Advertisements

Mutations In Father’s Sperm Can Predict Children’s Autism

Image result for Genetic Mutations In Father’s Sperm

There’s no question that autism can be traced to a combination of genetic and environmental factors. One genetic contributor in particular has in recent years intrigued scientists studying autism: DNA mutations originating in fathers’ sperm.

Studies have linked autism risk to de novo mutations, or changes in DNA that arise spontaneously in sperm as the germline cell develops, or in the embryo after fertilization. Researchers estimate that such mutations might be involved in anywhere from 10% to 30% of autism cases, and that the older a father is at the time of conception, the higher the chance his sperm will result in de novo mutations that can contribute to autism spectrum disorder. In fact, with every decade of life, the number of de novo mutations in sperm doubles.

In a new study published in Nature Medicine, researchers led by a team at the University of California, San Diego (UCSD) set out to determine if they could match specific disease-causing genetic mutations in the DNA of children with autism to the same mutations in their fathers’ sperm.

The team analyzed DNA from eight sets of fathers and children. In the children, they looked for a phenomenon called mosaicism, which are genetic differences even among cells from the same person. Each time a cell divides, the process can generate mutations, or genetic mistakes—some can be harmful (for example, some can lead to cancer), but most are not because they occur outside of important genes in what are known as “DNA deserts.”

The researchers then matched these changes found in the children to those found in their fathers’ sperm. That confirmed that the de novo mutations were indeed playing some role in contributing to autism.

The researchers also determined what percentage of sperm produced by the father contained these de novo mutations. This knowledge, say the study authors, could potentially lead to a test that can help fathers of children with autism to know how likely they are to have another child affected by the condition.

Eventually, the genetic test could also tell parents-to-be if they are at increased risk of having a child with autism. The DNA sequencing technology used is basically the same as used for whole genome sequencing, and the price for that continues to drop, so this wouldn’t be an especially expensive tool.

Inhibitor CocktailsCurrently around 165 genetic mutations have been linked to autism, and conducting a deep analysis of a potential father’s sperm for some of these aberrations could let him know if he is at higher or lower risk of fathering a child who might be affected by autism. (The list of implicated genes continues to grow at a rapid pace, and at the time of the study, the scientists worked with a smaller number of culprit genetic variants).

In some of the eight fathers in the study, up to 10% of their sperm carried mutations; if these men decided to have more children, they would have the option of choosing whether they wanted to take measures to reduce the risk their children would be affected. Some, for example, might use IVF so they could screen their embryos for the mutations.

By Alice Park December 23, 2019

you wouldn't settle for one star products. why settle for a 1 star bank?

Source: Mutations In Father’s Sperm Can Predict Children’s Autism

7.15K subscribers
Part of the joy and challenge of being a parent is making sacrifices so your children can hit traditional milestones: a high school graduation, going off to college, starting a life of their own. But for some parents – like Barbara Rivera, a mother of three with two autistic children – the sacrifices are far greater and the milestones far different than what she expected. (Caregiving; Season 2, Episode 8. Original Air Date: Saturday, December 20, 2014.)

Advertisements

CBD Oil for Parkinson’s Disease

Every year in the United States, approximately 60,000 individuals are newly diagnosed with Parkinson’s disease according to the Parkinson’s Foundation (PF).[1]

The PF adds that, by the year 2020, the number of people living with this medical condition is expected to near one million in total, making it more prevalent than multiple sclerosis, muscular dystrophy, and Lou Gehrig’s disease combined.

What is Parkinson’s disease?

The American Parkinson Disease Association (APDA) defines Parkinson’s as “a type of movement disorder that can affect the ability to perform common, daily activities.”[2]

Unlike other movement disorders, Parkinson’s disease is characterized by a loss of brain cells, specifically those in the substantia nigra region. This lowers dopamine levels which causes issues related to movement regulation, thus impacting the patients’ quality of life.

Parkinson’s disease is both chronic and progressive, making this movement disorder one that is long-lasting, while also worsening as time progresses.

Also, though it typically appears after the age of 50, roughly one in ten Parkinson’s disease patients are diagnosed at a younger age. This is called Early Onset Parkinson’s.

Symptoms of Parkinson’s tend to vary from person to person and fall into one of two categories: motor symptoms and non-motor symptoms.

The APDA shares that it is the motor symptoms of Parkinson’s that typically make these typical daily movements more difficult, some of which include experiencing tremors, having stiff or rigid muscles, walking difficulties, slowness of movement (also known as bradykinesia), and postural instability.

Another motor symptom Parkinson’s disease patients tend to notice is a change in their voice. Changes in volume are common in the early stages, whereas speaking fast, crowding words, and stuttering are more prevalent in advanced stages of this disease.

Parkinson’s symptoms that don’t involve movement and are therefore sometimes missed, include:

  • Reduced sensitivity to smells
  • Trouble staying asleep
  • Increased depression and anxiety
  • Psychotic symptoms such as hallucinations and delusions
  • Fatigue
  • Weight loss
  • Excessive sweating
  • Difficulty multi-tasking
  • Harder time with organization
  • Constipation
  • Increase in urinary frequency and urgency
  • Lightheadedness
  • Reduced libido
  • Slower blinking and dry eyes

Currently, there is no cure for Parkinson’s. However, patients do have a few treatment options that can help manage this particular medical condition.

One is taking a medication to help better manage motor function. Two well-known options include Levodopa and Carbidopa, both of which can be prescribed in varying strengths and formulations.

Another common Parkinson’s treatment is therapy. For instance, physical therapy may be pursued to aid in walking and occupational therapy can help enhance fine motor skills. Speech therapy may also be required to assist with vocal issues.

Deep brain stimulation is an option as well. Approved by the U.S. Food and Drug Administration (FDA) several years ago, this treatment method is a form of surgical therapy in which an electrode is implanted in the brain, then stimulated via a device that is placed in the chest area under the skin.

The APDA further indicates that complementary medicine such as yoga and massage can also provide relief from symptoms of PD as well. Research is also finding that CBD oil can potentially help too.

