Children with allergies, asthma may be at risk of heart problems, too

Posted On Jun 23 2021 by

first_img Children with bad allergies and asthma have a much higher risk of developing cardiovascular problems at a young age, according to research published Tuesday in the Journal of Allergy and Clinical Immunology.Allergies and asthma have already been tied to obesity and other metabolic disorders in adults. The new research suggests the conditions might be more of a public health problem than previously realized.Researchers looked at data on 13,275 children between birth and age 17 in the US and found that asthma and allergies in young children were associated with an increased risk of developing high blood pressure, high cholesterol, and obesity. In addition, eczema, a condition that causes itchy, inflamed skin, was associated with a higher risk of obesity.advertisement Related: Another factor: Children with the most severe cases of asthma and allergies are often treated with steroids. Asthma patients, for example, are often prescribed a drug that falls into the family of beta-agonists, which relax constricted airways and ease breathing. But while they relieve symptoms of asthma, Marshall said, they also can raise blood pressure.“This finding really underscores why we need safer and better long-term medications to treat these disorders,” Silverberg said.Experts said doctors and parents need to be more attuned to cardiovascular problems that crop up in children with asthma and allergies, including checking their cholesterol levels periodically. But they said not enough physicians are doing so.“It hasn’t yet risen to the conscious level of providers that deal with this on a regular basis,” Marshall said, “and that’s alarming.” Megan Thielking Unvaccinated babies not always welcome in pediatricians’ offices On the left is Dulera and on the right is Albuterol, both used for asthma. News Editor Pediatricians urge tough rules on e-cigarettes Tags allergiesasthmapediatrics “If there’s smoke in all these different places, you’ve gotta believe there’s a fire somewhere,” said Dr. Gailen Marshall, an allergy and immunology researcher from the University of Mississippi who was not affiliated with the study. “It’s just a matter of figuring out where the fire’s coming from, and that’s the stage of research we’re in now.”advertisement About the Author Reprints Alan Levine/Flickr @meggophone HealthChildren with allergies, asthma may be at risk of heart problems, too Related: By Megan Thielking Dec. 8, 2015 Reprints [email protected] One possible factor: Children with severe asthma often find it difficult to participate in sports or other physical activity. Kids with severe eczema face a similar problem, because sweat exacerbates their skin condition.These issues can lead to a sedentary lifestyle, and that, in turn, can lead to cardiovascular problems. And there’s no good research on how to keep kids moving when exercise leads to serious side effects like asthma attacks, said Dr. Jonathan Silverberg, a dermatologist at Northwestern University and the lead author of the study. But researchers aren’t sure why the link exists.last_img read more


Valeant to pay former CEO Pearson $83,000 a month for consulting

Posted On Jun 23 2021 by

first_img @Pharmalot Leave this field empty if you’re human: “His whole arrangement was pretty significantly flawed from the beginning,” said Mark Reilly, managing director of The Overture Group, a compensation consulting firm. “It’s heavily weighted toward an aggressive stock-based plan. You could make an argument that it encouraged too much risk-taking.”Last week, Valeant released a new plan for executive compensation in an effort to blunt such criticism.“As for the consulting, it’s common to see that as a goodbye for a CEO,” Reilly continued. “Is he actually going to do any consulting? Those are questions the board should ask before putting it in place. But the change in his salary for this year is almost a retroactive salary increase. Given that they did that, I’m not really sure they had to do the consulting.”After the consulting deal expires in December 2017, the arrangement can be extended in one-month increments. In addition to the consulting fees, Valeant has also agreed to provide Pearson health, medical, and dental benefits, and an office in its Madison, N.J., building for up to two years. Please enter a valid email address. Valeant price hikes will pay for generous executive retention bonuses Besides the consulting work, Pearson is also scheduled to receive a $9 million severance payment within 60 days of his May 2 departure. Although he did not receive a salary last year and his bonus was reduced to $2 million, Pearson is being paid a $2 million annual salary for 2016, which means he can expect to receive about $700,000, according to a recently filed proxy statement (see page 49).Pearson also holds long-term deferred-stock awards that were valued at $140 million when they were granted. However, these only convert to Valeant shares if the stock achieves big gains by 2019 and 2020 over the base price of more than $140 a share when they were awarded. Recently, Valeant stock has been trading slightly above $28 a share.advertisement By Ed Silverman May 31, 2016 Reprints Privacy Policy How much is one month of advice from Michael Pearson worth? Valeant Pharmaceuticals is willing to pay more than $83,000.Valeant stock may have tanked and its growth strategy imploded during his final months running the beleaguered drug maker, but Pearson was just awarded a consulting contract that will pay him more than $583,000 through the end of this year and as much as $180,000 next year, or $15,000 a month, according to a filing with the US Securities and Exchange Commission. The fees will be pro-rated for partial months.The consulting services were listed in a letter that outlines his separation agreement, which was dated May 26, more than three weeks after his tenure as Valeant chief executive ended. He has since been replaced by former Perrigo Chief Executive Joe Papa.advertisement PharmalotValeant to pay former CEO Pearson $83,000 a month for consulting Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry.center_img Ed Silverman Tags executive payMichael PearsonValeant Pharmaceuticals [email protected] Newsletters Sign up for Pharmalot Your daily update on the drug industry. Former Valeant CEO Michael Pearson Canadian Press/Ryan Remiorz Related: To what extent the consulting fees may ignite protest is unclear. For now, the consulting contract pays less than $1 million, which is unlikely to grab the attention of most investors for more than a moment. But much like the $10.8 million in retention bonuses to be handed out to three executives by the end of this year, the funds were generated by a tactic that hinged on buying drugs and then jacking up prices by sky-high amounts.That approach made Valeant a Wall Street favorite thanks to the loans used to buy companies and medicines, and the resulting fast-paced revenue that fueled a rising stock price. Pearson famously espoused a view that R&D was an expensive and, therefore, unnecessary pursuit, a philosophy that suggested he was at the forefront of a new business model for much of the pharmaceutical industry.But his pronouncements later amounted to hubris as the maneuvering came crashing down last year amid consumer outrage and congressional scrutiny. There were also questions about accounting practices and clandestine dealings with a mail-order pharmacy. Papa has now inherited a company facing multiple federal and state investigations into pricing and accounting, among other issues.While some patients and, more recently, investors have not benefited, Pearson is faring better, although his compensation package has been criticized. About the Author Reprintslast_img read more


