Archive for the ‘Hormone Physician’ Category

Regardless of your skin tone, protecting it from the sun is important. Theres no worse way to ruin what was an amazing day at the beach than getting home and realizing youre as red as a lobster. And if you dont burn as easily (or at all), its still important to shield yourself from exposure to the suns rays since it can cause damage to your skin in other ways, including skin cancer. Thats why wearing a proper sunscreen is essential when spending time in the sun. But even if trips to the beach are getting few and far between, that doesnt mean you should stop wearing sunscreen, since you should be wearing it indoors anyway (yes, really!).

To help you find the best sunscreen, we talked to experts about the active ingredients and other important factors you should look for. We narrowed down a pool of 12 contenders and went hands-on with each of them for several weeks. Our pool included both mineral and chemical broad-spectrum sunscreens with a minimum SPF of 30. We avoided sunscreens that have oxybenzone, or either of the two active ingredients the FDA proposed as unsafe (aminobenzoic acid and trolamine salicylate).

To be clear, we didnt test how well these sunscreens protect skin from the sun we relied on information from the FDA and the experts we talked to for that (scroll down to see what they had to say). Too many variables (skin type, time of day, the suns intensity, etc) made it somewhat impossible to test efficacy in our real world testing. Rather, we had multiple testers with different skin types and tones test them for other variables such as feel, appearance on the skin, smell, ease of application and more.

After multiple weeks of testing, we found three sunscreens that stood above the rest:

The Hawaiian Tropic Island Sport Sunscreen Spray scored miles above every other sunscreen we tested. An SPF 30, broad-spectrum, chemical formulation, this spray sunscreen applied super light, rubbed into our skin right away and smelled deliciously of coconut. A locking cap and slim bottle is just icing on the cake for our top-scoring sunscreen.

Our runner-up was the Alba Botanica Very Emollient Sport Sunscreen, an SPF 45, broad-spectrum, chemical sunscreen. It had a light texture, making it incredibly easy to apply and it rubbed right into our skin without leaving any white streaks. It had a light, subtle scent and is the best option if you dont want sunscreen with a strong smell.

If you want to be extra safe and go with a mineral sunscreen (more on the differences below), the Coppertone Pure & Simple Sunscreen Lotion is the pick for you. Physical sunscreens are harder to rub in and thicker than chemical sunscreens by nature, but this lotion rubbed in much better than other mineral options and has a light feel. Its an SPF 50, broad-spectrum formulation with only zinc oxide as its active ingredient, which means its the safest pick if youre worried about chemical absorption or have sensitive skin.

With so many different active ingredients and types of sunscreens, it can be overwhelming to know what to look for. The FDA complicated matters a bit more when it proposed a new rule in February 2019 calling for more research on certain sunscreen ingredients. We are requesting additional information on these ingredients so that we can evaluate their GRASE [generally recognized as safe and effective] status in light of changed conditions, including substantially increased sunscreen usage and exposure and evolving information about the potential risks associated with these products since they were originally evaluated, the agency wrote.

The FDA also recently found that seven common sunscreen chemicals can be absorbed into your bloodstream, although theyve stated that doesnt mean you should necessarily stop using those ingredients: The fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe. One of the experts we talked to, Dr. Elisabeth G. Richard, a member of the photobiology committee at The Skin Cancer Foundation, says if people are concerned about absorption they should use physical (often called mineral) options, and, Out of an abundance of caution, pregnant and nursing women may want to consider using mineral sunscreens.

With all these new findings, choosing a safe and effective sunscreen can be a challenging task, which is why we dove deep into the research and interviewed experts to identify the best options. They all agreed that using a broad-spectrum sunscreen, which protects you from both UVA and UVB rays is critical. On top of that, you should use a product with an SPF of at least 30, which tells you how long it takes for the UV rays to hit and damage your skin. So, using an SPF 30 exactly as directed on the products packaging means it will take you 30 times longer to burn compared to not wearing any sunscreen. Its also important to find a sunscreen that has a rating for water resistance. If youre going to be swimming or sweating, look for sunscreens labeled water-resistant which are tested to be effective for up to 40 minutes of swimming, says Dr. Richard. Very water-resistant sunscreens stay effective for up to 80 minutes in the water.

Where it gets more complicated is deciding which kind of sunscreen ingredients you should use. We found that physical sunscreens are your safest bet for protection, as none of the ingredients absorb into your bloodstream. Mineral sunscreens contain zinc oxide, titanium dioxide or both, but they are normally thicker, whiter and dont disappear as well into your skin like their chemical counterparts. Mineral sunscreens work by physically blocking the rays of the sun so they dont reach your skin. Chemical sunscreens, on the other hand, work by absorbing the rays so your skin doesnt have to.

In the world of chemical sunscreens, there are two active ingredients you should definitely avoid: aminobenzoic acid (PABA) and trolamine salicylate. In 2019, the FDA proposed that these do not meet the standards safe and effective for sunscreen use.

The FDA still wants more safety information on 12 other chemical sunscreen ingredients, but there are some studies about one ingredient in particular, oxybenzone, that have discovered a potential link between the chemical and lower testosterone levels, hormone changes in men and shorter pregnancies and disrupted birth weights in babies. However, according to CNN Health, experts caution about assuming an association between exposure and those outcomes. Its one of the seven active ingredients that was found to absorb into your bloodstream, and Hawaii, Key West and the Pacific nation of Palau have banned sunscreens containing oxybenzone because of its impact on coral reefs. To be extra cautious, we didnt include any sunscreens that contain oxybenzone in our tests.

Hawaiian Tropic Island Sport Sunscreen Spray

The Hawaiian Tropic Island Sport Sunscreen Spray achieved a perfect score in nearly every single one of our tests. Its spray function made it extremely easy to apply, and it has a wide and even distribution, making it easy to quickly cover your entire body with a swift pass; it clocked in with the fastest full-body application for the testers who examined it.

The spray disappeared nearly immediately into our skin and didnt leave any lingering color or sheen. It felt a little wet at first but soon absorbed into our skin and we completely forgot wed even applied it. The sprays tropical smell of coconuts was pleasant, though it has a hint of chemicals and is quite strong overall, which could deter people with more sensitive senses of smell.

In addition to being a quick and easy sunscreen to apply, the Hawaiian Tropic Island Sport Sunscreen comes in a slim container that barely takes up any room in a bag, plus it can easily fit in a standard water bottle pouch on the side of a backpack. The cap twists into a lock position, so wherever you store it, you can be sure it wont leak or soak any of your belongings.

The Hawaiian Tropic Island Sport Sunscreen Spray will keep you safe from the sun with its expert-approved, broad-spectrum SPF 30 formulation. Its water- and sweat-resistant for 80 minutes, and is made without the dangerous chemical ingredients that the FDA and other studies have warned us to avoid. Its incredibly easy to apply and its smell, feel on our skin and lack of streaking places it solidly as our pick for best overall sunscreen.

Alba Botanica Very Emollient Sport Sunscreen

If you dont want a spray or if you have a sensitive sense of smell, then the Alba Botanica Very Emollient Sport Sunscreen is the pick for you. It scored remarkably high in our testing, a few points below our overall winner, just beating out the cult-favorite Sun Bum sunscreen (which we also loved; scroll down to read about other sunscreens we tested). The chemical sunscreen shone brightest in its ease of application and ability to disappear right into our skin. Its light texture rubbed in quickly, and one of our testers even said it left her skin looking glowy.

The Alba sunscreen is marketed as fragrance-free, which rings mostly true as both our testers loved its light and subtle scent. The only dings really came with the sunscreens feel, as it was a little thick and left a chalky feeling on one of our testers fingers after application.

Albas sunscreen comes in a small, compact bottle so you can easily stash it in any bag. The cap snaps shut, and while it doesnt have a locking mechanism, its quite secure and shouldnt leak.

The Alba Botanica Very Emollient Sport Sunscreens broad-spectrum, SPF 45 lotion met all of the experts standards for offering stellar sun protection, while avoiding the harsh chemicals the FDA has proposed as unsafe. If youre looking for a sunscreen lotion that goes on fast or an option with little to no scent, we think the Alba Botanica Very Emollient Sport Sunscreen is the best one to keep you covered.

Coppertone Pure & Simple Sunscreen Lotion

If you want to be extra safe and completely avoid chemical active ingredients, a mineral sunscreen is the way to go, according to the experts we spoke to. While this variety is generally thicker and harder to rub in than a chemical sunscreen, out of all the mineral options we tested, the Coppertone Pure & Simple Sunscreen Lotion stood out above the rest.

Albas Botanica Fragrance Free Sensitive Mineral Sunscreen fell short of our best mineral sunscreen spot because it was harder to rub in than the Coppertone, but the Alba mineral sunscreen does come in a spray bottle, which might be a plus for some.

The Coppertone formula is an SPF 50, broad-spectrum lotion with only one active ingredient: zinc oxide. The Coppertone excelled in tests where mineral options normally fell short, namely in ease of application and sunscreen visibility. The lotion itself is thin enough that it applies smoothly to the skin. However, like all mineral sunscreens we tested, it took a while to sink in. One of our testers saw a slight but noticeable white cast on her skin after applying, while another said it took some rubbing but most of the chalkiness and color eventually disappeared.

This sunscreen didnt have much of a smell, though our testers did pick up a slight chalky, mineral scent. The Coppertone felt gentle on our skin, with no issues or irritation, which makes it a go-to option for anyone with sensitive skin, including children.

If you want to avoid chemical sunscreens altogether, there are plenty of mineral options out there. Many of them take more time to apply and might leave a white cast, but if you want a sunscreen that offers safe protection and isnt a chore to put on, you wont find one better than the Coppertone Pure & Simple Sunscreen Lotion.

While finding the perfect sunscreen that has broad-spectrum coverage and an SPF of at least 30 is critical to protecting yourself from the sun, many experts we talked to also made sure to point out that avoiding sun damage doesnt end with a good sunscreen.

While sunscreen is an important part of a sun protection strategy, it is not our only protection, says Dr. Richard. Remember that clothing, shade structures, sunglasses are all additional measures to use when protecting your skin from UV rays. And Amanda Turney, a press officer at the FDA, encourages consumers to limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the suns rays are most intense.

We selected 12 sunscreens to test after extensively researching the different types available, their active ingredients and minimum requirements for effective protection against the sun. We relied heavily on research done by the FDA and spoke to various experts who echoed and supported the conclusions of the FDA.

We only tested sunscreens that were broad-spectrum (meaning they block both UVA and UVB rays), had and SPF of 30 or above and didnt contain oxybenzone or either of the two ingredients the FDA suggested as unsafe (aminobenzoic acid commonly referred to as PABA and trolamine salicylate).

We interviewed several experts, including dermatologists, to create this criteria. Dr. David Colbert, the founder and head physician at New York Dermatology Group, said micronized zinc oxide or titanium dioxide (the two mineral sunscreen ingredients) are the best active ingredients to look for because they are inertly safe. Chemical sunblocks the super long words most people cant say or spell such as methoxycinnamate can get into the bloodstream and into the environment, he says. I prefer physical sunblocks and of course sunblock clothing and umbrellas.

The experts we talked to also praised physical sunscreens for their gentleness on skin. The physical sunscreens ingredients, zinc oxide and titanium dioxide, tend to be better tolerated by people with sensitive skin and can usually be found in sunscreens for babies and children, says Dr. Elisabeth G. Richard, a practicing dermatologist, assistant professor at John Hopkins University School of Medicine and member of the photobiology committee for The Skin Cancer Foundation. Above all, Dr. Richard says whats more important than the ingredients in your sunscreen is whether you use it. We believe the best sunscreen is the one youll use, she says. Whats most important is choosing a broad-spectrum sunscreen with an SPF of 30 or higher every day that suits your skin and activity.

We ran each sunscreen through the same set of tests to measure both performance and portability. We did not test each sunscreens ability to protect you from the suns rays, but instead relied on our extensive research and the opinions of experts we interviewed to create criteria that all the sunscreens we tested met. Our performance ratings were instead based on tests that focused on the products ease of application, visibility, smell and other variables. Since many of these tests are subjective, we had two testers evaluate each sunscreen and took the average of both results. Heres a full breakdown of every test we ran:

Performance

Portability

We rated the performance of each sunscreen as we conducted all the tests mentioned above. We gave each product a score for each test, added those up to find a score for each category and tallied those results to find an overall rating. Heres a full breakdown of our scoring system:

Hawaiian Tropic Sheer Touch Lotion Sunscreen ($10.99; target.com)

Hawaiian Tropic Sheer Touch Lotion Sunscreen

PHOTO: Target

The Hawaiian Tropic lotion sunscreen performed quite well, but not as well as its spray-bottle counterpart. It lost a few points for its ease of application and size. Overall, its a solid sunscreen that rubbed into our skin well and wasnt too thick, but its tropical, fruity smell may be overpowering to some.

Banana Boat Simply Protect Sport Reef Friendly Sunscreen Spray ($8.99; riteaid.com or $11.89 for 9.5 ounces; target.com)

Banana Boat Simply Protect Sport Reef Friendly Sunscreen Spray

PHOTO: RiteAid

This chemical sunscreen also scored very well in our testing, achieving high marks for ease of application, how it felt on our skin and visibility. One of our testers said it was a little harsh on her sensitive skin, though, and the chemical smell can be overbearing. But if you those factors arent an issue for you, this option from Banana Boat is a top-notch spray sunscreen.

Sun Bum Original SPF 30 Sunscreen Lotion ($15.99; amazon.com)

Sun Bum Original SPF 30 Sunscreen Lotion

PHOTO: Amazon

Sun Bums chemical sunscreen was one of our favorites. It has a light texture that rubs in quickly, and boy oh boy does it smell good. The creamy banana scent had us reaching for Sun Bum more than most of the other options in our test pool. It was just a few points shy of our winners because it took more time to apply than the sprays and comes in a bottle thats a bit bulky.

MDSolarSciences Mineral Moisture Defense SPF 50 ($39; amazon.com)

MDSolarSciences Mineral Moisture Defense

PHOTO: Amazon

MDSolarSciences is one of the most expensive sunscreens we tested, but it fell short of our top picks in many categories. It didnt have a discernible scent, which was nice, but it felt greasy on our skin, making us sweat more and leaving us desperately wanting a shower.

California Kids Supersensitive Broad-Spectrum Tinted Sunscreen ($25.99; amazon.com)

California Kids Supersensitive Broad-Spectrum Tinted Sunscreen

PHOTO: Amazon

The biggest issue with this mineral sunscreen from California Kids was how long it took to rub into our skin. It lacks a strong scent, which is a plus, but both our testers docked points because it left a white residue that wouldnt go away.

Thinksport Safe Sunscreen SPF 50+ ($9; amazon.com)

Thinksport Safe Sunscreen SPF 50+

PHOTO: Amazon

This sunscreen is made with the sole active ingredient of zinc oxide. It was incredibly thick and took quite a while to fully apply; even after we took a long time to thoroughly rub it into our skin, it left white streaks. Several other mineral options we tested, such as the Coppertone and Alba sunscreens, were much easier to apply.

Alba Botanica Fragrance Free Sensitive Mineral Sunscreen ($11.99, originally $15.99; amazon.com)

Alba Botanica Fragrance Free Sensitive Mineral Sunscreen

PHOTO: Amazon

This spray sunscreen from Alba was a close second to the Coppertone for our pick for best mineral sunscreen. The spray function made application a much faster process, but we still had to rub in the sunscreen a lot as it came out white and chalky.

Cerave Broad-Spectrum Sunscreen Stick ($9.99; amazon.com)

Cerave Broad-Spectrum Sunscreen Stick

PHOTO: Amazon

The Cerave Sunscreen stick is a fantastic option for a portable sunscreen you can keep in your purse, but its small size means its a pain to apply to your entire body. It scored well in our tests, almost claiming the title of best mineral sunscreen, but we ultimately chose the Coppertone Pure & Simple Sunscreen Lotion since its a better option for full-body application. The Cerave is a mineral formula and has a decent smell and feel, but where it really shined was with its petite size and ultimate portability.

Colorscience Sunforgettable Total Protection Body Shield ($45; colorscience.com)

Colorscience Sunforgettable Total Protection Body Shield

PHOTO: Colorscience

This mineral sunscreen is the most expensive on our list, but it scored lower than many other, cheaper options. It didnt feel amazing on our skin, with one tester describing it as matte and silky, but still as though there were a thick film on his skin. It had a light scent thats reminiscent of makeup, but its just too expensive compared to the other, better options we tested.

Read more from CNN Underscoreds hands-on testing:

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The best sunscreens of 2020 - CNN

Biomedical engineers at Duke University have shown that the efficacy of a two-pronged type 2 diabetes treatment increases when the drugs are linked by a heat-sensitive tether rather than simply concurrently administered. The combination molecule is formed by an elastin-like polypeptide (ELP) linker that forms a gel-like depot when injected under the skin, which slowly dissolves and releases the active drug over time.

This novel approach features the commonly prescribed type 2 diabetes drug glucagon-like peptide-1 (GLP-1) and the compelling drug candidate fibroblast growth factor 21 (FGF21) that together create tight glycemic control and potent weight-reduction in diabetic mice. Coupled with the slow-release function of the ELP, the effects last longer than one week with a single injection.

Because GLP-1, a short peptide, and FGF21, a large folded protein, are such different compounds, these findings suggest that this approach to combination drug design could be applied to disease therapies beyond diabetes.

The results appear online on August 26 in the journal Science Advances.

In the burgeoning field of multi-functioning single-molecule diabetes drug design, researchers primarily unite drugs that are similar in size, structure and function, said Caslin Gilroy, a postdoctoral scholar at the University of California, Berkeley, who led the project while completing her PhD in biomedical engineering at Duke. Being able to combine such structurally distinct drugs into a single molecule while maintaining the bioactivity and stability of each is a big technological achievement.

Type 2 diabetes is a progressive disease where body tissues become resistant to the effects of insulin, which regulates the movement of sugar from the bloodstream into cells. When this carefully tuned system breaks down, blood sugar levels remain toxically elevated and a host of serious complications can follow. While many treatment options exist, a single drug is rarely able to treat an advanced case. Conventional medications lose their potency over time and frequently cause weight gain, which itself can promote insulin resistance and exacerbate the disease.

Being able to combine such structurally distinct drugs into a single molecule while maintaining the bioactivity and stability of each is a big technological achievement. - Caslin Gilroy

A growing class of drugs is based on GLP-1, a naturally occurring peptide released from the intestines after a meal. GLP-1 therapy enhances the release of insulin from the pancreas while promoting weight loss. However, the high doses of GLP-1 that are sometimes necessary to maintain healthy blood sugar levels have been shown to cause gastrointestinal distress. Researchers are exploring combination therapies that strategically pair GLP-1 with additional drugs to maximize glucose control, minimize side effects and augment weight loss.

While most drug combinations incorporate small peptides from the same family as GLP-1, Gilroy and Ashutosh Chilkoti, the Alan L. Kaganov Distinguished Professor of Biomedical Engineering at Duke, chose to work with FGF21. A metabolic hormone, FGF21 regulates insulin sensitivity, energy expenditure and fat metabolism within body tissues.

FGF21 functions through a different mechanism than GLP-1, and we hypothesized that the two drugs would complement each other nicely, said Gilroy. GLP-1 increases insulin secretion by the pancreas, while FGF21 enhances the bodys response to the insulin. GLP-1 reduces food intake, while FGF21 helps burn more calories.

But rather than simply injecting diabetic mice with both drugs at the same time, the researchers decided to link GLP-1 and FGF21 together into a single molecule. This approach to combination therapy has several advantages. A single molecule is more predictable in how it will disperse through the body, act on its target tissues and eventually be cleared. A single drug is also beneficial for the prescribing physician and patient, as it reduces the medication burden and simplifies the treatment regimen. And the FDA approval process for a single drug is more straightforward than for a drug mixture.

GLP-1 and FGF21, however, are both peptide-based drugs, heavily reliant on shape and surface features to function. Tethering the two without interfering with either is easier said than done.

To form one drug out of two, the researchers turned to the ELPa specialty of the Chilkoti research group. ELPs are chains of repetitive peptide sequences that are highly disordered in nature. This disorder provides flexibility, enabling drugs fused at each end of the ELP the room to do their respective jobs. The modularity of ELPs also make them highly tunable, allowing for the design of the best delivery system possible.

Linking the drugs to an ELP allows us to design a compound that is liquid at room temperature but forms a gel-like depot upon injection. The depot dissolves over the course of at least a week, slowly and regularly releasing drug to the system over time. - Caslin Gilroy

Peptide-based drugs suffer from two notable disadvantages; they have a short half-life, due to rapid clearance from the body, and they must be administered by needle. An ELP-based delivery platform, however, addresses both of these issues.

Linking the drugs to an ELP allows us to design a compound that is liquid at room temperature but forms a gel-like depot upon injection, said Gilroy. The depot dissolves over the course of at least a week, slowly and regularly releasing drug to the system over time.

Chilkoti already has two Phase II clinical trials underway using ELPs as slow-release delivery systems. One trial aims to treat pulmonary arterial hypertension, while the second involves a potential therapy for COVID-19.

In the study, after verifying that GLP-1 and FGF21 retain their respective functions and potencies when linked together by an ELP, Gilroy and Chilkoti tested their multi-functioning, slow-release molecule in a mouse model of diabetes.

"We were more than pleasantly surprised when Caslin showed that combining these drugs into a single molecule clearly showed a synergistic therapeutic effect compared to a mixture of the two drugs. The data is so compelling that we believe its ready for a company to pursue this strategy commercially. Dukes Office of Licensing and Ventures is currently looking to license it. - Ashutosh Chilkoti

The results show that levels of drug circulating in the system remained steady while blood sugar levels were brought down to a healthy level and maintained for up to 10 days following a single dosing. Mice treated with the GLP-1/FGF21 combination drug were better able to recover from a glucose challenge compared to either drug alone, and were the only test group to lose weight during the trial.

The drug combination also worked better when GLP-1 and FGF21 were tethered together rather than being delivered as a mixture of individual drugs. The researchers think that linking them guarantees that GLP-1 and FGF21 are always acting in concert at the same point in time, allowing their mechanisms of action to synergize and work together.

We had speculated that we may see synergy when we combined GLP-1 and FGF-21 because they have different modes of action, said Chilkoti. That was really just a hope at the outset of this project, and we were more than pleasantly surprised when Caslin showed that combining these drugs into a single molecule clearly showed a synergistic therapeutic effect compared to a mixture of the two drugs. The data is so compelling that we believe its ready for a company to pursue this strategy commercially. Dukes Office of Licensing and Ventures is currently looking to license it.

This work was supported by Duke MEDx, a Duke University program that supports engineering innovation in medicine.

CITATION - Sustained Release of a GLP-1 and FGF21 Dual Agonist from an Injectable Depot Protects Mice from Obesity and Hyperglycemia. C.A. Gilroy, M.E. Capozzi, A.K. Varanko, J.Tong, D.A. DAlessio, J.E. Campbell, A. Chilkoti. Science Advances, Aug. 26, 2020. DOI:10.1126/sciadv.aaz9890

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Type 2 Diabetes Drugs Work Better in Tethered Combination Therapy - Duke Today

August 30, 2020

By DARLENE SUPERVILLE and DEB RIECHMANN

WASHINGTON (AP) Public health experts expressed concern Friday about President Donald Trumps largely mask-free, socially un-distanced , saying some of his 1,500 guests may have inadvertently brought and spread the coronavirus to others.

There almost certainly were individuals there who were infected with COVID-19 but dont know it, said Dr. Leana Wen, an emergency physician and public health professor at George Washington University..

I worry about these individuals infecting one another and most certainly going back to their home, said Wen, who previously served as Baltimores health commissioner.

