Gene drive gives scientists power to hijack evolution

first_img 320 CRISPR publications from 2002 to 2013 20022003200420052006200720082009201020112012201320142015 Scientists hope to use gene drive to stop mosquitos from spreading malaria and dengue. Valery Hache/AFP/Getty Images Kenneth Oye, Massachusetts Institute of Technology @sxbegle Austin Burt, Imperial College London In the LabGene drive gives scientists power to hijack evolution In an attempt to identify possible ramifications of gene drives, the National Academy of Sciences has assembled experts to assess current regulations and recommend whether additional oversight is needed. The committee held its first meeting in July and will hold its sixth this week.The Academy panel is expected to deliver a report next spring on, among other questions, biological techniques to reduce the risk of unintended consequences of gene drives.From the evidence so far, however, the science threatens to outrace efforts to ensure that gene-drive research is conducted safely. For one thing, the key molecular tools are as easily available as tea cosies on Etsy. “In terms of parts you can buy on eBay,” Esvelt said, “probably for less than $10,000 you could” construct a gene drive. Flouting DarwinTwo groundbreaking discoveries facilitated the surge in gene-drive experiments. One was theoretical. In 2003 evolutionary biologist Austin Burt of Imperial College London outlined an ingenious way to flout the laws of both inheritance and evolution.For more than a century, geneticists have known that, in organisms that pair up to reproduce, most genes have a 50-50 chance of being inherited, as Gregor Mendel famously showed in the 19th century with pea plants. Thanks to Mendelian inheritance, offspring carry either mom or dad’s version of the gene for, say, digesting lactose. Similarly, evolutionary biologists have known since Charles Darwin that natural selection eliminates inherited traits that reduce organisms’ fitness, such as mosquitoes’ susceptibility to the insecticide DDT.Burt described how gene drive can outsmart both Mendel and Darwin. In nature, he noted, some genes copy themselves into multiple places in a genome. Like a dishonest candidate stuffing the ballot box, these extra copies increase a gene’s odds of “winning” — being inherited. Other genes destroy related ones, also ensuring their transmission into the next generation.Although this natural gene drive is unpredictable and scattershot, Burt showed that certain tricks of molecular biology could achieve the same results: causing a gene to be inherited by many more organisms through many generations than standard genetics and natural selection allow. But because the then-available laboratory tricks were inefficient and cumbersome, his idea lay on the shelf for nearly a decade.Things changed abruptly in 2012. In a paper that June, scientists demonstrated how it might be possible to efficiently edit genes — that is, how to snip DNA at a particular spot and insert different DNA, a sort of biological version of word processing’s “find and replace.” This system, called CRISPR-Cas9, makes gene drive feasible. The 2012 paper used DNA in a test tube, but within six months researchers had built on it to edit genes in plants and animals.“Since the 1970s we’ve been able to genetically engineer individual organisms,” Burt told STAT. “With gene drive” made practical by CRISPR, “we could change the genetics of vast populations.” Tags CRISPRevolutiongene editing Sharon Begley But gene drives might also doom important species to extinction, change the course of evolution, and perhaps be used to create bioweapons. That has caught the attention of the United Nations office that oversees the biological weapons treaty as well as of the FBI’s Weapons of Mass Destruction directorate, as STAT reported last week. And a science meeting Thursday includes an eye-catching agenda item: gene drive’s potential for “entomological warfare.”  Meet ‘CRISPR’Volume 90%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 EmbedCopiedLive00:0000:5700:57  “Most gene drive research is being done in academic and government labs,” said Dr. Amesh Adalja, an infectious disease and biosecurity expert at the University of Pittsburgh Medical Center who will be speaking at the National Academy of Sciences meeting. “But if a lone wolf or terrorist group is working on this, the regulation [of gene drives that government officials are contemplating] wouldn’t make any difference.”advertisement (Visualization by Talia Bronshtein/STAT; Source: PubMed)Drag timeline handles to filter CRISPR studies by year, and hover over or click the colored circles to see publication details.In their July 2014 paper, Esvelt and his colleagues described how gene drive would work: CRISPR would cut a target gene in a cell or cells, probably an egg or embryo. Cells would repair the cut by incorporating replacement DNA, also carried by CRISPR, resulting in an edited genome. Unlike in traditional genetic engineering, where researchers slip a foreign gene into an organism’s genome and call it a day, for gene drive they would insert, along with the replacement gene, what is essentially a molecular Xerox machine.The copier would reproduce the replacement gene in such a way that almost every descendant of the engineered organism would inherit two copies of the introduced gene. After enough generations (exactly how many depends on factors such as generation length and how many organisms are engineered), every descendant would carry the foreign gene.CRISPR-aided gene drive might be harnessed to target insect-borne disease. If CRISPR replaced the gene in mosquitoes that lets them detect the odor of people, and substituted a dud, and if gene drive ensured the dud was carried by both chromosomes, then every offspring would have a double dose of the dud. Eventual result: mosquitoes that can’t smell humans, reducing their odds of biting. Modifying malaria-carrying mosquitoes in this way could reduce the spread of a disease that kills an estimated 600,000 people every year.This possibility was purely speculative when Esvelt and his colleagues outlined it in the summer of 2014. No one had used CRISPR-aided gene drive in mosquitoes or any other insect. Then the fruit-fly paper landed.