An analysis by Columbia University epidemiologists finds more than 36,000 Americans died unnecessarily because government regulators reacted too slowly to the building coronavirus global pandemic in March and April 2020.
During February and March, doctors and public health officials in many states were unable to test patients for SARS-COV-2 because of an extreme scarcity of testing kits caused by bureaucratic snafus in the U.S. Department of Health & Human Services.
On June 10, about three months later, the Centers for Disease Control and Prevention (CDC) announced more than two million U.S. residents were either confirmed to or believed by medical experts to have contracted the disease caused by the SARS-COV-2 virus, known as COVID-19. More than 113,000 Americans have died from COVID-19 or related complications, according to the CDC.
The Columbia University study by epidemiologist Sen Pei uses county-level observations and mathematical models of infection to simulate a counterfactual situation in which government public-health responses began one week earlier than they did.
Had government agencies and lawmakers been able to obtain more data and react more quickly and with more precision, more than 60 percent of the reported infections might not have occurred, the study found.
Swamped by Regulations
The federal government’s process for approving diagnostic tools such as laboratory-developed tests (LDTs) is complex, says Roger Klein, M.D., J.D., a faculty fellow at Arizona State University’s Sandra Day O’Connor Law School, former CDC and U.S. Food and Drug Administration (FDA) advisor, and policy advisor to The Heartland Institute, which publishes Health Care News. FDA clears most lab tests under its “510k process,” however, some tests require the agency’s full approval.
“The only tests that typically are required to go through FDA approval are manufactured tests that are sold and distributed to clinical laboratories,” said Klein. “The other type of tests is laboratory-developed tests, which are tests developed and validated by laboratories for use with their own patients. These include tests created and designed de novo, purchased tests that have been FDA-authorized for sale but are modified or deviate from the label or manufacturer’s exact instructions, and other tests such as tests in Europe that laboratory professionals adapt and validate for use within their laboratories.”
Klein says the process is lengthy when preparation for submission is taken into account and is much more intense for tests that are approved under the highest standard of pre-market approval as opposed to being cleared for use. “The process is document-heavy and involves not only submission but also quality systems regulations—good manufacturing practices—that are poorly-suited for laboratory developed tests.”
“The process is document-heavy and involves not only submission but also quality systems regulations—good manufacturing practices—that are poorly-suited for laboratory-developed tests,” Klein said
Patients Pay the Price
Regulatory dithering is immoral and unethical and costs patients badly, says Jessica Flanagan, the Richard L. Morrill Chair in Ethics and Democratic Values at the University of Richmond.
“First, people are prevented from accessing information about their health status, and that’s harmful because that information may inform their decisions about treatment or resuming work,” Flanagan said. “Second, delays in approval delay public health interventions and prevent officials from learning about the spread of a disease, and that uncertainty also harms everyday people who are trying to manage their risk.”
Says FDA Is Responsible
The FDA is responsible for the causalities inflicted by its failure to approve tests quickly as the pandemic hit, Klein says.
“Early in the COVID-19 epidemic, the FDA’s barriers for laboratories that wanted to deploy LDTs resulted in a critical testing gap,” Klein said. “This experience validated one of the key arguments against FDA regulation of laboratory-developed tests: that labs would be unable to respond quickly to increased medical knowledge and changing conditions such as epidemics.”
Klein says the “testing gap” prevented public health officials and lawmakers from making decisions based on real-world data, and that led to bad policy decisions and unnecessary human suffering.
“Because so few tests were performed, we underestimated the extent of community spread and did not take measures to contain the virus,” said Klein. “We failed to identify infected patients and their contacts, who spread the disease to others. In addition, there was an unrecognized outbreak in a nursing home in Seattle associated with almost 40 deaths that perhaps could have been abated with earlier recognition of the situation.”
Recommends Single Regulator
Klein says Congress should enact the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020, introduced by Sen. Rand Paul (R-KY) in March.
“Sen. Paul is a physician who had coronavirus,” said Klein. “The VITAL Act clarifies that the FDA does not have authority to regulate laboratory-developed tests, which are already regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988 and accompanying regulations,” said Klein. “This would benefit patients and preserve innovation and dynamism in the field and ensure that laboratories can effectively respond to changing conditions or emergencies.”
Calls for Extensive Reform
Flanigan says the government should reform the regulatory system for normal times as well as emergencies.
“As a first step, if there is a health emergency, expedited approval should be automatic,” said Flanigan. “By this I mean that declaring a public health emergency should automatically lower regulatory barriers. Every day of delay sets back public health efforts, so these decisions shouldn’t return to lawmakers and regulators every time there’s a crisis.
“The barriers should not exist in the first place, because everyday nonemergency illnesses can be health emergencies for patients and their families,” Flanigan said. “The same reasons for promoting innovative treatment and fast access during pandemics are more generally reasons for these policies.”
Jesse Hathaway (firstname.lastname@example.org) is a policy advisor for The Heartland Institute.
Sen Pei, Sasikiran Kandula, Jeffrey Shaman, “Differential Effects of Intervention Timing on COVID-19 Spread in the United States”, Columbia University, May 29, 2020:
The Heartland Daily Podcast, March 26, Roger Klein, guest: The Coronavirus Crisis – How testing can be the Holy Grail if Regulators Get out of the Way