MESSAGE
| DATE | 2017-02-13 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout-NYLXS] Patent Trolls Delux
|
Note the blackmail and corruption ----
-------- Forwarded Message --------
Subject: February 13, 2017: Marathon to charge $89,000 for DMD drug
after 70-fold increase
Date: Mon, 13 Feb 2017 05:21:58 -0800
From: APhA's Pharmacy Today
Reply-To: PTdaily-at-aphanet.org
To: Ruben Safir
Pharmacy Today
View this email online.
FEBRUARY 13, 2017
Marathon
to charge $89,000 for DMD drug after 70-fold increase
Wall
Street Journal (02/10/17) Walker, Joseph
Marathon
Pharmaceuticals will charge $89,000 annually for its Duchenne
muscular dystrophy (DMD) drug in the United States. The drug,
deflazacort (Emflaza), has been available in Europe for years at
just a fraction of that cost. The corticosteroid had not been
sold in this country in part because no company thought it would
be profitable enough to warrant the effort of seeking FDA
clearance. However, U.S. patients have been importing the drug
from foreign countries... Read More
▪
Masitinib for treatment of severely symptomatic
indolent
systemic mastocytosis
▪
Flu widespread in 43 states, 5 more fatal cases
in children
▪
Doctors see gains against 'an urgent threat,' C.
difficile
▪
More than 350 organizations write Trump to
endorse current
vaccines' safety
▪
Study: Drug costs lead many people to forgo prescriptions
▪
PGx helps pharmacists match right Rx to right patient
▪
The benefits of prefilled syringes
▪ Tom
Price is sworn in as HHS secretary amid Senate disunity
▪
Surrounding states push for Missouri to create
prescription
drug monitoring program
▪
Sen. Grassley launches inquiry into orphan drug
law's effect on
prices
▪
Florida lawmakers weigh barring insurers from
removing drug
coverage while policies in effect
▪
Metformin still first-line choice in diabetes, with redefined
cutoffs for use
▪
Novel
topical treatment approved for atopic dermatitis
▪
Hospira is voluntarily recalling one lot (#591053A) of
vancomycin hydrochloride for injection
▪
A
nationwide pharmacy chain responds to the opioid epidemic
▪
Medication Safety and Quality Advocate Wins Prestigious Miller
Award
Marathon to charge $89,000
for DMD drug after 70-fold increase
Wall Street Journal (02/10/17)
Walker, Joseph
Marathon
Pharmaceuticals will
charge $89,000 annually for its Duchenne muscular dystrophy (DMD)
drug in the United States. The drug, deflazacort (Emflaza), has
been available in Europe for years at just a fraction of that
cost. The corticosteroid had not been sold in this country in
part because no company thought it would be profitable enough to
warrant the effort of seeking FDA clearance. However, U.S.
patients have been importing the drug from foreign countries
since the 1990s, after clinical studies demonstrated its
potential for reducing inflammation with fewer adverse effects
than another steroid. Advocates for people with DMD say
Marathon's price is as much as 70 times higher than what most
U.S. patients now pay to purchase deflazacort from an Internet
pharmacy in the United Kingdom. That pharmacy recently informed
customers that it would stop shipping the drug to the United
States after Marathon received FDA approval for its version. The
pharmacy said it was ending the shipments "in compliance with
U.S. FDA regulations," which prohibit drug importation except
under certain circumstances, such as when a drug is not available
in the United States. In an interview, Marathon CFO Babar Ghias
noted the company will likely receive much less in net revenue
than the list price, after providing discounts to government
insurers and financial support to patients who cannot afford the
medication. In addition, he said, more patients will have access
because their insurance companies will start covering the drug
now that it has received FDA approval.
Read More |
Return to Headlines
Masitinib for treatment of
severely symptomatic indolent systemic mastocytosis
The Lancet (02/11/2017) Vol. 389,
No. 10069, P. 612 Lortholary, Olivier; Chandesris, Marie Olivia;
Livideanu, Cristina Bulai; et al.
