EDITOR’S NOTE: This is the third article in our ‘Gain-of-Function Hall of Shame’ series profiling key players in gain-of-function research.

Guess what year this ScienceDaily headline appeared:

“New SARS-Like Virus Can Jump Directly from Bats to Humans, No Treatment Available.”

If you guessed 2020, you’re wrong. The article was published in 2015. The source was the University of North Carolina at Chapel Hill. That’s where scientist Ralph Baric, Ph.D, and a team that included Baric’s Wuhan Institute of Virology (WIV) colleague, Shi Zhengli, used genetic engineering and synthetic biology to create a “new bat SARS-like virus . . . that can jump directly from its bat hosts to humans.”

Baric is known as the Coronavirus Hunter. Zhengli’s nickname is Bat Woman.

The two are scientists whose work involves collecting samples of the nearly 5,000 coronaviruses in bat populations and manipulating them for the sole purpose of making them more infectious to humans. 

Ostensibly, the research Baric and Zhengli conduct is intended to help scientists get ahead of any coronavirus that might have the potential to emerge as a human pathogen. 

However, there is little evidence that this research has prepared us to meet the challenges of the current COVID-19 pandemic. In fact, there are suspicions that the research may have caused the virus.

As André Leu recently reported for Organic Consumers Association, Baric’s work on the coronavirus team began in 2001. That’s when he assembled a full-length mouse coronavirus—and then removed all the inserts that showed that the virus had been genetically engineered. 

The following year, for the first time, a coronavirus jumped from animals to humans, causing a worldwide outbreak that resulted in 8,000 cases and nearly 800 deaths.

Baric and Zhengli’s 2015 project, “Generating Infectious Clones of Bat SARS-Like CoVs,” involved altering a SARS-CoV virus so it could latch onto the ACE2 receptor, a protein that provides the entry point for the coronavirus to hook into and infect a wide range of human cells. (Some evidence suggests that ACE2 receptors may be more numerous in patients with hypertension, diabetes and coronary heart disease, one reason these comorbidities may contribute to susceptibility to COVID-19).

Baric and Zhengli’s work was “notable not only because there is no treatment” for this newly created virus, ScienceDaily reported, “but also because it highlights an ongoing debate over the government’s decision to suspend all gain-of-function experiments on a variety of select agents earlier this year.”

Gain of function experiments aim to improve the ability of a pathogen to cause disease. “Select agents” are biological agents and toxins that have the potential to pose a severe threat to public health and safety.

The “government’s decision to suspend all gain-of-function experiments on a variety of select agents” refers to the Obama administration’s moratorium on gain-of-function research, officially called the 2014 U.S. Government Deliberative Process Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS and SARS Viruses. 

Baric, Zhengli and their team acknowledged in their published study, “A SARS-Like Cluster of Circulating Bat Coronaviruses Shows Potential for Human Emergence,” that their work was allowed only because it was initiated before the 2014 funding pause on gain-of-function research involving SARS viruses, and also because the National Institutes of Health approved an exemption requested by the researchers.

The Baric-Zhengli team’s work was immediately criticized. Richard Ebright, a molecular biologist and biodefense expert at Rutgers University in Piscataway, New Jersey, told Nature: “The only impact of this work is the creation, in a lab, of a new, non-natural risk.”

Playing dumb . . . to protect the guilty?

On May 25, 2020, after the emergence of COVID-19, Baric was interviewed by North Carolina Public Radio. In the interview, he was asked this:

“There is a controversy about the laboratory in Wuhan, China. Do they have the kind of safety precautions that you have at the University of North Carolina, and do you have any thoughts about whether this virus was a natural bat-to-human transfer? Or was there something a little bit more, perhaps, insidious involved?” 

Baric responded:

“Well, of course, the answers to those questions are in China and it’s very difficult to imagine that anyone else would know the answer to that question except for people in China. 