Trump delivered his speech accepting the GOP presidential nomination at the Thursday night event, which continued a pattern of flouting coronavirus safety guidelines.

Few in the audience wore masks when virtually all leading public health professionals, including the administrations, say face coverings play a big part in slowing virus transmission.

Chairs were placed inches apart instead of the recommended 6 feet, leaving attendees little room to practice social distancing.

Only those guests the White House expected to be in close proximity to Trump and Vice President Mike Pence were to be tested for COVID-19, the disease caused by the virus.

Though public health officials have said outdoors is safer than indoors, the Centers for Disease Control and Prevention also puts where people cannot stay 6 feet apart and attendees come from out of town.

Trumps campaign issued a statement from Dr. Robert Darling, chief medical officer of Patronus Medical Corp., who said the Republican National Committees protocols are in full compliance with multiple guidelines issued by the CDC, the District of Columbia health department and other leading health authorities. He provided no details.

The campaign said Darling, a former White House physician to President Bill Clinton, has been working with the RNC to make sure the proper protocols are in place at convention sites.

In Charlotte, North Carolina, where the city required a process to be put in place to trace peoples contacts in the event of an outbreak, including requiring attendees to wear trackers on their lanyards.

Masks and social distancing requirements were also in place, and attendees were required to complete a daily temperature screening and wellness questionnaire. They were tested before departing for Charlotte and retested upon arrival.

Out of nearly 800 coronavirus tests administered, two attendees and two people supporting the Charlotte event tested positive after they arrived, the county health department said. The four individuals were instructed to isolate, and any known close contacts were notified and given instructions on quarantining, the department said.

Public health officials also expressed concern over a . The size of the event had been scaled back because of coronavirus concerns.

Participants underwent temperature checks as part of coronavirus protocols. Organizers also reminded the marchers to practice social distancing and wear masks, though many were bare-faced and packed together.

Before a Trump rally Friday night in New Hampshire, a campaign advisory said masks for attendees were required in accordance with Republican Gov. Chris Sununus executive orders, and would be provided.

Before Trump arrived, many in the crowd did not put their masks back on after singing the national anthem. They later booed when a campaign staffer called on them to do so.

Wen, the former Baltimore health official, said the White House event gives the public the false impression that precautions are no longer necessary.

We, in public health, have been trying to share, to put out guidance on what to do, and when we have the president of the country and top leaders doing exactly what we are asking people not to do, how can we be seen as credible? she asked.

On Friday, North Carolina for not keeping his face mask on at the White House.

Tillis, who is in a tough reelection bid against Democrat Cal Cunningham, has been consistent about talking up face coverings as a key method to slow the spread of COVID-19.

Tillis campaign tweeted a picture of the first-term senator wearing a mask on the White House lawn on Thursday before Trumps speech. But other media outlets later showed images of the crowd during the speech and Tillis was seen not wearing his mask.

It was very hard to reconcile those images with what is known about prevention and public health, said Dr. Howard Koh, a public health professor at Harvard and a former assistant secretary at the Department of Health and Human Services under President Barack Obama.

Koh said one mitigating factor was that Trump held the event outdoors.

He said wearing facial coverings during outbreaks is expected behavior in some Asian societies and social distancing, wearing masks and avoiding large crowds are new social norms that can save lives in the United States as well.

Koh said the same guidance applies to protests, but that moving around during demonstrations might help curb the spread of the virus.

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This story was first published on August 28, 2020. It was updated on August 29, 2020 to correct that Dr. Howard Koh, a public health professor at Harvard University, said it was hard to reconcile the images of the crowd on the South Lawn given what is known about public health practices to help prevent the spread of the coronavirus, not that he recoiled at the images of Trump supporters crowded on the South Lawn.

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Usain Bolt to 'stay in' while awaiting results of virus test - Wilkes Barre Times-Leader

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Endocrinology is the study of medicine that relates to the endocrine system, which is the system that controls hormones.Endocrinologists are specially trained physicians who diagnose diseases related to the glands. Because these doctors specialize in these conditions, which can be complex and have hard-to-spot symptoms, an endocrinologist is your best advocate when dealing with hormonal issues.

Most patients begin their journey to the endocrinologist with a trip to their primary care provider or family doctor. This doctor will run a series of tests to see what could be the potential problem the patient is facing. If a problem with the hormones is suspected, the primary care doctor will provide a referral. The endocrinologist's goal is to restore hormonal balance in the body.

The glands in a person's body release hormones. Endocrinologists treat people who suffer from hormonal imbalances, typically from glands in the endocrine systemor certain types of cancers. The overall goal of treatment is to restore the normal balance of hormonesfound in a patient's body.

Most of the work performed by an endocrinologist serves as the basis for ongoing research. Some endocrinologists work solely as research physicians. The goal of the research is to come up with new ways to better treat hormonal imbalances, including the development of new drugs.

The first step to become an endocrinologist is earning a bachelor's degree from an accredited college or university. Toward the end of the bachelor's program, a student will then have to apply for and be accepted to medical school. Once accepted, four more years of schooling will have to be completed. Most endocrinologists will complete a residency that lasts anywhere from three to four years. After schooling has been completed, it is then mandated that a state license be obtained.

Common courses that will have to be completed to become an endocrinologist include:

It usually takes at least 10 years for a person to complete all of the necessary coursework, schooling and training to become an endocrinologist. From the year 2010 through 2020, there is an expected growth rate of 24 percent for this position. Before a person starts the educational path to becoming this type of physician, it is highly recommended that he or she carefully consider whether or not it is the right path.

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What is Endocrinology? | Hormone Health Network

Hormones are your bodys chemical messengers. Produced in the endocrine glands, these powerful chemicals travel around your bloodstream telling tissues and organs what to do. They help control many of your bodys major processes, including metabolism and reproduction.

When you have a hormonal imbalance, you have too much or too little of a certain hormone. Even tiny changes can have serious effects throughout your whole body.

Think of hormones like a cake recipe. Too much or too little of any one ingredient affects the final product. While some hormone levels fluctuate throughout your lifetime and may just be the result of natural aging, other changes occur when your endocrine glands get the recipe wrong.

Read on to learn more about hormonal imbalances.

Your hormones play an integral role in your overall health. Because of that, theres a broad range of symptoms that could signal a hormonal imbalance. Your symptoms will depend on which hormones or glands arent working properly.

Common hormonal conditions affecting both men and women could cause any of the following symptoms:

In women, the most common hormonal imbalance is polycystic ovary syndrome (PCOS). Your normal hormonal cycle also changes naturally during:

Symptoms of a hormonal imbalance specific to women include:

Testosterone plays an important role in male development. If you arent producing enough testosterone, it can cause a variety of symptoms.

In the adult male, symptoms include:

Puberty is the time when boys and girls start producing sex hormones. Many children with delayed puberty will go on to experience normal puberty, but some have a condition called hypogonadism. Symptoms of hypogonadism include:

In boys:

In girls:

There are many possible causes for a hormonal imbalance. Causes differ depending on which hormones or glands are affected. Common causes of hormonal imbalance include:

Many causes of hormonal imbalance in women are related to reproductive hormones. Common causes include:

Theres no single test available for doctors to diagnose a hormonal imbalance. Begin by making an appointment with your doctor for a physical exam. Be prepared to describe your symptoms and the timeline along which theyve occurred. Bring a list of all medications, vitamins, and supplements youre currently taking.

Your doctor may ask you questions such as:

Depending on your symptoms, your doctor may suggest one or more diagnostic tests. You can also ask your doctor to perform these tests.

Your doctor will send a sample of your blood to a lab for testing. Most hormones can be detected in the blood. A doctor can use a blood test to check your thyroid, estrogen, testosterone, and cortisol levels.

If youre female,your doctor may perform a pap smear to feel for any unusual lumps, cysts, or tumors.

If youre male, your doctor may check your scrotum for any lumps or abnormalities.

An ultrasound machine uses sound waves to look inside your body. Doctors may use an ultrasound to get images of the uterus, ovaries, testicles, thyroid, or pituitary gland.

Sometimes more advanced tests are required. These can include:

If youre experiencing symptoms of menopause, you may be tempted to try a home testing kit. Home testing kits measure follicle-stimulating hormone (FSH) in your urine. FSH levels increase when you enter menopause, but levels also rise and fall during a normal menstrual cycle. A home testing kit can give you an indication of whether menopause has started, but it cant tell you conclusively.

Treatment for a hormonal imbalance will depend on whats causing it. Common treatment options include:

If youre experiencing uncomfortable symptoms of menopause like hot flashes, your doctor may recommend a low dose of estrogen. Be sure to discuss the risks and benefits of hormone replacement therapy with your doctor.

If youre experiencing vaginal dryness or pain during sex, you may want to try applying an estrogen cream, tablet, or ring. This local therapy treatment avoids many of the risks associated with systemic estrogen, or estrogen that travels throughout the bloodstream to the appropriate organ.

If youre trying to get pregnant, hormonal birth control can help regulate menstrual cycles. Types of hormonal birth control include:

It may also help improve acne and reduce extra hair on the face and body.

Androgens are male sex hormones that are present in both women and men. Women with high androgen levels may choose to take medication that blocks the effect of androgens, such as:

Metformin is a type 2 diabetes medication that may help some women with PCOS symptoms. It isnt approved by the U.S. Food and Drug Administration (FDA) to treat PCOS, but it might help lower androgen levels and encourage ovulation.

Testosterone supplements can reduce the symptoms of low testosterone in men. In adolescents with delayed puberty, it stimulates the start of puberty. It comes as an injectable, patch, and gel.

In people with hypothyroidism, the synthetic thyroid hormone levothyroxine (Levothroid, Levoxyl, Synthroid, Unithroid) can bring hormone levels back into balance.

Addyi and Vyleesi are the only medications that are FDA-approved for the treatment of low sexual desire in premenopausal women. Addyi is a pill, and Vyleesi is a self-administered injectable medication.

These drugs may come with some serious side effects, such as severe nausea and changes in blood pressure. Talk to your doctor to see if either one could be right for you.

This is a prescription cream designed specifically for excessive facial hair in women. Applied topically to the skin, it helps slow new hair growth, but doesnt get rid of existing hair.

There are many nutritional supplements on the market that claim to treat menopause and hormone imbalance. However, few of them are backed up by scientific evidence.

Many of these supplements contain plant-derived hormones. These are sometimes called bioidentical hormones because they chemically resemble the bodys natural hormones. There is no evidence to suggest that they work better than regular hormone therapy, though.

Some people find that yoga helps treat symptoms of hormonal imbalance. Yoga is excellent for your strength, flexibility, and balance. It may also help you lose weight, which can help regulate your hormones.

You can also make the following lifestyle changes:

The primary cause of acne is excess oil production, which leads to clogged pores. Acne is most common in areas with many oil glands, including the:

Acne is often associated with pubescent hormonal changes, but theres actually a lifelong relationship between acne and hormones.

The menstrual cycle is one of the most common acne triggers. For many women, acne develops the week before you get your period and then clears up. Dermatologists advise hormonal testing for women who have acne in combination with other symptoms, like irregular periods and excess facial or body hair.

Androgens are male hormones present in both men and women. They contribute to acne by overstimulating the oil glands.

Both girls and boys have high levels of androgens during puberty, which is why acne is so common at that time. Androgen levels typically settle down in the early 20s.

Hormones play an integral role in metabolism and your bodys ability to use energy. Hormone disorders like hypothyroidism and Cushing syndrome can cause you to become overweight or obese.

People with hypothyroidism have low levels of thyroid hormones. This means that their metabolism doesnt work as well as it should. Even when dieting, people with hypothyroidism can still gain weight.

People with Cushing syndrome have high levels of cortisol in their blood. This leads to an increase in appetite and an increased fat storage.

During menopause, many women gain weight because the metabolism slows down. You may find that even though youre eating and exercising like normal, you still gain weight.

The only way to treat weight gain from a hormone disorder is to treat the underlying condition.

During a normal, healthy pregnancy, your body goes through major hormonal changes. This is different than a hormonal imbalance.

Hormonal imbalances like PCOS are among the leading causes of infertility. In women with PCOS, the hormonal imbalance interferes with ovulation. You cant get pregnant if youre not ovulating.

Pregnancy is still possible in women with PCOS. Losing weight can make a big difference in your fertility. There are also prescription medications available that can stimulate ovulation and increase your chances of becoming pregnant.

In vitro fertilization (IVF) is also an option if medication doesnt work. As a last resort, surgery can temporarily restore ovulation.

PCOS can cause problems during pregnancy, for both you and your baby. There are higher rates of:

Babies born to women with untreated hypothyroidism have a higher risk of birth defects. This includes serious intellectual and developmental problems.

Hormonal changes and imbalances can sometimes cause temporary hair loss. In women, this is often related to pregnancy, childbirth, or the onset of menopause. An over- or underproduction of thyroid hormones can also cause hair loss.

Most hair loss, like male pattern baldness, is hereditary and unrelated to hormonal changes.

Hormone imbalances are associated with many chronic, or long-term, health conditions. Without proper treatment, you could be at risk of several serious medical conditions, including:

Hormones are responsible for many of your bodys major processes. When hormones get out of balance, the symptoms can be extremely varied. Hormonal imbalance can cause a variety of serious complications, so its important to seek treatment as soon as possible.

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Hormonal Imbalance: Symptoms, Treatment, Tests, and Causes

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Testosterone Replacement Therapy market to Grow at a Whopping 4.4% from 2019 to 2027 - The Daily Chronicle

It wasnt the first time Sharon Haber found a lump in her neck. Shed had them twice before the last one 10 years prior. Both times, they were benign. Still, she knew she had to get it checked out.

Habers primary care doctor in Encino, California, agreed that the small lump in her neck, under her left ear, most likely was nothing. But he ordered a CT scan, just in case. When the scan came back, the doctor still believed the lump was benign. Out of an abundance of caution, he sent her to a head and neck specialist for a second look. The specialist biopsied the lump, which he also expected to be benign.

A couple of days later, when I got the call that I have cancer, that was probably the scariest moment of my life, Haber says. The 69-year-old retired marriage and family counselor now has been cancer free for more than six years.

Haber had three lesions on her parotid gland one of the three major salivary glands and the most common one on which tumors can form. The majority of growths that develop on this gland are benign. In fact, salivary gland cancers are extremely rare. In the U.S., they make up less than 1% of all cancers diagnosed each year.

And thats cases spread throughout the U.S., so, of course, a lot of people havent even heard of it, says Dr. Maie St. John, chair of head and neck surgery at Ronald Reagan UCLA Medical Center in Los Angeles.

There are dozens of types of salivary gland cancers nearly as many as there are types of cells that compose the salivary glands. Most of the time, these can be treated with single modality surgery, depending on the anatomic location, and patients can have a very good outcome. Doctors usually recommend radiation after surgery to ensure no cancer cells are left behind and to lower the risk of recurrence. But for some people surgery is not possible or doesnt completely remove the cancer. In some cases, the cancer returns. Clinical trials underway are exploring the roles that chemotherapy and targeted drugs can play in treating this rare disease.

WHAT IS SALIVARY GLAND CANCER?

Cancerous tumors can arise in the three major salivary glands or any of the thousands of minor glands that line the mouth and extend into the nose and pharynx, the cavity that connects the nose and mouth to the esophagus.

The three pairs of major salivary glands are the parotid, sublingual and submandibular glands. The parotid, the largest of these glands, occupies the side of the face between the ear and the back molars. It extends to the height of the upper and lower jaws. The sublingual gland sits in the floor of the mouth under the tongue. The submandibular is located under the lower jaw.

Doctors grade cancers from low to high based on how abnormal the cells look under a microscope. Low-grade cancer cells look the most like normal cells and tend to be slower growing and less aggressive. These cancers are usually easier to treat and have better long-term survival rates. High-grade cancers, on the other hand, look very different from normal cells and grow and spread faster than lower grade cases.

Salivary gland cancers are as diverse as they are rare.

There are many differences in salivary gland cancers, says Dr. Ashok Shaha, the Jatin P. Shah Chair in Head and Neck Surgery and Oncology at Memorial Sloan Kettering Cancer Center in New York. The greatest variation in human cancers is probably in salivary gland tumors. And the more we look into the basic differentiation of these cells, the more different names for them keep coming up.

Mucoepidermoid carcinomas are the most common salivary gland cancers. They most often arise in the parotid gland but can appear in the other major glands, as well. These are usually low-grade cancers, but intermediate- and high-grade cases do occur.

Adenoid cystic carcinomas are slow growing, low- grade cancers, but they spread along nerves. Even if you go in and remove everything you can see and feel, there still could be a few cells that run along the nerve. Those cells spread by using the nerve like a little highway, and this would predispose patients to recurrence, St. John says. This type of cancer can recur many years after the initial treatment.

Adenocarcinoma is a general term to describe cancers of the gland cells. Salivary adenocarcinoma describes numerous subtypes of both low- and high-grade cancers, some of them quite rare.

WHAT ARE THE SYMPTOMS?

A common symptom of salivary gland cancers, particularly those that arise in the parotid gland, is a lump in the side of the face or neck like Haber had.

Something I hear from my male patients is I was shaving, and I felt this lump, says Dr. Theodoros Teknos, president and scientific director of the UH Seidman Cancer Center and a head and neck oncologist at University Hospitals Cleveland Medical Center.

A painless lump could be an early sign of cancer. As the disease progresses, depending on the location of the tumor, it can cause earaches, trouble swallowing or difficulty opening the mouth.

Numbness and pain can develop in the face, as well. Its not a sudden paralysis such as Bells palsy. The gradual numbness may start with one lip, then include another, and eventually spread to other parts of the mouth or face.

Mark Fetterman, a 59-year-old construction foreman in Olmstead Falls, Ohio, started having pain and numbness on one side of his face in 2016. A neurologist told him he had trigeminal neuropathy. This disorder affects the trigeminal nerve, which controls facial sensation and movement. Imaging tests didnt find any cause for the condition. The doctor prescribed medications, but over the next two years, the pain and numbness became worse. In 2018, Fetterman found a lump in the roof of his mouth. A biopsy found that it was salivary duct carcinoma, a rare, high-grade adenocarcinoma.

The [physician] said that the cancer was all along the trigeminal nerve going up to his brain, but not in his brain, and that it might have been this all along, says Fettermans wife, Lori.

SURGERY & RADIATION

For almost everyone with salivary gland cancer, surgery is the first treatment. Depending on the tumors location and size, the surgeon may be able to remove the cancer completely. But, because tumors may be near the eyes, in the mouth or nose, near the brain, or in the face on crucial nerves or blood vessels, the surgery comes with risks of adverse effects. It can cause temporary or permanent loss of movement in the face. But surgeons make every effort to avoid this.

We do parotid surgery with a nerve monitor so you can monitor and preserve the nerve, St. John says. We do not sacrifice the facial nerve unless the cancer is just wrapped around it and it has to be taken in order to clear the cancer. Otherwise, we dissect around it.

Habers tumor was on her facial nerve. She knew going into it that surgery came with the risk of partial paralysis. All I could think about was my grandkids, she recalls.

I didnt want to look scary to them. But after an 11-hour surgery performed by St. John, Haber says, she not only got all the cancer, and took out all the lymph nodes around it, but she did not hit that nerve. She saved my face and my life.

Doctors often recommend following surgery with radiation therapy to address residual microscopic cancer cells. If a tumor is inoperable, radiation sometimes in combination with chemotherapy may be the main treatment.

SYSTEMIC TREATMENTS

Chemotherapy isnt a first-line treatment for salivary gland cancers. Salivary gland cancers are considered relatively chemo-resistant tumors, says Shaha. If a patient has a poor prognosis or if they have [had a recurrence], then we would add chemotherapy.

Investigators are exploring through clinical trials whether chemotherapy, which is not typically used for salivary gland treatment, might improve outcomes when added to surgery and radiation.

In general, systemic treatments medications that travel through the bloodstream as opposed to procedures that target the tumor directly for salivary gland cancers are considered experimental. Patients with recurring or metastatic cancers may receive these treatments in clinical trials.

In a salivary gland cancer thats metastasized, we typically (gene) sequence the tumor, look at the muta- tions, and try to provide targeted therapies for the specific tumor, Teknos says.

In salivary duct carcinomas, for example, the HER2 gene is often overactive. The genes hyperactivity can help the tumor grow and thrive. In HER2-positive tumors, the blockbuster breast cancer drug Herceptin (trastuzumab) blocks that genes activity and may slow or stop tumor growth.

Fetterman is still taking Herceptin. He receives an IV transfusion of the drug every three weeks. On the last CT scan, the cancer was unchanged. It hadnt grown or shrunk. So I will continue to take it, and they will just keep monitoring it, he says.

People with this type of cancer also may be candidates for androgen receptor inhibitors, drugs commonly used to treat prostate cancer. Androgen receptors, which by some estimates, are present in up to 98% of salivary duct carcinomas, support the growth of tumors that thrive on androgen hormones. These drugs can block the receptors and deprive the tumor of the hormone. In a clinical trial, this treatment led to higher response rates than chemotherapy in metastatic or recurrent disease.

In other clinical trials, investigators are exploring other genetic targets in salivary gland tumors that might align with existing targeted drugs. In the phase 2 MyPathway trial (NCT02091141), researchers matched patients with targeted drugs based on the tumors genetic profile. Because salivary cancers are so rare, the trial included only 19 people. Twelve of them (63%) responded to the personalized treatments they received.

Numerous other trials are in progress. In cases of metastatic or recurring salivary gland cancers, clinical trials may be the only remaining treatment options.

FINDING CARE

Because salivary gland cancers are so rare, doctors recommend that patients find a hospital with a track record. You dont need to go to another state, Shaha says, but you need to go to a center where head and neck surgery is very common and there are recognized experts in salivary gland tumors.

But its not just the surgeon that matters. Salivary gland cancers can affect facial appearance and function and psychological well-being. Treatment can require a team. Reconstructive surgeons help maintain or restore facial appearance. Physical and speech therapists work with patients to maintain function. Radiologists and medical oncologists collaborate on nonsurgical aspects of care. Mental health professionals provide support for coping with life changes brought about by the cancer.

It is what we call a multidisciplinary team, Shaha says. You need a good surgeon. You need a good radiologist. You need a medical oncologist. You need a radiation therapist or radiation oncologist, and a good pathologist. If you have that team, thats a real place where you want to be treated.

Continued here:
Salivary Gland Cancer: As Rare As It Is Diverse - Curetoday.com

Biomedical engineers at Duke University have shown that the efficacy of a two-pronged type 2 diabetes treatment increases when the drugs are linked by a heat-sensitive tether rather than simply concurrently administered. The combination molecule is formed by an elastin-like polypeptide (ELP) linker that forms a gel-like depot when injected under the skin, which slowly dissolves and releases the active drug over time.

This novel approach features the commonly prescribed type 2 diabetes drug glucagon-like peptide-1 (GLP-1) and the compelling drug candidate fibroblast growth factor 21 (FGF21) that together create tight glycemic control and potent weight-reduction in diabetic mice. Coupled with the slow-release function of the ELP, the effects last longer than one week with a single injection.

Because GLP-1, a short peptide, and FGF21, a large folded protein, are such different compounds, these findings suggest that this approach to combination drug design could be applied to disease therapies beyond diabetes.

The results appear online on August 26 in the journalScience Advances.

"In the burgeoning field of multi-functioning single-molecule diabetes drug design, researchers primarily unite drugs that are similar in size, structure and function," said Caslin Gilroy, a postdoctoral scholar at the University of California, Berkeley, who led the project while completing her PhD in biomedical engineering at Duke. "Being able to combine such structurally distinct drugs into a single molecule while maintaining the bioactivity and stability of each is a big technological achievement."

