Precision medicine, or personalized medicine, is defined by the National Institutes of Health (NIH), as an approach that customizes prevention, diagnosis, and treatment to each individual by taking into account factors such as genetics, environment, lifestyle, and socioeconomic conditions. Unlike a one-size-fits-all approach, which relies on generalized treatment plans based on broad population averages, precision medicine seeks to optimize care by considering the unique biological and social determinants of health for each patient.

The U.S. government formally launched the Precision Medicine Initiative (PMI) in 2015 to accelerate research and implementation of personalized healthcare solutions. One of the flagship programs under this initiative is the All of Us Research Program, which aims to collect genomic, clinical, and lifestyle data from over one million individuals from diverse backgrounds in the U.S. to build a comprehensive resource for medical research [1]. Further support for precision medicine came in 2016 with the passage of the 21st Century Cures Act, which allocated significant funding to biomedical research, including precision medicine, regenerative medicine, and drug development.

Similarly, Europe has also embraced precision medicine through organizations like the European Partnership for Personalized Medicine (EP PerMed) and the International Consortium for Personalized Medicine (ICPerMed). These initiatives facilitate international collaboration, regulatory frameworks, and research funding to advance the development and implementation of precision medicine across European healthcare systems.

A brief history of Precision Medicine

The idea of precision medicine dates to the time of Hippocrates, who is often regarded as the “father of medicine.” He famously stated that “there is no disease, but the patient,” emphasizing that medical treatment should focus on the whole patient rather than just the disease. As medical science advanced, more concrete evidence supporting precision medicine emerged [2]. For instance, in the 19th century, Louis Pasteur and Robert Koch demonstrated that individuals respond differently to infections, showing the diversity in disease susceptibility. Gregor Mendel’s experiments with pea plants in 1860s laid the foundation for genetics, revealing patterns of inherited traits from parents and their impact on getting certain diseases. In the 1950s, the field of pharmacogenetics emerged after discovering that drug response is linked to an individual’s genetic makeup, meaning that a medication’s effectiveness—or lack thereof—can depend on the genes inherited from one’s parents. In 1990, the Human Genome Project (HGP) started [3], [4] whose goal was to sequence the entire human genome, revolutionizing biomedical research and opening the door to genetically informed disease risk assessment and treatment strategies. After the completion of the HGP in 2003, the rise of Genome-Wide Association Studies (GWAS) has enabled researchers to identify genetic variations associated with various diseases [5]. With the help of GWAS, many genes associated with diseases have been discovered and published in the GWAS catalog.

Examples of Precision Medicine

Several clinical examples of precision medicine already exist. One well-known case involves the CYP2D6 gene, which has multiple variants that affect how individuals metabolize medications. Depending on their CYP2D6 genotype, patients may process drugs quickly or slowly, influencing both effectiveness and side effects. Genotyping allows physicians to choose the right drug and dosage, improving outcomes and minimizing adverse reactions [6].

Another example is HER2-positive breast cancer, a subtype in which cancer cells overexpress the HER2 protein, leading to more aggressive tumors. Targeted drugs such as trastuzumab and pertuzumab block HER2 activity, slowing tumor growth and improving survival [7].

Similarly, in colorectal cancer, mutations in the KRAS gene determine whether patients respond to monoclonal antibody therapies like cetuximab or panitumumab. Only those with wild-type KRAS benefit from these treatments; patients with KRAS mutations require alternatives [8], [9]. Molecular profiling helps ensure that only patients likely to benefit receive these therapies, avoiding unnecessary treatments, reducing costs, and lowering the risk of side effects. This approach has inspired the development of molecular subtyping across many cancer types [10–13].

An emerging area, precision radiomics, uses artificial intelligence and advanced imaging to extract detailed tumor characteristics from medical scans. When integrated with genomic and clinical data, radiomics enables highly tailored radiotherapy plans that deliver optimal radiation doses while protecting healthy tissue, ultimately improving patient outcomes [14].

Computational methods and AI

Despite the promise of precision medicine, making personalized treatments widely accessible remains challenging. Although the goal is to tailor care using genetic, clinical, and lifestyle data, scaling such solutions has proven complex. Several companies have attempted it, but some high-profile efforts have struggled. One well-known example is IBM’s Watson for Oncology, which aimed to use AI for cancer diagnosis and treatment recommendations but ultimately fell short due to biased training data, limited clinical context, and difficulty incorporating real-world expertise.

Recent advances in generative AI and large language models, however, have renewed optimism. Unlike earlier rule-based systems, modern AI can analyze vast patient datasets, detect subtle patterns, and generate insights that may not be immediately apparent to clinicians. This opens new possibilities for improving diagnosis, treatment selection, and patient outcomes.

AI contributes to precision medicine in several ways. It can identify meaningful patterns in clinical records, lifestyle factors, and environmental exposures that correlate with treatment response. By analyzing multimodal data—including genomics, electronic health records, imaging, and wearable devices—AI can determine which patient features matter most and how they interact, guiding more individualized care.

Another key contribution is predicting how a specific patient will respond to a drug or therapy. Deep learning models trained on large datasets can estimate treatment effectiveness, helping clinicians select the most beneficial option. This is essential: missing a life-saving therapy can be fatal, while receiving an ineffective treatment imposes financial, emotional, and physical burdens. AI-driven prediction models help maximize therapeutic benefit while minimizing risk and side effects.

Ethical aspects

While precision medicine offers great potential, it also raises important ethical concerns. A major issue is ensuring that AI models used in healthcare are fair and unbiased. Many systems are trained on datasets that fail to represent diverse populations, leading to unequal or misleading outcomes. Addressing this requires more inclusive data collection and representative training sets. Initiatives like the All of Us Research Program are crucial for reducing bias and ensuring that precision medicine benefits all patients rather than reinforcing existing disparities.

Genetic data privacy is another central concern. Strict safeguards are needed to control who can access such sensitive information and for what purposes. If genetic data were exposed, individuals and their families could face discrimination, stigma, or privacy violations—for example, employers or insurers misusing information about disease risk. Because genetic data is hereditary, breaches affect not only one person but also their relatives and future generations. In the U.S., the Genetic Information Nondiscrimination Act (GINA) of 2008 prohibits discrimination based on genetic information in employment and health insurance, but ongoing policy updates will be essential as technology evolves.

Gene editing, especially germline modification, remains one of the most controversial ethical issues in precision medicine. Somatic editing affects only the treated individual, but germline editing alters DNA in eggs, sperm, or embryos in ways that can be inherited. Although this could prevent certain hereditary diseases, it raises profound moral and societal questions. Misuse could permanently alter the human gene pool or worsen inequalities, and future generations—who cannot consent—would be directly affected. For these reasons, germline editing continues to be one of the most debated topics in bioethics and precision medicine [16].

Future challenges

There are several major challenges to making precision medicine widely accessible.

1. Democratization

Precision medicine must work for people across different demographic and socioeconomic groups. This requires both inclusive datasets and access to the necessary tools worldwide. Mobile health apps that measure basic biological variables could support early diagnosis and preventive care, but scaling treatments globally—and generating high-quality data such as whole-genome sequences—still faces financial and regulatory barriers.

1. Scalability

Precision medicine depends on analyzing massive datasets to discover biomarkers and guide treatment decisions. This requires substantial computational resources and continuous model updates as new data appears. Secure data-sharing across hospitals and countries is essential. Federated learning offers a possible solution by allowing collaborative model development without moving raw patient data [17]. Global coordination—potentially led by organizations like the WHO—is needed to build models that reflect ethnic, racial, and geographic diversity.

1. Handling missing and noisy data

Large biomedical datasets often contain confounding, incomplete, or context-dependent information. Without proper interpretation, this can produce misleading insights. For example, someone visiting the emergency room after an acute trauma may have elevated vitals that do not represent their usual health, which could distort predictive models. External events—such as wildfires triggering asthma spikes—can also skew data if not contextualized. Precision medicine must distinguish meaningful patterns from noise while preserving relevant context.

1. Small sample sizes

Rare diseases often have very few patients, making traditional clinical trials impractical. Transfer learning offers one solution: models trained on large populations can be fine-tuned for small, specific cases. Digital twins—virtual replicas built from a person’s genetic, physiological, and clinical data—can simulate treatment responses and are already being explored in cardiology [18]. Adaptive trial designs, such as N-of-1 studies, also help evaluate treatments for individual patients, while international data-sharing efforts can expand sample sizes for rare disease research [19].

1. Broadening precision medicine across diseases

Although much progress has been made in oncology, precision medicine must be expanded to cardiovascular, neurodegenerative, metabolic, and infectious diseases. Advances in genomics and multi-omics have revealed biologically distinct subtypes within many conditions. For instance, type 2 diabetes, once treated as a uniform disorder, now includes at least five genetically and metabolically distinct subgroups [20], allowing for more targeted therapies based on insulin sensitivity, beta-cell function, and other individual factors.

Conclusion

In the era of big data and AI, the field of precision medicine has great potential to improve across a wide range of diseases. In the future, precision medicine would help preventive medicine efforts for early diagnosis and intervention of diseases by providing tailored treatment and intervention plans. There are several challenges, both technological, social, and ethical, that need to be overcome. Ethicists, policy makers, scientists and medical professionals need to work collaboratively to provide solutions to these challenges to make precision medicine a routine component of healthcare.

