Month: June 2021

first_img @Pharmalot By Ed Silverman Jan. 6, 2016 Reprints The decline may reflect the FDA’s “unfinished work” in formulating guidelines for digital media, according to Mark Senak of the public relations firm Fleishman-Hillard, who writes Eye on FDA. This is an ongoing issue that has flummoxed drug makers, who are grappling with ways to harness social media to reach consumers while trying to avoid regulatory infractions.Indeed, although drug makers have embraced the Internet — at least, in varying degrees — the FDA has been slow to issue guidelines that might prompt the agency to uncover violations that warrant letters. The agency did issue guidelines in June 2014, but these mostly provided a framework for correcting misinformation on websites run by others, while another discussed how Twitter should be used.advertisement Actavis received an infraction letter from the FDA last year for the way it promoted a drug. Richard Drew/AP Ed Silverman PharmalotFDA issues all-time low number of violation letters for drug promotions Even as the pharmaceutical industry continually advertises its medicines, the Food and Drug Administration office that monitors promotions has been issuing fewer and fewer infraction letters to drug makers. And last year amounted to a new all-time low — only nine letters were issued.Moreover, a trend may be shaping up. The combined number of letters issued over the past two years amounted to just 20, which was well below the number of letters sent each year between 2009 and 2013, according to the Eye on FDA blog, which tracks agency oversight of pharmaceutical marketing.Over the past decade, the FDA Office of Prescription Drug Promotion generally sent recalcitrant drug makers between 20 and 30 letters each year, although it reached a high of 52 in 2010. But the agency issued more than 100 letters each year between 1997 and 1999. In 1998, 156 were issued, which was right after the FDA expanded the scope of direct-to-consumer advertising. advertisement “Not only are there many gaps, but the [FDA] guidance documents that have been issued raise almost as many questions as they answered,” writes Senak. “Meanwhile, digital media continues to rapidly evolve, bringing new questions into the marketplace.”Most of the violations cited in the letters, by the way, were issued because a promotion lacked or minimized risk information, followed by companies that made unsubstantiated claims.So what does FDA say?An agency spokeswoman writes us that the OPDP “uses a risk-based approach to carefully allocate its resources … to have the greatest beneficial public health impact.” Those resources, she explains, are directed toward policy and guidance development; reviewing product labels and launches, including TV ads; enforcement; and training and communications.“It is apparent that that one cannot get a complete picture of OPDP’s program area by looking at a snapshot of time for enforcement letters.  Reviewing the number of compliance actions that OPDP takes within a year time frame does not take into account the work that OPDP does on the other priorities to assist companies with compliance.”One other point worth noting — Eye on FDA writes that, for the past few years, most of the OPDP violation letters “largely involved” drug makers that are “lesser known” and typically have fewer products on the market. Are smaller drug makers bigger risk takers when it comes to promotions? Have the biggest drug makers figured out how to avoid infractions, or are they simply shying away from some efforts?We asked the FDA for insight and will update you accordingly.center_img Related: Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] FDA settles lawsuit, rescinds warning letter About the Author Reprints Tags drug makersdrug marketingFDAlast_img read more

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first_img Dr. Shanna Levine, instructor at the Icahn School of Medicine at Mount Sinai, who was not involved in the study, agrees with its conclusion that BMI is not a good surrogate for fat. When counseling her patients, Levine advises them not to fixate on the bathroom scale but to focus on how their clothes fit because that’s a better indication of their body composition and weight distribution. Columnist, Off the Charts Jennifer Adaeze Okwerekwu is a psychiatrist and a columnist for STAT. Tags fatobesityweight gain By Jennifer Adaeze Okwerekwu March 7, 2016 Reprints Your body’s fat percentage is a better predictor of health risks than the number you see on the scale, confirms a new study.Body mass index — a ratio of weight to height — is still widely used in doctors’ offices. But it’s an imperfect measure of body fat and, therefore, researchers say, categorizes some muscular people as being overweight.Now, a new study of more than 50,000 middle-aged and older adults reveals that a high body fat percentage, but not high BMI, is a risk factor for near-term death. Researchers examined