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Gyaltsuen Jetsun Pema Wangchuk Mother And Child Hospital integrated by PM Modi

Prime Minister Narendra Modi inaugurated the state-of-the-art hospital, Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital built with Indian assistance showcasing the robust development cooperation between India and Bhutan.

The Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital is a state-of-the-art 150-bedded facility that has been built with the assistance of the Government of India in Thimphu.

For more information, click on the link below:

PM Modi Inaugurates Gyaltsuen Jetsun Pema Wangchuk Mother And Child Hospital

What made Sadhguru lose his Consciousness? Subdural Hematoma: A Neurological Emergency – Dr Rahul Chawla

Recently, renowned Spiritual Guru and founder of the Isha Foundation, Sadhguru, underwent surgery for bleeding in the brain, as reported by the media. The condition is known as Subdural hematoma (SDH).

SDH is a neurological emergency condition characterized by the accumulation of blood between the dura mater and the arachnoid membrane, two layers of the meninges that cover the brain. Here, the blood accumulation occurs outside the brain parenchymas and produces neurological symptoms due to the compression of underlying structures of the brain. Acute severe SDH can be life-threatening, with significant morbidity and mortality if not promptly treated.

Etiology and High Risk Factors

Subdural hematomas can occur due to various reasons:

1. Head Trauma, including falls, motor vehicle accidents, and assaults. Chronic alcohol consumers are especially predisposed to SDH due to trivial trauma that patients might not be aware of.

2. Thrombocytopenia or Low platelet counts predispose the patients to bleeding tendencies.

3. ⁠Chronic Liver Disease

4. ⁠Use of antiplatelet or anticoagulant therapies: Patients on anticoagulant medications such as Warfarin with INR above 3 are at risk for SDH or any internal bleeding. Patients on aspirin are also known to have a risk for SDH.

5. Chronic subdural hematomas can develop spontaneously in the elderly due to the tearing of bridging veins with minor trauma or even without any apparent injury.

Symptoms

The symptoms of SDH include headaches, confusion, vomiting, weakness on one side of the body, difficulty speaking or understanding speech, seizures, behavioural changes, impaired awareness and loss of consciousness.

Diagnosis

Any patient with a history of head trauma with acute onset headache with red flags such as recurrent vomiting, seizures, focal neurological deficit, abnormal behaviour etc. should undergo NCCT Brain to rule out any space-occupying lesion or bleeding inside the brain, whether intraparenchymal haemorrhage or SDH.

NCCT Brain should also be considered in the absence of a red flag on history, but neurological examination is suggestive of signs of raised intracranial pressure, such as altered mental status, pupil abnormalities, and focal neurological deficits.

Brain imaging (NCCT Brain or MRI Brain) helps determine the size, location and extension of SDH, and the management can be decided based on findings on imaging.

Management of SDH

1. Monitoring: Patients with acute SDH are required to be admitted and monitored for any change in sensorium, development of any new onset neurological deficit.

2. ⁠Medical Management: Patients are managed with anti-seizure medications and decongestant therapy. Patients can be considered for surgery if a patient has severe SDH, altered mental status or development of neurological deficit.

3. Surgerical therapy: Patients undergo Burr hole surgery or Craniotomy depending on the size of SDH and neurological status of the patient.

What did we learn from Sadhguru?

Sadhguru had been having severe headaches 3 weeks prior, but he neglected the symptoms and continued with his commitments. Since he was having chronic or subacute SDH, the symptoms evolved rather slowly over 2 weeks. Only when he started developing neurological deficits and altered consciousness did he decide to get admitted and operated upon as per the advice of treating physicians.

Hence, it is important to listen to your body, identify symptoms, seek advice from expert doctors, and not become disillusioned by any alternative therapy.

Any patient with new onset severe headache in the presence of any of the red flag signs such as diminution in vision, altered behaviour, seizures, neurological deficit in the form of limb weakness, speech abnormalities or impaired consciousness- should seek urgent help from hospitals with neurological emergency care facilities.

If you know anyone who has these symptoms, get him/her to the hospital at the earliest.

Be Aware! Stay Healthy!

Disclaimer: The views expressed in this article are of the author and not of Medical Dialogues. The Editorial/Content team of Medical Dialogues has not contributed to the writing/editing/packaging of this article.