Type 2 diabetes is a progressive disease where body tissues become resistant to the effects of insulin, which regulates the movement of sugar from the bloodstream into cells. When this carefully tuned system breaks down, blood sugar levels remain toxically elevated and a host of serious complications can follow. While many treatment options exist, a single drug is rarely able to treat an advanced case. Conventional medications lose their potency over time and frequently cause weight gain, which itself can promote insulin resistance and exacerbate the disease.

A growing class of drugs is based on GLP-1, a naturally occurring peptide released from the intestines after a meal. GLP-1 therapy enhances the release of insulin from the pancreas while promoting weight loss. However, the high doses of GLP-1 that are sometimes necessary to maintain healthy blood sugar levels have been shown to cause gastrointestinal distress. Researchers are exploring combination therapies that strategically pair GLP-1 with additional drugs to maximize glucose control, minimize side effects and augment weight loss.

While most drug combinations incorporate small peptides from the same family as GLP-1, Gilroy and Ashutosh Chilkoti, the Alan L. Kaganov Distinguished Professor of Biomedical Engineering at Duke, chose to work with FGF21. A metabolic hormone, FGF21 regulates insulin sensitivity, energy expenditure and fat metabolism within body tissues.

"FGF21 functions through a different mechanism than GLP-1, and we hypothesized that the two drugs would complement each other nicely," said Gilroy. "GLP-1 increases insulin secretion by the pancreas, while FGF21 enhances the body's response to the insulin. GLP-1 reduces food intake, while FGF21 helps burn more calories."

But rather than simply injecting diabetic mice with both drugs at the same time, the researchers decided to link GLP-1 and FGF21 together into a single molecule. This approach to combination therapy has several advantages. A single molecule is more predictable in how it will disperse through the body, act on its target tissues and eventually be cleared. A single drug is also beneficial for the prescribing physician and patient, as it reduces the medication burden and simplifies the treatment regimen. And the FDA approval process for a single drug is more straightforward than for a drug mixture.

GLP-1 and FGF21, however, are both peptide-based drugs, heavily reliant on shape and surface features to function. Tethering the two without interfering with either is easier said than done.

To form one drug out of two, the researchers turned to the ELP--a specialty of the Chilkoti research group. ELPs are chains of repetitive peptide sequences that are highly disordered in nature. This disorder provides flexibility, enabling drugs fused at each end of the ELP the room to do their respective jobs. The modularity of ELPs also make them highly tunable, allowing for the design of the best delivery system possible.

Peptide-based drugs suffer from two notable disadvantages; they have a short half-life, due to rapid clearance from the body, and they must be administered by needle. An ELP-based delivery platform, however, addresses both of these issues.

"Linking the drugs to an ELP allows us to design a compound that is liquid at room temperature but forms a gel-like depot upon injection," said Gilroy. "The depot dissolves over the course of at least a week, slowly and regularly releasing drug to the system over time."

Chilkoti already has two Phase II clinical trials underway using ELPs as slow-release delivery systems. One trial aims to treat pulmonary arterial hypertension, while the second involves a potential therapy for COVID-19.

In the study, after verifying that GLP-1 and FGF21 retain their respective functions and potencies when linked together by an ELP, Gilroy and Chilkoti tested their multi-functioning, slow-release molecule in a mouse model of diabetes.

The results show that levels of drug circulating in the system remained steady while blood sugar levels were brought down to a healthy level and maintained for up to 10 days following a single dosing. Mice treated with the GLP-1/FGF21 combination drug were better able to recover from a glucose challenge compared to either drug alone, and were the only test group to lose weight during the trial.

The drug combination also worked better when GLP-1 and FGF21 were tethered together rather than being delivered as a mixture of individual drugs. The researchers think that linking them guarantees that GLP-1 and FGF21 are always acting in concert at the same point in time, allowing their mechanisms of action to synergize and work together.

"We had speculated that we may see synergy when we combined GLP-1 and FGF-21 because they have different modes of action," said Chilkoti. "That was really just a hope at the outset of this project, and we were more than pleasantly surprised when Caslin showed that combining these drugs into a single molecule clearly showed a synergistic therapeutic effect compared to a mixture of the two drugs. The data is so compelling that we believe it's ready for a company to pursue this strategy commercially. Duke's Office of Licensing and Ventures is currently looking to license it."

Reference: Gilroy CA, Capozzi ME, Varanko AK, et al. Sustained release of a GLP-1 and FGF21 dual agonist from an injectable depot protects mice from obesity and hyperglycemia. Sci Adv. 2020;6(35):eaaz9890. doi:10.1126/sciadv.aaz9890

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Type 2 Diabetes Drugs Work Better Tethered Together - Technology Networks

There was a very popular meal replacement that was all the rage in 2013 Soylent, were talking about Soylent whose inventor lived on it for one month straight and said he felt superb. Better skin, better energy levels and above all, more productivity!

The product made headlines for the implication that you can live on nothingbut Soylent, although nowadays the company is careful to put a disclaimer on all of their products:Soylent is not intended to replace every meal, but it can replace any meal.

Thats the tactic that we take toward meal replacements: that they can be a useful, although not perpetual, replacement for a meal.

Now, weve tried dozens and dozens of these supplements to land on our list of best meal replacements, and while there are plenty of crummy options that are low in protein and low in nutrients some of them are, well, really good.

Our top pick Huel, for example, has 28 vitamins and minerals, a good balance of macronutrients, its not too low in calories, and it even provides Omega-3 fatty acids.

So why cant I just live on this shake alone?

Editors note: The content on BarBend is meant to be informative in nature, but it shouldnt take the place of advice and/or supervision from a medical professional. The opinions and articles on this site are not intended for use as diagnosis, prevention, and/or treatment of health problems. Speak with your physician if you have any concerns.

I have seen a study or two on satiety and hunger. They were comparing people eating food and people drinking a smoothie, says New York-based dietitian Natalie Rizzo, MS, RD. They found people who have to chew the food feel fuller after chewing, even if its the same nutrients and calories.

This study was published in Hormone and Metabolic Research in 2007, and it did indeed conclude that hunger hormones like ghrelin were affected differently in solid versus liquid food.(1) It concluded that shakes,

led to differential appetitive responses and should not be viewed as dietary equivalents in older adults.

But, well, its never that hard to find studies with opposing conclusions.Here are three (2)(3)(4) that said meal replacements can safely and effectively produce significant weight loss and may help to manage blood sugar.

This is not medical advice, mind you talk to a physician before starting a new supplement regimen, especially if you have diabetes. The point is, well, research is conflicting with the appetite stuff. What if you dont struggle with your appetite? Or you take a fiber supplement, like psyllium husk, that can boost satiety? Or what if youre not trying to lose weight?

[Related: Micronutrients vs Macronutrients What Should You Focus On?]

What if your meal replacement is really good?

Not something like Slimfast, which has just 2 grams of protein per serving. Lets say its something like Huel, who we promise did not sponsor this article. Its got a good balance of macros and calories 500 per adjustable serving with 37 grams of protein, 47 grams of carbs and 16 grams of fat Omega-3s, and about 30 percent of the recommended daily intake of 28 vitamins and minerals, including uncommon ones like chromium, choline, chloride.

Youll never make an actual meal with so much of every micronutrient! Why shouldnt I just take this all day, every day?

Ithink that there are some things youre going to miss out on, says Rizzo.There arethings you dont see on the food label that are important, like antioxidants and phytochemicals.Those are plant compounds that have been shown to be really beneficial to heart health and disease risk, things like that.

Wait a minute. Arent macronutrients (protein/carbs/fat) and micronutrients (vitamins/minerals) the only things the government says you need to consume?

Essentially, every single plant-based food has things like antioxidants and phytochemicals and phytonutrients, Rizzo explains.There are thousands of them.The ones we know a lot about are flavonoids, which are usually in the darker colored foods resveratrol is an example thats found in reddish colored foods like grapes and berries that may improve heart health.

Other examples that are just found in broccoliinclude

There are tons of other phytonutrients, and a really big benefit many can confer is their antioxidant effect: they may help to combat inflammation.

Inflammation comes in two different forms, says Rizzo. Theres acute, which is short term and something your body will naturally repair itself from, like the effect of a workout or a bruise. But then theres long term inflammation, which is associated with obesity and chronic disease.If you have inflammation built up in your body for a long period of time, you have a higher risk of developing chronic diseases, and research has found that people who eat more foods with antioxidants and phytochemicals have a lesser chance of getting these sorts of diseases.

Importantly, antioxidants and phytochemicals are not on any food labels, theyre very hard to measure, and the FDA has not set a recommended daily intake for them.

Youll live without these things youve probably met people who live without any vegetables at all but evidence strongly suggests youll live better with them.

[Related: The Best Foods and Supplements for Fighting Inflammation]

Besides phytonutrients, there are other important components to our food that dont have recommended daily intakes, like digestive enzymes.Proteases, lipases, amylases, these are found in whole foods and help you to better absorb the nutrients you do eat they help you make the most of your calories.

Add to that prebiotic fiber and probiotic bacteria. They may improve the health of the trillions of bacteria that live in your digestive tract, and those bacteria may exert an effect on not only your nutrient absorption, but your immunity, inflammation, and physical performance.

[Related: Why Probiotics Are Extra Important for Athletes]

So you kind of just have to eat food.

Meal replacement shakes can have their place but,

At least eat a lot of cruciferous vegetables every day. They have links to just about every health benefit under the sun.

Ideally, youll get all your nutrients from whole foods but hey, sometimes you get busy. Or lazy. We get it, thats why we have meal replacements several times a week but always with some fruits or veggies on the side and with lots of whole foods over the rest of the day.

1.Tieken, SM et al. Effects of Solid versus Liquid Meal-replacement Products of Similar Energy Content on Hunger, Satiety, and Appetite-regulating Hormones in Older Adults. Horm Metab Res. 2007 May; 39(5): 389394.2.Heymsfield, SB et al. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord . 2003 May;27(5):537-49.3.Boonyavarakul, A et al. Effects of meal replacement therapy on metabolic outcomes in Thai patients with type 2 diabetes: A randomized controlled trial. Nutr Health . 2018 Dec;24(4):261-268.4.Kempf, K et al. Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients. Nutrients . 2018 Aug 4;10(8):1022.5.Auborn, K et al. Indole-3-carbinol is a negative regulator of estrogen. J Nutr . 2003 Jul;133(7 Suppl):2470S-2475S.6.Melrose, J et al. The Glucosinolates: A Sulphur Glucoside Family of Mustard Anti-Tumour and Antimicrobial Phytochemicals of Potential Therapeutic Application. Biomedicines. 2019 Sep; 7(3): 62.7.Wu, X et al. Are isothiocyanates potential anti-cancer drugs? Acta Pharmacol Sin. 2009 May; 30(5): 501512.

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Could You Just Live On Meal Replacement Shakes? - BarBend

The thyroid is an essential endocrine gland that is located at the base of the neck and wraps around the front of the trachea. Its home to a variety of hormones that regulate functions throughout the body. A healthy thyroid gland ensures good metabolic, heart, bone, and muscle health.

The gland is also closely connected with the brain, helping it maintain internal homeostasis. The thyroid significantly influences processes like metabolism, heart rate, emotional responses, and body temperature.

Thyroid disorders can lead to an array of symptoms resulting from dysfunctions in the above processes.

Researchers have revealed some connections between the bodys endocannabinoid system (ECS) and thyroid/brain communication. The ECS might play a role in balancing hormones. If this theory is true, this would mean cannabis products such as CBD oil might be able to help with various types of thyroid disorders.

In todays article, we focus on using CBD oil for thyroid health on top of highlighting the best brands and products in 2020.

Royal CBD is a California-based brand established by a group of friends and cannabis advocates. The company offers premium CBD products in different cannabinoid profiles and concentrations to choose from. Royal CBD collection includes full-spectrum CBD oil, softgel capsules, THC-free gummies, and broad-spectrum topicals.

If youre looking for a high-quality product to support your thyroid health, this is one of the best brands on the market. These oils are available in four potency options, including 250 mg, 500 mg, 1000 mg, and 2500 mg of CBD per bottle. This is a great potency range for both beginners and experienced users alike. The strongest option provides 83.3 mg of CBD per milliliter.

Royal CBD uses organic hemp from Colorado to produce its CBD oils. The plants are gently extracted under low temperatures with pressurized CO2 to ensure the highest purity and consistent purity throughout every batch of products. The company sends samples of their CBD extracts to an independent laboratory for meticulous content analysis.

Similar to Royal CBD, Gold Bee was founded in California, which is no wonder given the size of the cannabis market there and its domination throughout the country. Gold Bee offers some of the best-tasting CBD oils out there; the guys at Gold Bee infuse their hemp extract with a natural honey flavor, which masks the earthiness of full-spectrum CBD.

These oils are great if youre just getting started with CBD or your daily dosage doesnt exceed 40 mg daily. Another great thing about this company is the fact that the other ingredients in its CBD oil, such as the carrier oil, are also sourced organically.

Gold Bee also has softgel capsules, gummies, and honey sticks in its product lineup.

CBDPure is also a good choice if you benefit from lower doses of CBD. This company sells two types of products: CBD oil and capsules. Both products are sourced from Colorado-grown hemp and gently extracted using supercritical CO2. These are full-spectrum extracts, so youre getting all beneficial phytonutrients from hemp on top of CBD, including trace cannabinoids, terpenes, flavonoids, and essential oils.

The CBDPure CBD oil is available in four concentrations: 100 mg, 300 mg, 600 mg, and 1000 mg. The 1000 mg bottle is the latest addition to the brands collection. CBDPure is one of the most transparent brands in the industry. Not only does the company cover all details about its activity, but it also provides third-party lab reports for each batch of products to prove their potency and purity.

CBDPure offers a 90-day satisfaction guarantee program. If you decide the companys products are not for you, you can send your order back for a full refund.

Hemp Bombs is one of the best companies if youre looking for high-quality CBD oils made from isolates. These products are mostly designed for people who are interested only in the health benefits of CBD for thyroid health. Hemp Bombs CBD oils have no odor and flavor, which makes them more versatile than full-spectrum products. The company also sells broad-spectrum extracts, where all the cannabinoids except for THC have been preserved to provide the user with the entourage effect.

Hemp Bombs CBD oils are available in a wide range of concentrations, from 125 mg to a massive 4000 mg of CBD per bottle. You can also choose between 4 delicious flavors, such as Acai Berry, Orange Creamsicle, Peppermint, and Watermelon.

The last brand in our ranking of the best CBD oils for thyroid health support, CBDistillery is one of the pioneer companies that helped establish the American CBD market as we know it today. The company was founded in 2016 as a daughter brand of Balanced Health Botanicals.

CBDistillery offers two types of CBD oil on top of other formats: full-spectrum and broad-spectrum CBD. The broad-spectrum version is labeled as pure oil; similar to Hemp Bombs, CBDistillery has removed the THC from the full-spectrum extract for those who are apprehensive about taking any THC into their bodies.

If youre looking for a wide range of potency options, youre going to have a great time browsing through CBDistillerys CBD oil. Whether youre a beginner or experienced consumer, the company has got you covered from 250 mg to 5000 mg of CBD per bottle. Although the high-potency oils have a higher price tag on the bottle, they turn out more affordable when you calculate the cost per mg of CBD oil.

CBDistillery offers some of the most affordable products in the industry, so if you dont mind the fact their hemp isnt organic, you can trust them as your next supplier especially if youre on a low budget.

Although the research on CBD and thyroid health is limited, current findings suggest that CBD may be beneficial for dealing with thyroid disorders.

According to a 2015 study published in BioMed Research, CB1 and CB2 cannabinoid receptors interfere with molecular pathways and influence the formation of thyroid tumors. Therefore, these receptors could be considered as potential blockers of tumor spread.

We still dont know how exactly CBDs affinity to cannabinoid receptors may affect conditions like Hashimotos Disease or Graves Disease, the presence of these receptors and their influence on thyroid health and function points to CBD as a possible therapeutic agent.

Other research also suggests that CBD and other cannabinoids may come in handy for managing symptoms associated with thyroid disorders, such as anxiety, depression, dry skin, inflammation, and pain.

In a study from the Journal of Experimental Medicine, the administration of CBD and its modified equivalents inhibited chronic inflammatory and neuropathic pain in rodents.

Scientists suggest that CBD taken orally and sublingually provides better effects for the symptoms triggered inside our bodies especially when it comes to stress and depression while topical products work better for localized problems.

The thyroid is prone to suffer from deficiencies in nutrients such as zinc, iodine, and selenium, as well as specific environmental factors, which can cause underperformance.

Also, the immune system can be aggressive towards the thyroid gland, leading to autoimmune thyroid disorders, such as Graves Disease and Hashimotos Disease.

Problems with the thyroid gland may include:

When theres too much or too little of the thyroid hormone, the results may wreak havoc to your well-being over time.

Thyroid disorders are particularly difficult because its challenging to detect and diagnose a specific disorder. Thyroid conditions can cause several problems related to physical functions.

However, doctors use special tests to check for thyroid imbalances. These tests include biopsies and imaging scans, such as iodine or ultrasound screenings. Blood tests that analyze levels of T3, T4, and thyroid-stimulating hormone (TSH) can also determine thyroid imbalances.

The THS measures the amount of thyroxine (T4) that the thyroid should produce.

Below we discuss the two major thyroid disorders: Graves Disease and Hashimotos Disease.

Graves disease received its name after Dr. Robert j. Graves, who first diagnosed a patient with this condition in 1835.

Graves disease is a type of autoimmune thyroid disorder that leads to hyperthyroidism, where the thyroid gland produces too much thyroid hormones. Graves disease is usually the main trigger of hyperthyroidism.

If you suffer from this thyroid disorder, you may experience irritability or nervousness, trembling hands, trouble sleeping, fast and irregular heartbeat, goiter, muscle weakness and tiredness, and weight loss.

Hashimotos thyroiditis is known by another name chronic lymphocytic thyroiditis. This disease is the root of hypothyroid symptoms. Most patients are women after their 40s, although the disease can affect any person regardless of their age.

This autoimmune thyroid condition, which was first diagnosed by Japanese physician Hakaru Hashimoto in 1912, signals the immune system to attack and compromise thyroid function, slowing down its hormone production.

At first, the symptoms are mild and nearly unrecognizable. These symptoms include fatigue, weight gain, hair loss, muscle aches, stiffness, dry skin, intolerance to cold temperatures, stiffness, tenderness, and irregular menstrual cycles (in women).

Doctors usually prescribe Levothyroxine to treat hypothyroidism.its a thyroid hormone used along with radioactive iodine and surgery to treat thyroid cancer. Levothyroxine is used to replace thyroid hormones usually released by the thyroid gland.

Without these hormones, the body cannot perform as usual, which may cause slow speech, lack of energy, muscle, and joint pain, irritation, depression, problems with vision, and slow growth.

A correct treatment with levothyroxine should reverse these symptoms and eventually solve problems with an underactive thyroid.

Most people who have thyroid dysfunction such as Hashimotos disease or Graves disease need to find an underlying autoimmune issue and tackle it. Just taking prescription meds for your disease will simply mask the symptoms.

The easiest thing you can do is embrace natural thyroid treatment and add it to your medication. This begins with adding to and cutting out the diet in the following ways.

Add these products to your diet:

On top of that, you should take care of sufficient protein intake to improve low thyroid function. Proteins may come from organic meat as well as from nuts, nut butter, quinoa, or eggs.

Last but not least, remember to eat more healthy fats. Lack of fats can deteriorate hormonal imbalance, including thyroid hormones. You should add products like ghee, avocado, olive oil, flax seeds, fish, nuts, nut butter, as well as organic diary-like yogurt and cottage cheese. Coconut milk is a good option to consider, too.

Cut out the following products from your diet:

The endocrine system consists of a series of glands in the body that release and secrete hormones for different purposes.

These hormones influence many different physiological processes, including metabolism, fertility, growth, movement, respiration, and sensory perception.

A study conducted by the Polish Society of Endocrinology in 2018 points to potential interrelations between the endocannabinoid system (ECS) and the performance of the endocrine system.

The ECS, the major communication and regulatory network, is responsible to maintain balance between biological processes to help the body maintain overall well-being. This includes controlling thyroid function.

To get a better understanding of how CBD may support thyroid health, its paramount to understand how the ECS functions.

The therapeutic effects of CBD and other cannabinoids are manifested through their interaction with the bodys ECS and its two types of receptors CB1 and CB2.

Scientists have discovered functional CB1 receptors on the thyroid of animal models. These CB1 receptors modulate the release of two thyroid hormones T3 and T4.

Each of these hormones plays a vital role in regulating energy levels, body temperature, body weight, as well as the growth of skin, hair, and nails.

Cannabinoid receptors also occur within the hypothalamic paraventricular nucleus (PVN), which is an area of the brain that communicates with the pituitary gland and signals it to release different types of stimulating hormones to organs like the thyroid, gonads, and adrenal glands.

CBD indirectly regulates these receptors and acts against cannabinoid agonists, which are substances that bind to a receptor to produce their effects.

CBD also has over 65 molecular targets in the body. One of them is the 5-HT1A receptor, which is responsible for serotonin balance. Serotonin is a neurotransmitter that contributes to feelings of relaxation, happiness, and well-being.

The above interactions hold the explanations of the potential healing mechanisms of cannabinoids on the endocrine system.

American Thyroid Association (ATA) reports that people with thyroid disorders choose complementary and alternative medicine for the management of the side effects coming from medication and conventional treatments, such as fatigue, dry mouth, weight gain, and mental fog.

Forming lifestyle habits that help you manage stress, bolster immunity, and prevent inflammation may help improve thyroid health. For example, the Anxiety and Depression Association of America (ADAA) recommends physical activities like exercise to help with sleep problems, which translates to stress reduction. The ATA, on the other hand, suggests yoga, massage, and Pilates reduce stress.

Improving overall immunity should help you fight environmental toxins. Maintaining a healthy diet is the key to avoiding infection. Proper hygiene habits and cooking meats thoroughly also helps build up immunity.

People with thyroid disorders often add anti-inflammatory foods like berries, fatty fish, turmeric, olive oil, or avocados to their diet. Many of the causes of thyroid disease are associated with prolonged inflammation and auto aggression

Using CBD oil may complement the lifestyle and nutrition adjustments, as it has been shown to reduce stress, anxiety, and inflammation, as suggested in a 2019 research paper.

For example, a 2017 study published in Frontiers in Immunology showed that phytocannabinoids strengthen the immune functions of the body. Data from 2018 shows that CBD demonstrates anti-inflammatory properties.

The aforementioned studies indicate that CBD is one of the many cannabinoids found in cannabis that can improve thyroid health and help with thyroid disorders. Therefore, when searching for CBD oil, opt for products that contain the full spectrum of cannabinoids.

Full-spectrum CBD means that the product has been made using the entire hemp plant. As such, it contains all phytonutrients from hemp, including CBD, trace cannabinoids (0.3% THC), terpenes, flavonoids, essential oils, and amino acids. These compounds create synergistic effects that amplify the benefits of each cannabinoid and the therapeutic value of the product.

This concept is better known as the entourage effect.

Those who dont want to take any THC for different reasons may opt for a broad-spectrum product, which contains all of the above except for THC, which has been removed after initial extraction.

However, no matter the type of CBD you choose, wed like to stress the importance of research and careful consideration in selecting the best CBD oil to help with thyroid health.

Follow these steps to save time and money on CBD oil:

If youre looking for a recommended CBD dosage for specific thyroid disorders or any other diseases, you may end up feeling disappointed.

As Peter Grinspoon, MD, says in his article written in Harvard Health in August 2019, experts dont know the most effective therapeutic dose of CBD for any ailment.

Without high-quality human trials, its impossible to determine effective doses. Moreover, Grinspoon says its actually difficult to know what the consumers are getting.

