https://www.sabcnews.com/sabcn…medicine-clinical-trials/

Expert panel endorses protocol for COVID-19 herbal medicine clinical trials

20 September 2020, 12:06 PM | SABC Digital News | @SABCNews

Image: Afro.who.int

Phase 3 clinical trials are pivotal in fully assessing the safety and efficacy of a new medical product.

The Regional Expert Committee on Traditional Medicine for COVID-19 formed by the World Health Organization (WHO), the Africa Centre for Disease Control and Prevention and the African Union Commission for Social Affairs has endorsed a protocol for phase 3 clinical trials of herbal medicine for COVID-19, as well as a charter and terms of reference for the establishment of a data and safety monitoring board for herbal medicine clinical trials.

In the statement, Director of Universal Health Coverage and Life Course Cluster at WHO Regional Office for Africa, Dr Prosper Tumusiime says, “Just like other areas of medicine, sound science is the sole basis for safe and effective traditional medicine therapies.”

“The onset of COVID-19, like the Ebola outbreak in West Africa, has highlighted the need for strengthened health systems and accelerated research and development programmes, including on traditional medicines,” says Tumusiime.

The endorsed technical documents are aimed at empowering and developing a critical mass of technical capacity of scientists in Africa to conduct proper clinical trials to ensure quality, safety and efficacy of traditional medicines in line with international standards.

Phase 3 clinical trials are pivotal in fully assessing the safety and efficacy of a new medical product.

The data safety and monitoring board will ensure that the accumulated studies data are reviewed periodically against participants’ safety. It will also make recommendations on the continuation, modification or termination of a trial based on evaluation of data at predetermined periods during the study.

Expert panel endorses protocol for COVID from SABC News

In South Africa, the use of Artemisia to fight COVID-19 in rural areas on the increase:

Was this really necessary in the first place?

Covid/Corona is, arguably, the most hyped, most destructive but yet least deadly "pandemic" in history.

In Africa the infection rate to date is over 1 million. That is 1 million out of a population of over 1 billion, 0.1%. South Africa, the country with the highest numbers of 500 000 infections from a population of 60 million, still also comes out to just 0.09%. Even without measures it would likely not have been much different. Regular flu is much worse but nobody shuts down for that.

But, in the end, the statistics are irrelevant. As a force for change COVID has succeeded greatly. The old world is gone...or going...as the new is coming...it's just not all quite so apparent yet.

https://ewn.co.za/2020/08/05/u…ica-nears-1-million-cases

UGANDA'S TOUGH APPROACH CURBS COVID, EVEN AS AFRICA NEARS 1 MILLION CASES

As the number of cases in Africa approaches one million, Uganda’s experience shows what can be accomplished when a government with a firm grip on power acts quickly and enforces a strict lockdown.

FILE: Uganda's President Yoweri Museveni.

Picture: AFP

Reuters | 6 August 2020

KAMPALA – Uganda’s crumbling public hospitals, doctors’ strikes and corruption scandals make its success in the fight against the new coronavirus all the more unlikely.

But the nation of 42 million people has recorded just over 1,200 cases and five deaths since March, a strikingly low total for such a large country.

As the number of cases in Africa approaches one million, Uganda’s experience shows what can be accomplished when a government with a firm grip on power acts quickly and enforces a strict lockdown. But its success came at a cost, critics say.

Jobs were lost, and economic growth is set to plunge to as low as 0.4% in 2020, from 5.6% last year, according to the World Bank.

Some pregnant women died in labour, unable to reach hospitals because of travel restrictions. Security forces - criticised by rights groups for abuses - beat and arrested some rule-breakers.

Opposition leaders accuse the government of using the pandemic as an excuse to restrict political gatherings and arrest opponents charges the government denies.

“A jobless person is better than a dead person,” state minister for health Robinah Nabbanja told Reuters. “The lockdown was completely justified.”

LOCKDOWN

Uganda’s approach contrasts with that of many other African countries, which did not impose such strict measures and began easing them long before infections peaked to protect their fragile economies and mostly poor populations.

Some now face rapidly accelerating outbreaks that could overwhelm their public health systems, the World Health Organization (WHO) has warned. Uganda’s stringent measures bought the government time to prepare its health system and learn lessons about the disease, said Tim Bromfield, regional director for East and Southern Africa at the Tony Blair Institute for Global Change, a UK-based think-tank.

