HSP90 inhibition novel mechanism for treating hidradenitis suppurativa: JAMA

Denmark: Findings from a parallel-design, double-blind trial published in JAMA Dermatology have offered a potential new therapeutic option for treating hidradenitis suppurativa (HS). The study suggests the feasibility of HSP90 inhibition as a novel mechanism of action in HS treatment.

The trial of 15 patients showed that heat shock protein (HSP) 90 inhibition by oral RGRN-305, 250 mg, once daily led to a robust treatment response (n=10) versus placebo (n=5) after 16 weeks of treatment. Treatment-emergent adverse events (TEAEs) were not serious and were similarly frequent between the two groups (RGRN-305 and placebo).

Hidradenitis suppurativa is an immune-mediated, chronic, inflammatory skin disease that profoundly negatively influences the patient’s quality of life, affecting approximately 1% of the population. It has limited treatment options, hence, there is a need for new treatments.

Hakim Ben Abdallah, Department of Dermatology and Venereology, Aarhus University Hospital, Aarhus, Denmark, and colleagues aimed to evaluate the feasibility of HSP 90 inhibition by RGRN-305 as a novel mechanism of action for the treatment of moderate to severe hidradenitis suppurativa.

The study included a 1- to 30-day screening period, a 16-week treatment period, and a 4-week follow-up period. It recruited individuals aged 18 years or older and moderate to severe hidradenitis suppurativa with six or more abscesses or inflammatory nodules in at least two distinct anatomic regions. Of the 19 patients screened, the study enrolled 15 patients (67% female; median age, 29 years). An intention-to-treat analysis was performed.

Patients were randomly assigned in a ratio of 2:1 to receive oral RGRN-305, 250-mg tablet, or matching placebo once daily for 16 weeks. The primary efficacy endpoint was the percentage of patients achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR-50) at week 16.

The study led to the following findings:

  • The primary endpoint HiSCR-50 at week 16 was achieved by a higher percentage in the RGRN-305 group (60%) than in the placebo group (20%).
  • Improvements were also observed across all secondary endpoints at week 16, including higher rates of the harder-to-reach HiSCR levels; 50% achieved HiSCR-75 and 30% achieved HiSCR-90, whereas none of the placebo-treated patients achieved HiSCR-75 or HiSCR-90.
  • RGRN-305 was well tolerated, with no serious adverse events or deaths, and treatment-emergent adverse events were similarly frequent between the RGRN-305 and placebo groups.

“The findings of the randomized clinical trial suggest HSP90 inhibition by RGRN-305 to be a novel mechanism of action and a novel drug for HS treatment, providing good short-term safety and the potential to reduce the disease activity,” the researchers wrote.

“These data warrant further clinical evaluations in larger trials to confirm the safety and efficacy of the drug, and also to explore this novel mode of action in other immune-mediated skin disorders,” they concluded.

Reference:

Ben Abdallah H, Bregnhøj A, Emmanuel T, Ghatnekar G, Johansen C, Iversen L. Efficacy and Safety of the Heat Shock Protein 90 Inhibitor RGRN-305 in Hidradenitis Suppurativa: A Parallel-Design Double-Blind Trial. JAMA Dermatol. Published online December 06, 2023. doi:10.1001/jamadermatol.2023.4800

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Oral Factor XIa Inhibitor Milvexian Fails to Demonstrate Impressive Results for Preventing Stroke

People with factor XI deficiency have lower rates of ischemic stroke and infrequent spontaneous bleeding, presenting an essential role in thrombosis than in hemostasis. Milvexian, an oral small-molecule inhibitor of activated factor XI, may reduce the risk of non-cardioembolic ischemic stroke without increasing bleeding risk when added to standard antiplatelet therapy.

A recent study published in the Lancet Neurology concluded that Milvexian did not significantly reduce the composite outcome of ischaemic stroke or covert brain infarction when added to dual antiplatelet therapy and did not increase the risk of significant bleeding.

This study aimed to estimate the dose-response of milvexian for recurrent ischemic cerebral events and major bleeding in those with recent ischemic stroke or TIA (transient ischemic attack).