CBD is short for cannabidiol, a chemical compound found within the cannabis plant that binds to cannabinoid receptors located in the body’s endocannabinoid system.[3]

CBD is different than other cannabinoids found in the marijuana plant that are known for producing the high commonly associated with medical marijuana use. This includes tetrahydrocannabinol (THC) and a similar cannabinoid, tetrahydrocannabivarin (THCV). Both THC and THCV can produce this high effect, whereas CBD does not.[4]

Additionally, our bodies do produce some cannabinoids on its own. These are called endogenous cannabinoids because they are so similar to cannabis plant compounds. CBD works by mimicking and augmenting these natural cannabinoids, providing a more therapeutic effect.

Admittedly, information in this field is still emerging, primarily because the endocannabinoid system is a relatively new finding due to the first endocannabinoid not being discovered until 1992.[5]

After the second one was identified three years later, researchers began to realize that the human body has an entire endocannabinoid system that offers positive effects related to bone density and diabetes prevention.

Since that time, research has also connected CBD with providing benefits for Parkinson’s disease.

For instance, one 2018 study published by Frontiers in Pharmacology shares that CBD helps by increasing levels of the endocannabinoid anandamide, an agonist of cannabinoid receptors.[6] It is also thought to aid in other processes found helpful for Parkinson’s patients, such as those related to serotonin receptors like 5-HT1A, peroxisome proliferator-activated receptors, and more.

Other studies shared by the National Institute of Health (NIH) have found similar results. Specifically, they indicate that the study of CBD in relation to Parkinson’s disease is especially interesting because of the direct relationship between endocannabinoids, cannabinoid receptors, and the neurons associated with this neurodegenerative disease that impacts the central nervous system.[7]

Another piece of research, this one published in the journal Cannabis and Cannabinoid Research, indicates that many clinical trials have been conducted in this area. [8] Though some have been inconclusive or controversial, others have found that CBD has positive effects on some of Parkinson’s motor symptoms.

One such study looked at 22 patients who engaged in the medical use of cannabis, which contains CBD.[9] In this case, improvements were noted in regard to tremor, rigidity, and bradykinesia 30 minutes after using medical marijuana.

Other pieces of Parkinson’s research have found that CBD can also help relieve non-motor symptoms. For instance, an open-label study—meaning that there is no placebo group, so the subjects know that they’re receiving active treatment—found that, after being taken for four weeks, CBD helped reduce psychotic symptoms.[10]

Another double-blind trial involved 119 Parkinson’s patients who were treated with either 75 mg of CBD per day, 300 mg CBD daily, or a placebo. Although researchers could not establish a statistically significant difference in motor and general symptoms scores, there were significantly different means in relation to their well-being and quality of life.[11]

The Michael J. Fox Foundation for Parkinson’s Research adds that research in this area is somewhat limited due to governmental regulations, with interpretation of results also impacted due to no standardization of CBD doses or use of products containing CBD and THC combined.[12] Therefore, it can be difficult to determine the specific effect CBD can provide to Parkinson’s patients.

Healthline reports that CBD oil has a number of scientifically-proven benefits that extend beyond those related to Parkinson’s.[13] Among them are:

One of the major concerns patients have with the use of CBD oil is whether or not it is legal. Psychology Today stresses that, while many people think that the passing of the 2018 Farm Bill legalized CBD federally, this isn’t exactly the case.[14]

Instead, the Farm Bill only legalized hemp, which is the fibrous stalk of the marijuana plant. Technically, all other parts of the plant are still illegal under the Controlled Substances Act.

What confuses the issue even more is that each state has set its own statutes regarding hemp, medical marijuana, and CBD. For instance, in New York, patients can smoke cannabis, but they aren’t banned from accessing it as a dried flower. However, if you live in Colorado, not only can individuals use medical cannabis, but children can even legally possess it on school campuses if they have status as a medical cannabis patient.[15]

Because of these variations, it is always recommended that Parkinson’s patients check the legality of cannabis use or CBD oil in their individual states before utilizing this option for treatment purposes.

[1] “Statistics.” Parkinson’s Foundation. https://parkinson.org/Understanding-Parkinsons/Statistics

[2] “What is Parkinson’s Disease?” American Parkinson Disease Association. https://www.apdaparkinson.org/what-is-parkinsons/

[3] “What is CBD?” Project CBD. https://www.projectcbd.org/about/what-is-cbd

[4] Rahn, B. “What is THCV and What Are the Benefits of This Cannabinoid?” Leafly. Feb 03, 2015. https://www.leafly.com/news/cannabis-101/what-is-thcv-and-what-are-the-benefits-of-this-cannabinoid

[5] “A History of Endocannabinoids and Cannabis.” UTT BioPharma. https://www.uttbio.com/a-history-of-endocannabinoids-and-cannabis/

[6] Peres, F.F. et al. “Cannabidiol as a Promising Strategy to Treat and Prevent Movement Disorders?” Frontiers in Pharmacology. May 2018; 9:482. Doi:10.3389/fphar.2018.00482. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5958190/

[7] Fernandez-Ruiz, J et al. “Endocannabinoids and Basal Ganglia Functionality.” Prostaglandins, Leukotrienes and Essential Fatty Acids. Feb-Mar 2002; 66(2-3):257-67. https://www.ncbi.nlm.nih.gov/pubmed/12052041

[8] Stampanoni Bassi, M et al. “Cannabinoids in Parkinson’s Disease.” Cannabis and Cannabinoid Research. Feb 2017; 2(1):21-29. Doi: 10.1089/can.2017.0002. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5436333/

[9] Lotan, I et al. “Cannabis (medical marijuana) treatment for motor and non-motor symptoms of Parkinson disease: an open-label observational study.” Clinical Neuropharmacology. Mar-Apr 2014; 37(2):41-4. Doi: 10.1097.WNF.0000000000000016. https://www.ncbi.nlm.nih.gov/pubmed/24614667

[10] Zuardi A.W. et al. “Cannabidiol for the Treatment of Psychosis in Parkinson’s Disease.” Journal of Psychopharmacology. Nov 2009; 23(8):979-83. Doi: 10.1177/0269881108096519. https://www.ncbi.nlm.nih.gov/pubmed/18801821

[11] Chagas M.H. et al. “Effects of Cannabidiol in the Treatment of Patients with Parkinson’s Disease: An Exploratory Double-Blind Trial.” Journal of Psychopharmacology. Nov 2014; 28(11):1088-98. Doi: 10.1177/0269881114550355. https://www.ncbi.nlm.nih.gov/pubmed/25237116

