Hormones are natural substances made by our glands in our body and the network of glands that make hormones is termed as endocrine systems. These hormones are carried through bloodstream and act as a messenger between one part to another part of our body. Hormone therapy is one of the major modalities of medical treatment for cancers which involves manipulation of the endocrine systems through exogenous administration of steroid hormones or drugs inhibiting or interrupting activities of specific hormones. Surgical removal of certain endocrine organs for instance oophorectomy can also be employed as a part of hormone therapy. In hormone therapy physician generally start with hormone receptor test that let caregivers to measure amount of cancer proteins or hormone receptors within a cancer tissue. By estimating the amount of hormones such as estrogen or progesterone the test either can be positive or negative. A positive test indicates growth of cancer cells with the help of hormones. In such cases physician divert the hormone therapy by blocking the interaction of hormones with the hormone receptor. Alternatively, in case of negative hormone receptor test which signifies null effect of hormones in growth and development of cancer cells other effective treatments can be rendered to cure cancer.

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A hormone therapy can be rendered either before or after a primary treatment. In case it is rendered before the primary treatment it is medically termed as neoadjuvant treatment which kills. Neoadjuvant treatments help to kill cancer cells and contribute to the effectiveness of the primary therapy. If hormone therapy is given after the primary cancer treatment, it is called adjuvant treatment. Adjuvant therapy is given to improve the chance of a cure. Now a day hormone therapy is widely used in treating breast and prostate cancer. In breast cancer the female hormone estrogen are primarily responsible for stimulating the growth and development of breast cancer cell in majority of cases. Recently in 2014, aromatase inhibitors such as Arimidex and Femara have been approved for treating breast cancers through hormone therapy. Apart from these FDA approved Zoladex Lupron can also be used in curing breast cancers through hormone therapy. In case of prostate cancer a variety of medications can be used as hormone therapy. Male hormones, such as testosterone, stimulate prostate cancer to grow. Hormone therapy is given to help stop hormone production and to block the activity of the male hormones. Some of the antiandrogens used as inhibitors of prostate cancer cell growth encompass flutamide, enzalutamide, bicalutamide, and nilutamide among others. some of the other cancers to which hormone therapy is gaining acceptance now a day include womb cancer, kidney cancer, ovarian cancer among others.

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Major drivers to global cancer hormone therapy include rising incidences of cancer across globe. Statistically according to WHO cancer accounts for 8.2 million deaths in 2012 and it is estimated that annual cancer cases is expected to rise from 14 million in 2012 to 22 million by 2022. Rising awareness among physician and patients towards alternative cancer therapy processes such as target therapy, immunotherapy or hormone therapy is likely to uplift the market in forthcoming years. Side-effects associated with hormone therapy are major restraints to growth and acceptance of therapy. Some of the common side-effects associated with hormone therapy for cancer include nausea, vaginal spotting, irregular menstrual periods, skin rashes, loss of appetite, vaginal dryness, impotence and male breast enlargement among others.

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Prominent companies operating the global cancer hormone therapy market include AstraZeneca plc, Novartis International AG, Merck & co., QuatRx Pharmaceuticals and Pfizer, Inc. among others.

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Cancer Hormone Therapy Market: Rising incidences of cancer across globe is a major driving - BioSpace

Recommendation and review posted by Bethany Smith

The leader of the free world is now fighting his own battle with a virus that's laid global siege. A concoction of some experimental treatments is helping him do it.

On Monday evening, after spending three nights undergoing treatment for COVID-19 at Walter Reed National Military Medical Center, President Donald Trump returned home to the White House.

Standing on the balcony, Trump removed his mask and gave a double thumbs up to the crowd.

Minutes later, in a produced video released via tweet, Trump claimed his victory over the virus.

"I didn't feel so good," Trump said to camera. "Two days ago I felt great, like better than I have in a long time... better than 20 years ago."

"Now I'm better -- and maybe I'm immune! I don't know. But don't let it dominate your lives. Get out there. Be careful. We have the best medicines in the world, and they're all happened, very shortly, and they're all getting approved."

Trump has been recovering under close watch from a team of physicians administering world-class care and special access to therapeutics. Monday, his personal physician, Dr. Sean Conley, told reporters Trump "has continued to improve" over the past 24 hours, having "met or exceeded all standard hospital discharge criteria."

There is not enough evidence to confirm when, or if, some level of immunity to COVID-19 occurs, and how long it might last. Experts say right now, the president is likely still contagious. The Centers for Disease Control and Prevention says COVID-19 patients should stay isolated for at least 10 days after the start of their symptoms or after receiving a positive test. Trump's doctors said Monday he "may not entirely be out of the woods yet," but they are using what they have called a "multi-pronged approach" in his treatment, which will continue as he recuperates at home.

Trump's diagnosis early Friday morning plunged a nation already in chaos into further crisis, uncertainty and fear for his well-being of urgent concern amid a pandemic that has now claimed the lives of more than 210,000 Americans.

Over the weekend, Trump assured the public he was feeling "much better" since being given a sundry mix of medication, some of it experimental, which he called "miracles coming down from God."

A car with US President Trump drives past supporters in a motorcade outside of Walter Reed Medical Center in Bethesda, Maryland on October 4, 2020.

The full picture of what treatments Trump has received thus far is still evolving, as still-outstanding questions in the public interest are met with more fulsome, forthright detail. Monday, his medical team told reporters they continue to treat him with the intravenous antiviral Remdisivir, and have continued with the steroid Dexamethasone.

Of the combination of medicines and supplements now being deployed to help him recoup, many are not yet definitively known to beat the novel coronavirus, but are thought to help mediate the virus' symptoms and severity in the body. There is, as of now, no drug "approved" by the FDA for COVID-19 treatment, though some have been given emergency authorization.

Some experts have raised questions about the uniquely robust drug regimen now being administered to the president. Dr. Lew Kaplan, president of the Society of Critical Care Medicine and a surgeon at the University of Pennsylvania, said these types of "non-standard processes" can " invite error." This exact combination of medications has not been tested together yet in large-scale studies.

NIH treatment panel guidelines member Dr. Mitchell Levy assured that there is no "miracle" drug yet available.

"If you look at our guidelines, we just don't think there's enough evidence to recommend one way or the other," Levy, chief of pulmonary critical care at Warren Alpert Medical School of Brown University, told ABC News. "So little is proven. It's like the Wild West, and he's the president of the United States, and so you feel like: 'I want to do anything I can to prevent the disease from progressing.' That often drives us to do things outside of the normal standard. And that is never a good idea. There's a standard of care for a reason. With COVID-19, part of the problem is, we're never really sure what the standard of care is."

Other experts are more optimistic

"All of these treatments shift the odds in your favor," Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, told ABC News. "None of them is a magic wand that suddenly makes you feel better," he added, explaining that Trump's treatment plan was made respecting the parameters of available science.

The president's doctors have said he is taking at least eight medicines and supplements. The timeline of Trump's illness remains murky; however, here's what we know about what the president is taking -- and when he started taking it.

Remdesivir

Before Trump was to check out of Walter Reed and head back to the White House Monday evening, his physicians told reporters they planned to administer the fourth dose of the antiviral drug Remdesivir. He has been receiving Remdesivir intravenous infusions since Friday, within 24 hours of revealing his diagnosis. Initially developed for Ebola treatment, it has solid evidence supporting its use in COVID-19 patients, according to the National Institutes of Health, and based on that promising potential, the FDA has issued emergency authorization for its use. Typically given to patients with severe infection, it works by hindering the virus' replication in the body.

Once Trump settles back at the residence, his doctors say, they've made arrangements for the fifth and final dose of his treatment course, Tuesday evening.

In this undated image from video provided by Regeneron Pharmaceuticals on Friday, Oct. 2, 2020, vials are inspected at the company's facilities in New York state, for efforts on an experimental coronavirus antibody drug. Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help the immune system eliminate it.

Regeneron monoclonal antibody "cocktail"

Trump is taking a cocktail of two synthetic, pharmaceutical versions of what occurs naturally in the body to fight off infection. A mix of monoclonal antibodies, this one made by biotech company Regeneron, is thought to be promising, though still in its experimental phase. Late last month, Regeneron published positive, yet preliminary data for its cocktail treatment showing it improved symptoms in patients without severe disease.

While it is not yet FDA-authorized, Trump has been granted access to it under "compassionate use," enabling him to get it outside of a clinical trial. A Regeneron spokesperson confirmed to ABC News that Trump's medical staff reached out to them for permission to use their monoclonal cocktail, and it was cleared with the FDA.

Dexamethasone

Trump's personal physician told reporters Monday afternoon that they continue to treat the president with the steroid Dexamethasone, in response to temporary drops in his oxygen levels.

A corticosteroid used for its anti-inflammatory effects, Dexamethasone has solid evidence supporting its use in COVID-19 patients, according to the National Institutes of Health. In severe cases it's thought steroids can fight the haywire inflammation caused by the virus; however in milder cases, one trial found "no benefit (and the possibility of harm) among patients who did not require oxygen."

When pressed by reporters Monday afternoon, Conley, Trump's personal physician admitted that the president had, in fact, been given supplemental oxygen twice since falling ill. Previously, Conley had said he was not sure if Trump had received it a second time, and would have to check with the nursing staff.

Regarding those two times Trump received supplemental oxygen, Conley said, "it wasn't required."

Schaffner told ABC News that though the press and public have not seen the president's chest X-rays or CAT scans, prescribing the steroid is "a borderline indication within the physicians' prerogative."

Whatever was on those CAT scans, Schaffner said, along with his oxygen levels, seems "undoubtedly what targeted physicians' decision to add dexamethasone," in hopes that it would moderate his immune system response's "collateral damage."

Famotidine

Famotidine, more commonly known by its brand-name Pepcid, is an FDA-approved for heartburn, not COVID-19. Some early, observational studies showed improved survival amongst hospitalized COVID-19 patients. Still, experts caution that observational studies are no substitute for high-quality, randomized trials designed to demonstrate a treatment's true effectiveness. A trial for an intravenous infusion of famotidine is still ongoing.

Zinc

This is not the first time Trump has said he is taking Zinc. In mid-May, Trump told reporters he had been taking both Zinc and Hydroxychloroquine as a "preventative" measure. On Friday, as his doctors listed off the treatments he would now receive for his infection, Zinc again appeared on the list. As an over-the-counter supplement, Zinc is subject to less regulatory oversight. Its virus-fighting properties have shown mixed results in prior studies. Schaffner described Zinc, along with Vitamin D, as "adjunctive therapies, the benefits of which are not known."

"There is some data that Zinc is helpful if you have the common cold," he said. "But not COVID."

Vitamin D

Trump's doctor announced the president is also taking a vitamin D supplement. Studies show an association between vitamin D deficiency and a greater risk of and dying from COVID-19. However, most people get enough vitamin D from their diet. At this point, studies have not demonstrated that taking a vitamin D supplement can help fend off COVID-19 related illness, although there is an ongoing, randomized trial that may offer clarity.

Melatonin

Melatonin is a naturally-occurring hormone with antioxidant, anti-inflammatory properties also helping regulate circadian rhythms. Some researchers have suggested that the supplement might help compliment other COVID-19 treatments. At this point, research showing that this supplement helps COVID-19 patients is limited, but there is at least one small, randomized study ongoing in the U.S.

Aspirin

Available over the counter, aspirin have been taken internationally as concomitant treatment for COVID-19 -- in response to the strange prevalence of clotting and pulmonary embolism doctors have seen crop up in some patients. Aspirin may also help reduce low grade fevers. Saturday, the president's medical team said he no longer had a fever, after less than a day's time. On Monday afternoon, his medical team told reporters Trump "has not been on any fever reducing medications for over 72 hours," but declined to elaborate.

For people for people who don't have increased cardiovascular risks or COVID-19, daily aspirin use is no longer recommended as a way to reduce the risk of heart attacks, because the risks are now believed to outweigh the benefits.

Before taking any medication, people should always check with their doctor, as every patient's situation is different.

This report was featured in the Monday, Oct. 5, 2020, episode of "Start Here," ABC News' daily news podcast.

"Start Here" offers a straightforward look at the day's top stories in 20 minutes. Listen for free every weekday on Apple Podcasts, Google Podcasts, Spotify, the ABC News app or wherever you get your podcasts.

ABC News' Eric Strauss and Ben Gittleson contributed to this report.

Read more from the original source:
All the president's medicine: How doctors are treating Donald Trump - ABC News

Recommendation and review posted by Bethany Smith

O'FALLON October is National Breast Cancer Awareness Month, a time to reaffirm our commitment to fighting breast cancer and to remind ourselves and others the importance of prevention and early detection.

Breast cancer can develop in women of every age, race, and ethnic group. According to the American Cancer Society, more than 200,000 women will be diagnosed with invasive breast cancer this year, and approximately 40,000 women will die. Breast cancer in men is not as common, but it does happen, affecting about 2,000 American men each year. Fortunately, the death rate for those diagnosed with breast cancer has decreased significantly due to early detection.

Breast cancer is the second leading cause of cancer death in women in America, but its also one of the most treatable when detected early, said Jacqueline Owens, MHA, BS, RDMS, director of radiology at St. Elizabeths. Each woman should take time out of her busy schedule to take care of herself and get essential screenings.