AXIOMATIC-SSP was a phase 2 dose-finding trial conducted at 367 hospitals across 27 countries. Eligible participants aged 40 or older with acute ischemic stroke or high-risk TIA were randomly assigned to receive one of five doses of milvexian or placebo twice daily for 90 days. All participants received clopidogrel and aspirin daily for the first 90 days. The primary endpoint was the composite of ischemic stroke or covert brain infarct at 90 days, assessed with MRI and analyzed with MCP-MOD. The main safety outcome was major bleeding at 90 days, evaluated in all participants who received the study drug.

Key findings are:

· 2366 participants were randomly allocated to placebo, milvexian 25 mg once daily, or twice-daily doses of milvexian 25 mg, 50 mg, 100 mg, or 200 mg

· The median age of participants was 71 years, and 859 were female.

· In patients with recent ischemic stroke or transient ischemic attack (TIA), randomization to any of five doses of milvexian did not significantly decrease the combined incidence of ischemic stroke or covert brain infarct on MRI at 90 days compared to placebo.

· Model-based relative risk estimates for milvexian versus placebo were 0.99 for 25 mg once daily, 0.99 for 25 mg twice daily, 0.93 for 50 mg twice daily, 0.92 for 100 mg twice daily, and 0.91 for 200 mg twice daily.

· No significant dose response was observed for the primary efficacy outcome, nor was one observed for major bleeding

· Five deaths happened during the study, four unrelated to the drug.

Our study has informed the design of a phase 3 trial for Milvexian’s prevention of ischaemic stroke in patients with acute ischaemic stroke or TIA, they added.

Bristol Myers Squibb and Janssen Research & Development funded the study.

Reference:

Sharma, M. et al. Safety and efficacy of factor XIa inhibition with milvexian for secondary stroke prevention (AXIOMATIC-SSP): a phase 2, international, randomized, double-blind, placebo-controlled, dose-finding trial. The Lancet Neurology, 23(1), 46–59. https://doi.org/10.1016/s1474-4422(23)00403-9

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Mental Health Challenges may persist among obese adolescents even after Bariatric Surgery

A comprehensive study delved into the mental health implications of bariatric surgery in adolescents dealing with severe obesity. The study revealed that adolescents with severe obesity who underwent bariatric surgery exhibited a higher incidence of psychiatric diagnoses and prescribed psychiatric drugs compared to their matched counterparts in the general population.

This study was published in the journal The Lancet: Child and Adolescent Health by Gustaf Bruze and colleagues. This retrospective analysis, using data from the Scandinavian Obesity Surgery Registry between 2007 and 2017, tracked psychiatric health-care visits and prescribed psychiatric drugs for 1554 adolescents who underwent bariatric surgery. These adolescents were matched with a control group of 15,540 adolescents from the general population. The key findings of the study were:

Prevalence of Psychiatric Health Care and Prescriptions: Before surgery, 95 (6.2%) of the surgery patients and 370 (2.5%) of the matched general population had a psychiatric health-care visit. Meanwhile, 127 (9.8%) of the surgery patients and 445 (3.6%) of the matched population filled psychiatric drug prescriptions.

Pre-Surgery Trends: The prevalence of psychiatric health-care visits and filled prescriptions increased leading up to the time of surgery. However, the rate of increase was notably higher among adolescents with severe obesity, with 208 (13.4%) of the surgery patients and 844 (5.5%) of the matched population having a psychiatric health-care visit a year before surgery.

Post-Surgery Trajectories: Mental health challenges persisted after surgery. The prevalence of psychiatric diagnoses and prescriptions continued to rise for both groups over the 10-year follow-up period after surgery. Notably, 171 (36.5%) of the surgery patients and 739 (16.0%) of the matched population filled psychiatric drug prescriptions 10 years after surgery.

Substance Use Disorder: The prevalence of health-care visits associated with substance use disorders notably increased post-surgery in the bariatric surgery group, with 24 (5.1%) of the surgery patients and 37 (0.8%) of the matched population having a health-care visit associated with a substance use disorder diagnosis 10 years after surgery.

