Tirzepatide Therapymay significantly Reduce Effects of Obstructive Sleep Apnea in Obese Patients: NEJM

A recent study published in the New England Journal of Medicine suggests that tirzepatide which is primarily used to treat type 2 diabetes, may significantly improve the symptoms in patients with moderate-to-severe obstructive sleep apnea (OSA) and obesity. These two phase 3, double-blind, randomized, controlled trials highlights the potential of tirzepatide to become a novel treatment option for this serious condition.

The trials enrolled adults with moderate-to-severe OSA and obesity with the participants divided based on their use of positive airway pressure (PAP) therapy. Trial 1 included the individuals not using PAP therapy, while Trial 2 included participants already on PAP therapy. In each trial, the participants were randomly assigned to receive either the maximum tolerated dose of tirzepatide (10 mg or 15 mg) or a placebo for 52 weeks. The primary endpoint was the change in the apnea–hypopnea index (AHI), which measures the severity of sleep apnea by counting the number of apneas (pauses in breathing) and hypopneas (shallow breaths) per hour of sleep.

The baseline mean AHI was 51.5 events per hour in Trial 1 and 49.5 events per hour in Trial 2 that indicated severe OSA in participants. After 52 weeks, the results showed a dramatic reduction in AHI among the patients treated with tirzepatide when compared to the placebo group. In Trial 1, the AHI decreased by 25.3 events per hour in the tirzepatide group against a reduction of only 5.3 events per hour in the placebo group. Trial 2 showed a similar pattern with a reduction of 29.3 events per hour in the tirzepatide group when compared to 5.5 events per hour in the placebo group. These findings were statistically significant by suggesting that tirzepatide substantially reduces the severity of OSA.

Beyond AHI reductions, tirzepatide also led to significant improvements in several secondary endpoints. The participants underwent considerable weight loss, reduced hypoxic burden (the total time spent with low oxygen levels during sleep), lower high-sensitivity C-reactive protein (hsCRP) concentrations (a marker of inflammation) and decreased systolic blood pressure. Also, patient-reported outcomes regarding sleep impairment and disturbance showed significant improvements.

The findings of this study indicated that tirzepatide could become a vital treatment for individuals with moderate-to-severe OSA and obesity by offering significant reductions in AHI, weight and associated cardiovascular risk factors. Further research and real-world studies will be imperative to confirm these results and establish long-term safety and efficacy.

Source:

Malhotra, A., Grunstein, R. R., Fietze, I., Weaver, T. E., Redline, S., Azarbarzin, A., Sands, S. A., Schwab, R. J., Dunn, J. P., Chakladar, S., Bunck, M. C., & Bednarik, J. (2024). Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. In New England Journal of Medicine. Massachusetts Medical Society. https://doi.org/10.1056/nejmoa2404881

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Efficacy and Safety of Bimekizumab in Treating Hidradenitis Suppurativa Demonstrated in Phase 3 Trials

USA: Bimekizumab, a novel monoclonal antibody, has shown promising results in treating moderate-to-severe hidradenitis suppurativa (HS), a chronic inflammatory skin disease. The findings emerged from two pivotal phase 3 trials, BE HEARD I and BE HEARD II, randomized, double-blind, placebo-controlled studies spanning 48 weeks and conducted across multiple centers.

The study published in The Lancet revealed that bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses, maintained for up to 48 weeks.

“Data from these two trials support the bimekizumab use for treating patients with moderate-to-severe hidradenitis suppurativa,” the researchers wrote.

Hidradenitis suppurativa patients have substantial unmet clinical needs and scarce therapeutic options. Prof Alexa B Kimball, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA, and colleagues aimed to assess the safety and efficacy of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, in patients with moderate-to-severe HS.

BE HEARD I and II were two identically designed, 48-week randomized, placebo-controlled, double-blind, multicentre phase 3 trials. It included patients aged 18 years or older with moderate-to-severe hidradenitis suppurativa. They were randomly assigned 2:2:2:1 to receive subcutaneous bimekizumab 320 mg every two weeks; bimekizumab 320 mg every two weeks to week 16, then every four weeks to week 48; bimekizumab 320 mg every four weeks to week 48; or placebo to week 16, then bimekizumab 320 mg every two weeks.

