als United States Intervenes in False Claims Act Lawsuits Against Evercare Hospice and Palliative Care, Now Known as Optum Palliative Care and Hospice By www.justice.gov Published On :: Thu, 28 Aug 2014 14:28:12 EDT The United States has partially intervened against defendants in two whistleblower lawsuits in the Federal District Court for the District of Colorado alleging Evercare Hospice and Palliative Care submitted false claims for the Medicare hospice benefit. Full Article OPA Press Releases
als Georgia “Sovereign Citizen” Convicted of Filing False Liens Against Federal Officials By www.justice.gov Published On :: Fri, 5 Sep 2014 12:04:26 EDT A federal jury in Omaha, Nebraska, found a Pelham, Georgia, man guilty late yesterday of seven counts of conspiracy to file and filing false liens against two U.S. District Court judges, the U.S. Attorney for the District of Nebraska, two Assistant U.S. Attorneys and an Internal Revenue Service special agent. Full Article OPA Press Releases
als Justice Department Participates in Child Cyber Safety Night at Nationals Park, Saturday, September 6th By www.justice.gov Published On :: Fri, 5 Sep 2014 14:13:32 EDT Child Cyber Safety Night at the Ballpark is the latest effort by the Justice Department and its law enforcement and community partners to encourage parents to speak with their children about online and cell phone safety and provide prevention materials. Full Article OPA Press Releases
als Justice Officials Meet with Key Stakeholders on Launch of Elder Justice Website By www.justice.gov Published On :: Mon, 8 Sep 2014 16:47:02 EDT Earlier today, Associate Attorney General Tony West, Assistant Attorney General Stuart Delery for the Civil Division and members of the Department’s Elder Justice Initiative met with stakeholders in the field of elder abuse and financial exploitation to launch the Elder Justice website. Full Article OPA Press Releases
als Jose Padilla Re-Sentenced to 21 Years in Prison for Conspiracy to Murder Individuals Overseas, Providing Material Support to Terrorists By www.justice.gov Published On :: Tue, 9 Sep 2014 14:40:58 EDT John P. Carlin, Assistant Attorney General for National Security and Wifredo A. Ferrer, United States Attorney for the Southern District of Florida, announced today that U.S. District Judge Marcia Cooke re-sentenced Jose Padilla to serve 21 years in prison for his 2007 conviction for conspiracy to murder, kidnap and maim individuals in a foreign country; conspiracy to provide material support to terrorists; and providing material support to terrorists. Full Article OPA Press Releases
als Utah Resident Sentenced to Prison for Filing False Claims for Tax Refunds By www.justice.gov Published On :: Tue, 9 Sep 2014 17:12:07 EDT Stanley J. Wardle, of Spanish Fork, Utah, was sentenced today to serve 33 months in prison for filing false claims for income tax refunds, the Justice Department and Internal Revenue Service announced. Full Article OPA Press Releases
als Hewlett-Packard Russia Pleads Guilty to and Sentenced for Bribery of Russian Government Officials By www.justice.gov Published On :: Thu, 11 Sep 2014 17:41:04 EDT ZAO Hewlett-Packard A.O. (HP Russia), an international subsidiary of the California technology company Hewlett-Packard Company (HP Co.), pleaded guilty today to felony violations of the Foreign Corrupt Practices Act (FCPA) and was then sentenced for bribing Russian government officials to secure a large technology contract with the Office of the Prosecutor General of the Russian Federation. Full Article OPA Press Releases
als Wisconsin Pharmacist and Nevada Pharmacologist Charged with Smuggling Counterfeit Pharmaceuticals Using a Costa Rican Internet Pharmacy By www.justice.gov Published On :: Fri, 12 Sep 2014 14:42:05 EDT A Wisconsin pharmacist and a Nevada pharmacologist were arraigned on an indictment today in Federal Court in Central Islip, New York, before United States Magistrate Judge Gary Brown. The defendants are charged with conspiring to supply at least four million misbranded and counterfeit pharmaceuticals to an illegal Internet pharmacy based in Costa Rica that catered to U.S. customers. Full Article OPA Press Releases
als Florida Home Health Care Company and Its Owners Agree to Resolve False Claims Act Allegations for $1.65 Million By www.justice.gov Published On :: Wed, 17 Sep 2014 11:31:48 EDT A Plus Home Health Care Inc. and its owners, Tracy Nemerofsky and her father, Stephen Nemerofsky, have agreed to pay $1.65 million to the United States to settle allegations that A Plus paid spouses of referring physicians for sham marketing positions in order to induce patient referrals. Full Article OPA Press Releases
