November 22, 2017

Diabetes Trends: National and by State

Frank Magliochetti Report – Diabetes Trends

The rates of diabetes across the United States have nearly doubled within the past 20 years, skyrocketing from 5.5 percent in 1994 to 9.3 percent in 2014. While diabetes prevalence is increasing, there is some good news on the horizon in regards to complication rates and access to preventive care.
Of the 12 states with the highest rates of diabetes, 10 are in the south, according to the CDC’s Diabetes Report Card. At 14.7 percent, Mississippi has the highest rate of diabetes. Colorado and Utah have the lowest rates of this metabolic disorder, with diabetes affecting only 7 percent of Utah residents and 6.8 percent of those living in Colorado. frankmagliochetti_diabetestrends-reportDiabetes rates vary between 8.1 and 10.4 in the Northeast. New Hampshire has the lowest rates in the region while Pennsylvania has the highest prevalence in the Northeast.
While the prevalence of diabetes is increasing, there has been a downturn in the percentage of diabetes complications over the past two decades. Deaths from hyperglycemic crisis have declined, for example, as have lower-limb amputations and end-stage renal disease. These declines may be, at least in part, the result of improvements in the rates of hypertension, high cholesterol, and smoking. Advancements in blood glucose control, early detection and management of complications, and strides in preventive care, treatment and management of diabetes.

Preventive Care Usage Trends: Across the Nation and by State

Preventive care varies considerably between states.

The percentage of adults with diabetes who report receiving preventive care practices across the nation is as follows:
• Annual foot exam: 67.5 percentfrankmagliochettireport-diabetes
• Annual eye exam: 62.8 percent
• Checked A1c two or more times a year: 68.5 percent
• Daily self-monitoring of blood glucose: 63.6 percent
• Ever attended a diabetes self-management class: 57.4 percent
• Flu vaccine: 50.1 percent
Preventive care usage varies by state. At 85.8 percent, adults with diabetes in Maine report receiving the highest number of annual foot exams as compared with all other states, while residents of Nevada received the fewest. Adults with diabetes in New Hampshire and Vermont also received more annual food exams than the national average.
Adults with diabetes in Iowa received more eye exams than those in other states at 76.5 percent, while those in Oklahoma received the least number of eye exams. Vermont diabetics were more likely to check their A1c levels more than twice a year, affordablecareact_frankmagliochettireportwhile those in Nevada were the least to receive such preventative care. Diabetes patients in Colorado had the highest percentage of attendance rates in diabetes self-management classes, while those in New York had the lowest. People with diabetes in Minnesota had the highest flu vaccination rates, and those in Florida had the lowest.
The upturn is due, at least partially, to the Affordable Care Act because it supports diabetes prevention and control by expanding insurance coverage, access to care, and consumer protections. As the result, Medicare and other insurance providers now cover an increasing number screening tests for diabetes, pre-diabetes, and for complications associated with diabetes. Providers also offer an expanding list of preventive benefits that help support beneficiaries in self-care and in making lifestyle changes that prevent or minimize development of comorbidities and complications associated with diabetes. The expansion of coverage and preventive care will continue to affect diabetes trends across the nation and within each state.

Source:
http://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html

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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Medication Adherence in the United States  

United States:  Medication Adherence Check Up

Non-adherence includes stopping, not starting, or taking less than the prescribed amount of a medication. More than half of all adults in the United States with a chronic illness report at least one episode of non-adherence to their prescription medication, according to the first National Report Card on Adherence. This report card, developed bymedical-adherance_frankmagliochettireport the National Community Pharmacists Association (NCPA), gives Americans a weak score when it comes to takingmedications as prescribed.

The Centers for Disease Control and Prevention (CDC) says that 80 percent of all medical treatments involve medication. The CDC also estimates that 20 to 30 percent of prescriptions go unfilled.

There is some good news in medication adherence trends, however. A study published in September 2016 shows that low adherence for anti-hypertensive medications decreased among Medicare beneficiaries from 37.4 percent in 2007 to 31.7 percent in 2012.

medication-adherance-appsTechnology is helping to improve adherence rates. Smartphone apps and other technologies have created a new medication adherence market, which offers computerized solutions that remind patients to take medications and take other measures to improve adherence. The global medication adherence market is growing at a significant rate, according to a P&S Market Researchpress release, boasting a 17.5 percent CAGR during 2016-2022.

 

Reasons for Poor Adherence

There are many reasons patients do not take prescriptions as directed. Forgetfulness, concerns about side effects, poor understanding of the need to take medications, affordability, and difficulty getting to the pharmacy are common reasons for poor adherence.

