Month: June 2021

Drug makers struggle to revive interest in anti-obesity pills once seen as surefire hits

first_imgNewer weight loss drugs only command a small portion of the broader US obesity market, Narachi said. About 75 percent of the prescriptions doled out for weight loss are actually generic amphetamines. Orexigen’s angle, now, is to point out to doctors that these amphetamines can be addictive and only work in the short term — whereas weight loss drugs like Contrave could prove safer.“In order for us to win, to succeed, our bet is pretty simple: About 18,000 prescribers write the mass majority of obesity prescriptions, and we think they’ll respond to our message of differentiation against generics,” Narachi said.Companies are still pushing obesity treatments through their pipelines: Last year, Danish drug maker Novo Nordisk rejiggered its diabetes drug Victoza and launched an obesity drug called Saxenda. And Cambridge, Mass.-based startup Zafgen is developing an experimental medication for an obesity-related disease called Prader-Willi syndrome, persevering despite the deaths of two patients in clinical trials.But investors have largely lost interest.When Arena launched its obesity drug four years ago, the share price hovered around $10; today, it’s a buck and change. When Vivus got regulatory approval for its drug, shares peaked above $28. It’s been more than a year since it traded above $2.Novo Nordisk’s Saxenda had a strong start last year, but sales appear to be slowing for this weight loss drug as well.As for Orexigen, it’s scaling back its dreams and forging ahead.The company once had grand plans to market Contrave through the large Takeda sales team — 900 members strong. With that partnership over, Orexigen has instead beefed up its upper management, hired 15 regional sales managers, and partnered with Valeant Pharmaceuticals to sell the drug in Europe. Executives talk of bringing on 160 new sales representatives in the next few months.The company projects it’ll command about 10 percent of the US obesity market by 2018.But that market is a whole lot slimmer than investors once predicted. The pill, approved in 2014, was once projected as a shoo-in blockbuster: With more than one-third of Americans obese, the market seemed ripe for a pharmaceutical that promotes weight loss. Yet today, Orexigen, which is based here in Southern California, is on the brink of a Nasdaq delisting, with shares trading below 50 cents. Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. By Meghana Keshavan May 17, 2016 Reprints Tags FDAobesitypharmaceutical industry Related: Related: Japanese drug maker Takeda in March dropped a partnership with Orexigen to market Contrave.advertisement BusinessDrug makers struggle to revive interest in anti-obesity pills once seen as surefire hits About the Author Reprints ‘The Biggest Loser’ shows the complexity of keeping weight off SAN DIEGO — Obesity may be on the rise, but the market for fat-loss pills? Flat.And flailing.Exhibit A: the recent maneuverings of Orexigen Therapeutics, which sells a moderately effective anti-obesity drug called Contrave.advertisement [email protected] And company executives acknowledged in a recent earnings call that Contrave sales have basically flatlined, and will show only marginal growth in the coming year. (Sales for Contrave in the first quarter of this year were $13 million, up from $11.5 million for the same period in 2015.)  CEO Mike Narachi said on the call that his team has developed “a focused, creative” plan to promote the drug — in part by targeting patients who are highly motivated to lose weight — and predicted the company would turn a profit in the “near term.”But in a note to clients, RBC Capital Markets analyst Simos Simeonidis projected “zero-to-limited growth” for Orexigen and expects “the next 12 months to be very difficult ones.”Orexigen isn’t alone in its struggles.As recently as five years ago, analysts were predicting that anti-obesity drugs could ring up as much as $3 billion in sales by 2020. Companies were racing to develop next-generation medication that would boost metabolism, dampen appetite, and melt away fat.In 2012, San Diego’s Arena Pharmaceuticals launched a new weight loss drug called Belviq, and San Francisco’s Vivus introduced one called Qsymia.But physicians proved reticent to prescribe the new drugs as they hit the market, in part because of a cultural reluctance to see obesity as a disease requiring medication. Others feared a redux of the diet pill horror stories of the 1990s, imagining the new wave of obesity medications would harm more than help.“Most doctors are kind of scared to prescribe these drugs,” said Dr. Eduardo Grunvald, director of the University of California, San Diego, Weight Management Program. “That said, I don’t think we’ve done a good job on educating doctors on how to manage obesity today.”Grunvald said he’s “had great success” prescribing all of the approved weight loss meds.But the market continues to struggle. Patients who do try one of the new medications often see only modest benefits, in part because some individuals are simply wired to respond better to certain drugs than others. And cost is an issue, as many insurers still aren’t paying for weight loss pills. Meghana Keshavan Obesity rates stubborn despite federal push for healthier meals Correction: An earlier version of this story misstated sales for Contrave in 2015 and 2016. The story has been updated.  APStock @megkesh last_img read more

