How the FDA Found Out About U of I's False Claims to EUA
Where there's smoke, there's fire.
August 19th, 2020 was a celebratory day for the University of Illinois & Governor Pritzker. A SARS-CoV-2 saliva test developed at the state’s largest taxpayer-funded school was now under FDA emergency use authorization (EUA), the school announced. The test “on the market,” as Pritzker put it at the press conference. He pledged the state of Illinois would be its “biggest customer.”
At the time, I was very critical of both U of I’s test and their covid-19 mitigation policies. A follower of my now-suspended Twitter account noticed my concerns and messaged me privately with questions about the school’s claim to an EUA. We investigated further and concluded that the school wasn’t telling the truth.
To confirm, I sent two emails on September 16th. The first was to Dr. Nathan Grubaugh, lead researcher for SalivaDirect. I asked if he could confirm that Yale had authorized U of I’s test by way of “designating” U of I’s lab.
He said no.
After a few more emails in which I pointed to statements U of I made, Dr. Grubaugh summarized:
“Illinois did not formally request to be authorized under our EUA, has not bridged on a EUA, or asked for a right of reference to our data - though we’d be happy to do any of these. It’s our understanding that they are using [their test] as an LDT without an EUA.”
He said his reached out to U of I to issue a correction, as well as to the FDA.
My second email was to Timothy Stenzel, Director, Office of In Vitro Diagnostics & Radiological Health at the FDA.
An assistant to Mr. Stenzel replied with information about Yale’s EUA and said, “At this time, we are not aware of an EUA for Illinois.” I followed up by sending Dr. Grubaugh’s response to me, with links to claims that the Governor of Illinois and Senator Dick Durbin’s made about the test’s (non-existent) EUA, and evidence of SHIELD T3’s intent to market the test beyond the University.
That same day, the FDA’s Luna Zaritsky reached out to co-developer of the test Martin Burke. “We’d like to talk about your saliva test,” she wrote, “including the specifics about bridging studies vs. EUA authorization.”
Burke obliged, and referred to a “pre-EUA” submitted on August 18th, the day before U of I’s announcement.
The virtual meeting took place on September 21st. U of I’s FOIA office says it wasn’t recorded on SHIELD’s end, but a follow-up email from Toby Lowe, Assistant Director for Regulatory Programs at the FDA, summarizes the discussion.
The FDA had “heard from multiple parties that there is confusion about whether your test is FDA authorized and/or whether it falls under the Yale SalivaDirect EUA.” The test did not have authorization - via Yale or any other mechanism. The agency was clear about how and why the University was wrong and potential sources of “confusion,” and provided specific language for correcting associated web page content.
Ms. Lowe also directed the U of I team to an errant tweet from Governor Prtizker’s and announcements from U.S. Senator Dick Durbin, noting that both “mischaracterized” the authorization status of the saliva test. (As far as I know, neither official issued formal corrections.)
On September 29th, Illinois Newsroom broke the story about U of I dialing back its claims about its test. Martin Burke’s reaction was that the school’s August 19th announcement was “fully consistent with our understanding of the [federal] guidelines at the time.”
The next day, Jay Walsh - the U of I’s Interim VP for Economic Development & Innovation - responded to the FDA’s post-meeting email with a summary of actions taken to correct the misstatements about the saliva test. He said a pre-EUA was sent to the FDA on August 11th (vs. on August 18th, like Burke said).
It’s puzzling that, after interacting with the agency around the pre-EUA, the school decided it could claim it had “bridged” to Yale’s test (which had been granted a legit EUA on August 15th).
It’s also interesting that U of I was using the test with asymptomatic students & staff as a condition of being on campus, but hadn’t received FDA guidance for doing so, or gathered evidence in support of that strategy.
In her reply to Walsh, Lowe cited a discrepancy between U of I’s “pre-EUA” intent, and the intentions Walsh expressed. She observed that the school first wanted authorization for use in its own lab, but then changed its tune and was seeking EUA for wider use.
I don’t have Walsh’s response, but based on what the University was already doing - and on subsequent events - he likely said the entity was seeking authorization for wider use.
The next day, the Chicago Tribune reported the story. U of I again attributed its false claim to confusion. I explained in this postwhy their excuses didn’t (and still don’t) make sense.
I know what you’re thinking, dear reader: Why bring up this mess now, nearly two years later?
For starters, marketing or signing external contracts for a test prior to EUA is not legal. To my knowledge, there was no investigation into whether U of I or SHIELD T3, LLC did either of those things. It appears from this September 2020 news report that SHIELD T3 hadn’t wasted any time selling the test, which isn’t surprising, given the intentions for the enterprise.
Unfortunately, where there’s smoke, there’s fire. The EUA fib is not the only “flag” that U of I’s covid-testing enterprise has raised. Journalist Mark Konkol reported the steps Governor Pritzker and his agencies took to remove any barriers to giving SHIELD exclusive access to $225 million dollars for covid testing in K12 schools.
What’s also unclear is the flow of money into & out from SHIELD. Where did U of I get the money to fund it? Who all benefits financially and politically from SHIELD T3, the for-profit LLC arm? What are the advantages of the *non-profit* SHIELD Illinois? (Not having to file form 990 is one…) Are any elected or appointed public officials invested in SHIELD? How about members of the U of I Board of Trustees — including the one who serves ex-officio and whose campaign has used SHIELD T3 for covid testing?
In future posts, I’ll detail other other issues with regard to U if I’s validity study, research protocols, & informed consent — plus SHIELD’s influence over state & CDC school covid guidelines.
Until then, people with power, influence, and moral fortitude would be wise to push for an official investigation into this testing regime.
U of I was eventually granted EUA on February 24, 2021, but it wasn’t until April 2, 2021 that its authorization (and SalivaDirect’s) included specific language about use of the test with “individuals without symptoms or other epidemiological reasons to suspect COVID-19.” The EUA also lists as a limitation, “Performance of covidSHIELD has only been established with saliva specimens from symptomatic individuals. Use of covidSHIELD with other specimen types has not been assessed and performance with these sample types is not known. Performance of this test was not evaluated in an asymptomatic patient population from individuals suspected of COVID-19 by their healthcare provider.”
Originally posted on Twitter October 10, 2020
My son was suspended from my beloved alma mater for failing to comply with the twice weekly testing requirement AFTER he recovered from Covid. The SHIELD program needs to be exposed!! Who owns if? Who has profited from it? Whose political influence fast tracked it? And who’s lies gave it legitimacy? Please keep digging
There needs to be massive lawsuits