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Saturday, November 9, 2019

Best practice guide to quickly detect, treat vaping-associated lung injury

As the outbreak of lung injuries and deaths associated with e-cigarettes, or vaping, continues to spread across the U.S., researchers at Intermountain Healthcare in Salt Lake City have effectively developed a best practice treatment guide to quickly identify and treat patients who develop the new and potentially fatal respiratory injury, according to a new study.
“This is still an ongoing outbreak, and not something we’ve seen with vaping before,” said Denitza Blagev, MD, a pulmonary and critical care physician at Intermountain Healthcare, who is the lead author of a new study that outlines best practices for treatment for patients with e-cigarette or vaping-associated lung injury (E-VALI).
The study is published in the November 8, 2019, issue of The Lancet, one of the world’s best-known and most prestigious peer-reviewed medical journals.
The lung injury diagnosis and treatment guidelines developed by Intermountain Healthcare clinicians are based on the cumulative clinical experience of treating more than 60 patients throughout the health system’s 24 hospitals and 215 clinics.
The Intermountain guidelines recommend shorter courses of moderate-dose steroids for patients who are either treated as outpatients, or admitted to hospitals, and higher doses of intravenous steroids that are tapered more slowly for patients who are critically ill on admission. Clinicians also recommend close outpatient follow-up, as complications after initial recovery are recognized.
“Through sharing the guideline, we’re reaching clinicians and keeping e-cigarette or vaping-associated lung injury on everyone’s minds, especially as we enter flu season and diagnosing vaping associated lung injury becomes more challenging,” said Dr. Blagev.
We now have a standardized approach to treat these patients, and we’re starting to learn about what the recovery and complications are. Time will show us the long-term outcomes and the cause of this new disease, but in the meantime, the surest way to prevent lung injuries associated with e-cigarettes, or vaping, is not to vape.”
Denitza Blagev, lead author of new study
In the study, Intermountain Healthcare researchers identified 60 E-VALI patients at 13 different Intermountain hospitals or clinics in Utah from June 27, 2019, through October 4, 2019. The diagnosis was defined by a history of vaping or e-cigarette use within 90 days prior to symptoms, abnormalities shown in chest imaging, and no other cause for these findings (such as pneumonia).
While the majority of E-VALI patients were admitted to an intensive care unit, many weren’t critically ill and recovered more quickly. These patients typically had flu-like symptoms, shortness of breath, cough, chest pain, and abdominal symptoms such as nausea, vomiting, and abdominal pain.
Most patients with lung injuries associated with e-cigarettes or vaping were treated with antibiotics (due to overlapping pneumonia symptoms), oxygen, and steroids. While specific infectious disease testing was negative for all of the patients, most received antibiotics, researchers reported.
The Intermountain clinicians attribute the clinical improvement of the patients’ health to the positive effect of the steroids they received. Most patients started to show improvement within days, researchers noted, however, six of the patients — or 10 percent of those enrolled in the study — relapsed and had complications that required hospital readmission.
The majority of patients who were readmitted to the hospital had been critically ill when they initially came in for care, and half of them had resumed vaping after discharge, researchers reported in the Lancet study.
In the first study to report follow-up findings for these patients, Intermountain clinicians performed a short follow-up exam after two weeks and found that, although most patients had improved significantly, many had residual abnormalities. Only 23 percent of the patients still needed supplementary oxygen, but most still showed some signs of lung abnormalities on their imaging and breathing tests.
These findings are helping physicians recognize what lung injuries associated with e-cigarettes or vaping look like — and helping them maintain a high degree of suspicion when they diagnose lung injuries in patients who’ve been vaping.
“Being vigilant about obtaining a patient’s vaping history when they’re admitted and keeping it in mind throughout their hospital stay, is essential,” said Dr. Blagev. “For some patients in our study, their vaping history didn’t emerge until they were well into the course of their disease.”
While the majority of E-VALI patients vaped THC, some reported only vaping nicotine. Intermountain researchers reported no clear pattern emerged in terms of vaping device or the source of the vaping liquids among the patients. Patients in the study reported obtaining vaping e-liquids from local dealers or vape shops, friends, or social medial apps.
Without a known cause of e-cigarette or vaping-associated lung injury, current recommendations are to avoid all e-cigarette or vaping exposure, Intermountain researchers advised in the study.
According to the U.S. Centers for Disease Control and Prevention, 1,888 cases of e-cigarette or vaping-associated lung injury have been reported in the United States, including 37 deaths in 24 states.
In Utah, 109 cases of E-VALI have been confirmed, with another seven cases under investigation in the state, as of Oct. 28.
Dr. Blagev and her colleagues at Intermountain began to see E-VALI patients early last summer. The first case at Intermountain was recognized by pulmonologist Dixie Harris, MD, who, through her work in the Intermountain TeleHealth Critical Care service, noticed a cluster of patients seeking treatment at multiple Intermountain hospitals throughout Utah.
The Intermountain TeleHealth Critical Care service is a systemwide proactive monitoring and response center where intensivist physicians and critical care nurses monitor data on large patient populations and provide clinical decision support remotely as bedside staff care for individual patients in hospitals throughout the Mountain West.
The Intermountain TeleHealth Critical Care service allowed the rapid formation of a centralized task force, which enabled tracking and public reporting of cases, and sharing of clinical expertise among clinicians, according to the study.
“The use of the TeleHealth Critical Care service allowed us to recognize the outbreak much earlier than if we had only relied on reports of separate cases in individual hospitals,” Dr. Blagev noted.
Intermountain Healthcare is a not-for-profit system of 24 hospitals, 215 clinics, a Medical Group with 2,500 employed physicians and advanced practice clinicians, a health insurance company called SelectHealth, and other health services in Idaho, Utah, and Nevada.

