of certain dietary factors on estrogen metabolism: the researchers chose males on the assumption that estrogen metabolism is similar in men and women.
This systematic exclusion of women from therapeutic benefit prompted me to intervene to change the guidelines of a series of clinical trials on an anti-HIV agent. Women were marginalized in the initial protocols, which is very difficult to justify ethically, since not only are women of childbearing age the population in which HIV infection is growing most rapidly: It is, in my opinion, an urgent matter to determine to what extent nucleotide analogues (in the specific case I am referring to, with a teratogenic or abortive effect practically nil in the preclinical programs of study , at doses tens of thousands of times higher than the therapeutic ones) have any protective effect on the vertical transmission of the disease, a problem of formidable human and public health dimension. The social tension over the growing issue of HIV-infected children cannot be resolved either with the cruelty of abortion or with late therapeutic treatment: it is necessary to prove whether and to what extent prenatal treatment, which, judging by the data available to us, does not have to be started until well into gestation, is a better remedy.
In fact, under the pretext of chivalry, of the biological instability created by the hormonal changes of the menstrual cycle, and, after the thalidomide tragedy, of the need to offer potential protection to women who could potentially become pregnant and their fetuses, fertile women, and for that matter, women of any age, have been left out of the pharmacological-clinical research . As Carol Levine points out, the exclusion of women is global, without nuances, and this is because in clinical pharmacology there is a tendency to think that all women are equal, that they are all sexually active, and that practically none of them can be trusted as subjects of research. And this happens when most clinical trials do not present foreseeable risks for the future child, or when the unknown and unpredictable teratogenic risk, which accompanies practically all physiological interventions, does not serve as an argument to justify the exclusion of women from these trials and their eventual therapeutic applications. Carol Levine goes so far as to suggest that women should be offered the opportunity to be included in programs of study that, even though they may present known risks to their offspring, have clear therapeutic advantages for those who participate in research. Given honest information about the particulars of the case, women could evaluate these risks and benefits, and make a rational choice about whether or not to participate in essay, as well as about their reproductive behavior during the course of the procedure. The possibility that some women might become pregnant and decide to go ahead with the pregnancy and have a child who would eventually be harmed by their exhibition to the experimental intervention would, in any case, be very small and in no way justifies the policy of systematic exclusion of fertile women or the imposition of forced contraception that many protocols currently call for. After all, it is more judicious and more scientific, in principle, to allow women who wish to run the risk of potential harm to their offspring and who refuse abortion to participate in the essay, waiving any compensation for the harm suffered, or even without waiving it, than to transfer, as is the common internship , for later and under the uncontrolled conditions of ordinary clinical therapeutics, the accumulation of anecdotal data on the teratogenicity of the tested product.
It seems that, fortunately, better times are beginning to dawn for the woman and for the pregnant woman. The future Royal Decree on clinical trials no longer contains the restrictive clauses of R.D. 944/1978 and the Order of August 3, 1982 that develops it, which are still in force. Contrast article 5.3 of the latter with paragraph 4 of article 13 of the future Royal Decree. The first one says: "Pregnant women, or potentially pregnant women in the period of research, cannot be included in the clinical essay except when the drug is supposed to have a beneficial action in the different conditions of this vital status . In any case, all essay in women in these conditions should be preceded by a clinical essay in other adult women, with careful programs of study of clinical pharmacology and hormonal and metabolic parameters that may influence gestation". It proposes the second: "In pregnant or breastfeeding women, non-therapeutic clinical trials can only be performed when the committee Ethics of research Clinical concludes that they do not pose any foreseeable risk to their health or to that of the fetus or child and that useful and relevant knowledge will be obtained on pregnancy and breastfeeding". It follows from this that, under the general conditions of the research, clinical trials for therapeutic purposes are lawful. And, in the field of facts and not only in the field of rights, the Director of the National Institutes of Health, Bernardine Healy, in order to repair the years of withdrawal of women's health problems, has made approve the project most economically substantial in the history of the NIH, which will focus on menopausal women's health issues (heart disease, osteoporosis, breast cancer, colon cancer).
Better times are ahead for this marginalized majority. It would be very interesting if pharmacies did not remain oblivious to this problem.
