The department's Office for Human Research Protections has asked the Institute of Medicine, an advisory group that is an arm of the private-sector National Academies, to determine whether 1970s-era regulations "are overprotecting a population that would greatly benefit from research," said Julia Gorey, a policy analyst in the office who oversees federally funded prison-related research. "Many people are arguing that it is too protective, and that these prisoners have the right to participate in research."
Once the institute completes the review, Gorey said, it is likely that the OHRP will begin the formal process of writing new regulations. The review is one piece of a broader effort to change the rules that govern research involving the nation's 2.1 million prisoners held in a variety of maximum-, medium-, and minimum-security facilities.
Already, the HHS Advisory Committee on Human Research Protections, whose members are university researchers and industry advisers, has sent a letter to Secretary Mike Leavitt proposing changes that it says would help researchers and institutional review boards. Federal patient-protection rules require that university chiefs -- whose institutions do most of the federally funded medical research -- appoint these review boards to oversee experiments before they come under federal review.
Over time, the protection rules need to be "totally amended," advisory committee Chairman Ernest Prentice told National Journal. Prentice is a genetics professor and the associate chancellor for academic affairs and regulatory compliance at the University of Nebraska Medical Center. "We feel as though the regulations are not compatible," he said, "with the current penal system in the U.S., which has changed significantly since the 1970s."
In fiscal 2003, Prentice's university received $96 million in federal funds and $14 million in commercial funds for a variety of research projects, according to the National Science Foundation.
Proponents of changing the regulations say that, for one thing, new rules could allow more social-science research aimed at advancing prison reform. One supporter of new regulations is Alvin Bronstein, a New York lawyer who helped found the American Civil Liberties Union's National Prison Project, and who also serves as a pro bono attorney and advocate for sick inmates. To get reform, he said, "we just have to get enough evidence to sell it to the policy makers."
Rules changes could also help alleviate the shortage of patients eligible to serve as subjects in pharmaceutical testing. Such tests are critical for biotech companies and university researchers because the Food and Drug Administration requires that a drug be shown to be reasonably safe and at least partly effective before licensing its use. Companies also conduct tests to find new uses for existing drugs, and to showcase drugs to doctors and insurance companies.
The search for test volunteers is so intense that a global "contract research" industry has emerged to recruit and manage cohorts of patients for biomedical testing. The revenues in this new industry, which includes many universities, grew from $1.6 billion in 1993 to $10.4 billion in 2003, according to Thomson Centerwatch, a Boston-based market-research firm. In 2003, the industry earned $5.7 billion to recruit and manage 3.6 million patients in the United States. Drug companies and universities also conduct many other tests on their own. But the practice of using prisoners in biomedical testing has a sordid past. From the 1940s to the 1970s, many prisoners were subjects in university- and company-run research protocols, often with no protections from, or treatment for, debilitating side effects.
By 1972, government officials estimated that more than 90 percent of all new pharmaceuticals were being tested on prisoners, according to a 1995 report by the Energy Department's Advisory Committee on Human Radiation Experiments. By the mid-1970s, such testing had declined, as citizens and legislators recoiled from news about abuses.
From 1951 to 1974, for example, prisoners at Holmesburg Prison in Philadelphia were paid to participate in experiments by University of Pennsylvania researchers on behalf of federal agencies and pharmaceutical companies, including the Defense Department, Dow Chemical, and Johnson & Johnson, according to the 1998 book Acres of Skin, by Temple University professor Allen Hornblum.
In 2000, almost 30 years later, 298 prisoners sued for damages, but the case was thrown out because the statute of limitations had expired. "This was a business that was raking in millions of dollars, [and] nobody cared about the convicts," said New York dermatologist Bernard Ackerman, who said he helped run some experiments -- including a search for a dandruff treatment -- when he was a student at the University of Pennsylvania.
The reports about Holmesburg and other prisons emerged at about the same time the public learned in 1972 about the decades-long experiment on poor blacks in rural Tuskegee, Ala. Starting in 1932, the federal Public Health Service and the Tuskegee Institute, a historically black college, had enrolled 399 men in an experiment intended to chart the course of their syphilis until they died. For many years, the doctors prevented treatment of the men's disease, even after a cure was developed in 1947.
After these controversies, the government introduced new prisoner-protection regulations for federally funded research, but failed to complete planned regulations on private-sector research.
Since 2000, the Office for Human Research Protections has approved roughly 430 HHS-funded studies involving prisoners, Gorey said. On average, 100 prisoners participate in each study. One-quarter of the studies are biomedical tests, she said, and the others are "social-behavioral" studies investigating such issues as treatments for drug addiction and inmates' reintegration into the community.
