The Annals of Internal Medicine’s May 7 article, “Biomedical Research in Times of Emergency: Lessons From History,” offers valuable insights for this time of pandemic. COVID-19 has now killed hundreds of thousands of people and “utterly disrupted the daily lives of billions of people around the world.” Now, billions of dollars are being allocated to trials aimed at understanding and stopping the virus. Comparing our efforts to “the Manhattan Project, penicillin, and the polio vaccines in the 20th century, they also noted that pressurized research led to “false promises, disastrous consequences, and breaches in ethics.” Examples include contaminated vaccines in World War II and unethical mustard-gas experimentation. It is also emphasized that early research results must be viewed “with caution as we only begin to understand the biology, epidemiology, and potential target points of COVID-19.”
Current Trials Fast-Tracked, Caution Necessary
As of May 2, ClinicalTrials.gov indexed 681 interventional trials and 437 observational studies. NIH has offered billions in newly-apportioned grant funds. Journals are rushing to share data. Other factors include preprint websites like medRxiv for rapid information dissemination. So, the conclusions presented are not peer-reviewed, “and caution should be taken before changing clinical practice or public policy on the basis of these findings.” Another point is that until randomized controlled trials are available, the reluctance to withhold treatment in control-arms leads to single-arm/observational reports. Another factor is disruption in research. Most labs have halted all but critical activities. Novel-agent trials are temporarily suspended, while there is a boom in COVID-19 research. The article reminds us of some of the pitfalls of emergencies, “urgency may also result in compromised research quality and ethics, which may in turn jeopardize public faith in government and science, waste precious resources, and lead to the loss of human life.”
One problem noted is that since suddenly most/many scientists are working on this one disease, lots of them are out of their area of expertise.
Learning From History: World War II to Swine Flu
Prior reactions to emergencies have galvanized public-directed research, such as the billions of dollars and thousands of scientists which led to the nuclear bomb. Per the Annals, “During World War II, scientists were desperate to mass-produce yellow fever vaccines to protect millions of service members crisscrossing the globe to areas rife with the disease. Relying on untested human serum, they unknowingly used a contaminated sample to formulate the vaccines and infected tens of thousands of GIs with hepatitis.”
Next drug, World War II research “with little in the way of implied consent” with mustard gas was performed on “prisoners and conscientious objectors.” The urgency of war led to what were clear lapses, even under then-existing medical ethics. Also, in 1976, the US rushed swine flu vaccination, in the end likely causing 500 cases of Gullian- Barré, “while the flu proved inconsequential, discrediting the entire program and eroding public faith in U.S. government and medicine.”
Concluding, the take-home message is that while our methods and ethics have improved much since the 1918 flu, the problems inherent to research conducted under emergency conditions should not be forgotten.Source: