Embryology

Hundreds of patients affected by closure of IVF clinics – RTE.ie

A leading fertility specialist has said it is unlikely that IVF treatments will resume in Ireland before June.

Fertility clinics have been closed since the middle of last month leaving hundreds of patients in limbo.

Dr John Kennedy, Group Medical Director of Sims IVF, told RT's Morning Ireland that the cancellation of treatment was "awful", but that it was not possible to keep clinics open and maintain social distancing.

"You can take all the precautions with regard to Personal Protective Equipment (PPE), but it is by no means perfect and if you have a good stockpile of PPE that should probably be in the hands of the general hospitals at this point," he said.

Around 6,000 IVF cycles are undertaken every year in Ireland.

"We generally would have (egg) transfers booked four to six weeks in advance so we had a full transfer list for April.

"That's four or five transfers a day, five days a week. We are having to cancel all of them on a rolling basis so the numbers are mounting up all the time," Dr Kennedy explained.

He said Sims, like other clinics around the country, are still carrying out video consultations and responding to patient queries. However, no clinical procedures are being undertaken.

The initial decision to stop treatment came following advice from the European Society of Human Reproduction and Embryology (ESHRE) on 15 March.

The ESHRE recommendation was based on concerns over the impact of Covid-19 on early pregnancy, however, many IVF patients felt their personal choice was being taken away.

Speaking to RT's Morning Ireland, awoman, who did not want to be named, said:"We have been treated like brood mares. I feel as though my rights, my liberty has been taken away.

"I do not have autonomy over my own body, my own reproductive system. It is abhorrent."

Dr Kennedy described the timeline for reopening clinics as the "million dollar question".

"My gut is telling me nothing good is going to happen in April, it is unlikely something will happen in May, but certainly after that if all the clinics are still closed really everything is going to start to struggle an awful lot."

Caitriona McPartlin, Chief Operating Officer of the ReproMed clinics in Dublin and Galway, said they were attempting to establish protocols to continue to treat patients.

"Once we know that we can open safely following the guidance of the Department of Health, we will do so," she said.

Dr Kennedy said that "in the fullness of time" clinics may have to "live with" additional risks.

"A lot of women that we have are on the clock and as months go by and people get older statistical chances of success drop and that's a terrible thing," he said.

Denise Phillips from Newbridge, Co Kildare, was just about to start a cycle of IVF when she was told the treatment could not proceed.

"It was a big shock because you mentally build yourself up so much that when somebody tells you that you can't go ahead it is just devastating. Beyond devastating."

Denise and her husband, Mark, have a five year-old daughter from a previous IVF treatment and had hoped to expand their family this year.

"I had an initial consultation and was going in to start my scans, get my medication and start our journey but then I got a phone call saying that all IVF cycles were postponed or cancelled.

"Obviously, the Government has to do things that are right, but it's awful for somebody to take away your chance after all that's already been taken from you. What happens if this is around for a long time?"

Denise said that fertility patients are suffering "huge anxiety".

"Their families don't know they are having treatment and they are in isolation. They don't want to leave the house in case they pick up something and then won't be able to get treatment once the clinics reopen. Everyone's mind is racing."

Once fertility services resume, there are concerns over a potential backlog of patients. However, Dr Kennedy said plans are being made to increase opening hours and treatment capacity.

He said: "We are retaining staff and holding on to people so when it comes time to hit the ground running we are in a position to do so.

"It is in everyone's interest to reopen. It will be all hands to the pump."

The rest is here:
Hundreds of patients affected by closure of IVF clinics - RTE.ie

Embryology

Neurologic Symptoms and COVID-19: What’s Known, What Isn’t – Medscape

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Since the Centers for Disease Control and Prevention (CDC) confirmed the first US case of novel coronavirus infection on January 20, much of the clinical focus has naturally centered on the virus' prodromal symptoms and severe respiratory effects.

However, US neurologists are now reporting that COVID-19 symptoms may also could include encephalopathy, ataxia, and other neurologic signs.

"I am hearing about strokes, ataxia, myelitis, etc," Stephan Mayer, MD, a neurointensivist in Troy, Michigan, posted on Twitter on March 26.

Other possible signs and symptoms include subtle neurologic deficits, severe fatigue, trigeminal neuralgia, complete/severe anosmia, and myalgia as reported by clinicians who responded to the tweet.

Last week, as reported by by Medscape Medical News, the first presumptive case of encephalitis linked to COVID-19 was documented in a 58-year-old woman treated at Henry Ford Health System in Detroit.

Physicians who reported the acute necrotizing hemorrhagic encephalopathy case in the journal Radiology counseled neurologists to suspect the virus in patients presenting with altered levels of consciousness.

Researchers in China also reported the first presumptive case of Guillain-Barre syndrome associated with COVID-19. A 61-year-old woman initially presented with signs of the autoimmune neuropathy GBS, including leg weakness, and severe fatigue after returning from Wuhan, China. She did not initially present with the common COVID-19 symptoms of fever, cough, or chest pain.

Her muscle weakness and distal areflexia progressed over time. On day 8, the patient developed more characteristic COVID-19 signs, including 'ground glass' lung opacities, dry cough, and fever. She was treated with antivirals, immunoglobulins, and supportive care, recovering slowly until discharge on day 30.

"Our single-case reportonly suggests a possible associationbetween GBS andSARS-CoV-2 infection. It may or may not havecausal relationship. More caseswith epidemiological data are necessary," senior author Sheng Chen, MD, PhD, told Medscape Medical News.

However, "we still suggest physicians who encounter acute GBS patients from pandemic areas protect themselves carefully and test for the virus on admission. If the results are positive, the patient needs to be isolated," added Chen, a neurologist at Shanghai Ruijin Hospital and Shanghai Jiao Tong University School of Medicine in China.

Neurologic presentations ofCOVID-19 "are not common, but could happen," Chen added. Headache, muscle weakness and myalgias have been documented in other patients in China, he said.

We know almost nothing about the potential interactions between COVID-19 and the nervous system. Dr Robert Stevens, Johns Hopkins School of Medicine, Baltimore

Despite this growing number of anecdotal reports and observational data documenting neurologic effects, the majority of patients with COVID-19 do not present with such symptoms.

"Most COVID-19 patients we have seen have a normal neurological presentation. Abnormal neurological findings we have seen include loss of smell and taste sensation, and states of altered mental status including confusion, lethargy, and coma," Robert Stevens, MD, who focuses on neuroscience critical care at the Johns Hopkins School of Medicine in Baltimore, Maryland, told Medscape Medical News.

Other groups are reporting seizures, spinal cord disease, and brain stem disease. It has been suggested that brain stem dysfunction may account for the loss of hypoxic respiratory drive seen in a subset of patients with severe COVID-19 disease, he added.

However, Stevens, who plans to track neurologic outcomes in COVID-19 patients, also cautioned that it's still early and these case reports are preliminary.

"An important caveat is that our knowledge of the different neurological presentations reported in association with COVID-19 is purely descriptive. We know almost nothing about the potential interactions between COVID-19 and the nervous system," he noted.

He added it's likely that some of the neurologic phenomena in COVID-19 are not causally related to the virus.

"This is why we have decided to establish a multisite neuro-COVID-19 data registry, so that we can gain epidemiological and mechanistic insight on these phenomena," he said.

Nevertheless, in an online report February 27 in the Journal of Medical Virology, Yan-Chao Li, MD, and colleagues write that "increasing evidence shows that coronaviruses are not always confined to the respiratory tract and that they may also invade the central nervous system, inducing neurological diseases."

Li is affiliated with the Department of Histology and Embryology, College of Basic Medical Sciences, Norman Bethune College of Medicine, Jilin University, Changchun, China.

Scientists observed SARS-CoV in the brains of infected people and animals, particularly the brainstem, they note. Given the similarity of SARS-CoV to SARS-CoV2, also known as COVID-19, the researchers suggest a similar invasive mechanism could be occurring in some patients.

Although it hasn't been proven, Li and colleagues suggest COVID-19 could act beyond receptors in the lungs, traveling via "a synapseconnected route to the medullary cardiorespiratory center" in the brain. This action, in turn, could add to the acute respiratory failure observed in many people with COVID-19.

Other neurologists tracking and monitoring case reports of neurologic symptoms potentially related to COVID-19 include Mayer and Amelia Boehme, PhD, MSPH, an epidemiologist at Columbia University specializing in stroke and cardiovascular disease.

Boehme suggested on Twitter that the neurology community conduct a multicenter study to examine the relationship between the virus and neurologic symptoms/sequelae.

Medscape Medical News interviewed Michel Dib, MD, a neurologist at the Piti Salptrire hospital in Paris, who said primary neurologic presentations of COVID-19 occur rarely and primarily in older adults. As other clinicians note, these include confusion and disorientation. He also reports cases of encephalitis and one patient who initially presented with epilepsy.

Initial reports also came from neurologists in countries where COVID-19 struck first. For example, stroke, delirium, epileptic seizures and more are being treated by neurologists at the University of Brescia in Italy in a dedicated unit designed to treat both COVID-19 and neurologic syndromes, Alessandro Pezzini, MD, reported in Neurology Today, a publication of the American Academy of Neurology.

Pezzini notes that the mechanisms behind the observed increase in vascular complications warrant further investigation. He and colleagues are planning a multicenter study in Italy to dive deeper into the central nervous system effects of COVID-19 infection.

Clinicians in China also report neurologic symptoms in some patients. A study of 221 consecutive COVID-19 patients in Wuhan revealed 11 patients developed acute ischemic stroke, one experienced cerebral venous sinus thrombosis, and another experienced cerebral hemorrhage.

Older age and more severe disease were associated with a greater likelihood for cerebrovascular disease, the authors report.

Chen and Li have disclosed no relevant financial relationships.

Follow Damian McNamara on Twitter: @MedReporter. For more Medscape Neurology news, join us on Facebook and Twitter.

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Neurologic Symptoms and COVID-19: What's Known, What Isn't - Medscape

Immunology

William Frankland, global authority on the treatment of allergies obituary – Telegraph.co.uk

William Frankland, who has died aged 108, worked with Alexander Fleming, the discoverer of penicillin, persuaded Saddam Hussein to give up his 40-a-day habit and, as one of the most eminent and senior practitioners in the management and treatment of allergy, championed the view that an allergic reaction is due to a malfunctioning immune system; he also developed the idea of a pollen count to help hay fever sufferers.

In 2012, at the age of 100, Frankland who was known to all as Bill became probably the worlds oldest expert witness when he was called by the defence to prepare a report on a motorist charged with dangerous driving, who claimed that a delayed reaction to a wasp sting had caused him to pass out, with the result that he had become involved in a head-on collision.

The prosecution alleged that the defendant had been distracted while changing tracks on his iPod or using his mobile phone. In his evidence Frankland confirmed that the defendant suffered from an allergy to wasp stings.

But he agreed with a prosecution witness that cases of delayed reaction occur only where a patient has shown symptoms immediately after a sting which the defendant had not. The man was duly convicted.

Franklands career in immunology began in the 1950s when he joined the Department of Allergic Disorders in the Wright-Fleming Institute at St Marys, Paddington, dealing with patients who suffered from seasonal hay fever.

He and his colleagues undertook a series of trials which showed that antihistamine tablets, the standard treatment at the time, were ineffective against pollen asthma. After publishing the results in a paper in the Lancet entitled Prophylaxis of Summer Hay-fever and Asthma, to facilitate further research Frankland took over the running of St Marys pollinarium, turning it into the worlds largest pollen production plant.

Frankland argued that the rise in levels of allergy can be linked to increased levels of hygiene in modern life, noting, for example, that people living in the former East Germany experienced much lower levels of allergies than their counterparts in the more prosperous West Germany.

He became a leading proponent of allergen immunotherapy, in which the patient is vaccinated with increasingly larger doses of an allergen with the aim of inducing immunological tolerance, and was the first clinician to demonstrate the benefits of grass pollen immunotherapy.

