Archive for the ‘Hormone Physician’ Category

If you find yourself managing busy family life, social life, and career, its common to feel tired and achy sometimes. But do ever wonder if youre achiness and fatigue maybe something more? Are they symptoms of a stressful life, or could they be tied to an underlying condition like an autoimmune disease?

Dr.Redd, a Chiropractic Physician with a Masters in Human Nutrition from RedRiver Health and Wellness is addressing why many people with low thyroid and auto-immunityissues still have their symptoms after being on medication and seeing many specialists. Symptoms of autoimmune disease may be severe in some people and mild in others, but there is a way to get help as one lifelong athlete found.

Nicole, an avid fitness fan and now a recovered patient of RedRiver Health, explained how she feels after seeing Dr.Redd. RedRiver works to make patient satisfaction a top priority and every chiropractic physician and administrative team member works hard to ensure that each patient receives attention and individualized care.

Suffering from chronic symptoms that affect your ability to live your life can be frustrating. Many people visit multiple doctors and specialists and still cant find good answers about what is causing symptoms. People often brush symptoms off as just being the result of a busy and active lifestyle, or the result of stress from kids, work, and life in general. But when they start to get in the way of your ability to live your life its time to figure out exactly whats causing these symptomsa proper diagnosis is critical to find the right treatment.

RedRiver start with extensive testing that delves deeper than most lab panels, then add testing for everything from food sensitivity or intolerance to parasites, hormone imbalances, and adrenal function. They work to understand exactly what is happening inside your body so we can effectively eliminate the issues you are experiencing today while avoiding future flare-ups or a return of symptoms.

RedRiver Health and Wellness has offices in Springville, St. George, Logan, and South Jordan.

For more information, visitRedRiver Health or call (866) 36-RIVER for a free consultation or download a free guide on their website.

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Lifelong athlete recovers from a hidden health condition that plagued her for years - ABC 4

USADA announced today that Abu Azaitar, of Rabat, Morocco, has accepted a seven-month sanction for a violation of the UFCAnti-Doping Policy.

Azaitar, 34, tested positive for tamoxifen and/or tamoxifen metabolite 3-hydroxy-4-methoxy-tamoxifen as the result of urine samples collected on August 25, 2020, September 4, 2020, September 9, 2020 and September 17, 2020. Tamoxifen is a Specified Substance in the class of Hormone and Metabolic Modulators and is prohibited at all times under the UFC Anti-Doping Policy and UFC Prohibited List.

After being notified of his positive test, Azaitar provided evidence (including medical records), that he was prescribed tamoxifen by a physician to treat symptoms. Tamoxifen is a selective estrogen receptor modulator used therapeutically to treat certain types of cancer in females and also prescribed off-label for males with various other conditions. Although the substance was taken at the direction of a physician, Azaitar lacked a valid Therapeutic Use Exemption (TUE) and his subsequent application for a retroactive TUE was denied due to lack of sufficient medical justification. Under the applicable rules, Azaitar was eligible for a reduction to the period of ineligibility based on the specific circumstances of his case and for his Full and Complete Cooperation.

Azaitars seven-month period of ineligibility began on August 25, 2020, the date his first positive sample was collected.

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Statement on Abu Azaitar | UFC - The Official Website of the Ultimate Fighting Championship

Hi, everyone. I'm Dr Kenny Lin. I am a family physician at Georgetown University Medical Center, and I blog at Common Sense Family Doctor.

Kenneth W. Lin, MD, MPH

2020 was a very tough year for primary care clinicians, even when we weren't regularly treating patients with COVID-19. Last spring, the number of preventive services provided at community health centers well-child visits, Pap smears, A1c tests for patients with diabetes, and screening mammograms fell by one half to two thirds compared with the previous year and had not returned to their usual levels by the end of the summer. Although in some cases telehealth can replace in-person visits, a retrospective analysis posted online ahead of print by the American Academy of Family Physicians' Robert Graham Center suggested that two thirds of typical primary care visits require at least one in-person service, such as an immunization or blood draw.

Pandemic-related declines in well-child visits and adult physical examinations not only had negative financial effects on primary care practices, but also raised fears that delayed cancer diagnoses would lead to thousands of preventable deaths in children (O'Neill A and colleagues; Ding Y and colleagues) and in adults (Sharpless NE; Maringe C and colleagues). As a result, even though daily death and hospitalization rates from COVID-19 are exceeding the peaks from last spring and summer, hospitals and medical practices have been strongly encouraging patients not to defer routine care.

Medical offices are generally safer for patients now than they were during the first few months of the pandemic, when infectious disease protocols were not well established, and in many places surgical masks and other PPE were in short supply. But we do patients a disservice by pretending that primary care can or should return to "business as usual." Preventive services, by definition, are offered to persons without symptoms of the diseases we are trying to prevent, and false-positive test results can lead to harmful diagnostic cascades. For example, one study found that nearly 1 in 5 seniors who underwent a Medicare annual wellness visit in 2014 received at least one nonrecommended test (eg, electrocardiography, urinalysis, thyroid-stimulating hormone), and many of these "low value" tests led to further tests that required additional in-person encounters.

Even for recommended screenings, overall benefits may only exceed harms by a small margin (Ropeik D; Carr T). Compared with management of acute symptoms or chronic conditions, cancer screening does not help most patients; the best evidence indicates that one needs to screen approximately 1000 patients to avoid one death from breast, colorectal, or prostate cancer.

Last summer, current and former members of the Canadian Task Force on Preventive Health Care argued that the increased infection risk associated with an in-person healthcare visit during the pandemic should cause us to consider extending recommended screening intervals and permanently abandon the evidence-free tradition of performing annual or periodic physical examinations on adults without a specific indication. I wholeheartedly agree!

The development of effective coronavirus vaccines has raised hopes that disruptions to primary care will only persist until enough people have been immunized to make it safe to fill up our waiting rooms again. That prediction may turn out to be true, but it would be a shame to miss this once-in-a-lifetime opportunity to reassess the value of routine medical services.

Sorenson and colleagues have suggested that health professional organizations develop "do not restart" lists for their members on pandemic-deferred services that are wasteful or likely to do more harm than good; the American Board of Internal Medicine's Choosing Wisely campaign is a good place to begin. I propose that family medicine's "do not restart" list include not only outdated tests but office processes, too, including the aforementioned waiting room. As is routine in many restaurants and hair salons, patients could wait outside or in their vehicles and receive a text message when it's time for them to be seen, limiting exposure to other potentially ill persons and allowing the practice to use the no-longer-needed waiting space for another purpose.

Kenny Lin, MD, MPH, teaches family medicine, preventive medicine, and health policy at Georgetown University School of Medicine. He is deputy editor of the journalAmerican Family Physician.

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Ditch the Waiting Room (and Other Post-COVID Ideas) - Medscape

Every year, the month of January is celebrated as Thyroid Awareness Month to raise awareness regarding the various health problems related to the thyroid gland. The thyroid is a small, butterfly-shaped gland located at the base of the neck and plays a major role in the metabolism, growth, and development of the human body. It also helps in regulating several body functions by releasing hormones into the bloodstream.

If the thyroid gland doesnt function properly, you may develop several diseases, including hyperthyroidism, hypothyroidism, Hashimotos disease, Graves disease, goiter, and thyroid cancer.

Thyroid awareness month seeks to raise awareness regarding these diseases, their causes, symptoms, treatment, and prevention.

Symptoms of Hypothyroidism

Symptoms of Hyperthyroidism

Stand in front of a mirror, tilt back your head, and take a sip of water

Observe the area below Adams apple for signs of bulging

Repeat the process a few times and note down the observations

If you see excessive bulging, nodules, or enlarged glands, contact your physician immediately

The only way to be sure, however, is to perform a blood test that measures your thyroid hormone levels. Usually, a physician would recommend a TSH (Thyroid Stimulating Hormone) test. Depending on the amount of hormone present in your system, the physician can then zero in on the type of thyroid disorder that you may be suffering from and prescribe appropriate treatment accordingly.

It is much more difficult to diagnose thyroid-related disorders in senior citizens because many of the symptoms associated with a malfunctioning thyroid gland overlap with the symptoms of aging. Symptoms like loss of memory, weight gain, and constipation are a few examples.

January is thyroid awareness month: All you need to know about thyroid disorders

Read more| Tax benefits for investing in national pension system: Here's all you need to know

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January is thyroid awareness month: All you need to know about thyroid disorders - India Today

Since February is American Heart Health month, what better time to raise awareness of heart disease and stroke, especially among women. Did you know that heart disease is the No. 1 cause of death for women in the United States? More women than men die of heart disease, but many women are unaware of the danger theyre in.

Heart disease is a term that covers several types of diseases of the heart, blood, arteries, and veins. Having heart disease can often result in heart failure, heart attack, stroke, or peripheral artery disease. The risks for developing heart disease range from age, gender, family history, diet, blood pressure, level of cholesterol, diabetes, obesity, and stress.

It doesnt take much to improve your heart health for both men and women. In fact, heart disease is about 80 percent preventable when you make the right choices. Ready to make over your heart? Lets get started.

There are a couple of things that always need to be stressed. First, avoid cigarette smoking and secondhand smoke. The reasons are clear: Smoking contributes to the buildup of fatty substances in the arteries, increases blood pressure, and lowers good (HDL) cholesterol. Plus, a double whammy for the heart, smokers also tend to have more difficulty exercising.

You dont have to quit alone. Smoking cessation classes are offered at Bingham Memorial Hospital. For more information, please call (208) 785-3820.

Physical activity is so powerful. If you can do nothing else, move every day. People who are active are better at controlling their weight, keeping blood pressure low, and managing cholesterol levels.

You dont need to huff and puff to reap the benefits a daily 30-minute brisk walk (or three 10-minute walks) is a good start.

A healthy diet is essential to a healthy heart. Start by avoiding processed foods and loading up on fruits and vegetables. Having a colorful plate leads to heart-healthy choices. Favor vegetables over fruit preferably.

One of the keys to a healthier ticker is managing stress.

Stressful situations can start a number of chain reactions. Your body releases adrenaline, a hormone that temporarily causes your breathing and heart rate to speed up, and if youre under constant stress, this can keep happening on and off.

While researchers are still trying to understand the exact link, they do know that stress raises blood pressure levels. And for some people, it might invite unhealthy coping mechanisms, like smoking or alcohol.

So what can you do to chill out? Its easy. Youll feel better with just 20 minutes of daily laughter, meditation, yoga, or even just deep breathing.

When we dont get enough sleep, we see increases in the stress hormone cortisol and blood pressure levels. Constantly elevated cortisol and blood pressure damages the lining of the blood vessels of the heart. Try to aim for seven to eight hours of shuteye each night.

6. See Your Doctor Once a Year

High blood pressure and elevated blood sugar and cholesterol levels raise your risk of heart disease. But you wont know whether your numbers are high without seeing your family medicine provider or a cardiologist.

To promote good heart health, be sure to take care of yourself and visit your primary care physician at least once a year. Have a discussion with your primary care doctor to see where you are. If your levels are out of range, your doctor may prescribe medications that can help control these risk factors.

About Bingham Healthcare Cardiology

Bingham Healthcares cardiologists are certified to diagnose and treat disorders of the circulatory system and the cardiovascular system the heart, arteries and veins. Using the latest and state-of-the art technology, they provide initial diagnostic services, including basic cardiology evaluations, consultations, stress tests, heart pathology, and arrhythmia detection.

With complete cardiology coverage throughout Eastern Idaho, the following cardiologists are always welcoming new patients.

Call to schedule a consultation in Blackfoot: (208) 785-3897.

Call to schedule a consultation in Idaho Falls: (208) 524-9404.

Call to schedule a consultation in Pocatello: (208) 239-8027.

Dont wait until its too late to treat cardiovascular disease. Youll be glad you did.

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Give your heart a makeover - Post Register

From getting first-hand information at our fingertips to interacting with the world around us, it is beyond question how technology affects every area of our lives. Although it offers humanity the platform to access information that is beyond reach, its increased usage can greatly affect our mental health. The associated risks to technology happen when its use is not controlled. Every day, technological advancements keep increasing at the speed of light as breakthroughs in almost every field are a result of it. But, understanding its double-edged impact can greatly influence how we use it. Starting with its negative effects, lets take a look at the various impacts of tech on our mental health.

Adverse Effects of Technology

Sleep Problems

According to Dr. Saju Matthew a board-certified family medicine physician, excessive exposure to bright lights from your smartphone, computer, and tablet can block the secretion of the hormone that helps you sleep. So it is advisable that you set a bedtime and you put away your phone and other smart devices that can interfere with your sleep as this time approaches. Sleep is very important to our health because it removes toxins that build up while you are awake from your brain, it also allows your body to repair itself. Poor sleep can affect your mood by causing anxiety disorders which weakens your bodys ability to fight diseases.

Are you always eager to know whats up online past your bedtime? You may be suffering from problematic internet use. If you find it difficult to keep up with work demands or your relationships due to your mobile device. This may be a sign that it has taken over your life, and you should see a mental health physician.

Emotional Problems

Although social media connects you to the world. Its prolonged use can disconnect you from family and friends in real life. It can make you feel inadequate and dissatisfied with your life when you compare your achievements to others. These negative emotions can affect your mood in a bad way by making you feel stressed and anxious. These symptoms will further increase your addiction to social media and the cycle continues if you dont seek medical help on time. If you discover that your use of social media is making you angry, aggressive, or distracted, you need to control your use of it by reducing time spent online. Also, in a situation where you suffer from cyberbullying or you find yourself doing crazy things to get likes and shares, you need to re-access your use of social media.

Digital Eye Strain

Do you experience eye discomfort when viewing digital screens for extended periods? You may be having digital eye strain. Digital eye strain goes along with symptoms such as dry eyes, itchy eyes, blurry vision, headache, difficulty in concentrating when reading, and increased sensitivity to light. Other factors are bad lighting, screen glare, and bad viewing distance. A poor vision can affect your daily tasks and even your social life which in turn will affect your mental health. To relieve your eyes from strain, reduce your screen time, and adjust the lighting around you.

Musculoskeletal Problems

According to a study, using smartphones for extended hours can cause problems in the nerves, joints, tendons around the shoulders and arm resulting in musculoskeletal disorders. Leaning forward when using a smartphone can stress your neck, spine, and shoulders. You can also experience repetitive stress injuries around the wrist and arms. Repetitive stress injury occurs when you stress the same muscles over time through bad posture. Symptoms include swelling, stiffness, weakness, numbness, and pain ranging from mild to severe. With this disorder, carrying out your daily activities can become a problem. It can lead to depression if you dont get social support on time.

If you are feeling pain from the use of technology, maintaining a proper posture while working and taking frequent breaks to stretch will reduce these issues but if symptoms persist, see a physician.

Children and Technology

Adults are not the only ones that suffer from the negative use of technology, technology affects the mental health of children and teenagers too because they spend a lot of time watching television, playing video games, and using tech toys. Too much screen time can cause sleep problems and behavioral problems in children. Low academic performance and creativity have been associated with children who overuse technology. To control the negative effect of technology on children and teens, use the American Academy of Pediatrics screen time recommendation as a guide:

-Reduce the amount of time spent watching educational programs for children between 18 24 months.

-For children between ages 2-5 years, reduce non-educational programs to 1 hour per weekday and 3 hours during weekends.

-Incorporate healthy screen habits for children between ages 6 and older.

-Use the screen to build creativity and togetherness with family and friends.

-Help your child learn other activities like music, arts, and sports that do not involve a screen.

Positive Effects of Technology

With over 800 apps dedicated to mental health alone, technology has made mental therapy accessible via some mental health apps. Some of these applications provide valuable insights into how you can feel much better whenever you are feeling depressed. They come either free or affordable, making it easier for many people to get.

Many people living in areas far away from their primary care providers can access online treatment in a timely fashion. While using smartphone apps cannot be compared to doctor-to-patient physical consultation, they provide vital information to mental health professionals.

Imagine a world without technology. Navigating physical interactions and mental wellbeing will have been impossible especially in a time like this when various lock-down restrictions are put in place to reduce the spread of the coronavirus. The pandemic increased online engagements across various social media platforms. And most importantly, it has offered avenues for many websites to provide social support.

Optimizing the Use of Technology to Boost Mental Health?

You need no soothsayer to predict that technology will continue to change the world. Rather than exploit it to the point where it becomes harmful to your health, you can explore new ways to maximize its power to improve your health. This can be achieved by using wearable devices, telehealth, and health apps while you enjoy the bond that comes with spending time with real-life friends.

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The Effects of Technology on Mental Health - Thrive Global

Suzy Cohen, Columnist Published 5:02 a.m. ET Feb. 1, 2021

Having an autoimmune condition, or a thyroid condition can make you more susceptible to COVID-19 complications.(Photo: Eraxion / Getty Images)

Having an autoimmune condition, or a thyroid condition can make you more susceptible to COVID-19 complications. Think of autoimmune conditions in the same manner you would other immunosuppressive disorders (i.e. cancer, organ transplantation, history of radiation treatment or chemotherapy).

As it pertains to Hashimotos thyroiditis, Graves disease or hypothyroidism you need to be extra vigilant while youre out in public because your immunity is compromised.

The right dose of thyroid medication, and the right kind are critical because you may not be getting enough active thyroid hormone (T3) to your immune system which resides primarily in the intestines. While your body struggles to make do with whatever hormone is available in your body, you may experience symptoms such as poor concentration, chronic fatigue, hair loss, apathy, sensations of being cold, depression and/or anxiety.

If you have autoimmune thyroid disease, or hypothyroidism, your immune system may not be able to protect you from foreign antigens or invaders. These include new cancer cells, microorganisms, toxins, and even simplistic signals that your body should see and dont due to low thyroid. If youre low in thyroid, your protection against invaders is hindered.

When you have poor T4 to T3 conversion, I call it being thyroid sick and the solution is thoroughly discussed in my best-selling book called, Thyroid Healthy, available on Amazon. The situation makes you hypothyroid and you could have many, if not all, the symptoms that go with it, especially suppressed immune function, and more frequent colds, fever blisters, rashes and UTIs.

Some doctors prescribe both medications to a patient, meaning both T4 drugs and T3, but getting the right dose is tough on doctors (and patients) because its like trying to hit a moving target.

Generally speaking, because the cytokines will be imbalanced in a person with autoimmunity, the recovery time from an infection could be lengthened. There are vitamins that can keep your immune system in tip-top shape during the season. And, Im passionate about herbal medicine. One reason that herbs work well and have strong anti-viral, anti-bacterial and anti-parasitic effect is because they have a wide spectrum of medicinally active constituents.

This means they have a wide range of beneficial impacts in the body aside from their kill action.

I want each of you to be very thoughtful while reading this and remember to never suddenly go off your medication because of something you read. Going off a medication can be problematic for two main reasons:

If youd like to receive my newest ebook on immunity, download it now at https://www.store.suzycohen.com/strengthen-immune.

More: Ask the Pharmacist: How hawthorn lowers blood pressure

And: Ask the Pharmacist: Solutions for gastrointestinal upset

Also: Ask the Pharmacist: Five effective tips to lose weight

Suzy Cohen is a registered pharmacist. The information presented here is not intended to treat, cure or diagnose any condition. Visit SuzyCohen.com.

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Ask the Pharmacist: Autoimmune disorders and infection risk - Marco News

During a Targeted Oncology Case-Based Peer Perspective Roundtable, Sara M. Tolaney, MD, MPH, associate director, Susan F. Smith Center for Womens Cancers, director, Clinical Trials, Breast Oncology, director, Breast Immunotherapy Clinical Research, senior physician, Dana-Farber Cancer Institute, and associate professor of Medicine, Harvard Medical School, discussed therapies available for the treatment of a 42-year0old women with HER2-positive breast cancer.

Targeted OncologyTM: What are your thoughts on the results of the poll?

TOLANEY: It looks like most people voted for TCHP [docetaxel, carboplatin, trastuzumab (Herceptin), pertuzumab (Perjeta)] and then 1 voted for AC [doxorubicin, cyclophosphamide] + THP [paclitaxel, trastuzumab, pertuzumab]. I think these are both reasonable choices. I think knowing that there is lymph node involvement is prompting people to use pertuzumab-based therapy. So, the question [is:] do you want to give anthracycline-based therapy versus nonanthracycline-based treatment? Given some newer data, I [tend] to now use nonanthracycline- based therapy for the vast majority of my patients since I have been using TCHP.

How would you assess this patients risk, and what factors should you keep in mind when assessing risk?

This was a fairly sizable tumor with nodal involvement [that was] high grade, HER2 positive, ER negative...These are all high-risk features. And so, certainly prior to the advent of trastuzumab [Herceptin], this patient would have a high risk of recurrence. The issue about ER will often come up as to whether or not it is truly a prognostic indicator in HER2-positive disease, where so much of the benefit from therapy is really driven by HER2.

If you look at long-term outcomes from HER2-positive patients in the adjuvant setting, and you were to compare the ER-positive versus ER-negative patients, you can see that their long-term outcomes are not that dissimilar. ER-positive, HER2-positive patients tend to do slightly better. They have a different time frame to recurrence, though. Youll see that ER-positive, HER2- positive cancers tend to have recurrences a bit later than the ER-negative, HER2-positive cancers. But in the long run, when you follow them out 8 to 10 years, the difference is quite small between their long-term outcomes. But we do know that in a preoperative setting that the ER-positive, HER2-positive patients do have a lower likelihood of achieving pCR [pathologic complete response] to preoperative therapy, even though...their long-term outcomes are not that dissimilar.

Would you recommend neoadjuvant systemic therapy for such patients?

I find it hard to know what to do for that patient because if they ended up having, [for example], 1.2-cm HER2-positive cancer that was node negative, you take them straight to surgery and they could get away with just TH [paclitaxel, trastuzumab]. We know that their long-term outcomes will be good with TH [in the] stage I setting, with 98% recurrence-free interval out to now almost 7 years.1

But the problem that I have is I dont know their nodal status, and I dont really know how much cancer they have. So, Im always a little worried that Im either under- or over- treating them, depending on what you end up finding out later. Because of that fear, I have tended to take most of my patients [with masses] under 2 cm to surgery first, so that I know what [they are dealing with, in order to make] that final treatment decision.

