Ethical Questions Still Surround Hays County Judge’s COVID-19 Testing Kits

Melissa Jewett, Publisher

Two weeks ago, Hays County Judge Ruben Becerra purchased 2,000 Coronavirus testing kits to be used by the county health department without the knowledge or approval of the rest of the commissioners’ court, and ethical questions are surrounding this controversy.

In a joint press conference with Hays County Judge, Kyle Hayungs, MRG Medical, and Dr. Henry Legere, CEO of Reliant Immune Diagnostics, announced new COVID-19 testing kits would be available for purchase online through HEB with doctor authorization.

A video of this press conference was posted to the judge’s YouTube and Facebook accounts; however, those videos have since been deleted.

When he announced the purchase, Becerra said priority would be given to first responders, health care professionals, and those experiencing symptoms. 

Now a Hays County woman is seeking answers after spending $50 to go through the process with the Austin-based telemedicine company for an “at-home COVID-19 testing kit.”

According to a report by KVUE, Linda Krolczyk signed up for MDBox’s telemedicine service following the company’s announcement that Hays County residents would be able to get “at-home testing kits” for the disease.

However, Krolczyk has never received the test from MDBox and is asking questions after the company told her she’d have to go to a testing site to get one.

But Krolczyk is not the only Hays County resident asking questions.

There have been many questions submitted to Becerra on social media from his constituents since the original announcement. However, the judge replied and stated he “did not have time to reply to questions and concerns individually at present.”

Becerra said he expects to release another video update with doctors that explains everything.

In his latest update, Becerra identified local sites and facilities where residents can be tested for COVID-19 with doctor authorization. Residents can use insurance, which may come with a copay, or pay a flat $50 fee to receive testing.

Residents are asked to call ahead and make an appointment unless it’s an emergency; doctor authorization is still required.

The telemedicine company states on its website it is offering free service to Hays County residents to monitor their symptoms.

But patients are required to pay a fee in order to move forward and seek testing. 

The company later retracted earlier statements about where people could purchase the tests after HEB released a statement denying that the company would be selling the kits through its website.

Additionally, an HEB spokesperson stated they had been in discussions with MDBox, but had no contract or agreement with MDBox and will not be working with them in the future.

MDBox officials released an updated statement saying the tests would be available for purchase with doctor authorization through their website until further notice.

While the tests could be performed at home, they do require physician supervision and direction to administer as well as read the results.

However, now, according to their website, they are working with community leaders and partners to deploy COVID-19 testing and diagnosing pop-up clinics in Hays County.

The serology tests will be administered by medical professionals to qualifying individuals.

The testing kits are among several that have been waived but not approved by the FDA. Unlike those currently being used around the world for COVID-19 diagnosis, the tests use a small blood sample to check for COVID-19 antibodies.

Dr. Deborah L. Birx, M.D., of the White House Coronavirus Task Force, said Tuesday that serology tests (antibody tests) were faulty and warned Americans “do NOT buy any antibody tests online.”

Serology tests are designed to detect antibodies of diseases through blood samples from those who have been exposed and/or are possibly immune to a virus or disease.

Hays County Epidemiologist, Eric Schneider, during April 7’s Commissioner’s Court meeting and said health officials are still in discussion on the use of antibody tests for identifying COVID-19. 

“More than likely, that is not going to be something that constitutes a confirmed case,” Schneider said. “The serology test that is done is a great way to check to see if you have had a past disease.”

Schneider said healthcare professionals use the tests to provide proof they’ve been vaccinated for things like measles, mumps, and others if they cannot find their childhood shot records.

“It tells you if you’ve had it before,” Schneider said. “It is not a great tool for measuring active cases.”

The Food and Drug Administration approved the first rapid coronavirus blood test on March 24. Still, the test has a one in three probability of getting it right.

Birx is asking Americans to wait until the antibody tests have been approved by the FDA and are 96 percent or more accurate.

In a report by Bloomberg on March 31, many European leaders purchased similar tests from China as COVID-19 started to spread through the continent and are now regretting it.

While the tests are required to be simple and have a low risk for erroneous results, it does not mean they are completely error-proof.

Becerra has refused to answer questions on the partnership between MDBox and himself on behalf of Hays County, so little is known about it.

During Corridor News’ investigation, several photographs were found of Becerra and Alex Villalobos, Hays County Chief of Staff, with Kyle Hayungs, founder of MRG Medical. The photos are dated back to December 2018.

MRG Medical is a medical marketing company that has partnered with MDBox as part of a COVID-19 Taskforce.

According to comments and photos posted, Hayungs is supporting Villalobos’ campaign for Hays County Sheriff.

Becerra has not released a statement or an announcement about whether Hays County still intends to use the 2000 testing kits he purchased or how or who paid for the tests.  

But the Hays County Commissioners are slated this week to discuss the purchase and distribution of COVID-19 tests and other products and services related to COVID-19 according to the agenda.

“On April 8, 2020, regularly-scheduled conference call of mayors, city managers & other essential staff, we were informed that Hays County has been purchasing COVID-19 tests,” the agenda states. 

The discussion will determine what vendor the county will purchase the tests from and where and how they will be distributed.

Typically, in Texas, a county judge is granted the authority to sign for something on behalf of the county by Commissioners’ court.

The process involves an agenda item with a resolution naming the judge as the appointed signee of purchase agreements or contracts on the county and court’s behalf.

However, no formal agreement came across the dais before Becerra’s announcement. It’s possible the purchase may have been made with the judge’s personal funds, which he may be able to be reimbursed for later.

The Commissioners Court received three documents from health professionals last week advising against the use of the tests purchased from MDBox. 

A letter from Medical Directors Kate Remick, MD, of San Marcos — Hays County EMS, Ory Barak, MD, of Buda Fire and EMS, and Steven Moore, MD, of Wimberley EMS to the court provided their input on the MDBox telemedicine service and serology tests.

Dr. Remick, Dr. Barak, and Dr. Moore followed up on April 6 with a memorandum highlighting their concerns.

The concerns are listed below. 

  • The test evaluates immune response (IgM/IgG antibodies) only and not the virus itself

  • The test (Guangzhou Wondfo Biotech Co., Ltd. SARS-CoV-2 Antibody Test) is not FDA approved

  • The test is not specific for SARS-CoV-2 virus antibodies and requires confirmatory molecular testing

  • The test does not detect viral “shedding”

  • The test does not detect the virus in the early stages of COVID-19 disease

  • CDC guidelines for testing do not include SARS-CoV-2 IgM/IgG testing

  • The test has a fee

“Although a clear role for the test may eventually emerge, at present, there is minimal medical guidance on how antibody tests should be used in response to the COVID-19 pandemic,” the memorandum stated. “For now, we feel Hays County is responding appropriately to the COVID-19 pandemic and maintains sufficient testing capabilities for SARS-CoV-2.”

“Additional testing using the Guangzhou Wondfo Biotech SARS-CoV-2 testing in conjunction with the MDBox platform, as described by the manufacturer, will not provide sufficient additional information needed to assess the prevalence and/or risk of ongoing COVID-19 exposure in Hays County,” the medical directors concluded. 

Texas Senator Donna Campbell, M.D., also sent the court a letter advising them to proceed with caution regarding the virus and the use of unauthorized, fraudulent COVID-19 test kits. 

“The best intentions can lead to unfortunate unintended consequences,” Senator Campbell said. 

Photographs and PDF versions of the letters and memo are viewable below.

 

 

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Memorandum COVID-19 Antibody Testing 4-6-20
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