Supernus needs to fill gap left by faltering epilepsy drug Trokendi XR; SPN-810 won’t

The past year has been tough for Supernus, and things are getting worse. The demise of the group’s biggest seller, Trokendi XR, looks to be approaching even more quickly than expected, and the company needs its pipeline projects to step into the breach.
Unfortunately for Supernus one of its hopefuls, the ADHD aggression candidate SPN-810, now looks like a dead duck. The asset had been expected to pick up the slack after Trokendi XR’s upcoming patent expiry, and with few other bright spots on the horizon Supernus might now have to look externally for growth.
A DIMMING OUTLOOK FOR SUPERNUS
Annual sales ($m)
Product/projectIndicationStatus20182024e
SPN-810ADHD impulsive aggressionFailed first phIII336
SPN-812ADHDFiling imminent281
Oxtellar XREpilepsyMarketed85261
Trokendi XREpilepsy, migraineMarketed31567
SPN-604*BipolarPhIII
SPN-809DepressionPhII ready
SPN-817EpilepsyPhI
*Same active ingredient as Oxtellar XR; Source: EvaluatePharma, company presentation.
Investors do not seem convinced of the company’s chances of getting out of its current hole: Supernus’s stock, which had already fallen 30% since this time last year, is down 31% so far today after the double whammy of disappointing Trokendi third-quarter sales and the news of SPN-810’s phase III failure.
However, the company refuses to be rushed into making a deal. During a conference call today its chief executive, Jack Khattar, said Supernus had long been looking for business development opportunities, but had not found any late-stage assets that would create value.
He added that the group did not want to end up overpaying for a deal. But bargains in the CNS sector are few and far between and Supernus, while well funded, does not have a huge amount of firepower, with $893m in cash and equivalents at the end of the third quarter.
Not so Super
Still, the company might need to do something soon after SPN-810, a dopamine antagonist, flunked its first pivotal test, the P301 trial. The study, in patients aged 6-11 with ADHD and impulsive aggression, did not meet its primary endpoint, the average weekly frequency of impulsive aggression episodes versus placebo: these fell by 59% and 48% with SPN-810 dosed at 36mg and 18mg respectively, compared with a 43% decline in the placebo arm.
Supernus claimed a statistically significant decrease in episodes with the higher dose of SPN-810 at the time of an interim analysis, citing a p value of 0.029 versus placebo. The company blamed variability in the latter part of the trial for the primary endpoint miss.
It is unclear whether the group will use this finding to justify pressing ahead with SPN-810. Data from a second phase III trial, called P302, should soon make the picture clearer: Supernus has stopped enrolment into that study early, at 98% of its target, and results are now due by the end of 2019. Mr Khattar said the company would consider the total data package before making a decision.
Supernus needs SPN-810 to be a hit. It is due to file another non-stimulant ADHD candidate, SPN-812, in the US this month, but even if this is approved its commercial prospects are far from certain.
Three of four pivotal trials of SPN-812 read out positively. But the project has not been shown to be any better than Lilly’s non-stimulant ADHD drug Strattera, which lost patent protection in 2017, so could find it tough to compete (Supernus struggles to gain attention, March 28, 2019).
Talking of intellectual property, Trokendi XR is set to lose exclusivity in 2023, leaving Supernus limited time to find something to plug the gap. The group hopes to expand its epilepsy therapy Oxtellar XR into bipolar disease, where this is codenamed SPN-604, but there is no escaping the fact that, if SPN-810 is removed, the company’s pipeline looks thin.
Supernus’s last acquisition, a $15m bet on Biscayne Neurotherapeutics, was hardly a game-changer. The company now needs to make a more decisive move.