the medical charts and X-rays of people in Manitoba, Canada, who had gotten osteoporosis screenings between 1999 and 2013. They calculated BMI based on the patient’s medical chart, and body fat based on the area seen in the scan.advertisement The study found that high body fat percentage — defined as greater than 38 percent fat in women and greater than 36 percent fat in men — was associated with increased mortality over an average of 4-6 years.The study also found that people with a low BMI face a greater risk for death. That may be because low muscle mass reflects unhealthy weight loss, or the frailty associated with chronic disease. The results were published Monday in Annals of Internal Medicine.advertisement [email protected] About the Author Reprints “Healthy body composition is not just thinness,” said study author Dr. William Leslie at the University of Manitoba.The study’s wider application is limited in a few ways. Most of the participants in the study were white females, and the study didn’t track participants’ BMI or body fat over time. Some relevant data, such as whether participants smoked, wasn’t collected.Despite these limitations, Leslie believes the study had general implications for both patients and physicians. “It attunes them to the fact that weight and BMI are not the be-all and end-all,” he said.Though the average person won’t have access to high-tech X-ray machines, Leslie said assessing body fat composition “can be as simple as just looking at somebody” or measuring waist circumference. Skin tissue folds or low overall fitness would also be signs of more fat. Can detox waters really flush your fat and toxins away? Related: @JenniferAdaeze Jennifer Adaeze Okwerekwu M. Spencer Green/AP Can detox waters really flush your fat and toxins away? HealthBody fat may be more significant than weight in predicting health risks Related:last_img read more

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first_img @ravi_b_parikh Why health care needs a Steve Jobs-style disruptor By Ravi Parikh March 15, 2016 Reprints A prospective patient of mine missed his first appointment in my primary care clinic. In addition to getting a thorough checkup, he was scheduled to get some vaccinations, including one against the viral infection known as shingles.I got a call from the man two months later. He apologized profusely for missing the appointment. And unfortunately, he had another reason for calling: he had developed a painful rash across his left lower torso, the hallmark of shingles.It took two weeks of treatment before his rash disappeared, and he suffered months of pain. But it could have been avoided if he’d been able to get a shingles vaccine without having to leave his home.advertisement Similarly, large health systems have been consolidating health care into their own “supercenters” — hospitals and medical centers. This consolidation has come at the expense of care in patients’ homes. In the 1940s, house calls represented 40 percent of all doctors’ visits. Today they represent less than 1 percent of all consultations.Just as online retailers have threatened the dominance of Walmart, new entrants into the health care market threaten the dominance of clinic- and hospital-based doctors. San Francisco-based Doctor on Demand provides access to video-based doctors who can treat common conditions like colds, sore throats, urinary tract infections, and sports injuries for a flat fee of $40 per visit. Boston-based American Well offers telemedicine solutions for employers and health systems. And transportation innovator Uber has completed its second round of testing of UberHEALTH, an on-demand service delivering flu shots in 35 cities. A proof-of-concept study of the first round, published in the Annals of Internal Medicine, showed that more than 2,000 individuals received flu shots at home — one of the most common reasons for a clinic visit. Doctors revive house calls for children with serious illnesses First OpinionLessons for health care from Walmart, Amazon, and Uber Providing health care at home is on the minds of many doctors and health system CEOs who are coming to realize that the traditional model of hospital- and clinic-centric care may not be financially viable. A recent analysis by Modern Healthcare showed that profits in large hospitals and clinics declined in 2014 despite an improving economy.There is a stark parallel between this trend and the decline of traditional retail stores. Take Walmart as an example. In the late 1990s, Walmart expanded its large department stores. These supercenters forced out many smaller mom-and-pop retailers. But the company recently announced it was closing 154 stores in the United States, and more overseas. This move was sparked in part by the disruptive influence of Amazon and other online retailers, which let people shop from the comfort of their homes.advertisement Related:center_img Even Walmart is getting into the act. It has created