Population

During the first stage (first two rounds of interviews) five focus groups and 36 individual interviews were performed. In the second stage (round three), five focus groups and 21 individual interviews were performed.

A total of 136 individuals participated in the study: 85 (62.5%) women and 51 (37.5%) men; median age was 26 (range 1944) years for women and 29 (range, 1959) years for men; 77 (56.6%) participants had completed secondary school (Table1). Approximately 5% refused to participate in the study mostly citing personal reasons and lack of time.

The result sections are organized to highlight issues in contraception, ZIKV infection and PAC services, respectively.

Most participants knew at least one contraceptive method. The most frequently mentioned were pills, injections and implants, while less frequently mentioned methods were intrauterine devices (IUD), male condoms and surgical sterilisation. Both female and male participants knew about female condoms but lacked detailed information about them. Both men and women said that although they knew they could choose different contraceptive methods, they would like to receive more detailed information on each individual method, specifically regarding their adverse effects and efficacy.

They dont provide advice regarding family planning and they only ask What kind of family planning do you want? without informing the patient about the side effects of the different methods, for example the risks that an IUD can bring in the future, or the risks of the injection, so I end up choosing the method that a friend recommended. (Focus Group, women, Hospital).

Participants generally had a positive attitude towards the use of contraceptive methods. Women and their partners said they did not feel stigmatized for seeking information on methods at the health facilities. Few men acknowledged they did not allow their partners to use contraceptive methods, while others considered contraceptive use should be a shared decision. Despite the knowledge about contraceptive methods and the positive attitude, many participants specified that their children had not been planned. In fact, many women said that they had sought contraceptive methods only after giving birth.

Many participants shared doubts about the effectiveness and the adverse effects associated with contraceptive methods and had concerns on the lack of comfort when using them. Most participants believed that the effectiveness of each contraception method varied with each person. In fact, women thought that although physicians had information on the methods, they may not know how individual womens bodies would react to each method. Many participants provided anecdotes involving the experience of friends or family that supported their perception that any method, even surgical sterilisation, could fail.

This guy had sex with a lady, and she got pregnant, and he said it was not his baby . And then there was a fight at home. When he came to the hospital he got examined and he really was fertile even though he had been operated! Could you just imagine if he had killed that woman! (Focus Group, Women, Clinic).

Women most commonly accepted and used hormonal contraception; indeed, many preferred the three-month injection because it was freely distributed at the public hospital and was easily accessed. Participants main concerns regarding hormonal methods were their efficacy and their association with cancer, infertility, weight gain and skin blotches.

I am scared of implanon [implant], Im honest. No doctor will tell you the truth, they tell you the implanon will cover this or that, but they wont tell you that in the future it will give you cancer. (Focus Group, Women, Clinic).

Pills though had a burdensome daily regimen, were considered a very effective method. Participants had information on morning-after pills but explained that the use of this method was frequently associated with rape. For men, the most popular method were male condoms; however, they would use it for the prevention of sexual transmitted diseases (STI) rather than for contraception. Of note, only a few participants included Zika in the group of diseases that could be prevented through condom. Some male participants were aware of surgical sterilisation (vasectomy), although only very few men were considering having it.

Participants observed that opening hours at health centres were limited and that the distance between their homes and the health facilities was a significant access barrier. Therefore, participants often arrived at the hospital at 4am to secure an appointment. Most of the participants said that the admission process was disorganized and difficult and that waiting times were very long and thought the probable cause of delays was insufficient numbers of staff and lack of administrative organization.

Look, I came here on Sunday, at 9 am and they told me I had to come back at 1pm. I came back at 1pm and they told me they were not open because they were going to disinfect the place. So, I came back on Monday and told me to stay on a line of people, I tried to explain to the girl, so they told me to return in the afternoon. (Interview, Woman, Clinic).

Regarding infrastructure, some participants complained that the toilets were not clean; however, at the last round of survey, a few participants acknowledged there had been some improvements in cleanliness and infrastructure.

Participants considered that counselling services on reproductive health, especially on contraception were inconsistent and insufficient. Those who wanted to use contraception, received information provided at compulsory meetings only. Several participants suggested that health professionals should proactively approach people and give them more information on reproductive health and that counselling service should be extended to all even during the afternoons and evenings.

The service here (public health centre) is not the same as in a private clinic where you have to pay because here there are so many people. The doctors have to see so many people that they cannot have a special relationship with you (Focus Group, Women, Clinic).

Some women felt uncomfortable during the consultations due to lack of privacy. They would prefer female providers.

I dont know why, but with women we have more confidence, though some men are more sensitive sometimes, but for intimacy issues it is better to have a woman [as health personnel]. (Focus Group, Women, Hospital).

Often, single women sought counselling service and information in clinics outside their communities to avoid the embarrassment of being recognised by neighbours or healthcare staff. Moreover, it was reported that, sometimes, confidentiality was ignored by health staff, and this contributed to users mistrust in the services.

You know what Id change? Id make this office private for women who come here for the (DMPA) shot, because you have to pull down your trousers, and you really feel embarrassed, sometimes in presence of three, four, five other people there (Focus Group, Women, Clinic).

Participants stated that they could receive some contraception methods free of charge, including three-month injection, condoms and IUD. However, participants perceived that the condoms freely distributed at health facilities were small and of bad quality; therefore, when needed, they preferred buying at the pharmacies. Those condoms were considered to be inexpensive, of better quality and accessible in nearby vicinity. No improvement in services were perceived by the participants throughout the interview rounds.

Participants were aware that Zika was mainly transmitted by mosquitoes. Participants mentioned that pregnant women could be infected if they had sexual intercourse with an infected person and that this could be avoided using condoms.

I know that (Zika) is transmitted by the mosquito, that is the main thing, and that we have to pay attention if we have the basins, if we have plants and barrels, we have to keep them clean to avoid larvae and mosquitos at our houses (Focus Group, Women, Hospital).

However, from rounds one to three of survey, the number of participants who also knew of the possible sexual transmission of Zika, decreased (in correlation with distance in time with the outbreak).

Participants mentioned that Zika infection was associated with serious risks for pregnant women. Most mentioned that the baby could get sick, die in the womb, have problems in the head and brain; suffer from microcephaly. Fewer mentioned the Guillain-Barr syndrome and malformations. There was confusion among participants about the difference among Dengue, Chikungunya and Zika infections. For them, the three diseases had the same symptoms and consequences in men or in non-pregnant women. This perception didnt change in the different rounds of interviews.

Well, Ive heard that it affects people, pregnant women, and the baby. When someone is infected, they can infect the baby and cause complications (Focus Group, Women, Hospital).

We must be careful, if we are pregnant, we should be especially careful of not getting a bite, because the baby could be affected. (Focus Group, Women, Hospital).

Most frequently mentioned sources of information were television and radio, followed by Facebook and informative posters at health facilities. During round one of data collection, participants recalled having received information through mass or social media on how to avoid or control mosquitos at home and recalled having seen images of babies with microcephaly.

What I know is how to prevent the disease, but not how to take care of oneself once you get the disease; most of all I know about prevention, that includes a clean household and getting rid of all possible mosquito breeding places and that is what they mainly talk about in the news (Focus Group, Women, Hospital).

Health professionals were the most reliable source of information. However, at the last round of survey, at the end of epidemic, fewer participants received information or noticed any brochures or posters at the health facilities.

Information on Zika is only available when there is an outbreak, they give information to prevent the disease. Why is information available only during outbreaks? (Focus Group, Men, Hospital).

Participants mentioned that they knew of some preventive measures mostly related to the vector transmission; such as covering the water tank (called pila) and cleaning it; however, the information on the frequency of cleaning was not clearly communicated.

We should wash well the sink with chlorine, if you see a tire there with water you must empty it, if you have a leak, or containers full of water they have to be emptied, because that is where the mosquito comes from, wash all the ditches, everything has to be cleaned as much as possible (Focus Group, Women, Hospital).

They knew to use repellents, mosquito nets and coils, and cut tall grass and bushes. Less frequent practiced methods were covering buckets, cleaning gutters, or using a fan to repel mosquitos. Aside from the measures they knew of, participants explained they cleaned their house, and used larvicide and bleach in water tanks. However, many participants were against burning mosquito-repelling incense indoors because the smoke caused cough. Of note, by the third round of interviews, participants stressed that actions performed by public and technical teams in the prevention of Zika in neighbourhoods had ceased.

Upon suspicion of Zika, few participants sought care at a health centre and were referred to a hospital to confirm the diagnosis. However, not everyone attended a health centre; some were diagnosed by a relative who knew of the disease and its symptoms. Moreover, these patients acknowledge they were self-medicated with acetaminophen and liquids, because they knew how physicians treated other cases of Zika infection.

The process for women receiving PAC services at the Gynaecology and Obstetrics Emergency Room at the hospital is described in Fig.2.

Trajectory of women treated for post abortion care at the Gynaecology and Obstetrics Emergency Room and areas for improvement, Hospital, Tegucigalpa, Honduras, 2018

Women seek emergency obstetric care because either they are referred by a health centre or hospital to manage symptoms such as bleeding or pain; or because they are following up treatment with the drug misoprostol (A). Someone (partner, relative, etc.) may or may not accompany them to hospital (B). Those accompanying the women are not allowed inside the premises of the hospital. At the entrance of emergency gate, women are searched by security personnel and then escorted to a waiting area; those who are not ambulatory are assisted by hospital assistants in wheelchairs. In the waiting area, medical students interview the patients and refer them to specific services. Women needing PAC services are admitted to the Gynaecology and Obstetrics Emergency Room (C). Women in emergency are attended round the clock and those with suspected pregnancy are offered pregnancy test (rapid test).

Physicians register patients data and this registry is completed and collected daily by the statistics department. Misoprostol is prescribed and ultrasound is performed on all women. Patients under observation receive family planning counselling in the same room.

Women when referred, are warned that reaching hospital could take them up to two hours, or even more if transportation was unavailable. Participants complained that no other public hospitals offered PAC and highlighted the need for these services to be closer to their homes.

I decided to come today because I was bleeding so much, I fainted, had cold sweats, nausea and my body was shaking (Interview, Woman with MVA procedure, Hospital).

Women had to cover the transportation cost to the only hospital that offered PAC services in the city, and had to pay 200 Lempiras (approx. US$8) per treatment. However, it could reduce to 50 Lempiras (approx. US$2) if social services office certified that the patient could not afford the full fee. Moreover, the hospital also required the patients to bring a gallon of water to clean the medical equipment.

Some patients had to pay for their medication and most women paid for a rapid pregnancy test. It was mentioned that misoprostol, anti-inflammatory agents and analgesics were not freely available; instead, patients had to buy them out-of-pocket. Many times, these payments for specific treatments were out of reach of patients.

They asked me to buy a pregnancy test. Afterwards when they were about to perform the MVA they told me that I had to pay 200 Lempiras and purchase a container of water. (Interview, Woman, Hospital).

By the final round of this survey, following discussion of research team with health authorities, this requirement and the fee was eliminated. The hospital administration purchased a water filter system for emergency room and medical staff with research studys funds.

Participants complained that male partners and relatives were not allowed into the hospital and had to wait long hours without any protection from the weather; slept on the floor at night and received no updates on the health of their partners from physicians or nurses.

The cleaners just started to throw water on the floor, they didnt mind if I had my clothes there or if I was sitting there. I was sitting there, after two nights without any sleep, I fell asleep on my bags on the floor and when I woke up because someone told me to, they were throwing water at me (Interview, Man, Hospital).

Women seeking for emergency care remained unaccompanied in the waiting area and during the procedure.

Through emergency, I got her [wife] in and the guard treated me badly because I came with her and he told me that I couldnt go in and I told him that it was an emergency because she was my wife and she was really sick and had problems. (Focus Group, Men, Hospital).

A very common complaint during the first round was the lack of privacy for the women who sought assistance or during a procedure, including the lack of sufficient beds or rooms. Most participants complained that the admission process was disorganised, difficult and time-consuming, the public toilets were unclean, and medications were often lacking.

The reproductive health counselling was only given after MVA procedures were performed, with no privacy and in the presence of other patients. Over time, participants acknowledged some improvements specially ward cleanliness.

Many participants agreed they had been mistreated by physicians and nurses when seeking PAC or emergency care. Some of the women felt that they were laughed at, reprimanded and ignored by both physicians and nurses.

Today, I was undergoing the MVA, the doctor was doing the procedure with people standing by the door, there was a student asking one thing and another and doctors phone kept ringing. (Interview, Woman, Hospital).

The most common complaint was the staffs lack of empathy and indifference to their health situation.

My mom asked for information because when I was in the ward and there were many girls who had had an abortion and they told me you have to rest, you cant crouch, you cant travel. So, I told mom to get information. The first time I had an abortion, they didnt explain anything to me, they just told me go away and take care!, just that. So, my mom asked a nurse and she just said I had to rest, just that (Focus Group, Women, Hospital).

Accompanying male partners and female patients described instances of mistreatment by the security staff when being admitted to the hospital. The male partners mentioned that they did not receive information about the patients health and procedures during in-hospital stay, the remarked they feel mistreated and that produced distress and fear.

My partner was being accompanied by her sister. I could not get in touch with my partner, I could not even call her on the cell phone. Then, I could talk to her sister, she called me, she was crying and told me that my babys heart was not beating and the doctors had performed an ultrasound and had seen my baby was dead and that they going to do another ultrasound (Interview, Man, Hospital).

Some women complained of having to wait for long hours in pain, only to receive what they perceived as unsatisfactory care. Some women who were prescribed misoprostol felt that they had been discharged without adequate information as they felt staff did not sufficiently explain the procedures to them. Some patients reported that physicians did not treat and even ignored the symptoms they complained about, in particular, pain. After unsuccessful treatment in their own home, some participants had to return to hospital for treatment.

It is a horrible sensation, because one feels as if they are pulling the uterus and the doctors only tell us to cooperate but that is, it is impossible to stay relaxed, when one is going through something so painful. (Interview, Woman, Hospital).

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Contraception and post abortion services: qualitative analysis of users' perspectives and experiences following Zika epidemic in Honduras - BMC Blogs...

Recommendation and review posted by Bethany Smith

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September 01, 2020

When Christina Sarcevic Verdgeline, of Forty Fort, picks up her camera, the result could be a closeup of stunning dark pink foxgloves, a brilliant yellow sunflower or maybe a picture of an insect doing what an insects gotta do. More about that later.

If she picks up a pencil, she might draw a detailed sketch of a young woman in a high-collared Croatian dress. Or of a solitary cross on top of a mountain overlooking the village of Medjugorje in Bosnia-Herzegovina.

With a repertoire that ranges from pointillism to architectural renderings, the multi-talented Verdgeline, 60, has sold a miniature acrylic painting called Starry Lake, reminiscent of Vincent Van Goghs Starry Night, that was on display at Mainstreet Galleries in Kingston, and collected a third-place prize from the Wyoming Valley Art League for a snowy watercolor called Winter Tracks.

While one of her next projects might be a sketch of the historic Denison House, located not far from her home, Verdgeline admitted that in recent months she hasnt had an abundance of time for painting or sketching. Not with working full time at a bank in Scranton and, quite frankly, feeling the pull of a garden and yard that called out to her like a blank canvas.

This is the first full summer she and her husband, Paul, have spent at their new home in Forty Fort after moving from Plains Township, and Verdgeline has taken great joy in planting daisies and lilies, zinnias and black-eyed Susans, coreopsis and cone flowers.

Beautifying the yard is an art, too, she said.

Art is something you see with your eyes, but it speaks to your heart, said Verdgeline, whose heart seems to dance with joy whenever she notices a bumblebee visiting a zinnia, a butterfly hovering near the butterfly bush that survived the move, or a goldfinch attracted to the sunflowers.

Yay! I had my first monarch butterfly sighting in our backyard, she gleefully reported in July.

Of course, nature isnt always pretty.

Some people might think its kind of creepy she said of the photograph she shot of a praying mantis devouring a bumblebee, an image that was exhibited at Wilkes-Barres Fine Arts Fiesta and also accepted into an international National Geographic photo contest. But thats nature. Its the circle of life.

Verdgeline said she hadnt noticed the praying mantis at first, when she started shooting photos of asters. Then a bee came along and ate a little from one flower. Then suddenly the mantis was there and just grabbed the bee.

Fascinated, the artist said, I thought about it and realized this is a moment in both these creatures lives that will never happen again.

While Verdgeline has created hundreds of pieces of art (which she sells as prints, stationery, apparel and more, through christina-verdgeline.pixels.com) her favorite is a miniature painting, which was exhibited at Luzerne County Community Colleges Schulman Gallery in 2015, called Cranes in Croatia.

Her inspiration for the painting of the birds, in their nest on top of a chimney, was a photo her niece, attorney Adriana Vukmanic, shot on a trip to Croatia, in an area not far from where Verdgelines father grew up.

The artists parents, Joseph and Helen Sarcevic, fled the former Yugoslavia on foot in the late 1950s, making their way across the border into Slovenia first and then into Italy.

