Government Coronavirus Response: A Series of Missteps
[Analysis by David McFarland] Missteps by federal agencies and the Trump Administration grappling with the coronavirus outbreak will no doubt make a nice “lessons learned“ case study one day on what not to do the next time the U.S. faces a pandemic.
Because we at FDA Webview tend to focus on FDA happenings, let’s begin by trying to understand how the agency was officially kept off the HHS-led coronavirus effort until two days ago, when the White House announced that its own commissioner, Stephen Hahn, along with Housing and Urban Development secretary Ben Carson had been added as an apparent afterthought. Before even questioning why the Housing secretary was added at all, it might be remembered that he is a medical doctor – but why was Treasury secretary Steven Mnuchin and economic advisor Larry Kudlow added to the task force well before Hahn?
The debacle around delayed and defective diagnostic testing being handled by the CDC has many questioning why FDA did not play a more prominent role as matters got worse. According to Politico, as concerns grew last month over why CDC-manufactured test kits were not working as intended and subsequent delays in shipping kits to public health laboratories prevented surveillance testing, CDRH Office of In Vitro Diagnostics director Timothy Stenzel was dispatched to CDC’s Atlanta manufacturing facility to lend a hand. However, after arriving at CDC’s campus as expected, officials there stalled his access until the next day. We are sure there are a few in regulated industry wondering just how much trouble they would be in if FDA came knocking on the door and their admittance was refused. A CDC spokesperson said that the delay was due to a scheduling misunderstanding.
Once inside, Stenzel found evidence of lab contamination, which he reported to HHS officials, and this may have contributed to the coronavirus lab-test delays and other problems, according to Politico. “Contamination is one possible explanation but there are others, and I can’t comment on what is an ongoing investigation,” CDC’s National Center for Immunization and Respiratory Diseases Nancy Messonnier told reporters recently. HHS has begun an investigation into the lab-test defect and potential contamination.
Throughout the lab tests delay, government officials appeared not to have a plan B. Other labs across the U.S. that have expertise in developing their own tests were kept needlessly idle and without access to reference materials and FDA authorizations. A month ago (2/4), former FDA commissioner Scott Gottlieb wrote an opinion piece in the Wall Street Journal complaining about only the CDC having the capability to run virus testing. “Private test developers need clearance from the Food and Drug Administration to distribute or use tests,” he said. “But that will take some time. Developers need access to samples to be sure their tests are reliable, and companies have to submit paperwork for FDA review.”
Despite the testing problems, it took FDA and CDC almost a month to agree that private test developers need to be given the green light to get their testing up and running to substantially increase testing capacity. On 2/29, FDA announced a new policy to permit certain laboratories to use tests they develop and validate (see story). The new FDA policy permits certain laboratories to use validated diagnostics before the agency has completed the review of their Emergency Use Authorization requests.
Now let’s get to the whole issue of transparency and public communications from the Trump administration and its agencies. The public needs facts and the truth to have confidence in what they are being told. Testing was a mess and the delays have prevented affected communities knowing how widespread the outbreak may be.
Now that private labs are getting involved, in addition to new test kits being distributed to the designated public health laboratories, Hahn has said that the testing capacity should be at one million by the end of the week. However, experts are scratching their heads wondering how this could be, putting testing levels at a fraction of what the public is being told.
On “Face the Nation” 3/1, Gottlieb said that is likely that only 10,000 people a day could be tested by the end of the week if all 100 public health labs were up and running. If the lab-developed tests that FDA green lighted 2/29 ramp up, the country's total capacity could increase by an additional 10,000 tests per day within two weeks, he said. Politico has reported similar concerns by testing experts.
On 3/3, a White House press briefing by the coronavirus task force saw Hahn elaborating further about the testing capacity. He said additional tests are being manufactured by Integrated DNA Technologies. “They’re working with CDC to increase the capacity of the CDC-developed test,” he said. “They’re giving those tests to CDC to further disseminate to the public health laboratories. They are also receiving orders from around the country — academic healthcare institutions, big hospitals, as well as commercial laboratories around the country — to further disseminate that test. Their estimate is that, by the end of this week, they will be able to have shipped one million tests to these non-public health laboratories. In subsequent weeks, they expect to escalate even further their manufacturing to higher numbers than that.”
To make matters even less transparent, CDC recently removed a daily tally from its Web site that showed the total tests performed on suspected coronavirus infections. On Monday, Rep. Mark Pocan (D-WI) wrote a letter to the agency demanding to know “why their Web site removed public data on the number of patients tested in the United States.” Messonnier recently told reporters that CDC stopped sharing data on the testing because of the increasing testing at the state level. “We are no longer reporting the number of persons under investigation or those who tested negative,” she said. "With more and more testing done at states, these numbers would not be representative of the testing being done nationally.”