The primary outcome was an HS clinical response of at least 50%, defined as a reduction in total abscess and inflammatory nodule count of at least 50% from baseline with no rise in abscess or draining tunnel count (HiSCR50) at week 16. Efficacy analyses included all randomly assigned study patients (intention-to-treat population). Safety analyses included patients who received at least one full or partial dose of study treatment in the safety set and bimekizumab in the active medication set.

The researchers reported the following findings:

· Patients for BE HEARD I were recruited from 2020 to 2021, and 505 patients were enrolled and randomly assigned. Patients for BE HEARD II were recruited from 2020 to 2021, and 509 patients were enrolled and randomly assigned.

· The primary outcome at week 16 was met in the group who received bimekizumab every two weeks using modified non-responder imputation; higher responder rates were observed with bimekizumab versus placebo in both trials: 48% of 289 patients versus 29% of 72 patients in BE HEARD I (odds ratio [OR] 2·23) and 52% of 291 patients versus 32% of 74 patients in BE HEARD II (2·29).

· In BE HEARD II, HiSCR50 was also met in the group administered bimekizumab every four weeks (54% of 144 vs 32% of 74 with placebo; 2·42).

· Responses were maintained or increased to week 48. Serious treatment-emergent adverse events were in 8% of patients in BE HEARD I and 5% of patients in BE HEARD II treated with bimekizumab over 48 weeks.

· The most frequently reported treatment-emergent adverse events to week 48 were hidradenitis in both trials, coronavirus infection and diarrhea in BE HEARD I, and oral candidiasis and headache in BE HEARD II.

· Across the two trials, there was one death due to congestive heart failure in a patient with substantial cardiovascular history treated with bimekizumab every two weeks in BE HEARD I (considered unrelated to bimekizumab treatment by the investigator).

· No new safety signals were observed.

The results of BE HEARD I and BE HEARD II trials have been submitted to regulatory authorities for review, with hopes that bimekizumab soon become available as a treatment option for HS.

Reference:

Kimball AB, Jemec GBE, Sayed CJ, Kirby JS, Prens E, Ingram JR, Garg A, Gottlieb AB, Szepietowski JC, Bechara FG, Giamarellos-Bourboulis EJ, Fujita H, Rolleri R, Joshi P, Dokhe P, Muller E, Peterson L, Madden C, Bari M, Zouboulis CC. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024 May 22:S0140-6736(24)00101-6. doi: 10.1016/S0140-6736(24)00101-6. Epub ahead of print. PMID: 38795716.

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Max Hospital, Head Microbiology slapped Rs 8 Lakh Compensation for misdiagnosing COVID-19, improper treatment

Chandigarh: The State Consumer Disputes Redressal Commission (SCDRC), Mohali recently directed Max Super Speciality Hospital and one of its doctors to pay Rs 8 lakh to a man for medical negligence during the treatment of his elderly mother back in 2020.

As per the complainant, the patient and her family had to suffer because of the wrong COVID-positive report given by the hospital. Earlier, the District Commission had directed the hospital and its Head of Microbiology department to pay Rs 5 lakh compensation. However, the State Commission increased the amount of compensation to Rs 8 lakh. 

The history of the case goes back to 2020 when the complainant’s mother fell down and consequently, x-ray reports showed that she had suffered a right leg femur fracture. Thereafter, the patient was taken to the treating hospital where the senior specialist doctor was not available. Another doctor attended the patient and after going through the report, the doctor opined that surgery was required which might take six days.

It was alleged that the treating doctor did not turn up after the patient was admitted and another doctor put the patient’s right leg on traction with 4 kg water weight. The complainant alleged that the specialist doctor had delegated his responsibility to the junior and did not attend to the patient and thereby he did not discharge their duty and function of diagnosis, advice and treatment as expected, which amounted to professional misconduct.

Therefore, the complainant alleged that the hospital should have sent the COVID-19 sample of the patient to PGI, Chandigarh, which could save time. However the hospital management took the sample to Max Hospital, Delhi for testing and the report showed that the patient was COVID-19 positive.

