Wednesday, September 21, 2005

What the world needs now: another bioethics declaration

This June, UNESCO unveiled a Universal Draft Declaration on Bioethics and Human Rights. The two central objectives of the Declaration are: (1) to state universal principles that lay a foundation for humanity’s response to dilemmas raised by science and technology, and (2) to ground these universal principles in human rights law in order guide states in the formulation of national legislation and policies in bioethics. Despite these lofty aims, the publication of the draft Declaration seemed to go unnoticed in bioethics circles. Perhaps this is to be expected: no one expects universal truths during summer vacation.

But the bioethicists are back from the beach, and some are less than thrilled with what UNESCO has produced. This month’s issue of Developing World Bioethics is devoted, in its entirety, to an examination of the draft Declaration and to speak of a ‘mixed review’ might be a bit charitable. The editorial draws first blood by calling the Declaration an obvious attempt on the part of UNESCO to muscle in on the authority of the World Health Organization on issues pertaining to the ethical regulation of biomedical research. UNESCO, writes the editorial, is an organization with little credibility among in the wider bioethics community and is best known for holding ineffectual (but costly) meetings and producing colorful booklets. Given its weak track record and dubious expertise, the predictable result is a Declaration that fails to state universal principles, redundantly lifts phrases from existing documents, is out of touch with some current bioethics debates, and offers misleading points of ‘guidance’. One thing is sure: Article 10 of the draft Declaration is a truly devastating piece of bioethics parody. “The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably.” The deadly serious tone makes it all the more amusing.

The Declaration does not fare much better among some of the contributors to the September issue. David Benatar wonders out loud if the draft Declaration, should it be made official, would itself have a favorable risk/benefit ratio: will it do the world more good than harm? Matti Hayry and Tuija Takala ask why the concept of ‘dignity’ is repeatedly and uncritically used in the draft Declaration, despite recent concerns that the concept has no clear meaning. According to John Williams of the World Medical Association, the draft Declaration fails in both of its major objectives: it neither offers clear or helpful ethical guidance nor does it have the power to place new obligations on states. Commentators elsewhere echo these objections and concerns.

Other contributors are more positive. Loretta Kopelman is encouraged by elements in the Declaration that can counter ethical relativism and its negative effects on women and vulnerable populations worldwide. Ruth Macklin finds merit in the draft Declaration’s incorporation of considerations such as benefit sharing in research and the requirement that each country conduct ethical review of biomedical research within its own borders. So it looks like there will be a Universal Declaration on Bioethics and Human Rights, like it or not, and whether the world needs it or not.

Wednesday, September 07, 2005

Ethics and the global trade in counterfeit drugs

A few years ago, on a market in Cape Town, I bought a knitted hat with ‘Nike’ and the famous swoosh weaved into it with gold thread. The local vendor had made these hats entirely himself. A form of innocent theft: if a man can eke out a living by using the brand of a multinational infamous for its exploitive labor practices, well, so be it.

Hats are one thing, medicines are another. The production and sales of fake medications have been booming for some time in the developing world. In many parts of Francophone Africa, they are routinely sold at pharmacies par terre (roadside drugstores) by self-proclaimed pharmacists or docteurs de rues (street doctors). Much of what they sell are counterfeit medicines made to look convincingly like drug products of major pharmaceutical companies: from the packaging to the hologram to the imprint on the pills themselves. But these fakes may contain a reduced amount of the active ingredient, none of the active ingredient or substances that may be positively toxic. An estimated 120,000 Chinese patients are reported to have died from consuming counterfeit drugs in 2001, and some 500 patients (mostly children) in Haiti, Argentina, Bangladesh, India and Nigeria died when their fake paracetamol syrup turned out to contain diethylene glycol. When you realize there is a powerful underground industry and flourishing market for ersatz drugs ‘treating’ some of the major causes of global mortality -- tuberculosis, malaria and HIV/AIDS – you get a sense for the potential public health consequences of the trade.

The scale of the problem is staggering: in a recent article, it is estimated that 15% of all medicinal drugs sold worldwide are fake, and in parts of Africa the figure exceeds 50%. And this is a truly global issue: in a recent book (Dangerous Doses: How Counterfeiters are Contaminating America’s Drug Supply), Katherine Eban describes in detail the increasing difficulties US authorities have in keeping phony drugs out of American medicine cabinets.

As far as evaluating the trade in fake drugs goes, this is an ethical no-brainer: those who produce and knowingly distribute them to unwitting patients are simply immoral and criminal. The real ethical questions concern who is responsible for the enabling conditions of the trade, and who is responsible for doing something about it. Pharmaceutical companies are not just victims here. When the price of legitimate medications essential to health lies outside the financial means of a good percentage of the world’s sick, it is hardly surprising that a market exists for cheap substitutes. Pharmaceutical companies also have typically not taken an active, public role in the investigation of counterfeits of their own products. Fearing loss of consumer confidence in their brand, loss of commercial advantage and falling stock prices, they tend to conduct secretive internal inquiries instead of notifying the public about potential dangers. The companies also are reluctant to cooperate with bodies such as the World Health Organization. Unsurprisingly, governments have historically taken the side of the pharmaceutical firms on this matter. But the only ones to profit from this atmosphere of secrecy, mutual suspicion and narrow self-interest may be the manufacturers and distributors of counterfeit medications themselves.

Tuesday, September 06, 2005

Hurricane Katrina and global bioethics

Johathan Moreno has written an interesting piece on how reflection on Hurricane Katrina could change the face of mainstream bioethics. The hurricane, according to Moreno, has made brutally explicit important connections between public health, poverty, and environmental values that have often remained invisible within a 'bioethics by privileged for the privileged'.

Time will tell whether Hurricane Katrina will have a progressive effect on bioethicists. But how could it without a political conversion towards a social justice-based bioethics that focuses on the power arrangements that make (and keep) the poor sick and vulnerable in New Orleans, New South Wales and New Delhi?