Ethical Issues in Public Health Research--June 3-6, 2003--Sofia, Bulgaria
   
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Non-Communicable Diseases, Mental Health, Drug Abuse

Case Study #1: Section 1 2 3 4 5

1. Background about the economic, social and political context in the country(ies) in which the study is being planned or conducted.

Technovy, the hypothetical country, has only recently divested itself, through violent revolution, from the rule of a despot. Under his rule, the Technovy’s economy was artificially inflated, allowing its citizens to purchase goods and services at unrealistically low prices. Since his overthrow, the country has attempted to institute capitalism and democracy. The majority of the populace remains relatively poor, and the much of the country’s wealth is held by a small minority. The most intelligent of the educated young adults are leaving the country to seek more lucrative employment opportunities abroad, as the award of any professional position is often dependent upon political connections, rather than merit. Many individuals, including highly educated professionals, must work two or three jobs to earn sufficient money to support their families.

Although the country once had a nationalized health care system, the health care system has recently been reorganized and has become employment-based. The government is now finding that there is an inadequate economic base via this mechanism to support medical care for those who are unemployed, such as children, the elderly, and the institutionalized, in addition to those who are employed. As a result, many individuals are receiving suboptimal care. Although hospital stays appear to be cost-free because they are paid for from this national fund, patients must pay for their medications and procedures. Recently, several physicians were arrested and charged with criminal offenses for demanding payment from their patients in addition to that provided to them through the government insurance scheme.

The church is extremely strong in Technovy and has condemned abortion and alternative lifestyles, such as cohabitation without the benefit of marriage and homosexuality. Women, in particular, are disadvantaged socially, politically, and economically. There is a high rate of alcoholism in Technovy, particularly among the men, but it has not been recognized as a public health problem. There is an increasing incidence of substance abuse, particularly of heroin, as Technovy is en route between a major heroin supplier-nation and a major distributor-nation. The incidence and prevalence of partner violence and child abuse are extremely high, but have only recently been acknowledged by health authorities. In general, women and children have little recourse if they suffer from family violence and there are few shelters throughout the country. Individuals of minority groups, those suffering from HIV, and those suffering from mental illness are often stigmatized due to their ethnicity and/or disease.

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2. Information about the disease or specific problem being addressed by the research.

Although schizophrenia is believed to be ubiquitous, its current prevalence varies widely, from 1 in every 1,000 persons in non-Western societies to more than 1 in every 100 in Western societies. To some extent, variations in prevalence rates may exist due to variations in diagnostic criteria and sampling methods. There is considerable disagreement among mental health professionals with respect to the recency of the disorder’s appearance, with some arguing that schizophrenia has existed since classical times, and others contending that it is a phenomenon of relatively recent origin. Schizophrenia has been found to be relatively uncommon in locations that do not have a system of wage labor, although the reasons for this remain unclear.

A diagnosis of schizophrenia in North America and Europe is currently guided by the criteria contained in the fourth edition of the Diagnostic and Statistical Manual (DSM-IV).These include the experience of two of the following for a significant period of time during a one month interval: (1) delusions, (2) hallucinations, (3) disorganized speech, (4) grossly disorganized or catatonic behavior, and/or (5) flat or grossly inappropriate emotional tone. Only one such symptom is required for diagnosis if the individual has experienced bizarre delusions or hallucinations that consist of a voice that makes a running commentary on the individual’s behavior or thoughts, or of two voices conversing with each other. These symptoms must have resulted in decreased functioning in social relations, work, or other areas of life. In addition, various other possible diagnoses and factors that might explain the behavior, such as an autistic disorder or drug intoxication, must have been ruled out.

Subtypes of schizophrenia include (1) the paranoid type, characterized by a preoccupation with one or more delusions or frequent hallucinations; (2) the disorganized type, in which disorganized speech, disorganized behavior, and flat or inappropriate affect are prominent features; (3) the catatonic type, in which two or more of the following features are predominant: motoric immobility, excessive motor activity, extreme negativism, peculiarities of voluntary movement, and echolalia or echopraxia; (4) the undifferentiated type; and (5) the residual type, characterized by the absence of prominent delusions, hallucinations, disorganized speech, and disorganized or catatonic behavior, as well as the presence of negative symptoms or two or more of the five diagnostic criteria. Continuous signs of the disturbance must be present for at least six months to support a diagnosis of schizophrenia.

