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Wednesday, September 4, 2019

Georgetown U tobacco control expert outlines motivations of Altria-Juul deal

The pending deal for Altria to purchase 35% of Juul Labs should serve as a “wake-up call” for the careful monitoring of competition in the nicotine delivery market, and for evaluating how regulations and policies impact cigarette and non-cigarette firms selling alternative nicotine delivery products, says a Georgetown University professor. Juul Labs, the largest US seller of vaping products, would merge with Altria, seller of Marlboro cigarettes and a leading seller of smokeless tobacco.
Writing in BMJ (Open Access), David Levy, PhD, professor of oncology at Georgetown Lombardi Comprehensive Cancer Center, and colleagues explore the motivations of Altria in buying Juul Labs and the motivations as to why Juul would accept the offer.
“While Juul Labs has clear motivations for the deal, Altria’s motivations to pay $12.8 billion for a non-controlling stake are less clear,” write Levy and his colleagues.
The researchers also explore the future impact of the deal on the US cigarette and alternative nicotine delivery markets and on public health.
“From a public health perspective, the impact of this deal will depend on whether it leads to increased cigarette use, less cigarette use, or an increase of e-cigarette use instead of cigarettes,” explains Levy.
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In addition to Levy, authors include: David Sweanor (University of Ottawa), Luz Maria Sanchez-Romero (Georgetown Lombardi), Richard O’Connor (Roswell Park Cancer Institute), Maciej Lukasz Goniewicz (Roswell Park Cancer Institute), and Ron Borland (University of Melbourne). The authors received funding from the National Cancer Institute (P01CA200512 and U54CA229974). Goniewicz reports receiving a research grant and serving as an advisory board member to pharmaceutical companies that manufacture smoking cessation medications. The other authors report no potential conflicts.
Georgetown Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute (NCI) as a comprehensive cancer center. A part of Georgetown University Medical Center, Georgetown Lombardi is the only comprehensive cancer center in the Washington D.C. area. It serves as the research engine for MedStar Health, Georgetown University’s clinical partner. Georgetown Lombardi is also an NCI recognized consortium with John Theurer Cancer Center/Hackensack Meridian Health in Bergen County, New Jersey. The consortium reflects an integrated cancer research enterprise with scientists and physician-researchers from both locations. Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic, translational and clinical research, patient care, community education and outreach to service communities throughout the Washington region, while its consortium member John Theurer Cancer Center/Hackensack Meridian Health serves communities in northern New Jersey. Georgetown Lombardi is a member of the NCI Community Oncology Research Program (UG1CA239758). Georgetown Lombardi is supported in part by a National Cancer Institute Cancer Center Support Grant (P30CA051008). Connect with Georgetown Lombardi on Facebook (Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer).
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Pain medication use by children after common surgeries

Bottom Line: About 400 caregivers reported pain medication use by children after common surgeries such as hernia, elbow fracture, appendectomy or adenoid removal in this study. Most reported using acetaminophen or ibuprofen or both; 88 patients (22%) were prescribed an opioid at hospital discharge and most used less than prescribed. The lack of an opioid prescription wasn’t associated with poor pain control, a postdischarge opioid prescription or a pain-related visit to an emergency department for patients. Limitations of the study include that it was conducted at a single center and patients weren’t randomized.
Authors: Calista M. Harbaugh, M.D., M.S., University of Michigan, Ann Arbor, and coauthors
(doi:10.1001/jamasurg.2019.2529)
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CVS Health rises on favorable court ruling in Aetna deal

CVS Health (NYSE:CVS) +1.2% after-hours on news that a federal judge reviewing a U.S. Department of Justice decision to allow the company to merge with Aetna said the agreement was in fact legal under antitrust law.
The judge initially had balked at approving the merger conditions and insisted on hearing from critics of the deal, but finally decided to grant the motion to approve the consent agreement while also criticizing the common practice of companies’ closing multi-billion-dollar deals while the court review, required by the Tunney Act, was still in process.
“CVS Health and Aetna have been one company since November 2018, and today’s action by the District Court makes that 100% clear,” CVS says.
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Vast majority of dementia patients don’t receive specialty diagnosis and care

