Trump-touted hydroxychloroquine shows no benefit in COVID-19 prevention: study

(Reuters) – A malaria drug taken by U.S. President Donald Trump to prevent COVID-19 did not show any benefit versus placebo in reducing coronavirus infection among healthcare workers, according to clinical trial results published on Wednesday.

The study largely confirms results from a clinical trial in June that showed hydroxychloroquine was ineffective in preventing infection among people exposed to the new coronavirus.

Trump began backing hydroxychloroquine early in the pandemic and told reporters in May he started taking the drug after two White House staffers tested positive for COVID-19. Studies have found the drug to offer little benefit as a treatment.

In the study of 125 participants, four who had taken hydroxychloroquine as a preventative treatment for eight weeks contracted COVID-19, and four on placebo tested positive for the virus.

All eight were either asymptomatic or had mild symptoms that did not require hospitalization, according to the results published in the JAMA Internal Medicine journal.

The research shows that routine use of the drug cannot be recommended among healthcare workers to prevent COVID-19, researchers from the University of Pennsylvania said.

The study authors said it was possible that a trial conducted in a community with higher prevalence of the disease could allow detection of a greater benefit from the drug.

In the latest trial, which was terminated before it could reach its enrollment target of 200 participants, mild side effects such as diarrhea were more common in participants taking the malaria drug compared to placebo.

(Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli)

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Brisbane doctor John Robert Ullman, 52, accused of supplying drugs to bikies

A Brisbane doctor accused of supplying and trafficking drugs to outlaw motorcycle gang members has been suspended from practising medicine by the Health Ombudsman.

Chermside skin cancer doctor John Robert Ullman, 52, was arrested and slapped with more than 160 charges last week relating to allegations he supplied testosterone, diazepam and other drugs to at least 39 different people over a two-year period.

As part of his bail application, Ullman’s lawyer Tyronne Thomas argued the doctor should be released because he was the only GP rostered on to work during the school holidays at the skin cancer clinic.

“He also within the next couple of weeks he also has patients that require skin cancer treatment,” Mr Thomas told the court on Wednesday last week.

“I’m instructed he’s the only general practitioner working at the clinic over the school holidays.”

Doctor John Robert Ullman leaves the police watch house in Brisbane. Picture: NCA NewsWire / Dan Peled
media_cameraDoctor John Robert Ullman leaves the police watch house in Brisbane. Picture: NCA NewsWire / Dan Peled

But the Health Ombudsman has announced it has taken “immediate action” against Ullman, suspending his medical registration as of Friday last week.

“In accordance with (the Health Ombudsman Act), the Health Ombudsman’s decision will continue to have effect until the Queensland Civil and Administrative Tribunal sets the decision aside or the Health Ombudsman revokes the suspension of (Ullman’s) registration…,” the ombudsman said.

Ullman’s profile was also removed from the website of the skin cancer clinic within 24 hours of his arrest despite him being granted bail.

Magistrate Michael Quinn said at the time he was satisfied the prosecution had a “strong case” but granted the bail on strict conditions including that Ullman provide a $50,000 surety.

Under the bail conditions he is also required to reside at his Chelmer home with his family, surrender his passport, report to Indooroopilly police each Monday and Friday and have no contact with the people he is accused of supplying drugs to.

Police prosecutor Senior Constable Hayley Kipps had objected to Ullman being granted bail, alleging he was a risk of further reoffending if released from custody.

“Of serious concern is that some of the alleged supplies relate to outlaw motorcycle club gang members,” Snr Const Kipps told the court.

She said allegations Ullman had supplied drugs to 39 people were of “serious concern” and there was a “high probability” he would commit offences if released on bail.

“It is the prosecution submission that an actual period of custody is within range so there is not a risk of (Ullman) serving too much time (if not granted bail),” she said.

Ullman will face court again on November 16.

