Which ethical concern arises with compassionate use?

• A. Lack of Patient Protections
• B. Overuse of Therapies
• C. Inadequate Informed Consent
• D. Exploitation of Vulnerable Patients

Answer: (D)

Compassionate use is about giving access to investigational therapies for patients with serious or life-threatening conditions who have no good alternatives. The strongest ethical concern in that context is the exploitation of vulnerable patients. When someone is seriously ill and options are limited, they may feel desperate for any chance at benefit, which can make them more susceptible to coercion, pressure, or manipulation by doctors, sponsors, or even marketing incentives. This vulnerability can compromise true voluntary consent and tilt decisions toward hoping for a miracle rather than a balanced assessment of risks, benefits, and uncertainties.

To safeguard autonomy, it's essential to ensure robust informed consent, independent review, and safeguards against undue influence, while also making sure access is fair and not driven by marketing or data collection at the expense of patient welfare. While gaps in protections or consent can contribute to risk, the fundamental ethical issue in compassionate use is protecting patients who may be exploited because of their vulnerability.