Malaria drug Hydroxychloroquine fails to prevent COVID-19 in a rigorous study

News Network
June 4, 2020

Jun 4: A malaria drug President Donald Trump took to try to prevent COVID-19 proved ineffective for that in the first large, high-quality study to test it in people in close contact with someone with the disease.

Results published Wednesday by the New England Journal of Medicine show that hydroxychloroquine was no better than placebo pills at preventing illness from the coronavirus.

The drug did not seem to cause serious harm, though -- about 40% on it had side effects, mostly mild stomach problems.

 “We were disappointed. We would have liked for this to work,” said the study leader, Dr. David Boulware, an infectious disease specialist at the University of Minnesota.

“But our objective was to answer the question and to conduct a high-quality study,” because the evidence on the drug so far has been inconclusive, he said.

Hydroxychloroquine and a similar drug, chloroquine, have been the subject of much debate since Trump started promoting them in March.

Hydroxychloroquine has long been used for malaria, lupus, and rheumatoid arthritis, but no large studies have shown it or chloroquine to be safe or effective for much sicker patients with coronavirus, and some studies have suggested the drugs may do harm.

Trump took a two-week course of hydroxychloroquine, along with zinc and Vitamin D, after two staffers tested positive for COVID-19, and had no ill effects, according to results of his latest physical released by his doctor Wednesday.

Federal regulators have warned against hydroxychloroquine's use except in hospitals and formal studies because of the risk of side effects, especially heart rhythm problems.

Boulware's study involved 821 people in the United States and Canada living with someone diagnosed with COVID-19 or at high risk of getting it because of their job -- doctors, nurses, ambulance workers who had significant exposure to a sick patient while not wearing full protective gear.

They were randomly assigned to get either the nutrient folate as a placebo or hydroxychloroquine for five days, starting within four days of their exposure. Neither they nor others involved in the research knew who was getting which pills.

After 14 days in the study, 12 per cent on the drug developed COVID-19 symptoms versus 14 per cent in the placebo group, but the difference is so small it could have occurred by chance, Boulware said.

“There's basically no effect. It does not prevent infection,” he said of the drug. Even if it were to give some slim advantage, “we'd want a much larger effect” to justify its use and risk of side effects for preventing illness, he said.

Results were no different among a subgroup of participants who were taking zinc or vitamin C, which some people believe might help make hydroxychloroquine more effective or fight the coronavirus.

There are some big caveats: The study enrolled people through the Internet and social media, relying on them to report their own symptoms rather than having them tracked in a formal way by doctors.

Participants were not all tested for the coronavirus but were diagnosed as COVID-19 cases based on symptoms in many cases. And not all took their medicines as directed.

The results “are more provocative than definitive,” and the drug may yet have prevention benefits if tried sooner or in a different way, Dr. Myron Cohen of the University of North Carolina at Chapel Hill wrote in a commentary in the journal.

Others were glad to see a study that had a comparison group and good scientific methods after so many weaker reports on hydroxychloroquine.

“This fits with everything else we've seen so far which suggests that it's not beneficial," said Dr. Peter Bach, director of a health policy center at Memorial Sloan Kettering Cancer Center in New York.

This study was in younger relatively healthy people, but the results “would make me very discouraged about trying to use this in older people” who are most vulnerable to serious illness from the coronavirus, Bach said.

“If it does work, it doesn't work very well.” Dr. Dan Culver, a lung specialist at the Cleveland Clinic, said there's still a chance that giving the drug sooner than four days after someone's exposure to the virus may help prevent illness.

But the study “takes 'home run' off the table” as far as hopes for the drug, he said.

The study was mostly funded by David Baszucki, founder of Roblox, a California-based game software company, and other private donors and the Minnesota university.

Boulware also is leading a study testing hydroxychloroquine for treating COVID-19. The study is finished and results are being analyzed now.

On Tuesday, the journal Lancet posted an “expression of concern” about a study it published earlier this month of nearly 15,000 COVID-19 patients on the malaria drugs that tied their use to a higher risk of dying in the hospital or developing a heartbeat problem.

Scientists have raised serious questions about the database used for that study, and its authors have launched an independent audit.

That work had a big impact: the World Health Organization suspended use of hydroxychloroquine in a study it is leading, and French officials stopped the drug's use in hospitals. On Wednesday, the WHO said experts who reviewed safety information decided that its study could resume.

