Bedside vs Telemedicine Assessments

Telemedicine for Assessing Levels of Consciousness in Comatose Patients: How Does it Compare to Bedside Assessment?

Effective care for comatose patients in intensive care units (ICUs) depends on proper intervention based on reliable assessment. Researchers recently conducted a study at Mayo Clinic Hospital in Arizona to compare the effectiveness of using telemedicine to assess levels of consciousness in comatose patients with standard bedside assessment.

Proper intervention relies on the ability to recognize changes in a comatose patient’s clinical status quickly. This had usually meant that, in order to complete an assessment, the practitioner needed to be in the same room. Advanced medical technology is changing all that and robotic medicine now allows clinicians to assess patients from across the hospital or from across the world.frankmagliochetti_Telemedice_HealthcareTrends-Innovations

Telemedicine has been around since the 1960s, when NASA built telemedicine technology into astronauts’ suits. Prior to this technology, astronauts had to rely on crewmates for an accurate diagnosis. Monitors in the suits sent biometric information about the wearer back to earth for assessment.

Computers have revolutionized telemedicine and the internet helps doctors assess patients living in remote places. This is especially helpful for patients living in underserved areas.

Despite major advances, many still worry about the effectiveness in using this technology for the most critically ill patients. A new study published in Telemedicine and e-Health should help to dispel this fear, with researchers showing that robotic telemedicine can be used successfully to complete assessments in comatose ICU patients.

Testing the Reliability of Telemedicine in the Assessment of Levels of Consciousness

Researchers enrolled 100 patients from Mayo Clinic Hospital in Arizona into the study, which occurred over a 15-month timeframe. Mean age of patient participants was 70.8 years. On average, each examination took just over 5 minutes.

Sixteen medical doctors also participated by using two scoring systems, the Glasgow Coma Scale (GCS) and the Full Outline of UnResponsiveness (FOUR) score, to assess patients’ levels of consciousness. The researchers randomly assigned two practitioners to each patient; one doctor used real-time audio and a visual robotic telemedicine system to perform the assessment and the other clinician conducted an assessment at the patient’s bedside. Each used GCS and FOUR scales.

The researchers used paired t-test and Pearson correlation coefficient (PCC) to compare the GCS and FOUR scores between bedside and Telemedicine_FrankMAgliochetti-HealthcareReportremote physician.

Differences in GCS and FOUR scores between remote and beside assessment were small. The mean Glasgow Coma Scale score at bedside was 7.5 while the mean GCS score for the remote examination was 7.23. Scores were comparable in the FOUR total scores too, with a mean bedside score of 9.63 and a mean remote score of 9.21.

The researchers also asked the clinicians about their overall satisfaction and ease of use. Ninety-five percent of remote providers rated GCS and 89% rated FOUR score as good (4/5).

Conclusions

The study is the first to evaluate the effectiveness of telemedicine in assessing patients with depressed levels of consciousness. The results suggest that doctors can reliably assess levels of consciousness in comatose patients using existing robotic telemedicine technology. Healthcare providers could adopt telemedicine to help evaluate critically ill patients in neurologically underserved areas.

“This is good news in many ways,” states lead author of the study, Amelia Adcock, M.D, in a press release issued by Mayo Clinic. “We use telemedicine frequently when evaluating acute stroke patients. This study suggests yet another way telemedicine can enhance patient care. There is a shortage of intensive care unit providers and facilities with round-the-clock patient coverage. Telemedicine can provide a way to ameliorate this shortage and improve early evaluation of critically ill patients.”

Source

http://online.liebertpub.com/doi/10.1089/tmj.2016.0225

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.

frankmagliochetti_ParcaeCapital

Early Signs of Disease Identified with Wearable Sensors

Wearable Sensors May Help Identify Early Signs of Disease

Wearable technologies may be able to do much more than monitor a person’s blood pressure or total number of steps each day, according to a new study, which suggests wearable sensors can detect early signs of serious disease.

Wearable biosensors, otherwise known as wearables, are a low-cost technology capable of measuring physiological parameters continuously or frequently. Biosensor technology is a promising approach to monitoring physiological measurements, and these devices could potentially identify significant changes in health conditions. Capable of passive and routine recording, the technology can provide immediate real-time delivery of multiple measurements to the wearer or physician. Software simplifies the technology, so using wearable biosensors requires minimal training and attention from the wearer or the clinician.frank-magliochetti-biosensors-healthcare-report

In addition to physiological measurements, wearable devices can capture the wearer’s physical activities, such as walking, running, and biking, often in conjunction with a GPS to provide information about the location of the activity.