HSHS St. Elizabeths Hospital encourages women to take charge of their breast health by following these important breast cancer prevention tips:

Self-check. Starting at age 20, women should do a monthly self-breast exam. Visit http://www.nationalbreastcancer.org/breast-self-exam for more information.See your physician regularly. Women ages 20-40 should have a breast exam by a physician or nurse practitioner every three years, and annually thereafter. If you are high risk because of family or personal history, then you should see a physician every six months starting at age 25. Get a Mammogram. Mammograms should be done every one to two years for women age 40 or older and begin at age 30 if you are at high risk.Know your family history. Women who have a first-degree relative or other close relatives who have had breast cancer may be at increased risk of developing these cancers. When determining your risk due to a family history, it is important to look at the number of women and/or men in your family who have been diagnosed and the age at which they were diagnosed. Talk to your physician about your family history and discuss what you should be doing for prevention and screening.Breastfeed. Women who breast-feed their babies for at least a year in total have a reduced risk of developing breast cancer later in life.Develop healthy habits. Eat low-fat foods and lots of fruits and vegetables. Stay close to the weight your doctor says is right for you and exercise regularly. An increased physical activity, even when begun later in life, reduces overall breast-cancer risk by about 10 percent to 30 percent. Limit alcohol intake to no more than one drink a day and refrain from tobacco use.If you are diagnosed with breast cancer, your physician will likely recommend a combination of treatments depending on the type of cancer, the stage of the cancer and your overall health. Common ways of treating breast cancer include surgery, radiation therapy, chemotherapy, hormone therapy and immunotherapy.

To schedule your mammogram at any of St. Elizabeths three, convenient imaging locations, call 618-222-4639 or use our easy, online scheduling tool through MyChart (https://www.hshs.org/StElizabeths/MyChart) to make an appointment. You can also learn more about the womens health services offered at HSHS St. Elizabeths Hospital at http://www.steliz.org.

To learn more about breast cancer prevention, visit https://www.cancer.org/breastcancer.

Text @RB to 618-202-4618 to sign up for Text Alerts from RiverBender!

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Honoring National Breast Cancer Awareness Month: Tips to Take Charge of Your Breast Health - RiverBender.com

Recommendation and review posted by Bethany Smith

Breast cancer data reported during the 2020 European Society Medical Oncology (ESMO) Virtual Congress revealed major advances in the treatment paradigm. The agents included in these trials challenged that standard-of-care.

The biggest updates presented at ESMO were in the setting of hormone receptor (HR)positive, HER2-negative advanced breast cancer. There were also some reports of efficacy with agents in triple-negative breast cancer and early breast cancer.

Updated results from the use of alpelisib (Piqray) in combination fulvestrant in the phase 3 SOLAR-1 trial were presented at ESMO by Fabrice Andre, MD, PhD, director of research at Gustave Roussy in France. First, Andre provided a recap of the primary analysis data.1

We previously reported in 2019 in the New England Journal of Medicine that alpelisib improves progression-free survival from 5 to 11 months in patients with PIK3CA mutations. There was no benefit observed in patients without PIK3CA mutations, Andre told Targeted Oncology, in an interview.

At ESMO we reported a secondary endpoint, overall survival. What was observed is that there was a difference in the median overall survival of 8 months between patients who did not receive alpelisib in patients who received alpelisib, Andre added.

The addition of alpelisib specifically prolonged overall survival (OS) in patients with HR-positive, HER2-negative, PIK3CA-mutant advanced breast cancer by 7.9 months as compared with chemotherapy alone. The median OS with alpelisib/fulvestrant was 39.3 months (95% CI, 34.1-44.9) compared with 31.4 months (95% CI, 26.8-41.3) in the placebo-plus-fulvestrant arm (HR, 0.86; 95% CI, 0.64-1.15; one-sided P .0161).

Considering stratification measures in SOLAR-1, subanalyses of patients with lung and/or liver metastases, as well as patients with PIK3CA mutations in plasma circulating-tumor DNA(ctDNA) were separately assessed. The OS result favored alpelisib plus fulvestrant in patients with lung and/or liver metastases. The median OS was 37.2 months (95% CI, 28.7-43.6) with added alpelisib versus 22.8 months (95% CI, 19.0-26.8) with fulvestrant alone (HR, 0.68; 95% CI, 0.46-1.00).

Patients with PIK3CA mutations in their plasma ctDNA also fared better in terms of OS with alpelisib/fulvestrant compared with placebo/fulvestrant with a median OS of 34.4 months (95% CI, 28.7-44.9) versus 25.2 months (95% CI, 20.7-29.6), respectively. The HR for risk of death in this subgroup was 0.74 (95% CI, 0.51-1.08).

The combination of alpelisib plus fulvestrant was overall beneficial for patients with HR-positive, HER2-negative advanced breast cancer, although the OS result did not meet the prespecified OBrien-Fleming boundary. Notably, there was a progression-free survival (PFS) benefit observed with patients, which Andre determined was supported by a numeric increase in OS.

The CDK4/6 inhibitor abemaciclib (Verzenio) was administered alone or in combination with tamoxifen as treatment of patients with HR-positive, HER2-negative metastatic breast cancer in the phase 3 nextMONARCH clinical trial. It was hypothesized with this study that, unlike other CDK4/6 inhibitors, abemaciclib monotherapy at 150 mg over 200 mg could improve survival on its own.2

To validate the theory, the study included 3 arms. In arm A, patients received abemaciclib 150 mg in combination with tamoxifen 20 mg. Arm B received abemaciclib 150 mg only, and arm C received abemaciclib 200 mg plus prophylactic loperamide.

The trial did show a promising OS improvement in the combination arm, despite not being powered for this result.

We have seen a lot of data in the first- and second-line space with CDK4/6 inhibitors, with ribociclib [Kisqali], palbociclib [Ibrance], and abemaciclib. Abemaciclib is a bit different because its the only CDK4/6 inhibitor that has a single-agent approval, Erika Hamilton, MD, told Targeted Oncology in an interview.

What we saw in nextMONARCH was that the progression-free survival and overall survival was quite similar to what was previously published, a 7.9-months difference that was not statistically significant. But we did see an overall survival benefit in [the combination arm] when abemaciclib was given in combination with tamoxifen.

The OS observed with abemaciclib plus tamoxifen was 24.2 months compared with 20.8 months among patients treated with single-agent abemaciclib at 150 mg and 17.0 months among those who received abemaciclib 200 mg. The difference between the arm A and arm C was calculated with a HR of 0.62 (95% CI, 0.40-0.97; P = .0341). The HR for the difference between arm B versus arm C was 0.96 (95% CI, 0.64-1.44; P = .8321).

It was noted during Hamiltons ESMO presentation that abemaciclib/tamoxifen also improved PFS at 9.07 months compared with 7.43 months with 200-mg abemaciclib alone (HR, 0.81; 95% CI, 0.56-1.16; P = .2493). Single-agent abemaciclib 150 mg had a median PFS of 7.23 months compared with the 200-mg dose (HR, 1.06; 95% CI, 0.74-1.53; P = .7400).

The survival results from nextMONARCH were said to have confirmed the benefit of abemaciclib that was previously observed in phase 2 MONARCH-1 clinical trial of abemaciclib alone in patients with refractory HR-positive, HER2-negative metastatic breast cancer (NCT02102490).

In the randomized, open-label phase 3 MonarchE trial (NCT03155997), abemaciclib in combination with endocrine therapy improved invasive disease-free survival (iDFS) compared with endocrine therapy alone in patients with HR-positive, HER2-negative early breast cancer, demonstrating the benefit of CDK4/6 inhibitors in other settings.3

The primary end point was invasive disease-free survival [in which we] saw significantly fewer events in those patients treated with abemaciclib compared to those who had endocrine therapy alone. It resulted in a 25% reduction in the risk of recurrence with a hazard ratio of 0.747 and this was statistically significant, Stephen R. D. Johnston, MD, PhD, FRCP, professor of breast cancer medicine and consultant medical oncologist, at the Royal Marsden, NHS Foundation Trust, told Targeted Oncology in an interview.

The HR Johnston mentioned was based on 136 iDFS events in the abemaciclib combination arm versus 187 in the endocrine therapy-only arm (95% CI, 0.598-0.932; 2-sided P = .096). At 2 years, the iDFS rate was 92.2% in the abemaciclib/endocrine therapy group versus 88.7% in the endocrine therapy-only group for an absolute difference of 3.5 percentage points. The benefit was carried over into subgroups populations, most notably among patients who had received prior neoadjuvant chemotherapy and those who were premenopausal.

A key secondary end point in this study was distant relapse-free survival (RFS), which did not include patients with local recurrence or second primary cancers. The data observed in this analysis were consistent with the primary end point showing 106 events in the abemaciclib combination arm versus 152 in the endocrine therapy arm (HR, 0.717; 95% CI, 0.559-0.920; 2-sided P = .0085). This resulted in a 28.3% reduction in the risk of distant recurrence. The 2-year distant RFS rate was 93.6% with abemaciclib/endocrine therapy versus 90.3% with endocrine therapy alone for an absolute difference of 3.3 percentage points.

The results overall imply that the addition of abemaciclib to the standard treatment of HR-positive, HER2-negative early breast cancer can prevent recurrence in these patients.

The anticipated primary analysis results from the phase 3 ASCENT trial of sacituzumab govitecan (Trodelvy) in patients with metastatic triple-negative breast cancer (NCT02574455) were presented during ESMO by Aditya Bardia, MD, MPH, medical oncologist at Massachusetts General Hospital, and assistant professor of medicine at Harvard Medical School. The results showed a significant improvement with sacituzumab govitecan over standard single-agent chemotherapy across all primary and secondary end points explored in the study.4

The first results from the ASCENT trial were presented at ESMO 2020. The primary and point of the study was progression-free survival and the study met its primary end point, Bardia told Targeted Oncology in an interview.

Overall the study was positive. Patients who received sacituzumab govitecan had a 59% lower risk of disease progression as compared with those who received standard therapy, Bardia added.

First, the median PFS achieved with sacituzumab govitecan was 5.6 months (95% CI, 4.3-6.3) versus only 1.7 months (95% CI, 1.5-2.6) with treatment of physicians choice (HR, 0.41; 95% CI, 0.32-0.52; P <.0001) per blinded independent central review. The PFS benefit was consistent across the subgroup populations explored in the study.

The OS analysis also demonstrated favor for the sacituzumab govitecan arm, which had a median OS of 12.1 months (95% CI, 10.7-14.0) versus 6.7 months (95% CI, 5.8-7.7) in the physicians choice arm (HR, 0.48; 95% CI, 0.38-0.59; P <.0001).

Finally, treatment with sacituzumab govitecan improved response from baseline in the ASCENT trial. The objective response rate (ORR) was 35% in the sacituzumab govitecan arm, which included complete responses (CRs) in 10 patients and partial responses (PRs) in 72 patients. In comparison, the physicians choice arm had an ORR of only 5% with 2 CRs and 9 PRs. Response were also more durable in the patients who received sacituzumab govitecan with a median duration of response of 6.3 months (95% CI, 5.5-9.0) versus 3.6 months (95% CI, 2.8-not evaluable) with physicians choice of therapy. The P value was .057.

Based on the primary ASCENT findings, Bardia et al concluded that the benefit of sacituzumab govitecan as treatment of metastatic triple-negative breast cancer is confirmed and should be considered a new standard-of-care treatment in this patient population.

Patients with HR-positive, HER2-negative advanced breast cancer were given treatment with ribociclib in both the MONALEESA-3 (NCT02422615) and MONALEESA-7 (NCT02278120) clinical trials. Among these patients, a subgroup had developed resistance to prior endocrine therapy.5

In MONALEESA-3 explored treatment with ribociclib in combination with fulvestrant in men and postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who have received no or only one line of prior endocrine treatment. MONALEESA-7 studied ribociclib compared with placebo plus tamoxifen in premenopausal women with HR positive, HER2 negative advanced breast cancer.

Pooled findings for outcomes for this subgroup from both studies were presented during ESMO by Sara Hurvitz, MD, a medical oncologist at the Ronald Reagan UCLA Medical Center, at UCLA Health - Santa Monica Medical Center.5The combined results showed a more than doubling of PFS with the addition of ribociclib to endocrine therapy.

What we showed in this exploratory analysis was that ribociclib was associated with 6-month improvement in overall survival compared with endocrine therapy alone. This underscores the activity of ribociclib in patients whose disease can be considered endocrine therapy-resistant, Hurvitz told Targeted Oncology, in an interview.

In MONALEESA-3, the 6-month PFS rate observed was 67% with ribociclib/endocrine therapy compared with 46% with endocrine therapy alone. In MONALEESA-7, treatment with ribociclib plus endocrine therapy led to a 74% 6-month PFS rate compared with 46% in the endocrine therapyonly arm.

The Kaplan-Meier curves for PFS in MONALEESA-3 showed that the median PFS favored the ribociclib combination over endocrine therapy alone at 13.4 months versus 5.7 months, respectively (HR, 0.621; 95% CI, 0.367-1.049). The benefit was also observed in MONALEESA-7 at 14.5 months versus 5.6 months, respectively (HR, 0.562; 95% CI, 0.342-0.922).

The median OS observed with ribociclib/endocrine therapy in the MONALEESA-3 study was 37.5 months compared with 31.7 months in the endocrine therapyalone arm (HR, 0.697; 95% CI, 0.365-1.330). In MONALEESA-7, the median OS was not yet reached in the ribociclib plus endocrine therapy arm versus 32.7 months with endocrine therapy alone (HR, 0.588; 95% CI, 0.304-1.136).

According to Hurvitz et al, these poster data demonstrate the consistent efficacy of ribociclib in patients with early breast cancer and endocrine therapy resistance.

References:

1. Andre F, Ciruelos EM, Juric D, et al. Overall Survival (OS) Results From SOLAR-1, a Phase 3 Study of Alpelisib (ALP) + Fulvestrant (FUL) for Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2) Advanced Breast Cancer (ABC). Presented at: 2020 ESMO Congress; September 19-21, 2020; Virtual. Abstract LBA18.

2. Hamilton EP, Cortes J, Ozyikan O, et al. nextMONARCH: Final overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with HR+, HER2- metastatic breast cancer. Presented at: 2020 ESMO Congress; September 19-21, 2020; Virtual. Abstract 2730.

3. Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib in high risk early breast cancer. Presented at: 2020 ESMO Congress; September 19-21, 2020; Virtual. Abstract LBA5_PR.

4. Bardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase 3 study of sacituzumab govitecan (SG) vs treatment of physicians choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Presented at: 2020 ESMO Congress; September 19-21, 2020; Virtual. Abstract LBA17.

5. Hurvitz SA, Lee SS, Jerusalem G, et al. Ribociclib (RIB) in patients (pts) with HR+/HER2_ advanced breast cancer (ABC) and resistance to prior endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at: 2020 ESMO Congress; September 19-21, 2020; Virtual. Abstract 329P.

See the rest here:
Leading Research From ESMO 2020 Further the Potential of Targeted Agents in Breast Cancer - Targeted Oncology

Recommendation and review posted by Bethany Smith

Since his coronavirus diagnosis last week, President Trump has received a variety of cutting-edge treatments, including an experimental polyclonal antibody infusion administered at the White House last Friday.

But the president, who returned to the White House on Monday after being treated at Walter Reed National Military Medical Center and reported no symptoms Tuesday, is also taking a cocktail of seemingly routine over-the-counter supplements and medications.

A recent memorandum from Trump physician Sean Conley noted that the President has been taking zinc, vitamin D, famotidine, melatonin and a daily aspirin.

As the COVID-19 pandemic rages on, with 210,000 deaths in the US and 1.04 million worldwide, can Trumps drugstore-available meds aid others in the treatment of COVID-19?

Thats still unclear, according to Dr. Bruce Farber, the chief of infectious diseases at Northwell Healths North Shore University Hospital and Long Island Jewish Medical Center.

Theres no evidence that any over-the-counter medication is active in treating or preventing COVID, Farber told The Post, adding that patients should always contact their doctors before taking any new supplements.

I think this [regimen] is somewhat unique to [Trump], Farber added.

Heres what we know so far about these supplements and how they might help treat the potentially deadly bug.

If theres one pill that stands out to Farber, its aspirin. The painkiller and blood thinner has long been part of treatment plans for those with histories of heart attacks or strokes.

Coronavirus dramatically increases the risk of spontaneous blood clots, said Farber. Thats part of COVIDs MO.

People with COVID who are sick should be on some [anti-clotting] medication, and that could be aspirin, he added.

A COVID-related aspirin trial at Xijing Hospital in China earlier this year hypothesized that early use of aspirin would reduce the incidence of severe and critical patients; however, that studys results have not yet been posted.

Famotidine, more commonly known as the over-the-counter heartburn medication Pepcid, has also been the subject of recent research.

According to a September hospital study from Connecticuts Hartford HealthCare, COVID patients who took famotidine were 45 percent less likely to die in the hospital, as well as 48 percent less likely to require a ventilator to breathe.

Current thoughts are that it may lessen the hyperimmune inflammatory response, said cardiologist Dr. Raymond McKay, the studys primary investigator, who added that the results ought to be considered preliminary and that the specific reasons for these positive outcomes were still theoretical.

Zinc, an over-the-counter mineral, is known to regulate the immune system and metabolism.

According to preliminary research from doctors working in a Barcelona hospital, patients with lower zinc levels were more likely to die from the coronavirus.

Older people and others more susceptible to COVID, such as those with a heart condition or diabetes, may also have lower zinc levels due to diet or lower absorption levels, according to a recent Wall Street Journal column,Trump Takes Zinc. Maybe You Should Too.

But Farber warns that there is too much of a good thing.

It can cause toxicity, he said. Symptoms of too much zinc can include nausea and vomiting, as well as flu-like symptoms of fever, chills or fatigue.

Zinc is not totally benign particularly if taken in large quantities for long periods of time, he added.

A recent study from the University of Chicago Medicine found a link between vitamin D deficiency and testing positive for COVID-19.

Vitamin D is important to the function of the immune system and vitamin D supplements have previously been shown to lower the risk of viral respiratory tract infections, said David Meltzer, lead author of the study.

Last month, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recommended vitamin D supplements, which he himself takes, noting that it has an impact on your susceptibility to infection.

The hormone melatonin, known to regulate sleep and produced by the brains pineal gland, can also be taken as an oral supplement.

Its usually used for sleep and sleep health, said Farber.

Additionally, the hormone has anti-inflammatory and antioxidant qualities.

Researchers at the State University of New York at Buffalo recently began a yearlong trial to determine whether melatonin can reduce the severity and halt the progression of COVID-19 when taken while symptoms are mild.

Excerpt from:
Inside Trump's supplement regimen and what experts say you can try too - New York Post

Recommendation and review posted by Bethany Smith

The flu shot is the best defense that we have to protect ourselves and others from getting sick with the influenza virus. Every year, new flu shots are developed that will protect against multiple strains of the flu. The CDC recommends that everybody over the age of 6 months old get the flu shot, with only a few rare exceptions.

Luckily, allergic reactions to the flu shot are extremely uncommon, leaving little reason for us to avoid getting the flu shot, unless your doctor specifically advises against it for you. For example, if you have an egg allergy, you might need to take certain precautions and discuss the shot with your doctor.

However, a preservative allergy is even rarer, and should not deter you from getting the flu shot, says Ryan Steele, DO, board-certified allergist-immunologist and internist at Yale Medicine.

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If you experience these symptoms, contact a healthcare provider immediately.

You should get the vaccine under the careful supervision of a healthcare provider in a medical setting if you:

You should only avoid the flu vaccine altogether if you have previously had a severe reaction to the flu shot itself.

It is a myth that Guillain-Barr syndrome (GBS) is a common reaction to the flu shot. In reality, there are only one to two cases of GBS per million flu shots administered.

GBS causes your immune system to attack nerves in your own body, resulting in symptoms like tingling or numbness that start in the lower body and escalate. This has the potential to result in paralysis, but most people can recover from GBS and live life normally.

The benefits of getting the flu shot greatly outweigh the risks. If you don't get a flu shot, your chances of becoming seriously ill from the flu are much higher than your chances of having an allergic reaction to the vaccination.

If you have personal concerns about the flu shot and any allergies, consult your doctor.

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Can you have an allergic reaction to the flu shot? It's very rare, but those with egg allergies may be at risk - Business Insider India

Recommendation and review posted by Bethany Smith

NEW YORK (PRWEB) October 08, 2020

With the health of every American being a consistent topic of conversation, and rightfully so, it has become more important than ever for individuals to be equipped with the knowledge necessary to protect themselves and their loved ones from everyday diseases and ailments. In an effort to provide the resources and information that will create informed citizens who are taking control of their health, Dr. Michelle Sands, licensed Naturopathic Physician (ND) and Co-Founder of GLOW Natural Wellness will launch Natural Medicine at Home, the free online series that focuses on making health building tools, foundational skills, and healthy lifestyle protocols accessible and affordable for all people. The virtual event goes live October 18, 2020 until October 18, 2020 but participants can take advantage of early admission now and be granted access to several of the talks, the meal plan and a host of health building resources.

As the author of the internationally best-selling book, "Hormone Harmony Over 35: A New, Natural, Whole-Body Approach to Limitless Female Health, Dr. Sands is excited to utilizing her expertise in womens and metabolic health, autoimmunity conditions and genetics to help those in need. These natural medicine techniques will help both women and men that are looking to learn affordable accessible at home health building tools and techniques to help them combat chronic disease, fortify their immune health and live healthier. Each day of the seven day long immersive event will provide the platform for Dr. Sands to teach participants how to use natural medicine safely and effectively in the privacy of their own homes, with the purpose of overcoming the various medical conditions that they may be enduring or subjective to. Virtual attendees will be treated to a well-defined daily schedule that is personally curated by Dr. Sands herself and will include:

"Naturopathic Physician on a mission to help Americans get healthy, right at home, says Dr. Sands. In the midst of the COVID pandemic, we are seeing those with chronic health conditions being at an inherent higher risk for illness, so it was an important mission of mine to bring together the top health and wellness experts in the world to teach Americans how to build health in a accessible and affordable way, right at home; while being free and online.

The Natural Medicine at Home program is the first step for those that are ready to take their health into their own hands and make the life changes necessary for a long and healthy life.

For additional information and to view the video trailer, list of topics, and international panel of experts please visit:

Registration

ABOUT DR. MICHELLE SANDSDr. Michelle Sands is a licensed Naturopathic Physician (ND), Co-Founder of GLOW Natural Wellness and author of the #1 Internationally best-selling book, "Hormone Harmony Over 35: A New, Natural, Whole-Body Approach to Limitless Female Health". She is a highly sought-after Female Hormone and Epigenetics Expert specializing in womens health, holistic fertility treatments and autoimmune conditions. Dr. Michelle, her book and resulting programs, have been featured on various platforms including ABC, CBS, Outside Magazine, The Boston Herald, NBC, Fox News, and USA Today to name a select few. Her groundbreaking program, "DNA Made Simple" takes away the confusion around genetics and epigenetics and gives people a personal, scientifically supported instruction manual for optimal health. She uses data driven science, holistic lifestyle medicine, natural supplementation, epigenetic coaching, and eastern philosophies to pinpoint the source of various chronic conditions and as a result helps patients restore their overall health and increase vital energy. Dr. Michelle is also a Board-Certified Holistic Nutritionist, Certified Personal Trainer and award-winning endurance athlete.

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GLOW Natural Wellness Creates Free Online Resource To Promote Healing At Home And Managing Chronic Disease During Pandemic - PR Web

Recommendation and review posted by Bethany Smith

Nadia Smetana

Lansford

This letter is in response to the letter from Elizabeth Larson published in the Sept. 26-27 issue of the MDN, Abortion Reversal not medically sound.

I am happy for the chance to clarify some things that were brought up in the letter. First of all, lets talk about terms. The letter used the term abortion reversal. The fundraiser held by Dakota Hope featured a woman who had experienced abortion pill reversal.

Surgical abortions are completed within minutes and of course, are not reversible. A medical abortion is a 2-step process. The first abortion pill (mifepristone or RU-486) is given at the abortion clinic. It causes an abortion by blocking progesterone receptors. Progesterone is a necessary hormone that nurtures and supports a pregnancy.

The second abortion pill (misoprostol or Cytotec) is taken at home and its purpose is to cause the uterus to contract and expel the baby.

Some women regret the abortion soon after taking the first pill. For these women there is a possibility for a second chance to save the pregnancy. Abortion Pill Reversal is a cutting-edge application of a time-tested, FDA approved treatment used safely for decades to prevent miscarriage and preterm birth. It involves an off-label prescription of progesterone to counteract the effects of the first abortion pill. Time is of the essence. The goal is to start the progesterone within 24 hours of taking the first abortion pill, but there have been many successful reversals when treatment was started within 72 hours.

A woman who wants to continue her pregnancy should not take the second abortion pill. She should also connect to a local prescribing physician for abortion pill reversal and a pregnancy help center by calling the 24/7 helpline at 1-877-558-0333 or go to the APR website, abortionpillreversal.com

According to the APR website, more than 1000 women have successfully reversed their pill abortions since the program began and many of their stories can be found on the above referenced website. Everyone is invited to listen to the powerful story of Rebekah Hagan who spoke at the Dakota Hope Fundraising Banquet. Listen free for a limited time until Oct. 21 on the Dakota Hope Clinic website event page.

As to the question of whether this is a safe and effective medical procedure, there is good evidence that it is. I would refer anyone to the resources I will post on the Friends of Dakota Hope FB page and on the Dakota Hope Clinic website under the Partner With Us tab.

After spending 16 years as a research nurse, I know that headlines on research articles can be misleading and you must take a second look at details. This is true of the 2019 study Larson referred to in her letter that purported to show that the abortion pill reversal procedure was not credible and could be harmful to patients. That study actually pointed to the riskiness of the abortion pill itself because the two patients that needed treatment for severe bleeding had received placebo, not progesterone, after taking the first abortion pill.

Another criticism leveled at abortion pill reversal proponents is that women who do not take the second abortion pill may retain the pregnancy anyway. The literature indicates that up to 25% of women who only take the first abortion pill will stay pregnant. The latest published study shows that the percentage of women who stayed pregnant when progesterone was added was 68%, a significant increase.

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Abortion pill reversal is medically sound | News, Sports, Jobs - Minot Daily News

Recommendation and review posted by Bethany Smith

As COVID-19 continues to sweep across the globe, people with thyroid disease are searching for answers.

"Does my thyroid condition put me at higher risk for infection?""What about complications?""Is it safe to continue taking my thyroid medication?"

These are common questions that endocrinologists face every day.

As of September 2020, there have been 56,236 articles on COVID-19 published in the medical literature, but only a handful address the relationship between thyroiditis and COVID-19. Because the evidence remains extremely limited, we aim to summarize the available data and offer clinical guidance to practicing endocrinologists and other clinicians.

We know that SARS-CoV-2 enters target cells by binding to angiotensin-converting enzyme 2 (ACE2). Because of the high relative expression of ACE2 on thyroid cells compared with lung cells, one hypothesis for thyroid involvement is that ACE2 in thyroid tissue might be a receptor for SARS-CoV-2 invasion.

Case reports, case series, and retrospective studies describing the association of COVID-19 and thyroiditis have reported subacute thyroiditis/de Quervain thyroiditis manifesting as subclinical hyperthyroidism or overt hyperthyroidism, often with high circulating concentrations of IL-6. Both typical (painful) and atypical (not painful) clinical presentations have been described.

Thyroid dysfunction in subacute thyroiditis usually follows a triphasic course (ie, thyrotoxicosis first, followed by hypothyroidism, and then, finally, euthyroidism) that lasts about 3 months. Symptomatic thyrotoxicosis occurs in the majority of patients, but clinical hypothyroidism is uncommon. Because viral infections such as mumps, influenza, adenovirus, coxsackie, and Epstein-Barr and cytomegalovirus viruses are known environmental triggers for subacute thyroiditis, from a biological standpoint it is not surprising that one of the manifestations of COVID-19 could be an episode of thyroiditis.

