Is intratympanic oxytocin effective for treating cisplatin induced ototoxicity? Study sheds light

Turkey: In a groundbreaking experimental study, researchers have compared the effectiveness of intratympanic oxytocin and dexamethasone in combating cisplatin-induced ototoxicity, a common side effect of cisplatin chemotherapy.

The study, published in the Indian Journal of Otolaryngology and Head & Neck Surgery, revealed that intratympanic oxytocin may be an option that can be used in the treatment, however, it is not as effective as dexamethasone in preventing cisplatin ototoxicity.

Cisplatin is a potent chemotherapy drug widely used in treating various cancers. However, its clinical utility is limited by ototoxicity, characterized by irreversible damage to the inner ear structures, leading to hearing loss and balance disorders. Traditional treatments for cisplatin-induced ototoxicity, such as systemic steroids, have shown limited efficacy and significant side effects.

Although widely used, there is still no valid treatment for ototoxicity caused by the antineoplastic drug cisplatin. In the study, Burak Mustafa Taş, Kırıkkale University School of Medicine, Kırıkkale, Turkey, and colleagues aimed to investigate the efficacy of intratympanic resveratrol and intratympanic dexamethasone treatment in cisplatin-induced cytotoxicity. They also compared intratympanic atosiban (oxytocin antagonist) and oxytocin in cisplatin ototoxicity.

The study separated 30 rats (60 ears) into five groups. Cisplatin, dexamethasone, oxytocin, atosiban, and 0.9% NaCl were administered intraperitoneally to all groups separately. On all the groups, Auditory Brainstem Response and Distortion Product Otoacoustic Emission tests were performed before and 72 hours after the procedure.

Following were the study’s key findings;

  • Pre-treatment values were higher than post-treatment values in all groups.
  • There was no significant prolongation of the post-treatment Auditory Brainstem Response I-IV interval in the oxytocin and dexamethasone groups.
  • There was no significant decrease in the frequencies of 2832 and 4004 after treatment in the oxytocin and dexamethasone group compared to pre-treatment in Distortion Product Otoacoustic Emission.

These findings suggest that intratympanic oxytocin holds promise as a novel therapeutic approach for the prevention of cisplatin-induced ototoxicity. Oxytocin, known for its role in social bonding and stress regulation, may exert protective effects on the inner ear through its anti-inflammatory and antioxidant properties.

The investigators believe that further research is warranted to elucidate the underlying mechanisms of oxytocin-mediated cochlear protection and to optimize dosing regimens for clinical translation. If validated in human studies, intratympanic oxytocin could offer a safer and more effective alternative to traditional treatments for cisplatin-induced ototoxicity, potentially improving the quality of life for cancer patients undergoing chemotherapy.

Reference:

Taş, B.M., Özel, G., Azman, M. et al. Comparison of Intratympanic Oxytocin and Dexamethasone in Cisplatin Ototoxicity: An Experimental Study. Indian J Otolaryngol Head Neck Surg (2024). https://doi.org/10.1007/s12070-024-04701-z

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Ibuprofen sodium dihydrate as effective as combo with Acetaminophen for Endodontic Pain Relief: Study

A recent study found that the combination of acetaminophen (APAP) and a new formulation of ibuprofen, also called as ibuprofen sodium dihydrate (ISD), does not improve pain relief for patients with severe dental pain linked to apical periodontitis when compared to ISD alone. The critical findings were published in the Journal of Endodontics.

This double-blind, randomized study included a total of 64 adult patients presenting at an emergency dental service with acute symptoms of irreversible pulpitis or necrosis, as well as symptomatic apical periodontitis associated with a severe form of dental pain. Each participant was assigned to receive a single dose of either 768 mg of ISD combined with 1000 mg of APAP or 768 mg of ISD alone.

The study utilized the Heft-Parker Visual Analogue Scale (VAS) to evaluate the effectiveness of these treatments. Assessments were recorded every 15 minutes over a four-hour period following medication. This research also tracked the time to the first sign of pain relief, time to meaningful pain relief and time to achieve 50% pain reduction.

The findings revealed that both treatment groups underwent a significant reduction in pain within the first two hours following medication administration. However, after 120 minutes, the decrease in pain levels plateaued, with no substantial differences noted between the two groups in terms of VAS scores at any time point or in the recorded times to pain relief milestones.