‘We were stunned’Graduate student Valentino Gantz of the University of California, San Diego and his advisor, biologist Ethan Bier, didn’t set out to create a gene drive. Gantz was studying which genes produce the intricate vein patterns in the wings of fruit flies. To do that, he needed to create a menagerie of mutants, including some flies with multiple mutations — painstaking, time-consuming work.“We thought, wouldn’t it be cool if you could come up with a trick that would give you the mutants you wanted in one generation?” Bier recalled. That trick was CRISPR. In the summer of 2014, Gantz used CRISPR to edit wing-vein genes. “We immediately understood that [the edited gene] could potentially propagate in a way that would lead to gene drive,” Bier said.They therefore took precautions. Gantz conducted the experiment behind five sets of locked doors that required fingerprint identification to open. He housed the flies in a tube inside a tube inside a box. “And we thought it would be safer if I worked alone,” Gantz said, to minimize the chance that a mutant fly the size of a pinhead would hitch a ride on a human into the wilds of southern California.Among the changes Gantz inserted in his flies with CRISPR was a gene for yellow pigmentation. That would be easier to spot than a wing-vein pattern. Gantz started the experiments in late November 2014. On Dec. 18 he saw the first signs of success: flies born from the CRISPR-modified embryos were yellow. He had edited the embryos’ genomes. Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery.center_img “Man, are things moving fast.” “With gene drive, we could change the genetics of vast populations.” Hence Esvelt’s alarm that he had never heard of the authors of the fruit-fly study, though he had spent weeks tracking down every scientist he thought was working on gene drives to get them to agree to proceed carefully. “I was kicking myself,” Esvelt said.No experiments using gene drives in vertebrates, let alone humans, are known to be underway. But a growing number of labs are working with the technology in about six species, estimated Esvelt, a research fellow at the Wyss Institute for Biologically Inspired Engineering in Boston. As political scientist Kenneth Oye of MIT put it, “Man, are things moving fast.”How fast?In July 2014, Esvelt’s group, led by Harvard biologist George Church, laid out in the journal eLife the theoretical uses of gene drives and how to construct them using the powerful new molecular technique called CRISPR. They knew of no lab doing such work.By January, Esvelt and colleagues reported creating gene drives in yeast, getting more than 99 percent inheritance; they’re also making gene drives in roundworms, partly to work out the basic recipe and partly in hopes that gene drives might eliminate diseases caused by the creatures.In March, the fruit-fly scientists published the paper that shocked Esvelt. Then came the real test, determining whether the recessive yellow gene drove out dominant genes for other colors. Gantz mated the yellow flies to unedited ones. Their progeny hatched last Dec. 28. Nearly all — 97 percent — were yellow. It was an astonishing violation of the textbook laws of inheritance, which say only one in four offspring should express the recessive yellow trait. He had constructed a gene drive.“We were stunned,” Bier recalled. The CRISPR-based gene-drive system “completely eliminated Mendelian constraints. It will revolutionize genetics.” What is a gene drive?Volume 90%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 EmbedCopiedLive00:0001:4101:41  At a 97 percent rate of inheritance, one lone mosquito carrying an edited gene that prevents it from spreading malaria could make an entire population of mosquitoes resistant to the disease in less than a year.Scientists had been trying to genetically engineer mosquitoes to stop spreading malaria for nearly two decades, without much success. A leader in that effort has been biologist Anthony James of the University of California, Irvine. In 2012, James’s team developed a mosquito that, thanks to a genetic tweak, produced antibodies against the malaria microbe, destroying it before it could be transmitted to the mosquito’s next blood meal. His lab has accomplished similar feats with mosquitoes that carry the dengue virus, but the genetic engineering has been inefficient and laborious.Once the UCSD duo had their gene-drive flies, they e-mailed James. “Holy s***!” James replied. “Can we do it in mosquitoes?”To find out, the two labs are collaborating. They’re using CRISPR to edit a mosquito genome to block the insect from spreading malaria or dengue, and gene drive to make every descendant inherit the trait. The team declined to divulge results, but James called them “promising.”