This paper presents an ethical analysis of the Therac-25 radiation therapy machine case, in which software malfunctions caused severe injury and death to cancer patients. The paper identifies the key stakeholders — including patients, hospitals, the FDA, AECL, operators, and the public — and examines their respective rights, duties, and vulnerabilities. Drawing on utilitarian frameworks from Bentham, Wenz, and Griffin, it evaluates the costs and benefits experienced by each party. The paper also explores alternative scenarios in which AECL might have addressed software defects earlier, assessing how such changes would have affected each stakeholder group and potentially prevented harm.
Patients — This category includes both the victims and the patients who were subject to treatment with Therac-25 but did not experience any side effects during therapy.
Victims' loved ones — Family and friends who lost their loved ones sooner than expected.
Hospitals — The facilities in which the Therac-25 machines were operated.
FDA (Food and Drug Administration) — The institution that allowed Therac-25 to be released on the market based on a pre-market equivalence ruling. This type of approval assumes that a machine is suited for release because it is equivalent to another product already on the market.
Operators — Individuals directly involved in the administration of radiation therapy.
AECL (Atomic Energy Canada Limited) — The company that designed and built Therac-25.
The public — The entire population that could potentially be subject to the same therapy.
Patients — Patients have the right to agree or disagree with the treatment or therapy prescribed to them. If patients had been given accurate information about Therac-25 and still chose to undergo this kind of therapy, they would have borne responsibility for any potential negative side effects. However, because hospitals were not aware of the negative side effects and were responsible for informing patients on this topic, patients can no longer be held responsible for decisions made in favor of the therapy.
Victims' loved ones — If these individuals held power of attorney over the patient's treatment, they carry the same rights and responsibilities as those described in the patients' category. If they did not hold such power, their rights and responsibilities are moral rather than legal. Their duty is to support the patient's decisions and to inform the patient of any therapy side effects the patient may not be aware of.
Hospitals — These entities have the responsibility to use approved machinery and to hire competent operators to handle it. They must also inform patients of all effects that may occur as a consequence of the prescribed therapy. Hospitals have the right to choose which machinery is best suited to perform certain tasks, such as radiation therapy, and to select the most cost-efficient method for those tasks. One advantage of Therac-25 was that it was less time-consuming than other methods, leaving doctors more time to spend with their patients.
The treating physician falls within this category. He or she has the duty to prescribe and plan the treatment and to perform regular check-ups on the patient.
FDA — The institution is responsible for ensuring the safety of food and drug consumption. In this case, the FDA cannot be held fully responsible for releasing a machine that was not entirely safe. The safety rules in this industry stipulate that if a similar product has already received market approval, the FDA must issue a pre-market approval for the new product under review. In Therac-25's case, AECL used much of the software from two previously approved products — Therac-6 and Therac-20 — effectively compelling the FDA to approve Therac-25.
Operators — These individuals are responsible for the proper administration of radiation therapy. They are also obligated to inform hospitals of any anomalies they observe in the machine's functioning.
AECL — The company had the right to leverage the fact that its previous Therac products were based on similar software when applying for FDA approval. The company had the duty to release a product that was, to the best of its knowledge, safe, and to report to the FDA and operating hospitals any issues that could prevent the safe administration of therapy. AECL also had the responsibility to conduct a more thorough safety analysis and to account for the possibility of software malfunction in the final product.
The public — This group had the right to safety. Since accidents occurred and measures were not taken to prevent them from recurring, the public should have had a meaningful voice in the matter. The public could have pressured authorities to withdraw the product from the market until AECL produced patches to fix the errors.
As pointed out by Roberts and Reich (2002), public health regularly gives rise to serious ethical dilemmas. The FDA could have taken more precautions before approving Therac-25 — but would that have been fair to AECL, when all other companies were granted fast pre-approval for products using technology similar to already-approved devices? Equally, the FDA could have temporarily suspended the use of Therac-25 after the first incident — but would that have been fair to the remaining cancer patients who would have had to halt their therapy? One of the oldest utilitarian positions on healthcare dilemmas holds that decisions should be made according to potential consequences such that "the greatest happiness of the greatest number should be the final goal" (Bentham, 1996).
Nowadays, the utilitarian school of thought is divided into two groups: subjective utilitarians and objective utilitarians. The first group holds that wellbeing is defined in terms of each individual's personal experience (Wenz, 1986), whereas the second group argues that wellbeing should be measured through a composite index containing a set of "rationally knowable components of wellbeing" (Griffin, 1986). This distinction matters when evaluating who benefited and who was harmed by Therac-25's continued use.
In this case, most patients were being helped, while a small number were unintentionally harmed. Their loved ones were similarly affected — helped in some cases and harmed in others. The advantages of Therac-25 resided in its time efficiency, which allowed doctors to spend more time with their patients to determine the best course of treatment. The disadvantages were that, in rare instances, a software anomaly in the equipment caused severe harm. Some victims suffered severe skin burns; other cases were fatal. For these patients, the cost of undergoing treatment outweighed the benefit. For the remaining patients who experienced no side effects, the costs were lower than the benefits. On balance, for most patients the utility of using Therac-25 was high, and the overall utility across the patient population was also high.
"Explores counterfactual outcomes if AECL had acted differently"
"Cited academic and utilitarian ethics sources"
You’re 64% through this paper. Sign up to read the remaining 2 sections.
Sign Up Now — Instant Access Already a member? Log inAlways verify citation format against your institution’s current style guide requirements.