Sunday, July 12, 2020

The St. Louis couple who threatened Black Lives Matter protesters with guns once made children cry after destroying their bee hives

Gabbi Shaw THE INSIDER
Patricia McCloskey and her husband Mark McCloskey draw their firearms on protestors. Lawrence Bryant/File Photo/Reuters

RACIST HOMOPHOBIC ANTI SEMITES IN OTHER WORDS PERFECTLY NORMAL WASP'S (WHITE ANGLO SAXON PROTESTANTS)

On June 28, St. Louis couple Mark and Patricia McCloskey drew national attention when they brandished guns at Black Lives Matter protesters walking down their street.

An article by the St. Louis Post-Dispatch revealed the McCloskeys, both personal injury attorneys, have "nearly constantly sued other people and ordered people off their property," threatened neighbors at gunpoint and more.

One incident in 2013 involved Mark, the neighboring Jewish Central Reform 
Congregation, and beehives that he smashed. He threatened to sue the synagogue, obtain a restraining order, and seek legal fees if the mess wasn't cleaned up.

The beehives were part of the Hebrew school's curriculum, and the congregation was planning on harvesting honey to partake in a Rosh Hashanah tradition. The children cried as a result, according to the temple's rabbi.



The McCloskeys have been receiving more and more attention since they first went viral at the end of June for brandishing their guns at Black Lives Matter protesters who marched down their street — even the President retweeted a video of the couple.

They claim they support Black Lives Matter, and instead blamed the actions of a few agitators for their fear. "The Black Lives Matters movement is here to stay, its the right message, and it is about time," Albert Watkins, their attorney, said in a statement.

"The McCloskeys want to make sure no one thinks less of BLM, its message and the means it is employing to get its message out because of the actions of a few white individuals who tarnished a peaceful protest."

A prosecutor is currently investigating if the McCloskeys broke state law. As Insider previously reported, Missouri law says a person "commits the offense of unlawful use of weapons" if "he or she knowingly exhibits, in the presence of one or more persons, any weapon readily capable of lethal use in an angry or threatening manner."
The McCloskeys. Associated Press

An investigation done by the St. Louis Dispatch-Post revealed that the McCloskeys have a long history of legal action, conflicts with their neighbors, and even threatened to obtain a restraining order against the Jewish synagogue next door.

The article explains that, in 2013, the Jewish Central Reform Congregation constructed beehives just outside the McCloskey's mansion's northern wall. Their plan was to harvest the honey with the congregation's children to partake in the traditional Rosh Hashanah tradition of eating apples and honey to ensure a "sweet new year."

However, these plans were ruined when Mark McCloskey destroyed the beehives and left a note stating, among other things, that the "structure constitutes a trespass," and threatened that, if the beehives were cleaned up, "a restraining order will be obtained, and we will seek damages and attorneys' fees."

"The children were crying in school," Rabbi Susan Talve told the Dispatch. "It was part of our curriculum."

The McCloskeys have also had various confrontations with other neighbors. Patricia was impeached from the neighborhood's trustee association in 1992 when the other trustees accused her of being homophobic. She was fighting to enforce a rule that prohibited unmarried couples from moving into Portland Place — her husband claimed it wasn't about gay couples, just any unmarried couple.

"They've always been part of the problem, never part of the solution," said one neighbor, Robert Dolgin.

Wild bison to roam England's woodlands for the first time in 6,000 years as 'ecosystem engineers'
Sophia Ankel and Julian Kossoff

Lowland European bison grazes in the Bialowieza Primeval Forest, Poland. July 2009. They are the closest relative to the now extinct steppe bison that once roamed the ancient Britain. REUTERS/Peter Andrews

A herd of bison released in southern England will be the first bison to return to England 6,000 years after their ancestors became extinct.

Environmentalists say bison are a "keystone species" that can naturally manage woodlands.

European bison imported from Poland and the Netherlands will form the core of the new herd.

Beavers have already been successfully reintroduced into the UK and there are discussions about releasing other extinct species, including wild lynx and even wolves.


A herd of wild bison will be released in southern England for the first time in 6,000 years to help restore an ancient habitat and its surrounding wildlife, according to conservationists.

The move is part of a £1m project ($1.2 million) led by Kent Wildlife Trust and the Wildwood Trust, which aims to restore Blean Woods — a former pine wood plantation — near Canterbury.

The animals will be welcomed to their new home in the spring of 2022, with conservationists planning to first set free one male and three females to form the core of the new herd, according to the Guardian. The animals will be imported from Poland and the Netherlands — countries where previous releases have proven successful.

Conservationists hope that the move will help secure the future of the endangered species and that Europe's largest land mammal will also help naturally regenerate the area.

Wild bison fell trees by eating their bark or rubbing up against them. This will create wide and sunny clearings, which in turn will help native plants to thrive.

"The Wilder Blean project will prove that a wilder, nature-based solution is the right one to tackle the climate and nature crisis we now face," Paul Hadaway, of Kent Wildlife Trust said, according to the BBC.

"Using missing keystone species like bison to restore natural processes to habitats is the key to creating bio-abundance in our landscape." What the Trust calls "ecosystem engineering."

The European bison is the closest living relative to the ancient steppe bison, which existed in the UK 6,000 years ago before it was killed off due to hunting.

A team of conservationists will be working over the next 18 months to create a fenced enclosure within a wider 150 hectare (370 acres) area.

The public will be able to visit the area with rangers once the wild animals are settled. "This will allow people to experience nature in a way they haven't before," Hadaway said.

Over the centuries, Britain has lost many of its keystone species. But there is a growing re-wilding movement advocating for the reintroduction of large mammals and birds of prey driven to extinction by hunting and habitat loss.

Beavers, last recorded in the 16th century, were successfully reintroduced in 2009 and several populations now thrive around the country.

A Lynx UK Trust has been set up and wants to release the Eurasian lynx into forests in Scotland and the north of England to help keep down deer numbers.