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Trump, pressured over pandemic, says states will receive 150 million tests

By Steve Holland and Andrea Shalal

WASHINGTON (Reuters) – President Donald Trump, under fire over his handling of the coronavirus epidemic, announced on Monday the federal government would ship 150 million rapid tests to U.S. states and warned an increase in positive cases is likely in the days ahead.

Trump, at a Rose Garden event, said the tests would largely be used for opening schools and ensuring safety at centers for senior citizens. He has been pressuring state governors to do more to open schools for in-person learning.

Trump, Vice President Mike Pence and virus adviser Scott Atlas warned more positive cases may result from stepped up testing.

“With cases and positivity rising in 10 states in the Midwest and the near-West, and with this historic advance in testing that’s being distributed … the American people should anticipate that cases will rise in the days ahead,” Pence said.

The president has repeatedly suggested that more testing leads to more cases, when in fact testing uncovers cases that already exist. Other metrics like increased hospitalizations and deaths have no link to more testing.

The United States has the world’s highest number of confirmed COVID-19 cases at more than 7 million and the most coronavirus-related deaths, approaching 205,000.

Coronavirus task force members Dr. Anthony Fauci, Dr. Deborah Birx and Centers for Disease Control and Prevention (CDC) Director Robert Redfield were not at the event.

Two weeks ago Trump was irked when Redfield said in congressional testimony that wearing a mask may be just as important as a vaccine.

Trump said 50 million tests will go to the “most vulnerable communities” including nursing homes, assisted living facilities, home health and hospice care. Nearly 1 million will be sent to historically Black colleges and universities and tribal nation colleges.

He said 100 million tests would be given to states and territories to “support efforts to reopen their economies and schools immediately and (as) fast as they can.”

“The support my administration is providing would allow every state on a very regular basis test every teacher who needs it,” Trump said.

He said 6.5 million tests will go out this week and the rest in coming weeks.

Trump is trying to show progress in the battle against the pandemic as he campaigns for re-election on Nov. 3 against Democrat Joe Biden. The first presidential debate will be held on Tuesday night in Cleveland, Ohio.

The rapid tests announced by Trump were purchased from Abbott Laboratories <ABT.N> in August.

Abbott has said it would scale production capacity to 50 million tests per month by October, and that it could currently produce “tens of millions” of the tests, indicating it will take at least a few months for the tests to be fully distributed to states and territories.

Admiral Brett Giroir, who heads testing efforts for Trump’s coronavirus task force, demonstrated at the event how to conduct the Abbott rapid test, swabbing his nasal passages and dipping the swab into a solution. Results are produced

California Fitness Chain Explores Options to Ease Debt After Virus Shuts Gyms

(Bloomberg) — In-Shape Health Clubs is exploring strategic options including a debt restructuring, raising capital or a potential sale as the Covid-19 pandemic continues to wreak havoc on gym operators, according to people with knowledge of the matter.



A person disinfects dumbbells at a gym.


© Bloomberg
A person disinfects dumbbells at a gym.

The California fitness chain, which laid off the majority of its employees in March, is working with an adviser as it considers alternatives after the coronavirus caused it to shut more than 60 locations, said one of the people. They asked not to be identified because the talks are private.

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The company, which has been reopening some of its fitness centers, has been owned since 2013 by Fremont Private Holdings, an arm of the San Francisco-based private investment office for the Bechtel family, and Pulse Equity Partners LLC.

Representatives for In-Shape and Pulse declined to comment, while a Fremont representative didn’t immediately respond to a request for comment.

Starved of revenue amid government restrictions intended to fight the pandemic, U.S. fitness chains have fallen into distress. Several have filed for bankruptcy, including 24 Hour Fitness Worldwide, Gold’s Gym International and Town Sports International LLC, the owner of the New York Sports Clubs and Lucille Roberts.

Debt Pile

In-Shape has about $70 million in debt, split across a $17 million revolving credit facility and a $53 million first-lien term loan, according to data compiled by Bloomberg.

The company traces its roots to 1981, when a single racquetball club in Stockton, California, was turned into a full-service health club. Before the pandemic, the chain had grown to more than 60 clubs in California, offering swimming, tennis, basketball and other activities, according to the company’s website.

