Features
Medicinal drugs for Sri Lanka:The science of safety beyond rhetoric
The recent wave of pharmaceutical tragedies in Sri Lanka, as well as some others that have occurred regularly in the past, has exposed a terrifying reality: our medicine cabinets have become a frontline of risk and potential danger. In recent months, the silent sanctuary of Sri Lanka’s healthcare system has been shattered by a series of tragic, preventable deaths. The common denominator in these tragedies has been a failure in the most basic promise of medicine: that it will heal, not harm. This issue is entirely contrary to the immortal writings of the Father of Medicine, Hippocrates of the island of Kos, who wrote, “Primum non nocere,” which translates classically from Latin as “First do no harm.” The question of the safety of medicinal drugs is, at present, a real dilemma for those of us who, by virtue of our vocation, need to use them to help our patients.
For a nation that imports the vast majority of its medicinal drugs, largely from regional hubs like India, Pakistan, and Bangladesh, the promise of healing is only as strong as the laboratory that verifies these very same medicinal drugs. To prevent further problems, and even loss of lives, we must demand a world-class laboratory infrastructure that operates on science, not just sentiment. We desperately need a total overhaul of our pharmaceutical quality assurance architecture.
The detailed anatomy of a national drug testing facility is not merely a government office. It is a high-precision fortress. To meet international standards like ISO/IEC 17025 and World Health Organisation (WHO) Good Practices for Pharmaceutical Quality Control Laboratories, such a high-quality laboratory must be zoned into specialised units, each designed to catch a different type of failure.
* The Physicochemical Unit: This is where the chemical identity of a drug is confirmed. Using High-Performance Liquid Chromatography (HPLC) and Gas Chromatography-Mass Spectrometry (GC-MS), scientists determine if a “500mg” tablet actually contains 500mg of the active ingredient or if it is filled with useless chalk.
* The Microbiology Suite: This is the most critical area for preventing “injection deaths.” It requires an ISO Class 5 Cleanroom: sterile environments where air is filtered to remove every microscopic particle. Here, technicians perform Sterility Testing to ensure no bacteria or fungi are present in medicines that have to be injected.
* The Instrumentation Wing: Modern testing requires Atomic Absorption Spectrometers to detect heavy metal contaminants (like lead or arsenic) and Stability Chambers to see how drugs react to Sri Lanka’s high humidity.
* The injectable drug contamination is a serious challenge. The most recent fatalities in our hospitals were linked to Intravenous (IV) preparations. When a drug is injected directly into the bloodstream, there is no margin for error. A proper national laboratory must conduct two non-negotiable tests:
* Bacterial Endotoxin Testing (BET): Even if a drug is “sterile” (all bacteria are dead), the dead bacteria leave behind toxic cell wall products called endotoxins. If injected, these residual compounds cause “Pyrogenic Reactions” with violent fevers, organ failure, and death. A functional lab must use the Limulus Amoebocyte Lysate (LAL) test to detect these toxins at the parts-per-billion level.
* Particulate Matter Analysis: Using laser obscuration, labs must verify that no microscopic shards of glass or plastic are floating in the vials. These can cause fatal blood clots or embolisms in the lungs.
It is absolutely vital to assess whether the medicine is available in the preparation in the prescribed amounts and whether it is active and is likely to work. This is Bioavailability. Sri Lanka’s heavy reliance on “generic” imports raises a critical question: Is the cheaper version from abroad as effective as the original, more expensive branded formulation? This is determined by Bioavailability (BA) and Bioequivalence (BE) studies.
A drug might have the right chemical formula, but if it does not dissolve properly in the stomach or reach the blood at the right speed, it is therapeutically useless. Bioavailability measures the rate and extent to which the active ingredient is absorbed into the bloodstream. If a cheaper generic drug is not “bioequivalent” to the original brand-named version, the patient is essentially taking a useless placebo. For patients with heart disease or epilepsy, even a 10% difference in bioavailability can lead to treatment failure. A proper national system must include a facility to conduct these studies, ensuring that every generic drug imported is a true “therapeutic equivalent” to the brand-named original.
As far as testing goes, the current testing philosophy is best described as Reactive, rather than Proactive. The current Sri Lankan system is “reactive”: we test a drug only after a patient has already suffered. This is a proven recipe for disaster. To protect the public, we must shift to a Proactive Surveillance Model of testing ALL drugs at many stages of their dispensing.