The results of this study are particularly significant as they challenge the common practice of combining ibuprofen with acetaminophen for more effective pain management. ISD which is a newer formulation of ibuprofen is designed to be absorbed more quickly could potentially offer faster pain relief. This study suggests that ISD alone is equally effective as when combined with acetaminophen for treating severe dental pain associated with apical periodontitis.

The benefits of these findings are considerable for clinical practices in settings where rapid pain relief is paramount. The clinicians may consider simplifying their pain management strategies for endodontic conditions by potentially reducing medication intake for patients without compromising the efficacy. Further research may explore different combinations or dosages, but this study adds pivotal knowledge to the field of pain management in dental care by suggesting that simpler may be just as effective.

Reference:

Palya, M., Chevere, J. M., Drum, M., Fowler, S., Nusstein, J., Reader, A., & Ni, A. (2024). Pain Reduction of Ibuprofen Sodium Dihydrate Alone and in Combination with Acetaminophen in an Untreated Endodontic Pain Model: A Randomized, Double-blind Investigation. In Journal of Endodontics. Elsevier BV. https://doi.org/10.1016/j.joen.2024.04.005

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PAD useful screening test for dysphagia in patients with stroke: Study

South Korea: In a critical advancement for stroke care, a recent study has validated the Practical Assessment of Dysphagia (PAD) test as a reliable tool for evaluating swallowing difficulties in stroke patients. The findings, published in the Dysphagia journal, underscore the importance of accurate and efficient dysphagia assessment in improving patient outcomes post-stroke.

The study showed the emergence of the PAD test as a robust screening tool for post-stroke dysphagia. Researchers found significant inter- & intra-rater reliabilities (Kappa coefficient), high internal consistency, and strong correlations between PAD scores & videofluoroscopic swallowing study results. High specificity and sensitivity further solidified its status as a go-to screening tool.

As stroke remains a leading cause of disability worldwide, the validation of tools like the PADT represents a significant stride toward enhancing stroke care and rehabilitation efforts. By empowering healthcare providers with reliable and valid assessment tools, the research contributes to optimizing patient outcomes and reducing the burden of post-stroke complications.

Dysphagia, or difficulty swallowing, is a common complication following stroke, posing significant risks such as aspiration pneumonia and malnutrition. The PADT, a bedside screening tool designed to assess swallowing function, has gained traction in clinical practice due to its simplicity and efficiency. However, until now, its reliability and validity in the context of stroke patients have remained relatively unexplored.

Hyo Jong Kim, Chungbuk National University College of Medicine, Seowon-gu, Cheongju, Republic of Korea, and colleagues aimed to investigate the validity and reliability of the Practical Assessment of Dysphagia test as a quantitative and organ-specific test for stroke patients.

For this purpose, the researchers used PAD test data from 109 patients with stroke. Cronbach’s α value was used to analyze the internal consistency of the PAD. Based on the correlation between PAD and the videofluoroscopic swallowing study (VFSS), concurrent validity was evaluated. The diagnostic accuracy of the PAD test in stroke patients was measured using the area under the receiver operating characteristic (ROC) curve.

The key findings include:

  • Intra- and inter-rater reliabilities (Intra-class Correlation Coefficient (ICC) = 0.98 and 0.99, respectively) were significant for the total PAD score.
  • The functional dysphagia scale (FDS) score and penetration-aspiration score (PAS) correlated significantly with PAD.

The results of the ROC curve analysis with various cut-off points showed high sensitivity and specificity of the PAD test. The PAD has high validity and reliability. Therefore, it is a useful screening test for dysphagia in patients with stroke.

In conclusion, the study validates the Practical Assessment of Dysphagia Test as a reliable and valid tool for assessing swallowing difficulties in stroke patients. With its implications for clinical practice, the PADT stands poised to improve dysphagia management and enhance the quality of care for stroke survivors.

Reference:

Kim, H.T., Min, HJ. & Kim, H.J. Reliability and Validity Analyses of the Practical Assessment of Dysphagia Test in Stroke. Dysphagia (2024). https://doi.org/10.1007/s00455-024-10708-z

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Case Report Highlights Rare Association: Progesterone-Only Contraceptive may Induce Ischemic Colitis

USA: In a noteworthy development in the field of gastroenterology, a recently published case report has shed light on a rare but potentially significant association between the use of progesterone-only contraceptives and the development of ischemic colitis, a condition characterized by inflammation and injury to the colon due to reduced blood flow.

