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Thursday, January 10, 2019

Piper sees Bausch Health as ‘stand out’ after management meeting


Piper Jaffray analyst David Amsellem reiterates an Overweight rating on Bausch Health Companies with a $27 price target after meeting with management. The analyst says commentary from the company reinforced his view that Bausch will continue to “stand out among the broader group of highly-levered specialty pharma names.” Management has high visibility into not only longer-term EBITDA stability but meaningful long-term growth, Amsellem tells investors in a research note. Significant growth from the gastroenterology franchise along with modest growth from the dermatology and eye care segments should translate into a long-term annual EBITDA growth at least in the mid-single digits, says the analyst

Wednesday, January 9, 2019

Progressive Lies Like “Free College” and “Medicare For All” Hide Cost of Debt


Steve Hanke and Stephen Walters discuss too good to be true socialist lies about free programs that hide the true costs.
Hats off to economists Steve H. Hanke and Stephen J.K. Walters for a brilliant op-ed in the Wall Street Journal on the true cost of “free” government programs.
This is written in guest post format, but it is an excerpt.
When politicians hide the cost of government, ‘free college’ and ‘Medicare for all’ sound like bargains.
For many politicians, lying prices are actually a goal. Policies that set dishonest prices or fudge budgets can fuel the growth of government and lure voters leftward. Sen. Bernie Sanders and his socialist followers use such sleight of hand to obscure the vast costs of proposals for “free college” and “Medicare for all.”
Recent history demonstrates that the price of each new government program rarely tells the whole story. In the past decade taxpayers were charged $27.2 trillion for federal services that cost $35.6 trillion, adding more than $9 trillion to the national debt. Our tax bills told us that Uncle Sam’s good works were about 26% cheaper than their real cost.
And Sam’s nose is growing thanks to rising deficit projections and the unfunded future costs of entitlements like Social Security and Medicare. Official projections put the present value of these two unfunded liabilities at $50 trillion over the next 75 years. Boston University economist Laurence Kotlikoff calculates that the total U.S. fiscal gap is more than four times that amount and that closing it would require a tax hike of more than 60%.
It is foolish to hope that the Democratic Party will join in reversing this trend any time soon. As it has moved left, it has embraced ever more deceptive prices for reforms to government services, labor (Fight for $15!), health care, higher ed, housing and much else.
This is a cynical strategy, and it creates a dangerous political feedback loop. First, progressive thinking leads to bigger, debt-financed government. But debt-financed government, and the lying prices it embodies, also can lead to more progressive thinking. Absent honest signals about government’s full costs, more voters are likely to shrug and assume it’s a good buy.
The late economist William Niskanen documented the relationship between deficits and spending, showing that attempts to “starve the beast” of big government via tax cuts don’t work: As tax receipts decrease, spending rises. In his words, “a tolerance for deficits leads to increased government spending.” Polls confirm this trend. Since 2011 the proportion of voters who worry “a great deal” about federal spending and deficits has fallen from 64% to 51%, while the national debt has risen 45%.
Before such tolerance for debt and a concomitant fondness for “freebies” afflicts a majority of the electorate, it would be wise for the party of Lincoln to seize the political, fiscal and moral high ground, steer clear of lying prices, and rebrand: Goodbye, Grand Old Party, and hello “Honest Abe Party.” Attempting to out-lie the Democrats is, in the long run, unlikely to be successful politically, and certain to be disastrous economically.
Steve H. Hanke and Stephen J.K. Walters
Mr. Hanke is a professor of applied economics at the Johns Hopkins University. Mr. Walters is a professor of economics at Loyola University Maryland.
Comments – Easy to Believe Lies
Socialists spout too good to be true nonsense. People believe economic nonsense for one simple reason: It is precisely what they want to believe.
The ideas get loonier and loonier. For example, ponder the Green New Deal by newly elected progressive illiterate Alexandria Ocasio-Cortez.
The radical plan would force families to pay more to heat, cool and provide electricity to their homes. It would raise the same costs for businesses, farmers, government and organizations, driving up their operating costs – and raising the prices for just about all the good and services Americans buy.
Under the Green New Deal, Americans would have to power their homes with renewable energy, such as wind and solar power. Every home and business in the United States would have to be “upgraded” for “state-of-the-art energy efficiency, comfort and safety.” And a slew of massive government social programs and mandates would be created.
Although no one knows exactly how much the Green New Deal would cost, a very conservative estimate is $40 trillion in its first 10 to 15 years. The Mercatus Center estimates the single-payer health-care proposal supported by Ocasio-Cortez would, on its own, cost more than $32 trillion.
Ocasio-Cortez has suggested one way to pay for these gigantic government programs would be to increase the income tax rate for America’s wealthiest earners as high as 70 percent, but even that radical move would fail to fund the Green New Deal.
Estimate vs Reality
The cost estimate to “save the planet” is $1 trillion. The reality is something like $40 trillion. Yet the Green New Deal has garnered significant attention and support from some members of the media, Congress, and even prominent senators considering 2020 presidential runs: Cory Booker, D-N.J.; Bernie Sanders, I-Vt.; and Elizabeth Warren, D-Mass.
This is precisely the kind of too good to be true nonsense that people want to believe. The message is powerful. We need to “save the planet”.
The idea is so absurd that even Pelosi can’t stand it. She put it on the back burner. But there is really only one reason Pelosi did so.
The plan is so idiotic that any Democrat running for president on that platform would lose.

