May 26, 2017

Prenatal Fish Oil – Lower Risk of Asthma in Children

Prenatal Fish Oil Supplementation May Lower Risk of Asthma in Children

Taking fish oil supplements during pregnancy may lower the risk of asthma in children, according to a new study published in the New England Journal of Medicine.

The study shows that supplementation with long-chain polyunsaturated fatty acids (LCPUFA) during the third trimester can reduce the risk of asthma or persistent wheeze in the babies. LCPUFA supplementation also reduces the risk of lower respiratory tract infections (LRTIs) in the offspring.

Pregnant woman

Asthma in Children is a Significant Problem

Asthma is a common problem in children born in the United States. Approximately 7.4 percent of adults and 8.6 percent of children in the nation have asthma, according to the Asthma and Allergy Foundation of America (AAFA), and the number of children with the breathing disorder has been increasing since the 1980s.

Hospitalization rates for asthma are historically higher in the Northeast. Massachusetts has the highest prevalence rate for asthma at 12 percent, according to statistics presented by the Centers for Disease Control and Prevention (CDC), with several other northeastern states following with asthma prevalence rates topping 10 percent.

Fish Oil-Derived LCPUFAs in Pregnancy and Asthma in Offspring

Reduced intake of LCPUFAs may contribute to the increased incidence of wheezing and asthma in children. The researchers in the NEJM study hoped to evaluate the effects of maternal LCPUFA supplementation on offspring.

The scientists enrolled 736 pregnant women at 24 weeks of gestation into the study then randomly assigned the subjects to control and test Asthma-prenatal-fish-oil-frank-magliochetti-report-healthcaregroups. Participants in the test group received 2.4 g of n−3 LCPUFA derived from fish oil each day, while those in the control group took a placebo containing olive oil daily.

The participants’ offspring became the Copenhagen Prospective Studies on Asthma in Childhood (COPSAC) cohort. The researchers followed this group of children for several years, with pediatricians collecting clinical data for visits at 1 week after birth, and then at 1, 3, 6 months and every 6 months until the children reached 36 months of age. The pediatricians then saw the children yearly until the participants were 5 years old.

Neither the researchers nor the participants knew which group the children belonged to for the first three years of follow-up studies. During the next two years of follow-up studies, only the scientists were unaware of the group assignments.

The researchers looked primarily for persistent wheezing and asthma, but included LRTIs, eczema, asthma exacerbations, and allergic sensitization as secondary endpoints.

Ninety-five percent of the 695 children included in the COPSAC cohort completed the 3-year, double-blind follow-up portion of the study. The researchers found that the risk of asthma or persistent wheeze in the treatment group receiving LCPUFA was 16.9 percent, while the risk was 23.7 percent in the control group. This means consuming fish oil-derived LCPUFAs can lower the risk of persistent wheeze or asthma and LRTIs in offspring by nearly 7 percentage points, or one-third. Analysis of the secondary endpoints showed that supplementation reduces the risk of LRTIs, but there was no association between supplementation and asthma exacerbations, allergic sensitization, or eczema.

These findings would be extremely helpful for expectant mothers hoping to reduce the risk of asthma and other breathing problems in their children.

Source

http://www.nejm.org/doi/full/10.1056/NEJMoa1503734

http://www.aafa.org/page/asthma-facts.aspx

https://www.ncbi.nlm.nih.gov/pubmed/12214899

https://www.cdc.gov/asthma/most_recent_data_states.htm

Frank Magliochetti is Managing Partner for Parcae Capital

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release new sites dedicated to the industry. Frank currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Shingles on the Rise

