An East Side Bloods (ESB) gang member from Scottsdale, Arizona, was sentenced late yesterday to serve 30 years in prison for his role in the violent street gang, which operated on the Salt River Pima-Maricopa Indian Community reservation.

A former salesman at a prominent Los Angeles car dealership and another Southern California man were charged with odometer tampering, the Justice Department announced today.

Attorney General Eric Holder announced Monday that the Justice Department will launch a new series of pilot programs in cities across the country to bring together community representatives, public safety officials and religious leaders to counter violent extremism. The new programs will be run in partnership with the White House, the Department of Homeland Security, and the National Counterterrorism Center.

Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

The general manager of a Southern California ambulance company pleaded guilty yesterday in Los Angeles to conspiracy to commit Medicare fraud, conspiracy to obstruct a Medicare audit, and making materially false statements to law enforcement officers.

U.S. Attorney Peter Smith for the Middle District of Pennsylvania, Special Agent in Charge John Kelleghan for Philadelphia, U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) and Special Agent in Charge Sidney M. Simon of the New York Field Office, Office of Export Enforcement, U.S. Department of Commerce announced that yesterday Harold Rinko, 72, of Hallstead, Pennsylvania, appeared before Senior District Court Judge Edwin M. Kosik in Scranton and pleaded guilty to conspiracy to illegally export laboratory equipment, including items used to detect chemical warfare agents, from the United States to Syria, in violation of federal law

An Alabama real estate investor pleaded guilty yesterday for his role in a conspiracy to commit mail fraud related to public real estate foreclosure auctions held in southern Alabama, the Department of Justice announced today

A Northern California real estate investor has agreed to plead guilty for his role in bid rigging and fraud conspiracies at public real estate foreclosure auctions in Northern California, the Department of Justice announced

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

Preet Bharara, the United States Attorney for the Southern District of New York, announced that ROBERT STEWART, the father of former investment bank managing director Sean Stewart, pled guilty today to participating in a conspiracy to trade on inside information about several mergers and acquisitions announced between 2011 and 2014

A Georgia real estate investor pleaded guilty today for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Fulton and DeKalb counties, Georgia

ALEXANDRIA, Va

Lupin Pharmaceuticals Inc. (LUPIN, 500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis.

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.

Ocean Spray Cranberries, Inc. is recalling Pink Lite Cranberry Juice Drink citing potential for undeclared sulfites, the U.S. Food and Drug Administration said in a statement. The recall involves a single production lot of 5.5oz cans of the drink with lot number MH0030LPK4 and Best Before Date of 24JAN21. The product is sold in boxes containing six 5.5oz cans. They were distributed to retail

Individuals with opioid use disorder (OUD) struggle to get effective care: Of 2 million Americans with the illness, only 26% receive treatment. Now, as the coronavirus pandemic presents an added strain on the U.S. health care system, it is creating greater hardships for those seeking OUD treatment.

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.

The most effective therapy for people with opioid use disorder (OUD) involves the use of Food and Drug Administration-approved medications—methadone, buprenorphine, and naltrexone. Despite evidence that this approach, known as medications for opioid use disorder (MOUD), reduces relapse and saves lives, the vast majority of jails and prisons do not offer this treatment. This brief examines what...

More than 2 million Americans suffer from opioid use disorder, but only about 25% of people receive any sort of care. For many, inpatient treatment often means leaving a job and loved ones behind to seek recovery.

The treatment gap continues to be an obstacle in addressing opioid use disorder (OUD) in the U.S. In 2018, an estimated 2 million Americans had OUD but only about 26% received specialty addiction treatment.

This blog was written by Ankit Mahadevia, CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC.  If CEOs have empowered their teams effectively, they have three roles during times of rapid change: Motivator in chief

The post The Balancing Act: Taking A Systematic Approach To Hard Decisions In Times Of Rapid Change appeared first on LifeSciVC.

Venture capital is a long investment cycle business, and never before has that been so clear as now in the face of the ongoing COVID pandemic. Even with the unprecedented public equity market volatility, venture investing into private biopharma companies

The post Booming VC-Backed Biopharma: Strong Market Despite Pandemic appeared first on LifeSciVC.

Another leading athlete has joined Arla Foods Ingredients’ growing number of brand ambassadors for Lacprodan® HYDRO.365.

Valensa International announced Non-GMO Project has been awarded to Valensa’s Organic Spirulina, Chlorella and Microalgae products.

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.

La Serena Roadmap for Women and Inclusive Growth to bolster progress

From : Communities>>Regulatory Open Forum
Dear Roy, You do not mention any important functions of the syringe/applicator, other than the Primary Packaging function for which you have identified testing to assess impact. The determination of these functions (e.g. deliverable dose or dose accuracy) could provide important testing to verify that no impact on performance. Also, an assessment on the impact of the change on the usability could be required (particularly if the ergonomics/forces change) or patient risk would be prudent, which [More]

From : Communities>>Regulatory Open Forum
Dear Lee & Spyros, Many thanks for your invaluable advice - really appreciate your time in considering and providing deep insight. Kind regards, Roy Jamieson (BPharm Hons) Regulatory CMC Consultant

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]

You know you need a computer systems audit, but that’s literally the extent of what you know.
Has this ever been you?

Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply. Terms like “cloud computing” make you feel slightly queasy. You’d rather get a root canal than discuss “distributed processing.” Your expertise is in manufacturing. Or clinical research. Or non-clinical lab operations. And somehow it’s your job to make sure an effective and properly-sized system audit is conducted. Great.



