Fake drugs, fake diseases

This week's news included two trends in drug promotion and sales, both of which are detrimental to health worldwide: the advertizing and selling pharmaceutical drugs for phony diseases, and the selling of fake drugs for real diseases.

The corporate-sponsored creation of disease, or at least the widening of the boundaries of disease for marketing purposes, is called 'disease mongering.' From a purely business point of view, it would be a pity if human beings suffered from a finite number of well-defined diseases. It is far better, in terms of pursuing profits, if new diseases would crop up regularly that would create new patient populations willing to purchase new medical treatments. So there is a standing motivation for pharmaceutical companies invent new health conditions or medicalize mildly negative aspects of life that -- while annoying -- were never thought to be in need of drug treatment: such as 'restless leg syndrome', 'female sexual dysfunction' or 'irritable bowel syndrome.' PLoS Medicine put out a series of articles in 2006, and this week has followed up with an opinion piece that reports on the increasing media and academic attention to the phenomenon of disease mongering. Disease mongering must be real: it has its own Wikipedia entry.

What's wrong about disease mongering? The ethics of disease mongering are still a work in progress, but some things come to mind. It does involve exploitation of people's anxieties and fears about their bodies, needlessly making persons into patients, and in this way contributing to human misery -- though misery-creation is not unique to disease mongering. But the greatest harm in disease mongering may come from its distortion of public health priorities: while attention and money is drawn to new treatments for the diseases du jour, other more serious (but less marketable) diseases and essential medicines may be neglected, and this corporate-driven distraction could negatively impact on individual and population health. The problem is not at all restricted to the richer countries, inundated as they are by erectile dysfunction commercials and spam. Asia, in particular, is a vast new opportunity to get people to pay for medications to treat all sorts of newly constructed ailments.

The market in fake drugs, for real and serious diseases, has been a concern for some time. Malaria is not like 'restless leg syndrome': its credentials as an actual disease are clear, and millions die from it every year. In PLoS One, a study has been published that offers a few disheartening numbers. Researchers visited pharmacies in urban and peri-urban areas of six African cities, bought anti-malarial drugs, and tested their quality. The result: 35% failed tests whose purpose was to detect the appropriate active ingredient, and 33% of the drugs were artemisinin monotherapies, i.e. the kind of anti-malarial drug that the World Health Organization thinks should be withdrawn from the market because they create drug resistance. Here is a situation that seriously threatens patient safety and public health, particularly in developing countries. And malaria is just one disease targetted by the counterfeit drug trade: HIV and tuberculosis are others. Counterfeit drug makers and suppliers should be condemned, because they prey cruelly on the poor. Like corporate disease mongers, they are driven by the profit motive, come what may. But unlike them, they at least seem to have a sense of the pressing health needs of communities. Not that this does those communities much good.

Access to real medicines for real diseases: is this really too much to ask?

The dignity of stupidity

It seems that the biggest bioethics news of the week has to do with two concepts that look funny together: dignity and stupidity. Steven Pinker has written a rather brittle essay -- entitled 'The Stupidity of Dignity' -- in response to the recent publication of a report by the President's Council on Bioethics, Human Dignity and Bioethics. For those who keep track of such things, Ruth Macklin wrote an article about five years back with the catchy title 'Is dignity a useless concept?', and she answered her own question in the affirmative, arguing that the term is religious in origin, has no real place in bioethics and should be replaced without remainder by the secular concepts of autonomy and respect for persons. Human Dignity and Bioethics is a 555-page rejoinder to Macklin's challenge. According to Pinker, it is a lousy rejoinder: the report, by dredging up concepts of dignity that are fuzzy or contradictory, has failed to show that dignity is of much use to bioethics.

If Pinker just stuck to that, pointing out the lack of progress with conceptual clarity in regard to 'dignity', his essay would have raised few eyebrows. But Pinker goes on to argue, in effect, that while dignity is a useless concept for analysis of bioethical issues, over the last years it has proved a very useful tool for religious conservatives (including members of the President's Council on Bioethics) seeking to influence political leaders on matters concerning science, technology and human values. In fact, most of Pinker's essay is a kind of potted and impressionistic sociology of the conservative origins and tendencies of the Council, rather than a sustained analysis of what is actually said in their report, though he does pick out a few choice gems for comic relief. Leon Kass, the bioethicist in America closest to the ear of President Bush, comes off as someone whose intense concern for dignity casts doubt on his overall mental health: the man vigorously opposed to IVF turns out to be equally opposed to the (undignified) practice of eating ice cream in public. Imagine, if you will, a group of like-minded moral hypochondriacs imposing their religiously-fueled vision on the rest of society, beating down opponents with resonant (but actually empty) appeals to 'human dignity'. You get Pinker's drift: lovers of human dignity may end up being enemies of human freedom, and when push comes to shove, he will take freedom.