Government officials and academics say they don't know how many prisoners are enrolled in commercially funded tests. "There is a lot out there that we don't see, and [that the HHS] regulations have no bearing on," Gorey said. The FDA says it does not have data on the number of inmates participating in medical experiments.
But in 2000, Gorey's office temporarily froze more than 200 research projects managed by the University of Texas Medical Branch in Galveston, according to a September 2000 report in The Austin American-Statesman. This action chilled the entire inmate-research sector, said Brown University professor Annie De Groot, who also owns a vaccine-research company and edits the Infectious Diseases in Corrections Report. Many of the frozen experiments were never restarted, and many universities and companies halted other private-sector prison experiments, said De Groot, who advocates additional research in prisons.
Under current federal rules, biomedical research on prisoners must offer a direct benefit to the prisoner and must pose a risk only minimally higher than that faced by a sick person outside the trial. Special approval is needed for experiments in which prisoners face greater risk or fewer benefits. Social-behavioral research does not have to directly benefit a participating prisoner, but these studies generally pose less risk than biomedical research. All prisoners must give informed consent, without the promise of financial gain.
Some elements of the rules are "almost paternalistic," Gorey contended. "We're stuck with the default position that intentionally made it very, very difficult to do any research with prisoners."
De Groot and other advocates say the rules should be changed because prisoners have a right to enroll in biomedical and social-science research, because the drugs will aid prisoners, and because the research will help identify useful drugs and penal practices that can benefit society, patients, and the prisoners.
Also, De Groot said, "we're interested in getting trials because we see it as an opportunity to improve the standard of care overall" for inmates. "If you open prison doors, you're getting better physicians in place, and you get better treatment for prisoners. Right now, it is pretty abysmal." Bronstein said that inmates can be protected from possible coercion by the use of outside experts to serve as advocates.
The debate over prison testing is dominated by political liberals. Those who support prison tests argue that prisoners will gain better health care and that they have the right to choose whether to join a test. But other liberals say the research allows powerful professionals and corporations to exploit powerless prisoners.
Opponents of prison research say that actual practice disproves the claims of benefits to prisoners. Inmates, critics say, are poorly educated and usually will grasp at any chance for a benefit or a respite from jailhouse pressure. "They are not really free to exercise choices," said Gwendolyn Chunn, president of the American Correctional Association in Lanham, Md. Prison testing should be avoided, she said, because "the potential for abuse would be too great."
Moreover, most trials fail to produce significant benefits to the participants, partly because many candidate drugs don't work, said David Egilman, a community health professor at Brown University, who also urges more health care funding for inmates.
Researchers, biomedical companies, prison-management companies, and corrections agencies stand to gain revenue from research, critics charge, even when it yields no medical benefits to the prisoners. "Each prisoner can [be] a profit center," Egilman said. "If there is money involved, there is no possibility that it won't end up corrupt," Ackerman asserted. Instead of prisoners, "let them use medical students," he said. "Let them use professors, too."
Opponents of prison research also say that university and company researchers who violate the patient-safety rules aren't punished. Gorey's OHRP "is not even a paper tiger," argued Vera Hassner Sharav, the president of the New York-based Alliance for Human Research Protection, which opposes prison testing.
The Institute of Medicine panel working on the review is expected to report back to HHS next year. But opponents say it is stacked in favor of more prison research. Sharav said that the Institute of Medicine "is no more a disinterested objective entity of scholars than is the National Institutes of Health or the FDA."
The private-sector IOM's 16-member panel consists of university researchers and professionals active in the prison sector or in the social sciences. "We try to minimize serious biases, and we try to balance biases," by choosing a variety of different panelists and by excluding people committed to their biases, said Clyde Behney, IOM's deputy director.
The institute's reliance on professional expertise does create a danger of minimizing the public's input, so IOM executives make sure to invite outsiders to testify, Behney said. The panel has heard testimony from Sharav and Hornblum.
Lawrence Gostin, who chairs the panel, said, "The IOM has very rigorous standards to prevent conflicts of interest." Gostin is a law and ethics editor of the American Medical Association's leading medical journal; he is also a professor at Georgetown University and at Johns Hopkins University, which is the leading recipient of federal biomedical research funds.
Gostin says it is too early to predict what the panel will decide. "You want to make sure you provide as much safety and protection for the rights and health of people in the prison system," he said, "and also facilitate high-quality research."