References

• All of Us Research Program Investigators et al., “The ‘All of Us’ Research Program,” N Engl J Med, vol. 381, no. 7, pp. 668–676, Aug. 2019, doi: 10.1056/NEJMsr1809937. Also see Yalcin, “Precision Medicine for Everyone: All of Us Research Program Initiative,” The Fountain 166, July 1, 2025.
• S. Visvikis-Siest, D. Theodoridou, M.-S. Kontoe, S. Kumar, and M. Marschler, “Milestones in Personalized Medicine: From the Ancient Time to Nowadays—the Provocation of COVID-19,” Front. Genet., vol. 11, Nov. 2020, doi: 10.3389/ fgene.2020.569175.
• E. S. Lander et al., “Initial sequencing and analysis of the human genome,” Nature, vol. 409, no. 6822, pp. 860–921, 2001.
• J. C. Venter et al., “The sequence of the human genome,” science, vol. 291, no. 5507, pp. 1304–1351, 2001.
• W. S. Bush and J. H. Moore, “Chapter 11: Genome-Wide Association Studies,” PLOS Computational Biology, vol. 8, no. 12, p. e1002822, Dec. 2012, doi: 10.1371/ journal.pcbi.1002822.
• N. A. Nahid and J. A. and Johnson, “CYP2D6 pharmacogenetics and phenoconversion in personalized medicine,” Expert Opinion on Drug Metabolism & Toxicology, vol. 18, no. 11, pp. 769–785, Nov. 2022, doi: 10.1080/ 17425255.2022.2160317.
• S. M. Swain et al., “Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer,” New England Journal of Medicine, vol. 372, no. 8, pp. 724–734, Feb. 2015, doi: 10.1056/NEJMoa1413513.
• A. Bardelli and S. Siena, “Molecular Mechanisms of Resistance to Cetuximab and Panitumumab in Colorectal Cancer,” JCO, vol. 28, no. 7, pp. 1254–1261, Mar. 2010, doi: 10.1200/JCO.2009.24.6116.
• C. Tan and X. Du, “KRAS mutation testing in metastatic colorectal cancer,” World J Gastroenterol, vol. 18, no. 37, pp. 5171–5180, Oct. 2012, doi: 10.3748/ wjg.v18.i37.5171.
• R. Mclendon et al., “Comprehensive genomic characterization defines human glioblastoma genes and core pathways,” Nature, vol. 455, no. 7216, pp. 1061–1068, 2008, doi: 10.1038/nature07385.
• D. C. Koboldt et al., “Comprehensive molecular portraits of human breast tumours,” Nature, vol. 490, no. 7418, pp. 61–70, Oct. 2012, doi: 10.1038/ nature11412.
• C. J. Creighton et al., “Comprehensive molecular characterization of clear cell renal cell carcinoma,” Nature, vol. 499, no. 7456, pp. 43–49, Jul. 2013, doi: 10.1038/ nature12222.
• “Comprehensive molecular profiling of lung adenocarcinoma,” Nature, vol. 511, no. 7511, pp. 543–550, Jul. 2014, doi: 10.1038/nature13385.
• H. J. W. L. Aerts, “The Potential of Radiomic-Based Phenotyping in Precision Medicine: A Review,” JAMA Oncology, vol. 2, no. 12, pp. 1636–1642, Dec. 2016, doi: 10.1001/jamaoncol.2016.2631.
• L. Bonomi, Y. Huang, and L. Ohno-Machado, “Privacy challenges and research opportunities for genomic data sharing,” Nat Genet, vol. 52, no. 7, pp. 646–654, Jul. 2020, doi: 10.1038/s41588-020-0651-0.
• G. Rubeis and F. Steger, “Risks and benefits of human germline genome editing: An ethical analysis,” ABR, vol. 10, no. 2, pp. 133–141, Jul. 2018, doi: 10.1007/s41649-018-0056-x.
• M. Aledhari, R. Razzak, R. M. Parizi, and F. Saeed, “Federated Learning: A Survey on Enabling Technologies, Protocols, and Applications,” IEEE Access, vol. 8, pp. 140699–140725, 2020.
• J. Corral-Acero et al., “The ‘Digital Twin’ to enable the vision of precision cardiology,” European Heart Journal, vol. 41, no. 48, pp. 4556–4564, Dec. 2020, doi: 10.1093/eurheartj/ehaa159.
• E. O. Lillie, Patay ,Bradley, Diamant, Joel, Issell ,Brian, Topol ,Eric J, and N. J. and Schork, “The N-Of-1 Clinical Trial: The Ultimate Strategy For Individualizing Medicine?,” Personalized Medicine, vol. 8, no. 2, pp. 161–173, Mar. 2011, doi: 10.2217/pme.11.7.
• M. Pigeyre et al., “Validation of the classification for type 2 diabetes into five subgroups: a report from the ORIGIN trial,” Diabetologia, vol. 65, no. 1, pp. 206–215, Jan. 2022, doi: 10.1007/s00125-021-05567-4.

During a serene Californian summer retreat, I overheard a captivating conversation between two physicists. In the calm of the setting, their words, filled with passion, seemed to transcend the usual concerns of the world. Unable to resist, I found myself making a “quantum” leap, much like an electron excited to a higher state. Dr. Serdar was enthusiastically discussing proton therapy in cancer treatment, explaining how the proton beam’s properties are carefully coordinated between physicians and physicists during treatment. His words resonated deeply as he reflected on the progress humanity has made in science and the importance of their work. He even joked that if cancer were cured, he would happily switch careers and become a chef.

I enjoyed the conversation and later reflected on how important protons are, despite their small size, and the significant roles they play in serving humanity. In our daily lives, we seldom think of them and “confine” them to the “borders” of a nucleus. Yet, they offer so much more. The more we understand their nature and get to know them, the more they reveal their secrets. Interestingly, to coax them into whispering the codes of their mysterious world, they must be smashed, banged, and subjected to high and low potentials. Harsh as it may sound, aren’t we humans a lot like them? What we do to them, we also face in life. We carry innate positivity within us, yet it often lies dormant, like a seed. Life challenges us with its ups and downs, leading to plenty of “oops” moments. Through these experiences, we uncover new depths, subtle details, and greater discoveries, exploring more of ourselves and the world around us.

Inspired by the discussion, I wanted to dedicate this essay to protons as a tribute to their service, obedience to the laws of their Creator, and the rigor they demonstrate before our eyes. While our tiny titans, protons, constantly make history, let’s take a brief look at their discovery. How they are continually created is, of course, a much larger question – one that goes beyond the scope of this article. The discovery of protons itself spanned over a century. In 1917, Ernest Rutherford discovered the proton by bombarding nitrogen gas with alpha particles. The ejected hydrogen nuclei confirmed the presence of the proton, a fundamental particle in all atomic nuclei. In 1920, he officially named it the “proton,” solidifying its place in atomic theory.

While protons continue to guard their secrets and draw countless researchers with their allure, I was reminded of Said Nursi’s words about creation. In his book The Words, he says, “For sure, ‘to make one thing everything, and everything one thing’ is a sign, a mark, peculiar to the Creator of all things, the One Powerful over all things” (Eighth Word). This “one thing” could refer to anything—an entity or even a particle. Yet, the fact that hydrogen is the most abundant element in the universe, with its nucleus consisting of a single proton, sparked my thoughts once again. It is awe-inspiring to reflect on how the All-Mighty Creator uses the smallest things to bring about indescribable and incomprehensible complexity—complexity that allows us to perceive order amidst the layers of chaos that weave through creation.

Yes, it is small—tiny, even—yet we still have much to learn about protons, as they carry information about the entire creation. I recently watched a fascinating documentary about an artist collaborating with physicists to produce a visual rendering of a proton. The challenges they faced were narrated with remarkable precision and astonishment, highlighting how delicate and complex the structure of a proton is. The work of visualizing such a fundamental particle speaks to the depth of its mystery, and how much more there is to discover. It underscores the power of collaboration between art and

science in shedding light on the unseen world of subatomic particles, revealing the intricate connections that hold protons together in a stable structure.

The proton: Unveiling the mystery of matter

The proton, an electrically positively charged particle at the heart of the atom, is far more complex than it first appears, resisting simple characterization. Its behavior and structure change depending on how it is probed, revealing a layer of complexity that challenges our understanding at every turn.

In 1967, experiments at SLAC (the Stanford Linear Accelerator Center) revealed that protons are composed of point-like particles known as quarks—two “up” quarks and one “down” quark—each with distinct electrical charges. Quantum Chromodynamics (QCD) advanced our understanding further, revealing that the proton is not just made of quarks but also hosts a “sea” of transient quarks, antiquarks, and gluons. These fleeting particles interact continuously, contributing to the proton’s mass, spin, and stability. This makes the proton’s internal structure one of the most enigmatic puzzles in modern physics. While it would be fascinating to elaborate more on these features, let’s keep our focus and continue exploring their significance. Despite decades of study, the proton continues to surprise us. It’s not just a fundamental building block of matter, but a window into deeper truths about the universe.

The many roles of protons: From medicine to technology

Protons are not just essential in medicine; they are the essence of an element’s identity. Think of them as an ID, SSN, or passport number—defining the diversity of materials and elements in the universe. The number of protons in an atom’s nucleus, or atomic number, uniquely identifies an element on the periodic table. This fundamental role underscores their significance, extending beyond applications like proton therapy, where their unique properties are utilized for precise cancer treatments.

First of all, protons are positively charged particles with significant mass compared to electrons. This allows precise control over their path in a magnetic or electric field. Medical physicists can more easily control their path, direct them to the targeted tissues, and obtain more effective results in their use. Protons deliver the majority of their energy at a specific depth in tissue, known as the “Bragg peak.” This characteristic allows protons to release their maximum energy at the tumor site while minimizing damage to surrounding healthy tissue. This property makes them safer to use compared to gamma or X-rays. Protons scatter less as they travel through tissues, which enhances their precision and reduces the dose to non-targeted areas. Protons ionize atoms in their path, effectively damaging cancer cell DNA and inhibiting replication, which is crucial for stopping tumor growth.

Protons were first employed in medical treatment in 1946 (Wilson, 1946), and today, proton therapy is a widely recognized method for cancer treatment. Compared to traditional x-ray radiotherapy, proton therapy offers a significant advantage by reducing the risk of secondary cancers. This is due to its ability to precisely deliver radiation to the tumor site while minimizing damage to surrounding healthy tissue. The proton beam’s interactions with matter allow for a concentration of radiation in areas where it is most needed, either in the tumor or healthy tissues, depending on the depth of the proton path (Newhauser and Zhang, 2015). Protons, though small in scale, are powerful tools in treating humans, demonstrating how even the tiniest elements can have a profound impact on healing. Indeed, the Creator, The Healer, has made the universe akin to a vast pharmacy, full of treatments, medicines, and chemicals—inviting us to explore, fueled by curiosity, and to deepen our understanding of His creation.

Expanding frontiers: Protons in everyday life

Protons have a wide range of important uses beyond their role in medicine. In electronics, proton implantation in silicon carbide semiconductors enhances the reliability and efficiency of devices, benefiting sectors like transportation and renewable energy. They are also crucial in space missions, testing electronics for reliability in harsh radiation environments, and in self-driving cars and medical devices. Protons are key in energy production through proton exchange membrane fuel cells, scientific research in particle accelerators, and even in food preservation by sterilization. Their versatile applications continue to advance both cutting-edge technologies and everyday innovations.

Despite their smallness, protons shoulder immense responsibilities, obeying the laws set by their Creator. They pave the way for new discoveries, sparking human curiosity and unlocking pathways to a deeper understanding of ever-smaller particles and their interactions with the universe. From the tiniest particles to the vastest structures, everything in creation is crafted with meticulous planning, calculation, and preordained precision. Though we cannot perceive it all with our naked eye, the Creator has bestowed upon us the mind, eyes, and tools to glimpse His infinite power—shaping boundless complexity from the smallest things. As stated in the Quran, “Not ‘even’ an atom’s weight is hidden from Him in the heavens or the earth; nor anything smaller or larger than that, but is ‘written’ in a perfect record.” (Al-Saba 34:3) Indeed, “We have created everything, perfectly preordained.” (Al-Qamar 54:49).

References and Resources Used

National Institutes of Health. Proton Therapy: A Summary of Current Research and Clinical Applications. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4407514/

EurekaAlert. Proton Implantation and Its Role in Enhancing Semiconductor Reliability. Retrieved from https://www.eurekalert.org/news-releases/972656#

NASA Technical Report on Proton Uses in Instrument Calibration:

NASA. Proton Uses in Instrument Calibration for Space Exploration. Retrieved from https://ntrs.nasa.gov/api/citations/20170011270/downloads/20170011270.pdf

GeeksforGeeks Article on Everyday Uses of Protons: https://www.geeksforgeeks.org/uses-of-protons-in-everyday-life/

Documentary on the Visualization of Protons. https://www.youtube.com/watch?v=e2FrALuacZ4

Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and/or unexpected.

For example, thalidomide was introduced in the late 1950s as a sedative and a treatment for morning sickness in pregnant women. By the early 1960s, reports began to emerge of severe birth defects associated with its use, including phocomelia, a condition characterized by the malformation of limbs. The thalidomide crisis resulted in significant human suffering and marked a turning point in drug regulation. Thalidomide was sold in over 46 countries, with the highest number of cases reported in Germany, the UK, Canada, and Australia. It’s estimated that around 10,000 babies were born with thalidomide-related birth defects worldwide. These numbers underscore the profound impact of the thalidomide crisis on public health and drug regulation. The crisis prompted significant changes in drug regulation, leading to the enactment of stricter testing and approval processes, such as the 1962 Kefauver-Harris Amendment in the U.S.

All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period of time (Figure).

Figure. Overview of investigation into drug safety in the United States.

