Novel Combination Therapy Xanomeline-Trospium Promising for Treatment of Schizophrenia: JAMA

Researchers have found that the investigational combination of xanomeline-trospium (KarXT) is effective and well-tolerated in individuals with schizophrenia who are experiencing acute psychosis. The randomized controlled phase III EMERGENT-3 trial demonstrated that the combination therapy significantly reduced Positive and Negative Syndrome Scale (PANSS) total scores over five weeks compared to placebo, indicating its potential as an alternative treatment option. This study was published in the journal JAMA Psychiatry by Kaul and colleagues.

Schizophrenia is a chronic and severe mental disorder that affects how a person thinks, feels, and behaves. Traditional antipsychotic medications often target dopamine receptors, but the combination therapy of xanomeline-trospium represents a new approach that does not involve D2 dopamine receptor blocking activity.

The EMERGENT-3 trial was a randomized, double-blind, multicenter, placebo-controlled trial involving 256 participants aged 18 to 65 with a diagnosis of schizophrenia. Participants were assigned to either the xanomeline-trospium group (n=125) or the placebo group (n=131). The xanomeline-trospium group received varying doses of the combination therapy over the five-week treatment period, while the placebo group received a placebo.

The primary outcome was a change in PANSS total scores from baseline to week 5. Secondary endpoints included changes in PANSS positive and negative subscale scores.

The key findings of the study were:

  • Participants receiving xanomeline-trospium experienced a greater reduction in PANSS total scores compared to those on placebo (−20.6 vs −12.2).

  • The least squares mean difference was −8.4 (95% CI −12.4 to −4.3, P<0.001).

  • The Cohen d effect size was 0.60, indicating a moderate effect of the combination therapy.

  • The xanomeline-trospium group showed significant reduction in PANSS positive subscale score (−7.1 vs −3.6) at week 5 compared to placebo.

  • The combination therapy was well tolerated, with few serious treatment-emergent adverse events.

  • Discontinuation rates were similar between the therapy and placebo groups (6.4% vs 5.5%).

The findings suggest that the novel combination therapy xanomeline-trospium may offer a new treatment option for individuals with schizophrenia experiencing acute psychosis. The results are consistent with previous trials and support the potential for xanomeline-trospium to be the first non-dopamine medication with proven efficacy in treating acute episodes of schizophrenia.

Xanomeline-trospium demonstrates promise as a novel combination therapy for treating acute psychosis in individuals with schizophrenia. The therapy’s efficacy and tolerability make it a potential alternative to traditional antipsychotics. Further research is needed to evaluate the long-term durability of the therapy’s effect and safety.

Reference:

Kaul, I., Sawchak, S., Walling, D. P., Tamminga, C. A., Breier, A., Zhu, H., Miller, A. C., Paul, S. M., & Brannan, S. K. (2024). Efficacy and safety of xanomeline-trospium chloride in schizophrenia: A randomized clinical trial. JAMA Psychiatry (Chicago, Ill.). https://doi.org/10.1001/jamapsychiatry.2024.0785

Powered by WPeMatico

Wearable biosensor paired with AI may predict aggression among young psychiatric inpatients with autism: JAMA

Wearable biosensors paired with AI may predict aggression among young psychiatric inpatients with autism JAMA Network open

Aggressive behavior is a prevalent and challenging issue in individuals with autism. A study was done to investigate whether changes in peripheral physiology recorded by a wearable biosensor and machine learning can be used to predict imminent aggressive behavior before it occurs in inpatient youths with autism.

This noninterventional prognostic study used data collected from March 2019 to March 2020 from 4 primary care psychiatric inpatient hospitals. Enrolled participants were 86 psychiatric inpatients with confirmed diagnoses of autism exhibiting operationally defined self-injurious behavior, emotion dysregulation, or aggression toward others; 16 individuals were not included (18.6%) because they would not wear the biosensor (8 individuals) or were discharged before an observation could be made (8 individuals). Data were analyzed from March 2020 through October 2023.

Research staff performed live behavioral coding of aggressive behavior while inpatient study participants wore a commercially available biosensor that recorded peripheral physiological signals (cardiovascular activity, electrodermal activity, and motion). Logistic regression, support vector machines, neural networks, and domain adaptation were used to analyze time-series features extracted from biosensor data. Area under the receiver operating characteristic curve (AUROC) values were used to evaluate the performance of population- and person-dependent models.

