Category Archives: Alternative Medicine

VANCOUVER, BC, Nov. 18, 2021 /PRNewswire/ --Advances in the collective genetic understanding of diseases, and the ability to identify disease biomarkers, is ushering in a new era of personalized medicine. Technologies such as CRISPR/Cas9 are also paving the way for improved, more tailored treatments targeted to a specific genetic marker of a disease. As our understanding of the molecular underpinnings of disease continue to improve, so, too, will the technologies at our disposal to treat them.

We've already seen the benefits of this type of personalized medicine in the cancer realm. Using a person's (or disease's) genes to drive cancer therapy is known as precision medicine. Precision medicine can help doctors identify high-risk cancer patients, choose treatment options, and evaluate treatment effectiveness. Precision medicine can also be used to prevent certain types of cancer, diagnose certain types of cancers early (leading to earlier treatment and better outcomes), and diagnose specific types of cancer more correctly.

As targeted therapies continue to advance, we will continue to see their impacts flow beyond that of the cancer realm. One area in which interest is ramping up is neurodegenerative diseases, which are chronic, progressive diseases affecting the brain and its constituent cells. Neurologic disease can be genetic, or caused by a stroke or brain tumor. Examples of neurodegenerative disease include Alzheimer's Disease, Parkinson's Disease, and Huntington's Disease. These diseases have a genetic component, with specific genes playing a role in the development and progression of disease, especially in rare forms. Neurodegenerative conditions, like cancer, are devastating and costly. Collectively, neurodegenerative conditions cost people in the United States $655 billion in 2020.

Can we apply concepts from targeted therapies developed for cancer to create better outcomes for patients suffering from neurodegenerative diseases? What's more, can precision medicine be used to treat other large unmet needs in the field of neurology, such as neuropsychiatry, pain, epilepsy, sleep disorders, and stroke?

Precision medicine in neuroscience and neurology is where many companies have dedicated their time and efforts. Three companies trading on the NASDAQ in this space that investors should research are Alnylam, Ionis Pharmaceuticals, and Regeneron.

Neuroscience research companies are clamoring to make use of the plethora of cellular and molecular biology data that is emerging about drugs and the patients who use them. There is much more information to be gleaned from diseases and patients than the genetics, which may not reveal information about the ways that genes are formally transcribed and expressed. Emerging technologies, therefore, also look at the RNA profiles of a drug response, patient, or disease state, called transcriptomics; and the set of proteins expressed by a cell, tissue, or organism, called proteomics. While a challenge with gene therapy is reimbursement by insurance providers, research is underway that can make gene therapies more common, and pave the way for more established insurance structures.

RNA targeting is an active area of research for neurodegenerative disease, with companies such as Skyhawk Therapeutics, Regeneron Pharmaceuticals, Alnylam Pharmaceuticals, and Takeda involved. By modifying genetic transcription via RNA technologies, these companies hope to develop novel treatments for disorders of the central nervous system. The study of RNA profiles in a given cell, tissue, or organism is known as transcriptomics, and this area will likely heat up as these researchers work to develop pioneering RNA technologies to target neurodegenerative disease.

Proteomics, or the study of the proteins expressed by a cell, tissue, or organism, will also play a role in precision medicine for neurological disorders. In June 2021, the United States Food and Drug Adminstration approved the first therapy addressing the underlying biology of Alzheimer's disease. The drug, Biogen's Aducanumab, is a monoclonal antibody therapy that works by clearing a substance known as beta-amyloid, a protein that scientists believe causes Alzheimer's, from the brain. The drug, which was found to exhibit a unique proteomic profile upon treatment in mice, was the first approved for Alzheimer's in 20 years, and while it is thought to be effective in a limited number of Alzheimer's disease cases (namely, people in the early stages of Alzheimer's), it represents a step forward in neurodegenerative disease research.

The FDA's approval of Aduhelm, which was under an accelerated timeframe, has created more interest in the area of Alzheimer's and Parkinson's disease treatments. Scientists believe that a protein called tau is more closely associated with dementia than beta-amyloid, so they are also seeking to develop drugs targeting tau protein. In the realm of Parkinson's disease, research is underway to target a compound called alpha-synuclein, which, like amyloid beta and tau protein in Alzheimer's, is associated with cognitive decline in Parkinson's disease. There are a number of approaches in development to target tau. Investors can expect many more biotech companies and venture firms moving into this space to develop innovative and alternative treatments.