“All governments are balancing lives versus livelihoods.”

Uganda closed schools and banned large gatherings three days before confirming its first case on 21 March. By the end of March, most businesses were shut, vehicle movement was banned, and an overnight curfew was in force. Masks became mandatory in public in May.

The East African nation’s response was shaped by battling deadly infectious diseases like Ebola and Marburg virus, public health experts said.

The country was already on alert because of an Ebola outbreak in neighbouring Democratic Republic of Congo when COVID-19 hit, said Alex Ario, director of the government-affiliated National Institute of Public Health.

Teams were in place to educate the public and trace those infected. Passengers were already being screened at airports. Isolation wards were ready to receive patients, and anyone infected was hospitalised.

“Uganda knew where to conduct their surveillance,” said John Nkengasong, head of the Africa Centres for Disease Control and Prevention. “The lesson from them is you should know your pandemic.”

Uganda - like China - could enforce aggressive containment measures with little domestic opposition.

In March, local media carried images of a paramilitary force beating fruit vendors and pedestrians for breaking work and travel restrictions. Military spokesperson Brigadier Flavia Byekwaso said they were “overzealous in enforcing the measures.” Bruce Kirenga, who heads the Makerere University Lung Institute, said strong public health measures likely reduced the amount of virus in circulation.

He noted that around 95% of Uganda’s cases are asymptomatic or very mild. Some scientists suggest that patients exposed to a higher number of pathogens develop more severe cases.

HUNGER BITES

Neighbouring Rwanda, which also took an aggressive approach, has recorded five deaths in a country of 12 million. Other countries with low fatalities include the small island nation of Seychelles, which quickly closed its borders and had no deaths, and Botswana, which has fewer than 2.5 million people and two deaths.

South Africa imposed one of the world’s strictest lockdowns when it had just 400 cases. But the measures battered its struggling economy, and the government began easing some of them within weeks, under pressure from business leaders, trade unions and opposition parties.

It now faces a runaway epidemic that accounts for roughly half the continent’s 975,000 cases and 21,000 deaths. Public health experts believe the number of infections and deaths in Africa is higher than official figures suggest, noting low levels of testing in most nations. But with a few exceptions, countries have not reported hospitals being overwhelmed.

Uganda’s figures are considered more reliable than most: it has carried out more than 250,000 tests and works closely with international institutions, said Dr Peter Waiswa, a public health expert at Makerere University College of Health Sciences.

Uganda is now easing its lockdown, but people like Wilson Munyakayanza want it lifted. The father-of-three has not worked since losing his job as a bar manager in March.

“I go hungry sometimes and eat only once in a day,” he said. “Coronavirus hasn’t killed us but the hell of going hungry is not that far from death.”

^{This could be called "quackery" or "witchdoctoring" but African's knowledge of natural medicine is extensive. Unfortunately some do use it for superstitious quackery which diminishes its legitimacy for an observer.}

^{https://www.sabcnews.com/sabcn…ional-medicine-in-africa/}

WHO, Africa CDC launch committee to provide scientific advice on traditional medicine in Africa

25 July 2020, 11:58 AM | SABC Digital News | @SABCNews

Image: File Image: SABC News

The 25-member Regional Expert Committee on Traditional Medicine for COVID-19 will support countries in collaborative efforts to conduct clinical trials of traditional medicines in compliance with international standards.

The World Health Organization (WHO) and the Africa Centres for Disease Control and Prevention (Africa CDC) have launched an expert advisory committee to provide independent scientific advice and support to countries on the safety, efficacy and quality of traditional medicine therapies in Africa.

The 25-member Regional Expert Committee on Traditional Medicine for COVID-19 will support countries in collaborative efforts to conduct clinical trials of traditional medicines in compliance with international standards.

In a press statement, Africa CDC says, “By pooling expertise within the continent, the Regional Expert Committee will also accelerate the pace and elevate the standards of research, particularly clinical research on new therapies from traditional medicines against COVID-19. WHO recognizes that traditional, complementary and alternative medicine has many benefits and Africa has a long history of traditional medicine and practitioners that play an important role in providing care to populations.”

