So I woke up Sunday morning and said to myself. Self, let’s check out this TestUtah system that TestIowa and TestNebraska are spending tens of millions of taxpayer dollars on despite concerns that the diagnostic test at it’s center may not be as accurate as more than a dozen other tests available. Then, as a highly trained public health researcher, I did what we do when our federal and state governments have failed to fund enough actual scientific research … a browser search.
The browser search sent me down a rabbit hole where I found a dark web of private profits, conflicts of interest, a broken regulatory system, and wrong-headed politicians.
Wondering what the title portends to dear reader? Check out the section below titled Wrong-Headed Politicians and see how these governors are making life and death decisions. Then file the information under “You Can’t Make This Shit Up”.
PRIVATE PROFIT
What is TestUtah?
Basically, TestUtah is a consortium of public and private groups that includes Silicon Slopes, Domo, Qualtrics, ATL Technology, Nomi Health, Co-Diagnostics Inc, Salt Lakes Health, RPH Engineering, PROVO Towne Center, OREM, Revere Health, and Mountain Star.
It is an integrated program that identifies who should be tested using an online screening tool, administers the tests in selected locations, processes the tests, and organizes and reports out the data.
This in itself is actually a pretty good model for a public-private partnership to deal with large problems like the pandemic. However, the devil is in the details. Two critical details are the screening tool and the diagnostic test developed, and for TestUtah, these illustrate the dangers that can arise when scientific standards and experts are ignored and companies value quick profits over people’s lives.
How profitable is this?
Despite significant concerns about the accuracy of the test, several states are paying multimillion dollar no-bid contracts using taxpayer money to buy the tests and adapt the system. In addition to Utah, that includes Iowa and Nebraska.
From ‘we pay’ to Utah pays: How pandemic partnership became $5 million-plus contract
What began as a pitch for a coalition of Utah’s tech companies to crowdsource funding to help tackle the coronavirus pandemic in their home state has resulted in multimillion-dollar, no-bid, taxpayer-paid contracts for those companies.
So why did the plan go from “we pay” to the state of Utah pays?
Governor stands by accuracy of TestIowa COVID-19 tests
Reynolds was asked about the tests at her daily news conference after a Salt Lake Tribune story published Thursday questioned their accuracy. A Utah company is contracting with the state of Utah as well as Iowa, which bought tests and equipment from the business earlier this month as part of a $26 million contract.
Ricketts Says TestNebraska COVID-19 Tests Will Be Verified
Nebraska Gov. Pete Ricketts is expressing confidence in the new coronavirus tests that the state purchased through a no-bid contract with a small Utah startup firm after a local newspaper raised questions about the accuracy of the company’s results….
...Ricketts announced last week that Nebraska would pay about $27 million to Nomi Health, a Salt Lake City startup, for 540,000 coronavirus tests in hopes of expanding the state's ability to test residents.
Are there problems with the screening tool?
The Salt Lake Tribune has done an excellent job of uncovering problems related to TestUtah. The first area of concern is the screening tool and an apparent conflict of interest for one of the executives who is part of TestUtah.
Utah tech CEO behind TestUtah showed early interest in malaria drugs
This executive links TestUtah.com and the pharmacy selling the state malaria drugs to treat coronavirus
From the latter article:
The company — Nomi Health
In a rush to make up for testing lags early in the coronavirus pandemic, at least three states, including Utah, have enlisted the Orem company Nomi Health to run statewide websites to screen patients and offer thousands of diagnostic tests.
The screening tool’s questionable question:
The image is from the tribune article and shows a question in the screening tool that asks about allergies to chloroquine and hydroxychloroquine. The question reads, “Do you have any of the following allergies or conditions (select all that apply)?” The first two selections are “I have a Chloroquine Allergy” and “I have a Hydrochloroquine Allergy”.
I have developed numerous surveys and screening tools and this question is garbage for the purpose of the tool. The purpose of the screening tool is to determine whether you are eligible to be tested for the coronavirus, so allergies other than to a cotton swab are irrelevant. Secondly, even if the question was relevant, if you have never taken chloroquine (vast majority of the population), how would you even know? Thirdly, the other choices are conditions also irrelevant to the purpose of the survey, but are related to chloroquine use, i.e not recommended if you have heart rhythm problems or glucose-6 phosphate deficiency, but in low doses, can be a treatment for porphyria.
Why would this question be included in a screening tool to determine whether you should be tested for coronavirus you might ask? Perhaps it’s because, following the screening, TestUtah provides treatment advice, including use of chloroquine or hydroxychloroquine. Of note, recent clinical trials in the U.S. and China have been stopped early because of the high rate of adverse consequences in patients taking the drug, as well as lack of evidence that it is effective against COVID-19. Also, by the way, it is grossly unethical for TestUtah to be giving treatment advice, good or otherwise.
And why would TestUtah want to advise use of chloroquine or hydroxychloroquine?
The executive — Mark Newman (the doses referred to being chloroquine):
And in Utah, Mark Newman, the founder and CEO of Nomi, also serves on the board of directors of the pharmacy that had already has won an $800,000 state contract for 20,000 doses, according to federal documents obtained by The Salt Lake Tribune.
Nothing to see here folks:
Newman on Thursday argued the dual roles — leading a company that is identifying potential patients and helping to steer Meds in Motion, a supplier of the debated treatment — don’t pose a conflict of interest.
Fortunately for the taxpayers of Utah, state officials rethought this purchase.
