found that remdesivir could shorten hospital stays for those infected with the virus. It was the first major clinical breakthrough in developing treatments for those COVID-19 hits the hardest. The world needs innovation, and innovation requires a policy environment and market conditions that nurture it. That’s what the United
States brings to the table. Thanks to our brilliant scientists and our nation’s free market economy, we are delivering relief from this pandemic faster than anyone could have imagined. The research ecosystem is motivated as never before. Countless lives are at stake – and probably a Nobel Prize or two.
VACCINE
vaccine developed for humans. Two other coronaviruses are deadly, but not very contagious, and cases are rare, so it was not deemed necessary to develop vaccines for them. Four others cause some colds, but these are rarely dangerous, so developing a vaccine (or antiviral drugs) is a waste of effort when pharmaceutical expertise could be directed to more needful projects. Now we have another coronavirus, SARS-CoV-2, which causes the disease we call COVID-19. When it first came to light, I told my students that a vaccine would be developed soon, hopefully by the end of the year. I suspected that small-molecule antiviral drugs to lessen the severity of the illness would be very difficult to find, and it has proven to be so. Why was I confident that we would be able to produce vaccines against COVID-19? It has to do with the mutation rate of the virus. HIV mutates so quickly that it’s almost impossible to raise a vaccine against it, although researchers are still trying. Epidemiologists and virologists must decide each year which strains of influenza viruses they want to raise vaccines against, and they do a good job predicting the season to come, but it can be hit-or-miss, because the mutation rate of flu bugs is so high. SARSCoV-2 mutates with some frequency, but fortunately its mutation rate is roughly a quarter that of influenza
viruses. I thought that COVID19 would be a good candidate for a vaccine. In early fall 2020, there were several vaccines in phase III trials worldwide. The Johnson and Johnson vaccine triggered too may contraindications (deleterious side effects) and was withdrawn. Two vaccines are being approved and implemented in the United States as of this writing, with others in development and testing. This is a signal accomplishment, and all responsible – from President Donald Trump and his Warp Speed program to all the researchers worldwide – should take a bow. These are mRNA-based vaccines, too, which is really slick. Never has a vaccine gone from pathogen discovery to vaccine approval in less than a year – it is unprecedented. The president removed a lot of regulations and accelerated the process of vaccine discovery. Necessity is the mother of invention, and the emergency of COVID-19 enabled us to figure out how to make fast vaccines with streamlined regulations. I believe most of these regulations should be permanently removed, so that drug and vaccine discovery don’t cost well over a billion dollars and a decade of development time. That’s not sustainable. The time and expense it takes to create a vaccine or to market a drug is a regulatory nightmare. It should never take that much time
and treasure to manufacture vaccines and drugs. But, because that’s what we’re used to, some assert that the COVID vaccines are “rushed.” That might be true relative to what we have had to live with in the last decades. The expense of vaccine and drug discovery has been escalating, to the point that manufacturers can’t afford to bring to the public many drugs that are critical to human well-being. For example, new antibiotics are too expensive to develop, because the manufacturers know they cannot turn a profit on them. This is tragic, because we now see more antibiotic-resistant bacteria than ever before. Pharmacologists see an impending crisis barreling towards us. The amount of regulation we have now is far more than was required in the 1960s, when the FDA was cautious enough to ban thalidomide for pregnant women in the United States. It is indeed cause for celebration that COVID vaccines are already being distributed, and I will not hesitate to take the vaccine, though I have a good understanding of the coronavirus and do not fear it. I think we have done what our historical moment called for, and I hope biomedicine of the future will be all the better for it.
