Archive for January, 2020

KAPOSVAR, Hungary, Jan 31 (Reuters) - The Pongracz family, a couple who both serve as Lutheran pastors in western Hungary, consider it Gods blessing that they had their first baby after undergoing in-vitro fertilization in 2015.

Since their son Lazar was born, they also had twins - a boy and a girl - from a second IVF pregnancy, so their red-brick home attached to their church in a leafy district of Kaposvar is now filled with babies laughter.

They assist young couples with fertility problems by encouraging them to seek doctors help if thats the only way.

It was such an intense period for us, from the hormone treatment to the implantation of the embryos ... until it turned out that it was successful, that this gave us such a deep relationship with God that we never thought could be possible, said the mother, Boglarka Gyori.

Prime Minister Viktor Orban has made families a priority and introduced tax breaks and cheap loans to persuade more Hungarians to marry and have children as Hungarys population is declining rapidly.

It is an uphill struggle, with a productivity rate of 1.49, when 2.1 is needed to reverse the trend.

In December the government bought out six privately-owned fertility clinics. Drugs used in fertility treatments will be free of charge and waiting lists abolished, making state-financed IVF accessible to many more couples.

Some observers question why state ownership was needed and why the government did not just boost funding instead.

They say the move fits with Orbans efforts to centralise control over certain sectors and it could also help him lock in more of the conservative vote.

A human being cannot be a consumer item, family affairs state secretary Katalin Novak said, adding that the aim was to make treatments transparent and accessible to all.

When it turned out that she had a blockage in her fallopian tubes, making natural pregnancy almost impossible, Boglarka and her husband Mate wasted little time.

She was 27 and Mate was 30, and they spent all their savings on IVF at a clinic to avoid having to wait eight months for state-financed care. The second time they went for state-financed IVF, but still had to pay for medicines.

There were the parents, or rather the would-be parents, who were waiting and hoping, said Mate. With respect to our faith, the IVF programme was not a question for us. We have to take the opportunity that God had given us. (Reporting by Krisztina Than; Editing by Mike Collett-White)

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For Hungarian couple, prayers and science followed by gift of family - Reuters

INDIANAPOLIS, Jan. 28, 2020 /PRNewswire/ -- Starting this month, Eli Lilly and Company (NYSE: LLY) will donate at least 200,000 KwikPensto three relief organizations Americares, Direct Relief and Dispensary of Hope to stock insulin at nearly 200 U.S. free clinics through 2022. These donations will directly support lower-income people living with diabetes who qualify for free clinic services.

Separately, Lilly is providing $2 million to fund grants that relief agencies will distribute to a wide range of eligible free clinics. The grants will fund programs intended to help people with diabetes understand and access resources that can help them obtain medicine and supplies, medical care, insurance coverage and more.

The insulin donations include KwikPens of Humalog (insulin lispro injection 100 units/mL), Humalog Mix75/25 (insulin lispro protamine and insulin lispro injectable suspension), and Basaglar(insulin glargine injection 100 units/mL).Shipments to relief agencies have already started, giving lower-income people another option for accessing insulin.

"Dispensary of Hope is excited to expand the ongoing effort with Lilly's insulin donation program," said Chris Palombo, Dispensary of Hope CEO. "Insulin saves lives, and the addition of donated Humalog and Basaglar KwikPens is important for the nation's uninsured, low-income community."

In 2018, Lilly announced plans to donate insulin vials to stock approximately 150 U.S. free clinics. Since then, Lilly has donated 120,000 vials that have been used by people who qualify for free clinic services. Lilly is now sending KwikPens to the relief agencies for distribution to nearly 200 free clinics.

"This donation of KwikPens will help many people across the U.S. get the treatment they need," said Mike Mason, president, Lilly Diabetes. "With the help of the relief agencies, Lilly insulin will now be available in many free clinics that are equipped to properly store it. These clinics help people find comprehensive care such as medicine, devices, and physician support, and are very important to people who live with diabetes and use these services. We will continue to evaluate the needs of these communities and enhance our insulin donations as necessary.

"Lilly is committed to offering the broadest suite of solutions for people who need help affording their insulin," Mason continued. "But real change to our reimbursement system is needed. Insurance coverage should ensure no one with diabetes is forced to ration or skip doses for financial reasons."

These donations are part of a broader suite of solutions that Lilly is providing to people who need help affording their insulin. These options include lower-priced versions of branded insulins, out-of-pocket price caps at pharmacies for people with commercial insurance plans and help for people with immediate needs. Anyone who uses a Lilly insulin can call the Lilly Diabetes Solution Center at (833) 808-1234 (9 a.m. to 8 p.m. EST Monday through Friday) to see whether there is an option that reduces their out-of-pocket costs, including information about how to receive free insulin through a free clinic if they meet income requirements.

More information about the grants that relief agencies will receive can be found on our blog.

Important Safety Information for Basaglar, Humalog (Humalog U-100 and Humalog U-200), Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50

ContraindicationsBasaglar, Humalog (Humalog U-100 and Humalog U-200), Insulin Lispro Injection, Humalog Mix50/50, and Humalog Mix75/25 are contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine, insulin lispro, or any of their excipients.

Warnings and Precautions Never share a prefilled pen, cartridge, reusable pen compatible with Lilly 3 mL cartridges, or syringe between patients, even if the needle is changed.Patients using vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who repeatedly inject into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to the unaffected areas and to closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

Hypoglycemia is the most common adverse reaction associated with insulins, including Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50.Severe hypoglycemia can cause seizures, may be life threatening, or cause death.

Accidental mix-ups between insulin glargine (100 units/mL), basal insulin products, Humalog Mix75/25, Humalog Mix50/50, and other insulins, particularly rapid-acting insulins, have been reported.To avoid medication errors between insulins, instruct patients to always check the insulin label before each injection to confirm that the correct insulin is injected, including the correct insulin brand and concentration.

Do not transfer concentrated insulins (Humalog U-200) from the KwikPen to any syringe as overdosage and severe hypoglycemia can occur.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products,including Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50. If hypersensitivity reactions occur, discontinue use; treat per standard of care and monitor until symptoms and signs resolve.

All insulin products, including Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin.Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, or Humalog Mix50/50, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, dosage reduction or discontinuation of TZD must be considered.

Malfunction of an insulin pump device, infusion set, or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis.Patients using Humalog U-100 or Insulin Lispro Injection in subcutaneous insulin infusion pumps must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Adverse ReactionsAdverse reactions commonly associated with insulin glargine products, Humalog, Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50 are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.

Other adverse reactions commonly associated with insulin glargine products, Humalog Mix75/25, and Humalog Mix50/50 are weight gain and edema.

Drug InteractionsCertain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, or Humalog Mix50/50.

Click to accessBasaglar Full Prescribing Information, Humalog Full Prescribing Information, Insulin Lispro Injection Full Prescribing Information, Humalog Mix75/25 Full Prescribing Information and Humalog Mix50/50 Full Prescribing Information.

See Instructions for Use provided with pen/vial/syringe.

BV HI BOI SP HCP ISI NOV2019

About DiabetesApproximately 30 million Americans1 and an estimated 463 million adults worldwide have diabetes.2 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone.1 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.

About Lilly DiabetesLilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes. We offer a wide range of therapies and a continued determination to provide real solutionsfrom medicines and technologies to support programs and more. For the latest updates, visit lillydiabetes.com or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

About Eli Lilly and CompanyLilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Humalog (insulin lispro injection 100 units/mL), Basaglar (insulin glargine injection 100 units/mL), and Humalog Mix75/25 (insulin lispro protamin and insulin lispro injectable suspension) as a treatment for patients with diabetes and reflects Lilly's current belief. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

PP-DB-US-0697 1/2020Lilly USA, LLC 2020. All rights reserved.

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SOURCE Eli Lilly and Company

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Lilly plans donation of 200000 insulin KwikPens over next three years to support lower-income communities - P&T Community

Hitting the snooze button more? Having a lot of off days at the gym? If you exercise seven days a week without any rest, you might be exhibiting signs of overtraining. Trying to power through your workouts when you're not feeling right can sabotage your fitness goals and lead to more serious problems.

Both your mind and your body need a break from the gym.

Credit: John Fedele/Tetra images/GettyImages

Here, Geoff Tripp, CSCS, certified personal trainer and head of fitness at Trainiac, shares five reasons you shouldn't be working out every day, plus how often you should hit the gym for optimal results and overall health.

If you train without recovery days, you're likely to encounter a sharp decline in adaptation, or your body's ability to absorb the training load, Tripp says. When this happens, you'll usually experience exhaustion, weakness, and "excessive soreness that lingers for days," he says.

And when you feel like crap and can't perform your best, you're more prone to hurting yourself. Going beast mode 24/7 and not following a proper recovery protocol can result in overuse injuries like tendinitis or stress fractures, according to the Mayo Clinic.

What's more, pushing too hard all the time can also throw your hormones into chaos. Overtraining can lead to problems with your adrenal glands and hormonal imbalances that cause chronic fatigue, per a February 2013 review in the Journal of Novel Physiotherapies.

"Just like we can see a stall in physical adaptation, we can also see a slowing of weight loss due to overtraining," Tripp says. Exercise taxes your body, and working out too hard and too much can increase stress hormones like cortisol. And persistently elevated cortisol levels are associated with obesity and a larger waist circumference, according to a February 2017 study published in Obesity.

To make matters worse, chronic stress can increase your appetite and cravings for foods high in fat and sugar, according to Harvard Health Publishing. Conversely, some people may lose the desire to eat when overstressed due to overtraining, Tripp says. Under-eating forces your body to shift into conservation mode, he says. That is to say, it protects itself from starving, and, in doing so, stops weight loss in its tracks.

A big drop or steady decline in heart rate variability (HRV) is a telltale sign of stress that someone's been burning the fitness candle at both ends, Tripp says. HRV a measure of the variation in time between each heartbeat is regulated by the autonomic nervous system, which is responsible for the body's fight-or-flight and relaxation responses, according to Harvard Health Publishing.

An HRV on the low end which happens when you overtrain indicates that your system is operating in fight-or-flight state whereas a higher HRV signifies a more relaxed condition. In other words, when you regularly overdo it at the gym, your body's stress mode remains turned on. Prolonged stress can increase your risk for a range of health problems, from heart disease to digestive issues and cognitive impairment, per the Mayo Clinic.

Can't drag yourself off the couch? Lack of motivation is another big red flag when it comes to overtraining, Tripp says. Turns out, pushing yourself too much not only exhausts you physically, but also mentally and emotionally. In fact, overtraining has been associated with depressive feelings, according to a March 2012 review published in Sports Health.

"If you begin to experience sluggish workouts, general tiredness and little enthusiasm for exercise, it's time to take a few rest days or even a full week for recovery," Tripp says. "A recovery week can focus on light cardio activities, mobility activities, clean nutrition and sleep."

Struggling to roll out of bed in the morning? Sleep is essential for repairing, growing and strengthening your muscles. That's because working out especially weight-lifting creates microscopic tears in your muscles, and you need rest to heal and rebuild them.

"If you're experiencing restless sleep after a string of very active weeks, you could be teetering on the edge of overtraining," Tripp says. And, unfortunately, the stress that results from overdoing it at the gym isn't improving your sleep quality. Case in point, a November 2015 review in Sleep Science linked high levels of the stress hormone cortisol with insomnia.

That depends on your fitness level and health goals, Tripp says. The current Physical Activity Guidelines for Americans recommend at least 150 to 300 minutes a week of moderate-intensity cardio or 75 to 150 minutes a week of vigorous-intensity aerobic physical activity, plus muscle-strengthening activities of moderate or greater intensity two or more days a week.

But "rest days should be a part of everyone's weekly workout schedule too," Tripp says. "Generally, when you have an overtraining issue, it's a combination of too many intense efforts in a row and not enough easy days."

The main takeaway? Don't go full throttle every day, and when you do have a particularly tough sweat session, offset it with a rest day or active recovery. Go on an easy hike, take a yoga class or focus on breathing and meditation, Tripp says.

Always listen to your body. Everyone has off days, but if you feel like every workout is a struggle, it's time to take a break.

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Why You Shouldn't Work Out Every Day Without Rest Days - LIVESTRONG.COM

Got to lunchtime and suddenly realised you forgot to take your contraceptive pill this morning? Or worse, looked at the packet and realised you missed it yesterday too? If you're not planning on procreating any time soon, that sudden feeling of pregnancy panic and anxiety about what you should do next can be very real.

Missed pill advice can be pretty confusing, so Dr Juliet McGrattan is here to walk you through what you should do if you forget to take you contraceptive pill and when you might need emergency contraception.

