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Monday, August 1, 2022

NYC Health Dept. doc who called out PC monkeypox response hits COVID handling too

 The city Health Department “whistleblower” reassigned after he called out as political correctness run amok the agency’s tepid response to the monkeypox outbreak says it also mishandled the COVID-19 pandemic.

Dr. Don Weiss, the veteran surveillance director who was shifted to another unit unrelated to his expertise after disagreeing with department brass over monkeypox messaging, said “too often public health policy has cared more about optics than data” — particularly citing what he deemed as onerous and unnecessary COVID-19 testing requirements for kids in schools.

“Take school testing for COVID-19. It didn’t take long to show that few kids were testing positive and that transmission in schools was not a major contributor to the pandemic,” Weiss said in an extraordinary “leadership” letter posted on his personal website.

“Yet we still continued to force it upon children and families,” he said.

Weiss also said the city’s contact tracing program was an expensive $1 billion plus bust.

“Several of us in the bureau said contact tracing wasn’t likely to work and the pandemic flu plan didn’t include this activity,” he said.

Health Department “whistleblower” Dr. Don Weiss claimed the city mishandled the COVID-19 pandemic.
Health Department “whistleblower” Dr. Don Weiss claimed the city mishandled the COVID-19 pandemic.
Stephen Yang

“And did any of our testing and contact tracing have much of an effect? All you need to do is look at the waves, particularly the Omicron wave.  We had no shortage of testing and a fully staffed contact tracing operation, and we still had a peak of > 60,000 cases per day,” said Weiss.

He said officials were “using teaspoons.(expensive ones) to bail out a gash like the one that sunk the Titanic.”

“Test and Trace shut down this spring and there has been no contact tracing for the current BA.5 wave. Last I heard the cost of the program was in excess of $1 billion dollars,” Weiss said.

He said that the pandemic took a heavy toll on the staff at the city Department of Health and Mental Hygiene, who worked around the clock in a stressful, politically-charged environment.

Weiss claimed the agency has a 30 percent staff vacancy rate as a result after “good people have left in droves.”

Weiss called out the COVID-19 testing requirements for children in city schools.
Weiss called out the COVID-19 testing requirements for children in city schools.
AP Photo/Mark Lennihan, File

But Weiss also claimed weak leadership had contributed to the exodus.

“Leadership support is more than platitudes, and certainly more than gifting a bottle of foul-smelling hand sanitizer on people’s desks. People don’t mind working hard or the extra hours if they know their leader has their back and will stand up to bullying and denigration from politicians,” he said.

He said he worked under seven health commissioners and praised five as having strong public health experience — Neil Cohen under Mayor Rudy Giuliani; Tom Frieden and Tom Farley under Mayor Mike Bloomberg; Mary Bassett, now the state health commissioner; and Oxiris Barbot, under Mayor Bill de Blasio.

“I may not have agreed with every decision prior commissioners have made, but I knew each was made with deliberation and learned consultation,” said Weiss. 

Weiss claimed the city's contact tracing program was ineffective.
Weiss claimed the city’s contact tracing program was ineffective.
REUTERS/Brendan McDermid/File Photo

He notably left the two recent commissioners, David Chokshi, a de Blasio appointee, and current boss Ashwin Vasan, Mayor Eric Adams’ selection, off the list.

“Dr. Farley was a gentleman, Dr. Bassett was elegant and always asked after my family, this one treats us like we are his servants,” he said of Vasan.

Weiss, the former director of surveillance, was transferred to the family and child health unit after publicly criticizing the department’s advice to gay men about reducing the transmission of monkeypox. He said the department was more concerned with “stigma avoidance” instead of making it explicitly clear that gay men should reduce sexual activity to curb viral spread.

He likened his predicament to the Russian imprisoned dissident Alexei Navalny who dared to take on Russian dictator Vladimir Putin.

Weiss claimed that Health Commissioner Dr. Ashwin Vasan treats staffers like his "servants."
Weiss claimed that Health Commissioner Dr. Ashwin Vasan treats staffers like his “servants.”
Gregory P. Mango

“There is little chance that I will be reinstated with the Bureau of Communicable Disease. And I believe the department would prefer that I depart quietly. Like Navalny is to Putin, I am perceived as a threat to power. I can see that the emperor isn’t wearing any clothes and I am not afraid to say it. That’s my first amendment right,” Weiss said.

