Archive for the ‘Hormone Physician’ Category

A recent article published by Catholic news outlet LifeSiteNews alleged that the drugs used to treat gender dysphoria in some transgender children are linked to thousands of deaths.

The story went viral on right-wing news websites such as the Christian Post and the Daily Wire. According to CrowdTangle, a social media metric platform, these posts including shares by Daily Wire founder Ben Shapiro and commentator Matt Walsh are currently some of the top performing LGBTQ-related content on Facebook and Twitter.

The problem is: the thousands of people who die while taking these drugs are likely the terminally ill cancer patients who receive hormone blockers to fight hormone-sensitive cancers, like prostate cancer, according to experts.

Joshua Safer, a professor of medicine and the executive director of the Mt. Sinai Center for Transgender Medicine and Surgery, said Lupron, or leoprolide acetate, is used for treating precocious puberty, infertility and certain types of cancer, particularly prostate cancer.

Prostate cancer is worsened by the presence of certain hormones, so people fighting this disease are sometimes given hormone blockers puberty blockers to slow the cancers progression.

I think all they did is went into the FDA database and looked at reports, Safer said. Theres no study here, thats just a big smorgasbord of reports and so the problem with that is you don't even know that those deaths are connected to the agent they are reported to be connected to.

Much more likely, Safer said, is that the 6,370 deaths over four decades the FDA lists as connected to this drug are in terminally ill cancer patients who are prescribed Lupron as a palliative, not curative, treatment.

They wouldnt even be using it if they werent at risk of death, Safer said of the drugs use in prostate cancer patients.

The American Cancer Association estimates that there are roughly 30,000 deaths from prostate cancer annually in the United States.

The original LifeSiteNews story, which was modified after initial publication, said that the UKs National Health Service is investigating these drugs. A spokesperson for the NHS told NBC News that no special review is being launched into the use of this drug for the treatment of gender dysphoria and noted that all transgender health care services are regularly reviewed.

The NHS own guidelines for the treatment of children with gender dysphoria notes that psychological support and puberty suppression have both been shown to be associated with an improved global psychosocial functioning in youth. Both interventions may be considered effective in the clinical care of psychosocial functioning difficulties in adolescents with [gender dysphoria].

Every decision in medicine involves weighing risks and benefits, said Jack Turban, a resident physician in psychiatry who researches transgender youth at the Massachusetts General Hospital. Turban said that for trans youth, the potential mental health benefits of pubertal suppression far outweigh any potential risks.

Allowing puberty to progress is not a neutral decision for many transgender youth, Turban said. Many of these youth see their mental health drastically deteriorate as puberty starts to progress. While pubertal suppression is reversible, puberty itself is not.

Heron Greenesmith, a senior research analyst at Political Research Associates, tracks anti-transgender rhetoric in mainstream media and said the article exemplifies LifeSiteNews' membership in the Christian-right anti-transgender disinformation ecosystem.

LifeSite platforms the small number of anti-trans researchers, academics, and right-wing professional associations, giving their work a veneer of scientific validity, Greenesmith said. Advocacy organizations can then cite LifeSite, in turn giving their advocacy a veneer of journalistic independence."

Gillian Branstetter, a spokesperson for the National Center for Transgender Equality, said the publication of this article was dangerous.

Transgender youth face a public health crisis in this country, and families must already fight through significant barriers to accessing adequate health care, Branstetter wrote. Much like vaccines, I would encourage news outlets and social media to be extremely sensitive to the risks posed by lies about transition-related health care promoted by bad actors.

NBC News has reached out to LifeSiteNews for comment.

Follow NBC Out on Twitter, Facebook & Instagram

Tim Fitzsimons reports on LGBTQ news for NBC Out.

Read the original post:
A viral fake news story linked trans health care to 'thousands' of deaths - NBCNews.com

Sgt. Anna Lange filed a lawsuit against the county where she works in Georgia for refusing to allow her health insurance plan to cover gender-affirmation surgery. Audra Melton for NPR hide caption

Sgt. Anna Lange filed a lawsuit against the county where she works in Georgia for refusing to allow her health insurance plan to cover gender-affirmation surgery.

A sheriff's deputy in Perry, Ga., filed a lawsuit in federal court Wednesday against the county where she works for refusing to allow her health insurance plan to cover her gender-affirmation surgery.

Sgt. Anna Lange came out as transgender in 2017, after working in the Houston County Sheriff's Office since 2006. She has taken hormone therapy and outwardly changed her appearance over the past three years to treat gender dysphoria, the distress resulting from the mismatch between her sex assigned at birth and her gender identity.

Her next step was going to be gender-affirmation surgery, but that plan came to a halt when, as NPR previously reported, her insurance provider denied coverage for the procedure, based on an exclusion specified by her employer.

Now, Lange is suing the Houston County Board of Commissioners to remove that exclusion. Early on Wednesday, she and her lawyer, Noah Lewis of the Transgender Legal Defense and Education Fund, filed suit in U.S. District Court in Macon, Ga., alleging unlawful discrimination under federal and state equal protection clauses, Title VII of the Civil Rights Act and the Americans with Disabilities Act.

County officials did not return calls for comment.

Lange's case is the latest in the U.S. to challenge the exclusion of transgender care from state and municipal employee insurance plans and could create legal precedents for cases across the South.

Other transgender people have won similar fights elsewhere. The managers of Wisconsin's state employee insurance program excluded transgender employees from coverage but later reversed that decision. Separately, two University of Wisconsin employees sued the state and won. Another lawsuit successfully challenged transgender exclusions in Wisconsin's Medicaid plan.

Earlier this year, Jesse Vroegh, a transgender employee of the Iowa Department of Corrections, won a lawsuit he'd filed after being denied coverage by his employer's health insurance plan.

And in Georgia, the state's university system recently settled an insurance exclusion claim for gender-affirmation surgery filed by Skyler Jay, known for his appearance on the Netflix series Queer Eye. In addition to changing its employee health plan to be inclusive of transgender care, the university system paid Jay $100,000 in damages.

"The university clearly agreed that it was discrimination," says Lange's attorney, Lewis, who also represented Jay. "That's why they wanted to do the right thing and remove the exclusion."

In 2011, another Georgia case, Glenn v. Brumby, set the legal precedent protecting transgender people from employment discrimination. However, that case did not address discrimination in employee benefits and, like Jay's case, many that deal with benefits have been settled out of court, according to Lewis.

The Affordable Care Act, which took effect in 2014, specifically prohibits discrimination by health insurance issuers on the basis of gender identity, and Title VII of the Civil Rights Act also has been interpreted to prohibit such discrimination.

Despite broad legal consensus that transgender insurance exclusions are unlawful, state and local governments continue to pursue expensive legal fights to preserve them. The issue remains contentious for many social conservatives.

"Ultimately, what's happening is that, politically, I presume they think it's unpopular or they think they have to defend" the law or regulation, says John Knight, an attorney with the American Civil Liberties Union.

Resisting paying for such care can be more expensive than providing it. Not including the costs of state attorneys' salaries or appeals, Wisconsin's litigation against the employees of its university system cost the state more than $845,000, while Iowa's cost about $125,000.

Furthermore, the cost of managing untreated gender dysphoria can outweigh the costs of providing transgender-inclusive health care, according to a 2015 study.

"Given the small number of people who actually need this kind of care and the large pool of people, it will have absolutely no impact on the total cost of insurance for any state," Knight says.

While settlements such as Jay's may be good for individuals, they do not require institutions to admit wrongdoing and do not result in a legal precedent that other, lower courts must follow.

"The court doesn't have to look at that settlement and say, 'Oh, this was discrimination,' " Lewis says. "Transgender workers in the South are being left behind, which is why we're seeking a court ruling to clearly establish that this conduct is unlawful throughout the South."

Lange's suit argues that the county's exclusion of transgender health care from coverage was deliberate: In documents Lewis obtained under the Freedom of Information Act, Kenneth Carter, the county's personnel director, opted out of compliance with Section 1557 of the Affordable Care Act, which prohibits discrimination by health programs on the basis of gender identity.

"Houston County will be responsible for any penalties that result if the plan is determined to be noncompliant," he wrote in a letter to a representative of Anthem Blue Cross and Blue Shield, which administers the plan.

Carter did not return calls for comment.

Lange's case could end up before the 11th U.S. Circuit Court of Appeals, yielding a decision that could influence other courts in Alabama, Florida and Georgia. And, if the ruling is in Lange's favor, Lewis says, that would signal that transgender exclusions should be removed nationwide.

Lange's suit argues that the county's exclusion of transgender health care from coverage was deliberate. Audra Melton for NPR hide caption

Lange's suit argues that the county's exclusion of transgender health care from coverage was deliberate.

In its next term, the U.S. Supreme Court will hear three cases that will determine workplace protections of LGBTQ individuals, including one case involving a transgender woman.

Lange says she merely wants the same protections everyone else has. The co-workers with whom she shares a health plan might have used "something on the policy that I may never use or need, but it's covered," she says. "When it's finally something that I need that one of my co-workers will probably never use or need, mine's excluded. And that's just not fair."

Keren Landman, a practicing physician and writer based in Atlanta, covers topics in medicine and public health. Kaiser Health News is a nonprofit, editorially independent program of the Kaiser Family Foundation. KHN is not affiliated with Kaiser Permanente.

Visit link:
Access To Transgender-Related Health Coverage Is The Focus Of A Georgia Lawsuit : Shots - Health News - NPR

A man who received chimeric antigen receptor-T cell therapy shares his firsthand account.

Backer received a diagnosis of diffuse large B-cell lymphoma (DLBCL). It is the most common type of non-Hodgkin lymphoma, which affects nearly 75,000 people mostly men in the United States each year.

Despite multiple rounds of chemotherapy and a stem cell transplant, Backers disease kept relapsing. Then he participated in a clinical trial involving chimeric antigen receptor (CAR)-T cell therapy, which has left him cancer-free for almost three years. With this type of immunotherapy, a patients T cells are removed, altered in a lab and then reinfused in the hope that they will attack cancer cells.

Dr. Frederick L. Locke, a medical oncologist at Moffitt Cancer Center in Tampa, Florida, isco-lead investigator of the pivotal ZUMA-1 trial, which led to the Food and Drug Administration (FDA) approval of the second available CAR-T cell therapy, Yescarta (axicabtagene ciloleucel). During the National Comprehensive Cancer Network 2019 Annual Conference, Locke, Backer and Alix Beaupierre, a transplant nurse coordinator, took a 360-degree look at CAR-T cell therapy.

LIMITED OPTIONSOutcomes in refractory aggressive non-Hodgkin lymphoma are poor, Locke explained. Patientsare often treated upfront with combination chemotherapy, as Backer was. He initially wenton a chemotherapy regimen commonly known as R-CHOP Rituxan (rituximab), cyclophospha- mide, Adriamycin (doxorubicin), Oncovin (vincris- tine) and prednisone. He achieved a complete remission and went back to work.

We can cure up to about 60% of patients with initial chemotherapy, and thats pretty remarkable, Locke said. Unfortunately, 40% of patients either dont respond to chemotherapy or progress.

Backer was among that 40%. He relapsed about a year later and started on a new chemotherapy regimen with a planned autologous stem cell transplant, which would involve removing his own stem cells and later putting them back into his body to help fight the cancer. This treatment plan cures only about 5% of patients, Locke said. Prior to CAR-T cell therapy, more chemotherapy would have been next.

In the United States, two CAR-T therapies are available to patients with certain types of cancer. The first, Kymriah (tisagenlecleucel), was approved in August 2017 for patients up to 25 years old who have acute lymphoblastic leukemia that relapsed or did not go into remission with other treatments. Two months later, the FDA approved Yescarta to treat adult patients with certain types of large B-cell lymphoma who have not responded to or relapsed after at least two other kinds of treatment.In patients with DLBCL, durable responses the length of time that a partial or complete response is observed because of treatment have been seen in 40% of patients who received CAR-T cell therapy. We think we can cure about 15% of people, Locke said. We need these patients referred and referred early.

A NUCLEAR BOMBBacker first read about CAR-T cell therapy on clinicaltrials.gov, an online registry of all clinical trials that anyone can access to see what might be enrolling participants. Im the typeof person who needs a plan A and a plan B, Backer said.I received a plan A, but the plan B in the case of the transplant failing was not encouraging.

He reached out to Moffitt Cancer Center Tampa is not far from where he lived in Orlando, Florida to see if he was eligible. He wasnt. In December 2015, Backer went ahead with the stem cell transplant. A few months later,he again relapsed with growths all over his body butthis made his participation in the ZUMA-1 clinical trial possible. Being a participant in a clinical trial is scary and daunting at the same time, he said. I remember sitting there with the transplant coordinator and they handed me a 27-page consent form, and I could barely read page one. Ijust wanted to sign. I was ready to sign anything right then and there.

Although potentially curative, CAR-T cell therapy is not without risk. Patients can develop two serious side effects. Cytokine release syndrome, caused by a large, rapid release of cytokines (small proteins importantin cell signaling) into the blood from immune cells affected by the immunotherapy, can be life-threatening. Neurological events, such as confusion, tremor and seizures, can also occur.

Despite lengthy discussions with his medical teamat Moffitt and reading the consent form, Backer said,he wasnt fully prepared for the coming side effects and recovery when he went forward with CAR-T therapy in June 2016. Thats when the nuclear bomb set off, he said. Within 12 hours of receiving the infusion, he experienced severe chills, violent shaking and a high fever, and also felt certain he was experiencing side effects that were affecting his brain.

About two days after Backer received the reinfusedT cells, the infectious disease team rushed him in for a CT scan. They found no infection and no signs of the cancer.

For me, it was a miracle treatment, Backer said.

Locke has been following patients enrolled in ZUMA-1 for more than two years and said that half are still alive.

BEING PREPAREDBacker admitted that going in with a full understanding of CAR-T cell therapy would have made the experience dramatically different.

After seeing patients and their loved ones in distress, care providers at Moffitt Cancer Center learned to smooth the process, Beaupierre said. For instance, the 27-page document has been broken down into one-page educational handouts and shorter consent forms. The team also created a flow sheet and that grew to a detailed patient calendar. All CAR-T therapy recipients also now have a dedicated nurse and social worker.

In addition to those resources, Backer said, peer-to-peer support would be helpful.

As CAR-T cell therapy continues to evolve and be explored in the treatment of other cancer types, experts are learning more about how it works and how to improve the process.

For Backer, quality of life has changed a bit. Initially, he received blood and platelet transfusions every two weeks for several months following CAR-T cell therapy. Although he is back to work full time, he runs the risk of being exposed to other diseases and viruses. Its always at the back of my mind, he said. I wear a mask and goggles at work but still get sick.

He spends his free time hiking and fishing and feels blessed to still be alive. It worked out for me, and here we are 33 months into this thing, Backer said.

Follow this link:
Walking in His Shoes - Curetoday.com

Men with breast cancer had a higher mortality rate when compared with women with breast cancer, reported a cohort study recently published in JAMA Oncology. This overall finding aligns with what previous studies have found and highlight the need for better awareness about male breast cancer.

Most people with breast cancer are found to have breast cancer because they have a lump in their breast, and you would think that in men it would be easier to find a lump in the breast, saidJoanne Mortimer, MD, director of City of Hopes Womens Cancer Programs, who was not involved with the study, during an interview with CancerNetwork. Unfortunately, people's suspicion about what's going on in the breast of a man is not the same as a woman.

The study was conducted using the National Cancer Database, and 1,816,733 patients with a breast cancer diagnosis between January 1, 2004, and December 31, 2014 were identified. The totals were 1,800,708 women and 16,025 men.

Men with breast cancer had a significantly worse overall survival (OS) rate (45.8% vs 60.4%; P < .001), 3-year OS rate (86.4% vs 91.7%; P < .001), and 5-year OS rate (77.6% vs 86.4%; P < .001) compared with women with breast cancer, according to the data.