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News Network
February 4,2020

Feb 4: Americans on Monday kicked off the first vote of the 2020 presidential race as the midwestern state of Iowa began its caucuses, the closely-watched first step in deciding which Democrat will face incumbent Donald Trump in November's election.

The two frontrunners, left-wing Senator Bernie Sanders and former Vice President Joe Biden face a key test in the sparsely populated state, with a handful of others looking to make their mark to give their campaigns momentum.

The Iowa vote is a critical early look at the viability of the 11 Democratic candidates still in the race - even though just 41 Iowa delegates are up for grabs, a fraction of the 1,991 needed to secure the party nomination in July.

Iowa Democrats filed into nearly 1,700 caucus sites - schools, libraries, churches, mosques and meeting halls with Sanders and Biden in the lead in the state, followed by former South Bend, Indiana mayor Pete Buttigieg and Senator Elizabeth Warren, who is also on the left of the party.

But polling has fluctuated and Iowa's quirky caucus system - where voting is not by secret ballot but by public declaration for a candidate - makes the night hard to predict.

Luke Elzinga, a volunteer for Sanders, appeared early at Lincoln High School in Des Moines which was converted into a caucus location.

"I think he really inspires a lot of young people, a lot of disaffected voters who might not otherwise turn out," Elzinga, 28, told AFP news agency shortly before the caucusing began.

"And so I think he's the best candidate to beat Trump."

Three candidates - Sanders, Warren and Amy Klobuchar - have faced the unprecedented scenario of spending much of the past two weeks tethered to Washington for the impeachment trial of Trump instead of on the campaign trail in Iowa.

Even as candidates sought to make 11th-hour impressions on undecided voters, the senators were obligated to return to Washington for the trial's closing arguments on Monday.

Defeating Trump

In a vote scheduled for Wednesday, Trump is almost certain to be acquitted by the Republican-led upper house on charges of abuse of power and obstruction of Congress.

For Democrats, second-tier hopefuls Klobuchar and tech entrepreneur Andrew Yang look to outpace expectations and seize momentum heading into the next contest in New Hampshire on February 11.

Earlier on Monday Biden - who still holds the lead in national polls - brought pizza to a field office in a strip mall near Des Moines to thank volunteers.

"I'm feeling good about today," he said.

Like many candidates, Biden spent the weekend crisscrossing Iowa in a final push to convince undecided voters he is best placed to accomplish Democrats' number one goal: defeating Trump.

The president has not stood idly by. On Sunday he branded Biden "Sleepy Joe" and described Sanders as "a communist," previewing a likely line of attack were Sanders to win the nomination.

Unlike secret ballot voting, caucus-goers publicly declare their presidential choice by standing together with other supporters of a candidate.

Candidates who reach 15 percent support earn delegates for the nomination race while supporters of candidates who fall short can shift their allegiance to others.

Turnout is critical, and candidates and their representatives will seek to persuade voters on issues including healthcare, taxes and ending Washington corruption.

One key candidate who has opted not to contest in Iowa is billionaire businessman Michael Bloomberg, who entered the race in November but has surged into fourth place in RealClearPolitics' national polling average.

The former New York mayor, who has spent more than $300m on advertising, according to Advertising Analytics, is focused on running a national campaign with particular emphasis on states that vote on "Super Tuesday," on March 3.

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News Network
June 20,2020

Sao Paulo, June 20: Brazil’s government confirmed on Friday that the country has risen above 1 million confirmed coronavirus cases, second only to the United States.

The country’s health ministry said that the total now stood at 10,32,913, up more than 50,000 from Thursday. The ministry said the sharp increase was due to corrections of previous days’ underreported numbers.

Brazilian President Jair Bolsonaro still downplays the risks of the virus after nearly 50,000 deaths from COVID-19 in three months, saying the impact of social isolation measures on the economy could be worse than the disease itself.

Specialists believe the actual number of cases in Brazil could be up to seven times higher than the official statistic. Johns Hopkins University says Brazil is performing an average of 14 tests per 1,00,000 people each day, and health experts say that number is up to 20 times less than needed to track the virus.

Official data show a downward trend of the virus in Brazil’s north, including the hard-hit region of the Amazon, a plateau in cases and deaths in the countries’ biggest cities near the Atlantic coast, but a rising curve in the south.

In the Brazilian countryside, which is much less prepared to handle a crisis, the pandemic is clearly growing. Many smaller cities have weaker health care systems and basic sanitation that’s insufficient to prevent contagion.

