Statement before the Committee on Ethical Consideration for Revisions to DHHS Regulations on Protection of Prisoners Involved in Research

Presented by Vera Hassner Sharav
July 18, 2005

142 West End Ave. Suite 28P
New York, NY 10023
Contact: Tel. 212-595-8974

The Alliance for Human Research Protection (AHRP)
www.ahrp.org

On behalf of the Alliance for Human Research Protection, or AHRP, I want to thank the members of the Committee, for this opportunity to share with you our understanding of the complex problems presented by medical research involving vulnerable populations, such as prisoners and children. We appreciate your difficult job, and recognize that you will need to exercise courage in your assigned mission, which is to protect prisoners from research abuse and exploitation. "Courage," in this context, means the courage to acknowledge uncomfortable facts about current practice and to speak truth to power, which is always a risky business.

AHRP’s mission is to advance responsible and ethical research practices by advocating openness, full disclosure, and accountability. To achieve that goal, we disseminate educational materials to legislators, regulators, academics, and the public.

Our primary concern is the threat to safety posed by the ubiquitous influence of big money from pharmaceutical companies. Their business imperative is to increase profits by rapidly developing and bringing to market new drugs and new uses for patented drugs. Unfortunately, corporate priorities often collide with patient safety, raising serious ethical concerns. Business ethics have had a corrosive effect on the conduct of clinical trials and the integrity of academic medicine and the scientific literature. Public trust in medicine has been badly shaken by disclosure of deceptive practices and concealed drug hazards. Regulation is all that stands in the way of a return to anarchy in the medical marketplace, where snake oil salesmen have a free-for-all, the public-be-damned. If the irresponsible marketing of Vioxx, Propulsid, Baycol, FenPhen, and many of the psychotropic drugs, are any indication, we are increasingly at risk of returning to a time when medicine killed more patients than it cured. We recognize that the members of this committee will come under pressure, we ask you to stand firm with the public for whom safety is the primary concern.

Prisoners were, not long ago, the most preferred of all medical research animals. The historic record of US prison research abuse is uncontested.[1] Allen Hornblum documented the appalling conditions of prison research in Acres of Skin.[2] "American doctors regularly injected and infected inmates with malaria, typhoid fever, herpes, cancer cells, tuberculosis, ringworm, hepatitis, syphilis and cholera." [3] In 1976, the President of the Pharmaceutical Manufacturers Association, Joseph Stertler,[4] estimated that 85 percent of all phase 1 testing – trials posing highest risk – was done on prisoners. Jessica Mitford,[5] in her revealing article in The Atlantic Monthly, quoted a doctor who inadvertently revealed prisoners’ financial attraction: "Criminals in our penitentiaries are fine experimental material – and much cheaper than chimpanzees." Prisoners are not only cheaper than chimpanzees – their only armor against being subjected to experimental abuse hangs on the thread of a single federal regulation that governs only federally funded research. Under 45 CFR 46, Subpart C (section 306) prisoners can only be included in government sponsored research "which has the intent and reasonable probability of improving the health and well-being of the subject." Thus, randomized, placebo-controlled drug trials are not permissible in research involving prisoners.

Chimpanzees, by contrast, are protected by mandatory rules, oversight and enforcement mechanisms under the 1966 Animal Welfare Act. No federal law requires anyone to keep track of the number of humans used in clinical trials – estimates are between 10 and 20 million. Nor does anyone track the number or nature of clinical trials – there is talk about a registry. No one is held accountable for unnecessary duplication of harmful experiments. There are no penalties for failing to report adverse events, or for failing to provide follow-up care for research subjects who may have suffered adverse effects. Laboratory animals, by contrast are protected by mandatory unannounced inspections, requirements for humane care and treatment, and the Department of Agriculture must submit annual reports to Congress documenting the number and disposition of every chimp, dog, rabbit and hamster used in research trials.

