The shrinking of Human Rights. The controversial revision of Helsinki’s Declaration

British HIV Association, HIV Medicine (2000) 1, Original Research, pp.1-8

Prof. Mylène Botbol-Baum (Unité d’éthique biomédicale, UCL Louvain, Brussels)

 

Abstract: I will propose a critical reading of the revision of Helsinki’s Declaration from the perspective of the weakening of access to health care for HIV patients in developing countries. The dichotomy between human rights discourse and the internationalisation of liberal public health policy is underlined. I argue that a superposition of principalist and utilitarianist ethics, deprived from a sound notion of distributive justice, creates a discriminative protection of economically vulnerable patients in developing countries.

Keywords: Helsinki revision, human rights, utilitarian ethics, distributive justice, commodification of health.

 

Introduction

We will analyse in this text why the revision of Helsinki’s Declaration, a major code of ethics concerning research with human subjects, is so worrying. This Declaration has been changed several times since the Nuremberg code, and the main argument of the text, until now, was to preserve the prevalence of the interests of the subject over the interests of science and society. The declaration stated that to be ethically justifiable, a clinical research must protect both the rights and the welfare of the participants. It stated that scientific research must serve Healing. The recent tendency of the current draft is to emphasise that research is not health care oriented, but profit oriented. Moreover, health care today is far from being an entitlement in most of the world. In May 1997, the Public Citizen Health Group denounced the unethical clinical trials aiming at investigating ways to reduce perinatal transmission of HIV infection in the developing world:

" Apparently reacting to the fact that perinatal HIV transmission trials, in which drugs of known efficacy were withheld from HIV –positive pregnant women, were in clear violation of the current version of the Declaration, researchers have reacted by seeking to change the ethics rules to comply with the scientific studies they wish to conduct rather than revising their studies to be ethical (…) The proposed Declaration is stunningly complacent. There seems to be no recognition of recent abuses in international research (…) opening the door to unethical research seems to be its primary agenda" 

The Lancet did not have such a critical view and published a consensus statement written by participants at a US conference on research ethics standards. It clearly defended "ethical relativism" that would allow to propose new guidelines justifying double standards principles for research subjects in developing countries.

The NIH clearly did not provide control groups (pregnant HIV-infected mothers) in developing countries with the most effective therapy available. This was judged by many to be unethical, according to Helsinki’s previous declaration (1964). The question was to know whether the randomised placebo-controlled design violates the rights and welfare of participants if they do not satisfy the availability of the treatment (here the ACTG regimen 076). It seems obvious from the start that placebo-controlled trials placed economic goals prior to individual subjects' welfare, a position obviously contrary to the principles defended by Helsinki’s Declaration. We will analyse in this paper why, instead of backing off from research in developing countries, the responsible authors decided to modify the Declaration so as to include arguments that would allow defending the trials.

The 1964 Declaration of Helsinki states that:

" In any medical study every patient, including those of a control group if any, should be assured of the best proven diagnostic and therapeutic method."

The ethical exigency of the 1964 declaration seems "unreasonable" to some pharmaceutical firms and is slowly replaced by the idea that:

" If the people in a developing country assume risks by participating in a biomedical research, but cannot afford the drugs, vaccines, (…) then they may be exploited for the benefit of people in the developed countries that sponsored the research"

This controversy between the duty to provide drugs and the rationality of marketing drugs has been judged to slow down research, but it also generated a reflection on the necessity to rethink the ethical norms governing research. The ethical question remains : in whose interests?

The arguments against the ethical permissibility of clinical trials planned in the developing world.

As Marcia Angell has stated in a famous editorial , Western researchers are violating their duties towards their research subjects on two counts :

1. article 2 of Helsinki’s Declaration: " All research subjects should be assured of the best proven diagnostic and therapeutic method (…)"
   The placebo is therefore unethical since the universal standard of care for HIV patients requires access to AZT, although the actual standard of care in developing countries is "no treatment".
2. Researchers do not respond to the duty to have "an ethical responsibility to provide treatment that conforms to the standard of care in the sponsoring country (…) when possible" (guideline 15, CIOMS)

 

For and against arguments

In the absence of placebo group trials, researchers are unable to demonstrate the vertical HIV transmission rate. The researchers are thus using a sound method of investigation. However, it does not liberate them from the accusation of exploiting the hopes of poor uneducated women to the benefit of more affluent populations, in sponsoring countries (even though victims of the same disease are found in these rich countries). The problem is the absence of the ethical intention, likelihood to provide a cure, or cynical attitude of conducting clinical trials, knowing that it is of no use to the host country.

