In the unprecedented race to develop a COVID-19 vaccine, the World Health Organization says that there are no “cutting corners” in testing the safety and efficacy of a new vaccine candidate.

Vaccine development has moved at an unprecedented pace. In six months, some 26 candidates are already undergoing human testing, while 139 more are in preclinical trials, according to WHO’s COVID-19 vaccine tracker. Russia recently announced its intention to approve a Russian vaccine by August 10, although they have not released any safety and efficacy data to the public nor to WHO.

Following the Russian announcement, more concerns have been exprssed that vaccine developers may be making compromises in safety and efficacy studies for speed.

Six other vaccine candidates, not including the Russian vaccine candidate,  are already in Phase III clinical tests, the last stage of mass testing in humans according to WHO’s tracker. This crucial phase of testing helps determine whether the vaccine candidate can truly protect against COVID-19 infection, COVID-19 disease, or severe illness.

But a senior WHO official expressed confidence on Thursday that safety corners are not being cut, despite the speed at which R&D is taking place. Results from preliminary trials of all other six vaccine candidates, not including the Russian one, have been submitted to WHO’s vaccine tracker and are being monitored by the organization.

“This is about accelerating the process of development, putting the risk on the financial side of the equation, not on the safety side of the equation, and ensuring that there’s enough [vaccine] production to meet the needs around the world,” said WHO Health Emergencies Executive Director Mike Ryan at the Apsen Security Conference.

But even after a vaccine is approved and deployed widely, Ryan said, scientists will continue monitoring safety and efficacy signals.

“We will still have to remain cautious as we scale up the number of people vaccinated. Rare side effects…only become apparent when you vaccinate lots and lots of people. So there will still be a need for a monitoring phase, even when we start to vaccinate a population level,” said Ryan.

“There are no cutting corners here,” he warned.

Many Unknowns With Russia’s Vaccine Candidate

Ryan’s comments come a week after Russia announced its intention to approve a vaccine candidate developed by the Moscow-based Gamaleya Institute, by August 10th, and begin mass immunizations by October 2020, according to CNN. Russia has the fourth highest number of coronavirus cases in the world, reporting over 870,000 cumulative cases.

Meanwhile, in a race that has taken on some of the feeling of a Cold War-era rivalry, the United States has said it expects a vaccine only to be approved at the earliest by the end of 2020 or beginning of 2021. The United States’ epidemic has dwarfed other countries’ outbreaks with more than 4.8 million cumulative cases reported.

China, the original epicentre of the world’s outbreak, has already approved a vaccine candidate for military use, although experts remain concerned about the efficacy of the vaccine, and Phase III tests are still ongoing.

Cumulative cases of COVID-19 as of 6:37PM CET 6 Aug 2020. Numbers change rapidly.

“It’s another Sputnik moment,” Kirill Dmitriev, head of Russia’s sovereign wealth fund, the financier behind the Russian vaccine, told CNN. Dmitriev was referring to the Soviet Union’s first ever successful satellite launch, ahead of the United States’ launch in the infamous ‘Space Race’ of the 20th century. “Americans were surprised when they heard Sputnik’s beeping. It’s the same with this vaccine. Russia will have got there first.”

But Russia’s vaccine is not one of the six that WHO has been monitoring in clinical trials. And the Organization has said that so far, they have not received any information on the effectiveness and safety of the vaccine from Russia’s trials. Critics have been concerned that the vaccine has not yet undergone enough testing to verify its safety and effectiveness.

Human Challenge Studies Can Be Justified, But May Not Be Required For Testing COVID-19 Vaccines

Speaking at the Aspen event, Ryan also said that human challenge studies, in which individuals in a vaccine trial are purposely inoculated with the virus to test a vaccine candidate’s efficacy, are not necessarily required in the context of COVID-19.

Normal final phase clinical trials draw their conclusions by enrolling massive numbers of people, under the assumption that enough participants will be naturally exposed to the infectious agent to test the vaccine’s efficacy. The large sample size allows scientists to tease out conclusions that could be missed in smaller trials; but these trials can take more time to carry out.

As a result, some experts, including a Harvard bioethicist, have proposed that carefully designed, smaller human challenge studies may be the fastest way to test a vaccine candidate’s efficacy.

