The Poison Review

I am a little late getting to this, but the article “Deadly Medicine” from the January issue of Vanity Fair is vitally important and an absolute must-read. The piece, by Donald Bartlett and James Steele, describes how many (if not most) clinical trials of new drugs are now being conducted in third world and developing countries, where oversight is often absent, documentation  spotty,  financial conflict of interest rampant, and informed consent nonexistent.  Similar points were made in a 2009 “Sounding Board” piece in the New England Journal of Medicine on “Ethical and Scientific Implications of the Globalization of Clinical Research“.

[Addendum: 4/8/11]: On further reflecction, it seems to me that the New England Journal of Medicine piece is more balanced, as it weighs carefully (some may say too carefully) the potential advantages and disadvantages of globalizing clinical research.  Some advantages:

• Lower costs of doing research in developing countries reduces the cost of brining a drug to market.
• A large pool of potential subjects will accelerate recruitment and shorten the time require to study a new drug.
• Lower burdens of redundant and unnecessary regulation will also reduce costs and shorten timelines.

However, these potential advantages come at the cost of considerable possible risks:

• Regulatory agencies in countries where the drugs studied are likely to be marketed heavily — such as the United States — have limited ability to monitor research conducted in other parts of the globe.
• Ethical oversight of research involving human subjects in developing countries may be compromised.
• Results of research done in developing countries may not be generalizable to other areas where patients may not have the same genetic makeup, underlying medical conditions, or standards of medical care as do the research subjects.

To my mind, the major flaw in the the NEJM piece is that it lacks a healthy cynicism, and doesn’t take into consideration the power of the profit motive that may be a strong impediment to conduction of ethical, transparent research.  My advice would be to read both Vanity Fair and NEJM on this topic, and