Wearables can Track Health and Provide Useful Health Information

The newest generation of portable biosensors can measure health-related physiology changes during various activities. The goal of the study, published in PLOS Biology in January 2017, was to investigate the use of portable biosensors in this capacity and their potential role in health management, specifically in the diagnosis and analysis of disease.

The researchers fitted participants with between one and seven commercially available activity monitors. Over the course of the study, the scientists recorded more than 250,000 daily measurements, including participants’ heart rate, skin temperature, blood oxygen, sleep and calories expended collected from up to 43 individuals. The scientists then combined biosensor information with medical measurements to develop a personalized, activity-based normalization framework, which they used to identify abnormal physiological signals and detect disease.

Several participants reported minor cold-like illnesses in the study’s first two years. At the onset of these illnesses, the sensors detected higher than normal readings for skin temperature and heart rate. Blood tests showed an increase in inflammation before symptoms occurred.

Biosensors-frankmagliochetti-reportThe devices could detect physiological differences, namely variations in heart rate patterns, between insulin-sensitive and insulin-resistant individuals. The researchers also found interesting physiological changes associated with alterations in environment. Participants’ blood oxygen levels decreased during high-altitude flight, for example, and this decrease in oxygen levels correlated with fatigue.

The wearables even detected physiological changes in one person – lead author of the study, Michael Snyder – who later turned out to have Lyme disease. The geneticist never developed the telltale bulls-eye rash that usually precedes the condition, but his smart watch and other sensors detected changes in his own oxygen levels and heart rate. Shortly afterwards, Snyder developed symptoms and received an official diagnosis of Lyme disease.

The researchers concluded by saying the portable biosensors can provide information useful for the monitoring of personal activities and physiology. These devices will likely play an important role in health management and access to care by those traditionally limited by geography or socioeconomic class.

Lead author of the study, Michael Snyder, said in a press release that today’s wearables are “the equivalent of oral thermometers but you’re measuring yourself all the time.” He added wearables might someday act as a “check engine” light that tells the wearer when it is time to see a doctor.

Source

http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2001402

http://www.biosciencetechnology.com/news/2017/01/testing-wearable-sensors-check-engine-light-health-0

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.

Spending Trends in Children’s Healthcare

Spending Trends 1996 – 2013: Health Care for Children

Spending on health care for children has risen in the past 20 years and a new article sheds light on where the money goes.

Frank Magliochetti

Personal health care spending for children skyrocketed 56 percent between 1996 and 2013, according to a new study published online by JAMA Pediatrics. Increased spending in health care for children reflects the increased spending for patients of all ages, according to the statistics presented by frankmaglochetti_healthcare-report-trendsthe Centers for Medicare & Medicaid Services (CMS). The United States spent about $3.2 trillion for health care in 2015, or $9,990 per person, up 5.8 percent from the year before.

Spending Trends for Children’s Personal Health Care in the U.S., 1996 – 2013

While health care spending on children continues to rise, there is very little data on differences in spending for specific conditions, age groups, gender, and type of care. There is also a paucity of information on how spending patterns have changed over the years. To shed light on these spending patterns, Joseph L. Dieleman, Ph.D., of the University of Washington, Seattle, and his team of researchers used 183 sources of data and 2.9 billion patient records gathered from the Institute for Health Metrics and Evaluation Disease Expenditure 2013 project database. They performed annual estimates for each year from 1996 through 2013 and used inflation-adjusted 2015 dollars to report estimates.

They found that spending for pediatric health care increased from $149.6 billion in 1996 to $233.5 billion in 2013. Spending per child rose from $1,915 in 1996 to $2,777 in 2013.

frankmagliochetti_report-trends-childrenhealthcareMost of the money went for well-newborn care in inpatient settings, attention deficit/hyperactivity disorder (ADHD) and well-dental care. Payers spent $27.9 billion for inpatient well-newborn care, which was the largest condition leading to health care spending.

ADHD and well-dental care services were the second and third largest conditions leading to health care spending in children, with $20.6 billion for ADHD care and $18.2 billion for well-dental care. At $9 billion, asthma care garnered the fourth highest level of spending.