In a recent study, about 20% of hospitalized patients with COVID-19 and no previous thyroid disease were found to have elevated serum free T4 concentrations in association with decreased (but not suppressed) serum TSH concentrations and a negative antibody panel that included TSH receptor, antithyroglobulin, and TPO antibodies.

The administration of heparin, which can displace T4 from binding proteins, could play a role in these observations. However, these findings are more consistent with a diagnosis of mild hyperthyroidism possibly due to thyroid inflammation and related destructive thyroiditis due to systemic immune activation. As such, management of these patients should focus on controlling adrenergic symptoms rather than initiating antithyroid drugs.

Similarly, another study found that a substantial portion (15%) of patients with COVID-19 requiring ICU care had low TSH concentrations. However, the mean serum free T4 concentrations were not significantly different between ICU patients with and without COVID-19. The biochemical abnormalities and clinical presentation were not typical of either subacute thyroiditis or nonthyroidal illness, also known as euthyroid sick syndrome.

Multiple mechanisms may contribute to the development of euthyroid sick syndrome in the critical care setting, including alterations in TSH secretion, peripheral 5'-deiodination of T4 to T3, thyroid hormone binding to plasma proteins, transport of thyroid hormone in peripheral tissues, and thyroid hormone receptor activity. Currently available data do not support a clear benefit of treatment with thyroid hormones in euthyroid sick syndrome; ongoing clinical trials are focusing on new management strategies to explore whether restoration of normal serum thyroid hormone concentrations improves patient prognosis and clinical outcomes.

Further studies are needed to determine whether it is appropriate to increase thyroid function testing in critically ill patients with COVID-19. While awaiting these data, clinical judgement is required; symptoms of hypothyroidism or thyrotoxicosis in patients with COVID-19 should prompt thyroid function testing.

There is no evidence to date that patients with existing autoimmune thyroid disease are more susceptible to contracting viral illnesses, including infection with SARS-CoV-2, or that they are at higher risk of developing more severe COVID-19 disease. There is also no evidence to suggest increased risk for COVID-19 in poorly controlled thyroid disease, but patients with uncontrolled thyroid dysfunction (especially hyperthyroidism) may be at higher risk for complications of overt thyrotoxicosis and thyroid storm triggered by infection. Hence, patients should continue their antithyroid medications to decrease this risk.

We must educate patients about the potential complications of severe neutropenia, the signs and symptoms of agranulocytosis that may occur with antithyroid medications, and the need for urgent medical evaluation. Because symptoms of neutropenia (sore throat, mouth ulceration, fever, and flu-like illness) may overlap with symptoms of COVID-19 (fever, new continuous cough, and flu-like illness), clinical differentiation can be challenging. The best suggested approach is to stop the medication and obtain a complete blood panel to evaluate for neutrophil count. Test for COVID-19 if indicated, as lymphopenia and thrombocytopenia are seen in COVID-19 and are less likely to be related to antithyroid drugs.

After symptom resolution, antithyroid drugs can be resumed at a lower dose, or an alternative drug may be considered. If symptoms recur after reinitiation of the drug, alternative treatments for hyperthyroidism, such as radioactive iodine ablation or surgery, should be considered.

There are no suggested changes for the diagnosis and treatment of hypothyroidism during the COVID-19 pandemic. Advise patients to continue the same form and dosage of thyroid hormone replacement therapy. Thyroid function testing with TSH and FT4 levels is indicated if a patient reports significant change in hypothyroidism-related symptoms, such as worsening fatigue or weight changes, in order to adjust medication if needed. For pregnant patients, the dose of levothyroxine should be titrated to achieve the usual trimester-specific TSH targets.

In conclusion, there are no data available to suggest that patients with preexisting thyroid conditions are at higher risk for COVID-19 or its complications. Advise patients to continue their current treatment for their underlying thyroid condition but to be vigilant about reporting new symptoms. In patients severely affected by COVID-19, changes in thyroid function may be transient and related to thyroiditis or euthyroid sick syndrome, but specific thyroid-related damage and sequelae may also occur, requiring further investigation.

Physician and patient resources on COVID-19 and the thyroid are available on the American Thyroid Association website.

Spyridoula Maraka, MD, MS, is an assistant professor of medicine at the University of Arkansas for Medical Sciences (UAMS), program director of the UAMS Endocrinology fellowship program, and staff physician at the Central Arkansas Veterans Healthcare System. She has published more than 50 articles in high-impact journals, has received multiple awards and invitations to present at national and international conferences, and serves on committees of several professional organizations.

Soumya Thumma, MD, is a senior UAMS clinicalfellow in endocrinology with clinical practice interest in thyroidology. She has worked on promoting patient education and serves on national committees of two professional organizations.

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Is Thyroid Disease Worsened by COVID? - Medscape

Recommendation and review posted by Bethany Smith

Sevar Yaldo gets outdoors to relief the stress of an exam. Image: Lillian Young.

By Capital News Service

Fresh from what was conceivably the most important exam of his life, aspiring physician Sevar Yaldo sat on a Bailey Park bench for some fresh air in East Lansing.

Having spent the majority of the pandemic indoors preparing for the Medical College Admission Test, Yaldo understands and literally studied the psychological importance of getting outdoors during quarantine.

The slightest bit of fresh air can go such a long way in improving his thoughts, relationships and self-esteem, Yaldo said. Whenever I have a chance to not be inside, I will be outside, whether Im walking or running.

We often hear about how crucial it is to eat our greens. But rarely do we talk about the importance of seeing green.

Relationships with nature have diminished in an increasingly artificial world. Depression and obesity are reaching unprecedented levels.

While there are a host of treatments including medication and therapy regimens mitigating such problems may be simpler.

Anne Bretton enjoys birdwatching at Harris Nature Center in Okemos: Image: Yue Jiang.

I encourage patients with all kinds of mental health conditions be it anxiety, depression, or whatever else to get outside. Ill suggest that they walk to my office rather than driving there, said Okemos psychologist Pamella Montgomery. By the time they arrive, they always report feeling significantly better.

Montgomery has long advocated spending time outdoors.

I worked and went to graduate school full time with a 30-hour-a week internship on the side, but I still managed to run outdoors. To this day, regardless of the weather, I run outside, Montgomery said. Being outdoors and in nature is crucial to our being. Were creatures that need to interact with nature.

Psychologically, she said, Going outside gets you out of your indoor rut. It makes you stop and think about things, which you dont do sitting in front of the TV or computer.

Paul Smith of Ann Arbor drove about 1 hours to go rock-climbing at Oak Park in Grand Ledge.

This is a sport you cant really do by yourself, which I know is very insane during our COVID times, said Smith, who was with a group of people at the Ledges.

Since the start of the pandemic, Smith said hes spent less time outside. With winter coming, hes trying to get outside more.

In addition to it being physically healthy, being outdoors has a good mental impact, he said. If youre just inside all the time, I definitely find it causes a lot of drain and wear on your emotions.

Kobe is out for a morning walk in Westland. Image: Kalah Harris.

In the age of COVID-19, getting fresh air takes on new meaning.

Those fortunate enough to be near parks and trails can safely socially distance.

When Craig Dennis needs to kill time, he hits a nature trail in East Lansings Harrison Meadows Park. It gave me a purpose to go out and exercise and feel good, he said.

Outdoor activities are bustling as people have taken to hiking, walking dogs, biking and running because indoor activities remain limited. Dennis said hes seen coronavirus-wary older neighbors get outside more.

Speaking of dogs, one chilly morning in Westland, Kobe, with tongue hanging low was out for a walk with owner Jacquis Smith.

I shortened the time of how much time I spend outside. Ive noticed people arent wearing their mask when they are walking their dogs, but I always have mine on, Smith said,

Michigan State University education professor David Stroupe walks a trail alongside the Red Cedar River on campus.

I try to go in the woods and hear the birds, Stroupe said.

Michigan State professor David Stroupe hikes near the Red Cedar River. Image: Chioma Lewis

Stroupe was already going on regular walks before COVID 19 but has noticed more animals since the pandemic began. I think theyre more bold.

He doesnt bring technology. Being unplugged makes the walk more enjoyable. Since were on computers a lot now, I try and leave my phone at home, he said.

Green, leafy environments can boost a persons mood, speed up brain activity and improve overall health, according to research from the Department of Psychology at Ottawas Carleton University.

And like an all-natural ventilation system, trees and plants encountered on nature walks produce oxygen and scrub carbon dioxide from the atmosphere.

More sunshine helps. Direct sunlight isnt enough to wipe out COVID-19, the Centers for Disease Control and Prevention says, but can help produce vitamin D to gear up the immune system to fight infectious disease.

Sunlight also causes the brain to produce the hormone serotonin, which can heighten happiness.

Lansing resident Driscilla Tettey has been spending more time outdoors. Image: Audrey Porter.

On a rainy recent evening, the weather and COVID-19 didnt stop the daily busy world, especially not for Lansing resident Driscilla Tettey, whod been running errands all day.

Ive been spending more time outside now during the pandemicbecause we were social distancing and in isolation. We had to be indoors all the time, and that can take a toll on your mental health, so definitely spending more time outside helped boost my mental health and my overall well-being, Tettey said.

Anne Breton, who has been coming to the Harris Nature Center in Okemos for more than 20 years, said its been a gift to have parks in Meridian Township during this COVID-19 era.

We can walk with friends at a social distance,she said after finishing a birdwatching trip in the park.

Shes seen an uptick in the number of people of all ages using the park and said she hopes some who hadnt been enjoying the outdoors will make that a part of their lives, even after they can again go to movies.

Mckenzie Dickens takes a break from walking around the Michigan State Botanical Gardens. Image: Anne Hooper.

Mckenzie Dickens walks barefoot through rows of plants in the MSU Botanical Gardens. Sitting on the grass, crossing his legs and tucking his dreadlocks into a bandana, he said time outdoors is precious, especially in the face of COVID-19.

Theres a point when watching Netflix gets tiresome.Thankfully, though, Gov. (Gretchen) Whitmer kept state parks open so people can visit them, Dickens said of Michigans early lockdown.

For all the harm this pandemic has caused, maybe it has a silver lining. Maybe it can teach everyone how to be outside again, he said.

And its not only people in Michigan who see a silver lining.

Before the pandemic, getting outdoors wasnt easy for Bernard Crawford, an advertising student at Florida Atlantic University. With more time on his hands, being outside is the new highlight of his day.

Bernard Crawford takes a stroll in Boca Raton, Florida. Image: Lea Mitchell.

On an afternoon stroll in the 90-degree weather along Boca Raton streets, Crawford said hes felt a greater sense of connection with nature and is outdoors much of the day.

Being a full-time student, I never had the chance to get out and enjoy Gods beautiful creation. Im upset I was always inside playing video games before, he said.

This story was reported and written by Kathleen Fitch, Kalah Harris, Anne Hooper, Yue Jiang, Chioma Lewis, Lea Mitchell, Claire Moore, Audrey Porter and Lillian Young, and edited by Jiang and Lewis.

Excerpt from:
Engaging with nature and just getting outside help in the age of COVID-19 - Great Lakes Echo

Recommendation and review posted by Bethany Smith

Chantix, the brand name version of a drug called varenicline, is a nicotine-free prescription pill used to help people quit smoking gradually. Unlike nicotine replacement therapies, varenicline blocks the brain from getting pleasure due to nicotine.

Smoking is the leading cause of preventable death worldwide. This is likely because it's so difficult to quit, thanks to how nicotine affects the brain.

When you smoke, nicotine attaches to receptors located in the brain's reward center. This causes those receptors to release dopamine, a hormone that elicits feelings of pleasure. Once that dopamine rush wears off, you begin to crave nicotine, says Panagis Galiatsatos, MD, the director of the Tobacco Treatment Clinic at Johns Hopkins Medicine.

Chantix helps break this nicotine addiction in two ways:

When smoking becomes an addiction, your brain associates certain smells, locations, or emotions with the action. This makes you want to smoke when you're in certain situations, even if your brain isn't in need of a dopamine rush, says Galiatsatos.

If you smoke on Chantix, not only will it be unsatisfying, but it will also break the association between specific circumstances and the need to smoke.

"If you try to smoke [while on Chantix], it won't be successful," says Galiatsatos. "Varenicline also keeps [higher] dopamine [levels] in the brain, satisfying pleasure sensors without nicotine, and cuts cravings."

Chantix is available by prescription only and is usually prescribed for 12 weeks. It's important to speak with your healthcare provider to determine the right dosage and plan for you.

There are three proven ways you can use Chantix to quit smoking:

How long quitting takes will depend largely, but not solely, on your smoking habit. "Some patients can quit immediately but others need to be on it for longer than 12 weeks. Guidelines are fine but they are not rules, you have to adapt treatment to the patient," Galiatsatos says.

In the United Kingdom, one in four people who quit smoking were using Chantix.

A 2020 report found that experts specializing in tobacco addiction recommended that those who wish to quit smoking take varenicline over all other treatment options. The experts also recommended pairing Chantix with a nicotine patch.

A 2016 review also found that varenicline is "the most effective single-use agent for treating tobacco addiction." Two large trial studies compared smokers who took either varenicline, bupropion, or a placebo for 12 weeks. It found that 44% of those in the varenicline group had successfully quit smoking four weeks after they completed their 12-week dose, compared to 30% in the bupropion group and 18% in the placebo.

The study also found that the efficacy of varenicline is improved when paired with bupropion an antidepressant and nicotine replacement therapies such as gum, patches, or lozenges.

While there are side effects to be aware of when taking Chantix, Galiatsatos says that the drug poses no more of a risk than commonly used antidepressants. However, some people, especially those with a history of mental illness, may experience serious adverse side effects, such as:

If you experience any of these symptoms, stop taking Chantix immediately and see your doctor.

