c 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
c The State Attorney General Is Scrutinizing This Assisted Living Facility Over Its Handling of COVID-19. Some Residents Are Suing It, Too. By tracking.feedpress.it Published On :: 2020-05-08T06:00:00-04:00 by Joaquin Sapien ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. This story is co-published with PBS Frontline. New York Attorney General Letitia James is looking into allegations that a Queens adult care facility has failed to protect residents from the deadly coronavirus and misled families about its spread, according to two lawmakers who asked for the inquiry and a relative of a resident who spoke to an investigator with the attorney general’s office. In a separate action Tuesday, three residents of the Queens Adult Care Center sued the facility in federal court over similar allegations. Both developments were prompted largely by ProPublica’s recent coverage of the facility, which houses both frail elderly residents and those with mental health issues. On April 2, we reported that workers and residents at the home were becoming ill with the coronavirus as residents wandered in and out of the home without any personal protective equipment. Family members later told ProPublica the management said no residents were sick with the virus at the time. On April 25, ProPublica published a story and a short film with the PBS series Frontline about the harrowing experience of Natasha Roland, who rescued her father in the middle of the night as he suffered coronavirus symptoms so severe he could barely breathe. Roland, in heart-wrenching detail, described how the management of the Queens Adult Care Center repeatedly assured her that her 82-year-old father, Willie Roland, was safe, even as the virus swept through the facility. She said workers were too scared to care for him, forcing his girlfriend, Annetta King-Simpson, to do so. King-Simpson later fell ill herself. Roland and King-Simpson are now suing the facility in federal court. Joe Singer and Katie Campbell/ProPublica In an interview, Assemblywoman Catalina Cruz, whose district covers Corona, Elmhurst and Jackson Heights, said she was troubled by what ProPublica reported. She said she hoped the attorney general can determine whether the Queens Adult Care Center had broken any laws. “It didn’t sit right with me. I thought something was off here. So I said let’s have the experts look at whether there was a crime or a civil violation,” she said. “Folks who live in this adult home deserve the same dignity as everyone else, and if their rights have been violated, someone needs to pay for that.” Cruz said she had been suspicious of the facility for several years and had come across a community Facebook page where people posted complaints about treatment of residents at the center. When she saw the ProPublica stories, she said she decided to take action, along with City Council member Daniel Dromm, who had already written to the New York State Department of Health and the office of Gov. Andrew Cuomo about the spread of the coronavirus in the facility on several occasions. “The plight of those living in adult care centers during this crisis was highlighted in a recent article published by ProPublica, which focused on the perils faced by the residents at the Queens Adult Day Care Center,” the lawmakers wrote in their April 27 letter to the attorney general and the governor’s office. “Failure to inform families about the health of loved ones, to lying and covering up deaths have become regular concerns we have received. We are aware that adult care centers are struggling to keep COVID-19 from affecting their residents and we also know that minorities have been disproportionately affected by the virus. It seems to us that management at this particular center have struggled to implement procedures and policies to protect the lives of its residents.” Cruz said she received an update from the attorney general’s office on May 5, saying it was looking into the matter but would not provide specific details. Days after the lawmakers sent the letter, Natasha Roland, 35, said she received a phone call from an investigator with the attorney general’s office. Roland said she recapped what she had previously told ProPublica: She began to worry about her father’s safety when nearby Elmhurst Hospital became a viral hot spot, but the management repeatedly told her there were no coronavirus cases in the facility. She said she only found out the truth weeks later when a worker she was friendly with advised her to come and pick up her father because the virus was raging through the facility and aides were becoming too scared to check on residents. In a subsequent interview, that worker denied telling Roland to pick up her dad. A spokesperson for the attorney general would not confirm or deny a specific, active investigation into the Queens Adult Care Center, but said James has received hundreds of complaints related to COVID-19 inside nursing homes and adult care facilities across the state and is investigating many of them. For its part, the Queens Adult Care Center has denied any wrongdoing and repeated its belief that Roland’s allegations are “baseless.” “Sadly, select elected officials and ProPublica have been intentionally misled with baseless assertions and utter fabrications crafted by the daughter of one of our long-term residents,” said Hank Sheinkopf, a crisis communications spokesperson hired by the facility. “We have strong reason to believe that this individual is seeking to use her father and other select residents as pawns in an attempt to extort the facility. We are considering our legal options.” He said the facility has “worked tirelessly” to protect its residents and is unaware of a “potential investigation,” but understood that “the AG’s office has contacted many nursing homes, adult care, and assisted living facilities seeking information. We are glad to be a resource to the AG’s office and have nothing to hide.” Bruce Schoengood’s 61-year-old brother, Bryan, lives in the facility and shared a room with one of the first residents to become infected with COVID-19 and subsequently die of the disease. Bruce told ProPublica he only learned that his brother’s roommate had died by happenstance during a casual conversation with his brother, and that he has complained for more than a month about a lack of communication from the facility. He said he had not yet heard from anyone with the attorney general’s office but would welcome such a conversation. In the meantime, Bryan Schoengood, Willie Roland and King-Simpson are suing the facility under the Americans with Disabilities Act. In a 59-page complaint, the group has asked a federal judge to appoint a special master to oversee the facility at the home’s expense to ensure that residents there are safe. The lawsuit argues that residents have experienced a “gross failure to provide the most basic level of care to safeguard their health and safety in the context of a global health pandemic. People with disabilities are exposed to high risks of contracting the virus with no or few preventative measures in place. Residents who fall sick are left to languish in their room without proper access to medical care.” The lawsuit claims that because the facility has failed to follow state and federal guidelines, “COVID-19 is rampant in the facility among residents and staff alike.” Alan Fuchsberg is the Manhattan-based personal injury and civil rights attorney representing the three Queens Adult Care Center residents. In an interview, he said that the facility may not have the resources to properly follow the guidelines, which is why a special master should be assigned to work with a team of outside experts to make sure it can. “Right now the residents are in a tinderbox,” he said. “And if you drop a match in there, all hell breaks loose. It should be run right. We don’t need dozens of people dying in all our nursing homes and adult care facilities. Some are running better than others and QACC sounds like a place that is not run up to standards.” He and Bruce Schoengood pointed out that they are not currently suing for damages, but rather to persuade a court to immediately intervene and offer support to the facility’s roughly 350 residents. Schoengood said the goals of the lawsuit are twofold. “I think it is both short term and long term,” he said. “Immediate intervention to put proper protocols in place to treat the sick and stop the spread of coronavirus and to communicate with family members. And in the long term I would like to see this facility much better prepared to handle another pandemic or a second wave.” Responding to the charges in the lawsuit, Sheinkopf again said that “the allegations are baseless and utter fabrications. Queens Adult Care Center (QACC) continues to meet all state issued guidelines.” Full Article
c Early Data Shows Black People Are Being Disproportionally Arrested for Social Distancing Violations By tracking.feedpress.it Published On :: 2020-05-08T18:22:00-04:00 by Joshua Kaplan and Benjamin Hardy ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. On April 17 in Toledo, Ohio, a 19-year-old black man was arrested for violating the state stay-at-home order. In court filings, police say he took a bus from Detroit to Toledo “without a valid reason.” Six young black men were arrested in Toledo last Saturday while hanging out on a front lawn; police allege they were “seen standing within 6 feet of each other.” In Cincinnati, a black man was charged with violating stay-at-home orders after he was shot in the ankle on April 7; according to a police affidavit, he was talking to a friend in the street when he was shot and was “clearly not engaged in essential activities.” Ohio’s health director, Dr. Amy Acton, issued the state’s stay-at-home order on March 22, prohibiting people from leaving their home except for essential activities and requiring them to maintain social distancing “at all times.” A violation of the order is a misdemeanor, punishable by up to 90 days in jail and a $750 fine. Since the order, hundreds of people have been charged with violations across Ohio. The state has also seen some of the most prominent protests against state stay-at-home orders, as large crowds gather on the statehouse steps to flout the directives. But the protesters, most of them white, have not faced arrest. Rather, in three large Ohio jurisdictions ProPublica examined, charges of violating the order appear to have fallen disproportionately on black people. ProPublica analyzed court records for the city of Toledo and for the counties that include Columbus and Cincinnati, three of the most populous jurisdictions in Ohio. In all of them, ProPublica found, black people were at least four times as likely to be charged with violating the stay-at-home order as white people. As states across the country attempt to curb the spread of COVID-19, stay-at-home orders have proven instrumental in the fight against the novel coronavirus; experts credit aggressive restrictions with flattening the curve in the nation’s hotbeds. Many states’ orders carry criminal penalties for violations of the stay-at-home mandates. But as the weather warms up and people spend more time outside, defense lawyers and criminal justice reform advocates fear that black communities long subjected to overly aggressive policing will face similarly aggressive enforcement of stay-at-home mandates. In Ohio, ProPublica found, the disparities are already pronounced. As of Thursday night in Hamilton County, which is 27% black and home to Cincinnati, there were 107 charges for violating the order; 61% of defendants are black. The majority of arrests came from towns surrounding Cincinnati, which is 43% black. Of the 29 people charged by the city’s Police Department, 79% were black, according to data provided to ProPublica by the Hamilton County Public Defender. In Toledo, where black people make up 27% of the population, 18 of the 23 people charged thus far were black. Lt. Kellie Lenhardt, a spokeswoman for the Toledo Police Department, said that in enforcing the stay-at-home order, the