The health department rebutted Weiss’ criticisms, especially regarding testing for COVID-19 in schools and the Test and Trace program.

Last school year, the city’s In-School Surveillance Testing Program administered nearly 2.5 million COVID-19 tests to New York City students and school staff, and the positivity rate remained at about 1% for the year, the department said in a statement.

“School surveillance was critically important – especially as schools opened early on — to be able to be able to compare COVID transmission in schools with the wider community,” said Health Department spokesman Patrick Gallahue.

“Moreover, it gave staff and students access to testing, which may have otherwise been burdensome. Making testing easy and accessible promoted safety and peace-of-mind for school communities.

The department spokesman also noted that the federal government gave New York stimulus funding “to specifically set up testing operations to keep schools safe.”

The agency also defended the Test and Trace program, which has never closed, and has been rebranded the NYC Test and Treat Corps. It reached 1.7 million New Yorkers with COVID-19 and identified 1.8 million close contacts — ultimately connecting with more than 30% of the city’s population.

The program helped deliver 2.3 million meals and 600,000 care packages to those in quarantine or isolation, steering 32,000 New Yorkers to hotel rooms to safely isolate and provide millions of dollars in cash assistance and scheduled thousands of appointments for testing and vaccination, the statement said.

“The regular communication the program’s contact tracers had with New Yorkers who were infected with or exposed to COVID-19 ensured that they could effectively quarantine and isolate, breaking chains of transmission and stopping the spread of the virus,” Gallahue said.

“Contact tracers also ensured New Yorkers infected with or exposed to COVID-19 were referred to the information and resources needed to safely separate and recover and remained informed about the latest COVID-19 guidance.

In addition, Test-and Trace program distributed more than 33 million at-home tests to schools for students to administer at the first sign of infection or exposure.

“These measures ensured schools remained open and the safest place for young people to be,” Gallahue said.

https://nypost.com/2022/08/01/nyc-health-dept-doc-who-called-out-monkeypox-response-slams-covid-handling/

NYC covid-era outdoor dining sheds kill quality of life with rats, drugs, noise: suit

 A group of Big Apple residents have slapped the city with a lawsuit opposing an outdoor street dining program started during the pandemic – claiming it has increased trash, vermin, drug use, graffiti, noise and awful stenches throughout the boroughs.

The lawsuit was filed by 35 people who live in Manhattan, Brooklyn, Queens and the Bronx who are challenging the Temporary Open Restaurant program meant to help eateries and bars stay afloat during the COVID-19 outbreak by allowing them to expand seating outdoors.

But the residents note that other pandemic-era rules, like those involving masks, vaccines and social distancing, have ended as the outbreak has eased, and argued there is no longer justification to continue the TOR program on an emergency basis — especially since the dining sheds have led to the decline of their neighborhoods, according to the Manhattan Supreme Court lawsuit filed late Friday.

“The open restaurant program has transformed what used to be a pleasant city block with a healthy balance of commercial and residential use into a gritty, shanty streetscape fueled by alcohol sales and marked by sanitation and noise violations,” wrote one of the plaintiffs, Douglas Armer, in a court filing.

Armer says the program has harmed his family’s quality of life in their neighborhood around East 20th Street between Broadway and Park Avenue South.The dining sheds have long become an eyesore, many residents argue.

The dining sheds have long become an eyesore, many residents argue.
G.N.Miller/NYPost
The sheds are little more than a breeding ground for vermin, the suit claims.
The sheds are little more than a breeding ground for vermin, the suit claims.
G.N.Miller/NYPost

The sheds “harbor vermin, collect food waste and impede garbage collection” and there is broken glass and standing water in the gutters, according to an affidavit he filed in the case.

In addition to the structures causing crowding on the sidewalks, “the ‘party’ atmosphere created by the mass of intoxicated patrons is intimidating for young children, casual passersby and residents alike,” Armer’s affidavit says.

Angela Bilotti of Williamsburg, Brooklyn, says the sheds have increased rodents, garbage and mosquitoes and a “horrendous” stench sets in after storms leave standing water at the edge of the walls.