This work is not without significant challenges. One obstacle in neurodegenerative research is creating drugs that can bypass the brain's blood-brain-barrier, which keeps the brain safe from toxic substances or pathogens that would otherwise make their way into the brain. Another challenge is the fact that neurodegeneration affects a subset of neurons, which may have different levels of vulnerability to such disease. It is not yet fully clear which factors predispose certain neurons to develop pathology over others.

Yet as drug discovery continues to leverage the latest techniques in genomics, transcriptomics, and proteomics, and combinations of these technologies, this will unlock new potential for companies to create novel, increasingly personalized, therapies. For example, advances in genomics may provide insight into how neurodegeneration occurs in the brain.

Drug discovery in neurodegeneration also overlaps with that of other diseases, due to common disease pathways. For example, phosphatidylinositol 3-Kinase (PI3K) inhibitors are implicated not only in COVID-19 and breast cancer, but also Parkinson's Disease. Stem cell therapies, which could benefit patients suffering from many conditions, can also have significant applications in the neurodegenerative realm. Stem cells could potentially be used to restore lost brain tissue, or to release compounds such as anti-inflammatory factors and growth factors supporting repair of the nervous system. Stem cell therapies, which are already in use for conditions such as cancer, could thereby restore function to neurodegenerative patients. Therefore, advances made in the treatment of other disease states could potentially innovate the field of neurodegeneration as well.

PRLog ID: http://www.prlog.org/12894142

SOURCE Braeden Lichti

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Braeden Lichti - Investing in Precision Medicine to Yield New Treatments for Neurodegenerative Diseases - PRNewswire

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. The approval is based on data from the pivotal Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) compared to placebo. Median DFS has not been reached for either group.

Despite decades of research, limited adjuvant treatment options have been available for earlier-stage renal cell carcinoma patients who are often at risk for recurrence. In KEYNOTE-564, pembrolizumab reduced the risk of disease recurrence or death by 32%, providing a promising new treatment option for certain patients at intermediate-high or high risk of recurrence, said Dr. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and professor of medicine, Harvard Medical School. With this FDA approval, pembrolizumab may address a critical unmet treatment need and has the potential to become a new standard of care in the adjuvant setting for appropriately selected patients.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

KEYTRUDA is foundational for the treatment of patients with certain advanced cancers, and this approval marks the fourth indication for KEYTRUDA in earlier stages of cancer, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. KEYTRUDA is now the first immunotherapy approved for the adjuvant treatment of certain patients with renal cell carcinoma. This milestone is a testament to our commitment to help more people living with cancer.

In RCC, Merck has a broad clinical development program exploring KEYTRUDA, as monotherapy or in combination, as well as other investigational products across multiple settings and stages of RCC, including adjuvant and advanced or metastatic disease.

Data Supporting the Approval

KEYTRUDA demonstrated a statistically significant improvement in DFS in patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions compared with placebo (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010). The trial will continue to assess overall survival (OS) as a secondary outcome measure.

In KEYNOTE-564, the median duration of exposure to KEYTRUDA was 11.1 months (range, 1 day to 14.3 months). Serious adverse reactions occurred in 20% of these patients receiving KEYTRUDA. Serious adverse reactions (1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% of those treated with KEYTRUDA, including one case of pneumonia. Adverse reactions leading to discontinuation occurred in 21% of patients receiving KEYTRUDA; the most common (1%) were increased alanine aminotransferase (1.6%), colitis and adrenal insufficiency (1% each). The most common adverse reactions (all grades 20%) in the KEYTRUDA arm were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%) and hypothyroidism (21%).

About KEYNOTE-564

KEYNOTE-564 (ClinicalTrials.gov, NCT03142334) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating KEYTRUDA as adjuvant therapy for RCC in 994 patients with intermediate-high or high risk of recurrence of RCC or M1 no evidence of disease (NED). Patients must have undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion[s] in M1 NED participants) with negative surgical margins for at least four weeks prior to the time of screening. Patients were excluded from the trial if they had received prior systemic therapy for advanced RCC. Patients with active autoimmune disease or a medical condition that required immunosuppression were also ineligible. The major efficacy outcome measure was investigator-assessed DFS, defined as time to recurrence, metastasis or death. An additional outcome measure was OS. Patients were randomized (1:1) to receive KEYTRUDA 200 mg administered intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity.

About Renal Cell Carcinoma (RCC)

Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCCs. Renal cell carcinoma is about twice as common in men than in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. In the U.S., it is estimated there will be more than 76,000 new cases of kidney cancer diagnosed and almost 14,000 deaths from the disease in 2021.