Even when men were diagnosed at the same disease stage as women, their survival outcomes were still inferior. For the 5-year OS rate, men had worse survival than women at stage I (87.8% vs 92.5%; P < .001), stage II (78.9% vs 85.9%; P < .001), stage III (63.3% vs 70.1%; P < .001), and stage IV disease (21.4% vs 25.1%; P = .007).

Several factors were associated with a higher mortality rate among men, including age, clinical characteristics, treatment received, access to care, and race/ethnicity.

However, when all these factors were controlled for, men still have worse survival. The study authors pointed out that this suggests that other factors, particularly additional biological attributes, treatment compliance, and lifestyle factors, should be identified to help in eliminating this disparity.

Clinical and treatment characteristics were the primary factors linked to worse survival, they added.

Clinical characteristics and undertreatments were associated with 63.3% of the excess mortality among male patients, the authors wrote.

The cohort study also revealed that a higher proportion of men were diagnosed with more advanced disease, yet less likely to receive standard treatment. For example, men with hormone receptor-positive breast cancer were less likely to receive adjuvant endocrine therapy compared with women.

These endocrine therapies are very effective at increasing the cure rate of breast cancer, Mortimer. It's unfortunate that these men did not get endocrine therapy as part of their treatment.

In fact, Don Hoffman, a male breast cancer patient who Mortimer helped care for, exemplifies the importance of early detection and proper treatment for men.

Man or woman, early detection is a lifesaver, said Hoffman. He noticed the nipple and areola on his left breast were flatter than usual and had his breast checked by his primary care physician. A mammogram showed a small mass, which was treated. My early detection probably made me a better candidate to live longer.

To Hoffman, one reason why men may be diagnosed later on, when outcomes are worse, is a mans attitude toward seeking medical care. A man's attitude is, Oh, I can tough this out, this is not a big deal, Hoffman said. I think that mindset works against men.

Disclosures:

Wang F, Shu X, Meszoely I. Overall Mortality After Diagnosis of Breast Cancer in Men vs Women. JAMA Oncol. Published online September 19, 2019.

See the rest here:
Men with Breast Cancer Have Worse Mortality, Highlight Need for Better Awareness - Cancer Network

BARCELONA, Spain Final overall survival (OS) results from the MONARCH 2 and MONALEESA-3 trials show consistent OS benefits with the cyclin-dependent kinase 4/6(CDK4/6) inhibitors abemaciclib (Verzenio, Lilly) and ribociclib (Kisqali, Novartis). The new data establish the foundation for adding these drugs to endocrine therapy in the treatment of patients with hormone receptor positive, human epidermal receptor negative (HR+/HER2-) advanced breast cancer (ABC).

The new results were presented here at the European Society of Medical Oncology (ESMO) 2019 Annual Meeting and were published online September 29 in JAMA Oncology.

The results from MONARCH 2 show that after a median follow-up of approximately 4 years (47.7 months), patients with HR+/HER- ABC lived significantly longer with the combination of abemaciclib and fulvestrant. Median OS was 46.7 months with the combination and 37.3 months with fulvestrant alone (hazard ratio [HR], 0.757; 95% confidence interval [CI], 0.606 0.945; P = .0137).

This is a statistically significant and clinically meaningful improvement in OS, commented first author George Sledge, MD, Stanford University School of Medicine, California.

"The main take-home message from this study and from other similar studies is that CDK4/6 inhibitors significantly prolong the time patients remain in remission and significantly improve overall survival. Therefore, it is very reasonable to think of these as standard-of-care options for patients with metastatic breast cancer," Sledge commented in an ESMO statement.

A similar benefit was seen with the combination of ribociclib and fulvestrant in MONALEESA-3. After a median follow-up of 39.4 months, median OS was not reached with the combination of ribociclib and fulvestrant; it was 40.0 months for patients who received fulvestrant alone (HR, 0.724; 95% CI, 0.568 0.924; P = .00455).

"This is a significant, practice-changing report, in that we are now saying that patients with advanced breast cancer will have an overall survival benefit if they get the CDK4/6 inhibitor ribociclib up front at the time of their recurrence, even if they have not had any prior endocrine therapy at the time of presenting with metastatic disease," commented first author Dennis J. Slamon, MD, PhD, from the David Geffen School of Medicine at the University of California, Los Angeles.

Commenting for ESMO, Matteo Lambertini, MD, of the IRCCS Policlinico San Martino Hospital, University of Genoa, Italy, said, "Uniquely, MONALEESA-3 is the only trial with a CDK4/6 inhibitor to include patients with endocrine-sensitive as well as those with endocrine-resistant disease. This is the first time we have seen improved overall survival with a combination of a CDK4/6 inhibitor plus fulvestrant in first line."

The two trials had different patients populations: MONARCH 2 enrolled premenopausal, perimenopausal, and postmenopausal patients, whereas MONALEESA-3 enrolled only postmenopausal patients. However, a separate study (MONALEESA-7, whih included 1400 patients) reported positive OS results for premenopausal women with HR+/HER2- ABC who received ribociclib and fulvestrant. Slamon said that together, the two MONALESSA trials demonstrated a consistent and meaningful benefit with multiple endocrine therapy partners regardless of menopausal status.

"These are clinically highly meaningful data and are a game changer," commented ESMO expert Nadia Harbeck, MD, of the Breast Center at Ludwig Maximillians University in Munich, Germany. She was speaking at a press briefing at which the results from both trials had been highlighted.

These data will ensure that CDK4/6 inhibitors become the standard of care in treating patients with HR+/HER- ABC and should be used first line because they substantially improve patient outcomes compared with antihormonal treatment alone, Harbeck commented.

"We can never guarantee that patients will come back for second-line therapy. We should give the best drugs first," she said.

Harbeck was optimistic that, in light of the significant OS benefits, costs of these drugs will be reimbursed and that the drugs will be available for those who need it.

Besides abemaciclib and ribociclib, palbociclib (Ibrance, Pfizer) in combination with endocrine-based therapy is also available for use in the first-line and second-line settings of ABC. However, the OS data for this agent were not statistically significant.

At the press conference, questions were raised as to whether the mechanisms of resistance of the three available CDK4/6 inhibitors overlapped, whether they can be given in sequence, and what would dictate the use of one drug over another.

Slamon indicated that although in clinical practice, physicians have been using CDK4/6 inhibitors in sequence, cross-resistance mechanisms should preclude their being used in sequence after resistance develops.

Sledge noted that not enough patients have been followed for long enough and warned that cross-trial comparisons should not be made. In addition, he pointed out that the HRs from progression-free survival (PFS) and OS are impressive and are similar in the studies. "Primary efficacy does not provide any information on the superiority of one drug over the other," he said, but he suggested that the different toxicity profiles may favor one over the other.

Medscape Medical News asked Laura M. Spring, MD, a breast cancer expert from the Massachusetts General Cancer Center in Boston, Massachusetts, for her views on these data and how she integrates CDK4/6 inhibitors in her clinical practice.

Spring explained that CDK4/6 inhibitors are now given in conjunction with endocrine therapy for HR+/HER2- ABC unless there are toxicity concerns for patients. As an example, she indicated that an older patient with only osseous disease who expresses concerns about the side effects of adding a second agent could be given CDK4/6 in the second line after progression occurs with endocrine monotherapy.

The three CDK4/6 inhibitors are similar in efficacy, but they have distinct side effect profiles, she observed. The incidence of neutropenia is higher with ribociclib and palbociclib, whereas diarrhea is a concern with abemaciclib. QTc prolongation is a possible concern with ribociclib, and patients have to be monitored routinely with electrocardiography, Spring noted.

"That is why choosing one over another may be dictated by the other medicines patients are taking as well as their comorbidities," she said. If a patient is taking medication for QTc prolongation, she would be less likely to receive ribociclib, whereas a patient with gastrointestinal problems would be less likely to receive abemaciclib, she said.

All three agents have shown similar PFS benefit in their respective trials. However, the OS benefit now reported with ribociclib and abemaciclib was statistically significant, whereas that reported for palbociclib was not, although there was a trend showing better survival. That data come from the PALOMA-3 trial, which compared the combination of palbociclib and fulvestrant with fulvestrant for patients whose disease had progressed after initial endocrine therapy.

Despite that, patients who received the combination were at a significantly 28% reduced risk for death or progression, Spring observed.

She suggested that the lack of statistical significance was a detail that would most likely be significant only to a purist, owing to the fact that the benefit of these agents as a class is established.

She also noted that OS was the secondary endpoint for all three studies, that PALOMA-3 was not powered to show significance for OS, and that longer follow-up may be needed.

In addition, the patients in PALOMA-3 were heavily pretreated, which is likely to affect clinical outcomes.

Several experts cautioned against making cross-trial comparisons. "The three studies have key eligibility differences, and cross-trial comparisons are not warranted," Spring said.

Spring told Medscape Medical News that, as a standard of care, a physician in the United States can order any of the three agents, depending on the type of insurance coverage a patient carries. The OS data may provide a boost for abemaciclib and ribociclib, she suggested.

Sledge added that at least in the United States, indications overlap for all three CDK4/6 inhibitors and all are already approved in the second-line setting; thus, reimbursement is not likely to change much. "I think it is more likely that the docs will change. When you have an OS advantage, that changes how we feel about a drug," Sledge told Medscape Medical News.

However, Spring pointed out that palbociclib was the first CDK4/6 inhibitor to be approved, and many physicians have a greater "comfort level" with its use.

Ease of dosing and ease of dose reduction are also factors to take into consideration, she added. Abemaciclib is taken twice daily on a continuous dosing schedule, whereas ribociclib and palbociclib are given once daily on a 3-week-on, 1-week-off schedule. Because of its packaging, it is easier to reduce the dose of ribociclib without writing a new prescription, she observed.

"In prescribing CDK4/6 inhibitors to patients, it is important to discuss with them the differences between the agents, which in large measure are minor," Spring said. "But sometimes a small difference makes a big difference to a patient," she added. Some patients may prefer continuous dosing with abemaciclib, whereas others may discount that factor because the drug has to be taken twice daily, she said.

Spring recommends sequencing with another CDK4/6 agent, ideally only in the context of a clinical trial. In MONARCH 2, Sledge reported that subsequent CDK4/6 therapy was provided to 5.8% of patients who experienced disease progression with abemaciclib and fulvestrant.

MONARCH 2 randomized pre-, peri-, and postmenopausal patients with HR+/HER- ABC to receive abemaciclib twice daily on a continuous dosing schedule in addition to fulvestrant (n = 446) or fulvestrant alone (n = 223). These patients were endocrine-therapy resistant but had received no more than one prior endocrine therapy, and they had received no chemotherapy for ABC.

In addition to the new results for OS, reported above, Sledge also presented updated data for PFS (the primary endpoint). Median PFS was 16.9 months with the abemaciclib combination and 9.3 months with fulvestrant. With a hazard ratio (HR) of 0.536, patients who received the abemaciclib combination were at a significantly 44% decreased risk for progression or death (P <0.0001). Three-year PFS was nearly three times higher with the abemaciclib combination: 29.9% vs 10.1% for patients who received fulvestrant.

"At three years, three times as many patients on the combination remain progression free [compared those who received fulvestrant]," Sledge said.

Time to initiation of chemotherapy was an exploratory endpoint of the study. The abemaciclib combination was associated with a 60% delay in the time to initiation of chemotherapy. Median time to initiation was 22.1 months for fulvestrant, vs 50.2 months for the combination (HR: 0.625; P <0.0001).

Sledge reported that there were no additional safety signals and that the safety profile of abemaciclib was consistent with that reported in the primary analysis.

MONALEESA-3 randomly assigned 726 patients with HR+/HER2- ABC to receive oral ribociclib on a 3-weeks-on, 1-week-off dosing schedule in addition to fulvestrant (n = 484) or fulvestrant alone (n = 242). Slamon noted that approximately 50% of patients received these therapies in the first-line setting.

Updated data for the primary endpoint of PFS showed that median PFS was significantly longer for patients who received the combination (20.6 months vs 12.8 months for fulvestrant; HR, 0.587).

In addition to the median OS results reported above, Slamon reported that landmark 3-year OS was 67.0% for patients who received the combination and 58.2% for those who received fulvestrant. In this second prespecified analysis, the P value crossed the prespecified boundary for establishing superior efficacy, Slamon observed. The OS benefits were seen across all subsets of patients, including those distinguished on the basis of site of metastases and line of therapy.

"There was a significant delay in time to first chemotherapy," Slamon observed. The median time to first chemotherapy was not reached in patients who received the combination; it was 29.5 months for those who received fulvestrant.

No new safety signals were observed. Slamon reported on the incidence of grade 3/4 adverse events of special interest with the combination (vs fulvestrant):

Neutropenia: 57.1% vs 0.8%

Hepatobiliary toxicity: 13.7% vs 5.8%

Pulmonary disorders: 0.2% vs 0% (no cases of grade 3/4 pneumonitis or interstitial lung disease were reported)

QTc prolongation: 3.1% vs 1.2% (no episodes of torsades de pointes were observed)

At the meeting, discussant Sibylle Loibl, MD, of the German Breast Group and Goethe University, Frankfurt am Main, Germany, provided some context for the new data.

She noted that each trial had slightly different patient populations. Importantly, patients in MONALEESA-3 were the least heavily pretreated, whereas those in PALOMA-3 were the most heavily pretreated. As the level of pretreatment increased across the trials, the median PFS also decreased, she noted. More heavily pretreated patients will also have a shorter median OS, she noted.

In summarizing the data, Loibl indicated that CDK4/6 inhibitors improved PFS in the first-line and second-line settings of metastatic breast cancer, which translates to an improvement in survival. Improvement in outcomes was seen irrespective of pretreatment, menopausal status, endocrine sensitivity, and site of metastases. A meta-analysis of all the CDK4/6 trials data will likely reveal potential differences in subgroups, she said.

Sledge reports relationships with Eli Lilly, Pfizer, Syndax, Symphogen, Verseau, and Tessa. Slamon reports relationships with Biomarin, Pfizer, Vertex, Lilly, and Novartis. Spring reports relationships with Novartis, Lumicell, Puma, Merck, and Tesaro. Loibl reports relationships with AbbVie, Amgen, AstraZeneca, Celgene, Eirgenix, Novartis, Pfizer, Puma; Roche, Samsung; Seattle Genetics, Teva, Vifor, Daiichi, Cepheid, Myriad, PRIME, and Chugai.

European Society for Medical Oncology (ESMO) 2019 Annual Meeting: Abstracts LBA6_PR (MONARCH 2), LBA7_PR (MONALESSA-3),presented September 29, 2019.

JAMA Oncol. Published online September 29, 2019. Full text

Follow Medscape on Facebook, Twitter, Instagram, and YouTube

Read the original:
Now With Survival Benefit, CDK4/6 Inhibitors in Breast Cancer - Medscape

Vasalgel is inching toward human trials, in part boosted by a $200,000 grant from the Male Contraceptive Initiative (MCI), a private non-profit that focuses on the development of non-hormonal methods.

Heather Vahdat, the executive director of MCI, anticipates that either Vasalgel or another product similar in scope, called Echo-VR, will be the first options supported by the MCI to reach the market some time in 10-plus years.

Vahdat tells Inverse that apart from those two potentials, theres a range of products in the very early stages of development that hold a lot of promise. The goal is to create a future where men have just as many options as women to establish what Vahdat describes as true contraceptive choice.

We are aiming for a contraceptive method mix that benefits everyone, so that partners can consider their future together or individuals can protect themselves, Vahdat explains.

But one concern is that a lack of cash could keep Vasalgel from ever being a real option. Vasalgel is being developed by the Parsemus Foundation a non-profit that takes on products pharmaceutical companies ignore. It collects donations but it usually takes pharmaceutical company-levels of cash to actually get a product to market. The National Institutes of Health is the largest domestic funder of male contraceptive research, while MCI is one of the largest funders globally. Theyve donated just over $2 million to various research programs since 2017, which, while impressive, is still a small amount in the world of pharmaceutical product development.