It was further alleged by the complainant that after a discussion with doctors at the hospital, another sample of the patient was sent to PGI, Chandigarh, and the reports showed that the complainants were COVID-negative.

The complainant submitted that despite his repeated requests, the patient was not shifted to PGI, Chandigarh and rather the complainant was asked to leave the private room. On 29.05.2020 evening, the complainants received their reports from PGI declaring all of them negative. 

Referring to this, the complainant argued that all of them including the patient were put to trauma because of the wrong report and even the complainants were put to illegal confinement. Following this, the complainant got his mother discharged from the treating hospital and clearing all the bills, they took the patient home.

As per the complainant, the patient was brought home on 31.05.2020 and she breathed her last on 03.06.2020 as she was kept under a heavy medical dose. He alleged that the patient was fine till 27.05.2020 except that her leg was fractured but things started taking twist once she was admitted to the treating hospital where on her admission, she was not found with any fever, cough, cold etc. It was further submitted by the complainant that the doctor and the hospital did not provide proper treatment to the patient nor did they provide a correct COVID report. 

On the other hand, the treating hospital and the doctor denied that there was any medical negligence, deficiency in service or unfair trade practice on their part.

While considering the matter, the District Commission had earlier ordered a compensation of Rs 5 lakh against the treating hospital and its doctor. However, challenging the District Commission’s order, the complainant approached the State Commission seeking an enhancement of the compensation.

SCDRC Chandigarh noted that the family members of the patient suffered due to the situation. 

“A misdiagnosis of COVID-19, especially for an elderly loved one, caused significant emotional distress and worry for the family. Being placed under home quarantine based on an inaccurate report (Annexure C-4 & C-6) disrupted daily life and also caused inconvenience. Even the public notices about COVID-19 positive cases led to social stigma on the complainants, even if, later proven negative,” noted the Commission.

“Thus, the alleged tampering with initial reports suggesting COVID-positive status, despite a negative test later (Annexure C-12), proved potential negligence on the part of opposite parties No.1 to 3 & 5. Further, the improper treatment i.e. administering medications for a non-existent condition and heavy doses for an unconfirmed heart condition was non-adherence to proper medical protocols. The mental and physical suffering of the patient brought distress due to the misdiagnosis and improper treatment given by opposite parties No.1 to 3 & 5 and thus, the unnecessary home quarantine and social stigma faced by the complainants (family) due to the misdiagnosis was proven deficiency in service and unfair trade practice on the part of opposite parties No.1 to 3 & 5, for which, the District Commission has rightly awarded compensation,” it further observed.

The State Commission observed that looking at the agony and suffering caused to the complainants due to aforesaid deficiency in service on the part of the hospital and its doctors the compensation awarded by the District Commission seemed to be “inadequate and on the lower side, which needs to be enhanced suitably.”

“It may be stated here that during the course of arguments, a Compatible Disk placed on record, was run in the Court Room, which was not clearly audible but to some extent, the patient i.e. the mother of complainant No.1 was heard of saying that she wanted to go home and kept on requesting complainant No.1 for taking her home. In this regard, it is apposite to mention here that being placed in isolation for suspected COVID-19, especially at an advanced age, could be incredibly lonely and frightening, which could lead to anxiety, depression and even delirium in some cases. The patient’s hearing difficulties (right ear) and vision problems (left eye) further exacerbated the isolation and confusion caused by being in an unfamiliar environment. The lack of familiarity with the staff due to PPE and the uncertainty surrounding the illness significantly heightened her (patient’s) fear and anxiety. Sensory deprivation, isolation, and underlying medical conditions certainly increased her risk of delirium. Thus, in our considered view, the compensation awarded by the District Commission to the tune of Rs.5 Lakh, if enhanced to Rs.8 Lakhs would meet the ends of justice as the mother of complainant No.1 even did not survive later on,” the Commission noted.

Accordingly, the State Commission increased the amount of compensation and directed the hospital and its Head of Microbiology department to pay Rs 8 lakh compensation to the complainants. Out of this Rs 8 lakh, Rs 7.5 lakh was to be paid by the hospital and Rs 50,000 by the doctor.

