Hydroxychloroquine, a drug promoted by Trump, failed to prevent healthy people from getting covid-19 in trial – The Washington Post

June 3rd, 2020

“As we say in Tennessee, ‘that dog won’t hunt’ — it didn’t work,” said William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center. Schaffner, who was not involved in the trial, praised it as “rigorously done.”

The results were the latest development in a highly charged medical and political issue — the efficacy of hydroxychloroquine in combating covid-19. Trump has repeatedly touted the drug as a “game changer” for covid-19 and recently said he took it for several days. But federal regulators have said it should be used only for hospitalized patients or in clinical trials, because of possible side effects including serious heart-rhythm issues.

Researchers launched the trial in mid-March. They enrolled more than 800 adults in the United States and Canada who were exposed to someone with covid-19 because of their jobs as health-care workers or first responders, or because they lived with someone with the disease. The study was a randomized, placebo-controlled trial and was double-blinded, meaning neither the participants nor the researchers knew what the participants received. Such a study is considered the gold standard for clinical trials.

Adding to the controversy surrounding the drug, a large observational study on hydroxychloroquine that warned of dangerous side effects has come under fire in recent days. The study, published May 22 by the Lancet medical journal, was based on records from hundreds of hospitals and involved 96,000 hospitalized coronavirus patients on six continents. It found that those who received hydroxychloroquine or a closely related drug, chloroquine, had a significantly higher risk of death than those who did not. Shortly after its publication, the World Health Organization suspended the use of hydroxychloroquine in a large international trial testing therapies for the disease and France banned it as a treatment for covid-19.

In recent days, scientists have raised questions about the validity of the data used for the study. On Tuesday, the Lancet published an “expression of concern” about the study. The researchers said in a statement that they are conducting an independent review of the data, which came from an outside company. Among other things, critics are skeptical that so many health records could have been collected in such a short period of time and have cited inconsistencies about dosing information. In addition, the company has not explained its methodology, scientists say. The WHO, meanwhile, resumed its trial of hydroxychloroquine, saying its safety experts concluded there was no reason to discontinue it.

The prevention trial released Wednesday showed 40 percent of the participants who took the drug developed side effects that were not serious — mostly nausea, upset stomach and diarrhea. The study found no serious side effects or cardiac complications, the researchers said.

Its findings reinforced those of previous studies showing the drug does not provide benefit against covid-19.

“It’s not surprising given that there has not been efficacy established for this drug in any meaningful way,” said Eric Topol, director of the Scripps Research Translational Institute in San Diego. “It’s not a large study, but it extends the spectrum from the most severely ill patients to mildly ill and now preventive.”

Jeanne Marrazzo, an infectious-disease expert at the University of Alabama at Birmingham, said the results “should provide a very big nail in the coffin” for the idea that hydroxychloroquine can help prevent covid-19.

David Boulware, an infectious-disease specialist at the University of Minnesota and the study’s senior investigator, said he launched the trial because hydroxychloroquine had shown signs in a lab setting that it might be effective against the virus.

About two-thirds of the trial participants were health-care workers and the rest were a mix of other people exposed to someone with covid-19, he said. They were given hydroxychloroquine or a placebo for five days and then followed for two weeks to see who developed the disease.

The participants were recruited on the Internet through social media. Their eligibility was confirmed with documents, and the team sent medications overnight via FedEx. Given the political sensitivities of the issue, Boulware said, it was important the participants did not know who was getting the drug and who was getting the placebo.

“So if some were for Trump and some were not Trump supporters, all that would be washed out because the trial was blinded,” he said.

Overall, about 12 percent given the drug developed covid-19, while 14 percent given the placebo also did — not a statistical difference. There was no benefit for people who also took zinc or vitamin C, the researchers said.

Boulware said that the analysis tried to drill down on whether any subgroups, by race, occupation, age, or co-morbidities, had any hint of benefit. But they could not find any, he said.

One weakness of the trial, he added, is that because testing was not widely available during the time of the trial, their analysis used a combination of lab-confirmed positive covid-19 tests and symptoms to count someone as infected.

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Antidepressant Zoloft and generic version in short supply, FDA says – NBC News

June 3rd, 2020

A spike in demand for anxiety and depression drugs has led to shortages of some forms of the commonly used antidepressant Zoloft and its generic, sertraline.

Reports of the shortage, posted Friday on the Food and Drug Administration’s website, come as a new survey published Wednesday from the Johns Hopkins University shows a major increase in the feelings of distress and despair among adults in the United States.

Full coverage of the coronavirus outbreak

Not all manufacturers are reporting widespread shortages of the drug. Pfizer, which makes Zoloft, has been able to fill existing, ongoing prescriptions, but said it cannot make up for increasing demands of new prescriptions. Some lots of its 50 milligram and 100 milligram dosages are in “limited supply,” according to the FDA.

May 27, 202004:27

The same shortages were reported among companies that make sertraline. Accord Healthcare, Inc. said it’s unable to obtain the active ingredient for the drug “due to the impacts caused by COVID-19.” The company estimated the shortage will last 60 days.