Back in the 1990s, pharmaceutical research and development for male contraception was an active space. But since then, Long explains, its been virtually abandoned.

The thought is that industry pulled away from male contraceptive development due to concerns that the market was already saturated with female methods, Long says. Moving into the male market, where the risk profile is uncertain, was too risky.

Follow this link:
A guide to the next 20 years of male birth control - Inverse

A joyful heart makes for good health; Despondency dries up the bones. Proverbs 17:22,

Ewings sarcomais a very rare type of canceroustumor that got its name from Dr. James Ewing, the physician who first described it almost exactly a century ago. It affects children through young adults mostly teens and can appear anywhere in the body, but it usually originates in the long bones of the arms and legs, the pelvis or the chest.

The cause of Ewing sarcoma is unknown, and it cant be prevented, but it arises from specific types of cells and it doesnt appear to be inherited. It grows in the bones or the soft tissue around the bones, such as cartilage or the nerves. Significant advanced in treatment, especially at an early stage, have improved survival rates, but when it spreads to distant organs by metastasis, it is very difficult to to treat. After finishing their course of treatment, patients need lifelong monitoring for potential late effects of intense chemotherapy and radiation, as it can return even years after treatment.

The symptoms include pain in the bone or elsewhere, swelling or tenderness near the affected area, unexplained tiredness, unintended weight loss, fragile bones and fever with no known cause.

But there is some hope. A study in mice conducted by researchers at the Weizmann Institute of Science in Rehovot shows that reducing a particular hormone signal keeps the cancer from growing and spreading. They have discovered molecular interactions underlying this kind of tumor and proposed a potential treatment, according to findings they just published in the journal Cell Reports.

Postdoctoral fellow Dr. Swati Srivastava in the laboratory of Prof. Yosef Yarden in the biological regulation department, together with colleagues, conducted research focusing on receptors for steroid hormones called glucocorticoids. These receptors are present in virtually all human cells, conveying hormonal messages related to stress, wakefulness and a host of other important functions.

But sometimes glucocorticoid receptors stimulate malignant growth. They do this by moving to the cell nucleus, where they physically interact and bind with transcription factors molecules that turn genes on or off. The researchers wanted to learn more about the role of these interactions in malignancy.

A highly sensitive protein interaction analysis suitable for living cells revealed previously unknown interactions: Once activated by hormones, glucocorticoid receptors were found to be binding in the cell nucleus to transcription factors of the E-twenty-six (ETS) family, forming together a physical complex. One of the transcription factors in the ETS family is known to drive the development of Ewing sarcoma; its gene fuses abnormally with another gene, creating an oncogene: a cancer-causing gene.

When the study turned up this link between the Ewing sarcoma oncogene and glucocorticoid receptors, the researchers set out to test a hypothesis: that these receptors boost the growth of Ewing sarcoma. A series of studies supplied evidence that this is indeed the case. Physical binding between glucocorticoid receptors and the protein made by this oncogene increased the growth and migration of Ewing sarcoma cells in a lab dish and gave an even stronger boost to the growth and spread of the sarcoma in laboratory mice.

The major medical significance of these findings is that they open the door to a new treatment option for Ewing sarcoma. When the researchers implanted human Ewing sarcoma cells into mice, the tumors grew much more slowly when the mice were treated with metyrapone, a drug that is approved for the treatment of adrenal insufficiency and works by reducing the synthesis of glucocorticoids.

In other experiments, also in mice, another drug, mifepristone which blocks the glucocorticoid receptor and is approved for other clinical applications prevented the metastasis of Ewing sarcoma via a major cancer cell dissemination route, from bone to the lungs. In contrast, when the researchers increased the activity of glucocorticoid receptors, the sarcomas grew and spread much faster.

The researchers also performed a genetic analysis of tumor samples from Ewings sarcoma patients and identified seven genes regulated by the glucocorticoid receptors that were expressed in higher-than-normal levels in patients with particularly lethal tumors.

These genes might serve as a genetic signature enabling a selection of patients for treatment: Those with upregulated signature genes are especially likely to benefit from treatment aimed at neutralizing glucocorticoid receptors. The signature genes may also help predict the course of the disease: Their increased expression may signal a poor prognosis; reduced expression, on the other hand, may signal better chances for survival.

If research in human patients confirms the studys findings, they may offer new hope to youngsters with this malignancy, especially in cases when the sarcoma has metastasized beyond the bone, the researchers said.

Our findings provide the basis for a personalized approach to the treatment of Ewing sarcoma, Srivastava concluded. The fact that the study made use of drugs that have already been approved for other uses should speed up the implementation of this approach.

Link:
Israeli Researcher Discovers a New Way to Block Bone Cancer in Children - Breaking Israel News

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented detailed results from the Phase III PROfound trial in 387 men with metastatic castration-resistant prostate cancer (mCRPC) who have a mutation in their homologous recombination repair (HRRm) genes and whose disease had progressed on prior treatment with new hormonal agent (NHA) treatments (e.g. abiraterone or enzalutamide).

The trial was designed to analyze men with HRRm genes in two cohorts: the primary endpoint was in those with mutations in BRCA1/2 or ATM genes and then, if LYNPARZA (olaparib) showed clinical benefit, a formal analysis was performed of the overall trial population of men with HRRm genes (BRCA1/2, ATM, CDK12 and 11 other HRRm genes; key secondary endpoint).

Results showed a statistically significant and clinically meaningful improvement with LYNPARZA in the primary endpoint of radiographic progression-free survival (rPFS), improving the time men with BRCA1/2- or ATM-mutated mCRPC lived without disease progression or death to a median of 7.4 months vs. 3.6 months for those treated with abiraterone or enzalutamide. LYNPARZA reduced the risk of disease progression or death by 66% (equal to a hazard ratio of 0.34) for these men.

The trial also met the key secondary endpoint of rPFS in the overall HRRm population, where LYNPARZA reduced the risk of disease progression or death by 51% (equal to a hazard ratio of 0.49) and improved rPFS to a median of 5.8 months vs. 3.5 months for abiraterone or enzalutamide.

The results were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology (ESMO) congress in Barcelona, Spain (Abstract #LBA12_PR).

Results also showed a trend at this interim analysis time point for improvement in overall survival (OS), another key secondary endpoint, in the two groups. LYNPARZA extended OS to 18.5 months vs. 15.1 months for abiraterone or enzalutamide in men with BRCA1/2- or ATM-mutated tumors, despite that at this interim analysis 81% of patients on NHA crossed over to LYNPARZA at progression. A similar trend in OS was observed at this interim analysis in the overall HRRm population with a median of 17.5 months OS for men treated with LYNPARZA vs. 14.3 months for abiraterone or enzalutamide (analysis at 41% data maturity).

Jos Baselga, Executive Vice President, Oncology R&D, said: Results from PROfound demonstrate that, in addition to providing substantial benefit as a precision medicine for men with metastatic castration-resistant prostate cancer with BRCA-mutated tumors, LYNPARZA is effective beyond just BRCA in tumors with mutations in other genes associated with homologous recombination repair. PROfound validates the concept of PARP sensitivity across multiple genes associated with homologous recombination repair in this disease and marks the first positive Phase III trial using a molecular biomarker to identify men for targeted treatment for metastatic castration-resistant prostate cancer. We are working with global health authorities to bring LYNPARZA to these patients as quickly as possible.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, said: The results from the Phase III PROfound trial are a testament to Merck and AstraZenecas lasting commitment to patients with cancer. The trial met the primary endpoint in men with metastatic castration-resistant prostate cancer that progressed on prior hormonal therapy, a notoriously difficult-to-treat disease. The benefit seen in patients beyond just those with BRCA mutations underscores the potential value of genomic testing in prostate cancer.

Maha Hussain, one of the principal investigators of the PROfound trial and Deputy Director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, said: We have seen advances in the treatment over the last 15 years for men with metastatic castration-resistant prostate cancer. However, to date treatments for this state of disease continue to use one size fits all approaches overlooking the genomic make-up of the tumor and how it could inform treatment decisions to better personalize care and impact outcomes. I am thrilled by the PROfound results and LYNPARZAs clinically meaningful benefit which offers the potential of a molecularly targeted treatment for this patient population with advanced disease. I am confident we are now entering a new era of personalized care and precision medicine for metastatic castration-resistant prostate cancer.

Summary of resultsi

Cohort A

(BRCA1/2 or ATM)

Cohort A+B ii

(Overall HRRm)

LYNPARZA

n=162

pcNHA

n=83

LYNPARZA

n=256

pcNHA

n=131

rPFS

Median, months

7.4

3.6

5.8

3.5

% progression-free at 6 months

59.8

22.6

49.7

23.7

% progression-free at 12 months

28.1

9.4

22.1

13.5

Hazard ratio (95% CI)

0.34 (0.25-0.47)

0.49 (0.38-0.63)

p-value

<0.0001

<0.0001

Confirmed ORR

Patients with response (%)

33.3

2.3

21.7

4.5

Odds ratio (95% CI)

20.86 (4.18-379.18)

5.93 (2.01-25.40)

p-value

<0.0001

0.0006 (nominal)

Time to pain progression iii

Median, months

NR

9.92

Hazard ratio (95% CI)

0.44 (0.22-0.91)

p-value

0.0192

OS (interim) iv

Median, months

18.5

15.1

17.5

14.3

Hazard ratio (95% CI)

0.64 (0.43-0.97)

0.67 (0.49-0.93)

p-value

0.0173

0.0063 (nominal)

NR, not reached; ORR, objective response rate; pc, physicians choice i Assessed by blinded independent central review (BICR) ii Cohort B included patients with any 1 of 12 other HRR mutations iii Time to pain progression in Cohort A was a key secondary endpoint included in the formal hierarchy iv Interim analysis was done at 38% (Cohort A) and 41% (Cohort A+B) data maturity; Alpha spend at interim was 0.01; statistical significance not reached

The safety and tolerability profile of LYNPARZA in the PROfound trial was in line with that observed in prior clinical trials. The most common adverse events (AEs) 20% were anemia (47%), nausea (41%), fatigue/asthenia (41%), decreased appetite (30%) and diarrhea (21%). Grade 3 or above AEs were anemia (22%), pulmonary embolism (4%), fatigue/asthenia (3%), vomiting (2%), dyspnea (2%), urinary tract infection (2%), decreased appetite (1%), diarrhea (1%) and back pain (1%). 16% of patients on LYNPARZA discontinued treatment due to AEs.

AstraZeneca and Merck are also exploring additional trials in prostate cancer, including the ongoing Phase III PROpel trial, testing LYNPARZA as a 1st-line therapy in mCRPC, in combination with abiraterone.

LYNPARZA is currently approved for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is approved as 1st-line maintenance treatment in BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy. For 1st-line maintenance in advanced ovarian cancer and the metastatic breast cancer setting, physicians should select patients for therapy based on an FDA-approved companion diagnostic. LYNPARZA is not approved in metastatic pancreatic cancer, but an application is currently under regulatory review.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

ADVERSE REACTIONSFirst-Line Maintenance BRCAm Advanced Ovarian Cancer

The rest is here:
LYNPARZA (olaparib) More Than Doubled the Time Without Radiographic Disease Progression in Patients With BRCA1/2- or ATM-Mutated Metastatic...

Since children were once given radium candy and laudanum, a medication containing opium, that a drug administered to kids could be dangerous is not unprecedented. And now, worry critics, a puberty-blocking medication prescribed for children misidentified as transgender may also be imperiling the young.

As the Christian Postreports, Between 2012 and June 30 of this year, the FDA documented over 40,764 adverse reactionssuffered by patients who took leuprolide acetate (Lupron), which is used as a hormone blocker. More than 25,500 reactions logged from 2014-2019 were considered serious, including 6,370 deaths.

Adverse complications related to its use include breast disorders, malignant neoplasms, and psychiatric and nervous disorders, the Post also informs.

Lupron and other drugs in its class significantly alters the hormone levels in the body and has been documented to contribute to blood clots and other cardiovascular complications, as well as brittle bones and faulty joints, the site continues.

Note, however, that Lupron is said to have at least two legitimate applications (most every drug has its place), the first being halting precocious puberty.

The second application adds perspective to this story. As American Thinker writes, an NBC News piece debunks quite a bit of the Lupron bad press, probably accurately, noting that the drugs in question are often used on terminally ill prostate cancer patients, often as a palliative (such drugs are also sometimes used to treat sex offenders).

Fair enough, but did that reportsay that every last one of those 6,300deaths from users of those drugs was a cancer patient?It didnt, American Thinker continues.So we still dont know.

But heres what we do know: Lupron is being prescribed off-label for use in children who have been diagnosed with gender dysphoria [who claim theyre really the opposite sex] despite the lack of formal FDA approval for that purpose, the Daily Wire tells us.

Something else we can know was related by Michael Laidlaw, a California-based endocrinologist who revealed earlier this year that testosterone is now sometimes given to girls as young as eight years old. Gender dysphoria is not an endocrine condition, but is a psychological one and should, therefore, be treated with proper psychological care, he told the Christian Post in a December 2018 interview.

But it becomes an endocrine condition once you start using puberty blockers and giving cross-sex hormones to kids, he continued.

That gender dysphoria is a psychological issue is not opinion, but what all scientific evidence indicates. While sexual devolutionaries justify their biological interventions (i.e., hormone blockers, surgery) by claiming that a persons sense that hes a member of the opposite sex has a biological basis, this is a pseudo-scientific assertion, as explained in-depth here. Its damaging quackery.

In fact, Laidlaw knows of no psychological condition that is treated by putting hormones out of alignment from their normal levels, the Post also relates.

Moreover, the physician told the National Catholic Register that the drugs in question actually induce a known disease in previously hormonally healthy children.

The site continues, Puberty blockers, he explained, interfere with normal signals between the brain and the sex organs, thereby creating a disease state called hypogonadotropic hypogonadism in youths. Its a serious condition that endocrinologists would normally diagnose and treat because it interferes with development, but in [gender dysphoria] cases theyre inducing this disease state, Laidlaw said.

Additionally, today, medical scenarios such as girls as young as 13 and 14 undergoing double mastectomies and 17-year-old boys with penises of 9-year-olds, developmentally speaking, because of chemical puberty blockers, are now showing up, the Post relates about Laidlaws remarks at a March Heritage Foundation event.

This is all done under the nebulous concept of gender identity, he pointed out, something which no blood test, genetic testing, or brain imaging scans can find, the Post also relates him as saying. Laidlaw lamented that there is no objective test to diagnose this, yet we are giving very harmful therapies on the basis of no objective diagnosis.

He summed up, mincing no words, This whole thing is an experiment on children.

Of course, Laidlaw is hardly alone in sounding this alarm. Think-tank philosopher Ryan T. Anderson pointed out last year that transgenderism is delusion, renowned psychiatrist Dr. Paul McHugh has stated Sex change is biologically impossible, and former transsexual Alan Finch has said that you fundamentally cant change sex.... Transsexualism was invented by psychiatrists, to name just a few joining him.

The kicker is that as many as 88 percent of girls and 98 percent of boys who are gender (sexual-status) confused will naturally outgrow the phase; many transsexuals regret having chosen surgical sexual mutilation; and, according to Dr. McHugh, the suicide rate for those who have chosen it rises to 20 times that of comparable peers.

In reality, sexual-mutilation surgeries are the lobotomies of our time, brought to us by the same psychiatric establishment. Transgender is not a scientific designation, but a political one.

And because so much today is political and not rational is why plastic straws and vaping may be banned, while child-abusing quacks are allowed to commit body-rending malpractice with impunity.

Image: DNY59 via iStock / Getty Images Plus

View original post here:
Puberty Blocking Drug Used on Trans Kids Linked to Thousands of Deaths - The New American

A 28-year old woman arrived to the ER wheezing and short of breath. She had asthma and came in requesting a refill of her inhaler.

