Phase 3 Trial of ALS Cell Therapy, NurOwn, Gets Thumbs Up in Safety Review by Monitoring Board – ALS News Today
The Phase 3 clinical trial testing BrainStorm Cell Therapeutics cell therapy candidateNurOwn inamyotrophic lateral sclerosis (ALS) patients is continuing as planned after a second safety assessment by the trials independent Data Safety Monitoring Board (DSMB) found no reasons to stop, the company announced.
The DSMBs recommendation comes after a pre-specified interim analysis of the first 106 ALS patients treated repeatedly with NurOwn in this randomized, placebo-controlled clinical trial.
After reviewing all of the safety data as of September 30th, the DSMB has recommended the study continue without any changes in the protocol. We did not identify any significant safety concerns, Carlayne Jackson, MD, a professor of Neurology and Otolaryngology UT Health San Antonioand the DSMB chairperson, said in a press release.
DSMBs consist of research experts who monitor the progress of a clinical trial and review safety and efficacy data while the study is ongoing. This panel can recommend that a trial be stopped early because of safety concerns or evidence a therapy is not working as intended, or if the trials main goals have already been reached.
NurOwn consists of mesenchymal stem cells (MSCs; stems cells able to generate various cell types) collected from a patients bone marrow. These MSCs are expanded and matured into a specific cell type called MSC-NTF by growing them under conditions that induce them to secrete high levels of neurotrophic factors (NTFs) that support the growth, survival, and maturation of nerve cells.
MSC-NTF cells also deliver immune system regulating cytokines, small proteins important in cell signaling or messaging, to sites of damage, BrainStorm reports. It is thought this will help to slow or stabilize disease progression.
The double-blind Phase 3 trial (NCT03280056),fully enrolledat its six U.S. sites, is investigating use of NurOwn in 200 ALS patients whose symptoms became evident within two years of the studys start. Patients are randomized 1:1 to either NurOwn or placebo, given via intrathecal (spinal canal) injection every two months.
The studysprimary measures of safety and efficacy are being determined using the ALS functional rating scale score (ALSFRS-R; a score of abilities like swallowing, speech, handwriting, walking, etc.) in patients after 28 weeks of treatment compared to placebo.
A secondary goal is assessing how biomarkers, such as cell-secreted neurothrophic factors, inflammatory agents, andcytokines, change in the blood and cerebrospinal fluid (the liquid surrounding the brain and spinal cord) after treatment with NurOwn.
BrainStorm is expecting to have topline trial data by the end of 2020, which will potentially support the submission of a Biologics License Application (BLA) to theU.S. Food and Drug Administration requesting approval.
We are very pleased with the DSMB recommendation that the Phase 3 clinical trial continue without any protocol modification. This represents an important clinical trial advancement for BrainStorm and for the development of NurOwn as an innovative cellular therapy approach for ALS patients, added Ralph Kern MD, BrainStorms chief operating officer and chief medical officer.
This clinical trial is being funded by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and other types of investment.
NurOwn was given orphan drug status by both theFDA and the European Medicines Agency (EMA) as apotential ALS treatment.
Iqra holds a MSc in Cellular and Molecular Medicine from the University of Ottawa in Ottawa, Canada. She also holds a BSc in Life Sciences from Queens University in Kingston, Canada. Currently, she is completing a PhD in Laboratory Medicine and Pathobiology from the University of Toronto in Toronto, Canada. Her research has ranged from across various disease areas including Alzheimers disease, myelodysplastic syndrome, bleeding disorders and rare pediatric brain tumors.
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Ins Martins holds a BSc in Cell and Molecular Biology from Universidade Nova de Lisboa and is currently finishing her PhD in Biomedical Sciences at Universidade de Lisboa. Her work has been focused on blood vessels and their role in both hematopoiesis and cancer development.
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Partner Therapeutics (PTx) Announces the Appointment of John McManus as Chief Business Officer – PRNewswire
Mr. McManushas over 20 years of leadership experience in the biopharmaceutical industry that includes leading the transformation of several biotech companies through strategic partnerships and execution of value-based strategies.Prior to joining PTx, John was the CEO of Aeolus Pharmaceuticals, where he managed a $100+ million BARDA contract for the advanced development of a radiation medical countermeasure.Before joining Aeolus, John served in strategic and financial roles at Spectrum Pharmaceuticals where he focused on oncology and NeoTherapeutics where he focused on Alzheimer's, Parkinson's, ALS and spinal cord injury.John holds a B.S. in International Finance and Business Economics from the University of Southern California.
"We are very pleased to welcome John to our team to lead our business development activities," said Bob Mulroy, PTx's Chief Executive Officer. "His breadth of experience as a biotech executive and business leader will be tremendous assets for our team as we continue to build and grow the opportunity for Leukine to help patients in need. We also will benefit from John's extensive experience working with the U.S. government to advance our ability to serve as a partner for a wide range of important government programs."
"I am excited to join the PTx team in strengthening and expanding the Leukine franchise and identifying additional products that would benefit from the Company's development and clinical expertise," said Mr. McManus. "Leukine is a critical drug in the treatment of adults and children facing life-threatening diseases and a key medical countermeasure for improving survival after lethal levels of radiation exposure.I am especially excited about working to support the development of Leukine in new indications like melanoma and diseases of the central nervous system like Alzheimer's and Parkinson's and expanding its use as a medical countermeasure through development partnerships with third parties including the U.S. government.I see tremendous potential for Leukine to help patients across a number of difficult-to-treat diseases."
PTx acquired the global rights to develop, manufacture, and commercialize Leukine in 2018.
Leukine is a multi-lineage immune-stimulant that has been demonstrated to promote growth and activation of monocytes, macrophages, neutrophils and dendritic cells.It is the only FDA-approved recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF). It is currently indicated for the treatment of AML in older adults to reduce the incidence of severe and life-threatening infections resulting in death; use in the treatment of allogeneic bone marrow transplants to reduce the incidence of bacteremia and other culture positive infections and shorten the median duration of hospitalization; to prolong the survival of patients who are experiencing bone marrow transplant failure or delay; and to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
About Leukine(sargramostim)
Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF.GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity3.
Important Safety Information for LEUKINE (sargramostim)
Contraindications
Warnings and Precautions
Adverse Reactions
Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:
Please see full Prescribing Information for LEUKINE at http://www.leukine.com
Indications and Usage
LEUKINE (sargramostim) is a leukocyte growth factor indicated for the following uses:
About Partner Therapeutics, Inc.:
PTx is an integrated commercial-stage biotech company focused on the development and commercialization of therapeutics that improve health outcomes in the treatment of cancer. PTx's development focus spans the entire range of cancer therapy from primary treatments to supportive care. The company believes in delivering great products with the purpose of creating the best possible outcomes for patients and their families.
SOURCE Partner Therapeutics, Inc.
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Partner Therapeutics (PTx) Announces the Appointment of John McManus as Chief Business Officer - PRNewswire
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ExCellThera announces publication in The Lancet Haematology highlighting excellent clinical results of ECT-001 in patients with haematological…
MONTREAL, Nov. 06, 2019 (GLOBE NEWSWIRE) -- ExCellThera Inc., an advanced biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today the publication of full data from the first clinical trial using ECT-001 (single UM171-expanded cord blood) in patients with haematological malignancies. The data were published in the peer-reviewed medical journal, The Lancet Haematology.
The clinical trial findings indicate that ECT-001 cell therapy is feasible, safe (as suggested by the low transplant-related mortality, low incidence of severe acute graft-vs-host disease (GVHD), and absence of moderate to severe chronic GVHD) and allows for the use of small cords without compromising engraftment. In addition, ECT-001 has shown potential to overcome the disadvantages of unexpanded cord blood transplants while maintaining their benefits of low risk of chronic GVHD and relapse. The Lancet Haematology paper provides the first detailed analysis of the study results presented at the 60th American Society of Hematology Annual Meeting (ASH 2018) in December 2018 and supports the recent advancement of the ECT-001 clinical program.
Were pleased that these important results from the first clinical trial using ECT-001 in haematological malignancies are now fully available to the broader bone marrow transplant community, said Dr. Guy Sauvageau, CEO and founder of ExCellThera, and co-senior author of the paper. These results indicate that ECT-001 transplants combine the advantages of conventional grafts using bone marrow (low treatment-related mortality), peripheral blood (fast engraftment) and cord blood (greater accessibility, low relapse and chronic GvHD) in a single, low cost, easy to produce 7-day culture product, which could lead to a paradigm shift in bone marrow transplantation.
The FDA granted ECT-001 Orphan Drug Designation for the prevention of graft-versus-host disease in 2018 and Regenerative Medicine Advanced Therapy Designation in the treatment of hematologic malignancies in 2019. ECT-001 is currently being used for the treatment of blood disorders in other ongoing and approved clinical trials in the United States and Canada. ExCellThera also plans to initiate a European clinical trial as well as a pivotal, multi-centre clinical trial in the coming months.
About ExCellThera Inc.
ExCellThera is an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for use in novel one-time curative therapies for patients with hematologic malignancies, autoimmune and other diseases. ExCellTheras lead solution combines a proprietary small molecule, UM171, and an optimized culture system. In pursuit of better treatments for patients, the company is building out its portfolio of products, as well as supporting best-in-class clinical trials. excellthera.com
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ExCellThera announces publication in The Lancet Haematology highlighting excellent clinical results of ECT-001 in patients with haematological...
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Global Anti-Neoplastic Agents Market: Development History, Current Analysis and Estimated Forecast to 2025 – Market Research Reporting
Antineoplastic is a class of medicine to restrain or kill tumor cells in the body. It plays an important role in comprehensive cancer treatment, particularly for disseminated tumor and leukemia that cannot be treated with surgery. Most current antineoplastics work by inhibiting DNA or RNA synthesis, or even damaging the structure of DNA. Antineoplastics can be divided into CCNSA (Cell cycle nonspecific drug) and CCSA (Cell Cycle Specific agents) according to their different effect on tumor cells in different stages of generation cycles. Both of them have a killing effect on bone marrow hematopoietic stem cells and other cells with a short growth cycle, as well as an inhibiting effect on the bodys immune response.
Factors such as growing incidence of cancer across the globe and demand for cost-effective treatment options are believed to play crucial role for the growth of global anti-neoplastic agents market. Rapid innovation in the field of personalized medicine presents a huge opportunity to manufacturers of anti-neoplastic agents. However, heterogeneous nature of cancer and high development cost of neoplastic agents are the factors limiting the growth of global anti-neoplastic agents market.
Access Report Details at: https://www.themarketreports.com/report/global-anti-neoplastic-agents-market-research-report
The global Anti-Neoplastic Agents 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 Anti-Neoplastic Agents volume and value at global level, regional level and company level. From a global perspective, this report represents overall Anti-Neoplastic Agents 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 Anti-Neoplastic Agents Market report are Hoffmann-La Roche, Amgen, Bristol-Myers Squibb Company, Baxter, Boehringer Ingelheim, Bayer, Teva Pharmaceutical Industries, Johnson & Johnson, Merck, Pfize, Accord Healthcare, Lundbeck, Abbvie and more in term of company basic information, Product Introduction, Application, Specification, Production, Revenue, Price and Gross Margin (2014-2019), etc.
Purchase this Premium Report at: https://www.themarketreports.com/report/buy-now/1416837
Table of Content
1 Anti-Neoplastic Agents Market Overview
2 Global Anti-Neoplastic Agents Market Competition by Manufacturers
3 Global Anti-Neoplastic Agents Production Market Share by Regions
4 Global Anti-Neoplastic Agents Consumption by Regions
5 Global Anti-Neoplastic Agents Production, Revenue, Price Trend by Type
6 Global Anti-Neoplastic Agents Market Analysis by Applications
7 Company Profiles and Key Figures in Anti-Neoplastic Agents Business
8 Anti-Neoplastic Agents Manufacturing Cost Analysis
9 Marketing Channel, Distributors and Customers
10 Market Dynamics
11 Global Anti-Neoplastic Agents Market Forecast
12 Research Findings and Conclusion
13 Methodology and Data Source
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Global Anti-Neoplastic Agents Market: Development History, Current Analysis and Estimated Forecast to 2025 - Market Research Reporting
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FXS Study Finds More-than-expected Carriers in Pregnant Taiwanese – Fragile X News Today
One in every 777 pregnant women in Taiwan carries a premutation in the FMR1 gene, which is associated with a greater likelihood of having a child with fragile X syndrome,a large study reports.
This is a higher-than-anticipated prevalence, although lower than Western populations, the scientists noted.
The research, Fragile X syndrome carrier screening in pregnant women in Chinese Han population, was published in the journal Scientific Reports.
Fragile X, the most frequent genetic cause of autism, is caused by the expansion of CGG repeats in the FMR1 gene, which provides instructions for making the fragile X mental retardation protein, or FMRP. Of note, C stands for cytosine and G for guanine, two of the four building blocks of DNA.
Full mutation carriers typically have more than 200 CGG repeats, while premutation carriers have between 55 and 200 of such repeats.
While premutation carriers can have normal FMR1 activity, their children are at a higher risk for acquiring the full mutation. In addition, premutation carriers can develop FMR1-related disorders in their adult life, including fragile X-associated tremor-ataxia syndrome.
The prevalence of fragile X in the Chinese population has been regarded as low, which puts into question the need to conduct screenings. Yet, recent studies in populations from Hong Kong and Korea indicate that approximately one out of 883 parents carry FMR1 gene mutations.
Researchers assessed the actual prevalence of premutation and full mutation carriers among 20,188 pregnant Taiwanese women of Han Chinese ethnicity who underwent genetic testing. Average age was 31.7 years, and age range was 20 to 54. Those who tested positive were referred for genetic counselling.
This is by far the largest study of the reproductive FXS carrier screening in Chinese women, the team wrote.
Results showed that 19,982 women (98.9%) had less than 45 CGG repeats and were considered normal. Nearly 40% of women (39.3%) carried 29 CGG repeats, followed by 25.6% with 30 repeats. Less than 10% had 28 (8.60%) and 36 repeats (6%).
A total of 26 women (0.13%, or one in 777) were carriers of FMR1 premutations. Twenty-one women underwent amniocentesis to assess genetic disorders of the fetus, while five women underwent genetic tests after delivery.
Premutations were passed from mother to fetus in 17 pregnancies, with six expanding to full mutations. All 11 fetuses carrying premutations were delivered, while four out of six pregnancies with full mutations were terminated.
One mother had an asymptomatic full mutation with 280 CGG repeats. She had a family history of intellectual disability and terminated a first pregnancy of a male fetus carrying a FMR1 gene deletion. Unlike females, males have only one X chromosome so a full mutation in the only FMR1 gene copy (allele) means that they will develop fragile X. After genetic counselling, the woman experienced a successful second pregnancy and gave birth to a girl.
A rarer genetic alteration was found in one woman, who had 29 CGG repeats in one allele and a DNA deletion with nine CGG repeats in the other FMR1 allele. She decided to terminate her pregnancy of a male fetus who would have inherited this deletion.
Researchers also conducted a cost analysis of this large genetic screening. A test to identify premutation and full mutation carriers cost around $118,885 US. The total cost of amniocentesis (about $100 US per procedure) and prenatal fragile X genetic testing to identify a fetus with a full mutation is approximately $410,091 US.
Our research results also show that FXS [fragile X] carriers are not at all rare in Chinese, but they are much more rare than in western countries, the researchers wrote.
The reported FXS carrier rate in Taiwan is important for prenatal counseling and for the implementation of universal screening as a public health policy, they added.
Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.
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Jos is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has also studied Biochemistry at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario in London, Ontario, Canada. His work has ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimers disease.
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Why Researchers Should Have Sex (and Gender) On the Brain – Technology Networks
Thinking about sex and gender would help scientists improve their research, a new article published today argues.
Writing in a special 150th anniversary edition of Nature, five experts say these factors are too often ignored.
They say incorporating sex (the biological attribute distinguishing females, males or intersex/hermaphrodite individuals) and gender (psychological, social and cultural factors affecting how an individual identifies in society) could improve experiments, reduce bias and create opportunities for discovery and innovation.