Remember: if you arent using your pill for contraception and only take it to treat medical conditions such as heavy periods, then theres no need to worry, you can just take the pill youve missed and carry on as normal.

There are three factors that are important to take into consideration when it comes to missing a pill: what type of pill you are taking, when you last took your pill and where you are in your pill packet.

Containing a combination of oestrogen and progestogen, combined oral contraceptives (COCs) are the most common type of contraceptive pill. Theyre taken daily with scheduled breaks for withdrawal bleeds.

After 21 days of daily pills, the level of hormones in your system is enough to protect you from pregnancy during a seven-day break. Its easy to see how missing a pill and extending this break by forgetting one just before or in the first few days after the break could put you at risk of pregnancy.

Take the pill as soon as you realise youve missed it and carry on as normal. Dont change the timing of the next pill, it doesnt matter if you end up taking two close together. Theres no need for extra contraception, your hormone levels wont have dropped enough to put you at risk of pregnancy.

When youve missed two or more pills, the level of hormones may have dropped enough to put you at risk of pregnancy. Take the most recent pill youve missed and leave the others. Carry on taking your pills as normal but to avoid pregnancy, either avoid having sex or use another method of contraception such as condoms for seven days.

If you are due to have a pill break within these seven days, dont take the break, just go straight onto the next packet. Remember, if you use an everyday (ED) COC then you will need to miss out the inactive tablets in the pack and go on to a new packet starting with the active pills.

You may need emergency contraception so read on.

If youve missed two or more pills, then you might need emergency contraception if youve had unprotected sex within the last seven days and if any of the following applies:

Its important to take emergency contraception as soon after sex as possible. The most effective form is insertion of a copper intra-uterine device (IUD) into the uterus (womb) but there are also hormone tablets that can be taken to prevent pregnancy. No method is 100 per cent effective but the sooner it is taken, the better. You can access emergency contraception in a number of ways including through a Family Planning clinic, your GP, your pharmacist or a sexual health clinic.

There are certain COCs where missed pill advice is different. If you are taking any of the following COCs; Qlairia, Daylette, Zoely and Eloine. Please read the information sheet that comes with the pills and contact your doctor or family planning clinic for further advice.

The progestogen only pill (POP) only contain progestogen, theres no oestrogen in them. They are taken continuously without a break so there are no pill free days and you simply finish one packet and go straight on to the next.

POPs need to be taken at the same time every day for them to be effective. For most POPs, there is a three-hour window in which to take them, for POPs containing the progestogen called desogestrel, there is a 12-hour window.

Simply take the late pill and carry on as normal, theres no need to worry.

If you are more than three hours late (or more than 12 hours for desogestrel POPs) Take the most recent pill you have missed and carry on. Dont change the timing of the next pill, it doesnt matter if you end up taking two close together. You are at risk of pregnancy so you need to abstain from sex or use another method of contraception for two days. If you have unprotected sex during these two days you may need emergency contraception. See the advice above regarding this.

If you miss a pill, then dont bury your head in the sand. Prompt action and emergency contraception if necessary can prevent unplanned pregnancies. Read the instruction leaflet that comes with your pill packet and speak to your GP, practice nurse, family planning clinic, pharmacist or sexual health clinic if you need advice. You can also get advice and information on the Family Planning Association website.

For contraceptive pills to be effective you need to be a good pill taker. Some people find this easier than others. Here are some things you can try to make sure you dont miss pills in the future:

Find the best time of day for you to take your pill. For some women this is in the morning but for others the evening or at lunchtime is best.

Associate pill taking with something you do every day such as brushing your teeth or making a cup of tea.

Set a reminder on your phone.

Use a specific pill taking app to keep you on track, some will give you advice about missed pills too.

For further advice and information on contraception, try one of the following:

Last updated: 30-01-2020

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Missed contraceptive pill: what to do if you miss the combined contraceptive pill or the progestogen only pill - Netdoctor

If you have a confirmed testosterone deficiency, its important to identify if there are any reversible causes that can be addressed before committing to, what should be considered a lifelong therapy. Testosterone Replacement Therapy (TRT) is an involved process. In my professional opinion, the most effective method of replacement is daily Testosterone Cypionate and Human Chorionic Gonadotropin (HCG) injections. Your dose is carefully titrated to normalise your male androgen levels.

TRT is an involved process, its a financial commitment and its a time-consuming process. Two daily subcutaneous injections, admittedly with a tiny 29-gauge insulin needle, preparation of your multi-dose vial, every 3 months for Testosterone Cypionate and monthly for HCG, regular blood tests, additional blood tests after a protocol change. We have patients from all over the UK, Europe and further afield, they all have an initial face to face consultation and yearly thereafter, the rest can be managed remotely. Some of my patients travel thousands of miles, Denmark, Norway, Spain, Portugal, Dubai, the Philippines to ensure they receive Gold Standard care. Londoners often complain a trip to Poole is too far, little do they know.

TRT has traditionally been thought of as simply replacing the testosterone. It makes sense, replace the testosterone that is deficient. The issue lies with the subsequent negative effect on other important parameters administration of exogenous testosterone has on the body. Injecting testosterone shuts down the Hypo-pituitary Gonadal (HPG) axis, you know longer produce Lutenising Hormone (LH) and Follicle Stimulating Hormone (FSH) from the pituitary gland in the brain. LH stimulates the Leydig cells of the testes to produce testosterone, the FSH stimulates the Sertoli cells to produce sperm through a process called spermatogenesis.

HCG mimics LH, it is used in the treatment of male infertility. Intra-testicular testosterone is partly converted to oestradiol by the aromatase enzyme, this helps facilitate spermatogenesis. The Mens Health Clinic now has 20 pregnancies with the concurrent use of HCG alongside testosterone. Its important to appreciate that there are LH receptors all over the body, most noticeably the brain. HCG is clearly important to help maintain fertility and testicular size, but its effects are more wide ranging. Men report an improved sense of well-being and libido using HCG alongside testosterone.

I am uncomfortable with allowing an organ, in this case your testicles, to atrophy with testosterone monotherapy. It seems illogical to me that this should be accepted. I believe that irrespective of whether you want to conceive or not, you should replace this hormone. TRT should be considered hormone replacement therapy (HRT), we should be maintaining function with HCG and supplementing with testosterone to ensure your male androgen levels are normalised.

I am rather shocked and appalled that the medical community has such a simplistic approach to TRT, as one NHS Endocrinologist recently said to me either the patient wants to retain fertility in which case you offer HCG or they do not want to retain fertility in which case you treat with testosterone. This regressive and outdated attitude and approach to TRT is one of the reasons men are willing to travel from all over the world to The Mens Health Clinic, Gold Standard care.

More:
Testosterone Replacement Therapy or Hormone Replacement Therapy? - Reno Hotline

Stress is most definitely a mood killer and life stressors can hit us at any angle.

From relationship woes to financial troubles, illnesses, work and fatigue, finding the time and energy to focus on your body and partner in tandem could be the last thing on your mind.

Kate Moyle, a sex expert for LELO a company that specialises in pleasurable toys told The Express: Sex lives need nurturing. They won't just change or improve on their own. The couple needs to make a commitment to doing or trying something new together.

I often talk to couples about trying to change one thing each time that they have sex, and this could be as small as starting with clothes on or off, taking the bedding off and making a bed on the floor, lights on or lights off, trying a new position, using lubricant or not, introducing a sex toy, giving a massage - the list is endless.

READ MORE: How to sleep: Sniff this oil before bed to get a good nights sleep

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Low libido: Your daily life could be affecting your sex drive - how to increase libido - Express

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If youve been in a romantic relationship, youre probably used to holding hands. Whether youre walking together or sitting down to relax, its a nice experience.

But aside from being a natural, romantic activity for couples, holding hands strengthen your emotional connection too. Theres a good reason for this too.

According to Silva Neaves, psychosexual and relationship psychotherapist, when you hold the hand of someone you love, your breathing starts to sync up with the person youre with. She also revealed that emotions will flow from one person to the other.

Speaking to Cosmopolitan, she said, It appears that holding hands serves the purpose to feel a deepening in human connections.

In addition to this, Silva said, Many studies in neuroscience show that touch produces oxytocin, a feel-good chemical that is very good for your mental and physical health.

Credit: Getty Images

Oxytocin is a hormone that promotes bonding, connection, empathy and trust, and is also the hormone that is released during sex. Our hands are one of the most sensitive parts of our bodies, so it makes sense that theres a deep emotional connection when you hold the hand of someone you love.

Dr Becky Spelman from Private Therapy Clinic added that holding hands means we can instinctively interpret the other persons anxiety or comfort levels. We can do this by feeling how much theyre sweating, their pulse, and the strength of their grip.

Hand holding is also a learned behaviour, as Dr Spelman points out that babies are born with a grasping reflex and will curl their tiny hands around any finger placed in their palm.

The act of hand holding is associated with safety too, as parents hold childrens hands to keep them safe when crossing the road. Childhood behaviours can transfer to romantic relationships later in life, so it makes sense that hand holding is considered intimate when were in relationships.

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This is why holding hands with your partner deepens your bond - goodtoknow

On Thurs Jan 23, University of Toronto professor of psychiatry Dr. Ken Zucker, a leading international expert on gender dysphoria, and editor-in-chief of Archives of Sexual Behaviour, spoke at McGill University. Dr. Zuckers presentation was titled, Children and Adolescents with Gender Dysphoria: Some contemporary research and clinical issues.

Inviting Dr. Zucker to speak in an open forum was an act of courage, as he is Canadas most controversial researcher/clinician in this domain. In a recent column for the National Post on the run-up to this event, I summarized the story of his persecution by hostile trans activists and linked to a more detailed account.

Dr. Zuckers critics accuse him of practicing conversion therapy, by which they mean his objective is to prevent his patients from transitioning. But what Dr. Zucker actually practices, as he explained to me in an interview, is Developmentally Informed Psychotherapy.

In laymans terms, Dr. Zucker looks at his patients holistically in order to determine if the distress that brought them to his attention is a function of gender dysphoria alone, or gender dysphoria as one of a number of factors, including issues arising out of family dynamics, autism spectrum disorder, depression, anxiety and so on. If in the course of treatment, it becomes clear that finding comfort in his or her natal sex is a reasonable goal for the client, Dr. Zucker offers guidance to that objective. If it becomes clear that only transition will answer to the patients need, Dr. Zucker endorses transition, and puberty blockers or hormone therapy as required.

But any form of traditional psychotherapy is considered to be a form of subversion by many trans activists because trans activists reject assumptions that gender dysphoria is a disorder or even a distress requiring psychotherapy. Their watchword is affirmation, the assumption that if a young child even as young as three says he or she wants to change genders, they know what they want and their wish must be respected, often without any further exploration at all before social transition is encouraged.

Watchful waitingwithholding immediate affirmation, giving the childs parents and professional observers time to assess the depth and putative permanence of the expressed desireis also anathema to a small, but vocal group of trans advocates. To these activists, Dr. Zuckers perspective is superannuated, offensive and, in their discourse, harmful. It was a given that the announcement of the event would spark protest. It was just a matter of what kind, and how obstructive it would be.

The presentation was sponsored by the Culture, Mind and Brain Program, a subdivision of McGills Division of Social and Transcultural Psychiatry. Assistant professor of psychiatry Samuel Veissire, co-director of the program, who headed up the organizing team for the talk, was fully cognizant of the tension that would surround it, and did a great deal of spadework in reaching out to stakeholding organizations like Queer McGill, expressing sympathy for their concerns and soliciting their attendance.

Some individuals from these groups did attend, although McGill Equitys Subcommittee on Queer People preferred to hold their own alternative positive space for trans and non-binary students, staff and faculty (and their allies) who would feel the need to gather and be together in solidarity[with] snacks, tea and hot chocolate [provided].

The important thing is that protest was carried out on Facebook pages calling for boycotts of the event, and letters to the administration asking for cancellation (the administration did not waver in the face of this pressure, to their credit), rather than in attempts to physically inhibit, or even shout down the speaker. In fact, not a single active protester showed up at the lecture site in McGills Neurological Institute-Hospital (the Neuro), and those who came to the lecture itself with a view to challenging Dr. Zucker, listened respectfully, calmly voicing their disagreements with him in the extended Q&A. That in itself is a triumph in these days of cancel culture and a tribute to the organizers and to the maturity of the opposition.

A trans-advocacy mantra one continually hears from those protesting the scholarship of Dr. Zucker and others with his perspective is nothing about us without us. That is, trans advocates believe they have the right to participate in any public forum on this subject, because science, they rightly observe, is never entirely neutral, and has often been exploited to uphold societal values, notably in the case of homosexuality, which was only depathologized in medical texts mere decades ago.