In the case study published in ACG Case Reports Journal, the researchers have reported a unique case of biopsy-confirmed ischemic colitis (IC) in a previously healthy 30-year-old woman who presented with abdominal pain and bloody diarrhea two months after initiation of progesterone-only oral contraceptive.

The case report underscores the importance of vigilance in recognizing and managing adverse effects of commonly used medications.

The case concerns a 30-year-old white woman with no significant medical history presented to the emergency department with a 3-week history of worsening crampy abdominal pain, bloody diarrhea, and nausea. She denied any history of alcohol usage or smoking. Her vital signs on admission were stable. Abdominal examination was positive for normal bowel sounds and diffuse tenderness to palpation but was negative for guarding or rigidity. Her only medication was progesterone-only contraceptives for the past two months.

She responded to conservative management with antiemetics, and intravenous fluids, and was asked to discontinue progesterone-only contraceptive pill on discharge. Her symptoms improved over 2 weeks after discharge while off of her progesterone-only contraceptive. On a 3-month outpatient visit, she denies any recurrence of symptoms.

Progesterone is a hormone crucial for maintaining pregnancy and is known to exert vasoconstrictive effects on blood vessels, which can compromise blood flow to various organs, including the colon. While such an association had been documented previously in a handful of case reports and small-scale studies, the present case provided further evidence to support this intriguing link.

Ischemic colitis occurs with a temporary lack of adequate blood supply to the intestines, specifically in vulnerable areas such as the sigmoid colon and splenic flexure, which lack sufficient collateral blood vessels. Although primarily seen in older individuals with atherosclerotic risk factors, IC can also be triggered by hormonal contraceptives in young women. Although estrogen-containing oral contraceptives are known to increase thromboembolic risk, the impact of progesterone is not well understood.

In conclusion, the case is the first biopsy-proven case of IC resulting from a progesterone-only contraceptive pill. Despite the widespread progesterone-only contraceptive use, IC occurrence within this patient population remains unrecognized.

Although potential patient-related variables may contribute to disease onset in the absence of a known hypercoagulable state, the precise cause remains elusive.

“There is a need for further studies to better comprehend the impact of progesterone on coagulation, particularly concerning the mesenteric vasculature,” the researchers wrote.

Reference:

Rajamanuri, Medha MD1; Garg, Meher AS2; Siddiqui, Harris MD1; Pannala, Sreeram MD3. Progesterone-Only Contraceptive-Induced Ischemic Colitis. ACG Case Reports Journal 11(4):p e01313, April 2024. | DOI: 10.14309/crj.0000000000001313

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People with opioid use disorder less likely to receive palliative care at end of life

Compared with people without opioid use disorder, those with opioid use disorder were less likely to receive palliative care in clinics and in their homes, and were dying at younger ages of causes other than opioid use, according to new research published in CMAJ (Canadian Medical Association Journal).

“The majority of conversations about the opioid crisis focus on the high number of opioid toxicity deaths. The unfortunate reality is that people with opioid use disorder are dying young from other causes as well,” says author Dr. Jenny Lau, medical director of the Harold and Shirley Lederman Palliative Care Centre at Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario. “If we can improve our understanding of this population and the health care that they receive at the end of their lives, we can identify opportunities to intervene and improve their quality of life.”

With the ongoing opioid crisis, the number of people with opioid use disorder is increasing. Opioid use disorder can be a chronic, life-limiting illness causing substantial impairment and distress. As the population with opioid use disorder ages, more people will need access to palliative care at the end of their lives. This study describes the characteristics of people with opioid use disorder at the end of their lives and examines whether they receive palliative care.

In this large study that included information from ICES on 679 840 deaths, 11 200 of the deceased (1.6%) had opioid use disorder. People with opioid use disorder died at younger ages than those without opioid use disorder (50 yr v. 78 yr) and were more likely to live in marginalized neighbourhoods. Compared with people without opioid use disorder, people with opioid use disorder were 16% less likely to receive palliative care. This finding is most likely related to the high number of people with opioid use disorder who die suddenly from drug poisonings. The most common reasons why physicians provided palliative care for people with opioid use disorder were cancer, liver cirrhosis, and sepsis.

“Although most people in Canada want to die at home, people with opioid use disorder can have limited social supports, limited finances and unstable housing, which may lead to challenges accessing palliative care in the community and challenges for health care providers to deliver this care,” says coauthor Dr. Sarina Isenberg, chair in mixed methods palliative care research at Bruyère Research Institute, and adjunct scientist, ICES, Ottawa, Ontario. “Our findings highlight the importance of health care providers receiving training in both palliative care and addictions medicine to better support patients with opioid use disorder as they near the end of life.”

