Posted by Denise on September 25, 2004, 7:31 pm Medical researchers were aware that Joseph suffered from schizophrenia, when they gave him cocaine. What reaction would they get from him? Would he have "flash backs"? A psychotic relapse? Physical or psychic pain? Would it drive him into a suicidal state? All they really wanted to know was: would it lead to the discovery of a new drug? In an attempt to "cure the ills" of society, pharmaceutical companies rely on human research to test their new drugs. Problems arise, however, when vulnerable patients, like the mentally ill, become unwitting "martyrs for science." This segment of the population often endures ill-conceived, peer-approved, yet highly speculative, experiments. The results serve the interests of the investigators and their academic institutions, but undermine the best medical interests of the subjects, often causing them profound harm. This was true for Abby, a young woman who suffered from Tourette's syndrome, a debilitating mental illness, manifesting itself with physical disabilities. Researchers managed to convince Abby their new drug was going to provide great relief from her symptoms. In order to test the new drug, however, Abby was required to abstain from taking her current, stabilizing medication. According to Judith Vukov, Abby's mother, after 54 days without medical supervision or care, Abby died. "We found out there was no doctor or nurse during the final days of her life. They were supposed to go in every day. Nobody was there to check up on her," said Ms. Vukov. "I'm not against research. I am against negligent research, and that's what they do today," she added. Abby's case is not an isolated event. Wholly non-therapeutic, high-risk experiments using drugs of abuse such as: amphetamine, methylphenidate, ketamine, cocaine, and others, are being conducted on disabled persons, including veterans. Such experiments induce psychotic relapses, loss of functioning, physical and psychic pain, as well as possible long-term harm. For example, at West Haven (Connecticut) VA Medical Center, 18 stable patients living in the community but suffering from schizophrenia, were recruited into an experiment where amphetamine was intravenously injected. The researchers knew the risks. Amphetamine is a potentially toxic drug of abuse, inducing the emergence or worsening of psychotic symptoms. The purpose of these experiments, however, was to take photo images of these patients' brain receptors during a psychotic episode. In another experiment, several patients suffering from schizophrenia at the Maryland Psychiatric Research Center, were administered ketamine intravenously. This drug, a PCP derivative used as veterinary anesthetic, is known to produce hallucinations, recurring delirium, violent responses, and increased blood pressure. Even researchers who conducted the experiment acknowledge, "Ketamine intensified each patient's specific underlying psychosis and induced dissociated, catatonia-like states." Then there were the 48 mentally disturbed patients on Long Island, whose schizophrenia symptoms were in remission before the experiment, in which, on four accasions, all were intravenously administered methylphenidate. All but five relapsed during the 52-week experiment and follow-up period. One patient disappeared, and was designated by the researchers as 'lost.' Why do this? The obvious question is why would someone inflict pain and injury on another human being, especially the helpless who already suffer? The researchers know there isn't any likelihood such experiments would benefit the patients, who are subjected to them. The stated purpose of such experiments is to learn about the physiological mechanisms of schizophrenia, by observing and recording photographically (using MRI, PET and SPECT scans) in order to study the effects of psychosis on these patients' brain receptors. Overall, these inhumane and risk laden experiments exploit the mental disability of vulnerable human beings who have no defense. Such inhumane experimentation in the name of scientific progress is a reflection of the pervasive culture among researchers. They believe these patients are a burden to society and therefore have "a moral imperative" to be subjects of scientific research. Although it may be true that human research is necessary for the advancement of medical care, those who suffer from mental illness should not become the sacrificial lambs. I challenge the presumption that all research necessarily leads to benefits, either for individuals or for society. Indeed, questions are being raised about the efficacy of many psychiatric drugs (including anti-depressants and anti-psychotics) touted as "breakthroughs." The laudable goal of gaining knowledge that will hopefully benefit others is not a sufficient reason to conduct human research on persons prevented from exercising their human right to refuse. Brother's keeper The question before us is whether or not mentally disabled patients are capable of making self-serving choices, and are they able to exercise their right to refuse to take part in medical experimentation. If not, who can be entrusted with that decision? Not all mentally disabled persons are incapable of making some decisions. It is not unreasonable, however, to assume anyone floridly psychotic or institutionalized, because they are incapable of caring for his/her daily needs, is unlikely to have adequate capacity to make rational decisions about complex research consequences. A MEDLINE search reveals, there are literally hundreds such experiments conducted at academic medical research centers across the nation. Many times it is the legal caretaker of the mentally disabled person who gives permission for human experimentation to take place. This creates a whole new set of concerns. Sometimes caretakers, in an attempt to procure good medical care for the patient, are tricked into believing medical experimentation might be a way to access expensive health care. Unfortunately, research investigators rarely disclose all known and potential risks involved for subjects, or disclose the financial rewards they stand to gain from recruiting such patients. It is unseemly for anyone to sign for another human being, bearing the burden of risks involved in biomedical research. This is especially true with non-therapeutic research that puts those human beings at risk of harm, with no possible benefit. Currently, there is no accountability on the part of anyone for what happens to the human subject of research. Conflict of interest History has taught us hard lessons regarding human experimentation. The horrors committed by Nazi physicians and researchers during World War II prompted the development of the Nuremberg Code, which defines the ethics of modern medical experimentation utilizing human subjects. The Code does not waffle about the absolute right of every human being not to be experimented on, unless they give voluntary, informed, comprehending consent. The 1947 Nuremberg Code was augmented by the 1964 Declaration of Helsinki, which added the provision that "the interests of science and society should never take precedence over considerations related to the well-being of the subject." In the U.S., public outrage, following the revelations of abuses in experiments, led to the 1978 adoption of the Belmont Report. The report mandated the establishment of local Institutional Review Boards (IRB) to protect, evaluate, and approve the rights and interests of human subjects. Federal reports, however, indicate that IRBs serve the interests of researchers and institutions, not the human subjects-as was intended. Also, a deluge of recent abuses, reported in the media, demonstrate that vulnerable patients are being harmed irrevocably. These facts demonstrate the need for a national Human Subject Protection Act, with independent oversight mechanisms to protect human subjects from further abuse. Not surprisingly, those most at risk of abuse are vulnerable, mentally disabled persons who are incapable of protecting themselves. In December 1998, the National Bioethics Advisory Commission, appointed by President Clinton, issued a report outlining its recommendations. While recognizing that problems exist in experiments that exacerbate psychotic symptoms in patients, they recommended that these experiments be reviewed by the Institute of Medicine, whose members include the very researchers who conduct such unethical experiments. Where are we headed? The pace and volume of questionable human experimentation have already increased and rapidly accelerated in both the industrialized and non-industrialized countries. Without the moral and political will to establish meaningful safeguards and enforcement mechanisms to guarantee their implementation, everyone is at risk of becoming a human guinea pig sooner or later. Today it is the mentally ill who become a commodity for furthering the research enterprise, offering huge financial rewards to all involved-except the individual subjects. Thanks to a laissez faire, profitable market in human experimentation, the mentally ill are but the most accessible subjects of abusive experimentation. The question before us is
who is next? Celebrate Life - Jan/Feb 2000 - http://www.all.org/celebrate_life/cl0001c.htm Vera Sharav is the President of AHRP - Alliance for Human Research Protection - http://www.ahrp.org/
205.158.33.30
Like lambs to the slaughter
by Vera Hassner Sharav
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