About Mercks Early-Stage Cancer Clinical Program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS 1)] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):

Non-muscle Invasive Bladder Cancer

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Cancer

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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FDA Approves Merck's KEYTRUDA (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery - Business...

56-year-old Kritika Sharma was diagnosed with high blood sugar levels during a routine blood check up. On her familys insistence, she consulted a doctor who prescribed her medication. But she chose not to take the prescribed medication and opted for natural remedies to control her sugar. Subsequent tests showed that she was not able to control her blood sugar levels and after five years of resistance, she finally started her medication when diabetes started to affect her vital organs. Dr. Sunil Mishra, Director of Endocrinology and Diabetology at Medanta shares how this is a common occurrence. If there are no immediate complications to begin with despite the high readings, patients are not inclined to treat diabetes with medication. However, it needs to be noted that asymptomatic diabetes in the long run is good enough to create a complication. We know to a large extent type 2 diabetes is not curable. Also, scientific studies have shown that the golden time to treat diabetes is in the first 5-10 years. This is considered the golden period because if it's treated well from the beginning, long term diabetes complications are low. There are a few people who when they lose weight (30-50% with lifestyle modifications) may be able to reverse the diabetes.Dr. Shraddha Bhure, Medical Director, Boehringer Ingelheim, India adds, Heightened awareness and debunking of myths around diabetes can go a long way in convincing people to take appropriate measures. For instance, some people believe diabetes isnt a serious condition and hence avoid medication, as they are unaware of the complications which can occur if the disease isnt managed correctly. Additionally, some patients avoid diabetes medication due to a fear of side effects and switch to alternative therapies completely. Alternative therapy options like Ayurveda or Homeopathy can well complement in treating diabetes. Every alternate therapy has multiple approaches to offer, but eventually its the physicians call to decide whats best for the patient.Dr. Kushal Banerjee, a second-generation homeopath at Dr. Kalyan Banerjees Clinic recommends that all patients should consider homeopathy as an important option to manage their diabetes. In the early stages, along with strict lifestyle management, the majority of patients may be able to stop all medicines for life. He adds, No matter which system of medicine is taken, changes in lifestyle including diet, meal timings, exercise, sleep pattern and management of stress are key to improving your health.

The journey of diabetes is lifelong, and poses risk of multitude of complications, if uncared for. It is not about merely high blood-glucose level, but the associated risk of complications, adverse events, and even premature mortality, that poses priority for meticulous and sustained care. The commonly known type-2 diabetes mellitus (T2DM) is an outcome of imbalance between the metabolic load, versus the body's physiological capacity. Unhealthy lifestyle practices with excess dietary calorie consumption and limited physical activity, poor stress management, as well as genetic and constitutional factors, predispose to the risk of T2DM and associated complications. The approach to good diabetes-care is based on some founding principles, which may be simple to understand but need a committed effort to sustain in the long run, adds Dr Bhure.

Below are the ABCDEF of diabetes care:

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Why do people resist blood sugar medication in favour of alternative therapies? Is it safe? - Times of India

Pregnant women are using marijuana more often and are turning to their dispensaries for medical advice instead of healthcare professionals, WSU Insider reported Nov. 15.

Daily or near-daily use of marijuana has increased among pregnant women to 3.4 percent in 2017, and past month usage has nearly doubled, to 7 percent, since 2002. Despite the increase, health guidance and education has remained much the same, making many healthcare professionals ill-prepared to advise patients.

Current national guidelines advise women who are pregnant not to use cannabis which has been linked to a variety of birth defects. Some pregnant women are turning to "budtenders," commercial marijuana sellers, for advice and guidance on taking the drug after reporting feeling stigmatized by health professionals.

A new study surveyed both 10 medical professionals and 10 commercial marijuana sellers to understand their perceptions and knowledge of perinatal cannabis use. It found that both groups understood that pregnant women were often seeking cannabis as an alternative medicine to relieve pain and nausea associated with childbearing.But the budtenders had a more positive view of cannabis use during pregnancy, with some saying it has positive effects or no effect at all.

Healthcare professionals were far more concerned. Cannabis use in pregnant women has been linked to a range of birth defects including lower birth weight, still birth and neurodevelopmental issues.

The authors of the study suggest that more training and education need to be given to healthcare workers on this topic, since pregnant women often reported their encounters with medical professionals as generally unhelpful. The healthcare workers in the study reported the need to change their clinical practices to address the reported increase in perinatal cannabis use.

