June 26, 2017

New Study on Personal Health Care Spending

New Study Sheds Light on Personal Health Care Spending Trends in the U.S.

The amount of dollars the Unites Spends on healthcare surpasses every other nation on the planet; all in all accounting for 17% of the economy in the U.S.

Frank Magliochetti

People spend more for health care in the United States than in any other nation on earth and, according to results of a new study published in JAMA, they spend more on diabetes and ischemic heart disease than on any other health condition.

Health care spending continues to rise in the U.S., now accounting for 17 percent of the nation’s economy. health-spending-Frank-MAgliochetti-ReportDespite this spending, there is very little information on how spending varies by condition, age and through time. Joseph L. Dieleman, PhD, from the Institute for Health Metrics and Evaluation, University of Washington and a team of researchers hoped to estimate national spending on personal health care by various factors.

U.S. Spending on Health Care Trends

The researchers included 183 sources of data in the study. Data sources included insurance claims, government budgets, household surveys, facility surveys, and official U.S. records from 1996 to 2013. The scientists grouped ICD-9 codes to form 155 conditions, such as diabetes and ischemic heart disease, for consideration in the study.

One of the more interesting findings of the study was that many of the top 20 conditions of health care spending were chronic conditions with a relatively high prevalence and health burden – many of them were also preventable. This group of conditions included diabetes, ischemic heart disease, chronic obstructive pulmonary disease (COPD), and cerebrovascular disease, all of which are attributable to modifiable risk factors.

Total costs of care

Americans spent $30.1 trillion on personal health care during the years included in the study. The researchers looked at how Americans spent that money, estimating the costs of treating 155 conditions. They found that, at an estimated $101 billion, Americans spent the most on treating diabetes. Spending for ischemic heart disease came in second at $88 billion; spending for low back and neck pain was a close third at $87 billion.

Increases in costs of care

Spending for personal health care increased for 143 of the conditions investigated over the course of the study. Spending on low back and neck pain increased $57 billion during those 18 years, and spending on diabetes US-healthcare-costs-FrankMagliochettiincreased $64 billion during that period.

Of all the conditions included in the study, 57 percent of spending went towards the top 20 conditions. Spending on emergency care and retail pharmaceuticals rose the fastest, at 6.4 percent and 5.6 percent annual growth rate, respectively. When it came to spending on diabetes, 57.6 percent went to pharmaceuticals while 23.5 percent was for ambulatory care.

The study was important in that it was the first to provide modeled estimates of U.S. personal health care spending. The results were revealing in that they showed that diabetes, ischemic heart disease, and low back and neck pain presented the highest costs to American consumers. The study was limited in that it used population-weighted data to represent total national spending, which excludes incarcerated persons and those receiving care from a Veterans Affairs (VA) facility. The University of Washington institutional review board reviewed and approved the project.

The information presented in the study may be useful to health care policy makers and health care providers working towards making health care spending more cost effective for the conditions that most commonly affect people living in the United States.

Source

http://jamanetwork.com/journals/jama/fullarticle/2594716

Frank Magliochetti is Managing Partner for Parcae Capital

  • North Andover, Massachusetts

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

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NSAIDs May Prevent Colorectal Cancer

NSAIDs May Prevent the Development of Colorectal Cancer after Polyp Removal

A recent study published in the British medical journal suggests that NSAIDs may help prevent colorectal cancer after polyp removal – This post goes into more detail on the study.

Frank Magliochetti

Taking non-steroidal anti-inflammatory drugs (NSAIDs) may prevent the recurrence of advanced neoplasia, a type of polyp that is the precursor of colorectal cancer, after the surgical removal of pre-existing polyps. Recurrence rates of benign polyps and advanced neoplasia are quite high, so clinicians are eager to find easy-to-follow treatments to reduce recurrence.frankmagliochettireport-healthcare-cancer-treatments

A team of scientists from across the United States recently collaborated with Mayo Clinic researchers to determine how well NSAIDs, aspirin and other supplements prevent the recurrence of precancerous or cancerous polyps. The results of the study, published in the British medical journal BMJ suggest NSAIDs may offer the greatest protection.

About Colorectal Cancer

Colorectal cancer is the third most common type of cancer in men and woman in the United States, according to the Centers for Disease Control and Prevention (CDC), and it is the second leading cause of cancer-related deaths among cancers affecting both men and women.

Colorectal cancer, characterized by abnormal cell growth in the colon or rectum, is one of the few preventable types of cancers. Removing precancerous polyps during colonoscopy prevents those polyps from turning cancerous but it does not prevent recurrence of advanced neoplasia, also known as advanced adenomas or adenomatous polyps. A study published in PLOS showed a recurrence rate of 50.5 percent for polyps, and a 32.9 percent recurrence rate for neoplasia.

Research Suggests Non-Aspirin NSAIDs Reduces Risk of Recurrence of Precancerous Polyps

The results of the BMJ study showed that non-aspirin NSAIDs, particularly ibuprofen, work better than aspirin or many other nutritional supplements for most patients when it came to preventing the growth of advanced neoplasia. The researchers note that, because most colorectal cancers develop from neoplasia, frank-magliochetti-report-healthcare-cancer-preventionchemoprevention with NSAIDs has a favorable risk to benefit profile when it comes to reducing recurrence in those with a history of high-risk neoplasia.

