by Gregory Dober
"It is the duty of the doctor to remain the protector of the life and health of that person on whom clinical research is being carried out." Declaration of Helsinki
In June 2006, the Institute of Medicine (IOM) issued a report on simplifying the current federal regulations for conducting medical research in prisons, which included recommendations to increase the use of prisoners as test subjects. The IOM's "definition of simplicity" is approximately two hundred pages long while the current regulations, included in the report, account for approximately four pages of the same font size, type and page length.
An IOM Committee was formed in 2005 to investigate possible changes to the federal policies regarding biomedical research in prisons. Those regulations, codified at 45 C.F.R. 46, Subpart C (Research and Prisoners), are intended to protect prisoners as subjects in biomedical and behavioral research. The current regulations restrict researchers to four basic categories of research when using prisoner test subjects: 1) studies involving causes and effects of incarceration, 2) the prison as an institutional structure, 3) conditions affecting prisoners as a class, and 4) research on practices that have the intent and reasonable probability of improving the well-being of the subject. All research studies must ensure minimal risk to the incarcerated test subjects.
Still Cheaper Than Chimps
In her 1973 book, Kind and Usual Punishment, Jessica Mitford said a researcher had confided to her that prisoners are "... fine experimental material ... and much cheaper than chimpanzees." Thirty years later in 2003, the Institute for Laboratory Animal Research (ILAR), which includes among its supporters many pharmaceutical companies and governmental agencies, reported the following dilemma in the Institute's journal. The article, Demands for Rhesus Monkeys in Biomedical Research: A Workshop Report, stated, "... scientists are facing a shortage of nonhuman primates available for biomedical studies. Through the mid-1970s, the rhesus macaque could be readily imported from India, and the scientific community grew dependent on access to this laboratory animal. Today, however, rhesus macaques can no longer be imported from India. Although U.S. breeding colonies are operating at peak capacity, scientific demand for these and other nonhuman primates exceeds the available supply."
Concerned that shortage of nonhuman primates could seriously impede scientific progress, two components of the National Institutes of Health (NIH), the Office of AIDS Research (OAR), and the National Center for Research Resources (NCRR), have taken a lead role in addressing this issue.
High costs, a shortage of primates and intimidation from animal rights activists have caused some researchers to move their biomedical laboratories to countries more conducive to research using nonhuman primates. Based upon the ILAR report, Ms. Milford's observation of thirty years ago may not be so outrageous. Currently, those who oppose using nonhuman primates in research garner a more influential legislative lobby and more public sympathy than those who oppose the use of prisoners in medical experiments.
Before reviewing the IOM's proposed changes in prison research regulations, I wanted to satisfy a curiosity and determine if prisoners are in fact cheaper than chimpanzees. Due to space and time constraints I did not calculate financial figures; however, based upon current regulations, prisoners still appear to be less costly. The Guide for the Care and Use of Laboratory Animals, funded by the National Institute of Health and other government agencies, is approximately one hundred and twenty pages in length. A review of the Office of Human Research Protections, IRB Guidebook, reveals that approximately four pages are dedicated to prisoners as research subjects.
In 1966, Congress passed the Animal Welfare Act (AWA), 7 U.S.C. § 2131. The act, and subsequent regulations such as the Improved Standards for Laboratory Animals Act (1985), include such obligations as requiring researchers to provide primates with a "balanced diet of wholesome food," "environmental enrichment" such as toys and regular interaction with other primates, "minimum requirements ... for a physical environment adequate to promote the psychological well-being of primates," and "clean and structural housing" with suggested dimensions. In the suggested enclosure dimensions, two 66-pound apes are required to have more square footage than two human prisoners who share a typical prison cell.
Facilities that house primates must have a full-time veterinarian located on the premises and must establish a program of regular veterinarian care, including medical examinations. The USDA Animal and Plant Health Inspection Service is allowed to make regular and unannounced visits to research facilities. Corrective action for violations can include confiscation of the animals and/or civil penalties imposed on the researcher. However, no such uniform laws or regulations exist that give prisoners enforceable rights related to amount of living space, diet, medical care, living conditions or psychological well-being.
While a need exists for the protection of research animals, it is troubling that the regulatory requirements for working with lab animals are apparently more burdensome and costly than experimentation on prisoners. If a researcher can read and understand the approximately two hundred pages of the IOM report or the hundreds of pages of animal welfare requirements, what seems to be the difficulty in understanding the four pages of current federal prison research regulations?
Evolution Of Biomedical Research Codes
It was after the experiments conducted by Nazi researchers on concentration camp prisoners during World War II that a formal code of research ethics was created. Subsequently, various international and national codes, laws and regulations have been implemented with the intent to guide proper ethical conduct relative to biomedical research studies.
In 1947, the Nuremberg Code established a set of written principles in response to human experimentation by Nazi doctors during the Second World War. The Code addresses such important principles as absence of coercion, properly formulated scientific experimentation, and informed consent. In response to the dissemination of the Nuremburg Code, the World Medical Organization in 1964 developed the Declaration of Helsinki, which reiterated many of the significant principles embodied in the Code.
On July 12, 1974, President Nixon signed the National Research Act. This law created a commission to identify basic underlying ethical principles to be used in conducting biomedical research. In 1979 the results and recommendations of the commission were published in the Belmont Report, which established ethical guidelines for informed consent, beneficence, justice, assessment of risks and selection of human test subjects.
Notably, the Belmont Report, which addressed human research subjects, was published thirteen years after the AWA was enacted to protect animals.
The National Research Act required codified regulations to protect human subjects during medical research in the United States. This resulted in 45 C.F.R. 46, Regulations for the Protection of Human Subjects in Biomedical and Behavioral Research, which established standards for matters such as informed consent, selection of research subjects and Institutional Review Boards (IRBs). In 1978, federal regulation 45 C.F.R. 46, Subpart C was issued specifically for the protection of prisoners as vulnerable subjects in biomedical and behavioral research. Two years later the Food and Drug Administration (FDA) adopted 21 C.F.R. 50.44, which prohibited the use of prisoners in Phase 1 clinical drug trials.
In 1991, 45 C.F.R. 46, Subpart A, Basic HHS Policy for the Protection of Human Research Subjects, became known as the "Common Rule." Seventeen federal agencies agreed to adopt the principles of the regulations and consistently apply them to subjects in all federally funded research.
However, as the IOM report notes, only three federal agencies have chosen to follow the more rigid regulations for protection of prisoners in medical studies. These three agencies are the National Institute of Health (NIH), Central Intelligence Agency and Social Security Administration. Since the NIH distributes most of the nation’s university research grants, those institutions must abide by the federal regulations on prisoner research. Ironically, before adoption of the regulations it was the CIA and its proxy, the Department of the Army, that carried out various experiments on prisoners, ranging from toxic chemicals to mind altering drugs.
