Part 2 of 4

Monday, December 17, 2001

Becoming guinea pigs to avoid poor prison care Ill inmates urge each other to join experiments.

Becoming guinea pigs to avoid poor prison care Ill inmates urge each other to join experiments
By Mike Ward and Bill Bishop
American-Statesman Staff
Monday, December, 17, 2001

GALVESTON When they arrived at Stiles or Estelle or any of the hulking prisons wrapped in razor wire in East and South Texas, convicts especially those infected with HIV learned the first commandment for staying healthy: Get away from the prison clinics, where a federal judge in 1999 heard evidence of "significant, even deadly, inadequacies in the level of care provided to ill inmates." And find a way to Galveston, to the hospital operated by the University of Texas Medical Branch, where the same federal judge found the care to be "exemplary."

UTMB operates both, the prison hospital and the prison clinics. But the care was not the same. Inmates knew it, and they also knew there was one sure-fire way to get to Galveston: Join an experimental drug trial. Become a biomedical research "guinea pig" for UTMB.

Until late last year, UTMB conducted dozens and possibly hundreds of trials without telling state prison officials what it was doing violating a longstanding prison system rule. Inmates knew about the trials, however, and as they came to understand the failures of the prison health-care system, they agreed to join the drug tests. Their decisions weren't so much willing as they were fatalistic.

Televisions near the elevators at UTMB's public hospital in Galveston flashed advertisements earlier this year promising free treatment to anyone passing through the halls who would enroll in research trials for ear infections or allergies. An announcement about the next meeting of the Better Breathers Club followed a pitch for a research trial that included free pregnancy tests.

UTMB has run thousands of clinical research trials. Texas Tech University does fewer. The trials are a staple at medical schools.

UTMB currently has at least nine drug trials in which prisoners have been approved to participate. UTMB spokeswoman Doris White said Friday that the school doesn't keep a count of the number of convicts involved. Last year UTMB had about 200 studies that could include prisoners as subjects. In a sample of 25, 99 prisoners were participating.

Texas Tech currently has four research studies that could include prisoners. None involves drug testing.

The federal government pays for some; drug companies pay for the rest. It is an important business for UTMB and for universities around the country, and one that is done with only a whiff of outside oversight (see WHIFF OF OVERSIGHT).

The appetite for research subjects is voracious. More than 19 million people a year join clinical trials in the United States, according to one estimate. (No agency tracks the exact number of test subjects.) Drug companies have money. They have ideas for new products. What they lack are research subjects.

A federal study last year found that "rapid enrollment" was "one of the main qualities" companies look for when they hire universities or private investigators to conduct a drug trial. The federal Food and Drug Administration reported, "Sponsors will often explicitly state when contracting with a research site that the site will be dropped if they do not enroll adequately."

UTMB has a source of test subjects unavailable to most other research organizations.

UTMB's Office of Clinical Trials boasts that one of the "special features" available at UTMB that "support clinical research" is the prison hospital, and the tens of thousands of Texas inmates who look to that hospital for medical care.

"There's a long history of this kind of thing," said Dr. David Egilman, a professor in the community health department at Brown University. "Prisoners who join trials get better care. Better care is coercive."

That history travels through Nazi Germany.

The use of prisoners in medical tests is a Frankenstein tale. After World War II, Allied courts found Nazi doctors guilty of conducting macabre tests on concentration camp inmates. Hitler's doctors injected prisoners with diseases. They dunked prisoners in freezing water to see how long they could survive. At a trial in Nuremberg after the war, the Nazi doctors offered a unique defense. They argued that the tests were similar to what Western doctors had done with prisoners of their own.

The allegations were disturbing, and, to an extent, true. U.S. doctors had infected prisoners with a defective cholera vaccine in the Philippines in 1906, killing 13 inmates. More than 500 prisoners at San Quentin State Prison in California between 1919 and 1922 received testicular transplants, some with glands from boars, rams and goats.

The 1947 Nuremberg Code set 10 conditions for using human subjects in medical experiments (see NUREMBERG CODE).

At the heart of the code is a requirement that subjects of medical experiments must be fully informed and their consent must be voluntarily given. Consent must be offered "without the intervention of any element of force, fraud, deceit, duress, overreaching or other ulterior form of constraint or coercion." Because little in prison is done without any element of force, the Nuremberg Code should have ended most research on prisoners.

