Monthly Archives: January 2021

Common Brain Malformation Affecting About 1 in 100 Children Traced to Its Genetic Roots – SciTechDaily

Posted: January 3, 2021 at 9:37 pm

The lowest part of a childs brain is visible below the bottom of the skull in this MRI scan and shows evidence of a Chiari 1 malformation. Researchers at Washington University School of Medicine in St. Louis have shown that Chiari 1 malformation can be caused by variations in two genes linked to brain development, and that children with large heads are at increased risk of developing the condition. Credit: David Limbrick

Discovery could aid early screening, shed light on how Chiari malformation arises.

About one in 100 children has a common brain disorder called Chiari 1 malformation, but most of the time such children grow up normally and no one suspects a problem. But in about one in 10 of those children, the condition causes headaches, neck pain, hearing, vision and balance disturbances, or other neurological symptoms.

In some cases, the disorder may run in families, but scientists have understood little about the genetic alterations that contribute to the condition. In new research, scientists at Washington University School of Medicine in St. Louis have shown that Chiari 1 malformation can be caused by variations in two genes involved in brain development.

The condition occurs when the lowest parts of the brain are found below the base of the skull. The study also revealed that children with unusually large heads are four times more likely to be diagnosed with Chiari 1 malformation than their peers with normal head circumference.

The findings, published Dec. 21 in the American Journal of Human Genetics, could lead to new ways to identify people at risk of developing Chiari 1 malformation before the most serious symptoms arise. It also sheds light on the development of the common but poorly understood condition.

A lot of times people have recurrent headaches, but they dont realize a Chiari malformation is the cause of their headaches, said senior author Gabriel Haller, PhD, an assistant professor of neurosurgery, of neurology and of genetics. And even if they do, not everyone is willing to have brain surgery to fix it. We need better treatments, and the first step to better treatments is a better understanding of the underlying causes.

If people start experiencing severe symptoms like chronic headaches, pain, abnormal sensations or loss of sensation, or weakness, the malformation is treated with surgery to decompress the Chiari malformation.

Theres an increased risk for Chiari malformations within families, which suggests a genetic underpinning, but nobody had really identified a causal gene, Haller said. We were able to identify two causal genes, and we also discovered that people with Chiari have larger head circumference than expected. Its a significant factor, and easy to measure. If you have a child with an enlarged head, it might be worth checking with your pediatrician.

To identify genes that cause Chiari 1 malformation, Haller and colleagues sequenced all the genes of 668 people with the condition, as well as 232 of their relatives. Of these relatives, 76 also had Chiari 1 malformation and 156 were unaffected. The research team included first author Brooke Sadler, PhD, an instructor in pediatrics, and co-authors David D. Limbrick, Jr., MD, PhD, a professor of neurosurgery and director of the Division of Pediatric Neurosurgery, and Christina Gurnett, MD, PhD, a professor of neurologyand director of the Division of Pediatric and Developmental Neurology, among others.

Sequencing revealed that people with Chiari 1 malformation were significantly more likely to carry mutations in a family of genes known as chromodomain genes. Several of the mutations were de novo, meaning the mutation had occurred in the affected person during fetal development and was not present in his or her relatives. In particular, the chromodomain genes CHD3 and CHD8 included numerous variants associated with the malformation.

Further experiments in tiny, transparent zebrafish showed that the gene CHD8 is involved in regulating brain size. When the researchers inactivated one copy of the fishs chd8 gene, the animals developed unusually large brains, with no change in their overall body size.

Chromodomain genes help control access to long stretches of DNA, thereby regulating expression of whole sets of genes. Since appropriate gene expression is crucial for normal brain development, variations in chromodomain genes have been linked to neurodevelopmental conditions such as autism spectrum disorders, developmental delays, and unusually large or small heads.

Its not well known how chromodomain genes function since they have such a wide scope of activity and they are affecting so many things at once, Haller said. But they are very intriguing candidates for molecular studies, to understand how specific mutations lead to autism or developmental delay or, as in many of our Chiari patients, just to increased brain size without cognitive or intellectual symptoms. Wed like to figure out the effects of each of these mutations so that in the future, if we know a child has a specific mutation, well be able to predict whether that variant is going to have a harmful effect and what kind.

The association between chromodomain genes and head size inspired Haller and colleagues to measure the heads of children with Chiari malformations, comparing them to age-matched controls and to population averages provided by the Centers for Disease Control and Prevention. Children with Chiari tended to have larger than average heads. Those children with the largest heads bigger than 95% of children of the same age were four times more likely to be diagnosed with the malformation.

The findings suggest that children with larger heads or people with other neurodevelopmental disorders linked to chromodomain genes may benefit from screening for Chiari malformation.

A lot of kids that have autism or developmental disorders associated with chromodomain genes may have undiscovered Chiari malformations, Haller said. The only treatment right now is surgery. Discovering the condition early would allow us to watch, knowing the potential for serious symptoms is there, and perform that surgery as soon as its necessary.

Reference: Rare and de novo coding variants in chromodomain genes in Chiari I malformation by Brooke Sadler, Jackson Wilborn, Lilian Antunes, Timothy Kuensting, Andrew T. Hale, Stephen R. Gannon, Kevin McCall, Carlos Cruchaga, Matthew Harms, Norine Voisin, Alexandre Reymond, Gerarda Cappuccio, Nicola Burnetti-Pierri, Marco Tartaglia, Marcello Niceta, Chiara Leoni, Giuseppe Zampino, Allison Ashley-Koch, Aintzane Urbizu, Melanie E. Garrett, Karen Soldano, Alfons Macaya, Donald Conrad, Jennifer Strahle, Matthew B. Dobbs, Tychele N. Turner, Chevis N. Shannon, Douglas Brockmeyer, David D. Limbrick, Christina A. Gurnett and Gabe Haller, 21 December 2020, American Journal of Human Genetics.DOI: 10.1016/j.ajhg.2020.12.001

This study was funded by Sam and Betsy Reeves and the Park-Reeves Syringomyelia Research Consortium; the University of Missouri Spinal Cord Injury Research Program; the Childrens Discovery Institute of St. Louis Childrens Hospital and Washington University; the Washington University Institute of Clinical and Translational Sciences, grant number UL1TR000448 from the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH); the Eunice Kennedy Shriver National Institute of Child Health & Human Development, award number U54HD087011 to the Intellectual and Developmental Disabilities Research Center at Washington University; the Swiss National Science Foundation, grant number 31003A_182632; and the Jrme Lejeune Foundation.

View original post here:
Common Brain Malformation Affecting About 1 in 100 Children Traced to Its Genetic Roots - SciTechDaily

Posted in Gene Medicine | Comments Off on Common Brain Malformation Affecting About 1 in 100 Children Traced to Its Genetic Roots – SciTechDaily

Global Cell Therapy Market Report 2020: Market to Recover in 2023 – PRNewswire

Posted: at 9:37 pm

DUBLIN, Dec. 31, 2020 /PRNewswire/ -- The "Cell Therapy Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's offering.

Cell Therapy Global Market Report 2020-30: COVID 19 Growth and Change provides the strategists, marketers and senior management with the critical information they need to assess the global cell therapy market.

Major players in the cell therapy market are Fibrocell Science Inc., JCR Pharmaceuticals Co. Ltd., PHARMICELL Co. Ltd., Osiris Therapeutics Inc., MEDIPOST, Vericel Corporation, Anterogen Co. Ltd., Kolon TissueGene Inc., Stemedica Cell Technologies Inc. and AlloCure.

The global cell therapy market is expected to decline from $7.31 billion in 2019 to $7.2 billion in 2020 at a compound annual growth rate (CAGR) of -1.54%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $10.0 billion in 2023 at a CAGR of 11.55%.

The cell therapy market consists of sales of cell therapy and related services. Cell therapy (CT) helps repair or replace damaged tissues and cells. A variety of cells are used for the treatment of diseases includes skeletal muscle stem cells, hematopoietic (blood-forming) stem cells (HSC), lymphocytes, mesenchymal stem cells, pancreatic islet cells, and dendritic cells.

North America was the largest region in the cell therapy market in 2019. Asia Pacific is expected to be the fastest-growing region in the forecast period.

The cell therapy market covered in this report is segmented by technique into stem cell therapy; cell vaccine; adoptive cell transfer (ACT); fibroblast cell therapy; chondrocyte cell therapy. It is also segmented by therapy type into allogeneic therapies; autologous therapies, by application into oncology; cardiovascular disease (CVD); orthopedic; wound healing; others.

In August 2019, Bayer AG, a Germany-based pharmaceutical and life sciences company, acquired BlueRock Therapeutics, an engineered cell therapy company, for $1 billion. Through this transaction, Bayer AG will acquire complete BlueRock Therapeutics' CELL+GENE platform, including a broad intellectual property portfolio and associated technology platform including proprietary iPSC technology, gene engineering, and cell differentiation capabilities. BlueRock Therapeutics is a US-based biotechnology company focused on developing engineered cell therapies in the fields of neurology, cardiology, and immunology, using a proprietary induced pluripotent stem cell (iPSC) platform.

The high cost of cell therapy hindered the growth of the cell therapy market. Cell therapies have become a common choice of treatment in recent years as people are looking for the newest treatment options. Although there is a huge increase in demand for cell therapies, they are still very costly to try. Basic joint injections can cost about $1,000 and, based on the condition, more specialized procedures can cost up to $ 100,000. In 2020, the average cost of stem cell therapy can range from $4000 - $8,000 in the USA. Therefore, the high cost of cell therapy restraints the growth of the cell therapy market.

