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Tuesday, August 15, 2006

Panel backs expansion of drug tests in prisons


By Ian Urbina The New York Times
Published: August 13, 2006

PHILADELPHIA An influential panel of medical advisers has recommended that the U.S. government loosen regulations that severely limit the testing of pharmaceuticals on inmates, a practice that was all but stopped three decades ago after disclosures 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 maltreatment and sparked debate among prison rights advocates and researchers about whether prisoners can make uncoerced decisions.

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

Until the early 1970s, about 90 percent of all pharmaceutical products were tested on inmates, federal officials say. But such research diminished sharply in 1974 after disclosures of abuse at places like Holmesburg Prison 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.

The regulations were also partly a reaction to the disclosure in 1972 of the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930s and lasted 40 years. In it, several hundred men with syphilis in rural Alabama, most of them illiterate, 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 Hornblum, an urban studies professor at Temple University here who wrote "Acres of Skin" in 1998, a book detailing 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 doubt the merits of pharmaceutical testing on prisoners who may lack basic health care.

"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."


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," Bronstein said, "I do believe that the potential benefits of biomedical research outweigh the potential risks."

For Leodus Jones, a former prisoner, the report has opened old wounds. "This moves us back in a very bad direction," said 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, 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 Jones, who said he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued over the experiments.

Dr. Bernard Ackerman, a New York dermatologist who worked at Holmesburg as a second-year resident from the University of Pennsylvania in the 1960s, said he remained skeptical.

"I saw it firsthand," Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

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.

Professor Ernest Prentice of the University of Nebraska, chairman of the federal committee, said the sole focus was to see if prisoners could benefit by changing the regulations.

"The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them," Prentice said. The regulation revision process will begin at the committee's next meeting, on Nov. 2, he said.

The U.S. prison population has more than quadrupled, to about 2.3 million, over the past 30 years and disproportionately suffers from HIV and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons.

The demand for human test subjects has grown so much that an industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development in Boston estimated that the industry's revenue grew to $7 billion in 2005, up from $1 billion in 1995.

In the past two years, several pain medications, including Vioxx and Bextra, have been pulled off the market. Early testing of those drugs did not include large enough numbers of patients to catch dangerous problems.

Barclay Walsh contributed research.

PHILADELPHIA An influential panel of medical advisers has recommended that the U.S. government loosen regulations that severely limit the testing of pharmaceuticals on inmates, a practice that was all but stopped three decades ago after disclosures 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 maltreatment and sparked debate among prison rights advocates and researchers about whether prisoners can make uncoerced decisions.

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

Until the early 1970s, about 90 percent of all pharmaceutical products were tested on inmates, federal officials say. But such research diminished sharply in 1974 after disclosures of abuse at places like Holmesburg Prison 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.

The regulations were also partly a reaction to the disclosure in 1972 of the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930s and lasted 40 years. In it, several hundred men with syphilis in rural Alabama, most of them illiterate, 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 Hornblum, an urban studies professor at Temple University here who wrote "Acres of Skin" in 1998, a book detailing 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 doubt the merits of pharmaceutical testing on prisoners who may lack basic health care.

"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."

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," Bronstein said, "I do believe that the potential benefits of biomedical research outweigh the potential risks."

For Leodus Jones, a former prisoner, the report has opened old wounds. "This moves us back in a very bad direction," said 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, 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 Jones, who said he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued over the experiments.

Dr. Bernard Ackerman, a New York dermatologist who worked at Holmesburg as a second-year resident from the University of Pennsylvania in the 1960s, said he remained skeptical.

"I saw it firsthand," Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

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.

Professor Ernest Prentice of the University of Nebraska, chairman of the federal committee, said the sole focus was to see if prisoners could benefit by changing the regulations.

"The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them," Prentice said. The regulation revision process will begin at the committee's next meeting, on Nov. 2, he said.

The U.S. prison population has more than quadrupled, to about 2.3 million, over the past 30 years and disproportionately suffers from HIV and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons.

The demand for human test subjects has grown so much that an industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development in Boston estimated that the industry's revenue grew to $7 billion in 2005, up from $1 billion in 1995.

In the past two years, several pain medications, including Vioxx and Bextra, have been pulled off the market. Early testing of those drugs did not include large enough numbers of patients to catch dangerous problems.

Barclay Walsh contributed research.

