On October 29, 2021, 2,025 Americans died from COVID-19.
Although the worst times of the pandemic seem to be over, still too many people are dying and many more linger in ICUs on ventilators, on their way to a lonely death by suffocation. Today, the FDA advises there is limited availability of ventilators, and there are US cities that have run out of morgue space. Tragically, half of these lives, perhaps even more could be saved by investigational drugs currently before the FDA, were those drugs to be granted Emergency Use Authorization (EUA). Congress enacted the EUA law specifically so that FDA would immediately deploy drugs that are safe and “may be effective” in the face of a public health emergency. The COVID-19 public health emergency was declared by the Secretary of Health and Human Service in March 2020 and has been unrelenting since that time.
The concept of EUA has been proven to be highly efficient and successful with the development of vaccine compounds, where in record time several vaccine candidates have been developed, tested, authorized, and eventually distributed across the globe to fight the pandemic through mass-immunization. The question remains to me, why this powerful tool has not been applied to the same extent with highly promising therapeutic cure candidates? National Institutes of Health (NIH) Director Dr. Francis Collins confirmed in a public forum that three such drugs from small, innovative biotech companies, Leronlizumab, Lenzilumab, and Aviptadil are among the few viable candidates for treating COVID-19 of the more than 750 compounds screened by the National Institutes of Health. Yet, inexplicably, despite clear early evidence of efficacy Leronlizumab and Lenzilumab have been denied EUA and Aviptadil has been awaiting an EUA decision already for 150 days.
For the FDA to deny EUA to drugs that show any reasonable promise of saving life is highly questionable in a time of widespread loss of life. The FDA has a legal and moral obligation to weigh benefits and risks according to society’s tolerance for such risks. However, the refusal to grant EUA to these innovative drugs from small companies is wholly out of sync with FDA’s grant of EUA to minimally effective drugs from Big Pharma. Remdesivir has been deemed ineffective for all but the earliest COVID cases by the World Health Organization and other regulators, yet it was approved by the FDA. Tocilizumab has shown only a four percentage point mortality benefit at best. Yet, highly innovative drugs with no reported Serious Adverse Events, that have shown 2, 3, and even 4-fold advantages in survival languish at the FDA with endless demands for more data.
A petition was launched on change.org to demand the FDA grant EUA to Aviptadil and it has received nearly 5,000 signatures: https://chng.it/4jRjfq6MYV People worldwide are threatened by an enemy far more dangerous than any faced on the battlefield while the world looks to the US and the FDA for leadership thru this crisis. More Americans have been killed by COVID than by all of America’s foreign wars.
Every American should be writing their elected representatives and demanding that FDA make available all emergency use medicines that have shown a statistically-significant 50% or greater survival benefit in at least one clinical trial. Congress should threaten to bypass the FDA and legislatively approve EUA for drugs that demonstrate a 100% or greater survival benefit, such as Aviptadil, which it has, according to a medical paper published in the Journal of Infectitious Diseases and Treatment led by Dr. J. Georges Youseff. The question must be answered by the FDA as to why it is simply unwilling to act in a manner that saves the lives of Americans? As every pharmaceutical TV commercial advertising cures for common diseases reminds us, many of these drugs come with serious safety risks and side effects; but we choose to take these drugs to improve our quality of life. I imagine few Americans would turn down the chance to live, even if the drug in question might show some unknown safety risk when used more broadly.
Until February this year, I was a member of the Board of Directors of Swiss based Relief Therapeutics SA (symbol: RLFTF and RLF.SW) which owns the IP for the formulation of Aviptadil. For disclosure purposes I remain an insignificant shareholder of Relief. Relief has been collaborating on the development of Aviptadil with NRX Pharmaceuticals, Inc. (symbol: NRXP), a company which I have no affiliation. NRX Pharmaceuticals has been mandated to manage the submission to the FDA and the ensuing review process. I am writing this article to bring awareness to the availability of a drug which can save lives and to make elected officials as well as patients and their relatives aware of a potential solution for the most serious of Covid cases.