Results

There were 70 study participants (mean [range; SD] age, 11.9 [5-19; 3.5] years; 62 males [88.6%]; 1 Asian [1.4%], 5 Black [7.1%], 1 Native Hawaiian or Other Pacific Islander [1.4%], and 63 White [90.0%]; 5 Hispanic [7.5%] and 62 non-Hispanic [92.5%] among 67 individuals with ethnicity data). Nearly half of the population (32 individuals [45.7%]) was minimally verbal, and 30 individuals (42.8%) had an intellectual disability. Participant length of inpatient hospital stay ranged from 8 to 201 days, and the mean (SD) length was 37.28 (33.95) days. A total of 429 naturalistic observational coding sessions were recorded, totaling 497 hours, wherein 6665 aggressive behaviors were documented, including self-injury (3983 behaviors [59.8%]), emotion dysregulation (2063 behaviors [31.0%]), and aggression toward others (619 behaviors [9.3%]). Logistic regression was the best-performing overall classifier across all experiments; for example, it predicted aggressive behavior 3 minutes before onset with a mean AUROC of 0.80 (95% CI, 0.79-0.81).

This study replicated and extended previous findings suggesting that machine learning analyses of preceding changes in peripheral physiology may be used to predict imminent aggressive behaviors before they occur in inpatient youths with autism. Further research will explore clinical implications and the potential for personalized interventions.

Reference:

Imbiriba T, Demirkaya A, Singh A, Erdogmus D, Goodwin MS. Wearable Biosensing to Predict Imminent Aggressive Behavior in Psychiatric Inpatient Youths With Autism. JAMA Netw Open. 2023;6(12):e2348898. doi:10.1001/jamanetworkopen.2023.48898

Keywords:

Wearable, biosensor, paired, AI, may, predict, aggression, among, young, psychiatric, inpatients, with, autism, JAMA Network open, Imbiriba T, Demirkaya A, Singh A, Erdogmus D, Goodwin MS.

Powered by WPeMatico

Higher vitamin C intake associated with reduced cancer risk in CKD patients, reveals study

A recent study explored the impact of vitamin intake on cancer risk among individuals with chronic kidney disease (CKD) and revealed promising results with vitamins C and E. The key findings of the study were published in the International Urology and Nephrology.

Chronic kidney disease affects kidney function over time and often limits the dietary choices of patients which in turn can impact nutrient intake, including vital vitamins. This study sought to identify whether specific vitamin intakes might be associated with reduced cancer mortality among this population.

This study was conducted using data from the National Health and Nutrition Examination Survey from 2007 to 2018 and included a total of 3,518 CKD patients with the analysis spanning from June to December 2023. The participants were divided into four groups based on their vitamin consumption levels that was determined through K-mean clustering. The mean age of the participants was approximately 61.8 years and they were followed for a median period of 7.3 years. During this time span, a total of 137 patients succumbed to cancer.

The findings found high intake of vitamin E was linked to a nearly 55% reduction in cancer mortality when compared to the individuals with the lowest intake (Hazard Ratio [HR] 0.45, 95% Confidence Interval [CI] 0.24-0.87, P=0.018). Also, a linear relationship between increasing vitamin E intake and decreasing cancer mortality was observed that suggests greater consumption of vitamin E could consistently benefit the CKD patients in terms of cancer risk.

A dietary pattern high in both vitamin C and vitamin K was also associated with a reduced risk of cancer death. The patients in the high C/K vitamin intake group underwent a 58% decrease in the risk of dying from cancer when compared to the individuals with a low vitamin intake (HR 0.42, 95% CI 0.20-0.88, P=0.022). These results underline the importance of dietary management in CKD with regard to vitamin supplementation. Overall, vitamins C and E were both known for their antioxidant properties that could play a crucial role in reducing the burden of cancer in CKD patients by suggesting a potentially pivotal area for dietary intervention.

Source:

Li, J., Liu, Z., Xie, X., Peng, L., Dai, H., Gao, C., Mao, W., Yuan, W., Zhao, X., Zhang, H., & Peng, F. (2024). Dietary vitamin intake and cancer risk in patients with chronic kidney disease: results from the National Health and Nutrition Examination Survey (2007–2018). In International Urology and Nephrology. Springer Science and Business Media LLC. https://doi.org/10.1007/s11255-024-04060-2

Powered by WPeMatico

Opioids during pregnancy not linked to substantially increased risk of psychiatric disorders in children: BMJ

Opioid use during pregnancy is not associated with a substantial increase in the risk of neuropsychiatric disorders such as ADHD in children, finds a large study from South Korea published by The BMJ today.

A slightly increased risk of neuropsychiatric disorders was found, but the researchers say this should not be considered clinically meaningful because it was limited to mothers exposed to more than one opioid prescription, high doses, and over longer time periods during pregnancy.

According to 2019 data from the Centers for Disease Control and Prevention, around 7% of women in the United States were prescribed opioids during pregnancy.

Previous studies have shown mixed findings on the association between opioid use in pregnancy and various health outcomes in offspring due to small sample sizes and short follow-up periods.

To address this knowledge gap, an international team of researchers set out to investigate the potential association between opioid exposure during pregnancy and risk of neuropsychiatric disorders in offspring.

Their findings are based on data from the National Health Insurance Service (NHIS) of South Korea for 3,128,571 infants born between 2010 and 2017 and 2,299,664 mothers (average age 32).

Mothers were grouped according to dose, duration, and frequency of opioid prescriptions during pregnancy and infants were followed up for an average of six years.

