WASHINGTON – U.S. regulators are moving ahead with a crackdown on scores of antibody tests for the coronavirus that have not yet been shown to work.
The Food and Drug Administration on Thursday published a list of more than two dozen test makers that have failed to file applications to remain on the market or already pulled their products. The agency said in a statement that it expects the tests “will not be marketed or distributed.” It was unclear if any of the companies would face additional penalties.
Most companies faced a deadline earlier this week to file paperwork demonstrating their tests' performance. Regulators required it after previously allowing tests to launch with minimal oversight, which critics said had created a “Wild West” of unregulated testing.
Georgia virus data reportedly flawed
Data on coronavirus infections that was a key driver in Georgia Gov. Brian Kemp's aggressive push to reopen the state was flawed and may have distorted perceptions of progress against the virus.
Georgia Department of Public Health spokeswoman Nancy Nydam said in a statement Thursday that the department included antibody tests when calculating the total number of tests conducted “since early April,” using the same methodology as the Centers for Disease Control and Prevention. She said about 57,000 of the 407,000 total tests reported to the state have been antibody tests.
Conflating the two tests can create confusion about the current impact of the virus, said Dr. Richard Rothenberg, an infectious disease expert at Georgia State University. That's because antibody tests tell you whether a person had the coronavirus in the past, not whether the person was infected at the time of the test.
Kemp defended the state's data gathering in a news conference Thursday afternoon, saying health officials are “taking massive amounts of data from countless sources, putting them into accessible format under a global spotlight, all at breakneck speed.”
Antitrust shield may be invoked
U.S. officials are invoking a rarely used provision of American law that would shield companies from antitrust regulations to help the country from again running out of medical supplies in a pandemic.
The government began formal discussions Thursday with private industry representatives on a cooperative five-year agreement to ensure supplies of protective materials, medical equipment, medicine and vaccines.
The agreement would involve a provision of the Defense Production Act that has been used only twice before to enable competitive businesses and the government to discuss issues of price and supply without running afoul of antitrust regulations, said Joel Doolin, a senior official with the Federal Emergency Management Agency.
Infections not tied to care quality
The Abbott Terrace Health Center in Waterbury, Connecticut, where 41 residents have died from the coronavirus, has been cited by regulators for infection control violations and fined three times by the state and federal governments over the last several years. It has the lowest nursing home overall rating issued by the federal government.
About 40 miles away, the Kimberly Hall North nursing home in Windsor has the highest rating, five stars, issued by the Centers for Medicare & Medicaid Services. It has had one infection control citation, but no state or federal fines, over the past several years. Yet 43 residents there have died from the virus.
Preliminary research indicates the numbers of nursing home residents testing positive for the coronavirus and dying from COVID-19 are linked to location and population density – not care quality ratings – said Vincent Mor, professor of health services policy and practice at Brown University's School of Public Health.
Store barred from radish paste claim
A judge has granted an injunction that prohibits a nutritional supplement store in Los Angeles from billing radish paste as a treatment capable of warding off the novel coronavirus.
The Los Angeles city attorney's office had sued Insan Healing and its founder, Angela K. Oh, alleging she violated state laws that prohibit false advertising. Insan Healing billed its radish paste – a ble nd of “white radish harvested during frost,” garlic and ginger – as an “immunity boost to your lungs” and a “must-have product for the protection and prevention of the COVID-19,” Frank Capetillo, an investigator for the city attorney's office, said in an affidavit filed in court.
The paste costs $99.95 per jar, according to Insan Healing's website, which has since removed all mention of the coronavirus and the infection it causes.