Its generally best to start at low doses, preferably 1-6 mg of CBD for every 10 pounds of your body weight. Grinspoons advice for those shopping for CBD products is to talk with a knowledgeable doctor who will be able to point you in the right direction when it comes to dosing CBD oil as well as to avoid negative interactions with other medications you might be taking.

In a 2017 study, researchers concluded that chronic CBD use in large doses of up to 1500 mg a day had been repeatedly demonstrated to be well tolerated by humans.

CBD is available in many various forms when it comes to managing symptoms commonly linked to thyroid disorders, such as anxiety, depression, pain, inflammation, and dry skin.

The route of administration a person chooses for taking CBD depends on their CBD goals and lifestyle.

CBD oil, capsules, and edibles such as gummies, are a convenient and easy way to take CBD oil, especially for first-time users.

These products are easy to incorporate into a routine, and you can keep the dosage consistent. Depending on your individual metabolism, the effects can last between 4 and 12 hours, so most of the time, youll need 1-2 doses during the day.

CBD oil drops are more efficient than capsules and edibles because they take less time to act and more CBD enters the bloodstream upon ingestion. This effect is caused by sublingual absorption; when you take CBD oil under the tongue, it absorbs through a complex network of blood vessels in your mouth, avoiding the first-pass effect in the liver.

The sublingual application brings results within 1530 minutes after its use, and the effects can last for 46 hours.

Peak blood levels of most substances administered sublingually are noticed within 1015 minutes, which is faster than those same compounds taken orally.

For localized problems, such as inflammatory pain, dryness, and other skin problems, topicals like CBD creams, gels, and patches may be applied to an affected area on the skin to relieve the discomfort. When shopping for topicals, make sure to look for keywords on the product labels that tell if the product uses encapsulation, micellization, or nanotechnology of CBD. These terms indicate that the product can pass through the dermal layers rather than just remaining on the skins surface.

Vaping CBD is the most bioavailable method for some people, delivering up to 56% of the inhaled content to a persons bloodstream. However, vaping raises concerns about potential health problems caused by additives that are infused into CBD oil to make it vapable.

The wide range of health benefits provided by CBD due to its interaction with the endocannabinoid system makes it a viable option for individuals seeking alternative options for treating symptoms of various conditions, including thyroid issues.

A properly assessed dose of thyroid hormone is critical in treating underactive or overactive thyroid. From there, individuals should also take care of their nutrition and introduce healthy changes to their lifestyles. CBD oil may also help regulate certain symptoms and assist the body in regulating its internal processes. However, using CBD for thyroid disorders still calls for more research.

If you think CBD oil could help you manage the symptoms associated with Hashimotos disease or Graves disease, we advise you to consult with a doctor who will be knowledgeable about cannabis treatments. Using professional help will make it easier to determine your optimal CBD dosage and avoid interactions with thyroid medication if youre already taking one.

Follow our recommendations for the best CBD oils for thyroid health, or do your own research according to our guide. Good luck!

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CBD Oil for Thyroid: Is Hemp a Good Treatment for Hypothyroidism? - Weed News

On the nights when the mental sexual images of children were most overwhelming, Joseph Parker took cold showers and baths, hoping the shock of freezing water would push his intrusive thoughts away. Other times, he would fixate on a picture of the Sri Lankan Buddhist monk Henepola Gunaratana, so that the monk's "wrinkly face" might replace the disturbing imagery in his head.

Parker, who is using a pseudonym to protect his identity, had known he was attracted to children since he was 17, but he didn't start having overpowering sexual urges until he was 24. (He's now 26.) These urges were the worst when he was falling asleep. "As soon as I tried to release myself from wakefulness, my mind would sink into the pool of sexual energy, and I would feel this horrible sense of joy and happiness towards children, he said.

He read online about medications that could lower testosterone levels and, as a result, sex drivea process sometimes referred to as "chemical castration." When he asked a psychiatrist for these drugs, he was given Risperidone, an antipsychotic, instead. He took that for about a year, then added on Sertraline, an antidepressant, but only found these drugs mildly helpful. He turned to the internet to get what he had wanted in the first place.

From a website based in Turkey that sells pharmaceuticals, he ordered cyproterone acetate, which lowers testosterone, along with the female hormone estradiol, and now takes the two medications together. The website that processes the sales is frequently shut down because of its illicit nature: "To my knowledge this is their third or fourth website change, at least, since I came upon them 14 months ago," he said.

Parker wishes it wasn't this hard for pedophiles to get sex-drive reducing medications. But for many pedophilesand especially pedophiles who have not committed crimesaccess to even talk therapy, let alone medication, can be difficult to come by, and the process is riddled with fears about being reported to legal authorities.

In the past several decades, researchers have arrived at new understandings about pedophilia, the sexual attraction to children. Pedophilia appears to be an in-born sexual preference, something a person does not choose and cannot change. A pedophile's attraction to children is consistentnot a phaseand they develop their attraction to children around the same time that other people develop sexual attractions.

While researchers' knowledge has been evolving, access to widespread, up-to-date healthcare hasn't kept up pace. Outside of the handful of researchers who provide therapy and medication to pedophiles, the barriers to finding an informed therapist or psychiatrist remain high. This has led to a hodgepodge of therapeutic approaches in the community, or people self-medicating, like Parker did. Many pedophiles are only directed towards treatment in the context of the criminal justice system, where in some states, chemical castration is used on sex offenders.

Yet importantly, researchers have established there's a distinction between pedophilia and child molestation, a difference between the attraction itself and the crime. Most people hear these words and think that they're synonyms. They're not, said James Cantor, a Canadian clinical psychologist and neuroscientist who studies pedophilia.

Only about half of child sex offenders are genuine pedophiles. The other half prefer adults sexually, and are abusing children because theyre available or easily manipulated. (Child porn offenders, on the other hand, are nearly always pedophiles because of the ready availability of adult porn alternatives.)

The goal of any modern, preventative treatment for pedophila should be to help people manage their sexual interests rather than try to change them, Cantor said. This can involve the voluntary use of hormone-reducing medication to control urges or therapy. Since pedophilia and sexual abuse are not synonymous, treatment for pedophilia is also not solely about preventing child sexual abuseits about helping people with their overall mental health and well-being too. Thats a concept that may be hard to accept. It involves recognizing that people who are sexually attracted to children deserve to live healthy and meaningful lives.

Online support groups for non-offending pedophiles have only recently entered the public eye. The most well-known group, the Virtuous Pedophiles, was formed in 2012 as a safe place for pedophiles to discuss their struggles and commitment to not offend. Parker belongs to the Virtuous Pedophiles and is known to the community as Double22. Another organization, the Association for Sexual Abuse Prevention (ASAP) was formed by some members of the Virtuous Pedophiles, and they are currently ramping up their goal to create a platform to connect pedophiles to mental health professionals.

"In my opinion, they should not be seen as second class patients.

In April of this year, the first randomized placebo-controlled study of a hormone-reducing drug for pedophilia took place in Sweden. Published in JAMA Psychiatry, it found that the drug reduced both high sexual desire and sexual attraction to children, and that the effects were noticeable within two weeks.

The study is the first to include people who self-identified as pedophiles and were seeking help of their own accord, not just people funneled from the criminal justice system. Whats even more remarkable about the study is that it included a placebo groupthe first pedophilia study to do so. In an editorial about the study, Peer Briken, a professor of sex research at the University Medical Centre Hamburg-Eppendorf in Germany, wrote that it marks a milestone in clinical sexual science and the field of forensic psychiatry.

I think one of the biggest problems is that people just don't understand this as a mental health issue, said Fred Berlin, an associate professor in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. Rightfully, people are concerned about protecting children. And so we just quickly stigmatize people who are attracted to children and often don't even see them as human beings with a problem who might be deserving of help.

"In my opinion, they should not be seen as second class patients.

In 2014, journalist Luke Malone wrote an article about young people, some of them minors, who were discovering that they were attracted to children, and how they were coping with it. It was adapted as an episode of This American Life, one of several high-profile media pieces about pedophiles that explored the complicated existence of being born attracted to childrenand how hard it is to get help.

When Adam, one of the young pedophiles in Malones story, admitted to a therapist what was wrong, she just became extremely cold and harsh, he told Malone. She even, a few times, almost got to the level of shouting. She ended up telling Adams mother.

There is a huge reason [pedophiles] would avoid therapists and doctorsthose people have an obligation to report them to police if they think children might be in danger in the future, said Ethan Edwards, one of the co-founders of the Virtuous Pedophiles, who uses a pseudonym.Especially if they are not specifically trained in the issue, and with the common belief that all pedophiles molest children sooner or later, it is very perilous for a pedophile to seek out a therapist.

Watch more from VICE:

Christoffer Rahm, a psychiatrist, researcher at the Karolinska Institute, and the senior author on the JAMA study from April, once worked at a clinic linked to a Swedish national helpline focused on sexuality, PrevenTell. Rahm ended up meeting some pedophiles who called in; one was a bus driver who brought children to school. The bus driver was struggling with his impulses and fantasies, but had not sexually offended in any way. Rahm looked for research to help determine the best treatment for his patient and found a gap in the literature: There were no rigorous comparisons of different medications, or recommendations about who might do best with therapy. (As far as we know, female pedophiles are rarer, and the research on treatment for them even more sparse.)

Cantor feels it's more than just a gap when it comes to pedophilia. It is a black hole, he said. This is a topic that scientists in the fields of mental health are not just uninterested init is actively repugnant."

Thats what motivated Rahm to conduct his study. If there are people seeking help for this, the best thing would be to manage it in a preventative phase before the damage is done, he said. Of course, society needs to say that any kind of abuse against a child is not okay. But it is counterproductive if these people can't even seek help with a professional.

The medication Rahm studied is Degarelix, approved by the FDA in 2006 for treatment of advanced prostate cancer. This is the first time that it's been used off-label for pedophilia. Its an injection that starts working right away and lasts for about three months. It works by shutting down signals from the brain to the body to produce testosterone.

In qualitative interviews Rahms team did during the study, they found that some of their participants experienced positive effects. They described feeling an inner calm, Rahm said. They felt less pressure, that they had a better intimate life with their partners. Some described that the annoying thoughts around children disappeared so they can focus on other things. And many described that they had lost that enervating impulse to masturbate, and were able to see children as just human beings and not sexual symbols. A majority of the participants in the group that got the active drug said that they would want to continue taking it.

Many of the therapies that have been used for pedophiles have not been validated this way, but deployed through forensic psychology and the criminal justice system. Though Berlin has prescribed hormone-reducing medications to countless patients, he feels that the legal system usually doesnt collaborate with doctors and scientists who are studying the use of these drugs. As a physician, I think that's completely inappropriate, he said.

If someone goes to prison being sexually attracted to children, theres nothing about prison that can get rid of that attraction, or enhance a persons ability to resist temptation later on, Berlin said. It also leads to a mistrust of treatment, because of a history of involuntary use of chemical castration and aversion therapya therapy that associates negative cues with images of young children to dissuade future attraction.

The idea that we can solve this simply through punishment and incarceration is very naive, Berlin said.

Talk therapy should focus on managing a person's sexual interests, with an explicit acknowledgment that those interests will likely never change. In the past, therapy sometimes focused on searching for trauma, because of the belief that a history of abuse led someone to abuse. The truth is a bit more complicated. Having been sexually abused in your own childhood could be a factor in committing sexual abuse as an adult, but is not necessarily a factor in pedophilia.

This is what Ive heard over and over, Cantor said. They knew. They always knew it. All their past therapists were telling them to focus on trauma, what happened in their childhood. But their genuine experience of it was that they were born this way.

We need to move on to the next generation of research and quality development.

Cantor said that once that basic framework of therapy changes from changing ones sexuality to managing it, people adapt very quickly. It makes more sense to his patients, and theyre able to better commit. If a person has looked at child porn or committed sexual abuse in the past, a therapist would help them examine how and why their self-control broke down, and how to set up their life so that it doesnt happen againnot how to stop being attracted to children.

For some people, this process could be paired with sex-drive reducing drugs. Some people find they would rather live in that state than with those nagging sex drive that they can't express and can do anything to do anything about, Cantor said.

Yet even in those states that have issued mandates for sex offenders to receive hormone-reducing drugs as punishment, it can be incredibly difficult for non-offending pedophiles who want it to get medication. I get letters from people around the country all the time wanting access and they can't even get access to it, Berlin said.

Rahm doesnt advocate for medication to be used for every pedophile for lifehis study explores whether this specific drug could help. He said a person may only want and need it for a few months. It could help a person through a difficult time, or be combined with the start of a behavioral therapy practice. We need to move on to the next generation of research and quality development, Rahm said. We need to evaluate our treatments and to get evidence-based treatments out there so we know what we're doing.

The word castration has a dark history, and dark connotations. It's often been wielded involuntarily: In Germany the number of involuntary castrations of sex offenders increased as a result of the Nazi German Act, with at least 2,800 sex offenders were castrated between 1934 and 1944. In the United States, Black men accused of raping or sexually assaulting white women could find themselves subject to castration. For reasons like these, Rahm is torn about calling Degarelix chemical castration." While he thinks researchers and clinicians should accurately describe what the drug is doing and its side effects, he worries that referring to it as castration could scare people away, or disregard the consent and autonomy of patients who want it.

Rahm said that every person who participated in their study did so voluntarily, and was informed in detail about any possible side effects from taking Degarelix. They had the option to quit the study at any moment. Hes also currently running another placebo-controlled study on a non-pharmacological option: therapy geared specifically towards pedophiles that they can access anonymously, through the dark web.

The mere existence of Rahm's studies is important, outside of the details of the findings. Doing placebo-controlled studies on pedophilia was previously thought to be impossible, because of the ethical implications of not giving an active treatment to a group of people attracted to children.

In Brikens editorial, he wrote that because the medication they used was fast-acting, and they allowed anyone with pedophilia into the studynot just those who were high-risk for offendingit helped make the placebo group ethically possible. Briken concluded that Rahm's study was the most important contribution to the field of pharmacotherapy of pedophilic disorders since the original study of hormone reducing drugs in 1998, and offers a starting point for a more comprehensive approach to pedophila treatment.

In Germany, Prevention Project Dunkelfeld, which offers therapy and medication, has 10 locations throughout Germany, and a person can get help while remaining completely anonymous.

The demand for their work is high: After a BBC documentary on the Dunkelfeld Institute aired, the Guardian reported that Dunkelfelds hotline was overwhelmed with calls from British pedophiles. One British man was so desperate, he moved to Germany to be able to access a Dunkelfeld programme, the Guardian wrote. In an email exchange with the Guardian, the man, who wished to remain anonymous, wrote: 'So far, all I have ever received from the NHS is doors slammed in my face.'"

There's not as well-known a center for pedophiles in the U.S. to go to. Richard Kramer, the educational director at B4U-ACT, an online community for pedophiles, said he figured out he was attracted to pubescent boys in his 20s. (His attraction is to boys around the age of 12 or 13, which is technically called hebephilia.) I was very ashamed about it and thought that I was seriously defective as a human being, Kramer said, who is using a pseudonym. I really wasn't able to find any information about it. I didn't want to go to the library for fear that people would see what I'm looking up.

When he began reading information online, he said, everything he encountered was very negative. It said that I would be a monster, I would have hundreds of victims, and that my entire life would be centered around an elaborate plot to deceive parents and to manipulate children into abusing them, he said. So I thought, well, this is what they think about me. I have no interest in seeing them and seeing a therapist.

A big part of being successful in therapy is having the support of family and friends, something that pedophiles can lack. They often are going through difficult treatments alone, and are unable to talk about it to others. You cant tell co-workers, or ask a boss for time off for your appointments. You have two choices, said Michael Seto, a forensic psychologist and sexologist at the University of Toronto. You don't do it or you lie about it.

When Kramer was ready to look for a therapist again, he didnt really care what kind of approach they used, but was more concerned about whether they understood enough about pedophiles to not treat him like a criminal. His goals didn't involve a struggle to control his impulses, but to manage the shame and sense of isolation from others because he couldnt be honest.

We have to insist that people who have this orientation not act upon it, Berlin said. If we think about that, that can be quite a burden. Its not surprising that some of these folks might be in need of mental health assistance, because of the effect of experiencing these attractions on their sense of self-esteem and self-worth.

Happy, mentally healthy people do not molest children.

Some pedophiles are attracted to adults and children; some, only children. For those who are exclusively attracted to children and dedicated to non-offending, Kramer said, there needs to be a space for helping them grieve over not being able to have romantic and sexual relationships. How do they deal with loneliness? he said. There are other concerns, some almost mundane: How, for instance, do they deal with answering questions friends and co-workers ask about their personal lives? Hes had friends who asked him if he was gay, and he said he wasnt sure how to answer.

I'm not exactly gay, but I'm definitely not straight and I'm definitely not asexual, he said. How do you respond to that?

Gary Gibson founded the ASAP as one potential solution to this problem. Through an involvement with the Association for the Treatment of Sexual Abusers (ATSA), Gibson has been curating a list of therapists to whom he can refer pedophiles. The list is now around 400 names long. ASAP primarily focuses on non-offending pedophiles, but they will also help people who have offended and want to stop. People are just desperate out there, Gibson said.

He has worked with pedophiles who were so desperate for help that they underwent physical castrations. One man traveled to Mexico to have the operation done; when he returned, he tried to find a doctor to supervise his recovery and medications. I could not find a doctor who would take him on, Gibson said. They didn't want him in the office. I did find a therapist to work with him, and I kind of lost contact with him. Im worried about what happened to him.

Until recently ASAP has been handled almost entirely by Gibson, but ASAP is currently undergoing a significant expansion. It has increased its office and volunteer staff, is making a new, online database of mental healthcare providers, and creating a 24/7 helpline. Gibson said his dream is to get a multimillion dollar grant to create a mentor program for teenagers, aged 13 to 17, who are learning that theyre pedophiles. Ive applied three times, he said. Maybe the third time's the charm, because Ive been denied twice.

The goal is to help every non-offending person attracted to children find therapy if they want or need it, said Robert Hillman, a lifelong virtuous (non-offending) pedophile, and the new president of ASAP. Hillman said that the mantra is: All pedophiles are born non-offending, and the aim is to help keep it that way. Happy, mentally healthy people do not molest children," he said.

People do the most desperate things when they feel the most desperate, Cantor said. A lot of what these groups and therapy provide is helping people lead a life that is worth protecting. When they have a life worth protecting, thats when people get the energy and the willpower to control themselves, because they dont want to risk the life that they have.

What Hillman and Gibson want is the opportunity for any person attracted to children to chart their own path, and figure out what works best for them. That may include an experimentation with medication, and it may not. ASAP doesnt control their therapiststhey all operate independently, using different methods of treatment. They're not always successful. One guy has committed suicide that I know of, Gibson said said. But I think that we have probably saved a few lives and saved many children from being abused.

These support groups and therapy networks are providing a lifeline, but alone, they don't guarantee a consistency in treatment, nor fill the gaps in the scientific literature when it comes to which treatments might be best for a certain person. There might be certain hormone-reducing medications that are less risky or work better than others; certain pedophiles that fare better without drugs; certain therapeutic practices that are more helpful than others. Those answers aren't clear-cut.

As with all medications, some people have good experiences and others do not. Pedophiles can identify as ego-dystonic or ego-syntonic. Ego-syntonic people consider pedophilia as part of their identity, and can be okay with fantasizing and masturbating about children (though not with porn), while ego-dystonic people are not. It may be that treatment should be different with those who have different attitudes towards their attraction, even if members of both groups have the same commitment to not offend.

After about five weeks, Parker said that he felt better from the medication he had ordered online. It was night and day," he said. "I can't tell you what a weight was lifted off of me, or a pressure from under me that was relieved. Whenever I think about it I just lay back in my chair and breathe a contented sigh, knowing that I won't suffer like that again. Both physical urges in my body and intrusive imagery in my mind have disappeared."

He doesnt think that medication should be thought of only as a stop-gap to a person committing sexual abuse. Offending was never a danger for me in the first place, he said. He doesnt take the medication to stop himself from molesting a child, but as a way to improve his quality of life.

When Max Weber, who helps run a peer-support website for pedophiles in Germany, realized his attraction to young girls in his early 20s, he said, he was terrified. My picture of pedophilia at the time was the same wrong impression most parts of society have: that pedophiles were bound to offend, he said.

Weber got treatment at Dunkelfeld, and said he views medication like a pair of eyeglasses. You can put [them] on to help yourself focus on things that you want to change about your life.

To Weber, pedophilia was like being surrounded by deep water; he had to struggle to stand on his toes to avoid drowning. I needed all my strength to cope with it and dont drown in my own fears and self-hate, he said. As a result sexual impulses felt very powerful since, when you are standing on your toes, even the slightest push could throw you over.

He took medication for about nine months. During that time when his sexual feelings were repressed, he regained a foothold on his life, he said, and found that even without medication he is able to be around children without issue. I now know that I am in charge, and no one can make me offend other than myself, he said.

Two years ago, David, a 22 -year-old recent college graduate from New York and a volunteer for a peer-support group including pedophiles, desperately wanted to take hormone-altering medication. I hated myself for having feelings about children, and I just wanted to be like everyone else," he said. "I was also going online and finding articles about how to raise libido, and doing the opposite of all of the advice I found. But I couldnt find a therapist I felt safe coming out to.

Since then, he said that support groups like Virtuous Pedophiles have helped him realize that being attracted to children is not something he chose, and hes not tempted towards any illegal behaviors. In the end, there was no need for me to go through such a treatment with dangerous side effects," he said.

Though he never ended up trying medication, David thinks his experience with peer support reveals something important. Medications can help reduce physical symptoms, he said, but the restthe support, the isolation, the shameall needs to be addressed outside of just taking a pill.

I struggled with serious depression, anxiety, and self-hatred as a teenager starting to understand that I was a pedophile, David said. Becoming less isolated, having people to help when I was hurting, and being able to help others in the same way is what brought me back from that.

Hillman was a patient of Berlins about 25 years ago. I was on the brink of madness from the desires and from the shame and self-hatred and loathing, he said. "It was crushing me and I was not going to survive it. He took hormone-reducing medication with Berlin's help, and said that combined with therapy, it saved his life. Since I was at that time and have always been non-offending, my anti-androgen therapy was not mandatory in any way and thus I started and stopped it several times, because of the affordability issues, Hillman said. But I can attest that the medication did reduce my thoughts and therefore some of my distress.

Then he found the Virtuous Pedophiles group about one year ago, and the support hes culled from the others there has given him a new gusto for life, without medication. Now I am dedicated to living. And I am dedicated to making sure no one else has to waste their life just to be virtuous, he said.

Hillman said that these narratives reveal how all pedophiles are different. Some will benefit from meds and some will not, he said. Some are against medication, some are not.

Rahm hopes to continue studying treatment options for pedophilia, in a rigorous way. In his view of a forthcoming modern pedophile treatment, each person would get an individual assessment and be offered an evidence-based treatment. It would work with helping a pedophile address both their personal feelings and concerns, and also their risk of offending.

In my vision, some people need therapy, some need medication, some need both, and some won't have any effect on any of these. They need something else, Rahm said. This is nothing novel or groundbreaking, he added. I would just like to apply modern psychiatric thinking to this group.

Follow Shayla Love onTwitter.

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Pedophilia Is a Mental Health Issue. It's Still Not Treated as One - VICE

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the In-vitro Diagnostics (IVD) market.

