StemCell Therapy

We are often asked to not skip meals; ever wondered why? It has been said that skipping meals can alter our blood sugar levels and make us put on weight as opposed to doing the opposite.

So, if you are an otherwise-healthy person who is looking to lose weight, do not fall for fads that suggest you avoid eating food. Why is it so?

Explaining the connection between weight, blood sugar, and meals, nutritionist Nmami Agarwal explained in an Instagram post that eating irregular meals can affect our health. The body gets surprised by too much food or no food at all, she said in a video, adding that when we skip meals, our blood sugar levels drop, which makes us overeat during our next meal.

This further makes our blood sugar levels rise quickly. There is a fluctuation highs and lows in your blood sugar levels [which can] put the body at risk of getting diabetes. And when you skip your meals and you overeat at the next meal, the excess calorie is converted into fat and stored, she warned.

According to Agarwal, this can make you gain weight. Now, the ideal thing that you can do for your body is to not skip meals and eat at a regular interval, she said.

Concurring with her, nutritionist and chef Ishti Saluja told indianexpress.com that when people focus on weight loss, they often skip meals. Yes, a calorie deficit does lead to weight loss, but it also leads to nutritional deficiencies, muscle loss and worst of all, hormonal imbalance, she said, adding that the body perceives the lack of food as a sign of stress and so, it releases stored energy to go on with the day.

But, that energy does not match up to the physical activity that is required to use that released energy, so it gets stored back as fat along with the added food that has been consumed throughout the day. This back and forth of energy going up and down due to stress and skipping meals leads to insulin resistance, among other hormonal imbalances. It causes stubborn weight around the abdomen and lower abdomen area, energy fluctuation and mood swings, she explained.

Saluja said cortisol a stress hormone dysregulation is another common side effect. Ideally, it should be at its highest level when you wake up in the morning, and should gradually go down by the time you hit the bed. But, when a person has imbalanced cortisol levels, these timings go haywire and it leads to people waking up groggy; they have a burst of energy in the evenings, making them struggle to fall asleep.

Dr Varsha Gorey, senior clinical dietitian, HOD, dietetics department at Apollo Hospitals Navi Mumbai summarised this by stating that when we starve or fast, we feel low on energy. Having a long gap [between meals] can cause an energy deficit, fatigue and dehydration. When we skip a meal and then eat, we tend to either eat too much, or the wrong kind of food, or the carbohydrate content is very high, which can lead to a sudden rise in the blood glucose level. This can make us feel lethargic. Occasionally, it is fine, but if it becomes a habit, it will impact your weight.

The importance of healthy nutrition

Dr Gorey told this outlet that we should have small and frequent meals at least four meals which are breakfast, lunch and dinner, and two mid-morning and mid-evening snacks (like fruits and nuts). Whenever you have a meal, focus on the proteins first, followed by fibre, and then carbohydrates. If we follow this pattern, it can help us control our blood sugar, weight and prevent and manage diabetes, she concluded.

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Can skipping a meal lead to diabetes and fat around abdomen? - The Indian Express

ReportLinker

The Global Type 2 Diabetes Drugs Market size was estimated at USD 60. 82 billion in 2021 and expected to reach USD 65. 75 billion in 2022, and is projected to grow at a CAGR 8. 38% to reach USD 98.

New York, Oct. 14, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Type 2 Diabetes Drugs Market Research Report by Drug, Application, Distribution, Region - Global Forecast to 2027 - Cumulative Impact of COVID-19" - https://www.reportlinker.com/p06342114/?utm_source=GNW 62 billion by 2027.

Market Statistics:The report provides market sizing and forecast across 7 major currencies - USD, EUR, JPY, GBP, AUD, CAD, and CHF. It helps organization leaders make better decisions when currency exchange data is readily available. In this report, the years 2018 and 2020 are considered as historical years, 2021 as the base year, 2022 as the estimated year, and years from 2023 to 2027 are considered as the forecast period.

Market Segmentation & Coverage:This research report categorizes the Type 2 Diabetes Drugs to forecast the revenues and analyze the trends in each of the following sub-markets:

Based on Drug, the market was studied across Injectables and Oral. The Injectables is further studied across Aspart, Exenatide, Glargine, Insulin, Leraglutide, and Pramlintide. The Oral is further studied across Alpha-Glucosidase Inhibitors, Biguanides, Dipeptidyl Peptidase-4 Inhibitors, Glucagon-Like Peptide, Receptor Agonists, Secretagogues, Sodium Glucose Cotransport 2 Inhibitors, Sulfonylureas, and Thiazolidinediones.

Based on Application, the market was studied across Cardiovascular Safety, Glycemic Control, and Hypoglycemia Avoidance.

Based on Distribution, the market was studied across Hospital Pharmacies, Online Pharmacies, and Retail Pharmacies.

Based on Region, the market was studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Cumulative Impact of COVID-19:COVID-19 is an incomparable global public health emergency that has affected almost every industry, and the long-term effects are projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlying COVID-19 issues and potential paths forward. The report delivers insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecasts, considering the COVID-19 impact on the market.

Cumulative Impact of 2022 Russia Ukraine Conflict:We continuously monitor and update reports on political and economic uncertainty due to the Russian invasion of Ukraine. Negative impacts are significantly foreseen globally, especially across Eastern Europe, European Union, Eastern & Central Asia, and the United States. This contention has severely affected lives and livelihoods and represents far-reaching disruptions in trade dynamics. The potential effects of ongoing war and uncertainty in Eastern Europe are expected to have an adverse impact on the world economy, with especially long-term harsh effects on Russia.This report uncovers the impact of demand & supply, pricing variants, strategic uptake of vendors, and recommendations for Type 2 Diabetes Drugs market considering the current update on the conflict and its global response.

Competitive Strategic Window:The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.

FPNV Positioning Matrix:The FPNV Positioning Matrix evaluates and categorizes the vendors in the Type 2 Diabetes Drugs Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Market Share Analysis:The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.

Competitive Scenario:The Competitive Scenario provides an outlook analysis of the various business growth strategies adopted by the vendors. The news covered in this section deliver valuable thoughts at the different stage while keeping up-to-date with the business and engage stakeholders in the economic debate. The competitive scenario represents press releases or news of the companies categorized into Merger & Acquisition, Agreement, Collaboration, & Partnership, New Product Launch & Enhancement, Investment & Funding, and Award, Recognition, & Expansion. All the news collected help vendor to understand the gaps in the marketplace and competitors strength and weakness thereby, providing insights to enhance product and service.

Company Usability Profiles:The report profoundly explores the recent significant developments by the leading vendors and innovation profiles in the Global Type 2 Diabetes Drugs Market, including Abbott Laboratories, Amgen Inc., AstraZeneca Plc., Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Chugai Pharmaceutical Co., Daiichi Sankyo Co. Ltd, Eli Lilly and Co., GlaxoSmithKline Plc., Johnson & Johnson Services, Inc., Merck & Co., Inc., Novartis AG, Novo Nordisk AS, Peptron, Pfizer Inc., Sanofi Aventis A/S, Sanofi SA, Sun Pharmaceutical Industries Limited, and Takeda Pharmaceutical Co. Ltd.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on the market offered by the key players2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments

The report answers questions such as:1. What is the market size and forecast of the Global Type 2 Diabetes Drugs Market?2. What are the inhibiting factors and impact of COVID-19 shaping the Global Type 2 Diabetes Drugs Market during the forecast period?3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Type 2 Diabetes Drugs Market?4. What is the competitive strategic window for opportunities in the Global Type 2 Diabetes Drugs Market?5. What are the technology trends and regulatory frameworks in the Global Type 2 Diabetes Drugs Market?6. What is the market share of the leading vendors in the Global Type 2 Diabetes Drugs Market?7. What modes and strategic moves are considered suitable for entering the Global Type 2 Diabetes Drugs Market?Read the full report: https://www.reportlinker.com/p06342114/?utm_source=GNW

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Type 2 Diabetes Drugs Market Research Report by Drug, Application, Distribution, Region - Global Forecast to 2027 - Cumulative Impact of COVID-19 -...

This report segments the neuropathy pain treatment market by indication (diabetic neuropathy, chemotherapy-induced neuropathy pain, postherpetic neuralgia, and others) and geography (North America, Europe, APAC, South America, and Middle East and Africa)

NEW YORK, Oct. 4, 2022 /PRNewswire/ -- One of the key trends in the neuropathy pain treatment market growth is the growing focus on emerging economies. Research institutes and vendors are focusing on tapping potential treatments in emerging economies, which will bring substantial growth opportunities. The increasing number of individuals requiring pain treatment has increased the demand for neuropathy pain treatment in countries such as China, India, and Brazil. Research institutes have also issued guidelines to address unmet needs in the treatment of pain. For instance, in APAC, a group of pain specialists has created tailored guidelines for each region. In addition, vendors are establishing new units in emerging economies such as Brazil to expand their presence in the market. Such initiatives will drive market growth during the forecast period.

Technavio has announced its latest market research report titled Global Neuropathy Pain Treatment Market 2022-2026

The global neuropathy pain treatment market size is expected to grow by USD 3.81 billion between 2021 to 2026. In addition, the growth momentum of the market will accelerate at a CAGR of 9.18%, according to Technavio's latest market report.

Get a comprehensive report summary that describes the market size and forecast along with research methodology. The FREE sample reportis available in PDF format

Neuropathy Pain Treatment Market: Market Segmentation

By indication, the diabetic neuropathy segment will be the largest contributor to market growth during the forecast period. Most of the currently approved therapies provide only symptomatic relief. Hence, there is a need for disease-modifying treatments that might slow, prevent, or reverse the progression of nerve damage. Vendors are extensively focusing on R&D activities to address this unmet medical need. For instance, in January 2019, Daiichi Sankyo Company received marketing approval in Japan for the Tarlige drug for the treatment of peripheral neuropathic pain.

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In terms of geography, North America will present significant opportunities for market vendors due to the factors such as the growing prevalence of diabetes. The region will account for 33% of the market's growth during the forecast period. Moreover, market growth in this region will be faster than the growth of the market in other regions. The US and Canada are the key countries for the neuropathy pain treatment market in North America.

Neuropathy Pain Treatment Market: Major Growth Drivers

The focus on the development of novel therapeutics for postherpetic neuralgia is driving the neuropathy pain treatment market growth. Postherpetic neuralgia is a complication of shingles caused by the chickenpox virus. There are various drugs for the treatment of postherpetic neuralgia. However, the lack of effective therapeutics has negatively impacted the adoption rates. Therefore, vendors are focusing on the development of potential alternatives. Currently, there are around nine molecules for the treatment of postherpetic neuralgia in different stages of development. Such developments will fuel the growth of the global neuropathy pain treatment market growth during the forecast period.

Technavio has identified key trends, drivers, and challenges in the market, which will help vendors improve their strategies to stay ahead of their competitors. View our FREE PDF Sample Report

Neuropathy Pain Treatment Market: Key Vendors

Abbott Laboratories, Assertio Therapeutics Inc., Astellas Pharma Inc., AstraZeneca Plc, Aurobindo Pharma Ltd., Baxter International Inc., Biogen Inc., Bristol Myers Squibb Co., Dr. Reddys Laboratories Ltd, Eli Lilly, and Co., Endo International Plc, GlaxoSmithKline Plc, Johnson and Johnson, Mallinckrodt Plc, Novartis AG, Pfizer Inc., Sanofi SA, Sun Pharmaceutical Industries Ltd, VistaGen Therapeutics Inc., among others, are the main players in the market.

Neuropathy Pain Treatment Market: Reasons to Buy Our Report

CAGR of the market during 2022-2026

Detailed information on factors that will help the neuropathy pain treatment market grow during the next five years

Approximation of the neuropathy pain treatment market size and its contribution to the parent market

Forecasts on upcoming trends and changes in consumer behavior

The growth of the neuropathy pain treatment market across North America, Europe, APAC, South America, and Middle East and Africa

Analysis of the market's competitive landscape and detailed information on vendors

Comprehensive details of factors that will challenge the growth of neuropathy pain treatment market vendors

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Neuropathy Pain Treatment Market Scope

Report Coverage

Details

Page number

120

Base year

2021

Forecast period

2022-2026

Growth momentum & CAGR

Accelerate at a CAGR of 9.18%

Market growth 2022-2026

USD 3.81 billion

Market structure

Fragmented

YoY growth (%)

11.03

Regional analysis

North America, Europe, APAC, South America, and Middle East and Africa

Performing market contribution

North America at 33%

Key consumer countries

US, Canada, India, Germany, and UK

Competitive landscape

Leading companies, competitive strategies, consumer engagement scope

Companies profiled

Abbott Laboratories, Assertio Therapeutics Inc., Astellas Pharma Inc., AstraZeneca Plc, Aurobindo Pharma Ltd., Baxter International Inc., Biogen Inc., Bristol Myers Squibb Co., Dr Reddys Laboratories Ltd, Eli Lilly and Co., Endo International Plc, GlaxoSmithKline Plc, Johnson and Johnson, Mallinckrodt Plc, Novartis AG, Pfizer Inc., Sanofi SA, Sun Pharmaceutical Industries Ltd, and VistaGen Therapeutics Inc.

Market Dynamics

Parent market analysis, market growth inducers and obstacles, fast-growing and slow-growing segment analysis, COVID-19 impact and future consumer dynamics, and market condition analysis for the forecast period.

Customization purview

If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

Browse Health CareMarket Reports

Table of Contents

1 Executive Summary

2 Market Landscape

3 Market Sizing

4 Five Forces Analysis

5 Market Segmentation by Indication

6 Customer Landscape

7 Geographic Landscape

8 Drivers, Challenges, and Trends

9 Vendor Landscape

10 Vendor Analysis

11 Appendix

About Us

Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

ContactTechnavio ResearchJesse MaidaMedia & Marketing ExecutiveUS: +1 844 364 1100UK: +44 203 893 3200Email: media@technavio.comWebsite: http://www.technavio.com/

Global Neuropathy Pain Treatment Market 2022-2026

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SOURCE Technavio

See original here:
Neuropathy Pain Treatment Market Size to Grow by USD 3.81 Bn, Growing Focus on Emerging Economies to be a Key Trend - Technavio - Yahoo Finance

NEW YORK, Oct. 5, 2022 /PRNewswire/ -- The Global Pregabalin Market by Application and Geography Forecast and Analysis 2022-2026 size is expected to grow by USD 153.03 million from 2022 to 2026, at a CAGR of 3.74%. The increasing presence of a large patient pool related to neuropathic pain, the increasing geriatric population, and the rising applications of pregabalin in various diseases are themajor factors propelling the market growth. However, the growing preference for alternatives and stringent regulatory policies may impede market growth. To get more insights on drivers and challenges Request a Sample PDF

Technavio has announced its latest market research report titled Global Pregabalin Market 2022-2026

Key Market Dynamics:

Market Driver: The presence of a large patient pool related to neuropathic pain is one of the key drivers supporting thepregabalin market growth.Neuropathic pain is associated with various disorders such as diabetic neuropathy, chemotherapy-induced pain, shingles, and herniated disk. There have been growing cases of these disorders, especially in the geriatric population. Meanwhile, the increasing number of individuals preferring chemotherapy for cancer treatment is fueling cases of chemotherapy-induced pain. Furthermore, according to the CDC, the incidence of shingles is approximately four per 1,000 US population annually. Overall, there are an estimated one million cases of herpes zoster in the US annually. Such a scenario will lead to an increase in the adoption of pregabalin, which, in turn, will drive the growth of the market during the forecast period.

Market Challenges: Growing preference for alternatives is one of the key factors hindering thepregabalin market growth.As the current treatments are associated with many unmet needs, end-users are looking to shift to alternative therapies. For instance, diabetic neuropathic pain can be reduced by supplementing essential acids, alpha-lipoic acid, gamma-linolenic acid, and omega-3 fatty acids. Similarly, acupuncture can be an effective way to manage peripheral neuropathy. Acupuncture uses pressure points across the body to realign the body's energy.Thus, the use of these alternative therapies may hinder growth prospects in the forecast period.

To get insights about additional key drivers, trends, and challenges available with Technavio.Read our Sample Report right now!

Market Segmentation

North Americawill be the leading region with 36% of the market's growth during the forecast period. The US and Canada are the key countries for the pregabalin market inNorth America. The increase in the older population, coupled with the established adoption of LYRICA and Cymbalta in new indications and the introduction of new drugs for the treatment of neuropathic pain, will facilitate thepregabalin market growth in North America over the forecast period.

The Neuropathic pain application segment will contribute the highest market share growth during the forecast period. Neuropathic pain affects 20% to 30% of diabetic neuropathy patients. Thus, the demand for pregabalin is rising due to more occurrences of diabetic neuropathy, which is boosting the growth of the market.Pregabalin is an alternative treatment for people with neuropathic pain that has not responded to other drugs.It effectively reduces the symptoms of numerous neuropathic pain conditions and positions itself as a first-line therapy option with exceptional safety and efficacy.These factors will drive segment growth during the forecast period.

