Team JGJ

Oct 26, 2024 New Delhi: Union Health Minister J P Nadda launched five Department of Health Research-Indian Council of Medical Research (DHR- ICMR) health research initiatives planned under the 100 days agenda here on Friday. One of the key initiatives launched is the ‘First in the World’ Challenge, inspired by the success of Chandrayaan-3, according to a statement. These initiatives aim to propel India to the forefront of global health research and innovation, aligning with the nation’s vision of a Viksit Bharat. “These ground-breaking initiatives exemplify our commitment to a healthier and more self-reliant India. By fostering indigenous innovation and investing in advanced research, we are equipping our nation to tackle pressing health challenges effectively,” Nadda said. Dr Rajiv Bahl, Secretary DHR and DG ICMR, said, “Initiatives like the ‘First in the World’ Challenge will empower our scientists and innovators to develop cutting-edge technologies that can benefit not just India but the entire world. We are committed to fostering an environment where research thrives, ultimately leading to improved health outcomes and a stronger global standing in medical research for our nation.” The statement said this high-risk, high-reward research and development scheme is designed to foster the creation of health technologies that are unprecedented globally. The programme will fund projects at various stages from proof of concept design to prototype and final product development. Additionally, under the Pradhan Mantri Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), ICMR is upgrading existing Viral Research and Diagnostic Laboratories (VRDLs) to Infectious Disease Research and Diagnostic Laboratories (IRDLs). This enhancement includes bacteriology, mycology and parasitology, expanding diagnostic capabilities beyond virology. These laboratories will strengthen India’s capacity for comprehensive surveillance and rapid response to infectious diseases, it said. ICMR also launched the ICMR Data Repository, a centralised, secure and accessible platform of high-quality datasets, ensuring data integrity and privacy. Moreover, ICMR is initiating efforts to develop drugs for rare diseases, focusing on affordable and effective therapies for conditions such as Gaucher Disease, Sickle Cell Disease and others, it said. Ongoing projects range from clinical trials to animal studies and design phases, aiming to reduce dependence on imported treatments and improve accessibility for patients in India, the statement said. Source: Economic Times

Oct 21, 2024 The Goods and Services Tax on premiums paid by senior citizens for health insurance and premiums paid by all for term life insurance may be exempted as most members of a ministerial panel set up specifically to study this agreed in favour of extending such relief on Saturday. Separately, the Group of Ministers (GoM) on rate rationalisation also discussed Saturday a GST rejig for several items and proposed cutting rates for some items such as packaged water above 20 litres (5 per cent from 18 per cent), bicycles priced less than Rs 10,000 (5 per cent from 12 per cent) and exercise notebooks (5 per cent from 12 per cent). Shoes above Rs 15,000 and wrist watches above Rs 25,000 are likely to be shifted to the topmost slab of 28 per cent GST from 18 per cent now, a state finance minister said. This rate rejig exercise will help the states and Centre to realise revenue gain of Rs 22,000 crore, which will help cover the revenue loss from reduction in GST rates for insurance premiums and other items, the minister said. For the insurance sector, GST on term life insurance premiums are likely to be exempted for all persons, including plans that consist of family members. Health insurance premium paid by senior citizens irrespective of coverage would also be exempted. For other citizens, health insurance cover till Rs 5 lakh is likely to be exempted and the existing rate of 18 per cent will be charged for health insurance cover over Rs 5 lakh. “Every GOM member wants to give relief to people. Special focus is on senior citizens. We will submit a report to the Council. Work is being done to reduce the GST rate from 18 per cent, exemption will be given for certain categories (of insurance premium). The final decision will be taken by the GST Council,” Bihar Deputy Chief Minister Samrat Choudhary, who is the convenor of both the GoMs on insurance and rate rationalisation, said after the two meetings. In its 54th meeting held on September 9, the GST Council had broadly converged on the need to reduce the tax rate for health and life insurance premiums from 18 per cent but the specific proposal was referred to the GOM on life and health insurance premium for further discussion. The existing six-member GOM on rate rationalisation was expanded to form a 13-member GOM on life and health insurance premium with the mandate to submit their report by October-end. The GST Council will meet in November to take a final decision on the rate recommendations by both the GoMs. “There were discussions held in the meeting. Most states are on board for exempting term life insurance premium from GST. Term life insurance plans which include family members are also going to