In the first large study to examine the diagnosis of dementia in older Americans over time, researchers found the vast majority never meet with a dementia specialist and are instead overwhelmingly diagnosed and cared for by non-specialists.
Researchers at USC, Johns Hopkins and the University of Washington used Medicare data to track dementia diagnoses of nearly a quarter of a million people over five years. The team found 85% of individuals first diagnosed with dementia were diagnosed by a non-dementia specialist physician, usually a primary care doctor, and an “unspecified dementia” diagnosis was common.
One year after diagnosis, less than a quarter of patients had seen a dementia specialist. After five years, the percent of patients had only increased to 36%.
The study, which also found the use of dementia specialty care was particularly low for Hispanic and Asian patients, was published today in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.
“Dementia specialists are more familiar with subtypes of dementia and may be less likely, for example, to misdiagnose Lewy body dementia as Alzheimer’s disease and wrongly prescribe antipsychotic medications to patients,” said co-author Julie Zissimopoulos, director of the Aging and Cognition program at the USC Schaeffer Center for Health Policy & Economics.
Differences in diagnosis and follow-up care
Using a large Medicare dataset, researchers examined the types of physicians that diagnose dementia, what dementia subtype diagnoses were initially provided and how they changed over time, the extent to which individuals accessed specialty care and how it varied by gender, race and ethnicity.
They found that, among those diagnosed by a non-dementia specialist, 33% of patients were given a diagnosis that lacked a specific type of dementia, compared to 22% of patients diagnosed by a specialist. Diagnoses of Alzheimer’s disease among patients who saw a specialist within the first year of diagnosis were higher at 42% compared to 29% among those who did not see a specialist. Dementia specialists include neurologists, psychiatrists, neuropsychiatrists and geriatricians.
“Without identification of dementia type, patients and their families are potentially missing out on important discussions about care and managing this diagnosis with other chronic conditions, as well as information about clinical trials,” Zissimopoulos explained.
The team also found Hispanic and Asian patients were less likely to have a follow-up visit about the diagnosis compared to white and African-American patients. Approximately 37% of Hispanics and 40% of Asians with an initial diagnosis had no follow-up care within the first year of diagnosis, compared to whites and African Americans who each had a rate of about 33%.
The research team said more study is needed to identify factors driving these differences, such as severity at diagnosis, complexity of the care and barriers or differences in seeking care from specialists.
The importance of dementia subtypes
There are many different types of dementia, including Alzheimer’s disease, vascular dementia and frontotemporal dementia. Study authors say that more accurate identification of dementia type may lead to better treatment for symptoms, enhance knowledge of medications that may worsen symptoms, inform disease progression over time and encourage advance care planning.
Identifying dementia subtypes can also assist in developing and evaluating new drugs and gaining access to effective treatments when they become available.
“While the study shows that specialists seem to be able to identify the subtype better, what we’re really interested in is whether that leads to  and financial outcomes,” Zissimopoulos said. “If in the future these diagnoses are going to be handled in large part by non-dementia specialists, they may need better training and tools.”
An aging population, a rapidly growing toll
The toll of Alzheimer’s disease and other dementias is high and rapidly growing as the population ages. Dementia affects approximately 7 million America and is projected to grow to nearly 12 million over the next 20 years, driven by an aging population and increased life expectancy. The research team pointed to a recent Alzheimer’s Association survey that found only half of seniors are being assessed for dementia despite the fact that screenings are now reimbursable services.
Market factors may also drive dementia specialist health care use. For example, the research team found 3.9 neurologists for every 100,000 residents in the zip codes of beneficiaries who never saw a dementia specialist in the first year after diagnosis. In contrast, they found 5 neurologists for every 100,000 residents among beneficiaries who had a specialist visit. The researchers note that low rates of dementia specialist care are consistent with recent findings about regional U.S. neurologist shortages.
The study authors explain that their results don’t answer the question of whether or not increasing use of dementia specialist health care should be a policy goal. They say use of specialist services may increase health care costs and, without enough evidence that they improve health outcomes, they may not be a cost-effective approach to dementia care.
“Non-specialists and specialists may be complementary in dementia diagnosis and care,” Zissimopoulos said. “General practioners and other nondementia specialists play an important role in screening because often they are the first point of contact, while specialists are key to making finer distinctions across dementia subtype.”
The researchers say the study’s findings will aid in efforts to improve —especially among patients and families not receiving timely post-diagnostic care or  specialist care—and inform efforts to better target resources to physicians and improve the preparation necessary to link patients to appropriate new treatments as they become available.
Explore further
More information: Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, DOI: 10.1016/j.jalz.2019.07.005 , https://www.alzheimersanddementia.com/article/S1552-5260(19)35126-X/fulltext
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Baylor study: E-cigarettes disrupt lung function and raise risk of infection

