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Rahway: Merck, known as MSD outside of the United States and Canada, has received the approval from the U.S. Food and Drug Administration (FDA) for WELIREG (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).
Pheochromocytoma and paraganglioma are rare tumors that come from the same tissue, but pheochromocytoma form in the adrenal gland and paraganglioma form outside the adrenal gland. These tumors can be caused by certain genetic syndromes or mutations. The approval is based on data from the single-arm LITESPARK-015 clinical trial, where the primary endpoint was objective response rate (ORR).
“PPGL, sometimes referred to as pheo para, is a rare condition affecting up to 2,000 people each year in the United States. Patients with these tumors, which arise from the adrenal glands and the extra-adrenal paraganglia, may require specialized care due to their complexity and rare nature, often posing significant challenges for both diagnosis and treatment,” said Dr. Camilo Jimenez, professor, department of endocrine neoplasia and hormonal disorders, The University of Texas MD Anderson Cancer Center. “This approval, which is based on objective response rate data from the LITESPARK-015 trial, introduces belzutifan as the only approved and available non-surgical option for locally advanced, unresectable, or metastatic PPGL and could represent a change to the treatment paradigm for eligible patients.”
“For patients with advanced PPGL, there has been a lack of approved systemic treatment options available to help manage their disease, underscoring the importance of this approval in the U.S.,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “This approval marks the third indication for WELIREG in the U.S. and demonstrates our company’s commitment to providing innovative cancer therapies for patients in need, including those with rare diseases.”
“The WELIREG label contains a boxed warning that exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective. WELIREG can cause severe anemia that can require a blood transfusion. Monitor for anemia before initiation of and periodically throughout treatment with WELIREG. WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization. Monitor oxygen saturation before initiation of and periodically throughout treatment with WELIREG,” the Company stated in a release.
LITESPARK-015 is an open-label, multicohort Phase 2 trial (ClinicalTrials.gov, NCT04924075) evaluating the efficacy and safety of WELIREG monotherapy. The study enrolled 72 patients in a single cohort (Cohort A1) who had measurable disease verified by blinded independent central review (BICR) per RECIST v1.1, documented histopathological diagnosis of PPGL, locally advanced or metastatic disease that was not amenable to surgery or curative treatment, and adequately controlled blood pressure (defined as BP <150/90 mm Hg, <135/85 mm Hg for adolescents) with no change in antihypertensive medications for patients with concomitant hypertension for at least two weeks prior to start of study treatment. Patients with carcinomatous meningitis were excluded. Patients received WELIREG at a dose of 120 mg once daily until disease progression or unacceptable toxicity.
The major efficacy outcome measure for the treatment of advanced PPGL was ORR measured by BICR using RECIST v1.1. Additional efficacy outcome measures included duration of response and time to response.
WELIREG (belzutifan) 40 mg tablets, indicated for oral use in the U.S. for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.
It is also indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) with a clear cell component following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
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Velagapudi: Y. Satya Kumar Yadav, Minister for Health, Medical Education, and Family Welfare, strongly condemned recent reports of corruption involving District Medical Officers, calling for swift and decisive corrective action.
Speaking at a review meeting held at the Secretariat on Tuesday, May 13, the Minister expressed disappointment over the performance of certain District Medical and Health Officers (DMHOs) and District Health Services Coordinators (DCHSs).
The meeting focused on the implementation of various district-level health initiatives. According to The Hindu, during the review, the Minister praised Krishna district for leading in performance, followed by Vizianagaram and Prakasam. However, he noted with concern that Anantapur and other Rayalaseema districts were underperforming, both in Primary and Urban Primary Health Centres, as well as in Government Secondary Hospitals.
Mr. Yadav stressed the urgent need to enhance health services in these lagging regions. He also addressed serious concerns regarding alleged bribery in administrative appointments. The Minister revealed that some officers were reportedly soliciting money in exchange for job placements, which he condemned unequivocally.
To counter this, he proposed that public notices be issued in newspapers affirming that all selections are based solely on merit, cautioning candidates not to pay bribes. He further recommended that junior-level officials be transferred every three years to prevent misuse of power, and that DMHO performance reviews be conducted biannually to ensure accountability, reports the Daily. The Minister also instructed that all district-level officers must conduct routine visits to Government Secondary Hospitals under their purview to monitor service delivery and uphold healthcare standards.
Medical dialogues had earlier reported that six government doctors in the state were under scrutiny after Health Minister Satya Kumar Yadav accused them of corruption, absenteeism, dereliction of duty and issuing illegal disability certificates. The accusations are based on findings from multiple investigation reports highlighting their misconduct.