The Commission ordered the hospital and doctor “to pay lump sum amount of ₹8 Lakhs to the complainants, out of which, ₹7,50,000/- shall be paid by opposite parties No.1 to 3 and the remaining ₹50,000/- shall be paid by opposite party No.5, as compensation on account of the medical negligence as well as for the mental and physical pain and trauma suffered by the complainants and the amount spent by them on treatment of the patient; (ii) to pay ₹10,000/- to the complainants as costs of litigation.”

To read the order, click on the link below:

https://medicaldialogues.in/pdf_upload/scdrc-max-hospital-mohali–242625.pdf

Also Read: Not showing pacemaker to patient attendant before implantation constitutes deficiency:Gurgaon hospital directed to pay Rs 2 lakh compensation

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Doctors Submit Suggestions to Health Ministry for Union Budget 2024-2025 for healthcare

New Delhi: With the dates of the Budget 2024 approaching, the doctors have recently submitted their suggestions for the Union Budget 2024-2025 for healthcare.

The doctors under the Association of Healthcare Providers (AHPI) have suggested introducing incentives for the private sector to set up more hospitals, budgetary provisions for setting up PG colleges, new nursing colleges, and 300-bedded hospitals to operate as medical colleges.

Budget allocations have also been sought for disease eradication through adult immunization, strengthening of geriatric services, emergency & trauma care, mental health awareness etc.

Doctors have also urged the Government to consider restructuring the Insurance Sector, expanding telemedicine services, sanctioning more funds for medical research, and promoting medical tourism. It also requested the Government to exempt healthcare services availed by hospitals from paying GST.

The AHPI representatives offered these suggestions at the pre-budget consultation chaired by the Finance Minister on 27th June 2024. The suggestions given by the AHPI are as follows:

Incentives for Private Sector to Set up More Hospitals: 

AHPI pointed out that India has currently less than 2 beds as against the WHO norm of 3.5 beds per 1000 population. Opining that increasing the bed capacity should be of the highest priority, the association highlighted the existing regional disparity and suggested that the Government may announce incentives for the private sector like- cheaper loans, cheaper electricity, single window clearances and tax holidays as appropriate, to set up 100-bedded Ayushman Bharat hospitals in these regions.

Setting up More Medical & Nursing Colleges to Increase Human Resources: 

Highlighting the severe shortage of specialist doctors, nurses, and allied healthcare professionals in India, the association suggested that besides increasing the PG seats for doctors, the budget may provide 4-exclusive PG colleges like PGI Chandigarh. 

“Budgetary support is needed for the functioning of newly created bodies like; National Nursing & Midwifery Commission and National Commission for Allied & Healthcare Professionals. Budgetary support for 100-bedded hospitals to start Nursing College and likewise 300 plus bedded hospitals to operate medical college. This will enable meeting shortage at low cost compared to establishing new colleges,” it opined.

Promote Preventive Health Measures, Doctors Urge Ministry: 

AHPI has suggested to the Government to provide funds for promotive and preventive including making provisions for safe drinking water, sanitation and awareness on nutrition (millets etc.).

It urged the Government for urgent allocation to make Health & Wellness Centres effective as part of Ayushman Bharat. AHPI further pointed out the requirement for budgetary allocation for disease eradication through adult immunization against Influenza, HPV (for women against cervical cancer), Zoster and pneumococcal to mention few. Allocate resources for mental health awareness, diagnosis, and treatment facilities.

Strengthen Physical & Mental Healthcare: 

The association suggested creating facilities for senior citizens, including senior citizens in the PMJAY scheme, creating of special insurance fund with CSR contribution for affordable health insurance for senior citizens, and removing/reducing GST for senior citizens insurance. 

It also opined that the Government may establish exclusive emergency/trauma centres including empanelling those working at private hospitals to take care of road accident patients and those coming for cardiac and stroke incidents. Further, the association also opined offering mental health services at the Taluk level.