But when I examined her, I found out that something else much more serious was going on. The patients blood pressure was very high. Her legs and arms were swollen. Her lungs were filled with fluid. She told me that she had given birth a month before. During her pregnancy, she started having wheezing and trouble breathing, which she attributed to her asthma. Actually, she had untreated high blood pressure that progressed and worsened to life-threatening heart failure.

This scenario was tragically typical. As an emergency medicine physician working in ERs in Boston and Washington, D.C., I saw devastating cases like these far too often.

About 700 women in the U.S. die every year from complications of pregnancy, according to the CDC. And more than 50,000 women face severe health consequences in pregnancy. All of this is to say that women giving birth in the U.S. today are actually more likely than their own mothers to die in childbirth. In fact, more people in the U.S. are dying from pregnancy-related complications than in any other developed country, according to an investigation by NPR and ProPublica in 2017.

The public health crisis of maternal mortality is particularly acute for black women, who have three-to-four times the likelihood of dying in pregnancy and childbirth than white women. To some extent, this can be attributed to inequities in access to care, yet we know that these racial disparities persist even when controlling for all other factors. Structural racism in health care is a key contributor, as the research shows that health care providers are less likely to take the pain of black patients seriously. A recent study from the CDC found that three-in-five pregnancy-related deaths can be prevented, compounding the tragedy.

As a mother of a two-year-old, expecting my second child in March, I know that the period spanning pregnancy to parenting an infant is one of the most rewarding yet vulnerable times in a persons life. In medicine, we refer to pregnancy as a physiological stress test. A pregnant womans blood supply increases by nearly 50 percent; hormone levels fluctuate; and because of the growing uterus and increasing demands of the body, lung volumes reduce by five percent, while oxygen consumption increases. The levels of clotting factors in the blood increase in preparation for active labor, which is in itself a marathon that often lasts many hours.

The postpartum period is another time of incredible vulnerability. During this period, new mothers face a wave of new challenges that can accumulate and often compound mental health conditions like postpartum depression. After giving birth, they become full-time caregivers to a newborn, while learning breastfeeding, barely sleeping, and often navigating the return to work. In a country that lacks federal paid parental leave, many new mothers are back to work within weeks of giving birth, which can result in health consequences like maternal stress and anxiety. Medicaid coverage for new mothers, many of whom are people of color, ends at 60 days after delivery, and many people lose health insurance during this time of medical need. Through these challenges, parents often prioritize the care of their infants and push their own health aside; it is estimated that as many as 40 percent of women do not attend a postpartum visit.

In recent months, there has been increased attention to maternal deaths during childbirth. These are important calls to action, but we must also pay attention to the research that shows that the majority of maternal deaths occur outside of the labor and delivery period itself. Approximately two-thirds of maternal deaths occur before or even months after delivery, according to the CDC. These deaths are largely attributed to undertreated chronic illnesses such as heart disease, high blood pressure, and mental illness.

In order to improve maternal health, we have to focus on improving all womens health and access to carenot just during labor and delivery, but before and after pregnancy, and throughout our lives.

It is imperative that we address the barriers to access and the systemic racism that we know is contributing to our astronomically high maternal mortality rates. The onus must be on the health care system to make necessary changes. But we cant wait for systemic change to occur if we need medical care now. Here are a few crucial steps you can take to advocate for yourself and obtain the best care you can:

You can stay on top of your wellness visits. Regardless of whether or not you have given birth or plan to in the future, you can do your best to take care of your health now. Women are often caregivers for our loved ones, but we must care for ourselves to care for others. The best time to keep yourself healthy is before you get sick.

So instead of waiting for something to be up, go ahead and schedule a well-woman visit with your doctor. Your doctor can screen you for common conditions like high blood pressure and diabetes, which are associated with complications during pregnancy including heart disease, preeclampsia and eclampsia (pregnancy-related disorders of high blood pressure), placental abruption (when the placenta separates from the wall of the uterus), and gestational diabetes.

You should also get tested regularly for STIs. If left untreated, STIs can lead to pelvic inflammatory disease and ectopic pregnancy (a pregnancy that grows outside of the uterus), the most common cause of death among women during the first trimester.

Make sure that you are up-to-date with preventive testing such as Pap tests and breast screenings. Even if youre not pregnant, diagnosing and treating medical conditions now can prevent complications during a future pregnancy.

You can choose contraception if youre not looking to get pregnant. Birth control can help you plan and time your pregnancy, which can help some women get pregnant at a time that is best for them and their bodies. Experts estimate that without access to contraceptives, many more mothers would die globally from pregnancy-related complications. Another study found that increasing contraceptive use in developing countries has cut the number of maternal deaths by more than 40 percent over the past two decades.

Birth control can also be beneficial for many patients in ways that dont directly relate with becoming pregnant. It can help with symptoms of other conditions, like polycystic ovarian syndrome (PCOS) and endometriosis.

You can ask for help. This is true for all women, regardless of whether or not theyre pregnant or plan to be pregnant. But pregnancy and the postpartum period can be particularly vulnerable times for mothers, especially those experiencing a mental health condition or substance abuse or addiction.

It can be really hard to know where to turn when you need help, but one place to start would be your primary care doctor or a local health clinic. Remember that your mental health is just as important as your physical health. Tell your doctor if you have feelings of depression, anxiety, and trouble coping. If you find yourself relying on substances such as alcohol or opioids to deal with the stresses of life, you may have a medical condition that treatment can help.

If youre pregnant or have recently given birth and youre experiencing any worrying symptoms, do not hesitate to seek medical attention. For urgent concerns, go to the ER to get care.

The patient whom I mentioned earlier was in the Intensive Care Unit for a week. Though she will now always have a heart condition, she is able to live her life and care for her young daughter. Her outcome could have been vastly different had she not received care in timeand it could still have been different if her high blood pressure was treated much earlier.

Ending maternal mortality wont be easy, but as mothers, future mothers, spouses, and friends, lets start with what we can do right now. After all, to have healthy women, children, and families in the future, we must start with healthy women today.

Leana S. Wen, M.D. M.Sc. FAAEM is an emergency physician and Visiting Professor at the George Washington University Milken School of Public Health. Follow on Twitter: @DrLeanaWen.

Related:

See more here:
As a Doctor and Mother, Heres What I Wish People Knew About the Maternal Mortality Crisis - Self

Close

According to the U.S. Department of Health & Human Services Office On Womens Health, hormonal birth control can be broken down into two subtypes: long-acting reversible contraceptives and short-acting hormonal methods.

Suzanna Arul

According to the U.S. Department of Health & Human Services Office On Womens Health, hormonal birth control can be broken down into two subtypes: long-acting reversible contraceptives and short-acting hormonal methods.

Suzanna Arul

Suzanna Arul

According to the U.S. Department of Health & Human Services Office On Womens Health, hormonal birth control can be broken down into two subtypes: long-acting reversible contraceptives and short-acting hormonal methods.

I started taking birth control after my first ever trip to the gynecologist. I went in looking for answers to the typical questions: Why does penetration hurt? Why does my period feel like the scene in Prometheus when Noomi Rapace births an alien? It felt like I only received one question back: Why arent you on birth control?

Although I came in feeling like a strong woman taking charge of her health, I immediately felt like a teenage girl being warned not to get pregnant. My doctor took me through a birth control tour unprompted, showing off an IUD like a brand new Mercedes. I said I would think about it.

When an ultrasound technician found a cyst on my ovary, I received a phone call that amounted to: You have a cyst, were putting you on birth control. I was given no information on the type of ovarian cyst I had (there are many), no other treatment options, and no time to discuss which method was best for me.

According to the U.S. Department of Health & Human Services Office On Womens Health, hormonal birth control can be broken down into two subtypes: long-acting reversible contraceptives and short-acting hormonal methods.

Short-acting hormonal methods include the pill, shot, patch and vaginal ring. These methods work by releasing hormones into the body that thicken the cervical mucus to block sperm and can prevent ovulation altogether, according to Planned Parenthood. Long-acting reversible contraceptives such as hormonal intrauterine devices (IUD) or hormonal implants work the same way, but dont need to be used on a schedule.

I started on the combination pill, which contains estrogen and progestin. Three weeks later, during the week of my placebo pills, I got the flu. I ran a fever, had bouts of shivering so bad I couldnt walk straight, and couldnt even keep Gatorade down.

To give a better sense of just how sick I was, I alerted my roommate to check on me every few hours in case I needed to be carried to the emergency room. I paid $60 for a last-minute Tamiflu prescription and totally recovered within a week.

For the next three months, I got the flu on a consistent schedule of every four weeks. Recognizing that something was up, I made another doctors appointment (I would rack up about $350 in copayments by the end of this story).

My doctor called my case unusual, but did little more than a basic blood test before sending me home with a new prescription for a slightly lowered dosage of the same pill. Between January and April, I tried two new pills that would surely fix my mystery illness, yet I continued to get sick every month like clockwork.

I missed parties that my friends still reminisce on and full weeks of class. I showed up at one male professors office the day a paper was due, mumbling something about hormone levels and blood tests because I knew one mention of my period meant hed stop taking my problem seriously.

If youve ever suffered from a recurring health issue, you know that after a while people start to blame you for not getting better already. I felt like I was constantly over-explaining, trying to prove that I wasnt just having bad periods; I was suffering every month.

When the semester ended, I braced myself for a serious conversation with my doctor. I was leaving for a two-and-a-half-month internship in South Africa, and I couldnt miss work or a travel opportunity because I was sick.

She started me on the Nuvaring, which is a self-inserted vaginal ring containing hormones. She said that the localized hormone dispersal should make my symptoms less severe.

I got on the plane with a box full of Nuvarings and awkwardly told my new roommates that yes, there were contraceptives in the fridge. I had such high hopes for this method that when I still got sick, I called home and cried.

I stayed home instead of going to see the Southernmost tip of Africa because of my birth control. To make matters worse, I felt like my peers didnt even believe I was sick because I couldnt explain what I was sick with.

Research has shown that women are more likely to have their pain dismissed by medical professionals and less likely to receive diagnosis or treatment, according to The New York Times. I couldnt stop thinking about how maybe if birth control were a mens health issue, there would be a name and an explanation for what was happening to me.

I decided then that I would quit hormonal contraceptives cold turkey as soon as I got back to the U.S.

When I told people I was done with birth control, a lot of them responded with, What are you going to do now? in a disapproving tone, as if I couldnt be trusted to make decisions about my own body or keep myself from getting pregnant.

Increasing awareness about sexual health is a good thing, but sometimes hormonal contraceptives are painted as the only responsible option. My story with birth control has shown me that the most responsible way to approach reproductive health is to know your body and trust yourself to decide what it needs.

If you decide to use hormonal contraceptives, it should be because you want to, and it should be prescribed by a physician who will listen to, believe and treat you.

Go here to see the original:
My story with birth control - The Cluster

The former Oasis frontman Liam Gallagher has spoken about how Hashimoto's thyroiditis might shorten his career but a specialist tells Medscape News UK the condition is very treatable.

Hashimoto's thyroiditis is typically more common in middle-aged women and can run in families.

Liam Gallagher first talked about his diagnosis and hoarse voice in 2017, including in an interview with the Guardian .

Now, ahead of a 47th birthday homecoming concert in Manchesterin an interview with Apple's Beats 1 he's talked about how the condition might end his career: "Im aint going to get any bigger. If anything, its only going to get worse. You are in that zone now, youre looking about and youre going. All right. I kind of see whats going on but, its all about the journey man.

However, he was reflective about his future career: "If it lasts 10 years, it lasts 10 years. If it lasts 5 years, it lasts 5 years. If it ends tomorrow, Ive still had a f-ing blinder do you know what I mean?"

He continued saying Hashimotos disease "makes your voice a lot hoarser. Thats some of the symptoms.

Dr Paul Jenkins is a consultant physician and endocrinologist at The London Endocrine Centre, and a board member of The Thyroid Trust. He spoke to Medscape News UK.

How can Hashimoto's affect the vocal cords?

If it's untreated, it does cause the cords to be swollen, and to result in a hoarse voice. That's one of the classic signs of an underactive thyroid.

What about the singing style?

With a change in their vocal range, the tenor of their voice, in their singing.

Effective treatment should be able to restore this but not always.

And will it, as Liam Gallagher fears, worsen over time?

No, it should not worsen over time. But most of us don't use our vocal cords so strenuously day-to-day. If you're really straining them I guess it's conceivable, but it shouldn't really worsen.

Is a 'rock-and-roll' lifestyle unhelpful for Hashimoto's?

No, I don't think you could say that. Hashimoto's disease is a very common autoimmune condition of the thyroid gland, where the body's immune system starts attacking it.

Liam Gallagher spoke of it possibly ending his career. Would a more positive attitude be helpful?

That's his thoughts on it. I can't say whether it's positive or negative, it depends on one's overall context.

He's been out of the public eye for some time. So he hasn't been singing as much as he used to.

What kind of treatment regime might he be following?

It is thyroid hormone replacement. It's taking exactly the same hormone as the body is not making butin a tiny pill form.

It is for life, because once the thyroid gland has been destroyed, it does not ever heal itself in this condition.

Are some cases more complex?

Some patients need additional treatment, not just with the thyroxin, but they can continue to have symptoms of underactive thyroid, even if they're taking apparently adequate doses of thyroxin. And we increasingly recognise that they require T3, which is the other active thyroid hormone, in addition to thyroxin.

Is Hashimoto's hard to diagnose in primary care?

No, it should not be hard to diagnose overt cases. There is, as always the grey cases, those that you're not absolutely certain about or don't tick all of the boxes. And that's when a specialist can be prepared to even just try some thyroxin to see if it helps. Certainly, specialists are needed to diagnose those individuals who don't convert the thyroxin to the T3, and who need additional T3.

That's a more controversial area but undoubtedly in my experience, very, very much does exist. And that needs specialist input.

Is it helpful for a major celebrity to come forward and talk about a condition like this?

I think it can be helpful for any celebrity to talk about their conditions, if it raises public awareness of the condition and the treatments to restore it.

So the more debate and discussion, and knowledge generally is a good thing, as long as it's responsible knowledge, and people are given the true facts about their condition.

I'm very happy for him to raise awareness of it and to discuss it.

See the article here:
Will Hashimoto's End Liam Gallagher's Singing Career? - Medscape

Its a real bummer when Aunt Flo arrives unexpectedly, but it can be even more panic-inducing when she doesnt show up at all. Every woman has a late or missed period at some point and the first step to figuring out why is getting familiar with your period before its missed. In order to determine your normal menstrual cycle it is important to keep track of when you have your period through a calendar or app on your phone, says Shannon Schellhammer, M.D., F.A.C.O.G., an obstetrician/gynecologist at Orlando Health.

Essentially, every womans body is different and works at its own speed. In fact, despite the popular belief that there are 28 days in a menstrual cycle, a 2019 study of more than 600,000 women in the journal Nature found that only 13% of women have 28-day cycles, and 29.3 days is actually the average length. On top of that, the International Federation of Gynecology and Obstetrics reports that a normal cycle can range anywhere from 24 to 38 days.

Your period is late if you are more than five days past the expected start date of your period, says Jacqueline M. Walters, M.D., an obstetrician/gynecologist and author of the forthcoming book The Queen V: Everything You Need to Know About Sex, Intimacy, and Down There Health Care. Your period is considered missed if you have gone more than one to two weeks past the expected start date. Our bodies are so complex that the potential reasons why you might miss a period are endless, but here are a few common ones.

1. Pregnancy

The number one cause for a missed period is pregnancy! says Dr. Schellhammer. She advises taking a home pregnancy test if you are sexually active, regardless of your age and form of birth control. Once you rule out pregnancy, it is safe to wait for the next month to see if you have a normal period. However, if you are concerned or do not have a clear cause of why you missed your period, I recommend you call your OB/GYN or primary care doctor to be seen. This is especially important if you have not been seen within the last year for an annual well-woman exam.