The rats have become such a problem that “during evening dog walks you can even hear rats fighting under the shed floors or they run across the sidewalk and street in numbers,” Bilotti wrote in a court filing.

Residents note other pandemic-era rules have ended as the outbreak has eased, and argued there is no longer justification to continue the TOR program.
Residents note other pandemic-era rules have ended as the outbreak has eased, and argued there is no longer justification to continue the TOR program.
G.N.Miller/NYPost
The lawsuit was filed by 35 people who live in Manhattan, Brooklyn, Queens and the Bronx who are challenging the Temporary Open Restaurant program.
The lawsuit was filed by 35 people who live in Manhattan, Brooklyn, Queens and the Bronx who are challenging the Temporary Open Restaurant program.
G.N.Miller/NYPost

“Riding my bike means dodging rat roadkill,” she wrote.

Brooklyn Community Board 4 chair Robert Camacho says in Bushwick, many restaurants are using the sheds for storage instead of outdoor dining.

Kids also use some of these unoccupied structures to drink and get high, and people leave empty bottles and condoms inside, Camacho said.

Accumulated water and garbage by the sheds have caused them to smell “like urine and human feces,” he wrote in his affidavit.

Accumulated water and garbage by the sheds has caused it to smell "like urine and human feces."
Accumulated water and garbage by the sheds has caused them to smell “like urine and human feces.”
Alexi Rosenfeld/Getty Images

Michael Sussman, a lawyer for the residents, said the TOR program was implemented without public input due to the public health emergency declared during COVID.

“We didn’t challenge it because the emergency was still going on,” Sussman told The Post. “But when the emergency ends, you can’t just say there is a still an emergency.”

“That’s a dangerous precedent,” he added. “What else can they do? We will have martial law. You can’t run a city that way.”

This is the second lawsuit that Sussman has brought against the city over the outdoor dining program.

ooklyn Community Board 4 Chair Robert Camacho says in Bushwick, many restaurants are using the sheds for storage instead of outdoor dining.
Brooklyn Community Board 4 chair Robert Camacho says in Bushwick, many restaurants are using the sheds for storage instead of outdoor dining.
Alexi Rosenfeld/Getty Images

Last year, he filed suit on behalf of another group of city residents opposing the outdoor dining program becoming permanent.

That suit is being appealed by the city after the residents successfully argued that officials did not conduct a proper public review process on the impact of continuing the outdoor dining program permanently.

The plan to make the program permanent was halted pending the appeal.

The Post last month reported on New Yorkers being disgusted about the city’s stench, which has reached rancid levels.

Mayor Eric Adams at a press conference Monday responded to the lawsuit saying he supports outdoor dining, while acknowledging that “we need to modify … because some of the outdoor dining locations have become a hazard.”

“They have become places that [are] not suitable,” Adams said. “And I think there’s a way to modify to standardize what the structure should look like and they have to be used.”

Still, “It can’t be used for storage, it can’t be used for all other things,” the mayor said. “But I’m in support of the outdoor dining. And I just I believe it was a lifeline for the restaurant industry.”

The governor’s office didn’t immediately return a request for comment.

https://nypost.com/2022/08/01/nyc-pandemic-era-outdoor-dining-sheds-destroying-quality-of-life-with-rats-drugs-noise-suit/

Belite Bio started at Buy by Wainwright

 

  • HC Wainwright initiated coverage on Belite Bio Inc  with a Buy rating and price target of $58 per ADS.
  • Belite Bio is focused on developing a novel once-daily oral drug for the treatment of Stargardt disease (STGD1)—a rare inherited juvenile-onset form of macular degeneration.
  • The lead drug candidate is LBS-008 (or Tinlarebant).
  • HC Wainwright says that as LBS-008 is administered orally once a day, it could be adopted rapidly by ophthalmologists and patients once the drug obtains regulatory approval, as the intravitreal injection procedure was found unpleasant.
  • "We believe LBS-008 has the potential to be developed as the first and best-in-class oral drug for the treatment of STGD1," the analyst writes.
  • The analyst expects the Phase 2 portion to report 1-year data in 2H22. 
  • Meanwhile, the company has initiated a Phase 3 trial of LBS-008 in adolescent STGD1 in 1H22, slated to enroll approximately 60 patients. Enrollment for Phase 3 trial to complete in mid-2023. 

