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Friday, December 28, 2018

Most healthcare action expected to come from the Trump administration in 2019


The work Congress does on healthcare next year — and even the year after — will be mostly for show without a lot of concrete results, experts said.
“Probably nothing is going to happen legislatively in the next 2 years around healthcare” in terms of legislation that is actually passed by both the House and Senate and signed by the president, said Chris Sloan, a director at Avalere, a healthcare consulting firm, in a phone interview. “I think the Democrats in the House are going to use this as an opportunity to showcase their policy priorities for 2020 — things like ‘Medicare for All’ or a Medicare buy-in, taking votes on those and nailing down some specifics.”
“You will also see Democrats in the House use their oversight power over [the Department of] Health and Human Services (HHS) — to hold hearings, and give pushback around things the administration is doing around the Affordable Care Act (ACA) like the expansion of association health plans and cuts in funding for marketing and outreach in the [health insurance] exchanges,” he said.
Sloan also expects a lot of activity to occur around drug pricing. “I’m not expecting a major piece of legislation around drug pricing coming out, but it’s a huge issue with a lot of traction on the right and the left… so I’d expect in the House and the Senate [to see] hearings on drug pricing,” he said. “There’s always a chance that the Democratic House and the Republican president will come together on some piece of drug pricing — like transparency reporting — but I think it’s unlikely. So the next 2 years won’t be stagnant for healthcare; there will be a lot of policy development but no major bills.”
Julius Hobson, Jr., JD, senior policy advisor at Polsinelli, a consulting firm here, was a little more optimistic — but only a little. “The first thing on my list is prescription drug pricing,” he said in a phone interview. “If there is an opportunity for Republicans and Democrats to work out something together — provided neither side tries to overreach — that will be the one thing that has the possibility of being enacted.” Possibilities for drug pricing legislation include bills supporting reimportation, pegging U.S. drug prices to those in Europe, or giving HHS the authority to negotiate drug prices under Medicare and Medicaid.
“After that, I can’t find a health issue at the moment that I think the two sides could work on,” Hobson said. “But I think we’ll see more hearings on the oversight of the ACA, especially in the House, as administration officials get dragged in to see what they’re doing.” A House floor vote on a ‘Medicare for All’ bill is also a possibility — although it won’t pass — along with more oversight on veterans’ healthcare, he added.
One area that gets little attention is healthcare costs at the Department of Defense, which is the fastest-growing portion of the budget, said Hobson. “Having been in wars for 17 years, our healthcare costs are going through the roof.” Both President George W. Bush and President Obama pushed for having military members pay more of their costs under the Tricare health insurance program for military families, “but Congress refused to do that.”
Instead of action in Congress, most of the activity on the healthcare front will probably be within the Trump administration, he continued. “There will be more attempts to get things done — things [the administration] can do that Congress is unable to do.” Expect more efforts to come from the Office of Regulatory Reform at the Centers for Medicare & Medicaid Services, “which is consistent with an executive order from last year to come up with lists of regulations they could do away with to make the system less burdensome,” Hobson predicted.
Rodney Whitlock, vice president for health policy at ML Strategies, a consulting firm here, said in a phone interview that he expected some effort to pass a bill related to Texas vs. the United States of America — the court case questioning the constitutionality of the ACA — “and I think there’s something that looks a little more like ACA stabilization in the works… [The question is] what is the difference between the things where they’re trying to make a point versus what might be actually statutorily possible.”
Bob Laszewski, president of Health Policy and Strategy Associates, a consulting firm in Alexandria, Va., agreed with the idea that both parties will be focused on the drug pricing issue. “This seems to be about the only bipartisan interest and it will be interesting to see if there is any real agreement between them,” he said in an email. “Trump’s reference pricing proposal could be an interesting spot — will he find more Democratic allies than Republicans?”
Healthcare-related taxes imposed by the ACA but not yet implemented — including taxes on “Cadillac” health insurance plans and medical devices — are another possible area of cooperation, he said. “These have only been postponed and will have to be dealt with. There does seem to be broad agreement they should not be restarted.” And the pharmaceutical industry will be pushing back against a proposal to have it pay a larger share of drug costs in the Medicare Part D “donut hole,” he added.
Finally, “Democrats will have as their top priority rubbing salt into the Republican wounds on pre-existing conditions and the recent Texas court case,” Laszewski said. “I don’t see any opportunity for bipartisan fixes. With the Supreme Court more than a year away in terms of any final decision, this will be a very dark cloud in 2019.”

