ORGAN HARVESTING & THE USE OFINMATES FOR MEDICAL STUDIES Could It Ever Happen In America?Paris, Thursday, June 15, 2000An Execution for a Kidney China Supplies Convicts' Organs to MalaysiansBy Thomas Fuller International Herald TribuneMALACCA, Malaysia - The night before their execution, 18 convicts were shown on a Chinese television program, their crimes announced to the public. Wilson Yeo saw the broadcast from his hospital bed in China and knew that one of the men scheduled to die would provide him with the kidney he so badly needed. Mr. Yeo, 40, a Malaysian who manages the local branch of a lottery company here, says he never learned the name of the prisoner whose kidney is now implanted on his right side. He knows only what the surgeon told him: The executed man was 19 years old and sentenced to die for drug trafficking. ''I knew that I would be getting a young kidney,'' Mr. Yeo says now, one year after his successful transplant. ''That was very important for me.'' Over the past few years at least a dozen residents of this small Malaysian city have traveled to a provincial hospital in Chongqing, China, where they paid for what they could not get in Malaysia: functioning kidneys to prolong their lives.
They went to China, a place most of them barely knew, with at least $10,000 in cash. They encountered a medical culture where kidneys were given to those with money and a doctor could stop treatment if a patient didn't pay up. Surgeons advised them to wait until a major holiday, when authorities traditionally execute the most prisoners. China's preferred method of capital punishment, a bullet to the back of the head, is conducive to transplants because it does not contaminate the prisoners' organs with poisonous chemicals, as lethal injections do, or directly affect the circulatory system,
as would a bullet through the heart. More than 1,000 Malaysians have had kidney transplants in China, according to an estimate by Dr. S.Y. Tan, one of Malaysia's leading kidney specialists. Many patients go after giving up hope of finding an organ donor in Malaysia, where the average waiting period for a transplant is 16 years. Interviews with patients who underwent the operation in China reveal how the market for Chinese kidneys has blossomed here - to the point where patients from Malacca negotiated a special price with Chinese doctors.
In 1998, two doctors from the Third Affiliated Hospital, a military-run complex in Chongqing, came to Malacca and spoke at the local chapter of the Lions Club about their procedures. Kidney patients worked out a deal with the doctors: Residents of Malacca would be charged $10,000 for the procedure instead of the $12,000 paid by other foreigners.
It goes without saying that the kidney transplants these doctors perform are highly controversial. The Transplantation Society, a leading international medical forum based in Montreal, has banned the use of organs from convicted criminals. Human rights groups call the practice barbaric. But patients here who have undergone the operation in China say they were too desperate at the time to consider the ethical consequences. Today they are simply happy to be alive. The trip to Chongqing offered them an escape from the dialysis machines, blood transfusions, dizziness and frequent bouts of vomiting. And why, they ask, should healthy organs be put to waste if they can save lives?
''Ethics are only a game for those people who are not sick,'' says Tan Dau Chin, a
paramedic who has spent his career working with dialysis patients in Malacca.
''Let me put it this way: What if this happened to you?'' Simon Leong, 35, a Malaccan who underwent a successful operation two years ago in Chongqing, says the principle of buying an organ is ''wrong.'' ''But I was thinking, I have two sons. Who's going to provide for them?''
Corrine Yong, 54, who returned from Chongqing two months ago after a successful operation, was told that if she did not receive a transplant she would probably not live much longer. ''I didn't have a choice,'' she says of her decision to go to China.
For kidney patients in Malaysia the chances of obtaining a transplant from a local donor are slim. Despite an extremely high death rate on Malaysian roads - in a country of 22 million people, an average of 16 people are killed every day in traffic accidents - the organ donation system is woefully undeveloped.
