Older adults who consumed large amounts of flavonoid-rich foods were two to four times less likely to develop Alzheimer's disease and related dementias over 20 years compared with people whose intake was low, in a study of 2,800 people.

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.

Leaders from around the world gathered at the United Nations General Assembly in New York on 23 September for the first-ever United Nations High-Level Meeting (UNHLM) on Universal Health Coverage (UHC): Moving Together to Build a Healthier World.

A duo of innovative programmers from Malaysia are the winners of the 2019 APEC Digital Prosperity Award, announced on the sidelines of the APEC Informal Senior Officials’ Meeting in Langkawi.

Business leaders from the Asia-Pacific region called for APEC leadership and cooperation to combat the grave challenges to health and economies posed by the COVID-19 pandemic.

Medical supplies and personal protective products are facing barriers worldwide

From : Communities>>Regulatory Open Forum
Hello,  I can see many unapproved combinations of Minoxidil as topical solution like minoxidil+ Azelaic Acid; Minoxidil + Finasteride; Minoxdil+ niacin+retinol+caffeine that are available online for sale in US but these drug products are not approved by FDA as visble from USFDA website.  Can anyone explain that is there any mechanism or guideline to allows to sell such unapproved drug products online in US and also in EU? Or is this totally illegal practice?  Thanks Ankur RAC

From : Communities>>Regulatory Open Forum
Hi, Ankur - Some may be "legal," others not. It's a big industry, and it is fair to be cynical. Combination products for sale that have not been approved-as the combination-by FDA are just that, unapproved drugs. I assume you checked for the approval status in FDA's "Orange Book" (https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm). Even if both active pharmaceutical ingredients in a 2-drug mixture were approved separately on their own, it does not mean the combined product is approved for [More]

From : Communities>>Regulatory Open Forum
These are all unapproved new drugs. Many people who have very limited knowledge of our OTC drug system, assume that if it is sold OTC, it is a monographed drug and they can change the formulation. They do not know that there are two types of OTC drugs allowed-compliance with a monograph or NDA. Minoxidil is one and chlorhexidine antiseptic wash is another. ------------------------------ David Steinberg,FRAPS President Steinberg & Associates, Inc. Pompton Plains NJ USA 609-902-8860 -------------- [More]

From : Communities>>Regulatory Open Forum
The only  possible way I can see any of these products being legally marketed in the US without going the OTC NDA route would be if the ingredients  other than Minoxidil are considered "inactive" and have some purpose (other than their active ingredient purposes) in the formulation.  That said, this might work for the last combination in your listing because all of these can and are often used in OTC products as inactive ingredients with understood and current reasons for existing in a formulation [More]

From : Communities>>Regulatory Open Forum
These types of products and combinations you mention are all unapproved drugs and unapproved combinations.  Unless the specific combination is approved or listed in an OTC monograph, it is a new drug and requires a NDA to market it.  Minoxidil is a Rx to OTC switch product so it requires a NDA or ANDA to market this drug in the US, even as a OTC drug.  Thus any combination with minoxidil is a new drug. In the past the FDA has also specifically stated that combining different types of products (drug [More]

    WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

December 1, 2018

Mr. Kris Kringle, Owner
Santa’s Workshop, LLC
1225 Santa Clause Way
North Pole, Arctic Circle
 
Dear Mr. Kringle:

The U.S. FDA inspected your manufacturing facility, Santa’s Workshop, LLC at
1225 Santa Claus Way, North Pole Arctic Circle, from April 2 to April 20, 2018.

This warning letter summarizes significant violations of CGMP regulations for finished product. See 21 CFR, parts 210 and 211. During our inspection, our investigators observed specific violations including, but not limited to, the following.

CGMP Violations

1.    Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a) and 211.28).

Many members of your Enterprise Labor Force (ELF) unit lacked sufficient prior experience for designing and assembling (b)(4). At the time of our inspection, no ELF members had received training on CGMPs, and most were unaware of their responsibilities in the areas of cleanliness and proper attire. Hands and faces were often coated with chocolate, and bells on hats and shoes prevented protective apparel from attaining a proper fit. More generally, factory staff demonstrated an undisciplined, almost gleeful disregard for quality procedures. On three separate occasions, at critical stages of the manufacturing process, floor workers erupted into spontaneous song and dance.



Your written response of May 18, 2018 is inadequate because it does not address these training and experience deficiencies. While endearing, the ability to “sit on a shelf” or “live in a hollow tree” does not constitute acceptable manufacturing experience. Candy coating does not qualify as protective covering. And sticking one’s hands in a nearby snowdrift is not a recognized sanitation procedure. “Pure as the driven snow” is not a thing. Especially with all those reindeer knocking about.

2.    Your firm failed to maintain a system by which the distribution of each lot of product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).

Product distribution records were incomplete and, in the event of a recall, would be insufficient to identify all product recipients.

Your written response of May 18, 2018 is inadequate. Santa’s Own Procedures (SOPs) are insufficient to capture the information required to conduct a thorough recall.  Mr. Kringle may well know which customers are naughty and which are nice -- who’s good, who’s bad, who’s sleeping, and who’s awake, but this information is not written down and, in the opinion of our investigators, would be of limited value if it were.

3.    Your firm failed to store product at an appropriate temperature to ensure the identity, strength, quality, and purity of the products are not affected (21 CFR 211.142(b)).

Entire sections of the facility lacked effective air conditioning, resulting in destruction of all (b)(4) warehoused in two large storage rooms. A third inadequately cooled room was not in use, and except for some miscellaneous items – a couple hunks of coal, a corncob pipe, and a large, oddly sad puddle of water – the room was all but empty.

Your written response of May 18, 2108 was inadequate. FDA isn’t really sure what to do with “that old silk hat we found” in your response package.

4.    Products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed (21 CFR 211.165(f)).

While not strictly a violation of 21 CFR 211.165(f), the rejection and quarantining procedures your firm follows for products that fail to meet established criteria is concerning. While it’s appropriate to reject a (b)(4) that swims, a (b)(4) with square wheels, a (b)(4) that shoots jelly, and a (b)(4) that rides an ostrich, exile to a remote island ruled by a flying lion is, in a word, extreme. Your firm also rejected and exiled a (b)(4)-in-a-box for what was almost certainly an easily remediated labeling problem; reprocessing would have been a more appropriate course of action. Also, we just have to know. Seriously. WHAT WAS WRONG WITH THE DOLLY???

5.    Your firm failed to establish adequate acceptance criteria for sampling and testing necessary to assure that batches of product meet appropriate specifications as a condition of their approval and release (21 CFR 211.165(d)).