be exempt. For health insurance, total relief would be given for insurance premiums paid by senior citizens and exemption would be given for health insurance cover up to Rs 5 lakh for others. The existing 18 per cent GST rate will be retained for health insurance cover above Rs 5 lakh,” a state finance minister, who is a member of the GOM, said after the meeting on Saturday. The revenue implication of the exemption proposal for senior citizens for health insurance is expected to be around Rs 2,200 crore and Rs 200 crore for exemption to term cover premiums. The revenue loss is going to be offset by gains of around Rs 22,000 crore from the proposed hike in rates on several high-end items, sources said. Rate rationalisation was discussed in the second meeting of the GOM that included rate changes for several common-use items such as packaged water, bicycles and exercise notebooks. The broad consensus was to provide relief on consumer goods and charge a higher rate for items with premium value. The GoM has proposed a reduction in the GST rate for packaged drinking water bottles above 20 litre to 5 per cent instead of 18 per cent at present. Bicycles costing less than Rs 10,000 are likely to be charged 5 per cent GST as against 12 per cent at present, whereas GST on exercise books may get reduced to 5 per cent from 12 per cent. The GoM on rate rationalisation will continue to discuss proposals for rate rejig including merger of slabs, another state finance minister said. “Rate rationalisation is an ongoing process. Several items of common use have been discussed. More discussions are pending, especially for demerit goods in the 28 per cent slab and for items which were reduced earlier from the 28 per cent slab to 18 per cent or 12 per cent,” the minister said. In December 2018, the GST Council had reduced rates for several items in the 28 per cent slab including movie tickets priced above Rs 100, television screens and monitors up to 32 inches, digital cameras, video games consoles and power banks with lithium-ion batteries. Items such as dishwashing machines, pan masala, cigarettes, air conditioners, cars, and aircrafts for personal use continue to be in the 28 per cent slab. The decision to reduce GST on insurance premiums has come after several Opposition leaders raised the issue of high tax on premiums. Opposition leaders including Leader of Opposition in Lok Sabha Rahul Gandhi Trinamool Congress chief Mamata Banerjee have demanded withdrawal of GST on life and health insurance premiums. Banerjee had also written a letter to Union Finance Minister Nirmala Sitharaman for rollback of GST on life insurance and health insurance premiums. Earlier on July 28, Union Minister of Road Transport and Highways Nitin Gadkari wrote to Finance Minister Sitharaman, saying GST on life and medical insurance premiums amounted to taxing the “uncertainties of life”. Sitharaman had said in August that tax was levied on insurance premiums even before the imposition of GST and that GST revenues are shared between states and the Centre. In 2023-24, the Centre and states had collected Rs 8,262.94 crore through

Oct 18, 2024 The Patient Safety and Access Initiative of India Foundation (PSAIIF) has filed a Public Interest Litigation (PIL) in the Delhi High Court, raising concerns about the growing trend of refurbished medical equipment imports in India. The petition highlights the significant risks posed to patient safety and questions the reliability of these devices. PSAIIF pointed out that the illegal import of refurbished medical devices, such as CT scanners, MRI machines, ultrasound equipment, and surgical robotics, threatens the integrity of India’s healthcare system. In compliance with the directions issued by the Delhi High Court, PSAIIF recently received responses from the Directorate General of Health Services (DGHS) and the Ministry of Environment, Forest, and Climate Change (MoEFCC). The responses address the issues surrounding the unauthorised import of refurbished medical equipment without appropriate certifications. This trend compromises the safety standards set under the Medical Device Rules, 2017, which are designed to ensure that only safe and effective medical devices enter the market. India has seen an increase in the import of refurbished medical devices without necessary approvals, with associations such as AiMeD and FICCI, along with several domestic companies, urging the government to take action. They argue that these imports undermine the country’s self-reliance and pose potential risks to patients. The illegal importation of refurbished devices, including high-end and high-value (HEHV) medical equipment, has been a focus of the PIL filed by PSAIIF. The petition names several respondents, including the Central Board of Indirect Taxes and Customs, DGHS, MoEFCC, DGFT, and Intuitive Surgical India Pvt Ltd. Professor Bejon Kumar Misra, the Founder of PSAIIF, said, “The petition had been filed seeking issuance of directions to the Respondents to identify and furnish a list of all second-hand and re-furbished High-End And High-Value (HEHV) Used Medical Equipment other than Critical Care Medical Equipment that have been imported into India since 2019 without permission of the Ministry of