- Email: [email protected]
Ethical problems in psychopharmacological research
Prog.
Newo-Peychophazmacot.
Vo1.3,
pp.287-291,
1979.
Press Ltd.
Pergamon
RI’HICAL PROBLEMS IN PSYCEOPHARMAcoLOGIcAL C. GENTILI Istituto
Printed
in Great
Britain
RESEARCH
and G. PPXRARI
di Psichiatria "P. Universita di BO~Q~IUI,
Ottonello", Italia
Contents 1. 2. 2.1. 2.2. 3. 4. 5.
Abstract Introduction Medical ethics and psychopharmacological research Preclinical phase Clinical phase The consent in human therapeutical and non-therapeutical Relationship between science and technology Control and regulations in drug trials References
287 287 288 288 288 288 289 290 291
trials
Abstract I. 2. 3. 4.
Key
Scientific research poses considerable ethical problems which in human psychopharmacological studies are frequently faced by singling out consent as the only reliable source of human respect, although it is never free, spontaneous, or informed. On the other hand, various ethical problems present in the "life" of a new substance in the case of industry and preclinical, clinical and mass experiments, are left behind. Thus there arise justified protests which go so far as disowning science and technology. use of them must be prevented. To criticize science and technology is of no use: incorrect Such a guarantee can only come from an international control committee, capable of coping with a multinational power such as industry, supported by peripheral elective coassittees, which grant the citizens a direct participation in the administration of health. words:
consent in pharmacological research, control relationship between science and technology,
1. The adjective we are already some difficulty
in drug trials, human respect
ethics and drug
in research, trials.
Introduction
"ethical", included in the title, acquainted with the subject (Gentili in sketching out our presentation.
brings out an uncertainty et at., 1972; Gentili,
which, although 1974), has raised
Ethical concerns a whole series of concepts such as science, technology, progress, right, so as to arrive at a logical and coherent which oblige to precise and clear definitions, argument. This already appears to us a necessary attempt in order to proceed to the description in an ethical manner. In fact ethical concerns not only the formulation and the description of the phenomenon, but also the methodology, the steps and instrlnnents needed for the correct comprehension and solution to the problems which the phenomenon itself poses. So ethical means correct or good.
C.
288
This adjective, praxis requires and on the other
As
Medical
Ethics
experimental research above all in a general problems are met with in the various clinical and the human or clinical. upon them as they are fragmentary the global ethical problem which 2.1.
far
as
but
Preclinical
and
G.
Ferrari
when applied which pertains to moral philosophy, a coherence which on the one hand will fulfil each will impose sound judgement to each and every side
2.
stage,
Gentili
and
Psychopharmacological
to an ideology aspect and time of them.
or to a of them
Research
ethical problems appear constantly at every is concerned, So, in psychopharmacological research such formulation. moments of its two fixed stages, the pre-human or preThough they are important, we do not intend to dwell and we could say surpassed in as much as they are part of is at the basis of the entire research.
phase
Therefore we shall limit ourselves to remember how, in the first pre-human or pre-clinical phase, we begin by searching for new active principles and by singling out and choosing subThere follows an attempt to collect the data and to come to a reastances for experiment. soned conclusion on the tests carried out on the animal in order to apply the substances for clinical use. Usually this stage is carried out by the pharmacological industry which is bound to market and profit laws and therefore acts differently from the ethical model. The the different attempt on correct work at such a level is constant also for other reasons: effects of drugs on animal species, the determination of the efficacious dose, the methodological choice of the biochemical and behavioural parameters to be used, and the appraisal of their predictable value. 2.2.
Clinical
phase
The transition to clinical experiments, that is to say, to man (in its various stages: pharmacodynamics. therapeutical experiments, planned experiments, generalized therapeutical experiments and, finally, the study of the long-term effects of a drug) involves further obstacles to be overcome in order to proceed correctly, i.e. the difficulty in singling out the somatophysiological and psychological parameters which have to be considered in order to obtain reliable responses firstly in the healthy human being and later in the patient.