Reference:

Jenny Lau, Mary M. Scott, Karl Everett, Tara Gomes, Peter Tanuseputro, Sheila Jennings, Rebecca Bagnarol, Camilla Zimmermann and Sarina R. Isenberg, Association between opioid use disorder and palliative care: a cohort study using linked health administrative data in Ontario, Canada, CMAJ, DOI: https://doi.org/10.1503/cmaj.231419.

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Progress in Kidney Transplants: Therapeutic Hypothermia Emerges as a Solution for Delayed Graft Function

In a comprehensive multicenter randomized clinical trial, researchers have explored the effectiveness of therapeutic hypothermia in preventing delayed graft function in kidney transplants from low-risk, non-pumped donors after brain death. The study, spanning from August 10, 2017, to May 21, 2020, across four Organ Procurement Organizations in the United States, aimed to address a crucial question in transplantation medicine. The study’s findings indicate that, in low-risk, non-pumped kidneys from brain-dead donors, therapeutic hypothermia does not appear to significantly prevent delayed graft function in kidney transplant recipients.

Also Read: New study identifies five ferroptosis-related genes which may be a novel therapeutic target for focal segmental glomerulosclerosis

The study results were published in the journal JAMA Network Open.

The occurrence of delayed graft function in recipients of kidney transplants is linked to heightened financial expenses and additional burdens on patients. Notably, in donors exhibiting a high Kidney Donor Profile Index, whose kidneys do not undergo machine perfusion, therapeutic hypothermia has demonstrated its efficacy in providing a protective advantage against the development of delayed graft function. The primary objective was to determine whether maintaining donors at a lower temperature (34.0-35.0 °C) through therapeutic hypothermia was superior to normothermia (36.5-37.5 °C) in preventing delayed graft function.

This prospective, multicenter, randomized clinical trial included brain-dead kidney donors deemed low risk and not requiring machine perfusion per Organ Procurement Organization protocol. A total of 509 low-risk brain-dead kidney donors were enrolled, with 245 allocated to the normothermia group and 236 to the hypothermia group. The final analysis encompassed 934 transplanted kidneys. The donors were randomly assigned to either the hypothermia or normothermia group, and the study outcomes were evaluated following the intent-to-treat principle. The primary outcome under scrutiny was the occurrence of delayed graft function in kidney recipients, defined by the necessity for dialysis within the first week post-transplant.

Results:

  • A total of 934 kidneys were transplanted from 481 donors, with no significant differences observed in donor characteristics between the two groups.
  • Both the normothermia and hypothermia groups exhibited a similar incidence of delayed graft function, with rates of 18% and 17%, respectively.
  • The adjusted odds ratio, calculated at 0.92 (95% CI, 0.64-1.33; P = .66), indicated no statistically significant difference between the two groups in preventing delayed graft function.
  • Donor characteristics, including age, creatinine level, Kidney Donor Profile Index, and cold ischemia time, were found to be comparable between the normothermia and hypothermia groups.
Also Read: Acetazolamide ups rate of successful decongestion in acute decompensated heart failure, regardless of renal function: ADVOR trial

This groundbreaking study challenges the prevailing notion about the efficacy of therapeutic hypothermia in preventing delayed graft function in kidney transplant recipients from low-risk, non-pumped donors. The findings, while unexpected, provide critical insights that may reshape transplantation protocols. Continued research in this domain is essential to refine our understanding and further enhance outcomes in kidney transplantation.

Further reading: Patel MS, Salcedo-Betancourt JD, Saunders C, Broglio K, Malinoski D, Niemann CU. Therapeutic Hypothermia in Low-Risk Nonpumped Brain-Dead Kidney Donors: A Randomized Clinical Trial. JAMA Netw Open. 2024;7(2):e2353785. doi:10.1001/jamanetworkopen.2023.53785

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Children with asthma exposed to indoor pest allergens may face respiratory issues: Study

USA: A longitudinal study has revealed that indoor allergen exposure to pests like mice and cockroaches (but not dogs and cats) is linked with the occurrence of upper respiratory infections (URIs) and associated pulmonary outcomes in children with asthma.

