NIH Admits Funding Enhanced a Coronavirus; Bogus Fibro Test? Unlikely Vax Heroes

— This past week in healthcare investigations

INVESTIGATIVE ROUNDUP over an image of two people looking at computer screens.

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

NIH Admits Funding Enhanced a Coronavirus

The NIH has acknowledged that it funded research in which a coronavirus was enhanced to become more infectious, Vanity Fair reported.

Last week, the agency sent a letter to the House Committee on Energy and Commerce stating that its grantee, EcoHealth Alliance, enhanced a bat coronavirus to become potentially more infectious to humans. The letter described this as an “unexpected result” of the research, which was done in partnership with the Wuhan Institute of Virology.

In what NIH describes as a “limited experiment,” lab mice infected with the enhanced virus became sicker than those infected with a naturally occurring one, Vanity Fair reported.

The NIH letter also noted that EcoHealth Alliance violated terms of its grant conditions stipulating that it was supposed to report to the agency if its work boosted viral growth by 10-fold.

An EcoHealth Alliance progress report that was supposed to be submitted at the end of the grant period in 2019 didn’t arrive at the NIH until August 2021, Vanity Fair reported. However, EcoHealth Alliance told Vanity Fair in a statement that it had reported the relevant information “as soon as we were made aware, in our four year report in April 2018.”

The Vanity Fair report also details a leaked EcoHealth Alliance grant proposal submitted to the Defense Advanced Research Projects Agency in 2018.

“One distinctive segment of SARS-CoV-2’s genetic code is a furin cleavage site that makes the virus more infectious by allowing it to efficiently enter human cells,” Vanity Fair reported. “That is just the feature that EcoHealth Alliance and the Wuhan Institute of Virology had proposed to engineer in the 2018 grant proposal.”

“If I applied for funding to paint Central Park purple and was denied, but then a year later we woke up to find Central Park painted purple, I’d be a prime suspect,” Jamie Metzl, a member of the WHO’s advisory committee on human genome editing, told Vanity Fair.

In its letter to Congress, the NIH emphasized that the virus EcoHealth Alliance was studying could not have sparked the pandemic, as the genetic differences between it and SARS-CoV-2 were too vast. NIH Director Francis Collins, MD, PhD, also issued a statement on the concerns raised by the letter, noting that such claims were “demonstrably false.”

“The scientific evidence to date indicates that the virus is likely the result of viral evolution in nature, potentially jumping directly to humans or through an unidentified intermediary animal host,” Collins said in the statement.

The agency said it was giving EcoHealth Alliance 5 days to submit any additional unpublished data from the experiments it funded.

Bogus Fibromyalgia Test?

A blood test for fibromyalgia is based on shaky science, but still marketed directly to patients, luring them with the promise of a high-profile clinical trial that isn’t even enrolling, a STAT investigation found.

The FM/a Test, made by EpicGenetics, is purported to be the “first and only blood test to accurately and definitively diagnose” fibromyalgia, as described by company representatives. It’s been marketed directly to patients via radio and TV ads.

People who test positive are given the promise of enrolling in a clinical trial being led by Massachusetts General Hospital (MGH) in Boston.

The problem is, the trial never got off the ground. Its sponsor, EpicGenetics CEO Bruce Gillis, MD, MPH, hasn’t provided MGH with any more of the $8.7 million he’d pledged beyond an initial down payment, STAT found.

Denise Faustman, MD, PhD, the MGH researcher who was supposed to lead the trial, was surprised to learn that the company had still been advertising the FDA-approved trial in 2020, and that it was still responding to patient inquiries with an email that mentioned the trial this year.

“The program’s on hold, he knows it’s on hold, so that’s a little bizarre,” Faustman told STAT.

Only one study was completed before the test went to market in 2012. One additional study was completed in 2015 — and it raised questions about how specific it was for detecting fibromyalgia, as it wasn’t as good at distinguishing it from lupus and rheumatoid arthritis compared with controls.

In recent years, the diagnosis of fibromyalgia has “crept toward legitimacy,” and even though progress has been made — it’s no longer seen as primarily psychological, for instance — it’s still not fully understood. It often takes a long time to diagnose, and there are some physicians who still don’t believe it exists at all.

But experts interviewed by STAT said there’s certainly no definitive diagnostic test that’s ready for prime time.

“It’s one of those tests that unfortunately, it made the commercial area before really good solid studies had been done to validate the efficacy,” Andy Abril, MD, chair of rheumatology at the Mayo Clinic in Jacksonville, Florida, told STAT.

Dan Clauw, MD, director of the University of Michigan’s Chronic Pain and Fatigue Research Center in Ann Arbor, said he gives “tons of talks. If someone asks me the question, I’ll say, ‘There is no diagnostic test for fibromyalgia.'”

Gillis argued that skepticism about the test is merely part of skepticism about the condition in general, and he insists he’s doing what’s best for the fibromyalgia community.

Unlikely Vax Heroes

The two men who brought COVID-19 vaccines not just to the U.S. but to the world were two industry “outsiders” whose companies long struggled to survive.

That’s according to a piece in the Wall Street Journal adapted from a new book by reporter Gary Zuckerman, titled “A Shot to Save the World: The Inside Story of the Life-or-Death Race for a COVID-19 Vaccine.”

Ugur Sahin, MD, of BioNTech, and Stéphane Bancel, of Moderna, worked hard to keep their fledgling biotechs afloat. In 2019, BioNTech raised just $150 million during its initial public offering, “just over half of what it had hoped for,” WSJ reported. That was after a forced discount on its share prices — and shares still managed to fall more than 5% on their debut.

Bancel’s Moderna had limited cash, had never run a late-stage trial, and hadn’t done any work on vaccines. If their mRNA vaccine candidate failed, “investors would never forgive it,” WSJ reported. The company almost ran out of money in the spring of 2020 after Bancel failed to raise needed cash.

The book is an inside look at the pressure facing these unlikely heroes, and how they ultimately brought effective COVID-19 vaccines to the world. The book is based on interviews with Sahin, Bancel, and hundreds of scientists, executives, investors, and other company insiders.

Kristina Fiore leads MedPage’s enterprise & investigative reporting team. She’s been a medical journalist for more than a decade and her work has been recognized by Barlett & Steele, AHCJ.

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