Google To Buy Fitbit For $2.1 Billion: What About Privacy Concerns?

Fitbit is getting Googled, in more ways than one.
That’s because there was a Fitbit of news on Friday. Google, a company that you may have heard of, will be acquiring Fitbit, Inc., which has been a pioneer in the wearable-technology and fitness tracker market. According to a Fitbit press release, the deal will go down for $7.35 per Fitbit share, which amounts to about $2.1 billion.
This will certainly help Google get a leg up, or an arm up, or wherever-you-happen-to-wear-your-wearable up, on the rest of the wearable technology market. Google, which is owned by Alphabet, certainly won’t be the only player in the market and would have to catch up to Apple, Samsung, and others in many ways. But it is kind of nice when you can just buy a leading fitness tracker company to do so.
In a blog post, Rick Osterloh, Senior Vice President of Devices and Services for Google, described the impending acquisition as “an opportunity to invest even more in Wear OS as well as introduce Made by Google wearable devices into the market.” He indicated that “By working closely with Fitbit’s team of experts, and bringing together the best AI, software and hardware, we can help spur innovation in wearables and build products to benefit even more people around the world.” Indeed, with the deal, Alphabet-owned Google will be acquiring Fitbit’s product line that includes activity trackers such as the Fitbit Charge 3™, Fitbit Inspire HR™, Fitbit Inspire™ and Fitbit Ace 2™, smartwatches such as the Fitbit Ionic™ and Fitbit Versa™, wireless headphones such as the Fitbit Flyer™, and smart scales such as the Fitbit Aria.
Today In: Innovation
Ah, but that’s not all that they’ll be getting. There’s also going to be lots and lots and lots of, drum roll please, data.
In a statement for the press release, James Park, co-founder and CEO of Fitbit, said, “We have built a trusted brand that supports more than 28 million active users around the globe who rely on our products to live a healthier, more active life.”
That’s 28 million users continuing to generate lots and lots of data as they sleep, sit, move, poop, and do who knows what else while wearing their Fitbit devices. Twitterer @lutherlowe outlined some of these data elements here:
A number of other members of the Twittersphere expressed privacy concerns about the deal and felt that it was more about getting the data than the hardware such as @GerberKawasaki:
And @rockdem0n:
And @ireneista , who claimed to have been a Google insider:
As @journeydan pointed out, Osterloh’s blog did sort of address some of the privacy concerns:
And so did Fitbit and the Fitbit press release:
But not everyone seemed so “reassured”:
In fact, here’s what @neilcybart felt about these “reassurances”:
Fitbit could grow its customer base in part through consumer trust that its data was not being used and sold for advertising and other purposes:
But that was when Fitbit was a smaller company, at least much smaller than Google, which applies to many companies. It will be interesting to see how this news affects the purchases and uses of Fitbit devices:
There was talk of this as being a “privacy apocalypse”:
And that one company would have too much control over everyone’s personal and health data:
Certainly acquiring Fitbit will give Google a whole new data source. A lot of the data will be messy, so-called Big Data in that it will be volumes and volumes of data, not all of which will be accurate or provide value. But there’s no denying that this will be more personal data and information on people’s health.