Kidneys were transplanted from just eight donors last year. Thousands of people are on the official waiting list. Dr. Tan, the Malaysian kidney specialist, says the small number of donors in Malaysia is partly due to religious and cultural taboos. Malaysian Muslim families in particular are reluctant to allow organs to be removed before burial, although this is not the case in some other Muslim countries, such as Saudi Arabia, which has a relatively high number of donors.Organ donation has always been an uncomfortable issue. The terminology is euphemistic and macabre: Doctors speak of ''harvesting'' organs from patients who are brain-dead, but whose hearts are still beating. And when the issue of executed prisoners comes into play, transplants become politically explosive.'' It is well known that the death penalty is often meted out in China for things that most people in Western countries would not regard as capital crimes,'' said Roy Calne, a professor of surgery at both Cambridge University and the National University of Singapore. Using organs from executed prisoners is not only ethically wrong, he says, but discourages potential donors to step forward in China: ''If the perception of the public in China is that there's no shortage of organs you're not likely to get any enthusiasm for a donation program.'' It is impossible to know exactly how many Asians travel to China for organ transplants. But data informally collected from doctors in at least three countries suggest the numbers are in the hundreds every year.
Also impossible to confirm is whether all patients in China receive organs from executed prisoners and not other donors. But patients interviewed for this article say doctors in China make no secret of where the organ comes from. The day before convicts are executed - usually in batches - a group of patients in the hospital are told to expect the operation the next day.
Melvin Teh, 40, a Malacca businessman who received a kidney transplant from a hospital in Guangzhou two years ago, says doctors did not offer the names of the prisoners. ''They just tell you it was a convict,'' he said. ''They don't tell you what he did. ''Mrs. Yong says doctors told her that the donors were all ''young men'' who had committed ''serious, violent'' crimes.
Chinese officials have admitted that organs are occasionally taken from convicts, but deny that the practice is widespread. 'It is rare in China to use the bodies of executed convicts or organs from an executed convict,'' an official from the Health Ministry was quoted as saying in the China Daily in 1998. ''If it is done, it is put under stringent state control and must go through standard procedures. ''That view does not jibe with the stories that patients from Malacca tell, where kidneys are essentially handed out to the highest bidders, often foreigners. Mr. Leong, the Chongqing patient, and his wife, Karen Soh, who accompanied him to China, say money was paramount for the surgeons involved in the operation. They recounted how another Malaysian kidney transplant patient who suffered complications while in Chongqing had run out of cash. They stopped the medication for one day,'' Mrs. Soh said, referring to the anti-rejection drugs. The patient was already very sick and eventually died of infection upon her return to Malaysia, according to Mrs. Soh.
Patients say they are advised by friends who have already undergone a transplant to bring the surgeons gifts. Mrs. Yong brought a pewter teapot and picture frame. Mrs. Soh and her husband brought a bottle of Martell cognac, a carton of 555 brand cigarettes and a bottle of perfume for the chief surgeon's wife. ''They call it 'starting off on the right foot,''' Mrs. Soh said.
After the operation was complete, the couple gave two of the doctors ''red packets'' filled with cash: 3,000 yuan ($360) for the chief surgeon, and 2,000 yuan for his assistant.
Other patients also ''tipped,'' although the amounts varied.
It might be tempting to see the market for Chinese organs as part of the more general links that overseas Chinese have with the mainland. Many of the patients are indeed ethnically Chinese and come from countries - Malaysia, Taiwan, Thailand - with either links to the mainland or large ethnic Chinese populations.
Yet if the experience of Malaysian patients is any indication, the trip to China provides a severe culture shock. Patients recalled unsanitary conditions, and for those who did not speak Mandarin the experience was harrowing.
Mr. Leong, who speaks little Mandarin, was helped by his wife who wrote out a list of phrases for her husband to memorize. The list included: ''I'm feeling pain!'''I'm thirsty.'' ''Can you turn me over?'' Mr. Leong would simply say the number that corresponded to his complaint and the nurse would check the list.
But more difficult than communicating is paying for the transplant. For the Leongs it involved pooling savings from family members and appealing for funds through Chinese-language newspapers. The cost of an operation amounts to several years' salary for many Malaysians.
Yet despite financial problems and culture shock, all four patients interviewed for this article said they had no regrets.
