Open letter to practitioners, researchers, operators and health institutions

Since several years, men and women of different cultures and realities, all over the world, without equal opportunities and resources, move on December the 1st to affirm, although differently, the rights of persons with HIV and AIDS.

This year the World Health Organization decided to call everyone for a commitment on a particularly meaningful topic, rights and responsibilities in a sharing spirit. To us, sharing rights and responsibilities means to meet one another, bringing the own experience and the own peculiarity in order to put it at stake, to compare and to solve problems together.

We don' t want to consider all aspects related to rights and responsibilities (guaranteed or denied, assumed or disappointed) but we wish to underline the concept of sharing for one of the most troubled topics, that of therapies, of the practitioner-patient relationship which should increasingly assume the character of therapeutic alliance.

Reflections about some HIV infection peculiarities

The following considerations are the result of observations, instances and thoughts which are brought by many persons with hiv or aids addressing our services. They are also general reflections which we want to pose directly and in an open spirit. A working and reflection agenda, not a decalogue or a completed thought, it is only the proposal of a clear dialogue, aware that there are no right o wrong parts, but a single, big part which is our society's quality and that of the relation between citizen and services, which being imperfect can always be improved, and for some aspects, to us, it is urgent to improve.

From our work some considerations emerged that we propose to you. In particular, the absence of a resolutive therapy, imposes some reflections.

We don't want to say that all the therapies are on the same level. Some of these are seriously validated, others are experimental, other ones have no experimentation paths or those are still incomplete. But this very complexity and the existence of different opinions on effectiveness and safety of single treatments, suggest however a problematic and open approach, careful and not dogmatic, although rigorous. The 1994-95 period is, in this sense exemplifying, where the early treatment of infection with AZT was differently considered (also by official medicine) according to the significance assigned to the Concorde Study results.[1, 2]; or, as another example, the different significance assigned to quality of life as to the choice to prescribe AZT also considering that some studies "suggest that practitioners should try to introduce patient's preferences in treatment indications, instead taking such decisions alone according to CD4 values and to designed guidelines." [3] These are only some examples which suggest a problematic and therefore, open approach.

It is necessary to give much more significance to scientific updating but also a continuity of information to the person. In other words, the resource information is not only a professional duty for the practitioner but also a person's right. We mean that sometimes the signing of an "informed consent" is prevalently a hasty and formal act, while it should be an important chance of communication and information, which includes also an accurate, and not formal, information on possible alternatives. Further, be believe that it should be a permanent practice4 and that it should also concern already validated and authorized therapies which, in the meantime, have been further examined.

It is necessary to give significance to therapeutic relation without reducing it to simple administration of what the pharmacological panoply allows, but paying attention to the person, her doubts, her orientations, her identity, to the possibility of personalizing therapy. It is not our intention to affirm that this is not being done, but that it is important to make further steps in this direction. Lack of or little patient's compliance to treatments may be further faced and promoted. Compliance is not only determined a by the sick person, but it is also a result of the practitioner's "listening and doing ability", of his ability to pay attention to the patient's problems. The more this " listening and doing ability " should be an organic part of every practitioner's culture, of its ethics and professionalism; a qualifying part of his/her professionalism which involves availability and preparation to communication, awareness and right recognition.

It is necessary to attach importance to the person as a therapeutic resource. The different disease evolution (quick, slow, and apparently lacking after 15 years from infection) suggest that other than exogenous (strain typology, viral load at infection, infectious aggravation, etc.), may exist endogenous factors able to fight infection and/or, however, to influence its evolution. These factors might be disturbed or compromised by exclusively protocol treatments and may be they need an individualized treatment.

Hiv infection, according to its nature, and due to a lack of a resolutive therapy, further amplifies the use of unconventional therapies (alternative, etc.) It is necessary that therapeutic relationship, in unconventional medicine, exits from the enclosed practitioner-patient relationship and stands a comparison publicly for debate. It is necessary that these practitioners make their treatment criteria public, the remedies used and the reasons of their choices, their treatment results. In order to do this they have to find a receptivity outside, a dialogue availability, but it is necessary for them to expose, making some steps ahead. These practitioners, as anyone else working to help persons with hiv, both of conventional or unconventional schools, will certainly find careful interlocutors in AIDS fighting organizations and in persons hiv.

A knot to unloose

During centuries the person's position in society has changed from an absolute disparity (the emperor and the slave) to a position of civilization (the citizen, of whatever social position).

Today this positive idea of the person should belong to our culture. Transitions and historical passages which leaded to this ultimate situation are different and present controversial aspects. For example, the right to health may be understood as the society's right to decide for the person or, on the contrary, the right-duty of the society to protect the person's right to choose.