3,
The
Consent
in
Human
Therapeutical
and
Non-Therapeutical
Trials
At this point the respect for the person takes first place, respect that has received acknowledgement with the Nuremberg Decalogue and with the Helsinki Charter, which we are all acquainted with. These documents have emphasized the importance of the consent both for the experiments carried out on the healthy and on the ill person. Numerous discussions on consent have taken place and we also have participated in them and have come to the conclusion that during human non-therapeutical experimentation, carried out in the interest of the community with no concern for the subject’s own interest, the consent is the conditio sine qua non because in the absence of it each and every experiment is axiomatically illicit. On the contrary, in therapeutical experimentation the consent, which can never be informed, free, or spontaneous, does not offer a guarantee that the experiment will be carried out solely in the patient’s therapeutic interest. The consent, in reality, because of the importance attributed to it, is often used as an alibi for incorrect experiments and risks drawing one’s attention and care away from the ethical problems which are present at every stage of the research. These are so numerous that if they were listed they could add distressingly to our knowledge of how frequently they are neglected. They range from a not respected fulfilment of each stage of the experimentation (experiments on the healthy, for instance, are hardly ever carried out) to a lack of adequate techniques for a correct estimation of parameters judged to be prejudicial to the continuation of the research. One jumps from experiments carried out on one individual sick man to all sick men and therefore you are back where you started from, you are once again back to industry and the market laws, the laws of profit.
Ethical
problems
in psychopharmacological
research
289
Under these circumstances we do not deem it suitable to carry out a particular analysis of the ethical aspects related to each individual stage, but we feel that we have to spend some This time over such aspects which deal with psychopharmacological research in its totality. is because it is subject to a law different from that concerning ethics and above all because the sometimes tragic symptoms of the noxious effects of substances deemed therapeutical spark off justified protests that, in the most exasperated cases, reach so far as to condemn pharmacological research in toto. 4.
Relationship
Between
Science
and Technology
This condemnation is part of an attitude of those who refuse to accept science. Thus you become involved in the heated debate which has been going on for several years, as Rabinowitch (1972) says, about the fear that strikes people as the research progresses. This fear is now increasing and, sooner or later, will also hit Eastern countries, where science and technology are still considered to be the constructive power freeing man from poverty and hard work and where no one dares speak about the unfavourable aspects of technology, with the Here emphasis is laid on its good qualities (construction exception of the nuclear threat. of dykes, space travel and other achievements). In the scientific era man gains security and loses innocence. He gains knowledge of danger, but not the wisdom to confront it, for his defenses are still of an emotional sort. "Guard yourself against truth, truth which will turn you into a slave" is a slogan which badly reechoes the theme of the dialectics of illuminism and brings in the pessimistic view that which is modern no longer coincides with that which is human. However, in view of the fact that the new discoveries can be more readily used by those who detain the political and economical ascendancy and therefore they inevitably lead to a power concentration and are intrinsically a plight which is becoming more and more diffused and intense throughout society, the discomfort is becoming even more severe. There arises the problem of the relationship between science and technology, basic research Upon this distinction many authors satisfy their whims and there prevails and applications. a certain tendency to preserve science while condemning its handmaid, technology. In many cases, however, the boundary-line between the two is so indistinct that to condemn the one is to condemn the other and in doing so the relationship between science and progress is also involved. Let us see what the philosopher Paolo Rossi (1976), an authority on this subject, has to say. According to him, the term progress has two different meanings. On the one hand it denotes the passage from less particular and less rigorous theories to more particular and more rigorous ones, on the other "something" which has to do with values, hope, expectation, which refers to a desirable future, to a "searching" for something better. This distinction seems necessary as there are in fact people who believe, for example, that the growth of science has not and does not contribute at all to progress in the human race but that it rather resembles the disorderly proliferation of a tumour. "The exponents of the literature of the Apocalipse, those who support primitivism and the healthy rustic life, the followers of irrationalism, the theorists of left-wing counterculture and the assertors of the so-called right-wing radicalism agree today" as Rossi says "on this kind of diagnosis and aspire to a world without science, which would be better than the present 0ne.u . While talking of progress Levin's scheme (1969) comes to mind. According to him the history of this idea is firmly intertwined not only with the story of Utopia but also with that of millenarianism and primitivism. "Whoever believes in progress, however, is usually not content with choices to be made in the realm of imagination. He does not accept the flight from history. He counts on, or believes he can count on, real possibilities or those he interprets as real" (Rossi, 1976). On the other hand, it is better not to forget ship between science, technology and progress is assertor of "pure technician", in his interpretation sive mechanicus" (1609) had depicted the figure genius but of very bad char;Lcter", renowned for which permitted Pasife to couple with a bull and