Ryan said that a WHO committee is considering the implications of human challenge studies, examining parameters to conduct them in a safe and ethical manner.

“Obviously, we do not fully understand the long term consequences of natural infection, even in younger adults, and we will have to be very careful for instituting human challenge studies,” he said. “They will have to be very carefully assessed for their ethics and the potential health effects. But there are certainly circumstances in which such trials can be justified.”

However, he added that since COVID-19 has become so widespread, larger-scale trials of the traditional kind can be completed within a relatively short time-frame.

“[Human challenge studies are] usually done when there’s very low level of human disease, and therefore it’s difficult to demonstrate efficacy,” explained Ryan. “In this case we have disease, all over the world so we should be able to demonstrate efficacy of the vaccine in the traditional way by large-scale population based trials.”

 

Image Credits: Johns Hopkins CSSE.

Existing smog tower stands in the Lajpat Nagar neighborhood of south-east Delhi.

Environmentalists and scientists have called out the recent Indian Supreme Court decision directing the government to install “smog towers” in Delhi as an injudicious move that will lead to a waste of public money.

The opposition escalated after the Court on Tuesday, ordered the government to begin installing the smog towers within the next week.

Critics compare the use of the expensive and untested technology, that claims to suck up air pollutants produced by vehicles, industry and other sources, with the installation of outdoor air-conditioners to cool down global warming.

“Assuming that we can vacuum away our outdoor air pollution problem is not only a waste of tax-payers money, but also highly unscientific. If there is one lesson to learn from the COVID lockdowns, then it is the fact that we can clean our air and our act only by controlling the emissions from all the sources,” says Sarath Guttikunda, director of Urban Emissions, an air pollution information, research and analysis repository.

Even assuming 100% efficiency at all times, any outdoor smog tower can purify only 0.00007233796% of the total volume of air in the city’s 6,400 square kilometer airshed every hour, through which some 5.76 billion cubic meters of air pass every hour, contends Guttikunda.  In comparison, preventing emissions at sources such as a cement or coal-fired plant would prevent nearly 100% of emissions. He also notes that the technology was tested and failed during the 2010 Commonwealth Games in Delhi.

Smog Towers Are Cost-Ineffective Technologies
Smog obscures buildings in the distance in Gurgaon Cyber City, in Delhi

Due to the sharp limits of the technology, smog towers are ultimately far less cost-effective, in comparison to actually reducing emissions at source. At present air pollution levels, Delhi would need at least 2.5 million such smog towers to clean its air, according to one analysis carried out by Council on Energy, Environment and Water (CEEW). The city requires more sustainable solutions, as citizens in the capital inhaled dangerously toxic air for 241 days in 2019, the analysis adds.

“In no way should such unproven technologies be encouraged,’ says Tanushree Ganguly, a programme associate at CEEW, adding that money being spent on these smog towers could be used for proven measures, such as: ensuring coal power plants that generate significant air pollution comply with emission norms, ensuring a clean and reliable mass transit system, and improving waste management, to halt incineration.

“In addition to rejecting the smog tower as a solution, we should demand for evidence of its impact (or lack of it) through all our writings on this subject. We could ask for evidence on the Lajpat Nagar smog tower’s impact, the smog guns that are being used. If these are indeed solutions, then where is the evidence of the impact? Where is the data, the clear metrics to assess performance?” asks Ganguly.

“Limited resources available for air pollution action should be used for reducing emissions at source rather than testing technologies that are unproven to be effective,’ adds urban air quality scientist Pallavi Pant.

Smog Towers Haven’t Worked in China
Smog (left) obscures view of Tiananmen Square (right) in Beijing, China.

Other critics point to China, which has long experimented with smog towers many times larger than the smog tower currently in use in Delhi at Lajpat Nagar, without any documented success.

“Smog towers just end up as visible showpieces which are easier to sell as solutions to gullible ordinary citizens. When public money is scarce, especially during a pandemic, this is surely no time to experiment with untested technologies. To tackle air pollution, curbing emissions must be the top priority.” says Mihir Shah, strategic communications lead, CEEW.

