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Sunday, August 1, 2021

COVID-19 vaccine response in people with multiple sclerosis

 Emma C Tallantyre, Nicola Vickaryous, Valerie Anderson, Aliye Nazli Asardag, David Baker, Jonathan P Bestwick, Kathryn Bramhall, Randy Chance, Nikos Evangelou, Katila George, Gavin Giovannoni, Leanne Grant, Katharine E Harding, Aimee Hibbert, Gillian Ingram, Meleri Jones, Angray S Kang, Samantha Loveless, Stuart Moat, Neil P Robertson, 

Klaus SchmiererSitash Navin ShahJessica SimmonsMatthew UpcottMark D WillisStephen JollesRuth Dobson

Risk factors for severity of COVID-19 in hospital patients age 18–29 years

 




PDF: https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0255544&type=printable

Abstract

Background

Since February 2020, over 2.5 million Texans have been diagnosed with COVID-19, and 20% are young adults at risk for SARS-CoV-2 exposure at work, academic, and social settings. This study investigated demographic and clinical risk factors for severe disease and readmission among young adults 18–29 years old, who were diagnosed at a hospital encounter in Houston, Texas, USA.

Methods and findings

A retrospective registry-based chart review was conducted investigating demographic and clinical risk factors for severe COVID-19 among patients aged 18–29 with positive SARS-CoV-2 tests within a large metropolitan healthcare system in Houston, Texas, USA. In the cohort of 1,853 young adult patients diagnosed with COVID-19 infection at a hospital encounter, including 226 pregnant women, 1,438 (78%) scored 0 on the Charlson Comorbidity Index, and 833 (45%) were obese (≥30 kg/m2). Within 30 days of their diagnostic encounter, 316 (17%) patients were diagnosed with pneumonia, 148 (8%) received other severe disease diagnoses, and 268 (14%) returned to the hospital after being discharged home. In multivariable logistic regression analyses, increasing age (adjusted odds ratio [aOR] 1.1, 95% confidence interval [CI] 1.1–1.2, p<0.001), male gender (aOR 1.8, 95% CI 1.2–2.7, p = 0.002), Hispanic ethnicity (aOR 1.9, 95% CI 1.2–3.1, p = 0.01), obesity (3.1, 95% CI 1.9–5.1, p<0.001), asthma history (aOR 2.3, 95% CI 1.3–4.0, p = 0.003), congestive heart failure (aOR 6.0, 95% CI 1.5–25.1, p = 0.01), cerebrovascular disease (aOR 4.9, 95% CI 1.7–14.7, p = 0.004), and diabetes (aOR 3.4, 95% CI 1.9–6.2, p<0.001) were predictive of severe disease diagnoses within 30 days. Non-Hispanic Black race (aOR 1.6, 95% CI 1.0–2.4, p = 0.04), obesity (aOR 1.7, 95% CI 1.0–2.9, p = 0.046), asthma history (aOR 1.7, 95% CI 1.0–2.7, p = 0.03), myocardial infarction history (aOR 6.2, 95% CI 1.7–23.3, p = 0.01), and household exposure (aOR 1.5, 95% CI 1.1–2.2, p = 0.02) were predictive of 30-day readmission.

Conclusions

This investigation demonstrated the significant risk of severe disease and readmission among young adult populations, especially marginalized communities and people with comorbidities, including obesity, asthma, cardiovascular disease, and diabetes. Health authorities must emphasize COVID-19 awareness and prevention in young adults and continue investigating risk factors for severe disease, readmission and long-term sequalae.

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255544






Britain to Offer Vaccine Booster Shots for 32 Million Next Month

Britain will offer COVID-19 booster vaccines to 32 million Britons starting early next month with up to 2,000 pharmacies set to deliver the programme, The Telegraph reported https://bit.ly/37dhYIl on Sunday.

