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FDA faults quality control at Lilly plant making Trump-touted COVID drug

By Dan Levine and Marisa Taylor

(Reuters) – U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as “a cure” for the disease, according to government documents and three sources familiar with the matter.

The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19.

Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, raising expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug. The president’s push is key to his efforts to convince voters he has an answer to the pandemic that has killed more than 215,000 Americans.

But the findings by the U.S. Food and Drug Administration inspectors at the Lilly manufacturing facility, which have not been disclosed previously, could complicate the drugmaker’s bid for a so-called emergency use authorization (EUA) from the federal agency, two of the sources and two outside legal experts told Reuters. That’s because U.S. law generally requires compliance with manufacturing standards for authorization of a drug.

The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation.

Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show.

“The deleted incidents and related audit trail were not reviewed by the quality unit,” the FDA inspectors wrote. Because the government inspection documents reviewed by Reuters were heavily redacted by the FDA it was not possible to see the inspectors’ more specific findings.

Following its November inspection, the FDA classified the problems as the most serious level of violation, resulting in an “Official Action Indicated” (OAI) notice.

That “means that the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,” said Patricia Zettler, a former associate chief counsel at the FDA who is now a law professor at Ohio State University.

Separately, Lilly said on Tuesday it had paused its clinical trial for the COVID drug in hospitalized patients “out of an abundance of caution” over a potential safety concern. The company did not release information on what the problem was and declined to say how the news might affect their EUA request.

In response to Reuters’ questions on Monday about the manufacturing issues, Lilly confirmed the OAI notice but declined to provide details on what prompted the FDA action. The drugmaker said it has launched a “comprehensive remediation plan,” has increased staffing at the site and was working “aggressively” to address all concerns raised during

Companies are making some changes for employees health insurance amid the pandemic

More coverage for virtual doctors’ visits. Expanded mental health benefits. Access to on-site health clinics.



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As employees sign up for job-based coverage for 2021, they’ll find the coronavirus pandemic has changed some of the benefits that their companies are providing, experts said.

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And they’ll also see their premiums and out-of-pocket costs increase about 5%, which is more than wages and inflation have been rising, according to the Business Group on Health, which surveys large employers.

This bump comes on top of a 4% increase in premiums this year, according to the Kaiser Family Foundation’s annual employer health benefits survey. In 2020, the average annual premiums hit nearly $7,500 for single coverage and $21,500 for family coverage. Deductibles stayed roughly the same at about $1,650 for a single person.

One of the biggest changes for 2021 will be a growth in the number and types of virtual care options, said Steve Wojcik, the group’s vice president of public policy. Employers had long offered telehealth, but few of their staffers actually used it.

The pandemic changed all that. Utilization soared as Americans sought medical care from the safety of their homes.

Some 53% of large employers will offer more virtual care options next year, the group found. And they are extending the services to weight management, prenatal care and management of chronic diseases, including diabetes and cardiovascular disease.

Coronavirus, as well as the accompanying economic upheaval, has also greatly affected many Americans’ mental health. Companies plan to bolster their support and make employees more aware of the offerings available to them, said Mark Hope, senior director at Willis Towers Watson.

Some 45% of large employers are planning to work with their insurers to expand mental health provider networks, according to the Business Group on Health report.

Some 91% of large employers said they would offer virtual mental health services in 2021, up from 73% in 2019. And 65% said they would provide virtual emotional well-being services next year, up from 45% in 2019.

And nearly nine in 10 employers will offer access to online mental health resources, including apps, videos and webinars.

Meanwhile, 61% of employers plan to have an on-site clinics, which can provide coronavirus testing, in addition to basic health services. This ticked up from 58% this year.

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Equinox’s Variis App Is Making the Best of Boutique Fitness Accessible to All

When Equinox launched Variis—its first foray into digital fitness—earlier this year, it came with one major caveat: In order to access it, you had to either be an Equinox member or shell out $2500 for the SoulCycle at-home bike. As of today, though, the app is officially available to everyone, proving that an accessible blend of in-person and online workouts are officially the wave of the future.