[12] Dolhun, R. “Ask the MD: Medical Marijuana and Parkinson’s Disease.” The Michael J. Fox Foundation for Parkinson’s Research. May 02, 2018. https://www.michaeljfox.org/foundation/news-detail.php?ask-the-md-medical-marijuana-and-parkinson-disease-a

[13] Kubala, J. “7 Benefits and Uses of CBD Oil (Plus Side Effects).” Healthline. Feb 26, 2018. https://www.healthline.com/nutrition/cbd-oil-benefits

[14] Pierre, J. “Now that Hemp is Legal, Is Cannabidiol (CBD) Legal Too?” Psychology Today. Jan 02, 2019. https://www.psychologytoday.com/us/blog/psych-unseen/201901/now-hemp-is-legal-is-cannabidiol-cbd-legal-too

[15] “Legal Information By State & Federal Law.” Americans for Safe Access. https://www.safeaccessnow.org/state_and_federal_law

Dr. Andrew Colucci

By: Dr. Andrew Colucci

Doctor of Medicine (M.D. cum laude) from Boston University School of Medicine in 2012 – Dr. Colucci is currently a radiologist in MA

Source: CBD Oil for Parkinson’s Disease

19.5K subscribers
Does medical marijuana help Parkinson’s symptoms? Rachel Dolhun, MD, movement disorder specialist and vice president of medical communications at The Michael J. Fox Foundation, answers this and other common questions about medical marijuana and Parkinson’s disease. The “Ask the MD” series is intended as an educational resource for people with Parkinson’s and their loved ones. Please consult with your personal healthcare provider to address individual medical questions. The Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson’s today. https://www.michaeljfox.org We gratefully acknowledge the Steering Committee members of our Patient Disease Education Consortium in conjunction with The Albert B. Glickman Parkinson’s Disease Education Program and Charles B. Moss Jr. and family, whose sponsorship allows us to create and distribute materials, while preserving our track record of efficiency in stewarding donor-raised contributions for maximum impact on Parkinson’s drug development. Sponsorship support does not influence MJFF’s content perspective or panelist selection. Note: Tap cc in the lower right corner of the player to enable auto-generated captions for the video.

Smartphones Have Led to a Spike in Head and Neck Injuries As People Walk, Drive, Text and Play Games

The number of people who have injured their necks or heads while using using cell phones has spiked over the past two decades, with a sharp increase following the release of the iPhone, research has revealed.

Most people got hurt because they were distracted by their cell phones, and while in the home according, to the study published in the journal JAMA Otolaryngology–Head & Neck Surgery.

The researchers used the National Electronic Injury Surveillance System (NEISS) database on emergency room visits from approximately 100 U.S. hospitals to carry out the study.

Of the 2,501 incidents occurring between January 1998 and December 2017, 37.6 percent involved patients aged between 13 to 29-years-old, with pre-teens most at risk. Of the total, 55 percent were female, 38.8 percent white.

The majority of patients hurt their head, followed by the face, including the eye and nose area, and lastly the neck. Lacerations were the most common injury, followed by contusions or abrasions and internal organ injuries—mostly traumatic brain injuries. For instance, some were hit in the face, or were harmed when batteries exploded. Some suffered concussion.

Head and neck injuries related to phones were relatively rare up until 2007, when rates shot up following the release of the Apple iPhone, followed by a much steeper rise to a peak in 2016, the researchers found.

Based on the 2,501 cases, the team estimated a total of 76,043 such injuries likely occurred across the U.S. between 1998 and 2017. Of those, an estimated 14,150 involved people who were distracted. That included 90 playing Pokémon Go.

A further 7,240 people were driving, 1,022 texting, and 5,080 patients were walking and using a smartphone.

Around 96 percent of Americans own a cell phone, according to the researchers.

Despina Stavrinos, associate professor of psychology at the University of Alabama at Birmingham who did not work on the study told Newsweek she wasn’t surprised by the findings “given how pervasive cell phones are in our everyday lives.”

She said as the numbers were taken from a database on medical settings, the findings could be an underestimate of the problem.

“A significant portion of the injuries were to children and adolescents, suggesting parents play an important role in educating their children on safe phone practices. Policy and behavioral interventions should continue to consider ways to prevent cell phone use in transportation settings,” said Stavrinos.

“Most of the injuries in this study occurred at home; however, a smaller yet significant portion occurred in traffic environments. Distracted walking, bicycling, and driving are common and extremely dangerous activities among youth that increases their risk of injury,” said Stavrinos, who co-authored a paper on that topic.

“Cell phones offer many advantages, but also pose risks if they are not used properly. This is definitely the case when it comes to using phones while driving or walking.”

By

Source: Smartphones Have Led to a Spike in Head and Neck Injuries As People Walk, Drive, Text and Play Games

1.47M subscribers
Bending and staring down at our phones for several hours, increases the stress on our neck and spine, leading to neck and back pain. Experts refer to this condition as text neck and it can eventually lead to serious consequences. Also, at night, when we stare at our smartphones, the light emitted from their screens makes our brain think that it is still daytime. So, our brain does not produce the sleep hormone melatonin, causing us to stay awake for long hours and thus, disturbing our circadian rhythm which regulates our every day bodily functions. This can lead to obesity, diabetes, cancer, etc. An interesting fact is that smartphone addiction has given rise to a new phobia called Nomophobia, short for no mobile phone phobia. It is basically the fear or anxiety of being without our phone.

These Brands May Be to Blame for Vaping-Related Illnesses

Man smokes an electronic cigarette in town .

Dank Vapes seem to be associated with many cases of e-cigarette and vaping-product associated lung injury (EVALI) popping up across the country, the U.S. Centers for Disease Control and Prevention (CDC) announced Friday.

The CDC has already pointed to products containing the marijuana compound THC—particularly those tainted by the additive vitamin E acetate—as a likely cause of many of the nearly 2,300 EVALI cases and 48 deaths reported during the outbreak. Now, for the first time, the agency has released national data about specific brands used by individuals before they got sick.

More than half the 482 hospitalized EVALI patients who provided specific product information to the CDC reported using products from Dank Vapes, which the CDC calls “a class of largely counterfeit THC-containing products of unknown origin.” An Inverse investigation found that Dank Vapes is not a legitimate company, but rather a label often affixed to counterfeit products produced by unknown makers. “They act like a cannabis company, but they actually don’t exist. They’re in the packaging industry,” a cannabis industry entrepreneur told Inverse.