Restructure Insurance Sector: 

Pointing out that the Government has launched the world’s largest social health insurance scheme PMJAY covering 40% of India’s population, the association highlighted that 85% of tertiary care beds are with the private sector and opined that it is imperative to include the private sector. 

“For this government needs to fix reimbursement rates on a scientific basis and that would also require budgetary provision. Without participation from tertiary care hospitals, the scheme will not be able to achieve its objectives. The same applies to CGHS, ECHS and ESI. We may allow co-payment to bring more tertiary care hospitals within the scheme,” opined the association. 

Expand Telemedicine: 

AHPI suggested offering budgetary provisions to expand telemedicine services through the National Digital Health Mission to improve access to healthcare, especially in remote and rural areas. It also advised the Government to invest in digital health infrastructure to facilitate electronic health records and data management.

Strengthening Medical Research: 

The association suggested the government fund medical research and innovation to develop new treatments, vaccines, epidemiological statistical research etc. Need to encourage public-private partnerships in healthcare research.

Promoting Medical Tourism: 

It also advised the government to allocate funds to enhance infrastructure at appropriate destinations to attract and facilitate medical tourism and provide incentives like tax benefits.

GST: 

AHPI suggested that healthcare services availed by hospitals should be exempted from paying GST or be allowed to get credit. The association opined that this will be a step to make healthcare affordable. It also suggested granting industry status to the healthcare sector.

Also Read: With Union Budget 2024, medical devices cos hope for reduction in customs duties

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NPPA Authority rejects Abbott Healthcare’s application for separate retail price for Flagyl Gel with soft tip applicator

New Delhi: Noting the company did not submit any published literature/ clinical study/ evidence in support of the claim, the National Pharmaceutical Pricing Authority (NPPA) has rejected the drug major Abbott Healthcare’s application for a special retail price for the product “Flagyl Gel with Soft Tip Applicator” under Paragraph 11(3) of the Drug Price Control Order (DPCO), 2013.

This came after the authorities deliberated on the application received for special retail price for the product “Flagyl Gel with Soft Tip Applicator” under Paragraph 11(3) of the Drug Price Control Order (DPCO), 2013, for incremental innovation, at the 256th authority meeting, which is the 124th meeting under the DPCO, 2013, held on June 7, 2024, under the Chairmanship of Shri Kamlesh Kumar Pant, Chairman, NPPA.

The Authority noted that retail price for the formulation “Chlorhexidine Gluconate solution IP eq. to Chlorhexidine 1% w/w Metronidazole Benzoate IP eq. to metronidazole 1% w/w + Lignocaine Hydrochloride 2%w/w gel” has already been fixed for M/s Abbott Healthcare Pvt. Ltd. at Rs. 3.75 per gm vide SO No. 2123 (E) dated 04.05.2023.

Abbott Healthcare Pvt. Ltd. has applied for a special price under para 11(3) on account of Incremental Innovation for the same formulation titled “Flagyl Gel with Soft Tip Applicator” under para 11(3) of DPCO, 2013 vide application dated 25.10.2023.

Para 11(3) of DPCO, 2013, states,

“Notwithstanding anything contained in sub-paragraph (1) and (2), in the case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I of the Drugs (Prices Control) Order, 2013, the Government may fix and notify separate ceiling price or retail price for such formulations with specified therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage as the case may be, conforming to Indian Pharmacopeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation.”

Furthermore, the authority observed that the applicant has claimed special features like hands-free application, targeted application, mitigating cross contamination and spreading of bacteria, non-messy and controlled dispensing and improved compliance as the special features of the product.

The applicant has also mentioned that the design of the Soft Tip Applicator has been registered with the Office of CGPTD. It was noted that the applicant has claimed an additional cost of Rs. 25/- per Soft Tip Applicator + Shoulder Cap.

The Authority further disclosed that the subject was discussed at the 56th, 57th, and 59th MDC meetings, which were held on December 20, 2023, February 27, 2024, and May 8, 2024, respectively.
The representatives of the company gave a detailed presentation before the 57th MDC wherein the applicant was asked to submit following for their claim by the MDC:

i. Published literature/clinical study, or evidence that the applicator helps in administering the drug to improve the compliance of patients, compared to the same drug without the applicator.

ii. If the evidence for the benefit of the applicator is only in a subset of patients, the company may provide this detail.

iii. Comments regarding whether the applicator would be classified as a medical device.

iv. The quantum of the residual drug in the applicator.

v. Why this applicator needs to be sold with the drug itself? It is more like additional/optional package item that can be sold separately.

