Johnson and Johnson Gets CDSCO Panel Nod For Additional Indication of Daratumumab to Treat Light chain AL amyloidosis

New Delhi: Granting local clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Johnson and Johnson’s anticancer drug Daratumumab solution for Injection 1800 mg (120 mg/ml) for an additional indication for the treatment of Light chain (AL) amyloidosis in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis.

This came after Johnson and Johnson presented the proposal for approval of additional indication i.e, for the treatment of Light chain (AL) amyloidosis in combination with cyclophosphamide, bortezomib, and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis along with a request for local clinical trial waiver.
The committee noted that the treatment of Light chain (AL) amyloidosis comes under the orphan drug category, and the applied indication is approved in the US, EU, Canada, Brazil, Switzerland, the U.K., and China.

Amyloidosis is a disorder of protein misfolding and metabolism in which insoluble fibrils are deposited in various tissues, causing organ dysfunction and eventually death.

Primary or light chain (AL) amyloidosis, the most common type of systemic amyloidosis, occurs when the free light chains normally associated with immunoglobulins are produced in excess by clonal or frankly malignant plasma cells. Although AL amyloidosis is not considered a cancer, it shares some similar characteristics and treatments with multiple myeloma.

Daratumumab is a CD38-directed cytolytic antibody used alone or as an adjunct drug in the treatment of multiple myeloma and light chain amyloidosis. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found in some types of immune cells and tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells.

Daratumumab binds to CD38, causing cells to apoptosis via antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, inhibition of mitochondrial transfer, or antibody-dependent cellular phagocytosis.

At the recent SEC meeting held for Oncology on 15th May 2024, the expert panel reviewed the proposal presented by Johnson and Johnson for approval of additional indication of Daratumumab solution for Injection 1800 mg (120 mg/ml) for the treatment of Light chain (AL) amyloidosis in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis along with a request for local clinical trial waiver.

The committee observed that the treatment of Light chain (AL) amyloidosis comes under the orphan drug category. Furthermore, the expert panel highlighted that the applied indication for the treatment of Light Chain (AL) Amyloidosis is approved in the US, EU, Canada, Brazil, Switzerland, the UK, and China.

After detailed deliberation, the committee recommended approval of the proposed additional indication with a waiver of a local clinical trial with the condition to conduct the Phase IV clinical trial.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months for SEC deliberation.

Also Read:Discontinue Olaparib Tablets Marketing For Specific Cancers: CDSCO

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Even home-made foods can be unhealthy: ICMR

Home-cooked meals, often considered healthier, can still be unhealthy if they contain too much fat, sugar, or salt. According to the Indian Council of Medical Research (ICMR), even homemade foods can become unhealthy when prepared with high amounts of these ingredients. High-fat foods are energy-dense, meaning they have high calories but lack essential nutrients like vitamins, minerals, and fiber. Regular consumption of such foods can lead to overweight and obesity, depriving the body of necessary nutrients.
High sugar content in foods, including store-bought items like juices and cereals, can contribute to obesity, type 2 diabetes, oral defects, and abnormal blood sugar levels. Excessive sugar intake is a major factor in significant weight gain and related health issues. Indian food is also known for its high salt usage, which can increase sodium intake. Long-term consumption of a high-salt diet can raise blood pressure, leading to heart attacks, strokes, and kidney failure, especially in individuals with hypertension.

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International organ trafficking racket: 2 accused held

In an investigation into an international organ trafficking racket, the Ernakulam Rural Police Special Investigation Team (SIT) apprehended one more accused in connection with the case after the arrest of a Thrissur native.
While the police have managed to capture only minor role players in the case, the main suspects remain at large. An investigation is ongoing to locate their whereabouts.
For more information click on the link below:

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NMC imposes Rs 1 crore fine on Lakhimpur Medical College and Hospital

Taking cognisance of the severe mismanagement at Lakhimpur Medical College and Hospital, the National Medical Commission (NMC) has imposed a hefty fine of Rs 1 crore on the institute.
NMC, the Apex Medical Education Regulatory Body in India announced its decision in a letter directed to the medical college principal. The Commission also warned the institute to take further action if the college failed to settle its pending dues and debts immediately.
For more information click on the link below:

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Health Bulletin 25/ May/ 2024

Here are the top health stories for the day:

NMC slaps Rs 1 crore fine on Lakhimpur Medical College Hospital
Taking cognisance of the severe mismanagement at Lakhimpur Medical College and Hospital, the National Medical Commission (NMC) has imposed a hefty fine of Rs 1 crore on the institute.
NMC, the Apex Medical Education Regulatory Body in India announced its decision in a letter directed to the medical college principal. The Commission also warned the institute to take further action if the college failed to settle its pending dues and debts immediately.
For more information click on the link below:
International organ trafficking racket: 2 accused arrested, NIA to take over probe
In an investigation into an international organ trafficking racket, the Ernakulam Rural Police Special Investigation Team (SIT) apprehended one more accused in connection with the case after the arrest of a Thrissur native.
While the police have managed to capture only minor role players in the case, the main suspects remain at large. An investigation is ongoing to locate their whereabouts.
For more information click on the link below:
HPV vaccines prevent cancer in men as well as women, new Research suggests
New research highlights the significant impact of the HPV vaccine in preventing cancer in both men and women, although fewer boys than girls are getting vaccinated in the United States. Originally developed to prevent cervical cancer in women, the HPV vaccine is now showing promising results in reducing HPV-related cancers in men.
The study compared 3.4 million vaccinated and unvaccinated individuals and found that vaccinated men had a lower risk of developing cancers of the anus, penis, mouth, and throat. Specifically, there were 57 HPV-related cancers among unvaccinated men compared to 26 in vaccinated men.

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Forced to write prescriptions 700 times, Denied food for up to 7 days: 4 Doctors at Ahmedabad’s Medical College Suspended for allegedly Ragging Juniors

Ahmedabad: Taking cognisance of the ragging activities directed at junior doctors, four senior doctors of Ahmedabad Municipal Corporation Medical Education Trust (AMC MET)-affiliated Narendra Modi Medical College in Maninagar have been suspended for their role in this matter.

According to the FPJ report, the junior doctors involved in this connection suffered mental agony during these horrific episodes of ragging. They were reportedly forced to write prescriptions 700 times and were denied food for up to seven days. 

The action against the senior doctors comes after a complaint was filed with the Medical College Council. After examining these complaints in detail, the Council issued the suspension order to the senior doctors. 

Those facing the suspension order includes two male and two female doctors. They were found guilty of ragging the junior doctors on the medical college property, reports FPJ.

Also Read: NMC National Task Force to Hold Meeting to Discuss Mental Health and Well-being of Medical Students

As per the latest media report by the Free Press Journal, a formal complaint was lodged on May 16 with Dr. Patel, the Head of the Department. After receiving the complaint, Dr. Patel stepped in trying to settle the issue internally by calling a meeting between the senior and junior doctors. However, three days later, the junior doctors took the matter to the Dean of the Medical College, Dr. Shah. The juniors approached the Dean as the ragging episodes allegedly continued despite promises of ending such behaviour.

Consequently, Dr. Shah requested a meeting of the Medical College Council to discuss the matter. During the meeting, the allegations including the degree of ragging methods were discussed. Following this, the concerned four senior doctors were suspended.

FPJ has reported that the senior doctors used techniques of punishing the junior doctors that involved psychological and physical abuse. For instance, the junior doctors were made to write hundreds of prescriptions and they were told to fast for long stretches of time. 

One of the doctors, Dr. Vaghani has been suspended for two years, a female doctor Dr. Patel has been suspended for one year. The other two doctors- Dr. Pareija and Dr. Nayak have been suspended for 25 days, Desh Gujarat has reported.

Also Read: 108 Ragging Complaints in last 2 years, Odisha Medical Colleges Fail to Publicise Anti-Ragging Committees despite NMC norms

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Medical Bulletin 25/ May/ 2024

Here are the top medical news for the day:

Study Links Microplastics in Blood Clots to Elevated Cardiovascular Risks
In a recent study published in the journal EBioMedicine, researchers explored how microplastic affects human health. They examined blood clots taken from deep veins, as well as from arteries in the heart and brain. The study focused on measuring the amount, physical characteristics, and types of microplastics present in these blood clots.
Microplastics, tiny pieces of plastic less than 5 millimetres in size, are a growing concern for human health. When we consume food or water contaminated with microplastics, these particles can enter our bodies and accumulate in various organs and tissues. Research suggests that microplastics may have harmful effects on human health, including inflammation, oxidative stress, and disruption of hormonal balance.
In humans, microplastics have been detected in blood, sputum, liver, heart, lungs, testes, endometrium, placenta, and amniotic fluid. Studies have even found microplastics in blood clots. Since the formation of blood clots is influenced by both genetic and environmental factors, these findings indicate that microplastics could significantly threaten vascular health.
In this study, researchers used various methods to examine and measure the kinds of materials, amounts, and physical characteristics of microplastics found in blood clots from three significant blood vessels: deep veins, coronary arteries, and intracranial arteries.
The participants included individuals who needed surgery to remove blood clots after experiencing heart attacks, strokes, or deep vein thrombosis. They then analysed the blood clot samples for microplastics, focusing on ten different types of polymers and used microscopy and spectroscopy to study the size, quantity, and shape of the particles.
The results showed that microplastics, made from different materials and with various physical traits, were present in different amounts in blood clots that formed in major arteries and veins. These microplastic levels were higher in patients who had severe ischemic strokes.
Out of 30 blood clots from patients with heart attacks, deep vein clots, or ischemic strokes, 24 (80%) contained microplastics. The average concentration of microplastics in the clots was 141.80 μg/g for heart attack cases, 69.62 μg/g for deep vein thrombosis cases, and 61.75 μg/g for ischemic stroke cases.
The findings revealed that blood clots taken from major blood vessels of patients with heart attacks, ischemic strokes, or deep vein thrombosis contained notable amounts of microplastics with different polymer types and characteristics. Additionally, it was found that higher levels of microplastics correlated with an increased risk of thrombotic events and more severe disease outcomes.
Reference: Wang, T., Yi, Z., Liu, X., Cai, Y., Huang, X., Fang, J., Shen, R., Lu, W., Xiao, Y., Zhuang, W., & Guo, S. (2024). Multimodal detection and analysis of microplastics in human thrombi from multiple anatomically distinct sites. EBioMedicine, DOI: 10.1016/j.ebiom.2024.105118
Flavonoid-Rich Diet Reduces Type 2 Diabetes Risk by Nearly 28%, Reveals New Study
A study published in the journal Nutrition & Diabetes revealed that increasing the intake of flavonoid-rich foods can reduce the risk of developing type 2 diabetes.
Type 2 diabetes poses a growing public health challenge due to its rising prevalence worldwide. Presently, over 415 million individuals are affected by diabetes, with more than 4 million deaths attributed to the condition globally.
Eating more plant-based foods can lower the chances of getting type 2 diabetes. Plants have many natural compounds called flavonoids, which are good for health. These flavonoids come in different types, like flavanones, flavones, and others.
Studies have shown that eating more foods with flavonoids can make the body more sensitive to insulin, lower resistance to insulin, and improve the levels of fats in the blood.
In this study, scientists have investigated the association between a flavonoid-rich diet and incident type 2 diabetes. They studied 113,097 people who were part of the UK Biobank. The researchers checked the participants’ diets by asking them what they ate for two or more days and used a database to see how much flavonoid they were consuming. They focused on ten foods that are high in flavonoids and calculated a score based on how often people ate these foods.
The results showed that on average, people in the study consumed about 805.7 milligrams of flavonoids each day. Over the course of 12 years, researchers found 2,628 new cases of type 2 diabetes.
Women, older adults, those who were physically active tended to eat more foods rich in flavonoids. After considering factors like age and lifestyle, researchers discovered that those who ate six servings of flavonoid-rich foods daily had a 28% lower risk of developing type 2 diabetes compared to those who ate just one serving per day.
For every additional serving of flavonoid-rich foods consumed per day, the risk of developing diabetes decreased by 6%. Specifically, higher intakes of black or green tea, berries, and apples were linked to a 21%, 15%, and 12% lower risk of developing type 2 diabetes, respectively.
The findings revealed that flavonoid-rich foods can significantly reduce the risk of type 2 diabetes by regulating obesity, glucose metabolism, inflammation, kidney function, and liver function.
Reference: Thompson AS. 2024. Higher habitual intakes of flavonoids and flavonoid-rich foods are associated with a lower incidence of type 2 diabetes in the UK Biobank cohort. Nutrition & Diabetes. DOI: 10.1038/s41387-024-00288-
Effect of Prenatal DHA Supplementation on Infant Fat Mass: Study
In a recent study published in the journal Current Developments in Nutrition, researchers investigated the associations between mother-consumed docosahexaenoic acid (DHA) supplements and offspring obesity outcomes.
Childhood obesity is a serious health issue where kids weigh much more than they should for their age (BMI > 95th percentile). It’s becoming more common.
Studies have shown that the first 1,000 days after birth are crucial because babies’ fat cells grow quickly during this time, affecting their weight later on. Some research suggests that taking certain supplements during pregnancy can help prevent childhood obesity.
One area scientist are looking into is polyunsaturated fatty acids (PUFAs), like docosahexaenoic acid (DHA). When pregnant moms take DHA, it might reduce their babies’ fat mass by stopping certain cells from becoming fat cells.
In this study, scientists conducted a randomized, controlled, double-blinded study to investigate if giving pregnant women extra DHA supplements could lower the chances of their babies gaining too much fat because of increased weight gain during pregnancy.
They explored if taking different amounts of DHA during pregnancy (1000 mg/day versus 200 mg/day) would change the weight gain during pregnancy and affect the amount of fat in the babies at 24 months old. They also looked at whether these effects were different for boys and girls. They measured the weight and height of the mothers at the start of the study, and regularly took blood samples to check the levels of different fatty acids.
Out of the 250 pregnant women in the study, 124 were given a low dose of DHA supplements (200 mg/day), while the rest received a higher dose (1000 mg/day). Nearly all of the participants (90.9%) followed their treatment plans well.
The results showed that babies born to mothers who received the high dose of DHA had more total fat mass compared to those whose mothers received the low dose. Moreover, babies in the high-dose group had notably more fat around their central areas, while other fat measurements remained similar between the two groups.
The findings stayed the same throughout the entire 24-month study, supporting previous research that prenatal supplements can help with baby health. However, more research is needed to confirm how these results might affect children.
Reference: Hull, H. R., Brown, A., Gajewski, B., Sullivan, D. K., & Carlson, S. E. (2024). The effect of prenatal DHA supplementation on offspring fat mass and distribution at 24 months old. In Current Developments in Nutrition (p. 103771). Elsevier BV, DOI – 10.1016/j.cdnut.2024.103771,