Chantix works by delivering a one-two punch to smoking: It blocks nicotine from reaching receptors in the brain, which breaks the pleasure cycle of habitual smoking, and prevents cravings by releasing small amounts of dopamine.

Studies show that Chantix is particularly effective when paired with nicotine replacement therapies such as a nicotine patch. However, those on Chantix should pay close attention to any adverse side effects, especially mood changes, and check-in with your doctor if you experience them.

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Chantix may be the most effective way to quit smoking here's how it works - Insider - INSIDER

Recommendation and review posted by Bethany Smith

Covering COVID-19 is a daily Poynter briefing of story ideas about the coronavirus and other timely topics for journalists, written by senior faculty Al Tompkins. Sign up here to have it delivered to your inbox every weekday morning.

Over the weekend, President Donald Trump said the country needs and wants a second stimulus bill. But on Tuesday, President Trump called off any chance of a stimulus bill until after the November election.

Trump says he is asking Senate Majority Leader Mitch McConnell to spend his energy confirming Trumps Supreme Court nominee, Amy Coney Barrett, and not negotiate further with Democrats, who wanted $2.6 trillion in stimulus relief. The White House had offered $1.6 trillion.

Millions of unemployed Americans hoped to get another round of enhanced unemployment benefits. Even more Americans might have gotten a stimulus check, as they did in the spring.

The presidents order came just hours after Federal Reserve Chair Jerome Powell warned the nations economic recovery could falter without more federal stimulus. The Associated Press reported:

Powell said Tuesday that the risks of Congress pouring too much stimulus into the economy are far lower than the risk of not doing enough. Although government spending is adding to an already sky-high federal budget, lawmakers should act, Powell argued.

The presidents announcement came just before the stock market closed Tuesday, but in the short period left in the trading day, the Dow dropped 400 points.

The Dow Jones Industrial Average dropped minutes after the president called off talks with Democrats

Airlines, in particular, saw a selloff. Airlines had said they could reverse some of the more than 35,000 layoffs they announced last week if Congress could approve a stimulus bill.

The Senate has a two-week hold on floor sessions after three GOP senators tested positive for COVID-19. Many experts predict the election will not be settled for days or even longer after Election Day, so it is difficult to imagine Congress being able to successfully take on a multi-trillion-dollar relief package in the midst of disruption, particularly if the balance of power changes in the election.

Some business analysts Tuesday evening offered the notion that the president might be bluffing and will reengage in talks.

Air travel is going to be more complicated this year. Beyond all of the COVID-19 testing and mask-wearing, there are going to be a lot fewer flights. Southwest Airlines, for example, says it will have 90,000 fewer flights in November and December. The Dallas Morning News reported:

Southwest cut 38,000 flights from its November plans, or about 36% of all trips, according to Dallas-based Airline Data Inc. The carrier also cut 55,000 flights for December, nearly half of its schedule.

American Airlines announced this week it was cutting holiday season flights, too. American removed 86,000 flights, almost half of its normal schedule, from the November calendar.

Boeing said this week that the pandemic will hurt jet sales for more than a decade.

Six states are now in the process of reversing orders that reopened public gatherings, businesses and schools. Four more have paused further reopenings for now.

Wisconsin Gov. Tony Evers says starting Thursday morning, the state will reimpose restrictions on the size of indoor gatherings. Evers said, Were in a crisis right now and need to immediately change our behavior to save lives.

Wisconsin has four of the top 10 cities on The New York Times calculation of average daily cases compared to population over the last two weeks.

New polling from Axios/Ipsos finds about one in five Americans say President Trumps COVID-19 diagnosis makes them more likely to wear a mask and stay six feet away from other people.

(Ipsos)

Another poll, this one from Long Island University, finds that one in 10 Americans do not believe masks help prevent COVID-19 infections.

Journalists have repeatedly pointed out two COVID-19 risk factors that make President Trump more vulnerable to the virus. First is his age. The other is that he is obese.

What does obesity have to do with COVID-19 risk? It is a serious question since about 42% of American adults are obese.

Since the beginning of this pandemic, dozens of studies have shown obesity to be a key factor in who is likely to get the sickest from the virus. In one study involving 399,000 patients, People with obesity who contracted SARS-CoV-2 were 113% more likely than people of healthy weight to land in the hospital, 74% more likely to be admitted to an ICU, and 48% more likely to die.

One study of New York City COVID-19 cases found:

Being an individual with obesity increases the odds of COVID19 patients being hospitalized. Among diagnosed COVID19 patients, the prevalence of individuals with obesity in hospitalized patients was much higher than that in non-hospitalized patients. For example, a report that included 5700 patients with obesity in New York City showed that 41.7% of COVID19 hospitalized patients were individuals with obesity, whereas the average prevalence of individuals with obesity in New York City was 22.0%.

Another study of nearly 17,000 COVID hospitalized patients in the United States found 77% of those patients were either overweight or obese.

In fact, obesity is the No. 1 risk factor for developing a severe case of COVID-19 in people under the age of 55, warns Dr. Kyle Stephens, weight loss surgeon at Houston Methodist Hospital. Dr. Stephens says:

What we know historically from the influenza, tetanus and hepatitis B vaccines is that people who are obese seem to benefit less from vaccination than people who are at a healthy weight.

He adds that while researchers do not know exactly why vaccines do not work as well on obese people, it seems to have something to do with a chronic state of inflammation associated with obesity that interferes with a vaccines ability to do its work.

And obese patients are more likely to have other underlying health issues including diabetes, heart disease and lung disease which makes it more difficult to fight an invading virus.

Science Magazine described something physicians refer to as sticky blood that is associated with obesity:

For starters, the blood of people with obesity has an increased tendency to clot an especially grave risk during an infection that, when severe, independently peppers the small vessels of the lungs with clots. In healthy people, the endothelial cells that line the blood vessels are normally saying to the surrounding blood: Dont clot, says Beverley Hunt, a physician-scientist whos an expert in blood clotting at Guys and St. Thomas hospitals in London. But we think that signaling is being changed by COVID, Hunt says, because the virus injures endothelial cells, which respond to the insult by activating the coagulation system.

Add obesity to the mix, and the clotting risk shoots up. In COVID-19 patients with obesity, Hunt says, Youve got such sticky blood, oh my the stickiest blood I have ever seen in all my years of practice.

For a more detailed explainer on some of the theories about the connections between obesity and COVID-19, go to this study and flip down to Section 4.

I am not sure how well this claim would sit with the Food and Drug Administration if a mattress or pillow company tried to claim their product fights COVID-19. But National Geographic ran an interesting piece quoting Monika Haack, a psychoneuroimmunologist at Harvard Medical School, as saying, We have a lot of evidence that if you have an adequate amount of sleep, you definitely can help to prevent or fight any kind of infection.

When you do not get enough sleep, the body can reduce antibody responses to hepatitis A, hepatitis B and H1N1 swine flu vaccines. Researchers say one sleepless night might make a difference.

The story says:

Growing evidence also shows that sleep deprivation impairs a persons ability to fight off a disease once they are infected. In a number of studies, people with sleep disorders, people who catch less than five or six hours of shut-eye per night, and people with low levels of sleep efficiency (the percentage of time spent snoozing during the night) report higher rates of respiratory illnesses, head colds, and related ills.

In a 2019 study, Haack and colleagues listed more than three dozen ways that various immune-system players vary based on sleep changes. For instance, T cells are part of the immune system and are often described as the soldiers that fight infections. During sleep, according to studies by German researchers, T cells normally move out of the blood and likely into lymph nodes, where they conduct surveillance for invading pathogens, Haack says. But just one night of sleep deprivation, studies show, is enough to keep T cells circulating in the blood, making them less able to learn about and respond to invading viruses. When the body is denied sleep, T cells also become less able to interact with virus-infected cells, reducing their power to fight the infection.

Cytokines, a category of inflammatory molecules connected to the pandemic, are also a major focus of research on sleep and immunity. Pro-inflammatory cytokines normally help organize an immune response to infections, triggering other cells to come fight, says Sheldon Cohen, a psychoneuroimmunologist at Carnegie Mellon University. But the production of too many of these molecules adds up to a cytokine storm, an overreaction associated with severe and fatal cases of COVID-19. In studies of colds and influenza, infected people with poor sleep show worse symptoms, probably because elevated levels of pro-inflammatory cytokines interfere with T cells and other immune cells.

The National Geographic story points to a fascinating study from the University of California, San Francisco, and Carnegie Mellon University in Pittsburgh that took 164 healthy adults and squirted the virus connected with the common cold up their noses. The adults who slept less than six hours a night before being infected were more than four times more likely to get sick.

Other evidence shows that when you do not get enough sleep, you are more likely to make bad decisions that may include not adequately protecting yourself from viral hazards.

The Sleep Foundation says the pandemic is interrupting our sleep, even when we try to get enough rest. Worry, anxiety and working on computers late in the day before you go to bed are all sleep-killers. The blue light from screens can suppress the natural production of melatonin, a hormone that the body makes to help us sleep, the Sleep Foundation says.

Other ways the pandemic may be messing with your sleep:

It can be difficult to adjust to a new daily schedule or lack of a schedule.

Keeping track of the time, and even the day, can be hard without typical time anchors like dropping kids at school, arriving at the office, attending recurring social events, or going to the gym.

Being stuck at home, especially if it has low levels of natural light, may reduce light-based cues for wakefulness and sleep, known as zeitgebers, which are crucial to our circadian rhythm.

If you are not working at the moment or your weekly hours have been decreased due to COVID-19, you may be tempted to oversleep each morning. Sleeping more than seven to eight hours per night can make waking up on time much more difficult, even if you use an alarm. Oversleepers may also feel groggy, irritable and unfocused throughout the day.

Eddie Van Halen died, which just adds to the pain.

Joint Chiefs of Staff in quarantine,stock market tanks, stimulus talks collapse, learning to live with Covid, East Wing staff in full PPE, Pence doesnt want Plexiglas at debate. its barely noon on the West Coast!

Michael M. Grynbaum (@grynbaum) October 6, 2020

Dan Zak, White House correspondent for The Washington Post, documented a moment you never thought you would see. A guy in a hazmat suit walked through the West Wing press area with a sanitizing wand.

This is going on at the White House today. (This is the press area.) Video by @jabinbotsford. pic.twitter.com/46nFvIeKHs

Dan Zak (@MrDanZak) October 6, 2020

Well be back tomorrow with a new edition of Covering COVID-19. Sign up hereto get it delivered right to your inbox.

Al Tompkins is senior faculty at Poynter. He can be reached at atompkins@poynter.org or on Twitter, @atompkins.

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Coronavirus stimulus talks break down: There will be no stimulus until after the election - Poynter

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A transgender clinic offers "fairytale" promises to children because they are unable to give their consent to the sex-change process, the High Court has heard.

The case has been brought by 23-year-old Keira Bell, who began treatment to become a boy at 16 before later "de-transitioning", and "Mrs A", the unnamed mother of a 16-year-old girl who is on the waiting list to change gender.

They claim anyone aged 18 and under should only be prescribed hormone blockers which delay the onset of puberty with court supervision in place. Their legal action is against the Tavistock and Portman NHS Trust, which runs the country's only gender identity clinic for children.

Lawyers representing Keira Bell and "Mrs A" whose child is currently on the waiting list for treatment at the service argue that children going through puberty are "not capable of properly understanding the nature and effects of hormone blockers".

They arguethere is "a very high likelihood"children who start taking hormone blockers will later begin taking cross-sex hormones, which they say cause "irreversible changes".

Ms Bell and "Mrs A" are asking the High Court to rule it unlawful for children who wish to undergo gender reassignment to be prescribed hormone blockers without an order from the court that such treatment is in their "best interests".

At a hearing in London on Wednesday, the pair's barrister, Jeremy Hyam QC, said: "The use of hormone blockers to address gender dysphoria does not have any adequate base to support it."

He said it was "simply a fairytale" to think children of 13 or under can give informed consent to receive hormone blockers to delay puberty, adding that "a child who can't consent to any sexual activitycan't possibly give consent" to this treatment.

"We can't accept there can be an age appropriate discussion of the experiences a child has no experience of. It's just an affront to common sense to think that person is giving consent to that process," Mr Hyam said.

Children cannot properly understand the "lifelong medical, psychological and emotional implications" of taking "experimental" puberty blockers and cross-sex hormones, he told the court.

He said "the effect of hormone blockers on the intensity, duration and outcome of adolescent development is largely unknown", adding: "There is evidence that hormone blockers can have significant side-effects, including loss of fertility and sexual function and decreased bone density."

In written submissions, Mr Hyam said: "That children are not capable of giving informed consent to undergo a type of medical intervention about which the evidence base is poor, the risks and potential side-effects are still largely unknown, and which is likely to set them on a path towards permanent and life-altering physical, psychological, emotional and developmental consequences... is the common sense and obvious position."

The barrister told the courtreferrals to the NHS Gender Identity Development Service (Gids) had risen from 97 in 2009 to 2,590 in 2018, "essentially a 20-fold increase".

In a witness statement before the court, Ms Bell added: "I made a brash decision as a teenager, as a lot of teenagers do, trying to find confidence and happiness, except now the rest of my life will be negatively affected. Transition was a very temporary, superficial fix for a very complex identity issue."

However, Fenella Morris QC, representing the Tavistock and Portman NHS Trust, said the contention that children could not give informed consent to being prescribed hormone blockers was "a radical proposition".

She argued in written submissions that the claimants sought to "impose a blanket exclusion" on children under the age of 18 to be able to consent to medical treatment.

Ms Morris added the majority of children referred to Gids between March 2019 and 2020 were aged over 12, with only 13 of those referred being under the age of 13.

She argued that hormone blockers "had been widely researched and debated for three decades", adding: "It is a safe and reversible treatment with a well-established history."