View our sample reportfor additional insights into the contribution of all the segments, and regional opportunities in the report.

Some Companies Mentioned with their Offerings

Related Reports:

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Pregabalin Market Scope

Report Coverage

Details

Page number

120

Base year

2021

Forecast period

2022-2026

Growth momentum & CAGR

Accelerate at a CAGR of 3.74%

Market growth 2022-2026

USD 153.03 million

Market structure

Fragmented

YoY growth (%)

3.27

Regional analysis

North America, Europe, Asia, and Rest of World (ROW)

Performing market contribution

North America at 36%

Key consumer countries

US, Canada, Germany, China, Japan, and Republic of Korea

Competitive landscape

Leading companies, competitive strategies, consumer engagement scope

Companies profiled

Biomax Biotechnics Pvt.Ltd., Camber Pharmaceuticals Inc., Cipla Ltd., Dr. Kumars Pharmaceuticals, Genesis Biotec Inc., H. L. Healthcare Pvt. Ltd., Lupin Ltd, Medley Pharmaceuticals Ltd., MK Medicine, MSN Laboratories, Neuracle Lifesciences Pvt. Ltd., Novartis AG, Pfizer Inc., Phoenix Biologicals Pvt. Ltd., Sun Pharmaceutical Industries Ltd, Swastik Life Sciences, Torrent Pharmaceuticals Ltd., and Vibcare Pharma Pvt. Ltd.

Market Dynamics

Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and future consumer dynamics, and market condition analysis for the forecast period.

Customization purview

If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

Table of Contents:

1 Executive Summary

2 Market Landscape

3 Market Sizing

4 Five Forces Analysis

5 Market Segmentation by Application

6 Customer Landscape

7 Geographic Landscape

8 Drivers, Challenges, and Trends

9 Vendor Landscape

10 Vendor Analysis

11 Appendix

About Us

Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.

With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

ContactTechnavio ResearchJesse MaidaMedia & Marketing ExecutiveUS: +1 844 364 1100UK: +44 203 893 3200Email:media@technavio.comWebsite:www.technavio.com/

Global Pregabalin Market 2022-2026

Cision

View original content to download multimedia:https://www.prnewswire.com/news-releases/pregabalin-market-to-grow-by-usd-153-03-mn-from-2022-to-2026--driven-by-presence-of-large-patient-pool-related-to-neuropathic-pain---technavio-301640610.html

SOURCE Technavio

Read more:
Pregabalin Market to Grow by USD 153.03 Mn from 2022 to 2026, Driven by Presence of Large Patient Pool Related To Neuropathic Pain - Technavio - Yahoo...

Feldman, E. L., Nave, K., Jensen, T. S. & Bennett, D. L. H. New horizons in diabetic neuropathy: Mechanisms, bioenergetics, and pain. Neuron 93, 12961313 (2017).

CAS PubMed PubMed Central Google Scholar

Callaghan, B. C., Cheng, H. T., Stables, C. L., Smith, A. L. & Feldman, E. L. Diabetic neuropathy: Clinical manifestations and current treatments. Lancet Neurol. 11, 521534 (2012).

PubMed PubMed Central Google Scholar

Jensen, T. S. & Finnerup, N. B. Allodynia and hyperalgesia in neuropathic pain: Clinical manifestations and mechanisms. Lancet Neurol. 13, 924935 (2014).

PubMed Google Scholar

Truini, A., Garcia-Larrea, L. & Cruccu, G. Reappraising neuropathic pain in humansHow symptoms help disclose mechanisms. Nat. Rev. Neurol. 9, 572582 (2013).

CAS PubMed Google Scholar

Gandhi, R. A. & Selvarajah, D. Understanding and treating painful diabetic neuropathy: Time for a paradigm shift. Diabet. Med. 32, 771777 (2015).

CAS PubMed Google Scholar

Harris, K., Boland, C., Meade, L. & Battise, D. Adjunctive therapy for glucose control in patients with type 1 diabetes. Diabetes Metab. Syndr. Obes. 11, 159173 (2018).

CAS PubMed PubMed Central Google Scholar

Yagihashi, S., Mizukami, H. & Sugimoto, K. Mechanism of diabetic neuropathy: Where are we now and where to go?. J. Diabetes Investig. 2, 1832 (2011).

CAS PubMed Google Scholar

Lee, A. Y. & Chung, S. S. Contributions of polyol pathway to oxidative stress in diabetic cataract. FASEB J. 13, 2330 (1999).

CAS PubMed Google Scholar

Brownlee, M. Biochemistry and molecular cell biology of diabetic complications. Nature 414, 813820 (2001).

ADS CAS PubMed Google Scholar

Yan, L.-J. Pathogenesis of chronic hyperglycemia: From reductive stress to oxidative stress. J. Diabetes Res. 2014, 137919 (2014).

PubMed PubMed Central Google Scholar

Schreiber, A. K., Nones, C. F. M., Reis, R. C., Chichorro, J. G. & Cunha, J. M. Diabetic neuropathic pain: Physiopathology and treatment. World J. Diabetes. 6, 432444 (2015).

PubMed PubMed Central Google Scholar

Thornalley, P. J. Glycation in diabetic neuropathy: Characteristics, consequences, causes, and therapeutic options. Int. Rev. Neurobiol. 50, 3757 (2002).

CAS PubMed Google Scholar

Juranek, J., Ray, R., Banach, M. & Rai, V. Receptor for advanced glycation end-products in neurodegenerative diseases a bad reputation. Rev. Neurosci. 26, 691698 (2015).

PubMed Google Scholar

Greene, D. A., Stevens, M. J., Obrosova, I. & Feldman, E. L. Glucose-induced oxidative stress and programmed cell death in diabetic neuropathy. Eur. J. Pharmacol. 375, 217223 (1999).

CAS PubMed Google Scholar

Pop-Busui, R., Sima, A. & Stevens, M. Diabetic neuropathy and oxidative stress. Diabetes Metab. Res. Rev. 22, 257273 (2006).

CAS PubMed Google Scholar

Ishii, D. N. & Lupien, S. B. Insulin-like growth factors protect against diabetic neuropathy: Effects on sensory nerve regeneration in rats. J. Neurosci. Res. 40, 138144 (1995).

CAS PubMed Google Scholar

Fernyhough, P. & Calcutt, N. A. Abnormal calcium homeostasis in peripheral neuropathies. Cell Calcium 47, 130139 (2010).

CAS PubMed Google Scholar

Koya, D. et al. Characterization of protein kinase C beta isoform activation on the gene expression of transforming growth factor-beta, extracellular matrix components, and prostanoids in the glomeruli of diabetic rats. J. Clin. Investig. 100, 115126 (1997).

CAS PubMed PubMed Central Google Scholar

Akude, E. et al. Diminished superoxide generation is associated with respiratory chain dysfunction and changes in the mitochondrial proteome of sensory neurons from diabetic rats. Diabetes 60, 288297 (2011).

CAS PubMed Google Scholar

Chowdhury, S. K. R. et al. Mitochondrial respiratory chain dysfunction in dorsal root ganglia of streptozotocin-induced diabetic rats and its correction by insulin treatment. Diabetes 59, 10821091 (2010).

CAS PubMed PubMed Central Google Scholar

Younger, D. S., Rosoklija, G., Hays, A. P., Trojaborg, W. & Latov, N. Diabetic peripheral neuropathy: A clinicopathologic and immunohistochemical analysis of sural nerve biopsies. Muscle Nerve. 19, 722727 (1996).

CAS PubMed Google Scholar

Tomlinson, D. R. & Gardiner, N. J. Diabetic neuropathies: Components of etiology. J. Peripher. Nerv. Syst. 13, 112121 (2008).

CAS PubMed Google Scholar

Satoh, J., Yagihashi, S. & Toyota, T. The possible role of tumor necrosis factor- in diabetic polyneuropathy. Exp. Diabesity Res. 4, 6571 (2003).

PubMed PubMed Central Google Scholar

Yamagishi, S.-I. et al. Correction of protein kinase C activity and macrophage migration in peripheral nerve by pioglitazone, peroxisome proliferator activated-gamma-ligand, in insulin-deficient diabetic rats. J. Neurochem. 104, 491499 (2008).

CAS PubMed Google Scholar

Du, Y. et al. Effects of p38 MAPK inhibition on early stages of diabetic retinopathy and sensory nerve function. Investig. Ophthalmol. Vis. Sci. 51, 21582164 (2010).

Google Scholar

Seger, R. & Krebs, E. G. The MAPK signaling cascade. FASEB J. 9, 726735 (1995).

CAS PubMed Google Scholar

Lewis, T. S., Shapiro, P. S. & Ahn, N. G. Signal transduction through MAP kinase cascades. Adv. Cancer Res. 74, 49139 (1993).

Google Scholar

Widmann, C., Gibson, S., Jarpe, M. B. & Johnson, G. L. Mitogen-activated protein kinase: Conservation of a three-kinase module from yeast to human. Physiol. Rev. 79, 143180 (1999).

CAS PubMed Google Scholar

Obata, K. & Noguchi, K. MAPK activation in nociceptive neurons and pain hypersensitivity. Life Sci. 74, 26432653 (2004).

CAS PubMed Google Scholar

Johnson, G. L. & Lapadat, R. Mitogen-activated protein kinase pathways mediated by ERK, JNK, and p38 protein kinases. Science 298, 19111912 (2002).

ADS CAS PubMed Google Scholar

Krishna, M. & Narang, H. The complexity of mitogen-activated protein kinases (MAPKs) made simple. Cell Mol. Life Sci. 65, 35253544 (2008).

CAS PubMed Google Scholar

Yang, S.-H., Sharrocks, A. D. & Whitmarsh, A. J. Transcriptional regulation by the MAP kinase signaling cascades. Gene 320, 321 (2003).

CAS PubMed Google Scholar

Bonny, C., Borsello, T. & Zine, A. Targeting the JNK pathway as a therapeutic protective strategy for nervous system diseases. Rev. Neurosci. 67, 5767 (2005).

Google Scholar

Tsuda, M., Ueno, H., Kataoka, A., Tozaki-Saitoh, H. & Inoue, K. Activation of dorsal horn microglia contributes to diabetes-induced tactile allodynia via extracellular signal-regulated protein kinase signaling. Glia 56, 378386 (2008).

PubMed Google Scholar

Wodarski, R., Clark, A. K., Grist, J., Marchand, F. & Malcangio, M. Gabapentin reverses microglial activation in the spinal cord of streptozotocin-induced diabetic rats. Eur. J. Pain 13, 807811 (2009).

CAS PubMed Google Scholar

Manning, A. M. & Davis, R. J. Targeting JNK for therapeutic benefit: From junk to gold?. Nat. Rev. Drug Discov. 2, 554565 (2003).

CAS PubMed Google Scholar

Agell, N., Bachs, O., Rocamora, N. & Villalonga, P. Modulation of the Ras/Raf/MEK/ERK pathway by Ca(2+), and calmodulin. Cell Signal. 4, 649654 (2002).

Google Scholar

White, C. D. & Sacks, D. B. Regulation of MAP kinase signaling by calcium. Methods Mol. Biol. 661, 151165 (2010).

CAS PubMed Google Scholar

Rosen, L. B., Ginty, D. D., Weber, M. J. & Greenberg, M. E. Membrane depolarization and calcium influx stimulate MEK and MAP kinase via activation of Ras. Neuron 12, 12071221 (1994).

CAS PubMed Google Scholar

Purves, T. et al. A role for mitogen-activated protein kinases in the etiology of diabetic neuropathy. FASEB J. 15, 25082514 (2001).

CAS PubMed Google Scholar

Price, S. A., Agthong, S., Middlemas, A. B. & Tomlinson, D. R. Mitogen-activated protein kinase p38 mediates reduced nerve conduction velocity in experimental diabetic neuropathy: Interactions with aldose reductase. Diabetes 53, 18511856 (2004).

CAS PubMed Google Scholar

Tsuda, M., Mizokoshi, A., Shigemoto-Mogami, Y., Koizumi, S. & Inoue, K. Activation of p38 mitogen-activated protein kinase in spinal hyperactive microglia contributes to pain hypersensitivity following peripheral nerve injury. Glia 45, 8995 (2004).

PubMed Google Scholar

Daulhac, L. et al. Diabetes-induced mechanical hyperalgesia involves spinal mitogen-activated protein kinase activation in neurons and microglia via N-methyl-d-aspartate-dependent mechanisms. Mol. Pharmacol. 70, 12461254 (2006).

CAS PubMed Google Scholar

Piao, Z. G. et al. Activation of glia and microglial p38 MAPK in medullary dorsal horn contributes to tactile hypersensitivity following trigeminal sensory nerve injury. Pain 121, 219231 (2006).

CAS PubMed Google Scholar

Xu, J.-T. et al. p38 activation in uninjured primary afferent neurons and in spinal microglia contributes to the development of neuropathic pain induced by selective motor fiber injury. Exp. Neurol. 204, 355365 (2007).

CAS PubMed Google Scholar

Cheng, H.-L. & Feldman, E. L. Bidirectional regulation of p38 kinase and c-Jun N-terminal protein kinase by insulin-like growth factor-I. J. Biol. Chem. 273, 1456014565 (1998).

CAS PubMed Google Scholar

Cheng, C. & Zochodne, D. W. Sensory neurons with activated caspase-3 survive long-term experimental diabetes. Diabetes 52, 23632371 (2003).

CAS PubMed Google Scholar

Vincent, A. M., McLean, L. L., Backus, C. & Feldman, E. L. Short-term hyperglycemia produces oxidative damage and apoptosis in neurons. FASEB J. 19, 638640 (2005).

CAS PubMed Google Scholar

Senning, E. N. & Gordon, S. E. Activity and Ca2+ regulate the mobility of TRPV1 channels in the plasma membrane of sensory neurons. Elife 4, e03819 (2015).

PubMed PubMed Central Google Scholar

Way, K. J., Katai, N. & King, G. L. Protein kinase C and the development of diabetic vascular complications. Diabet. Med. 18, 945959 (2001).

CAS PubMed Google Scholar

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Anti-hyperalgesic effects of photobiomodulation therapy (904 nm) on streptozotocin-induced diabetic neuropathy imply MAPK pathway and calcium dynamics...

Navigating cancer treatment is a challenge unlike any other. Medical professionals often advise cancer patients to lean on their support systems during treatment, and heeding that advice can make it easier to manage the ups and downs that can arise when being treated for cancer.

In addition to building a strong and trustworthy support system, individuals diagnosed with breast cancer can study up on what to expect during treatment. Side effects of treatment may differ depending on the treatment plan devised by womens cancer care teams. Such plans are not uniform, and the National Breast Cancer Foundation, Inc. notes that treatments often include a combination of therapies, including chemotherapy and radiation. In addition, no two women are the same, so they may respond differently to similar treatment plans than others have in the past. Despite the differences between treatment plans and patients, Johns Hopkins Medicine notes that women may experience an assortment of side effects, including:

Fatigue

Headaches

Pain and numbness: The pain and numbness associated with breast cancer treatment is potentially linked to peripheral neuropathy, an umbrella term that the National Institute of Neurological Disorders and Stroke says refers to the many conditions that involve damage to the peripheral nervous system. The NINDS notes that this connection is due to certain chemotherapy drugs and not all patients will develop the pain and numbness associated with peripheral neuropathy.

Dental issues: Among the potential dental issues that can arise during breast cancer treatment are mucositis (severe inflammation of the mouth), an increased risk for oral infections, difficulty swallowing, and pain that feels like a significant toothache, among others.

Lymphedema: Lymphedema is swelling in an arm or leg that the Mayo Clinic notes can be caused by cancer treatments that remove or damage the lymph nodes.

Musculoskeletal symptoms: Issues such as myalgia and muscle stiffness have been reported in a high percentage of patients who underwent aromatase inhibitor therapy for breast cancer.

Bone loss and osteoporosis

Heart problems: Breastcancer.org indicates that various types of treatment, including chemotherapy and targeted therapies, have been found to affect the heart, blood vessels and immune system, potentially increasing the risk for heart attack, stroke and heart failure.

New cancers

Cataracts

Blood clots

Absence of menstrual periods

Menopausal symptoms

Sexual difficulties: WebMD notes that a lack of sex drive, vaginal dryness and pain during intercourse are some of the sexual difficulties that can arise during breast cancer treatment.