What sets human subjects apart from animals is the universal prohibition enshrined in the Nuremberg Code and affirmed in the ethics codes that followed: the voluntary, comprehending, informed, consent of the human subject "is absolutely essential" before any medical research may be conducted. Voluntary, informed consent is by definition impossible to obtain in a prison setting. The reason prisons are shrouded in a veil of secrecy is they hide a world of institutionalized brutality and abuse – both physical and psychological. No one outside of prison walls knows what happens in a prison. Visiting outsiders – such as public officials, Congressional subcommittees, or advisory committees – have no inkling about the level of fear, intimidation that prisoners are subjected to. Prisons are not rehabilitation centers; they are places that breed hardened criminals. The rate of recidivism is 67.5% within three years.[6] The second offense is typically more severe than the first.

Current research regulations were adopted in 1978 after a deluge of public disclosures about abuse of prisoners. The nature of abuse that prisoners are subjected to within the context of prison medical care has been laid bare before a federal judge in California. In weeks of testimony, medical experts described "horrifying" and "barbaric medical conditions… resulting in as many as 64 preventable deaths of inmates a year and injury to countless others." A report to the court concluded that health care facilities at San Quentin "pose a risk of imminent harm and death to patients….Conditions are deplorable and have no semblance to a medical setting whatsoever." On July 1, 2005, Judge Thelton Henderson took the extraordinary measure of removing the entire $1.1 billion prison health care system from the state’s jurisdiction, calling it "an outright depravity." He said "action must be taken to at least begin to limit the harm to inmates." The abuse "violates inmates’ constitutional right against cruel and unusual punishment."

California also has the dubious distinction of locking up the largest number of juveniles in the nation. Between 4,000 and 10,000 youthful offenders (called wards), have been incarcerated at any given time[7] in camps and institutions operated by the California Youth Authority (CYA) – at an annual cost of $80,000 per ward.16,[8] About 50% have a mental or emotional problem–44% of males and 61% of females – and 38% of males and 50% of females have both mental and substance problems.[9] The juvenile justice system was not intended to be punitive, and CYA’s stated mission16 is exemplary: "We treat all people with dignity, respect and consideration." Also, "We demonstrate behavior which is fair, honest, and ethical." State law requires CYA to provide youthful offenders an "education, training, and treatment services." But the reality bears no resemblance to any of its written commitment. Wards housed at CYA facilities are subjected to inhumane, institutionalized brutality beyond belief. Many were locked in cells for 23 hours per day, sprayed with mace, heavily drugged with psychotropic chemical restraints, and during their one hour of classroom "instruction" they were locked into steel mesh cages like pit bull dogs. The cages are euphemistically called, SPAS (acronym for Special Program Areas). One juvenile admitted: "I was living in fear 22 hours a day in that place." Another stated: "It was too dangerous to sleep at night." Fifteen youths have committed suicide since 1996.16

Juveniles who are detained in deplorable conditions are certain to fill the adult prisons. Nationally, the recidivist rate for juveniles is between 56%–91%. Inmates released from CYA return or "graduate" to adult prisons within 3 years. Recently, a publicly aired video tape provided a glimpse into institutionalized depravity. A guard was taped setting his German Shepard to attack a juvenile at Stockton.[10] At this same facility, in 1997, a Stanford psychiatrist conducted an experiment on 61 inmates aged 14-18, to test the effectiveness of the anti-epileptic drug, Depakote, for use as a chemical intervention to reduce aggression. [Attached] Federal regulations restrict the use for minors who are wards of the state to research "conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards." [11] Wards at CYA facilities are captive prisoners. As such, they are entitled to state and federal[12] restrictions. California law explicitly states: "no medical research shall be conducted on any prisoner in this state."[13] The Stanford IRB approved it, and its lawyers defended it. Beyond the legitimacy of its approval, there are many questions about informed consent, disclosure of risks associated with Depakote.

It is inconceivable that an Institutional Animal Care and Use Committee (IACUC) would ever approve research to be done on animals housed under prison conditions. IACUC panels who inspect animal facilities can better appreciate that inhumane living conditions are not suitable for research. A prison doctor told the Chronicle Prisons "were not designed to be the Mayo Clinic. They are essentially dungeons."[14] Many IRB members are academics. They are probably the least knowledgeable about the hazardous, brutal, and unsanitary conditions under which research on prisoners is conducted. Some IRB members have even objected to have a single prisoner in the room when prison research was discussed.[15] Is it any wonder that society’s outcasts have been subjected to research projects that are unethical by any standard?