Trusted Business Insights presents an updated and Latest Study on In-vitro Diagnostics (IVD) Market 2019-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the In-vitro Diagnostics (IVD) market during the forecast period (2019-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ In Vitro Diagnostics Market Size, Share & Industry Analysis, By Product Type (Instruments, Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Point of Care, Hematology and Others), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, Others), By End User (Clinical Laboratories, Hospitals, Physicians Offices, Others) and Regional Forecast, 2020-2029 (Includes COVID-19 Business Impact)

The global in vitro diagnostics market size was USD 61.22 billion in 2018 is projected to reach USD 87.11 billion by 2026, exhibiting a CAGR of 4.5% during the forecast period.

We have updated In-vitro Diagnostics (IVD) Market with respect to COVID-19 Impact.Inquire before buying

IVD are medical devices and accessories used to perform tests with the help of samples such as blood, urine, and tissue to help detect infection, prevent disease, monitor drug therapies and diagnose a medical condition.In vitro diagnostics industry is consolidated in nature and demonstrates increasing adoption rates of diagnostic devices along with use of IVD instruments in clinical laboratories and hospitals. The industry has perceived significant developments over the recent years. Introduction of new techniques for rapid and fast disease diagnosis are anticipated to surge the demand for in vitro diagnostic services, subsequently, driving business growth during the forecast period.The market is anticipated to witness the growth owing to technological advancements in healthcare, improved and efficient diagnostic tools, and increased availability of over the counter tests. Increasing demand for advanced, personalized and rapid diagnostic system is anticipated to propel the market.Additionally, increased funding by government and other organizations in the healthcare sector is one of the factors likely to boost the global market during the forecast period. Various initiatives undertaken by the government to provide information and education on personalized medicine and IVD tools for effective patient management is anticipated to drive the in vitro diagnostics market growth.

MARKET DRIVERS

Rising Prevalence of Chronic and Infectious Diseases to propel the Global Market.The rising prevalence of infectious diseases, leading to increasing demand for disease diagnosis is one of the factors anticipated to propel the market growth. According to the National Institute of Health (NIH), in 2017, around 23.5 million cases of autoimmune diseases were reported in America and this is expected to increase in the forthcoming years.Additionally, increasing prevalence of cardiovascular diseases in developed and developing countries is one of the major factor driving the growth of the in vitro diagnosis. For instance, according to U.S. Department of Health & Human Services, around 735,000 Americans suffer from a heart attack every year. Additionally, as per the Heart Disease and Stroke Statistics, 2019 Update from the American Heart Association, around 116.4 million, or 46% of the US adults are estimated to have hypertension. The increasing number of patients suffering from cardiovascular diseases is likely to increase the demand for the in vitro diagnostics tools, subsequently propelling market growth.The rising consumption of tobacco and alcohol, adoption of a sedentary lifestyle, unhealthy dietary habits, etc. are the major factors responsible for increasing prevalence of chronic diseases. The rising prevalence of the chronic disorders is likely to increase the demand of the in vitro testing.

Increasing Use of Point-of-care (POC) and Technological Advancements in IVD Tools to Drive the In Vitro Diagnostics Market.

Increasing adoption and demand for point-of-care (POC) devices is expected to fuel market growth. Additionally, the introduction of advanced technologies, such as biochips and nano-biotechnology, and miniaturization of microfluidic tools is likely to boost the demand for point-of-care (POC) devices. These advanced techniques have facilitated easy access to point-of-care diagnostic tests and offer quick and valid test results, thereby fueling the demand for in vitro diagnostic instruments . These factors are subsequently anticipated to drive the growth of the market during the forecast period.

For instance, In June 2019, Abbott launched, Afinion HbA1c Dx assay, its first rapid point-of-care test for diagnosis of diabetes among general population. The increased investment by key market players in the development of technologically advanced and rapid testing devices is likely to drive the growth of the market.Recently, adoption of rapid and accurate tests for diagnosis of infectious diseases and other chronic diseases is driving the market. In March 2018, Sekisui Diagnostics announced the launch of Silaris point-of-care (POC) for the diagnosis of infectious diseases. Such product launches will shift the patient preference from traditional diagnostic tools towards advanced IVD services.

SEGMENTATION

By Product Type Analysis

Reagents & Consumables Segment to Generate the Highest Revenue

As with the help of advanced technologies and rapid diagnosis, the in vitro diagnostics market is anticipated to grow at a faster rate. Increasing prevalence of chronic and infectious diseases, is projected to fuel the demand for diagnostics tools, that is projected to drive the growth of the market.

Reagents and consumables segment dominated the product type owing to their high usage in the in vitro diagnosis. Increased number of research and development activities for the diagnosis of chronic diseases is one of the major factor fueling the demand for reagents and consumables.

Rising demand and adoption of the self-test and point-of-care devices will subsequently increase the demand for these products. An increasing number of IVD tests is one of the major factors driving the growth of the reagents and consumables segment.

The instruments segment is expected to grow at a slower pace. Technologically advanced instruments and introduction of rapid testing tools are some of the factors propelling the segment growth. For instance, in April 2018, Altona Diagnostics GmbH, launched a CE-IVD marked AltoStar Molecular Diagnostics Workflow. It is a flexible and efficient automatic system that automates the entire workflow from sample preparation upto analysis.

By Application Analysis

Oncology to Exhibit a Significant CAGR During the Forecast Period.Infectious diseases dominated the application segment and is anticipated to exhibit lucrative growth over the forecast period. Rising prevalence of cardiovascular diseases such as coronary artery disease, arrhythmias, and stroke globally is likely to increase the demand for IVD tools. These factors are expected to drive the growth of the cardiology segment subsequently, which will boost the in vitro diagnostics market.

Oncology segment held a substantial share and is projected to witness significant CAGR during the forecast period. Availability of advanced home care kits such as fecal occult blood test (FOBT) for diagnosis of colon cancer in homecare settings is one of the major factors likely to drive this segment.

The increasing prevalence of infectious disease and cancer are major factors boosting the demand for in vitro diagnosis. Increasing investment by research institutes and key market players in the development of the rapid and easy in vitro testing tools in the oncology is one of the major factor propelling the growth of the oncology segment.

By Technique

Immunodiagnostics to hold a Leading Position in the Market

The various techniques used in IVD are immunodiagnostics, clinical chemistry, molecular diagnostics, point-of-care, hematology, and others. The immunodiagnostics segment accounted for the largest share in the market.Rising prevalence of chronic and infectious diseases and rising need for early diagnosis are some of the primary key factors attributed to the growth of the technique segment. Molecular diagnostics is expected to grow at a significant CAGR during the forecast period. This technology facilitates early detection of cancer, infectious diseases, and genetic disorders by using genetic technologies that helps in the detection of abnormalities in the prenatal stage.Clinical chemistry segment accounted for the second-largest share in the technique segment. Attributing to various applications of clinical chemistry, including detection of hormone fluctuations and blood glucose levels is anticipated to propel the segment growth. Point of care segment is anticipated to grow at a significant CAGR during the forecast period owing to increased demand for the point of care testing diagnosis. The demand for rapid and accurate diagnosis globally is one of the major factor likely to accelerate the segment growth.

By End User Analysis

Clinical Laboratories to Hold the Highest Share.Followed by clinical laboratories, hospitals are anticipated to hold the second-highest global market share. High demand for IVD tests as a result of increased in hospitalization is one of the factors propelling their use in the hospital segment.

Increasing demand for biosensors, pregnancy kits, and glucose meters to ensure quick and accurate results are some of the major factors propelling the growth of the physicians offices segment at a faster rate.Increasing incidence of cardiac diseases and diabetes and the rising prevalence of infectious diseases in developing countries are the major factors driving the demand for point-of-care tests. The growing use of point of care devices within hospitals and physicians office, especially in remote and rural areas, is also fueling the demand for point of care tests and subsequently driving the growth of the hospitals and physicians office segments.

REGIONAL ANALYSIS

North America generated a revenue of USD 23.09 billion in 2018 and is anticipated to emerge dominant in the global in vitro diagnostics market during the forecast period. Adequate and favorable government regulations, well-established diagnostic infrastructure, adoption of technologically advanced diagnostic techniques, and presence of prominent key market players in this region are some of the significant factors anticipated the drive the market in North America.

Asia Pacific is expected to grow at a significant CAGR during the forecast period. Increasing prevalence of cardiovascular diseases and infectious diseases and rapid development in the healthcare infrastructure of developing countries such as India and China is anticipated to rise the demand for the IVD tools. These factors are expected to subsequently drive the market growth in the Asia Pacific at a faster pace.

On the other hand, Europe is projected to witness significant growth in the global market. The high-income countries, including Germany U.K., and Spain, are anticipated to contribute to the growth of this market in the region. Rising healthcare expenditure and increasing adoption of POC testing devices are some of the major factors driving the growth of the market in Europe.

The Middle East and Africa is anticipated to register high growth in the market owing to the technological developments, rapidly expanding hospital infrastructure, and entry of global players in the region through direct and indirect presence. The region is significantly heading towards the modernization and technological developments. Latin America is also expected to grow at a significant CAGR during the forecast period.

INDUSTRY KEY PLAYERS

F. Hoffmann-La Roche Ltd, Abbott Laboratories, Thermo Fischer Scientific Inc., and Siemens Hold Dominant Shares by Providing IVD Tools

The top key market players focus on strategies, such as mergers and acquisitions, collaborations, and new product developments and launches to strengthen their market position globally and increase their market share. For instance, in August 2018, Sysmex Corp. and JVCKENWOOD Corp. jointly established a new manufacturing company Creative Nanosystems Corp. to develop and manufacture bio-devices. These strategic collaborations strengthened the companys product portfolio and reinforced its market position.

Siemens Healthcare is one of the most significant market players in the healthcare industry and major player in laboratory diagnostics, medical information technology, and medical imaging. The diagnostics division of the company includes products for clinical chemistry, drug testing, hematology, coagulation, immunoassay, infectious diseases, molecular diagnosis, point of care testing and many others. Having a strong product portfolio and supply chain makes the company dominant in the market. Siemens Healthcare, Abbott Laboratories, F. Hoffmann-La Roche Ltd, and Thermo Fischer Scientific Inc., hold a dominant market share by providing a wide range of tools for the disease detection and analysis.

IN VITRO DIAGNOSTICS MARKET COMPANIES:

REPORT COVERAGE

A growing trend observed in the penetration of the in vitro diagnostics market across the industries.The report provides qualitative and quantitative insights on the global market and detailed analysis of market size & growth rate for all possible segments in the market. Along with this, the report provides an elaborative analysis of the global market dynamics and competitive landscape. Various key insights presented in the report are the price trend analysis, recent industry developments such as mergers & acquisitions, the reimbursement policies, SWOT analysis, and key retail industry trends, competitive landscape and company profiles.Report Scope & Segmentation

Segmentation

By Product Type

By Technique

By Application

By End User

By Geography

Looking for more? Check out our repository for all available reports on In-vitro Diagnostics (IVD) in related sectors.

Quick Read Table of Contents of this Report @ In Vitro Diagnostics Market Size, Share & Industry Analysis, By Product Type (Instruments, Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Point of Care, Hematology and Others), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, Others), By End User (Clinical Laboratories, Hospitals, Physicians Offices, Others) and Regional Forecast, 2020-2029 (Includes COVID-19 Business Impact)

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Global in vitro diagnostics market size was USD 61.22 billion in 2018 is projected to reach USD 87.11 billion by 2026, exhibiting a CAGR of 4.5%...

Although one can surmise the name of the lead character (Grazyna Misiorowska) in Maryoaround, it takes some time for her ever to be bothered to speak it aloud, staying largely anonymous as she works in a minimart in Poland. Shes led a quiet life, devoting herself to the lord so thoroughly that shes prone to carrying a Virgin Mary in her purse and longingly looks at the nuns that walk across the courtyard of her apartment building, though director Daria Woszek and co-writers Sylwester Piechura and Aleksandra Swierk are careful not to ever go into why she didnt ever join the ministry herself, reaching 50 without incident as a trip to the doctor reveals that shes never needed contraceptives nor will she ever now that shes hit menopause.

Still, life is only beginning for Mary when her physician recommends some light hormone therapy drugs to ease her into a new phase of womanhood, and similar to another recent Polish breakout, Agnieszka Smoczynskas lavish musical The Lure, that dabbled in the fantastical to express the frenzy of coming of age, Marygoaround inventively summons the fear and excitement of her increasing sexual consciousness. Filled with bold colors and a murderously deadpan sense of humor, the dark comedy sees Mary start to behave in ways that she only has read about in the trashy romance novels that have been brought home by her niece Helena (Helena Sujecka), who stops by for her birthday and seems to never leave thereafter.

Youve always impressed me with this composure of yours, says Helena, who typically wakes up hungover after partying the night away and cant possibly imagine her aunt indulging in the same behavior. Yet she cant help but notice that the drugs that Mary has begun taking has some side effects (perhaps emanating from the unpronounceable ingredients she sums up as horse piss) and after Mary quite literally closes the door on Jesus, not wanting to be spied upon by the portrait in the hallway of her flat as she gets frisky in her bubble bath, all bets seem to be off.

Woszek playfully finds all sorts of amusing expressions of this sexual awakening, with the wonderfully stone-faced Misiorowska breaking character to gorge on caviar for the first time as if shes having an orgasm to watching the impossible gyrations of dancers clowning in Rize and appearing as if the contortions going on in her mind are even more impressive. Whether Mary will ever find the confidence to act on her desire to bed her boss, a western-wear aficionado who appears to be as lonely in the archetypal life he adopted as she is in hers, becomes the films slender narrative thread, but the thrills to be found her self-discovery are more than enough, particularly when the film fully explores the idea of chaos commencing when she allows a man to enter her home. All of it is a bit cheeky, as it should be, but theres always something real behind it, whether its Marys growing awareness of her power or the considerable craft of Woszek, production designer Alicja Kazimierczak and cinematographer Michal Pukowiec, who make the world come alive with evocative lighting and sets as much for an audience as it does for Mary.

Marygoaround will screen once more at Fantasia Fest on August 31st at 5:30 pm EST, available digitally to Canadian audiences.

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Fantasia Fest 2020 Review: Menopause Leads to a Turn for the Better in Daria Woszek's Frisky Marygoaround - The Moveable Fest

Most people think of shingles as a rash, but thats only the tip of the proverbial iceberg. Sure, its painful and downright disturbing to look at, but thats nothing compared to the number shingles can do on your nerve cells if you dont deal with those oozing, angry blisters immediately. Weve got the doctor-approved scoop on what to look for when it comes to shingles, plus how to avoid the uncomfortable scenario altogethertheres a vaccine for that!so you can return to your regularly scheduled program.

Think of shingles as that cousin you kinda sorta remember from childhood but havent seen in years. Then suddenly one day, she shows up on your doorstep and gets all territorial, hanging around and wreaking havoc on your very existence. She may have been annoying when you were younger, but now shes downright mean. Shingles is that grown-up cousinthe adult version of chickenpox that you vaguely remember from your childhood.

Weird but true: You cant get shingles unless youve first had chickenpox, as the virus that causes the former must be introduced into your system by the later. Heres what happens. Chickenpox is caused by varicella zoster, a virus that takes up residence in the roots of your nerve cells. Once the pox outbreak is over, the virus doesnt leave your bodyinstead it hibernates in those nerve cells. Then, decades later it can wake up and cause shingles (known as herpes zoster in this second phase). Since 98% of Americans over the age of about 40 have had chickenpox at some point, that means they are carrying the virus that causes shingles. Creepy, no?

If youre young enough to have had the varicella vaccine that prevents chickenpoxits been available for about 25 yearsyou should never have to worry about contracting shingles either. It will take a few more decades to say for sure, however, because we have to see what happens when the vaccinated population reaches the age when they become vulnerable to a shingles outbreak.

Meanwhile, one million people in the United States who are too old to have been vaccinated for chickenpox develop shingles each year, usually after age 50. Close to one in three people will get shingles in their lifetime, and that increases to 50% of people who live to age 85. Shingles gets its name from the thick band of blistering rash that literally looks like a shingle on a house. Shingles usually occurs on your torso, often in a belt-like pattern around the midsection, but it can show up anywhere on the body.

For most people, shingles resolves in three to five weeks with treatment and no further complications. About 20% of the time, however, it progresses to serious nerve damage and chronic pain in the area where the rash was, a complication known as postherpetic neuralgia or PHN. The older you are when you get shingles, the higher your risk of PHN, which can be so debilitating that it results in depression, anxiety, sleep deprivation, weight loss, and difficulty with daily activities. If shingles occurs on the face or head, it can seriously impact your vision, andrarelycause hearing loss, facial paralysis, and swelling of the brain.

So weve established that you have to have the chickenpox first, but not everyone who had chickenpox is destined to get shingles. What makes the virus spring back to life in some people and not others? Scientists have been trying to figure that out forever and the only thing we know for sure is that the virus takes advantage of a weakened immune system to reassert its presence. For that reason, folks with a weaker or compromised immune system are at a higher risk. That includes:

Anyone over age 50. Our immune system gets sluggish and less effective at protecting us as we age.

People with certain medical conditions. People with cancer, HIV, autoimmune disorders, and organ transplant recipients are more vulnerable to shingles because the conditions themselves drag down immunity, and they often require treatment with medications that further suppress it.

People under chronic daily stress. The death of a loved one, divorce, or job loss are highly stressful eventsand can raise your risk of getting shingles. Why? Because stress causes the body to produce copious amounts of the hormone cortisol, which lowers the effectiveness of your immune system. Physical stress can also be a factor, and your odds of developing shingles is higher when your body is fighting another type of infection, or if you have an injury that irritates a nerve in which the virus is hanging out.

Shingles is also not contagious in the traditional sense: Its not airborne so you cant cough or sneeze it onto someone, or transmit it via saliva by sharing food or drink. It is possible to transmit it if someone who never had the chickenpox (or the vaccine) makes direct contact with the fluid in the blisters.

Thats going to be pretty rare though because the vast majority of the population has had either the virus or the chickenpox vaccine. And even if it happened, the unprotected person who touched the blisters would get chickenpox, not shingles. The bodys first exposure to the virus always causes chickenpox, and shingles is the consequence of the virus reactivating later on.

Given that this virus is painful, and that the complications from it can be significant, its natural to want to keep an eye out for any early indications that you could have shingles. That may prove trickier than youd think, since the signs and symptoms of shingles can vary: The pain may be mild or severe, and some people have mostly itching while others have intense sensitivity to even the gentlest touch, such as the weight of sheets on a bed.

Shingles does, however, follow a fairly predictable pattern if you know what you are looking for. In fact, doctors usually diagnosis it simply by sight. Common symptoms of shingles include:

The key to recognizing shingles is not just the list of symptoms, but the very specific pattern they follow. In fact, you can usually feel some shingles symptoms before you see themand your chances of a full recovery are better if you do. Heres how the illness unfolds, usually over a period of three to five weeks.

First, you experience the sensation of burning, tingling, numbness, itching, or sensitivity in a patch of skin. It may feel like theres a cut or burn on the skin even though it still looks normal. Some people also have flulike symptoms such as fatigue, headache, fever, or upset stomach.

Between one and five days later, an angry, painful rash made up of small red spots will appear at the same site.

After a few more days, the rash turns into fluid-filled blisters that weep or ooze.

About 7 to 10 days later, the blisters dry up and crust over.

In a few more weeks, the scabs disappear.

The other big hint that youre dealing with shingles is that everything happens in one patch of skin on one side of the body. Docs call these patches dermatomes: An area of skin that is supplied by a single nerve coming out of the spine. Your body has 31 such spinal nerves between your neck and the tailbone, each of which run horizontally from one side of your spine around to the front of your body, without ever crossing the midline. For that reason, you wouldnt get a shingles rash that starts on, say, the left of your waist and spreads across to the right side of the waist. The rash is always going to stop by the mid-point of your abdomen or back (where the nerve terminates or begins).

The primary job of these nerves is to send sensations like pain or itching to the brain, but when the virus become active and disrupts the signal, the nerves overreact and cause all the discomfort that accompanies the rash. Usually all this happens on the torso, but shingles can occur anywhere. The face is the second most common area for shingles to appear.

The short answer? As soon as possible. Any type of board-certified primary care physician (family physician, internal medicine, geriatrician) or a dermatologist can diagnose and treat shingles. The really important thing is that you want to get an early diagnosis, ideally before you even see the rash. Thats because the antiviral medications used to treat shingles are significantly more effective if taken within 72 hours of the rash appearing.

So focus on getting an appointment quickly. Dont worry about not being able to see a rash yetthese pros typically treat several cases of shingles every week and will not think youre a hypochondriac when you describe an unpleasant sensation without anything to show for it. The shingles presentation is so textbook predictable that they know exactly whats coming next.

If you miss that 72-hour window, dont panic. After that point, an antiviral may still help if new blisters are continuing to appear. Also, antivirals can help the blisters dry up faster, limit your pain during the illness, and lessen the chances that you will develop PHN.

The bottom line: Its entirely possible that 20 years from now, the chickenpox vaccine will make shingles obsolete. But for right now, the best thing you can do if youre 50 or older is the get the shingles vaccine. There are plenty of unpleasant conditions out there that youll be faced with as you get older. If you can eliminate one painful illness from the mix, why wouldnt you?

See the rest here:
Let's Talk About Shingles Signs and Symptoms - HealthCentral.com

The skin is often a window into what's going on in the bodyincluding the immune system, which can regulate inflammation and affect the barrier function and microbiome of the skin.

"Recent research has highlighted that the immune system influences the types of microorganisms that live on your skin and affect your risk for disease," says Keira Barr, M.D., holistic and board-certified dermatologist. "So when the immune system is weakened, it can show up on the skin as eczema; allergic reactions; poor wound healing; bacterial, fungal, and viral infections such as herpesand, depending on how weak the immune system is, the area affected could be localized or widespread."

Skin symptoms related to the immune system could be manifesting for a number of reasons. For example, a poor diet and stress, which can cause immunosuppression and make your skin more vulnerable to problems, says Barr.

Try this: Address these issues at the skin level and from within. Using gentle, unscented personal care products including cleansers and detergents, and keeping skin moisturized, can help support a healthy skin microbiome. Taking steps to reduce stress and improve your diet will also help support the immune system and boost the skin's ability to be resilient.

Read the original here:
8 Signs You May Have A Weakened Immune System & What To Do About It - mindbodygreen.com

From birth control to menopause, when it comes to womens health, Dr. Eric Feinberg, an OB/GYN with Lee Health, says its important for patients to address any and all medical concerns with their physician. Its important to provide a safe comfortable, nonjudgmental environment. And I find that although initially, its probably a little uncomfortable, its almost as if a flood gate opens up of relief once they realize that they are in a safe place.

OB/GYNs can educate their patients on the benefits of hormone therapy, birth control, and sexual health. One of the most common things Ill see is pain related to sexual activity. There should not be a pain. Pain can be a hallmark of something minor, such as an infection. It can be the hallmark of something more major such as endometriosis or scar tissue, so theres a lot of different things so evaluating that pain whats the underlying cause, how do we get past it, and how do we get to a sexually satisfying life, said Dr. Feinberg.

Regular visits with your gynecologist can also help to prevent diseases, infections, and screen for certain cancers. Cervical cancer should be almost preventable if its screened at the correct interval, we do breast cancer screening as well, making sure mammograms are done at the appropriate time, he said.

Helping women address any medical concerns while educating them on how to protect their overall health.

View More Health Matters video segments at LeeHealth.org/Healthmatters/

Lee Health in Fort Myers, FL is the largest network of health care facilities in Southwest Florida and is highly respected for its expertise, innovation and quality of care. For more than 100 years, weve been providing our community with personalized preventative health services and primary care to highly specialized care services and robotic assisted surgeries. Lee Health Caring People. Inspiring Care.