Environment Forest and Climate Change (MoEFCC) and for directions to Companies including the Intuitive Surgical to immediately recall all such Refurbished HEHV Medical Equipment that are installed without prior approval as per the Rules and Regulations and stop the import of Refurbished HEHV Medical Equipment including the systems that are at customs cleared and not installed at customer locations until the Government inter-ministerial committee of Respondents decides on implementation of policy framework that would regulate the import of such devices.” The petition points to one company, Intuitive India Private Limited, a subsidiary of Intuitive Surgical Inc., which allegedly imported refurbished equipment worth over INR 250 crores since 2019, presumably without the required MoEFCC approval. The petition notes that prior to 2023, the import of refurbished medical devices, particularly HEHV devices, was not permitted. Even after the DGHS notification in June 2023 allowed select devices under strict conditions, MoEFCC’s approval remained mandatory. The Delhi High Court directed PSAIIF to submit representations to the concerned respondents and granted permission to approach the court again if the responses were deemed unsatisfactory. Recently, PSAIIF received responses from both MoEFCC and DGHS. According to MoEFCC’s 133rd meeting in May 2024, Intuitive India had approval to import one refurbished Da Vinci X robot in 2019. However, the company allegedly continued importing equipment worth over INR 250 crores without the required approvals in subsequent years. Professor Misra stated, “Since the responses have been received pursuant to court order, no statements can be made on the same until conclusive legal advice is taken on the same.” Despite these concerns, MoEFCC granted further approvals in 2024, which is in conflict with DGHS’s position that imported devices should not be allowed if similar devices are manufactured in India under the “Make in India” initiative. Professor Misra noted that this inconsistency undermines domestic manufacturers’ confidence and threatens the success of the government’s policy, describing the situation as an “Un-make in India” campaign. The illegal import of refurbished medical devices without proper certification and oversight not only violates India’s regulatory framework but also jeopardises patient safety. PSAIIF calls for immediate action to enforce compliance and increase public awareness to ensure that only safe, certified medical devices are available in the Indian market. Source: Economic Times

Oct 24, 2024 Chandigarh: Two organ donations, facilitated by four green corridors spanning four locations across the country over the span of two consecutive days, have given the ‘gift of life’ to eight terminally ill organ failure patients, a PGIMER statement said here on Wednesday. It said in both the cases, the families of young individuals who lost their lives in road accidents made the courageous decision to donate their loved ones’ organs. The decision saved eight precious lives with the transplantation of heart at Medanta, Gurugram; lungs at KIMS hospital, Secunderabad; two livers at Institute of Liver and Biliary Sciences, New Delhi; two simultaneous kidney- pancreas and two kidney transplants here at Post Graduate Institute of Medical Education and Research (PGIMER). Lauding the team, PGIMER Director Vivek Lal said, “The successful allocation and transplantation of all vital organs over two days showcased seamless coordination and a monumental effort by all stakeholders. This collective endeavour is a testament to PGIMER’s exceptional capabilities and determination to save lives.” On October 22, organs of a 24-year-old victim of a road accident were donated after the family made the selfless choice to offer hope to others. As there were no matching recipients for the heart, lungs and liver at PGIMER, the Regional Organ and Tissue Transplant Organisation, PGIMER swiftly acted to allocate the organs across various hospitals via their apex body National Organ & Tissue Transplant Organisation. “The heart was airlifted to Medanta Hospital in Gurugram, the lungs were sent to KIMS in Secunderabad and the liver was flown to ILBS in New Delhi. Additionally, a simultaneous kidney-pancreas and a kidney were transplanted at PGIMER, saving two more lives locally. This magnanimous decision saved a total of five lives,” the statement said. A day earlier, on October 21, another 18-year-old male, declared brain dead at PGIMER, had his organs donated. In this case, the liver was allocated to ILBS, New Delhi, while a simultaneous kidney-pancreas and a kidney were successfully transplanted at PGIMER, saving two additional lives. One of the donors’ father, said, “In our son’s memolY, we wanted to give others a chance at life. This is what he would have wanted.” The same sentiment was echoed by another donor’s mother as she said, “Our pain will always remain, but knowing that he lives on in others brings us some peace.” Vipin Koushal, Medical Superintendent and Nodal Officer, ROTTO North, PGIMER, praised the coordination efforts, stating, “We are deeply thankful to the families for their noble gestures, and to the Chandigarh Traffic Police for their unwavering support in making these green corridors possible. It is this teamwork that makes organ donation a reality.” “Over the two days, four green corridors were established to ensure timely transportation of organs, showcasing an exceptionally well coordinated effort by each one involved, that is vital for the success of organ transplantation,” Koushal added. Source: Economic Times