Shingles on the Rise

Shingles is increasing in the United States, according to the Centers for Disease Control and Prevention (CDC), and health experts are not quite sure why.
A recent retrospective study of 2,848,765 Medicare claims showed the incidence of shingles increased 39 percent from 1992 to 2010.
About Shingles
shingles_frankmagliochettireportNearly a third people in the U.S. will develop shingles, otherwise known as herpes zoster or simply “zoster,” during their lifetime. While most people who get shingles will develop it only once but some get the disease two or three times. The risk of shingles increases with age, especially after the age of 50. Children can get shingles, but it is uncommon.
Signs and symptoms of shingles include pain, itching, or tingling of skin just before the development of a painful rash of blister-like sores. Symptoms typically develop on one side of the body, often on the face or torso. Fever, headache, chills, and upset stomach may occur. Severe pain in the affected area, known as postherpatic neuralgia (PHN), is the most common symptom of shingles.
Shingles develops as the result of exposure to the varicella zoster virus (VZV), which is the same virus that causes varicella disease, also known as chickenpox. The virus remains dormant sensory ganglia after the individual recovers from varicella; the virus can reactivate to cause shingles years later.
Are Chickenpox Vaccinations Accelerating the Increase of Shingles?
Researchers are still working to understand why the virus reactivates. It appears that an individual’s risk for shingles increases as immunity to VZV declines, as happens with aging or with the development of immunodeficiency associated with certain illnesses or treatments.
Some research suggests that exposure to varicella disease can actually boost immunity to VZV and reduce the risk for reactivation as shingles. Other research does not show this effect and the results “reflects the uncertain influence of varicella circulation on zoster epidemiology.”
Rates of chickenpox fell dramatically in the years following the implementation of the childhood varicella vaccination program in 1996, leading some scientists to speculate that the rise in shingles in adults was the result of childhood vaccination against varicella. These researchers reasoned that adults exposed to children with the virus would build immunity against varicella, and that widespread vaccination of children would provide fewer opportunities for adult exposure.
Results from a recent CDC study seem to disprove this theory. Researchers in that study used Medicare data from 1992 to 2010 and found that shingles rates shingles_frankmagliochetti-reportwere rising even before the introduction of the varicella vaccine in 1996. Furthermore, zoster rates did not accelerate after the introduction of the program.
The researchers in the CDC study also looked for any link between state varicella vaccination coverage and zoster rates, and found that the rates of shingles did not accelerate as states increased vaccination coverage. In fact, the incidence of shingles was the same in states with high vaccination coverage as it was in states with low coverage.
Furthermore, countries without routine varicella vaccination programs are experiencing similar increases in shingles rates in adults.
Like the wild-type virus that occurs in nature, the attenuated vaccine virus can reactivate to cause shingles. Children who get the varicella vaccine appear to have a much lower risk for childhood shingles than children infected with the wild-type virus. Vaccinated children are also less likely to be infected with the wild-type virus, which is more likely to reactivate as shingles as compared to the weakened vaccine virus.
While scientists have yet to discover the reasons behind the increased incidence of shingles, it is clear that zoster vaccination can prevent many cases of shingles, both in adults and in children.

Source
http://www.cdc.gov/shingles/surveillance.html
http://annals.org/aim/article/1784289/examination-links-between-herpes-zoster-incidence-childhood-varicella-vaccination
https://www.ncbi.nlm.nih.gov/pubmed/12057605
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2866606/
http://www.cdc.gov/mmwr/preview/mmwrhtml/00039897.htm
https://www.ncbi.nlm.nih.gov/pubmed/21217180

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Smart Tech: Wearable Medical Devices

Smart Tech:  Wearable Medical Devices 2017 – 2020

Smart technologies will continue to drive the ever-growing medical wearable device market in 2017 and well into the future.
The global medical wearable devices market topped $3.2 billion in revenue in 2015, according to Mordor Intelligence, which expects the market to surpass $7.9 billion in 2020 as the industry continues to grow at a healthy CAGR of 19.8 percent during that period.
wearablemedicaldevices_frank-magliochetti-reportWearable medical devices, known simply as “wearables,” are small pieces of equipment featuring sensors that attach to the body. These sensors detect and monitor changes in specific body signatures produced by various body systems and organs. Early wearable technology allowed consumers to monitor vital signs. Today’s wearables allow users to monitor food intake, activity, and sleep levels. Tomorrow’s devices may provide continuous monitoring of glucose levels, smart clothing for infants, and smart EKG necklaces for those with heart problems.
Wearables have the potential to fill a number of applications in remote patient monitoring, sports and fitness monitoring, and home healthcare. Simplified usage of these devices, coupled with the ability to synchronize with smartphones and tables, assisted growth in this segment.
Global Wearable Devices Market- Market Dynamics