Valeant avoids double-digit price hikes with 9.9 percent increases

first_img By Ed Silverman Sept. 22, 2016 Reprints Kristoffer Tripplaar/Sipa via AP The drug maker, which has been widely vilified for buying older medicines and then jacking up the prices to sky-high levels, increased list prices for three eye medicines by exactly 9.9 percent, according to Wells Fargo analyst David Maris.Of course, such a price hike pales in comparison to the 525 percent and 212 percent increases Valeant took on a pair of lifesaving heart drugs on the same day the company acquired the medicines in early 2015. But given the public anger over rising costs for prescription drugs, this kind of maneuver is a convenient way to avoid unpleasant scrutiny and still goose revenue.advertisement In response to intensifying criticism over drug prices, Allergan chief executive Brent Saunders promised not to raise prices by more than single-digit percentage points. So far, no other head of a large drug maker has spoken publicly about this notion or agreed to do the same thing.Yet some companies may adopt this approach quietly — and push the envelope in the process.How so? One way is to raise prices on drugs by 9.9 percent. And this is what Valeant Pharmaceuticals did last week.advertisement Related: PharmalotValeant avoids double-digit price hikes with 9.9 percent increases Ed Silverman About the Author Reprints Bipartisan bill in Congress would require drug makers to justify, limit price hikes [email protected] To some, such legislation may, in fact, actually be interpreted as an invitation to raise prices, but keep them below the 10 percent cutoff in order to avoid government red tape. Whether this becomes a regular practice remains to be seen.The price hikes come as Joe Papa, the new Valeant chief executive, attempts to overhaul the company following pricing and accounting scandals. In the aftermath, Papa committed to end the reliance on huge price increases.Valeant also vowed last April to provide discounts to hospitals for the heart drugs, although those discounts have not yet materialized, according to a recent survey of nearly two dozen hospital systems and medical centers surveyed by Bloomberg News. The “9.9 percent increase versus an even 10 percent seems very odd and may be an attempt to stay under the radar of managed care plans and states looking out for double-digit price increases,” Maris wrote in an investor note.He noted the three eye drugs represented just $1.2 million in combined sales in the second quarter, which is a small piece of $2.4 billion in company-wide sales. But the company is under pressure to jump-start revenue, suggesting more 9.9 price hikes can be expected. “While insignificant,” Maris opined, “we believe this may be a sign of things to come.”We asked the company why it chose to raise prices by 9.9 percent and not 10 percent, but did not receive a reply.The 10 percent threshold has taken on more than symbolic weight, though.A bipartisan group of congressional lawmakers last week introduced a bill that would require drug makers to justify their pricing and provide a breakdown of their costs before raising prices on certain products by more than 10 percent. The legislation largely mimics bills that have been introduced in more than a dozen states, although only Vermont has passed such a law. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Allergan CEO promises to limit price hikes on drugs in a bid to rebuild the ‘social contract’ Related: @Pharmalot Tags Allergandrug pricesValeant Pharmaceuticalslast_img read more

Could we one day use music to diagnose disease?