* Pre-Marketing Approval: No drug should reach a hospital shelf without “Batch Release” testing. Currently, we often accept the manufacturer’s own certificate of analysis, which is essentially like allowing students to grade their own examination answers.
* Random Post-Marketing Surveillance (PMS): Regulatory inspectors must have the power to walk into any rural pharmacy or state hospital, pick a box of medicine at random, and send it to the lab. This could even catch “substandard” drugs that may have degraded during shipping or storage in our tropical heat. PMS is the Final Safety Net. Even the best laboratories cannot catch every defect. Post-Marketing Surveillance is the ongoing monitoring of a drug’s safety after it has been released to the public. It clearly is the Gold Standard.
* Pharmacovigilance: A robust digital system where every “Adverse Drug Reaction” (ADR) is logged in a national database.
* Signal Detection: An example of this is if three hospitals in different provinces report a slight rash from the same batch of an antibiotic, the system should automatically “flag” that batch for immediate recall before a more severe, unfortunate event takes place.
* Testing for Contaminants: Beyond the active ingredients, we must test for excipient purity. In some global cases, cheaper “glycerin” used in syrups was contaminated with diethylene glycol, a deadly poison. A modern lab must have the technology to screen for these hidden killers.
When one considers the Human Element, Competence and Integrity, the very best equipment in the world is useless without the human capital to run it. A national lab would need the following:
* Highly Trained Pharmacologists and Microbiologists and all grades of staff who are compensated well enough to be immune to the “lobbying” of powerful external agencies.
* Digital Transparency: A database accessible to the public, where any citizen can enter a batch number from their medicine box and see the lab results.
Once a proper system is put in place, we need to assess as to how our facilities measure up against the WHO’s “Model Quality Assurance System.” That will ensure maintenance of internationally recognised standards. The confirmed unfavourable results of any testing procedure, if any, should lead to a very prompt “Blacklist” Initiative, which can be used to legally bar failing manufacturers from future tenders. Such an endeavour would help to keep all drug manufacturers and importers on their toes at all times.
This author believes that this article is based on the premise that the cost of silence by the medical profession would be catastrophic. Quality assurance of medicinal compounds is not an “extra” cost. It is a fundamental right of every Sri Lankan citizen, which is not at all subject to any kind of negotiation. Until our testing facilities match the sophistication of the manufacturers we buy from, we are not just importing medicine; we are importing potential risk.
The promises made by the powers-that-be to “update” the testing laboratories will remain as a rather familiar, unreliable, political theatre until we see a committed budget for mass spectrometry, cleanroom certifications, highly trained and committed staff and a fleet of independent inspectors. Quality control of therapeutic medicines is not a luxury; it is the price to be paid for a portal of entry into a civilised and intensively safe healthcare system. Every time we delay the construction of a comprehensive, proactive testing infrastructure, we are playing a game of Russian Roulette with the lives of our people.
The science is available, and the necessary technology exists. What is missing is the political will to put patient safety as the premier deciding criterion. The time for hollow rhetoric has passed, and the time for a scientifically fortified, transparent, and proactive regulatory mechanism is right now. The good health of all Sri Lankans, as well as even their lives, depend on it.
Dr B. J. C. Perera
MBBS(Cey), DCH(Cey), DCH(Eng), MD(Paediatrics), MRCP(UK), FRCP(Edin), FRCP(Lond), FRCPCH(UK), FSLCPaed, FCCP, Hony. FRCPCH(UK), Hony. FCGP(SL)
Specialist Consultant Paediatrician and Honorary Senior Fellow, Postgraduate Institute of Medicine, University of Colombo, Sri Lanka.
Joint Editor, Sri Lanka Journal of Child Health
Section Editor, Ceylon Medical Journal
Features
Buddhist Approach to Human Challenges
Life, by its very nature, invariably presents a myriad of challenges that are fundamental to the human experience. The various social ills that afflict humanity cannot be understood without recognizing the profound human dynamics at play. Navigating these challenges according to Buddhism involves shifting from attempting to control external circumstances to mastering one’s internal responses. Central to these challenges are certain detrimental drives stemming from pernicious distortions in the functioning of the human mind.