Oct 24, 2024 Kolkata,: Despite the complexities of poliovirus that make it difficult to stop from spreading, an expert on Thursday said that the disease is “gasping” and is on the verge of eradication from the global map. Heaping praise on India for playing an exemplary’ role in effectively dealing with polio, researcher Dr Ananda Sankar Bandyopadhyay sounded caution that any complacency could help the disease make a comeback. Bandyopadhyay, who is the Deputy Director of Technology, Research, and Analytics, Polio Team, with the Bill and Melinda Gates Foundation, was speaking exclusively to PTI on the occasion of World Polio Day on Thursday. “Polio has three serotypes type 1, type 2 and type 3. Type 2 and 3 were eradicated from the world. Poliovirus type 1 remains mainly in two countries – Pakistan and Afghanistan. So, about the global situation, we can say that polio is on the verge of eradication,” he said. Besides Pakistan and Afghanistan, there are about 15 countries primarily in the African region where an outbreak of a variant poliovirus type was seen recently, he said. “So, it’s really good news that polio does not exist in most of the countries,” Bandyopadhyay said. The researcher also praised India saying the country has done a commendable job in eradicating polio. “The fact that India can maintain its polio-free status is really an amazing feat and we should be proud of that and celebrate that. It has huge implications in terms of other public health delivery programmes,” Bandyopadhyay said. Asked whether it is possible to permanently eradicate polio from the world, the expert said, “From a scientific perspective, polio as a virus is gasping. In Pakistan and Afghanistan exists the wild type poliovirus whereas in a few countries in the African region, the variant poliovirus type exists. “Based on this, you can say that eradication is feasible because most countries have decisively stopped polio but of course, challenges remain.” Explaining the problems in eradicating the disease completely, he said that in certain countries it is difficult to vaccinate all the children all the time. “These are areas affected by wars, civil unrest, and insurgencies in parts of these countries. So the children are unfortunately vulnerable and are not receiving the vaccination that they deserve,” said the expert who had earlier worked with the World Health Organisation (WHO). If all children of all communities can be inoculated in these countries, the spread of polio could be stopped decisively, he said. About the reasons behind the resurgence of polio in Gaza almost after a quarter of a century, the expert said, “There is one single reason: children in places like Gaza unfortunately have no access to vaccination. On top of that, they do not have access to clean drinking water. Sanitation system and hygienic practices were also disrupted due to the war.” Besides polio, other life-threatening diseases could also emerge because of the situation there, Bandyopadhyay said. On whether polio could reappear at a place where it was once eradicated, he said that resurgence is possible in case of a dip in the vaccination coverage and relaxation of surveillance on the disease. Asked if polio, like coronavirus, has any chance of emerging in a different form, of which the world is unaware at the moment, the WHO researcher said that the genetic structure of the poliovirus tends to revert to evolve in newer strains. “Yes… there is a risk that newer subfamilies of the poliovirus could evolve and we have seen that in different areas, although the overall serotype of polio remains intact,” he said on World Polio Day. World Polio Day is observed on October 24 every year to emphasise efforts taken around the world to eradicate Polio alongside raising awareness of the importance of vaccination to protect every child from this life-threatening disease. Source: Economic Times

Oct 17, 2024 New Delhi: Indian Council of Medical Research (ICMR) Director General Dr Rajiv Bahl spoke about new projects and achievements in public health and highlighted a significant advancement in tuberculosis (T B) diagnosis: a new handheld X-ray device developed for screening T B, enhancing early detection and treatment efforts, ultimately improving public health outcomes. Speaking at the 19th International Conference of Drug Regulatory Authorities (ICDRA) INDIA-2024 on Wednesday, ICMR DG Dr Bahi said, “The handheld X-rays are available at a very high cost and now the IIT Kanpur in partnership with ICMR has developed a handheld X-ray indigenously which will be less than half the cost of what the cost of imported handheld X-rays are. This will make sure we can have screening for TB near the homes of patients and even the vulnerable population.” Bahl further said that India has developed three testing kits for Mpox as well. “We have developed three testing kits for Mpox and