first_img Please enter a valid email address. The body’s many proteins begin their lives as long strands of amino acids before folding up into the many tangles and ribbons that make them unique. The process makes for striking imagery. But, until now, it has lacked a soundtrack. Wedding the fields of biology and music, researchers in the US and UK have come up with a way to make folding proteins sing. And if it catches on, scientists might one day be able to spot the signs of disease by listening for errant voices in a microscopic choir.“I look at what researchers are doing, and I think they’re like Magellan — they’re explorers,” said Jonathan Middleton, a composer and music researcher who splits his time between Eastern Washington University and Finland’s University of Tampere. “Right now, they have visual tools for that, and my argument is: Why not also have an auditory option?”advertisement Related: National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. Privacy Policy Researchers have created musical melodies based off the structure of proteins. Bywater and Middleton By Damian Garde Oct. 20, 2016 Reprints @damiangarde Damian Garde For a complex protein like the muscle-related connectin, the numbers describing its three-dimensional shape and amino acid content would use nearly the full range of Middleton’s piano. For something simpler, like the albumin found in blood, the numbers would be fairly modal and the song more constrained. Think “Für Elise” versus “Chopsticks.”The key is whether each melody tracks with models, graphs, and charts of a protein’s measurable characteristics. Middleton and Bywater tried out their method on 38 people, showing them visualizations of proteins and asking how well the accompanying music matched up with what they saw. A significant majority reported a correlation between sight and sound, according to results published in the journal Heliyon on Thursday, convincing the researchers that they’re onto something.In the short term, the sonification software is “a wonderful teaching tool,” Bywater said, allowing students to better understand the complex world of protein folding by assigning a memorable musical motif to each shape.But over time, the researchers hope their work could help scientists identify protein mutations that might signal disease and help scientists spotlight new ways to treat it. In the coming months, Middleton and Bywater hope to put up a website that would allow users to pick any protein in the world and get an mp3 in exchange. How getting proteins to dance the ‘YMCA’ could yield new antibiotics center_img [email protected] Through a process called protein sonification, Middleton and Robert Bywater from the Francis Crick Institute have assigned musical flourishes to match a protein’s shape, depth, and amino acid content. Each measurable stat has a corresponding pitch and rhythm. Played from the top, individual proteins become unique melodies. Leave this field empty if you’re human: “I can imagine composers having a field day with this,” Bywater said. But scientists, too, will get an audible axis to add to their toolkit for assessing proteins. Alzheimer’s disease, for example, is widely believed to result from protein misfolding, which could correlate with dissonance in molecular melodies, Bywater said.And that could be of real use in research, said David Pincus, a fellow at the Whitehead Institute not involved in the project.“I think every researcher who’s been studying one particular protein always wants a new way of thinking about the protein,” said Pincus, whose lab studies protein homeostasis. “If you can just hear a sour note and immediately diagnose a mutation, that could be quite a lot better than painfully going through amino acid by amino acid.”“We use music for a lot of things,” Middleton said. “Sports, worship, the concert hall, storytelling. Why can’t we use music for our data?” About the Author Reprints Listening to a molecular melodyVolume 0%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Link EmbedCopiedLive00:0001:3501:35  Working with Bywater, Middleton created mapping system that syncs musical motifs to a protein’s unique measurements.advertisement NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. In the LabCould we one day use music to diagnose disease? Tags musicprotein foldingsciencelast_img read more