Norovirus outbreak confirmed among Republican convention staffers

Posted On Jun 23 2021 by

first_img Matt Rourke/AP By Sheila Kaplan July 20, 2016 Reprints Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. HealthNorovirus outbreak confirmed among Republican convention staffers Health officials are now taking food histories from those who had fallen ill — and are staying at a resort hotel about an hour outside of Cleveland — to try to pinpoint the cause.“We’re asking, ‘What did you guys do? Did you do anything together before you came out?”’ Schade said.advertisement Public health authorities said Wednesday that testing has confirmed that about a dozen Republican convention staffers in Ohio had been struck by norovirus.Peter Schade, the Erie County health commissioner, said he met Wednesday morning with members of the group, who were part of the advance team for California’s delegation to the convention. Schade said investigators do not yet know how the staffers contracted the severe gastrointestinal bug, but they believe the chain of transmission started in California.“It came with them,” Schade said.advertisement Privacy Policy Please enter a valid email address.center_img A serious stomach bug: Norovirus costs billions of dollars of lost productivity Related: Jim Brulte, chairman of the California delegation, told STAT in an email Tuesday that the outbreak began when one of the staffers came down with a virus and infected her husband.Since it has been 36 hours since the last new case, Schade said, he is optimistic that the bug has been contained. Noroviruses cause violent bursts of vomiting and diarrhea. It’s highly contagious, and those who contract it typically experience symptoms for only one to three days; most people recover without medical care. Some victims, however, especially young children or the elderly, require treatment for dehydration.The Centers for Disease Control and Prevention says that noroviruses are the leading cause of illness and outbreaks from contaminated food in the US. Leave this field empty if you’re human: Tags noroviruspolicyviruseslast_img read more