there are three companies who are manufacturing such kits,” he said. Over a million people are affected in India with sickle cell disease, which is the second largest in the World, last year Prime Minister Narendra Modi also launched the National Sickle Cell Anaemia Elimination Mission to eliminate sickle cell disease as a public health problem by 2047. ICMR is constantly working on this and recently they have conducted a brainstorming session with doctors and scientists all over the country at the New Delhi Head office. According to Dr Rajiv Bahl, India has developed 18 tests with low cost to detect Sickle Cell Anaemia which is a major breakthrough, “Now we have approved 18 tests for Sickle cell Anemia and each test costs rupees 30 which was earlier 400 per test.” India lost several lives due to Dengue but now vaccine for dengue is also expected to be launched soon if data shows efficacy and safety, Dr Bahl said, “We are doing phase three clinical trial of dengue vaccine and we expect the results to come within one year or so and found safety as well as efficacy then India will develop dengue vaccine also.” (ANI) Source: Economic Times

Oct 24, 2024 London: Britain will ban single-use vapes from next year, a government minister said on Thursday, seeking to crack down on the environmental harm and rising usage levels among children. Health authorities have raised concerns about the use of vapes among young adults, with their colourful designs and fruity flavours making them stand out on grocery store shelves. According to a 2024 survey by health charity ASH, about one in five children aged 11-17 said they had tried vaping. It is illegal to sell nicotine-containing e-cigarettes to anyone under the age of 18 or for adults to buy them on behalf of under-18s. The plan to ban disposable vapes was initially set out by the previous Conservative government in January but was not implemented before the July election, which was won by the Labour Party. Labour’s culture minister said that the number of children vaping had tripled in the last three years, and that disposable vapes were causing a lot of problems for the environment. “We have been increasingly concerned,” she told Sky News. “We hope (this) will help to break this cycle where children are getting into the habit of vaping at younger and younger ages.” The government’s Department For Environment, Food, and Rural Affairs (Defra) did not immediately respond to a Reuters’ request for details on the measure. Media reports said the ban was due to come into force in June. A separate study by ASH this year said vapes were the most popular aid to quitting among tobacco smokers, with nearly 3 million people in Britain having quit smoking with a vape in the last 5 years. Source: Economic Times

Oct 23, 2024 New York: Most U.S. states do not currently cover highly sought after weight- loss drugs from Novo Nordisk and Eli Lilly in their Medicaid health programs for low income people, citing cost as a key factor, according to a survey conducted by health research firm KEF. The survey of the 50 states and the District of Columbia found that just 12 Medicaid programs covered the drugs to treat obesity as of July 2024 with some limits on use. Half of the states without coverage said they are considering adding them or evaluating their coverage, it said. The drugs from a class known as GLP-I agonists were initially developed to treat type 2 diabetes but also promote weight loss by suppressing hunger. Novo’s Wegovy and Lilly’s Zepbound list for around $1,000 per month, though most people pay less through health insurance or other drug company discounts. Coverage of the drugs by commercial plans is also limited. The Medicare program for people aged 65 and older has said that GLP-I drugs may be covered for diabetes and cardiovascular disease after studies revealed healt benefits. The survey found that state Medicaid programs expect their health plan spending to increase by 7% in fiscal 2025, slowing from the 19% increase this year as membership decreases. The fiscal year ends for most states in the survey on June 30. The lower spending increase from a year ago follows termination of a policy requiring insurers to keep members enrolled during the COVID-19 pandemic and the expiration of some federal funding. Medicaid costs are paid by states and by the U.S. federal government. Total spending on Medicaid rose 5.5% in fiscal 2024 and is expected to increase 3.9% in fiscal 2025. Medicaid membership re-determinations have decreased enrollment from a peak of 94 million in April of 2023. There were some 71 million on its rolls ahead of the pandemic. As of August, four states were still re- determining Medicaid eligibility. State Medicaid programs expect memberships to decline by around 4.4% in 2025 from a 7.5% decrease in 2024, KFF said. Increased costs of providers, managed care, medical benefits and prescription drugs were key drivers of spending, according to the survey findings. Three quarters ofthe states are exploring at least one new or expanded initiative to contain prescription drug costs in 2024 or 2025, KFF found. (Reporting by Amina Niasse; editing by Caroline Humer and Bill Berkrot) Source: Economic Times

