The "Speed Science" Paradox: Balancing Rapid Research with Safety
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COVID-19 has dramatically altered various aspects of our lives, including work, education, travel, and social interactions. While some areas have experienced significant slowdowns, the field of scientific research is witnessing unprecedented acceleration. Research is being conducted, published, and disseminated at a remarkable pace.
The guiding principle has become: “Be fast!” But is this approach of “speed science” genuinely a beneficial strategy?
This article examines the implications of “speed science” in the urgent quest for treatments—from compassionate therapies to vaccines—and its influence on the dissemination of scientific findings.
Speed Science & the Race for a Cure
In an era where swift scientific advancement is crucial, the FDA has introduced the Coronavirus Treatment Acceleration Program, an emergency initiative aimed at expediting potential therapies to patients. The motto remains: “Be fast!”
Globally, scientists are engaged in an intense race to identify treatments and vaccines for COVID-19, with at least 288 therapies and 106 vaccines currently under investigation. Three primary strategies are being pursued:
- Adapting existing approved medications.
- Advancing experimental drugs through clinical trials.
- Developing entirely new drugs or vaccines.
Cure Available in a Short Time
The first two strategies can yield results relatively quickly. Given the “exceptional circumstances,” therapies lacking robust evidence for efficacy—against COVID-19, SARS, or MERS—are being administered on a compassionate-use basis in hopes of enhancing patient outcomes while clinical studies are ongoing.
Remdesivir emerged as a leading therapy against COVID-19, showing effectiveness against coronaviruses similar to SARS-CoV-2 in animal studies. However, its efficacy remains contentious, with conflicting results from various trials. Dr. Anthony Fauci praised it as a potential standard treatment based on positive outcomes in U.S. trials, while results from a Chinese study suggested it offered no significant clinical benefits.
In summary, extensive research is still necessary, and time is essential! Research is inherently time-consuming!
Chloroquine, an antimalarial drug, gained traction in the hunt for a cure, but its serious cardiac side effects raised concerns. In Brazil, a clinical trial involving chloroquine was halted after serious heart rhythm issues affected 25% of participants given the higher of two dosages.
Countries are also exploring the compassionate use of convalescent plasma therapy for critically ill COVID-19 patients. This method, which involves transferring antibodies from recovered individuals to current patients, dates back nearly a century and has shown some efficacy against other diseases. However, it carries risks, including potential infection from transfusions and immune responses.
Dr. Vivek Nangia remarked on plasma therapy: “Desperate times require innovative solutions. This [plasma therapy] is a measure worth considering when conventional methods fail.”
Despite these efforts, no definitive treatment for COVID-19 is currently available. Thus far, speed science has not succeeded in delivering a rapid solution.
Cure Available in the Long Run: Monoclonal Antibodies and Vaccines
With initial strategies falling short, hopes are now pinned on the development of new drugs or vaccines. Many researchers are optimistic that monoclonal antibodies could soon emerge as effective treatments for COVID-19.
A collaboration between Vanderbilt University and AstraZeneca aims to synthesize a targeted antibody that can neutralize SARS-CoV-2 by binding to its spike protein, which is crucial for entering human cells. Once identified, these neutralizing antibodies could be produced in large quantities, potentially offering treatment or prevention for COVID-19. Antibody research is progressing rapidly, with expectations that “in the next 5 years, antibodies will become the primary medical response in epidemics.” Among the 50 monoclonal antibodies in development, at least one is anticipated to be a viable treatment option soon.
Vaccines are recognized as the most effective preventive measure against infectious diseases, offering a more cost-effective solution than treatments while reducing morbidity and mortality. Various COVID-19 vaccine candidates are being explored, including DNA and RNA-based vaccines, non-replicating viral vectors, inactivated viruses, live attenuated viruses, and protein subunit vaccines, with RNA and DNA technologies appearing particularly promising.
Dr. Anthony S. Fauci estimates that a vaccine could be ready within 12 to 18 months, although traditional vaccine development can take over a decade, as seen in the lengthy timelines for Varicella and FluMist vaccines.
Given that 106 vaccines are under exploration, the chances of success increase. Dr. Peter Hotez stated, “To meet that 18-month target, you need to maximize the number of candidates in development.”
Researchers are also accelerating trial processes, often overlapping phases to expedite progress. Dr. Bryan Bell noted the need to accept greater risks due to the extraordinary circumstances. Akiko Iwasaki from Yale University emphasized that traditional timelines would not suffice, suggesting that without these adjustments, a COVID-19 vaccine could be delayed until 2036!
As COVID-19 continues to impact the globe, one must question whether the rapid pace of trials is a wise strategy. Have we forgotten the lessons from historical incidents like the Cutter Incident and the Thalidomide tragedy?
The Cutter Incident (1955) involved 120,000 doses of polio vaccine containing live poliovirus that passed safety tests, leading to a polio epidemic among vaccinated children. This resulted in significant morbidity and fatalities.
The thalidomide tragedy, which emerged in the late 1950s, is a stark reminder of the importance of drug safety. Thalidomide was prescribed to pregnant women, but its teratogenic effects resulted in severe birth defects, culminating in over 10,000 affected children. This incident prompted significant changes in drug testing protocols, underscoring the need for comprehensive safety evaluations.
Why We Should Be Cautious With COVID-19 Medical Research
As we consider modifying clinical trial designs to hasten vaccine development, experts and the FDA emphasize the need for caution. Dr. Jeff Livingston aptly cites George Santayana: “Those who do not remember the past are doomed to repeat it.”
Speed Science & Publishing of Scientific Papers
Under normal circumstances, scientific papers undergo a peer review process before publication, typically taking around 100 days. However, the urgency of the COVID-19 pandemic has led to an increase in “pre-prints,” where researchers share findings without peer review. About half of the scientific literature on COVID-19 consists of such pre-prints, with bioRxiv and medRxiv serving as major platforms.
While pre-prints facilitate rapid knowledge sharing and collaboration—such as the swift publication of the SARS-CoV-2 genome—they can also propagate misinformation due to a lack of rigorous validation. Notable retractions have occurred after flawed studies gained widespread attention, highlighting the risks associated with premature publication.
Tom Sheldon, a science communications expert, remarked, “The public will not benefit from early findings if they are flawed or hyped.”
So, we revisit the initial question: Is “speed science” always a beneficial approach? The answer remains complex. While the advantages of rapid research may outweigh risks in compassionate therapies and scientific communications, utmost caution is necessary in clinical trial designs. It is crucial to remember that genuine research requires time!