Tuesday, March 17, 2009
Tuesday, March 10, 2009
Bioethics and the stimulus package
Shockingly, bioethics is considered one of those areas. Applications are requested for proposals about informed consent and data access policies; ethical issues of emerging technologies; ethical issues in health disparities and access to participation in research; ethics of sharing of electronic health information; ethics of translating genetic information into clinical practice; the ethical issues involved in the blurring of research and treatment; and research on recontact issues in genotype and genome-wide association studies. Those of us working in international bioethics and research ethics were especially excited by the sentence " ... studies are needed to assess the impact and ethical considerations of conducting biomedical and clinical research internationally in resource-limited countries." This is certainly a challenge topic, and no doubt relevant, given the increasing amount of US-funded or facilitated research taking place around the world, especially in the world's poorer countries.
And then came the fine print. A couple of days ago, the NIH added a notice to the request for applications. It reads:
Funding for this program is provided under the American Recovery and Reinvestment Act of 2009 (Recovery Act). The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, domestic (United States) institutions/organizations (i.e., those located in the 50 states, territories and possessions of the United States, Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia) who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 (aggregate total for all subcontracts and subawards), whichever is less.
This does not mean that you cannot propose an international research ethics project involving foreign collaborators and institutions. It just means that you have to find collaborators and institutions willing to swallow the fact that, even if the topic is about health disparities and research in low-income settings, 90% of the grant money must stay in the United States. Dealing with that painful irony may be a challenge in itself.
Monday, March 09, 2009
How friendly can Big Pharma be to developing countries in a down economy?
The head of GlaxoSmithKlein (GSK), Andrew Witty, apparently caused a stir at Harvard Medical School last month by promising that his company would make essential medicines accessible to developing countries and commit more resources to research on neglected diseases. More precisely, GSK will take 20% of its profits from sales in developing countries and reinvest back in local health care infrastructure, and patented medicines produced by GSK will be sold at 25% of their market value in the 50 poorest countries of the world. In addition, there was talk of a 'patent pool' for neglected diseases, i.e. an agreement between various patent-holders to share (for some fee) those patents with each other and with third parties.
These promises may make GSK look saintly, but the impression largely fades on reflection. 20% of GSK's profits in developing countries does not amount to much; an editorial in the Lancet calculates it as less than 0.1% of GSK's total profits, and the folks at Policy Innovations see this as boiling down to about $50,000 per country, hardly a generous investment in local health infrastructure. Selling patented medicines at a quarter of the usual (bloated) price may not be of much help either to those who live on a few dollars per day. And while giving access to patents sounds nice, the road from possession of patent information to research to marketing is a long and winding road paved by a great deal of money. Who has that kind of money? The big pharmaceutical companies, like GSK. But they won't really invest to create drugs for conditions affecting developing countries because the profit margin would be meagre. We come full circle.
Gestures of philanthropy towards the world's poorer nations, on the part of aggressively profit- seeking pharmaceutical companies, is to be taken with a grain of salt at the best of times. In a down economy, when pharmaceutical companies are merging for their own survival, full-blown skepticism is in order.
Sunday, March 01, 2009
The ethics of outsourcing clinical trials, one more time
There is little hint that such responsibility needs to be -- for ethical and practical reasons -- shared with local communities in which research takes place, as well as national governments, ethics committees, research institutions, NGOs, and other stakeholders. Developing world researchers enter the picture indirectly, and mostly passively, as the recipients of training in conduct of clinical trials. True, there is talk of 'reaching international consensus' on the ethics of global clinical research, perhaps in conferences held by the WHO or Institute of Medicine, and folks from the developing world could come too. But in the end, with this sort of top-down (and North-South) approach, the chances that the recommendations will be taken up, put much of a dent in the ethical issues surrounding outsourcing of clinical research, seems pretty dim. And the fact that this commentary about ethics and the globalization of research seems to have been penned exclusively by US researchers is not necessarily damning, but also not very encouraging either.