Visit LeeHealth.org

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Health Matters: The Role of a Gynecologist - NBC2 News

Waking up at night to urinate is by far the most bothersome lower urinary tract symptom, wrote Gopal H. Badlani, MD, in an editorial for Urology Times.1 He further added that nocturias impact on quality of life and health is profound. In this interview, Badlani spoke with Jeffrey P. Weiss, MD, PhD, who discussed how he defines nocturia, how to separate the symptom from

overactive bladder, and how he conducts patient work-ups for nocturia. Weiss is professor and chair of urology at SUNY Downstate Health Sciences University, Brooklyn, New York. Badlani, an editorial consultant for Urology Times, is professor and vice chair of urology at Wake Forest Baptist Medical Center, Winston-Salem, North Carolina. Disclosure: Weiss is a consultant/study investigator for Ferring.

How do you define nocturia? Is it the number of times someone awakens to pass urine, or is it the bother related to it?

Nocturia is just a symptom. It means that somebody has arisen from intended sleep time because of the desire to pass urine. That could be once or any number of times. In terms of how many times it takes for it to be bothersome enough to merit treatment, it's up to the patient. We know from epidemiological studies that moderate to severe bother really begins at 3 times. Most of the literature considers 2 times to be significant. There are patients for whom nocturia times 1 is a chief complaint.

What if you get up at night for some other reason, without the desire to urinate, and then you urinate? That is basically a convenience void with no desire and antecedent whatsoever. Technically, that would not be nocturia, but from a practical standpoint, it's always going to be captured as a nocturic episode when analyzing a voiding diary.

If a person is bothered by getting up at night to urinate and they see their primary care physician, what should do that physician do for the patient?

They should take a history and physical examination. Nocturia is a symptom that has so many different causes. Questions should cover drinking habitstypes of fluids, amount of caffeine, amount of alcohol. Patients should also be asked about general sleep architecturesome people nap a lot during the day or have trouble sleeping at night. These things should be elicited by the primary care physician.

Do they have hypertension? Could they have nondipping hypertension, which can cause natriuresis at night and nocturnal polyuria. Do they have peripheral edema? A routine physical exam would disclose, for example, peripheral edema, that could be due to third spacing. Even dependent edema, which is not related to venous insufficiency, can cause nocturnal polyuria. People who stand a lot and people who eat a lot of sodium may get some fluid accumulation in the lower extremities during the day and excrete that at night.

Assessing a patient for peripheral edema, heart failure, and venous disease is general medicine. If they have renal insufficiency and they have problems with excretion of free water at certain times during the night, do they take diuretics? Are they taking long- or short-term thiazides? These are all basic internal medicine principles.

The real question is, who's responsible for synthesizing all of that? Is it general medicine, or is it urology? It's not a turf battle; it's whoever is going to take an interest in it. I would purport that none of these require the skill set of a urologist. As urologists, we certainly pay attention to lower urinary tract symptoms (LUTS), but nocturia typically is not a normal lower urinary tract symptom.

From the urologist's point of view, what is the key question that they should be asking in order to separate nocturia from overactive bladder?

It's very simple; you go right to the definition of overactive bladder. The hallmark is urgency. If a patient has urgency, day or night, then they have overactive bladder symptoms. Now, it is true that if they have nocturnal urgency, there is some evidence that they might benefit from an antimuscarinic. Otherwise, if they have no urgency, the chances are that antimuscarinics, which are so overused for nocturia, will not work.

It's important to distinguish between daytime and nighttime LUTS. Many patients are referred for LUTS/BPH and you talk to them and they say, "I'm getting up at night." When you ask, how about during the day, they say, "No, during the day there's no problem." That's not really going to be OAB unless there's a strong urgency component.

It's incumbent upon all of us, including primary care providers, to examine the lower abdomen and make sure that we're not dealing with urinary retention. Admittedly, it's hard to palpate a bladder even when it's fairly full, but you wouldn't want to miss the ones that are grossly overdistended.

What is your working algorithm when evaluating a patient for nocturia?

As I mentioned earlier, a history and physical exam should be performed. You should obtain an accounting of medications, behavior, underlying medical conditions, and physical exam findings that may relate to nocturnal polyuria. A urinalysis should be done, as you don't want to miss hematuria and bladder cancer. PSA screening may or may not be something that you wish to undertake as part of the nocturia workup. I don't think it's central.

However, what is central and is unequivocal is a voiding diary, which includes a frequency voiding chart, accounting for time and amount of voiding. You should also include subjective sensations, such as an urge perception grade, or a degree of incontinence. Now, you're talking about a diary, which adds some subjective findings to the objective time and amount on the frequency volume chart.

The gold standard for a frequency volume chart is a 24 hourtechnically 3 full 24 hours, because there is considerable variability. Will a nocturnal only diary suffice? Yes, if you have excluded 24-hour polyuria. No matter how good you are, no matter how much you talk to a patient, even if they're on medications that cause polyuria, such as lithium, you won't know that a patient has global polyuria until they do the 24-hour collection. That doesn't necessarily have to be a frequency volume chart. A simple 24-hour collection to assess their 24-hour output would exclude global polyuria, which would be defined as 24-hour volume in excess of 40 milliliters per kilogram. Let's say in an average person, that would be around 3 liters. If they are putting out 3 liters, they're drinking at least 3700 milliliters, which is a lot. Why is that? Are they thirsty? Are they doing it because they think it's good for their kidneys? Are they dieting? Do they have a behavioral problem, or do they actually have a thirst problem?

What instructions do you give patients when you send them home to do the voiding diary?

I think it's reasonable to tell patients that they can drink in accordance with thirst, and no more. Thirst is rarely abnormal in any patient. If you tell patients to restrict themselves to a certain volume and they are able to stick to it, but that volume is insufficient to cover obligatory losses, they will fall behind and they can become hypotensive. Therefore, it's dangerous to tell patients to take in a fixed low amount of fluids without knowing whether they can actually concentrate urine.

I will ask patients, when you take your medications, do you take a pill with an 8-ounce glass of water because you need that much to get it down? Could you get that pill down with a gulp or sip of water? If your mucous membranes are dry, do you drink a glass of water, or do you just wet your mucous membranes? I'm trying to get patients to minimize intake. I explain to them that the dumbest kidney is smarter than the smartest doctor, and try to get them to realize that they don't necessarily have to "flush" their body to keep their kidneys going properly, that their kidneys will be just fine even with less intake.

A frequent complaint I hear from patients is that they are always thirsty at night, whether they breathe through their mouth or wake up and drink more during the night. How do you address this?

Look at the medications they're taking and see if any of them cause xerostomia. If they are taking one of these medications, can they be exchanged for ones that do not cause xerostomia? If it's just a case of waking up and being thirsty, I tell patients to just wash their mouth out and maybe take a little sip, rather than drink an entire glass. That will make a big difference.

What about excess urine output at night? How do you treat that?

That's nocturnal polyuria, which has 2 definitions. One is when, on a 24-hour voiding diary, more than 33% of urine volume is made at night. The other definition is a urine volume greater than 90 milliliters per hour; that's an absolute measurement that is not determined by 24-hour output. Once you find that they have nocturnal polyuria, you look for a cause. It could be behavioraldrinking too much fluids at night.

It could be sleep apnea. Sleep apnea causes nocturnal polyuria due to the fact that hypoxemia causes pulmonary artery vasoconstriction, which causes increased pressure in the right heart. The heart thinks there is too much stuff in the vessels and it excretes atrial natriuretic peptide, which is a very potent natriuretic and it turns off antidiuretic hormone and causes tremendous diuresis. That can be treated with continuous positive airway pressure.

It could also be peripheral edema. One of the first things I do in the office when someone says they're getting up at night to pass urine is lift up their trouser legs and see if they have pitting edema. I ask them: Do you have swelling in the legs? Do your shoes start to get tight at night? Some of them know they've got swelling. Some don't know it at all, and then you push in on their pre tibial area and you'll see the pit and they go, "Wow, that's amazing."

Peripheral edema can be due to heart failure. It can also be due to venous insufficiency, which is probably more common. It could be due to dependent edema, which you'll see in people who stand all day; for example, people who work in a department store or surgeons. Some people just love salt, and eating too much sodium will cause fluid retention in the legs, which returns as gravity no longer is the factor to the central circulation and results in nocturnal diuresis.

Of course, medications can also play a role. Taking a diuretic at night might cause nocturnal polyuria because you're inducing diuresis during the hours of sleep. Short-acting diuretics, such as furosemide or hydrochlorothiazide, are given first thing in the morning. If you are accumulating fluid in your legs, and you're waking up dry and take your diuretic first thing in the morning, you can't get any drier than you're going to be. Therefore, it's best to take a diuretic in midday, if it's a short acting drug, or in the morning, if it's a long acting drug such as chlorthalidone, which probably is a better drug for nocturia. Taking the wrong diuretic and the wrong antihypertensive at the wrong time will clearly exacerbate nocturia, as was found in a recent study published in the New England Journal of Medicine.2

It seems as though there is no "quick fix" for addressing the problem.

That's what is so frustrating about nocturia. It's 1 symptom, and it has easily 20 different underpinnings, which means that it's so easy to find things that result in nocturia. But because of the multifactorial nature, we only make little increments when we fix each factor. In particular, the older the patient, the more multifactorial it gets and the more difficult it is to treat. In the younger patients, there tends to be 1 or 2 big problems that can be solved with 1 or 2 major maneuvers. For example, in a young person with sleep apnea and nocturia, there's a very high probability that treatment will resolve it. You don't find too many patients like that though.

What about a patient who has nocturia and insomnia?

That's a little tricky. Sleeping pills work great for nocturia, but I never use them. Why? They're addictive. It's just not the class of drug that I feel comfortable using to treat insomnia.

Does the patient have abnormal sleep architecture? Maybe they just like to stay up at night and read or watch television or do something stimulating. That's not going to work. I tell them, "You're upside down with regard to your life." Of course, it's hard to fix someone who's a shift worker; that's about 2% of the population.

The first step is to diagnose it properly. On my diary, for the lower urinary tract symptom score, we have an urge perception grade for each void. If the urge perception grade for most of the nocturic voids is zero, that means that they were not awakened by the desire to pass urine. That's a sleep disturbance, so I would send them to someone who practices sleep medicine.

In terms of practical advice, a little exercise at night is helpful, doing whatever it takes to make them really tired at night; for example, reading a book and then drifting off to sleep. Now, if they have a prolonged sleep latency, and if they have easy awakening, that may be a little bit above the pay grade of a urologist, and that requires intervention by a sleep specialist. Typically, they're going to give anxiolytics and sleeping pills. Anybody can do that, but I don't like it as a treatment for anybody, frankly.

When does desmopressin come in?

That's a very good question. If you're a pharma company, desmopressin is basically treatment for anyone with nocturia. But the reality is, desmopressin is for someone who has nocturia in the absence of an underlying medical condition that's contributing to it. All these conditions that we talked aboutheart failure, sleep apnea, anything causing peripheral edema, certain medicationsall of those should be addressed first. We did a study that found that the minimum number of patients who have what we call the nocturnal polyuria syndrome, which is the ideal patient to receive desmopressin, is somewhere between 17% and 40%, depending upon whether you include hypertension in the numbers and what definition of nocturnal polyuria use.3

Why is the penetration of this drug so low? Are urologists afraid to use it in adults?

I think it's less fear than the obligation that one has to spend a lot of time on that patient. You need to know their baseline sodium. If they're over the age of 65, which so many of our patients are, it's recommended that you obtain a serum sodium within the first week of starting the medication or a dose increment and then follow-up sodium thereafter. I think there's a concern, particularly on the part of urologists, that they don't necessarily have the bandwidth or the office capability to follow patients so closely regarding their sodium.

Are there any new innovations in that regard that could lessen that issue?

There is research that is ongoing with new chemicals that are antidiuretics. The approved versions of desmopressin, which would be the orally dispersible tablet (ODT, Nocdurna) and the spray (Noctiva), are probably about the same in terms of their net total bioavailability and so the incidence of hyponatremia is actually quite low. If you select your patients carefully, then you don't have to worry nearly as much about hyponatremia.

Who are those patients that you don't have to worry about? First, patients who have normal baseline serum sodium and normal renal function. If you have normal renal function, you'll be hard pressed to accumulate desmopressin to the extent that it will cause hyponatremia. Sex is another factor. Women are more sensitive to desmopressin than men, which is why there is a gender differential in terms of dosing, at least for Nocdurna. There is no gender distinction in dosing with Noctiva. That's just the way that the studies were done. Women were found to be more sensitive to desmopressin melt than men. We know that females, at least in laboratory studies using a murine model, are about 2.7 times more sensitive to desmopressin than males. That's felt to be due to the fact that the V2 receptors seem to be encoded on the X chromosome, so that there's this phenomenon of X escape that women are more resistant to. Women can actually get away with a much lower dosage of 25 micrograms, compared with the recommended dosage for males, which is 50 micrograms.

Is there anything else you'd like to add?

For me right now, the most exciting area in nocturia research is the nexus between nocturia as a symptom, and cardiovascular disease. It may turn out that nocturia is actually a symptom of hypertension. We tend to think of hypertension as being the "silent killer," but it may be that many individuals have nocturia due to pressure-natriuresis, in turn caused by failure of blood pressure to dip normally at night. This nondipping hypertension is an intriguing phenomenon that we've known about for a long time but haven't really studied so well.

Also of interest to me is what we found in terms of responders to nocturia among those who do not have nocturnal polyuria: In these patients, their nocturia did not improve because their small bladders got bigger. As you well know from many years of practice, it's virtually impossible to give a medication that increases volume per void. We have great medications for urgency, but not for low voided volumes. So it turns out that patients who improve their nocturia who do not have nocturnal polyuria got better because their nocturnal urine volume went down despite the fact that it was normal to begin with. Those patients who responded clearly had mostly behavioral modification causing their normal nocturnal urine output to go down further, but also leads me to conclude that those patients might very well be treated with an antidiuretic, which currently is indicated for nocturnal polyuria. Accordingly, it may be that desmopressin could be indicated for small bladders. This is something that definitely deserves further consideration from a research standpoint.

References

1. Badlani GH. Data shift thinking on nocturias causes, treatment. Urology Times. November 20, 2018. Accessed August 12, 2020. https://www.urologytimes.com/view/data-shift-thinking-nocturias-causes-treatment

2. Victor RG, Lynch K, Li N, et al. A cluster-randomized trial of blood-pressure reduction in black barbershops. N Engl J Med. 2018;378(14):1291-1301. doi:10.1056/NEJMoa1717250

3. Emeruwa CJ, Epstein MR, Michelson KP, Monaghan TF,Weiss JP. Prevalence of the nocturnal polyuria syndrome in men. Neurourol Urodyn. 2020; 39(6):1732-1736. doi:https://doi.org/10.1002/nau.24403

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Nocturia: How to define it, and how to treat it - Urology Times

SAN DIEGO--(BUSINESS WIRE)--Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, today announced positive top-line results from CONTESSA, a Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC).

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with MBC. CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in 685 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progressionfree survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC. CONTESSA is being conducted at 180 investigational sites in 18 countries in North America, Europe and Asia.

CONTESSA met the primary endpoint of improved PFS as assessed by the IRC. Median PFS was 9.8 months for tesetaxel plus a reduced dose of capecitabine versus 6.9 months for the approved dose of capecitabine alone, an improvement of 2.9 months. The risk of disease progression or death was reduced by 28.4% [hazard ratio=0.716 (95% confidence interval: 0.573-0.895); p=0.003] for tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone.

Tesetaxel plus capecitabine was associated with a manageable side effect profile consistent with findings from previous clinical studies. Grade 3 treatment-emergent adverse events (TEAEs) that occurred in 5% of patients were: neutropenia (71.2% for tesetaxel plus capecitabine vs. 8.3% for capecitabine alone); diarrhea (13.4% for tesetaxel plus capecitabine vs. 8.9% for capecitabine alone); hand-foot syndrome (6.8% for tesetaxel plus capecitabine vs. 12.2% for capecitabine alone); febrile neutropenia (12.8% for tesetaxel plus capecitabine vs. 1.2% for capecitabine alone); fatigue (8.6% for tesetaxel plus capecitabine vs. 4.5% for capecitabine alone); hypokalemia (8.6% for tesetaxel plus capecitabine vs. 2.7% for capecitabine alone); leukopenia (10.1% for tesetaxel plus capecitabine vs. 0.9% for capecitabine alone); and anemia (8.0% for tesetaxel plus capecitabine vs. 2.1% for capecitabine alone).

Adverse events resulting in treatment discontinuation in 1% of patients were: neutropenia or febrile neutropenia (4.2% for tesetaxel plus capecitabine vs. 1.5% for capecitabine alone); neuropathy (3.6% for tesetaxel plus capecitabine vs. 0.3% for capecitabine alone); diarrhea (0.9% for tesetaxel plus capecitabine vs. 1.5% for capecitabine alone); and hand-foot syndrome (0.6% for tesetaxel plus capecitabine vs. 2.1% for capecitabine alone). Treatment discontinuation due to any adverse event occurred in 23.1% of patients treated with tesetaxel plus capecitabine versus 11.9% of patients treated with capecitabine alone.

Grade 2 alopecia (hair loss) occurred in 8.0% of patients treated with tesetaxel plus capecitabine versus 0.3% of patients treated with capecitabine alone. Grade 3 neuropathy occurred in 5.9% of patients treated with tesetaxel plus capecitabine versus 0.9% of patients treated with capecitabine alone.

While overall survival (OS) data are not mature, a recent interim analysis indicated the absence of an adverse effect on OS. A final analysis of OS is expected to occur in 2022.

Tesetaxel represents a potential important clinical advance for patients with metastatic breast cancer, said Joyce OShaughnessy, M.D., Celebrating Women Chair in Breast Cancer Research, Baylor University Medical Center, Texas Oncology and Chair, Breast Cancer Research, US Oncology, and Co-Principal Investigator of CONTESSA. There remains a significant unmet medical need for novel therapies that offer quality-of-life advantages for patients with metastatic breast cancer. This need is underscored by a recent update to the National Comprehensive Cancer Network guidelines recommending oral oncolytics that can reduce the frequency of clinic visits.

The clinically meaningful PFS improvement observed in CONTESSA, along with once-every-three-week oral dosing and low rates of clinically significant hair loss and neuropathy, could make tesetaxel an important new treatment option for patients with metastatic breast cancer, said Andrew Seidman, M.D., Attending Physician, Breast Medicine Service, Department of Medicine, Medical Director, Bobst International Center, Memorial Sloan Kettering Cancer Center and Professor of Medicine, Weill Cornell Medical College, and Co-Principal Investigator of CONTESSA.

We would like to thank all of the investigators, study team personnel, and especially the patients and their caregivers who made CONTESSA possible, said Kevin Tang, Chief Executive Officer of Odonate. We look forward to working closely with global regulatory authorities to make tesetaxel available to patients with metastatic breast cancer. We plan to submit a New Drug Application for tesetaxel to the FDA in mid-2021.

The Company plans to submit the results of CONTESSA for presentation at an upcoming medical meeting.

Conference Call Information

Odonate will host a conference call today, Monday, August 24, 2020, at 8:30 a.m. ET. To participate in the call, please dial (866) 300-4090 (domestic) or (636) 812-6660 (international) and use conference ID 2881009.

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in 685 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC, and disease control rate (DCR) as assessed by the IRC.

About Odonate Therapeutics, Inc.

Odonate Therapeutics, Inc. is a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. Odonates initial focus is on the development of tesetaxel, an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Odonates goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives. To learn more, please visit http://www.odonate.com.

Forward-looking Statements

This press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on managements expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: expectations regarding the outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with metastatic breast cancer; expectations regarding the enrollment, completion and outcome of our other clinical studies; expectations regarding the timing for our planned New Drug Application submission for tesetaxel and our ability to obtain regulatory approval of tesetaxel; the unpredictable relationship between preclinical study results and clinical study results; and other risks and uncertainties identified in our filings with the U. S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

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Odonate Therapeutics Announces Positive Top-line Results from CONTESSA, a Phase 3 Study of Tesetaxel in Patients with Metastatic Breast Cancer -...

On the nights when the mental sexual images of children were most overwhelming, Joseph Parker took cold showers and baths, hoping the shock of freezing water would push his intrusive thoughts away. Other times, he would fixate on a picture of the Sri Lankan Buddhist monk Henepola Gunaratana, so that the monk's "wrinkly face" might replace the disturbing imagery in his head.

Parker, who is using a pseudonym to protect his identity, had known he was attracted to children since he was 17, but he didn't start having overpowering sexual urges until he was 24. (He's now 26.) These urges were the worst when he was falling asleep. "As soon as I tried to release myself from wakefulness, my mind would sink into the pool of sexual energy, and I would feel this horrible sense of joy and happiness towards children, he said.

He read online about medications that could lower testosterone levels and, as a result, sex drivea process sometimes referred to as "chemical castration." When he asked a psychiatrist for these drugs, he was given Risperidone, an antipsychotic, instead. He took that for about a year, then added on Sertraline, an antidepressant, but only found these drugs mildly helpful. He turned to the internet to get what he had wanted in the first place.

From a Turkish division of the pharmaceutical company Bayers, he ordered cyproterone acetate, which lowers testosterone, along with the female hormone estradiol, and now takes the two medications together. The website that processes the sales is frequently shut down because of its illicit nature: "To my knowledge this is their third or fourth website change, at least, since I came upon them 14 months ago," he said.

Parker wishes it wasn't this hard for pedophiles to get sex-drive reducing medications. But for many pedophilesand especially pedophiles who have not committed crimesaccess to even talk therapy, let alone medication, can be difficult to come by, and the process is riddled with fears about being reported to legal authorities.

In the past several decades, researchers have arrived at new understandings about pedophilia, the sexual attraction to children. Pedophilia appears to be an in-born sexual preference, something a person does not choose and cannot change. A pedophile's attraction to children is consistentnot a phaseand they develop their attraction to children around the same time that other people develop sexual attractions.

While researchers' knowledge has been evolving, access to widespread, up-to-date healthcare hasn't kept up pace. Outside of the handful of researchers who provide therapy and medication to pedophiles, the barriers to finding an informed therapist or psychiatrist remain high. This has led to a hodgepodge of therapeutic approaches in the community, or people self-medicating, like Parker did. Many pedophiles are only directed towards treatment in the context of the criminal justice system, where in some states, chemical castration is used on sex offenders.

Yet importantly, researchers have established there's a distinction between pedophilia and child molestation, a difference between the attraction itself and the crime. Most people hear these words and think that they're synonyms. They're not, said James Cantor, a Canadian clinical psychologist and neuroscientist who studies pedophilia.

Only about half of child sex offenders are genuine pedophiles. The other half prefer adults sexually, and are abusing children because theyre available or easily manipulated. (Child porn offenders, on the other hand, are nearly always pedophiles because of the ready availability of adult porn alternatives.)

The goal of any modern, preventative treatment for pedophila should be to help people manage their sexual interests rather than try to change them, Cantor said. This can involve the voluntary use of hormone-reducing medication to control urges or therapy. Since pedophilia and sexual abuse are not synonymous, treatment for pedophilia is also not solely about preventing child sexual abuseits about helping people with their overall mental health and well-being too. Thats a concept that may be hard to accept. It involves recognizing that people who are sexually attracted to children deserve to live healthy and meaningful lives.

Online support groups for non-offending pedophiles have only recently entered the public eye. The most well-known group, the Virtuous Pedophiles, was formed in 2012 as a safe place for pedophiles to discuss their struggles and commitment to not offend. Parker belongs to the Virtuous Pedophiles and is known to the community as Double22. Another organization, the Association for Sexual Abuse Prevention (ASAP) was formed by some members of the Virtuous Pedophiles, and they are currently ramping up their goal to create a platform to connect pedophiles to mental health professionals.

"In my opinion, they should not be seen as second class patients.

