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DATE | 2017-02-13 |
FROM | Ruben Safir
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SUBJECT | Subject: [Hangout-NYLXS] Patent Trolls Delux
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From hangout-bounces-at-nylxs.com Mon Feb 13 11:40:20 2017 Return-Path: X-Original-To: archive-at-mrbrklyn.com Delivered-To: archive-at-mrbrklyn.com Received: from www.mrbrklyn.com (www.mrbrklyn.com [96.57.23.82]) by mrbrklyn.com (Postfix) with ESMTP id A729B16131C; Mon, 13 Feb 2017 11:40:18 -0500 (EST) X-Original-To: hangout-at-nylxs.com Delivered-To: hangout-at-nylxs.com Received: from [10.0.0.62] (flatbush.mrbrklyn.com [10.0.0.62]) by mrbrklyn.com (Postfix) with ESMTP id CDE14161314 for ; Mon, 13 Feb 2017 11:40:13 -0500 (EST) References: <2D.FA.33326.E64B1A85-at-mta5> To: Hangout From: Ruben Safir X-Forwarded-Message-Id: <2D.FA.33326.E64B1A85-at-mta5> Message-ID: <0090a8a3-1d5b-93e5-b530-266cf65d691b-at-mrbrklyn.com> Date: Mon, 13 Feb 2017 11:40:13 -0500 User-Agent: Mozilla/5.0 (X11; Linux x86_64; rv:45.0) Gecko/20100101 Thunderbird/45.6.0 MIME-Version: 1.0 In-Reply-To: <2D.FA.33326.E64B1A85-at-mta5> Subject: [Hangout-NYLXS] Patent Trolls Delux X-BeenThere: hangout-at-nylxs.com X-Mailman-Version: 2.1.17 Precedence: list Reply-To: NYLXS Discussions List List-Id: NYLXS Discussions List List-Unsubscribe: , List-Archive: List-Post: List-Help: List-Subscribe: , Content-Type: text/plain; charset="utf-8" Content-Transfer-Encoding: quoted-printable Errors-To: hangout-bounces-at-nylxs.com Sender: "hangout"
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-------- 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
=E2=96=AA Masitinib for treatment of severely symptomatic indolent systemic mastocytosis
=E2=96=AA Flu widespread in 43 states, 5 more fatal cases in children
=E2=96=AA Doctors see gains against 'an urgent threat,' C. difficile
=E2=96=AA More than 350 organizations write Trump to endorse current vaccines' safety
=E2=96=AA Study: Drug costs lead many people to forgo prescriptions
=E2=96=AA PGx helps pharmacists match right Rx to right patient
=E2=96=AA The benefits of prefilled syringes
=E2=96=AA = Tom Price is sworn in as HHS secretary amid Senate disunity
=E2=96=AA Surrounding states push for Missouri to create prescription drug monitoring program
=E2=96=AA Sen. Grassley launches inquiry into orphan drug law's effect on prices
=E2=96=AA Florida lawmakers weigh barring insurers from removing drug coverage while policies in effect
=E2=96=AA
Metformin still first-line choice in diabetes, with redefined cutoffs for use
=E2=96=AA Novel topical treatment approved for atopic dermatitis
=E2=96=AA
Hospira is voluntarily recalling one lot (#591053A) of vancomycin hydrochloride for injection
=E2=96=AA A nationwide pharmacy chain responds to the opioid epidemic
=E2=96=AA
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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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