IOM Panel Recommends Using Prison Inmates as Guinea Pigs in Drug Trials_NYT

The New York Times reports (below) that The Institute of Medicine (IOM) panel–which includes a well known bioethicist–recommended lifting 1978 federal regulations restricting the use of prisoners in medical experiments.

What the Times didn’t tell readers is that the IOM is not the independent body of scientists it pretends. IOM members constitute an elite–members only association of physicians and academics who individually or throught their academic institutions have a significant financial stake in the pharmaceutical-biotech industry.

The panel voted shamelessly to recommend violating the Nuremberg Code (1947) and the federal restrictions (1978) on the proscription against the use of prisoners in medical experiments–because such experiments constitute an exploitation of prisoners who are precluded by their status from saying NO to high risk medical experiments.

In July 2005, at the invitation of the  IOM committee I gave testimony on behalf of the Alliance for Human Research Protection about prison research at the panel’s meeting in San Francisco. I provided evidence of current–as opposed to historic–prison research abuse by the University of Texas and the University of California, SF. I pleaded against weakening federal restrictions from a moral position, recognizing that prisoners are human beings.

The documented testimony includes information that most educated people are unaware of. It is posted at:
http://www.ahrp.org/testimonypresentations/CheaperThanChimpanzees0705.php  

AHRP is committed to openness and full disclosure. We believe in  accountability of those who influence public policy.
As the Times reports (below) the recommendation is entirely commercially driven:  “The discussion comes as the biomedical industry is facing a shortage of testing subjects.”

The INSTITUTE OF MEDICINE COMMITTEE ON ETHICAL CONSIDERATIONS FOR REVISIONS TO
DHHS REGULATIONS FOR PROTECTION OF PRISONERS INVOLVED IN RESEARCH

LAWRENCE O. GOSTIN (Chair), Georgetown University Law Center, Washington, DC
HORTENSIA AMARO, Northeastern University, Boston, MA
PATRICIA BLAIR, University of Texas Health Center at Tyler, Tyler, TX
STEVE J. CAMBRA, Jr., Cambra, Larson & Associates. Elk Grove, CA
G. DAVID CURRY, University of Missouri-St. Louis, St. Louis, MO
CYNTHIA A. GÓMEZ, University of California, San Francisco
BRADFORD H. GRAY, The Urban Institute, Washington, DC
MICHAEL S. HAMDEN, North Carolina Prisoner Legal Services, Inc., Raleigh, NC
JEFFREY L. METZNER, University of Colorado School of Medicine, Denver, CO
JONATHAN MORENO, University of Virginia, Charlottesville, VA
LARRY I. PALMER, University of Louisville, Louisville, KY
NORMAN G. POYTHRESS, Jr., University of South Florida, Tampa, FL
WILLIAM J. ROLD, New York City, NY
JANETTE Y. TAYLOR, University of Iowa, Iowa City, IA
WENDY VISSCHER, RTI International, Research Triangle Park, NC
BARRY ZACK, Centerforce, San Quentin, CA

A letter to The New York Times was sent today. Will keep you posted on its disposition.l

Contact: Vera Hassner Sharav
veracare@ahrp.org
 

http://www.nytimes.com/2006/08/13/us/13inmates.html?_r=1&oref=slogin

THE NEW YORK TIMES
Panel Suggests Using Inmates in Drug Trials
By IAN URBINA
 August 13, 2006

PHILADELPHIA, Aug. 7 — An influential federal panel of medical advisers has
recommended that the government loosen regulations that severely limit the
testing of pharmaceuticals  on prison inmates, a practice that was all but
stopped three decades ago after revelations of abuse.

The proposed change includes provisions intended to prevent problems that
plagued earlier programs. Nevertheless, it has dredged up a painful history
of medical mistreatment and incited debate among prison rights advocates and
researchers about whether prisoners can truly make uncoerced decisions,
given the environment they live in.

Supporters of such programs cite the possibility of benefit to prison
populations, and the potential for contributing to the greater good.

Until the early 1970’s, about 90 percent of all pharmaceutical products were
tested on prison inmates, federal officials  say. But such research
diminished sharply in 1974 after revelations of abuse at prisons like
Holmesburg here, where inmates were paid hundreds of dollars a month to test
items as varied as dandruff treatments and dioxin, and where they were
exposed to radioactive, hallucinogenic and carcinogenic chemicals.