· Medicines may affect the body in unintended, harmful ways. These effects, called side effects, adverse events or adverse reactions, represent the risks of taking medication. An adverse drug reaction (ADR) can be defined as ‘an appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product; adverse effects usually predict hazard from future administration and warrant prevention, or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.’ Since 2012, the definition has expanded to include reactions resulting from errors, misuse, or abuse, as well as suspected reactions to unlicensed or off-label uses of medicines, in addition to those occurring with authorized use at normal doses. Adverse drug reactions have been observed and monitored for many years: In 1937, 107 deaths, many in children, occurred in the United States from the use of a cough syrup that used diethylene glycol as a solvent. This event led to the 1938 Food, Drug, and Cosmetic Act, which for the first time required proof of safety prior to marketing.

· In 1955, over 40,000 children developed abortive polio (51 of whom were permanently paralyzed) and five died from a polio vaccine made by Cutter Laboratories that was not effectively inactivated during manufacturing. The incident also sparked a polio epidemic in the families and communities of those immunized with the defective vaccine, leading to an additional 113 people who were paralyzed and five more deaths. In ensuing law suits, it was determined that pharmaceutical companies could be held liable for harm from their products even if there was no negligence.

· In 1961, more than 10,000 children worldwide were born with severe birth defects (phocomelia) due to in utero exposure to thalidomide, a drug that had been used to treat pregnancy-related nausea. Even though thalidomide had not been released in the United States, this event led to the Kefauver–Harris Amendment, which strengthened the requirements for safety testing and for the first-time required proof of efficacy prior to a drug being marketed. This public health disaster also spurred the development of formal spontaneous reporting systems for pharmacovigilance, which are still the primary method of identifying safety issues in approved medications.

· In the 1970s, it was discovered that diethylstilbestrol caused clear cell adenocarcinoma of the cervix and vagina in women exposed in utero decades earlier.

· In 1984, psoralen and ultraviolet A (PUVA) was definitively linked to an increased risk of squamous cell carcinoma, approximately 10 years after the first description of PUVA therapy for psoriasis. It took over 20 years to establish a link between PUVA and melanoma, which remains controversial.

· Of drugs approved by the US Food and Drug Administration (FDA) between 1996 and 2012, one-third received boxed warnings and more than 40% of these drugs acquired the warning a median time of 4 years after approval.

· Since 2000, many of the prescription drugs removed from the market include classes of medications that are commonly prescribed, such as antihistamines (e.g., terfenadine), nonsteroidal anti-inflammatory agents (rofecoxib, valdecoxib), antibiotics (trovafloxacin), lipid-lowering medications (cerivastatin), and an immunosuppressant for the treatment of psoriasis (efalizumab).

· Between 2008 and 2015, 29% of boxed warnings issued to drugs on the US market were new and 32% were major updates to previous warnings.

· The incidence of adverse drug reactions has remained relatively unchanged over time, with research suggesting that between 5% and 10% of patients may suffer from an ADR at admission, during admission or at discharge, despite various preventative efforts.

· In 2012, McKinsey & Company estimated that the cost of 50 to 100 million preventable, error-related adverse drug events ranged from $18 billion to $115 billion.

It is important to quickly identify new risks or changes to known risks associated with the use of medicines. Timely actions must be taken to minimize these risks, maximize the benefits, and promote the safe and effective use of medicines by patients. These activities are collectively known as pharmacovigilance.

Pharmacovigilance, also known as drug safety, is the pharmaceutical science concerned with the “collection, detection, assessment, monitoring, and prevention” of adverse effects associated with pharmaceutical products. The term “pharmacovigilance” is derived from the Greek wordpharmakon(meaning drug) and the Latin wordvigilare(to keep watch). As such, pharmacovigilance focuses primarily on adverse drug reactions, defined as any noxious and unintended response to a drug, including lack of efficacy. Medication errors—such as overdose, misuse, abuse, and drug exposure during pregnancy or breastfeeding—are also of interest, even when no adverse event has occurred, due to their potential to result in harm.

In recent years, the scope of pharmacovigilance has expanded to include:

· Herbals

· Traditional and complementary medicines

· Blood products

· Biologicals

· Medical devices

· Vaccines

Many other issues are also relevant to the science of pharmacovigilance, including:

· Substandard medicines

· Medication errors

· Reports of lack of efficacy

· Use of medicines for unapproved indications with insufficient scientific support

· Case reports of acute and chronic poisoning

· Assessment of drug-related mortality

· Abuse and misuse of medicines

· Adverse interactions between medicines and chemicals, other drugs, or food

Pharmacovigilance activities include:

• Collecting and managing data on the safety of medicines
• Looking at the data to detect “signals” (any new or changing safety issue)
• Evaluating the data and making decisions with regard to safety issues
• Pro-active risk management to minimize any potential associated risks
• Acting to protect public health (including regulatory action)
• Communicating with and informing stakeholders and the public
• Audit of the outcomes and key processes involved.

The specific aims of pharmacovigilance are to:

· Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions

· Enhance public health and safety concerning the use of medicines

· Contribute to the assessment of the benefits, harms, effectiveness, and risks of medicines, thereby encouraging their safe, rational, and more effective—including cost-effective—use

· Promote understanding, education, and clinical training in pharmacovigilance, along with effective communication to the public

Information received from patients and healthcare providers via pharmacovigilance agreements, as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority.

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.

The activity that is most commonly associated with pharmacovigilance and which consumes a significant number of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting. Adverse event reporting involves the receipt, triage, data entry, assessment, distribution, reporting (if appropriate), and archiving of adverse event data and documentation. The source of adverse event reports may include spontaneous reports from healthcare professionals or patients, solicited reports from patient support programs, reports from clinical or post-marketing studies, reports from literature sources, reports from the media (including social media and websites), and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, adverse event reporting is a regulatory requirement in most countries. This reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug.

Organizations such as World Health Organization (WHO), International Council for Harmonization (ICH), The Council for International Organizations of Medical Science (CIOMS), and International Society of Pharmacovigilance play a key collaborative role in the global oversight of pharmacovigilance.

The number of National Centers participating in the WHO International Drug Monitoring Program has grown from 10 in 1968, when the program began, to 67 in 2002, and continues to increase. The centers vary considerably in size, resources, support structure, and scope of activities. Collecting spontaneous reports of suspected adverse drug reactions remains their core activity.

In conclusion, maintaining balance in life is essential in all aspects. The usefulness of almost anything can diminish and even become harmful when used excessively. Although medicines play a vital role in healthcare, their effects must be closely monitored to prevent potential adverse events. In addition, with the rapid spread of drug information worldwide—especially highlighted during the COVID-19 pandemic—there is a growing need for routine and timely communication between National Centers and national regulatory authorities. Many regulatory bodies across different regions have established strong collaborations to share safety data, discuss regulatory decisions, and align on policies. Regular dialogue and coordination among National Centers are crucial to ensuring the safe and effective use of medicines.

References

1. https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance

2. Offit P. The Cutter incident, 50 years later. N Engl J Med. 2005;352(14):1411–1412.

3. Talbot JC, Nilsson BS. Pharmacovigilance in the pharmaceutical industry. Br J Clin Pharmacol. 1998 May;45(5):427-31. doi: 10.1046/j.1365-2125.1998.00713.x. PMID: 9643613; PMCID: PMC1873545.

4. Solotke MT, Dhruva SS, Downing NS, Shah ND, Ross JS. New and incremental FDA black box warnings from 2008 to 2015. Expert Opin Drug Saf. 2018;17:117–123.

5. Coleman JJ, Pontefract SK. Adverse drug reactions. Clin Med (Lond). 2016 Oct;16(5):481-485. doi: 10.7861/clinmedicine.16-5-481. PMID: 27697815; PMCID: PMC6297296.

6. Ebel T, George K, Larsen E, Neal E, Shah K, Shi D (October 2012). “Strength in unity:The promise of global standards in healthcare” (PDF). gs1.org. McKinsey & Company.

We are bombarded with hundreds, if not thousands, of “signals” in our day-to-day lives, such as phone notifications or TV ads. These signals are designed to draw our attention, but we are so used to them that we usually don’t give them a second thought. Now think of a deafening fire alarm or a foul-smelling gas leak. Hard to ignore, right? That means they have been designed well, since their goal is to warn you of impending danger.

For many people, even reading the word “pain” may elicit unpleasant memories or emotions. Wouldn’t it be great to never feel pain? Why does it even exist? Well, like the examples given above, pain is the body’s alarm system that we cannot ignore and should be thankful for. Our brain is a complicated hub that receives and sends out innumerable signals every second and is in constant communication with every corner of the body. Whenever an organ is in distress, it alerts the brain. In turn, the brain prioritizes that organ by sending back a specialized signal—one that we perceive as pain.

Let’s take a deeper dive into how the pain signal is transmitted and where it goes. Similar to our senses of touch and temperature, pain is transmitted through neurons in the spinal cord that connect to the pain centers in the brain. The two main types of nerve fibers involved in carrying pain signals are called Type A and Type C nerve fibers. Type A nerve fibers are larger and covered in an electrical isolating material called myelin. These characteristics allow for the pain signal to be transmitted very quickly. The pain we feel when these nerves are stimulated is fast and sharp, like from a cut. Type C nerve fibers are thinner and are not electrically isolated, causing the pain signals to travel slower. The pain we feel when these nerves are stimulated is slow and dull, like from a bruise.

Wired for quick action

The varying structures of nerve fibers lead to different types of pain; however, the way they are wired is even more fascinating! Although a portion of these nerve fibers travel up to the brain to produce the sensation of pain, a portion of them also connect directly to another set of nerve fibers in the spinal cord that control our muscles. This basically forms a short circuit that causes us to retract our limb from the source of pain, like when we touch something hot. This decision is not made by the brain and is out of our control. This reflex is therefore called a “spinal cord reflex” and can occur even in patients diagnosed as brain dead! Our body is wired to trigger quick and decisive actions that protect us from harm.

Humankind has yet to invent a better and more precise medical alarm system than pain. Someone experiencing pain cannot work, cannot eat, and cannot sleep. They will go to any lengths to alleviate that pain. Although painkillers may provide temporary relief, pain will not relent until the problem is solved. Therefore, people with pain end up seeing a doctor. Although it may sound cruel, pain is a doctor’s best friend. In most cases, it tells them exactly what is wrong. A fire alarm cannot tell you where the fire is; it only tells you that it exists. Pain does so much more. There are many different types and qualities of pain, some of which are extremely specific for certain conditions. Let’s go over some common causes of pain and see how temporary suffering can prevent permanent lifelong consequences.

Let’s start with the pain we are most familiar with: the headache. In most cases, headaches are mild inconveniences caused by stress. These mild headaches are great at highlighting the things that cause our bodies stress, such as overworking, loud noises, or bright lights. People learn from their headaches and begin avoiding these stressors, preventing longer term damage to their bodies. In more extreme cases, however, headaches can be the first symptom of something more dangerous. Persistent and severe headaches usually warrant further workup and can help doctors catch high blood pressure or brain masses at their early stages.

Another common source of pain is the belly. Abdominal pain comes in all shapes and sizes; it can be sharp, achy, or crampy. It can be in a certain spot or all over. It can even move around! Our bellies are home to most of our organs, each with their own “pain signature.” An appendix that is about to burst starts signaling as a generalized pain across the belly, which later localizes until it becomes a sharp pain in the right lower corner. A gallbladder burdened by stones is more sudden and consistent; it signals the right upper corner and stays put. A distressed stomach signals the upper middle; twisted intestines signal the lower left; and obstructed kidneys signal the sides. To laypeople, all of these are a “bellyache.” But to doctors, these pain signatures serve as a window into your insides and help prevent catastrophe.