Ms Morris also said the Tavistock and Portman NHS Trust referred children and young people experiencing gender dysphoria to University College London Hospitals NHS Foundation Trust or Leeds Teaching Hospital NHS Trust.

She told the court: "One cannot make a global statement that any child of any particular age is incapable of understanding these particular matters" as she reiterated "the importance of individual assessment".

She said those two trusts, not the Tavistock and Portman NHS Trust, were "responsible" for prescribing hormone blockers to children with gender dysphoria.

Lawyers representing London Hospitals NHS Foundation Trust and Leeds Teaching Hospital NHS Trust are expected to address the court on Thursday.

The hearing before Dame Victoria Sharp, Mr Justice Lewis and Mrs Justice Lieven is expected to last two days, and it is expected that the court will reserve its judgment to a later date.

The hearing continues.

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Gender clinic offers 'fairytale' promises to children over transitioning, court hears - Telegraph.co.uk

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Puberty-blocking treatment for children who are considering swapping gender provides time for deliberation and discussion and is reversible, the High Court has been told.

A 23-year-old woman who began taking puberty blockers when she was a teenager before "detransitioning" and the mother of an autistic girl are suing the UK's only gender identity development service (GIDS) for children.

However lawyers for the Tavistock and Portman NHS Trust, which runs the service, has defended hormone treatment which is given to children as young as 10.

The case has been brought against the country's only gender identity clinic for children by two claimants - the mother of a 16-year-old on the waiting list for treatment and Keira Bell who transitioned to a boy in her teens but has since stopped taking testosterone.

Lawyers representing the pair argue that children going through puberty are "not capable of properly understanding the nature and effects of hormone blockers".

They are asking the High Court to rule it is unlawful for children who wish to undergo gender reassignment to be prescribed hormone blockers without an order from the court that such treatment is in their "best interests".

Fenella Morris QC, representing the Tavistock and Portman NHS Trust which runs the service, said every consent decision involves explaining to each child the consequences of their decision in the future.

She added that it is up to clinicians to make sure they understand and if that child is deemed unable to grasp the consequences, they will not be given the puberty-blockers until that child's "understanding of themselves and the world grows".

The court previously heard that referrals to GIDS had risen from 97 in 2009 to 2,590 in 2018, "essentially a 20-fold increase".

Lawyers for the hospitals which prescribe the treatment told the court how a 10-year-old could begin taking puberty-blockers and go on to "mature and have further life experiences".

At 14 or 15 they could stop taking the treatment to enable them to have eggs harvested in case they decided to have children later, they added.

They went on to say that a child of 10 can "understand their body and the changes of their body" and can have "gender dysphoria which is causing them distress".

The court heard there is no alternative treatment to the hormone blockers.

Keira was 16 when she began taking the puberty-blocking drugs and the following year began taking the cross-sex hormone testosterone, before have a double mastectomy at the age of 20.

She told Sky News that once on hormone blockers "it's hard to get off because you are already on a medical pathway and even at that point you feel that you cannot turn back".

"I was completely convinced the physical transition and medical transition was what I wanted to do.

"I was so distressed at the time and I fit the criteria I thought it would change my life for the better."

She now describes that as a "brash decision".

On Wednesday, Ms Morris QC told the court the contention that children could not give informed consent to being prescribed hormone blockers was "a radical proposition".

She argued in written submissions that the claimants sought to "impose a blanket exclusion" on children under the age of 18 to be able to consent to medical treatment.

Ms Morris added the majority of children referred to GIDS between March 2019 and 2020 were over 12, with only 13 of the children referred being under the age of 13.

The hearing before Dame Victoria Sharp, Mr Justice Lewis and Mrs Justice Lieven is in its second and final day.

It is expected that the court will reserve its judgment to a later date.

Lui Asquith, legal and policy director for the charity Mermaids, which supports transgender children, said: "If this case were successful, it would prevent trans young people from being able to take their own medical advice, heralding a new era of minority discrimination in England and Wales."

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Puberty-blocking treatment for children 'provides time and is reversible', High Court hears - Sky News

Recommendation and review posted by Bethany Smith

This transcript has been edited for clarity.

Hi. It's Dr Kathy Miller from Indiana University. I just finished a phenomenal science weekend at the European Society for Medical Oncology (ESMO) virtual congress, and I want to share some of the breast cancer data with you.

I remember being taught early in my career that a hallmark of good science, whether it's conducted in a laboratory or in the clinic, is that it forces you to ask more questions than it answers. And if that is the case, we saw some really good science this weekend. I want to review two sets of studies with you that have seemingly similar study designs but came to dramatically different conclusions.

First, let's think about the cyclin-dependent kinase (CDK) inhibitors in the adjuvant setting.

We saw the results of the PALLAS trial that studied over 4000 largely stage II and III patients (about 1000 had stage IIA disease, so lymph nodenegative patients were allowed to enroll) who were randomized to 2 years of palbociclib or not. It was stopped for futility at the second interim analysis. To be clear, the study was not stopped, but the data monitoring committee suggested that all patients still on palbociclib should stop therapy and enter follow-up. Those patients, along with those who had already finished the 2 years of therapy, will be followed for at least the next 10-15 years. But there was no suggestion of benefit in the overall trial results and no suggestion of any clinical subset that might benefit, including a high-risk subset about 59% of patients who would have met the high-risk definition in the monarchE trial.

Now, let's contrast that with the monarchE results. It was a very similar study design, with over 5000 high-risk patients (stage IIA, lymph nodenegative patients were not eligible) randomized to 2 years of abemaciclib or not. There was earlier follow-up of only about 15 months, but it was a positive trial nonetheless, with about a 3%-3.5% improvement in invasive disease-free survival and distant recurrence-free survival.

How could these two drugs that look so similar in the metastatic setting have given such different results in the adjuvant setting? There are quite a number of potential reasons:

It could be pure chance. Any study, no matter how many zeros in the P value, could be simply the play of chance. And that is true for negative and positive studies.

It could be that the study design was wrong. Remember, these are agents that we think of as reversing endocrine resistance and extending the benefit of hormone therapy. And yet we looked at very early results. These are early recurrences, the sort of recurrences we typically think of as being affected by chemotherapy and less affected by hormone therapy. Perhaps the study design was just wrong for palbociclib.

Even though these drugs were designed to inhibit CDK4/6, their relative potency for those two CDK inhibitors, as well as the other activity of those drugs, clearly differ. In a metastatic setting, that did not seem to affect effectiveness, but it clearly affected the toxicity profile. Perhaps in the adjuvant setting, those differences really do drive differences in efficacy.

Perhaps this is an issue of drug exposure. About 40% of patients in the PALLAS trial with palbociclib stopped therapy before completing the full 2 years of treatment, largely driven by protocol-defined toxicity, but not entirely. That compares with only about 16% of patients in the abemaciclib trial.

We also need to think more carefully about the regions of the world where these trials were done. The PALLAS trial was almost entirely done in high-resourced, well-developed countries with well-established medical systems. The monarchE trial had a little bit greater diversity of countries. It included some low-resource countries, so perhaps this represents a difference in the number of patients with very high-risk multiple nodepositive disease who underwent extensive staging. And though some of the patients in the monarchE trial had clinically occult but present metastatic disease, this represents simply treatment of early metastasis.

I have no answers for why these two trials are different. It's going to take a lot more data and a lot more time to understand this. But it sure does make you think, and that is clearly a hallmark of good work. Congratulations to the authors of both of these studies. I look forward to your thoughts.

Kathy D. Miller, MD, is associate director of clinical research and co-director of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University. Her career has combined both laboratory and clinical research in breast cancer.

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Opposing Trial Results on CDK Inhibitors Means Good Science - Medscape

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A new group of nonhormonal drugs currently in clinical trials shows strong promise for treating menopausal hot flashes as effectively as hormones, researchers told attendees at the virtual North American Menopause Society (NAMS) 2020 Annual Meeting.

"The [kisspeptin/neurokinin B/dynorphin (KNDy)] neuron manipulation is really exciting and holds great promise for rapid and highly effective amelioration of hot flashes, up to 80%, and improvement in other menopausal symptoms, though we're still looking at the safety in phase 3 trials," reported Susan D. Reed, MD, MPH, director of the Women's Reproductive Health Research Program at the University of Washington in Seattle.

"If we continue to see good safety data, these are going to be the greatest things since sliced bread," Reed told Medscape Medical News in an interview. "I don't think we've seen anything like this in menopause therapeutics in a long time."

While several nonhormonal drugs are already used to treat vasomotor symptoms in menopausal women with and without breast cancer, none are as effective as hormone treatments.

"For now, the SSRIs, SNRIs and GABAergics are the best frontline nonhormonal options with a moderate effect, and clonidine and oxybutynin are effective, but we see more side effects with these," Reed said. She noted the importance of considering patients' mood, sleep, pain, sexual function, weight gain, overactive bladder, blood pressure, and individual quality of life (QOL) goals in tailoring those therapies.

But women still need more nonhormonal options that are at least as effective as hormonal options, Reed said. Some women are unable to take hormonal options because they are at risk for blood clots or breast cancer.

"Then there's preference," she said. "Sometimes people don't like the way they feel when they take hormones, or they just don't want hormones in their body. It's absolutely critical to have these options available for women."

Nanette F. Santoro, MD, a professor of OB/GYN at the University of Colorado Anschutz Medical Campus in Denver, who was not involved in the presentation, told Medscape Medical News that physicians may not always realize the extent to which vasomotor symptoms interfere with women's daily lives.

"They have an eroding effect on QOLthat is not appreciated sometimes," she said. Though hot flashes eventually subside in most women, others may continue to experience them into their 70s, when hormonal therapies can begin causing more harm than benefit.

"It goes under-appreciated that for a proportion of women, hot flashes will never go away, and they're just as bad [as] when they were in their 50s," Santoro said. "They need to be treated, and the non-hormonal treatments do not work for everybody."

Autopsy studies of postmenopausal women revealed that a complex of neurons in the hypothalamus was "massively hypertrophied" and sits right next to the thermoregulatory center of the brain, Reed explained.

The complex produces three types of molecules: kisspeptin (a neuropeptide), neurokinin B (a neuropeptide), and dynorphin (a kappa opioid), collectively referred to as the KNDy. The KNDy neural complex is located in the same place as the majority of hormone receptors in the arcuate nucleus, a collection of nerve cells in the hypothalamus.

The current hypothesis is that the KNDy neurons, which communicate with each other, become hyperactivated and cause hot flashes by spilling over to and triggering the thermoregulatory center next door. NKB (kisspeptin and neurokinin B) agonists activate KNDy neurons and dynorphin agonists inactivate KNDy, so the expectation is that NKB antagonists or dynorphin agonists would stop hot flashes.

Indeed, research published in 2015 showed that women taking agonists experienced fewer hot flashes than women in the placebo group. However, no peripherally restricted agonists are currently in clinical trials, so their future as therapeutics is unclear.

Right now, three different NK antagonists are in the pipeline for reducing vasomotor symptoms: MLE 4901 (pavinetant) and ESN364 (fezolinetant) are both NK3R antagonists, and NT-814 is a dual NK1R/NK3R antagonist. All three of these drugs were originally developed to treat schizophrenia.

Phase 2 clinical trials of pavinetant were discontinued in November 2017 by Millendo Therapeutics because three of 28 women experienced abnormal liver function, which normalized within 90 days. However, the study had shown an 80% decrease in hot flashes in women taking pavinetant compared with a 30% decrease in the placebo group.

Fezolinetant, currently in phase 3 trials with Astellas, showed a dose response effect on reproductive hormones in phase 1 studies and a short half-life (4-6 hours) in women. It also showed no concerning side effects.

"There was, in fact, a decrease in the endometrial thickness, a delayed or impeded ovulation and a prolonged cycle duration," Reed said.

The subsequent phase 2a study showed a reduction of five hot flashes a day (93% decrease) compared with placebo (54% decrease, P <.001) "with an abrupt return to baseline hot flash frequency after cessation," she said. Improvements also occurred in sleep quality, quality of life, disability, and interference of hot flashes in daily life.

The phase 2b study found no difference in effects between once-daily vs twice-daily doses. However, two severe adverse events occurred: a drug-induced liver injury in one woman and cholelithiasis in another, both on the 60-mg, once-daily dose. Additionally, five women on varying doses had transient increases (above 1000 U/L) in creatinine kinase, though apparently without dose response.

A 52-week, three-arm phase 3 trial of fezolinetant is currently under way with a goal of enrolling 1740 participants, and plans to be completed by December 2021. Participants will undergo regular adverse event screening first biweekly, then monthly, with vital signs, blood, and urine monitoring.

Meanwhile, NT-814 from KaNDy Therapeutics, has completed phase 2a and phase 2b trials with phase 3 slated to begin in 2021. Adverse events in phase 1 included sleepiness and headache, and it had a long half-life (about 26 hours) and rapid absorption (an hour).

The phase 2a trial found a reduction of five hot flashes a day compared with placebo, with main side effects again being sleepiness and headache. No events of abnormal liver function occurred. Phase 2b results have not been published.

So far, existing research suggests that KNDy interventions will involve a single daily oral dose that begins taking effect within 3 days and is fully in effect within 1 to 2 weeks. The reduction in hot flashes, about five fewer a day, is more effective than any other currently used nonhormonal medications for vasomotor symptoms. SSRIs and SNRIs tend to result in 1.5-2 fewer hot flashes a day, and gabapentin results in about three fewer per day. It will take longer-term studies, however, and paying attention to liver concerns for the NK3R antagonists to move into clinic.

"We want to keep our eye on the [luteinizing hormone]because if it decreases too much, it could adversely affect sexual function, and this does appear to be a dose-response finding," Reed said. It would also be ideal, she said, to target only the KNDy neurons with NK3 antagonists without effects on the NK3 receptors in the liver.