Importantly, both groups experienced an escalating trend in mental health challenges leading up to surgery, with this trend persisting even after the surgical intervention. Understanding and addressing the mental health implications post-surgery are crucial for comprehensive care in this vulnerable population. Realistic preoperative discussions on mental health outcomes are imperative to provide adequate support and care for adolescents undergoing bariatric surgery.

Reference:

Bruze, G., Järvholm, K., Norrbäck, M., Ottosson, J., Näslund, I., Söderling, J., Reutfors, J., Olbers, T., & Neovius, M. Mental health from 5 years before to 10 years after bariatric surgery in adolescents with severe obesity: a Swedish nationwide cohort study with matched population controls. The Lancet. Child & Adolescent Health,2023. https://doi.org/10.1016/s2352-4642(23)00311-5

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Arthroscopic rotator cuff suture and 360° capsular release may improve shoulder movement in rotator cuff tear

A recent study has shed light on an innovative approach to treating full-thickness rotator cuff tears, offering promising results for patients with limited shoulder movement. The research investigated the clinical efficacy of arthroscopic rotator cuff suture combined with 360° capsular release, aiming to enhance the Constant-Murley score, Visual Analogue Scale (VAS) score, and shoulder flexion angle in affected individuals.

This study was published in the journal BMC Surgery by Jianwei Zuo and colleagues. Fifty-one patients with full-thickness rotator cuff tears and restricted shoulder movement were enrolled, receiving treatment between October 2017 and October 2020. All patients underwent arthroscopic rotator cuff suture coupled with 360° capsular release. Shoulder joint function was evaluated pre-treatment and during follow-up using the Constant-Murley score, VAS score, shoulder flexion angle, and assessment of rotator cuff healing via MRI with the Sugaya classification.

  • Improvement in Scores: Post-treatment assessments revealed significant enhancements in various parameters. The Constant-Murley score notably improved from 29.33 ± 9.71 to 58.98 ± 9.84, VAS score reduced significantly from 7.54 ± 1.22 to 1.23 ± 0.87, and shoulder flexion angle increased significantly from 51.50 ± 2.10° to 142.67 ± 8.59° (P < 0.05 in all cases).

  • Clinical Implications: The combined approach of arthroscopic rotator cuff suture and 360° capsular release demonstrated a remarkable and statistically significant impact on improving shoulder joint function in patients with limited movement due to rotator cuff tendinopathy.

The study highlights the notable efficacy of the simultaneous application of arthroscopic rotator cuff suture and 360° capsular release in enhancing shoulder function and alleviating symptoms associated with rotator cuff tears and limited shoulder movement. This innovative treatment strategy holds promise for addressing the challenges posed by rotator cuff tendinopathy, potentially offering improved outcomes and enhanced patient quality of life.

Reference:

Zuo, J., Chen, C., Guo, J., Lin, J., You, T., Chen, P., Li, C., & Li, W. Efficacy of rotator cuff suture and arthroscopic 360° capsular release in patients with rotator cuff tear with limited shoulder movement. BMC Surgery,2023;23(1). https://doi.org/10.1186/s12893-023-02157-6

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Brilaroxazine exhibits positive results for Schizophrenia in Phase 3 trial

Reviva Pharmaceuticals Holdings, Inc. reported the successful completion of its key Phase 3 RECOVER trial for brilaroxazine, which represents a significant advancement for the treatment of schizophrenia. The outcomes have been promising in the trial, it assessed the safety, tolerability, and effectiveness of once-daily brilaroxazine, a serotonin-dopamine signaling modulator, in individuals with schizophrenia.

The pivotal trial achieved its primary aim, showing that the 50 mg dose of brilaroxazine reduced the Positive and Negative Syndrome Scale (PANSS) total score by 10.1 points when compared to a placebo, a statistically significant and clinically meaningful difference. This result represents a major breakthrough in the management of schizophrenia, a condition that affects over 24 million people globally.