The return of the wolf is perhaps the most controversial suggestion. Plans to release two packs withing a fenced range in Britain's wildest region in northern Scotland have been greeted with horror by walkers and farmers alike.
Trump rips private Texas border wall built by his supporters

MEXICO STILL AIN'T PAYING FOR IT
HOUSTON (AP) — President Donald Trump on Sunday criticized a privately built border wall in South Texas that’s showing signs of erosion months after going up, saying it was “only done to make me look bad,” even though the wall was built after a months-long campaign by his supporters.

The group that raised money online for the wall promoted itself as supporting Trump during a government shutdown that started in December 2018 because Congress wouldn’t fund Trump’s demands for a border wall. Called “We Build the Wall,” the group has raised more than $25 million promoting itself as supporting the president.

Former Trump chief strategist Steve Bannon joined the group’s board and Trump ally Kris Kobach became its general counsel. Kobach is now seeking the Republican nomination for U.S. Senate in Kansas.

The company that built the private section in January, North Dakota-based Fisher Industries, has since won a $1.3 billion border wall contract from the federal government, the largest award to date.

The section in question is a roughly 3-mile (5-kilometer) fence of steel posts just 35 feet (10 meters) from the Rio Grande, the river that forms the U.S.-Mexico border in Texas. That’s much closer to the river than the government ordinarily builds border barriers in South Texas because of concerns about erosion and flooding that could violate U.S. treaty obligations with Mexico.

Trump tweeted Sunday in response to a ProPublica-Texas Tribune report that the riverbank has started to erode. A federal judge on Wednesday ordered attorneys for Fisher Industries and opponents of the private wall to set a schedule for experts to visit the site and inspect any erosion.

“I disagreed with doing this very small (tiny) section of wall, in a tricky area, by a private group which raised money by ads,” Trump wrote. “It was only done to make me look bad, and perhsps it now doesn’t even work. Should have been built like rest of Wall, 500 plus miles.”

Tommy Fisher, CEO of Fisher Industries, said Sunday that he thought the president “just got some misinformation on this stuff” and that he had “complete respect” for Trump.

Fisher acknowledged that there had been some erosion on the land in front of the fencing caused by rain and the natural flow of the river. He said his crews planned to install more organic material to fill the gaps or insert rock if erosion continues, but that other parts of the wall remained untouched.

“The wall will stand for 150 years, you mark my words,” Fisher said.

Experts and people who live and work near the property have warned that building so close to the river would cause flooding or a break in the fence. And a binational commission earlier this year found that the project violates U.S. treaty obligations and called on Fisher to make changes.

Marianna Trevino Wright, executive director of the nonprofit National Butterfly Center, has long opposed the project and warned it could damage the center, which is adjacent to where the private wall was being built.

“It is troubling that President Trump admits to prior knowledge of this project — one he should have insisted comply with U.S. law, rather than proceed in violation of it,” she said Sunday.

Originally promoted by We Build the Wall, the private section instead became a showcase for Fisher, who has promoted his company heavily on Fox News and conservative media. We Build the Wall ultimately provided about $1.5 million for the project and Kobach said in a previous court hearing that his group was mostly providing “social media cheerleading.” We Build the Wall’s founder, Brian Kolfage, did not return a phone message Sunday.

In May, Fisher Industries won a $1.3 billion contract to build 42 miles (68 kilometers) of wall in Arizona. The wall will be painted black because “that’s what the president wanted, plain and simple,” said U.S. Sen. Kevin Cramer, a North Dakota Republican, in May. Cramer said then that he personally pitched the company to Trump.

Another $400 million contract Fisher won last year was placed under review by the defense department’s inspector general.
‘Desperation science’ slows the hunt for coronavirus drugs

Doris Kelley, 57, sits in her home on Monday, June 29, 2020 in Ruffs Dale, Pa. Kelley was one of the first patients in a University of Pittsburgh Medical Center trial for COVID-19. “It felt like someone was sitting on my chest and I couldn’t get any air,” Kelley said of the disease. (AP Photo/Justin Merriman)

In this photo provided by the UPMC, Doris Kelley, 57, participates in a teleconference interview with The Associated Press at the UPMC East hospital in Monroeville, Pa., on April 17, 2020. 

Desperate to solve the deadly conundrum of COVID-19, the world is clamoring for fast answers and solutions from a research system not built for haste.

The ironic, and perhaps tragic, result: Scientific shortcuts have slowed understanding of the disease and delayed the ability to find out which drugs help, hurt or have no effect at all.

As deaths from the coronavirus relentlessly mounted into the hundreds of thousands, tens of thousands of doctors and patients rushed to use drugs before they could be proved safe or effective. A slew of low-quality studies clouded the picture even more.

“People had an epidemic in front of them and were not prepared to wait,” said Dr. Derek Angus, critical care chief at the University of Pittsburgh Medical Center. “We made traditional clinical research look so slow and cumbersome.”

It wasn’t until mid-June — nearly six months in — when the first evidence came that a drug could improve survival. Researchers in the United Kingdom managed to enroll one of every six hospitalized COVID-19 patients into a large study that found a cheap steroid called dexamethasone helps and that a widely used malaria drug does not. The study changed practice overnight, even though results had not been published or reviewed by other scientists.

In this photo provided by the UPMC, Dr. Ruba Nicola, chairwoman of family medicine at UPMC East, adjusts her personal protective equipment at the UPMC East hospital in Monroeville, Pa., on April 17, 2020. The University of Pittsburgh Medical Center’s 40 hospitals in Pennsylvania, New York, Maryland and Ohio joined a study underway in the United Kingdom, Australia and New Zealand that randomly assigns patients to one of dozens of possible treatments and uses artificial intelligence to adapt treatments, based on the results. (UPMC via AP)

In the United States, one smaller but rigorous study found a different drug can shorten recovery time for seriously ill patients, but many questions remain about its best use.