IV. The ethical-economic frontier
Last year, a large part of the activity of the Permanent committee of the Physicians of the European Community and its Ethics Subcommittee was devoted to studying the problems related to the harmonization of national drug regulatory systems. I am not interested now in referring to the conflicts of interest that pitted some countries against others, the large multinational drug companies against the small and medium-sized pharmaceutical companies of each country, pharmacists against consumer groups, and all against the national or community authorities. What interests me here is to extract from all this whirlwind of discussions, draft proposals and political decisions, a very interesting topic : the discussion, which is still open, about what is the ethical notion of a drug as an economic entity.
We have come a long way. Ethical considerations have contributed to the constant refinement of the rules governing the production and use of drugs. The upward thrust of drug laws-first toward clinical safety, then toward the need to demonstrate efficacy, now toward rational therapy-has come from a strong ethical commitment. I believe that, in our environment, progress has depended on the maturation of the institutions of the European Community. The European Community, which was founded for promote economic and political integration, has evolved over time so that it is no longer simply a market in which products, services and people can circulate more freely every day, but an increasingly integrated society. A society in which, among many other things, there are producers and consumers, but also patients and doctors, pharmacists and medicines. And in such a society we must often ask ourselves whether ethical criteria prevail over economic interests, whether human rights prevail over political opportunism, whether institutions are at the service of people.
The pharmaceutical industry and services are a very important item in the accounts of the European Economics . But medicines cannot be treated as mere consumer goods, which one buys because one wants to. People can be as original or as whimsical as they like when it comes to buying the many things that the stores are full of. One can act with great freedom, even capriciously, when buying a sound column or a pair of jeans: one can always ask one's friends, take advice from the salesperson and, in the end, choose what one likes best. But people are not ready to decide with which medicines to treat their illnesses. Even advertised medicines cannot be regarded as mere consumer goods, but must be given special consideration: determining which are the safest and most effective is in many cases too complex a matter for patients and, for that matter, general practitioners to decide. Everyone, patients and physicians alike, have no choice but to rely on the skill of the health authorities, which they assume are capable of removing inoperative, dangerous or unsafe pharmaceuticals from the market. If potentially dangerous medicines were available in pharmacies, people's confidence in them would collapse. Pharmacies, instead of being offices at the service of health, would become a public health hazard. The same would happen, although to a lesser extent Degree, if it were known that pharmacies sold useless products.
Therefore, a pharmacy cannot be a store, nor should the pharmaceutical industry be based on purely free market premises, where the rule of caveat emptor prevails. I have already said that a pharmacy office receives its peculiar dignity from the fact that it dispenses medicines and information together. If the pharmacist is to consolidate his social role as an expert in medicines, he must not abandon his educational function, his commitment to not deceive anyone, to critically and scientifically evaluate the curative power or the health value of the products he dispenses. Ethical and scientific values must always prevail over economic interests.
V. The ethical boundary between medicine and poison
The relationship between drug and poison, between medicine and poison, is very complex and varied, a relationship that is knotted in the very origin of the words. On the one hand, it has been a permanent part of the medical and pharmaceutical deontological tradition to respect the inner boundary, sometimes very tenuous, that separates the therapeutic dose from the toxic dose. This respect has always led to the search for drugs with a wider therapeutic margin and safer handling. The primum non nocere, the ethical principle of non-maleficence, shared by physicians and pharmacists, has been a constant and effective stimulus for the research and development of new families of molecules and new administration patterns.
But I am not interested here in referring to that intrinsic risk feature that every drug possesses of revealing itself as a potentially harmful agent. I prefer to refer to other ethical problems, which, although they seem distant from us in space and time, involve us much more intensely than might appear to be the case. Because the world today is a small world, and the future is now arriving much more quickly. The first problem, the one that seems to refer to remote lands, is this: are there ethical limits to the marketing of substandard drugs? The other, the one that seems far away in time, is this: can cursed drugs, designed to damage health or life, combinations of drugs for personality manipulation, ecstasy of pleasure, athletic performance enhancement, enter our formularies, in the lists of essential medicines? Will the legal recognition of the autonomy of individuals one day make legally tolerable the design, research, marketing and even pharmacovigilance of drugs intended for suicide or euthanasia?