"We need to use all approaches and all people in the patients life to help them," said Celestina Barbosa-Leiker, vice-chancellor for research at Washington State University Health Sciences and an author of the study. "There is such limited research with budtenders, but they need to be part of this conversation because they are seen as trusted sources by their customers and our patients."

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Healthcare professionals want more training to address increase in perinatal cannabis use, study finds - Becker's Hospital Review

This article was originally published here

J Community Health. 2021 Nov 12. doi: 10.1007/s10900-021-01046-4. Online ahead of print.

ABSTRACT

Black men have the highest rate of prostate cancer (PCa) morbidity and mortality in the US, and often receive delayed and/or poorer-quality treatment. This inequity has led many to turn to complementary and alternative medicine/therapies (CAM). However, little is known about the use of these therapies within the Black community. The purpose of this study was to describe types of CAM therapies used, and the reasons behind their use for overall health and PCa treatment and prevention among three groups of Black males, namely African Americans, Caribbean Immigrants and African Immigrants. This study used a mixed-methods design with a quantitative phase (n = 575) followed by a qualitative phase (n = 61) with participants recruited from various parts of the country. Results revealed differences among subgroups in CAM use for overall health and PCa, as well as differences in the types of CAM therapies used and differences in the reasons behind their use. The findings of this study reveal a prevalence of CAM use for overall health and PCa within three different groups of Black men and identifies the specific CAM used. There were significant differences in the types of CAM used by each subgroup for both overall health and PCa. This study also shows that there is value in looking at Black subgroups distinctively, for their rates of CAM use and reasons for use, are distinctly different.

PMID:34773196 | DOI:10.1007/s10900-021-01046-4

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Use of Complementary and Alternative Medicine for Prostate Cancer among African Americans, African Immigrants and Caribbean Immigrants - DocWire News

A group health insurance plan offers unlimited customizations at significantly lower premiums compared to retail health insurance plans for individuals. Therefore, a group health insurance policy is highly recommended to cover standard groups of people like employers/employees, formal associations and financial institutions. Its important to keep track of new-age policies that can help your group select the right benefits and maximize the effect of the insurance for every individual in the group.

Here are some benefits that modern companies and associations set up with their insurance provider to safeguard their members health and financial well-being. Some insurance startups support most of these by default, and some may come at an additional cost.

Psychiatric treatments: For a long time, health insurance only covered physical health issues. Insurance Regulatory and Development Authority of India (IRDAI) has asked health insurance companies to add mental illnesses to all regular health insurance policies. These policies usually cover in-patient hospitalization expenses for mental illness.

Chemotherapy for cancer patients: Cancer treatment can be long and financially destabilizing. A cancer-specific policy is a special case of critical illness policies. It can help cover costs associated with diagnosis, hospitalization, chemotherapy, radiation, and surgery.

Ayurvedic treatment coverage: Modern insurance companies now embrace alternative perspectives without judgement. If you prefer to opt for alternative medicine, look out for provisions that cover Ayurveda and non-allopathic medicines. Thanks to IRDAI, many insurance providers are not restricted to allopathic medicine.

LGBTQ and live-in partner cover: Allowing all individuals in the group to include their partners in the health insurance plan, regardless of sexual orientation or marital status, is a good and inclusive practice. Many group health insurance platforms provide LGBTQ partner and live-in partner coverage at no additional cost.

Lasik cover for even +/- 5 correction: Lasik or laser eye surgery is a type of refractive surgery that offers a long-term alternative to eyeglasses or contact lenses. Many insurers used to consider this a cosmetic surgery, but modern insurance companies can come to the rescue for surgery and treatment. It is important to note that a huge chunk of our population suffers from vision-related issues.

Stem cell, robotic surgery and cyberknife: Some insurance companies fail to keep up with new treatment procedures that are not based on common medical practice. Make sure to check your policy to see if these are excluded. With a view to increasing the scope of health insurance coverage, IRDAI is reducing the number of exclusions of technologically advanced procedures.

Air ambulance cover: Its always good to have health insurance that can cover emergencies even at inaccessible locations. Air ambulance is a service where an aeroplane or helicopter is used to transport patients to a hospital. New-age insurance policies offer help in arranging the air ambulance and reducing the costs involved in its operations.

Internal and external congenital diseases: People who suffered genetic disorderslike cleft lip and heart defectsfound it difficult to get coverage for their treatments. IRDAI recently issued guidelines that allow health insurance companies to cover both internal and external, or visible, genetic disorders.

IVF: In vitro fertilization (IVF) is a set of procedures that can help with fertility and help a couple having difficulties in conceiving a child. They are often not covered by insurance companies. However, many new-age policies include coverage with long waiting periods to prevent fraud.

