Amgen and The University of Texas MD Anderson Cancer Center announced two multi-year collaboration agreements aimed at accelerating development of a variety of Amgen’s early-stage oncology therapies for patients with leukemia, myelodysplastic syndromes, multiple myeloma, small-cell lung cancer, and other non-lung cancers with small-cell histologies. The agreements combine Amgen therapies nearing clinical development or those that have already begun the process with MD Anderson’s translational medicine capabilities. The collaborations will focus on Amgen’s bispecific T cell engager BiTE , chimeric antigen receptor CAR T cell and small molecule programsThe five-year collaboration will begin with Phase 1 clinical studies for BiTE antibody constructs and CAR T cell therapies for multiple myeloma and small cell lung cancer. The second agreement spans four years and will study BiTE antibody constructs, CAR T and small molecule treatments in leukemia and myelodysplastic syndromes. The collaboration includes multi-institutional pre-clinical and clinical trials, some of which will be led by MD Anderson, which may offer the potential for identifying new biomarkers.
Thursday, May 31, 2018
Regeneron’s investigational Ebola treatment shipping to Congo
Regeneron Pharmaceuticals’ investigational therapy that combines three fully-human monoclonal antibodies, REGN-EB3, is being shipped to the Democratic Republic of the Congo for use in the current Ebola virus infection outbreak. REGN-EB3 is one of several investigational therapeutics evaluated for use by a panel of independent scientific experts convened by the World Health Organization and selected for inclusion in a potential WHO-coordinated clinical trial. A new publication from the Journal of Infectious Diseases describes development of REGN-EB3 and efficacy results at different doses in animal models. In three preclinical studies, REGN-EB3 was seen to treat advanced Ebola virus disease and prevent mortality of infected non-human primates. Regeneron worked with the WHO and FDA to develop an Expanded Access Program protocol to support use of this treatment in the most recent outbreak in the Congo. Regeneron has secured various regulatory approvals, country approvals and import licenses and has hundreds of doses of REGN-EB3 ready to ship beyond the initial shipment currently in process. REGN-EB3 has received orphan drug designation from both the FDA and European Medicines Agency. It is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
Reata gets Euro orphan drug tag for kidney med candidate
Reata Pharmaceuticals announced that the European Commission, or EC, has granted orphan drug designation, based on the positive opinion from the Committee for Orphan Medicinal Products, or COMP, of the European Medicines Agency, or EMA, for bardoxolone methyl for the treatment of Alport syndrome. Alport syndrome is a rare, genetic form of chronic kidney disease, or CKD, caused by mutations in genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney. A majority of patients with Alport syndrome develop CKD and many progress to end-stage renal disease. In the Phase 2 portion of the Phase 2/3 CARDINAL study, bardoxolone significantly increased patients’ estimated glomerular filtration rate after 36 weeks of treatment
Globus started at buy by Cantor
Globus Medical initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Craig Bijou started Globus Medical with an Overweight rating and $65 price target. The analyst sees several sales growth drivers for the company, including a U.S. core market rebound, early success of emerging technologies and traction of the acquired ATEC international platform.
K2M started at buy by Cantor
K2M Group initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Craig Bijou started K2M Group with an Overweight rating and $28 price target. The company’s outperformance in the U.S. market over the last two years has been underappreciated, Bijou tells investors in a research note. He sees the U.S. momentum continuing in 2018 and beyond, driven by innovative new product launches and sales rep hires.
Orthofix started at buy by Cantor
Orthofix initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Craig Bijou started Orthofix with an Overweight rating and $62 price target. The analyst believes the recent share pullback provides a good entry point, especially ahead of more details on the benefit of re-domiciling to the U.S.
Tonix says Phase 2 study shows Tonmya reduces PTSD symptoms
Tonix Pharmaceuticals presented data from the Phase 2 AtEase study of Tonmya for the treatment posttraumatic stress disorder. The presentation focused on the rationale for including suicidal individuals in the clinical trial of a treatment for PTSD. “There are several examples in major psychiatric disorders in which pharmacological treatment of the underlying disorder may decrease suicidal behaviors,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix. “Individuals with military-related PTSD have an elevated risk for suicidal behaviors, and it was hypothesized that addressing underlying PTSD with Tonmya might have an impact on reducing suicidal behaviors. Suicidal individuals were included in the AtEase study as it provided for a more representative sample of the condition for evaluating the efficacy Tonmya 2.8 mg and 5.6 mg as a potential treatment for military-related PTSD.” “Taken nightly at bedtime and absorbed by a sublingual route, Tonmya is believed to reduce PTSD symptoms through improvement in sleep quality, potentially also addressing suicidal behaviors via upstream effects on sleep improvement,” Dr. Sullivan continued “While rates of suicidal ideation and behaviors were not high enough to allow meaningful statistical analyses in AtEase, these data, combined with other datasets acquired by similar methodology, may provide important new information and insights leading to better prediction of, and interventions to prevent, suicides in PTSD.”