New tools for assessing drug value haven’t caught on with payers — yet

Posted On Jun 23 2021 by

first_img Ed Silverman Each of the four groups is seeking to fill an information void by providing ways for payers to evaluate new prescription drugs. Over the past two years, they have either released or begun developing tools that payers and physicians — and in some cases, patients — can use to assess value. These are still early days, of course, but one of the groups has met with some controversy.Notably, ICER has been criticized by the pharmaceutical industry for its methodology. Last spring, Amgen openly challenged the nonprofit’s review of bone cancer drugs. In a nod to the criticism, the group two weeks ago openly began soliciting suggestions for ways to improve its approach. The survey found that 64 percent do not plan to rely on ICER next year. PharmalotNew tools for assessing drug value haven’t caught on with payers — yet But she said the new tools are filling a void by comparing the value of existing medicines with new ones coming to the market to gauge cost effectiveness. However, she pointed out the ASCO and NCCN tools differ slightly from the others by orienting the assessment toward physicians and patients. In fact, 82 percent of plans do not expect to use the ASCO tool next year compared with 64 percent for NCCN.In a statement, ASCO chief medical officer Dr. Richard Schilsky noted the organization has revised its tool and is currently in the process of updating software to provide information more quickly to doctors and patients. We also asked NCCN for comment and will update you accordingly. APStock For now, Seidman explained that the plans would like to see physicians and other health care providers more readily embrace the value tools before formally incorporating them into any decision-making procedures. The health plans, by the way, sell coverage across various markets — commercial, Medicare, Medicaid, and the health care exchanges. And the survey was conducted over the past several weeks. [email protected] Pricey drugs overwhelm Medicare safeguard The results come as payers — both public and private — grapple with rising costs for medicines, as well as increasingly higher price tags for newly launched treatments. The pharmaceutical industry has argued that rebates and discounts lower costs, but these numbers are never released. Meanwhile, payers are moving to tighten coverage when a lack of competitive medicines reduces their bargaining power.advertisement Newsletters Sign up for Pharmalot Your daily update on the drug industry. Tags AmgenASCOdrug prices By Ed Silverman July 26, 2016 Reprintscenter_img Leave this field empty if you’re human: But Dr. Steve Pearson, who heads ICER, wrote us that he is aware of some payers that are already using “elements of our work. Both the clinical effectiveness and the cost effectiveness results are being used both as input when they make their own coverage decisions and when they enter into negotiations” with drug companies.Meanwhile, Dr. Peter Bach, who helped develop the Abacus tool at Memorial Sloan Kettering, told us that he was not discouraged by the survey results, despite findings that 64 percent of the plans do not expect to rely on his Abacus next year, while 27 percent may use the tool and another 9 percent reported that they are very likely to do so.“I think this constitutes substantive progress. It’s only been 13 months since we launched. I’m buoyed by seeing the interest,” said Bach, who heads the Center for Health Policy and Outcomes at the cancer center. “I think it’s going to take a while for payers to get used to the idea of paying drugs based on benefit, because it’s a different way of thinking about allocating drug spending.”A spokeswoman for America’s Health Insurance Plans, an industry trade group, said that health plans already use value tools to assess new medicines. “These are more focused on identifying and implementing specific benchmarks and protocols for measuring medication adherence and health outcomes,” she told us. Privacy Policy @Pharmalot Related: About the Author Reprints Please enter a valid email address. Related: Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. As prices for prescription drugs keep rising, several organizations have developed different ways to assess the value of new medicines based on such attributes as cost, quality of life, and effectiveness. But a new survey finds that even as health plans continue to criticize drug prices, they have not yet embraced these new tools.None of the 11 plans queried actively rely on these new methods and a majority do not expect to do so next year either, according to the survey conducted by Avalere Health and released today. The tools are being developed by four groups — the American Society of Clinical Oncology, the Institute for Clinical and Economic Review, the National Comprehensive Cancer Network and Memorial Sloan Kettering Cancer Center.The plans are “anxious to get better comparative information on the value of different therapies, but are also concerned these tools are somewhat nascent and not robust enough,” said Josh Seidman, an Avalere vice president. He noted that most respondents work as either medical director or pharmacy directors, and all but one serves on a committee that recommends prescription drug coverage. The plans cover about 37 million people, by the way.advertisement This nonprofit is playing a valuable role in framing the drug price discussion last_img read more


The compulsion to go online isn’t an illness. In fact, it shows how the mind works