My parents were in their 20s at the time, Verdgeline said, recounting the family story about the way Joseph and Helen crossed the first border by mingling with a group of students who were heading into the woods for a picnic and didnt return with them.

The Sarcevics had arranged to meet and travel with another couple, but the other couple never showed up at the meeting spot. Verdgelines parents crossed the second border at night, hoping and praying the border guards would not notice them under the light of the full moon.

They were praying like crazy, Verdgeline said her mother told her. Even today, I get chills just thinking about it.

Years later, Verdgeline would have several opportunities to visit her parents homeland with them, and to visit relatives.

In 1983 her mother wanted to take a side trip to the village of Medjugorje in Bosnia-Herzegovina, where several teen-agers and a younger boy claimed to see apparitions of the Blessed Mother.

The artist was 23 at the time and wasnt especially eager to go there, Verdgeline recalls. My sister and I were, like, oh, Mom

But they accompanied their mother and were able to spend time in the same room with the visionaries.

I felt the highest high I ever felt in my life, the artist recalled. I felt as if I was part of everything, at one with everything and everybody.

Verdgelines mother eventually led pilgrimages from America to Medjugorje through an organization called Mir Peace and Verdgeline found inspiration there for yet another style of artwork, including Christmas cards, Easter cards and greeting cards featuring messages from Medjugorje.

The artists sister Darlene Milas of Clarks Summit has led the groups most recent pilgrimages to Medjugorje, but not this year becaue of the global pandemic.

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The day after I was diagnosed with breast cancer, I walked into the garden center of the nearest home improvement store. My mission: Bring home the prettiest rose on the lot.

My garden is my sanctuary and plant stores are my happy place verdant showrooms overgrown with aspirational beauty. Under normal circumstances, I can spend hours wandering blithely, smelling flowers, indulging daydreams.

That day was different. I wandered up and down the aisles in a daze, an uneasy feeling burrowing under the breast that betrayed me, an ugly squatter setting up residence in my chest.

Then I saw her the Miranda Lambert rose. This was no ordinary rose. Impossibly large and pink with petals spilling forth from the center, this was a fairy princess petticoat of a flower, a Southern belle on the way to her Sweet 16, a rose that exuded sassy femininity like its namesake country crooner.

For a moment, as I imagined her blossoming in my front garden, the fear and worry dissipated. I felt at peace.

This is not a story about that rose. If youre waiting for the glorious rose bush at the end, spoiler alert: It still hasnt happened. But it is a story about the magic of plants and every time Miranda blesses me with a bloom, something magical happens inside me.

Lets be clear: I never thought I was going to die. My diagnosis was ductal carcinoma in situ (DCIS). I was classified stage 0. It was non-invasive. This wasnt hard cancer. I had done that seven years earlier when my 2-year-old daughter was diagnosed with an aggressive form of acute lymphoblastic leukemia that required a grueling two-year course of chemotherapy, most of which was in-patient.

Did you know theres a tunnel between the Specially for Children clinic building in the Mueller development and Dell Childrens Hospital? We used to check in at the Childrens Blood and Cancer Center on the top floor of the complex early in the morning, then walk through the basement tunnel to the hospital to admit for surgery (a spinal drip of chemo), usually followed by treatment stays that lasted three to 10 days. We did this over 20 times. One day we walked with a woman who had lost a daughter to bone cancer and now had a son battling leukemia. She told me she didnt like being in the basement because she had to go down there to collect her daughters remains.

I know the way cancer ravages peoples lives, and what I was facing was certainly not that.

In truth, I was lucky. I had put off getting my first mammogram for a couple of years and only forced myself to do it when my company changed ownership, triggering a change in my health insurance. While the cancer was unable to spread beyond the milk duct where it was discovered, the cells were dividing rapidly so fast you could see it happening under a microscope, one doctor told me.

It was April, that brief season when Texas is blissfully temperate and exploding with natural beauty. Id taken to working out my emotional issues in my garden a few years earlier, after my husband and I completed a remodel of the East Austin home we had owned for a decade. Piece by piece I reclaimed the front yard from strangling Bermuda grass and weeds. In the winter I laid down slabs of cardboard and brown paper bags, then covered them with mulch, and now I had the final section, one of my only sunny patches, ready to plant. Thats where I put my girl, Miranda.

My treatment plan was not difficult. There would be surgery, a lumpectomy and reduction my plastic surgeon called it a "lift" and my girlfriends and I decided to go with that because it sounded like something fancy ladies do after brunch followed by 21 rounds of radiation and no chemotherapy.

Physically, I knew I could handle it. I had delivered two babies, one by emergency C-section. But something strange was happening with my mental state. So much of my job is forward-facing and suddenly I didnt want to be seen. I wanted to disappear, to hide in the shadows.

A few weeks before the surgery, I hosted a Facebook live session in the Statesman studio with Black Pumas, a band I love that was about to be famous. Theyre the nicest guys in the world and it was an easy interview, but I felt stupid and awkward. Afterward, the producer said I seemed nervous.

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The only thing that put me at ease was working in my garden, which I did at a fevered pace, knowing that I might not be able to dig in the ground after the surgery. My mom bought me a golden thryallis, which I made a centerpiece of the bed at the front of my yard, and my uncle sent me two dwarf fruit trees, a goji berry and the adorably named Little Miss Figgy. In one of my few sunny corners at the edge of my yard I planted the most symbolic addition, an esperanza, a shrubby perennial with beautiful clusters of yellow trumpet flowers and a name synonymous with hope.

Cancer changes the way you think about your body, breast cancer maybe doubly so. As women were constantly judged by our appearance and this society is obsessed with breasts. Id been busty since I was 11. My adolescence was defined by fending off unwanted touch and fighting to be known for my mind, not my body. In my 20s, surrounded by a badass group of sex-positive hip-hop chicas, I learned that it was possible, powerful even, to be known for both.

"I dont want to lose my titties," I told my husband, tears welling in my eyes.

"I dont want to lose you," he said.

And he held me tight.

Again, I was lucky. When the post-op lab results arrived, my margins were clear. No further surgery was required. I was part of a Facebook group for women my age and younger facing breast cancer, and I was in awe of the strength and dignity of these women some with tiny babies, some factoring the children they might one day have into difficult treatment decisions, some facing unfathomable challenges with incredible grace.

Still, I felt like a shell of myself. Who was this person who had been sliced apart and Frankensteined back together? For four long weeks, I had a daily date with a gamma ray machine and no promise of superpowers. My confidence was shaken. At work, I was faking it, fumbling my way through.

But the esperanza began producing cheery yellow flowers, alongside the fiery blooms of the huge pride of Barbados at the front of my yard that was gifted to my family years earlier when my daughter fell ill.

A pair of massive pecan trees blanket my yard in almost full canopy shade, and for several years I had obsessively searched the garden sections of discount stores like Ross and Marshalls for interesting, affordable containers to place around their bases. Now, unable to dig in the ground, I doubled down on these efforts, painstakingly arranging pots in colorful collections that made me smile.

A few months out, when the pain from the surgery subsided enough for me to work with my arms, I bought a set of drill bits that cut through porcelain. Soon I was combing the kitchen sections of thrift stores, in search of interesting mugs and bowls that could be repurposed as whimsical planters.

No stranger to rooting plants in water, I began diving deeper into the art of propagation. I bought rooting hormone and began taking cuttings of everything around me and sticking them in small pots filled with dirt that lined my front steps. It was my private laboratory. Sometimes the stalks withered and died immediately, but sometimes they flopped over, looking sad but still green for a week or so, then miraculously pulled themselves up as new little plants.

Obviously, a true botanist could explain the scientific process behind how this happens, but I didnt care about any of that. To me, this was pure magic and the fact that I was secretly becoming an amateur plant wizard was rebuilding my morale. If I could dig in the dirt and create life and beauty with my bare hands, who knew what else was possible?

In October, as the oppressive grip of summer loosened, I realized I was starting to feel like myself again. For the first time in my life, I decided to plant annuals. I had never understood why people would waste time putting something in the ground that they knew would die a couple of months later, but that winter, as pansies and snapdragons adorned my garden with dazzling bursts of color, I got it. Ephemeral beauty is magical, too.

RELATED: Parking lot birding unlocks nature where you are

Since the country shut down in March, Ive been relishing the comfort of my garden. Spring was spectacular and even in the dead of summer, the thryallis is blanketed with tiny yellow flowers and the esperanza and pride of Barbados are blooming brightly. After dark, heady perfume from night-blooming jasmine drifts up to my balcony, adding an air of enchantment to my outdoor lounge.

Desperate to add to my container collection, I went foraging in a neighbors backyard and found a few rusty tin buckets. I drilled holes in them and filled them with flowers. Ive doubled down on my propagation lab and now angel wing begonias with deep green and burgundy leaves and sprays of delicate pink flowers are scattered around my garden alongside heat-hardy kalanchoes.

This year, I moved Miranda to my backyard, where she doesnt have to compete as much for the small patch of dappled sun I can offer her. And like she has for each of the last two years, she provided me with just a handful of beautiful, decadent roses. Do I wish shed bloom abundantly? Of course. But Ill take what I get. Every time I see one of those extravagant flowers my heart sings.

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Grounded: A story about breast cancer and the magic of plants - austin360

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Infertility is a global issue with one in five couples worldwide struggling to conceive. In Ireland that figure is thought to be one in four. When infertility occurs it can be a very painful experience for women or couples that really want a child.

Globally, couples are waiting longer to start a family, which has meant a steady rise in infertility rates. According to experts, every year, the number of people accessing assisted reproductive treatments increases by 5- 10 per cent. In addition to heterosexual couples, there are same-sex couples and single women who need fertility services to create their families.

In 30 per cent of couples the cause is attributed to male factor infertility, 30 per cent are female factors, 30 per cent will have a combination of male and female factors and in 10 per cent of cases no cause will be found, which is called unexplained infertility.

Dr Bart Kuczera, of Beacon Care Fertility, says roughly 2 per cent of women in the 20-44 age bracket will be infertile if they never use contraception, or have never delivered a baby. Of those who have had one child and wish to have another, the figure for secondary infertility will be about 10 per cent for the same age group.

The scale of the problem is significant, Dr John Waterstone, of Waterstone Clinic in Cork, says. In the Western world, women are steadily waiting later in life to become mothers. According to Eurostat figures, 52 per cent of first-time mothers in Ireland are between 30 and 39. Alongside Italians, Irish women are the oldest mothers in Europe, he says.

This trend looks set to continue, and we know that age will limit womens ability to conceive. The rates may be complicated further by a drop in male fertility as studies are showing that sperm counts are falling in men in Western countries, he adds.

The older a woman is, the more her egg quantity decreases, while the chance of miscarriage unfortunately increases, group head of nursing at Sims IVF and Rotunda Deirdre Gorman says.

Those suffering from PCOS (polycystic ovarian syndrome) and endometriosis can also play a huge part in female infertility. Male factor infertility is also a major factor. Lifestyle choices such as smoking and drinking can affect sperm quality too.

For those that are experiencing problems conceiving, the rule of thumb is: under the age of 35 and trying to conceive for a year or more, get tested. Those over 35 and trying for six months with no luck should see a doctor. The good news is there are now lots of options available to help women get pregnant.

In heterosexual relationships there is timed sexual intercourse and artificial insemination that can be beneficial for younger women.

We have IVF or ICSI, which is a more sophisticated version of IVF. One single sperm is selected to fertilise the egg. If egg or sperm quality is the issue then we have donor programmes available. PGS is another procedure, whereby after the embryos have been created they can be tested for any abnormalities. This is especially useful for those experiencing recurrent miscarriage, Gorman says.

If you are a single woman, we have a robust sperm donor programme, artificial insemination or IVF would be options too. Same-sex female couples will need sperm donors but we also have a fantastic programme called Shared Motherhood Reciprocal Donation, she adds.

This is where the eggs of one partner are used in an IVF cycle to create embryos that are then transferred into the other partner, with the effect that one partner is the birth mother and the other partner is the genetic mother.

Meanwhile, periodic sexual and fertility health checks for both men and women will let them know where they stand in terms of fertility and can help them plan for the future.

During a fertility check , we use blood tests to explore various hormone levels, one of which is the anti-mullerian hormone (AMH) level. Along with your menstrual history and a transvaginal ultrasound, we count the number of antral follicles in the ovaries and explore the general health of your uterus and pelvis. These explorations help us to build a picture of your overall fertility health and give an insight into your ovarian reserve. At the end of the check, youll know if you have more or fewer eggs than average for someone of your age, and have our recommendations. You can then use the results to inform your decision making, Dr Waterstone says.

After a fertility test, women might consider preserving their fertility through egg freezing, or pursuing fertility treatment with a partner or donor. IVF remains the most common treatment plan for women who cannot conceive, with 80 per cent in Sims IVF and Rotunda undergoing the treatment.

However, simple procedures are tried first the philosophy at Waterstone Clinic is to minimise intervention while maximising patients chances of creating a family. They often use ovulation induction (OII) treatment or intrauterine insemination (IUI) treatment first.

So what happens during IVF? A woman produces many immature eggs each month. One or two mature eggs become dominant and the rest are then discarded. In fertility treatment, we use drugs to stimulate those immature eggs and help them mature. The woman will have to undergo a series of injections and undergo ultrasound scans to see how the eggs are developing. This usually takes 10-14 days. After this, she will undergo an egg collection. Her eggs will then be fertilised in the lab by her partners or donors sperm. The embryos are then usually grown out to five days. Either they will be frozen or transferred after those five days, Gorman says.

There is also the option of freezing embryos when exploring IVF. This means it is possible to have one round of IVF treatment and create an entire family from that one cycle over the course of a few years.

Sims IVF and Rotunda'smost recent clinical pregnancy rates sees 48.7 per cent under 35, 49.8 per cent between 35 and 37, 41.8 per cent between 38 and 39 and 30.6 per cent for women 40 getting pregnant and a foetal heartbeat is found at a scan between 8-12 weeks gestation.

At Waterstone Clinic, for women aged between 38 and 39 they have a live birth rate of 30 per cent (meaning a baby born full term) while women aged between 40 and 42 can expect a live birth rate of 22 per cent.

While each cycle of IVF is expensive, ranging anywhere from 4,500 to 8,500 with an average cost of about 6,000 there is also a physical and psychological cost too.

Physically it is well managed, but psychologically the toll is much higher. For patients who have had two failed cycles, this can be similar to a loss in your family. This is a degree of stress that often involves counselling and its one of the reasons why they have a link with professional counsellors if they are struggling and this is a part of the patients management, Dr Kuczera says.

Fertility doesnt last forever, and at some point infertility is natural every couple will be infertile eventually, so the sooner you start diagnostics the better the outcome, he adds.

Continued here:
Fertility treatments on the rise as couples waiting longer to start families - The Irish Times

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During pregnancy, there are several ingredients in skincare and beauty products that are not recommended for use. Since some ingredients are chemical-based and doctors advise that their use be discontinued during pregnancy. Other components that might seem natural, such as pure essential oils, should also be used with extreme caution due to the fact that there is not enough research to support their safety. Furthermore, beauty skin treatments like skin peels and Botox should definitely be put on hold during pregnancy. While the ingredients are not safe, there are also slight risks of your body going into a minor state of shock due to the pain of the procedure (similar to why women are not meant to get tattoos during pregnancy). While the risks might be low, it's better to take no chances with an unborn baby's health!

While it might seem daunting to uncover which products are the safest to use during pregnancy, BabyGaga has consulted industry experts to get the scoop on which ingredients should be completely avoided during your pregnancy. It's always recommended that you do a bit of a spring clean in your beauty and cosmetics collection once you are expecting since many products won't keep until after the baby is born. Consider it a great opportunity to get closer to nature, and to eliminate some of the harsher ingredients in your day to day products.

RELATED:Ingredients To Avoid In Melasma Treatments

The biggest rule of thumb in pregnancy skincare is to avoid all products with retinol as an ingredient. Retinol is derived from Vitamin A and has been clinically proven to have adverse effects on babies in utero. While not all women will have complications from using products with retinol, it's strongly suggested to avoid it entirely until after the baby is born. There are so many alternative products in the skincare world these days that have natural ingredients, and experts agree you should stick to these!

Dr. Yelena Deshko ND is a naturopathic doctor who runs the Timeless Health Clinic of Integrative Medicine in Toronto, Ontario. As an expert in skincare procedures, she has years of experience using various skincare products on her clients. Dr. Deshko spoke to BabyGaga about the risks of using retinol during pregnancy:

The number one ingredient that pregnant women need to avoid in their skincare is retinol. Retinol is a derivative of Vitamin A and has been shown in scientific studies to have a teratogenic (negative) effect on the developing fetus. In addition to this, it is generally prudent to switch to mainly natural and organic skincare products. Skin is our largest organ and many chemicals found in commercial products are easily absorbed through the skin. The effect of many of these ingredients has generally not been evaluated to be safe for the developing baby and they may present certain risks.

