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Ethical drugs, unethical practices

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by Geewananda Gunawardana, Ph.D.

Ensuring the quality, safety, and efficacy of pharmaceuticals requires a high level of constant vigilance. A good example is the four deaths caused by contaminated eye drops in the USA last May despite the well-regulated and best prepared monitoring of the drug supply by the US Food and Drug Administration. Unfortunately, the consumers in places where regulations as well as their implementations fall short of ideals can fall victims much more frequently: A World health Organization (WHO) report finds that about 10% of the world’s drug supply is either subpar or fake. Global deaths among children alone due to subpar drugs is over 150 thousand annually while the economic cost is estimated to be about US $ 200 billion.

While loss of life is a tragedy, the failure to ensure the quality of medicinal products can have far reaching and long-lasting consequences of much larger magnitude. The emergence of drug resistant infections and parasitic diseases and genetic disorders due to subpar drugs will only come to light in the long run.

To get some idea about the vulnerability of pharmaceuticals, it is important to know the way the regulatory process works. Almost 90% of the new drug development takes place in North America and Europe. The rest is divided among Japan and Israel. India and China, leaders in generic drug manufacture, are only beginning to enter this field through collaboration with American and European pharmaceutical companies. When a drug is invented, the inventor obtains a patent, which is an exclusive right to market it for 20 years. However, a patent only keeps the competition away, and it does not give the authority to market the drug, which must be obtained from the regulatory agency of the respective country.

To get the marketing authority, a vast amount of data must be produced showing efficacy, safety, and manufacturability of the drug. This process takes 10 to 12 years on average and over US $ 1.5 billion in R&D costs. As the development takes up to 8 to 10 years, the actual patent life left when it goes to market is reduced to 10 to 12 years, during which time the company must recoup all the costs and make a profit. A drug marketed under patent is known as a brand name drug. These initial R&D costs make the brand name drugs expensive.

The manufacturer of the brand name drug must follow all the current good manufacturing practices (cGMP) as specified by the regulatory agency of the marketed countries. The International Conference on Harmonisation (ICH) has standardised these guidelines and are followed by the major pharmaceutical manufacturing countries. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.

The consequences of failing to meet guidance can be harsh. For example, the UK based Glaxo Smith Kline was fined US$ 3 billion in 2012, the highest in history for cGMP violations. The brand name drug manufacturers avoid taking any risks as the stakes are very high. There are some companies that were forced to shut down for failing to follow cGMP. A common problem with brand name drugs is the manufacture of counterfeit drugs sold in small markets despite the best efforts of the patent owner to avoid such piracy. The commitment to quality and the stringent regulatory vigilance makes brand name drugs less susceptible for quality issues.

Once the patent expires, anyone with the right capabilities can manufacture the drug and seek marketing authorisation in selected countries. These drugs are referred to as generic drugs. Since the generic manufacturers do not have to bear the billion-dollar R&D costs, they can afford to lower the price. The competition for market share also drastically reduces the cost of generic drugs, often by over 80% of the original price. The costs can be further reduced by moving the manufacturing into places where the labor and operating costs are lower and occupational safety and environmental regulations are lax or lacking altogether. The affordability and wide availability are the beneficial outcomes of generic drugs. For example, 91% of the drugs prescribed in the USA in 2022 were generic drugs. Except for a rare event, the US drug supply remains safe and reliable, mainly thanks to the diligence of the US Food and Drug Administration.

The bulk of these cost-effective generic drugs are destined for low- and middle-income countries. Unfortunately, that is where the troubles begin. The WHO has formulated international regulatory standards to ensure the safety and efficacy of the drugs in places where ICH guidance is not implemented. They also have a program for pre-qualification of drug manufacturing facilities when requested. While international organisations require WHO prequalification for drug purchases, individual governments can follow their own regulations. Knowing the presence of potential buyers who are willing to forgo cGMP requirements, some manufacturers tend to ignore the need for costly qualification or certification programms. This practice is also encouraged by the premise on the buyers’ side that testing alone can ensure the quality of drugs. However, the truth is that failing to follow cGMP can lead to unintended release of subpar drugs to markets even if the standard testing procedures are followed.

Two processes where this can happen easily are sterilisation and achieving content uniformity. Failure to ensure that every single unit of the drug, be it a pill or a vial of many thousands manufactured, is compliant could result in subpar drugs reaching the market. In the case of uneven sterilisation, microbial contamination can occur as was seen with eye drops. Failure to ensure uniformity can result in drug units containing either higher or lower doses than shown on the label.