The campaign could start as soon as Sept. 6, which would see the rollout completed by early December if it goes to plan, the report added.

https://www.usnews.com/news/world/articles/2021-08-01/britain-to-offer-vaccine-booster-shots-for-32-million-next-month-the-telegraph

Dexcom Jumps As Q2 Earnings Beats Street, Raises Guidance; Target Bumped Up

 Continuous glucose monitor developer Dexcom Inc (NASDAQ: DXCM) shares ticked up as second-quarter results easily topped the consensus forecast; adjusted EPS of 0.76 beat the consensus of $0.45.

Sales increased 32% Y/Y $595.1 million, well ahead of the estimate of $551.3 million. Dexcom's biggest storyline is the expected launch of its next-generation G7 device. It has filed for the European CE mark and expects a European launch later this year, but news has been quiet regarding FDA approval and a U.S. launch.

Outlook: Based on its strong second quarter, Dexcom said it is increasing its guidance for 2021: It expects revenue of $2.35 billion - $2.4 billion.

Analyst Take on Earnings: Piper Sandler raised the price target to $550 from $500, with an Overweight rating unchanged.

The new guidance range is "readily beatable," assuming that the delta variant is not too impactful, says analyst Matt O'Brien.

Baird increased the price target to $520 from $460 and an Outperform rating.

The analyst remains bullish, and the company has moved up a few notches on "the best growth story in MedTech" list.


The price target at Stephens also increased to $546 from $468, with an Overweight rating as he raised his 2021 and 2022 estimates.

Oppenheimer too beefed up the price target to $525 from $500, and Outperform rating unchanged.

SVB Leerink also increased the price target to $500 from $485. DexCom doubled the prescribing physician base and delivered nearly 18% global sequential sales growth, nearly 2x faster than competitor Abbott's Libre, says the analyst.

Canaccord moved the price target higher to $500 from $455 and kept a Buy rating.

Raymond James moved the target higher to $515 from $466 and kept an Outperform, saying Dexcom "not only cleared the bar but also did so with some flair."

https://finance.yahoo.com/news/dexcom-stock-jumps-q2-earnings-172337547.html

53 health systems requiring mandatory COVID-19 vaccines for their workforces

 With cases spiking across the country, top health officials are making it clear that COVID-19 is becoming “a pandemic of the unvaccinated.”

According to the CDC, less than half of the total U.S. population has been fully vaccinated and yet fewer Americans are lining up for shots each week.

Hospitals and health systems, which have borne the brunt of the pandemic, are now starting to look inward at the vaccination rates of their own workforces. A growing number of providers are shifting their policies away from simply encouraging staff vaccination to requiring the shots as a condition of employment.

While this hard line has drawn protests and lawsuits from unvaccinated employees who say the requirements infringe on personal freedoms, mandatory COVID-19 vaccination policies have picked up the support of numerous professional and industry organizations.

“COVID-19 vaccines protect healthcare personnel when working both in healthcare facilities and in the community. They provide strong protection against workers unintentionally carrying the disease to work and spreading it to patients and peers,” the American Hospital Association (AHA) said in a July 21 policy statement. “The AHA … supports hospitals and health systems that adopt mandatory COVID-19 vaccination policies for healthcare personnel, with local factors and circumstances shaping whether and how these policies are implemented.”


Organizations that have taken the leap include major names like Trinity HealthBanner HealthAtrium Health and the Veterans Health Administration. Across the board, the policies of these and other providers include exemptions for medical, religious or other legally protected reasons.

At the same time, some health systems that are encouraging staff to vaccinate are holding back on making it a hard requirement.

Ballad Health CEO Alan Levine, for instance, told local press that forcing shots on the 22-hospital system’s remaining 38% of unvaccinated workers would likely exacerbate an ongoing nursing shortage. Others like Mass General Brigham and Southcoast Health told employees that the COVID-19 vaccines would be required, but only after they had received a full clearance from the Food and Drug Administration.