The impending doom!

Our last example is probably the most dreaded one, and for good reason: chest pain. Even though the chest doesn’t house as many organs as the belly, the ones that do reside there are the most vital ones – most notably, our heart. The pain radiated by a heart that is thirsty for oxygen is unique. Suddenly, you feel as if an elephant sat on your chest, and this sensation may extend to your arms or neck. This pain is usually accompanied by shortness of breath and a sense of impending doom (yes, this is a real medical term!). The severity of the pain is proportional to the severity of the condition, and anyone who reports this kind of chest pain will be taken seriously in the hospital. Usually, an obstructed blood vessel is found in the heart, which is then opened or bypassed, terminating the pain. If done early enough, this intervention can prevent a fatal heart attack looming around the corner.

If our body is like a priceless spaceship with the utmost sophistication, then it makes sense that it has an advanced and detailed alarm and early detection system constantly monitored by innumerable screens in the spaceship’s command center. If an engine is about to fail, you see a signal on one monitor; if fuel is about to run out, you detect it on another monitor; if the air pressure in the cabin is lower or higher than desired, still another monitor sends you a message; if a gear loses grip, you can tell which one it is exactly among thousands just by checking yet another monitor. Isn’t it obvious that we are blessed with such a painstakingly wondrous body entrusted to us to maintain and use properly?

The emergency room shift that evening was quite calm. We were drinking coffee and chatting in the doctors’ room. Michael, a young doctor who had started in the department only two weeks ago, had already adapted to the new environment. He was asking me questions, as I was his senior shift partner. At that moment, there was a knock on the door and the nurse said we had a patient. Michael and I followed her. The patient was lying on the bed. His face showed clear signs of suffering. I introduced Michael and myself and started talking with the patient. Michael started listening and taking notes.

The 52-year-old male patient had come in with left arm pain that started a few hours ago. According to the patient, he had been chopping wood in the garden that day and had strained his arm significantly. I asked the patient about the nature of his pain, whether he had experienced similar pain before, if he had been diagnosed with any other illnesses, his alcohol and tobacco consumption, and if there were any family members diagnosed with heart disease or who had died at a young age.

It seemed that the pain might have been muscle and joint-related due to straining his arm, but considering the risk factors in his history, the pain could also be heart-related. The next step was to listen to his body and see what it would tell us.

In such situations, I compare myself to a detective searching for evidence. Meanwhile, we began examining the patient. I first examined his arm, listened to his chest and back with a stethoscope, and then checked his legs. After finishing the examination, we decided to perform an ECG (electrocardiography) test on the patient. I quickly filled out the laboratory request form.

Michael brought the ECG machine, placed electrodes on his arms, legs, and chest, and pressed the button. As the machine worked, a long strip of paper began to emerge. As I examined the paper, I said, “Look, there’s an ST elevation in the V4-V6 leads.” This indicated that our patient was having an acute myocardial infarction (heart attack) and the front part of the heart is affected by this condition.

“Let’s inform the angiography unit immediately so they can take over the patient.” Then I had a brief phone conversation with the relevant department. The angiography team arrived within minutes and took the patient away. As we walked back to the doctors’ room, we felt glad about being able to help a critically ill patient in time. Shortly after, we received a call from the laboratory informing them that the patient’s test results were also alarmingly high.

I thought to myself that the patient’s tissues are almost talking to us in their own language; they were affirming the heart attack diagnosis. I see medicine as a way of understanding the messages coming from creation. Each organ has its unique language, and if we know this language, we can understand what it is saying. The human body is such a wonder that years at medical school is not enough to learn all nuances of its peculiar language, so we continue our education to specialize in each organ.

If you place a stethoscope on a patient’s chest as a layperson and listen to the heart, it will give some rhythmical “tick-tock” sounds. To an expert ear, however, it whispers about a stenosis, insufficiency, or a hole between the ventricles or atria. With the ECG, which helps us diagnose, we measure the electrical activity of the heart. This allows us to evaluate not only the rhythm and rate of the heart but also signs of an acute or past heart attack. In recent years, advancements in the electrophysiological studies of the heart have been so significant that this area has become a standalone field to study.

We examined the enzymes and proteins from the heart muscle cells in the patient’s blood, which indicated muscle damage. These biomarkers also brought us news from the cells. Based on their levels, we confirmed that the patient had a heart attack. By analyzing these values, we could even estimate the approximate duration of the condition.

There are other methods used to see the condition of the heart. Echocardiography, which uses ultrasound waves, assesses the anatomical structure of the heart, including the valves, ventricles, and atria, and determines how well the heart performs its pumping function through measurements. In a scintigraphy test, they check for the presence of live tissue in the relevant heart region. Angiography examines the blood vessels supplying the heart to determine where any narrowing occurs and whether to place a stent or use surgical methods such as a bypass.

In every department, there are specialized examination methods, specific tests, and analyses tailored to communicate with relevant organs. For instance, the examination and diagnostic methods used for the neurological system are very different from those used in other departments. There are special devices for evaluating the brain. An EEG (electroencephalography) measures the brain’s electrical waves to diagnose diseases affecting brain functions. While the test results might appear as complex curves to other doctors, to neurologists who understand this language, those waves convey meaningful messages.

The work of forensic medicine doctors is fascinating in a unique way. Their witnesses cannot speak, yet they can determine the cause and even the time of death, through the “testimony” of the organs and tissues examined during an autopsy.

This “testimony” makes me think of how we use our body and organs in this world and how we will be asked about it in the next: “… their ears, and their eyes, and their skins will bear witness against them as to all that they did habitually” (Qur’an 41:20); “That Day, We will set a seal upon their mouths, and their hands will speak to Us, and their feet will bear witness to what they earned (in the world) (Qur’an 36:65).

Deepening our reflections in this respect, I cannot help but think this: Just as we can detect traces of diseases years later through antibodies produced in the blood from infectious diseases, is it possible to talk about the spiritual traces left by sins?”

When two of his companions were backbiting their friend, Prophet Muhammad (peace be upon him) told them that he could see the flesh of their brother between their teeth. This suggests that sins do leave some spiritual marks. The Prophet also said, “A black spot appears on the heart of a person who commits a sin. If he repents, that stain is erased. If he continues to sin without repenting, the stain grows and eventually covers his entire heart, making it completely black.” Sins, much like untreated or repeatedly occurring diseases that become chronic and more resistant to treatment, also cause spiritual damage when they become “repeated/chronic sins.” Just as some diseases can be treated and heal without leaving any marks, sincere repentance can erase the stains on the spiritual heart.

These were my reflections after helping a patient by studying the available signs. Perhaps a doctor’s contemplation should be like this. Just then, there was a knock on the door. A nurse had come to inform me that there was a new patient waiting in the emergency room. I stood up immediately.

Aisha set out on the road with her newly purchased car. After covering some distance, a warning light in the car turned on, which she didn’t recognize. Initially, she didn’t pay much attention to this light and continued on her way. However, after a while she needed to tow the car and the mechanics told her that it was a good thing that she came, as ignoring these lights and continuing on the road could have led to a serious malfunction that might endanger her life.

Jason and his family planned for a trip and were going to hit the road early in the morning. After dinner, Jason felt a pain in his abdomen, but he didn’t tell anyone. However, the pain intensified, and he began to feel nauseous, so he took a painkiller. The pain did not go away, so he decided it was time to go to the hospital. When they arrived at the hospital, the doctor examined Jason and, the first thing Jason wanted was to get rid of the pain as soon as possible. However, the doctor said that using painkillers wouldn’t be right, as it was important to understand the course and type of the pain for diagnosis. When the blood tests and ultrasound results came in, it was revealed that Jason had appendicitis and needed urgent surgery. If they had waited a little longer, there was a possibility of the appendix perforating, which would make the surgery much more complex. Although Jason couldn’t go on the vacation he had been waiting for years, he realized the importance of symptoms like pain, nausea, vomiting, and fever, despite their discomfort. Jason gained a newfound appreciation for the delicate balance between listening to the body and understanding its signals.

Aisha’s car had a way of communicating problems through warning lights. Similarly, our body has its own language, expressing issues not through words but through symptoms, as in Jason’s case. What are the signals our body uses, and how can we understand this language?

People may use the words “sign” and “symptom” interchangeably in medical manners. However, a symptom is something an individual experiences, while a sign is something a doctor, or other person, notices. Symptom is defined as something that a person feels or experiences that may indicate that they have a disease or condition. Symptoms can only be reported by the person experiencing them. They cannot be observed by a health care provider or other person and do not show up on medical tests. Symptoms, often considered as the body’s alarm system, play a crucial role in the realm of diseases. Symptoms serve as valuable indicators that guide healthcare professionals in the diagnostic process and treatment planning. This article explores the essential usefulness of symptoms in understanding diseases and their importance in healthcare strategies. Frequently seen examples of disease symptoms are pain, fever, nausea, vomiting, fatigue, and loss of appetite.

Pain: Pain is described as a localized or generalized unpleasant bodily sensation or complex of sensations that causes mild to severe physical discomfort and emotional distress, typically resulting from a bodily disorder, such as injury or disease, by the International Association for the Study of Pain.

Pain is always subjective. Each individual learns pain through experiences related to injury in early life. It is unquestionably a sensation in a part or parts of the body, but it is also always unpleasant, and therefore, also an emotional experience.

But many people report pain in the absence of tissue damage or any likely pathophysiological cause; this usually happens for psychological reasons. There is no way to distinguish their experience from pain due to tissue damage if we rely solely on the subjective report. If they regard their experience as pain and if they report it in the same way as pain caused by tissue damage, it should be accepted as pain.

Although the characteristics of pain may differ, the role is still the same; pain is the body’s alert system. For example, pain as a symptom of another illness can be a significant factor in early diagnosis and treatment. Pain is one of the top reasons why people seek emergency care. Therefore, from injuries to heart attacks to cancer, functional pain is associated with identification of these conditions and potentially the prevention of more serious outcomes.

Congenital insensitivity to pain, also known as congenital analgesia, is a rare condition in which a person cannot feel (and has never felt) physical pain. It has been estimated to have a worldwide incidence of approximately 1 in every 25,000 live births. Because feeling physical pain is vital for survival, this insensitivity is an extremely dangerous condition.  Since children and adults with this disorder cannot feel pain, they may not respond to problems, thus are at a higher risk of more severe diseases. Children with this condition often sustain damage both in and around the oral cavity, such as biting off the tip of their tongue, or suffer fractures to their bones.

Fever: A fever is an abnormal rise in body temperature. It is most often a sign of infection but can be present whenever there is tissue destruction, such as, for example, from a severe burn or when large amounts of tissue have died due to a lack of blood supply. Body temperature is controlled by the thermostatic center in the hypothalamus. Fever in humans is a body temperature above the normal range due to an increase in the body’s temperature set point in the hypothalamus. Certain protein and polysaccharide substances called pyrogens, released either from bacteria or viruses or from destroyed cells of the body, are capable of raising the thermostat and causing a rise in body temperature. Fever is a highly significant indicator of disease.

Nausea and vomiting: Nausea has been defined as an “unpleasant painless subjective feeling that one will imminently vomit.” While nausea and vomiting are often thought to exist on a temporal continuum, sometimes they may occur in the absence of each other.

In population studies, more than 50% of adults reported at least one episode of nausea, and more than 30% of adults reported one episode of vomiting within the preceding 12 months, with women reporting more episodes of nausea than men. Nausea is considered to function as a protective mechanism, warning the organism to avoid potential toxic ingestion. Nausea and vomiting may also be early warning signs of more serious medical problems, such as appendicitis (like Jason’s case above), a blockage in the intestines, cancer, ingesting a drug or poison, especially by children.