The first pattern implies a double situation. On one hand it assumes the medicine to be unique and an always exact science, that only one way exists to cure a disease (the own). On the other hand it assumes the sick person not to have the tools to understand and that, different from the practitioner, she is involved, factor which may invalidate her clearness. This conception necessarily retains (declaring it or, increasingly, only thinking and doing it) the practitioner be the only decisional pole, the rest is conviction, research for consent.

The second pattern (but there are others ones) retains that in some cases different ways to cure a disease may exist, all however deserving attention and evaluation. This not self-centered approach uses a principle of reality; the observation that in western countries the same diseases are treated in a way, while in Asia, in Africa and South America, in other ways; but also that some diseases in the same country (in Italy for example) are treated with good results by official medicine, as -for example- by homeopathy. If this wasn't enough it should be noticed that they are however graduated practitioners (may be at the same University), of official medicine, homeopathy, Chinese traditional medicine practitioners, etc. Is it about suddenly mad persons or people who are looking for easy gains? No!! We affirm this with absolute certainty thanks to logic and knowledge. Then we start from the supposition that different medicines exist, not all equally validated, studied and guaranteed, but all potentially useful for the person.

Further, this second pattern looks at the person as a citizen able to judge the practitioner's seriousness and the information completeness. It conceives the sick citizen as the owner of rights in a positive way, to be exerted for oneself.

Of course there are risks, but it is about risks operating in all directions (conventional medicine or not) and, however, there is a way to fight it and contain it. Punctual information, experimentation, phenomenon knowledge and not its denial and despondency are possible ways to intervene with effectiveness.

Between the two patterns we recognize ourselves in the second one and we think that our Constitutional doctrine also has moved in this direction. Indeed, from a negative conception - for the person's autonomy - of health, with a prevailing role of censorship with the purpose to protect Public Health, we switched to a positive position of "individual right to health" which assigns a priority to the individual right. That's exactly what the Constitutional Court wanted to affirm in 1990 with sentence n. 471 which has combined the right to health not only with the 32nd art. of Constitution but also with 13th of the same, (personal freedom) decreeing the person's freedom to dispose of her own body [5, 6].

We therefore think that the acknowledgment of autonomy, the ability to understand, the dignity of the citizen and that of the sick person, belong to our civil culture. We believe that coherently with this Public Health interventions shall be, as to different medicines, prevailingly of informative and verifying character (research on effectiveness and safety, control on products' quality), not exclusively repressive.

A not privatistic conception of the Public Health suggests an attention (as service) to any therapeutic opportunity and to any need and orientation expressed by the citizen, in order to verify and study, inform and enable the citizen. We hope that this health culture will increasingly characterize our societies.

Conventional and unconventional medicine

For unconventional therapies we mean different realities: the purely traditional medicine (as the Chinese Traditional Medicine, Ayurveda, Tibetan etc.), alternative ones (as today may be considered Homeopathy in some European countries) or complementary (as might be Nutrition Science). According to orientations we could assign - for example - Phytotherapy to traditional medicines (if we think of the past) or alternative (if we think of the present).

Various researches published between 1993-1995 showed a wide complementary therapies (CT) use in USA, in Europe and in Australia. It emerged that in USA7 one citizen out of three uses CT and that 72% don' t communicate this to his/her practitioner of official medicine; in Australia, [8] the first SMASH report of 1994 highlighted that among persons with hiv two out of three use CT. In 1993, from an investigation among "HIV Herald" readers, emerged that to the question "What should we treat more?" the answer was: "A greater information on HIV and AIDS complementary therapies". A European research [9] documented that the European (also Italian) use of CT is well-established and the demand is increasing, as well as the presence of CT practitioners (Acupuncture, Homeopathy, Phytotherapy, etc).

In countries other than USA, there is an interest for these medicines at Institutional and Academic level [10,11]. In Germany [12] and in England [13] also a different attention is payed to these medicines.

In Italy there are no analogue researches, but preliminary data [14, 15, 16] show that the situation is not so different from the rest of Europe and America. It is only a more recent and chaotic phenomenon, as there are less information and less resources in this field, both by public part or voluntary service and activism for the fight to aids.

If we pay attention to the situation in our country we notice that conventional medicine is recognized and practiced in hospital circles, it has own experimentation and validation paths, own funding sources (private or public); while unconventional one is exclusively practiced in private surgeries with approximate respect of the rules; it usually lacks of research areas and it doesn't take advantage of any public research contribution.