The best parts of Pinker's essay are not about the Council, but his views about the limitations of the concept of dignity: it is relative, it is fungible and it can be dangerous. Unfortunately, Pinker does not draw out more the profound implications, and make the chickens come to roost. Are the 'secular' notions of autonomy and respect for persons in any better conceptual shape than dignity is? What do we mean by autonomy, and how is it immune to being relative, fungible and potentially dangerous? (Those who think this concept is obvious or innocuous should read 2000 years worth of moral philosophy.) Ditto for 'respect for persons'. The bottom line is that when we look at the most fundamental concepts that we use in bioethics, we go from applied ethics to metaethics, and from slogans to philosophy, we reach a place where words can falter, and where everyone is vulnerable to looking a bit stupid.

How does this connect to bioethics in a global context? As discussions about bioethical issues become more frequent and explicit around the globe, there are likely to be conflicts between secularism and religion, modernity and tradition. Each culture will struggle to negotiate ways of reconciling new medical technologies and practices with deep-seated values and customs. This will be messy. But one hopes that these tricky negotiations will not replicate the style and tenor of contemporary American bioethics, marked as it often is (from all sides) with excursions into mudslinging, ad hominem arguments and heaping helpings of contempt. Always engage with others as if they are acting in good faith after serious reflection: a good working principle for bioethics, expressing humility and generosity of spirit, but very difficult to follow.

New global health exhibit at the National Library of Medicine

The National Library of Medicine -- the world's largest medical library -- has launched an exhibit on global health at the National Institutes of Health in Bethesda, Maryland. The exhibit, entitled Against the Odds: Making a Difference in Global Health, is devoted to raising awareness about challenges to human health and human rights in an increasingly interconnected (and in many ways, unstable) world. I have not seen the exhibit, but NLM has put out a very impressive exhibit website that provides a wealth of information about the history of the concept of 'global health', the myriad challenges posed to health around our planet, some of global health's (sung and unsung) heros, educational resources and opportunities for advocacy and commentary. If the website is any indication, it looks well worth a visit.

If you work in global health -- or 'global bioethics' for that matter -- you can lose your faith in its mission from time to time. Partly because the problems seem so overwhelming, too big to tackle in one short lifetime, as one small individual. Partly because when global health is made fashionable, strange things happen, such as students from rich universities streaming down to 'help' poorer countries in ways indistinguishable from global tourism. Partly because big funding institutions putting god-knows-how-much-money into god-knows-what-sort-of-project. Partly because trying improve health in an ethically responsible way, in contexts of gross inequality and injustice, can leave you with dirty hands and a bad taste in your mouth. Exhibits such as the one at NLM are largely aimed at the general public, but for those working in the field, it can have other functions: an opportunity to remember the original ethical vision of global health, transcend cynicism and renew old vows.

The FDA ditches the Declaration of Helsinki

As it has been threatening to do for years, the Food and Drug Administration in the United States has finally abandoned the Declaration of Helsinki as ethical standard to be used when evaluating data from clinical trials conducted abroad. But let us back up. Getting FDA-approval for a new tested drug is a big deal: you can make big money this way. But to do research in the United States on a new drug, you first have to submit an application for an investigational new drug (or IND). You can get around this by conducting your clinical trial outside US soil, and then seek FDA approval for the tested drug by submitting a new drug application (or NDA). Up to now, the FDA required that studies submitted in support for an NDA should have been conducted in a manner consistent with either with the Declaration of Helsinki or local laws, whichever is more protective of the participants in the trial. Now the FDA has changed that requirement: it is now enough that the foreign-based trial be conducted according to the Good Clinical Practices (GCP) of the International Conference on Harmonization.

So what is the difference? Someone with a stronger stomach than my own could go through the Declaration of Helsinki and GCP point by point, and try to discern every little ethical difference. Or look at the Federal Register, and evaluate the myriad justifications made by the FDA in favor of the change. For those unable, unwilling or uninterested in going through this regulatory potpourri, let me cut to the chase: the GCP overall is less ethically demanding than the Declaration of Helsinki, and thus encourages the outsourcing of clinical trials in developing countries in a regulatory atmosphere more supportive of pharmaceutical interests than protective of research participants or communities. As some commentators have pointed out, the FDA (and the pharmaceutical companies with whom it often shares beds) was never enamoured of the section in the Declaration of Helsinki that stated that a new drug should be 'tested against the best current prophylactic, diagnostic and therapeutic method', since that would limit the possibility for placebo-controlled trials. That is why GCP is apparently more attractive to them: it does not have any such requirement. Not only that: the GCP does not (unlike the Declaration of Helsinki) contain anything about conflicts of interest, the need to publish results, or post-trial availability of the tested drug to study participants or communities. In the end, GCP is ethics-lite.

The Declaration of Helsinki has its own problems, not the least of which are problems of ambiguity in its language and limited enforceability. But even its most uncharitable critic can see that the document has an ethical backbone. What impact the FDA's decision will have on clinical trials around the world remains to be seen, but the decision would seem to encourage pharmaceutical companies to cut ethical corners when working abroad.