Infertility

Concerns about memory loss and cognitive function, which is sometimes referred to as chemo brain Side effects vary during breast cancer treatment. Some women may not experience anything more than minor issues during treatment. But women are urged to discuss side effects with their cancer care teams and seek guidance about how to alleviate or overcome any symptoms that adversely affect their quality of life

Link:
Side effects that may arise during breast cancer treatment The Hamburg Reporter - Hamburg Reporter

Citizens Jury

In June 2017, we brought together a small, diverse group of citizens to address the question: Would research access to the Guthrie Card heel prick blood tests be in the public interest, and, if so, under what conditions? A Citizens Jury is a well-established method to enable public participation in policy making, allowing informed deliberation on an issue and the provision of recommendations. Our Citizens Jury followed best practice for such deliberative public engagement3. First, we convened a steering group to provide oversight of the materials prepared for the Jurors and to identify a range of expert witnesses to give evidence. Next, we consulted a Patient Participatory Involvement and Engagement (PPIE) panel to review these materials. The academic researchers did not involve themselves directly in the Jury process, other than to provide evidence or observe. The recruitment, facilitation and analysis were conducted by Ipsos MORI, Scotland, to preserve neutrality. Jurors met together for two day-long sittings to hear evidence (neutral, for and against), deliberate and reach conclusions.

Using a quota sample, a representative pool of the adult public was recruited in terms of sex, age, working status and social grade. Additional quotas were set to ensure sufficient representation of people with children under the age of five, and people with a family history of a medical condition. An attitudinal quota was set to ensure inclusion of people with varied levels of trust in public, private and third sector organisations, as previous research has found this to be a significant factor underpinning views of data sharing and use4. A total of 20 were recruited of whom 19 participated on day one, and 18 returned for the second day a week later. Jurors were given monetary recompense for taking part in each sitting.

Day One started with a warmup session sharing their views on health research and health-relevant information, followed by evidence from various experts to stimulate discussion of issues around research use of the newborn blood spots. Day Two included further expert witnesses but more time for Jurors own deliberations and to arrive at a conclusion on the key question. Facilitation tools, such as speed dating techniques, meant that all Jurors could express and reflect on their own views as well as those of others, building up to group and plenary deliberations. The first day focused on more general discussion and information sharing; the second day involved detailed deliberation of the key question and delivering of the verdict. Both days were audio recorded and transcribed for subsequent analysis. A short questionnaire was administered at the end of each day to gauge individual level views and thinking.

Background information was provided by authors SCB and DJP during the morning of Day One. Over the 2 days, six witnesses were called to give evidence and answer Jurors questions. These comprised health care professionals and scientists, a Caldicott Guardian (a person responsible for protecting the confidentiality of peoples health and care information and making sure it is used properly) and a Genewatch spokesperson (representing not-for-profit groups that monitor developments in DNA technologies). Jurors also had access to a short video and other written information about comparative deliberations and policy in California and Denmark. Having heard on Day One some of the health research opportunities uniquely possible if access were granted, an introduction to some of the social, ethical and legal issues, and how the NHS protects privacy, Jurors heard more opposing and critical views on Day Two, with one witness cautioning against allowing research access and another the importance of not compromising the newborn screening programme itself.

The Scottish newborn blood spots archive is stored in around 900 boxes each containing circa 3000 cards in a single secure location under the authority of the Director of the Scottish Newborn Screening laboratory and custodianship of the NHS Research Scotland Greater Glasgow and Clyde Biorepository. A unified digital record is in place from 2000 onwards, but the content and consistency of information available from older cards was not known at the outset. The design and information content of the newborn blood spots was known to have varied over time, but not documented. We were aware that some cards had suffered water damage prior to assembling the nation-wide archive. We also know that for a period of time some cards had been autoclaved before storage. For the vast majority, the newborn blood spots have simply been stored at room temperature. The unified newborn blood spot archive management database has limited, high-level summary information on the contents of each box.

We obtained permission from the Caldicott Guardians of NHS Research Scotland Greater Glasgow and Clyde and of Tayside to retrieve representative boxes from the NHS Research Scotland secure archive. Permission was given for (a) examination and documentation of a sub-sample from each box to provide a snap-shot of the information attached that might be required from the purposes of linkage to other routine health records and (b) sampling of cards corresponding to consented members of Generation Scotland.

Thirty boxes representing each decade from 1965 to 1999 were retrieved and examined by NHS Scotland staff at the NHS Research Scotland Greater Glasgow and Clyde Biorepository. Only summary information was shared with the rest of the study team.

The organisation and information content by box varied over time (Supplementary Fig.1). In some boxes there were unlabelled bundles of cards (Supplementary Fig.1D), but most had 4 labelled foolscap sub-boxes (Supplementary Fig.1B) with multiple, date-labelled bundles of cards (Supplementary Fig.1C).

We drew up a list of potential information that the newborn blood spots might carry from which to judge the feasibility of conducting epidemiological studies by linkage to NHS Scotland routine medical record and potentially additional consented data from research subjects.

For each box, we collected the following information: Box ID; Area Health board; Hospital; Type of card; Date of test; Child forename; Child surname; presence or absence of Community Health Index identifier. No personal information was recorded. Each box took 2 members of staff working in tandem ~2h to document.

Next, circa 1 in 100 cards from each box were examined in detail and the presence or absence of the following features documented: Child DOB; Additional comments on card; Number of blood spots; Size of spots; Mothers CHI; Mothers forename, surname and birth name; Mothers date of birth; Address; Postcode; Whether the cards had been autoclaved prior to archiving; Any other comments.

Cards from 1965 had very little information on them and in many cases did not even record the sex of the baby. Information content increased progressively over time. By the 1990s, the sex of the child and home address were generally recorded.

Over 24,000 Generation Scotland (GS) volunteers were recruited as adults between 2006 and 20115. All were born before 1993, before the digital recording of newborn blood spots began. Consent for linkage to medical records was optional but was given by 98% of volunteers. They were asked to give information about their place of birth (country and council area). A total of 8703 volunteers with linkage consent were born in Glasgow or Tayside area health boards between 1965 and 1992. The set of 30 boxes retrieved and documented for epidemiological purposes were selected on the basis that (a) Greater Glasgow and Tayside were the regions for which we had Caldicott Guardian approval and (b) they were expected to include bundles from Generation Scotland participants as the majority came for these regions. A list of names, birthplace and date of birth was extracted from the GS database and sent to the NHS Greater Glasgow and Clyde Biorepository to look for matching cards. Pseudonymous ids were added to the list so that any samples from matching cards could be labelled and linked back to the GS database after genotyping. Ninety-two matching cards were identified amongst newborn blood spots from Tayside. Of these, 58 were usable for punching having fulfilled the prerequisite of leaving one spot intact (Supplementary Fig.2). Six to ten punches were taken from each card, placed in vials labelled with a pseudonymous ID for matching to the samples donated at baseline by each Generation Scotland volunteer, and couriered to the Edinburgh Clinical Research Laboratory Genetics Laboratory for DNA analysis.

Unlike the Danish Newborn Screening Biobank (DNSB), the Scottish newborn blood spot archive comprises a variety of paper types and storage conditions, particularly for older cards. To establish the effect this might have on the recovery of analysable DNA, a pilot study in 20122014 was undertaken on a de-identified set of 136 newborn blood spots dated from 1965 to 2012 (Table1). The study was mandated by the Scottish Chief Scientist Office, following a favourable opinion from the Scottish Legal Office and North of Scotland Research Ethics Committee. De-identified cards were provided by the Scottish National Dried blood spot collection, Biochemical Genetics Laboratory, Duncan Guthrie Institute, Greater Glasgow Health Authority, Yorkhill, Glasgow. DNA was extracted from 3mm punches using the Sigma ENA kit. Yields varied from sample to sample, but there was no significant effect of date of birth and sufficient material was obtained for Sanger DNA or exome sequencing in 94% of samples (Table1). Exome sequencing used the Ion AmpliSeq exome kit run on IonTorrent Proton sequencer. Data analysis and variant calling used the IonReporter IonExpress variant caller, 4245 million mapped reads, 94.294.7% on target, mean depth 122130 reads per sample. Thirty one of 32 runs met standard QC criteria for variant analysis.

Of the 92 newborn blood spots matched to GS volunteers, 58 (63%) had sufficient dried blood spot material remaining to take 3mm diameter punch samples, while leaving at least one spot intact. These 58 were from Generation Scotland research volunteers born between 1983 and 1989 (i.e. 3238 years between collection and profiling). DNA was extracted from between 6 to 8 blood spot punches using the QIAamp DNA Investigator Kit (Qiagen; cat. no. 56504), following the manufacturers instructions. The concentration of the DNA samples was measured using a Qubit 2.0 fluorometer and the Qubit dsDNA HS assay (Thermo Fisher; cat. no. Q32854). Total yield isolated was between 196 and 1177ng of DNA. Up to 500ng DNA (range 160500ng) underwent bisulfite conversion (Zymo EZ-96). DNA methylation was profiled using the Infinium HumanMethylationEPIC v1.0 BeadChip (Illumina Inc.; cat. no. WG-317-1001), according to the manufacturers protocol (in batches of 8 samples, 56 assayed of the 58 samples processed). Arrays were scanned on an iScan and analysed using GenomeStudio v2011.1.

DNAm profiles were obtained from the 56 individuals using the Illumina MethylationEPIC beadchip, measuring ~850,000 CpGs across the genome. Quality control measures were performed, removing probes with high detection p-values (>0.05) in >5% of samples (N=52,375), or a beadcount <3 in more than 5% of samples (N=5038). Three samples were removed for having >5% of sites with a detection p-value >0.05. In addition to these standard quality control measures, additional checks were performed to ensure newborn blood spots and baseline samples matched with regard to predicted sex and genotype (Supplementary Information Methods, Supplementary Figs.3 and 4 and Supplementary Table1). Quality control and analysis code have been deposited in a public repository6. To access Generation Scotland data, including the data derived in the feasibility study described here, please go to http://www.ed.ac.uk/generation-scotland/for-researchers/access.

Confirmatory analyses were performed using newborn blood spots DNA methylation data to ensure predicted sex (using X-chromosome data) and genotype (using rs control probes on the EPIC array) were consistent with peripheral blood-based genotyping and DNA methylation data on samples collected at baseline recruitment (20062011) (Supplementary Table1). Detailed information on sample checks is presented inSupplementary Information Methods and Supplementary Figs.3 and 4.

An individuals smoking status can be reliably predicted using composite DNA methylation-derived smoking scores, and effects have also been observed in the offspring of mothers who smoked during pregnancy7. Moreover, information from a single probe in the aryl-hydrocarbon receptor repressor gene (AHRR; cg05575921) can serve as a robust marker of smoking, with lower DNA methylation levels associating with current smoker status. Maternal smoking status at the time of sample collection was derived from smoking status at GS baseline, and the years stopped variable for former smokers, where both mother and baby are in GS. DNA methylation-based estimates of smoking status were obtained, using previously validated methods8. A composite score for smoking status (EpiSmokEr) was obtained using Guthrie sample DNAm data and, along with cg05575921 DNA methylation levels, was plotted against maternal smoking status at the time of sampling (Fig.1). Consistent with previous literature, a higher overall value was observed for the EpiSmokEr score in the offspring of current smokers whereas a lower overall value was observed for the offspring of never smokers, supporting an association at the population level (Fig.1a; ever smoker =0.78; sex-adjusted linear regression P=0.026). DNA methylation levels at cg05575921 were also consistent with the literature, with lower overall levels in the offspring of current smokers relative to never smokers (Fig.1b; ever smoker =0.72; sex-adjusted linear regression P=0.05).

Methylation-derived smoking scores from newborn blood spot DNA (y-axis) plotted against maternal smoking status (current, former, never) at time of birth (NCurrentSmokers=10; NFormerSmokers=5; NNeverSmokers=26). Results are shown for the EpiSmokEr score, a composite measure comprised of multiple CpG sites (a), and DNA methylation levels at a single CpG (cg05575921) in the AHRR gene (b). Upper and lower hinges correspond to the upper and lower quartiles, respectively. Whiskers extend to data points as far as 1.5 times the interquartile range. Outlying data points are defined as those beyond the whiskers. Thick horizontal lines represent the median.

The original Sanger DNA and exome sequencing study was mandated by the Scottish Chief Scientist Office, following a favourable opinion from the Scottish Legal Office and the North of Scotland Research Ethics Committee, REC ref. 11/ns.0014. A letter approving the inspection and documentation of newborn blood spots and selective sampling of GS cards for methylation analysis was provided by the Chief Medical Officer for Scotland on 4 September, 2019. The Caldicott Guardians of NHS Greater Glasgow and Clyde and NHS Tayside granted approval on 30 January 2020 and 3 March 2020, respectively. Volunteers for Generation Scotland gave informed consent at the time of recruitment for biological studies, including genetic studies, on their biological samples and for linkage to medical records. A substantial amendment to the Research Tissue Bank approval for Generation Scotland to cover the feasibility study was submitted to the East of Scotland Research Ethics Committee and approved on 13 March 2020.

The Citizens Jury followed INVOLVE guidelines and was conducted by the polling organisation, Ipsos MORI, on behalf of the University of Edinburgh research team. This work was carried out in accordance with the requirements of the international quality standard for Market Research, ISO 20252:2012, and with the Ipsos MORI Terms and Conditions which can be found at http://www.ipsos-mori.com/terms. Ipsos MORI conducted their own internal ethical review through their ethical review team. The Ipsos MORI Project Director (CM) was then responsible for ensuring that the research materials (recruitment screener, participant information sheets, discussion guides) were clear and met the ethics principles on informed consent, right to refuse, principles of anonymity and confidentiality. No sensitive information was collected. Materials were saved in a secure folder with access restricted to the Ipsos MORI team (CM, SD). After completion, all personal information (participant names, contacts details, recordings and transcripts) were securely destroyed using Ipsos MORI digital shredding software.

Further information on research design is available in theNature Research Reporting Summary linked to this article.

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Feasibility and ethics of using data from the Scottish newborn blood spot archive for research | Communications Medicine - Nature.com

There is not a single, universal blueprint for closing down a health care practice. Requirements often differ slightly based on state law and circumstance. That said, in order to make the process go smoothly to minimize any potential risk or liability, there are some general guidelines that health care providers should be aware of prior to closing down a practice.

Notification

There are several parties that a practice may be required to notify prior to its closing. These parties include, but are not limited to: patients, federal and state agencies and licensing boards, employees, payors, vendors, and other business associates. Each party has unique notification requirements, subject to relevant law and custom.

Notification to Patients

Notification to patients normally must occur between one and three months prior to the closing date to avoid claims of abandonment. Notification should be given to all active patients, which depending on your state, can be any patient the physician has treated sometime in the past 12-36 months. The timing and method of notification can differ based on the health status of the patient. For example, high risk patients may need the notice to be sent via certified mail so the practice can track whether it was received or, if undeliverable, the practice can record that an attempt was made to reach the patient in an effort to minimize risk of any claim to the contrary.

In each case, the notice to patients will need to include certain information. This information will likely include the date of closing, the name(s) of local physicians that would be willing to accept new patients, the name of the physician(s) taking over the practice (if applicable), instructions for how to obtain or transfer medical records and a deadline for submitting record requests, new contact information for the departing physician, a way to contact the practice regarding any questions or concerns patients and their families may have in regards to the practice closing, and information regarding where the medical records will be stored after the practice closing. Providing thorough and accurate notice to patients will help address any confusions patients or their families may have, and hopefully reduce any complications going forward.

Some states, such as Illinois, require the notice to be published as an advertisement in the local newspaper. States that have this requirement will specify the period of time prior to closing the advertisement needs to be published and how long the advertisement will need to run. Notification also should be posted throughout the practice, and patients who call or visit should be given verbal reminders.

Notification to Employees

It is important to notify practice employees. It is best that employees hear about the closing from the practice directly and that they are notified early in the process. Practices can incentivize employees to stay until the practice is officially closed, but should be prepared to hire temporary help should employees decide to leave prior to the closing date.

Notification to Entities

When closing a practice, certain federal, state and local agencies and organizations may need to be notified. Each entity will have different requirements, so it is important to be familiar with these requirements or consult with a local expert. For example, notification to the Federal Drug Enforcement Agency (DEA) must be in writing and specify whether you wish to continue or surrender the DEA registration. Also, providers are required to notify the Centers for Medicare & Medicaid Services no later than 90 days after a decision to retire or withdraw from the Medicare program.

Notification also should be made to the practices malpractice insurance carrier and any other insurance carriers that contract with the practice (for example, workers compensation policy or as part of any employee benefit plans). If the practice is affiliated with any hospitals, referring physicians, state and local medical societies, insurers or managed care companies, they also should be given notice.

As with any winding up of a business, it is important to review contracts to which the practice is a party. Contracts, for cleaning services, waste disposal, internet, laboratory services, and the like may require notice in writing of termination and could have penalties for early termination. The same goes for termination or assignment of any lease agreements. If the practice owns the space where it is located, it will need to determine if the space will be sold or leased to a new business.