All "fine", if it wasn't about same patients, same citizens. This trivial consideration highlights the need to create structured channels of communication and comparison among practitioners of conventional and unconventional medicine. Different, for experimentation, bias and other shapes of research invalidation risks (for treatments overlapping, for a posology readjustment based on suggestions external to experimentation team, etc) are unavoidable; as on a treatments level, the smaller compliance, risk of negative synergies, presence of little or uncontrolled dynamics.

Further, we try to look ahead, at the next decades. If, in USA, a greater attention to unconventional therapies is paid, it is not only due to a different health organization, different position of the citizen as to State, different history of self-help, different ability by associations to incise; but also the fact that in the past decade strong immigration involved the creation of a big community, which brought about new social and medical cultures. This probably will happen in Italy, it concerns only to operate with wisdom and the awareness of dynamics beyond wishes and personal convictions. The co-presence of different medicines, the globalization of different medical traditions is, according to us, written also in our country's next future history.

We therefore start from the consideration that a meeting among medicines is not only unavoidable but wise also.

We believe that our health authorities have to help this path, favoring research on unconventional therapies also. The warning coming from a researcher as Luc Montagnier is clear and explicit "A comprehensive evaluation of these approaches which shouldn't exclude neither the use of plant extracts (considering they are the best chemists in nature), nor antioxidant molecules is needed. Some ways, which seem promising to everybody, benefit from numerous financial credits, despite others, which seem accessory and are disregarded. Researches however have to be conducted in all directions, no way has to be excluded: it is the so-called "research at risk", of which I have always been strong advocate" [17]

Further, in our country there is a lack of organic information interventions on complementary therapies, while in foreign countries since several years organic informative agendas about these topics are realized [18, 19, 20, 21, 22] The unique experiences in this sense are animated by AIDS fighting associations, as for example, the Poiesis Center of Exodus Group which has a documentation and information service on complementary therapies.

It is necessary to promote these activities in other cities also and to realize a net of documentation and information about these topics to put at therapist's, practitioners' and persons' with hiv and aids disposal.

These and other problems were raised, during the course of the 3 day residential study Seminary, held in Bocca di Magra last May. At the end of the works 135, among researchers, practitioners, persons with hiv, approved a final motion [23] which proposes the establishment of a National Observatory about complementary therapies for hiv and aids. A group of associations [24] worked on this proposal and is about to inaugurate the establishment of the Observatory [25] .

From these considerations we deduce the formulation of some rights

 1) A person doesn't stop to be such when she is sick, she keeps same dignity, ability and rights.

This affirmation may sound obvious, but it is not. Persons with hiv and aids turn to associations to complain their practitioners to behave aggressively, because of their different consideration of therapies. In other words, it happens that a refusal of consumption of currently used antiretroviral drugs, or a decision to use unconventional remedies, can be understood by some practitioners as a deed legitimizing a smaller commitment, which favors and "justifies" disengagement. That is: noticing that you don't use my drugs then I put in discussion the cadence and even clinical monitoring and check-up. This is an evident irregular and unethical action. It is important that the person, apart her therapeutic choice, remains in contact with the Service and that medical check-ups, as examinations, be regular. It is important that the Public Health Service starts monitoring these situations and gathering elements of evaluation.

 2) The Person is holder of the right to self-determination. Ethical codes clearly affirm that "the principle of the respect involves (…) respect for autonomy, which requires self-determination ability of those people who are able to deliberate their personal choices" [26]

 3) In democracy public scientific research shouldn't be an autarchic context, privately conducted, but a common resource, a service towards society which- in last instance- is represented by citizen. A demand for unconventional therapies goes along with a request for research, with the need to also destine in this direction public research.

For instance, the presence of three million homeopathic remedies users (clearly gaining a benefit, unless considering them all interdicted) has the same, if not greater value, than obstructionism to recognizing of the homeopathic profession by the Practitioners Order.

In this sense society and its organizational shapes represents, as other instances, a licit and representative moment of instances. Many associations for the fight against AIDS have many times requested an interest, without any particular result; different from what has happened in other countries, where the intervention of associations of sick persons gave really different and meaningful results [27]. We think the right way to be another: of attention, of resources destination, of research and finally of evaluation.