In addition to addressing the abuses at Holmesburg, the regulations were a
reaction to revelations in 1972 surrounding what the government called the
Tuskegee Study of Untreated Syphilis   in the Negro Male, which was begun in
the 1930’s and lasted 40 years. In it, several hundred mostly illiterate men
with syphilis in rural Alabama were left untreated, even after a cure was
discovered, so that researchers could study the disease.

“What happened at Holmesburg was just as gruesome as Tuskegee, but at
Holmesburg it happened smack dab in the middle of a major city, not in some
backwoods in Alabama,” said Allen M. Hornblum, an urban studies professor at
Temple University  and the author of “Acres of Skin,” a 1998 book about the
Holmesburg research. “It just goes to show how prisons are truly distinct
institutions where the walls don’t just serve to keep inmates in, they also
serve to keep public eyes out.”

Critics also doubt the merits of pharmaceutical testing on prisoners who
often lack basic health care.

Alvin Bronstein, a Washington lawyer who helped found the National Prison
Project, an American Civil Liberties Union  program, said he did not believe
that altering the regulations risked a return to the days of Holmesburg.

“With the help of external review boards that would include a prisoner
advocate,” Mr. Bronstein said, “I do believe that the potential benefits of
biomedical research outweigh the potential risks.”

Holmesburg closed in 1995 but was partly reopened in July to help ease
overcrowding at other prisons.

Under current regulations, passed in 1978, prisoners can participate in
federally financed biomedical research if the experiment poses no more than
“minimal” risks to the subjects. But a report   formally presented to
federal officials on Aug. 1 by the Institute of Medicine  of the National
Academy of Sciences   advised that experiments with greater risks be
permitted if they had the potential to benefit prisoners. As an added
precaution, the report suggested that all studies be subject to an
independent review.

“The current regulations are entirely outdated and restrictive, and
prisoners are being arbitrarily excluded from research that can help them,”
said Ernest D. Prentice, a University of Nebraska  genetics  professor and
the chairman of a Health and Human Services Department   committee  that
requested the study. Mr. Prentice said the regulation revision process would
begin at the committee’s next meeting, on Nov. 2.

The discussion comes as the biomedical industry is facing a shortage of
testing subjects. In the last two years, several pain medications, including
Vioxx and Bextra, have been pulled off the market because early testing did
not include large enough numbers of patients to catch dangerous problems.

And the committee’s report comes against the backdrop of a prison population
that has more than quadrupled, to about 2.3 million, over the last 30 years
and that disproportionately suffers from H.I.V.  and hepatitis   C, diseases
that some researchers say could be better controlled if new research were
permitted in prisons.

For Leodus Jones, a former prisoner, the report has opened old wounds. “This
moves us back in a very bad direction,” said Mr. Jones, who participated in
the experiments at Holmesburg in 1966 and after his release played a pivotal
role in lobbying to get the regulations passed.

In one experiment, Mr. Jones’s skin changed color, and he developed rashes
on his back and legs where he said lotions had been tested.

“The doctors told me at the time that something was seriously wrong,” said
Mr. Jones, who added that he had never signed a consent form. He reached a
$40,000 settlement in 1986 with the City of Philadelphia after he sued.

“I never had these rashes before,” he said, “but I’ve had them ever since.”

The Institute of Medicine report was initiated in 2004 when the Health and
Human Services Department asked the institute to look into the issue. The
report said prisoners should be allowed to take part in federally financed
clinical trials so long as the trials were in the later and less dangerous
phase of Food and Drug Administration   approval. It also recommended that
at least half the subjects in such trials be nonprisoners, making it more
difficult to test products that might scare off volunteers.

Dr. A. Bernard Ackerman, a New York dermatologist who worked at Holmesburg
during the 1960’s trials as a second-year resident from the University of
Pennsylvania , said he remained skeptical. “I saw it firsthand,” Dr.
Ackerman said. “What started as scientific research became pure business,
and no amount of regulations can prevent that from happening again.”

Others cite similar concerns over the financial stake in such research.

