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Nov./Dec. 1998

'At the mercy of overzealous researchers.'   Media hasn't put 2 and 2 together, says Steve Drake.     Maryland statute group part of growing trend Guinea pigs don't get to say 'no' by Mike Ervin Mike Ervin writes for the Disability News Service. © Copyright 1998 The Disability News Service, Inc.   Safeguards for "decisionally incapacitated" subjects of medical experiments questioned as Maryland ponders passing new law Every now and then a shocking story surfaces about unwitting subjects of outrageous medical experiments. An infamous example is the Tuskegee experiments which came to light in the 1970s: African American men diagnosed in the 1930s with syphilis had been intentionally left untreated in order to study the disease's progress. Such appalling research continues today. In one recent study, children from predominantly minority populations were given the drug fenfluramine in order to study the drug's effect on children's brains to determine if they were at high risk for anti-social behavior. In exchange for participating in the study, the parents received $100 and the children received $25 gift certificates to Toys 'R' Us. (Last year, the Food and Drug Administration [FDA] took fenfluramine off the market because it caused heart disease in some people who were using the drug as a diet pill.) Victims of dangerous research are almost always the politically vulnerable--the poor, people of color, people incarcerated in prisons and mental institutions, or people with mental disabilities and children, says Dr. Adil Shamoo of the Department of Biological Chemistry at the Medical School of the University of Maryland at Baltimore. Abuses are no accident, says Shamoo. Researchers who recruit subjects in secret and under less-than-honest pretenses know exactly what they're doing: Few people knowingly expose themselves to these types of experiments. Among the politically vulnerable are people incapable of making an informed decision for themselves about whether to be a human subject for medical research--people referred to as "decisionally incapacitated." All across America, experiments are being conducted daily on decisionally incapacitated people, says Shamoo. "The attitude of current psychiatric researchers is no different from those who conducted the Tuskegee study," he says. For the last three years, a working group assembled by the Maryland attorney general has grappled with drafting legislation to protect the rights of "decisionally incapacitated" people, while recognizing the "need" to conduct medical research on human subjects. The group completed its work in June and released a proposed bill for public comment. Their proposed statute would significantly enhance the rights of human subjects, and would be a decided improvement over the essentially unregulated status quo, says the group, although not all members are in agreement over various points. The attorney general will decide whether or not to push for introducing the bill when the legislature convenes in early 1999. Shamoo, who was a member of the working group, says the bill being proposed will improve the situation only moderately. "Vulnerable uncomprehending human subjects . . . will continue to be used as guinea pigs," he says in his published dissenting opinion to the report. Shamoo says he personally objects only to research with decisionally incapacitated people when it presents "greater than minimal risk" for the patient and promises no direct medical benefit. Such research, he says, should be done only in "extreme, unique and rare circumstances." "When it comes to protection from zealous researchers, animals have more rights than people," says Vera Hassner Sharav, director of Citizens for Responsible Care in Psychiatry and Research in New York City. Sharav sounded the alarm on the fenfluramine study. While she did not participate in the Maryland working group, she has reviewed the draft and believes it doesn't go far enough to protect people who are decisionally incapacitated. Using people unable to give informed consent due to mental disabilities is a lucrative business, according to Sharav.   Shamoo has written and lectured extensively on the ethics of medical experimentation on humans. One of the main problems he and Sharav share regarding the proposed Maryland bill is that it puts too much power in the hands of the institutional review boards that monitor and approve medical research projects. As many as 5,000 institutional review boards can be found across the country. Most are affiliated with hospitals and academic centers, but also exist within managed care organizations, government agencies such as the National Institutes of Health, the Centers for Disease Control and Prevention and state governments, and in for-profit entities independent of the institutions in which the research takes place. The Department of Health and Human Services' Office of Protection From Research Risks (OPRR) at NIH oversees institutional review boards. Federal regulations require that boards have at least five members--at least one must have primarily scientific interests, one must have primarily non-scientific interests and one must be otherwise unaffiliated with the institution in which the institutional review board resides. Despite ethical questions about subject selection and lax informed consent procedures, the fenfluramine study received HHS and institutional review board approval. Under the provisions of the proposed Maryland