Sampling procedures consisted of pulling each finished batch of (b)(4) out of a hot oven, taking a few nibbles, and declaring it “Jingle-icious.” Testers would frequently adulterate samples by submersing and saturating them with milk. These procedures are totally without scientific rigor. Furthermore, sampling was not restricted to members of the Quality Control Unit, but was extended to the entire plant floor. At times, sampling frequency was so high that there was very little, if any, of (b)(4) left to distribute. (On a personal note, our investigators would like to express their appreciation for the opportunity to participate in the testing activity. All the batches they sampled exceeded the strictest statistical quality control criteria, excepting the fruitcake, which could have benefited from additional stability testing and an earlier expiry date.)

Conclusion

Violations in this letter are not intended as an all-inclusive list. Typically the manufacturer is responsible for investigating violations, determining their root causes, and preventing their recurrence. However, in this case we’re going to make an exception. Though your methods and procedures are unconventional and frequently out of compliance with regulations, they are not wholly without merit. Our investigators have never experienced such a high level of workplace morale -- some calling it “downright merry” – and believe it warrants further observation. Investigators have suggested a series of mutually consultative visits to your workshop. Music, dance, batch samples, reindeer games, and the occasional adulterated eggnog are highly encouraged.

Sincerely,
/S/
Holly Bush
Division Director/OPQO Division I
North Pole District Office

Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…

The results of a 33-patient study conducted by a Burlington biotech suggest its long-acting steroid injection for osteoarthritis of the knee may be safer for the large percentage of those patients who also have type 2 diabetes. Flexion Therapeutics (Nasdaq: FLXN) has for years been developing its lead drug candidate, Zilretta (formerly called FX006), a reformulation of a common corticosteroid that’s used with osteoarthritis patients. Flexion’s version combines the drug with a employs proprietary…

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)

The Alliance met (virtually) on April 15 with Dr. Caitlin Boon, FDA Associate Commissioner for Food Policy and Response and several of her colleagues. She described CFSAN’s and CVM’s role in responding to the current pandemic, as well as how the agency is assuring a continued safe food supply. About 50% of food spending in the […]

WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage.

The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee.

“Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.”

Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs.

Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind.

###

 

Sangamo plans to utilize Mogrifyâs cell conversion technology to develop CAR-Treg cell therapies.

The company receives approval for MenQuadfi to prevent meningococcal disease.

Sanofiâs insulin aspart biosimilar receives positive opinion from the EMAâs CHMP.

Alexion agrees deal for Portola to gain access to its lead product, Andexxa, a treatment that counteracts anticoagulants.

Posted by Roger Bate The Economic Times of India covered our new paper today (see here). The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times (see here), shows that Indian firms send their worst quality medicines to Africa. It is a shame that Indian Industry hack DG Shah continues to trot out the same arguments attacking us rather than addressing the paper’s findings. For example, he asks why did it take so long to publish a study [...]

by Wendi C. Thomas, MLK50: Justice Through Journalism

MEMPHIS, Tenn. — On her first day at her new warehouse job, Daria Meeks assumed the business would provide face coverings. It didn’t.

She assumed her fellow workers would be spread out to account for the new coronavirus. They weren’t.

There wasn’t even soap in the bathroom.

Instead, on March 28, her first day at PFS, which packages and ships makeup and jewelry, Meeks found herself standing alongside four other new workers at a station the size of a card table as a trainer showed them how to properly tuck tissue paper into gift boxes.

The following day, Meeks, 29, was just two hours into her shift when she heard that a worker had thrown up.

“They said her blood pressure had went up and she was just nauseated, but when we turned around, everybody who was permanent that worked for PFS had on gloves and masks,” Meeks said.

Temporary workers like her weren’t offered either.

Since then, workers have been told twice that coworkers have tested positive for the coronavirus. The first time was April 10 at a warehouse just across the state line in Southaven, Mississippi. The next was April 16 at the warehouse in southeast Memphis where Meeks worked, several temporary and permanent workers told MLK50: Justice Through Journalism and ProPublica.

In interviews, the workers complained of a crowded environment where they shared devices and weren’t provided personal protective equipment. The company has about 500 employees at its four Memphis-area locations, according to the Memphis Business Journal.

In right-to-work states such as Tennessee and Mississippi, where union membership is low, manual laborers have long said they are vulnerable, and workers’ rights advocates say the global pandemic has underscored just how few protections they have.

A spokesman for Tennessee’s Occupational Safety and Health Administration confirmed that the department received an anonymous complaint about PFS in April.

“A few of (sic) people have tested positive for Covid-19 and the company has not taken precaution to prevent employees from contracting the coronavirus,” the complainant wrote. “As of today (04/13/2020) no one have (sic) come to clean or sanitize the building.”

In response, the spokesman said TOSHA sent the company a letter “informing them of measures they may take to help prevent the spread of COVID-19.”

PFS did not answer specific questions about the number of workers infected at its facilities or about specific precautions it takes. Instead the company released a short statement that said PFS “is committed to the safety and well-being of its employees.” It also said it performs temperature checks at the door and supplies workers with masks, gloves and face shields.

But workers said none of these measures were in effect as late as the middle of April, when Shelby County, Tennessee, and DeSoto County, Mississippi, each home to two PFS facilities, were reporting more than 1,600 coronavirus infections and 30 deaths. (As of Friday, there are more than 2,750 infections and 50 deaths in the two counties.) A current employee said the company now provides gloves and masks, but they’re optional, as are the temperature checks.

When Meeks started at PFS, cases in the county were still at a trickle. But she didn’t stick around long.

On her third day at work, workers were split into two groups for lunch, but the break room was still full. “You could barely pull out a chair, that’s how crowded it was,” she said. “Everybody was shoulder to shoulder.”

Meeks said she asked the security guard at the front desk if she could eat her lunch in the empty lobby but was told no.

“I said, this is just not going to work,” said Meeks, who was paid $9 an hour. “You got different people coughing, sneezing, allergies — you never know what’s going on with a person.”

She left during her break and didn’t come back.

Economy Dominated by Low-Wage Industry, Jobs

In cities across the country, workers at Amazon facilities and other warehouses have been infected with COVID-19, as have workers at meatpacking plants nationwide.

What makes Memphis different is the outsized share of the workforce in the logistics industry, which includes warehouses and distribution centers.

The Greater Memphis Chamber of Commerce boasts on its website that the logistics industry employs 1 in 6 workers in the Memphis metro area, a higher share than anywhere else in the country.