Drugmaker Lupin also cited a shortage of the active ingredient, as well as an increase in demand for the product, which is expected to be on backorder for several months.

The shortages follow a 21 percent rise in the number of prescriptions filled per week between mid-February and mid-March for medicines to treat anxiety, depression and insomnia, according to Express Scripts, a prescription benefit plan provider. The company said the increase peaked the week of March 15, just after the World Health Organization declared COVID-19 a pandemic.

“I haven’t talked to a single patient who isn’t anxious,” said Dr. Philip Muskin, a professor of psychiatry at Columbia University Irving Medical Center in New York City. He also said he’s noted a recent uptick in patients asking for medications to help them sleep.

“It’s not surprising we’re seeing shortages. I think that’s gonna continue for a while.”

Also Wednesday, a survey published in the Journal of the American Medical Association found the percentage of U.S. adults who say they’re feeling anxious, sad, depressed or uncertain has more than tripled in the past two years.

The survey, which included responses from 1,468 adults, found 13.6 percent reported psychological distress in April 2020, up from 3.9 percent surveyed in 2018.

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The increase was most notable among Hispanics, adults under age 30 and people in low-income households.

“Young adults in particular surprised me a bit,” said Beth McGinty, lead author of the new report and associate professor in the department of health policy and management at the Johns Hopkins Bloomberg School of Public Health.

“We’ve been talking so much about how worried we are about older adults who may be isolated. But actually, it’s young adults who seem to be having the most issues,” she said.

The survey did not ask participants why they had these feelings of despair, but McGinty said it likely reflects the pandemic’s impact on education and job opportunities for younger adults just starting out in their careers.

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iPhone looters find devices disabled, with a warning they’re being tracked – Ars Technica

June 3rd, 2020

Paradox Interactive to sign collective bargaining agreement with 200 union members – Polygon

June 3rd, 2020

Coronavirus cases rise in US south and west as crowded protests spark worries – CNN

June 3rd, 2020

(CNN) Coronavirus cases continued to spread in parts of the American south and west in the past week as experts warn that packed protests could exacerbate the pandemic.

The early parts of the American coronavirus outbreak struck hardest in the dense metropolitan areas on the coasts, such as New York, New Jersey, Boston, and California. But the last few weeks have seen wider spread in inland states, including Arkansas, Texas and Arizona.

In Arkansas on Tuesday, Gov. Asa Hutchinson said there were 375 new positive coronavirus tests, the highest single-day number of new community cases. There are currently more people hospitalized with Covid-19 there than at any prior point.

“We continue to trend upward in the number of cases,” Hutchinson said.

Arizona added 1,127 new positive Covid-19 cases on Tuesday, the state’s highest single-day total in the pandemic. Texas, too, has seen over 1,000 new positive coronairus cases in six out of the last seven days.

In total, the US has over 1.8 million cases and over 106,000 deaths, both by far the most of any country in the world.

The map shows each state’s change between the 7-day average of new cases in the past week v. the previous week.

In addition, health officials have expressed concern about a renewed outbreak stemming from the nationwide protests against the police killing of George Floyd.

CNN chief medical correspondent Dr. Sanjay Gupta said that the coronavirus could spread at protests depending on factors like mask-wearing, how closely people gathered, and how long people stayed in close contact.

“i think it’s fair to say that there is going to be an impact,” Gupta said Wednesday.

“It is a contagious virus. People being outside, people wearing masks, people moving by each other more quickly may reduce the likelihood of significant exponential growth. But that’s still the concern.”

For example, Oklahoma State football player Amen Ogbongbemiga said in a tweet on Tuesday that he tested positive for Covid-19 after attending a protest.

“After attending a protest in Tulsa AND being well protective of myself, I have tested positive for COVID-19,” Ogbongbemiga tweeted. “Please, if you are going to protest, take care of yourself and stay safe.”

The virus has particularly impacted African-Americans, who make up a disproportionate percentage of Covid-19 cases and deaths.

Worldwide, Covid-19 cases are increasing most rapidly in parts of Latin America. Brazil now has the second-most cases of any country in the world, and Peru, Chile and Mexico all among the top 15 countries with the most cases, according to data compiled by Johns Hopkins University.

What will stop the virus — and what won’t

Entering the sixth month of the virus, public health officials are more clearly seeing what stops the virus from spreading and what doesn’t.

For one, the textbook combination of identification, isolation and quarantine for contacts helped stop the potential spread of coronavirus an Air Force basic training camp. Military doctors said their approach kept the case count to just five among 10,000 recruits at Joint Base San Antonio-Lackland in Texas in March and April.

The base used techniques including quarantine, social distancing, early trainee screening, rapid isolation and monitored re-entry to slow the transmission, the researchers said in a report published by the US Centers for Disease Control and Prevention Tuesday.

“Beginning March 17, all new recruits were segregated upon arrival for a two-week arrival quarantine on an area of the base separated from the main cohort of trainees,” Dr. Joseph Marcus of the Brooke Army Medical Center and colleagues wrote in their report. “In addition, all trainees were instructed to maintain a distance of at least 6 feet between one another to ensure social distancing.”