Yet your Quality Assurance colleagues -- whether they’re from your internal QA department or an external compliance company -- need your input. They need to understand what software is being purchased, what services are being contracted, how and where components of the system are being implemented, and how the system will be used.

The good news is that the QA auditors can help you. They know that FDA favors a risk-based approach to validation and Part 11 implementation, and they even know what that means. They love to talk about configuration management and change procedures. They love gathering evidence that demonstrates your system works correctly and is in a state of control, and they know what rocks they should look under to find and fix vulnerabilities.

What follows are examples of the types of information you need to convey to QA – and that they should be asking you about – to properly size and scope an audit.

How do You Plan to Use the System?

Suppose you need to audit the supplier of a new Document Management System. The first thing an auditor would need to understand is how you plan to use the system. How mission critical are the documents you’re looking to store?  Are they covered under regulatory scope?  Maybe you plan to use the system as a collaboration environment for developing new SOPs. That would require a relatively low level of scrutiny, especially if you only plan to print out the finalized documents for wet ink signature. (As a point of comparison, if you plan to use the system to finalize SOP approval, the auditor would need to check that Part 11 requirements for electronic signatures are properly implemented.) What if the Document Management System will be housing critical GxP documents, such as Trial Master Files, Master Schedule Sheets, or Master Batch Records? In these cases, the validation would have to be far more thorough, and Part 11 electronic record features, such as audit trails and archiving functionality, would have to be implemented and verified.

Here’s another “use” example. Similar to the term “Document Management System,” the term “Analytics System” does not tell the whole story. From a business perspective, study start up (SSU) metrics may be vital for sponsors and CROs to collect and analyze. But since they have no regulatory impact, the FDA would not require an SSU analytics system to be validated. (That doesn’t necessarily mean you might not want to, though.) On the other hand, a system that performs statistical analysis on study data for regulatory submission is about as critical as it gets, and would require thorough validation and Part 11 implementation. Other analytics systems, such as dashboards that pull data from critical systems, might fall somewhere between these two extremes.

What is the Vendor Providing? And How? And Where?

If you need to audit a complex system, the questions QA will ask you will go beyond system use. The auditors will need to understand the combination of software and services the vendor is providing, and where the software and data reside.

• Does the software and data reside internally at your company or does the vendor provide a hosting service?
  If the vendor is hosting, the auditor needs to tour the facilities and review SOPs and records to evaluate physical security, staff training, environmental controls, backup procedures, disaster recovery plans, data retention, computer infrastructure, and change control.
  
  
• Does the hosting vendor own its own servers or does it, in turn, outsource that function to a 3rd party hosting company, (possibly even in the cloud)?
  If the hosting is outsourced, ideally an auditor would be able to visit the hosting site. Failing that, the auditor would ask questions about the vendor’s qualification processes and review SOPs that govern vendor selection/management procedures. If the vendor outsources other services beyond hosting, those services might need to be considered, as well.
  
  
• Is the vendor providing any other services?
  Many EDC vendors will provide study-specific services such as screen development and data entry validation edits. Auditors would need to review SOPs for providing these services and understand how the vendor tests and manages modifications to these components as the study proceeds.
  Sometimes computer systems vendors provide ancillary services, such as help desk functions and user account management. That would mean additional SOPs and training records for the auditor to look through.

Other Considerations

There are many. For example, where are you in the product life cycle? You ask different questions about a new system than you would about one that has been operating for a few years. Is the product Commercial off-the-shelf (COTS) or highly customized? COTS systems vendors often have their own validation package which auditors would review, and then ensure proper operation in the sponsor/CRO’s specific environment. A highly customized or custom-built system would require a more extensive validation process.


The Take Away

CSV/Part 11 audits will never be standardized, cookie cutter type activities; there are simply too many factors -- in too many combinations -- to consider. You want your QA efforts to be worth the money you spend and be able to answer the questions FDA says you need to be asking. If you’re unsure how to do that, that’s ok. Other people know, as long as you can help them understand how you plan to use the system, what software and services are being supplied, and how components of the system are being implemented.

In case you missed it, our previous post was Notes 2 Fix Your Notes 2 File.
_______________________________________________
Many thinks to Lisa Olson for sharing her insights with me.

When I was a teenager, my grandfather would invite my new boyfriends to run short, pointless errands with him, just so he could watch them drive. He said he could tell a lot about a boy’s character simply by observing his actions behind the wheel. Did he stay under the speed limit? Did he use his signal when he was switching lanes? Did he slow down when children were playing near the road? If so, it was a good sign that the boy was generally a careful and attentive fellow. If not, it was an early indication of reckless tendencies, and I would do well to be on my guard.

What does this have to do with PI oversight?



As Sponsors and CROs, you’re sometimes forced to make site selection decisions based on a limited set of criteria that you deem to be – hope to be – reflective of the site as a whole. In a short space of time, you need to assess a PI’s commitment to study oversight. On what should your pre-study “test drive” focus to help you gauge the level of care and attention a prospective PI will devote to your study?

We have some suggestions.


Assessing Attention to Detail
Any GCP-compliant site can produce a set of current CVs, job descriptions, and training records; they’re essential documents. But the most attentive sites are able to show you more than a collection of records during your pre-study visit with them. These sites keep a complete, organized set of uniform records and can describe their tight system for maintaining it. All documents for each staff member are found in dedicated tabs inside a records binder, or are equally well-organized in an electronic records system. All CVs are in a standard format so Sponsors can easily compare qualifications across individuals. Every document is current; CVs are up to date, and there’s a system in place to track which medical licenses are expiring when. Training records are comprehensive and include training on GCP regulations, site SOPs, and EMRs.