als Former Owner of Empire Towers Pleads Guilty for Fraudulent $7 Million Bond Scheme and Filing False Tax Return By www.justice.gov Published On :: Thu, 28 May 2015 13:20:24 EDT Misled More Than 50 Individual Investors Who Bought Bonds A former Queenstown, Maryland, resident pleaded guilty today to securities fraud and filing a false tax return Full Article OPA Press Releases
als Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic By feedproxy.google.com Published On :: Wed, 29 Apr 2020 13:00:12 +0000 By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications … Continue reading » Full Article Clinical Trials CATOSMS COVID-19
als Shot Roster: COVID-19 Vaccines In Human Trials By www.rttnews.com Published On :: Fri, 01 May 2020 00:58:48 GMT The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University. Full Article
als IMMU Gets Early FDA Nod, KNSA's PN Trial Meets Goals, MYOV In Good Spirits By www.rttnews.com Published On :: Thu, 23 Apr 2020 06:16:08 GMT Today's Daily Dose brings you news about FDA approval of Immunomedics' breast cancer drug; promising results from Kiniksa Pharma's prurigo nodularis trial; Mallinckrodt's regulatory catalyst; Myovant Sciences' phase III SPIRIT 2 study results and another disappointment in Parkinson's disease drug development space. Full Article
als Relmada Therapeutics (RLMD): Sending The Right Signals? By www.rttnews.com Published On :: Tue, 28 Apr 2020 10:46:01 GMT Shares of Relmada Therapeutics Inc. (RLMD) have gained 19 percent so far this year and trade around $37. Full Article
als ARDS In COVID-19 Battle, AKBA's Kidney Disease Drug Hits Goals, VAPO On A Roll By www.rttnews.com Published On :: Wed, 06 May 2020 05:15:35 GMT Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results. Full Article
als Will These Pharma Stocks Hit Or Miss Trial Goals? (ITRM, STRO, ENTA) By www.rttnews.com Published On :: Wed, 22 Apr 2020 10:51:24 GMT Let's take a look at the biotech/pharma companies that are slated to report clinical trial results this quarter. Full Article
als How States and Counties Can Help Individuals With Opioid Use Disorder Re-Enter Communities By feedproxy.google.com Published On :: Thu, 23 Apr 2020 07:00:00 -0400 At least 95 percent of individuals in state prisons will eventually return to communities. In fact, in a typical year more than half a million people do so, with many more coming from jails. A disproportionate share of these individuals have one or more chronic illnesses. Full Article
als Parry Nutraceuticals, Valensa Expand Microalgae Plans Through Joint Venture with Synthite Industries By feedproxy.google.com Published On :: Mon, 05 Feb 2018 20:57:00 GMT Valensa International announced today a joint venture agreement between Valensa’s parent company EID Parry and Synthite Industries Ltd., expanding plans to lead development and distribution of value-added microalgae extracts. Full Article
als The Health Care Practitioner Channel: Connecting Industry and Medical Professionals By feedproxy.google.com Published On :: Wed, 07 Feb 2018 14:57:00 GMT Selling directly to health care practitioners, supplement companies can foster open dialogue about their products; but, every regulation applies to products in this channel, too. Full Article
als 'Pioneering' study reveals collagen peptide changes during digestion By www.nutraingredients.com Published On :: Wed, 06 May 2020 16:00:00 +0100 Rousselot, the collagen-based ingredients producer, has revealed a new study which it says provides important answers surrounding the bioavailability of collagen peptides and the modifications they undergo during digestion. Full Article Research
als Consensus Fosters Sustainable and Inclusive Growth: APEC Senior Officials By www.apec.org Published On :: Sat, 07 Dec 2019 15:30:00 +0800 Members of the Asia-Pacific Economic Cooperation (APEC) will continue to work together towards more inclusive and sustainable growth, pledged APEC Senior Officials at the concluding event for Chile’s host year of APEC. Full Article
als Winner of 2019 APEC Photo Contest Also Wins Popular Choice Award By www.apec.org Published On :: Sun, 08 Dec 2019 12:24:00 +0800 The winner of the APEC Photo Contest 2019 has also won the most votes for the Popular Choice Award, announced the APEC Secretariat. Full Article
als Draft 2020 Chinese pharmacopeia includes hundreds of new pharmaceuticals By connect.raps.org Published On :: Thu, 07 May 2020 16:33:16 -0400 From : Communities>>Regulatory Open ForumHi everyone, As currently drafted, the 2020 Chinese Pharmacopeia, the benchmark publication on the safety and efficacy of pharmaceuticals legally available in China, includes 319 new entries. The publication includes more than 5,500 traditional Chinese and Western medicines. The official compendium of the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug legally marketed in China is published by the Chinese Pharmacopoeia Commission. It is designed [More] Full Article Discussion