Health advocates are encouraging Donald Trump to move forward with a federal ban on thousands of flavors used in e-cigarettes. The CDC’s investigation points to the nebulous network’s reach. Patients in every region said they had used Dank Vapes products, though they were used a bit more often in the Midwest, Northeast and South than the West. The CDC has already reported evidence that Dank Vapes products were associated with illnesses in Illinois and Wisconsin.

Other vaping brands used by patients in the CDC’s report include TKO, Rove, Smart Cart, Kingpen and Cookie, many of which were used by more people in the West than anywhere else. TIME could not immediately reach any of the companies for comment.

Though the data helps advance the CDC’s investigation, there are still many unanswered questions. The nearly 500 patients included in the latest report said they had used 152 different products in all, making it difficult to nail down which ones are the possible sources of illnesses—especially since some patients use e-cigarettes from multiple brands.

It’s also not totally clear whether THC-containing products are to blame for all cases of EVALI. Eighty percent of the 1,782 hospitalized EVALI patients for whom the CDC has information about product use said they had vaped THC in the three months before symptoms (35% exclusively), but 54% also said they had used nicotine (13% exclusively). Smaller numbers also reported additionally or exclusively using products containing CBD, a non-psychoactive marijuana compound.

There was some good news in the report, however. The CDC says the number of EVALI diagnoses has declined each week since mid-September, suggesting that the outbreak may be approaching its end.

By : Jamie Ducharme

Source: These Brands May Be to Blame for Vaping-Related Illnesses

 

Study: Women With Dense Breast Tissue May Benefit From Regular MRIs

Breast cancer. Coloured sagittal magnetic resonance imaging (MRI) scans of a breast of a 39- year-old woman with breast cancer. The cancer (orange) has been highlighted by the injection of a gadolinium contrast medium, a contrast medium suitable for use in MRI scans. The front of the breast is at left in each scan, in these views from the side. The cancer is a ductal carcinoma, a carcinoma of the ducts that channel milk to the nipple. Ductal carcinoma is a common form of breast cancer. Breast cancer, the most common cancer in women, can be treated by surgical removal of the affected breast, often combined with radiotherapy and chemotherapy.

While there has been some controversy over when women should start getting mammograms, all experts agree that screening is an important first step in detecting breast cancers and treating them early. But for some women, that’s not enough. For the approximately 40% of women with dense breast tissue, and especially the 10% with extremely dense tissue, cancer cells are harder to detect, since the denser tissue can mask small growths. In addition, dense breast tissue itself is also a risk factor for developing cancer.

There’s been debate among experts over whether these women should have additional screening, on top of mammograms. A new study published in the New England Journal of Medicine provides the strongest data yet to support adding MRI screening to mammograms for women with extremely dense breast tissue.

Previous studies have compared rates of breast cancer in women getting mammograms alone to rates in those getting mammograms and MRI, but it hasn’t been clear that the “cancers” identified in these data sets were actually cancer. That’s because some breast cancers are what experts consider a pre-cancerous stage, known as ductal carcinoma in situ, meaning they may not grow or progress into disease.

That’s led some doctors to worry over potential over-diagnosis of breast cancer, which can lead to over-treatment of lesions that may never develop into tumors. The U.S. Preventive Services Task Force, which attempts to find answers to controversial health questions, has concluded that there is not enough evidence to advise women about the benefits or harms of adding other breast-cancer testing on top of mammograms.

In the new study, Carla van Gils, professor of clinical epidemiology of cancer at the University Medical Center Utrecht, attempted to address this concern by focusing on how many actual cancers the combination of mammogram and MRI can help to detect in women with dense breast tissue. Taking advantage of the fact that the Netherlands has a national cancer registry that includes about 99% of all diagnoses in the country, she and her team studied more than 40,000 women with extremely dense breast tissue, who were randomly assigned to screening with mammography alone or both mammography and MRI.

Each woman in the study was screened once in the two year study period (following the Netherlands’ screening guidelines that call for mammograms every other year for women over 50). Van Gils and her team analyzed how many invasive cancers were detected in between screenings, which serves as a measure for how effective the MRI was in detecting what the researchers call interval cancers—those diagnosed after a negative mammogram, and before the next mammogram was scheduled.

“If we can prevent those, we know at least we are preventing clinically relevant tumors,” says van Gils, “and not just over diagnosing.” They found that the rate of such cancers in women getting both types of imaging was 2.5 per 1,000 screenings, compared to 5 in 1,000 for women just getting mammograms.

The idea is that supplementing mammograms with MRI in the initial screening led to earlier detection of tumors that the mammograms missed which in turn contributed to lower cancer rates during a second screening, because presumably the women are seeing their doctors when suspicious growths are found and getting them treated.

The data do not confirm that combining mammograms and MRIs can lead to fewer deaths from breast cancer; that’s something van Gils will study in coming years. But documenting the reduction in cancer detected in between screenings is an important first step in showing the value of supplemental MRI for women with extremely dense breast tissue.

It also supports the reasoning behind a law passed earlier this year in the U.S. requiring that mammogram reports include an assessment of the density of women’s breast tissue, along with an explanation for why that might make mammogram results more difficult to interpret.

Van Gils notes that the results of her study aren’t robust enough yet to recommend that all women with dense breast tissue (even those with extremely dense breast tissue) should get MRIs on top of their regular mammogram screenings. For one, lowering the rates of false positives for MRIs is still a challenge; training radiologists to become more adept are reading images of dense breast tissue could help, as could applying machine learning technology to pick up subtle changes that even the best-trained human eyes cannot.

That said, if longer-term studies—enabling doctors to compare MRI readings over time to track the growth of lesions—also confirm that supplementing mammograms with MRI can lower death rates from breast cancer, it could push experts to change guidelines and give women firmer advice on how best to manage their cancer risk.