Key players in the market are strategically partnering and collaborating to expand the product portfolio and geographical presence of the company. For instance, in April 2018, Eli Lilly, an American pharmaceutical company entered into a collaboration agreement with Sigilon Therapeutics, a biopharmaceutical company that focused on the discovery and development of living therapeutics to develop cell therapies for type 1 diabetes treatment by using the Afibromer technology platform. Similarly, in September 2018, CRISPR Therapeutics, a biotechnological company that develops transformative medicine using a gene-editing platform for serious diseases, and ViaCyte, a California-based regenerative medicine company, collaborated on the discovery, development, and commercialization of allogeneic stem cell therapy for diabetes treatment.

The rising prevalence of chronic diseases contributed to the growth of the cell therapy market. According to the US Centers for Disease Control and Prevention (CDC), chronic disease is a condition that lasts for one year or more and requires medical attention or limits daily activities or both and includes heart disease, cancer, diabetes, and Parkinson's disease. Stem cells can benefit the patients suffering from spinal cord injuries, type 1 diabetes, Parkinson's disease (PD), heart disease, cancer, and osteoarthritis.

According to Cancer Research UK, in 2018, 17 million cancer cases were added to the existing list, and according to the International Diabetes Federation, in 2019, 463 million were living with diabetes. According to the Parkinson's Foundation, every year, 60,000 Americans are diagnosed with PD, and more than 10 million people are living with PD worldwide. The growing prevalence of chronic diseases increased the demand for cell therapies and contributed to the growth of the market.

Key Topics Covered:

1. Executive Summary

2. Cell Therapy Market Characteristics

3. Cell Therapy Market Size And Growth 3.1. Global Cell Therapy Historic Market, 2015 - 2019, $ Billion 3.1.1. Drivers Of The Market 3.1.2. Restraints On The Market 3.2. Global Cell Therapy Forecast Market, 2019 - 2023F, 2025F, 2030F, $ Billion 3.2.1. Drivers Of The Market 3.2.2. Restraints On the Market

4. Cell Therapy Market Segmentation 4.1. Global Cell Therapy Market, Segmentation By Technique, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.2. Global Cell Therapy Market, Segmentation By Therapy Type, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.3. Global Cell Therapy Market, Segmentation By Application, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

5. Cell Therapy Market Regional And Country Analysis 5.1. Global Cell Therapy Market, Split By Region, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion 5.2. Global Cell Therapy Market, Split By Country, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/rblnmb

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

Read more from the original source:
Global Cell Therapy Market Report 2020: Market to Recover in 2023 - PRNewswire

Posted in Gene Medicine | Comments Off on Global Cell Therapy Market Report 2020: Market to Recover in 2023 – PRNewswire

Vertex Announces New Drug Submission for Investigational Triple Combination Medicine for the Treatment of Cystic Fibrosis Has Been Accepted for…

Posted: at 9:37 pm

Dec. 28, 2020 13:04 UTC

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced its New Drug Submission for TRIKAFTA, Vertexs investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in people ages 12 years and older.

We are pleased this submission has been accepted for Priority Review by Health Canada, and we anticipate this accelerated review process will enable access for patients as early as possible, said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex.

With Priority Review, the conventional review timeline of 300 days is reduced to 180 days. The expected approval target by Health Canada is in the first half of 2021.

About Cystic Fibrosis

Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes one from each parent to have CF. While there are many different types of CFTR mutations that can cause the disease, the vast majority of all people with CF have at least one F508del mutation. These mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working and/or too few CFTR proteins at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create medicines for people with serious diseases. The company has multiple approved medicines that treat cystic fibrosis (CF) a rare, life- threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 11 consecutive years on Science magazine's Top Employers list and a best place to work for LGBTQ equality by the Human Rights Campaign. For company updates and to learn more about Vertexs history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Carmen Bozic in this press release, including expectations for patient access to our medicine, and statements regarding the anticipated timing of the expected approval target by Health Canada. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that the New Drug Submission to Health Canada may not be approved in the expected timeline, or at all, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under the heading Risk Factors in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at http://www.sec.gov and available through the company's website at http://www.vrtx.com. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

View source version on businesswire.com: https://www.businesswire.com/news/home/20201228005171/en/

Go here to see the original:
Vertex Announces New Drug Submission for Investigational Triple Combination Medicine for the Treatment of Cystic Fibrosis Has Been Accepted for...

Posted in Gene Medicine | Comments Off on Vertex Announces New Drug Submission for Investigational Triple Combination Medicine for the Treatment of Cystic Fibrosis Has Been Accepted for…

LYNPARZA (olaparib) Receives Three New Approvals in Japan – Business Wire

Posted: at 9:37 pm

KENILWORTH, N.J.--(BUSINESS WIRE)--AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that LYNPARZA has been approved in Japan for the treatment of three types of advanced cancer: ovarian, prostate and pancreatic cancer. The three approvals authorize LYNPARZA for use as maintenance treatment after first-line chemotherapy containing bevacizumab (genetical recombination) in patients with homologous recombination repair deficient (HRD) ovarian cancer; the treatment of patients with BRCA gene-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC); and maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.

The concurrent approvals by the Japanese Ministry of Health, Labor, and Welfare are based on results from the PAOLA-1, PROfound and POLO Phase 3 trials, which each were published in The New England Journal of Medicine.

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, These three approvals allow patients in Japan to be treated with LYNPARZA, a targeted treatment personalized to their specific biomarkers. They further underline the critical importance of biomarker testing at diagnosis, which helps physicians determine a course of treatment tailored to their individual patients to substantially delay disease progression.

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, For patients in Japan diagnosed with each of these types of cancer, there are very few treatment options. Approvals for treatments such as LYNPARZA, the first PARP inhibitor to be approved in these specific types of metastatic castration-resistant prostate cancer and metastatic pancreatic cancer in Japan, enable us to advance this evolving era of personalized medicine and change how these cancers are treated.

LYNPARZA Approved as Maintenance Treatment After First-Line Chemotherapy Containing Bevacizumab (Genetical Recombination) in Patients with HRD-Positive Ovarian Cancer

The approval is based on a biomarker subgroup analysis of the PAOLA-1 Phase 3 trial which showed LYNPARZA, in combination with bevacizumab maintenance treatment, demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer.

In 2020, nearly 11,000 women in Japan were diagnosed with ovarian cancer, with more than 5,000 women dying of the disease.

LYNPARZA Approved for the Treatment of BRCAm Castration-Resistant Prostate Cancer with Distant Metastasis

The approval is based on a subgroup analysis of the PROfound Phase 3 trial which showed LYNPARZA demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1/2 mutations. LYNPARZA is the first and only PARP inhibitor approved in Japan in mCRPC.

Prostate cancer is the third most common type of cancer in Japan and in 2020, accounted for over 100,000 new cases.

LYNPARZA Approved as Maintenance Treatment After Platinum-Based Chemotherapy for Patients with BRCAm Curatively Unresectable Pancreas Cancer

The approval is based on the results of the POLO Phase 3 trial which showed LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in PFS versus placebo in patients with gBRCAm metastatic pancreatic cancer. LYNPARZA is the first and only PARP inhibitor approved in Japan in this disease.

Pancreatic cancer has one of the lowest survival rates of the most common cancers and in Japan was responsible for almost 40,000 deaths in 2020 the fourth most common cause of cancer death. Japan has the third-highest rate of pancreatic cancer in the world with 44,000 new cases diagnosed in 2020.

AstraZeneca and Merck are exploring additional trials in advanced prostate cancers including the ongoing PROpel Phase 3 trial testing LYNPARZA as a first-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021. Outside the collaboration, Merck is exploring additional trials in advanced ovarian cancer including the Phase 3 KEYLYNK-001 trial evaluating KEYTRUDA in combination with chemotherapy, followed by maintenance LYNPARZA, for the first-line treatment of women with BRCA non-mutated advanced ovarian cancer.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

Venous Thromboembolic Events: Including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.

ADVERSE REACTIONSFirst-Line Maintenance BRCAm Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/ nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONSFirst-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

Most common adverse reactions (Grades 1-4) in 10% of patients treated with LYNPARZA/bevacizumab compared to a 5% frequency for placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%) and leukopenia (18%). In addition, the most common adverse reactions (10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%).

ADVERSE REACTIONSMaintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in clinical trials of LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONSAdvanced gBRCAm Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue/asthenia (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), mean corpuscular volume elevation (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONSgBRCAm, HER2-negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in >25% of patients in OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

ADVERSE REACTIONSFirst-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONSHRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr 30 mL/min).

INDICATIONS in the US

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance HRD Positive Advanced Ovarian Cancer in Combination with Bevacizumab

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Maintenance Recurrent Ovarian Cancer

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Advanced gBRCAm Ovarian Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

gBRCAm HER2-negative Metastatic Breast Cancer

For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

HRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

About PAOLA-1

PAOLA-1 is a double-blind Phase 3 trial testing the efficacy and safety of LYNPARZAadded to standard-of-care bevacizumab versus bevacizumab alone, as a first-line maintenance treatment for newly diagnosed advanced (FIGO stages III and IV) high-grade serous or endometroid ovarian, fallopian tube or peritoneal cancer patients who had a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab.

The PAOLA-1 Phase 3 trial showed that LYNPARZA, in combination with bevacizumab maintenance treatment, reduced the risk of disease progression or death by 67% (HR 0.33 [95% CI, 0.25-0.45]) in patients with HRD-positive advanced ovarian cancer. The addition of LYNPARZA improved PFS to a median of 37.2 months vs. 17.7 months with bevacizumab alone.