Pharmacy connectedness, which is a feeling of familiarity with a pharmacy provider, is an important factor when it comes to medication adherence. Only 36 percent of those who get their prescriptions by mail report pharmacy connectedness in the report card, while 67 percent of those who visit a chain pharmacy and 89 of those who go to a neighborhood pharmacy report a personal connection with their pharmacists. Patients living in the Northeast and Midwest are slightly more likely to report pharmacy connectedness; those living in urban areas are less likely to

Affordability is another primary predictor in whether a patient will take a medication as prescribed. Whether or not insurance pays for the drug, overall health and income often factor into the affordability of a medication.

Improving Medication Adherence

Healthcare providers can help patients improve medication adherence. Pharmacists are at the front line of addressing non-adherence. Establishing pharmacy connectedness with new patients and improving person connections with existing customers can help these healthcare professionals engage with clients, provide better information about the importance of taking medications as prescribed, and encourage them to better comply with medication regimens. Because of their greater personal connection with patients, independent pharmacists may be in particularly good position to optimize adherence.

Practitioners also play a vital role in stressing medication compliance, monitoring adherence, and helping patients manage side effects and other complicating factors that might prevent patients from taking medication as prescribed. Keeping patients well informed about health conditions can also improve compliance. Both prescribers and pharmacists can help reduce non-adherence by helping economically vulnerable patients find the most affordable medications.

Information, communication, and patient support help patients become engaged and involved in their own health care; they also improve patient satisfaction and loyalty. The results of the scorecard survey suggest patient engagement can reduce the currently high levels of prescription medication in the United States, and address the associated costs and health risks of non-adherence.

Source

http://www.ncpa.co/adherence/AdherenceReportCard_Full.pdf

https://www.cdc.gov/cdcgrandrounds/pdf/gr-pharmacists-10-21-2014.pdf

https://www.ncbi.nlm.nih.gov/pubmed/27432867

http://www.prnewswire.com/news-releases/global-medication-adherence-market-expected-to-grow-with-175-cagr-during-2016-2022-ps-market-research-574469501.html

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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Nobel Peace Prize Winner for Medicine – Yoshinori Ohsumi

Dr. Yochinori Ohsumi Wins Nobel Peace Prize for Medicine 

Frank Magliochetti Report

Yoshinori Ohsumi is the sole winner of the 2016 Nobel Prize in Physiology or Medicine. Dr. Ohsumi is a cell biologist who specializes in autophagy, which is the process cells use to destroy and recycle cellular components the cells no longer use. Ohsumi has worked tireless for decades to elucidate the processes behind autophagy. Because of Ohsumi’s work in the 1990s, scientists can now explore the importance of autophagy in frankmagliochettireport_yoshinori-ohsumia number of physiological processes, such as the body’s response to infection or adaptation to starvation.

Scientists of the 1950s observed a special cellular compartment, known as an organelle, which contained enzymes that digest carbohydrates, proteins, and fats. One type of specialized compartment, or lysosome, works somewhat like a furnace to break down unwanted cellular debris.

Researchers of the 1960s found large amounts of cellular content inside lysosomes, which suggests cells have a strategy for transporting large cargo to the lysosome. Further investigation revealed a new type of structure transporting cellular cargo to the lysosome. molecular level. Nobel laureate Christian de Duve coined the term autophagy, which means “self-eating,” in 1963 to describe this transport process.nobel-prize-medal-frank-magliochetti-report

In the 1970s and 1980s, researchers worked to understand another cellular system used to degrade proteins. This other system, known as the Proteasome, degrades proteins one at a time. The mechanism did not explain how the cell disposes of larger protein complexes.

In a series of experiments in the early 1990s, Dr. Ohsumi used baker’s yeast to identify the genes responsible for autophagy. Mutations in these genes can cause disease and the very process of autophagy contributes to the development of several medical conditions, including cancer and disease of the nervous system.

The scientist then went on to shed light on the underlying mechanisms in autophagy in yeast then showed that a similar mechanism occurs in human cells. His discoveries led to a new of understanding how cells recycle their content.

A Groundbreaking Experiment

Yoshinori Ohsumi worked in a number of research areas, but decided to focus on protein degradation in an organelle that corresponds to the lysosome in human cells, known as the vacuole. Researchers like Dr. Ohsumi frequently use yeast cells in research because these cells are easy to study. Yeast cells are particularly useful for indentifying genes important in complex cellular pathways.

While yeast cells are easy to study, they do present a challenge in that the cells are small, which makes their inner structures difficult to distinguish with a microscope. Because of this, Ohsumi was uncertain whether yeast cells even participate in the autophagy process. He reasoned that, if he could disrupt the degradation process while the autophagy process was active, he would be able to see cellular content slated for degradation building up within the vacuole with his microscope.autophagy_frankmagliochettireport

Ohsumi cultured mutated yeast lacking the ability to degrade cellular waste while stimulating autophagy by starving the cells. Within hours, the vacuole filled with cellular content that had not degraded. This experiment proved that autophagy exists in cells. More importantly, the discovery gave Ohsumi a way to identify and characterize key genes involved in the autophagy process. Dr. Ohsumi published his results in 1992.