Members of the Regional Expert Committee are mainly from research institutions, national regulatory authorities, traditional medicine programmes, public health departments, academia, medical pharmacy professions and civil society organizations of Member States.

Their expertise covers various areas such as traditional medicine research and development, laboratory and pre-clinical research; clinical research; regulation of medical products; research ethics; public health and community empowerment; leadership and governance; laboratory strengthening and infectious disease.

Below is the full statement:

Who, africa cdc in joint push for covid 19 traditional medicine research in africa from SABC News

Madagacar

In May, the Africa CDC said it was looking at Madagascar’s organic remedy.

This comes after the African island nation claimed to have produced a herbal tonic from a plant. The country said it is effective for the prevention and treatment of COVID-19.

Some African countries have ordered the tonic despite the World Health Organisation’s warning that it has not been subjected to any scientific testing.

In the video below, Africa CDC’s Dr John Nkengasong addresses the media:

I never trust the numbers anyway and perhaps Gamma has something to do with this as well.

https://www.news24.com/news24/…nd-excess-deaths-20200723

Researchers find 'huge discrepancy' between reported number of Covid-19 fatalities and excess deaths

Kyle Cowan

(File)
PHOTO: Gallo Images/Darren Stewart

• An estimated 17 090 more natural deaths than expected between 6 May and 14 July has raised concern about the accuracy of reported Covid-19 deaths.
• Excess mortality is a measure used internationally to decipher actual deaths during large-scale epidemics.
• It remains unclear why so many South Africans are dying, if it is not related to Covid-19.

South Africans are dying at a much higher rate than expected as Covid-19 continues to spread at a significant pace in at least three provinces.

Excess deaths between 6 May and 14 July topped 17 000, according to the latest research by the South African Medical Research Council (SAMRC) and University of Cape Town's Centre for Actuarial Research.

"In the past weeks, the numbers have shown a relentless increase – by the second week of July, there were 59% more deaths from natural causes than would have been expected based on historical data. It also means that reported deaths have shown a pattern that is completely different to those indicated by historical trends," the SAMRC said in a statement on Wednesday.

Professor Debbie Bradshaw, a co-author of the report, said the "timing and geographic pattern leaves no room to question whether this is associated with the Covid-19 epidemic".

"However, the weekly death reports have revealed a huge discrepancy between the country's confirmed Covid-19 deaths and the number of excess natural deaths," she added.

As of 21 July, the number of confirmed Covid-19 deaths was 5 368.

Key takeaways from the latest report for excess mortality up to 14 July:

• Between 6 May and 14 July, excess deaths from natural causes were 17 090 for persons one year and older.
• For people between the ages of one and 59, the excess number of deaths is 5 889 and 11 175 for people 60 and older.
• The Western Cape, Eastern Cape, Gauteng and KwaZulu-Natal are experiencing excess natural deaths. These are the hardest-hit provinces in terms of confirmed Covid-19 deaths and cases.
• Mpumalanga, the Free State, Limpopo and North West have also started showing increases in excess deaths from natural causes.

The number of natural deaths, weekly, nationally. (Source: SAMRC-UCT Weekly Mortality Report 22 July 2020).

The authors of the weekly report include Bradshaw, Ria Laubscher, Professor Rob Dorrington, Professor Pam Groenewald and Professor Tom Moultrie who, together and individually, comprise a highly accomplished and qualified team of some of the country's foremost experts in demography, statistics and mortality.

Professor Glenda Gray, the CEO and president of the SAMRC, said the council had been tracking mortality for decades.

"This system has identified excess deaths associated with the Covid-19 epidemic. These may be attributed to both Covid-19 deaths as well as non-Covid-19 due to other diseases such as TB, HIV and non-communicable diseases, as health services are re-orientated to support this health crisis," she added.

Excess deaths

The excess is calculated using the number of reported deaths from the National Population Register (NPR), which is maintained by the Department of Home Affairs. A forecast is calculated based on the number of deaths reported from natural and unnatural causes in past years.

The forecast is also calculated with an upper and lower expectation bound.

The team then uses documented weighting methods to account for multiple variables that could affect the true number of deaths other than what is reported in the NPR data.