According to Buddhism, human suffering—both on a personal and societal level—arises from three unwholesome roots: greed, hatred, and ignorance or delusion. These roots manifest primarily as the unbridled proliferation of these negative states, serving as the foundation for our conduct. The Buddhist perspective offers profound insights for confronting these difficulties by emphasizing the nature of suffering, known as dukkha. Buddhism teaches that suffering (dukkha) is an inevitable part of life and is fueled by greed, hatred, and ignorance or delusion. This approach promotes mental transformation through mindfulness, ethical living, and the cultivation of wisdom, empowering individuals to confront their struggles with clarity and resilience.
Furthermore, accepting that suffering and difficulty are inherent parts of the human experience—while expecting life to be free of challenges—is, in itself, a cause of suffering. It is also important to recognize that all situations, whether good or bad, are temporary. This understanding helps reduce anxiety when facing difficult times, as these will eventually pass, and it prevents possessiveness during happy moments. Cultivating mindfulness (sati) and living in the present moment without dwelling on the past or worrying about the future is essential.
Understanding that all things—emotions, situations, relationships, and physical bodies—are constantly changing and in a state of flux helps reduce the fear of loss and provides comfort during difficult times, ensuring that we know pain will pass. Moreover, recognizing that the self, or ego, is not a fixed entity minimizes selfish grasping, arrogance, and the tendency to perceive challenges as personal attacks.
At the core of many human challenges lie the three unwholesome mental qualities identified by Buddhism: greed (raga), hatred (dovesa), and ignorance or delusion (avijja or moha). These states of mind serve as obstacles to spiritual progress and underlie a spectrum of harmful thoughts and actions. The Buddha employed powerful metaphors to illustrate these forces, referring to them as the three poisons or fires that ignite suffering and trap beings in the cycle of samsara.
Greed leads to insatiable desires that obscure our awareness of others’ needs, creating a cycle of frustration. Greed encompasses all forms of appetite, such as desire, lust, craving, and longing, manifesting in both physical and mental forms. It embodies the concept of grasping, leading to clinging and an inability to let go. As an unwholesome mental state, greed can become insatiable and inexhaustible. People are often drawn to pleasant things, and no amount of forms, sounds, smells, tastes, tangibles, or mental objects can satisfy their desires. In their intense thirst for possession or gratification of desire, individuals may become trapped in the wheel of samsara, overlooking the needs of marginalized groups based on religion and ethnicity (as noted by Piyadassi Thera). Those who overcome greed realize that all mundane pleasures are fleeting and transient. In a society driven by consumerism, people may find themselves endlessly chasing after things of little value, becoming enslaved by them.
Hatred is another unwholesome mental state that fosters division and conflict, distancing us from genuine relationships. It encompasses unwholesome mental states such as ill will, enmity, hostility, and prejudice. Hatred can be subtle, lying dormant in a person’s mind until it finds expression in unexpected moments. This destructive emotion can degenerate into mass-scale violence and bloodshed within society. Today, hatred and hostility against minorities based on religion and ethnicity are prevalent in many countries. People are often targeted by bigotry and hate, leading to a rise in antagonistic and derogatory behavior toward certain religious and ethnic groups. Hatred, enmity, and retaliation do not foster spiritual well-being; rather, they vitiate our own minds. Buddhists are encouraged to cultivate metta (loving-kindness). Greed and hatred, coupled with ignorance, are the chief causes of the evils that pervade this deluded world. As noted by Narada, “The enemy of the whole world is lust (greed), through which all evils come to living beings. This lust, when obstructed by some cause, transforms into wrath.”
The most profound of these afflictions, ignorance (avijja) or delusion (moha), clouds our judgment and obscures our capacity for understanding, causing us to harm ourselves and others through misguided actions. Addressing bhikkhus, the Buddha declared, ” I do not perceive any single hindrance other than the hindrance of ignorance by which mankind is obstructed, and for so long as in samsara, it is indeed through the hindrance of ignorance that humankind is obstructed and for a long time runs on, wanders in samsara. No other single thing exists like the hindrance of ignorance or delusion, which obstructs humankind and make wander forever. This unwholesome mindset generates negative speech, actions, and thoughts, perpetuating our own suffering. As stated in the Dhammapada, “All mental phenomena have mind as their forerunner; if one speaks or acts with an evil mind, suffering follows.”