more than 100 in-store retail clinics staffed by nurse practitioners and branded as “one-stop shops” for primary care.As a future primary care provider, I hope that our system can bridge the divide between our traditional medical behemoths and these innovative organizations. Doctors learn to practice medicine in the environments in which they are taught. In medical school and residency, I’ve learned in the safe confines of the hospital and primary care clinic. But I also hope to practice in a novel delivery system that cares for patients where they are — not where it’s most convenient for me to provide care.We need new ways to care for our patients. When they miss primary care appointments, we make no effort to understand why — until it is too late. And we make no effort to address those reasons by shifting where we provide care. Instead, we send them phone calls and emails: “You missed your last primary care visit. If you continue to miss your visits, we may drop your from this practice.” For my patient with shingles, I should have been able to employ a service like UberHEALTH to deliver his vaccines to him, when he needed them. It could have prevented a prolonged, painful condition.Instead of “firing” customers who are no longer stepping through its Supercenter doors, Walmart is working to find ways to serve them. Hospitals and medical clinics should make a similarly large investment to bring health care to our patients — or risk losing them to the Amazons of our own field.Ravi Parikh is a resident in internal medicine and primary care at Brigham and Women’s Hospital in Boston. A Walmart pharmacy intern speaks with a customer. Sarah Bentham/AP About the Author Reprints Tags home carehospitalspatients Related: [email protected] Ravi Parikhlast_img read more

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first_imgThe latest analysis does have some limitations, though. Related: Privacy Policy Leave this field empty if you’re human: About the Author Reprints The analysis arrives as drug ads — which are only permitted in the United States and New Zealand — come under fire as a means by which the pharmaceutical industry promotes expensive medicines that increase health care costs. Ad spending soared more than 60 percent in the last four years, hitting $5.2 billion last year. The American Medical Association has called for a ban, and one Washington lawmaker wants to eliminate advertising tax breaks for drug makers.Whether such efforts will prompt any changes is uncertain, but they are being raised partly in response to the increasing cost of prescription medicines, a hot-button issue that has angered many Americans. As a result, the virtues of drug advertising — which has been widely debated on and off for many years — are once again being scrutinized.advertisement PharmalotAll that pharmaceutical advertising may be a ‘mixed bag,’ after all By Ed Silverman Sept. 13, 2016 Reprints Amid the ongoing debate over the wisdom of pharmaceutical advertising, a new analysis suggests that doctors agree more often than not to write prescriptions for patients who have seen drug ads. At the same time, however, the analysis also found that only 1 in 10 consumers were moved by such advertising to ask a doctor for a prescription.The results present a slightly conflicting picture of the extent to which so-called direct-to-consumer advertising poses an unhealthy dilemma, according to the authors of the analysis, published Tuesday in the Journal of Clinical Psychiatry. While the pharmaceutical industry insists its ads educate consumers, doctors argue some ads too often encourage patients to seek medicines unnecessarily.“I think the data suggests that, if you take a deep dive, we see a mixed bag,” said Sara Becker, an assistant professor of behavioral and social sciences at Brown University, who coauthored the analysis. “Across the board, consumer requests (for prescriptions in response to drug ads) are not happening all that often. But when it does, it raises prescribing volumes.”advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. @Pharmalot Tags drug adsDTC Advertisingprescription drugs Drug makers now spend $5 billion a year on advertising. Here’s what that buys. In an effort to capture what the researchers considered real-time activity involving patient requests and physician prescribing, they ignored after-the-fact surveys. Instead, they reviewed studies that tracked interactions between patients and doctors at what they called the point of service. However, they found just four studies to analyze, but these had not uniformly explored the topic in the same way.For instance, one was a randomized, controlled trial that looked only at the effect of advertising on prescribing antidepressants, and actors were hired to role play. The other three were observational studies, including one that examined prescribing a wider variety of medicines in Canada, where drug advertising is not permitted, although many Canadians may well view ads that can be seen in the US.