“Mouse allergen concentration (OR 1.58) and cockroach allergen concentration (OR 1.79) was associated with URI with reduced lung function in 90 mostly Black kids sensitized to allergens,” Darlene Bhavnani, PhD, MPH, of Dell Medical School at the University of Texas at Austin reported during the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

The researchers also observed associations between these allergens and symptomatic URI, but these were not statistically significant. Findings also revealed an association between mouse and cockroach allergen concentrations and URI with pulmonary eosinophilic inflammation. However, cat and dog allergen concentrations were not associated with URI outcomes.

Previous research has shown that Black children more often report URIs compared with white children with asthma. Similar disparities have also been observed for food allergies. It is suggested that certain environmental allergen/irritant exposures are more common in disadvantaged communities of colour and may lead to differences in susceptibility to URI.

The research team used longitudinal data collected from sensitized children in the Environmental Control as Add-on Therapy for Childhood Asthma study. The study included 90 participants: 60% were male, 92% were Black, and 92% had public health insurance.

Allergen concentrations were measured in the home air samples (mouse) and settled dust (cat, cockroach, and dog) taken at baseline, 3, and 6 months. At clinic visits that occurred every two months from baseline to 6 months, patients were assessed with nasal mucus samples and spirometry, which were tested for respiratory syncytial virus, rhinovirus, coronavirus, influenza, parainfluenza, adenovirus, and human metapneumovirus.

Reduced lung function was defined as a per cent predicted forced expiratory volume (FEV1) less than 80%, and pulmonary eosinophilic inflammation was defined as a fractional exhaled nitric oxide (FENO) of 35 ppb or more. Odds ratios were adjusted for sex, age, season, month of study, health insurance type, and household size.

The study led to the following findings:

  • 90 participants with 118 observations were included; 27% were positive for URI.
  • Mouse allergen concentration was associated with symptomatic URI (OR51.24), URI+reduced lung function (OR51.58), and URI+pulmonary eosinophilic inflammation (OR51.42).
  • Cockroach allergen concentration was associated with symptomatic URI (OR51.30) and URI+reduced lung function (OR51.79).
  • There were no observations of URI+pulmonary eosinophilic inflammation among children sensitized to cockroach allergen.
  • Cat and dog allergen concentrations were not associated with URI outcomes.

“Mouse and cockroach, but not dog and cat, allergen exposure may predispose sensitized children with asthma to URIs and associated pulmonary outcomes,” the researchers wrote.

Low allergen concentrations and their study’s moderate sample size may have limited their ability to detect associations, the researchers noted. Furthermore, data were collected from a low-income and mostly Black population from a single inner-city setting, which may limit the findings’ generalizability.

“Further studies including multiethnic and multiracial patients are needed to address the impacts of real-world disparities on patients with asthma,” they concluded.

Reference:

Bhavnani D, et al “Indoor allergen exposure and its influence on upper respiratory infections and pulmonary outcomes among children with asthma” AAAAI 2024; Abstract L20.

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Video-assisted hand therapy effective after thumb arthritis surgery, reveals study

For patients undergoing carpometacarpal (CMC) joint surgery for treatment of thumb osteoarthritis, the use of online video instruction for postoperative hand therapy is associated with outcomes similar to in-person therapy visits – while substantially reducing travel time and distance, reports a clinical trial in The Journal of Bone & Joint Surgery. The journal is published in the Lippincott portfolio in partnership with Wolters Kluwer.

Video-administered hand therapy provides an “efficient and effective” alternative to in-person therapy after CMC arthroplasty, according to the new research by Peter J. Apel, MD, PhD, and colleagues of Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke.

Potential benefits of ‘video-only’ hand therapy after CMC surgery

Thumb CMC arthroplasty is a common surgical procedure for patients with painful osteoarthritis of the thumb. Although the benefits of hand therapy remain open to debate, most hand surgeons prescribe in-person therapy visits for patients undergoing CMC arthroplasty.

“While supervised in-person therapy may help to enhance postoperative hand function for daily activities, it can be burdensome to complete, especially for patients in rural or remote areas,” the researchers write. Asynchronous or “video-only” physical therapy is being explored as an alternative to in-person visits in a wide range of medical settings, including other orthopaedic surgery procedures.

Dr. Apel and colleagues designed a randomized trial evaluating hand therapy visits in 58 patients undergoing CMC arthroplasty. One group was assigned to video-only therapy, consisting of online videos demonstrating hand therapy exercises to be performed at home. Patients in the comparison group received an average of five in-person visits with a hand therapist.