Buddhism urges us to go beyond merely addressing the symptoms of our problems. Instead, it invites us to explore the roots of our suffering and examine how greed, hatred, and ignorance manifest in our lives. By uncovering these sources of distress, we can cultivate essential qualities such as compassion, loving-kindness (metta), and acceptance. These virtues are crucial for ethical engagement with significant societal issues, including environmental challenges and social inequality.
In a world marked by material prosperity and emotional chaos, many individuals may feel lost or overwhelmed. The teachings of the Buddha remain relevant today, reminding us that the origins of our struggles often reside within our own minds. By practising ethical self-discipline and steering clear of destructive emotions like jealousy, anger, and arrogance, we can transform our experiences and relationships.
Buddhism teaches that cultivating wholesome mental qualities is essential for spiritual advancement. The positive counterparts to the three unwholesome states are non-greed (alobha), non-hatred (adosa), and non-delusion (amoha). These virtues represent not merely the absence of negativity but also the active presence of beneficial qualities such as generosity (dana), loving kindness (metta), and wisdom (panna). Each of these six mental states serves as a foundation for both personal growth and societal harmony.
Human beings are often tempted by moral transgressions rooted in unwholesome qualities. Actions driven by greed, hatred and ignorance require wisdom and mindful awareness to overcome them, allowing us to see the interconnectedness of all beings and act accordingly.
As we strive to abandon these unwholesome states of mind and cultivate awareness, we contribute positively to our lives and the broader world. By embracing Buddhist teachings, we learn that transforming our minds can significantly impact our experiences and the lives of those around us. Through this mindful practice, we can aspire to create a more compassionate, harmonious existence, transcending the limitations of unwholesome mental states and fostering a deeper connection with ourselves and others.
by Dr. Chandradasa Nanayakkara
Features
How does the Buddha differ?
Buddhism, perhaps, is not a religion if the definition of religion is strictly applied. However, by an extension of that definition, as well as by consensus, Buddhism is considered a religion and is the fourth largest religion with about half a billion followers worldwide. Of the four great religions in the world, Christianity is still way ahead with 2.6 billion adherents, followed by Islam with 1.9 billion and Hinduism with 1.2 billion followers. In most Western Christian countries church attendances are on the decline whilst the numbers following Islam are increasing with Islamic youth displaying signs of increasing religious ardour. There are recent reports that Buddhism has also joined the ranks of shrinking religions. Is this cause for concern? Is this happening by the very nature of Buddhism?
Hinduism, the world’s oldest living religion rooted in the Indus Valley Civilization and dating back at least four millennia, is considered to have evolved from ancient cultural and religious practices than being founded by a single individual, unlike the other three religions. The Buddha differs from Jesus Christ and Prophet Mohammed in many ways, the most important being that there is no higher power involved in what the Buddha discovered.
Jesus Christ is considered the ‘Son of God’ and Christianity is built on the life, resurrection and teachings of Christ with emphasis on the belief in one God expressed through the Trinity: God the Father, Jesus the Son and the Holy Spirit. Therefore, there is no room for questioning the words of the Almighty passed through the Son.
Islam, with its Five Pillars of faith, frequent daily prayers, charity, fasting during Ramadan and pilgrimage to Mecca, is founded on revelations made by Almighty God, Allah, to Mohammed, the last of his Prophets, which are recorded in verse in the Holy Book, Quran. Muslims consider the Quran to be verbatim words of God and the unaltered, final revelation. This leaves even less room for questioning.
In contrast, the Buddha achieved everything by himself with no help from any higher source. Rebelling against some of the practices in the religion to which he was born and seeking a solution to the ever-pervading sense of dissatisfaction, Prince Siddhartha embarked on a journey of discovery that culminated in Enlightenment, under the Bodhi tree on the full moon day of the month of Vesak.
Hinduism, or Sanatana Dharma as traditionally referred to by followers, encompasses the concepts of Karma, Samsara, Moksha and Dharma with a creator Brahma, preserver Vishnu and destroyer Shiva. In addition, there are multitudes of gods serving various functions and there are ritual practices of Puja (worship), Bhakti (devotion), Yajna (sacrificial rites) in addition to meditation and Yoga. The one thing that has blighted Hinduism, on top of sacrifices, is the caste system. The uncompromising attitude of Brahmins led to the formation Sikhism as well, long after the establishment of Buddhism.
