After over a year of TrialSite reporting on the need for early-onset, antiviral-like care for COVID-19, now the U.S. government will launch a mini “moonshot” targeting antivirals necessary not only for viruses such as SARS-CoV-2 but for the inevitable new ones that will surface in the future. Powered by the same players—that is, the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) as well as the Biomedical Advanced Research and Development Authority (BARDA)—under the current Executive Branch administration, a new program under Dr. Anthony Fauci’s NIAID called the “Antiviral Program for Pandemics” will target the 90% of cases involving either asymptomatic to mild-to-moderate SARS-CoV-2 infection. But now with a focus on “sustainable platforms” to discover and develop antivirals, perhaps one of the key players in what’s been a total failure on the part of the federal research apparatus to address affordable repurposed antivirals (other than ensure Gilead could secure billions starting last May), Dr. Anthony Fauci was still able to get his customary quote, emphasizing, “New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives.”
Marketing or the Real Thing?
TrialSite makes the case below that the time to act to save lives with antivirals, especially cost-effective ones, addressing the pandemic was last summer at the latest. The federal money train spent probably north of $20 billion not only to help accelerate vaccines but also several novel experimental therapies with little pragmatic utility during a pandemic where 90% of the cases are asymptomatic to early-onset mild-to-moderate infections, necessitating care over advanced experimentation.
This platform supported the experimentation but implored that the NIH move aggressively with dozens of identified repurposed drugs to consider for treating COVID-19 early on. More on that below. But what the federal bureaucracy has done now is created yet another program where more than likely over-paid bureaucrats will be able to take credit for first and foremost handing lots of money over to biotech and pharmaceutical companies. In this post-free market, crony capitalistic world, one where regulatory capture is the norm, not the exception, this is exactly what happens as the same old cast of characters behind the last efforts are at it all over again.
They will “evaluate, prioritize and advance antiviral candidates to Phase 2” while benefitting from the present day and “expanded contract resources” of the NIH as well as the infrastructure provided by the National Center for Advancing Translational Sciences (NCATS) to “de-risk” those early pipeline candidates. They’ll spend over $300 million for research and lab support and toss in almost $1 billion for preclinical and clinical evaluation plus nearly $700 million for development and manufacturing via NIAID and BARDA.
Moreover, the feds will now spend up to $1.2 billion to create and support a new group called the Antiviral Drug Discovery (AViDD) Centers for Pathogens and Pandemic Concern that seeks to “harness the creativity of the biomedical research community and drive innovative antiviral drug discovery and development.” Seeking to develop “platforms,” the initial target is SARS-Cov-2, although as TrialSite has and will argue, they’re about a year or more late in the game, and unfortunately, the lives lost can’t be changed. In this case, they plan on allocating $200 million to the contractor while undoubtedly the rest will more than likely go to bureaucratic overhead.
Undoubtedly, the intentions of many involved are good and perhaps the federal bureaucracy, implicitly at least, understands its failures concerning cost-effective antiviral and early onset care and hopes for a better response during the next pandemic or comparable threat?
Antiviral-Like, Early-Onset Care: A Dramatic Failure
It was last summer when TrialSite frantically published on a consistent basis the need for early-onset treatment for COVID-19. Too many doctors from too many places and walks of life were declaring the same thing. There needs to be early onset treatment yet the federal bureaucracy ignored this, along with the media. Other countries that had less taxpayer funds to burn got it. It was ironically in many low-to middle-income countries (LMICs) that picked up on drugs such as ivermectin frankly out of economic necessity.
TrialSite sent a communication imploring NIH Director Dr. Francis Collins to include antiviral-like drugs such as ivermectin in the ACTIV program (Accelerating COVID-19 Therapeutic Interventions and Vaccines) as it was painfully apparent just how biased its backer, the Foundation for the National Institutes of Health, had become based on the allocation of many billions of dollars in not just vaccines but also novel, experimental monoclonal antibodies that had little practical use for the vast majority of COVID-19 cases. That is, either the asymptomatic to mild-to-moderate early-onset SARS-CoV-2 infection representing about 90% of the total cases. Not too long ago, ACTIV-6 actually included ivermectin but it was already far too late in the pandemic’s course.
ACTIV was set up to drive federally-sponsored research but, as TrialSite discussed, the actual makeup of the group’s leadership lacked any representation from the pragmatic clinic, where care occurs. Moreover, in “NIH’s Therapeutic Management of Patients with COVID-19 Some Unanswered Questions about Disturbing Chasm,” TrialSite noted the distinct government bias in favor of high-priced, novel therapeutics over low-cost, repurposed generics such as ivermectin, fluvoxamine, and several other notable candidates. The billions in spend speaks for itself.