“But, I will say this about their facilities. They have a state-of-the-art BSL3/BSL4 facility that was designed and actually discussed with groups here in the United States that also have BSL3 and BSL4 facilities and so the design and the function of that facility, in terms of its safety, has been well reviewed. Exactly how they work in that facility is something that would be very difficult for a Westerner to know unless they had access to the facility and it’s very difficult to get into any nation’s high-containment BSL3/BSL4 facility. So, I don’t know the answer to that question. 

“The main problem that the Institute of Virology has is that the outbreak occurred in close proximity to that institute. That institute has the best collection of virologists in the world, that have gone out and sought out and isolated and sampled bat species throughout Southeast Asia. And so they have a very large collection of viruses in their laboratory. Proximity is a problem. It makes it look bad in any event, and there’s no way to stop that speculation unless China decides to do an open transparent review of what was in the facility and what was going on at that time.”

Why is Baric so quick to implicate the lab he collaborates with—without acknowledging his connection to it?

Why does Baric position the WIV as the only possible lab source of the virus when, as a coronavirus researcher, he knows of dozens of labs around the world—including his own—that collect, store and manipulate bat viruses?

Baric claims that it would be “very difficult for a Westerner to know” how scientists work in the Wuhan lab “unless they had access to the facility, and it’s very difficult to get into any nation’s high-containment BSL3/BSL4 facility.”

Is it possible that Baric was unaware of the news the Washington Post broke on April 14, 2020? The Post reported:

“Two years before the novel coronavirus pandemic upended the world, U.S. Embassy officials visited a Chinese research facility in the city of Wuhan several times and sent two official warnings back to Washington about inadequate safety at the lab, which was conducting risky studies on coronaviruses from bats.”

It seems unlikely that Baric would have missed the Washington Post story, given that the State Department cables cited by the Post specifically mentioned the work Baric had done in collaboration with the Wuhan lab:

“‘Most importantly,’ the cable states, ‘the researchers also showed that various SARS-like coronaviruses can interact with ACE2, the human receptor identified for SARS-coronavirus. This finding strongly suggests that SARS-like coronaviruses from bats can be transmitted to humans to cause SARS-like diseases. From a public health perspective, this makes the continued surveillance of SARS-like coronaviruses in bats and study of the animal-human interface critical to future emerging coronavirus outbreak prediction and prevention.’

“‘The research was designed to prevent the next SARS-like pandemic by anticipating how it might emerge. But even in 2015, other scientists questioned whether Shi’s team was taking unnecessary risks. In October 2014, the U.S. government had imposed a moratorium on funding of any research that makes a virus more deadly or contagious, known as ‘gain-of-function’ experiments.”

One way to excuse Baric’s omissions is to presume that he didn’t want to add fuel to the fire of “debunked conspiracy theories,” namely that the virus “was spread from North Carolina to China, Italy and elsewhere in the U.S. by the “Deep State” in a plot ‘to destroy the Trump economy.’”

There’s one omission that is very hard to excuse: Baric was in Wuhan in 2018, delivering a plenary lecture at the 8th International Symposium on Emerging Viral Diseases sponsored by the Wuhan Institute of Virology. As he says, proximity is a problem. 

But this side-steps the real issue, which is this: Regardless of whether this virus occurred naturally or escaped from a lab, is it really a good idea to manipulate viruses to make them more deadly?

Presumably, Baric would justify his coronavirus research by showing that the millions of dollars the U.S. government invested in his gain-of-function experiments prepared us for COVID-19, making it easier, quicker and cheaper to develop effective medical countermeasures. 

Unfortunately, the opposite appears to be true: All those millions spent on Baric’s research has turned out to be a dangerous boondoggle.

Public scientist or private drug developer?

Baric works at a public university. His research is funded by U.S. (taxpayer-funded) government grants. So in theory, this should create the ideal conditions for him to do scientific work that needn’t be geared toward churning out commercially successful products.

In reality, the ideal of public science as a social function, where the scientist’s only commitment is to improving human health and knowledge through discovery, was discarded back in 1980. 

In her book, “University Inc.: The Corruption of Higher Education,” Jennifer Washburn explains how in 1980, a law known as Bayh-Dole, was passed which allowed universities to own property rights to federally funded research and to license that research to industry in exchange for royalties.