The most common adverse reactions (ARs) 10% in the overall trial population for PAOLA-1 when treated with LYNPARZA in combination with bevacizumab (N=535) and at a 5% frequency compared to bevacizumab alone (N=267) were fatigue (53% vs. 32%), nausea (53% vs. 22%), anemia (41% vs. 10%), lymphopenia (24% vs. 9%), vomiting (22% vs. 11%) and leukopenia (18% vs. 10%). Grade 3 or above ARs were anemia (17% vs. <1%), lymphopenia (7% vs. 1%), fatigue (5% vs. 2%), nausea (2% vs. 1%), leukopenia (2% vs. 2%) and vomiting (2% vs. 2%). Additional ARs that occurred in 10% of patients receiving LYNPARZA in combination with bevacizumab irrespective of the frequency compared to bevacizumab alone were diarrhea (18%), neutropenia (18%), urinary tract infection (15%) and headache (14%). Fatal ARs occurred in one patient due to concurrent pneumonia and aplastic anemia. Serious ARs occurred in 31% of patients who received LYNPARZA in combination with bevacizumab. Serious ARs in >5% of patients included hypertension (19%) and anemia (17%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA in combination with bevacizumab (5%) than in those receiving bevacizumab alone (1.9%). ARs led to dose interruption in 54% of patients on LYNPARZA in combination with bevacizumab, while 41% of patients on LYNPARZA in combination with bevacizumab had a dose reduction. Discontinuation of treatment due to ARs occurred in 20% of patients on LYNPARZA in combination with bevacizumab.

About PROfound

PROfound is a prospective, multi-center, randomized, open-label Phase 3 trial testing the efficacy and safety of LYNPARZA versus enzalutamide or abiraterone in patients with mCRPC who have progressed on prior treatment with a new hormonal anticancer treatment and have a qualifying tumor mutation in BRCA1/2, ATM or one of 12 other genes involved in the HRR pathway.

The trial was designed to analyze patients with HRR-mutated genes in two cohorts: the primary endpoint was in those with mutations in BRCA1/2 or ATM genes and then, if LYNPARZA showed clinical benefit, a formal analysis was performed of the overall trial population of patients with HRR-mutated genes.

The subgroup analysis from the PROfound Phase 3 trial showed LYNPARZA reduced the risk of disease progression or death by 78% (HR 0.22 [95% CI, 0.15-0.32], nominal p<0.0001) and improved rPFS to a median of 9.8 months vs. 3.0 months with enzalutamide or abiraterone in men with mCRPC with BRCA1/2 mutations. LYNPARZA reduced the risk of death by 37% (HR 0.63 [95% CI 0.42-0.95]) with median OS of 20.1 months vs. 14.4 months with enzalutamide or abiraterone. The OS results from the PROfound Phase 3 trial were published in The New England Journal of Medicine earlier this year.

The most common ARs in the PROfound trial, occurring in 10% of subjects, for LYNPARZA compared to enzalutamide or abiraterone were anemia (46% vs.15%), nausea (41% vs. 19%), fatigue (including asthenia) (41% vs. 32%), decreased appetite (30% vs. 18%), diarrhea (21% vs. 7%), vomiting (18% vs. 12%), thrombocytopenia (12% vs. 3%), cough (11% vs. 2%) and dyspnea (10% vs. 3%). Dose interruptions due to an AR occurred in 45% of patients receiving LYNPARZA and dose reductions due to an AR occurred in 22% of LYNPARZA patients. Discontinuation due to ARs occurred in 18% of LYNPARZA patients.

About POLO

POLO is a randomized, double-blinded, placebo-controlled, multi-center trial of LYNPARZA tablets (300 mg twice daily) as maintenance monotherapy versus placebo. The trial randomized 154 patients with gBRCAm metastatic pancreatic cancer whose disease had not progressed on first-line platinum-based chemotherapy. Patients were randomized (3:2) to receive LYNPARZA or placebo until disease progression. The primary endpoint was PFS and key secondary endpoints included OS, time to second disease progression, overall response rate and health-related quality of life.

Data from the Phase 3 POLO trial showed LYNPARZA nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo and reduced the risk of disease progression or death by 47% (HR 0.53 [95% CI, 0.35-0.82], p=0.0035).

The most common ARs 10% were fatigue/asthenia (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%). The most common grade 3 ARs were anemia (11%), fatigue/asthenia (5%), decreased appetite (3%), abdominal pain (2%), vomiting (1%) and arthralgia (1%). Among patients taking LYNPARZA, dose interruptions due to an AR of any grade occurred in 35% and dose reductions due to an AR occurred in 17%. Discontinuation due to ARs occurred in 6% of patients receiving LYNPARZA.

About LYNPARZA (olaparib)

LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.

About BRCA Mutations

BRCA1 and BRCA2 (breast cancer susceptibility genes 1/2) are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

About Homologous Recombination Deficiency

HRD encompasses a wide range of genetic abnormalities, including BRCA mutations, that can be detected using tests. As the BRCA gene drives DNA repair via homologous recombination, mutation of this gene leads to homologous recombination deficiency thereby interfering with normal cell DNA repair mechanisms. BRCA mutations are just one of many HRDs which confer sensitivity to PARP inhibitors including LYNPARZA.

About the AstraZeneca and Merck Strategic Oncology Collaboration

Read more:
LYNPARZA (olaparib) Receives Three New Approvals in Japan - Business Wire

Posted in Gene Medicine | Comments Off on LYNPARZA (olaparib) Receives Three New Approvals in Japan – Business Wire

COVID-19 roundup: Higher viral load in UK variant, early antibodies key to recovery | Daily Sabah – Daily Sabah

Posted: at 9:37 pm

This week's roundup of some of the latest scientific studies on the coronavirus and efforts to find treatments and vaccines for COVID-19 reveals that a new variant circulating in the U.K. and Europe could spell trouble if its viral load is as high as in collected samples, while stressing that the early production of antibodies may offer a better chance at recovery rather than the amount produced.

U.K. coronavirus variant associated with higher viral loads

The highly infectious COVID-19 coronavirus variant that has been circulating in Britain is linked to higher loads of the virus in swab samples obtained from the nose and the back of the throat, according to a research report published on medRxiv ahead of peer review.

Around 35% of patients infected by the variant form had very high levels of the virus in their samples, compared to 10% of patients without the variant, study leader Michael Kidd of Public Health England and Birmingham University told Reuters. Higher viral loads have been linked with worse COVID-19 outcomes. The tests were conducted at the Birmingham Turnkey Lab.

Kidd said an additional study was needed to confirm or refute the findings. If confirmed, he hopes scientists will investigate how this particular variant manages to make more copies of itself in infected patients.

Early antibody production key to COVID-19 recovery

The speed of patients' antibody production rather than the volume of antibodies they produce to fight the new coronavirus determines whether they will survive COVID-19, new data suggests.

Researchers who studied more than 200 COVID-19 patients, including 179 who were hospitalized, found those who produced so-called neutralizing antibodies within 14 days of developing symptoms eventually recovered, while those who did not produce neutralizing antibodies until more than 14 days had elapsed developed higher viral loads and more severe disease.

"It is unclear why antibodies generated after this time point are unable to promote viral clearance and recovery in COVID-19 patients," the researchers said in a report posted on medRxiv ahead of peer review. Study leader Akiko Iwasaki of the Yale University School of Medicine tweeted on Saturday, "It's possible that virus somehow becomes resistant by hiding in inaccessible tissues."

The new findings, she added, suggest therapy with so-called monoclonal antibody drugs such as those from Regeneron given to U.S. President Donald Trump is likely to work only if used soon after infection.

Masked faces not a complete mystery to children

Young children can sometimes read the emotions of adults who are wearing face masks, according to a new study.

Researchers asked 81 children, aged 7 to 13, to assign one of six emotions to photographs of faces that were either unobstructed, covered by a surgical mask, or wearing sunglasses. The children correctly identified the emotions in 66% of the uncovered faces. When faces were masked, they correctly identified sadness 28% of the time and anger 27% of the time, the researchers reported in PLoS One. Sunglasses made some emotions harder to identify.

"Emotions aren't conveyed solely through your face," coauthor Ashley Ruba of the University of Wisconsin-Madison said in a statement. "Vocal inflections, the way that someone positions their body, and what's going on around them, all that other information helps us make better predictions about what someone is feeling."

Neanderthal gene protects against COVID-19

A specific form of a protein passed down from Neanderthals protects against severe COVID-19, and medications that boost levels of this protein could potentially help treat the disease, according to a study reported on medRxiv ahead of peer review.

The protein, called OAS1, is involved in the body's response to viruses. People with higher levels of the Neanderthal-related form of OAS1 are less susceptible to COVID-19, and if they do become infected, they are at lower risk for hospitalization, intubation and death, the researchers found.

"This protective form of OAS1 is present in sub-Saharan Africans but was lost when the ancestors of modern-day Europeans migrated out of Africa. It was then reintroduced into the European population through mating with Neanderthals" who lived more than 40,000 years ago, said co-author Brent Richards from the Jewish General Hospital and McGill University in Montreal.

An earlier study linked a cluster of genes inherited from Neanderthals to higher risks of hospitalization from COVID-19. "These findings further implicate Neanderthal ancestry in COVID-19 severity," Richards said.

