BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (NASDAQ:LVGO) are both medical companies, but which is the better stock? We will compare the two companies based on the strength of their risk, institutional ownership, profitability, earnings, valuation, analyst recommendations and dividends.

Institutional and Insider Ownership

0.1% of Livongo Health shares are owned by institutional investors. 17.9% of BioRestorative Therapies shares are owned by company insiders. Strong institutional ownership is an indication that hedge funds, endowments and large money managers believe a stock will outperform the market over the long term.

Analyst Recommendations

This is a breakdown of recent ratings and recommmendations for BioRestorative Therapies and Livongo Health, as reported by MarketBeat.

Livongo Health has a consensus target price of $44.30, indicating a potential upside of 71.17%. Given Livongo Healths higher probable upside, analysts plainly believe Livongo Health is more favorable than BioRestorative Therapies.

Profitability

This table compares BioRestorative Therapies and Livongo Healths net margins, return on equity and return on assets.

Valuation & Earnings

This table compares BioRestorative Therapies and Livongo Healths top-line revenue, earnings per share (EPS) and valuation.

BioRestorative Therapies has higher earnings, but lower revenue than Livongo Health.

Summary

Livongo Health beats BioRestorative Therapies on 7 of the 9 factors compared between the two stocks.

BioRestorative Therapies Company Profile

BioRestorative Therapies, Inc. develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells for the treatment of disc/spine disease and metabolic disorders. The company's lead cell therapy candidate is the BRTX-100, which focuses on providing non-surgical treatment for protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. It also develops the ThermoStem program, a pre-clinical program for the treatment of metabolic diseases, such as type 2 diabetes, obesity, hypertension, and other metabolic disorders, as well as cardiac deficiencies. In addition, the company provides curved needle device, a needle system with a curved inner cannula that allows access to difficult-to-locate regions for the delivery or removal of fluids and other substances. Further, it offers skin care products under the Stem Pearls brand name. BioRestorative Therapies, Inc. has a research and development agreement with Rohto Pharmaceutical Co., Ltd.; and a research agreement with Pfizer, Inc. and the University of Pennsylvania. The company was formerly known as Stem Cell Assurance, Inc. and changed its name to BioRestorative Therapies, Inc. in August 2011. BioRestorative Therapies, Inc. was incorporated in 1997 and is headquartered in Melville, New York.

Livongo Health Company Profile

Livongo Health, Inc. provides an integrated suite of solutions for the healthcare industry in North America. It solutions promote health behavior change based on real-time data capture supported by intuitive devices and insights driven by data science. The company offers a platform that provides cellular-connected devices, supplies, informed coaching, data science-enabled insights, and facilitates access to medications. Its products include Livongo for Diabetes, Livongo for Hypertension, Livongo for Prediabetes and Weight Management, and Livongo for Behavioral Health by myStrength. The company was formerly known as EosHealth, Inc. and changed its name to Livongo Health, Inc. in 2014. Livongo Health, Inc. was incorporated in 2008 and is headquartered in Mountain View, California.

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Financial Contrast: BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (OTCMKTS:LVGO) - DFS Caller

Recommendation and review posted by Bethany Smith

'Women know nothing about menopause, then it hits them over the head like a ton of bricks'

BelfastTelegraph.co.uk

Not only do we not talk nearly enough about menopause - something that affects half the people on the planet, with menopausal women the fastest growing demographic section in the world - but most of the conversations we do have, are misplaced. We spend too much time talking about HRT versus no HRT, about breast cancer risks, even debating whether or not menopause is a 'thing'.

https://www.belfasttelegraph.co.uk/life/health/women-know-nothing-about-menopause-then-it-hits-them-over-the-head-like-a-ton-of-bricks-38682571.html

https://www.belfasttelegraph.co.uk/life/features/article38682570.ece/6fd38/AUTOCROP/h342/2019-11-12_lif_54832131_I5.JPG

Not only do we not talk nearly enough about menopause - something that affects half the people on the planet, with menopausal women the fastest growing demographic section in the world - but most of the conversations we do have, are misplaced. We spend too much time talking about HRT versus no HRT, about breast cancer risks, even debating whether or not menopause is a 'thing'.

In fact, we should be talking about heart health, osteoporosis, and Alzheimer's. We should be talking, at a most fundamental level, about what is a significant health occurrence, one that now, because of rising life-expectancy, comes roughly midway through a woman's life, and that will have a considerable impact on physical and mental wellbeing.

The conversation we need to be having isn't the slightly judgemental one around women's 'choices', it is around the health impact of the menopause and what to do about it.

At its simplest, menopause marks the end of a woman's reproductive phase. The ovaries no longer release an egg every month and menstruation stops. Production of oestrogen diminishes gradually in the years before menopause, accelerating in the last year or two.

This is the point at which women will generally begin to notice symptoms - there is a check-list of over 40 possible, from the well-known (hot flushes, night sweats, insomnia), to the less recognised: panic attacks, painful joints, dry eyes. Some are life-threatening, and some are life-limiting.

Obviously the different reactions of women are dictated by the severity of symptoms - and every woman is different, every woman will have a different menopause, just as we all had different experiences of puberty and hormonal cycles.

However, symptomatic responses aside, the fundamental reality of menopause is that depleted oestrogen has consequences for the whole of a woman's health, no matter how well she is managing her symptoms, and it is this that needs to be talked about, and understood.

"The problem is, women know nothing," says Barbara Taylor MD (menopausetaylor.me), who was an obstetrician and gynaecologist at the Texas Medical Centre, before she retired due to severe arthritis and threw herself into educating women about menopause.

"They don't know what menopause is, when it hits them over the head like a ton of bricks. They go through years of seeing doctors for all these different things. They see one person for their joint pain, someone else for their insomnia, they don't realise it's all one thing, that losing your oestrogen involves a whole list symptoms that make you miserable.

"It's not even about the symptoms, it's about the fact that when you lose your oestrogen, you are at higher risk of heart attack, osteoporosis and Alzheimer's, simply by virtue of losing something your body needed to function.

"It's a deficiency state. If you lose your insulin, you have 20 symptoms that make you miserable, and if you don't do something about it, you die. If you lose your thyroid hormones, ditto. So why do we not respond when we lose our oestrogen? Your body is trying to tell you something. And if you don't listen to it, it's going to get worse."

Barbara's mission is education. "I help women manage their menopause whatever way they want. I have no agenda, no product. This is a purely educational resource for women, on all of their options - diet, lifestyle, vitamins, minerals, herbs, hormonal medications, non-hormonal medications, acupuncture... All I do is teach."

Barbara emphasises the importance of understanding personal risk factors. "For example, one glass of red wine is good for reducing your risk of heart attack. But that same glass of red wine increases your risk of breast cancer. So you need to understand - what are your personal risk factors? Are you more at risk of breast cancer? Of stroke? Of heart attack? And act accordingly."

She emphasises that "one in every two deaths of post-menopausal women in America is from heart disease" - low levels of oestrogen pose a significant risk of developing disease in smaller blood vessels - "compared with 1 in 29 from breast cancer. And yet we talk far more about the breast cancer risk. We're looking the wrong way."

Women, she says, consult with her from all over the world, and the two biggest complaints are: "One, their vaginas are on fire - vaginal irritation is the biggest, most bothersome symptom - and they won't talk about it. They will talk about hot flushes, but not vaginal discomfort. Two, is insomnia, because when you don't get sleep, everything else is off track and awful. Those are the two biggest and most obvious complaints. But, once they get some information, what they want to know is, 'How can we be at such huge risk of heart attack, Alzheimer's and osteoporosis, and not know it'?"

Many women come to Barbara determined against HRT, and many of those reconsider in the light of the information.

"I see more converting to HRT than anything," she says. But the endgame is not conversion - to anything - it's education.

"Each woman has a journey, finding what works best for her. When they do find it, they are so shocked at how different their lives can be."

Most women who come to see Nigel Denby, dietitian and nutritionist at the Hormone Health clinic, come because of the weight.

Nigel explains: "They find this extra stone, stone-and-a-half, all in the mid-section. Often, they aren't eating more, they haven't stopped exercising, so why is this happening? Oestrogen levels are falling and the way your body lays down its fat changes. This is a symptom of menopause." Here, Nigel gives some advice to women going through 'the change'.

Diet won't "give you a 'natural HRT'. It just won't. Let's lay that to rest".

In terms of diet and lifestyle, you need to "take care of your bones, look after your heart, and sort out this menopausal midriff weight gain".

"The second your oestrogen starts falling, your risk of a heart attack goes up to the same as a man's. You've had protection all your life, until now. This is the biggest killer in the UK and the second biggest in Ireland, and nobody talks about that."

Essentially, you may need to learn to eat and exercise differently.

"What you're trying to do is wind back time," he says. "Your body is ageing. You're losing muscle tissue, laying fat down in a different way. You need to reverse that. And you're not going to do it by a couple of gym classes a week. It has to be every single day. It's hard work.

"First, get yourself active. Look at your day-to-day stuff. Are you getting your 10,000 steps in? If not, nothing you do in the gym is going to make a difference. Combine it with resistance exercise, focusing on thighs, gluts, abs, upper body and arms. wDo squats, abdominal curls, box press-ups, 4x10 reps every day. Work until your muscles are tired. That's going to generate muscle tissue that is going to speed up your metabolic rate."

As for diet: "If you are going to lose weight, you've got to cut out about 300-500 calories a day. Start with a food and activity diary.

"For most people, the extra calories come from booze and large portion sizes; most of us are eating way too much."

But, he emphasises: "All of that needs to happen while taking care of your bones and your heart health. You need two to three servings of dairy and consider supplementing with vitamin D. Try and eat more fruit and veg, more oily fish and soluble fibre."

Remember that: "You have another four decades in front of you, and the quality of those decades is down to you.

"If a woman focuses on the facts and not the hype, she can give herself the best years of health ahead of her."

And, he adds: "I love this work, because women at this phase of their lives are the most motivated women I work with."

The bad news is that there is no one test you can do to show you where you are in your fertility lifespan. GPs will do a blood test to establish your levels of follicle-stimulating hormone (FSH) and to rule out other possible causes, such as thyroid issues or vitamin deficiencies.

If your FSH blood levels are 30 mIU/mL or higher, together with absence of periods for 12 months, that suggests you have reached menopause.

However, testing during the years before menopause (known as peri-menopause), when FSH may be within normal range but oestrogen is dwindling, is more a question of symptom-checking, as blood tests are unreliable: hormone levels fluctuate constantly, so a blood test is a snapshot of a particular moment, rather than an overall picture.

Instead, it's a question of a balanced assessment of a woman's age, her symptoms, including changes to the menstrual cycle, and how she feels, after having ruled out other possible causes.

Belfast Telegraph

Read more:
'Women know nothing about menopause, then it hits them over the head like a ton of bricks' - Belfast Telegraph

Recommendation and review posted by Bethany Smith

Patients

Between Jun 11, 2012, and May 272,016, 228 Chinese women underwent vaginal repair for CSD at Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine. These women all had prolonged postmenstrual spotting and underwent treatment in our hospital. The research protocol was approved by the relevant Institutional Review Board before the study began. This study was approved by the Ethics Committee of Shanghai First Maternity and Infant Hospital, affiliated with Tongji University (KS1512), and was conducted in accordance with the Declaration of Helsinki.

We reviewed and collected the patients medical records and follow-up data after they provided informed consent. All participants gave written informed consent before the study began. The author(s) agreed to provide copies of the appropriate documentation if requested. Baseline clinicopathologic data, including delivery times, menstrual cycle, age, gravidity, parity, age at first C-section, number of C-sections, hemoglobin (Hb) and data from MRI imaging, were also recorded before surgery. Laboratory analysis of Hb was conducted via a regular blood test within 3days of surgery.

Patients treated by vaginal surgery were included in the study with the following criteria: 1) clinical features, such as longer menstruation after C-section and no significant change in the menstrual cycle; 2) history of C-section; and 3) CSD detected by MRI. Exclusion criteria included uterine pathologies, such as adenomyosis, leiomyoma and other conditions [21].

Each patient received continuous epidural anesthesia while in the lithotomy position. At a distance of 0.5cm below the site of the reflexed vesicocervical area,an anterior incision was made from the 3 oclock position to the 9 oclock position using an electric knife. The bladder was carefully dissected away from the uterus with sharp dissection scissors toward the abdominal cavity until the peritoneum was reached. Once the abdominal cavity was entered and the cervical and lower uterine segments were exposed. The CSD tissue was cut to the normal healthy muscle. The incision was closed with a double layer of 10 absorbable interrupted sutures. After adequate hemostasis, the peritoneum and bilateral bladder column were sutured, followed by the incision in the cervical vaginal area.

Patients included in the study had follow-up clinic visits to record their menstruation at 1, 3 and more than 6months after the procedure and measure the CSD scar site by MRI at more than 6months after the procedure. According to the previous study, patients menstruation would likely plateau at follow-up visits more than 3months after surgery [21]. The data from MRI were evaluated at the same center by an experienced radiologist. The data after surgery mainly included the number of menstruation days and the depth, length, width, and thickness of the remaining muscular layer (TRM) as well as the depth/ TRM ratio based on contrast-enhanced MRI [21](Fig. 1). Primary outcomes were the number of postmenstrual spotting days and depth/ TRM ratio. All events and any modifications that occurred during follow-up were recorded.

We defined the Class-A healing group as CSD patients who had menstruation duration of no more than 7days and a thickness of the remaining muscular layer of no less than 5.8mm after vaginal repair, and all other patients were included in the non-class-A healing group [28].

Patient characteristics and preoperative factors were analyzed using students t test and chi-square tests. Ages are given as the medians with ranges, others variables are expressed as meanSD. Multivariate logistic regression models were used to assess risk factors associated with non-class-A healing of CSD. Regression coefficients were used to generate prognostic nomograms. Model discrimination was measured quantitatively with the concordance index. Internal validation was performed using 1000 bootstrap resampling to quantify the overfitting of our modeling strategy and predict future performance of the model.

We incorporated both the depth/TRM ratio measured by MRI and clinical factors into a personalized nomogram for facilitating preoperative prediction of non-class-A healing in CSD patients. Multimarker analyses have been used in recent years for incorporating individual factors into marker panels [29].

All statistical analyses were performed by R software (version 3.3.2). The statistical significance levels were two-sided, with a P value of .05 or less.

Multivariable logistic regression analysis was used to assess the individualized prediction model with the following clinical candidate factors taken before surgery: the depth/ TRM ratio via MRI, number of menstruation days after C-section, WBC and fibrinogen. We built the final nomogram based on logistic regression analysis in the training cohort.

A calibration curve was plotted to evaluate the calibration of the nomogram using the Hosmer-Lemeshow test. A significant test statistic indicated that the prediction model did not calibrate perfectly [30]. Harrells C-index was computed to quantify the performance of the nomogram.

Internal validation was carried out using data from 167 patients.

Decision curve analysis was performed to determine the clinical usefulness of the nomogram by quantifying the net benefits at different threshold probabilities.

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Development and internal validation of a Nomogram for preoperative prediction of surgical treatment effect on cesarean section diverticulum - BMC...

Recommendation and review posted by Bethany Smith

For those who want to match their physical gender with what they feel is their true gender, Thailand is the place for Sex Reassignment Surgery (SRS) also known as Gender Reassignment Surgery, Sex Change Operation, and MtF Surgery, to name a few. So, what makes Thailand such an attractive destination for this type of procedure? In short, its because patients can get the most out of such surgeries in Thailand thanks to the number of highly trained surgeons, low-cost and quality health care, and decades of knowledge and experience in perfecting this procedure.

If youre considering SRS in Thailand, or you have a family member, a partner, or a friend who is wondering what is involved in the procedure, this guide should help to paint a clearer picture.

To undergo SRS is a huge, life-changing decision that should not be made lightly. It is a lengthy process that requires a lot of resilience and patience. Before the actual surgery, you will first need to live as a woman for at least a year and undertake hormone treatment to help reshape your body contour and stimulate the growth of a labia majora.

Heres a list of the required prerequisites that all surgeons will insist upon before considering your case:

The actual process usually involves a few procedures:

You may also choose other surgical procedures, such as a Tracheal Shave to remove your Adams apple, or a Buttock Augmentation to increase the volume of the buttocks. Since every patient is unique, the procedures involved in SRS can be performed based on your needs and budget.

The most important part of male-to-female surgery is the creation of the vagina. There are numerous surgical techniques to do this based on your preference. You can discuss with your surgeon which one is best for you. The other popular techniques are as follows:

1. SRS without vaginal depth

2. SRS with Penile Skin Inversion

3. SRS with Scrotal Skin Graft

4. SRS with Sigmoid Colon by Laparoscopic Technique

Caitlyn Jenner, Possibly the Most Famous Transgender Person Ever

Recovery after surgery will be a long and painful process. It will also require several follow up procedures as well as constant monitoring so you will have to stay a little bit longer at the hospital until you are fully ready to be discharged. Generally, allow for a minimum of 3 weeks stay in Thailand or the country of your choice area after your surgery. Most people are able to return to work in about 4-6 weeks after a sex change operation. Furthermore, you can resume strenuous work and exercise in about 6-8 weeks. It is vital that you strictly follow all medication instructions during your recovery period.

Social support is very important before and after the surgery, especially the support that comes from your family and loved ones. You have to be socially and emotionally stable before you undergo the operation. This is why it is required that you have proper counseling to help you with your emotional wellbeing. You have to prepare yourself mentally, before, during and after transition because it can be quite overwhelming and stressful.

It is also important that you maintain regular check-ups with your local Doctor to monitor the progress of your healing and avoid such complications.

The success rate for a sex change is very high, given our technological advancements. Gender reassignment surgery from male to female has a higher success rate than female to male; this is why more male transgender opts for a sex change.

However, given the nature and complexities of this type of surgery, you also have to be aware of its complications:

Possible side effects may also include:

SRS can be very expensive, especially since it is difficult to get this type of surgery in many countries. One reason why Thailand is popular with those who want to change their sexual identity is that the country offers more affordable fees. Many patients come from the United States because the US has the most expensive male-to-female SRS prices in the world.

The prices range from $25,000 to $30,000 for just the reconstruction of the genitals alone. If you want to add breast augmentation and voice feminisation surgery, you can expect to pay more than $50,000. Additionally, some clinics in the US dont include consultation fees in their prices, so you need to pay at least $50-100 for every consultation.

In general, SRS in Thailand costs around a third to half of what it can cost in the United States. For the reconstruction of the genitals in Thailand, you can expect to pay between $8,400 to $13,700 depending on which technique you choose.

Breast augmentation costs approximately $4,100 to $6,170 and Voice Feminisation Surgery costs between $3,590 to $7,180. In total, you will need to pay around $16,090 to $27,050 in Thailand for the complete procedure. These prices can also include packages, such as hospitalization accommodation, post-operative care, consultation fee, post-operative care, medications, and transportation.

The low-cost healthcare in Thailand does not mean low-quality treatment. In fact, Thailand is extremely popular among medical tourists because the country is known to have high-quality healthcare. Numerous medical centers in Thailand are accredited by prestigious international organizations, such as the Joint Commission International (JCI). The country has come a long way since its first Sex Reassignment Surgery in 1975, with many surgeons specialising in SRS for years, some even have over 20 years of experience. With their skills and experience, the surgeons and clinics can give patients the proper care they need and guarantee the best possible result.

Since there are many medical centres in the country that offer Male to Female SRS, it is understandable that some will better than others. To avoid disappointment, do your research, read reviews, find out about the clinics accreditation, and ask for your surgeons certifications. Better still, seek out the services of a dedicated Medical Tourism Facilitator like MyMediTravel who will guide you through the whole process and find you the best possible surgeon/clinic/hospital available and within your budget.

Continue reading here:
Chinese Medical Tourists visiting Thailand set to exceed 1 million by 2020 - The Thaiger

Recommendation and review posted by Bethany Smith

Addison disease occurs due to the injury of the adrenal cortex which causes insufficient generation of the hormone aldosterone and cortisol.Indications of Addisons disease are known as primary adrenal insufficiency, resulting from insufficient production of two hormones cortisol and aldosterone.

Treatment options for Addisons disease include many medications, usually in the form of tablets, depending on the specific hormones that the body is missing.

The drugs required to effectively treat Addisons depends on the hormones that are no longer being effectively produced in the adrenal glands.

Access Report Details at: https://www.themarketreports.com/report/global-addison-disease-testing-market-research-report

The global Addison Disease Testing market is valued at xx million US$ in 2018 is expected to reach xx million US$ by the end of 2025, growing at a CAGR of xx% during 2019-2025.

This report focuses on Addison Disease Testing volume and value at global level, regional level and company level. From a global perspective, this report represents overall Addison Disease Testing market size by analyzing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, China and Japan.

Key companies profiled in Addison Disease Testing Market report are Nhs.Uk, Mayo Clinic, Vca Animal Hospital, Niddk, Cleveland Clinic, Webmd, Bmj Best Practice, National Organization For Rare Disorders, Core Diagnostics Private Limited, Laboratory Corporation Of America Holdings, Sonora Quest Laboratoriesand more in term of company basic information, Product Introduction, Application, Specification, Production, Revenue, Price and Gross Margin (2014-2019), etc.