Surrogacy: Subject to proper documentation of infertility and surrogacy, the same conditions as maternity coverage in a health insurance policy will apply. However, only the maternity expenses of the surrogate mother will be covered.

Dental treatments: Health insurance companies do not provide coverage for dental treatments as many treatments fall under the cosmetic category. However, dental procedures can be covered as out-patient procedures (OPD) with a few restrictions.

Organ donor expenses: Some critical cases and medical emergencies may require removal of damaged organs. A few health insurance companies help cover the expenses incurred by the organ donor with reasonable limits.

Every insurance provider offers a long list of exclusions of the policy. Make sure you check whether the costs of treatment are covered or not and obtain documentation of all the terms and conditions. Ensure that your group health insurance plan offers competent claims support and makes your documents accessible with a few clicks.

High-quality group health insurance also stretches into preventive care and maintenance of good health. It is not uncommon for a new-age policy to include doctor teleconsultations, dental checkups, mental wellness sessions, fitness memberships, and other health benefits that are adapted to match your groups needs.

The author is Co-founder, Plum.

DISCLAIMER: Views expressed are the author's own, and Outlook Money does not necessarily subscribe to them. Outlook Money shall not be responsible for any damage caused to any person/organisation directly or indirectly.

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New-age Group Policies Offer Wider Health Cover - Outlook India

JOHANNESBURG, Nov. 16, 2021 /PRNewswire/ --Today OncoBeta GmbH, a medical device company specialising in innovative epidermal radioisotope therapies for non-melanoma skin cancers (NMSCs), has expanded its offering of non-invasive skin cancer therapy Rhenium-SCT (Skin Cancer Therapy) in South Africa, with treatments now taking place at the Busamed Modderfontein Private Hospital in Lethabong, Johannesburg.

The global incidence of NMSCs continues to rise, with more than 7 million NMSC cases reported each year.1 Incidence rates for NMSC remain high in South Africa over indexing the rest of the world, showing 16.3 people per 100,000 develop NMSCs, as compared to 11 per 100,000 globally.2 Worryingly, this is considered a conservative estimate of NMSC in South Africa, as incomplete case reporting to the National Cancer Registry means the country's NMSC rates are often grossly underreported.3

Rhenium-SCT is an innovative, non-invasive procedure, providing unparalleled aesthetic results, even in cases otherwise considered difficult to treat.4-6 It is an epidermal radioisotope therapy that is ideal for the targeted treatment of superficial skin cancers. Rhenium-SCT has been available for NMSC patients in South Africa since 2018 by OncoBeta's distribution partner, Tautomer (PTY) LTD, along with the lower-dose Rhenium-188, which is currently available for the treatment of keloids.

On 12 November, Dr. Zuma from Busamed Modderfontein Private Hospital in Johannesburg and her team who have been trained and certified for the Rhenium-SCT Therapy, have successfully performed their initial Rhenium-SCT treatment.

Dr. Zuma says, "This non-invasive local treatment of non-melanoma skin cancer with Rhenium-SCT is a great alternative treatment to surgery and can be undertaken in a single session with excellent aesthetic outcomes, improving results and quality of life for the patients."

Rhenium-SCT will be provided to patients in South Africa by OncoBeta's distribution partner Tautomer (PTY) LTD, along with the lower-dose Rhenium-188, which is currently available for the treatment of keloids.

Martin Magwaza, CEO of Tautomer (PTY) LTD, says the increasing incidence of skin cancers places major financial strain on South Africa's already overburdened public healthcare system, costing the country an estimated ZAR 92.4 million (US$15.7 million) in treatments annually.7 "Tautomer is committed to providing South Africans with innovative and effective therapies in the treatment of non-melanoma skin cancers."

OncoBeta CEO Shannon D. Brown III says, "We are excited to see that the access for patients to the Rhenium-SCT is expanding within South Africa. It is truly inspiring that more and more patients and physicians around the globe are recognizing and experiencing the benefits of this ground-breaking technology."

OncoBeta's Rhenium-SCT is currently available in Australia, South Africa, Italy, Germany, Switzerland and more recently Austria as part of its global roll-out.

About the Rhenium-SCT (Skin Cancer Therapy)Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans. The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.8

The Rhenium-SCT is a painless*, single session, non-invasive therapy providing for unparalleled aesthetic results, even in cases otherwise considered difficult to treat.4-6 The Rhenium-SCT utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). The Rhenium-SCT is a precise, personalised therapy that is only applied to the area needed to treat without affecting the healthy tissue. The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patient's skin and the application is safe and simple for the applying physician. Most cases of NMSCs (Basal Cell Carcinomas and Squamous Cell Carcinomas) can be treated using the Rhenium-SCT in one single session6. Scar-free healing6 of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment6.