Posted On Jun 23 2021 by

first_img About the Author Reprints Related: It was not psychiatry’s finest hour. Just over 20 years ago a psychotherapist claimed he had discovered a new mental illness, which he named Internet Abuse Disorder. He saw it all around him: people compulsively reading websites and sending email and feeling anxious if they couldn’t. Psychiatrists and laypeople alike flocked to a listserv to share their experience with this supposed affliction, and the American Psychiatric Association appointed a task force to explore whether there was sufficient evidence to support recognizing internet “abuse” as a mental disorder.Verdict: There wasn’t then and there isn’t now. Spending hours each day online via either mobile devices or the stationary kind is not a mental illness. In fact, the original proposal, by the late Dr. Ivan Goldberg, was meant as a joke.More than any other behavior that people engage in compulsively, the digital version — from checking Facebook to texting — shows that just because you’re compulsive about something doesn’t mean you have a broken brain. To the contrary. As with other compulsions that fall well short of pathology, the allure of being online sheds light on some of the mind’s most salient, and utterly normal, operations, according to the latest research. From our desire to connect to the way we respond to unpredictable rewards, our minds are wired in a way that lets digital technology sink its hooks into us.advertisement Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. First, a definition. A compulsive behavior is one that is repeated and chronic, and arises from a feeling of anxiety. Just as someone with obsessive-compulsive disorder (OCD) compulsively and repeatedly washes her hands, for instance, to alleviate the anxiety that comes from believing she is covered with germs, so mentally healthy people who behave compulsively are also driven by anxiety. (Checking one’s phone repeatedly is not considered a disorder, however, because the behavior is grounded in reality, not a delusion, and it usually doesn’t get in the way of living a normal life.)Often, said Moez Limayem, of the University of South Florida, who led a 2015 study on mobile use, “The underlying motivation to use a mobile phone is not pleasure,” but is instead “a response to heightened stress and anxiety.”advertisement Leave this field empty if you’re human: That fits with studies finding that people text as a way to escape anxiety; something like 70 percent of study participants say smartphones and texting help them overcome anxiety and other negative moods. It’s become a stereotype that people in awkward (read: anxiety-provoking) situations “turn to their mobile phones as a way to disengage,” the Illinois researchers wrote, especially “during times of more intense distress.”Lleras and a colleague gave volunteers a short writing assignment that, they explained (falsely), would be evaluated by two experts. To ratchet up the stress further, the researchers said the experts would also interview them about their essay. While waiting for that, half the volunteers had access to their mobile phones and half didn’t. Among those who were able to text and surf to their anxiety-ridden-heart’s content, half felt intense anxiety. In comparison, three-quarters of those who were deprived of their phones did, the researchers reported.By giving in to a compulsion to use their phone, many of the study volunteers were able to defuse much of their anxiety. “People seem to be less vulnerable to becoming stressed in anxiety-provoking situations when they have access” to their mobile phone, the researchers wrote.It’s not only being deprived of those variable-interval rewards that makes ditching their smartphone unthinkable for many people. Because it has become our main connection to other people and the world at large, the anxiety that comes from not being able to check it arises, too, from the feeling of missing something, as if everyone else is plugged in, connected, on top of things, and you aren’t.“There are people who feel, if I’m not there, if I’m not on that site, I’m missing something — something about my friends, or my health, or anything else,” said psychiatrist Dr. David Reiss, who practices in San Diego.The internet exploits this FOMO, or fear of missing out. Being disconnected is synonymous with missing out.By making us feel we are always connected to the world, smartphones also alleviate the anxiety that otherwise floods into us from feeling alone and untethered. A character in the 2014 New York City production of Laura Eason’s play “Sex with Strangers,” learning there’s no cellphone service at a bed-and-breakfast, says, “People will think I’m dead.” People don’t like feeling dead. Pediatricians relax guidelines on screen time for kids to give more flexibility HealthThe compulsion to go online isn’t an illness. In fact, it shows how the mind works Related: Please enter a valid email address. Start with