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Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

The Nonprofit at the Center of the COVID Origin Debate

Vanity Fair's Katherine Eban , the American non-profit with extensive ties to the Wuhan Institute of Virology that has fueled fires favoring a lab-leak origin for COVID-19.

The organization went from a struggling nonprofit focused on saving manatees (under the name Wildlife Trust) to winning multi-million-dollar federal grants to study pandemic prevention.

Its first big break came in 2009 when it won $18 million as part of a USAID pandemic prevention effort called PREDICT. But its leader, Peter Daszak, PhD, had been collaborating for years prior to that with Shi Zhengli, PhD, of the Wuhan Institute of Virology (WIV).

Daszak and Zhengli published their first paper together in 2005 -- on how horseshoe bats were a likely reservoir for SARS-like viruses. EcoHealth Alliance subcontracted $1.1 million of the PREDICT grant to WIV, Vanity Fair reported.

Eban details the work spawned by this alliance that has sparked several flash points in the SARS-CoV-2 origin debate. "Gain-of-function" research by Zhengli and collaborator Ralph Baric, PhD, of the University of North Carolina at Chapel Hill, involved the creation of two chimeric coronaviruses that were similar to the one that caused the 2002 SARS outbreak. One of those viruses was able to directly infect human cells, Vanity Fair reported.

In pursuit of securing future funding, EcoHealth Alliance also pitched the Defense Advanced Research Projects Agency (DARPA), which was seeking proposals for another pandemic prevention effort, called PREEMPT. The group wanted to examine SARS-like bat coronaviruses for furin cleavage sites and possibly insert new ones that would enable them to infect human cells. Vanity Fair noted that SARS-CoV-2 is notable for having a unique furin cleavage site that has led some scientists to consider whether the virus emerged from a lab. (DARPA rejected the proposal.)

Eban also details what appears to be concerted efforts by scientists to dismiss a lab-leak theory early in the pandemic.

On Feb. 1, 2020, NIAID Director Anthony Fauci, MD, emailed his deputy director Hugh Auchincloss, MD, with a subject line of "IMPORTANT," attaching the 2015 Baric and Zhengli paper. Later that day, Fauci joined a call, convened by Jeremy Farrar, director of the U.K.'s Wellcome Trust, that included a limited group of other top scientists including then-director of the NIH Francis Collins, MD, PhD, Kristian Andersen, PhD, and Robert Garry, PhD.

Over the next 4 days via email, the scientists scrutinized SARS-CoV-2's genetic sequence, paying special attention to the furin cleavage site. Initially, Andersen, Garry, and others found it "inconsistent with expectations from evolutionary theory." However, within a few days, four of the scientists who were on that call shared with Fauci the draft of a letter that argued a lab-leak theory was unlikely. It was .

About a month before that, condemning "conspiracy theories" that COVID-19 doesn't have a natural origin. Daszak played a key role in organizing that paper, Vanity Fair reported.

Simon Wain-Hobson, PhD, of the Pasteur Institute in Paris, who has criticized gain-of-function research, told Vanity Fair that the group of scientists pushing the claim of natural origin "want to show that virology is not responsible [for causing the pandemic]. That is their agenda."

Malone Didn't Invent mRNA Vax

Robert Malone, MD, has become one of the loudest voices among physicians who spread COVID misinformation, buoyed by the claim he invented the mRNA vaccines -- but that claim is far from the truth, .

The Times spent 2 days interviewing Malone at his 50-acre horse farm in Madison, Virginia -- about 2 hours southwest of Washington, D.C. -- where he was busy with appearances on conservative media, including Fox News and One America News.

He frequently uses his "inventor" status to question the safety of the mRNA vaccines, but COVID-19 experts, including three researchers who worked closely with Malone, told the Times his role was minimal at best.

Malone earned a medical degree from Northwestern University in 1991, and subsequently taught pathology at the University of California Davis and the University of Maryland over the next decade, before turning to biotech start-ups and consulting, the Times reported.

Malone did do work showing human cells could absorb RNA and produce proteins from it, as evidenced by a 1990 paper. But Malone was not the lead author, and at the time it wasn't known how to protect the genetic particles against immune system attack.

A co-author on that paper, Gyula Acsadi, MD, PhD, said none of the other authors would claim they had invented the mRNA vaccine, based on that paper.

"Some of his work was important, but that's a long way away from claiming to have invented the technology that underpins the vaccines as we use them today," Alastair McAlpine, MD, a pediatric infectious disease physician in Vancouver, told the Times.

The vaccines "are the result of hundreds of scientists all over the world, all combining to come together to form this vaccine," McAlpine said. "It was not one individual or the pioneering work of an individual person."

Valisure Wrongfully Investigated?

An FDA investigation into Valisure -- the upstart company that has detected carcinogens in several drugs and consumer products, leading to major recalls -- is dragging on and may be irrelevant, .

About 7 months ago, the agency spent several weeks combing through Valisure's lab facilities and accused it of operating without proper regulatory approvals, Consumer Reports found. The agency believes Valisure conducts tests for companies seeking FDA approval, but Valisure CEO David Light told Consumer Reports his company doesn't do that type of regulatory work.

Light added that the FDA has not communicated with him since that inspection.

Consumer Reports was able to obtain a copy of the 56-page inspection report, even though such reports are only supposed to be available when inspections are complete. (A FOIA officer subsequently realized the investigation was still open and asked Consumer Reports to destroy its copy.)

The inspection report held no evidence to support allegations that Valisure is doing preapproval testing for manufacturers, according to Consumer Reports.

Meanwhile, manufacturers of products that were recalled used the FDA investigation to undermine lawsuits brought by consumers who purchased goods implicated by Valisure's testing, the article states. It's not clear how manufacturers cited in the lawsuits found out about FDA's inspection of Valisure, as open investigations are confidential, Consumer Reports noted.

Valisure appeared on the scene in 2019 after discovering in the blood pressure medication valsartan. Later that year, it revealed N-nitrosodimethylamine in the heartburn drug ranitidine. Last year, Valisure detected benzene in hand sanitizers, and then in several sunscreen sprays, and finally, in deodorants.

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