Mr. Yeo enjoys a life of relative normalcy, maintaining a regular work schedule and jogging almost every day. He says he was so weak before his transplant that he had trouble crossing the street and climbing stairs. Four-hour sessions three times a week on dialysis machines were ''living hell.''
Does it disturb him that an executed man's kidney is in his abdomen? ''I pray for the guy and say, 'Hopefully your afterlife is better,''' Mr. Yeo said.
And has he ever wondered whether the prisoner might have been innocent?
Mr. Yeo pauses and stares straight ahead. ''I haven't gone through that part -
the moral part,'' he said. ''I don't know. I can't question it too much. I have to live.''
© International Herald TribuneWe'd like to answer that question for you, because we were sent a flyer from an inmate here in Connecticut, that sure sounds like they are asking these people to donate their organs. It says as followed:
WHAT YOU SHOULD KNOW ABOUT:
THE INMATE BODY-ORGAN/DONOR PROGRAM
TELEPHONE# 1-800-GIVE-LI(F)E 0R 1-800-355-SHARE OR http://matchingdonor.com
On the back of the filer it says:
CT. D. O. C. 24 Wolcott Hill RD. Weathers Field CT Tel: # 860-692-7481* www.state.ct.us/doc 06109State of Connecticut D. O. C. / Ellis MacDougall C. I. 1153 East Street South Suffield, CT. 06080 TEL: 860-627-2100
ATTN: Inmate Body-Organ-Blood/Donor Program
Contact Person: F. Acilitator
So now tell me what you think, E-mail me with your comments
I have NOT checked into all of this YET but I will.
But should you have any questions regarding this matter Feel Free to contact the
Department of Corrections.
Posted on
Wed,
Jul. 12, 2006
Use of
Inmates for Medical Studies gets a New Look
By Dawn Fallik
The Philadelphia Inquirer
Columbia Ledger Enquirer, GA
http://www.ledger-
enquirer.com/ mld/ledgerenquir er/news/nation/ 15023653. htm
PHILADELPHIA -
Thirty years ago, the federal government severely
limited medical experimentation on prisoners after the discovery that
pharmaceutical companies and medical researchers were using
Philadelphia
inmates as medical guinea pigs.
Now, an independent
panel has suggested easing those bonds. But with
the lingering specter of Nazi experiments and the local Holmesburg
prison scandal, some say the door should remain shut.
"This is a
dangerous cul-de-sac to go down again," said A. Bernard
Ackerman, a
New York dermatologist
who worked at Holmesburg prison as
a second-year resident at the University of Pennsylvania during the
trials. "There has to be experimentation in medicine, but populations
that are aged, vulnerable or defective mentally should not be used."
The much awaited Institute
of Medicine's report, released Wednesday,
suggested prisoners could benefit from clinical trials so long as the
trials were in the final phase of FDA approval, did not involve any
cosmetic toxicity testing, and ensured that half the subjects in each
trial were non-inmates.
Trials would be
subject to an independent review panel, including a
prisoner advocate. There would be no compensation and no special
treatment at the prison.
"I don't want the door open to everything," said G. David Curry, an
Institute
of Medicine
committee member and criminology professor at
the University of Missouri-St. Louis who has conducted sociological
studies involving prisoners. "I can't imagine how abusive that could
be."
The report also pointed out one glaring concern - even with the
federal restrictions, a small number of prison research studies are
under way. But no one knows exactly what is being done where, and
there is no central agency to oversee them.
For example, the
University
of Pennsylvania is currently conducting
about 30 studies involving prisoners, including re-entry programs and
alcohol treatment programs. But the federal Office for Human Research
Protections listed only the two it funded in its national database of
355 trials.
The Institute Of
Medicine review came at the request of the Office
for Human Research Protections, said Ernest D. Prentice, chair of the
agency's advisory committee. He emphasized that the report was a
starting point, and that it would be a long time before any
regulations would be amended, if ever.
With the prison
population quadrupling to almost 7 million in the
past 30 years, and a higher percentage of prisoners living with HIV
and Hepatitis C, officials wondered if they were doing more harm than
good by keeping clinical trials out. The trials often involve studies
of new drugs or whether counseling methods are effective.