It does put you at risk potentially for finding [a patient with] stage II disease, which is problematic, because I would have wanted to give them preoperative therapy. Then I could potentially give them postoperative T-DM1 [ado-trastuzumab emtansine; Kadcyla] if they had residual disease. But on the flip side, I worry that if the patient who I think has stage I disease ends up having stage II disease and has nodal involvement, then Ive undertreated them. And so, I find it a little tricky to know how much to give them if [their tumor is] small. I think its a balance, because you dont want to overtreat, you dont want to undertreat, particularly when you are at this high 1s1.8, 1.9 cm; that is where I struggle a bit.

There are a lot of studies ongoing that I think could...make this a little more comfortable. There is a preoperative trial through the [National Cancer Institute], the CompassHER2- pCR study [NCT04266249], which is looking at preoperative THP. And if someone achieves pCR, they go on to [receive] HP [trastuzumab, pertuzumab]. In my mind, if that study pans out and shows that we could potentially get away with THP in stage 2 patients, for example, then I would not feel so bad about giving my [patient with a] 1.8-cm mass THP up front because it was probably an effective amount of therapy; maybe they didnt need the pertuzumab. We know from the APHINITY study [NCT01358877], for example, [that] there is no benefit from pertuzumab in our node- negative patients.

But at least I didnt give them a ton of chemotherapy that they didnt need; TCHP, in my mind, is difficult; with carboplatin, pertuzumab, they have a chance of diarrhea, so thats not easy. Whereas weekly THP is easy for most patients; its not so bad. And so, we need to find a middle ground and were just not quite there yet. It sort of seems [as though] were picking between extremes of TH and then TCHP. And I think thats part of whats driving some of this problem.

For [a patient such as] this, it would be clear to do preoperative treatment.

Would you consider using anthracyclines in a patient such as this in the preoperative setting?

[You may] remember BCIRG 006 [NCT00021255], which compared TCH [docetaxel, carboplatin, trastuzumab] with ACT [AC followed by docetaxel] or AC-TH, showed that the anthracycline and nonanthracycline arms had fairly similar disease-free survival [DFS]. This was prior to pertuzumab becoming a standard, and it was also at a time when the study wasnt powered to technically compare AC-TH to TCH, but we knew the DFS looked similar regardless of nodal status.2

But a more modern era trial is the TRAIN-2 trial [NCT01996267]. In this case, it was a different because they used paclitaxel with carboplatin and HP, not the traditional docetaxel and carboplatin. The comparator arm is also a little different than I typically would use because its FEC [5-fluorouracil, epirubicin, and cyclo- phosphamide] with HP followed by the taxane with HP.

What we showed was that the pCR was the same with either armanthracycline versus nonanthracycline. Now we have follow-up to almost 50 months,3 and the event-free survival is also the same. So, [there was] no statistically significant difference in event-free or overall survival.

There is also a subgroup analysis that showed that even if you looked at the high-risk, node-positive patients in this study, there was still no difference in event-free survival between the 2 arms. And [analysis showed] less cardiac toxicity, numerically less leukemia, and less febrile neutropenia with a nonanthracycline-based therapy.

Since these data have emerged, it has made me feel much more comfortable using nonanthracycline therapy because were seeing that, even with long-term follow-up in a modern era of pertuzumab-based therapy, there is no difference in long-term outcomes between anthracycline and nonanthracycline therapy. In my mind, there isnt much rationale to consider anthracycline- based treatment for HER2-positive patients.

Do you agree with this approach?

If you look at the preoperative trials, generally pCR rates are in the 60% range from TCHP. So, it is a highly effective preoperative therapy. We do know that those patients who achieve pCR have better long-term outcomes than those who have residual disease. And so, trying to maximize chances to get pCR makes sense for patients, and generally that is my approach, as well.

Obviously, there is interest in trying to develop less-toxic approaches. I fully admit that were seeing more toxicity with anthracycline-based therapy. I think we all are seeing that HER2- directed therapies are improving. With time were seeing better biologic treatments. There is a potential that we could get rid of some of the chemotherapy. Do we need to give everyone TCHP, I think, is the question. I think there are some patients who probably dont need all this chemotherapy and probably would be fine with single-agent taxane and dual HER2-directed therapy. The problem is, how do we identify who those patients are? And who really needs the full TCHP?

I think [its being thought of now as], Well, maybe we can use the achievement of pCR to help us figure that out. Could we, for example, as COMPASS is doing, take THP and give it a test run and see if it works? Does it give a pCR? If it does well, we did good. If it doesnt, then we need to escalate therapy, then we can give those patients who didnt get the pCR more treatment. Could they get AC, followed by T-DM1, for example? They would have completed AC-THP and T-DM1 as if they had received AC-THP preoperatively and then T-DM1 out back.

I think this is what were trying to learn, how can we tailor therapy. Were not quite there yet. Outside of clinical trials, I try to follow more textbook-like approaches, rather than these deescalation approaches, which I think should be reserved for trials at this point in time. I generally recommend TCHP.

What are some of these escalation/ deescalation strategies?

There are other trials that are ongoing in this space, and there are lots of deescalation approaches, [which try] to give less therapy. One deescalation approach could be to use T-DM1.

The KRISTINE trial [NCT02131064] had taken patients and randomized them to get TCHP or to get T-DM1 and pertuzumab. Technically the T-DM1 [arm], from a preoperative standpoint, had a higher pCR rate.4 But what was interesting to me is if you followed all the patients out for invasive disease-free survival [iDFS] after surgery, it was the same in both arms. So iDFS, if you follow people postop was exactly the same with T-DM1 + pertuzumab and TCHP.

The problem was in the preoperative setting. Some of the T-DM1 + pertuzumab patients had local regional progression, and those tended to be patients who had heterogeneous HER2 expression. If you think about it, these are patients who youre trying to get to pCR by just HER2-directed therapy. So, if they have any HER2 heterogeneity, its not going to work perfectly right. If you have a HER2-positive 2+ patient who is borderline FISH-amplified, T-DM1 probably isnt going to be a home run for this patient.

I think thats another issue thats going to come up as we try these deescalation approaches. Maybe it does need to be [an individual] who is strongly HER2-positive, 3+, to get away with an ADC [antibody-drug conjugate] such as T-DM1, which in my opinion, is much better tolerated than something [such as] TCHP and could be a wave of the future to try to deescalate therapy.

But on the flip side, I think were also trying to escalate treatment for the individuals who need it. There are trials ongoing trying to do more. One study, for example, in the high-risk population would be to potentially add immunotherapy to chemotherapy and HER2-directed therapy. There is a Roche study [NCT03135171] thats adding a tocilizumab [Actemra] to AC-THP in the preoperative setting. And there are some investigator-initiated trials also adding pembrolizumab to THP preoperatively.

There are some studies that are trying to replace trastuzumab with margetuximab [Margenza] in the preoperative setting, trying to escalate therapy. There is work on both sides of the spectrum, trying to get the right amount of treatment to the right patient. I think as we learn more, hopefully, well be able to do that. Its going to be interesting to see if well ever have biomarkers that will help us or if it will need to be something else.

There are some data that suggest early [PET scan] response could be a way to judge if youre giving an appropriately deescalated therapy. That could be a way to have early markers of response to know if we can get away with a little bit less.

Whats your approach to a suboptimal response pathologically after neoadjuvant chemotherapy?

This patient received TCHP and had residual disease. Generally speaking, I tend to give 14 cycles of T-DM1, as per the KATHERINE trial [NCT01772472], because we know that that will reduce chances of recurrence by about half.5 But if they achieve pCR, then I tend to complete HP-based therapy outback. I think the question that will arise is, do you give [a patient] neratinib [Nerlynx] after completion of adjuvant HER2- directed therapy?

We have data from the ExteNET trial [NCT00878709], for example, that showed that giving a year of neratinib after completion of trastuzumab did have a significant improvement in iDFS.6 I think my challenge is that that study was done at a time when we were not giving pertuzumab. We were not giving postrehab T-DM1. And so, we dont know what the benefit of neratinib would be in a modern-era patient.

That being said, the big benefit in ExteNET was in the hormone receptorpositive, HER2-positive patients, where, if you looked at the subgroup in that trial that had residual disease that was ER-positive and HER2-positive, there was a 7% absolute difference in iDFS and a trend toward survival benefit. And so, I have taken the stance, even though its completely not data driven, if [a patient] has ER-positive, HER2-positive disease and has residual disease after preoperative therapy, then goes on to complete their T-DM1 afterward, I offer neratinib.

What about the risk of diarrhea associated with neratinib?

[There are] some newer antidiarrheal approaches. The one that I tend to like best is the dose-escalation strategy, where you can start at just 2 pills a day and then escalate up a pill a week. [In my opinion,] just purine loperamide works well because patients tachyphylaxed to the diarrhea. If you start low and go up to full dose, Ive noticed that they tolerate that well.

In fact, in the CONTROL trial [NCT02400476], which looked at various antidiarrheal regimens with neratinib, that was the best- tolerated approach with the lowest rate of discontinuation.7 The other approaches include budesonide with loperamideso thats the oral steroid thats not absorbable or using colestipol, which is a bile acid sequestering [agent], and that works well with purine loperamide I find.

Any of those strategiescolestipol/loperamide, budesonide/ loperamide, or dose-escalation neratinibhave been much better than the days of using a purine loperamide, which doesnt work as [we have seen] with the 40% rate of grade 3/4 diarrheas reported in ExteNET.6

If this patient has pCR, would you still do trastuzumab and pertuzumab because of the nodal status?

We have no answer because no one has done that study to see if you could deescalate the pertuzumab in a pCR patient. But there was a large meta-analysis, where they looked at patients who had a pCR and they looked at their risk of recurrence, and they found that baseline nodal status and tumor size were still prognostic. They were still independent prognostic indicators, even in a pCR patient. Those patients with upfront nodal involvement still have a higher rate of recurrence than the upfront node-negative patient with pCR; their baseline risk is still prognostic.

In this patient who does have high-risk [disease], we know that pertuzumab-based therapy for a year, based on APHINITY, did [lead to] risk reduction.

What is next in terms of adjuvant therapies?

There are studies that are ongoing trying to see if we can do even better than KATHERINE. Certainly, KATHERINE was very impressive with a 3-year iDFS of 88% with a 50% risk reduction.5 But there still was no reduction in CNS [central nervous system] recurrences in KATHERINE. And if you look at the node-positive subgroup of KATHERINE, their iDFS was about 83% at 3 years. So, in my mind, theres still room for improvement in the high- risk, node-positive patients.

There are studies ongoing. One is called the CompassHER2-RD study [NCT04457596], which is looking at taking patients with residual disease and randomizing them to get T-DM1 or T-DM1 plus tucatinib [Tukysa] with the idea that there are some data to suggest tucatinib, the oral TKI [tyrosine kinase inhibitor] [works] synergistically with T-DM1. Could it enhance activity and potentially even prevent CNS recurrences, knowing that tucatinib penetrates CNS?

That study will take patients with residual disease, and, just [as in] KATHERINE, randomize them to T-DM1 with or without tucatinib. And then theres a study opening through NRG [Oncology], looking at trastuzumab deruxtecan [Enhertu] in patients with residual disease [DESTINY-Breast05; NCT04622319]. Its randomizing the residual disease patient to trastuzumab deruxtecan or T-DM1, again trying to escalate therapy for that high-risk patient.

I think well see more with time about whether we can do even better for the high-risk patients, but for now, outside of a trial, T-DM1 would be the standard.

What adjustments have you made in treatment as a result of the coronavirus disease 2019 (COVID-19) pandemic?

One thing our group has started thinking about is using subcutaneous HP [Phesgo]. There are now data that compared the IV [intravenous] and subcutaneous formulations in the preoperative setting [from] the FeDeriCa study [NCT03493854].

The pCR rates were the same [59.5% vs 59.7%].8 They looked at pharmacokinetics between the 2, and they were also the same. [In terms of] adverse events, there werent any significant differences. There was a little more skin reaction at the site of the injection with the subcutaneous [formulation], but outside of that no real differences in toxicity profiles.

The other thing that I think is interesting, and I think this is a pretty cool study, is a preference study called PHranceSCa [NCT03674112], where they took people who received IV HP and then switched them to subcutaneous or did the reverse. They asked [the patients what they preferred], because every patient had been exposed to either formulation, and [more than] 80% of people preferred subcutaneous when they had received both.9

Obviously, the chair time and infusion are a lot less if you just give a 10-minute push of both drugs, rather than having to give 2 IV drugs 30 minutes each. Our group has started switching people over. It turns out when we compared the cost of subcutaneous with IV, subcutaneous was [less expensive]. I think Roche was clever in the way they priced it to try to encourage utilization. I think there are even some more advantages to chair time in the infusion center by using subcutaneous.

Our new practice has been that when we start, for example, TCHP, we just give everyone the subcutaneous formulation instead of IV. And then Ive started offering my other patients who are in maintenance HP in the adjuvant setting after their pCR, for example, the subcutaneous version because they can be in and out of infusion much [more quickly].

We usually use the thigh [for the subcutaneous infusion], and youre supposed to rotate location. Its 1 shot, theyre both drugs are mixed into 1. Thats why its nice. The problem is, it is quite a bit of volume. And so, its, [for instance], 10 cc of fluid getting pushed subcutaneously and it has to be a very slow push for 10 to 12 minutes. So, its not like a quick subcutaneous push. But patients have really liked it.

There is a study ongoing where theyre sending nurses to [patients homes] and administering the HP there. I think particularly during COVID-19 theres a big push to figure out how to do home administration of drugs. And since so many patients are on maintenance afterward, its nice for them not to have to come into clinic so much. I think well see more about the feasibility of home administration, but for now, this has to be done by a nurse in our infusion center; its not something that can be done by patients at this time.

I also use the subcutaneous trastuzumab, as well. For example, when I give TH, Ive switched over to using just subcutaneous trastuzumab, because thats also quicker, particularly when youre on just the trastuzumab maintenance. After the first 12 weeks, thats in and out of infusion very fast. I havent had any insurance pushback, which is quite interesting, when using the subcutaneous trastuzumab formulation. Its gone through just fine.

The rest is here:
Use of Anthracycline or Nonanthracycline Therapy Is Considered in HER2+ Breast Cancer - Targeted Oncology

Diabetes is a group of diseases that negatively affect how your body uses glucose or blood sugar. This is an issue because glucose is important to our health, it is an important source of energy for our body. It is also a main fuel source for our brain. Individuals affected by diabetes can either have Type 1 diabetes or Type 2 diabetes or pre-diabetes.

In Type 1 diabetes, the body just doesnt make insulin. Typically, the body is supposed to break down carbs that are eaten into glucose that it then uses for energy, and insulin is the hormone that is necessary to get blood sugar from the bloodstream into the cells. The Centers for Disease Control and Prevention (CDC), estimates that around 1.6 million Americans have Type 1 diabetes, with about 187,000 of that number being children and adolescents. Type 1 diabetes can occur in anyone at any age and it affects every race, and people of every size. The exact cause of type 1 diabetes is unknown. What is known is that your immune system which normally fights harmful bacteria or viruses attacks and destroys your insulin-producing cells in the pancreas. This leaves you with little or no insulin. Instead of being transported into your cells, sugar builds up in your bloodstream. Type 1 is thought to be caused by a combination of genetic susceptibility and environmental factors, though exactly what those factors are is still unclear. Weight is not believed to be a factor in type 1 diabetes. There are resources available to anyone affected by it. This is a condition that can be managed, by practicing healthy lifestyle habits (exercise and proper diets). Individuals with this condition can live a full and normal life.

Type 2 diabetes is when the body doesnt use insulin properly, and this is the most common type of diabetes. Different people require different treatment plans, some people can control their glucose levels by eating healthy and exercising but some may need to use medication or insulin to help them. Either way, there are resources and support available to help everyone affected.

A large and important part of managing type 2 diabetes is maintaining a healthy diet and exercising. It is essential to find a diet that can be maintained, by finding a healthy diet that you actually enjoy. Fitness is also important, and thankfully there are many options available to those who want to get moving. Find activities that you enjoy doing and do them in your free time. Working with your physician to determine what physical activity level you can actually handle and that you should engage in, is a good first step to take to get active.

Another health condition related to diabetes is prediabetes. This is where your glucose levels are higher than normal but not quite high enough to be diagnosed as type 2 diabetes. According to the CDC, 88 million American adults have prediabetes, with more than 80% of them knowing that they have it. Prediabetes puts you at risk of developing type 2 diabetes, stroke, and heart disease. However, if you have prediabetes lifestyle changes can be made to delay or even prevent the onset of type 2 diabetes and the other serious health problems that prediabetes puts you at risk for.

Regardless of the type of diabetes certain signs and symptoms occur. They include increased thirst, frequent urination, extreme hunger, unexplained weight loss, presence of ketones in the urine (ketones are a byproduct of the breakdown of muscle and fat that happens when theres not enough available insulin), fatigue, irritability, blurred vision, slow-healing sores, frequent infections, such as gums or skin infections and vaginal infections. Ask your healthcare provider for help and testing if you notice any of these symptoms.

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Originally posted here:
LIVE WELL: The importance of knowing the aspects of diabetes - Stillwater News Press

Choosing to avoid meat and eat a plant-based diet has never seemed so virtuous and necessary. Between the intrinsic cruelty of industrial livestock production and livestocks climate footprintestimated by the U.N.s Food and Agriculture Organization to be 14.5% of all greenhouse gases world-wide, significantly greater than that of plant agricultureit has become increasingly difficult to defend the place of meat and animal-sourced foods in our diets. Jonathan Safran Foer, the novelist turned animal-rights activist, may have best captured this thinking in his 2019 nonfiction book, We Are the Weather: Saving the Planet Begins at Breakfast. As he writes, We cannot keep the kind of meals we have known and also keep the planet we have known. We must either let some eating habits go or let the planet go. It is that straightforward, that fraught.

An essential part of this argument is the proposition that animal-sourced foods, and particularly red and processed meats, arent just bad for the planet but harmful for the people who eat them. As the journalist Michael Pollan famously urged in his 2008 bestseller In Defense of Food, that is why we should eat mostly plants. This has become the lone piece of dietary counseling on which most nutritional authorities seemingly agree. It creates a win-win proposition: By eating mostly (or even exclusively) fruits, vegetables, whole grains and legumes, while getting our proteins and fats from plant-based sources, we maximize our likelihood of living a long and healthy life while also doing whats right for the planet.

But is it that simple? A growing body of evidence suggests it isnt, at least not for many of us.

The other food movement that has won increased acceptance over the past decade is the low-carbohydrate, high-fat ketogenic dietketo, for shortwhich has emerged as a direct response to the explosive rise in the incidence of obesity and diabetes. More than 70% of American adults are now obese or overweight, according to the Centers for Disease Control and Prevention; nearly one in 10 is severely obese, and more than one in 10 is diabetic. An unavoidable implication of these numbers is that the conventional wisdom on weight losseat less, move your body morehas failed tens of millions of Americans.

These are the people who, sooner or later, may well experiment with alternative approaches, venturing into the realm of fad diets. They may try plant-based eatingvegetarian or even veganand if those dont return them to health, try keto or one of the many variations on low-carbohydrate, high-fat diets, from the original Atkins diet to the South Beach diet to paleo to the latest trend, carnivore. If they find that an unconventional approach works for them, allowing them to achieve and maintain a relatively healthy weight without enduring hunger, that will be their motivation to sustain it. But because this way of eating is most easily accomplished with animal-sourced foods, they may come to believe that whats good for them (and even their children) isnt good for the planet.

See more here:
The Keto Way: What If Meat Is Our Healthiest Diet? - The Wall Street Journal

While regular use of contraceptives is the best choice to prevent pregnancy, emergency contraception is a safe way to prevent an unwanted pregnancy after having unprotected sex.

If you've recently had unprotected sex and are looking for emergency contraception your main options are:

Here's a breakdown of the pros and cons of each type and how to choose the best emergency contraception for you.

Levonorgestrel is a synthetic hormone that stops the release of the egg from the ovaries to prevent fertilization, says Julie Levitt, MD, a gynecologist at The Women's Group of Northwestern.While there are several popular brands, including Plan B One-Step, My Way, and After, the effectiveness is the same no matter which pill you take.

When can I use it? You can use levonorgestrel for up to 72 hours (3 days) after unprotected sex, but it is best to take the pill as soon as possible for better efficacy.

How effective is it? Numerous studies have found levonorgestrel to be 60% to 94% effective in preventing pregnancy depending on how soon you take the pill.

Do I need a prescription? No, you can buy the pill over the counter and most pharmacies or drug stores carry it.

Ella is an emergency oral contraceptive that contains a drug called ulipristal acetate. While it does not contain estrogen or progesterone, it is a single-dose steroid medication. Taking a single tablet prevents ovulation, delaying a woman from releasing the egg from her ovary.

When can I use it? Ella is effective up to five days (120 hours) after unprotected sex. Like the copper IUD, this method does not diminish over time, but it is best to take it as soon as possible to avoid ovulation. If you vomit within three hours after taking the pill, ask your medical provider whether you should take another one.

How effective is it? It's around 65% to 85% effective at preventing pregnancy depending on how soon you take the pill, says Bartz.

Do I need a prescription? Yes, you need a prescription for Ella. There are some certified online prescription services or contact your doctor as soon as you can after unprotected sex.

A copper intrauterine device, or IUD, is a small T-shaped frame that is inserted into the uterus. The device contains no hormones and instead copper keeps sperm from the egg, preventing pregnancy from occurring. This makes it a good option for those who are sensitive to hormonal side effects or can't use hormones due to medical conditions. The copper IUD can provide up t

When can I use it? You can use a copper IUD as emergency contraception up to five days (120 hours) after unprotected sex, but some studies have found it can be effective up to 10 days after.