About OncoBetaOncoBeta, with its headquarters located in Garching near Munich, Germany, is a privately held medical device company, specializing in the development and commercialization of state-of-the-art, innovative therapies. Since its foundation, OncoBeta has concentrated its efforts on the development, regulatory approval(s) and commercialization of the epidermal radioisotope therapy Rhenium-SCT (Skin Cancer Therapy), targeting NMSCs. OncoBeta has perfected the customized application and device management system in conformity with all health, safety and environmental protection regulatory standards.

Find out more about Rhenium-SCT: http://www.oncobeta.com

Follow us on social media:LinkedIn: http://www.linkedin.com/company/oncobeta-gmbh/Facebook: http://www.facebook.com/oncobeta/Instagram: http://www.instagram.com/oncobeta_gmbh/

About Tautomer (PTY) LtdTautomer is a privately owned, fully integrated Health Technology company based in Centurion, South Africa. Through our network of strategic partners, we engage in the development, manufacturing, and distribution of high-quality Nuclear Medicine based therapies and diagnostics. The primary focus in healthcare is to address the unmet medical needs in Oncology, Pain Management and Infectious diseases.

Find out more about Tautomer: http://www.tautomer.co.za

Forward-looking statementsThis announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of OncoBeta's control, and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning OncoBeta's plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. OncoBeta undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

*No reported pain4,5Complete tumour regression in 98.5% of lesions treated, with 89% after a single application6

References

Photos:https://www.prlog.org/12893836

Press release distributed by PRLog

SOURCE OncoBeta GmbH

http://www.oncobeta.com

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South African non-melanoma skin cancer patients now have greater access in the area of Johannesburg to innovative non-invasive treatment Rhenium-SCT -...

Innovations occur in medicine all the time. Some happen quickly, like the unprecedented speed with which the COVID-19 vaccines were developed. Others take more time to develop, as researchers leverage current knowledge and new ideas to develop novel pathways toward diagnosis, treatment, and survival for people with a wide variety of diseases.

Each column, we dive deeply into lab reports, journals, and conferences to bring you the most anticipated innovations coming down the pike for one of the most dreaded diseases: cancer. This round, our focus is on breast cancer. Among new developments to keep an eye on include:

A new AI tool may take breast cancer screenings to the next level by increasing radiologists accuracy when interpreting ultrasound images. Using a data set of more than five million images collected from 288,000 exams of roughly 143,000 patients, researchers have trained and validated an AI system to automatically identify malignant lesions in breast ultrasound images.

Findings from the study, which were published online in September 2021 in Nature Communications, show that the AI tool decreased the rate of false positives (samples erroneously categorized as positive) by 37.3 percent, significantly reducing the number of women referred for unnecessary biopsies.

Next StepsThe tool isnt quite ready for prime time, according to the researchers. More work is needed to further test its accuracy. They also plan to refine and personalize the tool to use patient-specific information (e.g., genetic history, family risk) to better inform evaluations and follow-ups.

RELATED: 6 Stretches to Help With Recovery After Breast Cancer Surgery

Researchers have discovered a way to activate cancer therapies, such as the drug Adriamycin (doxorubicin), directly in tumors, thereby reducing side effects felt throughout the rest of the body. (Adriamycin has been notoriously nicknamed the red devil for its color and difficult side effects.) The technology involves giving an inactivated form of chemotherapy intravenously and injecting an activating agent directly into the tumor. This approach to therapy, known as CAPAC (Click Activated Protodrugs Against Cancer), keeps the toxic effects of the chemotherapy mostly contained inside the tumor, while sparing the rest of the body the worst of the side effects. CAPAC can also be used for other tumor types that are amenable to direct injection.

In the first study in which the technology was used in humans, the results, presented at the European Society for Medical Oncology Congress in mid-September, showed that levels of SQ3370 (equivalent to conventional doxorubicin) were 50 times higher in the tumor than in the bloodstream, with no serious adverse events that would require dosage adjustments. The small experimental trial included nine patients, eight of whom had metastatic cancer, including triple-negative breast cancer. Cancer progression stabilized in more than half of the patients treated with CAPAC, including those in whom the disease had progressed when treated with prior Adriamycin or other chemotherapy agents.