Apart from the difficulty to establish the limit of the use of placebo-controlled studies, this issue seriously questions the future of international research. Can we legitimate that standards of care diverge among countries, without compromising the scientific justifiability of a study?

Can we pursue clinical trials in countries knowing extreme scarcity? The question now is not to know if a short AZT treatment is "better than nothing", but if the AZT regimen is safe in a context of poverty, when the treatment is abandoned after the trials.

FOR	AGAINST
Public health needs to develop affordable interventions Lack of resources in developing Nations Efficiency of placebo controlled studies	Concern for the welfare of the individual the importance of minimising risk and preventing harm in gaining scientific knowledge Scepticism about the intention of drug companies to support a just distribution of available treatment

 

Double standard regimen?

We are at a turning point in the history of human experimentation, as most critics underline. It seems curious that, at such a critical moment, new guidelines seek to ratify already questionable practices rather than to regulate them.

The modifications seem different if we look at the text from the developed or developing world viewpoint. From a rigorous reading of the 1964 Helsinki’s Declaration, one must be critical of placebo-controlled AZT trials, but many competing theories exist, due to the fact that the line between clinical practice and medical research is becoming more and more difficult to perceive. In this context, the pressure to weaken human subjects’ protection leads to "de-emphasise the principle of consent". Robert Levine insists that therapeutic and non therapeutic research are not applicable categories anymore. This position is not a neutral ethical position; it is in phase with the most prominent on the market today, "the liberal consensus view", stating that:

"Justice is equivalent to the kind and amounts of health care that informed rational individuals would

choose for themselves"

On this ground, he refuses the argument according to which "every patient in every country is entitled to receive the best proven therapy available in industrialised countries, even if such therapy is not available in the country in which the patient resides". This is precisely the argument which led to the questioning of placebo-controlled trials of the short duration regimen, intended for the prevention of perinatal transmission of HIV in developing countries.

We understand better why, since the revision of Helsinki’s Declaration was proposed by the WMA in Chile in April 1999, it has been one of the hottest topics in research ethics. To understand the polemic between the defenders of the revised version of the declaration and its opponents, we must underline the conflicting intentions behind the modifications.

The opposing statements must be confronted in the context of the changing tone of the declaration from principalism to utilitarianism. I will ground my judgement on the search for coherence between the revised articles of the declaration and human rights principles.

I want to underline that the new, longer version of the text does not necessarily mean an enlargement of patients’ protection either in rich or poor countries, but rather a segregation of over-protected versus under-protected patients. I will thus mostly work on the tougher issue of the convention on HIV trials, which addresses most dramatically the question of distributive justice regarding access to health care. The argument according to which duty to give access to health care should be considered on a relative basis, weakens justifications (individual happiness for all) in the revised declaration. This dramatically replaces the universalist tone of the 1964 Declaration.

Moreover, although the new declaration rests on a coexistence of both Kantian (autonomy and universality) and utilitarian (efficiency and benefit over risk) principles, it does not allow the privileged and third world patients’ interests to coexist. This incoherent mixture leaves us with ethically inapplicable regulations of research practice. It leads to a legitimisation of the precedence of research economical efficiency over the ethical intention to reach distributive justice with the product of this research.

The most striking argument, from an ethical perspective, is the cynical justification, in the revised text, of the inapplicability of a universal health care standard to all humans (why then still pretend to work with universal standards?). This idea appears clearly in the precedence of "scientific principles" over "ethically sound research", in the articles 13 to 21 of the declaration. These passages refer essentially to the utilitarian terminology of "balance of risks and benefits", mixed with a pragmatic view of access to health care as a commodity. The universal 1964 Declaration seems now reduced to address able customers only. One realises that the new declaration separates patients into two classes:

1. accepting clinical trials in the name of an altruistic view of scientific research (cf. article 16), and
2. benefiting from the products of this research.

The ethical problem lies in the fact that these two classes are very clearly and hierarchically discriminated, and that no more intention exists to unify their interests because market ethics veils medical ethics. Class (a) becomes the means to an end, the well being of class (b) (what then remains of Kant?).