See the original post here:
COVID-19 roundup: Higher viral load in UK variant, early antibodies key to recovery | Daily Sabah - Daily Sabah

Posted in Gene Medicine | Comments Off on COVID-19 roundup: Higher viral load in UK variant, early antibodies key to recovery | Daily Sabah – Daily Sabah

Five things the Legislature can do to make Pennsylvanians’ lives measurably better in 2021 | John L. Micek – Pennsylvania Capital-Star

Posted: January 1, 2021 at 10:03 am

In just a few days, lawmakers in the state House and Senate will be sworn into office, kicking off a two-year legislative session that, if past is prologue (and it almost always is), will be replete with bridge and bypass renamings, votes to declare June the official month of something-or-other, and plenty of partisan sound and fury signifying nothing much at all.

But if 2020, for all its horror, pain, trauma and frustration taught us anything at all, its that government, when it functions at its best, can move swiftly and reasonably efficiently to do the most good for the largest number of people.

As I observed back in April, congressional authorization of the CARES Act was an affirmation that government can move affirmatively to make peoples lives measurably better. And once that door was thrown open, there are fewer excuses not to do it again.

Its also a truism that the Legislature, whose mitts are in almost every sector of life here in the Commonwealth, is best-positioned to improve the lives of nearly 13 million Pennsylvanians as the level of government thats closest to the people.

And, as my friend and colleague Jan Murphy, of PennLive, reported earlier this week, lawmakers did just that, as they enacted a law cracking down on human trafficking, among other measures. As the Capital-Stars Stephen Caruso reported back in July, lawmakers also approved, and Gov. Tom Wolf signed, a suite of police training and hiring reforms that were a first step on a much longer road.

So as the 203 members of the House and 50 members of the Senate get ready to return to work in 2021, here are a few modest suggestions on how they can best channel their energies to do the maximum amount of good right away.

Republicans who control the General Assembly spent much of 2020 squabbling with the Wolf administration over its pandemic management policies. By years end, that squabbling had devolved into a series of pointless and time-wasting veto override votes and mask-less and symbolic rallies that failed to produce measurable change. And given the choice during Novembers budget debate, lawmakers who pleaded for assistance to business owners socked by the pandemics economic ravages, instead opted to spend the states remaining $1.3 billion in CARES Act money to backfill state police, corrections officers and public health employees salaries, the Capital-Stars Stephen Caruso reported at the time.

In December, Democrats in the state Senate rolled out an ambitious, $4 billion, debt-funded relief proposal that would, among other things, provide nearly $2 billion in enhanced unemployment benefits and aid to businesses. A few weeks later, two Democratic lawmakers in the state House proposed a $200 million grant program, funded through the states Rainy Day Fund, for restaurant and bar owners struggling under the weight of indoor dining restrictions and rising case loads.

While its true that Congress has approved, and President Donald Trump has signed, a $900 billion stimulus program, lawmakers should treat that federal action as the beginning, rather than the end, of the good they can do for Pennsylvania.

Republicans have spent much of the past six weeks bleating about non-existent fraud in races that not only saw them safely re-elected, but also resulted in GOP wins in two of the three statewide row offices. Imagine if they put as much energy into solving a problem that actually exists.

Pennsylvania hasnt executed anyone since Philadelphia torture-killer Gary Heidnik went willingly to the death chamber in 1999. A moratorium on executions imposed during the first year of Gov. Tom Wolfs administration brought the states already grinding and expensive machinery of death to a complete halt. And as a new report by the Death Penalty Information Center makes clear, executions nationwide fell to historic lows during the pandemic as public opinion continued to turn against societys ultimate sanction. And policymakers listened. Colorado, for instance, became the 22nd state to abolish capital punishment, this year.

There is no question now that the death penalty is racist and classist, with with almost half the defendants executed in 2020 being people of color, and 76 percent of the executions were for the deaths of white victims. There is also a profound innocence problem, as the DPIC report makes clear: Five people were exonerated from death row in 2020, bringing the number of people exonerated from death row to 172 since 1973. In each of the five cases, prosecutorial misconduct contributed to the wrongful conviction, researchers found.

Last session, the unlikely pair of Rep. Chris Rabb, a Black progressive from Philadelphia, and Frank Ryan, a white conservative from Lebanon County, partnered on an abolition bill. Capital punishment remains the last criminal justice reform blindspot in a General Assembly that has taken some admirable steps to fix a broken system. For all practical purposes, Pennsylvania does not have the death penalty. There should be no issue, save for a lack of political courage, in getting rid of a non-functioning statute.

I mean, cmon, if New Jersey can do it and itll give Lt. Gov. John Fetterman one less thing to tweet about. Senate Republicans could take that, and the roughly $600 million in revenue gleaned from legalization, and declare a win.

Quick can you rattle off the names of the appellate judges you voted for in 2019? Can you even name four members of Pennsylvanias Superior or Commonwealth Courts? Im guessing no which just underlines the inanity of our current system of electing judges, which forces allegedly impartial jurists to raise money and wage nearly information-free campaigns for office, where the real beneficiaries are members of the trial bar and deep-pocketed corporate interests and not the voters.

Now, theres real movement afoot to make a bad system even worse with a GOP-backed effort to amend the state constitution to elect judges by region, rather than statewide. Critics warn that such a change would result in a dangerously politicized court system, WHYY-FM reported this week.

The lack of strict mapping criteria, in the proposal, or any protections for racial and language minorities combined with a total lack of transparency in the mapping process amounts to an open invitation to legislators to engage in partisan gerrymandering in order to increase the likelihood that candidates of their political party will be elected to the courts, Patrick Beaty, of the good government group Fair Districts PA, wrote in a Dec. 6 op-Ed for the Capital-Star.

If lawmakers are going to expend the energy on the rightfully difficult process of amending the states foundational document, their attention would be better directed to a proposal by Senate Judiciary Committee Chairwoman Lisa Baker, R-Luzerne, that would open a two-year window for civil litigation filed by the adult survivors of childhood sexual abuse. The proposed amendment won approval in the House and Senate in this years legislative session. Another round of approval in the 2021 session would put it before the voters as early as next springs primary election.

If the intent is to do the most good for the most people, Bakers proposed amendment, which would impact thousands of people statewide, is the obvious priority over a nakedly political amendment that no one, save partisans and special interests, is crying out to have passed.

Ive always been a huge fan of Hubert Humphreys maxim that the moral test of government is how that government treats those who are in the dawn of life, the children; those who are in the twilight of life, the elderly; and those who are in shadows of life, the sick, the needy, and the handicapped.

So even as many Pennsylvania school districts struggled to tame rising pension costs and deal with stagnant tax revenues, the state also saddled them with shouldering the rising cost of educating students living with disabilities without giving them the financial assistance to handle it, a new report concludes.

The states 501 school districts boosted their special education spending by $2 billion between 2009 and 2019, but state aid during that same period grew by just $110 million, concludes the Dec. 3 report by the Education Law CenterandPA Schools Work, citing the most recent state data.

The state budget approved in November includes more than $1.1 billion in funding for special education programs. Because of the pandemic, the line item is funded at the same level as it was in the 2019-20 fiscal year.

Advocateshave complained for years that the state is underfunding special education, and have called for the funding formula to be updated to provide a more level playing field for students with special needs.

In 2019, a joint analysis by theEducation Law CenterandResearch for Action, a policy research group in Philadelphia, concluded that the formula does not accurately account for district poverty. As a result, state special education funding does not fulfill its intended purpose of addressing funding disparities resulting from differences in local wealth.

Analysts argued that the state neededannual funding increases of $100 million a year or more to keep pace with rising costs. This is a debate that should be moved to the front of the queue in 2021.

As I also noted in April, merely reopening after the pandemic isnt enough. This new time calls for a reset on everything. The dawning of a new year offers just such an opportunity. The 253 members of the General Assembly should not squander it.

Original post:

Five things the Legislature can do to make Pennsylvanians' lives measurably better in 2021 | John L. Micek - Pennsylvania Capital-Star

Posted in Abolition Of Work | Comments Off on Five things the Legislature can do to make Pennsylvanians’ lives measurably better in 2021 | John L. Micek – Pennsylvania Capital-Star

FUTURE GAZING: We Need True Lovers – southseattleemerald.com

Posted: at 10:03 am

With a challenging year soon to be behind us, we asked community members to share their vision of what they hope becomes of our city post-pandemic.

by C. Davida Ingram

This year has kicked my ass and cracked my heart open. These are not bad things. Its not about me. Its time. Ours. The U.S. has led in COVID deaths because we lead by oppression. Imagine if we could ever think beyond capitalism, misogyny, racism, and rapaciousness. Imagine if we gave ourselves breathing room and a fighting chance.

COVID keeps asking us to care. Its asking on behalf of our elders, children, health care workers, parents and caregivers, educators, essential workers, and our larger society.

We moralized AIDS, the last pandemic. We cant moralize breathing. I guarantee you use your lungs more promiscuously than youll ever use your genitals. We all breathe the same air. The conditions in our Department of Corrections sites, nursing homes, hospitals, farms, and far too many precariously held homes tell us we need new ways. Right now, millions of people are losing their homes, or cant pay rent, or did not have stable housing to begin with. Yet, we are the richest country on the Earth.

The vivid object lesson of COVID is liberation. Period. Thats a beautiful thing.

It leaves us with the provocation of imagining being a real Lover. Im not talking cheap romance but rather a world where everyone is valued. We need true Lovers. People who love people. People who believe we all need space to hone and share our gifts. People who are nurtured and give that same care in return.

