What sets human research subjects apart from animals is the universal
prohibition enshrined in the Nuremberg Code:
"The voluntary consent of the human subject is absolutely essential.  This
means that the person involved should have legal capacity to give consent;
should be so situated as to be able to exercise free power of choice,
without the intervention of any element of force, fraud, deceit, duress,
over-reaching, or other ulterior form of constraint or coercion; and should
have sufficient knowledge and comprehension of the elements of the subject
matter involved as to enable him to make an understanding and enlightened
decision."

The editorial affirms the Nuremberg Code unconditional bottom line, but the
editorial attempts to put  the IOM panel's recommendations in the best
possible light.  " While acknowledging the seriousness of the problem, the
report’s authors believe that it can be overcome — at least in some
institutions and in some settings — by having careful independent boards
oversee the process."

The IOM panel call for "greatly expanding the protections" while engaging in
the dismantling of protections is a commonplace method for spinning a
controversial policy for which there is no public support. There is no
palatable rationale behind the move because it is motivated by expediency
and utilitarian ethics. The issue is not what the report's authors
"believe"--but rather the evidence of abuse and exploitation that cannot be
eradicated.

It is clear to this critic that the authors of the IOM report who
disingenuously cite oversight by "careful independent boards" as protection
against abuse--are both intellectually dishonest and not forthcoming about
their institution's stake in this lucrative industry. 

To cite but one example: one of the IOM panelists, Wendy Visscher, is the
director of RTI --Research Triangle Park, NC--Office of Research Protection.
A list of RTI clients--include major Big Pharma companies, government
agencies, and universities--all of who are eager to use prisoners. 
http://www.rti.org/newsroom/news.cfm?nav=483&objectid=3A05B5B8-B975-414E-BF0ACBE6A5869122 

The list of clients tells us all we need to know about who is
behind the move to gain access to prisoners as experimental animals.

In 2000, the federal Office of Human Research Protections (OHRP), suspended
federally funded research projects at the University of Texas Medical Branch
(UTMB) in Galveston because the university had not followed federal
regulations aimed at protecting research-study volunteers. Of some 300
studies suspended (in July 2000), 195 involved Texas prisoners; another 25
studies were brought to a halt in September 2000 [1] [2] UTMB is
aggressively seeking to broaden its prison drug trials.

A letter from the OHRP to UTMB ( September 14, 2000)  listed numerous
research projects that did not fall into any of the categories of
permissible research on prisoners, finding "scant evidence" that the
university's institutional review board followed federal regulations when it
reviewed and approved the studies  July 2000: http://www.hhs.gov/ohrp/detrm_letrs/jul00c.pdf; 

September 2000 http://www.hhs.gov/ohrp/detrm_letrs/sep00b.pdf .

In 2002, another IOM panel headed by a Harvard Distinguished Professor of
Medicine, examined the current system of subject protections in non-prison
research. That report [3] acknowledged systemic failure: "It is
understandable that the public has come to perceive that research
institutions put more emphasis on insulating themselves from liability than
on protecting people from harm'' http://www.iom.edu/CMS/3740/4870/4459.aspx 

The recommendation to remove restrictions on prisoner research comes at
precisely a time when research abuses and research calamities in the
unicarcerated population have been brought to light. Do the IOM panelists
think that prisoners will fare better?

Did the IOM panelists read the  six-part special investigative report by Bloomberg News [4],  December 2005?
The report pulled the blinders off to reveal the truth about how the clinical drug trial industry actually operates.
The report also lays bare the utterly dysfunctional IRB gatekeeping system whose inherent conflicts of interest only members of the IRB community fail
to recognize.
Indeed, Dr. Greg Koski, former head of the federal Office of Human Research
Protection-- the federal agency that is supposed to oversee federally funded
clinical trials, and the IRB system--acknowledged the systemic failure:
"It's not really a 'few bad apples' problem. We need to create a system that
grows better apples."

The Bloomberg report is an indictment of the stakeholders who profit from
the exploitation of desperate, poor, and disenfranchised people--immigrants,
children, homeless people, and others who are used and abused as guinea
pigs. Can anyone argue that prisoners would fare better?

The year, 2006 was the year in which a catastrophic medical experiment
nearly killed all previously healthy volunteers [5]. The revelations that
have emerged about the approval process and lack of safeguards for the human
subjects of TGN1412  shook the medical research community [6]. But despite
evidence of systemic research protection failings,  the IOM panel was not
dissuaded from proceeding to unhinge the restrictions on use--always
synonymous with abuse--of prison population. The IOM panel delivered the
recommendation that it had been convened to deliver--on time, no matter
what.

The Times editorial is clearly uneasy about the IOM recommendations,
cautioning: "the country should move slowly on this issue."
But for all its effort to pretend that it is possible to conduct medical
research in prison--"carefully with maximum transparency and concern for
inmate safety," is akin to claiming that one can be "a little bit pregnant."