Most of the generic drugs are manufactured in Asia. Drug manufacturing is a multistep process conducted in multiple locations under varying levels of regulatory control. A routine drug manufacture can have the following basic steps: procurement of raw materials, synthesis of starting materials and/or intermediates, synthesis of the active pharmaceutical ingredient (API), procurement of excipients, and formulation of the API into the drug product – capsule, tablet, syrup etc. This can vary for biologics such as vaccines and recombinant proteins etc., which make up only about 2% of all drugs used. In either case, at every step, the product must be stored in proper containers under the right conditions as determined based on its stability to prevent degradation and contamination.

Except for biologics, almost all drugs are produced by chemical synthesis. A small portion are either plant or microbial origin. The generic drug manufacturers come up with alternate synthetic routes that are cost effective. This creates a major problem: Any synthetic process generates impurities or side products in addition to the desired product. These impurities could have unknown properties, including toxicity, and must be removed or kept to a minimum using various purification steps. The processes and analytical methods used for this purpose by the brand name manufacturer are optimized to monitor and control any impurities specific to the raw materials, starting materials, and excipients they used. However, if the generic manufacturers introduce any changes, the standard quality control methods may not work, and undesired impurities will end up in the drug causing potential adverse events. Another potential problem, particularly in the warm and humid tropics, is microbial contamination, as happened with eye drops when handling and storage conditions are deviated.

With complicated supply chains, it is very difficult for the drug purchaser to track if all processes used in the manufacture of the drug were conducted under cGMP. Either they do not have the wherewithal or have no impetus altogether as happens when questionable drug procurement methods are followed. There are other ways the purity of drugs can be compromised. All drugs have a limited lifetime as specified by the expiration date. The expiration date is set assuming the storage of the drug under certain conditions and in designated containers. Any deviation, which can happen easily when transported between tropical locations, the drug can degrade reducing the potency or efficacy and introducing impurities. Without proper cGMP, it is not possible to know if such deviations have occurred.

If the drug is degraded, the desired therapeutic effect may not be achieved. In addition to that, in the case of antimicrobial and antiparasitic drugs, the administration of lower doses can lead to the development of drug resistant varieties. Infections caused by resistant organisms can be difficult, and sometimes impossible, to treat. Antimicrobial resistance is an urgent global public health threat that killed around 1.27 million people worldwide in 2019. If not controlled, this could render the current anti-infective drugs virtually useless and makes it one of the world’s most urgent public health problems.

The impurities or contaminants in drugs can have numerous undesired results including death. The deaths of 66 children in Gambia last year caused by taking contaminated cough syrup, imported from India, is just one example. A serious problem is contamination with genotoxic compounds. If not detected promptly, the consequences would not be known for many generations. The genotoxic impurities can be harmful when present in as low as parts per million amounts in the drug. The analytical techniques for detecting such low amounts require specific instruments not readily available in most laboratories. Recently, a whole family of hypertension drugs were found to contain genotoxic impurities and were withdrawn from the US markets.

These are the problems that can arise under normal operating procedures, and fortunately, the ones that can be eliminated if proper cGMP are observed. To worsen things, there are added problems that go beyond manufacture and cGMP. Unscrupulous drug companies and corrupt administrations contribute to the problem by knowingly allowing substandard drugs into healthcare systems with total disregard for life and limb. Pharmaceutical industry is notorious for its “gift” system for buying or prescribing their drugs. In one reported incident, a company sold 45 years’ worth of antibiotics to a developing country when the shelf life of the drug is only 2 years. Unloading drugs that are nearing expiration or not suitable for their own countries into low-income countries is a common practice.

The subpar drug related adverse events are predictable but also preventable. Generic drugs in general are safe and effective as international organizations have provided the means to ensure their safety and efficacy. Every step from the supply of starting materials to the dispensing of the drug to the patient must be controlled according to the guidance to receive the full benefits of drugs and avoid adversities. Sri Lanka has incorporated most of those rules and regulations to their own. However, their complete implementation remains questionable. Purchasing drugs without knowing its complete history is inviting trouble. Neglecting to do so puts future generations at risk in addition to wasting hard-earned foreign exchange.