department’s goal is not to arrest people and that officers are primarily responding to calls from people complaining about violations of the order. She told ProPublica that if the police arrested someone, the officers believed they had probable cause, and that while biased policing would be “wrong,” it would also be wrong to arrest more white people simply “to balance the numbers.” In Franklin County, which is 23.5% black, 129 people were arrested between the beginning of the stay-at-home order and May 4; 57% of the people arrested were black. In Cleveland, which is 50% black and is the state’s second-largest city, the Municipal Court’s public records do not include race data. The court and the Cleveland Police Department were unable to readily provide demographic information about arrests to ProPublica, though on Friday, the police said they have issued eight charges so far. In the three jurisdictions, about half of those charged with violating the order were also charged with other offenses, such as drug possession and disorderly conduct. The rest were charged only with violating the order; among that group, the percentage of defendants who were black was even higher. Franklin Country is home to Columbus, where enforcement of the stay-at-home order has made national headlines for a very different reason. Columbus is the state capital and Ohio’s largest city with a population of almost 900,000. In recent weeks, groups of mostly white protesters have campaigned against the stay-at-home order on the Statehouse steps and outside the health director’s home. Some protesters have come armed, and images have circulated of crowds of demonstrators huddled close, chanting, many without masks. No protesters have been arrested for violating the stay-at-home order, a spokesperson for the Columbus mayor’s office told ProPublica. Thomas Hach, an organizer of a group called Free Ohio Now, said in an email that he was not aware of any arrests associated with protests in the entire state. The Columbus Division of Police did not respond to ProPublica’s request for comment. Ohio legislators are contemplating reducing the criminal penalties for violating the order. On Wednesday, the state House passed legislation that would eliminate the possibility of jail time for stay-at-home violators. A first offense would result in a warning, and further violations would result in a small fine. The bill is pending in the state Senate. Penalties for violating stay-at-home orders vary across the country. In many states, including California, Florida, Michigan and Washington, violations can land someone behind bars. In New York state, violations can only result in fines. In Baltimore, police told local media they had only charged two people with violations; police have reportedly relied on a recording played over the loudspeakers of squad cars: “Even if you aren’t showing symptoms, you could still have coronavirus and accidentally spread it to a relative or neighbor. Being home is being safe. We are all in this together.” Enforcement has often resulted in controversy. In New York City, a viral video showed police pull out a Taser and punch a black man after they approached a group of people who weren’t wearing masks. Police say the man who was punched took a “fighting stance” when ordered to disperse. In Orlando, police arrested a homeless man walking a bicycle because he was not obeying curfew. In Hawaii, charges against a man accused of stealing a car battery, normally a misdemeanor punishable by up to 30 days in jail, were enhanced to a felony, which can result in 10 years in prison, because police and prosecutors said he was in violation of the state order. The orders are generally broad, and decisions about which violations to treat as acceptable and which ones to penalize have largely been left to local police departments’ discretion. Kristen Clarke, president of the Lawyers’ Committee for Civil Rights Under Law, a legal organization focused on racial justice, said such discretion has opened the door to police abuse, and she said the U.S. Department of Justice or state governments should issue detailed guidelines about when to make arrests. That discretion “is what’s given rise to these rogue practices,” she told ProPublica, “that are putting black communities and communities of color with a target on their backs.” In jails and prisons around the country, inmates have fallen ill or died from COVID-19 as the virus spreads rapidly through the facilities. Many local governments have released some inmates from jail and ordered police to reduce arrests for minor crimes. But in Hamilton County, some people charged with failing to maintain social distancing have been kept in jail for at least one night, even without any other charges. Recently, two sheriff’s deputies who work in the jail tested positive for COVID-19. “The cops put their hands on them, they cram them in the car, they take them to the [jail], which has 800 to 1400 people, depending on the night,” said Sean Vicente, director of the Hamilton County Public Defender’s misdemeanor division. “It’s often so crowded everyone’s just sitting on the floor.” Clarke said the enforcement push is sometimes undercutting the public health effort: “Protecting people’s health is in direct conflict with putting people in overcrowded jails and prisons that have been hotbeds for the virus.” Court records show that the Cincinnati Police Department has adopted some surprising applications of the law. Six people were charged with violations of the order after they were shot. Only one was charged with another crime as well, but police affidavits state that when they were shot, they were or likely were in violation of the order. One man was shot in the ankle while talking to a friend, according to court filings, and “was clearly not engaged in essential activities.” Another was arrested with the same explanation; police wrote that he had gone to the hospital with a gunshot wound. The Cincinnati Police Department did not respond to ProPublica’s requests for comment. In Springfield Township, a small, mostly white Cincinnati suburb, nine people have been arrested for violating the order thus far. All of them are black. Springfield Township Police Chief Robert Browder told ProPublica in an email that the department is “an internationally accredited law enforcement organization” and has “strict policies ... to ensure that our zero tolerance policy prohibiting bias-based profiling is adhered to.” Browder said race had not played a role in his department’s enforcement of the order and that he was “appalled if that is the insinuation.” Several of the black people arrested in Springfield Township were working for a company that sells books and magazine subscriptions door to door. One of the workers, Carl Brown, 50, said he and five colleagues were working in Springfield Township when two members of the team were arrested while going door to door. Police called the other sales people, and when they arrived at the scene, they too were arrested. Five of them, including Brown, were charged only with violating the stay-at-home order; the sixth sales person had an arrest warrant in another state, according to Browder, and police also charged her for giving them false identification. Brown said one of the officers had left the group with a warning: They should never come back, and if they do, it’s “going to be worse.” Browder denied that the officers made such a threat, and he said the police had received calls from residents about the sales people and their tactics and that the sales people had failed to register with the Police Department, as required for door-to-door solicitation. Other violations in Hamilton County have been more egregious, but even in some of those cases, the law enforcement response has stirred controversy. On April 4, a man who had streamed a party on Facebook Live, saying, “We don’t give a fuck about this coronavirus,” was arrested in Cincinnati’s Over-the-Rhine neighborhood, the setting of a 2001 riot after police fatally shot an unarmed black man. The man who streamed the party, Rashaan Davis, was charged with violating the stay-at-home order and inciting violence, and his bond was set at $350,000. After Judge Alan Triggs said he would release Davis from jail pretrial because the offense charged was nonviolent, local media reported, prosecutors dropped the misdemeanor and said they would focus on the charge of inciting violence, a felony. The Hamilton County prosecutor’s office declined to comment on Davis’ case. In Toledo, there’s been public controversy around perceived differences in the application of the law. On April 21, debate at the Toledo City Council meeting centered around a food truck. Local politicians discussed recent arrests of young black people at house parties, some contrasting them with a large, white crowd standing close together in line outside a BBQ stand, undisturbed by police. Councilmember Gary Johnson told ProPublica he’s asked the police chief to investigate why no one was arrested at a party he’d heard about, where white people were congregating on docks. “I don’t know the circumstances of the arrests,” he said. But “if you feel you need to go into poor neighborhoods and African American neighborhoods, you better be going into white neighborhoods too. … You have to say we’re going to be heavy-handed with the stay-at-home order or we’re going to be light with it. It has to be one or the other.” Toledo police enforcement has not been confined to partygoers. Armani Thomas, 20, is one of the six young men arrested for not social distancing on a lawn. He told ProPublica he was sitting there with nine friends “doing nothing” when the police pulled up. Two kids ran off, and the police made the rest stay, eventually arresting “all the dudes” and letting the girls go. He was taken to the county jail, where several inmates have tested positive, for booking and released after several hours. The men’s cases are pending. “When police see black people gathered in public, I think there’s this looming belief that they must be doing something illegal,” RaShya Ghee, a criminal defense attorney and lecturer at the University of Toledo, told ProPublica. “They’re hanging out in a yard — something illegal must have happened. Or, something illegal is about to happen.” Lenhardt, the police lieutenant, said the six men were arrested after police received 911 calls reporting “a group gathering and flashing guns.” None of the six men were arrested on gun charges. As for the 19-year-old charged for taking the bus without reason, she said police asked him on consecutive days to not loiter at a bus station. With more than 70,000 Americans dead from the coronavirus, government officials have not figured out how to balance the threat of COVID-19 with the harms of over policing, Clarke said. “On the one hand, we want to beat back the pandemic. That’s critical. That’s the end goal,” she told ProPublica. “On the other hand, we’re seeing social distancing being used as a pretext to arrest the very communities that have been hit hardest by the virus.” Full Article