This is not sexy stuff. That’s why it’s a good indicator of PI oversight.  A site that is disciplined enough to keep such tight control over its personnel records is likely to carry that control into all aspects of trial execution.

Assessing Commitment to Protocol Compliance
During site initiation visits, Sponsor/CRO staff is on site to conduct protocol training; all study sites start off the same in this respect. But protocol amendments are inevitable, and sometimes – though nobody’s happy about it – frequent. You need assurances that a site’s response to each amendment will be swift, well-coordinated, and deliberate. Ask the prospective PI, “What procedures does your site follow for managing protocol amendments?”

The A answer:
“When a protocol amendment arrives, we convene a special team meeting to review the changes and discuss their effects. For example, if additional safety tests are required, the team discusses who shall be delegated to perform them? Do we have adequate time scheduled into the visit for any additional procedures the amendment requires? How will I be demonstrating oversight of any new test results? Once we’ve asked and answered these kinds of questions, we document attendance at the meeting, record assignments of delegated duties, and publish meeting minutes.”

The F answer:
“I email the amendment out to my team. I assume they’re all adults and know how to read.” (#TrueStory)

Just Ask
After reviewing essential documents and protocol amendment procedures, you should ask about other PI oversight mechanisms the site has in place. A good prospective site might tell you the PI holds biweekly meetings to review the items raised during monitoring visits. A PI may block out time at regular intervals to review adverse events and other study documents, and sign off on labs. A PI who values staff excellence may actively encourage and support Study Coordinator certification; some may even require it after an initial period of employment. In the past, we’ve worked with sites that have established internal Quality Control procedures, some maintain CAPA programs, and others conduct mock inspections.

There’s a wide variety of responses that can give you confidence a prospective PI is committed to running your study in a constant state of control. Whatever oversight measures are discussed, remember to ask how they will be documented, so during the study you’ll be able to verify that each activity is being consistently carried out.

Epilogue
After running an errand with a boy I met at college, my grandfather happily reported back to me, “He didn’t roll through a single stop sign coming down Green Hill Road. He’s all right, that one.”

My grandfather, a retired police detective for the city of Pittsburgh, knew how to read a person. That boy and I celebrated our 30th anniversary last month.

I was a child bride.

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by Adriana Gallardo, ProPublica, and Ariel Goodman for ProPublica

They’ve gotten to know New York City in a way many have not, through the low-wage work of cleaning its skyscrapers, serving its restaurants and crisscrossing its streets on bicycles, through long subway rides very early in the morning and very late at night. The saying goes: You’re not a true New Yorker unless you’ve lived here for a decade. They’ve done their time and felt a deep sense of belonging in this city of immigrants.

But, in the epicenter of a pandemic, the undocumented have never felt more alone.

They are losing loved ones but do not qualify for city funding to help bury them. They are getting sick but hesitating to get tested or go to the hospital, balancing their fear of the virus with their fear of exposure to immigration authorities. They are worried about supporting their families abroad as well as those who live with them, weighing whether to keep working perilous jobs or to stay home and somehow keep food on the table.

They’ve experienced separation, but not like this — out in the world, in a skeleton crew, wearing a mask to deliver food to closed doors; in cramped apartments, sectioned off, in an attempt to quarantine. They are divided across national borders as family members die, praying novenas on Google Hangouts. Their bodies cannot be buried, intact, where they were born; they move from hospital bed, to refrigerated truck, to incinerator.

ProPublica interviewed two dozen undocumented Latino immigrants and their families about their experiences with death, illness and survival. Some spoke on the condition of anonymity, afraid of being targeted. Others allowed us to use their first names or the full names of their family members who died.

One kitchen worker from the Bronx worked in the World Trade Center two decades ago. “We used to fill the back elevators of those towers,” he said. He lost friends on Sept. 11, 2001, who were not identified or acknowledged among the dead because their names did not match those on record or their families were unable to claim the bodies.

He and others spoke to ProPublica because this time they wanted their experiences to be counted as part of the story of their city, overtaken by a virus.

Barriers to a Proper Burial

Adrian Hernandez Lopez, 38, never planned to stay in New York City. His 15 year stint here was dotted with visits to his family in Mexico, for the baptism of his son, who is now almost a teen, and to check on the house he had been sending his paychecks to build.

He and brother worked at an Italian restaurant in Times Square. “We were always together,” his brother said. They crossed the border together and, years later, commuted together from Queens to midtown Manhattan.

The last time they spoke by phone, Lopez waited in agony in a hard chair at Elmhurst Hospital, breathing in oxygen from a machine. He was transferred to Woodhull Hospital in Brooklyn. One day later, the father of two wound up in a vegetative state.

He died on April 2. His mother, who lives in Allende, a small village in the state of Puebla, wants him buried there, alongside two babies she lost just after birth.

He can’t be traditionally buried, despite the strong Mexican custom. More than 400 Mexican migrants are known to have died of COVID-19 in the New York area, but for health reasons, Mexico will only accept their bodies if they are cremated.

In place of seeing the body one last time, Lopez’s brother was sent photos by the funeral home, which will hold the cremains while the family figures out how to get them to Mexico.

The Mexican Consulate pledged financial aid to the families of nationals who died of COVID-19 complications, but it has been slow to materialize. According to Lopez’s brother, they’ve been asked to follow guidelines to receive a reimbursement. The Consulate General’s office in New York said it was not authorized by the Mexican government to give interviews at the time of our request for comment.

