PSM News

June 22,2024 Washington: The Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco smoking. The FDA said it authorized four menthol e-cigarettes from Njoy, the vaping brand recently acquired by tobacco giant Altria, which also sells Marlboro cigarettes. The decision lends new credibility to vaping companies’ longstanding claim that their products can help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease and heart disease. E-cigarettes have been sold in the U.S. since 2007 but in recent years their potential benefits for smokers have been overshadowed by their use by adolescents and teens. Parents and anti-tobacco groups immediately criticized the decision, which follows years of advocacy efforts to keep menthol and other flavors that can appeal to teens off the market. “This decision could mean we’ll never be able to close the Pandora’s box of the youth vaping epidemic,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “FDA has once again failed American families by allowing a predatory industry to source its next generation of lifetime customers – America’s children.” Youth vaping has declined from all-time highs in recent years, with about 10 per cent of high schoolers reporting e-cigarette use last year. Of those who vaped, 90 per cent used flavors, including menthol. All the e-cigarettes previously authorized by the FDA have been tobacco, which isn’t widely used by young people who vape. Njoy is one of only three companies that previously received FDA’s OK for vaping products. Like those products, two of the Njoy menthol varieties come as cartridges that plug into a reusable device that heats liquid nicotine, turning it into an inhalable aerosol. The other two Njoy menthol products are disposable e-cigarettes. Njoy’s products accounted for less than 3 per cent of U.S. e-cigarette sales in the past year, according to retail data from Nielsen. Vuse, owned by Reynolds American, and Juul control about 60 per cent of the market, while hundreds of disposable brands account for the rest. Source: Healthworld

June 18,2024 New Delhi: Three days before the National Eligibility-cum-Entrance Test (NEET-UG) on May 5, some students received pop-up alerts on Telegram: “Leak paper available, price Rs 5000, message to buy @HQPaper.” The Supreme Court has now issued notices to the Centre and NTA on these alleged leaks after PILs piled up. But RTI activist Vivek Pandey says he had posted about these ‘leak paper’ offers on social media platforms even before the test. “But it fell on deaf ears,” he says. On May 5, the day of the exam, Pandey felt a sense of deja vu. But rather than just being happy with his I-told-you-so moment, Pandey has been spending most of his time filing complaints with the Union health ministry on the problems with NEET-UG, seeking updates from Bihar police about investigations into a leak from the state while also petitioning for action against the NTA in the SC. He had earlier filed an RTI seeking clarifications on the grace marks awarded by NTA which later withdrew them. Discrepancies in exams are personal for him. He attempted to pass the pre-medical test (PMT) in Madhya Pradesh for nearly four years but always ended up in failure. It was only when the Vyapam scam-where students cheated on a large scale to pass the state medical exam in connivance with senior officials, teachers and many middlemen- hit headlines that he realised that he was trying to win a fixed match. Pandey eventually cracked NEET but decided to work towards greater transparency in the medical education system, , filing around 1,000 RTIs since 2016. Though no one paid heed to his warnings in May, they are paying attention now. “When the ‘leak’ stories came out, we had a small group of 50 students who were disturbed by the reports. Now our support group has expanded to 4,500,” Pandey says, adding that there are lakhs who are now up in arms against the NTA. Like Pandey, Kota-based educator and students rights’ advocate Dr Amit Gupta regularly posts videos sharing the plight of aspirants, amassing nearly 30,000 followers on X (formerly Twitter). Gupta, who completed his MBBS but decided to become a teacher instead, began his ‘activism’ in 2015 after the AIPMT paper leak. “I gathered about 2,000 students, and we decided that enough was enough. Every time the cheaters just get away,” Gupta says. The group held rallies and dharnas, demanding a re-exam. However, they soon realised that taking the judicial route would bear more fruit. Eventually, the SC ruled in their favour. Since then, 46-year-old Gupta has been fighting for other reforms too. This year, after the NEET results row, Gupta began helping students out to file petitions. Years of experience in fighting legal battles have come in handy as his lawyers help students draft petitions and crowdsource legal fees. “If students take a single exam on one date with a single question paper in offline mode, there are bound to be leaks. Why can’t we adopt the JEE model where multiple question papers are prepared and exams are held on different dates online?” he asks. Union education minister Dharmendra Pradhan has denied that there have been any leaks calling the allegations motivated. But the turmoil among students and parents has been hard to contain. Source: Healthworld