Greed, prisons, the breaking of families (of all kinds), violation of dignity, ignorance are so obscene and so clear to see in this pandemic and its display of dehumanizations. Meanwhile, so many different dreamers are awakening, murmuring maybe we can cherish one another instead. I like listening to their song.

C. Davida Ingram is an award-winning artist and civic leader based in Seattle, Washington who believes in liberation, abolition, and mutual aid. Her artwork, curatorial projects, and writing discuss race and gender via lens-based media, social practice, performance art, lyrical essay and installation art. In 2014, Ingram received the 2014 Stranger Genius Award in Visual Arts. In 2016, she became a Kennedy Center Citizen Artist Fellow. In 2018, she was awarded the Jacob Lawrence Legacy Residency at the University of Washington. Seattle Magazine has voted Ingram both one of the 20 most talented people in Seattle (2016) and one of Seattles most influential people (2017). Her art is part of the collections of the City of Seattle, the Tacoma Art Museum, the Frye Art Museum, and private collections. You can find her work @idebelle76 on Twitter and Instagram.

Illustration by Alexa Strabuk

Like Loading...

Link:

FUTURE GAZING: We Need True Lovers - southseattleemerald.com

Posted in Abolition Of Work | Comments Off on FUTURE GAZING: We Need True Lovers – southseattleemerald.com

‘The hallmark of a caring community’ – Johnston Sun Rise

Posted: at 10:02 am

By J. MICHAEL LEVESQUE

No one needs to be convinced that this has been a terrible year.

The doomsday virus that originated in the Peoples Republic of China (otherwise known as COVID-19) has spread death and destruction throughout the globe.

Most of us have personal stories of relatives or friends who have perished as a result of the virus, and all of us have witnessed the devastation of our economy, resulting in people losing their homes, businesses and their livelihoods.

People simply dont know where to turn.

And in the midst of all of this heartache, we had to witness a hyper-partisan election that exacerbated the problem with riots in our cities and attacks on the very fabric of our lives, including the lunacy of the calls for the abolition and defunding of our police departments, at a time when we need them the most.

It is clearly a time that tests our resolve as a community and a nation.

And a time when we need the holidays the most, when people naturally bind together to help those in need.

We need to look no further than the city of Warwick, the home of arguably the start of the American Revolution when Abraham Whipple and the boys burned His Majestys Ship The Gaspee in 1772, to once again see the power of what people can do to help their community.

It is against this backdrop of the pandemic and the calls to abolish and defund the police that Jennifer Rathbun, who is married to Warwick Police Chief Rick Rathbun, formed the Warwick Police Department Family Group to start helping family members of not only Warwick Police officers, but families in the community as well.

She initially contacted the National Police Wives Association and was encouraged to reach out to families of our department knowing that with all the unrest in the community, we really didnt feel connected.

There was a sense of isolation that we felt, according to Rathbun.

She also reached out to the Rhode Island Chapter of the National Police Wives Association, which is comprised of about 400 family members representing departments throughout the state.

Ms. Rathbun also noticed that many law enforcements family peer support groups are geared toward spouses, primarily wives, and thought that the focus in Warwick should be on families, and not just on officers and their spouses.

Family members are in service alongside their officers, but not everyone is married and support systems often include parents, siblings and adult children, she said.

So, with the strong support of her husband she reached out with an inclusive invitation to join together and launched the WPD Family Group this past summer.

The group set up a private social media page, and for people not accustomed to social media, created connections through email.

It didnt take long for the membership to grow to over 40 people and they quickly started to engage with the department and the community.

They reached out to WPD Community Services Division Capt. Michael Lima and started to coordinate with his division, which covers everything from community policing to school resource officers and mental health needs.

They together outlined some upcoming projects to work on, starting with the highly successful Thanksgiving Food Drive at markets throughout the city, where people could stuff a police cruiser parked outside the stores with food for needy families.

It was so successful that according to Capt. Lima, they had to replace the police cruisers with vans.

But on a sad note, they also found it difficult to see the unprecedented need caused by the pandemic. They were told that over 150 people a day stood in line for the donations.

That help was most welcomed by West Bay Community Action.

According to Lima, their shelves were bare. Words couldnt do justice to the joy that was created (with the donations). Things might be good for us, but not for other people.

I brought my kids along to show how people need our help. It teaches all of us a lesson, he said.

Not resting on their laurels, the group then turned their efforts to helping families cope during the Christmas season.

Using the same model to stuff a cruiser to provide needy families with toys and clothes for their children, volunteers gave up many weekends to stand outside several businesses to solicit donations.

In all, hundreds of families were helped in a time when they needed it the most.

A time when many families were put in a position that they never dreamed that they would be in.

But food drives and toy drives are not the only thing that the group does.

It also helps police families in a variety of ways, sometimes with emotional support, and sometimes with the little things that can make all the difference in the world, from sharing mental health resources, or a bit of humor, to providing a safe sounding board for shared concerns. The group also lobbies Rhode Island elected officials with letter writing campaigns in support of pro-law enforcement legislation.

They also turn inward to support the department by participating in efforts such as the National Thank a Police Officer Day in September.

According to Jennifer, many of our officers do things quietly, things that never make the papers. Like the officer who came into contact with a senior citizen who did not have any food in his home and went into a nearby store to buy him some with his own money, or another who saw a family whose children had no warm clothing. So, she went into a store and bought them some, again with her own money.

Jennifer Rathbun sees it this way: Its not really the role of the police department to run food drives and toy drives. But we know that when people are struggling to meet basic needs, that can lead to a sense of desperation. And nothing good comes from hopelessness.

She continued: If we can provide some hope in a way that helps to humanize the badge by being bridge-builders within the community, then thats a good thing for us to support. And the generosity of the public that has been reflected back towards the police departments efforts to help those in need is truly the hallmark of a caring community.

She added: We keep hearing that the holidays are going to be different this year. It turns out that kindness is still the answer, at least in Warwick where the Police Department and their family members behind the scenes take pride in leading with love for their neighbors and thats truly the spirit of Christmas in action!

Cant add much to those eloquent words.

And from the Levesque family to yours our wishes for a very Merry Christmas and a better 2021.

J. Michael Levesque, a Warwick resident, is a former mayor of West Warwick and contributor to these newspapers.

Read the rest here:

'The hallmark of a caring community' - Johnston Sun Rise

Posted in Abolition Of Work | Comments Off on ‘The hallmark of a caring community’ – Johnston Sun Rise

Bringing Traditional Healing Under the Microscope in South Africa – Medscape

Posted: at 10:02 am

Traditional healer and national coordinator of the Traditional Healers Organisation (THO) of South Africa, Phephisile Maseko, treats patients with a mix of cannabis and other herbs.

In June, Artemisia afra was in high demand on the streets of Johannesburg in South Africa. To treat Covid-19 symptoms, the Indigenous herb's silvery leaves were for sale at roadside vendors and in the city's popular traditional markets. Some people even pulled the plant from private gardens. And on the sides of nearby highways, people held signs for "mhlonyane" (A. afraisi the Zulu name) and offered bushels to passing motorists like bouquets. Between February and July, the herb doubled in price.

People in the region have consumed the bitter plant for centuries to treat illnesses from colds to intestinal worms. With deaths rising as South Africa battled its first Covid-19 wave, people have turned to A. afra and other traditional medicines, including cannabis. (They were not the only ones. In April, Madagascar's president, Andry Rajoelina, had launched Covid-Organics, a herbal concoction containing another artemisia species, A. annua, which he claimed without evidence could cure Covid-19.)

As with most traditional medicine in South Africa a broad category that relies on a variety of herbs, rather than the refined molecules of Western drugs there is no robust, peer-reviewed evidence that A. afra has any utility against any ailment, including Covid-19. Local medical doctors and officials have cautioned the public against using the plant instead of seeking medical attention for Covid-19, and the World Health Organization (WHO) has similarly urged people to avoid using untested medicines to treat the disease. But that has not stopped demand for A. afra and that demand now has some mainstream health advocates calling for greater scrutiny of traditional remedies including submitting them to clinical trials.

Whether this will come to pass is far from clear. Despite South Africa having a large number of practicing traditional healers and millions of mostly Black South Africans who use their medicines, traditional health care practices stand well outside of mainstream health care in the country. Although there have been efforts to regulate traditional healers, their remedies, for the most part, have not been subjected to scientific scrutiny. This is in part due to South Africa's history. While people in the region have used traditional medicines for millennia, in 1957, the racist apartheid regime suppressed traditional healing through the Witchcraft Suppression Act, labeling many of its practices as criminal offenses and forcing it underground. There is also a long history elsewhere in the world of scientists and companies turning Indigenous knowledge into Western medicines, and many stakeholders fear that, once healers divulge their secrets and methods to expose their therapies to the rigor of clinical trials, this will happen again with South African traditional medicine.

Indeed, many herbal remedies are closely guarded secrets, intertwined with a philosophy in which health is inextricably linked with spiritual life. And unlike other ancient health care systems that rely on written texts, African healers share and preserve knowledge largely through oral tradition, so there is little record of how the medicines were made and used hundreds of years ago. This lack of ingredient information and recorded longitudinal safety data make African traditional medicines particularly difficult to test.

If you want to push biodiversity or African traditional medicine, you have to conduct a clinical trial," says Chibale.