Earlier this month, the California Fitness Alliance — which In-Shape is part of — said it filed legal action in Los Angeles County Superior Court seeking to restore “reasonable” access to indoor fitness, citing benefits to physical and mental health.

“We created strict guidelines to ensure public safety when exercising indoors, so Californians could receive the health benefits associated with exercise and help expand the fight against Covid-19,” Francesca Schuler, Chief Executive Officer of In-Shape Health Clubs, said at the time. “When the state briefly reopened, these protocols worked.”

Schuler cited a CFA study showing that of the more than 5.5 million members who checked into 785 fitness centers between June 12 and July 13, only 0.002% tested positive for the virus, with no cases reported as a result from visits to fitness centers.

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Boston Coronavirus Cases Surge, City Added To 23 ‘High Risk’ Zones

KEY POINTS

  • Boston and 10 other Massachusetts cities have been listed as coronavirus red zones
  • State health officials reported more than 8 cases per 100,000 residents over the past 14 days
  • 23 municipalities in Massachusetts are considered “high risk” for COVID-19 infection

Boston and 10 other Massachusetts cities have been listed as red zones or “high risk” areas as of Wednesday night as a sudden spike in the number of cases bring the state’s total to 128,753.

According to Boston News, health officials from the Department of Public Health reported more than eight cases per 100,000 residents over the past two weeks. They also confirmed 32 new COVID-19 casualties, which brings Massachusetts’ death toll up to 9,242. 

In all, 23 municipalities in the state are considered “high risk” for coronavirus infection. The new communities joining Boston on the list are Attleboro, Avon, Dracut, Haverhill, Lowell, Lynnfield, Methuen, Middleton, North Andover, and Springfield. 

Health officials also moved three communities—Saugus, Tyngsborough, and Wrentham—to moderate risk as their infection rates continue to experience a drop. 

Before the release of the report, Boston Mayor Marty Walsh said the city was not moving into the second step of its three-phase reopening plan due to the surge of coronavirus cases. 

“We expect to be in the red zone very soon, and it is likely to happen this evening. That means we’ve been seeing more than eight new cases per day per 100,000 people population,” Walsh said Wednesday.

During a press conference, Walsh noted that half of the new cases reported in the city involved people aged 29 and younger. He also said the city would maintain its coronavirus restrictions to curb the virus’s spread, WBUR reported.

Food courts may continue to operate, and movie theaters may go to a 50% capacity and limit their audience to 250 people. Gatherings will be limited to 25 people for indoor events and 50 for outdoor affairs. 

According to WCVB, public school students in Boston will begin returning to classrooms Thursday, depending on their grade level and academic needs. The highest-need students will be the first to transition using a hybrid model. 

Pre-schoolers and kindergartners would be required to report to school in the second week of October, while first- and third-graders would follow the week of Oct. 22.

Under the hybrid model, students are to learn in-person for two days a week and switch back to remote-learning the other three days of school. Families are given the option to keep their children remote. 

Madrid has seen a surge in coronavirus cases in Spain's second wave Madrid has seen a surge in coronavirus cases in Spain’s second wave Photo: AFP / OSCAR DEL POZO

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New Jersey Veterans Homes Likely Failed to Acknowledge Covid-19 as Cause in Dozens of Deaths, Officials Say

A state-run nursing home for veterans in New Jersey failed to attribute nearly 40% of its likely Covid-19 deaths to the virus, according to the state’s own Department of Health.

The Menlo Park Veterans Memorial Home, in Edison, N.J., attributed 62 deaths to the new coronavirus on the website of the state’s veterans’ affairs agency. But a Department of Health spokeswoman, Nancy Kearney, said late Wednesday that an additional 39 people probably died from the virus at the facility during a wave of infections there.

Another state-run veterans home, in Paramus, N.J., also likely had more Covid-19 deaths than the total it attributed to the virus, Ms. Kearney said. The likely undercount at the two facilities, among the deadliest in the state for the virus, was first reported by The Wall Street Journal.

