IOM Recommends Expanded Research on Prisoners; NEJM Editor Defends TGN1412

Sept. 2006: Dr. Jeffrey Drazen, editor of The New England Journal of Medicine defends TGN1412 “the work must go on.”
Dr. Jeffrey Drazen, editor in chief of the New England Journal of Medicine, who has never (to our knowledge) criticized a clinical trial for ethical violations, defended the TGN1412 lethal experiment stating:

“As long as we continue to manipulate biology in new ways, we probably cannot prevent all such events from occurring. We must do what we can to minimize risk, but the future health of the world population demands that we not let adverse events put an end to medical progress… The troubling fact of the matter is that without people who are willing to place themselves at risk to advance our knowledge, we will be frozen in our current state of understanding.”

A fair question might be: How many times has Dr. Drazen put his own life at risk “to advance our knowledge?”

The Institute of Medicine recommends expanding research on prisoners
The Institute of Medicine (IOM) Report recommended “Simplifying” Federal Regulations on prison research and expanding the definition of “prisoner” to include those on parole and probation. The term “simplifying” is a euphemism for withdrawing federal restrictions on the use of prisoners in research.

Federal Regulations on Prison Research (45 CFR 46 Subpart C) were enacted in 1978 to stop the exploitation of prisoners in often highest risk, harm producing experiments.  The IOM committee “rejects strong protectionism” – i.e., the legal protection of Subpart C which recognizes that prisoners cannot exercise the right to voluntary, uncoerced, informed consent.

Another IOM recommendation would expand the definition of “prisoner” to include those on parole and probation – thereby greatly expanding the pool of potential human subjects of medical experiments. The International Centre for Prison Studies indicates the U.S. has the largest incarcerated prison population in the world. The IOM Report acknowledges that 2.1 persons were in prisons and 4.9 were on parole or probation; that brings the total to close to 7 million.

The report contends that if more researchers have greater access to prisoners, prisoners would have greater access to healthcare. The report further notes that to minimize coercion to participate in the studies, greater access to healthcare within prisons would be needed to conduct justifiable research. The IOM report makes the unfounded unlikely claim that “access to research may be critical to improve the health of prisoners and the conditions in which they live…” that is sheer speculation; it is no guarantee. In reality it assumes –even in the knowledge from past experience – that the tail will wag the dog.

The proposed change in the regulations would create the largest population of controlled and traceable research subjects in the world at a time when there is a severe shortage of biomedical research subjects among the general public. Such a controlled population would create a very large, lucrative testing pool for future medical researchers and drug companies.

“More test subjects may result in shorter trial periods and possibly decrease the risk of litigation caused by a harmful product being brought to market too early due to insufficient testing. These are prized benefits for researchers, but offer increased risks to the trial subjects.”
(Prison Legal News, 2008)