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NASA’s Epic Flight, Trump’s Epic Fumble and Asian Dilemmas

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Epic Crew (L-R): Jeremy Hansen, Victor Glover, Reid Wiseman Christina and Christina Koch

Three hours after the spectacular Artemis II flight launch in Florida, US President Donald Trump delivered a forlorn speech from Washington. Thirty three days after starting the war against Iran as Epic Fury, the President demonstrated on national and global televisions the Epic Fumble he has made out of his Middle East ‘excursion’. It was an April Fool’s Day speech, 20 minutes of incoherent rambling with the President looking bored, confused, disengaged and dispirited. He left no one wiser about what will come next, let alone what he might do next.

There was more to April Fool’s Day this year in that it brought out the nation’s good, bad and the ugly, all in a day’s swoop. The good was the Artemis II flight carrying astronauts farther from the Earth’s orbit and closer to the moon for the first time in over 50 years. The mission is a precursor for future flights and will test the performance of a new spacecraft, gather new understanding of human conditioning, and extend the boundaries of lunar science. It is a testament to humankind being able to make steady progress in science and technology at one end of a hopelessly uneven world, while poverty, bigotry and belligerence simmer violently at the other end.

Terrible Trump

The four Artemis II astronauts, three Americans, Reid Wiseman, Victor Glover, and Christina Koch, and one Canadian, Jeremy Hansen, are also symptomatic of the endurance of America’s inclusive goodness in spite of efforts by the Trump Administration to snuff the nation’s fledgling DEI (Diversity, Equity and Inclusion) ethos. To wit, of the four astronauts, Victor Glover, a Caribbean American, is the first person of colour, Christina Koch the first woman, and Jeremy Hansen of Canada the first non-American – to fly this far beyond the earth’s orbit. All in spite of Trump’s watch.

Yet Trump managed to showcase his commitment to America’s ugliness, on the same day, by presenting himself at the Supreme Court hearing on the constitutionality of his most abominable Executive Order – to stop the American tradition of birthright citizenship. He keeps posting that America is Stupid in being the only country in the world that grants citizenship at birth to everyone born in America, regardless of the status of their parents, except the children of foreign diplomats or members of an occupying enemy force. In fact, there are 32 other countries in the world that grant birthright citizenship, a majority of them in the Americas indicating the continent’s history as a magnet for migrants ever since Christopher Columbus discovered it for the rest of the world.

And birthright citizenship in the US is enshrined in the constitution by the 14th Amendment, supplemented by subsequent legislation and reinforced by a century and a half of case law. Trump wants to reverse that. Thus far and no further was the message from the court at the hearing. A decision is expected in June and the legal betting is whether it would be a 7-2 or 8-1 rebuke for Trump. In a telling exchange during the hearing, when the government’s Solicitor General John Sauer quite sillily dramatized that “we’re in new world now … where eight billion people are one plane ride way from having a child who’s a US citizen,” Chief Justice John Roberts quietly dismissed him: “Well, it’s a new world. It’s the same Constitution!”

Trump’s terrible ‘bad’ is of course the war that he started in the Middle East and doesn’t know how to end it. Margaret MacMillan, acclaimed World War I historian and a great grand daughter of World War I British Prime Minister Lloyd George from Wales, has compared Trump’s current war to the origins of the First World War. Just as in 1914, small Serbia had pulled the bigger Russia into a war that was not in Russia’s interest, so too have Netanyahu and Israel have pulled Trump and America into the current war against Iran. World War I that started in August, 2014 was expected to be over before Christmas, but it went on till November, 2018. Weak leaders start wars, says MacMillan, but “they don’t have a clear idea of how they are going to end.”

There are also geopolitical and national-political differences between the 1910s and 2020s. America’s traditional allies have steadfastly refused to join Trump’s war. And Trump is under immense pressure at home not to extend the war. This is one American war that has been unpopular from day one. The cost of military operations at as high as two billion dollars a day is anathema to the people who are aggravated by rising prices directly because of the war. Trump’s own mental acuity and the abilities of his cabinet Secretaries are openly under question. There are swirling allegations of military contract profiteering and selective defense investments – one involving Secretary of War Pete Hegseth.

