Roche Vabysmo prefilled syringe bags USFDA nod for three causes of vision loss

Basel: Roche has announced the United States Food and Drug Administration (US FDA) has approved the Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to 80 million people globally. The Vabysmo PFS will become available to United States (US) retina specialists and their patients in the coming months.

“We are pleased that the US FDA has approved the Vabysmo PFS for people living with neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion, which are some of the leading causes of vision loss,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.”

Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials in an alternative, ready-to-use format. Vabysmo will continue to be available in a 6.0 mg vial.5

Vabysmo is a bispecific antibody approved for the eye and has demonstrated rapid and robust vision improvements and retinal drying in nAMD, DME and RVO. Retinal drying is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.

To date, Vabysmo is approved in more than 95 countries for nAMD and DME, and in several countries, including the US and Japan, for RVO. Review by other health authorities across the globe is ongoing. More than four million doses of Vabysmo have been distributed globally since its initial US approval in 2022.

Read also: CDSCO Panel Approves Roche’s Protocol Amendment Proposal To Study Inavolisib in combination with Phesgo

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Postponed! NEET 2024 Counselling Likely to Begin at month end, Schedule not Finalised Yet: Report

New Delhi: Even though the National Eligibility-Entrance Test Undergraduate (NEET UG) 2024 counselling was scheduled to commence today i.e. 6th July 2024, the counselling process has now been deferred until further notice. 

This comes after the Supreme Court had earlier denied postponing the counselling schedule of the NEET UG 2024 while considering the pleas alleging paper leak and demanding a re-conduction of the examination. The counselling session was expected to start on July 6 even though the Medical Counselling Committee had not shared any detailed notification and schedule for it.

As per sources, the counselling for admission to undergraduate medical courses has been postponed as the process of issuing letters of permission to some medical colleges is still underway and new seats are likely to be added to the seat matrix.

In this regard, an official source informed PTI, “The date of counselling will be announced once the exercise gets over to ensure seats of the new colleges can be taken up in the first round itself.” They said the counselling may begin later this month.

Also Read: NEET 2024 Controversy: Can’t Hold Re-test for Solitary Candidate, says SC on aspirant’s plea

Meanwhile, an official source informed Education Times that the counselling schedule for NEET UG 2024 examination has not been finalised yet and therefore, it might not start on July 6, 2024.

The Supreme Court will hear multiple NEET-related pleas on Monday i.e. on July 8, 2024. 

The National Testing Agency (NTA), which conducts the National Eligibility-Entrance Test-Undergraduate (NEET-UG) for admissions to MBBS, BDS, AYUSH and other related courses, and the Union education ministry have been at the centre of media debates and protests by students and political parties over alleged large-scale malpractices ranging from question paper leaks to impersonation in the test held on May 5.

This came to light after around 13 people, including four examinees and their family members, were arrested in Bihar for their alleged involvement in the paper leak of the NEET-UG exam. Patna police sources had previously claimed that the NEET-UG question papers along with their answers were provided to around 20 aspirants a day before the date of the exam i.e. May 5, 2024.

Then, the Economic Offences Unit (EOU) of Bihar Police, which took over the investigation, revealed that the brokers involved in the NEET paper leak scam took between Rs 30 lakh to Rs 50 lakh from each of the medical aspirants in exchange for giving them the question paper of the NEET UG 2024 question paper ahead of the examination.

Medical Dialogues had earlier reported that multiple pleas were filed in this connection before the Supreme Court and High Courts. Some of the pleas demanded the scrapping of the NEET UG 2024 exam and holding a retest.

Meanwhile, during the case proceedings, NTA earlier decided to withdraw the grace marks awarded to 1563 candidates and hold an optional retest for those candidates. Those who did not opt for the retest were allowed to retain their original marks, without the grace marks.

The matter is now being investigated by the Central Bureau of Investigation (CBI). Central Government on June 22, 2024, handed over the charge of investigating in the alleged irregularities in the NEET UG 2024 examination to the Central Bureau of Investigation (CBI).