The researchers found that, at $11,741, the greatest spending per child was for infants younger than 1 year in 2013. Spending per child increased over time, rising from $1915 in 1996 to $2777 in 2013. Ambulatory care among all types of care and inpatient well-newborn care, ADHD, and asthma showed the greatest growth.

Just over 30 percent of total children’s health care went for inpatient care, 38.6 percent went towards ambulatory care, and 7.8 percent was spent on retail pharmaceuticals in 2013. More was spent on males than on females.childrenhealthcarecosts-frank-magliochetti

The findings provide information about spending trends for child health care and serve as a guide for future spending. Payers can expect larger health care spending growth rates for inpatient well-newborn care and ADHD, for example, while health care professionals can gear up to provide an increased amount of care for these conditions.

“The next step should be analyzing the factors driving increased health care spending and determining whether changes in particular subcategories of spending have been associated with improvements in processes or outcomes. It is crucial to understand whether spending increases have been appropriate or misguided and how we might target spending increases and reductions now and in the future,” the authors conclude in a press release.

Source

http://jamanetwork.com/journals/jamapediatrics/fullarticle/2593700

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/highlights.pdf

http://media.jamanetwork.com/news-item/how-much-money-is-spent-on-kids-health-care-where-does-it-go/

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.

frankmagliochetti_ParcaeCapital

Rising Drug Costs: Trend to Watch 2017

2017 Trends: Rising Drug Costs

The cost of prescription drugs has been rising rapidly since 2010, and will likely continue to rise in 2017.

Frank Magliochetti

The largest drug maker in the United States, Pfizer Inc., raised prices on 133 of its U.S. brand name products in 2015. More than three-quarters of the increases were 10 percent or more. Daraprim, the antiparasitic commonly used to treat toxoplasmosis, went from $13.50 to $750 per pill overnight in September of 2015. The price of Epipens skyrocketed 500 percent, rising from $97 in 2007 to $600 in 2016 for a two-pack set of the emergency treatment for anaphylaxis.

The total net spending on prescription drugs has grown to $309.5 billion annually, according to IMS Health, including discounts, within the past year. This makes prescription drugs the fastest growing segment of the nation’s healthcare economy. At 12.2 percent, 2014 spending on drugs dwarfs the overall frank-magliochetti-2017-medical-trendsgrowth rate of healthcare spending and the rate of spending growth on physician and hospital care. The price of drugs, rather than utilization, is the predominant driving factor in this increased drug spending.

Spending on drugs rose 8.5 percent in 2015 but total prescriptions dispensed increased by a mere 1 percent. The pharmaceutical price inflation was 7.2 percent in 2015, according to the Bureau of Labor Statistics (BLS) Producer Price Index (PPI), significantly outpacing both general inflation and medical inflation at 0.7 percent and 2.7 percent, respectively.

2017 Trends towards Higher Prices

2017 will probably see more increases in drug prices, and the rises costs will likely have a significant effect on consumers and healthcare providers. Price hikes will likely affect employees and young retirees in 2017. The results of Segal’s 2017 Health Plan Cost Trend Survey suggest prescription drug costs will rise 11.6 percent in 2017 for active employees and retirees under the age of 65, on top of 11.3 percent in 2016.

That is a huge leap for most Americans. More than 48 percent of all people living in the U.S. reportcdc-frankmagliochettireport taking at least one prescription drug in the previous month, according to statistics provided by the Centers for Disease Control and Prevention (CDC), and more than 20 percent of Americans use three or more prescription medications. Health plan cost trends have slowed, according to the Segal survey, but they continue to outpace average wage increases and inflation by more than three time.

Patients carry an increasingly heavy financial burden when it comes to drug costs, and so do hospitals faced with difficult decisions regarding the allocation of scarce resources. Inpatient drug spending rose 23.4 percent on average, according to a report by theAmerican Hospital Association (AHA), and 38.6 percent per individual hospital admission. The report details the experience of one hospital that reported that last year’s price increases for just four common drugs were equivalent to the annual salaries of 55 full-time nurses there. Drug prices will likely continue to rise in unpredictable ways while reimbursement amounts from payors will probably increase only a small amount. Hospitals will continue the struggle of balancing resources in response to changes in the drug market.

The rise in specialty drug/biotech medications will be especially high in 2017 at 18.7 percent. While specialty drugs make up less than 1 percent of all medications, the 100 insurance providers responding to the Segal’s survey said that specialty drugs now account for 35 percent of total projected prescription drug cost increases for the next year.