Vision Loss Due to Undiagnosed Malignancy in Optic Nerve, NCDRC slaps Rs 20 lakh compensation for negligence

New Delhi: Holding that due to an incorrect MRI scan, there was a delay in treatment which ultimately resulted in loss of vision in the patient’s left eye, the National Consumer Disputes Redressal Commission (NCDRC) recently upheld the order passed by Chandigarh State Commission directing a diagnostic and scanning centre to pay Rs 20 lakh compensation to the patient.

It was alleged that the vision loss was on account of the optical nerve being infected with a malignant growth which was not depicted in the report.

The complainant/patient (minor) filed a consumer complaint through his father against the scanning centre for alleged negligence by the doctor running the scanning centre contending that the report of imaging dated 13.01.2007 was a wrong report, contrary to the images that existed and which were necessary to be mentioned for a proper diagnosis.

The complainant alleged that because of the incorrect and wrong report, the treatment of the patient could not be undertaken timely and was delayed. This ultimately resulted in the loss of vision in the patient’s left-eye. The loss was on account of the optical nerve being infected with a malignant growth which was not depicted in the report dated 13.01.2007.

It was claimed by the complainants that had the correct radiological symptoms been recorded, the patient would have immediately undertaken the follow-up treatment which could not be accomplished due to this incorrect reporting by the diagnostic centre.

After considering the complaint and examining the evidence, facts and sequence of events, the State Commission, Chandigarh concluded that there was deficiency and a lapse amounting to negligence on the part of the scanning centre by giving a wrong MRI report. Holding the scanning centre liable to compensate the complainant on account of loss of vision of the left eye of the complainant, the State Commission ordered the scanning centre to pay Rs 20 lakh compensation and Rs 10,000 litigation costs to the complainant.

Challenging the order of the State Commission, the Scanning Centre appealed to the National Consumer Disputes Redressal Commission (NCDRC). It was argued by the counsel for the Scanning Centre that the Complainant along with his guardian came to the appellant Clinic/Scanning Centre on their own without any prescription or medical advice from any medical practitioner and requested for an ordinary MRI Scan.

The Scanning Centre argued that the complainant’s father was advised to seek a specialist’s opinion for specifying the area and type of scan required to be done but the he did not adhere to this and insisted on the doctor of the scanning centre conduct a routine MRI of the brain without any injection of any medicine. The MRI Scan was done and the father was advised to consult a specialist doctor for proper medical treatment.

Referring to the MRI report dated 13.01.2007, the scanning centre argued that the report did not indicate any abnormality in the ‘Sella’ region, orbits and retroorbital spaces. Apart from this, the scanning centre further argued that the delay in the treatment initiation could not be attributed to the initial MRI report.

The counsel for the scanning centre referred to the eye examination at Grewal Eye Institute on the same day where the vision of the right and the left eye was reported to be 6/5 and 6/6. Referring to this, the counsel argued that there was no abnormality of vision as of the date when the eyes were examined at Grewal Eye Institute and therefore, the imaging report did not suffer from any infirmity nor could it be suspected to be wrong.

Further, the counsel referred to the eye examination at Prakriti Brain & Nerve Research Centre on 19.01.2007 where a provisional diagnosis at that stage indicated a suspicion about a sharp decline in the vision but the same was suspected on diagnosis due to Mild Refractory Errors and therefore, advice was given for other clinical and medical examination. Referring to these, it was argued that even these doctors could not locate any indication of a suspected malignant abnormal growth. Reliance was also placed on the report of an eminent neurologist Dr. Chopra who provisionally diagnosed that there were no neuro defects and it was a possible headache or migrane and went to the extent of saying that the behaviour of the patient could be functional.

Referring to these reports, the counsel for the scanning centre argued that there were no symptoms to possibly detect or suspect any other possibility at that moment.

Later, the patient was taken to the Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh and was examined as an out-patient on 31.01.2007 with advice to be checked for Relative Afferent Pupillary Defect (RAPD). The follow-up review was undertaken and on 05.02.2007, he was examined in the neurology department of PGIMER, where Dr. Lal suspected a possible growth on the left side and advised an MRI.