Alzheimer’s-preventing drugs may already exist — we just can’t test them

first_img Mel Evans/AP Tags dementiadrug developmentresearch Leave this field empty if you’re human: At the same time, the FDA should take a new look at the powerful evidence available in so-called real world studies, such as the Schaeffer Center-led look at statins. Troves of data in the form of electronic medical records and insurance claims now exist for drugs that have been in use for many years. The recently passed 21st Century Cures Act took a step in this direction, requiring the FDA to establish a program for evaluating real world evidence to support the approval of existing drugs for new uses. Such a program could potentially reduce the costs associated with approval for such expanded use.Alzheimer’s devastates millions of lives each year and threatens the foundations of our health care system. We should seize every opportunity to put speed bumps in its path.Julie Zissimopolous, PhD, is associate director of the Leonard D. Schaeffer Center for Health Policy & Economics and vice dean of academic affairs at the Price School of Public Policy at the University of Southern California. The search for drugs to prevent or delay Alzheimer’s disease has been a decades-long exercise in frustration, with promising candidate after promising candidate coming up short. A drug we already have on hand that’s highly effective at something else may stop Alzheimer’s — but we are nowhere close to getting it tested for that purpose and into the hands of patients.From drugs aimed at clearing away brain deposits of an Alzheimer’s-linked protein called beta-amyloid to those targeting tau, another Alzheimer’s-linked protein, or easing inflammation or blocking certain neuroreceptors, billions of dollars have been spent in search of a blockbuster therapy, with disappointing results so far.Meanwhile, many people who use cholesterol-lowering statins to fight heart disease seem to be on a slower track for developing Alzheimer’s than the rest of the population. Yet multiple hurdles make it difficult for researchers to undertake the definitive studies to determine whether and how to use these safe and inexpensive drugs to prevent Alzheimer’s.advertisement Related: First OpinionAlzheimer’s-preventing drugs may already exist — we just can’t test them By Julie Zissimopoulos Feb. 9, 2017 Reprints Privacy Policy Related: NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. Discarded arthritis drug shows early promise against Alzheimer’s About the Author Reprints Pharmaceutical companies lack the incentive to pay for expensive clinical trials to get older drugs approved for new uses. Why? Because many of them, like statins, are already off-patent, meaning they are sold at a low price.advertisement [email protected] Eli Lilly’s Alzheimer’s drug fails in late-stage trial, dashing hopes The study, which was published in the December issue of JAMA Neurology, showed that some statins may be more effective at preventing or delaying Alzheimer’s disease than others. It also suggested that the effects of statins may depend on race and gender.An important caveat: Because the study was not a randomized clinical trial, it does not provide the kind of cause-and-effect evidence about statins and Alzheimer’s disease the FDA needs to approve a new use for statins. Instead, we need randomized clinical trials to determine if statins truly do prevent or delay Alzheimer’s disease and, if so, which statin is most effective for which group(s) of patients, the optimum dosing levels, and at what age individuals need to start taking a statin to ward off Alzheimer’s.Such trials should independently clarify the preventive and therapeutic effects of statins on the risk and progression of Alzheimer’s disease. Trials that use brain imaging, for example, may help identify how statins work in the brain and whether other therapeutic treatments may be needed after the onset of disease symptoms.Some people with a family history of Alzheimer’s might be tempted to ask their doctors to prescribe a statin now on the basis of preclinical trial evidence. But that is mostly a nonstarter. Many physicians are rightly reluctant to prescribe drugs for off-label, unapproved indications, and insurance companies often refuse to cover the use of drugs for them.The National Institutes of Health, other publicly funded entities, and public and private partners should take up the cause of new clinical trials for statins. And given the stakes for both Americans’ health and the federal budget, Congress should ensure that adequate funding is available for such trials. Some trials testing whether statins could reverse Alzheimer’s failed to produce conclusive evidence. But they did not address whether taking statins decades before Alzheimer’s symptoms arise might prevent the disease. Julie Zissimopoulos Please enter a valid email address. We need to wake up to what is at stake.With the status quo, the number of Americans over age 70 with Alzheimer’s will jump from 3.6 million to 9.1 million by 2050, according to research two colleagues and I have done using what’s called the Future Elderly Model. We predicted that annual costs for treating people with Alzheimer’s will top $1.5 trillion in 2050, which would devour the Medicare and Medicaid budgets.A delay of Alzheimer’s onset by just one year would shrink the number of Americans with the disease by 1.3 million and save $219 billion annually.Researchers have suspected for some time that a high level of cholesterol in the bloodstream might be linked to the accumulation of beta-amyloid plaques in the brain, one signature of Alzheimer’s. If statins can successfully reduce cholesterol levels and prevent heart disease, so the thinking goes, they could also influence the advent and advancement of Alzheimer’s.To find out if that’s so, two other colleagues and I from the University of Southern California Schaeffer Center for Health Policy and Economics looked at the Medicare claims of 400,000 men and women who used a statin but who did not have Alzheimer’s before 2009. We followed them through 2013 to see which ones developed the disease.Women with high statin use were 15 percent less likely, and men 12 percent less likely, to have been diagnosed with Alzheimer’s each year compared to individuals with little or no use of a statin. @zissimop last_img read more