The notion of informed consent, central to the previous versions, appears here in article 22 only, and the waiver of consent is presented in a sophistic way as a privilege offered to subjects incapable of valid consent. The immediate effect is to justify experimentation as a new privilege for (class (b)) patients entering as partners in a process, with no commitment to respect the vulnerability of (class (a)) patients economically unable to become contractors or clients. The notion of economical vulnerability is avoided in the revised declaration. What is underlined in article 22 in terms of conflict of interest is mainly "financial conflict". This notion appears particularly problematic if the reader recalls that the revision was motivated precisely by the scarcity of treatments available to pregnant mothers in third world countries. They were "offered" trials of zidovudine to prevent the transmission of HIV to their children. The debate turned around the efficiency of research versus the intention to benefit the women and children participating in the study. The revision of the declaration defends the first option without clearly stating it. Nonetheless, in article 18 of the revised declaration one can read: "Every patient-subject should be assured that he or she will not be denied access to the best proven diagnostic (…) if such is justified by a scientifically and ethically sound research protocol". My thesis is that it is no accident if the term "scientifically" is placed, in a syntactical (hierarchical) precedence, before the term "ethically sound", as if ethically sound were determined by the former. Moreover, the US agencies argued in favour of the suspension of funding for such trials in third world countries, on the basis that it was not "scientifically sound". It has become more than a semantic problem. It is an ideological return to the positivist idea that "what is scientifically sound is ethically sound". It rejects by the same token the relativist approach demanded by pluralist ethics. But the rhetorical effect does not stop there, since the so called "consensus statement" (in the Lancet, cf. supra) supported relativism in determining the standard of care, forgetting that distributive justice requires that the subjects of trials benefit also from the research findings. We see that the ethical terms are used out of their frame of reference, as mere rhetorical tools.

Robert Levine, who advised the US government on the issue of the modification necessity, justified the revision by a pragmatic argument: "Article II, 3 was much too universalistic, it would not take into account the "reasonably available" to the residents of the host countries (…) The O76 regimen cannot be made available to residents of developing countries on a continuous basis". If this is certainly an argument defensible in terms of efficiency and rationality, we are witnessing a shift from a principalist to a utilitarian declaration by an inadequate use of principles. The paradoxical fact is that the more research is internationalised, the more a relativisation of ethical principles is proposed to justify efficiency. The moral duty to subjects has become a paternalistic accessory which, in the name of progressive ethics, is emptied of its ethical meaning. I will try to illustrate why these semantic changes are not acceptable, even in the language game of pragmatism. The strategy of opposing rationality to the idealism of universalist ethical principles is not new and is easily identifiable in terms of political discourse. My argument in this paper is that, if we accept these premises, we lose any chance to reach a shareable ethics in terms of responsibility toward all human subjects. Global responsibility should be argued in terms of obligation, accepted as the condition of freedom for all . Would the revision of the declaration lead us to submit to the fact of existing second and third class patients, in the name of pluralism and relativistic ethics?

The difficulty in treating such issues is that it involves a decoding of the socio-political options, behind the arguments and their economical impacts. Ethics, like any sound intellectual reasoning, implies the choice of a set of rules, which must be followed within one context until the end of the argument. The revision of the declaration, on the contrary, mixes the contexts of two sets of rules, according to what best suits its interests. Health policies, used to argue Jonathan Mann, have a potential to weaken human rights, to a greater or lesser degree, discriminating against individuals or population groups. However, not considering the human rights dimension of health policies makes the policy ineffective, or even detrimental, not only to the discriminated group, but to human rights in general. The conflict of interpretation provoked by the declaration modification, clearly underlines that Public Health benefits in the US are not in balance with global human rights duties.

 

The main proposed modifications and their interpretation

The main modification proposals can be summarised as follows:

1. To waive the distinction between therapeutic and non therapeutic research.
2. To question some provisions "out of touch with contemporary ethics: "reset involving children, for a non-therapeutic procedure", assuring the best therapeutic method, forbidding placebo control" (R.Levine). These protective provisions are considered inadequate and overprotective for autonomous patients, who volunteer to assume reasonable risks.

Again, whose interests are defended by such modifications? The interest of the 2 millions HIV victims dying each year? Six millions South Africans infected with HIV by 2005?

