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Archive for the ‘Legal Issues Genetic Medicine’ Category

Egg Donation Process: From Application to Recovery – Healthline

Tuesday, July 6th, 2021

There are a number of reasons you might consider donating your eggs. For some, the choice is monetary, as you may be well-compensated for your donation. For others, its the act of helping a couple have a baby. And it can certainly be both.

Whatever your motivation, the egg donation process is relatively straightforward and takes place over a 2-month period, according to the Center for Reproductive Health & Gynecology. Once you pass the initial application and legal hurdles, youll use medications to prepare your eggs for the egg procedure.

Keep reading to learn more about the egg donation process, including the possible risks and some tips for ways to prepare yourself before, during, and after the procedure.

Egg donation involves a donor who provides eggs to a recipient for the purpose of getting pregnant. Sometimes this recipient is the intended parent, and other times, it may be a surrogate who will carry a pregnancy for the intended parents.

A 2017 study showed that typically, between 5 to 24 eggs will be retrieved per cycle. The number of eggs retrieved is based on how many you produce and any specific guidelines the clinic follows.

Compensation for egg donation varies by area and fertility clinic. ConceiveAbilities, which has offices across the United States, shares that donor compensation begins at $8,000 per donation. This amount can go up based on various factors specific to each clinic.

The egg donor will receive various injectable medications throughout their menstrual cycle. These medications stimulate your ovaries to produce multiple eggs. Specific medications may include:

First, you will receive a dose of human chorionic gonadotropin (hCG), which is sometimes called a trigger shot. A doctor will remove the eggs in a procedure called egg retrieval. This is performed using a special needle attached to a transvaginal ultrasound device. The needle is passed through your vaginal wall and into your ovary. The eggs are suctioned (aspirated) out and sent to an embryologist for evaluation before fertilization.

Here is a step-by-step overview of the entire process:

Next, the eggs can either be frozen or mixed together with the intended fathers sperm to create embryos. The embryos are then transferred and implanted into the uterus of the birth parent or surrogate.

Yes. Egg donation when closely supervised by a medical professional is generally a safe process and does not carry any long-term health risks. This includes fertility issues, provided you dont develop complications.

A 2015 research review showed that most young adult females have around 400,000 eggs. So, taking even up to 24 eggs per donation cycle for several cycles will leave many to spare for the future.

However, there are some short-term risks to be aware of during the donation cycle. These risks include:

Its not easy to predict the discomfort you may experience before, during, and after the retrieval process. Many factors may contribute to pain, including your personal tolerance level, your bodys reaction to the different medications, as well as any complications you may experience.

Symptoms you may have after the egg retrieval include:

The good news is that you can expect your discomfort to improve as soon as the day or a few days after the retrieval procedure.

Your doctor will advise you about over-the-counter (OTC) medications you can take for pain, such as acetaminophen or ibuprofen. A heating pad may also help ease abdominal discomfort.

If you develop a fever, heavy bleeding, or any other symptoms of infection, call your doctor as soon as possible.

Preparing your body for egg donation is similar to preparing your body for the in vitro fertilization process. First, youll want to take good care of yourself by following a healthy lifestyle.

Fertility clinics, like the CNY Fertility Center, recommend paying special attention to the following areas for 3 months before retrieval for the best quality eggs:

Its also a good idea to create a support network for yourself. Egg donation can be challenging both physically and emotionally, so having trusted friends or family members nearby can help. Your support network can also help if you need transportation to and from appointments or any other assistance during the process.

Above all else: Ask questions. A 2020 survey of egg donors revealed that 55 percent of women did not feel they were well educated on the long-term risks of donation. Your doctor or fertility clinic can give you specific advice and resources to both understand and lower your risk of complications.

There are both state and federal regulations surrounding egg donation. Specifics vary depending on your state, so be sure to check with your clinic for any specific information that applies where you live.

Children born through egg donation are not considered your legal children, despite their genetic relation to you. The intended parent is listed as the guardian on any legal documents, like the birth certificate.

These details should be clearly stated in any contracts that you sign before the physical process begins. Working with lawyers to come up with an egg donation legal agreement can help protect you and ensure youll be fairly compensated.

Areas covered by the egg donation contract may include:

Be sure to ask yourself how much (if any) involvement you would want after your donation. Your rights are protected once you sign your agreement. And as the donor, you should have your own attorney. Tulip Fertility says that this does not come as a cost to you. Instead, the intended parents should cover these fees.

The egg donation process involves various physical, emotional, and potentially legal challenges. Along with doing your own research, reach out to a local fertility clinic for more specifics about your location and your personal situation.

Theres a lot to consider, but donating your eggs can be incredibly rewarding and financially empowering. Once you understand the risks and rewards, you can make the right choice for yourself and your future.

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Patent protection of mRNA vaccines and regulatory authorization – Lexology

Tuesday, July 6th, 2021

Researchers have been studying and working with mRNA vaccines for decades. Interest in these vaccines has grown since they can be developed in a laboratory using readily available materials for low-cost manufacture and safe administration. This means that the process can be standardized and scaled up, which make vaccine development faster than traditional methods of making vaccines.

As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.

For most emerging virus vaccines, the main obstacle is not the effectiveness of conventional approaches but the need for more rapid development and large-scale deployment.

How mRNA vaccines work

Messenger ribonucleic acid (mRNA) vaccines are a novel technology that stimulates the bodys own immune response. These vaccines contain information from mRNA, including the blueprint or code of a specific virus trait (virus antigen). The information enables the body to produce this antigen on its own: mRNA transfers the information for the production of the antigen to our cell machinery that makes proteins. Cells in our body then present the antigen on their surface and thus trigger the desired specific immune response. When the body comes into contact with the virus, the immune system recognizes the specific antigen and can fight the virus and thus the infection quickly and in a targeted manner.

mRNA vaccines are safe because they are not made with pathogen particles or inactivated pathogens; therefore, they are non-infectious. RNA does not integrate itself into the host genome and the RNA strand in the vaccine is degraded once the protein is made.

Due to the high yields of in vitro transcription reactions, mRNA vaccines have the potential for rapid, inexpensive and scalable manufacturing.

mRNA vaccines can be used for infectious diseases, particularly for viruses, that cause both acute (Influenza, Ebola, Zika, etc.) and chronic (HIV-1, herpes simplex virus, etc.) infections.

Cancer vaccines can be designed to target tumor-associated antigens that are preferentially expressed in cancerous cells, for example, blood cancers, melanoma, glioblastoma (brain cancer), renal cell carcinoma, prostate cancer, etc. Most cancer vaccines are therapeutic, rather than prophylactic, and seek to stimulate cell-mediated responses, such as those from CTLs, that are capable of clearing or reducing tumor burden.

Four of the vaccine candidates currently in clinical trials to prevent COVID-19 are mRNA vaccines: mRNA-1273 (Moderna), BNT-162 (BioNTech), CVnCoV (CureVac), and LNP-nCoVsaRNA (Imperial College London).

Types of RNA vaccine

Protection by Patent

Patent Rights play an important role in encouraging investment on research of new technologies. The patent system is designed to support innovation and, at the same time, offer a mechanism to ensure that such innovations are accessible to society. Published patents and patent applications are an important source of technical and legal information.

Scientists have studied the use of mRNA as a novel therapeutic since the early 1990s. The first patent family identified was published in 1990. However, it was not until 2005 that a group of researchers from the University of Pennsylvania published findings on mRNA technology that have since been deemed critical to the development of mRNA-based therapies. US Securities and Exchange Commission filings, highlighted by Knowledge Ecology International, reveal a series of sublicenses for mRNA-related patents that stem from the University of Pennsylvania to both Moderna and BioNTech. The 2017 filings indicate that the University of Pennsylvania exclusively licensed their patents to mRNA RiboTherapeutics, which then sublicensed them to its affiliate CellScript. CellScript proceeded to sublicense the patents to Moderna and BioNTech; however, the patent numbers are redacted in all the filings, making it difficult to determine which are relevant to the production of COVID-19 vaccines.

Another key aspect of an mRNA vaccine platform is the ability to deliver the mRNA to a cell using a lipid nanoparticle. Some early work on lipid nanoparticles was done jointly by the University of British Columbia and Arbutus Biopharmaceuticals in 1998. US Securities and Exchange Commission filings show that patents relating to this early technology were solely assigned to the University of British Columbia and then licensed back to Arbutus.

Patent-filing activity grew dramatically over the past 5 years for both infectious disease and cancer indications. The number of applications for infectious disease indications surpassed those for cancer over the past 3 years, which could reflect increased interest in vaccines following epidemic outbreaks of MERS-CoV, Ebola virus and Zika virus. In August 2019, Moderna received FDA Fast Track Designation for an investigational Zika virus vaccine (mRNA-1893) currently being evaluated in a phase I study.

According to PATENTSCOPE WIPO, from 2012 to 2021, 1,834 patent applications related with mRNA have been published. The main filing countries are the following:

The applicants who have filed the most patent application are listed below:

The present IP landscape includes foundational patents in modified mRNA technologies and delivery technologies that are essential for mRNA therapeutics and vaccines, including their application in specific unmet needs in infectious diseases, cancer (immuno-oncology), and rare and cardiometabolic diseases, among others.

Compulsory licenses

Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself. It is one of the flexibilities in the field of patent protection included in the WTOs agreement on Intellectual Property Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

To explain the public policy objectives for a compulsory licensing mechanism, countries refer to striking a balance between the interest of patentees and that of third parties, public interest, and/or society; preventing abuses that may result from the exercise of exclusive rights; and promoting the public interest at large, such as in situations of public interest and emergency motivated by considerations of public health, nutrition, and national security. Some possible grounds for compulsory licensing are suggested in Article 5A of the Paris Convention (e.g., abuse of patent rights, including failure of the patent holder to work the invention) and in Article 31 of the TRIPS Agreement (e.g., national emergency and public noncommercial use).

Compulsory licenses are thus not limited to public health emergencies or other urgent situations, as is sometimes mistakenly believed. A range of grounds have been set out in national laws, such as:

In Mexico, compulsory licenses can be granted based on articles 146-153 of the Federal Law for the Protection of Industrial Property, which states they can be granted for non-working the patent and national emergency or circumstances of extreme urgency:

In cases of serious diseases, the General Health Council will declare priority attention, ex officio or at the request of national institutions specialized in said disease that are accredited before it, in which the causes of emergency or national security are justified. Once the declaration issued by the Council has been published in the Official Gazette, pharmaceutical companies may request the granting of a license of public utility to the Institute, which will grant it, after hearing the parties and the opinion of the Council, within a period not exceeding ninety days from the date of submission of the respective application

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nations public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies, such as the current COVID19 pandemic.

Under an Emergency Use Authorization, FDA may allow the use of unapproved medical products -or unapproved uses of approved medical products- in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an Emergency Use Authorization request to FDA. Once submitted, FDA will evaluate the Emergency Use Authorization request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.

There are no specific guidelines from the FDA or European Medicines Agency (EMA) for mRNA vaccine products. However, the increasing number of clinical trials conducted under EMA and FDA oversight indicate that regulators have accepted the approaches proposed by various organizations to demonstrate that products are safe and acceptable for testing in humans. Because mRNA falls into the broad vaccine category of genetic immunogens, many of the guiding principles that have been defined for DNA vaccines and gene therapy vectors can likely be applied to mRNA with some adaptations to reflect the unique features of mRNA.

Emergency use of vaccines in Mexico

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the health authority responsible for protecting the Mexican population from the risks that may arise from the consumption or use of medicines and medical devices, as well as from those derived from the consumption of food and of other products that we use on a daily basis, while also issuing import and export permits for these products.

The Mexican Government published on March 30, 2020 the agreement declaring a health emergency due to force majeure, the disease epidemic generated by the SARS-CoV2 virus (COVID-19). Furthermore, on November 11, 2020, it published an Agreement instructing the Ministry of Health and the Federal Commission for the Protection against Sanitary Risks to carry out the following actions:

CONCLUSIONS

Unwarranted restrictions on competition, whether resulting from the abuse of a dominant position resulting from intellectual property rights or other factors, or from anti-competitive agreements, can be addressed through competition law enforcement. Regarding innovation, a key concern is merger control, where competition authorities must ensure that mergers do not threaten R&D pipelines.

Incremental innovation can improve the safety, therapeutic effect or method of delivery of an existing medicine or vaccine. Whether such inventions merit the granting of a patent is judged on a case-by-case basis.

Regulation should promote access to medical technologies of proven quality, safety and efficacy and should not unnecessarily delay the market entry of products.

Challenges for regulatory systems that impact access include lack of political support and adequate resources, a focus on regulating products without effective oversight of the whole supply chain, poorly developed systems for post-marketing surveillance, and different standards for locally produced versus imported products.

In this area, both regulatory and IP tools can be used in a complementary way to combat substandard and falsified products.

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EAPM: Presidency bridging conference a great success, HTA compromise agreed and data on the agenda – EU Reporter

Tuesday, July 6th, 2021

Good morning and welcome, health colleagues, to the second European Alliance for Personalised Medicine (EAPM) update of the week as it stands, more than 150 people have now registered for our upcoming EAPM Slovenian EU Presidency conference on 1 July, so now is the time to join them and book your place before its too late,and we also have an update on the European Parliaments draft report on strengthening Europe in the fight against cancer,writes EAPM Executive Director Dr. Denis Horgan.

EAPM conference approaches - a reminder yet again...

The EAPM conference will act as a bridging event between the EU Presidencies ofPortugalandSlovenia.The conference is divided into sessions which cover the follows areas: Session 1: Generating alignment in the regulation of Personalized Medicine: RWE and Citizen Trus;Session 2: Beating Prostate Cancer and Lung Cancer - The Role of the EU Beating Cancer: Updating EU Council Conclusions on ScreeningSession 3: Health Literacy - Understanding Ownership and Privacy of Genetic Data and finallynot least,Session 4: Securing patient Access to Advanced Molecular Diagnostics.

Each session will comprise panel discussions as well as Q&A sessions to allow the best possible involvement of all participants, so now is the time to registerhere, and download your agendahere.

Battling cancer Parliaments key draft report

As mentioned in previous updates, the European Parliament has set up a special committee on beating cancer. It has published its first draft report on the EU Beating Cancer Plan on the last day, which has included a number of items which the EAPM has advocated for in the last months representing key issues representing themulti-stakeholder nature of its membership.

Subdivided into numerous articles, article 66 in the report is of particular attention to EAPM members, saying as it does that huge advances in biology have revealed that cancer is an umbrella term for more than 200 diseases, and that precision or personalised medicine can be made available through the drug targeting of various mutations.

The report also considers that precision or personalised medicine, consisting of a treatment choice based on individual tumour biomarkers, is a promising way to improve cancer treatment, and encourages member states to promote the implementation of regional molecular genetics platforms and facilitate equal and rapid access to personalised treatment for patients.