Vomiting is our body’s emergency response to poisoning. It’s kind of a “dump everything!” panic response. When the body detects potentially toxic compounds in the digestive system, it initiates a cascade of physiological responses, including nausea and the urge to vomit. By expelling these substances from the stomach and gastrointestinal tract, the body prevents their absorption into the bloodstream, thereby reducing the risk of poisoning or systemic damage.

Fatigue: Fatigue is a multifaceted and complex phenomenon characterized by a persistent feeling of physical or mental tiredness, weakness, or lack of energy. It transcends mere tiredness, as it often persists even after rest or sleep, significantly impacting an individual’s quality of life and daily functioning. While fatigue is a common experience that everyone encounters at some point in their lives, chronic or persistent fatigue can be indicative of underlying health issues or diseases.

In many cases, fatigue acts as the body’s alarm system, signaling an imbalance or dysfunction within the body. It can be a prominent feature of various acute and chronic illnesses, including autoimmune disorders, infectious diseases, neurological conditions, and mental health disorders.

Appetite loss: This symptom refers to a diminished desire or interest in eating, often resulting in reduced food intake. It can manifest as a complete aversion to food or a decreased enjoyment of eating, leading to unintentional weight loss and nutritional deficiencies. Appetite loss can stem from various factors, including physiological changes, psychological distress, medication side effects, and underlying medical conditions. While occasional fluctuations in appetite are normal and may occur due to temporary factors such as stress or illness, persistent or severe appetite loss can be indicative of more serious health issues and warrants medical attention.

Understanding appetite loss is crucial in disease prognosis and treatment as it serves as a significant clinical indicator and prognostic factor for various medical conditions. In many cases, appetite loss accompanies acute illnesses such as infections or gastrointestinal disturbances, serving as a protective mechanism that redirects energy towards the body’s immune response. However, chronic appetite loss, particularly when associated with unintentional weight loss, can signify underlying chronic diseases such as cancer, chronic infections, autoimmune disorders, or gastrointestinal disorders. Monitoring changes in appetite and nutritional status is essential for disease management, as malnutrition and weight loss can exacerbate disease progression, impair treatment response, and negatively impact overall prognosis

Cough: Coughing is a reflex action that serves as the body’s natural defense mechanism to clear the airways of irritants, mucus, or foreign particles. It involves a sudden expulsion of air from the lungs, typically accompanied by a distinctive sound. While coughing is a normal and essential bodily function, persistent or severe coughing can indicate underlying health issues or diseases. Monitoring the onset, duration, severity, and accompanying symptoms of a cough is essential for healthcare providers to determine the underlying cause and appropriate treatment plan, highlighting the importance of cough as a diagnostic tool in the assessment of respiratory health.

Headache, shortness of breath, palpitation, weight loss, rash and swelling are the other most frequent disease symptoms, alongside many others. Although we don’t like experiencing these symptoms, they actually help us in many ways, such as:

1. Early detection and diagnosis: Symptoms function as initial indicators, signaling potential health concerns to both individuals and healthcare providers. Prompt action upon symptom onset can significantly enhance the effectiveness of treatment and prognosis.
2. Disease discrimination: Symptoms aid in distinguishing between different diseases. Although some illnesses may share similar symptoms, the specific combination and severity of symptoms can offer valuable insights into the underlying condition, ensuring accurate diagnosis and appropriate treatment initiation.
3. Patient-centered healthcare: Experiencing symptoms places individuals at the forefront of their healthcare journey. Through active reporting and the description of symptoms, patients provide essential information that assists healthcare professionals in comprehending the nature and progression of the disease. This patient-centric approach improves diagnostic accuracy and treatment personalization.
4. Disease progression monitoring: Symptoms serve as dynamic markers of disease advancement. Tracking symptom changes over time enables healthcare providers to evaluate treatment effectiveness, make necessary adjustments, and deliver individualized care. Symptom monitoring is particularly critical for chronic conditions requiring ongoing management.
5. Enabling targeted interventions: Specific symptoms often indicate involvement of particular organs or systems, guiding healthcare professionals towards tailored interventions. For instance, respiratory symptoms may indicate lung issues, prompting targeted investigations and treatments directed at the respiratory system. This precision in addressing symptom origins enhances therapeutic intervention efficacy.
6. Psychosocial considerations: Symptoms impact an individual’s mental and emotional well-being in addition to their physical health. Recognizing and addressing symptoms from a holistic viewpoint enables healthcare providers to consider psychosocial factors that may influence overall patient health. This comprehensive approach contributes to a patient-centered care model.

We often do not like some events that happen in our lives at first, and they can make our lives very difficult. However, as time goes by, we often see the positive outcomes of those events. A verse from the holy Qur’an explains this human condition in a very concise way: “Perhaps you dislike something which is good for you and like something which is bad for you. God knows and you do not know” (al-Baqarah 2:216). Similarly, the significance of symptoms in diseases goes beyond mere inconvenience. They act as indispensable indicators, directing healthcare professionals towards early detection, precise diagnosis, and individualized treatment. Without these symptoms as early warnings, we would not be able to understand and respond to diseases in a timely manner. Embracing a holistic understanding of symptoms empowers both patients and healthcare providers to collaborate in managing diseases effectively. Acknowledging symptoms as integral elements of both diagnosis and treatment enhances the overall standard of healthcare, fostering a thorough and patient-centered approach.

References

https://www.britannica.com/science/human-disease

https://en.wikipedia.org/wiki/List_of_medical_symptoms

Santiago V. Painful Truth: The Need to Re-Center Chronic Pain on the Functional Role of Pain. J Pain Res. 2022;15:497-512. Published 2022 Feb 16. doi:10.2147/JPR.S347780

https://en.wikipedia.org/wiki/Congenital_insensitivity_to_pain

Singh P, Yoon SS, Kuo B. Nausea: a review of pathophysiology and therapeutics. Therap Adv Gastroenterol. 2016;9(1):98-112. doi:10.1177/1756283X15618131

https://www.medicalnewstoday.com/articles/161858

https://www.cancer.gov/publications/dictionaries/cancer-terms/def/symptom

“Medical education is the process for training doctors, subordinate to the dominant economic and social structures in societies in which it takes place.” [1]

Over the last decades, we have witnessed increasing income inequality. The US is no exception. The discrepancy between upper-income and low-income households has been on the rise [2]. This, of course, manifests itself in medical education, making it accessible to only a fraction of society. Approximately 50% of medical students come from families whose incomes are in the top quintile, and 80% come from the top two quintiles. Yet, these doctors are expected to empathize with patients from lower socioeconomic status (SES) and understand the difficulties a patient must overcome before being able to step foot in a doctor’s office [3,4]. They must be able to recognize the obstacles a patient has overcome, whether that be losing money from missing work or spending hours on a bus to be seen for merely 10 minutes. Imagine going through all this trouble, only to be judged for having low medical literacy or not speaking a specific language, and then being sent home feeling your problem is unresolved. The fact that many experience this for a medication they may not be able to afford ensues further distrust in the medical establishment.

The structural issues mentioned above are present in every aspect of our healthcare system. In medicine, fee-for-service—being paid for each office visit, procedure, CT scan, etc.—is how doctors are paid. This draws a strong parallel to how medical school applicants are selected. How many hours did you volunteer, how many leadership positions did you hold, and how many test questions did you get right? Subjective measures of a student’s potential, resilience, and grit, such as if they had to support a family during the process or had to make tough decisions such as picking between MCAT test prep materials and groceries, hold little to no weight depending on the institution. Without considering such inequalities and offering bottom-up solutions to these issues, our healthcare system is likely to remain dominated by people who have difficulty empathizing with a socioeconomically diverse patient population.

Our healthcare system, however, isn’t broken—at least for some people. The structural issues work quite well for those who built the system to benefit from it. We have a very profitable “disease care system,” according to Escape Fire: The Fight to Rescue American Healthcare, a documentary that analyzes the American healthcare system and some of its underlying issues: “It doesn’t want you to die, and it doesn’t want you to get well. It just wants you to keep coming back” [5]. What incentive does a person from the top quintile have to change a system that has benefited them their entire lives? A UK study illustrated a direct association between medical student SES, academic ability, and specialty choice [6].

As noted in Escape Fire, specialized physicians are given more seats at the table than primary care physicians in health policy matters because they fund pharmaceutical and high-tech companies with the nature of how they practice medicine—reinforcing a “disease care system” [4]. Medical schools that do not prioritize socioeconomic diversity in their incoming classes will train a workforce that will likely remain complacent in a healthcare system that benefits a handful of people. It is important to note, however, that this complacency does not necessarily come from a place of ill intention—after all, we all promise to, “first, do no harm” [7]. Like the phrase, “ignorance is bliss,” when we are not exposed to something, it is less likely to be on our radar. We are less likely to even perceive issues if we are not affected by them. Integrating curriculums focused on emotional and social intelligence alongside efforts to increase diversity will no doubt spark conversation and dialogue surrounding these issues, leading to new and innovative solutions.

Thanks to various social media platforms, these apparent issues are being discussed among healthcare professionals more than ever. For instance, #medtok—the medical side of the social media app TikTok—has become a platform for such discussions. A user called @pathdoctormd asks, “When did u first realize ur friends in med school came from families that were way richer than yours?” and answers, “when a group of my friends in medical school were planning a trip to Europe during our one week of vacation for spring break”[8]. The comments include answers as well: “I only applied to the medical schools my family donated to” (@dmccooey4); “When I heard about their private jets … two different individuals had grandfathers who OWNED entire med schools. Legacies are a diff breed” (@neebsz); “My boy is in medical school and tells me similar stories. He lives on lentils and they thought he was a cool vegan … No, we are just poor” (@distractedpainter).

I had a similar experience after learning a classmate’s father had sponsored our whitecoat ceremony, and other parents sponsored rooms and various parts of the new medical school building. Even one of my classmates posted a TikTok explaining her medical school acceptance story, lacking support from advisors and applying to only six schools due to cost [9]. On October 16, 2021, @drglaucomflecken posted a video criticizing the greed of the Association of American Medical Colleges (AAMC) in the Electronic Residency Application Service (ERAS) process—again supporting how those from higher SES backgrounds may be more likely to match into more competitive specialties, getting more seats at the health policy table that will determine what the future of American healthcare will look like [10].

From the collective experiences shared in the previous paragraph, it is challenging to believe peers from higher SES can genuinely empathize with future patients—who will be strangers—when they already struggle to empathize with their medical school peers. Greater exposure to classmates from various SES is a crucial way to combat this. An unspoken power dynamic may even exist between higher SES and lower SES students, and lower SES students may not be comfortable sharing their backgrounds. Not only is increasing admissions in this population necessary but creating space for them and their stories is also non-negotiable if we’re to truly promote dialogue among peers.

Research shows “diversity among providers leads to better patient outcomes, greater attention to cultural issues in the treatment process, reductions in disparities in health outcomes and access, innovation in thought and practice, and increased satisfaction among patients” [11, 12]. Many argue that this gap is closing; however, in fact, it is actually widening for some groups. For example, low-SES are underrepresented in medicine [13, 14]. Pipeline programs and holistic criteria in the application process are missing the mark if medicine is not diversifying: “It seems impracticable that, Dr. Nakae posits, qualified potential trainees should spend thousands more dollars and hours to recuperate a few tenths of a point in their grade point averages before applying. Do the additional classes they take make them better doctors? Do they make a difference, or only deter and delay applicants?” [12].