Over the years, tens of thousands of his patients injected themselves with pollen on a daily basis.

Frankland was keen to provide hay fever sufferers with information about the level of pollen in the air, and on his recommendation St Marys recruited a full-time botanist to produce pollen counts. Weekly London counts were sent to members of the British Allergy Society from 1953 and to the media every day from 1963.

Frankland went on to study insect venom allergies, using himself as a subject. Through the London School of Tropical Medicine, he obtained the South American species Rhodnius prolixus, which he could be sure he had never been bitten by before, to measure his own allergic reaction.

After the insect had bitten him at weekly intervals for eight weeks, he suffered a severe anaphylactic shock and nearly died: All I could do was hold up three fingers to indicate the doses of adrenalin the nurse should inject me with, he recalled.

The son of a parson, Alfred William Frankland was born in Sussex on March 19 1912. His mother had had no idea she was expecting twins until his arrival closely followed that of his brother Jack. My cot was a chest of drawers, he recalled.

He grew up in the Lake District and attended St Bees School, before studying medicine at Oxford and St Marys, where as a student he ran for London University against Oxford and Cambridge and captained the hockey team. He began his first job at St Marys as a house physician to Winston Churchills doctor Charles Wilson (later Lord Moran) in 1938.

At the outbreak of war, Frankland joined the Royal Army Medical Corps and was promoted captain. Posted to Singapore, on arrival he tossed a coin with a colleague to decide upon the institution where each would work.

Some two months later, on February 15 1942, the Japanese swept into Singapore. His colleague, who had gone to the Alexandra Hospital, died there along with other staff, killed by Japanese soldiers armed with bayonets. Frankland survived the invasion but endured three and a half years of hell in an internment camp on Blakang Mati Island.

Despite the gruelling tropical heat, the shortage of food and diseases such as beriberi, dengue fever and dysentery, Frankland retained enough intellectual curiosity to notice and wonder why the Japanese guards seemed remarkably unaffected by bites from native insects to which many of his fellow PoWs were allergic.

After liberation, so emaciated that even sitting down was painful just bones on a hard seat Frankland was flown in a convoy of three Dakotas to Rangoon for rehabilitation and a ship home. The aircraft hit a storm over the mountains of southern Burma, and one did not make it.

After V-J Day he returned to St Marys to specialise in dermatology, but decided to apply for a part-time job at the hospital working in allergies which ended up being his vocation.

During the early 1950s he served as clinical assistant to Alexander Fleming and later wrote a chapter on penicillin for a book edited by Fleming, in which he predicted (correctly) that Flemings wonder drug would cause allergic reactions in some patients.

Fleming, who did not really believe in allergies, made him change the passage: He was wrong, Frankland observed, but you cant really argue with a Nobel Prize winner.

Frankland became director of the Allergy Department (now the Frankland Clinic) at St Marys in 1962 and subsequently undertook research into latex allergy among other conditions. After retiring in 1977 he worked as an allergist at Guys Hospital for 20 years, but in 1997, aged 85, returned to St Marys as an emeritus consultant.

Frankland treated royalty, stars and even dictators. In 1979 he was flown to Iraq to treat Saddam Hussein, who was being treated with desensitising injections for some unspecified allergy.

He wasnt allergic at all, Frankland recalled. His problem was that he was smoking 40 cigarettes a day. I told him to stop and if he wouldnt I would refuse to come and see him again. I dont think anyone had spoken to him like that before.

I heard some time later that he had had a disagreement with his secretary of state for health, so he took him outside and shot him. Maybe I was lucky.

Frankland made a significant contribution to organisations concerned with allergies. He was honorary secretary of the Asthma Research Council for 35 years and served as president of the Anaphylaxis Campaign and of the British Allergy Society (now the British Allergy and Clinical Immunology Society), which established the William Frankland Award for Outstanding Services in the field of Clinical Allergy in 1999.

He was president of the European Academy of Allergy and Clinical Immunology and the International Association of Aerobiology, and was a founder member of Asthma UK. In 2006 Frankland was awarded the Clemens von Pirquet Medal for Clinical Research.

On his 100th birthday in 2012, Frankland was as busy as ever. He had just had a paper accepted by The Journal of Allergy and Clinical Immunology and said he had no intention of stopping work. He told The Daily Telegraph: If I wasnt interested in things how would I do in my old age? I hope I am just going to keep going. In 2015 he was made an MBE.

William Frankland married Pauline; she died in 2002, and he is survived by their three daughters and a son.

William Frankland, born March 19 1912, died April 2 2020

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Immunology

Exercise and the immune Response – Edgefieldadvertiser

By Paul Gustafson, PhD, RKT, RPG Kinesiotherapy, LLC, Edgefield, SC

In recent weeks there has been an increased interest in methods to protect oneself from infection. Reducing ones exposure to infection has recently been a priority in our minds and in media reports. Another topic receiving somewhat less but important attention is that of maintaining and enhancing ones immune response to infection. Our immune system uses cells of various types as warriors to resist or combat infections and chronic disease. There is evidence that a regular exercise program can enhance the performance of our immune system (5).

It has been known for some time that cardiorespiratory exercise, also known as aerobic exercise, can enhance the performance of our immune system (5) by increasing the numbers of some of the cellular warriors to one degree or another. Activities using large muscle groups, performing large limb movements, performed rhythmically for an extended period of time can qualify as cardiorespiratory exercise.

More recently, resistance training (strength training) has also been shown to enhance the performance of the immune system in women with breast cancer (3). Ultra-high intensity resistance training is not necessary to increase the numbers of some of the cellular warriors of the immune system. In fact there is some debate regarding evidence that exercise of ultra-high intensity may temporarily suppress the immune system in highly trained, elite athletes (4). Regardless of the outcome of that debate, there is significant agreement in the scientific community that regular bouts of moderate to vigorous intensity exercise will assist the immune system to function properly and will help to lower the risk of respiratory illness/infection and some cancers (4). Exercise routines found successful in sedentary or moderately active individuals may not translate to highly trained, elite athletes (6).