How effective is it? The copper IUD is the most effective emergency contraception, says Deborah Bartz, MD, MPH, a gynecologist at Brigham and Women's Hospital in Boston, MA. It is over 99% effective in preventing pregnancy and works just as effectively on day one as day five.

Do I need a prescription? No, you do not need a prescription, but a copper IUD must be inserted by a medical professional, such as a women's doctor or nurse. It may be challenging to rely on this method because it requires a prompt appointment.

Birth control pills are an oral contraceptive that contains the hormones estrogen and progestin, which prevents pregnancy by blocking the release of the egg from the ovaries. While these pills are normally taken as a form of daily birth control, they may be also used as emergency contraception after unprotected sex. This is known as the Yuzpe regimen.

There are many different types of birth control pills some with hormone levels that change each week, others with a steady dose daily. For this reason, the exact number of tablets to take for the first dose may vary, and a second dose is generally taken 12 hours later.

The exact dosage needed in total is 200 mcg Ethinyl estradiol the estrogen component and 1 mg progesterone. However, it is not recommended that you do this independently due to the irregularity of the dosing and the high possibility for side effects. Speak with your OBGYN to determine if this is the right method for you to pursue.

When can I use it? The Yuzpe regimen is effective up to 72 hours (3 days) after unprotected sex, but it is recommended to use only if the other contraceptive methods are not readily available. You should also only use it under the direction of a healthcare provider.

How effective is it? Much like the other oral contraceptives, the longer you wait to take the birth control dose, the less effective the method will be. The American College of Obstetricians and Gynecologists no longer recommend this method because it is the least effective (with an average of 74% effectiveness) and has high side effect risks, such as nausea and vomiting.

Do I need a prescription? Yes. You can get a prescription from a healthcare professional, such as an OBGYN, a physician at a Planned Parenthood, or a licensed pharmacist.

When considering which emergency contraception to use, there are some factors to keep in mind.

When you last had sex: Non-hormonal contraceptives, i.e. Ella and the copper IUD, can work up to five days after, or possibly longer, while most hormonal options plan B and the pill are limited to 72 hours.

Weight: If you weigh more than 155lb, pills containing levonorgestrel, like plan B, may be less effective, and you should ask your doctor for an Ella prescription. However, if you weigh over 195 lbs, Ella may not be as effective.Weight has no effect on the copper IUD.

What research says: A 2015 study found that the rate of pregnancy in women over 165 lbs increased significantly (5% to 6%) when taking levonorgestrel. Another large 2012 study found the rate of pregnancy in obese women increased by 7% when taking ulipristal acetate.

Affordability and accessibility: Generally, contraceptives with levonorgestrel are the easiest to find. Meanwhile, Ella is less common in pharmacies and requires a prescription.

Planned Parenthood can be an affordable option for emergency contraception, says Levitt, since they are able to provide care at a lower cost. The organization also has a nifty quiz you can take to determine which emergency contraception is right for you.

Emergency contraception after unprotected sex can come in non-hormonal and hormonal options that vary in effectiveness and method. Choosing which is best for you can depend on various factors, such as weight, when you last had sex, and accessibility, and should be discussed further with your healthcare provider.

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Emergency contraception: Which type is best for you? - Insider - INSIDER

Investigators are seeking to determine whether amcenestrant (SAR439859), an investigational oral endocrine therapy, can generate meaningful antitumor activity when administered as short-term preoperative therapy to postmenopausal patients with newly diagnosed early breast cancer.

The phase 2 AMEERA-4 trial (NCT04191382) is testing 2 dose levels of amcenestrant versus letrozole given for 14 days to patients with estrogen receptor (ER)-positive, HER2-negative localized breast cancer who are candidates for breast conserving therapy or upfront mastectomy.1

The study will measure the impact of the short course of endocrine therapy on Ki-67, a protein biomarker of cellular proliferation that has been shown to be a prognostic indicator of survival and recurrence in patients with early breast cancer, with higher levels associated with worse outcomes.2

Ki-67 expression has been correlated with poor cancer-specific survival at a cutoff point greater than 14% of tumor nuceli.3 AMEERA-4 is a window of opportunity study, a validated strategy for rapid exploration of proof-of concept treatment approaches, investigators said in a poster presentation at the 2020 American Society of Clinical Oncology Virtual Scientific Program.4

The trials goals include determining the best dosage for further study of amcenestrant in this clinical setting, said principal investigator Mario Campone, MD, a medical oncologist at the Institut de Cancrologie de lOuest, Ren Gauducheau, in St Herblain, France.

Some clinical trials have demonstrated that when you have a decrease in Ki-67 after 2 weeks you have a better outcome compared with the patients who do not have a decrease in this surrogate marker, he said in an interview with OncologyLive.

Amcenestrant is a selective ER degrader (SERD), a class of drugs that works by serving as a competitive antagonist to the ER, inducing conformational changes that lead to degradation of the receptors. In preclinical studies, the agent has demonstrated antitumor efficacy and regression in ER-positive breast cancer models.5 Further, amcenestrant can be administered as an oral therapy because of its favorable pharmacokinetic profile, as opposed to fulvestrant (Faslodex), a SERD that must be given via intramuscular injection because of pharmacokinetic limitations.5,6

AMEERA-4, an international, open-label study, was initiated in December 2019 and is being conducted at 16 active sites with 34 planned sites, Campone said.

Participants are being randomized 1:1:1 to receive daily amcenestrant at 400 mg, daily amcenestrant at 200 mg, or daily letrozole at 2.5 mg for 14 days, with the last dose administered on the day before surgery. Biopsies are performed at baseline and during surgery (FIGURE).1,4

The primary end point is a change in Ki-67 expression measured by immunohistochemistry after a 14-day treatment period compared with baseline levels. Secondary end points include the proportion of patients with relative decrease from baseline in Ki-67 expression of 50% or more, change in ER expression compared with baseline, and safety and tolerability.

Efficacy will be assessed via pathological complete response (pCR), which is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary nodes after treatment. ECOG performance status response will be measured after the 14-day treatment based on breast tumor shrinkage and pCR. Additionally, a preoperative endocrine prognostic index derived from pathologic tumor and node stages, Ki-67 levels, and ER status of the surgical specimen will be assessed after the 14-day treatment period.

Investigators are seeking to recruit 126 patients for the study. So far, 14 patients have been enrolled, and the study could be completed sometime this year, with data analysis projected for 2022, Campone said.

After completion of the AMEERA-4 study, Sanofi, the agents developer, plans to initiate a pivotal clinical trial to study amcenestrant in early breast cancer.7 AMEERA-6 will be a registrational study with invasive disease-free survival as the primary end point. This study will be supported in part by data generated from AMEERA-4, which is expected in to be available in 2021, according to a Sanofi spokesperson. AMEERA-6 is expected to begin recruiting patients by the end of 2021.

The use of amcenestrant as monotherapy has shown encouraging signals in the ongoing phase 1/2 AMEERA-1 trial (NCT03284957). In interim results reported at the 2020 San Antonio Breast Cancer Symposium, amcenestrant monotherapy elicited antitumor activity in heavily pretreated, postmenopausal women with advanced or metastatic ER-positive breast cancer.8

Results showed that the objective response rate (ORR) was 8.5% with amcenestrant with a clinical benefit rate (CBR) of 33.9% among pooled results from 59 patients who received amcenestrant at 150 mg or more daily. In a cohort of 33 patients who had received 3 or fewer prior lines of therapy in the metastatic setting, the ORR was 15.2% and the CBR was 42.4%. Moreover, in a subgroup of 14 patients who did not receive prior CDK4/6 inhibitors, mTOR inhibitors, or fulvestrant, the ORR was 21.4% and the CBR was 64.3%.8

In AMEERA-1, which is a first-in-human study, investigators are evaluating the safety and efficacy of amcenestrant as a single agent and in combination with targeted therapies in patients with ER-positive, HER2-negative metastatic breast cancer. In part A of the trial, which was the dose-escalation phase, investigators evaluated amcenestrant at oncedaily doses ranging from 20 mg to 600 mg. In part B, which was the dose-expansion phase, the recommended dose for amcenestrant as monotherapy was determined to be 400 mg once daily.

Amcenestrant was found to have a favorable safety profile with 62.9% of patients experiencing treatment-related adverse events (TRAEs), none of which were grade 3 or higher. The most common (5%) TRAEs in the pooled population of patients who were treated with amcenestrant at the 150-mg or higher daily dose included hot f lush (16.1%), constipation (9.7%), arthralgia (9.7%), decreased appetite (8.1%), vomiting (8.1%), diarrhea (8.1%), nausea (8.1%), and fatigue (6.5%).8

Pivotal results are expected in the f irst half of 2021, according to Sanofi. Amcenestrant as a monotherapy may be available as a second- and third-line treatment for patients with metastatic breast cancer in 2022, the company said.7

Amcenestrant monotherapy is also being evaluated versus physicians choice of therapy in the open label, phase 2 trial AMEERA-3 trial (NCT04059484), which will enroll 372 patients. The control treatment involves choosing monotherapy from a list of agents with different mechanisms of action: anastrozole, letrozole, or exemestane, which are aromatase inhibitors; tamoxifen, a selective estrogen receptor modulator; or fulvestrant. The primary end point is progression-free survival (PFS). Secondary end points include OS, ORR, disease control rate, CBR, and duration of response (DOR).9

Another study, AMEERA-5 (NCT04478266), is testing amcenestrant in combination with palbociclib (Ibrance), a CDK4/6 inhibitor, versus letrozole plus palbociclib as a first-line therapy for patients with ER-positive, HER2negative locoregional or metastatic breast cancer. The study, which aims to recruit 810 patients, has a primary end point of PFS and secondary end points of OS, ORR, DOR, and CBR.10

Additionally, the Quantum Leap Healthcare Collaborative announced in June 2020 that amcenestrant was selected to be part of a new I-SPY 2 study arm.

The study, known as the I-SPY 2 Endocrine Optimization Protocol (EOP), is focused on patients with molecularly low-risk, clinically high-risk, hormone receptorpositive, HER2negative clinical stage II or III invasive breast cancer. Amcenestrant will be tested as a monotherapy and in combination with up to 3 other agents.11

The I-SPY program was designed to identify therapies that are most effective in specific patient subgroups based on biomarker signatures. Sanofi is supplying the drug and providing financial support.

Original post:
Trial Explores Preoperative Window for Amcenestrant Therapy in Early Breast Cancer - OncLive

Introduction

Obesity is an important chronic disease all over the world because of the increasing prevalence and harms to public health. Obesity can result in multiple alterations in the endocrine systems, including altered circulating blood hormone concentrations, because of changes in the pattern of secretion and/or metabolism, abnormal hormonal transport, and/or actions at levels of target tissues.1 It has been demonstrated that obesity has an impact on male reproductive system. And obesity has been considered as a risk for male hypotestosteronemia with low testosterone levels. It has been reported that there are 2064% of obese men with low total testosterone (TT) or free testosterone (FT) levels.2 Related studies have reported that the increasing BMI is associated with low testosterone and sex-hormone-binding-globulin (SHBG) levels in the male population.36 Weight reduction by lifestyle intervention or bariatric surgery can increase the levels of TT and SHBG.3

Metabolic syndrome (MS), gathering of abdominal obesity, hypertension, hyperglycemia, and dyslipidemia is an important challenge for health problem. The prevalence of metabolic syndrome ranges from 1034% according to different definitions or populations.7 Several studies have pointed that metabolic syndrome can be regarded as an independent association with low levels of total testosterone in males.811 And low levels of TT and SHBG can be considered as independent risk factors for metabolic syndrome.12,13 However, the relationship of TT with metabolic syndrome remains inconsistent. A cross-sectional study reported that there was no significant difference of total testosterone among MS and non-metabolic syndrome group. It is supposed that the other parameters were abnormal, the lower levels of SHBG would be measured, without alternations of TT.14 And several studies have concluded that their data were not consistent with the hypothesis that low levels of TT were associated with incidence of metabolic syndrome.15,16

Recent studies have demonstrated that not all obese individuals have metabolic abnormal risk factors, and not all lean individuals are metabolically healthy.17 Therefore, different metabolic phenotypes of obesity have attracted researchers attention in recent years. Although obesity may induce decreased serum TT concentration by some related mechanisms, the fact is that only a small proportion of obese men are hypotestosteronemia, probably those genetically predisposed or morbidly obese.18 Metabolic healthy overweight/obesity (MHO) is considered to be overweight/obesity (BMI25 kg/m2) without metabolic diseases (hypertension, type 2 diabetes mellitus (T2DM), and dyslipidemia). In addition, metabolically unhealthy overweight/obesity (MUO) refers to a proportion of overweight/obese subjects with metabolic diseases. A recent study based on 4,945 men with sexual dysfunction and 231 male partners of infertile couples demonstrated that men in the MHO groups had lower total testosterone levels compared to men of normal weight.19 However, the effect of specific metabolic obesity phenotypes on total testosterone in the general male population remains unknown. Hypotestosteronemia is classified into primary hypotestosteronemia which results from testicular defects and is associated with low testosterone levels and elevated LH and FSH levels and secondary hypotestosteronemia which results from dysfunction of hypothalamus and/or pituitary and refers to patients with low testosterone levels and low or inappropriately normal LH and FSH levels. And whether the influence of different metabolic obesity phenotypes on TT levels is caused by affecting hypothalamus and/or pituitary levels or testicular levels remains unknown.

Thus, we performed the study to verify the separate influence of MS and overweight/obesity on male hypotestosteronemia, and investigate the relationship of different metabolic obesity phenotypes and male total testosterone levels in a large-scale male population.

We recruited nearly 11,000 persons who participated in the population-based cross-sectional study in Ningyang County (Taian, Shandong Province, China) from June to November 2011. All participants were local-registered residents aged 40 years and older who have lived there for at least 5 years. All participants were asked to complete a self-reported questionnaire and provided an overnight fasting blood sample. In our study, the exclusion criteria were as follows: i) female; ii) no information on vital statistics (such as age, sex, height, or weight) or missing data on serum total testosterone (TT), blood pressure, fasting serum glucose, or lipid levels; iii) taking medications that might affect TT level (such as androgens, steroid hormones); and iv) severe hepatic or renal disorders, lung diseases, hypothalamus and/or pituitary gland diseases, neurologic diseases, or tumors that might affect TT level (such as brain cancer or prostate cancer). At last, a total of 4,081 participants were recruited in this study. The study protocol conformed to the 1975 Declaration of Helsinki and was approved by the Committee on Human Research at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. All study participants provided written informed consent.

Height and WC were measured adjusting by 0.1 cm. Weight was measured adjusting by 0.1 kg. BMI was obtained by dividing weight in kilograms by the square of height in meters. The average of the three blood pressure measurements in sitting position after a 5-minute rest was used in the analysis. Past medical history, smoking status, and alcohol consumption were obtained by a questionnaire. The diseases (hypertension, diabetes mellitus, and coronary heart disease) were based on previous diagnosis by a physician. Smoking status and alcohol consumption were defined as never, ever, and current.

Venous blood samples were collected from all patients after at least 10-hours overnight fast and samples were separated and preserved in 80C. The concentrations of total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), fasting plasma glucose (FPG), and glycosylated hemoglobin (HbA1c) were measured directly with an ARCHITECT ci16200 Integrated System (Abbott). Serum TT, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) were measured using electrochemiluminescent procedures (Cobas E601; Roche) at the clinical laboratory of Shandong Provincial Hospital.

Total testosterone level <12 nmol/L is suggestive of hypotestosteronemia.20 Secondary hypotestosteronemia refers to patients with low testosterone levels and low or inappropriately normal LH and FSH levels. Primary hypotestosteronemia is associated with low testosterone levels and elevated LH (>8.6 mIU/L) and FSH (>12.4 mIU/L) levels. We used the Adult Treatment Panel III definition of metabolic syndrome in male population: having three or more following criteria: waist circumference >102 cm, triglycerides >1.7 mmol/L (or treatment for hyperlipidemia), HDL-C <1 mmol/L, plasma fasting glucose >100 mg/dL, and systolic/diastolic blood pressure >130/85 mmHg (or treatment for hypertension).21 And we classified the population as normal weight (BMI<25.0) and overweight/obesity (BMI25.0) with or without metabolic syndrome. Then, according to a previous study, the participants were classified as four groups: metabolically healthy normal weight (MHNW) (BMI<25.0, without metabolic syndrome); metabolically healthy overweight/obese (MHO) (BMI25.0, without metabolic syndrome); metabolically unhealthy normal weight (MUNW) (BMI<25.0, with metabolic syndrome), and metabolically unhealthy overweight/obese (MUO) (BMI25.0, with metabolic syndrome).22

SPSS22.0 software was used for the statistical analysis. Continuous variables were presented as meanstandard deviations, and between-group differences were assessed by a single-factor analysis of variance (ANOVA). Categorical variables were presented as percentages, and between-group differences were assessed by Chi-squared test. Multiple logistic regression analysis was performed to assess the risk factors of hypotestosteronemia. All P-values were 2-sided, and less than 0.05 were considered statistically significant.

A total of 4,081 male participants aged from 4075 years were enrolled into the final analysis. There were 563 participants suffering from hypotestosteronemia (13.80%). Within metabolic categories, overweight/obese men tended to be younger with a high level of BMI and WC than men with normal weight. And overweight/obese men were more likely to have a high level of TC, TG, LDC-C, ALT, GGT, and DBP, and a low level of HDL-C, TT, LH, and FSH, without difference of AST, FBG, and HbA1C. As expected, compared to the metabolic healthy group, metabolic unhealthy patients were more likely to have a high level of TG, TC, ALT, AST, GGT, FPG, HbA1C, systolic blood pressure, and diastolic blood pressure, and a low level of HDL-C and TT. There was a high prevalence of diabetes mellitus, hypertension, and coronary heart disease in the metabolic unhealthy population. Compared to the MHNW group, the MHO, MUNW, and MUO groups tended to have a high level of BMI, WC, elevated liver function index, altered metabolic syndrome components, and high risk of developing hypertension and coronary heart disease, as well as decreased levels of serum TT, LH, and FSH (Table 1). There was no significant difference of serum testosterone level between the MHO and MUNW groups. The significant differences in the composition of the four groups with respect to smoking status and alcohol consumption are also shown in Table 1.

Table 1 Baseline Characteristics in Different Metabolic Obesity Phenotypes

To compare the difference of prevalence of hypotestosteronemia among different metabolic obesity phenotypes, we performed a Chi-squared test between each two groups. We observed an obvious elevated trend of prevalence of hypotestosteronemia in these four metabolic obesity phenotypes in Figure 1. Compared to the MHNW group, the other three groups have been demonstrated to have a higher risk of hypotestosteronemia. At the same time, compared to the MUO group, the other three groups were more likely to have a lower risk of hypotestosteronemia. However, no difference existed between MUNW and MHO group (Figure 1A). The results of comparison of prevalence of secondary hypotestosteronemia in four groups were similar to hypotestosteronemia (Figure 1B). However, the prevalence of primary hypotestosteronemia in the MHNW and MHO groups was significantly lower than in the MUO group. No significant difference existed in the prevalence of primary hypotestosteronemia in other groups (Figure 1C). These differences demonstrated that different metabolic obesity phenotypes could have different impacts on serum testosterone levels.

Figure 1 (A) Prevalence of hypotestosteronemia in different metabolic phenotypes of obesity; (B) Prevalence of secondary hypotestosteronemia in different metabolic phenotypes of obesity; (C) Prevalence of primary hypotestosteronemia in different metabolic phenotypes of obesity. Metabolically healthy normal weight (MHNW); metabolically healthy overweight/obese (MHO); metabolically unhealthy normal weight (MUNW), and metabolically unhealthy overweight/obese (MUO). (Graph pad prism8 used to create the artwork.)

To examine the separated and synergistic effect of overweight/obesity and metabolic status on serum TT concentration, we carried out multivariate logistic regression analysis of hypotestosteronemia with low serum TT levels (<12 nmol/L) adjusting for age, LH, smoking status (never, ever, current), and alcohol intake (never, ever, current). Both overweight/obesity and metabolic syndrome, considered separately, were risk factors of low serum TT levels. The multivariate-adjusted Odd Ratio (OR) of low serum TT levels in overweight/obesity men was 3.072 (95% CI= 2.4143.911). The risk of low serum TT levels increased appropriately 3.294-fold in metabolic syndrome individuals compared to metabolic healthy individuals (Table 2). Although the risk of hypotestosteronemia in overweight/obesity and metabolic syndrome individuals was attenuated after mutual analysis, the OR of low serum TT levels remained statistically significant adjusting for age, LH, smoking status (never, ever, current), and alcohol intake (never, ever, current) (Table 2).

Table 2 Adjusted Correlations of BMI and Presence of the MS with Total Testosterone

Table 3 Logistic Regression Analysis of Hypotestosteronemia According to Different Metabolic Phenotypes of Obesity

To study the independence of different metabolic obesity phenotypes for male hypotestosteronemia, we performed logistic regression analysis to observe the OR of hypotestosteronemia in four groups. Compared to participants in the MHNW group, the risk of developing hypotestosteronemia in the MHO, MUNW, and MUO groups significantly increased. ORs of hypotestosteronemia in the MHO, MUNW, and MUO groups were 2.736 (95% CI=2.1323.512), 3.332 (2.3144.799), and 6.213 (4.8427.972), respectively (Table 3). After adjusted for age, OR of hypotestosteronemia in MHO and MUO groups decreased, but it was still significant. Male subjects in the MHO, MUNW, and MUO groups also had a significantly increased risk of hypotestosteronemia in contrast to those in the MHO group after adjusted for age, LH, smoking status (never, ever, current), and alcohol intake (never, ever, current).