J&J Esketamine Shows Promise in Depression Clinical Trials
The Janssen, part of Johnson & Johnson, announced results from two long-term Phase III trials of esketamine nasal spray in patients with treatment-resistant depression.
The findings were presented at the Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP) held in Miami Beach, Florida. The first trial evaluated relapse prevention in adults with treatment-resistant depression. The data showed that continuing treatment with esketamine nasal spray with an oral antidepressant beyond 16 weeks had clinically meaningful and statistically significant superiority to just an antidepressant and placebo in delaying time to relapse of depression symptoms.
The trial also showed that patients receiving the drug with an oral antidepressant had a 51 percent less risk of relapse than patients in the antidepressant-plus-placebo group.
The second study was an open-label trial to assess the long-term safety and efficacy of esketamine nasal spray for up to a year. There were no new safety signals and it was similar to those seen in previously completed short-term Phase II and III trials. From an efficacy standpoint, it also showed that esketamine nasal spray plus an oral antidepressant gave sustained improvement in depressive symptoms up to 52 weeks.
“At least 300 million people worldwide live with treatment-resistant depression, and it is important we continue to study and report the results of studies such as these two,” said Maurizio Fava, executive vice chair of the Massachusetts General Hospital (MGH) Department of Psychiatry and executive director of the MGH Clinical Trials Network and Institute (CTNI), in a statement. “The first study shows that esketamine may be beneficial in terms of extending time to relapse for patients with treatment-resistant depression, and the second provides insights related to its safety over the long-term in this patient population.”
Safety results were consistent with the previous Phase II and III trials. The most comment adverse events were metallic taste (27%), vertigo (25%), dissociation (22.4%), drowsiness (21.1%), dizziness (20.4%), headache (17.8%), nausea (16.4%), blurred vision (15.8%) and diminished sense of touch or sensation (13.2%). Most adverse events were seen on the first day of dosing and generally resolved the same day.
The company also stated, “Fifty-five (6.9%) patients experienced 68 serious treatment-emergent adverse events. Of these, five serious treatment-emergent adverse events from four subjects were assessed by the investigator as esketamine nasal spray-related. There were two deaths which the investigator determined to be unrelated to esketamine nasal spray or oral antidepressant use. Laboratory tests, physical examination, and nasal tolerability revealed no trends of clinical concern in patients treated with esketamine nasal spray for up to 52 weeks. No clinically meaningful changes in cognition were found. No cases of interstitial or ulcerative cystitis were reported.”
Esketamine is a low dose of ketamine, a drug of abuse sometimes called “Special K” and used as a horse tranquilizer. The five serious adverse events were apparently depression, delirium, anxiety and delusion, suicidal ideation and suicide attempt.
If the drug were to be approved by the Food and Drug Administration (FDA), it would be the first new pharmacotherapeutic approach to treating refractory major depressive disorder in 50 years.
Antidepressants are typically selective serotonin reuptake inhibitors (SSRIs), such as Prozac and Zoloft, or serotonin-norepinephrine reuptake inhibitors (SNRIs), likes Pristiq or Efexor. They both affect serotonin neutrotransmitters by blocking serotonin reuptake and locking it in the gap between neurons for longer than usual.
Esketamine falls into a newer class of antidepressants, and target NMDA receptors, which regulate the concentrations of the glutamate neurotransmitter in the brain. Another product with a similar method of action under development is ALKS5461, an opioid, by Alkermes That drug is currently under review by the FDA and has a target action date of January 31, 2019.
Uncovering the role of the ApoE gene in Alzheimer’s
A study conducted at the Massachusetts Institute of Technology has identified why the ApoE4 gene increases the risk of developing Alzheimer’s disease.