There is a national call for more physicians, and studies have shown there is no evidence that higher MCAT scores or GPAs predict better doctors. They predict approximately 50% variance in performance in the first two years of medical school. This is one of the least considered elements of residency program applications, yet the most important factor in a medical school application [15, 16, 17].

In Escape Fire, Dr. Ornish says, “We change medical practice, we change medical education” [4]. I would add that we must also change the medical school application process, making it more accessible and affordable. This will, in turn, create a more accessible healthcare system. Consequently, a healthier society will decrease the financial burden on the state, thus making room for improving other aspects of people’s lives. Dialogue—making spaces to have discussions where these voices and concerns are heard—is the first step to developing simple yet innovative solutions to this complex issue.

I would humbly like to conclude by proposing some potential solutions:

1) Preventing the “Leaky Pipeline” phenomena, which is defined as an “early decline in interest in premedical studies among underrepresented minority undergraduate students.”

• Increasing high school programs in low-income areas to motivate students to prepare for college;
• Collaborating on grassroots efforts to fund students who are accepted into college;
• Organizing coaching and mentorship programs to continue to support and motivate students through the difficulties of college and medical school admissions. (One example of such an organization is The UpLIFT (Under-represented, Low Income and First-Time students) Project.) [18]

2) Increasing funding and support through government grants.

• Advocating for increased educational opportunities at the high school, college, and medical school levels by writing letters to Congresspeople and attending town halls in local communities.

3) Increasing transparency and accountability of medical schools and the AAMC.

• Requiring more detailed public disclosure of applicant and matriculant data in medical school and residency programs;
• Not only focusing on recruitment but also retention activities to improve access.

4) Increasing ease of access to support and resources within the medical education system.

• Funding free healthcare for students within institutions;
• Funding a variety of free mental health resources within institutions;
• Increasing spaces for discussion of topics around diversity.

5) Integrating emotional and social intelligence education in medical education curriculums.

• Allocating time within existing curriculums to train and practice emotional and social intelligence skills;
• Initiating conversations regarding cost in didactic lectures as well as clinical opportunities.

References

• Garcia JC. Características generales de la educación médica en la América Latina [General characteristics of medical education in Latin America]. Educ Med Salud. 1969;3(4):267-316.
• Horowitz, Juliana Menasce, Ruth Igielnik, and Rakesh Kochhar. “Trends in U.S. Income and Wealth Inequality.” Pew Research Center’s Social & Demographic Trends Project. Pew Research Center, August 17, 2020. https://www.pewresearch.org/social-trends/2020/01/09/trends-in-income-and-wealth-inequality/.
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Ceyda Sablak is a resident pediatrician at Tripler Army Medical Center

Everyone needs to go to the doctor at some point in his or her life. If there is a complicated medical situation, they are referred to a specialized doctor. Sometimes, general practitioners cannot make the right diagnoses. Many patients are lost between different physicians and their views on a specific case. It raises this question: is there an overspecialization problem in medicine? Is it good or bad to have so many specialties and even subspecialties? Does specialization in medicine help to get better care for patients? Does it help physicians to practice more effectively? Is there enough cooperation between physicians?

A medical specialty is a branch of medical practice that is focused on a defined group of patients, diseases, skills, or philosophies. Examples include children (pediatrics), cancer (oncology), laboratory medicine (pathology), or primary care (family medicine). After completing medical school, physicians or surgeons usually further their medical education in a specific specialty of medicine by completing a multiple-year residency to become a specialist. This is a very long and difficult process: it takes around 4-8 years to finish medical school depending on the school and country and then around 3-5 years to specialize in an area depending on the specialty.

Medical specialties can be classified by the following categories:

• Surgical or internal medicine: Surgical medicine generally means that diagnosis and treatment are achieved through major surgical techniques. In internal medicine, the main diagnosis and treatment is never major surgery.
• Age range of patients: The age range of patients seen by any given specialist can be quite variable (pediatrics, geriatrics, etc.).
• Diagnostic or therapeutic: While the diagnostic process is of great importance in all specialties, some specialists perform mainly or only diagnostic examinations, such as pathology, clinical neurophysiology, and radiology.
• Organ-based or technique-based: Many specialties are organ-based. Many symptoms and diseases come from a particular organ. Others are based mainly around a set of techniques, such as radiology, which was originally based around X-rays.

According to the American Board of Medical Specialties, there are 24 different specialties in medicine. Among these, many of them—such as internal medicine, pediatrics, family medicine, dermatology, etc.—have subspecialties. For example, internal medicine has 22 subspecialty areas, and pediatrics has 20 subspecialties. Even some of the doctors who have been specialized in these subspecialties have been specialized in more specific areas like an internal medicine doctor who has been specialized in cardiology and then specialized in cardiac arrhythmias. 

In the past, there weren’t as many specialist doctors, but specialist-driven care has now become a fact of medical practice. In the past decade, the probability that a visit to a physician resulted in a referral to a specialist has nearly doubled, from 5% to more than 9%. Referral rates to specialists are estimated to be at least twice as high in the U.S. as in Britain.

The past half-century has witnessed great changes in American medicine. One of the biggest shifts is this rise of specialists. In 1940, three-quarters of America’s physicians were general practitioners. By 1960, specialists outnumbered generalists, and by 1970 only a quarter of doctors counted themselves general practitioners. There are a multitude of factors causing the increase in specialization, like earning potential, quality of life, and prestige.

Patients with multiple chronic diseases are not an anomaly, and the number of the patients who have more than one disease has been increasing. One of the main causes for the increasing number of patients is because we now have more effective diagnostic techniques. Recently, a group of researchers in Scotland examined the healthcare usage of 1.7 million people, nearly a third of the country. Their findings, published in the prestigious medical science journal The Lancet, suggest that 23% of Scottish people have multimorbidity, roughly the same percentage as in the United States, and that this percentage increases drastically as people age.

By age 65, the average person has two or more chronic diseases, and people living in poverty reach this mark nearly 10 years earlier. As both the percentages of the population living in poverty and over 65 years of age continue to rise, handling patients with multiple chronic ailments become more complicated and requires more specialists.

The researchers looked for differences in treatment and outcomes among Medicare patients hospitalized for heart attack, heart failure, or cardiac arrest when the American Heart Association and American College of Cardiology held their national meetings compared with identical non-meeting dates. Their retrospective data set spanned 10 years (2002 to 2011). They found “substantially” lower adjusted 30-day death rates among high-risk patients with heart failure or cardiac arrest admitted to teaching hospitals during meeting dates. For heart failure, the death rate was 17.5% during meeting times vs 24.8% during non-meeting times. For cardiac arrest, the rates were 59.1% and 69.4%, respectively. For high-risk patients admitted to teaching hospitals with acute myocardial infarction, 30-day mortality rates were similar between meeting and non-meeting dates, at 39.2% and 38.5%. Fewer PCIs (Percutaneous Coronary Intervention—formerly known as angioplasty with stent) were performed during meeting dates (20.8% vs. 28.2%), “without any detriment to survival,” a finding that “suggests potential overuse of PCI in this population,” the authors said in a paper released online on December 22 in JAMA Internal Medicine.

Some researchers resemble the health care system to the “pin factory” model of Adam Smith. According to this model, which Smith tells in an anecdote on the first page of his The Wealth of Nations, the division of labor is the main cause of prosperity. He asserted that ten workers could produce 48,000 pins per day if each of eighteen specialized tasks was assigned to particular workers. Average productivity would be 4,800 pins per worker per day. Without the division of labor, a worker can hardly produce even one pin per day. This example shows the increased productivity and effectiveness after specialization.On the other hand, we also need to see the whole picture especially regarding patients with multiple medical conditions. Otherwise, as in the parable of the blind men and the elephant, we can have only partial diagnosis and cannot provide patients with a wholesome healing.Fethullah Gülen, a contemporary Islamic intellectual, said that the profession of medicine is very important, and it is one of the best and most direct ways to help people and earn God’s pleasure. He also points out the problem of being lost in medical specialization: “We cannot look at a person by separating heart, head, or nervous system from one another… The organism is a whole, and each organ is in connection with the other. Then we need to take a wholistic look – a heart doctor should know the other parts of the body as well as the heart so that she/he can reach more accurate conclusions.”

Information in the medical arena is growing very fast, and technology is rapidly changing. As the technology develops, new techniques are being introduced in thousands of medical publications. It is impossible for doctors to keep up with all of these developments. But they are in a position to evaluate the standards of practice, review advances in technology and science—and changes in regulation and delivery systems—and adapt themselves accordingly. Physicians have to be supported throughout their careers with innovative programs that help early-career physicians further research, connect physicians with emerging scientific studies, and practice relevant continuing medical education, as well as recognizing the work physicians are doing to improve health care safety and quality.

In conclusion, specialization in medicine is very important, but this specialization should not turn into a form of alienation from other departments, and doctors should not miss the general points. They must work in coordination with other doctors through extensive consultation.

References

• Cambridge University Press. (2009). Cambridge academic content dictionary, 2
• https://www.econlib.org/library/topics/highschool/divisionoflaborspecialization.html
• https://en.wikipedia.org/wiki/Medical_specialty
• https://www.abms.org/wp-content/uploads/2020/11/ABMS-Guide-to-Medical-Specialties-2020.pdf
• 2018 May; 10(5): e2720. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6067811/
• https://www.theatlantic.com/health/archive/2012/07/our-unsustainable-culture-of-medical-specialization/260504/
• https://www.herkul.org/kirik-testi/husn-u-zan-ve-rahmete-iltica/

What is a vaccine?

A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. The first vaccine was introduced by British physician Edward Jenner in 1796, who used the cowpox virus (vaccinia) to confer protection against smallpox, a related virus, in humans.

A vaccine typically contains an agent that resembles a disease-causing microorganism. It is often made from weakened or killed forms of the microbe, its toxins, or one of its proteins. Vaccines stimulate the body’s immune system to recognize the agent as a threat and destroy it. When the virulent version of an agent is encountered the body recognizes the protein coat on the virus and is prepared to respond. It first neutralizes the target agent before it can enter cells and then recognizes and destroys infected cells before that agent can multiply to vast numbers.

The administration of vaccines is called vaccination, and it is so far the most effective method of preventing infectious diseases. Vaccines help the body to produce antibodies, which are the human body’s defensive cells that fight off any foreign substances. We can produce antibodies on our own, but some infections, including mild ones like chickenpox, can cause some people to get very sick and die before enough antibodies are produced. Vaccination helps our bodies be prepared by “imitating” an infection so that antibodies can be formed before the infection gets deadly.

Vaccines for several diseases have been very successful and provided widespread immunity due to worldwide vaccination. For example, smallpox was eradicated by worldwide vaccination and several others such as polio, measles, and tetanus have been brought under control. The effectiveness of vaccination has been widely studied and verified. Some other vaccines including influenza, HPV, and chickenpox have been proven to be effective. The World Health Organization (WHO) reports that licensed vaccines are currently available for twenty-five different preventable infections.

In the 1950s, before polio vaccines were available, polio caused more than 15,000 cases of paralysis each year in the United States. Following the introduction of vaccines, trivalent inactivated poliovirus vaccine in 1955 and trivalent oral poliovirus vaccine in 1963, the number of polio cases fell rapidly to less than 100 in the 1960s and fewer than 10 in the 1970s. Vaccination has also reduced the number of measles infections by more than 99 percent. As well as preventing the spread of infection and protecting the people, vaccines also help prevent the development of antibiotic resistance.