Next, Dr. Ohsumi exposed yeast cells to a chemical that randomly caused mutations in genes then induced autophagy. This allowed Ohsumi to identify the genes necessary for autophagy. In subsequent studies, he was able to characterize and research the proteins encoded by these genes. Dr. Ohsumi was able to show that a cascade of proteins and protein complexes controlled the autophagy process.

Thanks to the work of Dr. Ohsumi and other scientists, we now understand how autophagy controls important physiological functions that involve the degradation and recycling of cellular components.

Source:

https://www.ncbi.nlm.nih.gov/pubmed/1400575

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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Trends in Lyme Disease: Focus on the Northeast

Lyme Disease Trends: Northeast

cdc-frankmagliochettireportState health departments report about 30,000 cases of Lyme disease each year, according to the Centers for Disease Control and Prevention (CDC), but that number does not accurately reflect the actual number of cases diagnosed around the United States. Some studies suggest the actual number of Lyme disease could be as high as 444,000.

About Lyme Disease and its Transmission

Lyme disease is a vector-borne disease, which means a carrier moves from one host to another. This carrier, known as a vector, transmits the illness but the vector does not become infected with the disease.

The deer tick is the vector for Borrelia burgdorferi, the bacterium responsible for Lyme disease. Transmission occurs when a tick carrying the Borrelia burgdorferi bites a human to feed on the individual’s blood. The bacterium moves from the intestines of the tick through its mouthparts and into the human’s bloodstream while the tick feeds.

While a number of mammals carry Borrelia burgdorferi bacterium in their blood, the most common source of infection is the white-footed mouse.frankmagliochettireport-lyme-disease

Deer ticks are most likely to transmit the bacteria after remaining attached and feeding for two or more days. Ticks are most active from April to October in most areas but may bite year-round in milder climates.

Infection occurs quickly. Research shows traces of Borrelia burgdorferi can appear in the nervous system only 12 hours after infection. Lyme disease causes a rash, usually in a bull’s-eye pattern, and flu-like symptoms. Joint pain, headaches, and weakness in the limbs can also occur.

Doctors typically treat Lyme disease with antibiotics. Patients usually enjoy a full recovery, although some patients experience symptoms that linger for six months or longer, a condition known as Post-Treatment Lyme Disease Syndrome (PTLDS) or chronic Lyme disease. Pain medicine can help those with PTLDS overcome lingering symptoms.

frank-magliochetti-report-symptoms-of-lyme-disease

About Lyme Disease Trends

Lyme disease can affect people of any age or either gender, but it is most common in boys aged 5 to 9 years.

First discovered in Lyme, Connecticut, the disease is still most common in the Midwest and, especially, in Northeastern states. In fact, 14 states account for more than 96 percent of Lyme disease cases reported to the CDC.

The U.S. Environmental Protection Agency (EPA) developed maps that, based on the number of new cases per 100,000 people, illustrate how Lyme disease reports have changed since 1991. Trending statistics include national reports and reports from the 14 states where Lyme disease is most common.

The highest human risk for Lyme disease lies in the Northeast, Mid-Atlantic and Upper Midwest.

Nationally, there were 3.74 cases of Lyme disease per 100,000 people in 1991 and 7.95 per 100,000 in 2014. The number of cases reached their highest levels in 2013, when there were 8.59 reported cases of the disease per 100,000 people.

New Hampshire, Maine, and Vermont showed the greatest increase in reported cases of Lyme disease at 93.31, 84.13, and 83.02 cases per 100,000, respectively. Extreme year-to-year variations in reporting practices prevented the EPA from calculating trend activity in Connecticut, New York, and Rhode Island.

For more information on Lyme disease, consult with your doctor or another healthcare professional.

Source

http://www.cdc.gov/lyme/stats/humancases.html

http://www.caryinstitute.org/science-program/research-projects/lyme-disease

https://www.epa.gov/climate-indicators/climate-change-indicators-lyme-disease

https://www.epa.gov/sites/production/files/2016-08/lyme_fig-2.csv

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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Fentanyl-Related Overdoses Sweeping the Northeast

Fentanyl-related Overdoses Sweeping the Northeast

Fentanyl, which killed music legend Prince, killed more people in Virginia in 2015 than any other prescription painkiller. Legally purchased fentanyl rose only 10 percent from 2007 to 2014, yet annual death rates nearly tripled in that time, rising from 48 to 134 opiodcrisis_frankmagliochettireportdeaths each year. Fentanyl was responsible for 221 deaths in Virginia, more than any other opioid except for heroin.