Earlier, while considering the NEET-related pleas, the Supreme Court had refused to defer the counselling/seat allotment process scheduled to commence on July 6. However, the bench had orally observed that the admissions would be subject to the final outcome of the petitions and if the exams were set aside, the counselling would get invalidated consequentially.

The Top Court had also expressed its concern over the alleged discrepancies in the NEET UG 2024 exam. The Court had noted that even ‘0.001& negligence’ in conducting the NEET-UG 2024 exams would be looked into with all seriousness considering the immense labor put in by the candidates for the prestigious examination.

Also Read: NEET 2024: Plea in SC Seeks Re-evaluation of OMR Sheets instead of Cancelling Exam

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PULSUS Group to establish AI based Pharma Healthcare IT Hub in Telangana

Hyderabad: PULSUS Group, headquartered in Hyderabad, to establish AI Based Pharma Healthcare IT Hub with an investment of Rs 300 crore in Ameenpur, located within Telangana’s Sangareddy district.

Dr. Srinubabu Gedela, CEO and Managing Director of PULSUS Group made this announcement on the sidelines of the 73 IPC Congress, an annual event of Pharmacists.

The project aims to revolutionize both the healthcare and IT landscapes. The establishment of this hub is anticipated to have a significant economic impact by creating approximately 50,000 job opportunities. 

Early estimates suggest the hub to generate 10,000 direct positions within the hub itself and an estimated 40,000 indirect jobs through supporting industries and services.
Dr Srinubabu emphasized the transformative potential of AI, stating, “This AI-powered hub will be aligned with IPC congress theme “Role of Indian Pharma: For Global Wellbeing”. By integrating the most advanced artificial intelligence, we aim to streamline processes, enhance precision in drug development, and improve patient outcomes. This positions Telangana at the forefront of healthcare innovation in India.”
As per per UNI report, the key features of the project include innovative AI to enrich all aspects of pharma, from research and development to healthcare delivery and generate a sizable number of jobs, providing substantial employment opportunities for local residents, he said.
Located within the designated IT/ITeS Zone in Ameenpur, the hub benefits from exceptional infrastructure and connectivity; the project enjoys dedicated support from the Telangana government and the Software Technology Parks of India, highlighting its strategic importance, he added.
The Pharma Industry in Hyderabad contributes more than 40 percent bulk drug production in the country and is named as “Bulk Drug Capital of India ” and “Vaccine Capital of the World ”. The Innovation, Infrastructure and Inclusive growth of Hyderabad is paying rich dividends, and the state is second in manufacturing as per innovation index rankings 2022 and leading the country with highest per-capita income in 2022-23.

Read also: AP Education Minister inaugurates 100-bedded multi-specialty hospital built at cost of Rs 50 crore

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Medical Bulletin 06/ July/ 2024

Here are the top medical news for the day:

Reducing Processed Meat Intake Linked to Health Benefits: Study

Reducing consumption of processed meat by around one-third could prevent more than 350,000 cases of diabetes in over 10 years, a study published in the journal The Lancet Planetary Health suggested.

Processed meats, which often contain high levels of salt, fat, and preservatives, have been linked to an increased risk of various health issues, including heart disease, type 2 diabetes, and certain cancers, particularly colorectal cancer. By cutting down on processed meats, individuals can lower their intake of harmful substances, leading to improved cardiovascular health, better blood sugar control, and a reduced risk of cancer.

A team from the University of Edinburgh and the University of North Carolina developed a simulation tool to estimate the health impacts of reducing processed and unprocessed red meat consumption. While many studies link high processed meat consumption with chronic diseases, fewer examine multiple health outcomes, and evidence on unprocessed red meat remains limited.

Using the Centres for Disease Control and Prevention health (CDC) survey data, researchers created a representative microsimulation of the adult population to estimate the effects of reducing meat consumption by 5% to 100% on diabetes, cardiovascular disease, colorectal cancer, and mortality.

