Berberine could treat eczema-exacerbated staph infections, suggests study

Atlanta: Eczema, a skin inflammatory disease that causes dry, itchy and inflamed skin, affects millions worldwide.

Eczema is associated with an altered skin microbiome and higher colonization by Staphylococcus aureus. The study, led at New York Medical by postdoctoral fellow Anish R. Maskey, Ph.D., focuses on the natural compound berberine and its impact on eczema exacerbated by S. aureus.

The findings, presented at ASM Microbe, shed light on berberine’s ability to inhibit S. aureus colonization and alleviate eczema symptoms without adverse effects.

Current treatments often fall short—topical antibiotics can give temporary relief, but risk development of antibiotic resistance, and steroid use can potentially result in topical steroid withdrawal (TSW) syndrome. This study makes significant strides toward more effective eczema management using berberine.

The research team conducted comprehensive analyses, including whole genome sequencing of isolated S. aureus strains from eczema patients. The results revealed resistance genes and toxin-encoding genes, underscoring the urgency for alternative treatments. Berberine showed anti-inflammatory effects and inhibited mast cell degranulation, a key mechanism in eczema progression, suggesting its potential as a therapeutic agent. Mechanistic insights uncovered berberine’s ability to suppress genes associated with inflammatory pathways, and computational modeling identified key targets in the PI3K/AKT pathways.

“Berberine may be a valuable natural product for treatment of multi-drug resistant S. aureus-exacerbated eczema due to its antibacterial and anti-inflammatory [effects] and inhibition of mast cell degranulation,” Maskey said.

Funding from The Lie and Artati Family Fund and the Study of Integrative Medicine Fund supported this research.

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FDA approves new inhaled nonsteroidal nebulizer therapy ensifentrine for COPD

The US Food and Drug Administration (FDA) has approved ensifentrine an inhaled nonsteroidal nebulizer therapy for the treatment of patients with chronic obstructive pulmonary disease (COPD).

Ensifentrine is a dual inhibitor of phosphodiesterase 3 and 4 (PDE3; PDE4) pathways and is first treatment with a novel mechanism of action to be approved for COPD in the last decade.

Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.

Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

“The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms.”

Michael Wells, MD, Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama Birmingham, commented: “In my experience, despite maintenance therapy, most patients report grappling with daily symptoms, including breathlessness and persistent coughing. COPD has a significant impact on both mortality and morbidity in the US, and until today, innovation in inhaled treatment modalities has been limited to combinations of existing treatment classes for over two decades. Ohtuvayre, as a first-in-class PDE3 and PDE4 inhibitor, offers a needed, unique approach and is an important advance in the treatment of COPD.”

The US approval of Ohtuvayre was based on extensive data including the Phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre was well-tolerated in a broad population of subjects with moderate to severe COPD.

The Company is fully staffed to launch and expects Ohtuvayre to be available in the third quarter 2024 through an exclusive network of accredited specialty pharmacies.

About Ohtuvayre (ensifentrine)

Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD. Ensifentrine has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases.

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AIIMS Jodhpur ‘MBBS’ student appeared as proxy in NEET at Bihar centre, allowed to leave after written apology

Patna: In a shocking revelation in the NEET paper leak controversy, a 3rd-year MBBS student of AIIMS Jodhpur who was paid to be a proxy for a NEET-UG examinee got caught during biometric attendance at a centre in Bihar’s Muzaffarpur minutes before the May 5 test, but was allegedly allowed to go after submitting a written apology to the authorities.

According to a recent TOI report, new findings in the NEET case revealed that a third-year student from All India Institute of Medical Sciences (AIIMS)-Jodhpur was caught during biometric attendance at the examination centre in DAV School, Malighat, Bihar, minutes before the NEET-UG test on May 5 for allegedly appearing in place of a NEET aspirant. The examinee’s admit card featured a picture of the third-year MBBS student.

As per the TOI news report, the student confessed to impersonating the son of Dr. Pandey who owns a hospital in UP’s Prayagraj in exchange for Rs 4 lakh but was allegedly allowed to leave after submitting a written apology to the authorities.

In his apology letter, the accused student said “I come from a poor family. I was promised Rs 4 lakh, which is why I agreed to write the exam on someone else’s behalf.” Further, he said that he met Dr Pandey, who allegedly wanted a proxy for his son, in Kota, Rajasthan.

Also read- SN Medical College MBBS Student Appears As Proxy Candidate In NEET 2024 For Brother, Both Arrested

The accused student who went to the examination centre as a proxy for the said doctor’s son carried an admit card that featured the NEET aspirant’s picture. Meanwhile, since the incident, the accused AIIMS student has been absent from college.