Doctors are still frantically reaching for anything else that might fight the many ways the virus can do harm, experimenting with medicines for stroke, heartburn, blood clots, gout, depression, inflammation, AIDS, hepatitis, cancer, arthritis and even stem cells and radiation.

“Everyone has been kind of grasping for anything that might work. And that’s not how you develop sound medical practice,” said Dr. Steven Nissen, a Cleveland Clinic researcher and frequent adviser to the U.S. Food and Drug Administration. “Desperation is not a strategy. Good clinical trials represent a solid strategy.”

Few definitive studies have been done in the U.S., with some undermined by people getting drugs on their own or lax methods from drug companies sponsoring the work.

And politics magnified the problem. Tens of thousands of people tried a malaria medicine after President Donald Trump relentlessly promoted it, saying, “What have you got to lose?” Meanwhile, the nation’s top infectious disease expert, Dr. Anthony Fauci, warned “I like to prove things first.” For three months, weak studies polarized views of hydroxychloroquine until several more reliable ones found it ineffective.

“The problem with ‘gunslinger medicine,’ or medicine that is practiced where there is a hunch ... is that it’s caused society as a whole to be late in learning things,” said Johns Hopkins University’s Dr. Otis Brawley. “We don’t have good evidence because we don’t appreciate and respect science.”

He noted that if studies had been conducted correctly in January and February, scientists would have known by March if many of these drugs worked.

Even researchers who value science are taking shortcuts and bending rules to try to get answers more rapidly. And journals are rushing to publish results, sometimes paying a price for their haste with retractions.

Research is still chaotic — more than 2,000 studies are testing COVID-19 treatments from azithromycin to zinc. The volume might not be surprising in the face of a pandemic and a novel virus, but some experts say it is troubling that many studies are duplicative and lack the scientific rigor to result in clear answers.

“Everything about this feels very strange,” said Angus, who is leading an innovative study using artificial intelligence to help pick treatments. “It’s all being done on COVID time. It’s like this new weird clock we’re running on.”

Here is a look at some of the major examples of “desperation science” underway.


A MALARIA DRUG GOES VIRAL

To scientists, it was a recipe for disaster: In a medical crisis with no known treatment and a panicked population, an influential public figure pushes a drug with potentially serious side effects, citing testimonials and a quickly discredited report of its use in 20 patients.

Trump touted hydroxychloroquine in dozens of appearances starting in mid-March. The Food and Drug Administration allowed its emergency use even though studies had not shown it safe or effective for coronavirus patients, and the government acquired tens of millions of doses.

Trump first urged taking it with azithromycin, an antibiotic that, like hydroxychloroquine, can cause heart rhythm problems. After criticism, he doubled down on giving medical advice, urging “You should add zinc now ... I want to throw that out there.” In May, he said he was taking the drugs himself to prevent infection after an aide tested positive.

Many people followed his advice.

Dr. Rais Vohra, medical director of a California poison control center, told of a 52-year-old COVID-19 patient who developed an irregular heartbeat after three days on hydroxychloroquine – from the drug, not the virus.

“It seems like the cure was more dangerous than the effects of the disease,” Vohra said.

Studies suggested the drug wasn’t helping, but they were weak. And the most influential one, published in the journal Lancet, was retracted after major concerns arose about the data.

Craving better information, a University of Minnesota doctor who had been turned down for federal funding spent $5,000 of his own money to buy hydroxychloroquine for a rigorous test using placebo pills as a comparison. In early June, Dr. David Boulware’s results showed hydroxychloroquine did not prevent COVID-19 in people closely exposed to someone with it.

A UK study found the drug ineffective for treatment, as did other studies by the U.S. National Institutes of Health and the World Health Organization.

Boulware’s colleague, Dr. Rahda Rajasingham, aimed to enroll 3,000 health workers in a study to see if hydroxychloroquine could prevent infection, but recently decided to stop at 1,500.

When the study started, “there was this belief that hydroxychloroquine was this wonder drug,” Rajasingham said. More than 1,200 people signed up in just two weeks, but that slowed to a trickle after some negative reports.

“The national conversation about this drug has changed from everyone wants this drug ... to nobody wants anything to do with it,” she said. “It sort of has become political where people who support the president are pro-hydroxychloroquine.”

Researchers just want to know if it works.

LEARN AS YOU GO

In Pittsburgh, Angus is aiming for something between Trump’s “just try it” and Fauci’s “do the ideal study” approach.

In a pandemic, “there has to be a middle road, another way,” Angus said. “We do not have the luxury of time. We must try to learn while doing.”

The University of Pittsburgh Medical Center’s 40 hospitals in Pennsylvania, New York, Maryland and Ohio joined a study underway in the United Kingdom, Australia and New Zealand that randomly assigns patients to one of dozens of possible treatments and uses artificial intelligence to adapt treatments, based on the results. If a drug looks like a winner, the computer assigns more people to get it. Losers are quickly abandoned.

The system “learns on the fly, so our physicians are always betting on the winning horse,” Angus said.

A small number of patients given usual care serve as a comparison group for all of the treatments being tested, so more participants wind up getting a shot at trying something.

Mark Shannon, a 61-year-old retired bank teller from Pittsburgh, was the first to join.

“I knew that there was no known cure. I knew that they were learning as they went along in many cases. I just put my trust in them,” he said.

Shannon, who spent 11 days on a breathing machine, received the steroid hydrocortisone and recovered.

Doris Kelley, a 57-year-old preschool teacher in Ruffs Dale, southeast of Pittsburgh, joined the study in April.

“It felt like someone was sitting on my chest and I couldn’t get any air,” Kelley said of COVID-19.

She has asthma and other health problems and was glad to let the computer choose among the many possible treatments. It assigned her to get hydroxychloroquine and she went home a couple days later.

It’s too soon to know if either patient’s drug helped or if they would have recovered on their own.