The results showed that cutting processed meat intake by 30% could prevent over 350,000 diabetes cases, 92,500 cardiovascular disease cases, and 53,300 colorectal cancer cases over a decade. Reducing both processed and unprocessed red meat by 30% could lead to 1,073,400 fewer diabetes cases, 3,82,400 fewer cardiovascular disease cases, and 84,400 fewer colorectal cancer cases. Lowering unprocessed red meat intake alone by 30% could prevent over 7,32,000 diabetes cases, 2,91,500 cardiovascular disease cases, and 32,200 colorectal cancer cases.

The findings suggested that the greater impact of reducing unprocessed red meat is due to a higher average intake compared to processed meat. However, the researchers advise caution in interpreting these estimates and call for further research.

Reference: Kennedy, J., et al. (2024) Estimated effects of reductions in processed meat consumption and unprocessed red meat consumption on occurrences of type 2 diabetes, cardiovascular disease, colorectal cancer, and mortality in the USA: a microsimulation study. The Lancet Planetary Health. doi.org/10.1016/S2542-5196(24)00118-9.

Study Finds Link Between Semaglutide and a Rare

A new study led by investigators from Mass Eye and Ear has discovered that patients prescribed semaglutide (marketed as Ozempic or Wegovy) for diabetes or weight loss had a higher risk of developing a potentially blinding eye condition called Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) compared to similar patients who had not been prescribed these drugs.

The findings were published in the journal JAMA Ophthalmology.

NAION (Non-Arteritic Anterior Ischemic Optic Neuropathy) is a relatively rare condition, affecting up to 10 out of every 100,000 people. It is the second leading cause of optic nerve blindness, following glaucoma, and the most common cause of sudden optic nerve blindness. NAION occurs due to reduced blood flow to the optic nerve head, resulting in permanent vision loss in one eye. This condition causes painless visual loss, which may progress over several days before stabilizing. There are currently no effective treatments for NAION.

For the study, researchers examined the records of over 17,000 patients treated at Mass Eye and Ear over six years since the release of Ozempic. They divided the patients into groups diagnosed with either diabetes or overweight/obesity. They compared those who had been prescribed semaglutide with those taking other diabetes or weight loss medications.

The analysis revealed a significant increase in the risk of NAION diagnoses among patients using semaglutide.

Semaglutide was developed to treat type 2 diabetes. The drug encourages weight loss, and its use has snowballed since its launch as Ozempic for diabetes in 2017. The drug was also approved for weight management, branded as Wegovy, and released in 2021.

“Our findings should be viewed as being significant but tentative, as future studies are needed to examine these questions in a much larger and more diverse population. This is information we did not have before and it should be included in discussions between patients and their doctors, especially if patients have other known optic nerve problems like glaucoma or if there is preexisting significant visual loss from other causes,” said Joseph Rizzo, director of the Neuro-Ophthalmology Service at Mass Eye and Ear.

Reference: Hathaway, J et al. “Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide” JAMA Ophthalmology DOI: 10.1001/jamaophthalmol.2024.2296

New Findings on Cellular Mechanism for Brain Energy May Improve Late-Life Brain Health

A key mechanism which detects when the brain needs an additional energy boost to support its activity has been identified in a study in mice and cells led by UCL scientists.

The findings, published in the journal Nature, could discover new therapies to maintain brain health and longevity, as other studies have found that brain energy metabolism can become impaired late in life and contribute to cognitive decline and the development of neurodegenerative disease.

Previous research has shown that astrocytes, a type of star-shaped brain cell, help supply energy to brain neurons. Astrocytes are glial cells, which are non-neuronal cells found in the central nervous system. When nearby neurons need more energy, astrocytes quickly activate their own glucose stores and metabolism. This process increases the production and release of lactate, which supplements the energy available for neurons in the brain.

In a series of experiments with mice and cell samples, researchers discovered specific receptors in astrocytes that detect and monitor neuronal activity. These receptors trigger a signalling pathway involving adenosine, a key molecule. They found that this pathway in astrocytes, which activates glucose metabolism to supply energy to neurons, is the same as the pathway that activates energy stores in muscles and the liver during exercise.