Fitbit tracks your steps; now it wants to chart your Zs, too

first_imgHealthFitbit tracks your steps; now it wants to chart your Zs, too All Fitbits will offer recommendations through the Fitbit app on ways to improve sleep. For example, if you get more sleep on weekends, Fitbit might suggest that you’re not getting enough during the week. Or if sleep quality improves after exercise, the app might suggest more workouts.Ultimately, Fitbit hopes to personalize recommendations on how much sleep you need rather than rely on general guidelines from studies, said Shelten Yuen, Fitbit’s vice president of research and development. Some might need more, others less, and Yuen said Fitbit can tell based on signs such as increased heart rate and fatigue.— Anick Jesdanun Related: NEW YORK — Fitbit, whose devices encourage people to walk 10,000 steps each day, now wants to put them to sleep as well.The company said data collected by the millions of Fitbit trackers in use show that people are averaging less than seven hours of sleep a night, the amount recommended by the Centers for Disease Control and Prevention. And the Zs people do get aren’t necessarily the right kind of sleep.So Fitbit will offer deeper sleep tracking on some of its devices. Fitbits already track how much sleep people get and use sensors to measure periods of being awake or restless while in bed. Now, using a built-in heart-rate monitor, the devices will break sleep into clinically defined stages.advertisement By Associated Press March 6, 2017 Reprints For example, about a quarter of sleep is supposed to consist of the rapid-eye movement, or REM, phase. This is when dreams occur, and scientists believe it’s important for improving memory. Fitbit says devices with this new Sleep Stages feature will be able to measure whether you get enough REM sleep.Fitbit also announced an updated version of its Alta tracker. The new version has heart rate monitoring and seven days of battery life. The Alta HR goes on sale in a few weeks for about $150. Fitbit will start taking orders on Monday. Existing Charge 2 and Blaze devices will get the sleep feature through free software updates.advertisement Mark Lennihan/AP One of Fitbit’s chief competitors, the Apple Watch, doesn’t come with sleep tracking, as it needs a nightly recharge. Other fitness trackers and smartwatches do offer sleep tracking with varying degrees of depth and accuracy, but the sleep capabilities often take a backseat to features for running, cycling and other exercise.According to research firm IDC, Fitbit is the leading seller of wearable devices, but it’s facing a steep decline because most of its sales are in the US, where many people who want a fitness tracker already have one. Pushing capabilities beyond exercise could help Fitbit appeal to people whose fitness routines are already stable.“We really want our users to think about sleep as being as important as your activity,” said Christina Kothari, senior product marketing manager at Fitbit.center_img Tags wellness Step inside a wired nursery: Lots of tech — and not much evidence it’s helpful Associated Press Fitbit likely won’t improve your health, study says Related: About the Author Reprintslast_img read more