From Page 4 speed getting to us is concerning to many. I think we have acquired cultural amnesia about vaccines. I grew up not long after the Polio scares, and in my childhood heard horror stories about outbreaks that left many in iron lungs for the rest of their lives. The disease claimed paupers and presidents; even President Franklin Roosevelt was not exempt, his body permanently weakened and crippled after acquiring the disease as a young man. Decades ago, vaccines were not taken for granted, because we were close to the plagues that still tormented us. The Spanish Flu epidemic was a century ago, and during this holiday from history we have forgotten how desperately people desire to prevent or cure or just effectively treat disease, but there was no technological cure to assuage the suffering of a century ago. We in the 21st century have drunk from the river Lethe. We have forgotten why we had to develop all these vaccines, and why it was necessary to immunize. Smallpox was a disfiguring scourge that may have killed up to 10 percent of humanity before the advent of Jenner’s inoculation. COVID-19 is not so bad as that, but it is bad enough. There has never been a coronavirus
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From Page 4 on the Democrat presidential candidate – now president-elect – but implicated him. Only after the election did we learn that data blocked could be objectively disqualifying. If members of Joe Biden’s family, close for years, are under investigation for trading access for money, who is the “him” guilty of offering access? It takes to two to tango, as they say – and Joe Biden is one of the two. All this becomes even more insidious, objectionable, and arguably unconstitutional – when explicit and implied financial assistance, political advocacy, and campaign-tipping support is aligned with the Democrat Party. In effect, political actors – soon running the federal government – have been assisted in shutting out the truth, in order to acquire power – and this power, in turn, serves the personal, financial and political agenda of those who control the social media giants. The time has come to separate mass power over information and the Democrat party. More, the time has come to open these social media giants to antitrust actions, public and private, and end the now-absurd notion that they should be immune from civil lawsuits – because they must be nurtured. They have been effectively nurtured into monster-hood, a societal overlord position that allows dominance, controls critical information, shuts off information flow essential to a free, open, and properly informed republic. What power do these players have? Beyond the ability to distort public dialogue on “matters of public concern” – including blocking a senior’s group’s December podcast discussing election lawsuits – these giants have become sources of mass dependence. Thus, by way of example, on Monday, Dec. 14, social media users around the globe personally and professionally suffered the impact of a mass access outage, shutting off access to dialogue, but also to mass databases. That downtime impacted everything from business communications, internet website accessibility, data access, and distance learning – shutting schools. The outage also illustrated how much dependence has arisen – on these information-controlling outlets. Paired with political manipulation, the outage raises serious questions about the role, responsibility, and regulation of these huge, largely uncontrolled
mean it’s a bust. Investigators can evaluate it for other conditions. Take the first FDA-approved coronavirus treatment, remdesivir. Gilead originally developed it in hopes of finding a treatment for hepatitis. That didn’t pan out – but Gilead did uncover its broad antiviral properties. But then came COVID-19. Researchers
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SIEGE
social media and high-tech companies. In a nutshell, the time has come to open these oligopolistic companies to civil liability – beginning with a repeal of section 230 of the Communications Decency Act, then aggressively regulate, deconstruct, break up, reduce the influence of and de-politicize (and hold accountable) these digital behemoths. Theodore Roosevelt – famously patriotic, pro-commerce, and profree enterprise – was among the first to call out the abuse of power by monopolies and oligopolies, and to push not only the Sherman and Clayton Antitrust Acts, but also to come down hard on the abusers of public trust – in the marketplace and the marketplace of ideas. His example is a shining one – and should make these big social media and data-manipulating giants shiver. The influence of big tech on America – our social harmony, mental health, basic human interactions, decision-making, political stability, institutional and political accountability, commerce, and contentment – in short, their manipulation of the public mind – is working at cross-purposes with democracy. It has become a threat to the free flow of information vital for sustaining a free republic, not only teaming with powerful political actors (including socialist ideologues and promoters of leftist violence), but undermining the currency of any democracy, the guarantee of citizen free speech. So, looking back on history, the most heinous deprivations of individual liberty – including impairment of the God-given freedoms of worship, assembly, travel, protest, self-defense, confronting accusers, fair trial, no false imprisonment, harm to life or limb, fear of government – all begin with loss of free speech. That is why the outrage of the moment – is a talisman of our future. If Americans will see and speak truth, enact laws that protect political, personal, and professional free speech – rather than empowering oppressors of free speech – we can rise above this. If we do not act, we will wish we had. The First Amendment is under siege – and most Americans know it. We do not need more political violence. We need free speech, and protection of it. The time – if there ever was one – is now, to say so.
vestments would have been money wasted were it not for the technological capabilities and scientific know-how these research companies already had. Knowledge developed through laboratory and computer work often has multiple applications. Just because research doesn’t pan out for the medical condition it was intended to treat, it doesn’t
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From Page 4 three days after President Trump declared a state of emergency. Pfizer was ready to move into final-stage trials by July. No one knew which, if any, vaccine candidate would succeed. But the ecosystem for private sector innovation has long been a powerful force in the United States in the development of breakthrough treatments and cures. Pharmaceutical innovation is inherently risky. Less than 12 percent of promising compounds ever make it past clinical trials to market. Taking the failures into
account, research and development costs for every success story run to the billions of dollars. A sound policy environment that promotes innovation has led to some of the most advanced research techniques of any industry – just what we needed when COVID-19 came calling. The federal government’s Operation Warp Speed identified several of the most promising vaccine candidates and guaranteed government purchases in the billions of dollars. Operation Warp Speed has also contributed directly to funding for research and development. But these federal in-
Wednesday, December 30, 2020
3/17/21
COVID-19
The Cherryville Eagle
12/26/18
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