As per the counsel for the scanning centre, this was the first clinical diagnosis by an expert in that field suspecting a growth. Following this, the complainant and his father came to the appellant Scanning Centre and on 05.02.2007 a Contrast MRI was conducted on the said prescription. On this, the contrast MRI according to the appellant, disclosed a growth enclosing and superimposing the optic nerve of the left eye of the complainant measuring 5.28 x 3.8 x 3.87 cms. The report also categorically stated that the said growth was causing bilateral optic nerve compression in the regions concerned. While reciting the impression it was also recorded that the growth was most likely an aggressive fungal infection (invasive aspergillosis).

The complainant alleged that the doctor took the earlier reported dated 13.01.2007 and applied a whitener over the word “Sella” in that report. The complainant alleged that this was done intentionally, possibly to reflect as if no imaging was done with regard to the Sella region. However, the counsel for the scanning centre argued that this allegation was incorrect as the said report was in the custody of the guardian of the complainant.

Meanwhile, the counsel for the patient argued that the initial MRI report was incorrect and the doctor failed to identify the malignant growth compressing the optic nerve. Later examinations and reviews of the same MRI scan confirmed the presence of the growth, indicating negligence in reporting the initial MRI.

It was further contended that the disease aggravated between 13.01.2007 to the second contrast MRI conducted on 05.02.2007 and this ultimately badly affected and compressed the optic nerve of the left eye. The severity of this aggressive development was such that the patient virtually lost his left eye-sight due to this negligence.

While considering the matter, the top consumer court noted that the initial MRI was done voluntarily by the patient’s father as a precautionary measure, without any prescription or provisional symptoms. There was no indication of any growth in the ocular region and even subsequent examinations did not initially detect any suspected growth.

However, a growth was suspected after the child underwent a more detailed examination at PGIMER, Chandigarh where the doctor advised for a contrast MRI. This second MRI confirmed that there was a growth compressing the optical nerves.

The top consumer court referred to subsequent reports from medical institutes confirming the existence of a growth even in the initial MRI scan dated 13.01.2007.

“…the 13.01.2007 report was not correct and this error was not an error of judgment on the part of the Appellant but was sheer negligence. Had the report been correctly recorded or any doubt expressed about any growth, the same would have been a different story. But on a perusal of the report dated 13.01.2007, it is clear that the Appellant had clearly opined that there was no abnormality seen in the ‘SELLA’ region. This is contrary to what was confirmed later on 09.12.2009 by the Rajiv Gandhi Cancer Institute, even though the other doctors who had examined the Complainant between 13.01.2007 and 05.02.2007 had not been able to suspect the same,” opined NCDRC.

Upholding the opinion expressed by the State Commission, the NCDRC bench noted,

“The report on imaging is exclusively a responsibility of the Appellant and therefore, in view of what has been said in the Reports dated 09.12.2009 of Rajiv Gandhi Cancer Institute and Research Centre and 28.12.2010 of the Grewal Eye Institute confirms that the report about the imaging as transcribed and recorded on 13.01.2007 was misleading. There is no evidence or plausible explanation contradicting the said reports by the appellant. This negligence, therefore, cannot be ruled out and the preponderance of probabilities given the circumstances aforesaid lead to the conclusion that the Appellant was negligent in discharging the professional duties that is expected of a medical practitioner of the field possessed of ordinary skills. Consequently, the conduct and omission of the Appellant Dr. ***, clearly qualifies as a negligence on her part. Therefore, the State Commission has rightly proceeded to hold her liable.”

Although NCDRC acknowledged the difficulty in determining the quantum of compensation, it upheld the Rs 20 lakh compensation awarded by the State Commission.

“In my considered opinion, keeping in view the life-span of the child who may now have joined the legal profession as orally urged by the learned Counsel for the Appellant, has suffered a loss including physical harassment and of course will continue to be agonized throughout his life. It is, thus, not only the actual loss suffered by him but also the expected disadvantages which he is likely to suffer in future. With a vision of only one eye, he is bound to face disadvantages in his legal profession as well as his personal life. The prospects of a marriage and future employment would be marred by this handicap. Considering the age-span and the overall circumstances of the case and also the fact that no Appeal for enhancement has been filed by the Complainant, I see no reason to interfere with the amount of Rs.20 lacs awarded as compensation to the Complainant which appears to be just and reasonable,” it observed.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/ncdrc-scan-centre-234895.pdf

Also Read: Failure to Detect Foetal Anomaly: NCDRC Slaps Rs 15 Lakh Compensation on Hospital, Radiologist

Lucknow hospitals on high alert, 100 beds reserved to manage emergencies during Holi

Lucknow: To provide swift treatment to those getting injured in accidents on Holi, the Health Department has put all hospitals in Lucknow on alert and asked all the doctors and paramedical staff to remain on duty on March 24 and 25 respectively.

