The death of babies in Indian clinical trials

About a week ago, the London Times Online broke a story about the deaths of 49 infants in clinical trials conducted at the All India Institute of Medical Sciences (AIIMS). Worse, the sad information was not volunteered by researchers or regulatory agencies; it was dug up by a non-governmental organization operating under India's freedom of information act. Accusations of 'using infants as guinea pigs' and unfairly targetting the vulnerable poor swiftly followed. Calls for official investigations. Editorial and commentaries. Spirited defences of the study from the research institution. In short: all the trapping of a research ethics scandal.

With these sorts of things, it is generally wise to wait for the smoke to clear, at least for those of us with the luxury of time. Those scandalized by or merely interested in such cases typically do not have the research protocol in hand, nor background information about how the protocols were followed (or not) in actual practice. In the case of the studies at AIIMS, it is not clear from media reports what the research questions of the clinical trial were or which drugs were given to the babies. Nevertheless, there are some recurring pieces of information that are worth noting:

• The infants in the trials were less than a year old.


• The infants had pre-existing medical conditions, i.e. were suffering from sepsis or respiratory failure (and were placed on ventilators).


• The parents of the infants were generally poor and illiterate.

The AIIMS defends the trials by claiming that none of the infants died from the administration of trial drugs, and that all of the studies were approved by a competent and independent ethics committee. This is good to know, if true. But the more important ethical questions are: do these studies stand to benefit children in general? Could the children in the trial benefit from participation in some way or was it purely 'non-therapeutic' research? What was the scientific justification of recruiting this particularly vulnerable population? Were the parents of these children, dependent on AIIMS for low-cost care, really in a position to give informed consent for their children to participate in research? On the surface, the studies sound like an ethical hot potato, but only time will tell just how hot they are.

When AIDS activists get ugly

According to Wikipedia, "activism can be described as intentional action to bring about social or political change. This action is in support of, or opposition to, one side of an often controversial argument." In the global struggle against HIV/AIDS, activists have contributed positively in an number of ways, particularly in securing greater access to antiretroviral drugs for resource-poor countries and increased funding for HIV-related research and programs.

AIDS activists share common aims, but recent developments make it clear that there are profound disagreements within the activist community on methods and convictions. In the Autumn issue of the Southern African Journal of HIV Medicine (summary available here), AIDS activists Nathan Greffen and Gregg Gonsalves take dead aim at the words and actions of the well-known French AIDS activist organization ACT UP-Paris. According to Geffen and Gonsalves, ACT-UP Paris over the past years has displayed a pattern of irrational behavior, very publicly accusing researchers and research institutions of unethical behavior with little or no factual basis for their claims. One example they give is ACT-UP Paris' spectacular trashing of the Gilead exhibit at the 2004 International AIDS conference in Bangkok, which was supposed to protest trials of pre-exposure prophylaxis with the drug tenofovir among sex workers in Cambodia. Gilead, the pharmaceutical company that produces tenofovir, were not even involved in the study. Months later, ACT-UP Paris were instrumental in shutting down a tenofovir trial in Cameroon, mostly by whipping up a broth of accusation, innuendo and rumor. Much smoke, little fire: no one as of yet has been able to spell out what exactly was so ethically egregious about the Cameroon study.

Geffen and Gonsalves give a number of other examples, but they all make the same point: ACT-UP Paris has been pointing fingers at HIV/AIDS clinical trials and particular approaches to HIV prevention (such as circumcision) on ideological rather than factual grounds. But what is worse are the consequences of 'irrational activism': obstructing serious debate on important ethical issues in HIV/AIDS science, and possibly undermining important avenues of research in the struggle against a deadly global epidemic.

ACT-UP Paris has not been slow to respond to the article on its website. Unfortunately, as a rebuttal, it seems to be all over the map. They understand Geffen and Gonsalves to be accusing them of being rabidly 'anti-science', and spend much time declaring how much they like science, how much they are in the company of scientists and how capable they are of reading scientific protocols. In regard to their 'mediatic' actions (such as tossing symbolically red jam at the exhibits of pharmaceutical companies), they defend their tactics of bringing ". . . to the public arena the problems of research and reverse power relations that are most often not in the favor of persons living with HIV/AIDS." At a certain point, their response to the accusation of irrational activism looks, well, irrational:

Doing treatment activism also means raising political issues. What is anti-scientific about that? Do you want us to think that science is ideologically pure and that researchers don't have to [sic] society and those who they work for?

Readers are advised to have a look at the article and the webpage -- as well as whatever reliable supporting documents they can get their hands on -- and come to their own conclusions as to whether this heated debate is a sign of health or sickness within the AIDS activist community.

The UNESCO Declaration on Bioethics and Human Rights on tour in Asia

The Beijing Olympics, among other things, have turned a spotlight on the rising economic and political power of Asia. The Chinese government response to the Tibet issue and its dismissive stance towards accusations of human rights abuses, as well as the incapacity of Western powers to offer anything more than symbolic objections, indicate that Asian values are not going to bow down to Occidental influences. A recent conference on in Seoul, the International Forum on Bioethics and Asian Culture, underscores this development. One of the key themes of the conference was how UNESCO's Declaration on Bioethics and Human Rights applied to Asian culture, given that the Declaration aims at having universal application. Some speakers pointed out that the centrality of family in Asian culture, also in medical decision-making, was not at all prominent in the Declaration: the term 'family' does not appear in the document at all, which seems to expose an individualistic bias in the text. Others noted that the Declaration has much to say about rights, but little to say about duties, again raising the accusation of a 'Western' slant to a purportedly universal code of bioethics. Ditto for the prominence of respect for persons in the Declaration, and its faint attention to respect for authority, government, and religious tradition.

