Denial of USD 350mn aid to Pakistan reality, not policy: United States

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.

May 30: Warning of the tightrope walk ahead as governments battle the coronavirus crisis, Nobel laureate Peter Charles Doherty has expressed concern about densely populated countries such as India relaxing lockdown norms while also describing a complete shutdown as “an economic and social impossibility”.

The Australian immunologist, who cautioned that the number of COVID-19 cases will rise in the coming days, said the earliest time frame for an effective vaccine “going into large numbers of people” is nine to 12 months.

"If all goes well with testing, we could know if some of the candidate vaccines are both safe and effective as early as September/October. Then, rolling a vaccine out will depend on the type of product and how quickly it can be made, put in vials and so forth," Doherty told PTI in an email interview from Melbourne.

The novel coronavirus, he added, does not change fast like influenza and, from what is known so far, “the same vaccine should work everywhere”.

Doherty, who is with the Department of Microbiology and Immunology at the Doherty Institute, University of Melbourne, won the Nobel Prize for Medicine in 1996 for his discovery of how the body’s immune system distinguishes virus-infected cells from normal ones.

Discussing the lockdown, he said, "If it was purely a matter of hard science, everywhere should stay locked down. But that’s pretty much an economic and social impossibility.”

The expectation, he said, is the numbers will rise and limiting spread will depend on people acting responsibly and the capacity for rapid response and extensive contact testing.

“And in a densely populated country like India I think that it will be very difficult," the scientist said.

Several countries, including India, began relaxing lockdown norms in mid-May despite the WHO’s warning about a second wave. India’s lockdown began on March 25 and has since been extended. The fourth phase ends on Sunday.

Asked whether there are any alternatives to a lockdown, the 79-year-old said, "There is no other option other than closing borders. South Korea, for example, conducted massive, intensive testing and contact tracing in a wealthy country with a very disciplined population. Otherwise, not till we have effective vaccines."

He added that he personally doesn’t see the point of closing borders for people coming in if there’s already a high incidence of disease in the community, “unless it’s to avoid the need to care for them and use scarce hospital beds".

According to Doherty, the coronavirus "is a new virus which has come straight out of nature".

“It (the virus) has moved so rapidly across the world because of people travelling on international planes as well as tourist ships," he added.

The immunologist also warned against the use of hydroxychloroquine to treat COVID-19, and said current and planned trials of the anti-malaria drug should be stopped.

“My understanding is that the use of the drug in severe disease is definitely contra-indicated, but it’s not yet clear whether, if taken under medical supervision, it could have some useful effect if taken early on, or as a preventive. Those trials just haven’t been done properly," Doherty noted.

The Indian Council of Medical Research (ICMR) has backed the use of hydroxychloroquine as a preventive against COVID-19 even after the WHO suspended clinical trials of the drug citing safety concerns.

Asked whether plasma therapy can be an effective treatment for COVID-19, Doherty said, "We lack good properly controlled trials but, especially if the plasma has been tested for antibody levels and there’s evidence of good activity, it could be helpful. If I had the disease and was offered plasma therapy I would certainly accept, but I would not take hydroxychloroquine."

Doherty is also very optimistic about herd immunity developing against the SARS-CoV-2 infection.

"We think that (herd immunity) will cut in and have an obvious effect when, say, 60 per cent of people have been infected. Best hope is to boost herd immunity with a vaccine," he stated.

Herd immunity is a form of indirect protection from infectious disease that occurs when a large percentage of a population has become immune to an infection, whether through vaccination or previous infections.

The number of COVID-19 cases have crossed 5.9 million and the fatalities 3,65,000, according to the Johns Hopkins University on Saturday. 

In India, the death toll has risen to 4,971 and the number of cases to 1,73,763, according to the Union Health Ministry on Saturday.

Several states, including Bihar, Uttar Pradesh, Madhya Pradesh, Jharkhand and Chhattisgarh, have reported a rise in number since lockdown norms were relaxed in early May and migrant workers reached home.

In Uttar Pradesh, for instance, the number of infections rose from around 3,000 on May 4 to 6,532 on May 26. Similarly, Bihar’s numbers increased from around 500 to over 2,700 in the period.

Geneva, Apr 23: The World Health Organisation (WHO) on Wednesday (local time) said that the COVID-19 crisis will not end any time soon, with several countries only in the initial stages of the fight against the virus.

"Make no mistake, we have a long way to go. Coronavirus will be with us for a long time. There is no question that stay at home orders and other physical distancing measures have successfully suppressed transmission in many countries," WHO chief Tedros Adhanom Ghebreyesus said in a press conference.

"Most countries are in the early stages of their epidemics. And some, which were affected early in the pandemic, are now starting to see a resurgence in the number of cases," he added.

COVID-19 has infected more than 2.6 million people around the world and a total of 1,83,027 people have died due to coronavirus, according to data from US-based Johns Hopkins University.