Ocular Therapeutix™ Announces Completion of Debt Refinancing


Ocular Therapeutix ™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has closed a refinancing of its existing debt by entering into a new $25.0 million term loan with MidCap Financial and Silicon Valley Bank.
The 5-year term loan facility allows for an expansion of the Company’s prior $18 million credit facility to $25.0 million, all of which was drawn at closing. The proceeds from the loan were used to repay the approximately $12.3 million remaining balance under the prior facility and provide an additional $12.0 million of new funds, net of expenses and fees. The restated and amended agreement extends the term of the credit facility until December 21, 2023 and permits the Company to make interest-only payments until January 1, 2021.
“We are pleased with the expansion and extension of our credit facility which not only strengthens our balance sheet with net new funds of $12.0 million but also improves near term cash flow through interest-only payments for the next 24 months, collectively extending the Company’s cash runway, based on current plans and forecasted expenses, into the third quarter of 2019,” said Donald Notman, Chief Financial Officer.

Alnylam to Webcast Presentation at J.P. Morgan Healthcare Conference


Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 at 10:30 am PT (1:30 pm ET) at The Westin St. Francis in San Francisco. This presentation will include an update on unaudited fourth quarter 2018 global net product revenues for ONPATTRO® (patisiran) as well as additional updates on the product’s commercial launch. In addition, the Company will webcast the Q&A breakout session immediately following its presentation at 11:00 am PT (2:00 pm ET).
A live audio webcast of both the presentation and breakout session will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after the event.

CTI BioPharma Announces Completion of Enrollment in Phase 2 Study


CTI BioPharma Corp. (NASDAQ:CTIC) announced today the completion of full enrollment of 150 patients in the PAC203 Phase 2 study of pacritinib. The Company expects to report the determination of the optimal dose of pacritinib in mid-2019 following a meeting with the U.S. Food and Drug Administration (FDA). Topline efficacy and safety data are expected in the third quarter of 2019, with the new Phase 3 study targeted to commence enrollment in the third quarter of 2019.
As previously announced, the Company has received input from the FDA on key elements of the design of a new randomized Phase 3 study of pacritinib in adult patients with myelofibrosis (primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis) and who have severe thrombocytopenia (as defined by patients with platelet counts of less than 50,000 per microliter), an indication that has been recognized by the medical community as an important unmet medical need. A planned interim safety review by an Independent Data Monitoring Committee (IDMC) is scheduled to occur in the first quarter of 2019.
The PAC203 study is evaluating the safety and efficacy of three dosing schedules (100 mg once daily, 100 mg twice daily and 200 mg twice daily) over 24 weeks in patients with myelofibrosis previously treated with ruxolitinib. More information on the PAC203 trial can be found at ClinicalTrials.gov at https://clinicaltrials.gov/ct2/show/NCT03165734.