  1. Hassan Murad, M.D., preventive medicine physician and clinical epidemiologist at Mayo Clinic, is the study’s senior author. “Approximately 85 percent of all colorectal cancers are thought to result from untreated adenomatous polyps,” says Murad, M.D., in a press release published by Mayo Clinic. “If we can find a way to stop their growth, we could prevent a majority of these cases.”

“We knew that aspirin and other NSAIDs have a protective effect, and that a number of other nutritional supplements have also been studied for their effectiveness in preventing cancer,” says Dr. Murad. “What we didn’t know is how they compared to each other.”

The research team conducted a meta-analysis from data obtained from 15 randomized control trials. The scientists reviewed information from 12,234 patients who were taking various supplements and medications. The researchers looked at low- and high-dose aspirin therapy, NSAIDs, vitamin D, calcium, and folic acid, and then compared each treatment alone and in different combinations.

Analysis of the information showed that non-aspirin NSAIDs worked better than all the other therapies for preventing adenomatous polyps recurrence within three to five years after removal through colonoscopy. Because these non-aspirin NSAIDs pose other health risks, this treatment may not be appropriate for all patients.

“It is important that patients and doctors have a discussion on the various risks and benefits of any medication or other therapy,” says Murad. “While a research publication may contain promising findings, it is generalized information, and each individual is different. So their care will be individualized, as well.”

Source

http://www.bmj.com/content/355/bmj.i6188

https://www.cdc.gov/cancer/colorectal/statistics/

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0050990

Frank Magliochetti is Managing Partner for Parcae Capital

  • North Andover, Massachusetts

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

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Top Prescription Drugs Purchases and Trends of 2016

Top Prescription Drugs Purchases and Trends of 2016

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

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

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

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

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

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

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

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

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

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

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Tdap Lead to Increased Trend in HPV Vaccines

Requiring Tdap May Increase HPV Vaccination in Adolescent Girls

About 9 in 10 people will get a human papillomavirus (HPV) infection at some point in their lives, according to the Centers for Disease Control and Prevention (CDC). HPV infections are associated with health problems, including several types of cancer in men and women, which means HPV infection is an urgent health problem. A new study shows that teenage girls were more likely to start the HPV vaccine series in states where schools required the meningococcal vaccine and/or the tetanus, diphtheria, and pertussis (Tdap) booster prior to admission.
frankmagliochetti_tdap-vaccineNationwide, 63 percent of girls have received at least one dose of the vaccine, and half of all boys have started the series. Low HPV vaccination coverage is an urgent public health problem and improving HPV vaccination rates will save lives. The nation’s high Tdap vaccination rate of 86 percent shows that high HPV vaccination coverage is possible.
Most cervical cancers, anal carcinomas, and oropharyngeal cancers are the result of infection with high-risk HPV strains. While vaccines capable of preventing HPV related cancers are available, low usage limits their utility.
Previous attempts at improving HPV vaccination included state laws requiring the vaccine, but many of these laws allowed for exemptions for any reason. Because parents could opt out for nearly any reason, these state laws have been largely ineffective at increasing HPV vaccination coverage.
Improving HPV Vaccination Coverage by Vaccinating Against Other Diseases
To identify policies that could improve suboptimal HPV vaccination rates, the authors of the study sought to evaluate the relationship between adolescent vaccination and states’ school entry requirements. In the study, published in the medical journal Pediatrics, researchers compared HPV vaccination coverage in teenage girls aged 13 to 17 years across states with different vaccination requirements for school entry.
The authors gathered information from published data regarding school entry requirements from the Immunization Action Coalition (2007-2012) and vaccination rates from the National Immunization Survey-Teen (NIS-Teen, 2008-2012). They analyzed Tdap booster and meningococcal vaccination rates and evaluated the possibility of increasing HPV vaccination rates by “spillover effect,” meaning schools that require vaccinations as a condition of attendance could have higher rates of HPV vaccination.

The Results

The researchers found that requiring vaccination for admission to school did indeed improve vaccination rates for HPV. Vaccination requirements also boostedfrankmagliochettireport__hpv_vaccine coverage for Tdap and meningococcal vaccinations.
Compared with other states, those states with Tdap booster and meningococcal vaccination had a 22 and 24 percentage point increases in coverage for these vaccines, respectively. States with HPV vaccination requirements had less than 1 percentage point increase in coverage. Requiring Tdap booster and meningococcal vaccinations caused an 8 and 4 percentage point spillover increases for HPV vaccination coverage.
The study was limited in that it failed to account for confounding variables, such as religion, ethnicity, and parental education. Furthermore, the study did not account for the types of school attended, as homeschooled adolescents and teens attending private schools may not be subject to the same vaccination requirements. Despite these limitations and considering the controversy surrounding HPV legislation, utilizing the spillover effect from meningococcal and Tdap vaccination may be an effective approach to improving HPV vaccination coverage.

SOURCE:

http://www.cdc.gov/vaccinesafety/vaccines/hpv-vaccine.html

http://pediatrics.aappublications.org/content/early/2016/11/05/peds.2016-1414?sso=1&sso_redirect_count=1&nfstatus=401&nftoken=00000000-0000-0000-0000-000000000000&nfstatusdescription=ERROR%3a+No+local+token

http://www.cdc.gov/hpv/infographics/vacc-coverage.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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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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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.

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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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