ART and Other Medical Care in the Context of Prevention Trials: Who is Responsible?

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ART and Other Medical Care in the Context of
Prevention Trials Who is Responsible?

• Gregg Gonsalves
• Gay Mens Health Crisis
• New York

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• Those of us who live affluent lives,
  well-attended by medical care and treatment,
  should not ask how Germans or white South
  Africans could tolerate living in proximity to
  moral evil. We do so ourselves today, in
  proximity to the impending illness and death of
  many millions of people with AIDS. This will
  happen, unless we change the present government
  ineptitude and corporate blocking. Available
  treatments are denied to those who need them for
  the sake of aggregating corporate wealth for
  shareholders who by African standards are already
  unimaginably affluent. That cannot be right, and
  it cannot be allowed to happen. No more than
  Germans in the Nazi era, nor more than white
  South Africans during apartheid, can we at this
  Conference say that we bear no responsibility for
  30 million people in resource-poor countries who
  face death from AIDS unless medical care and
  treatment is made accessible to them.
• Mr Justice Edwin Cameron, High Court of South
  Africa,
• First Jonathan Mann Memorial Lecture, 13th World
  AIDS Conference, Durban, South Africa, 2000

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The Shifting Consensus

• Access to AIDS treatment for those who
  seroconvert in HIV prevention trials was not even
  on the agenda ten years ago
• Broad agreement now exists among sponsors of HIV
  prevention trials that antiretroviral therapy
  (ART) and a clinical care package should be
  provided to those who become infected during the
  conduct of a trial, certain practical issues
  remain unresolved, including who should pay for
  ART? How long should ART be provided for? Does
  treatment extend outside of ART? What else should
  be included in the standard of care package and
  who should pay for it? Who should provide
  treatment and care? (Treating people with
  intercurrent infection in HIV prevention trials.
  Report from a WHO/UNAIDS consultation, Geneva
  17-18th July 2003)

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The Consequences of Delay

• The recent controversy around the TDF studies in
  Cambodia, Cameroon, Thailand partially have been
  driven by communities concerns about access to
  ART for seroconverters and those who screen out
  of studies.

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Who is Responsible?

• We all are.
• No one gets off the hook.
• Nobody.
• The task is too complex for any stakeholder to
  opt-out.

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Who is Responsible?

• Please no more statements such as
• I am just a researcher and dont want to get
  involved in politics
• I can only tell you what my agency can do under
  current regulations
• If the funders want to do it, it is a simple
  task
• We are already doing it.

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Two Levels of Responsibility

• At the international level, funding agencies
  (e.g. NIH, Gates, ANRS, MRC, etc.), donor
  governments supporting treatment and care
  programs, international agencies (e.g. WHO,
  GFATM) need to quickly come together to figure
  out the mechanisms for supporting care to trial
  participants
• These discussions need to include researchers,
  national ministries of health, the AIDS community
  and other stakeholder groups.

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Two Levels of Responsibility

• At the local level, researchers need to work with
  local ministries of health, the AIDS community
  and other stakeholders to craft specific care and
  treatment plans for trial participants.
• These discussions need to be about individual
  studies, but also national frameworks for
  providing treatment across studies.

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What are We Waiting For?

• Providing treatment is going to be a complex
  undertaking
• Its going to take a collaborative effort among
  high-level leaders working with all stakeholders
• Its going to require a new approach-weve never
  done this before-so its going to require
  innovative thinking and political change.

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Todays Demand

• No more delays
• Convene the relevant partners now to discuss how
  to provide treatment in the context of trials
• No more theory, ethical guidelines-we must move
  on to implementation
• Let us begin to figure out the millions of tiny
  decisions that now have to be made to make this
  happen.