It didn't, and through the 1960s and '70s, the U.S. public learned that U.S. doctors were conducting experiments on prisoners. In 1972, The New York Times reported that doctors studying the long-term effects of syphilis had allowed black men to suffer from the treatable disease for 40 years. A year later, reporter Jessica Mitford, writing in The Atlantic Monthly, quoted a doctor who extolled the benefits of using inmates in drug tests: "Criminals in our penitentiaries are fine experimental material and much cheaper than chimpanzees."

Commissions formed and congressional committees met in the 1970s. Many recommended ending all research using prisoners. The FDA said doctors who received public money could do only two types of research in prison: They could examine conditions or diseases peculiar to prisons, or they could conduct tests that "have the intent and reasonable probability of improving the health or well-being of the subject."

Otherwise, the federal government said, biomedical research paid for with federal money "shall not involve prisoners as subjects." (see PRISONERS AS SUBJECTS)

By the early 1980s, according to political scientist Allen M. Hornblum of Temple University, "for the most part what had become a controversial and odious research practice was effectively over" except in Texas. A survey in 1975 found that prisoners were still used in medical tests in seven states. Texas was one (see TESTING).

Talking through Plexiglas or over visitor phones, Texas prisoners described why they joined drug trials at UTMB. The stories are the same: The only way to receive what prisoners consider decent medical care was to join a biomedical research trial in Galveston.

James Richard was serving time for lifting a fresh delivery of jewelry from a store in Baytown.

When a blood test showed he had contracted HIV, Richard recalled, "everyone on my block said, 'Don't let them put you on anything on the unit level. They don't know what they're doing.' And we're talking about 40 people with HIV. I went with popular demand. I was scared."

Richard joined a trial that dispensed drugs to control HIV and "had immaculate results," he said. He picked up those drugs at the UTMB prison hospital in Galves- ton, bypassing the prison doctors and pharmacy. "If I could get the (HIV) treatment here that they are giving me in Galveston, without the hassle, then, no, I wouldn't be on the study," inmate Donald Manning said early this year at the Estelle prison unit near Huntsville. "That's why when I first got here I wanted on the study, was to not have to deal with everything here."

"The reason why most people prefer to go to (Hospital Galveston) is because you get better treatment there than at the unit," said Robert Crow, a prisoner at the Darrington Unit near Rosharon and a participant in an HIV drug experiment. "At the unit, they can only do so much. But when you're at the hospital, they're going to listen to you, and they are going to do what they can."

When Cadarell Freeman went back to prison in 1993 for cashing stolen checks, he said: "I knew I had AIDS. I knew I wasn't going to get good care. I thought about it a lot. I knew I might die in prison." Freeman decided, like the others, to become a "guinea pig."

"The study nurses in Galveston told you your care would be better if you got on a study," Freeman explained this year. "That was part of their sales pitch. I wasn't stupid. I knew what I had to do."

Dr. Ben G. Raimer, a UTMB vice president, said the prisoners are mistaken. "We provide the care that is needed, no matter whether the patient is from death row or a regular unit or the free world," he said. "I see no perceptible difference between Hospital Galveston and the units in terms of quality of care. . . . With prisoners, we certainly haven't looked at it as an inducement. In fact, there are downsides from some of these protocols that certainly wouldn't be an inducement to most people."

Inmates complain. They carp about the food, the guards, their treatment. What's striking about these individual accounts of prison health care and UTMB's drug testing program is how closely they match the few assessments made from outside the system.

The prisoners complain about the pill window, where convicts line up to receive their medication (see PILL WINDOW).

They say the pill lines often are long, the windows close before all the medication is distributed, and sick inmates receive the wrong drugs. They say the pill window makes it hard to maintain the strict schedule required to treat HIV.

Others have found the same problems. A survey team from the National Commission on Correctional Health Care found pill lines as long as 1,000 inmates. A doctor reviewing "many clinic notes" as part of a federal lawsuit found that "inmates had problems getting to the pill window on time." Pill window problems may also be helping create a new HIV, one that is resistant to standard drug treatments (see A NEW HIV). Dr. William A. O'Brien is a UTMB doctor who found last year in the first study of its kind that Texas prisoners frequently have a drug-resistant form of HIV. He stated in a university news release that "unique obstacles" in prison contributed to this phenomenon, "including the fact that prisoners must ask for each dose from a pill-dispensing window."