Image Credit: Andrii Vodolazhskyi / Shutterstock
Apolipoprotein E (ApoE) is a class of proteins involved in the metabolism of fats, including cholesterol. ApoE surrounds fats to form lipoproteins, which facilitates the transport of fats in the bloodstream. There are three variants of the gene encoding ApoE: ApoE2, ApoE3 and ApoE4.
ApoE3 is the most common variant, being present in 78% of the population, and does not appear to influence the risk of developing Alzheimer’s disease.
However, presence of the ApoE4 gene variant, which occurs in approximately 14% of people, increases the risk for Alzheimer’s disease and lowers the age of onset of the disease. In contrast, the rarest variant ApoE2 reduces the risk of developing Alzheimer’s disease by up to 40%.
It has long been known that the distribution of ApoE gene variants differs considerably among patients with late-onset Alzheimer’s disease (the most common form of the disease).
The proportion of individuals in this subpopulation carrying the ApoE4 is almost three times as high as the general population, whereas the prevalence of the protective ApoE2 gene variant is halved.
Despite this apparent link, it was not understood why ApoE4 increases the risk of developing Alzheimer’s disease.
To establish why variants of the same gene can have such different impacts on Alzheimer’s disease risk, neuroscientists conducted a comprehensive study of ApoE4 and ApoE3 in brain cells.
They discovered that the ApoE4 gene variant promoted the accumulation of the beta amyloid proteins that comprise the characteristic plaques that form in the brains of patients with Alzheimer’s disease.
ApoE4 influences every cell type that we studied, to facilitate the development of Alzheimer’s pathology, especially amyloid accumulation…ApoE4 is by far the most significant risk gene for late-onset, sporadic Alzheimer’s disease”.Li-Huei Tsai, Senior Author
The study also demonstrated that the presence of ApoE3 and ApoE4 affected the expression of hundreds of other genes and these effects were greatest in microglial cells, which are responsible for the removal of foreign matter, including amyloid proteins and bacteria.
Microglia functioned at a much slower rate when containing the ApoE4 gene variant compared with ApoE3. In addition, neurons with ApoE4 secreted higher levels of amyloid protein than neurons with ApoE3.
Furthermore, the researchers successfully reversed these effects in brain cells containing the ApoE4 gene by using gene editing technology to convert the gene into the ApoE3 variant.
The results of this study this indicate that in Alzheimer’s disease brain cells produce more amyloid protein, whilst their ability to remove it is dramatically impaired and that these effects are reversible.
It is hoped that the gene expression profiling performed will reveal potential targets for therapeutic intervention. There is the possibility that Alzheimer’s disease risk and symptoms could be reduced by converting ApoE4 to ApoE3 in individuals with high ApoE4 expression.
Weight gain may be the result of inefficient fat metabolism
Researchers from the Karolinska Institutet have shown that protracted weight gain can, in some cases, be attributed to a reduced ability to metabolise fat.
The team says certain people may need more intensive lifestyle changes if they are to decrease their risk of becoming overweight or developing type 2 diabetes.
We’ve suspected the presence of physiological mechanisms in fatty tissue that cause some people to become overweight and others not, despite similarities in lifestyle, and now we’ve found one.”Professor Mikael Rydén, Study Author
Rydén and colleagues are now working to develop a way of measuring the body’s ability to break down fat.
For the study, the researchers analysed subcutaneous fat samples taken from the abdomens of women before and after a follow-up period of approximately a decade.
As reported in the journal Cell Metabolism, they found that the ability of the fat cells to release fatty acids in the first tissue sample could be used to predict which women would have developed type 2 diabetes at the end of the study.
This fatty acid release, referred to as lipolysis, is a process the body uses to provide an energy source in muscles.
Researchers differentiate between two types of lipolysis – basal lipolysis, which is ongoing, and hormone-stimulated lipolysis, which occurs in response to an increased need for energy.
Rydén and team found that the fat cells from women who later became overweight showed a high basal, but low hormone-stimulated lipolysis that increased the risk of weight gain and type 2 diabetes by 3 to 6 times.
“It’s a bit like a car that’s at high revs but that’s lost its ability to get into gear when it needs to. The end result is that the fat cells eventually take up more fat than they can get rid of,” explains Rydén.
He says the results now need to be corroborated in larger studies and for men.
We hope to develop a clinically expedient way of identifying individuals at risk of developing overweight and type 2 diabetes, who might need more intensive lifestyle intervention than others to stay healthy.”Professor Mikael Rydén
Intuitive Surgical OKd by FDA on urological surgery system
Intuitive Surgical, Inc. (Nasdaq: ISRG), today announced a new U.S. Food and Drug Administration (FDA) clearance for the da Vinci SP surgical system for urologic surgical procedures that are appropriate for a single port approach.
The da Vinci SP system provides surgeons with robotic-assisted technology designed for deep and narrow access to tissue in the body. The ability to enter the body through a single, small incision helps surgeons perform more complex procedures. Intuitive anticipates pursuing further regulatory clearances for da Vinci SP, including transoral, transanal, and extraperitoneal applications, broadening the applicability of the SP platform over time.
“The da Vinci SP is the latest in our integrated product family that shows our commitment to improving minimally invasive surgery with technology that can positively impact patient outcomes,” said Gary Guthart, chief executive officer for Intuitive. “Our da Vinci SP compliments da Vinci X® and Xi® systems by enabling surgeons to access narrow workspaces while maintaining high quality vision, precision, and control that surgeons have come to trust from da Vinci® systems.”
The da Vinci SP system includes three, multi-jointed, wristed instruments and the first da Vinci fully wristed 3D HD camera. The instruments and the camera all emerge through a single cannula and are properly triangulated around the target anatomy to avoid external instrument collisions that can occur in narrow surgical workspaces. The system enables flexible port placement and excellent internal and external range of motion (e.g., 360-degrees of anatomical access) through the single SP arm. Surgeons control the fully articulating instruments and the camera on the da Vinci SP system, which uses the same surgeon console as the da Vinci X and Xi systems.
“Intuitive continues to bring tomorrow’s surgery today by addressing surgeon and patient needs, as well as working closely with hospitals to systematically improve the overall experience in the operating room,” said Salvatore J. Brogna, Intuitive executive vice president and chief operating officer.
Since the initial U.S. FDA clearance in April 2014 for the da Vinci SP surgical system, Intuitive invested in important platform refinements. Intuitive plans to launch the da Vinci SP surgical system in the United States in a measured fashion, with customer shipments beginning in the third quarter of 2018.
3 Possible Outcomes Of Clinical Hold On Crispr Therapeutics Sickle Cell Candidate
Shares of Crispr Therapeutics AG CRSP 6.36% fell more than 7 percent Thursday morning after the U.S. Food and Drug Administration said it placed a clinical hold on the company’s therapy.
What Happened
The FDA placed a clinical hold on the Investigational New Drug application for Crispr’s CTX001 for the treatment of sickle cell disease, Crispr and its partner Vertex Pharmaceuticals Incorporated VRTX 1.69% said in a press release. The hold is subject to the companies answering certain questions from the FDA as part of its review of the IND.
Why It’s Important
The details of the FDA’s hold are not revealed to the market, so the overall implications for Crispr aren’t fully known, Chardan’s Gbola Amusa said in a research report. Three outcomes are possible, the analyst said:
- A hold can be based on concerns over Crispr’s specificity or editing efficiency (overall sector risk).
- A hold can be based on an element of the CTX001 production or an aspect of the trial design (company-specific risk).
- A “rapid resolution” would help mitigate a negative impact on the CTX001 program and the gene editing space.
Chardan has a Buy rating on Crispr with a $72.50 price target.
What’s Next
Crispr and Vertex expect to receive additional information on the FDA’s list of questions in the “near future” and will “work rapidly” with the FDA toward a solution, the press release said.
More Drivers Killed Under the Influence of Drugs Than Alcohol
SOME 22.3 PERCENT OF fatally injured motorists who were tested for drugs tested positive for marijuana in 2016, a figure that researchers say has “increased substantially” in recent years as states have legalized the drug for recreational or medicinal use, according to a new report.
The finding, in a study released Thursday by the Governors Highway Safety Association, was one of several regarding the growing prevalence of drugs in vehicle fatalities. The report also found that 44 percent of drivers killed in automobile accidents in 2016 who were tested for drugs tested positive for one or more substances – a number that was up 28 percent from 10 years prior. That figure eclipsed the 37.9 percent who were known to have been tested for alcohol and tested positive – a figure that actually fell in the last decade, from 41 percent in 2006.
