WHO COVID-19 Technical Lead Maria Van Kerkhove

‘’Less than 1%” of infected individuals die from the coronavirus according to the World Health Organization, marking the first time the agency has reported an ‘infection fatality rate’ for the general population. The virus is easily spread and more deadly in older people, making it a threat.

The remarks by WHO’s experts came just a few days after WHO’s Emergency Committee warned that countries should be preparing to deal with the pandemic in “the long term,” after meeting for the third time this year to determine the status of the pandemic. WHO Director-General Dr Tedros Adhanom Ghebreyesus declared that COVID-19 still constituted a Public Health Emergency of International Concern (PHEIC). 

WHO has cited a more commonly used case-fatality rate – the proportion of deaths among reported cases – of 3.4% based on a February report from China. The infection fatality rate, in contrast, is an estimate of the proportion of deaths in all those infected, including unreported cases. 

Easily Transmissible Viruses Can Kill Many People Despite Low Infection Fatality Rate

And despite the lower infection fatality rate estimate, 1% is still fairly high in such a prolific virus, and the IFR is even higher in older people or those with chronic conditions, warned WHO COVID-19 Technical Lead Maria Van Kerkhove. 

“Right now, it’s tough to estimate the COVID infection fatality rate (IFR), but current estimates hover between 0.6-1% [varying by age],” said Van Kerkhove, referring to a Lancet study from early June. “That may not sound like a lot, but it is quite high [given] the virus can transmit readily.”

Over the past three months, COVID-19 cases have skyrocketed by a factor of five to 17.5 million, and the number of deaths has tripled to 680,000, added Dr Tedros. And there is evidence the virus may even cause long lasting respiratory, cardiovascular, and neurological problems in those who survive.

“Everyone is feeling the fatigue of this pandemic, but we have a long way to go”, said Van Kerkhove.  We need to remain focused, we need to remain strong, we need to accept that this is challenging” and take advantage of the pandemic to build back better.

WHO Cites COVID-19 Infection Fatality Rate Estimate For The First Time  

Monday marked the first time WHO officially referred to the infection fatality rate (IFR) of  COVID-19, with an estimate ranging between 0.6 and 1%.

The infection fatality rate – often called the ‘true’ fatality rate – is tricky to determine during an outbreak, as it relies on understanding how many people in total are infected with a disease. Usually, the IFR can only be estimated after large seroprevalence surveys are done post-outbreak to measure the true extent of a diseases’ spread. 

As a result, the simpler ‘case fatality ratio’ is more commonly used to measure death rates as it relies on the number of reported cases, rather than the total number of infected people. However, the case fatality ratio usually overestimates the ‘true’ death rate, as it usually does not take into account unreported infections, such as those that may be asymptomatic or too mild to be detected.

The US Centers for Disease Control has estimated that up to 40% of all COVID-19 cases are asymptomatic, in their pandemic planning scenario guidelines.

Image Credits: WHO.

Besik, a TB patient at the TB Alliance’s clinical trial site in Tbilisi, Georgia, takes his medication.

Amidst the battle against a new infectious threat, the fight against tuberculosis, one of humankind’s oldest recorded infectious diseases, is also progressing.

Pretomanid – only the second TB drug to hit the market in over two decades – received conditional marketing approval Monday from the European Commission as part of a new, three-drug treatment regimen for drug-resistant TB. The new six-month, all-oral regimen containing pretomanid, bedaquiline, and linezolid, was authorized for treatment of adults with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) whose disease does not respond to other therapy or who could not tolerate their therapy.

TB Alliance President and CEO Mel Spigelman

The EC approval follows just on the heels of the regimen’s approval in India, the country with the highest burden of TB in the world, marking two big regulatory advances for the new treatment.

Health Policy Watch sat down with President and Chief Executive Officer of the TB Alliance Dr. Mel Spigelman to discuss the state of TB in the world today, how the BPaL regimen approval impacts TB treatment, and what commitments are ultimately required to control this age-old scourge.

HP Watch: Some studies have predicted there could be 1.4 million more TB related deaths in the next five years due to COVID-19 related disruptions. What is the state of TB in the world right now given the pandemic?

Mel Spigelman: Obviously, it depends country by country. But in general, the state of TB, in terms of health services, was never great. So we were starting off from a pretty low level. Clearly there’s a limited amount of health services, and prioritization is being given to COVID-19, so there’s no question in my mind that health services for TB are suffering.

And it’s not just because of health services being pulled away. It’s so much more difficult for the patient to get to a treatment center even if it is open. It’s difficult to get to treatment. Frankly it’s not completely different than in a country like the United States, where people are also not necessarily taking care of all their health problems because of the fear of limited access that has been made worse than usual because of COVID-19.

So yes, the pandemic definitely is taking its toll on TB resources, facilities and patients’ access. There’s no doubt in my mind that will result in a worse prognosis for TB patients around the world. Whether it’s going to be 1.4 million or 1.7 or 1.2 million more deaths no one knows. But it is having a significant impact and will have a significant impact.

TB patients must go to treatment centers for regular exams. Some patients are hospitalized.

HP-Watch: You mentioned patients’ access to treatment centers has been impacted. Can you explain how treatment for TB is set up in most countries – are countries doing direct-observation therapy or home-based models? What challenges have COVID-19 lockdowns brought to these treatment models?

MS: Frankly not every country does directly observed therapy, so patients don’t necessarily come in every day by any stretch in many countries, and clearly there have been movements towards making it more user friendly. Many countries have home-based models – there are Community Care people who come to check on patients.

But still, patients still need to come into treatment centers periodically to do things like have their sputum checked and pick up the medication. So patients still need to access treatment facilities.

And then you get to issues like drug-resistant TB. In many countries, patients with drug-resistant TB are hospitalized for a part of their treatment. Some of these hospitals have been closed down and converted into COVID hospitals.

It’s not a question of rigidity on the part of the providers. It’s simply a result of scarce resources to begin with. So many have been pulled away, or because of travel and other restrictions, they’re just not accessible now. And even home-based therapy is difficult to carry out when a country is in a lockdown. Community-based workers can’t necessarily get to the homes of the many patients. Lockdowns have a profound effect throughout the whole chain of care providers.