The article highlights a host of examples in which including sex and gender has led to advanced understanding or insight - from male and female shellfish responding differently to climate change, to gendered social robots and to computer vision improvements prompted by evidence that facial recognition systems misclassify the sex of darker-skinned women more often than lighter-skinned men.
"It's striking to what degree sex and gender are overlooked in science," said co-author Dr Robert Ellis, of the University of Exeter. "We need to include this at every level of research and in everything we do, or provide robust scientific justification as to why sex or gender are unimportant, based on experimental evidence.
"Things are certainly improving. For example, the original crash test dummies were based on a male physique, however a study found that as a result US female drivers were 47% more likely than males to suffer severe injuries in a comparable crash. Such insight undoubtedly helps engineers design more sophisticated test platforms that will ultimately prevent major injury or save lives.
"Sex and gender are increasingly seen as important in research, but misconceptions and under-consideration still persist. We know, for example, that researchers' sex can affect how they interpret their observations, so this should be considered during the research process."
The paper focusses on four key areas - marine science, biomedicine, robotics and artificial intelligence - but the authors say the lessons apply across scientific disciplines. They highlight scientific successes achieved due to consideration of sex and/or gender.
Dr Tannenbaum from the Canadian Institutes of Health Research points to our deeper understanding of the genetic basis for sex differences in immunity.
"We now know immune cells function differently depending on whether they have XX or XY chromosomal complement or are exposed to different concentrations of sex hormones in the body. There are exciting implications for antibody treatments and new cancer immunotherapies. Who knows? One day men and women may be treated completely differently for the same health condition. Patients should ask their healthcare provider if the treatment being recommended works equally well for individuals with their same sex and gender. "
A study in mice showed, surprisingly, that pain levels the animals exhibited changed depending on whether a male researcher was in the room. Researchers concluded that the animals responded to a scent associated with men. What's more, whilst both female and male animals showed this response, female mice were more sensitive.
Marine biologist Dr Ellis said: "Within the oceans there are many examples highlighting the importance of considering sex differences within species. In marine turtles, incubation temperature determines the sex of hatchlings, so climate change could poses a major threat to this group and could lead to the total feminisation of some turtle populations.
"Marine biology also reminds us of the need to challenge the assumption that sex is binary and fixed. Clownfish, for example, are 'protandrous hermaphrodites' (they mature as male; some change to female). Living in a strict social hierarchy each family contains a single dominant female that mates with a single large male in the social group.
"All remaining individuals remain juveniles. Removal of the alpha female results in the alpha male changing sex to female, with all subordinates moving up a rung in the social hierarchy. This natural phenomenon certainly adds a fascinating plot twist to the Finding Nemo story, but it also highlights a key area of biology that requires further study in relation to things like climate change."
The paper says the goal is to "increase transparency, promote inclusion and reset the research default to carefully consider sex and gender, where appropriate". For instance, one would hardly assume that social robots are attributed a male or female gender.
However, as social psychologist and social roboticist Dr Friederike Eyssel from Bielefeld University emphasizes: "People use mental shortcuts to evaluate nonhuman entities and through the process of anthropomorphising social robots, humans even ascribe gender to robots. Empirical and experimental research has shown that this impacts the perception of such novel technologies.
"Moreover, gendering robots has strong social and ethical implications that need to be taken into account by developers of social robots and by stakeholders who aim to deploy robots in various domains of use in people's everyday lives. At the same time, clearly, further research is called for to explore the effects of gendered technologies in field settings. The existing literature marks a relevant first step to our understanding of the role of sex and gender in the design and uptake of novel technologies."
The Nature "Perspective" sets out a "roadmap" and calls on researchers, funding agencies, journals and universities to coordinate efforts to implement robust methods of sex and gender analysis. It concludes: "Eyes have been opened, and by integrating sex and gender analysis into their work, researchers can enhance excellence and social responsibility in science and engineering."
Reference: Tannenbaum, C., Ellis, R. P., Eyssel, F., Zou, J., & Schiebinger, L. (2019). Sex and gender analysis improves science and engineering. Nature, 575(7781), 137146. https://doi.org/10.1038/s41586-019-1657-6
This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.
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Why Researchers Should Have Sex (and Gender) On the Brain - Technology Networks
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Listening Carefully: A Critique of Father James Martin’s Critique of Male and Female He Created Them – Patheos
In his response of the recent document of the Congregation for Catholic Education, Male and Female he Created Them: Towards a Path of Dialogue on the Question of Gender Theory in Education, Fr. James Martin asks the Congregation, and Catholics more generally, to Listen to the L.G.B.T. person. It is true that in the section on listening (the first of three sections in the document, the following two being reasoning and proposing), the Congregation is concerned not primarily with the experience of individuals, but with the theoretical frameworks being proposed and promulgated by which people interpret that experience.
While it is critical of these frameworks, it is in the Points of Agreement part of this section that some of the more quoted and quotable elements of the document appear. In particular, Martin and others do not fail to note the Congregations commending a laudable desire to combat all expressions of unjust discrimination and agreement on the need to educate children and young people to respect every person in their particularity and difference, so that no one should suffer bullying, violence, insults or unjust discrimination based on their specific characteristics.
While I agree with Father Martin that future work in this sensitive area unquestionably requires listening to the experiences of real concrete individuals created in the image and likeness of God, it is important to recognize that the kind of listening Father Martin is encouraging does not necessarily lead to the kinds of conclusions he seems to presume it will. Indeed, in my own work in this area, I have been privileged to learn from the stories of many people. I want to share two of those stories here (anonymously), not because they trump all other such experiences and can be used to deny the experience of others, but because they intersect with and complicate Father Martins critique of the document at two very specific points.
A young woman grows up not feeling particularly feminine and struggles with what this means for her identity. She is self-consciously not like other girls. As she grows up, she encounters the possibility that some women who are different from other women are lesbians and discerns that this describes her as well. Presently she enters into a romantic and sexual relationship with another woman. At a certain stage in her journey, medical tests indicate abnormally high levels of testosterone and correspondingly low levels of female sex hormones.
Time passes. The notion of being transgender, often colloquially described as being a man trapped in a womans body (or vice versa) becomes more culturally widespread. This new, to her at least, understanding actually seems to describe her situation in a much more satisfactory way than her earlier attempts at self-understanding through identification as a lesbian. Her hormones actually are out of balance! The inside of her body actually is masculine! The truth of her identity is now clear: she is not, in fact, a woman at all. She is really a man. Accordingly, she begins hormone therapy, not to correct the imbalance in her system, but to exaggerate it. She takes more male hormone and undergoes top surgery (the removal of her breast tissue) in her effort to live the truth of her masculine identity.
In his critique, Father Martin argues that Male and Female He Created Them relies mainly on the belief that gender is determined solely by ones visible genitalia, which contemporary science has shown is an incorrect (and sometimes even harmful) way to categorize people. Gender is also biologically determined by genetics, hormones and brain chemistry things that are not visible at birth.
That this is a remarkable claim about the document becomes apparent when read next to the following quote from paragraph 24 of the document itself: the data of biological and medical science shows that sexual dimorphism (that is, the sexual difference between men and women) can be demonstrated scientifically by such fields as genetics, endocrinology and neurology. The document is not only aware of other biological factors related to the biological determination of gender; it lists them in the same order as Father Martin. Nowhere does the document mention external genitalia.
The most generous interpretation I can find for Father Martins claim is that, in his basic approach to the question, any critique of a transgender framework for interpreting human experience is necessarily and by definition tied to a belief that gender is determined solely by ones visible genitalia. And so he can read the document as relying mainly on a belief that is nowhere indicated in the text itself and is, in fact, contradicted by it.
But the problem is worse than that. When Father Martin appeals to genetics, hormones and brain chemistry, he is grasping a sword that cuts both ways for he is still in the realm of biological determination. For its part, in its indicators for a transgender diagnosis, the Diagnostic and Statistical Manual 5 makes no mention whatsoever of biological factors. The various criteria are all purely subjective and appeal above all to an interior felt sense.
As indeed they must, for the very definition of a transgender identification is that it is an identification that transcends ones body. It says that, no matter what you can discern about my body with your scientific implements, I know my own inner experience, and that alone is the determining factor. An appeal to genetics, hormones and brain chemistry means, very simply, that we can medically test for a transgender condition. One wonders what Father Martin would make of the results.
With this reference to genetics, hormones and brain chemistry, Father Martin is not, in fact, discussing the transgender situation at all. He is talking about a variety of intersex conditions. Such conditions are often invoked to explain or understand transgender phenomena. (At one point, the document itself even unfortunately seems to equate the terms intersex and transgender as efforts to go beyond the constitutive male-female sexual difference.) But, despite some superficial similarities (the superficiality of which is clearly recognized by actual intersex persons!), a transgender identity is in an important sense the very opposite of an intersex condition. For in the first instance the internal sense is at odds with a completely unambiguous male or female body, while in the second instance the central question is the ambiguity of the body itself.
But this relatively straightforward and commonsense medical solution was ignored because a certain (and in many circles unquestionable) interpretive framework was used to make sense of one persons experience. A person with a (relatively minor) intersex condition was (mis)diagnosed as transgender and a relatively simple medical intervention was overlooked in favour of a dramatic and invasive (not to mention expensive and largely irreversible) series of interventions that do nothing to address the root of the problem.
A woman brings her son over to his friends house for a sleepover and is met in the driveway by the friends mother who informs the woman that the friend with whom her son is planning to spend the night is now a girl, and will be going by a new name henceforward. Moreover, the woman is told, this is very exciting because the mother has always wanted a girl. In fact, over the last little while, she has greatly enjoyed purchasing a brand new all-girl wardrobe for her new daughter and redecorating the childs bedroom. Several months later the woman sees that the young man has returned to using his birth name on social media, but seems to have had some significant alterations to his secondary sex characteristics that are difficult to disguise.
Father Martin is concerned that [t]he congregation also suggests that discussions about gender identity involve an intentional choice of gender by an individual. But people who are transgender report that they do not choose their identity but discover it through their experiences as human beings in a social world. The most relevant quote from the document here (found in paragraph 11) is the concept of gender is seen as dependent upon the subjective mindset of each person, who can choose a gender not corresponding to his or her biological sex, and therefore with the way others see that person (transgenderism).
On the one hand, it is hard to see how the congregation did not see this critique coming. Any suggestion that people are arbitrarily choosing their gender was certain to be met with incredulity. The Catechism, at least, is more sensitive on the issue of choice when it comes to homosexuality (stating simply that [i]ts psychological genesis remains largely unexplained 2357). On the other hand, as both the stories we have looked at illustrate, the relationship between experience, choice, and identity is a lot more complicated than Father Martins discover it through their experiences as human beings in a social world would seem to indicate.
We do not exist in a cultural vacuum. We are only able to discover identities that our social world makes available to us. Even if, per impossibile, our experience of self was completely unconditioned by the categories of our culture, our interpretation of those experiences is not. And while we do not choose how we experience any number of phenomena, it is possible, given enough critical distance, to choose how we interpret that experience. Indeed, some critical distance from the cultures regnant categories may well have introduced enough freedom into our two stories to have saved the protagonists from significant suffering.
One common response to stories like those shared here is that they are not stories of real trans people and so cannot be used to understand the experience, let alone critique the self-understanding, of real trans people. But does this not simply beg the question?
Indeed, whether one believes as Father Martin does, that such real trans people exist, or whether one believes, as the Congregation seems to, that such identities are never, in the final analysis, a helpful way of categorizing human experience, everyone implicitly agrees that at least some people who claim to be trans at one point or another simply are not. Furthermore, given the growing prominence of the category transgender in the culture, it would seem probable that the number (and proportion, unless the Congregation is correct and the proportion was already 100%) of such people is increasing, even dramatically so.
I would like to suggest that the Congregation would have been less likely to be misunderstood on the question of choice if it had adverted to a distinction between a given experience (gender dysphoria) and a given framing of that experience (I am transgender or I am a man in a womans body). It is clear that people do not choose the experience of gender dysphoria. On the other hand, there is a way in which we do choose to interpret our experiences given the frameworks available to us, even if we are not always conscious of doing so. To say I am a man in a womans body is one way of interpreting ones experience. It sounds to many like a simple contradiction and therefore a meaningless statement. To others, however, it has become a way to make sense of their reality (or that of others) with language that is increasingly socially acceptable and accessible.
An irony emerges here. As the category transgender becomes more and more common and acceptable, even lionized, the choice to employ it as an interpretive lens for understanding ones own experience becomes less and less obvious until it is not recognized as a choice at all. That is to say, it is not that a given experience or set of experiences demands a certain interpretive framework. It is rather that a given socially constructed framework has become so second nature (I use the term advisedly) that it is no longer perceived as a social construct.
And this lack of perception is most common among the same people who most clearly see ways in which gender itself is a social construct. And so we end up speaking as if an experience of gender dysphoria is a more or less straightforward discovery of an immutable and innate transgender identity. But, as our two stories (and they could be multiplied) show, the experiences of concrete people are much more complex than that.
Lets listen to them.
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Listening Carefully: A Critique of Father James Martin's Critique of Male and Female He Created Them - Patheos
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National Hereford Calf Show set for this Sunday – Agriland
The sixth National Hereford Calf Show will take place this Sunday, November 10, which will feature over 90 entries across a number of events and competitions.
The show will kick off at 10:00am at GVM Tullamore, Tullamore, Co. Offaly. The day will start with two young handlers classes.
The winners of the junior and senior handlers competitions will each receive a new dazzling belt buckle, which have been sponsored by farm clothing supplier Farm Wardrobe.
There are five female classes and five male classes. There is also a commercial Hereford sired calf class, which the organisers say is aimed at promoting the commercial viability of the Hereford breed. This competition is offering superb prize money, according to organisers.
This years event was launched at the 2019 National Ploughing Championships in September by the Irish Hereford Breed Society (IHBS) and the North Leinster Hereford Branch, who established the first calf show in 2014.
The calf show has gone from strength to strength each year, attracting exhibitors from all over the country, as well as spectators from the UK, and as far away as Denmark, the organisers said.
As part of the preparations for the World Hereford Conference in New Zealand in March 2020, the winners of the IHBSs travel bursary for that event will be on hand on Sunday to assist breeders with washing, drying, clipping, grooming and leading calves.
The judge for this years event will be Non Thorne, from the Studdolph Poll / Glenvale Poll and Ashdale British Polled herds in Pembrokeshire, Wales, whose family have been breeding Herefords since 1946.
The organisers said: She is no stranger to the show ring, having won numerous accolades over the years, including herd of the year. In July 2019, Non had the honour of judging the Hereford classes at the Finnish National Show, and we look forward to welcoming the Thornes to Tullamore on Sunday.
Among the sponsors for this years show are: Farm Wardrobe; ABP; Animax; Dovea Genetics; Greenvale Animal Feeds; GVM Marts; Hereford Prime; Hugh Mulvihill Auctioneer; Lakeland Dairies; Progressive Genetics; and Slaney Meats.
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National Hereford Calf Show set for this Sunday - Agriland
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The Real-Life Diet of Tommy Chong, Who Knows the Secret to Beating the Munchies – Yahoo Lifestyle
A man who dances the tango rules the world, says Tommy Chong, the reefer king of Cheech & Chong fame. Hes not speaking about his younger yearsChong is still doing the tango now, at 81, after first showing off his abilities in season 19 of Dancing with the Stars. He attributes his long-enduring physical fitness to genetics, among other factors; while chatting with me on the phone from a casino, he sounds as sharp as ever, his voice warm and rumbly.
When hes not lighting up the slot machines or dancing the night away, Chong sticks to his bread-and-butter: stand-up and sketch comedy, and advocacy for the legalization of marijuana. Weed, he says, has played a central role in his relatively good health over the years, and helped him cope when he was diagnosed with colorectal cancer in 2016. (He is now in remission, and feeling great.)
During our conversation, Chong expounds on the health benefits of marijuana, his all-time favorite ways to exercise, and he also unveils what is, by far, the worlds most ingenious solution for beating the munchies.
GQ: If youll allow it, I was truly taken aback to learn youre 81you look great! Do you maintain a wellness or fitness regiment?
Tommy Chong: Well, when I was a kid, I played football, which is what got me interested in exercise. Its where I learned about calisthenics, and running, and lifting weights. Its a combination of weightlifting and spiritual wellness for me.