The high concentration of these low-wage jobs is a testament to the city’s decades-old campaign to brand itself as “America’s Distribution Center.” Memphis is home to FedEx’s headquarters and its world distribution hub, which is undergoing a $1.5 billion expansion, as well as to Nike’s largest global distribution center, a sprawling 2.8 million-square-foot facility.

According to 2019 data from the U.S. Bureau of Labor Statistics, more than 58,000 workers in the Memphis metro area fill and stock orders, package materials and move materials by hand.

In Memphis, workers at distribution centers for FedEx, Nike and Kroger have tested positive for the coronavirus. The Shelby County Health Department received 64 complaints about businesses between April 1 and April 29, but could not say how many were about warehouses.

Interim guidance from the Centers for Disease Control and Prevention calls for employers to notify workers of positive cases. But it is voluntary. The federal OSHA has no such requirement, and neither does Tennessee’s OSHA.

Although Congress passed the Families First Coronavirus Response Act, which provides two weeks paid sick leave for coronavirus-affected or infected workers, it doesn’t apply to many warehouse and temporary employees, said Laura Padin, senior staff attorney at the Washington-based National Employment Law Project, which advocates for better public policy for workers, particularly low-wage workers.

“The big issue is that it exempts so many employers, especially employers with over 500 employees,” Padin said. “And the vast majority of temp workers and many warehouse workers work for employers with more than 500 employees.”

The coronavirus has disproportionately affected people of color, the very group that makes up the bulk of the warehouse and temporary workforce.

“Black workers make up 12% of the workforce but 26% of temp workers, and Latino workers make up 16% of the workforce but 25% of temp workers,” said Padin, citing Bureau of Labor Statistics data released in 2018.

Add to that the yawning racial wealth gap and low-wage workers like Meeks are in an untenable situation, Padin said.

“They either stay home and they risk their financial security,” Padin said, “or they go to work and risk their lives.”

“You Can Always Go Back”

With 1.45 million square feet of warehouse space among its four area locations, PFS is the ninth-largest third-party distribution operation in the metro area, according to the Memphis Business Journal’s 2020 Book of Lists. PFS doesn’t sell products under its own name but rather fulfills orders for better-known companies.

Pandora, which is perhaps best known for its charm bracelets, is one of PFS’s clients. “Each item shipped for PANDORA is wrapped in customized, branded, and sometimes seasonal packing materials, making every purchase a gift,” PFS’s website says.

Meeks’ favorite part of her job was taking each customer’s personal message, tucking it into a tiny envelope and then into the gift package.

“When we were sending out these Pandora bracelets and these Chanel gifts, I sat there and read all my cards,” said Meeks, who like all of the workers interviewed for this story, is black. “They were so cute.”

One Pandora customer sent a note to “beloved mother,” Meeks said, and another seemed to be from someone in a long-distance relationship.

“He was like: Even though I’m miles and miles away, I always think about you,” Meeks said. He wrote that he hoped the jewelry would “glitter in your eyes, or something like that.”

The day Meeks quit PFS, she said she called Prestigious Placement, the temporary agency that sent her there, asking for another job.

The temporary agency representative “was like, ‘Well, you can always go back to PFS until we get something else,’ and I was like, ‘No.’”

“She said, ‘Well, we haven’t had anyone to get sick,’” Meeks recalled.

Meeks said she tried to explain that regardless of whether some workers had tested positive, the company wasn’t taking enough steps, in her opinion, to keep current workers safe.

The representative said she’d ask the agency’s on-site manager about Meeks’ concerns, but Meeks said that there was no on-site manager present on her second or third day.

Prestigious Placement did not respond to multiple requests for comment for this story.

A local labor leader said Meeks’ experience illustrates the tough situation for temporary workers at warehouses.

“They tend not to have benefits, sick time and insurance and all the things that allow us to keep our whole community safe during a pandemic,” said Jeffrey Lichtenstein, executive secretary of the Memphis Labor Council, a federation of around 40 union locals.

Unlike companies such as Nike and FedEx, which have reputations to protect, the general public doesn’t know who PFS is or what it does, he said. “They have no brand vulnerability,” he said.

With little leverage to exert on businesses, these workers are up against a regional business model that mires them in dead-end, low-wage jobs, Lichtenstein said.

The city’s power brokers, he said, “have a couple of main tenets of their economic philosophy. One, logistics is really, really important, and two, cheap labor is very, very important.”

“Nothing Essential About It”

Memphis Mayor Jim Strickland issued a “Safer At Home” executive order on March 23, mirroring those put in place elsewhere. But the order specifically exempted warehouses and distribution centers from COVID-19 restrictions.

PFS gave workers a letter that cited Strickland’s order and the U.S. Department of Homeland Security’s guidance that “transportation and logistics are deemed a critical infrastructure that must be maintained during the COVID-19 crisis,” according to a copy reviewed by MLK50.

If they were stopped by authorities on the way to work, employees were told, this letter would ease their passage.

Some workers questioned whether the distribution center should be open at all.

“I don’t see nothing essential about it,” said one employee who asked to remain anonymous for fear she’d be fired for talking to a journalist. “It don’t got nothing to do with nurses or health.”

When a worker tested positive at a PFS distribution center in southeast Memphis, the employee, who worked at a Southaven, Mississippi, location about eight miles away, worried that the virus could spread if workers were shuffled between sites.

A manager assured her that workers would stay put, the employee said. But on April 16, a supervisor told workers that two Memphis workers, who had been brought in to the employee’s Southaven facility, had tested positive for the coronavirus.

“I said, ‘Well, since y’all got everybody in here messed up, can’t you call and get everyone in there a COVID-19 test?’” she remembered. “They said if you don’t feel safe, you can go home.”

She can’t risk taking the virus home to a relative, who has chronic illnesses, and she can’t afford not to work. “I’m concerned for my health,” she said. “I don’t want to die.”

Padin, who works with workers’ rights centers across the country, said she’s not aware of much being done by advocates to narrow the list of businesses considered essential. “I do think some of these essential worker orders are quite broad,” she said. “Our sense is that it’s a little arbitrary and just seems to be a result of lobbying.”

She pointed to the success of meat processing plants, which were declared “critical infrastructure” by President Donald Trump despite coronavirus outbreaks that sickened thousands and killed dozens.

Days before Trump’s declaration, meatpacking giant Tyson ran a full-page ad in The New York Times saying “The food supply chain is breaking.”

In Memphis, an amended executive order, signed by the mayor April 21, clarified which distribution centers and warehouses could remain in operation, including ones that handle medical supplies, food and hygiene products.