HP-Watch: Earlier in the pandemic, a COVID-19 diagnostic test was developed for the GeneXpert system, which is being used to diagnose TB in many high burden countries. But you have mentioned that there are already scarce resources dedicated towards TB. How have (or have not) countries been synchronizing their COVID and TB responses? Is there more potential to synergize the response to both this old threat and new pandemic?

MS: I think the countries are doing as good a job as they can given the realities, based on what our investigators and physicians are doing in the countries where we have study sites. I just hope in retrospect, one of the lessons learned will be that we need to wake up, both on the country level in non-TB endemic countries, and in the international community, and realize that health issues require much much greater commitment than what has so far been assigned or given to them.

In the past, and that’s especially true for diseases of poverty like TB, they get relatively less attention, less resources than even other diseases, even within the construct of medical care. So the whole system needs to be really notched up quite a few rungs.

Pretomanid, approved recently by the EC and India as a new treatment for multi-drug resistant TB as part of the BPaL regimen.

HP-Watch: So a new tool, pretomanid, has been developed by the TB Alliance, and could drastically change the face of TB care, especially for patients with drug resistant TB. How does the recent approval of the pretomanid regimen in Europe help advance the fight against the disease?

MS: For the appropriate patients, we can use this pretomanid treatment to go from 18 months or so of treatment down to six months. That makes a big difference in terms of freeing up the healthcare system, making it possible to treat a lot more patients for the same amount of resources. The treatment has a high cure rate – in the range of 90%, and you only have to take three drugs orally instead of what has historically been up to eight or nine.

While in most of the countries of the European Union, TB is frequently looked at as a disease of the past, there are countries and areas within Europe wherein the percentage of TB infections that are resistant to available treatments is in fact higher than in most other regions in the world.  Approval in the EU provides a new option for patients with highly drug-resistant forms of TB, that has the potential to reshape this treatment landscape.

The availability of pretomanid and the BPaL regimen is also something of a return on investment for our European donors, who are committed to tackling public health threats both at home and abroad. We are profoundly grateful to the governments of Germany, Ireland, the Netherlands and the United Kingdom for their significant long-term support of our research and product development.

HP-Watch: India has become one of the worst affected countries in the world in the COVID-19 pandemic, and has the highest burden of TB in the world. But they also just recently approved this new pretomanid combination treatment that the TB Alliance developed. Can you give me a snapshot of what India looks like right now?

MS: They are unfortunately getting hammered. Yes, they have the highest TB burden in the world and it appears that COVID-19 is becoming a greater and greater problem in the country. It is difficult for a country like India with such a large population and large amount of poverty to cope with these challenges. But, that’s where we’re hopeful that the BPaL regimen, with the new drug pretomanid, can help ameliorate some of these issues by making treatment of the highly resistant forms of TB easier and less expensive.

These are the solutions that have to be found in order for countries like India to have a shot at really getting control of both TB and COVID-19. Obviously, everybody is painfully aware of the limitations today of COVID therapy or COVID vaccinations, but at least there is a huge amount of resources dedicated to finding those tools for COVID-19, which is appropriate. Hopefully, that sends the message that this is what it takes to really get on top of a pandemic and keep it under control. Finding the tools it takes to control a pandemic is just a higher probability when you put $10 billion behind it, instead of a couple of hundred million.

Dr Abhijit Bhattacharya, MS, assesses an x-ray of a TB patient at Central Hospital Kalla, Eastern Coalfields Ltd. (Photo: ILO Asia)

HP-Watch: Speaking of funding for new tools, can you talk a little more about what the TB research landscape looks like right now?

MS: We have the largest pipeline of potential treatments ever in TB history. But it just pales in comparison to what it should be if we wanted to really make rapid progress. Frankly, I don’t foresee another drug coming to market soon. The FDA has now approved two new drugs in the past 20 years for TB, which is the largest single infectious disease killer in the world. And that’s not an indictment of the FDA. That’s an indictment of the resources that are directed into these spaces to allow organizations to really do the work necessary to discover and develop new therapeutics. The funding situation is certainly just as dire with TB vaccines and diagnostics.

You look back in any disease area where there is a significant infusion of resources, such as COVID or cancer, and we almost invariably do much better. Over the course of just the past six months we already have two drugs, remdesivir and steroids, that have shown potential to treat COVID-19. That could not have happened without a huge amount of effort, a huge amount of resources. Now, remdesivir and steroids are repurposed drugs but nevertheless, we’ve only had two new drugs like that for TB in the past 20 years.

I can guarantee you if we had the resources, we’d have multiple new drugs on a very rapid basis. The money that has gone into TB has been used very wisely. And we’ve been fortunate actually in having the progress that’s been made, but it’s certainly not sufficient to meet the needs of the field.

Researchers test patient samples at a TB Alliance clinical trial site in Tbilisi, Georgia.

HP-Watch: Jumping back to the pretomanid approval in India, what’s the next step to rolling it out?

MS: The Indian government will be rolling it out selectively within the national TB program. And this is always the case with any new product; you need to educate people on how to use it, you need to prove that it works within your unique setting and healthcare system, etc.

They will start at selected sites and collect their own data because unfortunately we didn’t do any of the clinical trials in India so we have minimal experience for the BPaL regimen in Indian patients. We expect the results in India to be the same as in other countries, but we always want to be sure. And then there will also hopefully be more clinical trials going on simultaneously, looking at how to make the treatment more effective, using it in different combinations, etc.

But again, everything that one tries to do in the midst of this pandemic is 10 times more difficult in some ways. We’re certainly seeing that also in terms of rollout of pretomanid in many countries. Frankly, I give the Indian government and Mylan, our partner that really drove the approval process in India, all the credit in the world that they have approved this regimen so quickly. It’s been unbelievably efficient given the timing that we usually see for TB.

HP-Watch: So to end, we’re not on target to meet the 2035 goals to reduce new TB cases by 90% and to reduce TB deaths by 95%. What do you think needs to happen to ultimately meet those goals?

MS: A huge amount. First, we need better tools; we need a vaccine, a point of care diagnostic, and even more rapidly effective and safe drugs.

