Study of the Natural Course of Schizophrenia with SelfHelp Supports

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The Hepatitis Studies at Willowbrook
A Case Study
2
Hepatitis studies were conducted at the
Willowbrook State School for children with mental
retardation from 1956 1971. Hepatitis was a
major problem at Willowbrook. Given the
unsanitary conditions that the children lived in,
it was virtually inevitable that children would
contract Hepatitis. This further added to
stigmatization of the children, a good number of
whom became carriers (and later were reintegrated
into public schools). Krugman, the principal
investigator, proposed research that appeared
promising in distinguishing between strains of
Hepatitis and in developing a vaccine. However,
his study design involved feeding children local
strains of live Hepatitis i.e., deliberately
infecting them.
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Krugman argued that the development of a vaccine
would outweigh the anticipated minor harms to
these children. He also argued that they were
bound to be exposed to the same strains under the
natural conditions they would be admitted to a
special well-staffed unit where they would be
isolated from exposure to other infectious
diseases they were likely to have only a
sub-clinical infection followed by immunity to
the particular hepatitis virus and only children
with parents who gave informed consent would be
included.  As an IRB member, would you approve
this study as designed? If not, why? Would you
request changes to the study or simply urge that
it be abandoned?
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Study of the Natural Course of Schizophrenia with
Self-Help Supports

• A Case Study

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• The New York Times has reported that a government
  sanctioned non-therapeutic experiment aimed at
  compiling data on the effects of the spontaneous
  evolution of schizophrenia with peer supports has
  been proposed by the Public Health Service.

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Research Hypothesis

• Researchers hypothesize that those persons who
  receive no traditional treatment for mental
  illness will show better outcomes and
  satisfaction over their lifetimes than those who
  remain within the mental health system.

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Research Significance

• Many advocates, mental health consumers, and
  researchers have suggested that people with
  mental illness suffer more from the disabling
  effects of psychotropic medications,
  institutionalization, and other treatment
  modalities such as ECT than from the disease
  itself. In fact, recent studies of recovery have
  indicated that people can and do live meaningful
  lives within the community without traditional
  biomedical treatments.

8
Research Significance

• Since the Hippocratic Code instructs physicians
  to Do no harm, scientists and mental health
  consumers argue that it is important to finally
  determine if current approaches to the treatment
  of people with schizophrenia are iatrogenic. Are
  the evidence based practices based on a legacy of
  biased science that values reduction in symptoms
  and social control over the desires of mental
  health consumers for an end to involuntary
  treatment and the nurturing of personhood,
  well-being and self-determination?

9
Methodology

• Proposed study to document the natural history of
  schizophrenia.
• Six hundred people diagnosed with a first
  psychotic break (400 experimental and 200
  controls) are to be recruited into a life-long
  study. The control group members will receive
  standard treatments for schizophrenia the
  experimental group members will receive no
  traditional mental health treatment.
• However, experimental group members will be
  allowed to participate in peer support and other
  self-help activities if they choose to do so. A
  crisis hostel managed by mental health consumers
  will be funded to provide support and care during
  psychotic episodes.

10
Study Incentives

• As incentives, study participants will be offered
  free medical care, transportation, food, and a
  life insurance policy to be paid to their
  survivors.
• Certificates of appreciation will also be sent by
  the Surgeon General of the United Stated to
  encourage participants to remain in the
  experiment.

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Key Personnel

• The studys principle investigators are
  government physicians and psychiatrists
• Several mental health consumers will also be
  working as study consultants, coordinators and
  surveyors

12
Ethical Issues and Actions

• Because of public outcry from families of people
  with mental illness and mental health providers,
  a review panel of researchers, bioethicists,
  mental health consumers and family members has
  been convened to debate the ethical issues
  involved in conducting such an investigation.
• As a member of the review panel, would you
  support the study?
• What ethical issues would you identify in making
  your argument?