The problem extends well beyond the borders of Virginia. On August 15, 2016, 26 people overdosed in less than four hours in Huntington, W. VA., a small city of just 50,000 that usually sees only two or three overdoses in a day. Pending toxicology results, officials there suspect heroin laced with fentanyl.

More than 80 percent of fentanyl seizures in 2014 occurred in 10 states, according to the National Drug Early Warning System(NDEWS), with most being in the eastern United States. These states are:

  • Ohio
  • Massachusetts
  • Pennsylvania
  • Maryland
  • New Jersey
  • Kentucky
  • Virginia
  • Florida
  • New Hampshire
  • Indiana

About Fentanyl

Fentanyl is an opioid, so it has the same physiological and psychological effects as morphine, codeine and heroin. It works by causing neurological changes that relieve pain and cause a pleasant euphoria.

It is a synthetic opioid, which means fentanyl has the same chemical structure as opium and other opiates made from the poppy plant but chemists create fentanyl in a laboratory instead of extracting it from the plant. Synthesizing opioids allows the chemists to drugs that are much stronger than are their natural counterparts.fentanyl_frankmagliochetti

Doctors prescribe fentanyl to treat chronic pain. Pharmaceutical fentanyl is available a variety of forms, such as patches, lozenges, tablets and film. Illicitly produced, non-pharmaceutical fentanyl is available in powder form, which the user can snort or inject, or in pill form.

A growing number of individuals are using fentanyl for its intense, albeit short-term high and temporary feelings of euphoria. It has become a black-market drug rivaling heroin; this is especially true now that Mexican and South American cartels started making the drug in underground labs.

People who use heroin may now unwittingly buy fentanyl or heroin mixed with fentanyl, which means they are consuming considerably stronger drugs than they realize. Even small amounts of fentanyl can be lethal, so using it as heroin or mixing it with heroin can cause a quick overdose.

Carfentanil – A New, More Potent Type of Fentanyl

Designer drugs, also known as analogs, mimic the pharmacological effects of the drug. Fentanyl has many analogs, including carfentanil (also spelled carfentanyl), one of the most potent opioids ever created. At about 100 times stronger than fentanyl and 10,000 times stronger than morphine, carfentanil is a potent elephant tranquilizer – it takes only 2 milligrams to knock out a 2,000-pound elephant – and it is now showing up in heroin.

Officials in Hamilton County, OH., issued a public health statement in July 2016 after 25 people in Akron overdosed in a 3-day period carfentanil-frankmagliochettireportand nine people in Columbus overdosed in a 9-hour window; four people died from those overdoses in Akron and two more died in Columbus. Officials have recently discovered carfentanil in local supplies of heroin there. “This discovery is ominous for those with the disease of addiction, as well as for first responders, hospital teams, law enforcement and those striving to reverse overdoses,” said Hamilton County Health Commissioner, Tim Ingram. “We issued a public health alert this morning to emergency departments and nurses, first responders and clinical staff working with substance abusers and it is crucial that we get this message out to everyone who is in contact with heroin users in our area.”

 

Source:

http://www.dailyprogress.com/townnews/pharmacology/fentanyl-is-now-state-s-deadliest-painkiller/article_5e102133-dc87-5b42-994c-59b055d0d4fe.html

https://ndews.umd.edu/sites/ndews.umd.edu/files/NDEWSSpecialReportFentanyl12072015.pdf

https://pubchem.ncbi.nlm.nih.gov/compound/carfentanil

http://www.elephantcare.org/Drugs/carfenta.htm

http://www.hamiltoncountyhealth.org/files/files/Press%20Releases/Carfentanil_7_15_2016.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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Combating Antibiotic Resistant Bacteria:

How the Fight is Progressing in 2016  

Frank Magliochetti Report

Bacteria that are resistant to common antibiotics have been around for some time. Unfortunately, they have frankmagliochetti_antibodiesbecome more widespread and more deadly than they were in times past. Following are some new major developments that may result in mankind either succumbing to antibiotic resistant bacteria or overcoming it altogether.

 

A New Danger

The civil war in Syria has nearly completely destroyed vital medical infrastructure. Thousands of doctors, nurses, medics, paramedics and other medical professionals have either been killed or have fled the country. Medical equipment is in short supply and operations are commonly conducted in caves or poorly lit basements. However, the war has brought about so many cases of antibiotic resistant bacteria that Newsweek has openly questioned whether or not the war may in fact spell the end of antibiotics altogether.

The root cause for this high level of antibiotic resistant bacteria are common the world over. Syrians, like many people around the world, used antibiotics far too freely in the past. However, the ongoing war has resulted in serious bacterial infections not seen outside of war zones. What is more, as Syrians travel in search of safety and shelter, the infections could potentially spread to others. Jordan, aware of the serious dangers that these infections may pose, has wisely implemented tight new controls on the use of Colistin to ensure that it is seldom used and thus remains effective against bacterial infections.