Record Retention

While the medical record itself generally is understood to be the property of the practice, the information contained in the record is the property of the patient. As such, the practice should obtain HIPAA-compliant authorizations to transfer records at the patients request. Where records are not transferred, they will need to be stored by the practice for a period of time. Some states have specific record retention requirements. Indiana, for example, requires that all records must be retained and kept confidential by the practitioner for at least seven years.

If your state does not have a required period of retention, a good general rule is to arrange to store adult medical records for seven to ten years. For minors, good practice is to retain medical records until they reach the age of 21 years and the length of time the practice retains adult records has gone by since the last treatment date.Medicare and Medicaid records should be retained in their original form for at least ten years.In any case, it is important that records be available for the period prescribed by your states malpractice statute of limitations.

In some states, a state archive or health department will store health records from closed facilities. However, it is more common that records are transferred to another healthcare provider or stored physically in a HIPAA-compliant storage facility or electronical repository. Whether records are held in a storage facility or transferred to another healthcare provider, it is important to notify patients of the storage location and instruct them as to how to obtain records after the practice has closed. Any records that can legally be destroyed should be shredded or otherwise destroyed in a HIPAA-compliant fashion.

Insurance

Closing a practice does not exempt it from liability for anything that may have occurred while the practice was active. The practice will need to ensure that both it and its providers are covered by liability insurance through a tail policy or some other form of continuing coverage. If a provider is retiring and has been with his or her malpractice carrier for a certain period of time, it may be possible to obtain tail coverage for little or no cost.

Additional Considerations

Make sure to collect accounts receivable. The practice may need to arrange for another physician to collect remaining accounts or turn past due accounts over to a collection or billing agency.

Be sure to repay all debts and liabilities and pay malpractice premiums. Once all liabilities have been paid, practice owners will need to determine how to distribute any remaining income. It is recommended that the practice retain some funds for a period of time to cover the cost of surprise or otherwise unknown liabilities that may present at a later date.

It is recommended that the practice consult with legal counsel to complete certain legal documents to properly dissolve the practice entity with the state of formation. Further, the practice should consult with its accountant to make sure any tax-related issues are addressed.

Conclusion

Closing a medical practice may seem like a challenging task. While there are a number of components to consider, it does not need to be an overwhelming experience. By keeping these guidelines in mind, and consulting the necessary experts, a practice can create and execute a plan that allows for a seamless transition and minimizes future legal implications.

Christina M. Kuta, J.D., LL.M., M.S.W., is of counsel in the Health Law group atRoetzel& Andress in Chicago. She can be reached atckuta@ralaw.com.

Delaney Perl, J.D., is an associate in the Health Law group atRoetzel& Andress in Chicago.

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Closing your health care practice: What you need to know - Medical Economics

Survey shows that alternative sites for care are gaining popularity with consumers

When it comes to where Americans prefer to receive their care, retail clinics, virtual health, and community centers are all growing in popularity, according to a survey from the Deloitte Center for Health Solutions. These changes reflect patient preferences to have health care be more similar to other consumer retail experiences.

There is a growing desire to use retail clinics, and this is especially true among underserved populations, according to the survey. Only 10% of consumers have used a retail clinic in the past year, but many more say the would be likely to or maybe would use retail clinics for preventive care (55%) or mental health care (47%). Black, Asian, and Hispanic respondents were more likely than White respondents to use retail clinics, and urban respondents were more likely than rural ones.

Virtual care, which became popular during the worst months of the pandemic, continues to be popular with patients. Nearly three in four consumers with Medicaid (74%) or HIX plans (73%) would use virtual health for mental health visits, and nearly two-thirds of all consumers would use virtual visits for preventive care.

According to the report, health care organizations looking to stay relevant need to take several steps. They should create more access points and include opportunities to address the drivers of health. They need to develop diverse care teams, ensure care continuity, and invest in virtual health technology and training.

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Is the doctor's office heading for extinction? - Medical Economics

On June 24, 2022, the Supreme Court of the United States overturned Roe v. Wade, the landmark 1973 decision that established a constitutional right to abortion across the country.

As a result of the ruling, individual states have the ability to set their own abortion laws.

Now some states have passed laws to restrict abortion to certain points in pregnancy or virtually ban it nearly altogether.

Some of those restrictions have been temporarily blocked due to court challenges.

Voters in some states will also have the opportunity to vote on abortion-related ballot measures in the upcoming midterm elections.

This round-up provides an overview of the current legal status of abortion in all 50 states and Washington, D.C. The information in this article was accurate and up to date at the time of publication, but its possible that some information has since changed.

To learn about your legal rights, consider contacting the Repro Legal Helpline through a secure online form or by calling 844-868-2812.

Here are some common terms that you might come across while learning about abortion laws:

In Connecticut, abortion is legal and unrestricted until a pregnancy reaches viability. After viability, abortion is only legal if your physical or mental health or life is in danger.

Additional restrictions:

In Delaware, abortion is legal until a pregnancy reaches viability. After that, abortion is only legal if:

Additional restrictions:

In Maine, abortion is legal and unrestricted until a pregnancy reaches viability. After that, abortion is only legal if your physical or mental health or life is in danger.

Additional restrictions:

In Massachusetts, abortion is legal before 24 weeks of pregnancy. From week 24 onwards, its only legal if:

Additional restrictions:

In Maryland, abortion is legal until a pregnancy reaches viability. After viability, abortion is only legal if:

Additional restrictions:

In New Hampshire, abortion is legal before 24 weeks of pregnancy. From 24 weeks onwards, its only legal if:

Additional restrictions:

Abortion is legal and unrestricted in New Jersey.

Additional restrictions:

In New York, abortion is legal and unrestricted until a pregnancy reaches viability. After that, abortion is only legal if your physical or mental health or your life is in danger or if the fetus will not survive.

Additional restrictions:

In Pennsylvania, abortion is legal before 24 weeks of pregnancy. From week 24 onwards, its only legal if your physical health is at serious risk or your life is in danger.

Additional restrictions:

In Rhode Island, abortion is legal until a pregnancy reaches viability. After viability, abortion is only legal if its necessary to save your life.

Additional restrictions:

Abortion is currently legal and unrestricted in Vermont. You can legally get an abortion at any stage of pregnancy.

Voters in Vermonts midterm elections will have the opportunity to vote on a constitutional amendment to protect the right to abortion in the state.

Additional restrictions:

Abortion is currently legal and unrestricted in Washington, DC. You can legally get an abortion at any stage of pregnancy.

Additional restrictions:

In Alabama, abortion is banned with very limited exceptions. Its only legal if its necessary to prevent serious risks to your physical health or save your life. Theres no exception for rape or incest.

In Arkansas, abortion is banned with very limited exceptions. Its only legal if its necessary to save your life. Theres no exception for rape or incest.

In Florida, abortion is legal until 15 weeks of pregnancy. After that, its only legal if:

Theres no exception for rape or incest.

Abortion providers are suing to block the ban on abortion after 15 weeks.

Additional restrictions:

In Georgia, abortion is legal until a so-called fetal heartbeat is detected, around 6 weeks of pregnancy.

At six weeks of pregnancy, embryos dont have hearts just cells that emit an electrical charge, which can be detected on an ultrasound.

After that, abortion is only legal if:

Additional restrictions:

In Louisiana, abortion is banned with very limited exceptions. Its only legal if:

Theres no exception for rape or incest.

In Mississippi, abortion is banned with very limited exceptions. Its only legal if:

In August 2022, a US district court judge in North Carolina allowed a 2019 abortion law to go into effect. Under this law, abortion is legal up to 20 weeks of pregnancy. After that, its only legal if your health or life is in danger.

Additional restrictions:

In June 2022, South Carolina passed a law to ban abortion after a so-called fetal heartbeat is detected, which typically happens around 6 weeks of pregnancy.

At six weeks of pregnancy, embryos dont have hearts just cells that emit an electrical charge, which can be detected on an ultrasound.

However, the South Carolina Supreme Court has temporarily blocked that law.

While that law is blocked, abortion is legal before 22 weeks of pregnancy. From 22 weeks onwards, its only legal if:

Additional restrictions:

In Tennessee, abortion is banned with very limited exceptions. Its only legal if:

Theres no exception for rape or incest.

In Kentucky, abortion is currently banned with very limited exceptions. Abortion is only legal if its necessary to prevent serious risks to your physical health or save your life. Theres no exception for rape or incest.

In Novembers midterm elections, Kentucky voters will be asked to vote on a ballot measure to establish that the state constitution does not recognize or protect a right to abortion.

In Virginia, abortion is legal before 27 weeks of pregnancy. From week 27 onwards, its only legal if your physical or mental health or your life is in danger.

Additional restrictions:

As of September 16, 2022, abortion is banned with very limited exceptions in West Virginia.

Its only legal if:

In Illinois, abortion is legal until a pregnancy reaches viability. After viability, abortion is only legal if your health or life is in danger.

In August 2022, Indiana legislators passed a law to ban nearly all abortions. It was scheduled to come into effect in September. However, its currently being challenged in court and has been temporarily blocked.

While that law is blocked, abortion is legal before 22 weeks of pregnancy. From week 22 onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

Currently, abortion is legal before 22 weeks of pregnancy in Iowa. From 22 weeks onwards, its only legal if your physical health or life is in danger.

In 2018, Gov. Kim Reynolds (R) signed a more restrictive law that would only allow abortion until a so-called fetal heartbeat is detected, around 6 weeks of pregnancy. A Polk County district court blocked that law from coming into effect. Now, Gov. Reynolds is asking the court to reinstate the law.

At six weeks of pregnancy, embryos dont have hearts just cells that emit an electrical charge, which can be detected on an ultrasound.

Additional restrictions:

In August 2022, Kansas voters rejected a ballot measure that would have removed abortion protections from the state constitution.

In Kansas, abortion is legal before 22 weeks of pregnancy. From 22 weeks onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

Abortion is currently legal in Michigan until a pregnancy reaches viability. After viability, its only legal if its necessary to save your life.

Voters in Michigans midterm elections will have the chance to vote on an amendment to protect the right to abortion in the states constitution.

Additional restrictions:

In Minnesota, abortion is legal until a pregnancy reaches viability. After viability, its only legal if your physical or mental health or your life is in danger.

Additional restrictions:

In Missouri, abortion is banned with very limited exceptions. Its only legal if your physical health is at serious risk or if its necessary to save your life. Theres no exception for rape or incest.

In Nebraska, abortion is legal before 22 weeks of pregnancy. From 22 weeks onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

Before Roe v. Wade was overturned, North Dakota passed a trigger law that would ban nearly all abortions. However, after an abortion provider filed suit to challenge the ban, a judge temporarily blocked it before it could come into effect.

While that law is blocked, abortion is legal before 22 weeks of pregnancy. From week 22 onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

In June 2022, Ohio passed a law to ban abortion after a so-called fetal heartbeat is detected, which typically happens around 6 weeks of pregnancy. However, that fetal heartbeat law has been temporarily blocked and is currently being challenged in court.

At six weeks of pregnancy, embryos dont have hearts just cells that emit an electrical charge, which can be detected on an ultrasound.

While that law is blocked, abortion is legal before 22 weeks of pregnancy. From 22 weeks onwards, its only legal if your physical health or life is in danger.

Additional restrictions:

In South Dakota, abortion is banned with very limited exceptions. Its only legal if your physical health is at serious risk or its necessary to save your life. Theres no exception for rape or incest.

When Roe. v. Wade was overturned, a long-dormant 1849 Wisconsin law came into effect. Under this law, abortion is only legal if your health or life is in danger. Theres no exception for rape or incest.

Attorney General Josh Kaul (D) is currently suing public officials to block the enforcement of this law. If hes successful, abortion will be legal before 22 weeks of pregnancy. From 22 weeks onwards, it will only be legal if its necessary to prevent serious risk to your physical health or save your life.

On September 23, 2022, a state judge reinstated a law from 1864 that bans abortion with very limited exceptions. As a result, abortion is only legal in this state if its necessary to save your life. Theres no exception for rape or incest.

Before this ruling, state legislators had passed a law that would allow abortion up to 15 weeks of pregnancy.

Abortion is legal and unrestricted in New Mexico. You can legally get an abortion at any stage of pregnancy.

Additional restrictions:

In Oklahoma, abortion is banned with very limited exceptions. Its only legal if its necessary to save your life. Theres no exception for rape or incest.

In Texas, abortion is banned with very limited exceptions. Its only legal if its necessary to prevent serious risk to your physical health or save your life. Theres no exception for rape or incest.

In Alaska, abortion is legal at any stage in pregnancy.

Additional restrictions:

In Novembers midterm elections, Californians will be invited to vote on an amendment to enshrine the right to abortion in the states constitution.

Abortion is currently legal and unrestricted until a pregnancy reaches viability. After viability, abortion is only legal if your health or life is in danger.

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Abortion Access in the U.S.: What to Know on a State-By-State Level - Healthline

Leila Ladaniis on a mission to cultivate a human-centered mindset to guide the design and manufacturing of biomedical devices and implants.

Ladani, a professor in theSchool for Engineering of Matter, Transport and Energy, part of theIra A. Fulton Schools of Engineeringat Arizona State University, is among pioneering biomedical engineers advancing the understandings of how devices can be used more effectively in clinical settings. ASU Professor Leila Ladani (left) works with student Carol Lu (right) in her research lab to develop a biomedical device to determine the presence of cancer in tissue margins during a lumpectomy, which will streamline the cancer removal process and reduce the need for re-excision. Photo courtesy Leila Ladani Download Full Image

Ladani was recently awarded a$3 million grantfrom theNational Science Foundation Research Traineeship Program to develop a new biomedical device manufacturing training program at ASU. Her project, Design and Manufacturing of Medical Devices and Implants: Cultivating a Human-Centered Mindset, will connect engineering students with health care professionals and patients to introduce them to the ethical principles, laws and policies associated with the development and use of biomedical technologies.

We want to put the users right at the forefront of innovation because the users are patients or clinicians, Ladani says. We want to make sure that what we are designing and manufacturing is something that they can actually use, with the mindset that human society is very complex.

Ladani was also recently nominated by ASU Provost Nancy Gonzales to participate in the ELATES leadership development program at Drexel University. The program is designed to support senior female faculty members and allies of all genders in STEM-related fields to hone their leadership effectiveness. Ladani was one of only 30 people to be selected for this years nationwide cohort. Over the course of the yearlong fellowship program, she will attend multiple in-person and online meetings with peers as each attendee develops an institutional action plan to advance a mission of their choosing.

During the process of developing her own biomedical device, Ladani discovered a knowledge gap between biomedical engineers and the communities they serve.

In collaboration withMayo Clinicand one of its well-known surgical oncologists,Dr. Barbara Pockaj, Ladani is developing a device to determine the presence of cancer in tissue margins during a lumpectomy the surgical removal of a portion, or lump, of breast tissue, typically as a treatment for a malignant tumor or breast cancer.

ASU Women and Philanthropyis funding the development of the device, which will streamline the cancer removal process and reduce the need for re-excision.

With the intention of using the device in the operating room during surgery, Ladani realized the complexity of the clinical setting may not allow her current design to be used efficiently.

We needed to make sure the device could detect the location of the cancer accurately and make it easy for the doctors to be able to read the results while they were operating. I figured out that theres a big gap in theory and practice, Ladani says. We develop these innovations in the lab, but we dont really know what makes a device effective unless we have a close connection with the medical side.

Motivated to improve the experience of innovators who might encounter similar situations, Ladani began developing a program that would introduce STEM students to the nuances of device manufacturing. Program team members include faculty at ASU, includingKatina Michael,Jafar Razmi,Kaushal Rege,Karen Anderson,Jean AndinoandRick Hall, as well as Dr. Steven J. Lester, a cardiologist, professor of medicine, and founder and chief medical officer of theMayo Clinic-Arizona State University MedTech Accelerator.

The teams new biomedical device manufacturing program is built on a set of multidisciplinary and convergent research areas, which also builds on the strong relationship between ASU and Mayo Clinic and theMayo Clinic and Arizona State University Alliance for Health Care.

This endeavor represents an important facet in ASUs quest for excellence in which achieving a convergence of disciplines is a key imperative,ASU President Michael Crowsaid in support of the program.

Dr. Rafael Fonseca, chief innovation officer at Mayo Clinic, also strongly supports Ladanis project.

Training engineers who understand the practical limitations of their discoveries and inventions is critical in advancing solution-oriented discoveries, Fonseca says.

To effectively engage students in STEM with the medical aspects of their disciplines, they will connect with Mayo Clinic providers and key collaborators who are interested in the students prospective biomedical technologies or devices to shadow them for a semester.

This process helps create a foundation for truly use-inspired technology development, Lester says. The program is a wonderful example of the collaboration between Mayo Clinic and ASU, which work together to create an intellectual ecosystem with expertise from every area of health care.