None of the IOM recommendations that the Times applauds--except the one
lifting federal restrictions--have a ghost of a chance of ever being
implemented. To think otherwise is to be deluded. In fact, we don't even protect innocent
preschool children from hazzardous psychotropic drug experiments.

If public debate is the hallmark of democracy, and the subject of prisoner
research deserves an editorial, why, one wonders, did the NYT fail to
publish letters to the editor allowing readers to express their views about
the news report recommending the liftin of restrictions on prison research?

Below is my letter which evidently was not seen "fit to print."

References:

1.For references to prison experiemntation see: "Cheaper than Chimpanzees,"
testimony before the IOM panel http://www.ahrp.org/cms/content/view/218/139/

2. Four part investigative series, "Sick in Secret: The Hidden World of
Prison Health Care," by Mike Ward and Bill Bishop in the Texas Statesman
(December 2001-2003) uncovered a covert, interlocking system of abuse in the
Texas prison health care system operated by the University of Texas Medical
Branch (UTMB) since 1993. http://www.prisons.org/American-Statesman.htm

3. Responsible Research: A Systems Approach to Protecting Research
Participants: http://www.iom.edu/CMS/3740/4870/4459.aspx

4. See: Big Pharma's Shameful Secret: Every Year, Scores of Human Test
Subjects are Injured or Killed, 2005:
http://www.ahrp.org/infomail/05/11/03.php

5.  Drug trial firm knew of risk: The consent form for test that left six
men critically ill listed a side effect which can seriously harm the immune
system Jo Revill, health editor, The Observer, Sunday April 9, 2006
http://observer.guardian.co.uk/uk_news/story/0,,1750055,00.html

6. Michael D E Goodyear,  Further lessons from the TGN1412 tragedy: New
guidelines call for a change in the culture of research, BMJ. 2006 August 5;
333(7562): 270–271. http://bmj.bmjjournals.com/cgi/content/full/333/7562/270

Contact: Vera Hassner Sharav
This email address is being protected from spam bots, you need Javascript enabled to view it
 

http://www.nytimes.com/2006/08/23/opinion/23wed1.html?
THE NEW YORK TIMES
 August 23, 2006
Editorial
Safe Drug Testing in Prisons

Prisoners’ rights advocates are understandably worried about an advisory
panel’s recommendation that the government overhaul the rules for testing
drugs on prison inmates. The advocates fear a return to the medieval
situation of just 30 years ago, when inmates were often subjected to
dangerous and unethical experimental procedures. Some were infamously
exposed to radioactive, carcinogenic and hallucinogenic chemicals at the
Holmesburg prison in Philadelphia.

This shameful history makes it imperative that any change in testing
policies be accompanied by oversight regulations far stronger than those now
in existence. That said, a new report from the Institute of Medicine offers
a possible outline for moving toward a system of testing that could benefit
both the population as a whole and prison inmates, who tend to be among the
sickest, most disease-prone people in society.

The report calls for greatly expanding the protections given to subjects of
medical research who are imprisoned or under other forms of correctional
supervision. It also calls on the government to strengthen federal oversight
of these kinds of studies and to rewrite a set a vague regulations that
don’t actually protect the rights of medical research subjects within the
corrections system.

The new arrangement would minimize inmate risk by limiting drug trials to
the final, therapeutic stage, after researchers have already determined that
drugs look safe and potentially effective. Instead of loading up studies
with captive subjects, as was commonly done in the past, prison inmates
would not be permitted to make up more than half of the subjects of a test.

No research can ever be seen as legitimate without informed consent of the
participating subjects. Critics of the new report argue that there can be no
such thing as informed consent in the coercive environment of a prison.
While acknowledging the seriousness of the problem, the report’s authors
believe that it can be overcome — at least in some institutions and in some
settings — by having careful independent boards oversee the process. If
voluntary informed consent is not obtainable, the report said, the research
should not be allowed to proceed.

The dismal state of medical care in many prisons also raises the possibility
that inmates would rush to sign up for drug trials simply to get treatment
for chronic problems. The report’s authors appear to have argued vigorously
among themselves about whether drug testing should be permitted at
institutions where health care is particularly poor. The answer should be
no, in all but the rarest cases. Making sure inmates have decent medical
care should be the first order of business.

The country should move slowly on this issue. The savage and dishonorable
legacy of drug testing in prison makes it imperative that any change be
carried out carefully, with maximum transparency and concern for inmate
safety. That will require far more federal oversight than current law
provides.

Copyright 2006 The New York Times Company FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

-----Original Message-----
From: VERACARE [mailto: This email address is being protected from spam bots, you need Javascript enabled to view it ]
Sent: Sunday, August 13, 2006 3:00 PM
To: ' This email address is being protected from spam bots, you need Javascript enabled to view it '
Subject: Prisoner Research: "Panel Suggests Resuming Use of Inmates in Drug
Trials"

Letter to the Editor:

Re: “Panel Suggests Resuming Use of Inmates in Drug Trials” [News, Aug.13]
The 1947 Nuremberg Code prohibition on the use of prisoners in medical
experiments did not end the practice. The catalyst that first pricked public
conscience was a 1973 essay by Jessica Mitford in The Atlantic Monthly,
"Experiments Behind Bars: Doctors, Drug Companies, and Prisoners."  Mitford
quoted a doctor who revealed prisoners' financial attraction: "Criminals in
our penitentiaries are fine experimental material - and much cheaper than
chimpanzees."