Another altogether different danger comes from the fact that a growing number of diseases are now becomingfrankmagliochettireport_worldhealthorganization more resistant to antibiotics than ever before. As the World Health Organization recently reported, cases of antibiotic resistant chlamydia, gonorrhea and syphilis are on the rise around the world. This has led the WHO to issue new guidelines specifying which antibiotics should and should not be used to combat these diseases. Serious fungal infections are also becoming resistant to antibiotics, a new trend that could have serious consequences for people with compromised immune systems.

New Answers

Thankfully, there are new answers on the horizon. German researchers at the University of Tubingen have recently been examining the human body to look for ways to combat infection. After analyzing bacteria found in the nose, they discovered a single gene that had the potential to help them create a completely new antibiotic. This antibiotic, currently known as lugdunin, has been tested on mice and the results show that it could effectively be used to treat both MRSA and Enterococcus infections.

Scientists at the University of Melbourne have taken a different route albeit one that is no less effective. Their new genetically engineered peptide polymers (or SNAPPs as they are more commonly known) can tear down cell walls and kill bacteria rather than simply halt the growth of infection. The SNAPPs are not toxic and pose no risk to infected people but further research is needed to determine how well the treatment works and what worldeconomicforum_frankmagliochettidangers it could pose.

It is also encouraging to see that world leaders are taking the threat seriously. On September 21, the United Nations General Assembly will host an all day, high level meeting on the topic of drug-resistant bacteria. Earlier this year, the World Economic Forum called for more research into antibiotic resistant infections while the G7 noted that tackling such infections should be a priority. The G20 recently made a united commitment to working together to reduce such infections. While only time will tell if these and other efforts will be successful, there is hope that one day antibiotic resistant bacteria will no longer result in serious infections, amputations and deaths.

Source

http://www.newsweek.com/2016/09/23/bashar-al-assads-war-syria-could-spell-end-antibiotics-498035.html

http://www.who.int/mediacentre/news/releases/2016/antibiotics-sexual-infections/en/

http://www.smithsonianmag.com/smart-news/fungal-infections-are-getting-worse-they-become-drug-resistant-180960283/?no-ist

www.bbc.com/news/health-36910766

http://news.nationalgeographic.com/2016/09/in-first–united-nations-will-consider-antibiotic-resistance/

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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Mechanical Thrombectomy

Re-Emerging Technique for Removing Blood Clots

Frank Magliochetti Report

A brain stroke occurs when certain lymph, veins or arteries form a blood clot in the brain, which if not treated on time can cause brain damage, long term disability or death. CDC says that stroke is considered as one of the top five diseases and the cause of the most deaths in America. The intensity of the stroke depends on the age but Ischemic stroke usually occurs in adults. Every year, over 795,000 Americans have strokes resulting in around 130,000 deaths.   Since 2012, the standard procedure for treating a stroke has been tPA. There were trials conducted in the same year to create a more productive technique that would allow doctors to remove the blood clot completely. The FDA finally approved frankmagliochetti-report-_stent_retrieverthe “Neurovascular Stent Retriever” technique in late 2012. However, the technique did not come into fame until the year 2016. Now, this technique is used by many hospitals in the US to treat Ischemic strokes.

The technique is a mix of the stent retriever and tPA. To better understand the retriever process, one needs to understand how exactly tPA helped with removing the blood clot.

tPA, also known as Tissue Plasminogen Activator is a protein which is administered to the brain where the blood clot is. The protein converts the Plasminogen to plasmin, which breaks down the clot. This process proved successful in only one third of the patients. In the failed cases, the blood clot did reduce but did not disappear.

In order to take this process a step further, the FDA approved the neurovascular stent retriever process which removes the blood clot directly from the site.

tPA , neurovascular stent retriever process to remove blood clots has and will continue to save many lives. This re-emergence and enhancement to existing solutions can be considered a wake up call to how  existing technology can be revitalized with new breakthroughs to deliver an even more powerful solution.

-Frank Magliochetti 

First, tPA is registered so that the clot reduces in size and detaches itself from the blood vessels. Next, a stent retriever goes into the brain to remove the blood clot. The stent retriever is either made of metal or polymer and the usage of it depends on the patient’s age and the blood clot size. This neurovascular stent retriever procedure is called “Thrombectomy”

In 2012 this procedure had been used on various patients who had speedy recoveries, experts are trying to make a more flexible and thin catheter which can easily go through the femoral artery to extract the clot.

massachusettsgeneralhospital_frankmagliochetti

Massachusetts General Hospital in Boston is a 205 years old hospital that has two departments for treating strokes. The hospital has a neurology and neurosurgeon department that deals with patients with brain diseases.