Before beginning an exercise program ones physician should be consulted. The American College of Sports Medicine (ACSM) recommends 150-300 minutes per week of moderate-intensity aerobic physical activity and 2 sessions per week of strength training. There are indoor and outdoor activities that may be used to meet the ACSM guidelines (1). In order to maintain immune health one should begin with an easily tolerated intensity and gradually increase the intensity over a period of weeks. Adding variety of activity will assist in decreasing the monotony of the exercise routine (6). The ACSM offers a list of specific activities one can use to meet their guidelines. There are also frequently asked questions with reference to COVID-19 addressed on their website as well (1).

Exercise is not the only variable that can affect the immune system. Factors such as potential exposure to disease causing organisms, health status, lifestyle behaviors, sleep and recovery, nutrition and psychosocial issues also play a role (4, 6). In 2007 The ACSM along with the American Medical Association (AMA) co-launched the Exercise is Medicine (EIM) initiative. The purpose of EIM is to make physical activity assessment and promotion a standard in clinical care (2).

Exercise engagement is something we can immediately control. You are encouraged to follow the lead of the ACSM and AMA and ask your healthcare provider for recommendations regarding exercise in your health maintenance plan.

1. http://acsm.org/read-research/newsroom/news-releases/news-detail/2020/03/16/staying-physically-active-during-covid-19-pandemic

2. https://www.exerciseismedicine.org/support_page.php/about-eim/

3. Hagstrom, AD et al. (2016). The effect of resistance training on markers of immune function and inflammation in previously sedentary women recovering from breast cancer: a randomized controlled trial. Breast Cancer Research and Treatment, 155: 471-82.

4. Simpson, RJ et al. (2020). Can exercise affect immune function to increase susceptibility to infection? Exercise Immunology Review, 26:8-22.

5. Walsh, NP et al. (2011). Position Statement Part one: Immune function and exercise. Exercise Immunology Review, 17: 6-63. 6. Walsh, NP et al. (2011). Position Statement Part two: Maintaining Immune Health. Exercise Immunology Review, 17: 64-103.

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Exercise and the immune Response - Edgefieldadvertiser

Immunology

What it means to be immunocompromised and the conditions that put you at risk of infection – Business Insider

captionSomeone who is immunocompromised has a higher risk of infection.sourceurbazon/Getty Images

Human bodies are naturally equipped to fight off infections with the help of a complex immune system and infection-fighting white blood cells. However, certain groups have a much harder time warding off infections and staying healthy due to a weakened immune system. This is called being immunocompromised.

Those who are immunocompromised, or sometimes referred to as immunosuppressed, are more vulnerable than the general public to infections caused by viruses, bacteria, fungi, and parasites. On top of this, they are more likely to suffer from serious complications from infections that they pick up.

During epidemics such as what we are experiencing with the COVID-19 outbreak, they are at higher risk for serious illness if they become infected by the virus, says Nicolas Vabret, PhD, assistant professor of Immunology at Mount Sinai in New York City.

If someone is immunocompromised due to a virus, such as HIV, its even harder to fight a secondary infection since the body is already fighting a virus. Thats because the body only has so many infection-fighting white blood cells.

For example, one common problem people with HIV or AIDS may face is pneumonia. According to a 2017 study published in the scientific journal Pneumonia, pneumonia the illlness is one of the most common infections causing morbidity and mortality in those with HIV/AIDS.

Many conditions can cause somebody to become immunocompromised. Some of the most common are:

Aside from diseases, various treatments can cause someone to become immunocompromised. Certain kinds of treatment and therapies, such as anticancer treatments, or treatments received during an organ transplant are also immunosuppressive and can render patients vulnerable to virus infection, says Vabret.

Elderly people are also considered to be immunocompromised, since aging naturally causes the immune system to weaken.

People who are immunocompromised must take extra precautions to protect themselves from illnesses, and the first step to this is living a healthy lifestyle.

Exercise regularly: Staying active and exercising regularly can boost your immune system and may help the body fight infections.

Get enough sleep: According to a 2015 study published in the Journal of Immunology Research, sleep deprivation makes you more susceptible to viral and bacterial infections, so its especially smart for immunocompromised people to get quality sleep. Avoid vices: Vabret also urges immunocompromised people to avoid vices that can weaken the immune system even further, such as smoking, drinking alcohol, and eating excessive junk food.

Eat a healthy diet: Eating a diet rich in vitamins and minerals is critical for maintaining good health. Vitamin C, Vitamin B6, and Vitamin E are great immunity boosters, according to Cleveland Clinic. Its best to get these vitamins (and any other vitamins) through food rather than supplements since your body often absorbs them more easily this way.

Stay clean: Cleanliness is crucial for immunocompromised people. Vabret says they should wash their hands often and thoroughly, avoid touching their face, and clean surfaces in their homes that they touch frequently, especially if these surfaces are shared with other people.

During an outbreak, be extra careful: During an outbreak, like with COVID-19, the immunocompromised have to take strict measures to ensure their safety. They should practice self-isolation and reduce interaction with other people during the course of the epidemics. This may not be easy, but it is the safest strategy, says Vabret. They should plan solutions to avoid having to go into crowded public places such as supermarkets, restaurants, and social events. The overall objective is to adapt your lifestyle to reduce your exposure to the virus.

More tips: Check out our article on how to boost the immune system for more detailed tips.

If youre immunocompromised, remember, its always better to be safe than sorry. Be responsible and make decisions that put yourself and your health first.

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What it means to be immunocompromised and the conditions that put you at risk of infection - Business Insider

Immunology

Are Clinicians Aware of the FDA’s Pregnancy and Lactation Labeling Rule? – Medical Bag

Many women use at least 1 medication during pregnancy. In 2015, the Pregnancy and Lactation Labeling Rule (PLLR) was introduced in order to integrate summaries of the risks of using a particular drug or biologic agent during pregnancy and lactation. However, this system is still not used by clinicians. A study sought to determine clinicians awareness and use of PLLR and the results were published in The Journal of Allergy and Clinical Immunology.