The report was intended to draw attention to the need to incorporate a drug message into programs that encourage motorists not to drive while impaired. It noted that marijuana was the most commonly found drug. Jim Hedlund, author of the study, says “marijuana use has become more normalized” as states across the country decriminalize the drug.
“If use is up, use by drivers is up,” Hedlund says.
Hedlund attributes the decline in alcohol-related deaths to the “broad societal consensus” that drunk driving is wrong. There’s a “strong societal consensus. It’s [drunk driving] is bad,” he says. “Everyone knows it’s bad.” However, this way of thinking hasn’t caught up to drug-impaired driving yet. That’s where education comes in.
“That’s the next step. Precisely to provide that education,” Hedlund says.
The report suggests that some of the strategies used to decrease drunk driving can be applied to prevent people from driving while on drugs. However, several challenges come with that. A driver can consume a vast number of drugs that would be difficult to test for. Additionally, no nationally accepted method exists for testing drug-impaired drivers, and different drugs have different effects on different people.
Among recommendations to reduce drug-impaired driving, the study points to the need to develop impairment-assessment tools, such as oral-fluid devices and marijuana breath-test instruments, to support the drug-impaired-driving prosecution process by increasing law enforcement training, authorizing electronic search warrants for drug tests, and to educate prosecutors and judges on drug-impaired driving.
Hedlund outlined additional recommendations, including raising public awareness about the impairments certain drugs have on the body, and working with pharmacists to improve communication between drugmakers and consumers.
Health-care workers are committing suicide in unprecedented numbers
As America focuses on one epidemic — the opioid crisis — another goes entirely ignored. American health-care workers are dying by suicide in unprecedented numbers. Earlier this month, a medical student and a resident at NYU medical school completed suicide less than a week apart.
My junior colleague took her life just 11 days before her 35th birthday. I had supervised her as she transitioned into practice from fellowship. She said that the way I said her name foretold if the conversation pointed to a weakness or a strength in her patient assessment. My last sight of her was as she drove off to her new job. Less than six months later, she made a life-ending choice.
A scan of her suicide note, asking that I be notified, was emailed to me. I did not show it to anyone. The news of her suicide was announced by an email in the department. We all went about our business, as if suicide by a young colleague is usual. And perhaps, in a way it is.
After all, physician suicide — and more broadly health-care worker suicide — is a huge issue in the U.S. In my own experience, I have lost six colleagues to suicide — five physicians and one physician assistant. That does not include the suicides that I have heard about through the whisper network at work.
My junior colleague was among an estimated 400 physicians who took their lives in 2016. Many physicians know more doctors than patients who have taken their lives. Physicians and nurses complete suicide more often than do average Americans; rates are even higher for women in bothprofessions. Respect, fear and love for our colleagues often leads us to list the cause of death differently on death certificates. We frequently self-medicate, so suicides may instead be listed as accidental. Phrases to describe the scope like “an entire medical school class a year” or “a doctor a day” have particularly ominous meanings for physicians.
All of the physicians that I knew who took their lives were American medical graduates, a worrisome statistic if it reflects the general trend. A full 24 percent of physicians in the U.S. are international medical graduates; my specialty, pathology, is about 40 percent international graduates.
Although a recent report of suicides among residents does not suggest differential suicide rates among international and American medical graduates, the data may be limited by the nature of the study. The number for nurse or other health-care worker suicide is unknown, since we do not even track these numbers. Earlier this year, the National Academy of Medicine released a paper to raise awareness of nurse suicide, calling for a closer look at another facet of this epidemic. The high suicide rates correlate with the high rates of depression among physicians and nurses.
Why physicians and health-care workers are more likely to complete suicide is unknown. It perhaps has to do with a work-related mental health syndrome called disengagement and burnout, which has reached epidemic proportions in health-care providers and nurses. Excessive pressures and expectations at work, paired with seemingly unattainable goals for quality and productivity as well as societal loss of trust in physicians, has led to a loss of meaning of work and of self for physicians. This is not the norm that physicians or nurses expected when we answered the call to be care-providers.
Regardless of why medical workers tend to die by suicide, there needs to be a call to arms to do something about it. Health-care organizations need to more proactively report suicide in their workforce, so we can begin to understand the drivers for suicide in health-care workers. The information needs to be granular enough to identify risks by specialty and work-type.