“The general theme of these studies is that there are slight to modest AQ benefits in the very close vicinity of these very large towers. That is rather damning when taken in the broader perspective: a colossal misallocation of resources that will never scale,” says Joshua Apte, who holds a joint appointment at the University of California at Berkeley’s School of Public Health and Civil/Environmental engineering department.

While slamming the misallocation of resources, environmentalists also are wondering what led to the sudden enthusiasm among decision-makers for the smog towers. They say that the move will merely delay what are urgently needed measures, such as the stricter enforcement of existing laws, greater focus on renewables, less dependance on fossil fuels and more focus on health harm caused by dirty air.

“When the bucket is overflowing and your house is flooded, you don’t go looking for a mop, you turn off the tap. The only solution to pollution is to stop pumping pollutants in the air. Smog towers are a criminal waste of money and anyone with basic common sense can see that,” says Brikesh Singh of the Clean Air Collective, an unbranded collective of over 100 think-tanks, researchers and activist groups.

‘It is necessary to have enough proof to show that smog towers are an effective solution for air pollution before they start them installing them across the country,” says Meghna Amin, campaigner at Jhatkaa. Jhatkaa, an Indian NGO that builds grassroots citizen power, has been running a campaign against smog towers since March 2020, giving the science and rationale behind it.

“We are unable to understand why the government and the courts are repeatedly rejecting the opinions of environmentalists and experts who have clearly stated that smog towers are ineffective in outdoor settings. The only effective way to tackle PM2.5 is to eradicate it at its source. Any other solution is just a waste of tax payers money,” Amin adds.

Supreme Court Has Played Activist Role in Smog Tower Installation

The Court’s original order on the towers was issued in January, after two months in which Delhi reached some of the highest winter air pollution levels ever recorded, prompting public outcry. With government failing to effectively mount policies, the court began to play a more activist role in the desperate quest for solutions to clean the city’s toxic air.

The Court asked the central and Delhi governments to set up a panel to explore the feasibility of various emergency measures. Smog towers was one of the recommendations made at the time – although the panel, whose members were never publicly identified, only recommended setting up a ‘pilot” to ‘see how it fares.’  A joint proposal by the Indian Institute of Technology-Bombay, IIT- Delhi and the University of Minnesota, which had been pending with the Central Pollution Control Board, was then pulled out of the drawers.

As soon as talk of installation of smog towers became public, our air pollution advocacy non-profit Care for Air wrote an open letter to the Supreme Court, requesting it to not promote “band-aid fixes” like smog towers and other outdoor air-purifiers to deal with north India’s debilitating winter smog. At the same time, campaigning for Delhi state’s Legislative Assembly elections was getting into high gear, and the main political parties and their candidates were promising to clean the city’s polluted air.  For the first time that pollution came up as a poll agenda, following a  parliamentary debate on the subject, also a first.

While skies cleared visibly in the spring during the COVID-19 pandemic lockdown, the smog season of late fall and winter is now looming. Late fall and early winter are times when urban emissions from sources such as heating increase substantially, while weather conditions leave pollutants lingering in the city’s air. Crop burning in neighboring regions adds to the toxic mix.  Last year the pollution darkened the city’s skies for weeks on end, with 24-hour air pollution levels 10-20 times above WHO air quality recommendations.

On July 21, the Court ordered the national government, as well as Delhi state authorities, to accelerate its actions to install smog towers in Delhi.  Last week, the Court gave the government one week for the project – to be funded by public money – to begin.  On Tuesday, the government informed the Court that it had finally entered into an agreement with IIT-B, to supervise a project to install smog towers in Delhi.

The Supreme Court of India

While the Court moves may be seen by some as a valiant attempt to make some progress on cleaning Delhi’s toxic air ahead of the next crisis, analysts say the Court has overlooked the science that says that the technology only works within enclosed spaces, and has failed in other countries.

The Court, however, has largely ignored the outcry, calling out the Ministry of Environment, Forest and Climate Change and the Delhi government, over and over, giving them fresh deadlines to comply with its direction on installing smog towers in the capital city.

“We are shocked at the attitude of the respondents with respect to installation of smog towers, which were supposed to be installed within three months and for which an agreement was to be entered into and the order was passed on 13 January after obtaining the requisite reports,” the Court said in July.