While retinol is one of the most harmful ingredients in skincare products for pregnant women, there are several other ingredients and components you will want to skip. BabyGaga spoke withDr. Kemunto Mokaya (Dr. Kemmy MD), who is a board-certified dermatologist, author, and speaker who hails from Knoxville, TN. As a skincare expert, she was able to give us a more comprehensive list of what ingredients pregnant women should watch out for in makeup and skincare. Dr. Mokaya advised against using,

Retinoids: The first product that comes to my mind is retinoids. They are vitamin A derivatives that are popular skincare products because they help control acne, they help even out the skins pigmentation and are anti-aging products that stimulate collagen growth (thereby reducing fine lines and wrinkles). They are not recommended in pregnancy because they are associated with birth defects. Oral retinoids are actually pregnancy category X (meaning that studies in humans and animals have shown them to actually cause harm to fetuses, including fetal abnormalities). Topical retinoids are pregnancy category C.

Hydroquinone: It is tempting to use hydroquinone a skin lightener during pregnancy to treat melasma and other pigmentary defects of pregnancy. However, its use in pregnancy should be avoided, especially because studies have shown that as much as 45% of hydroquinone is absorbed into the skin after topical application. The FDA lists hydroquinone under pregnancy category C and its use should be avoided until after the baby is born.

Botulimum toxin (e.g. Botox or Dysport): *Use of botulinum toxin to paralyze muscles around wrinkles, thereby making the wrinkles less visible, is one of the most popular non-invasive cosmetic procedures performed. It is not recommended or FDA-approved for pregnant or lactating mothers.

Benzoyl peroxide & Salicylic acid:Benzoyl peroxide and salicylic acid are medications commonly used to treat acne. Pregnancy can cause hormonal acne, and while it is tempting to use them to control the condition, they are classified by the FDA as pregnancy category C. They should therefore be avoided in pregnancy.

Formaldehyde: Formaldehyde is a carcinogen that has also been linked to fertility problems and miscarriages. It is found in some hair products (e.g. hair straighteners), nail polishes and eye-lash glue. Formaldehyde should be avoided in pregnancy.

Essential Oils: Should be used with caution in pregnancy. They are not regulated by the FDA and therefore do not have to follow strict labeling standards. It is difficult to assess the quality, concentration, or purity of different essential oils due to the loose regulations. Unless the source of essential oils is a verified and trusted one, it is best to simply avoid them in pregnancy. For example, tea tree oil when absorbed in high quantities can affect hormones and trigger premature contractions.

Phthalates:Some studies have found a link between phthalate exposure and abnormal development of fetuses. Personal care products containing phthalates should be avoided in pregnancy.

Dihydroxyacetone: Many spray self-tanners contain the chemical dihydroxyacetone. It is commonly listed on product labels as DHA. If it is accidentally inhaled during its application, it is unsafe for the mother and the baby.

Toluene: Many nail-polishes contain toluene, which is a suspected carcinogen. It should be avoided during pregnancy due to the potential risk to the fetus.

Chemical sunscreens: Ingredients in chemical sunscreens include: Avobenzone, homosalate, octisalate, octocrylene, oxybenzone, oxtinoxate, menthyl anthranilate and oxtocrylene. Some of these ingredients are thought to be hormone disrupters. They can interfere with the babys nervous system development.

Thioglycolic acid:Found in chemical hair removers; can also be labeled acetyl mercaptan, mercaptoacetate, mercaptoacetic acid and thiovanic acid.

If you have struggled with problem skin prior to becoming pregnant, or you are experiencing pregnancy-related skin issues, you might want to make an appointment with a dermatologist to see what the root of the problem is. A specialist can determine what is causing the issue, and recommend skincare products that are safe to use throughout pregnancy.

Furthermore, dermatologists can offer treatments or facials that do not use harsh chemicals or products and can help you relax and feel pampered!

If you are experiencing eczema or skin rashes, you can even speak to your GP or OBGYN. Many of these conditions are really common during pregnancy and can be treated with safe for use creams. In the absolute worst-case scenario, the condition will likely only last during pregnancy, and should clear up as soon as the baby arrives. While this isn't always the best news for women who haven't dealt with skin problems until pregnancy, it is generally due to hormone changes and will not last forever.

Though you might have to ditch some of your cosmetics and skincare treatments during pregnancy, it doesn't mean that your skin has to suffer. In many cases, switching to more natural ingredients can be very soothing for your skin. There are many DIY face masks that you can create with items from your fridge. For a soothing face mask, you can add plain yogurt, oatmeal, and honey. If you need more hydration, blend an avocado, an egg, and a teaspoon of honey. Some of the most basic items can be used in your skincare routine, like using coconut oil as a moisturizer, for example.

With a multitude of vegan, organic, and natural cosmetic lines on the market today, you should have no problems finding some new makeup items to get you through pregnancy without issues. It's also a great time to skip makeup altogether, and give your skin a breather! While it might take a little time to adjust to bare-faced, you might notice that after skipping makeup for awhile (or reducing the amount that you wear) your skin will actually look and feel more healthy.

Skin health is super important during pregnancy since your skin absorbs everything that you put on it. You will want to be extra vigilant during these months to make sure that you are not lathering yourself up with toxic and harmful ingredients.

If you are an essential oil enthusiast and you chose to continue using them, exercise caution and dilute them with a carrier oil to make sure you aren't putting a highly concentrated oil directly on your skin. Make sure that the source of your oils is reputable, and do a little bit of a background check to find out which oils are potentially dangerous for pregnant women and fetuses.

Getting a good amount of sleep and drinking enough water can help keep skin issues at bay, so make sure that you are monitoring this during your pregnancy! Dehydrated skin is more prone to breakouts and rashes, so make sure your skin is drinking enough!

NEXT:How To Treat Postpartum Dry Skin

SOURCES: Timeless Health Clinic, Dr. Kemmy, MD, Women's Health Magazine

This Is When Chelsea Houska Will Give Birth

Ariane Signer has been writing her thoughts, fears and dreams in journals since the early 90's. A personal development and self-help junkie, she has been working as a creative freelance writer since 2016. A native Canadian, she has found her home in small town Switzerland, where she lives with her husband and two young sons. She published her first book, Things That Shine: Poems, in 2019.

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Skincare Ingredients To Avoid During Pregnancy | BabyGaga - BabyGaga

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IRVINE, Calif.--(BUSINESS WIRE)--Please replace the release issued September 10, 2020 with the following corrected version due to multiple revisions.

The updated release reads:

APPLIED BIOLOGY IN COLLABORATION WITH CORPOMETRIA INSTITUTE TO LAUNCH ANTI-ANDROGEN CLINICAL STUDY FOR THE TREATMENT OF COVID-19 (ANDROCOV TRIAL)

Breakthrough Discovery by Applied Biology Scientists Paves Way for a Generic Anti-androgen as a Treatment For COVID-19

While studying the genetics of the androgen receptor in male pattern baldness, a team of scientists discovered a possible breakthrough treatment for COVID-19.

The team led by Andy Goren, MD and John McCoy, PhD from Applied Biology along with other collaborators have published their discovery in the medical journal Dermatologic Therapy. The manuscript, What Does Androgenetic Alopecia have to do with COVID-19? An Insight into a Potential New Therapy (doi: 10.1111/dth.13365), elucidates the possible role of androgens in controlling the infectivity of SARS-CoV-2 in human lung cells.

According to Dr. Goren our earlier discovery potentially links SARS-CoV-2 infectivity to androgens, the same hormones implicated in male pattern baldness and prostate cancer.

To test their hypothesis, the team has joined efforts with renowned endocrinologist Flavio A. Cadegiani, MD, MSc, PhD. Dr. Cadegiani is the medical director of the Corpometria Institute in Brazil. Currently, Brazil is the epicenter of the COVID-19 pandemic. According to Dr. Cadegiani: I am excited to participate in the international effort to study anti-androgens in COVID-19. More information about the study (ClinicalTrials.gov Identifier: NCT04446429) is available at clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT04446429?term=NCT04446429&draw=2&rank=1)

ABOUT APPLIED BIOLOGYFounded in 2002, Applied Biology, Inc. (www.appliedbiology.com), headquartered in Irvine, California, is a biotechnology company specializing in hair and skin science. Applied Biology develops breakthrough drugs and medical devices for the treatment of androgen mediated dermatological conditions. Applied Biology's R&D pipeline includes a topically applied prophylactic treatment for chemotherapy induced alopecia; a novel diagnostic device that can aid dermatologists in identifying non-responders to topical minoxidil; an adjuvant therapy for non-responders to topical minoxidil; and a novel therapy for female pattern hair loss.

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CORRECTING and REPLACING Applied Biology in Collaboration with Corpometria Institute to Launch Anti-Androgen Clinical Study for the Treatment of...

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We are not born violent. Outside factors depict who we become. Like John Locke theorized, we are born with a blank slate. Some scientists propose that humans are innately violent. For example, David Carrier hypothesized that human hands evolved for us to be better fighters. However, there is evidence from other anthropologists, like Douglas Fry, proving that humans can make peace without resorting to violence.

Chimpanzees and bonobos are our closest relatives. Some scientists argue that humans, especially males, are inherently violent like chimpanzees. While male chimps fight for territory and females, bonobos tend to be more peaceful and share meat. Bonobos are female-dominated troops, so males may be less violent due to reduced competition for mating. It seems most violence from chimps stems from competition for limited resources. One study showed that bonobos are kind and generous to those outside of their groups. Behavior like this is not typically seen in chimps, who are aggressive to outsiders, while bonobos are usually not. Humans are more like bonobos than chimps: they want to collaborate and make peace with one another. In society today, most developed countries no longer need to fight for resources. Instead, we work together through trade and peace treaties.

The environment shapes our nature. For example, Brad Bushman and L. Huesmann studied how violence in mass media affects adults and children. They found that children will experience long-term effects of aggression because they mimic their environment. They explained that through classical conditioning, a child may then react with inappropriate fear or anger in a novel situation that is similar to one that the child has observed in the media. Adults may experience long-term effects of violence depending on their past exposure to aggression.

Viewing violence in mass media desensitizes us to it. We become less sympathetic to others and more antisocial. People are not innately violent: what we learn and observe can make us violent.

What we experience and learn makes us who we are. People become violent, angry, and fearful because of what they see in mass media and real situations. One literature review on how child abuse affects a childs behavior revealed that physically abused children have structural brain changes proving that outside factors shape our minds. Children who were abused tend to show the following signs: fighting with others, suicidal thoughts, poor grades, anxiety, depression, high probability to commit crimes such as underage drinking, drug use, etc. This means that our experiences help determine our behavior. Children who were abused may be more violent or rebellious because of their upbringing, not because they were born with a violent nature.

Some scientists also argue that genetics help determine our behavior. For example, genetics shape our personalities, and in some cases, affect our behaviors and attitudes. However, as we have different experiences over time, our personalities may change. Why? Because outside influences affect our behavior. Brent Roberts and Daniel Mroczek studied the changes in personalities from youth to adulthood. They explained that our personalities usually change as we grow older. For instance, someone who was an introverted teen may become more extroverted as they get older depending on their experiences.

In one experiment, scientists studied 3-month-old infants reactions to two different scenarios: one with a Climber trying to reach the top of a hill where a Helper pushed them up or a Hinderer pushed them down the hill, and the other control scenario with inanimate objects. Results showed that 10 out of 12 children valued the Helper while five out of 12 liked the Pusher-Upper inanimate object. The research proved that infants can interpret positive social cues and motivations, such as the Helper guiding the Climber up the hill.

The way we are raised and what we experience shapes us. We mimic our environment; if we see violence, we may become violent and reflect negative emotions.

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Opinion: Be it resolved human nature is not violent - The Appalachian Online

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What are the symptoms for prostate cancer? Heres the thing you probably wont notice any.

Prostate cancer is not symptomatic until late, so screening is important, Dr. Michelle Yu, a urologic oncology fellow at University of Pittsburgh Medical Center, told TODAY.

Symptoms of prostate cancer may include:

Yu said that by the time men notice such symptoms the cancer has likely spread to other parts of the body and will be a lot harder to treat. (Of course, some of these symptoms could be caused by other conditions.)

Cancer of the prostate develops when cells in the prostate, a gland thats important for male reproduction, grow abnormally. This type of cancer often progresses slowly.

One in nine men get it its incredibly common, said Dr. Rana McKay, an assistant clinical professor at University of California San Diego and a spokesperson for the Prostate Cancer Foundation (PCF). Because of the type of disease this is theres some stigma. We need to be raising awareness.

A lot of high-profile men have helped increase awareness of prostate cancer by coming forward with their own stories about screening, diagnosis and treatment.

Some high-profile men who've had prostate cancer include:

Trending stories,celebrity news and all the best of TODAY.

The good news? Screening is easy and effective. The most important thing is screening, McKay said.

Prostate cancer is one of those diseases where early screening and early detection improves outcomes. The PCF reports that about 95% of prostate cancers are detected before the cancer has spread outside of the prostate.

And the survival rate from prostate cancers is 99% after five years. The good news is, the majority of people diagnosed with prostate cancer dont die of their disease, given the effectiveness of treatment, McKay said.

Your doctor can help evaluate your risk and recommend the best time to start screenings.

According to the PCF, screenings generally start at:

The number one thing men can do is to ask their doctor if they are eligible to be screened, McKay said.

To screen for prostate cancer, your doctor will perform a digital rectal exam (DRE). This test involves inserting a gloved finger into your rectum to feel for any irregularities in the prostate. The test might be uncomfortable, but its brief, and its an important step toward uncovering prostate cancer early.

Your doctor will also check your blood to measure prostate specific antigen (PSA) levels. PSA levels go up when theres a problem with the prostate that problem could be prostate cancer, an infection or another condition.

What are causes of prostate cancer? Its not clear exactly. Genetics and environmental factors both play a role, McKay said. One in 10 men have a genetic predisposition for prostate cancer.

Diet, exercise and quitting smoking can help decrease your risk for developing prostate cancer. Choose a diet lower in fat and processed carbohydrates, and maintain a healthy body weight to help reduce your risk of developing more aggressive prostate cancer.

Also, some studies show that having sex frequently can lower your risk.

If your DRE shows an abnormality or your PSA has elevated numbers, your doctor will probably recommend a biopsy of the prostate and may recommend an MRI or other imaging studies as well.

If youre diagnosed with prostate cancer, you have a range of treatment options to consider based on your age, overall health and how early your cancer was caught the stages of prostate cancer vary depending on how it has advanced.

The treatment landscape is rapidly evolving, McKay said. In the last decade theres been the introduction of many more drugs that work better and make people live longer and live better.

Treatment options include prostate cancer surgery, radiation therapy, chemotherapy and hormone treatment. Your doctor could also recommend active surveillance, which involves monitoring your cancer for signs that its progressing.

Ask your provider any questions, Yu said, and take charge of your own health discussion.

See more here:
Prostate cancer symptoms: The warning signs you need to know - TODAY

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The process of scientists trying to understand how the coronavirus operates has been likened to detectives investigating a crime. To better understand the perpetrator, they first had to uncover its modus operandi in the human body, i.e. which cells it targets, and why.

These hotspots have recently been mapped in a study published in Cell Reports, where 28 SARS-CoV-2 and coronavirus-associated receptors and factors (SCARFS) were investigated as "accomplices" to the virus, serving as gateways for infection into various organ cells.

READ | Why check-ups for Covid-19 recoveries are important

Cause of death

Let's start with cause of death. Post-mortems confirm that victims had major lung damage inflicted by Covid-19-induced pneumonia. It also wreaks havoc on the heart, kidney, liver and gastrointestinal tract, and has been proven to havesome neurological impact on the brain.

"What causes the wide range of clinical phenotypes observed in people infected with SARS-CoV-2 is not yet understood," write the investigative scientists.

"It remains unclear which of these pathologies are caused by direct infection of the organs affected or indirect effects mediated by systemic inflammatory responses or comorbidities. A prerequisite to resolving these questions is to gain a better understanding of the tropism of the virus, i.e. which tissues and cell types are permissive to SARS-CoV-2 infection."

Partners in crime

This means that some cells have more coronavirus-friendly receptors than others, and are more willing to "invite the wolf in", especially when primed bycellular protease. In the case of this virus, scientists have already identified ACE2 receptors andTMPRSS2 protease as the most common "partners in crime".

But the researchers say there have to be more players at work due to the virus's high infection rate, which is what they undertook to investigate.

READ MORE | Could the MMR vaccine help prevent Covid-19? New trial may tell

Following your nose

For them, the real battle for infection takes place in the nose, more specifically, the nasal epithelium.

"The nasal epithelium expresses various combinations of factors that, in principle, could facilitate SARS-CoV-2 infection, but it also expresses robust basal levels of resistant factors, which may act as a strong protective barrier in this tissue."

Age may also have an impact on the nasal epithelium's ability to fight off the infection, where the protease undergoes a shift in regulation in young individuals.

Moving through the rest of the body, goblet and absorptive cells in the intestines and proximal tubule cells in the kidneys are more welcoming of the virus, with infection also found in the brain and lungs.

Men are the main target

Male parts like spermatogonial cells in the testes and prostate endocrine cells are also easily targeted by the coronavirus, which might explain men's vulnerability to the Covid-19. In contrast, in women, the ovaries and their cells are highly unlikely to be infected.