Still, the WHO and the Africa Center for Disease Control and Prevention, in collaboration with the Developing Countries Clinical Trial Partnership (EDCTP), have developed guidelines to evaluate the medicines' safety and efficacy against Covid-19. And while some experts lobbying for more scrutiny of traditional medicine noted that South Africa's drug regulators have been historically antagonistic to the idea, the unprecedented Covid-19 pandemic may well be helping to change all that. Indeed, government overseers have established a special unit to evaluate these traditional products, and while answers may come too slowly to address Covid-19, the investigations may have long-lasting implications. "Covid has been a game changer for traditional medicine," said Nceba Gqaleni, a traditional medicines specialist at the Africa Health Research Institute in Durban, adding that the Covid-19 treatments haven't faced some of the same controversies as past traditional medicines especially therapies for HIV/AIDS.

A. afra is one of a number of herbs that the government is investigating against Covid-19. In July, officials set up the African Medicines Covid-19 Research Team, which includes scientists and traditional healers, and diverted about R15-million (at the time equaling about $880,500) from existing Indigenous knowledge projects to fund the collaboration.

The project could lead to other research outside of Covid-19, since the country is home to 10 percent of the world's plant species and remains a largely untapped pharmaceutical resource. Nox Makunga, a medicinal botanist at Stellenbosch University, says that since the abolition of apartheid, the South African government has been expressed eagerness to investigate and develop effective herbal medicines. "They see it as 'green gold,'" she said. But that hasn't yet come to fruition. In 2008, the government published a draft policy for traditional medicines, which was subsequently shelved, and while South Africa's 2013 Bioeconomy Strategy laid out ambitious plans to investigate herbal cures, the country has not yet managed to formally evaluate traditional medicines or discover any new drugs based on their constituents.

The Covid-19 pandemic may be providing new impetus for such efforts, but experts say it won't happen without compromises.

Plants used in traditional medicine are sold at popular markets, like the Faraday Muti Market in downtown Johannesburg.

Modern medicine, of course, hinges on the ability to show that any particular compound be it from nature or synthetically-derived is effective and safe at an established dose. Such demonstrations are generally obtained through clinical trials, and while the process is not without shortcomings, it has generally yielded tried, tested, and importantly reproducible results. "Clinical trials are the best and safest way" to evaluate medicines, said Francois Venter, deputy executive director of the Wits Reproductive Health and HIV Institute at the University of the Witwatersrand. The drugs are tested for safety in animals and humans, and this way of testing is widely accepted, he added. "But there are no shortcuts, they are expensive."

This standardized approach, however, is at odds with the opaque and complex belief system that underpins African traditional medicines. "We are responsible for the body, the mind, and the soul," said practicing healer Phephisile Maseko. "We are the only healing system that looks into all three, unlike Western medicine which just focuses on applying bandages."

"There is this idea that something natural is good for you, but heroin is natural," Venter said. "I'd rather take a highly synthetic compound than chew a leaf that is going to give me heart failure."

In this system, ancestral worship is intertwined with people's health, and is just as important as the plant formulations a healer dispenses. When a patient comes to Maseko, she says she asks questions about not only people's ailments, but also their histories: "'What happened to your mother? Why is there no connection between your mother and the family of your father? What happened when you were born?'"

Similarly, when Hlupheka Chabalala, head of Indigenous knowledge-based technology innovation in South Africa's Department of Science and Innovation, refers to traditional medicines, it is typically a mixture of various whole-plant extracts, rather than single, isolated compounds. The different plants in the medicine work together, he suggests: One may act as the primary medicine, while another promotes the body's absorption of the drug, or the bioavailability, and another might curb the side effects of the other plants.

The importance of family history and the benefits of complementary drug interactions are, of course, not foreign to Western medicine. The problem is that formulations and ingredients in traditional cures vary widely, making most assertions of efficacy exceedingly difficult to prove and leaving many experts dubious. "Most things are not safe if you get them from nature," said Kelly Chibale, an organic chemist who heads a drug discovery group at the University of Cape Town. "They're actually very toxic."

But testing such custom-made, non-standard preparations can prove advantageous. "If you want to push biodiversity or African traditional medicine, you have to conduct a clinical trial, a clinical study, because that's the only way scientifically you can prove something works," said Chibale. He pointed to sweet wormwood (Artemisia annua), the cousin of A. afra used in Covid Organics and an important plant in Chinese traditional medicine: "For more than 2,000 years, the Chinese have been using that drug in a concoction, as part of traditional Chinese medicine." It wasn't until the 1970s, however, that Chinese scientists derived molecules from the feathery green A. annua, called artemisinins, that now form the cornerstone of malaria therapies around the world. Artemisinin-based combination therapies have more than halved annual malaria deaths globally.

That accomplishment required modern tactics. Scientists needed to understand the chemical structure of sweet wormwood in order to identify its active pharmaceutical ingredient, Chibale explained and along the way they discovered it was poorly soluble and not absorbed well. Scientists were then able to chemically modify artemisinin to produce better-performing derivatives. In that sense, the traditional medicine served as the pathfinder for a drug that would save millions of lives but modern science was needed to bring that about. "Everything is just a starting point," Chibale said.

That notion, however, does not sit well with many traditional medicine proponents, including Chabalala, who says they should be considered an end to themselves, and not individually dissected to identify one active compound. "We use everything as nature intended it to be, even if mixing herbs," he said. "If you isolate compounds, that's when you start having problems with side effects."

Venter, a proponent of evaluating traditional medicines via clinical trials, dismisses this as unscientific. "There is this idea that something natural is good for you, but heroin is natural," he said. "I'd rather take a highly synthetic compound than chew a leaf that is going to give me heart failure."

(While A. afra does not contain artemisinin, it has also been proposed as a treatment for malaria. According to the WHO, however, chemical compounds found in the plant can vary widely and concerns about damage to the brain and heart have been reported.)

Despite the South African government's stated interest in developing drugs based on traditional cures, many people involved in traditional medicine, including Gqaleni, say South Africa's Medicines Control Council (MCC) was historically reluctant. "They thought they were lowering their standards to approve traditional medicines," Gqaleni said. But legislation to replace the MCC with the South African Health Products Regulatory Authority (Sahpra) was passed in 2015, and amid the pressures to find new ways to treat Covid-19, the agency has recently come to the table with traditional medicine advocates. Sahpra has "begun considering appropriate mechanisms of regulating proprietary African traditional medicines," spokesperson Yuven Gounden told Undark.

Historically, traditional medicines research had not been scientifically rigorous, says Salim Abdool Karim, an infectious disease epidemiologist and the chair of South Africa's Ministerial Advisory Committee on Covid-19. "So it has given traditional medicines research a bad name. But we shouldn't let a few lapses in scientific quality put us off a fundamentally important issue."

Scientists, public officials, and traditional healers all seem to agree that traditional medicines must be shown to be safe and effective. The sticking point is how this should happen. And despite a newfound willingness to engage with traditional medicines, Sahpra's evaluation unit will face practical difficulties in evaluating African traditional medicines including the lack of written records.

In China, some medical scripts date back centuries, says medical botanist Makunga. "They formalized their own traditional medicines: x amount of this plant, x amount of that plant, x amount of that plant is good for treating disease y," she said. South Africa's traditional medicine system in which dosages are based on individual handfuls and plants may be included because in a dream ancestors told a traditional healer, or an inyanga, to add them is playing catch up with these more formalized systems.

"We are responsible for the body, the mind, and the soul," explains Maseko. "We are the only health system that looks into all three, unlike Western medicine which just focuses on applying bandages."

Meanwhile, disagreement over just how traditional remedies ought to be scrutinized under Western protocols has already surfaced. In September, a regional expert committee on traditional medicine, set up by the WHO, the Africa Center for Disease Control and Prevention, and the African Union Commission for Social Affairs, endorsed protocols for traditional medicine clinical trials, although the traditional medicine regional adviser for WHO Africa, Ossy Kasilo, told Undark in an email that the protocols were currently being finalized. The guidelines, Kasilo wrote, include a "standard protocol for a multi-center, randomized, double-blind clinical trial to evaluate the safety and efficacy of herbal medicine compared to the standard of care for the treatment of hospitalized patients with mild to moderate cases" of Covid-19.

In standard clinical trials, after researchers show that their drug is safe in animals, there are four phases. The first includes a small number of healthy people to test for safety and dosage over a few months; in the second, up to several hundred people with the health condition being treated are given the drug for up to two years to gauge efficacy and side effects. The third phase involves giving the drug to between 300 and 3,000 people who have the disease, and can last for a few years, while the fourth phase continues once the drug has been made available to the public. Pharmaceutical companies have to jump through these hoops, says Venter, so other industries, such as supplements and traditional medicines, should have to as well. "The important thing is that the traditional medicine industry and it is an industry doesn't get a free ride," he said. "It has to subscribe to the same scientific methodologies."

Not everyone feels that this elaborate and painstaking system is necessary for traditional medicines. While the medicines need to be subjected to scientific rigor, they should not be treated as new chemical entities since they have been in use for centuries, argues Motlalepula Matsabisa, a pharmacologist at the University of the Free State in South Africa who chairs the WHO expert committee. The duration of phases one through three should be shorter and should include the minimum number of people, he says, and phase four should not be necessary since the therapies have already been subject to long-term use.

"People want to know: One, it will not kill me and, two, it will relieve my health problems," said Matsabisa. He later added: "There is science in African traditional medicines, and let's prove the science through the methods everyone believes in and understands."

Others go even further, suggesting no version of a modern clinical trial is appropriate. The Traditional Healers' Organization, a voluntary national nonprofit headquartered in Johannesburg, is advocating for self-regulation, rather than the imposition of an external value system. The group's perspective is that only healers should be able to evaluate traditional medicines and practices, says Maseko, who is also a spokesperson for the organization. "We can't be Western medicine," she added. "And we can't aspire to be."