More immediately, institutions need to develop procedures and processes for grief recovery support for colleagues of the deceased. Many institutions shy away from even mentioning suicide at the workplace. There is concern for suicide contagion, an increased tendency toward suicide in the already predisposed upon hearing of a suicide. There is stigma to talking about suicide among leaders, and fear that it will cast a shadow on them or their organization.
But, that is the wrong response. Colleagues suffer when one of their own is lost to suicide. One spends a third of one’s life at work. Sustained relationships at work are particularly important in an environment that is so stressful. The responsibility for another’s well-being and the ever-present risk for potential harm to another from a misjudgment extracts a heavy emotional toll on health-care providers.
We perhaps even blame ourselves more when we lose a colleague to suicide. Why did I not see it? Could I have done something to prevent it? One wonders about one’s self worth and one’s ability to care for patients when one fails a colleague and friend. One institution at least, UCSD, has heard this call to action and created the Healer Education and Assessment Referral program, which promotes self-assessment for depression and provides support for all health-care workers in the setting of a coworker’s suicide. But more needs to be done — at a department level, at an institutional level and at a national level.
Postvention programs to provide support for survivors of a co-worker suicide need to be developed in the profession. Structured prevention strategies to reduce suicide need to be developed as has been done for the police and military — two other at-risk professions for suicide. Leaders need to be trained to give support to their providers, so providers can heal and continue in their job of caring for their patients, after one of theirs is lost to suicide.
Vinita Parkash M.D. is an associate professor of pathology at the Yale School of Medicine. She is a Public Voices fellow with the OpEd Project, which is an organization that focuses on increasing the number of women thought leaders contributing to key commentary forums and media outlets.
Constant Interruptions From Smartphone Can Impact Brain Chemistry
Constant interruptions from alerts and messages on your smartphone can impact brain chemistry.
It can be hard to concentrate when you’re always being diverted by your phone. It’s a pattern that scientists say creates something they call the switch cost.
Research shows constant interruptions can create a different chemistry in the brain.
“There’s this phenomenon they call switch cost that when there’s an interruption we switch away from the task that we were at and then we have to come on back. We think it interrupts our efficiency with our brains, by about 40 percent. Our nose is always getting off the grindstone, then we have to reorient ourselves,” said Dr. Scott Bea, a psychologist at Cleveland Clinic.
The new reality for many is that technology has put the brain on high alert most of the time, waiting for the next notification. Doctors say when it happens, people can get little surges of the stress hormone cortisol, which can cause the heart rate to jump, some people to get sweaty hands and muscles can get a little tight.
Being unable to check phones immediately can cause those feelings of anxiety to last until people are able to check their device. Doctors say breaking that pattern involves creating a new habit, which can take time.
“Initially, when you start trying to stay away from the technology, or confine it, you’ll be a little uncomfortable, you’ll have that fear of missing out, or a little anxiety that something is getting past you, but with practice, your brain can get used to it,” said Bea.
Breaking the habit is also difficult because experts say there can be an addictive component to technology as the brain gets rewarded with constant updates and the behavior is repeated over and over.
Homeschooling surges as parents seek safer option for children
After a gunman opened fire on students in Parkland, Florida, the phones started ringing at the Texas Home School Coalition, and they haven’t stopped yet.
The Lubbock-based organization has been swamped with inquiries for months from parents seeking safer options for their kids in the aftermath of this year’s deadly school massacres, first in Parkland and then in Santa Fe, Texas.
“When the Parkland shooting happened, our phone calls and emails exploded,” said coalition president Tim Lambert. “In the last couple of months, our numbers have doubled. We’re dealing with probably between 1,200 and 1,400 calls and emails per month, and prior to that it was 600 to 700.”
Demands to restrict firearms and beef up school security have dominated the debate following the shootings, but flying under the radar is the surge of interest in homeschooling as parents lose faith in the ability of public schools to protect students from harm.
And it’s not just the threat of school shootings. Christopher Chin, president of Homeschool Louisiana, said parents are also increasingly concerned about “the violence, the bullying, the unsafe environments.”
“One of the things we’ve seen definitely an uptick in the last five years is the aspect of violence. It’s the bullying. That is off the charts,” Mr. Chin said.
In his experience, a mass shooting won’t change the minds of parents satisfied with their children’s public-school experiences, but it can tip the balance for those already leaning toward home education.