And we also need to strengthen healthcare systems. Even if you have new tools that are great, you still have to have very functional healthcare systems that have the resources to deliver the tools and oversee patients.

And it just means a much greater appreciation for and commitment to what it takes to turn diseases into relics of the past. It all just really comes back to, are donors and investors willing to put more skin in the game? Because if no one is willing to do that, I’m hard pressed to think of anything you can accomplish if you don’t have resources to get there.

A TB treatment center and one of the TB Alliance’s clinical trial sites in Cape Town, South Africa

Image Credits: Dato Koridze/STUDIO for TB Alliance, TB Alliance, Dato Koridze /STUDIO for TB Alliance, International Labor Organisation Asia.

PMI sponsors Ferrari through the Mission Winnow, a campaign dedicated towards promoting alternatives to combustible cigarettes, like e-cigarettes.

The racing sport Formula 1 (F1) has made more than US $4.4 billion in advertising and sponsorship from tobacco companies in the past seven decades, according to a report published by F1 industry monitor Formula Money and global tobacco industry watchdog STOP.

The first-ever analysis of its kind, Driving Addiction: F1 and Tobacco Advertising, was published just ahead of the British Grand Prix in Silverstone, scheduled for this weekend.

Phillip Morris International (PMI) and British American Tobacco (BAT), two tobacco industry powerhouses, are upping their spending on F1 this year, budgeting US $115 million in the 2020 season. In the 2019 F1 season, PMI and BAT spent US $100 million on sponsorship and advertising.

“For tobacco companies, the benefits are clear. This is a global sport that draws more than 500 million fans worldwide, mostly young and male—a prized demographic,” co-author on the report Caroline Reid said in a press release.

Of F1’s 500 million fans, 62% of new fans accumulated in the last two years were under the age of 35, according to the report. More than 90% of racing fans in the United States are male. Smoking is already more prevalent in young men than any other demographic, and few gains have been made in reducing the worldwide incidence of smoking in young men until recently.

F1’s governing body, the FIA (Federation Internationale de l’Automobile), made a public commitment in 2001 that it would ban tobacco sponsorship from international motor sport by 2006, in line with a World Health Organization treaty, the Framework Convention on Tobacco Control (WHO FCTC). In 2006, the commitment was watered down to a “suggestion” to turn down tobacco sponsorships. However, two decades later, the sport continues to accept tobacco industry involvement.

“PMI and BAT claim that they aren’t directly advertising cigarette brands. But according to trademarks registered by the companies, these brands are associated with tobacco products,” said Phil Chamberlain, a partner in STOP. “The money, ultimately, comes from manufacturing and selling products that contribute to the deaths of more than 8 million people every year.”

“The reality is that these deals promote tobacco use to the world at large, including children,”  a spokesperson from the World Health Organization told Health Policy Watch. “WHO encourages all sporting associations, including those governing motor racing, to prohibit tobacco advertising, promotion and sponsorship. This means taking effective action to ensure that member organizations do not permit tobacco advertising, promotion or sponsorship in any form.” 

Under its acceptance of the tobacco industry’s sponsorship, the F1 platform is also unable to partner with agencies like the WHO in order to promote health.

“Under rules created by WHO’s Member States, WHO does not engage with the tobacco industry or others that work to further its interests. This means that partnership with F1 or others providing a platform for the tobacco industry to promote tobacco use is off limits,”  said the WHO spokesperson.

Image Credits: Flickr: emperorrnie.

South African President Cyril Ramaphosa

Four months after South Africa implemented one of the strictest lockdowns in the world, it appears that neither lives nor livelihoods have been spared.

South African President Cyril Ramaphosa was widely praised for taking decisive action when he introduced one of the fastest and strictest lockdowns in the world in late March. Within three weeks of the country’s first case being identified, all residents had been ordered to stay at home for five weeks, and for a while it appeared as if the country was going to escape the worst of the pandemic.

But four months later, South Africa has the fifth highest COVID-19 caseload in the world after the US, Brazil, India and Russia. It accounts for over half of all African cases and the economic cost of the lockdown seems to have been in vain as the country is following the worst-case scenario sketched by epidemiologists.

And while the country recorded over half a million cases the first weekend in August, SA president Cyril Ramaphosa said that “the national lockdown succeeded in delaying the spread of the virus by more than two months, preventing a sudden and uncontrolled increase in infections in late March. Had South Africans not acted together to prevent this outcome, our health system would have been overwhelmed in every province. This would have resulted in a dramatic loss of life.”

Ramaphosa added that “the daily increase in infections appears to be stabilising, particularly in the Western Cape, Gauteng and Eastern Cape. Our case fatality rate – which is the number of deaths as a proportion of confirmed cases – remains at 1.6%, significantly lower than the global average.

“We have empowered our law enforcement to investigate all reports of alleged corruption and irregularities in the procurement of medical and other supplies. It is unconscionable that there are people who may be using this health crisis to unlawfully enrich themselves.”

But official COVID-19 death toll – reported to be 7,812 on 30 July – is also in doubt after the SA Medical Research Council reported on 22 July that there were 22,279 more natural deaths between 10 June and July 20 than expected, and these were concentrated in provinces with the highest COVID-19 cases.

South Africa saw a spike in deaths by natural causes between 6 May and 21 May 2020
Lockdowns Hurt Day Wage Workers

The dramatic effects of the lockdown were evident within days in a country where millions of people – citizens and economic migrants from neighbouring countries – are heavily dependent on a hand-to-mouth existence in the informal economy.

Feeding schemes were soon inundated and some reported queues up to four kilometres long, as people used to eking out a daily living from selling at markets became instantly destitute because they weren’t allowed to trade.

Some 47% of households reported running out of money for food in April, according to the National Income Dynamics Coronavirus Rapid Mobile Survey which was recently released.

The South African government appeared not to have anticipated such a rapid and dramatic economic catastrophe and it was forced to relax lockdown regulations on 1 May, and allow most sectors of the economy to open from 1 June.

“We are damned if we do, and damned if we don’t,” said Professor Salim Abdool Karim, the chairperson of the ministerial advisory committee (MAC), which provides scientific advice to the health minister.

“The WHO recommends an easing of restrictions only when cases start going down, but we would have had a lockdown for a very long time and had to deal with starvation. The regulations were not sustainable and we had to ease some,” Abdool Karim said in a radio interview last week.