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An Instagram post claims that homemade drink made with garlic, lemon, turmeric, and black pepper cleanses the kidneys naturally in two weeks. The claim is FALSE.
In an Instagram post, it is claimed that a homemade drink made with garlic, lemon, turmeric, and black pepper cleanses the kidneys naturally in two weeks. In the video posted by healing1natural, known alternative health care promoter who advertises unsupported health practices, Barbara O’Neill is seen making several claims. She is heard saying, “Think of this, and you’ll never set foot in a hospital again. It cleanses your kidneys, boosts your immunity, cleanses your respiratory system, detoxifies your digestive system, and reduces inflammation in the body. First, we need three cloves of garlic, cut them into slices. Next, we’re going to use two lemons.
Cut as shown in the demonstration, then we have to add a teaspoon of turmeric powder and a pinch of black pepper, which will increase the efficacy of this drink by 2,000% making it a powerful antibiotic drink. Put half a liter of water and the ingredients we’ve just prepared in a pot. Cook over high heat for 10 minutes. Then strain the mixture. How to take it? Drink one of these drinks for two weeks.
You can add a teaspoon of honey to sweeten it. After two weeks, your kidneys will be as good as new, your digestive and respiratory systems will be completely cleared, and all your organs will be working in complete harmony.”
The claim can be accessed here.
The claim is FALSE. There is no scientific research or medical consensus supporting the idea that these four ingredients either alone or together cleanse or detoxify the kidneys that too in a short span of two weeks. Further the user has posted an old video of ,Barbara O’Neill, a known alternative health care promoter who is infamous for adverting unsupported health practices
Most people are born with two kidneys, each roughly the size of an adult fist, located on either side of the spine just below the rib cage. Despite their small size, kidneys carry out numerous essential functions to maintain the body’s balance. They remove waste and excess fluids, filter the blood by retaining some compounds while eliminating others, and assist in the production of red blood cells. Additionally, kidneys help regulate the balance of vital vitamins and minerals, maintain blood pressure, and contribute to bone health.
The kidneys are cleaned through a process called filtration. Blood enters the kidneys through an artery from the heart. Inside the kidneys, millions of tiny filters called nephrons remove waste and excess substances from the blood. The filtered blood, now free of waste, is returned to the body through veins. The waste is converted into urine, which travels through the ureters to the bladder for storage. Once the bladder is full, urine is expelled from the body through the urethra. This filtration process helps maintain the body’s fluid balance and eliminate waste.
Garlic, a widely used kitchen ingredient, has been valued in traditional herbal medicine for its rich content of organosulfur compounds. These compounds exhibit various therapeutic and biological effects, which vary based on how garlic is prepared, used, or extracted. Garlic is recognized for its antioxidant, anti-inflammatory, and immune-regulating actions, contributing to immune system stability by modulating immune cell function and cytokine activity. These effects highlight its potential in managing infections and certain cancers. Moreover, garlic’s organosulfur compounds support cardiovascular health by influencing lipid profiles and exerting blood pressure-lowering and antiplatelet properties.
Lemons are a rich source of vitamin C, a vital nutrient that strengthens the immune system and enhances the body’s ability to fight infections. They also contain powerful antioxidants that help counteract oxidative stress and inflammation, contributing to better heart health by improving cholesterol profiles and lowering blood pressure. The citric acid found in lemons aids digestion by promoting gastric juice secretion, while their alkalizing properties help maintain the body’s pH balance. Furthermore, the vitamin C in lemons supports skin health by boosting collagen synthesis and minimizing signs of aging.
Turmeric, commonly known as Haldi, is derived from the rhizomes of Curcuma longa L. and is widely recognized for its vibrant orange-yellow hue and distinctive flavor, primarily due to its active compound curcumin. It possesses notable anti-inflammatory, antimicrobial, and anticancer properties. In Ayurvedic practice, turmeric is traditionally used to manage a range of respiratory conditions such as asthma, allergies, and bronchial hyperreactivity, along with liver ailments, loss of appetite, rheumatism, diabetic wounds, cough, sinusitis, and nasal discharge.
Black pepper, often referred to as the “King of Spices,” is prized not only for its culinary use but also for its wide range of therapeutic benefits. It contains bioactive compounds such as piperine, which contribute to its antimicrobial, antioxidant, antidiabetic, and lipid-lowering effects. Research suggests that black pepper may help combat infections and mitigate oxidative damage. Additionally, it exhibits anti-inflammatory, pain-relieving, and neuroprotective properties.