According to WHO (World Health Organization), there are around 15 million people in the world who are the victims of strokes and diabetes.

WHO has encouraged all the underdeveloped countries to adopt this neurovascular stent retriever procedure. As compared to other medical innovations of 2016, this procedure has a low cost. FDA believes that by the end of 2016, Mechanical Thrombectomy will cure around 60,000 patients who will live a healthy life.who_frankmagliochettireport

 

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FDA approves Concentric Medical’s Trevo clot retrievers

http://www.massdevice.com/fda-approves-concentric-medicals-trevo-clot-retrievers/

September2, 2016

The FDA granted expanded approval to 2 of Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities.

The indications expand previous clearances for the devices, won in 2012, which cleared the stryker-frankmagliochettiretrievers for removing blood clots and restoring blood flow in stroke patients who can’t be treated with tissue plasminogen activator or for patients who didn’t respond to t-PA therapy.

“This is the first time FDA has allowed the use of these devices alongside t-PA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of t-PA alone. Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability,” FDA Center for Devices and Radiological Health neurological and physical  medicine devices division director Carlos Peña said in a press release.

“This new and unique indication for Trevo, as initial therapy for acute ischemic stroke with large vessel occlusions, has the potential to help hundreds of thousands of stroke patients,” Dr. Amrou Sarraj, of Houston’s University of Texas Health Science Center, said in prepared remarks. “These patients now have a significantly better chance for an independent life without disability.

“So many patients with major ischemic stroke due to large vessel occlusions still go untreated today, largely ending up with a devastating long term disability,” Sarraj said. “The FDA clearance of the Trevo retriever as a front-line treatment to reduce disability reinforces the importance that all caregivers in the stroke pathway – from EMS to emergency room physicians to neurologists to interventionalists – continue to come together to deliver fast and efficient treatment of stroke.”

Trevo is a transcatheter clot removal device designed to retrieve blood clots by gripping at the clot and pulling it back through the blood vessel along with the device, according to the FDA.

Approval came based on data from a clinical trial of the device along with t-PA and medical management of blood pressure and disability symptoms which found that 29% of patients treated with the Trevo device were functionally independent at 3 months, 10% higher than those not treated with the device.

Stryker picked up Concentric Medical in 2011 for $135 million.

 

Thrombectomy System Market: Overview

http://www.openpr.com/news/356824/Forecast-On-Thrombectomy-System-Market-Global-Industry-Analysis-and-Trends-till-2025.html
With rapid technological advancement, increase in the number of aging population and increase in demand for minimally invasive surgery, the thrombectomy system global market is expected to have healthy growth rate in the forecast period (2012-2025).

Thrombectomy System Market:
Depending on geographic region, global thrombectomy system market is segmented into seven key regions: North America, South America, Eastern Europe, Western Europe, Asia Pacific, Japan, and Middle East & Africa.
North America holds the largest share of the global thrombectomy system market, due to high aging population and wide technological advancement.

Wall St. darling Penumbra launches latest thrombectomy device in the U.S.

http://www.fiercebiotech.com/medical-devices/wall-st-darling-penumbra-launches-latest-thrombectomy-device-u-s

Penumbra ($PEN), one of the top devicemaker IPOs last year, unveiled its latest thrombectomy product to the U.S. market.

Dubbed the ACE 68 Reperfusion Catheter, the vascular device uses the latest tracking technology to extract blood clots in acute ischemic stroke patients more quickly and safely, the company said. The device, which is part of the company’s Penumbra System, was penumbra-frankmagliochettireportdesigned with a new tracking platform from hub to tip, and features a unique coil winding geometry along 16 transitions to deliver an optimal tracking profile.

The announcement, along with supporting data, was made Monday at the Society of NeuroInterventional Surgery’s 13th Annual Meeting in Boston.

The Alameda, CA-based company markets medical devices that include several neurovascular access products, the ACE system, neurovascular embolization products, a neurosurgical tool as well as peripheral embolization and thrombectomy devices.

Penumbra, which raised about $125 million when it went public last September, has seen its stock price trade in a 52-week range of $35.31 to $61.87. Canaccord Genuity, which recently set a price target of $67 per share for Penumbra, has raised its rating of the company to a buy. Canaccord pegged Penumbra’s market cap at $1.83 billion with a price-to-earnings ratio of 959.19.

In May, Penumbra reported total revenue grew to $57.9 million in Q1 versus $39 million for the same period a year ago. Analysts had set a consensus estimate of $53.1 million. Revenue for neuro products grew to $41.3 million for the period, and sales of peripheral vascular products increased to $16.6 million.

