Pubdate: Sun, 13 Aug 2006
Source: New York Times (NY)
Copyright: 2006 The New York Times Company
Contact:  http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Author: Ian Urbina
Note: Barclay Walsh contributed research for this article.
Bookmark: http://www.mapinc.org/prison.htm (Incarceration)
Bookmark: http://www.mapinc.org/find?247 (Crime Policy - United States)

PANEL SUGGESTS USING INMATES IN DRUG TRIALS

PHILADELPHIA -- 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."
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MAP posted-by: Richard Lake