The claim that a homemade drink containing garlic, lemon, turmeric, and black pepper can naturally cleanse the kidneys in two weeks is false. While these ingredients have general health benefits and might support the kidney health, there is no scientific evidence to support the idea that this combination detoxifies or cleanses the kidneys in two weeks.
Garlic may offer potential benefits for kidney health by helping to reduce inflammation linked to kidney function. The findings of a study by Elham Zare et. al., published in BMC Nephrology, suggest that administering 400 mg of standardized garlic extract twice daily for eight weeks led to a significant decrease in inflammatory markers, including Interleukin-6 (IL-6), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR).
Although there is no scientific evidence or medical consensus supporting the claim that lemon juice can detoxify the kidneys, research suggests it may help protect against kidney stone formation. In a review conducted by Yazeed Barghouthy et. al., lemon juice was found to increase urinary citrate levels, a key factor in preventing kidney stones. However, the study also reported that lemon juice had minimal impact on raising urine pH, indicating a limited alkalinizing effect.
Turmeric contains the bioactive compound curcumin, known for its wide-ranging health benefits. A review by Siddhartha S. Ghosh et. al. highlighted curcumin’s potent anti-inflammatory and antioxidant properties, along with other therapeutic effects, suggesting that it maybe a promising addition to treatment approaches for chronic kidney disease.
Black pepper contains piperine, a bioactive compound known for its health-promoting effects. According to research by Maryam Mohammadi et. al., piperine may help protect the kidneys from acute injury caused by ischemia-reperfusion (a type of blood flow disturbance and restoration). This protective effect is largely attributed to its anti-inflammatory and antioxidant properties.
In addition, the video recommends adding honey to the mixture. Honey does have certain properties that may support kidney health. A study by R. B. Nerli et.al. found that oral administration of honey helped may prevent kidney damage by reducing inflammation, suggesting its potential protective effect on the kidneys.
The ingredients mentioned in the video such as garlic, lemon, turmeric, black pepper, and honey may offer certain health benefits for the kidneys, particularly due to their anti-inflammatory and antioxidant properties. However, there is no scientific evidence to support the claim that these ingredients can cleanse the kidneys within two weeks or act as a detox treatment.
Dr Sashi Kiran A, Consultant Nephrologist, Yashoda Hopsitals, Malakpet, Hyderabad in a conversation with The Medical Dialogues Fact Check Team said, “There’s a lot of buzz around natural detox drinks, but the idea that a mixture of garlic, lemon, black pepper, and turmeric can cleanse the kidneys isn’t backed by scientific evidence. Kidneys are already highly efficient at filtering waste and toxins from your blood. While these ingredients do have some antioxidant and anti-inflammatory properties, they don’t directly “detoxify” the kidneys. For example:
– Lemon contains citrate, which may help prevent kidney stones
– Garlic has antimicrobial and heart-health benefits.
– Turmeric contains curcumin, which has anti-inflammatory effects.
– Black pepper enhances curcumin absorption but doesn’t directly impact kidney function.
The best way to support kidney health is staying hydrated, eating a balanced diet, and avoiding excessive salt and processed foods. If you’re looking for kidney-friendly drinks, water, lemon water, and cranberry juice are better options.”
Dr Tarun Kumar Saha, Sr. Consultant Nephrologist & Transplant Physician, Yashoda Hospitals, Secundarabad, Hyderabad further said, “This is in response to the video which is being circulated claiming that the mixture of clove, garlic, turmeric and lemon can heal and cure kidney diseases. This is not the true scientific statement.
Although the mixture is helpful to prevent the metabolic syndrome but when there is established kidney disease, these mixtures cannot cure kidney diseases. In fact, in a patient whose kidney function is impaired, this may cause high potassium level in the blood which can be dangerous for kidney disease patients. These claims give a false hope in kidney patients and may endanger their life.”
There is no scientific evidence or established medical consensus to support the user’s claim. While garlic, lemon, turmeric, and black pepper each have well-documented health benefits and may contribute to overall kidney support, the idea that combining these ingredients can cleanse the kidneys within two weeks is false.
Hence, the claim by the user is FALSE.
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North Chicago: AbbVie has received accelerated approval from the U.S. Food and Drug Administration (FDA) for EMRELIS (telisotuzumab vedotin-tllv) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy. High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test.
This indication is approved based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
EMRELIS is a c-Met-directed antibody-drug conjugate (ADC) and a treatment approved for this patient population. ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent ‘payload’ directly to the biomarker-expressing cell.
Approximately 85% of lung cancers are classified as NSCLC and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world. The c-Met protein is found to be overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients and is associated with poor prognosis. Approximately half of these patients have high c-Met overexpression, defined as ≥ 50% of tumor cells with strong (3+) staining by immunohistochemistry (IHC) test.