In 2003, Karena Cooper, a representative of the Office for Human Research Protections (OHRP), made a presentation that addressed the difficulties encountered by researchers in understanding and complying with the current prison research regulations. OHRP requested guidance on the regulations, including issues of adequate inclusion or exclusion of prisoners as subjects, appropriate background for a prisoner representative on an IRB, and the challenges of working within the four categories of research permitted for prisoner test subjects. A subcommittee was formed to investigate the OHRP request. The subcommittee presented a list of recommendations and commissioned the IOM to study the recommendations and issue a report regarding changes to existing prison research regulations. The report was finalized and published in June 2006.
The Sordid Legacy Of Prison Research
The IOM report states, "Advances in ethical thinking about protectionism suggest a new regulatory model. In particular, the committee rejects strong protectionism because it discounts the notion that researchers can be trusted to act virtuously in the protection of the subject." In past decades, however, improper research in prisons has seemed to be the norm despite ethics regulations.
Following the issuance of the Nuremburg Code, biomedical researchers during the period of the 1940s through the 1970s used prisoners as a primary source of research subjects. In 1962 the FDA began requiring pharmaceutical drugs to undergo three human clinical trials before approval; as a result, from 1962 to 1980, when the regulations were changed, up to 85% of Phase 1 clinical trials were performed on prisoners.
Many hazardous research trials were conducted on prisoners without proper informed consent or minimal risk to the test subjects. Two high profile cases were the Oregon and Washington State prison radiation studies and the non-therapeutic biomedical research studies at Holmesburg Prison in Philadelphia. [See: PLN, March 1999, p.1].
In the early 1960s, Dr. Carl G. Heller and Dr. C. Alvin Paulsen received $1.6 million in funding from the U.S. Atomic Energy Commission to perform radiation studies on the male reproductive system. The testing consisted of irradiating hundreds of prisoners’ testicles with large doses of radiation. The prisoners were paid $5 a month and $10 per biopsy to be subjected to these experiments, plus $100 at the conclusion of the study.
High-dose radiation experiments continued on prisoners until 1970 in Washington and 1973 in Oregon. As a result of this research the prisoner test subjects suffered severe burns, testicular inflammation, painful biopsies and bleeding into the scrotum. The informed consent forms signed by the prisoners did not mention an increased risk of testicular cancer, radiation poisoning or other long-term effects. In a 1976 deposition, Dr. Heller admitted he "didn't warn them of all the dangers because I didn't want to frighten them." At least four prisoners who did not get vasectomies reportedly fathered children with birth defects after their release.
In 1995 the Clinton administration and universities involved in radiation research experiments issued an apology to the test subjects. Regardless, an unapologetic Dr. Paulsen maintained that no wrong had been done. In fact, a follow-up program was considered subsequent to the irradiation experiments in Washington that would have provided medical exams to the prisoner test subjects at two or three-year intervals. Dr. Paulsen criticized such exams, saying they were "not indicated for medical reasons." He also questioned the legality of contacting the former prisoner participants and opined that former subjects would want to “disassociate themselves from the prison experience.”
Questioned about his prison research, Dr. Paulsen said, "If our work was unethical then you'd have to say that all the committees that approved it in those days were completely unethical, and so, no, that’s not true. But I don't want to talk about it any more." The U.S. Dept. of Energy, commenting on the Washington and Oregon prison irradiation studies, called them ethically flawed "even by the standards of the time."
Allen M. Hornblum, in his 1998 book Acres of Skin [distributed by PLN, see page 46 for ordering details], documented the longest known case of prison experimentation in the United States. The studies were conducted at Holmesburg Prison in Philadelphia. From the 1950s through the 1970s, Dr. Albert Kligman, then a young and aspiring dermatologist at the University of Pennsylvania, conducted various experiments on inmates. His studies eventually led to the discovery and patent of Retin-A, an anti-acne cream. In addition he performed hundreds of experiments on prisoners for Johnson & Johnson, Dow Chemical, the U.S. Army and his own corporation, Ivy Research.
At Holmesburg, Dr. Kligman's research trials varied from the innocuous to the mutilating and dangerous; they ranged from the use of lotions and creams to poisonous chemicals and radioisotopes. He was paid $10,000 by Dow Chemical to test the effect of dioxin, an ingredient in Agent Orange, on prisoners’ skin. Many of the biomedical trials conducted at Holmesburg had research protocols that were neither of a therapeutic nature nor of benefit to the test subjects. Some resulted in lasting injuries.
In 2006, after the IOM committee issued its report, Dr. Kligman was asked by New York Times reporter Ian Urbina for his opinion on revising the federal regulations to increase the use of prisoners as research subjects. "My view is that shutting the prison experiments down was a big mistake," Dr. Kligman said. He cited his breakthroughs for the development of Retin-A and ingredients for many of the topical creams used to treat poison ivy, and stated his belief that such experiments resulted in overwhelming benefits to the public. "I'm on the medical ethics committee at Penn," Kligman noted, "and I still don't see there having been anything wrong with what we were doing." [See: PLN, Oct. 2006, p.14]. Which is not surprising, considering that his experiments generated overwhelming personal benefits. In 2000, Dr. Kligman donated $2 million to create fellowships for graduate students at Penn State University, money that he likely made, in part, from his profitable prison studies.
Some in the research community claim that cases such as Drs. Kligman, Paulsen and Heller, while infamous, are isolated and rare. To test that hypothesis I went to a medical library and randomly pulled journals from the "gilded era" of medical research. Within forty minutes I found numerous articles involving prisoner test subjects. John R. Neefe and Joseph Stokes, Jr., et al. published one of these not-so-famous studies in the March 1947 issue of the Journal of Clinical Investigation. The authors describe the blending of hepatic liver and hepatic feces in a Warring Blender to create "liver suspension in sterile beef heart infusion broth" and "feces pool." The study "volunteers" were male prisoners with no history of jaundice or hepatitis from the New Jersey State Prison in Trenton. The researchers described the inoculation of these volunteers: “On each of 4 successive days, 5 ml. of feces pool ... was administered in chocolate milk to each of the five volunteers. ...
The five men of the third group, each ingested in milk, 20 ml. of liver suspension .... Experiments such as these, infecting otherwise healthy people, with contagious diseases may well have helped spread hepatitis and other diseases among the IV drug using and prisoner population where it is currently concentrated.
In other early experiments, Harvard biochemist Edward Cohn injected 64 Massachusetts prisoners with cow blood in a 1942 study sponsored by the U.S. Navy. More than 400 Illinois prisoners were used as test subjects in malaria experiments conducted by Dr. Alf Alving of the University of Chicago Medical School between 1944 and 1946; the prisoners were not told they were being infected with malaria. One prisoner died and two developed hepatitis in a 1944 study conducted by Captain A.W. Frisch at the state prison in Dearborn, Michigan. In 1950, 200 female prisoners were injected with viral hepatitis in a University of Pennsylvania experiment. Two years later, Chester M. Southam at the Sloan-Kettering Institute injected live cancer cells into Ohio State Prison convicts to examine the progression of the disease. Half of the test subjects in Southam's NIH-sponsored study were black, raising concerns of racism.