Since then, the worth of scientists has come to be measured more by products than publications, and scientists like Baric have channelled their discoveries toward drug development. Scientists also have been incentivized to take on potentially lucrative partnerships with pharmaceutical companies, or to launch their own startups.

Now, the drugs Baric has developed—and stands to profit from—are at the center of a Trump administration scandal involving billions of dollars in COVID-19 drug and vaccine development contracts going to Trump’s cronies, his family and his administration’s top officials.

Let’s connect the dots between the Bayh-Dole Act, Baric and two drugs being pushed as cures or treatments for COVID-19.

EIDD-2801 (now Merck’s MK-4482): Birth defects? No worries. Big Pharma helped pass a law that lets drugmakers off the hook

Rick Bright, former head of the Biomedical Advanced Research and Development Authority (BARDA), lost his job over a drug originally known as EIDD-2801, now known as Merck’s MK-4482. Here’s how that went down.

During a November 1, 2019 meeting, before the first cases (or at least, publicly known cases) of COVID-19 emerged, Bright was asked by his boss, Assistant Secretary of Preparedness and Response (ASPR), Robert Kadlec, and ASPR Senior Science Advisor, Christian Hassell, to stockpile EIDD-2801.

Kadlec brought friends in to make the case. Pharmaceutical industry lobbyist John Clerici and George Painter, director of the Emory Institute for Drug Development (EIDD—hence the drug’s name), along with president and CEO of Drug Innovation Ventures at Emory (DRIVE), declared during the meeting that EIDD-2801 was a “miracle cure” and a “cure-all” for influenza, Ebola and nearly every other virus. Painter said it could be “a great asset to national security.”

In reality, EIDD-2801 was just a drug that they hadn’t been able to pawn off on anyone in the private sector because it was associated with birth defect risks. Then along came the COVID-19 pandemic, and with it, new possibilities for EIDD-2801. 

Why? Because if EIDD-2801 could be sold to the government as a pandemic, epidemic or bioterrorism countermeasure, there would be no need to worry about birth defects—thanks to legislation that Clerici had been instrumental in passing. 

Under the Public Readiness and Emergency Preparedness (PREP) Act, a bill that Clerici was “pivotal” in drafting and passing, the government provides “substantial liability protections for makers and distributors of pandemic, epidemic, and bioterrorism countermeasures.”

Painter’s colleague, EIDD Executive Director Dennis Liotta, had developed EIDD-2801 when he and Raymond Schinazi, another Emory University scientist who has no connection to DRIVE, co-owned the pharmaceutical company Pharmasset. Because of the concern about birth defects, they dumped EIDD-2801 before they sold Pharmasset to Gilead Sciences in 2011, for $11.2 billion. As Schinazi told Science magazine, Pharmasset had abandoned EIDD-2801 back in 2003, after discovering its mutagenic properties. 

Bright knew about these problems with reproductive toxicity in animals, including that some offspring from animals treated with EIDD-2801 had been born without teeth and without parts of their skulls. 

Since Emory had already received $30 million in government funding from the National Institutes of Health (NIH) and the Department of Defense to fund toxicity studies and initial clinical trials, Bright suggested that they complete these studies and then, if they had evidence that the drug was safe, return to BARDA later.

“Thank goodness someone is raising the red flag,” about EIDD-2801, Schinazi told Science magazine. “You don’t develop a drug that’s mutagenic. Period.”

As Clerici and Painter were contemplating their next move, word of a virus spreading in Wuhan, China, was starting to make news. According to the EIDD-2801 origin story they told Chemical & Engineering News, Baric, one of Painter’s collaborators, immediately alerted Painter to the fact that the new pathogen was probably a coronavirus—one that EIDD-2801 could potentially combat.

Mark Denison, their collaborator at Vanderbilt University, told Chemical & Engineering News that the research team had known that a coronavirus outbreak was inevitable. Denison told the publication:

“Every single one of our grants, every single one of our papers predicted that this event was going to happen that’s occurring right now. The whole goal of our drug development was to plan for this.”