c I’m an Investigative Journalist. These Are the Questions I Asked About the Viral “Plandemic” Video. By tracking.feedpress.it Published On :: 2020-05-09T07:00:00-04:00 by Marshall Allen ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The links to the viral video “Plandemic” started showing up in my Facebook feed Wednesday. “Very interesting,” one of my friends wrote about it. I saw several subsequent posts about it, and then my brother texted me, “Got a sec?” My brother is a pastor in Colorado and had someone he respects urge him to watch “Plandemic,” a 26-minute video that promises to reveal the “hidden agenda” behind the COVID-19 pandemic. I called him and he shared his concern: People seem to be taking the conspiracy theories presented in “Plandemic” seriously. He wondered if I could write something up that he could pass along to them, to help people distinguish between sound reporting and conspiracy thinking or propaganda. So I watched “Plandemic.” I did not find it credible, as I will explain below. YouTube, Facebook and Vimeo have since removed it from their platforms for violating their guidelines. Now it’s available on its own site. Sensational videos, memes, rants and more about COVID-19 are likely to keep coming. With society polarized and deep distrust of the media, the government and other institutions, such content is a way for bad actors to sow discord, mostly via social media. We saw it with Russia in the 2016 election and we should expect it to continue. But what surprised me is how easily “Plandemic” sank its hooks into some of my friends. My brother also felt alarmed that his own church members and leaders in other churches might be tempted to buy into it. The purpose of this column is not to skewer “Plandemic.” My goal is to offer some criteria for sifting through all the content we see every day, so we can tell the difference between fair reporting and something so biased it should not be taken seriously. Here’s a checklist, some of which I shared with my friends on Facebook, to help interrogate any content — and that includes what we publish at ProPublica. Is the Presentation One-Sided? There’s never just one side to a story. I mentioned this point in 2018 when I wrote about my faith and the biblical basis for investigative reporting. One of my favorite Proverbs says, “The first to state his case seems right until another comes and cross-examines him.” So a fair presentation should at least acknowledge opposing points of view. I didn’t see this in “Plandemic,” so I called the filmmaker, Mikki Willis, who is also the film’s narrator, to ask him whether I had somehow missed the other side of the argument. I had not. “The other side of the argument plays 24/7 on every screen in every airport and on every phone and in every home,” Willis said. “The people are only seeing one side of the story all the time. This is the other side of the story. This is not a piece that’s intended to be perfectly balanced.” I asked Willis if it was fair to call his film “propaganda,” which the Oxford dictionary defines as “information, especially of a biased or misleading nature, used to promote or publicize a particular political cause or point of view.” He said he doesn’t feel there’s anything misleading in his film, but otherwise the definition fits. And based on that definition he feels 100% of news reporting is propaganda. “What isn’t propaganda these days?” he asked. “In that sense, what we’re doing is fighting fire with fire.” Is There an Independent Pursuit of the Truth? The star of “Plandemic,” medical researcher Judy Mikovits, is controversial. The magazine Science reports that it published and then retracted one of her papers in 2011. A search warrant provided to ProPublica by one of her former attorneys shows she was fired from her position at Whittemore Peterson Institute, a research center in Nevada, in September 2011. Then she allegedly stole notebooks and a laptop computer from the Institute, the search warrant said, leading to an arrest warrant for alleged possession of stolen property and unlawful taking of computer data. She was arrested on Nov. 18, 2011, but denied wrongdoing. The charges were dropped. But “Plandemic” ignores or brushes past these facts and portrays her as an embattled whistleblower. “So you made a discovery that conflicted with the agreed-upon narrative?” Willis says to Mikovits, introducing her as a victim. “And for that, they did everything in their powers to destroy your life.” A typical viewer is not going to know the details about Mikovits’ background. But as the primary source of controversial information being presented as fact, it’s worth an online search. The fact-checking site PolitiFact details her arrest and criminal charges. Clearly, there’s more to her story than what’s presented in “Plandemic.” That should give us pause when we assess its credibility. Is There a Careful Adherence to the Facts? In “Plandemic,” Willis asks Mikovits about her arrest: “What did they charge you with?” “Nothing,” she replies. “I was held in jail, with no charges.” Being charged with a crime is one of those concrete facts that we can check out. Science magazine reported Mikovits’ arrest and felony charge. I also found a civil lawsuit she filed against the Whittemore Peterson Institute in 2014 in the U.S. District Court for the Southern District of California. “Mikovits was arrested on criminal charges…” her complaint says in the case, which was eventually dismissed. I asked Willis about the apparent discrepancy, where she said in his film that she wasn’t charged, when court documents show that she was charged. After my inquiry, he said he spoke to Mikovits and now feels it is clear that she meant that the charges were dropped. I tracked down Mikovits and she said what she meant in the film is that there were no charges of any type of wrongdoing that would have led to her being charged with being a fugitive from justice. She admitted that all the controversy has been hard for her to sort out. “I’ve been confused for a decade,” she told me. She said she would try to be more clear in the future when she talks about the criminal charge: “I’ll try to learn to say it differently,” she said. This underscores the importance of careful verification, and it distinguishes the craft of journalism from other forms of information sharing. People often speak imprecisely when they’re telling their stories. It’s our duty to nail down precisely what they do and do not mean, and verify it independently. If we don’t, we risk undermining their credibility and ours. That’s in part why we at ProPublica and many other journalists often link directly to our underlying source documents, so you can verify the information yourself. Are Those Accused Allowed to Respond? Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is one of the nation’s leaders in the response to the coronavirus. In “Plandemic,” Mikovits accuses Fauci of a cover-up and of paying off people who perpetrate fraud, among other things. PolitiFact found no evidence to support the allegations against Fauci. Every time I write a story that accuses someone of wrongdoing I call them and urge them to explain the situation from their perspective. This is standard in mainstream journalism. Sometimes I’ve gone to extreme lengths to get comments from someone who will be portrayed unfavorably in my story — traveling to another state and showing up at their office and their home and leaving a note if they are not there to meet me. “Plandemic” doesn’t indicate whether the filmmakers reached out to Fauci for his version of the story. So I asked Willis about it. “We did not,” he told me. Are All Sources Named and Cited, and if Not, Is the Reason Explained? All sources should be identified, with their credentials, so viewers can verify their expertise or possible biases. If they can’t be for some reason, then that should be explained. “Plandemic” features unnamed people in medical scrubs, presented as doctors, saying they’re being wrongly pressured to add COVID-19 on people’s death certificates or are not being allowed to use the drug hydroxychloroquine to treat patients. But the speakers are not named, so we can’t really tell who they are, or even if they are doctors at all. That makes it impossible to tell if they are credible. I asked Willis why he didn’t name those people. He told me he was in a hurry to release the 26-minute version of “Plandemic,” but the doctors will be named in the final version. “We should have done that,” he said. Does the Work Claim Some Secret Knowledge? “Plandemic” calls itself a documentary that reveals “the hidden agenda behind COVID-19.” We are in the midst of a global pandemic where few people in the world can figure out what is happening or the right way to respond, let alone agendas. We have almost every journalist in the country writing about this. And if the truth about a conspiracy is out there, many people have an incentive to share it. But “Plandemic” would like us to think it’s presenting some exclusive bit of secret knowledge that is going to get at the real story. That’s not likely. Plus, to be honest, there were so many conspiratorial details stacked on top of each other in the film I couldn’t keep them straight. When I spoke to Willis I told him I was having a hard time understanding his point. Then I took a stab at what I thought was the main thrust of his argument. “Are you saying that powerful people planned the pandemic and made it happen so they could get rich by making everyone get vaccines?” I asked. It turns out Willis isn’t sure either. “We’re in the exploratory phase,” he told me. “I don’t know, to be clear, if it’s an intentional or naturally occurring situation. I have no idea.” Then he went on to say that the pandemic is being politicized and used to take away our civil liberties and leverage other political policies. “Certain forces” have latched onto the situation, he said. “It’s too fishy.” He had me at, “I have no idea.” That sums it up. This is a vast pandemic and massive catastrophe. Our country wasn’t prepared for it, and the response by our top leaders has been disjointed. We’re restricted to our homes. Many people have lost their jobs and some are afraid or sick or dying. That makes us vulnerable to exploitation by people who will present inaccurate or intellectually dishonest information that promises to tell us the truth. Perhaps “Plandemic” is guilty of sloppy storytelling, or maybe people really do believe the things they’re saying in the video. Or perhaps they’re being intentionally dishonest, or it’s a biased connecting of the dots rooted in personal and professional grievances. I don’t know because I can’t get inside their heads to judge their motives. Ultimately, we’re all going to need to be more savvy consumers when it comes to information, no matter how slickly it’s presented. This may be but a signal of what’s to come in the run-up to the 2020 presidential election, when memes and ads of unknown origin come across our social media feeds. There are standards for judging the credibility of the media we take in every day, so let’s apply them. Full Article
c COVID-19 Took Black Lives First. It Didn’t Have To. By tracking.feedpress.it Published On :: 2020-05-09T08:00:00-04:00 by Duaa Eldeib, Adriana Gallardo, Akilah Johnson, Annie Waldman, Nina Martin, Talia Buford and Tony Briscoe ProPublica Illinois is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. Larry Arnold lived less than a mile from a hospital but, stepping out of his South Side apartment with a 103-degree fever, he told the Uber driver to take him to another 30 minutes away. Charles Miles’ breathing was so labored when a friend called to check on him that the friend called an ambulance. Still, Miles, a retired respiratory therapist, was reluctant to leave his home. Close family support had helped Rosa Lynn Franklin recover from a stroke several years ago, but when she was admitted to the hospital in late March, her daughter could do little more than pat her on the back and say goodbye. All three were among the first people to die of COVID-19 in Chicago, and all three were African American. Their deaths reflect the stunning racial disparity in the initial toll of the virus. Of the city’s first 100 recorded victims, 70 were black. As the pandemic has spread, that gap has narrowed, and Latinos now make up the largest portion of any reported demographic of confirmed cases across Illinois, state data shows. But the disparity in black deaths persists. As of early May, African Americans, who make up just 30% of Chicago’s population, are about half of its more than 1,000 coronavirus deaths. It has been well established that African Americans are dying of COVID-19 at a disproportionate rate in cities across America. ProPublica sought to explore the problem by examining the first 100 recorded deaths in Chicago, a city with a rich and often troubled history on issues of race. Using a database obtained from the Cook County Medical Examiner’s Office that listed the names, health and location information of all COVID-19-related deaths, reporters reached out to the families and friends of each person who