However, embryonic and placental development are at moderate risk of infection in pregnant women, but further research is needed.

"Because the basal expression level of these factors determines, at least in part, the tropism of the virus, this information is foundational to predict which tissues are more vulnerable to infection. These data are also important to guide and prioritise clinical interventions and pathological studies, including biopsies."

They highlight, however, that SCARF expression within and between individuals can be influenced by genetics and environmental factors and their "map" might not be representative of everyone.

Still, tracing the virus's potential footsteps throughout the body also reveals potential secret routes it might use to jump from host to host. With this guide, we might be able to finally catch up to the virus and stop it in its tracks.

READ | Coronavirus' weird trip inside cells might be its undoing, scientists say

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Compiled by Gabi Zietsman

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Mapping Covid-19's tracks as it attacks the body - Health24

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Abstract

Objective To evaluate and quantify the future risk of cardiovascular events in young adults with high blood pressure.

Design Systematic review and meta-analysis.

Data sources Medline, Embase, and Web of Science were searched from inception to 6 March 2020. Relative risks were pooled using a random effects model and expressed with 95% confidence intervals. Absolute risk difference was calculated. Dose-response relations between blood pressure and individual outcomes were assessed by a restricted cubic spline model.

Eligibility criteria for selecting studies Studies were selected that investigated the adverse outcomes of adults aged 18-45 with raised blood pressure. The primary study outcome was a composite of total cardiovascular events. Coronary heart disease, stroke, and all cause mortality were examined as secondary outcomes.

Results Seventeen observational cohorts consisting of approximately 4.5 million young adults were included in the analysis. The average follow-up was 14.7 years. Young adults with normal blood pressure had increased risk of cardiovascular events compared with those with optimal blood pressure (relative risk 1.19, 95% confidence interval 1.08 to 1.31; risk difference 0.37, 95% confidence interval 0.16 to 0.61 per 1000 person years). A graded, progressive association was found between blood pressure categories and increased risk of cardiovascular events (high normal blood pressure: relative risk 1.35, 95% confidence interval 1.22 to 1.49; risk difference 0.69, 95% confidence interval 0.43 to 0.97 per 1000 person years; grade 1 hypertension: 1.92, 1.68 to 2.19; 1.81, 1.34 to 2.34; grade 2 hypertension: 3.15, 2.31 to 4.29; 4.24, 2.58 to 6.48). Similar results were observed for coronary heart disease and stroke. Generally, the population attributable fraction for cardiovascular events associated with raised blood pressure was 23.8% (95% confidence interval 17.9% to 28.8%). The number needed to treat for one year to prevent one cardiovascular event was estimated at 2672 (95% confidence interval 1639 to 6250) for participants with normal blood pressure, 1450 (1031 to 2326) for those with high normal blood pressure, 552 (427 to 746) for those with grade 1 hypertension, and 236 (154 to 388) for those with grade 2 hypertension.

Conclusions Young adults with raised blood pressure might have a slightly increased risk of cardiovascular events in later life. Because the evidence for blood pressure lowering is limited, active interventions should be cautious and warrant further investigation.

Cardiovascular events are responsible for more than 18 million deaths each year, which is around one third of all global deaths.12 High blood pressure is a well recognised remediable risk factor for cardiovascular events. Currently, two different blood pressure thresholds are used to diagnose hypertension: the traditional threshold of 140/90 mm Hg3 and the newly recommended threshold of 130/80 mm Hg given in the 2017 guideline by the American College of Cardiology and American Heart Association.4 Although different criteria are implemented for diagnosing hypertension, their therapeutic recommendation is similar and largely driven by the risk of cardiovascular disease.34 Most randomised outcome studies have involved participants who are at high risk or are over the age of 55.5 Therefore frequently used risk prediction models or guidelines are mainly based on studies among older people,346 whereas the association between blood pressure and cardiovascular event risks among young adults is under studied. Although hypertension is traditionally a more prevalent disease in older people, recent epidemiological studies have shown that the incidence is progressively rising among the young.7

Further research is needed to determine whether cumulative exposure to raised blood pressure during young adulthood contributes to higher risks of cardiovascular events in later life. Systematic reviews or randomised control trials investigating the associations of raised blood pressure with risks of cardiovascular events among young adults are lacking. Only a limited number of observational studies exist.89101112131415161718192021222324 However, substantial heterogeneity has been observed, varying in risk thresholds and the associations with different disease outcomes. An Indian cohort study showed that the risk of cardiovascular mortality increased in participants aged 34-44 years with systolic blood pressure from the category 140-159 mm Hg,21 while in several other cohorts, the blood pressure threshold associated with cardiovascular events was around 120/80 mm Hg.8923 Additionally, Son and colleagues reported that higher measured blood pressure in early adulthood was associated with increased risks of all cardiovascular outcomes,8 whereas in the Harvard Alumni Health Study, the exposure-outcome association was exclusive of strokes.15

With these inconsistent findings in mind, an up-to-date understanding of the association of blood pressure with different cardiovascular outcomes is needed, which would help to refine strategies for primary prevention and to inform the design of future clinical trials. We conducted a systematic review and meta-analysis of published studies to quantify the association between blood pressure categories and the future risk of cardiovascular events in young adults. Additionally we assessed if increases in systolic and diastolic blood pressure differentially impacted distinctive clinical outcomes.

This study was conducted under a predefined protocol (supplementary appendix 1), following the recommendations of the Cochrane handbook25 and reporting in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analysis) statement.26 The protocol was amended once on 6 March 2020; the search end date and search strategies were updated. Extra statistical analyses were also performed. Additionally, the grading quality of this meta-analysis was reported and evaluated by using the GRADE (grading of recommendations assessment, Development and evaluation) approach.27 According to the protocol deviation process guide, these changes were considered minor protocol deviations.28

We considered studies to be eligible if they were longitudinal cohort studies that enrolled adults aged 18-45 years, and reported the association between increased blood pressure and the study outcomes. The primary study outcome was a composite of total cardiovascular eventscoronary heart disease, stroke, heart failure, other types of cardiovascular diseases, and any cardiovascular deaths. We examined coronary heart disease, stroke, and all cause mortality as secondary outcomes.

We excluded studies if they were review articles, case reports, cross sectional studies, or randomised controlled trials comparing efficacy of antihypertensive medications; or if the study population was complicated with some other overt diseases, including cardiovascular diseases, kidney disease, diabetes, pulmonary hypertension, cancers, hyperthyroidism, connective tissue disease, rheumatoid arthritis, mental diseases or obstructive sleep apnoea. We also excluded studies involving pregnant participants, critically ill patients, or those admitted to hospital, studies recording fewer than three groups of blood pressure strata, or providing insufficient data to allow for risk estimates to be calculated.

We searched Medline, Embase, and Web of Science for articles from inception to 6 March 2020. Supplementary appendix 2 gives the detailed search strategy that used several search terms: (hypertension OR blood pressure) AND (cardiovascular disease OR coronary artery disease OR coronary heart disease OR myocardial infarction OR ischaemic heart disease OR acute coronary syndrome OR stroke OR cerebrovascular accident OR cerebrovascular disease OR cardiovascular events OR cardiovascular deaths OR heart failure OR diabetes OR renal failure OR chronic kidney disease) AND (cohort OR follow up) AND (age OR young). No restrictions were applied based on sex, location, languages, or duration of follow-up. We searched the reference lists of the included studies and relevant review articles, and contacted authors of potentially eligible articles to request additional data. Hand searching from the Google Scholar, China National Knowledge Infrastructure, or Wanfang datasets was conducted for additional grey literature, including government reports, insurance reports, conference proceedings, and digital dissertations. We also searched ClincalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing or unpublished eligible studies. If duplicate studies were found from the same cohort that offered similar outcome measures, we included the studies reporting the most relevant data. However, if duplicate studies offered information for different outcomes, they were included in the pooled analysis for specific outcome analysis.

Two reviewers (DL and YC) screened all titles that met the inclusion criteria and then the remaining abstracts were screened. The full manuscripts were screened by the same reviewers to make the final decision for all included studies. Any disagreements were resolved by consensus.

Two reviewers (DL and YC) performed independent double data extraction. Core baseline and outcome data were extracted, including first author, year of publication, region/country, study type, year of enrolment, number and age of the included participants, follow-up duration, male sex proportion, body mass index, mean blood pressure level of each blood pressure stratum, the methods used for blood pressure measurement, and the study outcomes. Blood pressure was stratified into five subgroups: optimal blood pressure (systolic blood pressure <120 mm Hg and diastolic blood pressure <80 mm Hg), normal blood pressure (120-129 and 80-84 mm Hg), high normal blood pressure (130-139 and 85-89 mm Hg), grade 1 hypertension (140-159 and 90-99 mm Hg), and grade 2 hypertension (160 and 100 mm Hg) based on the 2018 European guideline.3 Optimal blood pressure was the reference category for relative risks. The information was obtained from published data or calculated by using the raw data.

We used the Newcastle-Ottawa scale to assess the characteristics and quality of included studies. Briefly, the scale is based on a star system and includes three broad perspectives: selection of the study groups, comparability of the groups, and ascertainment of the outcome of interest.29 Total score is calculated by summing the score for each answer. Studies are considered of good quality if the total score is at least 7/9. Two reviewers (DL and YC) independently conducted quality assessments of the included studies. Disagreements were resolved by discussion and further review. Publication bias was assessed by visual inspection of funnel plots and by Eggers statistical tests.30 We considered a P value less than 0.05 to be evidence of small study effects.

We used the STATA version 15.0 (Stata Corp, College Station, TX) software package to conduct random effects meta-analysis by using the inverse variance method for pooling log relative risks. Random effects was used because the studies were conducted over a wide range of settings in different populations. This approach required that heterogeneity be considered when making the pooled effect estimate. If possible, we chose to pool the risk estimates from primary studies, and when these data were not available, raw data were used to calculate unadjusted risk estimates. Pooled relative risks were expressed with 95% confidence intervals. The absolute risk difference was calculated by using the formula [(RR1)*I0], where RR indicates pooled relative risks and I0 is the incidence of cardiovascular events per 1000 person years among young adults with optimal blood pressure.31

We present benefit after one year of treatment in terms of number needed to treat for one year. This calculation assumed that the effect of treatment could help to lower the increased blood pressure to an optimal level and the event rate could be reduced to the same level as that in the population with optimal blood pressure. Number needed to treat was calculated directly as the reciprocal of the absolute risk difference between participants with increased blood pressure and optimal blood pressure.32 Additionally, we used the formula pdi*[(RR1)/RR] to calculate the population attributable fractions for each categorical blood pressure level in comparison to the reference category of optimal blood pressure, where pdi represents the proportion of total events in the population arising from the ith exposure category.33

In the dose-response analysis, we used restricted cubic splines to assess the pooled dose-response relation between blood pressure and individual outcomes. Nonlinear models were fitted and the results presented with 95% confidence intervals.34 We used mean values of the systolic blood pressure or diastolic blood pressure reported by the original studies, or calculated the average level by estimating the midpoint in each category. To enable the total person years of observation to be calculated, we included data from reports that specified total person time of follow-up, or sample size and median follow-up per person.

We used the 2 test to assess heterogeneity across studies, expressed as Cochrans Q and I2 statistics, together with 95% confidence intervals. Values of 0-25% represented minimal heterogeneity, 26-75% represented moderate heterogeneity, and values greater than 75% represented substantial heterogeneity.35

We performed meta-regression and stratified analyses to assess the potential sources of heterogeneity. Studies were stratified into different subgroups based on age (younger than or older than 30 years); body mass index (25 or <25); sample size (100000 or <100000); median follow-up duration (>20 or 20 years); year of enrolment (before or after 1980); population regions (Asia, Europe, or North America); and Newcastle-Ottawa scale scores (>7 or 7). For studies reporting subgroups stratified by sex, we combined results from the male subgroups and studies that were all male, which were then compared with the pooling results of the female subgroups. We separated studies based on male proportion (90% or <90%) to further explore the potential effect of sex distribution on the associations of high blood pressure and cardiovascular risks.

We conducted further sensitivity analyses by leaving out studies with high risk of bias21; removing studies with only male participants10131517222324 or military members10; excluding studies of retrospective design81924 or using non-equivalent outcome definitions924; or limiting studies to those involving only untreated participants,81213192023 using a mercury sphygmomanometer for blood pressure measurements,121314212223 or reporting some levels of adjustment.891011121315181920212223 All statistical tests were two sided and a P value less than 0.05 was considered statistically significant.

No patients or the public were involved in setting the research question or the outcome measures, nor were they involved in developing plans for recruitment, design, or implementation of the study. No patients or the public were asked to advise on interpretation or writing up of results. We had no way of directly contacting participants from the original studies.

From 57519 published records, 828 remained eligible for inclusion based on screening of the titles and abstracts. After reading the full manuscripts, a total of 17 studies were included in the analysis89101112131415161718192021222324 (fig 1). The studies examined 4533292 young adults (ranging from 3490 to 2488101 in each study), with an average follow-up of 14.7 years (ranging from 4.3 to 56.3 years in each study). Table 1 gives details of the study characteristics. Three of the studies were retrospective cohort studies and 14 were prospective. All studies reported the outcome of cardiovascular events (coronary heart disease or stroke) and only eight reported the outcome of all cause mortality.

Flowchart of selection of studies included in meta-analysis

Core characteristics of included studies

We found no evidence of publication bias across different blood pressure categories based on visual inspection of funnel plots and the results from Eggers tests (all P>0.05; supplementary appendix 3, fig S1). Table 2 reports Newcastle-Ottawa scale scores and quality assessment of the included studies; only one study scored lower than 7, indicating fair quality.21 All the other studies were recorded as good quality and low risk of bias based on total scores higher than 7. Most studies were rated as including representative participants for the general population. All but one study reported adequately on outcome ascertainment.19 According to the GRADE summary of evidence, the quality of evidence was rated as moderate to high for the outcomes of cardiovascular events, coronary heart disease and stroke, but low for all cause mortality except for the category of grade 2 hypertension (supplementary appendix 3, table S1).

Newcastle-Ottawa scale scores and quality assessment of included studies

During follow-up, 85674 cardiovascular events occurred. The event rate of cardiovascular events in young adults with optimal blood pressure was estimated to be 1.97 per 1000 person years (95% confidence interval 1.48 to 2.46). Figure 2 shows a graded, progressive association between blood pressure categories and the primary outcome. Young adults with normal blood pressure (relative risk 1.19, 95% confidence interval 1.08 to 1.31; risk difference 0.37, 95% confidence interval 0.16 to 0.61 per 1000 person years), high normal blood pressure (1.35, 1.22 to 1.49; 0.69, 0.43 to 0.97), grade 1 hypertension (1.92, 1.68 to 2.19; 1.81, 1.34 to 2.34), and grade 2 hypertension (3.15, 2.31 to 4.29; 4.24, 2.58 to 6.48 per 1000 person years) had increased risk of cardiovascular events compared with those with optimal blood pressure.

Forest plot of relative risks of cardiovascular events across blood pressure categories compared with optimal blood pressure. RR=relative risk

The heterogeneity of relative risks was substantial and statistically significant across studies (Q=42.5, I2=74.1%, P<0.001 for normal blood pressure; Q=104.2, I2=85.6%, P<0.001 for high normal blood pressure; Q=175.8, I2=91.5%, P<0.001 for grade 1 hypertension; Q=216.6, I2=95.8%, P<0.001 for grade 2 hypertension; fig 2). Therefore, we conducted sensitivity analyses across various scenarios to assess whether and to what extent the heterogeneity could be reduced. As a result, the heterogeneity reduced from substantial to moderate (supplementary appendix 3, table S2) when the analyses were confined to studies including only untreated participants81213192023 or when a mercury sphygmomanometer was used for blood pressure measurements.121314212223

To further explore the source of heterogeneity, we performed stratified analyses in the predefined subgroups. The findings of increased cardiovascular risk associated with high blood pressure were consistently observed in most of the stratified analyses (table 3). Differences in study sample size, study quality, follow-up duration, population regions, or body mass index were not major sources of heterogeneity. Additionally, summary estimates of the risk increasing association were identical for both sexes. The stratification based on male proportion (90% v <90%) did not reveal a major difference in the exposure-outcome associations, which suggested that the disparity in sex proportion did not have an important effect on our findings. Also, the pattern of association did not change materially after removing studies that had all male participants10131517222324 or only military members.10 Although the year of enrolment for individual studies could be a source of heterogeneity, we did not observe important secular trends when pooling studies conducted before or after the 1980s (table 3). However, the associations of blood pressure above high normal blood pressure level and risks of cardiovascular events were more evident in young adults aged over 30 years, suggesting that age could be one of the sources of study heterogeneity.