"The regulations were written in an era of protectionism - that
taking part in research was bad and they needed to be protected,"
Prentice said. "We don't have that same view anymore."
There is a long, terrible history of abuse involving medical
treatments and prisoners in Pennsylvania. In the 1960s, Albert
Kligman, now a professor emeritus of dermatology at Penn, conducted
experiments at the Holmesburg prison.
About 300 former
inmates have sued Kligman, the City of Philadelphia,
and Penn, alleging they were tested with infectious agents,
radioactive isotopes, dioxin, and psychotropic drugs in exchange for
nominal payments. They say they were told the agents were harmless.
The class action was dismissed in 2002 due to the statute of
limitations, but the former inmates are planning an appeal. Kligman,
who has denied any wrongdoing, could not be reached for comment.
Throughout the report, committee members strongly emphasize the moral
obligation to make sure a Holmesburg does not happen again.
But even
so, Curry hesitated before signing it, worried that
prisoners, by virtue of their incarceration, cannot truly give
informed consent.
"Can anyone in prison really be given assurance that confidentiality
will be maintained?" he asked. "Everyone knows everything that goes
on in a prison."
He said he signed after other restrictions, such as the cosmetic test
ban, were added.
Allen M. Hornblum, a Temple
University urban studies professor and
author of ``Acres of Skin,'' a book that detailed the Holmesburg
research, said prisoners should not be used in medical experiments.
"This is like
putting the good housekeeping seal saying it's now OK
to do some of these things," he said.
But committee members, who held public forums around the country and
heard from prisoners as well as researchers, including Hornblum, said
that there had to be a way to learn from the lessons of the past and
move forward.
Jonathan Moreno, director of the center for biomedical ethics at the
University
of Virginia, said
behavioral research should be encouraged
in light of the increasing number of mental health issues among
prisoners
and their families.
"I don't see this as kicking open a door," he said. "I see this as
building a new room where new work can be done."
In
the wake of the pharmaceutical fiascoes involving pain medications, such as
Vioxx and Bextra, the need for human test subjects has increased immensely. Both
drugs were pulled from the market when dangerous, perhaps life-threatening
problems were discovered, problems that likely would have been caught had the
drugs been tested on a larger number of patients.
So, where are drug companies turning for test subjects now? An unlikely source,
indeed: prisons. And it seems these companies may not have a difficult time
pitching their drugs to inmates. The Institute of Medicine of the National
Academy of Sciences issued a report Aug. 1 recommending regulations limiting
testing of pharmaceuticals on inmates be loosened. Currently, under regulations
passed in 1978, prisoners can partake in federally financed biomedical research
if the tests pose no more than "minimal" risks. Loosening the restrictions would
allow for experiments with greater risks, a practice essentially abolished after
abuse was exposed.
Though inmates would have the
"choice" of participating in these trials, it is logical to worry perhaps the
risks of participating would not be fully disclosed and, even if prisoners were
presented with all the facts, that many would not understand the medical and
legal jargon used by the pharmaceutical companies.
The withholding of information is what caused prison testing to all but cease in
the early 1970s, after revelations of abuse were exposed in what the government
called the "Tuskegee Study of Untreated Syphilis in the Negro Male." In this
study, which began 40 years earlier, hundreds of men with syphilis were left
untreated in the presence of a cure so the effects of the disease could be
studied. In another instance at Holmesburg Prison in Philadelphia, inmates were
paid hundreds of dollars a month and exposed to radioactive and carcinogenic
materials.
Abuse has taken place in the past, and though more
oversight is promised should restrictions be lifted, there isn't much to keep it
from happening again. Simply put, the number of volunteers available for medical
testing is dwindling, and the cost of testing is rising as a result; so much so
that the Tufts Center for the Study of Drug Development estimates contracting of
the research industry grew from $1 billion in 1995 to $7 billion in 2005.
So, in an industry in which making money is key, what is a pharmaceutical
company to do? Seek out cheap, likely uneducated subjects at prisons across the
country. Though proponents of loosening restrictions cite the potential benefits
to prisoners, this is clearly about reducing costs and targeting those who,
because of their circumstances, are likely to be coerced into participating in
high-risk trials.