died. Reporters ultimately spoke with those who knew 22 of the victims; gleaned details about the lives of many others from obituaries and social media posts; and interviewed experts, medical professionals and government officials to understand how and why those first 100 died. The racial disparities in coronavirus deaths have largely been attributed to endemic and entrenched inequalities in Chicago — decades of disinvestment in the predominantly black neighborhoods on the South and West sides that have left residents with fewer jobs, poorer health and diminished opportunities. Those forces often are portrayed as intractable and, during a pandemic, nearly impossible to fix. Chicago Mayor Lori Lightfoot acknowledged the challenge when she spoke publicly about the disparities last month and announced a plan to address them. “We’re not going to reverse this in a moment, overnight, but we have to say it for what it is and move forward decisively as a city, and that’s what we will do,” she said. “This is about health care accessibility, life expectancy, joblessness and hunger.” While all this is true, ProPublica’s reporting also revealed other patterns, factors that could — and should — have been addressed and which almost certainly exist in other communities experiencing similar disparities. Even though many of these victims had medical conditions that made them particularly susceptible to the virus, they didn’t always get clear or appropriate guidance about seeking treatment. They lived near hospitals that they didn’t trust and that weren’t adequately prepared to treat COVID-19 cases. And perhaps most poignantly, the social connections that gave their lives richness and meaning — and that played a vital role in helping them to navigate this segregated city that can at times feel hostile to black residents — made them more likely to be exposed to the virus before its deadly power became apparent. Many of the first 100 recorded Chicago COVID-19 victims led lives threaded through with community and civic involvement, powerfully connected to their city, to friends and family. Some had led careers of service, like Patricia Frieson, a retired nurse, and Rhoda Hatch, a former teacher, and Carl Redd, a U.S. Army veteran. Their small businesses helped shape their corners of the city; Hardwell Smith, 85, arrived in Chicago as part of the Great Migration from the Jim Crow South and established gas stations and auto repair shops on the South Side. They were church deacons and musicians; doting uncles like 32-year-old Carl White and nurturing mothers like Juliet Davis, who, despite her limited means, fed the homeless who lived under a neighborhood viaduct. Most of the first 100 lived in majority-black neighborhoods, according to an analysis of medical examiner data; hardest hit were South Shore, Auburn Gresham and Austin, where the median income for 40% or more of the residents in each community is less than $25,000. Many were already sick, with underlying health conditions. Seventy-eight of them had hypertension and 53 had diabetes. Just 12 had one health condition, and only five people had no comorbidities. James Brooks, a 27-year-old black man, was the youngest to die. “I’m not surprised because every natural disaster will peel back the day-to-day covers over society and reveal the social fault lines that decide in some ways who gets to live and who gets to die,” said Dr. David Ansell, senior vice president for community health equity at Rush University Medical Center. “And in the United States, those vulnerabilities are often at the intersection of race and health.” Ansell, who wrote “The Death Gap: How Inequality Kills,” has spent decades documenting the life expectancy gap between black and white Chicagoans, which is the largest in the country. Structural racism, concentrated poverty, economic exploitation and chronic stress cause what’s known as biological weathering, Ansell said, where the body ages prematurely and results in earlier death. Who dies first is different for each pandemic, said Dr. Howard Markel, director of the Center for the History of Medicine at the University of Michigan. The coronavirus’s earliest victims, he said, were the most vulnerable. “They’re not quite forgotten, but we don’t pay close enough attention to the health and well-being of this segment of the population,” he said. “Then a microscopic organism comes and topples them over.” They were vulnerable, but their deaths cannot be dismissed as inevitable. One-Size-Fits-All Guidance Phillip Thomas, 48, started to feel sick while working a day shift at the Walmart in Evergreen Park. A diabetic, he was cautious about his health, and he reached out to a doctor, who told him to stay home and self-quarantine in case he had the coronavirus. About a week into his bedrest, Thomas told his sister Angela McMiller that he was having a hard time standing up and was vomiting, no longer able to keep anything down. She encouraged him to go to the emergency room, but he didn’t immediately go, citing the doctor’s advice to stay home. Within a couple of days, he called an ambulance, which took him to Jackson Park Hospital, where he was intubated. Two days later, on March 29, he died, in the hospital where he was born. When McMiller next saw her brother, it was at his funeral, which only 10 people could attend because of social distancing requirements. “It was devastating,” said McMiller. “My mother fell down, my brothers cried.” McMiller is upset that her brother was told to stay home when he was sick, particularly considering the additional risks posed by his health history. “It shocked me,” she said. “He was diabetic.” Since the earliest days of the pandemic, the Centers for Disease Control and Prevention’s guidelines have emphasized staying home when symptoms are mild. “Most people with COVID-19 have mild illness and can recover at home without medical care,” the CDC says on its website. It recommends people call a doctor before going to get care in person, unless experiencing emergency signs like trouble breathing, blue lips or chest pain. But experts told ProPublica that this one-size-fits-all advice does not account for the fact that African Americans are not only more likely to have preexisting conditions that increase their chances of bad outcomes, but also have a long-standing wariness of the health care system. “There is this distrust between black communities and health care systems based on this fraught history of how health care systems have exploited and abused black people,” said Dr. Uché Blackstock, an emergency medicine physician in Brooklyn and the founder and CEO of Advancing Health Equity. “What happens as a result of that is that patients don’t want to interface with the health care system.” In addition, doctors said patients may delay seeking care out of a fear of the medical bills, lack of insurance or transportation barriers — all of which underscores the need for targeted guidance. So instead of encouraging staying at home, these doctors want guidance to encourage African American patients to proactively seek care before symptoms get out of hand. Dr. Mira Iliescu-Levine, a pulmonary critical care doctor at The Loretto Hospital on Chicago’s West Side, is concerned that African American and Latino patients are waiting to come to the hospital after their symptoms become too severe. “You end up with an overwhelming clinical picture, almost like a tornado, that’s very hard to stop,” she said. She said she wants patients, especially her African American patients with diabetes, obesity and other comorbidities, to seek care when they have “innocent symptoms” like a cough, runny nose, itchy eyes or low-grade fever. Earlier treatment does not guarantee a better outcome, she said, but it can give the patient a fighting chance. “Reach out,” she said. “Don’t wait.” Asked whether the CDC would consider tailoring its recommendations to reflect the underlying health conditions and barriers to care in African American communities, a spokesperson said the “CDC is collecting data to monitor and track disparities among racial and ethnic groups … to help inform decisions on how to effectively address observed disparities. … We will continue to update our recommendations as we learn more.” The CDC spokesperson said the agency has increased “engagement with organizations and other partners representing and serving racial and ethnic minority groups to identify gaps in the current response efforts,” and that people should “never avoid emergency rooms or wait to see a doctor if you feel your symptoms are serious.” On the first day, Willie Flake, a 72-year-old mechanic, lost his ability to taste. Then, he lost his appetite. With each new coronavirus symptom he experienced, his sister Betty and her daughter Yolanda pushed him to go to the hospital. But Flake, who had diabetes, stayed home because he thought his symptoms were not severe enough to go to the emergency room. He soon developed a fever. By the fourth day, he had trouble breathing. Flake took an ambulance to Rush University Medical Center on March 27, where his condition appeared to stabilize before worsening again. “They say, ‘Don’t come in until your fever is high and you can’t breathe,’” Yolanda Flake said. “That’s the part where I feel like they failed him. He waited until he couldn’t breathe and it was too late.” In the early hours of April 1, his sister and niece put on masks and gloves and looked through the glass window of his hospital room. He had been like a father to Yolanda, attended every graduation, from kindergarten through college, and had recently accompanied her to buy a car for her daughter, his 23-year-old grandniece, LaSeanda. Yolanda said she wished she could have been with him inside the room, regardless of the risks. “I wanted to touch him,” she said. “I wanted to talk to him before he took his last breath. I couldn’t say it through the glass door.” And then, his heart stopped. “He waited at home,” Yolanda said, “and he was dying already.” Struggling Hospitals Larry Arnold also waited, not because he was instructed to, but because he didn’t trust his neighborhood hospitals. Two — Jackson Park Hospital and South Shore Hospital — sit within five minutes of his home. Both are century-old nonprofit facilities that serve majority low-income and uninsured patients on the South Side. When Arnold started to feel sick in mid-March, he worried that if he called an ambulance, it would take him to one or the other. He didn’t want to go to either. “What upsets me is that we don’t have adequate medical facilities where we can go to and feel like we’ll be cared for,” his niece Angelyn Vanderbilt said. “I’m sure they’re very good people … but the consensus in the community is that those hospitals are inadequate and they have been for years.” After his fever didn’t subside for a few days, Arnold, who was 70 and had chronic obstructive pulmonary disease, or COPD, knew he couldn’t wait any longer, his family said. He got into an Uber with a temperature of 103 and told the driver to take him to Advocate Christ Medical Center in Oak Lawn, some 30 minutes away. On March 31, 16 days after he was admitted, the nurse put the phone to Arnold’s ear one last time. “We told him to be strong and to continue to fight,” Vanderbilt said. He died about an hour later. People who live on Chicago’s South and West sides are often at a geographic disadvantage during medical crises because the hospitals that are closest to them frequently are those with fewer resources. Illinois Gov. J.B. Pritzker acknowledged the hardships at a press briefing last month. “The safety-net hospitals are challenged in our state, and the availability of health care in communities of color has been at a lower quality or lower availability than in other communities,” he said. The city’s safety-net hospitals, facilities that serve a large portion of low-income and uninsured patients regardless of their ability to pay, don’t have the private-insurance patient base or the cash reserves to fall back on during a pandemic that many larger hospitals have, said Larry Singer, associate professor at the Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law. Some are millions of dollars in the red and housed in aging buildings. And while their mission is a valiant one, he said, they have not been able to respond to the coronavirus as quickly or with the same equipment and staffing. “They’re trying to fight the same fight as everybody else with one arm tied behind their back,” Singer said. “They deserve the resources to do an even better job. I’m truly impressed by what they are trying to achieve during a time of crisis.” Tim Caveney, president and CEO of South Shore Hospital, said that limited resources is one reason safety-net hospitals have struggled to earn the trust of the communities they serve. “Safety net [hospitals] have gotten a bad beat because we don’t have much money. It’s a funding issue,” he said, adding that the pandemic has aggravated South Shore’s financial issues. Not only have lucrative elective surgeries been postponed, but COVID-19 patients often require complex and lengthy care, which can be expensive. Dr. Khalilah Gates, an African American pulmonary and critical care specialist at Northwestern Memorial Hospital who has family on the South Side, said she is painfully aware that some black patients may prefer to “wait it out” or travel to distant hospitals. “Both of those are very common phenomenons,” she said. “Not all community hospitals, but many of the community hospitals in those communities lack the resources that offer security to the residents in those areas.” ProPublica spoke with several families who said their loved ones either delayed care because they didn’t want to go to neighborhood hospitals or ultimately wound up in those hospitals as a last resort. Miles, the retired respiratory therapist, had worked for about 40 years at Northwestern Memorial Hospital providing breathing treatments for patients there. When he started feeling sick in mid-March, he knew what resources he might need. A friend called him on March 22 and heard his labored breathing. He told Miles that he was calling an ambulance, but Miles resisted, in part, because he didn’t want to be taken to Jackson Park, the nearest hospital. “He should’ve been in there a week before that,” said his sister Roselle Jones. “But he was insistent on not going.” The paramedics said that they had to take him to Jackson Park because it was the closest hospital. Miles’ family asked that he be transferred to another hospital, but once he tested positive for the coronavirus, a doctor told the family that Miles couldn’t be moved, Jones said. By the end of the week, Miles had been sedated and placed on a ventilator. He died on April 3. “We wanted him out of there. We wanted him somewhere he could get some good care,” Jones said. “The doors should be closed, and the building torn down.” Philman Williams’ family also said they tried in vain to get him transferred out of Jackson Park after an ambulance took him there. Williams, 70, worked as a doorman at a luxury high-rise where residents dubbed him the “Mayor of Michigan Avenue” for his charm and good humor. Not only was his doctor at another hospital, but the family worried about the quality of care he would receive. A day after he was admitted, their concerns were amplified by a news story detailing reports from employees that the hospital did not have enough personal protective equipment, prompting nurses to avoid entering patient rooms. Nurses who were sick and those afraid to come to work because they had elderly relatives at home have led to staffing shortages, said Kindra Perkins, a representative with National Nurses United, the union that represents nurses at Jackson Park. One day, an ambulance couldn’t drop off a patient because there were only two nurses working in the emergency room, she said. “The nurses deserve to have the resources that they need to provide the quality care in that community, and the people in that community are just as important as the folks on the North Side of Chicago,” Perkins said. Margo Brooks-Pugh, a vice president of development at Jackson Park Hospital, did not answer specific questions, but she wrote in an email that the hospital takes patient and staff safety seriously. “Jackson Park Hospital follows all guidelines and standards as related to patient care and safety,” she wrote. Austin, on the West Side, is one of the city’s largest and most chronically underserved areas. It has become a hot spot for COVID-19 cases. The Loretto Hospital, a small nonprofit that has been an anchor in the community for more than 90 years, is the primary provider in the area. Like many of the safety-net hospitals in Chicago, it has struggled financially for years. When Asberry Stoudemire Jr., a 54-year-old diabetic, got a runny nose, then felt his blood sugar levels begin to fall, his family knew he needed to get care quickly. He also had a history of congestive heart failure, which had forced the avid stepper and musician to retire early from his job as a certified nursing assistant. The Loretto Hospital wasn’t their first choice — or their second. But it was the closest. Within hours of arriving at Loretto, his condition deteriorated so rapidly that he was sedated and intubated. His daughter Miranda Stoudemire said she had trouble getting a clear sense of what was going on in the 10 days her father spent in the hospital’s recently reopened 15-bed ICU. Loretto couldn’t afford to keep the unit up and running before the pandemic, a fate hospital administrators said they fear could be repeated without an infusion of cash as the pandemic continues. “He was saying, ‘I know one thing, I’m not going to Loretto,’” she said. But he did, and she is resolute in her belief that her father would have lived longer had he been at a better resourced hospital. His family tried having him transferred but said they were told he was too critical to be moved. “I feel like he didn’t even have a chance to fight,” she said. He died March 29. Mark A. Walker, spokesman for The Loretto Hospital, said that the hospital has the capacity to care for its patients and is doing its best to communicate with families. “This hospital has gone through hard times,” he said. “We’re doing everything we can. We’re learning along with everybody else. But better resourced communities don’t have to fight for the same divvy of health care resources that we do.” Although L.B. Perry was 78 and suffered from hypertension and diabetes, nothing usually kept him in bed. So when he didn’t wake at 6:30 for his morning oatmeal and coffee, his family began to worry. As he grew weaker and needed help walking to the bathroom, his family urged him to go to the hospital. After a few days, he relented and went to Holy Cross Hospital in Chicago Lawn on the South Side, but he was sent home, his daughter Vernice Perry said. “That’s why I’m so upset,” she said. “He was in the age bracket, and he has all these health conditions, and he had some of the symptoms.” His condition worsened at home, and his daughter said she begged him to let her drive him to another hospital. Four days later, his wife called an ambulance in the early morning of March 30, and he returned to Holy Cross Hospital. He died on April 2. Dan Regan, a spokesperson for Sinai Health System, did not answer questions about specific patients, citing privacy restrictions. He said that its hospitals, including Holy Cross, are “thoroughly prepared for handling the COVID-19 pandemic,” having created dedicated COVID-19 teams, using mobile triage trailers outside facilities to handle sick patients, and isolating COVID-19 patients in specialized rooms. “It is worth noting though that the challenging nature of COVID-19 is that patients can look fine at one point and be discharged home with monitoring and follow-up, only to deteriorate and have to return to the hospital,” said Regan. “This has been seen in many cases nationwide.” At least 110 patients from community hospitals, including Holy Cross, have been transferred to Rush University Medical Center, a large, well-equipped facility that has been touted as having been “built for a pandemic.” “They’re really patients that otherwise, in all likelihood, would not survive at those hospitals,” said Dr. Paul Casey, Rush’s acting chief medical officer. “The resources just aren’t the same. Nor is the ability within critical care to provide a lot of the life-saving therapies.” The City’s Response On April 6, when Mayor Lightfoot publicly announced that the coronavirus was disproportionately affecting the city’s black residents, the virus had been in Chicago at least since January, and more than 100 people were dead. The majority were black. “When we talk about equity and inclusion, they’re not just nice notions,” Lightfoot said at the time. “They are an imperative that we must embrace as a city. And we see this even more urgently when we look at these numbers and this disparity. It’s unacceptable. No one should think that this is OK.” That day, the city announced the Racial Equity Rapid Response Team in partnership with West Side United, with a goal to “bring a hyper local public health strategy to targeted communities.” In the weeks since, the team has held tele-town halls, delivered thousands of door hangers and postcards with targeted information, and distributed 60,000 masks for residents in the predominantly black communities of Austin, Auburn Gresham and South Shore. Dr. Allison Arwady, the city’s public health commissioner said in an interview that officials had worked behind the scenes to combat rumors that black people couldn’t contract the coronavirus, reaching out to community and faith leaders on the South and West sides in February and March to let them know the city was seeing cases across all races. Arwady said the department at first hoped to contain the spread. It had tracked the cases for weeks as the virus crept through the city, and then exploded. By the end of March, more than 40 Chicagoans had died from the virus, according to the county medical examiner data, though the city said its tally of deaths was less than half of that. For the most part, Lightfoot has received plaudits for her handling of the pandemic. Illinois was one of the first states in the country to release statistics on COVID-19 deaths by race. Lightfoot herself has even become something of a national political star, with viral videos and memes of her urging residents to stay home. She also gave several high-profile interviews discussing the disproportionate impact of COVID-19 on black communities and emphasizing the importance of tracking demographic data. The city also encountered some challenges. Early on, it found that up to 30% of the testing data it collected didn’t list race. At the April 6 press conference, which came one day after a WBEZ news report detailed the death disparities, the city released a detailed race analysis. The city also issued a public health order mandating demographic data of COVID-19 cases be reported in hopes of being better able to track and assist individuals and communities falling victim to the coronavirus. Still, to some in the community, the city appeared a step behind. Niketa Brar, co-founder and executive director at Chicago United for Equity, which advocates for racial equity in the city, said officials didn’t do enough to engage the communities they knew would be hardest hit. As soon as the virus entered Chicago, she said, the city should have used racial, health and economic data to predict where it would take hold and then begin working with residents in those communities on how best to protect and support them. The Racial Equity Rapid Response Team was dispatched much later, she said. “We’ve seen enough maps to know what the next map is going to look like,” Brar said. “And yet we consistently fail to engage those who are closest to the harm time and time again.” Lightfoot said in an interview Friday she believes the city responded robustly to the virus from the start. “I feel pretty good about where we are,” she said. “Has it been perfect? Has any of this been perfect? No, because you’re not going to be able to undo literally 100-plus years of racial disparities across black and brown