law, all research involving subjects who can't give informed consent would have to be approved by an institutional review board. Shamoo says this is potentially full of conflicts of interest, since institutional review boards also may consist of people directly involved with the research institutions. Sharav, too, says that entrusting institutional review boards with oversight is dangerous because even those with honest intentions are not always fully informed by the researchers. She points to an April memo from OPRR to the dean of the University of Maryland Medical School noting that a review of the protection of human subjects at UMB's Maryland Psychiatric Research Center found a number of instances where UMB institutional review boards either lacked sufficient information to make judgments required by the HHS regulations--or did not follow the procedures required by the HHS regulations. OPRR said institutional review board members must receive immediate education regarding special protections for vulnerable populations. Maryland's proposed law "is an improvement over the status quo," says Jack Schwartz, chief counsel for the Maryland attorney general. Schwartz assisted the working group in drafting the proposed legislation. "Any law that seeks to be fair on the issue of research on those who cannot give informed consent is not likely to totally please proponents or opponents," he says. The mission of the group was not to rewrite federal regulations about institutional review board membership--or whether or not the decisionally incapacitated should be enrolled in riskier research with no direct benefit, according to Schwartz. The question left to the states is "Who is the legally authorized representative [of those who cannot decide for themselves]? That's what we attempted to define." Schwartz says the statute should prevent secret experiments by requiring that institutional review boards make available minutes of their meetings to anyone requesting them. He also explains that the statute provides safeguards to protect the decisionally incapacitated from being enrolled in research with "greater than minimal risk" and "no direct benefit." Permission to participate must be spelled out in a "research advance directive" that, among other things, designates a representative to make medical research decisions in the event the person is decisionally incapacitated. Even then, the person designated to make these medical decisions must consent, and an impartial medical observer must affirm that the consent was well informed. Sharav thinks informed consent can be a charade, though, pointing again to the OPRR memo. While OPRR found that the Maryland Psychiatric Research Center's informed consent form did generally comply with HHS regulations, the agency stipulated that certain deficiencies be corrected. The consent forms, said OPRR, did not always adequately define research risks; describe the benefits to the subject; review the availability of alternative treatments; note whether or not procedures were experimental or define the individual's ability and right to refuse to participate in or withdraw from research. Shamoo worries that the proposed Maryland law lacks legal recourse for research subjects, because it grants researchers immunity from prosecution if they the law in their use of "decisionally incapacitated"subject. Schwartz points out, though, that the statute "expressly preserves" the right to "take action" for medical negligence. Sharav believes the only fair thing to do is to declare a moratorium on using people who are decisionally incapacitated as subjects in research that has higher than minimal risk and is of no medical benefit to them. The moratorium can be lifted, she says, when a federal law protecting them is passed--a law similar to the federal law that protects animal research subjects. A human subject protection bill was introduced in 1997 by Senator John Glenn (D-Ohio) but has gone nowhere. Last summer Rep. Christopher Shays (R-Conn.), chair of the House Subcommittee on Human Resources, held hearings on institutional review boards. Shays and Rep. Edolphus Towns (D-N.Y.) have introduced federal legislation that would monitor research programs involving people with mental disabilities and children. Those testifying at Shays' hearings included B. Timothy Walsh, M.D., co-chair of the New York Psychiatric Institutešs institutional review board from 1990-1997, when it conducted the controversial fenfluramine study. and Institute director John M. Oldham, M.D. In their testimony, the two doctors stated that the Institute's review board had "carefully applied the federal regulations governing research and the ethical principles on which they are based."   Problems with institutional review boards They: review too much, too quickly with too little expertise; conduct minimal continuing review of approved research; ignore conflicts that threaten their independence; and provide little training for investigators and board members. From Institutional Review Boards: A Time for Reform, report prepared by HHS Inspector General June Gibbs Brown released in June 1998. The report criticized both institutional review boards and agencies such as The Department of Health and Human Servicesš Office of Protection From Research Risks and the Food and Drug Administration for not devoting enough attention to evaluating the effectiveness of institutional review boards.   