[UPDATE: It is also worth noting that those three observational studies did not address the extent to which patients may have actually needed medicines for which they sought prescriptions. Becker called this a “big, unanswered question.”]“Our review doesn’t necessarily suggest that advertising is horrible or great,” said Becker. “Although we’re moderately confident that this tells us there can be competing effects on the quality of treatment quality — both better patient adherence and overprescribing. It may have helped in some cases, but less so in others. But more research is needed.” APStock Newsletters Sign up for Pharmalot Your daily update on the drug industry. [email protected] Please enter a valid email address. Ed Silvermanlast_img read more

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first_imgHealthWatch: For two brothers with Duchenne, an FDA drug approval brings joy and relief Meet Max and Austin Leclaire. They have Duchenne muscular dystrophyVolume 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 Linkhttps://www.statnews.com/2016/09/20/duchenne-fda-drug-sarepta-brothers/?jwsource=clCopied EmbedCopiedLive00:0001:4401:44  Related: Max and Austin Leclaire have lived a lot of hard days together. The brothers have Duchenne muscular dystrophy, a rare degenerative disease that wastes their muscles and will likely take their lives at an early age.Over the last few years, they found a glimmer of hope in an experimental drug, called eteplirsen. Max was able to get on the drug in 2011. Austin started on it three years later in another clinical trial. Both boys believe it has helped slow their physical decline. And Max has remained able to walk, although not easily, beyond the age when boys with Duchenne usually lose the use of their legs. “It was a pretty big relief,” Austin said, “but I was more worried about the other kids, that if it didn’t get approved, they wouldn’t have a chance.” Scientists at the FDA were deeply divided, but on Monday, the agency finally approved the drug. It’ll be available within a few months, at an estimated price of $300,000 a year.The approval pleased Max, 14, and Austin, 17. And not just because they hope to keep taking the drug.advertisement Episode 2: For boys with Duchenne, and two drug companies, a moment of shared hope The company that developed the drug, Sarepta Therapeutics, has been pushing hard for federal approval to take it to market. It doesn’t have a lot of hard data that it works; in part because Duchenne muscular dystrophy is so rare, Sarepta presented data on just a handful of patients to the Food and Drug Administration.advertisement Tags clinical trialsduchenne muscular dystrophyFDASarepta Therapeutics These are some of the hopes and fears of two brothers living with a rare, deadly disease. Alex Hogan, Hyacinth Empinado, Jeffery DelViscio/STAT By Jeffery DelViscio Sept. 20, 2016 Reprintslast_img read more

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first_img What’s included? Log In | Learn More By Robert Weisman — Boston Globe June 13, 2017 Reprints Sculley on digital health care: ‘the most interesting thing I’ve seen since Apple’ What is it? Robert Weisman — Boston Globe Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Former Apple CEO John Sculley, who had a famously hot-and-cold relationship with Apple founder Steve Jobs, says the next multibillion-dollar opportunity to change the world is in digital health care.Sculley has surfaced as chief marketing officer at the Southborough, Mass., startup RxAdvance, a cloud-based software company where he is working with founder and CEO Ravi Ika to disrupt the giant industry of managing pharmacy benefits. [email protected] @GlobeRobW GET STARTED Business About the Author Reprints John Sculley Brad Barket/Getty Images for Kairos Society 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. 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. Tags drug pricingpharmaceuticalsSTAT+last_img read more

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first_imgFirst OpinionTo better treat the opioid crisis, call in the journalists? Related: But it certainly wasn’t a small ask. We aren’t used to having reporters observing us as we work, and we were nervous that if we gave up editorial control we could run the risk of being inaccurately represented. Even so, we agreed to this intriguing proposition. High-quality journalism, we thought, might be able to shed light on the pressing problem of opioid abuse by uncovering deeper truths, highlighting things we just weren’t seeing, and exploring varying perspectives, all of which could help us better address the crisis and improve our approach with patients. Related: Right from the get-go, we were in the thick of the two-month-long reporting process. Various teams of reporters and sound engineers recorded interviews with members of our team and the Northwell Health Opioid