that the difficult and questionable relationnot new. Bacon, misleadingly considered an of the myth of Daedalus in "Daedalus of Daedalus as that of a "man of the greatest "unlawful inventions" such as the machine procreate the Minotaur devourer of youths,
C. Gentili
290
and G. Ferrari
Besides, conand the Labyrinth, devised to hide the Minotaur and to protect evil with evil. and also instruments of come instruments of lust, tinues Bacon, "out of the same fountain poisons, also guns, and such like engines of destruction, death . . .Por . ..the most exquisite and well we know how far in cruelty and destructiveare the fruits of mechanical invention; ness they exceed the Minotaurus itself." The greatest revolutionary moments in science Knowledge, progress, come through suffering. who has taken away from man his central position in have thus humiliated man: Copernicus, the universe; Darwin, who has shown man that there is no difference between him and the other animals; Freud, who has rid man of the illusion of owning his own self. The price that has to be paid to leave behind childlike innocence, a world of narcissism, in the omnipotence of thought (historically the moment of magic) that is, to stop believing to achieve the adult awareness of the loss of omnipotence (the moment of science) is made up of humiliation, a humiliation through which is maturity, knowledge, consciousness. As Rabinowitch writes, man cannot turn from maturity through knowledge back to innocence through ignorance. Perhaps mankind needs to discover new values, a new philosophy, maybe even a new We must make a religion, but all this must include and not exclude scientific knowledge. complete use of scientific capacity and not do away with it. The only real defense against knowledge is a greater knowledge. There is no need to resort A more rational use must be made of our knowledge, we must not stop treating to ignorance. illness, as Illich (1967) would ask us to, or refuse drugs, but gain more knowledge on their use; the answer to the noxious side effects of technology is certainly not a return to the past, not an abandon of progress, but perseverance in order to find a better and safer technology. Therefore neither the position of primitivism nor that of millenarianism are ethical. Once again it is Bacon who reminds us that Daedalus, ll... the same man who devised the mazes of the Labyrinth, disclosed likewise the use of the clue. For the mechanical arts may be turned either way and serve as well for the cure and for the hurt and have power for the most part to dissolve their own spell." As Maddox says in "The Doomsday Syndrome" (1973), the disasters which ecologists study, such as the toxicity of many substances, have been discovered only on behalf of the knowledge which science has produced and a more and more sophisticated technology. Adorn0 (1969), although in discordance with positivism, has written: "The devastation brought about by progress must be remedied by the power of progress but never by a restoration to the previous conditions which have become its victim." 5.
Control
andRegulations
in Drug Trials
Therefore the only solution possible is to control errors arising from technology with improved technical instruments, that is to say with those which allow for more valid criteria of judgement. This is the leading ethical aspect which is pointed out by the philosophers of science to whom we have turned till now. However, we must not forget that for every existing technique exploiting it in his own interest and at this point the problem political and judicial,
there is always someone is no longer ethical but
All the authors previously consulted and quoted, rightly contrary to refuting science, agree on the necessity to control technology. And we also, having taken into consideration the various regulations, rules, provisions, laws in force and disparate from one country to the other, which divide and invalidate one another, find it necessary, ethical in this case, to suggest the founding of an international committee. Through a supranational cooperation this would be capable of controlling the industry which is, as has been frequently said, at the beginning and at the end of the drug, and which always, because of the law of profit, is present more or less hidden, sapping the ethical aspect of the experiment for it acts on a different level. This international control, although it would not solve the ethical problem, as it would not limit science in its evolution, should aim at freeing it from the gloomy Promethean feelings of guilt, preventing a wrong use of it. This committee is a must, a4 is also possible since, thanks to science, as Le Roy wrote way back in the 17th century "...the whole world
Ethical
problems
in psychopharmacological
research
Men can now freely exchange their and each and every race have been discovered. and help one another, just like the townsmen belonging to one and the same city" 1657).
