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Coronavirus: Doctors try 3,000-year-old Traditional Chinese Medicine (TCM) to treat the virus – Times of India

February 20th, 2020 3:48 pm

The novel coronavirus has claimed around 1,770 lives and affected almost 70,000 people with no possible cure in sight. Scientists all over the world are working hard to find treatment. More than 80 clinical trials have been launched to find the treatment for the deadly virus. While trying everything from stem cell therapy to HIV drugs, China has resorted to giving a 3,000-year-old traditional remedy a trial, to treat the patients. The new health commission head in Hubei, Wang Hesheng said that their efforts have shown some good results and the Traditional Chinese Medicine experts have been sent to Hubei for research and treatment. The treatment in Wuhan hospital combines Traditional Chinese Medicine, commonly known as TCM and western medicines. This combination is given to more than half of the confirmed cases in Hubei.

The reports of treatments and vaccine of those infected with the virus have caused ripples of excitement in people who are looking at it as a sign of hope!

What is Traditional Chinese Medicine?Traditional Chinese Medicine ranges back to thousands of years. TCM practitioners use various mind and body practices (acupuncture, tai chi, Chinese herbal products) to address several health issues.

Coronavirus in IndiaTill now there have three positive cases of novel Coronavirus in Kerela, India. The good news is that out of these three, two patients have already been discharged after showing negative results for the test of the virus.

Common symptoms of novel coronavirusThe initial symptoms of novel coronavirus are very similar to that of normal cold and flu. Common symptoms include:

- Fever

- Cough

- Shortness of breath

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Coronavirus: Doctors try 3,000-year-old Traditional Chinese Medicine (TCM) to treat the virus - Times of India

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Vision Impact Institute and Optometry Giving Sight Extend Collaboration on Kids See: Success – Yahoo Finance

February 20th, 2020 3:47 pm

Three-year-old initiative advocates for eye exams for children before they start school

DALLAS, Feb. 20, 2020 /PRNewswire/ --The Vision Impact Institute (VII) and Optometry Giving Sight (OGS) have announced an extension of their collaboration, Kids See: Success, that includes a generous financial commitment from OGS. Launched in 2017, Kids See: Success promotes the importance of healthy vision for children and educates parents, legislators, advocacy groups, nurses, school teachers and administrators about the need for comprehensive eye exams for school-age children. The initiative is active in several US states. In the U.S., more than 12.1 million school-age children have some form of vision problem.

The partnership is a natural fit for both organizations. The VII raises awareness and advocates for the priority of good vision, while OGS supports programs globally that train eye care professionals, promote communityeducation, raise awareness of the importance of eye health, establish optometry schools and deliver eye care and glasses.

"The continued support of OGS ensures that more children will have access to a level playing field when it comes to their education," says Kristan Gross, VII's global executive director. "When children can't see well it impacts so many aspects of their lives, including their learning and chance for future success."

"It's heartening to know that we have a solution for poor vision for the youngest members of our population," says Eric Anderson, interim executive director at OGS. "A comprehensive eye exam and access to a pair of glasses is a simple way to have a big impact on a child's life for years to come. It's the reason we continue our commitment to Kids See: Success."

About the Vision Impact Institute The Vision Impact Institute's mission is to raise awareness ofthe importance of vision correction and protection to make good vision a global priority. Its Advisory Board is comprised of six independent international experts: Pr. Kevin Frick(United States), Pr. Clare Gilbert (United Kingdom), Mr. Allyala Nandakumar (United States),Mr. Arun Bharat Ram (India), Dr. Serge Resnikoff (Switzerland),and Dr. Wang Wei (China).

The Vision Impact Institute is a registered 501(c)(3) non-profit organization, which receives support from the Vision for Life Fund from Essilor, the world leader in ophthalmic optics. The Vision Impact Institute hosts a unique database of research atvisionimpactinstitute.org.

Contact:Andrea Kirsten-ColemanGlobal Communications Manager andrea.kirsten@visionimpactinstitute.org

View original content to download multimedia:http://www.prnewswire.com/news-releases/vision-impact-institute-and-optometry-giving-sight-extend-collaboration-on-kids-see-success-301008590.html

SOURCE Vision Impact Institute

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Vision Impact Institute and Optometry Giving Sight Extend Collaboration on Kids See: Success - Yahoo Finance

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Johnson & Johnson Vision Calls on Individuals Worldwide to Prioritize Your Eyes in 2020 – PharmaLive

February 20th, 2020 3:47 pm

Jacksonville, Fla. and Santa Ana, Calif., February 20, 2020 Johnson & Johnson Vision, a global leader in eye health, today announced the launch of Prioritize Your Eyes, a worldwide effort to raise awareness about the connection of eye health to overall health. Prioritize Your Eyes encourages everyone to take the single most important step to protect their eyesgetting an eye examand is part of the companys ongoing commitment and collaboration with various partners and professional organizations to elevate eye health and make 2020 the year of greater eye health awareness.

Click to Tweet: Sight is our most valued sense, but only 1 in 100 people understand the importance of eye exams. @JNJVision encourages you to #PrioritizeYourEyes by getting an eye exam in 2020and continues its efforts to provide those in need with access to eye care: bit.ly/323V9Uf

More than 2 billion people around the world suffer from visual impairment, yet 1 billion of these instances could have been prevented or is yet to be addressed.[i] Additionally, the number of people experiencing blindness and visual impairment globally is expected to double by 2030 unless corrective measures are taken.[ii]

The prevention and treatment of life-altering eye conditions can start with a single eye exam, which can detect more than 270 different medical conditions such as diabetes, heart disease and stroke risk, as well as cataracts, glaucoma, or retinal disorders such as macular degeneration.[iii] Despite the wide variety of health benefits that could result from an annual eye exam, only one in 100 people understand the importance of getting one.[iv]

In the U.S., about half of adults at high-risk for vision loss did not visit an eye care professional in the last 12 months2 and more than a third of children under 18 have never received an eye exam,[v] said Carol Alexander, OD, Head, North America Vision Care Professional Relations, Johnson & Johnson Vision. Many people wait to see their eye care professional until they experience blurry vision, which may be too late. Certain serious eye conditions, as well as general health conditions, do not have any symptoms and can be detected through a comprehensive eye exam. This is why an annual eye exam is so vital and why were working to help Prioritize Your Eyes.

Johnson & Johnson Vision is committed to working with the eye health community to change the trajectory of eye health worldwide. Examples of this ongoing commitment are highlighted within the just released Our Global Vision for Good: 2019 Community Impact Report, which details the companys signature charity partnerships and efforts to provide access to eye care to those in need:

As part of the worlds largest healthcare company, Johnson & Johnson Vision is working collectively to make 2020 the year of visionusing our size and reach to elevate eye health awareness and the importance of eye exams to help as many people as possible, said Shlomi Nachman, Company Group Chairman, Cardiovascular Specialty Solutions Group and Johnson & Johnson Vision. We are proud to have provided access to care to millions of people around the world and look forward to further increasing our collaborations with advocacy, professional, and charitable organizations to help make caring for your eyes a global health priority.

You can find an eye care professional for an annual eye exam here, and follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn to see how patients, eye care professionals, employees and partners worldwide make the commitment toPrioritize Your Eyes in 2020.

About Johnson & Johnson Vision At Johnson & Johnson Vision, part of Johnson & Johnson Medical Devices Companies*, we have a bold ambition: to change the trajectory of eye health around the world. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better and live better. Visit us at http://www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

Johnson & Johnson Medical Devices Companies As the worlds most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics, vision and interventional solutions, were working to profoundly change the way care is delivered. We are in this for life.

*Comprising the surgery, orthopaedics, vision and interventional businesses within the Johnson & Johnsons Medical Devices segment

Media Contact:

Abby Reiner

Johnson & Johnson Vision

904-443-1604

[emailprotected]

Source: Johnson & Johnson Vision

https://www.jjvision.com/press-release/johnson-johnson-vision-calls-individuals-worldwide-prioritize-your-eyes-2020

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Gene therapy to halt rare form of sight loss – BBC News

February 20th, 2020 3:47 pm

Image caption Matthew Wood hopes the gene therapy will help him keep his remaining vision

A new gene therapy has been used to treat patients with a rare inherited eye disorder which causes blindness.

It's hoped the NHS treatment will halt sight loss and even improve vision.

Matthew Wood, 48, one of the first patients to receive the injection, told the BBC: "I value the remaining sight I have so if I can hold on to that it would be a big thing for me."

The treatment costs around 600,000 but NHS England has agreed a discounted price with the manufacturer Novartis.

Luxturna (voretigene neparvovec), has been approved by The National Institute for Health and Care Excellence (NICE), which estimates that just under 90 people in England will be eligible for the treatment.

The gene therapy is for patients who have retinal dystrophy as a result of inheriting a faulty copy of the RPE65 gene from both parents. The gene is important for providing the pigment that light sensitive cells need to absorb light. Initially this affects night vision but eventually, as the cells die, it can lead to complete blindness.

An injection is made into the back of the eye - this delivers working copies of the RPE65 gene. These are contained inside a harmless virus, which enables them to penetrate the retinal cells. Once inside the nucleus, the gene provides the instructions to make the RPE65 protein, which is essential for healthy vision.

Matthew Wood started losing his sight as a child, and is now registered blind. However, he does have some peripheral vision and can detect large objects and bright lights. He told the BBC: "Since I was a child I was continually told there was no treatment for this condition, so it's amazing to receive this gene therapy."

Mr Wood, from London, had his right eye treated during an hour-long operation at the John Radcliffe Hospital in Oxford.

His left eye will be injected in a few weeks. The surgery was carried out by Prof Robert MacLaren, who has pioneered research into gene therapies for preventing blindness.

He told the BBC: "This is very exciting - this is the first approved NHS gene therapy for an eye disease, but there are opportunities to use gene therapy to treat other diseases in future, not only in the eye."

The treatment is only suitable for patients who have some remaining vision. It should bring the biggest benefits to children with RPE65 retinal dystrophy, as it could halt sight loss before permanent damage is done.

It is not known how long the benefits of the treatment will last, but it's thought it could be several decades.

Jake Ternent, 23, from Durham, had his gene therapy at Moorfields Eye Hospital in London.

Like Matthew Wood, he is registered blind, but has some limited sight. He told the BBC: "I hope the treatment could improve my night vision, and possibly even my day vision, which would be incredible. I feel lucky and privileged to get this on the NHS."

Prof James Bainbridge - from Moorfields Eye Hospital - who treated Jake, told the BBC: "To be at the point now where we are able to offer this treatment on the NHS, is truly remarkable. This is the first example of what's anticipated to be a whole new generation of treatments."

It will take a month or two before Matthew and Jake know what changes the gene therapy has made to their vision. But even if it simply prevents further sight loss, both say they will be delighted.

Professor Stephen Powis, NHS medical director, said: "Loss of vision can have a devastating effect, particularly for children and young people, but this truly life-changing treatment offers hope to people with this rare and distressing condition."

Follow Fergus on Twitter.

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Gene therapy to halt rare form of sight loss - BBC News

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Noticing a glow in her eye, Second Lady saves daughters sight – ABC27

February 20th, 2020 3:47 pm

In each photo of her three young children, Second Lady of Pennsylvania Gisele Fetterman noticed a pattern.