Obesity and metabolic syndrome are both considered to be risk factors of low serum TT levels. We provided precise insight into the association between different metabolic obesity phenotypes and low serum TT levels in a large-scale population of Chinese men aged from 4075 years old. It demonstrated that individuals with different metabolic obesity phenotypes including MHO, MUNW, and MUO, respectively, can all have a higher risk of developing low serum TT levels, especially significantly in the MUO group.

In our study, we draw a conclusion that both overweight/obese men and metabolic unhealthy men had a higher risk of developing low serum TT levels than normal weight and metabolic healthy individuals, which is consistent with the results in previous studies.811,13 It demonstrated that serum TT levels in the male population were associated with BMI and different components of metabolic syndrome. A Korean study has shown that serum TT levels were negatively associated with BMI, WC, FPG, TG, and blood pressure, and positively associated with HDL-L levels.11 A meta-analysis that included 9,525 men of different ethnicities proved that serum TT levels were negatively correlated with each component of metabolic syndrome.8 It has been reported that hyperinsulinemia which was associated with metabolic syndrome can inhibit the secretion of testosterone through insulin receptors which were expressed on Leydig cells.23 And excess adiposity tissue could lead to high levels of leptin, which can inhibit the steroidogenesis and the secretion of testosterone. Inflammatory cytokines, especially IL-1, IL-6, and TNF-, which were elevated in obesity or metabolic unhealthy individuals, can directly inhibit the steroidogenesis and subsequent testosterone production.24 Although there are several studies investigating the association of overweight/obesity and metabolic syndrome components with testosterone levels separately, there is still quite a gap in the literature considering the relationship between different metabolic obesity phenotypes and total testosterone levels.

As we have proved, different metabolic obesity phenotypes except for the MHNW group are at a high risk of developing low serum TT levels. Among these groups, MUO individuals are more likely to have a low level of serum TT than others. Studies have demonstrated that age, smoking status, and alcohol consumption were associated with different metabolic obesity phenotypes.25,26 However, after adjusting these above confounding factors, the relationship between TT levels and metabolic obesity phenotypes remained significant. To the best of our knowledge, the only study on this topic was performed to explore male sexual dysfunction with different metabolic obesity phenotypes.19 It showed that the men with MHO and metabolically complicated obesity (MCO) had lower testosterone levels and only MCO men had worse erectile function compared with normal weight men. However, the results were derived from male patients with sexual dysfunction or infertility, which could have different characteristics compared with the general male population. Whats more, the definition of MCO was the presence of at least one abnormality among hypertension, low HDL-C, and diabetes in obese men, and the contrast group was men with normal weight regardless of metabolic status.

In our study, there was a higher risk of developing hypotestosteronemia in male patients in MHO compared to the MHNW group, but a lower risk than the MUO group. MHO individuals referred to overweight/obese people without the risk factor of metabolic syndrome, and several studies have reported that these individuals were fat but fit with more favorable inflammatory and metabolic profiles.27 However, the recent systematic review and meta-analysis showed that MHO subjects had an increased risk for the development of cardiovascular diseases and all-cause mortality in contrast to MHNW subjects.28 And our results indicated that MHO individuals had a decreased total testosterone level compared to MHNW individuals. It has been reported that metabolic healthy obese individuals have certain differences in multiple aspects, such as fat distribution, inflammatory status, insulin resistance, and postprandial lipemia, compared with metabolic unhealthy obese individuals.29,30 Compared with MUO individuals, MHO was shown to have increased subcutaneous fat relative to visceral fat, lower liver fat, and insulin sensitivity. Excessive visceral fat or insulin resistance rather than general adiposity in obese individuals were at high risk of developing pre-diabetes and type 2 diabetes mellitus. Metabolic healthy subjects displayed lower postprandial response of plasma TG and higher postprandial response of hs-CRP, compared with those metabolic unhealthy, independent of whether or not they were obese. We also observed that testosterone levels were decreased in male subjects with MUO compared to MHO. Clinical features and metabolism difference caused by metabolic healthy obesity phenotype can partly explain the alternations of testosterone concentration in MHO group compared to MHNW and MUO group. Since MHO is a dynamic state (with a significant proportion of MHO subjects progressing to MUO over time), it is necessary to encourage weight control in MHO phenotypes to prevent the development of metabolic related disease including hypotestosteronemia.

We also observed that testosterone levels in male subjects with MUNW were decreased compared to the MHNW group, but these were increased in the MUNW group compared to the MUO group, and no significant difference to the MHO group. MUNW individuals displayed several metabolic abnormal risks including insulin resistance, atherogenic lipid profiles, visceral adiposity accumulation, and lower physical energy expenditures, despite having a normal BMI, and eventually had the increased risk of cardiovascular disease.31 It has been reported that MUNW phenotype exhibited increased arterial stiffness and carotid atherosclerosis compared to MHNW or MHO subjects.32 And another report has shown that MUNW individuals had a higher risk of cardiovascular disease than MHO, as well as reduced morbidity and mortality.33 The MHO phenotype was associated with a better overall metabolic profile and less oxidative stress than that observed in MUNW individuals.34 In our study, there is no significant difference of testosterone levels between MUNW and MHO group, which indicated that both MUNW and MHO can exert an influence on total testosterone levels. The underlying mechanism needs further study. It was shown that male subjects in the MUO group have decreased serum TT levels compared to MHO and MUNW groups, which can be explained by synergistic effect of obesity and metabolic unhealthy on TT levels in patients with MUO. It also indicated that male patients with MHO or MUNW should pay attention to losing weight or improving metabolic status in order to prevent the further drop of TT levels.

It is well known that testosterones are mainly synthesized in Leydig cells, which could be modulated by hypothalamus-pituitary levels. In our study, we also found that gonadotropins FSH and LH were significantly reduced in MHO and MUO groups compared to MHNW. However, there was no significant difference of FSH and LH levels between MHNW and MUNW, as well as MHO and MUO groups. There was an increasing conversion of androgen precursors into estrogens by aromatase system in adipose tissue among obese male population. Inappropriate effects of increasing estrogens might reduce LH secretory mass per secretory burst without any alternation in burst number.35 The exact mechanism for decreased gonadotrophins in male obesity could also include leptin, inflammatory mediators, and hypothalamic kisspeptin affecting gonadotropins- releasing hormone secretion.36 These results indicated that low levels of gonadotropins can partly explain the decreasing total testosterone levels in obesity participants, but not affected by metabolic status. To observe the effect of metabolic obesity phenotypes on pituitary or testicular levels, we further compared the difference of prevalence of secondary hypotestosteronemia and primary hypotestosteronemia in four metabolic obesity phenotypes. It showed that the difference of prevalence of secondary hypotestosteronemia and primary hypotestosteronemia in four groups was similar to hypotestosteronemia. The results were confusing, which was inconsistent with the results that LH and FSH levels were only affected by obesity. Although we did not get information about the pulse and frequency of LH and FSH secretory, which also played an important role in regulating the production of testosterone levels. Therefore, further studies about the pulse and frequency of LH and FSH secretory, the alternations of structure and function in testis need to be performed in different metabolic obesity phenotypes.

This is the first study to investigate the relationship of different metabolic obesity phenotypes with serum TT concentration in a large-scale male population. In our study, other potential risk factors of low TT levels such as age, LH levels, smoking status, and alcohol consumption were taken into account to make the result more convincing. However, several limitations also existed in our study. We did not obtain information about other sex hormones such as SHBG and estrogen, which can have an effect on TT levels. Meanwhile, we cannot draw a conclusion about the association of different metabolic obesity phenotypes and other sex hormones. Whats more, the cross-sectional study was unable to detect any causal relationship between different metabolic obesity phenotypes and testosterone levels. Large prospective studies are needed to validate this relationship.

In conclusion, both overweight/obesity and metabolic abnormalities are important risk factors for low serum TT levels. Different metabolic obesity phenotypes have influence on lower serum testosterone level in different degrees, especially in the MUO group with a lowest serum TT concentration. Male subjects in the MHO and MUNW groups had significantly decreased testosterone levels compared to the MHNW group, however, there was no significant difference of testosterone levels between the MHOand MUNW groups. Clinical physicians should pay attention to the weight combined with metabolic status of patients when we explore the reason of decreasing concentration of serum TT in male populations. Individual weight control and prevention of metabolic syndrome may be used for the primary prevention of male hypotestosteronemia. Patients with low level of serum TT can improve by losing weight or improving metabolic status.

The data used to support the findings of this study are available from the corresponding author, Qingbo Guan, upon request.

The research used data collected as part of a longitudinal study (REACTION) which was a multi-center, prospective, observational cohort study in Chinese people. We gratefully acknowledge the REACTION study group for organizing the national epidemiological REACTION study in China.

This work was supported in part by grants from the National Natural Science Foundation of China (81770860, 81471078 and 81641030) and Key Research and Development Plan of Shandong Province (2016GSF201007).

The authors declare that there is no conflict of interest.

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Abu Dhabi: For decades, cancer has evoked fear. The first mention of the disease can be paralysing for both patients and families, and overcoming the fear of mortality to fight it is often one of the hardest battles.

On the occasion of World Cancer Day, marked internationally on February 4, experts say that advances in the diagnosis and treatment of various cancers should help people take positive action when faced with the disease. This includes being proactive about screening, and seeking treatment even during a global pandemic, they say.

Dr Humaid Al Shamsi

Even today, many people in the Middle East avoid discussing cancer. But we need to talk much more about it, and make people more familiar with screening requirements.

"The best way to beat cancer, after all, is to live healthy and screen early, Dr Humaid Al Shamsi, president of Emirates Oncology Society and director of oncology at Bujeel Cancer Institute, told Gulf News.

In the UAE, 4,500 new cancer cases are diagnosed each year, with cancers being the third leading cause of death after cardiovascular illnesses and injuries.

Dr Arun Karanwal, medical oncology specialist at Prime Hospital, reminded that beating cancer is about focussing on the fight and not the fright.

Dr Arun Karanwal

In the last decade or so, there has been an overall improvement in five-year cancer survival rate from 50 per cent to 55 per cent. More importantly, when diagnosed in early stages, the five-year survival rate is more than 90 per cent for Hodgkins lymphoma, breast cancer, testicular cancer and prostate cancer, Dr Karanwal said.

Tremendous headway in cancer therapy today even allows for some kinds of cancers to be managed.

While cancer may still be a serious illness, more and more types of cancers are being managed as chronic diseases, like high blood pressure and diabetes. It still needs to be managed, and new methods of control are certainly needed, but the advances of the past 20 to 30 years have really allowed many people to live with their cancer, said Dr Mustaqeem Siddiqui, haematologist and consultant at Department of Haematology and Oncology at Sheikh Shakhbout Medical City (SSMC).

Dr Siddiqui added that advances have been seen in the treatment of all kinds of cancers

Dr Mustaqeem Siddiqui

While it is true some cancers have had more advances than others, I am hopeful that we will come to a day where all cancers will see drastic improvements in survival rates. I believe what has enabled this improvement in survival is continued investment in understanding basic biology, understanding how cancer develops, understanding how a cancer cell behaves, and understanding how the cancer affects our body including the immune system, he explained.

On World Cancer Day, the physician, who has long been involved in cancer research with the Mayo Clinic, also extended his gratitude to cancer patients who have participated in clinical studies.

What is cancer?

Cancer is a large group of diseases that can start in almost any organ or tissue of the body when abnormal cells grow uncontrollably, go beyond their usual boundaries to invade adjoining parts of the body and/or spread to other organs. The latter process is called metastasizing and is a major cause of death from cancer. A neoplasm and malignant tumour are other common names for cancer.

They are true trailblazers on the forefront of treating cancer and their experiences have informed how we treat cancer today. It is my hope that with continued support of research and clinical studies, one day cancer will be a footnote in history, he added.

A number of survivors discussed their challenging journeys with Gulf News on the occasion. And while each involves its own trajectory, what shines through is the way all of them advocated for their own health.

Lung cancer: I didnt understand how my cancer could possibly be treatable

The rest of the world was battling a pandemic, but Karen Johnsons position was even more complicated.

Just before cities around the world had come to a halt, on January 19, 2020, Johnson was diagnosed with Stage IV lung cancer. Specifically ALK-positive non-small cell lung cancer, a type of cancer that is typically detected in its advanced stages.

Usually, Im the most positive person I know. I thrive on challenges and look for the good in everyone and everything. But being told I had cancer was a whole different kind of challenge. I was in new territory, and scared. I even lost my positive self for a short while, the 49-year-old British sales and education executive told Gulf News.

She was therefore tremendously surprised when her oncologist said that her cancer, which had spread from her left lung to her abdomen, pelvis and bones, was both controllable and treatable with a regimen of just pills.

My first question when I heard of my diagnosis was, How long do I have? And then I was prescribed eight miracle tablets to take every day, and an injection once a month, Johnson said.

Johnson had lost her younger sister to cervical cancer eight years ago, so the diagnosis was particularly scary. Added to that, the COVID-19 outbreak made the situation scarier. Not only did Johnson have to worry about her two children being unable to visit from miles away in the UK, she was worried that the cancer might make her more prone to contracting COVID-19.

In a way, the hardest thing Ive ever had to do as a mother was telling my children on a video call that I had cancer. I will never forget the look on their faces when I said those words I have cancer. Right after, I had to quickly reassure them and tell them it was controllable, but they both looked so hurt and helpless, Johnson said.

The children couldnt visit right away but Johnson began the treatment, which included eight pills to be taken every day, along with an injection every month. She also needed a session of radiotherapy to treat a brain lesion.

The treatment has significantly reduced her cancer, and Johnsons children a 26-year-old son and 29-year-old daughter were able to visit her during 2020.

She did face a setback when a particularly stubborn lesion required 15 sessions of radiotherapy, but Johnson believes that things will get better.

I had tremendous support from my husband, children and friends. In fact, my husband has been like my cancer PA, and oftentimes, he has arranged everything so that all I have to do is just show up for my doctors appointments. I was worried about the toll on my family, especially since my mom and sisters havent been able to meet me for more than a year. But I decided I was going to keep an I-will-beat-this attitude, and trust the professionals treating me, Johnson said.

She also credits her doctor Dr Humaid Al Shamsi with bringing humour into cancer, and helping her bear some of the mental toll of the illness.

With that being said, it was important for Johnson herself to find her own strength and positivity.

As clichd is it sounds, what helps is reminding myself that my diagnosis doesnt define me, and that it is just part of my journey, she added.

Colon cancer: I had to remove 30 centimetres of my colon

Ahmad Ayyash was convinced his low haemoglobin readings pointed to something, but his concerns were initially dismissed.

A general physician recommended he resolve the issue with simple iron tablets, but the 66-year-old senior management executive from Palestine persisted. In follow-up testing, another physician suggested he was losing blood, and recommended an endoscopy and colonoscopy to trace the source of the problem. That was when the cancer was discovered, affecting about five centimetres of his colon.

The word cancer still strikes a sense of fear, and I cannot say I was immune to it. But after the initial diagnosis, I decided to put my faith in medicine, and in my doctors, Ayyash told Gulf News.

He was first diagnosed in February 2017. A month or so later, Ayyash underwent surgery to remove 30 centimetres of his colon. The procedure was laparoscopic, and therefore only involved about four small cuts on his abdomen. But it left him in hospital for nine days, and relegated him to IV nutrition for eight or so days. Even beyond that, he was only able to stomach soft foods as his body recovered.

The best thing to do when you have a procedure that involves your digestive system is not to eat, so it was obviously not easy. But beyond then, I have recovered well, Ayyash said.

What also helped was that Ayyashs cancer had few effects that were visible, the father-of-four said.

My family would have been more worried had I been in visible pain, but thankfully, that was not the case with my cancer. I honestly feel like I discovered it by coincidence, and because I insisted that there was something that needed checking, Ayyash said.

Despite the initial dismissal of his symptoms, Ayyash went on to find much support from his physicians as well.

My surgeon Dr Sadir Alrawi, director of oncology at VPS Healthcare put me very much at ease. He told me that if I had to choose a cancer, Id rather choose this because it was treatable, he said.

Because his cancer was in its early stages, Ayyash did not require any chemotherapy or radiation.

In fact, the 30 centimetres of bowel that was resected included areas that looked cancer-free but may have been affected, Ayyash said.

Since the surgery, the 66-year-old has continued to live a largely regular life, still working in senior management. He is regular with his follow-up blood tests, as well as with an annual colonoscopy and CT scan.

But he did learn some important lessons from the experience.

Cancer should be viewed as a treatable disease as much as possible, and people should not be afraid to undergo screenings, or to insist when they believe something is wrong. After all, there really is a big difference in prognosis when a cancer is discovered at five months and when one is discovered at five years, Ayyash said.

He also urged primary health professionals not to ignore sudden changes in parameters like haemoglobin level.

In fact, I learnt to take any such changes seriously, and to pursue it till I am comfortable, he said.

Lymphoma: 'I chose not to Google survival rates'

It was after a routine meal that 53-year-old business development manager Ajay Chaturvedi first felt that something was wrong.

Feeling nauseated and suffering from diarrhea, he had gone to an emergency unit for treatment, and was sent home with medicines to treat what appeared very much like gastroenteritis a stomach bug.

Still, he sought out another physician, who discovered a swelling in his abdomen. Scans subsequently revealed that his spleen and liver were enlarged.

I was shocked to see how my mesenteric arteries, which deliver blood from the heart to the gastrointestinal tract, were sandwiched in cancerous, enlarged lymph nodes, Chaturvedi, an Indian expat, told Gulf News.

Further tests revealed that he was suffering from the initial stages of B-cell non-Hodgkins lymphoma a cancer that affects the bodys lymphatic system, which manages immune response.

I am a strong person, but along this journey, I sometimes found myself weak and broken. I needed support from friends and family, but eventually, I decided to concentrate on my work, and on beating this, Chaturvedi said.

Diagnosed in 2015, the Dubai resident was prescribed six sessions of chemotherapy.

I handled the first four sessions very well. But by the fifth one, I was anxious, stressed, weak. I remember distinctly how it was sometimes difficult to even get up once I had sat down in a chair. There was nausea and insomnia to counter, and after each session, I could barely walk for three to four days, Chaturvedi said.

Cancer support

The UAE has a range of cancer support groups and organisations, which help patients and families all the way from diagnosis and treatment until post-cancer therapy. -Friends of Cancer Patients: 06-5065542 -Bosom Buddies: bosombuddiesad.org -Brest Friends: 800-ALJALILA -Breast Cancer Arabia -Cancer Patient Care Society Rahma: 80090 In addition to these, various community organisations also provide support, including financial means for patients.

Mustering all his strength, he continued with the chemotherapy sessions, scheduled about three weeks apart, even though he lost his hair and felt wretched.

Fortunately, his friends and family were very encouraging, and kept reminding Chaturvedi that survival rates were as high as 70 per cent when his specific type of lymphoma was discovered early.

I would look up articles on the Internet, but I eventually chose not to read up about the cancer because it was easy to come across worrying figures and accounts, Chaturvedi said.

He received the cancer all-clear in October 2017, and still keeps a close watch on his blood count with regular tests and doctors visits.

I know I was scared, but eventually, I fought the fear and focused on conquering the illness. Having beat it, I would remind other people in the same position that there are today a multitude of targeted therapies and effective interventions, Chaturvedi said.

In addition to keeping a watch on himself, Chaturvedi has also since undergone genetic testing to check if his children are at risk.

I also derived a lot of strength from my family and friends, but I would urge anyone who feels alone to seek out the many cancer support groups in the UAE, he added.

Breast cancer: The UAE has very advanced cancer treatment options

Following the discovery of a lump in 2014, Sofia Khalid had undergone a lumpectomy. Within two years however, the then-51-year-old economist from Pakistan was once again in pain.

Insisting on a battery of tests, including an MRI, her physicians discovered a lobular invasive carcinoma in its very early stages.

My doctors told me that the cancer a slow-growing variety is rarely discovered in its first few stages, especially because it is not apparent through mammograms, physical exams or even ultrasound exams. I had however felt a lump in the same area, and even when everyone insisted it was just scar tissue, I insisted on further screenings, Khalid told Gulf News.

The diagnosis, Khalid said, nevertheless felt like a death sentence.

It felt like a bullet, especially since I had, for years, worried about a cancer. The first lump had turned out to be benign, but in 2016, I was convinced there was something more, she said.

According to her physicians, Khalids cancer was rare for women under the age of 60 years, and was hard to detect because the cancer tissue looks very similar to breast tissue.

Still, Khalid took charge of her treatment, and opted for a full mastectomy with reconstruction. One of her daughters flew down from Canada, as well as an aunt from Pakistan, and Khalid said her workplace remained extremely supportive throughout the ordeal.

Since her cancer had not yet spread, there was no follow-up chemotherapy or radiotherapy. Instead, Khalid was prescribed hormone therapy in the form of a daily pill.

When I consulted other experts, everyone told me I had been given some of the best medical treatment possible. The UAE does have very advanced cancer treatment available, and I was lucky to have access to it, Khalid said. The Malaffi health information system in Abu Dhabi helped her keep track of all her appointments, and to go through all the follow-up checks. Moreover, she was able to both have her cancer tissue removed, and her breast reconstructed, during a single procedure.

But the ordeal had brought along its own trauma, and Khalid signed up for psychotherapy to resolve her feelings of depression.

Its taken me three years to work on my mental health, and I am glad I have chosen to do it. An atmosphere of doom and gloom helps nobody, she said. The mother-of-four has also taken up regular exercise after her brush with cancer.

Following her experience, Khalid advised that women advocate for their own health.

Had I not insisted on so many tests or discussed my concern repeatedly with my doctors, the cancer might not have been discovered so early. What I learnt was that if there are cancer symptoms, you may already be too late. So it is important to be proactive all the time, she urged.

I keep looking over my shoulder

Shyam A. Krishna, Senior Associate Editor

It will be back, the doctor said, referring to my lymphoma. That was eight years ago. Cancer hasnt returned, but Im still worried. I guess, the fear will always remain.