Adenosine helps astrocytes boost glucose metabolism and provide energy to neurons, ensuring that communication signals between brain cells continue smoothly, even under high energy demand or reduced energy supply.

When researchers deactivated these key astrocyte receptors in mice, the mice showed less effective brain activity, with significant impairments in overall brain metabolism, memory, and sleep. This demonstrated that the identified signalling pathway is crucial for learning, memory, and sleep.

“When our brain is active, like during mentally demanding tasks, it needs an immediate energy boost. However, the exact mechanisms ensuring this on-demand energy supply are not fully understood. Identifying this mechanism could help treat brain diseases where energy levels are low, such as neurodegeneration and dementia. Brain energy regulation declines with age and more rapidly in diseases like Alzheimer’s. Our study highlights a promising target for drugs to boost brain energy, protect brain function, maintain cognitive health, and promote brain longevity,” said the authors.

Reference: Theparambil, S.M., Kopach, O., Braga, A. et al. Adenosine signalling to astrocytes coordinates brain metabolism and function. Nature (2024). https://doi.org/10.1038/s41586-024-07611-w

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Misleading Ads Case: IMA chief tenders apology to Supreme Court

New Delhi: The chief of the Indian Medical Association (IMA) on Thursday issued a public apology for his remarks concerning a Supreme Court observation during a case involving the IMA. He expressed regret for his statement, clarifying that it was never his intention to undermine the dignity of the court.

According to a PTI report, “The IMA National President Dr R V Asokan has released an apology regretting his statement to the press regarding a comment by the Supreme Court while IMA was party to the case,” the statement issued by the doctors’ association said.

The Indian Medical Association (IMA) was equally concerned about the issues of malpractice, Dr Asokan said in the statement referring to the April 23 order in which the apex court during the hearing of a matter related to Patanjali Ayurved Ltd’s misleading advertisements case had observed that it was of the opinion that IMA also needs to put its house in order. 

Also Read:SC refuses to accept IMA president’s Apology, Reserves verdict on Patanjali Misleading Ads case

In an affidavit filed in the top court, Dr Asokan had also tendered an unconditional apology for his statement against the Supreme Court.

“IMA has filed a writ petition before the Supreme Court against misleading advertisements and malicious campaigns by some persons and entities against modern medicine professionals. With reference to certain statements made by me during an interview with PTI News, I have expressed regret to the Supreme Court and have also submitted my affidavit to the court for tendering my unconditional apology,” Dr Asokan said. 

“I never had any intention to lower the majesty or dignity of the Supreme Court,” he added in his apology.

“There are several complaints relating to the alleged unethical acts on the part of the members of the Association who are abusing the trust reposed in them by patients and not only prescribing prohibitively expensive medicines, but also recommending avoidable/unnecessary investigations as a part of the line of treatment, for purely extraneous considerations,” the bench had said, news agency PTI reported. 

Constant updating and dissemination of ethical practices was one of the main activities of the IMA, Dr Asokan said.  

Recently, the IMA engaged patient groups in a dialogue for addressing the concerns of patients and a joint declaration was released in Bangalore, the statement said.

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Yogi Govt initiates development of Lalitpur Bulk Drug Pharma Park into pharma hub

UP: The Yogi Adityanath government has started plans to provide world-class common infrastructure facilities (CIF) to the Bulk Drug Pharma Park in Lalitpur. The park will be developed over an area of 1,120 acres under the PPP model.

According to a government spokesperson, the Uttar Pradesh State Industrial Development Authority (UPSIDA) has initiated preparations for the development of the park. 

In this sequence, UPSIDA has issued a Global Expression of Interest (EOI) for the development of the park. This strategic move aims to establish the park as a hub for manufacturing crucial components like ‘Key Starting Materials’ (KSM) and ‘Active Pharmaceutical Ingredients’ (API), pivotal for the pharmaceutical sector’s advancement.