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Retired GMC Principal Dr Sheetal Singh passes away at 80

Srinagar: In an unfortunate incident, Prof Dr Sheetal Singh, a prominent Laparoscopic Surgeon and former Principal and Dean of Government Medical College (GMC) Srinagar passed away at the age of 80 on Wednesday at his Trikuta Nagar residence.    

Dr Sheetal who previously held the position of HOD of Surgery at GMC Jammu suffered a cardiac arrest leading to his untimely demise. He is survived by his wife Dr Supinder Kour and two daughters, both doctors.   

Also read- Former Novartis India Chief Ranjit Shahani No More

After he retired from both medical colleges, Dr Sheetal continued providing services to the patients by treating them and conducting surgeries at Lochan Nursing Home, Daily Excelsior reports.   

To mourn his sad demise, a condolence meeting was held on May 24 at Govt Medical College Srinagar. It was attended by Principal /Dean Govt Medical College Srinagar Prof Dr Iffat Hassan, Administrator Associated Hospitals Mr Mohamad Ashraf Hakak Ex-HODs Prof Dr Muneer Khan, Prof Dr Fareeda Ashai, Prof Dr T.S.Sethi, Prof Dr Shafeeqa Aslam, present HODs and Faculty members, Prof Dr Sajad Nazir, Prof Dr Iqbal Saleem, Prof Dr Manzoor Ahmad Latoo, Prof Dr Hina, Prof Dr Ghulam Mohammad, Prof Dr Sameena Farhath, Prof Dr MR Attri, DrSajjad, Medical Superintendent Govt. Lal Ded Hospital and staff of the GMC and Associated Hospitals, officials told Sachnews in a press statement.  

On this occasion, a two-minute silence was observed in the memory of the Late Prof Dr Sheetal Singh. The speakers on the occasion remembered the services of Dr Sheetal Singh as a Surgeon and as Principal/Dean of GMC Srinagar.   

Prof Dr Iffat Principal / Dean GMC Srinagar while paying homage to Dr Sheetal Singh praised him for his professionalism and services towards Patient care and Medical Education. She prayed that the departed soul should rest in peace and showed her sympathies with the family of Prof Dr Sheetal Singh in this hour of grief.

Dr Muneer Khan Ex-HOD Surgery while paying his condolences remembered the dedication and devotion of Prof Sheetal Singh in his professional services.

Prof Dr Iqbal Saleem HOD Surgery reminisced about the experience of Dr Sheetal Singh in dealing with newcomers in the profession and how he would handhold them and guide them in learning all surgical skills.

Also read- Renowned Genetic Medicine Specialist, Padma Shri Awardee Dr IC Verma No More

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Bharat Biotech Co-founder Dr Krishna Ella receives award from Johns Hopkins Bloomberg School of Public Health

Hyderabad: Dr Krishna Ella, the Co-founder and Executive Chairman of Bharat Biotech, has received the esteemed Dean’s Medal from the Johns Hopkins Bloomberg School of Public Health.