Prince Siddhartha studied under eminent teachers of the day, of which there were many, but realised the limitations of their knowledge. Having already given up the extreme of luxury, he went to the other extreme of self-deprivation which after a search for six years, he realised also was not the solution to the problem. Exploring through his mind he realised the truth and came up with the Four Noble Truths and the Noble Eightfold Path. He shunned extremes and proposed the Middle Path which seems to hold sway in many spheres of life, even today.
Buddha’s greatest achievement was the analysis of the mind and scientists are only now establishing the accuracy of the concepts the Buddha elucidated, not with the help of supernatural powers or sophisticated machinery at the disposal of modern-day scientists but by the exploration of the mind by turning the searchlight inwards.
Having discovered the cause of universal dissatisfaction and the path to overcome it, the Buddha walked across vast swathes of India, most likely barefoot, preaching to many, in terms they could understand, as evidenced by the different suttas illustrating the same fact in different ways; to the intelligent it was a short explanation but for others it was a more detailed discussion.
In sharp contrast to all other religious leaders, the Buddha encouraged discussion and challenge before acceptance. What the Buddha stated in the Kalama Sutta, acceptance only after conviction, laid the foundation for scientific thinking.
The Buddha, being a human not supernatural, never claimed infallibility as evidenced by his agreement with his father King Suddhodana that ordaining his son Rahula without permission was a mistake and took steps to ensure that this did not happen again. In fact, the entire Vinaya Pitaka is not an arbitrary rule book laid down by the Buddha, but are the rules the Buddha laid down for the Sangha, based on errant actions by Bhikkhus. Long before the legal concept of retroactive justice was established, the Buddha implemented it in the Vinaya Pitaka.
In an interesting video on YouTube titled “Nature of Buddhism”, Bhante Dhammika of Australia (https://www.youtube.com/watch?v=KY8WfGJq2FI) discusses some unique aspects of Buddhism. Some religions are ‘high demand’ religions where the followers are required to strictly adhere to certain rules which is not the case in Buddhism and he opines that this has led to the gentleness of Buddhists, at times leading to even being lackadaisical! Interestingly, as a widely travelled person, he describes his personal experience of the change of people’s attitudes on going from places with Buddhist influence to others. Speaking of Sri Lanka, where he spent many years, he commends the traditional hospitality as well as lack of cruelty to animals. He refers to “Law based religions” where some things are compulsory whereas in Buddhism there is no compulsion. Buddha was not a lawgiver but recommended good behaviour, giving reasons why and encouraged thinking. Some religions are exclusivist, claiming that there is nothing in other religions. Buddhism is not and Bhante Dhammika refers to an incident where the Buddha encouraged a disciple who converted from Jainism to continue to give alms to his former Jain colleagues.
Have all these strengths of Buddhism become its weakness and the reason for the shrinking number of followers? Had Buddhism demanded more from followers would it have flourished better? Is the numbers game that important? These are interesting questions to ponder over and I am sure, in time, researchers would write theses on these.
Whilst total numbers may diminish in traditional Buddhist areas, more people in the West are recognising the value of the philosophy of Buddhism. Mindfulness, a concept the Buddha introduced is gaining wide acceptance and is increasingly applied in many spheres of modern life. Perhaps, what is important is not the numbers that practise Buddhism as a religion but the lasting influence of the Buddha’s concepts and foundations he laid for modern scientific thinking and analysis of the mind!
By Dr Upul Wijayawardhana
Features
Political violence stalking Trump administration
It would not be particularly revelatory to say that the US is plagued by ‘gun violence’. It is a deeply entrenched and widespread malaise that has come in tandem with the relative ease with which firearms could be acquired and owned by sections of the US public, besides other causes.
However, a third apparent attempt on the life of US President Donald Trump in around two and a half years is both thought-provoking and unsettling for the defenders of democracy. After all, whatever its short comings the US remains the world’s most vibrant democracy and in fact the ‘mightiest’ one. And the US must remain a foremost democracy for the purpose of balancing and offsetting the growing power of authoritarian states in the global power system, who are no friends of genuine representational governance.
