Antibodies in breast milk provide protection against common GI virus, unravels research

A study led by researchers at the University of Rochester Medical Center found that breast milk provides protection against rotavirus, a common gastrointestinal disease that causes diarrhea, vomiting and fever in infants. Babies whose mothers had high levels of specific antibodies in their breast milk were able to fend off the infection for a longer period than infants whose mothers had lower levels. The findings are expected to drive future research to improve infant health through optimized breastfeeding practices.

Published in the Journal of Clinical Investigation and funded by the Bill and Melinda Gates Foundation, the study also found significant differences in antibody profiles in breast milk between mothers in high-income countries (HICs) and low- and middle-income countries (LMICs). Researchers analyzed human milk samples from 695 women in Finland, the U.S., Pakistan, Peru, and Bangladesh, and measured specific IgA and IgG antibodies, which are common antibodies produced in breast milk, against 1,607 proteins from 30 pathogens.

The research,led by Dr. Kirsi Jarvinen-Seppo, MD, PhD, professor in the Division of Allergy and Immunology at UR Medicine Golisano Children’s Hospital (GCH), tracked antibody levels and kinetics over time to analyze antibody responses to a wide range of respiratory, diarrheal and sepsis pathogens in human milk. The study’s primary aim was to understand the protective properties of these antibodies and how they vary across different geographic and economic regions.

“We would expect to find differences in antibody levels in different countries, due to different diseases circulating among areas of the world, but this is one of the first times that there’s been a head-to-head comparison for dozens of pathogens across several continents,” said Jarvinen-Seppo. “It was encouraging to see such a clear link between higher antibody levels and a delay to rotavirus infection, and this was consistently observed among an independent validation cohort.”

Other notable findings from the study:

  • Milk from women in LMICs had higher levels of IgA and IgG antibodies against various intestinal and respiratory pathogens compared to milk from HICs. This difference was particularly notable for pathogens such as Shigella and pneumococcus, which are major contributors to morbidity and mortality in young children.
  • Higher body mass index (BMI) was associated with lower antibody levels, which went against expectations.

“The variation in antibody profiles between regions highlights the impact of economic and environmental factors on maternal immunity,” said Jarvinen-Seppo.

In addition to Rotavirus findings, the discovery that a higher BMI was associated with lower antibody counts in breast milk was also unexpected.

“We had anticipated that underweight mothers might have lower antibody levels due to poorer nutritional status,” said Jarvinen-Seppo. “Due to rising obesity rates worldwide, this could be a significant finding, but this is preliminary and additional research is needed since this is the first time this has been measured.”

“While the data on rotavirus protection is compelling, the geographical and BMI-related variations highlight areas where further research is essential. The study sets the stage for additional investigations that could lead to better understanding and interventions for improving infant health globally,” said Jarvinen-Seppo.

Reference:

Dr. Kirsi Jarvinen-Seppo, Human milk antibodies to global pathogens reveal geographic and interindividual variations in IgA and IgG, Journal of Clinical Investigation, https://doi.org/10.1172/JCI168789.

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Stroke rates increasing in individuals living with SCD despite treatment guidelines, reveals study

The incidence of stroke continues to increase for adults and children living with sickle cell disease (SCD) despite the Stroke Prevention Trial in Sickle Cell Anemia (STOP) establishing standards of care like transfusions and tests to measure blood flow in the brain for those deemed high-risk, according to a study published today in Blood.

Individuals living with SCD, the most common inherited red blood cell disorder in the United States, are especially susceptible to cerebrovascular events (CVEs). This includes ischemic or hemorrhagic strokes, when a blood vessel leading to the brain is either blocked by a blood clot or bursts, and transient ischemic attacks (TIAs), when a blood clot temporarily blocks a blood vessel leading to the brain but does not cause long-term damage.

STOP, a landmark clinical trial published in 1998, demonstrated that chronic red blood cell transfusions effectively decreased the incidence of cerebrovascular events (CVEs) – such as strokes – in high-risk children with SCD identified by abnormal blood flow as measured by a Transcranial Doppler (TCD) testing, a type of brain ultrasound.

In a real-world, population-based study, Dr. Wun and his team found that the risk of stroke increased with age, doubling for every 20 years of age.