In a hearing on 29 July, when IIT-Bombay displayed reservations about going ahead with the project in Delhi, a furious Supreme Court Justice Arun Mishra sternly rebuked the engineering institution, saying the court would “punish” it for withdrawing from a government project. Justice Misra even threatened contempt proceedings, saying “I can’t tolerate this nonsense.”

Environmentalists retweeted this exchange, questioning why the court was pressing this so urgently when science doesn’t back smog towers being of any use in reducing outdoor air pollution.

Air Pollution Finally a National, Political Issue
Smog in Delhi

On the more positive side, the debate has also helped thrust air pollution into the forefront of national debate – even at a time when Delhi skies have been unusually clean and blue, due to the COVID-19 imposed lockdown that reduced the city’s noxious fumes from sources such as traffic, industry and construction.

Air pollution kills nearly seven million people worldwide each year, according to the WHO’s estimates. Some 91% of those premature deaths occur 4 in low- and middle-income countries, and the greatest number in the WHO South-East Asia and Western Pacific regions.

Delhi is among the most polluted cities in the world. In May 2014, the WHO’s list of cities suffering high air pollution levels had identified New Delhi as the worst in its 1,600-city worldwide database.

Increasingly aware of the health damage that air pollution is wreaking, voters across the city and social classes have begun to demand clean air as a social and human right. But the mounting political pressure has also led to quick fix solutions, such as the smog towers. Others include “smog guns” and “vacuum cleaners” to clean outdoor air.

However, as Randeep Guleria, director of the All India Institute of Medical Sciences, New Delhi, recently said, such technologies belittle the problem on the one hand and on the other, raise false hopes among those affected by air pollution.

Existing Tower Doesn’t Work
Smog towers have not been able to reduce levels of PM2.5 particles within their vicinity.

In early January, the Gautam Gambhir Foundation installed a ‘smog tower’ in Lajpat Nagar, costing ₹7 lakh (US $9300), according to media reports. Global air pollution experts say it is not helping reduce pollution by even marginal amounts – even in its immediate vicinity.

Five experts, including scientists associated with Care for Air, visited the tower within the first three weeks of its inauguration on January 3 and found that PM2.5 some distance away from the tower was lower than PM2.5 close to the tower.

“I did a video shoot near the tower for 3 hours. There was absolutely no reduction in PM levels next to this smog tower and within a 150m radius on 3 different angles,” says Barun Aggarwal, CEO of clean air consultancy firm Breathe Easy Consultants, who visited the site on January 10 with his industry calibrated DustTrak monitor- an instrument used to accurately measure particulate matter concentrations. “I saw a man standing there with a local handheld meter taking readings. I found out he works for the company that made the tower, but he seemed completely clueless about how to take readings.”, says Aggarwal.

Things were worse three days later, on January 13, when atmospheric scientists and researchers Bhargav Krishna and Apte visited the tower. Its inbuilt monitor measured PM at 636, as photographed and tweeted by Krishna and Apte. Their photos and tweets also showed that some of the filters were already damaged and air wasn’t reaching the bottom outlets. On January 31, when Tanushree Ganguly who works on air pollution section at the Council on Energy, Environment and Water, visited the tower, it wasn’t working.

Similarly, China’s giant smog-sucking tower installed in 2016 was found to be inefficient by the China Forum of Environmental Journalists after a 50-day trial. Smog-free towers called WAYU, developed and installed by IIT and National Environmental Engineering Research Institute (NEERI) in Delhi in 2018, ended up as dustbins due to their ineffectiveness.

Smog Towers Give False Sense Of Complacency

Ultimately, observers say, installations such as smog towers provide the public with a false sense of complacency and assurance. At this point in a national pandemic where winter 2020 could lead to high levels of air pollution that compounds the impacts of the mounting incidence of respiratory infections from COVID-19, we need strong actions that yield a real and significant reduction in PM2.5 levels.