According to IANS report, Chief Minister Yogi Adityanath’s vision for this project is to develop the area to meet the country’s pharma needs. The goal is to produce high-quality, affordable medicines and increase India’s self-reliance in bulk drug production. To achieve this, the development of the Bulk Drug Park in Lalitpur is being promoted.

An Expression of Interest (EOI) has been issued to attract global leaders in the pharma sector for the development of the Lalitpur Bulk Drug Park.

According to the action plan prepared for the park’s development, the path will be paved for the development of large-scale industrial townships, sectoral-specific industrial parks and other industrial areas.

As per the EOI issued by UPSIDA, a developer agency will be determined to complete all these development works.

It is worth mentioning that the Lalitpur Bulk Drug Pharma Park will be connected to world-class basic infrastructure and excellent connectivity through road and rail networks, ensuring convenient logistics and smooth transportation.

The park will serve as a state manufacturing powerhouse for the pharma sector.

The Lalitpur Bulk Drug Pharma Park will also serve as the state manufacturing powerhouse for pharmaceutical products. Additionally, it will serve as an incubator for emerging pharmaceutical and bulk drug manufacturing industries in Lalitpur. It will be equipped with several world-class facilities, including standard practices like Zero Liquid Discharge for chemical discharge management.

The park will be equipped with solid waste management and incinerator facilities, a stormwater drainage network, common solvent storage systems, and solvent recovery and distillation plants. It will include steam generation with inclusive cooling towers, common warehouses, dedicated power stations and distribution systems, and facilities for raw, portable, and demineralized water.

Additionally, advanced laboratory testing centre, emergency response centre, hazardous operation audit centre, and a Centre of Excellence will also be developed here.

Read also: UP Govt launches mass drug administration in 17 districts to eradicate filariasis

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Telangana doctor battling depression jumps to death from 8th floor of apartment

Hyderabad: In an unfortunate incident, a 29-year-old lady doctor allegedly committed suicide by jumping from the 8th floor of her apartment at Nagole in LB Nagar near here on Thursday. 

According to her parents, the doctor was suffering from depression. They told the police that she was facing some mental health issues and was undergoing treatment. 

Also read- 38-Year-Old Doctor Falls To Death From 4th Floor Of Nellore Medical College

No suicide note was found at the scene and the police confirmed that the doctor who had completed her MBBS, was suffering from psychological depression. 

As per a UNI report, the incident took place at around 11 am when her husband was out of the station due to some work. She took the extreme step and allegedly jumped from the eighth floor of her apartment building in Nagole where she was staying along with her parents.  

Due to the height and the intensity of the fall, the doctor died on the spot. No suicide note was found at the scene, according to the authorities.  

Police registered a case and an investigation is underway.  

Also read- Trichy Doctor Allegedly Commits Suicide By Consuming Pesticide

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Cancelling NEET 2024 would jeopardize career prospects of honest qualified candidates: Centre, NTA tell Supreme Court

New Delhi: In its affidavit filed in response to one of the petitions in the top court, the National Testing Agency told the Supreme Court recently that cancellation of the controversy-ridden NEET 2024 examination would be hugely counterproductive and significantly harmful to the larger public interest, especially to the career prospects of those who cleared it.

According to the PTI report, the NTA, which conducts the NEET-UG examination, said the alleged incident/attempt of leak does not seem to have any bearing on the conduct of the entire examination held on May 5, as the number of candidates found to be involved by the investigating agencies is minuscule compared to number of candidates who appeared.

“The cancellation of the entire examination on the basis of the aforesaid factor, would be hugely counterproductive and significantly harmful to the larger public interest, especially to the career prospects of the qualified candidates,” it said.

Scrapping the NEET-UG, 2024 exam in entirety would “seriously jeopardise” lakhs of honest candidates and not be rational in the absence of any proof of large-scale breach of confidentiality, the Centre also told the apex court on Friday in a separate affidavit, adds PTI.

Also Read:Re-NEET unreasonable, harsh for honest hardworking students! 56 successful candidates move Supreme Court to Stop NTA from cancelling NEET 2024

The agency said the NEET-UG 2024 exam was carried out fairly and with due confidentiality in entirety without any illegal practices and the claim of “mass malpractice” is “completely unfounded, misleading, and lacks any basis”.