Trevo Clot Retrievers Approved for Use

Direct Thrombectomy Safe, Effective in Stroke Patients

FDA Approves Trevo Device for Stroke

http://www.medscape.com/viewarticle/868389

Two devices for mechanically removing blood clots now can be used in conjunction with clot-dissolving tissue plasminogen activator (tPA) as an initial therapy for acute ischemic strokes, the US Food and Drug Administration (FDA) announced today.

The devices in question are the Trevo ProVue and Trevo XP ProVue Retrievers, both from Concentric fda-frank-magliochetti-reportMedical. The FDA first approved this clot-removal technology in 2012 to restore blood flow in patients experiencing strokes who can’t receive tissue plasminogen activator (tPA) and patients who don’t respond to the drug.

In broadening the indication, the agency said that the Trevo clot retrievers should be used within 6 hours of symptom onset and only after tPA is administered.

“This is the first time FDA has allowed the use of these devices alongside tPA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of tPA alone,” said Carlos Peña, PhD, director of the Division of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health, in a news release. “Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability.”

The Trevo clot retrievers are inserted into the occluded blood vessel via catheter. An expandable wire mesh at the distal end grips the clot, which a physician can pull back through the blood vessel along with the device for extraction through a catheter or sheath.

The FDA approved the expanded indication for the Trevo clot retrieval technology on the basis of a clinical trial comparing 96 randomly selected patients treated with the device as well as tPA and medical management of blood pressure and disability symptoms; 249 patients received only tPA and medical management. Of patients undergoing thrombectomy with a Trevo device, 29% were functionally independent 3 months after their stroke. This was the case for only 19% of those forgoing thrombectomy.

The Trevo devices come with the risk of failure to retrieve the clot, malfunctions such as breakage, and navigation problems that can lead to perforated blood vessels.

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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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.

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Prescription Drugs – The Price Game

Prescription Drugs in The US 

Frank Magliochetti Report

fda-frank-magliochetti-report

If we look back ten years ago, the price of prescription drugs were fairly low and it was easy for patients to buy their medication from the pharmacy.   2016 has not only brought new innovative medical drugs and vaccines, it has brought drug prices that are much higher than before.

We might put the blame on the companies who research and manufacturer the drugs, however, the truth is  this huge influx in pricing is simply that drug companies have the right to monopolize and set  pricing how it sees fit; many wonder if the government should get involved in the pricing of a private industry produced product.

Though the products are approved by the FDA, naturally, the company/manufacturer claims they are simply working to get back their initial investment back.  Add to that private insurers and third party pharmacies, which all benefit when from the companies producing the drugs and want the market to turn towards them. It’s a loop that goes round and round from the manufacturer to the pharmacy.

frank-magliochetti-report-drug-pricingThe influx in price does not end here. With so many rare drugs created this year to fight specific diseases, there are specific companies that are the sole manufacturer of the approved drugs. The US government allows the companies to lay claim to their drug for at least twenty years after it is released. With a price rate at 100%, many people are unable to buy these drugs and hence may have to wait years for the generics to arrive in the market. These generics are priced 45% less than the original drugs.

Many place some portion of blame on the FDA due to the lengthy process and expense it takes for a drug to be accepted by the committee and then approving a virtual monopoly for the company first to the finish line.  With years of testing and billions of dollars invested in making the drug, the company is required to make further changes if the FDA does not approve the drug.

Manufacturer’s reason that the drugs are sold at high prices because they have to recoup on the research and trail funding (among other expenses) needed to bring the product to market.

The prices for drugs to fight Hepatitis or the recent EpiPen increase are two recent examples of companies exercising their right to price the drugs however they want.frank-magliochetti-report-drug-pricing

What can be done to help curb the escalating cost of new medications entering the market?  Is it a more economical FDA approval process which will help lessen the initial trial investment or more government involvement in the research and development of these much needed drugs and their pricing matrix.

A 2016 study published in the journal of the American Medical Association cites the following five reasons for the rise in prices.

Drug manufacturers in the U.S. set their own prices, and that’s not the norm elsewhere in the world.

Go to the official post by clicking the link below:

http://time.com/money/4462919/prescription-drug-prices-too-high/

Countries with national health programs have government entities that either negotiate drug prices or decide not to cover drugs whose prices they deem excessive. No similar negotiating happens in the U.S.

When a Republican-majority Congress created the Medicare drug benefit in 2003, they barred the program that now covers 40 million Americans from negotiating drug prices. Medicaid, on the other hand, must cover all drugs approved by the Food and Drug Administration, regardless of whether a cheaper, equally or more effective drug is available. And private insurers rarely negotiate prices because the third party pharmacy benefits managers that administer prescription drugs, such as Express Scripts and CVS Health, often receive payments from drug companies to shift market share in their favor, according to the study.

We allow “government-protected monopolies” for certain drugs, preventing generics from coming to market to reduce prices.