2. Stress

Stress whether its from something great like planning a wedding, starting a job, or moving to a new house, or something not-so-great like job loss, a bad relationship, or depression can press pause on your period. The chemistry required to develop and produce a normal cycle can be influenced and delayed by high levels of cortisol and/or adrenaline, which increase in the body as a result of chronic, daily stress, says Hector O. Chapa, M.D., F.A.C.O.G., clinical assistant professor of obstetrics and gynecology at Texas A&M University College of Medicine. This delayed cycle may be your bodys way of reminding you to take care of yourself. If stress is the cause for your missed period, it should resume when things in your life calm down.

3. Polycystic Ovarian Syndrome (PCOS)

"Without a doubt, PCOS is the most common hormone imbalance in women that leads to delayed or missed cycles in women aged 18 to 44, excluding pregnancy, says Dr. Chapa. The condition occurs when a woman produces more male hormones than normal. While blood tests and a vaginal ultrasound may support a diagnosis, the diagnosis may be considered if a woman has two of these three symptoms: excess facial or male-pattern hair growth, irregular periods and ovaries that appear to have little cysts. Theres no cure, but your OB/GYN can help you find the right treatment to get your cycle back on track. If PCOS isnt the culprit, your physician can help you figure out if another hormonal imbalance caused by thyroid or pituitary problems is at play.

4. Excess exercise

Exercise is necessary for our well-being, but too much of itwithout the caloric supportcan take a toll on our bodies and trigger missed periods. The female athlete triad occurs when a female athlete has low energy intake or disordered eating, menstrual delays or absence and low bone mass, says Dr. Chapa. Along the same lines, a bodyweight thats more than 10% below the ideal weight for your height can mess with your menstrual cycle.

Rattankun ThongbunGetty Images

5. Medications

When you put a chemical into your body (including herbal supplements), it can cause a chain reaction that spreads across different systems. Birth control, antipsychotics, antidepressants, and chemotherapy can all cause a missed period, says Dr. Walters. If you recently started a new medication and started skipping periods, bring it up with your physician to see if its a normal side effect. For instance, with some contraceptives including IUDs, the shot, and certain birth control pills your period may stop altogether.

6. Perimenopause

Unless the ovaries are surgically removed, menopause doesnt just happen, says Dr. Chapa. The interval leading up to menopause is called the perimenopause and is marked by hot flashes, mood changes, and of course, changes in the menstrual cycle called skips and delays. While the average age of menopause in the U.S. is 51, Dr. Chapa says these changes can start anytime in your 40s.

The bottom line: A missed period rarely causes immediate harm to a womans health, but it does signify something underlying, says Dr. Walters. If the pattern continues, it can affect a womans ability to get pregnant, cause bone loss, lead to ovarian cysts, and cause excessive male-pattern hair growth thinning or balding on the head and more hair on the face, chest and abdomen. No one knows your body better than you so the best thing you can do is pay attention and dont hesitate to give your OB/GYN a call if something feels off.

See original here:
6 Reasons for a Missed Period Why Your Period is Late, According to Doctors - GoodHousekeeping.com

September 25, 2019 Whole breast radiation and partial breast radiation following a lumpectomy yield similar cosmetic outcomes for women diagnosed with early stages of cancer who wish to preserve their breasts. Findings of the new analysis from a phase III clinical trial were presented at the 61st Annual Meeting of the American Society for Radiation Oncology (ASTRO), Sept. 15-18, 2019,in Chicago.

Partial breast radiation is a good choice. Thats what Im going to say to certain subsets of my patients, said Julia White, M.D., FASTRO, a professor of radiation oncology at The Ohio State University Comprehensive Cancer Center and lead author on the abstract.

Women diagnosed with early stages of cancer (stage 2 or earlier) who undergo lumpectomies typically follow their surgery with radiation therapy to lower the risk of having the cancer return. Partial breast radiation can be an appealing treatment option, because the radiation is delivered over several days to a smaller area around the surgical site instead of 3 to 4 weeks to the entire breast.

Previously published results from this phase III trial, NRG Oncology/NSABP B39-RTOG 0413, found partial breast radiation to be only slightly less effective than whole breast radiation at reducing the risk of cancer recurring in the breast. There were no significant differences between treatment groups in overall survival rates, the time patients lived without the cancer coming back or the time patients lived without the cancer spreading to another site. In the current analysis, White and her team focused on cosmetic outcomes to help guide patients for whom both treatment choices would be equally or nearly equally effective for breast-conserving therapy.

In this analysis of 900 women with early-stage breast cancer who received either partial breast radiation (n=477) or whole breast radiation (n=423), both the patients and their physicians were asked to rate the cosmetic outcome of the treated breast, in comparison to the untreated side, as either excellent, good, fair or poor at three different times (baseline, 12 months after treatment and three years after treatment). Patients also rated their satisfaction with the outcome. Additionally, digital photos of the womens breasts acquired at each time point were rated by two teams of three physicians each who were blinded to which treatment the women received, when the photos were taken or which breast was treated.

We found that whether the women received whole breast radiation or partial breast radiation, there was an equivalent cosmetic outcome from the patients' perspective, said White. This pattern held whether the patient also received chemotherapy as well as radiation and lumpectomy. In addition, patients' satisfaction with their treatment and cosmetic outcome were equivalent for whole breast and partial breast radiation. Three years after completing radiation therapy, 81 percent and 86 percent of patients said they were totally satisfied with partial breast or whole breast radiation, respectively; 14 percent and 11 percent were somewhat satisfied; 2 percent and 3 percent were neither satisfied nor dissatisfied; 1 percent and 2 percent were somewhat dissatisfied; and less than 1 percent of patients in each group said they were totally dissatisfied with their treatment.

Treating physicians rated cosmetic outcomes from partial and whole breast radiation as equivalent at one year after treatment (p=1.00), but outcomes from partial breast radiation were considered worse at three years after treatment (p=0.001).

The physicians who reviewed digital photos without knowing if or when the breast received radiation rated cosmetics outcomes as equivalent for partial and whole breast radiation at one year (p=0.99) and three years (p=0.99) after treatment. There were differences between the ratings for patients who did or did not receive chemotherapy, however, with outcomes after partial breast treatment rated slightly worse among patients who received chemotherapy and outcomes after whole breast radiation rated slightly worse in the non-chemotherapy group.

Agreement between the patient and physician ratings was notably stronger when patients had better cosmetic outcomes after treatment. On average, patients who scored their outcomes as "excellent" or "good" (versus those who rated them as "fair" or "poor") agreed with their doctors' ratings 89 percent (vs. 45 percent) of the time and agreed with physicians making photo-based ratings 85 percent (vs. 32 percent) of the time.

White said the findings were important for women facing difficult choices after being diagnosed with breast cancer. If a patient chooses breast conservation for her treatment, she generally wants the breast to feel and look as normal as possible. It is difficult to have to say to a patient that she can have a shorter, more convenient treatment but will have to accept a cosmetic outcome that is not as nice as she would get with a longer treatment. We were relieved to find out the cosmetic outcomes are equivalent.

Understanding the physicians perspective on cosmetic outcomes as well as the patients was important, said White, because how the physician regards the results of treatment will help guide improvements in care. I am happy that the cosmetic outcomes based on the patients assessment and physician review of the digital photos were in agreement, she said. On the other hand, doctors who treat patients will ask themselves what they could have done differently to reach a better outcome or start cataloging what they did to reach the positive one, perhaps leading to innovations that improve outcomes.

The results of NSABP B39-RTOG 0413 and other randomized trials indicate that patients with Stage 0 or 1 breast cancer, who are over the age of 50 and have hormone-sensitive disease, would benefit equally well from partial or whole breast radiation for breast-conserving therapy, consistent with the ASTRO Consensus Statement for Partial Breast Irradiation. This subset of patients with breast cancer accounts for roughly 25-30 percent of new cases treated, or about 30,000 women each year, said White.

View additional coverage of ASTRO 2019

For more information: http://www.astro.org

Visit link:
Partial and Whole-Breast Radiotherapy After Lumpectomy Provide Equally Satisfying Cosmetic Results - Imaging Technology News

Now, in addition to the nightmare of cancer, I had the nightmare of having to make a decision.

Two weeks post lumpectomy, the bruising and swelling were slowly going away. I stopped worrying about recovery and started agonizing about what lay ahead. If there were any benefit to doing chemo to decrease my chances of becoming metastatic, I should take it. I want to be alive when my kids get married and spoil my future grandchildren, even if that means torturing my body for a few months.

My husband, Kevin, a family practice physician, tried to talk me down. One-point-six percent is insignificant compared to how it could weaken your immune system, cause permanent nerve damage, osteoporosis it could even give you another cancer or kill you. You should trust your doctor. And your husband.

I wanted to. But the market researcher in me trusted information. I needed to collect qualitative and quantitative data and analyze which choice I would regret more. Which would allow me to live most fully and take care of the people I love?

At restaurants, waiters try to hide their irritation as I scroll through Yelp reviews on my phone to ensure the most popular dishes are being ordered. My notes on choosing a preschool were so robust I turned them into a how-to book. My newfound research project gave me the opportunity to feel as if I were actively doing something to heal myself.

Each night, once I heard Kevin snoring, I sat up against the headboard, turned on my iPad and lowered the screen brightness. I hurled myself down the rabbit hole of news articles, breast cancer websites and community forums. The TAILORx study was so new, however, there wasnt much information and no concrete answer.

In my support group, most of the conversation revolved around tips for getting through chemo the depression, mouth sores, numb hands and feet, and what to do when hair that fell out never grew back. I couldnt relate and didnt want to, yet somehow I envied them for being fighters.

One day I read about another test called MammaPrint. At our next appointment, my doctor happily showed me that those results also supported the argument against chemo. Time had run out and that was the final data point I needed. We arranged to start my month of radiation treatment the following week, followed by five years of daily hormone blocker pills. I apologized for second-guessing. She gave me an understanding smile and replied, Knowledge is power. She hugged me, said congratulations, and I was on my way. Decision made.

Originally posted here:
Is Everyone Doing Chemo Without Me? - The New York Times

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced the presentation of four IBRANCE (palbociclib) real-world analyses. The studies support the effectiveness of IBRANCE combination therapy in everyday clinical practice and provide additional insights on its use in certain patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). The posters will be presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain on Sunday, September 29.

Among the data, Pfizer will share the first real-world comparative analysis of a CDK 4/6 inhibitor in combination with an aromatase inhibitor compared to an aromatase inhibitor alone.

We have an opportunity to make positive changes in cancer care by incorporating learnings from real-world data in addition to data gathered from clinical trials, said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. We are pleased to share this view of the impact IBRANCE has had on patients treated outside of traditional clinical studies, as it continues to add to the body of evidence for IBRANCE and provides insights into the patient experience.

About the Real-World Comparative Analysis

In this retrospective analysis (Abstract #329P: Comparative effectiveness of palbociclib plus letrozole vs. letrozole for metastatic breast cancer in U.S. real-world clinical practices), treatment with IBRANCE plus letrozole demonstrated a statistically significant improvement in real-world progression-free survival (rwPFS) compared to letrozole alone: 24.5 months (95% CI = 20.7 32.7) versus 17.1 months (95% CI = 13.7 19.8) (HR = 0.68, 95% CI = 0.56 0.84, p = 0.0003).

To help deliver the best care to our patients, it is critical that physicians have compelling evidence of a medicines benefit on patients who resemble those who they treat every day, said Rachel Layman, M.D., Associate Professor, Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center. The real-world evidence presented at ESMO provides a more robust understanding of the effectiveness of IBRANCE in patients who may not be reflected in the randomized trials.

The analysis compared 906 matched patients with HR+, HER2- MBC who started IBRANCE plus letrozole as initial endocrine-based therapy in the metastatic setting (n=453) or letrozole alone (n=453) from February 2015 to August 2018. rwPFS was measured by the treating physicians clinical assessment of source evidence, such as radiographic scans or pathology from the Flatiron Health longitudinal database. The most recent update for this database includes de-identified electronic health records from more than 280 cancer clinics representing more than 2.2 million cancer patients in the U.S.

The additional real-world posters at ESMO examining the use of IBRANCE in patients with HR+, HER2- MBC are:

To further educate the global oncology community about the importance of real-world data at ESMO, Pfizer is sponsoring a satellite symposium, Real World Data in Oncology: Its Growing Role in Research and Patient Care. The symposium will take place on Friday, September 27, from 6:00 8:00 pm CEST at Fira Gran Via in the Alicante Auditorium (Hall 3).

About IBRANCE (palbociclib) 125 mg capsules

IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are key regulators of the cell cycle that trigger cellular progression.2,3 In the U.S., IBRANCE is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.

The most common adverse reactions (incidence 10%) associated with IBRANCE are neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia. Today in the U.S., IBRANCE is the most prescribed FDA-approved oral combination treatment for HR+, HER2- metastatic breast cancer.

IBRANCE currently is approved in more than 90 countries and has been prescribed to more than 230,000 patients globally.

The full U.S. Prescribing Information for IBRANCE can be found here.

IMPORTANT IBRANCE (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.

Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.

Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.

The most common adverse reactions (10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).

The most frequently reported Grade 3 adverse reactions (5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%).

The most common adverse reactions (10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).

The most frequently reported Grade 3 adverse reactions (5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%).

Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.

For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis.

About Pfizer Oncology

At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 22 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, prostate, kidney and lung cancers, as well as leukemia and melanoma. Pfizer Oncology is striving to change the trajectory of cancer.

Pfizer Inc.: Breakthroughs that change patients lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com. In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of September 24, 2019. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about IBRANCE (palbociclib), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of IBRANCE; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any additional jurisdictions for IBRANCE for potential HR+/HER2- metastatic breast cancer indications or in any jurisdictions for any other potential indications for IBRANCE; whether and when any such other applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of IBRANCE; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

____________________________1 IBRANCE (palbociclib) Prescribing Information. New York. NY: Pfizer Inc: 2019.2 Weinberg, RA. pRb and Control of the Cell Cycle Clock. In: Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY: Garland Science; 2014:275-329.3 Sotillo E, Grana X. Escape from Cellular Quiescence. In: Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY: Humana Press; 2010:3-22.

Visit link:
Pfizer Presents New Evidence of IBRANCE (palbociclib) Effectiveness in HR+, HER2- Metastatic Breast Cancer Patients in Four Real-World Studies at ESMO...

Newman Center offering classes in bioethicsFILE PHOTO | THE SPECTRUMCatholic-specific courses held through NDSU.

Saint Pauls Catholic Newman Center, home of the bisonCatholics, has introduced a new course this semester. The ethics course, advertised for students going into the health professions, is meant to teach bioethics through the lens of Catholic dogma. The source of the course material as well as the introduction of religious ethical teachings sets an unusual, and perhaps concerning, precedent for classes at NDSU.

The course is listed as CHP 391: Fundamentals of Catholic Healthcare Ethics and Bioethics. The term Catholic bioethics and the idea of a course directed at health professionals seems like a bit of a paradox considering the churchs historical relationship with science and medicine. The full course takes place over three semesters and results in a certification from the National Catholic Bioethics Center (NCBC).

In an email sent out to bisonCatholics using NDSU logos, the course was described as follows: The National Catholic Certification Program in Health Care Ethics has been developed at the request of many bishops and administrators of health care facilities to provide a credible and systematic formation so that dioceses, hospitals and ethics committees will have advisors better qualified to apply the Catholic moral tradition to challenging contemporary issues in healthcare. For a three-semester course, which provides students with nine NDSU credits, the description is especially vague.

The class is taught by the Monsignor, Gregory Schlesselmann, using course modules developed by the NCBC; so, the question is: What is the National Catholic Bioethics Center? According to the website, the NCBC, Conducts research, consultation, publishing and education to promote human dignity in health care and the life sciences, and derives its message directly from the teachings of the Catholic Church. Again, this is a fairly vague description, but you can probably imagine what these messages from the Catholic Church might be.