Factors including mother’s age at delivery, household income and pre-existing health conditions, and infant sex, birth weight and breastfeeding history were taken into account. A sibling comparison analysis was also carried out to account for genetics, lifestyle, and environmental influences.

Overall, 216,012 (7%) of the 3,128,571 infants were exposed to opioids during pregnancy (prenatal exposure).

A small increased risk of neuropsychiatric disorders was found among children exposed to prescription opioids during pregnancy compared with those not exposed, but the researchers interpret this as clinically insignificant.

And no significant association was noted in the sibling comparison group.

However, exposure to prescription opioids during the first trimester of pregnancy, at higher doses, and for 60 days or more were associated with a slightly increased risk of mood disorders, ADHD, and intellectual disability.

This is an observational study so no firm conclusions can be drawn about cause and effect, and although the researchers adjusted for a range of factors, they can’t rule out the possibility that others may have influenced their results, or that some misclassification of opioid use may have occurred.

Nevertheless, this was a large study based on high quality data and several statistical analyses were carried out to test the strength of the results, providing greater confidence in the conclusions.

As such, they conclude: “These results support cautious opioid prescribing for relief of pain during pregnancy, highlighting the importance of further research for more definitive guidelines.”

In a linked editorial, researchers agree that while short term use of lower dose prescription opioids after the first trimester appears relatively safe, caution is warranted when prescribing opioids for longer durations or at higher dosages.

This study “provides additional evidence to inform clinical decision making for women requiring pain management during pregnancy,” they write.

“Given the unique clinical value of opioids for managing severe pain, additional research is needed to fully characterize the degree of risk and thoroughly disentangle the association among pain, pain management, and various pregnancy outcomes,” they conclude.

Reference:

Kang J, Kim H J, Kim T, Lee H, Kim M, Lee S W et al. Prenatal opioid exposure and subsequent risk of neuropsychiatric disorders in children: nationwide birth cohort study in South Korea BMJ 2024; 385 :e077664 doi:10.1136/bmj-2023-077664.

Powered by WPeMatico

Biologics useful treatment option for patients with pityriasis rubra pilaris, finds research

Biologics are a treatment option for patients with pityriasis rubra pilaris suggests a new study published in the Cutaneous Medicine and Surgery.

A study was done to describe the published efficacy and adverse event rates associated with existing biologics for the treatment of pityriasis rubra pilaris (PRP). A literature review using the PubMed database (January 1990-July 2023) was conducted. Multiple search combinations were conducted using “pityriasis rubra pilaris” and various biologics as keywords to identify relevant articles. Inclusion criteria included all study types that were published within the past 30 years in English and mentioned at least one biologic and PRP. A preliminary search yielded a total of 499 results. After screening using inclusion and exclusion criteria, 77 relevant articles (69 case reports, 5 case series, 2 clinical trials, and 1 retrospective analysis) were analyzed. TNF-α inhibitors have been evaluated and are effective in treating PRP. However, recent treatment with anti-interleukin (IL)-17 and anti-IL-23 therapies such as ustekinumab, secukinumab, and ixekizumab are emerging as new treatment options with a mean improvement in PRP Area and Severity Index scores, change in severity of erythema, scaling, and thickness of PRP lesions. From initial clinical trials, secukinumab and ixekizumab are promising treatment options for achieving remission. This review compares the efficacy for numerous biologics and a discussion to guide clinicians on benefits and risks in choosing a biologic for PRP patients. Biologics may be a favourable treatment option leading to greater patient adherence due to reduced dosing frequencies, improvement in quality of life, and reduction in frequency and severity of flares.

Reference:

Chandy RJ, Chokshi A, Tan I, Feldman SR. Biologics for Treatment of Pityriasis Rubra Pilaris: A Literature Review. Journal of Cutaneous Medicine and Surgery. 2024;0(0). doi:10.1177/12034754241238735

Keywords:

Chandy RJ, Chokshi A, Tan I, Feldman SR. Biologics, Treatment, Pityriasis Rubra Pilaris, Journal of Cutaneous Medicine and Surgery.

Powered by WPeMatico

HC relief to NEET aspirant with Neurogenic Bladder disorder, allows bio-break, wearing adult diapers during exam, suggests measures for exam centres

Madras- Granting relief, the Madras High Court recently accepted the plea of ​​a 19-year-old NEET aspirant for a bio-break and wearing adult diapers and changing them when required during the NEET exam on May 5. Justice GR Swaminathan observed that any candidate who was not necessarily suffering from any disability set out under the 2016 act but otherwise had special requirements or had a biological condition was entitled to reasonable accommodation.

Justice GR Swaminathan passed the order after the aspirant produced a medical certificate from her doctor that currently, she is undergoing treatment for LETM/NMO/Spectrum Disorder/Neurogenic Bladder due to which she lacks control over urine and also needs to wear a diaper constantly, which also needs to be changed frequently.