Already in February, Finance minister Nirmala Sitharaman allocated ₹4,400 crore (US$ 600 million) towards clean air in this year’s national budget, as per the recommendations of the 15th Finance Commission. The national finance commission is also considering the creation of longer-term performance based grants for India’s cities and local authorities over the coming five years. These funds should be targeted towards reducing emissions at source through improved industrial filters, faster transition to renewable energy, improved public transportation and the shutdown of old thermal power plants that do not meet emission standards – rather than expensive and unproven smog towers.

____________________________________________

Jyoti Pande Lavakare is the co-founder of Care for Air India. She is an independent journalist focusing on environmental health issues, and a former financial and business reporter for Dow Jones Newswires, The Business Standard and India Ink. her first book, “Breathing Here is Injurious To Your Health” is due to be published by Hachette in 2020.

Image Credits: Care for Air India, Flickr: Ninara, Flickr: James Riker, Wikimedia Commons: Legaleagle86, Flickr: Ninara, Jyoti Pande Lavakare.

Parents hold their child, who suffers from spinal muscular atrophy.

European legislation on drugs for rare diseases is “far from perfect”, but it is not a ‘failure’ given the amount of private sector investment it has attracted in the past two decades, says Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe, a non-profit alliance of some 930 rare disease patient organisations across 72 countries, in an interview with Health Policy Watch. 

He was responding to a report published in The BMJ last week by a Dutch group of investigative journalists that said European orphan drug regulations have “failed” to incentivize R&D for rare diseases. The report also said the regulations, which offer new orphan drugs ten years of “market exclusivity”, had created a ‘corporate cash machine’ allowing biopharmaceuticals to reap ‘billions’ in profits. 

The investigative report largely based on an interim European Commission review, also notes that two thirds of orphan drugs have been developed for diseases that are already treatable – implying that most orphan drug investment is redundant.

Cam, however, said the report’s conclusions are simplistic, ignoring the big achievements that have been made since the regulations were put in place two decades ago.

“Twenty years ago, pulmonary arterial hypertension used to be fatal. Today, 7 treatments are approved in Europe, largely because of EU and US orphan drug regulations. The life of patients has changed,” he said. 

He said that the deeper problem is the lack of collaborative action among European member states on the orphan drug front, particularly in post-marketing research into the long-term benefits of newly approved drugs, which can further define their long-term value – and thus market price potential.  

The investigative report also claims that only 18-24 of the 142 orphan drugs that had been approved between 1999 and 2017 were developed as a result of the EU Orphan Regulation. However, there is “no data” to back up this “opinion”, said Le Cam.

Le Cam also added that 50% of orphan products in the EU market (65) can be sold as generic treatments because their ten-year period of market exclusivity has run out – according to an internal analysis by EURORDIS, which has not been published.

The Investigative Desk’s Analysis Is ‘Rigorous’, But Some Interpretations Are Misleading  

Although The BMJ analysis is rigorous, some of its interpretations are misleading because they suggest that rare disease R&D is redundant, among other issues, said Le Cam.

“Over time, the [EU orphan drug] regulation seems to have become less effective in directing research to areas where there are no treatments….95% of rare diseases remain still without a treatment”, said the interim version of the European Commission review.

Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe

However, that ignores the fact that new treatments which have been approved often target the most prevalent diseases, said Le Cam. And rare disease prevalence can differ by a factor of 3,000. For instance, cystic fibrosis affects about 30,000 people in Europe, while some rare immune-deficiencies only affect 10 newborns a year.

“When you look at the numbers, it’s true that 95% of rare diseases are not treatable. What’s usually not mentioned is that two-thirds of orphan drugs developed so far treat the 400 most prevalent diseases. Deriving estimates from data can offer useful starting points, but they can also be misleading.”

The 95% figure is also an underestimate of the real unmet medical needs, as “very few” existing treatments are curative. For most rare diseases – such as hemophilia, cystic fibrosis, or seizure disorders – people are still living with a “dreadful disease”.

Finally, he notes that the conclusions of the BMJ investigative report are largely based on an interim version of the European Commission review,to be published in final form only later this summer. Until then, the underlying data upon which the report was based isn’t really available.  

“The BMJ article doesn’t provide any analysis or rational ground to claim that EU Orphan Regulations failed. They refer to a report by the European Commission which is not yet published, hence we don’t know how this number was derived. This is not a fact or a demonstrated analysis, it is a mere opinion,” he said. 