The two approaches yielded similar significant improvement, as measured with use of patient-reported ratings of hand function after 12 weeks. Objective measures of pinch strength and grip strength were also comparable between groups. All outcomes remained similar at one-year postoperatively.

Video-only may offer a ‘more patient-driven approach’ to hand rehabilitation

A geospatial analysis suggested that video-only therapy reduced travel distance by an average of 278 miles and travel time by five hours – even more for patients living in sparsely populated areas. On a nationwide basis, switching from in-person visits to video-only hand therapy could save over 7 million miles of patient travel per year, the researchers estimated.

Patients were enthusiastic about video-only hand therapy, with six potential participants dropping out of the study on learning that they had been assigned to the in-person control group. Two patients initially assigned to the video intervention were switched to in-person visits.

The authors acknowledge some study limitations, including a lack of data on whether or how patients used the videos. The researchers also note the potential for selection bias, as the study excluded patients who lacked home internet access or were not comfortable using the video technology.

“This trial yields evidence that a more patient-driven approach with provision of videos is an acceptable alternative to traditional in-person therapy after thumb CMC arthroplasty and has the added benefit of reducing the potential travel burden for patients,” Dr Apel and coauthors conclude. They add that video-only therapy may offer “an efficient and effective method of delivering education and care with flexible scheduling and self-pacing.”

Reference:

Barrett PC, Hackley DT, Yu-Shan AA, Shumate TG, Larson KG, Deneault CR, Bravo CJ, Peterman NJ, Apel PJ. Provision of a Home-Based Video-Assisted Therapy Program Is Noninferior to In-Person Hand Therapy After Thumb Carpometacarpal Arthroplasty. J Bone Joint Surg Am. 2024 Apr 17;106(8):674-680. doi: 10.2106/JBJS.23.00597. 

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Non-payment of stipend, Lack of seats, 3-year internship rule: Doctors meet NMC officials to raise issues of FMGs

New Delhi: Doctors representing foreign medical graduates (FMGs) recently met the National Medical Commission (NMC) officials to discuss various issues faced by medical graduates from abroad. These issues include the limited number of available internship seats for the FMGs, the issue of non-payment of stipend to the FMG Interns and the opposition against the 3-year internship rule.

Sharing about the meeting with NMC, the Federation of Resident Doctors Association (FORDA) mentioned on X (formerly Twitter), “On a war footing now, a delegation representing #FMG interests met with officials at @NMC_IND today. Key points raised: • #Stipend for interns (currently none) •Absorption of students into various teaching and non-teaching hospitals of states. (Currently there are waiting lists for starting internship!) • Rethinking the merits and demerits of 3 year internship for a special batch of students. Hoping for a positive response from the authorities. #FMG have suffered and faced enormous challenges & discrimination. Some humanitarian approach is need of the hour.”

Commenting on the matter, the General Secretary of FORDA, Dr. Sarvesh Pandey informed Medical Dialogues that the officials have given positive responses regarding the issues faced by the FMGs.

Allow FMG-Internship at Non-Teaching Hospitals: 

The FMG representatives referred to the limited number of seats available for the Foreign Medical Graduates (FMGs) to pursue the mandatory internship. They urged the authorities to allow the FMGs to undergo internships at various teaching and non-teaching hospitals of States.

Commenting on the matter, Dr. Pandey told Medical Dialogues, “Previously, it used to be easier for foreign medical graduates to get into internship programme. However, as per the NMC guidelines, FMGs can do their internship only in government hospitals. Due to this, the foreign medical graduates have to wait for months to get into an internship programme even after clearing FMGE. So, we have urged the officials to allow internship even in the institutes where the DNB programmes are conducted.”

Recently, the Delhi Medical Council (DMC) also wrote to the Apex Medical Commission seeking a validation of FMG internship in Non-Teaching Hospitals.

Medical Dialogues had last year reported that around 2,000 FMG doctors were facing problems in getting enrolled into an internship programme. In the case of Rajasthan alone, only around 30 percent of the total students, who cleared the mandatory FMGE test in January secured a seat for Internship. Earlier, Rajasthan Medical Council only held counselling for filling only 399 seats while the state almost had approximately 2,000 FMG internship seats. 966 of the 1,365 exam-qualified candidates were still waiting for an internship seat.

Also Read: Allow Internships at Non-Teaching Hospitals: FMGs Urge NMC

Last year, offering one-time relaxation to the FMGs who were facing difficulties to join the mandatory internship programme in India due to the limited number of seats in the medical colleges, NMC allowed them to get enrolled at the non-teaching hospitals for this purpose.