The inhumane circumstances leading to California’s prison health care receivership[16] and other equally abhorrent examples of abuse are especially relevant for the committee’s deliberations. AHRP is submitting to the committee a compilation of documents providing the necessary information on which the IOM committee can rely as it "examines whether the conclusions reached by the National Commission in 1976 remain appropriate today." Evidence of continuing abuse and inhumane prison conditions argues the need to maintain and enforce very stringent restrictions on conducting medical research on prisoners – if such research is permitted at all. There are two distinct choices: Either (1) prohibit all medical experiments on prisoners – as is the law in California – or (2) establish court-appointed independent oversight. As a captive population, prisoners will always feel constrained to agree to participation in research.

Clinical trials are pivotal for the drug industry – the trials require large number of human subjects to provide the data essential for FDA approval. The litmus test for permissible human research is that subjects are fully informed volunteers. But volunteers are increasingly in short supply in the free world, while the financial incentives to test drugs and vaccines are immense. Pharmaceutical company sponsors, physicians, and medical centers alike are stakeholders in clinical trials. The shortage of research volunteers presents a moral challenge – do we, as a society deprive the most vulnerable among us, of the fundamental human right to refuse to be subjected to medical experiments? Stakeholders have adopted a two-pronged strategy to get around informed consent requirements: Increasingly, drug trials are outsourced to underdeveloped countries,[17] and pressure is being brought to bear to loosen federal restrictions on the use of prisoners and children in medical experiments.

I am here to inform you that there is a "cut-throat competition for research subjects," and evidence of a thriving, albeit, immoral, Human Subjects Trade.[18] The traffic in human subjects is driven by pharmaceutical companies who offer hefty finder’s fees. An illuminating article in the Journal of Law, Medicine & Ethics (2003), by Trudo Lemmens and Paul Miller of the University of Toronto, document the corrupting impact that finder’s fees have on integrity of the process and the validity of the findings. First among those on the take,[19] are physicians both in academia and the community, some of who are using "outrageously bad clinical judgment just to get subjects into a trial." [20] Some doctors enroll patients who do not even have the disease being studied. Lemmens reports that employees at university hospitals and clinics are also getting finder’s fees ranging between $2,000 and $5,000 per subject referred to a clinical trial. A research coordinator was reported to have tried to "persuade" another coordinator "to transfer a research subject to her industry-sponsored trial with the promise of a lucrative finder’s fee."7 There are reports of nursing home staff harassing patients to enter clinical trials, threatening to send them home if they don’t agree.9 Does anyone seriously have any doubt how such trading in human subjects is guaranteed to flourish in prisons?

The current oversight system governing human research relies on institutional review boards (IRBs) whose embedded conflict of interest precludes any semblance of independence. Clinical trials are a very lucrative staple at medical schools that obtain a government license (the MPA or FWA) to conduct human experiments that are funded by the government. Depending on their negotiated contract with the Office of Human Research Protections (OHRP), they may or may not agree to follow federal regulations in all human research.

How often are ethical corners cut under pressure to speed up the approval process? How often are patients enrolled without their knowledge or consent?

How often are all reasonably foreseeable risks, possible benefits, and alternatives fully disclosed to subjects before consent is obtained?

The serious deficiencies[21] of the IRB system are documented in numerous federal investigations: The FDA found that less than 20% of academic IRBs complied with federal requirements.[22] Some IRBs spend two minutes reviewing complex protocols.[23] Even the small sample of letters of determination posted on the OHRP website reveals that IRBs at major universities undermine the spirit and letter of informed consent requirements, and fail to ensure that the most serious known and /or foreseeable risks are disclosed to subjects. The Johns Hopkins IRB was severely criticized by the Maryland Court of Appeals for helping investigators skirt regulatory compliance.[24]

A body of evidence and unending stream of documented reports (primarily uncovered by investigative reporters), shows that research abuses generally and in particular when vulnerable populations are the subjects, have only been reduced since the regulations were adopted, abuses was by no means eliminated. The OHRP letters show that IRBs at powerful institutions are often repeat offenders. Although those who have a stake deny it, medical research is a very risky endeavor for any human subject – how much more so for prisoners and children.