Beta Bionics Secures $63M as AI-Driven ‘Pancreas’ Heads to Key Tests

Beta Bionics, a startup developing a medical device that monitors and manages blood sugar levels in diabetes patients, has closed $63 million to back late-stage clinical tests of its AI-powered technology.
The cash tops off a Series B round of funding announced last year. The Boston company, which counts diabetes drug giants Eli Lilly (NYSE: LLY) and Novo Nordisk (NYSE: NVO) among its investors and partners, says the capital will support Phase 3 studies of its device this year, and if all goes well, an application for FDA approval.
Beta Bionics’s device is designed to mimic the role of the pancreas, the organ that produces insulin and glucagon, two hormones that work together to maintain proper blood sugar levels. In type 1 diabetes, the immune system attacks the pancreatic cells that produce insulin, leading to low insulin levels and dangerously high levels of blood sugar.
Patients can manage their blood sugar with insulin therapy—self-administered injections or continuous infusions from an insulin pump. The Beta Bionics device, called iLet, is meant to replace these therapies. The system consists of a continuous glucose monitor worn on the skin that tracks glucose levels throughout the day. This monitor wirelessly sends readings to a handheld, smartphone-sized unit that houses cartridges for the hormones. This part of the device can be carried in a pocket. Like an insulin pump, the iLet administers the hormone via an infusion set that delivers its payload just below the skin. But Beta Bionics developed its technology to make all dosing decisions. After the patient’s weight is entered into the device, the algorithms take over. The company says iLet uses machine learning techniques to understand a patient’s blood sugar levels and determine when to administer hormones and how much to dose.
The iLet algorithms were licensed from Boston University, where they were developed in the lab of biomedical engineering professor Edward Damiano, the president and CEO of Beta Bionics. The company says that in earlier home-use studies in adults and children with type 1 diabetes, these algorithms showed that they can help manage patients’ blood sugar levels.
Beta Bionics isn’t the only company trying to improve upon insulin pumps. Medtronic (NYSE: MDT) won FDA approval in 2016 for MiniMed 670G, a device that uses algorithms to personalize its insulin doses. BigFoot Biomedical has developed an “artificial pancreas” technology that it says uses AI to optimize insulin dosing. The Milpitas, CA, startup’s system, which patients manage via a smartphone app, is still in clinical testing.
Beta Bionics designed its device with two chambers, one for insulin and the other for glucagon. The device can be configured to administer insulin only, glucagon only, or both. The company says glucagon-only administration could be used to treat rare, chronic, low-blood sugar conditions, such as congenital hyperinsulinism and insulinoma syndrome.
A Phase 3 study testing iLet’s insulin-only delivery is expected to begin in the second half of this year. The company says a second study testing delivery of both insulin and glucagon is expected to begin in late 2019 or early 2020.
Beta Bionics initially announced its Series B round last September, a $50 million financingthat was led by Eventide Asset Management. RTW Investments joined the funding along with Novo Nordisk, which had invested in the startup’s Series A round. Other investors in Beta Bionics include Eli Lilly and Denmark-based biotech Zealand Pharma (NASDAQ: ZEAL). Beta Bionics says new investors that joined the additional funding in the Series B round include Dexcom (NASDAQ: DXCM), which is a San Diego-based maker of continuous glucose monitoring systems, and funds managed by ArrowMark Partners and LifeSci Venture Partners.
https://xconomy.com/boston/2019/01/09/beta-bionics-secures-63m-as-ai-driven-pancreas-heads-to-key-tests/