The incident came to light when station house officer (SHO) Ram Krishna Paramhans Kumar received this information from an undisclosed source and registered an FIR at Mithanpura police station in Muzaffarpur accordingly on the same day. Both the student and Dr Pandey have been named in the FIR.

As per the daily, the breach at the examination centre in DAV School, Malighat, was never officially reported to the police and the authorities only made the accused student write an apology letter. 

Police quoted an official of the exam centre as saying that the young man had been asked to wait outside after he wrote an apology while the authorities decided what to do next. He allegedly sneaked out and couldn’t be traced.

ASP Awadhesh Dixit of Muzaffarpur told TOI, “The centre was under the scanner for not reporting the crime immediately. The school management was apparently reluctant to pursue the case, fearing damage to the centre’s reputation.” 

“Separate teams have been sent to Prayagraj, Barmer and Jodhpur to locate the accused. Neither of them was found at their respective homes or workplaces. The student who allegedly took money to act as a proxy for an examinee hasn’t attended classes at AIIMS-Jodhpur since May 2,” said SHO Paramhans Kumar.

Also read- Medical Student Found Running Proxy Practice For Doctor, Both Arrested

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Increasing Myopia Rates Linked to Anxiety and Mood Disorders in Adolescents: Study

Myopia is a rapidly growing global health concern which is predicted to impact half of the world’s population by 2050. This new research published in the Eye journal highlighted the significant impact this condition may have on adolescents in concern to their mental health. The study involved a large sample of Israeli adolescents aged 16 to 20 years which revealed a worrying connection between myopia and increased rates of anxiety and mood disorders.

This study analyzed data from nearly 9,00,000 adolescents who were undergoing evaluations before their mandatory military service from 2011 to 2022. These evaluations included sociodemographic information, medical histories, physical exams and precise measurements of eye refraction and visual acuity. 

Myopia was categorized into three levels based on the severity of vision impairment as mild, moderate and severe. Diagnoses of anxiety and mood disorders were confirmed by psychiatric consultants and classified according to the ICD-10 criteria. The socioeconomic status was determined by the place of residence of the adolescents at the time of examination.

Out of the 8,91,501 adolescents studied, 31.3% had myopia (19.3% mild, 9.6% moderate and 2.5% severe). Anxiety was diagnosed in 1.0% of the adolescents, while 0.5% were diagnosed with mood disorders. The prevalence of these mental health issues was markedly higher among the participants with myopia when compared to the participants without the condition. Also, 1.2% of myopic adolescents underwent anxiety when compared to the 0.9% of their non-myopic peers, and 0.6% had mood disorders when compared to 0.4% of the adolescents without myopia.

The severity of myopia also correlated with the prevalence of these conditions. The anxiety prevalence increased from 1.1% in the participants with mild myopia to 1.6% in the participants with severe myopia. Mood disorders rose from 0.5% in mild cases to 0.7% in severe cases. The logistic regression models indicated a dose-response relationship which showed the odds of having anxiety or mood disorders increased with the severity of myopia. This trend persisted even after adjusting for sociodemographic factors, visual acuity and other health conditions.

The study illuminates a crucial need to address the broader implications of myopia beyond vision correction. The increased odds of anxiety and mood disorders among adolescents with myopia highlight the psychosocial challenges associated with this condition. These findings suggest that integrated psychological support should be considered as part of comprehensive myopia management strategies. Early identification and intervention are highly eventful to reduce both the physical and mental health impacts of myopia.

Source:

Nitzan, I., Shmueli, O., & Safir, M. (2024). Association of myopia with anxiety and mood disorders in adolescents. In Eye. Springer Science and Business Media LLC. https://doi.org/10.1038/s41433-024-03170-6

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No Medical Negligence! Doctor only performed Excisional Biopsy to confirm cancer: NCDRC grants Rs 75 lakh relief to doctor

New Delhi: Reiterating the Supreme Court’s observation that every death occurring in a hospital does not necessarily amount to medical negligence, the National Consumer Disputes Redressal Commission (NCDRC) recently exonerated a doctor, accused of operating on a cancer patient without obtaining a Biopsy report. The bench noted that the doctor had performed only an Excisional Biopsy to confirm cancer, which is a prescribed method to diagnose Cancer, and it does not come within the purview of surgery.

While considering the matter, the Apex Consumer Court relied on the Supreme Court order in the case of Devarakonda Suryasesha Mani v Care Hospital, Institute of Medical Sciences, where the Apex Court had held that “Every death in an institutionalized environment of a hospital does not necessarily amount to medical negligence on a hypothetical assumption of lack of due medical care.”

Relying on the Supreme Court’s order, the consumer court bench exonerated the doctor and noted, “Considering the aforesaid discussions, there is no evidence on record to suggest any negligence or deficiency in service on the part of OP-1 Doctor in the treatment of the deceased.”