“We think we can make it so it’s completely impossible for a mosquito to propagate malaria,” Bier said.In London, Burt and fellow Imperial College London biologist Andrea Crisanti are also trying to harness gene drive to disarm malaria mosquitoes. “We’re mostly focused on disrupting reproduction,” Burt said. Using an enzyme that targets some 200 sites on the X chromosomes in mosquito eggs, the team has managed to shred X chromosomes so thoroughly “that it’s too much for the cell to repair,” Burt said. The result: eggs carry only the Y chromosome, which makes sons, and no X, which makes daughters.So far, they have gotten 95 percent sons using an editing tool other than CRISPR. And in a paper submitted to a journal, they will report that “CRISPR works in Anopheles,” the malaria-carrying mosquito, Crisanti said. “It speeds up” genome editing and gene drive “quite a bit.”Whether other labs are secretly developing gene drives is, of course, impossible to say. Esvelt has made it his mission to keep that from happening. “I strongly believe we have a moral obligation to let others know when our research could directly impact their lives, and gene drives are a poster child when it comes to shared impact,” he said. “Working with community guidance is arguably the only ethical way to proceed.”Unintended consequencesEsvelt heard about the UCSD paper a few days before it was published in Science last March. He immediately Skyped Bier to ask what precautions he had taken.When Bier told him about the tube-in-a-tube-in-a-box confinement, Esvelt asked whether it was earthquake-proof. “I’ve thrown these things against walls, and still, the caps [on the tubes] don’t come off,” Bier recalled saying. “Even in an earthquake … This is not some kind of monster that can’t be confined.”Esvelt wasn’t so sure Bier’s precautions were adequate. The UCSD scientists’ confinement system was “problematic,” he said. It “encourages other laboratories to do the same, which will eventually lead to an accidental release.” Even if such an accident had no ecological consequences, he added, it would make scientists seem like careless DNA cowboys, perhaps leading to calls to shut down gene-drive research.Esvelt stepped up his efforts to get labs to agree to specific biosafety steps to prevent the escape of mutant organisms carrying gene drives, including inserting a sort of biological kill switch. The resulting letter was published in the journal Science in July with 27 signatories, including researchers from the only teams that have reported using CRISPR-aided gene drives — at the Wyss and at UCSD. Taking their own advice, Esvelt and Church, who are authors of a patent filed on one form of gene drive, reported Monday that they had constructed biological machinery able to “overwrite” a CRISPR gene drive in laboratory yeast. Although the original gene drive remains in the organisms, it’s inactive.Such reversibility, they say, could minimize the chance of gene drives released into the wild turning into an ecological disaster. That’s crucial, especially since releasing into the wild is exactly how gene drives could accomplish what their proponents envision. On the afternoon that Esvelt told STAT about his shock at the unexpected UCSD paper, he’d spent the morning with scientists from Australia asking whether gene drive could rid the island of cane toads. Introduced to Australia in 1935 to control beetles that were devouring sugarcane crops, the poisonous predators (native to South America) have been spreading unchecked. Toxic to birds, the voracious toads feed on insects and crowd out native species. Where poisoning, hunting, freezing, and whacking have failed, gene drive might succeed. One idea would be to drive a gene that makes the toads die when they’re exposed to an otherwise-harmless compound. Gene drive might similarly eliminate other invasive species, including the zebra mussels clogging the Great Lakes, the Asian carp driving native species out of America’s waterways, and the pythons that have obliterated raccoons and rabbits in Florida’s Everglades.While that may sound ecologically worthwhile, intervening in nature seldom goes as planned. For one thing, these invasive species are also established species, said environmental biologist Todd Kuiken of the Woodrow Wilson Center. “I don’t think we have a good way to evaluate what happens if we remove a species from a system as large as” the Great Lakes, let alone Australia, he said.Nor do scientists know what else, besides what they intend, gene drive might affect in the wild. Genes don’t necessarily stay put. Through a process called horizontal transfer, they can jump from one organism to another, even an unrelated species. A gene drive that kills cane toads could jump to a benign creature. A gene drive that prevents locusts from swarming, benefitting farmers, might jump to bees, threatening their ability to pollinate and produce honey. “We need to understand what would happen if gene drive transferred into other species,” Kuiken said.Perhaps the greatest worry is a reiteration of Esvelt’s “who are these guys?” experience. With the rise of do-it-yourself biologists operating outside institutions, it’s anyone’s guess what they’re doing.MIT’s Oye, for instance, raises the “most extreme scenario” of bioterrorists altering the genomes of disease-causing organisms to make them more lethal or more infectious, and using gene drives to spread that trait throughout a population.