By Alice Park

November 27, 2019

Source: Study: Women With Dense Breast Tissue May Benefit From Regular MRIs | Time

351K subscribers
Dr. Amy Degnim, surgeon at Mayo Clinic, explains what dense breast tissue is and different types of imaging that may be recommended for breast cancer screening. To learn more about breast cancer screening, visit: https://mayocl.in/31AZAoC To request an appointment at Mayo Clinic, visit: https://mayocl.in/2QwVBoc Dense breast tissue makes breast cancer screening more difficult due to its appearance on a mammogram. Other imaging used for screening includes 3D mammogram, breast MRI, breast ultrasound and molecular breast imaging (MBI). More health and medical news on the Mayo Clinic News Network. https://newsnetwork.mayoclinic.org/

Regulation & Reimbursement Strategies Should Not Get In the Way of ‘Smart’ Electronic Skin Patches

Recent IDTechEx research in their report: Electronic Skin Patches 2019-2029, has revealed significant opportunities in the development and use of electronic skin patches, with over $7.5bn in revenue made from the technology in 2018 and a growth forecast of over $20bn per year over the next decade.

However, it also shows that reimbursement and regulatory consideration aren’t necessarily keeping pace. James Hayward, Principal Analyst at IDTechEx, highlights the dangers of a closed market driven by regulation and reimbursement strategies which favour devices for simplicity and cost rather than effectiveness; deterring new entrants.

Electronic skin patches are wearable products attached to the skin of a user incorporating sensors, actuators, processors and communication technology, allowing the device to connect to the internet to become ‘smart’. Skin patches are one of the latest waves in health monitoring; their non-intrusive design meaning they are comfortable and discrete. Unsurprisingly, interest in electronic skin patches has soared, driven by significant hype and market growth around wearable devices starting in 2014.

A number of significant applications of electronic skin patches are now having a profound impact on health and quality of life. Some of the foremost use cases center around healthcare and medical applications, while the consumer health market is another early adopter. As such, several product areas, particularly in diabetes management and cardiovascular monitoring, have grown exponentially to create billions of dollars of new revenue each year for the companies at the forefront of this wave.

Cardiovascular monitoring faces reimbursement and competitive roadblocks

Alongside this growth has come the need for forward-thinking regulation and reimbursement, especially given the life-changing medical context of their applications. Following regulatory approval, the funding of medical devices can come from different sources, including government-led reimbursement schemes. These provide funding for medical devices defined within certain categories according to central definitions and understandings of the performance and cost of the device. While systems do vary by country, it is typical for central procedural terminology to be linked to reimbursement amounts for each device.

Take cardiovascular skin patches for example, which exist in a highly competitive landscape alongside consumer wearables such as watches and chest straps (which provide cardiac data but with limited medical usefulness due to a lack of medical approval) as well as cardiac implants which offer a more accurate but less safe approach.

Effectiveness must have a role to play in future developments 

Electronic skin patches for cardiovascular monitoring must strike a compromise between data quality and patient comfort. A patient can remain active while wearing the device, minimizing additional issues caused by remaining in a hospital bed for too long. However, they also typically produce simpler data sets than the full 12-lead standard monitor and offer less control over the quality of the data produced. These competitive landscapes drive positive product development but it is often the central regulatory and funding bodies that have the power to drive change.

Previously, these mobile cardiac telemetry products have benefited from a favorable reimbursement scenario in the US, defined under a Category 3 CPT code for “extended Holter monitoring”. This code entitles them to twice the amount of reimbursement as “event monitoring” and more than eight times the amount afforded to generic “Holter monitoring” (both Category 1 CPT codes). If the reimbursement situation were to change, the entire revenue structure for these devices will change with it. Should reimbursement strategies be allowed to shape developments rather than consumers and effectiveness?

Diabetes management reveals a confusing system

One of the biggest revenue generators in the electronic skin patches market has been continuous glucose monitoring (CGM) for diabetes management, which posted annual revenues of over $2.5bn in 2018. The US Food and Drug Administration (FDA) has given four companies approval to sell CGM products, three of the four companies offer a skin patch with a small needle to test glucose levels in interstitial fluid. Only one organisation offers a subcutaneous implant which is then read using a skin patch as a communication hub. In such a closed market, regulations and reimbursements are shaping its course.

The three large players offering a needle-based skin patch have benefited from multiple geographies now offering partial or full reimbursement for CGM products under national healthcare schemes. Yet each of the three products is treated under a single regulatory category and receive the same reimbursement per device, regardless of performance, longevity or functionality. This opens up the potential for a closed market which favours devices because of simplicity and cost rather than effectiveness.

The fourth player is a new market entrant with lower revenue but offers a much longer-lasting CGM solution with significant differentiation from its rivals, but because of limited regulation and reimbursement, however, it may struggle to break the market stranglehold from larger players with cheaper solutions.

New entrants need to be encouraged

This reimbursement and regulatory environment provide an even bigger barrier to entry for new and innovative electronic skin patches. If the product is to be offered as a medical device, it must go through regulatory approval processes, either showing equal performance to existing equivalents or going through a de novo process to prove its efficacy and safety.

These hurdles often result in new electronic skin patch devices being pushed towards the consumer health market, where regulatory roadblocks aren’t as stringent but offer less long-term returns than in direct healthcare. This is already proving to be the case with the promising area of temperature sensing for fever and fertility monitoring, as well as other patient monitoring devices.

Healthcare Sensors Cambridge Event

This is exactly why IDTechEx has been tracking the emergence of electronic skin patches and the reimbursement and regulatory landscape back to 2010, across 26 application areas and over 100 market players, in its report Electronic Skin Patches 2019-2029. The report forecasts the market through 2019-2029 and aims to help innovative healthcare organisations make more informed business decisions before deciding how to roll-out one of the hottest technologies in patient monitoring.

In addition to detailed reports on this topic, IDTechEx are hosting an event: Healthcare Sensor Innovations 2019, in Cambridge, UK which is a conference and table-top exhibition focusing on the latest developments in the use of wearables and sensors in continuous monitoring of individuals and point-of-care diagnostics.

Register here: www.IDTechEx.com/Cambridge


About the Author

James Hayward, Principal Analyst at IDTechEx. James is a Principal Analyst at IDTechEx. Joining in 2014, he initially developed IDTechEx’s wearable technology platform. He now oversees a team of analysts across varied topic areas, as well as oversight over the wearable technology research efforts.