291
inventions (Le Roy,
This supranational organization, possibly originating from the WHO, would have to face a multinational power such as industry, give tangible proof that science belongs to everybody, unlike magic which belongs only to a few; such a control would start off a new path, culture, ideology, which would lead to a political view of a world that, as we have been saying, science with its good and evil helps along. This cormnittee, besides co-ordinating and overcoming the inadequate regulations the various countries, should be provided with legislative and functional tools guarantee each stage of the experiment.
in force in in order to
Above all it should overcome the inevitable clash between the directive manner of procedure and that of participation which considers the principle of health as a right and duty of the citizen from the moment we reach the human stage of experiment, when a drug is given to the subject or the subject is asked to decide whether to take it or not. In our' opinion only the citizens' participation through an elective committee (as is the case in a few Italian regions) can overcome this clash. With such a local committee the problem of consent would lose in juridicial importance and at the same time the individual, who is the object of the experiment, would take part in it, so that an experiment would be carried out not on man but with man. If these two forms of control, effect, the Nuremberg Decalogue to ours, marked by the supreme of its meaning.
the supranational loses importance ethical principle
and the peripheral one, are not put into and the spirit of the constitutions similar "Utmost respect for the person", is emptied
References ADORNO, T. W. (1969). Stichworte kritische Modelle. Suhrkamp Verlag, Frankfurt am Main: BACON, F. (1858). Works. Spedding, London VI. Inter-vent0 alla "Tavola rotonda sulla regolamentazione della sperimentaGENTILI, C. (1974). zione clinica in Italiau. Rass. clin.-scient. 50: 3-6. GENTILI, C., ALVARO, G., CARTA, A., FERRARI, G., SONTALI, G. and GIORDANI, L. (1972). Considerazioni etico-giuridiche sulla sperimentazione di farmaci nuovi nell'uomo. Rass. l-38. clin .-scient. 12: ILLICH, I. (1967r Limits to Medicine: Medical Nemesis. The Expropriation of Health. Boyars, London. LFs ROY, L. (1657). ConsidCrations sur l'histoire universelle. Paris, VIII. LEVIN, H. (1969). The Myth of the Golden Age in the Renaissance. Quoted by Rossi. MADDOX, J. (1973). The Doomsday Syndrome. Quoted by Rossi. RABINOWITCH, E. (1972). Living dangerously in the age of science. Bull. At. Sci. 28: 5-8. ROSSI, P. (1976). Sulle origini dell'idea di progresso. In: I1 Concetto di Progress0 Nella Scienza. Feltrinelli, Milano. Snquiries
and reprint
C. Gentili Istituto di Psichiatria Universita di Bologna,
requests
should
"P. Ottonello" Italia
be addressed
to:
s
Newo-Peychophazmacot.
Vo1.3,
pp.287-291,
1979.
Press Ltd.
Pergamon
RI’HICAL PROBLEMS IN PSYCEOPHARMAcoLOGIcAL C. GENTILI Istituto
Printed
in Great
Britain
RESEARCH
and G. PPXRARI
di Psichiatria "P. Universita di BO~Q~IUI,
Ottonello", Italia
Contents 1. 2. 2.1. 2.2. 3. 4. 5.
Abstract Introduction Medical ethics and psychopharmacological research Preclinical phase Clinical phase The consent in human therapeutical and non-therapeutical Relationship between science and technology Control and regulations in drug trials References
287 287 288 288 288 288 289 290 291
trials
Abstract I. 2. 3. 4.
Key
Scientific research poses considerable ethical problems which in human psychopharmacological studies are frequently faced by singling out consent as the only reliable source of human respect, although it is never free, spontaneous, or informed. On the other hand, various ethical problems present in the "life" of a new substance in the case of industry and preclinical, clinical and mass experiments, are left behind. Thus there arise justified protests which go so far as disowning science and technology. use of them must be prevented. To criticize science and technology is of no use: incorrect Such a guarantee can only come from an international control committee, capable of coping with a multinational power such as industry, supported by peripheral elective coassittees, which grant the citizens a direct participation in the administration of health. words:
consent in pharmacological research, control relationship between science and technology,
1. The adjective we are already some difficulty
in drug trials, human respect
ethics and drug
in research, trials.
Introduction
"ethical", included in the title, acquainted with the subject (Gentili in sketching out our presentation.
brings out an uncertainty et at., 1972; Gentili,
which, although 1974), has raised
Ethical concerns a whole series of concepts such as science, technology, progress, right, so as to arrive at a logical and coherent which oblige to precise and clear definitions, argument. This already appears to us a necessary attempt in order to proceed to the description in an ethical manner. In fact ethical concerns not only the formulation and the description of the phenomenon, but also the methodology, the steps and instrlnnents needed for the correct comprehension and solution to the problems which the phenomenon itself poses. So ethical means correct or good.
