In reaction to the speed and severity of the COVID-19 pandemic, the medical community has responded by sharing, collaborating, and advancing therapies from basic science to the bedside at a faster pace than ever before. From an ethics perspective, deploying treatments and sharing experience before meeting standards for evidence-based practice has both potential risks and benefits. These risks and benefits must be carefully balanced.
During times of crisis, innovations are necessary to develop and guide effective treatment strategies. We generally hear about these novel approaches early, as a result of small studies, case reports, or non-peer reviewed information dissemination. Most of these innovations have not been through the rigor of adequately powered trials, certainly not the gold standard of double-blind randomized controlled studies. Waiting for the gold standard limits our ability to provide the best possible medical care, as understood at the time. Sharing and implementing real time innovations can be appropriate and helpful both to bridge the gap until better evidence is available and to accelerate knowledge dissemination and the idea/hypothesis generating process.
While expert opinion is one of the lower forms of evidence, it is superior to uninformed practice. In many instances, unless and until we are convinced of the possibility of harm from these treatments, it is appropriate to implement them. For new therapies colloquially called “compassionate use,” the preferred terms are either “off-label” (drug or device that is Food and Drug Administration [FDA]-approved for one use but being considered for another) or “expanded access” (a drug or device that is not yet FDA-approved). In traditional expanded access, both the patient and the physician request a treatment, the manufacturer agrees, and consent is obtained.
Early sharing of information can reduce information and experience asymmetry between areas impacted sooner or more heavily by a global health emergency and those that are impacted later or more lightly. It can also promote rapid crowdsourcing, innovation, and insights about therapies to be confirmed or rejected on a timeline that keeps pace with an ever-evolving threat.
Risks of Harm
When faced with the option of an unproven intervention, there is a cognitive bias towards intervention. Crises such as COVID-19 may exacerbate cognitive biases and misinterpretation of data and studies.1 The historical medical maxim to “first, do no harm” reminds us that we do have the ability to cause harm and that we must judiciously balance the intertwined principles of beneficence and nonmaleficence—pairing good intentions with an objective assessment that benefits are likely to exceed harms.