The findings show how publicly reported nursing home mortality figures can fail to reflect the true toll the pandemic has taken on the facilities, which are home to some of the most virus-vulnerable people in the country.

A spokesman for the New Jersey Department of Military and Veterans Affairs, Kryn Westhoven, in a statement released Wednesday, said his agency “mourns each and every veteran that passes away in our Memorial homes…. Much like other long-term care facilities across the state and country, Covid-19 created unprecedented circumstances and demands within our veterans memorial homes. During this time, all deaths were reported to the Department of Health.”

The New Jersey Veterans Home at Paramus, another state-run home for former members of the U.S. military, originally reported 81 Covid-19 deaths.



Photo:

timothy a. clary/Agence France-Presse/Getty Images

The two state-run nursing homes have faced a barrage of criticism from families of deceased residents. The Paramus facility, which initially reported more deaths, has in particular come under fire.

In the early days of the pandemic, testing wasn’t widely available to residents at many facilities. A large number of deaths at Menlo in April, the peak of that facility’s outbreak, were attributed to other causes, such as pneumonia, even as the death toll soared above usual levels.

The Paramus facility reported 81 deaths linked to Covid-19. The health department’s Ms. Kearney said an additional eight patients at that facility probably died from the virus.

The state counted as probable deaths those that weren’t clearly explained by another cause where patients had Covid-19 symptoms, or autopsies found signs of Covid-19, Ms. Kearney said in an email, as well as some other types of deaths.

Veterans agency records viewed by the Journal show nearly 100 people died at the Menlo facility in April alone. That’s about as many as the facility typically loses in a year, historical records show.

Mr. Westhoven also said in an earlier interview that the department only counted deaths when a death certificate expressly listed Covid-19 as the cause. That accounting missed some cases where residents tested positive but still didn’t have Covid-19 listed on their death certificates.

William Hefele, a Navy veteran and Menlo resident, was hospitalized in early April

Trump’s attack on Hunter Biden underscores ‘harmful stigma’ of addiction

Remarks like these perpetuate “a harmful stigma,” said Mark Sutton, spokesman for the nonprofit Drug Policy Alliance, which advocates for the decriminalization of drug use.

“At a time when we have approximately 70,000 people in the United States dying per year from accidental overdose, it is unconscionable that someone vying for our highest elected office would be so willing to throw people struggling with substance-use disorder under the bus,” he added.

Federal data shows that roughly 1 in 10 American adults — or 23 million people — have struggled with a drug-use disorder at some point in their lives. Such a diagnosis is “based on a list of symptoms including craving, withdrawal, lack of control, and negative effects on personal and professional responsibilities,” according to the National Institutes of Health. Drug abuse is not necessarily illicit — many people addicted to opioids obtain them legally through a doctor’s prescription, for instance.

Drug and alcohol abuse often inflict suffering on the affected person’s family members. “By the time most families reach out for help and drug treatment, the disease of addiction has typically progressed to a crisis stage for the addict and family alike,” according to the Hazelden Betty Ford Foundation. The number of Americans with firsthand experience with addiction and dependency is probably much larger than official statistics show.

Drug and alcohol abuse are devastating disorders. Drug overdoses killed approximately 72,000 people in 2019, while excessive drinking is “responsible for more than 95,000 deaths in the United States each year, or 261 deaths per day,” according to the CDC, a figure that includes deaths from chronic alcohol-related illnesses, suicides, alcohol poisoning and drunken-driving crashes.

But according to many experts, the stigma surrounding drug and alcohol abuse is even more deadly.

“I think the biggest killer out there is stigma,” U.S. Surgeon General Jerome Adams said in 2019. “Stigma keeps people in the shadows. Stigma keeps people from coming forward and asking for help. Stigma keeps families from admitting that there is a problem.”