Through the programs curricular components, including applied and experiential learning and entrepreneurial activities, students will develop their ideas for biomedical devices. Then, under the guidance of experts, students go through the processes of disclosure and filing patents, involving all the steps necessary to commercialize their innovative products.

The goal is to help students develop a sustainable, scalable product, taking into consideration legal, regulatory, compliance and reimbursement issues. The entrepreneurial focus opens the possibility for some of the students ideas, leading them to establish their own medical device companies.

The program also provides support for doctoral students through stipend and tuition coverage.

As a part of the project, Ladani is creating a new structured mentorship program for students at all levels. The Graduate-Undergraduate Mentorship program will give graduate students opportunities to spend a summer mentoring undergraduate students interested in developing their own devices.

Ladani and her team are also developing new courses to acquaint students with the ethical and regulatory aspects associated with medical devices and implants. The program will also include components like seminars, orientations, retreats and presentations from guest speakers in industry and academia.

Though doctoral students will spend only two years in the program, the community they build during their time as participants is intended to last a lifetime.

These students will have a breadth of understanding in several different areas that will impact their design work, Ladani says. With the information they gain, they will be more equipped to start their own companies to create devices as well as jobs.

The program will enable students to design next-generation medical technologies that enhance care delivery and patient outcomes.

Doctoral students from all engineering disciplines are encouraged to apply via an online portal set to launch in spring of 2023. Interested students can contact Ladani atladani@asu.edu.

Link:
Students can create their own path with new ASU Online biology degree - ASU News Now

Dr. Lance Eliot, an expert on AI & Law currently serving as a Stanford Fellow, argues that while the new US AI Bill of Rights is not a game changer, it is a step in the right direction...

What rights should we have in a society increasingly being scrutinized, monitored, and controlled via the use of Artificial Intelligence (AI)?

Thats a good question.

To address this thorny and unresolved legal issue, the US White House released on October 4, 2022, a white paper informally referred to as anAI Bill of Rights, which more officially is entitled Blueprint for an AI Bill of Rights: Making Automated Systems Work for the American People. The document is the work of the Office of Science and Technology Policy (OSTP), a federal entity that was established in the mid-1970s and serves to advise the American President and the US Executive Office on various technological, scientific, and engineering aspects of national importance.

Lets unpack the AI Bill of Rights and examine the pros and cons of this latest pronouncement pertaining to AI and the law.

Rightfully Thinking About AI And Human Rights

The naming of this as an AI Bill of Rights is a bit askew since it might inadvertently suggest that these are rights associated with AI systems that are considered reaching sentience or otherwise nearing a point of legal personhood. Not so. To clarify, this 73-page long document is abouthuman rightsamid the ongoing onslaught of AI systems that are being deployed without sufficient attention to humankinds safety and well-being.

You might be aware that AI has been put into use by numerous private and public organizations and has ended up acting in a variety of discriminatory ways. Our civil rights and civil liberties are under attack by how AI is crafted and utilized. AI at times is ruinously undercutting data privacy. AI permeates all manner of social media and can wrongfully suppress the speech of those criticizing hate speech, ironically so. AI can be used to stalk someone across both electronic and physical worlds, endangering their personal safety.

On and on, the litany of AI endangerment goes.

A technical companion portion within the AI Bill of Rights describes dozens of real-world examples showcasing how AI is being improperly devised and fostering potential harm. The examples suffice to get the hair standing on the back of your neck. As an additional harbinger of concern, keep in mind that AI is expansively being rolled out and will ultimately be ubiquitous. You can anticipate a non-stop barrage of AI amidst nearly all of our daily apps on our smartphones and likewise AI-powered applications used by major companies and by governmental agencies.

If we are inexorably going to be immersed in an AI-permeated way of existence, the logical response is to stand up for the rights of humankind. Thus, the reasoned basis to forge an AI Bill of Rights that can valiantly protect people.

The US Constitution famously has a historic Bill of Rights that includes vital guarantees of personal freedoms and mindfully addresses the codification of legally stipulated rights. The first ten amendments of the Constitution are breathtaking in their scope and significance. This AI Bill of Rights attempts to leverage the revered nature of the Bill of Rights to draw public attention to what needs to be considered in an AI era (some might readily criticize trying to somewhat exploit the famed Bill of Rights in this naming manner, perhaps overstepping a proper sense of decorum, though it could be a small price to pay for engaging society in the upcoming AI legal morass).

The AI Bill of Rights posits five keystones (excerpts quoted from the official white paper as cited earlier):

AI that is programmed by humans can contain a plethora of hidden risks.

I am not alluding to existential risks such as AI that rises and takes over humanity (we arent yet in that ballpark). The kind of AI that is being confronted consists of non-sentient algorithmic AI. Efforts to legislatively contend with algorithmic AI include the U.S. Congressional ongoing efforts toward crafting the Algorithmic Accountability Act, while in the European realm there is the EU Artificial Intelligence Act (AIA) currently under review.

An Appetizer But Not A Meal

You would be hard-pressed to argue against the proposed precepts of the newly unveiled AI Bill of Rights. The five keystones are indubitably sensible. It is possible to quibble with some of the wording here or there, but overall, the indicated protections are what we need to be diligently considering.

That being said, the AI Bill of Rights has perhaps only whetted our appetite. Envision that this is the precursor or appetizer leading up to a fuller meal.

We have already seen this appetizer in other guises, such as the US Department of Defense (DoD) officially statedEthical Principles of AI and even the somewhat comparabledirectivesby the Vatican in itsRome Call For AI Ethics. A much more extensive elucidation of these types of AI-relevant humankind rights was well-documented in theRecommendation on the Ethics of Artificial Intelligence released last year by UNESCO (United Nations Educational, Scientific, and Cultural Organization) which garnered adopted approval by 193 member countries of the United Nations [8].

In that sense, the AI Bill of Rights has a lot to draw upon and yet also measure up to.

The AI Bill of Rights can be said to be insufficient in many ways, including but not limited to:

Despite those aforementioned insufficiencies, there is certainly something to be said about trying to place a stick in the ground and get the ball rolling on the regulatory governance of AI. Apparently, selected areas of the U.S. federal government will attempt to try out the five keystones of the AI Bill of Rights (as suggested in the white paper as part of leading by example). The belief seems to be that this will illuminate the efficacy of the keystones and reveal ways to bolster and sharpen them.

Lawmakers are ultimately going to be in the drivers seat on all of this.

Those tasked with making our laws are going to be immensely challenged with the complicated chore of bringing together a veritable smorgasbord of recommended soft-law AI ethical practices and patchwork hard-law AI laws that are springing up throughout the states. Furthermore, our lawmakers should be wisely eyeing the globally emerging AI soft-laws and AI hard-laws that are available for the world to see and reuse.

Make no mistake, all of this is a burgeoning part of the law and growth is abundant.

Attorneys and law students will soon see that AI & Law is bubbling up to the surface. As more AI is devised and unleashed, companies and governments will need to seek out savvy AI-aware legal advisors. Meanwhile, the coming glut of new or imagined AI laws will require legal minds that can ensure that the laws as codified are sensible and practical. And the potential harms produced by AI will require lawyers that are willing to fight for humankinds rights against the blitz of dour AI systems.

Per the wisdom of Louis Brandeis, former Associate Justice of the U.S. Supreme Court: If we desire respect for the law, we must first make the law respectable.

Lets all get into the action and make humankinds rights associated with the advent of AI a top priority. It assuredly seems like a respectable thing to do.

About The Author

Dr. Lance Eliot is a global expert on AI & Law and serves as a Stanford Fellow affiliated with the Stanford Law School (SLS) and the Stanford Computer Science Department via the Center for Legal Informatics. His popular books on AI & Law are highly rated and he has been an invited keynote speaker at major law industry conferences. His articles have appeared in numerous legal publications includingMIT Computational Law Journal, Robotics Law Journal, The AI Journal, Computers & Law Journal, Oxford University Business Law (OBLB), New Law Journal, The Global Legal Post, Lawyer Monthly, Legal Business World, LexQuiry, The Legal Daily Journal, Swiss Chinese Law Review Journal, The Legal Technologist, Law360, Attorney At Law Magazine, Law Society Gazette, and others. Dr. Eliot serves on AI & Law committees for the World Economic Forum (WEF), United Nations ITU, IEEE, NIST, and other standards boards, and has testified for Congress on emerging AI high-tech aspects. He has been a professor at the University of Southern California (USC) and served as the Executive Director of a pioneering AI research lab at USC. He has been a top executive at a major Venture Capital (VC) firm, served as a corporate officer in several large firms, and been a highly successful entrepreneur.

Acknowledgment

This research is part of an ongoing initiative on AI & Law and thanks go to the Stanford University CodeX Center for Legal Informatics, a center jointly operated by the Stanford Law School (SLS) and the Stanford Computer Science Department. CodeX s emphasis is on the research and development of computational lawthe branch of legal informatics concerned with the automation and mechanization of legal analysis.

Suggested citation: Lance Eliot, U.S. Releases An AI Bill Of Rights That Though Encouraging Wont Yet Move The Needle, JURIST Academic Commentary, October 5, 2022, https://www.jurist.org/commentary/2022/10/u-s-releases-an-ai-bill-of-rights-that-though-encouraging-wont-yet-move-the-needle/.

This article was prepared for publication by Ingrid Burke-Friedman, Features Editor. Please direct any questions or comments to her at commentary@jurist.org

Opinions expressed in JURIST Commentary are the sole responsibility of the author and do not necessarily reflect the views of JURIST's editors, staff, donors or the University of Pittsburgh.

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U.S. Releases an AI Bill Of Rights That Though Encouraging Won't Yet Move the Needle - JURIST

California officials announced on Wednesday that the state will be awarding up to $20 million in marijuana tax-funded grants to universities that carry out research into cannabis science and policyincluding studies on preventing monopolies in the legal industry and securing the genetics of legacy strains.

This is the second round of academic marijuana grants from the Department of Cannabis Control (DCC), which said it is soliciting research proposals from public colleges with a focus on five priority study areas.

The department said that it developed the top research priorities in consultation with other state agencies, seeking to learn more about the implementation of cannabis legalization from economic vitality to public health to preservation of the states cannabis heritage.

Regulators previously issued $30 million in marijuana research grants to public universities across the state in 2020.

For this new round, DCC said it is looking for solicitations for projects that deal with cannabis potency and cannabinoid analysis, the health of the states marijuana industry, monopolies and unfair competition, legacy cannabis genetics and data on medical marijuana use.

California continues to direct millions of dollars to accelerate scientific understanding of cannabis and evaluate the impacts of legalization, DCC Director Nicole Elliott said in a press release. Decades of federal cannabis prohibition has hindered our collective knowledge related to these issues, to the detriment of consumers, communities, our environment and more.

Our hope is that research resulting from these grants proves beneficial not only to California policymakers but also to those across the nation and world, she said.

One of the more notable research objectives concerns anti-competitiveness in the industrya topic of growing interest as state markets across the U.S. have increasingly consolidated, raising concerns about the future of small cannabis businesses.

DCC said its seeking research and recommendations related to possible policies that would support reasonable competition, reduce anti-competitive behavior, uphold the ability of small businesses to compete in the legal market, or prevent the creation of monopolies within the California market.

California also seems to be leaning into its unique marijuana culture and economy by soliciting study proposals to identify and preserve the history, value and diversity of California legacy cannabis cultivars and the rich experience of its legacy cultivation community.

DCC said that genetic sequencing and chemical profiling of those legacy strains (e.g. Granddaddy Purple) could be part of that research.

Although grant funding is not limited to the identified topics, their prioritization provides additional direction to prospective grantees eager to help state cannabis leaders close gaps in research, the department said. The resulting research and data would continue to inform and support the creation of a safe, sustainable, and equitable cannabis market that protects people, safeguards the environment, and provides adult access to safe, tested products.

Study proposals will be accepted from November 1-30, and grant awardees will be announced in February 2023.

The academic funding opportunity was announced just days after California officials said that they would be accepting another round of applications for grants to support local efforts to promote equity in the marijuana industry.

The Governors Office of Business and Economic Development (GO-Biz) started accepting applications for an earlier round of grants under the programaround this time last year, with a total of $35 million made available for localities across the state. This years funding cap is set at $15 million.

The department separately distributeda round of community reinvestment grantsearlier this year totaling $35.5 million with tax revenue generated from recreational marijuana sales.

GO-Biz announced in July that theyve awarded 78 grants to organizations throughout the state that will support economic and social development in communities disproportionately impacted by the war on drugs. The amount of funding and number of recipients for that programincreased from last years levels, when the state awarded about $29 million in grants to 58 nonprofit organizations through the CalCRG program.

Meanwhile, the state is also taking steps to bring more marijuana businesses above board as it continues to mitigate the illicit market.

California started granting provisional marijuana business licenses as a way to more quickly stand up the adult-use market. That temporary licensing category was set to expire last year, but it was extended to give localities more time to complete the permitting process and meet environmental requirements.

Since then, the state has identified a number of jurisdictions that may need additional support to get those provisional licensees into the traditional, annual license category. A separate grant program run by the Department of Cannabis Control (DCC) is providing that licensure funding.

Ensuring that localities are able to effectively stand up a regulated industry is especially important in California, where more than half of the states jurisdictions havebanned cannabis businesses from operating in their area, which has helped sustain the illicit trade.

Gov. Gavin Newsom (D), along with regulators and lawmakers, have attempted to resolve the issue through different means.

The governor has signedabout a dozen pieces of cannabis reform legislationin the past month, including one proposal that will prevent localities from blocking medical cannabis deliveries, along with measures on interstate cannabis commerce, employment protections for consumers and record sealing of past convictions.

Marijuana Moment is tracking more than 1,500 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they dont miss any developments.Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

The legislaturedelivered numerous cannabis bills to Newsomnear the end of the session, and he acted on the majority of them in one fell swoop last month. The governor said the reforms were necessary to help fulfill the promises of legalization and continue to address the collateral consequences of prohibition.

Newsom as a long record of supporting marijuana reform and backing the states market, so hes generally been expected to sign reform measures delivered to his desk. But despite his record, he recentlyvetoed a key piece of drug policy reform legislationthat would have authorized a safe drug consumption site pilot program in the statea move thats prompted widespread criticism from the harm reduction community.

San Francisco officials have since signaled thattheyre prepared to defy the governorand launch an overdose prevention program regardless of the veto.

In another disappointment for reform advocates, a separate bill that would have legalized possession of limited amounts of certain psychedelics was recentlypulled by the sponsor after its main provisions were gutted, leaving just a study component that advocates say is unnecessary given the existing body of scientific literature on the subject.

Heres an overview of other recent drug policy developments in California:

In July, California officialsawarded more than $1.7 million in grantshelp promote sustainable marijuana cultivation practices and assist growers with obtaining their annual licenses. A total of $6 million will be allotted through the program,which was first announced in August 2021and will remain open for applications through April 2023.

Regulators also recently announced that they are soliciting input onproposed rules to standardize cannabis testing methodsin the statean effort that they hope will stop marijuana businesses from laboratory shopping to find facilities that are more likely to show higher THC concentrations that they can then boast for their products.

California hastaken in nearly $4 billion in marijuana tax revenuesince the states adult-use market launched in 2018, the Department of Tax and Fee Administration (CDTFA) reported in July. And for the first quarter of 2022, the state saw about $294 million in cannabis revenue generated from the excise, cultivation and sales tax on marijuana.

The state collected about$817 million in adult-use marijuana tax revenueduring the last fiscal year. That represented 55 percent more cannabis earnings for state coffers than was generated in the 2020-2021 period.

Three In Four Maryland Voters Support Marijuana Legalization Referendum, Including Majority Of Republicans, Poll Finds

Photo courtesy of Brian Shamblen.

Original post:
California Funds Research On Blocking Marijuana Monopolies And Protecting 'Legacy' Cannabis Strains - Marijuana Moment

NEW YORK, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Sema4 Holdings Corp. (NASDAQ: SMFR, SMFRW), Medtronic PLC (NYSE: MDT), Palantir Technologies, Inc. (NYSE: PLTR), and Fulgent Genetics, Inc. (NASDAQ: FLGT). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

Sema4 Holdings Corp. (NASDAQ: SMFR, SMFRW)

Class Period: March 14, 2022 August 15, 2022

Lead Plaintiff Deadline: November 7, 2022

On August 15, 2022, after the market closed, Sema4 announced changes to its research and development leadership team, including that Defendant Schadt was stepping down from his roles as President and Chief R&D Officer. The Company also disclosed that it was eliminating approximately 13% of its workforce as part of a series of restructuring and corporate realignments. During the related conference call, Sema4 revealed that it had reversed $30.1 million of revenue this quarter related to prior periods, in connection with negotiations with one of [Sema4s] larger commercial payors regarding the potential recoupment of payments for Sema4 carrier screening services rendered from 2018 to early 2022.