When did you start lifting weights?
Ive been lifting weights since I was 15 years old, but trust me, I was not a natural at it. I ended up moving out to Hollywood to do a movie, and I signed up with a trainer. It was this guy named Vince Gironda, and he had a special at his gym: 25 bucks and well get you in shape for a movie. He got me in the best shape of my life for Up in Smoke. He gave me a big lecture on how to maintain a diet and such. Ive just been following that routine to this day. Oh, and I invented a knee machine for myself.
A knee machine?
Yeah, I grew up poor so everything that cost moneysports like golf, or skiing, or whateverI didnt try out until later in life. When I started skiing, I realized I couldnt ski on moguls because it takes a lot of balance and its a big stress on your knees. So I invented this knee machine, I call it the bouncer. Its a skateboard stretched between four springs on a frame, and I just bounce on it like Im going over moguls. I should really put it on the market once I get it all togetherafter all, Ive only been working on it for 30 years now! It helps me with my circulation, and thats a huge part of keeping yourself healthy. I use that, and do a lot of walking, and have my tai chi, which is tango.
Tango? Like, the dance?
Yeah, Im a tango dancer. Ive been studying tango for years now. I love it. Ive tried to tell everybody about it, but people wont listen to me. Ive walked into classes and just had a blast dancing with people. With tango, the male dancer has to know what hes doing, because hes the lead. When I was on Dancing with the Stars, the pros they partner you with will back-lead the dance. So Ive been trying to get rid of that habit and learn how to lead the dance for the last couple of years. Thats why Im still taking lessons and classes, because you never stop learning to dance. My wifewho is gorgeouslikes to dance tango as well. Its fun, and it keeps things exciting. My other bit of advice for old guys is to check out the new fashion magazines, and do what they say.
Dance is such a wonderful exercise, and I dont think people always realize that.
Its great! Its the best. I get to get all dressed up, and I get to dance with my beautiful wife. My only problem is that sometimes my wife looks so good that I just want to give her a big hug instead of dancing.
When you were touring the country, what did your diet look like? Did you try to stop in at as many different restaurants as you could?
Well back in the day, me and Cheech always used to go and eat at places in Chinatown [in Vancouver], since they tended to have the cheapest and most nutritious dishes we could find. I had to teach Cheech about all of the best Chinese food dishes so we could order what was actually good, and he taught me about all the best Mexican dishes.
Youre a big advocate for the legalization of marijuana in the United States. What, in your estimation, are some of the health benefits of weed?
For one, its a great natural relaxer and painkiller. Back in the day, when I was lifting at Golds Gym, I met this big Austrian bodybuilder named Arnold Schwarzenegger. He barely spoke any English, and he was so health-conscious about his diet and his exercise. The only thing he would do for entertainment besides exercise was smoke a joint. Kareem Abdul-Jabbar also used it for years to treat his migraines. See, what pot does so well is it helps out your brain. Every aspect of your body will benefit from the relief that pot can give you. The only problem with pot is the munchies. The way you get around that though is to have something healthy in the refrigerator to eat when youre stoned.
Do you have a go-to healthy munchie?
Celery. I actually hate celery, but it gives you the crunch factor. The whole thing you want from any munchie is crunchiness. When youre stoned, youre just looking for that satisfying feeling. The whole sensation starts in your mouth, and then it satisfies your brain, and thats why people love potato chips, candy, all that stuff when theyre high. With celery, youre in good shape, because realistically, you can only eat so much celery.
This interview has been edited and condensed for clarity.
Real-Life Diet is a series in which GQ talks to athletes, celebrities, and everyone in-between about their diets and exercise routines: what's worked, what hasn't, and where they're still improving. Keep in mind, what works for them might not necessarily be healthy for you.
Referee, Phenizee Ransom, October 13, 2019.
The Real-Life Diet of an Up-and-Coming NBA Referee
Phenizee Ransom compares his job to a marathon runners.
Originally Appeared on GQ
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Well-bred, well-trained stock dogs can play a vital role in livestock operations – Farm Talk
When Ability Stock Dogs breeder and trainer Linda Holloway brings a puppy into the world on her Ponca City, Oklahoma, farm, she is instantly assessing potential. The first seven weeks of the dogs life will be a series of significant but subtle aptitude tests to determine the job and lifestyle the puppy needs.
I want the dogs that are always capable of figuring a way over obstacles and are always looking for something, Holloway said. I try to match their mentality to the people theyre working with.
Beginning by training a few Smooth Collies in the early 1980s to herd her sheep and compete in trials, Holloway has been a stock dog breeder and trainer for over 40 years. Today, Holloway breeds herding intensive Smooth Collies and Border Collies, as well as training and judging competitive stock dogs.
In 2014 Holloway was named the American Kennel Clubs Herding Breeder of the Year, but by far most of the dogs she trains will spend their lives accompanying cowboys and livestock producers.
Most of my dogs are bought for regular old farm work, Holloway said. I do sell some dogs to trial homes and in the Smooth Collies I have some that will go to competitive agility or herding homes, as well.
Holloways skills as a trainer show early on in her attention to detail with her dogs almost from the moment they are born.
At 5 weeks the puppies will follow you so I begin walking through the pasture and through the woods over deadfall, Holloway said. On these walks, youre trying to put them in situations to figure out who cries, who wont go and who goes first.
This early observation period is important because Holloway wants to ensure she has a good idea of each individual dogs personality and has a person in mind to match before the dog reaches 7 weeks of age.
Seven weeks is the time, I think 49 days exactly, is when they psychologically unbond from puppies and will bond to a person, Holloway said, so 7 weeks is the time you want to pick the dog up.
After 7 weeks the dogs get their own personalities, and while its less likely to cause training issues in Border Collies later the way it does for other dogs, Holloway said theres something unidentifiable that gets lost in translation if the puppy and partner dont have a chance to bond early.
Other behavioral traits are more hard-wired into the dogs actual DNA. Useful traits like herding or even behavioral traits are traceable to a dogs lineage.
I dont want nuisance barking or dogs that run back and forth constantly, and all of those things have genetic foundations, Holloway said. Ive bred all of that out to focus on dogs that behave and also dont fall apart under correction.
For Holloway, a corrective and cognizant trainer or owner is almost as important to the foundation of a great stock dog as genetics.
Dogs spend 24/7 watching us, but how many hours a day do we really spend watching a dog? Holloway said. Those habits establish early and when you arent paying attention.
Choose Wisely
The first step in any relationship is choosing a partner that matches the problem. Knowing what youre looking for out of a dog-owner relationship is key to picking out the right kind of stock dog.
For Holloway, the first and most important trait to consider is genetic herding ability, especially in dog breeds like Smooth Collies, Shelties or Australian Shepherds where the number of working bloodlines have become diluted over time.
Dont believe the parents work until you see them work for yourself, Holloway said. If one of the parents doesnt work, then dont buy them because herding is such a hard trait to maintain.
Even within herding genetics, Holloway said its important to know what kind herding the parents have been doing. While she trains her dogs first on ducks, then goats, sheep and eventually cattle, the cow-bred lines in her Border Collies always lead to a different working environment than her sheep-bred Smooth Collies.
Cow lines run tighter than the sheep dog lines, Holloway said. The cow lines will stay in that pressure zone unlike sheep bred dogs, so the genetics make some difference.
Holloway said its important to let your breeder or trainer know what tasks the dog will be expected to perform while working. Dogs that do well rounding up cattle in the pasture or working alongside horses might not be suited to light working conditions.
Similarly, stock dogs that are used primarily for blocking gates or guarding the truck while feeding might not perform as well at herding.
Once you teach them to antagonize livestock, theyre going to make mistakes and they arent going to listen because you just gave them a green light, Holloway said. It takes a lot of mileage to get a dog that can both guard the cake feeder from the bed of the truck and also round up cows effectively.
Once shes aware of the owners needs, Holloway said she rarely sees a bad dog-owner pairing as long as both temperaments match up well.
People need to be honest about what they want and need in a dog and then take care of it, Holloway said.
Keep Your Cool
When training, correcting or working alongside stock dogs and livestock its easy for physical and emotional overload to play a role.
People allow themselves to get rattled and things dont go well and then they shut down, Holloway said. Sometimes you need to take a break, have a cup of coffee, let everything settle and then go back to it.
Livestock and dogs both feed off of emotions in their environment. While most livestock owners can sense this mood shift instinctively, it might not be intuitive to watch the dogs behavior shift as well.
People read livestock really well especially these guys that handle cattle for a living, but sometimes they can really underestimate what the dog is feeling, Holloway said.
When making corrections, Holloway said it is important to be firm but to also allow the dog to bounce back from the correction. Ensuring the dog knows the reason for the correction and has the opportunity to perform it correctly can help eliminate correcting the same fault over and over again.
Everybody makes mistakes, Holloway said. I make mistakes, the dog does, the cows do, and everyone just needs to settle down."
Speak Clearly
Whether utilizing classic commands like go by and away or using simplified commands like stop and lay down, everyone that will be commanding the dog needs to be in sync on the language of the commands.
The syntax has to be the same, Holloway said, so if your syntax is Buffy fetch, then everyone needs to use that syntax and you cant say fetch Buffy.
When the dog is being trained around a family or multiple handlers, it can be confusing for the dog to understand individual nuances in voice or tone, Holloway said. After the dog gets used to its work pattern and living situation, it can determine who to obey and when more effectively.
Training, like so many other stock dog behaviors, can be influenced through genetics and years of training practices.
It used to be that when you did obedience training the dog would work because you said good dog, Holloway said. They have bred that ability to be satisfied with just words is all going away, as is the ability to get corrected and recover because of positive training.
Develop a Pattern
For herding dogs, a specific and consistent job is required. Dogs that have been bred intensively will look for jobs to fulfill and they will attempt to do the same job, the same way over and over again once they have been instructed.
Holloway said it is important to develop a working pattern for stock dogs and to keep that pattern regular until the dog gets older and can determine pattern shifts easier over time.
You need to get them conditioned to the task and be able to call them off, Holloway said. Herding dogs find patterns really quickly.
Dogs with problem solving and judgment will eventually tune in to the daily or seasonal shifts in jobs, but judgment comes with age and Holloway said it could be three to five years before a stock dog is quickly adaptable.
They start and look OK but the judgment isnt there, Holloway said. I think its easy to put them over their head because they have a good day.
Manage and Evaluate Expectations
When an owner purchases a well-trained stock dog, it is easy for high expectations to come with their investment but its important to evaluate and manage those expectations for dog-owner relationship longevity.
If you put them in situations where they arent challenged, they either get bored and destroy things or they will lose their edge, Holloway said. Herding dogs are smart, theyre visual, and they arent going to stay on the porch.
Similarly, when a dog is performing well its important to make sure not to overestimate their skill or maturity and put them in situations where failure is imminent.
They can read a bad situation based on the temperature of the livestock, Holloway said. They may come in with not enough force or not enough confidence because they know their situation is tenuous.
When those situational failures happen, Holloway said it is important to let the dog know it has backup. Leaving the dog to fend for itself and possibly be injured is a recipe for disaster and doesnt build trust between dog and owner.
Its just a 45-pound dog, Holloway said. Its not a miracle worker.
Continued here:
Well-bred, well-trained stock dogs can play a vital role in livestock operations - Farm Talk
Recommendation and review posted by Bethany Smith
How BYU’s Blake Freeland went from high school QB to starting right tackle in one semester – KSL.com
PROVO Blake Freeland has been in plenty of nerve-wracking situations throughout his athletic life, but none quite measured up to last weeks 42-14 win over Utah State.
Loud. Motivating. Humbling.
There were a lot of emotions surrounding the 6-foot-8 Herriman product as he prepared for his first career start at right tackle in the Wagon Wheel rivalry.
He was intense. He was antsy.
I was just ready to get off the ball and ready to hit somebody, he said. I was excited.
That excitement got the better of him early, with a couple of penalties. But then something happened to Freeland.
He settled down. He played his game. And he helped pave the way to 42 points, to 639 yards of offense both season-highs for the Cougars and a rout of their in-state rival.
I thought he settled in and did a really nice job, BYU offensive coordinator Jeff Grimes said. It was an improvement over his first week and again, hes not just new to our lineup. Hes new to playing offensive tackle. This is all new for him. Hes still learning at a high rate.
Last Saturday wasnt the first time Freeland has had a lot of pressure placed on him, even at just 18 years old. A two-year starting quarterback at Herriman High, Freeland played his senior season rotating between tight end, fullback, defensive tackle and defensive end. It was all to get him ready for his college career, when he settled on the offensive line, he said.
Freeland helped the Mustangs to the Class 5A state championship in 2015. But football wasnt the only time he felt pressure, either.
An all-everything thrower at Herriman High, Freeland captured the throwers trifecta at the Utah state meet last year, garnering titles in the shot put, discus and javelin. He wouldve won another title in the hammer throw, too, if the Utah High School Activities Association sponsored the event, BYU head coach Kalani Sitake argued.
Hes a fighter, and he works hard, Sitake said of his new starting right tackle. Hes not new to success and competition; hes explosive.
So how did a former starting quarterback make the transition to 6-foot-8, 285-pound offensive lineman with room to grow? Injuries played a role, as did the host of other backups fulfilling their own responsibilities on the field. But Freeland and fellow freshman Harris LaChance, who are listed as co-starters at right tackle, have slid into a high-demand role seamlessly and seemingly effortlessly to help BYU to back-to-back wins over a pair of regional rivals.
As with a lot of questions, the answer lies in several solutions: by a combination of genetics, athletic ability, preparation, and the same hard work Sitake and Grimes have noticed every week.
***
Blake Freeland isnt the only athlete in his family. Truth be told, he might not even be the most athletic.
Freelands father James played at BYU from 1994-95. A native of Arlington, Texas, Jim Freeland earned letters in football, basketball, track and field and baseball at Amador Valley High in Pleasanton, California, and was the Northern California Athlete of the Year before going on to star at linebacker at Ricks College. Recruited by UCLA, Iowa, Alabama, Florida, Tennessee, Boston College, Oklahoma and Texas, he settled on BYU and wrapped up a two-year career with 16 tackles, including 11 solo stops and a fumble recovery.
While there, he met and married Blakes mother Debbie. A two-sport athlete at BYU who also played volleyball, Debbie Freeland was an honorable mention All-American with the womens basketball team from 1991-95. And while Blake Freeland is the only boy in his family, one of his four sisters Sierra is on the BYU track and field team, as well.
So its impossible to ignore the role of genetics in the younger Freelands steady acclimation to Division I football. He hasnt even filled out his frame yet, either; hes added nearly 20 pounds since his senior year of high school, and coaches estimate he can put another 40-50 pounds on his 285-pound frame, as well.
He has all the tangibles to be a Division I tackle.
Hes just a tough guy. Hes a quick learner, and intelligent, BYU offensive line coach Eric Mateos said. Hes got football intelligence from playing different positions. And hes got grit. When youve got those things, you have a chance to be OK.
Hes graded out OK not what were looking for in our room but hes improving. Thats a good thing.
And yet, that only tells part of his story.
Watching his growth, even before his number was called, was the way he always worked his hind end off, BYU teammate Chandon Herring said. He just goes and goes and goes. He has a great football IQ, hes a great dude, and hes the epitome of what you want as an O-lineman at BYU.
***
BYU offensive coordinator Jeff Grimes had a story this week after wrapping up another day of practice before Saturdays home tilt against Liberty (5:30 p.m. MST, ESPNU).
It came from last week, when the second-year offensive coordinator was preparing his guys for a road game at Utah State. He knew it was going to be the first start of Freelands freshman season, and whether the youngster admitted it or not he probably felt a little nervous.
So Grimes was surprised when he walked out of his office, long after practice, after showering, and after doing his own coaching work. He heard voices coming from the offensive line team room.
It was nearly 8 o'clock at night. Who would still be in the BYU practice facility?
He turned the corner, and saw two of his pupils Freeland, and Chandon Herring, the redshirt junior right guard who had taken the freshman under his wing all year watching film and reviewing team concepts after a long day.
I think its a real credit to James (Empey), Brady (Christensen) and Chandon, for taking those young guys under the wing, Grimes said, and helping them get caught up.