The city of New York provides burial assistance, but it requires a Social Security number for both the deceased and the person requesting funds. City officials say they are limited by federal and state law in the help they can offer. “We are exploring every possible option to ensure that all New Yorkers, regardless of immigration status, are able to bury their loved ones in the way they feel is most fitting,” city spokesperson Avery Cohen said.

Two members of the City Council have called for an emergency fund to provide assistance to all low-income families, including the undocumented.

“One of the most devastating calls I’m regularly getting is from people who can’t afford to bury their loved ones and aren’t eligible for any assistance,” Council Member Francisco Moya said in a release. “That’s simply not acceptable.”

Lopez’s family is one of several raising money for the transport and burial of their loved one who died in the United States.

As he tries to figure out how to send Lopez home, his brother sits in the small apartment they shared in Queens, with his wife and 6-year-old daughter, listening to the sirens that have become a constant reminder of their loss. He and his wife have been out of work for a month. They don’t know how they will pay the rent.

Deterred From Seeking Care

More than a dozen undocumented people told ProPublica that when they got sick, they stayed home, deterred from seeking care by the worry that they would not get it if they tried. They faced the same obstacles as everyone else in New York, where hospitals were crowded and unsafe, and feared additional ones involving their immigration status.

Fani lives in East Harlem. Over the last 18 years, she’s worked at a laundromat and a factory, a restaurant and as a babysitter. When she and her husband got sick they called 311. She said the voice on the other end confirmed their COVID-19 symptoms and told them to stay home unless they couldn’t breathe.

“They said there were no beds, no respirators. We healed each other as best we could with soups, teas and Tylenol,” she said.

Sonia, who became ill with COVID-19 symptoms almost three weeks ago, was afraid to go to the hospital. “I knew several people who went into the hospital with symptoms and they never came back,” she said. “That was my fear and why I decided to not go in. I preferred to isolate myself at home, with a lot of home remedies and hot teas.”

Multiple people said they knew hospitals had limited resources and worried they would be placed last in line for care because they were undocumented. “They’re going to let us die,” one man told his brother. A woman named Yogi in the Bronx said, “It might not be that they don’t want to treat us, maybe there weren’t enough supplies.”

Stories rippled through the Latino community about those who had difficulty getting care and those who could not be saved. According to a recent poll of voters in New York City, more than half of Latinos there said they know someone who died, the highest percentage of any group asked.

They hear stories about people like Juan Leonardo Torres, a 65-year-old retired doorman who knew someone on every corner of Corona, Queens. Unlike the others, Torres, from the Dominican Republic, was a citizen. Even so, he grew discouraged when he tried to get care.

Within one week at the end of March, Torres had gone from feeling slightly ill to experiencing difficulty breathing and fevers that his wife Mindy tried to manage using herbs and other “remedios caseros,” or home remedies. She and her five sons who lived with them finally persuaded him to go to Long Island Jewish Medical Center Forest Hills, just a five-minute drive from the house.

When Torres arrived, he told his family there were not enough seats in the crowded emergency room. He gave his chair up to an older woman and stood for hours as staff connected and disconnected him to an oxygen tank.

Fifteen hours later, on a drizzly night, Torres appeared at the door of the family home. It was 2:30 a.m. He had made the walk alone and declared in Spanish, “For no reason do I want to go to the hospital to die like a dog.”

He spent the next three days quarantined in his son’s room, where he died.

As the family waited six hours for his body to be retrieved, his wife sat in the living room “like a statue.”

Calculating Survival

Unable to qualify for relief programs like unemployment and stimulus cash, undocumented people are faced with the difficult choice of working dangerous jobs or running out of the money they need for essentials like food and housing.

“The little we have goes to food,” said Berenice, who suffers from kidney problems and whose son struggles with asthma. She’s been home for weeks along with her husband Luis, who before the pandemic worked at a cab company.

“Yes, we need money, but there is also our health,” Berenice said. “We have family who are sick and friends who died. We are trying to survive.”

Luis has lived in New York for 18 years, working his way up from delivering pizza on a bicycle to owning a cab. He worries about exposing his wife and son. “I just want this to pass and we’ll see about starting over again,” he said.

Adan lives in the Bronx with his two teenage sons, who were born in New York City, and his wife. She cleaned homes. He worked in a restaurant in East Harlem. Neither are working and both overcame COVID-19. “The little money we had went to pay last month’s rent,” he said. “I don’t know what to do, we just want to work.”

He said his landlord always comes looking for the rent in person. He told “el señor” that he’s spending all his money on food. The man gave him flyers about unemployment, but Adan knows he won’t qualify. “Me las voy a ver duras,” he said. He’s going to see hard times. He said he has lived in the same building for 11 years and has never missed a payment. Even though he can’t be evicted now, he said, “the debt will be there.”

Adding to the pressure, for some, is that they also work to support family members in their home countries, who count on the money they send.

One delivery worker in Queens sends $400 to Mexico every two weeks to help his son, who studies biomedicine at a university in Puebla; that helps him cover what he needs for school, including rent and transportation. He sends another $300 each month to his elderly mother.

He said he remains one of only a few bicycle delivery workers at his diner who are still on the job, and he is seeing more orders than usual. He’s always worked six days a week, but this past month was so busy, he couldn’t stop to eat lunch or take breaks.

He would much rather be outside than at home, but the streets feel tense. “I feel strange not seeing anyone or saying hi anymore, but I think it’s much better this way,” he said. “I understand why people are afraid.”