The court also directed the examination authorities to ensure that all examination centres had suitable toilet facilities with water amenities and a minimum number of sanitary products so that the girls coming unprepared could use them. The court also suggested that the restrooms could be thoroughly inspected in advance and regularly thus limiting the frisking of candidates for a second time and thus, saving the candidates’ precious time.

Though the candidate requested the authorities to permit her to write the exam wearing the diaper and to change it in between depending on her condition, since there was no response, she approached the court.

Hearing the plea, Justice GR Swaminathan noted “The petitioner’s apprehension could not have been dismissed as misplaced or unfounded. NEET is held all over the country every year. We read that the mandatory frisking to which the candidates are subjected to sometimes taken to absurd limits. In Kerala, once a girl was asked to remove her innerwear. Girls in particular face the brunt”.

“All persons having disabilities have special needs. That does not mean the disabled as defined in the statute alone have special needs. Beneficial principles and doctrines have to be expansively construed and applied”, he further added.

The Court has also suggested that the toilets at the NEET centres be thoroughly inspected beforehand so that girls taking the exam do not have to undergo further frisking before they can use the toilet.

Justice Swaminathan also mentioned “Every examination centre must have suitable toilet facilities with water amenities. They must keep a minimum number of sanitary products near the toilets so that any girl who has come unprepared may use them. Girl candidates must be allowed the use of restrooms when required. The restrooms can be thoroughly inspected in advance and regularly so that there is virtually no need for frisking the candidates for the second time. This will save the candidates precious examination time. The authorities must spread awareness so that the candidates are not put to any stress at all”.

Meanwhile, highlighting the provisions of the Rights of Persons with Disabilities Act, 2016, the judge said that due to her biological condition, she needed a bio-break while writing the exam. If necessary facilities are not provided to the petitioner, she will not be able to appear in the examination and this will amount to discrimination which is prohibited by Article 14 of the Constitution.

On the other hand, NTA had agreed to the girl’s request and given and undertaken to issue appropriate instructions to the examiner. While pointing out NTA’s decision the judge recorded the stand and allowed the girl’s plea.

In the end, the judge concluded by saying “It would have been appropriate if the clause specifically permitted wearing of sanitary pads by the girl children”.

To vie the order, click on the link below:

Powered by WPeMatico

Justify Rationality of FDC Meropenem plus Sodium Carbonate plus Avibactam: CDSCO Panel Tells Akum Pharmaceutical

New Delhi: Reviewing the proposal presented by the drug major Akum Pharmaceutical, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the justification and rationality of the fixed-dose combination (FDC) antimicrobial drug Meropenem Trihydrate IP (Sterile) eq. to Anhydrous Meropenem 1000mg + Sodium Carbonate eq. to Sodium 90.2mg + Avibactam Sodium (Sterile) eq. to Avibactam 500mg injection.

This came after the firm presented the proposal before the committee regarding the fixed-dose combination (FDC) antimicrobial drug Meropenem Trihydrate IP (Sterile) eq. to Anhydrous Meropenem 1000mg + Sodium Carbonate eq. to Sodium 90.2mg + Avibactam Sodium (Sterile) eq. to Avibactam 500mg injection.

Meropenem is a carbapenem antibiotic used to treat a wide variety of infections in the body. Meropenem is a broad-spectrum carbapenem antibiotic.

Meropenem injection is used to treat infections caused by bacteria. It works by killing the bacteria or preventing their growth. This medicine will not work for colds, flu, or other virus infections. This medicine is to be given only by or under the direct supervision of your doctor.

Avibactam is a non-β-lactam β-lactamase inhibitor used in combination with ceftazidime for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital or ventilator-acquired pneumonia.

Avibactam has an unusual mechanism of action: it is a covalent inhibitor that acts via ring opening, but in contrast to other currently used β-lactamase inhibitors, this reaction is reversible. Here, we present a high-resolution structure of avibactam bound to a class C β-lactamase, AmpC, from P.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the proposal for the FDC antimicrobial drug Meropenem Trihydrate plus Anhydrous Meropenem plus Sodium Carbonate plus Avibactam Sodium injection.

After detailed deliberation, the committee recommended the following:

1. The firm should present the justification on rationality for combining this FDC and its significant benefit along with recent supporting documents/ literature.

2. Justification on dose titration with recent supporting documents/ literature.

3. International approval status.

4. Recent scientific literature available from peer-reviewed journals in support of combining the proposed FDC.

Accordingly, the expert panel suggested that the firm should submit the above data for further review by the committee.

Also Read: CDSCO approves Abbott’s proposal for Protocol Amendment of Triamcinolone Hexacetonide study

Powered by WPeMatico

Consumer Court relief to Gynaecologist held negligent for leaving mop inside body during Caesarean

Lucknow: Noting that in the absence of any evidence-based finding, the conclusion of Uttar Pradesh Medical Council (UPMC) and the erstwhile Medical Council of India (MCI), now National Medical Commission (NMC) cannot be sustained legally, the National Consumer Disputes Redressal Commission (NCDRC) has absolved a gynaecologist from charges of medical negligence. It was alleged that the doctor left behind a surgical mop inside the patient’s body during a C-section surgery.