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Table of Content

1 Addison Disease Testing Market Overview

2 Global Addison Disease Testing Market Competition by Manufacturers

3 Global Addison Disease Testing Production Market Share by Regions

4 Global Addison Disease Testing Consumption by Regions

5 Global Addison Disease Testing Production, Revenue, Price Trend by Type

6 Global Addison Disease Testing Market Analysis by Applications

7 Company Profiles and Key Figures in Addison Disease Testing Business

8 Addison Disease Testing Manufacturing Cost Analysis

9 Marketing Channel, Distributors and Customers

10 Market Dynamics

11 Global Addison Disease Testing Market Forecast

12 Research Findings and Conclusion

13 Methodology and Data Source

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Global Addison Disease Testing Market: What it got next? Find out with the latest research available at 'The Market Reports' - Market Research...

Recommendation and review posted by Bethany Smith

Results

Inter-breed continental (A. Ivory, Perthshire) Senior: Sup., A. and J. Gammie, Westpit Orlando (Limousin); res., A. Hornall, Falleninch Obby (Charolais); Junior: sup., R. and A. Crockett, Bacardi Orleans (Salers); res., AJR Farms, Newlogie PrincessLaika (Charolais).

Inter-breed native (A. Gall, Lockerbie) Senior: Sup., T. McMillan, Eskechraggan Masterstroke (Beef Shorthorn); res., J. and C. McKenchnie, Harry 2 of Gartocharn (Highland); Junior: sup., N. Wattie, Tonley Lady Heather (Aberdeen-Angus); res., T. and D. Harrison, Moralee 1 Katy-Perry KS 58 (Hereford).

Aberdeen-Angus (R. Clarke, Ipswich) Senior: sup. and male, Firm of G. Gray, Ettrick Gladiator U218; res. and fem., R. and C. Rettie, Retties Elixir U032; res. male, R. and C. Rettie, Retties Lionheart U037; res. fem., Brailes Livestock, Brailes Miss Ellie U036; Junior: sup. and fem., N. Wattie, Tonley Lady Heather; res. and res. fem., H.W. Sclater, Deveron Kleo V647; male, S. Dick, Stephick Ezra V561; res. male, J.R. Galloway, Cardona Exchequer V113.

Beef Shorthorn (D. Anderson, Elgin) Senior: sup. and male, T. McMillan, Eskechraggan Masterstroke; res. and fem., D.D. McDowell, Castlemount Matrix Matilda; res. male, S. G. Mair and Sons, Muiresk Messiah; res. fem., D. Welsh, Westbroad Rosette 9; Junior: sup. and male, S. G. Mair and Sons, Muiresk Northern Dancer; res. and fem., J. and G. Ramsay, Millerston Irania Nutella; res. male, D. Welsh, Westbroad Nadal; res. fem., J. and G. Ramsay, Millerston Irania Novelty.

British Blue (R. Pattinson, Cumbria) Senior: sup. and male, K. Blackwood and D. Davidson, Blackstane Notorious; res. and res. male, K. Watret, Solway View Niko; fem., K. Watret, Solway View Netty; res. fem., A. and C.S. Comrie, Stonebyres Nymph; Junior: sup. and male, K. Watret, Solway View Odin; res. and fem., J. Hyslop, Netherton Ofilia; res. male, D. Saunders, Maidenlands Orion; res. fem., D. Saunders, Maidenlands Orla.

Charolais (K. Malone, Fife) Senior: sup. and male, A. Hornall, Falleninch Obby; res. and res. male, R.A. Milne and Sons, Elgin Obama; fem., R. N. Barclay, Harestone Odena; res. fem., R.A. Milne and Sons, Elgin Olwen; Junior: sup. and fem., AJR Farms, Newlogie PrincessLaika; res. and male, Brailes Livestock, Bassett Piper; res. fem., J. Muirhead, Firhills Polly; res. male, AJR Farms, Newlogie PrinceNobel.

Commercial (H. Dunlop, Ayrshire) Senior: sup. and male, B. Duffton and R. Stuart, Dirty Dancer (Limousin cross); res. and fem., A. and E. Vance, The Governess (Limousin cross); res. male, H. Thorn, Oreo (British Blue cross); res. fem., R. Wallace, Crunchie (Limousin cross); Junior: sup. and fem., J.M. Parker, Sweet Pea (British Blue cross); res. and res. fem., M. Kay, Sunday (Limousin cross); male, W. Robertson and Son, Bugsy (Limousin cross); res. male, A. Morton, Kygo (Limousin cross).

Hereford (R. Clarke) Senior: sup. and fem., G. and S. Harvey, Harveybros 1 Crocus; res. and male, B. Birch, Sky High 1 Shawshank Redemption; res. fem., T. and D. Harrison, Moralee 1 Kylie KS S3; res. male, G. and S. Harvey, Harveybros 1 Stan-The-Man; Junior: sup. and fem., T. and D. Harrison, Moralee 1 Katy-Perry KS 58; res. and res. fem., T. and D. Harrison, Moralee 1 Pippa KS 311; male, J.M. Cant and Partners, Panmure 1 Schweppes.

Highland (D. Dempster, Crieff) Senior: Sup. and male, J. and C. McKenchnie, Harry 2 of Gartocharn; res. and res. male, G, Hyslop, Eion Mhor 30 of Mottistone; fem., R. Fletcher and S. Gibson, Tiree of Craigleak; res. fem., Glasgow City Council, Siusan Ruadh 62 of Pollok; Junior: sup. and fem., L. Fotheringham, Caleigh of Cairncross; res. and male. H. Irvine, Raonull Dubh of Craighluscar; res. fem., S. and E. Haley, Sineag Dubh of Seam; res. male, I. W. Adams, Rob Ruidh of Brathens.

Limousin (M. Massie, Ellon) Senior: sup. and male, A. and J. Gammie, Westpit Orlando; res. and res. male, A. and J. Gammie, Westpit Oasis; fem., A.W. Jenkinson Farms, Whinfellpark Onita; res. fem., D. and L. Graham, Burnbank October; Junior: sup. and male, T. Illingworth, Eagleside Prometheus; res. and res. male, D. McBeath and S.J. Jessop, Springsett President; fem., Crawford Brothers, Rathkeeland Phoenix; res. fem., S. and H. Illingworth, Glenrock Pocahontas.

Salers (I. Livesey, Melrose) Senior: sup. and male, R. and A. Crockett, Bacardi Nevis; res. and fem., Rednock Estate, Rednock Myrrh; res. male, Rednock Estate, Rednock Nick; res. fem., C. Mcclymont, Cuil Nice; Junior: sup. and male, R. and A. Crockett, Bacardi Orleans; res. and fem., Farmstock Genetics, Cumbrian Hyacinth 1049 Poll; res. male, Farmstock Genetics, Cumbrian Olympia Poll; res. fem., R. and A. Crockett, Bacardi Octavia.

Simmental (S. Key, Norwich) Senior: sup. and fem., L.D. Quarm, Annick Trixbelle 24; res. and res. fem., Barlow Brothers, Denizes Daffoldil; male, G. Patterson, Aultmore Jack Flash; res. male, J. E. Dyet, Merkland Jimmy; Junior: sup. and fem., W.S. Stronach, Islaview Kenya; res. and male, L.D. Quarm, Annick Klondyke; res. fem., A.J. Wilson, Cairnview Tilly 7; res. male, Barlow Brothers, Denizes Kylian.

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Stars of the Future draws in quality entries - FG Insight

Recommendation and review posted by Bethany Smith

Dawn Covino was eager to use the genetic testing service 23andMe to find out more about her family history and that of her twin son and daughter she adopted from Kazakhstan in 2007.

She submitted DNA for herself and the children in 2011, and learned more about herself than she ever imagined.

I sent it in for the kids and I said, I'm just going to do it on myself to see if it's accurate, see if it can tell me that I'm half Polish, said Covino, now 46 and living in Suffolk County.

I get an email back: Something's wrong with your sample. You listed that you're female, but you're coming up with XY male chromosomes, she said.

And I'm like, what? That's weird.

Covino sent in another sample and then got a phone call from a geneticist working for 23andMe.

She asked me a few questions and she said, I think that you have AIS syndrome.

The results confirmed Covino was intersex a revelation that she said both made her head spin andansweredquestions shes had all her life.

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Intersex is defined as people with sex characteristics that may not line up with what is considered binary male or female bodies. These variations can appear in chromosomes, genitals or internal organs, and can be identified at birth, during puberty, or even much later in life. Intersex Day of Remembrance, also known as Intersex Solidarity Day, is on Nov. 8 to raise awareness about the issues faced by the intersex community.

You think you know yourself, right? said Covino, who was 38 at the time. It also gave me a sense of relief. I was like, 'wow, there's a name to this.' All this time, I thought I was the only one and now maybe I'm not.

Who am I?

Covino learned from genetic testing she has a form of androgen insensitivity syndrome, or AIS, which falls under the intersex umbrella. It occurs when babies are born with testes and XY chromosomes, typically found in what is considered a binary male body. However, theirbodies dont respond to hormones such as testosterone (also called androgens). According to the U.S. National Library of Medicine, AIS affects sexual development before birth and during puberty.

Covino said when she was 15, she noticed she wasnt developing like a normal teenage girl. She was scared and confused, and felt like she couldnt ask questions of her parents and doctors. Covino said she underwent surgery to remove her undescended testes, but didnt know the specific nature of the procedure at the time.

I think now the medical community understands a little bit more, but back then, the standard practice was to just remove them, Covino said.

She said her doctor told her that she wouldnt be able to conceive children. However, they didn't give me a name to it.

I felt like a freak. I felt like there was something wrong with me. I felt different, I felt like my body was different, and it was really hard. I went through depression and anxiety.

Covino, who grew up in Ronkonkoma, saidhigh school was especially difficult. I was bullied because I had low self-esteem when I was little, and I think it all ties in. She said that knowing she was different from her peers became the focal point of her life.

Her mind was full of jumbled thoughts, among them, Am I ever going to get married? Is a man ever going to want me?

Covino is now happily married, and has found the intersex community.

Defining intersex

The I in intersex is part of the LGBTQIA+ acronym with the other letters standing for lesbian, gay, bisexual, transgender, questioning/queer and asexual. When people learn about intersex, the conversation is often centered on surgery and peppered with medical terminology.

Hans Lindahl of San Francisco is hoping to broaden the discussion. Lindahl, who identifies as intersex, is the director of communications and outreach for interACT. The national organization advocates for intersex youth in law and policy, does media consultations and raises awareness. Additionally, interACT has a youth program that provides resources to young intersex people.

It's definitely not common for intersex people, even now, to hear the word intersex from doctors or to come across that word even when they're starting to understand how their own body is different, Lindahl said.

And I think that that is probably not a coincidence. Intersex is a fairly recent term and it also speaks to community, and it's a term that people have taken on to find each other and to reclaim their bodies from being completely medically controlled.

Intersex surgery, such as the removal of ovaries or testes, is controversial. Many intersex advocates say these surgeries are mostly for aesthetic purposes and can be postponed or not undergone at all. There is also the matter of consent the surgeries are sometimes done on babies and can lead to more surgeries, struggles with gender identity and mental health issues.

Many doctors believe these surgeries are medically necessary and that the procedures have evolved over the years. Dr. Lane Palmer, the chief of pediatric urology for Northwell Health who published an article on the push to ban intersex medical intervention, said that hospitals such as Cohen Childrens Medical Center (which is affiliated with Northwell) use a multidisciplinary approach with intersex individuals.

The issues are very complex not only are they physical, but they're also psychological and emotional and social, he said. At Cohen's, there's a multidisciplinary group that consists of pediatric urologists, endocrinologists, psychiatrists, social work, genetics.

They are each unique, so they hear all of the options.

This month, a bill was introduced in the New York City Council that seeks to inform parents of intersex children. It would raise awareness surrounding treatments that are medically unnecessary for infants born with intersex traits.

A State Senate bill in California is expected to be considered next year, under which doctors and parents would not be allowed to go forward with treatment or surgery on intersex minors unless its medically necessary, such as if a child were unable to urinate.Intersex advocates support the bill, while some doctors argue its too restrictive and interferes in a parents decision with their doctor.

Lindahl and Palmer agree that the best advice for an intersex person considering any option is to ask as many questions as possible.

On a local level, David Kilmnick, president and chief executive of the LGBT Network on Long Island, said the organization provides intersex education and awareness as part of a larger program. The program is offered in schools, workplaces, and houses of worship, Kilmnick said.

I started this organization 26 years ago and in all of those 26 years, the number of folks who identify as intersex is small compared to those who identify as LGBT, he said.

Who I am

When Covino started doing research about being intersex, she joined a support group for those with AIS and has attended their annual summer conferences.

It's definitely nice connecting with other people because it's rare, but it's not as rare as people think, Covino said. They say that if you know someone who's a natural redhead, then you probably know someone who's intersex, but you just don't know because you don't see it.

Estimates on how many people are intersex vary, in part because the definition of intersex is so wide-ranging. There are more than 30 specific intersex variations, according to interACT. Some doctors, such as Palmer, say that 1 in 2,000 people are born with intersex traits in the United States. Lindahl and other advocates say there really isnt an exact number.

Covino said she doesnt personally know anyone on Long Island who identifies as intersex, but formed "immediate connections" when she's met up with people from her support group who live elsewhere.

She and her husband, Robert Covino, attended SUNY Oswego at the same time but didnt meet until years later through mutual friends on a cruise. Covino said she had been looking forward to the prospect of adoption, and Robert was, too. They spent months and months filling out all of the paperwork together, and the waiting game was horrible, she said.

Finally, their opportunity came. Or rather, opportunities.

We get the call [from the adoption service] and theyre like, Would you be interested in twins? And we were like, Oh, my God, of course. Yes.

Covino gets emotional when she talks about meeting her son and daughter for the first time.

I finally had them in my arms, she said. It was right before their first birthday when we got them. It was very special.

When she first learned about AIS, Covino struggled with how she would tell her husband. One night when they were out to dinner, she said, I have to tell you something.

Then, she just told him. He froze.

Hes like, Oh, I thought you were telling me you had cancer, she said, laughing. He was relieved. To me it was this huge deal and he was just like, OK.

Now, Covino helps children and young adults with disabilities overcome challenges as a psychologist at Nassau BOCES. I just knew that I always wanted to work with children, she said.

Covino said she hopes that students, including her own kids, start to learn about the intersex community in schools, and believes it should be included in health curriculum.

It should be talked about, because you shouldn't be made to feel like there's something wrong with you, she said. This is just a part of life. And Im at a point now in my life where I'm just like, all right, this is me.

This is who I am. It doesn't make me who I am. There's so many different parts to me.

Rachel Weiss joined Newsday in 2016. She writes and produces local content for newsday.com, including stories on religion and colorful characters from Long Island.

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She sent 23andMe her DNA. They told her she's intersex. - Newsday

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On an August day in Washington state, fields of crops stretch like seas until they bump up against 100-foot-high pines. Cars are rolling over the High Bridge as locals swim in the coursing stream below. Thirty years ago, this serene scene was likely the site of a grisly crime part of a double murder that would make legal history.

Under the bridge, on Thanksgiving Day in 1987, pheasant hunters found the body of Jay Cook. The 20-year-old had been beaten around the head and strangled with twine tied to dog collars. A pack of Camel Lights had been stuffed down his throat.

Two days earlier, a passerby, more than an hours drive away had also found a body. It was Cooks girlfriend 18-year-old Tanya Van Cuylenborg.

Thursday on the PBS NewsHour, William Brangham meets people who have taken DNA tests and as a result been inadvertently involved in murder investigations because of genetic genealogy. Check your local listings for the time, and watch Part 1 here.

Tanyas body was found mostly nude on the side of the road, said James Scharf, who was a Snohomish County patrolman at the time. Shed been raped and shed been shot in the head probably right there on the side of the road.

The couple had come down from Victoria, Canada, to pick up machine parts for Cooks dad, who owned a furnace company. The couple turned the errand into a road trip through Seattle, camping out in Cooks family van, a bronze Ford.

The killer probably parked under a bridge that he knew was a good out-of-the-way place where nobody would see the van, Scharf told the PBS NewsHour. That is where he would have killed Jay, and he would have come back and try to set Tanya at ease before killing her, too.

While on a road trip in 1987, Jay Cook and Tanya Van Cuylenborg were murdered, their bodies found nearly 80 miles apart. The case remained unsolved for 32 years, until genetic genealogy emerged. This forensic technique relies on at-home DNA tests and public databases to track down violent criminals. Photo courtesy of James Scharf

The van was found in a parking lot nearby Van Cuylenborgs corpse. There was semen on her body, as well as on the hem of her pants, which were left inside the van.

And thats where the trail went cold for three decades. No eyewitnesses. No concrete leads.

At the time, there was no DNA database anywhere in the country to compare the semen and search for a potential culprit. But last year Scharf, now a detective in the Major Crimes Unit, heard about a forensic tool called genetic genealogy.

Without genetic genealogy, this case never would have been solved, Scharf said. Thats how powerful genetic genealogy is in solving crimes.

Genetic or forensic genealogy combines direct-to-consumer DNA tests like those purchased through 23andMe or Ancestry.com with the age-old hobby of tracing a family tree with public records, such as birth certificates and land deeds.

The technique relies on the simple principle that, if you go back far enough in history, everyone is related, and therefore has thousands of relatives. Assuming that an average family has 2 to 3 kids, then a typical person would statistically speaking have nearly 200 third cousins, 950 fourth cousins and 4,700 fifth cousins.

Assuming that an average family has 2 to 3 kids, then a typical person would statistically speaking have nearly 200 third cousins, 950 fourth cousins and 4,700 fifth cousins. Image by PBS NewsHour

If a genealogist can find a cousin of an unknown suspect who has left behind DNA at a crime scene, then they can use old school family trees sometimes literally drawn on paper or white boards to track down the perp.

Thats how the Golden State Killer and about 70 other suspects behind brutal cold cases rapes, murders and assaults have been caught since April 2018.

In June, a Snohomish County jury convicted 56-year-old William Earl Talbott II for the first-degree murder of Cook and Van Cuylenborg. The episode is historic because Talbotts trial and conviction were the first made through genetic genealogy.

From a law enforcement perspective, the case for using genetic genealogy is strong. But experts are also flagging concerns about what the method means for peoples legal and DNA privacy.

Big companies like 23andMe, Ancestry.com and MyHeritage dont allow police to rifle through their records, at least not without a subpoena or search warrant. So genetic genealogy for cases like Talbotts rely on people who willingly upload their DNA profiles to more public databases raising the specter of personal health information being exposed.

Genetic genealogy in truth, any forensics dependent on DNA can fall prey to the same human biases that plague other aspects of law enforcement. Close relatives or even non-relatives can be accused of the crime if care is not taken with how the genetic genealogy is interpreted.

It happened to Michael Usry.

Back in 2014, Usry, a filmmaker based in New Orleans, was visiting his parents house when he received a phone call from the police. Usry said the officers wanted to check his vehicle because it matched the description of a car involved in a hit-and-run. The cops swung by and he agreed to head down to the station.

Michael Usry, a filmmaker based in New Orleans, was wrongly accused of a murder, due to a false lead suggested by one form of genetic genealogy. Photo by William Brangham/ PBS NewsHour

When I was walking out the door with them, I turned to the sergeant who ended up being the sergeant of Idaho Falls Police Department and I said, So this is about a hit and run? Usry said. And he goes, Well, actually Mr. Usry, we want to talk to you about some other things as well.

The other thing was Angie Dodge, a young woman who was raped and murdered in Idaho in 1996.

But genetic genealogy, which pointed to Usry, is not foolproof. Heres how it can go wrong.

There are three major types of genetic genealogy mtDNA, Y-DNA and autosomal depending on what type of DNA is used and what the search entails. MtDNA genealogy relies on mitochondrial DNA inherited from mothers, so its useful for tracing maternal heritage. On the flipside, Y-DNA refers to the Y-chromosome acquired by biological males from their fathers so it can track paternal ancestors.

But when people mention genetic genealogy used in cases like the Golden State Killer or William Earl Talbott II, what they mean is a search thats dependent on autosomal DNA.

Everyones DNA biography genome is essentially the same, containing more than 3 billion letters in an order that is 99.6 to 99.8% identical.

Pretty much every human possesses 23 pairs of chromosomes, and autosomal DNA is the genetic material packed into 22 of them (the last pair consists of the sex chromosomes, which well discuss in a second).

At the end of 2009, 23andMe introduced the first test where we could use autosomal DNA for genealogy, said CeCe Moore, a genetic genealogist with Parabon Labs who helped Scharf pinpoint William Earl Talbott II. Thats the type of DNA that you inherit from all of your ancestral lines and it was immediately obvious to me that the potential for discovery was almost unlimited.

Thats because those DNA tests read all of a persons chromosomes like a biography. Everyones biography DNA code or genome is essentially the same, containing more than 3 billion letters in an order that is 99.6 to 99.8% identical.