Management Steering Committee. They shadowed clinicians as they went about their work. With help from the Northwell public relations team, they interviewed a patient and his psychiatrist. We also invited the journalists to observe a training session for medical office assistants, nurses, and health coaches on our Screening, Brief Intervention, and Referral to Treatment (SBIRT) service, which helps identify patients whose alcohol, drug, or tobacco use may be interfering with their health before it becomes a lifelong addiction. That piqued the journalists’ interest about our focused educational efforts on substance abuse underway at the Hofstra Northwell School of Medicine.advertisement The focus of the series was on the stories of providers, patients, and family members, as well as the steps we were taking to address any gaps in clinical care and clinical training.Even though my colleagues and I know quite a bit about the opioid and heroin crisis, since we deal with it firsthand as health care providers, participating in the project gave us a clearer understanding of the epidemic. In our state, New York, more than 110,000 residents are treated daily in the Office of Alcoholism and Substance Abuse Services system. It monitors a statewide network of certified treatment providers that operate more than 1,100 programs. That includes the direct operation of 12 addiction treatment centers, which provide inpatient rehabilitation services to more than 10,000 persons per year. Some states have even more difficult struggles, particularly Ohio and West Virginia. This epidemic is truly nationwide.Our hope, when we first agreed to participate in this project, was that it would provide additional perspectives and serve as a learning opportunity for our team and other Northwell clinicians. The final product, “The Fix: Treating New York’s Opioid Crisis,” certainly delivered on that promise.When we treat patients, most of us are laser focused on giving them the best care possible and sometimes saving them from life-threatening afflictions. We often don’t create opportunities for our patients to feel comfortable discussing their use of alcohol or drugs, which can constrain the flow of relevant information that can better inform clinical delivery and care plans. As we see the daily escalation of the opioid crisis in our communities, it is evident that there is no “face” to addiction. It can affect homemakers, students, lawyers, health care professionals, and construction workers. The podcast highlights this as folks from all walks of life share their accounts of addiction and how they could have been addressed, prevented, and better treated. [email protected] Dr. Sandeep Kapoor leads a seminar on Northwell Health’s service that helps identify patients whose alcohol, drug, or tobacco use may be interfering with their health. Joaquin Cotler/GroundTruth @NorthwellSBIRT About the Author Reprints By Sandeep Kapoor June 14, 2017 Reprints How drug use changes the brain — and makes relapse all too common One of the privileges of being a health care provider these days is having access to innovative technologies designed to help save lives. My colleagues and I were recently surprised to discover a powerful tool that could be useful in our line of work: journalists.I am part of an interdisciplinary team that focuses on finding better ways to identify, intervene, and treat substance misuse/abuse. We were approached by The GroundTruth Project, a nonprofit journalism organization, which was seeking underwriting from the Northwell Health Foundation, which is affiliated with my employer, Northwell Health. The journalists wanted to create a five-part podcast series on the problem of opioid and heroin addiction and requested access to our team. It also wanted the opportunity for various reporters to be a “fly on the wall” during physician-patient encounters. The one stipulation: In the spirit of true journalism, my colleagues and I would have absolutely no editorial control of the finished product.We certainly understood the reporters’ and editors’ interest in this project: Opioid abuse represents a major health care crisis, and our organization has been proactive in creating and piloting potential solutions to better address the epidemic.advertisement Sandeep Kapoor The project also brought to light a fundamental problem with clinicians’ skill sets related to substance misuse: In the current landscape of clinical education and training, the average physician receives just four hours of instruction related directly to addressing substance use. The same is true for most other health professionals. As a result, few feel comfortable talking with patients about substance abuse and addiction. And talk we must. To meet the challenges of the opioid epidemic, we need to become accustomed to asking patients about substance use as naturally and comfortably as we discuss blood pressure, blood sugar, and weight.Much remains to be done