Let's start with the simplest topic : the marketing of drugs of leave quality. In the third world, obsolete drugs are marketed and discarded as dangerous or inefficient in advanced countries. In the latter, serious frauds have been described with generics. From time to time, we read in the columns of the Lancet magazine news and comments on the double standards of some large pharmaceutical companies, which, while in the advanced West, scrupulously comply with the norms of good internship, follow a condemnable, discriminatory conduct in Third World countries. Criticism comes not only from associations of physicians, pharmacists and consumers in poor countries. The International Federation of the Pharmaceutical Industry itself published, in 1989, a brochure graduate Poverty, Sickness and Medicines. A Unholy Alliance. Its author, Klaus M. Leisinger, reviews some "scandalous examples of corporate misconduct" among companies doing business in underdeveloped countries. The author tells us how certain multinationals, as well as some small local companies, are terribly reluctant to change their policy of exploiting poverty and ignorance. Bleeding anecdotes are known in India, in sub-Saharan Africa, in some Latin American countries: marketing of expired drugs from advanced countries, dispensation for human use of veterinary drugs, sale as vitamins of low-priced drugs presented in attractive colored capsules. There are countries where highly dangerous and irrational combinations, or products that were removed from the authorized lists years ago, are still being dispensed.
Health professionals have subscribed to the principle of non-discrimination among patients on the basis of skin color, religion, political convictions or social status. In order to be faithful to their moral promises, they have sometimes gone so far as to declare a boycott of certain pharmaceutical companies, and have been joined by consumer associations, foundations of research and environmental groups. But result has not always been brilliant: these companies often succeed, thanks to their political influence, in overriding the doctors' protests; their lawyers are well aware of all the legal subterfuges to defer court decisions and plan a very slow recall of the condemned products, or to initiate criminal defamation suits against their detractors. purpose It is instructive to see how in countries on the way to development civil resistance is resorted to with the aim of not blurring the line that should always exist between medicine and poison. So far, these protests have had little echo among us. Pharmaceutical firms exert very strong pressures, through the paid advertising , on biomedical and pharmaceutical journals, which cannot do without this source source of income. Leisinger speaks of the possibility that, if the companies do not end up assuming their ethical commitments and responsibilities, a worldwide boycott should be declared against them. The solidarity of physicians and pharmacists with their colleagues in advanced countries could result in tremendous economic losses for these recalcitrant pharmaceutical companies.
The other ethical problem of the borderline between medicine and poison, the one that seems far away in time, refers to the ethical neutralization and eventual legalization of cursed medicines. The issue seems far away, but the process of blurring this border has already begun in some sectors. The knowledge dissemination among the public of the pharmacology of suicide is no longer the exclusive concern of euthanasia activists and the books they write, such as, for example, "Final Exit", by Derek Humphry, or "Suicide. Do it yourself", by the Dutch Death with Dignity group . The Dutch National Health committee has published in the general press a list of lethal doses of the drugs that can most advantageously be used for suicide. In Spain we should turn on an alarm light. The project of the New Penal Code, which the Spanish Government has just sent to the committee of State and the Judiciary, includes in its article 147.4 a new crime, of homicide by disease, which does not necessarily have to be carried out by the physician or under his direction, and which is punishable with very light penalties. At internship, decriminalization can be reached quickly. In the dynamics of legal tolerance, the homicide of the sick begins by signifying that killing without pain is an exceptional way of treating certain diseases, justifiable only in extreme, dramatic situations. But, inexorably, as a result of social habituation and judicial indulgence, one ends up admitting that killing for compassion is an acceptable therapeutic alternative, and in fact so effective, that a sensitive person cannot morally condemn it. The reason is obvious: euthanasia is a painless, compassionate, clean, quick, one hundred percent efficient intervention, and much more comfortable, esthetic and economical than the best palliative treatment. Consequently, it tends to become the supreme solution for certain patients or for the relatives of certain patients.
If the legal and parliamentary discussion of this project does not prevent the promulgation of this article in its current text, we can only wait and see how the demand for drugs for the scientific provocation of painless death develops among us. Will poisons-medicines to induce death be included in the list of registered drugs? Will they be included among those of compulsory dispensation?
Years ago, no one could have imagined that abortifacient drugs could be dispensed in a pharmacy. Today, mifepristone is dispensed in Orthogenesis Centers in France and in hospitals in Great Britain and Austria (soon, it seems, in those of the Scandinavian countries). Before going any further, I would like to point out that I am not opposed to the non-abortifacient use of this molecule. On the contrary, I would like it to be very effective in the treatment of many diseases, so that it would produce economic benefits without the need to resort to its abortifacient uses. The firm ethical rejection of its employment as an inducer of embryofetal death should not interfere with the development of clinical trials to determine its merits in the treatment of gynecological, endocrine, neoplastic, ophthalmological or any other diseases, and its controlled dispensation.