Featured Image: Peshkova

Source: Regulation and reimbursement strategies should not get in the way of ‘smart’ electronic skin patches – TechNative

54.9K subscribers
Engineers at the University of California San Diego have developed a flexible wearable sensor that can accurately measure a person’s blood alcohol level from sweat and transmit the data wirelessly to a laptop, smartphone or other mobile device. The device can be worn on the skin and could be used by doctors and police officers for continuous, non-invasive and real-time monitoring of blood alcohol content. The device consists of a temporary tattoo—which sticks to the skin, induces sweat and electrochemically detects the alcohol level—and a portable flexible electronic circuit board, which is connected to the tattoo by a magnet and can communicate the information to a mobile device via Bluetooth. Lots of accidents on the road are caused by drunk driving. This technology provides an accurate, convenient and quick way to monitor alcohol consumption to help prevent people from driving while intoxicated. The device could be integrated with a car’s alcohol ignition interlocks, or friends could use it to check up on each other before handing over the car keys. Blood alcohol concentration is the most accurate indicator of a person’s alcohol level, but measuring it requires pricking a finger. Breathalyzers, which are the most commonly used devices to indirectly estimate blood alcohol concentration, are non-invasive, but they can give false readouts. For example, the alcohol level detected in a person’s breath right after taking a drink would typically appear higher than that person’s actual blood alcohol concentration. A person could also fool a breathalyzer into detecting a lower alcohol level by using mouthwash. Recent research has shown that blood alcohol concentration can also be estimated by measuring alcohol levels in what’s called insensible sweat—perspiration that happens before it’s perceived as moisture on the skin. But this measurement can be up to two hours behind the actual blood alcohol reading. On the other hand, the alcohol level in sensible sweat—the sweat that’s typically seen—is a better real-time indicator of the blood alcohol concentration, but so far the systems that can measure this are neither portable nor fit for wearing on the body. Now, UC San Diego researchers have developed an alcohol sensor that’s wearable, portable and could accurately monitor alcohol level in sweat within 15 minutes. News Source: http://jacobsschool.ucsd.edu/news/new…

Best Stress Medication? This Doctor Says It’s RediCalm Doctor Formulated

The Biological Cause of Anxiety

Scientists have identified why it can be so difficult to escape the cycle of negative behavior.Your mood is strongly influenced by two key neurotransmitters, GABA and serotonin. When levels are low, anxious thoughts fill your mind and you don’t you feel like yourself.

But promoting healthy levels of GABA and serotonin helps restore your mind to a state of calm. More importantly, this feeling is maintained even when you are faced with a stressful situation.

Prescription medication is often considered the only treatment for anxiety. However, a new group of doctors are advocating for a more natural approach.

“Our Research Confirms a Natural Approach Is Best”

Dr. Hoffman reveals new clinical evidence supporting the use of natural remedies for anxiety relief.

Ronald Hoffman, MD, has been practicing for over 30 years in New York City and is an internationally recognized expert in integrative medicine. He and his team of researchers have been investigating the most effective alternative remedies to boost levels of GABA and serotonin naturally.

“After months of research and testing, we arrived at a formula of 5 natural ingredients that outperformed all others in terms of safety and effectiveness,” Dr. Hoffman states. “Following the results of the placebo-controlled clinical study, we decided to release the formula to the public.”

Ashwagandha

Passion Flower

L-Theanine

Lemon Balm

5-HTP:

The Clinical Study

  • More than 2 out of 3 participants experienced anxiety relief within just 30 minutes of taking RediCalm.
  • More than 95% of participants felt improvement in their overall anxiety level over the course of 30 days.
  • None of the participants reported any negative side effects.
  • Every participant said that they would recommend RediCalm to a friend or relative.

Each of the ingredients in the RediCalm formula has a long-standing history of safety and effectiveness.

RediCalm can be taken with most prescription and over-the-counter medications. When taken as directed, RediCalm is safe, poses no short-term or long-term health risks, and is not addictive or habit-forming.

As with any dietary supplement, it is recommended that you consult with your doctor or healthcare provider before taking RediCalm. Please visit our Safety Facts page for more information about contraindications and possible side effects.

* For more details, click here to view the complete results of the study.

Source: Clinically Proven Natural Stress Relief

Stress Changes The Brain, And This Could Be How It Happens

The results of a new brain imaging study may have just answered a big question about how stress changes the brain. Using a combination of genetic editing and brain scanning in mice, researchers found that stress triggers a chemical cascade that radically changes how brain networks communicate, and the results could sharpen our understanding of anxiety disorders in humans.

Breaking down the research

Stress serves an important purpose in preparing us to react to danger. Anything the brain perceives as threatening triggers multiple brain networks to synchronize and communicate, all in just a fraction of a second. With systems humming, we make immediate decisions to survive the threat.

But what facilitates all of those brain networks to connect and communicate? That’s been a difficult question to answer in the human brain, because doing so would require examining brain function during the split-second window of facing a threat.

Enter our friends the mice to help solve the problem. Researchers followed a trail of previous studies and zeroed in on the neurotransmitter noradrenaline (aka norepinephrine, a chemical that floods the brain during stress) as a likely facilitator of brain-network connectivity.

The twist was that they had genetically manipulated the rodents’ brains to allow for selectively controlling when noradrenaline was released (not possible in human brains). While controlling the chemical faucet, they also scanned the mouse brains using fMRI to see what would happen.

And what happened, it turns out, was pretty amazing. The release of noradrenaline “rewired” the mouse brains, allowing different brain networks to instantly cross-communicate. But the neurotransmitter wasn’t just facilitating communication, it was restructuring neural connections beyond anyone’s expectations.

“I couldn’t believe that we were seeing such strong effects,” said the study’s first author Valerio Zerbi, a brain imaging specialist from the University of Zurich.

The researchers found the strongest rewired effects in brain areas responsible for processing sensory stimuli (auditory and visual, for example), and in the amygdala, the epicenter of the brain’s threat response system.

What does this mean for us?

It’s the part about threat response that may hold the most promise for better understanding what stress does to our brains.

Allowing for the fact that this was research in mice, the particular dynamic studied here is probably quite similar between us and our rodent counterparts. If noradrenaline rewires the human brain as it appears to rewire the brains of mice, it’s possible the long-term effects of stress are more profound than we’ve realized.

Previous research has linked the flood of noradrenaline to changes in brain connectivity, but it seems likely we’ve underestimated the effects, especially in the small but powerful part of our brain sitting at the center of anxiety disorders: the amygdala.

At a minimum, this research opens new doors for better understanding how both acute and chronic stress effects the brain, and could enlighten new ways of deconstructing anxiety conditions, now the most prevalent mental health disorders worldwide. The study was published in the journal Neuron.