The NCBC uses legislation and outreach to promote Catholic values within medical professions. Their stances on abortion and assisted-suicide can be easily imagined: strongly opposed. However, it is their views on topics such as gender identity and same-sex marriage that cause surprise and concern.

NCBC share regular updates, one such update stated: NCBC joins medical associations in advising the US Supreme Court that reinterpreting in federal law the term sex as gender creates a subjective and unworkable means of categorization. This ideology leaks into their work trying to legislate for policies that would protect medical professionals who do not want to assist patients trying to get gender reassignment surgery or hormone therapy.

They elaborate on this by saying, We believe that the best therapies for gender dysphoria will seek to make patients comfortable in their own bodies, rather than take unnecessary medical risks to attempt the impossible and make their bodies reflect their feelings. They are essentially saying that individuals who wish to go through gender reassignment surgery should instead receive psychological treatment to accept their bodies.

Another disturbing take from NCBC has to do with the medical professionals obligations to respect the marital status of same-sex couples. Their exact words on the topic were, There is a fundamental difference between the marital relationship of one man and one woman, with the ensuing rights recognized for the well-being of children and society, and committed relationships between two persons of the same sex.

With all of this information in mind, you may ask: Why should we care? Sure, its no secret how the Catholic church feels about abortion, same-sex marriage, gender identity and physician-assisted suicide. However, when a course promoting Catholic views on all these topics is being taught through NDSU, these feelings go beyond religious expression into the muddied waters of possible discrimination.

NDSU anti-discrimination policy specifically states that programs cannot discriminate on the basis of sexual orientation or gender identity; however, CHP 391 is being taught through an organization who is fighting for legislation that will discriminate on those bases specifically. The course seems to provide future medical professionals with legal tools to avoid treating certain patients. Its difficult to see how this course work will not directly contradict NDSUs own policies.

The real concern is how instituting religion-specific ethics courses, or any other courses directly in favor of a specific religion will affect the NDSU community. NDSU is at its most beautiful and progressive when multiple religions and diverse backgrounds are present. If courses are to be taught that support Catholic doctrine, where can we draw the line from stopping courses being taught which encourage other religious teachings, which propagandize certain political ideologies or that blatantly encourage the discrimination of identities held by NDSU students?

While I am not Catholic, I can say with absolute certainty that I would not want courses held at NDSU which only serve to encourage my personal beliefs. Individuals come to college to broaden their perspective and learn about disparate points of view. As of now, no rules may technically have been broken. However, the possibility that an individual may find themselves in the hands of an NDSU health professions graduate and not be served due to identity or spiritual belief should concern both the students and the administration. A precedent has been set and the resulting dangers could be substantial.

See the rest here:
Religion in the health professions - NDSU The Spectrum

MedicalResearch.com Interview with:Adrian E. Bostrm MD, on behalf of the authorsDepartment of NeuroscienceUppsala University, Sweden

MedicalResearch.com: What is the background for this study?

Response: While prevalence estimates vary, literature indicates that hypersexual disorder (HD) affects 3-6% of the population. However, controversy surrounds the diagnosis and little is known about the neurobiology behind it.

Hypersexual disorder has not previously been investigated with regards to epigenomic and transcriptomics in a hypothesis-free study approach and little is known about the neurobiology behind this disorder.We investigated whether there were any epigeneticchanges that affect gene activity and expression in hypersexual disorder (HD)patients and identified a dysregulated microRNA that is believed to influence the mechanism of action of the hormone oxytocin in brain.

Oxytocin is known to have wide-rangingbehavioral influences. To the bestofour knowledge, no previous study provided evidence for an association between DNA methylation, microRNA activity andoxytocin inhypersexual disorder.Our findings merits further research in the role of MIR4456 and especially Oxytocin in hypersexual disorder. Further studies are needed to confirm the role of Oxytocin in HDand to investigate whether treatment with oxytocin antagonist drug therapy could have beneficial effects for patients suffering from hypersexual disorder.

MedicalResearch.com: What are the main findings?

Response: In this study we investigated over 8000 different DNA methylation sequenced in a hypothesis-free and thereby unbiased manner. Therefore, we were intrigued and surprised to identify a strongly dysregulated microRNA targeting genes primarily expressed in brain and that are involved in major neuronal molecular mechanisms thought to be relevant for hypersexual disorder, e.g. the oxytocin signaling pathway. This microRNA alsoappears to be evolutionary conserved throughout primates, which is also an interesting and unexpected finding.

MedicalResearch.com: What should readers take away from your report?

Response: Hypersexual disorder incorporates different pathophysiological mechanisms including impulsivity, compulsivity, sexual desire dysregulation and sexual addiction. This can be interpreted such that hypersexual disorder contains addictive elements, but is not to be seen as exclusively an addiction. Our findings, in light of the crossover with alcohol dependence, suggest that MIR4456 and the oxytocin signaling pathway may be primarily involved with the addictive component of hypersexual disorder. Further studies are needed to fully confirm this.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Our results motivates further research in the efficacy of, for example, oxytocinregulating drug therapy in hypersexual disorder whichcould contribute to novel treatment options to improve the clinical outcome of those affected. In addition, we identify a specific microRNA (miRNA)for whichfuture potentialmiRNAregulating drugs could be tested in hypersexual disorder.

MedicalResearch.com: Is there anything else you would like to add?

Response: Our DNA is genetic code for genes that translate into different sequences of amino acids calledproteins. Proteins, in turn, constitute a main definingelement of all living things. Our DNA is inherited and does not change over time. This study, however, pertained to epigenetics, which arechanges that affect gene activity and expression. These epigenetic activitieschange over time and can be dysregulated in certain ailments. There are different epigenetic mechanisms.

In this study, we studied DNA methylation (a process known to influence gene expression, that is, the quantityof a gene that is translated into a protein)and microRNA activity(short non-coding gene segments that can influence the translation of several hundred different genes).

Comparing patients with hypersexual disorder to healthy volunteers, we identified a DNA methylation sequence to be significantly altered in hypersexual disorder. To ascertain the significance of this finding, the same DNA sequence wasfurther demonstrated to be dysregulated in subjects with alcohol dependence, suggesting it could be primarily associated with the addictive component of hypersexual disorder. The identifiedDNA methylation sequence was associated to a microRNA called (microRNA 4456; MIR4456), and further analysis showed that this DNA methylationsequence influence the quantity of MIR4456 that is produced.Furthermore, in the same study group, we demonstrate that MIR4456 exists in significantly lower quantity in hypersexual disorder as compared to healthy volunteers, strongly suggesting that altered DNA methylation patterns in hypersexual disorder influence and contributes to explaining the observed dysregulation of MIR4456.As microRNA:s theoretically are abletotarget several hundred different genes, we used computer algorithms to reveal that MIR4456 targets genes that arepreferentially expressed in brain and that are involved in major neuronal molecular mechanisms thought to be relevant for HD, e.g., the oxytocin signaling pathway. Our findings merits further research in the role of MIR4456 and especially Oxytocin in hypersexual disorder. Further studies are needed to confirm the role of Oxytocin in HDand to investigate whether treatment with oxytocin antagonist drug therapy could have beneficial effects for patients suffering from hypersexual disorder.

Yet unpublished data intended for a separate follow-up study show a highly significant increase in Oxytocin levels in patients with hypersexual disorder as compared to controls, and a significant reduction in oxytocin levels after Cognitive Behavior Therapy treatment, strongly implying a causal role of Oxytocin in hypersexual disorder andmaking the claims presented in this study much stronger. These preliminary results have been presented as a late breaking poster in Society of Biological Psychiatry meeting in May 2019 and also submitted as a poster in ACNP in December 2019.

Citation:

Adrian E. Bostrm et al, Hypermethylation-associated downregulation of microRNA-4456 in hypersexual disorder with putative influence on oxytocin signalling: A DNA methylation analysis of miRNA genes,Epigenetics(2019).DOI: 10.1080/15592294.2019.1656157

We respect your privacy and will never share your details.

Last Modified: Sep 23, 2019 @ 9:38 pm

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

Post Views: 266

Link:
Epigenetic Changes Linked to Hypersexual Disorder and Addictive Behaviors - MedicalResearch.com

BALTIMORE With violent crime in Baltimore approaching an all-time high, its no secret that much of the malfeasance gripping the city is drug-related. But should law-abiding citizens who apply for a Maryland State Police Handgun Wear and Carry Permit be required to list anxiety, hormone, erectile dysfunction, and breast cancer medications as part of the application process? And what about banking? Should the way you handle your cash invalidate your right to self-protection?

To understand the troubling intimidation factor that intrusive medical and money questions bring to Marylands Wear and Carry Permit application process, we spoke with Post-Examiner contributor Brian Bissett. Bissett is currently appealing his second consecutive restricted Maryland concealed carry permit and has asked the Maryland State Police to open their files as a part of that appeal process.

This is the second part of a two-part interview. The first part of this interview may be found here.

BPE: Your comments in the previous article about the politics surrounding gun legislation were most enlightening. But Id like to get back to the carry permit application process with a couple of oft-asked questions. First, do you have any idea how many gang members annually apply for a carry permit?

Bissett: I have no idea, but I cant imagine it would be many.

BPE: Do you have any numbers on how many felons have attempted to lawfully purchase a gun?

Bissett: No, I dont have any statistics for those things either.

BPE: I realize it may appear that I just set up a couple of straw men for you to knock down, but dont questions such as these help us get around to the thorny issue at hand that is what kind information the State Police should and should not be tracking in the permit process?

Bissett: I believe that they have been tracking all this information for a while, and Ive been told they have a database with all of this information.

Certain information on those applications is what Im looking for.

In fairness to the Maryland State Police, it may not go back as far as I want. But they most certainly have a database for all of this permit information going back the last twenty years.

They could easily query the information Ive requested.

BPE: What sort of information are you requesting?

Bissett: Id like to look at the racial breakdown of approvals and denials, as well as the kind of personal information which has been mined and stored.

One of the things I found troubling when I first went through the permit process is, I was asked on my interview to put down every single prescription drug I am taking.

I was pretty taken aback by that. What if you are a man taking Viagra or a woman taking Avasitin for breast cancer? Should that be included on any sort of application? Come on you could never get a judge to sign a search warrant for that.

Race is one of the questions an applicant must answer on the Maryland State Police Concealed Carry Permit application.

BPE: How does the State Police application on this point compare to what you underwent for a Federal Government security clearance?

Bissett: In the Federal process, they are only allowed to ask a physician one question in regard to mental health: If the person under investigation has a condition that could impair judgment, reliability, or ability to properly safeguard classified national security information?

If the answer is No, no further questions can be asked. If the answer is Yes, only then they may ask additional questions.

Do questions about embarrassing medical or mental health conditions dissuade people from applying for a permit?

The question here is, why arent the Maryland State Police only asking, If the person under investigation has a condition that could impair judgment, reliability, or ability to properly and safely carry a firearm in public?

The fishing expedition of requiring everyone to give personal medical information including all prescription medication they are taking and any mental health diagnosis is in my opinion a violation of HIPAA and done to dissuade and intimidate those with any embarrassing medical or mental health conditions from applying for a permit.

Is it their business if someone has breast cancer, erectile dysfunction, or general anxiety disorder? Quite frankly, its amazing nobody has sued them over this issue.

BPE: Isnt it reasonable, though, to ask if the applicant is on any psychotropic medications?

Bissett: I would say no, in most cases, unless the person has a history of schizophrenia or is bi-polar. People who have some type of mental disorder tend to be victims of violent crime more than they are perpetrators.

Dont get me wrong. I believe that people who have been forcibly institutionalized because they present a danger to themselves probably shouldnt be allowed to obtain a permit. But if you are taking a prescription medication to help you relax when you fly? There they want a note from your doctor, and what doctor can predict a persons mental condition once they leave the office?

Look, people go through problems all of their life. They get divorced; they lose a loved one to death. They may be treated for depression and then they recover. Should an incident such as profound grief mean they should be denied the right to own a firearm in perpetuity?

BPE: Doesnt the Federal Background Instant Check system look at that sort of thing, too?

Bissett: Thats a very difficult question to answer, and the only reason I know this much about it is because Im presently taking a Department of Defense class.

There is not a single database or repository that a law enforcement agency can go to that will necessarily pick up every arrest and/or crime a person may have committed. The records are siloed to a certain degree. Then when it comes to mental health, youre in a whole other ball game, because those records have also been siloed. Then there is HIPPA and the Privacy Act. Most organizations will err on the side of caution because they are potentially liable for millions of dollars if they disclose certain information.

The thing that disturbs me and I know others feel this way as well is that they are effectively ending mental health treatment in this country.

When you have something like the New York Safe Act, where a mental health professional must report anybody who might be a risk, they report everyone, no matter how minute the risk, and that discourages people from seeking the treatment they need.

If you drive people underground, and they dont seek treatment, you create the potential for even greater problems.

BPE: As we are speaking, Baltimore City is quickly approaching the 250 murder mark for the year. Its also gearing up for a major election. Is anyone in the mix for political office there taking a pro-gun or a pro-self defense position?

Bissett: I wouldnt know, to be honest with you, because I dont follow city politics to that degree. The one thing I can tell you is that I often listen to an African-American talk radio station, and whenever the subject of gun ownership comes up, four out of five callers express outrage that they cannot either purchase a firearm or get a permit to carry one.

There are no shooting ranges in Baltimore City. (Wikimedia Commons)

When the state passed the Firearms Safety Act of 2013, they created a process that was much more complicated for your average person to buy a firearm. They have to take a safety course and fire one bullet out of a handgun. But there are no ranges in Baltimore City. So, you are not going to be able to fulfill that requirement using public transportation.

There is a requirement to get fingerprinted, and I dont know how many places do that in Baltimore City. Then there is the requirement to complete the application online using a credit card.

Believe it or not, there is a class of people in this country who do not use credit cards.

BPE: That would bring us back to the hypothetical case of the house-keeper or the carpenter who just deals in cash?

Bissett: Yes. Then they have to use a scanner to enter their documents. Brian Frosh says they can just go to a library, but here you have individuals who are not technically savvy, using equipment which may be on lock-down or not adequately secure. It really puts city residents at a disadvantage to buy a gun, not to mention trying to obtain a carry permit.

BPE: Wouldnt such technical requirements particularly discriminate against African-American and Hispanic city residents?

Bissett: I believe they do. Given everything we have talked about here, African-Americans and Hispanics are much less likely than a white person to be able to navigate the handgun permit process. And yet, they are more likely to be the victim of a crime.

Lets face it: The State Police have created a process that is so intricate, so complicated, so convoluted, that a recent immigrant or an uneducated person doesnt stand a chance.

Maryland Attorney Gen. Brian Frosh.

If you compare a person who went to Harvard to someone who went to Baltimore City Public Schools, the city resident is much less likely to navigate that process.

BPE: Yet the Harvard graduate isnt the one living in a dangerous neighborhood?

Bissett: Exactly, and that is where people like Civil Rights Attorney Dwight Pettit contend that this system is inherently racist.

BPE: You did a pretty thorough job of charting the correlation between strict gun laws and an increase in crime in Baltimore City. Have you looked at other Maryland Counties?

Bissett: I have not because, frankly, getting the numbers together for Baltimore and similar cities was hard enough. I knew Id be crucified for any mistake, and to date, nobody has challenged the validity of the numbers I published in the graphs. Its always been, Well, even though there may be a mathematical correlation, I dont believe this is the cause.

Thats the reason I went through the Bradford-Hill causality theorem. It shows that, more likely than not, restricting an honest persons access to a firearm is going to result in more crime. By restricting I mean going beyond checking a persons background at the point of the sale.

I support the instant background checks, which determine that this person is who they say they are; that this person is not a felon, and is qualified to own a gun. However, I dont think that stops anyone who wants to own a gun from obtaining a gun. What it does do is it prevents them from getting the gun as quickly as theyd like to. But thats a topic for another conversation.

BPE: Where are Americans today on the right to carry?