“As hematologists, our training emphasizes that the risk of stroke is highest in young children, but I think that has resulted in far less attention being paid to adult patients,” said Ted Wun, MD, associate dean for clinical and translational research at the University of California Davis School of Medicine and study senior author. “There’s very little data on [stroke in adults living with SCD], so we just extrapolate what happens in children to adults, but we don’t know if that’s appropriate or not – if the TCD value cutoffs in children can apply to adults, if TCD works in adult patients and we just don’t do it.”

The researchers used data from California’s Emergency Department Utilization (2005 – 2019) and Patient Discharge Data hospitalization (1991 – 2019) databases to identify 7,636 patients with a diagnosis of SCD. Of these patients, 733 (9.6%) had experienced at least one CVE, defined as an ischemic stroke, hemorrhagic stroke, or TIA, with prevalences of 451 (5.9%), 227 (3%), and 205 (2.7%), respectively. CVEs were more common in women and patients hospitalized three or more times per year.

The cumulative incidence of hemorrhagic stroke increased 13-fold from age 20 to age 60. Additionally, despite a two-year decline in CVEs following the publication of the STOP study, the highest rates of all CVEs occurred across all age groups in the most recent decade, 2010 – 2019.

“Even in children, who probably get the best care for patients with SCD in this country, these trends are opposite what we would hope,” said Dr. Wun. “Based on these results, it appears that STOP guidelines haven’t been effectively implemented.”

Dr. Wun and his team hypothesized that the increase in strokes post-STOP could be due to decreasing adherence to the TCD screening guidelines, improved technology to diagnose ischemic strokes, low rates of blood transfusion therapy, or low usage of hydroxyurea, a drug commonly used to decrease the likelihood of blood cells developing a sickle shape. The researchers also looked at modifiable risk factors for stroke and found that factors increasing risk of ischemic stroke included frequent hospitalization, high blood pressure, high cholesterol, and a prior TIA. However, patients exhibiting risk factors such as acute chest syndrome, liver failure, and prior ischemic stroke were more likely to suffer a hemorrhagic stroke.

These updated data on modifiable risk factors of stroke “emphasize the need to pay attention to screenings for high cholesterol, high blood pressure, and other risk factors in adults,” said Olubusola Oluwole, MD, assistant professor at the University of Pittsburgh and study first author.

“The preventive steps that we know help prevent stroke in the general population are just as important for people living with SCD,” added Dr. Wun, especially as people with SCD live longer and their risk of stroke increases.

The study had several limitations, including a lack of reliable data on tobacco use, which increases the risk of stroke, and SCD genotype. Additionally, the authors did not have access to imaging reports and could not radiographically confirm a stroke diagnosis. Furthermore, the rate of CVEs in patients in California may be underestimated if patients had a stroke outside of the state, died of stroke prior to hospitalization, or if TIA symptoms were managed at home.

The researchers hope this study will stimulate more interventional and prospective studies on stroke and SCD in adults.

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Study compares Pregnancy outcomes of fresh with cryopreserved-thawed embryo transfer

The use of cryopreserved donor oocytes in the United States
has been steadily increasing. One question that remains unanswered about
cryopreserved donor oocytes is whether there is a difference in pregnancy
outcomes among patients who use a fresh embryo transfer (ET) compared with
patients who cryopreserve the resulting embryo, followed later by a frozen ET.
Given the widespread use of frozen donor oocytes, determining whether an
association exists between either fresh or cryopreserved-thawed ET and the
resulting pregnancy outcome is imperative. Therefore, this study by Lauren
Barrison et al evaluated pregnancy outcomes among frozen donor oocyte cycles,
comparing fresh ET with cryopreserved-thawed ET.

This retrospective cohort study examined donor oocyte thaw
cycles using cryopreserved oocytes from Donor Egg Bank USA between 2016 and
2021. The study received institutional review board approval. Donor Egg Bank’s
standardized protocols were followed for donor screening, donor stimulation,
oocyte retrieval, oocyte vitrification, and oocyte shipping. Authors included
donor cycles with oocyte lots that were received by 2 different recipients,
with one undergoing fresh blastocyst transfer and one undergoing
cryopreservedthawed blastocyst transfer. The primary outcome was an ongoing
pregnancy, defined as a viable intrauterine pregnancy at the time of referral
to an obstetrician at approximately 8 weeks of gestation. Secondary outcomes
included additional pregnancy and embryonic development outcomes