In April, the use of face coverings was made mandatory. The strategies put into place at the base meant that the rate of infection was significantly lower than that of other communal living environments, such as homeless shelters.

On the other hand, warmer weather is unlikely to stop the spread of coronavirus, Dr. Francis Collins, the director of the National Institutes of Health, said in a blog post Tuesday.

“Climate only would become an important seasonal factor in controlling COVID-19 once a large proportion of people within a given community are immune or resistant to infection,” Collins wrote, citing experts in infectious disease transmission and climate modeling.

“We’ll obviously have to wait a few months to get the data. But for now, many researchers have their doubts that the COVID-19 pandemic will enter a needed summertime lull,” he added.

Collins is just the latest expert to throw cold water on the theory, boosted by President Donald Trump, that speculated heat would lessen the spread and possibly kill the virus altogether.

Dr. Fauci optimistic about vaccine

The US should have 100 million doses of one candidate Covid-19 vaccine by the end of the year, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID) and a member of the White House coronavirus task force, said Tuesday.

“Then, by the beginning of 2021, we hope to have a couple hundred million doses,” Fauci said during a live question and answer session with the Journal of the American Medical Association.

It’s still not clear whether the vaccine will be effective against the novel coronavirus. Still, Fauci expressed optimism that one of the many vaccine trials would be successful.

“I’m cautiously optimistic that with the multiple candidates we have with different platforms, that we are going to have a vaccine that will make it deployable,” Fauci said.

CNN’s Jen Christensen, Naomi Thomas and Shelby Lin Erdman conributed to this report.

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Apple’s 2021 iPad Pros could have 5G – The Verge

June 3rd, 2020

From Citizen to Signal, the most popular apps reflect America’s protests – Vox.com

June 3rd, 2020

Fauci predicts U.S. should have “couple of hundred million doses” of coronavirus vaccine by new year – CBS News

June 3rd, 2020

Washington — Dr. Anthony Fauci, one of the nation’s leading infectious disease experts, believes that by early 2021, the U.S. will have “a couple of hundred million doses” of a vaccine for the coronavirus.

In an interview with the Journal of the American Medical Association on Tuesday, Fauci said there are four or five trials underway for vaccine candidates, and he expects the U.S. to have millions of doses of a vaccine by the end of the year.

“By the beginning of 2021, we hope to have a couple of hundred million doses,” he said.

The Trump administration launched Operation Warp Speed several weeks ago with the goal of speeding up the development and distribution of a coronavirus vaccine. While public health experts, including Fauci, have said it takes 12 to 18 months to develop a vaccine, President Trump and Health and Human Services Secretary Alex Azar are aiming to have 300 million doses of a vaccine available to the American people by the new year.

Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force, said Phase III trials for a vaccine candidate developed by Moderna, a U.S.-based biotech company, are expected to begin in early July. The trial will involve 30,000 people and include a wide spectrum of participants, including the elderly and those with underlying conditions and comorbidities. 

Another vaccine candidate from AstraZeneca, developed by the University of Oxford, is proceeding on a similar track, Fauci said.

“I’m cautiously optimistic that with the multiple candidates that we have with different platforms, that we’re going to have a vaccine that shows a degree of efficacy that would make it deployable,” he said, adding that most who become infected with the coronavirus recover and make an immune response to clear the virus.

“If the body is capable of making an immune response to clear the virus of natural infection, that’s a pretty good proof of concept to say that you’re going to make an immune response in response to a vaccine,” he said.

But Fauci cautioned there is “never a guarantee, ever, that you’re going to get an effective vaccine.”

Fauci said production of a vaccine is going to proceed as trials are underway, speeding up the time it takes to get it to the public.

“It isn’t as if we’re going to make the vaccine, show it’s effective and then have to wait a year to rev up to millions and millions and millions of doses,” he said. “That’s going to be done as we’re testing the vaccine.”

As many states begin to slowly ease restrictions put in place to mitigate the spread of the coronavirus, public health officials say a return to normalcy will hinge on the widespread availability of a vaccine.

The Trump administration last month announced a partnership with AstraZeneca for at least 300 million doses of the vaccine developed by Oxford and committed up to $1.2 billion to the effort.

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Why are outbreaks of infectious diseases on the rise? | COVID-19 SPECIAL – DW News

June 3rd, 2020

COVID-19 is an unprecedented global health crisis in many ways. But the emergence of the
disease is also part of an alarming pattern. Scientists say the number of new infectious diseases in humans like SARS, MERS and
COVID-19 has risen dramatically over the last decades.A study showed that the number of emerging infectious diseases in humans almost
quadrupled between 1940 and 2000. And it’s not just that there are more types of disease. The total number of outbreaks is rising
too. In fact, the total number of outbreaks of all diseases, both old and new, has roughly
tripled since 1980. So what is causing the rise of new infectious diseases in our world today? And how do
humans contribute?

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CES will be held in-person in Las Vegas next year – The Verge

June 3rd, 2020