Here’s a roundup of the provider organizations that have announced or were reported to have adopted a mandatory vaccination policy for all employees (as of July 29) and when those policies will go into effect.


Ascension Health has told its 160,000 associates that it will require full vaccination by Nov. 12.

Atrium Health will require more than 70,000 employees across 40 hospitals to be vaccinated by Oct. 31.

Banner Health’s roughly 52,000 employees must be vaccinated by Nov. 1.

Bay State Health has told its approximately 12,000 employees, including clinical staff, contractors, volunteers, students, those working remotely or other on-site business partners, to be fully vaccinated by Oct. 1

Baylor Scott & White told press that its more than 49,000 employees and 7,300 providers, along with volunteers, vendors, students and contract staff, will need to be fully vaccinated by Oct. 1

Beacon Health System is requiring its more than 7,000 associates, 1,100 provider staff and all others “regularly working” at its facilities to be fully vaccinated by Oct. 1.

BJC HealthCare said that its workforce of more than 30,000 employees and others working in its facilities must be fully vaccinated by Sept. 15.

Children's Hospital of Philadelphia has told its staff that vaccination will be mandatory for those who are onsite or interacting with patients and families. The letter to staff did not specify when the requirement would go into effect. 

ChristianaCare said it will require all of its roughly 13,400 employees, Medical-Dental staff, residents, students, contracted employees, temporary labor, volunteers and vendors to be fully vaccinated by Sept. 21.

Community Health Network expects its 16,000 employees to be fully vaccinated by Sept. 15.

Cone Health has told 13,000 plus employees and other medical staff, students and volunteers to be fully vaccinated by July 30.

Connecticut Children’s Medical Center reportedly told employees they’ll have until Sept. 30 to be vaccinated.

Duke Health will require its roughly 22,000 employees to be vaccinated by Sept. 21.

Hackensack Meridian Health told its 35,000 employees to receive their first vaccine by Oct. 1 and be fully vaccinated by Nov. 15.

Hartford HealthCare has told its roughly 33,000 employees to show proof of vaccination by Sept. 30.

Henry Ford Health System said it will require its 33,000 workforce of team members, students, volunteers and contractors to be vaccinated by Sept. 10.

HonorHealth said that its 12,800 employees will need to submit proof of COVID-19 vaccination by Nov. 1. 

Houston Methodist was the first to mandate that its employees be fully vaccinated by a June 7 deadline. This led to 24,947 vaccinated employees, 285 with a medical or religious exemption, 332 granted deferrals for pregnancy or other reasons and 153 terminations or voluntary resignations.

Indiana University Health told its 36,000 employees to be fully vaccinated by Sept. 1.

Inova Health System is requiring its roughly 18,000 employees to be fully vaccinated by Sept. 1.

Mary Washington Healthcare announced that all employees, medical staff and volunteers must be vaccinated by Oct. 31.

Mayo Clinic said it is expecting all 65,000 of its employees to be fully vaccinated by Sept. 17

Medical University of South Carolina told its roughly 17,000 employees to be vaccinated by April 30. It fired five who did not comply.

Mercy, based in St. Louis, announced that it will require its more than 40,000 employees to be vaccinated by Sept. 30.

NewYork-Presbyterian told its 20,000 employees they must receive at least one dose of a COVID-19 vaccine by Sept. 1

New York City is requiring the roughly 42,000-person workforce of its public hospital system, Health and Hospitals, to be vaccinated by the beginning of August.

Novant Health said that it will require all team members, about 35,500 people, to be fully vaccinated by Sept. 15.

OSF HealthCare will enforce vaccination across its nearly 24,000-person workforce by Sept. 30.

Penn Medicine’s 44,000 employees must be fully vaccinated by Sept. 1. The system also requires all new hires to provide evidence of vaccination or be vaccinated as of July 1.