Brain scans may change care for some people with memory loss

first_img In small Alzheimer’s study, hints of modest benefit from unusual drug Related: “We’re not accurate enough,” said Dr. Gil Rabinovici of the University of California, San Francisco, who is leading the new research.“Patients know there’s something wrong. Often they can sense in their gut that it’s not normal aging,” he added. Without a clear-cut test, “doctors are very reluctant to make the diagnosis in many cases.”advertisement Their brains had the telltale signs of Alzheimer’s. So why did they still have nimble minds? Associated Press HealthBrain scans may change care for some people with memory loss Related: More intriguing, just 54 percent of the MCI patients had amyloid build-up, putting them at higher risk for later Alzheimer’s. For the rest, “Alzheimer’s disease was effectively ruled out, so it’s something else,” Rabinovici said.The early findings don’t prove PETs affect health outcomes.But the Centers for Medicare and Medicaid Services helped plan the research and insisted on this midpoint check to be sure the study should continue, said Maria Carrillo, the Alzheimer’s Association’s chief medical officer. Researchers also will compare the 18,000 study participants with Medicare records of similar patients who didn’t get PET scans, seeking final evidence of benefit.“To get that right diagnosis, that’s really important,” said Cynthia Guzman of Napa, California, whose initial Alzheimer’s diagnosis was ruled out in an earlier PET scan study.Guzman had unusual fluctuating memory problems. Some days she functioned normally. Others, she’d stop her car at a stop sign without knowing how she got there or where she was going. Eventually, tremors and hallucinations led specialists to conclude she has Lewy body dementia. Knowing, Guzman said, has allowed her to avoid a list of common medications that could worsen her symptoms. Yet it’s not clear how best to use the new amyloid-detecting scans, which can cost up to $6,000. They can rule out Alzheimer’s if there’s little amyloid. But cognitively healthy seniors can harbor amyloid, too, and Medicare won’t pay for the new scans outside of a few research studies.One of those is the IDEAS study, which is testing the impact of amyloid-detecting PET scans in more than 18,000 Medicare beneficiaries. To enroll, patients either must have atypical dementia with an unclear cause — or have particularly puzzling “mild cognitive impairment,” or MCI, early memory problems that raise the risk of later developing dementia. Researchers check if doctors’ initially recorded treatment plans — medications, counseling or additional testing — were altered by patients’ PET results.That happened in about two-thirds of the cases, according to preliminary findings from nearly 4,000 patients who were the first to enroll.Most changes involved medications that can temporarily ease Alzheimer’s symptoms, said Rabinovici, who presented the findings at the Alzheimer’s Association International Conference in London. The PET scans found 70 percent of the dementia patients indeed had amyloid build-up, pointing out those who might benefit from those drugs and those who won’t. ‘I just want to reboot my brain’: How dementia gripped Robin Williams center_img While any treatment changes today may be modest, researchers are hunting drugs that eventually might at least slow Alzheimer’s rather than just treat symptoms, more impetus for a precise diagnosis.“We all hope for a day when this will be critically important,” said Dr. Richard Hodes, director of the National Institute on Aging, who wasn’t involved with the IDEAS study.For now, in addition to people who qualify for the IDEAS study, the Alzheimer’s Association and Society of Nuclear Medicine and Molecular Imaging say:—Unusually young dementia patients, younger than 65, also might be candidates for a PET scan.—The scans shouldn’t be used as a screening tool for people without symptoms or who worry they’re at risk.—Nor are they for people who can be diagnosed by standard means, or to determine disease severity. By Associated Press July 19, 2017 Reprints R. Scott Turner points to PET scan results that are part of a study on Alzheimer’s disease at Georgetown University Hospital. Evan Vucci/AP About the Author Reprints — Lauran Neergaard Until a few years ago, amyloid build-up could only be seen during autopsies. Older types of PET scans show what region of the brain appears most affected, of limited help. Related: WASHINGTON — Does it really take an expensive brain scan to diagnose Alzheimer’s? Not everybody needs one but new research suggests that for a surprising number of patients whose memory problems are hard to pin down, PET scans may lead to changes in treatment.The findings, reported Wednesday, mark a first peek at a huge study under way to help determine if Medicare should start paying for specialized PET scans that find a hallmark of Alzheimer’s — a sticky plaque called amyloid.Alzheimer’s is the most common form of dementia, and classic symptoms plus memory tests often are enough for a reliable diagnosis. But unusual symptoms could mark another form of dementia that, while there are no cures, could require different symptom care. And on the other end of the spectrum, it’s hard to tell if mild memory loss might be an early Alzheimer’s signal, a more treatable condition such as depression, or even age-related decline.advertisementlast_img read more

The ‘elective’ issue: Medical schools are failing to teach doctors to discuss abortion

