A Lancaster Cardiff collaboration

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A Lancaster Cardiff collaboration
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Priorities in pharmacogenomics

• Ruth Chadwick
• Lancaster

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Outline

• Priority of pharmacogenomics
• Priorities in pharmacogenomics
• Principles
• Patient groups
• Products
• Prerequisites

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Pharmacogenetics

• The study of individual differences at the
  genetic level (genes and SNPs) influencing
  response to drugs

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Pharmacogenomics

• The application of whole genome research,
  enabling associations to be made between specific
  drugs and genetic factors

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Priority of pharmacogenomics

• From medicalisation to geneticisation to pgx
• Only connect.
• Nutrition and nutrigenomics

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Renaissance?

• The Renaissance period of world history is
  analogous to the renewal of healthcare that will
  arise from pharmacogenomic discoveries
• (Brock et al)

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Department of Health

• There will then be the option to test people
• for a predisposition to disease, or a higher
  than normal risk. Treatment, lifestyle advice
  and monitoring aimed at disease prevention could
  then be tailored appropriately to suit each
  individual

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Safety and efficacy

• Functional foods
• Undermining the boundary between foods and drugs

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Priorities in pharmacogenomicsPrinciplesPatien
ts and populationsProductsPrerequisites
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(1) Principles

• Safety and efficacy avoiding harm and promoting
  benefit
• The negative-positive distinction
• Equity
• Individual and community

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Genetic exceptionalism

• Weight of argument against the thesis
• Pharmacogenetic exceptionalism

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Equity

• Pharmacogenomics has the potential either to
  increase or decrease health inequalities
• Loss of access to existing drugs
• Absence of therapy orphan patients

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The negative-positivedistinction

• Greater moral urgency of suffering
• Above all, do no harm
• But what about the failure to prevent harm?

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Individual and collective

• The more the promises are individualised, the
  more collective action is required

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Individualism?

• Informed consent
• Association studies and databases
• Individual and collective identity

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Principles of priority-setting

• Priorities for whom?
• Diseases of globalisation
• Economic criteria
• Criteria of fairness

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(2) Patient groups

• Children
• Draft regulation of the European Parliament and
  the Council of the European Union on medicinal
  products for pediatric use

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Draft regulation

• It is essential to ensure that pharmaco-vigilance
  mechanisms are adopted, in specific cases, to
  meet the challenges of collecting robust safety
  data in children, including data on possible
  long-term effects

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Implications for children

• Genetic testing?
• Genetic profiling at birth?
• Medication for life?

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(3) Products

• New medicines
• Me-toos
• Existing medicines

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Existing medicines

• Once medicines are no longer protected by
  patents, little financial incentive to refine
  their use, especially if this refinement means
  that fewer patients are advised to take the
  medicine (Nuffield Council on Bioethics)

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Generics

• Manufacturers of generic medicines have limited
  funds for investing in R D (Nuffield Council
  on Bioethics)

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(4) Prerequisites

• Public acceptability
• Quality control

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Quality control

• External quality assessment schemes (EQAs) of
  genetic tests in Europe have demonstrated a low
  but significant error rate in cystic fibrosis
  testing
• Implications of vast increase in volume of tests

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Quality control

• Model for quality control activities at early
  gene mapping workshops, where each new putative
  linkage relationship was discussed by a panel of
  experts
• Validated genomic information in an open database
  (cf HUGO Statement 2002)

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Public and professional acceptability

• The greater the precision, the more reliance is
  placed on compliance
• Acceptability of what?
• Public engagement moves upstream

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A Lancaster Cardiff collaboration