The award was presented to Dr. Ella by Dean Ellen J. MacKenzie during Bloomberg School’s Convocation Ceremony at Baltimore, Maryland, for his exceptional leadership, enduring vision and contribution to improving public health.

John Hopkins Bloomberg School of Public Health acknowledges Dr. Ella’s pioneering work, remarkable influence, and determination to develop an indigenous, innovative, and safe vaccine focused on global public health, according to a statement by Hyderabad-based Bharat Biotech on Friday.

Also Read:1 in 3 Bharat Biotech Covaxin takers reported adverse events, finds BHU study

This is the school’s highest honour, reserved for outstanding public health researchers and practitioners who demonstrate exceptional leadership in safeguarding and improving public health.

“I acknowledge this medal as a global recognition of India’s scientific excellence, and dedicate this medal to Bharat, which has shown remarkable success by advancing science and R&D, to our exemplary team of scientists, and the results of our strong commitment to the public,” said Krishna Ella on receiving the Dean’s Medal.

His contributions to shaping India’s policies on science, research and innovation made possible the development of vaccines and monoclonal antibodies, including Covaxin, India’s own Covid-19 vaccine.

Under his guidance, Bharat Biotech manufactured the first indigenous rotavirus vaccine (Rotavac), the first WHO-prequalified Typhoid conjugate vaccine (Tybar TCV) and Japanese Encephalitis Vaccine, JENVAC.

Also Read:ICMR distances itself from BHU Covaxin study, calls it poorly designed

During the COVID-19 pandemic, Bharat Biotech developed COVAXIN in a record time, conducting the largest-ever human clinical trials and peer-reviewed by world-leading medical journals.

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Healthcare most violative sector in advertising: ASCI Annual Report

New Delhi: The healthcare sector has emerged as the top violator in
the realm of digital media advertising as the sector accounts for 19%
of all ads processed, making it the most violative sector for the year. Out of a total of 8,062 ads that
required modifications, 1569 were from the healthcare sector. 

This came after the Advertising Standards Council of India (ASCI) published its annual analysis
report. This sector has consistently been a concern for ASCI due to the
prevalence of misleading advertisements that exploit consumer trust and
vulnerability. 

Advertising of certain products is banned under various
laws, for example, drugs that claim to be magic remedies or cures for certain health conditions. However, there has
been a blatant disregard for rules in this sector. The second biggest category
of ads reported for direct violation of the law was the Drugs and Magic Remedies
sector. Out of 1,249 ads from 239 advertisers reported to the Ministry of
AYUSH, 91% violated clause 3(b) of the DMR Act, which prohibits ads that claim
to enhance sexual prowess or treat specified diseases and disorders.  

The report mentioned, “In an era where healthcare
choices are abundant and information is readily accessible, it is crucial to
acknowledge the potential harm caused by misleading ads that abuse the trust of
consumers and take advantage of their vulnerability. ASCI looked at a total of
1575 ads out of which 99% required modification.”

Of these, 1,249 ads were processed for
violating the Drugs and Magic Remedies Act (DMR Act). Of the remaining 326
ads, 190 were from clinics, hospitals, and wellness centers making exaggerated
claims about their services and treatments for chronic conditions.
Additionally, 129 ads from pharmaceutical companies made unverified claims
about prevention, cure, superior quality, and leadership, while 7 ads were
related to medical supplies and health apps.

The DMR Act prohibits the advertisement of certain drugs
for the treatment of certain diseases and disorders. Ads that featuring drugs
that suggest or are intended to encourage the use of drugs for maintenance or
enhancement of a person’s ability for sexual pleasure, or for the treatment of
illnesses and ailments (under whatever name they may be called) claiming to
prevent or cure 56 diseases as mentioned in the list are prevented under the
Act.

“Despite the presence of the DMR Act,
there continues to be a proliferation of advertisers promoting
medicines/ayurvedic products, claiming the cure and treatment of these
ailments. These advertisements misuse the trust of vulnerable consumers and
could be detrimental to their health,” mentioned the report.

The report further stated that 91% of ads violated the Celebrity Guidelines
and among those, healthcare contributes 9% of the total. As far as BabyCare products
are concerned, misleading ads could harm the parents’ trust and the baby’s health. For the first time, Babycare has
made it to the top 10 violators list owing to influencers promoting products and services
without disclosing material connections.
81% of the 91 ads processed were from influencer promotions without a disclosure. 99% of these ads required modification
and 76 % were not contested by the advertisers.

The ASCI report highlights the ongoing challenge of
regulating misleading healthcare advertisements and the need for stricter
enforcement to protect consumers from deceptive claims. 

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