Follow me on Twitter. Check out my website or some of my other work here.

David DiSalvo is the author of the best-selling book “What Makes Your Brain Happy and Why You Should Do the Opposite”, which has been published in 15 languages, and the books “Brain Changer: How Harnessing Your Brain’s Power to Adapt Can Change Your Life” and “The Brain in Your Kitchen”. His work has appeared in Scientific American Mind, Forbes, Time, Psychology Today, The Wall Street Journal, Slate, Esquire, Mental Floss and other publications, and he’s the writer behind the widely read science and technology blogs “Neuropsyched” at Forbes and “Neuronarrative” at Psychology Today. He can be found on Twitter @neuronarrative and at his website, daviddisalvo.org. Contact him at: disalvowrites [at] gmail.com.

Source: Stress Changes The Brain, And This Could Be How It Happens

How Will The Failure Of Biogen’s Alzheimer’s Drug, Aducanumab, Impact R&D?

uncaptioned image

Photographer: Scott Eisen/Bloomberg

© 2016 Bloomberg Finance LP

The landscape of experimental Alzheimer’s disease (AD) drugs is strewn with failures, so much so that it has been referred to as “an unrelenting disaster zone”. Recognizing the greatly increasing number of patients with this disease, many biopharma companies have invested a lot of resources in attacking this problem, only to be turned away in late stage studies as happened to Merck with its BACE inhibitor, verubecestat, and Lilly with its beta-amyloid antibody, solanezumab.

Now add Biogen to the list of companies that have failed in this arena. Its drug, aducanumab, partnered with Eisai, was believed to be better in removing beta-amyloid from the brain than any agent previously tested. Many have hypothesized that beta-amyloid causes the formation of damaging clumps of debris in the brain leading to AD. Unfortunately, Biogen halted a major clinical trial with aducanumab due to a futility analysis showing that the drug doesn’t work.

This is a terrible result for Alzheimer’s patients who had hoped that this was the drug that would finally succeed in treating AD. But the demise of aducanumab is also disastrous for Biogen which had expended an enormous amount of resources into this program, likely at the expense of other opportunities. It was a risky bet and one for which Wall Street has delivered a punishing blow. Biogen’s stock dropped by nearly 30% shortly after announcing the disappointing aducanumab results.

How is Biogen going to respond? As John Carroll has reported, many industry analysts believe that there aren’t many gems in the Biogen pipeline that can make up for the loss of this potential blockbuster. In predicting Biogen’s next steps, perhaps there are some learnings from another such pipeline failure – that of Pfizer’s torcetrapib.

Torcetrapib was the first of a class of compounds known as CETP inhibitors, drugs that both raised HDL-cholesterol and lowered LDL-cholesterol. A CETP inhibitor had the potential to remodel a heart patient’s lipid profile thereby greatly reducing his risk of a heart attack or stroke. There was tremendous excitement generated in this potential breakthrough treatment, not just in Pfizer but also among cardiologists and heart patients. In fact, internal commercial analyses predicted annual sales in excess of $15 billion. However, as happened with aducanumab, on December 4th, 2006, Pfizer announced that torcetrapib failed its long-term clinical study. The drug was dead. The Wall Street reaction was swift, albeit not as dramatic as Biogen’s experience. Pfizer stock dropped 10% as a result of this news.

Internally, the Pfizer reaction was intense. Torcetrapib was supposed to be the blockbuster that would drive growth into the next decade. Its loss created an enormous hole. Pfizer CEO Jeff Kindler responded in a couple of ways. First, he decided to “right size” R&D in relation to lower expected future revenues. In effect, hundreds of millions of dollars needed to be cut from R&D. Pfizer’s R&D budget had already undergone major portfolio adjustments and reorganizations over the previous five years due to the acquisition of Warner-Lambert Parke-Davis in 2000 followed by the acquisition of Pharmacia in 2004. Meeting the new R&D budget targets weren’t going to be achieved by simple cuts; rather, major research sites had to be closed and jobs had to be eliminated. Gone were R&D sites around the world including those in France, Japan and, most significantly, the iconic laboratory in Ann Arbor, Michigan.

But budget cuts weren’t going to be enough for Pfizer to meet its desired goals. The company began assessing major M&A opportunities and in 2009 it acquired Wyeth for $68 billion leading to yet another round of reorganizations and portfolio reshuffling. The ripple effect of the torcetrapib demise was felt by the entire company and lasted for a number of years.

So, how will Biogen respond? Undoubtedly, there will be budget cuts. In addition, perhaps Biogen will look at its R&D portfolio and give a higher priority to those programs that have the potential to deliver revenues in the short term. There might also be a push to drop programs deemed to be very risky or where the proof-of-concept requires long, expensive clinical trials. Finally, it wouldn’t be surprising to see Biogen become aggressive in their M&A activities. But make no mistake. The death of an important drug like aducanumab will have both a short and a long term effect on Biogen as a company and especially on R&D.

I was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, and Asi…

Source: How Will The Failure Of Biogen’s Alzheimer’s Drug, Aducanumab, Impact R&D?

Open Innovation In Japan Breaks New Ground In The Operating Room

Yoshihiro Muragaki (left) and Jun Okamoto (right) of Tokyo Women's University's Institute of Advanced Biomedical Engineering and Science

Yoshihiro Muragaki (left) and Jun Okamoto (right) of Tokyo Women’s Medical University’s Institute of Advanced Biomedical Engineering and Science pose in a version of the Smart Cyber Operating Theater (SCOT).JAPAN BRANDVOICE

Imagine undergoing surgery on a robotic bed that can automatically help perform a magnetic resonance imaging (MRI) scan while an artificial intelligence (AI) system actively supports surgeons by suggesting various procedures. It sounds like a scenario from a Hollywood movie, but it’s reality in Japan.

Doctors at the Tokyo Women’s Medical University – Waseda University Joint Institution for Advanced Biomedical Sciences (TWIns) recently performed a groundbreaking brain surgery to treat essential tremor, a neurological disorder. It was the first clinical use of the latest version of the institution’s Smart Cyber Operating Theater (SCOT). Hyper SCOT, as it’s known, brings robotics and AI into the operating theater so that patients can have better post-surgical outcomes. It’s an impressive example of the many forms of open collaboration driving innovation in Japan.