According to the SAMRC, there were different ways in which excess deaths were calculated.

"Some analysts take the excess above the expected number based on historical data, while others take the number above a threshold such as the upper prediction bound i.e. significantly higher than expected," the SAMRC said in a statement on Wednesday.

"In general, these excess deaths are calculated using all-cause mortality. It is considered that excess deaths would comprise Covid-19 deaths that are confirmed, Covid-19 deaths that have not been confirmed, as well as other deaths that may arise from conditions that might normally have been diagnosed and treated had the public been willing and able to access health care."

Table showing estimated excess deaths as at 14 July. (Source: SAMRC-UCT Weekly Mortality Report 22 July 2020).

In an information sheet shared along with the latest report, the authors acknowledge there was uncertainty about the exact number of excess deaths. They said the uncertainty arose from having to estimate not only the actual number of deaths, but also what would have happened without the Covid-19 pandemic.

"We have reported the challenges that we face and the method that we have used. Our estimate excess natural deaths could be revised should an improved method be identified.

"However, given the timing and geographic spread of the increases seen in the natural deaths, there can be no doubt that the bulk of the increase is related directly or indirectly to Covid-19."

The authors consider the gap between the number of excess deaths and confirmed Covid-19 deaths probably comprises:

• People dying from Covid-19 before they get to a healthcare facility.
• People dying from Covid-19 but the death not being reported as such.
• People dying from non-Covid-19 conditions because health systems have been orientated to Covid-19 patients.

Testing constraints in the public sector also mean many cases are being picked up only when people arrive at healthcare facilities.

Challenge

"Faced with the challenge that South Africa had a stringent lockdown in the very early stage of the epidemic and that unnatural deaths are a higher proportion of the all-cause mortality [and were impacted very significantly by the stringent lockdown], the SAMRC-UCT team thought it was necessary to use a different approach," the SAMRC statement read.

The SAMRC said:

To quantify the impact of the Covid-19 epidemic on South African deaths, it was decided to focus on deaths from natural causes and remove the impact of changes in the unnatural deaths.

"The team also thought it would be necessary to consider that the lockdown had reduced the number of natural deaths. Thus, a baseline was chosen that was consistent with the level that the number of natural deaths was tracking prior to the uptick in the trend."

Bradshaw said the weekly death reports have contributed important information to complement other data on the unfolding of the epidemic. "The report was able to confirm that no epidemics had occurred prior to the first Covid-19 cases identified by the National Institute for Communicable Diseases (NICD) and the country's first death announced by Health Minister Dr Zweli Mkhize in March. It was through these reports that the early growth of the epidemic in Cape Town and the Western Cape was confirmed, followed by the spread in Nelson Mandela Bay and the Eastern Cape."

As of 14 July, the number of deaths from unnatural causes such as car accidents and murders was 20% below expected totals.

The number of unnatural deaths weekly. (Source: SAMRC-UCT Weekly Mortality Report 22 July 2020).

https://www.sabcnews.com/sabcnews/south-africas-leaders-have-had-a-crack-at-covid-19-its-time-to-give-the-people-a-go

South Africa’s leaders have had a crack at COVID-19: it’s time to give the people a go

19 July 2020, 7:29 AM | The Conversation | @SABCNews

Image: Reuters

South Africa’s initial response to COVID-19 was confident

South Africa is now ranked 5th in the world for COVID-19 active cases, 9th for cumulative cases, and 23rd for cumulative deaths.

The nation’s leadership was initially widely praised for reacting decisively and early by implementing stringent lockdown regulations. These have been successively eased since they became unsustainable.

The president has recently announced new regulations. Some, like the ban on alcohol sales, are designed to alleviate the burden on the healthcare system. These make sense. But those regulations designed to slow transmission do not. They are variations on familiar themes: curfews, continued restrictions on social and economic activities, regulations on taxi operation, and similar.

Regulation is entirely the wrong approach. Lockdown failed in South Africa, despite its huge cost. The emphasis should never have been on imposing restrictions. It should have been on asking people in different parts of the fantastically complex mosaic of South African society to participate in coming up with solutions.

People know their own way of life, and can identify solutions that work for them. Even if there are none, we all deserve a say in how to balance the risks we face. There is no avoiding the coming storm, but the country can prepare for it by settling on a strategy informed by realism – about what has and hasn’t worked, and about what is feasible in South Africa.