A total of 1,210 recipient cycles of cryopreserved donor
oocytes were included (605 underwent fresh ET, 605 underwent
cryopreserved-thawed ET). The distribution for the year of oocyte thawing
between the fresh and frozen ET groups was distributed similarly for both
groups. The 2 groups were identical in regard to donor characteristics given
the sibling oocyte study design (mean age 25.5 years, mean body mass index 23.0
kg/m2 , mean antimullerian hormone level 5.9 ng/mL, mean antral follicle count
28.3). The recipients in the 2 groups were similar in age (mean age: 42.2 vs.
42.0 years). Surgically retrieved sperm was used by 2.8% of the fresh ET group
and 1.3% of the cryopreserved-thawed ET group.

There was no statistically significant difference in the
ongoing pregnancy rate between the fresh vs. cryopreserved-thawed ET groups
(51.2% vs. 49.6%; relative risk 0.97 [95% confidence interval, 0.83–1.14]).
Secondary pregnancy outcomes were also similar between the 2 groups.

Prior studies with mixed findings focused on comparing the
use of fresh vs. cryopreserved donor oocytes in fresh ET cycles or comparing
fresh vs. cryopreserved-thawed ET using fresh donor oocytes. Many patients use
cryopreserved donor oocytes because of their greater availability and access,
shorter time to treatment, and greater ease of cycle synchronization.

This study specifically addressed cryopreserved donor
oocytes and the potential impact of a second ‘‘freeze-thaw’’ on these gametes.

The retrospective study design restricts analysis to data
previously collected; the Donor Egg Bank’s data set did not include additional
recipient demographic information or transfer cycle characteristics, which
limits the ability to account for these potential confounders and the
generalizability of the findings. In conclusion, among patients using frozen
donor oocytes, pregnancy outcomes per donor oocyte thaw cycle were comparable
between recipients undergoing fresh ET compared with recipients using sibling
oocytes undergoing cryopreserved-thawed ET. On the basis of these findings,
patients using cryopreserved donor oocytes should not be deterred from subsequent
embryo cryopreservation.

Source: Lauren Barrison, M.D.a Melissa Stratton, B.A.b Wayne
Caswell, M.S; VOL. 122 NO. 3 /FertilitySterilty

https://doi.org/10.1016/j.fertnstert.2024.04.027

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Retinitis pigmentosa patients may experience new depressive episodes, finds JAMA study

A new large-scale study published in the Journal of American Medical Association highlighted the increased risk of depressive disorder among patients diagnosed with retinitis pigmentosa (RP) that causes progressive vision loss. This population-based cohort study revealed that individuals with RP face a significantly higher likelihood of developing depressive symptoms when compared to the general population. 

The research analyzed data from the Health Insurance Review and Assessment Service in Korea between 2008 and 2022 and involved 10,879 individuals newly diagnosed with RP from 2011 to 2021. The objective of this research was to examine the link between RP and depressive disorder, particularly in the context of different age groups and sexes.

The study found that the 10-year cumulative incidence rate of depressive disorder in RP patients, which stood at 17.67%. The study also reported that older patients and women with RP were at even higher risk of developing depression. Also, women had a 46% greater risk of depression when compared to men. Additionally, the individuals aged 40 and older were nearly twice as likely to develop depression than the younger RP patients.

The patients were categorized into 3 groups based on their age at diagnosis as under 20 years old, between 20 and 39 years old and 40 years or older. The study then calculated age- and sex-adjusted standardized incidence ratios (SIRs) of depressive disorder by revealing that RP patients had an overall SIR of 1.19 which indicated a 19% higher risk of depression than the general population. This increased risk was present in both men and women, though it was slightly higher in female patients. Age-based analysis showed a trend where the risk of depression was 50% higher than in the general population. The patients aged 60 and older also showed an elevated SIR of 1.25.

The results of this study indicated that individuals with RP who were older adults and women are particularly vulnerable to depression, likely due to the emotional and psychological toll of living with progressive vision loss. These findings highlight the critical need for emotional and mental health support for RP patients, alongside the management of their physical symptoms. Overall, the study emphasized the importance of early detection and treatment of depressive symptoms in RP patients to improve their overall quality of life.