Rare diseases are defined as ones that affect less than 5 in every 10,000 people. It is estimated that at least 30 million people in the EU are affected by a rare disease.

European Incentives Have Provided Value – However Market Exclusivity Invites Misuse Of The Rules

Ellen ‘t Hoen, Director of Medicines, Law & Policy and a long-standing advocate of strong medicines access policies, offers a rather nuanced view of The BMJ report’s conclusions – and on Europe’s incentive schemes. 

“The number of orphan drugs registered has risen sharply in 20 years thanks to European incentive schemes. However, the market exclusivity for 10 years leads to high prices and invites ‘drug pirates’ to misuse the rules,” she told Health Policy Watch, referring to a recent article she co-authored and published in the Dutch medical journal.

“I recognise that there is a need for incentives to develop orphan drugs – but the current regulation is in need of urgent revision,” she added, pointing to a Briefing Document by Medicines, Law & Policy published last year, which concluded that while the EU regulations had been abused, its ‘incentives have undoubtedly contributed to a huge increase in the level of engagement of pharmaceutical firms with orphan diseases, which has led to many new orphan medicinal products being introduced to the European market’.

Now, however, “the time has come to critically evaluate the EU Orphan Drug Regulation for effectiveness and to develop new innovation models for diseases for which the pharmaceutical industry is not showing interest,” said ‘t Hoen. “The European Commission and the Member States urgently need to take measures to stop improper use of the Orphan Medicinal Products Regulation.” 

She said she was awaiting the full report by the European Commission to see what remedies it recommends. 

“The [European] Commission commissioned a study of the orphan drug regulation and has it at its disposal – for some time now but has not made the study public. Word on the street is that it is forthcoming. This study is carried out by Technopolis and addresses the effectiveness of the regulation. It will be important to know the conclusions and recommendations made by the researchers. The study is part of the pharmaceutical incentives review the Council asked for in 2016.”

Importantly, EU Regulation needs to have a “corrective mechanism for misbehaviour”, emphasized Hoen, who received a royal prize for her work on access to medicines a few months ago. 

Among the recommendations made by her NGO a year ago, would be the introduction of a so-called ‘‘sufficiency test’, which would shorten the ten year period of market exclusivity if sufficient return on investment is proven for a given orphan drug.

According to recent data, a ten-year period of market exclusivity has been granted in 99.96% of orphan drugs in the EU based on the so-called ‘prevalence threshold’, which assumes that investment in diseases affecting less than five in ten thousand people is not profitable. This assumption is needing ‘urgent revision’, said ‘t Hoen.

European Collaboration To Drive Down Prices Of Orphan Drugs  

Child with Williams syndrome in Russia

Le Cam agrees that in some cases, a ten-year period of market exclusivity or more is excessive given the rewards the drugs may bring.

But he stresses that more European collaboration not only on R&D but also with respect to price negotiations, would help improve access and lower prices of many orphan drugs, referring to the findings of a 2018 EURODIS analysis.

If Member States were to collaborate more closely on post-marketing R&D, they would be better positioned to negotiate drug prices, as well as agreements to ensure access to drugs in smaller countries and specific demographic groups. 

He explains that in the case of many orphan drugs, treatments are “stabilizing” rather than “curative”. And given the small numbers of patients involved, post-market evaluation of the real value of new rare disease treatments is critical. It can also ensure that treatments cater to the broad range of clinical symptoms reported by patients with rare diseases – a highly heterogeneous group. 

“Today, data collected in the region is not robust enough to allow different treatments to be compared between each other and to determine which product is the most suitable for which age, in which situation, in which combination and which regimen”, said Le Cam. “Pooling data across Europe with the same research questions and protocols would be good science and better use of your money.”

“We can blame the private sector as this report does, but we also need to blame member states for their fragmented approach to generating evidence on orphan drugs after they’re approved. As a result, we still don’t know the real-life value of treatments in patients and are unable to adjust prices accordingly.”

Given that some patients fail to respond to specific treatments, having several drugs for the same disease up our sleeves is crucial – and it can also drive down their price due to competition. Developing such data would also enable orphan drugs to be priced more fairly, as their cost would reflect their ‘real-life value in patients’.