I saw a consistency, red eyes in both my boys, but in her I noticed one red eye and one yellow eye, Fetterman saod.

One of Grace Fettermans eyes had a yellow glow. At the time, Gisele didnt know what it meant, so she called a local doctor.

He said to pull her out of school immediately, she recalled. I learned in her case it was Coats Disease, but in many cases, its cancer or a tumor. She would have lost her eyesight completely in one eye.

Coats Disease is a rare eye disease caused by abnormal development of the blood vessels of the retina, said Dr. Erica Beaver, an optometrist with Premier Eye Care.

For 8-year-old Grace, wearing glasses corrected the issue. She no longer has to wear them but goes in every six months for check-ups. The Fettermans are sharing Graces story so other families know the glow.

According to the CDC, less than 15% of preschool kids get an eye exam but childhood exams are key to detecting eye issues.

Beaver says babies should have their first eye exam between six and 12 months old, when the eyes are starting to develop, so issues with the eye or diseases like Coats can be detected.

After the initial exam, as long as everything is healthy, the next eye exam should be scheduled between ages 3 and 5 then once every 1 to 2 years after.

If the child is complaining about vision or pain in the eye or headaches, get them checked, said Beaver. Parents can also look for squinting, closing one eye or tilting their head to see more clearly.

Eye screenings done at school or at the pediatricians office are not the same as an in-office eye exam, Beaver says. Those are vision screenings for distance or near vision, not a look at the health of the eye.

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Noticing a glow in her eye, Second Lady saves daughters sight - ABC27

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Prevent Blindness to Hold 15th Annual ‘Eyes on Capitol Hill’ Advocacy Event – InvisionMag

February 20th, 2020 3:47 pm

(PRESS RELEASE) SAN RAMON, CA CooperVision has become a global patron of the International Agency for the Prevention of Blindness. The company becomes part of a select group of leaders including Allergan, Bayer, Novartis and Standard Chartered Bank that supports IAPB at the highest level to help achieve universal access to eye health.

As part of the relationship, CooperVision and IAPB will collaborate to bring greater awareness and action to the growing prevalence and severity of myopia in children worldwide. A seminal 2015 report on the issue from the World Health Organization (WHO) declared that myopia and high myopia are increasing globally at an alarming rate, with significant increases in the risks for vision impairment from pathologic conditions associated with high myopia.

CooperVision has a heritage of addressing widespread refractive issues such as astigmatism and presbyopia. More recently, we have taken on even greater challenges such as childhood myopia, not only correcting it but also successfully slowing its progression, said Daniel G. McBride, president of CooperVision. Even with the remarkable progress were making, no single organization can do this alone. Were optimistic about what our new partnership with IAPB will mean for millions of children, adults and families worldwide.

IAPB are excited about the opportunity to partner with CooperVision to create sustainable and lasting change in eye health, including addressing the substantial global increase in myopia, said Peter Holland, chief executive, IAPB. The leadership, insight and innovation of our Patrons regularly unearth new approaches, models and alliances for greater collective and individual impact. By working together, we exponentially increase our abilities to confront and overcome vision impairment issues.

In addition to its IAPB patronage, CooperVision contributes significant funding, knowledge and time to a range of eye health-focused organizations every year. These include being a founding member of the Global Myopia Awareness Coalition, a Global Platinum sponsor of Optometry Giving Sight, and partner in Our Childrens Vision. As part of its corporate responsibility initiatives, CooperCompanies is also aligned with the United Nations Sustainable Development Goals, concentrating on good health and well-being, responsible consumption and production and complementary partnerships.

CooperVision develops a range of products designed to aid eye care professionals. Silicone hydrogel soft contact lens brands such as Biofinity and clariti 1 day are worn by millions worldwide. Its myopia care portfolio includes advanced lenses such as Paragon CRT and Procornea DreamLite designed for overnight wear (orthokeratology), as well as innovations such as MiSight 1 day contact lenses for slowing the progression of myopia in children (8-12 years of age at the initiation of treatment).

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Prevent Blindness to Hold 15th Annual 'Eyes on Capitol Hill' Advocacy Event - InvisionMag

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Newly discovered: The USA organic solution that cures cataract, glaucoma, blurry vision, other eye problem … – Daily Post Nigeria

February 20th, 2020 3:47 pm

If youre tired of struggling with poor eyesight, specifically someone who wants to improve their vision, reverse glaucoma, cataract, near-sightedness and wants to stop using glasses, then here is good news.

There is a newly discovered USA Organic remedy that has helped over 642 Nigerian men, women and children restore eyesight, improve vision and cure severe eye problems within few weeks.

You see

As it says above, I was a glaucoma and cataract sufferer, and for several years I was battling with this eye condition. I wasted money on expensive pills and eye drops not until I discovered thisUSAOrganic remedy that reverses glaucoma, cataract, and cures severe eye problems like

Glaucoma, Short- Sightedness (Myopia), Far- Sightedness (Hyperopia), Lazy Eye (Amblyopia), Cross-Eye (Strabismus), Eye Strain, Macular Degeneration, Cataracts, Astigmatism, Old-Age Sight, Light Sensitivity, Diabetic Retinopathy and other various eye problems.

In fact, this Organic Remedy has now been used by over 642 Nigerian men and women, with remarkable success to improve vision and restore eyesight in few weeks.

And the best part is, it works whether youre 8 or 80 years old.

You can Check Out the USA Organic Solution Here >>http://bit.ly/purxcnws

If youve noticed that your eyesight keeps getting worse, even after spending money on countless number of drugs and eye drops

If youre concerned about whether the eye problem will ever stop, and you would like to put an end to it before you lose your eyesight completely

If you ever get embarrassed or frustrated at your inability to read or see things properly

If youre experiencing blurry vision, blind spot, or any kind of issue with your vision

And if you want a scientifically proven way to correct your failing eyesight and achieve perfect 20/20 vision in as little as few weeks

Then Read every single word on this page, because I promise you will be able to improve your eyesight tremendously with this USA Discovered Organic Remedy.

You see, I was once in your shoes, I used to battle with severe eye problems that made me had blurred vision, dry itchy and red eyes.

But my eye doctor told me I could only live with it, so my optician kept on recommending eye glasses lens (or spectacles) so I could manage it to improve my vision.

But, as time went by this became ineffective, caused several eye irritations and also negatively affected my self esteem.

3 years later, my eye condition had worsened after several eye exams, I was diagnosed with glaucoma in the right eye.

In my Situation, several solutions like eye drops, pills and surgery was recommended.

Eye surgery which was the longest time treatment was really expensive, and even comes with its own side effects after several months or years.

So, I decided to start using eye drops just so I could manage to see because at this point, I was literally going blind.

You can Check Out the USA Discovered Organic Solution Here >>

The whole story was finally different when I came in contact with myOld Secondary School FriendFRANK, who is now an optician based in the USA.

He told me the secret behind many Eye drops and recommended glasses.

He Revealed How Research Has Proved That Wearing Lenses and Contacts May Finally Destroy Our Eyesight Over Time.

Not Only that, he also Revealed the secret of most Pharmaceutical Companies that Produces Eye Drops to me, how they are reaping people off their hard earn money when trying to regain their eyesight.

First, most MLM and Pharmaceutical companies sell very expensive prescription drugs and glasses that takes a very long time to work.

They want you to keep coming back to buy more and more drugs from them, to make more money out of you because they know it will take forever for it work.

Another way they cheat people is that, they try to keep people suffering from eye problems away from finding out other safe, natural and Easy ways to cure glaucoma, cataracts, myopia and other eye problems without using their expensive drugs or going for surgery anymore.

So, he Finally revealed to me that there is an Organic Solution that Gives PERMANENT CURE TO ALL EYE PROBLEMS which helps reverse Glaucoma, Cataract, Myopia, Aged Cross-Eye (Strabismus), Eye Strain, Macular Degeneration, Astigmatism, Old-Age Sight, Light Sensitivity, Diabetic Retinopathy and other various eye Issues without any side effect whatsoever.

Most of these cases he has handled in the eye specialist clinic he works with in USA, and his patients improved their eyesight, and they never had to wear glasses or go for expensive eye surgery again.

You Too Can Check Out the USA Organic Remedy I am Talking About Here ->

http://bit.ly/purxcnws

But there is a Problem,

This solution is very rear to Find in Nigeria because it can only be imported from the USA.

At first, I was shocked and surprised.

But he told me the exact plant extracts contained inside this Organic Solution, and how they improve overall eyesight health and restores vision.

I quickly pleaded with him to help me send a complete supply it.

The next morning, I quickly sent the money to him.

To my surprise, in less than 3 weeks of using it, it was almost like a miracle to my eyesight problem and it helped improve my vision.

My eyes became crystal clear, my vision was never blurry again, and I started to feel that my glaucoma was a thing of the past.

Click Here to get access to the Herbal Remedy that helps you cure glaucoma, cataract, near-sightedness in few weeks!

http://bit.ly/purxcnws

After It worked for me,

In order to be sure how effective this USA Organic Solution is, I also Introduced it to some of my co workers who are battling with different eye issues.

They also got it, took it as prescribed and in less than 1 month, most of them came back with great testimonies Sharing the good news of how this Organic Product miraculously clear their eyesight issues and help them regain their sight completely.

After some months, I also went to my eye clinic for checkup, and what I discovered was amazing.

My Eye Doctor took me through some test and told me that there is great improvement in my eyesight and that most of the previous problems can no longer be found.

I was filled with Joy in my heart.

I was happy I will not be using glasses again.

Check Out the Organic Remedy Here

http://bit.ly/purxcnws

HERE ARE TESTIMONIES FROM SOME NIGERIANS WHO HAVE USED IT TO CURE DIFFERENT SIGHT PROBLEMS

Mrs Amaka in LAGOS is one of those that used this Organic Solution to Cure her Eye Issue Permanently and Here is what she says

Amaka Edith

A Mother and a Teacher.

This is the BEST Answer I know to Achieve perfect 2020 vision

My name is Amaka Edith

And I know how it feels not to have a 20/20 vision because I have used glasses for years, used eye drops, drank eye tea & taken enough meds.

I found it difficult to see clear unless I use drops, everything always looked blurry

In fact, it got to a point I could not see what I am reading or writing. It affected my work as well.

UNTIL my U S based Doc friend introduced me to this Newly Discovered Organic Solution that made my vision so sharp that I can see the tiniest of the article from far away.

Thank You Doctor. For Showing Me the Way of Light & Vision.

I recommend this Solution to anyone who is serious about clearing any sight issues.

Another Great Testimony from Bar. Jubril Aina, Abuja

I once had a Glaucoma and Cataract, when I was Introduced to this Solution from my USA Based Friend.

He said it was a newly discovered solution for all sight issues.

After using it for some weeks, I was surprise with the changes in my Eye, I have to Call my eye doctor for a test and what he said got me surprised.

Right now, I am 67year old and I can read anything, even the tiniest letter.

This USA Newly discovery is the Solution We are Looking for..