I do blood tests every six months, and a CT scan annually. So far, Ive been cancer-free. But every time I have a sore throat (from acid reflux), I involuntarily check my lymph nodes in the neck. Whenever I have a shaft of pain anywhere in my abdomen, the alarm bells keep ringing.

Call it hypochondria or survival instinct; I make more visits to my gastroenterologist than necessary. Thats more for my GERD (Gastroesophageal Reflux Disease). He was the one who diagnosed my cancer even after the initial battery of tests turned up nothing. The pain in my lower abdomen kept recurring every week. As the final throw of dice, the doctor called for a CT-Scan that revealed a growth in a lymph node. Non-Hodgins Lymphoma, that was the diagnosis. Immunotherapy and radiotherapy helped heal.

How was my cancer journey? What did I learn from it? Not much. Whatever little I learned, I forgot. Because life became normal. Im reminded of my cancer only when the reminders for the tests pop on my phone. Yet, there are moments when I look back at the dark days with trepidation. And realise how lucky I was.

My doctor called it the best cancer anyone can get. Its treatable, he added. Those words helped calm me. Later during my intense research on the internet, I found that its treatable but not curable. Which means theres no 100% cure. So when the oncologist warned me that it might return I wasnt surprised. By then, my initial shock had worn off. I was sure that I would survive.

I didnt just survive, I live a full life. An active life. Cancer didnt stop, and I didnt allow cancer to disrupt. It was a bump on the road. Im cruising again. But the doctors words continue to reverberate in my ears. So Im always looking over my shoulder.

Over the last decade, major advancements have been made towards turning cancers into more treatable, easily detectable conditions.

Dr Humaid Al Shamsi, president of Emirates Oncology Society, offered his take on the game changers that are available today, and those that are shaping up.

Precision medicine:

In the simplest of terms, a blood test is used to assess a patients DNA. The analysis of tumour fragments gives clues on specific mutations that can be targeted during therapy.

Essentially, mutations are like locks on cancer cells, and the targeted therapy, administered intravenously or in the form of pills, acts like keys to those locks. This means that two patients with the same cancer could receive different therapies to target their specific cancers. The targeted therapy acts to stop the growth of the specific cancer tissue. In fact, a treatment that targets a specific mutation or genetic feature could be used to target vastly different cancer types, and the United States Food and Drug Administration has already approved treatments that act on specific cancer biomarkers rather than the site where the cancer originates.

Why this is a game changer: Targeted therapies are more effective at fighting the cancer when a patient responds to them. There are also potentially fewer side effects, and less harm to normal cells.

This aims to activate the bodys immune response, which is often put to sleep by cancer tissues.

Cancer cells grow by persuading the patients immune system that they are friendly, and eventually make this immune response dormant so that the cancer can grow. A PDL1 test, which looks for the PDL1 protein on cancer cells is usually carried out. This protein helps the immune system recognise non-harmful cells in the body, and cancers that have high amounts of PDL1 can therefore trick the human body and prevent the launch of an immune response.

More here:
World Cancer Day: Survivors in the UAE share their journey of fighting the disease - Gulf News

Global ovarian cancer drug marketis rise gradually to an estimated value of USD 5.6 Billion by 2026 substantial CAGR of 20.1% in the forecast period of 2019-2026. Rising incidence of ovarian cancer, growing geriatric population, and robust drug pipeline for treating ovarian cancer are the key factors for enhancing the market growth.

The winning Ovarian Cancer Drug business report offers a platform for marketing and business managers to obtain critical information about their consumers so that existing customers can be retained and new ones can be got onboard. The market research report helps in understanding customer inclination towards purchasing products. It also gives the details regarding whether the customers will spend a certain amount of money for their products, inclination levels among customers about upcoming features or products, what are their thoughts about the competitor products etc. Market data collected while generating Ovarian Cancer Drug market report is instrumental in making major changes in the business which reduces the degree of risks involved in taking important business decisions.

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Few of the major competitors currently working in the ovarian cancer market areAllergan Plc, AstraZeneca, F. Hoffmann-La Roche Ltd, Pfizer Inc., Merck KGaA, Syndax, Clovis Oncology, Boehringer Ingelheim International GmbH, GlaxoSmithKline plc, Exelixis, Inc., DelMar Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Novartis AG, Johnson & Johnson Services, Inc., AbbVie Inc., Oasmia Pharmaceutical AB, TESARO, Inc., Amgen, Inc., and among others.

Market Drivers

Market Restraints

Key Developments in the Market:

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Segmentation: Global Ovarian Cancer Drug Market

By Type

By Drug Type

By Treatment

By Route Of Administration

By End Users

By Geography

For More Insights Get Detailed TOC https://www.databridgemarketresearch.com/toc/?dbmr=global-ovarian-cancer-drug-market

Key Insights in the report:

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Global Ovarian Cancer Drug Market Size, Revenue and Growth Rate Through 2026||Pfizer Inc., Merck KGaA, Syndax, Clovis Oncology, Boehringer Ingelheim...

Introduction

Binge eating disorder (BED) is the most prevalent eating disorder (ED), with estimates of 25% of the general adult population, although its recognition as a single diagnosis only occurred in 2013 by the Diagnostic and Statistical Manual of Mental Disorders (DSM), fourth edition. In its latest edition, BED is defined by recurrent episodes of eating unusually large amounts of food while experiencing a feeling of losing control in the absence of regular use of inappropriate compensatory behavior. Marked distress regarding binge eating is present and the binge episodes occur, on average, at least 1 day a week for 3 months.1

Lifetime prevalence of BED ranged from 1.2% to 4.5% (when included subthreshold BED) and was noted to be more similar between men and women when compared to the distribution as observed with anorexia and bulimia nervosa.2 Typically, its symptoms begin during childhood and adolescence, but it can also be seen in the elderly with longer duration of illness reported.2 A previous study has shown a 12-month persistence of 44.2%, meaning that half of the patients could have achieved spontaneous remission on the course of the disorder.3 However, it can also assume an intermittent behavior.

Medical and psychiatric comorbidities are commonly observed in individuals with BED. At least one core DSM-5 disorder can be found co-occurring in up to 80% of BED patients, mainly depression and anxiety disorders, although other psychiatric disorders, including bipolar disorder, borderline personality disorder, and substance abuse have also been found to be related to BED.4,5 However, its association to general psychopathology, the presence of clinical comorbidity must not be forgotten. Higher prevalence rates of BED are found in overweight and obese individuals,6 and indeed, the presence of psychopathology as associated to obesity seems to be more severe in the presence of BED.7 Also, individuals with BED have an increased risk to develop type 2 diabetes, are more likely to develop nonalcoholic fatty liver disease, gastrointestinal problems, and disrupted sleep. An even higher prevalence was noted among infertile women.8,9

Previous studies have found impaired quality of life (QL) in individuals with BED. In addition, obese individuals with BED have shown reduction in QL when compared to non-obese BED patients. For instance, when using the Medical Outcomes Short Form-36 Health Survey (SF-36) to estimate QL, obese BED patients showed lower scores in comparison to the non-obese BED sample (45.3 [9.6] vs 53.6 [9.4], respectively, P = 0.001).10 Interestingly, obesity seemed to impact more on the physical variables of QL while BED was linked with poorer mental health and social functioning. Particularly, both the presence of depressive symptoms and a poor body image attitude seemed to objectively impact BED-QL.11

Despite its high prevalence rate and common association to clinical and other psychiatric problems, BED patients commonly remain either undiagnosed or receive inadequate treatment.12 Frequently, BED patients are referred to treat medical comorbidities without specialized eating disorder (ED) treatment.13 Considered underestimated in comparison to other frequently psychiatric complaints, such as depressive and anxiety-related symptoms which may culminate into inadequate psychological or pharmacological treatment choices.

Before considering BED treatment, an extensive evaluation should be made in order to identify and estimate problems in the 3 main areas of concern, namely, eating-behavior and related psychopathology, general psychological and psychiatric disorders, and presence of obesity with other medical problems possibly associated with BED.14 As a result, treatment algorithms should reflect the hierarchy and severity of problems in each individual area and should include the choice of different strategies that may include nutritional, psychological and pharmacological treatments. The American Psychiatric Association recommends a multidisciplinary approach that includes psychological treatment as a main approach and considerations for medication as adjunctive therapy.15 In contrast, the National Institute and Care Excellence also includes the possibility of medication monotherapy.16 However, both guidelines do not clarify which specific best practices of weight management should be offered, including dieting-based approaches, medication or even bariatric surgery.

A recent meta-analysis concluded that among BED adults, there is strong evidence that favors the use of cognitive-behavior therapy (CBT) and medications that include lisdexamfetamine (LDX), second-generation antidepressants, sibutramine (discontinued in many countries mainly due to cardiovascular risk) and topiramate. However, several limitations were found, which included methodological issues, fewer reports of adverse effects and discontinuation of drug trials, and the heterogeneity of outcomes.17 In this last regard, an optimal treatment related to eating, general psychopathology, and obesity severity is still required for a subset of patients.

Considering the lack of evidence on sufficient drug efficacy and the urge for new approved treatment options, this paper aimed to update recent pharmacological treatment data for BED by using the last 5 years as a timeframe. Reviews including interventions with previous timeframes had already been published and showed benefits of pharmacological treatment for BED. For instance, a previous meta-analysis that included 33 placebo-controlled trials showed a significant advantage of the pharmacological treatment over placebo for achieving short-term remission from BED (48.7% vs 28.5%).18 Despite that, only one agent emerged as an approved drug for BED treatment. Since 2015, when LDX received approval from the US Food and Drug Administration (FDA) for moderate/severe BED treatment in adults, no other medications have been approved and, in general, they have solely been used in an off label fashion. It is important to take into consideration the adverse effects that often lead to discontinuation: dry mouth, decreased appetite, insomnia and headache.

Pharmacological BED treatment in clinical practice usually follows hierarchic principles related to the patients complaints, the physicians evaluation and findings in physical examination or laboratory. Evaluation on each potential drug treatment for BED should be done taking into account clinical and psychiatric aspects, that may argue against the use of specific agents. Considering the importance to explore recent data on pharmacological trials on BED (including those that investigated new promising agents in order to point out to the best options available and future directions to remission achievement), this review was performed and condensed in Table 1. To enrich our findings, we also included sections related to novelty treatments for BED based on animal studies and advantages of each medication regarding adverse events.

In order to allow for a better understanding of the drugs role in BED, some neuromechanisms associated to a possible development and maintenance are exposed. In fact, many neurotransmitters, hormones and agents seem to be involved in BED induction and maintenance of BED. Below are listed some of the most significant findings related to this topic.

When BED is evaluated in the light of impulsive/compulsive food consumption theory, and its regulation by the brain rewards system hypotheses, dopaminergic neurotransmission seems the most appealing neuropathway to explore.19 In this model, the dopaminergic release, possibly due to an altered function in cortical and striatal regions, would otherwise be associated to motivational and control aspects of feeding (i.e., impulsivity/compulsive behaviors).19

Following a different neuropsychological path in accordance by many authors, the neurotransmitter serotonin (5-hydroxytryptamine [5-HT]), would be considered to have a key role in ED development. To support this hypothesis, studies show that serotonin is derived exclusively from dietary tryptophan, an essential amino acid. In excessive dieting and food restriction, a significant reduced ratio of tryptophan is found (mostly in anorexic patients). Furthermore, alterations on serotonin are associated to perfectionism and mood regulation. In a small study with obese binge eaters and non-obese binge eaters, decreased 5H-T transporter binding in the midbrain was found in the first group but not in the second.20

An agent with these properties, vortioxetine, was also tested for BED treatment. This substance is a serotonin stimulator which also increases noradrenaline, dopamine, and acetylcholine in certain areas of the brain, as well as modulating -aminobutyric acid and glutamate neurotransmission.21 More details of this study will be discussed later in this article.

Glucagon-like peptide-1 (GLP-1) is a hormone secreted from the small intestine in response to food ingestion. It can regulate food intake by slowing gastric emptying and through appetite inhibition in the brain thus reducing activation in appetite-related brain regions (possible brain areas involved: vagus nerve, nodose ganglia, hypothalamic nuclei, and the brain stem). Liraglutide, a GLP-1 receptor agonist, has been recently also approved for obesity management as an adjunct to physical activity and diet recommendations. It was previously approved in the type-2 diabetes treatment due to its effects associated with releasing insulin from the pancreas and decreasing glucagon release. 22

Oxytocin, another important hormone receiving attention in the last years, seems to play a strong effect on food consumption. Besides its anxiolytic properties and cortisol reactivity towards food,23 oxytocin appears to be also implicated in regulating reward-driven eating. This last hypothesis would be linked by the down-regulation of neural circuits related to the addictive theory of BED and bulimia nervosa.24

The two following agents, LDX and dasotraline used for ADHD treatment, were also tested for BED due to their co-occurrence, high levels of impulsivity in BED and growing findings, therefore suggesting that binge eating is associated with the dysfunction of dopamine and/or norepinephrine neurotransmission.19

Abbreviated from l-lysine-dextroamphetamine, LDX is a novel prodrug of dextroamphetamine (d-amphetamine) linked to the amino acid l-lysine, itself inactive and metabolized by mechanisms associated with red blood cells. With LDX hydrolysis, there is an inhibition of the reuptake of dopamine and norepinephrine from the synaptic cleft which simultaneously enhances the release of both, besides serotonin.25

Additionally, there is dasotraline, a novel dual-acting dopamine and norepinephrine re-uptake inhibitor which is the only drug being currently tested in trials for BED treatment. Following developments with LDX, methylphenidate is another psychostimulant used for ADHD and presumed to exert its effects by means of dopamine transporter blockage and is overall well tolerated by patients with low levels of treatment attrition.26 At last, although not a psychostimulant per se, we present a study with BED and armodafinil. This agent presents waking-promotion actions similar to the agents cited above and has psychoactive and euphoric effects. It is an indirect dopamine receptor agonist.

The use of agents such as naltrexone for BED is based on the model of an association between eating behavior and substance abuse. Considering that opioid system dysregulation underlies addictive binge eating, blockade of opioid receptors would diminish food intake and food craving thus being a form of anticipatory reward regulated by endogenous opioid and mesolimbic dopaminergic systems.27

Carbamates (disulfiram) act by inhibiting aldehyde dehydrogenase and as an alcohol deterrent, altering the intermediary metabolism of alcohol. This substance produces a sensitivity to alcohol, therefore when alcohol is ingested, blood acetaldehyde concentrations are increased, leading to: flushing, systemic vasodilation, respiratory difficulties, nausea, hypotension, and other symptoms.28 Certain BED features resemble those of alcohol users, such as the urge to consume (food/alcohol) and the lack of control over their consumption.29

Antiepileptic agents, specifically topiramate, due to its modulatory effects on GABAa receptors (involved in calory intake) contribute to an improvement in eating behavior and weight loss. Sympathomimetic amine (in this case, the agent phentermine) is associated with a decrease in appetite reduction and food consumption mostly for its action in releasing norepinephrine in the hypothalamus. The two are approved for obesity treatment by the FDA. The combination of both phentermine-topiramate involves the coadministration of drugs with opposing side-effect profiles. Phentermine stimulant-like properties may reduce topiramate sedative and cognitive side effects.30

Table 1 summarizes all results.

This drug is a dual dopamine and norepinephrine reuptake inhibitor and had been initially developed for attention deficit disorder (ADHD) treatment and Phase 3 trials had already been published. Its advantage, when compared to other stimulants or non-stimulant drugs used to treat ADHD, is its slow absorption rate and long elimination half-life which could diminish the potential for abuse and eliminate the problem of multiple dosing.

Three studies from the same pharmaceutic company, Sunovion, were performed for BED. The first one was a randomized 12-week treatment with placebo at a flexible dose (4, 6, 8 mg/day) with 317 patients. Significant reduction in binge eating was found starting from 6mg/d (3.74 vs 2.75; P<0.0001) and the drug presented good tolerability after 1-year follow-up.32 The second study investigated the impact of dasotraline on weight in this very same cohort of patients in a 3-month trial. Weight changes were observed at week 12 for completers treated with dasotraline vs Placebo and evaluated by the body mass index (BMI) categories: normal weight (4.6 vs 0.2), overweight (5.8 vs +1.3), and combined obesity classes IIII (6.2 vs +0.3).33

In the third trial, a different sample of 486 participants with BED were selected and randomized to a placebo, dasotraline 4 mg/day, or dasotraline 6 mg/day. Dasotraline 6 mg/day, but not 4 mg/day, was superior to placebo for reducing binge eating episode days (3.5 vs 2.9; P=0.004). Both doses produced significant reductions in obsessive-compulsive features of binge eating (P<0.001 and P<0.02) and global BED severity (P<0.01 and P<0.03). The drug was well tolerated in both studies, with the most common side effects being decreased appetite, dry mouth, anxiety, nausea, headache, constipation, and a modest increase in both pulse and blood pressure.34 On July 30, 2019, Sunovion announced the acceptance by the US FDA of the New Drug Application for dasotraline for the treatment of adults with moderate-to-severe BED. However, on May 13, 2020, Sunovion withdrew the application, citing that further clinical studies would be necessary to support regulatory approval. It should be noted that, previously, on August 31, 2018, the FDA had issued a letter determining that the drug could not be approved for the treatment of ADHD without additional data.

Commercially known as Vyvanse, LDX was primarily developed as a treatment for ADHD tailored to increase attention span and decrease restlessness. This is an inactive prodrug derived from amphetamine by means of a unique mechanism involving an enzymatic process predominantly associated with the red blood cells. It was developed with the aim of providing a long-lasting and consistent effect throughout the day along with reducing the potential for abuse.35

Since 2015, a robust development program carried by the same research group composed by 3 short-term trials: one dose-finding Phase II study, two dose-optimization Phase III studies,36,37 and two long-term trials, were performed in order to investigate its safety and efficacy in BED treatment.38,39

In the first study, a 11-week fixed-dose, parallel-group multicenter trial, with 259 adults across 30 sites in the USA diagnosed with BED and BMI between 25 and 40 kg/m, were randomized to receive LDX 30, 50, 70 mg/day or placebo. Seventy-eight percent of subjects completed the double-blind phase of the study. Binge eating episodes significantly decreased in the 50 and 70 mg/day treatment groups, but not in the 30 mg/day treatment group as compared to the placebo group. Specifically, in the LDX 50 mg/day group, binge days/week decreased from 4.5 to 0.4 (P0.008) and in the LDX 70 mg/day group binge days/week decreased from 4.6 to 0.5 (P0.001).36

With the same participants sample, two subsequent trials used an enrichment strategy according to the following scheme: 1) 12-week open-label phase (dose optimization: 4 weeks of 50 or 70 mg); 2) dose maintenance of 8 weeks; 3) a 26-week, double-blind, randomized withdrawal phase; and 4) a follow-up visit. LDX was superior to placebo for reducing binge eating day frequency, global BED severity, and obsessive-compulsive features of binge eating. Significantly more LDX recipients had cessation of binge eating in both studies (36.2% and 40%) compared to placebo (13.1% and 14.1%, p < 0.001) and more significant body weight loss. In regards to the safety profile, adverse reaction rates beyond 50% were not higher than those found with other psychotropic agents and were equally distributed across both active drug and placebo groups. In addition, both studies did not show elevated discontinuation rates due to adverse effects (6.3% and 3.9%). Also, although weight loss was not a primary endpoint, it was comparable to what have been found in trials with anti-obesity agents, ranging between 5 and 12 kg for the 12-week open-label phase. Finally, and not to be disregarded, there was some evidence that LDX has a low potential risk of abuse.36,37,40

The randomized withdrawal maintenance of efficacy study38 examined rates of binge eating relapse in LDX treatment responders following 12 weeks of open-label treatment. The risk of binge eating relapse over a 6-month period was significantly lower in participants randomized to continuing LDX than in those randomized to placebo. The long-term safety and tolerability study consisted of a 1-year open-label extension trial of LDX in BED participants who had completed one of the three short-term trials. A mean (SD) of 7.04 (7.53) kg in weight reduction was reported at the end of the study.39

LDX was the first medication to receive regulatory approval for the treatment of BED in the world (2015). It is specifically approved for moderate and severe BED in adults at 5070 mg/day. The recommended starting dose in BED treatment is 30 mg/day with increments of 20 mg/day to achieve the recommended target dose of 50 to 70 mg/day.31

Due to the strong association between dopamine and eating behavior, methylphenidate was selected to a randomized comparison with CBT in order to improve BED symptoms. Twenty two patients took a flexible-dosage ranging from 18 mg/d - 72 mg/d by the end of the fourth week and 27 patients completed the psychological treatment composed by 12 sessions. Both groups presented binge-free patients: 47% for medication and 60% for CBT, 2 = 0.62, p = 0.43; subjective binge episode remission: 41% for medication and 35% for CBT, 2 = 0.15, p = 0.70. As to weight loss, a significant difference in BMI was found at Week 12 compared to Week 0 for the methylphenidate group= 5.18, p < 0.001, but not for the CBT group= 1.54, p = 0.13. Despite the drug potential, the study hardly mentioned the side effects.41

A 10-week, randomized placebo-controlled trial was conducted with 30 BED patients for placebo and 30 BED patients for the armodafinil group (150250 mg/d) neither with a current history of anorexia or bulimia nervosa. In the first analysis, there were no significant differences between the groups in reducing binge-eating day frequency. Armodafinil was associated to a greater reduction in binge eating frequency, BMI and obsessive symptoms.42

The effects of oxytocin on food intake, 24-h caloric consumption, salivary cortisol, and stress were measured in a randomized, placebo-controlled, crossover laboratory study in 25 women with BN or BED and 27 weight-matched women without a history of eating disorders. Participants attended the lab for two experimental sessions, received a divided dose of 64IU of intranasal oxytocin in one session and an equivalent volume of a placebo nasal spray in the other. There were no significant effects of oxytocin on any measurements.24

Naltrexone extended-release + bupropion ER combination (NB) is an anti-obesity agent approved in the USA as an auxiliary component to dieting and physical activity for chronic weight management. Their combination was developed based on pre-clinical evidence that this association has complementary effects in the reduction of food intake. The first component is an opioid antagonist that has a high affinity for the -opioid receptor which is related to eating behavior.43 The second one is an antidepressant (norepinephrinedopamine reuptake inhibitor) that has shown efficacy in smoking remission and on weight loss. However, the use of bupropion alone did not improve binge eating behavior in a previous randomized trial.44 Interestingly, in a small retrospective cohort study, bupropion was effective in reducing binge frequency and, when compared to sertraline, achieved greater weight loss and improved sexual performance.