In addition, article 48 in the draft report calls on the Commission to promote, and on member states to strengthen, the role of general practitioners, paediatricians and primary care professionals, given their importance in patient referral to diagnostic tests and oncology specialists, as well as during cancertreatment and follow-up care; calls for the development of multidisciplinary decision-making in the framework of dedicated concertation meetings bringing together various cancer specialists.

According to article 61, the provisional agreement on the Health Technology Assessment (HTA) Regulation reached by the European Parliament and the Council on 22 June 2021 is welcomed, to harmonize access to innovative cancer diagnosis and treatments.

Perhaps most importantly, article 87 sees an urgent need for a European charter of the rights of cancer patients; calls for this charter to define the rights of cancer patients at every stage of their care pathway, i.e. access to prevention, initial diagnosis and throughout their treatment, and for it to apply equally to all EU citizens, regardless of the country or region in which they live.

In addition, article 105 looks to the Cancer Diagnostic and Treatment for All flagship and puts a spotlight on the need for the use of the next generation sequencing technology for quick and efficient genetic profiles of tumour cells, allowing researchers and clinicians to share cancer profiles and apply the same or similar diagnostic and therapeutic approaches to patients with comparable cancer profiles.

EAPM looks forward with enthusiasm to all forward progress being made in the fight against cancer. In this context, EAPM is working on two publications with its experts on NGS and RWE which will provide additional input/guidance to the European politicians which EAPM is working with.

HTA political agreement

The Commission welcomes the political agreement on the Health Technology Assessment (HTA) Regulation reached by the European Parliament and the Council on 23 June. The Regulation will improve the availability of innovative health technologies such as innovative medicines and certain medical devices for EU patients, ensure efficient use of resources and strengthen the quality of HTA across the EU. Examples of health technologies include medicinal products, medical equipment and diagnostics. It will also facilitate business predictability, reduce duplication of efforts for HTA bodies and industry and ensure the long-term sustainability of EU HTA co-operation.

Welcoming the agreement, Commissioner for Health and Food Safety Stella Kyriakides made the following statement: I am very pleased that the European Parliament and the Council have reached a long-awaited political agreement on the Health Technology AssessmentRegulation. The Regulation will be a significant step forward to enable joint scientific assessments of promising treatments and medical devices at EU level.

Progress on vaccinations welcomed, but further effort urged

The European Council welcomes the good progress on vaccination and the overall improvement in the epidemiological situation, while stressing the need to continue vaccination efforts and to be vigilant and co-ordinated with regard to developments, particularly the emergence and spread of variants.

According to the draft European Council conclusions for the June 24-25 meeting, the Council stated that it reaffirms the EUs commitment to international solidarity in response to the pandemic.

All producing countries and manufacturers should actively contribute to efforts to increase worldwide supply of COVID-19 vaccines, raw material, treatments and therapeutics, and coordinate action in case of bottlenecks in supply and distribution, the draft text declares.

The conclusions also reference recent agreements on travel within the EU, stating that member countries would apply these measures in a manner that ensures the full return to free movement as soon as the public health situation allows. The Council also plans to welcome the decision to set up a special session for the World Health Assembly to discuss a pandemic treaty, with the EU saying that it will continue to work toward a goal of a treaty.

WHO, WIPO and the WTO agree on intensified co-operation to tackle COVID-19 pandemic

On 15 June, the directors general of WHO, WIPO and the WTO met in a spirit of co-operation and solidarity to map out further collaboration to tackle the COVID-19 pandemic and the pressing global challenges at the intersection of public health, intellectual property and trade.Acutely conscious of the shared responsibility to communities across the world as they confront a health crisis of unprecedented severity and scale, the organizations pledged to bring the full extent of the expertise and resources of the respective institutions to bear in ending the COVID-19 pandemic and improving the health and well-being of all people, everywhere around the globe.

Commitment to universal, equitable access to COVID-19 vaccines, therapeutics, diagnostics, and other health technologies was underscored a commitment anchored in the understanding that this is an urgent moral imperative in need of immediate practical action.In this spirit, there was an agreement to build further on the long-standing commitment to WHO-WIPO-WTO Trilateral Cooperation that aims to support and assist all countries as they seek to assess and implement sustainable and integrated solutions to public health challenges.

Within this existing cooperative framework, it was agreed to enhance and focus our support in the context of the pandemic through two specific initiatives - the three agencies will collaborate on the organization of practical, capacity-building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies. The aim of these workshops is to strengthen the capacity of policymakers and experts in member governments to address the pandemic accordingly.The first workshop in the series will be a workshop on technology transfer and licensing, scheduled for September.

Long COVID concerns

More than 2 million adults in England have experienced coronavirus symptoms lasting over 12 weeks, such as respiratory problems and fatigue, government data suggests. It is double the previous estimate for long Covid. The research by the React-2 study, which has not yet been peer-reviewed, found that 37.7% of those who had symptomatic Covid experienced at least one symptom lasting 12 weeks or more, while 14.8% had three or more persistent symptoms. The scale of the problem is quite alarming, said Professor Kevin McConway, emeritus professor of applied statistics at the Open University. It comes as more than 16,000 new confirmed Covid cases were reported in the UK on Wednesday (23 June), the highest daily figure since early February. The newest figures showed another 19 people had died within 28 days of testing positive for Covid-19, bringing the UK total to 128,027. While death figures remain relatively low, the sharp rise in reported cases would appear to make it less likely that ministers will scrap most remaining Covid restrictions before the current four-week delay ends on 19 July.

Switzerland to re-open

While countries such as the UK delay their planned lifting of restrictions (as it stands, until 19 July in the case of the UK), Switzerland has announced an even more wide-ranging lifting of restrictions than previously planned. Citizens will no longer be required to work from home; they wont have to wear masks or social distance at cultural and sporting events; and mass events can go ahead without restrictions on numbers or the need for masks if theres a requirement for coronavirus certificates.

And that is all from EAPM for this week have a lovely weekend, stay safe and well, and dont forget to registerhere, and download your agendahere,for the EAPM EU Presidency conference on 1 July.

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Cell and Gene Therapy Drug Delivery Devices Market, 2030 – Market Opportunities in the Strong Pipeline of Cell and Gene Therapies – PRNewswire

Sunday, April 4th, 2021

DUBLIN, March 30, 2021 /PRNewswire/ -- The "Global Cell and Gene Therapy Drug Delivery Devices Market: Focus on Product Type, Commercialized Drug Delivery Devices, Country Data (16 Countries), and Competitive Landscape - Analysis and Forecast, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

The global cell and gene therapy drug delivery devices market was valued at $55.75 thousand in 2019, and is expected to reach $375.13 thousand by 2030, registering a CAGR of 16.61% during the forecast.

Cell and gene therapy drug delivery industry is a transformative industry whose full potential is only just beginning to emerge. Cell and gene therapy involves the extraction of cells, protein, or genetic material (DNA) from the donor, and altering them to provide highly personalized therapy. Cell and gene therapies may offer longer-lasting effects than traditional medicines.

One of the significant drugs of the cell and gene therapy industry is CAR-T cell-based medicines, which include both cell therapy and gene therapy. Various market players are actively investing in the research and development of the cell and gene therapy industry. The players are offering improved and new products, which meet the critical needs of patients.

The growth is attributed to major drivers in this market such as the increasing prevalence of cancer and chronic diseases, increased funding in the cell and gene therapy market, rising need to develop novel treatment options for rare diseases, and rising biopharmaceutical R&D expenditure, and rising number of the FDA approvals of cell and gene therapies & clinical trials. The market is expected to grow at a significant growth rate due to various potential opportunities of growth that lie within its domain, which include drug approvals and strong pipeline of cell and gene therapies.

Various new cell and gene-based therapy approaches use biological engineering to improve the immune system's capacity to fight disease while sparing healthy tissues in the body. For instance, there are antibody-based therapies that can make T-cells more effective by increasing their interactions with cancer cells. Other modifications, such as adding complexity to the CAR-T and cancer cell interaction, which can further sharpen T-cells' cancer-targeting ability by reducing damage to normal cells.

The increase in the geriatric population and an increasing number of cancer cases, and genetic disorders across the globe are expected to translate into significantly higher demand for cell and gene therapy drug delivery devices market.

Furthermore, the companies are investing huge amount in research and development of cell and gene therapies and associated drug delivery devices products. The clinical trial landscape of various genetic and chronic diseases has been on the rise in the recent years, this will fuel the cell and gene therapy drug delivery devices market in future.

Within the research report, the market is segmented based on product type, commercialized drugs, and region. Each of these segments covers the snapshot of the market over the projected years, the inclination of the market revenue, underlying patterns, and trends by using analytics on the primary and secondary data obtained.

Competitive Landscape

The exponential rise in the application of precision medicine on a global level has created a buzz among companies to invest in the development of novel cell and gene therapy drug delivery devices.

Due to the diverse product portfolio and intense market penetration, Novartis AG, Kite Pharma Inc., and Dendreon Pharmaceuticals LLC. have been the pioneers in this field and been the major competitors in this market.

The other major contributors of the market include companies such as Vericel Corporation, Amgen Inc., Bausch & Lomb Incorporated, Spark Therapeutics, Inc., and Becton, Dickinson and Company.

Based on region, North America holds the largest share of cell and gene therapy drug delivery devices market due to substantial investments made by biotechnology and pharmaceutical companies, improved healthcare infrastructure, rise in per capita income, early availability of approved therapies, and availability of state-of-the-art research laboratories and institutions in the region. Apart from this, Asia-Pacific region is anticipated to grow at the fastest CAGR during the forecast period.

Key Topics Covered:

1 Technology Definition

2 Research Scope

3 Key Questions Answered in the Report

4 Research Methodology

5 Market Overview5.1 Introduction5.2 Cell and Gene Therapies and Drug Delivery Devices Industry5.3 Cell and Gene Therapy Drugs and Their Clinical Importance5.4 Cell and Gene Therapy Drug Delivery Devices Market: Current Scenario5.5 Cell and Gene Therapy Drug Delivery Devices Market: Future Perspective

6 Global Cell and Gene Therapy Drug Delivery Devices Market and Growth Potential, 2020-20306.1 Overview6.2 Pipeline Analysis6.2.1 Drug Delivery Systems in Development: Current Scenario6.2.1.1 Ongoing Clinical Trials of Drug Delivery Systems6.2.1.2 Limitations of Cell and Gene Therapy Drug Delivery Devices6.2.1.3 Recent Advancements in Gene Therapy Drug Delivery6.3 Cell and Gene Therapy Drug Delivery Devices Market and Growth Potential6.4 Cell and Gene Therapy Drug Development and Commercialization Landscape6.5 Impact of COVID-19 on Cell and Gene Therapy Drug Delivery Devices Market6.5.1 Impact of COVID-19 on Global Cell and Gene Therapy Drug Delivery Devices Market Growth Rate6.5.2 Impact of COVID-19 on Supply Chain of Cell and Gene Therapy Drug Delivery Devices Market6.5.3 Clinical Trial Disruptions and Resumptions

7 Emerging Technology Landscape7.1 Potential Technologies in Cell and Gene Therapy Drug Delivery Devices Market7.2 Microchip Technology7.3 Nanotechnology-Based Drug Delivery Devices7.4 Lipid Nanoparticles in Gene Therapy

8 Market Dynamics8.1 Impact Analysis8.2 Market Drivers8.2.1 Increasing Prevalence of Cancer and Chronic Diseases8.2.2 Increased Funding of Cell and Gene Therapies8.2.3 Rising Number of FDA Approvals of Cell and Gene Therapies, and Clinical Trials8.3 Market Restraints8.3.1 Stringent Legal Requirements and Regulations8.3.2 Injuries and Infections Caused by Needles8.4 Market Opportunities8.4.1 Strong Pipeline of Cell and Gene Therapies

9 Industry Insights9.1 Regulatory Scenario of Cell and Gene Therapy Drug Delivery Devices Market9.1.1 Overview9.1.2 Risk Assessment of Medical Devices9.1.3 Regulation of Medical Devices in the U.S.9.1.4 Regulation of Medical Devices in Europe9.1.5 Regulation of Medical Devices in Asia-Pacific9.2 Pricing and Reimbursement of Cell and Gene Therapy Drug Delivery Devices

10 Patent Landscape

11 Global Cell and Gene Therapy Drug Delivery Devices Market (by Product Type)11.1 Overview11.2 Subretinal Injection Cannula11.3 Extension Tube11.4 Intravenous Catheter11.5 Sterile Insulin Syringe11.5.1 Sterile Insulin Syringe (Size 1.0 ML, 31-Gauge Needle)11.5.2 Sterile Insulin Syringe (Size 0.5 ML, 22 Gauge Needle)11.6 Pre-Filled Syringe11.6.1 Pre-Filled Syringe (Size 1.0 ML, 22-26 Gauge Needle)11.6.2 Pre-Filled Syringe (Size 4.0 ML, 22-26 Gauge Needle)11.7 Infusion Bags11.7.1 Infusion Bags (Size 10 ML to 50 ML)11.7.2 Infusion Bags (Size 68 ML)11.7.3 Infusion Bags (Size 60 ML)11.7.4 Infusion Bags (Size Up to 65 ML)

12 Global Cell and Gene Therapy Drug Delivery Devices Market (by Commercialized Drugs)12.1 Commercialized Drugs12.1.1 Luxturna12.1.2 Kymriah12.1.3 Provenge12.1.4 Zolgensma12.1.5 Yescarta12.1.6 Strimvelis

13 Global Cell and Gene Therapy Drug Delivery Devices Market (by Region)13.1 Overview

14 Competitive Landscape14.1 Key Developments and Strategies14.1.1 Overview14.1.2 Regulatory and Legal Developments14.1.3 Synergistic Activities14.1.4 M&A Activities14.1.5 Funding Activities14.2 Market Share Analysis

15 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/2mcxqt

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

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

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Legally blind Great Falls filmmakers share their vision in national challenge – Yahoo News