The First Year of the Pandemic, Repurposed Candidates Available in Plain Site
TrialSite’s an innovative place where academic researchers, pharmaceutical executives, clinical investigators, community physicians, nurses, government regulators, public health officials, and the general public come together to find a less biased and more transparent version of the unfolding world of biomedical research.
It’s here that the need for early-onset antiviral therapeutics had first been consistently and continually called out for. In many cases, TrialSite authors and contributors reminded the federal agency viewers, those from the NIH, CDC, FDA, and more about the various targets identified and tested ongoing. Ivermectin’s now at 60 clinical trials and ACTIV finally came around to including that promising drug that’s already been authorized for the COVID-19 indication in several countries. TrialSite was there to tell the world that ivermectin absolutely zaps SARS-CoV-2 in the lab down in Australia. TrialSite then systematically chronicled one ivermectin study after another, the overwhelming majority of which showed positive results while government and industry, and of course mainstream media looked the other way.
But there were so many options brought to the forefront. As early as May 2020, a collaborative out of the University of California San Francisco (UCSF) Quantitative Biosciences Institute (QBI) had already uncovered a number of potential drugs to target SARS-CoV-2 as described in “UCSF Collaborators Identify Existing Drugs that Show more Potential Against SARS-CoV-2.” Then on June 26, 2020, TrialSite indicated in “Scripps & Calibr Select AI-based Drug Discovery Platform to identify Repurposed Drugs Targeting COVID-19,” which turned up a number of promising candidates.
And on July 26, 2020, TrialSite shared that Sanford Burnham Prebys found 21 possible candidates that acted against COVID-19 in the lab. Add many dozens more over a year later and now the federal bureaucracy cares?
A Good NCATS Leader Quits His Post
Then fast forward to April 2021 when TrialSite reported, “Is the Departure of NCATS Director Indicative of NIH Repurposing Track Record during the Pandemic,” articulating that the embrace of ivermectin by the ACTIV program was a year too late. Far too many people had already passed away and all of those that could have inhibited that disease progression could have been saved. That’s probably why the well-respected NCATS Director Christopher P. Austin, a known advocate for repurposing drug research, formally called it a day from his prominent post. Behind his departure was the dismal failure of the nation’s apex research agency’s ability to act in a pandemic to help save lives. Yes, vaccines were cranked out under Operation Warp Speed but this was as much the result of the much-despised former POTUS who actually doesn’t get the credit he probably deserves for lighting a fire under the research apparatus’ collective rear end.
Now New POTUS Sees the Light
The federal apparatus collectively knows its guilty of the failure to act and must now scramble to make up for lost ground, although it can never bring back the lives of the hundreds of thousands of people it could have saved, had it been operating with patients in mind rather than a fixation on power, money, and political maneuvering as its central organizing theme.
But now thanks to the visionary prowess of the current White House regime, another $3.2 billion will be pumped into developing antiviral pills to treat SARS-CoV-2 infections. Perhaps even some of those pills might be ready by the end of the year if all goes according to plan. Undoubtedly, they are referring to the $1.2 billion in subsidy they already contractually committed to Merck.
Now about $18 billion or so of that went into vaccines and several billions in the aggregate to monoclonal antibodies from the likes of Regeneron, Lilly, AstraZeneca, and others that one hears very little in the press about as of late. Perhaps that’s because the money already has changed hands. More than likely the same will happen with the $3.2 billion under the present POTUS but we’ll hope for the best and track the spend and the outcomes regardless.
Any Indication of Current Spend Preferences?
Well, how about $1.2 billion, for a start, to secure doses from Merck for a limited drug that has a litany of challenges as discussed recently in “Merck’s Incredible Quest for the COVID-19 Blockbuster: A Tainted Path to Early Onset Mild to Moderate COVID-19 Therapy.” Why does Merck need a taxpayer-based secured commitment? They already received $356 million of taxpayer money just in December for the development of a potential COVID-19 vaccine. Perhaps its because they are “at risk” in making the stuff. You bet they are at risk because more than likely a sizeable market for the drug will never materialize in the first place. Hence why the once-great American pharmaceutical company wants a subsidy if they can progress the drug to EUA or approval.
Rest assured, TrialSite will track the spend on NIAID’s Antiviral Program for Pandemics carefully.