An online survey was developed by the US Food and Drug Administration in collaboration with the American Academy of Allergy, Asthma & Immunology (AAAAI) and conducted in 2018 with the hope of better understanding clinician use of the PLLR. A total of 184 members of the AAAAI who were part of a randomly selected group chose to participate in the survey. Respondents were 66% male, average age 56 years, part of a single or multi-specialty group practice, and treating an average of 2 pregnant women a month. Clinicians were asked whether they were aware of the introduction of the PLLR. Results showed that only 46% of respondents were aware that the narrative summary of risks had replaced the prior letter system, and almost all clinicians said they continued to use the previous system. Most (71%) cited that they had never referred a pregnant patient to a pregnancy exposure registry, but more than half said they would refer patients in the future. A total of 56% of respondents cited that the narrative summary system was too detailed and unclear compared with the letter-based system.

Despite this, many clinicians did find the new narrative summary labeling helpful. Investigators wrote that the most pressing issue identified by the survey was the fact that the majority of clinician respondents were not aware of the PLLR.

There are some study limitations that may help explain this disparity. Many of the respondents were older and treated mostly non-pregnant patients, as well as working in allergy and immunology specialties. A more diverse sample of respondents may yield different results. In addition, a future survey could be useful in understanding why clinicians continue to use the letter system despite the existence of the PLLR.

According to the investigators, the survey reveals a need to educate clinicians in this specialty area on medication risks in pregnancy going forward. This could be met via increased awareness of the new labeling system or development of a multi-product specialty-specific registry.

Reference

Namazy J, Chambers C, Sahin L, et al. Clinicians Perspective of The New Pregnancy and Lactation Labeling Final Rule (PLLR): Results from an AAAAI/FDA Survey [published online February 18, 2020]. J Allergy Clin Immunol Prac [published online February 19, 2020]. doi:https://doi.org/10.1016/j.jaip.2020.01.056

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Are Clinicians Aware of the FDA's Pregnancy and Lactation Labeling Rule? - Medical Bag

Immunology

Amgen And Adaptive Biotechnologies Announce Strategic Partnership To Develop A Therapeutic To Prevent Or Treat COVID-19 | Antibodies | News Channels -…

DetailsCategory: AntibodiesPublished on Friday, 03 April 2020 10:50Hits: 300

Amgen Will Leverage Genetics, Immunology, Antibody Engineering and Manufacturing Capabilities

Companies Will Begin Work Immediately

THOUSAND OAKS, CA, and SEATTLE, WA, USA I April 2, 2020 I Amgen (NASDAQ:AMGN) and Adaptive Biotechnologies (NASDAQ:ADPT) today announced a collaboration aimed at helping address the COVID-19 pandemic. The companies will combine expertise to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19.The mutually exclusive collaboration brings together Adaptive's proprietary immune medicine platform for the identification of virus-neutralizing antibodies with Amgen's expertise in immunology and novel antibody therapy development. Given the rapidly rising incidence of COVID-19 around the world, the companies will begin work immediately and finalize financial details and terms in the coming weeks.

Neutralizing antibodies defend healthy cells by interfering with the biological function of an invading virus. These antibodies may be used therapeutically to treat someone currently fighting the disease and can be given to people who have heightened risk of exposure to SARS-CoV-2, such as healthcare workers.

"Our strong history of collaboration with Adaptive gives us the ability to immediately mobilize our combined resources to help address the urgency in controlling the COVID-19 pandemic. After swiftly obtaining viral gene sequences from hundreds of patients, Amgen was motivated to use theseinsights and quickly pair them with our drug development and manufacturing capabilities. Working with Adaptive and using their viral-neutralizing antibody platform will expedite our ability to bring a promising new medicine into clinical trials as quickly as possible," said Robert A. Bradway, chairman and chief executive officer at Amgen.

Adaptive will extend its high throughput platform to rapidly screen the massive genetic diversity of the B cell receptors from individuals that have recovered from COVID-19. This enables the identification of tens of thousands of naturally occurring antibodies from survivors of COVID-19 to select those that neutralize SARS-CoV-2. Amgen will then leverage its world-class antibody engineering and drug development capabilities to select, develop and manufacture antibodies designed to bind and neutralize SARS-CoV-2. deCODE Genetics, a subsidiary of Amgen located in Iceland, will provide genetic insights from patients who were previously infected with COVID-19.

"We are extremely motivated to join forces with our trusted partner, Amgen, to tackle this global health crisis," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "This partnership expands our drug discovery capabilities, demonstrating the power and versatility of our immune medicine platform."

The two companies have signed a Memorandum of Understanding to enable the parties to start work immediately and are planning to execute a Collaboration and License Agreement. Terms of the agreement are not being disclosed. Both companies aim to accelerate the development of a potential antibody against COVID-19 as fast as possible for patients in need.

About AmgenAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit http://www.amgen.comand follow us on http://www.twitter.com/amgen.

About Adaptive BiotechnologiesAdaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature's most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in life sciences research, clinical diagnostics, and drug discovery. We have two commercial products, and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. For more information, please visitadaptivebiotech.comand follow us on http://www.twitter.com/adaptivebiotech.

SOURCE: Amgen

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Immunology

Covid-19 and psycho-immunology of panic – Thrive Global

Weare living in a memorable time indeed.

Thisarticle is an exploration of one question: given the current situation, didyou reach out for more toilet paper or more connection?

Im sure youve had a thought or two about the toilet papersituation at this point. Its a global event. Ive come to see it assymptomatic of what Freud called a cornerstone that civilization requires toexist, i.e., the renunciation of instinct.

Toput it simply: Id. Primitive, instinctive, unsophisticated Id.