They are understandably defensive about research, however sound by objective standards, that might be driven by unconscious bias. Whether that suspicion confers a right to insert representation of their own belief system into all public forums in which opposing views are featured is debatable, to say the least. Practically speaking, if that were the rule, scholars like Dr. Zucker would find their time slots so reduced in length as to trivialize their contribution.

Prof Veissire addressed these concerns with exquisite delicacy and eloquence in his introductory remarks to the full lecture room:

Two key issues in particular strike me as exceptionally important. These two issues are in fact questions. They are questions about neutrality and advocacy, on the one hand, and questions about who can speak for whom on the other In recognition of past and ongoing medical injustice, I want to proposespeaking from my own perspective herethat the relevant point here is not so much that science cannot be neutral, but that it shouldnt be.

I speak as an anthropologist and cognitive scientist now, as one who is committed to documenting and honouringa set of core values found in absolutely all cultures.These are the values ofcharityfor those in need,hospitalityto those different from us, and commitmentto the greater human good.Charity and hospitality also teach us to engage inforgiveness andreconciliation.These core values are often translated and lived in traditions ofloving-kindness..

Given its long and ongoing history of marginalization, the trans community can often feel excluded and harmed when conversationsabout themare taking placewithout them.We all need to listen to this point and learn from it.Similarly, when some parents who are doing their best to help their gender-nonconforming child live a good life tell us they feel excluded from the current conversation when they want to ask more questions, we need to listen and learn.When individuals for whom transition didnt work tell us they feel excluded from this conversation, we need to listen and learn.

This is what I want to invite you all to do together today. Listen to and learn from each othersdiverse perspectives and experiences in the spirit of loving kindness and democracy.

Tucked in between the statistics, graphs and pie charts of his PowerPoint, Dr. Zucker made allusion to certain trigger points. One is the widely acknowledged fact in the non-trans academic community that most effeminate little boys are not gender dysphoric, but gay. These desistors children whose gender preference may be ambiguous in childhood, but who after puberty revert to comfort in their natal sex, albeit with same-sex preference, present a difficulty for trans advocates. Were they really trans to begin with, if they can revert? This begs the question of what it means to know you are in the wrong body. In his somewhat puckish manner, Dr. Zucker slipped in some zingers. Noting the disappearance of the butch lesbian, Dr. Zucker asked, Is trans the new tomboy?

Another hot button in the clash between unconditional affirmers and watchful waiters is the looming shadow of suicidality. Better a trans kid than a dead kid is a frequently adduced trans credo. Here Dr. Zucker pointed out problems in methodology with the various alarmist suicidality studies. Some predictors of suicidal ideation, he said, were general behavioural problems and, for example, being female in a single-parent family. Adolescents with gender dysphoria that are referred for treatment do indeed demonstrate higher rates of suicidality, but then so do non-trans kids who are referred for other problems. This is an area that needs more research and more control groups, he said.

Rapid Onset Gender DysphoriaROGDis the most divisive and controversial issue in the debate. The cynosure for trans advocates anger is a study on ROGD published by researcher Lisa Littman of Brown University on PLOS ONE, the most downloaded study in that journals history. It suggests that for many teenage girls (the great majority of ROGD subjects), identifying as trans is a maladaptive coping mechanism for girls suffering from other problems, and its startling escalation expressive of a social contagion. Dr. Zucker alluded to the reception of the report by trans advocates as an attack on trans people and a debunked right-wing conspiracy theory.

(Full disclosure: I have met with many of the parents cited in the Littman study as part of my work. The accusations against them by hostile trans activists are absurd and defamatory. Those I met are loving parents, tortured by their childrens sudden conversion and withdrawal from thema strategy promoted on the websites they are obsessed withand desperate to help them achieve mental and psychological stability. They are neither politicized nor biased against homosexuality or gender dysphoria. The Littman study, in my opinion, is responsibly conceived and executed, persuasive and grounded entirely in good-faith efforts to understand an unprecedented social phenomenon.)

The ROGD debate hinges on treatment. In The Netherlands, Dr. Zucker noted, the Dutch do longer assessments before prescribing blockers or HRT, so treatment may only begin two years after referral. In Canada, you can be prescribed blockers after 15 minutes. Theres food for thought there, no matter what side of the debate you are on.

The Q & A was intense but restrained.

Standouts: a young woman, a detransitioner who had stopped taking hormones and wished to live in accordance with her biology, spoke quietly and sadly about her experience of being encouraged into hormonal transitioning by therapists in spite of a history of depression. She had experienced suicidal ideation as a result of her experience. She believes therapists should insist that anyone with depression be treated primarily for that, only secondarily for gender dysphoria.

Literally and figuratively on the other side of the room, a young transman countered with I was mentally ill and also trans, declaring that if it were not for rapid affirmation and treatment, he would have committed suicide. Dr. Zucker responded that in his opinion an individual is not getting good quality care if she or he is not treated holistically. He noted, however, that some advocates are arguing that mental health people should no longer be involved in the transition process altogether.

Thats worrisome for those of us opposed to radical trans solipsism, because what is argued for today may well be public policy tomorrow. After all, conversion therapy is illegal in some provinces already, and a Senate Bill (S-260), presently in first reading, seeks to have it included in the Criminal Code.

Many of the attendees were academics in this domain. Prof Veissires was gratified in particular that a leading trans positive researcher in the field from the Universit de Montral had not only attended, but engaged in a collegial discussion with Dr. Zucker during the Q & A, and afterward. This was precisely the form of reconciliation he was seeking to encourage.

One student spoke to the freedom of speech issue, arguing that even if people feel harmed, higher education institutions exist to accomplish goals that override the putative right not to be offended. Universities must deliberate all sides of issues, so that later we arent flailing making policy decisions. The Neuro, he pointed out, is not only a learning institution but a clinic that aims to relieve actual harms and sufferings. Theres a cost/benefit analysis to be done.

As you see, the mixed audience raised a gamut of difficult questions, and I think all present felt their minds were stretched in a positive way by the need to juggle their own settled opinions with opinions they do not normally hear in their academic and social silos. Was the young transman harmed by hearing the point of the view of the detransitioning woman? Were the many trans allies present harmed by the opinion that freedom of speech in universities should take precedence over the wish not to be offended? I saw no evidence of that, and I hope all those present would agree that the space was safe for everyone.

If you have read this far, I congratulate you on your stamina and thank you for your patience. I have gone on at such length, because although McGills administration stood fast on this invitation, I have seen enough of the correspondence around the event between and amongst trans stakeholders in the McGill community to fear that wheels have been set in motion with a view to formal internal roadblocks that would preclude further invitations to speakers whose views do not align with those of gender-fluidity theorists. I therefore wanted to be on record in a detailed way as a witness to the success of the program.

Two attendees referred to Dr. Zuckers presence as provocative. The logic in applying the word provocative is circular. Basically, it means, We, trans advocates and allies, do not approve of Dr. Zuckers findings or conclusions or clinical principles because some of them conflict with our preferred understanding of the phenomenon of gender dysphoria. We cannot prove that our findings are more scientifically viable than his, but since his are offensive to us, they must be provocative in general.

This is the Humpty-Dumpty school of rhetoric. It is professionally feckless, not to mention an unworthy smear of Prof Veissire, whose compassion for gender-dysphoric people is palpable, and whose invitation to an ultra-accredited colleague to speak on the issue was issued in good faith.

Moreover, there is debate within the trans community itself overdiagnosis and treatment, and many non-ideological trans people find such provocative opinions as Dr. Zuckers both reasonable and admirable. Where childrens interests are at stake, the precautionary principle should never be considered offensive. Provocative should be reserved for hatemongers, or speakers of dubious accreditation in spouting demonstrably fallacious theories (an accusation often directed at gender theorists themselves, but without attempts to de-platform them on that account).

Beyond suggesting that Dr. Zuckers ideas are both wrong and dangerous, there is a further dimension to the word provocative that I think most people outside the trans movement find disturbing.

The trans movement has worked very hard to normalize the concept of gender fluidity. Transgenderism is often wrongly conflated with homosexuality. But living happily gay does not involve bodily changes, lifelong medication or surgery to produce psychological comfort with ones biology or gender.

As a consequence of accepting that gender transitioning is normal, however, one must accept easy and immediate affirmation, and everything that goes with itpuberty blockers, cross-sex hormones, surgeries, infertilityas normal too. If society, in general, accepts this premise, then parents who wish to slow down this allegedly normal process may legitimately be labelled obstructive. Their stubbornness in resisting rapid affirmation may be labelled provocative as well.

As a result, prudent and protective parentswhat I would call normal parents are often positioned as enemies of the childand their status as enemies is often communicated to the child. The isolated child finds a new family amongst the many trans allies only too happy to welcome him or her into the fold. The distress of parents caught up in this Kafkaesque nightmare, as I learned firsthand from interviewing parents of ROGD teenagers, cannot be overstated.

Observers in the public are extremely uneasy about this situation. They know very well that true gender dysphoria is quite rare. But they also know that in the present cultural climate, it is increasingly difficult to find a therapist or educator who does not recommend instant affirmation. They feel they will be vilified for stating the obvious in what they wish for their children.

They know, and so do we all that: it is preferable to be comfortable in your own body than uncomfortable; it is preferable to expend ones mental energies on the world around one than to be constantly mentally consumed by ones gender identity; it is preferable to live a life free of daily hormone ingestion and not at risk for their negative side effects than to be condemned to a lifetime of them; it is preferable to know that having children or not will be an informed adult choice than a choice made for you when you are incompetent to understand its ramifications; it is preferable to live life in a whole body than in a mutilated one; it is preferable to have uncomplicated sexual relations as an adult than complicated.

All parents want to see their children following the path of least resistance to health and happiness. Thus, all these statements being so evidently true, they ought to be considered banal. But todaybecause it is provocative they must not voice these banalities. They are afraid, reasonably so, that they will be labelled transphobic.

Sadly, we now see parents who pretend for the sake of wokeness that it is a matter of indifference to them whether their child is comfortable in his or her natal sex or prefers to transition. We even see parents who establish an artificial environment of gender neutrality to create a level playing field between the two outcomes. They win fawning plaudits from a vocal band of activists, but the silent majority of people are appalled by such social engineering, the use of ones own children as gender-theory lab rats

This is why many of those who can afford to turn to Dr. Zucker for guidance when their children show signs of gender confusion, which may be transient or early evidence of homosexuality, or which may be signs of genuine and permanent self-identification as the opposite sex. They know he will allow them to express their preference and their fears without judgment, but if it turns out to be necessary, will help them to accept what they fear with empathy.

I walked down the mountain from The Neuro to Sherbrooke St with Dr. Zucker after the event, and we held an informal post mortem of it. That it was not cancelled was in his eyes a good outcome.

We both mused on the strangeness of trans activists demands that they be part of every presentation regarding gender dysphoria. Their slogan, nothing about us without us suggests that researchers are talking about them as individuals rather than the phenomenon of gender dysphoria. To my mind, theres a certain narcissism in such an absurd implication. Anorexics do not demand to be given equal time with anorexia researchers in the public forum. Neither do people with Autism Spectrum Disorder, even though in the past science was not particularly kind to them either.

Dr. Zucker treats children from toddlerhood on. Exploration of all contributing factors is extensive and as leisurely as necessary. He says occasionally a therapeutic breakthrough can turn on a dime. In one case, as an example, the underlying issue for the girl a natal female expressing the wish to transition to male was a conflict with her abusive father. Her epiphany came one day when Dr. Zucker asked her, If you are afraid of your father, why do you want to be the same gender as he is? This brought her up short, he said, and she was silent. The next day, she told him she had decided she wanted to remain a girl.

I asked him how many of his patients resolved their distress without a need for transitioning, and ended up identifying with their natal sex. As if he knew that question was cominghe surely must have knownDr. Zucker briskly replied, eighty-eight percent. It is probably just as well that the question and the provocative answer did not arise in the Q&A.