Specifically asking the healthcare community for assistance, Deputy CM Brajesh Pathak has directed the doctors and hospital staff at all government hospitals in the emergency department to be available on duty for 48 hours. In addition, he also asked hospitals to store essential medicines.

Alerting government hospitals to enhance their emergency services during Holi, the government have reserved collectively 100 beds at various government hospitals on Sunday and Monday to avoid any inconvenience to the patients in cases of an emergency.

Also read- PM Modi Inaugurates Gyaltsuen Jetsun Pema Wangchuk Mother And Child Hospital

The Trauma Centre at King George’s Medical University (KGMU) Lucknow, has allocated 20 beds for medical emergencies. Senior residents from each department have been assigned duties to ensure doctors from all branches remain on duty throughout Holi.

Similarly, the medical teams at Ram Manohar Lohia Institute of Medical Sciences, Civil, and BRD Mahanagar hospitals have been notified, and the civil hospitals have allocated 15 beds specifically for emergency cases.

A total of 44 ambulances (on emergency numbers 102 and 108) will be on the road throughout the day. In cases of emergency, people can dial 108 or 112 to get help to reach a medical centre.

“In Lucknow, 44 ambulances under 108 service will remain on high alert. Also, 34 ambulances under 102 service for pregnant women will also be on alert,” said TVSK Reddy, senior vice president, of Emri Green Health Services which runs 108 ambulance service in the state.

In case of an injury, individuals can seek assistance by contacting the helpline at 9118455570, where medical professionals on emergency duty will respond to the call.

Speaking to HT, Dr Manoj Agrawal, chief medical officer of Lucknow said, “All hospitals have been asked to ensure that senior consultants and para-medical staff are available to deal with any sort of medical emergency, particularly on Sunday and Monday 48 hours. This is in addition to the regular facilities available in emergency and OPD,” said Dr Manoj Agrawal, chief medical officer of Lucknow.

“Duty of senior residents from each department unit has been assigned so that doctors from all branches remain on duty during Holi. The peak starts in the afternoon. Hence, all have been asked to remain on high alert,” said Prof Sandip Tiwari, head of the Department of Trauma Surgery and chief medical superintendent of the trauma centre at KGMU.

“An eye specialist, a general surgeon, a skin specialist and an orthopaedic surgeon will be available round the clock. Our special focus is on ensuring a team of different specialists on Monday particularly as past experiences show more than usual accident cases come on the Holi day,” said Dr NB Singh, chief medical superintendent, of Balrampur Hospital.

“Beds will be reserved to deal with emergency cases during the two days of festivities. Our teams have been asked to stay on alert,” said Dr Ajai Shankar Tripathi, medical superintendent, of Lok Bandhu Hospital.

Also read- Sakra World Hospital To Set Up 500-Bed Hospital In Bengaluru For Rs 1000 Crore

Medical Bulletin 23/ March/ 2024

Here are the top medical news for the day:

Sedentary lifestyle may affect risk of erectile dysfunction, finds study

According to a study published in the journal Andrology, a higher genetic susceptibility to leisure time may be associated with a greater risk of erectile dysfunction in men.

The prevalence of ED varies worldwide, with studies suggesting rates ranging from 5% to 25% in men aged 40 and older. Erectile dysfunction (ED) can stem from various factors, including physical conditions such as cardiovascular disease, diabetes, obesity, hormonal imbalances, and neurological disorders. Psychological factors like stress, anxiety, depression, and relationship issues can also contribute.

Leisure time can indirectly affect erectile dysfunction through its impact on overall health. Engaging in sedentary activities for a longer time can increase the risk of obesity, cardiovascular disease, and diabetes, all of which are significant contributors to ED.

In the study, researchers analysed data of more than 200,000 men and found that each 1.2 hour increase in leisure computer usage predicted 3.57-fold greater odds of erectile dysfunction. There was no evidence to suggest that watching television or driving for leisure increased the risk of erectile dysfunction. Also, computer use was not linked with depression, anxiety, or markers of blood vessel health, but it was associated with lower levels of follicle-stimulating hormone, which plays a role in sexual development and reproduction in both males and females.