PHILADELPHIA An influential panel of medical advisers has recommended that the U.S. government loosen regulations that severely limit the testing of pharmaceuticals on inmates, a practice that was all but stopped three decades ago after disclosures 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 maltreatment and sparked debate among prison rights advocates and researchers about whether prisoners can make uncoerced decisions.

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

Until the early 1970s, about 90 percent of all pharmaceutical products were tested on inmates, federal officials say. But such research diminished sharply in 1974 after disclosures of abuse at places like Holmesburg Prison 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.

The regulations were also partly a reaction to the disclosure in 1972 of the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930s and lasted 40 years. In it, several hundred men with syphilis in rural Alabama, most of them illiterate, 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 Hornblum, an urban studies professor at Temple University here who wrote "Acres of Skin" in 1998, a book detailing 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 doubt the merits of pharmaceutical testing on prisoners who may lack basic health care.

"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."

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," Bronstein said, "I do believe that the potential benefits of biomedical research outweigh the potential risks."

For Leodus Jones, a former prisoner, the report has opened old wounds. "This moves us back in a very bad direction," said 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, 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 Jones, who said he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued over the experiments.

Dr. Bernard Ackerman, a New York dermatologist who worked at Holmesburg as a second-year resident from the University of Pennsylvania in the 1960s, said he remained skeptical.

"I saw it firsthand," Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

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.

Professor Ernest Prentice of the University of Nebraska, chairman of the federal committee, said the sole focus was to see if prisoners could benefit by changing the regulations.

"The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them," Prentice said. The regulation revision process will begin at the committee's next meeting, on Nov. 2, he said.

The U.S. prison population has more than quadrupled, to about 2.3 million, over the past 30 years and disproportionately suffers from HIV and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons.

The demand for human test subjects has grown so much that an industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development in Boston estimated that the industry's revenue grew to $7 billion in 2005, up from $1 billion in 1995.

In the past two years, several pain medications, including Vioxx and Bextra, have been pulled off the market. Early testing of those drugs did not include large enough numbers of patients to catch dangerous problems.

Barclay Walsh contributed research.

PHILADELPHIA An influential panel of medical advisers has recommended that the U.S. government loosen regulations that severely limit the testing of pharmaceuticals on inmates, a practice that was all but stopped three decades ago after disclosures 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 maltreatment and sparked debate among prison rights advocates and researchers about whether prisoners can make uncoerced decisions.

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

Until the early 1970s, about 90 percent of all pharmaceutical products were tested on inmates, federal officials say. But such research diminished sharply in 1974 after disclosures of abuse at places like Holmesburg Prison 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.

The regulations were also partly a reaction to the disclosure in 1972 of the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930s and lasted 40 years. In it, several hundred men with syphilis in rural Alabama, most of them illiterate, 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 Hornblum, an urban studies professor at Temple University here who wrote "Acres of Skin" in 1998, a book detailing 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 doubt the merits of pharmaceutical testing on prisoners who may lack basic health care.

"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."

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," Bronstein said, "I do believe that the potential benefits of biomedical research outweigh the potential risks."

For Leodus Jones, a former prisoner, the report has opened old wounds. "This moves us back in a very bad direction," said 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, 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 Jones, who said he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued over the experiments.

Dr. Bernard Ackerman, a New York dermatologist who worked at Holmesburg as a second-year resident from the University of Pennsylvania in the 1960s, said he remained skeptical.

"I saw it firsthand," Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

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.

Professor Ernest Prentice of the University of Nebraska, chairman of the federal committee, said the sole focus was to see if prisoners could benefit by changing the regulations.

"The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them," Prentice said. The regulation revision process will begin at the committee's next meeting, on Nov. 2, he said.

The U.S. prison population has more than quadrupled, to about 2.3 million, over the past 30 years and disproportionately suffers from HIV and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons.

The demand for human test subjects has grown so much that an industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development in Boston estimated that the industry's revenue grew to $7 billion in 2005, up from $1 billion in 1995.

In the past two years, several pain medications, including Vioxx and Bextra, have been pulled off the market. Early testing of those drugs did not include large enough numbers of patients to catch dangerous problems.

Barclay Walsh contributed research.

PHILADELPHIA An influential panel of medical advisers has recommended that the U.S. government loosen regulations that severely limit the testing of pharmaceuticals on inmates, a practice that was all but stopped three decades ago after disclosures 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 maltreatment and sparked debate among prison rights advocates and researchers about whether prisoners can make uncoerced decisions.