Trump’s Administration is coming apart with sharp internal divisions over the war and government paralysis on domestic matters. There are growing signs of disarray – with Trump firing his Attorney General for not being effective prosecuting his political enemies and Secretary Hegseth ordering early retirement for Army Chief of Staff Randy George. In America’s non-parliamentary presidential system, Trump is allowed to run his own forum where he lies daily without instant challenger or contradiction, and it is impossible to get rid of his government by that simple device called no confidence motion.

Asian Dilemmas

Howsoever the current will last or end, what is clear is that its economic consequences are not going to disappear soon. Iran’s choke on the Strait of Hormuz has affected not only the supply and prices of oil and natural gas but a family of other products from fertilizers to medicines to semiconductors. The barrel price of oil has risen from $70 before the war to over $100 now. After Trump’s speech on April 1, oil prices rose and stock prices fell. The higher prices have come to stay and even if they start going down they are not likely to go down to prewar levels.

There are warnings that with high prices, low growth and unemployment, the global economy is believed to be in for a stagflation shock like in the 1970s. Even if the war were to end sooner than a lot later, the economic setbacks will not be reversed easily or quickly. Supplies alone will take time to get back into routine, and it will even take longer time for production in the Gulf countries to get back to speed. Not only imports, but even export trading and exports to Middle East countries will be impacted. The future of South Asians employed in the Middle East is also at stake.

In 1980, President Carter floated the Carter Doctrine that the US would use military force to ensure the free flow of oil through the Strait of Hormuz. Trump is now upending that doctrine – first by misusing America’s military force against Iran and provoking the strait’s closure, and then claiming that keeping the strait open is not America’s business. Ever selfish and transactional, Trump’s argument is that America is now a net exporter of oil and is no longer dependent on Middle East oil.

To fill in the void, and perhaps responding to Trump’s call to “build up some delayed courage,” UK has hosted a virtual meeting of about 40 countries to discuss modalities for reopening the Strait of Hormuz. US was not one of them. While Downing Street has not released a full list of attendees, European countries, some Gulf countries, Canada, Australia, Japan and India reportedly attended the meeting. Which other Asian countries attended the meeting is not known.

British Foreign Secretary Yvette Cooper has blamed Iran for “hijacking” an international shipping route to “hold the global economy hostage,” while insisting that the British initiative is “not based on any other country’s priority or anything in terms of the US or other countries”. French President Emmanuel Macron now visiting South Korea has emphasized any resolution “can only be done in concert with Iran. So, first and foremost, there must be a ceasefire and a resumption of negotiations.”

Prior to the British initiative focussed on the Strait of Hormuz, Egypt, Pakistan and Türkiye have been playing a backdoor intermediary role to facilitate communications between the US and Iran. Trump as usual magnified this backroom channel as serious talks initiated by Iran’s ‘new regime’, and Trump’s claims were promptly rejected by Iran. There were speculations that Pakistan would host a direct meeting between US Vice President JD Vance and an Iranian representative in Islamabad. So far, only the foreign ministers of Egypt, Pakistan, Saudi Arabia and Türkiye have met in Islamabad, and Pakistan’s Foreign Minister Ishaq Dar flew to Beijing to brief his Chinese counterpart, Wang Yi, of Pakistan’s diplomatic efforts.

The Beijing visit produced a five-point initiative calling for a ceasefire, the opening of the Strait of Hormuz and diplomacy instead of escalation. The five-point pathway seems a follow up to the 15-point demand that the US sent to Iran through the three Samaritan intermediaries which Iran rejected as they did not include any of Iran’s priorities. The state of these mediating efforts are now unclear after President Trump’s April Fool’s Day rambling. In fairness, Pakistan’s Ministry of Foreign Affairs has announced that his country intends to keep ‘nudging’ the US and Iran towards resuming negotiations and ending the war.

While these efforts are welcome and deserve everyone’s best wishes, they have also led to what BBC has called the “chatter in Delhi” – “is India being sidelined” by Pakistan’s intermediary efforts? Indian Foreign Minister Jaishankar’s rather undiplomatic characterization of Pakistan’s role as “dalali” (brokerage) provoked immediate denunciation in Islamabad, while Indian opposition parties are blaming the Modi Government’s foreign policy stances as an “embarrassment” to India’s stature.

The larger view is that while it is Asia that is most impacted by the closure of Hormuz, with Singapore’s Foreign Affairs Minister Vivian Balakrishnan calling it an “Asian crisis”, Asia has no leverage in the matter and Asian countries have to make special arrangements with Iran to let their ships navigate through the Strait of Hormuz. There is no pathway for co-ordinated action. China is still significant but not consequentially effective. India’s all-alignment foreign policy has made it less significant and more vulnerable in the current crisis. And Pakistan has opened a third dimension to Asia’s dilemmas.

