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health

Trump admin. funds plasma company based in owner’s condo

WASHINGTON (AP) — An obscure South Carolina company may be in line for millions of dollars in U.S. government funding to produce a coronavirus treatment after a former Republican senator with a financial stake in the business lobbied senior U.S. government officials.

Plasma Technologies LLC, has received seed money to test a possible COVID-19-fighting blood plasma technology. But as much as $65 million more could be on the way, a windfall for the company that operates out of the founder’s luxury condo, according to internal government records and other documents obtained by The Associated Press.

The story of how a tiny business, which exists only on paper, has managed to snare so much top-level attention is emblematic of the Trump administration’s frenetic response to the coronavirus pandemic.

And it’s another in a series of contracts awarded despite concerns over their proposals voiced by government scientists. The others include an $21 million study of the heartburn drug Pepcid as a COVID therapy, and more than a half-billion dollars to ApiJect Systems America, a startup with an unapproved medicine injection technology and no factory to manufacture the devices. In addition, a government whistleblower claimed that a $1.6 billion vaccine contract to Novavax Inc. was made over objections of scientific staff.

At the center of these deals is Dr. Robert Kadlec, a senior Trump appointee at the Department of the Health and Human Services, who backed the Pepcid, Novavax and ApiJect projects. Records obtained by the AP also describe Kadlec as a key supporter of Plasma Tech, owned by Eugene Zurlo, a former pharmaceutical industry executive and well-connected Republican donor. Three years ago, Zurlo brought Rick Santorum, who spent 12 years as a GOP senator from Pennsylvania, aboard as a part-owner.

Kadlec has come under pressure from the White House to act with more urgency and not be bound by lower-level science officials whom Trump has castigated as the “deep state” and accused of politically motivated delays in fielding COVID-19 vaccines and remedies.


The AP reached out to more than a dozen blood plasma industry leaders and medical experts. Few had heard of Zurlo’s company or its technology for turning human plasma into protein-rich antibody therapies, and would not comment.

Zurlo said in an email that the shortage of plasma from recovered COVID-19 patients, which is needed to make these therapies, underlines the need for the technology he’s patented to harvest as many of these proteins as possible.

In early April, shortly after Congress supplied hundreds of billions of dollars to combat the pandemic, Santorum stepped up his sales pitch for Plasma Technologies and the process the company has described as “disruptive and transformative,” according to the records.

In mid-August, the federal government awarded Plasma Technologies a $750,000 grant to demonstrate that it could deliver on its promises.

HHS would not comment when asked whether Santorum’s public backing of the president helped the company he has a financial stake in getting a government contract.

Santorum told the AP it would have been a

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health

Funds set for EU cross-borders patient transfers

BRUSSELS — The president of the European Commission said it will make 220 million euros available to help EU member states organize the cross-borders transfer of COVID-19 patients.

Speaking Thursday after a video conference of EU’s 27 leaders, Ursula von der Leyen urged European countries to better cooperate in their fight against the deadly virus, which has killed more than 210,000 people across the continent.

Confronted to a massive surge of infections, many EU countries have reintroduced partial lockdowns as they try to avoid reaching a saturation point in their hospitals. Belgium, for instance, has warned the capacity of the country’s intensive care units could be reached in the next two weeks if the pace of new infections is not slowed, meaning patients could need to be transferred abroad.

“If we have more data sharing on ICU capacity, and where capacity is lacking, we can increase the cross-border patient care and it can be organized early enough,” Von der Leyen said. “The good use of the money requires good information exchange.


Von der Leyen also insisted on the necessity of improving the tracing of COVID-19 cases via mobile applications, and to quickly validate at EU level the so-called antigen tests, which are less reliable than the PCR tests but produce results in about 15 minutes.

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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— WHO says Europe has reached 10 million coronavirus cases

— Spain to keep state of emergency until May 2021

— Pope Francis ends general public audiences amid virus surge in Italy

— U.S. public health experts say the nation’s response to the crises has been marked by grave missteps and missed opportunities.

— ‘Difficult winter’: Europe divided on lockdowns as cases soar. EU leaders try to coordinate their approach to virus testing, tracing and vaccines.

— Advertising executive feeds downtrodden Venezuelans from his bicycle seat. Every day, he hands out corn flour patties known as arepas to the hungry.

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— Follow AP’s coronavirus pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

HARTFORD, Conn. — Connecticut has designated more cities and towns as hot zones for COVID-19.

New data released Thursday show about a 70% of residents now live in communities experiencing spikes in coronavirus infections. That prompted Gov. Ned Lamont allow more municipal leaders to revert back to the state’s second phase of reopening where there were more restrictions.

They’re also encouraged to test nursing home staffers. Lamont, a Democrat, acknowledges being dismayed to see the state’s positivity rate climb since Wednesday.

He calls it a “gut punch” for a state that has worked hard to control the spread of the virus.

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MISSION, Kan. — A nursing home where every resident has tested positive for the coronavirus in a rural Kansas county with the state’s highest infection rate has been removed from the Medicare program, putting its funding at risk.