June 18,2024 New Delhi: Post-resolution of the National Eligibility-cum-Entrance Test-undergraduate (NEET-UG) controversies, significant reforms are anticipated within the National Testing Agency (NTA). According to govt sources, extensive changes in the agency’s operations and exam administration are under consideration, with a high-level committee likely to be established for recommendations.. The NEET-UG 2024 results, announced on June 4, faced widespread criticism from students and parents. Legal challenges were filed against the results, highlighting three main issues: the provision of grace marks to some students, claims of a leaked question paper, and suspected irregularities at specific exam centres. Many have called for an investigation and a retake of the exam. Union education minister Dharmendra Pradhan emphasised on Sunday that the “harshest punishment” would be administered to those found guilty in the NEET UG 2024 “scam”, while assuring students and parents that govt is taking the matter seriously. A senior govt official said: “The matter is currently in the courts. The education ministry and NTA are also examining the details. However, once the issue is resolved based on the investigations and court orders, significant reforms will be initiated in all aspects of conducting these crucial examinations.” The official added that the ministry of education is likely to form a committee to recommend the reforms. As of Nov 2023, the NTA registered over 1.23 crore candidates, making it one of the largest exam-conducting bodies globally, second only to China’s Gaokao, which registered 1.29 crore candidates in 2023. For NEET-UG 2024, over 24 lakh candidates registered, while 14.7 lakh registered for the Joint Entrance Examination (Main), and more than 13.4 lakh for the CUET-UG 2024. Besides these major entrance exams for various undergraduate programmes, NTA also conducts other exams such as the National Council of Hotel Management Joint Entrance Exam (12,738 candidates), the Admission Test for Diploma in Sports Coaching (ATDSC) – 2024 of the National Institute of Sports (NIS), the Graduate Aptitude Test – Biotechnology (GAT-B), the Common Management Admission Test, the Graduate Pharmacy Aptitude Test, the All India Sainik School Entrance Exam, and Swayam examinations, among others. Speaking to TOI, Pradhan said, “Govt will thoroughly review what happened in NEET and take steps to reform both the examinations and NTA. NTA is evolving and not perfect; we need to strengthen it further. We are concerned about the future of lakhs of young students.” In addition to three of the most competitive and high-profile entrance exams-NEET-UG and PG, CUET-UG and PG, and JEE (Main)-NTA also conducts the NET for UGC, recruitment exams for the Employees’ Provident Fund Organisation, Navodaya Vidyalaya Sangathan, Central Universities and Military Nursing Service, among others. Govt sources indicate that the planned reforms will include administrative, operational and logistical changes (centres and question papers) and capacity building, among other areas. Source: Healthworld

June 17,2024 New Delhi: The Centre on Sunday said that some discrepancies in the conduct of 2024 National Eligibility-cum-Entrance Test (Undergraduate) from specific locations have come to light and whoever found guilty, “even if it is NTA”, will not be spared. The Opposition has, in the meanwhile, declared that it will seek a scrutiny and review of NEET exams and NTA’s functioning by a parliamentary standing committee. The developments played out in the backdrop of the economic offences wing of Bihar Police arresting a few people and issuing summons in its probe into the alleged NEET paper leak. Union education minister Dharmendra Pradhan told media persons at Sambalpur, Odisha, that “in the NEET examination, some discrepancies from some specific locations have come to light. The government is trying to rectify it. Wherever we are getting verified information, action is being taken by keeping the court informed as the Supreme Court is monitoring the issue. The government is committed to make examinations like NEET 100 per cent transparent. I want to assure the students that whoever is found guilty, even if it is NTA, will not be spared”. He further said: “Strict action will be taken. The entire matter is in the court and the Supreme Court is monitoring it. We will not let anything go wrong.” Congress leader Jairam Ramesh, who is also party’s chief whip in the Rajya Sabha, said: “Serious questions have been raised about the integrity of the National Testing Agency and the way NEET is designed and administered. NCERT itself has lost its professionalism over the past decade. It is expected that the new standing committee, when formed, will conduct a thorough review of NEET, NTA and NCERT. This should be given top priority.” He added: “I was a member of the Parliamentary Standing Committee on Health and Family Welfare between 2014 and 2019. I remember the widespread support for NEET at that time. But there were also MPs – especially from Tamil Nadu – who expressed concern that NEET would benefit CBSE students and harm students from other boards. I feel CBSE needs to do a proper analysis on this issue. Is NEET discriminatory? Are students from poor backgrounds being denied opportunities? Other states like Maharashtra have also expressed deep doubts about NEET.” Source: Healthworld