Stratification analysis of pooled relative risks for cardiovascular events

The event rates for coronary heart disease, stroke, and all cause mortality in young adults with optimal blood pressure level were estimated to be 1.07 (95% confidence interval 0.77 to 1.38), 0.94 (0.67 to 1.21), and 3.12 (1.40 to 4.84) per 1000 person years, respectively. The relative risk for coronary heart disease was 1.09 (95% confidence interval 0.99 to 1.21; risk difference 0.10, 95% confidence interval 0.01 to 0.22 per 1000 person years) for normal blood pressure, 1.25 (1.18 to 1.34; 0.27, 0.19 to 0.36) for high normal blood pressure, 1.65 (1.48 to 1.84; 0.70, 0.51 to 0.90 ) for grade 1 hypertension, and 2.27 (1.86 to 2.78; 1.36, 0.92 to 1.90) for grade 2 hypertension compared with optimal blood pressure (fig 3).

Forest plot of relative risks of coronary heart disease across blood pressure categories compared with optimal blood pressure. RR=relative risk

Similarly, young adults with normal blood pressure (relative risk 1.14, 95% confidence interval 1.03 to 1.27; risk difference 0.13, 95% confidence interval 0.03 to 0.25 per 1000 person years), high normal blood pressure (1.27, 1.15 to 1.39; 0.25, 0.14 to 0.37), grade 1 hypertension (1.89, 1.56 to 2.28; 0.84, 0.53 to 1.20), and grade 2 hypertension (2.87, 2.07 to 3.96; 1.76, 1.01 to 2.78) had increased risk of stroke compared with those with optimal blood pressure (fig 4). For all cause mortality, the risk increased above a blood pressure of 140/90 mm Hg, with a 42% higher risk for grade 1 hypertension (relative risk 1.42, 95% confidence interval 1.18 to 1.71; risk difference 1.31, 95% confidence interval 0.56 to 2.22 per 1000 person years) and a double risk for grade 2 hypertension (2.01, 1.38 to 2.93; 3.15, 1.19 to 6.02; fig 5).

Forest plot of relative risks of stroke across blood pressure categories compared with optimal blood pressure. RR=relative risk

Forest plot of relative risks of all cause mortality across blood pressure categories compared with optimal blood pressure. RR=relative risk

The heterogeneity of relative risks was moderate to substantial for the outcomes of stroke and all cause mortality across high normal blood pressure (Q=25.4, I2=52.8%, P=0.01 for stroke; Q=21.3, I2=67.1%, P=0.003 for all cause mortality; fig 4 and fig 5), grade 1 hypertension (Q=86.3, I2=86.1%, P<0.001 for stroke; Q=93.8, I2=92.5%, P<0.001 for all cause mortality; fig 4 and fig 5), and grade 2 hypertension strata (Q=25.7, I2=76.6%, P<0.001 for stroke; Q=36.5, I2=89.0%, P<0.001 for all cause mortality; fig 4 and fig 5). However, for the normal blood pressure stratum (Q=10.6, I2=24.4%, P=0.23 for stroke; Q=10.6, I2=0.0%, P=0.46 for all cause mortality; fig 4 and fig 5) and coronary heart disease outcome associated with normal blood pressure (Q=13.6, I2=33.7%, P=0.14; fig 3), high normal blood pressure (Q=16.5, I2=21.1%, P=0.23; fig 3), and grade 2 hypertension (Q=9.7, I2=27.8%, P=0.21; fig 3), we did not observe any significant heterogeneity.

Assuming that the effect of treatment could help to lower increased blood pressure to the optimal level and the risk attributable to raised blood pressure was removed by treatment, the number needed to treat for one year to prevent one cardiovascular event was estimated to be 2672 (95% confidence interval 1639 to 6250) for those with normal blood pressure, 1450 (1031 to 2326) for those with high normal blood pressure, 552 (427 to 746) for those with grade 1 hypertension, and 236 (154 to 388) for those with grade 2 hypertension. Figure 6 shows the estimated number needed to treat to prevent one event of coronary heart disease, stroke, and all cause mortality. Generally, the population attributable fraction for the cardiovascular events associated with raised blood pressure was 23.8% (95% confidence interval 17.9% to 28.8%). The attributional effects increased across blood pressure increments: 2.1% (1.0% to 3.1%) for normal blood pressure, 8.6% (6.0% to 10.9%) for high normal blood pressure, and 13.0% (11.0% to 14.8%) for a hypertensive blood pressure level (fig 6). Similar results were observed for coronary heart disease and stroke (fig 6).

Population attributable fraction and number needed to treat for one year for different study outcomes across blood pressure categories. NNT=number needed to treat

The risk increasing associations of blood pressure categories with cardiovascular events, coronary heart disease, and stroke were similar when using mean systolic and diastolic blood pressure values. Figure 7 shows that systolic blood pressure higher than 120-129 mm Hg was associated with an increased risk of cardiovascular events, coronary heart disease, and stroke in a dose responsive manner (fig 7, top panel). Similarly, the association of diastolic blood pressure with risk of cardiovascular events, coronary heart disease, and stroke monotonically increased from a level of 80 mm Hg (fig 7, bottom panel). For all cause mortality, the risk associated with systolic blood pressure increased from a level above 150-160 mm Hg, and an association with diastolic blood pressure was observed above 80-90 mm Hg. Independently, every 10 mm Hg increment of systolic blood pressure was associated with a 5% increased risk of cardiovascular events (relative risk 1.05, 95% confidence interval 1.03 to 1.06), a 3% increased risk of coronary heart disease (1.03, 1.02 to 1.04), a 4% increased risk of stroke (1.04, 1.02 to 1.05), and a 2% increased risk of all cause mortality (1.02, 1.01 to 1.03). For diastolic blood pressure, each 5 mm Hg increment resulted in a 4% increased risk of cardiovascular events (1.04, 1.03 to 1.05), a 2% increased risk of coronary heart disease (1.02, 1.02 to 1.03), a 3% increased risk of stroke (1.03, 1.02 to 1.04), and a 2% increased risk of all cause mortality (1.02, 1.01 to 1.03).

Nonlinear dose-response analysis of systolic blood pressure (top panel) and diastolic blood pressure (bottom panel) and risk of cardiovascular events, coronary heart disease, stroke, and all cause mortality. Shaded areas indicate 95% confidence intervals for corresponding coloured lines

Limited evidence exists of an association between higher blood pressure and the risk of clinically manifest cardiovascular events in young adults. A systematic review of the literature provided insight into this process. Our study was based on 17 studies with approximately 4.5 million young adults and yielded three main findings. Firstly, we observed continuous and graded associations between categorical blood pressure increments and increasing risks of cardiovascular events, coronary heart disease, stroke, and all cause mortality. The risk increasing association with cardiovascular events was consistent in participants across different regions, but it was more evident in those older than 30 years. Secondly, the population attributable fractions for cardiovascular events from increased blood pressure were high, contributing to nearly a quarter of cardiovascular events in young adults. Thirdly, a similar pattern of the associations with different study outcomes was observed in the dose-response relation of systolic and diastolic blood pressure.

The strengths of the present study are the large sample size and the long follow-up duration, with a total of approximately 4.5 million participants at risk and an average follow-up of 14.7 years. The associations of high blood pressure with various study outcomes were examined across different blood pressure categories in our study. Unlike most of the previous studies assessing only normotension and hypertension,3637 the use of comprehensive blood pressure strata enabled healthcare workers to determine a detailed association of blood pressure with cardiovascular events. Additionally, restricted cubic spline models were used to assess the dose-response relation between blood pressure and future risk of individual outcomes, providing an estimate of the independent associations of systolic and diastolic blood pressure with different study outcomes. Moreover, consistent results of the pooled estimates from the stratified and sensitivity analyses across various scenarios supported the robustness of the study findings.

However, limitations also exist. Firstly, this review was not preregistered. However, it was conducted under a predefined protocol and followed the guidance of the Cochrane handbook.25 The items recommended by the PRISMA statement were also provided, which reduced the manipulation and improved the transparency.26 Secondly, considerable heterogeneity was observed in the design of the included studies. The protocols for blood pressure measurement were not equivalent in different cohorts. Population characteristics, including age range, treated or untreated status, presence or absence of hyperglycaemia, hyperuricaemia, and dyslipidaemia might also have contributed to the heterogeneity of the included studies. As a result, although the risk increasing association remained robust across various scenarios, high levels of statistical heterogeneity generally persisted and could not be reduced in stratified and sensitivity analyses. Finally, pooling results from studies that were all male with other mixed studies could have biased the results. However, stratification analyses by sex distribution (male proportion) were conducted and showed that the summary estimates of the risk increasing association were identical for both sexes and in studies with different proportions of male participants. However, analysis of the female population was based on only four studies and the calculated estimates for women were highly uncertain.

Associations between high blood pressure and cardiovascular risk have long been recognised and found to be age specific, but most of the outcome studies were carried out in middle aged or older populations.383940 Previous cohort studies and overviews have shown that high blood pressure is robustly associated with increased risk of total cardiovascular events and all cause mortality in middle aged or older populations.123384142 The Suita Study reported that the cardiovascular risk was 2.04 (95% confidence interval 1.19 to 3.48) for normal blood pressure, 2.46 (1.46 to 4.14) for high normal blood pressure, 2.62 (1.59 to 4.32) for grade 1 hypertension, and 3.95 (2.37 to 6.58) for grade 2 hypertension compared with optimal blood pressure in a population over 50 years old. Additionally, each 10 mm Hg decrement in systolic blood pressure was predicted to result in a reduction in cardiovascular events of around 25-40%.43 Our findings further support the idea that the relative risks for cardiovascular events associated with various blood pressure categories vary among different age groups.39 We show that the relative risks for cardiovascular events in each blood pressure category were all lower among young adults. For every 10 mm Hg increment of systolic blood pressure and every 5 mm Hg increment of diastolic blood pressure, a 4-5% increase in risk was found.

Relative risk estimates for disease incidence are of limited clinical utility given the uncertainty about the incidence rate of the reference group, referring to the optimal blood pressure sample in our study.44 The absolute risk for cardiovascular events in young adults with optimal blood pressure is low compared with the older population. The Multi-Ethnic Study of Atherosclerosis, a population based study that enrolled adults aged 45-84 years who were free of clinical cardiovascular diseases, showed that the event rates for all cardiovascular events in participants with a blood pressure of 120-139 mm Hg were 5.6-24.3 per 1000 person years. For those with a blood pressure of 140-159 mm Hg, the event rates were 7.4-36.9 per 1000 person years and rose to a level of 16.7-37.1 per 1000 person years when blood pressure was higher than 160 mm Hg.45 Despite the relatively low absolute risk, the difference in absolute risk (at least four additional cardiovascular events per 10000 person years in those with increased blood pressure) should not be overlooked owing to an increasing prevalence of hypertension in young adults.74647

The population attributable fraction for cardiovascular events from raised blood pressure in young adults was higher than the corresponding blood pressure levels in older people.2048 This finding suggests that the impact of high blood pressure on cardiovascular events is more detrimental among young people, especially above the level of 140/90 mm Hg. The reason for this effect is probably driven by age. The contributing impacts of other risk factors, including previous cardiovascular disease, impaired lung function, or longer duration of diabetes could make a greater difference at an older age and so the contributing role of hypertension diminishes4849; however, for young adults, with fewer comorbidities or risk factors, the role of increased blood pressure dominates.

Systolic and diastolic blood pressure each independently influenced cardiovascular outcomes in young adults. The pathophysiological basis of high blood pressure in young adults and older people seems to be different.550 White coat hypertension, a hyperadrenergic state, a higher prevalence of secondary hypertension, and hypertension caused by peripheral blood pressure amplification are more commonly seen in young adults. Conversely, loss of arterial compliance and increased arterial stiffness are often found in older people, concurrent with increasing systolic blood pressure and decreasing diastolic blood pressure.55051 Understanding such pathophysiological links among different age groups could help us to better understand what we found in this study. The Monica, Risk, Genetics, Archiving and Monograph project, a large population based cohort, found a gradual age related shift from diastolic blood pressure to both diastolic blood pressure and systolic blood pressure, and eventually to systolic blood pressure as a risk factor for cardiovascular events.52 This finding is consistent with our results, with systolic and diastolic blood pressure independently and comparatively associated with the risk of cardiovascular events. However, outcome specific association was observed in terms of systolic blood pressure and diastolic blood pressure. For systolic blood pressure, the risk of stroke and coronary heart disease was identical in pattern and increased from the level of 120 mm Hg, while for all cause mortality the risk apparently rose from the level of 150-160 mm Hg. For diastolic blood pressure, the burden for stroke was more evident than coronary heart disease and all cause mortality. Given that the prevalence of isolated diastolic hypertension is more pronounced in young adults, special attention should be paid to this population.53

Uncertainty remains about antihypertensive treatments in young adults with increased blood pressure. Because our findings were based on observational studies, not interventional, no direct data were yielded relating to antihypertensive treatment. According to the hypertension guidelines, antihypertensive treatment is beneficial for those with a 10 year atherosclerotic cardiovascular disease risk of more than 10%.34 However, the frequently used risk prediction models have not been validated in young adults and evidence to support the recommendation of starting antihypertensive drugs is insufficient.5455 Therefore, active interventions should be cautious. Based on our findings, to prevent one cardiovascular event, the number needed to treat for one year was estimated to be 2672, 1450, 552, and 236 for normal blood pressure, high normal blood pressure, grade 1 hypertension, and grade 2 hypertension, respectively. These data suggest a lower likelihood of treatment benefit, especially for those with normal and high normal blood pressure. Our results could inform healthcare professionals about the effort needed to achieve a particular outcome and provide insights into the design of future clinical trials.31

Without a defined association between high blood pressure and cardiovascular risks, developing and implementing standardised treatment advice and guidelines that include young adults is challenging. Although ongoing studies for young adults are currently being investigated, most are still at the initial stages and the long term impact on cardiovascular end points remains to be determined.565758 Therefore, the insights provided in our study could help to refine strategies for primary prevention and might have important implications for future research.

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Association between high blood pressure and long term cardiovascular events in young adults: systematic review and meta-analysis - The BMJ

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The genome editor CRISPR, whose invention is at the heart of a fierce patent battle, typically uses an RNA molecule (red) to guide a DNA-cutting enzyme such as Cas9 (orange) to a DNA sequence (blue) targeted for cutting.

By Jon CohenSep. 11, 2020 , 6:40 PM

The long-running patent battle over CRISPR, the genome editor that may bring a Nobel prize and many millions of dollars to whoever is credited with its invention, has taken a new twist that vastly complicates the claims made by a team led by the University of California.

The Patent Trial and Appeal Board (PTAB) ruled 10 September that a group led by the Broad Institute has priority in its already granted patents for uses of the original CRISPR system in eukaryotic cells, which covers potentially lucrative applications in lab-grown human cells or in people directly. But the ruling also gives the University of California group, which the court refers to as CVC because it includes the University of Vienna and scientist Emmanuelle Charpentier, a leg up on the invention of one critical component of the CRISPR tool kit.

This is a major decision by the PTAB, says Jacob Sherkow, a patent attorney at the University of Illinois at Urbana-Champaign who has followed the case closely but is not involved. Theres some language in the opinion from today thats going to cast a long shadow over the ability of the [CVC] patents going forward.

Jennifer Doudna, a biochemist at the University of California at Berkeley, and Charpentier, now with the Max Planck Institute, first published evidence that the bacteria-derived CRISPR system could cut targeted DNA in June 2012, seven months before the Broad team led by Feng Zhang published its own evidence it could be a genome editor. But the CVC team did not show in its initial paper that CRISPR worked inside eukaryotic cells as Zhangs team did in its report, even though the original CVC patent application broadly attempted to cover any use of the technology. The U.S. Patent and Trademark Office issued several CRISPR-related patents to Broad beginning in 2014, sparking a legal a battle in 2016 based on CVC claims of patent interference. That led to a first PTAB trial, which seemed to deliver a mixed verdict, ruling that the eukaryotic CRISPR and other uses of the genome editor were separate inventions, patentable by Broad and CVC respectively. Unsatisfied, CVC took the issue to a federal court, which denied its appeal.

CVC subsequently filed new claims that led PTAB to declare a second interference. The board this time did a more direct comparison of which group had the best evidence for the first demonstration that CRISPR worked in eukaryotic cells. The PTAB ruling did not accept CVC arguments that it crossed this line first, giving the priority edge to the Broad.

This doesnt settle the dispute, however, but instead requires that CVC provide more evidence at a future hearing that it was first. The interference [hearing] is going ahead all the way this time to determine who was the first to invent, says Catherine Coombs, a patent attorney at the U.K legal firm Murgitroyd who has not been involved in the case but handled other CRISPR litigation in Europe. Coombs notes that theres a large gap between the CRISPR patent environment in the United States and Europe, where CVC has won the upper hand in the European Union patent office.

Sherkow anticipates the PTAB will face a tough, complex decision. Its going to need to subpoena Doudna and subpoena Zhang and subpoena a bunch of graduate students and put a bunch of eight-year-old lab notebooks in evidence, says Sherkow.