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

Until the early 1970s, about 90 percent of all pharmaceutical products were tested on inmates, federal officials say. But such research diminished sharply in 1974 after disclosures of abuse at places like Holmesburg Prison 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.

The regulations were also partly a reaction to the disclosure in 1972 of the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930s and lasted 40 years. In it, several hundred men with syphilis in rural Alabama, most of them illiterate, 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 Hornblum, an urban studies professor at Temple University here who wrote "Acres of Skin" in 1998, a book detailing 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 doubt the merits of pharmaceutical testing on prisoners who may lack basic health care.

"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."

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," Bronstein said, "I do believe that the potential benefits of biomedical research outweigh the potential risks."

For Leodus Jones, a former prisoner, the report has opened old wounds. "This moves us back in a very bad direction," said 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, 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 Jones, who said he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued over the experiments.

Dr. Bernard Ackerman, a New York dermatologist who worked at Holmesburg as a second-year resident from the University of Pennsylvania in the 1960s, said he remained skeptical.

"I saw it firsthand," Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

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.

Professor Ernest Prentice of the University of Nebraska, chairman of 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."

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," Bronstein said, "I do believe that the potential benefits of biomedical research outweigh the potential risks."

For Leodus Jones, a former prisoner, the report has opened old wounds. "This moves us back in a very bad direction," said 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, 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 Jones, who said he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued over the experiments.

Dr. Bernard Ackerman, a New York dermatologist who worked at Holmesburg as a second-year resident from the University of Pennsylvania in the 1960s, said he remained skeptical.

"I saw it firsthand," Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

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.

Professor Ernest Prentice of the University of Nebraska, chairman of the federal committee, said the sole focus was to see if prisoners could benefit by changing the regulations.

"The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them," Prentice said. The regulation revision process will begin at the committee's next meeting, on Nov. 2, he said.

The U.S. prison population has more than quadrupled, to about 2.3 million, over the past 30 years and disproportionately suffers from HIV and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons.

The demand for human test subjects has grown so much that an industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development in Boston estimated that the industry's revenue grew to $7 billion in 2005, up from $1 billion in 1995.

In the past two years, several pain medications, including Vioxx and Bextra, have been pulled off the market. Early testing of those drugs did not include large enough numbers of patients to catch dangerous problems.

Barclay Walsh contributed research.

PHILADELPHIA An influential panel of medical advisers has recommended that the U.S. government loosen regulations that severely limit the testing of pharmaceuticals on inmates, a practice that was all but stopped three decades ago after disclosures 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 maltreatment and sparked debate among prison rights advocates and researchers about whether prisoners can make uncoerced decisions.

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

Until the early 1970s, about 90 percent of all pharmaceutical products were tested on inmates, federal officials say. But such research diminished sharply in 1974 after disclosures of abuse at places like Holmesburg Prison 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.

The regulations were also partly a reaction to the disclosure in 1972 of the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930s and lasted 40 years. In it, several hundred men with syphilis in rural Alabama, most of them illiterate, 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 Hornblum, an urban studies professor at Temple University here who wrote "Acres of Skin" in 1998, a book detailing 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 doubt the merits of pharmaceutical testing on prisoners who may lack basic health care.

"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."

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," Bronstein said, "I do believe that the potential benefits of biomedical research outweigh the potential risks."

For Leodus Jones, a former prisoner, the report has opened old wounds. "This moves us back in a very bad direction," said 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, 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 Jones, who said he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued over the experiments.

Dr. Bernard Ackerman, a New York dermatologist who worked at Holmesburg as a second-year resident from the University of Pennsylvania in the 1960s, said he remained skeptical.

"I saw it firsthand," Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

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.

Professor Ernest Prentice of the University of Nebraska, chairman of the federal committee, said the sole focus was to see if prisoners could benefit by changing the regulations.

"The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them," Prentice said. The regulation revision process will begin at the committee's next meeting, on Nov. 2, he said.

The U.S. prison population has more than quadrupled, to about 2.3 million, over the past 30 years and disproportionately suffers from HIV and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons.

The demand for human test subjects has grown so much that an industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development in Boston estimated that the industry's revenue grew to $7 billion in 2005, up from $1 billion in 1995.

In the past two years, several pain medications, including Vioxx and Bextra, have been pulled off the market. Early testing of those drugs did not include large enough numbers of patients to catch dangerous problems.