Some vaccines require a second dose in order to build up a strong enough immunity, such as MMR vaccines for Covid-19. Others, such as the tetanus vaccine, require a “booster shot” after a certain amount of time because the immunity of the first vaccine decreases over time. In the case of the flu, the main targets of the immune response may change slightly from year to year depending on which flu virus strains are circulating most that year thus often requiring a new vaccine every year.

Vaccine types

Vaccines typically contain dead or inactivated organisms or purified products derived from these organisms. There are several types of vaccines in use each of which represent different strategies to reduce the risk of illness while retaining the ability to induce a beneficial immune response.

They contain either:

1. A weakened (attenuated) form of a pathogen.
2. An inactivated form of a pathogen.
3. Certain parts of a pathogen, such as its proteins.
4. A weakened toxin made by the pathogen.

Attenuated vaccine: Some vaccines contain live, attenuated microorganisms. Many of these are active viruses that have been cultivated under conditions that disable their virulent properties or closely related but less dangerous organisms used to produce a broad immune response.

Attenuated vaccines have some advantages and disadvantages. Attenuated, or live, weakened vaccines typically provoke more durable immunological responses. But they may not be safe for use in individuals with weak immunity. These vaccines may rarely mutate to a virulent form and cause disease.

Inactivated vaccine: Some vaccines contain inactivated, but previously virulent, micro-organisms that have been destroyed with chemicals, heat, or radiation. The vaccines for polio, hepatitis A, and rabies, as well most influenza vaccines are good examples of this type.

Toxoid vaccine: Toxoid vaccines are made from inactivated toxic compounds that cause illness rather than the micro-organism. Examples of toxoid-based vaccines include tetanus and diphtheria vaccines.

Subunit vaccine: Rather than introducing an inactivated or attenuated micro-organism to an immune system, a subunit vaccine uses a fragment of it to develop an immune response (hepatitis B, human papillomavirus vaccine).

Conjugate vaccine: Some bacteria have a polysaccharide outer coat that is poorly immunogenic. These outer coats are linked to toxoid proteins and the immune system is led to recognize the polysaccharide as if it were a protein antigen. This approach is used in the Haemophilus influenzae type B vaccine.

Outer membrane vesicle vaccines: Outer membrane vesicles are naturally immunogenic and can be manipulated to produce potent vaccines. Serotype B meningococcal disease vaccines are good example to this type.

Heterologous vaccines (Jennerian vaccines): These are vaccines that are pathogens of other animals that either do not cause disease or cause mild disease in the organism being treated. The classic example is Jenner’s use of cowpox to protect against smallpox. A current example is the use of BCG vaccine made from Mycobacterium bovis to protect against tuberculosis.

Viral vector vaccines: These vaccines use a safe virus to insert pathogen genes in the body to produce specific antigens, such as surface proteins, to stimulate an immune response.

RNA vaccines: An mRNA vaccine (or RNA vaccine) is a novel type of vaccine which is composed of the nucleic acid RNA packaged within a vector such as lipid nanoparticles. Many vaccines put a weakened or inactivated germ into our bodies to trigger an immune response. But instead, mRNA vaccines teach our cells how to make a protein or even just a piece of a protein that triggers an immune response inside our bodies. Among the COVID-19 vaccines are a number of RNA vaccines under development to combat the COVID-19 pandemic and some have received emergency use authorization in most countries.

Other contents of a vaccine

A vaccine dose contains many ingredients, very little of which is the active ingredient called the immunogen. Other ingredients are added to boost the immune response, to ensure safety or help with storage, and a tiny amount of leftover material from the manufacturing process. These materials can very rarely cause an allergic reaction in people who are very sensitive to them.

Adjuvants: Vaccines typically contain one or more adjuvants which are used to boost the immune response. This presents the antigen in such a way as to produce a greater action than the simple aqueous tetanus toxoid.

Preservatives: Vaccines may also contain preservatives to prevent contamination with bacteria or fungi.

Excipients: Beside the active vaccine itself, some excipients and residual manufacturing compounds are present or may be present in vaccine preparations (e.g. aluminum salts or gels antibiotics, egg proteins, formaldehyde monosodium glutamate). These are added to some vaccines to prevent the growth of bacteria during production and storage of the vaccine.

Vaccine licensing

A vaccine can be licensed after the successful conclusion of the development cycle and further successful clinical trials. Clinical Phases I–III are necessary for licensing and safety, immunoactivity, immunogenetic safety at a given specific dose should be demonstrated. Also, the effectiveness in preventing infection for populations that will be vaccinated should be proven. For each vaccine the time endurance or need for revaccination must be estimated. Vaccine manufacturers do not receive licensing until a complete clinical cycle of development and trials proves the vaccine is safe and has long-term effectiveness. Then, it has to be reviewed and licensed by a multinational or national regulatory organization.

Vaccination failure or adverse effects

Sometimes protection with vaccines fails because of failures in vaccine attenuation. It may be related with the host’s immune system as it simply does not respond adequately or at all. Lack of response commonly results from genetics, immune status, age, health, or nutritional status. Sometimes the host develops antibodies but the protection might not be adequate; immunity might develop too slowly to be effective in time; or the antibodies might not disable the pathogen completely. Additionally, there might be multiple strains of the pathogen not all of which are equally susceptible to the immune reaction. But even in this case, a partial, late, or weak immunity, may mitigate an infection and result in a lower death rate, milder complications from an infection, or faster recovery.

Vaccinations given to children, adolescents, or adults are considered safe. They may cause generally mild adverse effects. Some common side effects include fever, pain around the injection site, and muscle aches. Additionally, some individuals may be allergic to ingredients in the vaccine. Such reactions are exceptionally rare occurring in less than one in a million people for most vaccines. Severe reactions also tend to affect only certain populations such as persons whose immune systems are compromised by preexisting disease (e.g., HIV/AIDS) or who are undergoing chemotherapy.

Do vaccines cause autism?

Claims have been made that vaccines are responsible for certain adverse health conditions, particularly autism, speech disorders, and inflammatory bowel disease. Some of those claims focused on thimerosal, a mercury-containing compound used as a preservative in vaccines.

Thimerosal is a mercury-containing antimicrobial that is added to vials of vaccines that contain more than one dose to prevent contamination and growth of potentially harmful bacteria. Some people believed that autism was a form of mercury poisoning and was caused specifically by thimerosal in childhood vaccines. But those claims have been discredited. Because of all these accusations against thimerosal, it has been removed from most vaccines except multi-use influenza. Even in these vaccines, it was reduced to levels so that a single dose contained less than a microgram of mercury, a level similar to eating ten grams of canned tuna.

Misinformation and fear generated by false claims about associations between autism and vaccines had a significant impact on people regarding vaccine safety especially for kids. But in reality, most people in countries where vaccination is widespread have never experienced vaccine preventable diseases. In this case, the focus of concern for some people changed from the negative effects of vaccine preventable disease to the possible negative effects of the vaccines themselves.

Some concerns over the effects of vaccination led to decreasing levels of vaccination coverage in some areas of the world. As a result, not only were individuals susceptible to vaccine-preventable diseases, vaccination rates dropped low enough to cause losses of herd immunity thereby allowing outbreaks of disease.

Normally, germs can travel quickly through a community and make a lot of people sick. If enough people get sick it can lead to an outbreak. But when enough people are vaccinated against a certain disease, “herd immunity, aka community immunity, is formed and it becomes harder for that disease to spread to others. Community immunity is especially important for people who cannot get certain vaccines. For example, they may not be able to get a vaccine because they have weakened immune systems. Others may be allergic to certain vaccine ingredients. Newborn babies are too young to get some vaccines. Community immunity can help to protect vulnerable populations such as these ones.

If there are outbreaks of disease because of the lack of enough vaccination outbreaks may bring high costs to countries, especially in terms of health and medical care, economic strain, and loss of life. All of the world experienced this with the lack of a vaccine for COVID-19 disease in the first year of the virus’ spread.

Some people reject certain drugs or treatment methods on the grounds that they are not halal or kosher and do not comply with their beliefs. Prophet Muhammad (peace be upon him) said that “God did not send down a disease without having sent down its cure.” This Prophetic statement indicates that there are remedies for every disease yet to be discovered by scientists. Many religious scholars rule that certain things that are forbidden under normal circumstances can be allowed in times of need, which in this case is the danger of death or the risk for loss of any organ. This rule should direct faithful scientists to work harder to find drugs or therapeutic methods that fit their beliefs.

In conclusion, vaccines protect our communities through collective immunity. The World Health Organization (WHO) estimates that immunization prevents between 2 to 3 million deaths each year. Ending vaccination could be very dangerous. Even in the 21st century, many vaccine-preventable deaths still occur because vaccines are not available to everyone. One of the missions of the World Health Organization is to increase vaccine availability to everyone including poor countries.

References

• https://www.infoplease.com/math-science/health/healthcare/vaccines
• https://health.clevelandclinic.org/vaccine-faqs-how-are-vaccines-developed-and-how-do-they-work/
• https://medlineplus.gov/vaccines.html
• https://www.healthline.com/health/vaccinations#if-we-stopped
• https://www.britannica.com/science/vaccine/Benefits-of-vaccination
• https://en.wikipedia.org/wiki/Vaccine

A pandemic (from Greek, pan, “all” and demos, “people”) is an epidemic of an infectious disease that has spread across a large region, for instance multiple continents or worldwide, affecting a substantial number of people. A pandemic is an epidemic occurring on a scale that crosses international boundaries, usually affecting people on a worldwide scale. A disease or condition is not a pandemic merely because it is widespread or kills many people; it must also be infectious. For instance, cancer or other chronic diseases such as diabetes or hypertension are responsible for many deaths, but they are not considered a pandemic because the disease is neither infectious nor contagious.

How about the solutions to the pandemic? While protective measures at the individual level are crucial, real solutions come with collective action. Pandemics affect “all people,” so should the solutions be. “Every sheep is hung by its own leg,” says the Turks, meaning that everyone pays for their own mistakes, not for the mistakes of others. In the case of pandemics, mistakes are paid for by all. Nevertheless, when the threat is big and resources are limited, individuals, as well as nations, may choose to act on their own instead of globally.

There is a tale which gives many lessons to us based upon this proverb. Bahlul Dana was a well-known judge and scholar who lived at the time of the mighty Caliph Harun al-Rashid. Bahlul advised people to avoid doing wrong things and invited everyone to be kind and wise. Some people did not like his warnings and they went to Harun al-Rashid. They complained about Behlul Dana and said that “My sultan, tell him to leave us alone and not to warn about everything. Each sheep is hung by its own leg.” Upon these complaints, Harun al-Rashid summoned him to his court and warned him not to disturb people with his warnings. Bahlul Dana left the palace without saying anything. He slaughtered a few sheep and hung them from their legs on a corner of the street and told people not to touch them. As days passed, the hanging carcasses started smelling very bad. When the smell became unbearable, the same people went to Harun al-Rashid again. “We cannot stop the smell of the sheep Bahlul hung. It bothers us very much. Tell him to dispose of them!”

Harun al-Rashid wondered why Bahlul did such a thing. “Bahlul, why did you do such a strange thing? He answered: “I did not do anything. I just hung each sheep by its own leg. But it seems that even if each sheep is hung by its own leg, it still disturbs the whole environment and harms everyone. A villain does not hurt only himself; he harms everyone.”

The story gives an important lesson: Sometimes the consequences of our ignorance and selfish behaviors may harm other people first, and we may choose to ignore them; however, as selfish as it is, we rarely can do away with selfish behaviors, not least when the consequences are global as in a pandemic. When we look at the pandemics throughout the history, we can see the same perspective. During human history, there have been a number of pandemics which have affected millions of people and which probably could have been curbed if people could have acted collectively.