VI. Data with respect to bacterial load on multiple usage duly supported with clinical data

The Authority also mentioned that the Committee examined the submissions made by the applicant vide letter dated 02.04.2024 and it was held that the applicant had submitted a Patent application filed for European and US Patent but did not submit any Published literature/ clinical study/ evidence in support of the claim.

The MDC also did not find the report titled “A Day on the Field with our Sales force (Oro Care)” submitted by the company as satisfactory.

In addition to the above, the authority stated that the applicant has informed MDC that the applicator is designed to create a “drug-device combination”.

Accordingly, MDC stated that a ‘drug-device combination’ is a new drug for which a separate license is required as per NDCT rules 2019. However, the applicant has not submitted the same. Accordingly, the MDC deliberated upon the submissions of the company and rejected the claim.

In view of the above, the authority deliberated upon the matter in detail and decided to accept the recommendation of MDC and accordingly rejected the application of the company.

Also Read:NPPA Revises Ceiling Price of FDC Budesonide Plus Formoterol Inhalation

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Maharashtra Govt Approves 2 New Medical Colleges with 100 MBBS Seats Each

Mumbai: Bringing good news to the medical aspirants in Maharashtra, the State Government has approved two new medical colleges with an intake capacity of 100 MBBS seats each in Hingoli and Jalna in separate govt resolutions (GRs).

According to TOI report, although the State has given its approval, these medical colleges are still awaiting approval from the National Medical Commission (NMC). However, the students and parents are hoping for these medical institutes to be functional from the academic year 2024-2025.

Issuing GRs this week, the State informed that since the construction of the college buildings will take time, the Government will lease a ready-to-use private building, which is under construction.

Also Read: No More penalty for leaving MBBS, BDS seats midway in Uttar Pradesh

As per the latest media report by the Times of India, the State Budget was tabled on Friday. Except for a government Unani College in Raigad’s Mhasla taluka and a new Government Ayurveda College in Buldhana district, all the new medical colleges were already announced in the interim budget in February. These two new medical colleges were announced on Friday. 

The Daily has reported that Unani College will have an intake capacity of 100 students. Meanwhile, in this year’s budget, there was an increase in the allocation to the medical education department from the interim budget. The amount of allocation has increased by Rs 97 crore for the new posts created at these new colleges including Jalna, Bhandara, Gadchiroli, and Hingoli. This amount will be set aside for salaries and other expenses.

Taking note of the ratio of 84 doctors per lakh population, the budget highlighted the necessity to increase the ratio to more than 100 by the end of 2035. To achieve this goal, the budget stated that increasing the capacity in medical colleges is necessary. 

In the interim budget the medical colleges in Hingoli and Jalna were also announced along with other districts such as Dharashiv, Nashik, Sindhudurg, and Palghar. Most of these districts will soon have medical colleges with an intake capacity of 100 students and 430-bed hospitals.

Earlier this year, the former Union Health Minister Mansukh Mandaviya provided the State/UT-wise details of MBBS seats across the country. As per the data provided by the Health Ministry, Maharashtra has 68 medical colleges with 10845 MBBS and 6074 PG medical seats.

Also Read: 1,08,940 MBBS, 70,645 PG Medical Seats in India, Maximum Medical Colleges in Tamil Nadu, Karnataka offers most seats

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CDSCO Panel Approves Novartis Protocol Amendment Proposal To Study Ruxolitinib and Panobinostat

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major Novartis for the clinical trial protocol titled “Open Label, Multi-Center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies”.

This came after the firm presented protocol amendment version 05 dated 12.01.2024 protocol no.CINC424A2X01B. This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.

Ruxolitinib is a medication used to manage and treat myelofibrosis, polycythemia vera, and steroid-refractory acute graft-versus-host disease. It is in the Janus Kinase inhibitor class of medications. Ruxolitinib falls under the drug class known as Janus kinase inhibitors (JAK Inhibitors). It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.