Freudsoriginal insight suggests that the sublimation of primitive aggressivetendencies is a pre-requisite for civilization. It is impossible to overlookthe extent to which civilization is built up upon a renunciation of instincthe noted. The repression of aggressive instincts is perhaps one of the mostimportant functions our ego has. An injured, or maladaptive ego (aswe say in clinical jargon), doesnt sublimate aggression well. Redirectedaggression or sublimated anything ideally turns into creativity and curiosity,by the wayboth a healthy thing.

Ascared human is not a creative, curious human.It doesnt get simpler. Most of us are familiar with the notion of the reptilianbrain, and currently, you can feel it right here in your gut PANIC. Themessage comes automatically from the survival part of the brain through ourbodily sensations, feelings, emotions and thoughts.

Itscreams: Hoard, protect, hide, cover. Mine!

Whatis furthermore unique during this time is that the message of uncertainty isofficial. The Covid-19s response team from the Imperial College in London,which is about as formal and authoritative as one can get, notes:

We, therefore, conclude that epidemic suppression is the onlyviable strategy at the current time. Thesocial and economic effects of themeasures which are needed to achieve this policy goal will beprofound However, we emphasize that it is not at all certain (emphasismine) that suppression will succeed long term; no public health interventionwith suchdisruptive effects on society has been previously attempted forsuch a long duration of time. Howpopulations and societies will respond remainsunclear(emphasis mine).

Thedefining characteristic of a traumatic event is perceivedhelplessness. Covid-19s imposition on the changes related to our day-to-day(look at Zoom stock) are less significant than the uncertaintyrelated to its outcome in the long term.

Thisuncertainty is evident in the questions that are elicited How long will itlast? When will things go back to normal? Can I (fill in the blank) whilethe epidemic is going on? Short of what authorities are describing aspreemptive personal hygiene measures in the social sphere, the truth is that theuncertain is greater than that which is certain now.

Thehuman brain particularly the amygdala does not like unknowns. But thatsbeside the point here. Let us get back to the toilet paper.

Toiletpaper. Toilet paper is panic, its primitive, its Id. What did we do for allthose years before we had any? I wonder! Its a well-known principle thatcharacter reveals itself under pressure. This principle has certainly applieditself in my own life; however, it is also true that many people may not haveexperienced the level of demand, uncertainty, and dread that Covid-19 elicits.The virus, therefore, has become an induced initiatory experience for most ofthe population.

Initiationinto what you ask. Stillness.

Onemust admit, however, that initiation into stillness implies a privileged pointof view. Our current social reality is that most of us are about to havematters made worse by this situation. Unfortunately, wrapping ourselves intoilet paper wont help.

Medical providers and emergency responders (all of whom willmost likely become ill) are running out of supplies and require donations towork.

Additionally,many are at risk of entering into a state of economic duress, which would becompounded by becoming ill: Oh, the medical bills if you end up needing thatrespirator!

Forthose who find themselves in the throes of economic duress compounded byillness or the fear of becoming ill, one word applies: Endure.

Itwill not help to fight the injustices of the system, or to try to make sense ofwhy airlines get bailouts while we cant pay our rent. We must pause, take aknee, and learn to calm our nervous systems down. When this is over, the resiliencewe have developed will allow us to flourish, and to take a stand for authenticindependence in our lives.

Thewisdom of political resistance applies here: Dont let the system get youdown. Trust me; Im an immigrant, and I know a thing or twoabout systemic pressures in this country.

Covid-19has not diverted the world from its path of economic inequality. On thecontrary, it has inflamed it. The clinical consequences are only one side ofthe problem. Im not proposing complacency about present inequalities far fromit. Rather, this is a call to see the situation as it immediately demands. Letus fight in one impossible battle at a time.

Letus attend further to the enemy at hand: fear itself.

Intrinsicto this situation and regardless of our economic status is the fear it produces.The brain here enters into a state of acute hyper-arousal triggering our mostbasic survival complex. This state supersedes our capacity for rationalexecutive functioning, e.g., understanding the contemplation being offered here.

Naturesdesign is quite sophisticated, after all, and when shit hits the fan weeither fight, run, or play dead. Crises unmask us, expose us and make us vulnerable.Such crises trigger every psychological defense available to us. And when thosefail? Dread sets in. You know the dark stuff.

Thebottom line is this: panic-buying, or pandemic-consumerism, is asymptomatic reflection of a nervous system gone astray. It isirrational behavior a mind confused and intensely reactive to itsprojections, primitive regression, and catastrophic thinking.

This survival strategy has obvious limits and misses the fact that the same environment that gave us the primitive drive, also gave us the pre-frontal lobe. However, we must decide to access it. Victor Frankl (someone the whole world should get acquainted with right about now if they havent yet) famously noted that:

Everything can be taken () but one thing: the last of thehuman freedomsto choose ones attitude in any given set of circumstances, tochoose ones own way.

Frankls was a human insight birthed within a concentration camp. Something similar was suggested in WWII as a morale campaign during the bombing in London hence the sign. Who would have thought that the British stiff-upper-lip could be used as a paragon of sanity for the time?

Butaccessing the pre-frontal cortex is not just a choice (it is that too). It is asystemic, whole-body, physiological event. It is a central nervous system state.And accessing this state, for almost all of us, requires training the mind-body.

Yousee, stillness and distraction dont go together. And for the most part, we areall very distracted. We have become accustomed to a way of life in which thevirtual domain outweighs our direct sensory experience of the ourselves and theworld. Social media and the world of virtual social interactions have made itso that the desired image of ourselves outweighs reality. Covid-19 is a realitytesting principle the world was not expecting.

Becausewe are habituated to the blinding pace of our current world slowing down willfeel initially like a shock. Ive seen this repeatedly in meditation retreats orin wilderness solos, where students sit by themselves in Nature for severaldays at time. These practices arethousands of years old, and have been understood for millennia to havetremendous psychological and spiritual significance.

Ihave certainly experienced this myself.For me, it usually takes about three days of sitting for the staticwhite noise of the city to go away. There is a ringing in the ears that all ofa sudden lets up, allowing me to yield and relax; It is something hard toexplain; however, it happens to most of us, and nowadays, its measurable in alab.