Sunday, April 4th, 2021

The Daily Beast

Getty/Facebook Two weeks before he allegedly rammed his car into two police officers guarding the U.S. Capitol, killing one of them, Noah Green posted an article on his Facebook page titled, Lull Before the Storm.An Intro to the Honorable Elijah Muhammad and his divine warning to us all during these last days of our world as we know it. Satans rule over us is up, the 25-year-olds apocalyptic post said, linking to an article from Final Call, the official newspaper of the Nation of Islam.Greens social media posts suggest he was spiraling in the lead up to the attack on Friday. On the eve of his alleged assault, his brother, Brendan Green, told The Washington Post, he sent a worrying text after leaving the apartment where they lived together for the past few months.Im sorry but Im just going to go and live and be homeless. Thank you for everything that youve done. I looked up to you when I was a kid. You inspired me a lot, the text reportedly read. That messageand the deadly attack that occurred less than 24 hours latercapped off a period that was riddled with red flags. Officer Killed, Driver Fatally Shot After Ramming Into Capitol Building BarricadeAs congressional staff grabbed lunch on Friday, Green allegedly rammed his dark blue sedan into two officers guarding a barricade on a road outside the Capitol.He then jumped out of the car and lunged at officers with a knife, U.S. Capitol Police Chief Yogananda Pittman said, prompting them to fatally shoot him. A senior law enforcement official confirmed to The Daily Beast that Green was the suspect, though he has not yet been officially identified by police. One Capitol Police officer, William Billy Evans, died, and a second officer was left hospitalized. He was said to be in stable condition late Friday.Pittman said the suspect was not known to Capitol Police before the attack and there was no indication of any nexus to members of Congress. She also said there was no ongoing threat and the suspect didnt yell anything before being shot. She said that, while an investigation was ongoing, it did not appear to be terrorism-related.Greens social media posts last month described searching for a spiritual journey within the Nation of Islam, a religious Muslim sect that the Southern Poverty Law Center classifies as a hate group for its bizarre theology of innate black superiority over whites and deeply racist, antisemitic and anti-gay rhetoric.In a statement on Saturday, Greens family expressed sympathy for the officer who was killed on Friday, and said they were just as taken aback as the rest of the nation from this horrific event. Still, the family said, Green suffered from depression and potential mental illness, and had likely fell ill to the multitude of problematic situations that surround us in todays society. They also suggested head injuries he sustained playing football may have contributed to his mental state. Nothing indicated a clear motive for targeting the police, nor the U.S. Capitol building located hours from both the Indianapolis apartment he had recently lived in, and the semi-rural part of Virginia he grew up in.In two lengthy March 17 posts on Greens Facebook profile, which was taken down shortly after the incident, Green wrote about losing his job and being unwittingly drugged. He said it was a major goal to meet Nation of Islam leader Louis Farrakhan.There was no immediate indication that Fridays attack was religiously motivated, and the Nation of Islams Virginia branch and D.C. headquarters did not immediately respond to requests for comment.Green wrote about suffering unspecified setbacks in his life recently.To be honest these past few years have been tough, and these past few months have been tougher, he wrote in the March 17 post. I have been tried with some of the biggest, unimaginable tests in my life. I am currently now unemployed after I left my job partly due to afflictions, but ultimately, in search of a spiritual journey.Despite the lack of a job, he posted an image of a certificate that said hed donated $1,085 to the Nation of Islam as a Saviours Day 2021 gift.Greens brother, Brendan, told the Post that Noah had become paranoid in 2019 and accused football teammates of drugging him with Xanax. He moved out to his own apartment and then abruptly moved to Indianapolis, where he believed there were intruders getting into his apartment. It was around that time that Brendan said he flew out to see his brother and realized his mind didnt seem right.More recently, his brother said, Green up and moved to Botswana and suggested he had tried to take his own life by jumping in front of a car. After he returned home, Noah Green appeared to view the Nation of Islam as a way to keep himself anchored. In his most recent social media posts, Green wrote that he had been faced with fear, hunger, loss of wealth, and diminution of fruit in recent months, and was being sustained by faith centered on the belief of the Honorable Minister Louis Farrakhan as Jesus, the Messiah.He posted that he had graduated with distinction, landed a good job out of college, and pursued a graduate degree despite not growing up in the best of circumstances. He said he was on track to go into business, but his path was thwarted. Green wrote that he partially blamed his setbacks on the array of concerning symptoms he suffered as side effects of drugs I was intaking unknowinglyperhaps alluding to the alleged incident in 2019. Noah Green played football for Christopher Newport University and graduated in 2019. CNU Green played football in high school, and a bio from Christopher Newport University said he was born in Fairlea, West Virginia, and has seven brothers and two sisters. He grew up in a semi-rural area in Covington, Virginia. Calls to his siblings and parents went unanswered on Friday.Public records show he enrolled in a graduate course at Florida State University this year, after majoring in marketing at Glenville State College.In the Christopher Newport bio, he said his dream vacation spot was Jamaica and the person hed most like to meet was Malcolm X.Friends appeared shocked that the outgoing, football-playing, marketing student they knew was the same person they saw being stretchered from the Capitol on Friday.He was always super sweet to me and all of his friends loved him, we were all sad to see him leave Glenville, Alaina Funk, a friend of the suspect, told The Daily Beast.It was unclear from his Facebook page how recently he became involved with Nation of Islam. Older posts centered around football and college rather than religion. His grandmother, who died in 2019 from a long illness, was Baptist, her obituary said.But, by March, Greens posts appeared to be consumed by religious warnings about the end days.I encourage everyone to study Revelations, study the signs of the end times, study who the beast is, study who the anti-Christ is, study who the false prophet is, and study the created images during those times. The Minister is here to save me and the rest of humanity, even if it means facing death, he wrote on March 17, before ominously ending the post with, We have a little time.Court records in Indiana, where he temporarily lived in an Indianapolis apartment, show that he sought to change his name recently. In December 2020, he filed a petition to legally change his name to Noah Zaeem Muhammad. But after he failed to show up for a hearing earlier this week and the court apparently did not hear from him, the matter was dismissed and the case declared closed.with reporting by Pilar MelendezRead more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

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Pfizer Announces Vaccine Is 100% Protective Against Coronavirus In Kids As Young As 12 – Yahoo News

Sunday, April 4th, 2021

The Daily Beast

Getty/Facebook Two weeks before he allegedly rammed his car into two police officers guarding the U.S. Capitol, killing one of them, Noah Green posted an article on his Facebook page titled, Lull Before the Storm.An Intro to the Honorable Elijah Muhammad and his divine warning to us all during these last days of our world as we know it. Satans rule over us is up, the 25-year-olds apocalyptic post said, linking to an article from Final Call, the official newspaper of the Nation of Islam.Greens social media posts suggest he was spiraling in the lead up to the attack on Friday. On the eve of his alleged assault, his brother, Brendan Green, told The Washington Post, he sent a worrying text after leaving the apartment where they lived together for the past few months.Im sorry but Im just going to go and live and be homeless. Thank you for everything that youve done. I looked up to you when I was a kid. You inspired me a lot, the text reportedly read. That messageand the deadly attack that occurred less than 24 hours latercapped off a period that was riddled with red flags. Officer Killed, Driver Fatally Shot After Ramming Into Capitol Building BarricadeAs congressional staff grabbed lunch on Friday, Green allegedly rammed his dark blue sedan into two officers guarding a barricade on a road outside the Capitol.He then jumped out of the car and lunged at officers with a knife, U.S. Capitol Police Chief Yogananda Pittman said, prompting them to fatally shoot him. A senior law enforcement official confirmed to The Daily Beast that Green was the suspect, though he has not yet been officially identified by police. One Capitol Police officer, William Billy Evans, died, and a second officer was left hospitalized. He was said to be in stable condition late Friday.Pittman said the suspect was not known to Capitol Police before the attack and there was no indication of any nexus to members of Congress. She also said there was no ongoing threat and the suspect didnt yell anything before being shot. She said that, while an investigation was ongoing, it did not appear to be terrorism-related.Greens social media posts last month described searching for a spiritual journey within the Nation of Islam, a religious Muslim sect that the Southern Poverty Law Center classifies as a hate group for its bizarre theology of innate black superiority over whites and deeply racist, antisemitic and anti-gay rhetoric.In a statement on Saturday, Greens family expressed sympathy for the officer who was killed on Friday, and said they were just as taken aback as the rest of the nation from this horrific event. Still, the family said, Green suffered from depression and potential mental illness, and had likely fell ill to the multitude of problematic situations that surround us in todays society. They also suggested head injuries he sustained playing football may have contributed to his mental state. Nothing indicated a clear motive for targeting the police, nor the U.S. Capitol building located hours from both the Indianapolis apartment he had recently lived in, and the semi-rural part of Virginia he grew up in.In two lengthy March 17 posts on Greens Facebook profile, which was taken down shortly after the incident, Green wrote about losing his job and being unwittingly drugged. He said it was a major goal to meet Nation of Islam leader Louis Farrakhan.There was no immediate indication that Fridays attack was religiously motivated, and the Nation of Islams Virginia branch and D.C. headquarters did not immediately respond to requests for comment.Green wrote about suffering unspecified setbacks in his life recently.To be honest these past few years have been tough, and these past few months have been tougher, he wrote in the March 17 post. I have been tried with some of the biggest, unimaginable tests in my life. I am currently now unemployed after I left my job partly due to afflictions, but ultimately, in search of a spiritual journey.Despite the lack of a job, he posted an image of a certificate that said hed donated $1,085 to the Nation of Islam as a Saviours Day 2021 gift.Greens brother, Brendan, told the Post that Noah had become paranoid in 2019 and accused football teammates of drugging him with Xanax. He moved out to his own apartment and then abruptly moved to Indianapolis, where he believed there were intruders getting into his apartment. It was around that time that Brendan said he flew out to see his brother and realized his mind didnt seem right.More recently, his brother said, Green up and moved to Botswana and suggested he had tried to take his own life by jumping in front of a car. After he returned home, Noah Green appeared to view the Nation of Islam as a way to keep himself anchored. In his most recent social media posts, Green wrote that he had been faced with fear, hunger, loss of wealth, and diminution of fruit in recent months, and was being sustained by faith centered on the belief of the Honorable Minister Louis Farrakhan as Jesus, the Messiah.He posted that he had graduated with distinction, landed a good job out of college, and pursued a graduate degree despite not growing up in the best of circumstances. He said he was on track to go into business, but his path was thwarted. Green wrote that he partially blamed his setbacks on the array of concerning symptoms he suffered as side effects of drugs I was intaking unknowinglyperhaps alluding to the alleged incident in 2019. Noah Green played football for Christopher Newport University and graduated in 2019. CNU Green played football in high school, and a bio from Christopher Newport University said he was born in Fairlea, West Virginia, and has seven brothers and two sisters. He grew up in a semi-rural area in Covington, Virginia. Calls to his siblings and parents went unanswered on Friday.Public records show he enrolled in a graduate course at Florida State University this year, after majoring in marketing at Glenville State College.In the Christopher Newport bio, he said his dream vacation spot was Jamaica and the person hed most like to meet was Malcolm X.Friends appeared shocked that the outgoing, football-playing, marketing student they knew was the same person they saw being stretchered from the Capitol on Friday.He was always super sweet to me and all of his friends loved him, we were all sad to see him leave Glenville, Alaina Funk, a friend of the suspect, told The Daily Beast.It was unclear from his Facebook page how recently he became involved with Nation of Islam. Older posts centered around football and college rather than religion. His grandmother, who died in 2019 from a long illness, was Baptist, her obituary said.But, by March, Greens posts appeared to be consumed by religious warnings about the end days.I encourage everyone to study Revelations, study the signs of the end times, study who the beast is, study who the anti-Christ is, study who the false prophet is, and study the created images during those times. The Minister is here to save me and the rest of humanity, even if it means facing death, he wrote on March 17, before ominously ending the post with, We have a little time.Court records in Indiana, where he temporarily lived in an Indianapolis apartment, show that he sought to change his name recently. In December 2020, he filed a petition to legally change his name to Noah Zaeem Muhammad. But after he failed to show up for a hearing earlier this week and the court apparently did not hear from him, the matter was dismissed and the case declared closed.with reporting by Pilar MelendezRead more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

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How the law will change in 2021 – Lexology

Thursday, February 11th, 2021

The changes brought by the COVID-19 pandemic have had an impact across society, and courts and IP offices are no exception. As part of our series of articles looking at what to expect in 2021, Kilburn & Strode attorneys discuss some of the legal developments on the horizon.

Its not just business meetings, webinars and Christmas quizzes that are suited to Zoom; court and IP office hearings are increasingly conducted virtually too.

At the EPO, oral proceedings in examination and oppositions will be heldonlineunless there are exceptional circumstances until September 2021 (at least). Board of Appeal hearings are heading the same way. While some practitioners have been sceptical about these changes, at Kilburn & Strode we see video conferencing as a hugely powerful and accessible medium for getting to a good decision quickly.

This is good news for SMEs, who may now be able to afford to fight cases they couldnt otherwise, says associate Rosie Carrie. But, she adds, the long-term implications are hard to predict: Will parties be more likely to be confrontational when not seeing each other in person? Will they pursue arguments more strongly? Will the opportunity to resolve issues in an informal setting be missed?

At the EUIPO, there may be changes too. Areformin 2019 overlooked by many people at the time means that the CJEU now accepts appeals from the EU General Court only where they raise an issue that is significant with respect to the unity, consistency or development of EU law. In practice, this means the General Court is now the final arbiter for most cases involving EU trade marks and registered Community designs. That may lead to the EUIPO Boards of Appeal holding more oral hearings between parties, something that until now has been extremely rare.

Patent priorities

With normal routines disrupted and the opportunity to reflect, the pandemic has led many people to consider their values and priorities getting fit, learning new hobbies or their social and political values. Policy debates about the balance between competition and innovation, between access and reward; or between control and free speech have always been part of IP. In this new environment, will we see them become even more prominent?

In patents, for example, partnerNick Bassilsays he increasingly sees morality issues being raised regarding patents for stem cells, gene therapy etc, arising from the ordre public (public policy) and morality exception in Article 53(a) of the EPC: This will become more and more relevant with genetic medicine. More generally, debates about access to medicine, the role of patents, pricing mechanisms and sourcing of drugs are gaining attention as the pandemic increases awareness (if not understanding) of the role of medicine (see our separate article on political and social trends).

On your marks

In trade marks, meanwhile, debates are continuing about the proper scope of protection and whether making broad and/or multiple related trade mark applications should be discouraged (including on the grounds of bad faith). These issues were not fully resolved in last yearsSkyKickdecision from the CJEU, but should be addressed further in the MONOPOLY case pending before the EU General Court.

Trade mark partnerIain Stewartsays: These debates reflect wider concerns about the cluttering of trade mark registers. One view is that unlike in the US where there are strict use requirements, in Europe there are too many marks that are registered but not used. It means clearance searches in the EU are becoming a nightmare. Sometimes the results run to dozens of pages, explains Iain. As well as being a practical challenge for those seeking to apply for trade marks, particularly internationally, cluttering raises questions about the accessibility of the trade mark system and its ability to serve all users, especially SMEs.

UPC or not UPC?

The end of 2020 saw Germany take important steps towards ratifying the Unified Patent Court (UPC) Agreement, raising the possibility that it could theoretically come into effect, though significant legal challenges remain (meaning ratification by Germany and implementation in 2021 is unlikely).Gwilym Robertssays: The UPC was always a lofty ideal and the simplification it offers remains attractive. But with the continuing legal challenges it faces one wonders if its time to look at alternative multilateral arrangements bringing the same benefits.Whatever comes out Kilburn & Strode will continue to be a part of it as we continue to expand our European presence.

Read article three here

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How the law will change in 2021 - Lexology

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Writing is the best medicine – The London Economic

Thursday, February 11th, 2021

In addition to carving out a distinguished medical career, Dr Cliff Bacchus has built a reputation as a novelist unafraid to tackle challenging social issues, most recently the practice of intermarriage between cousins.

By the time they reach their sixties, most people would be looking forward to retiring and taking things easier. For medical doctor Dr Cliff Bacchus, however, it marked the launch of a second career as a novelist.