In addition to the primary endpoint, brilaroxazine achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 compared to the placebo. This includes positive and negative symptoms, personal and social performance, and PANSS Social Cognition. The broad efficacy profile, coupled with low discontinuation rates and favorable tolerability, suggests that brilaroxazine could address the limitations of current standards of care and offer a long-term treatment option for schizophrenia.

The clinical safety and tolerability findings of brilaroxazine further support its potential as a treatment option. No drug-related serious adverse events were observed, and there was no incidence of suicidal ideation. Additionally, there were no significant changes in body weight, blood glucose levels, lipid levels, or endocrine hormones when compared to the placebo. Akathisia and extrapyramidal symptoms were reported in less than 1% of patients taking brilaroxazine.

Reviva Pharmaceuticals plans to initiate a registrational Phase 3 RECOVER-2 trial in the first quarter of 2024, with the aim of supporting a New Drug Application (NDA) submission to the FDA in 2025. This advancement could significantly improve treatment options for individuals living with schizophrenia, providing hope for better management and enhanced quality of life.

Laxminarayan Bhat, the Founder, President, and CEO of Reviva, expressed excitement about the results and emphasized the multifaceted mechanism of action of brilaroxazine, which could potentially address key disease drivers like neuroinflammation. The long-term data from the ongoing OLE trial is expected to be reported in the fourth quarter of 2024, further adding to the growing body of evidence supporting brilaroxazine as a promising treatment for schizophrenia.

Reference: 

B2i. (2023, October 30). Reviva announces Positive topline results from global pivotal phase 3 RECOVER trial of brilaroxazine in schizophrenia. Reviva Pharmaceuticals. 

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Zinc supplementation with diet and exercise may improve metabolic outcomes in NAFLD patients

A recent randomised, double-blinded, controlled clinical trial has unveiled promising results regarding the potential of zinc (Zn) supplementation as an adjunctive therapy for managing Non-Alcoholic Fatty Liver Disease (NAFLD). This study, conducted over an 8-week period, included 50 overweight or obese participants diagnosed with NAFLD. This study was published in BMC Nutrition by Seyed M. and colleagues.

The trial divided participants into two groups, with 25 individuals in each group. One group received a daily dose of 30 mg of zinc, while the other received a placebo. Both groups were instructed to adhere to a balanced energy-restricted diet and recommended physical activity levels throughout the study duration.

The results of the study demonstrated significant improvements in several parameters among participants who received zinc supplementation:

  • Increased Zinc Levels: The zinc-supplemented group showed a substantial increase in zinc serum levels (P < 0.001).
  • Anthropometric Changes: A noteworthy decrease was observed in weight (P = 0.004), body mass index (BMI) (P = 0.002), and waist circumference (P = 0.010) within the zinc-supplemented group.
  • Metabolic Improvements: Zinc supplementation led to reduced levels of aspartate transaminase (AST) (P = 0.033), total cholesterol (TC) (P = 0.045), and low-density lipoprotein cholesterol (LDL-C) (P = 0.014).

However, the study did not find significant changes in other parameters such as alanine transaminase (ALT), fasting blood sugar (FBS), insulin, homeostasis model assessment of insulin resistance (HOMA-IR), high-density lipoprotein (HDL), triglyceride (TG), high-sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), and total antioxidant capacity (TAC) (P > 0.05).

The outcomes of this trial suggest that an 8-week regimen of daily 30 mg zinc supplementation exhibited beneficial effects in NAFLD patients. Notably, it increased zinc serum levels and contributed to improvements in weight, BMI, waist circumference, as well as markers of liver health and lipid profile. Despite these promising findings, the study highlighted the need for further research to validate and expand upon these results.

These results underscore the potential of zinc supplementation as a complementary therapeutic approach for NAFLD. The study’s implications may pave the way for future investigations and interventions aimed at refining treatment strategies for individuals with this prevalent liver condition.