However,lab measurements of brain wave activities during meditation practice are notthe point. Reactionary and aggressive protest around stillness is the point. Italmost sounds too benign to be true: defense-against-silence asthe core issue. But I propose that it is.

BlaisePascal noted famously that Allof humanitys problems stem from one persons inability to sit quietly in aroom alone.

Idont know about all, but I certainly know about most. In addition,the incapacity for stillness adds to all the other problems most of thetime, because an anxious mind projects fear everywhere and regresses intoneurotic self-preservation, as we discussed before.

Allof this ends up compromising the immune system. How do I know this? Becausestress kills. And if it doesnt kill you, it will certainly injure you. Morespecifically, your response to your fear will effect your immune system.

Fearis but a primitive, startle-based survival impulse that, at its best, serves asan orienting function. You want to be able to alert to the danger and be ableto respond to it as the situation demands. But anticipating the punch, blockingit before it comes, countering before the opening is there all miss thewisdom of timing things. Anticipatory anxiety is a fear-based reaction that iscurrently making the crises worse. The epidemiology of Covid-19 is irrelevantinsofar as the incapacity to sit still with uncertainty goes. More importantly,it misses the insight that this is controllable, for each individualthrough the practice of stillness.

EmilyLandon, the chief infectious disease epidemiologist at the University ofChicago Medical School, touched upon this when she noted that the healthy andoptimistic among us will doom the vulnerable. She went on to say, that wewould be right to feel that the strategy of saving the world by doing nothingwas anti-climactic.

However, doing nothing ishardly as easy as it sounds.

It remains true that beforethis virus, we measured the value of life solely by doing more and more. Bemore efficient, more productive, more successful. At what cost? At the cost ofall our relationships, the eco-system included. Greed and ambition have nolimits, are always rewarded, and bailed out when they fail.

It will take courage not tobe defined by the pathological lack of empathy that drives so much of thissystem as it stands.

We text rather than call,post rather than engage, and push the like button because its just so damneasy. All of which contradicts the existential reality that the deepest communicationis mostly non-verbal! Were not built to look all day at the little screen;were made to look at each other. Babies and mothers know this for certain; nevertheless,it is true for all of us. We were all infants once, and we will never outgrowthat mirroring. Thank goodness!

As a mental health professional,I am stunned at the lack of public initiatives that address the primacy ofmental health in a moment like this. We all need the medical system to work. JayashriKulkarni, a psychiatry professor at Monash University in Melbourne, notedrecently: There is a prevailing belief that in any crisis you deal with thephysical issues first, then the mental health issues much later. I challengethis view because we need the public to be robust mentally to deal withthe challenges ahead (my emphasis).

A psychology of endurancerequires us to trainourmindsto desire what thesituation demands, as Seneca noted about 2000 years ago. The current crisesrequires balance and patience from us. It requires not to get ahead ofourselves, and not to amplify fear and dread.

Sittingstill with uncertainty is as simple as it sounds but not as easy you think. Allyou have to do is sit down, turn everything off that habitually distracts you,and breathe. Close your eyes if you want it doesnt matter. Just. Sit. Still.I challenge you to do it! Greater good will come from building this resiliencethan anything else you can do right now. As a good friend of mine and inspiring artist wrote recently:

We are not in a hurry

We need not run

We are the ants busy building ourmound

We are the trees dried and chappedstanding firm

We are here for what comes

We are the grass that laid our seedlong ago

We are ready for this moment

We are always ready

We know what to do

We have always known what to do

We need not run

-RobertBellows

References:

https://www.washingtonpost.com/health/2020/03/20/emily-landon-coronavirus/

https://www.cnbc.com/2020/03/20/coronavirus-tips-for-protecting-your-mental-health-during-quarantine.html

Seneca

Victor Frankl., Mans Search forMeaning

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Covid-19 and psycho-immunology of panic - Thrive Global

Immunology

Too Much Salt May Lower Your Ability to Fight BacteriaHere Are Four Ways to Help Boost the Immune System – Newsweek

A high-salt diet can weaken the immune system and leave the body vulnerable to certain types of infection, according to immunologists writing in the journal Science Translational Medicine.

They investigated the effect a diet high in salt had on the immune system, first in mice and then in humans. The mice on saltier diets suffered more severe bacterial infections, while the humans displayed pronounced immune deficiencies.

"Our findings suggest that the daily recommended intake of 5 to 6 grams of salt should not be exceeded by much," corresponding author Christian Kurts, from the Institute of Experimental Immunology at the University of Bonn, told Newsweek.

"Lowering salt actually does not invigorate the immune system according to our work," he said. "The recommended salt amount seems to be good for the immune system."

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Kurts and his team compared the immune response of two groups of miceone fed a high-salt diet and the other a normal-salt dietto a urinary tract infection (UTI) caused by uropathogenic E.coli (UPEC).

The researchers found UTIs were aggravated by the high-salt diet, with the mice on these diets showing four to six times more UPEC than the control group. Recovery times also took longer; results that the author's attribute to hormones released to help the body excrete excess salt (glucocorticoids), which have the added effect of suppressing the immune system.

High-salt diets can also cause accumulation of urea in the kidney, which may suppress the antibacterial capabilities of white blood cells, the researchers suggest.

When the mice were infected with listeria, those on the saltier diet experienced more severe reactions to the bacteria. The researchers counted between 100 and 1,000 times the number of pathogens in the spleens and livers of mice in the high-salt category.

To investigate further, the researchers placed 10 volunteers on a high-salt diet for a week. This involved taking three tablets a day that added up to an extra 6 grams of salt to their dietequivalent to what you might find in 1.5 to two large fast food meals.

By the end of the week, the volunteers were showing signs of immunodeficiency. While numbers of neutrophils, a type of white blood cell, remained stable, their ability to fend of bacteria was lower than at the start of the study.

Concluding, the team say that because Western diets are now high in salt, "these findings reveal that people might be making themselves more vulnerable to bacterial infections."