If You Will Also Like to Cure Any form of Eye Problem, be it Glaucoma, Cataract, Myopia, Aged Cross-Eye (Strabismus), Eye Strain, Macular Degeneration, Astigmatism, Old-Age Sight, Light Sensitivity, Diabetic Retinopathy OR any other various eye Issues without any side effect whatsoever.

Go Here to Check the New USA Discovered Organic Remedy

http://bit.ly/purxcnws

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Newly discovered: The USA organic solution that cures cataract, glaucoma, blurry vision, other eye problem ... - Daily Post Nigeria

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CooperVision Becomes Global Patron of International Agency for the Prevention of Blindness – InvisionMag

February 20th, 2020 3:47 pm

(PRESS RELEASE) SAN RAMON, CA CooperVision has become a global patron of the International Agency for the Prevention of Blindness. The company becomes part of a select group of leaders including Allergan, Bayer, Novartis and Standard Chartered Bank that supports IAPB at the highest level to help achieve universal access to eye health.

As part of the relationship, CooperVision and IAPB will collaborate to bring greater awareness and action to the growing prevalence and severity of myopia in children worldwide. A seminal 2015 report on the issue from the World Health Organization (WHO) declared that myopia and high myopia are increasing globally at an alarming rate, with significant increases in the risks for vision impairment from pathologic conditions associated with high myopia.

CooperVision has a heritage of addressing widespread refractive issues such as astigmatism and presbyopia. More recently, we have taken on even greater challenges such as childhood myopia, not only correcting it but also successfully slowing its progression, said Daniel G. McBride, president of CooperVision. Even with the remarkable progress were making, no single organization can do this alone. Were optimistic about what our new partnership with IAPB will mean for millions of children, adults and families worldwide.

IAPB are excited about the opportunity to partner with CooperVision to create sustainable and lasting change in eye health, including addressing the substantial global increase in myopia, said Peter Holland, chief executive, IAPB. The leadership, insight and innovation of our Patrons regularly unearth new approaches, models and alliances for greater collective and individual impact. By working together, we exponentially increase our abilities to confront and overcome vision impairment issues.

In addition to its IAPB patronage, CooperVision contributes significant funding, knowledge and time to a range of eye health-focused organizations every year. These include being a founding member of the Global Myopia Awareness Coalition, a Global Platinum sponsor of Optometry Giving Sight, and partner in Our Childrens Vision. As part of its corporate responsibility initiatives, CooperCompanies is also aligned with the United Nations Sustainable Development Goals, concentrating on good health and well-being, responsible consumption and production and complementary partnerships.

CooperVision develops a range of products designed to aid eye care professionals. Silicone hydrogel soft contact lens brands such as Biofinity and clariti 1 day are worn by millions worldwide. Its myopia care portfolio includes advanced lenses such as Paragon CRT and Procornea DreamLite designed for overnight wear (orthokeratology), as well as innovations such as MiSight 1 day contact lenses for slowing the progression of myopia in children (8-12 years of age at the initiation of treatment).

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CooperVision Becomes Global Patron of International Agency for the Prevention of Blindness - InvisionMag

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Darren from Weston lost his sight in 2016 | Latest Weston-super-Mare and Somerset news – Weston Mercury

February 20th, 2020 3:47 pm

PUBLISHED: 16:00 20 February 2020

Mellissa Dzinzi

Visually impaired man Darren Palmer treated unfairly by pure gym, pictured with his guide dog. Picture: MARK ATHERTON

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The 44-year-old, who lives with his wife in Weston, has had to adjust to life with his guide dog and has even lost friends as a result of his visual impairment.

At the beginning of this year, Darren gained his confidence back and joined Pure Gym, in Gallagher Retail Park, despite his impairment.

He said: "It started around 2012, there was a big black spot in my eye which kept coming and it got worse over time.

"I have a little bit of vision in my left eye. The doctors did what they could to save my sight. It could have been worse."

Darren said it took a long time for doctors to diagnose his condition and he found it increasingly difficult to go out with friends.

He added: "Before the surgery, I used to walk into people, and it got to a point I couldn't go out with my friends.

"I got put on a pub watch once because they thought I was drunk, I even showed them my card. After that, I got a symbol cane.

"As soon as I had a cane, I felt like a vulnerable person.

"I took me a while to come to terms with losing my sight.

"People assume you are completely blind and you can't do anything."

Exercise is one of the activities which has helped Darren to regain his independence.

He said: "I have equipment at home, but I wanted to join the gym. I had my induction and the manager was more than happy for me to use the gym and for me to have my guide dog with me.

"I've lost friends from it - people don't know how to act or they avoid you. It's quite sad."

Darren is 'physically abled' despite his visual impairment.

He has a guide dog, but this often attracts unwanted attention from members of the public who want to stroke the animal.

This can distract the dog, which could put Darrren in danger.

Small issues which would not usually pose a problem can also be a big challenge to Darren, such as cars parking on pavements.

Darren said: "It's a silly little thing I used to do when I used to drive.

"The guide dogs are trained to walk on the path and on the road.

"They might go around the cars and onto the road, which can be dangerous.

"I had two little kids in McDonald's asking questions about the dog.

"It was lovely because some kids really take an interest, which is nice.

"Some children will point to the dog and say he's a special dog because they've learnt about guide dogs at school.

"I get caught on the school bus sometimes and it can be a challenge when the children try to climb over the dog. I have to remind people not to distract him.

"He can get into small spaces on the bus and trains. I never used to suffer from claustrophobia till I lost my sight, especially on trains. People stand over the dog and crowd him."

Since his diagnosis, Darren has had a great deal of support from Vision North Somerset.

A number of shops and supermarkets also run a lanyard scheme which enables people with hidden disabilities to get help.

For anyone who is struggling with visual impairment or going through the same situation as Darren, he said there is help out there.

He added: "There is help and support. The help I received from Vision North Somerset was priceless. They went above and beyond.

"Places like Tesco have a lanyard scheme, which I think is fantastic - it indicates to the staff you may need help.

"If you see someone struggling, don't be afraid to ask the person to help them. They're probably just afraid to ask for help."

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Darren from Weston lost his sight in 2016 | Latest Weston-super-Mare and Somerset news - Weston Mercury

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Humour has been my defence and my saving grace – AOP

February 20th, 2020 3:47 pm

Considering the battering that my right eye has taken, it is doing pretty well. I have fairly good long-distance vision. I switch between a contact lens and very thick glasses.

Some of my material as a comedian is based on sight loss. As I found my voice as a comedian, it has developed into all manner of things. Now I just tend to gossip on stage. I always try and justify it by saying that because I have spent a lot of my life in hospital waiting rooms, a good distraction is a little bit of gossip.

My first show, A Poke in the Eye, was about the year I lost my sight when I was 21. It was a complex journey. The show was picking out the most interesting parts of that time. My mum, dad and my brothers were main characters in it.

I thought I would use what was a negative experience and turn it into something positive. It is your unique outlook on the world that people find funny. You need to tap into that as much as you can. Comedy is one of the few things I have found that I am good at. What better way to spend your time than with a group of people having a laugh.

You have to be resilient. You have to put up with tough audiences. But the highs are so great that you put up with the lows. I did an Edinburgh Fringe run of my third show, Eyecon, on a Saturday and it was packed full with a really young, rowdy audience. They were an absolute riot and it just felt like a party.

There are loads of times where shows havent gone well. I will try a new joke or a new subject and it just dies. No one finds it funny. You have to take it all with a pinch of salt. Sometimes they are not the audience for you.

It is your unique outlook on the world that people find funny. You need to tap into that as much as you can

Any comedian who is giving it their all I admire. My idol was always Joan Rivers. She was one of the first female comedians ever. I got compared to her in Edinburgh and there is no greater compliment.

You will always get a little bit nervous. It would be weird if you didnt. Sometimes I am really tired and I have had a long day. Without that adrenalin, I would have been totally flat. You turn that nervousness into energy. As soon as you get your first laughs and things start to flow, youre away.

I decided to support the International Glaucoma Association because there isnt much awareness around young people and glaucoma. It is one of the biggest causes of sight loss and it is a condition that can be controlled. I am very much a believer in prevention rather than cure.

Humour has been my defence and my saving grace. When things have been properly tough, I have found a way to laugh it off. The only alternative is to cry. I know how I want to live my life.

Georgie Morrell is a stand up comedian. She supported the International Glaucoma Associations Glaucomasters campaign during National Eye Health Week 2019. For more details about upcoming gigs visit her website.

Image credit: Steve Ullathorne

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Men with ED seeing blue over rare Viagra side effect – Windsor Star

February 20th, 2020 3:47 pm

A study in the journal Frontiers in Neurology, is shedding light on a rare side effect of the erectile dysfunction drug sildenafil. The active ingredient in Viagra, sildenafil can cause the vision in some men to be tinted blue.

The report refers to the cases of 17 men who visited a hospital in Turkey with vision problems 24 hours after taking the drug. They reported blurred vision, sensitivity to light, reduced eyesight and changes to colour perception which included, intensely blue-coloured vision, a side effect medically known as cyanopsia.

Other reports of vision changes included red-green colour blindness (where green and red colours appeared brownish).

According to Science Live, its well known that sildenafil can cause temporary vision changes (like cyanopsia) that can last for a few hours. But persistent vision changes are much more rare. In the case studies examined in the report, researchers say that the mens vision returned to normal after 21 days.

In a statement, study author Dr. Cneyt Karaarslan of the Dnyagz Adana hospital in Turkey, told EurekaAlert that for the vast majority of men, any side effects [of sildenafil] will be temporary and mild. She said that she wanted to highlight that persistent eye and vision problems could be encountered by a small number of users.

One possibility for the blue vision could be that a small number of the population is unable to break sildenafil down and eliminate it from their body efficiently. This would lead to high concentrations of the drug in the bloodstream compared to other users and hence, the blue-tinted vision.

Science Live says that sildenafil works to treat erectile dysfunction by inhibiting an enzyme called phosphodiesterase 5 (PDE5) that helps to regulate blood flow to the penis. But the drug also inhibits a related enzyme thats found in cells at the back of the eye. Its believed that in high doses, this could lead to buildup of a molecule that can be toxic to retinal cells.

For the men in this study, it was their first time taking the erectile dysfunction drug. They began with the highest dose, so starting with a lower dose could have less severe side effects. In a press release, the researchers noted that the high dose was likely because the men were under medical supervision in the study. Otherwise the amount of the drug prescribed would have likely been lower.

While the idea of vision changes is a bit disconcerting, seeing colour as a side effect of taking Viagra is rare. Still, if you are looking to firm things up, its best to consult your doctor to decide on the treatment thats best for you.

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The eyes have it: A trip to the optician – even if you don’t wear glasses – can give you early warning of a range of serious illnesses – The Sunday…

February 20th, 2020 3:47 pm

As William Shakespeare once wrote, the eye is the window to the soul. But if the truth be told, the eyes are actually a porthole to so much more.

In fact, a simple eye test could save your life. Stats show that only one in five people know a routine visit to the optician not only examines your eyesight, but can also assess the general health of your eye and give a clear view of warning signs for a range oflife-threatening illnesses.

So, a visit to the opticians really is more essential than you might think.