The study revealed substantial evidence for a positive causal association between leisure time and the risk of erectile dysfunction. Extended computer usage for leisure raises the likelihood of developing erectile dysfunction, which may be associated to lower hormones that aid in sexual development.

The study’s findings suggested that moderate physical activity may be useful in correcting the dysfunction by improving cardiovascular health and balancing hormones.

Reference: Zhao Huangfu, Xinxin Gan, Yiren Yang, Qingyang Pang, Baohua Zhu, Xiao Zhang, Linhui Wang; A Mendelian randomization study on causal effects of leisure sedentary behavior on the risk of erectile dysfunction; Journal: Andrology; DOI:10.1111/andr.13611

Could antibiotics help fight COVID-19?

New research published in the Journal of Medical Virology indicated that antibiotics can effectively target bacteria in the gut that harbour the virus that causes COVID-19 and produce toxin-like peptides that contribute to COVID-19-related symptoms.

The bacteriophage behaviour of SARS-CoV-2 during the acute and post-COVID-19 phases appeared to be an important factor in the development of the disease. The early use of antibiotics seemed to be crucial to inhibit disease progression—to prevent viral replication in the gut microbiome, and control toxicological production from the human microbiome.

To study the impact of specific antibiotics on recovery from COVID-19 and long COVID (LC) taking into account: vaccination status and time of initiation of antibiotic therapy, researchers recruited a total of 211 COVID-19 patients in the study: of which 59 were vaccinated with mRNA vaccines against SARS-CoV-2 while 152 were unvaccinated. Patients were enrolled in three waves: from September 2020 to October 2022, corresponding to the emergence of the pre-Delta, Delta, and Omicron variants of the SARS-CoV-2 virus.

In the analysis, both vaccinated and unvaccinated groups had a median illness duration of 7 days, the median illness duration for the pre-Delta and Delta waves was 8 days, while it was shorter, 6.5 days, for Omicron.

The results showed that patients with comorbidities had a significantly longer disease duration: median 8 days compared to 7 days for those without comorbidities. Early initiation of antibiotic therapy resulted in a significantly shorter recovery time. Concomitant use of antibiotics did not reduce disease duration and in multivariate analysis prolonged the disease. A subgroup of 42 patients receiving corticosteroids for a median of 3 days had a longer recovery time compared to others.

The findings revealed a statistically significant reduction in recovery time among patients who received early antibiotic treatment. Early initiation of antibiotics played a crucial role in maintaining higher levels of blood oxygen saturation. In addition, it is worth noting that a significant number of patients who received antibiotics in the first 3 days and for a duration of 7 days, during the acute phase did not develop Long Covid.

Reference: Carlo Brogna, Luigi Montano, Maria Elisabetta Zanolin, Domenico Rocco Bisaccia, Gianluca Ciammetti, Valentina Viduto, Mark Fabrowski, Abdul M. Baig, Joachim Gerlach, Iapicca Gennaro, Elio Bignardi, Barbara Brogna, Aquilino Frongillo, Simone Cristoni, Marina Piscopo; A retrospective cohort study on early antibiotic use in vaccinated and unvaccinated COVID-19 patients; Journal: Journal of Medical Virology; DOI: 10.1002/jmv.29507

Does diet play a role in Vitiligo?

In a recent study published in the Journal of Cosmetic Dermatology, researchers combined available data to explore the impacts of diet and nutritional interventions against vitiligo.

Vitiligo is a rare autoimmune disorder characterized by the loss of skin pigmentation in patches or blotches, usually around the mouth, hair, and eyes. It is estimated to affect between 0.004% and 2.28% of the global population, and while phototherapy and pharmacological interventions can reduce symptom visibility, no cure for the condition currently exists. Heightened concentrations of reactive oxygen species (ROS) in tandem with reduced efficacy of the body’s normal antioxidant mechanisms is assumed to substantially exacerbate the disease.

As is the case in other chronic conditions characterized by altered ROS metabolism (some cancers and neurodegenerative conditions), diets are being explored for their potential antioxidant properties.

In the study, researchers discussed up-to-date outcomes from studies and publications exploring the association between diet and vitiligo. Two independent reviewers collected papers from online scientific repositories, while in another pilot study, the effectiveness of high-dose oral vitamin D supplementation on vitiligo repigmentation was investigated in 16 individuals with vitamin D deficiency vitiligo. Over half of the patients experienced 26%–75% repigmentation after consuming 35,000 IU daily.

