Timothy Stenzel, the director for the FDA’s Office of In Vitro Diagnostics and Radiological Health, was forced to wait overnight over the weekend of February 22 to get on the premises. Although his visit was reportedly expected, senior health officials were forced to negotiate his access through a series of phone calls before the CDC would allow him to step foot on their campus.
Stenzel, a diagnostics expert and respected scientist, had been sent by the FDA to try to help the CDC speed up the development of novel coronavirus lab tests. The CDC-developed test has run into problems that have delayed plans by the Trump administration to expand screening for the highly contagious illness.
These delays have prevented Americans who don’t fit into the strict criteria set by the CDC from getting tested for the disease. At first, the CDC was only allowing those who had recently visited China or had been in close contact with a confirmed case and also displayed symptoms to get the test.
According to Politico, a senior official with the Department for Health and Human Services (HHS) has confirmed the episode in question took place.
The CDC had been going out of its way to reassure HHS leaders the lab tests were forthcoming. The group claims the delay was simply a scheduling misunderstanding, but skepticism abounds.
Their spokesperson said that Stenzel arrived at the campus at 7pm on February 22, which was a day before they had been expecting him. They blamed his denied access on security issues before adding that he was admitted on the following morning and escorted on campus by CDC staff.
During the visit, Stenzel uncovered evidence of lab contamination and reported it to HHS officials. It’s believed this may have played a part in the delays of coronavirus lab tests and other issues surrounding testing.
Sources told Axios that Stenzel was “alarmed” by some of the procedures he saw at the Atlanta lab and mentioned his concerns to several officials with the CDC.
So far, hundreds of coronavirus cases are being reported across the country, and evidence points to the virus spreading throughout the nation for weeks undetected.
CDC admits "flaws" in tests
For its part, the CDC has admitted that their lab tests had “flaws” that were getting in the way of the health department’s plan to expand testing in the U.S., but they were predictably vague when discussing it.
The director of the CDC's National Center for Immunization and Respiratory Diseases, Nancy Messonnier, said in a conference call that “Contamination is one possible explanation but there are others, and I can’t comment on what is an ongoing investigation.”
The HHS has asked a team of scientists from outside the CDC to look into the defects in the lab test. They’ve also launched an investigation into the coronavirus tests’ potential contamination.
It’s hard to say how many lives could potentially have been saved had the CDC granted access more urgently to the man sent to help them at a critical time – or had they actually had their act together and avoided contamination and delays in their lab tests in the first place.
Needless to say, moving a little faster in this situation could have helped with early detection of the virus and potentially diminished its spread.
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