But when a person sends a saliva sample to 23andMe or Ancestry.com, they receive back a profile that is mostly focused on 600,000 to 700,000 letters found in those 22 autosomal chromosomes. Those tests reveal subtle differences in those letters called SNPs that can explain why people have different hair colors and health conditions. Autosomal SNPs can also show who is related. Everyone carries about 12.5 percent of their great-grandparents autosomal DNA.

Were looking for people that share long stretches of identical DNA. The more shared DNA, the closer that ancestor is in time, Moore said. If you share about 3 percent of your DNA with someone, then youre most likely second cousins. If you share about 6 percent, then youre most likely first cousins once removed. If you share about 12 percent, then youre most likely first cousins.

CeCe Moore is one of the pioneers of using genetic genealogy for forensics. She said the process of tracking down a suspect can take anywhere from a few hours to months, depending on the size of the family and the available public records. Image by Michael Werner

WATCH: CeCe Moore explains how at-home DNA tests and genetic genealogy helped solve a 30-year-old murder

After Moore finds a cousin or cousins who match a suspects DNA, she will hunt down all the public records she can find related to their family birth certificates, death certificates, family connections on social media. That allows her to reverse engineer a family tree building up to a common ancestor, like a great-grandparent.

Shell then flip the process researching so she can build and climb down the family tree until she finds the subsection of the family that contains her unknown suspect. Moore said its impossible to predict how long it will take to zero in on a potential suspect. Depending on the size of the family, the process can take months and involve looking up thousands of people.

The William Earl Talbot II case was the fastest. I zeroed in on him after only two hours, said Moore.

But none of this can happen without the right DNA database.

One common misperception about the rise of forensic genealogy is that 23andMe, Ancestry.com and other big direct-to-consumer companies are somehow involved that those companies have ratted out their users by allowing law enforcement to dig through their DNA records.

The opposite is true. Most wont work with law enforcement without a court order. Even if they did, a genealogy search would probably strike out.

Thats because so many of these companies exist. If you subscribe to 23andMe and commit a crime, theres no guarantee that one of your cousins has done the same. Maybe they used Ancestry.com, MyHeritage or the dozens of other companies on the market.

Thats why GEDMatch was created to serve as a meeting space for people interested in their ancestry, but who have struggled to find family members through their testing service of choice

We never advertised and promoted. This strictly grew by word of mouth and social media, Curtis Rogers, one of GEDMatchs founders, told NewsHour. GEDMatch headquarters is in Lake Worth, Florida, mere miles from the ocean and President Donald Trumps Mar-a-Lago resort. The yellow, beachy bungalow with a giant red rosebush out front doesnt scream this is a digital hub of 1.25 million DNA profiles.

Curtis Rogers, a co-founder of GEDMatch, outside the companys homebase in Florida. Photo by William Brangham/ PBS NewsHour

Rogers, an 80-year-old, semi-retired businessman, co-founded GEDMatch because of his fascination with his ancestry that started as a teenager after his grandfathers brother asked him to fill out a genealogy form.

Thats how we used to do things in the old days, Rogers said. Slow-mail a form to fill out your parents names, when they were born, when your siblings were born, that type of thing.

Fast-forward to the internet era, when Rogers was volunteering for an ancestry website called FamilyTreeDNA. The company asked him to take charge of a surname project that involved tracing the lineages of people named Rogers. Were sending emails to people, and it would take hours trying to figure out who the common ancestors were, he said.

At the time, Rogers had a small personal website and a partner John Olson who was good with computers. One day, Rogers asked Olson if the latter could put together an algorithm for matching family trees via computers, rather than doing all the manual back and forth.

Curtis Rogers, co-founder of GEDMatch

GEDMatch launched in 2010, allowing people to download their raw, autosomal DNA profiles from companies like 23andMe and then upload them into a public place. GEDMatch users can use an alias with their accounts, and a search will only yield the account name and contact info.

People think that were showing DNA in our site. We dont show anyones DNA. We show matches, Rogers said.

That is great for genealogy hobbyists, but also for law enforcement who have limited means of tracing family ties through DNA.

In 1990, Virginia became the first state to store the DNA records of convicted felons in a database a move that would be replicated by the other 49 states before the end of the millennia. The Federal Bureau of Investigation eventually united all of those databases, in 1997, into one national network called the Combined DNA Index System, or CODIS.

But CODIS has privacy limitations that inherently prevent its use with genetic genealogy. Whereas a 23andMe-style DNA profile contains info on up to 700,000 spots in a DNA code, a CODIS profile has 20. Those 20 spots are in special zones called short tandem repeats parts of the genome that dont define a persons health status or appearance. Just try writing a persons biography with only 20 hard-to-decipher letters. Hence the allure of GEDMatch.

You dont want to get caught, dont be a criminal, said Curtis Rogers, a co-founder of GEDMatch, inside the companys headquarters. Photo by William Brangham/ PBS NewsHour

But the fact that law enforcement was actually using GEDMatch? It was a shock to me, Rogers said. He and Olson didnt learn that their services were being used for culprits until investigators in the Golden State Killer case announced on April 25, 2018, that they had called on the website to apprehend Joseph James DeAngelo.

[I] came to the office the next day and there were reporters, Rogers said. They drove from MiamiThere were satellite trucks out here in this little narrow street; really upset the neighborhood.

Rogers said he was initially confused, upset and worried that the investigators had violated his users privacy.

He said it took him about two weeks to really figure out how his site was being used and that it was not a violation of personal data.

He said their terms of service had always warned that information might be used for purposes outside of genealogy. After the Golden State Killer episode, they updated the terms to permit law enforcement searches in the cases of violent crime, which they defined as rapes and murders. And he disagrees with critics who claim such searches are detrimental.

If they could see some of the emails from these families that have had some closure, I cant imagine that anyone would say its the wrong thing to do, Rogers said, adding that, if you dont want to get caught, dont be a criminal.

When Michael Usry, the filmmaker from New Orleans, was 19, he had traveled through Idaho Falls on a couple occasions around the same time as Angie Dodges murder once for a Mormon mission trip and another time for a ski vacation in Utah. But in 2014, detectives were interested in Usry because of his dads DNA.

Sixteen years ago, Usrys father had been convinced to submit a cheek swab to the Sorenson Database, as part of a genealogy project in which participation was encouraged by the Mormon church. This DNA database was public, but only contained profiles of Y-chromosomes and mitochondrial DNA thus, it could only trace paternal or maternal heritage.

Michael Usry said police officers should be allowed to use the tools that theyre given to catch criminals, but given his experience, he worries about the possible misuse of powerful DNA techniques like genetic genealogy. Photo by William Brangham/ PBS NewsHour

But police in Idaho Falls which has a large Mormon population saw an opening. When they ran semen from Dodges murder scene through the database, they found a close match 34 of 35 letters belonged to Usrys father.

They immediately eliminated my dad because he was too old, Usry said.

But when they started doing research, they saw my short film, said Usry, who had co-produced a slasher film called Murderabilia, which includes the murder of a young girl. Usry said police grilled him for a couple hours before asking him for a cheek swab. He goes, Well, do you see this warrant right here? Its signed by this judge and that means that you have to do this for us, right here and right now.

Usry was released, but he said he spent a worry-filled month before the police called to say his DNA wasnt a match.

Theres a long and documented history of the misuse of forensic evidence and criminal justice, said Erin Murphy, a law professor at New York University. Its an important point to remember because DNA, too, can be misused.

Heres why that also applies to genetic genealogy.

Even though autosomal genealogy with its 700,000 letters offers a much more specific portrait of a person, it can still lead to false identifications. Ancestry tests can be misinterpreted, and a direct-to-consumer DNA profile can contain errors typos in the book. A small study in 2018 found up to 40 percent of the SNPs identified in DNA profile might be false positives, a result mirrored by a second study published this June.

Moreover, autosomal genealogy cannot distinguish between siblings because their DNA is too similar. If your brother or sister commits a crime, this brand of genetic genealogy can lead detectives to surveil you.

Thats because genetic genealogy is only useful for generating a paper lead a family tree.

Benjamin Berkman, deputy director of bioethics at the National Human Genome Research Institute

Because Ive worked in unknown parentage for so long, Im acutely aware that sometimes peoples family trees are not what they appear on paper, said CeCe Moore, referring to confounding factors like adoption. She said she tries to emphasize these caveats possible siblings that cant be found through public records to law enforcement.

Thats why detectives still need a direct piece of a persons DNA to confirm a match. In the Cook and Van Cuylenborg investigation, Scharfs team surveilled Talbott for weeks until he discarded a coffee cup with his saliva, and other genetic genealogy cases investigated by their unit have involved tracking siblings.

Benjamin Berkman, deputy director of bioethics at the National Human Genome Research Institute, said sibling surveillance or cases like Usrys may just be an unfortunate inconvenience of using a powerful tool.

If were weighing convicting someone whos committed a terrible crime against the idea that an innocent person might have to give a blood sample, that seems like a trade-off that most people would be willing to make, Berkman said.

He is more concerned about another technique that is rising alongside of genetic genealogy called DNA phenotyping. Investigators claim that it can guess the appearance eye color, hair color, skin color, face shape of a suspect or Jane Doe based purely on their DNA.

The science there is much less well-developed and we need to be very careful about relying on it to target people, Berkman said. There is a case in Germany where they thought that the DNA evidence from a murder scene pointed to a certain ethnic minority, and then [law enforcement] went and harassed that population.

After Michael Usry was cleared of any connection to Angie Dodges murder, he became acquainted with her mother, Carol. Usry is working on a documentary about their experience. Genetic genealogy would ultimately lead officers to the alleged culprit: Brian Leigh Dripps Sr. Photo by William Brangham/ PBS NewsHour

It turned out the sample was contaminated, and regardless, the accuracy of DNA phenotyping varies wildly depending on the trait. For example, it can predict brown and blue eyes with 90 percent accuracy, but it cannot pinpoint other colors like gray, said Amade Mcharek, an anthropologist at the University of Amsterdam who specializes in forensics and race.

For skin color, dark brown is very precise with DNA phenotyping; very pale is very precise. Everything in between is still not that precise, Mcharek added. Likewise, only 40 to 45 percent of facial structure can be precisely judged by DNA phenotyping. Mcharek said much of DNA phenotyping still relies on human interpretation, which creates an opportunity for bias.

Given these pitfalls in genetic genealogy and phenotyping, Berkman, Mcharek and Moore said everyone involved in these emerging arenas of DNA forensics from detectives to genealogists need to follow the highest standards when tracking down possible culprits.

Berkman added that police departments need to be more transparent about when and how theyre using genetic genealogy and other DNA information to prosecute someone.

I would worry a little bit if genetic information was the only thing leading to prosecutions, said Berkman. We still want investigators to have to build a traditional case for prosecution beyond just the genetic evidence.

William Brangham and Rhana Natour contributed to this report.

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Genetic genealogy can help solve cold cases. It can also accuse the wrong person. - PBS NewsHour

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Speaker Pelosi, Adam Schiff and their Democratic colleagues have spent countless hours and taxpayer dollars to find evidence that President Trump was involved in corruption. At the same time, Democrats refuse to even consider the fundamental issue at hand was President Trump right to question the activities of Hunter Biden in Ukraine?

Months ago, media reported Hunter Bidens shady business dealings. But, once impeachment began, the mainstream media moved to kill the story. Were told nothing to see there. Yet each week, new information continues to emerge demanding a full investigation of the facts.

We know that Hunter Biden essentially made his living as a high-powered lobbyist benefiting from his fathers career as a senator and vice president.

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When Joe was elected vice president, Hunter claimed to leave lobbying, but really he just shifted his game. He formed a series of companies with Christopher Heinz, the stepson of Foreign Affairs Committee chairman and later Secretary of State John Kerry. These kids, trading on their fathers names and political ties, made a pretty powerful combo.

As the New York Times reported, Biden and Heinz pursued multiple foreign business investments where connections implied political influence and protection.

These guys closed lucrative deals with China right after Hunter visited China on Air Force II with his father. Importantly, they were working in Ukraine while Joe was leading Ukrainian policy for the U.S to fight corruption.

Ukraine is known for its corruption. A small group of oligarchs holds most political power. Hunter and his company went to work for one of these guys and his notoriously corrupt energy company, Burisma Holdings. Hunter was paid up to $50,000 a month to sit on its board.

We know Hunter knew nothing about energy or Ukraine. But, when youre dealing with a corrupt country like Ukraine, and the son of the vice president of the United States is involved in a corrupt company, that sends a signal to government officials when considering pursuing investigations.

At the same time, Vice President Biden was threatening to withhold aid to Ukraine unless they fired the prosecutor allegedly looking into Burisma. Senior State Department officials raised concerns about Hunter to the vice president. Yet, the arrangement continued until recently.

The bottom line is that there are serious allegations here, they directly relate to impeachment, and Congress needs to find out what happened. In fact, I introduced H.Res. 631 directing the relevant committees to investigate alleged Biden corruption. Despite having a substantial number of cosponsors, my resolution has been bottled up by Speaker Pelosi.

Last week, Republicans on the Intelligence Committee echoed my resolution, requesting that if Hunter Biden is going to be the basis for impeachment, Congress should get his testimony in the impeachment inquiry. But, Democrats have signaled they wont allow it. My question is, why?

We know the answer this is a partisan witch hunt against President Trump. President Trump never once demanded a quid pro quo from President Zelenksy. You can read the transcript yourself. While the Democrats and their allies in the press have trashed President Trump for raising Burisma and Ukraines role in the 2016 elections, those are serious issues worthy of investigation.

I am proud to be a leader in the pressure campaign to expose the hypocrisy of the Democrats sham process. And I will continue leading the fight to investigate the Bidens and expose real corruption that may exist. If Democrats are serious about exposing corruption, investigating Hunter Biden cannot be ignored.

One thing Ive learned is that you cant win a fight you dont join. When you fight, good things can happen. That is why I am going to keep fighting, to make sure the truth is out there.

U.S. Rep. Bradley Byrne is a Republican from Fairhope. He is a 2020 candidate for the U.S. Senate.

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For a long time, scientists have agreed that human life began in Africa. Just where in Africa has never been positively identified. A new study, led by Vanessa Hayes of the Garvan Institute of Medical Research in Sidney, Australia using mitochondrial DNA, claims to pinpoint the location to an area in Botswana, according to National Geographic.

Mitochondrial DNA is only passed down through the mother, and it is believed that all humans have a common ancestor a mitochondrial Eve that represents the closest maternal relative to modern homo sapiens. According to this study, there is a common single homeland where that mitochondrial DNA originated.

Location of Botswana in Africa. Image by TUBS CC by 3.0

The study is controversial among scientists. Evolutionary geneticist Mark Thomas, from the University College in London claims Hayes work is storytelling, but University of Hawaii at Manoa geneticist, Rebecca Cann, has called the study innovative as it uses many disciplines to find information. Cann agrees that even if the study has errors, it will open new avenues of exploration to either prove or disprove the research which may lead to new discoveries.

The conclusion of this study, found at Nature, states that southern Africa, specifically the MakgadikgadiOkavango palaeo-wetlands, commonly known as the Kalahari section of northern Botswana, is where the earliest modern human genetic relationships began, even though the oldest human bones found so far were in eastern Africa.

Location of the Kalahari desert in Botswana.

Two hundred thousand years ago, the now arid and salty location was covered in lush green plants in a wetland near what may have been the largest lake in Africa, and populations were steady. There were no huge growth spurts and no diseases or weather related emergencies to lower the population for seventy thousand years, but suddenly a change in human lineages indicated the beginnings of migrations due to the wetlands starting to dry up. Archeological evidence proves foraging for marine life up and down the south coast.

Bushmen of the Kalahari Desert in Botswana

According to Science, the mitochondrial DNA of two hundred living tribal hunter-gatherers from South Africa who dont usually have such tests done was collected and compared with a DNA bank of nearly one thousand other South Africans. The comparison indicated that the oldest known mitochondrial DNA lineage in living people is found in the Okavango palaeo-wetland. They also found that the particular DNAs origins are from about two hundred thousand years ago a number very close to previous estimates.

1892 image of the Bushmen of the Kalahari desert, Botswana

Another critic, an evolutionary geneticist from the University of Pennsylvania, Sarah Tishkoff, maintains that mitochondrial DNA traces only one genetic lineage passed from mothers to their children over time and these evolutionary mothers may have migrated to the Kalahari from elsewhere in Africa where the descendant line may have gone extinct. She believes that male Y chromosomes should have played a role in the tests as well, according to Science.

Hayes responds to the critics of her procedure by saying that most DNA is not stable during fetal development except for mitochondrial DNA. The male Y chromosome of the groups was no longer pure enough as men were more likely to have blended with other groups.

National Geographic reports that John Hawks, a paleoanthropologist at the University of Wisconsin-Madison agrees with the theory of a more mobile population that may not be the same people who were here hundreds of thousands of years back; he can agree with some of Hayes research, but he believes there is still much to be done before a solid conclusion can be made.

Most DNA researchers agree that everyone shares common ancestral mitochondrial DNA but it is such a small amount that some believe it is probably not possible to accurately pinpoint origins of where human life began. In the big scheme of things, DNA is a relatively new field of study and there are few definites. Yet this study cant be discounted and with further research could prove to be the actual location of human origins.

Related Article: Europes Oldest Human Fossil Found 210,000 Years Old

With computer modeling and better carbon dating methods, new discoveries about where human life began are happening every day. Some scientists are leaning in the direction of DNA that combined together from different places in Africa that evolved into our species rather than a single origin. Others dont believe that current science can find a single origin, if there is one, and scientists must modernize and broaden their approach. It appears that this question may be open for a while.

Originally posted here:
New Study Claims to Pinpoint Exact Location where Human Life Began - The Vintage News

Recommendation and review posted by Bethany Smith

Photo: Daniel Johnson

Published 11/12/2019 | Reading Time 7 min 43 sec

By Ethan Lipsitz, founder of Extremist Love

Heres the truth: White people will always be oppressors until we consciously take action towards equity and justice. This is painful to hear and challenging to fully understand when you have the privilege of being white, yet its truth is undeniable.

Right now, in America and across the world, oppressed people are confronting extreme political, economic and physical violence. This violence is so often at the hands of white cis-gendered, able-bodied men towards women, people of color, indigenous, non-binary, trans, immigrants, and disabled people. Although its not new, the number and intensity of violent confrontations are increasing and getting louder. Immense injustice was cultivated and nourished through our laws, our economies and our societies for generations; 2019 is a time of uprising that brings to surface those inequalities. These injustices have been built on the premise that white men are supreme to all others.

From what I can only perceive as the shame of confronting this reality and fear of losing power in the face of a changing power structure, I see too few white male cis-gendered peers joining the ranks of social actors advocating for change.

Yet, we must do so if we are to maintain any position of dignity and respect as the world evolves around us.

Over the last few years, the concept of Whiteness has become a growing part of my daily consciousness. As a white, cis-gendered man, I understand the gravity of acknowledging the privileges and power I have, and will continue to have, in this body. I also understand that simply being me without taking conscious actions towards equity and justice perpetuates the status quo of white supremacy.

This privilege is intimately linked to my choice to identify as a Love Extremist. The ease with which I can even call myself an extremist is intrinsically tied to my being white and not perceived as a physical threat. Then theres love. Im lucky that I felt I experienced and was modeled healthy love at a young age, which many people, regardless of age, sex, gender identity, and race, do not.

Since starting the Love Extremist movement, Ive used podcasting, salon conversations and pins to interrogate how we define love and extremism as a culture. Ive realized these definitions vary considerably. Often definitions of love are informed by ones privilege, upbringing, trauma and perspective.

Reading Bell Hooks All About Love and A Will To Change, I learned the deep ties between white supremacy, patriarchy and capitalism. Hooks posits that they are not three separate entities, but one overarching power structure that keeps us white men in control while limiting our capacity for living emotional, creative and loving lives. Thats right guys, we suffer from this system too. Even though we are oppressors, we are also oppressed by the expectations of dominance and toxic masculinity that permeate our culture.

The concept of Blackness was created by white Europeans at the end of the 1400s to classify darker skinned people for purposes of control in a racial caste system. Read more about that here. This early classification of black people effectively justified human slavery and denigrated the status of dark-skinned people, despite their incalculable contributions to our societies, civilizations and genetic human evolution as homo sapiens.

We can trace these early beginnings of systemic racial division to the inequities and injustices we see all around us today from our prison industrial complex to the quality of our drinking water.

As an entrepreneur, community leader and artist I am surrounded by white people, mostly white cis-gendered men, who are using the language doing the work to refer to our personal spiritual and emotional evolution. Its not enough. Not even close.

Were practicing meditation, going to therapy, leading and attending mens groups, going to Peru or Topanga Canyon to take plant medicine, attending Burning Man and dancing our faces off at sober and drug-infused dance parties around the world. We may be working on our relationships, studying intimacy and how to be better partners or learning about community leadership and management so we can manifest more abundance in our lives and work places.

While this personal and inter-relational work is great, Im afraid it falls short of what our culture needs to heal. To heal we must break out of our immediate, mostly white, cis, able-bodied, male-run communities and start building bridges into those we dont yet know. We must listen and learn (and learn to listen).

We must sit in discomfort as we begin to understand how our personal identity work and our privilege often comes at the expense of others who dont have it.

