August 19, 2017

Pharmaceutical Trends for 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.

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Genome Editing – Progressing Trend

The Rush for Genome Editing

Frank Magliochetti Report

The Rush for Genome Editing

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

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

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

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

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

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

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

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

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

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

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

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

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

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CDC Warns Against Using Nasal Spray Flu Vaccine

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

Frank Magliochetti Report

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

About Vaccinations, LAIVs, and Flu Season

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

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

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

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

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

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

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

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

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

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

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

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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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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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C -Diff Rates Highest in the Northeast  

Highest C-Diff Rates in US are in the Northeast

Frank Magliochetti Report

Clostridium difficile (C. difficile or C. diff) is a deadly superbug that causes severe illness, diarrhea and sometimes death in thousands of people in the United States each year. Now a study shows that infection rates of these antibiotic-resistant bacteria are highest in the Northeastern section of the nation.

northeast_frankmagliochettidifficileinfection causes inflammation of the colon and diarrhea severe enough to be life threatening. The Centers for Disease Control and Prevention (CDC) saysC. difficile is now the most common microbial cause of hospital-acquired infections in U.S. hospitals, and that these infections cost up to $4.8 billion annually in excess healthcare costs – and that number reflects the costs for just for acute care facilities, not for nursing homes or other healthcare institutions.

diffcaused nearly half a million infections in 2011, and 29,000 patients died within 30 days of receiving their initial diagnosis ofC. difficileinfection that year. C. difficile infections are usually a regional problem, as patients transfer from hospitals to nursing homes and back into the community, which allows the disease to spread.

 

C. Diff Rates Have Been Highest in the Northeast – for a Decade

Rates of this deadly superbug were highest in the Northeast over the last decade, according to a study published in the American Journal of Infection Control.

Researchers from the University of Texas analyzed 2.3 million cases of C. difficile infection that occurred between 2001 and 2010. They found the highest incidence of the infection in the Northeast, where about eight patients developed a C. difficileinfection for every 1,000 patients discharged from a hospital. The Midwest had the second highest C. diff infections at 6.4 infections per 1,000 discharges, followed by the South at five per 1,000 and the West at 4.8 infections per 1,000 discharges.

Deaths from C. difficile infections were highest in the Midwest at 7.3 percent and among older adults at 9 percent.

The scientists also discovered that C. difficile is a seasonal disease. Most cases occurred in the spring, infecting 6.2 people for every 1,000 discharges. Infection rates were second highest in the winter at 5.9 per 1,000, followed by summer and fall.

The rates of C. diff infections for adults and older adults followed the overall trends, with most adults developing a C. diffinfection (CDI) during spring. CDIs among children were highest in the winter.

“The peak incidence in the spring could be attributed to increased utilization of antibiotics in winter months,” explain the authors of the study. “Prior studies have found a 1 to 2 month lag time between antibiotic exposure and the development of CDI.”

Controlling the Risk of C. Difficile Infections in all 50 States

Over-prescribing and inappropriate prescribing of antibiotics raises the patient risk of CDI. About half of all patients receive an antibiotic at some time during hospitalization, according to CDC statistics, but 30 to 50 percent of antibiotics prescribed in hospitals are incorrect or unnecessary. Using proper infection control procedures and careful prescribing of antibiotics can prevent CDIs.c-difficile-frankmagliochetti

CDIs are usually associated with medical care; patients who take antibiotics and receive medical care are at the highest risk for aC. difficile infection.

Doctors often prescribe broad-spectrum antibiotics that kill a wide variety of dangerous bacteria. Unfortunately, these antibiotics can also kill off beneficial bacteria living in the human gut. These beneficial bacteria help digest food and boost the immune system to help protect the body against infection. Taking antibiotics can suppress these beneficial bacteria for several weeks or even months, which leaves the body vulnerable to pathogens – such as C. difficile – when the individual comes into contact with a contaminated surface or with another person with the disease. Unnecessary use of antibiotics and poor infection control increases the speed at which C. difficile spreads within a facility or between facilities when a patient transfers.