Its not just the linemen, though. Herring said the Cougars, both players and coaches, have preached a culture of accountability, with guys regularly meeting outside of practice time to throw, to run extra drills, or to study film on next weeks opponent. That culture increased two weeks ago, following surprise losses to Toledo and South Florida, and has proven dividends with wins against regional rivals Boise State and Utah State.
I think thats a team thing, across the board, Herring said. Everyone on our team likes to put in as much extra work as they can fit into their schedule.
That support from coaches and teammates helped Freeland when he was thrown into the starting spotlight.
It was a learning curve, for sure, he admits. But being surrounded by all the guys coach Mateos, coach Grimes, my O-linemen theyve all helped a ton with my growth, both mentally and physically. Im always trying to get extra work in, and theyve helped a ton.
***
Freelands background in football isnt the only impressive thing about him.
The 2019 Gatorade Utah boys track and field athlete of the year, Freeland won the throwers hat trick of state titles in the shot put, discus and javelin. He also moonlighted as the starting center on the Mustangs boys basketball team, a two-time team captain that paced Herriman to the Class 6A state quarterfinals last February.
Freeland even played in the same AAU program as current BYU star Yoeli Childs though that mostly amounted to watching the Bingham High product decide to dunk on everybody, he jokes.
Basketball was never his primary sport no, BYU coach Mark Pope has not called to inquire for his services this winter. But an All-American mother and that same work ethic helped Freeland learn the footwork that would later enhance his offensive line technique.
Coach Grimes and coach Mateos will always teach me some things, and then theyll say, Just treat it like a dunk and get up, he said. If I just explode through the guy, that helps.
Freeland pulls in elements from each of his previous stops at quarterback, at tight end, in track and field, and from the basketball court to assimilate into his right tackle technique.
Remember, hes still in his first year at that position.
But all those things can combine to make him a Division I lineman. And hes only getting started. In many ways, his new climb to the position is an asset.
His technique from his first game to his second game was much, much better, Mateos said. But when you havent played the position a long time, you dont have bad habits. Thats the good thing about him he doesnt have old habits that we need to break. Hes a piece of clay, and we get to do what we want with him.
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How genetic tests are tearing families apart and bringing others together – Noted
The flipside of a rogue DNA test, of course, is it can also deliver the devastating news to a father that he has no blood ties to his children. In the US and the UK, thats led to a wave of paternity fraud cases, where men have sued for damages after being hoodwinked into raising or financially supporting someone elses child. In 2017, a Liverpool woman was sent to jail for 12 months after admitting she faked a paternity test.
Auckland legal researcher Zo Lawton, who has investigated issues around deceitful and misattributed paternity, says men able to prove theyre not the biological father can apply to the IRD for a refund of child support. However no figures are kept on how often that has happened. In the UK and Australia, men have brought claims under the tort of deceit for emotional distress and the cost of raising the child. Lawton would be interested to see a test case argued here to see whether we follow the UK, where claims have been allowed, or Australia, which has been far more conservative. In New Zealand, there is no legal obligation for anyone to submit to a paternity test, and a court cannot order a child to be tested, although a finding can be made based on other evidence, as happened in the case of former Auckland mayor John Banks.
Lawton is writing a book on famous or landmark cases to do with sex, IVF and contraception. One involves a New Zealand man who claimed he was tricked into fathering a child and wanted out of child support obligations (the courts decision went against him). In another case, in Canada, a man was found guilty of sexual assault after he swapped his partners birth control for a placebo.
Sometimes the truth comes out when a relationship breaks down and the mother tells her partner hes not the biological father because she wants full custody, she says. Some men feel really angry and dont want anything to do with the mother or child. Others dont care theres no biological relationship and say, I love this child and I want to stay in their life. Its so complex.
Sometimes a non-biological father knows the truth from the outset, thinking theyre doing the right thing for the benefit of the child to minimise the hurt. But people arent good at keeping secrets. Eventually someone spills the beans.
Lawton says sometimes the secret is weighing on their mind, and they feel an obligation to let their son or daughter know. Others find out when their biological father dies. He feels guilty for not being in their life, leaves a note saying, Surprise! and a slice of his estate, which comes as a shock to the rest of the family.
Sometimes the child gets an inkling as they get older, especially a teenager who feels disconnected from their father or that theyre the oddball in the family, and starts digging around. DNA is just another way for them to find out.
Key players such as AncestryDNA and 23andMe have dedicated staff to handle more sensitive queries, yet the reality is their customers are often home alone when they click on their test results. Rebekah Drumsta thinks there should be compulsory warnings on DNA test kits about the potential harm of unexpected results, in the same way there are cancer warnings on cigarette packs.
AncestryDNAs international spokesperson Brad Argent, who gave a public talk in Auckland in June, recommends anyone considering an ancestry test should talk with their parents first, to give them an opportunity to disclose any family secrets. In his experience, most people whose results show an anomaly already had suspicions something was up. We do our best to inform people of the risks.
Also problematic is that DNA matching means even people not on the database risk automatically losing their genetic anonymity an issue raised in a recent blog by the Privacy Commissioner.
Last year, the commissioner was contacted by a man whose sister took an ancestry test, and discovered a close relative no one in the family knew about. The person turned out to have been conceived using sperm the man had donated in the 1980s, after being reassured he would be anonymous and untraceable. He complained that the DNA-testing company had not sought his consent in disclosing the existence of this person to his sister. However, in this case the Privacy Act (which regulates how agencies collect, use, disclose and store personal information) did not apply, because it was not the actions of the company but of the mans sister and his biological child that resulted in the information being revealed, because they had uploaded their DNA.
Dr Andelka Phillips, a senior law lecturer at Waikato University and a research associate at Oxford University, has privacy concerns around DNA testing, including the capacity of a legal guardian to give consent on a childs behalf, particularly because you dont know necessarily how long the data is going to be stored or who its going to be shared with.
Phillips also recommends discussing testing with your family, not just in case there are secrets, but because so much of our DNA is shared. Ancestry results, she notes, should be treated with caution. The tests are not standardised, so you can get contradictory results from different companies. Even the largest databases dont have large samples from all populations, and indigenous peoples and other minorities are often under-represented.
In most cases, she says, companies arent making a profit from the sale of the test kits themselves but by accumulating large databases that can be used in commercial partnerships. AncestryDNA recently teamed up with Spotify to create curated playlists inspired by a persons ancestral origins, while 23andMe is collaborating with Airbnb to provide genetically tailored travel experiences. The latter has partnered with at least 15 pharmaceutical companies; last year GlaxoSmithKline announced it was investing $US300 million into 23andMe to use aggregate customer data for drug research.
Read the fine print before ordering a genetic test online, advises Phillips. Her book Buying your Self on the Internet: Wrap Contracts and Personal Genomics has just been published by Edinburgh University Press. It looks at the rise of the genetic-testing industry, and the legal and ethical issues involved. Shed like to see specific regulation of the industry and far more transparency in DNA-testing contracts and privacy policies, particularly over consent for data to be used for research or shared with third parties, such as drug companies and law-enforcement agencies.
First rule of data: once you hand it over, you lose control of it, University of California law professor Elizabeth Joh warned recently on Twitter. You have no idea how the terms of service will change for your recreational DNA.
Read more: How the use of DNA in criminal investigations could violate your human rights
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How genetic tests are tearing families apart and bringing others together - Noted
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The Global Hair Restoration Services Market size is expected to reach $11.9 billion by 2025, rising at a market growth of 5.4% CAGR during the…
New York, Nov. 06, 2019 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Hair Restoration Services Market (2019-2025)" - https://www.reportlinker.com/p05826085/?utm_source=GNW Hair loss and baldness are common in males, primarily due to genetic factors and age.
The increasing rate of patients suffering from alopecia is a major factor that is boosting the demand for hair restoration service market. As stated by the International Society of Hair Restoration Surgery, over one million hair transplant surgeries have been performed in 2014, across the globe. The study also stated that among the total surgeries performed, 89% were conducted on the scalp area and 11% were targeted in the non-scalp areas. Furthermore, 87.3% of surgical patients were males, whereas 13.4% of patients were females.
The major market players competing in the hair restoration services market are Direct Hair Implantation International, Bosley Inc., iGrow Laser, Elite Hair Restoration, NeoGraft, National Hair Centers, Lexington Intl., Bernstein Medical, LLC, and Cole Hair Transplant Group. The market players are adopting progressive strategies to leverage the opportunities of the market. Companies are focusing on innovative strategies to compete in the market space.
For example, Dr. U Devices Inc. came into a partnership with Mamba Instruments S. A. In November 2018, Dr. U Devices Inc. the developer of Dr. UGraft Revolution Hair Transplant System came into a partnership and license agreement with South Americas popular hair transplant surgeon who is also the founder of Mamba Instruments S.A. HairMax introduced ACCELER8 Hair Booster + Nutrients in December 2018. It is a bioactive treatment to protect patients from hair loss.
Restoration Robotics, Inc., announced its approval of CE Mark for selling the ARTAS iX System with implantation functionality in Europe. The CE Mark approval follows the companys receipt in January 2019 of ISO 13485:2016 ARTAS iX Certification. With this consent, ARTAS users in Europe will be able to leverage the companys new platform that includes new implantation functionality, optimizes clinical outcomes, and further enhances the workflow of hair recovery processes. Through the global marketing team and distributor associates, the company will proceed to buy in these geographies as we retain our concentrate on extending our global business existence.
In July 2018, DHI launched DPR 360 program with Medical School of the University of Athens focusing on scientific approach in the diagnosis of hair loss. Glenmark launched hair loss treatment product in Russia. Glenmark Impex LLC, a subsidiary of the business, will solely market the item designed for male and female patients in Russia under a licensing agreement with Denmarks Pharma Medico ApS.
ZAOL Doctors Order is now accessible for the first time in the U.S. as a pioneering, clinically verified skin and scalp treatment with an advanced new method of application. Famous for its development in South Korea and supported by the leading company in the German biopharmaceutical sector, Dr. Niedermaier, ZAOL Doctors Order operates on transforming skin from the inside out, handling the scalp with specific nutrients to regenerate hair follicles, optimizing good skin development.
RepliCel Life Sciences Inc., a business that manufactures aesthetics and orthopedics methods of the next generation, is pleased to announce that their First-in-Japan strategy will be resumed. Working with sector officials, CJ PARTNERS, the company has launched a program in Japan to accomplish its objective of releasing its cell therapy goods in Japan sooner than anywhere else in the globe would be possible. Due to this distinctive chance, the next-phase tests of the Company will be carried out in Japan.
Bosley, which has been a world champion in hair restoration for over 40 years, is launching the Bosley Revitalizer Laser Hair Restoration system, which encourages hair growth for everyone at home. The Bosley Revitalizer is a mobile, wearable laser treatment device that utilizes low-level laser therapy (LLLT) clinical resistance equipment to assist prevents hair loss, improve and thicken hair.
In the hair transplant services industry, manufacturers are making attempts to maintain their impactful business presence. Major key players are more focused on strategic techniques like novel product launches, regional expansion and capacity; steady growth and demand for collaboration and partnerships are expected to drive the market. For example, laser devices from HairMax Inc. have been approved by ANVISA, which has been very advantageous for the growth and expansion of the companys product portfolio.
Escalating brand approvals improves the accessibility of business products and thus enhances the market growth. In addition, some of the other factors affecting and deducing market growth are media influence, film and fashion sector development, beauty and appearance peer stress, etc. In deriving market growth, some health aspects also perform an important part. These are accidents, genetic problems, illnesses such as cancer or chemotherapy that trigger hair loss combined with the increasing amount of hair transplant clinics and services that drive the expansion of the industry.
The report highlights the adoption of Hair Restoration Services globally. Based on Service Provider, the market is segmented into Hospitals, Clinics and Surgical Centers. Based on Gender, the market is segmented into Male, and Female. Based on Service type, the market is segmented into Follicular Unit Extraction, Follicular Unit Transplantation, Laser Treatment, Follicular Unit Strip Surgery and Other services. The report also covers geographical segmentation of Hair Restoration Services market. The geographies included in the report are North America, Europe, Asia Pacific, and Latin America, Middle East & Africa. For the better analysis, the geographies are segmented into countries.
The major market players expanding their reach in the global hair restoration services market are Allergan PLC, Direct Hair Implantation Ltd., Bosley, Inc. (Aderans Company Limited), National Hair Centers (GD&D Hair Solutions), Venus Concept Ltd. (NeoGraft Solutions), Lexington Intl. LLC, Bernstein Medical PC, Theradome, Inc., Elite Hair Restoration Ltd. and IllumiFlow.
Scope of the Study
Market Segmentation:
By Service Provider
Hospitals
Clinics
Surgical Centers
By Gender
Male
Female
By Service Type
Follicular Unit Extraction
Follicular Unit Transplantation
Laser Treatment
Follicular Unit Strip Surgery
Other services
By Geography
North America
o US
o Canada
o Mexico
o Rest of North America
Europe
o Germany
o UK
o France
o Russia
o Spain
o Italy
o Rest of Europe
Asia Pacific
o China
o Japan
o India
o South Korea
o Singapore
o Malaysia
o Rest of Asia Pacific
Latin America, Middle East and Africa (LAMEA)
o Brazil
o Argentina
o UAE
o Saudi Arabia
o South Africa
o Nigeria
o Rest of LAMEA
Companies Profiled:
Allergan PLC
Direct Hair Implantation Ltd.
Bosley, Inc. (Aderans Company Limited)
National Hair Centers (GD&D Hair Solutions)
Venus Concept Ltd. (NeoGraft Solutions)
Lexington Intl. LLC
Bernstein Medical PC
Theradome, Inc.
Elite Hair Restoration Ltd.
IllumiFlowRead the full report: https://www.reportlinker.com/p05826085/?utm_source=GNW
About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.
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What is the role of genetic counseling in breast cancer care? – Baylor College of Medicine News
When actress Angelina Jolie revealed that she was a carrier of a genetic mutation that increases her risk of developing breast cancer and ovarian cancer, many women started discussing their own hereditary cancer risk. But are all breast cancers genetic?
About 5 to 10% of breast cancers are hereditary, so the majority of diagnoses occur by chance, said Cathy Sullivan, a certified genetic counselor with the Breast Care Center at Baylor College of Medicine.
Individuals who have been diagnosed with breast cancer are often referred to see a genetic counselor, especially in cases where there is a family history of cancer.
The first thing we do is review the patients history to see if the family fits any of the characteristics of a hereditary cancer syndrome, she said. If they do, we talk to them about genes, different options to help them decide if they want testing, and how the results will impact them and their family.
The most common genetic predispositions to breast cancer are mutations in the BRCA1 and BRCA2 genes. Women of Ashkenazi Jewish descent are also at a higher risk for having these mutations.
Individuals who have the BRCA gene mutation can go on certain treatments that will likely be more effective for them. Also, knowing they have these mutations will give us an idea of whether or not they have a higher risk for developing a second breast cancer.
Many of the genes that are associated with breast cancer are also associated with an increased risk of developing other types of cancer.
The BRCA1 gene impacts other tissues, such as the ovaries. Men with a BRCA mutation also have an increased risk of male breast cancer and prostate cancer, Sullivan said.
Cancer risk varies depending on the gene. For example, women with the BRCA1 mutation have a higher risk of developing ovarian cancer, whereas women with the BRCA2 mutation have a higher risk of developing pancreatic cancer.
If you have a family history of breast cancer, Sullivan says genetic testing can be useful but its important to start with an affected family member first if possible.
When we see unaffected patients, they often have living family members with a history of breast cancer. It is always best to start genetic testing with someone who has had cancer, so we can determine if the cancer is associated with one of these genes.
Sullivan says unaffected individuals can be tested, but a negative result is not as impactful because it isnt known if there is a mutation in the family that wasnt inherited.
A lot of times, we see familial clusters of breast cancer that arent linked to a specific gene, she said. We have computerized programs that incorporate an individuals family history, genetic testing that has occurred among family members, and their own personal risk factors for breast cancer. These models generate a personalized risk assessment for breast cancer and compare that to the average womans lifetime risk.
This information is often used to determine if there is a need for earlier screenings and preventive care.
