New Delhi: India’s apex drug regulator is collating information on adverse events due to medical devices to take timely action against manufacturers and ensure appropriate measures to mitigate risks to public health as the number of such incidents rise.

The Drugs Controller of General of India has issued a prescribed format to collect information on undesired effects from medical devices and in-vitro-medical devices (IVDs), ensuring that the identity of the ‘patient’ or the ‘complainant’ will not be made public. The proforma has to be filled with details such as description of the medical device with details including the brand name, manufacturer, importer or distributor. 

The DCGI has urged people to send the duly filled form to the Indian Pharmacopoeia Commission, a body under the health ministry, which runs the government’s Materiovigilance Programme of India (MvPI) platform to monitor adverse events associated with medical devices in India.

The regulatory action is aimed at stricter surveillance of side effects from medical devices, a market that is estimated to expand from $11 billion to $50 billion by 2030. Mint earlier reported about DCGI directing all medical device licence holders and manufacturers to report any adverse events related to life-saving medical equipment on the MvPI platform.

Safety concerns

Unlike drugs, absolute safety in medical devices—which are engineering, not chemical, products — may not be possible, according to said Rajiv Nath , forum coordinator, AiMeD, an umbrella body of medical device manufacturers in India.

There needs to be post marketing surveillance of serious adverse events that lead to death or injuries requiring surgical intervention, he said. What’s important that such events have to be reported to manufacturers to enable faster and direct redressal or the Indian Pharmacopoeia Commission or the regulator, using the feedback for systemic reviews, he said.

Medical devices are therapeutic, diagnostic, therapeutic & diagnostic, implantable, non-implantable, invasive & non-invasive, single-use device, reusable, sterile & non-sterile, and for personal use and homecare.

Nath said the reports on adverse events from such devices should not result in witch-hunting and a trust factor needs to be created to persecute the one reporting—whether it’s a health care provider or patient or the manufacturer itself.

Lack of clarity

DCGI, in its public notice, said the submission of a Medical Devices Adverse Event (MDAE) does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the adverse event and also “does not have any legal implication on the reporter”.

 “The patient/reporter’s identity is held in strict confidence and protected to the fullest extent. Programme staff is not expected to and will not disclose the patient/reporter’s identity in response to a request from the public,” it said.

Citing regulations in the US and the European Union, Nath also stressed on clarity for “what’s reportable and what’s not—what’s a serious adverse event and what’s a non-serious adverse event”.

“Currently there’s a lot of confusion and lack of clarity at various levels, so either there’s under-reporting or an extreme of over reporting at some organizations or not reporting to manufacturer but reporting to regulators,” he said. “Webinars and public education will help to bring clarity and build a trust factor.”

New Delhi: India has the highest number of oral cancer cases among countries in South Asia, driven by increased use of smokeless tobacco products like betel quid with tobacco, gutka, khaini; and areca nut, according to a study on Wednesday. 

The study led by the International Agency for Research on Cancer (IARC) and published in The Lancet Oncology journal showed that India logged 83,400 of the 120,200 oral cancer cases globally caused by smokeless tobacco (chewed, sucked, inhaled, applied locally, or ingested) and areca nut (seed of the areca palm) in 2022.

The consumption of areca nut (30 per cent) and betel quid with tobacco (28 per cent) were responsible for the most oral cancer cases among women, followed by gutka (21 per cent) and khaini (21 per cent).

Among men, it was khaini (47 per cent), gutka (43 per cent), betel quid with tobacco (33 per cent), and areca nut (32 per cent).

“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” said Dr Harriet Rumgay, a scientist in the Cancer Surveillance Branch at IARC.

“We found that more than 120,000 people across the world were diagnosed with oral cancer that could have been caused by using smokeless tobacco or areca nut. Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nuts,” he added.

The IARC study showed that 120,200 of the 389,800 oral cancer cases in 2022 could be caused by smokeless tobacco and areca nut use. This also means that by preventing smokeless tobacco and areca nut use, one-third (31 per cent) of all oral cancer cases could be avoided.

Further, more than 95 per cent of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries (115,900 cases).