There are immense potential socio-economics of wearable medical devices for multiple sectors. Fitness devices that encourage the users to exercise can significantly reduce healthcare costs, for example.

Investors are focusing on a wide variety of projects, ranging from downloadable apps to improving the size, cost and sensitivity of sensors.wearablemedicaldevices_frankmagliochettireport

Several factors propel the growth of the global wearable market. Technological innovation is perhaps the most important factor, as these advancements lead to the introduction of new products.
Diabetes and other chronic diseases are rising at a seemingly uncontrollable rate. Wearable devices will play an increasingly important role in helping doctors and patients manage chronic diseases.

Developers make wearable devices easier to use and simplify interpretation of the data collected. Simplicity encourages use.
Market penetration of smartphones, smart watches and other wearable devices will promote the use of wearable medical technology. These devices have already penetrated the market deeply, with the worldwide smart watch shipments reaching about 25 million in 2015.

Some factors, such as reimbursement issues and high device cost, will restrain the medical wearables market somewhat but the effect should be minimal, as demand should remain high.
Several companies are already exploiting the growing interest in medical wearable technology by creating affordable products that offer high value to users and their healthcare partners.

Some of the key players already operating in the medical wearable device market include:
• Dräger
• Fitbit Inc.
• Intelesens Ltd.
• Lifewatch AG
• Omron Corporation
• Polar Electro
• Philips Electronics
• Withings SAS
These wearable manufacturers will likely improve hardware in existing products and create sturdier devices within the next few years. Hardware and device ifrankmagliochettireport_wearable-medical-devicesnnovations may include larger and easier to read displays, extended battery life, waterproof hardware, and compatibility with GPS and other sensors included in a standard smart phone. Software innovations may include advanced monitoring systems and improved patient care software, such as breathing exercises and on-demand nutrition counseling.
The wearable market is expanding because the devices are autonomous, which makes them easy to use, and non-invasive. It is also growing because of its ability to help prevent and manage chronic diseases.

Source
https://www.mordorintelligence.com/industry-reports/global-wearable-medical-device-market-industry

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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2017 Trends in Cancer Care Drugs

2017 Trends in Cancer Care Drugs

Frank Magliochetti Report

Cancer drug development will continue to be a key focus area in 2017. While the number of new cancer frank-magliochettireport_2017_cancer-stopcases in the United States each year remains constant at about 1.7 million, the American Cancer Society says that the cancer death rate has plummeted 23 percent since the early 1990s. This is largely due to improved diagnostics, early detection, and new medications and treatments.
There has been extensive development of cancer medications in the past decade, and the development of oncology drugs will continue to be a key focus area in 2017. There are several important factors affecting cancer drug development in the upcoming year, including a large number of clinical trials already underway, the possibility of shortened regulatory approval time, and increases to consumer cost.