Chicago. But I’m going to be a champion for people in my city, and particularly people who look like me and who grew up in circumstances like mine.” The Perils of Connection It made sense that they were out on Election Day — Revall Burke, a 60-year-old city worker, who served as an election judge for the March 17 primary, and John J. Hill Jr., 53, who was campaigning for a friend outside of City Hall, handing out masks and shaking hands. Their community connections had shaped their lives. Both grew up in public housing. Burke went on to help form a building committee to give back to the neighborhood, including organizing picnics where he would give away school supplies. Hill, who built a successful business and counted among his proudest moments catering a campaign event for Barack Obama, met his wife at the iconic Rock ‘N’ Roll McDonald’s where she worked as a teenager. He came in to buy ice cream nearly every day; when she was sick, he got her a “get well soon” card signed “the ice cream man,” sparking a 40-year romance and two sons. For black residents in a city as segregated as Chicago, connections to family, church and community can be a vital resource. During the 1995 Chicago heat wave, connectedness sometimes meant the difference between life and death: Sociologists found that compared with more affluent neighborhoods, Auburn Gresham had fewer deaths, in part because residents knew their neighbors and checked on one another during the extreme temperatures, just as they did every day. Yet those deep connections put black Chicagoans in harm’s way as the novel coronavirus spread largely undetected, said Jaime Slaughter-Acey, a social epidemiologist at the University of Minnesota who did her doctoral work in Chicago. “What we’re seeing in the time of COVID is that this virus has taken this really important, health-promoting resource [of social connectivity] that we’ve created and used it against communities of color.” Both men died on April 1, two weeks after the election. The Chicago Department of Public Health and the CDC mapped one cluster of 16 known or suspected infections — and three deaths — dramatically illustrating the path the virus tore through families and friends who attended an intimate dinner, a funeral, a birthday celebration or a church service. Jennifer Layden, the department’s deputy commissioner, said the case study shows how insidious the virus could be in social settings — even a gathering of just three loved ones could be deadly. Eboney Harrell was aware of the risk and barred all visitors from stopping by after her daughter SaDariah brought home her newborn baby. A single mother, Harrell was an anchor for SaDariah, rarely leaving her side after she learned her daughter became pregnant. Harrell went to the doctors’ appointments and hosted a circus-themed baby shower with custom T-shirts; hers read “Grandma.” After her grandson was born at the University of Chicago Medical Center on March 19, she took every opportunity to hold him. Her friends believe she may have gotten the virus at the hospital. When it came time for Harrell to be the patient, nobody was allowed to be by her side. She died on April 4, alone. A bedside advocate is important for anyone in the medical system but especially the seriously ill. Sociologists say that, though critical, barring visitors during the pandemic to contain the virus may inadvertently magnify its deadly impact. Human connections had fueled Rosa Lynn Franklin’s recovery after she suffered a stroke several years ago. Though Franklin had to retire from her longtime career as a social worker in her native Alabama, she filled her days with family, friendships and prayer. She moved to Chicago last year to be near her only child, finding a new community in extended family and a church down the street. As COVID-19 encroached, Franklin, 64, became homebound, worried about how the virus might affect her fragile health. Despite all her precautions, she got sick, and by March 24, she was having such difficulty breathing that her daughter took her to the emergency room at University of Illinois Hospital. “Because of social distancing, you can’t really do a lot of touching,” her daughter Jimeria Williams said, “so I just kind of patted her on the back and said, ‘I love you, I’ll see you.’” Franklin was intubated the day after she was admitted, and while Williams was able to talk with the doctors, she could not communicate with her mother, not even by phone. It was the opposite of what had happened after the stroke, when Williams was a constant presence at her mother’s bedside. “I couldn’t be there to hold her hand. I know she knew that, even though she was unconscious,” she said. “I think that had a metaphysical impact on her health.” In the early evening of April 3, the hospital was able to connect Williams with her mother through FaceTime. A few minutes after hearing her daughter’s voice, Franklin died. Full Article
c DTC TV Pricing Rule Challenged By regulatoryrx.blogspot.com Published On :: Fri, 14 Jun 2019 20:21:00 +0000 SECOND UPDATE: On July 8, 2019, the judge issued an order setting aside the CMS rule. The full opinion is available here.UPDATE: On July 8, 2019, the judge in this suit is due to provide a ruling on whether the rule will take effect on July 9. The judge might issue a stay on the rule's implementation. For more details, see this report from MM&M.On June 14, 2019, Amgen, Merck, Lilly, and the Association of National Advertisers filed a complaint challenging the CMS rule requiring TV ads to include drug pricing information.Here's a link to the original complaint: https://drive.google.com/file/d/1w5I5kvuYIedGaFGOYzl_VtzZEDFGA7vQ/viewIf there is no action on this complaint, the rule will go into effect on July 9. Full Article Amgen ANA CMS Drug pricing DTC Lilly Merck MM&M TV
c Preparing for Pricing in DTC TV By regulatoryrx.blogspot.com Published On :: Tue, 02 Jul 2019 19:27:00 +0000 UPDATE 2: On August 21, 2019, the government filed a notice of appeal in this case.UPDATE: On July 8, 2019, the judge in the pending litigation described below issued an order setting aside the CMS rule. The full opinion is available here.If nothing changes, the new rule about including drug pricing in TV ads from CMS will go into effect one week from today on July 9, 2019.There are a few wrinkles to keep in mind as we approach this deadline. First, there's a lawsuit pending that could delay the rule's implementation. Second, the operational challenges of abiding by the rule are the biggest hurdle including the expanded 2253 filing requirements. Third, the rule's scope is still unclear. Fourth, the rule doesn't preclude or preempt the PhRMA Principles change from April. Finally, the overlapping but non-identical scope of the rules could lead to some confusion and compliance hiccups. This post addresses each of these points in turn.Pending LitigationAs I noted in a previous post, several pharmaceutical companies along with the Association of National Advertisers filed a complaint seeking to overturn the CMS rule. The full complaint is available here. The plaintiffs have filed a motion to stay the rule's implementation, and the judge has set a date of July 8 for issuing a decision. So, it is possible that companies will not actually be required to include their drug pricing in TV spots on July 9; however, as a practical matter, companies airing spots on July 9 and soon thereafter have most likely already developed them with the required pricing information included. All promotional materials for prescription drugs, biologics, and vaccines must be submitted to the FDA at time of initial dissemination or publication, so the FDA has most likely already begun receiving submissions of TV spots that include the information, and it is unlikely that a company would go to the time and expense of producing two versions of their TV spots (one with the pricing and one without) and submit both the FDA, only to determine on July 8 which spot to air the next day. Consequently, even if the judge issues a stay on the rule, there's a good chance that you'll see at least a few TV spots featuring pricing on July 9.And that points to one of the issues the rule raises: operational challenges.Operational Challenges Adding a line of copy to a TV ad is not a massive creative endeavor, and because the rule only requires the copy to appear on screen for a long enough time to be read, there are no audio implications, but the CMS rule requires that the pricing information presented is kept up to date. Specifically, the new rule requires that the pricing information provided be:"as determined on the first day of the quarter during which the advertisement is being aired or otherwise broadcast." 42 CFR 403.1202 (not yet live on the code of federal regulations itself).That means the pricing information must potentially be updated every quarter. Of course, most companies don't change their drug pricing quarterly, but it is common to have pricing updates twice per year. So, every time a company changes its pricing, it will have to determine what ads are currently airing and whether the pricing updates affect those ads. If the pricing changes affect the ads, then the ads will have to be updated. An updated TV ad both means an expense for the advertiser, but it also means a new 2253 filing with the FDA because updated materials must be resubmitted to the Agency.And that means that the media buyers placing the ads will have one additional wrinkle to keep in mind as they manage the ad placements. They'll need to make sure that as new pricing comes into affect and ads are updated that the old ads are removed from the rotation, lest they be placed on CMS's naughty list.That operational challenge is compounded by the fact that the scope of the rule is unclear, so it's not currently possible to say exactly what ads must include drug pricing.Rule Scope UnclearAs I noted in a previous post, CMS made it clear that the requirement to include pricing does not apply to ALL direct to consumer (DTC) ads, but only to a limited subset of DTC ads. Specifically, the new requirement applies to only ads that appear on broadcast, cable, satellite, and streaming television. Unfortunately, CMS never explained what "streaming television" is. I tried to find a definition somewhere but wasn't able to do so. This matters because there are tons of DTC video ads that MIGHT be considered subject to the rule that are definitely not presented on "broadcast, cable, or satellite television."Because of this scope unclarity, the operational challenges of managing ad inventory is compounded, and of course, companies must decide how to handle ads that are used on television when they appear in places where the pricing information is not required. It would certainly be easier to develop a version of the ad that doesn't require quarterly updates, but it also is easier to traffic fewer total ad units.CMS Rule Adds to (Doesn't Replace) PhRMA's Pricing RequirementsThe Pharmaceutical Research and Manufacturers of America (PhRMA) updated its Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines in October of 2018. The most significant change was the addition of a requirement for television ads to include a destination where people can find pricing information about the prescription drug being advertised. This requirement became operative in April of 2019. All members of PhRMA are obligated to follow the PhRMA guiding principles, and most companies that are not members of PhRMA also abide by the guiding principles. Consequently, almost all television commercials currently airing include a link to a webpage with pricing information.Adhering to the CMS rule does NOT meet the PhRMA guiding principles. Consequently, most companies will be providing both a link to a page with additional information and the pricing information required by CMS. We'll see how companies execute this, but my expectation is that a single screen at the end of a television commercial will accommodate both pieces of information.Of course, not all ads are required to include both pieces (or even either piece!) of information.Non-identical Overlapping ScopesThe new CMS rule applies to all advertised indications of a pharmaceutical product that are reimbursed via Medicare or Medicaid and whose cost is at least $35 per month (or for a typical course of treatment). 42 CFR 403.1200. Note that some drugs have multiple indications, where only some of the indications are reimbursed by CMS. For those products, only the ads that promote an indication reimbursed by CMS are required to include the pricing information; and only if the drug's list price is at least $35 per month (or for a typical course of treatment).By contrast, the PhRMA guiding principles apply to all ads for prescription medicines regardless of whether the drug is reimbursed by CMS and regardless of the cost. Of course, the guiding principles are only binding on members of PhRMA and any non-member companies that have chosen to abide by the guiding principles.TL;DRSome commercials (but we don't know exactly which ones) might start having pricing information in one week. The addition of this information is allegedly going to address the allegedly high price of prescription drugs. The only guaranteed aspect of the recent changes from PhRMA and CMS is that marketing and regulatory operations groups are going to have challenges ensuring ongoing compliance, and the FDA is about to start getting more 2253 filings, including a likely surge of revised television spots in the next few days. Full Article 2253 filing ad inventory Amgen ANA CMS Drug pricing Lily media buying Merck OPDP PhRMA