India was followed by Bangladesh (9,700), Pakistan (8,900), China (3,200), Myanmar (1,600), Sri Lanka (1,300), Indonesia (990), and Thailand (785).

While “control of tobacco smoking has improved, prevention of smokeless tobacco use has stalled, and areca nut remains largely unregulated,” said Dr. Isabelle Soerjomataram, Deputy Head of the Cancer Surveillance Branch at IARC.

The study called for prioritising smokeless tobacco control, and developing a framework for areca nut prevention which must be integrated into cancer control programmes.

CNN
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Scientists in Germany say they’ve been able to make a nasal vaccine that can shut down a Covid-19 infection in the nose and throat, where the virus gets its first foothold in the body.

In experiments in hamsters, two doses of the vaccine – which is made with a live but weakened form of the coronavirus that causes Covid-19 – blocked the virus from copying itself in the animals’ upper airways, achieving “sterilizing immunity” and preventing illness, a long-sought goal of the pandemic.

Although this vaccine has several more hurdles to clear before it gets to a doctor’s office or drug store, other nasal vaccines are in use or are nearing the finish line in clinical trials.

China and India both rolled out vaccines given through the nasal tissues last fall, though it’s not clear how well they may be working. Studies on the effectiveness of these vaccines have yet to be published, leaving much of the world to wonder whether this approach to protection really works in people.

The US has reached something of a stalemate with Covid-19. Even with the darkest days of the pandemic behind us, hundreds of Americans are still dying daily as the infection continues to simmer in the background of our return to normal life.

As long as the virus continues to spread among people and animals, there’s always the potential for it mutate into a more contagious or more damaging version of itself. And while Covid infections have become manageable for most healthy people, they may still pose a danger to vulnerable groups such as the elderly and immunocompromised.

Researchers hope next-generation Covid-19 vaccines, which aim to shut down the virus before it ever gets a chance to make us sick and ultimately prevent the spread of infection, could make our newest resident respiratory infection less of a threat.

One way scientists are trying to do that is by boosting mucosal immunity, beefing up immune defenses in the tissues that line the upper airways, right where the virus would land and begin to infect our cells.

It’s a bit like stationing firefighters underneath the smoke alarm in your house, says study author Emanuel Wyler, a scientist at the Max Delbruck Center for Molecular Medicine in the Helmholtz Association in Berlin.

The immunity that’s created by shots works throughout the body, but it resides primarily in the blood. That means it may take longer to mount a response.

“If they are already on site, they can immediately eliminate the fire, but if they’re like 2 miles away, they first need to drive there, and by that time, one-third of the house is already in full flames,” Wyler said.

Mucosal vaccines are also better at priming a different kind of first responder than injections do. They do a better job of summoning IgA antibodies, which have four arms to grab onto invaders instead of the two arms that the y-shaped IgG antibodies have. Some scientists think IgA antibodies may be less picky about their targets than IgG antibodies, which makes them better equipped to deal with new variants.

The new nasal vaccine takes a new approach to a very old idea: weakening a virus so it’s no longer a threat and then giving it to people so their immune systems can learn to recognize and fight it off. The first vaccines using this approach date to the 1870s, against anthrax and rabies. Back then, scientists weakened the agents they were using with heat and chemicals.

The researchers manipulated the genetic material in the virus to make it harder for cells to translate. This technique, called codon pair deoptimization, hobbles the virus so it can be shown to the immune system without making the body sick.

“You could imagine reading a text … and every letter is a different font, or every letter is a different size, then the text is much harder to read. And this is basically what we do in codon pair deoptimization,” Wyler said.

In the hamster studies, which were published Monday in the journal Nature Microbiology, two doses of the live but weakened nasal vaccine created a much stronger immune response than either two doses of an mRNA-based vaccine or one that uses an adenovirus to ferry the vaccine instructions into cells.

The researchers think the live weakened vaccine probably worked better because it closely mimics the process of a natural infection.

The nasal vaccine also previews the entire coronavirus for the body, not just its spike proteins like current Covid-19 vaccines do, so the hamsters were able to make immune weapons against a wider range of targets.

