When a story comes out called Big Pharma's Global Guinea Pigs
, you can be sure of a number of things. There will be talk about the Tuskagee syphilis study, and if the author has been getting out lately, reference to the recent revelations about abusive US-led research in Guatamala during the 1940's. There will be mention of pharmaceutical companies outsourcing their research to cut costs, avoid red tape (read: institutional review boards) and gain access to research participants who are 'drug naive' (read: do not have regular access to adequate health care). The fact that FDA makes overseas site inspections as frequently as solar eclipses is brought in, giving the impression that when trials take place abroad, no one is really at the regulatory wheel. There is a good deal of truth to all of this, and perhaps it needs to be said repeatedly, given the challenges that the 24-hour news cycle poses to human retention. But it does get pretty tedious, so at this point I tend to scan these sorts of texts in search of a new twist.
The new twist in this particular news item is this:
In the United States, the Justice Department has mounted an investigation under the Foreign Corrupt Practices Act to see if drugmakers are offering overseas bribes, and clinical trials are firmly in the spotlight. That's because doctors in many countries are government employees and therefore any payments to them deemed above fair market value might be viewed as bribes. Britain, too, is introducing a strict new Bribery Act in July that also covers such overseas payments.
This is new, because most news items about global health research are focused on the possibility of research participants being exploited. Here, it is about alleged harm caused to medical institutions and patients by paying health care workers too much. Because just paying persons too much is not in itself a bribe: it is a bribe when the person starts bending rules for money, like a policeman on the take. And the rules being bent might come down to harm to research participants in the end, such as when overseas physicians in the pocket of Big Pharma 'massage' inclusion criteria for studies in order to satisfy the need for large sample sizes. As the global health research market grows, gets more diverse and complex, and the usual suspects get increasingly aware of the usual criticisms, the emergent ethical problems appear as new wrinkles in the old story.
Labels: bioethics, pharmaceutical industry