Physicians have a moral obligation to protect their patients, not only from physical harms but also the financial harms that come with costly drugs that provide little therapeutic benefit, according to an article published in the AMA Journal of Ethics.
Investigators Leonard M. Fleck, PhD, professor of philosophy and medical ethics at the Center for Ethics and Humanities in the Life Sciences, at Michigan State University in East Lansing, and Marion Danis, MD, head of the Section on Ethics and Health Policy at the National Institutes of Health (NIH) in Bethesda, Maryland, and chief of the ethics consultation service at the NIH Clinical Center, presented a case study of a physician who is part of his tertiary care center’s accountable care organization (ACO) that is considering whether or not to add a new biologic to the center’s formulary to illustrate the difficulties faced by physicians making therapeutic decisions in real-life situations.
The researchers noted the explosion in monoclonal antibodies, particularly in the field of oncology, which are high-cost and some which make doubtful contributions to life expectancy and quality of life. For the 71 cancer drugs approved by the US Food and Drug Administration (FDA) between 2002 and 2014, the median gains in progression-free and overall survival were only 2.5 months and 2.1 months, respectively, while the annual cost of these drugs was $100,000 or more.
Physicians are under pressure to serve both as advocates for their patients and as “prudent stewards” of healthcare resources. Balancing these concerns in an ethical manner demands careful consideration of both benefits and costs. The investigators suggested minimal concern for agents that provide significant gain in overall survival with tolerable side effects. They also suggested removing cost barriers, including high copays and deductibles, for therapies that are effective for diseases such as cancer. Furthermore, they advocated holding pharmaceutical companies responsible for price gouging.
The researchers concluded by noting that physicians must spend time with patients to help them make informed decisions regarding the value of therapy from both an individual and a social perspective.
Fleck LM, Danis M. How should therapeutic decisions about expensive drugs be made in imperfect environments? AMA J Ethics. 2017;19:(2)147-156.