Declaration of Helsinki redux

The Declaration of Helsinki was revised last week, apparently not to much fanfare. In fact, I could only find two news articles on the web about it (here and here), and Science published a piece about the lingering controversies surrounding the Declaration and its revisions. But other than that, the revised Declaration seems to have generated little interest, excitement or opposition. For those unfamiliar with this document, or the organization that acts as its custodian, the Declaration of Helsinki is a statement of principles concerning medical research with human participants developed by the World Medical Association (WMA). There is nothing particularly Finnish about the Declaration, only the name -- it happened to be where the WMA General Assembly first adopted it in 1964 -- but the name lends the document a certain austere, Nordic and 'internationalist' feel. This is only fitting for a document that is regarded by some as a cornerstone of research ethics with global reach.

Careful and prolonged attention is bestowed to the precise wording of the Declaration, as though the lives of millions depended on each word. So what is new about the revision? Three main changes seem to stand out:

• Registering clinical trials. Paragraph 19 of the revised Declaration states: "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject." Apparently representatives of pharmaceutical companies are unhappy with this new paragraph, because it implies that all phases of clinical trials must be registered, even phase 1 trials. They argue that such registration drives up research costs and because it involves disclosure of what research projects are doing, it could violate intellectual property rights. On the other hand, it is predictable that something would be added to the Declaration about registering clinical trials (without being specific about any phase) after the high-profile injuries to humans involved in the Northwick Park TGN1412 Phase I trial. Nevermind: the pharmaceutical industry will probably just ignor this paragraph anyway.

• The use of placebos in clinical trials. When is it ethically acceptable to have a placebo arm in a clinical trial? Paragraph 32 is meant to deal with this sticky issue, and the answer (to paraphrase) is that a new experimental intervention should be tested against the 'best current proven intervention', except when (a) no current proven intervention exists, or (b) where there are really good scientific reasons to use a placebo and where those who receive the placebo will not be subject to any risk of serious or irreverible harm. The paragraph adds: "Extreme care must be taken to avoid abuse of this option." Reports on the revision suggest that this Paragraph is really restrictive of placebo use -- which some find troubling because it could hamper the progress of science, and others find noble because it protects research participants and does not bow down to pharmaceutical industry interests. Nevermind: FDA recently implemented rules allowing applicants for new drug approvals bypass the Declaration ofHelsinki when conducting certain trials overseas.

• Post-trial benefits. The concern that research participants (particularly those in impoverished countries) ought to get something back from their participation has been growing in reserach ethics circles in recent years. There is a feeling that it is unjust for drugs to be tested on the world's poor, while the benefits of the research mostly accrue to the richer nations -- in short, the poor are good enough to be tested on, but not good enough to have access to the finished product. The new Paragraph 33 reads: "At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care and benefits." For better or for worse, this leaves the question what counts as an 'appropriate benefit' wide open. A research team could say that there were things in a study that the participants got that non-participants didn't get, and that is 'benefit' enough to fulfill the requirements of the Declaration of Helsinki. Nevermind.

We're just here to help: disaster research in developing countries

Disasters are in the first place tragedies: persons are killed, injured and traumatized, and their ways of life may be irrevocably changed. But disasters are not necessarily tragedies for everybody: can also be manipulated to promote someone's interests. This is the central thesis of Naomi Klein's The Shock Doctrine -- natural and non-natural disasters are moments of collective weakness that the rich and powerful exploit to enact dubious policies that they might not otherwise get away with.

A recent opinion in SciDev warns against the potential for disaster research in the developing world to become an example of The Shock Doctrine. While there is obviously nothing intrinsically wrong about doing research in the midst of a disaster -- such research is needed to improve future disaster responses -- there are ways to doing it that threaten to increase the vulnerability of disaster victims. Author Athula Sumathipala speaks from experience:

Because natural disasters are often sudden (like cyclones) research can sometimes start without proper scientific rigour or ethical consideration. Researchers may rush to collect data, without adequate planning.

This can lead to undue pressure to participate, particularly when research is combined with humanitarian aid or clinical care. Some survivors may not even realise they are taking part in research.

In my home country of Sri Lanka, for example, the 2004 tsunami was followed by a huge influx of foreign organisations and individuals offering humanitarian aid, including counselling. Some advocated compulsory counselling for survivors, though this runs against recommendations from the WHO and the Cochrane Collaboration — a not-for-profit organisation that provides information on the effects of health care.

In parallel to these 'services', doctoral students from developed countries acquired data to finish their theses, harassed survivors with numerous questionnaires and even collected blood to research neurobiological stress markers. In the rush to provide assistance, a lack of familiarity with local customs caused cultural insensitivities. For example, many people would prefer to seek help from a temple rather than a therapist.

To counteract the feeding frenzy of 'help' from disaster researchers, Sumathipala promotes the usual sort of things: consultation on the needs and priorities of affected communities, the involvement of ethics review committees, and development of international guidelines specific to this type of research.

The conscientious objector argument in Thailand

A couple of months ago, the 'conscientious objector' argument in medicine made headlines when the US Department of Health and Human Services proposed regulations that aim to protect health professionals who, for reasons of moral or religious conscience, are unwilling to provide certain medical services to patients. As everybody knows, 'certain medical services' is code for abortion, and no topic divides Americans ideologically more effectively than abortion does. 'Pro-choice' advocates argue that the head of Health and Human Services, Mike Leavitt, not so much concerned about 'discrimination' towards health professionals or freedom of conscience. The real concern is on the embryos and fetuses. But between talk about the conscience of the physician and talk about the fetus, something gets left out: namely the woman who is seeking abortion as a (legal) medical service. Proponents of the proposed regulation point out that it does not prohibit women from seeking abortion services; it merely prohibits women requiring the procedure from physicians who have religious or moral objections to it. Among other things, opponents of the regulation say that once you allow for the conscientious objection argument, you will soon have pharmacists refusing to dispense contraception or nurses refusing to recommend the 'morning after' pill. Women's reproductive rights get increasingly hemmed in by the values of social conservatives.