A scathing report from the Centers for Medicare and Medicaid Services cited a lack of masks as

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health

States say they lack federal funds to distribute coronavirus vaccines as CDC tells them to be ready by Nov. 15

State officials have been planning in earnest in recent weeks to get shots into arms even though no one knows which vaccine will be authorized by the Food and Drug Administration, what special storage and handling may be required and how many doses each state will receive.

Despite those uncertainties, the Centers for Disease Control and Prevention is asking states to be prepared to “preposition” doses in key locations throughout the country. Officials want to move quickly once the FDA authorizes a vaccine and a CDC advisory panel issues recommendations on which populations should be vaccinated, according to a letter the CDC sent Monday to state preparedness and immunization officials.

As part of that effort, the CDC is asking states to provide by Tuesday critical information, including a list of each jurisdiction’s top five sites capable of receiving and administering a vaccine that must be stored at ultracold temperatures of minus-70 Celsius (minus-94 Fahrenheit). The letter refers to the vaccine only as Vaccine A, but industry and health officials have identified it as Pfizer’s candidate.

Pfizer chief executive Albert Bourla said Tuesday that “hundreds of thousands” of doses had already been produced and that a first look at the data would occur soon. Pfizer will not apply for any authorization of its vaccine sooner than the third week of November, when it will have sufficient safety data.

“We acknowledge that you are being asked to do unprecedented work,” wrote Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, which is leading the CDC’s role in vaccine distribution. She added: “This is a new planning ask.”

State officials say they have been trying to raise the issue with federal officials but have received little response.

“It is absolutely ridiculous that the administration, after spending $10 billion for a Warp Speed effort to develop a vaccine, has no interest in a similar investment in a Warp Speed campaign to get the vaccine to every American as quickly as possible after it is approved,” said Michael Fraser, executive director of the Association of State and Territorial Health Officials.

Operation Warp Speed is the federal initiative, funded by more than $10 billion of taxpayer money, to fast-track development of coronavirus countermeasures.

“The now accelerated timeline underscores the need to address the issue of funding for state and territorial health agencies to make this all work,” Fraser said. “There are many other costs that have no clear way to be paid for at this point.”

Local officials still need to recruit thousands of people to staff vaccine clinics and enroll and train providers. They also have to ramp up information technology and data systems to track vaccine inventory and ordering to ensure people get the correct doses at the right times — most vaccines will require two shots — and to monitor for adverse events. They will need to develop locally tailored vaccination communications campaigns, too.

“States have received some funding, but it’s not nearly enough” to support the scale, scope and

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health

Some Hospitals Giving Back CARES Act Funds

Several hospitals and healthcare systems have “returned” CARES Act funding, according to reports and a federal database, though it’s not clear whether those funds were repaid or given back without being spent.

An analysis by MedPage Today also revealed discrepancies in public statements and reported distributions by some of the nations’ top healthcare systems.

HCA Healthcare, the for-profit hospital system based in Nashville, Tenn., said in a press release earlier this month that it would “return, or repay early,” its entire $1.6 billion in CARES Act distributions along with $4.4 billion in Medicare accelerated payments. Leadership determined the company didn’t need the money after netting a $1.1 billion profit for the second quarter, according to the press release.

But HCA’s COVID Stimulus Watch page, produced by watchdog Good Jobs First, indicates the company actually received $1.57 billion from general distributions — loans that are often tied to Medicare accelerated payments — plus $487 million in targeted grants.

That $2.1 billion total, derived from multiple data sources including Department of Health and Human Services (HHS) data, is well short of the $6 billion HCA noted in its press release.

In addition, the HHS database has recorded only about $141.5 million accepted by HCA entities via general CARES Act distributions, as of Tuesday. An an HHS spokesperson said its dataset “only includes payment amounts formally accepted by providers.”

Researchers at Good Jobs First told MedPage Today that what public companies report publicly regarding CARES Act funds sometimes does not match HHS data. That has been the case with Tenet Healthcare and HCA, researcher director Philip Mattera said.

“HCA was not very clear in that announcement [the news release] about what exactly they are giving back or returning,” Mattera said.

An HCA spokesperson said he was unfamiliar with the COVID Stimulus Watch database and declined further comment for this story, repeatedly pointing to the news release to answer questions.

The American Hospital Association and the Federation of American Hospitals also declined to comment for this story.

The Provider Relief Fund, established under the CARES Act, involves both general distribution loans (which often include Medicare advance payments) and targeted grants for medical centers deemed to be most needy. But some Medicare funds are included in both categories and general distribution figures keep changing because they are based in part on providers completing forms, Mattera said.

“All of this makes it tough to pin down exact numbers,” Mattera said.

Similar discrepancies were seen with Kaiser Permanente. The health system said it declined most of the more than $500 million it was eligible to receive, according to a spokesperson and a news release. Both sources noted Kaiser Permanente “declined all of [the money] except for $11.8 million for Maui Health System, a nonprofit subsidiary of Kaiser Foundation Hospitals.”

But Maui Health System actually received $17.2 million, according to the HHS general distribution database.

“Bottom line: we did not accept or keep any of [the $500 million-plus] except the money for Maui Health System,” the Kaiser Permanente

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