Next StepsThe CAPAC platform is compatible with a variety of drugs, including some often limited in use because of their toxicity. The trial is ongoing, and researchers will continue to increase doses using the system. If CAPAC is successful, researchers may someday be able to leverage drug effectiveness while limiting or even eliminating some of the most toxic side effects.

RELATED: Breast Cancer Survivorship and the Impact on Mental Health

Liquid biopsies, which rely on identifying circulating DNA fragments from tumor tissue in the blood (also called circulating cell-free DNA, or cfDNA), might provide an alternative to traditional biopsies for certain patients.

Prior studies established that patients with advanced breast cancer have higher concentrations of cfDNA than those with benign tumors (or healthy persons). Researchers looked at data from a Finnish cancer project launched during the 1990s, a data set that included 204 breast cancer patients with nonmetastatic disease before treatment was started. Research findings, which were published in September 2021 in the journalCancers, showed that when the ratio of larger circulating DNA fragments versus smaller fragments was higher, the patient was likely to have a poorer prognosis.

Next StepsFuture studies will also focus on how liquid biopsies can be used to delineate breast cancer patients with a poor prognosis at the time of diagnosis, in order to improve treatment and outcomes.

RELATED: What Is a Liquid Biopsy for Lung Cancer and Do You Need One?

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New Directions: What Innovations Are Coming Down the Pike for Breast Cancer? - Everyday Health

The mystique surrounding traditional Chinese medicine both attracts and repels people, with some being seduced by the esoteric charisma of these alternative practices while others dismiss them as pseudoscience. Acupuncture and cupping are perhaps the most popular techniques associated with this tradition, with the latter being a famous yet controversial favorite of Olympic athletes.

There isno scientific consensus on the validity of either among doctors and researchers, but theres no question that acupuncture is held in higher regard than cupping, despite the fact that much of the science behind this prickly practice remains poorly understood. New research has begun to shed light on this enigmatic method, providing new insights into its potential plausibility as a treatment for a range of conditions.

While acupuncture is now employed fairly commonly by physiotherapists and other medical professionals, it is considered to be an alternative or complementary medicine, which means its efficacy remainsunproven and hotly debated.In the UK, for instance, acupuncture was recommended by the National Health Service (NHS) as a treatment for back pain until 2016, when new research emerged indicating that the practice is in fact no more beneficial than a placebo for this particular condition. Despite this, the NHS does still cover the cost of acupuncture inrare cases, and many patients continue to pay for the treatment privately.

Its worth pointing out, though, that the techniques used by healthcare experts arent necessarily the same as those favored by more traditional Chinese acupuncturists. This is because Western approaches to the technique are rooted in a scientific understanding of the physical anatomy, while older versions of acupuncture tend to be based around mystical concepts such as qi (pronounced chi), which refers to an unseen energy force.

In both cases, however, the basic principle centers around the activation of specific acupoints on the body, which supposedly have the ability to affect the physiology of distant body parts. For example, the insertion of needles into certain acupoints is said to be able to reduce bodily inflammation, and while the science behind this claim is not understood, a new study in the journal Naturemay have pinpointed one of the underlying mechanisms.

The new research builds on a previous study that revealed that electrically stimulating the sciatic nerve in mice triggers communication along the vagus nerve, resulting in an increase in dopamine secretion by the adrenal gland. This extra dopamine causes a reduction in the concentration of pro-inflammatory molecules called cytokines, thereby decreasing the chance of a so-called cytokine storm, which often drives severe, systemic inflammation and can be fatal.

In the new study, the researchers show that certain acupoints are innervated by neurons that have the capacity to activate this vagal-adrenal axis in mice, and that stimulating these points can extinguish a cytokine storm and reduce inflammation throughout the body. In order to produce this effect, however, neurons must express high levels of a certain receptor called the prokineticin receptor 213.

Based on their mice experiments, the study authors conclude that these neurons are highly abundant around a particular acupoint known as Zusanli, which is located in the hind leg. By activating this point, the researchers were able to suppress systemic inflammation after the rodents were exposed to a bacterial endotoxin. When the mice were genetically engineered to lack these receptors, however, acupuncture at the Zusanli point had no such effect.

Acupoints that are not innervated by these neurons, meanwhile, are incapable of activating the vagal-adrenal axis and preventing cytokine storms from erupting. For example, the Tianshi point, found in the abdomen, was found to lack this function.

This work provides the first neuroanatomic explanation for the function of different acupoints. However, it was carried out in mice, and larger-scale human studies are needed in order to investigate the role of each of these points and confirm the validity of the approach as a whole.