In waking up to my Whiteness, I accept my complacency and complicity in a system that oppresses people of color. And women. And all those who have been disempowered by our laws, economic structures and behaviors as a society. This awakening isnt about personal development, its not about leveling up or optimizing or improving my emotional intelligence. This is my work as a conscious human being, awareness is the bare minimum, its a requirement to exist in our rapidly changing world.

After awareness we can shift into action.

I am going through this process now, and its not easy. My discomfort grows every time I am being called out or when I experience one of my peers speak over a woman or person of color, we rush to share our views or experiences without even listening to them. Theres no mastery here, its a constant effort to do better.

We take our born privilege into circles where it is not welcome and offer our personal thoughts as a guise for productive action. This piece is a letter to myself and to those white, cis, able-bodied, male peers I share spaces with. Here are some suggestions for us to authentically evolve into ally-ship with those who we actively and unintentionally oppress.

Photo: Hadas

1) Diversify Your Communities: While its valuable to do personal and group work, if its in a homogenous environment of other men who generally look like you, change that.

If your mentor is a white man, seek someone else for advice. Invite folks who dont have the same set of economic, racial, able, sexual and gendered privileges as you into your space. Remember, if they show up, they are not tokens and should be treated as peers. If that feels uncomfortable, then youre moving in the right direction, get to know your discomfort and where it comes from.

Its essential to recognize your role as a white man is to empower others into spaces where they can be seen and heard. This is not about being a hero or collecting folks of color for some invisible scoreboard its about shifting the paradigms of society. We have so much to learn from other perspectives that are different from ours, and we have so much to offer once respect, trust and authentic communication has been established. We also do it because its the path towards a more just, equitable world.

2) Learn to Sit With Discomfort: When you or your culture are being questioned, its not the time to fume or defend, its not the time to turn off or run away, its time to sit, listen and learn. You want to get to your growth edge? Sit in discomfort for a while. Dont opt out because your privilege allows it.

Like an ice bath or a tough physical training, being in community where youre not in control can be hard. This is so important to do as our society evolves. If we are to continue to have any place leading our evolution into future generations, we must learn to build respect. That means listening actively to those who usually arent heard, that means being uncomfortable by keeping quiet in new spaces.

Remember, the personal discomfort (like throwing up in an ayahuasca ceremony) that comes from our own work in community can often be misconstrued as doing the work and in some ways it is. However, to make progress with facing your Whiteness, you must engage with the discomfort you feel in non-white spaces. You must learn to listen to and work alongside folks who dont share your race, worldview or economic background and treat them as peers, not support staff. This means extra work breaking beyond the circles you may normally engage with.

3) Ask For Permission when entering community spaces where you wouldnt usually go.

Being a white man means you are often seen as an oppressor. Showing up and listening is intrinsically changing that paradigm, nothing needs to be said, your body, open mind and attention do more work than your words and reasoning ever can.

Whether its a different political, racial or economic space than youre used to, its crucial to not only invite new folks into your spaces but to bring your body into diverse spaces when permitted. Again that may be uncomfortable and this isnt a call to go and speak up unless your voice is clearly welcomed into the circle.

Use your embodiment skills in being a present, listening body. Thats often a huge first step in building trust and connection with others. Again, dont show up anywhere where youre not welcomed, ensure your presence will be accepted and understand that simply being in the space may be triggering for some.

Photo: Daniel Johnson

4) Show Up With Love: If you come from love, bring it everywhere you go. Dont just share your love with those who look like you, offer it to those who dont. Love is listening, love is smiling when appropriate, love is putting your body in uncomfortable spaces.

Its so important to recognize that love is not pushing ourselves on others. As men, we were brought up to be aggressive and expect love to always be reciprocated. This practice is actually not loving, its destructive. Forcing a hug on someone who wants a handshake or a wave is not loving. Love is about seeing and being seen. How can we authentically see someone else when we are acting unconsciously or doing what we think we should do as awakened white men?

Learn to love with empathy and compassion, share your love openly but dont force it on anyone who isnt willing or wanting to receive it. Intuition is your best asset here, listen to what each environment calls for and what love looks like in every unique situation.

ConclusionI know some of these suggestions may be confronting. Theyve been super challenging for me. As I become more aware of my privilege in this white male cis-gendered able body, I find myself frustrated by the behavior of my peers who work deeply on themselves without working as deeply on their relationship with the communities that exist beyond their chosen families.

My intention is not to shame or put anyone down, its simply to illuminate where Im at in this awakening and encourage other white men to join me. Lets be better allies and peers, lets get on board with the world as it evolves.

As our brilliant friend Pharrell recently said in GQ, Because the dominant force on this planet right now is the older straight white male. And theres a particular portion of them that senses a tanning effect. They sense a feminizing effect. They sense a nonbinary effect when it comes to gender and its a fearful thing. Its time to drop that fear and come into love and action.

An original publishing of this work can be found on Medium

Ethan Lipsitz is a visual artist and founder of Extremist Love, a platform that advocates for love activism with media, art, technology and experience. Find him every week spreading love with his podcast Love Extremist Radio and traveling the world as an artist and facilitator.

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Waking Up To My Whiteness - The Black Wall Street Times

Recommendation and review posted by Bethany Smith

Ive tried dozens of multivitamins over the years: everything from the cheap generic grocery store brands to expensive options designed to aid in achieving specific health goals. For the most part, I havent noticed much of a difference when taking the vitamins, though I feel sluggish when I dont take any multivitamin.

However, when I recently tried Rootine vitamins, it was a bit different. I felt a little sharper mentally and physically. And in the month I tried Rootine, my health was excellent. I didnt experience any noticeable sickness or illness. Whether or not these observations can be attributed to the vitamin, I cant say. But based on my experience, Rootine is a unique multivitamin worth checking out.

Before we explore my experiences with this multivitamin, I need to provide a few disclaimers: First, this review is based on my opinion this is not a scientific review of the vitamin. Our health editor has looked at the research, and there is a lack of evidence affirming Rootines claims that a DNA test can provide a beneficial multivitamin.

Additionally, before taking supplements, its always a good idea to check with your healthcare professional first to determine if the supplement is right for you. And lastly, be careful to keep these vitamins out of reach of children.

Rootine is different from other multivitamins because the company creates a custom multivitamin based on your lifestyle, health history, and a DNA test.

To get my custom-made vitamin pack, I first answered an 18-question lifestyle quiz. This includes questions like:

The quiz takes about 10 minutes. You then enter your contact information so Rootine can send you a DNA test kit. If you already have DNA test results from 23andMe, Ancestry, or similar services, you can simply upload your genetic data, and Rootine will analyze it. This is much faster (one or two days) than doing a DNA test from scratch. You can also upload blood panel results from a health care professional to provide even more data to help Rootine craft a custom multivitamin.

I chose to submit my DNA via Rootines kit. With the kit, you swab out your mouth first thing in the morning. You then send it back to them in the postage-paid box. Collecting the DNA samples takes about 15 minutes.

Six weeks after I mailed the DNA test back, I received my first month of vitamins.

Rootine is a subscription service. So after the initial quiz and DNA test, you receive 30 packs of vitamins each month for $60 per month. Each pack is filled with microbeads that youre supposed to take with a meal each morning.

Printed on the box containing my packs were the supplement facts and ingredients. Though the numbers will vary based on your personal profile, my packs each had at least 100% of the recommended dietary allowance (RDA) of vitamin C, vitamin D3, vitamin E, vitamin B2, vitamin B6, folate, iron, zinc, and selenium. There were also significant amounts of fiber (5g), calcium, magnesium, manganese, copper, alpha-lipoic acid, CoQ10, MSM, and phytosterol.

When you access your Rootine account, you can see why your multivitamin contains the nutrients it does. For example, my vitamin has 506 mg calcium, which is higher than most because Rootine determined my lifestyle and genes warranted an elevated dose. My profile also shows me what the vitamins are intended for. For instance, as the most abundant mineral in the body, calcium is needed for strong, healthy, bones.

Rootine was co-founded by Dr. Daniel Wallerstorfer, who is a leading genetic scientist and has more than a decade of experience building genetics and nutrient labs.

I had the opportunity to ask him about Rootine over email, and he gave me a long list of examples for why taking DNA, lifestyle, and blood nutrient levels into consideration is important when choosing a multivitamin. We dont have room to cover all of them in this review, and theres an easy-to-understand explanation here, but here are a few ways a custom-made vitamin could be advantageous for you, according to Dr. Wallerstorfer:

I liked that there were no megadoses of any of the vitamins or minerals. At the most extreme, my vitamin C dose was 182% the RDA. Though there is no specific definition of megadose, its usually used to describe taking many times the recommended amount.

You need to follow the directions for how to ingest the microbeads. I figured Id just toss them in a bottle of water and drink them. This was a mistake. I had trouble getting the beads down my gullet. They would stick to the water bottle and the crevasses between my teeth. You need to put them in a thicker substance that doesnt need chewing. A thick smoothie might work okay (add after blending) or you might sprinkle it on top of yogurt. My favorite method for swallowing the beads was to pour a little at a time directly onto my tongue this takes some practice and take a swig of water.

I found the microbeads annoying, but they may be a nice option if you have trouble swallowing large multivitamins. Also, Rootine co-founder Rachel Sanders told me the design ensures the best quality product and optimal delivery for vitamins and minerals. She added, The innovative slow-release microbeads deliver a customized dosage of vitamins into your bloodstream throughout the day, which is aligned with how the human body would absorb nutrients from food.

The DNA test was a little bit of a pain. Youre supposed to swab out your mouth first thing in the morning before you eat or drink anything. I need espresso to exist and down shots almost before I even open my eyes. It took some real trickery to derail my normal routine to do the DNA test.

Once I sent the test back, it seemed like there was a huge window six weeks before I finally got my vitamins. Fortunately, they told me this would be the case ahead of time and sent updates throughout the process. Plus, you only have to do the test once before the vitamins arrive like clockwork. You might also consider skipping the DNA test altogether since the efficacy of it is questionable.

After the long customization process and once I got the hang of the microbeads, I found Rootine to be an outstanding multivitamin that, based on my opinion, kept my health on track even when my eating was less than exemplary. But is it worth the $2 a day price tag?

Most multivitamins take a one-size-fits-all approach, which is great if youve done your research and can determine that the supplement has exactly what you need. If you are in the dark and want to get the vitamins and minerals you need to maintain a healthy lifestyle, it might be worth spending the money to get a supplement designed for you. Also, if you find that you take a cocktail of supplements in the morning, it might be worth it to consolidate into one catch-all pack.

If after reading all of the above you decide Rootine is not for you, you might consider some of the options in our guides to the best womens multivitamins and mens multivitamins.

However, if you can afford it, I strongly recommend trying Rootine. You cant beat a multivitamin that attempts to take your lifestyle and genetics into consideration to keep you healthier.

Pros: Customized multivitamins, microbeads may be easier for users to swallow than the usual large pills, vegetarian/vegan, no megadosing

Cons: Expensive, long lead-up time if doing the DNA test, swallowing the microbeads takes some practice

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I tried a customized multivitamin subscription that took into consideration my DNA and lifestyle heres how it works and how I felt after taking it -...

Recommendation and review posted by Bethany Smith

By Philip Guelpa 12 November 2019

The causes of and processes whereby egalitarian societies based on a hunting and gathering economy, which characterized the overwhelming majority of human existence, were transformed into stratified, class societies based on agriculture constitute one of the fundamental questions to be addressed in the study of human cultural evolution.

Agriculture was developed independently in a number of separate locations around the world (e.g., the Near East, Southeast Asia, Mesoamerica, the Andean region) almost simultaneously (in geologic terms) at the end of the last Ice Age (the Pleistocene), roughly 10-12,000 years ago. At first, farming communities remained small and the social structure relatively egalitarian, as it had been during the preceding hundreds of thousands of years when humans relied on hunting and gathering. However, over the next few thousand years, the economies of these societies changedagriculture became more productive, technology more complex, interregional trade expanded, and populations grew in size. Some villages became towns, and some towns became cities.

As part of this process, the division of labor within society became more complex. Individuals could no longer undertake all of the productive and social tasks required to carry out normal life, as had been the case previously. Administrative control over land and productive forces gradually became alienated to a small segment of the population. And, due to this control, the elite was able to arrogate a disproportionate share of societys wealth to itself. In short, classes with different roles and interests emerged. By the period known as the Bronze Age in Europe and the Near East, beginning around 3300 BC, highly developed civilizations were emerging in a number of locations, including Mesopotamia, Anatolia, and Egypt.

There is still much to be learned about this process of social differentiation and class formation. How did hierarchical relationships develop out of pre-existing egalitarian social structures based on kinship? Did wealth disparities grow within families or between families, or both? Was the gradual weakening of kinship ties between members of the same social group, which had entailed obligations of reciprocal support, the only mechanism of class formation?

Recent research into Bronze Age populations in Germany provides some insight into a certain aspect of class formation, which may be more broadly relevant. In Europe, aside from the Aegean area, such civilizations did not develop in the same manner as in the territories to the east, with their high degree of urbanization and intensive, often irrigation-based, agriculture. Nevertheless, the process of social differentiation and class formation was under way.

Archaeological and biological indicators of social stratification in agricultural societies are evident in Bronze Age Europe dating from roughly 3200 to 600 BC.

Evidence of class differences between a wealthy elite, exemplified by princely burials with lavish grave goods, and a large peasant population was already clear. Marked social stratification has been documented in the central German Unetice Culture (2200-1600 BC), located in a region of especially fertile soil, which was characterized by near-state-level social organization with established armies. However, the peasantry, which constituted the bulk of the population, has generally been viewed as an undifferentiated class of small farmers, in which kinship ties remained the basis of social organization within a single class.

New research reveals that social differentiation existed within the peasantry during this period, at least in one region of Germany, with some members of the population occupying roles based on other than familial ties, such as servants or even slaves. Such small-scale stratification may provide clues to an understanding of the origins of the larger-scale class structure.

An article recently published in the journal Science, Kinship-based social inequality in Bronze Age Europe (Mittnik et al., 10 October 2019), presents a detailed analysis of genetic and archaeological data from the German Lech River valley derived from sites spanning a 700-year period during the Early Bronze Age, marking the economic and social transition from the Late Neolithic to the Middle Bronze Age period (from roughly 2750 BC to 1300 BC).

Based on assessment of genetic relatedness between 104 individuals buried in 45 local farmstead cemeteries plus additional data, the study finds that in a set of nearby farming communities there existed core groups of families centered on resident male-based lineages (patrilocality), with women from other communities marrying in (female exogamy).

Individuals buried at the same site were more closely related genetically than those buried at different sites, indicating both long-term residential stability of families (more residential mobility would result in greater genetic diversity) and a stable subsistence system that could reliably sustain these communities through time.

Archaeological evidence in the form of grave goods indicates the relative wealth of the resident core family, based on the quantity and quality of burial offerings. The more numerous (presumably more prosperous) families tended to have the richer grave furniture.

A correlation in wealth and status was also seen in genetically identified parent/child relationships, indicating a pattern of inheritance. Perhaps most tellingly, this holds true for subadults, demonstrating that wealth and status were ascribed by inheritance rather than being achieved by the individuals actions in life. Closely related individuals tended to be buried in proximity to each other, further emphasizing status differentiation. At one site, the high-status individuals were interred in burial mounds.

It is notable, however, that both males and females in these core family groups were interred with significant quantities of grave goods, suggesting a degree of social equality between the sexes.

Significantly, two components of the burial populations in these communities do not conform to this model of stratified, kin-based social organization. The first consists of burials of female individuals unrelated to the local families and with indications of having grown up outside the region who, nevertheless, were interred with significant quantities of grave goods, indicating relatively high social status. Their role in the community is unexplained, but their presence suggests some sort of specialization.

The other group consists of individuals also unrelated to the local families, though not of different general ancestry, but this time interred with only poor grave goods. The authors conclude, Considering both grave furnishing and kinship, people of different status and biological relatedness likely lived together in the same household, which should therefore be seen as complex and socially stratified institutions. Again, the specific roles of these individuals are unknown, but their position outside of the kinship structure and their low social status, marked by a paucity of grave goods, suggest a subservient position, resembling a domestic servant or farm hand.

In effect, such individuals would represent, in incipient form, a kind of servant or slave class, distinct from the landed peasantry. Their labor would have contributed to the wealth of the core family, with little or no benefit to themselves, at least as indicated in the archaeological record. The use of supplemental labor beyond the members of the kin group suggests that new forms of more labor-intensive agriculture, such as use of the plow, may have been introduced during the Early Bronze Age, necessitating an augmentation of the labor force.

How these outsiders came to be functionally part of these households, but yet remained distinct, as revealed by treatment at death, is unknown and worthy of further research. Possibly they were war captives (evidence of warfare exists during this period) or they were members of other families that had fallen on hard times, causing their kin group to dissolve, leaving these individuals homeless and without support.

Notably, weapons were found with significantly higher frequency in the graves of males belonging to the core family than in those of the outsiders, suggesting differential socially sanctioned use of force.

The Science authors conclude that The EBA [Early Bronze Age] households in the Lech valleyseem similar to the later historically known oikos, the household sphere of classic Greece, as well as the Roman familia, both comprising the kin-related family and their slaves. This suggests that social differentiation and inequality had deep historical roots in early European farming communities.

This study is impressive in its use of detailed genetic analysis to reconstruct multi-generational family trees, which can then support comparisons between distinct family-based social units drawn from a sufficiently large sample size. This, in conjunction with the analysis of grave goods and the spatial positioning of the interments, provides a fine-grained reconstruction of the social and biological structure at a time when these farming communities were approaching a period of dramatic change.

The ability to conduct such studies relies on the collaborative efforts of a variety of specialists. This would not be possible, however, without the collection of data from numerous sites that form the basis for comparative studies, emphasizing the need for the excavation of such sites before they are destroyed by development.

See more here:
Social inequality in Early Bronze Age Europe - World Socialist Web Site

Recommendation and review posted by Bethany Smith

This is part 2 of a 4-part investigation of the science surrounding the chemical BPA and the U.S. regulatory push to discredit independent evidence of harm while favoring pro-industry science despite significant shortcomings.

PULLMAN, Wash.Tiny pink lab mice disappear then quickly reappear again from within a cage's hardwood chip bedding. The squirmy newborns are part of Patricia Hunt's latest series of experiments on the health impacts of industrial chemicals widely found in products we all use.

Here, in a dim basement at Washington State University, where metal shelves are stacked high with rows of plastic cages, Hunt has made multiple discoveries that call into question claims made by U.S. federal regulators about the safety of one of those chemicals: bisphenol A, or BPA.

Virtually all of us have tiny amounts of it in our blood and bodies at least two millionths of a gram per liter of blood, the equivalent of about 14 pinches of table salt in an Olympic-sized swimming pool. The Food and Drug Administration maintains that the chemical, known to mimic and mess with natural hormones, poses no real health threat at such levels.

Hunt's results say otherwise. Since being among the first scientists to report on the harmful effects of BPA on mice in 2003, Hunt has further identified genetic abnormalities, fertility problems and other health impacts in animals at very low doses.

We encounter the chemical every day in food and beverage cans, plastic packaging and cash register receipts. And it doesn't appear to be going away anytime soon: The global BPA market is predicted to surpass $30 billion by the mid 2020s. "I'd like to vote the bisphenols off the planet. But that's not likely to happen," Hunt later tells me in an upstairs room flanked with microscopes used to view tissues from the mice. "The more immediate goal should be to change the way we do toxicity testing for these types of chemicals."

Her findingsand those of othershave implications far beyond BPA to the hundreds of other chemicals capable of wreaking similar havoc on our hormones.

Discoveries in Hunt's lab also hint at how an evaluation of a chemical can easily conclude that it is safe even if it may cause harm. Twice now, Hunt has found BPA or one of its equally troublesome replacements, such as bisphenol S, coursing through the bodies of her control mice animals not intentionally dosed with a chemical in her experiments. The source: those plastic cages housing the mice.

Natural wear and tear of Hunt's cages and, more recently, potential cross-contamination in a shared wash area from another facility's damaged plastic cages, likely led to tiny amounts of the chemicals getting into the animals. She has had similar misadventures with contamination from phytoestrogen-laden mice chow, wildfire smoke and cleaning products. Such unplanned exposures could dilute differences in health outcomes between a study's experimental and control animals, making it difficult to detect if a chemical truly poses a health risk and, ultimately, making it all the easier for hazardous things to continue finding their way into our bodies.

Both times Hunt found bisphenol contamination, she essentially lost her experiment. "It was a whole lot of dj vu all over again," said Hunt, who is in her mid-60s, her face framed by rimless glasses, cropped gray hair and small hoop earrings.

Hunt's repeated frustrations point to just one of the myriad ways a study's design, implementation, analysis, interpretation and presentation can diminish, obscure or even totally hide any true health effects of a chemical. The risk of such oversights may be especially high for BPA and other chemicals that interfere with the action of hormones in the body, a class called endocrine disruptors.