As promising as all this sounds, vaccine experts say caution is warranted. This vaccine still has to pass more tests before it’s ready for use, but they say the results look encouraging.

“They did a very nice job. This is obviously a competent and thoughtful team that did this work, and impressive in the scope of what they did. Now it just needs to be repeated,” perhaps in primates and certainly in humans before it can be widely used, said Dr. Greg Poland, who designs vaccines at the Mayo Clinic. He was not involved in the new research.

The study began in 2021, before the Omicron variant was around, so the vaccine tested in these experiments was made with the original strain of the coronavirus. In the experiments, when they infected animals with Omicron, the live but weakened nasal vaccine still performed better than the others, but its ability to neutralize the virus was diminished. Researchers think it will need an update.

It also needs to be tested in humans, and Wyler says they’re working on that. The scientists have partnered with a Swiss company called RocketVax to start phase I clinical trials.

Other vaccines are further along, but the progress has been “slow and halting,” Poland said. Groups working on these vaccines are struggling to raise the steep costs of getting a new vaccine to market, and they’re doing it in a setting where people tend to think the vaccine race has been won and done.

In reality, Poland said, we’re far from that. All it would take is another Omicron-level shift in the evolution of the virus, and we could be back at square one, with no effective tools against the coronavirus.

“That’s foolish. We should be developing a pan-coronavirus vaccine that does induce mucosal immunity and that is long-lived,” he said.

At least four nasal vaccines for Covid-19 have reached late-stage testing in people, according to the World Health Organization’s vaccine tracker.

The nasal vaccines in use in China and India rely on harmless adenoviruses to ferry their instructions into cells, although effectiveness data for these has not been published.

Two other nasal vaccines are finishing human studies.

One, a recombinant vaccine that can be produced cheaply in chicken eggs, the same way many flu vaccines are, is being put through its paces by researchers at Mount Sinai in New York City.

Another, like the German vaccine, uses a live but weakened version of the virus. It’s being developed by a company called Codagenix. Results of those studies, which were carried out in South America and Africa, may come later this year.

The German team says it’s eagerly watching for the Codagenix data.

“They will be very important in order to know where whether this kind of attempt is basically promising or not,” Wyler said.

They have reason to worry. Respiratory infections have proved to be tough targets for inhaled vaccines.

FluMist, a live but weakened form of the flu virus, works reasonably well in children but doesn’t help adults as much. The reason is thought to be that adults already have immune memory for the flu, and when the virus is injected into the nose, the vaccine mostly boosts what’s already there.

Still, some of the most potent vaccines such as the vaccine against measles, mumps and rubella use live attenuated viruses, so it’s a promising approach.

Another consideration is that live vaccines can’t be taken by everyone. People with very compromised immunity are often cautioned against using live vaccines because even these very weakened viruses may be risky for them.

“Although it’s strongly attenuated, it’s still a real virus,” Wyler said, so it would have to be used carefully.

CNN
 — 

Air pollution spiked to unhealthy levels around the world in 2021, according to a new report.

The report by IQAir, a company that tracks global air quality, found that average annual air pollution in every country — and 97% of cities — exceeded the World Health Organization’s air quality guidelines, which were designed to help governments craft regulations to protect public health.

Only 222 cities of the 6,475 analyzed had average air quality that met WHO’s standard. Three territories were found to have met WHO guidelines: the French territory of New Caledonia and the United States territories of Puerto Rico and the US Virgin Islands.

India, Pakistan and Bangladesh were among the countries with the worst air pollution, exceeding the guidelines by at least 10 times.

The Scandinavian countries, Australia, Canada, Japan and United Kingdom ranked among the best countries for air quality, with average levels that exceeded the guidelines by 1 to 2 times.

In the United States, IQAir found air pollution exceeded WHO guidelines by 2 to 3 times in 2021.

“This report underscores the need for governments around the world to help reduce global air pollution,” Glory Dolphin Hammes, CEO of IQAir North America, told CNN. “(Fine particulate matter) kills far too many people every year and governments need to set more stringent air quality national standards and explore better foreign policies that promote better air quality.”