Cupping became a huge point of contention during the 2016 Olympic Games in Rio de Janeiro, as athletes from multiple nations took to the track, field, and pool riddled with gnarly round bruises. These blemishes are the unmistakable hallmarks of this alternative therapy that originated in China and involves placing heated cups on various body parts, creating a vacuum that sucks the skin upwards.In "wet cupping", this approach is combined with blood-letting.

Like a newly cupped athlete, however, the scientific basis for this approach is rather patchy. According to ancient traditional practice, the method improves blood flow, alleviates pain, and activates the immune system, although these claims are scientifically unproven and not supported by biology. The suction of the cups breaks small blood vessels in the skin, resulting in the characteristic red blobs users are left with. However, there is no scientific explanation or evidence for how this brings about any of the health benefits that have been claimed.

A number of studies have been carried out on the validity of the alternative therapy, often alongside acupuncture, though none have found concrete evidence yet. A large review of 135 randomized clinical trials found no reliable evidence that the method brings any advantages. Intriguingly, though, some of the data analyzed in this study hint towards a possible application for cupping in the treatment of herpes zoster, facial paralysis, acne, and cervical spondylosis, although the authors point out that the trialssupporting this evidence were of low methodological quality.

Given the lack of evidence and that the logic behind the technique is scientifically flawed, it's hard to defend the virtues of this technique, although athletes who won gold after getting cupped may beg to differ.

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Fact Check: What's The Science Behind Acupuncture And Cupping? - IFLScience

Blessing Ibunge

The Pharmaceutical Society of Nigeria (PSN) has urged the federal government to officially recognise traditional medicine practice as alternative healthcare delivery services in the country.

This is contained in the communique presented by PSN at the end of its 94th Annual National Conference, held in Port Harcourt, Rivers State.

The immediate past president of PSN, Sam Ohuabunwa, who read the communique at the weekend before the newsmen, noted that traditional medicines provides opportunity for patients to access alternative healthcare services.

He stressed that government should regulate and standardise the traditional medicines so that Nigerians who could not access the orthodox services can still afford a good healthcare services.

Ohuabunwa said: Conference advised that the integration of traditional, complementary, and alternative medicines into the health care delivery system provides opportunity for patients/ individuals to access alternative healthcare services and facilitate the attainment of universal health coverage.

Government ought to recognise traditional or alternative medicine officially, that we can have both systems working in this country. So if you come to the hospital and you want to follow the orthodox one, you have doctors who will attend to you and if you choose the alternative, you will also be attended to.

But then it can be regulated but right now is not regulated and anybody can put anything inside the bottle and call it a name and begin to use it to cure different diseases. So, what we are saying, regulate the traditional medicine, standardise the branding so that Nigerians can follow their choice according to your ability to pay.

Infact in Ghana they have started awarding degrees to traditional or alternative medicine practitioners, in that way you will improve cost, access, or other health challenge that orthodox medicine cannot handle. Conference agreed traditional medicines must be leveraged upon to facilitate medicines security, supply chain production, increase revenue generation through research aimed at product development.

Also, the conference further noted that the modern pharmacist as an apothecary should have knowledge of traditional, complementary, and alternative medicines in other to diversify their services.

The conference agreed that it was necessary to establish, encourage and strengthen the relationship between pharmacists and other healthcare providers.

Pharmacists must work to enhance the procurement policy to improve availability of rare drugs such as anticancer drugs etc.

Earlier in his speech, chairman of the conference, Odein Ajumogobia (SAN) highlighted the need for a more effective structure of drug manufacturing, importation, distribution, administration and control, especially in view of the current reliance on foreign sources for not only finished drug products but pharmaceutical raw materials, reagents and manufacturing equipment to provide safe, efficacious and good quality drugs to meet the health needs of Nigerians.

He mentioned that formulation of new strategies, strengthening achievements in areas where progress has been recorded, and addressing those areas that call for more effective action, must be prioritized.

Prof. Moji Adeyeye in her keynote address discussed the disruptions of socioeconomic well-being of the public, unprecedented pressure on healthcare systems and the inability of the existing capacities to provide full and affordable access to quality health care, which has affected even the most resourceful and advanced healthcare systems.

She mentioned that uncertainties over how the Covid-19 pandemic will progress added further complexities to the uncertain healthcare environment.

The theme of conference was COVID-19 Lessons: Broadening and Strengthening the Nigerian Pharmaceutical and Health Sector.

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Regulate Traditional Medicines as Alternative Healthcare Delivery Services, PSN tells FG - THISDAY Newspapers