C. difficile infections cause immense suffering and death for thousands of Americans each year,” said Tom Frieden, M.D., M.P.H, and Director of the CDC. “These infections can be prevented by improving antibiotic prescribing and by improving infection control in the health care system. CDC hopes to ramp up prevention of this deadly infection by supporting State Antibiotic Resistance Prevention Programs in all 50 states.”

Source

https://www.ncbi.nlm.nih.gov/pubmed/25952045

http://www.cdc.gov/media/releases/2015/p0225-clostridium-difficile.html

https://www.cdc.gov/hai/organisms/cdiff/Cdiff_clinicians.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.

frankmagliochetti_ParcaeCapital

Handheld Medicine

Handheld Medicine: Doctors Connecting with Patients using Smartphones

Frank Magliochetti Report

Doctors are connecting with patients in an entirely new way – through smartphones.Mobile payments, apps, and digital advertising changed the way retailers work by providing new opportunities to attract new customers, build loyalty and improve sales. Now these same technologies that altered retail are revolutionizing the world of medicine. The use of smartphones and apps helps drive down costs, increases access to information, and fulfills the public’s desire for “anytime, anywhere” diagnosis, treatment and monitoring.

frankmagliochetti_doctormobilevideocallUntil now, the healthcare industry has underutilized smartphones, apps and even connected medical accessories. This is changing, as connectivity allows consumers to take control of their own care. The adoption of mobile health apps has doubled in only two years. The percentage of consumers with at least one medical, health or fitness app increased from 16 percent in 2013 to 32 percent in 2015, according to PWC.

Primary care practitioners and chronic disease managers are leading the way towards a new generation of telemedicine, and patients are eager to follow. Doctors in India set up patients with smart home monitoring kits that connect wireless to the company’s online platform. From there, patients can connect with a wide range of specialists, including dermatologists, cardiologists and fertility doctors who can conduct virtual examinations and prescribe medicine from remote locations.

Clinicians in the United States can now use their smartphones as digital otoscopes. A growing number of clinicians now send patients with chronic conditions home with connected pacemakers, glucose trackers, ECG monitors and other types of remote monitoring devices. Patients can turn their phones into precision digital scales for weighing out food or connect their bathroom scales to mobile app on their phones to track their weight. Symptom checkers, activity trackers, and on-demand e-visits are now available directly to consumers.

The Future of Smartphone Medicine

Moving towards mobile care will cause a dramatic shift in the needs of the healthcare community. Organizations will need assistance managing utilization, connecting healthcare providers working in remote locations, and overseeing the massive amount of data transferred and stored. There will be an increasing need to evaluate the security, privacy and risk associated with using these new tools.frankmagliochetti-report

Connected tools will create fresh links between healthcare and industries with which it rarely interacts, such as retail, hospitality and financial services. Connectivity will also generate more opportunities for healthcare providers and patients to plug in.

Healthcare providers can look forward to engaging in virtual medicine as more facilities build that technology into their long-term strategic plans. Virtual medicine allows health systems to move away from centralized brick-and-mortar locations towards decentralized partnerships and joint ventures to create “bedless” hospitals. Even with the limited smartphone medicine in use today, a growing share of clinicians can already deliver care remotely.

Patients are Eager to Participate

About 68 percent of adults in the United States have smartphones, according to Pew Research Center, which is up from just 35 percent in 2011. Tablet ownership is up to 45 percent.

aha_frankmagliochettiConsumer interest in telemedicine is growing as quickly as interest in smartphones. According to survey results provided by the American Hospital Association, 74 percent of U.S. consumers would be willing to use telehealth services and 30 percent already use computers or mobile devices to check for medical information. Seventy percent are comfortable communicating with their doctors via email, text or video rather than seeing them in person. More than three out of four patients believe that access to care is more important than human interaction with their healthcare providers.

Advanced hardware technology, the introduction of new apps and wireless links facilitates the move towards handheld medicine.