A
French-led investigation
evaluated masitinib as a treatment for highly symptomatic
patients with indolent system mastocytosis who did not benefit
from optimal therapy. The drug was selected because it inhibits
KIT and LYN kinases, which are implicated in the pathogenesis of
this rare, lifelong disease. The Phase III, multinational trial
randomized 71 adult patients to oral masitinib and 64 to placebo.
The primary outcome was a 75% or better improvement in at least
one baseline symptom: pruritus score, weekly incidence of
flushes, depression rating, or fatigue impact scale reading. By
24 weeks, the end of the study period, cumulative response in the
primary endpoint was calculated at 18.7% for the masitinib
patients and 7.4% for the controls. Frequent serious adverse
events-including diarrhea, rash, urticaria, and asthenia-occurred
more often in the experimental group during the treatment period
than in the placebo group. No toxicities were life-threatening,
however, and over the long term, the incidence of adverse events
was similar between the treatment and placebo groups. The low
rate of serious adverse events and high rate of response suggest
that masitinib is a safe and effective treatment option for
severely symptomatic indolent systemic mastocytosis.
Read More |
Return to Headlines
Flu
widespread in 43 states,
5 more fatal cases in children
CIDRAP (02/10/17) Schnirring,
Lisa
CDC
reported Friday a significant
increase in U.S. influenza activity in the previous week.
According to CDC's influenza map, influenza is now widespread in
43 states and Puerto Rico, and high influenza activity was
reported for 23 states and New York City. CDC said the marker
that tracks clinic visits for influenza-like illness has now been
above the national baseline for 8 consecutive weeks.
Influenza-like illness nationwide reached 4.8%, up from 3.9% the
week before. Data show that influenza A accounted for 87.7% of
the detections at clinical laboratories, while influenza B
detections at clinical labs increased to 12.3% H3N2 accounted for
97.6% of the subtyped influenza A strains. CDC recorded five more
pediatric influenza deaths, bringing the season's total to 20.
Meanwhile, hospitalizations for influenza increased to 24.3 per
100,000 population; however, the rate among older adults is much
higher, at 113.5 per 100,000 population.
Read More |
Return to Headlines
Doctors see gains against 'an
urgent threat,' C. difficile
New York Times (02/10/17) Span,
Paula
Blamed
for causing 453,000
infections and 29,300 deaths annually, Clostridium difficile
infection (C. difficile) was labeled by CDC as an "urgent threat"
in 2013. Although an update from the agency is not expected until
later this year, experts at the federal watchdog believe the
incidence rate has improved for this health care-acquired
infection that causes severe diarrhea, fever, and vomiting, among
other symptoms. Much of the reason for any decline would point to
a weakening of the potent and highly drug-resistant NAP1 strain,
which inflated the C. difficile rate starting in the 2000s. In
addition, because most cases are triggered by antibiotic
use-which strips the colon of protective microbes-antibiotic
stewardship programs in hospitals and nursing homes also may have
contributed. Going forward, potential new treatments-including
the drug bezlotoxumab (Zinplava-Merck), fecal transplants to
restore healthy bacteria to the colon, and experimental
vaccines-promise to knock the rate down even more.
Read More |
Return to Headlines
More
than 350 organizations
write Trump to endorse current vaccines' safety
Washington Post (02/08/17) Sun,
Lena H.
A group
of more than 350 medical,
advocacy, and professional organizations, including APhA, sent a
letter on February 7 to President Trump expressing its
"unequivocal support for the safety of vaccines." The letter
describes vaccines the safest and most cost-effective way of
preventing disease, disability, and death. In addition, it notes
that the United States is still experiencing outbreaks of
vaccine-preventable illnesses, such as the 2014-15 measles
outbreak that began at Disneyland and the increase in pertussis
in 2012. The organizations said they would welcome a meeting with
Trump "to share the robust, extensive, scientific evidence"
supporting vaccine safety and effectiveness. After just over a
page of text, the letter continues for 26 additional pages to
list all the national and state-based groups that signed as well
as a summary of more than 40 studies on vaccine safety.