Those who want to loosen restrictions on the use of prisoners and children in medical and behavioral high risk experiments argue that it would be detrimental to these vulnerable populations to "deprive" them of the benefits of experimental treatments that would be – or might be – beneficial to their health. When examined closely, this rationale always, or almost always, fails. The number of patients enrolled in a study of an investigational treatment is always a tiny fraction of the potential patients who may derive a benefit – IF – big if – the drug is shown to be safe. But what if the drug turns out to be lethal? Given prisoners’ fewer avenues of redress, it is not hard to see who has the most to gain from using prisoners. Investigations are continuing into a series of phase I AIDS drug and vaccine trials conducted on infants and children who were wards of the state, in foster care – some of the infants were merely "presumed" to be HIV-infected.[25]

A four part investigative series, "Sick in Secret: The Hidden World of Prison Health Care," by Mike Ward and Bill Bishop in the Texas Statesman (December 2001-2003) uncovered a covert, interlocking system of abuse in the Texas prison health care system operated by the University of Texas Medical Branch (UTMB) since 1993. UTMB is charged with providing care to 80% of the 146,000 inmates in the prison system, Texas Tech is responsible for the remainder. UTMB continues experimenting on prisoners, apparently ignoring the federal prohibition on the use of prisoners in medical experiments unless they "have the intent and reasonable probability of improving the health or well-being of the subject." Absolute, impenetrable secrecy surrounds the Texas prison health-care system. Texas law (1999) precludes anyone from monitoring the quality of care provided by the universities. This insular, publicly financed health care system has become a $297-million-a-year business that is immune from any public scrutiny. UTMB is accountable to no one, it is essentially free to cover its tracks and bury its failures as well as its dead bodies with complete impunity.

The Texas Statesman series provided documented evidence of how UTMB operated a two track health care system of vastly unequal quality. UTMB’s two track system of care ensure that prisoners will seek better care at the University’s Galveston branch to avoid being maltreated in sub-standard prison clinics, where their lives are put at risk. But to gain access to UT hospital care there was a hitch: prisoners had to become human subjects in experimental drug trials. Advertisements at UTMB’s public hospital in Galveston promised free treatment to those who enroll in research trials. UTMB has run thousands of clinical research trials and its Office of Clinical Trials boasts that one of the "special features" available at UTMB is the prison hospital, and the tens of thousands of Texas inmates who look to that hospital for medical care. Texas Tech University does fewer. The Statesman reported that until late 2000, "UTMB conducted dozens and possibly hundreds of trials without telling state prison officials what it was doing – violating a longstanding prison system rule."

In 1998, doctors retained by plaintiff lawyers reviewed the medical charts of inmates who had died and others who suffered from chronic conditions such as HIV, diabetes and cancer. The doctors found that that 20 of the 59 inmates whose charts they examined who died received "poor" or "very poor" care. And 16 of those 20 deaths were either "preventable" or "possibly preventable." As recently as March, 2001, a prison review found that half of the prisoners discharged from prison clinics and hospitals had incomplete documentation, and one in every 10 required "emergency, acute care or readmission following discharge."

An investigation of UTMB in January 2000 by OHRP[26] found that in 220 protocols prisoners were included – among these 95 were federally supported projects. In a letter of determination, OHRP ordered UTMB to "Suspend immediately involvement of prisoners in any Federally supported research subjects that have not satisfied all requirements of HHS regulations." It is clear from OHRP’s letter of findings that UTMB violated federal research regulations pertaining both to restrictions on the inclusion of prisoners, and those involving protections for children, as well as basic human research protections. The UT IRB summarily approved inclusion of prisoners in research involving greater than minimal risk not intended and with no evidence to demonstrate "reasonable probability of improving the health and well-being of the individual subject." The IRB failed to meet its legal responsibility by failing to review research it approved, and failing to ensure and document that informed consent had been obtained. Some consent documents included exculpatory language which stripped prisoners of their legal rights, and UTMB attempted to renounce its regulatory responsibility to provide follow-up care necessitated by participation in research. A follow-up letter,[27] September 14, 2000, expanded in greater detail on the IRB’s failings.