Above: IQAir analyzed average annual air quality for more than 6,000 cities and categorized them from best air quality, in blue (Meets WHO PM2.5 guildline) to worst, in purple (Exceeds WHO PM2.5 guideline by over 10 times). An interactive map is available from IQAir.

It’s the first major global air quality report based on WHO’s new annual air pollution guidelines, which were updated in September 2021. The new guidelines halved the acceptable concentration of fine particulate matter — or PM 2.5 — from 10 down to 5 micrograms per cubic meter.

PM 2.5 is the tiniest pollutant yet also among the most dangerous. When inhaled, it travels deep into lung tissue where it can enter the bloodstream. It comes from sources like the burning of fossil fuels, dust storms and wildfires, and has been linked to a number of health threats including asthma, heart disease and other respiratory illnesses.

Millions of people die each year from air quality issues. In 2016, around 4.2 million premature deaths were associated with fine particulate matter, according to WHO. If the 2021 guidelines had been applied that year, WHO found there could have been nearly 3.3 million fewer pollution-related deaths.

IQAir analyzed pollution-monitoring stations in 6,475 cities across 117 countries, regions and territories.

In the US, air pollution spiked in 2021 compared to 2020. Out of the more than 2,400 US cities analyzed, Los Angeles air remained the most polluted, despite seeing a 6% decrease compared to 2020. Atlanta and Minneapolis saw significant increases in pollution, the report showed.

“The (United States’) reliance on fossil fuels, increasing severity of wildfires as well as varying enforcement of the Clean Air Act from administration to administration have all added to U.S. air pollution,” the authors wrote.

Researchers say the main sources of pollution in the US were fossil fuel-powered transportation, energy production and wildfires, which wreak havoc on the country’s most vulnerable and marginalized communities.

“We are heavily dependent on fossil fuels, especially in terms of transportation,” said Hammes, who lives a few miles from Los Angeles. “We can act smartly on this with zero emissions, but we’re still not doing it. And this is having a devastating impact on the air pollution that we’re seeing in major cities.”

Climate change-fueled wildfires played a significant role in reducing air quality in the US in 2021. The authors pointed to a number of fires that led to hazardous air pollution — including the Caldor and Dixie fires in California, as well as the Bootleg Fire in Oregon, which wafted smoke all the way to the East Coast in July.

China — which is among the countries with the worst air pollution — showed improved air quality in 2021. More than half of the Chinese cities analyzed in the report saw lower levels of air pollution compared to the previous year. The capital city of Beijing continued a five-year trend of improved air quality, according to the report, due to a policy-driven drawdown of polluting industries in the city.

The report also found that the Amazon Rainforest, which had acted as the world’s major defender against the climate crisis, emitted more carbon dioxide than it absorbed last year. Deforestation and wildfires have threatened the critical ecosystem, polluted the air and contributed to climate change.

“This is all a part of the formula that will lead to or is leading to global warming.” Hammes said.

The report also unveiled some inequalities: Monitoring stations remain scant in some developing countries in Africa, South America and the Middle East, resulting in a dearth of air quality data in those regions.

“When you don’t have that data, you’re really in the dark,” Hammes said.

Hammes noted the African country of Chad was included in the report for the first time, due to an improvement in its monitoring network. IQAir found the country’s air pollution was the second-highest in the world last year, behind Bangladesh.

Tarik Benmarhnia, a climate change epidemiologist at Scripps Institution of Oceanography who has studied the health impact of wildfire smoke, also noted that relying only on monitoring stations can lead to blind spots in these reports.

“I think it is great that they relied on different networks and not only governmental sources,” Benmarhnia, who was not involved in this report, told CNN. “However, many regions do not have enough stations and alternative techniques exist.”

The UN Intergovernmental Panel on Climate Change concluded in its 2021 report that, in addition to slowing the speed of global warming, curbing the use of fossil fuels would have the added benefit of improving air quality and public health.

Hammes said the IQAir report is even more reason for the world to wean off fossil fuel.

“We’ve got the report, we can read it, we can internalize it and really devote ourselves to taking action,” she said. “There needs to be a major move towards renewable energy. We need to take drastic action in order to reverse the tide of global warming; otherwise, the impact and the train that we’re on (would be) irreversible.”