The results highlighted the critical role of ROS and the body’s antioxidant mechanisms in the development and progression of vitiligo. ROS-producing heavy metals like cadmium (Cd), Mercury (Hg), and lead (Pb) are implicated as disease-causing substances. In contrast, the roles and impacts of micronutrients remain poorly understood.

Furthermore, diets and nutritional interventions rich in ROS-depleting molecules (such as vitamin C, B12, and D, polyunsaturated fatty acids (PUFAs), and antioxidants are observed to trigger beneficial vitiligo outcomes and reduce the burden of metabolism, cellular deterioration, and oxidative stress brought about by ROS.

The study concluded that while dietary interventions cannot be thought of as a standalone therapy, they still make a case for being used as adjuncts. Many food items that have antioxidants can be used in therapy for this disease, because of the pathophysiological nature of the disease.

Reference: Hadi, Z., Kaur, R., Parekh, Z., Khanna, S., Bin Khalil, A. B., Abbasi, H. Q., Ashfaque, F., Shah, D., Patel, V. J., & Hasibuzzaman, M. A. Exploring the impact of diet and nutrition on vitiligo: A systematic review of dietary factors and nutritional interventions. Journal of Cosmetic Dermatology, DOI – 10.1111/jocd.16277

West Bengal Surgeons successfully remove glass bottle from man’s rectum through innovative approach

Midnapore: In a successful and unique operation, a team of doctors at Midnapore Medical College and Hospital surgically removed a glass bottle along with a cork from a man’s rectum by squeezing out the bottle via the rectum on Tuesday.

The man reported to be in his 30s accidentally inserted a glass bottle inside him following which the doctors noticed through x-ray that the object had moved further upwards encouraging them to perform surgery immediately after an attempt to remove the object without surgery failed.

The surgical team consisted of Dr Sumitava Pachal, Dr Rafi Moazzam, Dr Saurav Kanji, and Dr Aftab Alam. They effectively extracted the glass bottle and cork from his body, ensuring the integrity of the gut and the safety of the rectum throughout the procedure.

Also read- Living Recipient Receives World’s First Genetically-Edited Pig Kidney Transplant At Massachusetts General Hospital

The incident came to light when the patient visited the hospital’s emergency ward with complaints of extreme abdominal pain and problems with bowel movements. Although he had done an x-ray from a private lab, the doctors at the hospital conducted a second x-ray to determine the severity of the case.

In the second x-ray, the doctors noticed a bottle-shaped object lodged in his pelvis in the lower abdomen region which had moved further upwards. To remove the object from his body through surgery as they failed to do it manually, the doctors took an innovative approach instead of performing laparotomy which involved cutting open the patient’s stomach and pushing the object out via the rectum.

On March 19 at midnight, the doctors’ team successfully removed the glass bottle from his rectum by squeezing out the bottle via the rectum that reduced the patient’s recovery time from four months to less than a week

Speaking to The Telegraph in detail Dr Sumitava Pachal, the lead surgeon of the operating team said, “When we asked him several times about what exactly happened, the patient told us that he accidentally inserted a glass bottle inside him and insisted that no one else had forced or manipulated him into doing this.”

“Our biggest fear was what if the glass bottle breaks amid our attempts to extract it out. The usual operating procedure entails cutting the rectum and removing the bottle, just like delivering a baby from a woman’s uterus. But, we decided to adopt an innovative approach where we had to squeeze out the bottle via the rectum, literally like a tomato ketchup sachet”, he added.

“Rectal foreign body cases are not common in a government hospital’s emergency ward, except in psychiatric patients. We will discharge him within a day after talking to the neighbours who brought him to us as he lives alone,” said Dr Pachal.

Also read- Sri Sathya Sai Health And Education Trust, The Hans Foundation Collaborate For 300 Cost-Free Heart Surgeries For Children

Novo Nordisk Awiqli recommended for approval for diabetes by European regulatory authorities

Denmark: Novo Nordisk has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Awiqli (the brand name for once-weekly basal insulin icodec) for treatment of diabetes in adults.