Your eye is the one part of the body where we can see blood vessels in their natural habitat without being invasive, Willis Wilkie, lead optometrist at Wilkie & Rider Opticians, said.

And these can be key in spotting a whole host of health conditions.

Sometimes we can spot something so serious that it actually saves someones life.

Willis, who has been a practicing optician for almost 10 years, said its all to do with the mechanics at the back of the eye.

Tiny blood vessels and nerves can hold telltale signs that something is untoward inanother part of the body.

The blood vessels can change when the body is experiencing certain conditions. For example, they can leak, or the optic nerves can be swollen, or there can be a mass at the back of the eye and all these tell us that something is wrong, Willis explained.

Williss career as an eye specialist came after years spent watching his father in the profession.

But even in just one generation, he says there have been significant developments in the techniques and technology used in the industry.

Eye tests these days are much more advanced than they were 40 years ago, Willis said. We still have the old eye chart with the letters, but we also have digital retina photography which ensures detail, accuracy and repeatability.

It gives us a much better view so we can detect any eye health problems, as well as symptoms of other health conditions.

We also have the air puff test and drops we can use in the patients eyes to make the pupils bigger which helps make our job a little easier.

In the past, we couldnt do much about that. Now, we have options.

Having your eyes tested is recommended every two years until the age of 60, then annually.

And Willis says, even if you dont wear glasses or think you might need glasses, its always a good idea to schedule an appointment, just to make sure everything is as it should be.

Most people dont come to us unless they feel there is a problem with their sight, like theyre getting headaches at the computer, or they are struggling to read things at a distance.

But eyes are very important and we should be having them tested to make sure there are no signs of problems, such as glaucoma, cataracts or macular degeneration.

Or, of course, more serious illnesses which can be picked up simply by looking at the back of the eye.

From diabetes, high blood pressure and cardiovascular disease to arthritis and even tumours, theres so much we can see.

So if youre worried about your eyes, its probably wise to see an optician first before calling your GP. Hopefully we can work out what the problem is and spot any other health issues while were there.

Its important to remember that when diabetes is in its early stages, diabetic retinopathy does not usually cause any noticeable symptoms, so you may not even know you have it.

However, an eye test can detect the condition before you notice any changes to your vision.

Diabetes can affect small blood vessels in the eye, damaging the retina, which is vital for sight. And an eye test can pick up tiny leaks from damaged blood vessels.

It is not uncommon for someone to be informed that they may have high blood pressure as a result of observations made by their optician during a routine eye test.

When examining the retina, they can see whether or not the blood vessels are narrowed or are leaking.

Having high cholesterol which can lead to heart problems or a stroke doesnt usually have any symptoms.

However, it can cause blockages in any of the bodys blood vessels, including those in the eyes. Opticians can spot little lumps of cholesterol. These can block blood vessels resulting in short episodes ofvisual loss.

Some people may be aware that eye tests can detect cancers of the eye such as melanomas, but they can also detect signs of brain tumours.

Swelling of the optic nerves can be visible during an eye test, and can indicate a brain tumour is present.

Autoimmune forms of the disease, like rheumatoid arthritis, as well as causing inflammation in your joints, can also cause inflammation in your eyes.

This can commonly cause dry eye, or occasionally more serious conditions such as inflammation of the iris.

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How low oxygen levels in the heart can cause arrhythmias – Futurity: Research News

February 20th, 2020 12:46 am

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New research reveals the underlying mechanism for a dangerous heart disorder in which low oxygen levels in the heart produce life-threatening arrhythmias.

The discovery, made with human heart muscle cells derived from pluripotent stem cells, offers new targets for therapies aimed at preventing sudden death from heart attack.

Our research shows that within seconds, at low levels of oxygen (hypoxia), a protein called small ubiquitin-like modifier (SUMO) is linked to the inside of the sodium channels which are responsible for starting each heartbeat, says Steve A. N. Goldstein, vice chancellor for health affairs at the University of California, Irvine and professor in the School of Medicine departments of pediatrics and physiology and biophysics.

And, while SUMOylated channels open as they should to start the heartbeat, they re-open when they should be closed. The result is abnormal sodium currents that predispose to dangerous cardiac rhythms.

Every heartbeat begins when sodium channels open and ions to rush into heart cellsthis starts the action potential that causes the heart muscle to contract. When functioning normally, the sodium channels close quickly after opening and stay closed. After that, potassium channels open, ions leave the heart cells, and the action potential ends in a timely fashion, so the muscle can relax in preparation for the next beat.

If sodium channels re-open and produce late sodium currents, as observed in this study with low oxygen levels, the action potential is prolonged and new electrical activity can begin before the heart has recovered risking dangerous, disorganized rhythms.

Fifteen years ago, the Goldstein group reported SUMO regulation of ion channels at the surface of cells. It was an unexpected finding because the SUMO pathway had been thought to operate solely to control gene expression in the nucleus.

This new research shows how rapid SUMOylation of cell surface cardiac sodium channels causes late sodium current in response to hypoxia, a challenge that confronts many people with heart disease, says Goldstein. Previously, the danger of late sodium current was recognized in patients with rare, inherited mutations of sodium channels that cause cardiac Long QT syndrome, and to result from a common polymorphism in the channel we identified in a subset of babies with sudden infant death syndrome (SIDS).

The information gained through the current study offers new targets for therapeutics to prevent late current and arrhythmia associated with heart attacks, chronic heart failure, and other life-threatening low oxygen cardiac conditions.

The National Institutes of Health funded the study, which appears in Cell Reports.

Source: UC Irvine

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US FDA Grants Orphan Drug Designation for Retrotope’s RT001 in the Treatment of Progressive SupraNuclear Palsy (PSP) – Yahoo Finance

February 20th, 2020 12:46 am

LOS ALTOS, Calif., Feb. 18, 2020 (GLOBE NEWSWIRE) -- Retrotope announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for its chemically-modified polyunsaturated fatty acid drug (RT001) for the treatment of Progressive SupraNuclear Palsy (PSP). Physicians collaborating with Retrotope have previously received approval from the FDAs Division of Neurology Products to test RT001 in Expanded Access trials of three patients having PSP, an orphan neurodegenerative disorder that causes progressive impairment of balance and walking; impaired eye movement, abnormal muscle rigidity; dysarthria; and dysphagia and eventual death.

PSP is a serious neurodegenerative disease that profoundly affects the quality and length of life in adults. Patients are typically severely disabled within 3-5 years of disease onset. It affects an estimated 17,500 adults in the US. In addition to the motor deficits noted above, affected individuals frequently experience personality changes and cognitive impairment. Symptoms typically begin after age 60 but can begin earlier. The exact cause of PSP is unknown, and is often misdiagnosed as Parkinson disease due to the similarity of symptoms in the early stage of disease. The cause of PSP is not known, but it is a form of tauopathy, in which abnormal phosphorylation and accumulation of the protein tau in the mid brain leads to destruction of vital protein filaments in nerve cells, causing their death. Most cases appear to be sporadic as an acquired tauopathy and there is no approved drug therapy. A regionally specific increase in lipid peroxidation has been observed in PSP and mitochondrial structures and functions are compromised, leading to profound oxidation damage.

RT001 is a chemically stabilized fatty acid that confers resistance to lipid peroxidation in mitochondrial and cellular membranes via a novel mechanism. RT001 has been shown to decrease levels of lipid peroxidation in PSP patient mesenchymal stem cells, and restore mitochondrial structure and function to damaged cells. As RT001 is distributed, as an essential fat, throughout tissues in human, it is expected to lower the amount of lipid peroxidation, restore normal mitochondrial function and prevent mitochondrial cell death.

Robert Molinari, Ph.D. CEO of Retrotope commented: We want to sincerely thank the FDAs OOPD for this designation which allows us accelerated review and more flexibility in pursuing this indication. We are also grateful to the researchers, patients and clinicians whose work contributed to the results supporting our filing an investigational new drug (IND) application to FDA in this terrible disease.

Peter Milner, MD, Chief Medical Officer of Retrotope, added, PSP is a disease involving modification and dysfunction of tau protein. RT001s mechanism of action both lowers lipid peroxidation and prevents mitochondrial cell death of neurons which is associated with disease onset and progression. Also RT001 has a synergistic downstream benefit in the pathophysiology of PSP. This orphan designation encourages clinical trials and rapid review of data from trials to treat this intractable disease.

About the Orphan Drug ActThe US FDA Orphan Drug Act (ODA) provides orphan designation for drugs and biological products to treat a rare disease or condition upon request of a sponsor. Orphan drugs are usually defined as those products intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.

About RT001RT001 is a patented, first-in-class, orally available D-PUFA, a deuterated polyunsaturated fatty acid, that incorporates into mitochondrial and cellular membranes and stabilizes them. Retrotope and others have discovered that lipid peroxidation, the free-radical damage of polyunsaturated fats (PUFAs) in mitochondrial and cellular membranes, may be the primary source of cell death in several degenerative diseases. The presence of D-PUFAs (RT001) can help protect (fireproof) against this attack and potentially restore cellular health.

Story continues

About RetrotopeRetrotope, a privately held, clinical-stage pharmaceutical company, is creating a new category of drugs to treat degenerative diseases. Composed of proprietary compounds that are chemically stabilized forms of essential nutrients, these compounds are being studied as disease-modifying therapies for many intractable diseases, such as Parkinsons, Alzheimers, mitochondrial myopathies, and retinopathies. RT001, Retrotopes first lead candidate, is being tested in clinical trials for the treatment of Friedreich's ataxia, a fatal orphan disease; and in a fatal, childhood neurodegenerative disease called Infantile Neuroaxonal Dystrophy, and now in PSP which is also fatal. Expanded Access trials calibrating endpoint effects of RT001 in ALS, PSP, Huntingtons disease, and others are also underway. For more information about Retrotope, please visit http://www.retrotope.com.

https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Progressive-Supranuclear-Palsy-Fact-Sheet

SOURCE: Retrotope, Inc. 4300 El Camino Real, Suite 201 Los Altos, CA 94022 650-575-7551

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The global cell expansion market is projected to reach US$ 42,837.11 Mn in 2027 from US$ 11,929.43 Mn in 2018 – Yahoo Finance

February 20th, 2020 12:46 am

The cell expansion market is expected to grow with a CAGR of 15. 6% from 2019-2027. Driving factors include increasing adoption of regenerative medicines, rising prevalence of cancer. However, the risk contamination during cell expansion is expected to hamper the market during the forecast period.

New York, Feb. 17, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell Expansion Market to 2027 - Global Analysis and Forecasts By Product ; Cell Type ; Application ; End User, and Geography" - https://www.reportlinker.com/p05862085/?utm_source=GNW

Cancer is one of the major cause of human death worldwide.In recent years, the cases of cancer have been increasing tremendously and the trend is anticipated to remain the same in the upcoming years.

According to the World Health Organization in 2018, approximately 9.6 million deaths across the globe were due to cancer. Furthermore, the National Cancer Institute predicted that in 2018, approximately 1,735,350 new cancer cases would be diagnosed in the US.

Changes in lifestyle have resulted in more exposure to oncogenic factors.Cancer can be cured if diagnosed and treated at an initial stage.