An investigation by Environmental Health News suggests that an ongoing multimillion-dollar project called Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or Clarity, includes a number of these potentially harm-hiding elements. Launched in 2012 by the U.S. Food and Drug Administration (FDA), the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP), Clarity combines a traditional regulatory toxicology study from the government and investigational studies from academics who wield more modern techniques. The goal is to reconcile a long-standing dispute over data and conclusions on BPA's health effects. But it's bigger than BPAthe collaboration aims to determine if the study methods used by government regulators are sufficient to determine the safety of the hundreds of chemicals suspected of being endocrine disruptors. The implications could reverberate through the entire U.S. chemical regulatory structure.

FDA officials continue to claim that concerns over low-dose effects of BPA are unfounded; academic scientists continue to publish studies that underscore risks such as altered brain development, cancer and diabetes.

Through interviews and emails obtained via Freedom of Information Act requests, EHN has uncovered various signs of deficiencies in the FDA's science on BPA and its handling of Clarity. While each sign alone could be considered a red flag, viewed as a whole, they suggest that the FDA is missing some big warning signs about BPA and, therefore, likely misleading the public about its safety.

Some of these signs can be traced back to before the study began. For example, evidence of BPA contamination emerged during a preliminary Clarity study. If the animals in the main Clarity study had been contaminated, that would dilute any true differences between exposed and unexposed groups. And during the study's design, the FDA insisted on using a specific type of rat that had been shown to be insensitive to the effects of estrogen and its mimics, including BPA. Michael Hansen, a senior scientist for Consumer Reports, compared using this rat to operating a radar gun that doesn't detect speeds under 100 mph and then concluding that no one is speeding. "It is almost as though they were trying not to find differences," Hansen told EHN.

Other potential red flags popped up during the course of the study, such as the small number of animals provided to some of the academic scientists also limiting their ability to detect differences and a public statement on BPA's safety made by the FDA before all the data was in.

"Is it total incompetence or fraud? I don't know their thinking. But neither choice is pleasant, and it represents the waste of about $15 million in public funding," Pete Myers, CEO and chief scientist of Environmental Health Sciences, told EHN. (Editor's note: Myers is also the founder of Environmental Health News, though the publication is editorially independent.)

An integrated report that pulls together government and academic findings is in preparation and expected by the end of 2019. Eight of the 14 academic investigators have so far published 14 papers based on their findings in a scattering of different peer-reviewed journals such as Endocrinology and Toxicological Sciences. Many found health effects in rats exposed to very low levels of BPA. "There isn't one big publication coming out with the academics' results," Gail Prins, a researcher at the University of Illinois at Chicago and Clarity investigator, told EHN. "I'm afraid that significant findings across academic studies are going to be buried."

Federal regulators have also now published their part of Clarity, one big publication known as the Clarity Core Study that was widely publicized. Their results, too, reveal some effects at low doses. Yet they again concluded in their report and in the accompanying press that exposing rodents to BPA did not result in health effects at the low doses to which people are generally exposed.

"I think that a lot of this is failure by design," Laura Vandenberg, an environmental health researcher at the University of Massachusetts-Amherst's School of Public Health and who was not involved in Clarity, told EHN.

The lab of Cheryl Rosenfeld, a biologist at the University of Missouri and another Clarity investigator. (Credit: Cheryl Rosenfeld)

Ila has just returned from her first puppy training class as I arrive at Hunt's home in Moscow, Idaho. Labradoodles are known to have a lot of energy, and Ila's bouncy greeting of this newcomer corroborated that reputation. Hunt tells me she is surprised Ila has yet to hurdle the childproof gate that separates the mudroom from the dining room. "I keep thinking she could hop over it so easily, but she just never does," says Hunt.

Other dog breeds may be calmer, but Hunt and her husband had good reason to go with a labradoodle: The breed sheds less fur and other allergy-triggering substances than other breeds. "We had a lab once before and the hair was everywhere, and our allergies were terrible," she says. Sure enough, I made it out of her house without any of Ila's dark brown fur.

Like dogs, lab animals can be diverse in their behavior and biology.

To determine the impact of a chemical, scientists track various changes, called endpoints, in an animal such as organ weight, tumor development, changes in behavior or insulin levels. Different strains of different rodents are often used in different studies. Hunt and many others who investigate the impacts of hormones and hormone mimics often opt for strains of mice. For one, the animals can be more practical they eat less and take up less space than rats. Certain strains of mice are also known to be particularly sensitive to hormone changes.

"If your animal model can't respond to your experimental manipulation, then you can never determine if the manipulation does anything, ever," Scott Belcher, a biologist at North Carolina State University, and a Clarity investigator, told EHN.

Belcher, too, tends to use mice in his studies of impacts on the heart. "Rats and mice aren't the same things," he said.

The FDA's go-to animals for chemical toxicity testing are Sprague-Dawley rats bred at the FDA's National Center for Toxicological Research in Jefferson, Arkansas. These were the animals chosen for Clarity, despite objections from some academic investigators. The rats have long been used in government regulatory studies, and they have long been known to have low sensitivity to BPA.

Jerry Heindel, the health scientist administrator at NIEHS when Clarity was initiated, noted one particularly unusual characteristic of the rats. "Estrogen stimulates puberty in a female animal. You can generally make puberty come up two, three days earlier by giving an animal extra estrogen," he told EHN. "But in this animal, you can't." A couple days early is relatively significant for an animal that, on average, hits puberty at 38 days.

"So some endpoints are going to be insensitive or much less sensitive. There's no getting around that," said Heindel. (The FDA did not respond when asked about the choice of study animal.)

Of course, animal studies all have their limitations. The only way to be relatively sure of a chemical's effect in humans would be to study the effect of that chemical in humans. In a first-of-its-kind study published in 2018, researchers exposed a small group of people to a very small amount of BPA and saw a link to a precursor of type 2 diabetes. The researchers first lowered participants' BPA levels and then brought those levels back up to the normal range. (Myers was an author on the paper.) Still, to knowingly expose people to something suspected of being harmful can raise some ethical concerns. Epidemiological studies do the next best thing they take advantage of the natural experiment currently underway by estimating levels of exposure and health outcomes in people and then determining if and how the measures might be related.

In his epidemiological studies, John Meeker, an environmental health scientist at the University of Michigan School of Public Health, has uncovered evidence that BPA may alter circulating levels of hormones and birth outcomes. He laments how regulators have remained reliant on animal toxicology studies. "We need more harmonization of animal and human research in the regulatory setting," he told EHN.

Both research methods have their place. Toxicology studies allow scientists to directly compare exposed and unexposed animals, control the experimental environment and precisely measure outcomes. Meeker noted that his epidemiological findings do not always match up with toxicology studies. "When they do match up, it gives you more confidence," he said. "When they don't, it could be due to chance in human studies or due to species differences in their responses to exposure."

Thomas Zoeller, a biologist at the University of Massachusetts, Amherst, and Clarity investigator in his lab. (Credit: Umass.edu)

Thomas Zoeller, a biologist at the University of Massachusetts, Amherst, suggested such species differences resulted in what he called "unprecedented" findings in his Clarity study. "This is a very odd strain of animal," he told EHN.

For a century, explained Zoeller, researchers including himself have studied the impact of thyroid hormone insufficiency on brain development in animal models. "Nobody sees a lack of effect," he said. Zoeller treated some of his Clarity rats with a medication used for hyperthyroidism, propylthiouracil, that suppresses thyroid activity. And while it did succeed in altering thyroid hormone levels, as expected, the brains of his rats appeared almost unfazed.

"The data that we have show that these animals are different," added Zoeller. "They may just be different with respect to the thyroid system. But I doubt that." He suggested that because the strain was selectively bred to be prolific breeders over many generations, other changes likely accompanied the increased fecundity.

The impact of species differences can go both ways, explained Patrick McKnight, a measurement scientist at George Mason University in Fairfax, Virginia. Using a model animal that is overly sensitive to the agent of interest can artificially inflate the size of an effect, he told EHN.

Still, Linda Birnbaum, former director of the NIEHS and the NTP, shared the academics' concerns. "When we started this study, I remember having nightmares thinking, 'What happens if we don't find anything?' Because we really didn't have much data on using this strain of rat and BPA," she told EHN. "In retrospect, if I were to do this study again, I probably would've done it in mice and I probably would've used a strain which had been reported to have clear effects."

Vandenberg added her worries. "Why are we using this strain to test all chemicals if we now have evidence that it is not the right strain?" she added. "Have we made a mistake on everything?"

Linda Birnbaum, former director of the NIEHS and the NTP, speaking at Northeastern University's Our Environment, Our Health event in 2016. (Credit: Matthew Modoono/Northeastern University)

Even when assuming a chosen animal is a reasonable model to test a chemical of interest, the next critical factor for a successful study is enlisting a large enough number of those animals to detect health effects if there are effects to be detected. The more animals, the more so-called statistical power a study has to reveal the true effects of a chemical.

Prins believes that the FDA shortchanged her on animal numbers. She had determined prior to the study that she would need at least 18 animals per treatment group to have adequate power to detect differences between the groups. Yet for one of her treatment groups she received just four animals. "When you get that number of animals, you can't get a significant effect," Prins told EHN. "I would go out on a limb and say this was done intentionally."

In a 2008 federal review of the evidence on BPA, the FDA excluded a study of hers from their risk assessment because, in part, her study didn't include enough animals. That FDA assessment, which ended up relying on just two studies both funded by industry restated the agency's stance that BPA is safe.

"The FDA wants to tell a story," said Prins. "They want to tell the story that BPA is fine. And it's not."

Another Clarity researcher, Jodi Flaws, struggled with a similar power problem in her Clarity research. She ended up with just three animals in one of her treatment groups, Flaws told EHN, because the tissue sent to her by the government was not collected on the same day of the animals' menstrual cycle a critical detail that she had requested.

Her team still managed to publish a paper with their results, which indicated that BPA exposure at some doses altered hormone production and the number of developing eggs in female rats. But she told EHN that the small number of animals underpowered them to see the stronger results in Clarity that they had seen in their prior studies.

"There was no way to make sense of anything," said Flaws, who studies genetic and environmental factors that affect the female reproductive system at the University of Illinois at Urbana-Champaign. (The FDA did not respond to a question regarding the number of study animals provided some researchers.)

John Bucher, a senior scientist with NTP and NIEHS, and one of the Clarity leads, acknowledged this shortcoming of Clarity. "We recognize that some of the investigators didn't get as many samples as they would have liked. And that's regrettable," he told EHN. "This was an enormously complicated study and we tried to accommodate as many requests as possible.... We probably overpromised."

On Hunt's office wall in Pullman hangs a framed quilt made by the Sarum Quilters of Salisbury, England. The primary-color design depicts the DNA double helix, genes, eggs and sperm that have been the primary characters in her 40-plus years of research. Other genetics references fill the room there is the thick blue Dictionary of Genetics, and the half-moon table braced by arms and a back that are shaped as x and y chromosomes.

Human-made chemicals only began to take center stage in the latter half of Hunt's research career. In fact, before 1998, Hunt knew nothing about BPA. She was simply investigating at the time how hormonal changes in mice might affect the quality of a female's eggs. Then, some unexpected data began to emerge: Abnormal eggs appeared in both her experimental and control animals. "We knew we had a problem," said Hunt, wearing a dog-fur-free blue long-sleeve t-shirt and dark blue jeans, along with a multi-colored stone pendant. "It took me a month to track down what was going on."

At first, she suspected everything from construction project debris to pesticides sprayed nearby. Then she took a closer look at the plastic cages. As they were repeatedly washed and autoclaved, she could see that the cages were starting to degrade. Across the street from her lab was the university's polymer sciences building. She recalled running over to those scientists and learning from them that BPA was likely leaching out of her cages.

While some health effects of BPA were already suspected by the late 1990s, impacts on female eggs and, therefore, potentially increased risks of miscarriages and birth defects were not yet among them. Hunt spent the next three years confirming her data. Today, female reproductive problems are included with the published risks associated with BPA exposure. Hunt has continued to investigate how BPA and other endocrine disruptors might further affect genes and reproduction. And, while not a participating scientist, she is also keeping a close eye on Clarity.

In emails and PowerPoint slides obtained by EHN, FDA scientists acknowledged as far back as July 2013 that contamination occurred in a study done to determine Clarity's feasibility. During this preliminary study, which was carried out at the same facility that later housed the animals used in the large-scale Clarity study, tests had revealed that BPA levels in control rats were similar to those in the four lowest exposure groups.

That's a problem: Endocrine disruptors, like natural hormones themselves, can impact the body at extremely low levels. So, unintentionally exposing controls to a tiny dose of a chemical may result in those animals showing similar effects as experimental animals intentionally exposed. In a comparison of health effects between the control and experimental animals, any true differences between the groups would be diluted.

In January 2014, Barry Delclos, a biochemical toxicologist with the FDA, wrote in an email that, while data from the preliminary study revealed "the potential for significant effects in the low BPA dose range," the BPA contamination "confounds the interpretation of the changes observed in the lowest BPA exposure groups."

Marianna Naum, an FDA spokesperson, told EHN in an email that data suggesting contamination of the control rats might have been due to "the housing of the animals in the same room as animals treated with high BPA doses." Although Naum also noted that the agency has still not confirmed the source of contamination, and that it remains unclear to what extent any contamination might have affected the rats in Clarity. Still, the government's Core Study report asserts that contamination was not an issue.

Heather Patisaul, a professor of biology at North Carolina State University and a Clarity investigator. (Credit: NCSU)

"The fact is, they don't know where the contamination came from and they don't know if the Clarity controls were contaminated," said Zoeller. "They didn't measure it."

"If you can't ferret it out, it's like shooting yourself in the head before you even start the study," added Hunt.

Birnbaum expressed little concern about that potential contamination. "When we deal with environmental chemicals, almost everyone or every animal has some exposure," she said. "Control doesn't have to mean zero it means you know what you have and it is lower than the intentionally exposed."

Hunt still maintained that contamination with an endocrine-disrupting chemical could derail a study. "If you have contamination, you don't have a control. There's no way around it," she said. "It puts a shadow over the whole thing."

It was unlikely a pleasant experience to be a Clarity rat. Every day, while restrained, a lab technician stuck a tube down its throat and into its stomach to deliver a solution. For the experimental animals, the solution contained BPA. For the controls, it either contained a dose of ethinyl estradiol, the synthetic estrogen in oral contraceptives, or nothing. The method is called gavage.

FDA scientists argue that gavage is a better way to ensure the correct dose is getting into an animal than putting the chemical in its food. Academic scientists counter that gavage triggers chronic stress and can therefore significantly alter hormone levels another means by which any actual differences between experimental and control animals could be artificially diminished. Because the control animals were also exposed to the stress of gavage, they argue, there was no true control group of rats in Clarity.

Heather Patisaul, a professor of biology at North Carolina State University and a Clarity investigator, co-authored a 2013 study in which she found that gavage alone was enough to change the expression of hormone receptors and other genes in areas of the brain that are known to respond to stress.

"Clearly animals gavaged and not gavaged are not the same," she told EHN.

During the planning of Clarity, the FDA made it clear that use of gavage was non-negotiable, noted Heindel, the former NIEHS health scientist administrator. The academics could accept that or simply not participate.

So, many reluctantly signed on, despite believing that gavage and other design factors dictated by the FDA would make it extra difficult to show effects that many of them had identified in their previous studies. Use of gavage was among the criteria adopted by the government decades ago for studies that evaluate the safety of chemicals. In addition to standardizing the number and type of animal used, and levels of exposure to the chemical of interest, these so-called "guideline" studies also generally focus only on traditional endpoints such as overt signs of toxicity, rather than the unique effects of endocrine-disrupting chemicals that academics tend to investigate.

Academics usually use other means of administering chemicals to animals. Prins delivers BPA into a mouse's mouth with a pipette tip. Andrea Gore, a neuroendocrinologist at the University of Texas at Austin, said her lab is starting to administer chemicals to animals via vegetable oil placed on a piece of cookie. "There is evidence that gavage is stressful," Gore, who was not involved in Clarity, told EHN. "When you're talking about low doses of endocrine-disrupting chemicals, that is extremely relevant."

Hunt, too, feeds her mice BPA via corn oil. "We gently pipette oil into the mouth and the animals actually like it," she said.

Researcher Pat Hunt with lab mice. (Credit: Lynne Peeples)

Whenever it is wet outside, Hunt makes sure to clean off Ila's four paws before they come inside. "We pause for paws," she said. Given the puppy's high energy, it is a given that the outside mud would end up just about everywhere inside her house. Yes, Hunt is familiar with both dirty dogs and dirty data and the struggle to keep puppies and studies under control.

Contamination is one of the ways in which a study and its results might become tainted; a lack of control is another.

Standard protocol for research on endocrine disruptors demands the inclusion of both "positive" and "negative" controls groups of animals that researchers can then use as a baseline comparison against their exposed group of animals. A negative control is your typical study control animal that doesn't receive any exposure. (Again, in the case of Clarity, academics argue that this purity was spoiled by potential contamination.) A positive control is exposed to something with a known response.

For example, academic studies of BPA have generally included a group of animals exposed to a synthetic hormone for which effects are well known: ethinyl estradiol, the estrogen mimic in oral contraceptives. This positive control helps scientists decipher whether or not a lack of an effect in BPA-exposed rats compared to negative controls was because the experiment simply did not have the sensitivity to detect estrogen-like effects or because BPA really had no such effect.

When the government initially declared their plan not to include positive controls in Clarity, according to emails reviewed by EHN, 11 of the academic researchers pleaded for them to reconsider. In one of the emails from April 2012, Frederick vom Saal, a professor of biology at the University of Missouri-Columbia and a Clarity investigator, stated that without these controls, the experiment could "waste millions of dollars and generate uninterpretable data."

Positive controls were eventually provided and used for most, but not all, of the Clarity studies. Kim Boekleheid, a toxicologist at Brown University, was the only academic scientist not to use a positive control in his study of male reproduction. His decision ignited ire among some of his Clarity co-investigators, especially upon the release of his results. While previous academic studies have found that male reproduction is very sensitive to BPA, Boekleheid's study concluded that exposure to BPA did not harm the testes or sperm in rats. Hunt and others question how he could be so sure without a positive control. Boekleheid declined to be interviewed for this story.

An additional type of control was enlisted by the government in their Core Study. When they found higher rates of mammary cancer in rats exposed to low doses of BPA compared to negative controls, the FDA authors then also looked to a control group from a somewhat similar study conducted about a decade earlier. Turned out those non-BPA-exposed animals, considered "historical" controls, developed more mammary tumors than the non-BPA-exposed rats in the Clarity study. The government used this as one of their reasons to disregard the mammary cancers as a true BPA effect.

Outside scientists questioned their motives and noted, for example, that the animals not exposed to BPA in the old study would have been housed in plastic cages made partially of BPA. So, those rats may, too, have been inadvertently exposed to small doses of BPA. Gore added that "things change over 10 years." In work in her own lab, she has found that animals vary across generations "even if they are the same strain, fed the same food and all animal husbandry is done the same."

Ana Soto, an endocrinologist at Tufts University and a Clarity investigator, with fellow Tufts researcher, Carlos Sonnenschein (Credit: Tufts University).

Ana Soto, an endocrinologist at Tufts University and a Clarity investigator suggested that historical controls are typically only used when a difference is not seen between an experiment group and control group. "They are doing the opposite. They seem to be trying to minimize the fact that they found differences between BPA-treated and the simultaneous control," she told EHN. "That is where you start wondering whether this choice is plainly inept or disingenuous."

Vandenberg too was curious about the government's use of historical controls in guideline studies, such as the Clarity Core Study. So she took a closer look at how the government dealt with other outcomes. For example, they found a significant increase in pituitary cancer in female rats exposed to ethinyl estradiol and used that as support that the positive control worked in Clarity. However, the same historical controls the government referenced for cases of mammary cancer also had a rate of pituitary tumors comparable to the ethinyl estradiol group. "If they had applied the same logic to the ethinyl estradiol pituitary data in Clarity as they did to the BPA mammary gland data, they would have had to conclude that the positive control had no effect," she said.

And that would have called into question the rest of their results.

"When the FDA didn't like the data they got, they went back into their own lab to try to dismiss it," added Vandenberg. "But then they don't do that for the data they like. This asymmetric treatment of data is one more example of how the FDA seemed to manipulate the interpretation of the Clarity data."

Zoeller agreed. "They at least appear by their inconsistency to have a preconceived conclusion that they arrive at by selective logic," he said.

In part 3 of this series, EHN further details critical questions surrounding how the FDA assesses the evidence and frames their conclusions on BPA, as illustrated in the agency's handling of Clarity.

Read this article:
Exposed: On the edge of research honesty - Environmental Health News

Recommendation and review posted by Bethany Smith

The case surrounding death row inmate Rodney Reed has gained national attention since celebrities like Kim Kardashian and Rihanna have come to the convicts defense, requesting the governor of Texas to stay Reeds execution.

Reed was convicted of the 1996 rape and murder of 19-year-old Stacy Stites due in large part to overwhelming DNA evidence and is set to be executed by the state in less than two weeks, on November 20.

However, Reed, a black man who believes he is a victim of racial bias, claims he did not murder Stites, but was having a secret consensual sexual affair with the teen. When her fianc Jimmy Fennell, a white police officer, found out, he killed Stites, Reeds defense attorneys have theorized.