Now aged 78, Dr Bacchus has published three critically-acclaimed novels within the last 15 years, with the latest gripping psychological thriller Curses of Cousins just released.

For the Bahamas-based author, who also runs two busy pain management clinics in the country, writing is a much-needed creative escape from the pressures of the day job.

Since 1974, he has served the medical needs of the Bahamian island that has been his adopted home since he left his native Guyana to study medicine in what was then Communist Russia.

During all that time, he has consulted the rich, the famous, and the less fortunate with equal attention, and care for all, initially as a senior medial officer working for the government before going into private practice in the early 2000s.

His standing as a physician also led him to be cast as a doctor in 2007 Bahamas-set Hollywood film Bad Girl Island after he conducted the medical examinations for the director, Stewart Raffill, and crew.

Perhaps somewhat unsurprisingly, Dr Bacchus draws heavily upon his training and experiences for his novels also including his literary debut, 2007s A Doctor and a Gentleman and 2011s Do No Harm in the sense that they are all fundamentally driven forward by a thought-provoking consideration of contemporary medical issues or ethics.

In the case of Curses of Cousins, the narrative is wrapped around an exploration of intermarriage between cousins.

It is a practice that goes on not only in certain communities within the Bahamas but around the world, including the UK. While perfectly legal, it is a semi-taboo subject within society, hardly spoken of.

The problem is that this practice also carries with it a serious risk of genetic defects in any resulting offspring. Indeed, it is believed that two children born from such unions die in the UK from resultant genetic abnormalities every single week.

In the novel, the protagonist, teacher Brooklyn Watts, sets out to find out why her family, and many other families on the fictional Bahamian island of Sigatoo, suffer chronic, incurable illnesses.

In her case, it is alopecia and multiple sclerosis (MS), and, as she quickly comes to learn, her and others ill-health, previously attributed to a curse, is in fact a direct result of the traditional island practice of cousin marriage.

Despite the pain she suffers daily from her debilitating condition, she sets out on a quest to educate the population about the risks that such marriages carry to the next generation.

For Dr Bacchus, who was named Physician of the Year by the Government of the Bahamas in 2000, it is a vitally-important health issue to address.

I got the idea for Curses of Cousins as I have had several patients with genetic-based conditions that resulted from intermarriage between cousins, he says.

Im not calling for the practice to be banned outright, but there needs to be an open acknowledgment that children of such marriages run a significant risk of inheriting genetic defects that could impact their quality of life.

With this awareness then, at least, those who still wish to enter into such relationships can understand the importance of carrying out genetic counselling and blood tests to ensure a healthy progeny.

The novel is also notable for another battle that Brooklyn must face while trying to confront ignorance, superstition, and traditionalism within her society: a war between the literal forces of good and evil for control of her mind.

I always include a metaphysical aspect to my novels, explains Dr Bacchus who, in additional to a medical degree and membership of the American Association of Family Physicians and the American Association of Anti-Aging Medicine, holds a degree in metaphysical science and is the Worshipful Master of his islands Masonic lodge.

I do believe that beyond the physical we are all attuned to a higher, cosmic consciousness.

In Curses of Cousins this war between the personifications of good and evil adds a deeper level to the readers understanding of Brooklyn, and also another perspective on the obstacles she must overcome from certain parts of society in bringing about positive change.

As well as praising his latest novel for its originality and daring to broach the pressing issue of cousin marriage, reviewers have also highlighted Dr Bacchuss realistic depiction of a female lead a rare achievement for a male author.

This, however, is something that he attributes as much to his environment as his writing skills.

He says: All my life Ive been in the company of women. My children were all girls and in all my years of practice I have worked alongside female nurses.

Its given me a better understanding of the female mind than most men, I think, and it is wonderful that readers and reviewers concur.

Brooklyn was a fascinating character to create, being independently-minded, courageous and determined to protect future generations so that they wouldnt suffer in the same way that she does.

Some readers have called her inspirational, and that makes the whole writing process more than worthwhile.

I always intended to highlight the issue of intermarriage through fiction because it stands a much better chance of reaching the widest audience, compared to a dusty old academic paper that will never be read by anyone save other doctors.

But a novel stands or falls on whether the central character engages with readers, so it looks like all those years in almost exclusively female company has paid off.

As to the future, Dr Bacchus is already working on his next novel, which will be focused on another global issue world poverty.

Writing keeps my young, he adds. Its far more relaxing the medicine while also providing the opportunity to communicate with the world.

Curses of Cousins by Cliff Bacchus is out now on Amazon , priced 9.07 in paperback and 3.02 as an eBook.

EXCLUSIVE INTERVIEW WITH DR CLIFF BACCHUS

Dr Cliff Bacchus discusses his new novel, psychological thriller Curses of Cousins, and what motivates him as an author.

Q. What was your motivation for becoming an author?

A. To expand my outreach to people around the world.

Q. Your latest novel deals with a very grave subject: the risk of genetic abnormalities from intermarriage. Why did you feel it better to cover this subject through fiction than nonfiction?

A. Through fiction, I can reach more people, and generate more interest through theme, plot structure, unique characterisation, and suspense.

Q. What do you hope readers get from reading your new novel, Curses of Cousins?

A. I want them to grasp the theme: that cousins marrying cousins may not be the best for the children you give birth to. However, this is not a concrete rule. There are many who intermarry because of custom and religion, but it is time to reflect on the subject. If it works for you, fine! It is my point of view, based on experience as a medical doctor for nearly five decades.

Q. How did you get the idea for your latest novel?

A. From my medical experience over many decades.

Q. Describe a typical day in your life

A. I rise early, write for two hours until clinic time, 8 am to 11 am. Then its clinic again from 3 pm to 5 pm, followed by a walk and watching BBC news, CNN and talk shows, or a spot of painting on canvas. Bedtime is by 12 midnight.

Who are your literary inspirations, and why?

A. Shakespeare, Jane Austin, and Sidney Sheldon. Inspirational!

Q. All your novels include a metaphysical element. Can you explain why you feel it important to weave this into your stories?

A. Metaphysics deals with abstract concepts such as being, knowing, identity, time, and space. My novels are just about that. My novels must have meaning!

Q. If you could offer one piece of advice to somebody wanting to become an author, what would it be?

A. Be prepare to work hard and love it. Be prepared to accept the lonely life and love it. Be prepared to do research and love it.

Q. What satisfaction does writing bring you?

A. Knowing that I can communicate the truth and hope for the acceptance of it.

What can readers expect next from you?

A. Another work of fiction as I hone the craft for better and better.

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Writing is the best medicine - The London Economic

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Misleading glyphosate-cancer study Part 2: ‘Symptom of a widespread problem’Concerns about ideological activism in science research and communications…

Thursday, February 11th, 2021

For the better part of five years, a coalition of environmental groups and tort lawyers (aided by the mainstream press) has relentlessly asserted that the weedkiller glyphosate poses a serious cancer risk. A team of respected epidemiologists poured gasoline on this already raging fire in 2018, when they published a meta-analysis (which Ill refer to as the Zhang paper after the first author) that found a significant association between glyphosate exposure and the risk of non-Hodgkins lymphoma (NHL).

In part one of this series, I detailed how the authors of what appeared to be an important paper made some highly questionable decisions in order to reach their conclusion, namely selecting certain data points and excluding others from the studies they considered. Despite the serious defects that I and a few other scientists pointed out soon after the paper appeared online, the papers conclusion that relatively heavy exposure to glyphosate was associated with a 41 percent increased risk of NHL ensured that it would get widespread publicity.

But there were still other indications of bias in the paper that provide insight into the authors thinking. In this follow-up piece, I want to examine some of the other instances of bias, then address three crucial questions. How could this paper, flawed as it is, have passed peer review and largely escaped serious criticism in the two years following publication? What does the Zhang paper reveal about the authors mindset, and about standards of scholarship in the field of environmental epidemiology? And, finally, what are the implications for efforts to produce reliable science that can guide policy makers and consumers?

Well before I got to the heart of the Zhang paper, I picked up signals that put my critical antennae on guard. On page three, the authors stated, GBHs [glyphosate-based herbicides] have recently undergone a number of regional, national, and international evaluations for carcinogenicity in humans [20-23], resulting in considerable controversy regarding glyphosate and GBHs overall carcinogenic potential.

In order to support their claim of considerable controversy, the authors provided two references to agencies that found that glyphosate is not a health concern (US Environmental Protection Agency, EPA; Joint FAO/WHO Meeting on Pesticide Residues, JMPR) and two that found it to be a probable carcinogen (The International Agency for Research on Cancer, IARC; and Californias Office of Environmental Health Hazard Assessment, OEHHA), thus implying that opinion is evenly divided and balanced.

In fact, roughly a dozen national and international agencies have found glyphosate to be safe and non-carcinogenic (EPA, Health Canada, the European Food Safety Authority, the European Chemicals Authority, the UNs Food and Agriculture Organization, and the health agencies of France, Germany, Australia, New Zealand, Japan, and Brazil). The fact is that IARC is the only major agency that has found glyphosate to be problematic, and its analysis has been deemed defective by many independent experts. As for OEHHA, it mechanically follows IARC in its designation of carcinogens under Californias Proposition 65, a byzantine law approved by voters in 1986 that has led the Golden State to list garlic bread and, for a time, coffee as possible carcinogens.

Whatever controversy over glyphosate there is, then, is the product of political and legal considerations, not evidence that the weedkiller causes cancer. However, the assertion that there is considerable controversy is important to the Zhang authors because, in their telling, it is what motivated their meta-analysis, as the following sentence makes clear: Hence, addressing the question of whether or not GBHs are associated with NHL has become even more critical (emphasis mine).

Throughout the paper, there are other similarly one-sided characterizations of the evidence on specific topics.

First, in their introduction, the authors emphasized the amount of glyphosate used in the past decade and noted that it has been detected in various foods and baby formula, concluding that glyphosate may be considered ubiquitous in the environment. However, they omitted that glyphosate has relatively low acute and chronic toxicity compared to other pesticides and that the levels detected in foods are well below the level at which any adverse effects would be expected.

They observed that use of glyphosate increased roughly 16-fold between 1992 and 2009, but they failed to note that the incidence of NHL has remained unchanged over the past thirty years.

Second, they articulated criticisms of the Agricultural Health Study (AHS) at length based on secondary considerations, but failed to note its strengths. The AHS is, in fact, the best epidemiological investigation of glyphosates cancer-causing potential, and it poses a significant challenge to Zhangs conclusion. It is striking that the authors failed to note the much more serious problems with the case-control studies they inappropriately combined with the AHS (Read part one for a full analysis of this issue).

Third, to supplement the results of the meta-analysis of human studies, Zhang et al. summarized the results of studies of lymphomas in mice following the administration of glyphosate, which they interpreted as providing additional evidence of the carcinogenicity of glyphosate. However, the evidence appears mixed and, where increasing trends were seen in the tumor yield with increasing doses of glyphosate, they were modest. Researchers have evaluated glyphosate rodent studies for all tumor sites and found more instances of tumor decreases with increasing glyphosate exposure levels than tumor increases.

Finally, the authors pointed to a number of biological mechanisms that may play a role in the development NHL in humans and of lymphoma in animals. While such mechanisms are worthy of study, it is generally recognized that the results of laboratory studies are less directly relevant to risk assessment than epidemiologic studies and, secondarily, animal experiments.

Thus, there is a pattern throughout the Zhang paper of what I call motivated reasoning. Rather than evaluating the evidence on its merits, the authors constructed a narrative designed to support their a priori hypothesis. In other words, their critical faculties served to imprison them in their motivated thinking, always a danger in science thatphysicist Richard Feynman addressed in his 1974 commencement address at Caltech titled Cargo Cult Science. Feynman emphasized that when you formulate a hypothesis, you must list all the observations and facts that support it, but you must also list all of the observations and facts that do not agree with it. This is the only way not to fool yourselfand, Feynman added, you are the easiest person to fool.

Given the Zhang papers unjustified assumptions and methodological flaws, how did it survive peer review? Peer review is a lottery, by which I mean the quality of the review depends very much on the individuals who perform the review, as well as the editor who oversees the review. Some reviewers are tough minded and the study author senses they miss nothing in evaluating a paper.

At the other extreme, reviewers who are less alert or less methodologically astute may feel that the authors have made a convincing case. I would argue that Zhang et al. wrote their paper with an emphasis on justifying their choices and judgments rhetorically, if not scientifically. One almost feels snowed by their arguments. And their style of argumentation appears to have been very effective. What is clear is that neither the editors nor the reviewers noticed the pattern of motivated reasoning, selective attention to facts, and unsupported assumptions that I have described.

The fact that the Zhang paper was published in Mutation Research, a publication with a broad focus on genetic toxicology, rather than in an epidemiology journal may have increased the likelihood of an inadequate review of a paper reporting on a meta-analysis of observational epidemiology studies.

The authors response to substantive criticism has been revealing. Rather than acknowledging criticism and presenting valid arguments to support their position or modifying it, they doubled down on their hypothesis and tried to divert attention from the key issues, while asserting the transparency and quality of their work. In addition, they implied that their critics must have some conflict of interest.

I will give just one example among many. In her February 2020 Forbes piece, responding after a full year to my critique published in February 2019, Lianne Sheppard, the Zhang papers senior author, wrote that cherry-picking of data to achieve particular results is never acceptable scientific practice, and in the case of our meta-analysis, this claim is not true. But, based on her a priori hypothesis, she defended her selection of the one relative risk out of five from the AHS (relative risk 1.12) that ensured a statistically significant result.

This was not the main analysis presented by the AHS researchers in their paper that was the unlagged relative risk of 0.87. And, as I made clear in part one, there are two glaring facts that should have motivated Sheppard to reconsider her choice. First, the AHS, by far the largest and most careful study, showed no support for her a priori hypothesis that the highest exposure group would show the strongest association and demonstrated this point in all five analyses! Second, as the Zhang authors themselves acknowledged, the latency period for NHL to develop is uncertain, and could be as short as two years, although their conclusion is based on the assumption that it is 20 years. Recognition of both these facts should have made the authors reconsider the justification for their analysis.

After this evasion of the science, Sheppard went on to raise further diversions, arguing that publications in the popular media are not appropriate for the serious business of evaluating risks scientifically. Only the sacred precincts of academic journalswhere my colleagues and I have recently published a thorough critique of the Zhang paper are suitable venues for such discussion. Sheppard seems unaware of the flourishing, real-time discussions of critical issues in science and medicine by the likes of Eric Topol, Peter Hotez, Vinay Prasad, and many others on Twittter. True scientists are happy to engage with an interested audience, whatever the forum.

I have devoted time to examining this paper because I believe it is symptomatic of a state of mind that is prevalent in environmental and lifestyle epidemiology. This area is challenging due to the difficulty of measuring human exposure to low-level environmental agentsoften measured at a single point in timeand gauging their long-term health effects against the background of exposures that are often orders of magnitude stronger (smoking, alcohol consumption, diet, body mass index, postmenopausal hormones, etc). Nevertheless, numerous papers continue to be published examining the association of self-reported exposures to trace levels of chemicals in urine or blood with risk of some chronic disease.