So what are the concerns about having such personal and health data all in one place? One is further targeting by advertisers. If you thought that gym ads appearing on your computer screen after you have searched for “I have got the runs” was creepy, what does the future have in store for you? Here’s one possibility:
Waiting for the day that your device will say, “you’ve been on the toilet for a really long time, and your heart rate seems to increase periodically. Here are a bunch of stool softeners that you can buy.”
Another is such data being offered to employers, insurance companies, financial firms, and others who may be interested in knowing people’s health and disease status. Could a company be less inclined to hire, insure, offer credit to, or invest in you if you have certain “pre-existing conditions” or are deemed by an algorithm as a “health risk”? How may your promotions and career advancement be affected? What products, services, and discounts will you have or not have access to given your health status? Could a hotel in the future say, “oh, we’d love to give you a room for that price but it looks like you haven’t gotten that much sleep over the past few days, so we’re going to charge you a premium since we know that you need it.”
As you can see, health data can be powerful, more powerful than knowing how many times you listened to a Justin Bieber song. Because your health can determine what you can and can’t do. It can determine your vulnerabilities, your limitations, or at least what others view as your vulnerabilities and limitations.
Moreover, even if a person’s health is not a limitation or a vulnerability, it can be turned that way. Stigma and discrimination come with many mental and physical health issues. People can even use perceptions of mental and physical health issues against each other. Heck, I’ve seen people make up mental health issues just to besmirch someone else. If you haven’t realized, workplace politics can be quite dirty.
Additionally, even if there isn’t intentional use or selling of such data, the risk of hacking or accidental data leakages and security lapses are always issues. One can talk about taking data security seriously but it will be important to know what specific security measures are in place and how will they be enforced. Health researchers and data scientists like myself regularly deal with such data issues. Whenever we do a study or work with health data, we have to go through a range of safeguards to ensure that sensitive data is safe and that individuals cannot be identified.
Then, there’s the potential problem of data being used improperly even if the intentions are good. Data in itself has no value. It’s use determines its value. Therefore, the methodology and analytical approaches applied do matter. Three different researchers can take the same data set and potentially generate different insights depending on the methods used. If you are wondering how this could happen, just look at opinions about coffee over the past decade. Is coffee good or bad for you? It can depend on how you slice the data (and the bagel that goes with it).
All in all, Google’s acquisition is big data news in more ways than one. Certainly, Google and whomever they share the data with will get more Big Data. But the acquisition is also big, big, big as far as data and data science are concerned. Health data can be powerful in many different ways, and how it is used will make a big difference. Used positively, it can help identify new ways of preventing and treating health problems and helping people live happier and more productive lives. Used in nefarious or inappropriate ways, it can create a lot more problems, bigger problems than just offering you uninvited recipes for chocolate pie.