Sources:

http://www.pwc.com/us/en/health-industries/top-health-industry-issues/care-in-palm-of-hand.html

https://www.doctorkepaas.com/

http://www.medicalpracticeinsider.com/news/oto-converting-iphone-digital-otoscope

https://play.google.com/store/apps/details?id=rascsoft.precisionbalance&hl=en

http://weightgurus.com/http://www.pewinternet.org/2015/10/29/technology-device-ownership-2015/

http://www.aha.org/research/reports/tw/15jan-tw-telehealth.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.

frankmagliochetti_ParcaeCapital

Genome Editing – CRISPR

Frank Magliochetti Report:   CRISPR

CRISPR trials just may be one the most important healthcare industry breakthroughs of this generation

Frank Magliochetti

Almost every year, a new disease is introduced in the world which affects the population of our country. It would be wrong to say that people living in rural areas may be more prone to catch diseases than those who are living in the city. The fact is that no matter where you live or how Frank-Magliochetti_crisprhard you try to protect yourself from the outside world, there are some in-house diseases that may catch up to you.

Once such disease that can strike anyone at any time is cancer which arises through our genetics.   A disease that in some cases runs down from generation to generation which may strike no matter what we may do to help prevent it.  It is something we all dread.

A study conducted on genetic based cancer diseases was conducted in the US and finally was granted access for testing on humans on June 21st.   The NIH (National Institute of Health) gave the green light to start testing the CRISPR-Cas9 trial on humans so that help from T Cells could be enlisted to protect the body.

To understand the trial, first, one needs to understand what exactly CRISPR-Cas9 is. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a drug derived from Streptococcus pyogenes, which enabled the researchers to make permanent mutations. This introduces double stranded healing breaks in cells to activate the repair pathways in a human body. They adapt immunity in certain archaea and bacteria, which allow organisms to invade and eliminate genetic material.

This disease was discovered in 1989 but until 2007 its symptoms were unknown. 2016 has brought new hope for people to live a healthy life. The trial will be funded by Sean Parker, a tech entrepreneur who has a $250 million dollar cancer treatment center; The Parker Institute for Cancer Immunotherapy.

There have been other trials conducted but the problem with them was that the T Cells, which were reintroduced to a person’s body were not that effective, however, they did kill the NY-ESO-1, the T Cells stopped proliferating and became less effective. crispr-magliochetti

There are many hospitals all over the world that are holding CRISPR trails. Some trials were started at the beginning of August while others are set to start in September.

Hospitals such as Massachusetts General Hospital located in Boston have been conducting tests on genome editing since 2013. This is one of the oldest hospitals in Boston and gets close to 100,000 patient visits per year. There are even chances that MGH affiliated laboratories will also conduct genome editing trials.

Many more hospitals based in Boston have announced that with proper funding, they will start genome editing trials in 2017. Since the trials are so expensive, scientists will pick patients who are immune to Cas9 enzyme.

The discovery and trials of CRISPR is one of the best advancements in medical history. Though the patients for the trial will be chosen in small numbers, people living in fear that their life may end after four or five years due to a genetic illness like Leukemia may now have new hope of living a healthy and happy life.

The content below was aggregated from a Boston Globe opinion piece by Jim Kozubek please click the link to head to the official site to read the rest of the post.

https://www.bostonglobe.com/ideas/2016/09/03/crispr-and-capitalists/uX8NuPsva5L2iNI2DCBArJ/story.html

CRISPR and the capitalists

CRISPER-CAS9 IS A method of manipulating DNA that is transforming medicine and science. It is both popular (“molecule of the year!”) and dangerous (researchers have received threats from GMO activists). It is also wildly lucrative.

The first clinical trial of these tiny molecular scissors may begin by the end of the year. Meanwhile, two camps, the Broad Institute — where I held affiliation for nearly three years — and University of California at Berkeley and researcher Emmanuelle Charpentier, are locked in a patent showdown that will play out in early 2017 with perhaps a billion dollars at stake.
Society treats science as a public trust by funding it through taxes, but perhaps it shouldn’t do so indefinitely. One of the subliminal things that the CRISPR-Cas9 legal showdown tells us is that academic-industry partnerships may one day be mature enough that science may begin to forgo its tax base.

In 1943, President Franklin D. Roosevelt directed his wartime chief of research, Vannevar Bush, to find a way to extend funding after the war. In a document with soaring language entitled “Science the Endless Frontier,” Bush laid out the argument for robust federal funding engines through the National Institutes of Health, the creation of the National Science Foundation, and what would become a briskly expanding network of research scientists throughout the United States.
Read More – CLICK HERE

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