Even though he doesn’t see them in the buildings he visits, customers have been conscious about leaving tips in envelopes. He feels grateful as he passes the long lines in Queens of those waiting for free food. It makes him sad to know how many need it now.

He rents a room in an apartment he shares with three other men who have all lost their jobs. One was in construction, the other two in restaurants. He takes precautions to keep them safe when he comes home, including changing his clothes before coming in. “It would be irresponsible not to,” he said.

He hopes the rules of social distancing, and his mask and gloves, will protect him. “I’m not scared,” he said. “If you are afraid all the time, you will get sick faster.”

---

by Nina Martin and Bernice Yeung

When Alfredo Pabatao told his family that he had helped move a suspected coronavirus patient through the hospital where he’d worked as an orderly for nearly 20 years, he didn’t make a big deal out of it. “My parents are the type of parents who don’t like to make us worry,” his youngest daughter, Sheryl, recalled. But Sheryl was concerned that her father’s vulnerabilities weren’t being given more consideration as he toiled on the pandemic’s front lines in hard-hit northern New Jersey. “Why would they let a 68-year-old man with an underlying heart condition … transport a suspected COVID patient when there’s younger transporters in the hospital who could do it?”

Sheryl’s mother, Susana, was an assistant nurse in a long-term care facility where she often pulled double shifts, saving money for her annual trips back to the Philippines. At 64, she wasn’t much younger than the elderly patients she helped bathe and feed, and she had diabetes, which increased her risk of severe complications if she got sick. The nursing home wasn’t providing adequate personal protection equipment, Susana reported, so Sheryl brought home a stash of surgical masks for her mother to wear on the job. That didn’t go over well with Susana’s managers, Sheryl said: “They gave her a warning, saying she shouldn’t be wearing that. … She was really mad.”

Alfredo fell ill first, his symptoms flaring on March 17. Susana soon developed a fever. The couple had grown up on the same street in Manila and shared a romance that reminded their daughter of a telenovela; after 44 years of marriage and five children, they were all but inseparable. “Where mom goes, my dad goes. Where my dad goes, my mom goes. That’s the way they are,” Sheryl said. The day Alfredo was admitted to the ICU, his heart failing, Susana checked into the same hospital. They died four days apart.

Filipino American medical workers have suffered some of the most staggering losses in the coronavirus pandemic. In the New York-New Jersey region alone, ProPublica learned of at least 30 deaths of Filipino health care workers since the end of March and many more deaths in those peoples’ extended families. The virus has struck hardest where a huge concentration of the community lives and works. They are at “the epicenter of the epicenter,” said Bernadette Ellorin, a community organizer.

Some of the largest Filipino enclaves on the East Coast are in the New York City borough of Queens and northern New Jersey — the very places now being ravaged by COVID-19.

Filipinos are on the front lines there and across the country, four times more likely to be nurses than any other ethnic group in the U.S., experts say. In the New York-New Jersey region, nearly a quarter of adults with Filipino ancestry work in hospitals or other medical fields, a ProPublica analysis of 2017 U.S. census data found. The statistic bears repeating: Of every man and woman in the Filipino community there, one in four works in the health care industry.

“So many people can rattle off five, 10 relations that are working in the medical field,” said filmmaker Marissa Aroy, whose most recent documentary is about Filipino nurses. Her parents were registered nurses in California, and various relatives are in health care professions, including a cousin who works in a rehab center in the Bronx and recently recovered from COVID-19. “Think about all of those family members who are going to be affected,” Aroy said. “We’re talking about huge family structures here.”

The scale of the trauma and the way it is unfolding are “similar to times of war,” said Kevin Nadal, a professor of psychology at John Jay College of Criminal Justice and The Graduate Center of the City University of New York who has written extensively about Filipino American psychology and culture.

The majority of the reported deaths have involved nurses, including Susan Sisgundo and Ernesto “Audie” DeLeon, who worked at Bellevue Hospital in New York City, and Marlino Cagas, who spent 40 years as a pharmacy tech at Harlem Hospital before embarking on a nursing career at the age of 60. A handful, including Jessie Ariel Ferreras, a family practitioner in Bergen County, were doctors. Others worked in support roles, like Louis Torres, 47, the director of food services at a nursing home in Woodside, Queens, and his 73-year-old mother, Lolita, or Lely, a clerk at a nearby hospital. They lived together and fell sick around the same time, both developing pneumonia. Lolita died on April 7, her son, the following day.

Don Ryan Batayola, a 40-year-old occupational therapist, was from a big, tight-knit family and lived in Springfield Township, New Jersey. He is believed to have caught the virus from a patient and was rushed to the hospital on March 31. By April 4, he had improved enough to FaceTime with his wife, also an occupational therapist who was sick and self-isolating at home, their children sheltering with relatives. Then, an hour later, he went into cardiac arrest.

One of the most wrenching aspects of the epidemic is the sense of disconnection and helplessness in a community that stakes its economic well-being on providing care and comfort and cherishes its closeness. So many members of Batayola’s extended family are health care workers, “we could almost open our own hospital,” said his oldest sister Aimee Canton, an oncology nurse in Northern California. But to protect each other, they’ve had to remain apart, with no idea when they’ll be able to come together again. “It’s so sad when you’re a nurse,” Canton said, “and you can’t even help your own family.”

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Almost all the deaths of Filipino American health care workers that ProPublica found involve people, like the Batayolas, who immigrated during the 1970s to 2000s, when critical shortages created opportunities for medical personnel with the right training.