See the rest here:
Convicted sex predator of young children to be released for being trans - The Post Millennial

Shift workers comprise more than 15% of the U.S. workforce, with 10% demonstrating shift work sleep disorder (SWSD). SWSD is a circadian rhythm disorder caused by a reduction of total sleep time due to a work schedule and has been found to be associated with hypogonadism in men.1 Pastuszak et al. had previously provided the foundation for this research, identifying that non-standard shift workers with poor sleep quality were at increased risk for hypogonadal symptoms and sexual dysfunction.2

In this present study, Balasubramanian et al. surveyed men presenting to a single academic mens health clinic between July 2014 and June 2017. The administered research instruments included questionnaires about work schedules, a validated SWSD screening questionnaire and validated questionnaires such as the Androgen Deficiency in Aging Males (ADAM) and non-validated quantitative Androgen Deficiency in Aging Males (qADAM) questionnaires. Ultimately, the authors found that males working non-standard shifts with a high risk for SWSD had worse hypogonadal symptoms and lower testosterone levels compared to daytime workers and non-standard shift workers with low risk for SWSD.The authors provide important insights into the emerging relationship between sleep quality and hypogonadism. Separate studies assessing the impact of obstructive sleep apnea and sleep restriction on testosterone levels have been performed, similarly concluding that poor sleep quality is associated with hypogonadal symptoms.3,4 While the mechanism between sleep quality and hypogonadism is not completely understood, it is evident that further research into this relationship is critical for optimizing the care for patients with SWSD and hypogonadal symptoms. As sleep is increasingly recognized as a determinant of overall health, future work will continue to define the role of sleep habit modification in the management of men with hypogonadal symptoms, particularly amongst those who may be considered ineligible for testosterone therapy based on current American Urological Association (AUA) guidelines.

Written by: Eric M. Lo, Adithya Balasubramanian, LarryI. Lipshultz, Baylor College of Medicine, Houston, Texas, USA.

References:

Excerpt from:
Increased Risk of Hypogonadal Symptoms in Shift Workers with Shift Work Sleep Disorder - Beyond the Abstract - UroToday

Hypothyroidism, hyperglycemia, and low adrenocorticotrophic hormone (ACTH) levels are associated with lower bone mass in patients with thalassemia major, according to study results published in The Journal of Clinical Endocrinology & Metabolism.

The major mechanisms of endocrine dysfunction that lead to decreased bone mineral density (BMD) and increased risk for fracture in patients with thalassemia major remain poorly understood. Researchers aimed to identify the mineral and hormonal factors associated with low BMD in adults with -thalassemia major in a retrospective study of patients who received treatment at the National Taiwan University Hospital (ClinicalTrials.gov Identifier: NCT03951818).

Medical history was obtained for 29 patients (51.7% women), including bone-associated biochemical markers such as serum calcium, phosphorus, intact parathyroid hormone, vitamin D, and fibroblast growth factor 23 levels. Pituitary function and thyroid hormone levels were used as a proxy for endocrine function. BMD was measured using dual-energy x-ray absorptiometry. Expected height was calculated for each individual based on parental height from patient records.

The mean observed height across all patients was lower than expected (women, -3.7 cm; men, -7.3 cm). Abnormal BMD, defined as a z score 2 standard deviations away from normal BMD, was observed in 42.9% of women and 23.1% of men. In addition, 26.7% of women and 35.7% of men had a history of fracture. Vitamin D deficiency (women, 100%; men, 81.8%), hypogonadism (women, 60%; men, 57.1%), and growth hormone deficiency (women, 75%; men, 57.1%) were highly prevalent in the study group.

Several factors were associated with either femoral neck or lumbar spine BMD, but only thyroid status and lower ACTH levels correlated with BMD at both sites (P <.05). Along with thyroid status (P =.016) and ACTH levels (P =.005), glycated hemoglobin levels (P =.039) were significantly different in patients with normal vs abnormal BMD. When included in a multivariate regression model adjusted for ferritin level, age, and sex, however, hypothyroidism was the only factor significantly associated with lower femoral neck BMD (P =.034). Patients with hypothyroidism had lower BMD at both the lumbar spine (P =.024) and femoral neck (P =.004). No association was found with fracture risk.

Our study is the first study to review the complete endocrine and mineral profiles to identify factors related to the severity of decreased BMD in patients with [thalassemia major], the researchers noted. We found that hypothyroidism and hyperglycemia were the most relevant factors of lower bone mass, while ACTH had a protective role.

The researchers also noted that the interplay between these factors supports the idea that iron overload may be a driver of decreased bone mass in patients with thalassemia major.

Based on these findings, it is promising to conduct interventional trials in the future that evaluate the effect of treating hypothyroidism or glycemic control on BMD and the risk of fracture in patients with [thalassemia major], the researchers concluded.

Reference

Yang WP, Chang HH, Li HY, et al. Iron overload associated endocrine dysfunction leading to lower bone mineral density in thalassemia major [published online January 7, 2020]. J Clin Endocrinol Metab. doi:10.1210/clinem/dgz309

This article originally appeared on Endocrinology Advisor

The rest is here:
Mineral, Hormonal Dysfunction Associated With Lower BMD in Thalassemia Major - Rheumatology Advisor

GlobalHormone Replacement Therapy (HRT)Market study of 118+ data Tables, Pie Chat, Graphs & Figures spread through Pages and easy to understand in depth analysis. Hormone Replacement Therapy (HRT) Market by Type(Oral, Parenteral, Transdermal, Others),by Application(Menopause, Hypothyroidism, Male Hypogonadism, Growth Hormone Deficiency, Others)and Region Forecast and Status to 2026. At present, the market is developing its presence. The Research assessment of the Market contains a historical trend, current growth factors with opinions view & industry certified market details. The research study provides estimates for Global Hormone Replacement Therapy (HRT) Forecast till 2026*. The report provides key statistics on the market status of the leading market players and offers key trends and opportunities in the Hormone Replacement Therapy (HRT) Market.The major players covered in Hormone Replacement Therapy (HRT) areAbbott Laboratories, Novartis, Pfizer, Mylan Laboratories, Merck & Co., Amgen, Novo Nordisk, Bayer, Eli Lily, Wyeth, Genentechand others.

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computation of The Hormone Replacement Therapy (HRT) Market:

Global Hormone Replacement Therapy (HRT) Market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2025, growing at a CAGR of XX% during the period 2019 to 2025.Hormone Replacement Therapy (HRT) market report examines the short-and medium-term economic and profitability outlook for Hormone Replacement Therapy (HRT) industry.. A comprehensive research report created through extensive primary research (inputs from industry experts, companies, stakeholders) and secondary research, the report aims to present the analysis of Hormone Replacement Therapy (HRT) Market.

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The study objectives of Hormone Replacement Therapy (HRT) Market:1) This report discusses the market summary & market scope gives a brief outline of the Market.2) Clear information for market players to sustain and enhance their market footprint.3) Analysis of various perspectives of the market with the help of SWOT analysis & Porters five forces analysis.4) Focused Hormone Replacement Therapy (HRT) Market Production, Consumption, Export, Import by Regions.5) Geographic breakdown Historical, current and projected market size in terms of value.6) A neutral perspective towards market performance.

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Browse full report @https://www.industryandresearch.com/report/Hormone-Replacement-TherapyHRTMarket-by-Type-Oral-Parenteral-Transdermal-OthersApplication-Menopause-Hypothyroidism-Male-Hypogonadism-Growth-Hormone-Deficiency-OthersGlobal-Insights-Trends-and-Forecast-2012-2024/162230

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Global Hormone Replacement Therapy (HRT) Market: Industry Analysis and Forecast (2020-2026) - NY Telecast 99

Ghaziabad, Jan 23 (IANS) Galactorrhea, in which a whitish or greenish discharge occurs from the nipples, affects nearly 24 per cent of women but has no association with breast cancer, health experts said on Thursday.

Galactorrhea is a milky nipple discharge unrelated to the normal milk production for breastfeeding. It is not a disease itself but could be a sign of an underlying problem. It usually occurs in women, even those who have never had children or after menopause.

According to the doctors at Columbia Asia Hospital in Ghaziabad, pre-menopausal women who are not breastfeeding may experience a condition where they produce breast milk.

The condition may indicate high levels of the hormone prolactin in the body, caused mainly by some malfunction in the pituitary gland that produces the hormone, the experts said.

Galactorrhea may occur when your body produces too much prolactin, (a hormone produced by the pituitary gland in the brain that stimulates the production of milk when a woman has a baby). Any woman who has had a baby, whether or not she breast-fed her baby, may later have galactorrhea, said Vinita Diwakar, Obstetrics and Gynaecology department, Columbia Asia Hospital.

Too much estrogen in the body due to birth control pills or an underactive thyroid gland can also cause the condition. Nipple stimulation due to sexual activity or sports activities such as jogging, can also increase prolactin production, Diwakar added.

According to the hospital, some of the other causes of galactorrhea may include consumption of drugs, such as oral contraceptive pills, some high blood pressure medications, sedatives and antidepressants; disorders or non-cancerous tumours of the pituitary gland; opivid use violactinoma other medical conditions such as kidney failure, cirrhosis of the liver, and tumours of the spinal cord.

If the breast tissue is particularly sensitive to prolactin in blood, it may cause idiopathic galactorrhea the reason for which remains unknown.

In men, galactorrhea may cause testosterone deficiency or male hypogonadism and usually occurs with breast enlargement or tenderness (gynecomastia). It may also cause erectile dysfunction and a lack of sexual desire due to testosterone deficiency, Diwakar said.

If a woman experiences a mild idiopathic galactorrhea, a tight breast support may help stop the discharge by preventing stimulation of the nipples, the doctor said.

In newborns, galactorrhea may be caused due to high maternal estrogen levels that cross the placenta and reaches the babys blood. This can enlarge the babys breast tissue, which may be associated with a milky nipple discharge, though it is temporary and resolves on its own. If the discharge is persistent, consult a doctor, Diwakar stressed.

See more here:
Galactorrhea affects 24% women, not linked to breast cancer - The Sentinel Assam

This weeks Round-up looks to the future, as nanoparticles and stem cell-derived cardiac muscle cells get a closer look. More good news for lovers of yogurt, and a smelly but effective treatment for atherosclerosis as well.

Using stem cells extracted from the patients own blood and skin cells, this Japanese research team completed the first-in-human transplant of cardiac muscle cells derived from pluripotent stem cells. The team achieved this by reprogramming them, reverting them to their embryonic-like pluripotent initial state. I hope that (the transplant) will become a medical technology that will save as many people as possible, as Ive seen many lives that I couldnt save, Yoshiki Sawa, a professor in the Osaka University cardiovascular surgery unit, said in apress report.

Stem Cell-Derived Heart Muscle Transplanted Into Human for First Time: Researchers

Like something from a sci-fi horror novel, this team of researcher examined the role that nanoparticles that eat dead cells and stabilize atherosclerotic plaque may be able to play in the future of atherosclerosis treatment. We found we could stimulate the macrophages to selectively eat dead and dying cells these inflammatory cells are precursor cells toatherosclerosis that are part of the cause of heart attacks, one of the authors said in press release. We could deliver a small molecule inside the macrophages to tell them to begin eating again. The authors noted that after a single-cell RNA sequencing analysis, they observed that the prophagocytic nanotubes decreased inflammatory gene expression linked to cytokine and chemokine pathways in lesional macrophages, thereby treating the cell from the inside out.

Are Nanoparticles Potential Gamechangers for Treating Clogged Arteries?

In this large analysis of more than 120,000 individuals, the authors reported multivariable-adjusted hazard ratios (95% CI for all) for mortality were reduced in regular (more than four servings per week) consumers of yogurt, and there was an inverse relationship between regular consumption and cancer mortality as well as cardiovascular-related mortality in women. In our study, regular yogurt consumption was related to lower mortality risk among women, the authors wrote. Given that no clear doseresponse relation was apparent, this result must be interpreted with caution.

Yogurt Consumption Associated with Reduced Mortality Risk (Plus a Caveat)

This research teamlooked human microphages and compared them to dying cells in a dish. They observed that macrophages reclaim arginine and other amino acids when they eat dead cells, and then use an enzyme to convert arginine to putrescine. The putrescine, in return, activates a protein (Rac1) that causes the macrophage to eat more dead cells, suggesting to the authors that the problem of atherosclerosis may be, in part, a problem of putrescine. The findings, according to the accompanying press release, suggest that the compound could be use to potentially treat conditions with chronic inflammation, such as Alzheimers disease.

The Nose Knows: Pungent Compound Associated with Improvements in Atherosclerotic Plaque

Excerpt from:
Cardio Round-up: Nanoparticles and Stem Cells in the Spotlight - DocWire News

A team of researchers at Osaka University in Japan successfully transplanted cardiac muscle cells created from iPS into a patient, who is now recovering in the general ward of the hospital.

The team, led by Yoshiki Sawa, a professor in the university's cardiovascular surgery unit, created the cardiac muscle cells from iPS cells in a clinical trial to verify the safety and efficacy of this type of procedure. The researches want to transplant heart muscle cells into ten patients who have serious heart malfunctions because of ischemic cardiomyopathy over a three year period.

RELATED: RESEARCHERS ORGANIZE STEM CELLS BASED ON A COMPUTATIONAL MODEL

Instead of replacing the heart of patients, the researchers developed degradable sheets of heart muscle cells that were placed on the damaged areas of the heart.