Cancer sequencing using next-generation sequencing (NGS) methods provides more information. Additionally, cell expansion related procedures also aids in research, diagnostics and treatment of cancer.Furthermore, Asia Pacific region is also facing the problem of the growing prevalence of cancer.The top 15 countries with Cancer prevalence are Japan, Taiwan, Singapore, South Korea, Malaysia, Thailand, China, Philippines, Sri Lanka, Vietnam, Indonesia, Mongolia, India, Laos, and Cambodia.

According to the National Institute of Cancer Prevention and Research (NICPR), in 2018, in India, total deaths due to cancer were 784,821.

The global Cell Expansion market is segmented by product, cell type, application, end user.Based on product, the cell expansion market is segmented into consumables and instruments.

In 2018, the consumables accounted for the largest market share in the global cell expansion market by product.These consumables are essential components of any laboratory experiment hence they are expected to witness significant growth during the forecast period.

Based on cell type, the cell expansion market has been segmented into human cell and animal cell.Furthermore based on application the cell expansion market has been segmented into Regenerative Medicine And Stem Cell Research, Cancer And Cell-Based Research and Other Applications.

Based in end user market is segmented into Biopharmaceutical And Biotechnology Companies, Research Institutes, cell banks and others.

Some of the essential primary and secondary sources included in the report are the National Institute of Cancer Prevention and Research (NICPR), Association for Management Education and Development, Center for Cancer Research, International Society for Stem Cell Research (ISSCR), American Association of Blood Banks (AABB), National Institute of Cancer Prevention and Research and others.Read the full report: https://www.reportlinker.com/p05862085/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Combination Enfortumab Vedotin + Pembrolizumab Granted Breakthrough Therapy in Bladder Cancer – OncoZine

February 20th, 2020 12:46 am

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enfortumab vedotin-ejfv (Padcev; Astellas Pharma and Seattle Genetics) in combination with Mercks (known as MSD outside the United States and Canada) anti-PD-1 therapy pembrolizumab (Keytruda) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

It is estimated that approximately 81,000 people in the U.S. will be diagnosed with bladder cancer in 2020. [1] Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra. [2] Globally, approximately 549,000 people were diagnosed with bladder cancer in 2018, and there were approximately 200,000 deaths worldwide. [3]

The recommended first-line treatment for patients with advanced urothelial cancer is cisplatin-based chemotherapy. For patients who are unable to receive cisplatin, such as people with kidney impairment, a carboplatin-based regimen is recommended. However, fewer than half of patients respond to carboplatin-based regimens and outcomes are typically poorer compared to cisplatin-based regimens. [4]

Conditionally approvedEnfortumab vedotin-ejfv, a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer, was conditionally approved by the FDA in December 2019 based on the Accelerated Approval Program. [5][6]

Antibody-drug Conjugates or ADCs are highly targeted biopharmaceutical drugs that combine monoclonal antibodies specific to surface antigens present on particular tumor cells with highly potent anti-cancer agents linked via a chemical linker.

With seven approved drugs on the market, ADCs have become a powerful class of therapeutic agents in oncology and hematology.

Continued approval for enfortumab vedotin-ejfv in combination with pembrolizumab for the treatment of patients with advanced or metastatic urothelial cancer may be contingent upon verification and description of clinical benefit in confirmatory trials. [5]

The drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.

Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis). [5]

Breakthrough therapyThe Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. The designation is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints. In the case of enfortumab vedotin, the designation was based on the initial results from Phase Ib/II EV-103 Clinical Trial.

The FDAs Breakthrough Therapy designation reflects the encouraging preliminary evidence for the combination of enfortumab vedotin and pembrolizumab in previously untreated advanced urothelial cancer to benefit patients who are in need of effective treatment options, said Andrew Krivoshik, M.D., Ph.D., Senior Vice President, and Oncology Therapeutic Area Head, Astellas.

We look forward to continuing our work with the FDA as we progress our clinical development program as quickly as possible.

This is an important step in our investigation of enfortumab vedotin in combination with pembrolizumab as first-line therapy for patients with advanced urothelial cancer who are unable to receive cisplatin-based chemotherapy, said Roger Dansey, M.D., Chief Medical Officer, Seattle Genetics.

Based on encouraging early clinical activity, we recently initiated a phase III trial of this platinum-free combination and look forward to potentially addressing an unmet need for patients.

Clinical trialThe Breakthrough Therapy designation was granted based on results from the dose-escalation cohort and expansion cohort A of the Phase Ib/II trial, EV-103 (NCT03288545), evaluating patients with locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy-treated in the first-line setting with enfortumab vedotin-ejfv in combination with pembrolizumab.

The initial results from the trial were presented at the European Society of Medical Oncology (ESMO) 2019 Congress, and updated findings at the 2020 Genitourinary Cancers Symposium.

EV-103 is an ongoing, multi-cohort, open-label, multicenter phase Ib/II trial of PADCEV alone or in combination, evaluating the safety, tolerability, and efficacy in muscle-invasive, locally advanced and first- and second-line metastatic urothelial cancer.

Adverse eventsSerious adverse reactions occurred in 46% of patients treated with enfortumab vedotin-ejfv. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Discontinuing treatmentAdverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Specific recommendations

HyperglycemiaHyperglycemia occurred in patients treated with enfortumab vedotin-ejfv, including death and diabetic ketoacidosis (DKA), in patients with and without pre-existing diabetes mellitus. The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. In one clinical trial, 8% of patients developed Grade 3-4 hyperglycemia. Patients with baseline hemoglobin A1C 8% were excluded.

Physicians are recommended to closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia and, if blood glucose is elevated (>250 mg/dL), withhold the drug.

Peripheral neuropathyPeripheral neuropathy (PN), predominantly sensory, occurred in 49% of the 310 patients treated with enfortumab vedotin-ejf in clinical trials. Two percent (2%) of patients experienced Grade 3 reactions. In one clinical trial, peripheral neuropathy occurred in patients treated with enfortumab vedotin-ejf with or without preexisting peripheral neuropathy.

The median time to onset of Grade 2 was 3.8 months (range: 0.6 to 9.2). Neuropathy led to treatment discontinuation in 6% of patients. At the time of their last evaluation, 19% had complete resolution, and 26% had partial improvement.

Physicians should:

Occular disordersOcular disorders occurred in 46% of the 310 patients treated with enfortumab vedotin-ejf. The majority of these events involved the cornea and included keratitis, blurred vision, limbal stem cell deficiency and other events associated with dry eyes. Dry eye symptoms occurred in 36% of patients, and blurred vision occurred in 14% of patients, during treatment with enfortumab vedotin-ejf.

The median time to onset to symptomatic ocular disorder was 1.9 months (range: 0.3 to 6.2).

Physicians should monitor patients for ocular disorders and consider:

Skin reactionsSkin reactions occurred in 54% of the 310 patients treated with enfortumab vedotin-ejf in clinical trials. Twenty-six percent (26%) of patients had a maculopapular rash and 30% had pruritus. Grade 3-4 skin reactions occurred in 10% of patients and included symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. In one clinical trial, the median time to onset of severe skin reactions was 0.8 months (range: 0.2 to 5.3).

Of the patients who experienced rash, 65% had complete resolution and 22% had partial improvement.

Physicians should monitor patients for skin reactions, and consider:

Infusion site extravasationSkin and soft tissue reactions secondary to extravasation have been observed after the administration of enfortumab vedotin-ejf. Of the 310 patients, 1.3% of patients experienced skin and soft tissue reactions. Reactions may be delayed.

Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. One percent (1%) of patients developed extravasation reactions with secondary cellulitis, bullae, or exfoliation.

Physicians should ensure adequate venous access prior to starting enfortumab vedotin-ejf and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.

Embryo-fetal toxicityEnfortumab vedotin-ejf can cause fetal harm when administered to a pregnant woman.

Physicians should advise patients of the potential risk to the fetus and advise female patients of reproductive potential to use effective contraception during enfortumab vedotin-ejf treatment and for 2 months after the last dose. At the same time, they should advise male patients with female partners of reproductive potential to use effective contraception during treatment with enfortumab vedotin-ejf and for 4 months after the last dose.

Clinical trialA Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103) NCT03288545

References[1] American Cancer Society. Cancer Facts & Figures 2020. Online. Last accessed on January 23, 2020.[2] American Society of Clinical Oncology. Bladder cancer: introduction (10-2017). Online. Last accessed on January 23, 2020.[3] International Agency for Research on Cancer. Cancer Tomorrow: Bladder. Online. Last accessed on January 23, 2020.[4] National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. Version 4; July 10, 2019. Online. Last accessed on January 23, 2020.[5] Enfortumab vedotin-ejfv (Padcev; Astellas Pharma [package insert]. Northbrook, IL)[6] Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.

A version of this article was first published in ADC Review | Journal of Antibody-drug Conjugates.

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The 411 on Stem Cells: What They Are and Why It’s Important to Be Educated – Legal Examiner

February 20th, 2020 12:45 am

Medical treatment involving stem cells is an ever-growing, billion-dollar industry, so chances are you have heard about it in the news. Here in the U.S. and around the world, stem cells are being used in various therapies to treat a wide variety of health problems and diseases, including dementia, autism, multiple sclerosis, cerebral palsy, osteoarthritis, cancer, heart disease, Parkinsons disease, and spinal cord injury. Treatments for such health issues may sound promising, but the risk is many of those being sold and advertised arent yet proven to be safe and effective. This is why its so important to educate yourself before jumping into any kind of stem cell treatment.

To gain a better understanding of this new age of medical research, one must first understand what stem cells are and how they work. Stem cells are special human cells that can develop into many different types of cells. They can divide and produce more of the same type of stem cells, or they can turn into different functioning cells. There are no other types of cells in the body that have this natural ability to generate new cell types.

So where do stem cells that are used for research and medical treatments come from? The three main types of stem cells are embryonic (or pluripotent) stem cells, adult stem cells, and induced pluripotent stem cells.

Embryonic stem cells come from unused, in vitro fertilized embryos that are three to five days old. The embryos are only donated for research purposes with the informed consent of the donors. Embryonic stem cells are pluripotent, which means they can turn into any cell type in the body.

Adult stem cells are found in small numbers in developed tissues in different parts of the body, such as bone marrow, skin, and the brain. They are specific to a certain kind of tissue in the body and are limited to maintaining and repairing the tissue in which they are found. For example, liver stem cells can only make new liver tissue; they arent able to make new muscle tissue.

Induced pluripotent stem cells are another form of adult stem cells. These are stem cells that have been manipulated in a laboratory and reprogrammed to work like embryotic (or pluripotent) stem cells. While these altered adult stem cells dont appear to be clinically different from embryonic stem cells, research is still being conducted to determine if the effects they have on humans differ from actual embryonic stem cells.

Stem cells can also be found in amniotic fluid and umbilical cord blood. These stem cells have the ability to change into specialized cells like embryonic stem cells. While more research is being conducted to determine the potential of these types of stem cells, researchers already actively use these through amniocentesis procedures. In this procedure, the stem cells drawn from amniotic fluid samples of pregnant women can be screened for developmental abnormalities in a fetus.