“I think what happens with these school shootings is they’re the straws that broke the camel’s back,” Mr. Chin said. “I don’t think it’s the major decision-maker, but it’s in the back of parents’ minds.”
Brian D. Ray, president of the National Home Education Research Institute in Salem, Oregon, who has conducted homeschool research for 33 years, said school safety has increasingly become an issue for parents looking at teaching their kids at home.
He said the top three reasons that parents choose homeschooling are a desire to provide religious instruction or different values than those offered in public schools; dissatisfaction with the academic curriculum, and worries about the school environment.
“Most parents homeschool for more than one reason,” Mr. Ray said. “But when we ask families why do they homeschool, near the top nowadays is concern about the environment of schools, and that includes safety, pressure to get into drugs, pressure to get into sexual activity. It includes all of that.”
After the Feb. 14 shooting in Parkland, Florida, vows by parents to pull their kids out of school erupted on social media, and some of them apparently followed through by making contact with their local homeschool advocates.
“I talk with these people on a regular basis, and clearly after a shooting, more of them are saying, ‘Hey, we’re getting more phone calls, we’ve got more people at the beginner session asking about safety,’” Mr. Ray said.
Not everyone agrees with the homeschool response. Takisha Coats Durm, lead virtual school teacher for the Madison County Schools System in Huntsville, Alabama, said that fleeing the classroom teaches the wrong lesson.
“Even though it seems we may be protecting them, we may be sheltering them instead of teaching them to work and find a solution for the issues and not necessarily running away from them, because these things are going to happen,” Ms. Durm told WAAY-TV in Huntsville.
Her comments came shortly after the May 18 shooting at Santa Fe High School, which left 10 dead, just three months after 17 were killed in the massacre at Marjory Stoneman Douglas High School in Parkland.
Tracking the numbers
While homeschool advocates are confident their ranks are growing, pinning down the number of U.S. at-home students is a challenge, given most states don’t keep count.
A 2017 U.S. Department of Education report estimated 1.69 million homeschool students from ages 5-17 in spring 2016, using data from the National Household Education Surveys program, which mailed questionnaires to about 200,000 selected households.
Those findings would indicate that homeschooling has been flat since 2012, but Mr. Ray estimated there were 2.3 million homeschool students in spring 2016, using figures provided by the 15 states that track homeschoolers, as well as Maricopa County, Arizona.
His figure represented a 25 percent increase between 2012-16. During the same period, the U.S. school-age population grew by about 2 percent.
“My bottom-line summary is that it’s been growing at an estimated 2 to 8 percent per year, and that’s compounded,” Mr. Ray said.
In Louisiana, which does ask homeschoolers to report their kids, Mr. Chin said there were 30,134 homeschool students registered in January, up from an estimated 18,500 to 20,000 in 2011.
“Homeschooling has exploded in our state,” said Mr. Chin, who homeschools his five children with his wife in New Orleans. “If homeschoolers were their own school district in our state, we would be the sixth largest in the state.”
Texas doesn’t require registration, but Mr. Lambert, who homeschooled his four now-adult children, estimated that the state has about 150,000 families and more than 300,000 students being taught at home.
“In fact we have more students being homeschooled in Texas than we have in traditional private schools in Texas, and that’s quoted by a number of our state officials,” he said.
His organization sponsored a poll last year that found safety ranked fourth among reasons parents decide to educate their kids at home.
“I’m required by law to place my kids in a public school or private or homeschool, but the state is not accountable in terms of the safety of these children,” said Mr. Lambert. “So we get lots of calls from people saying, ‘Hey my kid’s being bullied, my kid’s being attacked, and the school either can’t or won’t do anything about it, so we’re going to take care of our child. We’re withdrawing him.’”
Like Mr. Chin, he said a highly publicized school shooting may come as the tipping point for parents already inclined to pull their kids out of the public system.
“When a shooting happens, I call it the straw that basically breaks their idea of the public schools,” Mr. Lambert said. “They’ve already been thinking about it, and now somebody gets stabbed, or another teacher beats up another kid, or another kid beats up another teacher, and they say, ‘You know what? We don’t want to be there.’”
How to stop or reduce a stutter
Everyone experiences periods in which speech is not fluent. For some, a stutter can get in the way of everyday life.