Time magazine reported in July 1963 that a drug trial program at the Oklahoma State Penitentiary was being "drastically overhauled." The prison's medical director, Dr. Austin R. Stough, and his partner, Dr. Cranfill K. Wisdom, were paid an estimated $300,000 annually by pharmaceutical companies to use prisoners as test subjects. They also ran a profitable prison blood plasma operation; a similar program in the Arkansas prison system was the subject of an award-winning 2005 documentary called "Factor 8."
In 1967, sixty-four California prisoners were paralyzed with succinylcholine, a neuromuscular agent that restricts breathing. Succinylcholine has since been used in lethal injection protocols. When several of the prisoners refused to participate in the experiment, researchers were given permission to inject the recalcitrant prisoners against their will.
Radionuclide tests using prisoner subjects were sponsored by the University of Utah "blood samples were taken from the prisoners, exposed to a radioactive form of phosphorous, and then re-injected." The university conducted 13 human radiation experiments between 1954 and 1972 that involved 640 people, almost half of them prisoners. Doctors involved in those studies later wrote research papers indicating that irradiated phosphorus contributes to some forms of bone cancer.
Many of the above examples, and other egregious experiments performed on children, pregnant women, the mentally disabled, military personnel and the uninformed general public, are detailed in Andrew Goliszek's 2003 book, In the Name of Science. It is apparent that such studies were not so rare or isolated, nor ethical or humane. Note that the Neefe and Stokes hepatic feces study was conducted contemporaneously with the high profile Nuremburg trials, when American prosecutors were seeking death sentences against Nazi doctors accused of unethical medical research.
Ironically, in 1971 the Children’s Hospital of Philadelphia named the Joseph Stokes, Jr. Research Institute after its former physician-in-chief and co-author of the hepatic prison research study. During the Nuremberg trials the Nazi doctors cited the University of Chicago's prison malaria experiments to defend their own biomedical testing on concentration camp prisoners. Perjured testimony by American prosecutors disclaimed any similarity between contemporaneous Nazi and American experiments on prisoners. 16 of the 23 doctors were convicted and seven hanged.
Drs. Kligman and Paulsen, in their subsequent comments regarding their research protocols, have shown no apparent remorse or responsibility for the pain and suffering they inflicted on prisoner subjects during or after their experiments. Both researchers continue to maintain their "ethical innocence." Revising or expanding prison research regulations will not eliminate immoral or unethical researchers and their behavior, and if history is a predictor of human proclivity then the OHRP must embrace " not reject" strong protectionism on behalf of incarcerated test subjects.
This is true because questionable clinical trials involving prisoners are not relegated to the distant past. In 1997, Stanford University sponsored psychiatric drug tests on 61 juvenile prisoners at a California Youth Authority facility in Stockton. The test subjects were 14 to 18 years old and had committed violent crimes; they were given doses of Depakote, a drug used to control epileptic seizures. The study was conducted without the knowledge of the CYA director or the agency’s legal office, and may have violated a state law that barred most medical research involving prisoners. Consent forms were mailed to the juveniles’ parents; if the parents didn’t respond within 30 days, the CYA gave consent on their behalf. The experiment had been approved by Stanford’s Human Subjects Committee. [See: PLN, Dec. 1999, p.11].
Further, a March 19, 2000 article in the St. Petersburg Times detailed pharmaceutical trials involving HIV-positive Florida prisoners. State prison officials, cautious about such research, created a watchdog committee to protect the prisoner test subjects; however, the committee was disbanded and replaced months later with a panel composed almost entirely of prison employees. The prison system’s director of health services, Dr. David L. Thomas, a proponent of the drug trials, previously had been listed as a consultant and speaker for two pharmaceutical companies that produced anti-HIV medications used in the research studies. Both companies stated they had paid him honoraria for his advice on AIDS-infected prisoners. The Florida prison studies were funded by NIH, Glaxo Wellcome, Merck & Co., and Pharmacia & Upjohn, Inc.
“I’m sure you will find someone, whether it’s a prisoner rights advocate or a so-called expert on medical ethics, to criticize us, especially on the issue of informed consent,” said Florida Dept. of Correction spokesman C.J. Drake, who referred to questions from a Times reporter as “nitpicking issues of secondary importance.” Prisoners who volunteered to participate in the drug trials cited better healthcare and amenities at the treatment unit such as air conditioning and comfortable shoes as inducements. One prisoner who was interviewed for the article was receiving a placebo medication, but upon questioning said he didn’t know what a placebo was. [See: PLN, April 2001, p.6].
The Commodification Of Test Subjects
Today, research subjects are a valuable “commodity.” A commodity needs to be affordable, available and useful. Currently, like any commodity in short supply, research subjects are not affordable or readily available.
Primarily because the pharmaceutical industry refuses to pay Americans the amounts of money it takes to entice them to undergo dangerous, potentially lethal medical experiments. To understand why trial subjects are needed and valuable to researchers, we must examine the size of the industry and current trends as well as the seriousness of competition for drug revenues.
According to a report released in 2007 by the Kaiser Foundation, a private non-profit foundation that focuses on major healthcare issues, prescription drug sales in the U.S. totaled $200.7 billion in 2005. This reflects an increase in sales of five hundred percent from 1990. Global pharmaceutical sales for 2006 were $643 billion, according to IMS Health.
In 2006 the drug industry was listed as the second most profitable industry, with a 19.6% profit margin. That compares to an average 6.9% profit margin for all Fortune 500 companies in the same year. The U.S. Dept. of Health and Human Services is predicting that domestic prescription drug sales will increase to $497.5 billion by 2016.
Pharmaceutical companies spend billions of dollars annually on drug research and development; the time between a drug’s initial development and its approval can take a decade or more, thus the stakes are high.
It is not unusual for drug companies to also own subsidiaries in the cosmetics industry. For example, industry labs have developed and improved such “vanity” items as makeup, lipstick and hair conditioners.
However, over the past two decades drug companies have been directing more resources to the advancement of “lifestyle” pharmaceuticals. Such “lifestyle” drugs treat erectile dysfunction, baldness, wrinkles and obesity. It is debatable whether the industry has followed consumer demand or created consumer demand through the advertising of such products.
In 2005, drug company direct-to-consumer advertising was $4.2 billion. In comparison, 1996 consumer drug advertising was $800 million. Such advertising may account for a rapid sales jump for Cialis, an erectile dysfunction (ED) drug made by Eli Lilly. Cialis sales increased by 35% from 2004 to 2005. It is estimated that revenues from the top three ED drugs accounted for $3 billion in 2006. Advertising expenditures for Pfizer’s ED drug, Viagra, were estimated to be in excess of $400 million in 2006. The demand for lucrative lifestyle drugs has created a greater demand for testing the safety and efficacy of such medications, which requires more research subjects.