Read More |
Return to Headlines
Study: Drug costs lead many
people to forgo prescriptions
Chain Drug Review (02/07/17)
High
drug costs kept about 45
million U.S. adults (18%) from filling a prescription last year,
the nonprofit group Prescription Justice reports. Elsewhere, the
percentage of adults not filling prescriptions due to cost in
2016 was 2% in the United Kingdom, where prescriptions are
largely covered by national health insurance; 10% in Canada; 9%
in Switzerland; 6% in Australia; 6% in New Zealand; 6% in Sweden;
4% in France; 4% in the Netherlands; and 3% in Norway. The report
noted that the percentage in the United States has actually come
down from 21%, before the Affordable Care Act went into effect in
late 2013. The analysis was based on data from the Commonwealth
Fund's 2016 International Health Policy Survey of Adults, which
polled about 2,000 U.S. adults and nearly 27,000 adults overall.
Read More |
Return to Headlines
PGx
helps pharmacists match
right Rx to right patient
Pharmacy Practice News (02/07/17)
Buckley, Bruce
Health
systems are increasingly
turning to pharmacogenomics as a way to enhance therapeutic
decision-making. At the 2016 American Heart Association's
Scientific Sessions, Larisa H. Cavallari, PharmD, FCCP, BCPS,
outlined a preliminary analysis of outcomes data from seven
health systems that have been testing for the cytochrome P450
2C19 genotype in patients undergoing percutaneous coronary
intervention and using the findings to help direct antiplatelet
therapy. Investigators found that approximately 31% of patients
had a loss-of-function variant, which limits clopidogrel
(Plavix-Bristol-Myers Squibb) activation and effectiveness. Of
those, "about 60% were placed on an alternative to clopidogrel,"
said Cavallari. James M. Hoffman, PharmD, MS, chief patient
safety officer at St. Jude Children's Research Hospital, said
pharmacogenetic information is being used to improve drug therapy
at various centers of innovation, and "pharmacists are right at
the center of that effort." All patients at St. Jude are
approached about having a panel of genes tested, said Hoffman,
and the results are uploaded into the hospital's electronic
health record. "With just a small number of genes included," he
said, "nearly 80% of the patients have had an actionable result."
Read More |
Return to Headlines
The
benefits of prefilled
syringes
Pharmacy Practice News (02/07/17)
Wild, David
In
anesthesia practice, ditching
the vial-and-syringe technique of preparing medication doses in
favor of prefilled syringes promises to save money and boost
patient safety. At Mt. Sinai in New York City, for example,
buying prefilled syringes of neostigmine and ephedrine-two of the
anesthetics that are among both the most expensive and the most
likely to not be completely used-has almost certainly reduced
waste at the facility, even if some of those savings have been
eroded by the higher cost of prefilled syringes. At Boston's
Brigham and Women's Hospital, meanwhile, prefilled syringes have
"reduced our in-house compounding workload and also reduced our
purchases from outsourced compounders, which can be expensive,"
confirms director of pharmacy, business, and finance John
Fanikos. "We've been trying to make life easier for our OR nurses
and physicians by providing them with prefilled syringes for
odansetron, metoclopramide, dexamethasone, midazolam, and
diphenhydramine, rather than have these drugs prepared from
vials." The syringes are also used in inpatient units, he notes.
Ethan Bryson, associate anesthesiology professor at Icahn School
of Medicine at Mt. Sinai, agrees that prefilled syringes are a
time-saver, citing a simulation study published online last June
in the Journal of Patient Safety. Preparation time using vials
took twice as long as with prefilled syringes, according to the
research, which also found that medication error rates as high as
75% fell to the single digits when nurses used prefilled syringes
versus vial-and-syringe methods. "Having the medication predrawn
in a prelabeled syringe goes a long way to reducing the chance
that someone will make a mistake," Bryson remarked.