The main difference between embryonic and adult stem cells is how they function. Embryonic stem cells are more versatile. Since they can divide into more stem cells or become any type of cell in the body, they can be used to regenerate or repair a variety of diseased tissue and organs. Adult stem cells only generate the types of cells from where they are taken from in the body.

The ability for stem cells to regenerate under the right conditions in the body or in a laboratory is why researchers and doctors have become so interested in studying them. Stem cell research is helping scientists and doctors to better understand how certain diseases occur, how to possibly generate healthy cells to replace diseased cells, and offer ways to test new drugs.

Clearly, stem cell research is showing great potential for understanding and treating a range of diseases and other health issues, but there is still a lot to learn. While there are some diseases that are showing success using stem cell treatments, many others are yet to be proven in clinical trials and should be considered highly experimental.

In our next article, various stem cell treatments, FDA regulations, and other stem cell hot topics will be explored. It will also focus on what to look for when considering stem cell therapies so people arent misled or misinformed about the benefits and risks.

For more information regarding the basics of stem cells visit these sites:

https://stemcells.nih.gov/info/basics/1.htm

https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117

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The 411 on Stem Cells: What They Are and Why It's Important to Be Educated - Legal Examiner

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The Challenge of Bioethics to Decision-Making in the UK – Westminster Abbey

February 20th, 2020 12:45 am

Past Institute lectures

A lecture for the Von Hugel Institute series Ethics in Public Life, 5th February 2015, given by Claire Foster-Gilbert, Director, Westminster Abbey Institute.

The context of the series of lectures of which this is one is ethics in public life, and I would like to start by taking some time to describe the creation and operation of Westminster Abbey Institute, and use it as a prism for our consideration of bioethics and decision making in the UK. I want to say a little bit about the sacred-secular divide which I do not see. Then the two thorny examples I will use in bioethics, when I come to them, will be embryology and assisted dying.

Westminster Abbey Institute was launched in November 2013 to revitalize moral and spiritual values in public life, working with the public service institutions around Parliament Square, and drawing on its Benedictine resources of spirituality and scholarship.

Westminster Abbey sits on the south side of Parliament Square, with the Judiciary in the form of the Supreme Court on the west side, the Executive in the form of Whitehall on the north side, and the Legislature in the form of the Houses of Parliament on the east side. The Institute is the Abbeys answer to the question: what is it bringing to public service and how can it support those in public office?

We knew, when we started, what we were not: a think tank, part of the commentariat, a campaigning organisation, nor a fawning courtier. Nor were we apologists for religion in the public square. The Abbey is already more integrated than that. There is no sense of a sacred-secular divide, and as I go about my work as Director I feel none between my work and that of the public service institutions around the Square. The similarity is that we are identifying at the heart of the Parliament Square endeavour a sincere wish to support the good, to serve society, to make things better in the world. And in that sincere wish I see spirit moving, hearts opening, minds analysing, bodies acting, as a holistic, responsive flow to the call of public service.

I am not naive: the motivation to serve the public and the vocation to public service are not pure. In amongst the good wheat of service are the tares of motives such as selfish ambition, personal gain, fame, and the needy weakness of human nature to be recognised and rewarded. I see those other motives, but I know them for my own also, so am in no position the Abbey Institute is in no position, lets be clear to judge or condemn them. Like the parable, we leave that till the harvest. And meanwhile, by supporting the good, believing in the motives that are for service, recognising and applauding the rightness in the work around the Square, the murky tares, if I may torture the analogy beyond its capability, melt away. We hope.

I see a wholeness, then, responding to a call to serve. The deeper the response the more effective and lasting it will be and here is a place where our religion makes a specific contribution. The further back into God it reaches, the more effective and lasting and good the call to public service will be. I call it God. Spirit, depth, the swirling deep movement of creativity, the meditation of the soul, the rest before action. The further the archer draws back the bow, the further and truer the arrow will fly. It has been notable just how much of a longing for depth has shown itself in the people and institutions around the Square in the short time the Institute has been operating.

Our method is first to offer a Benedictine context. That is, we offer conversation that locates itself in stability, community and the conversion of manners. We will sit down with a group of, say, senior Civil Servants, or those tasked with offering professional development to MPs, or a group of Peers, and together we will devise a seminar for their department or group which will look at the good that the department or group is trying to do. What is significant and distinctive is that the psychological and philosophical location of the conversation is deep. That depth is also physically expressed by the Jerusalem Chamber where King Henry IV died and V became King, and the King James Version of the Bible was finalised, and so forth, where the seminars happen. Part of the Abbots and then the Deans lodging, a space where spiritual and worldly do not separate.

I was set a great example of how to do depth by Rowan Williams when he was the interlocutor for a series of four public conversations at St Pauls Cathedral, taking in turn global economy, ecology, governance and health, and asking the experts in those fields questions which immediately drew them into a consideration of the philosophical and even theological underlying currents of the subjects. The bishops did a similar thing with genetics experts when they spent a day learning about the subject. They were really good questions, and ones that practitioners, officials, public servants often dont have time to ask, but they are the most important questions because they lead us into our spiritual humanity.

A really lovely example emerged yesterday when we were sitting around the table in the Permanent Secretarys office of a Government Department, discussing a forthcoming seminar for the Department. One of the Civil Servants spoke about how too often officials in the Department will apply formulaic approaches, such as the benefit-cost ratio, in a way that masks or even undermines vital human qualities such as empathy and humility, and we will look at this in the seminar. Importantly, the words and the disposition came from the Civil Servant, not from the Abbey Institute. We are not functioning on the Square to tell others what the Good is. It emerges in the encounter.

So the conversation is located in a Benedictine place (in a way, for a short while, that Permanent Secretarys office became a Benedictine space). First, it is stable, it is safe here, and here is not going to go away, its an historical place where we can feel our own passing, gain a perspective on our place in history. Second, it is a place of community, which means that we are gathered in goodwill together, seeking the good together, united in our efforts and made companions in our purpose, not by any means agreeing with each other but feeling safe with each other. As a community of goodwill we feel it is safe to get things wrong, to take time to form conscience, to work things out. And of course we operate to the Chatham House rule. Third, we are about the conversion of manners. We expect transformation to take place though we dont necessarily know what it will be. Broadly, though, borrowing from Philip Shepherd, we will be looking for moves:

And I dont mind admitting that this transformation is probably only realised after the talking is over and everyone has gone to evensong and then wandered around the Abbey in the semidark and silence of the close of the day and had a glass of wine back in the Jerusalem Chamber!

In agreeing that we are a community of goodwill seeking to articulate the good I have offered an analogy from sailing that works well. A Government Department can be imagined as a sailing boat. At the helm stands the Permanent Secretary, who, like all good helmsmen, seeks never to steer the boat more than five degrees either side of the compass direction upon which the boat is set. Civil Servants in the Department form the crew, from the navigator who must know the course and ensure the helmsman anticipates obstacles, to the scrubber of decks who ensures no one slips up. All play their part in ensuring the boat remains shipshape and able to withstand the waves and the winds in travelling its appointed course.

The waves are the events of the nation and the world. They may be relatively calm or they may rise into steep and stormy mountains of water, threatening the stability of the boat.

The winds are public opinion, which can fill the sails of the boat and send it scudding on its chosen course. They can gust and buffet, interrupting the boats smooth journey. Or they can blow adversely, threatening to push the boat off course altogether.

Hence, the helmsman cannot simply hold the tiller fixedly. He or she must constantly respond and adjust to the wind and the waves, aiming to keep within five degrees either side of the compass direction or risk increasingly over-compensatory swings away from the course of travel.

The compass point towards which the boat is sailing is The Good. As such, it is not a destination; the journey is the thing, the direction of travel the concern, not the arrival.

By whom is The Good defined? It is true that the Government Minister is granted that responsibility and privilege by virtue of having been elected by universal franchise. But in defining The Good, Ministers have to have their Partys support. And of course the strength of the prevailing wind, public opinion, may be such as to determine a change of compass direction altogether. For the politician, public opinion will set parameters on what he or she can achieve. The great political leader will have a vision of the Good that transcends narrowminded concerns but retains Party support, and respects the parameters set by the prevailing wind of public opinion. The visionary and skilled politician will learn, quite possibly from his or her Civil Servants, about the art of tacking.

Because of course it is the helmsman and the crew who execute the tack, and any other sailing manoeuvres required. The Civil Service crew, having gathered the evidence sniffed the wind, watched the waves will need to be able to tell Ministers when their proposed direction of travel will not work: when, whatever the Ministers might want to think, their proposed direction is possibly not towards The Good. Thus the Good is sought by all.

And in passing, if one imagines Whitehall as a fleet of boats, those, too, will need to be taken into account by the helmsman. But and it is a wonderful sight sailing boats, journeying as a fleet in the same direction across the waves, subject to the same wind, stay uniform distances apart.

Having established a common concern with identifying the Good, seated in our Benedictine space, we then spend time as moral philosophers, looking at the specifics of the policy drivers for a given Government Department. Our analysis is rigorous, using the method I developed in the Centre of Medical Law and Ethics at Kings College, London, under Ian Kennedy, in the 1990s.

We use the three broad approaches that moral philosophers have taken over the centuries as they have sought to determine what is good. These we have called goal-based, duty-based and right-based, following Dworkinii, Botrosiii and Fosteriv. Very briefly and broadly, a goal-based thinker will see the good of an action in its consequences rather than in the content of the action itself; a duty-based thinker will look at the action and judge it according to preexisting moral rules; and a right-based thinker will judge the action according to the views of those most affected by it. The goal-based approach is valid insofar as it is the case that we rarely act without some end in view and it is right to consider whether that end is a good one. The goal-based approach is limited in that even very desirable goals should not justify actions which in themselves are intrinsically nasty. The ends are important moral considerations but they dont justify the means. Morality is not a mathematical exercise. The duty-based approach is valid in that it makes us think hard about what we are doing rather than merely why we are doing it, recalibrating the needle of our moral compass, making us morally sensitive rather than mathematically certain. The duty-based approach is limited because it can blind us to important consequences (Kant would have us truthfully respond to a murderer seeking her prey); and it is limited because it can make us arrogant: concerned only with our own place in heaven earned by doing the right thing, regardless of its effect or the views of others (the poor soul who will be murdered because Kant refused to tell a lie, or the patient who wants his life support switched off and we refuse to take a life). The right-based approach is valid because it requires us to listen to others, it makes us community-minded instead of purist. It is limited because on its own it would make someones request, for example, to take their life, right with no other consideration except that it is their wish.

All three approaches are needed. They conflict, they make us think, they require sensitive responses, honest appraisal, self-awareness because we will temperamentally favour one approach over the others, but taken together they form a three-legged stool that stands firm, if the legs are all of the same length, even on rocky ground.

And then comes the real challenge of bioethics. The Department of Health wants us all to live better for longer. But when does life begin and when does it end? I want in this third and final part of my lecture to explore the contemporary challenge of these questions by looking at two issues embryology and assisted dying that have been working their way around Parliament Square, with cases in the Supreme Court, policy development in Whitehall, and legislation or attempts at legislation in the Houses of Parliament.

