Ethical Issues Regarding Investigational Drugs for the Treatment and Prevention of Covid-19

Abstract

The challenging COVID-19 pandemic has witnessed the searches for treatment for a disease that had never been known before. Therefore, developing a treatment for the pandemic reflexively has gone beyond the usual methods due to limited time and the urge to benefit the patient. In cases where licensed drugs are insufficient, patients with serious and life-threatening diseases can have access to investigational drugs. These investigational drugs are used within programs such as Compassionate Use (CU) and Emergency Use Authorization (EUA) based on certain legal regulations. In terms of clinical and research ethics, it is a must to keep a balance between the necessity for the treatment to be tested for safety and effectiveness and the purpose of benefiting the patient. Such programs that are aimed at treatment are legitimate due to the concessions caused by the urgent need of treatment for a life-threatening disease in the crisis of a pandemic, however, ethical inquiries must be maintained and even increased in such challenging periods especially because of the need for rapid decision-making and information update. The ethical dilemmas that investigational drugs create have become more apparent, especially in this time of pandemic we are facing. The use of drugs within CU and EUA has ethical challenges. In our study, these challenges are discussed on the basis of beneficence, non-maleficence and justice, which are the basic principles of medical ethics. Regarding this basis, pharmaceutical industry, health authorities and physicians have a great responsibility.