What hasn’t worked

It is obvious that lockdown failed to avert the current situation, since we are in it. It is less widely appreciated that there were no changes in the trajectory of COVID-19 either during the locking down or in the unlocking phases. The infection rate, viewed on a logarithmic scale (because the linear scale makes changes harder to spot), is roughly a straight line from about 28 March onwards. That was Day 2 of lockdown – far too soon for an effect. This means that the reproduction number has remained approximately the same for over three months. (Deaths look similar, with a time lag.) This is obscured on a linear scale, because it is hard to spot changes in a curve. But when viewed with a logarithmic y-axis, it is obvious that the line is approximately straight. Lockdown didn’t make a difference, and nor did unlocking, as Figure 1 shows.

Source: Author.

South Africa’s current predicament is a continued, steady growth in incidence rate. This on the back of the huge socioeconomic impact of lockdown:

• decimation of the economy;
• loss of employment and livelihoods;
• collapse of many small, micro and medium-sized businesses;
• growing hunger;
• disruption to important existing health programmes; and
• enormous psychological pressure felt by nearly everyone in the country.

Given these consequences, the last thing South African lawmakers should be considering is a further lockdown.

So is the country out of options?

Not exactly.

Ask the people

The road not taken was a considered mitigation strategy, instead of a copycat approach – one that persists as the country unlocks in step with the rest of the world.

The approach, advocated unsuccessfully by some both before and nearer the time of locking down, is to identify context-specific measures that result in reduced infection rates while permitting as much normal activity to proceed as possible.

How does one devise a context-specific mitigation strategy? One doesn’t. Instead, one asks the people who actually live in that context.

Some months ago, I was involved in making a documentary about the effects of lockdown in low-income settings. Interviews were conducted with people living in poverty in both urban and rural settings in Uganda, Malawi, Zambia and India. The common thread in these interviews was their frustration at not being heard.

Most of them feared starvation more than COVID-19. Something else was apparent too. Several people had their own ideas about how to deal with the threat.

In particular, the leadership of a Malawian village came up with a solution to protect older people by locating them in one part of the village. Malawi never locked down but, with a very poor population, half of whom are 17 or under, it is really not clear why it should. Had Malawi’s then-leaders consulted, they might never have suffered the ignominy of having their obviously inappropriate lockdown regulations thrown out by a court.

The road not taken, then, is consultation. It sounds watery, but it’s not. Humans are problem-solvers: that’s our special skill. But we have to know what the problem is, and what tools are available in the context. So long as the people who understand the problem don’t talk to the people who know the context, the chances of solutions are small.

It’s not too late. South Africa’s best bet now is to provide communities with accurate information about how COVID-19 spreads and whom it threatens, exactly as happened in the interaction in Malawi, and then ask them what they want to do about it.

Different steps for different circumstances

Nobody wants to catch coronavirus, and people will take reasonable steps to avoid it. But in this most unequal of countries, those steps will be quite different for different people.

For an office worker living in the suburbs on an uninterrupted salary, working from home and having food delivered and avoiding public places makes sense.

Waste-pickers, hawkers, restaurateurs, taxi-drivers, hairdressers, and domestic workers all live differently. They are all exposed to different risks. They are also faced with different imperatives against which to balance those risks.

By consulting communities, government would also begin the process of rebuilding trust, which was squandered in the attempt to enforce a strategy that was obviously impossible here.

“Suppression” of the virus, as defined in the influential report from Imperial College London, is the reduction of the reproduction number below one, achieved by a 60% reduction in social contact.

That was never on the cards for South Africa. And ordinary South Africans knew it.

South Africa’s initial response to COVID-19 was confident, but wrong. Now it has stalled. But the country is not out of options. The trick is for the chattering classes to stop telling each other what the solution is, and instead ask some of those who haven’t been heard. The leaders have had their chance. It’s only fair that the people have a go.

It’s unlikely they will perform worse.

Alexander Broadbent, Director of the Institute for the Future of Knowledge and Professor of Philosophy, University of Johannesburg

This article is republished from The Conversation under a Creative Commons license. Read the original article.