The concept of vulnerability not only concerns the disease but also:

1. personal factors,
2. factors of quality and quantity of health coverage,
3. socio-political factors

My main request is that the Helsinki’s Declaration be a responsibility statement of developed countries toward developing countries, rather than a false promise of freedom for all ignoring the economical vulnerability of experimentation subjects. The modifications render the text discriminative since the target population is specific and not universal anymore. It should be clear to all that if the epidemic is not addressed at a global level, no durable cure is possible for anyone. We are condemned to be generous with HIV therapies. The orientations of research toward a global vaccine, or specific therapy, certainly generates a socio-ethical effect, but only if it is patient-oriented. Within present market ethics, the interests of all are better served only when providers compete and consumers are free and economically able to choose. But what happens if we apply this utilitarian rationality to the HIV issue?

 

The shrinking of Universal into National principles?

The previous ethical problem was solved when some leading companies in AIDS research initiated work on DNA vaccines, and discovered the HIV genetic specificity. Their findings appeared to discourage their interest for research on a "universal vaccine", and consequently to stop the trials in developing countries.

The stopping of the trials was justified by the argument that the standard care had now to be evaluated relatively to the local standards and not absolutely in terms of universal standards. This relativisation of ethical principles was justified and confirmed "ethically" by a consensus statement from developed countries, raising the threat of eugenicist standards of health.

In the Gottingen paper, resulting from the symposium in Germany to discuss the revisions, article 8 mentions:

"The problem of an impossible " ethical export ", i.e. the conducting of biomedical research abroad (in particular in developing countries) in order to avoid difficulties at home and/or to lower costs, should be addressed by the declaration".

This impossibility is an ethical necessity nonetheless, not addressed properly in the revised version. Utilitarianism is a deterministic moral theory that relies on empirical matters to arrive at a practical solution. The revised version is certainly less idealistic in terms of distributive justice and more practical about solutions. It implies that applied ethics must be realistic and not merely a gatekeeper preserving coherence between traditional principles and scientific facts. But must we surrender to such a deterministic view of applied ethics when it endangers our ideal of human rights?

This proceduralisation of ethics might encourage a comfortable bad-faith attitude towards what is considered as " the most important document of professional rule for medical research on human beings".

Jonathan Mann insisted on a modern concept of Health that would embrace "the broader societal dimensions and context of individual and population well-being". With him, I believe that the issues of public health and human rights are articulated and inseparable.

The polemic over the revised declaration is about the ethicity of double standards of quality of care, that would conflict with what we consider to be the universality of human rights. The issue of the link between human rights and bioethics is not an idealistic viewpoint anymore. It is even perhaps the most lucid perspective on coherent bioethics, linking the autonomy and the vulnerability principles.

"Global thinking and visionary actions specific for particular societies are the seeds for initiative and propagating qualitative and quantitative changes that could have major long term advantages for humankind"

This is a resistance statement in a world where it has been said: "…two thirds of all the people on the planet are superfluous from the perspective of the market. By and large we do not need what they have; they can’t buy what we sell. This market-driven ideology infected health care. We know that one of the major dilemmas of contemporary medicine has been that experimentation on human subjects is essential to the economical promotion of scientific progress but not necessarily to the promotion of personal well being".

The basic solution is not to shrink the principle of informed consent, but rather to enlarge its application beyond the limits of autonomy, to pregnant women, infants, the poor. Raising the question of uneven distribution of risks among various segments of the world population will temper the hopes of making of research protocols, liberated from the ethical constraints, the tool of liberation from suffering. When "democratic institutions" leave to the poor to assume the risks only, while the rich and the privileged enjoy all the benefits, we must denounce the distortion of principles, disconnected from their frame of universality which alone gave them a consistency.

 

Individual and public interests

"The more devastating the disease and less satisfactory the existing therapy, the stronger the disincentive for a patient to enrol in a randomised trial, if the drug can be obtained in another way. Consequently, a national policy of early widespread availability of unproved experimental agents would slow or even halt the completion of controlled clinical trials which therapeutic advances are established and then improved on."

There is a subtle exploitation of the tension in utilitarian ethics between an individual happiness and the maximisation of common good. Everyone knows it is still a faraway utopia. The trick is that the new version of the declaration pretends to go beyond the old frame of paternalism to embrace fully the frame of autonomy. It presents the public interests frame as a limit of this autonomy, and the right to participate in clinical trials as an enlargement of human rights. It promises to reintegrate the HIV-infected pariah in the human family, not saying that this language game of fusion of models is only possible if the solidarity principle is respected. This superposition of conflicting language games of principalist versus utilitarian principles transform the ethical intention of the new declaration in an instrument of bad faith for the most vulnerable.