C.
288
This adjective, praxis requires and on the other
As
Medical
Ethics
experimental research above all in a general problems are met with in the various clinical and the human or clinical. upon them as they are fragmentary the global ethical problem which 2.1.
far
as
but
Preclinical
and
G.
Ferrari
when applied which pertains to moral philosophy, a coherence which on the one hand will fulfil each will impose sound judgement to each and every side
2.
stage,
Gentili
and
Psychopharmacological
to an ideology aspect and time of them.
or to a of them
Research
ethical problems appear constantly at every is concerned, So, in psychopharmacological research such formulation. moments of its two fixed stages, the pre-human or preThough they are important, we do not intend to dwell and we could say surpassed in as much as they are part of is at the basis of the entire research.
phase
Therefore we shall limit ourselves to remember how, in the first pre-human or pre-clinical phase, we begin by searching for new active principles and by singling out and choosing subThere follows an attempt to collect the data and to come to a reastances for experiment. soned conclusion on the tests carried out on the animal in order to apply the substances for clinical use. Usually this stage is carried out by the pharmacological industry which is bound to market and profit laws and therefore acts differently from the ethical model. The the different attempt on correct work at such a level is constant also for other reasons: effects of drugs on animal species, the determination of the efficacious dose, the methodological choice of the biochemical and behavioural parameters to be used, and the appraisal of their predictable value. 2.2.
Clinical
phase
The transition to clinical experiments, that is to say, to man (in its various stages: pharmacodynamics. therapeutical experiments, planned experiments, generalized therapeutical experiments and, finally, the study of the long-term effects of a drug) involves further obstacles to be overcome in order to proceed correctly, i.e. the difficulty in singling out the somatophysiological and psychological parameters which have to be considered in order to obtain reliable responses firstly in the healthy human being and later in the patient.
3,
The
Consent
in
Human
Therapeutical
and
Non-Therapeutical
Trials
At this point the respect for the person takes first place, respect that has received acknowledgement with the Nuremberg Decalogue and with the Helsinki Charter, which we are all acquainted with. These documents have emphasized the importance of the consent both for the experiments carried out on the healthy and on the ill person. Numerous discussions on consent have taken place and we also have participated in them and have come to the conclusion that during human non-therapeutical experimentation, carried out in the interest of the community with no concern for the subject’s own interest, the consent is the conditio sine qua non because in the absence of it each and every experiment is axiomatically illicit. On the contrary, in therapeutical experimentation the consent, which can never be informed, free, or spontaneous, does not offer a guarantee that the experiment will be carried out solely in the patient’s therapeutic interest. The consent, in reality, because of the importance attributed to it, is often used as an alibi for incorrect experiments and risks drawing one’s attention and care away from the ethical problems which are present at every stage of the research. These are so numerous that if they were listed they could add distressingly to our knowledge of how frequently they are neglected. They range from a not respected fulfilment of each stage of the experimentation (experiments on the healthy, for instance, are hardly ever carried out) to a lack of adequate techniques for a correct estimation of parameters judged to be prejudicial to the continuation of the research. One jumps from experiments carried out on one individual sick man to all sick men and therefore you are back where you started from, you are once again back to industry and the market laws, the laws of profit.
Ethical
problems
in psychopharmacological
research
289
Under these circumstances we do not deem it suitable to carry out a particular analysis of the ethical aspects related to each individual stage, but we feel that we have to spend some This time over such aspects which deal with psychopharmacological research in its totality. is because it is subject to a law different from that concerning ethics and above all because the sometimes tragic symptoms of the noxious effects of substances deemed therapeutical spark off justified protests that, in the most exasperated cases, reach so far as to condemn pharmacological research in toto. 4.