Therefore, the recent breaching of the security cordon surrounding the White House Correspondents’ Dinner in Washington at which President Trump and his inner Cabinet were present, by an apparently ‘Lone Wolf’ gunman, besides raising issues relating to the reliability of the security measures deployed for the President, indicates a notable spike in anti-VVIP political violence in particular in the US. It is a pointer to a strong and widespread emergence of anti-democratic forces which seem to be gaining in virulence and destructiveness.
The issues raised by the attack are in the main for the US’ political Right and its supporters. They have smugly and complacently stood by while the extremists in their midst have taken centre stage and begun to dictate the course of Right wing politics. It is the political culture bred by them that leads to ‘Lone Wolf’ gunmen, for instance, who see themselves as being repressed or victimized, taking the law into their own hands, so to speak, and perpetrating ‘revenge attacks’ on the state and society.
A disproportionate degree of attention has been paid particularly internationally to Donald Trump’s personality and his eccentricities but such political persons cannot be divorced from the political culture in which they originate and have their being. That is, “structural” questions matter. Put simply, Donald Trump is a ‘true son’ of the Far Right, his principal support base. The issues raised are therefore for the President as well as his supporters of the Right.
We are obliged to respect the choices of the voting public but in the case of Trump’s election to the highest public position in the US, this columnist is inclined to see in those sections that voted for Trump blind followers of the latter who cared not for their candidate’s suitability, in every relevant respect, and therefore acted irrationally. It would seem that the Right in the US wanted their candidate to win by ‘hook or by crook’ and exercise power on their behalf.
By making the above observations this columnist does not intend to imply that voting publics everywhere in the world of democracy cast their vote sensibly. In the case of Sri Lanka, for example, the question could be raised whether the voters of the country used their vote sensibly when voting into office the majority of Executive Presidents and other persons holding high public office. The obvious answer is ‘no’ and this should lead to a wider public discussion on the dire need for thoroughgoing voter education. The issue is a ‘huge’ one that needs to be addressed in the appropriate forums and is beyond the scope of this column.
Looking back it could be said that the actions of Trump and his die-hard support base led to the Rule of Law in the US being undermined as perhaps never before in modern times. A shaming moment in this connection was the protest march, virtually motivated by Trump, of his supporters to the US Capitol on January 6th, 2021, with the aim of scuttling the presidential poll result of that year. Much violence and unruly behaviour, as known, was let loose. This amounted to denigrating the democratic process and encouraging the violent take over of the state.
In a public address, prior to the unruly conduct of his supporters, Trump is on record as blaring forth the following: ‘We won this election and we won by a landslide’, ‘We will stop the steal’, ‘We will never give up. We will never concede. It doesn’t happen’, ‘If you don’t fight like hell, you’re not going to have a country anymore.’
It is plain to see that such inflammatory utterances could lead impressionable minds in particular to revolt violently. Besides, they should have led the more rationally inclined to wonder whether their candidate was the most suitable person to hold the office of President.
Unfortunately, the latter process was not to be and the question could be raised whether the US is in the ‘safest pair of hands’. Needless to say, as events have revealed, Donald Trump is proving to be one of the most erratic heads of state the US has ever had.
However, the latest attempt on the life of President Trump suggests that considerable damage has been done to the democratic integrity of the US and none other than the President himself has to take on himself a considerable proportion of the blame for such degeneration, besides the US’ Far Right. They could be said to be ‘reaping the whirlwind.’
It is a time for soul-searching by the US Right. The political Right has the right to exist, so the speak, in a functional democracy but it needs to take cognizance of how its political culture is affecting the democratic integrity or health of the US. Ironically, the repressive and chauvinistic politics advocated by it is having the effect of activating counter-violence of the most murderous kind, as was witnessed at the White House Correspondents’ Dinner. Continued repressive politics could only produce more such incidents that could be self-defeating for the US.
Some past US Presidents were assassinated but the present political violence in the country brings into focus as perhaps never before the role that an anti-democratic political culture could play in unraveling the gains that the US has made over the decades. A duty is cast on pro-democracy forces to work collectively towards protecting the democratic integrity and strength of the US.
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