NICE rejects Novartis’ migraine prevention drug Aimovig


Some migraine sufferers in the UK hoping to get access to Novartis’ new migraine prevention drug Aimovig are facing disappointment after NICE rejected it in draft guidance.
The cost-effectiveness watchdog says that it can’t recommend routine NHS use of Aimovig (erenumab) for people suffering at least four migraine episodes each month, even though it is only intended for use after three earlier oral treatments have failed.
Aimovig became the first drug in a new class of antibody-based CGRP inhibitors to be approved in Europe when it got a green light from the European Medicines Agency (EMA) last year, and is designed as a once-monthly, self-injected preventive treatment for migraines.
Since then Eli Lilly has won EU approval for its CGRP blocker Emgality (galcanezumab), while Teva is waiting for an EMA verdict on its fremanezumab candidate and Alder Biopharma is preparing a marketing application for eptinezumab.
Aimovig costs around £5,000 per year, although Novartis has offered the NHS a confidential discount, but NICE’s concerns seem to focus as much on deficiencies in the data generated in clinical trials as its price.
“The evidence shows that erenumab is a clinically effective treatment,” said NICE in a statement, but it added that “the trial evidence doesn’t fully reflect patients seen in clinical practice in the NHS and nor does it include all the relevant comparators and outcomes.”
“Because of this the cost-effectiveness estimates for erenumab are higher than what NICE usually considers to be acceptable when there is substantial uncertainty,” it added, noting in particular that there was not enough evidence to suggest it is more effective than that of Allergan’s Botox (botulinum toxin type A) for chronic migraine, which has been recommended for use after three failed treatments since 2012.
Novartis maintains people with chronic migraine have been waiting years for something “new, more effective and better tolerated”, pointing out that Botox “requires 31-39 injections into the head and neck in a clinic while Aimovig can be self-administered by the patient at home.”
The company’s managing director for the UK and Ireland – Haseeb Ahmad – described the decision as disappointing and said the company would be discussing its submission with NICE.
“If this decision remains unchanged patients will be denied access to the first licensed treatment specifically designed to prevent migraine in adults,” he added, suggesting NICE’s appraisals are flawed because they don’t take into account the impact of diseases on broader society when evaluating cost-effectiveness.
Novartis also says that as migraine predominantly affects people of working age, it costs the UK economy £8.8 billion per year in lost productivity alone.
Commenting on NICE’s decision, Meindert Boysen – director of the agency’s Centre for Health Technology Evaluation – said that “well-tolerated treatment options are needed [and] it’s therefore disappointing that we’ve not been able to make a positive recommendation for erenumab.”
“For both the chronic and episodic migraine populations there was no evidence to show that erenumab is effective in the long-term in people for whom three previous preventive treatments had failed,” he added.
That NICE draft guidance is out for comment until 31 January. Meanwhile, the Scottish Medicines Consortium (SMC) is scheduled to deliver advice on NHS use of Aimovig in Scotland in April.

Herbalife (HLF) Announces Michael O. Johnson as Interim CEO, After CEO Exit


The Board of Directors of Herbalife Nutrition Ltd. (NYSE: HLF) announced today that effective immediately, Michael O. Johnson, the Company’s Executive Chairman, who led Herbalife Nutrition Ltd. (“Company”) as its Chief Executive Officer from 2003 to 2017, will reassume the role of CEO on an interim basis following the resignation of current CEO Richard Goudis.
Mr. Johnson will oversee the operations of the Company, along with other senior executives, and continue to drive Herbalife Nutrition’s strong performance and growth trajectory. Pursuant to the Board’s succession plan, and to ensure an effective and orderly transition to a permanent CEO in the future, the Board expects to select the permanent CEO from the Company’s proven senior leadership team.
Mr. Goudis’ departure is not due to any issues regarding the Company’s financial reporting, but pertains to comments which recently came to light, made by Mr. Goudis prior to his role as CEO, that are contrary to the Company’s expense-related policies and business practices. The comments made were inconsistent with Herbalife Nutrition’s standards and do not reflect the Company’s culture.
The Company today also announced preliminary volume point results for the fourth quarter 2018 which were up 11.6% worldwide from the same period in 2017(1)( 2) and reaffirmed its initial full year 2019 guidance as announced on October 30, 2018, thereby demonstrating the Company’s consistent and continued confidence in the business moving forward.
(1) During 2018, the Company adjusted volume point values for certain products in Mexico, North America and South & Central America. Excluding these adjustments, the worldwide total year over year change in volume points would have been an increase of 10.8%.
(2) The volume point results are preliminary and may be subject to revision based upon the completion of the Company’s year-end financial closing process. The Company expects to report its final volume point results, as well as its financial results for the fourth quarter and full year 2018 and provide an update to 2019 guidance, on February 19, 2019.