CRISPR, which typically comprises a DNA-cutting enzyme known as Cas9 and a molecule that guides it to a specific DNA sequence, often is compared to molecular scissors. A key dispute in the patent battle focuses on the guide component. Zhangs first description of CRISPR working in eukaryotic cells used a guide that combined two RNA molecules while CVCs use relied on a single RNA to do the same thing. This single molecule guide RNA now is the standard tool in the field.

A statement from a University of California spokesperson says it is "pleased" with the new ruling, noting that it denied several of the Broads motions. The PTAB "has ruled in our favor in most instances and will continue with the interference proceeding to determine which party was the first to invent CRISPR in eukaryotes, the statement says. [W]e remain confident that the PTAB will ultimately recognize that the Doudna and Charpentier team was first to invent the CRISPR-Cas9 technology in eukaryotic cells.

A statement issued by the Broad calls for something akin to a peace treaty. Although we are prepared to engage in the process before the PTAB and are confident these patents have been properly issued to Broad, we continue to believe it is time for all institutions to move beyond litigation and instead work together to ensure wide, open access to this transformative technology, the statement says. The best thing, for the entire field, is for the parties to reach a resolution and for the field to focus on using CRISPR technology to solve todays real-world problems.

Many observers of the patent battle long have hoped that the Broad and CVC will reach a settlement, but Sherkow thinks its less likely now. Almost every outcome is stacked in Broads favor, he says. If the CVC wins, he says, they will have the patent for the single molecule guide, but the Broad will not lose its eukaryotic patent and, at worst, will have to share it. If CVC loses, theyre toast, they come away empty, says Sherkow. But Ive been wrong about settlement before so theres every expectation that Ill be wrong again.

The PTAB ruling does not specify a date for its next hearing.

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The latest round in the CRISPR patent battle has an apparent victor, but the fight continues - Science Magazine

Recommendation and review posted by Bethany Smith

One of the major challenges facing gene therapy a way to treat disease by replacing a patients defective genes with healthy ones is that it is difficult to safely deliver therapeutic genes to patients without the immune system destroying the gene, and the vehicle carrying it, which can trigger life-threatening widespread inflammation.

Three decades ago researchers thought that gene therapy would be the ultimate treatment for genetically inherited diseases like hemophilia, sickle cell anemia, and genetic diseases of metabolism. But the technology couldnt dodge the immune response.

Since then, researchers have been looking for ways to perfect the technology and control immune responses to the gene or the vehicle. However, many of the strategies tested so far have not been completely successful in overcoming this hurdle.

Drugs that suppress the whole immune system, such as steroids, have been used to dampen the immune response when administering gene therapy. But its difficult to control when and where steroids work in the body, and they create unwanted side effects. My colleague Mo Ebrahimkhani and I wanted to tackle gene therapy with immune-suppressing tools that were easier to control.

I am a medical doctor and synthetic biologist interested in gene therapy because six years ago my father was diagnosed with pancreatic cancer. Pancreatic cancer is one of the deadliest forms of cancer, and the currently available therapeutics usually fail to save patients. As a result, novel treatments such as gene therapy might be the only hope.

[Read: These tech trends defined 2020 so far, according to 5 founders]

Yet, many gene therapies fail because patients either already have pre-existing immunity to the vehicle used to introduce the gene or develop one in the course of therapy. This problem has plagued the field for decades, preventing the widespread application of the technology.

Traditionally scientists use viruses from which dangerous disease-causing genes have been removed as vehicles to transport new genes to specific organs. These genes then produce a product that can compensate for the faulty genes that are inherited genetically. This is how gene therapy works.

Though there have been examples showing that gene therapy was helpful in some genetic diseases, they are still not perfect. Sometimes, a faulty gene is so big that you cant simply fit the healthy replacement in the viruses commonly used in gene therapy.

Another problem is that when the immune system sees a virus, it assumes that it is a disease-causing pathogen and launches an attack to fight it off by producing antibodies and immune response just as happens when people catch any other infectious viruses, like SARS-CoV-2 or the common cold.

Recently, though, with the rise of a gene-editing technology called CRISPR, scientists can do gene therapy differently.

CRISPR can be used in many ways. In its primary role, it acts as a genetic surgeon with a sharp scalpel, enabling scientists to find a genetic defect and correct it within the native genome in desired cells of the organism. It can also repair more than one gene at a time.

Scientists can also use CRISPR to turn off a gene for a short period of time and then turn it back on, or vice versa, without permanently changing the letters of DNA that makes up our genome. This means that researchers like me can leverage CRISPR technology to revolutionize gene therapies in the coming decades.

But to use CRISPR for either of these functions, it still needs to be packaged into a virus to get it into the body. So some challenges, such as preventing the immune response to the gene therapy viruses, still need to be solved for CRISPR-based gene therapies.

Being trained as a synthetic biologist, I teamed up with Ebrahimkhani to use CRISPR to test whether we could shut down a gene that is responsible for the immune response that destroys the gene therapy viruses. Then we investigated whether lowering the activity of the gene, and dulling the immune response, would allow the gene therapy viruses to be more effective.

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CRISPR can precisely remove even single units of DNA. KEITH CHAMBERS/SCIENCE PHOTO LIBRARY/Getty Images

A gene called Myd88 is a key gene in the immune system and controls the response to bacteria and viruses, including the common gene therapy viruses. We decided to temporarily turn off this gene in the whole body of lab animals.

We injected animals with a collection of the CRISPR molecules that targeted the Myd88 gene and looked to see whether this reduced the number of antibodies that were produced to specifically fight our gene therapy viruses. We were excited to see that the animals that received our treatment using CRISPR produced less antibodies against the virus.

This prompted us to ask what happens if we give the animal a second dose of the gene therapy virus. Usually, the immune response against a gene therapy virus prevents the therapy from being administered multiple times. Thats because after the first dose, the immune system has seen the virus, and on the second dose, antibodies swiftly attack and destroy the virus before it can deliver its cargo.

We saw that animals receiving more than one dose did not show an increase in antibodies against the virus. And, in some cases, the effect of gene therapy improved compared with the animals in which we had not paused the Myd88 gene.

We also did a number of other experiments that proved that tweaking the Myd88 gene can be useful in fighting off other sources of inflammation. That could be useful in diseases like sepsis and even COVID-19.

While we are now beginning to improve this strategy in terms of controlling the activity of the Myd88 gene. Our results, now published in Nature Cell Biology, provide a path forward to program our immune system during gene therapies and other inflammatory responses using the CRISPR technology.

This article is republished from The Conversation by Samira Kiani, Associate Professor of Pathology, University of Pittsburghunder a Creative Commons license. Read the original article.

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How CRISPR is tackling the troubling immune response thats plagued gene therapy until now - TNW

Recommendation and review posted by Bethany Smith

AUSTIN, Texas One of the biggest scientific advances of the last decade is getting better thanks to researchers at The University of Texas at Austin; the University of California, Berkeley; and Korea University. The team has developed a new tool to help scientists choose the best available gene-editing option for a given job, making the technology called CRISPR safer, cheaper and more efficient. The tool is outlined in a paper out today in Nature Biotechnology.

The CRISPR gene-editing technique holds tremendous potential to improve human health, agriculture and the future of people on the planet, but the challenge lies in the delicate nature of gene editing there is almost no room for error.

To edit genes, scientists use dozens of different enzymes from a naturally occurring system called CRISPR. Researchers locate a problematic DNA sequence and use these specialized enzymes to snip it as if using a pair of scissors, allowing genetic material to be added, removed or altered. But these scissors are not perfect. Accuracy and effectiveness vary by the CRISPR enzyme and the project. The new tool guides users, so they can pick the best CRISPR enzyme for their high-stakes gene edit.

We designed a new method that tests the specificity of these different CRISPR enzymes how precise they are robustly against any changes to the DNA sequence that could misdirect them, and in a cleaner way than has ever been done before, said Steve Jones, a UT research scientist who co-wrote the paper with Ilya Finkelstein, an associate professor of molecular biosciences.

Problems can occur when a CRISPR enzyme targets the wrong sections of DNA. Each CRISPR enzyme has strengths and weaknesses in editing different sequences, so the researchers set out to create a tool to help scientists compare the different enzymes and find the best one for a given job.

CRISPR wasnt designed in a lab. It wasnt made by humans for humans. It was made by bacteria to defend against viruses, said John Hawkins, a Ph.D. alumnus who was recently with UTs Oden Institute for Computational Engineering and Sciences. There is incredible potential for its use in medicine, but the first rule of medicine is do no harm. Our work is trying to make CRISPR safer.

The team of researchers developed a library of DNA sequences and measured how accurate each CRISPR enzyme was, how long it took the enzyme to edit the sequences and how precisely they edited the sequence. For some tasks the commonly used enzyme CRISPR-Cas9 worked best; in others, different enzymes performed much better.

Its like a standardized test, Hawkins said. Every student gets the same test, and now you have a benchmark to compare them.

The tool allows scientists to choose the best enzyme for editing on the first try, so the process becomes more efficient and cheaper. Additionally, it gives scientists information about where mistakes are most likely to occur for each enzyme, saving time.

This technique gives us a new way to reduce risk, Jones said. It allows gene edits to be more predictable.

Nicole V. Johnson, Kuang Hu, James R. Rybarski, William H. Press and Ilya J. Finkelstein of The University of Texas at Austin; Cheulhee Jung of Korea University; and Janice S. Chen and Jennifer A. Doudna of University of California, Berkeley, contributed to the research.

The research was funded by a College of Natural Sciences Catalyst Grant, The Welch Foundation and the National Institutes of Health.

See original here:
Matching CRISPR to the Job Improves the Safety, Efficiency of the Gene-Editing Tool - UT News | The University of Texas at Austin

Recommendation and review posted by Bethany Smith

Broadcast Date: October 6, 2020Time: 8:00 am PT, 11:00 am ET, 17:00 CET

Next Spring marks the tenth anniversary of two key moments in the annals of CRISPR. In San Juan, Puerto Rico, Jennifer Doudna, PhD and Emmanuelle Charpentier, PhD discussed a collaboration that would culminate in an immortal paper that repurposed CRISPR-Cas9 into a programmable gene targeting technology. Meanwhile, Feng Zhang heard about CRISPR for the first time, setting him on course to become one of the first investigators to demonstrate genome editing in mammalian cells.

Since the publication of those classic reports in 201213, CRISPR has catalyzed a revolution in genome editing, empowering basic researchers around the world, spawning a multibillion-dollar biotech industry, and showing signs of genuine promise in the clinic. But CRISPR has also been misapplied, notably in the creation of CRISPR babies in 2018, prompting calls for a moratorium on germline editing.

Kevin Davies, PhD, founding executive editor of The CRISPR Journal, has chronicled these events in his new book, Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing. This GEN keynote webinar takes place on the official publication day of the book. Davies will share highlights and insights from his reporting over the past few years and consider some of the exciting new directions that CRISPR will empower in the years ahead.

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelists.

About GEN KEYNOTE webinars:

GEN invites renowned experts to lecture on topics of broad interest to the biotechnology and biomedical community. Look for more GEN KEYNOTE webinars in 2020!

Produced with support from:

Excerpt from:
Heroes and Villains: Reflections on the CRISPR Revolution - Genetic Engineering & Biotechnology News

Recommendation and review posted by Bethany Smith

The fight against the novel coronavirus is putting plenty of healthcare ETFs in the spotlight this year, including the ARK Genomic Revolution Multi-Sector Fund (CBOE: ARKG), but theres much more to the ARKG story.

In fact, ARKG was one of the best-performing healthcare ETFs prior to COVID-19 becoming part of the daily lexicon. Thats a trajectory the actively managed ARK fund can continue when the virus is defeated due to its exposure to disruptive themes, including CRISPR.

Looking ahead, CRISPR-based innovations to accelerate given the technologys ease of use, cost-efficacy, growing body of research surrounding its safety, and AI-powered CRISPR nuclease selection tools. CRISPR could also be utilized to address some of the most prominent healthcare problems, which opens up a significant investment opportunity in monogenic diseases.

In a recent Harvard study, CRISPR gene editing transformed white fat into brown fat that burns energy and can contribute to weight loss, ARK analyst Ali Urman wrote in a recent report. The engineered cells helped mice avoid weight gain and potentially diabetes, despite a high fat diet.

CRISPR can cut DNA/RNA at a single point or in stretches; insert DNA/RNA and create novel gene sequences; activate and silence genes without making permanent changes; regulate protein expression levels epigenetically; record and timestamp biological events; track the movement of specific biological molecules; identify the presence of specific cancer mutations and bacteria; locate molecules without making changes; target and destroy specific viral and bacterial DNA and RNA; interrogate gene function multiplexed, and activate drug release at a specified trigger.

As the aforementioned Harvard study notes, theres a big opportunity for CRISPR as it pertains to fighting to obesity and that could be meaningful for long-term ARKG investors.

This study could have profound implications for CRISPRs total available market. In the United States, more than 34 million people have diabetes and the medical costs and loss of work wages associated with it are valued at $327 billion annually, notes ARKs Urman. If CRISPR were to be effective in increasing insulin sensitivity, CRISPRs total available market would expand significantly, if not exponentially.

ARKG includes companies that merge healthcare with technology and capitalize on the revolution in genomic sequencing. These companies try to better understand how biological information is collected, processed, and applied by reducing guesswork and enhancing precision; restructuring health care, agriculture, pharmaceuticals, and enhancing our quality of life.

For more on disruptive technologies, visit our Disruptive Technology Channel.

The opinions and forecasts expressed herein are solely those of Tom Lydon, and may not actually come to pass. Information on this site should not be used or construed as an offer to sell, a solicitation of an offer to buy, or a recommendation for any product.

Read the rest here:
CRISPR Benefits Available in This Genomics ETF - ETF Trends

Recommendation and review posted by Bethany Smith

CRISPR represents a new frontier in gene editing. In comparison to other currently available technologies, it is a less expensive, more specific and simpler-to-use gene editing tool but is not without its criticism or concerns.

Photo: Unsplash

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Gene editing is often discussed and presented in the context of revolutionizing treatment and diagnostics. In 2012, Jennifer Doudna and Emmanuelle Charpentier demonstrated the potential of CRISPR, which made the promise of gene editing therapies more tangible.

However, COVID-19 has brought to the fore additional applications, most notably exploring how CRISPR can be used as a mechanism to develop non-gene based therapies. Once the process is refined, it could represent another notable step forward for the healthcare sector, although several regulatory hurdles still remain before CRISPR manufactured non-gene editing therapies are widespread.

The CRISPR technology works by coding for a specific gene sequence using guide RNA. When the appropriate DNA sequence is found, the Cas9 protein, working as a pair of scissors, cuts the DNA at the desired location. Once the cut has been made, the gene can be disabled, or missing genetic information can be inserted or replaced.

Due to its characteristics, CRISPR represents a new frontier in gene editing; in comparison to other currently available technologies, it is a less expensive, more specific and simpler-to-use gene editing tool.

The technology is not without its criticism or concerns. Most notably, there is the possibility of off-target mutations, whereby cuts are made in unintended DNA sequences. Additionally, ethical questions related to gene editing as a technology overall remain pervasive among policy makers and the public alike. Fortunately, increased study and greater exposure to the technology are lessening some of these concerns, and it continues to represent a potential and long-awaited therapeutic option for many genetic, and often rare, diseases, for many of which treatments have remained elusive.

COVID-19 and the Ebola epidemic in the mid-2010s illustrated the lengthy time lag of developing preventative therapies. CRISPR technology has the potential to overcome this challenge by significantly accelerating the development of vaccines or therapeutic options to respond to pandemics. This is because CRISPR technology is based on a naturally occurring gene editing system that is found in bacteria, which can be used to fight viruses.

Increased urbanization and contact between different world regions is likely to lead to an increase in the frequency of epidemics, and this new reality has spurred increased interest in CRISPR as a means to quickly respond to disease outbreaks, or even unpredictable seasonal infections. A quick response can help protect healthcare professionals in the short term, and embrace the promise of prevention is better than treatment.

There are a range of different applications for using CRISPR in the development of therapeutic solutions.

Traditional vaccines typically consist of a weakened or dead strand of the virus that it is meant to inoculate patients from viruses. When developing a vaccine, the manufacturer must select viral strands, which are then either grown and incubated in hen eggs or cells.

CRISPR can be used to modify the incubator to increase viral products, which reduces the number of eggs or cells needed in the manufacturing process.

CRISPR technology can be used to engineer B cells, a white blood cell that produces the antibodies that in turn combat pathogens. Using CRISPR, B cells can be injected into patients and provide them with the antibodies to an infection, such as COVID-19, without ever being exposed to the disease itself.

This CRISPR technique effectively skips the step in traditional vaccines of introducing a version of the virus to effectively stimulate the development of an antibody. If the platform, rather than a specific vaccine, can receive authorization, it will allow companies to respond to viral outbreaks in a matter of months, as opposed to years, by simply engineering the appropriate B cells to respond to the viral threat.

The major drawback from this approach is that in the limited studies conducted thus far, it has only offered protection for a very short period of time.