Venter calls self-regulation a shocking idea. "Ask them," he said, "how they would feel if the pharmaceutical industry self-regulated."

For many experts, Covid-19 is a stark reminder that humanity is continuously confronted with new diseases. Traditional healers adapt their medicines to this changing world; their formulations and applications have changed as new diseases become more prevalent and others disappear, and they are also used in conjunction with Western drugs something that did not occur in past centuries.

Indigenous knowledge evolves too, says Makunga. As an example, she relates the story of what happened when she accompanied a healer on a walk in the Eastern Cape province. In the forest, the flowers of Bulbine plants stand out like tiny yellow stars. Traditionally, people have used the plant to treat a range of ailments from cracked lips to parasitic worms but Makunga was surprised to be told it was also good for erectile dysfunction.

"This one is really potent," Makunga recalls the healer saying. "We give it to guys and it makes you come on." Bulbine plants were particularly important for men who were "full of sugar," the healer told her, in isiXhosa, the local language. An inability to get or maintain an erection is common among men with diabetes. Diabetes prevalence has more than doubled in the last two decades, with 4.5 million people in the country suffering from the condition. "Twenty-five years ago, this was not something I was treating all the time," Makunga remembers the healer saying.

Still, there is no peer-reviewed scientific evidence that the plants are an effective treatment for erectile dysfunction in humans, nor has there been any examination of how these plants are used in traditional healing, in what dose, and in conjunction with what other plants. Indeed, the slippery nature of traditional medicine and the context in which it exists presents many challenges for anyone hoping to evaluate its safety and efficacy.

Few studies have been done, for example, on how traditional medicines interact with pharmaceuticals even though millions of South Africans likely use both on a regular basis. Makunga gives the example of pregnant women who are rushed to hospital. Sometimes they drink a traditional tonic to induce labor, but the contractions become "too intense," Makunga said. "In the hospital, the doctors didn't know what they've taken."

Despite these risks, traditional healers often have justified concerns that outsiders will steal knowledge about plants for commercial use without recognizing the community from which the knowledge originates. They can point to Hoodia gordonii , a succulent that rises out of the deserts of southern African like fat thorny fingers, as one example. For millennia, hunter-gatherers in the region in particular, the San people have chewed its watery flesh to suppress their thirst and appetites on long hunts.

South Africa's Council for Scientific and Industrial Research (CSIR), tipped off by ethnographic reports of the plant's use, began investigating the plant in 1963. By the mid-1990s, they had isolated its active pharmaceutical ingredient, P57, in the hopes of developing an appetite suppressant and, without the knowledge of the San, were granted an international patent for the ingredient. In 1998, CSIR entered into a licensing agreement with U.K.-based company Phytopharm. Following international attention and accusations of biopiracy, the CSIR entered into a benefit sharing agreement with the San people in 2003.In 2010, Phytopharm returned all development and commercialization rights to the CSIR.

Member of the San community of South Africa sample a cactus plant traditionally eaten to eliminate hunger and thirst while on long hunts. Western attempts to market the drug as a weight-loss supplement helped to sow mistrust.

Despite the furor around H. gordonii's appropriation, to date no blockbuster weight-loss drugs have emerged from it and in trials there were a number of side effects, although the plant alone is still widely used. "There is a lot of mistrust of scientists, the belief that scientists steal the information and then make a lot of money," said Vinesh Maharaj, a plant chemist at the University of Pretoria who was at the CSIR when it brokered the H. gordonii benefit-sharing agreement. Based on how little progress has been made in identifying novel drugs in traditional medicines, the idea that scientists are making money "isn't true," he said.

Still, scientists do sometimes publish traditional healers' knowledge in academic papers without consent, and the history of traditional knowledge theft looms large for many traditional practitioners. Maseko pointed by way of example to the highly-protected, proprietary formula for Coca-Cola. "That's the thing that makes it Coca Cola," she said. "If we expose our secrets to the vultures, healing is gone."

There are other reasons for secrecy. Chabalala, for example, would not reveal which herbs, aside from A. afra and cannabis, that the government is investigating to treat Covid-19. "The minute we say we're working on it, everyone will hit the forest to unsustainably start harvesting them," he said. "People will start harvesting them and preparing them not in the way healers use them. People will start researching without benefit sharing and thinking of the wisdom keepers."

On the streets of Johannesburg and on its outskirts, there are still people claiming to sell A. afra, he said. But they are not healers and there is no certainty that they are actually what they say. Patients could die, Chabalala warns. "Then people will say, 'You see'," that's what happens when you take traditional medicines.'"

Even advocates for greater scientific scrutiny of traditional remedies say that outsiders need to understand the complex system of healing of which they are only a part. Healers are not only doctors, but also counselors and spiritual guides, Makunga noted. "There is an incredible amount of power in somebody just going to a healer, before you've started to give a herbal remedy," she said.

"You would describe a feeling," she added, "and they start burning imphepho" a musky sweet Indigenous herb that is used to commune with spirits "bringing the ancestors, speaking to parts of our feelings aside from the physical."

But as both a scientist who investigates medicinal plants and as someone who understands their spiritual significance, says she knows the value of evidence. When someone tells her they use a plant to treat a specific illness, she says she wants to see the research showing that "it works 99.9 percent of the time."

The statistics are necessary, she said, "because that is my training and line of thinking."

Original post:

Bringing Traditional Healing Under the Microscope in South Africa - Medscape

Posted in Abolition Of Work | Comments Off on Bringing Traditional Healing Under the Microscope in South Africa – Medscape

The Year of COVID, Elections and Police Brutality Also Saw LGBTQ Activism – Truthout

Posted: at 10:02 am

For the past five years, Truthout has looked back at the queer and trans news you mightve missed because corporate news outlets decided not to cover it. This year, almost all of us were tangled up with the biggest news stories queer and trans people felt the effects of the COVID-19 pandemic; the feuds between the rich and powerful in Washington; the anti-racist uprisings; and the global warming-fueled hurricanes, tornadoes and wildfires.

This year has reaffirmed what many of us have known for years: Queer and trans liberation is inextricable from the liberation of all marginalized people. More than ever, we cant separate the queer and trans issues from the oppression of anyone who is marginalized. In 2020, we continue the tradition of recounting the true stories of queer and trans liberation struggles that corporate media ignored.

As protests in the summer raged against police-perpetrated executions of people like Tony McDade, a Black trans man from Tallahassee, Florida, Pride agency directors had to suck it up and say a few words about Prides anti-police roots. The director of the nonprofit that runs Los Angeles Pride announced a protest to show solidarity with the Black community against systemic racism and joining the fight for meaningful and long-lasting reform of the police. The protest was canceled when activists pointed out hypocrisies such as L.A. Prides lack of outreach to Black trans/queer people, and its letter to the Los Angeles Police Department affirming its 50 year-long strong and unified partnership with law enforcement as it planned the event.

Get reliable, independent news and commentary delivered to your inbox every day.

COVID-19 pushed most Prides onto platforms like Zoom, where it was easy for executive boards to make verbal statements in support of Black trans and queer lives; some historically pro-police Pride boards, such as San Diegos, pledged that future events would be free of uniformed officers. However, Pride boards have generally broken promises when it comes to the Black, Latinx, Indigenous, disabled and/or low-income queer and trans people who are most often targeted by the police. In the past couple of years, some of the bigger corporate Pride events in the country Columbus, Ohio, and Minneapolis, Minnesota, for example revoked public stances against the police once they decided that pro-cop, #BlueLivesMatter values were no longer a public relations liability.

President Bill Clinton proclaimed June as Pride Month back in 1999, and since then, the federal government has often dropped some concession to LGBT people (gay marriage and trans military inclusion came in June 2015 and 2017, respectively). This year, the Supreme Courts decision that LGBT people should be free from discrimination at work got a lot of applause from corporate media outlets and nonprofits, but as trans lawyer Gabriel Arkles told Truthout, Just because discrimination is illegal does not mean it wont happen Discrimination based on race, religion, national origin and disability still happens every day.

Proving discrimination is hard at least as hard as getting an employment lawyer to pay attention to your case without connections or money. With an economic depression setting in, the Biden administrations current cabinet roster should spark no false hopes that the U.S. will stop spending trillions on domestic and foreign wars, bailing out the biggest businesses, or catering to billionaire donors, while labor protections wither and people who havent hoarded money will have to get by on the charity of the richest Americans.

Realistically, none of us will know anyone who gets any concrete benefit from the Supreme Court decision, as much as it may have given liberals good feelings about the Court and reinforced beliefs that its an institution concerned about fairness. Particularly, queer people working in the underground economy, like sex workers, got nothing, and a new rule from President Trumps Labor Department gives government contractors who discriminate more reason to keep on discriminating.

Murders of trans people especially low-income, Black, Latinx and Indigenous trans women and femmes sets new records every year. This may be due to there being more attention on trans deaths and more data points to pull from, but whatever the reason, were not moving on what matters. We might be paying more attention to the problem of killings of trans people, but as many trans people point out, how many dead trans sisters names do we have to speak until more people actually care about the trans people who are breathing today?

Left out of the data: The 50 states didnt come close to the relative numbers of murders of trans women in U.S.-occupied Puerto Rico, where most weeks there are one or two preventable deaths of trans people, according to Aleksander V. Johnsen with Colectiva Solidaridad, one of the trans/queer-led organizations partnering with mutual aid programs like Brinca Charco to direct attention and protective gear to trans and nonbinary people surviving on the island right now.