HIV-positive prisoners claimed guards single them out, abusing them and making it difficult for them to maintain their treatment. O'Brien found that prisoners "can be stigmatized" and that this "may discourage these patients from seeking needed medication."

Prisoners said pills they are given through research studies at the UTMB hospital in Galveston are sometimes confiscated and thrown away when they return to their units.

"I saw garbage cans full of study drugs," said Terry Savoy, a former prison system nurse who was fired last year after repeatedly challenging medical practices at the Stiles Unit.

Dr. Steven Jenison, who at the time headed the infectious disease bureau in the New Mexico Department of Health, reviewed prison health-care procedures on behalf of prisoners in a 1999 federal court case. He testified that he was told by a prison clinic staff member "that inmates returning from the UTMB clinic (in Galveston) often have their clinical trials medications confiscated by corrections officers and 'flushed down the toilet.' "

At the Stiles Unit, HIV patients have received their medication crushed in a chalky slurry that prisoners would attempt to gag down, according to several prisoners and prison staff. The practice was stopped this year.

Prisoners said treatment regimens prescribed by UTMB doctors in Galveston were often countermanded by UTMB doctors in the prison units. After reviewing hundreds of medical charts, Jenison testified in 1999 that treatments recommended by specialists in Galveston "are overridden by unit clinic clinicians and unit clinical pharmacists, apparently without direct consultation with UTMB prescribing physicians."

"It's a concern," UTMB's Raimer said. "We're concerned about TB (tuberculosis) drug resistance. . . . Early reports suggested that correctional health-care systems may have had a significant problem with this. Subsequent studies have suggested that may not be true."

Prisoners became aware that problems at the pill windows and in the prison clinics were creating drug-resistant forms of HIV. A prison newspaper carried reports of O'Brien's study.

"I read about the resistance people (in the prisons) have to drugs," inmate James Richard said this year. "Well, this is why we have the resistance. They are causing us to have the resistance. It's the atmosphere we're in."

You may contact Mike Ward at mward@statesman.com or (512) 445-1712 and Bill Bishop at bbishop@statesman.com or (512) 445-3634.

Pill window

In wait for daily doses, inmates and frustrations pile up.

PILL WINDOW

In wait for daily doses, inmates and frustrations pile up Monday, December 17, 2001

Most inmates would prefer to keep a supply of their medicines in their cells to have their pills designated KOP, or "keep on person." The alternative is to pick up the medication at the "pill window," a central office that dispenses medication day by day. The lines at the pill window are often extraordinarily long. Sometimes the pill window closes before all the inmates are served, inmates allege, and when a prison is on "lockdown" and inmates are confined to their cells, medications are distributed haphazardly. The system is particularly hard on the 2,500 inmates with HIV.

"To me, if you're on HIV meds and you're taking them because you want to take them, why do they make it so hard to get 'em?" asked Donald Manning, 38, serving 20 years for forgery at the Estelle Unit just outside Huntsville. The vagaries of the pill window constitute "unique obstacles" to effective HIV treatment, according to a prominent UTMB doctor.

Yet UTMB has purposefully decreased the number of medications given to inmates KOP, in order to maintain tighter control of drugs.

The state auditor found in 1998 that before UTMB took over the majority of prison medical clinics in 1993, "approximately 61% of the medication orders were KOP as compared to 44% currently."

"The result," concluded a health-care consultant hired by the auditor, "has been long and crowded medication lines," exactly as the inmates have complained.

A new HIV

Some convicts back in free world with altered virus strain.

A NEW HIV

Some convicts back in free world with altered virus strain

Monday, December 17, 2001

Texas prisons are releasing men and women with drug-resistant forms of HIV, potentially exposing the community to those strains of the human immunodeficiency virus. One cause of the drug resistance, according to research by the University of Texas Medical Branch at Galveston, is the way UTMB provides medical care in Texas prisons.