for the country to overcome the opioid epidemic. Policies must change, patient-centered treatment models need to be developed, and the hardships that drive millions of Americans to feel hopeless must be met and conquered.We try to teach every young doctor that you can’t really care for a patient unless you care about him or her as a whole person. What better way to show and grow this basic empathy than by learning how to have meaningful, sometimes difficult, and absolutely necessary conversations about substance use and abuse?Participating in the podcast, developed in the spirit of neutrality and objectivity, helped us validate this commitment. We’re grateful to The GroundTruth Project for this insightful look at the many facets of the opioid epidemic as we work to stand up as a community and offer solutions to address it.Sandeep Kapoor, M.D., is an assistant professor of medicine at Hofstra Northwell School of Medicine in Hempstead, N.Y., and director of Northwell Health’s Screening, Brief Intervention, and Referral to Treatment service. Watch: ‘Like you’re living in hell’: A survivor on what opioid withdrawal did to his body Tags addictioneducationopioidsphysicianslast_img read more

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first_imgIn the LabMemory transferred between snails, challenging standard theory of how the brain remembers “If he’s right, this would be absolutely earth-shattering,” said Tomás Ryan, an assistant professor at Trinity College Dublin, whose lab hunts for engrams, or the physical traces of memory. “But I don’t think it’s right.”advertisement @ushamcfarling NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. Exclusive analysis of biopharma, health policy, and the life sciences. LOS ANGELES — UCLA neuroscientists reported Monday that they have transferred a memory from one animal to another via injections of RNA, a startling result that challenges the widely held view of where and how memories are stored in the brain.The finding from the lab of David Glanzman hints at the potential for new RNA-based treatments to one day restore lost memories and, if correct, could shake up the field of memory and learning.“It’s pretty shocking,” said Dr. Todd Sacktor, a neurologist and memory researcher at SUNY Downstate Medical Center in Brooklyn, N.Y. “The big picture is we’re working out the basic alphabet of how memories are stored for the first time.” He was not involved in the research, which was published in eNeuro, the online journal of the Society for Neuroscience.advertisement Many scientists are expected to view the research more cautiously. The work is in snails, animals that have proven a powerful model organism for neuroscience but whose simple brains work far differently than those of humans. The experiments will need to be replicated, including in animals with more complex brains. And the results fly in the face of a massive amount of evidence supporting the deeply entrenched idea that memories are stored through changes in the strength of connections, or synapses, between neurons. The results, said Glanzman, suggest that memories may be stored within the nucleus of neurons, where RNA is synthesized and can act on DNA to turn genes on and off. He said he thought memory storage involved these epigenetic changes — changes in the activity of genes and not in the DNA sequences that make up those genes — that are mediated by RNA.This view challenges the widely held notion that memories are stored by enhancing synaptic connections between neurons. Rather, Glanzman sees synaptic changes that occur during memory formation as flowing from the information that the RNA is carrying.“This idea is radical and definitely challenges the field,” said Li-Huei Tsai, a neuroscientist who directs the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology. Tsai, who recently co-authored a major review on memory formation, called Glanzman’s study “impressive and interesting” and said a number of studies support the notion that epigenetic mechanisms play some role in memory formation, which is likely a complex and multifaceted process. But she said she strongly disagreed with Glanzman’s notion that synaptic connections do not play a key role in memory storage.Trinity College’s Ryan, like Glanzman, stands with a minority of neuroscientists — some call them rebels — who question the idea that memory is stored through synaptic strength. In 2015, Ryan was lead author of a Science paper with MIT Nobelist Susumu Tonegawa that showed memories could be retrieved even after synapse strengthening was blocked. Ryan said he is pursuing the idea that memories are stored through ensembles of neurons bound together by new synaptic connections, not by strengthening of existing connections.Ryan knows Glanzman and trusts his work. He said he believes the data in the new paper. But he doesn’t think the behavior of the snails, or the cells, proves that RNA is transferring memories. He said he