On this news, Sema4s stock fell $0.80, or 33.3%, to close at $1.60 per share on August 16, 2022, on unusually heavy trading volume.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that there was a significant risk that Sema4 would reverse a material amount of previously recognized revenue that it could not recoup from third party payors; (2) that the Company was experiencing declining selling prices for its reproductive health segment; (3) that, as a result of the foregoing, Sema4s financial results would be adversely affected; and (4) that, as a result of the foregoing, Defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Sema4 class action go to: https://bespc.com/cases/SMFR

Medtronic PLC (NYSE: MDT)

Class Period: June 8, 2019 May 25, 2022

Lead Plaintiff Deadline: November 7, 2022

Medtronic is a medical device company. Among its products is the MiniMed insulin pump system for the treatment of diabetes. The systems include the MiniMed 600 series models and the MiniMed 780G model. Medtronic is currently seeking regulatory approval for the MiniMed 780G model, which uses an advanced hybrid closed loop system. During the Class Period, Medtronic repeatedly assured investors that the MiniMed 780G model was on track for approval by the U.S. Food and Drug Administration (FDA) and would provide Medtronic with the edge it needed to close a growing gap with its competitors in the diabetes market.

Medtronic made these representations despite known issues with the MiniMed 600 series models. Indeed, in November 2019, the company issued a warning that certain MiniMed 600 series insulin pumps might have damaged pump retainer rings, which could cause the system to release too much insulin, and instructed customers with damaged rings to contact the company for replacements. On February 7, 2020, the FDA classified Medtronics November 2019 notification as a Class I recallthe most serious type of recall.

Problems with the MiniMed 600 series mushroomed in October 2021, when the company expanded its recall to all MiniMed model 630G and 670G insulin pump systemswhether or not any retainer ring damage was actually visible. Despite these serious issues with the 600 series, Medtronic assured investors that they expected the MiniMed 780G to drive growth. Consistent with these optimistic statements, Medtronic again assured investors that FDA approval of the MiniMed 780G was imminent.

Investors began to learn the truth about the companys MiniMed operations on December 15, 2021, when Medtronic revealed that it had received a warning letter from the FDA regarding its Northridge, California facility (the Warning Letter). The Warning Letter followed an FDA inspection relating to the companys MiniMed 600 series recall, and focused on the inadequacy of specific medical device quality system requirements . . . in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.

As a result of the Warning Letterincluding the resulting uncertainty about FDA approval of the MiniMed 780G and other products in Medtronics diabetes operating unit, the Diabetes Group, Medtronic lowered its guidance for its Diabetes Group, now projecting that Diabetes Group product revenues would decline in the mid-single digit range for fiscal year 2022. On this news, the price of Medtronic common stock declined $6.75 per share, or approximately 6%, from a close of $111.69 per share on December 14, 2021, to close at $104.94 per share on December 15, 2021.

The financial fallout from the FDAs findings continued to surface on May 26, 2022, when Medtronic reported its financial results for the fourth quarter and full fiscal year 2022, and provided guidance for fiscal year 2023. Notably, Medtronic disclosed that as a result of the companys need to improve its quality control system and its expectation that the MiniMed 780G modelwhich Defendants had repeatedly identified as crucial to future growthwould not be approved in 2023, the company expected revenues from its Diabetes Group to decline between 6% and 7% in fiscal year 2023. On this news, the price of Medtronic common stock fell $6.10 per share, or nearly 6%, from a close of $105.54 per share on May 25, 2022, to close at $99.44 per share on May 26, 2022.

Throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts, about the companys business and operations by failing to disclose that: (1) Medtronics product quality control systems were inadequate; (2) Medtronic had failed to comply with numerous regulations regarding risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events; (3) these failures increased the risk of regulatory investigation and action; (4) as a result of the companys misconduct, the FDA would delay the approval of additional Medtronic MiniMed devices, including the MiniMed 780G; (5) these delays in product approvals, as well as the companys need to improve its quality control systems, would negatively affect Medtronics financial performance and cause it to fall further behind its competitors; and (6) as a result of the foregoing, Defendants statements about the companys business, operations, and prospects lacked a reasonable basis.

For more information on the Medtronic class action go to: https://bespc.com/cases/MDT

Palantir Technologies, Inc. (NYSE: PLTR)

Class Period: November 9, 2021 May 6, 2022

Lead Plaintiff Deadline: November 14, 2022

Palantir builds and deploys software platforms to assist the U.S. intelligence community in counterterrorism investigations and operations. The Company has two operating segments, commercial and government,with the latter primarily serving agencies in the U.S. federal government and non-U.S. governments. Palantir also invests in so-called marketable securities consisting of equity securities in publicly-traded companies.

Palantir has consistently described sources of geopolitical instability and other disruptions e.g., armed conflicts, economic crises, and the COVID-19 pandemicas tailwinds for its business, given that the Companys products and services are purportedly built to aid its customers in assessing and responding to such disruptions.

On May 9, 2022, Palantir issued a press release announcing its Q1 financial results and guidance for Q2. For Q1, Palantir announced adjusted EPS of $0.02, compared to analyst estimates of $0.04 per share, noting on a conference call that the [f]irst quarter adjusted [EPS of] $0.02 . . . includes a negative $0.02 impact driven primarily by unrealized losses on marketable securities. The Company also disclosed that government revenue grew by only 16% year-over-year for Q1, representing a significant slowdown in revenue growth compared to prior quarters, and that, for Q2, the Company expected $470 million in sales, compared to estimates of $483.76 million.

On this news, Palantirs stock price fell $2.02 per share, or 21.31%, to close at $7.46 per share on May 9, 2022.

As multiple news outlets reported that day, Palantirs significant decline in revenue growth, particularly from its government customers, surprised investors, especially given the ongoing geopolitical instability and other disruptions caused by, inter alia, the ongoing COVID-19 pandemic and Russo-Ukrainian Warthat is, precisely the type of destabilizing conditions that the Company had previously touted as tailwinds for its business.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Palantirs investments in marketable securities were having a significant negative impact on the Companys earnings per share (EPS) results; (ii) Palantir overstated the sustainability of its government segments growth and revenues; (iii) Palantir was experiencing a significant slowdown in revenue growth, particularly among its government customers, despite ongoing global conflicts and market disruptions; (iv) as a result of all the foregoing, the Company was likely to miss consensus estimates for its first quarter 2022 (Q1) EPS and second quarter 2022 (Q2) sales outlook; and (v) as a result, the Companys public statements were materially false and misleading at all relevant times.

For more information on the Palantir class action go to: https://bespc.com/cases/PLTR

Fulgent Genetics, Inc. (NASDAQ: FLGT)

Class Period: March 22, 2019 August 4, 2022

Lead Plaintiff Deadline: November 21, 2022

Fulgent, together with its subsidiaries, provides COVID-19, molecular diagnostic, and genetic testing services to physicians and patients in the United States and internationally. As a result, Fulgent must comply with the federal Anti-Kickback Statute, which prohibits the knowing and willful payment of remuneration to induce or reward patient referrals or the generation of business involving any item or service payable by the Federal health care programs, as well as the federal Stark Law, which prohibits a physician from making referrals for certain designated health services, including laboratory services, that are covered by the Medicare program, to an entity with which the physician or an immediate family member has a direct or indirect financial relationship.

On August 4, 2022, Fulgent released its second quarter 2022 financial results, disclosing, among other items, that the US Securities and Exchange Commission (SEC) was conducting an investigation into certain of the Companys reports filed with the SEC from 2018 through the first quarter of 2020. The disclosure followed the Companys receipt of a civil investigative demand issued by the U.S. Department of Justice related to its investigation of allegations of medically unnecessary laboratory testing, improper billing for laboratory testing, and remuneration received or provided in violation of the Anti-Kickback Statute and the Stark Law.

On this news, Fulgents stock price fell $11.02 per share, or 17.29%, over the following two trading sessions, to close at $52.72 per share on August 8, 2022.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Fulgent had been conducting medically unnecessary laboratory testing, engaging in improper billing practices in relation to laboratory testing, and providing or receiving remuneration in violation of the Anti-Kickback Statute and Stark Law; (ii) accordingly, Fulgent was likely to become subject to enhanced legal and regulatory scrutiny; (iii) Fulgents revenues, to the extent they were derived from the foregoing unlawful conduct, were unsustainable; (iv) the foregoing, once revealed, was likely to subject the Company to significant financial and/or reputational harm; and (v) as a result, the Companys public statements were materially false and misleading at all relevant times.

For more information on the Fulgent class action go to: https://bespc.com/cases/FLGT

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit http://www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:

Bragar Eagel & Squire, P.C.

Brandon Walker, Esq.

Melissa Fortunato, Esq.

(212) 355-4648

investigations@bespc.com

http://www.bespc.com

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Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed ... - The Bakersfield Californian

By Kate Cook, Catherine M. Cook Group, LLC

In the past two years, the pandemic has kept sponsors developing drugs, biological products, and medical devices from meeting in person with FDA.Advisory committee meetings, workshops, and conferences have gone virtual, too. While some sponsors have hopes that changing pandemic conditions will open the doors to in-person meetings, this seems unlikely.

In-person meetings with FDA officials are likely to remain the rare exception, not the norm.The FDA commitment letter developed in the latest round of prescription drug user fee negotiations sets out FDAs commitments to meet face to face with the sponsor at specified stages in a product development program, but defines face-to-face to include... both in-person meetings and virtual meetings on IT platforms that allow for both audio and visual communication.

This means that FDA can opt to meet virtually instead of in person, and it has strong reasons to do so. Meeting virtually avoids the administrative work needed to bring outsiders onto the secure FDA campus, and the format more easily accommodates individual employee schedules.There are very clear scheduling advantages to virtual advisory committee meetings, which are easier to schedule when busy experts are not required to spend a half day or more traveling to and from an in-person meeting.

Moreover, it can seem impossible to bring FDA meeting participants together in one conference room. FDA staff are increasingly likely to be working remotely at locations nowhere near the FDAs White Oak campus in Maryland. FDA officials have made recent statements about the value in authorizing remote work as a recruitment tool, and it is a tool FDA is likely to be using.

FDA has a lot of recruiting to do.In the latest round of user fee agreements, the agency committed to significant numbers of targeted hires to support the prescription drug user fee program, including, for Fiscal Year 2023, 132 CBER staffers and 77 CDER staffers.Recruiting qualified scientific employees is always a challenge for FDA, but it will also need to address recent staff departures.Exhausted by the work of developing and supporting the FDAs pandemic response, experienced staff members are retiring or seeking outside employment in significant numbers.This exacerbates existing understaffing and can lead to significant losses of expertise and institutional memory.

Once these hundreds of new employees are hired, FDA will have to develop employees who work remotely and do not have the benefit of daily in-person interactions with their managers and mentors who may also be working remotely. This will present management and supervisory challenges for the agency and may change its work culture significantly. One thing for sponsors to look out for is that new reviewers sometimes default to an overly conservative position. Sometimes, it may be necessary for sponsors to ensure that supervisors are involved in giving FDA advice, particularly on novel issues.

The primary mechanism for sponsors to obtain advice from FDA on their development programs is by filing a request for a meeting. When FDA grants the meeting, it may be a face-to-face meeting (defined to include a virtual meeting), a teleconference, or a written response only. FDA and industry have described different meeting types in user fee commitment letters for prescription drugs and biological products (PDUFA), biosimilars (BsUFA), generic drugs (GDUFA), and medical devices (MDUFA) as well as in related guidance documents addressing meetings under PDUFA, BsUFA, GDUFA, and MDUFA.

These guidance documents are likely to be revised to incorporate new user fee commitments under the recently concluded negotiations, once Congress has enacted the legislation necessary to reauthorize these user fee programs. For example, the new PDUFA commitment letter addresses two types of meetings for the first time: INTERACT meetings and Type D meetings. An INTERACT meeting provides an opportunity for sponsors to discuss novel questions and unique challenges in early development, prior to filing an IND.A Type D meeting is focused on a narrow set of issues (typically not more than two issues and associated questions). Requests could include a follow-up question that raises a new issue after a formal meeting, a narrow issue on which the sponsor is seeking agency input with only a few associated questions, or a general question about an innovative development approach that does not require extensive, detailed advice.

FDAs commitment letters and guidance documents describe the criteria the sponsor must meet to be granted a specific type of meeting. Although FDAs user fee commitments recognize a right to a face-to-face meeting at certain stages in a product development program, under other circumstances FDA may decline to schedule a face-to-face meeting and will provide a written response only.The commitment letters and guidance documents address the timeframes for the sponsor to submit their briefing document and for FDA to respond to requests and to schedule meetings.

FDA has committed to send preliminary written responses to a sponsors questions contained in their background package.When a meeting has been scheduled, FDA will send the response in advance of the meeting, giving the sponsor the opportunity to focus the meeting on discussing certain FDA responses, or even to determine that the written response is adequate and a meeting is no longer necessary.

Some sponsors want to initiate meetings with FDA as early in development as possible. FDA has recognized that emerging technologies raising cross-cutting issues may warrant very early discussion and has created forums for such discussions in the Critical Path Innovation Meeting, CDERs Emerging Technology Team Meeting, and the CBER Advanced Technology Team Meeting. However, a sponsor that obtains advice too early in preclinical development of a specific product may find that significant pre-IND questions arise a short time after a pre-IND meeting because they decided to modify the product in important ways.Since FDA generally limits a sponsor to one pre-IND meeting, the sponsor may have to ask for advice on their new questions using a different meeting request format, such as a Type C meeting, which has longer timelines for agency response, or the new Type D meeting if FDA agrees that the scope is narrow enough for such a meeting.FDA has advised that for products regulated by CBERs Office of Tissues and Advanced Therapies (responsible for regulating cell and gene therapies, among other biological products), a pre-IND meeting is appropriate if:

A sponsor should assure that all sponsor attendees can access the video conference platform successfully, and that audio is clear and bug-free.The sponsors meeting plans should address not only who is responsible for the sponsors presentation, but also who is the critical note taker and who is authorized to call for a short internal conference if needed during the meeting.The sponsor should be able to mute the sound to FDA in case there is a need to hold a sidebar with sponsor attendees only.

If possible, all sponsor attendees should assemble at the same location.This can be challenging, given that sponsor employees often work at different locations and that a sponsors external consultants may be in attendance, but having everyone in the same room can allow a sponsor to adjust strategy in real time after an internal sidebar discussion.If it is necessary for sponsor representatives to participate from multiple locations, participants should have a plan in place to address the problems that can occur when one site loses connectivity.This may include identifying and preparing back-up presenters for critical presentations.

In addition, the sponsor should think about how their representatives are likely to present themselves to FDA and be on the lookout for presenters who may come across as dismissive of FDA questions and concerns.

A sponsors briefing book should make its case in support of the sponsors position on the issues they are asking FDA to advise on. This is especially important for a sponsor seeking FDA support for an innovative or less burdensome approach.If specific subject matter expertise is important to understanding the issues, a sponsor should request the participation of specific FDA employees or representatives of specific offices.For example, if an issue requires CMC or other manufacturing expertise, the sponsor may request the involvement of a representative from CDERs Office of Pharmaceutical Quality or CBERs Office of Compliance and Biologics Quality.

A sponsors primary point of contact with FDA is the project manager assigned to the development program.Sponsors regulatory affairs personnel generally understand the value of a good relationship with the project manager, who can sometimes work magic in facilitating informal communications between the sponsor and regulators.

FDAs written response to a briefing package may identify issues of concern to FDA.The sponsor should take every opportunity to probe the scope and significance of these concerns in the meeting and in future product development discussions.It sometimes happens that FDA raises an issue in early correspondence with a sponsor whose application for approval, filed years later, is not successful due to the same issue raised in early communications. Sometimes the early notice has prepared the sponsor for this possibility, and the sponsor is ready to make its case for approval on appeal or has already initiated studies to develop data to satisfy FDAs concern.However, sometimes the sponsor will have discounted the significance of FDAs early comments and is unprepared to address them.

A sponsor should also pay attention to the FDA staff attending the meeting.If you are unfamiliar with someone and their FDA role, do a little research.You may learn from an attendees slide presentations that they specialize in a specific issue, such as the distribution of a drug under a Risk Evaluation and Mitigation Strategy (REMS) program.This may signal that the parameters of a REMS distribution program for your drug are the subject of discussion within FDA. Similarly, the involvement of other individuals or offices may signal that FDA is focusing on a drug exclusivity or other type of issue.

Conclusion

The processes for using meeting requests to interact with FDA may seem overly formal, but a sponsor who follows them carefully, submits high-quality briefing materials, and maximizes their meeting opportunities will maximize their chances of receiving high-quality agency feedback. In addition to the assigned reviewers, a sponsors briefing book will also be read by FDA supervisors, whose supervisory and oversight roles may become more important and more challenging as they are called upon to train, mentor, and develop remote workers.