THE BUMPY ROAD TO REMDESIVIR

When the new coronavirus was identified, attention swiftly turned to remdesivir, an experimental medicine administered through an IV that showed promise against other coronaviruses in the past by curbing their ability to copy their genetic material.

Doctors in China launched two studies comparing remdesivir to the usual care of severely and moderately ill hospitalized patients. The drug’s maker, Gilead Sciences, also started its own studies, but they were weak -- one had no comparison group and, in the other, patients and doctors knew who was getting the drug, which compromises any judgments about whether it works.

The NIH launched the most rigorous test, comparing remdesivir to placebo IV treatments. While these studies were underway, Gilead also gave away the drug on a case-by-case basis to thousands of patients.

In April, Chinese researchers ended their studies early, saying they could no longer enroll enough patients as the outbreak ebbed there. In a podcast with a journal editor, Fauci gave another possible explanation: Many patients already believed remdesivir worked and were not willing to join a study where they might end up in a comparison group. That may have been especially true if they could get the drug directly from Gilead.

In late April, Fauci revealed preliminary results from the NIH trial showing remdesivir shortened the time to recovery by 31% — 11 days on average versus 15 days for those just given usual care.

Some criticized releasing those results rather than continuing the study to see if the drug could improve survival and to learn more about when and how to use it, but independent monitors had advised that it was no longer ethical to continue with a placebo group as soon as a benefit was apparent.

Until that study, the only other big, rigorous test of a coronavirus treatment was from China. As that country rushed to build field hospitals to deal with the medical crisis, doctors randomly assigned COVID-19 patients to get either two HIV antiviral drugs or the usual care and quickly published results in the New England Journal of Medicine.

“These investigators were able to do it under unbelievable circumstances,” the journal’s top editor, Dr. Eric Rubin, said on a podcast. “It’s been disappointing that the pace of research has been quite slow since that time.”

WHY SCIENCE MATTERS

By not properly testing drugs before allowing wide use, “time and time again in medical history, people have been hurt more often than helped,” Brawley said.

For decades, lidocaine was routinely used to prevent heart rhythm problems in people suspected of having heart attacks until a study in the mid-1980s showed the drug actually caused the problem it was meant to prevent, he said.

Alta Charo, a University of Wisconsin lawyer and bioethicist, recalled the clamor in the 1990s to get insurers to cover bone marrow transplants for breast cancer until a solid study showed they “simply made people more miserable and sicker” without improving survival.

Writing in the Journal of the American Medical Association, former FDA scientists Drs. Jesse Goodman and Luciana Borio criticized the push to use hydroxychloroquine during this pandemic and cited similar pressure to use an antibody combo called ZMapp during the 2014 Ebola outbreak, which waned before that drug’s effectiveness could be determined. It took four years and another outbreak to learn that ZMapp helped less than two similar treatments.

During the 2009-2010 swine flu outbreak, the experimental drug peramivir was widely used without formal study, Drs. Benjamin Rome and Jerry Avorn of Brigham and Women’s Hospital in Boston noted in the New England Journal. The drug later gave disappointing results in a rigorous study and ultimately was approved merely for less serious cases of flu and not severely ill hospitalized patients.

Patients are best served when we stick to science rather than “cutting corners and resorting to appealing yet risky quick fixes,” they wrote. The pandemic will do enough harm, and damage to the system for testing and approving drugs “should not be part of its legacy.”

___

Marilynn Marchione can be followed on Twitter: @MMarchioneAP

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
US bets on untested company to deliver COVID-19 vaccine


FILE - In this March 16, 2020, file photo, a patient receives a shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, at the Kaiser Permanente Washington Health Research Institute in Seattle. When precious vats of COVID-19 vaccine are finally ready, the ability to jab the lifesaving solution into the arms of Americans will require hundreds of millions of injections. (AP Photo/Ted S. Warren, File)

When precious vats of COVID-19 vaccine are finally ready, jabbing the lifesaving solution into the arms of Americans will require hundreds of millions of injections.

As part of its strategy to administer the vaccine as quickly as possible, the Trump administration has agreed to invest more than half a billion in tax dollars in ApiJect Systems America, a young company. Its injector is not approved by federal health authorities and the company hasn’t yet set up a factory to manufacture the devices.

The commitment to ApiJect dwarfs the other needle orders the government has placed with a major manufacturer and two other small companies.
This undated image provided by ApiJect Systems America in July 2020 shows a prototype of their "BFS" prefilled syringe. The devices are self-contained: the soft plastic blister is squeezed to push a dosage through the attached needle to inject into a patient. It also includes a computer chip that can transmit information about the drug, dose, location and time of administration. When precious vats of COVID-19 vaccine are finally ready, the ability to jab the lifesaving solution into the arms of Americans will require hundreds of millions of injections. The Trump administration  has agreed to invest more than half a billion in tax dollars in ApiJect Systems America, a young company whose injector is not approved by federal health authorities and who hasn’t yet set up a factory to manufacture the unapproved devices. (ApiJect Systems America via AP)
___

EDITOR’S NOTE -- This story is part of an ongoing investigation by The Associated Press, the PBS series FRONTLINE and the Global Reporting Centre that examines the deadly consequences of the fragmented worldwide medical supply chain.
Full Coverage: Deadly Shortages

___


“The fact of this matter is, it would be crazy for people to just rely on us. I would be the first to say it,” said ApiJect CEO Jay Walker. “We should be America’s backup at this point, but probably not its primary.”

Trump administration officials would not say why they are investing so heavily in ApiJect’s technology. The company has made only about 1,000 prototypes to date, and it’s not clear whether those devices can deliver the vaccines that are currently in development. So far, the leading candidates are using traditional vials to hold the vaccine, and needles and syringes in their clinical trials.

RELUCTANT SUPPLIER

ApiJect founder Marc Koska never intended to vaccinate the United States. For the past five years, he’s been working on his lifetime mission of creating an ultra low-cost prefilled syringe that would reduce the need to reuse needles in the developing world.