Diseases through decades: what to look out for in your 40s, 60s, 80s and beyond


Many diseases develop and become more likely as we age. Here are some of the most common conditions, and how you can reduce your risk of getting them as you clock over into a new decade.
In your 40s
Maintaining a healthy weight can reduce the risk of developing arthritis, coronary heart , and other common and related conditions, including back pain, type 2 diabetes, stroke, and many cancers. But almost one-third of Australians in their 40s are obese and one in five already have arthritis.
From the age of 45 (or 35 for Aboriginal and Torres Strait Islanders), heart health checks are recommended to assess  and initiate a plan to improve the health of your heart. This may include changing your diet, reducing your alcohol intake, increasing your physical activity, and improving your well-being.
Checks to identify your risk of type 2 diabetes are also recommended every three years from age 40 (or from age 18 for Aboriginal and Torres Strait Islanders).
If you don’t already have symptoms of arthritis or if they’re mild, this decade is your chance to reduce your risk of the disease progressing. Focus on the manageable factors, like shedding excess weight, but also on improving muscle strength. This may also help to prevent or delay sarcopenia, which is the decline of skeletal muscle tissue with ageing, and back pain.
Most people will begin to experience age-related vision decline in their 40s, with difficulty seeing up close and trouble adjusting to lighting and glare. A baseline eye check is recommended at age 40.
In your 50s
In your 50s, major eye diseases become more common. Among Australians aged 55 and above, , cataracts, diabetes-related eye diseases and glaucoma account for more than 80% of vision loss.
A series of health screenings are recommended when people turn 50. These  can help with the early detection of serious conditions and optimising your treatment choices and prognosis. Comprehensive eye assessments are recommended every one to two years to ensure warning signs are detected and vision can be saved.
National cancer screening programs for Australians aged 50 to 74, are available every two years for bowel and breastcancer.
To screen for bowel cancer, older Australians are sent a test in the post they can do at home. If the test is positive, the person is then usually sent for a colonoscopy, a procedure in which a camera and light look for abnormalities of the bowel.
In 2016, 8% of people screened had a positive test result. Of those who underwent a colonoscopy, 1 in 26 were diagnosed with confirmed or suspected bowel cancer and one in nine were diagnosed with adenomas. These are potential precursors to bowel cancer which can be removed to reduce your future risk.
To check for , women are encouraged to participate in the national mammogram screening program. More than half (59%) of all breast cancers detected through the program are small (less than or equal to 15mm) and are easier to treat (and have better survival rates) than more advanced cancers.
In your 60s
Coronary heart disease,  (a disease of the lungs that makes breathing difficult), and lung cancer carry the biggest disease burden for people in their 60s.
If you’re a smoker, quitting is the best way to improve both your lung and heart health. Using evidence-based methods to quit with advice from a health professional or support service will greatly improve your chances of success.
The build-up of plaques in artery walls by fats, cholesterol and other substances (atherosclerosis) can happen from a younger age. But the hardening of these plaques and narrowing of arteries, which greatly increases the risk of heart disease and stroke, is most likely to occur from age 65 and above.
Exercise protects against atherosclerosis and research consistently shows any physical activity is better than nothing when it comes to heart health. If you’re not currently active, gradually build up to the recommended 30 minutes of moderate-intensity exercise on most, preferably all, days.
Other potentially modifiable risk factors for stroke include , a high-fat diet, alcohol consumption, and smoking.
Your 60s is also a common decade for surgeries, including joint replacements and cataract surgery. Joint replacements are typically very successful, but are not an appropriate solution for everyone and are not without risks. After a , you’ll benefit from physiotherapy, exercise, and maintaining a healthy weight.
The treatment for cataracts is to surgically remove the cloudy lens. Cataract surgery is the most common elective surgery worldwide, with very low complication rates, and provides immediate restoration of lost vision.
In your 70s
Many of the conditions mentioned above are still common in this decade. It’s also a good time to consider your risk of falls. Four in ten people in their 70s will have a fall and it can lead to a cascade of fractures, hospitalisations, disability and injury.
Osteoporosis is one cause of falls. It occurs most commonly in post-menopausal women but almost one-quarter of people with osteoporosis are men. Osteoporosis is often known as a silent disease because there are usually no symptoms until a fracture occurs. Exercise and diet, including calcium and vitamin D, are important for bone health.
Older people are also vulnerable to mental health conditions because of a combination of reduced cognitive function, limitations in physical health, social isolation, loneliness, reduced independence, frailty, reduced mobility, disability, and living conditions.
In your 80s and beyond
Dementia is the second most common chronic condition for Australians in their 80s, after  – and it’s the most common for people aged 95 and above.
Many people think dementia is a normal part of the ageing process, but around one-third of cases of dementia could be prevented by reducing  factors such as high blood pressure and obesity at mid-life.
Early diagnosis is important to effectively plan and initiate appropriate treatment options which help people live well with dementia. But dementia remains underdiagnosed.
Around 70% of Australians aged 85 and above have five or more chronic diseases and take multiple medications to manage these conditions. Effective medication management is critical for people living with multiple  because medications for one condition may exacerbate the symptoms of a different coexisting condition.