An open-label prospective study of 24 weeks was performed in 2017. The authors evaluated the NB combination therapy (32 mg/day of naltrexone ER and 360 mg/day bupropion ER) associated to diet and physical activity guidance in 25 overweight/obese subjects with depression. Medication was initiated at one-quarter of the daily maintenance dose and raised over the first 4 weeks of treatment. The binge eating scale (BES) scores were improved and maintained during the trial and, by week 8, there were no more patients that fulfilled the criteria for severe BDE. Overall, BED symptoms and weight loss improved.45 An important limitation of the study was that 12 patients dropped out before week 24 (n=10 due to adverse events). Forty-eight percent of the patients considered these adverse effects moderate, mostly consisting of constipation (n = 8; 32%), headache (n = 8; 32%), insomnia (n = 8; 32%), dizziness (n = 7; 28%), and hot flushes (n = 7; 28%).

In 2020, a 16-week open label-trial, with 23 patients with obesity and BED and a control group of 20 obese non-BED patients, was concluded. All patients should have undergone at least five weight-loss programs without success. NB of prolonged-release containing 8 mg of naltrexone and 90 mg of bupropion was initiated and slowly increased from 1 tablet a day up to a maximum of 2 tablets twice a day after the third week and followed by another 13 weeks maintenance phase. In parallel to NB, a 16-week lifestyle program, consisted of hypo-caloric diet, behavioral counseling and moderate aerobic physical activity was also implemented. Binge eating behavior weight loss improved in BED patients (p=0.003). By the end of the treatment, achieved BMI was statistically similar between both groups (BED group = 35.8 6.8 vs Control group = 40.3 8.8; t = 1.687; p = 0.101).46

The premise for vortioxetine use in BED was based on the fact that a varied circuitries appear to be involved in BED physiopathology.47,48 Thus, a multi-modal target medication, such as vortioxetine, could be helpful. Also, it appears to have a cognitive enhancing potential which may be useful in disorders that display an impaired executive control.49 For at least a year, eighty adults with BED were recruited for a double-blind, placebo-controlled pilot study. Participants received a 12-week treatment with vortioxetine (10mg/day for the first week and subsequently 20mg/day) or placebo in a parallel design. Binge eating frequency was noted to be significantly reduced over time in both groups. Weight and BMI did not change over time (p>0.10). Thus, vortioxetine failed to be more effective than placebo for BED treatment. (NCT02528409)

GLP-1 was developed as a type 2 diabetes management; however, it is also used as an anti-obesity drug and sold in the form of a once-daily injection with effects known to inhibit appetite and delay gastric emptying in non-diabetic obese participants with BED symptoms.

In a small randomized pilot study, 44 obese binge eaters were assigned to either a liraglutide 1.8mg + diet and exercise group or a control (diet + exercise) group for 12 weeks. Liraglutide participants showed significant reductions in BES [20 (IQR 1827) to 11 (IQR 716), p < 0.001] and 81% (n=17/21) of them experienced a change in status from a binge eating to a non-binge eating category. Other measures were also improved such as body weight (94.5418.14kg to 90.1419.70kg, p<0.001) and BMI (36.15 3.84 kg/m2 to 34.40 4.77 kg/m2, p<0.001). Nausea was the most prevalent adverse symptom.50

In 2017, the binge eating liraglutide intervention study (BELIEVE) was initiated. A 17-week, randomized placebo-controlled trial tested the efficacy of liraglutide 3.0 mg/d compared to placebo in achieving remission of binge eating episodes and other clinical variables. The active comparator was a pre-filled, multi-dose pen that delivered doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injections. The medication was initiated at 0.6 mg daily for 1 week and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day was achieved. However, the study was terminated due to not meeting its recruitment goals.51 (NCT03279731)

In a 16-week study, doses of disulfiram 250mg/day were given to twelve obese patients with BED and without a history of alcoholism and heart disease. The agent significantly decreased the mean frequency of binge eating episodes per week from 7.9 1.2 to 0.9 0.6 (p b 0.001) and 7 participants (58.3%) achieved remission of binge eating. No changes in weight were observed and 11 participants presented important side effects. Additionally, three participants dropped out during the study, remaining a total of 9.52

Two previous open-label studies and one placebo-controlled trial had shown improvement in appetite and weight loss in obese BED patients.53 However, more controlled-trials aimed to establish optimal dosing and length of treatment were not performed. Also, cognitive impairment and somnolence were some of the most frequent adverse events that interfered with the patients' tolerability. The phentermine-topiramate (PHEN-TOP) combination was approved by FDA in 2012 for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity. The investigation of PHEN-TOP in BED treatment was based on a suggested evidence, in contrast to previous topiramate studies, that by lowering doses of topiramate in this combination it would be potentially effective in reducing binge eating behavior thus being safer and more tolerable. The potential role for this drug association in BED treatment was that, in the present study, 18 participants with BED and 4 with BN over 18 years of age were enrolled in a flexible dosage (3.75mg/23mg-15mg/92mg) placebo-controlled crossover trial of 34 weeks.54

LDX, despite FDA approval for BED treatment, definitely presents some significant pros and cons; Table 1 shows details of every study efficacy. The amphetaminic risk of abuse and dependence requires a careful evaluation before prescription. The safety profile is consistent with what was seen in studies using LDX in adults with ADHD; the most common adverse events in the adequate dose of 5070 mg/d are: dry mouth (52%), decreased appetite (25%) and insomnia (19%) and 1.5% has serious adverse effects. The treatment group demonstrates efficacy compared to the placebo group in terms of decrease in BE days and cessation, and global improvement.36

Overall, the second substance mostly investigated was dasotraline. Due to the smaller risk of abuse and dependence, compared to LDX, its development program was very encouraged, showing significant results with 68 mg/d on BE episodes vs placebo (3.5 vs 2.9; P=0.0045). The most common adverse events on dasotraline were: insomnia, dry mouth, headache, decreased appetite, nausea, and anxiety.34 Despite the results, the laboratory withdraw the substance for BED treatment due to the need of further regulatory approval.

In the liraglutide study, forty-four obese BE participants were randomly assigned to intervention or control groups for 12 weeks. All participants received standard advice for diet and exercise. 81% (n=17/21) of those receiving liraglutide improved from binge eating to non-binge eating category, and 2 patients developed nausea. These results are still very scarce. In our opinion, sometimes the non-friendly presentation (injection pen) and the prevalence of nausea as the most common adverse effect are some weak points of the substance use.50

The combination naltrexone-bupropion (already approved for obesity treatment in 2014), despite small groups of patients, was well succeeded for diminishing BE severity and scores, as well as weight loss (89%). The most common side effects had very high rates: nausea (67%) and anxiety (22%), what may impair a sensitive group of patients to proceed. Another combination: phentermine-topiramate was evaluated in two small studies with favorable results, especially on weight loss (average of 6%). The most reported symptoms were: 52.4% (dry mouth), insomnia and paresthesia (28%).

Agents tested in few studies or small samples, such as armodafinil, oxytocin and vortioxetine despite being well tolerated, and presenting some impact of BE and weight, did not present significant differences when compared to the control group. Findings in a methylphenidate and CBT study showed that both interventions were effective in BE measures, with a higher effect of the agent on weight loss (week 0 to week 12 = 5.18, p < 0.001).

Some experimental drugs have been successfully tested in validated animal models of binge-like eating and could represent future investigations in clinical studies:

Corticotropin releasing factor (CRF) represents a hormonal marker of BE induced by cyclic food restrictions and stress and may represent a novel pharmacological treatment for binge-related eating disorders. Indeed, systemic injections of R121919, but not of the metyrapone, were able to block binge-like eating behavior in female rats.55

Sig-1R system seems to contribute to the neurobiological adaptations driving compulsive-like eating, and thus pointing towards pharmacological treating of BED. The authors proved that the treatment with the selective Sig-1R antagonist BD-1063 dose-dependently decreased food responding in binge eating rats.56

Brain orexin 1 receptors (OX1Rs) are involved in food-motivated behavior. A study investigated the ability of OXR antagonist to block BE episodes and to evaluate the involvement of OX1 and OX2 mechanisms in the control of BE episodes in restricted and stressed animals. The results clearly indicate that the OX1R is involved in the control of BE episodes and suggested a potential role of OX1R antagonists to reverse BE episodes induced by stress and restricted diet.57 Other results with rats also suggest that hindbrain OX1Rs play a role in motivation for palatable food and that hindbrain OX1R stimulation can increase palatable, energy-dense food intake.58

Authors examined the effect of two A(2A) adenosine receptor (AR) agonists, CGS 21,680 and VT 7, on high-palatability food (HPF) intake in a model of BE in sated rats and on low-palatability food (LPF) intake in food-deprived rats. BE was induced in female rats by three 8-day cycles of food restriction/refeeding, followed by acute stress. The present study confirmed that the combination of stress and repeated episodes of food restriction is able to induce a pronounced binge eating response for HPF in rats.59

Since its categorization as an ED diagnosis in 2013, various studies have been published that investigated the effectiveness of different pharmacological treatments. Yet, up until now, the only drug approved by the FDA for BED treatment is LDX, which is not necessarily fit for all individuals with BED. Actually, in a real-life scenario, BED treatment could follow a variety of different algorithms and, in everyday practice, different off-label drugs are notably used as first-line agents.

Since 2015, only two antidepressant drug-trials have their efficacy in BED treatment investigated. In contrast to a previous study, which did not show improvement in binge eating behavior with bupropion treatment alone, NB treatment has been associated with BED improvement and some weight loss. According to previous evidence, it seems that for BED patients presenting with mood-related psychopathology, bupropion use might improve eating psychopathology as well. However, obese BED patients who did not present with clinically depressive symptoms would benefit more from NB treatment. Nevertheless, it should be noted that NB has been studied in small open-label trials and more extensive studies should still be performed. The second antidepressant investigated in BED treatment was vortioxetine. In spite of a lack of previous clinical evidence, findings showed that this drug has a limited efficacy of second-generation antidepressants when used alone in BED.

The next new promising agent, dasotraline, was chosen and is still expecting FDA approval. Overall, results from 2 double-blind studies, published by the same pharmaceutical industry, were favorable to its use in the reduction of BED episodes and reduction on obsessive traits related to eating behavior. In one of those investigations, dasotraline was also related to some modest weight loss. Nevertheless, the discontinuation of the dasotraline program diminished the chance to have a second FDA approved agent for the treatment of BED in the near future. In this regard, a similar discussion could be made in relation to the use of liraglutide for the treatment of BED. Though only a pilot open-label study has been demonstrated for its benefits in reducing eating psychopathology in a small sample of obese patients with high binge eating scale scores not formally diagnosed as BED and with an evident impact on weight reduction and safety profile much expectation was given towards further studies. However, termination of its double-blind randomized trial also temporally puts away the chance of having liraglutide approved for BED. Of note, in clinical practice however, a significant percentage of patients that have been treated for obesity with liraglutide might have also been treated for BED, even if not clinically diagnosed, due to the higher prevalence of their comorbidity.

Considering the lack of evidence of armodafinil and oxytocin, the modest effect of disulfiram in an open trial and a favorable result of methylphenidate in a small randomized trial, the next drug awaiting for promising results in the treatment of BED might be the PHEN-TOP combination. Although only 2 small studies investigated its use for BED, some considerations might be worthy taking into account. Firstly, topiramate alone had previously showed to be effective in BED trials. Secondly, the premise to use a drug combination that allows smaller doses of topiramate to be tested increases its safety. Indeed, this can be evidenced in face of the PHEN-TOP approval for adjunct treatment of obesity in 2012. Lastly, the inclusion of patients with bulimia nervosa in one of the studies might shed some light on a future new drug for another ED.

The last 5 years have shown how difficult it is to prove sufficient efficacy and safety for new drugs in BED treatment. Since 2015, LDX has remained the only drug treatment option approved by the FDA. Interestingly, most studies of investigational drugs in this period were performed with agents that had already shown a positive impact on previous eating-related psychopathologies (though used in a different fashion as in naltrexone added on bupropion and phentermine added on topiramate) or had been known for its efficacy on obesity (liraglutide). However, much effort still needs to be employed as new studies are urgently needed especially given the negative impact of BED on QL and clinical morbidity. Meanwhile, guidelines for BED treatment, particularly those targeting non-psychiatrists, should be considered towards a recommendation on the use of off-label agents and the need for individualizing drug treatment choices in accordance to clinical and psychiatric status.

Jose C Appolinario reports grants from Takeda Pharmaceutical, during the conduct of the study. The authors report no other potential conflicts of interest for this work.

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[Full text] Binge Eating Disorder: A 5-Year Retrospective Study on Experimental Dr | JEP - Dove Medical Press

Ian Richardson|Des Moines Register

What will the Iowa Legislature focus on in 2021?

Iowa's legislators discuss some of the topics they plan to address in the 2021 session.

Des Moines Register, Des Moines Register

Iowa House Republicans advanced a bill Tuesday that would require physicians to provide women seeking medication-induced abortions informationabout reversing thepillseffectsinformation that critics say isunproven and scientifically disputed.

The bill,House File 53, would require doctors to provide patients with information of the risks associated with a medication-induced abortion and notify them"that it may be possible to reverse the intended effects of a medication abortion if the woman changes her mind," but "that time is of the essence."

Republicans and anti-abortion groups said the measure would provide full disclosure to women who may regret taking the first doseofabortion-inducing drugs. But Democrats and abortion rights advocates said Tuesday thelegislation would push doctors to provide their patients with unsoundinformation.

After working for several years on pro-life legislation, I have heard and read the testimonies of hundreds of women who had deep regrets of their abortion, Rep. Shannon Lundgren, R-Peosta, said in an email. Many women make this decision because they believe it is the only option they have. Informing a woman that it can be reversed should be part of that discussion to prevent the pain and suffering that many women may have by making that initial choice.

The bill would require facilities that perform medication-induced abortions to "conspicuously post a sign" relating to the possibility of "avoiding, ceasing or even reversing" the effects.The bill wouldalso require the Iowa Department of Public Health to publish information about reversing the effects on its website.

"It is unethical and dangerous for politicians to require medical professionals to share inaccurate information to promote a political agenda," Jamie Burch Elliott, a lobbyist for Planned Parenthood Advocates of Iowa, said in a statement.

The measure would require doctors toprovidemedical discharge instructions that include a statement on the possibility of reversal.The state could enforce discipline against doctors who dont comply.

Instead of surgery, medication abortionsinvolve taking a combination of two drugs to terminatepregnancies. The drugs are commonly mifepristone,a pill thatblocksthehormoneprogesterone, and a second drug, misoprostol, that completes the abortion.The first dose of the drug comes a few hours or days ahead of the second,according to the Mayo Clinic.

Taken by itself, the first drugwill not always terminate the pregnancy, according to the American College of Obstetricians and Gynecologists. The group saysup to half of women who take only the first drug have continued their pregnancies.

Proponents ofmedication-induced abortionreversal contend thatafter taking thefirst drug, women can takeprogesterone to reverse the effects.

Daniel Sunne, a lobbyist for the conservative Christian organization the Family Leader, said Tuesday thataccording to the Abortion Pill Rescue Network, which isconnected tothe anti-abortion organization Heartbeat International, such reversal has saved more than 2,000 lives.

We believe more unborn children will be saved if Iowa passes this bill,Sunne said.

Kim Laube, director of life ministries at Lutheran Family Service, a Christian organization that provides pregnancy support and other services,pointed to a2018case series published in the journal "Issues in Law and Medicine"that observed 754 womenwho attempted to reverse the effect of the first abortion drug. The study declared thatreversal using progesteroneis "safe and effective."

But many medical experts have criticized the observational studyfor not following proper methodology, including not having a control group.

Dr. Lindsey Jenkins, legislative chair for the Iowa chapter of the American College of Obstetricians and Gynecologists, said in a statement that the claim is "based on limited studies that are scientifically weak and rely on an ethically compromised method."

A news release from Planned Parenthood Advocates of Iowa, which included Jenkins' comments, pointed to a 2019 study of abortion pill "reversal" from the journal "Obstetrics & Gynecology" that … ended early due to safety issues when some of the women who participated began hemorrhaging.

"By scripting physicians and compelling them to provide medically inaccurate information and steer patients toward untested procedures, this bill is in direct violation of a physicians oath to care," she said.

Rep. Beth Wessel-Kroeschell, D-Ames, who cast the sole dissenting vote on the bill during Tuesday's subcommittee meeting, said she sides with the medical group.

"I have a master's in public administration," she said. "I would never override what the obstetricians and gynecologists would tell us when it comes to care of a pregnancy."

Lundgrensaid according to the American Association for Pro-Life Obstetricians and Gynecologists, progesteronehas already shown its safe and effective through use in some high-risk pregnancies.

It is unconscionable that we would deny women information on a safe prescription that has proven to be especially effective by its use in stopping miscarriages, she said.

The three-member subcommittee advanced the bill on a 2-1 vote Monday. Thebillwill now head to the full House Human Services Committee.

If the bill becomes law, Iowa would joinsixstates with laws in effect that requiresimilarnotification Arkansas, Idaho, Kentucky, Nebraska, South Dakota and Utah accordingtothe Guttmacher Institute.Courts have temporarily enjoined related laws in three more states: North Dakota, Oklahoma and Tennessee.

Ian Richardson covers the Iowa Statehouse for the Des Moines Register. Reach him at irichardson@registermedia.com, at 515-284-8254, or on Twitter at @DMRIanR.

Read more:
Bill would require Iowa doctors to give information on medication abortion 'reversal'; critics call the information unsound - Burlington Hawk Eye

CARLSBAD, Calif., Jan. 26, 2021 /PRNewswire/ --Qualigen Therapeutics, Inc. (Nasdaq: QLGN),a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announces achievement of a milestone event which triggered a payment obligation from Yi Xin Zhen Duan Jishu (Suzhou) Ltd. of Suzhou, China (Yi Xin) to Qualigen. The milestone event pertained to the initiation of technology transfer of Qualigen's core FastPack System, a rapid and highly accurate immunoassay testing system consisting of the FastPack Analyzer and the FastPack single-use, disposable test pouch.

Under the terms of an agreement announced in October 2020, Yi Xin will develop, manufacture and sell new generations of diagnostic test systems based on Qualigen's core FastPack "laboratory in a pouch" technology, which includes high throughput diagnostic systems. In addition, Yi Xin will have the rights to manufacture and sell Qualigen's current generations of rapid point-of-care FastPack diagnostic products in China. The agreement called for net cash payments to Qualigen in the fourth quarter of calendar 2020 and the first quarter of calendar 2021 totaling in the mid- to high-hundreds of thousands of dollars, and Qualigen is also eligible to receive low- to mid-single-digit royalties on net sales.

"Yi Xin provides entre to the China market for our patented FastPack diagnostics product line and we are encouraged by the strong start to this alliance," stated Michael Poirier, Chairman, Chief Executive Officer and President of Qualigen. "This collaboration represents an expansion opportunity with additional resources to grow the FastPack line in an efficient manner while we advance our therapeutics pipeline focused on the treatment of cancer and viral-based diseases toward clinical trials this year."

"Accurate testing at the point of patient care is becoming increasingly important across China to achieve better patient outcomes and utilize healthcare resources more efficiently. We are looking forward to launch the current FastPack product and developing new generations of the FastPack system that include a high-volume system analyzer for use in large hospitals and reference laboratories," said Peng Zhou, President and Chief Executive Officer of Yi Xin.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for 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 nucleolin-targeting DNA aptamer of ALAN, AS1411, is also a drug candidate for use in treating COVID-19 and other viral-based infectious diseases. 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 Statements

This 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 expected payments to the Company under the Yi Xin agreement and Yi Xin's future development, manufacturing and sales activities. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that Yi Xin's future development, manufacturing and sales activities will proceed as anticipated or that Yi Xin (which is a newly-formed company) will be able to honor its contractual obligations to the Company; that clinical trials will be applied for by or approved to begin by any projected timeline or will proceed as contemplated by any projected timeline; 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 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 owned and 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, Inc.

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Qualigen Therapeutics Announces Completion of Milestone Related to the License and Technology Transfer of its FastPack Diagnostics Products in China -...

What's Clover Health's (NASDAQ:CLOV) key to success? Its technology. However, that key won't open any doors unless physicians and other healthcare professionals use the company's technology. In this Motley Fool Live video recorded on Nov. 16, 2020, Bill Mann, director of small cap research for The Motley Fool, talks with Clover Health co-founder and CEO Vivek Garipalli about how his company wins over healthcare providers to use its platform.

Bill Mann: Every single medical device company I've ever talked to, when they talk about the objections to getting broader adaptation, it hinges upon one thing. Well, is Mayo Clinic using it? Is Cleveland Clinic using it? Is Harvard using it? How do you go from a system in New Jersey to much broader adaptation? How do you get that customer adaptation in a fairly conservative audience?

Vivek Garipalli: Yes, interestingly enough, Clover Assistant, for the most part initially scaled in our New Jersey markets and then the 200,000 lives are bringing on to direct.

Bill Mann: That's not Mayo though.

Vivek Garipalli: Correct. Then the 200,000 lives that we're bringing on April next year, half of them are non-New Jersey and that these are physicians adopting Clover Assistant. Who were not familiar with Clover Assistant prior, so when you think about what primary care physicians care about versus interventional cardiologists, orthopedic surgeons, there's a huge body of data appropriately on device efficacy, I think it's some of what you're referencing.