The order would seem to exclude facilities such as PFS. “Products and services for and in industries that are not otherwise identified in this provision constitute non-essential goods and services,” reads the order, which is set to expire at midnight Tuesday. On Monday, Memphis will move into the first phase of its “Back to Business” plan, which means nonessential businesses can operate with face masks, social distancing in the workplace, and symptom checks.

“No Social Distancing”

Because the turnover in warehouses like PFS is high, the need for a steady flow of labor is paramount. And temp agencies are a major source of employees.

One Memphis mother saw a job posting on Facebook for PFS. A family member’s workplace had closed because of the coronavirus, so the woman rushed to find work to make up for the lost household income. She was hired in late March by Paramount Staffing and sent to a warehouse in Southaven, Mississippi. She wanted to remain anonymous for fear of job retaliation.

From the moment workers entered the building, she said, they were close together. A single-file line funneled workers past several time clocks, one for PFS’s permanent workers and one for each staffing agency with temporary workers there.

“Some people have masks on, some don’t,” said the worker, who earned $9 an hour. Workers weren’t provided any personal protective equipment.

She opted to be a packer, a mostly stationary job, but she had to use a shared tape dispenser to seal boxes and her co-workers were within arm’s reach.

Her other job option was as a picker, but they’re in motion most of the shift, selecting products for individual orders from totes and using a shared scan gun. Pickers send the completed orders to packers.

“It’s basically no social distancing at that warehouse,” she said. “They’re gonna have to work on that.”

About two hours before her shift ended April 10, a manager huddled workers in her area together for an announcement.

“He said, ‘Well, we’re just letting y’all know that we have an employee here who tested positive and we are asking everyone here to leave the building immediately and we will clock y’all out,’” the worker recalled.

The manager instructed them not to touch anything as they left, “just go straight out the door and we will let y’all know when to return,” she recalled.

The warehouse was closed for the next day and reopened the following day.

“It makes me nervous because my health is important to me, but at the same time, it’s like that’s the only thing I can do right now,” she said.

She’s grateful for the job but insists she won’t be there long. “I’m going to try to get in a couple more checks and then I’m going to quit.”

She left about a week ago, but hasn’t found another job yet.

Paramount Staffing, which sent the worker to PFS, relies on the client to provide personal protective equipment to workers, said company president Matthew Schubert.

“My understanding is that they’ve been taking temperatures as employees walk in,” Schubert said, plus performing more frequent cleanings and coaching the workers on social distancing, but he acknowledged he didn’t know when any of those measures began.

“What we want to make sure is that they’re doing everything in their power to follow the CDC guidelines,” said Schubert, who estimates Paramount has 75 to 80 workers at PFS’s area warehouses.

“We’re limited as to what we can and cannot do, because it’s not our facility.”

Both Lichtenstein and Padin say it’s the worksite employer’s responsibility to provide personal protective equipment.

A Perfect Combination: Higher Pay and Less Risk

Just days after Meeks quit PFS, she turned to a different agency and was sent to a Memphis warehouse that labels and ships cleaning products.

Her first day was April 17, and she was impressed by the precautions the employer takes.

Before workers enter the building, Meeks said, their temperatures are taken in a white tent outside. If they don’t have a fever, they get a wristband that is a different color each day.

The company provides masks, gloves and goggles, she said, and there are even kickstands on the bathroom doors, so they can be opened by foot.

Working the third shift means fewer people, Meeks said. “We’re not working close to each other.”

Meeks said she wouldn’t put a price on her health, but at her new job, the risks are lower and the pay higher — up from $9 to $11.50 an hour.

Wendi C. Thomas is the editor of MLK50: Justice Through Journalism. Email her at wendicthomas@mlk50.com and follow her on Twitter at @wendi_c_thomas.

Do you work at a warehouse or distribution center in the Memphis area? MLK50 and ProPublica want to hear from you.

• Call or text us: (901) 633-3638
• Email us: memphis@propublica.org

---

by J. David McSwane

The Transportation Security Administration ignored guidance from the Department of Homeland Security and internal pushback from two agency officials when it stockpiled more than 1.3 million N95 respirator masks instead of donating them to hospitals, internal records and interviews show.

Internal concerns were raised in early April, when COVID-19 cases were growing by the thousands and hospitals in some parts of the country were overrun and desperate for supplies. The agency held on to the cache of life-saving masks even as the number of people coming through U.S. airports dropped by 95% and the TSA instructed many employees to stay home to avoid being infected. Meanwhile, other federal agencies, including the Department of Veterans Affairs’ vast network of hospitals, scrounged for the personal protective equipment that doctors and nurses are dying without.

“We don’t need them. People who are in an infectious environment need them. Nobody is flying,” Charles Kielkopf, a TSA attorney based in Columbus, Ohio, told ProPublica. “You don’t take things for yourself. It’s the wrong thing to do.”

Kielkopf shared a copy of an official whistleblower complaint he filed Monday. In it, he alleges the agency had engaged in gross mismanagement that represented a “substantial and specific danger to public health.”

TSA has not required its screeners to wear N95s, which require fitting and training to use properly, and internal memos show most are using surgical masks, which are more widely available but are less effective and lack the same filtering ability.

Kielkopf raised a red flag last month about the TSA’s plan to store N95 respirators it had been given by Customs and Border Protection, which found more than a million old but usable masks in an Indiana warehouse. Both agencies are overseen by DHS. That shipment added to 116,000 N95s the TSA had left over from the swine flu pandemic of 2009, a TSA memo shows. While both stockpiles were older than the manufacturer’s recommended shelf life, the Centers for Disease Control and Prevention said that expired masks remain effective against spreading the virus.

Kielkopf and another TSA official in Minnesota suggested that the agency send its N95 masks to hospitals in early April, records show. Instead, TSA quietly stored many of them in its warehouse near the Dallas-Fort Worth airport and dispersed the rest to empty airports across the nation.

“We need to reserve medical masks for health care workers,” Kielkopf said, “not TSA workers who are behind an X-ray machine.”

The Number of Travelers Passing TSA Checkpoints Has Dropped to Historic Lows

The TSA didn’t provide answers to several detailed questions sent by ProPublica, but spokesman Mark Howell said in an email that the agency’s “highest priority is to ensure the health, safety and security of our workforce and the American people.”

“With the support of CBP and DHS, in April, TSA was able to ensure a sufficient supply of N95 masks would be available for any officer who chose to wear one and completed the requisite training,” the statement read.

“We are continuing to acquire additional personal protective equipment for our employees to ensure both their and the traveling public’s health and safety based on our current staffing needs, and as supplies become available,” TSA said.

A review of federal contracting data shows the agency has mostly made modest purchases such as a $231,000 purchase for gallons of disinfectant, but has not reported any new purchases of N95s.