Competition among drug companies for an increased share of drug revenues is fierce. So fierce that incentives are needed to allocate a company’s resources to develop less profitable treatments for less common diseases.
For instance, the industry is offered government incentives to produce drugs for these so-called “orphan diseases,” such as Lou Gehrig’s disease and Tourette syndrome. The NIH Office of Rare Diseases (ORD) defines a rare disease as a condition or disease afflicting less than two hundred thousand people in the United States. The ORD estimates that twenty-five million people suffer from rare diseases in the U.S. alone. Due to the high cost of seeking cures for these illnesses, Congress enacted the Orphan Drug Act (ODA) in 1982. Two of the chief incentives for the drug industry are tax credits and market exclusivity. The ODA created additional incentives to produce orphan drugs by granting the manufacturer a seven-year marketing exclusivity provision. During this seven-year period, the FDA will not allow another company to market a drug for the same use.
Unfortunately the ODA has been used in ways that the original legislators never intended, to generate large profits and revenues for the drug industry. Shortly after the adoption of the ODA, a controversy ensued regarding the drug azidothymidine (AZT), an anti-viral drug for the treatment of AIDS. In 1964, AZT was synthesized under a NIH grant to the then National Institute of Cancer (NIC) for the treatment of cancer. In essence, the American taxpayers provided the funding for the drug’s development. Because AZT had a low efficacy and high side effects in cancer trials, it was not marketed for cancer treatments. In 1985, the NIC, recognizing the anti-viral qualities of AZT, sold the drug to Burroughs-Wellcome, now known as GlaxoSmithKline, for $80,000. Four years later, when the drug was shown to have efficacy with AIDS patients, Burroughs-Wellcome filed for orphan drug status of AZT for the treatment of AIDS. At that time only forty-five thousand AIDS patients were diagnosed.
AZT was originally approved under the ODA to treat an AIDS population of less than two hundred thousand patients. In 1989, further studies indicated that AZT could also be used to treat Human Immune Deficiency (HIV) patients. Many HIV patients do not acquire the AIDS virus. Because the number of patients with HIV was significantly higher than the rare disease population of two hundred thousand, Burroughs was able to exploit the orphan drug status of AZT and market it to the much larger HIV population. The ODA’s exclusivity provision allowed Burroughs to maintain a high price since no competitors were allowed to produce generic drug versions or equivalents of AZT. In bulk, the drug manufacturing cost for AZT was sixty-three cents per dose; it was sold for approximately eight dollars per dose. The treatments required multiple daily doses. As a result, hundreds of thousands of HIV and AIDS patients paid expensive orphan drug prices for AZT. In September 2005 the exclusivity patent expired on AZT, and the FDA subsequently approved four generic versions in the United States.
In November 2005, I spoke with Kelli Shobelock, Director of Public Relations for the generic drug manufacturer Roxane Laboratory. At that time Roxane was approved to sell generic AZT for about $1.80 for a 300mg dose while Walgreens sold Glaxo’s brand name AZT for $6.65 for the same dosage. In Glaxo’s defense, it wasn’t their fault that the sale of AZT as an orphan drug fell into a lucrative “loophole.” However, when sales of AZT exceeded hundreds of millions of dollars, thousands of ill patients could not afford treatment at the inflated cost and morality was abandoned in favor of excessive profits.
It is without debate that the pharmaceutical industry has provided many life-saving and sustaining drugs. It is without debate that a robust drug industry is needed to provide drugs for quality years of life. However, it is also without debate that the demand for drugs, including lifestyle drugs, is growing rapidly and this growth has fueled the need for trial subjects. Subjects the industry does not want to pay much for.
Currently, privately funded research can be conducted behind prison walls in relative obscurity, as such studies are not subject to governmental regulation. Private funds can develop the next “blockbuster” lifestyle drug by testing the safety and efficacy of such medications on prisoners.
The drug industry is one of the world’s most profitable, and it has a strong legislative lobby. This is an industry whose members charged an exorbitant amount of money for the treatment of HIV and AIDS, which, not incidentally, are two diseases overrepresented among prisoners. Should we really believe that drug companies are interested in providing healthcare to prisoners when they also need a valuable commodity that just happens to be available within prisons - a large number of available research subjects? While human subject tests can be carried out in third world countries, which also have expendable populations, this poses a significant logistical inconvenience to the researchers and labs which remain based in the United States.
No Shortage Of Subjects In Prison
In 1999, subsequent to the national and international exposure of the medical experiments at Holmesburg Prison, Brown University held a conference on prison research. The event included speakers from private research firms, pharmaceutical companies and NIH-funded university programs. Many of the protocols presented by the privately funded researchers would have been in violation of federal regulations for prisoner research. However, the OHRP has been and continues to be powerless to enforce the current federal regulations against privately funded researchers.
The International Centre for Prison Studies indicates the United States has the largest incarcerated prison population in the world. Currently, the prison and jail population in the U.S. exceeds 2.3 million. The IOM report recommends expanding the definition of prisoner to include not only the incarcerated as currently allowed, but also those on parole and probation. This would change the definition of “prisoner” and increase the potential pool of medical research subjects. The IOM estimates that the inclusion of parolees and probationers would result in an additional five million subjects in the U.S. protected under the new regulations - and available for research studies.
Dr. Paulsen commented that he chose Washington State Penitentiary for his radiation research because “Prisoners were considered ideal subjects because it would be easy to do follow-up studies. They were a population that wasn’t going anywhere.” The additional five million parolees and probationers that the IOM wants to include as potential research subjects are required to notify state officials if they move, and are monitored by supervising officers on a regular basis. The proposed change in the regulations would create the largest population of controlled and traceable research subjects in the world at a time when there is a severe shortage of biomedical research subjects among the general public. Such a controlled population would create a very large, lucrative testing pool for future medical researchers and drug companies.
For many years the FDA has been under pressure by pharmaceutical companies and consumers to grant faster approval of new drug applications. However, the faster approval processing time must not compromise the safety and efficacy of a drug released to the general population. The IOM-recommended changes in 45 C.F.R. § 46, Subpart C would benefit researchers by allowing more subjects to participate in biomedical trials by expanding the test subject pool through increased access to prisoners. This warrants no guarantee of increased healthcare in prisons and jails; it simply guarantees more trial subjects for researchers. More test subjects may result in shorter trial periods and possibly decrease the risk of litigation caused by a harmful product being brought to market too early due to insufficient testing. These are prized benefits for researchers, but offer increased risks to the trial subjects.