A new frontier in surgery

Walking into the Hyper SCOT operating room at Tokyo Women’s Medical University, one gets the feeling of entering Sick Bay aboard the starship Enterprise from Star Trek. Silver doors slide open to reveal a sleek white room illuminated by variable-color lights. In the center are a pair of robots: an operating bed that swivels to position a patient under a large MRI scanner nearby, and a dual-armed industrial-style robot that can support a surgeon’s arms while operating. On the wall are high-resolution images of a patient’s brain. Surgeons can gesture to zoom in or change the images’ orientation, a feature inspired by the Tom Cruise film Minority Report.

As a next-generation operating room, SCOT can reduce risks and increase benefits for patients, says Muragaki.

As a next-generation operating room, SCOT can reduce risks and increase benefits for patients, says Muragaki.JAPAN BRANDVOICE

Hyper SCOT is designed to transform surgery from an analog process, where standalone equipment is not connected, into a digital process where data are shared. It can support surgical teams by providing them with a rich stream of data from networked medical tools as well as AI-powered advice on surgical options. SCOT also aims to improve precision by helping brain surgeons accurately navigate to a tumor site. Although MRI had only been available to surgeons before an operation, Hyper SCOT would enable them to get scans during the procedure, which could dramatically improve outcomes.

“If we have many kinds of information, we need some kind of strategy desk, like Mission Control at NASA,” says SCOT project leader Yoshihiro Muragaki, a professor in Tokyo Women’s Medical University’s Institute of Advanced Biomedical Engineering and Science. “Our moonshot is to make new eyes, brains and hands for surgeons. With SCOT, we can perform precision-guided therapy.”

Okamoto demonstrates a SCOT brain imagery gestural interface inspired by the film Minority Report at Tokyo Women's Medical University.

Okamoto demonstrates a SCOT brain imagery gestural interface inspired by the film Minority Report at Tokyo Women’s Medical University. JAPAN BRANDVOICE

A neurosurgeon himself, Muragaki conceived of the SCOT project and has spearheaded it since its inception in 2000. Back then it was known as the Intelligent Operating Theater, a version now known as Classic SCOT. Supported by a grant from the Japan Agency for Medical Research and Development (AMED), the system began as an initiative to enhance interoperability among devices used in the medical theater, but the development team later added features such as multiple surgery cameras that can send imagery to remote consultants, usually senior surgeons. These advisors have a bird’s-eye view of the action as well as near-real time data streams of patients’ vital statistics. Since 2000, the technology has been used in some 1,900 cases, mostly brain surgeries. MRI has been key in detecting residual tumor tissue that escaped surgeons’ notice during operations.

“Even under a microscope, it’s very difficult to detect where brain tumor tissue ends and healthy tissue begins,” says Muragaki. “That’s why we need MRI during surgery. It’s a very powerful tool for removing tumors. But that also means we can only use MRI-compatible devices in the operating room and we must choose them carefully.”

Fruits of teamwork

With over 100 researchers, SCOT is the result of a complex collaboration between academia and the private and public sectors. Aside from the two universities in TWIns, Muragaki and colleagues are working with Hiroshima University and Shinshu University, where versions of SCOT are being evaluated in clinical settings. High-tech companies are also helping to develop SCOT, including Hitachi, Canon Medical, and Air Water. Another participant is Denso. It developed a medical-equipment middleware called OpeLiNK that is based on factory automation technology as well as ORiN, a platform created with the support of the New Energy and Industrial Technology Development Organization (NEDO), a leading Japanese state-backed research center. Orchestrating all these players was essential in creating SCOT.

Another major benefit of SCOT is the ability to obtain scans using an MRI machine (right) during surgery.

Another major benefit of SCOT is the ability to obtain scans using an MRI machine (right) during surgery. JAPAN BRANDVOICE

“If one company tried to do this alone, it would want to use its own technology and keep rivals out,” says Muragaki. “That company wouldn’t succeed in integrating all the various technologies. That’s why public institutions are vital for this kind of open innovation project. They act like the frame in a traditional sensu Japanese folding fan, keeping everything together as the project unfolds.”

The collaborations that gave birth to SCOT were recently recognized when it picked up the Minister of Health, Labour and Welfare Award as part of the first Japan Open Innovation Prize. Sponsored by the Japanese government, the accolade was set up to promote initiatives that can serve as future role models for open innovation. In Japan, companies traditionally kept R&D in-house, even in recent years. But the public and private sectors have been pushing open innovation as a vehicle for enhancing competitiveness. Collaborations between government labs, corporations and universities are now flourishing. Major telecom carrier KDDI, for instance, launched the first of a series of Open Innovation Funds in 2012, aimed at investing in IT startups in Japan and overseas.

“There’s a growing recognition that if a company categorizes itself as a camera company, for instance, it is limiting itself,” Keiichiro Koumura, an official with major real estate company Mitsui Fudosan, recently told attendees at an open innovation seminar at Mitsui Fudosan’s Base Q in Tokyo. “Because as technology changes, cameras have become smartphones. One way to address this is open innovation.”

Keiichiro Koumura of Mitsui Fudosan (center left) and Hideaki Nagano of Samurai Incubate (center right) discuss open innovation during a seminar at Base Q in Tokyo.

Keiichiro Koumura of Mitsui Fudosan (center left) and Hideaki Nagano of Samurai Incubate (center right) discuss open innovation during a seminar at Base Q in Tokyo.japan brandvoice

Looking to the future

As for SCOT, Muragaki hopes to spread the technology to other hospital facilities such as intensive care units, and apply it to other forms of surgery such as vascular operations. He also hopes to take the technology overseas.

“Most doctors are resistant to change. Before they try SCOT, surgeons don’t regard it as something that’s necessary but once they give it a go, their view changes,” says Muragaki. “After brain surgeries, we want to try the technology on bone tumors, and keep going. If you could do all surgeries with SCOT, it would decrease risks and increase benefits. That’s something we can work toward.”

To find out more about SCOT, visit the university’s website here.

For more on the Japanese Government’s innovations and technologies, please click here.

Japan is changing. The country is at the forefront of demographic change that is expected to affect countries around the world. Japan regards this not as an onus but as

Source: Open Innovation In Japan Breaks New Ground In The Operating Room

%d bloggers like this:
Skip to toolbar