als Movie Quotes for QA Professionals By polarisconsultants.blogspot.com Published On :: Tue, 26 Apr 2016 14:24:00 +0000 What if your favorite movie quotes were written for QA professionals? Would they be as memorable? We think so, but we’ll let you decide.In the fall of 2015, the internet was rife with tweets sporting the hashtag #ScienceMovieQuotes. Creative scientists repurposed their favorite movie quotes, gleefully infusing them with nerdy humor for the entertainment of their colleagues. Such a great idea was just asking to be stolen. And who are we to resist the siren call of piracy? So here’s our best attempt at making #QAmovieQuotes go viral.*“I’m gonna schedule an audit… he can’t refuse.” - Vendor Oversight Manager at Corleone Clinical “Batches? We don’t need to see no stinking batches!” - Said no GMP auditor ever.Auditee: “You want candor?” Auditor:” I want the proof.” Auditee: “You can’t access the proof!” (Not even A Few Good Men can view electronic source documents at some sites.)"Contemporaneous. You keep using that word.I do not think it means what you think it means." - Inigo Montoya, CCRP“I’ve always depended on the kindness of trainers.” Oh no. Who let Blanche talk to the Inspectors? “I love the smell of Wite-Out in the morning.” - Compliance Auditor, Fraud Division“Get busy complyin’ or get busy tryin’.” (Motivational poster at Shawshank Consulting)“Fecal transplants happen.” “Audits are like a box of chocolates…” [Sorry.] “That’s all right. He can call me ‘Sour’ if he wants to. I don’t mind.” Not every audit is like a trip to Magic Kingdom. Jr. Auditor: “How do you know it’s a glitch?” Sr. Auditor: “It looks like one.” It’s not witchcraft; it’s experience – the holy grail of the QA industry.“Of all the org charts in all the sites in all the world, you had to look into mine.” Qualification records are amiss at Casablanca Research Institute.And amiss is still amiss. [Again, sorry.] “What we’ve got here is a failure to refrigerate” Dr. Luke’s Hand might be Cool, but his Investigational Product isn’t. (Is the study drug supposed to be the Color of Money?) …And because the rhymes were just too good, we couldn’t resist…“What we’ve got here is a failure to investigate.” “What we’ve got here is a failure to remediate.” CAPA fail, Newman StyleIf you’re feeling creative, here are the American Film Institute’s 100 greatest movie quotes of all time. Please share your humor! (Fair warning – we took all the good ones.)By Laurie Meehan________________________________________________* Thanks to Robyn Barnes of MasterControl for this fun idea.Photo creditsBrando: User:Aggiorna / CC BY-SA-3.0, changes madeBadge: User:Dandvsp / Wikipedia Commons / CC BY-SA-3.0Nicholson: User:Nikita~commonswiki / CC BY-SA-2.5, changes madeShawn: Sam Felder / CC BY-SA-2.5, changes madeLeigh: Trailer Screenshot, A Streetcar Names Desire,1951, Public domainFreeman: User:FRZ / CC BY-SA-2.5, changes madeAladdin Chocolates: Hans Lindqvist, 2009, Public domainFlower: Walt Disney, Bambi, 1942, Public DomainDoune Castle: Keith Salveson / CC BY-SA-2.0Bogart: Trailer Screenshot, Casablanca,1942, Public domainNewman: Warner Bros. Entertainment, Cool Hand Luke, 1967, Public Domain Full Article Movie Quotes QA Quality Assurance
als Non-innovator biologicals in India: regulatory context and areas for improvement By www.gabionline.net Published On :: Mon, 04 May 2020 08:14:37 +0000 There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal. Full Article
als China publishes draft guideline for bevacizumab copy biologicals By www.gabionline.net Published On :: Fri, 08 May 2020 08:41:25 +0000 On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1]. Full Article
als Impact of COVID-19 on Regulatory Enforcement and Approvals By eyeonfda.com Published On :: Tue, 17 Mar 2020 12:00:24 +0000 The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading → Full Article Current Affairs FDA Image FDA Policy
als FDA Guidance on Clinical Trials During COVID-19 Pandemic By eyeonfda.com Published On :: Fri, 20 Mar 2020 12:34:27 +0000 Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading → Full Article Clinical Trials FDA Policy #COVID-19 #coronavirus #pharma
als Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2 By eyeonfda.com Published On :: Thu, 26 Mar 2020 10:48:35 +0000 Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading → Full Article Advisory Committee Prepapartion Approval Announcements Current Affairs FDA Policy #coronavirus #COVID-19 #COVID-19 #coronavirus #pharma
als Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research By eyeonfda.com Published On :: Wed, 01 Apr 2020 12:05:05 +0000 With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading → Full Article Current Affairs FDA Policy
als Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals By eyeonfda.com Published On :: Fri, 17 Apr 2020 15:45:55 +0000 In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading → Full Article Approval Announcements COVID19 FDA Policy #coronavirus #COVID19
als Indian manufacturers still deny drug quality problems and use same old rebuttals By searchingforsafety.net Published On :: Tue, 16 Sep 2014 11:25:27 GMT 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 [...] Full Article Uncategorized
als Trump Hasn’t Released Funds That Help Families of COVID-19 Victims Pay for Burials. Members of Congress Want to Change That. By tracking.feedpress.it Published On :: 2020-05-04T13:45:00-04:00 by Yeganeh Torbati ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. Democratic members of Congress are urging President Donald Trump to authorize FEMA to reimburse funeral expenses for victims of the coronavirus pandemic, citing ProPublica’s reporting about the administration’s policies. “Just as with all previous disasters, we should not expect the families of those that died — or the hardest hit states — to pay for burials,” said the statement issued Friday from Rep. Bennie Thompson, chairman of the House Homeland Security Committee, and Rep. Peter DeFazio, chairman of the House Transportation and Infrastructure Committee. “President Trump needs to step up and approve this assistance so FEMA can pay for the funerals of our fellow Americans so they can be buried in dignity. It is the least he can do.” ProPublica reported last week that Trump has yet to free up a pool of disaster funding specifically intended to help families cover burial costs, despite requests from approximately 30 states and territories. In lieu of federal help, grieving families are turning to religious institutions and online fundraisers to bury the dead. Trump has sharply limited the kinds of assistance that FEMA can provide in responding to the coronavirus pandemic. In an April 28 memorandum, he authorized FEMA to provide crisis counseling services but said that authority “shall not be construed to encompass any authority to approve other forms of assistance.” In a statement last week, a FEMA spokesperson said the approval of assistance programs “is made at the discretion of the President.” A spokeswoman for the White House’s Office of Management and Budget last week referred questions to FEMA, and she and two White House spokesmen did not respond to a request for comment on Monday. The administration’s failure so far to pay for funeral costs does not appear to be because of a lack of funds. Congress gave FEMA’s disaster relief fund an extra boost of $45 billion in the Coronavirus Aid, Relief and Economic Security Act in March. On Sunday, NJ Advance Media reported that as of April 25, FEMA had committed less than $6 billion in disaster relief for the coronavirus pandemic, and it has $80.5 billion in available disaster relief funds. The information was attributed to a FEMA spokesperson. FEMA did not respond to a request to confirm the figures. Calls for FEMA aid are likely to spike in the coming months, as hurricane season approaches and wildfire activity hits an anticipated peak. The amount FEMA reimburses for funeral expenses can vary, but a September 2019 report from the Government Accountability Office found that FEMA paid about $2.6 million in response to 976 applications for funeral costs of victims of three 2017 hurricanes, or an average of about $2,700 per approved application. If FEMA provided that amount for every one of the nearly 68,000 people in America reported to have died in the pandemic thus far, it would cost the government about $183 million. Do you have access to information about the U.S. government response to the coronavirus that should be public? Email yeganeh.torbati@propublica.org. Here’s how to send tips and documents to ProPublica securely. Full Article
als What Happened When Health Officials Wanted to Close a Meatpacking Plant, but the Governor Said No By tracking.feedpress.it Published On :: 2020-05-07T13:12:00-04:00 by Michael Grabell ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. 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. Danny Lemos’ father was one of the first JBS workers to contract COVID-19. Lemos, above, contracted it shortly thereafter and was put in a medically induced coma and given a 20% chance of living. (Courtesy of Danny Lemos) 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. Full Article
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