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Maureen C. Kelly's and Samuel J. Tilden's Ethical and Legal Oversight of Human Subjects Research in Emerging Infections and Biodefense Research: A Review of Recent Changes and Call for Policy Reform, 8 Hous. J. Health L. & Pol'y 1 (2007).
The central issue grappled with in this article is an interesting one, though a little explanation is needed before it can be stated. Under U.S. Federal law, no drugs (or vaccines) are legally available for widespread medical use unless they've passed through a rigorous, expensive, and time-consuming testing process. Generally, the process starts with showing a credible (even if theoretical) biochemical basis for believing the drugs will work. If the drug shows positive effects and manageable side effects after intense animal testing, permission might be given for small-scale testing in a sample batch of human subjects (if they've given informed consent, of course). Only then, if the results are favorable in the small sample, will testing be authorized on larger samples and, if successful, approval given for general medical use.
A key problem with this research paradigm is in the field of preventative biodefense research. Simply put, testing a drug or vaccine on human subjects is impossible unless those persons already suffer from the harmful biological agent--which will be rare or impossible unless germ warfare has already begun. Under current legal and ethical guidelines, it's impossible to expose a test subject to a harmful pathogen solely for the purpose of seeing if a potential treatment is effective. Since pre-attack small-scale human testing is impossible, no new biodefense drugs would ever be approved until after the problem had occurred--and at that point, waiting months or years for the normal approval process to conclude could leave thousands or millions dead.
Thus, this article talks about post 9/11 legislation that authorizes emergency approval of biodefense agents even if the normal testing process has not been concluded. The risk remains, of course, that the untested vaccine or "cure" may be worse than the disease. Although the article is rather dry and technical, the underlying issues it raises are certainly intriguing.
The central issue grappled with in this article is an interesting one, though a little explanation is needed before it can be stated. Under U.S. Federal law, no drugs (or vaccines) are legally available for widespread medical use unless they've passed through a rigorous, expensive, and time-consuming testing process. Generally, the process starts with showing a credible (even if theoretical) biochemical basis for believing the drugs will work. If the drug shows positive effects and manageable side effects after intense animal testing, permission might be given for small-scale testing in a sample batch of human subjects (if they've given informed consent, of course). Only then, if the results are favorable in the small sample, will testing be authorized on larger samples and, if successful, approval given for general medical use.
A key problem with this research paradigm is in the field of preventative biodefense research. Simply put, testing a drug or vaccine on human subjects is impossible unless those persons already suffer from the harmful biological agent--which will be rare or impossible unless germ warfare has already begun. Under current legal and ethical guidelines, it's impossible to expose a test subject to a harmful pathogen solely for the purpose of seeing if a potential treatment is effective. Since pre-attack small-scale human testing is impossible, no new biodefense drugs would ever be approved until after the problem had occurred--and at that point, waiting months or years for the normal approval process to conclude could leave thousands or millions dead.
Thus, this article talks about post 9/11 legislation that authorizes emergency approval of biodefense agents even if the normal testing process has not been concluded. The risk remains, of course, that the untested vaccine or "cure" may be worse than the disease. Although the article is rather dry and technical, the underlying issues it raises are certainly intriguing.
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