Panobinostat is a potent inhibitor of histone deacetylase, which is responsible for the regulation of gene transcription, cellular differentiation, cell-cycle progression, and apoptosis. The inhibition of histone deacetylase prevents the deacetylation of histone and nonhistone proteins. Panobinostat is a chemotherapy medication that stops cancer cells from growing. It treats multiple myeloma. This is a rare type of blood cancer that affects many parts of your body.

At the SEC meeting for Oncology held on 5th and 6th June 2024, the expert panel reviewed protocol amendment version 05 dated 12.01.2024 protocol no.CINC424A2X01B presented by the drug major Novartis.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read:Zydus Life Science Gets CDSCO Panel Nod To Manufacture and Market Anti-cancer Drug Nelarabine

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Meerut Medical College employee accused of embezzling over Rs 12 lakh

Meerut: In a significant financial misconduct case, a clerk at SVBP Medical Hospital under LLRM Medical College in Meerut has been accused of siphoning off more than Rs 12 lakh in file charges.

The fraud, which affected around 34,285 patients who were admitted to the medical college hospital since 2020, has raised serious concerns.

The accused, a ward boy and clerk in the emergency ward, is at the centre of the investigation. According to Dr Dheeraj Balyan from LLRM Medical College, the accused allegedly manipulated the funds for patient file charges and is suspected of embezzling the funds.

Also read- KEM Hospital Employee Booked For Embezzling Rs 61.65 Lakh Via Forged Bills

In response to the allegations, the accused has been summoned to appear before the principal of LLRM Medical College, Meerut. As per a TOI news report, a senior LLRM official admitted loopholes were observed at the administration’s end.

Dr Balyan told the Daily, “Akhilesh Verma, a ward boy and clerk in the emergency ward, has allegedly siphoned off the money. Exact amount is yet to be determined. He is asked to appear before the principal.”

Medical Dialogues team had earlier reported a similar incident where a director of a private multispecialty hospital in Vineet Kunj on Kolar Road was allegedly duped of Rs 1.5 crore by an employee at his hospital.

According to the police, the accused, a 70-year-old manager at the hospital allegedly manipulated the hospital’s billing register and embezzled the salaries of the employees working in the hospital and the expenses incurred in the maintenance of the hospital.

The victim in this case was Dr Ranjit Chaudhary, the director of Arihant Kidney and Multispecialty Hospital in Vineet Kunj on Kolar Road. The complainant initiated the construction of the kidney hospital in the Kolar area in 2018.

Also Read: Telangana doctor duped of Rs 33 lakh in magical money doubling scheme

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FMGE June 2024 On July 6, Admit Card To Be Released On July 3: NBE issues notice for candidates, check details

New Delhi- The National Board of Examinations in Medical Sciences (NBEMS) through a notice has informed that the Foreign Medical Graduate Examination (FMGE) June 2024 admit card is going to be released on July 3, 2024. The test cities allotted to candidates have already been informed through emails.

Through the notice, NBE has advised all the applicants of FMGE June 2024 to check their applicant login accounts on the FMGE June 2024 index page on the official website of NBEMS once the admit cards go live.

Also Read: NBE gives Final opportunity for FMGE Qualified Candidates to Collect Passing Certificates, check deadline

Along with this, all the applicants of FMGE June 2024 should be cautioned of the following-

1 NBEMS does not send any email or SMS to candidates regarding securing good marks/merit positions in any of the exams conducted by NBEMS. Candidates are advised not to be allured or mislead by unscrupulous agents /touts making such false and bogus claims.

2 NBEMS does not make any phone calls to any candidate or issue any communication regarding any unfair assistance during the exam in any of the exams conducted by NBEMS or for any other such thing which is against the provisions of law.

Besides, candidates are advised to familiarise themselves with the location of the test centre and plan travel time accordingly as the test cities allotted to candidates have already been informed through emails. Candidates have to reach the test centres on or before the reporting time. They may note that late entry to the examination premises is not permitted under any circumstances. NBEMS shall not be responsible for any delayed arrival of the candidate in reaching the centre due to any reason.