AIDS patients in developed countries, because they are protected by strict principles, can afford to transgress the minimal risks principle and force their participation in advanced clinical trials. However, it does not legitimate pharmaceutical firms to impose these risks on vulnerable populations.

The reader must recall here that although, as Levine underlines it rightly, "research has changed drastically, largely as a consequence of AIDS activists", clinical research is not benign, nor beneficial, for all human subjects. There must be a responsibility towards all populations to get access not to experimentation alone but to treatment as well, or at least to the right to produce themselves a replica of the trial drug (like AZT, as it was successfully tried in India and subsequently interrupted for legal infringement). The dilemma is thus not to allow them to participate or not in therapeutic research, but to recognise the ethical responsibility of democracies not to exclude them from the universal category of human subjects on economical grounds.

 

Therapeutic versus non therapeutic

The removal of the distinction between therapeutic and non therapeutic research, because of a conviction that "there is no distinction between medical research combined with clinical research, and non therapeutic biomedical research involving human subjects", is ethically questionable.

The term compassionate therapy is hidden behind the veil of ignorance of utilitarian liberalism.

As for bioethical principles, of autonomy, beneficence, non-maleficence, and justice, it will suffice to compare a defence of the modification by Levine, from a North American perspective, with the denunciation by his colleagues from Thailand or Brazil revealing his individualistic and relativistic approach.

Can research on a universal AIDS vaccine be the solution?

On January 20, 2000, the United Nations Foundations Unwire published the following communiqué:

"Despite low interest by the public, challenges involving a vaccine are numerous, ranging from scientific to the social, ethical and political view. Berkley’s social venture capitalism approach, in which IAVI invests research money in exchange for a guarantee that a successful vaccine would be distributed inexpensively in developing countries, may have created a "new model for poor country assistance". The benefactors being Bill and Melinda Gates, should we be sceptical of this new form of philanthropy mixing Mandela and Bill Gates?"

The most pragmatic questions is now: where should the vaccines be tested first?

For the time being, scientific discoveries are creating a climate of cautious optimism. The chimpanzee is the only non-human species that can be reliably infected with HIV. But the notion of human experimentation has become more complex as well. The diversity of HIV infections presents also another obstacle to vaccine development. Beyond their world-wide division in M and O classes, about ten subtypes have already been identified.

Most importantly, the types prevalent in the developing world are different from those found in developed nations. The novel approach called "naked DNA vaccine", which involves injecting DNA into animals and then using the animal cellular machinery to produce a specific immune response, seems to be the main chosen road, without any ethical reflection acting on this research to defend the principle of precaution.

 

Beyond the commodification of health care

On the market place, the distribution principle reads "to each according to the amount he/she is willing to pay for the goods", without any interest in how the goods are socially determining. The incoherent mixture of utilitarianist and principalist ethics makes the ethics of research unable to resist the pragmatic pressure of economical issues. These orient the choices towards the principles of utilitarianism rather than to those of human rights, since they respond better to the notion of cost-effectiveness. But it would be a methodology error not to underline the antinomy of utilitarianism, which defends both individual happiness and the search for a common good. A sound utilitarianism insists on the tension between the two projects. The danger of the revised version of the declaration is that it gives the false impression to reconcile the search for individual autonomy and universalist human rights principles. They remain incompatible for the majority of the human subjects the text is supposed to protect. The declaration cannot allow a sophist use of principles, turned inside out as gloves by a utilitarianist liberal medicine, more and more alienated to market interests rather than concerned with human interests. As inheritors of the human rights declaration, we cannot allow these principles to be the cache sexe of the end of distributive justice. If the principalism of the 1964 declaration needs some adaptation, it cannot become a text that will recreate second class human subjects, with second class human rights. There can only be losers at this discrimination game. The principle of common good cannot be constructed on the elegant sacrifice of some individuals: the others. We are condemned to the freedom of reconstructing an ethical coherence between pragmatic and principalist ethics, if we do not want procedural ethics to become the rhetoric tool of the legitimisation of injustice.

The alternative would be to reintroduce the notion of justice in the research debate, dominated more by pharmaceutical company sponsorship than by a coherent ethical policy of states solidarity. The multinational pharmaceutical sponsorship should share the responsibility of reconstructing a fair link between society and health, beyond national boundaries. Health care cannot be reduced to a commodity, or it will distort the purpose of the declaration beyond acceptable coherence.