Oxybutynin is another a nonhormonal agent under investigation for vasomotor symptoms. It's an anticholinergic that resulted in 80% fewer hot flashescompared with 30% with placeboin a 2016 trial, but 52% of women complained of dry mouth. A more recent study similarly found high efficacy a 60%-80% drop in hot flashes compared with 30% with placebo but also side effects of dry mouth, difficulty urinating, and abdominal pain.

Finally, Reed mentioned three other agents under investigation as possible nonhormonal therapeutics, though she has little information about them. They include MT-8554 by Mitsubishi Tanabe, FP-101 by Fervent Pharmaceuticals, and Q-122 by QUE Oncology with Emory University and the University of Queensland.

None of the currently available nonhormonal options provide as high efficacy as hormones, but they do reduce symptoms:

Clonidine is an off-label option some physicians already use as a nonhormonal treatment for vasomotor symptoms, but again, the side effects are problematic: dry mouth, constipation, drowsiness, postural hypotension, and poor sleep.

Paroxetine, at 7.5-10 mg, is the only FDA-approved nonhormonal treatment for vasomotor symptoms, but she listed other off-label options found effective in evidence reviews: gabapentin (100-2400 mg), venlafaxine (37.5-75 mg), citalopram (10 mg), desvenlafaxine (150 mg), and escitalopram (10 mg).

"I want you to take note of the lower doses in all of these products that are efficacious above those doses that might be used for mood," Reed added.

Reed receives royalties from UpToDate and research funding from Bayer. Santoro owns stock in MenoGeniX and serves as a consultant or advisor to Ansh Labs, MenoGeniX, and Ogeda/Astellas.

Follow Medscape on Twitter @Medscape and Journalist Name @tarahaelle.

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New Nonhormonal Hot Flash Treatments on the Way - Medscape

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WOMEN are being assured it is safe to attend breast screening services in South Cumbria.

The risk increases with age, which is why all people between the ages of 50 to 70 who have breasts, due to either naturally occurring oestrogen or oestrogen hormone therapy are invited for screening every three years.

Breast cancer can affect anyone with breasts, so some trans or non-binary people are also eligible for screening talk to your GP or Gender Identity Clinic about this.

Breast screening aims to find breast cancers early. In the meantime, if youre worried about breast cancer symptoms such as a lump or an area of thickened tissue in the breast, or you notice that your breasts look or feel different, do not wait to be offered a screening appointment, talk to your GP.

Georgia Argent, programme lead at University Hospitals of Morecambe Bay NHS Foundation Trust said: Breast screening involves having an X-ray (mammogram) at a special clinic or mobile breast screening unit. You will have the chance to talk about any problems or concerns you have. As you will need to undress to the waist, it may be easier to wear trousers or a skirt rather than a dress.

Usually two X-rays of each breast are taken one from above and one from the side. A plastic plate will be gently but firmly pressed onto your breast so that they can get clear pictures. The X-ray test can spot cancers when theyre too small to see or feel.

The mammogram will be checked for any abnormalities, and the results will be sent to you and your GP within two weeks.

Dr Neil Smith, primary care director and Cancer Research UK GP for Lancashire and South Cumbria Cancer Alliance said: Breast cancer can affect you at any age, so its important to be Breast Aware and check your breasts for lumps or a change in size or shape at least once a month. If you notice anything unusual, please dont wait contact your GP straight away.

In most cases it wont be cancer, but its best to get checked over because early diagnosis saves lives.

Read more:
'It's safe to attend breast screening' - NW Evening Mail

Recommendation and review posted by Bethany Smith

October8, 20206 min read

Opinions expressed by Entrepreneur contributors are their own.

Covid-19has taught us that we are more than the AI machines we covet.

We are more than a series of tasks that must be completed on time-blocked calendars.

More than hopping on Zoom calls, Slack pings and Facebook DMs.

We are more than the definition of a hustler. No, we are the whole and holistic fragments that need attending to. We are what fulfills us.

Once lockdown hit, it quickly became apparent that what we thought was important wasnt. We didnt die when we rescheduled meetings and prioritized scared children over clients. The peace we had wished to descend into a life of busyness finally did. And for a minute it seemed like our existence would be a free-for-all. Because that is what humans know how to do.

Work a bazillion hours a day or do nothing at all.

Theres never anything in between.

But life is meant to be lived in the in-between. Thats where it gets good.

We finally got permission to ease up on the grind. Maybe that is why we can now explore new solutions to old problems. But why didnt we listen to our brains that threatened to sizzle and fry before it was the end of the world as we knew it?

The hustle mentality. It was quite good at sucking us in.

Ive been reinventing the hustle since I got sick in 2014 and had to quit working due to long-term Lyme and other coinfections and diseases. Since 2016 Ive gone deep down the rabbit hole and connected with well over 100 coaches, studying what the common keys behind success are.

Well, guess what? The truth is in the middle.

Its in the anti-hustle, or as I like to call it, the sick hustle.

Related:3 Strategies to Help You Create a Meaningful Work-Life Balance in the Midst of Covid-19 Chaos

Its in the way that you prioritize what will keep your business running, but it also centers on what will keepyourunning. After all, without you, there is no business.

These six simple tenets came from my disrupted life. They will allow you to get done what you need without driving yourself into the ground with some cool health benefits, too.

These aspects of our lives might seem like they have nothing to do with work, but they do. When you are pushed so hard to do so much because of the volume you worked to stack in your pipeline, you can resent what you do. That doesnt sound like working in a passion to me.

My research for this article pointed me to this quote by Elena Touroni, Ph.D., a consultant psychologist and co-founder of the Chelsea Psychology Clinic in London: Being always on increases our stress levels and reduces our productivity significantly.

Yep, we are designed this way, to do less.

Related:Switch Off Covid-19 Stress: 5 Ways to Achieve Work-life Balance in the New Normal

If thats not enough, I found more research telling us to slow it down. Dena M. DiNardo, Psy.D., a clinical psychologist in Philadelphia, notes that a constant hustle sets us up for a letdown. It can perpetuate feeling like your skills or knowledge expire shortly after theyre acquired, and like theres always something more we need to be doing to stay relevant.

Then I stumbled upon this mind-blowing truth from George Arabian, CEO of Nvision: You only hear about the success stories and not the casualties of this mentality.

Its true. Society and the self-made community have slapped a big label on what success means and what it doesnt.

Nearly kill yourself, while leaching from every aspect of your life to build your business: win.

Exercise strategic pauses that equal less volume but more gratification while nurturing all parts of your life: lose.

But how have you grown if you are too sick, fatigued, sad and stressed to enjoy the fruits of your labor?

The CDC notes, Working too hard is the opposite of self-care. Just more evidence that whether we want to hear it or not, the hustle is not good for us.

Overworking and stress also contribute to cardiovascular diseases, musculoskeletal issues, diabetes, and an increased risk of stroke and cancer. Keep dumping the high-stress hormone cortisol in your bod, too, and prepare for a chronic illness. The cherry is back and neck pain from muscle tension. This is why healthcare costs for high-stressed people are nearly fifty percent higher than less-stressed people.

There is no better time to ask yourself if what you are doing and how you are doing it is worth it.

Life and work must be sustainable for a business to last. It took a pandemic to force us inside our homes and heads. We can use this time to rearrange our priorities the way we wish we would have from the jump, to plan for and handle the day-to-day without overwhelm.

My trajectory screeched to a halt when I had to reinvent myself. I am grateful and have mused many times that not many people have the chance to start over and change the record, mid-play.

But now every waking individual gets that opportunity. The shot at embracing a new era: the anti-hustle of entrepreneurship. Lets not waste this gift, only to awaken years in the future, wishing we had capitalized on the unbelievable time the entire world rebooted.

Related:3 Tips That Can Help You Read More Books This Year

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Welcome to the Era of the Anti-Hustle - Entrepreneur

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Chantix, the brand name version of a drug called varenicline, is a nicotine-free prescription pill used to help people quit smoking gradually. Unlike nicotine replacement therapies,varenicline blocks the brain from getting pleasure due to nicotine.

Smoking is the leading cause of preventable death worldwide. This is likely because its so difficult to quit, thanks to how nicotine affects the brain.

When you smoke, nicotine attaches to receptors located in the brains reward centre. This causes those receptors to release dopamine, a hormone that elicits feelings of pleasure. Once that dopamine rush wears off, you begin to crave nicotine, says Panagis Galiatsatos, MD, the director of the Tobacco Treatment Clinic at Johns Hopkins Medicine.

Chantix helps break this nicotine addiction in two ways:

When smoking becomes an addiction, your brain associates certain smells, locations, or emotions with the action. This makes you want to smoke when youre in certain situations, even if your brain isnt in need of a dopamine rush, says Galiatsatos.

If you smoke on Chantix, not only will it be unsatisfying, but it will also break the association between specific circumstances and the need to smoke.

If you try to smoke [while on Chantix], it wont be successful, says Galiatsatos. Varenicline also keeps [higher] dopamine [levels] in the brain, satisfying pleasure sensors without nicotine, and cuts cravings.

Chantix is available by prescription only and is usually prescribed for 12 weeks. Its important to speak with your healthcare provider to determine the right dosage and plan for you.

There are three proven ways you can use Chantix to quit smoking:

How long quitting takes will depend largely, but not solely, on your smoking habit. Some patients can quit immediately but others need to be on it for longer than 12 weeks. Guidelines are fine but they are not rules, you have to adapt treatment to the patient, Galiatsatos says.

In the United Kingdom, one in four people who quit smoking were using Chantix.

A 2020 report found that experts specializing in tobacco addiction recommended that those who wish to quit smoking take varenicline over all other treatment options. The experts also recommended pairing Chantix with a nicotine patch.

A 2016 review also found that varenicline is the most effective single-use agent for treating tobacco addiction. Two large trial studies compared smokers who took either varenicline, bupropion, or a placebo for 12 weeks. It found that 44% of those in the varenicline group had successfully quit smoking four weeks after they completed their 12-week dose, compared to 30% in the bupropion group and 18% in the placebo.

The study also found that the efficacy of varenicline is improved when paired with bupropion an antidepressant and nicotine replacement therapies such as gum, patches, or lozenges.

While there are side effects to be aware of when taking Chantix, Galiatsatos says that the drug poses no more of a risk than commonly used antidepressants. However, some people, especially those with a history of mental illness, may experience serious adverse side effects, such as:

If you experience any of these symptoms, stop taking Chantix immediately and see your doctor.

Chantix works by delivering a one-two punch to smoking: It blocks nicotine from reaching receptors in the brain, which breaks the pleasure cycle of habitual smoking, and prevents cravings by releasing small amounts of dopamine.

Studies show that Chantix is particularly effective when paired with nicotine replacement therapies such as a nicotine patch. However, those on Chantix should pay close attention to any adverse side effects, especially mood changes, and check-in with your doctor if you experience them.

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Chantix may be the most effective way to quit smoking here's how it works - Business Insider Australia

Recommendation and review posted by Bethany Smith

Equinox Gold(TSX: EQX; NYSE: EQX) has announced an increase in reserves and resources at its Mesquite open-pit heap leach gold mine in California, about 56 km east of Brawley, and 84 km northwest of Yuma in Arizona.

According to the junior mining company, estimated proven and probable reserves increased by 142,267 oz. of gold as of Jun. 30, up 28% from the previous estimate in Dec. 2019, and now stands at 37.8 million tonnes grading 0.54 gram gold per tonne for 658,000 oz. contained gold. The estimate, the company said, is net of mining depletion amounting to 68,267 oz. gold during the first half of 2020.

Measured and indicated resources are estimated at 66.7 million tonnes grading 0.39 gram gold for 837,000 oz. of gold, a 94% increase from the Dec. 2019 estimate of 432,000 ounces.

Inferred resources rose by 193,000 oz. to 69.2 million tonnes grading 0.32 gram gold for 703,000 oz. of gold, a 38% increase over the same period.

The mid-year update, the company said, incorporates an additional 77 drill holes over 10,785 metres of bedrock drilling, 661 holes totalling 36,785 metres of drilling targeting historical dumps, and updated geologic and grade-shell domains.

At the end of 2019, the company had identified approximately 36 million tonnes of potentially mineralised material from previous operations that had not been drill tested and initiated a 35,000-metre exploration drill program.

Drilling in the Big Chief, Midway, and Brownie waste dumps at Mesquite yielded significant gains in mineral resources, the company reported. Indicated resources in the dumps increased more than four-fold to 22.7 million tonnes grading 0.22 gram gold for 160,000 oz. contained gold and inferred resources rose by 31% to 36.6 million tonnes grading 0.22 gram gold for 225,000 ounces. The increase did not reflect the depletion of resource material contained in the 2019 mineral resource that had already been stacked on the leach pad, the company noted.

Drilling in 2019, the company reported, confirmed that the dump material overlying the Brownie deposit area contained gold resources and that in-situ mineralisation was present adjacent to and extending from the resource pit.

A follow-up 13,897 metre drill program on the Brownie deposit was undertaken to test the potential to extend mineralisation along strike and down dip. Highlights included 35.1 metres grading 0.51 gram gold; 33.5 metres grading 0.66 gram gold; 52.6 metres grading 0.85 gram gold; and 44.2 metres grading 0.58 gram gold.

The results, the company said, increase its confidence in the geological model and highlight the potential for further expansion potential to the north, northwest, and southeast of existing resources.

Exploration efforts at Mesquite in the first half of 2020 more than replaced mined reserves and significantly increased mineral resources, providing additional mine life at what has been our best-performing mine this year, Scott Heffernan, Equinoxs executive vice president of exploration, stated in a press release.

Drilling in the Brownie deposit also yielded excellent results and points to the potential for a multi-year mine life extension from in-situ mineralization and overlying mineralized dumps.