But the story of Filipino nurses in the U.S. goes back much further, to the end of the Spanish-American War in 1898, when the Philippines became a U.S. territory, said Catherine Ceniza Choy, a professor of ethnic studies at the University of California, Berkeley, and author of “Empire of Care: Nursing and Migration in Filipino American History.” One legacy of the colonial era is a network of hundreds of Americanized nursing schools that eventually produced tens of thousands of caregivers a year, making the country “the leading exporter of nurses in the world,” Choy said.

Nursing offered an escape route from economic and political instability and a path to the middle class for those who had few other options. It also appealed to deeply held cultural values: “kapwa,” Tagalog for “a feeling of interconnectedness to all people, putting others before yourself and taking care of the community,” Nadal said, and “utang ng loob,” the idea that people owe a debt to each other and to those who came before.

Most nurses trained in the Philippines who sought work abroad hoped to end up in the U.S. (They also migrated in large numbers to the Middle East and the U.K.) American immigration policies ebbed and flowed depending on labor shortages and political expediency. In the first third of the 20th century, the numbers of Filipino nurses were small; most workers from the islands were sent to the fields of California and the plantations of Hawaii. Then, in the wake of the Great Depression, Filipino immigrants were capped at just 50 per year, rising to 100 after World War II.

After the war, U.S. nursing shortages grew acute. Even as the passage of Medicare and Medicaid made health care more accessible to the elderly and poor, the rise of the feminist movement, which opened up professional opportunities for American women, made caregiver work less appealing, Choy said. The Immigration Act of 1965 swept aside the long-standing system of country-based quotas, instead giving preference to immigrants with professional degrees. Tens of thousands of Filipino nurses answered the call.

Caregivers on the Front Lines

The scale of losses among Filipino Americans from COVID-19 is only beginning to sink in. Clockwise from top left: Don Ryan Batayola, an occupational therapist; Alfredo Pabatao, a hospital orderly; Susan Sisgundo, a neonatal ICU nurse; Ernesto “Audie” DeLeon, a hospital nurse; Susana Pabatao, a long-term care nurse; Daisy Doronila, a correctional facility nurse.

Many ended up at inner-city and rural hospitals that had the greatest difficulty recruiting staff, often working the least desirable jobs and shifts, including, in the 1980s and ’90s, on the front lines of the AIDS epidemic. It was part of a historical pattern, said Nadal, of “immigrants doing a lot of the dirty work that people don’t want to do... being painted as heroes, when in reality they are only put in these positions because their lives are viewed as disposable.”

Yet it was a template for economic security that many of their American-born children and grandchildren embraced. “It’s like any kind of family dynamic,” Aroy said. “You see your parents do the job. And so then you know that that’s accessible to you. As a second- generation kid, I always knew that was a path for me if I wanted it.”

Today, people of Filipino ancestry comprise about 1% of the U.S. population but more than 7% of the hospital and health care workforce in the United States — nearly 500,000 workers, according to census data. They find themselves fighting not just a potentially lethal illness, but the scapegoating stoked by President Donald Trump and supporters who have taken to calling COVID-19 the “Chinese virus.” Since late March, civil rights organizations have received nearly 1,500 reports of anti-Asian hate incidents, mostly from California and New York, including against Filipino Americans.

“This anti-Asian racism that’s happening right now,” Aroy said, “what it makes me want to do is scream out: ‘How dare you treat us like the carriers? We are your caregivers.’”

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A host of factors, from medical to cultural, have put large numbers of Filipinos in harm’s way and made them vulnerable to the types of severe complications that often turn deadly. They begin with the specific type of health care work they do.

A survey by the Philippine Nurses Association of America published in 2018 found that a large proportion of respondents were concentrated in bedside and critical care — “the opposite of social distancing,” said executive director Leo-Felix Jurado, who teaches nursing at William Paterson University in Wayne, New Jersey. Many of the organization’s members have contracted the virus, he said, including the current president, New Jersey-based registered nurse Madelyn Yu; she is recovering, but her husband died.

For Daisy Doronila, employed at the Hudson County Correctional Facility in northern New Jersey for more than two decades, the profession was almost a religious calling. “My mom had a very, very humble beginning,” said her only child, Denise Rendor. “She really wanted to take care of people that no one wanted to take care of.”

Doronila saw her responsibilities to her colleagues no less seriously. The single mother and devout Catholic “was always the most reliable person at the job,” Rendor said. “If there was a snowstorm, people called out, nope, not her: ‘I’ll be there.’” As a kid, Rendor sometimes resented the missed volleyball games and dance recitals. Looking back now, “I don’t think I would have the life that I had had my mom not worked so hard.”

It’s not clear how Doronila contracted the virus, though the Hudson County jail has had at least four deaths. Once she fell ill in mid-March, she was turned away for testing by clinics and doctors on three occasions because her symptoms didn’t meet the criteria at the time, Rendor said. On March 21, Doronila started feeling breathless and drove herself to urgent care, which sent her by ambulance to the hospital. She died on April 5 at the age of 60.

If she hadn’t gotten sick, Rendor is sure she would have been volunteering for extra shifts. “That’s just who my mother was. She was just always willing to help.”

That selflessness is common among Filipino immigrants, said Zenei Cortez, a registered nurse in the San Francisco Bay Area who is the president of the California Nurses Association/National Nurses United. “They have such a profound willingness to work that they would forget their own well-being,” she said. “They would think of their loved ones in the Philippines — if they don’t work, then they can’t send money back home.”