Le Cam also added that European member states tend to negotiate orphan drug prices on an individual basis rather than on a regional level, leaving smaller nations – such as Denmark, Belgium of the Netherlands – standing in the queue for “years” until they gain access, although the same treatment may be available in a larger country right next door.

In 2017, about a quarter of Europeans with a rare disease said their treatment had not been available in their country over the previous year, according to a EURORDIS survey co-funded by the EU.

A Structured & Collaborative Approach To Price Negotiations 

In 2018, EURORDIS urged member states to jointly negotiate a ‘European Transactional Price’ for orphan drugs to account for the fact that preliminary treatments are still ‘‘approximates” rather than ‘curative’ treatments. The Paris-based NGO also called on countries to collaboratively generate robust value assessments for orphan drugs – thus empowering the region to renegotiate the Transactional Price in a way that it reflects the value of the treatment provided. 

The mechanisms proposed by EURORDIS would reduce fragmentation of the European market and allow patients to have immediate access to lifesaving drugs while reducing prices, Le Cam says.

“Offering immediate access to patients and predictability of revenue will attract private sector investment, while also reducing prices and expanding getting access to patients.”

The industry is ready to compromise prices in return for better access to patients and market predictability, he said. However, Member States have acted as the main bottleneck in past decades, and must collaborate for better price negotiation and access.

Today, collaboration is limited to a handful of initiatives, but “the intent is there”. These include the so-called ‘BeNeLuxA’ initiative from 2015, where Belgium, the Netherlands, Luxembourg, Austria, and Ireland came together to kick start negotiations for medicines, including orphan drugs.

More recently in 2017, other member states – Malta, Romania, Greece, Cyprus, Italy, Spain, Portugal and Ireland – agreed to jointly negotiate orphan drug prices in the Valletta Declaration, which covers some 160 million Europeans, or about 32% of the EU’s population.

In 2017, ten European Member States signed the Valletta Declaration to improve access to medicines, including orphan drugs

The General Consensus – ‘Urgent’ Action Is Needed

Despite lively debates over The BMJ investigative report, there seems to be a growing  consensus that both the European Commission and Member States need to take urgent measures to improve access to patients with rare diseases.

The debates over medicines access and pricing raised by COVID-19 may even help accelerate action on the rare disease front as well. 

Says Le Cam: “European Member States have never been able to put their act together because there was a lack of support from the European Commission that didn’t want to put their finger in supporting Member States to collaborate on price negotiation and access. Now, this is changing completely with COVID-19.” 

Image Credits: EURORDIS – Rare Diseases Europe, EURORDIS – Rare Diseases Europe, EURORDIS – Rare Diseases Europe, Valletta Technical Commitee.

Mothers should continue to breastfeed their children as the benefits of breastfeeding outweigh the risks of COVID-19 during the pandemic, said WHO Director General Dr Tedros Adhanom Ghebreyesus Monday, kicking off World Breastfeeding Week.

The risk of transmitting COVID-19 to via breastmilk is low, according to the World Health Organization. So far, there have been no confirmed cases of mother-to-child transmission of COVID-19 by breastfeeding.

Thus, “WHO recommends that mothers with suspected or confirmed COVID-19 should be encouraged, the same as all other mothers, to initiate or continue to breastfeed,” said Dr Tedros. “The many benefits of breastfeeding for newborn babies and children substantially outweigh the potential risks for COVID-19 infection.”

Breastmilk contains key nutrients and maternal antibodies, which protect the child against different diseases as their own immune system is developing. Antibodies with reactivity to the COVID-19 virus have been found in breastmilk, although it’s still unknown whether these protect children against infection. Breastfed children also have higher cognitive ability and lower risk of obesity.

The COVID-19 pandemic has brought to light fears that the virus could be transmitted through breastmilk. However, so far only one case of a breastfed infant testing positive for COVID-19 has been reported in studies, and it’s unclear whether the infant was infected via breastmilk, or through droplets from the infected mother.

According to WHO, children are at low risk of COVID-19 infection, and symptoms are typically mild. In light of all the evidence so far, WHO continues to recommend that mothers keep breastfeeding, regardless of infection status. 

Image Credits: WHO.

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.