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Why High Drug Pricing Is A Problem for Research Ethics.
1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. shey@bwh.harvard.edu.
Journal of Bioethical Inquiry
|December 21, 2019
Summary
High drug prices raise ethical concerns for research participants. Ignoring future drug costs during clinical trials violates core research ethics principles, impacting participant respect, risk/benefit assessments, and justice.
Area of Science:
- Bioethics
- Pharmaceutical Policy
- Clinical Trial Ethics
Background:
- The high cost of pharmaceuticals is a significant concern for policymakers and ethicists.
- Current discussions primarily focus on the gap between drug development costs and company profits, and potential price regulations.
- Ethical considerations for clinical trial participants regarding future drug pricing remain largely unaddressed.
Purpose of the Study:
- To examine the ethical implications of high drug prices for research subjects.
- To argue that ignoring future drug pricing during clinical trial ethical reviews conflicts with established research ethics principles.
Main Methods:
- Ethical analysis of clinical trial review processes.
- Examination of the three core principles of research ethics: respect for persons, beneficence (risk/benefit analysis), and justice.
- Literature review on pharmaceutical pricing and research ethics.
Main Results:
- Ignoring future drug prices during ethical evaluations of clinical trials disrespects research participants.
- This oversight compromises the ability of ethical review committees to accurately assess risks and benefits.
- It also hinders the evaluation of future patient access and the principle of justice.
Conclusions:
- The ethical evaluation of clinical trials must incorporate considerations of future drug pricing.
- Addressing drug pricing ethics is crucial for upholding respect for participants, ensuring sound risk/benefit analyses, and promoting justice in healthcare.
- A more comprehensive ethical framework is needed for drug development that includes the societal impact of pricing.
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