Relationship
Between
Science
and Technology
This condemnation is part of an attitude of those who refuse to accept science. Thus you become involved in the heated debate which has been going on for several years, as Rabinowitch (1972) says, about the fear that strikes people as the research progresses. This fear is now increasing and, sooner or later, will also hit Eastern countries, where science and technology are still considered to be the constructive power freeing man from poverty and hard work and where no one dares speak about the unfavourable aspects of technology, with the Here emphasis is laid on its good qualities (construction exception of the nuclear threat. of dykes, space travel and other achievements). In the scientific era man gains security and loses innocence. He gains knowledge of danger, but not the wisdom to confront it, for his defenses are still of an emotional sort. "Guard yourself against truth, truth which will turn you into a slave" is a slogan which badly reechoes the theme of the dialectics of illuminism and brings in the pessimistic view that which is modern no longer coincides with that which is human. However, in view of the fact that the new discoveries can be more readily used by those who detain the political and economical ascendancy and therefore they inevitably lead to a power concentration and are intrinsically a plight which is becoming more and more diffused and intense throughout society, the discomfort is becoming even more severe. There arises the problem of the relationship between science and technology, basic research Upon this distinction many authors satisfy their whims and there prevails and applications. a certain tendency to preserve science while condemning its handmaid, technology. In many cases, however, the boundary-line between the two is so indistinct that to condemn the one is to condemn the other and in doing so the relationship between science and progress is also involved. Let us see what the philosopher Paolo Rossi (1976), an authority on this subject, has to say. According to him, the term progress has two different meanings. On the one hand it denotes the passage from less particular and less rigorous theories to more particular and more rigorous ones, on the other "something" which has to do with values, hope, expectation, which refers to a desirable future, to a "searching" for something better. This distinction seems necessary as there are in fact people who believe, for example, that the growth of science has not and does not contribute at all to progress in the human race but that it rather resembles the disorderly proliferation of a tumour. "The exponents of the literature of the Apocalipse, those who support primitivism and the healthy rustic life, the followers of irrationalism, the theorists of left-wing counterculture and the assertors of the so-called right-wing radicalism agree today" as Rossi says "on this kind of diagnosis and aspire to a world without science, which would be better than the present 0ne.u . While talking of progress Levin's scheme (1969) comes to mind. According to him the history of this idea is firmly intertwined not only with the story of Utopia but also with that of millenarianism and primitivism. "Whoever believes in progress, however, is usually not content with choices to be made in the realm of imagination. He does not accept the flight from history. He counts on, or believes he can count on, real possibilities or those he interprets as real" (Rossi, 1976). On the other hand, it is better not to forget ship between science, technology and progress is assertor of "pure technician", in his interpretation sive mechanicus" (1609) had depicted the figure genius but of very bad char;Lcter", renowned for which permitted Pasife to couple with a bull and
that the difficult and questionable relationnot new. Bacon, misleadingly considered an of the myth of Daedalus in "Daedalus of Daedalus as that of a "man of the greatest "unlawful inventions" such as the machine procreate the Minotaur devourer of youths,
C. Gentili
290
and G. Ferrari
Besides, conand the Labyrinth, devised to hide the Minotaur and to protect evil with evil. and also instruments of come instruments of lust, tinues Bacon, "out of the same fountain poisons, also guns, and such like engines of destruction, death . . .Por . ..the most exquisite and well we know how far in cruelty and destructiveare the fruits of mechanical invention; ness they exceed the Minotaurus itself." The greatest revolutionary moments in science Knowledge, progress, come through suffering. who has taken away from man his central position in have thus humiliated man: Copernicus, the universe; Darwin, who has shown man that there is no difference between him and the other animals; Freud, who has rid man of the illusion of owning his own self. The price that has to be paid to leave behind childlike innocence, a world of narcissism, in the omnipotence of thought (historically the moment of magic) that is, to stop believing to achieve the adult awareness of the loss of omnipotence (the moment of science) is made up of humiliation, a humiliation through which is maturity, knowledge, consciousness. As Rabinowitch writes, man cannot turn from maturity through knowledge back to innocence through ignorance. Perhaps mankind needs to discover new values, a new philosophy, maybe even a new We must make a religion, but all this must include and not exclude scientific knowledge. complete use of scientific capacity and not do away with it. The only real defense against knowledge is a greater knowledge. There is no need to resort A more rational use must be made of our knowledge, we must not stop treating to ignorance. illness, as Illich (1967) would ask us to, or refuse drugs, but gain more knowledge on their use; the answer to the noxious side effects of technology is certainly not a return to the past, not an abandon of progress, but perseverance in order to find a better and safer technology. Therefore neither the position of primitivism nor that of millenarianism are ethical. Once again it is Bacon who reminds us that Daedalus, ll... the same man who devised the mazes of the Labyrinth, disclosed likewise the use of the clue. For the mechanical arts may be turned either way and serve as well for the cure and for the hurt and have power for the most part to dissolve their own spell." As Maddox says in "The Doomsday Syndrome" (1973), the disasters which ecologists study, such as the toxicity of many substances, have been discovered only on behalf of the knowledge which science has produced and a more and more sophisticated technology. Adorn0 (1969), although in discordance with positivism, has written: "The devastation brought about by progress must be remedied by the power of progress but never by a restoration to the previous conditions which have become its victim." 5.