In addition to Variis’s OG streaming workouts (spin classes from SoulCycle, treadmill sessions from Precision Run, yoga flows from PureYoga, and meditation and recovery classes hosted by Equinox trainers), the latest iteration of the platform will also stream classes from Solidcore, Rumble, and TB12, plus real-time, live classes. Or you can tune out and watch Netflix, Amazon, and Disney+.



a woman holding a phone: Variis


© Photo: Getty Images/Oscar Wong
Variis

At $40 a month, Variis pricing is in line with others in the industry (the “all-access” pass required to access Peloton’s spinning and treadmill classes costs $39 a month, while Obé charges $35 a month for its streaming service). If you consider that a single, in-person Solidcore class in New York City costs $32 and a SoulCycle class will run you $36, paying $40 for unlimited access to the digital classes could save you big in the long run. This, it seems, is representative of a larger, industry-wide shift of boutique gyms using affordable digital fitness to make their selections more widely available.

Over the last few months, after stay-at-home orders made living room workouts our only option, Equinox—like many other pricey, cult-fave brands such as Barry’s, AARMY, and SLT—have embraced an omnichannel approach of blending in-person and online classes, and this model is decidedly here to stay.  “I think people were kind of in one camp or the other before…but now it’s not an either/or—it’s what I call a hybrid model,” David Miller, the executive director of the Center for Innovation and Entrepreneurship at George Mason University’s School of Business previously told Well+Good. “When you look at what’s emerging, people are now more open [to doing both at-home and in-studio workouts], and are going to mix and match.”

As far as luxury gyms go, Equinox has long been the industry’s gold standard, but its clubs have only been located in major metros. This means that by removing the membership requirement for Variis and shipping the Soul bike nationwide, Equinox has done away with its financial and geographic barriers to entry, placing the brand squarely in competition with other major players in the space—including Peloton.

In the last seven months, Peloton’s stock ticked up more than 345 percent, and its app reportedly saw five times more downloads in March (when gyms in the US were forced to close) than it did in February. It remains to be seen whether or not Variis will see the same sort of success, but considering a 2,009-person survey from TD Ameritrade found that 59 percent of Americans say they don’t plan on renewing their gym memberships even after the pandemic is over,

‘I Lost Over 100 Lbs. In 1.5 Years By Making These 4 Simple Tweaks To My Diet’

My name is Ashley Kincade (@ashleyloveebugg), and I am 25 years old. I live in Chandler, Arizona, and I am an operations manager. I was tired of having knee pain and no energy, so I worked with my doctor to create a calorie deficit to lose weight and did at-home YouTube workouts and High Fitness classes to lose over 100 pounds.



a woman standing in front of a mirror posing for the camera: Ashley K. lost over 100 lbs. after her doc helped her calculate a daily calorie intake and cut processed foods. She also did High Fitness and Youtube workouts.


© Ashley Kincade
Ashley K. lost over 100 lbs. after her doc helped her calculate a daily calorie intake and cut processed foods. She also did High Fitness and Youtube workouts.

Before my weight loss journey, I struggled with overeating, food addiction, emotional eating, and yo-yo dieting. I was always too fatigued to workout, and I would end up giving up on working out because I thought it was too hard.

My feet and legs hurt all the time, and I was in my early 20s. I also had a knee injury, and moving around on it at my bodyweight prevented it from fully healing. I knew if I lost weight it would take the pressure off of my legs and my knees. I felt uncomfortable and out of breath even doing simple activities like running errands, like my body was entirely drained of energy.

I went to the doctor and she explained to me that I may develop other health issues. I didn’t want to be unhealthy at only 23.

So, I decided to make a New Year’s resolution in January 2018, and it was the only New Year’s resolution that I actually accomplished.

What made this resolution different from the others is that I shared with everyone that I knew that I was starting a weight loss journey. Telling all of my friends and family is what helped keep me accountable. I just wanted to be able to look in the mirror and feel good about myself again.

I’m allergic to dairy and soy, so I struggled when I first started my weight loss journey because I wasn’t sure what to eat. I would always go for unhealthy foods because it was the quickest and easiest thing that I could just grab and not have to think about.