For unaffected individuals, sometimes this risk assessment is more significant than the actual genetic testing, because most of the time they will test negative. But we know they are likely still at a higher risk, so we incorporate it into the model to make a screening plan for them.
While it may be tempting to purchase an at-home genetic test, Sullivan says women who are interested in testing should instead talk to their doctor and a certified genetic counselor.
There are so many different tests available and you want to make sure you are getting the appropriate test. Many of the at-home genetic tests are incomplete or inaccurate.
Sullivan also emphasizes that testing positive for a gene mutation does not automatically mean cancer will develop in the future. Many women live their whole lives with these mutations and never develop cancer. Testing is a just tool of information that you can use to be more proactive as you get older.
Sullivan is an instructor in the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine. Learn more about genetic testing and counseling services at Baylor or call (713) 798-1999.
See more services at the Breast Care Center.
View breast cancer clinical trials at Baylor.
-By Nicole Blanton
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What is the role of genetic counseling in breast cancer care? - Baylor College of Medicine News
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Online tool speeds response to elephant poaching by tracing ivory to source – University of Illinois News Bureau
With their colleagues, U. of I. animal sciences professor Alfred Roca, seated, with, from left, technician Cory Green and graduate students Tolu Perrin-Stowe and Alida de Flamingh, developed an online tool that can trace the origins of poached ivory more quickly than previous methods.
Photo by Fred Zwicky
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CHAMPAIGN, Ill. A new tool uses an interactive database of geographic and genetic information to help authorities quickly identify where the confiscated tusks of African elephants were originally poached.
Developed by an international team of researchers, the Loxodonta Localizer matches genetic sequences from poached ivory to those stored in the database. It relies on genetic information from a small, highly variable region of mitochondrial DNA from African elephants.
The work is reported in the Journal of Heredity.
Mitochondrial DNA is passed only from females to their offspring. This makes it very useful for tracking elephants, since the herds are matrilineal and females do not disperse, said University of Illinois animal sciences professor Alfred Roca, who led development of the new tool.
The females kick the males out of the herd at puberty and the males have to go out on their own, Roca said. Females stay with the herd and that herd tends to stay in certain localities. Roca is an affiliate of the Carl R. Woese Institute for Genomic Biology at Illinois.
African elephant herds are matrilineal only the males disperse.
Photo by Michael Jeffords and Susan Post
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Illegal hunting is a major threat to the elephants of Africa, with more elephants killed by poachers than die from natural causes, the researchers wrote in a paper describing the online tool. Between 2006 and 2016, the number of African elephants declined by about 110,000, and the rate of poaching has been increasing since 2008. Today, about 415,000 African elephants remain.
A recent analysis revealed that elephant populations in 73 locations believed to carry half of Africas elephants are less than 25% of what they would be if poaching were not occurring.
Current approaches to identifying the source of confiscated elephant tusks include the use of several genetic markers from nuclear DNA, which is inherited from both parents. Nuclear DNA can help identify individual elephants. But determining an elephants geographic origin with nuclear DNA is a complicated task requiring more genetic data and statistical modeling, Roca said.
Authorities often burn confiscated ivory. This pile of ivory ash was left in Tarangire National Park in Tanzania as a statement against poaching.
Photo by Michael Jeffords and Susan Post
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If you look at nuclear genes, theres very little difference across central Africa; the forest elephants all look pretty much the same, he said. But if you look at the mitochondrial DNA, there are these regional groupings.
The variable region of mitochondrial DNA contains more recent mutations than other parts of the genome and so provides a record of recent genetic changes between groups. This makes it an ideal tool for distinguishing between elephant populations
Ivory contains small amounts of DNA, he said. Its dead, but the cells are embedded in the bone. Sanger sequencing, a technique to sequence the small region of mitochondrial DNA, is cheap and easy to do, Roca said.
For the most part, anyone can generate a Sanger sequence anywhere in the world, he said. You can get a result within six days with this one genetic marker.
Mitochondrial DNA, which is inherited only from the mother, is an ideal marker for determining the origin of poached ivory, researchers said.
Photo by Michael Jeffords and Susan Post
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The Loxodonta Localizer contains sequences of mitochondrial DNA from more than 1,900 African forest and savanna elephants. The sequences were compiled from previously published studies of African elephants. Kai Zhao, who was a graduate student in Rocas lab, developed the software. Cory Green, a technician, spent nearly a year verifying the data and making sure the geographic localities and sequences matched up in the database.
The researchers tested the Loxodonta Localizer with mitochondrial DNA sequences from ivory seized in Malaysia in 2012. The ivory had already been independently analyzed and assigned a geographic origin based on nuclear DNA markers. The two assessments agreed, but the new software allowed for a faster and cheaper analysis, Roca said. It also offered a more precise geographic picture of the origin of tusks because the seizures included relatively rare mitochondrial DNA sequences pointing to the same geographic regions.
Being able to determine the source of poached ivory within days of its recovery can speed the response to poaching in new or unexpected areas, Roca said. The information can tie individual smugglers to broader smuggling networks, as the tool can also quickly point investigators to the tusks that will be most helpful to sequence more fully to establish, for example, whether two tusks in different shipments are from the same elephant.
The researchers hope that scientists across the African continent will begin to sequence their elephants and add those to the database.
Right now, I believe we have about one out of every 200 elephants in Africa included in the database, Roca said. What we really need are more samples from more locations, so that the database holds as many of the rare but geographically informative sequences as possible.
The U.S. Fish and Wildlife Service African Elephant Conservation Fund, the conservation group known as TRAFFIC, the U.S. Department of State and the U.S. Agency for International Development supported this work.
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Online tool speeds response to elephant poaching by tracing ivory to source - University of Illinois News Bureau
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Red deer are evolving to give birth earlier in the year due to climate change – inews
NewsEnvironmentThe animal's genetic make-up has changed significantly in recent decades
Tuesday, 5th November 2019, 7:00 pm
Scientists have found the first evidence that wild animals are rapidly evolving to give birth earlier in the year in response to climate change.
Red deer on the Scottish Isle of Rum are giving birth 12.3 days earlier in the year, on average, than they were four decades ago - and evolution is at least partly responsible, a new study finds.
Researchers have analysed 45 years of data and identified a significant change in the genetic makeup of female red deer - known as hinds - with genes for breeding earlier becoming far more common over the period.
The genes are thought to bring forward the timing of oestrus - or heat - in the female, increasing the chance that they will become pregnant and give birth earlier.
Rutting season brought forward
The change is a response to an earlier rutting season - with males competing for females a little sooner each year as warmer temperatures bring forward the grazing season.
"This is the best evidence yet for a genetic change in the timing of events in the wild. Usually people think of evolution as very slow but this seems quite fast," said Professor Josephine Pemberton, of the University of Edinburgh.
Hinds give birth to a single calf a year, conceiving in the autumn and giving birth in the summer.
'This is the best evidence yet for a genetic change in the timing of events in the wild'
Josephine Pemberton
Genes have played a significant part in bringing forward the birth dates but non-genetic effects of the warming weather on the deer's behaviour and physiology are also thought to have a role, the researchers said.
Sally Thomas, of Scottish National Heritage, which manages the Isle of Rum nature reserve where the deer live, said: "These findings are a fascinating example of the impact climate change may be having on wildlife."
Timothee Bonnet, of the Australian National University, who led the study, said: "This is one of the few cases where we have documented evolution in action, showing that it may help populations adapt to climate warming."
The study was published in the journal PLOS Biology. It also involved scientists from the universities of St Andrews and Cambridge.
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Red deer are evolving to give birth earlier in the year due to climate change - inews
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Novel Surgery May Prevent Lymphedema in Patients with Breast Cancer – UC San Diego Health
Of the 3.5 million current breast cancer survivors in the United States, one in five will be diagnosed with a painful swelling condition called lymphedema, which can occur as a consequence of lymph nodes under the arms being removed, also known as axillary lymph node dissection. UC San Diego Health now offers a novel surgical procedure to help prevent this debilitating condition.
Frederic Kolb, MD, plastic surgeon, UC San Diego Health
While the majority of patients do not experience complications from lymph node removal, it can be devastating for those who do. Immediate lymphatic reconstruction is a preventive procedure to restore lymphatic connections in the arm, said Frederic Kolb, MD, plastic surgeon at UC San Diego Health. This delicate surgery is performed at the same time the lymph nodes are removed and tested for cancer. Instead of treating patients after lymphedema presents itself, we hope to prevent the condition for patients who may be at risk.
During lymph node dissection, Kolb and his team map the drainage routes of the nodes in the upper arm. The team reconnects any disrupted channels by creating a by-pass to prevent swelling. Using a microscope, the team reroutes the tiny vessels, many less than the thickness of a dime.
This microsurgical technique re-plumbs the lymphatic system to allow for the normal flow and drainage of lymphatic fluid, said Christopher Reid, MD, plastic surgeon, UC San Diego Health. It is intended to prevent the chronic limb swelling and infection associated with breast cancer-related lymphedema. The technique may also be applicable to prevent leg lymphedema caused by lymph node dissections in the groin.
As a cancer surgeon, my primary goal is to accurately stage the cancer to identify which patients need more aggressive treatment, Sarah Blair, MD, surgical oncologist at UC San Diego Health. In some patients, significant lymph node dissection can unintentionally result in damage to healthy tissue. With this procedure, we can help prevent lymphedema and give the patient a better overall experience and outcome.
The lymphedema prevention surgery represents one of several emerging microsurgical techniques being used to care for patients with breast cancer. Certified lymphedema therapists are also available to help patients prevent or manage the condition through exercise and massage.
Christopher Reid, MD, plastic surgeon, UC San Diego Health
The Comprehensive Breast Health Center has developed protocols for pre-operative evaluation of patients and immediate postoperative evaluation of lymphedema and range of motion issues associated with breast cancer treatment, said Anne Wallace, MD, director, Comprehensive Breast Health Center. Data shows that both early assessment and treatment by occupational therapists after breast cancer treatment leads to improved physical outcomes.
For more than two decades, UC San Diego Healths nationally recognized Comprehensive Breast Health Center has offered a multidisciplinary program to treat female and male patients with any kind of breast issue including all stages of cancer. From detection to diagnosis and treatment, the program uses the patients genetic profile to customize treatment options, including surgery, chemotherapy, hormonal therapy, radiation and reconstruction.
The surgical team offers multiple options to help the patient safely achieve their desired outcome. This includes advanced oncoplastic options for patients desiring breast conservation to the full scope of implant-based and non-implant-based reconstruction using a patients own tissue after mastectomy. The team approach allows for shared decision making between the patient and the plastic surgeon who has specific expertise in any of these choices.
When needed, patients have access to a specialized recovery unit inside Jacobs Medical Center. Care is provided by a sub-specialty trained group of nurses who provide close and continuous monitoring of tissue reconstruction, as well as overall well-being. The team also includes anesthesiology pain management experts who have specialized training in block use and other postoperative pain management regimens to decrease pain, shorten hospital stays, and reduce the need for opioid pain medication.
UC San Diego Health is one of only 50 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country and the only such center in San Diego County.
To learn more about this surgery and the Comprehensive Breast Health Center visit health.ucsd.edu.
UC San Diegos Studio Ten 300 offers radio and television connections for media interviews with our faculty. For more information, email .(JavaScript must be enabled to view this email address).
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TEDxVanderbiltUniversity to feature seven members of the Vanderbilt community – The Vanderbilt Hustler
Vanderbilt will be hosting TEDxVanderbiltUniversity on Nov. 10 at 1:00 p.m. in Sarratt Cinema.
Organized independently of the nonprofit TED, the Vanderbilt Student Leadership Development Team operates the event in the style of a TED Conference, where speakers are given just a few minutes to share ideas worth spreading. The event will feature seven speakers from the Vanderbilt community discussing topics ranging from unemployment in the autism community to music in presidential elections. The Hustler spoke to each TEDx presenter about their talk and inspiration.
Sarah Jordan Welch
Sarah Jordan Welch (Photo courtesy tedxvanderbiltuniversity.com)
A licensed social worker and Vanderbilt staff member, Sarah Jordan Welch of Project Safe will be speaking about the experiences of sexual assault survivors in her talk Welcome to the Trauma Club.
Most people, whether they know it or not, know somebody whos been impacted by sexual violence, Welch said, and I think that sometimes the narratives that get shared are of very specific perspectives or particular identities. My intention with the talk is to have anyone who is coming to it who is a survivor have at least one moment of resonance, or one moment of feeling like they can relate to something that Ive said.
As a survivor of sexual assault, one of the challenges Welch faces daily in her job is how to support the survivors she works with while also taking care of herself. In choosing to give a TED talk, Welch decided that despite the difficult content, it was worth speaking out because of the possibility of helping others.
If my talk gets to some random person in Wyoming who feels a connection, thats kind of amazing that theres somebody who Ive never met, who likely I will never meet, that feels like their story has been highlighted or that they have value and worth and are important, Welch said.
Project Safe staff and resources will be available at the TED event.
If my talk gets to some random person in Wyoming who feels a connection, thats kind of amazing that theres somebody who Ive never met, who likely I will never meet, that feels like their story has been highlighted or that they have value and worth and are important.
Sarah Jordan Welch
Claire Barnett
Claire Barnett (Photo courtesy tedxvanderbiltuniversity.com)
Vanderbilt graduate Claire Barnett (19) is the Communications Coordinator for the Frist Center for Autism and Innovation, a Vanderbilt initiative. Barnett is also the former Multimedia Director of The Hustler. Barnetts TED talk, Why autistic unemployment is so high and what we can do about it is about the unemployment of autistic people and the valuable, unique skills individuals with autism can offer to an employer. Part of Barnetts work is self-advocacy as an autistic adult. In doing this, she said, Ive seen it open peoples minds a little bit to think about neurodiversity differently.
Theres a very specific set of challenges that a lot of autistic people face as they try to get into the workforce, Barnett said.
Working in an advocacy and research role at the Frist Center, Barnett examines how people with autism can reach their full potential at work and what management skills and resources are necessary for employers to help them do this. In her talk, she will also discuss ways to change the unemployment rate of people on the spectrum based on her own knowledge, research and what shes learned at the Frist Center.
Krystal Tsosie
Krystal Tsosie (Photo courtesy tedxvanderbiltuniversity.com)
A Vanderbilt Ph.D. student, educator and advocate for genetic and data sovereignty, Krystal Tsosies experiences as an Indigenous (Din/Navajo) geneticist and bioethicist inform her TED talk, Our DNA is Not Our Identity.
As a researcher and scientist, Tsosie examines womens health through genomic studies in a North Dakota tribal community, but her experiences have led her to the conclusion that biomarkers and genetics do not definitively represent identity or what ideas of identity should be based on.
Tsosies talk, which considers community, identity and their definitions, argues that experiences are what shape us and determine kinship, not labels based on biological or cultural ideas.
We are not just one identity, and that identity is not based off of a DNA test kit. We are many things, Tsosie said. We belong to multiple communities, and none of those things are biologically defined or may not be biologically defined.
Kamala Varma
School of Engineering and College of Arts and Science senior Kamala Varmas talk,
Jair PowellKamala Varma (Photo courtesy tedxvanderbiltuniversity.com)
Lessons in Creativity from a Computer Artist Named Arthur, is based on a project she did in her free time to learn more about artificial intelligence. In 952 lines of code, Varma tried to create a system that went a step beyond current AI artists.
A lot of the existing AI systems that generate art are very focused on the visual, and so if visually it looks [like] art and it looks cool, then thats considered a success, Varma said. I tried to add more meaning to the art, so have it actually make art based off of a theme, and try and get it to interpret that theme and then make art based on that theme.
Varma said she doesnt have a definition for art when it comes to her computer programs products. She explained that trying to have a computer produce art is complex and judging the quality of the result can be a challenge. Instead, Varma drew inspiration in her project from her own artistic process, as well as those of Pablo Picasso and Andy Warhol.
Im trying to mimic the human artistic process, which I dont think existing AI systems do, they just focus on getting the cool result, Varma said.
Troy Jiang
Troy Jiang (Photo courtesy tedxvanderbiltuniversity.com)
Troy Jiang is a senior in the College of Arts and Science, double majoring in Mathematics and Communication of Science and Technology. Jiangs talk Lets Talk About (the Potential) of Dating Apps, will use stories and research in order to discuss both the potential and dangers surrounding dating apps, specifically Tinder and Grindr.
