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 Stphane 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 MedPages enterprise & investigative reporting team. Shes been a medical journalist for more than a decade and her work has been recognized by Barlett & Steele, AHCJ, SABEW, and others. Send story tips to k.fiore@medpagetoday.com. Follow
Sevenmore Mainers have died while health officials on Wednesday reported another 620coronavirus cases across the state.
Wednesdays report brings the total number of coronavirus cases in Maine to 102,469,according to the Maine CDC. Thats up from 101,849 on Tuesday.
Of those, 73,132have been confirmed positive, while 29,337were classified as probable cases, the Maine CDC reported.
Four men and three women have succumbed to the virus, bringing the statewide death toll to 1,154.
Two were 80 or older, two were in their 70s and 60s and three were in their 50s. They were from Cumberland County (1), Kennebec County (1), Penobscot County (3) and Somerset County (2).
The number of coronavirus cases diagnosed in the past 14 days statewide is 6,636. This is an estimation of the current number of active cases in the state, as the Maine CDC is no longer tracking recoveries for all patients. Thats down from 6,909 on Tuesday.
The new case rate statewide Wednesday was 4.63 cases per 10,000 residents, and the total case rate statewide was 765.61.
Maines seven-day average for new coronavirus cases is 460.1, down from 464 the day before, down from 489.6 a week ago and down from 469 a month ago. That average peaked on Jan. 14 at 625.3.
The most cases have been detected in Mainers younger than 20, while Mainers over 80 years old make up the majority of deaths. More cases have been recorded in women and more deaths in men.
So far, 2,759 Mainers have been hospitalized at some point with COVID-19, the illness caused by the new coronavirus. Of those, 209 are currently hospitalized, with 74 in critical care and 34 on a ventilator. Overall, 46 out of 361 critical care beds and 209 out of 305 ventilators are available.
The total statewide hospitalization rate on Wednesday was 20.61 patients per 10,000 residents.
Cases have been reported in Androscoggin (10,779), Aroostook (3,940), Cumberland (21,890), Franklin (2,311), Hancock (2,797), Kennebec (9,763), Knox (1,984), Lincoln (1,804), Oxford (5,129), Penobscot (12,161), Piscataquis (1,321), Sagadahoc (1,986), Somerset (4,371), Waldo (2,454), Washington (1,854) and York (17,923) counties. Information about where an additional two cases have been reported wasnt immediately available.
An additional 3,853 vaccine doses were administered in the previous 24 hours. As of Wednesday, 915,285 Mainers are fully vaccinated, or about 77.3 percent of eligible Mainers, according to the Maine CDC.
As of Wednesday morning, the coronavirus had sickened 45,619,660 people in all 50 states, the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands and the U.S. Virgin Islands, as well as caused 738,949 deaths, according to the Johns Hopkins University of Medicine.
More articles from the BDN
DENVER (KDVR) TheCOVID-19 positivity and incidence rateshave risen over the last week in Colorado.
As of Monday, the states 7-day positivity rate is 8.46%, which is up from 6.86%. The highest positivity rate in the state over the past seven days is Custer County with 22.7% positivity.
From Oct. 18 to Oct. 25,39 counties saw an increase in COVID-19 positivity, 22 saw a decrease in COVID-19 positivity, two counties administered fewer than 10 tests in the past week, and one county had a 0% positivity after administering fewer than 10 tests last week.
Hospitalizations are climbing sharply in Colorado, hitting thehighest levels since the end of 2020.
According to the New York Times COVID-19 map, Colorado is a COVID-19 hotspot right now.
According to theColorado Department of Public Health and Environment, the incidence rates are on the rise over the last seven days.
Heres a look atpositivity rates for every county over the last seven days:
SIOUX FALLS, S.D. (KELO) -- While October started warm, the second half of the month has cooled, but some areas are still waiting to see the October cold.
Clouds and rain stayed for much of eastern KELOLAND today, and along with it temperatures remained steady with numbers near 50 degrees. The clouds have helped many in KELOLAND stay relatively warm during the overnights as many finally fell to the 20s for lows last weekend. But, we do have others that are still waiting for their first 20-degree morning of the season.
Ulster and Dutchess counties on Wednesday reported a drop in active coronavirus cases, according to government online dashboards.
Here are the local COVID statistics as of Wednesday.
Ulster County: 253, down 12 from the 265 reported Tuesday. (Peak was 2,622 on Jan. 30.)