The history of the case goes back to 2015 when the complainant’s wife (deceased) consulted the treating doctor at his Nursing Home & Maternity centre with the complaint of stiffness and pain in her left breast. Her Thyroid tests for T3, T4, T5, and TSH were conducted and she was admitted on 10.12.2015. A tumour operation was performed on her left breast, during which the portion of the breast containing the tumour was removed. Thereafter, the tumour was sent for a biopsy test.

It was alleged that the doctor did not conduct a biopsy test before the operation and instead of improving, the deceased’s condition worsened after the surgery, with increased pain in her breast and waist, and her overall condition deteriorated. It was further claimed that the doctor had suggested conducting another operation.

Later, the biopsy report confirmed that the patient had cancer. However, the doctor allegedly advised the complainant not to inform the patient about the cancer immediately and suggested conducting another operation to remove the tumour.

However, by 07.01.2016, the patient’s pain had intensified, affecting her ability to stand and sit. Following this, on 02.02.2016, the patient was referred to another Hospital in Raipur, where she underwent various tests, including echocardiography, serology, biochemistry, haematology, and thyroid panel tests. A sample for the BFC test was sent to Mumbai. Further, the patient underwent an MRI test and was admitted to the second hospital. She underwent radiation therapy and was discharged.

The doctors recommended chemotherapy over surgery, as the initial operation without a biopsy had aggravated her condition. To save her life, she sought treatment from a Mumbai-based doctor and was admitted to another hospital, where she underwent continuous chemotherapy. 

As per the complainant, the initial negligence of the treating doctor in the surgery caused substantial physical and mental suffering. He argued that if the doctor had initially conducted a biopsy, the patient would not have faced such severe issues. The complainant further contended that not being a cancer specialist, the treating doctor should have referred her to a higher cancer hospital after conducting the biopsy. Filing the consumer complaint, the complainant demanded compensation of Rs 75,10,000 for medical expenses, mental agony, financial losses, and litigation costs.

On the other hand, the doctor submitted that initially the patient had symptoms of stiffness and pain in her left breast, and a tumour was detected during the preliminary examination.

Given this finding, an excisional biopsy was performed to remove the tumour, which was sent to Dr. Hussain, a pathologist in Raipur, for a histopathological test. This was to aid in her further treatment after receiving the biopsy report.

Consequently, the patient was admitted to the hospital for the excisional biopsy and was discharged. The report confirmed that she had breast cancer. When she complained of waist pain, she was appropriately referred to an Orthopaedic and her biopsy report’s confirmation of breast cancer was promptly communicated to her relatives and the doctor advised them not to inform the deceased immediately to prevent distress.

He submitted that the family was advised to take the patient to a cancer specialist in Raipur and he referred her to Sanjeevani Cancer Hospital at Raipur, where Dr. Memon confirmed the cancer diagnosis and noted that it had spread to the bone.

The treating doctor contended that the excisional biopsy was crucial in diagnosing the cancer as without this procedure, the presence of breast cancer would not be confirmed. He emphasized that he provided high-standard, quality services and promptly referred her to the appropriate cancer treatment centre after the biopsy confirmed the diagnosis. Therefore, the doctor denied any medical negligence on his part in the treatment of the patient.

While considering the matter, the State Commission, Chhattisgarh opined that the complainants failed to prove the allegations of medical negligence. Therefore, the Commission dismissed the complaint.

Challenging the order, the complainants approached the Apex Consumer Court. The NCDRC noted that as per the record, the doctor did not perform any surgery on the deceased patient. He only conducted a procedure for taking out a sample for biopsy purposes. 

At this outset, the top consumer court observed,

  “Therefore, OP-1 had performed only Excisional Biopsy to confirm cancer, which is a prescribed method to diagnose Cancer. The Complainants failed to reasonably establish that the surgery by OP-1 was without obtaining Biopsy Report. Whereas, OP-1 had done only Excisional Biopsy of the deceased, which does not come within purview of surgery. In any case, before conducting the said Excisional Biopsy, OP-1 obtained Consent Letter from her and Complainant No.1 on 10.12.2015. It is also part of the OT Notes for Breast Mass Excision dated 10.12.2015 that the Lump was separated from skin and breast and the same was sent for Histopathological test. There is also no expert opinion obtained from the competent Medical Board.”

The NCDRC bench referred to the Supreme Court orders in the case of Chanda Rani Akhouri (Supra), Dr. Laxman Balkrishan Joshi Vs. Dr. Trimbak Bapu Godbole and Anr., and Jacob Mathew v. State of Punjab to discuss what constitutes medical negligence and also the doctor’s duties to the patients.

Further, the Apex Consumer Court referred to the top court order in the case of Devarakonda Suryasesha Mani v Care Hospital, Institute of Medical Sciences, where the Apex Court had observed that ‘every death in an institutionalized environment of a hospital does not necessarily amount to medical negligence on a hypothetical assumption of lack of due medical care.’