To grow the heart muscle cells in the lab, the researchers turned to induced pluripotent stem cells otherwise known as iPS. Researchers are able to take those iPS cells and make them into any cell they want. In this case, it was heart muscle cells.If the clinical trials prove successful it could remove someday the need for heart transplants.

I hope that (the transplant) will become a medical technology that will save as many people as possible, as Ive seen many lives that I couldnt save, Sawa was quoted at a news conference reported the Japan Times.

As for the patient, the team plans to monitor him during the next year to ascertain how the heart muscle cells perform. According to the Japan Times, the researchers opted to conduct a clinical trial instead of a clinical study because they want approval from Japan's health ministry for clinical application as soon as possible.

The report noted that during the trial the researchers will look at risks, probabilities of cancer and the efficacy of transplanting 100 million cells for each patient that could include tumor cells.

Continued here:
Heart Muscle Cells Made in the Lab Successfully Transplanted into Patient - Interesting Engineering

In what is a world-first and potentially the dawn of a new medical technology to treat damaged hearts, scientists in Japan have succeeded in transplanting lab-grown heart cells into a human patient for the first time ever. The procedure is part of a cutting-edge clinical trial hoped to open up new avenues in regenerative medicine, with the treatment to be given to a further nine patients over the coming years.

The clinical trial harnesses the incredible potential of induced pluripotent stem cells (IPSCs), a Nobel Prize-winning technology developed at Kyoto University in 2006. These are created by first harvesting cells from donor tissues and returning them to their immature state by exposing them to a virus. From there, they can develop into essentially any cell type in the body.

Professor Yoshiki Sawa is a cardiac surgeon at Osaka University in Japan, who has been developing a technique to turn IPSCs into sheets of 100 million heart muscle cells, which can be grafted onto the heart to promote regeneration of damaged muscles. This was first tested on pigs and was shown to improve organ function, which led Japans health ministry to conditionally approve a research plan involving human subjects.

The first transplantation of these cells is a huge milestone for the researchers, with the operation taking place earlier this month and the patient now recovering in the general ward of the hospital. The sheets are biodegradable, and once implanted on the surface of the heart are designed to release growth factors that encourage new formation of healthy vessels and boost cardiac function.

The team will continue to monitor the first patient over the coming year, and over the next three years aims to carry out the procedure on a total of 10 patients suffering from ischemic cardiomyopathy, a condition caused by a heart attack or coronary disease that has left the muscles severely weakened.

I hope that [the transplant] will become a medical technology that will save as many people as possible, as Ive seen many lives that I couldnt save, Sawa said at a news conference on Tuesday, according to The Japan Times.

Source: The Japan Times

Excerpt from:
Lab-grown heart cells implanted into human patient for the first time - New Atlas

Three-dimensional printers have now assembled candy, clothing, and even mouse ovaries. But in the next decade, specialized bioprinters could begin to build functioning human organs in space. It turns out, the minimal gravity conditions in space may provide a more ideal environment for building organs than gravity-heavy Earth.

If successful, space-printed organs could help to shorten transplant waitlists and even eliminate organ rejection. Though they still have a long way to go, researchers at the International Space Station (ISS) hope to eventually assemble organs from adult human cells, including stem cells.

The medical field has only recently embraced 3D printing in general, particularly in biomedical fields like regenerative medicine and prosthetics. So far, these printers have produced early versions of blood vessels, bones, and different types of living tissue by churning out repeated layers of bioinka substance comprised of living human cells and other tissue thats meant to mimic the natural environment that surrounds growing organs.

Recently, researchers are finding that Earth might not be the best environment for growing freestanding organs. Because gravity is constantly pushing down on these delicate structures as they grow, researchers must surround the tissues in scaffolding, which can often debilitate the delicate veins and blood vessels and prevent the soon-to-be organs from growing and functioning properly. Within microgravity, however, soft tissues hold their shape naturally, without the need for surrounding supportan observation thats driven researchers to space.

And one manufacturing lab based in Indiana thinks its tech could play a key role in space. The 3D BioFabrication Facility (BFF) is a specialized 3D printer that uses bioink to build layers several times thinner than human hair. It cost about $7 million to build and employs the smallest print tips in existence.

The brainchild of spaceflight equipment developer Techshot and 3D printer manufacturer nScrypt, the BFF headed to the ISS in July 2019 aboard the SpaceX CRS-18.

Currently, the project focuses on building increasingly thick artificial cardiac tissue and delivering it back to Earth. Once the printed cardiac tissue reaches a certain thickness, it gets harder for researchers to ensure that a printed structures layers effectively grow into one another. Ultimately, though, theyd like the organs to arrive here fully formed.

Printed organs would eventually require vasculature and nerve endings to work properly, though that technology doesnt yet exist.

The next stagetesting heart patches under microscopes and within animalscould span over the next four years. As for whole organs, Techshot claims it plans to begin production after 2025. For now, the project is still in its infancy.

If you were to look at what we printed, it looks very modest, says Techshot vice president of corporate advancement Rich Boling. Its just a cuboid-type shape, this rectangular box. Were just trying to get cells to grow one layer into the next.

Cooking organs like pancakes

Compare the manufacturing process to cooking pancakes, Boling says. The space crew first creates a custom bioink pancake mix with the cells sent from Earth, which they load with syringe-like tools into the BFF.

Researchers then insert a cassette into the BFF containing a bioreactora system that mimics the normal bodily functions essential for growing healthy tissue, like providing nutrients and flushing out waste.

Approximately 200 miles below in Greenville, Indiana, Techshot engineers connect with ISS astronauts on a NASA-enabled secure digital pathway. The linkup allows Techshot to remotely command BFF functions like pump pressure, internal temperature, lighting, and print speed.

Next, the actual printing process occurs within the bioreactor and can take anywhere from moments to hours, depending on the shapes complexity. In the final production step, the cell-culturing ADvanced Space Experiment Processor (ADSEP) cooks the theoretical pancake; essentially, the ADSEP toughens up the printed tissue for its journey back to earth. This step could take anywhere from 12 to 45 days for different tissue types. When completed and hardened, the structure heads home.

The researchers have gone through three testing processes so far, each one getting more exact. This March, theyll begin the third round of experiments.

The bioprinter space race

The BFF lab is the sole team developing this specific type of microgravity bioprinter, Boling says. Theyre not the only ones looking to print human organs in space, though.

A Russian project has also entered the bioprinting space race, however their technique highly differs. Unlike the BFFs bioink layering method, Russian biotechnology laboratory 3D Bioprinting Solutions uses magnetic nanoparticles to produce tissue. An electromagnet creates a magnetic field in which levitating tissue forms the desired structuretechnology that appears ripped from the pages of a sci-fi novel.

After their bioprinter fell victim to an October 2018 spacecraft crash, 3D Bioprinting Solutions rebounded; the team now collaborates with US and Israeli researchers at the ISS. Last month, their crew created the first space-bioprinted bone tissue. Similar to the US project, 3D Bioprinting Solutions aims to manufacture functioning human tissues and organs for transplantation and general repair.

Just because we have the technology to do it, should we do it?

If the 3D BioFabrication Facility prospers in printing working human organs, theyd be subject to thorough regulation here on Earth. The US approval process is stringent for any drug, Rich Boling says, posing a challenge for this unprecedented invention. Techshot predicts at least 10 years for space-printed organs to achieve legal approval, though its an inexact estimate.

Along with regulatory acceptance, human tissue printed in microgravity may encounter societal pushback.

Each country maintains varying laws related to medical transplants. Yet as bioengineering advances into the the final frontier, the international scientific research community may need to shape new guidelines for collaboration among the stars.

As the commercialization of low-Earth orbit continues to ramp up in the next few years, it is certainly true that were going to have to take a very close look at the regulations that apply to that, says International Space Station U.S. National Laboratory interim chief scientist Michael Roberts. And some of those regulations are going to stray into questions related to ethics: Just because we have the technology to do it, should we do it?

Niki Vermeulen, a University of Edinburgh science technology and innovation studies lecturer, has researched the social implications of 3D bioprinting experiments. Like any Earth-bound project, she urges scientists not to get peoples hopes up too early in the process; individuals seeking organ transplants could read about the BFF online and think it could soon be ready to meet their needs.

The most important thing now, I think, is expectation management, Vermeulen says. Because its really quite difficult to do this, and of course we really dont know if its going to work. If it did, it would be amazing.

Another main issue is cost. Like other cutting-edge biotechnology innovations, the organs could also pose a major affordability challenge, she says. Techshot claims that a single space-printed organ could actually cost less than one from a human donor, since some people must pay for a lifetime of anti-rejection meds and/or multiple transplants. Theres currently no telling how long the BFF process would actually take, however, compared to the conventional donor route.

Plus, theres potential health risks for recipients: Techshot chief scientist Eugene Boland says cell manipulation always presents a possibility of genetic mutation. Modified stem cells can potentially cause cancer in recipients, for example.

The team is now working to define and minimize any dangers, he says. The BFF experiment adheres to the FDAs specific regulations for human cells, tissues, and cellular and tissue-based products.

Researchers on the ground now hope to perfect human cell manipulation: Over 100 US clinical trials presently test cultured autologous human cells, and several hundred test cultured stem cells with multiple origins.

What comes next

After the next round of printing tests this March, Techshot will share the bioprinter with companies and research institutions looking to print materials like cartilage, bone, and liver tissue. Theyre currently preparing the bioprinter for these additional uses, Boling says, which could advance health care as a whole.

To speed things up for space crews, Techshot is now building a cell factory that produces multiple cell types in orbit. This technology could cut down the number of cell deliveries between Earth and space.

The ISS has taken in plenty of commercial ventures in recent years, Michael Roberts says, and its getting crowded up there. Space-based experiments ramped up between 40 and 50 years ago, though until recently they mostly prioritized satellite communications and remote observation technology. Since then, satellites have shrunk from bus-sized to smaller than a shoebox.

Roberts has witnessed the scientific areas of interest broaden over the past decade to include medicine. Organizations like the National Institutes of Health are now looking to space to improve treatments, and everything from large pharmaceutical companies to small-scale startups want in.

Theyve got something stuck on every surface up there, he says.

As the ISS runs out of space and exterior attachment points, Roberts predicts that commercial ventures will build new facilities built for specific activities like manufacturing and plant growth. He sees it as a good opportunity for further innovation, since the ISS was originally designed for far more general purposes.

Space, as a whole, may start to look quite different from the first exploration age.

Baby boomers may remember glimpsing at a grainy, black-and-white moon landing five decades ago. Within the same lifetime, they could potentially observe the introduction of space-printed organs.

See more here:
Space might be the perfect place to grow human organs - Popular Science

Biomedical researchers from Texas Tech University Health Sciences Center El Paso and the University of Texas at El Paso are working on a joint project to send miniature 3D bioprinted hearts to space. The research project, which has received backing from the National Science Foundation (NSF), seeks to understand how a microgravity environment affects the function of the human heart.

Bioprinting in space is a growing venture. The microgravity environment found aboard the International Space Station (ISS) provides a unique setting for bioprinted tissues and cellular structures to culture and grow. Bioprinting specialists like CELLINK and 3D Bioprinting Solutions are showcasing the potential of bioprinting in space, both for the advancement of bioprinting technologies and to understand the impact of zero-gravity on the human body.

The three-year research project conducted by the Texas-based research team falls into the latter category. The team, led by Munmun Chattopadhyay, Ph.D., TTUHSC El Paso faculty scientist, and Binata Joddar, Ph.D., UTEP biomedical engineer, wants to understand how the human heart is impacted by microgravity by testing bioprinted cardiac organoids aboard the ISS.

The cardiac organoids consist of heart-tissue structures measuring less than 1 mm in thickness which are bioprinted using human stem cells. The organoids will be sent to the ISS, where they will exposed to microgravity environments. This will provide vital insights into a condition commonly experienced by astronauts.

The condition in question is cardiac atrophy and it is caused by a weakening of heart tissue. The condition can lead to other problems, like fainting, irregular heartbeats and even heart failure. Because astronauts often suffer from cardiac atrophy after spending long stints in space, the researchers want to better understand the link.

Cardiac atrophy and a related condition, cardiac fibrosis, is a very big problem in our community, said Dr. Chattopadhyay. People suffering from diseases such as diabetes, muscular dystrophy and cancer, and conditions such as sepsis and congestive heart failure, often experience cardiac dysfunction and tissue damage.

The project, which officially started in September, is currently focused on research design. In this stage of the research, the team is developing bioprinted cardiac organoids and exploring different material compositions using cardiac cells to create heart-like tissue. The second stage of the research will be focused on preparing to launch to organoid to space. The final stage will consist of analyzing data collected during the organoids time in space, once they have returned to Earth.