NBEMS is going to conduct the FMGE June 2024 on 6th July 2024 where Part-I of the exam will start from 9 AM to 11:30 AM and Part II from 2 PM to 4:30 PM on a computer-based platform at 71 exam centres in 50 exam cities across the country. Therefore, the admit card will be issued on July 3, 2024, however, the candidates found ineligible before the conduct of the examination the admit card will not be issued to them.

Also Read: FMGE June 2024: NBE notifies on final opportunity to submit deficient documents

Meanwhile, candidates are required to bring 2 documents on the day of the FMGE June 2024 exam and anyone who fails to show the documents will not be allowed inside the exam centre. The documents are as follows-

1 Print out of admit card issued by NBEMS.

2 Government-issued photo identification proof in original & in hard copy

Apart from this, candidates are not allowed to take anything inside the examination centre under any circumstances.

At the same time, candidates can carry medicine or a medical assistance device at the exam centre, however, it is essential to carry supportive medical documents. In the absence of such documents, the candidate shall not be permitted to carry such devices/ prosthesis/ medicine etc. In addition, a PwD candidate can assist of scribe in writing the examination, however, it is required to seek prior approval of NBEMS by way of submitting a query at the NBEMS Communication Web Portal along with documents in support as per provisions of the RPwD Act, 2016. In the absence of prior approval of NBEMS, the candidate shall not be allowed to accompany a scribe with him/her inside the exam centre.

Any candidate found guilty of having adopted any unfair means/misconduct during FMGE JUNE 2024 is liable for criminal and/or academic penalty as per applicable provisions & guidelines.

To view the notice, click the link below

https://medicaldialogues.in/pdf_upload/nbems2024290232818jpg-242638.pdf

Also Read: FMGE June 2024 Final Edit Window open till June 10th, Details

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Third case of Brain-Eating Amoeba: 12-year-old Kozhikode boy tests positive

Kozhikode: Days after a 13-year-old girl from Kannur died from the amoebic meningoencephalitis, another case of the rare brain infection caused by a free-living amoeba found in contaminated waters has surfaced in Kerala’s Kozhikode district. 

A 12-year-old boy has been afflicted by amoebic meningoencephalitis, a rare brain infection caused by a free-living amoeba found in contaminated waters, in Kozhikode district of Kerala, according to sources in the private hospital where he is being treated.

This is the third case of a near fatal infection reported from the southern state since May.

According to a PTI report, the first one was of a five-year-old girl from Malappuram who died on May 21 and the second of a 13-year-old girl from Kannur who died on June 25. 

Also Read:Quinazolinone, derivatives effective against Brain-eating amoebae, finds study

The third case is of a 12-year-old boy from Kozhikode who was admitted in the Baby Memorial Hospital here on Monday.

One of the doctors treating him said that the infection was identified and the treatment commenced on the same day.

“We identified the infection in tests done at our labs and informed the DMO who took preventive measures by closing down access to the pond where the child had bathed,” the doctor said. 

The samples were then sent for testing to a lab in Puducherry from where the printed PCR report is awaited officially confirming the infection, he said.

“The disease has a mortality rate of 95-100 per cent. The boy continues to be in critical condition,” the doctor said.

He said that the hospital was able to quickly identify the infection and begin treatment as it was the third case of the disease and the protocols were already in place to deal with it.

According to medical experts, the infection is caused when free-living, non-parasitic amoebae bacteria enter the body through the nose from contaminated water.

The Health Department on Thursday had asked people to exercise caution against amoebic meningoencephalitis.

“Bathing in stagnant water and diving in water should be avoided as much as possible as this disease has been reported in Kerala. Water in theme parks and swimming pools should be properly chlorinated to ensure that it is clean,” it had said, news agency PTI reported.

Previously, the disease was reported in coastal Alappuzha district in 2023 and 2017. The primary symptoms include fever, headache, vomiting, and seizures

Also Read:Neurotrophic Keratopathy Mimicking Acanthamoeba Keratitis: AJO Case Report

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