Barclay Walsh contributed research.

PHILADELPHIA An influential panel of medical advisers has recommended that the U.S. government loosen regulations that severely limit the testing of pharmaceuticals on inmates, a practice that was all but stopped three decades ago after disclosures 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 maltreatment and sparked debate among prison rights advocates and researchers about whether prisoners can make uncoerced decisions.

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

Until the early 1970s, about 90 percent of all pharmaceutical products were tested on inmates, federal officials say. But such research diminished sharply in 1974 after disclosures of abuse at places like Holmesburg Prison 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.

The regulations were also partly a reaction to the disclosure in 1972 of the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930s and lasted 40 years. In it, several hundred men with syphilis in rural Alabama, most of them illiterate, 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 Hornblum, an urban studies professor at Temple University here who wrote "Acres of Skin" in 1998, a book detailing 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 doubt the merits of pharmaceutical testing on prisoners who may lack basic health care.

"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."

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," Bronstein said, "I do believe that the potential benefits of biomedical research outweigh the potential risks."

For Leodus Jones, a former prisoner, the report has opened old wounds. "This moves us back in a very bad direction," said 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, 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 Jones, who said he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued over the experiments.

Dr. Bernard Ackerman, a New York dermatologist who worked at Holmesburg as a second-year resident from the University of Pennsylvania in the 1960s, said he remained skeptical.

"I saw it firsthand," Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

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.

Professor Ernest Prentice of the University of Nebraska, chairman of the federal committee, said the sole focus was to see if prisoners could benefit by changing the regulations.

"The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them," Prentice said. The regulation revision process will begin at the committee's next meeting, on Nov. 2, he said.

The U.S. prison population has more than quadrupled, to about 2.3 million, over the past 30 years and disproportionately suffers from HIV and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons.

The demand for human test subjects has grown so much that an industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development in Boston estimated that the industry's revenue grew to $7 billion in 2005, up from $1 billion in 1995.

In the past two years, several pain medications, including Vioxx and Bextra, have been pulled off the market. Early testing of those drugs did not include large enough numbers of patients to catch dangerous problems.

Barclay Walsh contributed research.

PHILADELPHIA An influential panel of medical advisers has recommended that the U.S. government loosen regulations that severely limit the testing of pharmaceuticals on inmates, a practice that was all but stopped three decades ago after disclosures 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 maltreatment and sparked debate among prison rights advocates and researchers about whether prisoners can make uncoerced decisions.

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

Until the early 1970s, about 90 percent of all pharmaceutical products were tested on inmates, federal officials say. But such research diminished sharply in 1974 after disclosures of abuse at places like Holmesburg Prison 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.

The regulations were also partly a reaction to the disclosure in 1972 of the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930s and lasted 40 years. In it, several hundred men with syphilis in rural Alabama, most of them illiterate, 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 Hornblum, an urban studies professor at Temple University here who wrote "Acres of Skin" in 1998, a book detailing 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 doubt the merits of pharmaceutical testing on prisoners who may lack basic health care.

"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."

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," Bronstein said, "I do believe that the potential benefits of biomedical research outweigh the potential risks."

For Leodus Jones, a former prisoner, the report has opened old wounds. "This moves us back in a very bad direction," said 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, 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 Jones, who said he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued over the experiments.

Dr. Bernard Ackerman, a New York dermatologist who worked at Holmesburg as a second-year resident from the University of Pennsylvania in the 1960s, said he remained skeptical.

"I saw it firsthand," Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

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.

Professor Ernest Prentice of the University of Nebraska, chairman of the federal committee, said the sole focus was to see if prisoners could benefit by changing the regulations.

"The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them," Prentice said. The regulation revision process will begin at the committee's next meeting, on Nov. 2, he said.

The U.S. prison population has more than quadrupled, to about 2.3 million, over the past 30 years and disproportionately suffers from HIV and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons.

The demand for human test subjects has grown so much that an industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development in Boston estimated that the industry's revenue grew to $7 billion in 2005, up from $1 billion in 1995.

In the past two years, several pain medications, including Vioxx and Bextra, have been pulled off the market. Early testing of those drugs did not include large enough numbers of patients to catch dangerous problems.

Barclay Walsh contributed research.

1 comment:

Stiletto Tongue said...

This is terrifying.
Huxleyan fiction cum reality.

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