In the circumstances, it is fair to say that Sri Lanka is the most politically stable country among its South Asian neighbours. Put another way, Sri Lanka has a remarkably consensual and uncontentious government in comparison to the old governments in India and Pakistan, and even the new government in Bangladesh. But that may not be saying much unless the NPP government proves itself to be sufficiently competent, and uses the political stability and the general goodwill it is still enjoying, to put the country’s economic department in order. More on that later.

by Rajan Philips

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Ranjith Siyambalapitiya turns custodian of a rare living collection

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Siyambalapitiya’s ancsetral house built on 1923 at Vendala

From Parliament to Fruit Grove:

After more than two decades in politics, rising to the positions of Cabinet Minister and Deputy Speaker of Parliament, Ranjith Siyambalapitiya has turned his attention to a markedly different arena — one far removed from parliamentary debate and political intrigue.

Today, Siyambalapitiya spends much of his time tending to a sprawling 15-acre home garden at Vendala in Karawanella, near Ruwanwella, nurturing what has gradually evolved into one of the most remarkable private fruit collections in the country.

Situated in Sri Lanka’s Wet Zone Low Country agro-ecological region (WL2), Ruwanwella lies at an elevation of roughly 100–200 metres above sea level. Deep red-yellow podzolic soils, annual rainfall exceeding 2,500 millimetres, and a warm humid tropical climate combine to create conditions that make the region one of the richest areas in the island for fruit tree diversity.

Within this favourable ecological setting, Siyambalapitiya has become what may best be described as a custodian of a living collection—a fruit grove that now contains around 554 fruit trees and vines, many of them rare or seldom seen in contemporary agriculture.

Of these, 448 varieties have already been properly identified and documented with the assistance of agriculturist Dr. Suba Heenkenda, a retired expert of the Department of Agriculture. Together they have undertaken the painstaking task of cataloguing the plants by their botanical names, common Sinhala names, and the names used in ancient Ayurvedic and indigenous medical texts, assigning each species a unique identification number.

According to Siyambalapitiya, the Vendala estate is possibly the only single location in Sri Lanka where such a large number of fruit varieties—particularly rare and underutilized species—are maintained within one property.

“This garden came down to me through my grandfather, grandmother, mother and father,” he says. “It is a place shaped by three generations.”

The estate, he explains, began as a traditional home garden where crops such as tea, coconut and rubber were cultivated alongside fruit trees planted by family members over decades. Over time, however, it evolved into something much larger: a carefully nurtured grove preserving both common and obscure fruit species.

Siyambalapitiya recalls with affection one of the oldest trees in the garden—a honey-jack tree known locally as “Lokumänike’s Rata Kos Gaha.”

The story behind it has become part of family lore. According to village elders, his grandmother had brought home the sapling after visiting the Colombo Grand Exhibition in 1952 many decades ago and planted it near the house.

The tree soon gained fame in the village. Its tender jackfruit proved ideal for curry and mallum, while the ripe fruit was renowned for its sweetness.

“Ripe jackfruit from this tree tastes like honey itself,” Siyambalapitiya says. “Even the seeds are full of flour and can be eaten throughout the year.”

Yet age has not spared the venerable tree. It now shows signs of disease, and Siyambalapitiya and his staff have had to treat old wounds and monitor unusual bark damage.

“Once lightning struck it,” he recalls. “The largest branch began to die. Saving the tree required what I would call a kind of surgical operation.”

Such care, he says, reflects the deep attachment he feels toward the collection.

His fascination with fruit trees began in childhood. While attending Royal College in Colombo and living in a boarding house he disliked, Siyambalapitiya would insist that the family procure new fruit saplings for him to plant during his weekend visits home.

“That was the only ‘price’ I demanded for going to school,” he laughs.

Over the years the collection expanded steadily as he encountered new plants in forests, nurseries, and rural landscapes across the island.

The result today is a grove that includes traditional Sri Lankan fruit species, underutilized native varieties, forest fruits, and plants introduced from overseas.

Some species originate in Arabian deserts, while others thrive naturally in cooler climates such as Europe. Certain plants require greenhouse-like conditions, while others are hardy forest trees.