1 biotech on the IPO calendar next week

NASH biotech 89bio (ETNB) plans to raise $85 million at a $225 million market cap. The company’s target indication represents a multi-billion-dollar market with no FDA-approved therapy; consequently, there are many other NASH-focused biotechs, most of which are later-stage. NASH biotechs as a whole have not done well, save for June IPO Akero Therapeutics (AKRO; +28% from IPO). A holdover from last week, the company delayed its offering due to a minor issue with its auditor’s disclosures to the SEC.
A few companies in the IPO pipeline could launch this week, including mortgage lender Velocity Financial (VEL), social media manager Sprout Social (SPT), and Chinese consumer debt collector YX Asset Recovery (YX.RC).
Street research for BellRing Brands (BRBR) and Innate Pharma (IPHA) is expected on Monday, and lock-up periods will be expiring for five companies: Applied Therapeutics (APLT), Postal Realty Trust (PSTL), Avantor (AVTR), Fastly (FSLY), and Luckin Coffee (LK).
U.S. IPO CALENDAR
ISSUER
BUSINESS
DEAL SIZE
MARKET CAP
PRICE RANGE
SHARES FILED
TOP
BOOKRUNNERS
89bio (ETNB)
San Francisco, CA
$85M
$225M
$16*
5,304,687*
BofA
Leerink
Phase 1 biotech developing therapies for NASH and other metabolic diseases.
*based on 11/8/19 S-1MEF

Haven partners with traditional payers in plans offered to Amazon, JPM workers

  • J.P. Morgan Chase and Amazon have begun offering employees in select states health insurance through Haven Healthcare, the joint venture the two companies and Berkshire Hathaway launched early last year, per initial Bloomberg reporting confirmed by Healthcare Dive.
  • Amazon is currently offering 2020 plans for its workers in Connecticut, North Carolina, Utah and Wisconsin, and JPM is offering the plans in Ohio and Arizona.
  • The JPM-Haven plans, run by payers Cigna and Aetna, don’t require employees to pay deductibles and do offer financial rewards for fulfilling certain wellness activities like keeping blood pressure below target levels, according to Bloomberg. Co-pays range from $15 to $110 for a majority of services, though higher acuity care like hospitalization is more expensive.

The Boston-based nonprofit venture, which has an office in New York, has spooked established players fearful of potential disruption. The three companies have a combined 1.2 million U.S. employees.
However, this initial rollout in tandem with traditional health insurers like Aetna, now part of CVS, and Bloomfield, Connecticut-based Cigna could assuage some of those worries.
Details about Haven have been scarce since the beginning. In March, the trio launched a website with vague ideas of what it would be focusing on, like leveraging technology and looking at common-sense fixes to lower employer healthcare costs.
Employer-based insurance covers more than 55% of the country, according to census data, and traditional healthcare players have long urged businesses to get off the sidelines and do their part to lower skyrocketing healthcare spending.
Some Amazon employees are already enrolled in the plans created in consultation with Haven and insurance providers. JPM plans to look at how the new offerings perform to see whether employees find it more transparent, according to Bloomberg. Berkshire Hathaway did not respond to a request for comment.
“Amazon regularly pilots new benefits and services to best meet the needs of our employees,” an Amazon spokesperson told Healthcare Dive.
Helmed by Harvard Medical School professor and New Yorker author Atul Gawande, Haven includes a powerhouse team of healthcare execs, including former UnitedHealth and Comcast executive Jack Stoddard as COO, ex-SVP of enterprise analytics at BCBS Massachusetts Dana Gelb Safran and former Optum exec David Smith as director of product strategy and research.

Tenet posts 3rd consecutive quarter of volume growth

  • Shares of hospital chain Tenet Healthcare rose more than 3% Tuesday morning after reporting its third quarter results Monday evening showing broad-based volume growth.
  • Comparing hospital-to-hospital performance, Tenet reported a 3.6% increase in admissions and a slight uptick for inpatient surgeries (1.9%) and outpatient visits (1.6%).
  • The Dallas-based company reported a net loss of $232 million for the quarter attributable to the company’s common shareholders, compared to a loss of $9 million a year earlier.