“We were not in a position to ease restrictions on 1 June to allow for 70 to 80% of economic activity to resume, as cases were going up at the time. But each decision requires a fine balance. Right now, the economic decisions are a really a high priority,”  said Karim.

Volunteers in Philippi, Cape Town packing food parcels to be given out to the needy during the COVID 19 pandemic lockdown.
Contradictory Lockdown Policies Based On Politics Rather Than Science

But as the government seeks to balance health and the economy, its pandemic response has degenerated into a morass of contradictory regulations. Worse still, many appear to have been influenced by powerful lobby groups rather than by science or even economics.

Churches, casinos and restaurants  – identified as super-spreaders in other countries – have been allowed to operate for some time with certain restrictions.  But public parks and beaches remain closed.

From mid-July, minibus taxis, the main mode of transport for most South Africans, have also been permitted to operate at 100% capacity although Abdool Karim admitted that 50% capacity would be best from a health point of view.

At the same time, domestic leisure travel is banned even if people want to drive in their own cars to self-catering accommodation.

There is a curfew between 9pm and 5am, although scientists on the ministerial advisory committee say it will have no bearing on the spread of the virus. However, it has a significant impact on businesses such as restaurants need to close by 8pm to allow their staff to get home in time.

Sturks Tobacco Shop, considered one of the oldest businesses in Cape Town, South Africa. It was closed in 2020 due to COVID-19.

The sale of cigarettes has been banned since the lockdown started – ostensibly to get smokers to quit and thus protect them from severe COVID-19 illness. But this too has been condemned, even by scientists.

A large study of over 12,000 smokers released in late May found that only 16% had quit while over 90% had been able to buy cigarettes on the black market.

“The ban may well have undone the progress the South African Revenue Service had made in reducing illegal cigarettes prior to lockdown. It has given illicit traders a larger foothold in the cigarette market, and has created an opportunity for these traders to develop their distribution channels,” according to the researchers from the  University of Cape Town.

In addition, diabetes – rather than smoking-related conditions – has emerged as one of the most dangerous co-morbidities. Yet government has not banned junk food or sugary drinks that are fueling the country’s type two diabetes epidemic.

Last week, Ramaphosa announced that schools would be closed until 24 August against scientists’ advice who advocated that neither children nor teachers were more at risk in schools than communities.

However, a recent court order has compelled school feeding schemes to remain open, so children from low-income schools will still go to school to get food.

Political Corruption Difficult To Control

Depressingly, the pandemic has also provided opportunities for corrupt government officials to profit from tenders awarded to friends and relatives for a range of pandemic-related good and services, including the supply of food relief and personal protective equipment.

Numerous workers who have lost their jobs during the pandemic have also reported not getting the unemployment insurance fund (UIF) payments owed to them, while government has been slow to pay out a miniscule R350 (around 18 Euros) it promised to all unemployed South Africans between May and October.

Shoppers queue outside to observe social distancing measures during South Africa’s Level 4 lockdown.

Ramaphosa announced last week that he had empowered the corruption-busting special investigative unit (SIU) to investigate “allegations of corruption in areas such as the distribution of food parcels, social relief grants, the procurement of personal protective equipment and other medical supplies as well as the UIF special COVID-19 scheme”.

Media reports say that 90 companies are being investigated in one province alone, and that the corruption is estimated to have cost R2,2-billion (Euros 113 078 507) so far.

Sandile Zungu, head of Business Unity South Africa, described businesses profiteering from the pandemic as “parasitic COVID-pruners”.

“South Africa is becoming a nation of thieves, with the most unscrupulous enablers in official positions all too ready to feast on the relief meant for the most vulnerable in our society,” Zungu told a leading Sunday newspaper.

Ramaphosa’s promise to address the corruption has been met by skepticism. His administration has so far failed to act against his predecessor, Jacob Zuma, who looted billions and has brought the economy to its knees.

Ramaphosa beat Zuma by a narrow margin and was forced to make deals with various corrupt factions and individuals to do so, and lacks the power to take them on.

In addition, a number of his key allies in government have been infected with the virus and been forced to step aside. Four Cabinet ministers, three provincial premiers and the treasurer general of the ruling party are amongst those infected.

In the meantime, frustration and anger is building in communities as more people lose their jobs and young people lose hope of ever being able to find work.

This story was updated 3 August 2020 to included a public statement from Cyril Ramaphosa.

Image Credits: Wikimedia Commons: Discott, GovernmentZA, SA Medical Research Council, Wikimedia Commons: Discott, WIkimedia Commons: Thuvak.

Methicillin-Resistant Staphylococcus aureus (MRSA), a notorious bacteria resistant to many antibiotics.

The United Nations Interagency Coordination Group (IACG) is seeking candidates for a  “One Health Global Leaders Group” that will be established to fight the growing threat of antimicrobial resistance (AMR). 

Individuals from civil society and the private sector  are invited to submit an application to serve in the Global Leaders Group by 31 August 2020. Former Ministers of Health or senior government officials with experience in battling AMR will be nominated and considered through a separate process.

The One Health Leaders Group aims to advise global and national stakeholders to help control AMR, and advocate for more resources to be dedicated to controlling AMR. Membership will be 2-3 years long, with the possibility of a second 2-year term with agreement from the co-chairs and Secretariat.

Disease-causing microbes that are becoming resistant to common antimicrobials claim around 700,000 lives a year, according to the IACG, which represents the World Health Organization, the Food and Agricultural Organization, and the World Organisation for Animal Health. Rising antimicrobial resistance is caused by misuse and overuse of antimicrobials in humans and plants, pouring pharmaceutical waste in water sources and poor infection control measures.

Low and middle-IACG discussed Low and Middle Income Countries (LMIC’s) experiencing a greater burden of AMR;within poor basic services and weak healthcare systems while many are still suffering with implementing National Antimicrobial Resistance Action Plans. The Organization for Economic Cooperation and Development (OECD) anticipated 2.4 million deaths due to antimicrobial resistance in Europe, North America and Australia between 2015 and 2050.