Of course, the sharp contrasts between the values in the Declaration and Asian values break down at closer inspection: the world of values is a messy place, respecting no man-made boundaries, with plenty of mixing, matching and cross-pollination. Still, it is not clear how a truly universal declaration of bioethics is supposed to emerge from the global plurality of values, and still be relevantly applicable to it.

Bioethical transitions

In public health, they have the theory of 'epidemiological transitions'. Usually this refers to changes in disease patterns in a population, and more specifically, the change from infectious (such as cholera) to chronic diseases (such as Alzheimer's). These transitions, according to the theory, go hand in hand with large-scale social and economic developments, as well as biological, cultural and environmental factors. Some countries, once marked by high prevalence of infectious diseases, are starting to see a rise in rates of cancer and hypertension.

There seems to be an analogous 'bioethical transition' afoot, particularly visible in rapidly emerging economic giants like India and China. Not too long ago, the primary bioethics questions in such countries were about primary health care and resource shortages, but as new technologies increasingly enter into the picture, you start to see questions about prenatal diagnosis, allocation of respirators, or use of embryonic stem cells trickling in. True, these kinds of questions currently crop up among a social elite in these countries, and for that reason, these sorts of issues should not dominate academic or media attention. But the fact is that these new issues are there, along with the more traditional challenges, and have to be dealt with in ways that resonate with local sensibilities and values.

Backlash against the 'AIDS industry'?

This week sees the launch of the XVII International AIDS Conference in Mexico City. Some of what is going on in the conference can be followed on the website that the Kaiser Family Foundation has set up. But you really have to be there to get the buzz, the celebrities, the infighting, as well as whatever new research results are on offer. Part of my summer reading has included Elizabeth Pisani's The Wisdom of Whores: Bureaucrats, Brothels and the Business of AIDS, in which she describes the XV International AIDS Conference as follows:

In 2004 Thailand hosted the Fifteenth International AIDS Conference. Once upon a time, these conferences were about science. Nowadays they are about institutional posturing, theatrical activism and money. Lots of money. The Bangkok conference cost US $18.5 million. Nearly 19,000 people rocked up to it, scrummaging for the goodie back-packs given out by pharmaceutical companies. Big pharma paid handsomely to nab the best real estate, the exhibition booths in the center of the main hall. They paid again to get their booths dressed to impress, with cappucino bars, and indoor waterfall and larger-than-life photos of gleaming Western labs and grateful African children. Conference goers could admire a fabulous selection of ball gowns by Brazilian designer Adriana Bertini, all made of condoms. They could gawp at dancing elephants and Puppets against AIDS. Delegates paid around US $1000 each to attend this jamboree.

In the bad old days, the complaint was that not enough was being spent on HIV/AIDS: it was a disease of gay men and junkies, and no one wanted to touch it. The newer complaints are that too much is being spent on HIV/AIDS (relative to other serious health-related conditions) or that too much is being wastefully spent on wrongheaded approaches to the epidemic. Why so much spending on HIV/AIDS and so little for maternal and child health? Why was the importance of partner reduction neglected amid fruitless battles between those (liberals) promoting condoms and those (conservatives) promoting abstinence? To the extent that these complaints are true, these shortcomings would constitute a massive ethical failure, not just a public health one.

So while the official slogan of the conference is Universal Action Now, the unofficial buzzword seems to be: backlash. There is talk of a backlash against the struggle against HIV/AIDS. It is not the misfortune of research into new HIV prevention interventions (in microbicides and vaccines) having gone south last year. This does not help, but that is a setback, not a backlash. The backlash starts from the observation that a kind of private-public industrial complex has developed around a single disease to an extent unparelleled in the history of public health, leading to questions about whose interest(s) this burgeoning industry ultimately serves, especially when -- despite the increasing funding of research and programs -- new HIV infections continue apace and only a fraction of those who need AIDS treatment receive it. Even the head of the HIV/AIDS department of the World Health Organization has muddied the waters by stating that a generalized HIV epidemic outside sub-Saharan Africa may be over, which many took as meaning that HIV is a non-issue if you are not gay, a drug user, or African. Against this background, the International AIDS Conference, with its bling and glitter, can act as a lightning rod for skepticism, conspiracy theories, and general ridicule.

On the other hand: HIV has entered human ecology, and is not going to go away anytime soon. Millions of people continue to die of AIDS, and it is incurable. The virus is extremely complex and adaptive. It impacts low-income countries disproportionately. Basic research, epidemiological studies and the implementation of HIV/AIDS programs around the world don't come cheap. Perhaps a way of dealing with the backlash is to advocate for greater funding and human resources devoted to all diseases (including HIV/AIDS) responsible for high levels of preventable morbidity and mortality worldwide, while fighting against the politicization of approaches to prevent sexual transmission of HIV, and practicing vigilance in regard to the role of pharmaceutical companies within the fight against HIV/AIDS. The HIV/AIDS community has to combat the virus as well as its own tendencies. This is going to continue to be messy, but there is no way back.