Whether it is a certain implant or whatever it may be that relies heavily on, do you have the right orthopedic surgeons as part of your clinical trial advocating for the device or product, primary care. When we think about chronic conditions, which drives over 90 percent of costs and Medicare, and unfortunately, any one of us at some point in a life will probably end up with one or more chronic conditions. They range from diabetes, congestive heart failure, chronic obstructive pulmonary disease. These are conditions that are really around appropriate treatment or management of conditions while you have them.

A lot of the organizations you described are hospitals, they are managing your care once you've hit the emergency room and now you are an inpatient. The condition has exacerbated. You are now in need of a complex surgery, and a very specific type of surgery ensuring quality surgeon. When you think about hospital care, that's a narrow segment of care, very high a cost of it as well. When you think about managing primary care, that's really around presenting to physicians not Mayo protocols or not Mount Sinai protocols. It's actually presenting peer-reviewed, evidence-based protocols, and that is not necessarily tied to brand, is tied to evidence, it's tied it's already been published.

Even when we think about surfacing diagnoses -- when we're surfacing diagnoses it's tied to rules entrants. EGFR result between 30 and 60, which means that the particular patient may have chronic kidney disease, but Stage 3, asymptomatic. Only really denoted by a lab result, but at the same time that's how the literature lays it out. If that data point is not presented to a physician the point of care here, she's not going to diagnose that condition and it's going to end up progressing probably about a third of the time elicits elevated thyroid hormone levels and your bone breaks down and you fall in your break your hip.

That's healthcare today. That's where data paired with evidence presented to a physician where the physician can now make a better decision. We're not in the business nor will we ever be telling the position what to do or not to do, it's really presenting evidence to take that 10-20 minute visit and make it more valuable, whether it's assessing a condition that wouldn't have otherwise been assessed, presenting machine learning algorithms that will generate what a potential diagnosis may be without actually saying it does or doesn't exist, but just what are data's shows could be present and that prompts a conversation, that may or may not lead to a condition being captured.

But to your point of how the space looks at software and technology, when organizations are building technology for physicians within healthcare, it's almost as if they throw away the software playbook that has worked for successful companies outside of healthcare. If we take businesses like whether it's Amazon (NASDAQ:AMZN) or e-commerce company like that, they have to one, make sure that the data that they're presenting to consumers is trusted and can be relied upon.

Two, in terms of the product picture is accurate and their shipping time is accurate, two they need to make sure that payment construct's accurate. Is the price you are being told to pay actually the price, if you're saying it's ranked from low to high in prices that the truth is that how it plays out. Then in terms of features and consumer value, is that continuing to improve rapidly over time, but in healthcare, that's not how software is built. When we, when we thought about building great software, only one aspect was, we need to make sure this can add value to physicians and drive rapid feature development, that was key.

For the first part was we need to make sure that the data we're presenting to physicians can be relied upon, it's accurate it could be sourced, whether if it's evidenced-based protocol, that that could actually be brought up at the point-of-care in terms of what evidence are we citing over to lab result, where do we get that lab result? If it's based upon a claim that led to a chart that we pulled that had conditions on it which positioned to that come from, and then in terms of the payment side, our positions penalized for not agreeing with the Clover Assistant.

Are they rewarded for agreeing with the Clover Assistant? We don't do either of that. From our perspective is a physician went to medical school for four years, fellowship, residency, practice for many years, took the Hippocratic Oath, really cares about his or her patients. We believe, fundamentally, that if we pay physicians fairly and more obviously for now using additional piece of software, the point-of-care, and give them better and more accurate information, actionable data, and as Andrew described, a true real-time conversation, their decision-making is going to improve for the benefit of the patient, and we do not modularly payment up or down tied to what buttons they're clicking on in Clover Assistant, and just that very simple construct, that is not accepted philosophy in incumbents.

That you cannot get them to agree to pay physicians the same amount for using software irrespective of what they're clicking, irrespective of acuity, because there's an obsession in value-based care down to paying for everything that what agree with as a payer or penalize if we don't agree with it, and the intent is proper, but that is not how you build trust with physicians on the payment side.

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Here's Clover Health's Secret to Winning Over Healthcare Providers - The Motley Fool

Dr. Jacqueline Parchem, a maternal-fetal medicine physician at UTHealth in Houston, considers herself a private person. Even still, she logged on to Twitter on Dec. 22 and began drafting a series of posts.

Pregnant and unsure about the #COVID19 vaccine? she wrote in a tweet that has now been liked more than 3,000 times. Youre not alone. Got vaccinated today at 31 weeks [pregnant] and feel very fortunate. But its complicated.

Over the course of nine tweets, Parchem broke down the thinking that went into her difficult decision to get vaccinated during pregnancy. Ultimately, she wrote, she decided her substantial risk of being exposed to COVID-19 while caring for patients outweighed any hypothetical risks associated with the vaccinebut the choice wasnt easy.

There are virtually no data on how COVID-19 vaccines affect pregnant people and their fetuses, since vaccine makerslike many companies testing a new drugenrolled only non-pregnant adults in their clinical trials. Plus, the two vaccines authorized so far in the U.S., those made by Moderna and Pfizer-BioNTech, are the first widely available shots to use mRNA technology, so there is little frame of reference as to how they might affect pregnant people. Moderna reportedly found no safety concerns after testing its shot in rats prior to or during pregnancy, but animal data only reveal so much.

While the mRNA technology used in Pfizer-BioNTech and Modernas shots hasnt been tested on pregnant people, the U.S. Centers for Disease Control and Prevention (CDC) says they are unlikely to pose a significant risk for people who are pregnant. The vaccines do not contain live virus, which means they cannot infect the recipient with COVID-19, and they do not enter the part of the cell that holds DNA.

Still, without strong data, most U.S. health groups have essentially left the decision about whether to get vaccinated while pregnantor while breastfeeding or trying to get pregnantup to individuals. The CDC, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine (of which Parchem is a member) say pregnant people should not be excluded from vaccination if they are otherwise eligible to get their shots, but they do not explicitly make a recommendation one way or the other.

In the U.K., however, health authorities have specifically stated that those who are pregnant should not routinely have this vaccine, though people at particularly high risk of COVID-19 exposure may choose to get it.

That pregnant people in the U.S. havent been excluded from vaccination is great, but it doesnt answer the question, Should I get the vaccine? Parchem says.

Experts saw this dilemma coming. Even though millions of people in the U.S. alone give birth each year, pregnant people are frequently excluded from drug trials, in part due to understandable concerns about exposing unborn babies to potentially harmful substances. The legacies of drugs that were proven to be dangerous for pregnant people and their fetusesincluding the anti-nausea medication thalidomide and the synthetic hormone diethylstilbestrolafter approval still loom large.

Pregnant people have historically been considered a vulnerable populationa designation also applied to groups, such as children and the incarcerated, who may be coerced into participating in research. OB/GYN and author Dr. Jen Gunter says that label was never appropriate for pregnant people, who are more medically complex, for sure, but are perfectly capable of deciding whether or not to enroll in a study.

The medical community is increasingly moving away from using the vulnerable label for pregnant people, but pharmaceutical companies must still take certain precautions when designing study protocols that include expectant mothers. Many simply choose not toespecially in situations, like developing COVID-19 vaccines, where speed is crucial. One study found that, out of 468 drugs approved by the U.S. Food and Drug Administration from 1980 to 2000, more than 90% came with no conclusive information about their risk of birth defects.

As a maternal-fetal medicine specialist, helping pregnant people navigate this dearth of research was part of Parchems job even before the pandemic. Taking drugs often presents a moral quandary for pregnant people, she says, since medications are rarely tested for use among that population.

Naturally, people tend to center on the fetal risk, Parchem says. But she says its also important to consider the consequence of not getting this treatment for the mother. In the case of COVID-19, that could include severe illness or death. Pregnant people who get COVID-19 are at increased risk of requiring intensive care, studies show, and they may also be at risk of complications including preterm birth.

Faced with that calculus, many other pregnant health care workers have chosen to get vaccinated. Dr. Leslie Kim, a facial plastic surgeon at the Ohio State University Wexner Medical Center, in early January posted on Twitter and Instagram about her decision to get vaccinated at 32 weeks pregnant.

After speaking with her own doctor, Kim, who regularly performs procedures on or near patients airways, decided her risk of exposure to COVID-19 was high enough to justify getting vaccinated.

Kim also felt a responsibility to add, in however small a way, to the publics understanding of vaccination during pregnancy. For pregnant people to be included in studies, they do have to volunteer, Kim says. All of us who are stepping forward[are] contributing to the science of this vaccine. While formal studies on COVID-19 vaccines and pregnancy have not yet been completed, Kim says she hopes others in her position are diligently reporting side effects or anything we experience so we can help future people in our shoes.

For Dr. Denise Cardenal, an OB/GYN affiliated with OB Hospitalist Group in St. Lucie, Fla., the desire to protect her family and community from COVID-19 provided motivation not only to get vaccinated at 31 weeks pregnant, but also to post about the decision on Facebook. Im not one to share anything about what I do as a physician on Facebook, she says. But I saw this as such an important opportunity to set an example.

Already, she says, shes heard from people who have decided to get vaccinated because she did.

Still, Cardenal emphasizes that the decision is a personal one. Someone who can stay home throughout her pregnancy may want to wait to get vaccinated until after she gives birth, whereas someone with a higher exposure risk may not. Each individual should talk to their doctor and read up on health groups guidance before making a choice, she says.

People should question the data, the science, what is out there. You have to inform yourself, Cardenal says. Hearing from health care workers who have chosen to get vaccinated can be part of that.

Until there are published clinical trial results, the best information about COVID-19 vaccines and pregnancy may indeed come from people choosing to share their private decisions publicly. We dont want to make any decisions by a [sample size] of one, Gunter says, but people stepping up is really an amazing service.

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Write to Jamie Ducharme at jamie.ducharme@time.com.

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Why There Are No Data on COVID-19 Vaccination and Pregnancy - TIME

News & FeaturesBill was voted up by the committee one day after they passed a measure that would limit accessto sports for transgender youth

By Associated Press // Jan 22, 2021

HELENA The Montana House Judiciary Committee voted Friday to advance a bill that would ban gender-confirming health care for transgender minors.

Proponents of the bill say it would defend trans children from life-altering medical procedures they cannot fully consent to. Opponents say it would harm trans youth.

The bill passed mostly along party lines, with Republican Rep. Mallerie Stromswold, a recent high school graduate, joining all committee Democrats in opposing the measure.

The bill was voted up by the committee one day after they passed a measure that would prohibit transgender youth fromparticipating in sportsaccording to the gender with which they identify.

Both bills head to the Republican-controlled House floor for votes next week.

Both are opposed by a wide coalition of health care groups, businesses and human rights advocates in the states. The American Civil Liberties Union of Montana has promised to sue the state if the bills are passed into law.

The measure would prohibit medical providers from providing gender-confirming hormone treatment and surgery. Under an amendment passed by the committee Friday, health care providers would still be allowed to provide treatment for certain intersex conditions. Intersex refers to people with genitalia, chromosomes or reproductive organs that dont fit typical definitions for male or female bodies.

The bill would also ban medical providers from referring trans children to other providers for gender-confirming medical care. Health care providers who violate this requirement could be disciplined by licensing bodies, and the states attorney general would be able to enforce compliance.

Rep. Derek Skees, R-Kalispell, defended the ban on referrals after committee Democrats said it would violate doctors rights.

If someone comes in and says I want physician-assisted suicide in Montana you cant refer that to someone that will kill you. So theres plenty of things that doctors cant refer, Skees said.

The vote comes days after President Joe Biden signed an executive order that prohibits discrimination based on gender identity, causing committee Democrats to raise concerns that the states federal education funding could be withheld if the bills are signed into law.

More:
Bill Advances to Limit Trans Youth Health Care in Montana - Flathead Beacon

Betty Lin-Fisher|Akron Beacon Journal

Riley Ickes didnt used to like going to school, but now the 16-year-old cant wait until her school gets back to in-person sessions amidst the COVID-19 pandemic.

Riley thinks a lot of her Ellet High School classmates may not recognize her.

Shes nearly 100 pounds lighter than last March when classes went online at her heaviest 324 pounds. As of this week, she has lost 94 pounds and is still going, thanks to drastic changes in her lifestyle, including nearly daily exercise, diet and bariatric surgery.

More: Summit County Public Health gives drive-thru COVID-19 vaccinations

In September, Riley was one of the first patients to undergo bariatric surgery in a new program at Akron Childrens Hospital. The surgery is not for everyone, but for some patients who have medical conditions that make it difficult for them to lose weight it can be an option, said Dr. Marnie Wagner Walston, a pediatrician who specializes in pediatric obesity medicine and adolescent bariatric surgery.

Walston oversees the hospitals Healthy Active Living program, which provides evaluation and treatment for children and teens who are overweight. The team includes a physician, psychologist, certified nurse practitioner, dietitian and exercise physiologist.

Theres a common misconception that surgery is a quick fix or an easy way out and a patient doesnt have to work, said Walston, who graduated from Firestone High School in 2004.

Patients who want to undergo bariatric surgery still have an eight-to-nine-month process before starting surgery plans, she said.

We're working on healthy lifestyle changes. That might help a patient lose weight without even needing surgery. Thats the ideal situation, Walston said.

But statistics show that for most teens with severe obesity, theyre not going to be successful with behavioral and lifestyle changes alone, she said.

Riley said shes always struggled with her weight.

I've always been a lot bigger than everybody, she said. My mom would take me to different doctors to try to figure out what was going on.

At around age 14, she was diagnosed with polycystic ovary syndrome, an imbalance of hormones, which can also cause fertility issues and obesity. She also had high cholesterol and was pre-diabetic.

Renee Ickes, Rileys mom, said: Shes always been active and shes a good eater but she doesnt eat any different than anyone else. She struggled her whole life and we just tried everything including gym memberships, dieticians and dance classes.

After the diagnosis, they were referred to the Healthy Active Living program.

Everything changed. They're amazing, said Renee.

Surgery was not initially brought up.

She tried all the options and the struggle was there. She just couldnt do it," said Renee Ickes. "The doctor brought it up to us. It took us a while to research and convince everyone it was the right thing.

Adolescent bariatric surgery came about in the 2000s. As procedures have improved, they have become minimally invasive done laparoscopically with minimal incisions and a one- to two-night hospital stay, said Dr. Mark Wulkan, the new chair of Childrens Department of Surgery.

You dont do the operation to be pretty for the prom;it's really about the health benefits, said Wulkan. People think its a cosmetic operation. This is an operation to help reverse a disease [obesity].

There are the same advantages for the patient of doing bariatric surgery in an adult and a teen, which include reducing health risks such as high blood pressure, diabetes, sleep apnea and liver disease, said Wulkan. But studies have shown that those risks are easier to reverse the younger you do the surgery, he said.

That makes the argument that maybe its not a last resort. Maybe its something we should be looking at and it's just one of the tools in your toolbox to treat being overweight," Wulkan said.

He arrived from Atlanta in August. Childrens had already been working on starting the bariatric surgery program before his arrival, but Wulkan, a general surgeon, has a special interest and expertise in bariatric surgery, which he has been performing since 2004. He and Dr. Scott Boulanger will perform the surgeries.

In order for a patient to qualify for bariatric surgery, several factors are considered, including whether the operation outweighs the medical risks and the patients body mass index (BMI) the relationship between height and weight.In addition, the patient must actively participate in a weight-management program for six months.

Even with that, Walston said, not all candidates ultimately have the surgery. There have been three completed (COVID-19 slowed things down) and about 21 patients are working toward surgery. About a quarter of those patients may not pursue surgery, she said.

The patients have to make lifestyle changes, including diet and exercise, before the surgery to make those changes stick after surgery, Wulkan said.

In most pediatric cases, the surgery is a gastric sleeve, where 80 to 85 percent of the stomach is removed. That decreases the capacity of the stomach, so the patient gets full with less. The stomach also produces a hormone that makes you feel hungry. After the surgery, there is less of that hormone, so it decreases your appetite.

It works mechanically and hormonally, Wulkan said.

But that means the body also doesnt signal that it is hungry, Walston said, so patients have to learn how to eat smaller, healthier meals more often. The patients work with experts to make sure theyre eating appropriately and taking vitamins and mineral supplements to make sure there are no nutritional deficiencies.

Surgery helps you reduce the appetite. It's not the fix, said Walston. The surgery itself doesnt remove any weight from the body, but it gives you tools.

The surgerys benefits can be defeated if the patients dont make the lifestyle changes, including exercise and diet, she said.

Candidates for surgery tend to be in their teens, the doctors said, but the team will discuss with a younger patient and family if there is a reason to have the surgery.

"You want to be really thoughtful about the patients emotional ability, ability to be able to live with the implications and understand, Walston said.

Walston is happy that Akron-area adolescent patients have an option for the surgery. Before the hospitals program started, patients had to go to an adult hospital or another region, she said.

Riley enjoys planning and cooking her own meals. She also goes to work out every morning before coming home for online classes while Akron schools are still remote. Riley also works at Walmart after school.

Renee said she doesnt even worry about Riley and her eating habits now.

This kid carries a cooler around with her with chicken. She has her produce and her proteins and she is like an expert in reading all of the labels," Renee said.

Riley is excited to go back to school in person, but concerned about how to keep up the good exercise schedule she's established before school and work.

Her goal weight is 165. Doctors told her shed lose about 75 pounds right after surgery. Shes already exceeded that, and as of this week has lost 94 pounds at 229 pounds.

Her close friends have seen her, but there are a bunch of friends I havent seen since school had let out last March. I dont know what theyre going to say. I'm kind of excited about that.

Shes also excited to get involved with school activities.

With my size, I wasnt comfortable to do anything. I didnt want to. But now if we were back in school, Id probably get into more activities and do more stuff, she said.This week, she ran into her high school band director, who had to do a double-take before he recognized her.

Overall, I feel great. I've never felt this happy with myself, said Riley. She also no longer has high cholesterol and is no longer considered pre-diabetic.

I dont stress out so much. I used to be so concerned when everyone would look at me when I would do something. Now I dont care, and I'm a lot more comfortable with myself.

Riley is especially excited for the day when she can go to Cedar Point and get on a ride. She had avoided until now because she was afraid she wouldnt fit.

Rileys weight-loss journey has changed her career desires. She had been interested in interior design, but now after I went through the clinic and what they do, it really inspired me to want to do that for the kids. She is interested in maybe being a child life advocate or some type of job to work with kids struggling with weight.

Rileys dad, Ron, said it was hard to watch his daughter struggle with her weight and not want to be involved in activities at school.

"With this surgery and the progress shes made, it just totally changed her mental state of mind. I'm starting to see that go-get attitude, he said. For her now to be able to jump in and commit to... taking a hold of nutrition and the routine of the gym, it blows me away to see that.

It's like I have a new daughter, he said.

Beacon Journal staff reporter Betty Lin-Fisher can be reached at 330-996-3724 or blinfisher@thebeaconjournal.com. Follow her @blinfisherABJ on Twitter or http://www.facebook.com/BettyLinFisherABJ To see her most recent stories and columns, go to http://www.tinyurl.com/bettylinfisher

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'I've never felt this happy with myself': Akron bariatric teen patient finds new lifestyle - Akron Beacon Journal

Our body needs a healthy immune system to defend itself against germs. In the midst of the COVID-19 pandemic and flu season, you need a healthy immune system more than ever.

Tereza Hubkova, MD, ABIHM, ABIM, is an integrative medicine physician at AdventHealth Shawnee Mission. According to Dr. Hubkova, our immune system is strongly influenced by our lifestyle: the foods we eat, how we sleep, our physical activity and even our mood and level of stress.

Proper nutrition is key. You want to make sure your diet provides all the nutrients your immune system needs and that your body is not in a pro-inflammatory state in case you would catch COVID.

The life-threatening complication of COVID, the cytokine storm, happens when the immune system goes into overdrive and the immune response itself causes too much collateral damage. Our Western diet full of processed foods, sugar, salt and unhealthy fat puts many Americans at risk. Instead, we need fresh produce full of vitamins and colorful polyphenols, minerals, fiber, protein and healthy fats (including omega 3 fatty acids from seafood).

Our age affects our immune system as well children and young adults are less likely to be affected by COVID than older people.

Even just one night of poor sleep severely impairs our ability to deal with viruses, said Dr. Hubkova. When partially sleep deprived, we produce 75 percent less natural killer cells that could eliminate viruses. As we get older, we also produce less melatonin, a hormone crucial for a healthy immune system. Stress and blue light from our electronic screens suppress melatonin production as well.

Dr. Hubkova also advises to be sure your Vitamin D level is in the optimal range.

Patients in intensive care due to severe COVID almost always have low vitamin D level, said Dr. Hubkova.

We make Vitamin D in our skin when we are exposed to sunshine, but our modern indoor lifestyle means that Vitamin D deficiency is extremely common. We do not get much Vitamin D from food, so besides spending more time outdoors, taking a Vitamin D supplement may be the next best solution, especially in the winter.

Between the COVID pandemic and cold weather, many people are not getting out much and interacting with others, which is likely contributing to anxiety and depression and affecting our immune system as well.

Our immune system has receptors for the molecules of emotion, said Dr. Hubkova. It knows when we are happy or sad, and it works much better when we are in a positive state of mind.

Finally, is there any advice for COVID vaccination?

In general, we do not respond well to vaccines when our immune system is weakened, such as by stress or sleep deprivation, said Dr. Hubkova. While we do not know everything about the COVID vaccine yet, try to get a good nights sleep the night before you get vaccinated.

Dr. Hubkova has created the 21-day immunity challenge designed to get your immune system in better working order by addressing a few key lifestyle habits, one day at a time. Learn more about the 21-day immunity challenge at MyHealthKC.com.