Cancer Drug Development

Extensive development of cancer medications is already underway, and much of this development will continue into 2017. New medicines, just launched within the past five years, now treat more than 20 types of tumors, according to a new report from IMS Institute for Healthcare Informatics. In fact, there were 70 new oncology treatments for more than 20 uses launched from 2011 to 2015. Further research of these new agents will likely result in approval for subsequent indications and provide therapeutic options to more patients.2017_cancertrends_frankmagliochetti
While there is substantial opportunity in the cancer drug industry, there will also be stiff competition in 2017. More than 500 companies are actively engaged in developing oncology drugs. Collectively, these companies are pursuing nearly 600 indications, primarily for non-small cell lung cancer, breast, prostate, ovarian and colorectal cancers.
This giant and diverse group of pharma companies has created a healthy pipeline of oncology drugs in clinical development. In fact, the pipeline of cancer drugs in clinical development has grown more than 60 percent over the past ten years.
Nearly 90 percent of these drugs are targeted agents, and the trend towards targeted agents will likely continue. There are more than 120 clinical development project underway for targeted agents to treat non-small cell lung cancer and melanoma, for example, and each features different mechanisms and combinations that promise new benefits.
It is taking less time for new cancer treatments to receive regulatory approval. The median time from patent filing to approval for cancer drugs in the U.S. dropped from 10.25 years in 2013 to 9.5 years in 2015. Initiatives such as the FDA Breakthrough Therapy designation expedite development and review of drugs that treat serious or life-threatening diseases or conditions.

Patient Costs may Rise

In campaign speeches, the new President-elect of the United States has promised changes to the Affordable Care Act, and these changes may increase patient costs. Average treatment costs for a year of cancer care for patients with commercial insurance plans rose 19 percent to $58,097 in 2014.  Cost increases in 2017 may depend on where the patient receives care. Outpatient services account for more than half of the total costs, according to the IMS report, and the average combined total cost of all  drugs used by the patient accounts for 28 percent of the total cost of care.
Average costs for administering cancer drugs are usually twice as high when patients receive treatment in hospital outpatient settings than when they receive care in physician offices. Higher costs for outpatient care increases patient cost responsibility. Coupons and other forms of assistance may offset the cost to consumers.

Source

http://onlinelibrary.wiley.com/doi/10.3322/caac.21332/abstract
https://morningconsult.com/wp-content/uploads/2016/06/IMS-Institute-Global-Oncology-Report-05.31.16.pdf

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Genome Editing – Progressing Trend

The Rush for Genome Editing

Frank Magliochetti Report

The Rush for Genome Editing

Gene-editing technology has sparked a frenzy of competitors fueled to develop the first of what may be thousands of treatments for genetic disorders.

From science fiction of movies like Jurassic Park to the reality of GMO foods, the concept of customizing plants, animals and even human genomes has mesmerized our imagination and culture for decades. This obsession is not surprising considering the remarkable impact of genetic engineering on our lives, and the promise it may hold for our future.crispr-genome-editing-franlmagliochetti-report_northandoverma

Modifying the genes of an organism is no easy task. It’s not as simple as removing the parts you do not like with an eraser. It involves making changes at a molecular level that are both complex and challenging.

One concern among scientists is the modifications made in human germline cells – i.e. the sperm or the egg. These are genetic changes that would actually be passed on through generations and the fear is that there could be unexpected side effects. Couple that with the ethical concerns of people misusing this technology to intentionally modify the genome to make “designer babies” with enhanced characteristics. These are some real concerns that are causing scientists to pause and weigh the pros and cons of use of this technology.

More and more companies are racing to stay ahead of the trend and become the leaders in the field.

In Cambridge MA, Intellia Therapeutics Inc. has a 65,000 square foot build out underway, however, it is still planning to functioning while under construction.

Intellia is one of a trio of startups in the Cambridge area working locally in the biotech niche known as CRISPR-Cas9. The gene-editing technology was frank-magliochetti-report_intelliadiscovered just four years ago.

Drug development historically has been a slow process – it often takes more than a decade to bring a medicine from lab to marketplace. But that’s changing, thanks to new machines that can screen drug targets faster and an entrepreneurial environment that’s more akin to high-tech than Big Pharma.frankmagliochettireport_genome_editing

Intellia has high-profile collaboration deals with Swiss drug giant Novartis AG and Regeneron Pharmaceuticals Inc. of Tarrytown, N.Y. It raised $108 million in an initial public offering in May. Their scientists are working on gene-editing treatments for everything including the hepatitis B virus to a rare form of blindness. If all goes well, it could move its earliest drug candidates into clinical trials within 18 to 24 months.