“It strikes me as pretty ridiculous to start talking about prisoners getting
access to cutting-edge research and medications when they can’t even get
penicillin and high-blood-pressure pills,” said Paul Wright, editor of
Prison Legal News , an independent monthly review. “I have to imagine there
are larger financial motivations here.”

The demand for human test subjects has grown so much that the so-called
contract research industry has emerged in the past decade to recruit
volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug
Development, a Boston policy and economic research group at Tufts University
estimated that contract research revenue grew to $7 billion in 2005, up from
$1 billion in 1995.

But researchers at the Institute of Medicine said their sole focus was to
see if prisoners could benefit by changing the regulations.

The pharmaceutical industry says it was not involved. Jeff Trewitt, a
spokesman for the Pharmaceutical Research and Manufacturers of America, a
drug industry trade group, said that his organization had no role in
prompting the study and that it had not had a chance to review the findings.

Dr. Albert M. Kligman, who directed the experiments at Holmesburg and is now
an emeritus professor of dermatology at the University of Pennsylvania
Medical School, said the regulations should never have been written in the
first place.

“My view is that shutting the prison experiments down was a big mistake,”
Dr. Kligman said.

While confirming that he used radioactive materials, hallucinogenic drugs
and carcinogenic materials on prisoners, Dr. Kligman said that they were
always administered in extremely low doses and that the benefits to the
public were overwhelming.

He cited breakthroughs like Retin A, a popular anti-acne drug, and
ingredients for most of the creams used to treat poison ivy. “I’m on the
medical ethics committee at Penn,” he said, “and I still don’t see there
having been anything wrong with what we were doing.”

>From 1951 to 1974, several federal agencies and more than 30 companies used
Holmesburg for experiments, mostly under the auspices of the University of
Pennsylvania, which had built laboratories at the prison. After the
revelations about Holmesburg, it soon became clear that other universities
and prisons in other states were involved in similar abuses.

In October 2000, nearly 300 former inmates sued the University of
Pennsylvania, Dr. Kligman, Dow Chemical and Johnson & Johnson for injuries
they said occurred during the experiments at Holmesburg, but the suit was
dismissed because the statute of limitations had expired.

“When they put the chemicals on me, my hands swelled up like eight-ounce
boxing gloves, and they’ve never gone back to normal,” said Edward Anthony,
62, a former inmate who took part in Holmesburg experiments in 1964. “We’re
still pushing the lawsuit because the medical bills are still coming in for
a lot of us.”

Daniel S. Murphy, a professor of criminal justice at Appalachian State
University in Boone, N.C., who was imprisoned for five years in the 1990’s
for growing marijuana, said that loosening the regulations would be a
mistake.

“Free and informed consent becomes pretty questionable when prisoners don’t
hold the keys to their own cells,” Professor Murphy said, “and in many cases
they can’t read, yet they are signing a document that it practically takes a
law degree to understand.”

During the Holmesburg experiments, inmates could earn up to $1,500 a month
by participating. The only other jobs were at the commissary or in the shoe
and shirt factory, where wages were usually about 15 cents to 25 cents a
day, Professor Hornblum of Temple said.

On the issue of compensation for inmates, the report raised concern about
“undue inducements to participate in research in order to gain access to
medical care or other benefits they would not normally have.” It called for
“adequate protections” to avoid “attempts to coerce or manipulate
participation.’’

The report also expressed worry about the absence of regulation over
experiments that do not receive federal money. Lawrence O. Gostin, the
chairman of the panel that conducted the study and a professor of law and
public health at Georgetown University  said he hoped to change that.

Even with current regulations, oversight of such research has been
difficult. In 2000, several universities were reprimanded for using federal
money and conducting several hundred projects on prisoners without fully
reporting the projects to the appropriate authorities.

Professor Gostin said the report called for tightening some existing
regulations by advising that all research involving prisoners be subject to
uniform federal oversight, even if no federal funds are involved. The report
also said protections should extend not just to prisoners behind bars but
also to those on parole or on probation.

Professor Murphy, who testified to the panel as the report was being
written, praised those proposed precautions before adding, “They’re also the
parts of the report that faced the strongest resistance from federal
officials, and I fear they’re most likely the parts that will end up getting
cut as these recommendations become new regulations.”
Barclay Walsh contributed research for this article.

Copyright 2006  The New York Times Company <http://www.nytco.com/>

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.