There are those working in this area who appear to feel that, in spite of the limitations of the studiesor, perhaps, because of these limitationsone has to take seriously results that are suggestive of an association. In a sense, because of the difficulty of documenting low-level exposures, scientists may feel that they have to give them the benefit of the doubt. Given the limitations of the data, the findings of such studies need to be interpreted with an allowance for the fact that the studies cant tell us what we want to know.

The science policy scholar Daniel Sarewitz has used the term trans-science to refer to the study of complex questions that cant be answered by present-day science. In the absence of definitive data, what seems to be most important to these people is their interest in the question regarding the effects of a particular chemical agent. This is how results from weak studies that appear to point to a risk can be seized on, and this is what appears to have happened in the Zhang paper. What is lacking in high-quality evidence is compensated for by ideological and moral zeal.

Researchers are keenly aware that the media, the public, and even journal editors and reviewers are sensitive to findings that appear to implicate a common exposure in chronic disease. Where strong data are lacking but the issue is one that will resonate with the public and the media, scientists know that their message will get picked up and get traction. Weve seen many examples of this in research on electromagnetic fields, endocrine disrupting chemicals and BPA, DDT and other pesticides, e-cigarettes, and many other issues.

A number of agencies and institutions have been associated with this type of motivated sciencethe International Agency for Research on Cancer (IARC) regarding glyphosate, cell phones, and other exposures; the National Institute for Environmental Health Sciences (NIEHS) regarding BPA; and the Endocrine Society regarding endocrine-disrupting chemicals generally.

In contrast to the kind of science exemplified by the Zhang paper, there are examples of sober and careful work by scientists who are trying to advance knowledge in their field by building on firm results and framing new hypotheses. This work, however, is unlikely to attract media attention.

A recent paper by Moubadder et al. has reviewed environmental exposures in relation to NHL. With regard to environmental exposures, they noted that several infectious agents have been causally linked to NHL. However, with regard to chemical exposures, they concluded that numerous studies have attempted to link NHL risk to chemical exposures, but in spite of many reported associations, causality has not been established.

Commenting on the Zhang meta-analysis, they had this to say:

A recent meta-analysis that included the 2018 Agricultural Health Study (AHS), a cohort of pesticide applicators that have been followed prospectively, and five casecontrol studies found the relative risk of NHL to increase by 41% among those highly exposed to glyphosate-based herbicides [meta-risk ratio (RR) = 1.41; 95% CI, 1.131.75; ref. 20]. However, studies on the AHS population alone, which includes 515 incident NHL cases, have consistently observed no association between reported glyphosate exposure and NHL risk, regardless of the latency period (i.e., 5-, 10-, 15-, and 20-year lag times; refs. 21, 22).

Taking a broad view of the role of environmental exposures in the etiology of NHL, Moubadder considered glyphosate specifically, but still came to the conclusion that causality has not been shown for any chemical.

In contemplating the contrast between the Moubadder paper and the Zhang paper, I was reminded of interviewing the reproductive expert Richard Sharpe about the huge amount of fruitless research that had been devoted to BPA as a cause of adverse reproductive events. In the early 1990s Sharpe had been one of the originators of the so-called environmental estrogen hypothesis and had seen it grow into a huge academic bandwagon, which he dissociated himself from. Sharpe shifted his attention to studying the effects of pharmaceuticals taken by pregnant women on the fetus and the developing child, as well as other exposures. The shift away from studying trace exposures to BPA to more significant exposures has already led to evidence of real effects.

Explaining why he went his own way, he said, I was lucky that the question that drove me was what causes these disorders? not how do EDCs [endocrine disrupting chemicals] cause these disorders? Such a simple difference, but it takes your thought processes in a very different direction.

Geoffrey Kabat is a cancer epidemiologist and the author ofGetting Risk Right: Understanding the Science of Elusive Health Risks. Find Geoffrey on Twitter@GeoKabat

Link:
Misleading glyphosate-cancer study Part 2: 'Symptom of a widespread problem'Concerns about ideological activism in science research and communications...

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The Error of Fighting a Public Health War With Medical Weapons – WIRED

Saturday, January 2nd, 2021

Heres the wild part, the most 2020 thing about 2020: That schismthat conflict between public health and private well-being, between personal liberties and communal gainis as old as pandemics. The germ of the idea was, in fact, the idea of the germ.

In the mid-1800s, physicians and scientists were starting to come around to the long-gestating idea that diseases could be caused by wee, invisible critters that jumped from person to persona contagium animatum, as 16th-century thinkers put it. They didnt know what viruses or bacteria were, but they knew something was carrying illness.

The contagionists had their opposite number: scientists who in 1948 the researcher Edwin Ackerknecht famously called anticontagionists. Oh, they believed that some diseases spread by some agent, person-to-person. Smallpox and syphilis, maybe. Those were contagious. But they werent epidemicsyellow fever, cholera, or the plague, things that seemed to spread seasonally, or in specific places, or only among specific kinds of people. Nobody knew how. They didnt know anything about food- and waterborne pathogens, about differences between viruses and bacteria, about surface-borne fomites that transmitted disease in some cases, while exhaled droplets and aerosols might in others. Absent any of that? Well, maybe it was something atmospherica cloud of illness, a miasma, maybe even the filth of poverty and pre-sanitation cities. (Its telling that scientists are still fighting over the idea of an airborne contagium animatum, even today.)

But the anticontagionists knew one thing for sure. Those big three epidemicswith typhus thrown in sometimes, toowere the things that had, since the 14th century, caused governments to take population-scale measures to control them. That meant quarantines, travel restrictions, business closureswhat today we might call lockdowns. And that made the anticontagionists nuts. They said that lockdowns, then as now, were bad for business; losses incurred as a result outweighed those caused by the epidemic itself. In the midst of the 19th centurys Industrial Revolution, anything that inhibited business was an inhibition of freedom itself. Quarantines meant, to the rapidly growing class of merchants and industrialists, a source of losses, a limitation to expansion, a weapon of bureaucratic control that it was no longer willing to tolerate, Ackerknecht wrote. Contagionism would, through its associations with the old bureaucratic powers, be suspect to all liberals, trying to reduce state interference to a minimum. Anticontagionists were thus not simply scientists, they were reformers, fighting for the freedom of the individual and commerce against the shackles of despotism.

Also, by saying that disease came from lack of sanitation and poor hygiene, the pro-filth contingent was sometimes quietly and sometimes loudly associating disease with ethnicity and socioeconomic status. It was immunological social Darwinism; if poor and nonwhite people got sick first, or more often, that proved to some reformers that those people made bad personal choices (rather than indicating a failure of the systems around them). In that light, identifying filth as the generator of epidemics paved the way for the hygiene movement, showed the moral and physical superiority of unpoor whites, and provided a rationale for slum clearance and residential zoning laws. Squint at redlining and you see not just the geography of racism but also a colonial cordon sanitaire.

To be fair, as one historian notes, the (paltry) science of miasmas did suggest that quarantines would actually make epidemic diseases worse, because they amplified the confinement and lousy conditions that spread the disease. And if you read miasma as the conditions that make a disease spread, well, thats also the point Im trying to make, so yeah. These were good-faith scientific arguments that also happened to be politically motivated economic and philosophical ones, tinged by racism.

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The Error of Fighting a Public Health War With Medical Weapons - WIRED

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Moderna, Pfizer vaccine trials were the highest of quality: vaccine expert – Yahoo Money

Saturday, January 2nd, 2021

The Guardian

Republicans say they will reject presidential electors from states where Trump campaign contested results unless audit completedTed Cruz of Texas, Ron Johnson of Wisconsin and nine other Republican US senators or senators-elect said on Saturday they will reject presidential electors from states where Donald Trump has contested his defeat by Joe Biden, unless and until [an] emergency 10-day audit of such results is completed.The move is largely symbolic and unlikely to overturn the presidential election. Nonetheless, it adds to a sense of deepening crisis affecting US democracy.Trump has refused to concede, though Biden won more than 7m more votes nationally and took the electoral college by 306-232, a margin Trump called a landslide when he won it over Hillary Clinton in 2016.The Trump campaign has lost the vast majority of more than 50 lawsuits it has mounted in battleground states, alleging electoral fraud, and before the supreme court.On Friday, a federal judge dismissed a suit lodged by a House Republican which attempted to give the vice-president, Mike Pence, who will preside over the certification of the electoral college result on Wednesday, the power to overturn it.Nonetheless, the senators and senators-elect who issued a statement on Saturday followed Senator Josh Hawley of Missouri in committing to challenging the result.Objections are also expected from a majority of House Republicans. Objections must be debated and voted on but as Democrats control the House and the Senate majority leader, Mitch McConnell, and other senior Republicans have voiced opposition, the attempt to disenfranchise a majority of Americans seems doomed to fail.On Saturday, Senator Lisa Murkowski of Alaska said she would vote to certify the results, writing: The oath I took at my swearing-in was to support and defend the constitution of the United States, and that is exactly what I will do. Pat Toomey of Pennsylvania, a state where Trump has sued, said he would vigorously defend our form of government by opposing this effort to disenfranchise millions of voters in my state and others.But Cruz and Johnson were joined by Senators James Lankford (Oklahoma), Steve Daines (Montana), John Kennedy (Louisiana), Marsha Blackburn (Tennessee) and Mike Braun (Indiana). Senators-elect Cynthia Lummis (Wyoming), Roger Marshall (Kansas), Bill Hagerty (Tennessee) and Tommy Tuberville (Alabama) also signed on.The election of 2020, they said, like the election of 2016, was hard fought and, in many swing states, narrowly decided. The 2020 election, however, featured unprecedented allegations of voter fraud, violations and lax enforcement of election law, and other voting irregularities.No hard evidence for such claims has been presented. Federal officials including former attorney general William Barr and Christopher Krebs, a cyber security chief fired by Trump, have said the election was secure.Regardless, the senators said Congress should immediately appoint an electoral commission, with full investigatory and fact-finding authority, to conduct an emergency 10-day audit of the election returns in the disputed states. Once completed, individual states would evaluate the commissions findings and could convene a special legislative session to certify a change in their vote, if needed.The senators made reference to the contested election of 1876, which ended in the appointment of such a commission.We should follow that precedent, they said. Most well-informed observers would suggest otherwise, given that process put an end to post-civil war Reconstruction and led to the institution of racist Jim Crow laws across the formerly slave-owning south.In August, the Pulitzer-winning historian Eric Foner told the Guardian: The election of 1876 would not have been disputed at all if there hadnt been massive violence in the south to prevent black people from voting and voter suppression like we have today. Now, voter suppression is mostly legal.Presciently, given baseless claims that voting under a pandemic was abused by Democrats, he added: Today, I can certainly see the Trump people challenging these mail-in ballots: Theyre all fraudulent, they shouldnt be counted. Challenging peoples voting.Cruz, like Hawley, is prominent among Republicans expected to run for president in 2024, and thus eager to appeal to supporters loyal to Trump. On Saturday, Christine Pelosi, daughter of House speaker Nancy Pelosi and a member of the Democratic National Committee, referred to the bitter 2016 primary when she tweeted: Ted Cruz is defending Trumps assaults on democracy with more energy than he defended his own family against Trumps assaults on his wife and father.The Democratic strategist Max Burns wrote: The exact same Senate GOP that refused to allow a single witness during President Trumps impeachment trial now wants to call a bunch of witnesses to investigate Joe Bidens 2020 victory.Biden did not immediately comment. In Congress, the Connecticut senator Richard Blumenthal branded the statement pathetic, un-American and an attack on our democracy. Amy Klobuchar, from Minnesota, said Biden will be inaugurated on 20 January, and no publicity stunt will change that.Trump did not immediately comment but his campaign tweeted: THANK YOU! The Arizona congressman Paul Gosar hailed the senators as patriots.But there was also criticism from the right. Joe Walsh, a former congressman who ran against Trump in 2020, wrote: They cite ZERO evidence of voter fraud Donald Trumps single greatest legacy is the destruction of truth.Walsh added: These Republicans know this is bad for the country. But they dont care. They believe its good for them politically. They are placing their own interests before the countrys interests.With unintended irony or simple bad faith the senators and senators-elect said their allegations are not believed just by one individual candidate. Instead, they are widespread. Reuters/Ipsos polling, tragically, shows 39% of Americans believe the election was rigged. That belief is held by Republicans (67%), Democrats (17%), and Independents (31%). Whether or not our elected officials or journalists believe it, that deep distrust of our democratic processes will not magically disappear. It should concern us all. And it poses an ongoing threat to the legitimacy of any subsequent administrations.Marc Elias, a leading Democratic elections lawyer, said of the senators: History will remember and curse them for their cowardice and treachery.

Read more here:
Moderna, Pfizer vaccine trials were the highest of quality: vaccine expert - Yahoo Money

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Celebrate the new year with this New Year’s Eve fireworks show in SF – Yahoo News

Saturday, January 2nd, 2021

The Telegraph

Donald Trump was dealt a stinging rebuke by Republican senators last night as Congress overrode his veto of a sweeping defence bill. It was the first time in Mr Trump's four years as president that Congress had blocked his veto power. Many Republican senators joined Democrats in an 81-13 vote to override, well over the two thirds majority required. As a result the annual $740 billion National Defense Authorization Act to fund the military in 2021 will become law. Mr Trump had called the result, which was expected, a "disgraceful act of cowardice" and the Republican leadership in Congress "weak". The bill will provide a three per cent pay raise for US troops and included elements relating to defence policy, troop levels, weapons systems and military construction. Mr Trump had vetoed it, arguing it allowed for the renaming of military bases that honour Confederate generals, and that it limited his ability to bring troops home from Afghanistan and Germany. He also tried to link passage of the bill to measures targeting social media companies. Throughout Mr Trump's term Republican senators had been highly reluctant to break so publicly with him. He had vetoed eight previous bills and none were overridden. But with less than three weeks left in office Mr Trump's influence with Republican senators appeared to have receded markedly. Mitch McConnell, the Republican leader in the Senate, said: "It's time for us to deliver this bill. It's our chance to remind brave service members and their families that we have their backs." It came as Republicans also faced a deepening split over Mr Trump's last ditch attempt to overturn the US presidential election result. Over 140 Republicans in the House of Representatives may be ready to back a move not to certify the outcome at a joint session of Congress on Jan 6, it emerged. But even with that level of support the attempt to block the result still had no chance of success. Mr McConnell privately urged colleagues to accept the election result, and called his own vote on Jan 6 the "most consequential I have ever cast". In an open letter Ben Sasse, the Republican senator from Nebraska, accused colleagues of "playing with fire". He said: "Lets be clear what is happening here. We have a bunch of ambitious politicians who think theres a quick way to tap into the presidents populist base without doing any real, long-term damage. But theyre wrong. "Adults dont point a loaded gun at the heart of legitimate self-government." The move to oppose the election results was ignited by Josh Hawley, a Republican senator from Missouri. He will object, forcing a two-hour debate, followed by a vote in the Senate, and in the House of Representatives. The session in Congress will take place a day after two run-off races in Georgia, which will determine whether Republicans or Democrats control the Senate. David Perdue, one of two Republican candidates, announced he would spend the final days of the campaign in quarantine after possible exposure to the coronavirus. Meanwhile, it emerged that staffing changes were to be made to the Secret Service's presidential detail when Joe Biden takes office on Jan 20. Mr Biden's camp was said to have expressed concerns that current agents might be politically supportive of Mr Trump. Mr Trump cut short a trip to Florida and headed back to Washington on New Year's Eve. In a New Year video message he hailed "historic victories" on the economy and fighting the pandemic. He said: "We have to be remembered for what's been done." In the final weeks of his term the president was also facing an ongoing battle with Republicans in Congress, including Mr McConnell, after he called for an increase in stimulus cheques to Americans. He also faced growing friction with Iran.

