**This story has been updated to include comment from researcher Christopher Mason and to clarify information about the effects of heating coronaviruses.
Empower Wisconsin | Sept 15, 2020
MADISON — The City of Racine City Hall Annex has been transformed into a laboratory where city employees work with a highly contagious virus that has killed nearly 200,000 people in the U.S. — more than 1,200 in Wisconsin.
And Racine city officials don’t seem at all concerned about the potential safety and liability hazards.
Sources with backgrounds in biotech tell Empower Wisconsin city leaders and Racine citizens should be very wary of the dangers of a COVID-19 experiment they say has no business being conducted on city property.
In July, mainstream media outlets began doing feature stories on Christopher Mason’s research. Mason, associate professor and systems biology wunderkind at Weill Cornell Medicine, is looking for a faster way to test for COVID-19. Mason also just happens to be the brother of Racine’s liberal Mayor Cory Mason, a fact that raises some conflict of interest questions. The scientist, the stories note, came home to turn his hometown into a cutting edge laboratory in the fight against a relentless and deadly pandemic.
Professor Mason is working alongside Alison Kriegel, PhD, associate professor at the Medical College of Wisconsin.
As Fox6 explained in late July, the researchers established a mobile lab in the Racine City Hall Annex. They have employed city firefighters to collect “a few milliliters of saliva from city employees taking part in the study.”
“We’re cooking the saliva at 95 degrees for 30 minutes to essentially kill the virus. And then from there, we’re testing it,” Chief Brian Wolf of the Racine Police Department, told the news outlet.
The idea, officials say, is to limit the chance for spread within the lab.
But is a city building where several departments are located — parks and recreation, water and wastewater among them — the best place to research a test for a virus that is considered at a risk level below Ebola?
The Centers for Disease Control and Prevention has advised that SARS-COV-2, the coronavirus that causes COVID-19 “should be isolated and studied only in laboratories with advanced containment capabilities, meaning those with a biosafety level (BSL) of 3 or higher.”
So they are conducting a test on a virus that is considered at a risk level below Ebola. Organisms are classified on a Biosafety scale of 1 to 4 — 1 being fairly safe, 4 being, well, the deadly Ebola virus.
In an email response to Empower Wisconsin, Kriegel insists the lab is “not working with live virus.” She said samples are collected in a tube by subjects, capped and then “heat activated” in the closed collection container to kill the virus prior to handling.
A biotech expert who spoke to Empower Wisconsin on condition of anonymity said Kriegel’s explanation is absurd.
“So they aren’t working with the live virus. They are just collecting samples and heating them to, well, kill the live virus,” the source said. “Even accepting such an absurd statement, there is no published guideline for that treatment killing the virus.”
Studies show heat over certain durations can destroy coronaviruses, but there are variables, as the Centers for Disease Control and Prevention notes in a July summary of studies.
“Generally coronaviruses survive for shorter periods at higher temperatures and higher humidity than in cooler or dryer environments. However, we don’t have direct data for this virus, nor do we have direct data for a temperature‐based cutoff for inactivation at this point. The necessary temperature would also be based on the materials of the surface, the environment, etc.,” the CDC summary notes.
What if a tube containing samples cracks or shatters? Maybe it’s dropped during heating. The biotech expert who spoke to Empower Wisconsin said an aerosol will immediately form.
“This could enter the building ventilation system and contaminate work surfaces and the floors,” the source said. How are workers and the public being protected?
Professor Mason acknowledged the potential risks.
“In terms of the safety question, there’s always a chance you don’t collect a sample right … nothing is 100 percent risk-free,” he said. “But once it’s in the tube and you cap it and heat it, to my knowledge, there’s not a single piece of information that says the virus is still effective.” If so, the researcher added, ” you could just heat it longer.”
Not to worry, Kriegel says. “Everyone is wearing full PPE (personal protective equipment) and disposables were being treated as biohazardous waste.” That means the waste has been autoclaved and/or collected for biohazard disposal through the private company the health department uses, the researcher said.
She said first responders assisting in the research have received HAZMAT training. Besides, she added, they’re already at risk of encountering infected people while in the normal course of their public safety duties.
“Employees being tested (and it is only City employees being tested, who volunteer to participate in the study) are already (potentially) breathing into ventilation systems, using restrooms and touching surfaces in city buildings—as is everyone every time we go out in public,” Kriegel said.
That’s an interesting position to take, however, in a city run by Professor Mason’s brother — the mayor — who, alongside city council members, has done everything in his power (and outside of his power) to lock down or limit businesses and the liberties of citizens to save them from COVID-19.
Ethics and liability
The ethical use of human subjects, as in the Racine annex COVID test research, requires a thorough review by an established Institutional Review Board (IRB), according to federal regulations. The history of contemporary human subjects protections began in 1947 with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis, according to the federal Office for Human Research Protections.
Kriegel said the Medical College of Wisconsin’s IRB approved the COVID-19 test study, but she said she does not know which members in particular were involved. It would be inappropriate, the researcher said, for her to know the names of the board members or identify them.
The research would seem to raise myriad liability concerns for the city of Racine and its taxpayers.
City Attorney Scott Letteney said “direct funding” for the research project is coming from Cornell, while the Medical Center of Wisconsin is paying for the cost of its employees’ participation — in wages/benefits — for participation in the COVID-19 test experiments. Letteney said employees are covered under Racine’s workers compensation coverage.
Is the city indemnified in case of a an accident?
The city attorney said the question is “very nonspecific,” but added there are “liability-limiting provisions in the agreement and in the law.” He did not specify what the liability-limiting provisions are.
And what about employees’ Health Insurance Portability and Accountability Act (HIPAA) rights? Are they being protected? Letteney claims there is no “HIPPA effect.”
“All screening, diagnostic, and any other health information is under the control of the research scientists. No screening, diagnostic, or any other health information about employees tested is being share(d) with the City of Racine as an employer,” the city attorney said.
Will Racine’s taxpayers benefit from the proceeds of a successful and marketable COVID-19 rapid test? Will they be rewarded for their risk? Does Cory Mason stand to profit from his brother’s research on taxpayer time? The mayor did not respond to Empower Wisconsin’s request for comment.
The researchers see big things for their test, and they told Fox6 that they would move forward as fast as they could to “try to validate this test.”
“…(H)opefully, we’ll be able to open it up to a broader community once we are able to get the validation completed, Kriegel said.
But have the researchers put lives on the line in their rapid quest for a rapid COVID-19 test built on cozy political relationships?