Presiding over the case, Subhash Chandra, Presiding Member, and Dr Sadhna Shanker, Member clarified that the State Commission using a principle called “res ipsa loquitor” to support their stance is based on “assumption” as the patient had undergone previous surgeries, like an abortion and another cesarean section. So, it’s not clear if the mop was left during the surgery in question or one of the earlier surgeries.

The Apex Commission addressed two appeals filed by the doctor and the patient. The doctor challenged the State Commission’s order issued in 2021 regarding the medical negligence case while the patient moved NCDRC seeking enhancement of comepensation.

The case involved a gynaecologist, the appellant doctor, practising at Dr M. Khan Hospital in Bareilly, who performed a cesarean section on the respondent patient on November 1, 2010. After the operation, the patient and her child were discharged, but on February 16, 2011, she returned to the hospital complaining of abdominal pain, diagnosed as acute colitis. Despite conservative management, her symptoms persisted, leading her to seek further consultation with a gastroenterologist and eventually at the Sanjay Gandhi Post Graduate Institute (SGPGI), Lucknow. Ultrasound examinations revealed abnormalities in her uterus and cervix, prompting further investigations and procedures.

On June 23, 2011, a gauze (mop) soaked in fecal material was found and removed from her vagina. Due to complications, she underwent multiple surgeries, including a transverse loop colostomy.

The patient’s husband filed complaints and an FIR alleging medical negligence against the gynaecologist and the hospital. The Chief Medical Officer (CMO) constituted a medical board to investigate, which found inconclusive evidence due to discrepancies in the size and shape of the mop used in the hospital and the one found in the patient’s genitals. Another medical board, formed at the behest of the District Magistrate, similarly found no evidence of negligence.

Despite these findings, the patient filed a complaint with the UP Medical Council, resulting in the gynaecologist’s suspension for six months, starting from May 1, 2013. The doctor then challenged this decision through a writ petition, which was dismissed by the Allahabad High Court.

The patient (respondent) filed a complaint with the State Commission seeking several reliefs, including compensation for medical negligence, reimbursement of medical expenses, compensation for loss of income, and legal costs. The State Commission ruled in favor of the patient, directing the defendants (gynecologist, the hospital and others) to pay Rs 50 lakhs as compensation, along with interest, Rs 3,90,107.28 for medical expenses, Rs 84,000 for mental agony, and Rs 1 lakh as the cost of proceedings. The defendants were given 30 days to comply, failing which the interest rate would increase to 15% per annum. They were also directed to indemnify the insurance coverage. Both parties appealed to NCDRC against this order, with the appellant (gynecologist and others) seeking its dismissal and the respondent (patient/complainant) seeking an increase in compensation.

The doctor contested the impugned order on several grounds. Firstly, the counsel argued that the principle of res ipsa loquitur, which implies “the thing speaks for itself,” does not apply in this case. They asserted that the elements required for this maxim to be invoked, such as clear evidence of negligence, lack of evidence against the plaintiff, breach of duty of care, and significant injury to the plaintiff, are not met.

Secondly, it was contended that negligence must be established by demonstrating that the defendant acted negligently, ruling out the possibility of the plaintiff or a third party causing the injury, and that the negligence falls within the defendant’s duty of care towards the plaintiff. They argued that the size and shape of the surgical mop recovered from the respondent differ from those used by the doctor, as confirmed by the Enquiry Committee led by the Additional CMO. Additionally, the statement of the OT technician asserted that there was no discrepancy in the number of mops and instruments before and after the caesarean operation.

The counsel highlighted the inconclusive findings of the police investigation, which recorded the statement of Dr. Kapoor from SGPGI, Lucknow, stating that it was not possible to determine whether the mop recovered was left during the first or second caesarean section operation on the patient. Furthermore, the mop was not sent for histopathological examination but was incinerated due to being soaked in fecal matter.

It was contended that the presence of adhesions during surgery indicates inflammation in the area posterior to the uterus, making it feasible that the mop was left during a previous surgery. They suggested that the mop could have been left during an abortion prior to the first caesarean operation in November 2009, considering the patient’s medical history.

Further, the counsel criticized the patient for not cooperating with any of the inquiries ordered by the Additional CMO, the District Magistrate, and the UP Medical Council, and for failing to provide details regarding their past medical history. 

The counsel appearing for the doctor cited medical literature showing that foreign bodies can remain asymptomatic in the human body for an extended period, suggesting that the mop may have manifested symptoms later, as observed in this case.