A year ago, Dr. William O'Brien announced he had found that "patients in the Texas prison system infected with (HIV) frequently have a drug-resistant form of the virus." The cause of the resistance, O'Brien reported, "is often related to inconsistent administration of medication, and it results in diminished responses to drug therapy."

O'Brien is a renowned doctor at UTMB, and he was the first in the nation to test for HIV drug resistance among inmates. UTMB is in charge of the administration of medication at 80 percent of Texas' prisons. Prisoners' inability to receive consistent doses of medication from the pill window is one cause of the drug resistance, according to a UTMB news release announcing O'Brien's findings. Yet under UTMB's administration, the number of prescriptions given from pill windows has increased by 44 percent. O'Brien said allowing HIV patients to pick up their pills weekly or monthly "would be nice to have."

Meanwhile, O'Brien and UTMB warned in a September 2000 news release that the "prevalence of HIV drug resistance in prisons also may have important implications for the community at large. . . . Most of these incarcerated patients will be released at some point and will return to the community." Controlling HIV drug resistance in the prisons, the news release said, "will help to limit the spread of drug-resistant HIV in the general population." The virus is transmitted from one person to another through body fluids. There is no indication that the drug-resistant strain of HIV in Texas prisons has been transmitted to people outside prison.

Whiff of oversight

Healing or harming, medical tests rarely held up to scrutiny.

WHIFF OF OVERSIGHT

Healing or harming, medical tests rarely held up to scrutiny Monday, December 17, 2001

Healing or harming, medical tests rarely held up to scrutiny "Here's the problem you face and I face," said William Winslade, an attorney and professor in the medical humanities program at the University of Texas Medical Branch in Galveston.

"Are these stories that surface (about harmful drug tests) the tip of the iceberg, or are they the unusual event? I don't have the sense there is a lot of cover-up of people being harmed. But I don't know that. I don't think anybody is in a position to pontificate about how big the problem really is because nobody's collected the data." When it comes to drug testing in the United States, there are questions without answers. How many tests are being conducted? By whom? How many people are subjects in these experiments? Who is paying? How many people are hurt? Do some die? How many?

Nobody knows.

Up to 19 million people a year take part in medical tests. UTMB alone conducts about 1,600 medical trials a year on an uncertain number of subjects. Universities have boards made up primarily of university employees who oversee these tests. The boards do not inspect research facilities, nor do they inspect how the research is conducted. The boards review paper. They oversee forms. In Texas, their deliberations and their decisions are secret. A federal General Accounting Office study in 1996 found that some of these boards spent only one or two minutes reviewing individual research projects.

The federal Office of Human Research Protections is the agency charged with overseeing research paid for by the federal government. From 1990 to 1996, the agency made a total of 18 on-site inspections of drug tests. The federal Food and Drug Administration occasionally inspects these university boards, making on average 200 visits a year to the estimated 3,000 to 5,000 boards. The FDA found in 1999 that only 19 percent of the university boards were working without a deficiency.

The FDA inspected only 468 of nearly 14,000 clinical investigators in 1999. The FDA doesn't provide day-to-day oversight; rather, it looks at trials that are finished. In those inspections, the FDA found that half of the medical trials had some deficiency in their research procedures. Drug testing is virtually unregulated compared with other industries. The federal government, for example, employs 663 men and women to inspect 2,375 underground coal mines. A coal miner can expect to see an inspector four times a year.

Since 1966, law has required federal agents to make regular and unannounced inspections of the animals kept for medical research purposes. The U.S. Department of Agriculture made 1,816 such inspections in 1999, more than four times the number of inspections of medical research experiments. Although the federal government has no idea how many people are enrolled in research trials, the Agriculture Department reports that 70,541 dogs, 288,222 rabbits and 201,593 hamsters were used in research trials in 1998.

"There are unannounced visits to animal experiments; there are no unannounced visits to human subject research projects," said Adil Shamoo, a University of Maryland research scientist. "It's unbelievable that animals for 34 years are regulated and human beings are not. To me, it's just shocking."

Testing

Vulnerability of prison life ensures captive audience for experiments.

TESTING

Vulnerability of prison life ensures captive audience for experiments Monday, December 17, 2001

HUNTSVILLE Thirty years have passed, but Ray Hill remembers well the Octobers he spent inside a Texas prison.