When Reed was convicted, it was determined Stites was strangled to death by her own belt while on her way to a work at a HEB grocery story in Bastrop, Texas, in April 1996. Evidence also determined that Stites, who was also vaginally raped, was anally raped while being strangled to death. DNA from semen found in the teens vagina and anus matched that of Reeds.

The effort to stay Reeds execution is primarily due to Reed advocates and his legal team claiming a proper examination of forensic evidence shows that Stites was killed hours before she and Reed could have crossed paths, the Statesman reported in July.

But with all the celebrity-backed hype and social media fog surrounding the case, what are the facts? Here are some key details that you need to know.

I didnt know her, never met her, never talked to her, had no idea who she is, Reed told Sergeant David Board of Stites, court documents show. The only thing I know was what I saw on TV.

Reeds defense team suggested during the trial that Reed first denied he knew Stites because of racial prejudice, suggesting it was good sense for a black man to deny any connection to a dead white woman.

But according to the prosecutions opening statement, Reed denied knowing Stites to police after the defendant knew he had been linked to semen.

Reed began dating Caroline Rivas, an intellectually disabled woman, court documents revealed. Rivass caseworker noticed bruises on Rivass body and, when asked about them, Rivas admitted that Reed would hurt her if she would not have sex with him.

Later, Rivass caseworker noticed that Rivas was walking oddly and sat down gingerly, the response to the Supreme Court cert. petition said. Rivas admitted that Reed had, the prior evening, hit her, called her vulgar names, and anally raped her. The samples from Rivass rape kit provided the link to Stitess murder.

According to court documents, the victim, only identified publicly as A.W., says she was blindfolded, gagged, beaten, and orally, vaginally, and anally raped while she was home alone. The foreign DNA from A.W.s rape kit was compared to Reed; Reed was not excluded and only one in 5.5 billion people would have the same foreign DNA profile from A.W.s rape kit, the court doc outlined.

As noted by Breitbart News Brandon Darby, Reed has not been exonerated from the rape of the 12-year-old and a number of other women, but such cases were likely not pursued because Reed was served with the death penalty.

When someone gets a death penalty, the other cases are often not taken to court because of resources and not wanting to put other victims through trials once ultimate punishment already given. All of those cases are still there and have been the entire time, Darby explained.

Lucy Eipper, whom Reed has two children with, claimed he physically abused her, even when she was pregnant. He also raped her all the time, including one time in front of their kids, according to Eipper.

There was alsoVivian Harbottle, whom Reed was said to have raped six months prior to the murder of Stites. When she pleaded for her life for the sake of her children, Reed laughed at her, court documents reveal. The foreign DNA from Harbottles rape kit was compared to Reed; he could not be excluded, and only one person in 5.5 billion would be expected to have the same foreign DNA profile.

Reed also allegedly attempted to rape 19-year-old Linda Schlueter after he convinced her to give him a ride home. Reed led her to a remote area and then attacked her, documents outline. After a prolonged struggle, Schlueter asked Reed what he wanted and Reed responded, I want a blow job. When Schlueter told Reed that you will have to kill me before you get anything, Reed stated I guess Ill have to kill you then. Before Schlueter could be raped, a car drove by and Reed fled.

Reed was acquitted of the rape of 19-year-old Connie York. Though he at first denied knowing York, he later claimed, Yeah, I had sex with her; she wanted it.

Indeed, [the jury] knew that Reeds genetic profile was consistent with profiles developed from Stitess panties and the vaginal, rectal, and breast swabs taken from her body, the record stated. Reeds DNA is now consistent with that found on Stitess pants and her back brace, which also include Stitess genetic profile; namely, there is a mixture of Stitess DNA and male DNA on Stitess pants and back brace from which Reed cannot be excluded.

Essentially, Reed is now found on more pieces of evidence related to Stitess murder than ever before, it stated.

Following Fennells release, Stites family, including sister Debra Oliver, defended Fennell from accusations concerning Stites.

I guess in a way, part of him died that day too, you know? His life has never been the same, Oliver told Kxan News.

After she was found, he was heartbroken and Im the one who really sat with him a lot and held his hand, she added. He is not the murderer in this case, he never was.

Stacy didnt know Rodney, not at any time were they having an affair, the sister continued.

The difference between Jimmy and Rodney, is Jimmy took responsibility for the bad decision he made and he served his time and hes paid his commitment to society, she added. Id love for people to leave him alone and let him move on with his life.

A cousin of Stites, whos been estranged from the family, views Fennell as the killer, noting that Reeds DNA could have ended up in Stites vagina and anus any other way.

Snow admitted that Fennell sought him out for protection against other racially-aligned gangs in the prison, and agreed to give up a portion of his commissary for such protection. The two were never really friends, but Fennell once approached Snow in 2010 and bragged that he had to kill his n*****-loving fianc.

The affidavit has been used by the Innocence Project to advocate for Reed.

The question then is why was Reeds semen found in Stitess physically- and sexually-abused body? Reed unconvincingly claims a clandestine, consensual relationship, but that was rejected by the jury and every court to have considered it-without dissent (two state district-court judges, nine state appellate judges, one federal magistrate judge, one federal district-court judge, and three federal appellate judges), the trial court record said.

Robert M. Phillips, Fennells lawyer, said the Innocence Project was merely recycling claims that were made at trial, The New York Times reported. It was inconceivable, he said, that the people now coming forward would have stayed silent for so long if their accounts were true.

H/t Brandon Darby

Continued here:
Celebrities Push To Save Death Row Inmate Rodney Reed. But What Does The Evidence Say? - The Daily Wire

Recommendation and review posted by Bethany Smith

MetroHealth is opening a permanent clinic Tuesday at the LGBT Community Center of Greater Cleveland specifically to treat LGBTQ patients.

Greater Cleveland LGBT center, MetroHealth partner on clinic

MetroHealths Pride Network has operated clinics -- geared to LGBTQ patients -- within its existing facilities since 2007. Now, the hospital system is opening a clinic inside the community center for both well visits and specialized care, such as hormone therapy and HIV prevention. Daniel Hamilton is the community centers operations manager.

Its not just about testing. Its about preventative medication that will help people to make better health choices and reduce the risk of HIV when engaging in safer sex practices.

Hamilton also says he hopes having the clinic inside of the center will make getting care more convenient -- and less stigmatized -- for people who might otherwise delay treatment or ignore lingering illnesses.

The endorsement from the LGBT center, having the clinic here, and being able to make direct referral to a place thats already a place theyve come to feeling its a safe outreach: its a great way to get someone directly into service that may or may not make the call.

The new clinic at the community center will be open on Tuesdays.

Continue reading here:
MetroHealth, LGBT Center of Greater Cleveland Partner On New Clinic Opening Tuesday - WKSU News

Recommendation and review posted by Bethany Smith

Written by Allison Aubrey Nov. 11, 2019

There's new evidence that mind-body interventions can help reduce pain in people who have been taking prescription opioids and lead to reductions in the drug's dose.

In a study published this month in JAMA Internal Medicine, researchers reviewed evidence from 60 studies that included about 6,400 participants. They evaluated a range of strategies, including meditation, guided imagery, hypnosis and cognitive behavioral therapy.

"Mindfulness, cognitive behavioral therapy and clinical hypnosis appear to be the most useful for reducing pain," says study author Eric Garland, a professor at the University of Utah. The reductions in dose were modest overall, he says, but the study is a signal that this approach is beneficial.

And Pamela Bobb, who lives in Fairfield Glade, Tenn., can attest to the benefits. She's 56 and has endured decades of pain. "Oh, I had been suffering terribly for years," Bobb tells us.

She was born with a malformation in her pelvis that led to pain. Over the span of two decades, she underwent more than a dozen major surgeries, yet none of them gave her relief; each procedure left more scar tissue and nerve damage.

"I felt desperate, " Bobb says. "I didn't feel like I had any control."

She couldn't do basic things such as cook or take care of her family.

"I was completely debilitated," Bobb says. "And when you get to that point, you can't see beyond the pain you're just surviving."

She was put on high doses of opioids to ease the constant pain, but then a few years ago she thought, "There just has to be a better way." Ultimately, she found help at a clinic that specializes in complementary and alternative medicine.

"We offer a variety of things, explains Wayne Jonas, a physician who treated Bobb at the Fort Belvoir Community Hospital Pain Clinic in Fairfax County, Va.

"We offer physical therapy, behavioral medicine, acupuncture, yoga and mind body practices," Jonas says. None of these is a cure-all, he adds, but the idea is that there are lots of tools in the toolkit for people to try.

Jonas is a longtime proponent of an integrated, mind-body approach to treating pain and the author of How Healing Works, a book that describes the science behind these approaches.

He says that when someone is in severe pain, their body's normal defenses are down.

"It bumps up a variety of dysfunctions," Jonas says. Pain increases levels of the stress hormone cortisol and increases inflammatory processes in the body, too. "This starts a continual negative feedback loop that produces more pain," Jonas explains.

It's not a surprise, he says, that techniques such as meditation or yoga can be helpful. "If you engage in a deep mindfulness and relaxation it will counter those stress responses," Jonas says.

Think of meditation as a form of mental exercise.

"It's almost like weightlifting for your brain," says Garland. Just as curling a dumbbell strengthens the bicep, he says, "meditation is almost a way of, sort of curling the dumbbell of the mind to strengthen the mind's self control."

And this can change the way the brain perceives the input from the body. "If you can change the way the brain perceives signals from the body you can actually change the experience of pain," Garland says.

But there's a trick here: Learning to meditate takes time, effort and some training. It's more complicated than swallowing a pill. Pamela Bobb has stuck with it. She has tried a bunch of these alternative mind-body strategies, including acupuncture and biofeedback, and now starts every morning with a meditation practice.

"It's 4:45 in the morning and I've just awakened," she says in a recording she made of her practice, so I could listen in. She sounds centered, and calm. "I'm allowing my body to feel as relaxed as it possibly can."

Bobb has also overhauled her diet, now eating a lot more greens, fruits and vegetables and herbs and spices with anti-inflammatory properties. On the day we talk, she's making a spinach saute with ginger, mint and rosemary.

"I swear you can smell each of those spices. They smell so good!" she says.

Bobb is so at ease now that, just hanging out with her, you'd never guess all that she has endured. And she feels so much better, she says.

"It's empowering to [have] come all this way," Bobb says. She says she's made a fundamental transition in her mind: Instead of waiting for doctors to heal her with surgeries or injections, she now realizes that many of these alternative therapies have empowered her to help herself.

"So much of it does lie within me," she says.

Bobb accepts that she may never be completely pain-free, but now feels she has control over the discomfort.

She has reduced her opioid dose by 75%. She says she still benefits from a small maintenance dose of the medication. And her doctors say that for her, the benefits of the medicine outweigh potential harms.

In the midst of an opioid epidemic, Bobb's story may seem unlikely. But many people who have taken opioids for a prolonged period have similar stories. And last month, the Department of Health and Human Services released new guidelines urging doctors to take a deliberate approach to lowering doses of opioids for chronic pain patients.

The guidelines point to the potential harms of forcing patients off the medications.

"The goal is not necessarily to get off of all opioids but to reduce it to a dose [that is] safe," Adm. Brett P. Giroir, a physician and assistant secretary for health at HHS, told NPR. We asked him about Bobb's case. He is not her doctor, but after hearing her story he said, "The fact that she's been able to reduce her opioids substantially is a success story."

Giroir says this kind of comprehensive approach that includes alternative therapies "could be a model for what we want to do nationwide." He points out that earlier this year, the Centers for Medicare & Medicaid Services proposed covering acupuncture for Medicare patients who have chronic lower back pain.

As the evidence accumulates, Giroir says, there will be more attention placed on covering alternative therapies.

A 2017 Gallup Poll found that 78% of people would prefer to try other ways to address their physical pain before they take pain medication.

And doctors groups such as the American College of Physicians recommend that doctors offer more nonpharmacological treatments to pain patients, such as those who have chronic lower back pain.

Yet, a paper published last year finds that most insurers have not adopted policies that are consistent with these guidelines, and many don't pay for coverage of these services. An accompanying editorial argues that it's time for that to change.

It's clear that when it comes to tackling pain, it takes all of the tools in the toolkit. And when it comes to opioids, the approach needn't be all or nothing. Bobb says she has learned that, for her, the combination of medicine plus mind-body therapies works best.

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Even if youve taken the abortion pill, you can still change your mind, proclaims the website of a group called Alternatives Pregnancy Center.

The center offers what it calls abortion pill reversal, a treatment it claims can stop a medication abortion thats already been started. Many organizations around the country are beginning to offer the procedure, and a growing number of states require that patients seeking abortions be told about it.

But theres a problem. All of the evidence that we have so far indicates that this treatment is not effective, Daniel Grossman, an OB-GYN and the director of Advancing New Standards in Reproductive Health, a research group at the University of California San Francisco, told Vox.

Pioneered by an anti-abortion doctor in California, abortion reversal involves taking the hormone progesterone after the first dose of abortion medication. However, reproductive health experts, including the American Congress of Obstetricians and Gynecologists, say theres no evidence the procedure actually works to stop an abortion from happening. And, they warn, no one knows what the side effects might be of taking progesterone in an effort to reverse abortion medication.

But Republican-controlled state legislatures are increasingly passing bills requiring doctors to tell patients about the possibility of abortion reversal. The latest is Ohio, where the state Senate passed such a bill last week; the legislation now goes to the state House for consideration.

Anti-abortion groups argue that progesterone is safe and the laws are just a way to make sure patients are aware of their options. But reproductive health advocates say pregnant people around the country are essentially becoming test subjects in an unscientific and unethical experiment.

Its one thing when states were forcing abortion providers to give information that was inaccurate about the risks associated with abortion, Grossman said. This takes it to a whole new level.

Typically, a medication abortion works like this: The pregnant patient takes a pill, called mifepristone, meant to stop the pregnancy from progressing. Then, up to 48 hours later, the patient takes a second pill, misoprostol, that induces contractions and causes the uterus to empty. Mifepristone has been FDA-approved since 2000, and the procedure works to end a pregnancy about 95-99 percent of the time.

But in 2012, Dr. George Delgado, a family medicine physician in San Diego who identifies as pro-life, announced that he had developed a method to reverse the process, according to NPR. If patients changed their minds about the abortion after taking mifepristone but before taking misoprostol, he said, taking progesterone could help the pregnancy continue.

In a paper published that year, he said that of six patients who had received progesterone injections after taking mifepristone, four were able to continue their pregnancies.

When his research came to the attention of anti-abortion advocates, states around the country started passing laws requiring doctors to tell patients that medication abortions could be reversed. The first, Arkansas, passed its law in 2015, and such laws are now on the books in at least eight states, though courts have blocked enforcement in some. Five states including Arkansas, which expanded its requirements have passed laws this year alone, according to HuffPost.

Ohio could become the sixth the bill passed the state Senate last Wednesday and now heads to the House, where Republicans have a majority. The states Republican governor, Mike DeWine, has signed abortion restrictions in the past, including a ban on the procedure after about six weeks gestation, which has been blocked in court.

Abortion opponents and groups identifying as pro-life argue that abortion reversal laws are necessary to make patients aware of their options.

Women should be given full, informed consent when they are considering an abortion, Ingrid Skop, the chairman-elect of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), told Vox.

Because the abortion pill regimen can be reversed, she said, they should be given that information.

But many medical experts say theres no evidence that progesterone does anything to reverse abortion. In a 2017 statement, the American Congress of Obstetricians and Gynecologists said that Delgados 2012 paper, involving just a handful of patients, was not scientific evidence that progesterone resulted in the continuation of those pregnancies.

As the group noted, mifepristone on its own does not always work to end a pregnancy, with up to half of patients who take mifepristone alone remaining pregnant. Thats why mifepristone is prescribed with misoprostol to complete an abortion. So its possible that Delgados patients who remained pregnant would have done so regardless of whether they received progesterone.

In 2018, Delgado published another paper, this time looking at the effect of progesterone on 547 patients who took it after taking mifepristone. He found that in 48 percent of cases, the patient went on to have a live birth, with the rate going up to 64 percent if the progesterone was administered by injection.

Critics, however, point out that this paper was not published in a mainstream scientific journal but rather in Issues in Law and Medicine, a journal that has featured anti-abortion legal analysis as well as articles promoting the debunked theory of a link between vaccines and autism, as Rewire.News reports.

And according to Grossman, the design of the research may have inflated the success rate of the treatment. Some providers involved only prescribed progesterone after an ultrasound confirmed that the pregnancy was continuing, meaning that people for whom mifepristone didnt work well to begin with may be overrepresented in the data.

In addition, Grossman said, its not clear from the paper whether patients were informed that the treatment was experimental. Delgado has not responded to Voxs request for comment, but he told NPR that before his 2018 paper, he told patients that abortion reversal was a novel treatment. Now, he says, we have a substantial amount of data. There is no alternative. And its been proven to be safe, so, why not give it a chance?

Progesterone is sometimes prescribed during pregnancy for other reasons, like to prevent premature labor in the second and third trimesters, Grossman said. But theres no data on whether its safe to give after mifepristone or to take throughout pregnancy, as reversal patients are sometimes advised to do.

The impact on patients of mifepristone combined with high doses of progesterone is virtually unstudied, Kathryn Eggleston, medical director of the sole abortion clinic in North Dakota, wrote in an affidavit obtained by HuffPost. Researchers do not know, she said, whether the combination could cause birth defects, for example.

Moreover, as Grossman noted, the prescription of an unproven treatment to pregnant women has disturbing echoes in Americas past. We know that abortion patients are more likely to be women of color and low-income women, he said, and these are populations that have had research performed on them that was clearly unethical. For example, in the 19th century, Dr. J. Marion Sims conducted gynecological research, including operations without anesthesia, on enslaved women.

However, there are researchers working on a study of abortion reversal designed to meet ethical and scientific standards. Mitchell Creinin, an OB-GYN and professor at the University of California Davis, is conducting a controlled study of progesterone treatment that has been approved by an institutional review board, according to NPR. The results should be available next year.

For now, though, abortion providers say laws like the one proposed in Ohio will hamper their ability to ethically care for pregnant people.

Abortion reversal is unproven, unscientific, and potentially unsafe, Tam Nickerson-Scott, clinic operations director at Preterm, Ohios largest abortion provider, told Vox. We certainly dont want to give out false information to our patients.

Its not clear how many people are currently being prescribed abortion reversal in the United States. But Skop, the AAPLOG chair, believes it is very common and says that most pregnancy resource centers facilities that offer counseling with an anti-abortion bent, also called crisis pregnancy centers offer the procedure. Obria, an anti-abortion group with facilities around the country that recently received a federal family planning grant from the Trump administration, advertises the procedure on its website.

Its also not clear how patients who do get progesterone treatment pay for the medication. Unproven treatments are typically not covered by insurance, Grossman noted. Skop said that patients sometimes pay for progesterone out of pocket and that sometimes pregnancy centers may cover the cost.

Meanwhile, one of the biggest questions around abortion reversal is how many people really want to undo their abortions once theyve started. Some say the number is significant. Women do regret their abortions, said Skop. Ive been practicing for 23 years, and Im also the board chairman of a pregnancy resource center, and we see it frequently.

However, research shows that most patients are actually quite sure about their decisions to have an abortion. One recent study found that, on average, abortion patients were as or more sure of their decision to have an abortion than people facing other medical procedures, such as knee surgery. Another found that 95 percent of abortion patients did not regret the procedure.

But its possible that abortion reversal laws could actually lead to more regretted abortions. In her affidavit, Eggleston, the North Dakota provider, wrote that abortion reversal laws could encourage people to get medication abortions before they are ready to do so, by giving them the mistaken impression that the procedure can be easily reversed if they change their mind.

For Nickerson-Scott, meanwhile, the Ohio bill just causes more hurdles in a state where patients already have to go through a 24-hour waiting period and a total of three doctors appointments to complete a medication abortion. Instead, Ohio patients deserve autonomy over their bodies, she said. We have to trust people that they are the expert of their lives.

I have never heard anyone who has come through our doors and who has told me that they have regretted their abortion, Nickerson-Scott said. What I do hear is, Thank you for being here.

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Around age 3, Luna Younger started asking to wear dresses. Since the age of 5, she has insisted she is a girl. Now Luna is 7, and during court hearings, physicians, school staff, and family members have all testified that Luna has consistently, persistently identified as a girl.

While Lunas mother respects her daughters gender identity letting her wear what she chooses, whether its nail polish, dresses, or longer hair Lunas father does not. He insists Luna is not transgender. These polarizing differences over how to raise and treat a child are why trans families and advocates, as well as conservatives, have been closely watching the custody battle over the Coppell, Texas, trans girl.

After 15 months in court, on October 22, the jury awarded Lunas mother, Anne Georgulas, full conservatorship of her daughter. It was a decision that brought relief to the trans community and outraged conservatives who believe supporting a trans childs gender identity is tantamount to child abuse.

People were so riled up online, some sent threats to Georgulas; she was viciously attacked and threatened by complete strangers, her attorneys told the Daily Caller. Several prominent Texas officials even added to the fray, including Republican Gov. Greg Abbott, who promised to order the states child protective services to investigate Georgulas. State Rep. Steve Toth said he would propose a bill to add Transitioning of a Minor as Child Abuse.