the fact that many of us feel anxious if we’re not making use of every tiny slice of time. The effort required for a single online “transaction” — a click, a view, checking Instagram or Facebook — is minuscule, so much so that not texting or reading your smartphone screen feels like a greater burden than doing so. “The timescale on which you work with online technology is central to making it compelling,” said psychologist Tom Stafford of the University of Sheffield in England. “What else can you do in five seconds that’s interesting? Why not check your phone?” This is a large part of why “using the internet can be compulsive,” he said.One reason we often feel anxious if we’re not using every tiny slice of time is that we find it hard — even unpleasant and anxiety-producing — to be alone with our thoughts, as a 2014 study showed. Researchers led by social psychologist Timothy Wilson of the University of Virginia gave volunteers two options: do “nothing” for 15 minutes or give themselves a small electric shock (which three-quarters had previously told the researchers they’d pay money not to experience). Two-thirds of the men and one-quarter of the women chose the latter, so anxious were they for “something to do.”“The untutored mind does not like to be alone with itself,” Wilson concluded.Especially when the mind encounters payoffs structured like a slot machine’s. Like those one-armed bandits, the digital world offers what are called intermittent/variable rewards: An action — pulling the slot machine’s arm, checking for texts — can bring either a payoff or nothing. Most of what fills your Twitter feed or Facebook updates is digital dross. (“Barbara changed her Facebook picture!”) Payoff: zero. But every so often, you find a gem — a friend offering Bruce Springsteen tickets, an acquaintance posting a link to the morning’s must-read Trump story.“If I give you a treat sometimes, you have to keep checking all the time: You don’t know when it will come,” said Stafford. “No matter how frequently you check, even if you checked only a second ago, a brilliant email might have just come in. You feel anxiety about possibly missing something.” Such low-cost, occasionally high-reward activities are catnip to the brain.If we’re prevented from compulsively checking for texts, the anxiety that the compulsive behavior alleviates comes roaring back. Psychologists have found that people who are separated from their smartphone experience an elevated heart rate and other signs of anxiety.In one 2016 study, volunteers who filled out a standard questionnaire about their smartphone use and emotions told researchers that they turn to their phones “to avoid negative experiences or feelings” and “to cope [with] or escape from feelings related to an anxiety-inducing situation.” Psychologist Alejandro Lleras, of the University of Illinois at Urbana-Champaign, who led the study, described it as a security-blanket effect, absorbing our bubbling-over anxiety. Privacy Policy @sxbegle Psychotherapy by emoji: Mental health community wrestles with texting A 2010 study by the International Center for Media and the Public Agenda at the University of Maryland showed how profound an existential dread engulfs people cut off from the online world. The researchers asked 200 students to abstain from using their phones and computers (and all other media) for 24 hours. Describing their experience, the students said they felt disconnected and anxious that they were missing out on something, using terms evoking compulsion: Frantically craving. Very anxious. Extremely antsy. Miserable. Jittery. Crazy.It’s worth reading some of their comments:“Texting and IM’ing my friends gives me a constant feeling of comfort … the fact that I was not able to communicate with anyone via technology was almost unbearable.”“I feel so disconnected from all the people who I think are calling me, but really they aren’t half the time.”“I couldn’t take it anymore being in my room … alone … with nothing to occupy my mind so I gave up.”And if we do miss out? If we’re not connected? If existence is defined these days by an online presence, then not being online is not to exist. Human history knows no greater motivation for action than the existential one of raging against the dying of the light. When we are not online, when we are not connected, when we miss out, we do not exist, and that causes the most unbearable and existential anxiety there is.That is how we should understand the digital compulsion: not as a pathology, but as the result of the online world’s ability to tap into something deep in the human psyche and make many of us digital casualties.This article has been adapted from Sharon Begley’s book “Can’t. Just. Stop.: An Investigation of Compulsions,” published by Simon & Schuster on Feb. 7. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. By Sharon Begley Feb. 8, 2017 Reprints Alex Hogan/STAT Tags mental health Sharon Begley [email protected] last_img read more