June 16,2024 New Delhi: Citing significant inconsistencies and lack of accountability in the referral process, the Union Health Ministry has for the first time issued interdepartmental referral guidelines for hospitals to facilitate better communication and cooperation. The ‘Guidelines for Inter-Departmental Referral (within hospitals)’ stress that referrals should be initiated promptly as and when patients require specialised care, diagnostic evaluations or consultations beyond scope of admitting department. The referral for a consultant’s opinion should only be written by consultants and that post graduate residents should not close referrals on their own without discussing with their consultants, the guidelines released on June 7 stated. Consultant on call should review the referral record attended to by his team the previous day, a step which will help improve patient care and enhance learning of residents. The referral process is a crucial component of high-quality patient care in any medical institution, Director General of Health Services, Union Health Ministry, Dr Atul Goel said in the document. Problems such as poor coordination and communication, unclear procedures, non-standardised formats, and inadequate training for healthcare professionals are common and they ultimately can potentially harm a patient, Dr Goel said. The roles of various professional levels are often undefined, resulting in gaps in patient care, he stated highlighting many patients who visit hospitals have multiple co-morbidities and need a multi-disciplinary approach. The document said a robust and efficient referral mechanism should be an essential part of training of residents as well. After residency as they enter a healthcare setup to practice, this training will be very useful for them. However, problems can arise in any inter-departmental referral process, including –delays in processing/attending of referrals, breakdown in communication, and variations in referral practices across departments, it said. To address these challenges, hospitals must implement standardised referral protocols, streamline referral work flows, and provide education and training to healthcare providers and staff involved in the referral process. “Currently, with no clear guidelines in place, it has been observed that there exist heterogeneous referral mechanisms. Every department and individual have their own way of sending and attending referrals. The documentation is also variable and inconsistent. “There are delays in attending to referrals which can affect patient care adversely. Mostly junior residents (first or second-year post-graduates) see referrals where higher order inputs may actually be required. There are conflicts between departments regarding referrals which are mostly rooted in lack of communication,” the document stated. The guidelines stated that departments can prepare a roster with names of officers in various units with contact numbers and availability of units on different days, time; place where referral needs to be sent. This should be available on website as well as circulated within the institution. The referral should help patient management without burdening the referring department with a huge list of investigations. Any investigation by the referral team should be completely justified from the diagnosis offered, the guidelines said. Among the Do’s, the guidelines said referrals should be documented accurately and comprehensively, including relevant clinical information, expected outcome from referral, patient preferences, and any other specific instructions. “Communicate clearly and effectively with receiving departments, providing necessary clinical information and patient context to facilitate appropriate evaluation and management,” it said. The guidelines emphasised following up on referrals and coordinating care transitions, ensuring that patients receive necessary follow-up appointments, treatments, and interventions. It also calls for seeking feedback from referring providers and receiving departments to identify areas for improvement and enhance the efficiency and effectiveness of the referral process and prioritising patient-centred care, considering patients’ preferences, values, and treatment goals in referral process and treatment planning. Source: Healthworld