doesn’t understand how RNA, which works on a time scale of minutes to hours, could be causing memory recall that is almost instantaneous, or how RNA could connect numerous parts of the brain, like the auditory and visual systems, that are involved in more complex memories. Glanzman knows his unceremonial demotion of the synapse is not going to go over well in the field. “I expect a lot of astonishment and skepticism,” he said. “I don’t expect people are going to have a parade for me at the next Society for Neuroscience meeting.”Even his own colleagues were dubious. “It took me a long time to convince the people in my lab to do the experiment,” he said. “They thought it was nuts.”Glanzman’s experiments — funded by the National Institutes of Health and the National Science Foundation — involved giving mild electrical shocks to the marine snail Aplysia californica. Shocked snails learn to withdraw their delicate siphons and gills for nearly a minute as a defense when they subsequently receive a weak touch; snails that have not been shocked withdraw only briefly.The researchers extracted RNA from the nervous systems of snails that had been shocked and injected the material into unshocked snails. RNA’s primary role is to serve as a messenger inside cells, carrying protein-making instructions from its cousin DNA. But when this RNA was injected, these naive snails withdrew their siphons for extended periods of time after a soft touch. Control snails that received injections of RNA from snails that had not received shocks did not withdraw their siphons for as long.“It’s as if we transferred a memory,” Glanzman said.Glanzman’s group went further, showing that Aplysia sensory neurons in Petri dishes were more excitable, as they tend to be after being shocked, if they were exposed to RNA from shocked snails. Exposure to RNA from snails that had never been shocked did not cause the cells to become more excitable. National Science Correspondent Usha covers the toll of Covid-19 as well as people and trends behind biomedical advances in the western U.S. Please enter a valid email address. Hyacinth Empinado/STAT By Usha Lee McFarling May 14, 2018 Reprints Recently, developmental biologist Michael Levin at Tufts has replicated McConnell’s experiments on headless worms under more controlled settings and thinks McConnell may have indeed been correct.Glanzman said one of McConnell’s students, Al Jacobson, demonstrated the transfer of memories between flatworms via RNA injections, coincidentally while an assistant professor at UCLA. The work was published in Nature in 1966 but Jacobsen never received tenure, perhaps because of doubts about his findings. The experiment was, however, replicated in rats shortly afterward.Glanzman learned about McConnell’s work — and his satirical journal “Worm Runner’s Digest” — while he was a psychology undergraduate at Indiana University but never took the results seriously. Now, while he’s still not convinced McConnell was exactly right about being able to transfer memories, he does think both McConnell and Jacobson were onto something.Working in the memory field can be tough for those who challenge the status quo. SUNY’s Sacktor, for example, has spent more than 25 years — despite the skepticism, rejection, and outright derision of fellow scientists — chasing down a single molecule, PKMzeta, that he believes is critical to the formation of long-term memories and may be connected to the RNA mechanisms that Glanzman has uncovered.The stakes in the field are high because memory is so key to our sense of self and many scientists feel understanding the workings of memory is something that should have been figured out by now. “It’s the last of the great 20th-century questions in biology,” Sacktor said. “Some aspect has made it difficult for neuroscientists to figure out.”The difficulty may be due in part to the overwhelming focus on synaptic strength. Some 12,000 papers have been published on synaptic strength without providing a good explanation for how memories are stored, Ryan noted, adding that he applauds Glanzman for opening up a new path, radical as it is, to explore.“The reality is we know so little about memory,” Ryan said. “I’m excited about any new vistas and avenues.” Leave this field empty if you’re human: But Glanzman said he is convinced RNA is playing a role that eclipses the synapse. In 2014, his lab showed that memories of shocks that had been lost in snails due to a series of experimental procedures could be recovered — but the synapse patterns that were lost with the memory reformed in random ways when the memories were recovered, suggesting memories were not stored there. Glanzman’s lab and others have also shown that long-term memory formation can be blocked by preventing epigenetic changes, even when synapse formation or strengthening is not altered.