Reference:

Kim, H. R., Lee, N. K., Suh, Y., Lee, C. S., Byeon, S. H., Kim, S. S., Lee, S. W., & Kim, Y. J. (2024). Incidence and Risk of Depressive Disorder in Patients With Retinitis Pigmentosa. In JAMA Ophthalmology. American Medical Association (AMA). https://doi.org/10.1001/jamaophthalmol.2024.3641

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Blastocyst telomere length predicts successful implantation after frozen-thawed embryo transfer: Study

Infertility affects millions of people of reproductive age
and has become the third most common disease globally. With help from in vitro
fertilization (IVF) technology, it is now estimated that more than 6 million
babies have been born through the IVF procedure. However, many factors,
including maternal dysfunction and embryonic chromosomal abnormalities, can
cause the failure of IVF treatment resulting in an overall live birth rate. Previously,
studies have reported that chromosome integrity (i.e. euploidy) is the primary
determinant of IVF success; thus, with the additional support of
preimplantation genetic testing for aneuploidy (PGT-A), the IVF success rates
have been improved in women with advanced maternal age and those who experience
recurrent miscarriage (RM). Nevertheless, the success rate only rises to 50%.
Thus, developing methods which will increase the implantation rate is the top
priority of the current move towards personalized maternal–fetal medicine in an
IVF center. Furthermore, the results also indicate that, in addition to
chromosomal integrity of the embryo, other factors related to embryo viability
may need to be considered to maximize the efficacy of IVF treatment.

Telomeres are stretches of DNA found at the ends of the
chromosomes. They cap and protect the end of a chromosome like the end of a
shoelace. Telomeres are crucial for the survival of all living cells and
telomere length (TL) is the key to controlling lifespan and aging of a cell.
Previous research hinted at the importance of TL in early human development,
suggesting that abnormal shortening may lead to embryo loss and implantation
failure. In this study, authors directly estimated TL in embryos using
sequencing data from preimplantation genetic testing. The study aimed to
determine if embryos with longer TL have a higher chance of successful
implantation after transfer.

The lifetime TL is established in the early cleavage cycles
following fertilization through a recombination-based lengthening mechanism and
starts erosion beyond the blastocyst stage. In addition, a telomerase-mediated
slow erosion of TL in human fetuses has been observed from a gestational age of
6–11 weeks. Finally, an abnormal shortening of telomeres is likely involved in
embryo loss during early development.

Blastocyst samples were obtained from patients who underwent
PGT-A and FET in an IVF center from March 2015 to May 2018. Digitally estimated
mitochondrial copy number (mtCN) and TL were used to study associations with
the implantation potential of each embryo. In total, 965 blastocysts from 232
cycles (164 patients) were available to investigate the biological and clinical
relevance of TL. A WGS-based workflow was applied to determine the ploidy of
each embryo. Data from low-pass WGS-PGT-A were used to estimate the mtCN and TL
for each embryo.

Of the 965 blastocysts originally available, only 216
underwent FET. While mtCN from the transferred embryos is significantly
associated with the ploidy call of each embryo, mtCN has no role in impacting
IVF outcomes after an embryo transfer in these women. The results indicate that
mtCN is a marker of embryo aneuploidy. On the other hand, digitally estimated
TL is the most prominent univariant factor and showed a significant positive
association with pregnancy outcomes (P < 0.01, odds ratio 79.1).

Study combined several maternal and embryo parameters to
study the joint effects on successful implantation. The machine learning
models, namely decision tree and random forest, were trained and yielded
classification accuracy of 0.82 and 0.91, respectively. Taken together, these
results support the vital role of TL in governing implantation potential,
perhaps through the ability to control embryo survival after transfer.

In this study, authors directly estimated TL in embryos
using sequencing data from preimplantation genetic testing. The study aimed to
determine if embryos with longer TL have a higher chance of successful implantation
after transfer. These findings highlight that blastocyst TL is a critical
factor influencing implantation potential, likely because of its role in
controlling embryo survival after transfer. In an attempt to reduce to time to
pregnancy in the in vitro fertilization (IVF) processes, authors studied
various maternal and embryo parameters, including TL, that have a high impact
on successful implantation into an artificial intelligence model suitable for
routine use in IVF clinics. Prioritizing embryos based on implantation
potential is vital in clinical infertility treatment, aiming to reduce twin
pregnancies and shorten waiting times during IVF. The predictive model
developed in this study offers a valuable tool to enhance clinical practice,
providing an optimized approach for individuals facing fertility challenges to
increase their chances of achieving parenthood.