first_imgLeave this field empty if you’re human: Recent calls to train more abortion providers are timely, but they will founder without sustained institutional support. Medical schools must immediately set formal standards for how to discuss abortion with patients and with colleagues. They must then expand the role of reproductive health experts in developing required classroom and clinical experiences around abortion. And when students’ beliefs require they have no direct role in abortion care, schools must teach them how to mitigate any resulting delays or lapses in care for their patients, and to frame their refusals in a way that does not magnify abortion stigma.Medical schools have a responsibility to ensure that future physicians appreciate the health impacts of safe and legal abortion care, regardless of political efforts to change its legality. Their future patients’ lives depend on it.Benjamin E.Y. Smith, M.D., is a faculty member at the Fort Collins Family Medicine Residency at Poudre Valley Hospital. Almost all of the students who used the term “elective” in their interviews misunderstood the difference, and used its non-medical meaning. They inappropriately juxtaposed “elective” and “medically necessary,” and used “elective” to describe abortions they considered to be sought for “social” or “convenience reasons.” The few who mentioned abortion after rape and incest were careful to clarify that those were unique social situations where abortions were not to be considered elective. In our interviews, students used “elective” to mark abortions sought for what they considered less-acceptable reasons or by what they considered less-acceptable people. Many students conveyed this bias by expressing that they would likely refuse to provide “elective” abortions in their future practice despite being willing to provide others.advertisement By Benjamin E.Y. Smith Nov. 6, 2018 Reprints About the Author Reprints First OpinionThe ‘elective’ issue: Medical schools are failing to teach doctors to discuss abortion Related: [email protected] Joe Raedle/Getty Images Not a single student questioned their non-medical use of the term, and many described this use of “elective” being reinforced by their educational environments. Some noted how teachers ignored or glossed over the topic of elective abortion; others clarified that unless students went to certain clinics on certain days, they would only be exposed to what they were told were medically necessary abortions or, more commonly, no abortions at all.One student related a story of seeing a patient transferred to an academic center from a freestanding abortion clinic for medical complications of pregnancy, but then having the patient be unable to receive care because no available faculty members would participate in an abortion that was considered elective. Benjamin E.Y. Smith Related:center_img More than 25 million unsafe abortions performed worldwide each year Categorizing any abortion as unnecessary or unacceptable, especially when couched in co-opted medical jargon, is egregiously unprofessional. It places patients at risk of inferior treatment, and is also squarely at odds with standards set by the American College of Obstetricians and Gynecologists and other specialties that provide reproductive health care. But with some medical schools providing no formal education about abortion and the majority offering a single lecture or a non-required rotation, medical students’ hazy or incorrect knowledge about abortion care should not be a surprise.In a vacuum, medical students get their knowledge from informal systems sometimes referred to as the hidden curriculum. As we describe in our report, misuse of the term “elective” exposes a hidden curriculum for abortion care that teaches students to make medically meaningless distinctions between abortions, to make inappropriate refusals of care, and to judge patients.This hidden curriculum may make abortion more difficult to access, but it could also create a generation of physicians who are unprepared to even talk with their patients about abortion. At a time when physicians should be speaking out against threats to essential health care services, our research suggests that future obstetricians and gynecologists are ill-equipped to do so. As medical schools ignore the topic, medical trainees learn incorrect information through informal means, and ultimately abortion care becomes more stigmatized and more critically threatened. Privacy Policy Safe, legal abortion is an essential part of health care. Nearly one-quarter of American women will have an abortion in their lifetimes, despite barriers such as closed clinics, lack of insurance coverage, and various forms of stigma. Providing abortion care also has its barriers, due in large part to the anti-abortion activism that distorts this basic health service. But there are hidden contributors as well, which pose more insidious risks to abortion access: Aspiring doctors are learning harmful ways of discussing abortion and their medical schools are doing little to stop it.To understand this, several colleagues and I analyzed interviews with 74 students in their final year of medical school who were planning to specialize in obstetrics and gynecology. We reported our findings in the journal Social Science & Medicine.During lengthy interviews, more than half of the students used the term “elective” to differentiate some abortions from others. This piqued our interest because “elective” has a very specific — and confusing — medical meaning. Within medicine, “elective” describes procedures that can be scheduled in the future, and differentiates them from procedures that must be performed immediately. “Elective” does not imply anything about the value or importance of the procedure; indeed, a lifesaving surgery should be called elective if it doesn’t need to be done today. Using this framework, the vast majority of abortions performed in the United States are appropriately categorized as elective.advertisement Outside of medicine, however, “elective” means voluntary or optional. Please enter a valid email address. Trump administration launches review of scientific research involving fetal tissue Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. Tags educationphysicianswomen’s healthlast_img read more

Pharmalittle: Pharma keeps winning in Washington; J&J faces test as Oklahoma opioid trial wraps up

first_img GET STARTED Pharmalittle: Pharma keeps winning in Washington; J&J faces test as Oklahoma opioid trial wraps up Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Alex Hogan/STAT Hello, everyone, and how are you today? We are doing just fine, thank you, courtesy of a shimmering sun and deliciously cool breeze wafting across the serene Pharmalot campus. An unusual quiet has, in fact, descended upon us, since one short person is sleeping in, another has left for gainful employment, and the official mascot is holding a snoozefest. This leaves us to our usual tasks of brewing cups of stimulation and keeping busy finding interesting developments. Meanwhile, here are some tidbits to help you on your own journey. Have a good one. …Lawyers for the state of Oklahoma urged a judge to find Johnson & Johnson (JNJ) culpable for the state opioid crisis and make the company pay $17.5 billion to help clean up the damage, the Washington Post writes. State and company lawyers delivered spirited closing arguments that capped the landmark seven-week proceeding — the first state trial in what has become a nationwide effort to recoup money from the drug industry for the cost of the crisis. Judge Thad Balkman is expected to issue a decision near the end of August. @Pharmalot Ed Silverman 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. [email protected] Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTEDcenter_img By Ed Silverman July 16, 2019 Reprints Log In | Learn More Pharmalot About the Author Reprints 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. What is it? What’s included? Tags cancerCongressdrug pricinggovernemnt agencieslegalopioidspharmaceuticalspharmalittleSTAT+last_img read more