Earlier interventions needed to prevent inactivity in children


Physical activity is presumed to decline with the start of adolescence, however, new research shows that this decline begins earlier than previously thought.
Physical  and sedentary  were studied over a five-year period in 600 children from the Childhood Obesity Project (CHOP). Measurements were taken at the ages of 6, 8 and 11 years. The results showed that the decline of physical activity and the increase of sedentary behaviour started well before adolescence. Interventions to prevent inactivity are needed much earlier, in young children, whilst  are still high.
Increases in sedentary behaviour and lack of physical activity are connected to a number of non-communicable diseases worldwide, including type 2 diabetes. Physical activity is thought to be a major influencing factor in the prevention and management of overweight and obesity in childhood and adolescence. In addition, low levels of activity during childhood can be the cause of increasing inactivity in adults.
Researchers from Ludwig-Maximilians-University of Munich, and part of the DynaHEALTH project, studied both light physical activity (LPA) and moderate or vigorous physical activity (MVPA), as well as looking separately at sedentary behaviour (periods of sitting). Most other studies are focused on total physical activity and MPVA but exclude LPA and sedentary behaviour. However, the analysis of sedentary behaviour has become more important because of the huge increase in sitting activities in children over recent years.
The aim of this study was to analyse the change of total physical activity, MVPA, LPA and sedentary behaviour, from 6 to 11 years and to identify the factors that influence this development with age. Results showed that total physical activity and LPA gradually declined, whereas MVPA remained relatively stable between 6 and 8 years but revealed a steep drop-off by 11 years of age. They also showed that there was a steep decline, between 8 and 11 years, in the number of children fulfilling current physical activity guidelines, of 60 minutes per day in MVPA. There were also differences between boys and girls; girls seem to be more active in light-intensity activities and boys more in high-intensity activities.
Lead author of the paper, Phillipp Schwarzfischer said “Our study emphasises that a  and detailed analysis of intensity levels at an early age can give deeper insights into the development of physical activity. This is vital for effective public health planning and future intervention programmes should look to start earlier than at school age, to convey the importance of  when levels are still high.”
The article in Pediatrics (2018) is “Physical Activity and Sedentary Behavior From 6 to 11 Years,” by Phillipp Schwarzfischer et al.
More information: Phillipp Schwarzfischer et al. Physical Activity and Sedentary Behavior From 6 to 11 Years, Pediatrics(2018). DOI: 10.1542/peds.2018-0994

How parents can help their young children develop healthy social skills


As the new year dawns, parents likely turn their thoughts to their child and new beginnings they may experience as they enter an early childhood education and care centre or preschool. Naturally, it’s a time of reflection on the previous year, and excitement about the possibilities for the new year to come.
Parents might reflect on friendships their child makes in the coming year. Making friends is not always instinctive for a young child. Learning to make friends is part of the social development curriculum in early childhood.
Social  skills are just as important as  when learning. In recent studies, positive social skills are highlighted as key predictors for better outcomes in adulthood. It’s important for parents to be aware of ways to ensure positive social development skills in their young child.
Parents can begin by looking for interpersonal people skills, such as empathy, listening and communication skills. This will help your child transition into the next stage of their educational journey.
Is your child’s social development on track, at risk or vulnerable?
The Australian Early Development Census (AEDC) researches longitudinal data about the five important learning domains for a young child. The domains are:
  1. social development
  2. physical health and well-being
  3. emotional maturity
  4. language and cognitive skills
  5. communication skills and general knowledge.
How parents can help their young children develop healthy social skills
Credit: Australian Early Development Census
Each domain is essential for learning how to build friendships, though social development is the central one. The following table outlines what is considered developmentally on track, at risk or vulnerable in the social competence domain.
After reading this table, if you feel your child is developmentally at risk or vulnerable, there may be several reasons for this. Be guided by the educator at your preschool or  and care centre centre when deciding which service might best support your child to develop healthy social skills.
To help you, there are a broad range of services available. These include art and music therapists, dietitians, occupational therapists, speech therapists, physiotherapists, audiologists, and child counsellors.
Making friends through the stages of play
There is a range of research about stages of play a young child engages in when they’re learning to make friends. According to brain development research, a young child begins to develop pathways in their brain for social skills from birth.
According to research, there are six stages of play with associated social skills. These are assessed in the early childhood curriculum. The following stages and social skills are approximate and to be used as a guide only:
How parents can help their young children develop healthy social skills
Credit: The Conversation
Understanding some of these key indicators of social skills required to for play will help you consider their ability. Take time to observe your young child’s social interactions in a range of settings. Watch them at home, with family and friends, as well as in their preschool or early childhood education and care centre. This may help you determine if your child is engaging socially during play to make friends.
What’s next?
When a child moves from one educational setting to another, we call this movement a transition. Positive social development skills are an asset for your child during this time. Educators at both educational settings will work in partnership with you, and each other, to make sure the transition is as smooth as possible.
Essentially there are some key indicators which will help children during transitions: self-care, separating from parents, growing independence, and readiness to learn. As  you can:
  • familiarise your child with the new environment
  • engage in active listening as your child expresses their thoughts and feelings about starting in a new learning environment
  • ensure children start the new year with all required equipment recommended by the centre or school
  • arrange to meet other people starting in the new year and practice turn taking, listening, asking questions and asking for help before the  begins.
This will support development of social skills for your young  and help them make new friends more readily.