Our increased understanding of genes has given rise to a new class of vaccine known as mRNA vaccines. The concept has become increasingly popular over the last few years, especially during COVID-19, and is the basis of CureVacs approach. The vaccines work by triggering cells to develop antibodies to a specific virus, e.g. SARS-CoV-2,without needing to introduce the virus itself.

Finally, beyond vaccination, there are plenty of other potential uses of CRISPR to combat COVID-19 and viral pandemics in the future. A recent Stanford study used CRISPR to directly target COVID-19 virus (SARS-CoV-2) and disable disease at an RNA level.

Beyond the current pandemic, CRISPR has potential applications to combat other viruses that humanity has been struggling with, ranging from the seasonal flu to HIV. Currently, influenza vaccinations are developed based on hypothesizing about next years viral strain. Due to the manufacturing process, companies cannot quickly respond to a change in the external environment. However, CRISPR introduces a more agile and cheaper manufacturing process, either by improving and reducing the incubation process or aiming to leverage the human body to produce its own antibodies,

Policy has already begun to respond to the potential implications of gene editing as part of a healthcare systems pandemic response mechanism. In a bold step, suggesting a softening of European Union regulations, the European Parliament and Council of the European Union adopted a regulation introducing a temporary derogation to the GMO regulation for clinical trials on vaccines for COVID-19 utilizing gene editing technologies.

This decision could have wider implications for the future use of gene editing for therapeutic use in the EU, especially as the EU looks to review its pharmaceutical strategy for the coming years, where personalized and gene therapies will be a significant component.

COVID-19 has brought the potential of CRISPR-based therapies to combat viral infections further to the foreground and encouraged research in the field. COVID-19 has also played an important role in helping to demystify gene editing to a broader audience. These developments are surely to lead to increased interest and investment in gene editing as a therapeutic solution or manufacturing mechanism outside of the rare and genetic disease space.

The EUs decision to provide an exemption to the GMO regulation could be the first step in a renewed understanding of CRISPR, or it could lead to political backlash. The coming months and years are likely to shape the future of CRISPR and gene editing as a therapeutic solution.

Excerpt from:
Could CRISPR Create a COVID-19 Vaccine? BRINK News and Insights on Global Risk - BRINK

Recommendation and review posted by Bethany Smith

One of the major challenges facing gene therapy a way to treat disease by replacing a patients defective genes with healthy ones is that it is difficult to safely deliver therapeutic genes to patients without the immune system destroying the gene, and the vehicle carrying it, which can trigger life-threatening widespread inflammation.

Three decades ago researchers thought that gene therapy would be the ultimate treatment for genetically inherited diseases like hemophilia, sickle cell anemia and genetic diseases of metabolism. But the technology couldnt dodge the immune response.

Since then, researchers have been looking for ways to perfect the technology and control immune responses to the gene or the vehicle. However, many of the strategies tested so far have not been completely successful in overcoming this hurdle.

Drugs that suppress the whole immune system, such as steroids, have been used to dampen the immune response when administering gene therapy. But its difficult to control when and where steroids work in the body, and they create unwanted side effects. My colleague Mo Ebrahimkhani and I wanted to tackle gene therapy with immune-suppressing tools that were easier to control.

I am a medical doctor and synthetic biologist interested in gene therapy because six years ago my father was diagnosed with pancreatic cancer. Pancreatic cancer is one of the deadliest forms of cancer, and the current available therapeutics usually fail to save patients. As a result, novel treatments such as gene therapy might be the only hope.

Yet, many gene therapies fail because patients either already have pre-existing immunity to the vehicle used to introduce the gene or develop one in the course of therapy. This problem has plagued the field for decades, preventing the widespread application of the technology.

Traditionally scientists use viruses from which dangerous disease-causing genes have been removed as vehicles to transport new genes to specific organs. These genes then produce a product that can compensate for the faulty genes that are inherited genetically. This is how gene therapy works.

Though there have been examples showing that gene therapy was helpful in some genetic diseases, they are still not perfect. Sometimes, a faulty gene is so big that you cant simply fit the healthy replacement in the viruses commonly used in gene therapy.

Another problem is that when the immune system sees a virus, it assumes that it is a disease-causing pathogen and launches an attack to fight it off by producing antibodies and immune response just as happens when people catch any other infectious viruses, like SARS-CoV-2 or the common cold.

Recently, though, with the rise of a gene editing technology called CRISPR, scientists can do gene therapy differently.

CRISPR can be used in many ways. In its primary role, it acts like a genetic surgeon with a sharp scalpel, enabling scientists to find a genetic defect and correct it within the native genome in desired cells of the organism. It can also repair more than one gene at a time.

Scientists can also use CRISPR to turn off a gene for a short period of time and then turn it back on, or vice versa, without permanently changing the letters of DNA that makes up or genome. This means that researchers like me can leverage CRISPR technology to revolutionise gene therapies in the coming decades.

But to use CRISPR for either of these functions, it still needs to be packaged into a virus to get it into the body. So some challenges, such as preventing the immune response to the gene therapy viruses, still need to be solved for CRISPR-based gene therapies.

Being trained as a synthetic biologist, I teamed up with Ebrahimkhani to use CRISPR to test whether we could shut down a gene that is responsible for immune response that destroys the gene therapy viruses. Then we investigated whether lowering the activity of the gene, and dulling the immune response, would allow the gene therapy viruses to be more effective.

CRISPR can precisely remove even single units of DNA. KEITH CHAMBERS/SCIENCE PHOTO LIBRARY/Getty Images

A gene called Myd88 is a key gene in the immune system and controls the response to bacteria and viruses, including the common gene therapy viruses. We decided to temporarily turn off this gene in the whole body of lab animals.

We injected animals with a collection of the CRISPR molecules that targeted the Myd88 gene and looked to see whether this reduced the quantity of antibodies that were produced to specifically fight our gene therapy viruses. We were excited to see that the animals that received our treatment using CRISPR produced less antibody against the virus.

This prompted us to ask what happens if we give the animal a second dose of the gene therapy virus. Usually the immune response against a gene therapy virus prevents the therapy from being administered multiple times. Thats because after the first dose, the immune system has seen the virus, and on the second dose, antibodies swiftly attack and destroy the virus before it can deliver its cargo.

We saw that animals receiving more than one dose did not show an increase in antibodies against the virus. And, in some cases, the effect of gene therapy improved compared with the animals in which we had not paused the Myd88 gene.

We also did a number of other experiments that proved that tweaking the Myd88 gene can be useful in fighting off other sources of inflammation. That could be useful in diseases like sepsis and even COVID-19.

While we are now beginning to improve this strategy in terms of controlling the activity of the Myd88 gene. Our results, now published in Nature Cell Biology,provide a path forward to program our immune system during gene therapies and other inflammatory responses using the CRISPR technology.

Samira Kiani, Associate Professor of Pathology, University of Pittsburgh

This article is republished from The Conversation under a Creative Commons license. Read the original article.

See original here:
CRISPR Can Help Combat the Troubling Immune Response Against Gene Therapy - Gizmodo Australia

Recommendation and review posted by Bethany Smith

Korro Bio has got off a meaty series A funding round, nabbing $91.5 million to run its platform of single-base RNA edits to treat a range of diseases.

The Cambridge, Massachusetts-based biotech will use the cash haul toward getting its preclinical program into the clinic, while also establishing a broad portfolio of innovative RNA editing therapies.

The financing was led by Wu Capital with help from current investors Atlas Venture and New Enterprise Associates. Additional new investors include Qiming Venture Partners USA, Surveyor Capital (a Citadel company), Cormorant Asset Management, MP Healthcare Venture Management and Alexandria Venture Investments.

Accelerate Clinical Operations Across Sponsors, CROs, and Partners

The most advanced life sciences organizations know that digital innovation and multi-platform integrations are essential for enabling product development. New platforms are providing the life sciences industry with an opportunity to improve the efficiency of clinical trials and reduce costs while remaining compliant and reducing risk.

Korro's platform, known as OPERA (Oligonucleotide Promoted Editing of RNA), harnesses the bodys natural base editing system.

OPERA can repair disease-causing mutations at the RNA level, in addition to creating therapeutically beneficial versions of proteins to improve patient outcomes, the biotech said in a statement. This method is based upon the work of Josh Rosenthal, Ph.D., of the Marine Biological Laboratory in Massachusetts, an affiliate of the University of Chicago.

The company, launched last year, is helmed by Nessan Bermingham, Ph.D., who three years back, handed the reins of gene editing biotech Intellia Therapeutics over to John Leonard, M.D., the R&D chief who had built the company alongside him.

After a break, he landed at Atlas Venture, the VC firm that helped launch Intellia in 2014 and that debuted Korro Bio, Berminghams latest project, last year.

Korros approach relies on nucleotide deamination, an endogenous RNA-modifying process that already happens in cells. Specifically, it takes advantage of a family of RNA-editing enzymes called adenosine deaminases acting on RNA (ADARs).

This group of enzymes deaminates the nucleotide adenosine to make inosine, which is read as guanosine (G) inside cells.

Korros ADAR approach doesnt permanently edit the genome by making a double-stranded cut in the DNA, like CRISPR systems do. With CRISPR-Cas9 systems, the delivery vehicle has to carry the actual gene-cutting mechanism. With Korros approach, that RNA-editing protein is already in the cell.

Korro is still not disclosing indications, but Duchenne muscular dystrophy and Parkinsons disease are two areas in which G-to-A mutations play a role.

This technology holds tremendous potential to usher in a new era of RNA editing therapies, said Bermingham.

We are leveraging a natural cellular system that has evolved over millions of years to base edit RNA. By co-opting these endogenous enzymes, we can create highly targeted, titratable and reversible therapeutics that are straightforward to design, manufacture and deliver. We are grateful for the continued support of our existing investors and look forward to working with our new investors to advance a new generation of transformational therapies to the clinic.

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Korro Bio hits the high notes with $91.5M series A to run its OPERA RNA platform - FierceBiotech

Recommendation and review posted by Bethany Smith

Though it is a member of the European Union, Finland has long avoided becoming entangled in the Wests military alliances, such as NATOa choice informed both by history and by the porous 830-mile-long border the country shares with Russia. This deliberate nonalignment has made the Finnish president someone pretty unique: a world leader whos well received in both Moscow and Washington.

Meanwhile, as the coronavirus continues to wreak havoc around the globe, theres good reason to fear that the next viral pandemic could be genetically engineered by humans, perhaps even using amateur tools purchased on Amazon.

And a checklist of all the ways U.S. President Donald Trump is maneuvering his way into autocracy, so you can keep track of his abuses in real time.

Here are Foreign Policys top weekend reads.

Much of the world has been captivated by Finlands young, female prime minister and her swift response to the coronavirus pandemic. But Finlands ceremonial president, Sauli Niinistoa cool-headed realistmay prove the more effective geopolitical asset, Gordon F. Sander writes.

Developed only a few years ago, CRISPR gene-editing technology is so user-friendly and accessible that scientific feats once plausible only in secretive government laboratories have quickly become kitchen table ubiquities. But this sort of democratization could doom us all, Vivek Wadhwa writes.

When Donald Trump was elected U.S. president in 2016, optimists suggested his authoritarian impulses would be reined in by the norms and seasoned Washingtonians around him. Four years later, these prognoses have proved pathetically naive, Stephen M. Walt writes.

The cool, blue Eastern Mediterranean has become heated with tension in recent months, as Greece, Turkey, and Cyprus vie for natural gas riches. The only way to prevent a full-scale conflict? Introduce a moratorium on drilling, which could save the peaceand, conveniently, the climate, tooPaul Hockenos writes.

Many of Chinas regional foes have grown comfortable with Trumps tough approach toward Chinese President Xi Jinping. Now, officials in capitals across Asia are privately voicing concern about the potential geostrategic consequences of a more Beijing-balanced Biden presidency, James Crabtree writes.

See original here:
Finland's President Can Hold His Own With Both Putin and Trump, and Other Top Weekend Reads - Foreign Policy

Recommendation and review posted by Bethany Smith

The Supreme Court has blocked the Nebraska Medical Bill Initiative from making it to the November ballots of 2020. This was done following a legal challenge filed by the Sheriff of Lancaster County, Nebraska, Terry Wagner.

Sheriff Terry Wagner had implied that the legalization proposal had violated the states single-subject rule required for ballot initiatives. Under this rule, any voter initiative or proposed legislative change cannot contain more than one focal point for voters approval.

According to attorneys of the plaintiff, the initiative is making provisions for a number of issues, which automatically disqualifies it from contesting for the ballots.

The initiative includes provisions on patient access, retail and distribution of medical marijuana, which expands the number of subjects to almost eight. This number is patently well beyond the legal limit implied by the single-subject rule of the Nebraskan legislation.

Although the state had rejected this opposition by Sheriff Terry Wagner, the Supreme Court has announced its verdict in favor of this dissent. If voters are to intelligently adopt a State policy with regard to medicinal cannabis use, they must first be allowed to decide that issue alone, unencumbered by other subjects, the justices wrote.

The Nebraska Medical Marijuana Initiative had proposed a number of constitutional amendments for the state.

Under the provisions, the purchase and use of medical marijuana usage for adults 18 years or older was to become legal. Patients below this age could still gain access to the drug by approval from licensed physicians or nurses. Legal guardians or parents of underage minor patients could also administer the drug to them after the physicians permission.

In addition to this, the bill had also proposed state legislatures to pass laws that would ensure safety of medical marijuana users. Laws for ensuring compliance with the legislation were also proposed to be devised by regulatory bodies.

Before getting challenged in the Supreme court, the bill had secured about 200,000 signatures for getting listed in the November ballots. This amount was well beyond the 121,699 signatures that were required to qualify it for the initiative.

It is important to note that these signatures were collected amidst the coronavirus pandemic. This signature drive included a truly impressive feat of grassroots mobilization. We would not have crossed the finish line without the tireless efforts of advocates, patients, families, volunteers, and hardworking Nebraskans who believe in this cause, said Senator Anna Wishart after resuming the signature collection drive which was halted temporarily due to the pandemic.

States like Oklahoma had to stop their legalization petitions midway due to a difficulty in gathering enough signatures. By crossing this huge obstruction, Nebraskans had surely proven their enthusiasm for the approval of the bill.

A marijuana advocacy group named Nebraskans for Medical Marijuana expressed disappointment at the removal of the initiative from the ballot.

Senator Adam Morfeld and Anna Wishart were also among those who were dismayed by the Supreme Courts verdict. But the duo still expressed commitment to their cause by stating a come back with new legislation and provisions.

Supporters of Nebraska Medical Bill Initiative argued that with this ruling of the Supreme Court, medical marijuana patients will suffer. They will be classified as criminals under current laws as a consequence of consuming marijuana to get relief from their respective ailments.

Governor Pete Ricketts has never shied away from expressing his opposition towards marijuana reforms.In January, he addressed Nebraskans in an article and detailed the drawbacks of the drug.

Listing the social costs of marijuana legalization, he had expressed concerns for the safety and well-being of the people. As Governor, I have a duty to promote public safety. I want Nebraskans to be informed of the dangers of marijuana and to know where I stand on the issue, he wrote.

Smart Approaches to Marijuana has their affiliate in Nebraska. The national anti-legalization group congratulated their counterpart on the Supreme Courts verdict. President of SAM, Kevin Sabet is in favor of a cannabis research bill calle HR 3797.

According to him, legalization of medical marijuana should wait before there is enough research to back its benefits. He believes that medicine should be kept away from politics and voting.

Go here to read the rest:
Gene Editing Tool CRISPR Used To Modify Cannabis Seeds - Cannabis Health Insider

Recommendation and review posted by Bethany Smith

CRISPR-Cas9 has taken the world by storm with the promise of making gene editing much easier and faster than ever before. But how does CRISPR actually work? How can biology research benefit from it? What will happen when we start using it to edit human DNA? And whats the fight between its developers all about?

CRISPR-Cas9 is one of the biggest discoveries of the 21st century. Since it was developed in 2012, this gene editing tool has revolutionized biology research, making it easier to study disease and faster to discover drugs. The technology is also significantly impacting the development of crops, foods, and industrial fermentation processes.

But the one application that has made it famous is the modification of the human genome, which brings the promise of using CRISPR to cure disease. The first clinical trials testing CRISPR-Cas9 in people are already underway in China, Europe, and the US. So while scientists start venturing into tweaking our own DNA, it is worth taking the time to fully understand what CRISPR is, and what the actual benefits and risks of using the technology are.

CRISPR is short for clustered regularly interspaced short palindromic repeats. The term makes reference to a series of repetitive patterns in the DNA of bacteria and archaea that were discovered by Spanish scientist Francis Mojica in the 90s.

These patterns are the basis of a primitive immune system that bacteria use to remember the DNA of viral invaders by incorporating the DNA sequence of the virus within the CRISPR patterns. The Cas9 protein is then able to recognize the DNA sequence stored within CRISPR patterns and cut any DNA molecules with a matching sequence.

But it wasnt until 2012 that Jennifer Doudna and Emmanuelle Charpentier at the University of California, Berkeley in the US took the discovery a step further. They published a scientific paper showing what happened when the CRISPR-Cas9 system was taken out of bacteria and introduced in eukaryotic cells the ones that make up plants or animals.

