Last week President Obama issued a memo calling for calling for the Presidential Commission for the Study of Bioethical Issues to "conduct, beginning in January 2011, a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government." The call was prompted by revelations earlier this fall that the U.S. Public Health Service conducted STD research on unsuspecting Guatemalans in the 1940s. But, as work by Duke authors attests, that was not an isolated incident.
In his recent book The Professional Guinea Pig, Roberto Abadie details how the pharmaceutical research industry uses human test subjects in sometimes ethically suspect ways. Abadie sees the commission as a positive development. He says, "The Presidential commission on ethics is an important step in understanding the role of the US government in this scandal but also in devising ways to protect current research subjects domestically and also abroad where most research will be conducted in the following years. It is important that the commission moves beyond abstract ethical principles and invocations and towards effective policy recommendations that recognize the changing landscape of human research protection. One important deficit the commission should address, for example, is the lack of a registry of research subjects' participation in clinical trials research covering all phases in clinical trials research both domestically and internationally. Without this instrument we are not able to tell how many trials a research subject has volunteered for, or if he or she is doing more than one trial at the same time, compromising thus, not only their well being but also the validity of the whole trial."
Karla FC Holloway is also working on issues of ethics in medical research. Her book Private Bodies, Public Texts will be out next March. She is also hopeful about the commission, saying "It's both appropriate and just that the president will convene a particular panel for this discussion. Bioethicists have identified certain subjects as 'vulnerable' for scores of years. But we have been less willing to acknowledge that that vulnerability is directly tied to social judgments about the quality of personhood, the value of certain lives, and the competition of scientific and research objectives—especially when it is centered on bodies that have less social capital. It's important to tie vulnerability to its source in order to make sure we don't allow our stereotypes to follow us into clinical research paradigms."
There are multiple problems. First and foremost "involuntary" nontherapeutic research that harms needs to be banned 100%. Secondly, victims of such should be able to make claims and get compensation for that harm. This has not been easy for involuntary human research subjects in the past.
Thirdly, not all Federal agencies are bound by the Common Rule. Apparently Guantanamo shows that maybe those that are bound by it have violated it anyway. Federal regulation, human subjects protection and oversight needs to be across the board.
Next, Abadie for example, is making statements about the pharmaceutical industry. The Common Rule only applies to federally funded research and therefore, while his request for oversight of all human subjects trials is important, the Presidential memo does not address that issue. In fact, state funded, institutionally funded and privately funded research can be just as harmful as Federal research.
Abadie looks at trials with presummably volunteers. All human subjects research needs to have oversight. The interest for me, however, is in nontherapeutic involuntary research. I am interested in it because I myself am a victim and I will say that actual crimes have been committed against me during the course of this experimentation. My inability to get justice for those is an indication of who is in the know about these experiment.
If Guatemala had a sobering effect on the President, one can only wonder what his reaction will be if and when he finds out what is happening now. It is much worse than Guatemala or Tuskegee. And to make the situation more difficult for victims - I have communications interferences when I try to contact those who can help or who would be able to pinpoint whose research interests my experimentation serves. And to add more dirt to the pile, there are fakes on the internet intentionally disinforming victims.
This is very much like MK Ultra and its repercussions - no criminal prosecutions and many delusional cover stories.
It's about time that there is some accountability for this. I for one will emigrate the first chance I have. I've had it with this place.
Posted by: Viola L | February 20, 2011 at 11:50 PM