Oct 21, 2024 Wellington: Anyone who has spent time inside a neonatal intensive care unit (NICU) knows it’s intense. For the tiny babies cared for in these wards, any infection could prove fatal. Great care is taken to prevent the spread of pathogens, but outbreaks still occur. Traditionally, detecting outbreaks within a NICU has been reactive – only after multiple babies fall ill at the same time. Our research is advancing the use of whole-genome sequencing technologies to detect outbreaks early and stamp out bacteria before they threaten more babies. From reactive to proactive NICU outbreak surveillance usually involves monitoring rates of illness and identifying spikes and long-term trends that may point to a pathogen circulating on the ward. When a potential outbreak is identified, bacteria may be cultured and retrospectively sequenced to determine if they can be linked to a shared source or transmission on the ward. Wellington Regional Hospital has changed its approach to infection surveillance in the NICU. Rather than waiting for infants to fall ill, they are using the same sequencing technology we developed at the Institute of Environmental Science and Research (ESR) for genomic contact tracking during the COVID pandemic. Infants in the unit have diagnostic swab samples taken as part of routine practice. If any key bacteria are cultured from these samples, they are sequenced promptly to identify possible transmission events in near real time. This allows us to monitor the situation closely and respond quickly to emerging outbreaks. Because not all infants carrying a particular bacterial strain will experience a severe infection, this proactive approach can detect an outbreak before any babies fall ill. And because whole-genome sequencing decodes the entire genetic makeup of bacteria, it also provides the NICU team with information on how pathogens are related to each other. This allows them to differentiate one-off cases imported to the unit from any circulating within it. This level of detail allows for precise infection monitoring and fast, informed decisions on outbreak control. A case study This shift was recently tested when proactive genomic surveillance showed two infants in the NICU had eye infections caused by the same organism, an uncommon strain of methicillin-resistant Staphylococcus aureus (MRSA). MRSA is notorious for its resistance to common antibiotics, making it particularly dangerous in hospitals. The onsite sequencing showed the two cases were likely linked. The priorities were to establish whether other infants were affected and limit the pathogen’s spread as quickly as possible. Screening of infants in the NICU found six more carrying the same strain of MRSA (though none with serious illness). This meant these infants could be isolated rapidly and the outbreak contained before any others developed a significant infection. ESR’s experience as genomic contact tracers helped establish how these infections spread in the unit. An outbreak response takes up resources and involves multiple steps, from the initial confirmation of the infection and its transmission route to communication with parents. This proactive approach to infection surveillance provides an early- warning system. It means the NICU team can be confident an outbreak is underway and act quickly to contain it. MRSA in New Zealand The power of genome sequencing extends beyond immediate outbreak control. By comparing the genomic data generated in the lab to that collected in national surveillance projects, our team was able to show the strain that caused the eye infections may have emerged in the early 1990s. This strain has slowly accumulated the genes required to evade first- choice antibiotics, underpinning the risk of antibiotic-resistant bacteria in Aotearoa New Zealand. We also highlighted the power of genomics to reveal connections when we found the MRSA strain causing illness in the NICU was related to bacteria collected from cattle. This discovery underscores the concept of “One Health” – the idea that human health, animal health and environmental health are inextricably linked. The data suggest bacteria from a cow milk tank and from babies in a hospital may have shared a common ancestor at some point. Future focus As we continue to unravel the complex world of microbes, tools like whole-genome sequencing offer hope in the ongoing battle against infectious diseases. The work at Wellington Regional Hospital’s NICU is just the beginning. From protecting our most vulnerable newborns to uncovering unlikely connections between farm animals and hospital patients, genomic technology is changing how we combat infectious diseases. As this technology continues to evolve, it promises to play an increasingly crucial role in safeguarding public health, one DNA sequence at a time. In the face of growing antibiotic resistance and emerging pathogens, this proactive, genomics-based approach to infection control may well be our best defence. (The Conversation) PY PY Source: Economic Times