Writing this year in the New England Journal of Medicine, the director of the National Institute on Drug Abuse, Nora Volkow, said that stigmatizing people who use drugs “may be the equivalent of an electric shock in the cycle of drug addiction: it’s a powerful social penalty that spurs further drug taking … respect and compassion are essential.”

Hunter Biden has been open about his substance abuse, chronicling his history of alcohol and drug use — as well as his attempts to get those behaviors under control — for Adam Entous of the New Yorker in 2019. The Biden campaign did not respond to a request for comment.

For many people with a drug or alcohol problem, the support of family members is critical. At the debate, Biden’s response to Trump illustrated what that support looks like.

“My son, like a lot of people, like a lot of people you know at home, had a drug problem,” Biden said. “He’s overtaken it. He’s fixed it. He’s worked

Moderna Coronavirus Vaccine Won’t Be Ready For Distribution Until Spring 2021

KEY POINTS

  • Moderna’s candidate vaccine may not be ready for widespread distribution until next spring
  • The company CEO said they could get an approval by the early second quarter of 2021
  • Trump has repeatedly claimed a vaccine will be available to the general population in weeks

Biotech company and coronavirus vaccine frontrunner Moderna announced Tuesday that its vaccine candidate would not be ready for widespread distribution until next spring. 

In an interview with the Financial Times, Moderna CEO Stephane Bancel said the company is unlikely to seek emergency authorization from the U.S. Food and Drug Administration for frontline workers and at-risk individuals until Nov. 25, at the earliest. 

Bancel also spoke at a health conference on Wednesday, saying the drugmaker would not seek approval for use in the general population until late January 2021. If the vaccine is proven to be safe and effective, its approval could take until early April 2021. 

“I think a late first quarter, early second quarter approval is a reasonable timeline, based on what we know from our vaccine,” Bancel said.

The timeline is a setback for the pharmaceutical company that announced earlier this month that it could seek authorization for its vaccine candidate as early as Nov. 1. It also deals a blow to President Donald Trump, whose administration has already purchased 100 million doses of the company’s experimental coronavirus vaccine at $15 per dose. 

During the first presidential debate on Tuesday, Trump claimed that a vaccine will be available for widespread distribution in December, despite a prediction from Robert Redfield, director of the Centers for Disease Control and Prevention, that it is unlikely a vaccine will be available until the second or third quarter of next year, CBS News reported.

“We’re weeks away from a vaccine,” the president said during Tuesday night’s debate. “I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to — Moderna, Johnson & Johnson and others. They can go faster than that by a lot.”

Seven potential COVID-19 vaccine candidates are now undergoing late-stage testing, including Pfizer. In media appearances, the company’s chief executive Dr. Albert Bourla has repeatedly said that they expect a “conclusive readout” of their vaccine by October. He also said Pfizer is prepared to apply for emergency authorization, as reported by the New York Times. 

“Right now, our model — our best-case — predicts that we will have an answer by the end of October,” Bourla said. 

A US biotech firm Moderna has reported 'positive interim' results in early testing of a vaccine candidate A US biotech firm Moderna has reported ‘positive interim’ results in early testing of a vaccine candidate Photo: AFP / Thibault Savary

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Pandemic AVR: Making Patients Wait May Do More Harm Than Good

Recent cardiac events suffered by patients with symptomatic severe aortic stenosis (AS) could be tied to whether their hospitals expedited aortic valve replacement (AVR) in select cases or paused these procedures in response to COVID-19, two reports suggested.

In the first, a Swiss hospital showed success selecting patients for expedited AVR despite safety concerns during the pandemic, whereas a New York City center that pushed these procedures back for everyone had a substantial number of patients subsequently die or require urgent transcatheter AVR (TAVR) while waiting, the second found.

Both reports were published online in JAMA Network Open.

“Taken together, these studies provide useful guidance. First, as we have known for many years, symptomatic AS is a life-threatening condition, and its treatment cannot be considered elective in any way. Patients with the most echocardiographically severe stenosis, clinically advanced symptoms, or comorbid coronary artery disease or lung disease belong at the head of the line,” according to Thoralf Sundt, MD, of Massachusetts General Hospital and Harvard Medical School in Boston.