Stipend for FMG Interns: 

The FMG representatives also raised the issue of stipend for FMG interns before the NMC officials. Recently, while considering the issue of non-payment of stipend to the Foreign Medical Graduates (FMGs) interns, the Supreme Court also said that the FMGs cannot be treated differently and should be paid stipends during their internship like their counterparts who have done MBBS from the Indian medical colleges.

However, Dr. Sarvesh Pandey said, “Despite the Supreme Court order and NMC guidelines, the FMGs do not get stipend during their internship. Several Government medical colleges ask the medical graduates from abroad to submit affidavit stating that they do not require stipend during the internship period and FMGs only get internship at such colleges under this condition. The representatives have requested the NMC to take steps so that the students are not pressurised to submit such affidavits for getting enrolled to the internship programme. They have also requested the authorities to give them stipend during the internship period.”

Also Read: Supreme Court relief: FMGs to now get stipend during internship as Indian MBBS interns

Opposition against 3-year Internship Rule: 

Another issue that the FMG representatives discussed with the NMC officials was the 3-year internship rule. Last year on 22.11.2023, addressing several issues concerning the FMGs, NMC had mentioned that medical students abroad, who had a break in their Final year and who returned to India due to the COVID pandemic or war and completed their course online such students “be allowed to continue to complete their two years before permanent registration given by the State Medical Council.”

NMC had also addressed the issues of FMGs who had a break in their Penultimate year of study and mentioned that “Existing FMGs, if any, already performing internship at present, may be allowed to continue with one year of internship. They may subsequently do one year clinical clerkship and one year internship. (Thus a total of three (3) years, before obtaining Permanent Registration from concerned SMC).”

Again on December 07, 2023, NMC released another Public Notice addressing such FMGs who returned to India in their Penultimate year, it mentioned, “Existing FMGs undergoing internship be allowed to continue to complete their three (3) years before permanent registration given by the State Medical Council.”

However, the medical graduates from abroad have been protesting against this extended period of internship arguing that these additional years of training is resulting in delays in achieving their academic goals and also creating financial burdens on their families.

“Why do the students need to undergo an internship for three years? We have requested the officials to remove this rule at the earliest,” Dr. Pandey told Medical Dialogues.

Also Read: Reconsider 3-year Internship Rule for FMGs: Doctors Urge Health Minister, NMC

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AstraZeneca Gets CDCSO Panel Nod to Import, market Eculizumab to treat Paroxysmal Nocturnal Hemoglobinuria

New Delhi: Noting that there is an unmet medical need in India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major AstraZeneca to import and market Eculizumab Concentrate for solution for infusion 300 mg for the treatment of patients with Paroxysmal nocturnal hemoglobinuria (PNH) subject to the condition that the firm should conduct Active Postmarketing surveillance (PMS) study.

This came after AstraZeneca Pharma presented the proposal for a grant of permission to import and market Eculizumab concentrate for solution for infusion 300 mg for the indication “the treatment of patients with Paroxysmal nocturnal hemoglobinuria (PNH)” along with a request for local clinical trial waiver.
The committee noted that the drug falls under the category of orphan drug and there is an unmet need in India. The drug is approved in the US and other countries.

Eculizumab is a long-acting humanized monoclonal antibody targeted against complement C5. It inhibits the cleavage of C5 into C5a and C5b and hence inhibits deployment of the terminal complement system including the formation of MAC.

Eculizumab injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body).

At the recent SEC meeting for Haematology held on 18th April 2024, the expert panel reviewed the proposal for a grant of permission to import and market Eculizumab concentrate for solution for infusion 300 mg for the indication “the treatment of patients with Paroxysmal nocturnal hemoglobinuria (PNH)” along with a request for local clinical trial waiver.
After detailed deliberation, the committee recommended a grant of permission to import and market the drug for indication i.e., “the treatment of patients with Paroxysmal nocturnal hemoglobinuria (PNH)” subject to the firm’s condition to conduct an Active PMS study.
Accordingly, the expert panel suggested that the firm should submit the Active PMS study protocol to CDSCO within 03 months of Marketing Authorization for review by the committee

Also Read:Serum Institute of India’s TB Detection tool rdESAT, rCFP-10 (Cy-Tb) use granted for 1 year age and above: CDSCO panel

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