Piedmont Healthcare said that all doctors, hospital leaders and new employees must be vaccinated by Sept. 1 and noted that a similar policy would be rolled out “in the near future.”

Pullman Regional Hospital said that all employees will need to be vaccinated by Oct. 27.

Rush University Medical Center will require all staff, contractors and volunteers to be fully vaccinated by Oct. 1.

RWJBarnabas Health told all employees in supervisory positions and above to complete their vaccinations by June 30 and recently laid off six who did not comply. The system said during its initial announcement that it anticipates a similar requirement will be extended to the rest of its 25,000-person staff “in the coming days.”

Sanford Health has made COVID-19 vaccination mandatory across its nearly 48,000 employees, effective Nov. 1. 

SSM Health is requiring its nearly 40,000 employers, providers and volunteers to be vaccinated by the end of September.

St. Jude Children’s Research Hospital has told more than 3,600 employees to be vaccinated by Sept. 9.

St. Luke’s Health System in Idaho is requiring employees, providers, contractors, students and volunteers to have at least one dose of a COVID-19 vaccine by Sept. 1 but did not provide a date for full vaccination.

St. Luke’s Hospital, based in Missouri, is requiring team members, volunteers, physicians, independent practitioners in its facilities and vendors with patient contact to be vaccinated by Aug. 13.

Tidelands Health is mandating all employers, employed providers, volunteers, students and contractors be vaccinated by Sept. 7.

Trinity Health has rolled out a vaccine mandate for its workforce of 117,000 employees including clinical staff, remote employees, contractors and “those conducting business in its healthcare facilities.” Most locations falling under the nonprofit giant will require proof of vaccination by Sept. 21.

Truman Medical Centers/University Health is requiring its 4,500 to be vaccinated by Sept. 20. 

UCHealth said it will mandate vaccination across its 26,000 employees as well as providers, volunteers and other partners by Oct. 1.

UNC Health mandated that everyone working at six hospitals as well as its physicians’ practices and shared services locations to be vaccinated by Sept. 21.

University of Chicago Medical Center is requiring its roughly 10,000-member workforce be fully vaccinated and said that it would be implementing a similar policy for UChicago Medicine Ingalls Memorial. The provider was still determining a timeline for its mandate at the time of the announcement.

University Hospital in New Jersey said that it is requiring all staff to be vaccinated.

University of Louisville Health will require all team members and providers to be fully vaccinated as of Sept. 1.

University of Maryland Medical System will require COVID-19 vaccination for its 29,000 employees and new hires beginning Sept. 1.

Uvalde (Texas) Memorial Hospital is requiring its 493 employees to receive an initial or final dose of a COVID-19 shot by Aug. 6.

Valley Health has told affiliated providers, contractors and 6,300 employees to be fully vaccinated by Nov. 1.

The Veterans Health Administration is requiring all Title 38 Department of Veterans Affairs employees to be vaccinated, Secretary Denis McDonough announced on July 26. Each employee will have eight weeks to be fully vaccinated, he said, which from the time of announcement creates a Sept. 20 cutoff. 

Virtua Health has ordered everyone on its more than 14,000-person workforce to be fully vaccinated by Sept. 15.

Wake Forest Baptist Health will require COVID-19 vaccines among its employees. The academic health system has not publicly stated when the mandate will take place.

Yale New Haven Health leadership said in an early July press conference that it would be implementing a mandatory employee COVID-19 vaccination policy but was still working out details around timing. 

https://www.fiercehealthcare.com/hospitals/40-health-systems-requiring-mandatory-covid-19-vaccines-for-their-workforces

Pfizer court fight could legalize Medicare copays and unleash 'gold rush' in sales

 Three years ago, pharma giant Pfizer paid $24 million to settle federal allegations that it was paying kickbacks and inflating sales by reimbursing Medicare patients for out-of-pocket medication costs.