Pandemics in history

Antonine Plague (165 AD): The Antonine Plague (Plague of Galen) was an ancient pandemic that affected Asia Minor, Egypt, Greece, and Italy, and is thought to have been either Smallpox or Measles. This unknown disease, which was brought to Rome by soldiers returning from Mesopotamia around 165 AD, was the cause of high death toll: 5 million people dead and the Roman army was literally decimated.

Justinian Plague (541-542): The Plague of Justinian was an outbreak of the bubonic plague that affected the Byzantine Empire and Mediterranean port cities. It was carried over the Mediterranean Sea from Egypt. The plague decimated Constantinople and spread like wildfire across Europe, Asia, North Africa and Arabia, killing an estimated 25 to 100 million people, perhaps half of the world’s population. It was spread was by infected fleas and perhaps body lice. Its mortality rate was around 10% with treatment, up to 90% without.

The Black Death (1346-1353): Another outbreak of Plague was seen in Europe, Africa, and Asia, with an estimated death toll between 75 and 200 million people between 1346-1353. In the 14th century the world’s population was estimated to be 443 million. That means the Black Death killed between 17-45% of the entire global population. This plague is estimated to have resulted from the increased rat populations and fleas.

Ports were major urban centers at the time and they were the perfect breeding ground for these rats and fleas. To stop the spreading of the disease in the Venetian-controlled port city of Ragusa, they decided to keep newly arrived sailors in isolation until they could prove that they weren’t sick.

At first, sailors were held on their ships for 30 days, which became known in Venetian law as a trentino. The Venetians increased the forced isolation to 40 days or a quarantino, which is the origin of the word “quarantine” after which its practice started in the Western world.

Third Cholera Pandemic (1852–1860): There have been seven cholera pandemics in history and the third cholera pandemic has been considered the deadliest one. It lasted from 1852 to 1860 and it originated from India, spreading from the Ganges River Delta to Asia, Europe, North America and Africa. Around one million people died during this pandemic.

Flu Pandemic (1889-1890): The “Asiatic Flu” or “Russian Flu” was thought to be an outbreak of the Influenza A virus subtype H2N2 or Influenza A virus subtype H3N8, which are subtypes of influenza A viruses. These viruses are divided into subtypes on the basis of two proteins; hemagglutinin (HA) and neuraminidase (NA), which are present on the surface of the virus. There are 18 known HA subtypes and 11 known NA subtypes. Many different combinations of HA and NA proteins are possible and different subtypes of influenza viruses caused many pandemics during history.

The first cases of this pandemic were observed in 1889 in three separate and distant locations: Bukhara in Central Asia (Turkestan), Athabasca in northwestern Canada, and Greenland. Rapid population growth of the 19th century in urban areas helped the spread of the flu, resulting a death toll of about one million people.

Sixth Cholera Pandemic (1910-1911): It originated in India and killed over 800,000 people. It had spread to the Middle East, North Africa, Eastern Europe and Russia. It was the last American outbreak of cholera between 1910–1911. American health authorities quickly took precautions and isolated the infected. By the end of the pandemic, only 11 deaths occurred in the US, which showed the importance of precautions and preparedness.

Spanish Flu (1918): Between the spring of 1918 and the summer of 1920, a deadly outbreak of influenza tore across the globe, infecting over a third of the world’s population (500 million) and ending the lives of 30-50 million people. The mortality rate was estimated at 10% to 20%, with up to 25 million deaths in the first 25 weeks alone. It was caused by the H1N1 influenza A virus and transmitted by airborne transmission from coughing, sneezing, and breathing. Although previous flu pandemics killed juveniles, the elderly or already weakened patients, Spanish flu affected completely healthy young adults. Modern advancements in transportation and troop movements during World War One helped its spread. The true origin of the virus could be France, England, China, and the United States and it is estimated that the virus originated in birds, and either jumped to humans directly or used pigs as an intermediary before jumping to humans.

Asian Flu (1956-1958): It originated in China in 1956 and lasted until 1958. In these two years, the Asian Flu traveled from the Chinese province of Guizhou to Singapore, Hong Kong, and the United States. It was a pandemic of Influenza A of the H2N2 subtype and World Health Organization believe it caused approximately 2 million deaths, around seventy thousand in United States alone.

Hong Kong Flu (1968): The flu pandemic in 1968 was caused by the H3N2 strain of the Influenza. The first case was reported on July 13th, 1968 in Hong Kong, and it took only 17 days before outbreaks of the virus were reported in Singapore and Vietnam. Only after three months it was seen in the Philippines, India, Australia, Europe, and the United States. Although it had a low mortality rate (0.5%), it still resulted in the deaths of more than a million people, including 500,000 residents of Hong Kong, approximately 15% of its population at the time.

Recent pandemics

Swine flu (2009-2010): It was an infection caused by one of several types of swine influenza viruses. This virus is any strain of the influenza family of viruses that is endemic in pigs. Transmission of the virus from pigs to humans is not common and does not always lead to human flu, often resulting only in the production of antibodies in the blood. If transmission does cause human flu, it is called zoonotic swine flu. People with regular exposure to pigs are at increased risk of getting infected by swine flu.

It is estimated that in the 2009 flu pandemic, there were 18,449 confirmed fatalities from swine flu. However, in a 2012 study, the Center for Disease Control (CDC) estimated more than 284,000 possible fatalities worldwide, with a range from 150,000 to 575,000 deaths. In August 2010, the World Health Organization declared the swine flu pandemic officially over.

Severe Acute Respiratory Syndrome (SARS): It is a viral respiratory disease caused by a SARS-associated coronavirus. SARS was first reported in Asia in February 2003. The illness spread to more than two dozen countries in North America, South America, Europe, and Asia before it was contained the same year.

SARS is an airborne virus and can spread through small droplets of saliva in a similar way to the cold and influenza. It was the first severe and readily transmissible new disease to emerge in the 21st century and showed a clear capacity to spread along the routes of international air travel. SARS can also be spread indirectly via surfaces that have been touched by someone who is infected with the virus.

Most patients identified with SARS were previously healthy adults aged 25–70 years. A few suspected cases of SARS have been reported among children under 15 years. The case fatality among persons with illness for probable and suspected cases of SARS is around 3% and 770 people died from SARS. No cases of SARS-CoV have been reported worldwide since 2004. As of 2020, SARS is considered eradicated in humans, but considering that the virus also infects animals it is possible that it will re-emerge in the future.

Ebola Virus Disease (EVD): EVD is a rare and deadly disease seen in humans and animals like bats, monkeys, gorillas, and chimpanzees. It is caused by viruses located mainly in sub-Saharan Africa. People can get EVD through direct contact with an infected animal or a sick or dead person infected with Ebola virus.

The disease was first identified in 1976, in two simultaneous outbreaks: one in South Sudan and the other Democratic Republic of the Congo. EVD outbreaks occur intermittently in tropical regions of sub-Saharan Africa. From 1976 to 2012, the World Health Organization reports 24 outbreaks involving 2,387 cases with 1,590 deaths. The largest outbreak to date took place in West Africa from December 2013 to January 2016, with 28,646 cases and 11,323 deaths. It was declared no longer an emergency on 29 March 2016.

Middle East Respiratory Syndrome (MERS): It is an illness caused by a virus (more specifically, a coronavirus) called Middle East Respiratory Syndrome Coronavirus (MERS-CoV). It is a virus transferred to humans from infected dromedary camels (zoonotic virus). It is contactable through direct or indirect contact with infected animals. MERS-CoV has been identified in dromedaries in several countries in the Middle East, Africa, and South Asia. Health officials first reported the disease in Saudi Arabia in September 2012. A total of 27 countries have reported cases since 2012, leading to 858 known deaths due to the infection and related complications. About 3 or 4 out of every 10 patients reported with MERS have died.

Zika: Zika virus is a mosquito-borne flavivirus that was first identified in Uganda in 1947 in monkeys. It was later identified in humans in 1952 in Uganda and Tanzania. From 2007 to 2016, the virus spread eastward, across the Pacific Ocean to the Americas, leading to the 2015–2016 Zika virus epidemic. In 2015, and strongly intensified throughout the start of 2016, with more than 1.5 million cases across more than a dozen countries in the Americas. The World Health Organization warned that Zika had the potential to become an explosive global pandemic if the outbreak was not controlled. Zika is spread mostly by the bite of an infected mosquito. Zika can be passed from a pregnant woman to her fetus, and an infection during pregnancy can cause certain birth defects. There is no vaccine or medicine for Zika yet but there are several clinical trials going on.

Ongoing pandemics

Although we are primarily focused on the COVID-19 pandemic nowadays, there is another major pandemic that has been going on for many years.

HIV/AIDS: HIV originated in Africa and spread to the United States via Haiti between 1966 and 1972. AIDS is currently a pandemic in Africa, with infection rates as high as 25% in southern and eastern Africa. In 2006, the HIV prevalence among pregnant women in South Africa was 29%. Currently there are between 31 and 35 million people living with HIV, the vast majority of those are in Sub-Saharan Africa, where 5% of the population is infected (21 million people).

Since its clinical discovery in 1981, approximately 32 million people died from HIV/AIDS – around 865,000 people on average each year – ranking it as the fourth-leading cause of death. Although extensive research on HIV has been conducted there is unfortunately no vaccine yet.

COVID-19: Coronaviruses have been known to exist for many years, but a new strain of coronavirus was first identified in the city of Wuhan, China, in December 2019. It has caused a cluster of cases of an acute respiratory disease, which is referred to as coronavirus disease 2019 (COVID-19). It was characterized as a pandemic by the World Health Organization on March 11^th, 2020. As of February 26, 2021, more than 113 million people were infected and nearly 2,5 million people lost their lives.

When COVID-19 first started, it spread rapidly worldwide within months between people because no one on earth had any immunity to Covid-19. It was a novel virus that took the entire world by storm. Now after a full year, and after a number of vaccines have been introduced by the end of 2020, many nations still impose measures like social distancing and stay-at-home orders as schools and businesses are mostly closed.

Although several vaccines are in the market and have started to be administered, it is still hard to predict the consequences of this pandemic at the time of writing this article. But we can learn from pandemics in history to determine our best courses. The main goal is to achieve herd immunity, which means that enough people in a community are protected from getting a disease because they have already had the disease or they have been vaccinated. Herd immunity makes it difficult for the virus to spread from person to person, and it even protects those who cannot be vaccinated, like newborns. The percentage of people who need to have protection in order to achieve herd immunity varies from disease to disease, and at this point we still don’t know this percentage for COVID-19 – this means we may have long way to go.

Every shortcoming or failure to comply with measures only brings more harm towards our collective health. We have to keep in mind that we are living in a global world that is akin to a village now. National crisis plans are not enough, and international collaborative plans should be available for the management of any pandemic. Nations need to collaborate by taking precautions jointly, and countries who are under the heavy effects of the pandemic should be supported. A fair distribution of vaccines or other possible treatment options is necessary. We can overcome this type global threats if we can act collectively with all nations.

• WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China”. WHO. 31 December 2019. Retrieved 12 March 2020.
• Stawicki, Stanislawp; et al. (2020). “The 2019–2020 novel coronavirus (Severe acute respiratory syndrome coronavirus 2) pandemic: A joint american college of academic international medicine-world academic council of emergency medicine multidisciplinary COVID-19 working group consensus paper”. Journal of Global Infectious Diseases. 12 (2): 47–93. doi:4103/jgid.jgid_86_20
• https://www.worldometers.info/coronavirus/
• https://en.wikipedia.org/wiki/Pandemic
• https://www.visualcapitalist.com/history-of-pandemics-deadliest/