Applications to the “One Health Leaders Group” must include Curriculum vitae (CV) of 2 pages (500 words) maximum and a motivation letter of 2 pages (500 words) maximum highlighting their contributions and what they will bring to the Global Leaders Group. Applications should be submitted to amr-tjs@who.int. More information, including terms of reference and an information note about the application, can be found here. 

The deadline for representatives from civil society and the private sector to apply for the “One Health Leaders Group” is 31 August 2020.

Image Credits: NIAID.

Orphan drugs receive ten years of market exclusivity in the EU to promote R&D for rare diseases.

Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades.

Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned into a “corporate cash machine” that has enabled market exclusivities to extend well beyond the ten years set by the EU’s regulations, preventing generic competitors to enter the market, said The Investigative Desk, a Dutch cooperative of investigative journalists that undertook the research.  The findings were published in the British Medical Journal (BMJ) and the Dutch Journal of Medicine (NTvG) on Wednesday. 

The number of orphan drugs earning over $1 billion in sales has skyrocketed in the past decade

The Investigative Desk’s research comes almost four months after researchers from international consultancy Technopolis Group presented an EU-commissioned review of the region’s orphan legislation to pharma experts from EU member states. The review suggests that the region’s regulations could be overcompensating big pharma for orphan drugs.

Surprisingly, the review also shows that an overwhelming majority of orphan drugs approved by the EU over the past twenty years would have been rolled-out regardless of receiving the EU’s orphan drug designation, suggesting the 21-year old approval process may not effectively spur R&D for rare diseases.

“The number of new orphan medicines which may be attributed to the EU Orphan Regulation, equates to 18 to 24”, said the review. “While these products would not have been available without the Regulation, the others [about 118 products] would have been introduced anyway, also thanks to their development in other regions, like the US.”

These findings, which will be officially published by the European Commission in a report later this summer, “may raise voices for reform” in the European Parliament, said The Investigative Desk in a press release.

Daan Marselis, Reporter for The Investigative Desk in Holland, and lead author of the BMJ report

The European Commission and the European Medicines Agency declined to comment on the findings until the European Commission’s official report is published, said Daan Marselis from The Investigative Desk, and lead author of the BMJ report, to Health Policy Watch.

Currently, EU legislation makes it “impossible” to withdraw or shorten the ten year market exclusivity once it has been granted to a pharmaceutical company, even if unfair prices are spotted in time by regulatory authorities, said The Investigative Desk in a press release.

Another problem is that companies can apply for multiple “orphan indications” on the same medicine to successfully extend their market protection period beyond ten years, said Marselis to Health Policy Watch. Since 2001, 14 drugs have enjoyed fifteen or even twenty years of market exclusivity, according to The Investigative Desk’s research.

Since 2001, 14 orphan drugs have enjoyed more than ten years of market exclusivity

Orphan Drugs Are More Profitable Than Ever, But 95% Of Rare Diseases Are Still Untreated

Orphan drugs have become five times more profitable in past decades, as annual sales revenues have ballooned from €133 million in 2001 to €723 million in 2019, according to the Holland-based investigative group. Rare cancer drugs are the most lucrative, with an average turnover of € 1.1 billion, or twice as much as other orphan drugs that do not treat cancer.

Although orphan drugs are becoming more profitable, 95% of rare diseases are still untreatable, said the EU-commissioned review. Meanwhile, over two thirds of the 146 orphan drugs introduced in 2001-2016 in Europe were developed for diseases that are already treatable. 

In other words, most rare diseases are still untreatable, and the majority of drugs are developed for rare diseases that are already treatable.  

 “Over time, the [EU orphan drug] Regulation seems to have become less effective in directing research to areas where there are no treatments: only 28% of the 142 authorised orphan medicines targeted diseases for which there were no alternative treatment option (95% of rare diseases remain still without a treatment)”, said the review.

Image Credits: WHO, BMJ, Daan Marselis.

Vitamin D supplements

People who tested positive for COVID-19 had lower Vitamin D levels on average than people who tested negative, according to a massive peer-reviewed Israeli study published in the FEBS Journal.

The study found that the average plasma Vitamin D level – or the level of vitamin D in the liquid part of the blood – was 19.00 nanograms per mililitre (ng/mL) in 782 individuals that tested positive for COVID-19, compared to an average of 20.55 ng/mL in 7,025 individuals who tested negative for the virus. The study was conducted on a cohort of patients who were part of Leumit Health Services.

However, some experts urge caution in reading too much into the study’s findings, saying that other factors may explain the relationship observed in the study.

Still, low plasma Vitamin D was associated with a higher risk of COVID-19 infection and hospitalization, even after taking preexisting conditions, socioeconomic status, age, and gender into account, according to the study. In COVID-19 patients who were hospitalized, the average plasma vitamin D level was even lower at 178.38 ng/mL.

Vitamin D could act like a steroid, study author Milana Frenkel-Morgenstern of Bar Ilan University told the Times of Israel. Some steroids, such as dexamethasone, have been shown in clinical studies to improve outcomes for patients facing more serious COVID-19 disease.

Frenkel-Morganstern encouraged the government to maintain adequate outdoor spaces so that people could get sunlight, which is absorbed through the skin and helps the body make Vitamin D. The vitamin has been associated with a wide variety of health benefits, including maintaining bones and regulating calcium levels in the body.

However, others have said that it is too early to tell whether Vitamin D actually reduces the risk of COVID-19 infection. For example, people who get more exercise could have higher Vitamin D levels, and it could ultimately be exercise that is impacting COVID-19 risk, according to Ella Sklan, head of a molecular virology lab at Tel Aviv University.

And proving whether Vitamin D has any benefits as a potential treatment against COVID-19 requires clinical trials. The World Health Organization did not comment on whether Vitamin D would be considered a candidate for its massive Solidarity clinical trials testing potential COVID-19 treatments at the time of publication.

However, maintaining a healthy diet, and supplementing diets with appropriate vitamins is a “positive way to keep oneself healthy,”  and keeping healthy allows the body to help fight infectious diseases, according to a WHO statement.

“In situations where individuals’ vitamin D status is already marginal or where foods rich in vitamin D (including vitamin D-fortified foods) are not consumed, and exposure to sunlight is limited, a vitamin D supplement in doses of the recommended nutrient intakes (200-600 IU, depending on age) or according to national guidelines may be considered,” added the statement.