In an effort to promote innovation, the U.S. has a patent system that allows drug manufacturers to remain the sole manufacturer of drugs they’ve patented for 20 years or more. The FDA also gives drug manufacturers exclusivity for certain products, including those that treat people with rare diseases.

But sometimes, drug companies deploy questionable strategies to maintain their monopolies, the study says. The tactics vary, but they include slightly tweaking the nontherapeutic parts of drugs, such as pill coatings, to game the patent system and paying large “pay for delay” settlements to generics manufacturers who sue them over these patents.

And this is a serious problem, the study concludes, because drug prices decline to 55% of their original brand name cost once there are two generics on the market and to 33% of original cost with five generics.

The FDA takes a long time to approve generic drugs.

Application backlogs at the FDA have led to delays of three or four years before generic manufacturers can win approval to make drugs not protected by patents, the study says.

Sometimes, state laws and other “well-intentioned” federal policies limit generics’ abilities to keep costs down.

Pharmacists in 26 states are required by law to get patient consent before switching to a generic drug, the authors wrote. This reportedly cost Medicaid $19.8 million dollars in 2006 for just one drug: a statin called simvastatin whose brand name is Zocor. Costs ran higher because pharmacists didn’t get patient consent and Medicaid had to pay for the costlier brand name drug even though a cheaper product was available.

Drug prices aren’t really justified by R&D.

Although drug manufacturers often cite research and development costs when defending high prescription prices, the connection isn’t exactly true. Most of the time, scientific research that leads to new drugs is funded by the National Institutes of Health via federal grants. If not, it’s often funded by venture capital. For example, sofosbuvir, a drug that treats hepatitis C, was acquired by Gilead after the original research occurred in academic labs.

This is an ongoing issue with little short term relief in place for patients in need of pricey medications to help them live a longer healthy life.

Related information:

Reasons for the Rise in Prices

Prescription drug prices are skyrocketing in the United States due in large part to government regulations, a new analysis finds.

These regulations allow drug manufacturers to charge monopolistic prices that aren’t opposed by competing market forces, the researchers believe.

The result? For each person in the United States, $858 was spent on prescription drugs, compared with an average of $400 per person across 19 other industrialized nations. Prescription medications now comprise an estimated 17 percent of overall health care expenses, the authors of the new report said.

Drug makers charge high prices for drugs thanks largely to “market exclusivity” regulations intended to allow them to recoup the research and development costs for new breakthrough medications

To read the entire article please click the link below to head to the official CBS site:

http://www.cbsnews.com/news/whats-behind-the-sharp-rise-in-prescription-drug-prices/

Help with the high cost of hepatitis C drugs

Information below is aggregated from a USA Today article

After legal battles and lobbying efforts, thousands of people with hepatitis C are gaining earlier access to expensive drugs that can cure this condition.

States that limited access to the medications out of concern over sky-high prices have begun to lift those restrictions – many, under the threat of legal action.   And commercial insurers such as Anthem Inc. and United HealthCare are doing the same.

Massachusetts is the latest state to decide that anyone with hepatitis C covered by its Medicaid program will qualify for the newest generation of anti-viral drugs. [https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-Press-releases-items/2016-06-30-2.html] Previously, managed care plans serving Medicaid members often limited the drugs, with a list price of up to $1,000 a pill or more, to people with advanced liver disease only.

The expansion follows a threatened lawsuit against drugmakers by Massachusett’s attorney general, which induced companies to offer the state bigger rebates on the medications, making them more affordable.

Click the link below to head to the official USA Today site to read the entire article

http://www.usatoday.com/story/news/2016/07/02/kaiser-help-with-high-cost-of-hep-c-drugs/86636294/

Hepatitis C drug costs leave many without care

Hepatitis C treatment costs tens of thousands of dollars per patient. The illness progresses slowly over decades, so most states’ Medicaid programs control costs by treating the sickest first and requiring others to wait.  The conflict over hepatitis C drugs heralds a challenge likely to persist into the future, as new drugs for other illnesses thrill doctors and patients with their effectiveness — and scare health plans with their prices.

Hepatitis C is a big concern for government, because it disproportionately affects low-income people, who are more likely to be on Medicaid, and prisoners, whose care is also the state’s responsibility. An estimated 3 million to 5 million Americans, and 67,000 to 100,000 people in Massachusetts, are infected with hepatitis C, although only half know it.

Click the link to jump to the official Boston Globe website to read the entire article:

https://www.bostonglobe.com/metro/2016/04/09/for-hepatitis-patients-cure-for-high-drug-prices/j2X4aVi7BEpU5BSL0YV0vN/story.html

Mylan CEO Bresch: ‘No one’s more frustrated than me’ about EpiPen price furor

Watch the video below

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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Innovative Developments in Medical History

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.

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