Instead, the company’s biggest customer has become the U.S. government.

ApiJect received a no-bid contract earlier this year from the Defense Department under an exception for “unusual and compelling urgency.” Authorities said the U.S. Department of Health and Human Services, tasked with buying the necessary supplies, “does not have the resources or capacity to conduct procurements necessary to respond to the COVID-19 pandemic,” according to a June 5 military document.

The government promised ApiJect $138 million to produce 100 million of its devices by the end of the year, which will require the company to retrofit new manufacturing lines in existing factories. And it’s offered another $456 million as part of a public-private partnership contract to bring online several new factories to make another 500 million devices to “contain the pandemic spread to minimize the loss of life and impact to the United States economy,” said the document.

These amounts are more than double the per-syringe cost the government is paying other companies for the work.

ApiJect first appeared on the U.S. government’s radar almost two years ago when the company piqued the interest of Admiral Brett P. Giroir, HHS’s assistant secretary for health, at the World Health Organization’s Global Conference on Primary Health Care in Astana, Kazakhstan.

Koska said Giroir was “blown away” by their technology and told them that if a pandemic hit, the strategic national stockpile was going to need a very fast way to get injections filled with vaccines or therapeutics and ready to deliver.

According to Walker, the CEO, ApiJect wasn’t interested in a federal contract — they were aiming to change the developing world with quick, inexpensive injection devices that could save millions of lives.

But at the conference, Walker found himself at a table with Giroir at a luncheon, just two seats apart. The admiral was fascinated by the low-cost injection technology, Walker said, and when Walker showed him the prototype that he always carries in his pocket, Giroir asked how they plan to do this in the U.S.

Walker said he told the admiral that the company wasn’t planning to operate in the U.S. but was struck by Giroir’s enthusiasm.

“He was the first person, if not the only person at the event, who understood the revolutionary nature of this platform,” Walker recalled in an interview with AP. “And he said, ‘Wow this is amazing. You need to do this in the U.S.’”

Walker continued to resist, he said, but Giroir — who is also a doctor specializing in pediatric critical care — “wasn’t big on taking no for an answer,” Walker said.

At Giroir’s urging they presented the prototype injector to U.S. officials. HHS declined to make agency officials available for interviews.

It wasn’t until later, when Walker was introduced by a friend to Col. Matthew Hepburn at the Defense Advanced Research Projects Agency, that a plan for ApiJect to work in the United States began to take shape, he said.

HHS Assistant Secretary for Preparedness and Response Robert Kadlec approved a $10 million contract for ApiJect for research and development in January 2020, according to a document in the federal procurement data system. The company was responsible for securing private investments to create new production lines where the devices would be made over three to five years.

When the pandemic emerged weeks later, officials sounded the alarm about a potential shortage of needles and syringes to deliver a vaccine if and when one became available.

The federal Strategic National Stockpile of medical supplies had only 15 million syringes, according to Rick Bright, who later left his position at Health and Human Services and filed a whistleblower complaint.

Bright warned White House trade adviser Peter Navarro and his HHS colleagues of a looming needle shortfall, according to a series of emails disclosed in his complaint.

“We are hearing rumblings about the US inventory of needles and syringes … heading to other countries,” wrote Bright. “There is limited inventory in the supply chain, it could take 2+ years to make enough to satisfy the U.S. vaccine needs.”

Navarro said the U.S. would need 850 million needles.

“We may find ourselves in a situation where we have enough vaccine but no way to deliver all of it,” he said in a February memo to the White House coronavirus task force.

He recommended the task force “direct HHS BARDA to initiate a program to identify all alternate vaccine delivery methods and ramp up production.“ BARDA is the Biomedical Advanced Research and Development Authority within HHS.

Suddenly ApiJect’s 5-year plan to mass produce its devices became a sprint measured in months with a new $138 million contract, announced in May, to produce 100 million devices by year’s end.

Jefferies Financial Group is acting as the leader of the public-private partnership with HHS and invested $10 million to help ApiJect build surge production facilities in March. The company said it would try to raise up to $1 billion more. There have been no additional announcements of funding.

Walker said due to nondisclosure agreements with both the government and investors, the company is unable to say what private funding they’ve secured so far.

OPERATION WARP SPEED

On a warm mid-May day in the White House Rose Garden, President Donald Trump introduced “a massive scientific, industrial and logistical endeavor” dubbed Operation Warp Speed.

The idea, he said, was to be ready to distribute a COVID-19 vaccine as soon as it was developed.

“We must not be caught short on our capacity to deliver emergency drugs to Americans in need,” said HHS Secretary Alex Azar.

An estimated 700 million injections may be needed to inoculate the nation -- at least two shots for every person, according to the military document.

In early May, the government put in two orders, to Retractable Technologies in Little Elm, Texas, and Marathon Medical in Aurora, Colorado, totaling 320 million needles and syringes.

Later in May, the government announced plans for ApiJect to manufacture more than 500 million all-in-one devices that would come pre-loaded with the vaccine.

On Wednesday, the largest domestic manufacturer of needles and syringes, Becton Dickinson, announced the first U.S. order of $11.7 million for 50 million needles and syringes by the end of this year. It plans to ramp up manufacturing over the next year.

And earlier this month Retractable entered into a second contract with the government, this one for $53 million meant to boost domestic manufacturing.

Together that sounds like enough injection devices.

But Retractable, which was worried enough about its financial future that earlier this year it received a $1.36 million loan from the Paycheck Protection Program, has been doing about 80% of its manufacturing in China. And Marathon is a medical supply distributor, and there is no indication on its web site that it manufactures needles and syringes at all. The company did not respond to repeated requests for comment.