Dating apps provide unprecedented opportunities for us, but there are actions that we must take to leverage their full potential, Jiang said. With proper management and use, we can bring out the great potential of dating apps and bring the world together
TIME ranked Vanderbilt as the 28th most popular school for male Tinder use, with the amount of people on dating apps only increasing, Jiang said.
Dating platforms have become a critical aspect of society. For many Vanderbilt students who are interested in the technology and social changes, dating platforms an exciting opportunity for us to learn and to potentially contribute to improving these technologies, Jiang said.
Tommy Oswalt (Photo courtesy tedxvanderbiltuniversity.com)
Tommy Oswalt
Tommy Oswalt, a senior in the College of Arts and Science, will deliver Why Music Matters in the 2020 U.S. Presidential Election analyzing how presidential candidates utilize music throughout their campaigns in order to display policy, relatability, experience and presidentiality. By presenting President Barack Obamas 2012 campaign playlists, Oswalt will provide the audience with things to listen for in the 2020 election.
Oswalt found inspiration through his parents: father as a local politician and mother as a musician.
I found both music and politics to be integral components to my upbringing, Oswalt said. Every day, U.S. voters are constantly inundated with countless forms of media that attempt to make sense of both the candidates and events of the campaign.
This talk aims to offer another lens through which people can analyze the 2020 election for themselvesthe lens of campaign music.
Katy Friedman (Photo courtesy tedxvanderbiltuniversity.com)
Katy Friedman
Vanderbilt graduate Katy Friedman (94) is a grief therapist with a private practice in St. Louis. Friedmans talk, Scared to Death and Showing Up Anyway: The Heroism of Being There with Grief and Grievers, will discuss her work in hospice and as a grief therapist and explain how those occupations have given her invaluable experience being with grieving people.
I notice other people seem to be afraid of this. I am too, but my work is to practice showing up when I am afraid or feel inadequate. I want to encourage other people to do the same, Friedman said.
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TEDxVanderbiltUniversity to feature seven members of the Vanderbilt community - The Vanderbilt Hustler
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Physician Goes Behind The Scenes To Write Compelling Story About Treating Patients With New Cancer Gene Therapy – Kaiser Health News
Ilana Yurkiewicz, a physician and medical journalist at Stanford University, explains why CAR-T is only used in patients with certain cancers and tries to answer why they havent yet been shown to work against solid tumors in an UnDark article. Public health news is on breast cancer tests, fecal matter transplants, Zantac recalls, white male life expectancy, skin rashes, growing up with HIV, a retracted HIV study, live-streaming a mammogram, and how to get a good night's sleep, as well.
The Washington Post:Science Author Digs Into The Story About A Revolutionary Cancer Treatment Used In ImmunotherapyIn 2017, CAR-T therapy made waves as the first gene therapy to be approved by the Food and Drug Administration. In a fascinating article for Undark, Ilana Yurkiewicz, a physician at Stanford University, plunges into the fraught history and future of a cancer treatment thats as radical as it is risky. Unlike chemotherapy or radiation, which attack cancer directly, CAR-T engineers patients immune cells so they can do it themselves. (Blakemore, 11/2)
Bloomberg:Blood Test To Detect Breast Cancer Could Be Five Years AwayA blood test that may be able to detect breast cancer up to five years before symptoms develop could be available by 2025 if development is fully funded, U.K. researchers said. Doctors at the Centre of Excellence for Autoimmunity in Cancer at the University of Nottingham compared blood samples from 90 patients being treated for breast cancer with the same number from a control group without the disease to measure the bodys immune response to substances produced by tumor cells. Theyre now testing samples from 800 patients for nine markers and they expect the accuracy of the test to improve. (Marley, 11/3)
Stat:FDA To Consider New Evidence, Risks Behind Fecal Matter TransplantsOn Monday, the Food and Drug Administration will host its first formal discussion about fecal microbiome transplants in years less than a week after a paper in the New England Journal of Medicine disclosed new details about the first death ever conclusively linked to the procedure, often abbreviated to FMT. The Monday meeting, which will be happening at the FDAs headquarters in White Oak, Md., will cover the safety and effectiveness of FMT as a treatment for repeated (and potentially fatal infections) of Clostridium difficile bacteria. (Sheridan, 11/1)
Stat:FDA: Zantac Does Not Form A Carcinogen, But Some Pills Should Be RecalledAfter running simulated testing, the Food and Drug Administration says it has not found evidence that Zantac and similar heartburn medicines form a possible carcinogen in patient stomachs or small intestines. Nonetheless, the agency also indicated some of the medicines contain higher than acceptable levels of NDMA, and asked manufacturers to voluntarily withdraw those pills. The move marks the first time the FDA has suggested drug makers should recall their heartburn medicines, which are called ranitidines, after opening a probe several weeks ago. (Silverman, 11/1)
CBS News:Life Expectancy For American Men Drops For A Third YearLife expectancy for American men dropped for a third consecutive year, with the National Center for Health Statistics citing an increase in so-called "deaths of despair," such as the rise in drug overdose deaths.The average lifespan of men in the U.S. dipped to 76.1 years in 2017 (the latest data available), amounting to a four-month decline in life expectancy since 2014. The findings shed additional light on economic research into the sharp increase in recent years in deaths from overdoses and suicides among white men with less education. (Picchi, 10/31)
NPR:Rashes Can Look Very Different On Different Shades Of SkinWhen Ellen Buchanan Weiss' son was about a year old, he broke out in a rash little bumps that appeared to be hives. So Buchanan Weiss did what a lot of new parents do: She turned to the Internet to find images that matched the rash she was seeing on her little boy. "I'm trying to figure out would I be paranoid if I went to the doctor at this point? Is that a reasonable thing to do? So I started googling it," says Buchanan Weiss, who lives with her family in Raleigh, N.C. (Prichep, 11/4)
The New York Times:Armed With A New Laptop, He Is On A Path To A DegreeWhen he was growing up, Warren Williams wanted nothing more than to play baseball and watch Scooby-Doo. I just wanted to be normal, like other kids, he said. But his health often took the joy out of his childhood. Mr. Williams, 26, was born with H.I.V. One of his earliest memories is from when he was 4: A mass had developed in his chest and he was rushed to a hospital to have open-heart surgery. The doctors gave him a stuffed Barney the dinosaur to keep by his side on the operating table. (Aridi, 11/3)
The Associated Press:Scientists Retract Study Suggesting Mutation Shortens LifeScientists have retracted a study that appeared to show people may live shortened lives if they carry a DNA mutation that reduces their chance of HIV infection. The study focused on people who carry a specific mutation in both copies of a gene called CCR5. It was published in June in the journal Nature Medicine and covered by news outlets including The Associated Press. (11/1)
The Washington Post:Ali Meyer Records Breast Cancer Diagnosis Live On Facebook For KFOR NewsAli Meyer live-streamed her first mammogram with other women in mind. The veteran journalist was wary of making herself the center of the story, she remembers, but she wanted to remind people to schedule their own appointments so they could catch breast cancer early. Then a nurse came in to say the radiologist would prefer to see Meyer with the camera off. In private, the doctor told Meyer she would need more imaging. At 40 years old, she realized, she might have cancer. (Knowles, 11/2)
NPR:How To Fall Asleep: These Daytime Habits Will HelpIf turning back the clock an hour for the end of daylight saving time leaves you feeling jangly, imagine the toll that chronic sleep loss can take on your health. The evidence has piled up. We all need good sleep. And our bodies crave regular routine. Without it, we set up ourselves for increased risk of anxiety, depression, weight gain, even dementia. (Aubrey, 11/3)
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Physician Goes Behind The Scenes To Write Compelling Story About Treating Patients With New Cancer Gene Therapy - Kaiser Health News
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Humanigen"s abstracts on lenzilumab to be presented at the American Society of Hematology – Proactive Investors USA & Canada
Humanigen is developing a portfolio of cell and gene therapies for the treatment of cancers through its novel GM-CSF gene-knockout platforms
() said Wednesday that two abstracts on its promising key drug candidate lenzilumab will be presented at the upcoming annual meeting of the American Society of Hematology, in Florida.
The Burlingame, California, companys lenzilumab, is a recombinant monoclonal antibody that neutralizes a substance that promotes growth of white blood cells, but is also tied to inflammations that can occur during CAR-T therapies and lead to side effects.
Pre-clinical work shows lenzilumab is effective in preventing the side effects and may make the CAR-T therapies more effective, according to Humanigen.
In a statement, the clinical-stage biopharmaceutical company said the two abstracts are focused on granulocyte-macrophage colony-stimulating factor (GM-CSF) gene knockout and GM-CSF neutralization with lenzilumab, the company's proprietary Humaneered anti-human-GM-CSF immunotherapy.
Both abstracts have been accepted for presentation at the American Society of Hematology on December 9, at the Orange County Convention Center, in Orlando, Florida.
Humanigen said that using a xenograft model for relapsed acute lymphoblastic leukemia (ALL), which is a type of cancer of the blood and bone marrow that affects white blood cells, treatment with GM-CSF k/o CART19 resulted in improved overall survival compared to wildtype CART19.
The lack of myeloid cells in this model pointed to an intrinsic effect of GM-CSF on CAR-T cells, said the company.
"These results strongly indicate that CAR-T cells increase expression of GM-CSF receptor subunits when activated, resulting in modulation of CAR-T function, said Humanigen CEO Durrant.
Collectively, these results illuminate a novel mechanism for a direct modulatory effect of GM-CSF on activated CAR-T cells that helps to explain the improved survival with GM-CSF neutralization or knockout," he added.
Durrant, a medical doctor and MBA who assumed the role of CEO in March 2016, said the results of the company sponsored phase I study reinforce the favorable safety profile of lenzilumab even in patients with chronic myelomonocytic leukemia (CMML), a rare type of blood cancer,who have undergone several cycles of immunosuppressive therapy.
"As with all prior lenzilumab clinical trials, no serious treatment related adverse events were observed," said Durrant.
Throughout the study there were no reported instances of dose limiting toxicities or adverse events grade 3 or higher related to the study drug. Additionally, of four subjects with NRAS mutations at screening, three either achieved clinical benefit or had clinical meaningful bone marrow myeloblast reductions, he added.
Humanigen is developing a portfolio of next-generation cell and gene therapies for the treatment of cancers through its novel GM-CSF neutralization and gene-knockout platforms.
The companys immediate focus is combining FDA-approved and development stage CAR-T therapies with lenzilumab, the companys proprietary anti-human-GM-CSF immunotherapy, which is its lead product candidate.
Contact Uttara Choudhury at[emailprotected]
Follow her onTwitter:@UttaraProactive
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Humanigen"s abstracts on lenzilumab to be presented at the American Society of Hematology - Proactive Investors USA & Canada
Recommendation and review posted by Bethany Smith
New data to be presented at ASH 2019 highlight Sanofi’s commitment to treat challenging blood cancers and rare blood disorders – PRNewswire
CAMBRIDGE, Mass., Nov. 6, 2019 /PRNewswire/ --New clinical data from Sanofi's oncology and rare blood disorders portfolios and pipelines will be featured, including four oral presentations and 18 posters, at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition from December 7-10 in Orlando, FL.
"Blood cancers and rare blood disorders account for some of the most challenging diseases to treat, and patients often have limited therapeutic options," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "Drawing upon our deep expertise in hematology, and one of the industry's more robust research and development programs actively working to address numerous hematologic conditions, we are excited to present new data at ASH that we believe demonstrate our commitment to advancing science and improving the lives of patients we serve."
Advancing the understanding of multiple myeloma in difficult-to-treat populationsIsatuximab: In the area of multiple myeloma, analyses from the pivotal ICARIA-MM trial for isatuximab, an investigational anti-CD38 monoclonal antibody, will highlight depth of response and associated long-term outcomes (abstract #3185), health-related quality of life (abstract #1850), and outcomes in an elderly patient population (abstract #1893). The ICARIA-MM clinical trial serves as the basis of a Biologic License Application for isatuximab for the treatment of relapsed/refractory multiple myeloma, which is currently under review by the U.S. Food and Drug Administration with a target action date for a decision of April 30, 2020. A Marketing Authorization Application for isatuximab was also accepted for review by the European Medicines Agency in the second quarter of 2019. Read more about our oncology data at ASH.
Striving to address unmet needs for people with rare blood disorders Cold Agglutinin Disease and Immune Thrombocytopenic Purpura:New analyses of transfusion practices in the U.S. (abstract #3559) and mortality risks associated with cold agglutinin disease (CAD) (abstract #4790) will underscore the seriousness of this rare and debilitating hemolytic anemia. Sutimlimab, an investigational monoclonal antibody designed to inhibit C1s, is being investigated as a potential first-in-class treatment for CAD in two pivotal Phase 3 studies. An oral presentation on sutimlimab will also explore its potential in immune thrombocytopenic purpura (ITP) patients without adequate response to two or more prior therapies (abstract #898). ITP represents a second indication being investigated for sutimlimab.
Hemophilia:Final data from a Phase 1 study (abstract #625) of BIVV001 (rFVIIIFc-VWF-XTEN) evaluating the safety and pharmacokinetics of repeated dosing will be shared in an oral presentation. BIVV001 is the first and only investigational von Willebrand (VWF)-independent factor VIII therapy that is designed to provide high sustained factor activity and extend protection from bleeds with once weekly dosing for people with hemophilia A. A Phase 3 study of BIVV001 is expected to be initiated by year-end. BIVV001 is being developed in collaboration with Sobi.
Additional analysis of the ongoing Phase 2 open-label extension study (abstract #1138) of fitusiran, a potential first-in-class, once-monthly, fixed-dose subcutaneously administered RNA interference therapeutic targeting antithrombin (AT) will also be shared. Fitusiran is the first and only monthly investigational therapy in Phase 3 development for the treatment of both hemophilia A and B, with and without inhibitors.
Hemoglobinopathies:New pre-clinical and clinical research on our pipeline of investigational, zinc finger nuclease ex vivo gene-edited cell therapies for sickle cell disease (BIVV003) and beta thalassemia (ST-400) will be shared in multiple presentations. BIVV003 and ST-400 are being developed in collaboration with Sangamo Therapeutics, Inc.
Acquired Thrombotic Thrombocytopenic Purpura;Additional presentations include results from studies on Cablivi (caplacizumab-yhdp), our first-in-class approved treatment, in combination with plasma exchange and immunosuppressive therapy, for adult patients with acquired thrombotic thrombocytopenic purpura (aTTP).