c Expanded Service Offerings By regulatoryrx.blogspot.com Published On :: Mon, 13 Jan 2020 18:26:00 +0000 PhillyCooke Consulting has added new services from the humble start more than five years ago, when I used to joke that the company included both me and my laptop.In addition to continuing to provide regulatory consulting services, PhillyCooke Consulting now offers:Submission Preparation Services for Ad AgenciesMedical EditingProofreading, and Medical Writing. You can learn a bit more about the expanded services here, or simply complete the "Contact Form" to request a free initial consultation.Also, having completed law school (and been admitted to the bar in Pennsylvania), I am now able to offer legal services; however, the law practice is distinct from PhillyCooke Consulting. If you are interested in legal services related to the advertising and promotion of FDA-regulated products, please see FDAadLaw.com, which is a sister corporation to PhillyCooke Consulting.Although the website is currently a bit spartan, the services offered are robust and address all aspects of advertising FDA-regulated products, including concerns related to the Lanham Act, privacy, and FDCA issues. Full Article
c DHC Privacy Post By regulatoryrx.blogspot.com Published On :: Thu, 16 Jan 2020 15:20:00 +0000 The Digital Health Coalition asked for my views on the renewed emphasis on privacy for pharmaceutical marketers. I shared a few thoughts here. Full Article Digital Health Coalition privacy
c Temple RA/QA Advertising Course By regulatoryrx.blogspot.com Published On :: Mon, 27 Jan 2020 14:41:00 +0000 It was just confirmed that I'll be teaching in Temple University's RA/QA MS program this spring. Specifically, I'll be teaching the ad-promo course.If you or anyone you know is interested, please reach out to me for information. The course will be taught out of the Fort Washington campus, but online enrollment is permitted.Here's the complete schedule of classes for the spring. Full Article RAQA teaching Temple University
c 2020 CDER Guidance Agenda Released By regulatoryrx.blogspot.com Published On :: Mon, 03 Feb 2020 14:54:00 +0000 UPDATE: The guidance mentioned below was released. Here's the link.The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers Also notable is that no other advertising or promotional guidances are listed. The draft guidance on presenting risk information turned 10 years old last year. It seemed ripe for an update and perhaps even finalization. That seemed even more likely in the context of OPDP's study of the so-called one-click rule. That study was first announced in 2017. There's no update on the FDA website about the study, but I expected it to be completed last year.FDA's social science research has clearly been influencing recent guidances, so I assumed (and continue to assume) that FDA would want to update the risk presentation guidance in light of its most recent research about presenting risks, including the one-click study. Apparently, we'll have to keep waiting.BTW, for those interested in the topic of biosimilar promotion, the Drug Information Association's Advertising & Promotion Regulatory Affairs Conference will have a session covering this topic. Full disclosure: I sit on the programming committee for the conference and will be leading the medical device primer the day before the full conference kicks off. Full Article biosimilars CDER DIA Guidance Guidance Agenda OPDP
c COVID-19 Outbreak Pausing Live Speaking Engagements By regulatoryrx.blogspot.com Published On :: Fri, 20 Mar 2020 17:26:00 +0000 I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands! Full Article COVID-19 DIA FDAnews RAPS
c COVID-19 & Ad-Promo By regulatoryrx.blogspot.com Published On :: Mon, 23 Mar 2020 19:34:00 +0000 The COVID-19 pandemic has brought to the fore some issues of ad-promo for FDA-regulated products. I'm posting here to highlight some developments and correct some of the discussion.Snake Oil & EnforcementOne of the unfortunate things about any new health concern is that the snake oil sales start immediately. There are far too many scumbags who see an opportunity to profit in a crisis. The COVID-19 outbreak is no exception.These people represent a real danger to the public. People who promote unproven treatments can convince the public that they don't need to take the outbreak seriously, can lead to reckless behavior, and in the extreme can contribute directly to increased deaths as their victims rely on the snake oil instead of trusting healthcare providers.In this setting, FDA and FTC enforcement is essential. We need vigorous enforcement from the authorities to stop the spread of misinformation. I'm glad to see FTC and FDA have already taken some action in this regard. I hope we'll see more.Off-Label Promotion & OutbreaksResearchers, practitioners, and industry are frantically searching for any effective treatments. Currently, the science is unclear about whether any treatment works.As I write this, there has been a lot of buzz around the possible effectiveness of an anti-malarial treatment, hydroxychloroquine sulfate. This is an already-approved drug being used for an unapproved indication, i.e., this is a classic off-label use of a product.I have seen some misinformation in the media about off-label uses of products, so I thought it might be helpful to set out the background to all of this.To bring a new drug to market, a company must submit a New Drug Application (NDA) to the FDA. Among other information, the NDA includes proposed labeling. The proposed labeling provides directions to healthcare providers explaining how to use the drug safely. That labeling sets out the proposed uses of the drug. The uses of the drug are known as the indications. Indications typically include a population, a condition, and the stage/severity of the condition (if applicable).The FDA evaluates the NDA to determine whether the sponsor has demonstrated that the drug is safe and effective for the proposed indications. Assuming the sponsor meets the evidentiary burden, the FDA approves the proposed indications for the product.After being approved by the FDA, sponsors may only promote their drugs for the specific indications approved by the Agency. Any other use of the product is "off-label" use.Off-label use is NOT inherently bad, wrong, or evil; and off-label use of a drug is also not prohibited. The other evening I heard a television news segment where the expert commentator spoke of using drugs in violation of FDA's rules. That's wrong.FDA does not regulate the practice of medicine, and physicians are, for the most part, able to prescribe drugs as they believe is appropriate to treat the patients they see.But the sponsors are not permitted to promote their drugs for any uses other than those approved by the FDA. Importantly, there is no explicit prohibition in law against the promotion of unapproved uses. You won't, for example, find off-label promotion listed as one of the items that causes a drug to be misbranded. Instead, there are multiple legal theories about this prohibition and what exactly makes such promotion illegal, including the failure to include adequate directions for use in the labeling.FDA has made it clear that it sees the continued prohibition of off-label promotion as essential to protect the public, despite some adverse judgments by some courts.If a company learns of a new off-label use for a drug and wants to promote the drug for that use, the sponsor must conduct additional clinical trials to demonstrate that the drug is also safe and effective for that new use. After completing the clinical trials, the sponsor submits an sNDA (supplemental New Drug Application) to the Agency.Assuming the Agency approves the sNDA, the label is updated to include the new indication, clinical trial data, additional instructions for use, etc., and the company is then able to promote the new use of the drug.So, FDA doesn't have to DO anything to make the possible off-label treatments available, despite several prominent people calling on FDA to take action. The drug being suggested for off-label use is already on the market and can be used for this off-label use.Why doesn't FDA simply approve the new use?Because FDA doesn't know if the drug works.When FDA evaluates an NDA or sNDA it weighs the risks and benefits of the drug for each specific proposed use. As FDA has repeatedly made clear, each specific proposed use requires a separate risk-benefit determination.It is possible (even likely) that a drug that has been proven to be safe and effective for one use might not be either safe or effective for another use.Indeed, one frequent criticism of off-label use of drugs is that there simply isn't sufficient evidence of effectiveness for many off-label uses.And that in turns leads directly to why FDA's prohibition on off-label promotion is so important to protect the public health. Using treatments without evidence and promoting such treatments can make things worse.FDA has the tools to act rapidly to approve new uses of a drug, but it is unwise to short-circuit the approval process, and it's irresponsible to hype an off-label use without sufficient evidence to demonstrate its efficacy. Full Article FDA FTC off-label
c Supplies of some COVID-19 medicines to run out within days, government warns By feeds.pjonline.com Published On :: Mon, 20 Apr 2020 14:39 GMT Supplies of certain drugs used when intubating patients with COVID-19 will run out “over the coming days”, the government has warned. To read the whole article click on the headline Full Article
c Pharmacies' dispensing increases by up to a third as a result of COVID-19, survey finds By feeds.pjonline.com Published On :: Tue, 21 Apr 2020 15:22 GMT Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association. To read the whole article click on the headline Full Article
c One in three pharmacists unable to access PPE, finds RPS survey By feeds.pjonline.com Published On :: Wed, 22 Apr 2020 14:05 GMT A third of pharmacists cannot obtain continuous supplies of personal protective equipment, according to a survey conducted by the Royal Pharmaceutical Society. To read the whole article click on the headline Full Article
c Myocardial injury associated with increased risk of death from COVID-19, research suggests By feeds.pjonline.com Published On :: Thu, 23 Apr 2020 11:37 GMT The development of myocardial injury in COVID-19 patients is associated with an increased risk of death, researchers have found. To read the whole article click on the headline Full Article