This story was updated 30 July to include the WHO’s statement

 

Image Credits: Flickr: Filip Patock.

First in a series of stories about how the coronavirus lockdowns and relaxations are playing out in different parts of Africa. 

A middle-aged man sells cloth face masks and face shields along a major highway in Ibadan southwest Nigeria. Photo by Paul Adepoju/Health Policy Watch

Ibadan, Nigeria – While Lagos and Abuja capital city continue to be the epicenter of the COVID-19 pandemic in Nigeria accounting for nearly half of confirmed cases, Oyo State is also generating a buzz. The state, just north of Lagos, has the third highest case count, and infections are steadily rising, even as lockdowns are relaxed more rapidly than elsewhere and students also return to school.  

This has triggered concerns that Oyo could become Nigeria’s Texas or Florida if public health policy measures aren’t followed carefully – right now they are not.  

The World Health Organisation (WHO), globally and regionally, have concluded that the COVID-19 pandemic may not end anytime soon and urged countries and governments across the world to safely reopen their economies without putting citizens, especially the vulnerable age groups to COVID-19. In Nigeria, the Oyo State capital city of Ibadan is emerging as one that is racing towards returning to normal, largely ahead of others.

It is the only state capital where students are already returning to school even as the number of cases continue to rise – about 1,000 cases away from clinging Nigeria’s second highest number of confirmed cases of COVID-19. 

But with a case fatality ratio of just 0.9%, the city’s leadership and a significant proportion of the general public consider the threat of COVID-19 not strong enough to halt students’ education, put families out of work or put the city’s life on hold.

Masks on Neck, Not the Face 

Friends and colleagues, Rabiu and Adeolu, sit on their motorcycles while waiting for passengers to transport to and from the market. When asked about their consciousness about COVID-19, they pointed to the face masks they wore, though improperly. Photo by Paul Adepoju/Health Policy Watch

As early as 6am, activities are already underway at the Agbeni market. Thousands of people roam the tightly packed streets of the market shopping for wares ranging from foodstuffs, building items and musical instruments to clothing and intimate apparel. The only evidence of the existence of the COVID-19 pandemic is an occasional sighting of individuals wearing masks – usually on the neck rather than the face as required by State health authorities – whose enforcement of the rules is even less evident than the masks.

Cases of COVID-19 in Nigeria, 29 July 2020

Although the city was never locked down, a 8pm- 6a.m. curfew was imposed from March 30 to June 20, as COVID-19 spread across west Africa and case counts in Nigeria went from just two confirmed cases on March 9 to 41,804 on July 28. In Ibadan, the first case of COVID-19 in the state was confirmed by the NCDC on March 21 and the case count rose to 2,668 on July 28.

The curfew had devastating impacts on the city’s nightlife and entertainment economy. Moreover, thousands of informal workers associated with this economy had their sole means of livelihood cut off abruptly – without the provision of  commensurate palliatives – unemployment, cash grants or even food aid. 

Just a few meters from the Oyo State Government Secretariat, activities have now been extended to 9pm at the popular Ultima Restaurant following the curfew’s relaxation.

The curfew had devastating impacts on the city’s nightlife and entertainment economy. Moreover, thousands of informal workers associated with this economy had their sole means of livelihood cut off abruptly – without the provision of  commensurate palliatives – unemployment, cash grants or even food aid. 

Just a few meters from the Oyo State Government Secretariat, activities have now been extended to 9pm at the popular Ultima Restaurant following the curfew’s relaxation.

During the curfew, a staff member told Health Policy Watch: “We had to suspend the evening shift which meant fewer workers; we also had to come to terms with the fact that we would have fewer customers. Although luckily for us we had our delivery service which saw increased adoption during the period.” 

Now, activities are returning to normal at the restaurant. Although a sign stating that only 10 people are allowed inside at any time is still at the entrance, customers are no longer asked to wait outside. Furthermore, instead of a handwashing station, the facility has shifted to temperature check and alcohol-based hand sanitizers. It has also been advising its customers to wear face masks – although not many adhere to the rule after gaining entry. 

A customer washes her hands before being allowed to enter a restaurant in Ibadan. Photo by Paul Adepoju/Health Policy Watch

“It will be easy for the city to move on if the people are abiding by guidelines that we are issuing, Ogunniyi Abiodun, public health expert at the Nigeria Center for Disease Control (NCDC), told Health Policy Watch. “Unfortunately, this is not happening as we would have loved it to be, which is why the number of cases continues to rise. But we will continue to appeal to the people and the government to base their decisions on the best available evidence.”

The Booming Business of COVID-19

Innovation has been at the heart of the COVID-19 response in the city as individuals and organisations embrace and deploy solutions that best suit their needs and are also within their budgets.

Not too far away from Ultima, a Domino’s Pizza outlet on Osuntokun avenue is co-located with an ice cream franchise. Together they have deployed a custom-built handwashing station that has a tap that users do not even have to touch – thus providing some form of protection against contracting the virus by touching frequently touched surfaces.

The hand washing station at Domino’s Pizza outlet located at Bodija area in Ibadan, southwest Nigeria. Photo by Paul Adepoju/Health Policy Watch

Social Distancing Not an Option

But most small and medium scale entrepreneurs in Ibadan lack the luxury of space enjoyed by franchise chains like Dominos – and therefore cannot effectively implement hygiene or social distancing measures. 

One of the popular landmarks in Ibadan is the Cocoa House at the center of Ibadan’s Dugbe Business District. Completed in 1965 at a height of 105 metres and was once the tallest building in tropical Africa. Opposite the historic building is a line of small shops being used by small business owners. In one of them, Tijani Balogun and four other phone repairmen are attending to customers with damaged mobile devices – a brisk business even in hard times. 

In the small room that is just about one-meter wide, customers watch as their mobile devices are disassembled and damaged parts are replaced. While admitting that the threat posed by COVID-19 to both customers and artisans is imminent, Tijani said it is a risk worth taking considering there is no better option.

“I don’t see any option for us to make daily living and maintain social distancing. Five of us are even struggling to keep up with the annual rent fee. Are we going to say that only one of us should use the shop each day?” he asked.