When I began my health journey, I talked to my doctor about what types of food I should try incorporating into my diet, and she told me to always stay in a calorie deficit. I now try to stay away from as many processed foods as possible, and I also try not to eat a lot of carbs. (I don’t necessarily follow a low-carb diet or anything, but I try to stay away from unnecessary carbs.) It took a lot of trial and error to find what would keep me full and what I could make quickly, since I work retail.

I started by changing what I ate for breakfast every day. Once I got the hang of that, I changed what I ate for lunch, followed by snacks and dinners.

I now been eat a well-rounded

Fitness and nutrition studio is making most of telehealth boom, expanding operations

Since the coronavirus began threatening people’s health and wellness, Jim White has seen a boom in telehealth and fielded more clients than ever before.

In this down and up year, the founder of Jim White Fitness & Nutrition Studios is celebrating its 20th anniversary and opening a new location on First Colonial Road in Virginia Beach.

The expansion — planned pre-COVID — will take care of the growing pains the business had over the last 10 to 15 years and enable White and his team to help more people.

“This gives us the opportunity to streamline our processes and recreate our brands,” White said.

Two of the Virginia Beach studios – Hilltop and Great Neck – will relocate to the new space which White said is geographically in the middle of both. The one in downtown Norfolk will remain and White said he’s looking at other areas of Hampton Roads to invest in.

“When we first started we only had one dietitian and now we’re employing up to eight,” he said. “We realized when they come back – maybe November or December – we needed to have a bigger space.”

In April, White bought the almost 8,000 square foot building for $1.175 million. Approximately half the space will be rented to an eye doctor’s office. That still will leave him with more space than the other two Beach studios had combined.

Located on “medical row,” the new location will enable the business to more easily connect with physicians to help clients through nutrition and fitness.

“It’s going to open up a lot of creativity,” White said of the space that will be outfitted with new equipment.

An accomplished fitness expert and leader in the field, White’s resume touts a lengthy list of credentials, awards and honors, interviews (print, television, web, and radio), and public speaking engagements.

And even during the pandemic, White has remained dedicated to helping clients through the difficult days.

After closing the doors to his facilities for 70 days at the start of the pandemic, he said they were forced to diversify very quickly.

“Our registered dietitians were approved with telehealth so they’ve been working at home since March,” White said. “It’s been really big because a lot of people feel safe in their homes.”

One-on-one and small group virtual trainings were enabled so people could be at home while the trainers were at home or in the studio.

Outdoor training was also incorporated in March, April and May.

In June, when the governor lifted some of the mandates, White said they picked up a record number of clients over the next two months.

The boutique fitness studio attracted more attention than they did before the virus because many people were apprehensive about going to the big box gyms.

“Our nutrition side hasn’t slowed down since we started telehealth, in fact, we’ve had less cancellations,” White said.

White employs 27 people, including certified fitness and nutrition experts that provide tailored personal training programs for individuals

Pandemic AVR: Making Patients Wait May Do More Harm Than Good

Recent cardiac events suffered by patients with symptomatic severe aortic stenosis (AS) could be tied to whether their hospitals expedited aortic valve replacement (AVR) in select cases or paused these procedures in response to COVID-19, two reports suggested.

In the first, a Swiss hospital showed success selecting patients for expedited AVR despite safety concerns during the pandemic, whereas a New York City center that pushed these procedures back for everyone had a substantial number of patients subsequently die or require urgent transcatheter AVR (TAVR) while waiting, the second found.

Both reports were published online in JAMA Network Open.

“Taken together, these studies provide useful guidance. First, as we have known for many years, symptomatic AS is a life-threatening condition, and its treatment cannot be considered elective in any way. Patients with the most echocardiographically severe stenosis, clinically advanced symptoms, or comorbid coronary artery disease or lung disease belong at the head of the line,” according to Thoralf Sundt, MD, of Massachusetts General Hospital and Harvard Medical School in Boston.

“Whether one chooses to interpret the current state of the pandemic as an ongoing first wave — perhaps with a nadir in some regions — or as the quiet before a second wave, there is a clear need for tools permitting precise triage of patients by the urgency with which procedures should be performed,” he emphasized in an accompanying editorial.