The counsel further argued that the injury was caused by a third party, and thus, the principle of res ipsa loquitur should not have been invoked by the State Commission. It was contended that the State Commission erred in ignoring the categorical finding that the surgical mops recovered were of different sizes and shapes, as confirmed by the inquiries conducted by the CMO and at the direction of the District Magistrate. Additionally, they point out that the mop recovered from SGPGI, Lucknow, was incinerated, and the statement of the OT Assistant did not indicate any discrepancy in the number of mops used before and after the surgery. Furthermore, it was submitted that the State Commission failed to consider medical literature provided and that the awarded compensation lacked a basis, leading to unjust enrichment.

It was argued that the State Commission’s order relied on conjecture and surmise and the report of the UP Medical Council, which they believe does not qualify as an expert opinion. The appellant doctor cited previous Supreme Court judgments to support their contention that expert opinions must be supported by reasoning. They also challenged the finding that their failure to challenge the UPMC’s report amounted to an admission of negligence, as the suspension period was already over by the time the decision was communicated. The counsel argued that the compensation awarded without establishing deficiency in service was unjustified and arbitrary.

On the other hand, the patient challenged the impugned order for inadequately compensating her. The counsel appearing for the patient claimed that the State Commission overlooked the principle that relief for deficiency in service under Section 14 of the Act should include compensation for any loss or injury suffered due to negligence. The counsel cited Supreme Court judgments to support their argument that compensation should cover expenses already incurred, pain and suffering, lost wages, and future care. They also referenced specific cases where the Supreme Court enhanced compensation in matters involving medical negligence. Additionally, they contended that the doctor’s negligence resulted in medical issues that required them to travel for treatment, causing prolonged suffering and depriving them of caring for their newborn child.

The apex court noted the state commission’s observations which concluded that the doctor, as per the findings of the Medical Council of India, was guilty of negligence, deficiency in services, and professional misconduct. It noted that despite the doctor’s admission that they did not practice for six months as directed by the UP Medical Council, they still filed an appeal before the MCI now NMC, which was subsequently dismissed. The State Commission accepted the findings of the UP Medical Council, approved by the MCI, that the doctor was responsible for leaving the surgical mop in the complainant’s body. It dismissed the argument that the mop may have been left during a previous cesarean operation, as the patient did not experience any pain until after the second cesarean and continuously suffered thereafter.

Furthermore, the State Commission held the hospital negligent for lacking basic and emergency facilities and failing to provide proper care to the patient. It emphasized the duty of doctors to remain present with the patient until the operation is complete and highlights the hospital’s responsibility to uphold the standards of medical care. The State Commission applied the maxim res ipsa loquitur, indicating that the case clearly demonstrates medical negligence without exception. It concluded that the doctor’s  acceptance of the UP Medical Council’s report and the lack of proper facilities and supervision constitute admissions of negligence, leading to the complainant’s success in proving their case.

The finding of the State Commission read: “During the course of argument, the Counsel argued that the complainant was operated before one year and it may happen that this mop might be left at that time. If for the sake of argument, it is presumed that this mop was left during first caesarean, during second cesarean the concerned doctor was unable to detect it and if she detected it, she left it unattended. It is no argument because the complainant did not complain of any pain after the first cesarean and after the second cesarean she continuously suffered from pain and visited various doctors. It was the duty of the hospital to provide all the basic facilities and emergency facilities in case of any untoward happenings. It is the duty of the doctor that she should stay all the time opposite the bed of the patient unless and until the operation is over and the patient has been allowed to go to ICU or Ward. In this case the hospital is also negligent because they want to make money and they have forgotten their oath which was taken before entering into the medical profession. All the abovementioned facilities should be there and if anyone lacks, it will come under deficiency of service and negligence. This is a case where the maxim res ipsa loquitur is applicable in full strength and as per the various judgments of the Hon’ble courts it is clear that it comes under medical negligence without any exception. The guilt has already been admitted during the enquiry as opposite party accepted the enquiry report. So, the complainant has succeeded in proving his case.”

The Commission observed that the issue in the case involved was determining whether the doctor was negligent in medical treatment, whether the doctrine of res ipsa loquitur was correctly applied by the State Commission, and whether the patient  deserves higher compensation according to the principle of restitutio in integrum.

It mentioned that the law regarding medical negligence, as established by the Supreme Court in Jacob Mathew vs. State of Punjab & Anr., is based on the Bolam Test. It emphasizes that negligence must be judged based on the standard of care expected of a reasonable medical practitioner. The court highlighted that the failure to meet this standard, resulting in damage, constitutes negligence. Furthermore, the court clarified that the application of res ipsa loquitur, the principle that the thing speaks for itself, must be cautious in cases of professional negligence, particularly in the medical field. It stressed that adherence to established medical practices defines the standard of care, and negligence cannot be presumed solely based on unfavorable treatment outcomes.

In essence, the Supreme Court’s rulings emphasize the need to establish a breach of duty resulting in damage to prove medical negligence, with a clear understanding of the standard of care expected of medical professionals.

