Malala visits Pak hometown in Swat Valley

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.

Seoul, Jun 24: North Korea on Wednesday said leader Kim Jong Un suspended a planned military retaliation against South Korea, possibly slowing the pressure campaign it has waged against its rival amid stalled nuclear negotiations with the Trump administration.

Last week, the North had declared relations with the South as fully ruptured, destroyed an inter-Korean liaison office in its territory and threatened unspecified military action to censure Seoul for a lack of progress in bilateral cooperation and for activists floating anti-Pyongyang leaflets across the border.

Analysts say North Korea, after weeks deliberately raising tensions, may be pulling away just enough to make room for South Korean concessions.

Pyongyang's official Korean Central News Agency said Kim presided by video conference over a meeting Tuesday of the ruling Workers' Party's Central Military Commission, which decided to postpone plans for military action against the South brought up by the North's military leaders.

KCNA didn't specify why the decision was made. It said other discussions included bolstering the country's "war deterrent".

Yoh Sang-key, spokesman of South Korea's Unification Ministry, said Seoul was "closely reviewing" the North's report but didn't further elaborate.

Yoh also said it was the first report in state media of Kim holding a video conferencing meeting, but he didn't provide a specific answer when asked whether that would have something to do with the coronavirus.

The North says there hasn't been a single COVID-19 case on its territory, but the claim is questioned by outside experts.

Kim Dong-yub, an analyst from Seoul's Institute for Far Eastern Studies, said it's likely that the North is waiting for further action from the South to salvage ties from what it sees as a position of strength, rather than softening its stance on its rival.

"What's clear is that the North said (the military action) was postponed, not cancelled," said Kim, a former South Korean military official who participated in inter-Korean military negotiations.

Other experts say the North would be seeking something major from the South, possibly a commitment to resume operations at a shuttered joint factory park in Kaesong, which was where the liaison office was located, or restart South Korean tours to the North's Diamond Mountain resort.

Those steps are prohibited by the international sanctions against the North over its nuclear weapons programme.

The public face of the North's recent bashing of the South has been Kim Yo Jong, the powerful sister of leader Kim Jong Un, who has been confirmed as his top official on inter-Korean affairs.

Issuing harsh statements through state media, she had said the North's demolishing of the liaison office would be just the first in a series of retaliatory action against the enemy South and that she would leave it to the North's military to come up with the next steps.

The General Staff of the North's military has said it would send troops to the mothballed inter-Korean cooperation sites in Kaesong and Diamond Mountain and restart military drills in frontline areas.

Such steps would nullify a set of deals the Koreas reached during a flurry of diplomacy in 2018 that prohibited them from taking hostile action against each other.

Also condemning the South over North Korean refugees floating anti-Pyongyang leaflets across the border, the North said Monday it printed 12 million of its own propaganda leaflets to be dropped over the South in what would be its largest ever anti-Seoul leafleting campaign.

It wasn't immediately clear whether Kim's decision to hold back military action would affect the country's plans for leafleting. The North's military had said it would open border areas on land and sea and provide protection for civilians involved in the leafleting campaigns.

The North has a history of dialling up pressure against the South when it fails to get what it wants from the United States. The North's recent steps came after months of frustration over Seoul's unwillingness to defy US-led sanctions and restart the inter-Korean economic projects that would breathe life into its broken economy.

Nuclear negotiations between Pyongyang and Washington largely stalled after Kim's second summit with President Donald Trump last year in Vietnam, where the Americans rejected North Korea's demands for major sanctions relief in exchange for a partial surrender of its nuclear capabilities.

Canadian researchers are developing a DNA vaccine for SARS-CoV-2, the coronavirus that causes COVID-19 and has currently infected nearly 5,00,000 people worldwide and crippled the global economy.

Entos Pharmaceuticals, a health-care biotechnology company headed by a University of Alberta researchers, develop new therapeutic compounds using the company's proprietary drug-delivery platform and has begun manufacturing vaccine candidates against the novel coronavirus.

"Given the urgency of the situation, we can have a lead candidate vaccine within two months. Once we have that it's a race to get it into clinical trials," said John Lewis, CEO of Entos and a Professor at the University of Alberta in Canada.

Lewis said in comparison to a traditional vaccine, DNA-based vaccines hold several advantages.

Nucleic acids are introduced directly into the patient's own cells, causing them to make pieces of the virus--tricking the immune system into mounting a response without the full virus actually being present, the researcher said.

According to the company, the approach is recognised as being easier to move into large-scale manufacturing, offers improved vaccine stability and works without needing an infectious agent.

In the current absence of a vaccine for COVID-19, several companies around the world are mounting efforts to begin similar work.

The first clinical trial using a DNA-based vaccine developed by Moderna Inc.in the US on March 13.

Their approach allows for antibodies to be made in the human trial volunteers against a specific protein on the surface of the coronavirus that lets the virus enter human cells.

The hope is that the antibodies will stop the interaction.

Though this approach is designed to be effective against COVID-19 specifically, Lewis said Entos is taking a different tack.

The company plans to use plasmid DNA to amplify the production of key coronavirus surface and structural proteins with each injection, with an eye to the bigger picture.

"Many of the structural proteins in the virus are pretty well conserved across all the coronaviruses, including SARS and MERS," said Lewis.

"We're hoping that if we express more of the structural proteins that are common to most coronaviruses, we can inhibit the current COVID-19, and also potentially protect against all coronaviruses both past and future," Lewis added.

To move the project forward quickly, the company is seeking financial support from both provincial and federal levels of government.

"We have the opportunity to save a lot of lives, and I think it's really upon us and governments to find solutions for that," Lewis said.