Source: Chien et al.; Human Reproduction Open, 2024,
2024(2), hoae012

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COVID-19 linked to increased risk of acute kidney disorders, reveals new study

Researchers from West China Hospital, Sichuan University, have conducted a study revealing a significant association between COVID-19 and acute kidney disorders (AKD), including acute kidney injury (AKI), that varies over time. The study, led by Dr. Li Chunyang and Dr. Zeng Xiaoxi from the West China Biomedical Big Data Center, was recently published in the journal Health Data Science.

COVID-19, known for its impact on the respiratory system, also affects other organs, including the kidneys. The study aimed to investigate the time-dependent effects of COVID-19 on acute kidney disorders. Using data from the UK Biobank, the researchers conducted a matched cohort study and a Mendelian randomization analysis to explore both the association and potential causality between COVID-19 and AKD.

“Our research highlights the time-varying risk of acute kidney disorders in COVID-19 patients, particularly in the first three weeks following infection,” said Dr. Li Chunyang, a research associate at the West China Biomedical Big Data Center, West China Hospital, Sichuan University. “We observed that the hazard effects peak in the second week post-infection and decline by the fourth week.”

The study involved 10,121 COVID-19 patients matched with 29,004 unexposed historical controls based on age, sex, deprivation index, and hospitalization status. A conditional and time-varying Cox proportional hazard regression model was used to assess the association between COVID-19 and AKD within four weeks of infection. The results indicated that the risk of AKD peaked during the second week after infection (hazard ratio, 12.77; 95% confidence interval, 5.93–27.70) and decreased by the fourth week (hazard ratio, 2.28; 95% confidence interval, 0.75–6.93).

The study also found that only patients with moderate to severe COVID-19 showed a significant risk of acute worsening of renal function. This risk was not observed in patients with mild COVID-19. A one-sample Mendelian randomization analysis further demonstrated a potential “short-term” causal effect of COVID-19 on AKD risk, primarily confined to the first week after infection.

The findings suggest that healthcare providers should closely monitor kidney function in COVID-19 patients, particularly those with moderate to severe cases, during the critical first few weeks after infection. The study provides important insights into the temporal nature of COVID-19’s impact on kidney health, which may guide clinical management and follow-up strategies.

Looking ahead, the research team plans to further explore the time-varying impact of COVID-19 on the risk of incident acute kidney disorders in East Asian populations. Additionally, they aim to investigate the underlying molecular mechanisms that may link COVID-19 to subsequent acute kidney disorders to establish more definitive causal pathways.

“The molecular mechanisms behind the association between COVID-19 and kidney damage remain unclear,” added Dr. Zeng Xiaoxi, an associate professor in the Nephrology Department at West China Hospital. “Our future research will focus on elucidating these mechanisms and verifying causality, which could pave the way for targeted interventions.”

Reference:

Chunyang Li, Chao Zhang, Jie Chen, Yilong Chen, Zhiye Ying, Yao Hu, Huan Song, Ping Fu, Xiaoxi Zeng. The Time-Varying Impact of COVID-19 on the Acute Kidney Disorders: A Historical Matched Cohort Study and Mendelian Randomization Analysis. Health Data Sci. 2024;4:0159.DOI:10.34133/hds.0159.

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Pelvic Inflammatory Disease linked to Increased Risk of Serous Borderline Ovarian Tumors, study

Sweden: A recent nationwide case-control study conducted in Sweden has uncovered a significant association between pelvic inflammatory disease (PID) and an elevated risk of developing borderline ovarian tumors (BOTs).

The research, published in the International Journal of Cancer, indicates that individuals with a history of PID face a 48% increased likelihood of being diagnosed with these tumors, specifically highlighting a stronger correlation with serous tumors compared to mucinous types. Moreover, a dose-response relationship was identified, indicating that a greater number of PID episodes is associated with an elevated risk of serous tumors.

While pelvic inflammatory disease has been associated with tubo-ovarian carcinoma, its relationship with borderline ovarian tumors (BOT) remains less clear. This population-based case-control study utilizing Swedish national registers revealed that PID diagnosed before BOT development was linked to serous BOT but not to mucinous BOT. Additionally, a significant trend showed an increased BOT risk corresponding to the number of PID episodes. These findings suggest that infections of the fallopian tubes and adjacent tissues may elevate the risk of serous BOT.