Up and down the ladder: The latest comings and goings

Posted On Jun 23 2021 by

first_imgPharmalot About the Author Reprints [email protected] Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Up and down the ladder: The latest comings and goings What’s included? Log In | Learn More Alex Hogan/STAT STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. @Pharmalot center_img What is it? GET STARTED Hired someone new and exciting? Promoting a rising star? Finally solved that hard-to-fill spot?Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED By Ed Silverman Jan. 26, 2018 Reprints Ed Silverman Tags pharmaceuticalsrecruitingSTAT+last_img read more


Amgen is probed by Danish regulator after employee posts press release on LinkedIn

Posted On Jun 23 2021 by

first_img Log In | Learn More STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Alex Hogan/STAT Amgen is probed by Danish regulator after employee posts press release on LinkedIn Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Ed Silverman Pharmalot GET STARTED What’s included?center_img About the Author Reprints @Pharmalot Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. By Ed Silverman Feb. 9, 2018 Reprints Tags legalpharmaceuticalspolicySTAT+ [email protected] Anyone who likes to post information about drugs on social media might want to read this: The Danish Medicines Agency is investigating whether an Amgen (AMGN) employee in Denmark violated advertising laws by sharing and liking a U.S. press release about the Kyprolis medication on LinkedIn. If the law was broken, the company may have to pay a penalty and the employee could face up to four months in jail.An agency spokesman declined to provide further details, but explained that advertising prescription medicines to the general public is prohibited. Under Danish law, the general public is defined as anyone who is not a doctor, dentist, veterinarian, pharmacist, nurse, midwife, bioanalyst, clinical dietitian, radiographer, or student in one of these fields. What is it?last_img read more


Advisory firms back proposals requiring AmerisourceBergen to manage opioid risks

Posted On Jun 23 2021 by

first_img GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More Tags opioidspharmaceuticalsSTAT+ Two major shareholder advisory firms are recommending that AmerisourceBergen (ABC) stockholders support a proposal to require the pharmaceutical wholesaler to report the steps being taken to manage financial and reputational risks associated with the opioid crisis.The firms — Glass Lewis and Institutional Shareholder Services — also recommend shareholders back a proposal to disclose if its board claws back compensation from senior executives due to misconduct and another to split the chief executive and chairman jobs, a move that corporate governance experts often endorse as sound practice. The wholesaler holds its annual shareholder meeting on March 1. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What’s included? Advisory firms back proposals requiring AmerisourceBergen to manage opioid risks By Ed Silverman Feb. 14, 2018 Reprintscenter_img ed.si[email protected] What is it? About the Author Reprints Ed Silverman APStock Pharmalot @Pharmalot Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTEDlast_img read more