Reference:

Rezaei, S. M. A., Mohammadi, F., Eftekhari, M. H., Ejtehadi, F., Ghaem, H., & Mohammadipoor, N. The effects of zinc supplementation on the metabolic factors in patients with non-alcoholic fatty liver disease: a randomized, double-blinded, placebo-controlled clinical trial. BMC Nutrition,2023;9(1). https://doi.org/10.1186/s40795-023-00776-z 

 

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Moringa oleifera leaves are effective for hypersensitivity and formation of biomimetic cementum tissue

Moringa oleifera leaves are effective for hypersensitivity and formation of biomimetic cementum tissue suggests a new study published in the Scientific Reports.

A study was done to evaluate the biomimetic remineralization capabilities of Moringa oleifera leaves (MOL) extract on coronal dentin and acellular cementum, two different concentrations (50 and 200 mg/ml) of MOL extract loaded in plain varnish (M1 and M2 groups respectively) were compared to fluoride varnish (FL group) and native surface (C group). Eighty sound premolar teeth were collected. Forty teeth (10 teeth in each group) were used for coronal dentin testing while the other forty (10 teeth in each group) were used for acellular cementum testing. Teeth in M1, M2, and FL groups were etched for 30 s and then received the specific varnish treatment.

All samples were immersed in artificial saliva for 14 days and then collected, dried, and examined by scanning electron microscopy and energy dispersive X-ray spectroscopy (EDX). Histologically, FL group showed mineral deposition as discrete vesicular granules of various sizes on the surface of both coronal dentin and acellular cementum. Mineral deposition only occurred on some DTs openings while opened tubules remained. The surface of the acellular cementum revealed regular grooves, micro-fissures, and cracks. In the M1 and M2 groups, mineral deposition appeared as a homogenous continuous layer on coronal dentin and acellular cementum. Only a few DTs and cementum fissures were not filled completely. In L.S. sections of the coronal one-third, the DTs appeared almost sealed with varying lengths of mineral deposition. EDX results statistical analysis showed that the M2 group had the highest phosphate ions (P−) and calcium ions (Ca+2) at%.

MOL has an extraordinary effect on the remineralization of coronal dentin and acellular cementum. It would have a promising ability to control dentinal hypersensitivity and formation of biomimetic cementum tissue.

Reference:

Obeid, R.F., Ammar, M.M. & Younis, S.H. Dentinomimetics and cementomimetics of Moringa oleifera leaves extract. Sci Rep 13, 19243 (2023). https://doi.org/10.1038/s41598-023-46656-1

Keywords:

Obeid, R.F., Ammar, M.M. & Younis, S.H, Dentinomimetics, cementomimetics, Moringa, oleifera, leaves, extract, Sci Rep

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Intranasal Palivizumab Fails to Prevent RSV Infection in Preterm Babies

A recent double-blind, randomized placebo-controlled trial found that daily intranasal palivizumab, a mucosal monoclonal antibody (mAb) did not prevent Respiratory Syncytial Virus (RSV) infection in late preterm infants. The findings were published in eClinicalMedicine of Lancet.

A total of 268 infants were enrolled from January 14, 2019 to January 28, 2021, with half receiving intranasal palivizumab and the other half a placebo once daily during the RSV season. The trial was halted for futility following a planned interim analysis.

Adverse events were observed to be similar in both groups, with 22 (16.4%) in the palivizumab arm and 26 (19.4%) in the placebo arm. But, 168 infants were excluded from efficacy analyses due to the absence of RSV circulation during the SARS-CoV-2 pandemic.

The primary outcome  showed no significant difference between groups (38.3% in the palivizumab arm versus 23.4% in the placebo arm) in regard to RSV infection. Also, the findings underscore the importance of timely interim analyses in mucosal mAb clinical development.

The outcomes of this study questions the efficacy of intranasal palivizumab for preventing RSV infection in late preterm infants. The results carry broader implications for the clinical development of mucosal mAbs by emphasizing the importance of interim analyses and the need for further research to comprehend the half-life of mucosal antibody. This supports clinicians to reevaluate strategies in the pursuit of effective mucosal antibody-based interventions against respiratory pathogens.