An internal TSA memo last month said the surplus of N95s was expected to last the agency about 30 days, but the same memo noted that estimate did not account for the drastic decline in security officers working at airports. ProPublica asked how long the masks were actually going to last, accounting for the decreased staffing levels.

“While we cannot provide details on staffing, passenger throughput and corresponding operations have certainly decreased,” the TSA statement said.

The trade journal Government Executive reported this week that internal TSA records showed most employee schedules have been “sharply abbreviated,” while an additional 8,000 security screeners are on paid leave over concerns that they could be exposed to the virus.

More than 500 TSA employees have tested positive for COVID-19, the agency reported, and five have died.

The CDC has not recommended the use of N95s by TSA staff, records show, but that doesn’t mean workers who have or want to wear them can’t.

In one April 7 email, DHS Deputy Under Secretary for Management Randolph D. Alles sent guidance to TSA officials, urging them to wear homemade cloth face coverings and maintain social distancing. But the N95s, which block 95% of particles that can transmit the virus, were in notoriously short supply and should be “reserved” for health care workers.

“The CDC has given us very good information about how to make masks that are suitable, so that we can continue to reserve medical masks and PPE for healthcare workers battling the COVID-19 pandemic,” Alles wrote.

But two days later, on April 9, Cliff Van Leuven, TSA’s federal security director in Minnesota, followed up and asked why he had been sent thousands of masks despite that guidance.

“I just received 9,000 N-95 masks that I have very little to no need for,” he said in the email, which was first reported by Government Executive. “We’ve made N95s available to our staff and, of the officers who wear masks, they overwhelmingly prefer the surgical masks we just received after a couple months on back order.”

Minnesota Gov. Tim Walz had publicly asked that anyone who had PPE donate their surplus to the state’s Department of Health, Van Leuven said in the email to senior TSA staff.

“I’d like to donate the bulk of our current stock of N-95s in support of that need and keep a small supply on hand,” he wrote, adding the Minneapolis-St. Paul International Airport had screened fewer than 1,500 people the previous day, about a third of which were airport staff.

Van Leuven declined to comment, referring questions to a TSA spokesperson.

Later that day, Kielkopf forwarded the concerns to TSA attorneys in other field offices, trying to get some attention to the stockpile he felt would be better used at hospitals.

“I am sharing with you some issues we are having with n95 masks in Minnesota,” he wrote. “And the tension between our increasing supply of n95 masks at our TSA airport locations and the dire need for them in the medical community.”

Weeks went by, and finally, on May 1, Kielkopf wrote: “I have been very disappointed in our position to keep tens of thousands of n95 masks while healthcare workers who have a medical requirement for the masks — because of their contact with infected people — still go without.”

DHS did not respond to ProPublica’s questions about why it transferred N95 masks to TSA despite a top official saying they should be reserved for healthcare workers.

“So now the TSA position is that we desperately need these masks for the protection of our people,” Kielkopf said. “At the same time, most of our people aren’t even working. It’s a complete 180 that doesn’t make any sense.”

Do you have access to information about federal contracts that should be public? Email david.mcswane@propublica.org. Here’s how to send tips and documents to ProPublica securely.

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by Charles Ornstein and Lena V. Groeger

Nursing home residents have been among those hardest hit by the new coronavirus. In some states, more than half of the recorded deaths have been long-term care residents. Some of the homes have been cited for putting residents at “immediate jeopardy” of harm or death, our analysis showed.

And many of the affected homes have been previously written up for violating federal standards. That’s true in California, New Jersey and New York.

We’re updating Nursing Home Inspect to include more information about nursing homes across the country, including past problems with infection control practices, and which ones have had cases of COVID-19 among residents or staff.

We introduced this resource in 2012 as a way to search through tens of thousands of nursing home inspection reports to find problems and trends.

You can easily compare the nursing homes in your state based on how many times they have been cited for violating infection control protocols in the past three inspection cycles (roughly three years). We’ve also added data from The Washington Post on homes with COVID-19 cases. Nursing Home Inspect also allows you to sort by the number of health deficiencies cited by regulators; the number of serious deficiencies per home (that is, deficiencies in which patients were put in immediate jeopardy of harm); the amount of fines imposed; and how often the government has suspended payments to the home for new patients, another type of penalty.

Our data is from the U.S. Centers for Medicare and Medicaid Services (CMS), which has its own website called Nursing Home Compare. We’ve taken the information and organized it into an easy-to-use resource for families and residents, as well as researchers and other journalists.

Our site includes:

• State pages: Every state has its own section that allows you to compare all of the homes in a state on a variety of indicators.

• Individual nursing home pages: Every home has a section listing all of the health deficiencies identified within the past three survey cycles (roughly three years). The full text of these deficiency reports, if available, can be accessed via links from this page to CMS. Each home’s page also has ownership status — whether for-profit, government-run or nonprofit — and whether the home has been labeled by the government as a Special Focus Facility, meaning that it has many more problems than other homes. We’ve also labeled Special Focus Facility candidates, which meet the criteria to be a special focus facility but haven’t yet been designated as one. (We only include health deficiencies, not fire and safety violations, in this database.)

• State-by-state maps: The main page of the app shows how states compare in terms of the percentage of homes with at least one serious deficiency, the average fine paid by homes in the state, and the percentage of homes in each state with at least one infection-related deficiency.

• Top 20 Lists: We’ve listed the homes that have paid the most in fines in the nation and those with the highest number of serious deficiencies.

If homes violate federal standards, CMS may impose fines or suspend Medicare/Medicaid payments to the nursing home for new residents until the facility corrects the deficiency.

If problems persist or are not fixed, CMS can end its agreement with the nursing home. Additional details about CMS’ approach to enforcement can be found here.

Nursing Home Inspect continues to allow you to search through nearly 80,000 inspection reports by keywords, such as “choke” or “maggots,” to look for issues you care about. These search results can be sorted by date, city, state or severity of the deficiency.

Nursing homes are inspected on both a regular schedule and when there is a complaint. Inspectors typically work for state agencies paid by Medicare. If they find problems, known as deficiencies, they rank them on a scale of A to L, the most severe. The vast majority are either labeled D or E.

What you won’t find on these pages are self-reported quality measures for each home. Those can be found on Nursing Home Compare. We also don’t list the state sanctions imposed against homes because those are not centrally collected. For information on penalties within a given state, you should consult the state agency that regulates nursing homes. The federal government has a list of contacts available here.

When reading through inspection reports, it is a good idea to keep in mind the caveats we’ve outlined previously.