Prisoners’ only armor against experimental abuse is a single federal
regulation (adopted in 1978) restricting use of prisoners. The panel of the
Institute of Medicine (IOM) announced its recommendation to loosen federal
restrictions—even as a catastrophic drug experiment has revealed disturbing
safety loopholes (“British Rethinking Test Rules After Drug Trial Nearly
Kills 6” April 8). The IOM panel’s announcement leaves little doubt that the
overriding consideration was commercial: “The discussion comes as the
biomedical industry is facing a shortage of testing subjects.”

How far down the slippery moral slope are we willing to slide to accommodate
a $7 billion drug testing industry whose ethics violations are a continuing
subject of front page news and litigation?

Vera Hassner Sharav
President, ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
New York City

*Note: As one of the few invited critics of the effort to loosen federal
restrictions governing prisoner research, I testified before this IOM panel
at a meeting in San franciso (July 18, 2005). Documented evidence of
CURRENT--as opposed to historic--abusive prisoner experimentation in Texas
and California--was provided. The referenced testimony, "Cheaper than
Chimpanzees" is posted at:
http://www.ahrp.org/testimonypresentations/CheaperThanChimpanzees0705.php#r5

~~~~~~~~~~~~~~~~~~~

Research Triangle International--RTI

Private Sector Clients

Advanced Ceramics Research, Inc.  Amgen  Astec Industries, Inc. AstraZeneca
Bayer Becton, Dickinson & Co. Boehringer Ingelheim Bristol-Myers Squibb Co.
Centocor The CIIT Centers for Health Research Dominion Resources Inc. Dow
Pharmaceutical Sciences E.I. duPont de Nemours & Co., Inc. Eastman Chemical
Co. Education Assistance Corp. Elan Pharmaceuticals Eli Lilly and Company
EMD Pharmaceuticals GlaxoSmithKline  Inspire Pharmaceuticals International
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Companies Kimberly-Clark Corp. Microbia, Inc. Nielsen Media Research
Novartis Organon Pfizer Progress Energy Purdue Pharma L.P. Reichhold, Inc.
Rite Aid Corp. Roche Laboratories Roth Associates, Inc.
Sanofi-Aventis The Society of the Plastics Industry Sumitomo Corporation
Syngenta Crop Protection Underwriters Laboratories 
 
Other Clients
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Multiple Sclerosis Society North Carolina Utilities Commission People's
Republic of China Project Bread -- The Walk for Hunger Robert Wood Johnson
Foundation Rockefeller Foundation Samueli Institute State of California
State of Florida State of New York State of North Carolina State of Vermont
United Nations World Bank World Health Organization

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Corporation for National & Community Service Department of Agriculture
Department of Commerce Department of Defense Department of Education
Department of Energy Department of Health and Human Services
• Administration for Children and Families 
• Agency for Healthcare Research and Quality
• Agency for Toxic Substances and Disease Registry
• Centers for Disease Control and Prevention
• Centers for Medicare and Medicaid Services (CMS) (formerly Health
Care Financing Administration)
• Health Resources and Services Administration
• National Institutes of Health
o National Cancer Institute
o National Center for Research Resources 
o National Eye Institute
o National Heart, Lung, and Blood Institute
o National Institute on Aging
o National Institute of Alcohol Abuse and Alcoholism
o National Institute of Allergy and Infectious Diseases
o National Institute of Child Health and Human Development
o National Institute on Deafness and Other Communication Disorders
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o National Institute on Drug Abuse
o National Institute of Environmental Health Sciences
o National Institute of Mental Health
o National Institute of Neurological Disorders and Stroke
• National Toxicology Program
• Substance Abuse and Mental Health Services Administration 

RTI's capabilities are extended through collaboration with university
faculty and staff. Our clients benefit from these affiliations, which extend
from our local founding universities to institutions around the world.
Three North Carolina universities---Duke University in Durham, the
University of North Carolina at Chapel Hill, and North Carolina State
University in Raleigh---incorporated RTI in 1958.
We are a separately operated affiliate of these schools and maintain our own
staff and offices. We collaborate with their scientists on research programs
and projects and maintain such relationships as adjunct faculty
appointments, cooperative research programs, and other professional
contacts. RTI also participates with universities and businesses in the
Microelectronics Center of North Carolina and the North Carolina
Biotechnology Center.

In addition to our founding universities, RTI’s relationships include specific programs and projects with
Boise State University
Boston University Medical Campus
Brandeis University
Brown University
Carnegie Mellon University
Case Western Reserve University
Columbia University
Duke University Medical Center
Emory University
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