Presented with the shop serving as a potential petri dish for COVID-19, Tijani said customers without face masks cannot be denied services because of his competitors next door that will gladly welcome them.

“I’m not sure if I will get it (COVID-19) or not but I’m sure that I can die of hunger if I don’t attend to my customers that will pay me and give me money to feed myself and my family,” he said.

Phone repair technicians working together in a small shop in the Dugbe area of Ibadan attend to customers without wearing face masks. Photo by Paul Adepoju/Health Policy Watch

Government Plans Stricter Enforcement of Mask Rules  

Inasmuch as establishments are being compelled to have measures in place to protect workers and visitors, individuals are also expected to prioritise wearing of face masks and are aware that they could be denied entry to public places if they don’t have one on. But a loophole has also emerged – presenting a face mask at the door and removing it after gaining entry.

A cross section of defaulters that spoke to Health Policy Watch in Ibadan metropolis described the wearing of masks as necessary but uncomfortable when they wanted to talk or in need of fresh air.

“Even when I’m the only one in my car, they would not allow me to enter public premises without having a face mask on. So I just have to hang it for them to see and remove it afterwards,” Abiodun Ilori, a civil service worker said.

An overview of COVID-19 response in Ibadan suggests that more enforcement and a clearer attribution of responsibilities would be required to improve the outcomes of current efforts. 

Currently most of the onus for compliance rests on business outlets that can be shut down or receive hefty fines if they contravene government’s guidelines. 

So in general, stores, restaurants and workplaces that can afford to take measures, are attempting to comply with requirements, at least with regards to social distancing and hygiene. But since citizens themselves face no direct repercussions if they fail to wear masks or observe hygiene and distancing rules, abiding with directives has still remained largely optional. 

At a KFC outlet in Ibadan, only one person out of four wore the face mask properly. Photo by Paul Adepoju/Health Policy Watch

Realising this, the state government recently announced that from August 2020, it would start arresting and prosecuting residents caught not wearing masks in public. During the weeks leading up to the commencement of the enforcement measures, the government said it will attempt to “sensitize, persuade and ensure compliance”. 

A similar enforcement approach is being deployed in Lagos which is about 120 kilometers away from Ibadan and is the epicenter of Nigeria’s COVID-19 pandemic. 

Health System Tested by COVID-19

Beyond the enforcement of prevention measures, access to COVID-19 tests is also expanding – although efforts to strengthen the diagnostic capacity have also put health systems to the test.

Even though access to testing is still unequal, community testing is expanding as volunteers are being mobilised from one part of the city to another including open markets. 

More and more health clinics  serving local communities are also opening test collection centres.  And there are ventures to expand testing in non-traditional sites too. For instance, the state government-owned Lekan Salami Stadium at Adamasingba in Ibadan has recently opened a testing center, under a public-private partnership with health tech startup lifebank, Nigeria Institute for Medical Research, Citizen for Citizen (an NGO) and laboratories at University of Ibadan’s College of Medicine.

The state government-owned Lekan Salami Stadium at Adamasingba in Ibadan is also being used as a COVID-19 testing centre. Photo by Paul Adepoju/Health Policy Watch

Prior to COVID-19, the major responsibilities of hospitals under the state’s healthcare system included care of patients living HIV, malaria, maternal health and immunization. With the advent of COVID-19, existing health infrastructures are being converted to aid the response – as has happened in countries elsewhere. 

A newly constructed maternity hospital at Olodo area of Ibadan became the state’s largest COVID-19 isolation centre while the Chest Clinic at Jericho area of the city, which was the hub of tuberculosis diagnosis and treatment prior to the pandemic, was also converted into another isolation center. 

Itunu Adelowo, Director of Operations at the African Development and Empowerment Foundation described the roles being played by the state’s health system as evidence of the need for much bigger investments in, and empowerment of, health systems. 

“When we say invest in ending maternity mortality, COVID-19 has shown that the acquired capacity for fighting maternal mortality could be deployed in tackling health emergencies. As poor as the health system was before COVID-19, it remains a major pillar supporting COVID-19 response. Now imagine what can be achieved when we have a well funded, structured and enabled health infrastructure,” Adelowo told Health Policy Watch. 

“It will be easy for the city to move on if the people are abiding by guidelines that we are issuing, Ogunniyi Abiodun, public health expert at the Nigeria Center for Disease Control (NCDC), told Health Policy Watch. “Unfortunately, this is not happening as we would have loved it to be, which is why the number of cases continues to rise. But we will continue to appeal to the people and the government to base their decisions on the best available evidence.”

Life goes on in a second hand clothes market in Ibadan – Photo by Paul Adepoju/Health Policy Watch

Image Credits: P Adepoju/HP-Watch, Nigeria Centres for Disease Control.

Head of the Italian Medicines Agency Luca Li Bassi at 72nd World Health Assembly, where he led approval of a historic resolution on price transparency in medicines markets.

Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette.

The decree, following on from last year’s milestone World Health Assembly resolution on transparency of markets for health products, represents a “very important” step towards enabling government authorities to negotiate more effectively with the private sector over new drug prices, Luca Li Bassi, former Director-General of the Italian Medicines Agency (AIFA), told Health Policy Watch.

“The Decree is a very good step forward that addresses the asymmetry of information at the negotiating table with the private sector”, said Li Bassi, who was also the leading architect, on behalf of the Italian Government, of the WHA transparency resolution from 2019. “Having information is vital when you’re negotiating, otherwise you’re negotiating blindly.”

Luca Li Bassi holds his transparency award

The decree was actually approved by Italy’s Ministers of Health and Finance in August 2019.  But after a government reshuffle in the fall, it languished in limbo due to a technicality – as it had not been published in the official Italian government gazette.  Last Friday, it finally surfaced, observers say at an opportune moment as Italy’s badly hit health system recovers from the first wave of the pandemic. COVID-19 has also churned up further debate over issues of drug access, pricing and transparency  – as pharma companies and countries scramble to research and acquire technologies that could better treat the viral disease.