In 1998, Merck used less than 1,000 subjects in an in-house study, titled “090,” to test the efficacy of Vioxx as a pain reliever at low doses. The FDA subsequently approved Vioxx in May 1999 for distribution to the public, approximately six months after an initial New Drug Application was filed. In 2004, Vioxx was removed from the market due to safety issues. During a liability trial in 2006, Merck indicated that it would lose six hundred million dollars of revenue a year if it did not beat its competitors, including Pfizer’s Celebrex, to market.
Merck defended its position to file for approval for Vioxx despite 1.3% of the subjects in the trial study having had a stroke or heart attack versus .02% in the placebo group. Merck noted that the “090” study was too small to be considered a strong result; therefore, the company ignored the risk data of that particular trial.
If Merck had had access to prison facilities and a large number of incarcerated research subjects, it may have been possible to prevent Vioxx from entering the market because of an increased initial trial. On the other hand, they may have decided to bring the drug to market, reap the profits and hope for the best. Of course, we should note that this would be at the expense of a higher mortality rate among the prisoner research subjects. If we arbitrarily project the pool of incarcerated test subjects at 5,000, where the placebo group and active group are in equal quantities of 2,500, we can make the following assumption. If the active group had 2,500 prisoners as test subjects and the adverse event rate was 1.3%, then thirty-three prison subjects may have suffered heart attacks or strokes in a study similar to Merck’s in-house “090” test.
Is the human worth of thirty-three prisoners equivalent to a lower number of non-prisoner subjects? Is research ethics resorting back to the Seattle Artificial Kidney Center dialysis committee of the 1960s, when social worth and status were relevant for resolving the dialysis treatment shortage? If this were the case, then the means would justify the end for economic and gross utilitarian advantage. The beneficiaries of this drug research would be the pharmaceutical companies and those consumers able to afford access to such drugs. Safe drugs on the market is not an impossibility, but at whose expense and at what cost?
No Shortage Of Researchers At Tuskegee
The 2006 IOM report contends that if more researchers have greater access to prisoners, prisoners would have greater access to healthcare. The report further notes that to minimize coercion to participate in the studies, greater access to healthcare within prisons would be needed to conduct justifiable research.
Despite prisoners being the only individuals entitled to healthcare by virtue of their incarceration [see: Estelle v. Gamble, 429 U.S. 97 (1976)], some states have experienced problems providing inmates with even the most basic medical care. In 2005, a federal judge in California ruled in a class action suit, Plata v. Schwarzenegger, that the prison system’s healthcare administration be placed under receivership. In his Finding of Fact and Conclusion of Law, the judge stated, “By all accounts, the California prison medical system is broken beyond repair.
The harm is already done. ... [the situation] could not be more grave and the threat of future injury and death is virtually guaranteed in the absence of drastic measures.” A report issued by the court-appointed receiver in Sept. 2007 found that as many as one in six deaths in California prisons the previous year may have been medically preventable.
In 2001, Mike Ward and Paul Bishop, writers for the Austin American-Statesman, reported in a four-part series on the failure of the healthcare system in Texas prisons. Their series, Sick In Secret: The Hidden World Of Prison Healthcare, was an expose on deficient medical services provided by the Texas Department of Criminal Justice. The University of Texas Medical Branch (UTMB) at Galveston was contracted to insure adequate healthcare for Texas prisoners. During 1998, attorneys hired doctors to review the medical charts of prisoners who had died or were chronically ill from HIV, cancer or diabetes. The American-Statesman reported that the doctors “examined 59 deaths from across the state and found that 20 of the inmates received poor or very poor care. Sixteen of those 20 deaths were either ‘preventable’ or ‘possibly preventable.’” The report described a female prisoner “lying in feces, menstrual fluid and urine” until she died of “severe dehydration.” In another case, a male prisoner deemed in good health, though complaining of heart attack symptoms, went untreated for weeks before his death. These problems existed despite contracted care from one of the premier medical centers in Texas, UTMB at Galveston. Two years later, UTMB was found in violation of prison research protocols.
In 2005, a Nevada judge stated during his sentencing of a female defendant at a parole violation hearing that he was returning her to prison so she could get treatment for her medical, mental health and substance abuse problems. During her incarceration the prisoner went without medications for weeks because prescriptions were not available. The private company that administered medical care took a financial loss, and requested that the state of Nevada take over the program after its contract expired. The medical director for the Nevada Department of Corrections indicated to the state legislature that the company had “struggled from day one” to provide adequate healthcare for prisoners.
As noted in many issues of Prison Legal News, the lack of adequate medical care is a chronic problem in the nation’s lockups. Expanding prisoner research will not solve the larger issues of state and federal budget constraints, poor healthcare management, inept for-profit subcontractors and complacent or incompetent medical administrators.
During the 1930s in Macon County, Alabama, there was no shortage of physicians, researchers and government officials during the infamous Tuskegee syphilis studies. Physicians knowingly failed to treat hundreds of impoverished black men for their “bad blood,” i.e. syphilis. What started as a project funded by the Julius Rosenwald Foundation in the 1920s to provide better healthcare to Macon’s black population ended with nearly forty years of non-treatment for hundreds of sick black men. At Tuskegee, better healthcare came to mean a free autopsy and money for burial. In 1973 the Ad Hoc Advisory Panel on the Tuskegee syphilis study concluded, “Society can no longer afford to leave the balancing of individual rights against scientific progress to the scientific community.”
The duty of researchers is completely different from the duty of physicians to treat patients. The proponents of increased prisoner testing can cite no examples of therapeutic research treatment being denied to prisoners due to the current federal regulations. By contrast, for years almost every issue of Prison Legal News has reported cases of prisoners dying due to a lack of basic medications and elementary healthcare.
I’ll Take Informed Consent For $10 A Day, Alex
The ten-point Nuremberg Code begins by stating, “The voluntary consent of the human subject is absolutely essential.” Ensuring proper informed consent is not a new concept in biomedical research. As early as 1718, King George I offered a free pardon to prisoners in Newgate Prison who agreed to be inoculated with infectious smallpox as part of a medical experiment, which illustrates an early form of coercive non-consent.
Modern research regulations recommend that Institutional Review Boards have “documented” informed consent. A signed document is the most reliable and auditable documentation for the IRB. Though the subject may sign an informed consent form, the researcher should also adequately verify that the subject understands the research process, risks and benefits. Such risks and benefits must not be subjective.
The IOM report is ambiguous on the importance of informed consent. The report states, “These questions about an undue focus on informed consent influences our recommendations. More attention needs to be paid to risk and risk benefit analysis rather than the formalities of an informed consent document,” and “This combined with the myopic emphasis on informed consent is why the current categorical imperative should be abandoned in favor of risk benefit.” However, the report contradictorily notes that “Two elements of research discussed previously “ informed consent and privacy “ are so integral to high-quality ethical research that they require special attention.?