June 16,2024 New Delhi: Bharat Biotech’s indigenous rotavirus vaccine Rotovac used in the government’s immunisation programme increases the risk of intussusception in infants, a new study found. Intussusception is a condition where the intestine telescopes into itself and can lead to gangrene of the bowel or death if not treated immediately. The study has been published in the International Journal of Risk and Safety in Medicine. Bharat Biotech has dismissed the findings claiming the vaccine has been evaluated for safety. The study, co-authored by Jacob Puliyel, MD of the International Institute of Health Management Research, India, and Brian Hooker, chief scientific officer, Children’s Health Defense, found that there was a 1.6-fold increase in the risk of intussusception in the vaccinated, which was missed in the earlier analysis. “Additionally, the mean age of developing intussusception was lower in the vaccinated babies, putting them at risk of serious harm, including death,” it said. Puliyel told ET that those who are getting the vaccine must be told that there is a risk as they may easily mistake it for dysentery and take it lightly. “There is a terrible risk as this is a surgical emergency and must be treated. So, the parents need to be informed,” he said. In 2020, a New England Journal of Medicine analysis found there was no risk of intussusception from Rotavac, a live attenuated rotavirus vaccine. A statistical method called self-controlled case series (SCCS) determined that the risk of intussusception in the high-risk window (21 days after any dose of the vaccine) was comparable to the background risk. The company said that the data is not new, but it is reanalysis of old data that was “out of line with the experimental design and statistical plan. Hence, it cannot be interpreted in a meaningful manner to merit serious consideration,” it further said. “Rotovac is manufactured using human rotavirus strains and not from animal origin. Hence, the rate of intussusception is similar in vaccinated and non-vaccinated subjects,” the company said in a statement. Source: Pharma

June 08,2024 New Delhi: Prominent spice brands failed quality tests conducted by the Rajasthan health department as part of the state’s campaign against food adulteration, with samples from reputed Indian companies – such as MDH, Everest, Gajanand, Shyam, and Sheeba Taza – found unfit for consumption. State health minister Gajendra Singh Khinvsar has directed stringent action against these companies under Indian Food Safety and Standards Act, including the immediate confiscation of the unsafe spices. MDH’s garam masala contained acetamiprid, thiamethoxam, and imidacloprid while its vegetable masala and chana masala had tricyclazole and profenofos. Shyam’s garam masala contained acetamiprid, Sheeba Taza’s raita masala had thiamethoxam and acetamiprid, Gajanand’s pickle masala had ethion, and Everest’s cumin masala contained azoxystrobin and thiamethoxam. The health department investigation revealed that pesticide/insecticide levels in these spices were significantly higher than permissible limits, posing serious health risks. A targeted operation was launched on May 8 to gather spice samples from all districts in the state. During this drive, 93 samples from various companies were collected. A report by the State Central Public Health Laboratory indicated that certain samples contained alarmingly high levels of pesticides and insecticides, Shubhra Singh, additional chief secretary (health) said, adding that letters had been sent to all designated officers and chief medical and health officers throughout the state, instructing them to seize the unsafe spices. Since MDH’s manufacturing units are in Haryana, that of Everest and Gajanand in Gujarat, letters have been sent to food safety commissioners of these states for necessary action. Additionally, a letter was sent to the chief executive officer of the Food Safety and Standards Authority of India in New Delhi, requesting their intervention. Food safety commissioner Iqbal Khan said samples of other spices from these companies – as well as additional batches of the unsafe batches – will also be collected. He has directed the chief medical and health officers to seize affected lots or batches of these spices from these brands, manufacturers, distributors, and wholesalers. Directives have also been issued to collect samples of other spices and spice powders from these brands. Source: Healthworld

June 22,2024 London: The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s combination therapy for treating colorectal cancer in patients with a specific gene mutation, the health regulator said on Friday. The approval under the agency’s accelerated process was based on an early- to mid-stage study, in which 94 previously treated patients were administered the oral drug Krazati, in combination with cetuximab. About 34 per cent of the patients who were given the combination treatment showed a partial or complete response to it during the study. The combination also helped increase the time patients lived without the disease worsening by 6.9 months. Colorectal cancer is the third most common cancer worldwide, accounting for about 10% of all cancer cases. It is the second leading cause of cancer-related deaths worldwide, according to the World Health Organization. Bristol Myers added Krazati to its portfolio after it completed its up to $5.8 billion acquisition of Mirati Therapeutics in January. Krazati works by targeting a mutated form of the gene known as KRAS that occurs in 3 per cent to 5 per cent of colorectal cancers. It targets specific gene mutations that drive cancer cell count up regardless of the organ in which the disease originated. “The approval helps justify Bristol’s decision to buy Mirati,” Morningstar analyst Damien Conover said. He estimates just over a billion dollars in annual sales for Krazati. Bristol recorded $21 million in U.S. sales of Krazati for the quarter ended March 31, 2024. The FDA’s decision adds on to Bristol’s goal to diversify its oncology business as the company faces pressure from declining demand for two of its top drugs – the blood cancer treatment Revlimid and blood thinner Eliquis, which face generic competition. Krazati had received accelerated approval from the FDA in 2022 for the treatment of a type of advanced lung cancer with the mutated form of the gene known as KRAS. Source: Pharma