The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial programme. Once-weekly basal insulin icodec achieved superior blood sugar reduction (measured by a change in HbA1c) and superior Time in Range (time spent within recommended blood sugar range), compared with daily basal insulin in people with type 2 diabetes. In people with type 2 diabetes who have not previously been treated with insulin, overall observed rates of clinically significant or severe hypoglycaemia were below one event per patient-year of exposure with both once-weekly basal insulin icodec and comparators. In people with type 1 diabetes, once-weekly basal insulin icodec demonstrated non-inferiority in reducing HbA1c with a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia compared with insulin degludec. Across the programme, once-weekly basal insulin icodec appeared to have a safe and well-tolerated profile.

“We believe that by reducing the number of basal insulin injections from seven to one per week, Awiqli has the potential to have a significant impact and improve treatment for people living with diabetes,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We are committed to driving innovation in diabetes treatment, and Awiqli has the potential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment.”

Novo Nordisk expects to receive final marketing authorisation from the European Commission within approximately two months.

Awiqli is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection.

The ONWARDS clinical development programme comprised six phase 3a global clinical trials, which investigated the efficacy and safety of once-weekly basal insulin icodec, involving more than 4,000 adults with type 1 or type 2 diabetes, including a trial with real-world elements.

Novo Nordisk is a global healthcare company, founded in 1923 and headquartered in Denmark. The Company markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).

USFDA grants full approval for Abbvie Elahere for certain ovarian cancer patients

North Chicago, Ill.: AbbVie has announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as ELAHERE.

“The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. ELAHERE is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this difficult-to-treat malignancy,” said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie.

ELAHERE was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial. This trial compared ELAHERE to investigator’s choice (IC) of chemotherapy in patients with platinum-resistant ovarian cancer (PROC) whose tumors express high levels of FRα and who have been treated with up to three prior therapies. The primary endpoint of MIRASOL was progression-free survival (PFS) by investigator assessment and key secondary endpoints included objective response rate (ORR) and overall survival (OS).

“As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, ELAHERE provides an effective new option for patients with folate receptor alpha positive tumors. These patients previously had very limited options and ELAHERE changes that,” said Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator.

MIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator’s choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRα, using the Ventana FOLR1 Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). The trial enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitor.

Based on current results:

OS hazard ratio (HR) was 0.67 (95% confidence interval [CI]: 0.50, 0.88; p=0.0046), representing a 33% reduction in risk of death in the ELAHERE arm compared to the IC chemotherapy arm.
PFS HR was 0.65 (95% CI: 0.52, 0.81; p<0.0001), representing a 35% reduction in the risk of tumor or cancer progression in the ELAHERE arm compared to IC chemotherapy.
ELAHERE showed overall fewer Grade 3+ adverse events and a lower rate of discontinuations due to adverse events when compared to the IC chemotherapy control group.

Ovarian cancer is the leading cause of death from gynecological cancers in the United States. Each year, approximately 20,000 patients are diagnosed. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with low response rates, short durations of response, and significant toxicities.

ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

The Marketing Authorization Application (MAA) for ELAHERE in Europe has been accepted by the European Medicines Agency (EMA). Regulatory submissions for ELAHERE are also under review in multiple other countries.

No need to pay requisite fee if already paid: NMC tells medical colleges on submission of annual declaration

New Delhi: Through a recent notice, the National Medical Commission (NMC) has told the medical colleges they need not pay the requisite fee for Renewal, Recognition or Continuation of Recognition for the academic year 2024-25, if they have already made the payment.

Earlier, stating that the submission of the Annual Declaration Form on the National Medical Commission’s (NMC) portal is mandatory for annual renewal of permission of undergraduate MBBS seats, the Undergraduate Medical Education Board (UGMEB) of NMC directed all medical colleges to fill their details on NMC portal.

At that time, medical colleges/institutes were notified that the requisite fee of ₹ 3,54,000(including 18% GST) must be paid online through the portal’s payment gateway along with the application for permission of admission of seats for UG courses for the academic year 2024-25, irrespective of prior payments.

Now, the NMC has told the medical colleges that have already made the payment to not pay the requisite fee again but they need to submit the details of the payment made with the NMC. The recent notice read:

“All Medical Colleges/Institutes are hereby informed that in case such Medical Colleges/Institutes have already paid the requisite fee for Renewal/Recognition/ Continuation of Recognition for the year 2024-25 need not to pay the fee again. Details of the payment made are required to be filled in the requisite column in payment gateway of the portal along with the supporting documents”

Medical Dialogues had earlier reported that in the previous notice, the NMC further warned that no seat will be permitted if any medical college fails to submit the annual declaration within the deadline.