Despite the race to replenish the domestic needle and syringe supply, about 400 shipping containers of syringes have left the U.S. for countries including Germany, Colombia, Australia, Brazil and Italy this year, according to Panjiva Inc., a service that independently tracks global trade. That’s the same, on average, as syringe exports over the past five years.

Experts acknowledge that a mass vaccination campaign is going to be complicated.

“There are a lot of moving parts to this,” said Dr. Bruce Gellin, the Sabin Vaccine Institute’s president of global immunization.

Darin Zehrung, who studied medical devices at PATH, a nonprofit advocating for health equity, said it’s wise to invest in new injection technologies. But that only works if there are plenty of basic syringes and needles stocked up.

“Hedging bets is the best approach, but plan for the worst case scenario and hope for the best case scenario,” said Zehrung.

AWAITING APPROVAL

ApiJect’s devices are self-contained, with soft plastic blisters that are squeezed, like a nose spray or eye drop, to push the vaccine through an attached needle and into the patient.

The device includes a little computer chip — like the ones in credit cards — that can transmit information about the drug, dose, location and time of administration. The chip is not injected into patients.

Other injection devices Koska designed have been used in the developing world, but this ApiJect technology has not.

The company said they have started discussions with the U.S. Food and Drug Administration to review the device on a priority basis while the company moves ahead fitting factories to make their injectors. The agency wouldn’t confirm this, citing its policy against discussing products involved in clinical trials.

Testing different vaccine candidates in the ApiJect devices will be critical before injecting the public.

Plastic could interact differently with the liquid than the glass vials currently used in trials, experts say. And there are strict temperature requirements. ApiJect’s planned process is to pour vaccine doses into the warm plastic blisters as they come off the production line, the company says. ApiJect says they can instantly cool the devices as they are made.

Walker, the ApiJect CEO, who founded the online travel agency Priceline, acknowledges that the government’s decision to rely on “an emergency plan of refitting established pharmaceutical manufacturing facilities is risky. But we feel good about it.”

NO COMMENT

The Associated Press asked the Health and Human Services department over many weeks to explain the government’s approach. The agency didn’t allow an official to speak on the record for this story.

A senior administration official, speaking on condition of anonymity because the agency declined to allow him to identified by name, told AP he wasn’t familiar with ApiJect or the contract. But he said the government was buying a range of devices to deliver the vaccine because they don’t know what they need. And, he said, the Trump administration is looking to boost domestic manufacturing.

When AP reached out directly to Trump’s vaccine czar, Moncef Slaoui, to discuss the new technology, a spokesperson said the query was inappropriate.

“If this continues, we will make no one else available either,” Natalie Baldassarre, a special assistant at HHS, wrote in an email.

Last week, HHS Assistant Secretary of Public Affairs Michael Caputo wrote that the agency has “lost interest in assisting your story” and offered no further comment.

___

Mendoza reported from San Francisco. Linderman reported from Baltimore. Lauran Neergaard and Stephen Braun in Washington contributed.

___

Contact AP’s Investigative Team at investigative@ap.org.
Dengue Fever prevention efforts stifled by coronavirus pandemic


By VICTORIA MILKO and ANIRUDDHA GHOSAL

People move away as health workers fumigate a slum to prevent an outbreak of dengue fever in Jakarta, Indonesia, on Monday, March 23, 2020. While 2019 was the worst year on record for global dengue cases, experts fear an even bigger surge is possible because their efforts to combat it were hampered by restrictions imposed in the coronavirus pandemic. (AP Photo/Dita Alangkara)

A worker fumigates a slum to prevent an outbreak of dengue fever in Jakarta, Indonesia, Wednesday, April 22, 2020. While 2019 was the worst year on record for global dengue cases, experts fear an even bigger surge is possible because their efforts to combat it were hampered by restrictions imposed in the coronavirus pandemic. (AP Photo/Dita Alangkara)

JAKARTA, Indonesia (AP) — To slow the spread of the coronavirus, governments issued lockdowns to keep people at home. They curtailed activities that affected services like trash collection. They tried to shield hospitals from a surge of patients.

But the cascading effects of these restrictions also are hampering efforts to cope with seasonal outbreaks of dengue, an incurable, mosquito-borne disease that is also known as “breakbone fever” for its severely painful symptoms.

Southeast Asian countries like Singapore and Indonesia have dealt with concurrent outbreaks of dengue and coronavirus this year. In Brazil, where there are over 1.6 million COVID-19 infections, at least 1.1 million cases of dengue have been reported, with nearly 400 deaths, according to the Pan American Health Organization.

Dengue cases are likely to rise soon with the start of seasonal rains in Latin American countries like Cuba, Chile and Costa Rica, as well as the South Asian countries of India and Pakistan.

A Mumbai Municipal Corp. worker fumigates a street in Mumbai, India, Wednesday, June 10, 2020. While 2019 was the worst year on record for global dengue cases, experts fear an even bigger surge is possible because their efforts to combat it were hampered by restrictions imposed during the coronavirus pandemic. (AP Photo/Rafiq Maqbool)


Dengue typically isn’t fatal, but severe cases may require hospitalization. Prevention efforts targeted at destroying mosquito-breeding sites, like removing trash or old tires and other objects containing standing water, are still the best ways to curb the spread of the disease. But coronavirus-era lockdowns and other restrictions have meant that these efforts have been reduced or stopped altogether in many countries.

In northwestern Pakistan, plans to disinfect tire shops and markets that had dengue outbreaks in 2019 were shelved due to funds being used for the coronavirus, said Dr. Rizwan Kundi, head of the Young Doctor’s Association.

Health workers who would destroy mosquito-breeding sites in India’s capital of New Delhi are also screening people for the virus.

Having to identify thousands of virus cases has meant that dengue surveillance has suffered in many Latin American countries, added Dr. Maria Franca Tallarico, the head of health for the Americas regional office of the International Federation of Red Cross and Red Crescent Societies.

Experts say that disrupting such prevention efforts is ominous for the global battle against dengue.