Dutchess County: 461, down 38 from the 499 reported Tuesday (Peak was 2,576 on Jan. 16.)
Ulster County: 3.9%.
Dutchess County: 2.44%.
Ulster County: 19,185 confirmed cases, 18,645 recoveries. Deaths are at 287, with no new fatalities reported Wednesday.
Dutchess County: 35,834 confirmed cases. Deaths are at 500. No new fatalities reported Wednesday.
As of Tuesday, data according to New York states online vaccine tracker.
Ulster County: 66.3% of the population fully vaccinated, 72.9% with at least one dose of a two-dose regimen, 83.2% of those 18 and older with at least one dose.
Dutchess County: 61.2% fully vaccinated, 68.1% with at least one dose of a two-dose regimen, 78.5% of the 18+ population with at least one dose.
Appointments: vaccinateulster.com, bit.ly/dut-vax, bit.ly/ny-vaxme.
Here are the latest reports of COVID cases in area school districts.
Kingston: Two high school students.
Saugerties: One student each at Morse Elementary School and Riccardi Elementary School; two students at Mount Marion Elementary School; and nine students at Saugerties High School.
Wallkill: One student at Plattekill Elementary School.
Marlboro: One student at Marlboro Middle School.
Red Hook One student at Linden Avenue Middle School and one staff at Mill Road Intermediate School.
For online local coverage related to the coronavirus, go to dailyfreeman.com/tag/coronavirus.
Editors note: This story was amended on Oct. 27, 2021, at 6:28 p.m. to correct the change in active cases in Ulster County.
DENVER Coloradans wishing to attend sporting events or music shows at Ball Arena or the Paramount Theatre will be required to be vaccinated against COVID-19 or show proof of a negative test starting Nov. 10.
The announcement made Wednesday afternoon by Kroenke Sports & Entertainment doesnt just apply to fans. Employees and team personnel 12 years and older will also have to abide by the new policy, company officials said in a news release.
Those showing up with a negative COVID-19 test will need to make sure theyve taken a test within 72 hours prior to the event theyre attending, the release states.
Kids under the age of 12 a group who is not yet eligible for the COVID-19 vaccine will not be required to show proof of vaccination or proof of a negative COVID-19 within 72 hours of an event, but must wear a face mask at all times, company officials said.
Everyone inside Ball Arena of the Paramount Theatre will be required to wear a face mask at all times, regardless of their vaccination status, the company said. The policy will remain in place until further notice.
After consultation with local, state and federal government and health authorities along with the guidance of the National Basketball Association (NBA), National Hockey League (NHL), National Lacrosse League (NLL) and in consultation with national concert promoters and entertainment providers, the decision to institute these protocols for all events reinforces KSEs continued commitment to ensure that the health, safety and wellness of our fans, frontline workers, staff, performers and athletes is our top priority, said Matt Hutchings, EVP and Chief Operating Officer.
Hutchings said staff would be verifying vaccine cards or negative tests outside the entrances at each facility, and encouraged fans to arrive early and come prepared with their COVID-19 vaccine cards, proof of a negative COVID-19 test and their face masks before heading out.
The new policy makes no mention of medical or religious exemptions, and differs from mandates imposed in countries like France, where people are allowed to show proof that theyre recovering from a prior COVID-19 infection for a period of up to six months in order to eat out, go to museums or enter a movie theater.
Information about events taking place at Ball Arena or the Paramount Theatre on Nov. 10 and after at both venues can be found here and here. Information for events taking place now through Nov. 9 can be found here and here.
Kroenke Sports & Entertainment is the latest company in town to require proof of vaccination against COVID-19.
All resident companies of downtown Denvers Performing Arts Complex the Colorado Ballet, the Colorado Symphony, the Denver Center for the Performing Arts and Opera Colorado announced in late August they would require COVID-19 vaccines and face masks for indoor, public performances starting Oct. 1.
Earlier that month, AEG Presents, one of the largest concert operators in the country, also announced it would require people to show proof of vaccination at its clubs, theatres and festivals by Oct. 1. Venues under the umbrella of the concert operator include Denvers Bluebird Theater, Mission Ballroom and Ogden Theatre, Englewoods Gothic Theatre, Broomfield's 1stBank Center, and Fiddlers Green Amphitheatre in Greenwood Village.
Concert venues that work with Z2 Entertainment must also show proof of vaccine or a negative test result within 72 hours of a show. Those venues include the Boulder Theater, Fox Theatre and Aggie Theatre.
