ABSTRACT
Do pharmaceutical companies have a moral obligation to expand access to investigational drugs to patients outside the clinical trial? One reason for thinking they do not is that expanded access programs might negatively affect the clinical trial process. This potential impact creates dilemmas for practitioners who nevertheless acknowledge some moral reason for expanding access. Bioethicists have explained these reasons in terms of beneficence, compassion, or a principle of rescue, but their arguments have been limited to questions of moral permissibility, leaving for future research the question of whether expanded access is morally obligatory. We take up this further question and argue that pharmaceutical companies have a moral obligation to expand access. Our defense is not based on beneficence, compassion, or rescue, but instead on a reciprocal moral expectation resulting from existing social commitments that help ensure a robust pharmaceutical practice within the broader healthcare system. Our aim is to give this obligation, along with several others, a coherent and plausible structure within the wider clinical trial process so that one might better explain the sources of the dilemmas and their possible resolutions.
Subject(s)
Biopharmaceutics/ethics , Drug Industry/ethics , Drugs, Investigational/therapeutic use , Health Services Accessibility/ethics , Moral Obligations , Beneficence , Bioethical Issues , Clinical Trials as Topic/ethics , Drugs, Investigational/administration & dosage , Drugs, Investigational/adverse effects , Humans , Social JusticeABSTRACT
BACKGROUND: Biopharmaceutical studies for anti-cancer drugs are typically conducted in cancer patients due to unacceptable toxicities to healthy volunteers. Navitoclax is a first-in-class, orally bioavailable, targeted Bcl-2 family protein inhibitor that has been studied in cancer patients. METHODS: A strategy that integrated the evaluation of non-clinical toxicology data and clinical data in cancer patients was employed to assess the feasibility, determine doses and establish risk management plans for studying navitoclax in healthy volunteers. Two relative bioavailability/food effect studies with either a 25 mg dose or 50 and 100 mg doses of navitoclax were conducted sequentially in healthy female volunteers of non-childbearing potential. RESULTS/CONCLUSION: Navitoclax was well-tolerated in both studies in healthy volunteers, and did not impose risks beyond the minimal levels expected in healthy volunteer studies. Compared to a similar study in cancer patients, the studies in healthy volunteers generated higher quality data in a short period of time to support formulation selection.
Subject(s)
Aniline Compounds/administration & dosage , Aniline Compounds/adverse effects , Biopharmaceutics/ethics , Sulfonamides/administration & dosage , Sulfonamides/adverse effects , Administration, Oral , Adult , Aniline Compounds/pharmacokinetics , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Antineoplastic Agents/pharmacokinetics , Biological Availability , Biopharmaceutics/methods , Cohort Studies , Cross-Over Studies , Female , Food-Drug Interactions , Humans , Male , Neoplasms/drug therapy , Neoplasms/metabolism , Risk Assessment , Sulfonamides/pharmacokineticsABSTRACT
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