The political class has mostly ignored the everyday suffering that exploded after Hurricane Marias devastation; hurricane season this year barely made news on the mainland despite the destruction and deaths it brought. Puerto Rican Gov. Ricardo Rossell resigned in 2019 after million-person-strong protests. (The major catalyst for the protests came from homophobic and misogynist texts involving jokes about cadavers from 2017s Hurricane Maria, exposing politicians enthusiasm for privatizing the islands power grid, and a deceptive, self-serving local and social media strategy.)

But people organizing against U.S. colonialism are in survival mode, working against the influence of corporate and Democratic and Republican profiteers of the shock doctrine.

People in the U.S. have less faith in the government than in any of the big corporate interests that we have reason to distrust: Pharmaceutical companies, social media platforms and corporate news conglomerates all rate as more trustworthy.

And yet there are still so many LGBTQ career politicians who want to become one with the countrys most loathed institution. After the November election, a 20-year-old foundation that exists to elect LGBTQ bureaucrats, the LGBTQ Victory Fund, gifted journalists with a press release in which the organization congratulates itself on helping elect more out candidates than in any other U.S. election. The fund and its associated politician training camp, the Victory Institute, claim to be nonpartisan and without any political agenda, in the same vein of celebrities participating in get-out-the-vote campaigns who dont want to alienate fans and patrons: It doesnt matter who you vote for as long as you vote!

Every election sucks up more resources than the last, and the Center for Responsive Politics reports most members of the House are millionaires. Obviously, most queer and non-queer people are not rich. Victory and other gay nonprofits that pivoted to electing gay politicians after gay people could legally get married and join the military attempt to avoid the intersectionality issue especially around poverty.

The foundations social media recently celebrated the elections of TWO new lesbian sheriffs!! [sic], and in one of the few races between two openly LGBTQ candidates, it endorsed a gay, white, status-quo lawyer funded by real estate over an Indigenous and Latinx queer socialist. The fund partners on campaigns with GOPAC (essentially a mirror of the Victory Fund brought to us by right-wing politicians like Newt Gingrich and Michael Steele), which exclusively supports conservative candidates.

The Victory Fund also endorsed Pete Buttigieg, who will become the first gay person to lead the U.S. Department of Transportation in January. The gay magazine Out (by no means a leftist news source) surveyed its readers on Democratic primary candidates. Mayor Pete came in as their fourth choice. Major fundraisers for Buttigieg in Chicago and other cities were interrupted by queer and trans activists who acted independently, though a few came to form loose organizations. The group Queers Against Pete put out a statement listing Buttigiegs opposition to reinstating free tuition at public universities (and canceling student debt) and his anti-universal health care/Medicare for All stance as a couple of his many positions that uphold systems that antagonize non-rich queer people. While mayor of South Bend, Indiana, he helped developers gentrify and demolish low-income neighborhoods, and refused to release tapes related to the murder of Eric Logan, a Black person killed by cops. Another multi-city effort, Queers Not Here for Mayor Pete, collected some of the writing by queers against the politician.

Like Gay Pride, the tech industry conference named Lesbians Who Tech and Allies moved online in 2020. This years program featured public relations emissaries from corporations innovating new forms of surveillance, drone bombs and ending labor protections. Multiple Black Lives Matter panels and celebrity appearances by Kamala Harris, Nancy Pelosi, soccer player Megan Rapinoe and Melinda Gates distracted from the ugliness of the industry that spends more on lobbying than any other sector. BlackRock, Goldman Sachs, Nextdoor.com and the CIA were among the sponsors behind the yearly event, which gives corporate public relations emissaries the chance to paint their overlords as socially progressive, giving panels like Life at Amazon: Inclusive Hiring Process and The Integration of Technology and Finance.

In 2016, the Obama administration officially dubbed the Stonewall Inn the first LGBT national monument, but gentrification threatened that bar, the site of an infamous 1969 anti-police riot, and its owners say theyre relying on GoFundMe to keep the place open.

In 2018 and 2019, San Francisco officially designated neighborhoods of the city as the Transgender District, the Leather District (leather as in the fetish) and the LGBTQ District. Funded mostly through taxes, the city created small bureaucracies around the districts, with tax money going to staff and, for example, the symbolic metal plaques that describe leather culture, or the painting and maintenance of lampposts in the Transgender District now decorated with the baby blue, baby pink and white of the original trans flag.

Most of the areas leather bars never reopened after Marchs statewide shutdown, including the citys longest continuously operating queer bar, the collectively-owned Stud, and the Eagle bar, whose owners worked with developers on a plan to construct hundreds of luxury apartments adjacent to where the Eagle was, which rent for up to $5,800 per month. The community got some plaques and a flag pole, intended to fly a giant flag representing leather culture. But now it is just a flagless pole.

Housing aid for trans people exists in many major U.S. cities, but most of these programs are temporary, like rent vouchers. Money for these programs could be cut with a politicians pen, and ultimately just ends up in the bank accounts of landlords and/or real estate investment trusts that operate as mega-landlords, owning tens and sometimes hundreds of thousands of apartments and flats across the country.

Homelessness has always affected queer and trans people more than most. Some queer and trans groups worked on preventing an exacerbation of the homelessness crisis that has already begun, despite a federal moratorium on evictions through January 31, 2021. GLITS (short for Gays and Lesbians In a Transgender Society) is a trans sex worker-led organization that bought a 12-unit building to house low-income trans people in New York. House of Tulip is working on a similar project in New Orleans. In Minneapolis, Share-a-ton was the brief but inspiring squat housing 200 homeless people who worked with volunteers to turn a vacant hotel into shelter that the local governments austerity policies wouldnt provide. And the anarchist organizers of Seattles anti-cop Capitol Hill Autonomous Zone (CHAZ) organized and camped out to end police violence against people of color, including all people of marginalized, intersectional identities. However, police broke the citys own ban on chemical weapons by dispersing the zone in clouds of teargas.

Mutual aid between queers happens every time a queer person sleeps on another persons couch, or helps to cook meals for Food Not Bombs deliveries, or cleans a community fridge at the end of the day. When officials and institutions with power dont help people during rough times, people come up with ways to get what they need.

Artist and activist Tourmaline beautifully describes the power of mutual aid in a piece on freedom dreaming: Freedom dreams are born when we face harsh conditions not with despair, but with the deep knowledge that these conditions will change that a world filled with softness and beauty and care is not only possible, but inevitable.

Following the Freedom Schools of civil rights battles in the South in the 1960s, Tourmaline writes that freedom dreaming isnt just about the big things the huge world changes that we are manifesting in our movements, like police and prison abolition, free universal healthcare, and gender self-determination for all. Its about those things, but also small acts:

When I take a walk down my block, and slow down to touch and smell the blooming flowers, bursting with vitality, Im freedom dreaming. I am allowing myself to live in a world where nature is a teacher and friend.

When I Venmo my friend $25 with a heart emoji, so that they can safely take a cab home from a protest or a date or a doctors appointment, Im freedom dreaming. I am creating a world in which we can all move around safely, without fear of harassment.

When I stay in bed all day, luxuriating in rest, moving in and out of cat naps, Im freedom dreaming. I am living in the knowledge that I dont have to be productive in the ways capitalism demands of us in order to deserve relaxation and recuperation.

Truthout contributor Dean Spade wrote a fantastic, read-it-in-a-day primer on mutual aid that lays out, for those of us lacking inspiration or imagination, how people in community with each other have always performed mutual aid and how it can help us live through crises and their aftershocks.

Disabled people make up the majority of people locked up and terrorized by law enforcement, and calling 911 is a terrible option for people who cops are more likely to harm than help. The case for prison abolition rather than the reform of a rotten system is even clearer thanks to events like the Portland Disability Justice Collectives November conference that connected mutual aid, race and poverty. Meanwhile, two books out this year from Truthout staff and contributors describe how reforms to the criminal legal system usually cause more terror for marginalized queers, and/or low-income, disabled people and substance users: Prison By Any Other Name and The Feminist and the Sex Offender.

The Oakland and Sacramento chapters of the Anti-Police Terror Project (APTP) created alternatives to calling 911 during a psychiatric emergency. This tool launched in several cities, formed mostly by queer and trans people. A call, a text or a direct message on social media goes to volunteers who respond to people experiencing mental health crises to APTPs Mental Health First project.

Meanwhile, Visual AIDS launched Strip AIDS, a comic series about the ongoing plague that covers issues like HIV criminalization, and how detention centers, jails and prisons are the worst place to be during a pandemic, with miserable outcomes for people inside and out of the system.

The San Francisco direct action collective Gay Shame created Abolition is the Floor Not the Ceiling, a project imagining a world where reparations for Black people is more than just a check. Gay Shame followed this with anti-gentrification actions like a Halloween night street takeover called Night of the Living Next Door, which tied surveillance partnerships between Big Tech and government agencies to increased deaths and jailing of homeless people, and housing unaffordability for trans/queer tenants who face the threat of eviction as landlords get richer.

Some of these projects might not exist this time next year, but as long as police-perpetrated violence and inequality continue, radical trans and queer people will keep freedom dreaming.

Go here to see the original:

The Year of COVID, Elections and Police Brutality Also Saw LGBTQ Activism - Truthout

Posted in Abolition Of Work | Comments Off on The Year of COVID, Elections and Police Brutality Also Saw LGBTQ Activism – Truthout