Relying on this order, the Commission dismissed the complaint and held that there was no evidence on record to suggest any negligence or deficiency in service on the part of the treating doctor in the treatment of the deceased patient. With this observation, the NCDRC bench denied interfering with the findings of the State Commission.

To read the order, click on the link below:

https://medicaldialogues.in/pdf_upload/ncdrc-no-medical-negligence-242461.pdf

Also Read: No Medical Negligence: Consumer Court Junks Complaint Against Hospital, doctor for allegedly Conducting Total Laparoscopic Hysterectomy sans Consent

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Zydus Life science’s anticancer drug Pertuzumab Gets CDSCO Panel Nod for Additional Indication of Early breast cancer

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved Zydus Life Science’s Pertuzumab 30 mg/mL concentrate solution for infusion for the additional indication of early breast cancer.

However, this approval is subject to the condition that the firm conduct a Phase IV study of the anticancer drug Pertuzumab.

This came after Zydus Life Sciences presented the proposal for approval of additional indications of early breast cancer for the approved similar biologic Pertuzumab 30 mg/mL concentrate solution for infusion (rDNA origin) by way of extrapolation with a waiver of a local clinical trial.

Pertuzumab is an antineoplastic agent used in the treatment of HER2-positive metastatic breast cancer in combination with other antineoplastic agents.

Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). It consists of two heavy chains and two light chains that have 448 and 214 residues, respectively.

Human epidermal growth factor receptor-2 (HER2) is a tyrosine kinase receptor that plays an integral role in cell proliferation, differentiation, and survival. HER2 becomes active following dimerization with another HER2 receptor, another member of the HER protein family (e.g., HER3), or with a ligand; this dimer then phosphorylates and activates numerous intracellular signaling proteins, initiating signal transduction via pathways that include the Ras/mitogen-activated protein kinase pathway, the phosphatidylinositol 3′ kinase (PI3K)/Akt pathway, and then the Janus kinases/signal transducer and activator transcription pathway. HER2 is also a known oncogene; it is overexpressed or gene-amplified (i.e., HER2-positive) in approximately 20% of breast cancers, and these cancers carry a generally poorer prognosis than HER2-negative breast cancers.

Pertuzumab targets the extracellular dimerization domain (subdomain II) of HER2, thereby inhibiting ligand-initiated intracellular signaling via the MAP kinase and PI3K pathways. Inhibition of these pathways results in inhibition of cell growth and the initiation of apoptosis, respectively. Pertuzumab also appears to mediate antibody-dependent cell-mediated cytotoxicity.

At the recent SEC meeting for oncology held on June 5 and 6, 2024, the expert panel reviewed the proposal for approval of additional indications of early breast cancer for the approved similar biologic Pertuzumab 30 mg/mL concentrate solution for infusion (rDNA origin) by way of extrapolation with a waiver of a local clinical trial.

After detailed deliberation, the committee recommended the approval of an additional indication by way of extrapolation with a local clinical trial waiver, with the condition of conducting a Phase IV study in the proposed indication.
Accordingly, the expert panel suggested to the firm that the protocol to conduct the Phase IV study be submitted to CDSCO within three months of the grant of permission for the proposed additional indication.

Also Read:Submit safety data of Rotavirus vaccine in 1 to 2 years age group: CDSCO panel Tells Bharat Biotech on Oral Rotavirus Vaccine

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Magic mushrooms are the most-used psychedelic drug

Psilocybin mushrooms are the psychedelic substance most often used in the U.S., with its popularity outpacing other psychedelic drugs such as MDMA (known as ecstasy), according to a new RAND report.

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Diagnostic stewardship approach to C. diff reduces unnecessary testing

A new study published today in the American Journal of Infection Control (AJIC) describes the outcome of a new approach to testing for Clostridioides difficile (C. diff), guided by the principles of diagnostic stewardship. At Memorial Health care System in Hollywood, Fla., revised rules for when C. diff tests could be ordered helped to reduce inappropriate testing by 20%, which in turn can help rein in the overtreatment of patients.

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Use of glucose monitors by people not living with diabetes needs more regulation

A new narrative review led by researchers at UCL and Birmingham Children’s Hospital has found there is a lack of evidence to demonstrate the effective use of continuous glucose monitors (CGMs) in people not living with diabetes (PNLD).

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New study shows alcohol rehabilitation and abstinence reduce the risk of alcohol-associated cancers

A new study conducted by the Centre for Addiction and Mental Health (CAMH), Bordeaux University Hospital, France, and the World Health Organization (WHO) has found that individuals with alcohol dependence who undergo rehabilitation or maintain abstinence experience significantly lower risks of developing alcohol-associated cancers.

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