Hype over dexamethasone as Covid-19 cure might prove to be costly and break people's trust in science: Expert
Recently, researchers working on the UK-based 'RECOVERY' trial announced that dexamethasone — a cheap and widely available drug — that lowers inflammation may save the sickest Covid-19 patients. Patients on ventilators who were given the steroid were 35% less likely to die compared to other patients on ventilators who were not given it.
The findings look promising given the positive results. But it reportedly comes with a red flag since the researchers have only released a summary of the data. They have not released a complete, peer-reviewed paper, though they have reportedly said the complete research paper will be published soon.
Commenting on the news, Mark T Heise, Ph.D., Professor of Genetics, Microbiology, and Immunology at the University of North Carolina, Chapel Hill, said that these findings should be interpreted with caution because in the past multiple “not-so-perfect” studies have cropped up but later they were withdrawn after showing negative results. A very recent instance was the retraction of high-profile studies on potential Covid-19 treatments, hydroxychloroquine and chloroquine, due to suspect data.
A small French study in March claimed that hydroxychloroquine, the anti-malarial drug, has the potential to treat coronavirus. However, as more robust studies came out, they suggested that the drug was at best ineffective, and at worst potentially harmful. Same happened with chloroquine that led FDA to revoke "the emergency use authorization (EUA) to use hydroxychloroquine and chloroquine to treat Covid-19 in certain hospitalized patients when a clinical trial is unavailable or participation is not feasible."
According to a site called 'Briz Brain & Spine', dexamethasone also has side-effects if not taken under guidance. The site lists the side-effects of the drug when its use is prolonged. "It commonly causes weight gain, high blood sugar (making diabetes worse), muscle weakness, mood and behavioral changes, sleep disturbance, suppression of the immune system, etc — the list goes on. So the use of dexamethasone should be limited to try to reduce or avoid some of these unpleasant side effects."
“If studies are rushed to the point that experiments are not repeated or careful controls are not included, this can lead to erroneous findings. In the worst case, this might lead to unsafe or ineffective treatments/vaccines being promoted, as exemplified by chloroquine. These none-so-perfect studies also hold the risk that if their results prove not to be reproducible, or even invalid, this can further undercut public confidence in science,” Heise told MEA WorldWide (MEAWW), adding: "The best ways to address this remain rigorous peer review, which will hold the work to high standards, and transparency in the reporting of methodologies and results so that others can attempt to reproduce results as quickly and accurately as possible to determine whether the findings are valid."
The professor also explained how the pandemic has put pressure on researchers to accelerate the traditional slow-and-steady scientific review process in the time of the pandemic, which has claimed over 400,000 lives globally. “I think that the entire scientific community feels intense pressure to push Covid-related results out at quickly as possible. In our case, we are working longer hours (there are no weekends anymore) and moving people from other projects to accelerate drug and vaccine testing studies, while still adhering to our normal standards of ensuring that results are reproducible and well-controlled. In many cases, we are trying to accelerate the reporting of results by publishing the work in smaller units.”
Heise added: “In a hypothetical example, pre-Covid, if we identified a drug that inhibited the virus, we might have waited to publish the paper until we had a full understanding of the drug’s mechanism of action, which can add months or even years to the study. Now, in order to ensure that the information gets out to the scientific and medical community as quickly as possible, we would focus on making sure that the initial results were reproducible and well-controlled, and then report those results (e.g. drug A inhibits SARS2 in cell culture and animal models) as fast as possible. We would then report the mechanistic analysis in follow-up manuscripts.”
Heise also warned that the general public “should hold off on putting too much credence into results until they have been reproduced by multiple groups/studies. Likewise, public officials, the media, and scientists should hold off on promoting (hyping) results until they have been shown to be reproducible, or at the very least, undergone peer review.”
At the end of the interview, Heise told MEAWW that if dexamethasone is proved to treat Covid-19 “and if the results stand up and are shown to be reproducible in larger populations of patients, I expect that it would be incorporated into the standard of care for individuals with severe SARS2-induced disease.”