The World Health Organization says 2019 was the worst year on record for dengue cases, with every region affected, and some countries were hit for the first time.

Aedes aegypti, the mosquito that spreads dengue, is most prevalent in cities, and experts warn that increased urbanization and warming temperatures due to climate change means that its range will keep increasing.

Experts say that while reduced travel means fewer opportunities for mosquitoes to bite people with dengue to become carriers themselves, the coronavirus pandemic has introduced other variables.

Staying home -- one way to slow outbreaks of COVID-19, especially in cities -- poses greater risks for spreading dengue, said Singapore’s National Environment Agency (NEA). That’s because the Aedes mosquito bites during the day, and with more people staying home, where mosquito populations are high, the more likely they are to be bitten.

The impact is already visible. Singapore recorded a five-fold increase in the mosquito larvae detected in homes and common corridors of residential areas during the two-month coronavirus lockdown period, compared with the previous two months. By July 6, the total of dengue cases in Singapore was more than 15,500. The NEA says the number of cases this year is expected to exceed the 22,170 cases reported in 2013, which at the time was the largest dengue outbreak in Singapore’s history.

Oliver Brady, an associate professor at the London School of Hygiene & Tropical Medicine, said Central America and the Caribbean were at higher risk due to overlapping outbreaks.

Working with communities in Latin America to stop mosquitoes from breeding had been the most successful anti-dengue strategy in recent years, Tallarico said. But with strict limitations on movement, she said they didn’t know whether these measures were still happening, and “this is the big concern for us.”

A shortage of protective equipment also means limiting the number of first responders who can check on people with fever or cough, she said.

“My concern is that you have (many) more cases of dengue ... but the capacity of the system to notify (and) test is limited,” she said.

Dengue patients need acute care, and this could lead to a “double whammy” that overwhelms health care systems, said Scott O’Neill, founder and director of the World Mosquito Program.

“The health care system is already crumbling. ... I am not sure how (India’s) existing health care system will be able to handle this load,” said Dr. S.P Kalantri, a public health specialist.

Global research into dengue also will be affected by the coronavirus pandemic, Brady said.

At the WMP Tahija Foundation Research Laboratory in Yogyakarta, Indonesia, which has been studying dengue for years, “it became too difficult to enroll patients with the social-distancing measures,” O’Neill said. The facility is now being used as a COVID-19 testing site.

Similarly, the National Institute of Malaria Research in New Delhi has stopped all field work after it was converted into a center for validating COVID-19 testing kits, said Dr. R.C Dhiman, who studies mosquitoes and climate change.

In Bangladesh, where dengue season is just starting, the launch of a mobile app to help people report their cases was delayed by the pandemic, said Afsana Alamgir Khan, who oversees the country’s dengue program.

Experts say such disruptions by the coronavirus will only increase the risks of dengue infections.

—-

Ghosal reported from New Delhi. Associated Press writers Edna Tarigan in Jakarta, Indonesia, Kathy Gannon in Islamabad and Julhas Alam in Dhaka, Bangladesh, contributed to this report.

—-

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Tear gas used on Portland protesters, 1 man injured

RIGHT WING COPS ASSAULT PEACEFUL PROTESTERS IN CAMPAIGN AGAINST
ANTIFA

PORTLAND, Ore. (AP) — Federal law enforcement officers used tear gas and crowd-control munitions on people protesting near Portland’s federal courthouse during a protest that started Saturday night, Portland police said.

Oregon Public Broadcasting reports that friends and family of a demonstrator say a 26-year-old man was struck in the head and injured by an impact munition fired by authorities.

Desiree LaBella, the mother of Donavan LaBella, said he suffered facial and skull fractures. He came out of surgery early Sunday morning and was responding to doctors.

“He was awake enough to give the OK to talk to me,” she told OPB. “He’s had some facial reconstruction surgery. They’re just watching him right now.”

Video posted to social media showed the man apparently being struck in the head after holding a speaker aloft.

Federal officers at the Mark O. Hatfield U.S. Courthouse asked for help from city police at about 2 a.m. Sunday after protesters resisted arrest and threw bottles, the Portland Police Bureau said. Announcements were made for protesters to leave the area, and the crowd dispersed around 3:20 a.m., police said.

Fires were started in trash cans and dumpsters, but no buildings were threatened, police said. One person was arrested on suspicion of unlawfully pointing a laser.

In a statement, Gov. Kate Brown called for federal officials to scale back their response to the protests, which have roiled Oregon’s largest city for six weeks following the death of George Floyd in Minneapolis.

“The events of last night at the federal courthouse were the tragic and avoidable result of President Donald Trump, for weeks, continuing to push for force and violence in response to protests,” Brown said.

Portland Commissioner Jo Ann Hardesty criticized the federal officers.

“This reckless and aggressive behavior has now put someone in the hospital,” Hardesty said. “This protester is still fighting for their life and I want to be clear: this should never have happened. If this continues a life will be taken and it won’t matter whether a federal officer or Portland Police officer did it -– it won’t bring that person back.”

Last week Portland’s Deputy Police Chief, Chris Davis, said an “agitator corps” of violent protesters are responsible for vandalism and chaos in the city. Davis made a distinction between Black Lives Matter protesters, whom he said were not violent, and a smaller group of people he repeatedly called “agitators.”

On Friday, one person was taken into custody after hitting a federal officer in the head and shoulder with a hammer during a protest at the nearby Edith Green-Wendell Wyatt Federal Building. No details were released about the officer’s injuries. Several other people accused of pointing lasers into the eyes of federal officers were also taken into custody.

Federal officers also used tear gas during that protest.

The Department of Homeland Security has deployed officers in tactical gear from around the country, and from more than a half-dozen federal law enforcement agencies and departments, to Portland as part of a surge aimed at what a senior official said were people taking advantage of demonstrations over the police killing of George Floyd to engage in violence and vandalism.
Judge: Petition to recall Seattle mayor can move forward

SEATTLE (AP) — A King County Superior Court judge has approved a petition for an election to recall Seattle Mayor Jenny Durkan.