Selective AVR in Switzerland

Certain people with critical AS were good candidates for expedited AVR during a nationwide ban on elective procedures, according to the prospective AS DEFER study.

A cohort of 71 patients referred for AVR from March 20 to April 26, a period when Switzerland banned elective procedures in all hospitals, were divided into two treatment groups according to a prespecified algorithm:

  • Expedited (n=25): Patients with critical AS (i.e., aortic valve area ≤0.6 cm2, transvalvular mean gradient ≥60 mm Hg, cardiac decompensation during the previous 3 months, or exercise intolerance with clinical symptoms on minimal exertion) who underwent TAVR at a mean 10 days after referral
  • Deferred (n=46): Patients with a larger aortic valve area and stable symptoms

Adverse cardiac outcomes were not statistically more likely for either group at an average 31 days after treatment allocation: the composite endpoint of all-cause mortality, disabling and nondisabling stroke, and unplanned hospitalization for valve-related symptoms or worsening heart failure reached 4.0% of the expedited group versus 19.6% of those deferred (log rank P=0.08), reported Thomas Pilgrim, MD, MSc, of Inselspital, Bern University Hospital, and colleagues.

Hospitalizations were more likely in the deferred AVR arm than the expedited arm (19.6% vs 0.%, P=0.02) and accounted for all the primary outcome events in the former. No patient died.

Among deferred AVR patients, those who wound up requiring hospitalization for valve-related symptoms or worsening heart failure had more commonly presented with multivalvular disease (44.4% vs 8.6%, P=0.02), suggesting that this group in particular may benefit from expedited AVR, Pilgrim’s group said.

“I cannot tell if the authors considered

These Orgs Are Making Sure the Future Has Black Doctors

Only 5 percent of doctors in the U.S. identify as Black.

This is Race and Medicine, a series dedicated to unearthing the uncomfortable and sometimes life-threatening truth about racism in healthcare. By highlighting the experiences of Black people and honoring their health journeys, we look to a future where medical racism is a thing of the past.


Thanks to the Black Lives Matter movement, racism and anti-Blackness are being examined in many American industries: healthcare is one of them.

In addition, the way in which COVID-19 has specifically impacted Black Americans now makes the inherent racism within healthcare very clear.

The current pandemic is exposing the consequences of racial discrimination within healthcare industries at every level. However, anti-Blackness in medicine and other related health disparities is nothing new for Black people.

The medical field has historically been an industry that perpetuates neglect and prejudice towards Black patients. There is also a notable lack of Black representation in active doctors and physicians in the United States.

According to the Association of American Medical Colleges (AAMC), in 2018 only 5 percent of all active physicians in the United States identify as Black or African American compared to 56.2 percent of active physicians in America who are white.

The lack of Black doctors and medical staff who have the ability to recognize health concerns in Black patients may have life threatening consequences.

Misogynoir, a term coined by Moya Bailey that means hatred of Black women, continues to perpetuate medical harm.

For example, according to the Centers for Disease Control and Prevention (CDC), an average of 700 women die each year in the United States from pregnancy-related complications. However, Black women are two to six times more likely to die due to pregnancy complications than white women.

To combat the effects of racism and lack of Black representation in the medical field, there are a number of organizations advocating for Black, Indigenous, and People of Color (BIPOC) students and doctors with the goal of breaking barriers and diversifying the healthcare industry.

Here are some of the organizations doing the work to make sure the future has more Black doctors and healthcare professionals.

The Society of Black Academic Surgeons (SBAS) has been advocating to “improve health, advance science, and foster careers of African American and other underrepresented minority surgeons” for over three decades.

In addition to diversifying faculty in academic surgery, SBAS seeks to promote their members into leadership positions as well as eliminate health disparities against BIPOC patients.

SBAS values mentoring its members in fellowship programs to achieve the goals stated in the organization’s mission statement.

Membership benefits for students within SBAS include access to the organization’s resources for the opportunity to enter their chosen medical profession and prepare for residencies.

They also offer access to a network of like-minded colleagues within the organization, opportunities to save money through SBAS student members-only programs, and more.

The Association of Black Women Physicians (ABWP) is a nonprofit organization networked by Black women to support BIPOC