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
May 8,2020

Washington, May 8: Four top Republican senators have urged US President Donald Trump to suspend all-new guest worker visas for 60 days and some of its categories, including the H-1B visa, for at least the next year or until unemployment figures return to normal levels in the country.

The unemployment figures in the US have reached an all-time high due to the coronavirus pandemic. The letter has been signed by Senators Ted Cruz, Tom Cotton, Chuck Grassley and Josh Hawley.

"As you know, more than 33 million Americans have filed for unemployment coverage just since mid-March, and approximately one-fifth of the American workforce is currently out of work. This is a stunning difference compared with the historically-low nationwide unemployment rate of just 3.5 per cent in February this year," they said in their letter to the president on Thursday.

The letter, dated May 7, specifically calls for suspension of all non-immigrant guest worker visas for the next 60 days, followed by a continued suspension of certain categories of new non-immigrant guest worker visas for a year or until the national unemployment figures return to normal levels.

"To protect unemployed Americans in the early stages of economic recovery, we urge you to suspend all non-immigrant guest worker visas for the next 60 days," the senators said.

Exceptions to this suspension should be rare, limited to time-sensitive industries such as agriculture and issued only on a case-by-case basis, when the employers can demonstrate that they have been unable to find Americans to take the jobs, the senators wrote.

After 60 days, the senators urged Trump to continue to suspend new non-immigrant guest workers for a year or until the national unemployment figures return to normal levels, whichever comes first.

"That suspension should, at a minimum, include H-2B visas (non-agricultural seasonal workers), H-1B visas (specialty occupation workers) and the Optional Practical Training (OPT) program (extension of foreign student visas after graduation). We also urge you to suspend the EB-5 immigrant visa program, effective immediately," the lawmakers wrote.

The H-1B work visa for foreign technology professionals is highly popular among Indians and a large number of Indians also opt for the EB-5 investors visa.

The senators argued that there is no reason why unemployed Americans and recent college graduates should have to compete in such a limited job market against an influx of additional H-1B workers, most of whom work in business, technology or STEM fields.

"Temporarily suspending the issuance of new H-1B visas would also protect the hundreds of thousands of H-1B workers and their families already working in the United States -- workers who could otherwise be subject to deportation if they are laid off for more than 60 days," they said.

"Of course, appropriate exceptions could also be crafted to the H-1B program suspension to allow for doctors, nurses and other healthcare professionals who wish to come to the United States to assist in combating the coronavirus pandemic," the senators wrote.

Additionally, the United States ought to suspend its Optional Practical Training (OPT) programme, which allows foreign students in the country to extend their stay after graduation for one to three years to get "experience in the field" by taking jobs here, they wrote.

In 2019, more than 223,000 former foreign students had their OPT applications approved or extended. While the merits of such a programme are subject to debate, there is certainly no reason to allow foreign students to stay for three additional years just to take jobs that would otherwise go to unemployed Americans as the country's economy recovers, the lawmakers said.

The senators also urged Trump to remove the EB-5 visa from the exemptions in his Presidential Proclamation issued on April 22, at least until real reforms are adopted.

The EB-5 programme has long been plagued by scandal and fraud, and criticised as effectively functioning as a pay-for-citizenship scheme in many cases. There is no reason that the programme should receive preferential treatment as opposed to other green card programmes for employment-based immigrants, the lawmakers said.

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Agencies
February 25,2020

Washington, Feb 25: Democratic presidential front-runner Senator Bernie Sanders on Monday slammed President Donald Trump for selling weapons to India, saying that the US should instead partner with New Delhi to fight climate change to save the planet.

Sanders, who has won the Nevada and New Hampshire primaries and tied in Iowa, made the comments after Trump, who is on a two-day visit to India, on Monday announced that the US will sign defence trade deals worth USD 3 billion with India.

In an address at a massive "Namaste Trump" rally at Motera stadium in Ahmedabad, Trump announced that deals to sell state-of-the-art military helicopters and other equipment worth over USD 3 billion will be sealed with India on Tuesday.