The case revolved around allegations of medical negligence against appellant no.1, a doctor (gynecologist) for leaving a mop of gauze in the abdomen of the patient during a caesarean operation. The mop was discovered through a sonography at SGPGI, Lucknow, prompted by the respondent’s complaints of persistent abdominal pain post-surgery. While reports from separate medical inquiries ordered by the district administration found inconclusive evidence linking the recovered mop to the one used in the hospital, the UP Medical Council concluded negligence, a decision upheld by the Medical Council of India.

The State Commission affirmed this conclusion. The UP Medical Council’s report highlighted the patient’s testimony and the presence of the mop laden with fecal matter, leading to the conclusion of negligence by the doctor.

The decision in this case hinged on the findings of both the Uttar Pradesh Medical Council and MCI, which concurred that the doctor was negligent in leaving the mop in the respondent’s abdomen during surgery. The Ethics Committee of the UPMC, after hearing testimonies and reviewing clinical records, upheld this decision, which was subsequently approved by the Executive Committee of the MCI. The State Commission upheld the medical negligence based on these findings. The doctor argued that the patient’s medical history and the OT Assistant’s testimony were overlooked, and the doctor did not fully accept the UPMC’s decision. Additionally, the timing of the MCI’s decision, just days before the appellant’s suspension ended, was highlighted.

The apex commission noted that while the Uttar Pradesh Medical Council and the MCI suspended the doctor’s license based on their Ethics Committees’ conclusions, these conclusions lacked sufficient reasoning to establish civil liability for medical negligence. The State Commission’s reliance on these reports and the principle of res ipsa loquitur was deemed unsubstantiated, especially given the absence of evidence linking the mop found in the patient’s abdomen to the appellant’s surgery. The patient had a history of previous surgeries, and no conclusive evidence tied the mop to the surgery in question. The Commission noted;

“We find that in this case the breach of duty resulting in medical negligence has not been categorically proven since neither the mop is available as evidence, nor its dimensions conform to the ones used in the appellant no. 2 hospital apart from the evidence of the OT Assistant not being controverted. Further, while the conduct of the appellant has been held deficient from an ethical point of view by the two professional bodies which considered the matter, their reports do not support the claim of the respondent for civil liability of medical negligence. The issue of criminal liability has not been raised since no mens rea has been alleged.

In order to establish deficiency in service, it is imperative that negligence be established. As held by the Hon’ble Supreme Court in Jacob Matthew (supra), “negligence becomes actionable on account of injury resulting from the act or omission amounting to negligence attributable to the person sued.”

The State Commission’s order in relying merely upon the reports of the UPMC and the MCI has not determined the above. The reliance on the principle of res ipsa loquitor in the present case by the State Commission is also based on the assumption that the mop extracted from the Pouch of Douglas of the respondent was due to the negligence of appellant no. 1 in leaving it in the abdomen during surgery.

As is evident from the records of this case, the respondent patient had admittedly undergone an earlier abortion and a caesarean section operation for the birth of another child. There is no evidence on record to establish whether the mop in question pertained to any of these surgeries or was due to negligence of the appellant doctor during the caesarean section operation conducted by her on 01.1.2010. No reasoning for the finding arrived at by the UP Medical Council or the Medical Council has been provided to bring out the basis for concluding the appellant liable for medical negligence. There is no evidence on record that has been relied upon to reach this conclusion. In the absence of any evidence based finding, the conclusion of these bodies cannot be sustained legally.”

As a result, the decision overturned the State Commission’s order, absolving the doctor of liability and dismissing the patient’s appeal for compensation enhancement. It held;

“In view of the discussion above, we find that liability of appellants no. 1 and 2 as determined by the State Commission cannot be sustained. We therefore set aside the impugned order of the State Commission….In view of the conclusion above, FA 60 of 2022 filed by the respondent patient seeking enhancement of compensation fails.”

To view the original order, click on the link below:

Powered by WPeMatico

Medical Waste Discharge of Government Rajaji Hospital in Vaigai River: HC issues notice to Tamil Nadu Govt

Madurai: Taking up a case involving a serious environmental concern in Madurai, the Madras High Court has instructed relevant authorities to
submit their responses after a public interest litigation (PIL) petition
alleged that untreated liquid medical waste from the Government Rajaji Hospital
(GRH) was being discharged into the Vaigai River.

A Division Bench of Justices G. R. Swaminathan and B. Pugalendhi issued
notices on the petition filed by activist Vaigai Rajan of Madurai. Vaigai Rajan’s petition seeks an order to halt the discharge of medical
waste into the Vaigai River, specifically in the Alwarpuram area. Rajan claims
that GRH generates significant amounts of medical waste daily, which is
directly channelled into the Vaigai River without proper purification, reports The Hindu.

Moreover, Rajan alleged that Madurai Corporation
has been discharging untreated sewage from a pumping station on the GRH campus
into the river for many years. Despite the presence of a sewage treatment plant
on the GRH premises, it is reportedly not functioning properly due to
insufficient power supply. The petitioner asserts that the situation is
hazardous, rendering the water unfit for consumption and posing a risk of
groundwater contamination.