Those plans were discarded Friday after the U.S. Food and Drug Administration cautioned against administering the unproven medication for coronavirus to patients outside a hospital or clinical trial. Gov. Gary Herbert said the state would not add to its stockpile, and he raised the idea of trying to get its money back for the 20,000 doses Utah already agreed to buy.
And what about Iowa and Nebraska? Is this question in the screening tool they will use? Is there treatment advice in there as well? Bad sign that this may be the case is an excerpt from an article in the Cedar Rapids Gazette:
In the contract between Nomi Health and the state of Iowa, there is a line item stating, “If individuals in the pool test positive and are in high-risk category consider medication treatment (e.g. Hydroxychloroquine or Chloroquine) administered by the Health Department in order to keep hospital bed load low.”
I recommend you read the Gazette article in its entirety. Also, I have asked TestUtah through their chat function about who and how the screening tool was developed. I’m not holding my breath, but will let you know what they say, if I get a response.
Are there problems with the diagnostic test?
The Salt Lake Tribune nails it again.
‘This is a potential public health disaster:' COVID-19 results from TestUtah.com are raising questions
The accuracy of coronavirus tests by TestUtah.com has come into question, with state data showing that the rate of positive results among people tested at its sites is less than half what it is for patients tested elsewhere in the state.
The test developed by Co-Diagnostics is reported to have a lower sensitivity (higher limit of detection) than that of other available tests. This means a higher rate of false negatives in people with low viral loads …. which means many infected individuals are not identified early on ... which means they could unknowingly spread the virus ... which means more cases ... which means more deaths.
From the Little Village Magazine article titled: As Test Iowa finishes its first week, the state is still trying to determine if its tests are accurate
“An analysis by the life sciences publication BioCentury showed that at least 16 of 22 comparable tests authorized by the FDA report a lower limit of detection, or greater sensitivity, than Co-Diagnostic’s tests,” the Tribune said.
A BROKEN REGULATORY SYSTEM
When there is a serious emergency, a balance must be struck between regulatory policies designed to protect people and the time required to approve a product for use. However, not surprisingly, Trump’s FDA has basically thrown those protections completely out the window when it comes to coronavirus tests. So, don’t let anyone tell you that the tests from Co-Diagnostics have been “FDA approved” in the classic sense, as Governor Reynolds falsely implies.
As Test Iowa finishes its first week, the state is still trying to determine if its tests are accurate
The governor was asked on Thursday if she was confident the Test Iowa test kits were as good as kits made by other companies.
“They would have to be, because they were FDA approved,” Reynolds replied.
Classic FDA approval is a very strict process that requires companies to demonstrate that their product (like a drug) is both safe and has equal or greater efficacy then comparable products on the market. If efficacy is only similar to existing drugs, then it must excel in others ways. For example, it must have fewer and/or less severe side effects, lower cost, etc. Thus for final FDA approval, both the human and economic costs are weighed.
The truth for TestUtah is that the FDA, through a rules change, has issued the company making the test an “emergency use” approval. This allows the company to sell the tests despite their failure to meet normal FDA approval guidelines. Apparently, there are FDA officials who don’t understand the importance of a diagnostic test’s sensitivity and the potential consequences of an unacceptably high rate of false negatives. Nor does there appear to be a process whereby “emergency use” approval is revoked should the scientific evidence dictate it advisable. And because the company has no bid contracts with the states, taxpayers will never know whether their dollars could have been better spent. After all, maximum profits must be made before the emergency is over.
WRONG-HEADED POLITICIANS
This is how Governor Reynolds decided to spend $26 million of Iowa’s taxpayer dollars on a system with a questionable screening tool and a subpar diagnostic test. She knows a guy who knows a guy.
How a Utah tech bro came to lead Utah, Iowa and Nebraska's COVID-19 testing
Short version — Governor Reynolds knows Ashton Kutcher who knows Ryan Smith, Qualtrics CEO. Qualtrics is a partner in TestUtah. Mr. Kutcher made the governor aware of TestUtah and she was so “impressed” by their sales pitch, she didn’t feel the need to look at other tests or put out bids.
And how did Governor Ricketts find out about TestUtah:
Ricketts has said the company came up in a conversation with Reynolds, who later told reporters that she was acting on a tip from Iowa-born actor Ashton Kutcher. Ricketts and Reynolds said they also consulted with Utah Gov. Gary Herbert, a fellow Republican who also agreed to work with Nomi Health.
So you might ask, what’s the basic harm here?
In the case of Governor Reynolds, she has consistently ignored facts and public health experts and put lives at risk:
- By refusing to do a statewide shutdown.
- By selecting a test which does not meet CDC guidelines, despite being told of this fact, and in response to advice from individuals with no public health expertise as well as the marketing department of TestUtah.
- By re-opening 77 of 99 counties in the state, despite continued rises in cases and before an effective testing/tracking program is in place.
Governors Herbert and Ricketts through similar actions are also apparently part of the “let’s ignore public health experts in favor of friends and political allies” partnership between Utah, Iowa, Nebraska, and the Trump administration.
These governors have chosen self-serving corporate marketing, personal recommendations and politics over public health experts. The results, for which they will be responsible, will include an increasing number of sick and dying.
Governor Herbert of Utah is up for re-election this year. The next gubernatorial elections in Iowa and Nebraska are in 2022.
Let’s work together to hold these governors responsible for their failures!