In a paper a couple of years ago, Julian Savulescu wrote a paper about conscientious objectors, in which he looked to make a reductio ad absurdum argument. Imagine, he writes, if a doctor said that he refused to treat patients over the age of 70, because on moral grounds, scarce medical resources could be better invested in the younger population. People would find such an 'act of conscience' appalling. The example suggests that once you allow for the conscientious objector argument, health professionals will be empowered to refuse to treat patients for all sorts of reasons. A weakness of Savulescu's argument, of course, is that it makes use of a thought experiment. There probably is no doctor who actually thinks this way. But there are doctors (nurses, pharmacists) in the world who do think this way about the provision of abortion services.

A better, real-world example of the conscientious objector argument gone awry surfaced last week. Thailand is currently embroiled in serious civil conflict, the culmination of three years of strife between forces for or against ousted Prime Minister Thaksin Shinawatra. The People's Alliance of Democracy (PAD) launched a street campaign in May against the government of Samak Sundaravej that they claim to be a puppet of Thaksin. There have been violent clashes between protesters and the government police, and in solidarity with the protesters, doctors in some hospitals have refused (or threatened to refuse) to treat injured police officers. The police have been using excessive force against protesters, and the physicians are basically claiming that treating injured policemen would be acting against their own moral conscience. Human rights groups have rightly condemned the doctors' action, saying that it is a violation of medical ethics and international humanitarian law, reaffirming that the doctor's primary task is to heal, not to judge.

Bioethics angle to the 'financial downturn'

All major news outlets, as well as the US Presidential candidates, have been focused for the last ten days on the credit crisis that has rocked financial institutions worldwide, and rightly so: it looks as though the world is facing a deep economic recession, if not a full-blown depression. Experts are baffled by the exact causes of the upheaval, and the effectiveness of radical remedies (in the form of multi-billion dollar cash injections to banks) is not yet known.

From a developing world perspective, there is a terrible irony to all this. For decades, developed countries and international financial institutions (like the International Monetary Fund) have preached financial responsibility and restraint to low-resource countries, and complained bitterly about local corruption and mismanagement. Now the shoe is on the other foot, as an unregulated culture of excessive risk-taking and speculation in the world's more affluent countries leads global financial markets to implode.

Unfortunately, those living in low-income countries will probably not have much time to take pleasure in this vivid display of hypocrisy. The financial crisis could very well spread to low-income countries, and affect them disproportionately, since many of such countries were economically fragile already and most are dependent on international loans. Given the known links between economic indicators and health, it seems likely that if the economic crisis spreads, some developing countries may experience greater morbidity and mortality as a result of the irresponsible actions of far-away people from the 'richer North.' That kind of potential harm is rendered invisible by the media, which generally sees 'bad consequences' of the financial meltdown in terms of potential rises in unemployment in North America and Europe, not increased disease and death elsewhere.

Follow up on the ethics of nurse recruitment from developing countries

A couple of posts back, the topic was the launching of a new ethics code, namely the Voluntary Code for the Ethical Recruitment of Foreign-Educated Nurses to the United States. The code is a response to the well-documented 'brain drain' of nurses from developing countries. In that post, I expressed some skepticism in regard to the code's enforceability and potential impact. Given that recruiting foreign-educated is interesting for powerful agencies in the United States from a cost-benefit perspective, why would they sign onto to Code and hold to its guidelines?

In a letter last Sunday to the Washington Post, Samuel Witten, Acting Assistant Secretary of the
Bureau of Population, Refugees and Migration within the US Department of State gives a flavor of the government's view of the Voluntary Code. Witten states that the Voluntary Code has noble ideals and makes some good points. But the point of the letter is to express one basic complaint: according to Witten, the Code " ... discourages U.S. companies from hiring nurses from countries with severe shortages of health workers, implying that a qualified nurse from a developing country has less right to apply for migration than a counterpart in a developed country."

In my reading, the Voluntary Code does not at all deny the right to migration. What it does is embed that right as one consideration among others in a larger context, which also includes the devastating social and health impact of the loss of nurses for developing countries. Its guidelines are the product of careful balancing of divergent concerns and interests. Apparently the US Department of State sees things quite differently: the individual's right to migration is taken to be the chief, overriding consideration in such cases, even when it comes to the poorest countries with the worst nurse/patient ratios.

That standpoint about 'individual rights' is convenient: it maintains the status quo in regard to the brain drain of medical human resources from developing countries to more affluent ones. The US Department of State is apparently much more concerned with US capacity to cheaply meet nursing care demands for its aging population than it is for the fate of health care and health in general in some of the poorest countries in the world. I suppose this is to be expected, but it is depressing nevertheless.

***Many thanks to Kristen Rosengren at AcademyHealth, who alerted me to Witten's letter in the Washington Post. AcademyHealth was one of the agencies involved in the writing of the Voluntary Code and is, as it describes itself, ". . . the professional home for health services researchers, policy analysts, and practitioners, and a leading, non-partisan resource for the best in health research and policy."