Prison conditions pose hazards to health and undermine the integrity of research:

In an effort to cut costs, UTMB changed medication dispensing policy at Texas prisons, making it more difficult for ill prisoners to adhere to their prescribed medication regimen.

Prisoners are not allowed to keep their prescribed drugs, and must receive their medications at a pill dispensing window which is open for only a short period. Inmates often miss receiving their prescribed medication, or receive the wrong drugs. They complain that the pill window problem makes it impossible to maintain the strict schedule required to treat HIV. Prisoners’ complaints were corroborated by a UTMB doctor whose own study revealed that Texas prisoners frequently develop a drug-resistant form of HIV. He acknowledged that the "unique obstacles" in prison contributed to this phenomenon, "including the fact that prisoners must ask for each dose from a pill-dispensing window."

Prisoners have also complained that drugs they are prescribed through research studies at the UTMB hospital in Galveston are sometimes confiscated and thrown away when they return to their units. Their complaints have been corroborated. A former prison nurse who was fired after challenging the practice, said: "I saw garbage cans full of study drugs." Dr. Steven Jenison, who headed the infectious disease bureau in the New Mexico Department of Health, reviewed prison health-care procedures and hundreds of medical charts on behalf of prisoners in a 1999 federal court case. He testified 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." He was told by prison clinic staff that "inmates returning from the UTMB clinic often have their clinical trials medications confiscated by corrections officers and ‘flushed down the toilet.’ "

Researchers and sponsors covet prison populations for reasons of opportunism and convenience. Access to a large pool of captive human beings facilitates rapid enrollment in clinical trials. As captives they can’t drop out – thereby eliminating a major problem for clinical trialists. Prisoners don’t move without leaving an address – their whereabouts are monitored 24 hours a day, and their diet and waking regimens are controlled. Beyond convenience, prisoners are devalued, disenfranchised human beings for whom society has no sympathy. Their deprivations and status as an underclass are particularly valued by academic and industry researchers who use the opportunity to dispense with whatever formal procedures are followed at civilian research centers. Prisons, which are a world onto itself, are an easy place to burry the bodies with impunity.

But, as we’ve discovered, prisons present extraneous variables that can ruin both the data and the subjects’ health, as, for example, arbitrary closing of the "pill window." Additionally, the culture of lawless in prison sabotages the basics of controlled clinical trials. A prison milieu is incompatible scrupulous compliance with protocol requirements – without which there is no scientific integrity. Thus, one has reason to be suspicious about the integrity of prison research – it may, upon independent examination prove to be fraudulent, junk science.

Prisoners have never lost their attraction for researchers – despite the appalling prison conditions which clearly preclude scientifically legitimate research. In 1999 the Los Angeles Times reported: "Researchers covet prison populations for studies, experts say, because they provide a constant, controllable group. The inmates all eat the same food, sleep the same number of hours and are easily accessible."

To deprive vulnerable children or prisoners of their hard won federal protections on the basis of unproven, presumed benefits of participating in experimental trials would be the height of cynicism. Stakeholders are invoking the scourge of HIV-AIDS to make the case that clinical trials are the only way for prisoners to gain access to effective drugs. They hope that by wagging the HIV-AIDS tail, they will shift the focus of discussion from the fundamental moral principle that defines a civilized society. Prisoners with AIDS deserve decent treatment – NOT a quid pro quo to coerce them into becoming guinea pigs. Efforts to lift the sanctions against medical experiments on prisoners is NOT emanating from prisoners.