Oncology Poster Presentations:
Isatuximab
Efficacy of Isatuximab with Pomalidomide and Dexamethasone in Elderly Patients with Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis (Dr. Fredrik Schjesvold; Saturday, December 7, 2019: Poster Presentation, 5:30-7:30 p.m. ET)
Depth of Response and Response Kinetics in the ICARIA-MM Study of Isatuximab/Pomalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma (Dr. Cyrille Hulin; Sunday, December 8, 2019: Poster Presentation, 6:00-8:00 p.m. ET)
Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Treated with Isatuximab plus Pomalidomide and Dexamethasone: ICARIA-MM Study (Katherine Houghton; Saturday, December 7, 2019: Poster Presentation, 5:30-7:30 p.m. ET)
Exposure-response Analyses and Disease Modeling for Selection and Confirmation of Optimal Dosing Regimen of Isatuximab in Combination Treatment in Patients with Multiple Myeloma (Dr. Fatiha Rachedi; Saturday, December 7, 2019: Poster Presentation, 5:30-7:30 p.m. ET)
The Relationship Between Baseline Biomarkers and Efficacy of Isatuximab in Combination with Pomalidomide and Dexamethasone in RRMM: Insights from Phase 1 and Phase 3 studies (Dr. Paul Richardson; Sunday, December 8, 2019: Poster Presentation, 6:00-8:00 p.m. ET)
Evaluating Isatuximab Interference with Monoclonal Protein Detection By Immuno-Capture and Liquid Chromatography Coupled to High Resolution Mass Spectrometry in the Pivotal Phase 3 Multiple Myeloma Trial, ICARIAMM (Dr. Greg Finn; Sunday, December 8, 2019: Poster Presentation, 6:00-8:00 p.m. ET)
Rare Blood Disorders Oral and Poster Presentations:
Cold Agglutinin Disease and Immune Thrombocytopenic Purpura
Inhibition of the Classical Pathway of Complement With Sutimlimab in Chronic Immune Thrombocytopenic Purpura Patients Without Adequate Response to Two or More Prior Therapies - #898 - Monday, December 9, 2019,6:15 PM 7:45 PM(ET) Oral Presentation - Room W307
Cold Agglutinin Disease Transfusion Practices in the United States: An Electronic Medical RecordBased Analysis- #3559 - Monday, December 9, 2019, 6:00 PM 8:00 PM (ET)
Mortality Among Patients With Cold Agglutinin Disease in the United States: An Electronic Medical Record (EMR)Based Analysis - #4790 (abstract only)
Hemophilia
Phase 1 Repeat Dosing with BIVV001: The First Investigational Factor VIII Product to Break through the Von Willebrand FactorImposed Half-Life Ceiling - #625 Monday, December 9, 2019 10:30 AM 12:00 PM (ET) - Oral presentation - Room W415A
Cryo-EM Structure of BIVV001 Reveals Coagulation Factor VIII-Von Willebrand Factor D'D3 Interaction Mode- #94- Saturday, December 7, 2019, 9:30 AM 11:00 AM (ET) - Oral presentation Room W414AB
Fitusiran, an RNAi Therapeutic Targeting Antithrombin to Restore Hemostatic Balance in Patients with Hemophilia A or B with or without Inhibitors: Management of Acute Bleeding Events #1138 - Saturday, December 7, 2019, 5:30 PM - 7:30 PM(ET)
Patients' and Caregivers' Preferences for Different Hemophilia A Treatment Attributes- #2122 - Saturday, December 7, 2019, 5:30 PM - 7:30 PM (ET)
Acquired Thrombotic Thrombocytopenic Purpura
Safety of Caplacizumab in Patients Without Documented Severe ADAMTS13 Deficiency During the HERCULES Study- #1093 - Saturday, December 7, 2019, 5:30 PM 7:30 PM (ET)
Efficacy of Caplacizumab in Patients with aTTP in the HERCULES Study According to Baseline Disease Severity#2366 - Sunday, December 8, 2019, 6:00 PM - 8:00 PM (ET)
Efficacy of Caplacizumab in Patients with aTTP in the HERCULES Study According to Initial Immunosuppression Regimen- #2365 -Sunday, December 8, 2019, 6:00 PM 8:00 PM (ET)
Narratives of Patients with Fatal Outcomes During the Phase 2 TITAN and Phase 3 HERCULES Studies - #4908 (abstract only)
Sickle Cell Disease and Beta Thalassemia
Genetic Activation of NRF2 By KEAP1 Inhibition Induces Fetal Hemoglobin Expression and Triggers Anti-Oxidant Stress Response in Erythroid Cells- #210 - Saturday, December 7, 2019, 2:00 PM 3:30 PM (ET) Oral Presentation Room W414B
Zinc Finger Nuclease-Mediated Disruption of the BCL11A Erythroid Enhancer Results in Enriched Biallelic Editing, increased Fetal Hemoglobin, and Reduced Sickling in Erythroid Cells Derived from Sickle Cell Disease Patients- #974 - Saturday, December 7, 2019, 5:30 PM 7:30 PM (ET) Joint with Sangamo
MetAP2 Inhibition Modifies Hemoglobin S (HbS) to Delay Polymerization and Improve Blood Flow in Sickle Cell Disease- #2260 - Sunday, December 8, 2019, 6:00 PM 8:00 PM (ET)
Differential Efficacy of Anti-Sickling and Anti-Inflammatory Mechanisms in a Fluorescent Intravital Microscopy Dorsal Skinfold Vaso-occlusion Model in Sickle Cell Disease Townes Mice, #2264 - Sunday, December 8, 2019, 6:00 PM 8:00 PM (ET)
Characterization of a genetically engineered HUDEP2 cell line harboring a sickle cell disease mutation as a potential research tool for preclinical Sickle Cell Disease Drug Discovery- #3559 - Monday, December 9, 2019, 6:00 PM 8:00 PM (ET)
Preliminary Results of a Phase 1/2 Clinical Study of Zinc Finger Nuclease-Mediated Editing of BCL11A in Autologous Hematopoietic Stem Cells for Transfusion-Dependent Beta Thalassemia #3544 Monday, December 9, 2019, 6:00 8:00 PM (ET) Joint with Sangamo
Identification of Novel Variants Associated with Fetal Hemoglobin Levels in Healthy Donors (the INTERVAL study) - #2243 - Sunday, December 8, 201, 6:00 PM - 8:00 PM (ET)
Rare Disease Presentations:
Gaucher Disease
Response to Oral Eliglustat in Adults with Gaucher Disease Type 1: Results from 4 Completed Clinical Trials - #4859 (abstract only)
About isatuximabIsatuximab, an investigational anti-CD38 monoclonal antibody, targets a specific epitope on the CD38 receptor and is designed to trigger multiple, mechanisms of action that are believed to directly promote programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on multiple myeloma cells and cell surface receptors, making it a potential target for antibody-based therapeutics such as isatuximab.
Isatuximab is an investigational agent and its safety and efficacy have not been evaluated by the U.S. FDA, the European Medicines Agency, or any other regulatory authority.
About SutimlimabSutimlimab is a C1s inhibitor that received breakthrough therapy designation and is currently being investigated for the treatment of CAD in Phase 3 clinical trials. A humanized, monoclonal antibody, sutimlimab is designed to target C1s, a serine protease within the C1-complex in the classical complement pathway of the immune system, which directly impacts the central mechanism of hemolysis in CAD. Similarly, the classical complement pathway has been shown to contribute to the physiopathology of immune thrombocytopenic purpura (ITP). With a unique mechanism of action and high target specificity, sutimlimab is designed to selectively inhibit disease processes by upstream blockade of the classical complement pathway while maintaining activity of the alternative and lectin complement pathways, which are important for immune surveillance and other functions.
Sutimlimab has not been approved by the FDA, EMA or any other regulatory authority for any indication and no conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.
About BIVV001BIVV001 (rFVIIIFc-VWF-XTEN) is a novel and investigational recombinant factor VIII therapy that is designed to provide high sustained factor activity and extend protection from bleeds with prophylaxis dosing of once weekly for people with hemophilia A. BIVV001 builds on the company's innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. BIVV001 was granted orphan drug designation by the Food and Drug Administration in August 2017 and the European Commission in June 2019. BIVV001 is being developed in collaboration with Sobi.
BIVV001 has not been approved by the FDA, EMA or any other regulatory authority for any indication and no conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.
About FitusiranFitusiran is potential first-in-class investigational, once-monthly, subcutaneously administered RNA interference therapeutic targeting antithrombin (AT) in development for the treatment of hemophilia A and B, with and without inhibitors. Fitusiran also has the potential to be used for rare bleeding disorders. Fitusiran is designed to lower levels of AT with the goal of promoting sufficient thrombin generation to restore hemostasis and prevent bleeding. Fitusiran utilizes Alnylam's ESC-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency and durability. The clinical significance of this technology is under investigation.
Fitusiran has not been approved by the FDA, EMA or any other regulatory authority for any indication and no conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.
About BIVV003BIVV003 is an investigational ex vivo gene-edited cell therapy for the treatment of people with sickle cell disease being developed in collaboration with Sangamo Therapeutics, Inc. BIVV003 is a non-viral cell therapy that involves gene editing of a patient's own hematopoietic stem cells (HSCs) using zinc finger nuclease (ZFN) technology to address underlying disease pathophysiology. A Phase 1/2 clinical trial to assess the safety, tolerability, and efficacy of BIVV003 in adults with sickle cell disease has been initiated. Sanofi and Sangamo collaborate on a similar second program, ST-400, an investigational ex vivo gene-edited cell therapy, for the treatment of adults with beta-thalassemia. The safety, efficacy and tolerability ST-400 is currently being evaluated in a Phase 1/2 clinical trial.
BIVV003 has not been approved by the FDA, EMA or any other regulatory authority for any indication and no conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.
About CabliviCablivi should be administered upon initiation of plasma exchange therapy, and in combination with immunosuppressive therapy, based on a diagnosis of aTTP. Cablivi is first administered as an 11 mg intravenous injection prior to plasma exchange, followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1. During the daily plasma exchange period and 30 days following daily plasma exchange, patients will take daily 11 mg subcutaneous injections. If after the initial treatment symptoms of the underlying disease are unresolved the treatment can be further extended for a maximum of 28 days. Subcutaneous injection can by administered by a patient/caregiver following proper training.
Cablivi was developed by Ablynx, which was acquired by Sanofi in 2018. Cablivi was approved in the European Union in August 2018 and in the United States in February 2019. Cablivi is part of the company's rare blood disorders franchise within Sanofi Genzyme, the specialty care global business unit of Sanofi.
CABLIVI IMPORTANT SAFETY INFORMATION
What is CABLIVI?
CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Who should not take CABLIVI?
Do not take CABLIVI if you've had an allergic reaction to caplacizumab-yhdp or to any of the ingredients in CABLIVI.
What should I tell my healthcare team before starting CABLIVI?
Tell your doctor if you have a medical condition including if you have a bleeding disorder. Tell your doctor about any medicines you take.
Talk to your doctor before scheduling any surgery, medical or dental procedure.
What are the possible side effects of CABLIVI?
CABLIVI can cause severe bleeding. In clinical studies, severe bleeding adverse reactions of nosebleed, bleeding from the gums, bleeding in the stomach or intestines, and bleeding from the uterus were each reported in 1% of subjects. Contact your doctor immediately if excessive bleeding or bruising occur.
You may have a higher risk of bleeding if you have a bleeding disorder (i.e Hemophilia) or if you take other medicines that increase your risk of bleeding such as anti-coagulants.
CABLIVI should be stopped for 7 days before surgery or any medical or dental procedure. Talk to your doctor before you stop taking CABLIVI.
The most common side effects includenosebleed, headache and bleeding gums.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.
Click here for full prescribing information.
Please visit http://www.cablivi.com.
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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New data to be presented at ASH 2019 highlight Sanofi's commitment to treat challenging blood cancers and rare blood disorders - PRNewswire
Recommendation and review posted by Bethany Smith
Continuing Medical Education on Trans Health: Addressing the HUD’s Proposed Rule (Part 2 of 2) – Pager Publications, Inc.
Homelessness is a prominent concern among LGBT+ people, particularly the transgender community. Nearly one-third of the respondents who completed the 2015 U.S. Transgender Survey reported homelessness at some point in their lives, with even higher rates (74%) among individuals whose families had rejected them. Additionally, at the time the survey data was collected, the number of respondents who were concurrently homeless (0.53%) was three times that of the general U.S. adult population (0.18% according to the Department of Housing and Urban Development). This prevalence demonstrates the pervasiveness of home insecurity in the transgender community, which is partially caused by the transphobic socioeconomic discrimination mentioned in the first part of this series.
Homelessness can create a multitude of risks that directly cause health problems, exacerbate existing illness and make conditions more difficult to treat or manage. Therefore, housing insecurity may create complicated clinical scenarios that cannot be readily resolved by our standard health care system. As stated by the National Health Care for the Homeless Council (NHCHC) in the Homelessness & Health Fact Sheet, The best, most coordinated, medical services are not very effective if the patients health is continually compromised by street and shelter conditions. Even inpatient hospitalization, or residential drug treatment and mental health care (when available), do not have lasting impacts if a client has to return to the streets upon discharge.
Transgender individuals health may be more severely impacted by homelessness because of the decreased availability of supportive public services. In Transitioning Our Shelters: A Guide to Making Homeless Shelters Safe for Transgender People, the National Gay and Lesbian Task Force and the National Coalition for the Homeless assert that transgender people have a greater need for shelter and other social services because of lack of education, discrimination, increased ejection from homes, inability to access quality health care and inability to pay for transgender-specific health services such as hormones, counseling and gender-affirming procedures. Lifelong, systemic discrimination against transgender individuals can cause them to have an increased need for institutional support while also denying them access to such assistance.
Services available to cisgender individuals are also not always accessible to transgender persons. Homeless shelters are often thought of as a step towards escaping homelessness, but shelters can be especially unsafe for this patient subset. In the 2015 U.S. Transgender Survey, 26% of respondents who were homeless in the past year avoided shelters for fear of maltreatment. Of those who did stay in a shelter, 70% experienced this identity-based mistreatment. Both staff members and residents were responsible for the discrimination. Shelter staff ejected some respondents (9%) after they became aware of the participants identity and forced even more (14%) to present as the wrong gender. Transphobia from shelter staff also prevented some individuals (4%) from being initially approved as residents. Forty-four percent of the respondents who lived at a shelter eventually left because of poor treatment or unsafe conditions.
A 2016 telephone test conducted by the Center for American Progress (CAP) and Equal Rights Center also illustrates the prevalence of discrimination from shelter staff. Only 30% of the shelters contacted by the study indicated that were willing to accommodate transgender women, with 13% stating that the resident must be placed in isolation or with men and 21% refusing shelter entirely. Instances of discrimination from shelter staff in this test and other surveys by CAP were not localized to a specific area, but were reported across the country. Rather than being a site of stability, homeless shelters are a place of targeted harassment and anxiety for transgender residents. By increasing their experiences of discrimination and hostility, shelters might contribute to transgender individuals negative health outcomes and decreased health service utilization. However, avoiding or not being able to access a shelter may also cause transgender individuals to face unsafe conditions on the streets. If providers are not aware of specific programs policies towards transgender people, they may risk recommending unaccepting housing rehabilitation or shelter programs to their homeless transgender patients.
A new proposal from the Department of Housing and Urban Development (HUD) would risk making this patient subgroup even more susceptible to discrimination when seeking shelter services. The proposal would allow for HUD-funded shelters to refuse admission based on factors such as religious beliefs. Religious freedom has frequently been cited as a tactic to avoid providing services to LGBT+ individuals, including health care services. Sasha Buchert, a senior attorney with Lambda Legal, said of the proposal, This would be absolutely devastating in the sense that it would send a message to shelter providers that they can turn away trans people with impunity. Theyre wrong. The law is the law and the federal housing Title VII [of The Civil Rights Act] prohibits discrimination based on sex and that would encompass gender identity.
However, Bucherts statement does not take into account the difficulties that rejected applicants would have in filing such discrimination claims and the current federal deliberations on whether laws prohibiting discrimination on the basis of sex apply in cases of transphobia. Allowing for refusal of shelter admission may further reduce the small number of services transgender people can and are willing to access, and sets a precedent for discrimination from shelter and governmental staff. Both results will cause homeless transgender individuals to experience more shelter-based and street-based instances of discrimination and violence. Such experiences can contribute to diminished physical and emotional wellness among this population. Additionally, homeless transgender people may avoid other organizations that they perceive to be discriminative or religiously intolerant, such as religiously-affiliated hospitals.
The HUDs proposal would also federally define an individuals sex as the sex listed in their governmental documents. This definition of sex specifically targets the transgender community by invalidating their gender. Although some states allow for a person to change the sex listed on their governmental documents, many transgender individuals are unable to update their gender marker because of legal, cost and time restraints. Additionally, altering legal documents may necessitate listing a location of residence, a catch-22 for homeless transgender individuals. This definition of sex may force transgender individuals to misgender themselves, unwillingly disclose their transgender identity to shelter staff or reside at sex-specific shelters that do not match their gender. These actions of misgendering may lead to diminished self-esteem and make transgender individuals more susceptible to discrimination, judgment and violence at shelter facilities.
In a statement on the proposal, Mara Kiesling, the executive director for the National Center for Transgender Equality, stated that, The programs impacted by this rule are life-saving for transgender people, particularly youth rejected by their families, and a lack of stable housing fuels the violence and abuse that takes the lives of many transgender people of color across the country. The press release further details that transgender people who have experienced homelessness are more likely to face physical and sexual violence than those who have not. By denying homeless transgender individuals the opportunity to escape unsafe environments, the HUDs proposal may increase homeless transgender peoples need for supportive services while causing them to be more fearful of seeking assistance. To prevent harm to patients and avoidance of care, physicians must address the impacts of proposals such as this, even though they may seem outside the realm of the medical community. Without being aware of current policies, physicians will continue to create treatment plans that are impossible for patients to follow or will inadequately address their needs.