Dr. Chattopadhyay expressed excitement about the ongoing research project, saying: Knowledge gathered from this study could be used to develop technologies and therapeutic strategies to better combat tissue atrophy experienced by astronauts, as well as open the doorforimproved treatmentsforpeople who suffer from serious heart issues due to illness.

The researchers also hope to engage the community with their research by offering a workshop for K-12 students about their experiments aboard the ISS. The team will also host a seminar for medical students, interns and residents about conducting research in space and on Earth.

Read more here:
El Paso researchers sending bioprinted mini hearts to ISS - 3DPMN

Vincent Smith

Without long-term outcome data, the risks of individual procedures cant be quantified, nor can the advantages of waiting versus intervening early. Its also unclear whether patients whove gone public reflect most intersex peoples experiences. Clinicians dont know how much of the reported distress arises from outdated surgical techniques, nor do they know yet whether current procedures will prove any better.

Researchers are attempting to better gauge outcomes and satisfaction rates. A forthcoming European report will describe the opinions of more than one thousand intersex patients and their doctors regarding satisfaction with anatomical and functional results of genital surgery, according to a 2019 review article in theJournal of Pediatric Urology. Institutions are conducting other retrospective and prospective studies, such as a U.S. endeavor at multiple sites, including HMS.

Clinicians also are turning to transgender patients for insight. Teens and adults can provide immediate feedback on medical and surgical procedures and describe broad ranges of desired outcomes, which can then inform intersex care, says surgeon Diamond. The relationship seems fitting, since certain surgical interventions for transgender affirmation were informed by procedures developed for infants with DSDs.

But for many intersex advocates, the wait is too long for the results of such endeavors. Over the past decade, advocacy groups have led a global movement calling for a moratorium on genital and gonadal surgeries without patient consent. International health and human rights organizations, including the United Nations and the World Health Organization, have condemned the procedures, and several countries have restricted them. In February, the European Parliament urged member states to prohibit nonconsensual sex-normalizing surgeries as soon as possible. Some medical societies, consortia, and prominent figures such as a trio of former U.S. surgeons general have echoed the call. Several states, such as California, have considered bans.

This sea change has evoked an array of reactions, even among patients. People with CAH in particular say that an outright ban will do more harm than good by depriving families of the option to choose surgery. Appending an objection to a 2019 consensus paper by German academics that supported a ban, one CAH group said the majority of those with CAH who identify as female are satisfied with the results of their feminizing surgery and glad to have completed it in infancy.

The idea that the bodily autonomy of intersex children supersedes parents traditional roles as health care proxies remains a point of contention. National medical ethics councils in Finland, Germany, Sweden, and Switzerland say parents cannot authorize medically unnecessary surgery on genitals or gonads; the 2016 Global DSD Update says they can. Though the United States has not ruled on DSDs, its law and culture generally side with parents right to choose, say Garland and Diamond, and many clinicians continue to defer to them on intersex care.

When we discuss the pros and cons of surgery with the family and they say, We understand the different ways to go and this is what we think is best for our child, I accept that that is a responsible way to manage the child, says Diamond.

Some clinicians fear losing the ability to use their medical expertise to guide families and make decisions based on individual cases. It is not logical to impose mandatory restrictions on surgery in an area as complicated as this, reads a 2017 joint statement from seven U.S. urology and endocrinology societies.

Rosario served as chair of the medical advisory board for the Intersex Society of North America from 2002 to 2006 before he joined the UCLA DSD clinic. Initially against infant genital-normalizing surgery, he found that my opinion softened with actual clinical experience, he says.

Arguments roil about where gender-normalizing surgery falls along the spectrum of acts performed on infant genitalia. All fifty U.S. states condemn female genital mutilation, some advocates point out, so why should intersex surgery be considered differently? Others make comparisons to male circumcision, yet that practice also has been questioned. Professional societies are increasingly supporting interventions for transgender patients, so why deny the choice to those with DSDs, people ask?

While individual clinicians may support restricting infant genital-normalizing surgery, Garland wonders whether the threat of malpractice litigation explains why the U.S. medical profession tends to emphasize following the standard of care rather than trying nonintervention. He adds that in countries where the law requires scientific evidence and careful testing to establish the safety and efficacy of medical interventions, its been determined that these surgeries clearly dont meet that standard.

Pressure to change may come from peers, such as the Massachusetts Medical Society, which is debating a recommendation to delay surgeries on infants with DSDs that are of a non-emergent status until the individual has the capacity to participate in the decision. Doctors listen to other doctors, points out Smith, who serves on the LGBTQ committee that submitted the proposal.

Lawsuits also could influence U.S. medical practice. In a case that settled out of court in 2017, parents sued two South Carolina hospitals and a social services department for having performed feminizing surgery on a child they later adopted who grew up to identify as male.

Should DSD care shift, we will need a new way of thinking about how to determine when a child is able to consent, says Garland.

Those who worry about the lack of comparative data between early, delayed, and no intervention may take note as more nations and institutions restrict surgery on minors.

We may have our control group developing in Europe, says Diamond.

As more practitioners view forgoing surgery as an option, they turn to more flexible alternatives meant to support patients gender expression, such as hormone treatments. Surgeons also consider middle-ground procedures that preserve gender options as children grow.

In a 2018 case review in theJournal of Pediatric Urology, Diamond and colleagues described three infants with genetic mosaicism and complex urogenital and gonadal features whose parents all opted, among other procedures, to create vaginas but preserve the phalluses while they waited for their children to develop a gender. Two families were tentatively raising their children female; the other, gender neutral.

I wouldnt have thought that way at all ten years ago, says Diamond, who estimates he sees one hundred DSD patients a year in the Behavioral Health, Endocrinology, Urology (BE-U) program at Boston Childrens. My frame of mind would have been that the surgical options were more of a binary choice.

To those who believe that refraining from intervention does the least harm, Diamond says, You do your best, and you do it with a lot of humility because you know that no matter what you do, as much data as you have, you may be wrong.

Clinicians continue to learn how to avoid inadvertently making things worse for people with DSDs. Research studies and patient advocacy reports have documented the long-term psychological harm stemming from health care experiences such as repeated genital examinations and photography, depersonalization, and demeaning language.

Thats part of why psychologists and social workers have become essential members of DSD care teams over the past 20 years, although experts agree that psychosocial care still isnt available to enough families.

Surgeons and other specialists focus on their areas, particularly on the genitals, and they dont pay as much attention to the rest of the person, says Rosario. My job is to ask, how are you doing in school, and how are you doing with friends?

Although there is variation across conditions, initial research suggests that people with DSDs are more prone than the general population to mental health problems, including depression, anxiety, suicidal ideation, post-traumatic stress disorder, and trouble with intimacy. Such disparities may arise from treatment, culture, or the biology of the DSDs themselves.

Other studies assess the frequency, severity, and nature of parental distress when children receive DSD diagnoses. Researchers at HMS and elsewhere have found that unexpected anatomical variations, the possibility of stigma, and lack of clarity about the childs cancer risk, fertility, and future gender identity can cause significant anguish. Yet they also have found that caregivers of intersex children are no more depressed and, in fact, are less anxious than the general population.

Still more questions center on what should be done if the bulk of distress over DSDs arises from societal rather than medical issues.

In an era of gender-reveal parties and bathroom access controversies, having a perfectly happy baby with DSD can be like a crisis for families, says Smith. If there are no accompanying medical issues, then it becomes an entirely social-driven crisis.

Clinicians and parents often cite the desire to protect children from social harm when they opt for gender-normalizing procedures. Why, critics ask, in a culture built around binary sex, is the standard solution to alter bodies that are nonbinary rather than broaden societal conceptions of sex and gender?

Its really fraught when a concerned parent or physician thinks that a child who is intersex, and maybe doesnt present in a typical manner, is therefore going to have a harder time in the world, says Potter. That might be true, it might not be true, but in any event, trying to fix it so that they look like people with binary bodies may make a big mess of things.

Maybe we should be trying to help parents, and by extension the people surrounding the parentsthe extended family, the school system, all of these placesbecome more knowledgeable that theres a spectrum of sex presentation, she adds. Instead of conforming a child to something, transform the world in which they live. Then life may not be so hard.

Thats where law can also play a significant role, stopping discrimination and encouraging increased support for parents and children, says Garland.

While Garland, Potter, and others envision a more DSD-friendly future, they acknowledge that the systemic changes required will take time and effort. Meanwhile, others point out, clinicians, patients, and families must live in todays cultural contexts.

Discomfort with atypical sex characteristics is very much a societal problem, but we are caring for human beings who are brought up in our society to think in certain ways, says Diamond. As physicians and as a society, weve evolved a great deal, but were not at the point, I think, where we can routinely be comfortable with ambiguity. Some families can take that leap, but they are so uncommon.

As our culture progresses, that balance may shift. The sharing of peoples preferred pronouns, encompassing a spectrum of identities beyond he/his and she/hers, is becoming more common. People with transgender, gender nonconforming, nonbinary, and intersex identities are increasingly out and proud.

Ive been very surprised and pleased to see how much has changed in the LGBT arena in the past twenty years, says Garland. Its dramatic worldwide. Acceptance has increased of people with different sexualities and genders.

If trends continue, then in another generation or two, the agitation around DSDs may calm. Doctors may deliver healthy intersex babies and simply say: Congratulations.

Stephanie Dutchen is a science writer in the HMS Office of Communications and External Relations.

Image: Cici Arness-Wamuzky (top); John Soares (Smith and Diamond); John Davis (Rosario)

(Reprinted with permission from the Harvard Gazette.)

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Don't Judge, Wait, and Know the Science: InterSex,The Body and The Self - India New England

The 2019 novel coronavirus (2019-nCoV) outbreak has sparked a speedy response, with scientists, physicians, and front-line healthcare professionals analyzing data in real-time in order to share findings and call out misinformation. Today, The Lancet published two new peer-reviewed studies: one which found that the new coronavirus is genetically distinct from human SARS and MERS, related viruses which caused their own outbreaks, and a second which reports clinical observations of 99 individuals with 2019-nCoV.

The first cases of the coronavirus outbreak were reported in late December 2019. In this new study, Nanshan Chen and colleagues analyzed available clinical, demographic, and laboratory data for 99 confirmed coronavirus cases at the Wuhan Jinyintan Hospital between Jan 1 to Jan 20, 2020, with clinical outcomes followed until 25th January.

Chen and colleagues reported that the average age of the 99 individuals with 2019-nCoV is around 55.5 years, where 51 have additional chronic conditions, including cardiovascular and cerebrovascular (blood flow to the brain) diseases. Clinical features of the 2019-nCoV include a fever, cough, shortness of breath, headaches, and a sore throat. 17 individuals went on to develop acute respiratory distress syndrome, resulting in death by multiple organ failure in 11 individuals. However, it is important to note here that most of the 2019-nCoV cases were treated with antivirals (75 individuals), antibiotics (70) and oxygen therapy (75), with promising prognoses, where 31 individuals were discharged as of 25th January.

Based on this sample, the study suggests that the 2019 coronavirus is more likely to affect older men already living with chronic conditions but as this study only includes 99 individuals with confirmed cases, it may not present a complete picture of the outbreak. As of right now, there are over 6,000 confirmed coronavirus cases reported, where a total of 126 individuals have recovered, and 133 have died.

In a second Lancet study, Roujian Lu and their fellow colleagues carried out DNA sequencing on samples, obtained from either a throat swab or bronchoalveolar lavage fluids, from eight individuals who had visited the Huanan seafood market in Wuhan, China, and one individual who stayed in a hotel near the market. Upon sequencing the coronaviruss genome, the researchers carried out phylogenetic analysis to narrow down the viruss likely evolutionary origin, and homology modelling to explore the virus receptor-binding properties.

Lu and their fellow colleagues found that the 2019-nCoV genome sequences obtained from the nine patients were very similar (>99.98% similarity). Upon comparing the genome to other coronaviruses (like SARS), the researchers found that the 2019-nCoV is more closely related (~87% similarity) to two bat-derived SARS-like coronaviruses, but does not have as high genetic similarity to known human-infecting coronaviruses, including the SARS-CoV (~79%) orMiddle Eastern Respiratory Syndrome (MERS) CoV (~50%).

The study also found that the 2019-nCoV has a similar receptor-binding structure like that of SARS-CoV, though there are small differences in certain areas. This suggests that like the SARS-CoV, the 2019-nCoV may use the same receptor (called ACE2) to enter cells, though confirmation is still needed.