A study led by researchers at Baylor College of Medicine raises health concerns about the use of electronic cigarettes. Published in the Journal of Clinical Investigation, the work shows that chronic exposure to e-cigarette vapors disrupts normal lung function in mice and also reduces the ability of immune cells residing in the lungs to respond to viral infection. These alterations were observed with vapors without nicotine, warranting deeper investigations on the effects the allegedly safe-to-use solvents in e-cigarettes have on people.
“E-cigarettes currently are the most commonly consumed tobacco substitute in the adolescent population. More than 3 million high school age adolescents as well as about 10 million adults in the U.S. are active users,” said corresponding author Dr. Farrah Kheradmand, a pulmonologist and professor of medicine at Baylor College of Medicine.
Some e-cigarette-related studies have reported negative effects of vaping on health, while other reports stand for the safety of the products when compared to tobacco cigarettes.
“These opposing views on the safety of e-cigarettes prompted one of my graduate students, Matthew Madison, to investigate the effects of chronic exposure to e-cigarette vapors and to conventional tobacco smoke on murine lung function,” said Kheradmand, who also holds the Nancy Chang, Ph.D. Endowed Professorship for the Biology of Inflammation Center at Baylor. “We also looked at the effect of vapors or smoke on the function of immune cells called macrophages residing within the lung. These cells represent a first line of defense against  such as those caused by influenza virus.”
The  consisted of four groups of mice. One group was exposed to e-cigarette vapors containing nicotine in the common vaping solvents propylene glycol and vegetable glycerin, in the proportions (60/40) found in e-cigarettes. A second group received vapors with only solvents but no nicotine. These groups were compared with mice exposed to tobacco smoke or to clean air.
The mice were exposed to tobacco smoke or e-cigarette vapors for four months following a regimen equivalent to that of a person starting smoking at about teenage years until their fifth decade of life. This smoking regimen markedly increases the risk of people developing emphysema, a condition in which the lungs’ air sacs are damaged causing shortness of breath.
The researchers found that, as expected, mice that were chronically exposed to cigarette smoke or to e-cigarette vapors with nicotine and solvents had severely damaged lungs and excessive inflammation resembling those in human smokers with emphysema.
Unexpectedly, Kheradmand, Madison and their colleagues found that the treatment with e-cigarette vapors made of propylene glycol and vegetable glycerin solvents only (no nicotine), which are currently considered to be safe solvents, also damaged the lungs. In this case, the researchers did not observe inflammation and emphysema; instead, they found evidence of abnormal buildup of lipids (fats) in the lungs that disrupted both normal lung structure and function.
They also found that the accumulated fat was not from the solvent, rather it was from an abnormal turnover of the protective fluid layer in the lungs. In addition, they observed abnormal accumulation of lipids within resident macrophages. When the mice were exposed to , the macrophages with abnormal lipid accumulation responded poorly to the infection.
“In summary, our experimental findings reveal that, independent of nicotine, chronic inhalation e-cigarette vapors disrupts normal murine  function and reduces the ability of resident immune cells to respond to infection, increasing the susceptibility to diseases such as influenza,” Kheradmand said. “Our experimental findings share similarities with previous multiple case reports describing the presence of lipid-laden macrophages in pulmonary fluid from people with -associated pneumonia. Our results support further investigations into the solvents used in vaping.”
Explore further
More information: Matthew C. Madison et al, Electronic cigarettes disrupt lung lipid homeostasis and innate immunity independent of nicotine, Journal of Clinical Investigation (2019). DOI: 10.1172/JCI128531
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Mallinckrodt -23% as it reportedly taps restructuring firms

Mallinckrodt (NYSE:MNK) has sunk 23.3% after hours after Bloomberg reports the company’s hired firms to explore restructuring.
The company has hired Latham & Watkins as a law firm and AlixPartners as consultants to advise on the potential costs from thousands of opioid lawsuits.
It may consider bankruptcy if the liabilities aren’t manageable, according to the report.
Also lower in the wake of the report: Teva (NYSE:TEVA) -1.4% postmarket; Endo International (NASDAQ:ENDP) -11.5%.
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IRhythm teams with Verily on solutions for atrial fibrillation management

IRhythm (NASDAQ:IRTC) will collaborate with Alphabet’s Verily to develop solutions to improve the screening, diagnosis and management of atrial fibrillation (AF) patients.
The partnership will leverage IRTC’s knowhow in AI-based arrhythmia diagnosis with Verily’s advanced health data analytics technologies.
Under the terms of the agreement, IRTC will pay Verily $5M upfront and up to $12.75M in development and regulatory milestones.
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