As the IOM recognizes in its 2006 report, prisons have many uneducated and undereducated individuals within their confines. Additionally, the report notes that mental illness, alcoholism or drug addiction is characteristic of approximately eighty percent of prisoners. Darrel Reiger M.D., M.P.H., director of the American Psychiatric Institute, made the following remark to the committee: “Prisons are the largest mental health institutions in our country.” The clarity of informed consent when dealing with this population is difficult at best. When I spoke with Edward Anthony, an ex-prisoner and former research subject at Holmesburg, he admitted that he first learned to read and write while incarcerated.
Mr. Anthony added, “It [being a research subject] was the best paying job at Holmesburg.” In Dr. Heller’s grant proposal for the Oregon prison studies, he requested “$200 per individual subject to be exposed to radiation.” The working wage in Oregon’s prison system at the time was twenty-five cents per day. An article in the July 12, 1963 issue of Time magazine stated that medical research was conducted at 15 of the 37 federal prisons, and prisoners were given “compensation ranging from a pack of cigarettes up to $25 in cash. If a volunteer’s lot is particularly onerous or carries some risk of major discomfort, the Bureau of Prisons may give him ‘meritorious good time credits,’ which shave a few days off his sentence.” The concept of proper compensation is itself an issue that may be impossible to resolve in the prison environment, where even small payments or amenities are significant inducements.
In Mike Ward and Paul Bishop’s four-part series in the Austin American-Statesman, they provided insight into the coercion that prisoners felt to join medical trials. Prisoners, especially those with HIV, joined experimental clinical trials at UTMB Galveston so they could receive treatment outside the prison facility. Ward and Bishop found that the “pill window,” where prisoners picked up their medication, was an area that most prisoners wanted to avoid. The pill window often closed before all medication was dispensed, the lines were long, and many prisoners received the wrong drugs. This made the research visits to UTMB more appealing. It also made prisoners’ participation in the trials coercive through inducement and necessity.
What the non-penal research subject may view as a non-coercive or insignificant compensation scheme may be entirely different within the prison environment. The ideal of non-coercive payment protocols is subjective at best. Current regulations state that incentives should not be “of such a magnitude that [the subject’s] ability to weigh the risks of the research against the value of such advantages in the limited choice of the environment of the prison is impaired.” Of course on the researcher side, the potential economic inducements may be substantial and are not restricted by federal regulations. Capitalism is not the issue and may not necessarily be the problem; the means to achieve the end is a more problematic factor in biomedical research and protocols.
Proper informed consent is not solely comprised of a “signed” document but must be a process. Informed consent must be more than mere words on a piece of paper; the subject must fully understand the experiment and objective risks and benefits, and consent to participate without subtle coercion through compensation schemes. Proper informed consent is already required under the current regulations, and expanding the pool of prisoner test subjects will not improve or result in proper compliance for research protocols in the prison environment.
“We’re From The Government And We’re Here To Help”
The IOM report states that the committee “... determined that the way in which the IRB reviews [how] prisoner studies are conducted need not vary substantially from how these reviews are done currently ....” Despite the committee’s belief that IRBs will not need to change the review process, past prison research at the IRB approval level has failed to comply with the regulations. In addition, IRB members tend to be selected by the institution, company or researcher doing the medical trials. The current regulations require a prisoner advocate member on boards that review prisoner studies; however, researchers have circumvented even that simple requirement.
The University of Texas Medical Branch at Galveston’s Institute for the Medical Humanities has one of the few university programs nationwide dedicated to legal and ethical issues in correctional healthcare research. Regardless, on July 10, 2000 the OHRP sent a letter to UTMB Galveston concerning its research on prisoners. The OHRP cited various violations of 45 C.F.R. § 46, Subpart C during UTMB’s prison research trials; some of the violations were critical enough for the OHRP to ask UTMB to suspend “immediate involvements of prisoners in any federally supported research projects that have not satisfied ... Subpart C.” [See: PLN, April 2001, p.6].
The OHRP found “scant evidence” that UTMB’s Institutional Review Board had made the findings required by federal regulations. The OHRP noted that UTMB was conducting Phase II studies and “perhaps Phase I” studies that did not have a “reasonable probability of improving the health ... of the subject,” and a placebo study was being conducted that had no therapeutic value to the prisoners involved in the research.
A UTMB informed consent form for a Phase II trial stated, “... the subject, or her insurance company will be responsible for the costs of all procedures and medications in the study.” Another Phase II study informed consent form noted “UTMB is not able to absorb the costs of medical treatment in the event the subject is injured.” The OHRP informed UTMB officials that “As it is unlikely that prisoners will have medical insurance after serving their sentences, it is unclear how such an individual would receive follow-up care.”
In 2000, noncompliance letters were also sent to the University of Miami, Yale, Brown University and the University of Florida related to research that used prisoners as test subjects. Noncompliance issues included placebo studies on prisoners, lack of a prisoner representative on the IRB, discrepancies in the subjects’ compensation, inadequate provisions for follow-up care, lack of certifications for the research, and conflicts of interest among serving members of the IRB. The OHRP letters did not threaten the imposition of civil penalties or the removal of prisoner research subjects from the studies. This response validates Jessica Mitford’s observation that prisoners may be cheaper than chimpanzees, or at least the penalties for misusing prisoner test subjects are less onerous.
As Julie Gorey, from the OHRP’s Division of Policy and Assurance, told me, “The impetus to re-examine subpart C arose from this office, and was accordingly voiced by Karena Cooper in 2003 on behalf of OHRP; the desire to examine the subpart did not arise “from” Ms. Cooper, but from the considered opinion of OHRP after years of experience with the subpart.”
However, OHRP failed to provide a specific answer as to what event(s) may have prompted them to reconsider the federal regulations.
Some researchers and prisoner advocates speculate that the review of the current regulations by OHRP resulted from the problems uncovered at UTMB.
One research official at UTMB noted via e-mail that “UTMB was visited in September 2000 initially to review our processes for including prisoners in research. As you know, UTMB’s MPA was restricted and we were required to re-review protocols and respond with an extensive action plan. We did so and the restrictions were lifted completely. From that point forward, OHRP made staffing and procedural changes to become more responsive to requests for review of research involving prisoners. I believe that OHRP did not really have a process for reviewing or certifying research involving prisoners even though they required adherence for all institutions and the regulations stated that they would have a process. I also believe that they actually wrote their procedure for handling reviews and certifications based on their experience with UTMB.”
Many of the noncompliance issues cited above were not administrative oversights or misinterpretations of a particular piece of language, but clear violations of the ethical spirit of the law by researchers and institutions. Such laws and rules are clearly stated in the current regulations related to research on prisoners. IRB members are charged with preventing the exploitation of research subjects. Many of the IRB members are of greater intelligence than the subjects they are to protect. Therefore, many of these violations are inexcusable and willful.
Some IRBs over prison research have failed miserably and may continue to fail miserably unless conflicts of interest are eliminated.
Conflict Of Interest? What Conflict Of Interest?