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Celebrate the new year with this New Year's Eve fireworks show in SF - Yahoo News

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The movie industry will strengthen again around April or May: Screenvision CEO – Yahoo Money

Saturday, January 2nd, 2021

The Guardian

Republicans say they will reject presidential electors from states where Trump campaign contested results unless audit completedTed Cruz of Texas, Ron Johnson of Wisconsin and nine other Republican US senators or senators-elect said on Saturday they will reject presidential electors from states where Donald Trump has contested his defeat by Joe Biden, unless and until [an] emergency 10-day audit of such results is completed.The move is largely symbolic and unlikely to overturn the presidential election. Nonetheless, it adds to a sense of deepening crisis affecting US democracy.Trump has refused to concede, though Biden won more than 7m more votes nationally and took the electoral college by 306-232, a margin Trump called a landslide when he won it over Hillary Clinton in 2016.The Trump campaign has lost the vast majority of more than 50 lawsuits it has mounted in battleground states, alleging electoral fraud, and before the supreme court.On Friday, a federal judge dismissed a suit lodged by a House Republican which attempted to give the vice-president, Mike Pence, who will preside over the certification of the electoral college result on Wednesday, the power to overturn it.Nonetheless, the senators and senators-elect who issued a statement on Saturday followed Senator Josh Hawley of Missouri in committing to challenging the result.Objections are also expected from a majority of House Republicans. Objections must be debated and voted on but as Democrats control the House and the Senate majority leader, Mitch McConnell, and other senior Republicans have voiced opposition, the attempt to disenfranchise a majority of Americans seems doomed to fail.On Saturday, Senator Lisa Murkowski of Alaska said she would vote to certify the results, writing: The oath I took at my swearing-in was to support and defend the constitution of the United States, and that is exactly what I will do. Pat Toomey of Pennsylvania, a state where Trump has sued, said he would vigorously defend our form of government by opposing this effort to disenfranchise millions of voters in my state and others.But Cruz and Johnson were joined by Senators James Lankford (Oklahoma), Steve Daines (Montana), John Kennedy (Louisiana), Marsha Blackburn (Tennessee) and Mike Braun (Indiana). Senators-elect Cynthia Lummis (Wyoming), Roger Marshall (Kansas), Bill Hagerty (Tennessee) and Tommy Tuberville (Alabama) also signed on.The election of 2020, they said, like the election of 2016, was hard fought and, in many swing states, narrowly decided. The 2020 election, however, featured unprecedented allegations of voter fraud, violations and lax enforcement of election law, and other voting irregularities.No hard evidence for such claims has been presented. Federal officials including former attorney general William Barr and Christopher Krebs, a cyber security chief fired by Trump, have said the election was secure.Regardless, the senators said Congress should immediately appoint an electoral commission, with full investigatory and fact-finding authority, to conduct an emergency 10-day audit of the election returns in the disputed states. Once completed, individual states would evaluate the commissions findings and could convene a special legislative session to certify a change in their vote, if needed.The senators made reference to the contested election of 1876, which ended in the appointment of such a commission.We should follow that precedent, they said. Most well-informed observers would suggest otherwise, given that process put an end to post-civil war Reconstruction and led to the institution of racist Jim Crow laws across the formerly slave-owning south.In August, the Pulitzer-winning historian Eric Foner told the Guardian: The election of 1876 would not have been disputed at all if there hadnt been massive violence in the south to prevent black people from voting and voter suppression like we have today. Now, voter suppression is mostly legal.Presciently, given baseless claims that voting under a pandemic was abused by Democrats, he added: Today, I can certainly see the Trump people challenging these mail-in ballots: Theyre all fraudulent, they shouldnt be counted. Challenging peoples voting.Cruz, like Hawley, is prominent among Republicans expected to run for president in 2024, and thus eager to appeal to supporters loyal to Trump. On Saturday, Christine Pelosi, daughter of House speaker Nancy Pelosi and a member of the Democratic National Committee, referred to the bitter 2016 primary when she tweeted: Ted Cruz is defending Trumps assaults on democracy with more energy than he defended his own family against Trumps assaults on his wife and father.The Democratic strategist Max Burns wrote: The exact same Senate GOP that refused to allow a single witness during President Trumps impeachment trial now wants to call a bunch of witnesses to investigate Joe Bidens 2020 victory.Biden did not immediately comment. In Congress, the Connecticut senator Richard Blumenthal branded the statement pathetic, un-American and an attack on our democracy. Amy Klobuchar, from Minnesota, said Biden will be inaugurated on 20 January, and no publicity stunt will change that.Trump did not immediately comment but his campaign tweeted: THANK YOU! The Arizona congressman Paul Gosar hailed the senators as patriots.But there was also criticism from the right. Joe Walsh, a former congressman who ran against Trump in 2020, wrote: They cite ZERO evidence of voter fraud Donald Trumps single greatest legacy is the destruction of truth.Walsh added: These Republicans know this is bad for the country. But they dont care. They believe its good for them politically. They are placing their own interests before the countrys interests.With unintended irony or simple bad faith the senators and senators-elect said their allegations are not believed just by one individual candidate. Instead, they are widespread. Reuters/Ipsos polling, tragically, shows 39% of Americans believe the election was rigged. That belief is held by Republicans (67%), Democrats (17%), and Independents (31%). Whether or not our elected officials or journalists believe it, that deep distrust of our democratic processes will not magically disappear. It should concern us all. And it poses an ongoing threat to the legitimacy of any subsequent administrations.Marc Elias, a leading Democratic elections lawyer, said of the senators: History will remember and curse them for their cowardice and treachery.

Original post:
The movie industry will strengthen again around April or May: Screenvision CEO - Yahoo Money

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Congress overrides Donald Trump’s veto of a defense policy bill in the first such rebuke of his presidency – Yahoo News

Saturday, January 2nd, 2021

The Telegraph

Donald Trump was dealt a stinging rebuke by Republican senators last night as Congress overrode his veto of a sweeping defence bill. It was the first time in Mr Trump's four years as president that Congress had blocked his veto power. Many Republican senators joined Democrats in an 81-13 vote to override, well over the two thirds majority required. As a result the annual $740 billion National Defense Authorization Act to fund the military in 2021 will become law. Mr Trump had called the result, which was expected, a "disgraceful act of cowardice" and the Republican leadership in Congress "weak". The bill will provide a three per cent pay raise for US troops and included elements relating to defence policy, troop levels, weapons systems and military construction. Mr Trump had vetoed it, arguing it allowed for the renaming of military bases that honour Confederate generals, and that it limited his ability to bring troops home from Afghanistan and Germany. He also tried to link passage of the bill to measures targeting social media companies. Throughout Mr Trump's term Republican senators had been highly reluctant to break so publicly with him. He had vetoed eight previous bills and none were overridden. But with less than three weeks left in office Mr Trump's influence with Republican senators appeared to have receded markedly. Mitch McConnell, the Republican leader in the Senate, said: "It's time for us to deliver this bill. It's our chance to remind brave service members and their families that we have their backs." It came as Republicans also faced a deepening split over Mr Trump's last ditch attempt to overturn the US presidential election result. Over 140 Republicans in the House of Representatives may be ready to back a move not to certify the outcome at a joint session of Congress on Jan 6, it emerged. But even with that level of support the attempt to block the result still had no chance of success. Mr McConnell privately urged colleagues to accept the election result, and called his own vote on Jan 6 the "most consequential I have ever cast". In an open letter Ben Sasse, the Republican senator from Nebraska, accused colleagues of "playing with fire". He said: "Lets be clear what is happening here. We have a bunch of ambitious politicians who think theres a quick way to tap into the presidents populist base without doing any real, long-term damage. But theyre wrong. "Adults dont point a loaded gun at the heart of legitimate self-government." The move to oppose the election results was ignited by Josh Hawley, a Republican senator from Missouri. He will object, forcing a two-hour debate, followed by a vote in the Senate, and in the House of Representatives. The session in Congress will take place a day after two run-off races in Georgia, which will determine whether Republicans or Democrats control the Senate. David Perdue, one of two Republican candidates, announced he would spend the final days of the campaign in quarantine after possible exposure to the coronavirus. Meanwhile, it emerged that staffing changes were to be made to the Secret Service's presidential detail when Joe Biden takes office on Jan 20. Mr Biden's camp was said to have expressed concerns that current agents might be politically supportive of Mr Trump. Mr Trump cut short a trip to Florida and headed back to Washington on New Year's Eve. In a New Year video message he hailed "historic victories" on the economy and fighting the pandemic. He said: "We have to be remembered for what's been done." In the final weeks of his term the president was also facing an ongoing battle with Republicans in Congress, including Mr McConnell, after he called for an increase in stimulus cheques to Americans. He also faced growing friction with Iran.

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Congress overrides Donald Trump's veto of a defense policy bill in the first such rebuke of his presidency - Yahoo News

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How the pandemic enabled a robot revolution – Politico

Friday, December 4th, 2020

Future Pulse is a new weekly newsletter exploring the rapidly changing world of health care and technology. We call out fads from real advances, chronicle experimentation and investigate the tension between innovation, regulation and privacy. Join the conversation!

JUST WHAT THE ROBOT ORDERED: At several Texas health networks, a friendly-looking robot with a mechanical arm and blinking lights for eyes can be seen whirring around the hospital floor, ferrying lab samples and protective gear for nursing staff. At Bostons Brigham & Womens this summer, a roaming four-legged robot with mounted infrared cameras loped into the emergency department to take patients vital signs. At Los Angeles Adventist Health White Memorial, seven devices the size of mini-fridges zip around to disinfect patient rooms with UV light.

Whether theyre restocking supply rooms or taking patients heart rates, the roving machines could help contain the coronavirus spread by cutting down on possible exposure between staff and patients, health system leaders say. The systems were already in the early stages of piloting robots before the pandemic, but the crisis has generated more interest than ever, robotics experts tell us. The big question is whether to rush to automate is pushing aside viable existing technologies

What were trying to do is introduce ways of really preserving safety of health care personnel by having assistance ... in doing tasks that can essentially be handed off to a robot, says MIT assistant professor Giovanni Traverso, part of the research team that sent Boston Dynamics dog-like robot named Spot into Brigham & Womens exam rooms to measure vital signs like temperature and blood pressure.

Rich Pedroncelli/AP Photo

Stopped at the door: Still, there are lots of mundane challenges some robots havent been able to overcome, like walking up stairs or opening certain types of doors. For robots in general, the standard doorknob is still going to be most challenging, says Andrew Rossi of Diligent Robotics, which created the Moxi robot used in the Texas health systems.

And anytime the robots are deployed to a new health system, they have to be programmed with new instructions. We have to understand what elevators they use and how they badge in and out of doors and then we have to make adjustments, Rossi said.

Theres much to learn before health systems go all in with robots, MITs Traverso said. His team is exploring whether Boston Dynamics Spot, which retails for about $75,000, is worth the investment. Theyre also considering patients comfort levels with the robot caregivers, which Traverso admits might be a little jarring. In general, though,people are curious and kind of fascinated by this robot, he says.

A simpler approach?: And the biggest question remains is the high-tech way ultimately the better way?

I think we need to further expand our understanding and exposure to robots and see them in different settings, Traverso says. The main question is, do we need that level of sophistication, or are there simpler systems?

Welcome back to Future Pulse, where we explore the convergence of health care and technology. Share your news and feedback: @dariustahir, @ravindranize, @ali_lev, @katymurphy.

Next week, POLITICO will feature a special edition Future Pulse newsletter at the Milken Institute Future of Health Summit. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators determined to confront and conquer the most significant health challenges. Covid-19 has exposed weaknesses across our health systems, particularly in the treatment of our most vulnerable communities, driving the focus of the 2020 conference on the converging crises of public health, economic insecurity, and social justice.

Michael Anne Kyle @michaelannica "Being in year 5 of a PhD in health policy, I have spent a very large amount of time thinking about waste, moral hazard, unnecessary utilization, consumer decision-making, etc. And yet this week I went to the ED for a broken toe."

The percentage of telehealth visits for mental health services rose in most regions this year, possibly due to increased stress, FAIR Health's president Robin Gelburd says. Variation could be due to differences in substance use disorder diagnoses.

A periodic feature delivering insights from health and tech leaders on how the pandemic is changing the medical system.

Its been less than a year since Chinese scientists shared the Covid-19 genetic sequence, allowing the sprint for a vaccine to commence. Now, states have until the end of this week to tell the federal government how they plan to distribute shots that could be shipped within 24 hours of FDA authorization.

Experts told us they have a multitude of concerns over how the vaccines are allocated to states, wholl get the shots first, and misinformation spreading online.

This is the first time in the history of our country where we are launching multiple novel vaccines all at once that have different dosing, complex scheduling and challenging transport, storage and administration requirements, says Vivian Riefberg, former co-lead of McKinseys U.S. health care practice and now professor of practice at University of Virginias Darden School of Business. Combine this with at least 50 different high level distribution plans (each state) using a range of inexperienced and experienced health care professionals in delivering these products. Then add to that overall market confusion for consumers about the various products. Will we have the right coordinated logistics and campaign to ensure the vast majority of people have timely access and take the vaccine?

David Blumenthal, president of the Commonwealth Fund, which has studied states immunization track records, said his big concern is that many states may not have the resources they need to implement an emergency population-wide immunization plan. Commonwealths research, he said, found huge variation across states in their past success in vaccinating their populations against influenza and other infectious diseases. States also display considerable differences in their ability to immunize populations of color, who suffer disproportionately from Covid-19.

We should leverage primary care providers, who have built trusting relationships with their patients, to educate the public and administer vaccines, says Farzad Mostashari, CEO of Aledade and a former national coordinator for health IT in the Obama administration. As front line workers, they should also be prioritized to receive the vaccines themselves. My biggest concern is that distribution may leave out smaller independent practices, especially in rural and underserved areas where their participation is needed most.

Im less concerned about the nuts and bolts of physical distribution, says Robert Wachter, professor and chair of the Department of Medicine at University of California, San Francisco. Im more concerned about misinformation about side effects ... When you vaccinate 200 million people, a fair number of them will have strokes, cancer or heart attacks in the months after vaccination. Some will spin these into vaccine side effects.