How We Combined Data Sources

To compile our app, we used different datasets: a listing of all Medicare-certified nursing homes, inspection violations and penalties, and deficiency report narratives.

We merged spreadsheets containing findings from routine inspections and those identified during complaint visits and kept only health violations, not fire safety violations.

We used each home’s unique identification code to match penalties imposed to the dates of their corresponding inspections so we could display that data together for each home. (We also noted some cases in which a penalty date did not have a corresponding inspection in the database.)

You can find the data we used on these sites:

• For a list of nursing homes: https://data.medicare.gov/Nursing-Home-Compare/Provider-Info/4pq5-n9py

• For penalties: https://data.medicare.gov/Nursing-Home-Compare/Penalties/g6vv-u9sr

• For health deficiency information: https://data.medicare.gov/Nursing-Home-Compare/Health-Deficiencies/r5ix-sfxw

• For deficiency report narratives (updated in April 2020): http://downloads.cms.gov/files/Full-Statement-of-Deficiencies-April-2020.zip

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by Robert Faturechi and Derek Willis

Sen. Richard Burr was not the only member of his family to sell off a significant portion of his stock holdings in February, ahead of the market crash spurred by coronavirus fears. On the same day Burr sold, his brother-in-law also dumped tens of thousands of dollars worth of shares. The market fell by more than 30% in the subsequent month.

Burr’s brother-in-law, Gerald Fauth, who has a post on the National Mediation Board, sold between $97,000 and $280,000 worth of shares in six companies — including several that have been hit particularly hard in the market swoon and economic downturn.

A person who picked up Fauth’s phone on Wednesday hung up when asked if Fauth and Burr had discussed the sales in advance.

In 2017, President Donald Trump appointed Fauth to the three-person board of the National Mediation Board, a federal agency that facilitates labor-management relations within the nation’s railroad and airline industries. He was previously a lobbyist and president of his own transportation economic consulting firm, G.W. Fauth & Associates.

Burr came under scrutiny after ProPublica reported that he sold off a significant percentage of his stocks shortly before the market tanked, unloading between $628,000 and $1.72 million of his holdings on Feb. 13 in 33 separate transactions. As chairman of the Senate Intelligence Committee and a member of the health committee, Burr had access to the government’s most highly classified information about threats to America’s security and public health concerns.

Before his sell-off, Burr had assured the public that the federal government was well-prepared to handle the virus. In a Feb. 7 op-ed that he co-authored with another senator, he said “the United States today is better prepared than ever before to face emerging public health threats, like the coronavirus.”

That month however, according to a recording obtained by NPR, Burr had given a VIP group at an exclusive social club a much more dire preview of the economic impact of the the coronavirus, warning it could curtail business travel, cause schools to be closed and result in the military mobilizing to compensate for overwhelmed hospitals.

The timing of Burr’s stock sales drew widespread outrage, allegations of insider trading, calls for his resignation and an FBI investigation.

Burr defended his actions, saying he relied solely on public information, including CNBC reports, to inform his trades and did not rely on information he obtained as a senator.

Fauth avoided between $37,000 and $118,000 in losses by selling off when he did, considering how steeply the companies’ shares fell in recent weeks, according to an analysis by Luke Brindle-Khym, a partner and general counsel of Manhattan-based investigative firm QRI. Brindle-Khym obtained Fauth’s financial disclosure from the Office of Government Ethics and shared it with ProPublica. Government forms only require that the value of stock trades be disclosed in ranges. After the February sales, the total value of Fauth’s individual stock holdings appears to be between $680,000 and $2 million.

Alice Fisher, Burr’s attorney, told ProPublica that “Sen. Burr participated in the stock market based on public information and he did not coordinate his decision to trade on Feb. 13 with Mr. Fauth.”

She did not respond to a question about whether Burr discussed anything he learned as a senator with Fauth or any other relatives.

A review of Fauth’s financial disclosure forms since 2017 show that he is not a frequent stock trader, but that he also had a major day of sales in August 2019.

On Feb. 13, Fauth or his spouse sold between $15,001 and $50,000 of Altria, the tobacco company; between $50,001 and $100,000 of snack food maker Mondelez International; and between $1,001 and $15,000 of home furnishings retailer Williams-Sonoma. He also sold stakes in several oil companies, which have been hit particularly hard, including between $15,001 and $50,000 of Chevron; between $1,001 and $15,000 of BP and between $15,001 and $50,000 of Royal Dutch Shell.

The finances of the Burrs and Fauths have intersected before. Federal Election Commission records show that Burr’s leadership PAC, Next Century Fund, has paid $120,348 since 2002 to his sister-in-law, Mary Fauth, Gerald’s wife, who serves as treasurer. The PAC has also paid $104,850 in rent and utilities over the same period to 116 S. Royal St. Partners, in which Gerald Fauth is a partner.

Do you have access to information about stock trading by Trump administration officials or members of Congress that should be public? Email robert.faturechi@propublica.org or reach him on Signal/WhatsApp at 213-271-7217. Here’s how to send tips and documents to ProPublica securely.

Update, May 6, 2020: This story was updated with new comment from Sen. Richard Burr’s attorney.

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by Michael Grabell

On Tuesday, March 31, an emergency room doctor at the main hospital in Grand Island, Nebraska, sent an urgent email to the regional health department: “Numerous patients” from the JBS beef packing plant had tested positive for COVID-19. The plant, he feared, was becoming a coronavirus “hot spot.”

The town’s medical clinics were also reporting a rapid increase in cases among JBS workers. The next day, Dr. Rebecca Steinke, a family medicine doctor at one of the clinics, wrote to the department’s director: “Our message is really that JBS should shut down for 2 weeks and have a solid screening plan before re-opening.”

Teresa Anderson, the regional health director, immediately drafted a letter to the governor.

But during a conference call that Sunday, Gov. Pete Ricketts made it clear that the plant, which produces nearly 1 billion pounds of beef a year and is the town’s largest employer, would not be shut down.

Since then, Nebraska has become one of the fastest-growing hot spots for the novel coronavirus in the United States, and Grand Island has led the way. Cases in the city of 50,000 people have skyrocketed from a few dozen when local health officials first reported their concerns to more than 1,200 this week as the virus spread to workers, their families and the community.

The dismissed warnings in Grand Island, documented in emails that ProPublica obtained under the state’s public records law, show how quickly the virus can spread when politicians overrule local health officials. But on a broader scale, the events unfolding in Nebraska provide an alarming case study of what may come now that President Donald Trump has used the Defense Production Act to try to ensure meat processing plants remain open, severely weakening public health officials’ leverage to stop the spread of the virus in their communities.

