Pharmaceutical Research

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Pharmaceutical Research
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Pharmaceutical Research

• Kevin Kerns
• Christine Mendes
• Robyn Kobashigawa
• Cynthia Longs

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Pharmaceutical Research

• Background Information
• Case
• Professional Issues
• Legal/Policy Issues
• Ethical Issues
• Stakeholders
• Actions/Consequences
• Final Decision

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Background

• How medical trials are conducted
• Typically consists of control group and a
  variable group
• Control group is given a placebo or the current
  standard treatment
• Variable groups given the experimental drug or
  procedure

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Ethical Standards

• Researchers need to consider whether or not the
  knowledge gained from the trial is worth the
  risks to the subjects
• Research that puts subjects at high risk with
  relatively little chance of benefiting them is
  unethical
• Subjects should be well informed of the risks and
  potential benefits of the trial

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Ethical Standards (Cont)

• Subjects should be participating of their own
  free will

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Case Should heroin addicts receive heroin
prescriptions?

• Most Relevant Facts
• Heroin prescription involves a medical provision
  of heroin to treat heroin addiction
• Used as a mode of treatment in the US since the
  early 1900s
• High rate of HIV transmission among drug users
• Several Western governments and public health
  authorities want heroin prescription to be
  investigated more fully in order to determine if
  it can be used as a safe way of treating
  addiction

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Current Treatment

• Methadone hydrochloride maintenance therapy
• Residential treatment center

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Swiss Heroin Trials

• The Swiss government conducted a study of
  different therapies for treating heroin addiction
  
• 1,146 individuals involved in study from 1992 to
  1996

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People Involved

• Two groups
• Control Group
• Variable Group
• Variable group received injectable heroin
• Control group eligible for other treatment

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Results

• Experimental group injected heroin up to three
  times a day and after 6 months showed a decrease
  in illicit drug use and criminal behavior
  compared to those in the control group
• They showed a decrease in HIV risk behaviors

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Other Conclusions

• WHO
• report stated that improvement in health and
  social status cannot be directly causally
  attributed to the heroin injections alone
• may have been a result of the overall treatment
  program

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Professional Issues

• Researchers/Physicians
• Treating subjects with respect, beneficence and
  justice
• Obtaining informed consent
• Not providing excessive compensation
• Not exposing subjects to excessive risks
• Offering optimal medical care
• Promoting the good of the subject

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Legal/Policy Issues

• Heroin is an illegal drug
• U.S. national policy War on Drugs
• Informed consent of trial subjects required
• Awareness of risks and benefits
• No coercion
• Researchers responsible for harm resulting from
  trials

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Ethical Issues (1)

• Heroin addicts ability to give informed consent
• Uncontrollable desire to seek and use drugs
• Compulsion to use heroin compromises voluntary
  nature of choice
• Intoxication and withdrawal affect ability to
  comprehend choices
• Addiction alters values

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Ethical Issues (2)

• Are resources better off spent elsewhere?
• No we need to find the best medical treatment
• Is heroin addiction a medical or social problem?
• An addicts medical problem, our social problem
• Risk of promoting message that heroin addiction
  is acceptable

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Stakeholders

• Addicts
• Researchers/Physicians
• Taxpayers/Sponsors
• Family/Friends/Community
• Drug Dealers
• Drug Companies

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Possible Actions

• Conduct trials using heroin with a third party
• Conduct trials with low risks and low competence
  expected
• Do not conduct the trials

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Consequences

• A1 - Conduct the trials with surrogate consent
• Participants interest and well-being is
  protected
• Reduced heroin use - Better health
• Reduced HIV risk behavior
• Less criminal behavior

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Consequences

• A2 - Conduct the trials with low risk treatment
• Researchers responsible
• Rely on participants risk knowledge
• Reduced heroin use - Better health
• Reduced HIV risk behavior
• Less criminal behavior

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Consequences

• A3 - Do not conduct the trials
• Not supplying free heroin
• Deny potential for medical treatment
• No treatment could lead to prolonged addiction
  DEATH

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Individual Rights/Fairness

• A1 - Conduct the trials with surrogate consent
• Surrogate protects participant
• Reduced heroin use
• Drug-free life

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Individual Rights/Fairness

• A2 - Conduct the trials with low risk
• Respecting participants autonomy
• Reduce heroin use
• Drug-free life

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Individual Rights/Fairness

• A3 - Do not conduct the trials
• Denying potential treatment to heroin addicts
• Hindering research/technology advancement

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Common Good

• A1 - Conduct trials with surrogate consent
• Protecting and assisting addicts
• Healthy individual less crime

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Common Good

• A2 - Conduct the trials with low risk
• Respecting addicts autonomy
• Treating addicts justly (the surrogate could
  decide not to allow participation)
• Healthy individual less crime

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Common Good

• A3 - Do not conduct the trials
• Hinders medical advancement
• Increase number of heroin addicts
• Does not elevate the common good

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Final Decision

• A1 - Conduct the trials with surrogate consent
• Most good, least harm
• Participants interests and well-being are
  protected
• Treats participants justly by providing treatment