 4) Consequently to what we have just mentioned it is necessary that specific experimentation paths for unconventional therapies be defined. The reasons for the lack of unconventional therapies research are various [28] but among these there is the relevant fact that drugs registration paths are generally long and expensive, and it is difficult, if not impossible, to find companies which invest great amounts on products of which they will hardly obtain a patent and trading monopoly. For this reason also, the World Health Organization, in its document, proposes the "Reasonable Safety Doctrine" strategy [29]. The most important postulate of this proposal is that, while basing only on in vitro and animal tests experimentation, new synthesis molecule trials are performed on humans, no clinical tests are made on those medicines which, even though they were used for centuries by traditional medicine (with a possible direct data extrapolation and on humans with respect to strong and chronic toxicity) lack of part of the very expensive pre-clinical dossiers. This way, these therapies are not further examined about their real effectiveness and possibility to be . improved in posology, in formulation, etc…

WHO proposes to solve this problem through the "Reasonable Safety Doctrine", Where there exist in the literature and in official pharmacopoeia, usable data able to show toxicity and possible effects, they may be considered as an alternative to pre-clinical documentation and should be possible to activate clinical researches about these remedies. This is a very reasonable position to which we fully agree.

We retain this approach to be interesting and we think that it is important to study some alternative shape of pre-clinical dossier which may better match the concrete situation of traditional medicine and may promote research.

 5) Also, it is necessary, to conjugate pharmacological research times (5-15 years for regulation and approval of a drug) with current life expectation of persons with hiv and aids.

It is necessary to support "traditional" study trials with easier experimentation designs, using more specific tests (as the viral load) which may provide, in a shorter time, preliminary results about therapy effectiveness.

In this fast lead of research also finalized to persons with hiv, it would be appropriate to intervene also through the institution of "accelerated approval protocols" [30, 31, 32] after the example of the USA.

Through these intervention methods a larger number of therapies might be examined, getting preliminary effectiveness data, in order to better orient research and supply preliminary data to seropositive and sick persons in more useful times with respect to their life expectations.

Some proposals and considerations

1) It is necessary to favor the encounter among conventional and unconventional medicines, promoting practitioners collaboration which sometimes clinically follow the same patient.

2) It is necessary to favor the participation of persons with hiv to the realization of experimental designs for drug evaluation, realizing structures of "collective consultation".

3) It is necessary to extend participation to ethical committees to persons with hiv and their communities, to bring the experience of whom is living the disease at first person.

4) It is necessary to promote a serious and real respect of the person's freedom of therapeutic choice, a right that should pass from the formality of documents to the reality of society's medical culture.

5) It is necessary to strenghten the practitioner-patient bond and trust. Practitioner is an inalienable resource for a person, but the person is an individual reality and her autonomous freedom of choice a reality unavoidable to the practitioner. When a disease has not a resolutive therapy yet and there are above all experimental or controlling therapeutic interventions, it becomes essential the relation to get the characteristics of a therapeutical alliance. In alliances there are two active parts and they hold on to recognition and mutual respect.

6) It is necessary that the "informed consent" be not a formal act but an authentic opportunity of information moment, comprehensive of accurate information also on possible alternatives.

7) It is necessary that the informed consent be continuous and not only concerning drugs and experimental treatments but also those already validated, in presence of new researches.

8) It is necessary that Public Institutions allow unconventional therapies researches for hiv and aids, only this way it will be possible to evaluate them realizing a service to citizen, who can choose among different proposals studied at the same level.

9) It is necessary to realize organic collective projects, and if possible institutional, of monitoring and epidemiological research on unconventional therapies.

10) It is necessary that National structures dealing with aids (National AIDS Commission, Council) have inside a representation of persons with hiv associations (and not only of some of them) and of associations of unconventional medicine practitioners. There must be no fear for comparison confront and only by accepting this challenge it is possible to better act in the persons' interest.

11) Activist, operator and practitioner associations for the fight against aids present in Institutional Commissions at national and local level should operate in a spirit of collectivity and service and not use such presence with the purpose to gain power positions in order to facilitate their own association. They should learn the attitude to periodically make a working report, to promptly inform associations on opportunities and on open planning paths; they should use the contribution of all to proceed in their work.

12) It is also necessary to locally organize common working moments among practitioners of different orientation, Institutions, persons with hiv, aids fighting associations and other realities to favor exchange of information, meeting and mutual knowledge, realization of a more learned and homogenous information. This also to supply to the persons with hiv a less conflicting, confuse, uncommunicative information, an ever party information according to the source it belongs to.

 We wish that considerations and initiatives contained in this opened letter may be discussed together. We are available to talk about it frankly with anyone.