High-risk, painful research inflicted on 'decisionally incapacitated' people 'At the mercy of overzealous researchers Individuals should only be used as research subjects when it is in their best medical benefit. Only under extreme, unique and rare circumstances should we use this population for research without direct medical benefit to them. . . . We should not design disguises such as "advance [research] directives" in order to use people in research--especially vulnerable subjects such as [people who are] mentally ill. . . . Uncomprehending patients . . . are currently at the mercy of overzealous psychiatric researchers who claim a "moral imperative" to conduct high-risk, painful experiments on uncomprehending patients in the name of "science." The attitude of current psychiatric researchers is no different from those who conducted the Tuskegee study . . . The number of mentally disabled victims who have been used in recent years in the U.S., including Maryland, without their ability to comprehend the nature of these invasive, high-risk, often painful experiments (and who could not, therefore, give their informed consent) surpasses the number of those who were victimized in the Tuskegee Syphilis and radiation exposure experiments. . . . From A Dissenting Statement by Adil E. Shamoo, Ph.D. Shamoo is Editor in Chief of the journal Accountability in Research, June 12, 1998.   Easing of FDA rules may have led to deaths Media hasn't put 2 and 2 together, says Steve Drake Last April 1, an Associated Press article that was not a joke began, "A pharmaceutical company abruptly halted its study of a blood substitute in U.S. emergency room patients after discovering they were dying at a higher rate than expected." "This news was of interest to me because of another story, from November 5, 1996," says Steve Drake of Not Dead Yet. On that day, the New York Times's Gina Kolata had reported on the U.S. Food and Drug Administration's easing of requirements that informed consent be obtained for enrollment in trials of experimental medical procedures. "For the first time in a half century, new federal regulations allow investigators to enroll patients in some medical research studies without their consent," wrote Kolata. "The Food and Drug Administration regulations, which took effect on Friday, apply only in carefully circumscribed situations. The patients must have a life-threatening condition, like a severe head injury, and must be unable to say whether they want to be part of a study. They would be selected only if it was not feasible to obtain consent from a relative." "TV coverage of this FDA change at the time indicated that experimental use of artificial blood would be one of the first applications of this rollback of the Nuremberg Code," said Drake. In her article, Kolata explains that this Code "dates back to the Nuremberg trials of Nazi doctors after World War II, when American judges were agonizing over rules that might prevent doctors from ever again using human subjects in horrendous experiments. "The judges wrote a code of ethics, the Nuremberg Code, whose first principle was that no one should ever be forced to take part in a medical experiment," wrote Kolata. "The voluntary consent of the human subject is essential," says the Nuremburg Code. "The leader of the group of bioethicists who quietly lobbied and won the FDA changes," says Drake, "was Norman Fost, the first recipient of the funded chair at Princeton that Peter Singer will now hold." (See "Peter Singer appointment draws warning," D.R. Nation, September/ October). At the time of the FDA change, Fost was Director of the Center for Clinical Ethics at the University of Wisconsin. "We are seeing a worldwide trend in the use of 'nonconsenting subjects,'"says Drake. "A few years ago, most of the European community signed onto a new set of research guidelines that allows incapacitated people (people with mental retardation, in 'persistent vegetative states' or in comas) to be 'enlisted' in research not of direct benefit to the subjects." "No press coverage seems to have put the earlier story together with the April 1 news," says Drake, "but it seems highly likely that the people in the artificial blood experiment gone bad were 'enrolled' in this research project without their consent--and that a number of people may have died as a result of getting the artificial blood." "Given that the subjects are now dead (and evidently do not have next of kin), it is unlikely there's worry of lawsuits regarding wrongful deaths in this scenario," says Drake. "Convenient, isnšt it? "Is there going to be a re-evaluation of the wisdom of this exception to the requirement of informed consent?" asks Drake. "Or is it still ethical, due to the fact that the press hasn't caught on and there will probably be little danger of litigation resulting from the deaths of unwitting participants?" "One would think that the early termination of studies involving nonconsenting subjects would have been newsworthy--yet it received scant attention from the press," Drake continues. "No coverage of the discontinued study tied it to the FDA informed consent exemption." "According to investigative reports from a couple of years ago, the FDA's own data indicate that about half the medical researchers they have monitored (after the fact) had significant problems in terms of documenting informed consent or giving enough information so that consent could be truly informed," Drake adds. "It seems we are giving further powers to a group that has a shitty track record of obeying already existing rules."   Back to table of contents