About The Author:

Kate Cook is an FDA veteran who has worked in legal and policy positions in the Office of Chief Counsel, as well as in the FDA's CBER and CDRH, where she served as associate director for regulations and policy.For more than 20 years, she was involved in every aspect of policy development, authoring or reviewing many regulations and guidances. Since she left the agency in 2016, she has worked as a regulatory attorney and consultant, helping her clients in their interactions with the FDAs medical product centers and on appeals to the Office of Commissioner. Cook graduated from Swarthmore College and the New York University School of Law, and was a New York County Assistant District Attorney and an attorney in private practice before joining the FDA. She founded the Catherine M. Cook Group, LLC, in 2022, and can be reached at Kate.Cook@CatherineMCook.com.

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Tips For Your Virtual Meetings With The FDA - Med Device Online

LONDONandNEW YORK, Oct. 04, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc(Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company will exhibit 15 poster presentations at the European Society of Gene and Cell Therapy (ESGCT) 2022 Annual Congress, which will be held from October 11-14, 2022, in Edinburgh, Scotland.

The posters will include data from MeiraGTxs novel gene regulation platform, including the first data demonstrating the potential to regulate CAR-T, as well as data from the Companys promoter platforms and several new, optimized pre-clinical programs addressing severe unmet needs for indications such as amyotrophic lateral sclerosis (ALS) and Wilsons disease. In addition, the Company will have presentations on its proprietary viral vector manufacturing technology and potency assay development.

Were pleased to present data illustrating the depth and versatility of MeiraGTxs scientific platforms, said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. The 15 published abstracts at this years ESGCT Congress reflect the extraordinary productivity of our research efforts in developing new technologies and applying them to the design of optimized genetic medicines, as well as innovation in manufacturing and process development technology. I am particularly excited for us to present our riboswitch gene regulation technology applied to cell therapy for the first time, in this case the regulation of CAR-Ts, which is a huge area of scientific and clinical interest, continued Dr. Forbes. We look forward to presenting these data highlighting our innovative platform technologies and broad R&D capabilities.

Abstract Title (P101): AI-driven promoter optimization at MeiraGTxSession Title: Advances in viral and non-viral vector designDate: October 12, 2022

Abstract Title (P124): Promoter Engineering Platform at MeiraGTxSession Title: Advances in viral and non-viral vector designDate: October 13, 2022

Abstract Title (P243): UPF1 delivered by novel expression-enhanced promoters protects cultured neurons in a genetic ALS modelSession Title: CNS and sensoryDate: October 12, 2022

Abstract Title (P254): Optimization and scale-up of AAV2-AQP1 production using a novel transient transfection agentSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P264): Designing and screening formulations to improve manufacturability and distribution of AAV gene therapiesSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P270): Use of anion exchange chromatography to provide high empty AAV capsid removal and product yieldsSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P320): Multivariate analysis for increased understanding of MeiraGTx upstream processSession Title: Developments in manufacturing and scale upDate: October 13, 2022

Abstract Title (P362): Development of AAV-UPF1 gene therapy to rescue ALS pathophysiology using microfluidic platformsSession Title: Disease models (iPS derived and organoids)Date: October 13, 2022

Abstract Title (P399): Titratable and reversible control of CAR-T cell receptor and activity by riboswitch via oral small moleculeSession Title: Engineered T and NK CARs and beyondDate: October 12, 2022

Abstract Title (P436): Novel riboswitches regulate AAV-delivered transgene expression in mammals via oral small molecule inducersSession Title: Gene and epigenetic editingDate: October 13, 2022

Abstract Title (P553): Development of optimized ATP7B gene therapy vectors for the treatment of Wilsons Disease with increased potencySession Title: Metabolic diseasesDate: October 12, 2022

Abstract Title (P554): A CNS-targeted gene therapy for the treatment of obesitySession Title: Metabolic diseasesDate: October 13, 2022

Abstract Title (561): Riboswitch-controlled delivery of therapeutic hormones for gene therapySession Title: Metabolic diseasesDate: October 12, 2022

Abstract Title (P622): Riboswitch-controlled delivery of therapeutic antibodies for gene therapySession Title: OtherDate: October 13, 2022

Abstract Title (P630): Improving AAV in vitro transducibility for cell-based potency assay developmentSession Title: OtherDate: October 13, 2022

About MeiraGTxMeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, and a transformative gene regulation platform technology which allows tight, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring, and developing technologies that give depth across both product candidates and indications. MeiraGTxs initial focus is on three distinct areas of unmet medical need: ocular, including inherited retinal diseases and large degenerative ocular diseases, neurodegenerative diseases, and severe forms of xerostomia. Though initially focusing on the eye, central nervous system, and salivary gland, MeiraGTx plans to expand its focus to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

For more information, please visit http://www.meiragtx.com.

Forward Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and our pre-clinical data and reporting of such data and the timing of results of data, including in light of the COVID-19 pandemic, as well as statements that include the words expect, will, intend, plan, believe, project, forecast, estimate, may, could, should, would, continue, anticipate and similar statements of a future or forward-looking nature. These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SECs website at http://www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts

Investors:MeiraGTxInvestors@meiragtx.com

Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com

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MeiraGTx Announces the Upcoming Presentation of 15 Abstracts at the European Society of Gene and Cell Therapy (ESGCT) 2022 Annual Congress -...

Grande, I., Berk, M., Birmaher, B. & Vieta, E. Bipolar disorder. Lancet 387, 15611572. https://doi.org/10.1016/S0140-6736(15)00241-X (2016).

PubMed Google Scholar

Laursen, T. M., Munk-Olsen, T., Nordentoft, M. & Mortensen, P. B. Increased mortality among patients admitted with major psychiatric disorders: A register-based study comparing mortality in unipolar depressive disorder, bipolar affective disorder, schizoaffective disorder, and schizophrenia. J. Clin. Psychiatry 68, 899907. https://doi.org/10.4088/jcp.v68n0612 (2007).

PubMed Google Scholar

Osby, U., Brandt, L., Correia, N., Ekbom, A. & Sparen, P. Excess mortality in bipolar and unipolar disorder in Sweden. Arch. Gen. Psychiatry 58, 844850. https://doi.org/10.1001/archpsyc.58.9.844 (2001).

CAS PubMed Google Scholar

Hsu, J. H., Chien, I. C. & Lin, C. H. Increased risk of ischemic heart disease in patients with bipolar disorder: A population-based study. J. Affect. Disord. 281, 721726. https://doi.org/10.1016/j.jad.2020.11.083 (2021).

PubMed Google Scholar

Wu, S. I. et al. Relative risk of acute myocardial infarction in people with schizophrenia and bipolar disorder: A population-based cohort study. PLoS ONE 10, e0134763. https://doi.org/10.1371/journal.pone.0134763 (2015).

CAS PubMed PubMed Central Google Scholar

Osby, U., Westman, J., Hallgren, J. & Gissler, M. Mortality trends in cardiovascular causes in schizophrenia, bipolar and unipolar mood disorder in Sweden 19872010. Eur. J. Public Health 26, 867871. https://doi.org/10.1093/eurpub/ckv245 (2016).

PubMed PubMed Central Google Scholar

Laursen, T. M., Mortensen, P. B., MacCabe, J. H., Cohen, D. & Gasse, C. Cardiovascular drug use and mortality in patients with schizophrenia or bipolar disorder: A Danish population-based study. Psychol. Med. 44, 16251637. https://doi.org/10.1017/S003329171300216X (2014).

CAS PubMed Google Scholar

Crump, C., Sundquist, K., Winkleby, M. A. & Sundquist, J. Comorbidities and mortality in bipolar disorder: A Swedish national cohort study. JAMA Psychiat. 70, 931939. https://doi.org/10.1001/jamapsychiatry.2013.1394 (2013).

Google Scholar

Cubbin, C. et al. Neighborhood deprivation and cardiovascular disease risk factors: Protective and harmful effects. Scand. J. Public Health 34, 228237 (2006).

PubMed Google Scholar

Hotchkiss, J. W. et al. Trends in adult cardiovascular disease risk factors and their socio-economic patterning in the Scottish population 19952008: Cross-sectional surveys. BMJ Open 1, e000176. https://doi.org/10.1136/bmjopen-2011-000176 (2011).

PubMed PubMed Central Google Scholar

Diez Roux, A. V. et al. Neighborhood of residence and incidence of coronary heart disease. N. Engl. J. Med. 345, 99106. https://doi.org/10.1056/NEJM200107123450205 (2001).

CAS PubMed Google Scholar

Sundquist, K., Malmstrom, M. & Johansson, S. E. Neighbourhood deprivation and incidence of coronary heart disease: A multilevel study of 26 million women and men in Sweden. J. Epidemiol. Community Health 58, 7177. https://doi.org/10.1136/jech.58.1.71 (2004).

CAS PubMed PubMed Central Google Scholar

Kirkbride, J. B., Jones, P. B., Ullrich, S. & Coid, J. W. Social deprivation, inequality, and the neighborhood-level incidence of psychotic syndromes in East London. Schizophr. Bull. 40, 169180. https://doi.org/10.1093/schbul/sbs151 (2014).

PubMed Google Scholar

Walsan, R. et al. Serious mental illness, neighborhood disadvantage, and type 2 diabetes risk: A systematic review of the literature. J. Prim. Care Community Health 9, 2150132718802025. https://doi.org/10.1177/2150132718802025 (2018).

PubMed PubMed Central Google Scholar

Sundquist, J., Johansson, S. E., Yang, M. & Sundquist, K. Low linking social capital as a predictor of coronary heart disease in Sweden: A cohort study of 28 million people. Soc. Sci. Med. 62, 954963 (2006).

PubMed Google Scholar

Sundquist, J., Li, X. & Sundquist, K. Neighborhood deprivation and mortality in individuals with cancer: A multilevel analysis from Sweden. Eur. J. Cancer Prev. 21, 387394. https://doi.org/10.1097/CEJ.0b013e32834dbc2e (2012).

PubMed Google Scholar

Sundquist, J., Malmstrom, M. & Johansson, S. E. Cardiovascular risk factors and the neighbourhood environment: A multilevel analysis. Int. J. Epidemiol. 28, 841845 (1999).

CAS PubMed Google Scholar

Winkleby, M., Sundquist, K. & Cubbin, C. Inequities in CHD incidence and case fatality by neighborhood deprivation. Am. J. Prev. Med. 32, 97106 (2007).

PubMed PubMed Central Google Scholar

Li, X., Sundquist, J., Forsberg, P. O. & Sundquist, K. Association between neighborhood deprivation and heart failure among patients with diabetes mellitus: A 10-year follow-up study in Sweden. J. Card. Fail. 26, 193199. https://doi.org/10.1016/j.cardfail.2019.04.017 (2020).

PubMed Google Scholar

Calling, S., Li, X., Kawakami, N., Hamano, T. & Sundquist, K. Impact of neighborhood resources on cardiovascular disease: A nationwide six-year follow-up. BMC Public Health 16, 634. https://doi.org/10.1186/s12889-016-3293-5 (2016).

PubMed PubMed Central Google Scholar

Gilthorpe, M. S. The importance of normalisation in the construction of deprivation indices. J. Epidemiol. Community Health 49(Suppl 2), S45S50 (1995).

PubMed PubMed Central Google Scholar

Zhou, Y. et al. Coronary heart disease and depression or anxiety: A bibliometric analysis. Front. Psychol. 12, 669000. https://doi.org/10.3389/fpsyg.2021.669000 (2021).

PubMed PubMed Central Google Scholar

Strachan, E., Duncan, G., Horn, E. & Turkheimer, E. Neighborhood deprivation and depression in adult twins: genetics and genexenvironment interaction. Psychol. Med. 47, 627638. https://doi.org/10.1017/S0033291716002622 (2017).

CAS PubMed Google Scholar

Raphael, E. et al. Neighborhood deprivation and mental health among immigrants to Sweden. Epidemiology 31, e25e27. https://doi.org/10.1097/EDE.0000000000001160 (2020).

PubMed PubMed Central Google Scholar

Rothman, K. J., Greenland, S. & Lash, T. Modern Epidemiology Vol. 3 (Lippincott Williams & Wilkins, 2008).

Google Scholar

Lau, B., Cole, S. R. & Gange, S. J. Competing risk regression models for epidemiologic data. Am. J. Epidemiol. 170, 244256. https://doi.org/10.1093/aje/kwp107 (2009).

PubMed PubMed Central Google Scholar

Tully, A. et al. Interventions for the management of obesity in people with bipolar disorder. Cochrane Database Syst. Rev. 7, 013006. https://doi.org/10.1002/14651858.CD013006.pub2 (2020).

Google Scholar

Bora, E., McIntyre, R. S. & Ozerdem, A. Neurococognitive and neuroimaging correlates of obesity and components of metabolic syndrome in bipolar disorder: A systematic review. Psychol. Med. 49, 738749. https://doi.org/10.1017/S0033291718003008 (2019).

PubMed Google Scholar

Kendall, T. et al. Assessment and management of bipolar disorder: Summary of updated NICE guidance. BMJ 349, g5673. https://doi.org/10.1136/bmj.g5673 (2014).

CAS PubMed Google Scholar

Calkin, C. V., Gardner, D. M., Ransom, T. & Alda, M. The relationship between bipolar disorder and type 2 diabetes: More than just co-morbid disorders. Ann. Med. 45, 171181. https://doi.org/10.3109/07853890.2012.687835 (2013).

CAS PubMed Google Scholar

Kilbourne, A. M. et al. Nutrition and exercise behavior among patients with bipolar disorder. Bipolar Disord. 9, 443452. https://doi.org/10.1111/j.1399-5618.2007.00386.x (2007).

PubMed Google Scholar

Kessing, L. V., Ziersen, S. C., Andersen, P. K. & Vinberg, M. A nation-wide population-based longitudinal study mapping physical diseases in patients with bipolar disorder and their siblings. J. Affect. Disord. 282, 1825. https://doi.org/10.1016/j.jad.2020.12.072 (2021).

PubMed Google Scholar

Lasser, K. et al. Smoking and mental illness: A population-based prevalence study. JAMA 284, 26062610. https://doi.org/10.1001/jama.284.20.2606 (2000).

CAS PubMed Google Scholar

Aslanyan, S., Weir, C. J., Lees, K. R., Reid, J. L. & McInnes, G. T. Effect of area-based deprivation on the severity, subtype, and outcome of ischemic stroke. Stroke 34, 26232628. https://doi.org/10.1161/01.STR.0000097610.12803.D7 (2003).

PubMed Google Scholar

Zoller, B., Li, X., Sundquist, J. & Sundquist, K. Neighborhood deprivation and hospitalization for venous thromboembolism in Sweden. J. Thromb. Thrombolysis 34, 374382. https://doi.org/10.1007/s11239-012-0728-4 (2012).

PubMed Google Scholar

The, L. Syndemics: Health in context. Lancet 389, 881. https://doi.org/10.1016/S0140-6736(17)30640-2 (2017).

Google Scholar

Skoog, J., Midlov, P., Beckman, A., Sundquist, J. & Halling, A. Drugs prescribed by general practitioners according to age, gender and socioeconomic status after adjustment for multimorbidity level. BMC Fam. Pract. 15, 183. https://doi.org/10.1186/s12875-014-0183-8 (2014).

PubMed PubMed Central Google Scholar

Crump, C., Sundquist, K., Sundquist, J. & Winkleby, M. A. Neighborhood deprivation and psychiatric medication prescription: A Swedish national multilevel study. Ann. Epidemiol. 21, 231237. https://doi.org/10.1016/j.annepidem.2011.01.005 (2011).

PubMed PubMed Central Google Scholar

Sundquist, K. et al. Neighborhood violent crime and unemployment increase the risk of coronary heart disease: A multilevel study in an urban setting. Soc. Sci. Med. 62, 20612071. https://doi.org/10.1016/j.socscimed.2005.08.051 (2006).

PubMed Google Scholar

Derose, K. P. & Varda, D. M. Social capital and health care access: A systematic review. Med. Care Res. Rev. 66, 272306. https://doi.org/10.1177/1077558708330428 (2009).

PubMed PubMed Central Google Scholar

Akwo, E. A. et al. Neighborhood deprivation predicts heart failure risk in a low-income population of Blacks and Whites in the Southeastern United States. Circ. Cardiovasc. Qual. Outcomes 11, e004052. https://doi.org/10.1161/CIRCOUTCOMES.117.004052 (2018).

PubMed PubMed Central Google Scholar

Kawakami, N., Winkleby, M., Skog, L., Szulkin, R. & Sundquist, K. Differences in neighborhood accessibility to health-related resources: A nationwide comparison between deprived and affluent neighborhoods in Sweden. Health Place 17, 132139. https://doi.org/10.1016/j.healthplace.2010.09.005 (2011).