CNN
 — 

Fresh off the back of a stunning victory in the 70th Anniversary Grand Prix at Silverstone, Red Bull driver Max Verstappen has said that while he appreciates being compared to F1 great Michael Schumacher, he is his own man.

The 22-year-old was recently likened to Schumacher by F1 managing director Ross Brawn in his formula1.com column.

“He reminds me of Michael Schumacher in many ways,” said Brawn of the Dutchman, before adding: “I remember Max’s early days in Formula 1 where his speed was clear – he has now matured into an exceptional racing driver.”

Speaking to CNN’s Amanda Davies, Verstappen said: “It was of course very nice but I don’t like to compare myself to anyone because I’m myself and I’m a different driver.

“Of course, you can always get some similar attitudes or whatever, or you can get compared sometimes but, from my side, I never do that. I just want to be myself.”

Aged 17 and 166 days, Verstappen became the youngest driver in F1 history when he competed in the 2015 Australian Grand Prix. Over the years he has, he said, matured as a driver.

“[I’m] more relaxed, more consistent and know how to build up a weekend and stuff like that,” he added.

“I just feel very comfortable … I’m a very relaxed person anyway so, for me, it was never really super high pressure, but I am more relaxed in a way that I know what’s coming.

“I have experienced a lot already so going to a weekend, I mean, I’m excited to be racing, but I don’t get excited a lot by other stuff surrounding it because you’ve experienced so many different emotions throughout the whole weekend and the year.”

The Dutch driver’s victory at Silverstone was the ninth of his career, but crossing the finishing line still excites him.

“Winning is a good one,” he said. “A good qualifying lap might excite me. Just being around the team and working with the mechanics, and also when they pull off a really good pitstop, it’s a great feeling as well.”

Verstappen finished ahead of Mercedes duo Lewis Hamilton and Valterri Bottas in sweltering conditions last Sunday.

Heading into this weekend’s Spanish Grand Prix, Verstappen is second in the standings for the drivers’ championship – 30 points behind world champion Hamilton.

But such has been the dominance of Mercedes so far during this 13-race season – the team leads second-place Red Bull in the constructor standings by 67 points – the Red Bull driver did not expect to be mounting a title challenge in the remaining eight races.

“So far we’ve had one race where we were, maybe, the fastest car, but all the other ones we weren’t, so we just have to stay realistic at the moment,” said Verstappen, speaking from Barcelona.

“From my side, I’m not thinking about a possible championship at the moment. I just want to try and do the best I can every single weekend.”

READ: Susie Wolff says Lewis Hamilton’s criticism of F1 is ‘absolutely valid’

The 2020 F1 season began in July at the Austrian Grand Prix, four months later than planned because of the coronavirus pandemic.

Since the restart drivers have joined F1’s “We Race As One” initiative to fight racism and promote equality and inclusion.

But Verstappen is one of several drivers to choose not to kneel before races in support of the Black Lives Matter movement.

Posting on Twitter before the first race, he said: “I am very committed to equality and the fight against racism. But I believe everyone has the right to express themself (sic) at a time and in a way that suits them. I will not take the knee today but respect and support the personal choices every driver makes.”

Hamilton, the sport’s first and only Black world champion in its 70-year history, has been critical of the sport, saying there has been a lack of leadership in the fight against racism.

Five races into the season, Verstappen said that while the campaign is going well, more needed to be done.

“It’s gone well in terms of how we are expressing it but, of course, at the end of the day it’s about actions as well. We just keep showing our support, because I think everybody is in support, which is very important, and time will tell of course what’s going to happen,” he said.

Asked about whether he and the other drivers have spoken to Hamilton regarding the campaign, Verstappen said: “Of course we talk about it. We have our driver briefings but then also we stay on, of course, because we are all members of the GPDA (Grand Prix Drivers’ Association).

“Everybody’s very open and everybody is very supportive and everybody wants exactly the same thing. I think Lewis appreciates that, and it’s not only Lewis who has to appreciate that, it’s the whole world. That’s what we are doing, we are just trying to show our support.”