Some 9/11 firefighters may have higher heart risks now

first_imgHealthSome 9/11 firefighters may have higher heart risks now Associated Press By Associated Press Sept. 6, 2019 Reprints Firefighters who arrived early or spent more time at the World Trade Center site after the 9/11 attacks seem to have a modestly higher risk of developing heart problems than those who came later or stayed less, doctors reported Friday.The research might have implications for any efforts to expand the list of health problems eligible for payment from a victim compensation fund.The study has some big limitations and can’t prove that dust or anything else about the disaster caused increased heart risks. It also doesn’t compare the New York firefighters to the general population or to other responders such as paramedics or construction workers.advertisement Mark Lennihan/AP Leave this field empty if you’re human: Judith Graber, a researcher at Rutgers School of Public Health who has studied other 9/11 responders, called the research “very well conducted” and said “the important thing is the accumulation of evidence” suggesting increased risk.Prezant said some other studies found signs suggesting a greater risk of heart problems, which are not covered now by the program that treats responders or the victim compensation fund. He said administrators will need more information to decide whether to include those conditions for any groups, such as firefighters who responded early.“This adds to the evidence but it doesn’t guarantee coverage,” Prezant said.Dr. Nieca Goldberg, a cardiologist at NYU Langone Health and an American Heart Association spokeswoman, said 9/11 responders must stay alert for possible problems.“Everyone needs to know potential symptoms of a heart attack so they can get rapid care,” she said.— Marilynn Marchione Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Tags cardiology “This is a modest increase, not an epidemic,” said one study leader, Dr. David Prezant, chief medical officer of the Fire Department of the City of New York. However, “this risk increases over time; it doesn’t disappear.”Results of the federally funded study were published in the journal JAMA Network Open. It tracked the health of 9,796 male firefighters through 2017 — 16 years after the collapse of the twin towers exposed many to a cloud of thick dust and particles from fires that burned for days. Female firefighters were excluded because there were only 25 and their heart risks may differ.Medical records were available for years before the attacks, so researchers could consider high blood pressure, cholesterol, smoking, and other factors.They documented 489 heart problems since the disaster, including 120 heart attacks and roughly 300 procedures or surgeries for clogged arteries. Risks were higher among the 1,600 firefighters who arrived at the site by noon on Sept. 11, 2001, and among the 2,400 who worked there during six months or more.There are good records on arrival times but less on duration at the site, making that result less reliable. Being counted as having worked one month could be one day during that month or 30 days.center_img Please enter a valid email address. But it does suggest that working at the site raised risk for some firefighters more than others. Those who arrived by noon that day had a 44% greater chance of suffering a heart problem in the years since the attack compared to firefighters who came hours or days later.Risk was 33% higher for those who worked there during six or more months versus less time.advertisement Privacy Policy About the Author Reprints That may sound large but heart problems were fairly uncommon — only about 5% of these firefighters developed one. Trending Now: Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson last_img read more

Swiss authorities probe Boehringer Ingelheim and other companies for antitrust practices

first_imgPharmalot 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. What is it? [email protected] A Swiss government agency that last month opened an antitrust investigation into several drug makers and distributors has now disclosed the names of nearly a dozen companies that may have fixed the market for an ingredient used to make a treatment for stomach pain.In a notice published on Tuesday, the Swiss Competition Commission identified Boehringer Ingelheim and 10 other companies or related subsidiaries that are believed to have established minimum pricing for scopolamine butylbromide, and then divided the market by regions. The treatment is marketed as Buscopan as well as other names and is also used to treat renal colic and bladder spasms. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Tags drug pricinglegalSTAT+ By Ed Silverman Oct. 31, 2019 Reprints What’s included? Ed Silvermancenter_img 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. Swiss authorities probe Boehringer Ingelheim and other companies for antitrust practices A Boehringer Ingelheim pharmaceutical factory in Ingelheim, Germany. Michael Pobst/AP Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Log In | Learn More @Pharmalot GET STARTED About the Author Reprintslast_img read more