In 2019, Filipinos abroad sent $35 billion back to the Philippines, making it the fourth-largest recipient of overseas remittances in the world; many are also helping to support networks of relatives in the U.S. “That’s the economic factor that is on the minds of a lot of Filipino nurses,” Cortez said. “If we miss work, there will be no income.”

It’s a worry that keeps many Filipinos doing sometimes-grueling labor well into their 70s. Doronila’s colleague at the Hudson County jail, nurse Edwin Montanano, was 73 when he died in early April. Jesus Villaluz, a much-beloved patient transporter at Holy Name Medical Center in Teaneck, one of the worst-hit hospitals in northern New Jersey, was 75. “They cannot in their conscience walk away from patients who need them,” said Maria Castaneda, a registered nurse and the secretary-treasurer of 1199SEIU United Healthcare Workers East, who immigrated from the Philippines in 1984. “At the same time, they are there in solidarity with other co-workers. If they are not there, it adds to the burden of those who are working.”

COVID-19 risks are magnified in people who are older or suffer underlying chronic conditions. Filipinos have very high rates of Type II diabetes and cardiovascular disease, both of which render the virus more dangerous. “They’re doing amazing things and helping others to survive,” Nadal said. “But they’re putting themselves at risk because they have immuno-compromised traits that make them susceptible to severe sickness and death.”

And in many situations, they’ve been forced to do that work without proper PPE and other safeguards, said Ellorin, the Queens-based community organizer and executive director of the advocacy group Mission to End Modern-Day Slavery. They are “being infected and not being protected, and then their families, or whoever they live with, are getting infected.”

Sheryl Pabatao thinks of the many people she knows who are working in hospitals and other medical settings and feel unable to speak out. “Even though they don’t want to do things, they still do it because they don’t want to lose their jobs.”

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When they first applied to immigrate to the U.S. in the 1980s, Alfredo Pabatao was in the car business; Susana was a former nursing student turned housewife and mother of two. By the time their petition was approved about 14 years later, their two eldest children were too old to qualify to come to the U.S. with their parents, so the Pabataos were forced to leave them behind, bringing only their youngest two daughters and son. “To this day, that was one of the hardest things — being separated from everyone,” Sheryl said.

They arrived in the U.S. a few weeks after 9/11. One of Alfredo’s sisters, a registered nurse, helped him get a job transporting patients at her hospital, now known as Hackensack Meridian Health Palisades Medical Center, in North Bergen, New Jersey. “My father grew up with wealth, and when he came here, he had to be modest and humble,” Sheryl said. Susana earned her assistant nursing certification while working as a grocery store cashier, then went to work at what is now called Bergen New Bridge Medical Center in Paramus, the largest hospital and licensed nursing home in the state. Taking care of elderly people helped ease the sadness and guilt at what she had left behind. “She was not able to take care of her own mother,” Sheryl said. “So when she does her job here, she cares for them like her own.”

America proved to be both generous and hard. The couple prospered enough to buy a house, then lost it in the Great Recession. They managed to rebuild their lives and gained their U.S. citizenship, the kids choosing careers in the pharmaceutical side of health care. After 18 years in the same job, Alfredo was waiting for Susana to retire so he could, too.

Then came the pandemic.

Sheryl had been following the news reports from China since early February and was concerned enough about her family to procure a small supply of masks before vendors ran out; “I’d put my parents in a bubble if I can,” she said. Her father was more easygoing: “He has survived so many things in his life. His attitude is: ‘If I get it, I get it. I’ll be OK with it.’”

Sheryl doesn’t know how the responsibility fell to him to transport a patient suspected of having COVID-19 during the second week in March. “But knowing my dad, he agrees to anything. He has that work ethic: ‘This is my job. If I can do it, l do it.’ Knowing him, if one of the other [orderlies] didn’t want to transfer the patient, they asked him and he said yes.”

When Susana found out her husband had been exposed to the virus that way, she was not happy, Sheryl said. Susana was having her own issues at the nursing home. In mid-March, she received an email from her bosses that warned in boldface, “Facemasks are to be used only by staff who have an authorized or clinical reason to use them. Do not wear non-hospital issued facemasks.” It was a policy Susana complained was being made by people who weren’t doing bedside care and didn’t understand the real risks. She was also told the masks would scare patients. She pretended to obey the directive when her managers were around, Sheryl said, “but my mom was stubborn, so when they left, she put [her mask] back on.”

Bergen New Bridge called Susana a “valued” employee who is “greatly missed.” The hospital denied that it has experienced any PPE shortages, but it noted that “guidance from federal and state health officials regarding the use of PPE has been evolving.” Early on, “it was recommended that masks were to be worn only by those individuals who were sick or those who were caring for COVID-19 patients.” Once the virus began spreading within the community, “we quickly moved to universal masking of all employees,” the hospital said. “Like all healthcare facilities, our Medical Center has stressed the importance of using hospital-issued PPE, as guided by the CDC.”

As of April 29, New Bridge’s long-term care facility had recorded 120 confirmed COVID-19 cases and 26 deaths. Hackensack Meridian Health didn’t respond to ProPublica’s requests for comment about Alfredo’s case.

It wasn’t just Alfredo and Susana who fell ill. Sheryl and her brother, both living at home, caught the virus, too. The weekend before Alfredo’s symptoms emerged, he and the rest of the family attended a gathering in honor of a relative who had died in January from cancer. Alfredo spent much of the party talking to his younger brother; later, the brother ended up with COVID-19 and on a ventilator for nearly three weeks. An aunt of Sheryl’s who is a housekeeper in the same hospital system as Alfredo wasn’t at the gathering but fell ill anyway and was out sick for two weeks. Her symptoms weren’t as severe as those of some of the others; she’s already back at work.

