番茄社区

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

China Kept WHO in the Dark

While the World Health Organization (WHO) was publicly praising China in January for its response to the novel coronavirus outbreak, behind closed doors the agency was frustrated that it wasn't getting the information it needed, .

Recordings obtained by the AP suggest that WHO officials were paying lip service to China in an attempt to get the country to divulge more information.

Those recordings, as well as other interviews and internal documents, show that China sat on information about the viral genome and stalled the release of detailed patient data, which could have slowed the pandemic in those early days, experts said.

The first Chinese lab to identify the new virus did so on Dec. 27, 2019, with others soon following. But the following week, the National Health Commission ordered labs with the virus to destroy samples or send them to certain institutions. It also forbade labs from publishing about the virus without government approval.

Two days later, a famous Chinese virologist warned officials that the virus was likely "contagious through respiratory passages" and recommended "taking preventative measures in public areas."

It took a to get Chinese officials to announce the discovery of the virus, but they still didn't release the genome or detailed patient data. Three days later, the well-known virologist published the sequence on -- and his lab was subsequently shuttered by health authorities, albeit temporarily.

That finally prompted key Chinese agencies to publish the sequence on Jan. 12 on , and 2 days later in a confidential teleconference, China's top health official told the country to prepare for a pandemic. Publicly, however, those officials were still saying the risk of human-to-human transmission was low, according to the AP.

It wasn't until Jan. 29 -- after WHO officials met with President Xi Jinping in Beijing -- that the agency finally declared a public health emergency based on additional information.

The AP noted that the WHO has no enforcement authority, so it has to rely on the compliance of its members, and it was concerned that it would have been kicked out of China if it pushed too hard.

Last week, President Donald Trump said he would withdraw U.S. funding and support of the WHO, charging that the agency colluded with China to cover up the crisis; but the AP's reporting suggests the WHO was similarly kept in the dark.

Secret Russian Ventilator Shipment

The White House accepted a shipment of ventilators from Russia but never told the FDA, preventing any type of regulatory oversight,

Instead, the FDA learned about the shipment of 45 Aventa-M ventilators from the Federal Emergency Management Agency (FEMA) just a day before it landed in the U.S. on April 1.

The agency has issued Emergency Use Authorization to other ventilator models, but never had the opportunity to do so for the Russian ventilators, according to Reuters.

Earlier this month, Russia suspended the use of some of the Aventa-M ventilators after six people that allegedly involved the devices.

"It is troubling that potentially unsafe medical devices were able to enter the U.S. apparently with minimal or no formal regulatory review," Rep. Frank Pallone, Jr., (D-N.J.), chair of the House committee that oversees the FDA, told Reuters in a statement.

The shipment was originally intended to help New York and New Jersey, but neither state ended up using them. They were never distributed as they required an electrical voltage that's not compatible with U.S. standards, and are being returned to FEMA.

FDA Chief Helps 'Country Doctor' Get HCQ

The Commissioner of the FDA took time out of his busy schedule in the midst of the COVID-19 outbreak to reach out to an obscure family physician in upstate New York to discuss a hydroxychloroquine (HCQ) trial, .

Stephen Hahn, MD, had never before been in touch with Vladimir Zelenko, MD, a 46-year-old self-described "country doctor" who said he had been prescribing HCQ plus azithromycin and zinc to COVID-19 patients early in the disease with much success.

In a series of text messages obtained by Vanity Fair, Zelenko asked Hahn for help in setting up a clinical trial of the three-drug combination in 750 outpatients at St. Francis Hospital in Roslyn, New York.

After asking about institutional review board approval, Hahn told Zelenko to reach out to FEMA to obtain HCQ from the national stockpile. When Zelenko said he wasn't sure how to proceed, Hahn replied: "I'll send you the contact."

Hahn also introduced Zelenko to the director of the National Library of Medicine, Patricia Flatley Brennan, RN, PhD, who suggested he write a case report for publication.

"That is way outside what one would consider normal for a commissioner to do," an official from the Department of Health and Human Services told Vanity Fair, regarding Hahn's intervention to help a single hospital obtain pharmaceuticals. "I have never heard of anyone at FDA doing anything like that."

It appears the Trump administration discovered Zelenko via a YouTube video the doctor had posted discussing the good results he'd seen with HCQ in his COVID-19 patients. Trump's chief-of-staff Mark Meadows subsequently reached out to Zelenko to ask for patient data, according to Vanity Fair.

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