Finally, phylogenetic analysis found that the 2019-nCoV belongs to the Betacoronavirus family the same category that bat-derived coronaviruses fall into suggesting that bats may indeed be the 2019-nCoV reservoir. However, the researchers note that most bat species are hibernating in late December, and that no bats were being sold at the Huanan seafood market, suggesting that while bats may be the initial host, there may have been a secondary animal species which transmitted the 2019-nCoV between bats and humans.

Its clear that we can expect new findings from the research community in the coming days as scientists attempt to narrow down the source of the 2019-nCoV.

Read this article:
Swamp sparrows can guess each other's ages from the sounds of their song - Massive Science

The 2019 novel coronavirus (2019-nCoV) outbreak has sparked a speedy response, with scientists, physicians, and front-line healthcare professionals analyzing data in real-time in order to share findings and call out misinformation. Today, The Lancet published two new peer-reviewed studies: one which found that the new coronavirus is genetically distinct from human SARS and MERS, related viruses which caused their own outbreaks, and a second which reports clinical observations of 99 individuals with 2019-nCoV.

The first cases of the coronavirus outbreak were reported in late December 2019. In this new study, Nanshan Chen and colleagues analyzed available clinical, demographic, and laboratory data for 99 confirmed coronavirus cases at the Wuhan Jinyintan Hospital between Jan 1 to Jan 20, 2020, with clinical outcomes followed until 25th January.

Chen and colleagues reported that the average age of the 99 individuals with 2019-nCoV is around 55.5 years, where 51 have additional chronic conditions, including cardiovascular and cerebrovascular (blood flow to the brain) diseases. Clinical features of the 2019-nCoV include a fever, cough, shortness of breath, headaches, and a sore throat. 17 individuals went on to develop acute respiratory distress syndrome, resulting in death by multiple organ failure in 11 individuals. However, it is important to note here that most of the 2019-nCoV cases were treated with antivirals (75 individuals), antibiotics (70) and oxygen therapy (75), with promising prognoses, where 31 individuals were discharged as of 25th January.

Based on this sample, the study suggests that the 2019 coronavirus is more likely to affect older men already living with chronic conditions but as this study only includes 99 individuals with confirmed cases, it may not present a complete picture of the outbreak. As of right now, there are over 6,000 confirmed coronavirus cases reported, where a total of 126 individuals have recovered, and 133 have died.

In a second Lancet study, Roujian Lu and their fellow colleagues carried out DNA sequencing on samples, obtained from either a throat swab or bronchoalveolar lavage fluids, from eight individuals who had visited the Huanan seafood market in Wuhan, China, and one individual who stayed in a hotel near the market. Upon sequencing the coronaviruss genome, the researchers carried out phylogenetic analysis to narrow down the viruss likely evolutionary origin, and homology modelling to explore the virus receptor-binding properties.

Lu and their fellow colleagues found that the 2019-nCoV genome sequences obtained from the nine patients were very similar (>99.98% similarity). Upon comparing the genome to other coronaviruses (like SARS), the researchers found that the 2019-nCoV is more closely related (~87% similarity) to two bat-derived SARS-like coronaviruses, but does not have as high genetic similarity to known human-infecting coronaviruses, including the SARS-CoV (~79%) orMiddle Eastern Respiratory Syndrome (MERS) CoV (~50%).

The study also found that the 2019-nCoV has a similar receptor-binding structure like that of SARS-CoV, though there are small differences in certain areas. This suggests that like the SARS-CoV, the 2019-nCoV may use the same receptor (called ACE2) to enter cells, though confirmation is still needed.

Finally, phylogenetic analysis found that the 2019-nCoV belongs to the Betacoronavirus family the same category that bat-derived coronaviruses fall into suggesting that bats may indeed be the 2019-nCoV reservoir. However, the researchers note that most bat species are hibernating in late December, and that no bats were being sold at the Huanan seafood market, suggesting that while bats may be the initial host, there may have been a secondary animal species which transmitted the 2019-nCoV between bats and humans.

Its clear that we can expect new findings from the research community in the coming days as scientists attempt to narrow down the source of the 2019-nCoV.

Read more here:
On Holocaust Remembrance Day, the stories of two Jewish scientists - Massive Science

Cryonics Technology Market research report 2019 gives detailed information of major players like manufacturers, suppliers, distributors, traders, customers, investors and etc. Cryonics Technology market Report presents a professional and deep analysis on the present state of Cryonics Technology Market that Includes major types, major applications, Data type include capacity, production, market share, price, revenue, cost, gross, gross margin, growth rate, consumption, import, export and etc. Industry chain, manufacturing process, cost structure, marketing channel are also analyzed in this report.The growth trajectory of the Global Cryonics Technology Market over the assessment period is shaped by several prevalent and emerging regional and global trends, a granular assessment of which is offered in the report. The study on analyzing the global Cryonics Technology Market dynamics takes a critical look at the business regulatory framework, technological advances in associated industries, and the strategic avenues.

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Prominent Manufacturers in Cryonics Technology Market includes PraxairCellulisCryologicsCryothermKrioRusVWRThermo Fisher ScientificCustom Biogenic SystemsOregon CryonicsAlcor Life Extension FoundationOsiris CryonicsSigma-AldrichSouthern Cryoni

Market Segment by Product Types Slow freezingVitrificationUltra-rapid

Market Segment by Applications/End Users Animal husbandryFishery scienceMedical sciencePreservation of microbiology cultureConserving plant biodiversity

In order to identify growth opportunities in the market, the report has been segmented into regions that are growing faster than the overall market. These regions have been potholed against the areas that have been showing a slower growth rate than the market over the global. Each geographic segment of the Cryonics Technology market has been independently surveyed along with pricing, distribution and demand data for geographic market notably: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Colombia etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa).

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Additionally, the complete value chain and downstream and upstream essentials are scrutinized in this report. Essential trends like globalization, growth progress boost fragmentation regulation & ecological concerns. Factors in relation to products like the products prototype, manufacturing method, and R&D development stage are well-explained in the global Cryonics Technology market research report with point-to-point structure and with flowcharts. It offers a comparative study between conventional and emerging technologies and the importance of technical developments in this market. At last, the market landscape and its growth prospects over the coming years have been added in the research.

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The Questions Answered by Cryonics Technology Market Report: What are the Key Manufacturers, raw material suppliers, equipment suppliers, end users, traders and distributors in Cryonics Technology Market? What are Growth factors influencing Cryonics Technology Market Growth? What are production processes, major issues, and solutions to mitigate the development risk? What is the Contribution from Regional Manufacturers? What are the Cryonics Technology Market opportunities and threats faced by the vendors in the global Cryonics Technology Industry? What are the Key Market segments, market potential, influential trends, and the challenges that the market is facing?And Many More

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Cryonics Technology Market Growth Rate, Demands, Status And Application Forecast To 2025 - Expedition 99

NEW YORK, Jan. 30, 2020 /PRNewswire/ --

High incidence of cancer & other target diseases is a major factor driving the growth of the gene therapy market

Read the full report: https://www.reportlinker.com/p05843076/?utm_source=PRN

The global gene therapy market is projected to reach USD 13.0 billion by 2024 from USD 3.8 billion in 2019, at a CAGR of 27.8% during the forecast period. The high incidence of cancer and other target diseases, availability of reimbursement, and the launch of new products are the major factors driving the growth of this market. In addition, the strong product pipeline of market players is expected to offer significant growth opportunities in the coming years. However, the high cost of treatment is expected to hamper market growth to a certain extent in the coming years.

Neurological diseases segment accounted for the largest share of the gene therapy market, by indication, in 2018Based on indication, the market is segmented into neurological diseases, cancer, hepatological diseases, Duchenne muscular dystrophy, and other indications.The neurological diseases segment accounted for the largest share of the market in 2018.

This can be attributed to the increasing number of gene therapy products being approved for the treatment of neurological diseases and the high market penetration of oligonucleotide-based gene therapies.

Viral vectors segment to register the highest growth in the gene therapy market during the forecast periodThe gene therapy market, by vector, has been segmented into viral and non-viral vectors.In 2018, the non-viral vectors segment accounted for the largest share of this market.

However, the viral vectors segment is estimated to grow at the highest CAGR during the forecast period, primarily due to the increasing demand for CAR T-based gene therapies and the rising incidence of cancer.

North America will continue to dominate the gene therapy market during the forecast periodGeographically, the market is segmented into North America, Europe, the Asia Pacific, and the Rest of the World.In 2018, North America accounted for the largest share of the gene therapy market, followed by Europe.

Factors such as the rising prevalence of chronic diseases, high healthcare expenditure, presence of advanced healthcare infrastructure, favorable reimbursement scenario, and the presence of major market players in the region are driving market growth in North America.

The primary interviews conducted for this report can be categorized as follows: By Company Type: Tier 1 - 32%, Tier 2 - 44%, and Tier 3 - 24% By Designation: C-level - 30%, D-level - 34%, and Others - 36% By Region: North America - 50%, Europe - 32%, Asia Pacific - 10%, and Rest of the World - 8%

List of companies profiled in the report Amgen, Inc. (US) Biogen (US) Novartis AG (Switzerland) Gilead Sciences, Inc. (US) Spark Therapeutics, Inc. (US) MolMed S.p.A. (Italy) Orchard Therapeutics plc. (UK) SiBiono GeneTech Co., Ltd. (China) Alnylam Pharmaceuticals, Inc. (US) Human Stem Cells Institute (Russia) AnGes, Inc. (Japan) Dynavax Technologies (US) Jazz Pharmaceuticals, Inc. (Ireland) Akcea Therapeutics (US) bluebird bio, Inc. (US) uniQure NV (Netherlands) AGTC (US) Mustang Bio (US) Cellectis (France) Poseida Therapeutics, Inc. (US) Sangamo Therapeutics (US)

Research Coverage:This report provides a detailed picture of the global gene therapy market.It aims at estimating the size and future growth potential of the market across different segments (by vector, indication, delivery method, and region).

The report also includes an in-depth competitive analysis of the key market players, along with their company profiles, recent developments, and key market strategies.

Key Benefits of Buying the Report:This report will help market leaders/new entrants by providing them with the closest approximations of the revenue numbers for the overall gene therapy market and its subsegments.It will also help stakeholders better understand the competitive landscape and gain more insights to position their business better and make suitable go-to-market strategies.

Also, this report will enable stakeholders to understand the pulse of the market and provide them with information on the key market drivers, challenges, and opportunities.

Read the full report: https://www.reportlinker.com/p05843076/?utm_source=PRN

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The global gene therapy market is projected to reach USD 13.0 billion by 2024 from USD 3.8 billion in 2019, at a CAGR of 27.8% - PRNewswire

Taken together, cell and gene therapy could be called Philadelphias signature industry, and soon it may have its signature project.

Courtesy of The Discovery Labs

A rendering of the Center for Breakthrough Medicines, a cell and gene therapy manufacturing facility at The Discovery Labs in King of Prussia, Pa.

On Jan. 23, The Discovery Labs announced it will soon build a $1.1B, 680K SF contract development and manufacturing facility within its 1.6M SF campus in King of Prussia, as part of a joint venture with New York-based Deerfield Management. This Center for Breakthrough Medicines would take up the majority of the 1M SF former GlaxoSmithKline lab and manufacturing complex at 411 Swedeland Road that is part of Discovery Labs.

It will employ 2,000 people and become easily the largest contract development and manufacturing organizationin the world.

Though industry consensus isthat cell and gene therapy needs more manufacturing capability to keep growing and to speed up crucial development timelines, multiple sources told Bisnow that the Discovery Labs plan for CBM might be too ambitious in scale, price and timeline.

An unprecedented price tag for investors

Currently, the title for the largest cell and gene therapy manufacturing facility is held by Lonza, whichopened a 300K SF building in the Houston suburb of Pearland, Texas, in 2018. Lonza says itemploys over 200 full-time staffers at the facility. In the Philadelphia region, the only CDMO of any size is Wuxi AppTecs 287K SFcomplexat the Philadelphia Navy Yard. The new facility in King of Prussia has much larger ambitions.

[CBM] would service the world, Discovery Labs Executive Managing Director Audrey Greenberg said. Whats great about the King of Prussia location and the region, not just from the perspective of talent, is were very close to Europe on the East Coast. So well be able to supply viral vectors and plasmids to much of the U.S., Europe and possibly even Asia Pacific, South America and the Middle East.

Discovery Labs co-founder Brian ONeill, who also owns development firm MLP Ventures, is putting up initial funding for CBM, with some help from Deerfield and additional investors to join in later, Greenberg said. If ONeill needs to raise even half of the $1.1B price tag from outside investors, he may have a hard time finding anybody willing to put up the requisite cash for an operation that wont be developing its own intellectual property, sources said.

Both Greenberg and Jim Daly, a project director for biotech architecture and design firm CRB specializing in cell and gene therapy, believe that the pool of potential investors for the fledgling industry is deep and actively searching for deals.