Oct 24, 2024 In 1893, the American Journal of the Medical Sciences reported on ten patients whose large and hitherto incurable cancers had been injected with bacteria taken from skin infections. In every case, striking improvement was seen, marking the birth of “cancer immunotherapy” – using the power of the immune system to attack cancer. The immune system is the body’s most powerful weapon against cancer and infection. For a cancer cell, surviving long enough to divide and eventually form a lump or tumour is the result of a brutal Darwinian process. To reach this point, cancer must adapt, hiding from immune detection and co-opting patients’ immune machinery to betray its original programming and instead protect the cancer. Immunotherapy – which really started to take off just over a decade ago – is an attempt to artificially tip the balance back in favour of tumour elimination. Sometimes this can be done by taking off the brakes from immune cells already in the cancer. This works because cancers have fooled the body by using its own natural safety switches, or “checkpoints”, that usually keep our immune systems under control. Blocking these switches using specially chosen antibodies – biological drugs – turns the immune response back on. This approach is called “immune checkpoint blockade”. Mutations are alterations in genetic code that can lead to cancer. All cancers fall on a spectrum, depending on how many mutations the cells have. Typically, cancers caused by exposure to toxic or harmful things have higher numbers of mutations than those which are not – examples include melanoma, a type of skin cancer, and some types of colon cancer. From the perspective of the immune system, the more mutations there are, the “hotter” the cancer is. This may make a cancer more aggressive, but it also increases the chances that the immune system will have detected it and mounted a response. This is why immune checkpoint blockade therapy works well for these high-mutation cancers, but less well for others. The other type of immunotherapy does not rely on the natural activity of the immune system. This approach uses immune machinery that is designed in a laborat01Y, a bit like biological Lego. Scientists take pieces of existing immune mechanisms and combine them to make new ones, which enhance the way the body’s defence system responds. When put into the patient’s T-cells (a type of immune cell that usually fights viruses), this machinery allows them to attack and kill cancer. Called cell therapy, this approach has cured patients with previously incurable leukaemia. The new machinery, called a “chimeric antigen receptor” or “Car”, transforms a diverse Wcell population into Car-T, where the engineered cells all respond to the same cancer-associated marker. Victims of their own success Both types of immunotherapy have been victims of their own success. This has led to the replication of existing technology rather than riskier diversification. Of 11 immune checkpoint blockade treatments approved by American regulators, nine target the same immune interaction. And of the Car-T cell treatments approved in the US since their debut in 2017, all target one of two markers found exclusively on blood cancers. Substantial effort has been spent on iterative developments of the existing Car concept. Examples include changing the target or tuning the signals that stimulate the T-cells. This has yielded important advances, but the saturation of both academic and commercial research space has contributed to a diminishing appetite for funding more cell therapy programmes. Success against solid cancers has also been extremely low. The Darwinian adaptiveness shown by cancer creates a suppressive environment in a cancer lump, where it is hard for Car-T to work properly. So, reliance on a single technology has not delivered on its initial promise. Given that Car-T costs around GBP 282,000 per patient in the UK, and the patient’s disease often worsens in the two-to-three weeks it takes to manufacture them, confidence is waning. This phenomenon is not new. In the 1950s, confidence in chemotherapy was low because single drugs failed to produce lasting cures. But by the 1960s, combination chemotherapy began to deliver durable patient benefit, and multi-drug regimens now form a mainstay of cancer therapy. Immunotherapies that use combination approaches are now emerging. Recent research from University College London demonstrated how engineered immune cells called gamma-delta T-cells could act as delivery vehicles for anti-cancer antibodies. In this approach, not only did the engineered cells kill cancer in mice, they also empowered other cells to join the fight. Also, gamma-delta T- cells can be safely taken from a healthy donor and given to several patients. So there is hope. Cell therapies that can be made beforehand from healthy donor cells and then stored, ready to use, are receiving more interest. For example, the number of trials using gamma delta T-cells doubled between 2022 and 2023, the fastest-growing area of activity. This could remove the waiting time for treatment manufacture, reducing the chance of disease worsening in the interim. A move away from reliance on single-axis immune interventions, such as immune checkpoint blockade or Car-T in isolation, should yield better outcomes. The immune system is highly complex. Our attempts to manipulate it must live up to this complexity if we are to deliver lasting patient benefit. (The Conversation) GRS GRS Source: Economic Times