The spread of the virus has been unrelenting for Sheryl. When she returned to her own job as a pharmacy tech this past week, a month after her parents died, she learned that someone who worked at her company — who was also Filipino — had died during her absence. “You have no idea about the extent of this,” she said, “until it hits you.”

Sophie Chou contributed reporting.

Correction, May 5, 2020: This story originally misspelled the first name of the president of the California Nurses Association/National Nurses United. She is Zenei Cortez, not Zeine.

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by Alice Wilder, WNYC

Presidential lawyer and former New York City Mayor Rudy Giuliani has largely fallen out of the public eye since his starring role in President Donald Trump’s impeachment. But Giuliani hasn’t gone silent.

Instead, he’s in his home, doing a call-in radio show and a podcast — “Common Sense” — during which he has repeatedly gone on bigoted rants about China and its government.

“They have no morals,” he said on his April 28 radio show. “They’re amoral in the sense that human life means something in Western civilization, it means a lot. Human life doesn’t mean the same thing to them.”

Giuliani has also speculated that the spread of the coronavirus may be a plot by the Chinese government.

For example, Giuliani has raised the possibility that China purposely released the virus from a biological lab in Wuhan. “We have to say accidentally,” Giuliani said in a recent radio broadcast. “But I don’t think as responsible investigators we can rule out that it wasn’t done deliberately.”

Experts say there’s no public evidence the virus came from the lab. Amid a reported White House push, U.S. intelligence agencies have said they are investigating the origins of the virus.

Giuliani is also fixated on the idea that the Chinese government sent sick people overseas. In an April 27 episode of his podcast, he said that China allowed “over a million people from Wuhan travel to us, to the United States, to England to France to Italy to Germany.” He added, “I hope the people there have the same reaction we have to the value of human life and the loss of human life.”

“When they found out about this terrible virus that escaped, assuming they didn’t do it on purpose,” Giuliani said a day later on his radio show, “they were going to make sure the West suffered as much if not more than they did and jumped on top of an opportunity, it’s not a big assumption to make. And there isn’t a contrary explanation.”

The New York Times found that thousands, not millions, of people flew internationally out of Wuhan.

Asked about his comments, Giuliani did not respond.

The comments by Giuliani have come as discrimination against Asian Americans has spiked. And they reinforce the White House’s emerging push to blame China for the pandemic.

Giuliani has said he’s spoken to the president a number of times about the coronavirus. Two days after Giuliani said he was sure the virus came from the Wuhan lab, Trump said he has evidence of the same. (The president declined to give the evidence, saying it’s secret.)

Giuliani appears to have found a receptive wider audience too. An advertising executive at 77 WABC, which airs Giuliani’s radio show, said “feedback has been amazing” and online listening has “skyrocketed.”

The station’s parent company, Red Apple Media, did not respond to a request for comment.

In an April 23 radio show, Giuliani interviewed Gordon Chang, a conservative pundit who frequently predicts the collapse of the Chinese government. Chang said if China released the virus accidentally — for which, again, there’s no evidence — it then decided to create a global pandemic. “I think what Xi Jinping did was he decided he was going to spread the virus so that he would level the playing field so that China would not be in such a hole,” Chang said, referring to China’s president.

“Wow,” Giuliani responded. “So he saw an opportunity, if that theory is correct, and it wasn’t a bioweapon to start with, he saw an opportunity that was sort of accidentally presented to him, and then he took advantage of it. It was opportunistic.”

Chang acknowledged, “We can’t know what was in Xi Jinping’s mind for sure.” But then he went on, “It looks more like they were deliberate and malicious and that means Mr. Mayor ... this is a crime against all of humanity.”

Giuliani ended the interview by inviting Chang to be a guest on his other show, the podcast.

Giuliani has also said he’d use his access to help guests on his show move ahead with exploratory treatments. Talking with one pharmaceutical executive on his show in late March, Giuliani told his guest, “I’ll use whatever my yelling and screaming can do to do it faster, to help you.”

As the Times reported, the executive’s company received initial trial approval from the Food and Drug Administration soon after. (The FDA has said the application was subject to “internal scientific review.” And Giuliani has said he has no business connection to the company.)

“I don’t lobby the government,” Giuliani emailed in response to a request for comment. “I do hope, however, that they and others are successful.”

Giuliani appears to have strong feelings about the government’s process for approving drugs.

In an April 23 broadcast, Mark, a pharmacist from New Jersey, called in to report on his “informal study” of the patients who have used a drug cocktail that includes hydroxychloroquine — the anti-malaria drug that Trump long has touted.

Giuliani was excited when Mark reported that none of his patients had been hospitalized: “Why doesn’t this count with all these geniuses in Washington? The double blind study and the triple blind study and this study and that study, we don’t have time for that, we’ve got to go to people like Mark in New Jersey!”

In fact, the FDA has warned against widespread use of the drug, noting that it can cause heart problems.

The discussions with his listeners, though, often come back to China.

One caller to Giuliani’s radio show, identifying himself as “George from Bay Ridge,” went on a rant against Chinese people, likening them to serial killers with “no conscience” who are attempting to take over businesses all over the world.

Giuliani responded, “George, I’ve been getting complaints about this for a long time.” He added: “It almost reminds me of the Mafia. You know, they say, if you do business with America it’s one thing. If you do business with China you don’t realize, all of a sudden you start owing them too much and they believe they own you.”

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