“There is a lot of regional inequality in our public health system and a shortage of professionals in the interior,” said Miguel Lago, executive director of Brazil’s Institute for Health Policy Studies, which advises public health officials.

That creates many health care deserts, with people going long distances to get attention. When they leave the hospital, the virus can go with them.

The cattle-producing state of Mato Grosso was barely touched by the virus when it hit the nation’s biggest cities in March. Sitting far from the coast, between the Bolivian border and Brazil’s capital of Brasilia, its 33 lakh residents led a mostly normal life until May. But now its people live under lockdown and meat producers have dozens of infected workers.

In Tangará da Serra, a city of 1,03,000 people in Mato Grosso, the mayor decided Friday to forbid the sale of alcoholic drinks for two weeks as an incentive for people to stay home.

Fᢩo Junqueira said the measure was needed after a spike in COVID-19 cases that filled 80% of the city’s 54 intensive care beds. The city has had nearly 300 cases of the disease, plus three fatalities.

In Rondonópolis, only 300 miles away from Tangará da Serra and home to a thriving economy, health authorities closed the local meatpacking industry after 92 cases were confirmed there. The city of 1,44,000 inhabitants counted 21 deaths from the virus and more than 600 cases. The mayor has also decided to limit sales of alcoholic beverages.

Even regions once considered examples of successful efforts against the virus are now struggling.

Porto Alegre, home to about 14 lakh people, had success in slowing the virus’ spread over the last three months. But now its mayor is considering increasing social isolation measures after ICU occupancy in the city jumped to 80% this month.

We were already making projections for schools to come back, Mayor Nelson Marchezan Jr. told The Associated Press. Now the trend is to impose more restrictions. Outside Sao Paulo city, five regions of the state’s countryside will have to close shops starting Monday due to a rise in coronavirus cases. Governor João Doria announced the decision Friday.

Dr. Mike Ryan, the World Health Organization’s executive director, said at a news conference that Brazil needs to increase its efforts to stop the spread of infections.

“The epidemic is still quite severe in Brazil. I believe health workers are working extremely hard and under pressure to be able to deal with the number of cases that they see on a daily basis,” Dr. Ryan said.

“Certainly the rise is not as exponential as it was previously, so there are some signs that the situation is stabilising. But we’ve seen this before in other epidemics in other countries.”

Margareth Dalcolmo, a clinical researcher and professor of respiratory medicine at the state-funded Oswaldo Cruz Foundation in Rio de Janeiro, believes the reopening in major cities and the virus traveling by road into Brazil’s heartland will keep the pressure on the country’s health system.

“The risk in the interior now is very big,” she said. “Our health system just can’t solve the most serious cases of COVID in many places of the countryside.”

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News Network
April 10,2020

Paris, Apr 10: French pharma major Sanofi said on Friday it has decided to donate 100 million doses of hydroxychloroquine, the anti-malaria drug which could be a potential weapon against novel coronavirus, across 50 countries.

The company has already doubled its incremental production capacity on top of the usual production for current indications across its eight hydroxychloroquine manufacturing sites worldwide and is on track to quadruple it by the summer.

"In this global health emergency, Sanofi stands ready to assist as many countries as possible, starting with countries where its medicine is registered for current approved indications as well as countries where there are no hydroxychloroquine suppliers or countries with underserved populations," it said in a statement.

Sanofi called for coordination among the entire hydroxychloroquine chain worldwide to ensure the continued supply of the medicine if proven to be a well-tolerated and effective treatment in COVID-19 patients.

"The COVID-19 pandemic is an unprecedented health and economic crisis which is shaking some of the very fundamentals of international solidarity and cooperation among countries," said Chief Executive Officer Paul Hudson. "This virus does not care about the concept of borders, so we should not either," he added.

"It is critical that international authorities, local governments, manufacturers and all other players involved in the hydroxychloroquine chain work together in a coordinated manner to ensure all patients who may benefit from this potential treatment can access it. If the trials prove positive, we hope our donation will play a critical role for patients," said Hudson.

While hydroxychloroquine is generating a lot of hope for patients around the world, said Sanofi, it should be remembered that there are no results from ongoing studies and the results may be positive or negative.

To date, there is insufficient clinical evidence to draw any conclusion over the safety and efficacy of hydroxychloroquine in the management of COVID-19 patients.

It is one of several medicines being investigated by the World Health Organisation (WHO) in its international clinical trial seeking a treatment solution for COVID-19. "Sanofi is supporting ongoing trials by providing the medicine to some participating investigator sites and other independent research centres," it said.

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