Worrisome statistics around medical cannabis users operating vehicles


More than half of people who take medical cannabis for chronic pain say they’ve driven under the influence of cannabis within two hours of using it, at least once in the last six months, according to a new study.
One in five of them said they’d driven while ‘very high’ in the past six months, researchers from the University of Michigan Addiction Center report in the journal Drug & Alcohol Dependence .
Lead author Erin E. Bonar, Ph.D., assistant professor of psychiatry and a practicing clinical psychologist at the U-M Addiction Treatment Services finds the results of a survey of 790 Michigan medical cannabis users troubling.
Hundreds of thousands of Americans have state approval to use medical marijuana, including nearly 270,000 in the state of Michigan, according to Statista, as of May 2018. Michigan is second only to California for the highest number of medical marijuana patients in a state.
Risky driving
Bonar says that when people drive under the influence of marijuana their reaction time and coordination may be slowed down and they could have a harder time reacting to the unexpected. If they are in a risky situation, they could be more likely to be involved in motor vehicle crash, because they would not be able to respond as quickly.
For the study, the team surveyed adults in Michigan who were seeking medical cannabis recertification or a new certification for chronic pain in 2014 and 2015. The researchers asked about respondents’ driving habits for the past six months.
Fifty-six percent of participants reported driving within two hours of using cannabis, 51 percent reported they drove while a “little high,” and 21 percent reported driving while “very high.”
“There is a low perceived risk about driving after using marijuana, but we want people to know that they should ideally wait several hours to operate a vehicle after using cannabis, regardless of whether it is for medical use or not,” Bonar said. “The safest strategy is to not drive at all on the day you used marijuana.”
There is uncertainty about how marijuana could affect driving for chronic daily users, who might have even longer-lasting effects that linger in their system, Bonar added.
Uncharted territory
To add complexity to the issue, in November Michigan voters approved the use of recreational marijuana in the state. In early December, it became legal under state law for any Michigan resident over the age of 21 to use marijuana inside a private residence, and to grow up to 12 plants for personal use. Retail sales are only allowed for those with medical marijuana cards issued by the state. Marijuana use and possession remains illegal under federal law.
In light of this policy change, Bonar says, all cannabis users need a clear understanding of the side effects of this drug.
“When it comes to driving, we haven’t yet figured out the best way to know how impaired marijuana users are at any given time,” she says. “With alcohol, you can do some quick math based on the amount you drank, and take an educated guess at your blood alcohol level. For marijuana, an estimate like this would be complicated. It’s hard to quantify because there is a lot of variation in marijuana dosing, THC potency, and route of administration. We also don’t have specific guidelines yet about when exactly it would be safe to operate a vehicle.”
Bonar says the goal of her team’s study — conducted before the passage of the ballot question that resulted in the change in state law — is to help medical marijuana users to be safer on the roads.
“We believe more research is needed to inform a larger public education effort that will help individuals understand the risks for themselves, and others, of driving while under the influence of cannabis,” she says. “It is especially needed during this time of rapid policy change as many states are determining how to manage marijuana legalization. We also need clearer guidelines about marijuana dosing and side effects with an understanding of how individual differences in things like sex and body weight interact as well.”
This study was funded by the National Institute on Drug Abuse. The lead project investigator was Mark Ilgen, Ph.D., director of UMATS. Additional study authors include James Cranford, Ph.D., Brooke Arterberry, Ph.D., Maureen Walton, M.P.H., Ph.D., and Kipling M. Bohnert, Ph.D.
Story Source:
Materials provided by Michigan Medicine – University of MichiganNote: Content may be edited for style and length.

Journal Reference:
  1. Erin E. Bonar, James A. Cranford, Brooke J. Arterberry, Maureen A. Walton, Kipling M. Bohnert, Mark A. Ilgen. Driving under the influence of cannabis among medical cannabis patients with chronic painDrug and Alcohol Dependence, 2019; DOI: 10.1016/j.drugalcdep.2018.11.016

FDA Clears Epilepsy Smartwatch for Use in Children


The US Food and Drug Administration (FDA) has cleared for marketing the Embrace smartwatch (Empatica Inc) for seizure tracking in children as young as age 6.
The Embrace smartwatch detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers.
It was approved by the FDA for use in adults last February, as reported by Medscape Medical News.
“The clearance of the Embrace watch to detect seizures in children ages 6 years and older is an important step forward in our ability to identify seizures rapidly and thereby allow parents or others to respond,” Orrin Devinsky, MD, director at NYU Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery, said in a news release from the company.
More than 3 million people in the US have epilepsy, including around 300,000 children younger than age 14. About one quarter of all people with epilepsy have generalized tonic-clonic seizures, which are most often associated with sudden unexpected death in epilepsy (SUDEP).
Embrace improves the likelihood that a trusted caregiver will be there during the critical moments after a seizure happens. Having somebody present is associated with better health outcomes,” Empatica cofounder, chief scientist, and MIT professor Rosalind Picard, ScD, said in the release.
Embrace was tested in an epilepsy monitoring unit among 141 epilepsy patients, including 80 pediatric patients ages 6 to 21 years. Overall, 53 of 54 generalized tonic-clonic seizures were detected by Embrace for an accuracy rate of 98% during the clinical testing.