‘Deep medicine’ will help everyone, especially people like me with a rare disease

Posted On Jun 23 2021 by

first_img Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. It took 25 years for me to be diagnosed with common variable immune deficiency. During that quarter-century I was constantly sick — pneumonia, chest infections, urinary tract infections, several episodes of the flu each season, conjunctivitis, bronchitis, skin infections, wounds that refused to heal, and lots in between. I was hospitalized on more occasions than I care to remember. During some years, I was on antibiotics more often than I wasn’t. Yoni Maisel First Opinion‘Deep medicine’ will help everyone, especially people like me with a rare disease Privacy Policy By Yoni Maisel April 26, 2019 Reprints Paging Dr. Topol: Grasping the multidimensional narrative of ‘Deep Medicine’ I did the same thing in 2012, when I was determined to learn the reasons for the appearance of mysterious symptoms like blistering rashes, skin lesions, fatigue, joint pain, and fever. This time I discovered I had a second rare disorder, Sweet’s syndrome, a diagnosis later confirmed by expertsIn “Deep Medicine,” Eric Topol paints a picture of medicine’s “deep and intelligent” infancy and what both he and I believe to be its bright future: one filled with artificial intelligence, machine learning, deep learning, and algorithms. A present and a future in which technology is programmed and tasked with connecting elusive “dots,” dots that might never be connected by humans alone but that can be connected by humans working with algorithms.Neither of us is knocking people power. But with the vast amount of existing medical data and the explosion of new data, deep medicine promises to put humans in charge, augmented by smart machines. Nowhere in medicine is this more needed than in the rare disease sector, a space filled with as many as 7,000 distinct diseases with names such as 17-beta hydroxysteroid dehydrogenase 3 deficiency, Foix-Chavany-Marie syndrome, and molybdenum cofactor deficiency. And on a personal level, nowhere is it more applicable and relevant than for the primary immunodeficiencies, a family of 350 rare disorders.The Frontiers in Pediatrics paper I referred to at the outset is a Topol-esque manifestation of deep medicine brought to early fruition in a collaboration between Baylor College of Medicine, Texas Children’s Hospital, and the Jeffrey Modell Foundation, one of the leading primary immunodeficiency organizations. Using a massive database containing the de-identified medical records of 185,892 patients — it’s safe to assume statistically that individuals with some of the various primary immunodeficiency disorders, from common variable immune deficiency to severe combined immunodeficiency (the so-called bubble boy disease), Wiskott-Aldrich syndrome, and beyond would be among them — the researchers devised a “risk vital sign” for these disorders.From physical symptoms during checkups to pharmacy purchases, lab results, and sick days, what emerged is an alarm for the early diagnosis and subsequent management of primary immunodeficiency disorders. The algorithm provides a warning bell, a loud, ear-piercing, difficult-to-ignore klaxon that can scream out, “Check the patient for primary immunodeficiency!” Related: Despondent at the lack of answers, and beginning to believe what others were so fond of telling me — “A lot of it is just in your head” and “Quit whining, everybody gets sick sometimes” — I decided in 2007 to try to diagnose myself.During the span of a week, fueled by coffee and the midnight oil, I methodically immersed myself in the medical literature. Credit card in hand, I subscribed to the first of the medical journals I now daily peruse. I became a de facto physician, specifically an immunologist. Having completed my research, I scheduled a follow-up appointment with my general practitioner. “I know what is ailing me,” I told him. “Please draw my blood and send it for a total immunoglobulin count. And please test me for antibody titers; I recommend pneumococcal and tetanus.”His look was priceless, both astonished and amazed that I, a patient without an iota of medical training, had done such in-depth sleuthing. Yet he agreed with my request. The lab tests came back within a week and with them the makings of the diagnosis of a disease that affects somewhere between 1 in 25,000 individuals and 1 in 50,000 individuals worldwide. A diagnosis for common variable immune deficiency is so elusive that it takes three times longer than the three to seven years it takes to diagnose other rare diseases.My official diagnosis was confirmed by an immunologist and hematologist about a week later. It’s both an “intelligent” and a “deep medicine” approach to an existing medical problem. Delays in diagnosis of primary immunodeficiency disorders can have extremely detrimental effects on health. They can also be deadly. And with physicians’ enormous caseloads and mere minutes allotted to the average patient visit, the odds are heavily stacked against an elusive diagnosis for patients like me.I’m not the poster child for the kind of person who is likely to appreciate and glean meaning from “Deep Medicine.” The highlight of my math grades from high school to academia was a lone “C.” My technical acumen is almost nonexistent: Out of frustration, I dropped out of the only computer course I ever registered for. And as someone prone to beginning online IQ tests, I give up and log out each and every time I encounter the first question showing a spread-out pattern with a question asking, “What 3-D shape would appear if the pattern was folded together?”Topol’s work is readable and understandable — if I can grasp the details, intricacies, and technical “dives,” anyone can. It is also applicable. About 1 in 5 people will be diagnosed with cancer over their lifetimes, some of them rare and diagnostically elusive. One in 10 will be diagnosed with a rare disorder.In a deep medicine approach, smart machines and algorithms will help clinicians do what has, until now, been elusive and difficult due to its complexity and scale: assemble, analyze, and make sense of an enormous jigsaw puzzle consisting of an unfathomable number of pieces, including trillions of cells, thousands of genes, bodily systems and organs, axons, dendrites, genotypes, phenotypes, symptoms, and more. Elusive diagnoses, never-before-documented diseases, and the data needed for new treatments and cures will likely emerge.The concept of deep medicine should represent hope and a source of profound optimism for patients, family members, physicians, geneticists, statisticians, bioinformaticians, and others. Rather than a dark Terminator-like present and future in which fictional dark forces of AI, machine learning, deep learning, and algorithms menacingly promise “I’ll be back,” in ‘”Deep Medicine” they promise “I’ll be here.” Here to bring answers. Here to assist and enhance the medical establishment. Here to cooperate, collaborate, and augment. Here to seek, find, and create answers. Here not to replace doctors but to work with them and free them up to carry out what can and should be the apex of their professional mission: human and humanistic interactions and relationships with those in their care.Yoni Maisel is a rare disease and primary immunodeficiency patient, advocate, activist, and consultant based in Jerusalem. He writes about genetic medicine at Mutation Watch.center_img Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson About the Author Reprints Trending Now: @Primary_Immune Adobe Two things I read recently gave me hope for the future of medicine and the future of people like me with rare or difficult-to-diagnose diseases.One was the article “Calculation of a Primary Immunodeficiency ‘Risk Vital Sign’ via Population-Wide Analysis of Claims Data to Aid in Clinical Decision Support” in the journal Frontiers in Pediatrics. Not a sexy title, I know, but stick with me here. The other was Eric Topol’s newest book, “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again.”These two related works resonated with me because I have a rare disease called common variable immune deficiency. In this mostly genetic disorder, protective antibodies are either seriously lacking or entirely absent, leaving individuals susceptible to all types of infections, many of which have the potential to become life-threatening. This dearth of antibodies also leads to astronomical rates of cancer: Lymphoma is 10 times more common and gastric cancer 30 times more common in people with common variable immune deficiency.advertisement Please enter a valid email address. Leave this field empty if you’re human: During that time I was seen by a myriad of physicians, first as a “too-often-sick” child and adolescent at my mother’s behest, and later on my own as a chronically ill adult — easily dozens of different clinicians spanning the medical diagnostic spectrum. They offered a variety of diagnoses, but none that rang true.advertisement Tags Artificial IntelligenceHealth ITrare diseaselast_img read more


