By Erik Sass, Editor-in-Chief
Sometimes the strange state of our reality can be summed up by two juxtaposed news items. Take this week’s bizarre exercise in cognitive dissonance: On the one hand, Rick Bright, the former director of the Biomedical Advanced Research and Development Authority, took a victory lap in front of Congress for saving Americans from hydroxychloroquine (HCQ), the anti-malaria drug repeatedly mentioned by President Trump as a possible treatment for COVID-19.
On the other hand, the World Health Organization published informal dosage guidelines for the drug, which is widely used to treat the disease by advanced healthcare systems around the world.
Even more confounding, on the very day Bright testified about the potential dangers of this medicine, the U.S. National Institutes of Health quietly announced a new clinical trial to evaluate a combination of HCQ and azithromycin in patients with mild to moderate COVID-19.
Yes, you read that right. While HCQ has become a cudgel for Democrats and the mainstream media to beat Trump, with news outlets brandishing a few low-quality studies as proof it doesn’t work, the drug is part of recommended treatment for COVID-19 in South Korea, France, Spain, and Italy, among many others. In March, WHO included HCQ in its global study of the most promising drugs against COVID-19.
The fact is the U.S. government’s decision to try HCQ along with other experimental treatments was – and continues to be – squarely in line with the international medical mainstream.
America is the only country where the Cold War-era anti-malarial is controversial – largely for reasons having nothing to do with its efficacy against COVID-19. It is an epic demonstrate of dissonance that this controversy persists even as our own national health authority is actively starting new trials to explore its therapeutic effect in patients with COVID-19.
HCQ’s risks and side effects are well known, including the danger of heart arrhythmia. But America’s federal public health regulators stand alone among their international peers in discouraging doctors from using HCQ on grounds of safety.
In fact HCQ is already prescribed for a wide range of conditions, including lupus and rheumatoid arthritis, on an out-patient basis – something anathema to America’s federal health officials when it comes to COVID-19.
Before the current controversy, HCQ was widely regarded as a safe drug – including for pregnant women and children. Yet following Trump’s first mention, newfound safety concerns about QT prolongation in a minority of patients managed to outweigh the potential benefit of the drug in treating COVID-19 in the eyes of federal regulators, even at a time when no other treatments were available.
Notably, this key decision was issued without public insight into the process.
Despite Bright’s calls for transparency, their assessment of the risk and benefit from HCQ seem to have been made in closed-door, bureaucratic fashion:
“My concerns around the safety of hydroxychloroquine in people infected with the COVID-19 virus were reflective of the scientific review that we received from an inner agency group of clinicians and regulatory experts and scientists.”
How could these experts come to a conclusion so at odds with global medical practice? The mystery deepens in light of the WHO informal consultation on dosage for its global clinical study of HCQ, published on May 8. The informal consultation, an ad hoc meeting of some of the world’s leading experts on virology and medicine, notes that a number of prophylactic studies are underway as well, meaning the drug is indeed being prescribed on an out-patient basis to individuals at risk of exposure.
Again, this is in glaring contradiction to the official American guidance on HCQ, which states that the drug is unsafe to use outside of a hospital setting. In fact Bright claims that he was moved to open opposition by the fact that it might be prescribed on an outpatient basis:
“I was directed, as the BARDA director, from the office of the HHS secretary, to put in place an expanded access I and D program to make chloroquine donation from Bayer available to Americans through a unique opportunity that would utilize an app and perhaps even make it available to Americans who were not under close supervision of a healthcare provider [i.e. hospitalized].”
The disconnect between Bright’s stance and prior medical practice in this country, as well as current medical practice abroad, is remarkable. 1.5 million Americans with lupus and 1.3 million Americans with rheumatoid arthritis have been taking HCQ safely on an out-patient basis for decades.
Meanwhile, foreign doctors are treating patients with COVID-19 with HCQ at home, reportedly with good effect.
No one should ask or expect American doctors to slavishly copy their foreign counterparts. And yes, the world is still waiting for the results of randomized clinical trials to determine HCQ’s true degree of efficacy against COVID-19. But the simple fact that so many world-class medical systems have allowed or recommended HCQ, including for out-patient treatment, is surely food for thought. Among other issues, it raises the question of how and why a scientific question has become politicized in the U.S., and whether this partisan game of “gotcha” based on incomplete research is really in the best interests of American patients facing COVID-19.
In his testimony, Bright averred:
“First and foremost, we need to be truthful with the American people. Americans deserve the truth.”
We couldn’t agree more.
Erik Sass is Editor-in-Chief of The Economic Standard and author of popular history books.