Summer hiatus

For the next month, I can't guarantee much in the way of new posts: the next two weeks I will be in France, without the laptop or internet connection, i.e. the new definition of 'vacation.' Right after that, I will be in South Africa, where I have the privilege of helping teach within the International Research Ethics Network for Southern Africa (IRENSA) program at the University of Cape Town. After a couple of days in Johannesburg, I head up to Kinshasa, Democratic Republic of Congo, to look in at our project 'Building bioethics capacity and justice in health' at the Kinshasa School of Public Health.

Update, July 11th: back in circulation. The visa for entry into the Democratic Republic of Congo only arrived at my hotel in Johanneburg 12 hours prior to my flight to Kinshasa. The Embassy of the DR Congo in Pretoria moves in mysterious ways, including not picking up the phone. And now Kinshasa. Dry, clear skies, dust. But too much army and police in the streets for anyone's good, after a member of the political opposition was gunned down in the street a couple days ago.

Exaggerating the global AIDS epidemic: effect on Africa

Most bioethics scandals, no matter how harmful and shameful, are on a relatively small scale. They may involve a few hundred research participants, like Tuskegee. Or an individual participant, like the Jesse Gelsinger case. Or an individual researcher, like the multiple failures of the cloning Dr. Hwang. But what of a bioethics scandal that operates for decades, affecting the lives of hundreds of thousands of people, maybe more? And one in which researchers, funding agencies, drug companies and pop stars profitted at the expense of ordinary citizens? That would be an enormous scoop.

Increasingly, people are starting to think of the HIV/AIDS epidemic and/or our response to it in these unflattering terms. There are, of course, those who do not think there is such a thing as HIV or AIDS, and that the virus is really a creation of pharmaceutical companies wanting to sell their newest antiretroviral drugs, i.e. disease mongering on a massive scale. These are extreme and minority views. But there is a new wave of criticism of HIV/AIDS policy, research and practice that seems to be gaining strength. One part of the criticism has to do with epidemiology: it is increasingly claimed that projections of the HIV epidemic in Russia and India were far off, so far off in fact that estimates of new infections had to be reduced by the millions, leading observers to wonder if the numbers had been inflated to justify the funding of HIV/AIDS programs. Which leads to another criticism of HIV/AIDS as a global industry all its own, whose activities may be shaped more by politics and vested interests than disease prevention and treatment. It is not just the well-known objections to abstinence programs; it also has to do with HIV/AIDS educational projects in countries where there is low-HIV incidence and no real threat of a hetrosexual epidemic. If you are looking for a big bang for your health buck, the money might better be spent on high HIV-risk groups, or more radically, on other non-HIV related health interventions like clean water projects, family planning or food security. If, over the years, good money was thrown after bad in HIV/AIDS projects worldwide, and human resources were diverted to no useful purpose, this is unethical. The World Health Organization is not quite admitting this has happened, but by admitting that there is no threat of a global hetrosexual epidemic, they will allow skeptics to draw all kinds of conclusions, and raise them loudly.

But those who point out the excesses and waste of the 'AIDS industry' have to be careful not to use language that marginalizes those living with HIV/AIDS in sub-Saharan Africa. For even if policies do not always reflect the epidemiology, more than 2 million people are newly infected with HIV in this region, and at best a third of those who need AIDS treatment have access to it. Millions continue to die due to HIV/AIDS-related causes. The recent criticism is mostly about exaggerated claims of a global hetrosexual HIV epidemic, but the threat is that the reality of the epidemic in sub-Saharan Africa could be forgotten in a fog of bad press. And if the future is like the past, African lives are easily forgotten.

Exploitation in drug safety trials

The New England Journal of Medicine, amazingly, has published a piece on research ethics that you can access online for free. And it is a worthwhile article too: in Exploiting a Research Underclass in Phase 1 Clinical Trials, Carl Elliot and Roberto Abadie describe the basic conditions of those who sign up for safety trials on new drugs, and the analogies with sweatshop labor is never far away. Elliot and Abadie argue that participants in such trials are exploited for three reasons: they are unlikely to gain access to the drugs that are being tested on them, there is little effective regulatory oversight of the clinical drug trial industry, and there is little to no compensation for research-related injuries. In short, it is a bad job, disproportionately done by the poor. Yes, like the positions on offer at the meat-packing plant, you do get money for it. Yes, it is a step up from unemployment and/or living in cardboard box. Yes, you could always argue that this is not exploitation, but merely a fair exchange: the research participant offers his or her body to test drug effects, and gets cash in return. There is no shortage of complex arguments in bioethics that end up defending the status quo in this area. But Elliot and Abadie will have none of it: if participants in phase 1 clinical trials are 'drug tasters' for the more affluent, exposed to the prospect of uncompensated injury and buried far beneath the radar of regulators, that is not a 'negotiating position' for a fair trade of services -- it is a rotten place to be.

The article is a reminder that there are populations in affluent industrial nations analogous to those in the developing world, and equally vulnerable to the corporate model of clinical trial research. It is not that we can do without drug safety trials involving human beings: we can't. But as long as phase 1 clinical trials round up the usual suspects as participants -- low income, without health insurance, immigrants (documented or not) -- the accusations of exploitation will not, and should not, go away.