“Instead of selling USD 3 billion in weapons to enrich Raytheon, Boeing and Lockheed, the United States should be partnering with India to fight climate change,” Sanders said in a tweet, the first by a Democratic presidential candidate on Trump's India visit.

“We can work together to cut air pollution, create good renewable energy jobs, and save our planet,” he said.

However, a former White House official defended the US' decision to sell arms and weapons to India.

“I'm proud of my service in the White House, in which we poured enormous energy into deepening climate and green tech cooperation w/ India... and also advancing security cooperation and defense sales. I'd like to think both can be part of a strong, values-based partnership,” Joshua White said.

According to the US State Department, India plays a vital role in the US vision for a free and open Indo-Pacific.

In 2016, the US designated India as a Major Defence Partner. Commensurate with this designation, India in 2018 was granted Strategic Trade Authorization tier 1 status, which allows New Delhi to receive license-free access to a wide range of military and dual-use technologies that are regulated by the Department of Commerce.

Bilateral defence trade with India in a little over a decade has increased from near zero in 2008 to USD20 billion.

Among some of the key foreign military sales notified to Congress include MH-60R Seahawk helicopters (USD2.6 billion), Apache helicopters (USD2.3 billion), P-8I maritime patrol aircraft (USD3 billion), and M777 howitzers (USD737 million).

India was the first non-treaty partner to be offered a Missile Technology Control Regime Category-1 Unmanned Aerial System – the Sea Guardian UAS manufactured by General Atomics.

The State Department is also advocating for the Lockheed Martin F-21 and Boeing F/A-18 – two state of the art fighter aircraft that India is currently evaluating.

These platforms provide critical opportunities to enhance India's military capabilities and protect shared security interests in the Indo-Pacific region, it argued.

The top categories of DCS to India include aircraft, electronics and gas turbine engines.

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Agencies
April 14,2020

The US Commission on International Religious Freedom (USCIRF) has reprimanded the Imran Khan government for denying food aid to Hindus and Christians in Pakistan amid the coronavirus pandemic and warned that it will trigger an additional crisis due to religious discrimination.

The USCIRF is an independent federal government entity set up by the US Congress to monitor and report on religious freedom in the world.

Pakistan continues to be in the tier one of the USCIRF list of the countries whose record on religious freedom remains abysmal.

In a statement issue on Monday, the USCIRF said it was troubled by the reports of food aid being denied to Hindus and Christians in Pakistan amid pandemic.

Citing one of the examples of religious discrimination, the USCIRF said that in Karachi, the Saylani Welfare International Trust, a non-government organization set up to help the homeless and seasonal workers, has been refusing food aid to Hindus and Christians and providing it only Muslims.

Describing such actions "reprehensible", the USCIRF commissioner Anurima Bhargava said: "As COVID-19 continues to spread, vulnerable communities within Pakistan are fighting hunger and to keep their families safe and healthy. Food aid must not be denied because of one's faith."
One of the USCIRF commissioners, Johnnie Moore warned that if the Khan government continued with such policies, Pakistan would add an additional crisis.

"In a recent address by Prime Minister Khan to the international community, he highlighted that the challenge facing governments in the developing world is to save people from dying of hunger while also trying to halt the spread of COVID-19. This is a monumental task laying before many countries.

"Prime Minister Khan's government has the opportunity to lead the way but they must not leave religious minorities behind. Otherwise, they may add on top of it all one more crisis, created by religious discrimination and inter-communal strife."

The organization which makes foreign policy recommendations to the US President, the Secretary of State, and Congress, urged the Pakistani government to ensure that food aid from distributing organizations is shared equally with Hindus, Christians, and other religions minorities.

Last year, in its annual report, the USCIRF had noted that Hindus and Christians in Pakistan "face continued threats to their security and are subjected to various forms of harassment and social exclusion".

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