“For a COVID-19 pandemic response to be effective and legitimate, it is critical to ensure that transparency is upheld, particularly when it comes to clinical trials, pricing and supply schemes,” said Jaume Vidal, Senior Policy Advisor of Health Action International, to Health Policy Watch. “The decree clearly shows that the need for greater transparency on medicine prices and R&D costs is still in the agenda more than a year after the historic Italy-led WHA resolution was approved.”

According to Li Bassi, the decree will strengthen AIFA’s negotiating position with pharmaceutical companies as they seek reimbursement for their innovations. It will provide public health authorities not only with data about contributions public sources may have made to the R&D of a new drug, but also about sales revenue, marketing costs and the status of relevant patents. The new regulations also require pharmaceutical companies to submit information to AIFA about reimbursement prices in other countries. That would provide Italian government authorities with a means to compare reimbursements, and thus prices, for the same health products across countries. 

“Most importantly, this decree enables AIFA to make a far better informed analysis of the reimbursements demands made by suppliers, resulting in a significantly transformed negotiation process across the table”.

The decree is also a “very important step” that could encourage other countries to follow in the same direction, and for more collaboration to spearhead the transparency agenda in the future, said Li Bassi: 

“Anything that can be done to enhance transparency in the biopharmaceutical sector is definitely going to be useful.”

Image Credits: Twitter/@Italy_UNGeneva, l'Observatoire Médicaments Transparences.

Vaccination can effectively prevent mother-to-child transmission of hepatitis B

In a landmark achievement, incidence of chronic hepatitis B has successfully dropped below 1% in children under five, reaching the 2020 goal set at the 2016 World Health Assembly, said World Health Organization Director-General Dr. Tedros Adhanon Ghebreyesus on Monday.

The target reduction in hepatitis B virus (HBV) incidence in children was met in 2019, a rare case where global health goals were achieved within the intended timeline. The achievement, announced just ahead of World Hepatitis Day, provides a much-needed boost of morale for the embattled global health community in the wake of this year’s pandemic and its knock-on effects on other disease areas. 

“HBV has been a scourge in many countries for so many decades”, said WHO’s Head of Health Emergencies Mike Ryan. “To see incidence [of hepatitis B] less than 1% in children is just incredible”

“I know it doesn’t sound like it, but we should take these successes because they’re true victories for global health.”

The reductions in HBV incidence in children were largely thanks to the wide deployment of a childhood vaccine against the virus. 

Still, Dr Tedros warned that countries must stay on guard.

Disruption of essential services, like vaccination against Hepatitis B, could result in five million additional chronic hepatitis B (HBV) infections in children born between 2020 and 2030, as well as one million additional HBV-related deaths among those children later on, according to a study by Imperial College London and WHO which has not been published yet. 

Additionally, the hepatitis death toll could skyrocket because of coronavirus-related disruptions, warned Dr. Tedros. Hepatitis infections can cause liver damage and liver cancer, and currently claim 1.3 million lives a year. 

Globally, about 325 million people live with hepatitis B and C, the most deadly of the five types of hepatitis disease.

Hepatitis B Vaccine Coverage Threatened During Coronavirus Pandemic
A healthcare worker in Lao PDR provides the first dose of the hepatitis B vaccine, given within 24 hours of birth.

As a result of the pandemic, disruption of essential hepatitis services, like HBV vaccination of infants, threatens to claim thousands of additional lives, added panelists at the WHO briefing.

“Even in the midst of the COVID-19 pandemic, we must ensure that mothers and their babies have access to life-saving services including hepatitis B vaccinations. Preventing transmission of hepatitis B from mother-to-child and in early childhood is the most important strategy for controlling the disease and saving lives”, said Dr. Tedros.

Mother-to-child transmission is responsible for the brunt of new HBV infections, and the virus claims nearly 900,000 lives each year. Boosting vaccine coverage is particularly important in WHO’s African Region, where HBV vaccine coverage at birth is ten times lower than the global average of 42%.

“For regions such as sub-Saharan Africa with low access to the vaccine, increasing coverage of a timely birth dose is the priority,” emphasized Doherty.

Some countries have successfully maintained essential services for other infectious diseases like measles despite the pandemic, suggesting the same could be done for HBV. Ethiopia, for instance, has successfully vaccinated almost 15 million children against measles during the pandemic, according to a report from WHO’s African region on Monday.

The HBV vaccine can protect against the virus in more than 95% of cases, and has been proven to be safe after nearly four decades of use.

WHO Issues New Hepatitis Guidelines To Prevent Mother-to-Newborn Transmission

On Monday, Dr. Tedros also called on countries to implement two new recommendations to prevent onward transmission of HBV from pregnant women to their newborns.

As part of the new guidance, pregnant women that are HBV-positive and present a high viral load can protect their newborns through preventive antiviral therapy from the 28th week of pregnancy until birth.

The antiviral of choice, tenofovir, only costs $3 per month in many regions of the world.

However, in settings where viral load testing is unavailable, women are encouraged to use the low-cost “HBeAg” antigen test to assess their infection status, recommends the WHO.

Battle Against Hepatitis C Continues Amidst High Medicines Costs and Barriers To Diagnosis
Meg Doherty, WHO’s Director of Global HIV, Hepatitis and STI Programmes

In recent years, so-called “direct acting antivirals” have also prevented thousands of deaths from hepatitis C (HCV) for as little as $60 in some regions, Meg Doherty, WHO’s Director of Global HIV, Hepatitis and STI Programmes, said on Monday. A typical treatment course on these drugs is twelve weeks.

However, these lifesaving drugs are still out of reach for many patients in high- and middle-income countries, where a twelve-week treatment course can even climb to $3000 given the absence of special licenses with generic companies to produce the drugs at a cheaper price, Doherty told Health Policy Watch.

“Not all countries will have access to the [cheaper] generics, though more and more countries have access now [over 105 countries] to some of the direct acting antivirals.”

She also added that without access to testing, “the medicines will remain out of reach”, as she referred to the fact that only 19% of HCV patients (13.1 million) are diagnosed with HCV, and only 7% of people with HCV (5 million) are treated for the disease, according to WHO data from 2017.

People waiting to receive free hepatitis C
testing during World Hepatitis Day 2016, Rwanda

Image Credits: WHO, Flickr: CDC Global, WHO, WHO.