Original post:
The immune system and COVID-19 - Shawnee Mission Post

Hope S. Rugo, MD, FASCO, describes working in medical oncology as a tapestry of experiences. In her case, its a very rich, complicated piece of art.

The 2020 Giants of Cancer Care award winner in the education category is at the forefront of the exploration and development of novel targeted therapies and immunotherapy for patients with breast cancer, including combinations that may overcome resistance, and of strategies to alleviate adverse effects of cancer treatment. She serves in leadership roles for several collaborative clinical investigations and is a noted lecturer at conferences throughout the world.

Through it all, Rugo prizes her relationships with patients. She maintains an active clinical practice at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, where she is a professor in the Department of Medicine and the director of breast oncology and clinical trials. At UCSF, she leads the Breast Forum, a discussion platform for patients, families, and caregivers.

Its that tapestry that really creates this rich experience. I have had amazing interactions with patients who were remarkable and courageousindividuals who I feel really taught me a lot about life and gave me lessons that I brought back to other patients, Rugo said in a recent interview with OncLive News Network. I continuously learn from my patients and I love those interactions. Breast oncology, in some ways, is amazing because we can know an individual for many, many years and see them quite frequently; we know a lot about those patients and their families and how theyre dealing with these incredible challenges.

Rugo will join other leading breast cancer experts in translating her vast clinical knowledge for oncology specialists at the virtual 38th Annual Miami Breast Cancer Conference (MBCC), which Physicians Education Resource, LLC (PER) is hosting March 4 to 7, 2021. PER named Rugo as its 2020 Educator of the Year in recognition of the role she plays in sharing her insights with the cancer care community.

Patrick I. Borgen, MD, chair of the Department of Surgery and head of Maimonides Breast Center at Maimonides Cancer Center, both at Maimonides Medical Center in Brooklyn, New York, serves as program chair for MBCC. Rugo is cochairing the conference with Anees B. Chagpar, MD, MBA, MSc, MPH, a professor in the Department of Surgery at Yale School of Medicine in New Haven, Connecticut, and Debu Tripathy, MD, professor and chairman of the Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston.

The MBCC agenda always features important new data and expert insights on treatment approaches across the care spectrum and is updated after the San Antonio Breast Cancer Symposium (SABCS 2020) to present the latest information to attendees.

There are just so many things going on that are really exciting right now in breast cancer, Rugo said. Miami Breast is great because it includes the new data in surgery, in radiation oncology, and in medical oncology, and both early-stage and metastatic disease.

One of the hallmarks of the conference is the give-and-take between speakers and audience members, which helps to provide valuable perspective on the latest data. MBCC focuses not only on the latest data, but also on how to apply that data in the clinic.

We do have selected debates about controversial areas, Rugo said. Were going to talk about where we want to de-escalate treatment, where we want to escalate it, and how were using our increasing knowledge of cancer biology to apply this [information].

We talk a lot about how [treatment] impacts the patient. What are the impactsin terms of fertility? Weve talked about cardiac effects, and patient-reported outcomes, how we treat patients who are older versus younger, she continued. We really try to cover all of the very clinically pertinent information and the information thats come out of the most recent presentations and publications. And then theres the ability to discuss this and ask questions with the presenters, which is, I think, really great.

Rugo will be putting into perspective the evolving treatment landscape for patients with estrogen receptorpositive, high-risk, early-stage breast cancer and will present data on novel oral therapies. She expects that recent findings involving antibody-drug conjugates (ADCs), tyrosine kinase inhibitors (TKIs), CDK4/6 inhibitors, and the use of circulating tumor DNA as a predictive biomarker will be key points of discussion.

There have been so many exciting studies presented this year which are practice changing that I think the Miami Breast meeting is a perfect time to really put this all together in a clinically applicable state, she said. And by being virtual, youll have access to everyone, and in some ways its even easier to attend.

Rugo is anticipating a busy year in breast cancer research, with investigators building upon many recent advancements. She said that noteworthy findings likely to change practice this year and beyond include research presented at SABCS 2020 into the clinical utility of the Oncotype DX Breast Recurrence Score test, immunotherapy in neoadjuvant and metastatic settings, and emerging novel therapies.

Her own research led to a significant development when the FDA approved margetuximab-cmkb (Margenza) in combination with chemotherapy for adults with metastatic HER2-positive breast cancer who have previously received 2 or more antiHER2 regimens, at least one of which for metastatic disease, in December 2020.

Rugo was the principal investigator for the phase 3 SOPHIA trial (NCT02492711), which showed that the Fc-engineered monoclonal antibody plus chemotherapy reduced the risk for disease progression or death by 24% compared with trastuzumab (Herceptin) plus chemotherapy. The median progressionfree survival (PFS) was 5.8 months (95% CI, 5.5-7.0) in the margetuximab-cmkb arm compared with 4.9 months (95% CI, 4.2-5.6) with the trastuzumab regimen (HR, 76; 95% CI, 0.590.98; P = .033).1,2

Investigators observed an objective response rate (ORR) of 22% in the margetuximab arm versus 16% with trastuzumab. Drug maker MacroGenics plans to release overall survival (OS) data in the second half of 2021. The company said that margetuximab is the first HER2-targeted therapy to demonstrate improved PFS compared with trastuzumab in a head-to-head phase 3 clinical trial.

ADCs and TKIs

In the past 13 months, the FDA has granted accelerated approvals for 2 novel ADCs: fam-trastuzumab deruxtecan-nxki (Enhertu), for patients with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior antiHER2- based regimens in the metastatic setting3; and sacituzumab govitecan-hziy (Trodelvy), for patients with metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior therapies for metastatic disease.4

In December 2019, the FDA approved trastuzumab deruxtecan based on findings from the DESTINY-Breast01 trial (NCT03248492), in which the agent demonstrated an ORR of 60.3% (95% CI, 52.9%-67.4%), with a 4.3% complete response (CR) rate and a 56% partial response rate among 184 patients. The median duration of response (DOR) was 14.8 months (95% CI, 13.8-16.9).3

In updated results presented at SABCS 2020, the median DOR expanded to 20.8 months. The estimated 12- and 18-month overall survival (OS) rates were 85% (95% CI, 79%-90%) and 74% (95% CI, 67%-80%), respectively. The median PFS was 19.4 months (95% CI, 14.1-not estimable [NE]), and the preliminary median OS, although still immature, was 24.6 months (95% CI, 23.1-NE).5 In April 2020, the FDA approved sacituzumab govitecan based on findings from the phase 1/2 IMMU-132-01 trial (NCT01631552), which showed an ORR of 33.3% (95% CI, 24.6%-43.1%) with a median DOR of 7.7 months (95% CI, 4.9-10.8).4

Survival data from the phase 3 ASCENT trial (NCT02574455), presented at the European Society for Medical Oncology Virtual Congress 2020, showed that sacituzumab govitecan improved median OS by more than 5 months compared with chemotherapy (12.1 vs 6.7 months; HR, 0.48; 95% CI, 0.38-0.59; P < .0001). Median PFS for participants who received sacituzumab govitecan was 5.6 months (95% CI, 4.3-6.3) compared with 1.7 months (95% CI, 1.5-2.6) for patients who had chemotherapy (HR, 0.41; 95% CI, 0.32-0.52; P < .0001).6

The ADC also demonstrated an ORR of 35% versus 5% with physicians choice of chemotherapy. Ten (4%) patients in the experimental arm had CRs compared with 2 (1%) in the control group.6

Further, the FDA also approved tucatinib (Tukysa), a HER2-directed TKI, in combination with trastuzumab and capecitabine in April 2020, for patients with advanced unresectable or metastatic HER2-positive breast cancer. The approval includes patients with brain metastases who have received at least 1 prior antiHER2-based regimen in the metastatic setting.7

The agency based its decision on results from the HER2CLIMB trial (NCT02614794), in which the tucatinib-containing combination demonstrated a median PFS of 7.8 months (95% CI, 7.5-9.6) compared with 5.6 months (95% CI, 4.2-7.1) for patients who received placebo plus standard therapy (HR, 0.54; 95% CI, 0.42-0.71; P < .00001). The median OS was 21.9 months (95% CI, 18.3-31.0) with the addition of tucatinib versus 17.4 months (95% CI, 13.6-19.9) with standard therapy alone (HR, 0.66; 95% CI, 0.50-0.87; P= .00480).7

At SABCS 2020, investigators reported that the tucatinib regimen reduced the risk of deterioration of health-related quality of life in patients with brain metastases by 49% versus standard therapy (HR, 0.51; 95% CI, 0.28-0.93).8

We have ADCs that are changing care for HER2-positive and for triple-negative disease with trastuzumab deruxtecan and sacituzumab govitecan. We have now a very potent and less toxic oral TKI, tucatinib, which has been combined with capecitabine and trastuzumab and results in not only improved PFS but improved OS in the metastatic setting and in patients with active brain metastasesvery exciting data that have led to new studies, Rugo said.

Were going to see data in the next year about the efficacy of these ADCs in other populations, such as patients with newly defined HER2-low diseasenot HER2 positive but not zero by IHC [immunohistochemistry]and also the ADC sacituzumab govitecan-hziy in [hormone receptor]positive disease. There are, I think, really intriguing studies that will potentially allow us to further expand the use of this highly effective therapy, she said.

The adverse event profile of a new therapy also must be taken into consideration, Rugo noted. It is always important to understand toxicity with novel agents, she said. Trastuzumab deruxtecan has a relatively novel toxicity that is worth mentioning as it is so important for clinicians to recognize and understand. Interstitial lung disease [ILD] or pneumonitis can be seen with this ADC, and the mortality in the phase 2 trial was 2.7%. Current guidelines provide careful and detailed recommendations for managing this toxicityholding the ADC for grade 1 asymptomatic ILD seen only on imaging, and permanently discontinuing along with steroid treatment for grade 2.

CDK4/6 Inhibitors

According to Rugo, data presented at SABCS 2020 suggest an exciting future for CDK4/6 inhibitors. Results from an updated analysis of the phase 3 MONALEESA-7 trial (NCT02278120) showed that adding ribociclib (Kisqali) to endocrine therapy continued to significantly improve OS and delay subsequent chemotherapy compared with placebo, irrespective of endocrine partner, in pre- and peri-menopausal patients with hormone receptorpositive, HER2-negative breast cancer in combination with suppression of ovarian function.

At a median follow-up of 53.5 months (range, 46.9-66.4), median OS with ribociclib plus endocrine treatment was 58.7 months versus 48.0 months with placebo/endocrine therapy (HR, 0.763; 95% CI, 0.608-0.956), translating into a 24% relative reduction in risk of death with the CDK4/6 inhibitor.9

We saw the updated survival data for MONALEESA-7, [which were] very impressive in young women, Rugo said.

The conference also featured the primary outcome findings from monarchE (NCT03155997). The phase 3 trial tested the CDK4/6 inhibitor abemaciclib (Verzenio) in combination with standard-of-care endocrine therapy versus endocrine therapy alone in 5637 patients with HER2-positive, hormone receptorpositive, node-positive, high-risk early breast cancer.

Results showed that adding abemaciclib significantly improved invasive disease-free survival (iDFS) compared with standard endocrine therapy alone (HR, 0.713; 95% CI, 0.583-0.871; P = .0009) in the intention-to-treat population. This translated into a 28.7% relative reduction in the risk of developing an iDFS event.10

In further analysis of the study data, investigators suggested that high expression of Ki-67, a protein marker of cellular proliferation, potentially could be used in conjunction with clinicopathological features to indicate which patients have a greater risk of recurrence and might have the greatest benefit from the addition of the CDK4/6 inhibitor.

Although patients benefited from abemaciclib therapy regardless of Ki-67 expression, outcomes were worse for those with a high level, defined as 20% or greater on IHC testing. These patients had a lower rate of 2-year iDFS of 91.3% (95% CI, 88.9%-93.2%) compared with 94.7% (95% CI, 92.8%-96.1%) for patients with a Ki-67 low score.11

The study marked the first time the prespecified threshold for high Ki-67 was used prospectively with a standardized assay in a phase 3 trial, investigators said. Rugo is excited about the potential for its use as a biomarker. Its not just clinical features, like stage and grade, but also Ki-67 is emerging as an incredibly important factor, Rugo said. I think this is likely to be practice changing in the next year.

Targeted Therapy

Findings that Rugo and colleagues presented at SABCS 2020 for alpelisib (Piqray), a PI3K inhibitor, are likely to inform treatment choices for a subset of patients with hormone receptorpositive, HER2-negative progressive metastatic disease. In the ongoing phase 2 BYLieve trial (NCT03056755), investigators are evaluating alpelisib in patients with previously treated PIK3CA-mutant hormone receptorpositive, HER2-negative advanced breast cancer.12

The trial has 3 arms: cohort A, testing alpelisib plus fulvestrant (Faslodex) in patients whose immediate prior treatment was a CDK4/6 inhibitor plus an aromatase inhibitor (AI); cohort B, evaluating alpelisib plus letrozole in patients whose immediate prior treatment was a CDK4/6 inhibitor plus fulvestrant; and cohort C, testing alpelisib plus fulvestrant in patients who progressed on or after AI therapy and then received chemotherapy or endocrine therapy as their immediate prior treatment.12

Results were presented for 115 patients in cohort B, in which 82% of participants had progressed on prior AI therapy. A total of 46.1% of patients were alive without disease progression at 6 months per local investigator assessment (n = 53; 95% CI, 36.8-55.6), meeting the primary end point of the study. At a median follow-up of 15 months, the combination of alpelisib and letrozole led to a median PFS of 5.7 months (95% CI, 4.5-7.2).

In this cohort, the majority of patients had previously been exposed to an AI and had had progression on that treatment, so this is really the most endocrine-resistant population that has been treated with alpelisib combined with an endocrine therapy, Rugo said.

The median PFS, she noted, is quite impressive for a patient population treated with an AI after exhibiting resistance to an AI.

The research Rugo presented at SABCS 2020 provides a glimpse at her expansive accomplishments as a clinical investigator, starting in the late 1980s while she was a hematology and oncology fellow at UCSF.

Over the years, she has served as the principal investigator in more than 60 clinical trials, many of which led to major discoveries. Specifically, Rugo led studies exploring the use of agents such as palbociclib (Ibrance) and abemaciclib, and was a member of the steering committees for multiple clinical trials including for the ABRAZO and EMBRACA studies (NCT02034916 and NCT01945775) evaluating the PARP inhibitor talazoparib (Talzenna) in patients with BRCA-mutant metastatic breast cancer.

In the immunotherapy field, Rugo was a primary investigator for the IMpassion130 trial (NCT02425891), which led to the March 2019 FDA approval of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) for patients with unresectable, locally advanced PD-L1positive TNBC. This marked the first immune checkpoint inhibitor to be approved for the treatment of breast cancer.13

She also was on the steering committee for the KEYNOTE-355 trial (NCT02819518) testing pembrolizumab (Keytruda) plus chemotherapy for patients with TNBC and presented a subset update at SABCS 2020. The results of this trial led to FDA approval of pembrolizumab plus either nab-paclitaxel, paclitaxel, or gemcitabine with carboplatin for PD-L1positive TNBC in November 2020.14

Rugo is actively involved in the multicenter adaptively randomized I-SPY 2 trial, where she is chair of the safety committee and serves on the novel agent committee, publishing the results of 1 of the first arms of the trial (paclitaxel plus veliparib-carboplatin).15

Rugo also has made relieving toxicities of cancer treatment part of her mission. She was the principal investigator for a study evaluating the DigniCap Scalp Cooling System, which uses scalp cooling technology to help prevent chemotherapy-related hair loss. In 2017, DigniCap became the first FDA-approved cooling cap for patients with solid tumors.16 She also led the 2017 SWISH trial (NCT02069093), which investigated a dexamethasone-based mouthwash that reduces stomatitis and mouth and lip inflammation in patients with metastatic breast cancer receiving treatment with everolimus (Afinitor). Findings showed that the oral solution reduced the severity of stomatitis, and the mouthwash has been used ever since.17

These are projects we all have worked on together and as a community have been able to really make a difference for patients who are being treated with these agents understanding the time course of toxicity, she explained. These have been really great to work on.

One of Rugos lasting contributions to the field is likely to be in training junior faculty and helping patients and their families understand their options for treatment. She also runs UCSFs Breast Forum, an open bimonthly evening educational session for patients with breast cancer and their families and friends.

Rugo is a master educator and clinician, according to Laura J. Esserman, MD, MBA, the 2018 Giants of Cancer Care award winner in the cancer diagnostics category. Not only is she good at educating residents and other physicians and scientists, but she is fantastic at educating her patients about what their risks are, what their options are, said Esserman, the Alfred A. de Lorimier Endowed Chair in General Surgery and director of the Carol Franc Buck Breast Care Center at UCSF Helen Diller Family Comprehensive Cancer Center. She has that amazing talent for putting information together in such a way that people can make better decisions.

According to Rugo, her experiences in medical education not only taught her how to convey information, but also help her better relate to her patients and colleagues. She considers herself very fortunate to have worked in the field, both nationally and internationally, and credits her career choice and focus to her mother, who died of breast cancer more than 20 years ago.

That also gives you lots of ideas about clinical research and it keeps you in touch with the community at large, she said. Then you learn a lot about other cultures and how people manage different aspects of both cancer care and life and death issues as wellthats been an amazing experience.

References

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Rugo Sets the Stage for a Busy Year in Breast Cancer - OncLive

People who are transgender have been turned into a medically and socially vulnerable group who face numerous health disparities. As the coronavirus outbreak brings acute mental distress to many specific groups of people raising international health concerns, trans people too face unprecedented difficulties in their bodily and social well being, along with difficulties in accessing health care, which have placed a tremendous burden on them.

Even before the pandemic there were many cisgender hurdles to trans people accessing health care: such as a dearth of specialised health professionals. As a result, very few transgender individuals received general medical care, hormone interventions, or gender affirmation surgeries, especially in low and middle income societies.

Sidelined by society, the inequalities imposed on transgender people by legislation or rules based on the gender binary, or by other social aspects, have increased their risk of infection, disease and mortality during the COVID19 crisis.

Most hospitals in India and many other countries, in trying to prevent the potential overload of health systems by patients of COVID19, have postponed, cancelled or simply stopped providing elective procedures to save their inadequate resources.

This has made it even more difficult for trans people to approach doctors for general medical care, HIV treatment, hormone interventions or gender affirming surgeries.

In India the lockdown left people who are trans at greatly increased risk of poverty and ill health: because they are made to exist on societys margins, often earning a livelihood through sex work or begging work.

According to a social worker at the Tata Institute of Social Sciences, Mumbai who wished not to be named:

It is a grim reality seen in India, as though a number of NGOs and corporates were seeing feeding the poor on the streets, distributing masks and other essential things, Indias third gender hijras have been largely overlooked. From any sector or community, no organised help was coming to them. The transgender people do not get help or assistance from their family members or any help from society.

And according to a hijra-transgender person from Hyderabad who declined to be named:

We do not have the social privilege of operating within a distant online world when we know our lives are precariously balanced on the thread of social interaction and functions. Only our trans community members have helped each other during this global health calamity.

As the health and well being of the Trans community has suffered decades of institutional neglect, the pandemic has especially intensified their suffering.

Many of my community members dont get called to a childbirth event now, or to a marriage ceremony after the coronavirus outbreak, and we are left with no choice. Due to this loss our community members are at health risk because of increasing hunger and poverty, said Rani, a trans woman.

There are many challenges which Trans community members face during the pandemic, and a few of them are very critical.

Most measures introduced by our governments and assemblies have focused on women, senior citizens, and people with disabilities. They do not address the needs of LGBTQI individuals.

It was found that a lot of trans people are living with HIV, which leads to their being immunocompromised. As such they need special care at this point. While anti-retroviral therapy (ART) centres are currently open and dispensing medicines, there may be a lack of doctors. And with public transport systems brought to a halt, people living with HIV were not able to access the hospitals where they were registered for treatment.

Trans people undergoing hormone replacement therapy (HRT) were unable to access their doses, or pharmacists who were ready to administer the hormone injections.

It was also reported that Trans activists demand separate quarantine wards for the community as currently wards are segregated under the gender binary, causing them further problems and trauma.

There were a few cases in Delhi and other Indian cities where discrimination and stigma were perpetrated on Trans persons trying to access health services.

In a few instances, doctors refused to give Trans women a prescription for a COVID19 test in public hospitals.

A trans woman from Mumbai was reported to have been kept in a male ward when admitted to hospital for treatment.

Cisgender society also spread rumours in Bangalore claiming that Trans individuals and Hijras were the main carriers of the new coronavirus.

According to a Trans activist in Bangalore who asked not to be named:

At many hospitals, the constant misgendering we faced at the hands of healthcare professionals was very traumatising, and this trauma has only worsened during COVID19, when frontline health workers were found not to have been sensitised to trans health.

To escape this trauma, some Trans women have resorted to unscientific castration, leading to urinary tract infections and kidney related problems.

Significantly, there are also subsection differences in transgender individuals physical and mental health needs. According to a physician based in Mumbai:

During the pandemic transgender women have faced additional health problems compared with transgender men. To prevent harmful consequences caused by barriers to healthcare when resources are limited, governments should try to implement urgent solutions to guarantee general medical care, prescription supply, such as hormones, and provide remote online physician counselling for transgender individuals.

In response to the ongoing health emergency, it is proposed that governments and the commercial sector should keenly consider the unprecedented difficulties and conditions imposed on Trans people, and implement corrective strategies to serve this group marginalised by cisnormative society.

This may include addressing the humiliation, stigma and other issues that make trans people more vulnerable to health hazards, extending equal rights and legal protections to transgender individuals, and revising the medical curriculum to include a chapter on transgender health.

Dr Dhananjay D. Mankar (MD, PhD) is assistant professor at the Centre for Hospital Management, School of Health Systems Studies, Tata Institute of Social Sciences, Mumbai

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Surviving while Trans: Hijras and Others Face Life Threatening Covid Problems - The Citizen