Read More |
Return to Headlines
Tom Price is sworn in as HHS
secretary amid Senate disunity
New York Times (02/13/17) Pear,
Robert; Rappeport, Alan
HHS
Secretary Tom Price took
office on Friday with a promise to fix what he called a "broken
health care system" that was "harming Americans and their
families." Price was approved Friday by the Senate in a
party-line vote of 52 to 47. One of the first challenges facing
the new secretary is to stabilize insurance markets and decide
the future of financial assistance provided to insurance
companies that say they have lost large amounts of money treating
patients under the Affordable Care Act (ACA). A judge on the U.S.
Court of Federal Claims ruled on Thursday that the Obama
administration had illegally reneged on a promise to pay
subsidies to an Oregon insurer, Moda Health Plan. Many other
insurers have filed similar claims. The Obama administration's
failure to pay the claims was cited as a reason for the collapse
of many nonprofit insurance cooperatives created under the ACA.
The Trump administration has not decided whether to appeal the
decision.
Read More |
Return to Headlines
Surrounding states push for
Missouri to create prescription drug monitoring program
Joplin Globe (02/12/17) Thomas,
Crystal
Missouri's neighboring states
have become discouraged by the fact that it is the only state in
the nation that does not have a database with prescription
information accessible to prescribers and pharmacists. They say
Missouri's unwillingness to create a program may be contributing
to the opioid crises in their states. Bob Twillman, MD, who sits
on the prescription drug monitoring program (PDMP) advisory board
in Kansas, expressed skepticism that Missouri will adopt a
program this year. He said he has crossed the state line each
year for 6 years to urge Missouri to pass a bill. He said the
Kansas board a few years ago found that 60% of "doctor shoppers"
live in a county that borders Missouri or was just one county
over. "We get disappointed every year," said Denise Robertson,
Arkansas' PDMP administrator, referencing Missouri's failure to
pass a PDMP law. Jason Grellner, a past president of the Missouri
Narcotics Association, testified Thursday during a PDMP hearing
in Jefferson City that he recently attended a narcotics
enforcement conference in Washington, DC, where the need for a
drug monitoring program in Missouri came up. For years, opponents
of a PDMP in Missouri have cited privacy concerns and fears of
data breaches involving personal medical information as the
reason for blocking a program.
Read More |
Return to Headlines
Sen.
Grassley launches
inquiry into orphan drug law's effect on prices
NPR Online (02/10/17) Tribble,
Sarah Jane
Sen.
Chuck Grassley (R-IA),
chairman of the Senate Judiciary Committee, has opened an inquiry
into potential abuses of the Orphan Drug Act that may have
contributed to high prices on commonly used drugs. A recent
investigation by Kaiser Health News found that the orphan drug
program intended to help desperate patients is being manipulated
by drug manufacturers. While the companies are not breaking the
law, they are using the Orphan Drug Act to secure lucrative
incentives and gain monopoly control of rare disease markets
where drugs often command astronomical price tags. More than 70
drugs that now have orphan status were first approved by FDA for
mass market use. Others are drugs that have received multiple
exclusivity periods for two or more rare conditions. About 80
drugs fall into this latter category.
Read More |
Return to Headlines
Florida lawmakers weigh
barring insurers from removing drug coverage while policies in
effect
South Florida Sun-Sentinel
(02/07/17) Hurtibise, Ron
At a
February 7 meeting of
Florida's Senate Banking and Insurance Committee, state Sen.
Debbie Mayfield (R) proposed a bill to prohibit private health
insurers from removing prescription drugs from their approved
coverage lists during the middle of a health insurance policy
term. Insurers would be able to change their lists of covered
drugs during open enrollment periods, or during a plan term if
FDA issues a health warning about the drug. Approved 6-1 by the
Banking and Insurance Committee, the bill next heads to the
Senate's Health Policy and Rules committees. A companion version
in the House is sponsored by state Rep. Ralph Massullo (R).
Groups that have voiced their support for the bill include AARP,
Florida Pharmacy Association, American College of Physicians,
American Cancer Society, Florida Medical Association, and Florida
Dermatology Association.
Read More |
Return to Headlines
Abstract News ©
Copyright 2017
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