Reference:

Mazur, N. I., Löwensteyn, Y. N., Terstappen, J., Leusen, J., Schobben, F., Cianci, D., van de Ven, P. M., Nierkens, S., Bont, L. J., Nibbelke, E. E., Buiteman, B., Rave, N., Putten, M. V., Smit-Kleinlugtenbeld, E. A., de Lege-Korstanje, J. P., Peetsold, M. G., Hulsmann, A., van Gool, S., Snepvangers, Y., … Schuurman, R. (2023). Daily intranasal palivizumab to prevent respiratory syncytial virus infection in healthy preterm infants: a phase 1/2b randomized placebo-controlled trial. In eClinicalMedicine (Vol. 66, p. 102324). Elsevier BV. https://doi.org/10.1016/j.eclinm.2023.102324

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Timely Publication of Medical College Assessment Reports on NMC Website: Plea in Madras HC

Chennai: The Madras High Court recently briefly heard a plea seeking the timely publication of medical college assessment reports for all academic years, before the commencement of All India Counselling on the National Medical Commission’s (NMC) official website. The case has been adjourned for further proceedings, till 19.01.2024.

Filing the plea, the petitioner Dr. Mohamed Khader Meeran has urged the HC bench to take immediate action to promptly publish the infrastructure assessment reports of medical colleges for the academic years 2023-2024, 2022-2023, 2021-2022, 2020-2021 etc. Further, he has also prayed to the court to ensure the availability of historical assessment reports on the NMC website.

After briefly hearing the matter, the HC bench comprising Chief Justice SV Gangapurwala and Justice Bharatha Chakravarthy listed the matter for further hearing on January 19, 2024.

Apart from the NMC, the other authorities who have been made a party in the case include the Central Government, the Director General of Health Services (DGHS), and the Medical Counselling Committee (MCC). On behalf of the petitioner, Advocate Mr. S. Mohamed Ansar M.L appeared during the hearing.

Also Read: Make all medical college assessment reports public: CIC tells NMC

The Issue: 

After NMC superseded the erstwhile Medical Council of India (MCI), NMC website replaced the MCI website in the new domain. Along with this, the data and other documents uploaded by MCI including the college assessment reports of the previous academic year were also removed from the MCI website.

Raising this issue, Dr. Meeran had previously filed an RTI application and sought the medical college assessment reports for the academic year 2020-2021 and 2021-2022.

However, it was denied by NMC on the ground that “the information sought is very voluminous and scattered in various files. It would disproportionately divert the resource of MARB of NMC.”

Dissatisfied with the information furnished, he approached CIC and filed a complaint and argued that the concerned assessment reports are public documents under Section 4 (1) (b) of Right to Information Act and it is supposed to be pro-actively disclosed by CPIO of NMC.

Referring to the earlier order of CIC asking erstwhile MCI to disclose the assessment reports of the medical colleges, the complainant had further argued that NMC being the legal successor of MCI is liable to disclose the assessment reports as the CIC order to MCI is binding to NMC’s CPIO.

While considering the complaint, last year the CIC advised the NMC to upload the medical college assessment reports for the current academic year on the NMC website.

“There are two more orders regarding the assessment reports, issued by CIC to the Medical Council of India (MCI) in the past, which are binding to the National Medical Commission as of today. However, the NMC has not adhered to these orders. In a surprising turn of events, the NMC introduced a new regulation published in the gazette on 2nd June 2023, nullifying the CIC orders. The regulation states that only final assessment results will be declared, omitting the publication of comprehensive assessment reports prepared after physical inspections,” mentioned Dr. Meeran.

Medical Dialogues had earlier reported that Section 25 of the “Establishment of Medical institutions, Assessment & Rating Regulations, 2023″, which was recently published in the Gazette of India on June 02, 2023 mentions-

“Publication of rating – the MARB shall make available on its website or otherwise in the public domain the latest annual assessment results and ratings of medical colleges or medical institutions, in such a manner as to facilitate public understanding and consumption.”