“Whether one chooses to interpret the current state of the pandemic as an ongoing first wave — perhaps with a nadir in some regions — or as the quiet before a second wave, there is a clear need for tools permitting precise triage of patients by the urgency with which procedures should be performed,” he emphasized in an accompanying editorial.

Selective AVR in Switzerland

Certain people with critical AS were good candidates for expedited AVR during a nationwide ban on elective procedures, according to the prospective AS DEFER study.

A cohort of 71 patients referred for AVR from March 20 to April 26, a period when Switzerland banned elective procedures in all hospitals, were divided into two treatment groups according to a prespecified algorithm:

  • Expedited (n=25): Patients with critical AS (i.e., aortic valve area ≤0.6 cm2, transvalvular mean gradient ≥60 mm Hg, cardiac decompensation during the previous 3 months, or exercise intolerance with clinical symptoms on minimal exertion) who underwent TAVR at a mean 10 days after referral
  • Deferred (n=46): Patients with a larger aortic valve area and stable symptoms

Adverse cardiac outcomes were not statistically more likely for either group at an average 31 days after treatment allocation: the composite endpoint of all-cause mortality, disabling and nondisabling stroke, and unplanned hospitalization for valve-related symptoms or worsening heart failure reached 4.0% of the expedited group versus 19.6% of those deferred (log rank P=0.08), reported Thomas Pilgrim, MD, MSc, of Inselspital, Bern University Hospital, and colleagues.

Hospitalizations were more likely in the deferred AVR arm than the expedited arm (19.6% vs 0.%, P=0.02) and accounted for all the primary outcome events in the former. No patient died.

Among deferred AVR patients, those who wound up requiring hospitalization for valve-related symptoms or worsening heart failure had more commonly presented with multivalvular disease (44.4% vs 8.6%, P=0.02), suggesting that this group in particular may benefit from expedited AVR, Pilgrim’s group said.

“I cannot tell if the authors considered

West Orange-Cove schools to require virtual learning students with failing grades, too many absences to return to campus

The West Orange-Cove Consolidated Independent School District amended its virtual learning policy, and the changes may force dozens of students to return to campus. 

West Orange-Cove CCISD changes virtual learning criteria

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It’s a move that isn’t sitting well with some parents as they weigh the dangers of face to face learning during a pandemic. 

The policy has sparked outrage among some students and parents of WOCCISD, and many feel like they’re having to choose between health and an education. 

Virtual learning has become a way of life during the pandemic. The prospect of it not being available concerns parent Ryan Melancon. 

“This decision doesn’t just affect money, it doesn’t just affect kids’ education, it affects the lives of parents and the grandparents these students will come and contact with,” Melancon said. 

RELATED: State health department takes down COVID-19 school tracker after reports of errors

He has two children in WOCCISD. The district recently announced that students who aren’t passing and who have more than 5 absences can no longer participate in virtual learning. 

A district spokesperson said a number of students simply aren’t showing up and aren’t completing coursework, which led to the change in policy. 

Rayne Keith, Melancon’s daughter, said her biggest concern is potentially bringing the virus home. 

“My dad could die and I just don’t want that to happen so I take it very seriously and there are a bunch of parents that their parents could die from COVID and the school just doesn’t seem to care,” Keith said. 

She feels that the school should handle things differently. 

“The school has made a situation that they could have managed a lot worse,” Keith said.

WOCCISD will allow a few exceptions. Some of those who are passing classes, have health conditions, or have been exposed to the virus will be exempt. Melancon said it’s not enough, and is willing to do whatever it takes to protect his kids. 

“If I have to pull them from the district I will. They will not be going back. It’s not a matter of if, it’s a matter of when they will catch COVID at these schools,” Melancon said. 

Students who meet the criteria that the district has set are expected to return to campus on Monday, October 5. For anyone with concerns about the policy, you’re encouraged to contact the district. 

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