In April of this year, the first randomized placebo-controlled study of a hormone-reducing drug for pedophilia took place in Sweden. Published in JAMA Psychiatry, it found that the drug reduced both high sexual desire and sexual attraction to children, and that the effects were noticeable within two weeks.

The study is the first to include people who self-identified as pedophiles and were seeking help of their own accord, not just people funneled from the criminal justice system. Whats even more remarkable about the study is that it included a placebo groupthe first pedophilia study to do so. In an editorial about the study, Peer Briken, a professor of sex research at the University Medical Centre Hamburg-Eppendorf in Germany, wrote that it marks a milestone in clinical sexual science and the field of forensic psychiatry.

I think one of the biggest problems is that people just don't understand this as a mental health issue, said Fred Berlin, an associate professor in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. Rightfully, people are concerned about protecting children. And so we just quickly stigmatize people who are attracted to children and often don't even see them as human beings with a problem who might be deserving of help.

"In my opinion, they should not be seen as second class patients.

In 2014, journalist Luke Malone wrote an article about young people, some of them minors, who were discovering that they were attracted to children, and how they were coping with it. It was adapted as an episode of This American Life, one of several high-profile media pieces about pedophiles that explored the complicated existence of being born attracted to childrenand how hard it is to get help.

When Adam, one of the young pedophiles in Malones story, admitted to a therapist what was wrong, she just became extremely cold and harsh, he told Malone. She even, a few times, almost got to the level of shouting. She ended up telling Adams mother.

There is a huge reason [pedophiles] would avoid therapists and doctorsthose people have an obligation to report them to police if they think children might be in danger in the future, said Ethan Edwards, one of the co-founders of the Virtuous Pedophiles, who uses a pseudonym.Especially if they are not specifically trained in the issue, and with the common belief that all pedophiles molest children sooner or later, it is very perilous for a pedophile to seek out a therapist.

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Christoffer Rahm, a psychiatrist, researcher at the Karolinska Institute, and the senior author on the JAMA study from April, once worked at a clinic linked to a Swedish national helpline focused on sexuality, PrevenTell. Rahm ended up meeting some pedophiles who called in; one was a bus driver who brought children to school. The bus driver was struggling with his impulses and fantasies, but had not sexually offended in any way. Rahm looked for research to help determine the best treatment for his patient and found a gap in the literature: There were no rigorous comparisons of different medications, or recommendations about who might do best with therapy. (As far as we know, female pedophiles are rarer, and the research on treatment for them even more sparse.)

Cantor feels it's more than just a gap when it comes to pedophilia. It is a black hole, he said. This is a topic that scientists in the fields of mental health are not just uninterested init is actively repugnant."

Thats what motivated Rahm to conduct his study. If there are people seeking help for this, the best thing would be to manage it in a preventative phase before the damage is done, he said. Of course, society needs to say that any kind of abuse against a child is not okay. But it is counterproductive if these people can't even seek help with a professional.

The medication Rahm studied is Degarelix, approved by the FDA in 2006 for treatment of advanced prostate cancer. This is the first time that it's been used off-label for pedophilia. Its an injection that starts working right away and lasts for about three months. It works by shutting down signals from the brain to the body to produce testosterone.

In qualitative interviews Rahms team did during the study, they found that some of their participants experienced positive effects. They described feeling an inner calm, Rahm said. They felt less pressure, that they had a better intimate life with their partners. Some described that the annoying thoughts around children disappeared so they can focus on other things. And many described that they had lost that enervating impulse to masturbate, and were able to see children as just human beings and not sexual symbols. A majority of the participants in the group that got the active drug said that they would want to continue taking it.

Many of the therapies that have been used for pedophiles have not been validated this way, but deployed through forensic psychology and the criminal justice system. Though Berlin has prescribed hormone-reducing medications to countless patients, he feels that the legal system usually doesnt collaborate with doctors and scientists who are studying the use of these drugs. As a physician, I think that's completely inappropriate, he said.

If someone goes to prison being sexually attracted to children, theres nothing about prison that can get rid of that attraction, or enhance a persons ability to resist temptation later on, Berlin said. It also leads to a mistrust of treatment, because of a history of involuntary use of chemical castration and aversion therapya therapy that associates negative cues with images of young children to dissuade future attraction.

The idea that we can solve this simply through punishment and incarceration is very naive, Berlin said.

Talk therapy should focus on managing a person's sexual interests, with an explicit acknowledgment that those interests will likely never change. In the past, therapy sometimes focused on searching for trauma, because of the belief that a history of abuse led someone to abuse. The truth is a bit more complicated. Having been sexually abused in your own childhood could be a factor in committing sexual abuse as an adult, but is not necessarily a factor in pedophilia.

This is what Ive heard over and over, Cantor said. They knew. They always knew it. All their past therapists were telling them to focus on trauma, what happened in their childhood. But their genuine experience of it was that they were born this way.

We need to move on to the next generation of research and quality development.

Cantor said that once that basic framework of therapy changes from changing ones sexuality to managing it, people adapt very quickly. It makes more sense to his patients, and theyre able to better commit. If a person has looked at child porn or committed sexual abuse in the past, a therapist would help them examine how and why their self-control broke down, and how to set up their life so that it doesnt happen againnot how to stop being attracted to children.

For some people, this process could be paired with sex-drive reducing drugs. Some people find they would rather live in that state than with those nagging sex drive that they can't express and can do anything to do anything about, Cantor said.

Yet even in those states that have issued mandates for sex offenders to receive hormone-reducing drugs as punishment, it can be incredibly difficult for non-offending pedophiles who want it to get medication. I get letters from people around the country all the time wanting access and they can't even get access to it, Berlin said.

Rahm doesnt advocate for medication to be used for every pedophile for lifehis study explores whether this specific drug could help. He said a person may only want and need it for a few months. It could help a person through a difficult time, or be combined with the start of a behavioral therapy practice. We need to move on to the next generation of research and quality development, Rahm said. We need to evaluate our treatments and to get evidence-based treatments out there so we know what we're doing.

The word castration has a dark history, and dark connotations. It's often been wielded involuntarily: In Germany the number of involuntary castrations of sex offenders increased as a result of the Nazi German Act, with at least 2,800 sex offenders were castrated between 1934 and 1944. In the United States, Black men accused of raping or sexually assaulting white women could find themselves subject to castration. For reasons like these, Rahm is torn about calling Degarelix chemical castration." While he thinks researchers and clinicians should accurately describe what the drug is doing and its side effects, he worries that referring to it as castration could scare people away, or disregard the consent and autonomy of patients who want it.

Rahm said that every person who participated in their study did so voluntarily, and was informed in detail about any possible side effects from taking Degarelix. They had the option to quit the study at any moment. Hes also currently running another placebo-controlled study on a non-pharmacological option: therapy geared specifically towards pedophiles that they can access anonymously, through the dark web.

The mere existence of Rahm's studies is important, outside of the details of the findings. Doing placebo-controlled studies on pedophilia was previously thought to be impossible, because of the ethical implications of not giving an active treatment to a group of people attracted to children.

In Brikens editorial, he wrote that because the medication they used was fast-acting, and they allowed anyone with pedophilia into the studynot just those who were high-risk for offendingit helped make the placebo group ethically possible. Briken concluded that Rahm's study was the most important contribution to the field of pharmacotherapy of pedophilic disorders since the original study of hormone reducing drugs in 1998, and offers a starting point for a more comprehensive approach to pedophila treatment.

In Germany, Prevention Project Dunkelfeld, which offers therapy and medication, has 10 locations throughout Germany, and a person can get help while remaining completely anonymous.

The demand for their work is high: After a BBC documentary on the Dunkelfeld Institute aired, the Guardian reported that Dunkelfelds hotline was overwhelmed with calls from British pedophiles. One British man was so desperate, he moved to Germany to be able to access a Dunkelfeld programme, the Guardian wrote. In an email exchange with the Guardian, the man, who wished to remain anonymous, wrote: 'So far, all I have ever received from the NHS is doors slammed in my face.'"

There's not as well-known a center for pedophiles in the U.S. to go to. Richard Kramer, the educational director at B4U-ACT, an online community for pedophiles, said he figured out he was attracted to pubescent boys in his 20s. (His attraction is to boys around the age of 12 or 13, which is technically called hebephilia.) I was very ashamed about it and thought that I was seriously defective as a human being, Kramer said, who is using a pseudonym. I really wasn't able to find any information about it. I didn't want to go to the library for fear that people would see what I'm looking up.

When he began reading information online, he said, everything he encountered was very negative. It said that I would be a monster, I would have hundreds of victims, and that my entire life would be centered around an elaborate plot to deceive parents and to manipulate children into abusing them, he said. So I thought, well, this is what they think about me. I have no interest in seeing them and seeing a therapist.

A big part of being successful in therapy is having the support of family and friends, something that pedophiles can lack. They often are going through difficult treatments alone, and are unable to talk about it to others. You cant tell co-workers, or ask a boss for time off for your appointments. You have two choices, said Michael Seto, a forensic psychologist and sexologist at the University of Toronto. You don't do it or you lie about it.

When Kramer was ready to look for a therapist again, he didnt really care what kind of approach they used, but was more concerned about whether they understood enough about pedophiles to not treat him like a criminal. His goals didn't involve a struggle to control his impulses, but to manage the shame and sense of isolation from others because he couldnt be honest.

We have to insist that people who have this orientation not act upon it, Berlin said. If we think about that, that can be quite a burden. Its not surprising that some of these folks might be in need of mental health assistance, because of the effect of experiencing these attractions on their sense of self-esteem and self-worth.

Happy, mentally healthy people do not molest children.

Some pedophiles are attracted to adults and children; some, only children. For those who are exclusively attracted to children and dedicated to non-offending, Kramer said, there needs to be a space for helping them grieve over not being able to have romantic and sexual relationships. How do they deal with loneliness? he said. There are other concerns, some almost mundane: How, for instance, do they deal with answering questions friends and co-workers ask about their personal lives? Hes had friends who asked him if he was gay, and he said he wasnt sure how to answer.

I'm not exactly gay, but I'm definitely not straight and I'm definitely not asexual, he said. How do you respond to that?

Gary Gibson founded the ASAP as one potential solution to this problem. Through an involvement with the Association for the Treatment of Sexual Abusers (ATSA), Gibson has been curating a list of therapists to whom he can refer pedophiles. The list is now around 400 names long. ASAP primarily focuses on non-offending pedophiles, but they will also help people who have offended and want to stop. People are just desperate out there, Gibson said.

He has worked with pedophiles who were so desperate for help that they underwent physical castrations. One man traveled to Mexico to have the operation done; when he returned, he tried to find a doctor to supervise his recovery and medications. I could not find a doctor who would take him on, Gibson said. They didn't want him in the office. I did find a therapist to work with him, and I kind of lost contact with him. Im worried about what happened to him.

Until recently ASAP has been handled almost entirely by Gibson, but ASAP is currently undergoing a significant expansion. It has increased its office and volunteer staff, is making a new, online database of mental healthcare providers, and creating a 24/7 helpline. Gibson said his dream is to get a multimillion dollar grant to create a mentor program for teenagers, aged 13 to 17, who are learning that theyre pedophiles. Ive applied three times, he said. Maybe the third time's the charm, because Ive been denied twice.

The goal is to help every non-offending person attracted to children find therapy if they want or need it, said Robert Hillman, a lifelong virtuous (non-offending) pedophile, and the new president of ASAP. Hillman said that the mantra is: All pedophiles are born non-offending, and the aim is to help keep it that way. Happy, mentally healthy people do not molest children," he said.

People do the most desperate things when they feel the most desperate, Cantor said. A lot of what these groups and therapy provide is helping people lead a life that is worth protecting. When they have a life worth protecting, thats when people get the energy and the willpower to control themselves, because they dont want to risk the life that they have.

What Hillman and Gibson want is the opportunity for any person attracted to children to chart their own path, and figure out what works best for them. That may include an experimentation with medication, and it may not. ASAP doesnt control their therapiststhey all operate independently, using different methods of treatment. They're not always successful. One guy has committed suicide that I know of, Gibson said said. But I think that we have probably saved a few lives and saved many children from being abused.

These support groups and therapy networks are providing a lifeline, but alone, they don't guarantee a consistency in treatment, nor fill the gaps in the scientific literature when it comes to which treatments might be best for a certain person. There might be certain hormone-reducing medications that are less risky or work better than others; certain pedophiles that fare better without drugs; certain therapeutic practices that are more helpful than others. Those answers aren't clear-cut.

As with all medications, some people have good experiences and others do not. Pedophiles can identify as ego-dystonic or ego-syntonic. Ego-syntonic people consider pedophilia as part of their identity, and can be okay with fantasizing and masturbating about children (though not with porn), while ego-dystonic people are not. It may be that treatment should be different with those who have different attitudes towards their attraction, even if members of both groups have the same commitment to not offend.

After about five weeks, Parker said that he felt better from the medication he had ordered online. It was night and day," he said. "I can't tell you what a weight was lifted off of me, or a pressure from under me that was relieved. Whenever I think about it I just lay back in my chair and breathe a contented sigh, knowing that I won't suffer like that again. Both physical urges in my body and intrusive imagery in my mind have disappeared."

He doesnt think that medication should be thought of only as a stop-gap to a person committing sexual abuse. Offending was never a danger for me in the first place, he said. He doesnt take the medication to stop himself from molesting a child, but as a way to improve his quality of life.

When Max Weber, who helps run a peer-support website for pedophiles in Germany, realized his attraction to young girls in his early 20s, he said, he was terrified. My picture of pedophilia at the time was the same wrong impression most parts of society have: that pedophiles were bound to offend, he said.

Weber got treatment at Dunkelfeld, and said he views medication like a pair of eyeglasses. You can put [them] on to help yourself focus on things that you want to change about your life.

To Weber, pedophilia was like being surrounded by deep water; he had to struggle to stand on his toes to avoid drowning. I needed all my strength to cope with it and dont drown in my own fears and self-hate, he said. As a result sexual impulses felt very powerful since, when you are standing on your toes, even the slightest push could throw you over.

He took medication for about nine months. During that time when his sexual feelings were repressed, he regained a foothold on his life, he said, and found that even without medication he is able to be around children without issue. I now know that I am in charge, and no one can make me offend other than myself, he said.

Two years ago, David, a 22 -year-old recent college graduate from New York and a volunteer for a peer-support group including pedophiles, desperately wanted to take hormone-altering medication. I hated myself for having feelings about children, and I just wanted to be like everyone else," he said. "I was also going online and finding articles about how to raise libido, and doing the opposite of all of the advice I found. But I couldnt find a therapist I felt safe coming out to.

Since then, he said that support groups like Virtuous Pedophiles have helped him realize that being attracted to children is not something he chose, and hes not tempted towards any illegal behaviors. In the end, there was no need for me to go through such a treatment with dangerous side effects," he said.

Though he never ended up trying medication, David thinks his experience with peer support reveals something important. Medications can help reduce physical symptoms, he said, but the restthe support, the isolation, the shameall needs to be addressed outside of just taking a pill.

I struggled with serious depression, anxiety, and self-hatred as a teenager starting to understand that I was a pedophile, David said. Becoming less isolated, having people to help when I was hurting, and being able to help others in the same way is what brought me back from that.

Hillman was a patient of Berlins about 25 years ago. I was on the brink of madness from the desires and from the shame and self-hatred and loathing, he said. "It was crushing me and I was not going to survive it. He took hormone-reducing medication with Berlin's help, and said that combined with therapy, it saved his life. Since I was at that time and have always been non-offending, my anti-androgen therapy was not mandatory in any way and thus I started and stopped it several times, because of the affordability issues, Hillman said. But I can attest that the medication did reduce my thoughts and therefore some of my distress.

Then he found the Virtuous Pedophiles group about one year ago, and the support hes culled from the others there has given him a new gusto for life, without medication. Now I am dedicated to living. And I am dedicated to making sure no one else has to waste their life just to be virtuous, he said.

Hillman said that these narratives reveal how all pedophiles are different. Some will benefit from meds and some will not, he said. Some are against medication, some are not.

Rahm hopes to continue studying treatment options for pedophilia, in a rigorous way. In his view of a forthcoming modern pedophile treatment, each person would get an individual assessment and be offered an evidence-based treatment. It would work with helping a pedophile address both their personal feelings and concerns, and also their risk of offending.

In my vision, some people need therapy, some need medication, some need both, and some won't have any effect on any of these. They need something else, Rahm said. This is nothing novel or groundbreaking, he added. I would just like to apply modern psychiatric thinking to this group.

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Paedophilia Is a Mental Health Issue. It's Still Not Treated as One - VICE

From left, Declan, Cian and Rowan pose on the front porch of their Norwood home this week. Declan and Cian, identical twin brothers, and fraternal sister Rowan, were conceived through in vitro fertilization and born as micro preemies. Christopher Lenney/Watertown Daily Times

NORWOOD Expert fertility statistics and probability outcomes would never have accounted for the DeShane triplets.

Born on different days and in different years two splitting an embryo and all surviving natural births three Norwood babies have beaten the odds.

At 22 weeks, 6 days, Cian J. DeShane was born Dec. 28, 2019, at the University of Vermont Medical Centers Neonatal Intensive Care Unit. With tubing in, he spanned 11 inches and weighed 1 pound, 0.9 ounces, about the weight of a loaf of bread.

After being fully-dilated and having contractions for 5 days, Cians umbilical cord cut, Kaylie E. (Mousaw) DeShane gave birth to Cians identical twin brother Declan B. and their sister Rowan M. on Jan. 2, 2020. Declan weighed 1 pound, 7.6 ounces, and Rowan came in at 1 pound, 1 ounce.

All six eyelids were fused shut at birth, but outside their Norwood home during a brief visit this week, the DeShane triplets looked out at the world, at bicyclists passing on Main Street, with bright excitement.

Nurses at the University of Vermont Medical Center NICU awarded the DeShane triplets each a Grammy for achieving weight milestones. Christopher Lenney/Watertown Daily Times

If they had been carried to full-term, Cian, Declan and Rowan would be about 4 months old. Now nearly 8 months old, the trio is meeting all adjusted milestones expected of 4-month-olds.

But the wide-eyed, growing and curious babies were once barely bigger than an adults palm. At 15 days old, Rowans entire hand was the size of her dads index fingernail. Cian and Rowan developed an intestinal disease; Cian fought pneumonia; and all three struggled with respiratory issues, particularly in their first days and weeks of life.

During the uncertain four months the triplets spent in the NICU, Kaylie said, dozens of family, friends and strangers prayed for the miracle babies, the uterine warriors, as one UVMC specialist put it.

As the weeks rolled into months at the NICU, Kaylie and her husband Brandon J. DeShane initially stayed at the Burlington Ronald McDonald House in shifts until the COVID-19 pandemic shut down the country mid-March and Ronald McDonald families were kicked out.

The hospital, Kaylie said, covered hotel rates during the remainder of the triplets NICU stay, which totaled about $1 million in medical costs for each member of the trio, the early births qualifying the DeShanes for Medicaid.

Kaylie E. DeShane holds her son Cian for the first time Jan. 16, at the University of Vermont Medical Center NICU. Cian was born at 22 weeks, 6 days, on Dec. 28, 2019. His identical twin brother Declan and fraternal sister Rowan were born Jan. 2, 2020. Provided photo

With two children at home in the north country, 11-year-old Naveah and 6-year-old Holden, Kaylie and Brandon took turns making the 120-mile trip between Norwood and Burlington, and the babies continued vanquishing every life-threatening emergency.

The theory of their persistence, their fight, Kaylie said, became centered on the bumblebee, and a phrase popularized by the introduction to the 2007 animated Bee Movie.

According to all known laws of aviation, there is no way a bee should be able to fly, the screenplay reads. Its wings are too small to get its fat little body off the ground. The bee, of course, flies anyway because bees dont care what humans think is impossible.

Though a misconception that bees or other insects break fundamental laws of physics through flight, the idea of the impossibility originated from French entomologist and engineer Antoine Magnan. In the 1930s, he famously compared bumblebee flight to the aeronautics of powered flight to doing the unthinkable.

That concept became the lifeblood of the DeShane triplets, who didnt know they shouldnt be able to fly.

And they didnt care, Kaylie said, adding that the seeming attitude of Cian, Declan and Rowan inspired rallying hope spanning two states, and reaching an online community of thousands of mothers of micro preemies. If they believe they can make it, then we should believe them, too.

Brandon J. DeShane holds Cian, left, and Rowan, on the front porch of their Norwood home this week. Cian was born at 22 weeks, 6 days on Dec. 28, 2019. Rowan, along with Cians identical twin Declan, was born almost six days later on Jan. 2, 2020. Christopher Lenney/Watertown Daily Times

What are the odds?

Kaylie, originally from Potsdam, is a senior chemical dependency counselor for St. Lawrence County. She and Brandon, a Norwood native and current stay-at-home dad, married in 2015. Naveah is Kaylies stepdaughter, and the couple officially adopted Holden in 2017. When Kaylie and Brandon decided to begin the process of having biological children about four years ago, they worked with Northeastern Reproductive Medicine, a fertility clinic in Colchester, Vt., to address infertility issues and Kaylies Polycystic Ovary Syndrome, or PCOS.

PCOS, according to the Mayo Clinic, is a hormonal disorder causing excess production of male hormone levels, infrequent or prolonged menstruation and increased potential for the ovaries to develop fluid pockets and fail to regularly release eggs. The Centers for Disease Control and Prevention reports PCOS as one of the most common causes of womens infertility, affecting as many as 5 million women of reproductive age in the United States.

Through in vitro fertilization, the manual combination of an extracted egg and a sperm sample in a laboratory setting, two of Kaylies fertilized eggs were transferred to her uterus last year. Months and sometimes years before a transfer can be conducted, fertility medications are prescribed to stimulate egg production and adjust hormone levels. Once implanted in the wall of the uterus, one of Kaylies embryos split, leading to identical twins Cian and Declan.

Kaylie E. DeShane holds her son Declan for the first time Jan. 13, at the University of Vermont Medical Center NICU. Provided photo

To avoid a multiple pregnancy and its risks, including miscarriage, premature delivery and low birthweight, most fertility clinics prefer to transfer a single embryo to a womans uterus. Given Kaylies infertility, she said, Northeastern agreed to transfer two.

Figures of chance for twin and triplet births vary by reporting agency and method of conception, and depend on a familys fertility history and differing data collection across clinics.

But generally, the chance of carrying identical twins to term is rare for any conception method. The chance of one embryo splitting and a second successfully implanting through IVF, resulting in identical twins and one fraternal sibling, is rarer still.

Based on years of published research before it, a 2016 Columbia University study of 27 IVF providers and 10 patients indicates twins born to mothers through IVF are 12 times more likely than single babies to be born prematurely, 16 times more likely to have low birthweights and five times more likely to be born with respiratory complications.

Due April 26, 2020, the DeShane triplets fulfilled all three of those projections.

Neonatologist Deirdre OReilly, UVMC director of the Neonatal Medical and Developmental Follow-up Clinic, will see Cian, Declan and Rowan for at least the next two years. The DeShanes continue to make regular visits to their local physician, as well as UVMC specialists, including a pediatric pulmonologist for lung health and an ophthalmologist for vision.

Kaylie E. DeShane displays a preemie diaper, one too big for her triplets when they where born weighing about 1 pound each. Christopher Lenney/Watertown Daily Times

Last month, Dr. OReilly told UVMC Childrens Hospital she had never, in her 13 years of practice, seen a baby born as early as Cian survive.

Full-term babies are carried for 39 weeks, and the World Health Organization sets the pre-term threshold at 37 weeks, with those born between 28 and 32 weeks categorized as very pre-term. Babies born alive after less than 28 weeks are considered extremely pre-term. The United States, according to the most recent WHO data, ranks sixth among countries with the greatest number of pre-term births each year, 517,400 in 2017.