These new rules suggest that NMC will only publish the “latest annual assessment results and ratings of medical colleges” replacing the previous practice of erstwhile MCI of uploading assessment reports of every medical college. Further, according to the newly implemented rules, only the “latest” annual assessment results will be available in the public domain, whereas all assessment reports over the years for a specific medical institute used to be available on the website of erstwhile MCI.

When Dr. Meeran approached the Commission again and cited the violation of the CIC orders, NMC claimed that it has complied the CIC’s order by publication of the above-mentioned regulations. However, within a week, the NMC responded to another RTI application filed by the petitioner to provide assessment report of Stanley medical college (Chennai), NMC refused by stating that medical college assessment reports contain personal information and it cannot be shared, mentioned Dr. Meeran.

Earlier, Dr. Meeran had also sent a representation in this regard through the Prime Minister Office Grievance portal. 

Plea in Madras High Court: 

Thereafter, he approached the Madras High Court and filed a plea, which was heard on January 03, 2024 by the division bench headed by Hon’ble Chief Justice Gangapurwala and Hon’ble Justice Bharatha Chakravarthy.

In the plea, the petitioner has questioned, if the CIC orders were compiled by NMC and how it can refuse sharing the assessment reports and deny to disclose the assessment reports of the Stanley Medical College.

The petitioner referred to his RTI application dated 09.03.2022, where he asked NMC whether any policy decision was taken by NMC not to disclose medical college assessment reports, and whether any order/advisory/direction was issued by the Central Government not to disclose the medical college assessment reports.

However, on June 13, 2022, the Central Public Information Officer (CPIO) of NMC replied that neither such policy decision was taken nor any order/advisory/direction from the Central Government was received in this regard.

Referring to the concerned RTI reply, the petitioner submitted that “In the absence of any policy decision, why the assessment reports were deleted from the website and also why the practice of publishing the assessment reports proactively by the legal predecessor MCI was abruptly discontinued by the Respondent No.3, is something to be probed on the interest of public spirit and Right to Health guaranteed under Article 21 of the Constitution of India.”

“…all the patients seeking healthcare from the hospitals attached to the medical colleges/ institutions are entitled to know the standard of care provided at the hospital, details regarding health workforce etc in that particular hospital. To ensure patients are getting these legal rights in healthcare facilities, ensure standard level of care offered etc its necessary to periodically disseminate the infrastructure & faculty assessment reports of medical colleges with larger public interest,” the plea added.

Referring to the Establishment of Medical Institutions, Assessment and Rating Regulations, 2023, the plea alleged that these regulations not only violates the Right to Information Act & Central Information Commission orders, but also compromises the quality of healthcare offered to the crores of Indian citizens.

Further, the plea also addressed NMC’s denial to provide the assessment reports for Stanley Medical College on the ground that it contains personal information.

The petitioner submitted that a medical college/institution assessment report has the name of the assessor/inspector and designation, number of beds in each department and the bed occupancy rate of those departments, number of lecture halls, operation theatres, presence of equipment and their working condition, other infrastructural details, name list of doctors and teaching faculties working in that institution, observations of the assessor/inspector during inspection, recommendation whether to sanction/deny approval for the current academic year admissions in that particular medical college.

It has been highlighted in the plea that the assessment reports do not have any personal information. The plea also relied upon the CIC order dated 28 June 2018.

Medical Dialogues had earlier reported that back in 2018, in a major decision for the cause of transparency, the CIC had directed the erstwhile MCI to make the inspection reports of all medical institutes in the country public.

Also Read: Make public full report of MCI inspection of medical colleges within 6 weeks: CIC to MCI

“Keeping assessment reports hidden in files away from public gaze is counter-productive for an efficiency of medical education system as prevailing in the nation,” Information Commissioner Yashovardhan Azad had mentioned in his order.

Further referring to the fact that NMC is the legal successor of the erstwhile MCI, the Plea pointed out that as per Section 60(1) of the National Medical Commission Act, the NMC inherits the legal obligations of erstwhile Medical Council of India.

Therefore, the petitioner argued that considering this fact, any orders or directions issued to MCI, including the order of the Central Information Commission (CIC) are binding on NMC and therefore, the Commission is legally obligated to comply with the orders issued to the MCI.