By making prohibitively expensive medicine essentially free for patients, the company induced them to use Pfizer drugs even as the price of one of those medicines, covered by Medicare and Medicaid, soared 44% to $225,000 a year, the Justice Department alleged.

Now, Pfizer is suing Uncle Sam to legalize essentially the same practice it was accused of three years ago — a fighting response to a federal crackdown that has resulted in a dozen drug companies being accused of similar practices.

A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices, say health policy analysts. A federal judge’s ruling is expected any day.

“If this is legal for Pfizer, Pfizer will not be the only pharmaceutical company to use this, and there will effectively be a gold rush,” government lawyer Jacob Lillywhite said in oral arguments last month.

Pfizer’s legal argument “is aggressive,” said Chris Robertson, a professor of health law at Boston University. “But I think they’ve got such a political tailwind behind them” because of pocketbook pain over prescription medicine—even though it’s caused by pharma manufacturers. Pfizer’s message, “‘We’re just trying to help people afford their drugs,’ is pretty attractive,” he said.

That’s not all that’s working in Pfizer’s favor. Courts and regulations have been moving pharma’s way since the Food and Drug Administration allowed limited TV drug ads in the 1980s. Other companies of all kinds also have gained free speech rights allowing aggressive marketing and political influence that would have been unthinkable decades ago, legal scholars say.

Among other court arguments, Pfizer initially claimed that current regulation violates its speech protections under the First Amendment, essentially saying it should be allowed to communicate freely with third-party charities to direct patient assistance.

“It’s infuriating to realize that, as outlandish as they seem, these types of claims are finding a good deal of traction before many courts,” said Michelle Mello, a professor of law and medicine at Stanford University. “Drug companies are surely aware that the judicial trend has been toward more expansive recognition of commercial speech rights.”

Pfizer’s lawsuit, in the Southern District of New York, seeks a judge’s permission to directly reimburse patient expenses for two of its heart-failure drugs each costing $225,000 a year. An outside administrator would use Pfizer contributions to cover Medicare copays, deductibles and coinsurance for those drugs, which otherwise would cost patients about $13,000 a year.

Letting pharma companies put money directly into patients’ pockets to pay for their own expensive medicines “does induce people to get a specific product” instead of shopping for a cheaper or more effective alternative, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University. “It’s kind of the definition of a kickback.”

Government rule-makers have warned against such payments (PDF) since the launch of Medicare’s Part D drug benefit in 2006. Drug companies routinely help privately insured patients with cost sharing through coupons and other means, but private carriers can negotiate the overall price.

Because Congress gave Medicare no control over prescription drug prices, having patients share at least part of the cost is the only economic force guarding against unlimited price hikes and industry profits at taxpayer expense.

At the same time, however, regulators have allowed the industry to help patients with copays by routing money through outside charities — but only as long as the charities are “bona fide, independent” organizations (PDF) that don’t match drugmaker money with specific drugs.

Several charities have blatantly violated that rule in recent years by colluding with pharma companies to subsidize particular drugs, the Justice Department has alleged. A dozen companies have paid more than $1 billion to settle allegations of kickback violations.

Pfizer set up an internal fund at one of the charities, the Patient Access Network Foundation, to cover patient costs for a heart arrhythmia drug at exactly the same time it was raising the wholesale cost from $220 to $317 for a package of 40 capsules, the Justice Department said. Pfizer referred Medicare patients who needed the drug to the PAN Foundation, the government said.

Under such arrangements, every $1 million channeled through a charity “has the potential to generate up to $21 m[illion] for the sponsor company, funded by the U.S. government,” Andrew Baum, a Citi pharma stock analyst, wrote in 2017.

Pfizer settled the case, saying it was not an admission of wrongdoing but resulted from its “desire to put this legal matter behind us.”

The PAN Foundation and three other charities also made deals to resolve allegations that they functioned as disallowed conduits for patient assistance for multiple pharma companies. One organization, the Virginia-based Caring Voice Coalition, shut down after government scrutiny.