PubMed Google Scholar

Bikdeli, B. et al. Place of residence and outcomes of patients with heart failure: Analysis from the telemonitoring to improve heart failure outcomes trial. Circ. Cardiovasc. Qual. Outcomes 7, 749756. https://doi.org/10.1161/CIRCOUTCOMES.113.000911 (2014).

PubMed PubMed Central Google Scholar

Newcomer, J. W. Antipsychotic medications: metabolic and cardiovascular risk. J. Clin. Psychiatry 68(Suppl 4), 813 (2007).

PubMed Google Scholar

Bond Huie, S. The concept of neighbourhood in health and mortality research. Soc. Spectr. 21, 341358 (2001).

Google Scholar

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Neighborhood deprivation and coronary heart disease in patients with bipolar disorder | Scientific Reports - Nature.com

Duke Health leadership launched Translating Duke Health in 2017 as a multi-disciplinary, multi-year commitment to capitalize on Dukes collective strengths in research, clinical care, and population health to address major health challenges.

This article is the fourth of a series exploring how Translating Duke Health has changed the health care landscape at Duke. Learn more about Translating Duke Health.

Translating Duke Health: Controlling the Immune System

Pause for a moment, and take a deep breath.

Now, as you read this, your immune system is hard at work: analyzing the thousands of microbes you just inhaled and which now fill your respiratory tract and lungs. Sensor cells, one of your bodys first lines of defense, are searching for potentially dangerous pathogens, and split decisions are made whether to trigger a defense response toward any unwelcome visitors.

When functioning properly, the immune system maintains this delicate balance on a continuous basis, scanning for friend or foe and responding accordingly. Understanding how the system functions harmoniously with our environment and how we can harness its power to improve human health is one of the five pillars of the Translating Duke Health Initiative.

Under the leadership of Allan D. Kirk, MD, PhD, chair of the Department of Surgery, the immunology steering committee has successfully worked for five years to increase funding for discovery-based and translational immunology research at Duke, recruiting top scientists in the field to the institution to continue this important work.

Every disease is influenced by immunity, Kirk said. The immune system has evolved over millions of years to maintain homeostasis despite continuous threat, and those threats can come from the outside, microorganisms, or trauma, but also from the inside when cells that are normal transform into cancer cells, or when the immune system inappropriately recognizes our own cells as being foreign, such as in autoimmune-disease.

Tapping into this powerful and complex system has the potential to improve human health in myriad ways.

In late 2019, as the world started to hear whispers of an emerging virus in China, Priyamvada Acharya, PhD, associate professor in the Departments of Surgery and Biochemistry, was in the process of applying for a grant on human parainfluenza virus type 3 (HPIV-3).

Acharya came to Duke in 2019 as a result of Translating Duke Healths recruitment efforts. As an immunologist who had studied the human immunodeficiency virus (HIV) for most of her professional career, Acharya was interested in using the tools she had already learned and apply them to a new virus.

The timing of this decision, it turns out, was serendipitous.

I started looking at the structure of the HPIV-3 fusion (F) protein, and was intrigued by its large central cavity, Acharya said. It was a structure that was unique, in that it was full of empty. We started looking at other viral proteins with similar large internal cavities, and came across the spike protein of coronaviruses. Thats when we turned our attention to SARS-CoV-2 that was emerging in China at the time.

Because Acharya was already funded by an R01 grant from the National Institutes of Health (NIH), she was able to receive a supplement to expand her work into studying coronaviruses and SARS-CoV-2. Previous efforts by the Translating Duke Health initiative to fund immunology research at Duke made this rapid pivot in research scope possible.

In a sense, we were taking our first steps, because we had no idea of the biology of this new virus, Acharya said, so we thought we should do what we know. We knew proteins, so if we forgot all the biology, that perspective would not be that hard.

Over the next year, Acharya and her collaborating researchers would study the protein structures on the surface of SARS-CoV-2, eventually discovering that the virus spike proteins were mutating to create variants that made the virus more transmissible. In August 2021, Acharya and her team published this important research in Science.

I want to thank the Translating Duke Health initiative, Acharya said. The startup funding I received was key to getting other funding and to really dig into new science. It was key to have that support from the Duke Human Vaccine Institute.

Acharya continues to study the new SARS-CoV-2 variants as they emerge, including BA.5, to understand how they are able to evade the bodys immune system even if antibodies are present from the COVID-19 vaccine.

Now, in 2022 as infections continue, the importance of this research is exceedingly clear.

While the immune system fights its continuous battle, researchers like Acharya study the invaders: the bacteria, viruses, and pathogens that cause disease.

Other scientists, such as R. Keith Reeves, PhD, professor in the Departments of Surgery and Pathology, focus their attention on the other side of the battlefield: investigating the biology of human cells and how they respond to these outside threats.

Reeves was recruited to Duke from Harvard University in 2021, joining the newly created Center for Human Systems Immunology, which was founded to promote Translating Duke Health efforts. His research, supported by multiple R01 and P01 grants from the NIH, seeks to answer questions about the mechanisms and behavior of natural killer (NK) cells.

Unlike T and B immune cells, which adapt over time as they encounter pathogens, NK cells are generally considered part of the bodys innate immune response, attacking anything in the body that appears to be non-self. Reeves has made notable strides in helping the scientific community understand the important role that NK cells play in the immune system.

It was thought for a long time that NK cells could not mount an adaptive response, that they can't adapt to individual antigens, said Reeves. But actually, we were one of the labs that first described that NK cells could actually have adaptive memory functions.

This discovery has opened the door for further investigation on how NK cells can be used in cell-based therapies, a major component of Reeves current research.

We are currently conducting molecular, cell-based, and protein assays to determine the mechanisms of how NK cells could best recognize an HIV-infected cell, or how they could recognize an influenza-infected cell, Reeves said. Then going one step beyond that, we want to know what mechanisms they use to eliminate them, once the NK cells recognize a sick cell versus a healthy one.

With gene-editing technologies such as CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), Reeves says that NK cells could be modified and programmed to initiate a specific response. This process has the potential to create powerful cell-based immunotherapies.

Conversely, understanding the function of NK cells and how to suppress their immune response has other important applications, including in transplant research.

One of the reasons that our team came to Duke is that we are very interested in seeing where we could take our work and expertise and apply it to transplant studies, Reeves said. As good as NK cells can be for responding to infectious disease or cancer, they may actually complicate matters during organ transplant.

Reeves added that its important for research programs to study NK cells in reverse, learning how to dampen the immune response in order to achieve better outcomes.

Fortunately, Duke has a long history of investigative research in transplant immunology.

As a surgeon-scientist, fourth-year general surgery resident Brian Shaw, MD, has a unique perspective in the field of immunology. In the laboratory, he researches how immune cells specifically respond to organ transplant, how they change over time, and what treatments can be used to manipulate their response. In the operating room and clinic, he sees the direct impact of immunosuppressive therapies on patients post-transplant.

In spite of great advances in solid organ transplantation, we still have really poor outcomes for people with end-stage organ disease, Shaw said. In fact, successful kidney transplantation still only offers survival that is the same or worse as breast cancer with metastatic disease. Most of the morbidity and mortality associated with transplantation is due to imperfect immunosuppression.

Paraphrasing from Kirk, Shaw said that every immune response is a decision that has three components: specificity, context, and magnitude. Research has been able to successfully track the context in which the immune system activates and the magnitude of its response but the specificity of how the system works remains an unanswered question.

For patients who require immunosuppressive therapies, this gap in knowledge about the specific cells that respond to and injure a transplanted organ requires that the patients entire immune system be suppressed in order to prevent organ rejection.

As we know, immunosuppression is not benign, Shaw said. It has all sorts of negative side effects. Patients on chronic immunosuppression have two times the mortality rate from cancer as the general population.

As a potential solution, Shaws research tracks specific immune cells affected by transplant and how they can be manipulated to blunt their response to the new organ. Rather than lowering the overall level of activation of the immune system through immunosuppressive therapies, this research could reveal what therapies will specifically inhibit the cells which cause transplanted organs to fail.

Were fortunate to be at Duke, said Shaw, whose work is currently funded by an R38 grant to support clinician-scientists. This work requires very specialized instrumentation, and also specialized analysis. All the tools we're using utilize next-generation sequencing including single cell sequencing to analyze T cells and their specific receptors over time.

At Duke, an institution that recently completed its 10,000th organ transplant, Shaw says he is grateful to be in an environment that is able to help so many patients through transplant.

I think it shows you the impact that were having on people, Shaw said. Organ transplant is one of the few things that we do where the patients get better within a matter of days to weeks. Someone who needs a kidney transplant can sometimes be off dialysis the next day. If someone needs a liver transplant, they could be sick in an ICU on a ventilator, and within a week or two theyre walking out of the hospital to be with their families. It says something about our society, that weve been generous enough to donate these gifts to others.

Bettering outcomes for patients who receive improved immunotherapies, Shaw said, honors the gifts made by organ donors.

Acharya, Reeves, and Shaw are just three researchers among many at Duke who have been supported by the Translating Duke Health Initiative. Across the university, overlapping investigation contributes to our ability to unravel the mysteries of the immune system.

The understanding of how immunity can be harnessed as a tool to protect us better is the real focus of this initiative, Kirk said. The solution were seeking is to completely characterize and understand the signals used in that network so they can be harnessed, recognized, and mobilized as tools themselves.

With each scientific discovery, immunology researchers at Duke get closer to doing just that.

Scott Behm is Director of Communications for Duke Surgery

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Unraveling the Mysteries of the Immune System - Duke University School of Medicine

Social distancing has become part of everyday life for many people since the start of COVID-19. And yet many misconceptions exist about its impact on the immune system.

This is an effective tool in helping to limit disease spread, especially when paired with other public health measures. Knowing more about how social distancing may impact the immune system can help you in taking preventive measures to maintain emotional and physical health.

The terms social distancing and physical distancing have been used interchangeably since the beginning of COVID-19, but they do mean two slightly different things:

Most of the general public hadnt heard of social distancing prior to the COVID-19 pandemic much less practiced it when sick or not feeling well.

Many people think that the lack of exposure to germs due to social distancing weakens the immune system and makes us more vulnerable to infections and sickness. This is called the hygiene hypothesis.

While we do need exposure to germs to build a strong immune response, staying away from germs wont weaken our immunity. The body remembers exposure to germs, and the lack of exposure to germs that social distancing allows does not weaken our bodys memory.

That being said, reduced or minimal social interactions and personal connections with other people that are part of social distancing can have psychological and emotional effects. This may include depression and feelings of loneliness and isolation.

In turn, these can have negative effects on health and health behaviors, including being more sedentary, negative changes in diet, and increased blood pressure.

Depression can interfere with ones job, possibly leading to financial worries and further impacting ones physical and emotional health all of which negatively affects the immune system.

The World Health Organization (WHO) defines herd immunity as the indirect immunity or protection from a disease that occurs when much of the population becomes immune to the disease, either by vaccination or prior infection.

Social distancing does not go against the concept of herd immunity but instead works in tandem with it. Especially with a dangerous virus that can cause death or disability, allowing infection to spread just to achieve herd immunity is irresponsible.

Social distancing works with herd immunity because vaccines can be deployed to eligible individuals while social distancing measures are in place. This allows minimal contact among individuals while taking steps to mitigate the spread of infection.

It also helps to protect vulnerable populations and those who cannot be vaccinated at that time. Once a sizable amount of people are vaccinated, social distancing measures can be slowly and progressively relaxed.

During the COVID-19 pandemic, social distancing was found to be significantly effective and beneficial in reducing the spread of coronavirus.

This is because when people are closer in proximity to each other, airborne transmission of the virus via droplets occurs, but social and physical distancing helps to reduce the likelihood of that.

Its beneficial because if people adhere to it, especially along with other public health tactics like handwashing and mask-wearing, its a fairly easy way to reduce the likelihood of transmission.

Social distancing isnt just for pandemics! It can also help protect you against the flu, especially when used along with other precautions, such as:

This doesnt mean you need to lock yourself in your house all winter. But by taking these preventive measures, you can help to reduce the risk of flu.

Anyone can be impacted by social distancing, but older people may be especially sensitive to it. This may be for a variety of reasons, including chronic illness, loss of family or friends, and sensory impairments that can make things like Zoom or video calls more difficult.

Individuals who are already having a challenging time or those who may need an extra level of support can also be affected by social distancing. Factors that can make isolation more difficult include:

If people need help with everyday activities and theyre not able to get in-person assistance or support, this only has a further negative impact on physical and mental health.

Social distancing, especially prolonged social distancing, can also have significant impacts on children, adolescents, and young adults. According to a 2021 study, the impact on children was significant:

A 2022 study also found that social distancing caused elevated stress levels and lowered mood in adolescents. Teenagers need to spread their wings, explore their autonomy, and connect with peers, and social isolation during the pandemic hampered all of that. However, some things helped to minimize the negative effects. These included:

Explaining the reasons behind social distancing to children and teens, and recognizing that theyre experiencing stressors from the pandemic as well is important. Finding and encouraging healthy coping behaviors can help improve emotional and psychological health.

Social distancing became a commonly used term with the COVID-19 pandemic, referring to staying at home, minimizing social gatherings, and maintaining a distance of 6 feet between oneself and others in order to minimize the spread of disease.

While this is effective in helping to reduce the spread of disease, it can also have negative impacts on emotional and mental health.

Being aware of the stressors involved with social distancing, especially for children, teens, older adults, and those with pre-existing conditions, can help to minimize negative effects. Using positive coping skills can also help reduce those stressors.

Despite potential drawbacks to social distancing, it remains an effective tool in helping to control the spread of disease.

Originally posted here:
Social Distancing: The Impact on Your Health and Immune System - Healthline

SCOTTSDALE, Ariz. (PRWEB) October 06, 2022

VitaGaming.com is a Gaming Supplement Company focusing on healthy supplements for Gamers and the Gaming Lifestyle. VitaGamings proprietary line of supplements include brain health, focus and concentration and increased energy.

The highly competitive and strenuous demands of professional gaming are widely known to pose challenges on the immune system and overall wellbeing of e-sports athletes, who are constantly pushed to go beyond the limits of physical and mental endurance to achieve success. These days, however, its an absolute must for gamers -- and anyone with a similarly hectic lifestyle -- to be extra cautious in protecting themselves from the onslaught of different kinds of viruses and stress-related diseases.

Protection against viral infections

When the immune system works at peak level, it becomes our bodys first line of defense against outside invaders such as viruses, fungi, toxins, and bacteria. A healthy immune system defends the body against infectious diseases while protecting its own cells.

In fact, with its own unique intelligence, the immune system is known to keep a record of every single germ or microbe it has ever defeated, so that if ever the same intruder enters the body again, it can be detected and destroyed right away, before it multiplies and make you sick.

However, when the immune system is compromised, its protective properties are impaired and the body becomes susceptible to a variety of adverse conditions, including skin and respiratory allergies, asthma, autoimmune disorders, delayed wound healing, colds, and viral infections, among others.

With daily use of VitaGamings Immune Support, you can be sure that your hardworking immune system is nourished with the micronutrients that have been found to be most critical in maintaining healthy immune response: Vitamin C (ascorbic acid), Vitamin D3 (cholecalciferol), and Zinc.

On top of these vital ingredients, VitaGamings Immune Support also contains Quercetin -- whose powerful natural antioxidant and anti-inflammatory properties have been known to ease allergy symptoms, protect against cancer and degenerative brain disorders, reduce blood pressure, help control blood sugar, and even improve exercise performance. More recently, Quercetin has also received much attention from medical researchers for its potential value in the treatment and prevention of COVID-19.

Helping the body heal and regenerate

Meanwhile, VitaGamings Collagen is formulated to help the body heal and restore its natural suppleness, while at the same time, reduce the adverse impacts of stress and aging on the bones, joints, and skin.

Collagen supplementation has been found to provide a variety of health benefits that include younger-looking skin, relief from joint stiffness and pain, and building stronger bones, nails and hair. Some studies also indicate that collagen may help promote muscle growth after exercise.

Made from the finest herbal and botanical ingredients, VitaGaming products are formulated to enhance the competencies and overall wellness of pro gamers, athletes, and people with active lifestyles.

All our products are premium, natural supplements that are non-GMO, gluten-free, and caffeine-free, says VitaGaming founder, Jordan Totten. They are power-packed, complete, and are conveniently packaged in concentrated volumes that are hard to obtain through diet alone.

For more information on how you can achieve peak performance in e-sports or in your active lifestyle with VitaGamings all-natural premium supplements, check out http://www.vitagaming.com.

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VitaGaming Introduces Immune Support and Collagen to help Gamers boost immunity and fight stress - PR Web