“Synapses can come and go, but the memory can still be there,” he said, saying he sees synapses as merely the “reflection of knowledge held in the nucleus.”Glanzman has studied memory for more than three decades. He did postdoctoral work with none other than Eric Kandel — the neuroscientist who shared the 2000 Nobel prize for research on Aplysia, probing the role of the synapse in memory — and he said he has spent most of his career believing that synaptic change was the key to memory storage.But he said a series of findings from other labs and his own in recent years have led him to start questioning the synaptic dogma. He calls himself “a recovering synaptologist.”The skepticism over Glanzman’s research may be in part because the work harkens back to an unnerving episode in science involving an unconventional psychologist, James V. McConnell, who spent years at the University of Michigan attempting to prove that something outside the brain — a factor he called “memory RNA” — could transfer memories. In the ’50s and ’60s, McConnell trained flatworms and then fed the bodies of trained worms to untrained worms. The untrained worms then appeared to exhibit the behavior of the trained worms they’d cannibalized, suggesting that memories were somehow transferred. He also showed that trained worms that were beheaded could remember their training after they grew new heads.Though the work was replicated by some other labs, McConnell’s work was largely ridiculed and is often described as a cautionary tale because so much time and money was spent by other labs trying, often unsuccessfully, to replicate the work. (McConnell died in 1990, five years after he’d been a target of the Unabomber Theodore Kaczynski.) “I expect a lot of astonishment and skepticism. I don’t expect people are going to have a parade for me at the next Society for Neuroscience meeting.” Usha Lee McFarling Controversial study challenges scientific consensus that adult brains make new neurons Related: About the Author Reprints David Glanzman, UCLA STAT+: [email protected] Privacy Policy Tags neuroscienceresearchlast_img read more

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first_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. By Ed Silverman March 13, 2019 Reprints @Pharmalot What’s included? Amid the ongoing opioid crisis, a U.S. lawmaker is pressing a professional medical society that also functions as a patient advocacy group to disclose detailed information about its ties to drug makers over concerns it tried to sway government moves to curb opioid prescribing.In a March 12 letter, Sen. Ron Wyden (D-Ore.) instructed the American Academy of Pain Medicine to provide a raft of documents, including tax filings; a list of payments from drug and device makers made to the group and its top officer; information about work performed for opioid maker Purdue Pharma; continuing medical education coursework; and its conflict of interest policy, among other things. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED 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. [email protected] What is it?center_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. Ed Silverman Wyden probes a patient advocacy group over its ties to opioid makers About the Author Reprints Sen. Ron Wyden (D-Ore.) Susan Walsh/AP GET STARTED Pharmalot Tags CongressopioidspharmaceuticalsSTAT+last_img read more

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first_img Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and refreshing, because that oh-so-familiar routine of meetings, deadlines, calls, and the like has, of course, returned. You knew this would happen, yes? After all, the world keeps spinning no matter how hard we try to slow things down a bit. So what else is there to do but reach for a cup of stimulation — our choice is whiskey-flavored Jack Daniels — and get started on the journey? Hope yours goes well and, as always, do keep in touch …Pfizer (PFE) plans to acquire Array Biopharma (ARRY) for $11.4 billion in cash, which is known not only for developing its own medicines but as being a top choice among biotechnology firms that need to synthesize new drugs, STAT writes. The deal gives Pfizer access to a pair of drugs that are approved for treating metastatic melanoma. The combined therapy is currently being tested in more than 30 clinical trials for other tumor-related diseases, such as metastatic colorectal cancer. Ed Silverman @Pharmalot Alex Hogan/STAT Pharmalot Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Pharmalittle: Pfizer to buy Array for $11 billion, Teva settlement in Oklahoma may hit a new snag What is it? 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. About the Author Reprintscenter_img What’s included? Log In | Learn More Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. GET STARTED [email protected] By Ed Silverman June 17, 2019 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. Tags legalMedicaidMedicareopioidspharmaceuticalsSTAT+last_img read more

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