Recently a research study conducted among drug users in China has been criticized by Human Rights Watch in the US. The study was published in Science. It studied ways of reducing drug cravings among heroin addicts in Chinese drug rehabilitation centers. Joseph Amon of Human Rights Watch criticized the study because it was not clear whether drug users who participated in the study where in the rehabilitation centers voluntarily or whether they received proven effective drug dependency treatment as part of their rehabilitation.
Human Rights Watch has previously criticized the conditions in Chinese drug rehabilitation centers. I will not comment on this criticism here. If one's position is that unfavorable conditions make all research in such centers unethical, irrespective of the nature of the study, then of course this study is also unethical. This is an extreme position, however, that would also make any prison research in the US unethical. It is widely agreed that US incarceration rates and policies do not conform to international standards; few would argue that this in and of itself makes all research in US prisons unethical.
There is nothing in the research procedures themselves that would even come close to being unethical. It is a noninvasive study where subjects were shown videos and their cravings measured by a questionnaire type study, using a visual analog scale. Informed consent was provided. The subjects were told that they did not have to participate in the study. Amon of Human Rights Watch has also not criticized the study as such, except for possibly a procedural violation, that it was not approved by the US NIH since investigators from NIDA (National Institute of Drug Abuse) are co-authors. It is unclear, however, whether even this would be required, as we are told that they were only involved in the writing of the paper for publication, and in any case is not a criticism of the content of the study.
The main question is therefore: Should useful and minimal risk research, of potential use to the research participants themselves, be allowed in places where alleged human rights violations take place? The answer to this question is obviously yes. Any other answer would prohibit all prison research in the US, and would prohibit lots of useful research on ways to improve human rights violations. This, of course, does not mean that all research in prisons or under less than ideal conditions are ethically acceptable. But we need to give specific reasons why or why not a study should be approved in these circumstances.
It is Joseph Amon who has behaved unethically by wrongfully accusing Chinese scientists of acting unethically. The same is true of a bioethicist such as Stuart Rennie in his blog, who repeats Amon's criticism, without attempting to give even a hint of an indication that anything specific happened in this study that could be labeled unethical. Both China and researchers are easy targets these days: Amon and Rennie assume that since this is human subjects research, and especially since it is done in China, there must be something unethical about it. No need to point out anything specific.
Wednesday, August 22, 2012
Sunday, August 5, 2012
Compulsory license, India and universal health insurance
India recently approved a compulsory license for the cancer drug sorafenib. Bayer sold this drug for about $5500 for a month's supply. A generic version in India will sell for $180 . The move by India has been widely applauded by international NGOs involved in health policy. They justify the decision by pointing out that most people in India have very low incomes and simply cannot afford the drug at the price that Bayer wanted to charge, thus denying them access to this life saving intervention. For public health reasons, therefore, the only solution is breaking the patent monopoly through issuing a compulsory license, allowable by international law.
Nobody supporting the move, however, has pointed out that the drug was deemed to be too expensive also for the public health system in the UK. In 2009 the National Institute for Health and Clinical Excellence (NICE) ruled against the use of sorafenib within the NHS. The drug, providing an increase in life expectancy of a few months on average, was not cost-effective compared with other health care interventions, given the price Bayer charged for the drug. We therefore have the paradox that the drug is deemed a high public health priority in India, but not in the UK.
Let us assume for the sake of argument that Bayer had legitimate development costs to get the drug approved, and that these are more than the 6% of the net sales during the patent period, which is what Natco, the Indian generic drug maker, is required to pay to Bayer. After all, somebody has to pay for the research and development. This will now be the general population in countries where there are no compulsory licensing for this drug. The part of the Indian population who is as wealthy as this general population will not be required to pay for the research and development costs. While this may be entirely appropriate, an argument that this is in accordance with our sense of justice is required before we can accept it.
More important, however, is the question whether funds should be used to buy this drug in India at all, given the state of its health care system. There is no reason to believe that sorafenib will be equally available to everyone in India. Only those with influence and access to the system will get it. In addition, other interventions, with much higher health benefits, are not available to the vast majority of the Indian population. Should not the funds to produce sorafenib be used to fund these interventions, for those in India who now do not have access to these high benefit interventions? Instead, those who already have good access will receive a drug with marginal health benefits.
This is not to argue that compulsory licensing is wrong or should not be used. It is only meant to show that the issue of compulsory licensing cannot be seen in isolation from the wider issue of access to health care in resource poor settings.
Nobody supporting the move, however, has pointed out that the drug was deemed to be too expensive also for the public health system in the UK. In 2009 the National Institute for Health and Clinical Excellence (NICE) ruled against the use of sorafenib within the NHS. The drug, providing an increase in life expectancy of a few months on average, was not cost-effective compared with other health care interventions, given the price Bayer charged for the drug. We therefore have the paradox that the drug is deemed a high public health priority in India, but not in the UK.
Let us assume for the sake of argument that Bayer had legitimate development costs to get the drug approved, and that these are more than the 6% of the net sales during the patent period, which is what Natco, the Indian generic drug maker, is required to pay to Bayer. After all, somebody has to pay for the research and development. This will now be the general population in countries where there are no compulsory licensing for this drug. The part of the Indian population who is as wealthy as this general population will not be required to pay for the research and development costs. While this may be entirely appropriate, an argument that this is in accordance with our sense of justice is required before we can accept it.
More important, however, is the question whether funds should be used to buy this drug in India at all, given the state of its health care system. There is no reason to believe that sorafenib will be equally available to everyone in India. Only those with influence and access to the system will get it. In addition, other interventions, with much higher health benefits, are not available to the vast majority of the Indian population. Should not the funds to produce sorafenib be used to fund these interventions, for those in India who now do not have access to these high benefit interventions? Instead, those who already have good access will receive a drug with marginal health benefits.
This is not to argue that compulsory licensing is wrong or should not be used. It is only meant to show that the issue of compulsory licensing cannot be seen in isolation from the wider issue of access to health care in resource poor settings.
Subscribe to:
Posts (Atom)