Human fertilisation and embryology are scientifically complex and they are also, at every stage, morally sensitive. The challenge to Government and Parliament has been whether and how to draw these extraordinary scientific developments within a regulatory framework in a way that respects the science and does not ride roughshod over the sensitive moral questions, or ban the research and practice altogether. Having chosen the former course of action, what principles needed to underlie the regulatory framework?

Let us take a step back in time and thought. Let us bring the issue into our safe Benedictine space. Here we are allowed to think out aloud. We do not have to have a pre-determined position, but if we do, we wont be shouted down or assumed to be on the side of the devil.None need feel defensive. In this Benedictine space we are seeking the Good, aware that many have tried before us and God willing there will be many afterwards, all calibrating their moral compass and seeking to steer the boat no more than five degrees either side of the compass point, but having to allow, because of the wind of public opinion and the waves of ever changing events, that much leeway either side. We know we will not find perfect answers.

And now for the three-legged framework. From a goal-based perspective, we ask what embryology is for, and why it matters. Embryology is important as a cure for infertility, as a therapeutic response to currently incurable diseases using cell transplantation and, very recently proposed, eliminating mitochondrial disease altogether. Its goals, then, are for life: new life, and curing diseased life. No one, really, could argue with the goals of embryology. We would want the research and practice to be done excellently, so as to ensure these good goals were reached, but from a goal-based perspective, taken on its own, there can be no quarrel with it.

From a duty-based perspective, what does embryology involve? Here the moral questions start to bite. The first question must be about the status of the embryo itself. Because if the embryo has the same status as a human life, no matter how wonderful the goals are, no one would countenance destroying a human life to reach them, and embryology (which always involves destroying embryos) would fall at this moral fence.

The reasons you might regard the embryo as a human life are as follows: the embryo is formed from the fertilisation of an egg by a sperm forming a unique genome no one (if it is a person) was ever like it before, and no one will be ever again. We, each of us diverse people, were all embryos once. If we are to choose a point when life begins, the formation of the fertilised egg is certainly a definite stage one could choose.

The reasons you might not regard the embryo as human life are: the place of fertilisation is not the womb or the field in which the embryo is implanted, but at the base of the fallopian tubes. The embryo still has a journey to make to reach the womb and implant. (Some Shia teaching on this argues that life cannot be said to have begun until the seed, egg and field are all in place, ie at implantation.) During that journey, in the normal course of events, 70% of embryos do not reach the womb. It is during that journey that the all-important stem cells start to proliferate, hence the interest in the early, pre-implanted embryo, not the fetus in the womb. During that journey, the embryo may divide and become more than one fetus, hence genetically identical twins. These reasons may persuade you that it would be acceptable to see the early embryo not as human life but as potential life, and that its use therapeutically is acceptable. You may feel the goal-based tug: the status of the early embryo is in question, and the use of them therapeutically is so full of promise Should the duty-based consideration, that the embryo has independent moral status like that of a human being, give way?

What is important to recognise is that we do not say that the embryo has no status. The legislation has recognised its moral importance by regulating its use. But the law has accepted that the embryo is not the same as a human life.

From a right-based perspective, you cannot really make a judgement. The embryo cannot speak for itself. Is it fanciful to conduct a thought-and-feeling experiment predicated on the fact that we were all embryos once. Would we be happy to have been destroyed even before reaching the womb, to save another life or lives, or to create a new life? ??

The other right-based question relates to those who might benefit from stem cell or mitochondrial therapy: if they think of the embryo as having human status they may not want to benefit from such treatment. Healthcare practitioners may seek to be conscientious objectors.

The challenge to UK decision-making of embryology has been profound and I think, myself, that we have not done badly at it. Prior to this last development on mitochondrial DNA, the debates have been long and thoughtful, no speedy legislation was drawn up (except to prevent cloning), and the regulation is careful. In the UK, embryo research can take place but it is all regulated. (In the US, embryo research may not take place if it is federally funded; if you can pay for it yourself, you can do what you like!)

However, courts continue to be referred to as no legislation could possibly anticipate the science. It has turned out that the most fruitful source of embryonic stem cells has not come from embryos but from de-differentiated adult cells. Since however these de-differentiated cells, if placed in a womb, could theoretically grow into a clone of the person whose cell it was, this has had to be specifically outlawed and, much more recently, and potentially worryingly, a court has ruled that: The mere fact that a parthenogenetically activated human ovum commences a process of development is not sufficient for it to be regarded as a human embryo. This judgement opens the way to patenting the process of creating stem cells. It is potentially worrying since it arguably robs the embryo of its moral status. However, what is the status of a de-differentiated cell, which could originate from any one of the bodies in this room just by scraping our skin?

Is the very recent decision of the Commons to allow the process that removes diseased mitochondrial DNA from the offspring of mothers with the disease a case of slipping down a slippery slope into unethical waters? Is it the first step towards eugenics, since it eliminates the disease from the germ line permanently? Or is it an intelligent use of skills and techniques we have developed through carefully regulated embryo research, that will allow the cure of a vile disease?

Assisted dying, unlike embryo research, has not been made legal and given a set of regulations by which to abide. Despite its repeated return to Parliament and the apparent public support for a change in the law, none has happened, as yet. In practice, cases have been decided by the Courts and the number of cases coming to the Courts is only increasing. It is something of a sore point for the judges: they cannot turn cases away. All the time, as they see it, Parliament refuses to take the bull by the horn and create legislation, they are obliged to give judgements on a case by case basis that creepingly changes the law, and it is changed by lawyers not by democratically elected representatives of the public debating in public.

Before reflecting on the challenge to law and policy-makers that assisted dying has posed, let us once again step back into our Benedictine space, and we should pause here for a moment and recollect that the primary quality of that space is listening

And now conduct our analysis. Assisted dying is the act of making available to a person, who has expressly and competently asked for it, the means to take his or her life by their own hand.

From a goal-based perspective, one goal of assisted dying is to alleviate suffering. Another is torespect the autonomy of individuals. Another may be put more boldly: to end life deliberately.

From a duty-based perspective, principles of the sanctity of life and of respecting autonomy both raise their concerns, and conflict. How are they resolved?

From a right-based perspective, the principle of respect for autonomy trumps any duty of other individuals to save, sustain or end life. It is, simply, up to the individual. When polls are taken on the subject of assisted dying and euthanasia the vast majority of responses are in favour of it, on the grounds, though, that it is my life to do with as I please and who is any doctor to prevent me. But a law that permitted a solely right-based approach that the request should be granted simply because it had been made would be impossible to apply. It would be impossible to know if the person had actually asked for death, because they would be dead. Additional safeguards have to be included in any legislation, and these require that certain relevant professionals are satisfied that the conditions allowing assisted dying are met. This is not, then, a purely rights-based activity any more. Similar difficulties arise in seeking abortion - it is not, in the legislations, simply up to the mother whether or not the abortion takes place. She has to satisfy two doctors that she fulfils the criteria set by the law. The fact that doctors will very often sign the forms without questioning the mother, because they take a right-based approach in profoundly believing in her right to choose, is symptomatic of the challenge of lawmaking in areas of bioethics.

If the dying in question is assisted only, ie the person has to take the lethal substance themselves, this right-based problem is allayed. That is to say, we may be fairly sure that if the pink drink given by organisations such as Dignitas is drunk without assistance once it is put in the hands of the one seeking assisted dying, then he or she most definitely did want to die.

We cannot know what passes in their hearts however, and Mary Warnock has been worryingly at ease with the idea that it would be perfectly all right to seek euthanasia on the grounds that one felt a burden to ones family and friends. The wishes and needs of the community of that individual: family, loved ones, society are all included in the right-based approach, and what of these? Chaplains ministering to those receiving euthanasia in Holland speak of the devastation of families, resonant of the desolation of the families of suicides.

The most recent case that came to the Supreme Court was that of Nicklinson, Lamb and the Director of Public Prosecutionv. Nicklinson and Lamb were both almost entirely paralysed; Nicklinson from a stroke which left him able to blink only and Lamb from an accident that meant he could only move his right hand. Hence neither would be able to take the pink drink unaided, so both wished to be assisted to die without fear of prosecution of those who helped. The Director of Public Prosecution sought the freedom to decide on the matter of assisting suicide on a case by case basis.

In the Supreme Court, all the Law Lords agreed that Article 8 of the Human Rights Act (which is the right to a private life, to be overridden only in the case of threats to public safety or criminal acts) is relevant to the issue of assisting someone to die if it is their express wish. That is to say, domestic rulings can be made by way of interpretation of the Article in relation to assisted suicide. But while some Law Lords believed that it was a right for a person to be assisted to die if it was their express wish, according to Article 8, others did not. It was recognised that there was a fundamental incompatibility between the sanctity of life and autonomy. Several Law Lords argued strongly that the debate should be held in Parliament as the representative body of society, not judged upon by appointed Justices. And indeed there is yet another bill to allow assisted dying making its way through the House of Lords now. It has reached the stage where the Lords are working through more than 100 amendments, some of which are clearly intended to wreck the bill, whilst others provide clarification and strengthening of safeguards. And arguably the intellectual purity of the moral reasoning of the judges is a better place to turn to than the mess of Parliamentary debate. What a strange way for law on such a sensitive and controversial issue as the management of the dying process to be written: by the tug of war of differing factions and the compromise that will inevitably be reached if the bill is to succeed.

And yet, how are we to decide these matters that affect us all? I should like to finish, provocatively, with a lengthy quotation from a recent lecture delivered by one of the Justices of the Supreme Court, Lord Sumption.

To sum up, then. We have considered challenging and complex bioethical issues using the Westminster Abbey Institute approach of first, creating a Benedictine space of safety and stability, second, subjecting the matter to rigorous moral analysis and third, coming to a decision, which decisionmaking is the responsibility of the lawmakers and the policymakers. What I have not done is to offer absolute rules or principles which trump every other consideration. It is far better to be morally sensitive than to be morally certain. And so I am agreeing with Lord Sumption that, however fallible it may be, Parliament is the place to fashion legislation on these matters. We do well to attend to whom we put there.

(i) Philip Shepherd, New Self, New World: recovering our senses in the twenty-first century, (Berkeley: North Atlantic Books), 2010 (p 282)(ii) Ronald Dworkin, Taking Rights Seriously, 1977 (Harvard: Harvard University Press)(iii) Sophie Botros and Claire Foster, The moral responsibilities of research ethics committees, in Dispatches, 3:3, Summer 1993(iv) Claire Foster, The Ethics of Medical Research on Humans, (Cambridge: Cambridge University Press) 2001(v)R (on the application of Nicklinson and another) (Appellants) v Ministry of Justice (Respondent); R (on the application of AM) (AP) (Respondent) v The Director of Public Prosecutions (Appellant); R (on the application of AM) (AP) (Respondent) v The Director of Public Prosecutions (Appellant) 25 June 2014(vi) Lord Sumption, The Limits of Law, 27th Sultan Azlan Shah Lecture, Kuala Lumpur, 20 November 2013

Download a transcript of this lecture (PDF, 238KB)

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The Challenge of Bioethics to Decision-Making in the UK - Westminster Abbey

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Penn announces seven 2020 Thouron Award winners – Penn: Office of University Communications

February 20th, 2020 12:45 am

Four University of Pennsylvania seniors and three recent alumni have won a Thouron Award to pursue graduate studies in the United Kingdom. Each scholarship winner receives tuition for as long as two years, as well as travel and living stipends, to earn a graduate degree there.