“We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes,” said Jonathan Goldman, MD, professor of medicine, director of thoracic oncology clinical trials, UCLA. “People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and EMRELIS is a first-in-class ADC that can address a critical unmet need for this patient population.”
“EMRELIS, AbbVie’s first internally developed solid tumor medicine and our first solid tumor FDA approval in lung cancer, is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease,” said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie. “Leveraging advanced technology and data science, we are growing our ADC portfolio designed to deliver the right medicines to the right patients in need across a range of difficult-to-treat tumors.”
“Despite the progress we have seen in the treatment of lung cancer, we need more options for people whose treatments stop working,” said Upal Basu Roy, PhD, MPH, executive director of research, LUNGevity Foundation, a leading lung cancer nonprofit organization. “This approval is a welcomed targeted therapy for those with high c-Met protein overexpressing late-stage, non-small cell lung cancer who have seen very limited treatment innovation in the last decade.”
The FDA accelerated approval is supported by data from the Phase 2 LUMINOSITY study (NCT03539536), a study designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations. Findings from the study showed patients with high c-Met protein overexpression (n=84) who received EMRELIS demonstrated a 35% (95% CI: 24, 46) Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months (95% CI: 4.2, 12).
In December 2021, the FDA granted EMRELIS Breakthrough Therapy Designation (BTD) based on Phase 2 LUMINOSITY study data.
EMRELIS is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites.
The FDA has also approved the Roche VENTANA MET (SP44) RxDx Assay, the only IHC companion diagnostic that identifies patients eligible for treatment with EMRELIS. To determine c-Met protein biomarker status, patients can be tested on recent or archived tissue.
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Thiruvananthapuram: Expressing concern over the medical board’s report regarding the woman who continues to be in critical condition after a botched fat removal surgery, the patient’s family alleged that the report is unclear and gave a clean chit to the private clinic. They announced plans to approach the court if health department authorities fail to take appropriate action.
The family has also filed a complaint against the medical board for their alleged lack of clarity and protection of the guilty authorities of the private cosmetic clinic, they demanded strict action against the hospital owner. Not only the victim’s family but the police also expressed their displeasure with the medical board report.
It is to be noted that the clinic was being operated without a valid license at the time of the surgery. When the patient’s botched surgery became controversial, the clinic authorities immediately obtained the registration.
Also read- Botched Cosmetic Surgery: Thiruvananthapuram private clinic’s license cancelled
Medical Dialogues recently reported that the Kerala Health Department cancelled the clinic’s licence. This comes after the department discovered that the clinic was operating in violation of licence conditions. It was reported that the clinic rushed to obtain its registration within just a month of applying, even though the standard process typically takes around two months for medical establishments.
Speaking to TNIE, the patient’s husband said, “We are disappointed with the medical board report. Since the beginning, we have been demanding action against the hospital owner, who is also a doctor. The clinics were run without a licence. Despite prima facie evidence, the health department has not bothered to conduct an inquiry.”
Medical Dialogues had earlier reported that an expert committee of doctors appointed by the state health department confirmed that the clinic failed to follow standard medical procedures during the surgery. The committee was headed by DMO Dr Bindu Mohan and comprised Head of the Forensic Department of Government Medical College, Dr Sreedevi, and public prosecutor Geena Kumari.
On February 22, M.S. Neethu, a resident of Sreevaraham in Muttathara, underwent a fat removal procedure on her lower abdomen at the ‘Cosmetic Hospital’ in Arasummoodu, Kazhakoottam. She was discharged the next day, but according to a complaint filed by her husband, Padmajith, she soon developed severe fatigue and other alarming symptoms.
Despite informing the attending doctor, she was reportedly only advised to consume salted porridge and water. Her condition deteriorated rapidly, and on February 24, she was rushed back to the clinic. Staff at the clinic arranged for her transfer to another private hospital, citing complications including dangerously low blood pressure. There, she reportedly suffered a cardiac arrest following the procedure, which was conducted in February. She has been on ventilator support ever since.
The committee stated that despite the patient having dangerously low blood pressure, she was kept for 12 hours without a ventilator at the facility. Additionally, the patient had a history of heart issues, the surgery was performed without the presence of a cardiologist. The committee also found that the cosmetic clinic, which performed complex surgeries, did not have ambulance facilities and was operating despite not being registered as a medical establishment.
However, the police will likely refer the case to an apex committee to decide on the allegations.
Also read- Patient dies post hair transplant surgery, Kanpur MBBS doctor booked for negligence
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