The FDA reported the approval of Mylan’s (MYL) Wixela Inhub, the “first generic” version of Advair, which is marketed by GlaxoSmithKline (GSK). The approval date for Wixela Inhub is January 30, according to a post to the FDA website that states: “‘First generics’ are just what they sound like-the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions
https://thefly.com/landingPageNews.php?id=2856215
Wednesday, January 30, 2019
Life Support Decision Aid Didn’t Improve ICU Patient Outcomes
A web-based decision tool failed to help family members, physicians, and other decision makers agree on treatment goals for patients on life support, or improve patient outcomes, according to results of a randomized trial.
Although patient surrogates who completed the decision aid showed better understanding of information conveyed by clinicians than control surrogates not exposed to the decision aid, both groups maintained expectations for their loved ones’ survival that were significantly more optimistic than those of clinicians or evidence-based clinical prediction models, reported Christopher E. Cox, MD, of Duke University in Durham, North Carolina, and colleagues.
The decision aid also failed to improve the surrogates’ psychological outcomes 3 and 6 months later, and the aids did not affect patient survival, hospital length of stay, or duration of mechanical ventilation, they wrote in the Annals of Internal Medicine.
Roughly 400,000 patients in the U.S. annually are subject to prolonged mechanical ventilation, with healthcare costs exceeding $35 billion, Cox’s group wrote.
Patients on life support typically lack the capacity to make critical decisions regarding life-prolonging therapy and comfort-focused care, so these decisions are left to family members or other close surrogates.
“Although experts encourage shared decision making for such preference-sensitive choices of a treatment plan that is most consistent with a patient’s values, clinicians often do not adequately elicit patient treatment preferences, provide guidance about the surrogate’s role, disclose likely long-term outcomes, and discuss the option of comfort care,” Cox and colleagues wrote. “As a consequence, family members struggle to make good surrogate decisions in the setting of heightened emotional distress and conflicting priorities.”
“Ineffective communication can result in the default provision of aggressive life support, which may conflict with patient preferences and lead to psychological distress among family members,” they noted.
While decision aids could, in theory, help guide care decisions in the mechanical ventilation setting, no previous clinical trials have examined their use in an acute care or ICU population, the researchers wrote.
Their multicenter trial examined the efficacy of a personalized, web-based decision aid designed to support surrogates and clinicians in shared decision-making for patients on prolonged mechanical ventilation.
“It was conceptually grounded in the Ottawa Decision Support Framework, which addresses how to support individual decision needs by highlighting options and risks, identifying uncertainty and clarifying health-related values,” the researchers wrote, adding that the aid was further constructed using guidelines from the International Patient Decision Aids Standards Collaboration and was written at a sixth-grade reading level.
The study’s primary outcome was improved concordance on 1-year survival estimates, measured with the clinician-surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality).
The researchers enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups for a mean difference in score change from baseline of 1.7 percentage points (95% CI 8.3-4.8 percentage points, P=0.60).
The authors also reported that surrogates’ postintervention estimates of patients’ 1-year prognoses did not differ between intervention and control groups: median 86.0% versus 92.5% (P=0.23) and were substantially more optimistic than results of a validated prediction model at a median 56.0% and physician estimates at a median 50.0%.
Also, 82 intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences.
Although intervention surrogates had greater reduction in decisional conflict than control surrogates for a mean difference in change from baseline of 0.4 points (95% CI 0.0-0.7 points, P=0.041), other surrogate and patient outcomes did not differ.
In an accompanying editorial, Aaron Tannenbaum, MD, and Scott Halpern, MD, PhD, both of Perelman School of Medicine at the University of Pennsylvania in Philadelphia, wrote that surrogate overoptimism about patient outcomes “may stem more from beliefs than knowledge.”
“Whether and how these beliefs are mutable may represent the true lynchpin to aligning expectations and enhancing the quality of surrogate decision making,” they wrote.
The editorialists highlighted the fact that 43% of surrogates rejected their own assessment of their patient’s treatment preferences, more often opting for survival-based treatment than comfort-based treatment.
“Although studies have shown that seriously ill patients often prefer function over longevity and rate certain states of debility as worse than death, surrogates may struggle to acknowledge such values,” they wrote. “If so, decision aids that provide more information and encourage greater deliberation may be insufficient. Indeed, the value of deliberation in clinical decision making is itself unsubstantiated.”
They conclude that while “Knowing may indeed be half the battle … future work that goes beyond decision aids will be needed to truly improve preference-sensitive decision making.”
The study was funded by the NIH.
Cox disclosed no relevant relationships with industry. Co-authors disclosed support from the NIH, the National Heart, Lung, and Blood Institute, and Biomarck Pharmaceuticals.
LAST UPDATED
Primary Source
Annals of Internal Medicine
Secondary Source
Annals of Internal Medicine
‘Lungs Donated After Opioid Overdose Do Well’
The growing number of donated lungs from people who died of opioid overdoses appear to fare as well as other donor lungs when they’re accepted for transplants, a study found.
Opioid overdose death donors provided 7% of the transplanted lungs from 2010-2017, up from 2% in 2000-2007. There was no significant difference in overall survival between transplant recipients who received lungs from opioid overdose death donors and other donors (P=0.174).
The findings say nothing about discarded lungs from these deceased donors. Still, “the ones we’re choosing aren’t doing worse,” and the study should spur discussions about whether more of these lungs should be used, said study co-author Neel Ranganath, MD, of NYU Langone Health in New York City.
The study findings were presented here at the annual meeting of the Society of Thoracic Surgeons.
For other organs too, the opioid epidemic is greatly boosting the number available for donation in the U.S.
However, Ranganath said, “while the opioid epidemic has contributed significantly to the organ donor pool, [the effect] has been less dramatic for lungs.”