Kurts said the best way people can boost the immune systems generally is to ensure they have had all appropriate vaccinations. "Apart from that, measures that are healthy in general are good also for our immune system: vitamins, moderate exercise, avoid junk food."

Below are four ways people can boost their immune system through diet and lifestyle.

There is a growing body of scientific evidence that suggests a healthy lifestyle revolving around good diet, exercise, sleep and reducing stress can help the immune system to run more efficiently.

In contrast to a high-salt diet, eating a healthy balanced diet consisting of plant-based fiber can support the body's "good" bacteria, which in turn may help the immune system, explained Dr. Louisa James, Lecturer in Immunology at Queen Mary University of London, U.K.

"The trillions of bacteria in our gut work in exquisite symbiosis with our immune system," James told Newsweek. "They stimulate our immune cells to make antibodies, they secrete by-products which maintain specialised immune cells that regulate our immune system and they even produce antibacterial and antiviral chemicals that can fight pathogens on our behalf."

Contrary to popular belief, there is limited evidence to show taking vitamin C supplements helps to fend off the flu, unless you are deficient in the first place. However, an analysis of 29 studies did suggest taking vitamin C supplements could reduce the amount of time a person infected with the common cold displayed symptoms, particularly if they were active.

James instead emphasizes the importance of vitamin D, which we mostly recieve through sunlight, in regulating the immune system.

"Vitamin D is essential for bone health but is also important for regulating our immune system," said James, pointing to research published in 2017 that found vitamin D supplements were a safe way to help protect people deficient in the vitamin from respiratory infections.

Vitamin D may help the body's macrophagesa type of white blood cellfunction better, while there is some evidence that vitamin E helps the T cells, "the other side of the immune system," Professor Janet Lord, Director of the Institute of Inflammation and Ageing at the University of Birmingham, U.K., told Newsweek.

Daniel Davis, Professor of Immunology at Manchester University, U.K., is skeptical about the role of nutrition on the immune system, telling Newsweek: "Obviously nutrition is important, certainly at some level, but it also seems to be very personal.

"The way that we respond to this or that food seems to vary hugely from one person to the next, and understanding why that is and being able to come up with clear health advice about nutrition is only just beginning to be done."

Davis, whose book The Beautiful Cure explores the immune system and the body's ability to fend off disease, points to the sheer number of books on nutrition and different dietary approaches, "which tells you something about the fact that we don't really know what's going on."

Another factor that research suggests could influence the body's response to infection is sleep.

Immune cells have adhesion receptors on their surface, explained James. These receptors (called integrins) enable them to move around the body and interact with other cells. However, levels can fluctuate depending on the presence of certain stress-related hormonessuch as adrenaline and noradrenaline.

In a paper published in the Journal of Experimental Medicine in 2019, scientists in Germany revealed levels of these hormones change throughout the day, dipping when we sleep. According to the study's authors, sleep loss can reduce levels of receptors on immune cells, which in turn may impair their ability to operate as effectively as they would under normal circumstances.

In contrast, regularly having a good night's sleep can enhance the immune system by improving immune cells' ability to attach to the targets.

Twin studies and laboratory tests have also emphasized the role of sleep in the proper functioning of the immune cells; showing shorter sleep durations are associated with a depressed immune system, while getting rest offers the immune system a chance to regroup when infection risk is low.

However, Davis says it can be hard to disentangle the effects of a lack of sleep from other factors, such as different eating times and stress.

"One thing that does seem to really affect the immune system is chronic stress," said Davis, and it relates to the hormone cortisol.

Levels of cortisol naturally peak and trough throughout the day, for example, rising as the body gets ready to wake up. The hormone plays an important role in the body's flight or fight response and remains at elevated levels when we are confronted by a source of stress.

"When you're in a state of fight or flight, your body is dealing with this current emergency and a lot of other bodily processes are dampened down," said Davis. These bodily processes include the immune system.

"This is fine in the short-termstress is not something to be entirely avoided. But if you have chronic stress and cortisol levels stay very high, it becomes a problem and makes you more susceptible to the flu and other viruses."

The obvious answer to this is to create an environment and lifestyle that minimizes sources of chronic stress, but Davis warns there is very little solid evidence that practices known to reduce stress can directly boost the immune system. The research is not there yet, he said.

"One thing that's becoming clear is that physical activityexerciseis a really powerful influencer of the immune system," said Lord, who co-authored a study investigating the immune system of cyclists aged 55 to 79. The researchers found their immune system more closely resembled that of a twenty- or thirty-something than someone their own age.

Movement gets the blood pumping and gives immune cells the chance to circulate the body. "Good circulation is essential to allow our immune cells to migrate throughout our body and perform their essential roles in immune surveillance," said James.

A key part of the immune response is inflammation and people who exercise regularly appear to have a more efficient immune system that is better at turning on and turning off inflammation, Lord explained, but warned that extended periods of sitting could undo the benefits.

"Sitting is the new smoking," she said. "We're hunter gatherers in a modern society. We haven't evolved to be sitting around all day."

Her advice is to not sit down for longer than an hour, even if it means walking up and down the stairs or investing in a standing desk. When it comes to physical activity, it doesn't matter what it isjust as long as you do it.

"Don't punish yourself by doing some form of physical activity you don't like. You like gardening, get out and do some gardening. If you like a brisk walk, do that," said Lord. "Just do something."

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Too Much Salt May Lower Your Ability to Fight BacteriaHere Are Four Ways to Help Boost the Immune System - Newsweek

Anatomy

Anatomy of an Outbreak: How Coronavirus Swept Through JPMorgans Trading Floor – The Wall Street Journal

March 9 was supposed to be the start of a new routine for JPMorgan Chase & Co. employees. With coronavirus spreading, the bank had told the staff in its stock-trading operation to head to three separate sites around New York City.

Hours before the workday began, with global markets plunging, technology at the sites wasnt ready. JPMorgan top brass reversed the order and told many traders to report for duty, as usual, to the firms Manhattan headquarters, employees said.

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Anatomy of an Outbreak: How Coronavirus Swept Through JPMorgans Trading Floor - The Wall Street Journal