Guards would stop by his cell and offer him a $50 credit at the prison commissary if he would help test an experimental flu vaccine. The credit was a prison fortune in those days.

"Fifty bucks to get sick? No way," Hill remembers thinking the first year. "I didn't take it. Everybody else did. I caught the flu.

"A year later, I took the shot and the 50 bucks. I figured if I was going to get the flu anyway, I might as well have the commissary."

Through the years, according to prison archives and longtime corrections officials, Texas convicts have participated in an assortment of drug tests and other research, including one in which they provided urine for a cancer study.

Today, the payments are gone. They were never legal under federal law. But the testing continues.

Hill, 61, now a Houston prison activist who did time for burglary and left prison in 1975, insists that inducements and coercion are still a problem in Texas prisons.

"Prison is vulnerability. And in a situation . . . with these protocols, it makes them coercible to the max," he said. "Ignoring that there is a problem is like trying to ignore an elephant in the drawing room."

Prisoners as subjects

As ethical debate simmers, inmate testing goes on.

PRISONERS AS SUBJECTS

As ethical debate simmers, inmate testing goes on Monday, December 17, 2001

As the HIV epidemic spread in the 1980s, the only way patients could gain access to the latest medications was to enter clinical trials. At the same time, the nation's war on drugs was shipping thousands of intravenous drug users to prison. Getting tough on crime meant filling prisons with HIV-positive inmates. By 1992, the incidence of AIDS among men in prison was five times higher than among the general population. Drug companies weren't the first to ask that prisons be opened to clinical trials. HIV activists argued that convicts had a right to the same life-extending drugs available in free-world clinical trials.

"The drug companies don't need prisoners," said Dr. David Egilman, a professor in Brown University's community health department. "They can do these tests in the Third World just as easily. The reason they are in prisons is that all the people doing the research are liberals. Some of them are gay. These progressives are trying to use this research to get better AIDS care to the prisoners."

There was a cultural split within the research community. AIDS activists saw one kind of genocide. Critics of prison drug testing saw the potential for another. Soon, the AIDS epidemic inside prisons overpowered the memories of the Holocaust that had fueled opposition to drug testing in prisons. At a meeting in late 1999 at Brown on clinical trials in prison, doctors from the University of Texas Medical Branch in Galveston were among those who made presentations.

The meeting had unintended consequences. HIV researchers in prisons mixed with those who opposed almost all medical research in prison. The combination was explosive.

Egilman and author Allen Hornblum, who wrote a book on medical testing on inmates, sat through the sessions amazed at the extent of the research taking place in prison and at how little doctors at the conference seemed to pay attention to the prohibitions against prisoner research set forth by the Nuremberg Code. "They were so unethical, they didn't think twice about any of this," Egilman said.

Egilman filed a complaint with federal authorities. Several months later, the federal agency that oversees research trials that use public money challenged medical tests involving prisoners at some of the nation's foremost research institutions: Yale, Brown, the University of Florida and the University of Texas Medical Branch in Galveston.

Nuremberg code

Rules on medical testing adopted during Nazi trials.

NUREMBERG CODE

Rules on medical testing adopted during Nazi trials Monday, December 17, 2001

A summary of the guidelines established by military tribunals:
1. The voluntary consent of the human subject is absolutely essential.
2. The experiment should not be random or unnecessary and should yield fruitful results for the good of society.
3. The experiment should be designed and based on results of animal experimentation.
4. The experiment should avoid inflicting unnecessary physical and mental suffering and injury.
5. No experiment should be conducted if there is a reason to believe that death or disabling injury will occur, except in experiments in which the experimental physicians also serve as subjects.
6. The degree of risk taken should never exceed the humanitarian importance of the problem to be solved.
7. Adequate facilities and preparations should be made to protect the subject from even the most remote possibility of injury or death.
8. The experiment should be conducted only by scientifically qualified personnel.
9. The subject may bring the experiment to an end if he or she thinks physical or mental continuation is impossible.
10. The scientist in charge may terminate the experiment at any stage. 1946 Associated Press
War-crimes trials of Nazi doctors led to the establishment of rules to protect patients in future medical experiments.