“All Medical Colleges/Institutes having valid Letter of Permission (LoP) for MBBS admission are hereby directed to fill the details/data of respective Institutions on NMC portal for annual declaration as required in the NMC Act, 2019 and various regulations issued by NMC from time to time. Submission of duly completed Annual Declaration Form of each College on NMC Portal is mandatory for annual renewal of permission of UG-MBBS seats. No seat shall be permitted in case the College/Institution fails to submit the Annual Declaration within the specified time period,” stated the NMC.

The Commission had said that all the medical colleges must make the payment online irrespective of whether the payment has been made earlier or not. It also mentioned that no mode of payment other than payment gateway shall be acceptable. “Payment, if any, made earlier on account of Renewal/Recognition/Continuation of Recognition shall be refunded by the Accounts Division of NMC separately,” NMC clarified in its notice.

To view the official Notice, Click here : https://medicaldialogues.in/pdf_upload/public-notice-24-234890.pdf

PM Modi inaugurates Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital

New Delhi: Prime Minister Narendra Modi inaugurated the state-of-the-art hospital, Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital built with Indian assistance showcasing the robust development cooperation between India and Bhutan.

The Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital is a state-of-the-art 150-bedded facility that has been built with the assistance of the Government of India in Thimphu.

“A boost to partnership in healthcare. PM @narendramodi together with PM @tsheringtobgay of Bhutan inaugurated the Gyaltsuen Jetsun Pema Mother and Child Hospital in Thimphu. The state-of-the-art hospital is a shining example of India-Bhutan development cooperation,” External Affairs Ministry Spokesperson Randhir Jaiswal said in a post on X.

Also Read:PM Modi inaugurates 960-bed AIIMS Kalyani, IPD services open for patients

India’s support for the hospital’s development spanned two phases, with the first phase operational since 2019, constructed at a cost of Rs 22 crore. The second phase, initiated in 2019 as part of the 12th Five Year Plan and completed recently at a cost of Rs 119 crore, further enhances the hospital’s capabilities.

The new facility promises to elevate the quality of mother and child health services in Bhutan, boasting state-of-the-art departments for Pediatrics, Gynecology and Obstetrics, Anesthesiology, Operation Theatre, Neonatal Intensive Care, and Pediatric Intensive Care.

According to PTI, “The Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital stands as a shining example of India-Bhutan partnership in health care,” it added.

“Bhutan has been receiving a lot of support from India, especially in the health sector, starting from the three referral hospitals and also other health facilities,” Bhutan Health Minister Tandin Wangchuk told PTI Videos.

“It is an honour for us to have Shri Narendra Modi here, inaugurating the Gyaltsuen Jetsun Pema Mother and Child Hospital,” he said, adding that this hospital is purely dedicated to the mothers and the children of Bhutan.

He added that there is a proposal for a cancer hospital which will come up on this campus only. “We are referring all the cancer patients to India. So after the completion of the cancer hospital, I think this will also enhance the tertiary care of health services in Bhutan,” he added.

According to PTI reports, Modi, who arrived in Bhutan on Friday for a two-day State visit to further cement India’s unique relations with the Himalayan nation, called on the King of Bhutan, Jigme Khesar Namgyel Wangchuck and held talks with Prime Minister Tobgay on Friday.

Modi also announced India’s commitment to provide Rs 10,000 crore in support to Bhutan over the next five years.

Bhutan’s King Wangchuck conferred the ‘Order of the Druk Glyalpo’ to Prime Minister Modi at a public ceremony here on Friday, making him the first foreign Head of the Government to receive the honour.

The award recognizes Modi’s efforts in bolstering India-Bhutan friendship and his people-centric leadership.

“It is with great humility that I accept the Order of the Druk Gyalpo. I am grateful to HM the King of Bhutan for presenting the Award. I dedicate it to the 140 crore people of India. I am also confident that India-Bhutan relations will keep growing and benefit our citizens,” Modi wrote in a post on X on Friday night.

India and Bhutan established diplomatic relations in 1968.

The basic framework of India- Bhutan relations has been the Treaty of Friendship and Cooperation signed in 1949 between the two countries, which was revised in February 2007.

Also Read:PM Modi inaugurates 300-bed PGI satellite centre in Sangrur