This year’s NEET UG 2024 exam was mired in controversies after a paper leak scam came to light. Medical Dialogues had earlier reported that around 13 people, including four examinees and their family members, were arrested in Bihar for their alleged involvement in the paper leak of the NEET-UG exam. Patna police sources had previously claimed that the NEET-UG question papers along with their answers were provided to around 20 aspirants a day before the date of the exam i.e. May 5, 2024.

Then, the Economic Offences Unit (EOU) of Bihar Police, which took over the investigation, revealed that the brokers involved in the NEET paper leak scam took between Rs 30 lakh to Rs 50 lakh from each of the medical aspirants in exchange for giving them the question paper of the NEET UG 2024 question paper ahead of the examination.

Multiple pleas have been filed before the High Courts and the Supreme Court seeking an investigation into the alleged paper leak scam. Some of the pleas demanded the scrapping of the NEET UG 2024 exam and holding a retest.

Meanwhile, during the case proceedings, NTA earlier decided to withdraw the grace marks awarded to 1563 candidates and hold an optional retest for those candidates. Those who did not opt for the retest were allowed to retain their original marks, without the grace marks.

The matter is now being investigated by the Central Bureau of Investigation (CBI). Central Government on June 22, 2024, handed over the charge of investigating in the alleged irregularities in the NEET UG 2024 examination to the Central Bureau of Investigation (CBI).

“Certain cases of alleged irregularities / cheating / impersonation / malpractices have been reported. For transparency on the conduct of the examination process, the Ministry of Education, Government of India after a review has decided to entrust the matter to the Central Bureau of Investigation (CBI) for a comprehensive investigation,” the Ministry of Education stated in a release.

Earlier, while considering the NEET-related pleas, the Supreme Court had refused to defer the counselling/seat allotment process scheduled to commence on July 6. However, the bench had orally observed that the admissions would be subject to the final outcome of the petitions and if the exams were set aside, the counselling would get invalidated consequentially.

The Top Court had also expressed its concern over the alleged discrepancies in the NEET UG 2024 exam. The Court had noted that even ‘0.001& negligence’ in conducting the NEET-UG 2024 exams would be looked into with all seriousness considering the immense labor put in by the candidates for the prestigious examination.

Recently two candidates Kritika Garg and Priyanjali Garg approached the Apex Court opposing the proposal to cancel the NEET exam and hold a retest. Hailing from Meerut, these candidates secured Rs 705 and 690 marks respectively.

Approaching the Apex Court bench, they argued that students who have prepared for years should not be put to the trouble of appearing in the exam again. These applicants further contended that holding a retest for the NEET UG 2024 exam would not only be “unfair” to most students but would also cause hardship to their families.

Also Read: Scrapping NEET 2024 for Mischief of a Few would be Unjust: 2 Candidates File Application before Supreme Court

NEET-UG retest result

The Centre and the NTA had, on June 13, told the court that they had cancelled the grace marks awarded to 1,563 candidates. They were given the option to either take a re-test or forgo the compensatory marks awarded for loss of time.

The NTA announced the revised rank list on Monday after issuing the results of the re-test held on June 23.

A total of 67 students had scored a perfect 720, unprecedented in the NTA’s history, with six from a Haryana centre figuring in the list, raising suspicions about irregularities in the examination held on May 5. It has been alleged that grace marks contributed to 67 students sharing the top rank.

The number of candidates sharing the top rank in the NEET-UG reduced to 61 from 67 as the NTA announced the revised results on Monday.

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Survey shows men need to do more to prevent cancer

American men are blowing their best chance to head off cancer or spot it early, when it’s easiest to treat, a new survey warns.

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People with diabetes who are treated with insulin have a 60% increased risk of serious injury, finds study

People with diabetes who are treated with insulin have more than a 60% increased risk of being hospitalized for injuries which include head and neck trauma, and burns, compared to the general population, according to a concerning new study by Australian researchers.

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