Source

http://www.bloomberg.com/news/articles/2015-10-02/pfizer-raised-prices-on-133-drugs-this-year-and-it-s-not-alone

http://www.imshealth.com/en/about-us/news/ims-health-study-us-drug-spending-growth-reaches-8.5-percent-in-2015

http://www.bls.gov/ppi/ppidr201512.pdf

https://www.segalco.com/media/2716/me-trend-survey-2017.pdf

http://www.aha.org/content/16/aha-fah-rx-report.pdf

http://www.cdc.gov/nchs/fastats/drug-use-therapeutic.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  – .  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.

frankmagliochetti_ParcaeCapital

Augmented Reality in Healthcare

Augmented Reality: A Disruptive Trend that is Changing Healthcare

Google Glass and other types of augmented reality (AR) never really took hold in the consumer market but the advanced technology is now poised to be a disruptive trend that will forever change healthcare for patients and providers.frankmagliochettireport_medicalaugmentedreality
A Q4 2016 report by ABI Research suggests augmented reality will gain momentum as medical professionals seek out new tools and technologies to improve care and outcome for their patients. The research firm suggests regulatory activity will push the medical profession towards AR.

About Augmented Reality in Medicine

Augmented reality is a live view of a real-world environment supplemented with computer-generated sounds, graphics or other sensory input. Unlike virtual reality, which entirely replaces the real world with a simulated one, augmented reality replaces only certain elements.
AR can include “see what I see” applications, education and training. “See what I see” apps can transmit what EMTs see to emergency department physicians. In medical applications, augmented reality applications can simulate how it would feel to have certain medical conditions.
frankmagliochetti_augmentedrealityinmedicineAR applications (apps) can help patients check visual symptoms against a medical database or share information in real time with their doctors. Patients with hearing problems can use AR apps and their smart phones to convert auditory information, such as the screech of brakes or a loudspeaker announcement on an airplane, into text displayed on the smart phone. AR apps can highlight maps of wheelchair-friendly routes when an individual visits a city for the first time.
Augmented reality can provide medical training to a large number of students, even those living in remote or impoverished areas. Students use AR to practice surgical techniques, or even allow experienced surgeons to practice procedures on a three-dimensional AR rending of a patient before performing the procedure on the actual patient.

Augmented Reality Applications are Already in Use

Eye Decide by OrcaMD is an educational application that could potential improve patient compliance. This education tool simplifies complex eye conditions and treatments in a way that improves knowledge, understanding and retention. Users can view the eyeball from any angle, with and without skin. Eye Decide also demonstrates the effects of cataracts, age-related macular degeneration (AMD), and other eye conditions, so that patients can see what a particular disease will eventually do to their vision without proper treatment.
AccuVein displays a map of a patient’s vein to make placing needles easier and more accurate. The healthcare practitioner uses a handheld scanner that detects heat radiating from the veins, converts information gathered about that heat into a map of the veins, and then projects this map onto the patient’s skin. AccuVein enjoys a 40 percent annual growth rate. By the middle of 2015, this augmented reality app had already helped more frankmagliochetti_report-augment-reality-healthcarethan 10 million patients. Sales will likely continue at a robust pace as patients and nurses demand the technology to reduce the average number of “sticks” involved in placing an intravenous (IV) needle.
Many legally blind people still have some vision but cannot see well enough to recognize faces, drive, read, or avoid obstacles in their path. VA-ST is a visor that combines a 3D camera with a computer to enhance vision by improving contrast, and highlighting edges and features. Users can even pause or zoom video for a clearer view. This technology will become more popular as the population of the United States ages and suffers age-related vision loss.
Like other industries, medicine leverages new technology to improve efficiencies and performance. The move from a per-service reimbursement structure towards one that focuses on quality of care will spur growth of augmented reality in medical settings.