Variant type and patient sex affect molnupiravir efficacy

 SARS-CoV-2 variants of concern and the biological sex of patients affect the efficacy of molnupiravir, the first orally available drug approved for outpatient use against COVID-19, according to a new study led by researchers in the Center for Translational Antiviral Research in the Institute for Biomedical Sciences at Georgia State University.

SARS-CoV-2, the virus that causes COVID-19, has triggered recurring infection waves worldwide because of the limited longevity of vaccine-induced immunity, hesitancy of various populations to vaccinate and variants of concern (e.g., alpha, beta, gamma, delta and omicron) that are increasingly contagious or aren’t sensitive to vaccines. Omicron has quickly replaced delta as the dominant circulating strain after first appearing in November 2021.

While oral antivirals such as molnupiravir promise to improve disease management, the efficacy and potency of molnupiravir against variants of concern are either questioned or unknown. Though omicron appears to be milder than previous variants, there’s an urgent need for therapeutics to improve disease management because of record-high daily infection rates and elevated hospitalization numbers.

The study published in the journal Nature Communications tested molnupiravir against SARS-CoV-2 variants of concern in cultured cells, human airway epithelium organoids, ferrets and a dwarf hamster model of severe COVID-19-like lung injury. The analysis found molnupiravir equally inhibited variants of concern in cells and organoids, and treatment reduced shedding and prevented transmission in ferrets.

In addition, the capacity of SARS-CoV-2 to cause disease in dwarf hamsters was dependent on the variant of concern and was highest for the delta, gamma and omicron variants. All hamsters treated with molnupiravir survived, showing reduction in lung virus load from one order of magnitude for delta to four orders of magnitude for gamma. The effect of treatment varied in individual hamsters infected with omicron, and viral load reduction was significant in males but not females.

“We established in this manuscript a novel SARS-CoV-2 animal model that gives high viral load of omicron, which is currently the variant of concern. None of the other models have done that,” said Richard Plemper, senior author of the study, director of the Center for Translational Antiviral Research and Distinguished University Professor in the Institute for Biomedical Sciences at Georgia State. “We show that dwarf hamsters provide a robust experimental system to explore degrees of pathogenicity of different SARS-CoV-2 variants of concern. Unexpectedly, molnupiravir efficacy against omicron was variable between individual dwarf hamsters. Biological sex of the animals emerged as a correlate for therapeutic benefit of molnupiravir use against omicron, with treated males faring better overall than females. By contrast, biological sex had no effect on treatment benefit when dwarf hamsters were infected with gamma or delta, which matched human trial data reported for these variants of concern.”

Scientists have lacked an efficacy model that mirrors the acute lung injury of life-threatening COVID-19 and a relevant experimental platform to test the effect of molnupiravir on mitigating lung damage caused by different variants of concern. This discovery could enable researchers to explore the impact of treatment on disease outcome.

“Without controlled clinical data assessing the efficacy of molnupiravir against omicron, it’s unclear to what degree the results in dwarf hamsters extend to human therapy,” Plemper said. “However, our study demonstrates that pharmacological mitigation of severe COVID-19 is complex and attempts to predict drug efficacy based on unchanged ex vivo inhibitory concentrations alone may be premature. The dwarf hamster-based results illuminate that variant of concern-specific differences in treatment effect size may be present in vivo, alerting the need to continuously reassess therapeutic benefit of approved antivirals for individual patient subgroups as SARS-CoV-2 evolves and potential future variants of concern may emerge.”

Co-authors of the study include Carolin M. Lieber (co-first author), Robert M. Cox (co-first author), Julien Sourimant, Josef D. Wolf and Richard K. Plemper of the Center for Translational Antiviral Research in the Institute for Biomedical Sciences at Georgia State; Kate Juergens, Quynh Phung and Alexander L. Greninger of the University of Washington; Manohar T. Saindane, Meghan K. Smith, Zachary M. Sticher, Alexander A. Kalykhalov, Michael G. Natchus and George R. Painter of Emory University; and Kaori Sakamoto of the University of Georgia.

The study is funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

To read the study, visit https://www.nature.com/articles/s41467-022-32045-1.