PAN’s settlement did not mention the alleged Pfizer transactions. Those were described in the separate government deal with Pfizer.

The 2019 PAN agreement related to “legacy matters” and “did not involve any of PAN’s current operations or disease funds,” organization CEO Dan Klein said via a spokesperson. “Nonprofit patient assistance programs like PAN are necessary to help people access the critical medications they need to stay healthy.”

But legal troubles have hardly slowed the pharma-funded patient assistance business.

Four penalized nonprofits agreed to stop directing money to specific drugs, but they continue to accept hundreds of millions of dollars in pharma donations to indirectly cover copays and other patient drug costs, organization reports and IRS filings show. HHS regulators allow the practice because the drug companies are not involved in deciding which patients and which drugs are subsidized.

Donations to six pharma-funded patient assistance charities reached $1.8 billion in 2019, only slightly less than the year before, a KHN analysis of their IRS filings shows. That was nearly 50% higher than the amount from five years previously, before the Justice Department started cracking down.

Last year Pfizer donated $39.7 million to PAN and five other charities helping patients with out-of-pocket drug costs, company disclosures show.

If Pfizer’s lawsuit seeking to earmark such donations for its tafamidis heart-failure drugs opens the way for similar practices industrywide, it would drive up Medicare costs through rising prices and numbers of prescriptions, said Gerard Anderson, an economist and health policy professor at Johns Hopkins University’s Bloomberg School of Public Health. Such a program for tafamidis alone would increase Medicare costs by $30 billion, the Health and Human Services Department’s inspector general estimated.

Pharma companies can “learn which patients are using the drug, and they can market [and offer financial assistance] directly to that patient,” Anderson said. “You get a huge return.”

Pfizer argues that its proposal, which the HHS inspector general called “highly suspect” in an advisory opinion before the company filed its lawsuit, is legal and sensible.

“Providing copay assistance to middle-income patients who have been prescribed tafamidis is an efficient and equitable way to lower their out-of-pocket costs,” company spokesperson Steven Danehy said.

But the real affordability problem for patients is that tafamidis is too expensive, federal attorney Lillywhite said in court arguments last month. (HHS’ Office of Inspector General declined to comment.)

Pfizer has “priced itself out of the market,” he said. The company is seeking to “do something that’s unprecedented, to upend decades of settled law and agency guidance” to boost sales of “what is the most expensive cardiovascular drug ever launched in the United States.”

After the oral arguments, Pfizer dropped claims that HHS rules violate its free speech rights. Judge Mary Kay Vyskocil is considering only the company’s contention that a dedicated fund for tafamidis would not violate kickback prohibitions because, among other arguments, it is the doctor who decides to prescribe the drug and create revenue for Pfizer, not the patient getting the financial assistance.

But legal analysts still see the case as part of a broad movement toward deregulation and corporate rights.

A 1970s Supreme Court case, viewed as paving the way for an explosion of drug, lawyer and liquor ads as well as corporate campaign donations, was about speech rights for prescription drug sellers in Virginia. In 2011 the court found that the First Amendment allows data miners to buy and sell prescription records from pharmacies, provided the patients aren’t identified.

A year later, a federal appeals court cited speech protections when it overturned the conviction of a pharma sales rep who had been promoting a drug for uses not approved by the FDA.

Even if Pfizer loses its case, the climate may be ripe for similar challenges by other drugmakers, especially after the appointment of more than 200 federal judges by business-friendly President Donald Trump, legal scholars said.

The federal kickback law doesn’t mention copay assistance charities “and wasn’t designed with these programs in mind,” said Mello, of Stanford. Pfizer’s lawsuit “should be a loud, clanging call to Congress” to explicitly define drug assistance subsidies as illegal kickbacks, she said.

https://www.fiercehealthcare.com/payer/pfizer-court-fight-could-legalize-medicare-copays-and-unleash-gold-rush-sales