I would like to comment briefly on the ethically surprising fact that, in these countries, mifepristone is only dispensed in hospital pharmacies. I am saddened that it is precisely hospital pharmacies that have to dispense RU-486. Hospital pharmacies play a role of model for the rest of the profession, as they are the privileged place where many new professional interventions are created, developed and tested, and where many students and young pharmacists do their first internships. It is a shame to see that they can be taught there that dispensing for life or death are two equally legitimate aspects of their future professional activity; that the pharmacist can divorce his or her technical skill from his or her moral commitment to serve life; that, in the end, technique can prevail over ethics.
Something similar happens on the borderline between the legitimate treatment of minor ailments and what has been called psychopharmacological hedonism. The idea of health as a state of perfect well-being is leading many human beings to the abusive consumption of drugs. People are convinced that it is a right not only to get rid of all discomfort, even the slightest, but also to stimulate or calm their emotions thanks to psychotropic drugs. For many people, the Chemistry is replacing the ascetic effort as a means to overcome the limitations of character or the difficulties of life. When one hears about the enormous consumption of psychotropic drugs, one cannot help but think of how the threshold of tolerance to suffering has dropped in recent years. The pharmacist has a great responsibility in this field, as well as in the containment of the phenomenon of doping, contraceptive abuse, manipulation of moods, and the knowledge dissemination of fictitious forms of therapeutics. Alternative medicines have their own pharmacopoeia that often exploits the credulity of part of the public. I believe that there is a moral boundary that prevents the pharmacist from collaborating with these marginal forms of treating disease.
In order to prepare some points of my speech this morning, I had to consult some documents on pharmaceutical ethics, especially from the Anglo-Saxon area , namely the 1984 Code of Ethics, promulgated by the committee of the Pharmaceutical Society of Great Britain, and its invaluable Guidance Notes; the 1969 Code of Ethics of the association American Pharmaceutical Society, with its Annotations. I cannot hide my admiration for them, particularly for their moral wisdom and for the prudent firmness with which they are applied at internship . From my experience in the field of medical deontology, I observe, on the contrary, that the Codes of Ethics and Professional Deontology have a quite different fate among us. They are made into very careful and modern drafts, are subjected to a process of dilution of many of their rules in the institutional approval process, are promulgated without hardly advertising, and immediately enter into a resting phase, from which they occasionally emerge when their rules are to be used for political purposes. They function more as a defensive weapon to be wielded only in situations that threaten the institution from outside, than as a moral nervous system for the practice of the profession.
I would like to conclude by expressing my opinion that a profession that lacks a Code of Ethics is an incomplete profession. The lack of ethical regulation of the pharmaceutical profession in Spain is an anomaly B . Fortunately, we have increasingly better legislation. Even, from a technical point of view, it can be said that the most recent one is of a high quality Degree . But the ethical boundary of the drug remains to be drawn, a boundary that by its very nature must have finer pores, more sensitive mechanisms to establish a more demanding professional conduct than the pores and mechanisms imposed by the laws. The International Pharmacy association , in 1989, after much reflection, offered guidelines for codes of ethics for pharmacists, approved at the Sydney Assembly in September 1988, to serve as an inspiration for national codes guide . The European Community Pharmaceutical Grouping, in its White Paper of June 1990, recommends that national associations of pharmacists promulgate National Codes of Ethics in order to compile in them those professional duties which, although they do not appear in their respective legislation, are part of the professional ethics of pharmacy. The same White Paper also includes the Charter of European Pharmacy, with the principles that are to be the basis for the present and future practice of the profession within the European Community. The Charter concludes with a commitment by pharmacists to "assume their professional obligations in order to maintain the ethics and independence of pharmacy at all times".
This is the frontier of medicine that must be set: the one that guarantees, together with ethics, independence. The price of this is the serious commitment, assumed before society, to comply with the ethical standards formulated in a serious, modern, demanding code of professional conduct of excellence, known by professionals and by the public, which, above and beyond strict compliance with legislation, indicates the moral obligations and technical competencies that the pharmacist owes to society, to his colleagues, to other health professions, to the health authorities, and defines the ethical levels of his relations with social insurance agencies and his functions as agents of community health. To say today that there is no need for ethical-professional boundaries for medicine, that legal limits are sufficient, means one of two things: either to consider that the public can be treated with the minimalist ethics usually required by law, or to dangerously ignore the fact that legislation alone makes professionals easy toys for political power. This is the challenge to which Spanish Pharmacy must respond, the new frontier it must consolidate.