The findings concur with those of a recent New England Journal of Medicine studysuggesting that non-discarded organs do not pose any extra safety risk to transplant recipients, noted Mandeep Mehra, MD, of the Center for Advanced Heart Disease at Harvard Medical School in Boston, who led that 2018 study.
For the new study, Ranganath and colleagues examined lung transplant statistics for the years 2000-2017 from the Scientific Registry of Transplant Recipient, excluding organs used in multiple transplants and those from donors who suffered cardiac death.
Over the 2010-2017 period, opioid overdoses were the fourth-most common cause of death in deceased lung donors, following hemorrhage/stroke (36%), blunt injury (23%), and gunshot wound (17%).
The researchers also found that donors who died from opioid overdoses were significantly younger than other donors (median age 29 vs 36) and more likely to have hepatitis C (0.8% vs 0.1%). “They’re also more likely to have a history of cigarette use and a more significant history of substance abuse,” Ranganath said.
About 25% of discarded lungs from these donors were positive for hepatitis C compared with 5% of other donors (P<0.001).
“We should make every effort to not discard these organs,” especially in light of the evolving treatment for hepatitis C, said Mehra, editor in chief of the Journal of Heart and Lung Transplantation. “In the past, we’ve been told as a transplant community that if someone has hepatitis C, walk away. Now we actually have very effective anti-hepatitis medication.”
Further research into the quality of lungs from donors who died of opioid overdoses is warranted, Ranganath said, especially in light of the possibility that they’re discarded for what he described as non-objective reasons. “Hopefully, it will show that more of these lungs can be used,” he said.
No study funding was reported.
Ranganath disclosed no relevant relationships with industry.
Hikma launches chemo agent
Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody’s / BB+ S&P, both stable) announces that Hikma Pharmaceuticals USA Inc., formerly known as West-Ward Pharmaceuticals Corp., has launched Mitomycin for Injection, USP, 20mg and 40mg.
Hikma’s Mitomycin for Injection, USP is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.
According to IQVIA, US sales of Mitomycin for Injection were approximately $43 millionin the 12 months ending November 2018.
Riad Mechlaoui, President of Injectables said, ‘We are excited to add Mitomycin for Injection to our oncology portfolio in the US, improving patients’ access to this important medicine. This demonstrates the successful execution of our strategy to expand our portfolio in key therapeutic areas.’
This new product introduction expands Hikma’s broad US offering of more than 90 injectable products and further solidifies our position as one of the top three suppliers of generic injectable products to US hospitals.
Elliott considering full-blown takeovers
Hedge fund Elliott Management is looking beyond activism to full-blown takeovers and has asked investors for $2B to take companies private, The Wall Street Journal reports. In its annual letter to investors viewed by the Journal, Elliott called activism and private equity a “powerful combination.” Elliott has pushed for change at companies that include Nielsen (NLSN), Sempra Energy (SRE) and Pernod Ricard (PDRDY), agreed in November to purchase Athenahealth (ATHN) for about $5.5B alongside Veritas Capital and offered to buy QEP Resources (QEP) this month. The firm was also previously near a deal to back a buyout of Arconic (ARNC) by Apollo (APO).
Blair trims Q4 eHealth estimate
eHealth, Inc. (NASDAQ:EHTH) – Equities researchers at William Blair dropped their Q4 2018 EPS estimates for shares of eHealth in a note issued to investors on Thursday, January 24th. William Blair analyst A. Klauber now expects that the financial services provider will post earnings per share of $1.60 for the quarter, down from their prior forecast of $1.70.
Biggest Thing Helping Office Real Estate Grow Is Fear Of Loneliness
The future of work and the workplace are a constant source of debate in real estate, because this will shape the future of offices, one of the two largest property sectors.
According to one academic study, offices have one key attribute to offer above all else. Forget about increasing productivity and efficiency. The main thing offices do is combat loneliness.
A recent episode of behavioural economics podcast Freakonomics looked at the open office, and why people dislike them so much. It took as its basis a study from researchers at Harvard which showed, contrary to received wisdom, that open offices actually reduce the amount of employee interaction.
But it also highlighted a second study, undertaken by economist Nicholas Bloom on behalf of the National Bureau of Economic Research titled “Does Working from Home Work? Evidence from a Chinese Experiment”. The staff of a division of Chinese online travel agency Ctrip, the Expedia of China, was randomly divided in two according to whether their birthdays were odd numbers or even. Half worked at home for nine months, while the other half continued to work in the office. The results were startling. The productivity of those working from home rose 13%, which meant they were doing almost a day a week of work more. Those working from home were also far less likely to quit, the study found.
“Part of this was they didn’t have the commute and have all that uncertainty,” Bloom told Freakonomics. “And they didn’t have to take sick days off. But the other big driver is it’s just so much quieter at home.
“The most amazing was the woman that told us about her cubicle neighbor who’d have endless conversations with her mum about medical problems, including horrible things like ingrown toenails and some kind of wart issue. I mean, what could be more distracting than that? Not surprisingly, in that case, the open office was devastating for her productivity.”
One downside of working from home was that people were less likely to get promoted — out of sight out of mind, Bloom hypothesised. But Bloom said it could be that those working from home often didn’t want to be promoted, because it would mean having to come into the office. The company was happy: the extra productivity and savings in office costs amounted to about $2K per employee over the nine months. And because of their extra productivity, employees were getting paid on average around 10% to 15% more if they worked from home.
And yet, when given the chance, 50% of those who had been working from home chose to return to the office. Why?
“The reason they told us is it was lonely at home,” Bloom said. The study found that some people had the right temperament, with those that performed well working from home more likely to carry on, and those that performed badly more likely to return to the office.
When positioning their office schemes, it seems, sociability should be paramount for investors and developers.
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