Ethics Case Study:

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Ethics Case Study Health Care Provision in a
Vaccine Efficacy Trial
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Vaccine Case Study

• Viracept, a small UK-based biotech company has
  developed an experimental HIV vaccine that
  appears effective in lab and animal studies
  against clade C the virus circulating in
  Vietnam
• Viracept plans to collaborate with Vietnamese
  Vaccine Institute (VVI) a government run
  research enterprise to conduct a phase III
  efficacy trial among IDUs in Ho Chi Minh City.
• The costs of the study are being covered by
  Viracept, a grant from the UK government and
  contributions in kind by the Vietnamese
  government.
• Viracept and the VVI agree that anyone who
  seroconverts during the study will be referred to
  a government hospital and treated according to
  the standard methods published in the Ministry of
  Public Health Document, Guidelines for the
  Clinical Management of HIV Infection.

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Case Study (continued)

• Vietnamese treatment guidelines provide for
  psychosocial support, nutritional
  supplementation, TB prophylaxis and treatment for
  opportunistic infections They do not currently
  include ART
• Viracept agrees to provide treatment for the
  lifetime of seroconverted patients, according to
  the standards in place by the government at any
  moment in time.
• The protocol of the study is reviewed and
  approved by the ethical review board of the
  Vietnamese Ministry of Public Health, the British
  MRC, and reviewed and commented upon by UNAIDS.
• After the study has begun, an article condemning
  the study appears in the local newspaper, arguing
  that the study is unethical because it does not
  provide state of the art care for individuals who
  become infected during the trial

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Questions

• In your opinion, is the study unethical because
  participants are not being offered the best care
  available in the world if they become HIV?
• What ethical principles are involved in your
  decision?
• Would guaranteeing ART to those who seroconvert
  during such a trial (when similar treatment is
  not available locally) constitute an undue
  inducement? How would you decide?
• If the developer of the vaccine was a Vietnamese
  researcher who wished to conduct the study in his
  own country, would you view the use of the best
  available local therapy differently?

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Plot Twist

• Before finalizing its protocol the Vaccine
  Institute hired a social worker to conduct
  community meetings with IDUS and their sexual
  partners about the upcoming study. She notes
  that the Viracept company has agreed to put
  300,000 in a community fund to benefit the IDUs
  who agree to participate in the study. She lays
  out a number of options of how this money might
  be spent, including setting up a fund to
  guarantee access to ART for those individuals who
  seroconvert during the trial.
• After much discussion, the group decides that a
  better use of the Viracept money would be to help
  establish a local treatment program for IDUs
  one that could be accessed both by trial
  participants and others outside of the trial.
  Our boyfriends need help now, several women note.
  What good is it to us to let them get infected
  and then guarantee them drugs ten years from now?

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Plot Twist Questions

• Does this plot twist change your assessment of
  the ethics of the trial?
• What if community members had voted to take a
  trip to Bangkok with the money, would that have
  been an ethically acceptable outcome
• Are there any other services that should be
  provided to the IDU population

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Plot Twist 2

• 7 months into the trial, PEPFAR monies enter
  Vietnam and limited access to ARVs begins to
  become available. Trial investigators propose to
  refer those who seroconvert during the trial to
  PEPFAR funded treatment programs and arrange that
  those who are HIV positive at screening be given
  preferential access to PEPFAR drugs.
• A local HIV positive group publishes .a letter
  protesting this policy questioning why people who
  get tested at trial sites should jump the cue
  for access to treatment.

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Plot Twist Questions

• Do you think that people who are found to be HIV
  positive at screening should be guaranteed access
  to ARVs? Why or why not?
• Is it fair that someone who finds out their
  status at a trial site would get access to ARVs
  when their neighbor who tested at a local VCT
  clinic would not?