How Many Breakthroughs, Really? Feds Probe COVID Biotech; One Medical Under Scrutiny

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

How Many Breakthrough Infections Are There, Really?

COVID-19 Data Dispatch has a roundup of news outlets that have published their own estimates of breakthrough cases, since the CDC isn’t tracking these unless hospitalization or death is involved — and the good news is that breakthrough cases remain low.

An analysis by Bloomberg found 112,000 breakthrough cases from 35 states as of the end of July, while an analysis from NBC News found just over 125,000 breakthrough infections from 38 states.

The Kaiser Family Foundation also reported breakthrough cases from the 24 states that publicly report such data, finding that rates are “well below 1%” in all those states.

COVID-19 Data Dispatch reporter Betsy Ladyzhets wrote that the denominator of 164 million fully vaccinated Americans is important to emphasize with all of these reports, as it shows that breakthrough infections are indeed rare. Breakthrough infections leading to hospitalization or death are even rarer, with only about 6,600 reported by the CDC as of July 26.

Biotech Company Under Federal Investigation Over COVID Drug

CytoDyn, a biotech company based in Vancouver, Washington, has disclosed that it’s under investigation by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ) for the promotion of its investigational COVID-19 drug leronlimab, The Oregonian reported.

In regulatory documents, the company said the SEC is requesting information around its “public statements regarding the use of leronlimab as a potential treatment for COVID-19, and related communications with the [FDA], investors, and others.”

CytoDyn was publicly scolded by the FDA in May, with the agency stating, “it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19,” listing numerous challenges with its two COVID-19 clinical trials.

Company officials told The Oregonian that CytoDyn has been cooperating with federal investigators.

Investors have also filed multiple lawsuits against the company, charging that they were misled by the company’s positive statements on the efficacy of leronlimab — a repurposed investigational agent originally intended for the treatment of HIV — for COVID-19.

Employees Charge One Medical Puts Profits Over Patients

Following reports of attempted unionization, NPR has documented some of the specific allegations that employees have made against One Medical.

NPR interviewed 10 current and three former employees, some of whom — but not all — were part of the unionization effort. These employees painted a portrait of a company that started to put profits over patients following its initial public offering (IPO) in January 2020.

“The minute we went IPO, we pivoted away from patient care to membership volume,” one administrative staffer told NPR. “It’s about membership numbers and showing the investors our membership numbers have gone up.”

Accusations include shortened patient visit times, less time to respond to patient concerns via its call center, and rushed schedules for lab employees.

Patient physicals and preventive care appointments, for instance, went from 40 minutes to 30 minutes, staffers said. They were encouraged to tell patients that shorter visits were part of a “redesigned physical.” The 30-minute visit included 2 minutes for connecting with the patient, 10 minutes for taking patient history, 6 minutes for taking vital signs and other measurements, 6 more minutes for wrapping up the visit, and 5 minutes for walking the patient out and cleaning the room.

One Medical also set targets for the number of calls taken per day at its call center, even though employees previously determined how long calls should be. It also expected staff to be on the phone for 65% of each shift — but duties such as messaging patients online, seeking medication authorization, or following up with billing did not count toward time on the phone.

Finally, One Medical phlebotomists had their morning prep time withdrawn, leaving little time to get equipment ready in the morning as patients were waiting, staffers said.

One Medical denied the allegations and told NPR its focus is on “delivering quality care to our patients.”

The company is also facing external challenges. Earlier this year, it was accused of allowing people with connections to company leadership to jump to the front of the COVID vaccine line. It also was accused of collecting data from non-members around vaccination efforts. These allegations sparked a House subcommittee investigation, and in a recent SEC filing, the company acknowledged being involved in inquiries from the Federal Trade Commission and the California attorney general.

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    Kristina Fiore leads MedPage’s enterprise & investigative reporting team. She’s been a medical journalist for more than a decade and her work has been recognized by Barlett & Steele, AHCJ, SABEW, and others. Send story tips to k.fiore@medpagetoday.com. Follow








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