A person who stutters may only struggle with certain words or sounds. They may experience:
- blocks, in which there is a long pause before being able to say a word
- prolongations, in which certain sounds in a word are extended
- repetition of a word or part of a word
Stuttering can also have physical signs, such as movements in the face and body as a person attempts to pronounce a word.
According to the Stuttering Foundation, over 70 million people worldwide are affected. Of these, 3 million live in the United States. Males are four times more likely to stutter than females, and about 5 percent of children will go through a period of stuttering.
For people who regularly experience stuttering, and for those who experience it due to stress, several methods can help to reduce the frequency or eliminate it altogether.
Quick tips to stop stuttering
Slowing down, speaking with a rhythm, and focusing on breathing can help to reduce stuttering.
The following techniques can help a person to avoid or reduce stuttering in everyday situations, or, for example, when giving a presentation.
Focus on breathing
Before a social interaction or a period of prolonged speech, make a conscious effort to relax and breathe. Results of a study published in 2012 suggest that deep, mindful breathing helps to reduce blood pressure and increase the flow of oxygen-rich blood throughout the body. Deep breathing also reduces anxiety, which can have a powerful effect on stuttering.
Slow down
Focus on maintaining a slow rate of speech, and remember to pause between sentences and words. Continue to take deep breaths while speaking to keep anxiety under control.
Speaking too quickly can make a person feel more anxious and increase the rate of stuttering.
Avoid certain words
For many people who stutter, some words are more difficult to get out than others. Make a note of these trigger words and find alternatives to use. Also, practicing these trigger words can help to reduce the likelihood of stuttering while saying them socially. A speech therapist can advise about the best ways to practice.
Speak with a rhythm
Many people report that stuttering disappears when they sing. This is partly due to the smooth, controlled rhythm of sung language. Before speaking, imagine that you are about to sing. Also, practice putting a slight rhythm into your speech. This may help to improve speech fluency.
Visualize interactions
Many people use this technique ahead of presentations and public speaking, but it can also be useful in everyday conversations.
Anyone who is feeling nervous about speaking should try to visualize their words before they are pronounced. This can help a person to feel more prepared, in control, and confident in their communication.
Research published in 2015 suggests that imagining interactions and rehearsing speeches ahead of time can improve the fluency of speech and a person’s own evaluation of their performance.
It may also help to visualize positive outcomes of conversations. This can ease a person’s nerves and help them to avoid stuttering during interactions.
Use body movements to calm nerves
Channeling nervous energy into deliberate body movements may help to reduce stuttering. People often use this technique when speaking in public.
For a presenter, this may involve making slow movements across the stage or controlled gestures. During conversations, a person may benefit from walking or using hand gestures.
How to stop stuttering permanently
A speech therapist can help a person manage their stuttering.
For many, lots of time and effort are needed to reduce or eliminate a stutter. Over time, speech therapy and practice at home can result in drastic improvements.
Speech therapy
A speech therapist can help children and adults to manage stuttering. For some, speech therapy may be required at different times throughout life.
Initially, a therapist tests a person’s speech and assesses the severity of a stutter. Every person who stutters has a unique experience, and a therapist will ask about the impact that stuttering has on a person’s life. They will then tailor their sessions to suit the individual.
A speech therapist can also teach coping strategies to reduce anxiety around stuttering.
Practice
Practicing and rehearsing speech, especially trigger words or phrases, can help to improve a stutter. Practice should focus on:
- speaking slowly
- using compensatory strategies
- completing thoughts
- reducing tension
- taking deep breaths while speaking
It can help to practice in front of a mirror or with members of a support network.
Develop a strong support network
Often, the reactions of others can have a big impact on how a person who stutters sees themselves. It is important to be surrounded by positive, supportive people so that a person can speak without the fear of judgment.
Electronic devices
Some people who stutter benefit from a device called a speech monitor that is attached to the outer ear. This alters sound frequencies and uses delayed feedback to help a person regulate their speech.
While insurance sometimes covers the cost, these devices can be expensive. A doctor may be able to recommend more affordable options.
Many people find speech monitors helpful, but there is no guarantee that they provide permanent benefits.
Outlook
By practicing techniques and working on long-term strategies, many people can overcome stuttering.
Some children go through a phase of stuttering as part of their natural development. For others, stuttering never entirely goes away, though it may change as a person ages. For example, a person may only stutter when under pressure, such as during a presentation.
With patience and practice, most people can reduce the frequency of stuttering.
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