The IOM report fails to address the complexity of conflicts of interest arising from prison research. Additionally, the report does not emphasize the objectivity of the researcher or IRB despite apparent conflicts of interest that may take place in a closed and opaque prison environment.
At Holmesburg, Dr. Kligman benefited financially through his company, Ivy Research, and the discovery of Retin-A. In 1990 the University of Pennsylvania sued Kligman and Johnson & Johnson, claiming that Kligman’s discovery of the drug intentionally interfered with his contractual obligations as a university researcher. An out-of-court settlement, with an undisclosed dollar amount, allowed the university to receive future royalties from a derivative product of Retin-A. Clearly, Dr. Kligman’s financial arrangements created a situation that was best for Ivy Research and not the Holmesburg prisoners. Similarly, Drs. Stough and Wisdom benefited financially from their lucrative contracts with drug companies to use Oklahoma prisoners as test subjects.
In 2002, in a study published in the Journal of the American Medical Association, researchers from the University of Toronto surveyed 192 medical experts who participated in writing 44 sets of guidelines for the treatment of various illnesses. Of the 100 survey respondents, nine out of ten confirmed they had some type of relationship with a drug manufacturer. Six out of ten respondents authored guidelines involving a treatment from a company with which they had a financial relationship. Of the 44 drug guidelines written, only one included a conflict of interest that was acknowledged in the authored report.
In 2006, a survey published in the New England Journal of Medicine, titled Financial Relationships between Institutional Review Board Members and Industry, indicated that 36.2% of the IRB respondents had at least one financial relationship with the drug industry within a year prior to the survey. Of the IRB respondents, 22.1% disclosed they had received research money from the industry in the previous year. Seventy-eight percent of the IRB respondents indicated that a protocol had come up in the prior year that involved a company or competitor of a company with which they had a financial relationship. The most disturbing statistic in the survey was that approximately 35% of the IRB members rarely or never disclosed their conflict of interest to the board.
Regulations governing conflicts of interest for federally funded research are set forth in 42 C.F.R. 50, Subpart F and 45 C.F.R. 94. A conflict of interest is defined as a significant financial interest in the research. Specifically, “Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).”
Because “significant” is a subjective term, the regulations contain some de minimus rules. For example, they state a conflict does not exist if “An equity interest that when aggregated for the Investigator and the Investigator’s spouse and dependent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity.” The problem with these regulations is that the research institution, for which the researchers work, is the watchdog responsible for mitigating or avoiding conflicts of interest.
In 1999, a novel gene therapy was attempted on eighteen-year-old Jesse Gelsinger at the University of Pennsylvania Medical Center. Jesse suffered from a rare disorder called ornithine transcarbamylase (OTC) deficiency; the disorder is usually fatal for newborns or children through the age of five. Though Jesse’s daily regimen of medication and special diet were arduous, he enjoyed a relatively normal life. Many ethicists wonder why the university and researchers allowed Jesse to partake in the gene therapy. Despite some health setbacks, it appeared that he could maintain his usual regimen and continue living in relative health.
Jesse started the unique and experimental gene treatment on September 13, 1999. During the course of treatment he became severely ill, and he was declared brain dead on September 17, 1999. What makes this case problematic is the irresponsibility of the university, IRB and researchers who failed to disclose and mitigate their financial conflicts of interest concerning Jesse’s treatment. In the Gelsinger family’s pursuit of litigation, it was discovered that the University of Pennsylvania and the researcher, Dr. James Wilson, had equity and income interest in the company that was producing the gene therapy.
The company, Genova, was founded in 1992 and Dr. Wilson was a major shareholder. The university held an equity interest in Genova; additionally, millions of dollars were directed from Genova to the school’s human gene therapy institute in the years prior to Jesse’s death. Dr. Wilson was the director of the gene therapy institute at the University of Pennsylvania. Prior to legal discovery this incestuous relationship was not disclosed by the university or the researcher, which impaired the IRB’s judgment when approving the use of the gene therapy on Jesse.
If this decision was impaired for an eighteen-year-old non-incarcerated educated white male at a leading medical center, how can we expect conflict of interest problems not to exist in prison research? The regulations failed for Jesse because the University of Pennsylvania had not adequately monitored the existing conflicts of interest - conflicts in which they had a financial interest of their own.
Earlier in this decade, a great deal of legislation was enacted to protect investors, employees and other financially-related parties from the conflicts of corporate executives. Conflicts of interest have no place on Wall Street, in the boardroom, and particularly in human biomedical research. Therefore, expansion of any research among the prison population should include recommendations for the comprehensive review of and remedies for researchers’ conflicts of interest. The remedies must create a financial risk that is far greater than the potential reward from nondisclosure of such conflicts.
Justice For All?
Despite 11.4% of the adult U.S. population being classified as black in the 2000 census, 46.2% of all prisoners incarcerated in state and federal prisons were black according to 2000 data. In the general population of the U.S. among non-elderly blacks, 20.9% are classified as uninsured for healthcare versus 13.2% for non-elderly whites of non-Hispanic race. In addition, 25.2% of non-elderly blacks use Medicaid as their primary insurance coverage compared to 9.3% of non-elderly, non-Hispanic whites.
Based upon these statistics, prisoner trial subjects, who are disproportionately black, will have a lower likelihood of being beneficiaries of the outcomes obtained from their participation in clinical research. This results in an unequal distribution of the benefits of research, particularly for black incarcerated trial subjects.
Due to the social and economic disadvantages of harmed prisoner test subjects, corrective legal action may be difficult to obtain in prison research cases. In October 2000, a group of 300 plaintiffs, including Edward Anthony, filed suit against the City of Philadelphia, Dr. Kligman, Johnson & Johnson and Dow Chemical related to the research conducted at Holmesburg Prison. U.S. District Court Judge Herbert J. Hutton dismissed the case based upon the expiration of the statute of limitations. The defendants presented various articles on the deleterious effects of the prison tests that had been published prior to the Holmesburg lawsuit, which was filed 24 years after the experiments ended. The judge reasoned that prior “salient facts” should have “awakened inquiry on part of the plaintiffs [former inmates],” and put them on notice to file the lawsuit sooner.
The sources cited by the judge for such “salient facts” included The New York Times, The Washington Post and the Atlantic Monthly. Of course, impoverished and imprisoned semi-literate or illiterate plaintiffs generally do not read those publications. In 2007, the Atlantic noted on its audience profile that 78.1% of its readers have a college degree and a median household income of $138,076.
Not all cases brought by prisoners against unethical researchers have been dismissed. In 1976, twenty prisoners involved in Dr. Heller’s testicular irradiation experiments sued Heller and the State of Oregon.
According to the Department of Energy’s Advisory Committee on Human Radiation Experiments Report, the lawsuit settled out of court in 1979.