Mr Rajan pointed out that the Centre for Urban Water Resources (CURE)
of DHAN Foundation published an article in 2021 on “Water Watch Quality Matters
– Urban Vaigai under Isolation” and pointed out that stopping the discharge of sewage and solid waste into the river is the only way to bar the contamination of Vaigai
river with pollutants and harmful toxins. 

However, the activist discovered that the sewage treatment plant at GRH has been
inoperative due to a lack of a dedicated electricity connection, which would
require a deposit of ₹33 lakh, reports the Daily. Additionally, the nearby sewage treatment plant
at Alwarpuram is also facing possible demolition due to the construction of the
proposed Goripalayam flyover. The demolition could exacerbate the discharge of
untreated sewage into the Vaigai River.

Mr Rajan previously approached authorities with his concerns,
urging them to address the issue of untreated sewage and medical waste being
dumped into the river. However, he claimed that no concrete action had been
taken to remedy the situation. The court adjourned the hearing of the case
until the first week of June, allowing time for the authorities to respond and
take necessary measures to address the concerns raised by the petition. This
case highlights the pressing need for improved waste management practices and
environmental protection in the region. 

Also Read: Tamil Nadu: All Pharmacists Association stages protest, demanding 1200 vacancies to be filled

Powered by WPeMatico

PM Modi no longer visible on CoWin certificates for COVID-19 vaccination, Health Ministry responds

New Delhi: Amid the controversy related to the potential side effects of Covishield vaccination, the photo of Prime Minister Narendra Modi who prominently featured in the CoWIN certificates for COVID-19 vaccinations over the past few years has been removed.

The certificate issued by the Ministry of Health and Family Welfare now contains only the words of the Prime Minister ‘Together, India will defeat Covid-19’ and not his photo. Earlier, along with this caption, the Prime Minister’s picture was also in the certificate.

The removal of the Prime Minister’s image comes in the backdrop of the controversy regarding the potential side effects of Covishield vaccination. AstraZeneca, the manufacturer of the vaccine admitted to the UK High Court that potential side effects like Thrombosis with Thrombocytopenia Syndrome (TTS), a rare condition involving blood clotting may occur in those who have been injected with the CoviShield vaccine.

Also read- AstraZeneca Admits ‘Very Rare’ Side Effect Of COVID Vaccine In UK Court

Many people in the United Kingdom who have experienced health problems after receiving the vaccine have taken legal action. In the UK High Court, 51 cases have been filed by individuals claiming that the vaccine caused deaths and serious health problems.

According to an article published in The Daily Telegraph, a British newspaper, AstraZeneca acknowledged in a legal document filed with the High Court in London in February that their COVID-19 vaccine, developed in collaboration with the University of Oxford, could potentially lead to TTS in extremely uncommon instances. This admission was made concerning a group action lawsuit involving 51 claimants.

Worried about the potential cause of the vaccinations, many Indians started inspecting their vaccination certificates and discovered that the recently downloaded vaccination certificates no longer show the image of Narendra Modi. 

Following this, the citizens took to microblogging platform X (formerly Twitter) and pointed out the issue. Social media user Sandeep Manudhane also confirmed the disappearance of Modi’s photo by cross-checking the certificates. 

Sharing a picture of the Covid-19 vaccine certificate, he wrote in a post “Modi ji no more visible on Covid Vaccine certificates. Just downloaded to check – yes, his pic is gone.”

Another social media user, Santosh Iyer, also said the same, “Yes, you are correct. I checked and find that Modi’s photo is no longer visible on the covid vaccination certificates ! Ha!Ha!Ha!

“Yes, I just checked and PM Modi’s photo has disappeared and there is only a QR code instead of his photo,” wrote Irfan Ali, another user who identified himself as a Congress functionary.

Responding to the sudden change and the disappearance of Modi’s image in the certificate, officials from the health department told ThePrint on Tuesday that this was due to the Model Code of Conduct (MCC) being in place for the ongoing Lok Sabha polls.

According to the PTI report, this is not the first instance of Modi’s photo being excluded from vaccination certificates, with the most recent occurrence in 2022 when Modi’s photo was removed from vaccination certificates distributed in five states – Uttar Pradesh, Uttarakhand, Punjab, Manipur, and Goa at the direction of the Election Commission of India (ECI) ahead of assembly elections in those states.

Medical Dialogues team in 2021 had reported that the Election Commission asked the health ministry to follow the provisions of the poll code in letter and spirit against the backdrop of a complaint by the Trinamool Congress that the picture of the prime minister on COVID-19 vaccination certificates violates the model code. 

A source said the health ministry may have to use filters so that the picture of the prime minister is not printed on certificates given to those who take the COVID-19 vaccine in poll-bound West Bengal, Tamil Nadu, Assam, Kerala and Puducherry.

Also read- PM Modi Pic On Vaccine Certificates: Election Commission Asks Health Ministry To Follow Poll Code Provisions

Powered by WPeMatico