Source
https://www.abiresearch.com/market-research/product/1025909-ar-in-telemedicine-training-and-first-resp/
https://itunes.apple.com/us/app/eye-decide-education-engagement/id454280553?mt=8
https://orcahealth.com/
http://www.accuvein.com/inf/
http://www.accuvein.com/2015/06/vein-visualization-emerges-as-premier-augmented-reality-application/
http://www.va-st.com/smart-specs/

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.  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.

frankmagliochetti_ParcaeCapital

Top Prescription Drug Purchases / Trends 2016

Leading Prescription Drugs Purchases and Trends of 2016

Nearly half of all Americans take at least one prescription drug each day, according to the Centers for Disease Control and Prevention (CDC), and the cost of many of the most popular and most important medications is rising.
risingprescriptioncosts_frankmagliochettiThe Price for Prescription Drugs is Rising
Each of the past three years have seen double-digit price increases, including average rises of 12.6 percent in 2014 and over 10 percent in 2015. The average price for prescription drugs has increased an average of 10 percent in the past year. Despite pushback from insurers, scrutiny from lawmakers and outcry from consumers, many pharmaceutical companies plan to increase the price of prescription drugs.
Prescription drug spending in the United States totaled about $457 billion in 2015, according to the U.S. Department of Health and Human Services (HHS), accounting for 16.7 percent of all U.S. health care spending. In the 1990s, only about 7 percent of health care spending went towards prescription drugs.
A Wall Street Journal analysis found that prices for 30 prescription drugs increased at eight times the rate of inflation, with an average price hike of 76 percent from 2010 to 2014. Retail prices for some commonly used prescription drugs increased faster than general inflation each year from 2006 to 2013, according to AARP, which translates into an annual cost of therapy of more than $11,000 for a consumer who takes a prescription medication regularly. The total was nearly three-quarters of the average Social Security retirement benefit of $15,526, almost half the median income of a person on Medicare, and nearly one-fifth of the median U.S. household income.
Most Common Prescriptions and Average Cost by State
SearchRx compiled a list of the average costs of prescription drugs by state. At an average price of $12.82 per prescription, Mississippi tops the list as the US state with the lowest average per prescription cost. Arkansas was also low at $12.93, followed by Virginia at $13.90 and Louisiana at $13.10. Hawaii was the most expensive state to fill a prescription, at an average of $19.47, followed by North Dakota at $19.07, Alaska at $18.96 per prescription, and Delaware at $18.51.

The website also lists the most commonly prescribed medications last year:
1. Atorvastatin Calcium (generic for Lipitor) – lowers cholesterol and reduces risk of heart attack, stroke, and other complications in patients with type 2 diabetes, coronary heart disease, or other risk factors
2. Levothyroxine (generic for Synthroid) – primary use is for the treatment of hypothyroidism but it is also used to treat or prevent goiter
3. Lisinopril (generic for Prinivil) – for hypertension or congestive heart failure
4. Omeprazole (generic for Prilosec) – treats symptoms of GERD
5. Metformin (generic for Glucophage) – improves blood sugar in patients with type 2 diabetes
6. Amlodipine (generic for Norvasc) – for hypertension or anginafrank-magliochetti-report-drug-pricing
7. Simvastatin (generic for Zocor) – lowers cholesterol and triglycerides
8. Hydrocodone/Acetaminophen (generic for Lortab) – relieves moderate to moderately severe pain
9. Metoprolol ER (generic for Toprol XL) – treats angina and hypertension
10. Losartan (generic for Cozaar) – treats hypertension and reduces the risk of stroke in those with heart disease
SearchRx also ranked pharmacy chains in order of least expensive to most expensive. Walmart was the least expensive, followed by Target, “other,” Rite Aid, and CVS. Walgreens was the most expensive on the list.
If current trends continue, 2017 will see higher prescription prices, increased health premiums, and continued increases in the number of Americans who take prescription drugs every day.
Source
http://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm

https://www.washingtonpost.com/news/to-your-health/wp/2016/01/11/prescription-drug-prices-jumped-more-than-10-percent-in-2015/

http://time.com/money/4406167/prescription-drug-prices-increase-why/

https://aspe.hhs.gov/pdf-report/observations-trends-prescription-drug-spending

http://www.wsj.com/articles/for-prescription-drug-makers-price-increases-drive-revenue-1444096750

http://www.aarp.org/content/dam/aarp/ppi/2016-02/RX-Price-Watch-Trends-in-Retail-Prices-Prescription-Drugs-Widely-Used-by-Older-Americans.pdf

https://www.searchrx.com/blog/2016-prescription-prices-and-purchase-trends/

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.