When you cut the DNA of a bacterium, you kill it. But in eukaryotes, when you cut DNA you activate a repair mechanism that opens the possibility to rewrite DNA, Mojica told me. Jennifer and Emmanuelle did it in vitro and it worked wonderfully.

Another two papers published just a few months later by Feng Zhang and George Church from the Broad Institute also reported some early uses of CRISPR as a gene editing tool.

It is important to note that CRISPR is by far not the first system that allows us to edit DNA in all sorts of organisms. Other technologies used extensively before are TALEN and zinc-finger nucleases (ZFNs). In fact, some experts point out that these tools, which have been in use enough time to become quite refined, are more accurate than CRISPR-Cas9.

But CRISPR brings an important advantage over these other techniques: it is much easier and faster to use. Most previous technologies required creating a gene editing protein from scratch for each specific DNA modification. With CRISPR, the same Cas9 molecule can be directed to any sequence just by providing it with a guide RNA molecule, which is much easier to synthesize. Companies like Synthego in the US have spotted a good business opportunity producing these guide molecules for researchers.

In theory, CRISPR gene editing could be used to make any modification to the DNA of virtually any living being. In biotech and pharma companies, CRISPR is becoming the go-to tool for drug discovery. In academic research labs, the gene editing tool is being used to modify the genome of all sorts of organisms to study the function of any gene of interest, whether it is one that causes disease or one that makes a crop grow faster or survive harsh conditions.

In agriculture, CRISPR could be used to produce crops with better yields or that resist drought, much faster than is possible with traditional breeding techniques. It can also be used to add new features, such as making tomatoes spicy, or remove others for example making gluten-free wheat or decaf coffee beans.

However, regulations can limit the use of these technologies. While the US has already seen the launch of CRISPR-modified crops, the European Union decided to set strict GMO regulations that scientists believe are hindering the potential of the technology.

But right now, most of the money seems to be in using CRISPR-Cas9 to engineer human DNA. With over 10,000 diseases caused by mutations in a single human gene, CRISPR offers hope to cure all of them by repairing any genetic error behind them.

There are two main approaches to using CRISPR as a therapy. The first is called ex vivo gene editing. It involves extracting human cells, engineering them in the lab, and reinjecting them into the patient. This method is similar to that used for most gene therapies already on the market. However, it can become quite expensive given each patient requires an individual manufacturing process for their therapy.

The second method is called in vivo gene editing and involves delivering CRISPR-Cas9 into the patients body to edit the DNA directly from within the cells. CRISPR could be delivered inside nanoparticles or encoded into DNA and be cleared out of the body once it has completed its mission. This method has only started human testing in 2020, and there are some concerns that there is a risk of CRISPR making off-target modifications.

Those are the big questions right now. Especially after CRISPR gene editing was controversially used to create the worlds first gene-edited babies in 2018. These CRISPR babies carry a mutation intended to protect them against HIV infection. The experiment resulted in a strong pushback as scientists around the world questioned the ethics of altering human DNA without fully understanding the possible consequences. Indeed, there was a study suggesting that people carrying these mutations might be at risk of catching certain infections and dying younger.

Despite all the controversy around CRISPR therapy and the large amounts of money invested in it, we are still in the very early stages of clinical trials. Scientists are wary of repeating the same mistakes as when gene therapy was first tested in humans back in the 90s, resulting in the death of 18-year old Jesse Gelsinger and causing years of delay in the development of gene therapy.

Now, even if CRISPR proves to be safe in humans, is it ethical to modify the human genome? The first applications of the technology, aimed at curing genetic diseases, seem quite straightforward. But where should the line be drawn? At what point does a therapy become a tool for eugenics?

Although the point in time when we are able to modify all sorts of human features at will is far ahead in the future, it is never too early to start thinking about how the technology should be regulated. Many scientists, including Jennifer Doudna, seem to agree that we should stay away from germline editing that is, any modifications that children will inherit. At least for now.

Since the first publications showcasing CRISPR-Cas9 as a gene editing tool back in 2012, a number of companies have been set up by the developers of the technology. Based in Switzerland and the US, there is CRISPR Therapeutics, co-founded by Emmanuelle Charpentier. Working in partnership with Vertex Pharmaceuticals, the company already has preliminary results showing promise for the treatment of the blood disorders -thalassemia and sickle cell disease. The company is using an ex vivo approach where the bone marrow stem cells of the patient are genetically engineered outside the body.

In the US, the first CRISPR clinical trial started in early 2019, run by scientists at the University of Pennsylvania. On top of academic efforts, the US counts also with the firm Intellia Therapeutics, co-founded by Jennifer Doudna; its first target will be an in vivo treatment for a rare neurological disease called transthyretin amyloidosis.

Founded by Doudna and Charpentiers competitor Feng Zhang, there is also Editas Medicine, working in therapies for genetic blindness and cancer, among others. Doudna originally co-founded Editas along with Zhang, but stopped all involvement with it just a few weeks after Zhang was granted his CRISPR patent and issues concerning intellectual property began to appear.

The intellectual property in this space is pretty complex, to put it nicely, said Rodger Novak, co-founder and previous CEO of CRISPR Therapeutics. Everyone knows there are conflicting claims.

The team of Doudna and Charpentier at UC Berkeley filed a first patent application for CRISPR in May 2012, a few months before their paper was published. Zhang and the Broad Institute filed theirs in December that year, but they paid the US patent office to fast-track the review process. This resulted in Zhangs patents being issued before there was a decision on his competitors.

UC Berkeley then initiated a process to invalidate the Broads patent on the basis that Doudna and Charpentier had developed the technology and applied for a CRISPR patent earlier. The US patent office ended up ruling in favor of the Broad Institute, after both parties combined had already spent over $20M (16M) in legal fees.

It reminds me of reading about really unhappy rich people, said George Church about the patent fight. They have such a big blank check that they just make each other miserable.

Everything here is very exaggerated because this is one of those unique cases of a technology that people can really pick up easily, and its changing researchers lives. Things are happening fast, maybe a bit too fast, commented Charpentier. I am very confident that the future will clarify the situation. And I would like to believe the story is going to end up well.

Indeed, the situation is quite favorable for Charpentier and Doudna across the Atlantic. In Europe, they have secured broad patents on CRISPR while the Broad Institute saw its patents revoked earlier this year. While the Broad can still enforce its intellectual property in Europe with narrower claims, its licensing and royalty fees may be lower.

The situation is paralyzing small companies. They are afraid of being held liable for patent infringement so theyd rather not use the technology, said Ulrich Storz, Senior Partner at Michalski Htterman Patent Attorneys. This situation is not very common in biotech. We werent prepared, and thats why there have been so many problems with this technology, with this patent challenge.

With its potential already demonstrated in research applications, the next big milestone for CRISPR will be proving to be safe and effective as a treatment. But there are still many other applications underway.

For example, the US company eGenesis, co-founded by George Church, is using CRISPR to modify the pig genome so that their organs can be transplanted into humans without rejection. Another is the use of CRISPR as a diagnostics tool; some researchers have already developed a method to detect Covid-19 using CRISPR.

CRISPR might still surprise us as new variants are developed. Swiss scientists have developed a method to simultaneously edit up to 25 genes using CRISPR. And another version of the gene editing tool called CRISPR-Cpf1 that makes it easier to replace one DNA sequence by another is already being used by big brands such as BASF. You can imagine that many labs including our own are busily looking at other variants and how they work, Doudna said. So stay tuned.

The gene editing tool is also becoming very popular between DIY scientists and biohackers. Some believe that the relatively simple methods that this technique requires might help democratize science and bring it closer to people outside the lab. However, some cases of biohackers injecting themselves with experimental treatments have alarmed the public and it remains to be seen how these uses will be regulated.

In any case, the impact of CRISPR in biology is already tangible and will undoubtedly go down in history as a big discovery. The cherry on the cake will come when the technology wins the Nobel prize, which many have been unsuccessfully predicting will go to CRISPR for years.

It is possible they are waiting for CRISPR to demonstrate all the potential that is expected, but it would be unfair, CRISPR discoverer Francis Mojica told me. What CRISPR has already achieved is much more than what other tools that have received the Nobel have achieved. The prize has gone to tools used to cut and copy DNA in the test tube. CRISPR can be used to edit genomes, change expression levels, visualize DNA, kill bacteria, develop diagnostics, and many more applications, even to store a movie within DNA.

I am convinced it will get it. When? I dont know.

Images via Soleil Nordic /Shutterstock; The Conversation; Knaw /Flickr CC2.0; Science

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Around 20% of ovarian cancer cases occur as a result of an inherited genetic mutation, which, according to experts, highlights the need to identify individuals for whom targeted therapy or ovarian cancer risk-reducing interventions may be beneficial.

Knowledge of cancer genetics in this population is an important topic because more than 20% of ovarian cancer cases are associated with an inherited pathogenic variant, said Rachel Pozzar, a post-doctoral research fellow at Dana-Farber Cancer Institute in Boston. From prior research, we know that individuals who are confident in their knowledge of cancer genetics are more likely to share their genetic test results with relatives. In turn, these relatives may benefit from genetic testing and certain risk-reducing interventions.

Together with her colleagues, Pozzar, who holds a post doctorate degree in nursing science, conducted a secondary analysis of a cross-sectional survey to better understand knowledge of cancer genetics among individuals with a primary diagnosis of ovarian cancer. The results of this analysis were presented at the 2020 ONS Bridge Virtual Meeting.

Patients were eligible for this analysis if they had a primary diagnosis of ovarian cancer and received genetic counseling and testing between January 2016 and October 2017. Using the KnowGene scale, Pozzar and colleagues assessed patients cancer genetics knowledge. Patients were also asked open-ended survey questions to help the researchers identify ways to improve the genetic testing and counseling process.

Eighty-six patients were included in this analysis. Their mean age was 65.8 years. Out of a possible score of 19, the mean knowledge score of the patients was 11.9. The data also demonstrated that a patients age, income and education were significantly associated with knowledge of genetic testing. Patients who were younger and patients who had a higher education were more likely to have an increased knowledge of cancer genetics, according to results of multivariate analyses.

Responses from the open-ended survey showed that patients found it challenging to relate to complex language in verbal and written explanations of genetic test results.

One of our main findings was that participants who scored below the sample average on our measure of cancer genetics knowledge expressed interest in face-to-face results disclosure, visual learning aids, and simplified language in written and verbal communication, said Pozzar. We also found that older age was significantly associated with lower cancer genetics knowledge, which is important because older adults may serve as a resource for family members who seek information about their family's health history.

Pozzar notes that the results of the study emphasize the importance of patient-provider communication when discussing cancer genetics.

My broader program of research is focused on promoting patient-provider communication that meets patients unique needs and preferences what is often called patient-centered communication, Pozzar concluded. Research suggests patient-centered communication has the potential to promote knowledge retention and to prompt family conversations about hereditary cancer risk.

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New billing rules from UnitedHealthcare have the lab industry concerned about additional administrative burdens and the potential for an increase in denials from the nation's largest health insurer.

At the beginning of March, the payor began rolling out notices of its new test registry protocol, under which labs must register with UHC the tests they offer and include a unique test code for each test they bill the insurer in order to be reimbursed.

UHC declined an interview request but provided comments on the test registry rollout through a spokesperson. The company initially set a deadline of September 1, 2020 for labs to register their tests but recently extended that deadline to December 1, 2020 due to the SARS-CoV-2 pandemic, said the spokesperson. Regarding the new deadline the company "will continue to monitor the situation and make adjustments as needed," UHC said.

Even with the new deadline, though, many labs, especially smaller independent labs and hospital outreach facilities, may struggle to register their tests in time, said Jane Hermansen, manager of outreach and network development at Mayo Clinic Laboratories and the immediate past president of the Clinical Laboratory Management Association.

"Hospital labs are really stressed and are quite panicky about finding the time to fit this extra administrative step in," said Hermansen, noting that the timing is particularly challenging given the pandemic situation. "We are still dealing with hunkering down, getting ready for a third wave of sick patients to come in this fall, and now we have to take an overburdened systems and add this IT data entry piece, as well."

UHC said that the company has created the test registry in order to gain better visibility into what tests it is paying for and to provide its members better information on test availability and costs.

Kyle Fetter, executive vice president and general manager of diagnostic services at Xifin, said, however, that while this might make sense for some categories of testing, the value of applying the requirement across the board including to very routine tests was less clear.

Fetter said that the genetic testing space had gone through a similar experience in the last decade. At that time, he noted, "you had many types of genetic tests that were different from each other in many ways and unidentifiable based on the codes that they were using."

In that case, Fetter said, the Molecular Diagnostic Services (MolDX) program determined that the CPT codes being used for these tests were not sufficient and that other, more descriptive identifiers were needed.

"And that was OK on some level because there were probably some tests out there getting paid for that maybe in hindsight should have had more oversight," he said.

Fetter said the UHC registry is different in that the payor is requiring registration not only of complex tests for which more descriptive codes could provide useful transparency, but of "all laboratory testing, even the most generic laboratory testing."

One possible motive for UHC, Fetter said, is that the test registry could make it easier for the payor to identify bills from out-of-network labs.

"The fact that you have to give this additional code gives them a very discrete and easy mechanism to identify an out-of-network service," he said. "People think things like that are easy for a payor like, yeah, I know when I see this lab come in on a claim with this procedure, it is out of network but it's not easy. Adding another code like this does probably make this quite a bit easier for them in their adjudication systems to identify services as out of network."

Fetter also suggested that the move was a way for UHC to narrow its network by creating a burden that may be challenging for many labs to meet.

Harley Ross, executive vice president and chief revenue officer at healthcare revenue cycle management firm Quadax, suggested that the registry could potentially help UHC steer more business to its Preferred Lab Network members, which are mostly large national labs with IT infrastructure and resources that could make it easier for them to comply with the requirements.

This would fit with other moves by the insurer that seem designed to steer patients to these preferred providers, which typically have lower prices than small independent or hospital labs.

For instance, UHC has eliminated out-of-pocket charges for many of its members when they use a PLN member for their lab testing, which may incentivize members to use PLN labs, particularly in cases where they would otherwise be subject to substantial cost sharing or co-pays.

Ross said that the implementation process and the inevitable hiccups involved from an operational perspective could prove too much for some more financially vulnerable labs.

"These things never go off cleanly," he said. "So, from an operational cost perspective, if all of a sudden my costs on, for example, UnitedHealthcare claims go up 10 percent because I'm having to do contract denial follow-up, appeal follow-up, etc. there are just a lot of unknowns about how material that will be to those labs."

He suggested that given UHC's size, this could have broader effects on the industry, including but not limited to, impacting reimbursement rates under the Protecting Access to Medicare Act if it resulted in labs seeing lower average test payments.

The company has received pushback from a number of provider groups regarding its test registry. In August, the American Hospital Association issued a letter to UHC calling on the payor to reconsider the policy, saying that it "could negatively impact the accessibility of care, as well as create unnecessary burdens on both patients and providers at the same time that such providers are expected to still be managing the COVID-19 public health emergency." It added that UHC has not "provided a rationale" for the requirements nor "justified the potential negative consequences."

The College of American Pathologists also issued a statement in August objecting to the registry requirements, particularly in light of the pandemic, saying that "now is not the time to move forward with new billing rules and potentially further disrupt revenues by denying claims for tests."

Fetter said that there is also frustration in the lab industry at what is perceived as a lack of communication coming from UHC.

"When we could call them about it, people couldn't answer questions about it," he said.

Hermansen said that UHC rolled out the plan with little notice.

"They just kind of snuck it out on their website, and it was just kind of savvy people who were poking around on that website and said, oh, look at this," she said.

UHC said that the company began to post information about the change on its website starting on March 1, 2020 and that it has since published articles in its network bulletin and sent letters to providers.

Beyond the UHC requirements, there is the concern that other payors will follow suit, Hermansen said.

If that happened it could be a substantial burden for labs, Fetter said. "If Humana and Aetna and Anthem and other payors all picked this up, it would be a pretty massive lift" for labs.

"You'll have 10 different codes for 10 different payors," he said. "So you send a bill to UnitedHealthcare and it's a patient who has AARP backing up an Aetna Medicare Advantage plan, and they aren't going to have the same codes when they cross those claims over."

Fetter suggested that concerns about this kind of complication might ultimately lead UHC to walk back the registry plan, at least partially.

"My guess is that even if this goes into place, they will end up having to roll it back at certain points because it won't be working," he said. "I think they are going to realize this is a bigger headache than it's worth."

He noted that UHC rolled out its genetic test registry at the end of 2019 and suggested that the broader test registry might have been conceived as a way to expand that concept to other test codes that it also considered lacking in transparency.

"I think they said, let's take this [genetic registry] a step further and roll it out to the rest of lab because there are other tests that are unnecessarily complex and expensive and we don't have good tracking on them," Fetter said.

This story first appeared in our sister publication 360Dx, which provides in-depth coverage of in vitro diagnostics and the clinical lab market.

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Labs struggling to comply with UnitedHealthcare test registry requirements - Modern Healthcare

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