Bissett: Well, following the Florida example, weve gone from states enacting Shall Issue laws to the Constitutional Carry which means you dont need a permit to carry your firearm as long as you are a law-abiding citizen. I believe there are now thirteen states which allow you to strap it on your hip. They said the same thing about that that they did about concealed carry permits, but by and large that hasnt happened.

BPE: So, in your opinion, Maryland lags behind on idea of a Constitutional Right to carry?

Bissett: I believe the county is moving in that direction. And not just conservatives.

I have a good friend at work, and his wife has been a social worker in Baltimore City for the past 25 years. Interestingly enough, this guy is very liberal, but he and I are very good friends.

I put this friend down as a reference, when I applied for my carry permit. I was later told that when the investigator called him, he said, Let me be perfectly clear: I dont like guns, I dont own guns, I dont believe in guns. And I think the world would be a better place if there were no guns. But if anybody should be carrying a gun, its this guy.

BPE: Wow!

Bissett: Yeah, the investigator said he had never heard a reference like that before. Anyway, as I said, this mans wife has been a social worker for a long time in Baltimore City. She works with a lot of disadvantaged youth, and they have all told her the same. If youd like a gun, I can have one for you in an hour.

BPE: What does it cost to buy such a handgun in Baltimore City?

Bissett: She said the answer from all of them is also the same. That depends on how many people have been killed with it. If no one has been killed with the gun, then thats a clean gun. Those guns cost top dollar. The more crimes that can be tied to a gun, the cheaper it becomes.

(This is the second part of a two-part interview. The first part may be found here.)

Here is the original post:
Concealed Carry: Does Maryland State Police Need to Know if Permit Applicant is Taking Viagra? - Baltimore Post-Examiner

Events

n Crosskeys Human Resources Inc. is offering flu shots 10:30-11:30 a.m. Sept. 23 at the Brownsville seniors center, 302 Shaffner Ave., and 11 a.m. to noon Oct. 2 at the Republic facility, 36 Fairgarden St., Republic. A professional from Rite Aid in Grindstone will administer the shots. Participants must bring Medicare/other insurance cards for payment.

n Monongahela Valley Hospital will host a prostate cancer screening and education program at 5 p.m. Sept. 25 in the education conference center. The event is free. At the screening, men will be offered a digital rectal exam (DRE), the standard test for prostate cancer; a hemocult test and a Prostate Specific Antigen (PSA) blood test. The screening and education program will be conducted by MVH staff. Registration: 724-258-1333.

n Monongahela Valley Hospital will host a multiphasic blood analysis 7-10 a.m. Sept. 28 in the education conference center. This 36-function screening costs only $30 and is open to the public. Additional tests available include: Immunochemical Fecal Occult Blood, 3-D mammogram, Hemoglobin A1C, Thyroid Stimulating Hormone, Prostatic Specific Antigen, and Vitamin D. Participants are asked to provide the full name and complete address of the physician to whom their test results will be sent afterwards. Testing is by appointment only. The deadline to register is Sept. 25, and registrations must be made Monday through Friday from 8:30 a.m. to 2:30 p.m. by calling 724-258-1282.

n Medicares annual open enrollment period runs Oct. 15 through Dec. 7. For a list of enrollment centers and their dates and times open for enrollment, call Southwestern Pennsylvania Human Services, Inc. at 724-489-8080.

Courses

n Exercise classes, Tuesdays and Thursdays, Center in the Woods, 130 Woodland Court, Brownsville. Classes include chair dancing at 9:30 a.m. followed by healthy steps at 11 a.m. Information: 724-938-3554.

n Monongahela Valley Hospital will host a free talk about Gastrointestinal Reflux Disease (GERD) on Thursday, Oct. 3, at 6 p.m. in the Anthony M. Lombardi Education Conference Center at Monongahela Valley Hospital. Dr. Arshad Bachelani will discuss GERD, a digestive disorder in which the contents of the stomach flow back into the esophagus, leading to heartburn, difficulty swallowing, regurgitation of food and cough, to name a few. Long term GERD can lead to complications in the esophagus that can make swallowing difficult, cause an ulcer or the cause development of precancerous cells. Dr. Bachelani will talk about treatment options available that include medications as well as surgery. Registration: monvalleyhospital.com or 724-258-1333.

n Monongahela Valley Hospital will host a free talk about Cervical Disc Replacement at 6 p.m. Oct. 15, in the Anthony M. Lombardi Education Conference Center. Dr. Eric Nabors will discuss diseases that affect cervical discs, causing chronic neck and/or arm pain and treatment options. He will thoroughly cover surgical treatment option of cervical disc replacement by describing the procedure, when it is a viable option and who is a good candidate for the surgery. Registration: monvalleyhospital.com or call 724-258-1333.

n The four-week Smoke Free For Life program, sponsored by BREATHE Pennsylvania will be hosted by the Monongahela Valley Hospital 9-11 a.m. every Monday in September. Program participants will learn how to overcome barriers that keep them from quitting, develop a customized quit-plan that will lead to success, learn the art of positive self-talk, practice sound techniques to manage stress, develop strategies that will prevent relapse and receive support in a positive and comfortable environment. The session is broken down into four, two-hour courses. Space is limited and pre-registration is required. Registration: 724-258-1462.

n Monongahela Valley Hospital will host a Weight Control and Wellness Support Group at 6 p.m. Sept. 23 in the education conference center. The bariatric support group activities are designed to reinforce key principles of success and help participants learn concepts that are sometimes difficult to grasp after bariatric surgery. Professionals such as dietitians, psychologists and fitness instructors may be invited to speak. Other presenters may discuss topics such as grooming, dating and cooking. The ultimate purpose of the support group is to help participants achieve and maintain their goal weights in a way that is as physically and mentally healthy as possible. Registration: 724-258-1333.

n Monongahela Valley Hospital will host the course Advanced Carbohydrate Counting from 9 to 11 a.m. Sept. 26 in the education conference center. This program is a diabetes self-management class designed to educate you on how to count carbohydrate content in food to improve blood sugar control. Topics include how to track effects of carbohydrates and blood sugar, glycemic index and how to read food nutrition labels. Registration is required at least one week prior to the start of class by calling 724-258-1483.

n Monongahela Valley Hospital through the Community Care Network is offering a Smoke Free for Life program from 11 a.m. to 1 p.m. Sept. 23 and 30 in the education conference center. The four-week program is broken down into four, two-hour courses and is designed to help participants develop strategies to quit smoking, prevent relapse as well as receive support in a positive and comfortable environment. Registration: 724-258-1462.

Support groups

n Breaking Addiction, HEAL Group for Men. This small group meeting for men is designed to help those who have a desire to overcome addictions and find a new direction in life. All sessions give instruction for practical life skills through Biblical Principles found in Gods Word. Discussion and interaction are encouraged at each group meeting. They are scheduled at 7 p.m. the first, second and fourth Thursdays of the month at Eagle Ranch Ministries Inc., 1579 Pleasant Valley Road, Mount Pleasant. Registration: 724-542-7243.

n Breaking Addiction, HEAL Group for Women. This small group meeting for women is designed to help those who have a desire to overcome addictions and find a new direction in life. All sessions give instruction for practical life skills through Biblical Principles found in Gods Word. Discussion and interaction are encouraged at each group meeting. The meetings are scheduled for 7 p.m. every Tuesday at Eagle Ranch Ministries Inc., 1579 Pleasant Valley Road, Mount Pleasant. Registration: 724-244-5261 or 412-969-8520.

n Caregiver support group, 6:30-8:30 p.m., the fourth Wednesday of the month at Lafayette Manor. Classes meet in the new physical therapy department. Light refreshments are provided. Open for family and friends who have lost a loved one to cancer. Registration: http://www.excelahealth.org or 877-771-1234.

n Mon Valley Hospital will host a Suicide Bereavement Support Group 12:30 p.m. Sept. 23 in the education conference center. This support group is a four-month program that meets the second and fourth Mondays of each month. This program is led by a licensed psychologist and is free and open to all those touched by suicide. Required registration: 724-678-3601.

n Grief support group, 6-8 p.m. first Tuesday of every month, at the St. John the Evangelist Church on West Crawford Avenue in Connellsville. The group is a collaborative effort for those facing grief due to the loss of a loved one from addiction. Information: 724-628-6840.

n Al-Anon Family Groups, 8 p.m. Wednesdays, Trinity Church parlor, Fayette and Morgantown streets, Uniontown. Please enter at the handicapped ramp entrance. A second is scheduled for 7:30 p.m. Fridays, Christian Church, Pittsburgh Street, Connellsville. These meetings are for anyone who has been affected by or is having problems from someone elses drinking. Information: al-anon.alateen.org or pa-al-anon.org.

n Survivors of Incest Anonymous group, 6:30-8 p.m. the first and third Mondays of the month, excluding holidays. This 12-step recovery program is meant for men and women aged 18 or older who were sexually abused by a trusted person as a child. The group meets at the Mount Macrina Retreat Center. A similar group, Healing Friends, is from 6:30-7:30 p.m., East Liberty Presbyterian Church in Pittsburgh, on the second and fourth Tuesdays of the month. Information: peopleofcourage@gmail.com siawso.org, or healingfriends8@gmail.com.

n Missing Piece of My Heart support group, 6-8 p.m. the last Thursday of each month at the Crime Victims Center conference room in the Oliver Square Plaza. The group is for families who have lost a child to a violent crime. Information: 724-438-1470.

n Silver Generation Support Program, 10 a.m. to noon Wednesdays, East End United Community Center, Uniontown. The program is for ages 55 and older. Information: 724-437-1660.

More here:
Health briefs 09-23-19 | Healthy Living - Uniontown Herald Standard

Sleep problems are one of the most common ME/CFS symptoms. Sleep dysfunction is a critical piece of the complex puzzle that is chronic fatigue syndrome, and ME/CFS (myalgic encephalomyelitis / chronic fatigue syndrome) patients are eager for treatments that will help to improve and normalize their sleep. When I was diagnosed with ME/CFS by my primary care physician, she said, The first thing to do is to correct your sleep problems. That will make all of your other chronic fatigue syndrome symptoms improve. She was right! Here are ways to help you fall asleep faster, sleep better, and wake up feeling refreshed.

In order to treat ME/CFS sleep dysfunction, it helps to understand what healthy sleep looks like. A night of refreshing sleep consists of sleep cycles, moving through various stages in a predictable pattern:

Those deep Stages 3 and 4 are especially important for immune health, endocrine (hormone) function, and energy; its when our bodies recover and rebuild.

A healthy endocrine system, which produces hormones at the right times and in the right amounts, helps regulate sleep (and everything else).

Why do ME/CFS patients feel like we are half-awake all night and still exhausted in the morning? Traditional sleep studies comparing ME/CFS patients to healthy controls often find no measurable differences in our sleep cycles, though some show reduced total sleep time and sleep efficiency. Newer studies, using entirely different ways of measuring sleep, though, are finding that ME/CFS patients have more disruptions in REM sleep and deep stage (3 & 4) sleep. Our brains will sometimes jump right from REM or even deep stage sleep into being awake or in light Stage 1 sleep, instead of cycling through each stage as is normal. These REM disruptions in the studies correlated with worse symptoms the next day.

The hormone side is also not entirely clear. The few studies of serotonin levels in ME/CFS patients have shown contradictory results, though some do show abnormal serotonin function, indicating our bodies arent controlling serotonin the way a healthy body should. This matters because sleep deprivation causes a multitude of serious health problems, worsening every aspect of ME/CFS.

When an ME/CFS patient mentions sleep problems, doctors usually send him/her for a sleep study. The problem is, as noted above, that even carefully controlled scientific studies often fail to show abnormalities in our sleep using standard measures. Sleep studies do have an important function, though. They are designed to diagnose primary sleep disorders, like sleep apnea, restless legs syndrome, and narcolepsy. Plenty of ME/CFS patients also have a sleep disorder (some studies indicate we have a greater risk of primary sleep disorders), and its important to diagnose and treat those. Consider a sleep study to diagnose or rule out a primary sleep disorder, but dont expect it to find much with respect to your ME/CFS sleep dysfunction.

The key to correcting our sleep problem at its source is to target those hormones that are responsible for good quality sleep. This is different than taking sedatives to knock you out; it means actually correcting the problem so that your sleep feels normal and natural, and you wake up feeling refreshed. There are different ME/CFS treatment approaches to try, and it often takes some trial and error, sometimes combining treatments, to find what works best for you. Work with a doctor to find the right combination and to prevent increasing serotonin too much.

My son and I both have ME/CFS, plus tick infections, but I listened to my doctor all those years ago and treated sleep dysfunction first. Once my son got sick, we did the same for him, and we have both been sleeping a solid 9-11 hours of good quality, normal-feeling sleep every night for over twelve yearsand waking up feeling refreshed most mornings.

I first tried amitriptyline at its lowest dose, but it left me groggy in the morning. Next, I tried nortriptyline liquid in tiny doses (we started with that for my son) and gradually increased the dose as needed, until we each leveled out at an effective dose; then we switched to more convenient capsules. After a year or two, the nortriptyline wasnt working quite as well, so we added trazodone, again starting low, at just 25 mg. We both ended up (hes an adult now) at a combination of 50 mg nortriptyline and 100 mg trazodone (low doses compared to what is used for depression). We both also take melatonin supplements (5 mg for me and 8 mg for him), and I have a prescription for low-dose Ambien that I only use rarely, when I travel. We both also take plenty of magnesium, B6, and the other nutrients listed above.

Although the sleep dysfunction of ME/CFS cant be corrected just with standard guidelines for sleep hygiene, you do need to promote better sleep, in addition to whatever treatments you try. As one sleep expert explains, getting a good nights sleep requires an intricate coordination of many different elements, including some of the basics:

Myalgic encephalomyelitis and chronic fatigue syndrome are a complex web of intricate causes and effects, involving every system in the body. When sleep is disrupted, problems in the endocrine, immune, and nervous systems occur, worsening all ME/CFS symptoms. Similarly, when you treat sleep problems in ME/CFS, there will be improvements in all of these systems, leading to improved symptoms. Best of all, improving those systems will lead to even better quality sleep, in a positive domino effect. The best treatment approaches not only help you fall asleep and stay asleep but improve the quality of your sleep so that you wake up feeling refreshed and ready for a new day.

Suzan Jackson, a frequent ProHealth contributor, is a freelance writer who has had ME/CFS since 2002 and also has Lyme disease. Both of her sons also got ME/CFS, in 2004, but one is now fully recovered after 10 years of mild illness and the other just graduated from college, with ME/CFS plus three tick-borne infections. She writes two blogs, Living with ME/CFS at http://livewithcfs.blogspot.com and Book By Book at http://bookbybook.blogspot.com, and wrote an upcoming book being released in fall 2019, Finding a New Normal: Living with Chronic Illness. You can follow her on Twitter at @livewithmecfs.

Resources:

Trazodone (Desyrel) Is. Phoenix Rising website.

Alban, D, Alban P. Use Tryptophan to Boost Serotonin for Better Mental Health. Be Brain Fit website (April 3, 2019).

Bell, D. Sleep in CFS. Lyndonville News (January 2005) 2(1).

Castro-Marrero, J, SezFrancs, N, et al. Treatment and Management of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: All Roads Lead to Rome. British Journal of Pharmacology (March 2017) 174(5), pp. 345-369.

Cleare, A. The Neuroendocrinology of Chronic Fatigue Syndrome. Endocrine Reviews (April 1, 2003) 24(2), pp. 236-252.

Field, T, Hernandez-Reif, M. et al. Cortisol Decreases and Serotonin and Dopamine Increase Following Massage Therapy. International Journal of Neuroscience (July 7, 2009), pp. 1397-1413.

Jackson, ML, Bruck, D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine (December 15, 2012) 8(6), pp. 719-28.

Kishi, A. Presentation: Sleep Disturbances in ME/CFS. The National Academies of Science, Engineering & Medicine Health and Medicine Division. May 5, 2014.