frankmagliochetti_ParcaeCapital

Trends in Pharma: 2017 – Biosimilars

Pharma Trends 2017:  Biosimilars

Frank Magliochetti Report

The FDA approved 56 new drugs in 2015 and, of these, 33 were specialty drugs and 23 were traditional. One was a biosimilar. Development, approval and acceptance of biosimilars may become an important trend in 2017.
The FDA is approving more specialty drugs than ever before and specialty medicines will likely face more competition in 2017. Increased FDA approval and frankmagliochetti-report-pharma-trends-biosimilarsdiscoveries of medications to treat orphan conditions and cancer will fuel competition. Biosimilars could overcome development hurdles and increase this competition even more.
Acceptance of biosimilars has been slow in the past. One of the reasons for the reluctance is that the development of biosimilars is different from that of generic drugs. Generic drugs for small molecules have a relative simple chemical structure that makes it easy to reproduce an identical chemical. It is more difficult to make a protein or peptide identical to the original biologic agent because of differences in the sugar residues attached to the protein, for example, or differences in the protein folding that make it unpredictable. This means that, even though a biosimilar has an identical peptide chain, it may not have an identical effect. These factors complicate the process of making biosimilars and increase the risk for problems.
Physician acceptance has been slow too but, as the cost of other medications rise, biosimilars will seem more attractive.
Approval of Biosimilars in 2015 and 2016
Biosimilars, which are products the FDA will approve with evidence that the medication up for approval is highly similar to an already-approved reference product, will probably continue to gain traction in 2017. The FDA has approved four biosimilars as of October 2016.
Zarxio is similar to Neupogen, according to an article published by Managed Healthcare Executive, except the biosimilar has a 15 percent lower list price. Both drugs treat low white blood cell counts associated with cancer and its treatment. The FDA approvedZarxio, made by Sandoz, in March 2015.
Inflectra is similar to Remicade to treat Crohn’s disease and ulcerative colitis. The FDA approved Inflectra in April 2016 but, due to litigation, the launch date is uncertain.
Erelzi, also made by Sandoz, is similar to Enbrel to treat arthritis. The FDA announced approval of Erelzi in August of 2016 and the expected launch date of biosimilar-frankmagliochetti-pharma-trends-2017February 2017 may be delayed.
Amjevita, by Amgen is similar to Humira and is for the treatment multiple inflammatory diseases. Amjevita became the fourth biosimilar drug to gain approval in September 2016. Launch date is set for March 2017 but may experience delays.
There are several biosimilars awaiting approval, including:
• Filgrastim by Grastofil, Apotex
• Pegfilgrastim by Apotex
• SB2 infliximab by Merck/Samsung Bioepis
• CHS‐1701 by Coherus Biosciences
• Epoetin alfa by Retacrit, Pfizer
The need for biosimilars will grow as the need for other drugs, especially cancer drugs and orphan drugs, increases. Doctors diagnose about 1.7 million cases of cancer each year, yet the death rate has fallen 23 percent since the early 1990s, partially due to new medications and treatments. The introduction of biosimilars could reduce cancer death rates even further.
Biosimilars may become one of the strongest trends in the pharmaceutical industry in upcoming years, as biosimilars have the potential to lower the cost for safe and effective treatments for a wider number of patients. Increased development of biosimilar cancer drugs is possible as some biopharmaceuticals lose patent protection.

Source
https://www.uspharmacist.com/article/record-number-of-fda-new-drug-approvals-in-2015
http://www.zarxio.com/index.jsp
http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/five-specialty-pharmaceutical-trends-watch
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
http://www.erelzi.com/
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm
http://pi.amgen.com/united_states/AMJEVITA/AMJEVITA_mg.pdf
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.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.

frankmagliochetti_ParcaeCapital

CDC Warns Against Nasal Spray Vaccine

CDC: Don’t Not Using Nasal 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.

frankmagliochetti_ParcaeCapital

Drug Breakthrough for HSDD

Sprout Pharmaceuticals

Frank Magliochetti Report

Sex, specifically women’s sexuality, is often considered a topic that the public and the media tip toe around. For some time now, there has been demand for a addyi-frank-magliochetti-reportmedication that will serve a similar function as Viagra but for the female population that requires a libido boost. Since there are pharmaceutical drugs created that aid men having trouble with sexual activity which are widely advertised and accepted as a legitimate prescription, advocates for female sexual health have been discussing this inequality in healthcare and the possible solutions. Male sexual health medicines have been around for a significant amount of time, however, the female alternative is still in the beginning stages.