At press time in Toronto, Equinox was trading at $15.62 per share within a 52-week trading range of $6.60 and $17.99.

The company has around 241 million common shares outstanding for a $3.8-billion market capitalization.

Excerpt from:
Equinox Gold updates reserves and resources for Mesquite mine in California - The Northern Miner

Recommendation and review posted by Bethany Smith

This article was originally published here

J Racial Ethn Health Disparities. 2020 Oct 6. doi: 10.1007/s40615-020-00878-5. Online ahead of print.

ABSTRACT

Prior to embarking on a large descriptive evaluation of genetic/racial variations in symptom phenotype, we sought foundational information to determine racial differences in (1) feasibility (consent) and acceptability of collecting genomic samples, (2) genetic literacy, and (3) concerns of genomic research during breast cancer (BC) chemotherapy. Women with early-stage BC undergoing chemotherapy were recruited from an academic, urban breast care center. Information was collected for consent to participate, genetic literacy, and concerns about genetic testing in Black and White women with BC. Fifty-six women were eligible, and 48 were consented (24 Black, 24 White). All participants consented to blood testing. This highly educated samples mean age was 52.5 + 12.05 (years). Education (years) and genetic knowledge were positively correlated (p = .038). Genetic scores were high, and only one question significantly differed by race. On interview, most participants thought conducting genetic research helped to better understand hereditary disease and/or identify genes that cause disease and stated that they participated in the research to help other people. The majority of participants responded that friends/family would participate in genetic research without concerns, though three Black participants cited mistrust as a possible concern. Overall, there were high levels of genetic knowledge, slightly different between Black and White women. There were no high levels of personal concern regarding genetic testing. Black women reported more concern than White women that friends/family would have hesitations about participating in genetic research. There was general acceptability of blood collection for genetic testing among women with early-stage BC without racial difference.

PMID:33025420 | DOI:10.1007/s40615-020-00878-5

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Knowledge and Attitudes About Genetic Testing Among Black and White Women with Breast Cancer - DocWire News

Recommendation and review posted by Bethany Smith

When Dalyss Tomayer found out three of her relatives had had breast cancer, it was enough to qualify her for the genetic testing which showed she had a high risk of breast cancer herself.

Tomayer was able to discover the gene early due to getting tested at HCA Houston Healthcare North Cypress High Risk Breast Clinic, where they offer genetic testing for those who qualify to see if they may have the BRCA1 or BRCA2 gene which puts people at higher risk for breast cancer.

On HoustonChronicle.com: Willowbrook breast cancer support group still meeting virtually

I had known for years that two of my dads sisters had breast cancer, and it was in speaking with one of my aunts that I then found out also one of my cousins had breast cancer, Tomayer said. So, it was at that time that I realize that I did qualified for the genetic testing and I decided to go ahead and do it.

Janet Pollard, the coordinator for the High Risk Breast Clinic, said the breast center began as a full program under HCA Houston North Cypress CEO Jim Brown, who she said was passionate about having this resource.

On HoustonChronicle.com: Memorial Hermann rolls out breast cancer prevention program as screening rates plummet

Most of the time people think about genetic testing after you get cancer, Pollard said. It can drive the type of surgeries, it can change treatment regime, but basically its getting it done prior. Its screening people when they come in for their annual mammograms, talking with primary care doctors, educating them on what makes patients meet criteria.

Criteria established by the American Cancer Society for genetic testing includes people who were diagnosed with breast cancer at a younger age, those diagnosed with breast cancer a second time, people of Ashkenazi Jewish descent, people with a family history of breast cancer, ovarian cancer, pancreatic cancer or prostate cancer, and people with a known family history of BRCA mutation.

Before the pandemic, Pollard said the center was testing around 30 people a month, men and women, with about 10 percent of people testing coming back positive.

BRCA1 and 2 genes are huge red flags, Pollard said. Theyre the original genes and theyve been testing those genes for two decades.

The process Tomayer chose to go through after being tested was to have a double mastectomy to virtually remove all chance of breast cancer, as well as a hysterectomy to eliminate her chances of ovarian cancer.

Even though you do a double mastectomy, theres no way to get 100 percent of every breast cell in my body, so there is still a slight chance, but it is incredibly slight, she said.

Tomayer said she would continue to have ultrasounds for what remaining breast tissue she has left.

Im so very thankful they have the test, Tomayer said. It saved my life.

paul.wedding@hcnonline.com

Continued here:
HCA Houston Healthcare North Cypress offers preventative gene testing for breast cancer - Chron

Recommendation and review posted by Bethany Smith

SAN DIEGO, Oct. 08, 2020 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) announced today that its Saphyr system played a key role in a research study by Marcin Imielinski, M.D., Ph.D., Assistant Professor of Pathology and Laboratory Medicine at Weill Cornell Medical School, which was published in the peer-reviewed journal Cell. The study identified three new distinct classes of structural variations (SVs) in the DNA of thousands of cancer samples across multiple cancer types, and used Saphyr to characterize the precise structure and genomic location of these variations. These previously unknown types of complex rearrangements help explain different mechanisms that enable cancer cells to expand and grow rapidly while simultaneously evading natural defense mechanisms and treatment. With the addition of Bionanos Saphyr data, the study demonstrated that these structural variants generate a large number of fusion proteins and represent therapeutic targets and/or prognostic biomarkers of disease progression.

While cancer genomes traditionally have been studied with a combination of low-resolution cytogenetic methods or with next-generation sequencing (NGS), Bionanos Saphyr instrument provides long-range data that enables a high-resolution, long-range view into the cancer genome and cancer biology. At a presentation providing an update on the study given at the March 31, 2020 Advances in Genome Biology and Technology Conference, Dr. Imielinski explained how short-read data alone is unable to resolve the structure of these newly discovered structural variants because short reads provide a very local view of the genome, and further explained how integrating long-range data generated by Bionanos optical mapping technology was essential to obtaining a complete understanding of these structures, including their biological significance.

As previously announced, a high-profile paper published last month by UCSD Professor Vineet Bafna in Nature Communications similarly used a combination of NGS and Bionanos Saphyr data to resolve the structure of extra-chromosomal circular DNA, another type of complex rearrangement of the cancer genome which similarly allows for tumor cells to increase their growth rate while evading natural defenses. In both studies, only the combination of short-read sequencing technology with optical mapping data generated by Saphyr was able to fully resolve these complex structures and provide a comprehensive picture of the cancer genome.

We are impressed by this important body of work and the ingenuity from Dr. Imielinskis team," said Erik Holmlin, Ph.D., chief executive officer of Bionano Genomics. By combining NGS with Bionanos genome imaging data, they were able to discover, analyze and fully characterize these novel variants that were so large and complex that they were hidden in plain sight from traditional sequencing methods. We believe these studies help generate a rapid increase in understanding of the complexity of cancer genomes driven by the long-range data that only Saphyr can provide, with a cost and throughput that makes the analysis of large sets of cancer samples possible. Since many of the most effective anti-cancer drugs target specific fusion proteins, we believe the discovery of these novel structural variants and the many fusions they generate has the potential to guide the future development of new therapeutics, better cancer diagnostics and a more efficient use of existing cancer drugs.

The publication is available at https://doi.org/10.1016/j.cell.2020.08.006

About Bionano GenomicsBionano is a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing, and providing diagnostic testing for those with autism spectrum disorder (ASD) and other neurodevelopmental disabilities through its Lineagen business. Bionanos Saphyr system is a platform for ultra-sensitive and ultra-specific structural variation detection that enables researchers and clinicians to accelerate the search for new diagnostics and therapeutic targets and to streamline the study of changes in chromosomes, which is known as cytogenetics. The Saphyr system is comprised of an instrument, chip consumables, reagents and a suite of data analysis tools, and genome analysis services to provide access to data generated by the Saphyr system for researchers who prefer not to adopt the Saphyr system in their labs. Lineagen has been providing genetic testing services to families and their healthcare providers for over nine years and has performed over 65,000 tests for those with neurodevelopmental concerns. For more information, visitwww.bionanogenomics.com or http://www.lineagen.com.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, expect, plan, anticipate, estimate, intend and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Bionanos contribution to understandings of extra-chromosomal circular DNA and structural variations in cancer, including its ability to influence improved use of existing cancer drugs or future development of better diagnostics and new therapeutics; Saphyrs capabilities in comparison to and in conjunction with traditional sequencing methods and NGS-based methods; and Saphyrs potential as an essential tool for personalized medicine and furthering understanding of cancer in the medical community. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive products; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; the loss of key members of management and our commercial team; and the risks and uncertainties associated withour business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionanogenomics.com

Investor Relations Contact:Ashley R. RobinsonLifeSci Advisors, LLC+1 (617) 430-7577arr@lifesciadvisors.com

Media Contact:Darren Opland, PhDLifeSci Communications+1 (617) 733-7668darren@lifescicomms.com

Continued here:
Bionano's Saphyr Plays Essential Role in Identifying Three Previously Unknown Genetic Mutation Types in Cancer in Study from Weill Cornell -...

Recommendation and review posted by Bethany Smith

by Liz Bonis & Merby Curtis, WKRC

Experts at St. Elizabeth Healthcare are expanding programs to treat and prevent cancer. Its all part of a personal prescription for your future health. (WKRC)

EDGEWOOD, Ky. (WKRC) Experts at St. Elizabeth Healthcare are expanding programs to treat and prevent cancer. Its all part of a personal prescription for your future health.

For years, we have focused on early detection of cancer, which is important. But now, the new St. Elizabeth Cancer Center has an important focus on preventing cancer with the help of screening that also detects risk: a field commonly called precision medicine.

The new Cancer Center has several teams dedicated to making this happen. Medical oncologist Dr. Brooke Phillips explains how it all works together:

One of the first things in cancer is trying to prevent it. We already have a robust genetic counseling program, but were going to have a whole floor dedicated to that. Were seeing not only patients that have cancer, but patients that have a family history or concerns related to that and will provide them care, really, in regards of prevention. If that involves screening tests, prophylactic surgeries, we will also have that in there. We will also have precision medicine as related to a specific tumor and a lot of genetic related to that tumor and a lot of clinical trials surrounding that.

If you know you have a family history of cancer and would like to find out more information, you can start your prevention journey by calling the genetic testing area at 859-301-5396.

Keep in mind, as part of this they also have nutrition programs and much more to focus on prevention at the new Cancer Center in Edgewood.

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Ask the Expert: How is precision medicine used in cancer prevention? - WKRC TV Cincinnati

Recommendation and review posted by Bethany Smith

Detect Lysosomal Storage Diseases program reduces barriers to genetic diagnosis through sponsored testing for lysosomal storage disorders, including GM2 gangliosidosis

Behind the Seizure program can help accelerate genetic epilepsy diagnosis in children experiencing unprovoked seizures

Taysha Gene Therapies Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced a partnership with Invitae, a leading medical genetics company, to support Invitaes Detect Lysosomal Storage Diseases (Detect LSDs) and Behind the Seizure programs. The Detect LSDs program enables the rapid diagnosis of lysosomal storage disorders (LSDs), including GM2 gangliosidosis (also known as Tay-Sachs and Sandhoff disease). The Behind the Seizure program is an innovative, cross-company collaboration that supports faster diagnosis for children with epilepsy. The Behind the Seizure program will also support patient identification across Tayshas broad pipeline of gene therapies for which a number of indications have an underlying seizure phenotype.

"Through both initiatives, we are supporting the rapid identification of patients with debilitating diseases, allowing them to gain access to earlier therapeutic interventions. For LSDs, there are more than 50 different disorders with overlapping symptoms, making misdiagnosis common," said RA Session II, Tayshas President, CEO and Founder. "Likewise, more than 50% of epilepsies have a genetic basis. When a patient presents with seizures, genetic testing may help identify more than 100 underlying, often rare conditions. We are proud to support these initiatives to help patients gain timely access to natural history studies, clinical trials, and ultimately disease-modifying therapies."

Eligible individuals suspected of having an LSD or epilepsy will gain access to genetic testing and counseling at no charge through these programs. The Detect LSDs program will help identify individuals who are eligible for Tayshas study evaluating TSHA-101 in patients with GM2 gangliosidosis, expected to enter the clinic later this year. The Behind the Seizure program will enable patient identification across Tayshas broad pipeline of indications, some of which have an underlying seizure phenotype, and rapid enrollment into natural history studies and clinical trials.

Story continues

"Increasing access to genetic testing can support earlier diagnosis of neurodegenerative diseases, which in turn enables clinicians to provide precision therapies sooner and better overall outcomes," said Robert Nussbaum, M.D., Chief Medical Officer of Invitae. "These unique, cross-company collaborations have been shown to help increase access to testing and reduce time to diagnosis. We are pleased Taysha has joined us in helping increase access to testing for children impacted by neurodegenerative conditions."

Additional details, as well as terms and conditions of the Detect LSDs program, can be found at https://www.invitae.com/en/detectLSDs/. To learn more about the Behind the Seizure program, please visit https://www.invitae.com/en/behindtheseizure/.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.

About Invitae

Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website at invitae.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the conduct or timing of our partnership with Invitae and our planned clinical trial of TSHA-101 for the treatment of GM2 gangliosidosis, the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our prospectus dated September 23, 2020, as filed with the Securities and Exchange Commission ("SEC") on September 24, 2020, pursuant to Rule 424(b) under the Securities Act of 1933, as amended, which is available on the SECs website at http://www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201006005450/en/

Contacts

Company Contact: Niren Shah, PharmD, MBATaysha Gene TherapiesNshah@tayshagtx.com

Media Contact: Carolyn HawleyCanale Communicationscarolyn.hawley@canalecomm.com

Link:
Taysha Gene Therapies Partners with Invitae to Enable Rapid Access to Genetic Testing and Earlier Diagnosis of Patients with CNS Disease for Rare and...

Recommendation and review posted by Bethany Smith