I am amazed at the amount of capital that is behind so many companies, some of which didnt exist a year ago, Daly said. [But] thats a pretty rich number to try to get folks to step up for.

Courtesy of DIGSAU

A rendering of Iovance Biotherapeutics' lab, office and cell therapy manufacturing facility at the Philadelphia Navy Yard.

Raising funds is the hardest part about bringing a manufacturing facility online, whether a CDMO or a companys own build-to-suit,Gattuso Development Partners President John Gattuso said. Gattuso is developing a136K SF build-to-suit lab and manufacturing facility in the Navy Yard for Iovance Biotherapeutics. Until that is ready, Iovance contracts its production to Wuxi.

Amicus Therapeutics, which recently took space at uCity Square in University City, contracts with Wuxi, Daly said. Spark Therapeutics, the darling of Philadelphias gene therapy scene for getting multiple therapies FDA-approved, contracts out its manufacturing as well.

The University of Pennsylvania and Childrens Hospital of Philadelphia, the academic birthplace of Phillys gene and cell therapy startups, both have their own production needs met on campus, Daly said.

Before a company's therapy gets Food and Drug Administration approval, it relies on venture capital investment and grants to fund its research and development. Having a facility that can service many of them fills a gap in the market, Gattuso said, but a 680K SF facility may be considered too large todepend on non-revenue producers.

If you just think about how to finance a large facility filled with nothing but early, noncredit companies, its hard to imagine," Gattuso said.

Meeting the specific needs of a new, niche industry

Gene and cell therapy have material needs that require specialized manufacturing at every stage, from early research to commercial production for patients. Currently, no single contract facility has the manufacturing capability to meet those needs from bench to bedside, Greenberg said.

To research and develop new gene therapies, labs need plasmids (simple, circular strands of DNA) and viral vectors (benign containers for introducing new genes in a body) for every stage. Once a therapy is developed and can be used in clinical trials and eventually distributed to patients, then a company needs to effectively reproduce the finished product. All of these processes need to be done in highly sterilized clean room environments that are more complex and expensive than even most lab environments.

At full build-out, CBM is set to contain 36 suites for cell therapy processing, 10 for the production of plasmids, 20 for the production of viral vectors, and 20 for testing, process development and cell banking (or the storage of live cells needed for future batches). The suites will have a modular design so they can adapt to a changing client base and future advancements in production.

Courtesy of The Discovery Labs

A partial rendering of The Discovery Labs, MLP Ventures' planned biotech and life sciences coworking community in the Philadelphia suburb of King of Prussia.

Cell and gene therapy are both at such an early stageuntil some of those advancements come to pass, it is prohibitively expensive for a company to scale up to the point where it can fill and afford its own dedicated facility. Gene therapy can be produced in batches that can be only so large before the cell lines break down, and cell therapy is still dependent on autologous treatment, which means that each iteration only can serve one patient.

Those challenges and costs associated with project size are exactly what CBM is hoping to address, but multiple sources agreed that if a company has the resources, it will virtually always prefer to have its own facility to better control both the manufacturing process and its intellectual property.

Once you get to a certain scale, we see a strong desire on the part of certain firms to really control their own environment and be in their own building, Gattuso said. Its not just having the facility available, its about who controls that facility and how the IP is handled inside the facility.

Greenberg estimates there is five times more demand than supply for manufacturing in the gene and cell therapy industries nationwide, and that in three years that could explode to 5,000 times more demand than supply. Multiple sources in the industry agree that there is a substantial bottleneck in procuring the plasmids and viral vectors needed for even the early phases of research, but beyond that it is an unsettled issue.

The uncertain next steps

Though more than 200 "investigational new drug" permits have been issued in the past couple of years by the FDA, those only fast-track the clinical testing of methods for treating diseases and conditions so rare that few, if any, alternatives exist for sufferers.

Since two gene therapies and one cell therapy were fully approved by the FDA in 2017, only three more have gained approval since, Dark Horse Consulting founder Anthony Davies said at the Phacilitate conference in Miami on Jan. 22,according to BioProcess International. The first approved cell therapy, made by Novartis, has been halted by the FDA for manufacturing issues for over a year, Davies said.

Courtesy of The Discovery Labs

An interior rendering of gene and cell therapy hub The Discovery Labs in King of Prussia, Pa.

That frustration doesn't dampen CBM's prospects, as even therapies that will eventually fail need manufacturing capability. But if startups stuck in limbo between their earliest phases and full commercialization are in CBM's sweet spot, then a breakthrough that opens the floodgates could lead to those same companies instead opting for their own space, Daly said.

Part of the reason were seeing the bottleneck is in the supply side, and that would suggest that this is only a temporary phenomenon," Daly said. "As the Iovances of the world start to build out and manufacture their own plasmids and vectors, that demand will wane. That sides not super complicated or difficult; its more about what theyre prioritizing now.

Discovery Labs is in the design phase for CBM as of the end of January, but expects to begin gutting and renovating the former GSK facility within the next three months and bringing its first suites online by the end of this year. Greenberg estimates the first phase to open will amount to 50K to 75K SF of clean room space and about 100K SF for testing and development, which will require about 175 to 200 employees to staff.

Even working with a pre-existing facility that has many of the specialized needs for gene and cell therapy manufacturing, CBM's timeline of less than a year stretches credibility, multiple sources toldBisnow.Meeting the high standards for sterilization and IP protection is an exacting process that requires construction labor more specialized than for the average office building, though Gattuso said Philadelphia is maybe the best market in the country for finding that specific labor.

Staffing the building once operational will be an even taller task; sources estimate that training and getting clean room certification for technicians could take months on its own. The Discovery Labs hopes to address that by opening up its own training school, the Science University of Experiential Learning, within its grounds, but that won't be ready for that first wave of employees CBM will need by year's end.

Because of how much success Penn and CHOP have had in producing talent for gene and cell therapy production, the Philadelphia region makes sense as a place to try building something unprecedented. But despite the area's pride and optimism in its burgeoning industry's growth potential, CBM may be too much, too soon.

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The Biggest Gene And Cell Therapy Manufacturer Is Getting Built In King Of Prussia. Is It Too Ambitious? - Bisnow

A novel base editing technology invented at Rutgers, The State University of New Jersey with the potential to be used for the creation of new cell and gene therapies will be made available to researchers worldwide through an exclusive partnership with the Horizon Discovery Group.

The technology invented by Shengkan Victor Jin, associate professor of pharmacology, and co-inventor Juan C. Collantes, post-doctoral research fellow, at Rutgers Robert Wood Johnson Medical School can be potentially used for developing cell therapies for sickle cell anemia and beta thalassemia, HIV resistant cells for AIDS, off-the-shelf CAR-T cells for cancer, and MHC-compatible allogenic stem cells for transplantation. It could also be used as gene therapies for inherited genetic diseases such as antitrypsin deficiency and Duchenne muscular dystrophy.

The gene editing technology developed by our researchers has the potential to revolutionize how scientists think about their search for better options and outcomes in the treatment of disease worldwide, said S. David Kimball, PhD, Senior Vice President for Research and Economic Development at Rutgers University. Just as important is our ability, through this significant partnership with Horizon Discovery Group, to share our discoveries and inventions with the scientific community around the world who are equally committed to improving human health.

In January 2019, Rutgers University formed an exclusive partnership with Horizon to further the development of the proprietary base editing technology invented by Jin and Collantes. Since the initial partnership, Horizon, a global leader in the application of gene editing and gene modulation technologies, has been funding research in base editing at Jins laboratory. The company has now exercised its option to exclusively license the technology for commercialization of all therapeutic applications. This partnership places Rutgers among the front runners in the field of gene editing.

The technology could have a significant impact in enabling cell therapies to be progressed through clinical trials and towards commercialization. Horizon is pleased to offer an effective and precise base editing technology and, alongside Rutgers, aims to make base editing available to all appropriate cell and gene therapy companies as well as research departments. Partnering with leading organizations will help us to drive innovation and deliver the best therapy for the patient, stated Dr. Jonathan Frampton, Corporate Development Partner, Horizon Discovery.

Horizon has a number of internal programs designed to accelerate the clinical uptake of this technology and is now seeking partners to assess and shape the development of its Pin-point base editing platform. The company will offer partners access to a novel system that could be used to advance more effective multi-gene knockout cell therapy programs, with an improved safety profile, through clinical development. Partners will also gain access to the companys expertise in genome engineering of different cell types, access to early technical data, and influence over the direction of future development.

We intend to take full advantage of the unique modular and versatile features of the Pin-point platform and develop efficient gene inactivation agents for potential treatment of many devastating diseases where the leading causal contributing factors are well-defined. At the top of this disease list are Alzheimers disease, amyotrophic lateral sclerosis, and familial hypercholesterinemia, said Jin.

Base editing is a novel technology for engineering DNA in cells, with the potential to correct certain errors or mutations in the DNA or inactivate disease-causing genes. Compared with currently available gene editing methodologies such as conventional CRISPR/Cas9, which creates cuts in the gene that can lead to adverse or negative effects, this new technology allows for accurate gene editing while reducing unintended genomic changes that could lead to deleterious effects in patients.

# # #

About Rutgers, The State University of New Jersey

Rutgers, The State University of New Jersey, is a leading national research university and the state of New Jerseys preeminent, comprehensive public institution of higher education. Established in 1766, the university is the eighth oldest higher education institution in the United States. More than 70,000 students and 23,400 full- and part-time faculty and staff learn, work, and serve the public at Rutgers locations across New Jersey and around the world.www.rutgers.edu

As the premier public research university in the state, Rutgers is dedicated to teaching that meets the highest standards of excellence, to conducting cutting-edge research that breaks new ground and aids the states economy, businesses, and industries, and to providing services, solutions, and clinical care that help individuals and the local, national, and global communities where they live.research.rutgers.edu

Originally posted here:
Rutgers partners with Horizon Discovery Group | - University Business

Pfizer aims to be the third big pharma with a significant presence in gene therapy. Its plans to initiate this year three Phase 3 trials targeting mutation-driven blood and muscular diseases would make it a large player in this cutting-edge area of medicine.

The difference between Pfizer and its Swiss rivals Novartis and Roche is that its treatments for muscular dystrophy and hemophilia do not look like they will be the first to market. With hopes that gene therapy could be a one-and-done treatment, arriving second could put Pfizer at a disadvantage if eager patients rush for curative therapies.

Having spun of its off-patent drugs business, the pharma is now trying to talk up the "new Pfizer." Its gene therapies are among seven pipeline projects that it cited Tuesday during its year-end earnings call as critical to its strategy of becoming a more innovation-focused company.

Company executives weren't, however, asked to answer how Pfizer views the emerging gene therapy competition. BioMarin Pharmaceutical looks set to get to the market earlier in hemophilia A than Pfizer, while Uniqure in hemophilia B and Sarepta Therapeutics in Duchenne muscular dystrophy appear ahead.

Pfizer's hemophilia A project, the Sangamo Therapeutics-originated SB-525, is up against BioMarin's valrox, which has been submitted to the Food and Drug Administration for an approval decision later this year.

In hemophilia B, fidanacogene elaparvovec, licensed from Roche subsidiary Spark Therapeutics, is in a neck-and-neck race with UniQure's etranacogene dezaparvovec in Phase 3 testing. Duchenne research, meanwhile, is led by Sarepta, which is launching a Phase 3 trial of its drug this year, putting Pfizer's at a disadvantage.

Other than announcing its intent to launch Phase 3 trials in hemophilia A and Duchenne, Pfizer didn't provide much more detail about these clinical programs. Mikael Dolsten, Pfizer's chief scientific officer, said more could be revealed about the DMD program at an upcoming research & development day.

Progress on that project had been delayed after one patient was hospitalized with kidney complications, but Dolsten said trial investigators had dosed additional patients. The Phase 2 will wrap up this spring, and the new data and longer follow-up will help guide a Phase 3 trial design, the company said.

Dolsten also described the hemophilia A project as having a 'best-in-class profile," even though BioMarin's valrox has impressed hematologists with its ability to increase expression of a key blood-clotting protein.

In addition, he said the company hopes it can bring one new gene therapy into its pipeline per year.

Building its drug development portfolio is one reason why the company has chosen not to buy back shares, said CEO Albert Bourla.

He pointed to the company's need in the past to buy back shares to support their valuation because of revenue declines, but now he said the company is in a different strategic position.

"The company is going to have a best-in-class revenue growth story," he said. "We can use the capital to invest in good Phase 2, Phase 3 assets to grow our pipeline."

Original post:
Pfizer lays out gene therapy aspirations - BioPharma Dive