In Iowa,
prisoners are prohibited from participating in drug testing or any kind of
medical research while incarcerated. However, should inmates being treated for
diseases be offered experimental treatment options, they may choose those
options. If this is the case, regulations guiding involvement include an
institutional review board that mandates an advocate for the prisoner (either a
lawyer or someone knowledgeable about prison conditions and prisoner rights),
and the case is reviewed.
Financial motivations in this
situation are not difficult to identify, and the health and safety of
individuals, even if they are prisoners, should always be put first.
Panel Suggests Using Inmates in Drug Trials
By IAN URBINA
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.
http://www.nytimes.
com/2006/ 08/13/us/ 13inmates. html?
ei=5029&en=cbba2e66207e7872&ex=1156132800&partner=RRSANDIEGO&pagewanted=print
Inmates as Guinea Pigs? Not so fast
By Elisa Cramer HASH(0x609070) Friday, September 29, 2006 Leodus Jones took the words right out of my mouth."This moves us back in a very bad direction," he said to The New York Times about plans by the federal government to reopen medical testing on prisoners.
Yes, backward was the word that came to my mind, too, when I read reports by and about a federal panel of medical advisers recommending changes in the rules governing drug trials using prison inmates. Because they're three decades old. Because the number of people in prison, jail or on probation or parole has more than quadrupled since the rules were written. Because the research could "impart benefits."
The report, Ethical Considerations for Research Involving Prisoners (see www.nap.edu ), speaks repeatedly of safeguards and ethical concerns, of ensuring that inmates are not experimented on simply because "prisoners are a convenient source of subjects." But this country's history of treating prisoners, the poor and - as seen by the Tuskegee syphilis experiment - racial minorities as expendable for some greater good makes it difficult to believe that ethical considerations will be paramount now simply because a panel said so.
Even the authors of the report acknowledge that the federal government is not currently equipped to handle the recommendations. The Office for Human Research Protections, a division of the U.S. Health and Human Services Department, "needs major reinforcement, since it lacks adequate funding and personnel to carry out its work for the three agencies already within its purview, much less any expanded responsibilities. "
The remedy? "If OHRP cannot effectively carry out broader assignment," according to the report, "Congress should create a new entity to do so."
Let me get this straight. Congress, which refused to buck the pharmaceutical industry to protect seniors and disabled beneficiaries of Medicare Part D, now is expected to counter the pharmaceutical industry to protect prisoners?
Leodus Jones was one of the prisoners at the Holmesburg penitentiary, in Pennsylvania, where, from 1951 to 1974, inmates were paid hundreds of dollars a month to be exposed to radioactive, hallucinogenic and carcinogenic chemicals as part of several medical experiments conducted by federal agencies and private companies. He told the Times his skin color changed in one experiment, and he still develops rashes on his back and legs from where lotions had been tested. Other inmates, now released, have enduring health problems.
One dermatologist who worked at Holmesburg during the experiments in the 1960s told the Times: "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."
Before the abuses came to light in the '70s, the drug industry relied on prisoners for 90 percent of its trials. The rules the panel seeks to change practically stopped such federally financed experiments. Without the coercible inmate population to draw from, the industry now spends billions to recruit volunteers and conducts trials overseas.
Before expanding the use of jailed "volunteers" for medical experiments, inmates need to be provided adequate health care, so the experiments don't appear to be the only available treatment of illnesses. Financial incentives for inmates with little or no comparable way of acquiring money also negate the notion that consent is voluntary. At Holmesburg, for example, inmates could earn up to $1,500 a month by participating in the experiments, versus working for 15 to 25 cents a day in the shoe factory, shirt factory or commissary.
The Health and Human Services Department committee that requested the panel's report will meet Nov. 2. Any changes to the current rules must ensure that this country does not ethically go backward.
Find this article at:
http://www.palmbeac hpost.com/ opinion/content/ opinion/epaper/ 2006/09/29/ a12a_cramercol_ 0929.html