AHRP RECOMMENDATION:

Clearly, oversight by IRBs and barely by the executive branches of government – federal state, or local – has demonstrably failed to protect both the safety of human research subjects, and the integrity of science. AHRP offers the following recommendation to fill the gap in the current system. What is missing in the current research oversight system is a mechanism to ensure independent checks and balances. Our recommendation follows from the model proposed in 1973 by the Department of Health Education and Welfare,[28] but never adopted. We recommend that for each medical trial in which vulnerable populations such as prisoners and / or children are sought as research subjects, a court-appointed, independent Research Protection Committee (RPC) should be provided to serve as advocates for such subjects throughout the process. The RPC would have authority to decide whether the trial was in the individual subject’s best interest, monitoring the selection of subjects, assessing their uncoerced willingness to participate – in the case of children, assessing the reasonableness of parental permission to ensure no extraneous enticements have been offered. The RPC would assess the adequacy of disclosure in informed consent documents, and monitor the well-being of the subject and his / her continued willingness to participate.

The Research Protection Committee, if it is to work, must be independent of executive branch finagling. Thus, it must be court-appointed and supervised! The record fully supports this position. Furthermore, the scope of the court-appointed and supervised RPC should cover ALL research, whether funded by government or private sources. Last, the 1976 National Commission’s recommendations for research involving prisoners seem appropriate – but, again, lack a mechanism for effective enforcement.

References

[1] Final Report of the Advisory Commission on Human Radiation Experiments (ACHRE). 1995. Online at: http://www.eh.doe.gov/ohre/roadmap/achre/ See also: https://ahrp.org/ethical/EthicalViolations.php References and attachments:

[2] Allen M. Hornblum Acres of Skin: Human Experiments at Holmesburg Prison. Routledge, 1998.

[3] Silja J. A. Talvi, The prison as laboratory, In These Times, January 10, 2002. [Attached]

[4] Stetler statement to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is reported in the Commission’s Report and Recommendations; Research Involving Prisoners (1976), p. 47; and Silja Talvi wrote: "by 1972, the pharmaceutical industry was doing more than 90 percent of its experimental testing [of humans] on prisoners." See: Talvi

[5] Jessica Mitford, "Experiments Behind Bars: Doctors, Drug Companies, and Prisoners," Atlantic Monthly 23, January 1973, 64-73. Jessica Mitford, Kind and Usual Punishment: The Prison Business (New York: Alfred A. Knopf, 1973), 138-168.

[6] Patrick Langan and David Levin. Recidivism of prisoners released in 1994, Bureau of Justice Statistics, June 2002. At: http://www.ojp.usdoj.gov/bjs/pub/pdf/rpr94.pdf

[7] Randall G. Shelden, The Failure of Youth Prisons–A Notorious Example: The California Youth Authority. Excerpt a portion of chapter 12 from my forthcoming textbook Delinquency and Juvenile Justice. [Attached] http://www.sheldensays.com/Res-eight.htm

[8] Leonard Edwards Let’s End Quasi-Jail for Kids – California Youth Authority Rife with Problems. San Francisco Chronicle, May 23, 2004. [Attached]

[9] Shawna L. Parks Innocence Lost: Mental Health Care and the California Youth Authority, American Bar Association. Human Rights Magazine. http://www.abanet.org/irr/hr/spring03/innocencelost.html [Attached]

[10] Don Thompson. Senators want ‘Chad’ locked up: Lawmakers say Youth Authority has not made any improvements to the Stockton facility, Associated Press, June 22, 2005. [Attached] http://insidebayarea.com/portlet/article/html/fragments/print_article.jsp?article=2816525

[11] 45 CFR 46.409 (Wards) states: (a) Children who are wards of the State or any other agency, institution, or entity can be included in research approved under 46.406 or 46.407 only if such research is:

1. related to their status as wards; or

2. conducted in schools, camps, hospitals, institutions, or similar setting in which the majority of children involved as subjects are not wards.

[12] Prisoners may be used in medical experiments only if they "have the intent and reasonable probability of improving the health or well-being of the subject." See Code of Federal Regulations: 46 CFR 46.302

[13] California Penal Code section 3502

[14] Sterngold, J and Martin, M. Hard Time: California’s Prisons in Crisis

High price of broken prisons Tough sentencing creates overcrowding that endangers inmates, haunts taxpayers, San Francisco Chronicle, Sunday, July 3, 2005, pl A-1 [Attached]

http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2005/07/03/MNGLMDIMOT1.DTL

[15] At a conference in Atlanta, attended by IRB and research coordinators, a debate ensued about the whether the requirement for the approval of research conducted on prisoners meant that a prisoner, not prison staff must be present during the discussion. Several IRB members in the audience exclaimed that they would be uncomfortable.