Established in 1960 and supported with gifts by the late John Thouron and his wife, Esther du Pont Thouron, the Thouron Award is a graduate exchange program between Penn and U.K. universities that aims to improve understanding and relations between the two countries.

Penns seven 2020 Thouron Scholars are:

Daniel Brennan

Senior Daniel Brennan, of Miami, is a varsity oarsmen for Penns lightweight crew team majoring in history and political science, with concentrations in military history and political theory in the School of Arts and Sciences. As a United States Marine and past moderator of the Universitys Philomathean Society, he is an advocate for greater civil-military awareness. Brennan works on national security policy as a Student Fellow at the Perry World House and is writing his honors thesis on the development of counterinsurgency strategy during the Cuban War of Independence. He is a Benjamin Franklin Scholar and has worked on anti-hunger issues both as a Fox Leadership Fellow with the Catholic Archdiocese of Philadelphia and by organizing his crew teams meal-packing events. In the U.K., he plans to pursue a masters degree in military history.

Braden Cordivari

Braden Cordivari, of Elverson, Pennsylvania, is a 2018 graduate of the College of Arts and Sciences. He received his bachelors degree in classical studies and anthropology with a minor in archaeological science. Since 2015, he has continued to work at Penns excavations at the ancient Iron Age city of Gordion in Turkey. He spent the 2018-19 academic year as a John Williams White Fellow at the American School of Classical Studies at Athens completing a program of intensive study of Greek archaeology and history. His research interests include human/environment relationships in the past and the study of craft production through science-based methods. Cordivari plans to pursue a masters degree in archaeological science at the University of Cambridge.

Gregory Forkin

Gregory Forkin, of Philadelphia, is a 2019 graduate with a bachelors degree in mathematics, physics, and biology and a minor in chemistry. He was a University Scholar and a member of Phi Beta Kappa. Currently, he is conducting research in neuroscience under Professor Vijay Balasubramanian and is a teaching assistant in the Math Department in the School of Arts and Sciences. Forkin plans to pursue a masters degree in pure mathematics at the University of Cambridge.

Natasha Menon

Senior Natasha Menon, of Scottsdale, Arizona, is pursuing a major in philosophy, politics, and economics with a concentration in distributive justice and a minor in legal studies and history in the School of Arts and Sciences. Menon serves as president of the Undergraduate Assembly, through which she works to elevate the voices of marginalized communities on campus to effect change. She is also a Civic Scholar, and has volunteered at Moder Patshala, a Bangladeshi immigrant services center in Philadelphia, for three years. Menon plans to pursue a masters degree in international migration and public policy at the London School of Economics. Upon returning to the U.S., she hopes to pursue a law degree and engage in public service in Arizona.

Robert Subtirelu

Senior Robert Subtirelu, from Ronkonkoma, New York, is majoring in the biological basis of behavior and minoring in chemistry in the School of Arts and Sciences. A recipient of the 2019 Clinical and Translational Research Award, he has conducted research with the Perelman School of Medicines Department of Neurosurgery to investigate post-traumatic epilepsy. He works as a teaching assistant, volunteers with Wissahickon Hospice, and remains an active member of Penns Medical Emergency Response Team. He also founded and coordinated the activities of a not-for-profit organization that has established educational and nutritional programs internationally. Subtirelu plans to pursue a masters degree in clinical and therapeutic neuroscience at the University of Oxford.

Zachary Whitlock

Senior Zachary Whitlock, of Washington, D.C., is in the Vagelos Integrated Program in Energy Researchjoint-degree program, majoring in materials science and engineering in the School of Engineering and Applied Science and in earth science in the School of Arts and Sciences. Whitlock has workedon biomimetic functional materialswith Penn Engineerings Shu Yang Laboratory and internationally at the French Alternative Energies and Atomic Energy Commission. More recently, he worked at the intersection of industrial materials and environmental impact on the Kleinman Center for Energy Policy-funded project Fossil Fuels, the Building Industry, and Human Health. He is a 2020 Kleinman Undergraduate Fellow and Supported Student at the Water Center at Penn. He is planning to pursue a masters degree in environmental systems engineering at University College London and ultimately hopes to contribute to the sustainability and impact mitigation of projects reliant on ecosystem services.

Maia Yoshida

Maia Yoshida, of Madison, New Jersey, received her bachelors degree in 2018 in molecular and cell biology with a minor in fine arts. She is now a researcher in a bioengineering lab, engineering immune cells to better fight cancers. While at Penn, she researched the molecular mechanisms involved in neurodegenerative diseases and was a teaching assistant for a fine arts course on biological design. She also taught elementary school science at the Penn Alexander School in West Philadelphia. As the president of Global Brigades at Penn, she led fundraising efforts for sustainable development projects in Honduras. Yoshida plans to pursue a masters degree in STEM Education at Kings College London.

TheCenter for Undergraduate Research and Fellowshipsserves as Penns primary information hub and support office for students and alumni applying for major grants and fellowships, including the Thouron Award.

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Penn announces seven 2020 Thouron Award winners - Penn: Office of University Communications

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5 Questions: Robert Harrington on research, health equity and the gender gap in cardiology – Stanford Medical Center Report

February 20th, 2020 12:44 am

Last November, at the start of the American Heart Association 2019 Scientific Sessions in Philadelphia, cardiologist and current AHA presidentRobert Harrington, MD, sent out atweetto his 14,200 followers: No MANELS! There are no all-male panels at #AHA2019.

Within an hour, the post had amassed hundreds of likes and retweets, as scientists and physicians from all over the country chimed in to express their support. Outstanding! Lets continue to support our young women in STEM and to increase the number of #WomeninMedicine, replied a preventative cardiologist from USC. The best part? This wasnt hard for @AHAMeetings to accomplish. Because #WeAreEverywhere, a cardiologist who specializes in myocardial infraction also tweeted in response.

Harrington, the Arthur L. Bloomfield Professor in Medicine and chair of the Department of Medicine at Stanford, has shown a commitment to amplifying diverse voices and leveraging innovative technologies and policies to improve health equity. And its these values that drive his work at Stanford and the AHA. Recently, Lindsey Baker, communications manager in the Department of Medicine, spoke with Harrington about his views on technology and diversity in medicine.

1. Youve taken up several initiatives during your tenure as AHA president including health equity and diversity, and research. How did you choose these topics, and why were they important to you?

Harrington:One of the great things about being the AHA president is that you realize you have a big public platform. It provides an opportunity to think about the things that matter to you.

Im a clinician and a clinical researcher, so one of the key themes of my 2019 AHApresidential addresswas the idea that evidence matters that its really important to have an evidence base to guide what we do in clinical medicine, and in order to generate that evidence base we need to support research. And in order to support research, we have to think about health equity: How do we make research more approachable for people in communities where theyve been understudied and underserved?

We now include the word equitable in all of our goal statements. And we just recently announced our2030 impact goals, which emphasize how we improve overall whole person health in the U.S. and globally.

Were also committed to supporting young investigators. Right now, over 70% of all of our new research awards go to early career investigators. Ive mentored residents and fellows for a long time now, so theres overlap with my day job. Im also a first-generation college student, and were passionately committed to supporting that group as well.

2. Fewer than 15% of cardiologists are women. How are you closing the gender gap?

Harrington:I was raised by a single mother. I have one sister, I have a wife, I have four daughters. Im surrounded by women. And yet cardiology as a field is not known for being women-friendly.

So, I decided that I was going to make it part of my AHA presidency. We now have a lot of initiatives to address this: Weve created a new group calledResearch Goes Red, which builds on our Go Red for Women campaign, which is focused on understanding heart disease in women. Weve also created a womens research working group designed to make sure that were reviewing submitted grants in a gender-equitable way, and that were including more women as part of all of our science committees. Right now, our committees are roughly 42% women, and weve made a public commitment to get to 50% in the next few years.

And in 2019, we made the official decision to stop hosting manels, which are scientific panels comprised solely of men. When we were planning the 2019 scientific sessions, I told colleagues that I will no longer serve on a panel that only contains men, and I asked them to stop hosting panels at the AHA scientific sessions that only include men.

3. Youre involved in theApple Heart Study, which saw record participant enrollment and the widespread introduction of digital technology into clinical research. What in your opinion makes this study so groundbreaking? What have been some takeaways?

Harrington:All credit for Apple Heart goes to others toMintu Turakhia,Marco Perez,Ken Mahaffey,Manisha Desaiand their teams. My role has been supportive.

Here are the real takeaways for me: Apple Heart was intended to be a technical feasibility study: Might the watch be able to detect atrial fibrillation using the sensors in the watch and algorithms? Because its not actually detecting a-fib; its detecting an irregularity that has a probability of being a-fib based on a variety of characteristics. And I think the group achieved that.

The second takeaway, and to me the most interesting part of the study, is that in only eight months we convinced 400,000 people to give us informed consent to collect their health data. Thats the power of the technology. If we can engage almost a half-million people in research the way we did the Apple Heart Study, that could change the paradigm of how we do research. These are extraordinary tools that can allow us to have reach into numbers that we just cant do in conventional research.

4. Studies like this make it clear: Technology in research is here to stay. How can we use it in ways that are more supportive and democratic, and less intrusive?

Harrington:The biggest thing that Ive been talking about recently is how do we use the watch, the phone and the web to collect data that can be used for research purposes. And if you dont have to go to the doctors office and see your clinicians or the study coordinators, wouldnt that help to democratize research so that research could reach more people?

Right now, to be involved in research youve got to be willing to come to campus or go to a clinic. What if we could do a lot of it remotely? Might we be able to engage a group of people thats more representative of the population? That to me would be a really important step.

5. Youre very active on social media particularly Twitter. What appeals to you about this platform?

Harrington:Im a big consumer of information. And I largely use Twitter as my social media conduit. I use it to engage in conversations about things I find interesting in cardiovascular medicine, and to keep up with whats going on in the field. I now track all of my academic journals through Twitter thats how I stay current.

I really enjoy the conversations around science, and Twitter makes me read things I might not otherwise read in journals that I havent subscribed to. I think that the crowdsourcing of ideas is really helpful and informative people throw stuff out and ask what you think about it. And all of the sudden you have 50, 100, 200 different voices weighing in.

Twitter democratizes medicine you dont have to be a professor to have an opinion. In fact, some of our early-career investigators are much more facile than established professors on Twitter. Now when I travel around the country to different places for conferences and meetings, I always meet some young person I know from Twitter. Ive met new people, made new friendships and encountered new ideas.

I just tell people to decide how they want to use it. I use it professionally, and there are a few things I do regularly that people know about. For example, Im always showing pictures of my socks, particularly during heart month. I wear a lot of red socks! And everyone knows I love the Boston Red Sox because I tweet about them.

In a new 1:2:1 podcast, Harrington discusses the latest advances in cardiovascular medicine, as well as efforts to address gender inequities in the field of cardiology, with Paul Costello, the School of Medicine's senior communications strategist and adviser.

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5 Questions: Robert Harrington on research, health equity and the gender gap in cardiology - Stanford Medical Center Report

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