STAT-Harris Poll: 1 in 4 Americans were unable to get a Covid-19 test when they wanted one

Posted On Jun 23 2021 by

first_img The new poll found that 10% of Americans couldn’t get a Covid-19 test because of the long wait. TIMOTHY A. CLARY/AFP via Getty Images By Ed Silverman Feb. 15, 2021 Reprints Leave this field empty if you’re human: “This has been a bedeviling problem in the U.S. from the get-go,” said Paul Sax, clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School. “But it’s amazing that it’s still so difficult for some people to get tested. And it’s frustrating.”advertisement About the Author Reprints Ed Silverman Privacy Policy @Pharmalot In fact, the rate at which Covid-19 testing is occurring across the U.S. is spotty, at best. As of last Friday, the number of tests had increased from the previous week in 11 states, but declined in 26 states and Washington, D.C., according to the Johns Hopkins University Coronavirus Resource Center. The testing rate was unchanged for the remaining 14 states.Have you been unable to get tested for Covid-19 when you wanted to? (Select allthat apply)010203040Unable to get tested (total)Unable, no test site near meUnable, wait was too longUnable, didn’t have transportationUnable, didn’t know where to goAble to get tested when wantedHave never wanted testPercentCategoryPercentUnable to get tested (total)24Unable, no test site near me8Unable, wait was too long10Unable, didn’t have transportation7Unable, didn’t know where to go8Able to get tested when wanted31Have never wanted test45that apply)The problem dates back to the early days of the pandemic, when the Trump administration stumbled in developing and rolling out testing for the new virus. The biggest problem was an insufficient number of tests, as well as different types of tests of varying reliability. For months, people had to wait in long lines for tests, and then often wait up to a week for results.The location of testing sites was another concern, contributing to inequities in how the pandemic affected people of color. A research letter published last week in JAMA Network, for example, found that “despite programs to promote equity and enhance epidemic control in socioeconomically vulnerable communities, testing resources across Massachusetts have been disproportionately allocated to more affluent communities.”The poll also found that 49% of Americans have been tested for Covid-19: 19% once; 16% two to four times; and the rest five or more times. Most — 56% — have been tested at a hospital or drive-through site. For the vast majority, or 69%, the test was conducted using a nasal swab.The most common reason respondents cited for getting tested — at 28% — was that they had come in contact with someone who had tested positive for Covid-19, while 24% said they had possible symptoms of Covid-19 and 21% were required to get tested by their job or school.Why did you get tested for Covid-19? (Select all that apply)010203040In contact with someonewho tested positiveHad possible symptomsHad to for work orschoolVisiting at-risk personAttending gatheringNo specific reasonNone of the abovePercentCategoryPercentIn contact with someone who tested positive28Had possible symptoms24Had to for work or school21Visiting at-risk person19Attending gathering15No specific reason17None of the above16Why did you get tested for Covid-19? (Select all that apply)Meanwhile, 31% of those tested reported that they received a false positive result, which means they tested positive on an initial Covid-19 test but a retest came back negative. And 24% said they had a false negative test, indicating they tested negative initially but a retest came back positive.Many more people of color than white respondents reported false-positive and false-negative results. One possible explanation is the survey found that Black and Hispanic people were more likely to have been tested 10 or more times, since many have front-line jobs that put them in contact with the public. And those who get tested more often are more likely to get a false result, explained Rob Jekielek, managing director at The Harris Poll.Also of note: By a 2-to-1 margin, or 41% compared with 20%, respondents believe vaccination, rather than improved testing, is more important for society to return to something resembling normal.There is an interesting wrinkle, though, with 45% of white respondents looking mostly to vaccination for a return to normal, while only 32% of Black people feel similarly. Looked at another way, 29% of Black respondents indicated they feel that testing is more likely to return society to normal, while just 17% of white people share that view.“A lot of this has to do with what’s called vaccine hesitancy,” explained Jekielek. “It has to do with history in that community [of being mistreated by the health care establishment]. And so they have the lowest level of confidence in vaccines and the highest level of confidence in the value of testing.”That hesitancy was highlighted by the poll’s finding that, while interest in being vaccinated has rebounded sharply since the fall, it hasn’t done so as much among Black respondents. Overall, 69% of Americans in the latest poll said they would get a vaccine as so0n as one become available, up from 58% in October and the same as last August. The results track closely for white people, with 71% reporting they would seek a vaccine, up from 59% in October and 70% last August. But among Black respondents, just 56% now said they would get a vaccine as soon as one became available, up from 43% in October but still below the 65% recorded in August.The poll was weighted based on Census data to the general U.S. adult population. In describing the methodology, the Harris Poll said it adheres to guidelines of the American Association for Public Opinion Research: “Per AAPOR guidelines, we don’t report on a ‘margin of error’ as online surveys are not based on probability samples. For subgroup differences (such as between white Americans vs. Black/African Americans), we conduct statistical significance testing using a Student’s t-test at the 95% confidence level.” The notable percentage of people who ran into difficulties getting tested underscores one of the ongoing challenges that federal and state officials face as the country attempts to contain the coronavirus.center_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Please enter a valid email address. ExclusiveSTAT-Harris Poll: 1 in 4 Americans were unable to get a Covid-19 test when they wanted one [email protected] As the U.S. struggles to contain the Covid-19 pandemic, nearly a quarter of Americans say they wanted to get tested for the coronavirus but were unable to do so, according to the latest survey from STAT and The Harris Poll.Specifically, 24% reported that they could not get tested for various reasons – a testing site was not nearby, the wait for a test was too long, transportation to a test site was unavailable, or it was unclear where to go for a test. Some people cited more than one of these hurdles. The issue cited most often — 10% complained of the wait.At the same time, 31% said they were able to get tested when they sought to do so, according to the online survey, which queried 2,043 people between Feb. 5 and Feb. 7. The rest said they have never wanted to be tested.advertisement Tags Coronaviruspublic healthlast_img read more