Control
andRegulations
in Drug Trials
Therefore the only solution possible is to control errors arising from technology with improved technical instruments, that is to say with those which allow for more valid criteria of judgement. This is the leading ethical aspect which is pointed out by the philosophers of science to whom we have turned till now. However, we must not forget that for every existing technique exploiting it in his own interest and at this point the problem political and judicial,
there is always someone is no longer ethical but
All the authors previously consulted and quoted, rightly contrary to refuting science, agree on the necessity to control technology. And we also, having taken into consideration the various regulations, rules, provisions, laws in force and disparate from one country to the other, which divide and invalidate one another, find it necessary, ethical in this case, to suggest the founding of an international committee. Through a supranational cooperation this would be capable of controlling the industry which is, as has been frequently said, at the beginning and at the end of the drug, and which always, because of the law of profit, is present more or less hidden, sapping the ethical aspect of the experiment for it acts on a different level. This international control, although it would not solve the ethical problem, as it would not limit science in its evolution, should aim at freeing it from the gloomy Promethean feelings of guilt, preventing a wrong use of it. This committee is a must, a4 is also possible since, thanks to science, as Le Roy wrote way back in the 17th century "...the whole world
Ethical
problems
in psychopharmacological
research
Men can now freely exchange their and each and every race have been discovered. and help one another, just like the townsmen belonging to one and the same city" 1657).
291
inventions (Le Roy,
This supranational organization, possibly originating from the WHO, would have to face a multinational power such as industry, give tangible proof that science belongs to everybody, unlike magic which belongs only to a few; such a control would start off a new path, culture, ideology, which would lead to a political view of a world that, as we have been saying, science with its good and evil helps along. This cormnittee, besides co-ordinating and overcoming the inadequate regulations the various countries, should be provided with legislative and functional tools guarantee each stage of the experiment.
in force in in order to
Above all it should overcome the inevitable clash between the directive manner of procedure and that of participation which considers the principle of health as a right and duty of the citizen from the moment we reach the human stage of experiment, when a drug is given to the subject or the subject is asked to decide whether to take it or not. In our' opinion only the citizens' participation through an elective committee (as is the case in a few Italian regions) can overcome this clash. With such a local committee the problem of consent would lose in juridicial importance and at the same time the individual, who is the object of the experiment, would take part in it, so that an experiment would be carried out not on man but with man. If these two forms of control, effect, the Nuremberg Decalogue to ours, marked by the supreme of its meaning.
the supranational loses importance ethical principle
and the peripheral one, are not put into and the spirit of the constitutions similar "Utmost respect for the person", is emptied
References ADORNO, T. W. (1969). Stichworte kritische Modelle. Suhrkamp Verlag, Frankfurt am Main: BACON, F. (1858). Works. Spedding, London VI. Inter-vent0 alla "Tavola rotonda sulla regolamentazione della sperimentaGENTILI, C. (1974). zione clinica in Italiau. Rass. clin.-scient. 50: 3-6. GENTILI, C., ALVARO, G., CARTA, A., FERRARI, G., SONTALI, G. and GIORDANI, L. (1972). Considerazioni etico-giuridiche sulla sperimentazione di farmaci nuovi nell'uomo. Rass. l-38. clin .-scient. 12: ILLICH, I. (1967r Limits to Medicine: Medical Nemesis. The Expropriation of Health. Boyars, London. LFs ROY, L. (1657). ConsidCrations sur l'histoire universelle. Paris, VIII. LEVIN, H. (1969). The Myth of the Golden Age in the Renaissance. Quoted by Rossi. MADDOX, J. (1973). The Doomsday Syndrome. Quoted by Rossi. RABINOWITCH, E. (1972). Living dangerously in the age of science. Bull. At. Sci. 28: 5-8. ROSSI, P. (1976). Sulle origini dell'idea di progresso. In: I1 Concetto di Progress0 Nella Scienza. Feltrinelli, Milano. Snquiries
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