Kishi, A., Natelson, BH., et al. Sleep-stage Dynamics in Patients with Chronic Fatigue Syndrome with or without Fibromyalgia. Sleep (November 1, 2011) 34(11), pp. 1551-60.

Lapp, C. Using Antidepressants to Treat Chronic Fatigue Syndrome. CFIDS Chronicle (Summer 2001).

Morillas-Arques, P,Rodriguez-Lopez, CM,et al. Trazodonefor the treatment offibromyalgia: an open-label, 12-week study. BMC Musculoskeletal Disorders(Sep 10, 2010) 11, p. 204.

Rowe, PC, Underhill, RA, et al. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Diagnosis and Management in Young People: a Primer. Frontiers in Pediatrics (June 19, 2017).

Yamamoto, S, Ouchi, Y, et al. Reduction of Serotonin Transporters of Patients with Chronic Fatigue Syndrome. NeuroReport (December 3, 2004) 15(17), pp. 2571-4.

Go here to read the rest:
Treating Sleep Problems in Chronic Fatigue Syndrome - ProHealth

Bathrooms are one of the only places where we can expect to have complete privacy. In todays world, we bring technology with us everywhere we go. The bathroom is the last sacred place where some of us leave technology behind and completely disconnect. Not for long...

For a while, determined Japanese companies have been bringing innovation to a niche market; the smart toilet market. They have been up to selling high-tech toilets at exorbitant prices since the 1980s. Meanwhile, on the other end of the globe, the Western world has been ignoring a much-needed toilet upgrade. Some of the earliest innovations in the Japanese toilet industry include heated seats to make you as comfortable as possible, remote controls that let you flush the toilet and close the lid with the press of a button and the use of ultraviolet rays to clean the toilet bowl and get rid of bacteria.

How could AI possibly contribute to improving your toilet? Toilets will now be equipped with Amazons Alexa so you can finally order you it to play music, close the lid, flush etc with voice commands, completely hands-free. These toilets are sold, randing from 1000 up to TOTOs 10000 toilet. TOTO was the first company to create smart toilets and they have mastered this market space. An American based company called Kohler has started making their own range of smart toilets which are becoming increasingly popular in the western world, shifting more people away from using traditional toilets.

See more here:
AI in smart toilets- could identify signs of diseases - AI Daily

If youre preparing for the United States Medical Licensing Examination (USMLE) Step 1 exam, you might want to know which questions are most often missed by test-prep takers. Check out this example from Kaplan Medical, and read an expert explanation of the answer. Also check outall posts in this series.

A 32-year-old woman comes to the physician because of amenorrhea for the past 15 months after delivering a baby. She says that she has also had fatigue, facial swelling, cold intolerance and has gained an additional 4.5 kg (10 lb) since her baby was born. A review of her records shows that the delivery was complicated by severe hemorrhage. Laboratory studies of serum show:

LH <1 IU/L

Estradiol 5 pg/mL (normal 20100 pg/mL)

TSH 0.1 U/mL

Injection of 500 g of TRH fails to produce an increase in either serum TSH or prolactin. Assay of other hormones is most likely to show normal levels of which of the following hormones?

A. Aldosterone

B. Cortisol

C. Follicle-stimulating hormone (FSH)

D. Gonadotropin-releasing hormone (GnRH)

E. Growth hormone

The correct answer is A.

Sheehan syndrome is hypopituitarism caused by ischemic damage to the pituitary resulting from excessive hemorrhage during parturition. The pituitary is enlarged during pregnancy; it is more metabolically active and more susceptible to hypoxemia. The blood vessels in the pituitary may be more susceptible to vasospasm because of high estrogen levels. In about 30 percent of women who have excessive hemorrhage during parturition, some degree of hypopituitarism eventually manifests.

The symptoms depend on how much of the pituitary is damaged and what cell types are destroyed. Although some pituitary hormones may be unaffected, even in severe hypopituitarism, pituitary hormones and the hormones controlled by them are more likely to be reduced than hormones that are not primarily controlled by anterior pituitary function. Our patient has amenorrhea (decreased LH) and symptoms of hypothryoidism (decreased TSH). Aldosterone secretion is relatively independent of adrenocorticotropic hormone; it is controlled mainly by angiotensin II and plasma potassium concentration. Aldosterone is least likely to be reduced by hypopituitarism. Treatment is replacement of thyroid hormone and cortisol.

Read these explanations to understand the important rationale for each answer to help you prepare with future studying.

Choice B: Cortisol is controlled by pituitary production of ACTH; because ACTH is often impaired in Sheehan syndrome, reduced secretion of cortisol is likely.

Choice C: The pituitary necrosis that is the root cause of Sheehan syndrome is highly likely to reduce secretion of follicle-stimulating hormone (FSH). The observation of reduced estradiol in this patient strongly suggests that FSH is low because estradiol increases as follicular development occurs.

Choice D: The presence of the depressed levels of estradiol and leuteinizing hormone (LH) in this patient releases hypothalamic secretion of GnRH from its normal feedback control. GnRH levels are likely to increase above normal.

Choice E: Growth hormone is very likely to be reduced by the pituitary necrosis.

For more prep questions on USMLE Steps 1, 2 and 3, viewother posts in this series.

The AMA selected Kaplan as a preferred provider to support you in reaching your goal of passing the USMLE or COMLEX-USA.AMA members can save 30% on access to additional study resources, such as Kaplans Qbank and High-yield courses. Learn more.

Read the original:
Kaplan USMLE Step 1 prep: Woman has amenorrhea after birth of baby - American Medical Association

Monday, September 23 marks the next equinox and the start of Autumn season in the Northern Hemisphere, where days will begin to get shorter, nights get dark earlier, and the temperatures will drop.

Monday marks Autumnal Equinox, one of two days when the sun is located exactly above the Earths equator and day and night are roughly equal.

Fall is an easy season to love. One thing you might not realize, though, is that the change in temperature has some effects on your health.

Here are 19 surprising ways fall weather affects your wellbeing, according to msn.

1. Your risk of heart attack increases

Your heart definitely isnt a fan of that chill in the air. "In colder weather, we typically see rates of heart attacks go up," says New York City-based internist and cardiologist Edo Paz, MD, a doctor with K Health. "There are various reasons for this, including increased blood pressure and increased risk of blood clots. The best way to mitigate this risk is to dress warm."

2. Your eyes get dry

The cold, dry air of the fall has a tendency to dry your eyes out and leave a burning sensation in its wake. "Seasonal changes like dryer air make dry eye worse," according to the experts at Piedmont Eye Care in Charlotte, North Carolina. Thats because they either "cannot produce enough tears or they produce low-quality tears."

When your eyes are begging for moisture, you can get some relief by using artificial tears or getting some eye drops from your doctor. The optometrists at Piedmont also suggest getting a humidifier, protecting your eyes outside with either a hat or sunglasses, staying hydrated, taking breaks from screen time, and trading in your contacts for glasses.

3. Your skin becomes cracked and dry

Cold weather doesnt just bring on eye dryness. It also dries out your skin, says Paz. To combat the problemand make sure youre not itchy and cracked all season longuse plenty of lotion, load up on sunscreen, and skip the long, hot showers and baths, which only dry your skin out even more.

4. You experience more aches and pains

Always feel more achy in the colder months? Youre not alone. Research has shown there may be an association between colder temperatures and an increase in aches and pains, particularly in the back and neck areas.

There are multiple theories behind this, but one prominent one, according to University of Chicago Medicine rheumatologist Anisha Dua, MD, MPH, is because of the "drops in barometric pressure, which causes tendons, muscles, and the surrounding tissues to expand." According to Dua, "because of the confined space within the body, this can cause pain, especially in joints affected by arthritis."

5. Your vitamin D levels plummet

In the summertime, all that sunshine you absorb gives you more than enough vitamin D. However, once the season shifts, thats not quite the case anymore.

"In the fall, our vitamin D levels fall rapidly," says Kristine Blanche, PhD, RPA-C, owner of the New York-based Integrative Healing Center. According to Blanche, as your vitamin D levels fall, youre not only more susceptible to colds and the flu, but this can also affect your hormone levels.

6. You feel depressed

Fall should bring on joy in the form of fun family-centric holidays and cozy movie nights by the fire. However, its also known to bring on the seasonal affective disorder (SAD), which "can cause depression symptoms typically due to less exposure to sunlight, says Paz. His advice? "Stick to a regular workout routine" to keep your endorphin levels up.

7. And you lack energy, too!

SAD doesnt just affect your mood. It also affects your energy levels. Along with making you depressed, the seasonal disorder can also cause you to feel sluggish and agitated come fall, according to the Mayo Clinic. If this is the case for you, chat with your doctor about treatment options so the changing seasons dont dampen your spirits.

8. You have trouble breathing

Once the air gets cold, you might have a harder time breathing. According to the American Lung Association, cold, dry air can irritate the airways of those who are already dealing with breathing issues from asthma or chronic obstructive pulmonary disease (COPD). If you know you have airway issues, always make sure youre bundling up and avoid exercising outdoors when the air is especially dry.

9. Youre at a higher risk of getting sick

When the temperature drops and youre spending more time indoors, youre at a higher risk of coming down with a cold or the flu. According to Berkeley Wellness at the University of California, people pick up viruses in the fall not from the weather itself, but from the subsequent time spent indoors in close proximity to others. Of course, sitting within close range of someone whos sick increases your chances of picking up their germs.

10. Your allergies take a turn

Your allergies are inevitably going to be impacted by the fall weather. However, whether thats for the better or for the worse depends on what exactly youre allergic to.

"The arrival of fall weather will bring relief for some, and a worsening of symptoms for others," says California-based physician Alexandra Stockwell, MD. "Anyone who suffers from an allergy to pollen will start to feel some relief when temperatures drop, humidity improves, and pollen is no longer in the air. And for anyone allergic to mold, the fall weather can exacerbate symptoms. Mold thrives in leaf piles, compost piles, and anywhere organic matter is decomposing. Because its airborne, you can be negatively impacted by mold from surrounding areas."

11. You get more headaches

Its not uncommon for cold weather to cause headaches. Thats because, according to the Mayo Clinic, the fall season is full of migraine triggers, ranging from dry air to barometric pressure changes.

12. You sleep better

When you get enough sleep every night, your mood improves, your energy levels increase, and you have fewer junk food cravings. And the transition from summer to fall could be the key to finally helping you get on a solid sleep schedule.

"Going to bed earlier as it gets dark earlier results in better quality sleep, better insulin control, and feeling rested enough to work out the next day," says Monica Auslander Moreno, MS, RD, LD/N, nutrition consultant for RSP Nutrition in Miami Gardens, Florida. Its a win in the bedroom that translates to more success in the kitchen, at the gym, and pretty much everywhere else.

13. You experience hair loss

According to The Choe Center For Hair Restoration in Virginia Beach, Virginia, people typically lose between 50 and 100 strands of hair a day. However, in the fall monthstypically in October and Novemberthis number tends to be closer to 100. If you notice some extra shedding in the shower or when youre brushing your hair in the fall, its likely nothing to worry about.

14. Your diet could get better

During the summer months, its fun to get out and enjoy the warm weather at outdoor bars and restaurants. In the fall, however, youre much more inclined to make the most of your kitchen, which is great news for both your wellbeing and your waistline.

"The cooler temperatures make fall a great time to hit up the farmers markets and add some local and seasonal foods into your diet," says Sheli Msall, RDN, the dietitian behind Nutritionist Abroad. "Its also a fun season to cook and bake in, as you dont mind warming up the kitchen now that its getting cooler outside."

15. Or you might pack on the pounds

While fall can bring on healthy eating habits, the change in season can also have the opposite effect. "When the weather turns colder, we generally adjust our eating styles to warm comfort foods associated with family events and holidays," says Brenda Rea, MD, DrPH, PT, RD, family and preventive medicine physician at Loma Linda University Health in Loma Linda, California. "This often can result in more hot and sugary drinks, hot soups laden with saturated fat and salt, and, of course fruit pies with sugar, saturated fat, and refined flour."

Luckily, Rea says that these comfort foods can easily be replaced with similarand much healthier!alternatives that are just as satisfying. "Hot sugary drinks can be replaced with hot green tea or lemon water; soups can have less salt and no added fats while still maintaining a fabulous taste, and fruit can be consumed fresh and made into a fruit compote with dates for sweetening," she suggests.

16. You could inadvertently be warding off inflammation

Chronic inflammation can lead to a long list of health problems, from heart disease to autoimmune disorders. The good news? Having the urge to sip on some tea during the chilly fall months could help fight it off. "Fall teas and spices are anti-inflammatory," says Moreno. Sip on green tea, turmeric tea, and ginger tea for the best results.

17. You might become more active

During the summer, the sun is strongoften too strong to allow for a run or any other type of outdoor workout. Once fall hits, though, the weather cools down a little, making it a great time to up your activity levels before winter hibernation hits.

"As the weather cools, its a perfect opportunity to bike, walk, or run outside in the crisp fall weatherespecially in the mornings before work and on weekends," says Moreno. "Who doesnt like to ogle the beautiful foliage?"

18. But you could also become more sedentary

Though for some people the tepid temperatures of fall are ideal for outdoor activities, for others, its quite the opposite. The cooler weather could send you straight into hibernation-mode, causing you to abandon your exercising habits in favor of lounging on the couch.

If youre avoiding the outdoors, make sure youre at least incorporating some at-home exercises into your routine. There are plenty of different apps, online workout programs, and free videos on YouTube to take advantage of.

See the original post:
It's officially autumn..see how autumn weather may affect your health! - Roya News English

September 18, 2019 Last night the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for the treatment of metastatic hormone-sensitive (aka, castration-sensitive) prostate cancer (mHSPC). Apalutamide has previously received FDA-approval for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

PCF funded the initial synthesis of apalutamide at UCLA by chemist Michael Jung, PhD, in collaboration with prostate cancer physician-scientist Charles Sawyers, MD (now at Memorial Sloan Kettering Cancer Center).

mHSPC refers to men whose prostate cancer has spread to areas of the body outside of the prostate itself, and who are responsive to testosterone-lowering agents. This may refer to men who have had prior surgery or radiation and recurred, or men who were initially diagnosed with disease that was already metastatic (outside the prostate). Patients who are hormone-sensitive may have previously received androgen deprivation therapy (ADT) for a certain amount of time, but their cancer has not yet developed resistance to ADT.

This approval is based on results from the randomized phase 3 TITAN clinical trial, which was presented at the 2019 American Society of Clinical Oncology (ACSO) Annual Meeting, held in June, and published in the prestigious medical journal, The New England Journal of Medicine.

The TITAN trial, led by PCF-funded investigator Dr. Kim Chi, MD, of the Vancouver Prostate Centre, tested the addition of apalutamide versus placebo, to ADT in 1,052 men with mHSPC. Patients on this trial could have previously received ADT for no more than 6 months for mHSPC or no more than 3 years if used as adjuvant therapy for localized prostate cancer, and were not on ADT at the time of disease progression and trial enrollment. Patients could also have previously received docetaxel chemotherapy for no more than 6 cycles, and could not have progressed on that treatment.

Compared with a placebo, the addition of apalutamide to ADT significantly reduced the risk of death by 33%, and reduced the risk of radiographic disease progression (tumors growing on scans) or death (whichever came first) by 52%. Apalutamide also significantly delayed the average time to PSA progression, use of chemotherapy, and pain progression. Apalutamide was shown to prolong survival of patients with both low and high volume metastatic disease. The treatment combination of apalutamide and ADT was considered tolerable, and quality of life in patients receiving apalutamide was similar to those receiving placebo in addition to ADT. Adverse effects that were higher in patients receiving apalutamide vs placebo included rash (27% vs. 8.5% of patients), hypothyroidism (6.5% vs. 1.1% of patients), and fractures (6.3% vs. 4.6% of patients).

More information on this approval can be found here.

Read the original:
BREAKING NEWS: FDA Approves Apalutamide (Erleada) for the treatment of metastatic hormone-sensitive prostate c - Prostate Cancer Foundation