Given the current political and societal atmosphere women’s sexual health is a frequently debated topic. There have been numerous doctors frankmagliochettireport_addyand advocates for the past several years that have spoken out on behalf of the need for a drug that can aid the female population that suffers from various medical issues that make participating in sexual activity difficult or altogether impossible. With the rising demand for such a product pharmaceutical companies have been working on creating the solution. In August of 2015, the FDA finally approved a pill that was developed for such a purpose. This drug called Flibanserin is made by Sprout Pharmaceuticals and is sold under the brand name Addyi; given the pink coloration of the pills they have come to be known as the “little pink pill.”

 

Sprout Pharmaceuticals has made a great breakthrough with Addyi; not enough attention has been given to finding potential solutions for those suffering with HSDD.

Frank Magliochetti

Addyi is intended for use in premenopausal women suffering from a disorder known as Hypoactive Sexual Desire Disorder (HSDD), this disorder decreases women’s libido for no known reason and negatively impacts the lives of women suffering from HSDD. HSDD can negatively impact the affected women’s relationships and generate unneeded difficulty and stress, Addyi is intended to alleviate these issues by boosting the libido in women suffering from HSDD. Addyi, unlike the potential alternatives that are in the research stages. manages to aid women in the increasing of their libido without the use of hormones. Flibanserin is designed to balance the neurotransmitters in women’s brains in order to increase their libido. The neurotransmitters that are impacted frankmagliochettireport-addyi-sproutpharmaby this drug are dopamine, serotonin, and norepinephrine.  Addyi has been available for prescription since October of 2016. According to Sprout Pharmaceuticals it should be available through insurance companies and will cost anywhere from $30 to $75 whether the patient has insurance or does not have insurance. Addyi has shown that it has a few side effects such as sleepiness, faintness (loss of consciousness) and, low blood pressure.

The pink pill was previously submitted to the FDA sixty times for approval and the continued to require additional testing to be positive that the drug was safe, effective, and could not be misused to sexually assault someone. however, the FDA now believes that by the end of the year the pink pill will be as prominent as Viagra. The strides this development is making for women’s health are phenomenal. Addyi becoming even half as popular as Viagra will demonstrate the significant changes that have been made in the way that society views women’s sexual health and will change the entire conversation  in regards to sex. Women’s pleasure is no longer a nonexistent aspect of the equation in mainstream conversations about sexual health, this development has the potential to be as groundbreaking as when the birth control pill was first developed in the 1960s.

Related Stories:

Snapshot of Sprout Pharmaceuticals

http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=182739307

Addyi general information

http://www.addyi.com/

What is HSDD?

http://www.everydayhealth.com/sexual-health/hypoactive-sexual-desire-disorder.aspx

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.

frankmagliochetti_ParcaeCapital

Innovative Development in Medicine

Innovative Medicine:  Preventative Vaccines:  Bexsero & Trumenba

Frank Magliochetti Report

One of the biggest public health epidemics occurred back in 2014; Ebola and Meningococcal B were responsible. These two diseases took 10,000 people in Sierra Leone, Guinea and Liberia. These three countries have weak health systems, which is the reason why they were unable to treat their people.

In order to fight this disease, which made its first appearance in 1976,  WHO (World Health Organization) had been trying to find a cure for many years. On August 8, 2015, WHO declared that Ebola and Meningococcal B is a disease of international concern and thus began the search for its vaccine. By late October, 2015 WHO had finally come up with two vaccines that were guaranteed to prevent Meningococcal B. Sadly; the cure for Ebola has not yet been found however, its vaccines trials are currently being conducted in Sierra Leone.who_frankmagliochettireport

Meningococcal B is caused by bacteria called “Neisseria Meningitidis”. Neisseria Meningitidis has five serogroups: B, C, Y, W and A. The most common serogroups that affect people in the US is B, C and Y.

Meningococcal B disease is not caught through the air. In fact, it is a diseasewhich is transmitted from one person to another in close physical contact. The disease commonly spreads faster in the family due to the exchange of fluids from daily contact. The disease is found at the back of the throat and later causes sepsis. Sepsis is transferred to the blood that infects the blood stream, which causes damage to the brain and spinal column. Meningococcal B often results in liver failure, vision loss, amputation of limbs and death.

bexsero-frankmagliochettireportThe two vaccines Bexsero and Trumenba specifically treat Meningococcal B and were approved by the FDA in October 2015. The trials for Bexsero were conducted in UK, Chile, Australia and Canada amongst 2,600 young adults and adolescents. The results were that the three infectious strains that cause Meningococcal were destroyed.