For micro preemies birthed at 22 to 23 weeks, extended infant survivability is low, and some hospitals may choose not to attempt intense medical interventions or treat life-threatening conditions, depending on whether policies are in place.

The American Academy of Pediatrics and the American Congress of Obstetricians and Gynecologists both recommend families develop their own plans with clinicians, should decisions need to be made about treating extremely pre-term babies.

The DeShanes told their delivery room team they wanted anything and everything to be done for the triplets.

The New England Journal of Medicine in 2015 published data about more than 4,000 premature babies born between 2006 and 2011, all before 27 weeks of gestation. The overall rate of survival for those born at 22 weeks who did not receive active treatment was 5.1 percent. The survival rate for 22-weekers who received active treatment defined in the study as any potentially lifesaving intervention administered after birth was calculated to be 23.1 percent.

Over the last decade, support for such interventions at 22 weeks has grown, among clinicians and families with children who survived birth between 22 and 25 weeks.

Nurses at the University of Vermont Medical Center NICU logged every note and decorated photos for each of the DeShane triplets over the four months they spent in the NICU. Christopher Lenney/Watertown Daily Times

Twenty Two Matters

With each update and each minor victory, the DeShanes support network expanded the DeShane and Mousaw families led prayer and cheerleading efforts in the north country, along with mothers from the nonprofit TwentyTwo Foundation. The foundation serves as a sister organization to the online group TwentyTwo Matters, nearly 5,000 advocates and mothers celebrating micro preemies and their milestones.

But in the hours and days after she went into labor, and despite such support, Kaylie said, she felt like giving up.

Kaylie and Brandon had traveled to Burlington for a scheduled anatomy scan Dec. 27, and were staying at a hotel in Plattsburgh when her water broke.

Kaylies cervix had already failed once, meaning her cervix the tissue at the neck of the womb that opens during childbirth was weakening and opening too early. At 16 weeks, the risk of miscarriage or pre-term birth was high, and Kaylie could either miscarry intentionally or undergo a cervical cerclage procedure to close her cervix. Cervical cerclage stitches the cervix closed, but the procedure itself, coupled with Kaylies already high-risk pregnancy, was risky for both mother and babies. Kaylie could have hemorrhaged and a failed cerclage could have prompted an even earlier birth.

I wasnt going to voluntarily kill my babies by doing nothing, she said. So they stitched me up.

By the time fluid drenched the hotel room floor 6 weeks later, Kaylie was preparing for the worst. She said she even texted her family members, asking them not to call and assuming Cian, Declan and Rowan, with names picked out, wouldnt survive. Twenty-two weeks, she thought, was just too early.

At 15 days old, Rowan holds her father Brandon J. DeShanes hand for the first time Jan. 17, at the University of Vermont Medical Center NICU. Rowan was born Jan. 2, with her brother Declan, about five days after the first triplet, Cian, was born. Provided photo

Once at Champlain Valley Physicians Hospital in Plattsburgh that night, the DeShanes were told a transfer to UVMC was not immediately available, that it would be faster for the couple to drive themselves. So Brandon drove Kaylie to the western shore of Lake Champlain, where they ferried across to Vermont. The soon-to-be mother of triplets arrived barefoot in the snow.

The morning of Cians birth, Kaylie had severe pain and bleeding because the eldest triplet had torn through her cervical stitches.

Then it all happened so fast, she said.

Adorned in yellow gowns, four NICU nursing teams were at the ready, one dedicated to each baby and one to Kaylie.

Cian was successfully intubated, initially receiving oxygen 24/7 with the ventilator breathing for him. Then at 23 weeks, 4 days, and in a new year, Kaylie gave birth to Declan and Rowan.

Rowan, who had a severe brain bleed that didnt worsen and eventually resolved itself, later developed necrotizing enterocolitis, or NEC. The CDC lists NEC as a leading cause of infant mortality in the United States, and medical professionals dont fully understand the intestinal disease, though it is clear it primarily affects premature infants and presents with a swollen belly or bloody stool.

Rowan stabilized, but Cians NEC prognosis was less positive, and the DeShanes were asked to write an end-of-life plan for him. Kaylie refused, and Cian overcame.

That would mean wed be giving up, that we believed he wasnt going to make it, she said. And we couldnt believe that.

Cian also developed pneumonia and NEC more than once, most recently recovering in March, and hell eventually have surgery to remove a hernia the first surgery for any of the DeShane babies.

Bumblebee emblems gradually started to appear in the NICU, bees were pinned to nurses badges as teams diligently and quietly cared for the triplets. One word uttered too loud, one step too forceful, and the fragile beings would have suffered.

Five words floated in the air of the unit: Dont give up on them.

Kaylie E. DeShane holds Declan this week in Norwood. Declan was born Jan. 2, 2020, at 23 weeks, 4 days. Christopher Lenney/Watertown Daily Times

Eleven days after his birthday, Declan was approved to be held on Jan. 13. Cian and Rowan followed, on Jan. 16 and 17.

Naveah and Holden spent their February school break at the Ronald McDonald House with their parents, visiting their siblings for the week.

What hell they had to go through, Kaylie said of her two older children, who spent months with only one parent at a time, always prepared for a reality that their baby brothers and sister might not have come home.

Declan, born the largest and having the fewest major issues, celebrated his homecoming April 17, beating his due date by nine days. Rowan left the NICU April 30, and Cian arrived in Norwood May 4. Home aides have assisted with daily monitoring, and the babies now only receive extra oxygen while sleeping at night to foster growth, no longer needing ventilators to survive.

Declan is an active trouble maker, Cian an old man, Kaylie said, because of his noises and groans. Rowan curls into a ball, like a hedgehog, when she doesnt want to be touched.

For the DeShanes, 2019-20 has been a roller coaster year, with a pregnancy announcement, a rare triplet birth, a global pandemic and more than $3 million in medical bills.

You take it one day at a time, Kaylie said. You look back later and you have no idea how you did it.

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Norwood triplets, born on different days in different years, beat the odds - NNY360

When it comes to experimental cholesterol drugs, all eyes this year are on inclisiran, the $9.7 billion RNAi drug Novartis hopes will replace and vastly outsell Regeneron and Amgens PCSK9 inhibitors.

Yet Regeneron has been quietly preparing for approval of its own new cholesterol drug, a niche antibody meant to treat a narrow slice of patients not covered by Praluent, the biotechs original PCSK9 inhibitor. Last year, the company reported topline, pivotal data. Last week, a BLA submission for the drug, known as evinacumab, was accepted andgivenpriority review by the FDA.

And today, in theNew England Journal of Medicine,Regeneron published the full data from the pivotal study supporting the application, showcasing some of the first significant cholesterol reductions in patients with a rare genetic disorder calledhomozygous familial hypercholesterolemia and pointing toward a therapy that could yet have broader applications.

As far as homozygous patients, this is a great, great advance, Evan Stein, a University of Chicago cardiologist who has studied the condition for over 40 years and was not involved in the paper, toldEndpoints News, for a very difficult and high-risk group of patients who need additional therapies.

In the Phase III trial, 65 patients with the condition, often shorthanded as HoFH, were randomized to receive either placebo or evinacumab. Praluent and its Amgen-developed rival Repatha treat high cholesterol by increasing the amount of LDL receptors on the liver, where they sap up the LDL cholesterol soaking in the blood. But because patients with HoFH have mutations that leave them with no functioning LDL receptors to begin with, their cholesterol levels dont come back to normal.

PCSK9 inhibitors, statins and other drugs have helped these patients blunting what could once be a fatal disease but most have continued to have elevated cholesterol and some continue to need to filter their blood with aphersis every two weeks, Stein said.

Yet in the Regeneron study, patients who received evinacumab saw their LDL levels fall by 47% over 24 week, while those in the placebo rose by 1.9%. In an accompanying NEJMeditorial, Wageningen University Sander Kersten noted that may mean patients wont need apheresis. The results of this trial are great news for patients with homozygous familial hypercholesterolemia and may reduce the need for invasive treatment, he said.

Unlike PCSK9 inhibitors or inclisiran (which stops production of PCSK9), evinacumab targets a hormone called angiopoietin-like 3, or ANGPTL3. Although its still unclear why ANGPTL3 affects cholesterol, scientists studying mice and later humans in the early 2000s learned that it did, and researchers have since been trying to figure out how to turn that insight into medical interventions.

In 2013, Ionis and Genmab developed Kynamro, an antisense oligo-nucleotide that targeted a similar protein for HoFH, but the risk of liver damage was too high for it to be commonly used.

It was a terrible drug, Stein said, noting it was never approved outside the US.

By contrast, side effects were virtually non-existent for evinacumab, Stein said. Adverse events were more common in the placebo group, where 81% had an AE, than in the treatment, where 66% did. There were two non-fatal serious adverse events in the treatment group: a suicide attempt and urosepsis, a kind of sepsis cause by a urinary infection. Five patients on the treatment arm saw an influenza-like illness but no patients on placebo did.

Still, there was room for further research. Stein said that the group most unaddressed by current therapies was kids, yet the Regeneron study excluded patients beneath the age of 12 and only included 2 patients between ages 12 and 18.

Thats where the greatest need for treatment is, he said. It would be great, if this could be extended down to children.

For Regeneron, the immediate goal-line is the FDA decision, which is due by February 11. Still, Kersten argued the study also raises a larger question: whether evinacumab will have applications in patients beyond HoFH which affects just 1 in 160,000 to 1 in 300,000 people.

That would mean both greater sales of Regeneron and a drug for patients who, despite statins and PCSK9 inhibitors, cant get their LDL under control. Those patients could include people withheterozygous familial hypercholesterolemia i.e. people with one functioning and one fault LDL receptor who often, but not always, respond to existing treatments.

Stein, though, argued that the drug would have to be easier to administer for that to happen. It currently has to be infused by IV once per month. HoFH patients will accept that, but others more addressed by current therapies wont.

Long-term, Stein is looking at new methods that could bring a one-and-done fix. He pointed to Verve and their recent animal study using CRIPSR base editing to fix a different cardiovascular condition.

The holy grail may be doing gene replacing or knocking out a gene or modifying it, he said. But were a long way from that.

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Regeneron flashes 'great advance' in the NEJM for that other cholesterol drug sitting at the FDA - Endpoints News

Asthma is a chronic respiratory disease that affects more than 25 million people in the US. Asthma generally causes swelling of your airways, making it harder to breathe and causing symptoms like coughing.

However, there are many different types of asthma, like allergic or occupational asthma, that can have a variety of symptoms. Finding out which type of asthma you have can help you figure out the best way to treat it.

Here is what you need to know about the different types of asthma and how each is treated.

Allergic asthma is the most common type of asthma, and affects about 60% of asthmatics in the US. If you have allergic asthma, your symptoms, like coughing or struggling to breathe, are triggered when you breathe in allergens.

Some of the most common allergens are:

When you are exposed to these triggers, your immune system interprets them as harmful invaders and releases antibodies that cause your airway to swell up and become narrower, making it harder for you to breathe.

Your doctor can determine what allergen triggers your symptoms by doing blood or skin tests. If you have allergic asthma, you will need to avoid allergy triggers and you may need to take a prescription medicationlike Montelukast (Singulair), which helps decrease the inflammatory response that tightens airways.

Your doctor may also suggest allergy shots, which slowly introduce small amounts of an allergen into your body so that you gradually build up a tolerance. You may also need an albuterol rescue inhaler, which can quickly open your airway during an asthma attack.

Exercise-induced asthma is a more mild form of asthma in which your symptoms only arise after exercising.

"Symptoms do not start during exercise when the airways are dilated, but rather 10-15 minutes after when adrenaline levels, which help dilate the airways, come down," says Arjan Flora, MD, a professor of pulmonology at the University of Cincinnati.

You are most likely to have asthma symptoms like chest tightness or wheezing after exercising in cold, dry air, since it can make your airways swell and constrict.

According to Flora, the best ways to prevent exercise-induced asthma are:

And be sure to always carry an inhaler when you know you are going to be working out.

If you have cough-variant asthma, your main asthma symptom is a persistent dry cough. It's typical not to have other asthma symptoms like shortness of breath or wheezing.

"Treatment for cough variant asthma is largely the same as for regular asthma, using the same medications," says Neil Schachter, MD, a professor of pulmonary medicine at the Icahn School of Medicine at Mount Sinai.

This includes daily corticosteroid inhalers like budesonide (Rhinocort) and flucytosine (Flovent) to reduce swelling in your airways and an albuterol rescue inhaler for flare-ups.

"However, the most important feature of treatment is making sure that the diagnosis is correct," Schachter says. This is because other conditions like hay fever or acid reflux can also cause a chronic cough. Discussing your symptoms with your doctor can help rule out other possible conditions.

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease that prevents your airways from expanding properly, leaving some air trapped inside your lungs when you exhale. COPD symptoms usually begin in middle age and the main symptoms are shortness of breath, coughing, and excess phlegm.

If you have asthma-COPD overlap (ACO), you may exhibit all the symptoms of COPD along with typical asthma symptoms like wheezing and chest pain. ACO can cause attacks that are especially severe and can lead to hospitalization.

The most common cause of COPD is exposure to cigarette smoke, though some people may develop the condition after long-term exposure to irritating gases or fumes like car exhaust. By the time your symptoms appear, "the lungs are frequently damaged beyond repair," says Schachter. This means that while you can get your symptoms under control, you generally can't stop the disease from progressing.

Though ACO can be more serious than asthma, "in many ways the treatment is the same," Schachter says. This can include taking a long-acting airway opener like Singulair, a corticosteroid inhaler like Pulmicort, and an albuterol rescue inhaler for attacks. You may also need to add on additional medication to prevent mucus build-up.

Occupational asthma occurs when you develop asthma symptoms after being exposed to irritating substances like chemical fumes, animal waste, or smoke in your workplace. There have been over 250 different agents identified that can trigger occupational asthma.

Occupational asthma develops when you regularly inhale substances that can irritate your lungs, which leads to swelling of your airways and difficulty breathing. This irritation can be caused by an allergen, like animal dander or plant substances, or a universally irritating substance, like chlorine gas, chemicals in detergents, or metals like platinum.

According to Flora, some of the most high-risk jobs for exposure to allergens are:

The most high-risk jobs that may expose you to general lung irritants are:

The best way to prevent and treat occupational asthma is for companies to provide protective gear and train workers to safely handle irritants. Under the Occupational Safety and Health Administration (OSHA) guidelines, your employer is legally required to offer you these protections. You can also meet with your doctor to come up with an individual safety plan and get standard asthma medications.

Nocturnal asthma occurs when your asthma symptoms get significantly worse at night. Nocturnal asthma is common and can happen along with any type of asthma, including allergic or non-allergic.

The symptoms of nocturnal asthma are the same as regular, daytime asthma, but you may also experience symptoms like daytime sleepiness and frequent waking in the night. This is because frequent bouts of nocturnal asthma can interfere with your natural sleep schedule and lower the quality of your sleep.

Experts aren't sure why asthma symptoms can become worse at night, but one factor may be your hormones. In particular, levels of a hormone called histamine can spike while you are asleep , which can lead to swelling of your airways and awaken you from sleep.

"Additional complicating factors include dust mites and pet dander which can be in bed sheets, pillows, and mattresses," says Flora. So if you have allergic asthma, you may need to wash your bedding more often and keep pets out of the bedroom to fight off nighttime symptoms.

Non-allergic asthma occurs when your asthma symptoms are triggered by factors unrelated to allergens like pollen and dust. Non-allergic asthma generally starts later in life most people over 40 who develop asthma for the first time will have non-allergic triggers.

Experts are not certain why non-allergic asthma develops, but having repeated infections in your airway like bronchitis can increase your risk of non-allergic asthma, Flora says.

There are many possible triggers for non-allergic asthma, including:

The symptoms of non-allergic asthma are essentially the same as allergic asthma, including chest tightness, coughing, and difficulty breathing. After having an allergist rule out the possibility of an allergy, your doctor may work with you to identify your triggers. The treatment is also similar to allergic asthma, using long-term preventative medications and fast-relief inhalers.

If you find yourself having asthma symptoms, it's important to meet with a doctor as soon as possible to help get your symptoms under control.

Monitoring your own symptoms can also help out with diagnosis, Flora says. "Keeping a diary of onset of symptomatic episodes with potential triggers/exposures, time of day, location (ie work, outdoors), and the presence of other medical conditions can help you and your doctor discover what type of asthma you have and how you may prevent symptoms from occurring."

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CARLSBAD, Calif., Aug. 20, 2020 /PRNewswire/ --Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (Qualigen or the Company) announced today that the United States Patent and Trademark Office has issued patent No. 10,744,257 entitled "Devices and Methods for On-Line Whole Blood Treatment" regarding the Company's Selective Target Antigen Removal System (STARS) technology.

STARS is a DNA/RNA-based treatment device candidate for the removal of viral and tumor-produced compounds from a patient's blood. The STARS technology utilizes a filtration cartridge designed for use in a standard dialysis machine, and contains aptamer-coated microparticles that bind to specific agents in circulating blood for targeted removal.

"This patent strengthens our intellectual property portfolio and increases our number of issued patents to 26, or 45 including jointly held patents. Our strategy is to continue to protect our proprietary technologies in the U.S. and globally," said Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "Although STARS is in the early stages of development, our in vitro studies have demonstrated encouraging proof-of-concept results and we look forward to advancing this program as a target-and-removal therapy for a broad range of diseases."

The STARS development program utilizes technology and expertise from the Company's FastPack point-of-care diagnostic system, which has been in use worldwide for nearly 20 years for the detection of cancer and other diseases. The Company plans to develop STARS for cancer applications to remove inflammatory factors and inhibitory checkpoints from blood, thus reducing pain and helping the body's immune system fight the disease, as well as for infectious diseases to remove viruses and other foreign agents.

About Qualigen Therapeutics, Inc.Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational aptamer of ALAN, AS1411, is also being studied for use in treating viral-based infectious diseases, including COVID-19. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes' proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world. The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2. Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com/.

Forward-Looking StatementsThis news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's intellectual property protection intentions and potential future development, testing and launch of STARS and other product candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development of the Company's drugs or therapeutic devices will be successful; that clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices will receive required regulatory approvals or that they will be commercially successful; that patents will issue on the Company's in-licensed patent applications; that such patents, if any, and the Company's current owned and in-licensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products; that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products generally, particularly in view of COVID-19-related deferral of patients' physician-office visits and FastPack reimbursement pricing challenges; that adoption and placement of FastPack PRO System instruments (which are the only FastPackinstruments on which the Company's SARS-CoV-2 IgGtest kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Company's SARS-CoV-2 IgG test. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available atwww.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

SOURCE Qualigen Therapeutics, Inc.

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LOS ANGELES For Adam Winney, a 26-year old with Type 1 diabetes, grocery shopping during the early days of a pandemic was an infuriating task. Everything was sold out, except for the one type of food he couldnt eat.

The only things left were carbs, carbs, carbs, the Van Nuys resident said. Ive never been more furious than back in March.

Winneys disease has deprived his body of insulin, a hormone thats needed to turn the sugar in carbohydrates into energy. Without it, his blood sugar can spike to dangerous levels, eventually leading to serious health problems like cardiovascular disease, nerve damage and kidney failure.

But the insulin pens he relies on to keep his body in balance cost him upwards of $1,000 a month, since his health insurance doesnt cover the medication.

After the coronavirus outbreak cost him his job as a receptionist at a hair salon, that expense was beyond his reach. He went six weeks without the long-acting insulin he usually takes every day.

COVID-19 presents a unique set of challenges to the roughly 34 million Americans like Winney who are living with diabetes.

The Centers for Disease Control and Prevention says people with Type 1 diabetes are probably more susceptible to a severe case of COVID-19. Those with Type 2 diabetes the more common form that begins when people lose their sensitivity to insulin are definitely at increased risk of severe COVID-19, according to the CDC.

For instance, a study of more than 7,300 COVID-19 patients in China found that those with Type 2 diabetes needed more medical care and were nearly 50% more likely to die than patients without diabetes.

The risk of death was especially high for people who had trouble controlling their blood sugar, researchers reported. Another study of more than 1,200 COVID-19 patients in the U.S. found that the mortality rate for those with diabetes or high blood sugar was 29%, compared with 6% for those without diabetes.

The extent to which you control your diabetes is a risk factor, said Dr. Daniel Drucker, a senior scientist at the Lunenfeld-Tanenbaum Research Institute at the University of Toronto. Theres a lot we can do about that, by making sure that your diabetes is optimally controlled.

Insulin is essential for keeping blood sugar in check, but the pricey medicine is harder to get if a job disappears, along with the health insurance that came with it.

The cost of insulin varies from patient to patient. It depends on the type of insulin they need some take effect within 15 minutes; others last more than a day _ as well as the dose. Some insurance plans pick up more of the tab than others.

The financial strain brought on by the pandemic has forced Royce Jonathan Miller of Yuba City to consider rationing the insulin he takes for Type 1 diabetes. He has kept his job as an optician at Walmart, but since his father-in-law lost his job at a maintenance company that closed operations due to the pandemic, Miller has become the sole provider for the four people in his household.

Miller has an insulin pump, which uses a tube to continuously deliver a small amount of insulin directly to the pancreas. He is supposed to change out the pieces that connect to his body every three days. Lately, hes been wondering if thats absolutely necessary.

Im starting to think, I can stretch that up for two cycles, every six days, and hopefully it doesnt get infected, Miller said. But I do realize that if I am to make myself sick and wind up in the hospital, that will be a bigger burden.

A nationwide survey of 5,000 people with diabetes conducted for the American Diabetes Assn. found that one in four have rationed supplies to cut the cost of their diabetes care since the start of the pandemic.

Now is not the time to let up on helping these individuals manage their disease, because it may in fact be helpful in preventing them from getting severe COVID-19, Drucker said.

People with Type 2 diabetes may face even greater hardship in affording their insulin, said Dr. Francisco Prieto, a family health physician in Sacramento.

Not everyone who has Type 2 has to take insulin, Prieto said. Those who do are typically folks who either have the most severe cases of diabetes or have failed all the previous oral and injectable treatments. That means they may need to take even more insulin on a daily basis than Type 1 patients, he said.

Since 2019, 11 states have set limits on the amount insurance companies can set as co-payments for insulin. Each of those states has enacted price caps ranging from $25 to $100 per month since the coronavirus outbreak took off in March.

California may soon join the list. In February, Assemblyman Adrin Nazarian, D-North Hollywood, introduced a bill that would cap insulin copays at $50 for a 30-day supply, or $100 per month. It passed in June by a 64-4-11 vote, but the Senate Health Committee has not scheduled a hearing that would allow the bill to move forward.

Winney said a price cap would give him some peace of mind. These days he relies on free samples provided by one of his doctors, but that generosity may not last.

I see that as an incentive to finally change insurance, he said.

Ensuring an affordable supply of insulin would help people with diabetes manage their disease better, said Brandi DaVeiga, a stay-at-home mom in Lakewood with Type 1 diabetes. She has good coverage now through her husbands health insurance plan, but when she was between plans three years ago, she began skipping insulin doses to make her supply last longer. On several occasions, her blood sugar levels rose dangerously high, and she ended up in the emergency room.

Its really stressful, she said of managing diabetes during a pandemic. And that doesnt help your blood sugar.

The fact that people with diabetes are rationing their insulin when they need it most points to larger problems with health care access in this country, Drucker said.

COVID-19 is reminding us of the importance of doing everything we can in our vulnerable, at-risk populations, he said. Lets do everything we can to optimize their health because that may, in turn, reduce their risk of having a bad outcome with this virus.

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Amid COVID-19 pandemic, people with diabetes struggle to get insulin - Press of Atlantic City