Painter told Chemical & Engineering News: “We thought, ‘Oh my god, it’s a coronavirus. We should be ready.’”

They didn’t have any new science, but in February 2020, Painter, Kadlec and others went back to Bright. He still wouldn’t budge. When Kadlec couldn’t pressure Bright to buy EIDD-2801, he removed him from BARDA.

With Bright out of the way, the campaign for EIDD-2801 continued. 

In March 2020, Ridgeback Biotherapeutics, owned by Wayne Holman and Wendy Commins Holman, purchased an exclusive license to EIDD-2801 from DRIVE for an undisclosed amount. 

In May 2020, Ridgeback flipped the drug, selling it to Merck, which renamed it MK-4482.

MK-4482 could become a blockbuster drug, stockpiled by governments and hospitals to treat COVID-19 and future coronavirus outbreaks. Painter told Chemical & Engineering News that ideally, MK-4482 would be administered  once someone has been exposed to SARS-CoV-2—to prevent infection—or up to a week or so after someone has been infected.

Earnings and forecasts are up for Merck, in part because of anticipation of marketing MK-4482 as an oral antiviral Covid-19 treatment.

Painter has been promoting the idea of using MK-4482 in combination with another antiviral Baric works on, Remdesivir.

The better to hide any adverse reactions?

Remdesivir: The Ebola drug reject taxpayers have pent $70.5M on . . . so far

Remdesivir, like EIDD-2801, is a drug looking for a market. In January 2020, Fierce Biotech ran an article about Gilead’s plan to cash in othe the coronavirus pandemic with a drug that it hadn’t been able to make any money on yet:

“Gilead Sciences is considering repositioning . . . remdesivir as a treatment for the coronavirus now sweeping across parts of China. The antiviral last made headlines when Gilead tested it, with little success, as a treatment for Ebola virus.

“As happened during the Ebola outbreak, the surge in cases of infection with a potentially fatal strain of the coronavirus in parts of China has led to a flurry of statements from biotechs with assets they claim could help keep the virus under control.

“Based on previous outbreaks, few, if any, of the programs now being talked up will lead to drugs that make a difference, either therapeutically or commercially . . . Gilead has a drug that has already been tested in humans. That positions Gilead to respond more quickly to the outbreak, although it also leaves scope to doubt whether it has a drug capable of tackling coronavirus.

“Gilead pushed remdesivir forward quickly in collaboration with the Centers for Disease Control and Prevention and the U.S. Army Medical Research Institute for Infectious Diseases in response to the West African Ebola virus epidemic that began in 2013. The R&D program culminated in a randomized controlled clinical trial that tested remdesivir and three other drugs in patients with Ebola.

“The trial found two of the drugs were more effective than remdesivir, putting an end to efforts to establish [it] as a treatment option in Ebola.” 

Public Citizen estimates that taxpayers have, so far, contributed at least $70.5 million to develop remdesivir, and argues that if it turns out it works, Americans shouldn’t have to pay twice for it. Instead, remdesivir should be distributed to patients for free through a public health system.

But, this begs another question: Is all the money that has been invested in—and could be made from—this drug, preventing the government from being objective as to the drug’s actual promise?

Critics say Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, skewed results of the remdesivir trials—and still got weak results. 

Meryl Nass, in her blog post, “Faking Results: Fauci’s NIAID-paid Remdesivir Study Changed Its Outcome Measures Twice, in Order to Show Even a Whiff of Benefit,” writes:

“Fauci … has done the unthinkable in medicine: changed the goalposts, twice, on his remdesivir study in order to provide the appearance of benefit. Even then, benefit was quite small.”

This surely has nothing to do with the fact that at least eight members of the NIH panel that writes COVID guidelines have financial interests in Gilead Sciences.

The only conclusion one can reasonably draw from Baric’s story is that scientists who engage in risky gain-of-function research are much better at creating more dangerous viruses than they are at curing them.

Please sign our petition demanding a global ban on gain-of-function research.

Alexis Baden-Mayer is OCA’s political director. To keep up with OCA’s news and alerts, sign up here.