Notes

[1] VVAA. Concorde: MRC/ANRS Randomized Double Blind Controlled Trial of Immediate and Deferred Zidovudine in Symptom-free HIV Infection. The Lancet. Vol. 343. April 9th, 1994. Pp. 871-881

[2] Garattini S. A point about Zidovudine. "Ricerca & Pratica" n. 54. 1993

[3] Lenderking W.R. Evaluation of Quality of Life Associated with Zidovudine Treatment in Asymptomatic Human Immunodeficiency Virus Infection. N. Engl. J. Of Med., 1994: 330, 738-743

[4] Declarations elaborated by an interdisciplinary group of researchers, clinicians and members of the associations in Aids and Bioethics, Special Issue H San Raffaele Scientific Institute, Europa Scienze Umane Editrice, 1992, pp. 275-281

[5] Santosuosso Amedeo, Developments of the Right to Health, L' Arco di Giano, N. 4, 1994, pp. 53-73

[6] Amedeo Santosusso, "Decisional Freedom of the Patient and Request of Cure Withdrawal: a Juridical Perspective, in Aids and Bioethics", Special issue Scientific Institute San Raffaele Hospital Europa Scienze Umane Editrice, 1992, pp. 102-114

[7] Eisemberg D et al. "Unconventional Medicine in the United States", The New England Journal of Medicine, Vol. 328 n. 4, 1993, pp. 246-252

[8] Arochne J. "Complementary Therapies. The Frustrated Promise." National Aids Bulletin. May-June 1995, pp. 20-21

[9] Fisher P., Ward A. "Complementary Medicine in Europe", British Medical Journal vol 309- 9 july 1994, pp107-111

[10] National Institutes of Health. Alternative Medicine. Expanding Medical Horizons. A report the NIH Alternative Medical Systems and Practices in the United States, Act by NIH, pp. 372. 1995

[11] National Institutes of Health. The Office of Alternative Medicine. General Information. By NIH 1995.

[12] Deutsche AIDS-Hilfe e V. Unconventionelle Medizin bei HIV und AIDS (Wolfstaedter H.D.). 1995

[13] NAM. Hiv & Aids Treatments Directory. NAM Publication. July 1995

[14] De Franceso et al. Abstract National Conference ANLAIDS - Rome 1-4 december 1995

[15] L.I.L.A. Research on Complementary Therapy on AIDS in Italy. Data not published yet, presented at Press Conference 21-11-945 Milan

[16] Direct evaluation by Poiesis Center of the Exodus Group on persons afferent to their own service

[17] Montagnier L. AIDS The man against the virus. Ed. Giunti 1995

[18] Baker D. Copeland R. Staying Healthy with HIV. A guide to alternative and complementary therapies. Booklet Design & Production Randy Simon. San Francisco 1993

[19] NAM, Immune Development Trust, Directory of complementary and alternative therapies in hiv/aids. NAM Publications Ltd 1994

[20] CFR note 13

[21] Bree Scott-Hartland. Common Alternative Therapies. GMHC Treatment Issue. Vol. 7, N. 11/12. 1994

[22] AIDS project Los Angeles. Treatment Education Program. Volume I. Aids Project Los Angeles 1994

[23] Final motion adopted by the Study Seminary "For a Reasonable Safety Doctrine" participants. Working hypothesis for use and experimentation of complementary therapies for hiv and aids". Bocca di Magra 12-14 May 1995. In printing

[24] Poiesis Center of the Exodus Group, Gruppo Abele, Associazione Solidarietà Aids (ASA), Lega Italiana per La Lotta contro l' AIDS (LILA), Associazione Nazionale Lotta Aids (ALA), Centro Orientamento

Educativo-gruppo Medicina Tradizionale (COE), ARCI Solidarietà, Progetto Iride, Associazione Pantagruel Associazione AlfaOmega, Pensare Positivo di Comunità Nuova.

[25] Presentation of the National Observatory of Complementary Therapies. By associations listed in note 24..

[26] International Organization Council of Medical Sciences. Ethical International Directives for Biomedical Research conducted on human subjects. Geneva 1993. In Social Updatings April 1994

[27] Abrams D.L. Dealing with Alternative Therapies for HIV. In Volberting et al. The Medical Management of AIDS. Ed. Saunders Company 1995

[28] Wolfstaedter H. D. Überlegungen zu einem modernem Konzept komplementärer Therapien bei HIV, in: Jäger H (Hrsg) HIV-Medizin, Möglichketein einer individualisierten Therapie. ECOMED Verl. 1994, 259-267.

[29] Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Products. WORLD HEALTH ORGANIZATION. WHO/TRM/GPA/90.2

[30] Delaney M. et al. Proposal to Speed up Accelerated Approvals, Bulletin of Experimental Treatments for Aids. September 1995. San Francisco

[31] James J. S. AIDS Research Strategy: Small Trials for Promising Treatment Leads, Aids Treatment News n. 201 June 1994

[32] James J. S. HIV-RNA: New Blood Tests for Individualized Therapy and Faster Trials, Aids Treatment news n. 204 August 1994