Two days after the debate boiled over online, Judge Kim Cooks decided to vacate the jury decision. Instead, she granted the parents joint managing conservatorship, which is the equivalent of joint custody in Texas. (Cooks has maintained that she did not make her decision based on any government officials opinion; she has not responded to Voxs request for comment.) While Georgulas, a pediatrician, had requested that the court order Lunas father, Jeffrey Younger, to respect their daughters gender identity, Cooks said that the Court finds that the State of Texas has no compelling interest to justify such interference.

The ruling has brought more questions than answers: When one parent honors her childs gender identity and the other does not, what does that mean for the child? More specifically, what will it mean for her socialization, her mental well-being, and who shes allowed to be?

Trans advocates say Cookss decision is a dangerous misstep. Transgender children are among the most vulnerable members of the next generation, Gillian Branstetter, media relations manager at the National Center for Transgender Equality, told Vox. We know they experience any variety of godawful barriers to their own success, including bullying and harassment, including psychological distress, often resulting from such harassment, [and] family rejection. It does a serious disservice to those kids to give any incentive for a parent to reject their child for who they are.

On Tuesday, Georgulas filed to appeal the judges ruling, according to a press release from a family representative. The mother is asking Cooks to recuse herself after allegedly posting about the case on her personal Facebook while deliberations were ongoing. This is after the judge had placed a gag order on Georgulas and Younger from commenting about the case, acknowledging that the publicity from it was affecting Lunas and her twin brothers privacy and well-being. (Georgulas and Younger are still currently under gag order; Youngers attorney did not return Voxs request for comment.)

Since the verdict, a representative for Georgulas, Karen Hirsch, said that a rock was thrown through a window at Georgulass house while the children were sleeping and that Georgulas has been forced to close her pediatric practice after dead animals and graffiti were left outside the door. Meanwhile, parents in Lunas neighborhood are afraid to send their children to class after Younger had named the school online they feel their children could be in danger from those trying to attack Luna.

The case has hit a boiling point where lives feel threatened and trans families inside and outside of Texas feel unsafe all over whether a child should be allowed to wear a dress and be called she and her.

The legal battle over Luna and, ultimately, how she is allowed to identify reached a tipping point in August 2018 when Georgulas filed for a restraining order against Younger, specifically seeking to prevent him from entering Lunas school and telling people that the gender of Luna is different than a girl named Luna.

In response, Younger petitioned for full conservatorship that same month. Up until this point, he had been allowed to see his kids once a week for two hours and on the first, third, and fifth weekends of each month since 2017, though court testimony indicates he frequently skipped his visitation days. He also launched a social media campaign to save his child from the supposed harm of transitioning. For a child of Lunas age, this is solely social and consists of keeping her hair long, choosing her own clothing, and using a feminine name and pronouns.

However, the conservative campaign spread incorrect fears that Georgulas was seeking to immediately chemically castrate the child a misinformed, scary-sounding reference to hormone medications that would suppress Lunas testosterone production and replace it with estrogen, which would typically be years in Lunas future, according to standard medical guidelines. The only plans Georgulas had, according to court transcripts, was to take Luna to a Childrens Health clinic for transgender kids in Dallas. There, they would discuss a plan for potentially starting her on puberty blockers, which are reversible, in the next few years if Lunas gender dysphoria persists. (The clinic did not return Voxs requests for comment.)

Seizing on Youngers narrative of Georgulas manipulating her child, right-wing media outlets like LifeSiteNews and the Daily Wire also accused Georgulas of forcing Luna to be transgender because she wanted a girl. But that claim seems rather flimsy because Georgulas has two older daughters from a prior marriage.

In court testimony, Georgulas said that she would prefer if Luna were not transgender, but she supports her childs gender identity regardless of her own feelings. From my knowledge as a pediatrician and also from the research Ive done, it is better to affirm for the psychological well-being of the child [doctors recommended] that we affirm the childs choices, whatever those choices are, she said.

Meanwhile, Younger made the conservative media circuit rounds, insisting it was Georgulas who was forcing Luna to present as a girl. Luna presents as a boy with me and [she] presents as a girl with his mom, Younger told LifeSiteNews, a conservative Christian website, in September. [She] gets dressed as a boy at [her] mothers home and [she] comes out to me as a boy. That means that [shes] comfortable as a boy at [her] mothers home. Georgulas and others who have testified have disputed this latter part, saying it was Younger forcing Luna to present as a boy.

Maternal blame appears to be common when it comes to trans children of estranged couples. While data on the number of trans children involved in custody disputes doesnt yet exist, a Family Court Review study released earlier this year examined the cases of 10 divorced mothers who affirm their childs trans- and gender non-conforming identities. In each of the 10 cases, the childs father blamed the affirming mother for causing the child to be trans, and courts gave a favorable ruling to the father in four of those cases. However, parents probably have little or no influence on the childs core feelings that define him or her as gender typical or gender variant, the study said.

Overall, conservative media has used the custody case to not only bash transgender people (When they come for your kid blared a headline in the American Conservative, which was followed by a roundup of disinformation), but to demonize a mother and small child. It has resulted in threats, harassment, and even vandalism of my clients property, attorneys for Georgulas told the Daily Caller in a statement.

Despite how the far right has painted Georgulas, it is Youngers character that has come under legal scrutiny. According to court documents of the annulment of his and Georgulass marriage, the court found that Younger lied about multiple aspects of his life: his career, his previous marriages, his income, his education, and even his military service. It was enough for a Texas court to annul their six-year marriage because it was entered into under fraudulent terms.

Judge Cooks also called out Younger for profiting off a violation of his familys privacy. The father finds comfort in public controversy and attention surrounded by his use of unfounded facts and is thus motivated by financial gain of approximately $139,000 which he has received at the cost of the protection and privacy of his children, she wrote in her judgment, referring to a crowdfunding and merchandising scheme launched last year by Younger.

Even conservative pundit Glenn Beck expressed concern over Youngers past. On his radio show, he read the courts findings of fact showing that Younger acted aggressively toward Georgulass older daughters, withholding their possessions, locking them in their rooms, and forcing them to do plank push-ups until they agreed to follow house rules.

That aggressiveness was also directed at Luna, according to Georgulass attorney Kim Meaders. [Luna] has said to CPS that she is afraid of her father, she said in her opening statement. Her brother has said that she is sad and her father makes her sad. By making her dress in boys clothes, that makes Luna sad.

Perhaps the greatest falsehood of all, according to official court records, is that Luna hasnt been clear about how she identifies.

According to a transcript of a July 10, 2018, hearing in the case, Lunas twin brother, a CPS worker, a therapist, and a pediatrician all attest to Lunas gender identity as a girl. The medical professionals who have seen Luna have recommended she be affirmed and treated as a girl, and its Younger who refuses to accept his childs gender identity.

In April 2017, Luna asked to be referred to by the name Luna. At age 5, Luna was diagnosed by a qualified professional therapist as having gender dysphoria, distress stemming from a mismatch between her birth sex and her gender identity. Her pediatrician noted that at both her 5-year and 6-year checkups, Luna presented as a girl and has been persistent in her gender identity throughout her childhood.

The father doesnt follow the recommendations of the counselor or the pediatrician, and he shames her to try to make her feel bad for wanting to dress as a girl, Meaders, Georgulass attorney, told the court. Even though the father knows she wants super-long hair, he shaves her head when he has the opportunity and leaves the other twin boys hair long, referring to her twin brother Jude.

It is the hair-shaving detail that stands out as especially cruel to trans people and advocates. Lunas father has been very insistent on cutting her hair extremely short, and that is like one of my daughters biggest dysphoric points, Jane, a Dallas-area mother of a trans kid who knows Luna (and whose name has been changed for this story) told Vox. For her, all of this is about the fact that Luna is being forced to have short hair. She doesnt understand all the other ramifications.

Lunas hair figures so prominently in this case because at age 7, hair is often the only differentiating physical indicator of a childs gender. Clothed, boys and girls bodies at that age are essentially the same, having not yet undergone any effects from puberty. A trans child at age 7 does not make permanent changes to their body, despite what Younger claims Georgulas wants to do.

Ultimately, the dispute at this current stage and several years into the future is over Lunas social transition: how she wears her hair, what clothes she wears, her name, and pronouns.

There is no medical intervention of any sort prior to someone hitting puberty, Dr. Joshua Safer, executive director at the Center for Transgender Medicine and Surgery at Mount Sinai and president of the United States Professional Association for Transgender Health, told Vox. So small children do not get medicines and small children do not get surgeries, for sure.

The standard approach when kids are gender expansive when they say theyre transgender, when they think theyre transgender, whatever that might happen, to get a clue that this might be going on is pretty much to listen to the kid and to kind of follow their guidance in terms of what they want to do, what the child wants to do, he added.

Safer says its important to develop an individualized plan for mental and physical health for gender dysphoric kids and adolescents. Varying degrees of family support for transition means coexisting mental health issues are important to examine for any trans child; theres no one-size-fits-all solution for all kids. Most of all, the child must feel comfortable with the plan.

Genecis, the Childrens Health clinic where Georgulas wanted to Luna to receive care, makes it clear on its website that it does not perform gender-related surgeries. In providing comprehensive, age-appropriate mental health and hormonal care for trans youth and adolescents, it follows established guidelines from major medical associations in its treatment. The jurys decision, before it was overruled by the judge, would have allowed her to Luna to receive care at the clinic without Youngers approval. Now she wont be able to.

According to court transcripts, Younger had missed several appointments with medical professionals who have worked with Luna, claiming to want opinions from other providers. However, at the time, he hadnt followed through on those requests.

Boiling under the surface of the custody battle is a medical dispute over how best to treat and support children with gender dysphoria. Younger claimed in court that he supports the watchful waiting approach to dysphoric youth. Watchful waiting wasnt given its name until 2012, but its based on an older approach developed by Dutch and Canadian clinicians in the mid-to-late aughts that suggests that parents must ensure their children perform the role of their assigned sex at birth.

Under watchful waiting, a prepubescent trans girl like Luna would be forced to maintain short hair, wear stereotypical boy clothes, form friendships with boys her age, maintain her birth name and pronouns under the belief that its statistically likely that her dysphoria will desist by the time puberty begins. If Lunas dysphoria does persist, only then would she be given puberty blockers, so she can mature before making a more permanent decision on hormone treatment.

Political forces opposed to social transitions for children are fond of saying let kids be kids but watchful waiting seems counterintuitive to that goal.

Watchful waiting is a deceptive term, said Kelley Winters, a writer and consultant on issues of gender diversity in medical and public policy, told Vox. Theres nothing neutral. Its meant to sound effectively neutral, and theres nothing neutral about forcing trans kids to spend their childhoods in the closet and grow up with absolutely no memories of being authentically present in their entire childhood.

The approach is based on older statistics that as many as 80 percent of children with gender dysphoria will eventually desist and grow into cisgender adults. But those numbers, according to Safer, are flawed.

In terms of that desistance 80 percent comment, thats an old Dutch study where they didnt ask the blunt question about your gender identity to these kids, he said. They kind of danced around the topic with a bunch of other questions and kind of assumed they knew the gender identities, but I dont know that it shows much of anything. It just shows that 80 percent of kids who answer questions in a stereotypical way, that you think might be associated with gender identity, end up not being transgender. But theres a lot of bias in the questions.

At issue is the fact that when the Dutch and Canadian studies were conducted, the official diagnosis for gender-variant kids was gender identity disorder. In order to be diagnosed with GID, a child merely had to display cross-gender dress or behavior, regardless of whether they declared themselves to actually be a member of the opposite sex. The effect of this diagnosis is that cisgender gay and lesbian children, who also frequently display cross-gender preferences without declaring themselves to be the opposite gender before puberty, were caught up in the clinicians studies and so of course they would desist later on.

Even Thomas Steensma, a researcher and clinician at the Center of Expertise on Gender Dysphoria in Amsterdam and a proponent for watchful waiting, has noted the earlier samples may have included milder cases that are hard to compare with the clinical samples we see now in our clinics, in an interview with KQED last year. But he still urged caution with social transitioning of prepubescent children. With certain steps like a name change or a pronoun change, with a result that maybe others will only perceive you as a girl thats somewhere where we say, Okay, maybe you should explore things without taking steps that are hard to reverse. (Steensma hasnt returned Voxs request for comment.)

In 2012, gender identity disorder was changed to the less stigmatizing term gender dysphoria, distress resulting from a mismatch between the childs natal gender and their internal sense of their gender identity. Nowadays, in order to qualify for a gender dysphoria diagnosis, the child must be persistent, insistent, and consistent in their gender identity over a long period of time, criteria that didnt exist under the older diagnosis.

Similarly, watchful waiting as a concept has been pushed to the fringes in American medicine as of late, as it is seen as needlessly punitive to the child. Instead, whats more commonly recommended is the affirming method, which allows gender-expansive children to more freely experiment with their gender expression, trying on new names or pronouns as needed. Its an individualized approach without permanent outcomes. Rather than attempting to fix a prepubescent childs perceived gender-related disorder, the affirming approach, which recommends social transitioning if the child wants it, seeks to lessen the actual dysphoria experienced by the child without medical treatment.

The affirming model has been recommended by nearly every major American medical association, including the American Academy of Pediatrics, the American Medical Association, the American Psychological Association, the Endocrine Society, the World Professional Association for Transgender Health, the American College of Obstetricians and Gynecologists, and many others. What is most important is for a parent to listen, respect and support their childs self-expressed identity. This encourages open conversations that may be difficult but key to the childs mental health and the familys resilience and wellbeing, wrote Jason Rafferty, a doctor at Hasbro Childrens Hospital in Providence, Rhode Island, and a professor at Brown University, in a key AAP statement on affirming the gender identities of trans youth released last October.

The kid isnt going to brainwash him or herself into being transgender [if their gender identity is affirmed], Safer said. Theyre going to say how they feel and you can pretty much be respectful and they wont be railroaded into anything, which I think is the anxiety that people still have, and there was some anxiety in the past in the medical establishment, but I think the medical establishment is getting more and more comfortable that that does not seem like a likely event.

Critics of the affirming model fret that cisgender kids may unknowingly get caught up in a gender transition that they will later come to regret, but according to Safer, the key is to be cautious and keep communication open with kids. The ones who are sure of themselves will continuously tell you so.

Safer has said that within his previous practice in Boston and his current one in New York City, hes seen less than 1 percent of his own patients, among several hundred cases, end up desisting. We certainly dont want to be taking transgender kids and not treating them because we know were not perfect in our understanding, he said. There are opportunities, again, to go slow and theres a real range. The kids who are certain of their gender identity, those are not the kids who come back 10 years later and say that it was wrong to do the treatment.

According to a 2016 University of Washington study of 73 children with gender dysphoria, trans kids who are affirmed in their gender identity showed typical rates of depression and only slightly elevated rates of anxiety compared to their non-transgender peer groups. These findings suggest that familial support in general, or specifically via the decision to allow their children to socially transition, may be associated with better mental health outcomes among transgender children, the study said.

Meanwhile, a 2018 study shows that using a trans childs chosen name and pronouns significantly reduces suicide risk.

By the time Luna persists to the stage where her family would need to consider puberty blockers, which according to Georgulass testimony is sometime between the ages of 9 and 11, she would have been persistent, insistent, and consistent in her gender identity for at least six years, with another two or so years to go before having to make a decision about whether to pursue puberty as a girl through the use of cross-sex hormones.

While puberty blockers merely act as a pause on an adolescents natal puberty, cross-sex hormones would be used to initiate the puberty of the opposite sex if the teens dysphoria still persists. Blockers are a tool to keep permanent changes from natal puberty from taking place so that adolescents age 9 to 14 can be more mentally mature before deciding on the course of their permanent treatment when the time comes, according to Safer. Cross-sex hormones would mean testosterone injections for trans boys and a combination of a testosterone blocker in addition to estrogen for trans girls. Safer says its a careful and cautious system that also respects the autonomy young trans people should have over their own lives and bodies.

However, ultra-conservatives and trans-exclusionary radical feminists, along with some extreme sexologists, have other ideas for those childrens futures, lobbying to ban puberty blockers and cross-sex hormones for all minors. While theyve tried to appropriate the watchful waiting description, their approach is more traditionally known as the reparative method, a form of conversion therapy. They appeal to the fallacy that natal puberty is natural and therefore necessary for all kids.

But this approach would force trans girls into male puberty and trans boys into female puberty without their consent, and brings along its own permanent changes, which could only partially be reversed through painful and expensive medical treatments in adulthood. Trans women forced through male puberty would then have to undergo painful and expensive electrolysis to remove facial hair and may be left with a body frame (shoulder and hip width) that would be unchangeable by any surgeries. Trans men would have to have surgery to remove their breasts and, like their trans female counterparts, be forced to live in an unwanted body frame for their entire lives.

Then there are the repercussions of depriving adolescents of social transitioning. Forcing trans people to wait until adulthood deprives them of a childhood where they can be their full selves. Gendered socialization is also missed, dumping adult trans people into a new gender role without the experience to handle delicate gendered social situations such as dating or employment. Trans women are often perceived as too aggressive after transitioning in the workplace, thanks to sexist gender expectations. Allowing for an earlier social transition would let trans adolescents learn how to handle these situations on the same time scale as their cisgender peers.

However, those most invested in maintaining a strict gender dichotomy are the same crowd thats ardently opposed to the existence of trans people, especially trans kids.

Beyond the larger questions over how to treat gender expansive and dysphoric children, the Luna Younger case serves as yet another battleground in the conservative war against the transgender community at large. What concerns Jane, the Dallas-area parent of a trans child, though, is how powerful state and federal officials have taken aim at individual trans children in order to push their political agenda.

Im really concerned about what this looks like moving forward in politics that our politicians here in Texas, our legislators that are supposed to be protecting all children, are explicitly targeting a 7-year-old for their own political gain, she said. Thats really frightening that theyre stooping to those levels.

In addition to Governor Abbott, Texas Sen. Ted Cruz and the presidents son, Donald Trump Jr., a frequent commenter on trans issues, also chimed in on the case, both calling Lunas transition child abuse.

Riding the wave of conservative outrage, Texas legislator Matt Krause has floated the idea of banning the use of puberty blockers in gender dysphoric children in the state, a move which, if replicated in other states, could rip thousands of adolescents off of gender-affirming treatment and force trans girls like Luna to develop facial and body hair in addition to stereotypically male secondary sex characteristics without her consent. Or it could force her to travel hundreds of miles out of state to seek the same treatment.

Fellow Republican legislator Steve Toth promised on Twitter that the first bill in the next legislative session in 2021 would aim at designating affirming a trans childs gender identity as child abuse under state law. This would mean the state would legislate the clothes, name, and hair of a child.

The movement against trans kids has also spread beyond Texas state lines. Early last week, Georgia Republican state Rep. Ginny Ehrhart proposed the Vulnerable Child Protection Act, which would make it illegal for medical providers to consider any treatment which would result in sterilization, mastectomy, vasectomy, castration and other forms of genital mutilation, many of which are not treatments considered for trans adolescents. However, Ehrharts bill would also ban puberty blockers and cross-sex hormones for every individual under the age of 18. A similar bill has also been floated by a Kentucky state lawmaker following the Younger case.

Among the disinformation tossed around by conservative media recently was a report that the puberty-blocking drug Lupron was responsible for the death of thousands of people. However, an NBC News report on the controversy found that the drugs primary usage is to treat hormone-dependent cancers such as terminal prostate cancer and the drug was used as part of treatment and was not the cause of death in those cases.

Branstetter said that the Younger case in particular is dangerous because its so personal for one family. This has been a constant disinformation war amongst a legion of conservative media sites that has sought to disparage transgender people and to fear-monger about our health care, she said. To play into those hands, as the governor has done in this case, its exploitative. It is using a family and a child as a means to score political points and youre doing so without their consent.

Jane said the attention to the case has given her serious doubts about her public advocacy as a parent of a trans child in Texas. She has hired IT professionals to monitor her familys tech and installed additional security cameras around her house. Its been really, really stressful, intense, she said. And lots of tears, lots of sleepless nights. And lots of phone calls from other people figuring out how they can support this family.

Already, the attention from state and national conservative politicians has had a chilling effect on trans-supportive parents. Several Texas-based parents of trans kids declined to speak with Vox for this story because they were specifically afraid of the governor calling CPS on them. Branstetter notes that many parents of trans kids keep whats called a safe book, which documents every instance of observable gender dysphoria and every medical and psychological appointment because strangers who disagree with allowing children to socially transition often call CPS with accusations of child abuse. One clinician who was approached for an interview for this story had been told by their institution not to comment for a piece that mentioned ongoing litigation.

While Texas families with trans kids fear official government retaliation for supporting their childrens transitions, the family at the center of the case is left to deal with the fallout. Lost in the media frenzy and the court dispute has been Lunas own voice on the matter. In her young mind, what this boils down to is she thinks that all of this court stuff is so she doesnt have to cut her hair anymore, Karen Hirsch, a family friend of Georgulas who is acting as a media contact, told Vox. Thats what it comes down to for her. She just wants to be a girl. She doesnt want all of [this] conflict.