The similarity between fallopian tube cells and serous borderline ovarian tumors points to a potential origin link, with salpingitis suggested as a contributing factor in the development of BOTs. Considering this, Sarah Jonsson, Department of Clinical Sciences, Obstetrics and Gynecology, Umeå University, Umeå, Sweden, and colleagues aimed to investigate the potential relationship between pelvic inflammatory disease (PID) and the risk of developing BOT.

For this purpose, the researchers conducted a national population-based case-control study in Sweden, including women diagnosed with borderline ovarian tumors from 1999 to 2020, along with ten matched controls. They analyzed data from nationwide registers using conditional logistic regression, adjusting for factors such as age, residential district, educational level, and parity.

The following were the key findings of the study:

  • Among 4782 cases and 45,167 controls, 2.0% of cases and 1.3% of controls had a history of PID.
  • Previous PID was associated with an increased risk of BOT overall (aOR, 1.48).
  • A significant association was observed with serous tumors (aOR, 1.76), while not with mucinous tumors (aOR, 0.95).
  • A dose-response relationship was noted between the number of PID episodes and serous BOT risk.

“This study shows that pelvic inflammatory disease is linked to a heightened risk of serous borderline ovarian tumors, with evidence of a dose-response relationship. The findings emphasize the significant implications of upper reproductive tract infections and inflammation. This highlights the necessity for further exploration of the biological mechanisms involved and the potential effects of PID on the development of serous BOT,” the researchers concluded.

Reference:

Jonsson, S., Jonsson, H., Lundin, E., Häggström, C., & Idahl, A. Pelvic inflammatory disease and risk of borderline ovarian tumors: A national population-based case–control study in Sweden. International Journal of Cancer. https://doi.org/10.1002/ijc.35180

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What Will Happen if Respiratory Medicine Dept Goes Away from 706 Medical Colleges? HC to decide on NMC Decision

Nagpur: While considering the plea by the Indian Chest Society (ICS) challenging the National Medical Commission’s (NMC) decision of eliminating the Respiratory Medicine Department from the MBBS curriculum, the Nagpur bench of Bombay High Court recently sought to know from the NMC the rationale behind such decision.

During the proceedings, the HC bench comprising Justice Bharti Dangre and Justice Abhay Mantri noted the argument that if the subject is eliminated, it means that the teaching staff for these courses or the department of respiratory medicine setup for this purpose would also be unavailable at 706 medical colleges across the country, which in turn would affect the healthcare facilities and the treatment of ordinary citizens.

Medical Dialogues reported that last year, the Undergraduate Medical Education Board (UGMEB) of the National Medical Commission (NMC) had removed three departments- Physical Medicine and Rehabilitation (PMR), Respiratory Medicine, and Emergency Medicine from the list of departments that every medical college/institution must have to be approved for undergraduate medical admissions on an annual basis. The provision for a separate department for respiratory medicine is also absent in the newly released Competency-Based Medical Education 2024 guidelines.

Even though the respiratory medicine specialists had approached different authorities urging to change this decision, they did not get any respite and decided to pursue the legal remedy. Accordingly, the Indian Chest Society (ICS) filed a Public Interest Litigation in this regard before the Bombay High Court. Apart from ICS, the Indian Association of Physical Medicine and Rehabilitation is also a petitioner in this case.

Also Read: MBBS Curriculum: Why are Respiratory Medicine Specialists at Loggerheads with NMC

During the previous hearing of the matter, the doctors’ counsel argued that UGMEB is required to function under the Act of 2019 and it is subject to the Regulations made by NMC as per Section 16 (2) of the Act of 2019. Further, the counsel pointed out that as per Section 57 of the 2019 Act, NMC is empowered to frame Regulations, and accordingly, on 28th October 2020, NMC framed Regulations as per which 24 Departments (including Departments of Respiratory Medicine, Physical Medicine, and Rehabilitation and Emergency Medicine) were identified to be established by every Medical College and Medical Institution approved for MBBS admissions annually.

As per the latest media report by The Hitavada, during the hearing of the case on Friday, the Apex Medical Commission informed the bench that these subjects will now be included as part of General Medicine. However, the Court underlined the importance of Respiratory Medicine during the COVID-19 pandemic and questioned the NMC’s decision to eliminate the course. Further, the HC bench also questioned the justification of including such an important topic in General Medicine.