Competitors for Intellia include Editas Medicine and Crispr Therapeutics Inc. both completed their own IPOs this year. There are more to come: all with the heightened interest of investors. These companies are in a race to develop the first treatment based on gene editing.

Genome editing is going to be a hot trend to watch in 2017 and for many years to come.

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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CDC Warns Against Using Nasal Spray Flu Vaccine

CDC Recommends Not Using Nasal Spray Flu Vaccine for 2016/2017 Season

Frank Magliochetti Report

The Centers for Disease Control and Prevention (CDC) has issued its 2016-2017 influenza vaccination recommendations, which includes the use of inactivated influenza vaccine (IIV) and the recombinant influenza vaccine (RIV). One of the most notable changes to the yearly recommendations is that the CDC is not recommending the use of nasal spray flu vaccinations using live attenuated frankmagliochetti-report_flu-shot-vaccineinfluenza vaccine (LAIV) during 2016-2017, as studies show it is not effective against preventing the flu.
The studies show LAIV had no protective benefit from children ages 2 to 17. In contrast, children who received an injection were 63 percent less likely to catch influenza than are those who received no vaccination at all.
While researchers have not yet determined the underlying cause of the loss of efficacy, but it could be due to changes in the dominant viral strains circulating in the nation during flu season. LAIV worked just as well as the shot at protecting children from H3N3 and the influenza B strain in recent flu seasons, according to a study published in the journal Pediatrics, but youngsters who received LAIV were three times more likely to suffer infection with H1N1 than were children who got the shot.
H1N1 has been the dominant strain for the past few years, according to a February 2016 CDC report, which means LAIVs can leave patients unprotected from the strains most likely to cause illness this flu season.

About Vaccinations, LAIVs, and Flu Season

Influenza vaccinations protect millions of people in the United States from developing influenza each year. Flu shots also reduce severity of influenza symptoms when it does develop, and prevents cdc-frankmagliochettireporthospitalizations relating to the flu. CDC recommends yearly flu shots for everyone 6 months and older. Antibodies typically take about two weeks to develop.
Many patients, and parents of pediatric patients, prefer LAIVs because of the perceived pain or trauma of an injection. LAIVs have been under development in the United States since the 1960s, according to the CDC, and the intranasal, trivalent, cold-adapted, live, LAIV received approval in 2003 as an option for among health patients aged 5 to 49 years. Because the nasal spray contains live, weakened influenza viruses, LAIV theoretically stimulates a stronger immune response than the shots, which contain killed viruses.
Influenza activity often begins to increase in October and peak sometime in late winter or early spring. The peak week of flu activity for the 2015-2016 season occurred on the last week of March 2016,

according to the CDC, which was one of the later season peaks on record. The CDC’s adjusted overall vaccine effectiveness (VE) against influenza A and B viruses for all ages was 47 percent, while the overall VE against A(H1N1)pdm09 was 41 percent and the overall VE against influenza B was 55 percent.

Vaccine manufacturers will provide an estimated 157 to 168 million doses of injectable influenza vaccine for the U.S. market. This is on par with last year’s vaccine distribution.

Source
https://www.cdc.gov/mmwr/volumes/65/rr/rr6505a1.htm?s_cid=rr6505a1_w

http://pediatrics.aappublications.org/content/early/2016/01/04/peds.2015-3279?sso=1&sso_redirect_count=1&nfstatus=401&nftoken=00000000-0000-0000-0000000000000000&nfstatusdescription=ERROR%3a+No+local+token

https://emergency.cdc.gov/han/han00387.asp

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5213a1.htm

http://www.cdc.gov/flu/about/season/flu-season-2015-2016.htm

https://www.cdc.gov/flu/professionals/vaccination/vaccinesupply.htm

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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