The Seattle Times reports the ruling Friday on charges filed by a group of five people last month comes after weeks of local protests against racism and police brutality — sparked by the killing of George Floyd in Minneapolis.

Once any recall petition is approved, signatures are needed to qualify for a special election ballot. The petitioners must, within 180 days, collect valid signatures from a number of voters equal to 25% of the votes cast in the last election. In this case, signatures from more than 50,000 Seattle voters would be needed.

The Durkan petitioners’ recall effort accuses the mayor of “endanger(ing) the peace and safety of the community” by allowing police to “leak false information about fabricated crimes and threats to the media” and issuing a citywide curfew without sufficient notice to the public. The petitioners also accused Durkan of restricting certain property rights in downtown Seattle and Capitol Hill, the neighborhood where many of the protests took place.

In a response Saturday, Durkan’s chief of staff, Stephanie Formas, said the mayor “consistently has acted to protect the City’s public health and safety and to respect the constitutional rights to peaceful protesters.”

In her ruling Friday, Judge Mary E. Roberts dismissed six of the seven charges put forward as “insufficient,” but allowed one — which accuses Durkan of allowing tear gas and other crowd control weapons to be used during the coronavirus pandemic — to proceed “more narrowly than alleged.”

The judge did not rule on whether the allegation was true. “This court’s role in this case is limited,” she wrote.

The mayor could appeal the ruling, but Formas did not say if she would.


Alaska protesters interrupt campaign event with animal heart



ANCHORAGE, Alaska (AP) — Protesters in Alaska carrying a banner and a caribou heart interrupted a campaign event for a U.S. senator seeking reelection.

The small group of protesters were restrained and escorted out by staff and attendees at Republican Sen. Dan Sullivan’s campaign launch event in a hangar near Ted Stevens Anchorage International Airport Saturday, The Anchorage Daily News reports.


Kathleen Bonnar said she approached Sullivan while carrying the caribou heart to the stage in a handbag.

She was accompanied by another woman, later identified as Crystal Berwick.

A video posted online showed Sullivan’s campaign manager, Matt Shuckerow, restraining Bonnar. The animal heart slipped from her hands onto the floor, leaving blood on Shuckerow and the stage.

At least two other women carrying a banner reading “Heartless Sullivan” attempted to rush the stage during the confrontation but were also pulled outside.

Bonnar said the heart fell from her hands when her arms were grabbed, which is why there may have been the misperception she intended to throw it.

“I think things just got really blown way out of proportion. None of us had any intention to be violent at all. We didn’t even expect the response we received at all,” Bonnar said.

Shuckerow said he attempted to stop Bonnar because he was not sure what the object was as she attempted to remove the heart from her bag.

The action was “not a safe protest, it was not peaceful, it was in fact violent on the part of the protesters,” Shuckerow said.

The demonstrators issued a statement afterward saying they were “attempting to establish a dialogue about Sullivan’s record against Alaska Native interests.”

The statement, which said the group consisted of Alaska residents who were not connected to any organization or corporation, said the protest was peaceful and they plan to seek assault charges against those who ejected them.
Chatham announces plan to buy newspaper publisher McClatchy


FILE - Copies of the McClatchy Co. owned Miami Herald newspaper are shown Oct. 14, 2009, in Miami. Hedge fund Chatham Asset Management plans to buy newspaper publisher McClatchy out of bankruptcy, ending 163 years of family control. The companies did not put a price on the deal in an announcement Sunday, July 12, 2020. The agreement still needs the approval of a bankruptcy judge; a hearing is scheduled for July 24. (AP Photo/Wilfredo Lee, File)

NEW YORK (AP) — Hedge fund Chatham Asset Management plans to buy newspaper publisher McClatchy out of bankruptcy, ending 163 years of family control.

The companies did not put a price on the deal in an announcement Sunday. The agreement still needs the approval of a bankruptcy judge; a hearing is scheduled for July 24.

McClatchy is one of the largest newspaper companies in the U.S. It owns 30 papers including the Miami Herald, the Charlotte Observer and the Sacramento Bee. It filed for bankruptcy protection because of a heavy debt load stemming from its $4.5 billion purchase of the Knight-Ridder newspaper chain in 2006, just as the newspaper industry went into steep decline.


Chatham was McClatchy’s largest shareholder and debt holder. It beat out a bid from Alden Global Capital, another hedge fund that has taken a leading role in the U.S. newspaper business.

Chatham’s other media holdings include the Canadian newspaper chain Postmedia and National Enquirer publisher American Media Inc. But industry expert Ken Doctor has noted that it doesn’t make financial sense to combine those with McClatchy in order to cut costs, as newspaper dealmakers like to do. And the emergence of Alden Global Capital as a bidder has given rise to speculation that Chatham will try to combine McClatchy with Alden’s holdings or with another big newspaper company, like Gannett.

While national newspapers such as The Wall Street Journal and The New York Times are adding digital subscribers that help them navigate advertising declines, many local outlets have had a difficult time. That has contributed to a string of bankruptcies and consolidation, much of it involving investment firms, deepening concerns about declining quality as newsrooms shrink and papers close.

The coronavirus pandemic has exacerbated ad-revenue declines and prompted furloughs, pay cuts, layoffs and more newspaper closings.

Several mayors of cities where McClatchy has a paper wrote to the bankruptcy court, asking the judge to consider the civic value of the paper.

“We want our newspaper to emerge from this bankruptcy with owners who are willing to invest in our community, and provide us with journalism at its best,” Lexington, Kentucky, mayor Linda Gorton said of the Lexington Herald-Leader.

McClatchy’s origins date to 1857, when it began publishing a four-page paper in Sacramento, California, following the California Gold Rush. The company remains headquartered in Sacramento.