Ricketts spokesman Taylor Gage said the governor explained on the call with local officials that the plant would stay open because it was declared an essential industry by the federal government. Two and a half weeks later, as cases were rising among the state’s meatpacking workers, Ricketts, a Republican businessman whose father founded the brokerage TD Ameritrade, held a news conference and said he couldn’t foresee a scenario where he would tell the meatpacking plants to close because of their importance to the nation’s food supply.

“Can you imagine what would happen if people could not go to the store and get food?” he asked. “Think about how mad people were when they couldn’t get paper products.”

“Trust me,” he added, “this would cause civil unrest.”

In the last two weeks, small meatpacking towns across Nebraska have experienced outbreaks, including at a Tyson Foods beef plant in Dakota City, a Costco chicken plant in Fremont and a Smithfield Foods pork plant in Crete. With the governor vowing to keep plants open, the companies have only in recent days decided to close for deep cleanings as cases have grown to staggering levels.

In Grand Island, two hours west of Omaha, the consequences of the governor’s decision came quickly. The CHI Health St. Francis hospital, which has 16 intensive care beds, was soon overwhelmed. At one point in April, it had so many critical patients that it had to call in three different helicopter companies to airlift patients to larger hospitals in Lincoln and Omaha, said Beth Bartlett, the hospital’s vice president for patient care.

JBS workers felt the strain, too. Under pressure to keep the food supply chain flowing, some of the plant’s 3,500 workers, many hailing from Latin America, Somalia and Sudan, said they were told to report for work regardless. In a letter to the governor last week, Nebraska Appleseed, a nonprofit advocacy group, said a JBS worker had been told by his supervisor that if he tested positive, he should come to work anyway and “keep it on the DL” or he’d be fired. Some workers who’d been told to quarantine after being exposed told ProPublica this week that they were called back to work before the 14-day window recommended by the Centers for Disease Control and Prevention — even if they felt sick. One worker in the offal, or entrails, section recently fainted in the plant, they said, but was told he couldn’t go home.

Cameron Bruett, head of corporate affairs for JBS, said the company has worked in partnership with local officials to prevent the spread of the coronavirus and did not influence the governor’s decision to keep the plant open. He pointed to comments made recently by University of Nebraska Medical Center officials who toured the plant, who said JBS has put in place some “best practices,” including installing barriers on the meat cutting line, communicating new precautions in multiple languages and ensuring the proper use of masks.

Bruett said no one is forced to come to work or punished for calling in sick. “Such actions, if true, would be grotesque and a clear violation of our culture,” he said.

The emails obtained by ProPublica show that local health officials have traced 260 cases to the JBS plant. But that was nearly two weeks ago and almost certainly underestimates the total. Anderson, who directs the Central District Health Department, said she hasn’t had enough tests to do targeted testing of JBS employees and is only testing people when they’re symptomatic. In Grand Island and its surrounding county, 32 people have died from the virus. According to workers, at least one of those was a JBS employee.

Across the country, more than 10,000 COVID-19 cases have been linked to meatpacking plants, and at least three dozen workers are known to have died, a ProPublica review of news reports and government health data shows.

While cases in the worst hit urban areas like New York appear to have plateaued, the nation’s meatpacking towns have continued to see spikes. A few large outbreaks have dominated public attention, but COVID-19 cases have popped up in well over 100 plants in mostly rural communities. There the virus’s impact is magnified by the workers’ sometimes cramped living conditions, with multiple generations of immigrant and refugee families often residing together in apartments, houses and trailers.

Before Trump’s order, more than 30 plants had shut down at least briefly to increase cleaning and control the spread among their workforces. The various closures have cut beef and pork production by more than a third compared with last year, causing supply chain disruptions for some supermarkets and fast-food chains.

Some of those closures show the role public health officials have had in the actions of large meatpacking companies like JBS, which has beef, pork and poultry plants in 27 states.

In Colorado, Dr. Mark Wallace of the Weld County Department of Public Health and Environment and state health director Jill Hunsaker Ryan grew worried that that if the coronavirus spread at JBS’ Greeley plant, it would have a “devastating” effect on the community that “would quickly overwhelm the medical resources available in the hospitals.”

Unlike Nebraska, Colorado’s health officials eventually ordered the JBS plant to close. But documents obtained by ProPublica show the protracted debate that came before that decision, with JBS invoking the governor to question the formal closure order. By the time the order was issued, some public officials felt the virus had been given too big a head start.

Like Grand Island, Greeley officials were already hearing by the end of March that hospital emergency rooms were seeing a “high number of JBS employees,” according to an email Wallace sent April 1 to the plant’s occupational health director.

“Their concern, and mine, is far too many employees must be working when sick and spreading infection to others,” Wallace wrote, urging the plant to take additional safety measures.

Three days later, Wallace wrote a more detailed letter to JBS’ human resources director, Chris Gaddis, documenting the virus’s spread and threatening to shut the plant down if it didn’t screen employees and ensure they could work 6 feet apart.

But as days passed, the situation in Greeley didn’t improve.

“Want you to know my colleagues are not reassured by what I’m sharing about measures being implemented,” Wallace wrote to Gaddis. “‘The cat’s out of the bag’ is what all health care providers are saying — too many sick people already, too much spread already, etc.”

After nine days of back-and-forth, JBS agreed to close the plant and Hunsaker Ryan and Wallace issued a formal shutdown order. But negotiations seemed to stretch until the last minute, emails show.

After Hunsaker Ryan sent JBS the order on the afternoon of April 10, Gaddis appeared confused. “It is our understanding from the telephone conversation that the governor did not want this letter sent,” Gaddis wrote. “Please confirm it was properly sent.”

Bruett said the company’s impression was that the governor didn’t feel a formal order “was necessary given our voluntary decision to shut down.” But Conor Cahill, a spokesman for Gov. Jared Polis, said: “Of course the governor wanted the health order sent. The governor has been clear that JBS needs to be more transparent with their staff and the public about the situation at their plant.”

Notified of the shutdown by his staff, Greeley Mayor John Gates wrote in an email, “In my opinion, that should have happened a week ago for the health and safety of their employees.”

On Wednesday, the state announced the latest numbers on the JBS outbreak: 280 employees had tested positive for COVID-19, and seven of them had died.

The Grand Island beef plant opened in 1965 in a sugar beet farming area. In recent decades, the plant has drawn immigrants from Mexico and Central America, and more recently refugees from Somalia and Sudan. In a sign of the area’s shifting workforce, Somali residents have opened a mosque in the old El Diamante nightclub and a community center in the former Lucky 7 Saloon next to a Salvadoran restaurant named El Tazumal.