As of last week, Judge Cooks granted Younger an extra school day of custody a week. Hirsch said that Younger dressed Luna as a boy and sent her off to class on Tuesday. When she arrived, the teacher had extra clothes and said that if you want to change, you may change, Hirsch said.

And when mom and dad werent around and couldnt influence Luna one way or the other, what did she choose to do?

Hirsch said Luna chose to wear the dress.

Read the original:
The battle over Luna Younger, a 7-year-old trans girl in Texas, explained - Vox.com

Recommendation and review posted by Bethany Smith

Across 2019, Vertex has struck deals intended to yield a new generation of breakthrough medicines.

In June, Vertex agreed to pay $245m (220m) upfront to acquire Exonics Therapeutics for its gene editing technology and pipeline of programs targeting diseases including Duchenne muscular dystrophy (DMD). Months later, Vertex put up another $950m to buy Semma Therapeutics and its cell therapy treatment for type I diabetes.

The acquisitions moved Vertex, which started out in small molecules, into new areas, and building out capabilities in those areas will cost money.

In recent years, Vertex has grown its annual operating expenses by 10% to 14%. Talking on a recent quarterly results conference call, Vertex CFO Charles Wagner warned investors to expect costs to rise faster in 2020.

Wagner said, Our current expectation is that the rate of growth will be somewhat higher in 2020 as we invest in research and preclinical manufacturing for selling genetic therapies in support of our programs in type I diabetes, DMD and other diseases.

The move into type I diabetes also takes Vertex into territory that, to some observers, looks different than the areas the company has targeted historically.

Asked by an analyst about the shift in focus, Vertex CEO Jeff Leiden downplayed the differences, noting that type I diabetes is treated in the US in a relatively small number ofcenters that can be targeted by a speciality sales force.

Researchers have achieved positive, long-term outcomes by transplanting cadaveric islets into patients but two barriers have stopped companies from industrialising that approach.

Firstly, there are too few cadaveric islets to treat all type I diabetics. Secondly, immunosuppression is needed to stop patients from rejecting the transplanted cells.

Semma is trying to tackle the problems by differentiating stem cells and using a device to protect them from the immune system. Vertex thinks these technologies are the breakthroughs the field needs to industrialize the concept.

Leiden said, We were watching companies who are addressing those two problems for the last two, three years. And over the last six to eight months, we were convinced that Semma has actually solved both of those problems.

Vertex reached that conclusion on the strength of preclinical data. Now, Vertex is set to invest to find out whether the idea works in the clinic.

Read more from the original source:
Vertex invests in gene therapy manufacturing - BioPharma-Reporter.com

Recommendation and review posted by Bethany Smith

Ease of use, fear of the unknown, and healthcare providers advice are all major factors that play a role in whether people with hemophilia want to switch to new treatment options, a small study suggests.

The study, Patient Perspectives on Novel Treatments in Haemophilia: A Qualitative Study, was published in the journal The Patient.

The current standard-of-care for people with hemophilia is replacement of the missing coagulation factors, given via injection. But there are numerous imperfections with these therapies, from the need for frequent injections to the possibility of developing resistance.

In recent years, new hemophilia treatments, including products with longer half-lives and gene therapies, are being developed or entering the market. Although these therapies may be improvements over standard care in some regards, they have drawbacks of their own and since they are newer, some of these issues may not even be known yet.

Still, there exists the possibility that people with hemophilia may want to switch treatment regimens as new options become available. In this study, researchers set out to better understand the factors that influence such a choice.

To do this, they conducted interviews with 12 people with moderate or severe hemophilia, as well as two parents of children with hemophilia. All participants were Dutch, and they represented a range of backgrounds, including different ages, hemophilia types, infection statuses (such as HIV and hepatitis C), and even fear of needles.

The participants generally reported satisfaction with their current treatment methods (all but one were treated at home; one went to the hospital for bleeds), though they acknowledged some challenges, such as the hassle of self-injecting.

Cost was a particular concern; six participants reported avoiding injections when possible to save money even against the advice of their healthcare providers.

When asked how they felt about switching to a new therapy, eight participants said they were open to the idea, but did not feel they urgently needed something different, while three participants all of whom were younger and had few bleeding problems said they didnt feel the need to switch. The two parents said they were adopting a wait-and-see approach.

The researchers summarized factors that participants said would make them more or less likely to switch therapies. Factors in favor of switching included the possibility of the new medication being more effective and being easier or more convenient to use.

If I had to switch to a different medication, I would switch to one with a longer half-life. That would be a bit better for me so I have to inject less often, one participant said.

However, participants expressed a general fear of the unknown and a reluctance to take therapies that have relatively less research to back them up, saying they didnt want to be a guinea pig or research subject.

There is also the possibility that a new therapy even one that works well in general might not work for a given individual, posing a risk for switching from a treatment that is known to work.

I know two guys that participated in a gene therapy trial. One was out of luck, he didnt achieve higher factor levels. The other one did. Yes, fantastic if it works, said one participant. On the other hand, if you have good treatment, why would you change it?

More broadly, participants expressed confidence that their healthcare providers would inform them if new therapies that would benefit them became available.

The doctors are specialists, one participant said, and at some point theyll say: hey, we have this new treatment for you, so Ill say: sure, bring it on!'

Overall, the study highlights the factors that are important to people with hemophilia who are considering their treatment options.

It is important for hemophilia treatment teams to be aware of these factors in providing information to facilitate shared decision making, the researchers concluded.

Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.

Total Posts: 121

Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Tcnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.

Excerpt from:
Hemophilia Patients, Caregivers Identify Factors in Switching Treatments - Hemophilia News Today

Recommendation and review posted by Bethany Smith

Why choose gene therapy to do research?

Hearing loss is the most common sensory impairment in humans, which, according to statistics, currently disables 466 million people in the world. And the incidence of genetic hearing loss in newborns reaches up to 1. Many cases show that hearing loss is actually related to genetic DNA mutations, and there are nearly 100 genes known to be related, such as GJB2, SLC26A4, 12SrRNA, etc. Mutations in hereditary hearing loss include single nucleotide substitution, base deletion and insertion. These mutations lead to missense and nonsense mutations in the deafness gene.

Thus, selective correction at gene level may serve as an innovative and effective treatment for genetic hearing loss.

How does gene therapy work to heal deafness of mice?

Most cases of genetic hearing loss are result from mutations in DNA. DFNB9 is one of them, which is caused by a mutation in the otoferlin (OTOF) gene. The OTOF gene produces a protein called otoferlin, a component of the sound-sensing hair cells, without which the brain cant receive any sound information.

Before doing clinical research on humans, the researchers of the team used mice as a model of human DFNB9 deafness. Their method restores the normal function of the ear by using viruses and protein that can infect cells and integrate DNA into that of cells. In this study, the researches edited healthy copies of the OTOF gene into an adeno-associated virus (AAV), which is stable and efficient without causing a significant immune response. However, it is quite small and not able to match with huge human genes, so the researchers engineered two different AAV vectors, each containing half of the gene.

The inner ear has a unique advantage in structure for its being relatively easy to touch, but close and filled with liquid, which allows the drug injected into the cochlea to maintain a high concentration in the target organ. The researchers injected these engineered viruses into the cochlea of the DFNB9 model mice and the result showed that this restored communication between the ear and the brain.

What are the advantages and disadvantages of gene therapy?

Gene therapy can restore the normal hearing better because its essentially a method to repair the ear, not artificially simulating the ear. However, gene therapy for hearing loss still faces some challenges, for example, the exogenous genes may not be stably expressed in vivo for a long time, the product of exogenous genes may cause a serious immune response, etc.

At present, most of the research on genetic hearing loss remains in genetic screening, diagnosis and guidance. Further research is needed on the correction of gene mutations, which proves a promising future for gene therapy for genetic hearing loss. As a CRO specializing in gene therapy, Creative Biolabs has a team of experienced scientists and well-treated staff and has established dozens of world-leading platforms. Concentrating on providing a wide range of early development services, such as the gene therapy strategy design, hair cell regeneration, validation & function assessment in vitro and in vivo and other customized services, Creative Biolabs works with worldwide clients to find the best way to conquer genetic hearing loss.

See the original post:
A New Treatment Method May Cure Patients of Genetic Hearing Loss - PharmiWeb.com

Recommendation and review posted by Bethany Smith

LONDON--(BUSINESS WIRE)--The global bleeding disorders therapeutics market size is poised to grow by USD 4.32 billion during 2020-2024, according to a new report by Technavio, progressing at a CAGR of close to 7% during the forecast period. Request Free Sample Pages

Read the 170-page research report with TOC on "Bleeding disorders therapeutics Market Analysis Report by Type (Hemophilia A, Hemophilia B, Von Willebrand disease, and Other disorders) and geography (North America, Europe, Asia, and ROW) 2020-2024".

The market is driven by rising initiatives to increase awareness about bleeding disorders. Also, the emergence of gene therapy is anticipated to further boost the growth of the bleeding disorders therapeutics market.

The market is witnessing rising initiatives by public and private organizations and governments, to increase awareness about bleeding disorders. These actions and campaigns have created awareness about the advances and discoveries in medicine for bleeding disorders in recent years. Organizations such as the National Hemophilia Foundation, von Willebrand Education Network, and World Federation of Hemophilia support are engaged in creating awareness about bleeding disorders. Such awareness campaigns will have a significant impact on the growth of the market during the forecast period.

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Major Five Bleeding Disorders Therapeutics Companies:

Baxter International Inc.

Baxter International Inc. has business operations in various segments, including renal care, medication delivery, pharmaceuticals, clinical nutrition, advanced surgery, acute therapies, and other. The companys key product offerings include FEIBA, HEMOFIL M, RIXUBIS, and Prothromplex TOTAL.

Bayer AG

Bayer AG operates the business under various segments, namely pharmaceuticals, crop science, consumer health, and animal health. Some of the companys key offerings include Jivi, KOVALTRY, and Kogenate FS.

CSL Ltd.

CSL Ltd. manufactures, markets, and develops plasma therapies and conducts early-stage research on plasma and non-plasma therapies. The companys key offerings in the bleeding disorders therapeutics market include Corifact, RiaSTAP, Stimate, Humate-P, AFSTYLA, IDELVION, and MONONINE.

F. Hoffmann-La Roche Ltd.

F. Hoffmann-La Roche Ltd. focuses on the development of drugs in the oncology, immunology, neuroscience, ophthalmology, and infectious diseases areas, as well as other therapeutic areas. The company offers HEMLIBRA, which is a prophylactic treatment for patients with hemophilia A with or without factor VIII inhibitors.

Grifols SA

Grifols SA has business operations under various segments, which include bioscience, hospital, diagnostic, bio supplies, and others. The companys key offerings include ALPHANATE, Profilnine SD, and AlphaNine SD.

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Bleeding Disorders Therapeutics Type Outlook (Revenue, USD Million, 2020-2024)

Bleeding Disorders Therapeutics Regional Outlook (Revenue, USD Million, 2020-2024)

Technavios sample reports are free of charge and contain multiple sections of the report, such as the market size and forecast, drivers, challenges, trends, and more. Request a free sample report

Related Reports on Health Care are:

Hemophilia A Therapeutics Market Hemophilia A Therapeutics Market by product (recombinant therapies, plasma-derived therapies, hormonal therapies, and others), type (on-demand treatment, prophylactic treatment, and inhibitor treatment) and geography (Americas, APAC, and EMEA).

Hematology Analyzers and Reagents Market Hematology Analyzers and Reagents Market by end-users (hospitals and diagnostic centers, blood bank centers, and others) and geography (North America, Europe, Asia, and ROW).

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Global Bleeding Disorders Therapeutics Market 2020-2024 | Evolving Opportunities with Baxter International Inc. & Bayer AG | Technavio - Business...

Recommendation and review posted by Bethany Smith

OTC:GOVX

GeoVax Labs, Inc. (OTC:GOVX) filed its third quarter 2019 10-Q and issued the accompanying press release on November 7, 2019 providing an operational and financial update on the companys performance. During the third quarter and to date GeoVax gave several presentations related to the Lassa fever, HIV and Marburg programs, issued additional shares to satisfy convertible preferred liquidation, further oriented the company towards an oncology focus and announced a partners Investigational new Drug (IND) application for an HIV cure. Looking forward to the rest of 2019, we expect GeoVax will continue to seek additional capital to support its initiatives in immuno-oncology and apply for further grant funding to support the many vaccine programs in development.

Grant and collaboration revenues for 3Q:19 were $215,000, representing a 5% decrease compared to 3Q:18 levels. Revenues were recognized for Lassa fever related to the SBIR and US Army grants, while the Zika SBIR grant has been exhausted. Total expenditures for the first quarter were $759,000, down 25% from prior year levels. R&D expenditures of $0.5 million compared to $0.6 million in the prior year. G&A was $0.3 million, falling 36% from 3Q:18 levels with the decrease primarily attributable to lower levels of stock based compensation.

As of September 30, cash on the balance sheet was $569,000 and notes outstanding were carried at $42,000. Cash burn for the three month period was ($0.3) million, which compares to ($0.3) million in the comparable period. GeoVax received $700,000 in proceeds from sale of preferred stock. Following the end of the quarter, additional convertible preferred instruments were exercised increasing the shares outstanding to 426 million as of November 6, 2019.

Shift to Immuno-Oncology

GeoVax expects to continue to develop its HIV and infectious disease programs with grants and other available funding; but will shift its primary development focus towards immuno-oncology (IO). The company plans to leverage its validated Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform technology to deliver tumor-associated antigens (TAAs) to the immune system so that it may mark cancer cells for destruction. The primary target for the IO program is Mucin 1 (MUC1), which is an oncogenic transmembrane glycoprotein overexpressed in many hematologic malignancies and solid tumors. Some of the cancers that have been shown to overexpress MUC1 include breast cancer, lung cancer and multiple myeloma. GeoVax is seeking support to pursue a triple-combination approach with its MUC1 vaccine, checkpoint inhibitors and standard of care. Preclinical work with GeoVaxs candidate demonstrated a 57% reduction in tumor growth compared to controls when MVA-VLP-MUC1 was combined with anti-PD-1 antibodies. GeoVax will also pursue a second TAA, Cyclin B1, in collaboration with Vaxeal Holding SA. Other partners participating in the oncology collaboration include Emory University and Leidos, Inc., with the latter contributing a PD-1 checkpoint inhibitor to the effort.

Exhibit I MVA-MUC1 Preclinical Model Data1

GeoVax is seeking collaborations with larger pharmaceutical or biotechnology companies or from government or non-profit organizations to support IO development. Due to the greater level of demand for new cancer therapies, GeoVax anticipates that after preclinical validation, funds could be raised to advance IO candidates through the clinic.

GeoVax has formed a separate subsidiary to house the oncology assets, which will allow targeted funding for these programs. All oncology work is expected to be performed in the new subsidiary, with joint development and licensing opportunities available. We expect further details on this structure in future quarters.

Partner IND Submission

Partner American Gene Technologies (AGT) submitted an IND application in mid-October for its lentiviral vector-based gene therapy candidate designated AGT103-T. If the FDA has no questions regarding the filing and does not place a clinical hold, AGT plans to enroll its first patients in January 2020. GeoVax will contribute its MVA-VLP HIV vaccine (MVA62B) to be used as a boost prior to removing T cells from the patient for reprogramming ex vivo. The trial will evaluate the use of AGT103-T alone and in combination with MVA62B. GeoVaxs Dr. Guirakhoo noted that in a Phase I trial the vaccine has stimulated CD8+ and CD4+ T cells in HIV-positive individuals, which suggests added efficacy from the boost.

Infectious Disease Programs

On July 16, GeoVax announced a presentation entitled A Single Dose of MVA-Based Lassa Virus Vaccine Provides Complete Protection in a Mouse Lethal Challenge Model at the Annual Meeting of the American Society of Virology in late July 2019. The topic of the presentation addresses the preclinical efficacy of a novel vaccine candidate for Lassa fever based on an MVA vector expressing two immunogens derived from the Lassa virus. After vaccination, the immunogens stimulate the formation of virus like particles (VLPs) that will develop immunity in the host against subsequent infections of Lassa. The study was funded by a Fast Track Phase I/II Small Business Innovative Research (SBIR) grant to GeoVax from the National Institute of Allergy and Infectious Diseases (NIAID).

In the fourth week of July, GeoVaxs Chief Scientific Officer, Dr. Harriet Robinson, delivered a presentation entitled Protein-Supplemented DNA/MVA Vaccines: Preclinical Immunogenicity and Protection for Transmitted/Founder and CD4-induced gp120 Proteins at the 10th International AIDS Society Conference in late July.

July was a busy month, and before it was over GeoVax reported 100% protection from preclinical challenge studies of its Marburg virus vaccine. GeoVaxs candidate, GEO-EM05, was administered to guinea pigs and compared against a control group. Eight weeks after inoculation, the animals were challenged with Marburg virus. In the active group, all animals survived with no negative health issues while all animals in the control group developed conditions that required them to be euthanized.

GeoVax has offered the infectious disease vaccines to public health agencies worldwide in return for development funding to advance the candidates towards approval. This approach could have benefits as it would further validate the MVA-VLP based vaccine platform and allow the company to potentially attract funds for development of other candidates in the portfolio as well as more quickly making life-saving vaccines available for populations that need them.

Year to Date Highlights

Collaboration with Enesi Pharma to develop vaccines using ImplaVax January 2019

Ebola vaccine study published in Atlas of Science March 2019

Expansion of Leidos collaboration in malaria March 2019

Execution of 500:1 reverse stock split May 2019

Marburg Virus Vaccine Study Results July 2019

Publication of Lassa Fever Study Results for GEO-LM01 September 2019

Presentation at World Immunotherapy Congress October 2019

Presentation at International Society of Virology October 2019

Presentation at World Vaccine Congress October 2019

Exhibit II GeoVax Vaccine Pipeline2

Summary

GeoVax continues to develop programs with a variety of grants while it seeks a partner and funding for later phase development of HIV projects. The company has reoriented its focus towards IO and has identified two targets that are appropriate for further research and combination therapies. GeoVax faces substantial dilution from conversions of its preferred stock and will be focused on identifying sources of investment that may potentially eliminate the additional $2.5 million in preferred stock outstanding. GeoVaxs portfolio has substantial value and company management is focused on identifying funding in order to advance the portfolio candidates. Participation in AGTs HIV trial and an offer from non-profits to develop infectious disease candidates may bring additional attention and validation to the MVA-VLP platform and potentially attract investment funds.

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_________________________________

1. Source: GeoVax Press Release. Leveraging GeoVax's Vaccine Expertise To Take On Cancer, Atlanta, GA, September 9, 2019.

2. Source: GeoVax Website Accessed November 2019. https://www.geovax.com/technology-pipeline/pipeline-summary

Excerpt from:
GOVX: Third Quarter 2019 Results and Update - Zacks Small Cap Research

Recommendation and review posted by Bethany Smith

Gene Therapy Market report has been structured after a thorough study of various key market segments like market size, latest trends, market threats and key drivers which drives the market. This market study report has been prepared with the use of in-depth qualitative analysis of the global market. The report displays a fresh market research study that explores several significant facets related to Gene Therapy Market covering industry environment, segmentation analysis, and competitive landscape. This global market research report is a proven source to gain valuable market insights and take better decisions about the important business strategies.

Industry Analysis:

Global gene therapy market is rising gradually with a healthy CAGR of 36.1% in the forecast period of 2019-2026. Increasing incidence of cancer and rare life threatening diseases and strong clinical pipeline drugs for gene therapy are major drivers for market growth.

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Top Dominating Competitors are: Pfizer Inc., Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, Spark Therapeutics, Inc., bluebird bio, Inc., ALLERGAN, Krystal Biotech, Inc., Amicus Therapeutics, Inc., Sarepta Therapeutics, Novartis AG, MeiraGTx Limited, Rocket Pharmaceuticals, Lonza, Biogen, Gilead Sciences, Inc., REGENXBIO Inc., uniQure N.V., Solid Biosciences Inc., Audentes Therapeutics among others.

Gene Therapy Market Report incorporates the precisely contemplated and surveyed information related to the Gene Therapy Market by utilizing various explanatory tools and techniques. The explanatory devices, for example, PEST analysis, Porters five Forces examination, SWOT investigation, speculation return examination and feasibility analysis have been utilized to break down complex Gene Therapy Market data

Market Drivers and Restraint:

Table of Contents:

Chapter 1 Industry Overview:

Chapter 2 Premium Insights

Chapter 3 Production Market Analysis:

Chapter 4 Major Market Classification:

Chapter 5 Major Application Analysis:

Chapter 6 Industry Chain Analysis:

Chapter 7 Major Manufacturers Analysis:

Chapter 8 New Project Investment Feasibility Analysis:

Chapter 9 Market Driving Factors:

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Geographical landscape

Have look on the Premium Insights of the Report

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The rest is here:
Gene Therapy Market Trends, Technology and Forecast | by Top Companies Novartis AG, MeiraGTx Limited, Rocket Pharmaceuticals, Lonza, Biogen, Gilead...

Recommendation and review posted by Bethany Smith