“…disclosure of these assessment reports is crucial for ensuring transparency and accountability in the field of medical education. It enables aspiring medical students to make informed decisions about their choice of college, and it directly impacts the quality of education and the standard of healthcare professionals produced by these institutions. It is therefore my humble request to this Honorable Court to take cognizance of the NMC’s non-compliance with the CIC’s orders and its failure to fulfill its legal duties. I seek the Court’s intervention to ensure that the NMC promptly discloses the medical college assessment reports for the respective academic years as per the CIC’s order and in accordance with the provisions of the National Medical Commission Act and Right to Information Act,” the plea mentioned.

In respect of the UG and PG medical admission for the current academic year i.e. 2023-2024, the plea pointed out that NMC notified the assessment results for this academic year on 25.09.2023. It was disclosed to the public almost after the completion of all rounds All India quota counselling, as the admission cut off date to fill all MBBS seats were decided as 30.09.2023, alleged the petitioner.

“Due to this lack of disclosure of information, students had to choose seats through counselling without even having any reliable information about the list of medical institutions that were permitted to admit students for the current academic year, institutions’ infrastructure and faculty information etc. The assessment results disclosed by 3rd respondent has only the final decision regarding whether the approval/recognition for the academic year admission was granted or not. But the Central Information Commission orders were to publish full comprehensive assessment reports of medical institutions justifying the approval decision. It was contrary to 3rd respondent’s reply given through letter dt 20.07.2023, which stated that Central Information Commission order to publish assessment reports were complied,” mentioned the plea.

Therefore, filing the plea, the petitioner urged the court to grant the following prayers:

(i) to take immediate action to promptly publish the infrastructure assessment reports of medical colleges inspected by the 3rd respondent for the academic years 2023-24, 2022-23, 2021-22, 2020-21 etc.

(ii) to ensure the availability of historical assessment reports in the official website of the 3rd respondent;

(iii) to ensure timely publication of the latest infrastructure assessment reports of medical colleges inspected by the 3rd respondent for all academic years, prior to the commencement of the All-India counselling and admission process for each respective academic year in the future by considering the petitioner’s representation dated 05.07.2023 preferred to the respondents in accordance with law within the time stipulated by this Hon’ble Court and pass such further or other order as this Hon’ble Court may deem fit and proper in the circumstances of the case and thus render Justice.

Also Read: Why Can’t Medical College Reports be Made Public? Transparency Woes Plague NMC

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Submit Separate Toxicity Data on Indian Subject: CDSCO Panel Tells GSK on BelantamabMafodotin study

New Delhi: Considering the serious adverse events in the study data (phase-I & II) of Belantamab Mafodotin (GSK2857916) for Injection 100mg presented by drug major GSK Pharma, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should present separately the toxicity profile of Indian subjects.

This came after the drug major GSK Pharma presented the phase –I Clinical trial, protocol no. 209664.

The above study is a phase 3, randomized, open-label study of Belantamab Mafodotin administered in combination with Bortezomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone alone in participants with newly diagnosed multiple myeloma who are Ineligible for Autologous Stem Cell Transplantation.

Belantamab mafodotin is a medication for the treatment of relapsed and refractory multiple myeloma. The most common adverse reactions include keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.

Belantamab Mafodotin, the anti-BCMA antibody moiety selectively binds to BCMA on tumor cell surfaces. Upon internalization, the MMAF moiety binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces tumor cell apoptosis.

At the recent SEC meeting for Oncology and Hematology held on the 6th and 7th of December 2023, the expert panel reviewed the reviewed phase –I Clinical trial, protocol no. 209664.

After detailed deliberation, the committee stated,

“Considering the serious adverse events in the study data presented by the firm (phase-I & II), it should be further evaluated through detailed results of adverse events on the ongoing study for further cycle therapy.”
In addition, the expert panel suggested, “GSK Pharma should present separately the toxicity profile of Indian subjects.”

In line with the above, the committee opined that the proposal should be re-deliberated for further consideration.

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