[16] Attached, Report of Inspector General and other documents

[17] Marc Kaufman. Clinical Trials of Drugs Fewer, Study Says Report Also Notes Decline in Number of Principal Investigators in U.S. Washington Post Wednesday, May 4, 2005, A02. [Attached] Indrajit Basu. India’s clinical trials and tribulations Asia Times. July 27, 2004. [Attached]

See: https://ahrp.org/infomail/05/05/04a.php and https://ahrp.org/infomail/04/07/27.php

[18] Tudo Lemmens and Paul Miller. The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives, Journal of Law, Medicine & Ethics. ( 2003) Volume 31, no. 3:398-418

[19] The name of a book by Jerome Kassirer, MD, former editor of The New England Journal of Medicine. See: Kassirer, On the Take: How Medine’s Complicity with Big Business Can Endanger Your Health. Oxford Press, 2005.

[20] Department of Health and Human Services, Office of Inspector General, Recruiting Human Subjects: Pressures in Industry-sponsored Research (2000): at 8, 25. Cited by Lemmens.

[21] Federal investigations found that IRBs failed to:

(a) assess the scientific merit or design of experiments involving human subjects – spending only one to two minutes evaluating proposals before approving them;

(b) assess the legitimacy of using vulnerable human subjects in specific research protocols;

(c) assess the risks and/or hazards for human subjects;

(d) provide any on-going review or oversight once research has begun;

(e) examine serious adverse event reports, except deaths.

[22] Mike Ward and Bill Bishop Whiff of Oversight: Healing or harming, medical tests rarely held up to scrutiny, American-Statesman, Monday, December 17, 2001 [Attached] http://www.statesman.com/specialreports/content/specialreports/prisons/17prisonoversight.html

[23] General Accounting Office (GAO). 1996. Scientific Research: Continued Vigilance Critical to Protecting Human Subject GAO/HEHS-96-72. Washington, D.C.: GAO; See also, 3 critical reports by the Office of Inspector General (OIG), DHHS. 1998a. Institutional Review Boards: A Time for Reform. OEI-01-97-00193. Washington, D.C.: DHHS; 1998b: OEI-01-97-00192; 1998c: OEI-01-97-00190.

[24] See: Grimes / Higgins v Kennedy Krieger (Johns Hopkins) # 128 and #129, Maryland Court of Appeals, August 16, 2001, online at: http://www.law.uh.edu/healthlaw/law/StateMaterials/Marylandcases/grimesvkennedykreiger.pdf . Attached are OHRP letters of determination re: violations of prison research: University of Texas Medical Center, Galveston July, 2000; September 2000; University of Illinois, Chicago, September 2000; Yale University, July 2000; University of Florida, September 2000; Letter of determination re: foster care children AIDS Phase I & II: Columbia University, May 2005 .

[25] John Solomon. Researchers Tested AIDS Drugs on Children Associated Press, May 4, 2005 at: https://ahrp.org/infomail/05/05/04.php June16: OHRP preliminary letter of investigation, May 2005 [Attached] or at: http://www.hhs.gov/ohrp/detrm_letrs/YR05/may05c.pdf AHRP letter of complaint to FDA & OHRP, March 2004 [Attached] or at: https://ahrp.org/ahrpspeaks/HIVkids0304.php

[26] OHRP letter to University of Texas Medical Center at Galveston, July 2000: http://www.hhs.gov/ohrp/detrm_letrs/jul00c.pdf [Attached]

[27] OHRP letter, Septtember 14, 2000: http://www.hhs.gov/ohrp/detrm_letrs/sep00b.pdf [Attached]

[28] Department of Health Education and Welfare, Children’s Committee recommendation. See 28 Fed. Reg. 31, 738 (1973)