June 20,2024 New Delhi: Last year, Google-owned YouTube announced partnership and product updates to support wellbeing and mental health of teens on the platform. It is now rolling out those features, which include limiting the recommendation of videos that could be negative if watched repeatedly, in more countries. James Beser, director, product management, recently spoke about how teens can navigate their growing individual interests. He emphasised that YouTube’s updates will help teens put their safety, privacy and wellbeing on priority. Additional safeguards for teen content recommendations Beser explained how YouTube is limiting repeated content recommendations for teens of videos featuring social comparison and aggression. The company worked with an Advisory Committee to identify “categories of content that may be innocuous as a single video, but could be problematic for some teens if viewed in repetition.” “These categories include content that compares physical features and idealises some types over others, idealises specific fitness levels or body weights, or displays social aggression in the form of non-contact fights and intimidation,” the company said in a blog post when it announced the features in November To help teens manage their screen time, YouTube notifies them with “Take a Break reminders”. These reminders will help teens set boundaries to manage time spent online and disconnect when needed. The feature is available since 2018, and is on by default for teens users (for every 60 minutes) but will now be visually prominent in viewers’ feeds across long-form and Shorts. Beser also said that these reminders will now appear more frequently. YouTube is also expanding crisis resource panels into a new full-page experience. When teens search for sensitive topics such as related to suicide, self-harm, and eating disorders on YouTube, a new full-page experience will help viewers pause for a moment and explore health topics. “Viewers will more prominently see resources for third-party crisis hotlines as well as suggested prompts to steer search queries towards topics like ‘self-compassion’ or ‘grounding exercises’, the company said. This feature has also rolled out for viewers of all ages where crisis resource panels are available. Source: Healthworld

June 18,2024 Washington: Erin Fox has tracked drug shortages for more than 20 years, and she sees no easy solutions for what has become a record run. Total active shortages hit an all-time high of 323 in this year’s first quarter, according to the University of Utah Drug Information Service. That’s up about 86 per cent from a 10-year low of 174 last reached in 2017. There were 48 new shortages recorded this year through March, according to the data, published by the American Society of Health-System Pharmacists. Still, Fox also sees positive news developing. The associate chief pharmacy officer at University of Utah Health spoke recently with The Associated Press. The conversation has been edited for clarity and length. Q: Are there any signs that this is letting up? A: Unfortunately, no. We haven’t necessarily solved some of the root causes. We have, overall, relatively few manufacturers. (The U.S. Food and Drug Administration) halted inspections during COVID. Now they’re back, at factories that maybe haven’t been inspected for five or six years. They’re finding some things to fix. Those fixes can take anywhere from 6 to 18 months for production to get fully back on schedule. Meanwhile, other companies don’t necessarily have the capacity to ramp up production to make up the difference. It’s not the FDA’s fault. We want them to find those quality deficits. But when FDA goes out looking all at once, it can be pretty disruptive. Q: What are the typical drugs that land on the shortage list? A: Generic, injectable hospital drugs or older drugs. They are usually pretty low cost. There’s not a lot of resilience in the supply chain for another company to make up the difference. We saw all those chemotherapy shortages last year in part because a large factory in India, (the FDA) found quality problems there. They made a large amount of the U.S. supply. The other companies were unable to quickly make up the difference. Things have definitely improved, but that factory is still not running. Q: What is one thing about shortages that patients underestimate? A: They shouldn’t automatically assume they won’t be able to get that treatment. It might be delayed or they might have to take a capsule instead of a pill. They might have to call their insurance company to ask if they will cover the brand because sometimes (that) is available while the generic is not. Don’t panic. It’s frustrating to have to do a little bit of work, but usually you will still be able to get a treatment. Source: Pharma