Tenet CEO Ronald Rittenmeyer touted the results on Tuesday’s call with investors and said the company is raising its outlook for the year based on the numbers.
“We had a very positive third quarter with performance improvement in each of our operating segments,” Rittenmeyer said in a statement.
It’s the third consecutive quarter of volume growth, executives said Tuesday.
Rittenmeyer attributed positive trends over the past few years to a strong leadership team. “Tenet is in a much different place than it was two years ago,” he said.
Same-hospital patient revenue grew 5.8% and surgical revenue increased 6.9% on a same-facility basis.
Commercial volume trends were also very positive, executives said.
Still, they said the company faced more than $50 million in unanticipated headwinds including closures and costs related to Hurricane Dorian, lower California provider fee revenues and costs related to a nursing strike at 12 facilities.
The company is raising its outlook for adjusted earnings per share for the year. It expects adjusted diluted earnings per share from continuing operations of $2.25 to $2.91 for the year.
The company’s other segments also showed growth.
Conifer, the revenue cycle management unit, reported adjusted EBITDA of $90 million, an 11% increase from the previous year period. Tenet announced earlier this year it will spin off Conifer into an independent publicly traded company by the second quarter of 2021.
USPI, the outpatient surgical business, has a steady pipeline of health systems willing to send patients to the outpatient facilities, executives said during the call. During the third quarter, the company added three health systems and expects to reach a total of seven by end of year.

Consumers more likely to leave Obamacare after their insurer exits

  • When insurance companies left the Affordable Care Act marketplace between 2015 and 2018, their existing enrollees were more likely to leave the ACA than consumers whose insurers continued to sell policies on the exchange, a new study in Health Affairs suggests.
  • And the impact of an insurer’s decision to exit the ACA marketplace was twice as large for consumers who did not qualify for federal subsidies that cap premium payments based on income as it was for consumers who did receive subsidies.
  • The study also found that premium increases were larger in geographic areas where the number of insurers competing on the ACA marketplace dwindled, compared with areas of robust competition. Not surprisingly, consumers living in areas with less competition among insurers — and higher premiums — were more likely to leave the marketplace than their peers in areas with competitive marketplaces, the study found.

The online ACA marketplaces, which debuted in 2014, were envisioned by policymakers as places where consumers could buy affordable insurance policies. This year, 39 states are using the federal government’s online ACA marketplace, while the other states and Washington, D.C. operate their own version.
The study in Health Affairs focuses on participation in the federal government’s exchange, Healthcare.gov, where competition among insurers declined in 2017 and 2018 to the point where 29% of returning shoppers in 2018 had to choose a health plan from one insurer, the study’s authors wrote. Premiums also increased substantially during that two-year period.
The study analyzed data on 13.3 million consumers eligible to re-enroll in a plan offered on the ACA marketplace from 2015 to 2018.
Other reports have studied which consumers buy insurance plans sold on the ACA marketplaces.
Between 2016 and 2018, there was a 2.5-million drop (or 24% decline) in unsubsidized consumers buying plans on the ACA, according to a report from CMS released earlier this year. During the same period, enrollment among people receiving subsidies increased 4%.
The authors of the Health Affairs study highlighted the impact of marketplace competition on the rate of premium increases, and presumably the affordability of these plans for unsubsidized consumers.
In 2017, for example, unsubsidized consumers who lived in areas where competition on the federal ACA marketplace was limited to one or two insurers faced an average premium increase of $136 per month for the lowest-cost silver plan. But unsubsidized consumers who lived in geographic areas with three or more insurers saw their average premium for the same types of plans increase by an average of $56 per month, the study found.
Consumers eligible for subsidies had the opposite experience. In areas that became less competitive, the average amount that they would pay in premiums decreased by $7 per month in 2017 and $13 per month in 2018. But their peers in competitive markets saw their premiums increase by $1 per month in 2017 and decrease $3 per month in 2018.
This phenomenon happens because insurers that remain in the marketplace set what is known as the benchmark premium, which then determines the amount of federal subsidies, the authors note.
“In this study we found that continued insurer participation could be one method to help maintain both stable Marketplaces and competition to limit premium increases,” they concluded.