Members of those communities became among the first to hit the area’s medical clinics as the virus began to spread. By the last week in March, the Family Practice of Grand Island, where Steinke works, had opened a special respiratory clinic to handle COVID-19 patients. That week, six of the patients had come from JBS. But over three days from March 30 to April 1, the clinic saw 25 patients that carried JBS insurance, indicating they were either employees or their dependents.

Danny Lemos’ father was one of the first JBS workers to get sick from the virus in late March. The 62-year-old, who’d worked at the plant for a year, had developed a fever and a cough.

“One day, he was laying in the living room on a chair, wrapped up in a blanket, shivering,” Lemos said. “My mom takes his temperature, and he had a temperature of 105 and he was really having trouble breathing.”

His father was rushed to the hospital and put on a ventilator.

Within days, Lemos said he also started having trouble breathing and joined his father in the ICU. Lemos, 39, was put in a medically induced coma and given a 20% chance of living, he said.

Surprisingly, he said, he eventually recovered and was released from the hospital in late April. His father, Danny Lemos Sr., has been in the hospital for more than a month, most of the time on a ventilator, and is only now starting to recover.

Lemos said JBS should have taken better precautions.

“Shutting down right away, I think, probably would have helped a ton,” he said. “Do I think it would have kept everybody from getting sick? No, because those same people are still going to be out and about in the community. But just being so many people in one building, it was like a ticking time bomb.”

In an interview this week, Steinke said that it was hard to get the message across to JBS that more needed to be done.

“Even if they did not stop or shut down, if they would have put in better protections right from the start,” she said, “we would not have seen such a rapid rise in cases.”

At one point before the governor’s decision, the emails ProPublica obtained show, officials found language on the U.S. Department of Agriculture’s website that said local authorities could close a plant and the USDA would follow those decisions, potentially giving the health district some leverage.

“I guess I will send it to … HR there and maybe he will take us more seriously,” Anderson, the local health director, wrote in an email to the city administrator.

Under Trump’s executive order, that guidance has been reversed: The USDA could try to overrule local decisions if federal officials disagree.

That could pose a risk to the USDA’s own workforce of federal food inspectors, who work inside the plants to ensure the meat is safe to eat. According to the emails, some inspectors at the JBS plant also tested positive. Because inspectors sometimes monitor multiple sites, one inspector noted that she had recently worked in two other plants that have also had outbreaks, potentially spreading the virus within other plants.

“From my perspective,” temporarily closing the JBS plant “would have reduced the transmission,” Anderson said in an interview this week. “But if you shut down a plant and your 3,700 employees have nowhere to go, where are they going to go and how far is the spread going to be outside the plant vs. inside the plant? And if you end up going a month, what happens to their ability to feed their families?”

Anderson said that the “general feeling” she got from the call with the governor was that they needed to do more testing. So after the governor blocked the effort to close the plant, she continued to try to work collaboratively with JBS to encourage more testing of their employees.

In the emails, JBS officials said they were open to testing but repeatedly expressed concern about public disclosure of the results. “We want to make sure that testing is conducted in a way that does not foment fear or panic among our employees or the community,” JBS chief ethics and compliance officer Nicholas White wrote in an email to Anderson on April 15.

A week later, after the number of JBS cases was released by Anderson, Tim Schellpeper, president of the company’s U.S. beef processing operations, emailed her that he was worried about the amount of national attention it was attracting. “Have you given more thought to adding clarity/correction around this in your comments today?” he asked.

As JBS officials fretted about the optics of testing their employees, tensions within the families of the workers mounted. As the number of sick workers grew, the daughter of one worker, Miriam, said she was panicking about what would happen to her mother, who worked on the plant’s kill floor. At the end of every shift, she said, she called her mother to make sure she was okay.

“It was dreadful,” said Miriam, who asked that her last name not be used to protect her mother from retaliation. “It was just kind of living in fear waiting for the day she would have a fever. We knew it was going to happen because she’s a JBS employee. We didn’t think it was preventable anymore.”

Then, one day, she got a call from her mother, telling her that she had developed a fever and was being sent home.

“As she was changing in the locker room, she calls me and you can just hear the fear in her voice,” Miriam said.

Shortly after, her father tested positive for the virus too. Thankfully, she said, both her parents had only mild symptoms and have since recovered. But JBS and the governor should have done more, Miriam said.

“It just seemed like they were kind of careless,” she said. “I think it would have been a smart idea if not to close down the plant, to take more action to help the employees. They’re essential, but they need protection. They need to be kept safe.”

In the meantime, Ricketts has said that his approach of keeping the state “open for business” worked. And at a news conference Friday, he underscored the importance of the meatpacking industry to the state’s economy, proclaiming May as “Beef Month” in Nebraska.

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Neurological symptoms are common in patients with COVID-19, particularly if they have a severe infection, research published in JAMA Neurology suggests.

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Adults with non-valvular atrial fibrillation prescribed apixaban have a lower rate of ischaemic stroke and systemic blood clots compared with those prescribed rivaroxaban, according to a retrospective cohort study in Annals of Internal Medicine.

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Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned.

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All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen.

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Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine.

Newron will terminate work on its experimental Rett syndrome drug sarizotan after a complete failure in its pivotal STARS trial.

Sanofi and Regeneron’s Dupixent has become a popular treatment for atopic dermatitis and asthma. Now, a research team in Japan has discovered that IL-4 and its receptor—which Dupixent inhibits—could be promising targets for treating the eye disease age-related macular degeneration.

PTC Therapeutics is adding to its rare disease pipeline with a midstage biotech buyout with a low upfront payment tied in with stock and biobucks.

The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.

With social distancing in full effect, families have not only found themselves with a lot more time together, but a lot more time in front of their screens.

"Today, 75 years later, we are forced to commemorate alone, but we are not alone!" Germany's President Frank-Walter Steinmeier says, celebrating international unity in the post-war era.

The tech giant announces it is extending its previous work-from-home plans for most of its staff and will begin reopening offices this summer.

A major health agency fears a humanitarian crisis. Migrant workers are returning home from the hard-hit Dominican Republic. Medical equipment is in short supply. And social distancing is improbable.

By Monday at least 31 states will be open or partially open. This as President Trump pushed for the country to get back to work despite public health experts warning that it's too soon.

Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more focus on the need to rationalize and re-organize the post-acute sector, we have seen multiple industry leaders start to evolve their strategies.  I blogged yesterday about AccentCare’s interesting strategy in the...… Continue Reading

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading

After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […]

On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]