Paul Barrett, deputy director of the NYU Stern Center for Business and Human Rights, worries that the drumbeat of false information online will discourage vaccination. Even before Covid-19, a loud chorus of anti-vaxxer activists, some of whom wrapped their views in various conspiracy theories, had become prominent on the major social media platforms, he said. The coming Covid-vaccination push will almost certainly provoke this contingent into redoubling their activities.

GOOGLES LATEST BID FOR HOSPITAL AND PATIENT DATA: The tech giants forays into health care havent always been welcomed: Its data-collection partnership with the hospital chain Ascension is still under HHS investigation for potential violations of the health privacy law HIPAA. But POLITICO's Mohana Ravindranath writes Googles cloud business is now marketing itself as a technical facilitator for hospitals and insurers, as part of the broader push to share patient data between electronic health records and apps.

Google executives say the effort can relieve hospitals and insurers from the burden of doing a huge technical undertaking on their own. Beyond that, the company is prodding the industry to think bigger about how the digital overhaul can improve patient care, said Google Clouds global health care director Aashima Gupta. This could include new ways to analyze clinical data or building apps that could help patients manage their condition.

Patients may want better access to their health data, but its not clear if theyll trust this latest venture to safeguard theirs. Asked whether shes seen pushback from providers wary of Silicon Valleys expansion into health care, Gupta stressed the company aimed to be sensitive to the needs of clinicians and patients alike. "Consumers are demanding better ways to access their data," she said.

THE PROMISE AND PITFALLS OF AI: Artificial intelligence has been eyed as an easy fix for a health care system facing strain from the pandemic, an aging population and rising costs. Still, the technology raises ethical, legal, economic, and social questions policymakers must confront in order to realize its full potential, concludes a new report to Congress.

Jacquelyn Martin/AP Photo

The Government Accountability Office and the National Academy of Medicine in a joint inquiry acknowledge that AI has shown promise in predicting health outcomes, recommending treatment and helping to record clinical notes, among other tasks. But significant challenges persist. For instance, the technical experts building these tools cant always rely on high-quality data, potentially perpetuating bias that affects patient care. And how these systems work arent always transparent to patients or clinicians, which can undermine trust.

Given those trade-offs, the report offers six paths for Congress and federal regulators to consider, though it offers no recommendations. These include allowing the technology to flourish without government intervention (though GAO noted this could also increase disparities) and working with outside groups to encourage better data sharing and AI testing. Authors noted that groups with proprietary data and technology might be reluctant to participate.

TRUMP ADMIN CEMENTS VIRTUAL CARE CHANGES: The federal Medicare agency on Tuesday approved expanded coverage of telehealth services, ensuring some pandemic policies will last beyond the public health emergency period. Medicare will pay for 60 more telehealth services, though the changes wont do much for patients outside rural areas when the emergency declaration is lifted. Medicare payment law generally restricts telehealth coverage to patients in rural areas, unless Congress makes a change.

Alcoholics Anonymous goes to Zoom, reports the New York Times.

Science Magazine probes HHSs controversial coronavirus data system, alleges discrepancies.

STAT delves into a new artificial intelligence feat from the folks at Google DeepMind: folding proteins.

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How the pandemic enabled a robot revolution - Politico

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The mink link: How COVID-19 mutations in animals affect human health and vaccine effectiveness – The Conversation CA

Tuesday, November 24th, 2020

The importance of commercially raised animals in the COVID-19 pandemic has received much attention in the past few weeks, when a new variant of SARS-CoV-2 was detected in farmed mink. Unfortunately, mink tend to be relatively susceptible to respiratory infections, and these can readily spread through mink farms due to high-density housing.

Data from the Netherlands earlier in the pandemic have revealed that mink can be readily infected with SARS-CoV-2 and then pass the virus to humans. In Denmark, 214 people people have been infected by a variant of SARS-CoV-2 that is presumed to have mutated in Danish mink. Over 200 mink farms had tested positive for SARS-CoV-2, and at least five different mink variants of the virus have been detected so far.

These events initiated a mass culling of farmed mink in that country (although this was limited due to legal issues), and cast a spotlight on the disturbing scenario of human-to-mink-to-human transmission of SARS-CoV-2, with potential for the virus to change in mink prior to re-infecting people.

Specifically, this latest occurrence unveils the possibility that mink can serve as an alternate host to promote mutations of SARS-CoV-2, which can be passed back to humans and other animals, both domestic and wild and potentially placing the wild mustelid (minks, ferrets and related species) population at risk.

We are researchers in the fields of virology, immunology and pathology. Our research programs bridge human and animal health and study the transmission of viruses, immune responses to viruses, how viruses cause diseases, and developing strategies such as vaccines to prevent infectious diseases. The recent news linking mink to the current pandemic highlights the importance of research at the interface of animal and human health.

Since the start of the COVID-19 pandemic, the world has learned much about virology, as well as the concept of One Health. At the core of One Health is the idea that human and animal health are intertwined in a shared environment, and that we need to broaden our perspectives beyond human health alone.

Indeed, animals have been at the centre of this pandemic from the beginning. Overwhelming evidence suggests that this coronavirus (SARS-CoV-2), which causes COVID-19, originated from bats. There is debate about whether an intermediate animal host might have harboured additional changes to SARS-CoV-2 to produce the current virus that spreads efficiently person to person. The leading candidate for this is a scaly anteater known as a pangolin.

What is known for sure is that changes to coronaviruses can occur over time due to inherent and purposeful errors in these viruses ability to copy their genetic codes. This allows a virus to make small changes over time and is an efficient way for them to adapt to new environments.

One of the recently identified Danish mink strains is particularly concerning because changes in the genome occurred in what is called the viruss spike protein, which it uses to enter human cells. These changes have been detected in 12 human cases related to this particular mink variant. Fortunately, this change does not seem to correlate with worse clinical outcomes, based on a small number of cases.

The spike protein is also the primary target of natural and vaccine-induced immune responses to the virus. In theory, if SARS-CoV-2 mutates too much, the immunity derived from the parental virus, acquired either by natural infection or vaccination, could become less effective against the new strain.

The good news is that, so far, theres no evidence that the mink-derived SARS-CoV-2 mutant can bypass natural or vaccine-induced immunity. Fortunately, our immune systems are designed to generate antibodies against multiple parts of the spike protein. This means that if only a small part of the spike protein is mutated, antibodies against other parts of the protein should still confer at least some protection.

The fact that SARS-CoV-2 can change highlights the need for vaccines that not only induce protective antibodies but that can also elicit robust T cell responses, which is the other major mechanism by which our immune systems can kill viruses. Like antibodies, T cells will target multiple parts of viral proteins, thereby increasing the chance of maintaining immunity against non-mutated regions of the proteins.

It might also be important to consider making vaccines that target more than one of the proteins from SARS-CoV-2. Its very difficult for a virus to make major changes to multiple proteins without compromising its fitness.

Read more: Training our immune systems: Why we should insist on a high-quality COVID-19 vaccine

The other issue that the mink SARS-CoV-2 brings to the forefront of the vaccine development effort is the need for vaccines that are plug-and-play. These are vaccine technologies where the viral protein the vaccine is designed to target can be readily swapped with a different version of the viral protein.

Once approved by health regulators as being safe and efficacious against a highly pathogenic coronavirus, such technologies could, in theory, be rapidly modified to target emerging mutant viruses; akin to the annual flu vaccine that gets modified every year to target emerging influenza virus variants.

With mink being confirmed only recently as a possible reservoir for SARS-CoV-2, more research is urgently needed to inform rationally based decisions to cull millions of these animals. Even if mass cullings continue, it is unlikely that mink farms will be completely phased out at the global level in the near future. So the question becomes how do we manage the potential threat to human health of SARS-CoV-2 in mink over the long term?

First, enhanced biosecurity measures should be implemented on mink farms.

Second, screening of farmed mink for coronaviruses should be added to the surveillance programs of animal health regulatory agencies, with this information made available to human health regulators.

Third, consideration could be given to tailoring COVID-19 vaccines for animal reservoirs, which would now include farmed mink. These recommendations would not only reduce the potential spread of coronaviruses from mink to humans, it would simultaneously address SARS-CoV-2-related health issues for mink. Indeed, mink can develop COVID-19 after becoming infected with SARS-CoV-2 and it can sometimes be severe and lethal, with no effective current treatment.

Unless future evidence suggests otherwise, it may be best to stay the course with current vaccine development programs with the goal of getting multiple technological platforms approved for use in humans. Then these platforms can be readily modified, akin to the annual influenza vaccine, to target emerging mutant viruses, if warranted.

Simultaneously, public health agencies with any interest in promoting human health should expand their visions to include the health and surveillance of domestic animals and wildlife at the point where human and veterinary medicine interface.

In the case of SARS-CoV-2, humans are currently the largest reservoir of the virus on Earth, and the threat of spillover from human hosts to farmed animals and wildlife species is now made evident. This is an opportune time to take stock in our relationships with animals and the natural world and take action to ensure health for all and this biosphere we share.

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The mink link: How COVID-19 mutations in animals affect human health and vaccine effectiveness - The Conversation CA

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How vaccines get made and approved in the US – The Albany Herald

Tuesday, November 24th, 2020

COVID-19 and its wide-ranging impacts on the lives of nearly everyone on the planet have brought vaccines to the forefrontif a suitable vaccine can be found and widely distributed, then life could perhaps resume some semblance of normalcy. People around the world are waiting impatiently for news of vaccine trials from companies such as Pfizer, Moderna, and AstraZeneca.

Already there have been some promising developments. On Nov. 16, Moderna released the results of a study that showed their vaccine has a 94% rate of effectiveness. While the results of their 30,000-person Phase 3 trial have not yet been published, researchers said that the results show that the vaccine is safe and effective. On Nov. 18,Pfizer and its partner BioNTech announced it concluded its Phase 3 study (which began July 27) and determined their vaccine is95% effective. Pfizer and BioNTech will submit arequest forEmergency Use Authorization by the FDA as soon as possible and plans to share their data with global regulatoryagencies.

The news from both companies has given people hope that the SARS-CoV-2 virus that causes COVID-19 can eventually be controlled. However, there is also mistrust surrounding vaccines, and often a lack of understanding about how they are created, how they are tested, and how safe they are. If people dont trust the vaccine, then people wont take it, and the pandemic could go on longer.

Some of this lack of trust comes from a lack of information or misinformation. In order to demystify vaccines and the vaccine manufacturing and approval process in the United States, Stacker consulted the Food & Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and other public health sources to better understand and explain vaccines to the general public.

After going through these authoritative health information sources, Stacker identified some key terms to help readers better understand the types of vaccines and how they work, and then listed the many steps involved in the creation, approval, and distribution of new vaccines in the U.S. We then created a list of 30 key terms and steps, showing how intensive and precise the vaccine creation and approval process is, and ultimately that vaccines are safe and effective tools for fighting disease.

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Legalization votes bring worries of increased youth marijuana use, but evidence remains murky – AberdeenNews.com

Tuesday, November 24th, 2020

One major concern of South Dakotans who opposed legalization of medical and recreational marijuana was that it could lead to an epidemic of youth use of the drug.

Drug-abuse prevention advocates and law enforcement officials said greater availability of marijuana would almost certainly lead to an increase of use among children and teens whose brains are still developing.

Despite their concerns, however, research conducted by the federal Centers for Disease Control and Prevention and the National Institutes of Health has not found an increase in the regular use of marijuana among youths in Oregon, Washington or Colorado, the states where marijuana legalization has been most extensively studied.

Colorado, for example, has a lower overall youth marijuana use rate than the U.S. as a whole. And in all three states, as in the rest of the U.S., there has been a long-term decline in the regular use of marijuana among youths.

Those statistics provide little comfort, however, for those in South Dakota who are on the front lines of the battle to prevent drug abuse by youth.

Marijuana use is associated with poorer performance in school, increased risk for mental health disorders and other negative behavior outcomes for youth, said Maureen Murray, director of mental health and prevention services at Youth and Family Services in Rapid City.

It is concerning because legalization makes people think that using marijuana is safe and doesnt have consequences, and teens dont need to hear that, Murray said. We have very significant concerns with teens.

South Dakota voters approved statewide ballots measures on Nov. 3 that have set the stage for legalization of both medicinal and recreational marijuana in July. Marijuana would be legal only for those 21 and over. South Dakota was one of four new states to legalize recreational marijuana bringing the total to 15. Medical marijuana will soon be legal in 36 states.

Regular marijuana use is defined in surveys as respondents having used the drug at least once during the 30 days before they took the survey. Research has shown that regular and heavy use of marijuana among teens carries the most risk for long-term negative effects.

National surveys such as the biennial Youth Risk Behavior Survey have shown small declines in the number of youths regularly using both marijuana and alcohol over the past decade. South Dakota has generally followed the national trend, with surveys showing a decline in regular youth marijuana use from 17.8% of youths surveyed in 2011 compared to only 16.5% in 2019.

Colorado, where recreational marijuana has been legal since 2014, also has seen declines in youth marijuana use. From 2011 to 2019, the youth use rate dropped from 22% in 2011 to 20.1% in 2019. Prevention experts say national and state education programs and prevention efforts have played a big role in declines in youth marijuana use.

Concerns over marijuana legalization among the South Dakota drug-abuse prevention community range from worries over use by motorists to the potential for women to harm children by using marijuana while pregnant or breastfeeding, said Darcy Jensen, executive director of Prairie View Prevention Services. Jensen is a licensed addiction counselor and a leader of the Coalition for a Drug Free South Dakota.

Members of the coalition met Nov. 12 to begin planning a response to marijuana legalization, Jensen said. Though reform was badly needed in how marijuana and other drug use has been treated by the criminal justice system, full legalization of marijuana was not the best way to fix those problems and may lead to new issues, Jensen said.

I dont know that this was a place that I would want South Dakota to be in, but we are, so we need to find ways to counter it, and continue to provide positive prevention education, Jensen said.

Legalizing marijuana causes new social and health problems, Jensen said, citing reports from Colorado showing that the number of traffic fatalities in which a driver tested positive for marijuana increased from 18% in 2013 to 32% in 2017.

Meanwhile, the rate of marijuana-related hospitalizations has risen sharply from an average of 1,440 per 100,000 hospitalizations annually from 2010 to 2013 to 3,517 last year. But perhaps most concerning, Jensen said, was that the number of suicide victims found to have marijuana in their bloodstreams increased.

A closer look at Colorado data reveals a nuanced, inconclusive picture of marijuana legalization. In 2018 the state Department of Public Safety published a comprehensive report on impacts of marijuana legalization. The report shows that while Colorado has seen an increase in its number of traffic fatalities, eight states with similar populations and traffic patterns that had not legalized marijuana also saw similar increases in traffic deaths. Pinning the rise in Colorado traffic deaths solely on marijuana legalization was not possible, the report said.