Managing such diversity is no easy task.

“One plant asks for rain, another asks for cold, and yet another prefers heat,” Siyambalapitiya explains. “Too much rain makes some sick, too much sun troubles others. The older trees overshadow the younger ones. You cannot feed or medicate them all in the same way.”

He compares the task to caring for a household filled with people from many nations and ages—each with different needs.

Despite the challenges, he believes the effort is worthwhile, particularly because many of the trees are native species that have become increasingly rare.

“If things continue as they are, some of these plants may disappear from our lives,” he warns.

To preserve knowledge about them, Siyambalapitiya is preparing to launch a book titled “Mage Vendala Palathuru Arana” (My Vendala Fruit Grove), which serves as an introductory guide to the collection.

The book, scheduled for release on April 18 at the Vendala estate, will be attended by Ven. Dr. Kirinde Assaji Thera, Chief Incumbent of Gangaramaya Temple,

Uruwarige Wannila Aththo, the leader of the Indigenous Vedda Community,

a long-serving former employee who helped maintain the plantation, and Sunday Dhamma school students from the region, who will participate as guests of honour.

The publication will also mark Siyambalapitiya’s eighth book. Previously he authored seven works and wrote more than 500 weekly newspaper columns offering commentary on politics and current affairs.

While working on the fruit catalogue, he is simultaneously writing another volume reflecting on his 25-year political career, including his tenure as Deputy Finance Minister during Sri Lanka’s most severe economic crisis.

For Siyambalapitiya, however, the fruit grove represents more than a hobby or academic exercise.

“The fruit we enjoy is the result of a tree’s effort to reproduce,” he says. “Nature has given fruits their taste, fragrance and colour to attract us. All the tree asks in return is that its seeds be carried to new places.”

That simple cycle of life, he believes, has continued for tens of thousands of years.

“And those who love trees,” he adds, “are guardians of the world’s survival.”

by Saman Indrajith

Pix by Tharanga Ratnaweera

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Smoke Free Sweden calls out to WHO not to suggest nicotine alternatives

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It has been reported by the international advocacy initiative, ‘Smoke Free Sweden’ (‘SFS’) that many International health experts have begun criticizing the World Health Organization (WHO) for presenting safer nicotine alternatives rather than recognizing its role in accelerating decline in smoking.

As the world’s premier technical health agency, the WHO is empowered to support strategies that reduce morbidity and mortality even if they do not eliminate the underlying behaviour. Furthermore, it should base its guidance on evolving scientific knowledge, which includes comparative-risk assessments. Equating smoke-free nicotine alternatives with combustible cigarettes, is essentially putting lives at risk, according to the health experts contacted by SFS.

The warning follows recent WHO comments suggesting that vaping and other non-combustible nicotine products are driving tobacco use in Europe. This narrative ignores real-world evidence from countries like Sweden where access to safer alternatives has coincided with record low smoking rates.

A “Smoke-Free” status is defined as an adult daily smoking prevalence below 5% and Sweden is on the brink of officially achieving this milestone. This is clear proof that pragmatic harm-reduction policies work. Sweden’s success has been driven by adult smokers switching to lower-risk alternatives such as oral tobacco pouches (Snus), oral nicotine pouches and other non-combustible products.

“Vapes and pouches are helping to reduce risk, and Sweden’s smoke-free transition proves this,” said Dr Delon Human, leader of Smoke Free Sweden. “We should be celebrating policies that help smokers quit combustible tobacco, not spreading fear about the very tools that are accelerating the decline of cigarettes.”

It is further reported by health experts that conflating cigarettes with non-combustible alternatives risks deterring smokers from switching and could slow progress toward reducing tobacco-related disease.

Dr Human emphasized that youth protection and harm reduction are not mutually exclusive.

“It is critically important to safeguard against underage use, but this should be done by targeted, risk-proportionate regulation and proper enforcement, not by sacrificing the right of adults to access products that might save their lives,” he said.

Smoke Free Sweden is calling on global health authorities to adopt evidence-based policies that distinguish clearly between combustible tobacco – the primary cause of tobacco-related death – and lower-risk nicotine alternatives.

“Public health policy must be grounded in science and real-world outcomes,” Dr Human added. “Sweden’s experience shows that when adult smokers are given legal access to safer nicotine alternatives, smoking rates fall faster than almost anywhere else in the world.”

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