Another 5,000 participants in the trials conducted in the USA experienced headache, muscle and joint pain, chills, fatigue and diarrhea after receiving the vaccine. Whereas, 15,000 participants experienced less side effects. All in all, the FDA approved the vaccines because the side effects were not viewed aslong term or fatal.

An accelerated approval was used by the FDA to make this vaccine go public claiming that Meningococcal B is a life-threatening disease. The effectiveness of Bexsero was approved two months prior to the trials being conducted.

FDA recommends that the vaccine should be given to infants, children from the ages of ten till twenty three and people who have a weak immune system. It is recommended that more than one dosage should be given to people having serogroup B Meningococcal.

Anna Jaques, a non-profit Hospital in Newburyport, Massachusetts has taken extra measures and brought more doctors and experts on anna_jaques_hospitaltheir team to prepare themselves if a patient with Ebola or Meningococcal B comes to their door.

https://www.ajh.org/

Anna Jaques is a remarkable medical facility housed with some of the top health care professionals North of Boston.

Frank Magliochetti

With 2016 being the year of medical innovations, the vaccine for Meningococcal B has come as a godsend that will save millions of lives in rural areas where this disease is commonly found. The vaccines are set to be released worldwide by the end of the year.

Other News and information on Trumenba and Bexsero

Trumenba Offical Website:

http://www.trumenba.com/

Important Safety Information

  • Trumenba should not be given to anyone with a history of a severe allergic reaction after a previous dose of Trumenba
  • Individuals with weakened immune systems may have a reduced immune response
  • The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills
  • Data is not available on the safety and effectiveness of using Trumenba and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • Tell your healthcare provider prior to the vaccination if you are pregnant, or plan to become pregnant
  • Ask your healthcare provider about the risks and benefits of Trumenba. Only a healthcare provider can decide if Trumenba is right for you or your child

 

trumenba-frankmagliochettireportIndication

  • Trumenba is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidisgroup B
  • Trumenba is approved based upon demonstrated immune response against four group B strains representative of prevalent strains in the US. The effectiveness of Trumenba against diverse group B strains has not been confirmed

Bexsero

Official Site

https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/bexsero/pi/po.html?cc=3282D9F3E686&pid=

Important Safety Information

Indication

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.Bexsero_logo_4C_temp_norDNA_bigger

  • BEXSERO is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO
  • Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
  • Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%)
  • Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains
  • Vaccination with BEXSERO may not result in protection in all vaccine recipients

AAP issues meningococcal B vaccine ( Trumenba & Bexsero)  guidelines for adolescents
Trumenba and Bexsero have both been approved for the prevention of serogroup B meningococcal disease in individuals aged 10 through 25 years by the American Academy of Pediatrics Committee on Infectious Diseases.

Please Click the link below to read the entire post:

http://www.healio.com/internal-medicine/vaccination/news/online/%7B9d42e15b-0c08-477d-8b1e-f28a59c545ea%7D/aap-issues-meningococcal-b-vaccine-guidelines-for-adolescents

Pfizer heads back to school with Trumenba vaccination campaign

Please click the link below to read the entire post:

http://www.fiercepharma.com/marketing/pfizer-menb-vaccination-campaign-for-trumenba-gears-up-for-back-to-school

Teaching kids to share is usually a parental goal, but a new ad from Pfizer may have some parents rethinking the parameters.

The first campaign for meningococcal group B vaccine Trumenba highlights the dangers of MenB, which can be spread through habits common among teens–including kissing and sharing drinks and food.

The TV ad shows a mother in the hospital with her stricken son, asking “how did we get here?” The ad then goes back through events earlier in evening showing the son sharing food and drinks with several different friends at a party and kissing a girl.

“The campaign was designed to reach parents of teens and young adults during the summer and back-to-school season, when many parents are thinking about steps they can take to help protect their child’s health, including vaccination,” she said.

Trumenba is one of two vaccinations to protect against MenB, along with GlaxoSmithKline’s Bexsero. But last year, the CDC’s Advisory Committee for Immunization Practices (ACIP) stopped short of granting the pair universal recommendation. The vaccines are recommended for young adults ages 16 to 23, with a preferred age of 16 to 18, which means that doctors decide on an individual basis whether to vaccinate their patients against MenB.

watch the ad on iSpot.tv

https://www.ispot.tv/ad/ARCj/trumenba-meningitis-b

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.

frankmagliochetti_ParcaeCapital