Furthermore, Colorados rising number of marijuana-related hospitalizations might have been influenced by changes in how hospitals track diagnoses. The healthcare industry in 2015 updated the diagnosis codes used for billing, creating many new coding categories. More codes meant doctors had more options to indicate whether they believe a patient had been using marijuana prior to being hospitalized, the 2018 Colorado public safety report said.

Suicide rates in Colorado have increased less only slightly, from 19.7% in 2012 to 20.5% in 2016. The rate of Colorado suicide victims testing positive for marijuana has nearly doubled from 11.8% in 2012 to 22.3% in 2016. Nationally, about 22.4% of suicide victims tested positive for marijuana in 2016, data that includes states where marijuana is not legal, according to a 2018 CDC report.

Still, experts studying youth marijuana use and the effects of marijuana on brain development say that South Dakotas drug-abuse prevention advocates are right to be concerned about legalization. While there does not appear to have been sharp increases in the number of children and teens using marijuana in states that have legalized, legalization remains a relatively new concept and longitudinal studies are few.

Little evidence exists to show that legalizing marijuana for medical purposes causes an increase in youth use of the drug. There also is little evidence, so far, that legalizing marijuana for recreational use leads to an increase in the overall number of children smoking or otherwise ingesting the drug. Instead, research shows adult use typically rises with legalization.

Once medical cannabis laws or medical marijuana laws are enacted, we usually see increases in use in adults ages 26 and older. But we dont see any increases in use among adolescents, which is good, said Dr. Silvia Martins, director of the Substance Use Epidemiology Unit at Columbia University. Regarding recreational legalization of cannabis, most of the research has shown that increases in use is mainly among adults.

A September 2019 report from the National Institutes of Health found that Colorado has seen no increase in the number of adolescents using marijuana since legalization for adults 21 and over in 2014. The biennial Youth Risk Behavior Survey found that in 2019, Colorados estimated rate of youth marijuana use of 20.1% was lower than the national rate of 21.7%.

An October 2019 report from the CDC found that marijuana use among students in 10th and 12th grades in Washington state did not significantly change from the year 2000 to 2016. For students in 8th grade, the regular marijuana use rate fell by half, from 12% in 2000 to 6% in 2016. In Washington, legal sales of recreational marijuana began in 2014.

Still, researchers such as Martins caution that there has not been enough research into how legalizing recreational use of marijuana affects youth drug use to draw major conclusions.

At most, researchers have only had a few years of data to study, Martins said. Most of the data on population-wide youth marijuana use come from anonymous surveys of students administered in schools such as the Youth Risk Behaviors Survey. States conduct the survey in schools during odd-numbered years, and its results are reported to the CDC. Public health officials use the survey to monitor such things as drug and alcohol abuse among adolescents.

In Colorado, there have only been two Youth Risk Behavior Surveys conducted since legal sales of recreational marijuana began, one in 2017 and one in 2019.

Another potential factor in youth marijuana use is how children growing up watching their parents and other adults use marijuana will view the drug. Parents can have a strong influence on their childrens choices, said Magdalena Cerda, director of the Center for Opioid Epidemiology and Policy at New York Universitys Grossman School of Medicine.

Previous studies have found that if your parents use drugs, then the likelihood of you using drugs is going to be higher, Cerda said. Whether that is because you think it is more acceptable, or it is because drugs are more available to you, or because of something else entirely, is relatively unclear. But I would say that is a concern.

Another 10 years could pass before the normalizing effect of legalizing marijuana shows up in surveys of high school students, she said.

Researchers have identified some troubling trends among youths who regularly use marijuana. A few studies have found increases in Cannabis Use Disorder among youths who regularly use marijuana in states that have legalized recreational sales of the drug, Cerda said. Cannabis Use Disorder is generally diagnosed when someone cant quit using despite trying, starts having trouble at work or school due to marijuana use, or gives up social activities due to use of marijuana.

That is obviously a concern because dependence on cannabis actually has an effect on your life, on your interactions with others and on your work, Cerda said. Essentially, a cannabis addiction, particularly for adolescents, can have long-term effects.

Marijuana use has been associated with an increase in a persons risk for developing a mental health disorder, said J. Cobb Scott, an assistant professor of psychology at the University of Pennsylvania Perelman School of Medicine. There also is evidence that using marijuana can lead to psychotic episodes in people who already have schizophrenia. Psychotic episodes can lead to involuntary hospitalization, homelessness or suicide, Scott said.

One significant risk of marijuana use is in youths and young adults who potentially are at risk of schizophrenia or depression, said Scott, who has spent years researching how marijuana use affects brain function and mental health.

But just because someone who has mental illness has a history of marijuana use doesnt mean the drug caused the illness, Scott said. Researchers have attempted to prove marijuana use causes mental illness but have had mixed results.

A 2019 study of how marijuana use contributed to the prevalence of psychosis in adults in Europe, published in the medical journal The Lancet, found that people using high potency marijuana every day were five times more likely to develop psychosis than people who didnt use the drug. But a 2016 study of data collected by the National Epidemiological Survey on Alcohol and Related Conditions found no link between marijuana use and mental health disorders.

Theres evidence both ways right now, Scott said. And what we dont have is a lot of epidemiological evidence. We have seen increased use of cannabis over the last 15 years or so, but we dont have the hugely increased rates of psychosis that you might expect if that relationship were really strongly causal.

Part of the difficulty in pinning down whether or not marijuana can cause psychosis is that most of the research into how marijuana affects people has been observational. Researchers have essentially had to wait for people to start using the drug on their own before marijuanas effect on them can be studied. Because researchers are not controlling who uses the drug or how much theyre using, and are often not recording their subjects medical histories or IQ levels before they start using marijuana, it can be hard to know for sure the significance of the drugs impacts.

Drawing conclusions from observational research requires large sample sizes being studied over several years, Scott said.

Some of the best evidence of marijuanas effect on brain development and mental health comes from a study conducted in New Zealand. In the study, researchers followed more than 1,000 people from the age of eight until they turned 38.

The New Zealand researchers found that subjects who developed an addiction to marijuana and began using it heavily before turning 18 and remained addicted to the drug for many years lost an average of six Intelligence Quotient points. People who started using marijuana as adults did not lose any IQ points, the study found.

An ongoing study being conducted by the U.S. National Institutes of Health, called the Adolescent Brain Cognitive Development study, should give scientists a much better understanding of how marijuana affects young brains. The study will follow more 10,000 children aged 9 and 10 for a decade. Researchers will collect information on the children using brain scans, genetic and psychological tests, academic records and surveys. The study began in 2015.

One area where there is strong evidence of marijuanas effects on people is cognitive function, or how well a persons brain works. Many studies have shown that frequent cannabis use can impact cognitive functioning in specific areas, including memory and behavior, Scott said. Marijuanas cognitive effects, though, tend to wear off fairly quickly after someone quits using the drug.

A couple of larger studies have shown that heavy use starting before the age of 18, and going on pretty consistently for a number of years, may cause long term changes in cognitive functioning. But that is a very small group of people, Scott said.

Still, South Dakotans should be concerned about marijuana use among teenagers, Scott said. There are too many unknowns about the drugs effect on brain development. Studies of rats, for example, have shown that marijuana can affect the development of important parts of the brain such as the hippocampus, which plays a significant role in learning and memory.

We know that the brain continues to develop through the teenage years and into the mid-20s, Scott said. And we know that any psychoactive substance like cannabis can potentially affect brain development.

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Your daily 6: Third vaccine looks effective, no single ‘word of the year’ and Trump team called ‘a national embarrassment’ – Ravalli Republic

Tuesday, November 24th, 2020

HARTFORD, Conn. (AP) Jury duty notices have set Nicholas Philbrook's home on edge with worries about him contracting the coronavirus and passing it on to his father-in-law, a cancer survivor with diabetes in his mid-70s who is at higher risk of developing serious complications from COVID-19.

Philbrook and his wife, Heather Schmidt, of Camarillo, California, have been trying to convince court officials that he should be excused from jury duty because her father lives with them. But court officials told him that is not a valid reason and he must appear in court early next month.

"My main concern is you still have to go into a building, you still have to be around a set number of people," said Philbrook, 39, a marketing company editor. "In an enclosed space, how safe are you? It just doesn't feel like a right time still to be doing that kind of stuff on a normal basis."

People across the country have similar concerns amid resurgences of the coronavirus, a fact that has derailed plans to resume jury trials in many courthouses for the first time since the pandemic started.

Within the past month, courts in Hartford, Connecticut, San Diego and Norfolk, Virginia, have had to delay jury selection for trials because too few people responded to jury duty summonses. The non-response rates are much higher now than they were before the pandemic, court officials say.

Judges in New York City, Indiana, Colorado and Missouri declared mistrials recently because people connected to the trials either tested positive for the virus or had symptoms.

"What the real question boils down to are people willing to show up to that court and sit in a jury trial? said Bill Raftery, a senior analyst with the National Center for State Courts. "Many courts have been responsive to jurors who have said that they're not comfortable with coming to court and doing jury duty and therefore offering deferrals simply because of concerns over COVID."

Also this month, state court systems in Connecticut, New York and New Jersey and courts in Denver, Colorado, were among those to suspend all jury trials because of rising virus rates. On Friday, federal officials announced that about two dozen U.S. district courts across the county have suspended jury trials and grand jury proceedings because of virus outbreaks and too few people showing up for jury duty.

Courts are under pressure to resume trials because of the case backlogs piling up during the pandemic.

A few courts have held trials in person and by video conference. Although video conferences may appear to be the best bet, many criminal defense lawyers oppose them because it's harder to determine witness credibility and to see if jurors are paying attention, said Christopher Adams, a lawyer in Charleston, South Carolina, and president of the National Association of Criminal Defense Lawyers.

"For almost everybody, there is no compelling need for trials to go forward during the pandemic," he said, adding that most courts are not holding jury trials at the moment.

Adams said another concern is how representative juries would be if trials went ahead the virus' impact and the level of concern about it across different demographics, such as Black, Latino and elderly populations that are dying at higher rates, could affect who feels safe to serve jury duty.

"What we can't allow is to have trials where there's not a fair cross section of the community represented," he said.

But many criminal defense lawyers are pointing to a major issue with not holding trials defendants who are detained while awaiting trial. Although jails and prisons across the country have released thousands of low-risk inmates because of concerns about the virus, many people remain locked up in pretrial detention.

A case in federal court in Hartford, Connecticut, offers a glimpse of how the virus can upend proceedings.

In October, 150 people were summoned for jury duty for the trial of Amber Foley, who is fighting child pornography charges and demanding her constitutional right to a speedy trial. It would be the first criminal trial in Connecticut, in state or federal court, since the pandemic began.

Only about half the potential jurors showed up and many others were excused for various reasons including concerns about COVID-19. Only 19 people were left, short of the 31 people estimated to be needed to pick a jury of 12 and one alternate juror.

And then, two court security officers tested positive for the virus, forcing the temporary closure of the courthouse for cleaning and prompting Judge Vanessa Bryant's law clerk to go into isolation and get tested because of contact with the officers.

Bryant decided last week to postpone Foley's jury selection until mid-January. Like judges in other parts of the country, she ruled the interests of public health outweigh those of a speedy trial.

"Despite every effort being made by the Court, the Court must reluctantly conclude that it is unable to empanel a representative jury from the 200 prospective jurors summoned without jeopardizing the safety of all trial participants," Bryant wrote in a ruling.

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Your daily 6: Third vaccine looks effective, no single 'word of the year' and Trump team called 'a national embarrassment' - Ravalli Republic

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Cybersecurity depends on the user – Modern Diplomacy

Friday, November 20th, 2020

The UN is calling for authoritative scientific information and research to be made freely available, to accelerate research into an effective vaccine against the COVID-19 virus, help counter misinformation, and unlock the full potential of science.

Arguing that no-one is safe until everyone is safe, the World Health Organization (WHO) has, for several months, been urging countries and scientists to collaborate, in a bid to bring the pandemic under control. This has involved the creation, alongside governments, scientists, foundations, the private sector and other partners, of a groundbreaking platform to accelerate the development of tests, treatments and vaccines.

In October, the head of the agency, Tedros Ghebreyesus Adhanom, alongside human rights chief Michelle Bachelet, and Audrey Azoulay, Director-General of science, culture and education agency UNESCO, issued a call for Open Science, describing it as a fundamental matter of human rights, and arguing for cutting-edge technologies and discoveries to be available for those who need them most.

But what exactly does Open Science mean, and why does the UN insist on making it more widespread?

Open Science has been described as a growing movement aimed at making the scientific process more transparent and inclusive by making scientific knowledge, methods, data and evidence freely available and accessible for everyone.

The Open Science movement has emerged from the scientific community and has rapidly spread across nations. Investors, entrepreneurs, policy makers and citizens are joining this call.

However, the agency also warns that, in the fragmented scientific and policy environment, a global understanding of the meaning, opportunities and challenges of Open Science is still missing.

Open Science facilitates scientific collaboration and the sharing of information for the benefit of science and society, creating more and better scientific knowledge, and spreading it to the wider population.

UNESCO has described Open Science as a true game changer: by making information widely available, more people can benefit from scientific and technological innovation.

Because, in a world that is more inter-connected than ever before, many of todays challenges do not respect political or geographic borders, and strong international scientific collaboration is essential to overcome the problems. The COVID-19 pandemic is a prime example.

We also have the tools to make it happen: with digitalization becoming ever more widespread, it is far easier than ever before to share scientific knowledge and data, which are needed to enable decisions that can lead to overcoming global challenges to be based on reliable evidence.

In this global health emergency, thanks to international collaboration, scientists have improved their understanding of the coronavirus with unprecedented speed and openness, embracing the principles of Open Science. Journals, universities, private labs, and data repositories have joined the movement, allowing open access to data and information: some 115,000 publications have released information related to the virus and the pandemic, and more than 80 per cent of them can be viewed, for free, by the general public.

Early in the pandemic, for example, Chinese scientists readily shared the genome of the virus, jumpstarting all following research into the virus, and the diagnostic testing, treatments, and vaccines that have since been developed.

Finally, the crisis has underlined the urgent need to bring science closer to decision making and to society as a whole. Fighting misinformation and promoting evidence-based decision-making, supported by well-informed citizens, has proven to be of vital importance in the fight against COVID 19.

To ensure that Open Science truly meets its potential, and benefits both developed and developing countries, UNESCO is taking the lead in building a global consensus on values and principles for Open Science that are relevant for every scientists and every person independently of their place of origin, gender, age or economic and social background.

The future UNESCO Recommendation on Open Science is expected to be the international instrument to set the right and just standards for Open Science globally, which fulfil the human right to science and leave no one behind.

In a statement released on World Science Day for Peace and Development, celebrated on 10 November, Ms. Azoulay said that widening the scope of Open Science will help science to unlock its full potential, making it more effective and diverse by enabling anyone to contribute, but also to bring its objectives in line with the needs of society, by developing scientific literacy in an informed citizenry who take responsibility and are involved in collective decision-making.

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