Although changing homeless services may seem outside the realm of physician practice, the authors of Transitioning Our Shelters have previously made several recommendations on how health care practitioners could make clinical decisions that would improve transgender patients experiences in shelters. Transgender people need advocates for their continued access to hormone treatments while in shelters because of the undesirable mental and physical effects that cessation can have on their bodies. Therefore, transgender shelter residents may need protection from shelters syringe bans so that they can continue their hormonal injections. Without defending these needs, transgender individuals mental and physical health could worsen despite the best clinical visits. Physicians could provide statements asserting the medical necessity of gender-affirming medications and further work with transgender individuals in their community to dismantle the existing barriers at shelters. To truly care for vulnerable patients, physicians must be willing to partner with them to think of innovative ways to counteract cisnormative and transphobic practices.
If physicians advocate for transgender patients right to access medical services, such as hormone treatments in homeless shelters, they could also challenge the dehumanization and discrimination that these individuals face. With the societal and scientific authority granted to physicians for their title and training, they could lend validity to transgender individuals existing acts of advocacy through partnerships with transgender advocates and patients. Such efforts could help bridge the divide between health care providers and transgender individuals and improve societal acceptance of transgender people. By addressing larger political, social and economic barriers to health for oppressed patients and by partnering with them, physicians could prevent harm altogether and avoid searching for a cure to complex social problems during their brief clinical visits.
Image Credit: Trans Solidarity Rally and March 55401(CC BY-SA 2.0)bytedeytan
Writer-in-Training
University of South Carolina School of Medicine - Columbia
Lexi Dickson is a second year medical student at the University of South Carolina School of Medicine in Columbia, South Carolina class of 2022. In 2018, she graduated from the University of South Carolina Honors College with a Bachelor of Science in biochemistry and molecular biology. She enjoys trying new restaurants, dancing, and traveling in her free time. Lexi is undecided on what specialty she would like to pursue after graduating medical school, but is interested in emergency medicine.
Recommendation and review posted by Bethany Smith
Let’s Talk Cancer and Controversy – Thrive Global
Im going to start this postthe same way Ill end it reminding you that each persons cancer journey isjust that their own journey. Its unique to each individual there is noright or wrong way to get through a cancer diagnosis. Trust me on this one.
So why are we talking aboutcancer today? Because Ive been asked a lot lately about why I chose to avoidchemo and radiation. Especially working in the health care industry, I thinkpeople expected me to take a more traditional route. But instead, I opted totake a naturopathic approach WITH some traditional methods.
This is where it starts gettingheated. As soon as I say naturopathic, I start getting slammed forperpetuating myths or not admitting to the truth, or my personal favoritebeing a hippy-dippy Indian. True statement, I am a bit of a hippy dippyNative American I mean, I live in nature, I believe Mother Nature and all ofthe elements help us in the various facets of our lives and I do believe the wereturn to the earth from which we live on. But Im not sure thats what thesepeople mean when they say that.
Having two kinds of cancer is acomplete double whammy!
Before I go too far down thispath though, I want to acknowledge that this journey is mine and mine alone.And that although many of you know that when I say #effcancer it usually refersto my breast cancer, but what a lot of you dont know is that late last year Iwas told I have early stage cervical cancer. It was a shock. A hit to the gut or lower as the case may be. And Im not afraid to talk about it, though I dontexactly love having my vajay-jay be the topic of public fodder, it was more menot sharing because when I did tell those closest to me, I saw the deep way itimpacted them. Hearing me say I have ANOTHER form of cancer was like twisting aknife. There were tears, there were swear words, there were gasps, there were are you fuc$king kidding memoments. So, I opted to process this one with those closest to me and now,after having had a couple of surgeries and having changed my naturopathicapproach again, Im ready to talk about it.
Now that Im ready to talkabout it, why am I talking about it here? Because Ive been sharing my methodswith people individually for a while now and frankly, Im getting a littletired of repeating my message each time when I could just put it all here andpoint people to it. So, Im going to share a bit about the approach I took andwhy.
So, what do I mean by anaturopathic approach that combines with traditional methods? I mean that forboth my breast and cervical cancer, I opted to have masses removed. I opted tohave the damaged and cancerous tissues surgically removed from my body but notto move into chemotherapy drugs or radiation as the next step. I didnt want topotentially damage healthy tissue just to combat damaged tissue. I consultedmany an osteopath, naturopath, traditional Chinese medicine practitioners, etc.I asked a lot of questions, talked to a lot of people who had chosen theseoptions and made a plan.
That plan is always evolving,optimizing, changing based on research and what seems to work for me. I stillsee my primary care physician (who is an amazingProvidenceSt. Joseph Health doc), I see a naturopath and I see my oncologistspecialist (also amazing PSJH docs), and we all work together. Its part of whyI love my traditional clinical experts, they know its my choice, they arewilling to answer my questions and work with my non-traditional docs. Side note if your doctor wont answer your questions, you need a new doctor.
Youre probably thinking were seven paragraphs in and I dont know what you mean by naturopathicapproach to cancer. So here goes this is what my journey consists of:
B12 injections can take a littlegetting used to
Full cocoon red light therapy feelsamazing!
There you have it, thats beenmy path as Ive gone on this journey. There are also a lot of naturopathicoptions Ive considered but havent tried yet. Mostly because I havent neededthem, but if youre doing the research, certainly take the time to look atchelation, regenerative peptide treatment, halo therapy, biomagnetic therapy,hyperbaric oxygen therapy and more.
With so many options toconsider, make your journey the one you want it to be. Because, as I said atthe beginning, each persons cancer journey is their own to determine how andwhat they make it. I wish you all the best of luck as you go on your personalpath.
Excerpt from:
Let's Talk Cancer and Controversy - Thrive Global
Recommendation and review posted by Bethany Smith
Chris Willis: Diabetes and nutrition – Galesburg Register-Mail
November is National Diabetes Awareness Month; therefore, I chose to focus on the nutritional aspect of this very serious, yet manageable disease.
When you have diabetes, your body cant use the food you eat in the proper way. Normally, when you eat food, namely carbohydrates, they are digested and changed into glucose, a sugar the body uses for fuel. The glucose is carried by the bloodstream, where it waits to be picked up by insulin to be taken to individual cells of the body. The pancreas is an organ in your body that houses the cells that make the hormone insulin. Insulin helps the glucose enter the cells of your body, much like the key that opens the door to let the blood sugar out so you can have energy to work and play.
In the case of diabetes, you may not be making any insulin at all, known as Type 1 diabetes. This type is typically seen in newborns up to young adults. The only way to manage this type is through insulin injections.
Type 2 diabetes is when the individual is still able to produce insulin, but not enough to manage a normal blood glucose level, or is unable to use the insulin he/she makes, called insulin resistance. This type generally occurs in adulthood, but is becoming more common in childhood. Treatment generally includes medication management along with lifestyle changes such as increased physical activity, weight loss and diet changes.
A meal plan should be designed to meet individual needs. It should consist of regular meals, with or without snacks to help control the amount of sugar (glucose) in your blood. A diabetics medical regimen may determine dietary modifications. In either case, the basic premise all foods can fit into a plan is taught. Some exceptions might include sugar-loaded beverages.
Learning how to carb count can make it easier to manipulate a diet plan. In order to master this, it will be helpful to have the education from a diabetes care and education specialist (DCES), formally known as a certified diabetes educator, who has had the training and passed the exam for the credentials. A physician referral is needed for this education.
A helpful tool to start using when first learning to count carbs is knowing the portion size of the food you are eating just as in weight management strategies. Make use of measuring cups and spoons for increasing awareness of the amount of food and beverage to be consumed.
Making use of the food labels is also helpful. Pay attention to the serving size listed along with the total grams of carbohydrate. This will make sense once a carbohydrate spending allowance is given. For instance, an average adult male might do well with 60 to 75 grams of carb per meal, while a female would do better with 30 to 45 grams per meal. An example of a 45-gram carb meal would be equivalent to a sandwich on two slices of bread and a fresh fruit. The carbohydrate spending allowance will be assigned based on the individuals needs using age, activity, height and weight.
Carbohydrate foods include natural sugars such as lactose, found in milk and yogurts; fructose, found in fruits; and starch, found in grains, potatoes, pastas, rice, etc. Sugar is a simple carb that is more readily broken down and can spike blood sugars. Its use should be minimized as possible.
Sugar alcohols such as mannitol, xylitol, sorbitol, isomalt, erythritol, isomalt and maltitol come from plant products such as fruits and berries. The carbohydrate in these plant products is altered through a chemical process. These sugar substitutes provide somewhat fewer calories than table sugar (sucrose), mainly because they are not well absorbed and may even have a small laxative effect. Therefore, they have little to no effect on raising blood glucose levels.
Artificial sweeteners are alternatives to giving sweetness to foods without adding calories and minimal to no added carbs. They include:
1. Saccharin: SweetN Low (pink packages)
2. Aspartame: Nutrasweet/Equal (blue packages)
3. Acesulfame-K: Sunett, Sweet One
4. Sucralose: Splenda (yellow packages)
5. Stevia: Sweet Leaf (green packages). This is the only all-natural, zero-calorie sweetener derived from a plant.
It is important to note that just because a food is listed as sugar-free does not make it carbohydrate-free, as it may contain other sources of carbs. You still need to check the labels and count the carbs.
Once carb counting is understood, it is important to learn to add protein (fish, skinless poultry, beef or pork), and heart healthy fats (olive oil, nuts) to meals and snacks to help balance out blood sugars. For example, when choosing to eat an apple, it may be beneficial to pair it with some peanut butter, nuts or cheese. Proteins and fats do not generally produce a glucose load. They can also help to provide satiety over a longer time frame.
Personal food preferences should be taken into account when planning meals. Here is an example of a generalized, healthy meal plan that we all can strive for, diabetic or not. It includes the Mediterranean style.
BREAKFAST
Greek-style yogurt mixed with walnuts and berries of choice
1 whole-grain slice of toast spread with avocado or nut butter
LUNCH
Tuna Salad on whole-grain bun or in mixed Lettuce greens; add almonds and toss with balsamic vinegar and olive oil
Orange slices and tomato and feta cheese marinated in olive oil
SNACK
Grapes and goat cheese
SUPPER
Broiled fish or skinless chicken or turkey
Brown rice, quinoa or sweet potato
Tossed greens with tomatoes, olives, avocado and olive oil-based dressing
SNACK
Mixed nuts and apple slices
Note: Beverages may include teas, coffee or other non-sugar drinks.
As with any upcoming holiday, please be mindful while you enjoy the family traditions you have.
Chris Willis is a clinical dietitian/certified diabetes educator at OSF HealthCare St. Mary Medical Center in Galesburg.
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Chris Willis: Diabetes and nutrition - Galesburg Register-Mail
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I know we did the right thing – Mom and dad reverse chemical abortion, rescue their unborn baby – Pregnancy Help News
Ivette had just taken the first dose of the chemical abortion pill protocol when she began to feel the pangs of regret. Sitting in the abortion facility, she felt emotion wash over her.
I knew it was wrong, and as soon and the doctor walked out, I started crying. I asked my boyfriend, Why are we doing this? and he just hugged me, she wrote in a reflection sent to Heartbeat International several months later.
The abortion facility hadnt let Ivette see her unborn baby on the ultrasound screen, but they estimated her child to be about four weeks old. Just a day before, the couple had believed abortion was their only way forward. With an almost-two-year-old daughter at home, they didnt believe that bringing another child into the world was financially feasible.
That belief was about to be challenged in a major way.
On the drive back home from the abortion facility, the full force of Ivettes regret came rushing through her.
I started arguing with my boyfriend, asking him why he had convinced me to do it. That I didnt want to, that I hated him, she wrote. And he was just looking at me, and I was crying and crying.
Struck by her words, her boyfriend pulled the car over.
He started telling me I was right, that he was dumb for even talking me into it, that we shouldve done the right thing, she recalled.
Thats when her boyfriend decided to take action. Grabbing his phone, he began searching the internet for a way to save their unborn baby. He came across Abortion Pill Rescue, a 24/7 helpline (877-558-0333) backed by a network of 800 medical professionals offering Abortion Pill Reversal.
Otherwise known as the abortion pill or RU-486, chemical abortions typically involve two drugs: mifepristone and misoprostol. Mifepristone, the first drug, destabilizes a pregnancy by blocking progesterone, the natural hormone needed to sustain a healthy pregnancy. To finish the abortion, misoprostol induces labor, forcing a womans body to deliver the baby.
The reversal protocol, which was developed by physicians George Delgado and Matt Harrison more than a decade ago, works by giving a woman extra progesterone up to 72 hours after she takes the first chemical abortion drug.
Now operated by Heartbeat International, the Abortion Pill Rescue Network (APRN) has saved more than 900 babies to date.
Women who are facing the immediate regret of abortion call the APRN helpline every day seeking hope and options, said Christa Brown, director of Medical Impact for Heartbeat International. They dont give up the right to other choices when they seek an abortion and we are here to help.
For Brown, a womans courage to call the helpline and try to rescue her baby is nothing short of heroic.
One of APRNs main goals is to help ensure that women like Ivette have the opportunity to choose life for their children every step of the way, she said. We are so thankful for the courage and strength of our clients who choose life often under many pressures to continue the abortion. All of our 900 moms are true heroes.
Despite whatever glimmer of hope the helpline offered, Ivette was convinced it was too late for their baby.
I told (my boyfriend), Hang up. This is ridiculous. Theres nothing we can do. What is done is done, and took away his phone as we drove back home, she wrote. I felt sad. I felt mad. I hated myself. I couldnt stop thinking about my daughter I already had and what a beautiful blessing she was coming into our lives.
Tears overwhelmed Ivette for the rest of the day. She could hardly sleep that night. Early the next morning, she searched the internet once more for the Abortion Pill Rescue number.
A really nice nurse answered, Ivette wrote. I will never forget her. She started asking me questions and told me we were still in time to reverse the abortion.
The nurse connected Ivette to a local doctor who provides the Abortion Pill Reversal protocol and advised her not to take the rest of the chemical abortion regimen. The doctors office set Ivette up with an appointment immediately. Together, she and her boyfriend drove 45 minutes to the pro-life clinic.
I felt so much peace as I entered his clinic, Ivette wrote. It had a really big Virgin Mary and a little place for people to pray. I felt hope.
While waiting to be seen, she slipped into the bathroom. Her hope faltered as she saw how much she was bleeding.
I was bleeding so much, and I said to myself, Im losing the baby, she wrote.
But the doctor was still willing to fight for her and her unborn baby. He administered progesterone to her and prescribed more for her to take over the course of the next two weeks when she was to return to the clinic for a follow-up appointment.
Ivettes worries werent gone just yet. The same day she began the reversal treatment, she received a dire voicemail from the abortion facility she had visited. The staff reminded her to take the other four chemical abortion pills the facility had given her and warned that if she continued the pregnancy, her baby would be born with birth defects.
Once more, Ivette turned to the kind nurse from the Abortion Pill Rescue helpline for guidance. Using the research performed by physician George Delgado, the nurse assured her that her baby was at no greater risk of being born with a defect than any other baby.
As the days passed by, Ivette continued to bleed heavily. Nevertheless, she continued to take the progesterone, and after two weeks, she returned to the pro-life clinic.
Ivette nervously watched the screen as the doctor performed the ultrasound. Then, he gave her the news she was longing to hear.
He told me, Theres a heartbeat!!! she said. And there it was on the screen, a little flickering. We couldnt believe it. I looked over at my boyfriend as he smiled and said, We did the right thing.
Ivette continued to take progesterone for the rest of the first trimester. Then, late last year, she met the tiny baby she and her boyfriend rescued all those months ago.
I delivered my baby boy by c-section, and let me tell you, he is the cutest little guy, she wrote. I couldnt imagine my life without my daughter and my son. I love them so much and I know we did the right thing. Thank you, Abortion Pill Reversal, for this second chance.
Recommendation and review posted by Bethany Smith