The High Court bench has directed the Commission to provide a reasoned explanation for this decision within three weeks. Meanwhile, the petitioner association was asked to submit a reply.

Responding to the NMC’s argument that the subject would be part of General Medicine, the petitioner’s counsel argued that this would adversely affect the availability of doctors in hospitals for these critical subjects. Further, the counsel contended that the Commission’s decision would deprive medical students of crucial courses and also adversely impact the treatment of ordinary citizens. 

“Mr. Rahul Bhangde, learned counsel appear for the respondent nos.2 and 3 and seek time of three weeks to file reply. We expect the affidavit to be filed within a period of three weeks as undertaken,” ordered the HC bench.

“The petitioners are at liberty to file their rejoinder within a period of two weeks thereafter. Re-notify to 19th November, 2024,” it further mentioned in the order.

Speaking to Medical Dialogues regarding the NMC’s decision, Dr. Neel Thakkar, Vadodara-based pulmonologist and a member of the Indian Chest Society said, “The matter is not just about medical education, whether they teach respiratory medicine to MBBS students. But because of the department only and the absence of training , how many lives will be lost, how much Drug-resistant Tuberculosis and COPD will spread, how will this affect the mortality and morbidity should another pandemic strike our nation? All these questions need answers.”

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/bombay-hc-respiratory-medicine-255599.pdf

Also Read: Respiratory Medicine, Emergency Medicine, PMR Depts no longer mandatory to start new medical colleges, Doctors question move

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MBBS candidate Denied Sports Quota admission: Karnataka HC Directs State to Pay Rs 10 Lakh compensation

Bengaluru: While considering the plea by an MBBS aspirant, who was denied a seat under the sports quota despite representing India in several national and international chess tournaments, the Karnataka High Court recently directed the State Government to pay Rs 10 lakh to the student within six weeks from the date of order i.e. 01.10.2024.

The petitioner student is a chess player and she participated in various State/National and International Chess events. She had participated in the 32nd National U-13 Open and Girls Chess Championship 2018, the 7th National School Chess Championship 2018, the Asian Youth Chess Championship 2018, and the Common Wealth Championship 2018.

Aspiring to become a Doctor, the petitioner cleared the National Eligibility-and-Entrance Test UG Examination of 2022-2023 and scored a good rank. Consequently, she filed an application seeking admission to the Government seats in the Medical Colleges against the sports quota.

As per the petitioner, she is to be considered as a Preference P-I or P-III candidate. However, she was given P-V and was placed at Serial Number 9 in the provisional eligibility list and representations to various authorities remained unsuccessful. Ultimately, during the pendency of the case proceedings, the petitioner was admitted to the MBBS course on a Private Seat incurring fees exceeding Rs 11 lakh.

While considering her plea, the HC Division bench of Chief Justice NV Anjaria and Justice KV Aravind observed that the State’s actions in denying the petitioner a seat under the sports quota and forcing her to get admitted to a private medical college was arbitrary.

The bench observed that the petitioner is to be considered as P-I by considering the Winning Certificate issued by the Asian Youth Chess Championship, 2018. “It is not in doubt that All India Chess Federation is recognized by the Ministry of Youth Affairs and Sports. The certificate issued by AICF on the participation of the petitioner in Asian Youth Chess Championship 2018 would evident representing the Country. In the light of the aforesaid reasons, the Certificate of Winning issued by Asian Youth Chess Championship, 2018 at Thailand is while representing the country,” noted the Court.

“As per Rule 9 read with Second Schedule, the Asian Championship is in the list of Super-A Games. The candidate who has won a medal while representing the country in the Super-A Games is to be categorized as P-I,” it further observed.

Accordingly, the bench held that the categorization of the petitioner as P-V is “on the face of it illegal”. “The respondent authorities have committed serious errors either due to non-application of mind or the arbitrary exercise of the power. This action of the respondent authorities has deprived the petitioner’s aspiration to pursue MBBS Course under Government seat reserved as sports quota,” it noted.

At this outset, the Court also noted that due to the arbitrary decision by the authorities, the ambition of the parents and the student in pursuing sports activity to claim incentive of preference for admission was totally shattered. “The Court is bound to recognize the volume of time and money spent on pursuing the sport, apart from sacrificing academic training. Another aspect to be noticed and recognized is the moment of pride for the nation that was brought about by winning the certificate,” it further observed. 