c Neurological symptoms common in COVID-19 patients, researchers say By feeds.pjonline.com Published On :: Fri, 24 Apr 2020 10:13 GMT Neurological symptoms are common in patients with COVID-19, particularly if they have a severe infection, research published in JAMA Neurology suggests. To read the whole article click on the headline Full Article
c Care home pharmacists redeployed, despite COVID-19 palliative care increase By feeds.pjonline.com Published On :: Fri, 24 Apr 2020 10:22 GMT Exclusive: Pharmacy staff in care homes are being redeployed to cover other roles during the COVID-19 pandemic, even though demands on care homes are increasing rapidly, The Pharmaceutical Journal has learnt. To read the whole article click on the headline Full Article
c Manufacturers report 'sporadic' resupply of sertraline following COVID-19 related shortage By feeds.pjonline.com Published On :: Fri, 24 Apr 2020 16:32 GMT Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. To read the whole article click on the headline Full Article
c Apixaban may be more effective and safer than rivaroxaban, research suggests By feeds.pjonline.com Published On :: Mon, 27 Apr 2020 13:15 GMT Adults with non-valvular atrial fibrillation prescribed apixaban have a lower rate of ischaemic stroke and systemic blood clots compared with those prescribed rivaroxaban, according to a retrospective cohort study in Annals of Internal Medicine. To read the whole article click on the headline Full Article
c Pharmacy staff who have died during COVID-19 pandemic to be remembered during minute's silence By feeds.pjonline.com Published On :: Tue, 28 Apr 2020 09:49 GMT Pharmacy staff who are thought to have died as a result of the COVID-19 pandemic are to be among the healthcare workers remembered with a minute’s silence on 28 April 2020. To read the whole article click on the headline Full Article
c Pharmacists will not be automatically included in government COVID-19 life assurance scheme By feeds.pjonline.com Published On :: Tue, 28 Apr 2020 16:21 GMT Pharmacists will not be automatically eligible for a new government life assurance scheme for healthcare workers in England who die from COVID-19 during the pandemic. To read the whole article click on the headline Full Article
c Community pharmacies need £200m extra to stay afloat during COVID-19, trade body warns By feeds.pjonline.com Published On :: Wed, 29 Apr 2020 14:21 GMT Community pharmacies need millions of pounds extra “to keep their heads above water” during the COVID-19 pandemic, pharmacy bodies have warned. To read the whole article click on the headline Full Article
c COVID-19 updates: 5 April 2020 – 30 April 2020 By feeds.pjonline.com Published On :: Thu, 30 Apr 2020 11:43 GMT All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen. To read the whole article click on the headline Full Article
c Transcending boundaries: the role of pharmacists in gender identity services By feeds.pjonline.com Published On :: Thu, 30 Apr 2020 14:42 GMT There has been a surge in demand for gender identity services in the UK over the past five years. Although the current role of pharmacists is limited, their potential contribution within a multidisciplinary team supporting transgender patients is beginning to emerge. To read the whole article click on the headline Full Article
c Community pharmacists will now be included in COVID-19 death-in-service scheme By feeds.pjonline.com Published On :: Thu, 30 Apr 2020 15:30 GMT Community pharmacists are to be included in the government life assurance scheme for staff working on the frontline of the COVID-19 pandemic, the health secretary, Matt Hancock has announced. To read the whole article click on the headline Full Article
c Wholesalers 'almost completely out' of government-supplied PPE, trade body warns By feeds.pjonline.com Published On :: Fri, 1 May 2020 10:30 GMT Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned. To read the whole article click on the headline Full Article
c Manufacturer to move hydroxychloroquine production to the UK to avoid shortages By feeds.pjonline.com Published On :: Tue, 5 May 2020 15:41 GMT A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages. To read the whole article click on the headline Full Article
c Everything you should know about the coronavirus outbreak By feeds.pjonline.com Published On :: Wed, 6 May 2020 10:44 GMT The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public. To read the whole article click on the headline Full Article
c NHS England advises pharmacies to 'risk assess' BAME staff for susceptibility to COVID-19 By feeds.pjonline.com Published On :: Wed, 6 May 2020 12:29 GMT NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background. To read the whole article click on the headline Full Article
c COVID-19 LATEST: Valproate reviews must not be delayed, says medicines regulator By feeds.pjonline.com Published On :: Thu, 7 May 2020 00:01 GMT All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen. To read the whole article click on the headline Full Article
c Just 550 pharmacy staff referred for COVID-19 testing in first ten days of national scheme By feeds.pjonline.com Published On :: Thu, 7 May 2020 16:26 GMT Just over 550 community pharmacy staff members were referred for COVID-19 tests through a national booking system run by the Care Quality Commission, over ten days in mid-April 2020, the NHS watchdog has told The Pharmaceutical Journal. To read the whole article click on the headline Full Article
c In Surprise Move, SCOTUS to Rule on Constitutionality of ACA Next Term By cohealthcom.org Published On :: Wed, 04 Mar 2020 22:22:16 +0000 March 4, 2020 — The U.S. Supreme Court delivered a surprise on March 2 when it announced it will hear a challenge to the constitutionality of the Affordable Care Act (ACA) next term, leap-frogging over the process that was playing out in lower courts. Oral arguments have not yet been scheduled, but are likely to […] Full Article Courts/First Amendment ACA Affordable Care Act Jon Bigelow sunshine act Supreme Court U.S. Supreme Court
c Rising Leaders Conference Set for Nov. 18-19: Reserve Your Place Today! By cohealthcom.org Published On :: Thu, 12 Mar 2020 16:23:00 +0000 March 12, 2020 —[Note: Due to the coronavirus epidemic, the Conference has been rescheduled from May.] Healthcare was already the top issue for voters—and the coronavirus pandemic only intensifies the focus heading into a hotly-contested election. Both parties want to “do something” about the cost of healthcare and especially drug prices, and what happens when […] Full Article CHC News
c FDA and FTC: Coronavirus Products Are Fraudulent, Could Delay Treatment By cohealthcom.org Published On :: Mon, 16 Mar 2020 19:02:11 +0000 March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […] Full Article Regulatory/FDA Coronavirus COVID-19 FDA FDA commissioners FDA enforcement FTC Jon Bigelow PURELL unapproved drug Warning Letter
c Amid COVID-19 Outbreak, Protecting 2020 Election Should Start Now By cohealthcom.org Published On :: Mon, 23 Mar 2020 18:06:21 +0000 March 23, 2020 – As the United States grapples with the COVID-19 outbreak and its ongoing fallout, there is another pressing issue that is crucial to the American public: ensuring safe and fair elections between now and Nov. 3. “The Coalition believes it is important for all Americans to be active in the political process […] Full Article General 2020 election Amy Klobuchar Coronavirus COVID-19 early voting election day Jon Bigelow mail-in voting Ron Wyden voting
c Emergency Relief Package Yields Increased FDA Funding, OTC Revisions By cohealthcom.org Published On :: Mon, 30 Mar 2020 16:04:19 +0000 March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […] Full Article Legislative Congress Coronavirus COVID-19 emergency relief fda funding Jon Bigelow OTC regulation OTC user fees President Trump sunscreen
c CHC Endorses Request Calling for Veto of Maryland Tax on Digital Advertising By cohealthcom.org Published On :: Mon, 06 Apr 2020 19:23:10 +0000 April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […] Full Article Legislative chc coalition for healthcare communication digital advertising Gov. Larry Hogan HB 732 Jon Bigelow Maryland the advertising coalition
c FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims By cohealthcom.org Published On :: Mon, 13 Apr 2020 19:38:22 +0000 April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […] Full Article Regulatory/FDA clinical trials COVID-19 FDA FDA approval process FDA enforcement FTC Jon Bigelow promoting unapproved drug unapproved drug Warning Letter
c Despite Late Changes and COVID-19, CCPA Enforcement Date Remains July 1 By cohealthcom.org Published On :: Mon, 20 Apr 2020 21:01:00 +0000 April 20, 2020 – With additional changes to the regulations still in administrative review and businesses grappling with pressing COVID-19 issues, a group of nearly 100 advertising trade associations, organizations and companies asked California Attorney General Xavier Becerra (D) to delay the July 1 enforcement date for the California Consumer Protection Act (CCPA). But it […] Full Article Data Privacy 4A's Alison Pepper ANA California Consumer Protection Act CCPA Dan Jaffe data privacy data privacy legislation Gavin Newsom Jon Bigelow online data privacy Xavier Becerra
c COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines By cohealthcom.org Published On :: Mon, 27 Apr 2020 17:50:36 +0000 April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […] Full Article Regulatory/FDA Biohaven Bristol-Myers Squibb clinical trials COVID-19 drug approvals FDA approval process FDA Approvals
c As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds By cohealthcom.org Published On :: Mon, 04 May 2020 20:17:45 +0000 May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […] Full Article Regulatory/FDA COVID-19 FDA FDA enforcement fraud FTC Jon Bigelow promoting unapproved drug scams Warning Letter
c EMA starts reviewing Gilead's remdesivir data to accelerate approval of COVID-19 antiviral By www.fiercebiotech.com Published On :: Fri, 01 May 2020 08:07:12 +0000 The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients. Full Article
c COVID-19 the focus, but Pfizer isn't ignoring other vaccine R&D as its pens new deal By www.fiercebiotech.com Published On :: Fri, 01 May 2020 08:47:53 +0000 Pfizer and partner BioNTech are right in the middle of one of the most important vaccine trials in the world right now, but that doesn’t mean the Big Pharma is taking its eyes off the inoculation ball elsewhere. Full Article
c COVID-19: T cells offer clues to the potential power of Roche's Actemra By www.fiercebiotech.com Published On :: Fri, 01 May 2020 11:56:40 +0000 The successful activation of T cells is critical to the immune system's ability to clear infections. A retrospective study in China found that COVID-19 patients had remarkably low T-cell counts in their blood, while some pro-inflammatory cytokines such as IL-6—which Roche’s Actemra targets—were elevated. Full Article
c Inovio's COVID-19 vaccine claims echo Theranos, says short attack By www.fiercebiotech.com Published On :: Fri, 01 May 2020 12:32:30 +0000 Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine. Full Article
c Newron ditches sarizotan program after pivotal trial flop, sees shares crater By www.fiercebiotech.com Published On :: Mon, 04 May 2020 07:54:54 +0000 Newron will terminate work on its experimental Rett syndrome drug sarizotan after a complete failure in its pivotal STARS trial. Full Article
c Lilly-partnered AbCellera gets COVID-19 boost from Canadian government By www.fiercebiotech.com Published On :: Mon, 04 May 2020 09:43:23 +0000 After penning a deal with Eli Lilly last month with the aim to have an antibody in the clinic within four months, Canadian-based AbCellera has been given a financial boost by its government. Full Article
c Alnylam, Vir plan year-end trial of new RNAi COVID-19 antiviral By www.fiercebiotech.com Published On :: Mon, 04 May 2020 12:34:58 +0000 Alnylam and Vir Biotechnology have identified an anti-SARS-CoV-2 development candidate, putting them on track to start testing the inhaled RNAi treatment for COVID-19 in humans around the end of the year. Full Article