Nine plaintiffs each received $2,215 in damages - a paltry sum for having their testicles bombarded with as much as 600 rad (a unit of measurement for radiation), the equivalent of approximately 3,000 typical diagnostic chest X-rays at once. A subsequent lawsuit filed by prisoners who took part in the Heller studies resulted in an April 2001 settlement for $1.5 million, or an estimated $30,000 per plaintiff after attorney fees, costs and expenses. [See: PLN, Dec. 2001, p.19].
Washington state prisoners who participated in Dr. Paulsen’s radiation experiments fared better, obtaining a $2.4 million settlement in a class action suit in March 2000. Still, this amounted to only $100,000 to $150,000 per surviving prisoner, less attorney fees, costs and contingency fees, for thirty years of medical neglect and compromised health. [See: PLN, Nov. 2000, p.24].
Unfortunately, like the blue code of silence among law enforcement, there seems to be no incentive for officials at a violating institution to “self police” researchers who cause harm or use unethical protocols in their research. There appears to be no long-term consequences for the institution that allows its researchers to conduct unethical trials, or that fails to hold its IRB accountable for approving unethical research protocols. Thus, there is little or no administrative recourse for prisoner test subjects who are victims of unethical research studies.
Typically the prisoners who participate in such experiments must sign waivers of liability promising not to sue the experimenters if they are killed, crippled or injured in the course of the experiments.
Further, an ancillary cost that is often neglected is the cost paid by taxpayers or insurance companies for the care of medical research subjects later in life. Despite researchers and drug companies profiting handsomely from such research, society is left to pay for the long-term health consequences. During UTMB’s studies they specified that the subject or the subject’s insurance company would be responsible for aftercare. With healthcare costs spiraling for the average American, the public should be outraged at this attitude. In recent years the tobacco industry was made to reimburse government health plans for the ill effects of smoking. Should medical researchers and pharmaceutical companies receive a “get out of jail free” card on this issue? Who will pay for the latent illnesses, most likely cancer, that result from Heller and Paulsen’s radiation studies?
What Does The OHRP Do, And What Should It Do?
Proponents of the IOM report believe that prisoner advocates do not want prison research. Advocates say they want responsible and ethical prison research that will benefit the prisoners’ health and well-being and not provide financial windfalls to researchers at the expense of the inmate test subjects. They argue that this basic request for ethical research is no different from many of the therapeutic trials done on patients afflicted with various illnesses in the general populous, including women and children.
The current regulations tied to federal funding, and the lack of enforceable action that the OHRP can take against private researchers, create a common interest among federally funded university researchers and prisoner advocates to oppose the expansion of prison research. If no one is carefully overseeing privately funded prison research by big pharmaceutical companies and private contract firms, then why expand such studies?
A database of prison research, as recommended by the IOM, should be a high priority for the OHRP. Currently, privately funded researchers can conduct prison medical experiments without much oversight. Both government-funded and privately funded research should be tracked, and all biomedical trials should adhere to the same ethical standards. Rather than holding only publicly funded researchers accountable, the regulations need to hold all researchers accountable. Allen Hornblum, author of Acres of Skin and Sentenced to Science, shared with me an interesting question: “Who is going to watch the integration of the privately funded researcher in the privately owned prison?”
Some attendees at the 1999 Brown University conference, including researchers and opponents of the IOM report, said the OHRP appeared “clueless” on the enforcement of prison research regulations. As one prison researcher informed me, “... complying with the current regulations was not difficult.” That researcher also indicated that the lack of enforcement and a different playing fields for privately funded researchers put universities at a commercial disadvantage to earn royalties on drug discoveries. So did the IOM recommend changing the existing federal regulations with this commercial disadvantage to universities and institutions in mind? If so, that is certainly something they would not admit.
It may be time for NIH-funded institutional researchers and opponents of prison research to cease being suspicious of each other and demand greater accountability for the privately funded researchers that presently avoid OHRP oversight. Also, the OHRP needs to be held responsible for fully understanding the regulations that are in place and enforcing those regulations; it should no longer be a “paper tiger” agency.
If all parties claim to be altruistic and have the prisoners’ best interests in mind, then a common ground should be reached to provide necessary healthcare in prison. All secret or unmonitored medical research in prisons should be eliminated. Privately funded researchers must be held responsible in terms of conducting ethical research trials in the subjects’ best interest, and all researchers should demand that the OHRP fully understand its responsibilities.
It would be absurd to suggest that an agency such as the Internal Revenue Service could not conduct audits because it did not understand its own tax laws. Yet this is exactly what the OHRP has demonstrated. Changing or expanding the types of research allowed in prisons will not alter the OHRP’s responsibility to provide proper oversight and enforcement of the regulations. The focus should be on who is conducting research on prisoners and what they are doing in the research trials.
As advocates of the IOM report suggest, no amount of research will fix the healthcare status in prisons or prevent immorality among researchers, and the current federal regulations are not that difficult to understand.
They only become difficult when you compile two hundred pages of recommendations to explain four pages of existing regulations, as in the IOM report. If the protections of Subpart C of the regulations can easily be changed, how long will it be before Subpart D, Children Involved as Subjects in Research, is scrutinized and likewise found to be too restrictive for researchers?
Greg Dober is a freelance writer in healthcare ethics. He obtained his Master of Arts in Bioethics and Health Policy from Loyola University of Chicago in Illinois. Currently, he is enrolled in the Doctorate of Health Care Ethics, DHCE, program at Duquesne University’s Center for Healthcare Ethics in Pittsburgh. He is a member of the American Society of Bioethics and Humanity (ASBH) and the American Academy for the Advancement of Science (AAAS). He reviewed Allen Hornblum’s book, “Sentenced to Science,” in the Dec. 2007 issue of PLN, and authored this article as a PLN exclusive.
A Timeline of Key Events in Prison Medical Research
1947 : Nuremburg Code established.
1950s through 1970s : Dr. Kligman conducts experiments on inmates at Holmesburg prison.
1960s through 1970s : Drs. Heller and Paulsen conduct radiation experiments on prisoners in Washington and Oregon.
1964 : Declaration of Helsinki signed by U.S.
1966 : Animal Welfare Act established.
1973 : Mitford publishes Kind and Usual Punishment.
1974 : President Nixon signs the National Research Act.
1978 : 45 C.F.R. 46, Subpart C established for research conducted on prisoners.
1979 : Belmont Report on ethical guidelines for prison research issued.
1980 : FDA adopts 21 C.F.R. 50.44, which bars prisoners from Phase 1 clinical trials.
1998 : Allen Hornblum publishes Acres of Skin.
1999 : Brown University prison research conference is held
2000 : OHRP sends noncompliance letters to UTMB and other universities for improper prison research.
2003 : ILAR notes a shortage of research monkeys.
2003 : OHRP requests formation of a committee to examine changing prison research regulations.
2005 : IOM committee formed
2006 : IOM committee issues report to change 45 C.F.R 46, Subpart C.
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