However, the Court observed that if at this stage, the authorities are directed to consider the petitioner under the sports quota as P-I category, the admissions already concluded would be disturbed and the seat that the petitioner was pursuing would be vacant if she were to shift her admission to the sports quota. Similarly, one of the candidates admitted under sports quota would be displaced. Therefore, the Court opined that “In that view, disturbing the admissions already finalized is neither permissible nor prudent.”

“Once the Court holds that the action of the respondent-State has resulted in suffering to the petitioner, applying the test of time constraints, the petitioner cannot be denied of redressal of sufferings. Once the remedy of admission under the sports quota is not viable, the other method to remedy the grievance is with adequate compensation,” it concluded.

The Court noted that the amount of fee fixed for admission to Government Medical College is Rs 50,000. The fee for government seats in private medical colleges in Rs 1,40,000 whereas for private seats it is Rs 11,88,000. “In the event, the petitioner was considered under P-I category, she would be eligible to secure admission either in Government college or a government seat in a private college which would not have exceeded Rs.1,44,000/- per year. As per the pleadings, the petitioner is admitted in a private college on a private seat,” noted the Court.

Accordingly the Court ordered that being denied the opportunity to be admitted as a P-I candidate, the petitioner was entitled to compensation of Rs 10 lakh. “For the aforesaid reasons, the writ petition is allowed to the extent that the respondent-State is directed to pay compensation of Rs.10,00,000/- within six weeks from the date of service of this order,” the High Court bench ordered.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/karnataka-hc-rs-10-l-255577.pdf

Also Read: Karnataka HC Upholds NMC Rule of Doing Away with Grant of Grace Marks in MBBS Exams, junks students’ plea

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Sun Pharmaceutical Industry gets CDSCO Panel nod to study Aflibercept Injection

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug major Sun Pharmaceutical Industries to conduct the Phase III clinical study of Aflibercept injection 40 mg/mL, 0.278 mL/vial in patients with neovascular age-related macular degeneration.

This came after the firm presented the protocol to conduct a Phase III clinical study of Aflibercept injection at 40 mg/mL and 0.278 mL/vial in patients with neovascular age-related macular degeneration titled “A Prospective, Multicenter, Double-Blind, Active-Controlled, Parallel-Group, Phase III Study to Compare the Efficacy, Safety and Immunogenicity of Sun’s Aflibercept with Reference Biologic in Patients with Neovascular Age-Related Macular degeneration (wet AMD)” vide Protocol No. ICR/24/006, Version No. 1.0; dated 18.6.2024.

However, the nod is subject to the condition that the follow-up duration of the study should be increased to 6 months and a subsequent dose of the study drug should be provided to the study subjects if required based on the observation during the follow-up study duration.

Furthermore, the condition added that all the proposed primary and secondary efficacy endpoints should be evaluated at 6 months (24 weeks) in addition to the safety.

In addition to the above, the condition stated that for the standard care treatment, Ranibizumab should be used if required along with other medications.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor used to treat Neovascular (Wet) Age-Related Macular Degeneration (AMD), various types of macular edema and diabetic retinopathy, and metastatic colorectal cancer.

Aflibercept is a recombinant protein composed of the binding domains of two human vascular endothelial growth factor (VEGF) receptors, VEGFR1 and VEGFR2, fused with the Fc region of human immunoglobulin gamma 1 (IgG1).

At the recent SEC meeting for ophthalmology held on September 19, 2024, the expert panel reviewed the protocol for conducting a Phase III clinical study of aflibercept injection, which was submitted by the drug major Sun Pharmaceutical Industries.

After detailed deliberation, the committee recommended the conduct of the proposed Phase III study with the following changes in the protocol:

1. Follow-up duration of the study should be increased to 6 months and subsequent dose of study drug should be provided to the study subjects if required based on the observation during the follow up study duration. All the proposed primary and secondary efficacy endpoints should be evaluated at 6 months (24 weeks) in addition to the safety.

2. For the standard care treatment, Ranibizumab should be used if required along with other medications.

Accordingly, the expert panel stated the firm should submit the revised protocol to CDSCO for evaluation.

Also Read: CDSCO becomes Affiliate Member of International Medical Device Regulators Forum

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