Positive symptoms constitute distortions of normal functions, and include hallucinations (distorted perceptions), delusions (distortions in cognitive and inferential thinking), positive formal thought disorders (distortion in language), and bizarre behavior (distortion of behavior organization and control). Negative symptoms represent a decrease or loss of normal function and may include affective blunting, avolition, anhedonia, and attentional impairment. Individuals suffering from schizophrenia have invariably described the disease and its symptoms as frightening, incomprehensible, and cruel.

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Factors found to be associated with the onset and distribution of schizophrenia include various demographic characteristics.25 Researchers have consistently found an inverse relationship between social class and schizophrenia.26 Two competing hypotheses have been proffered to explain this apparent link. The first, known as the selection-drift hypothesis, posits that individuals who are prone to schizophrenia are either prevented from attaining a higher social class level (selection) or, as a result of the disease symptoms, move progressively downward (drift). This hypothesis is premised on the observation that the onset of the disease is often insidious and frequently commences during adolescence, when social skills are often acquired. The second theory asserts that various exposures that may precipitate the onset of schizophrenia, such as infectious agents, increased occupational hazards, and increased psychosocial stress, are more prevalent in lower class areas.

Although numerous studies have reported an increased rate of schizophrenia among males as compared with females, it is unclear if this finding actually reflects differences in the rate of hospitalization, rather than the rate of disease. Unmarried individuals have been found to be at increased risk for schizophrenia.

Several conditions have been identified that may serve as predisposing characteristics for schizophrenia. These include birth during the winter months of the year, obstetrical complications, and genetic factors. Several other factors may precipitate the onset of schizophrenia, including significant social stress and urban residence.

Current approaches to the treatment of schizophrenia include the use of antipsychotic drugs, social skills training, and cognitive behavioral therapy. Antipsychotic drugs, in particular, have significantly reduced the severity and duration of psychotic episodes, as well as having lengthened the interval between relapses. However, their use has not been unproblematic. Many individuals experience non-neurological side effects, such as drowsiness, lethargy, and sexual dysfunction. More rarely, antipsychotics may cause liver dysfunction, cardiovascular abnormalities, or a variety of blood disorders. Neurological side effects may include a Parkinsonian syndrome, akathisia, dystonia, or tardive dyskinesia. The occurrence of many of the more severe side effects appears to have been reduced with a number of the newer antipsychotic medications. The prognosis for those diagnosed with schizophrenia varies geographically, with those diagnosed in poorer countries more likely to experience less severe disease and more likely to have a better outcome, apparently due to the enhanced support that the individuals receive from both their families and their communities.

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3. Information about the design of the study.

A physician in an institution wishes to test the use of a drug in institutionalized patients diagnosed with schizophrenia to see if it will control the hallucinations. The drug has not been approved in Technovy or elsewhere for use for this purpose. In fact, the drug is known to initiate psychosis in particularly susceptible individuals. The physician has decided to conduct this experiment by prescribing this nonconventional drug to his individual patients, instead of their regular therapeutic medications, and to monitor the progress of each individual patient. Themajority of his patients are women, who have often been brought to the institution by their family members who are unable to care for them. Many of the women suffered partner abuse while they were living in their homes. He has not designed any form of controlled experiment and has not submitted this plan to any review committee.

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4. Description of the main ethical problem and what is at stake for the affected parties.

There are numerous ethical problems here.

a. The lack of a study protocol, which may increase the risk to the study participants
b. Issues related to the ability of the institutionalized individuals to consent to participate, as a result of possibly impaired cognitive ability and possible coercion associated with institutionalization and dependence on the physician-experimenter for their clinical care
c. The lack of review by an independent reviewing body, such as an institutional review board

5. What are the specific questions that must be asked/resolved in order for the research to be considered ethically acceptable?

a. Is the physician qualified to conduct this study?
b. Has the drug to be tested been properly tested in animal models? Is there reason to believe that it may be efficacious for its intended use? Have toxicity levels been established?
c. Is there another, less vulnerable population in which this drug could be tested first?
d. Will the participants derive any benefit from participation? What are the risks of participation? What is the risk-benefit ratio?
e. Do participants have capacity to consent to participate?
f. Are participants free from duress and coercion? Can they give voluntary consent?
g. Are special protections necessary, if the study is to go forward? What should they be?