trol children, but when they were poor children over here at Columbia University, it was OK. It's just inconceivable to me that you can, that because you're poor, because you have older brothers in trouble, that such experiments can be conducted if they're impermissible to other children. You don't get special rights because you're poor. Thank you very much. Mr. MICA. Thank you. [The prepared statement of Mr. Zucker follows:] December 6, 1999 The Honorable John L. Mica Chairman Subcommittee on Criminal Justice, Drug Policy and Human Resources House of Representatives Committee on Government Reform 2157 Rayburn House Office Building Washington, DC 20515-6143 Dear Chairman Mica: I am Executive Director of Disability Advocates, Inc., a not-for-profit public interest law firm which advocates for the rights and protection of persons with disabilities. For almost ten years, Disability Advocates has advocated for the rights and protection of human subjects of medical experiments, and in particular, the rights of children and mentally disabled human subjects. Children and persons with mental disabilities are least able to protect their rights and well-being as human subjects, and the current protections in federal law are inadequate to protect these vulnerable persons. I. Secrecy of IRB Proceedings Makes it Impossible to Adequately Protect Human Subjects. I appreciate the opportunity to testify at the public hearing on "Do Current Federal Regulations Adequately Protect People Who Participate in Medical Research?" A complete answer to this question will be elusive as long as the conduct of medical research remains cloaked in secrecy. The lynchpin of current protections for human subjects is the Institutional Review Board (IRB) which has the duty to review the conduct of human subject experiments to insure the protection of human subjects. The deliberations and actions of the IRBs occur behind closed doors in the institutions conducting the human subject research. There is no requirement that the IRBS report the nature and risks of the experiments approved and the characteristics of the subject population to any government oversight agency or to the public. As a result, we have little knowledge of what is occurring. Oversight by the Office of Protection from Research Risks (OPRR) is triggered by complaints or reports of adverse incidents, and thus only a tiny percentage of IRB decisions ever come to light or are reviewed. This must change if we are to develop a system to adequately protect human subjects. Federal law should require: research Collection of Data. All entities conducting human research shall Had such reporting requirements been in place, many of the past abuses of human subjects would have been discovered early and remedied by public scrutiny and government oversight. At present, only a tiny percentage of human subject research ever sees the light of day. II. Federal law must be strengthened, as demonstrated by psychiatric drug experiments conducted on the "consent" of floridly psychotic homeless mentally ill individuals. Disability Advocates, Inc.has been investigating research which was conducted at Bellevue Hospital in New York City, conducted by New York University School of Medicine, and funded by Novartis Pharmaceuticals Corporation. The protocol, ILP3000, tests the experimental drug Iloperidone on patients with acute or subacute exacerbation of schizophrenia. We have examined the records of the fourteen patients who were enrolled in the protocol. Each of the subjects arrived at the emergency room in a florid psychotic crisis. Most were homeless. Within hours or days, each floridly psychotic subject was asked to enter the Iloperidone study. There is no indication that any of these subjects had been tried and failed on available non-experimental treatments before being offered experimental treatment. 66-523 D-00--4 The Honorable John L. Mica Collection of Data. All entities conducting human research shall Many of the past abuses of human subjects would have been discovered early and remedied by public scrutiny and government oversight had such reporting requirements been in place. At present, only a tiny percentage of human subject research ever see the light of day. II. Federal law must be strengthened, as demonstrated by psychiatric drug experiments conducted on the “consent” of floridly psychotic homeless mentally ill individuals. Disability Advocates, Inc. has been investigating research which was conducted at Bellevue Hospital in New York City, conducted by New York University School of Medicine, and funded by Novartis Pharmaceuticals Corporation. The protocol, ILP3000, tests the experimental drug Iloperidone on patients with acute or subacute exacerbation of schizophrenia. We have examined the records of the fourteen patients who were enrolled in the protocol. Each of the subjects arrived at the emergency room in a florid psychotic crisis. Most were homeless. Within hours or days, each floridly psychotic subject was asked to enter the Iloperidone study. There is no indication that any of these subjects had been tried and failed on available nonexperimental treatments before being offered experimental treatment. Every subject's case record contains an identical “boilerplate” entry purporting to describe the informed consent process, asserting that all the subject's questions were answered and that “all risks and benefits of participating in this study have been discussed with the patient who understands that participation is voluntary and that they may withdraw consent at any time." Every record has The Honorable John L. Mica December 6, 1999 concurrent notes from clinicians noting that the patient is acutely psychotic and lacking in insight and judgment. In no case is there any attempt to reconcile the concurrent notes describing acutely disordered thinking with the “boilerplate" notes describing an informed consent process which is made to sound calm and contemplative. While the informed consent forms contain a capacity certification by a Bellevue psychiatrist, there is no note or report describing the capacity assessment or explaining why the subject had capacity notwithstanding his or her florid psychosis. In every case, the subject either withdrew because he or she could not tolerate participation, or was terminated by the researchers because the subject was doing so poorly. In no case did the subject derive any benefit. Each subject, to varying degrees, suffered exacerbation of psychotic symptoms due to delay in receiving medication while on the placebo/washout phase or when receiving the drug. On withdrawal from the experiment, all patients were treated with non-experimental drugs that could have been offered upon admission, and many of the subjects shortly improved enough to be discharged. None of the records contains a justification for withholding treatment that was likely to be helpful to these acutely sick individuals.' 'The record of one patient is illustrative. Mr. Doe (a pseudonym) was admitted to Bellevue Hospital in New York City on December 31, 1998. He was eighteen years old and was "acutely psychotic," "floridly psychotic" and "unable to care for self at this time" according the Emergency Admission form. On January 4, 1999, "Pt. denied need for meds or group therapy during AT [activity therapy] orientation." On January 5, 1999, the caseworker states that he "is in complete denial with his illness." A note that day describes him as ""agitated and uncooperative" and states "[h]e has no insight into his illness and exhibits poor judgment...." Notably, a social worker had a lengthy telephone conversation with Mr. Doe's mother on January 5, 1999, but there is no indication in the record that his mother was advised that he was to be asked to participate in an experiment. Later that day, the record states "patient approached staff claiming he was hearing voices." Doe had responded favorably in the past to Risperidone, a non-experimental antipsychotic, but he was not offered Risperidone. Instead, on January 6, 1999 he was asked to participate in the Iloperidone study. Doe's participation was risky for himself and others. The medical records state that since childhood he had heard voices which commanded him to hang and burn a dog, kill a cat by throwing it out the window, attempt suicide, and threaten to poison his siblings. The experiment involved a placebo washout period in which he would receive no medication, followed by either a placebo, Iloperidone, or another medication. Therefore, the experiment offered the possibility of no treatment for an extended period, notwithstanding this dangerous history. |