“I’m not saying that any decent, sensible human being would want to do it,” Oye said, “but it is possible.” About the Author Reprints Experts debate: Are we playing with fire when we edit human genes? By Sharon Begley Nov. 17, 2015 Reprints [email protected] As soon as Harvard biologist Kevin Esvelt began reading the scientific paper, he had a desperate question: Who are these guys? The authors had used a controversial new molecular technique to try to force a certain gene to be inherited by all of a fruit fly’s offspring. Confounding a basic principle of genetics, they had succeeded. Nearly every one of the young flies carried the gene, for yellow pigmentation. While turning a bunch of flies yellow may sound innocuous, “gene drives” — as biologists call the cellular machinery that guarantees inheritance — have enormous potential promise as well as risks. Because gene drives could rapidly propagate novel DNA through an entire population in the wild, they could be used, proponents say, to eradicate marauders such as the cane toads overrunning Australia. They might make mosquitoes resistant to the microbes that cause malaria or dengue fever, or even block the gene that makes locusts swarm, saving millions of tons of crops every year. advertisement Related:last_img read more

Senators ask drug makers to explain prices for opioid overdose antidote

first_img “One concern is that money for naloxone is coming out of the same pot as money for treatment and prevention,” Alison Knopf, editor of Alcoholism & Drug Abuse Weekly. “The costlier it is, the less money for treatment and prevention.”Meanwhile, last February, Kaleo Pharma raised the list price for two single-dose injectors to $3,750, from $750, a price that was set last November, after previously costing $575, according to Truven.Collins and McCaskill also wrote the other companies that market versions of the drug, including Mylan Laboratories, Kaleo, Adapt Pharmaceuticals, and Pfizer, whose Hospira unit markets a form of the drug. They asked what the companies are doing to ensure access to their treatments. We asked each company for their reaction to the letter and will update you accordingly.[UPDATE: An Adapt spokesman wrote us that the price of its Narcan nasal spray version has remained steady at $125 for a carton of two doses, and a 40 percent discount is available to non-profits, community-based organizations, and first responders to buy two doses for $75.And a Kaleo spokesman sent us a note saying the company has a program that provides “little to no out-of-pocket costs” to patients and caregivers with  commercial insurance. We asked about actual costs, and will provide any reply. The company, he added, has also donated more than 150,000 doses of Evzio.] Medical students demand better training to tackle opioid crisis Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. About the Author Reprints @Pharmalot Related: In the latest attempt to combat prescription drug abuse, two US senators want several drug makers to explain their pricing for naloxone, a decades-old drug that is widely used to reverse the effect of opioid and heroin overdoses.The move comes amid ongoing reports that the cost of the treatment continues to rise, despite bitter complaints from public officials. At the same time, public health officials cite a growing number of overdose deaths — more than 27,000 were recorded in the US in 2014.In identical letters to five drug makers, Susan Collins, a Maine Republican, and Claire McCaskill, a Democrat from Missouri who chairs the Senate Special Committee on Aging, wrote that they are concerned that rising prices “may be limited access for emergency responders and public health departments.”advertisement Heroin, painkiller overdose antidote getting easier to buy By Ed Silverman June 7, 2016 Reprints Related:center_img But naloxone has received special attention, because the medicine is used to reverse the effects of opioids on the brain and can limit or stop a heroin or prescription opioid overdose. “It becomes critical in the field for a cop, a paramedic, or EMT worker,” said Dr. Lewis Nelson, an emergency medicine specialist at the New York University Langone Medical Center. “You could watch someone die without it.”advertisement The most common formulation used by police departments, hospitals, and addiction advocacy organizations is made by Amphastar Pharmaceuticals, which created a ruckus by raising the list price of 10 pre-filled, 2-milliliter syringes from $120 to $330 in October 2014, according to Truven Health Analytics. The list price for 10 fixed-needle syringes also rose from $169.50 to $330.Such price hikes sparked anger among state agencies and, shortly afterward, prompted Senator Bernie Sanders and Representative Elijah Cummings, a Maryland Democrat, to pressure Amphastar for pricing information. The company responded to the pressure, in part, by striking deals with some states to sell its drug at a reduced rate.Two months ago, for instance, Amphastar reached such an agreement with the Connecticut attorney general and, in January, renewed a similar yearlong agreement with the New York state attorney general. We asked Amphastar for comment and will pass along any reply. PharmalotSenators ask drug makers to explain prices for opioid overdose antidote Ed Silverman Two US senators want several drug makers to explain their pricing for naloxone. Toby Talbot/AP [email protected] Prescription drug pricing is a highly contentious issue, and McCaskill and Collins held closely watched hearings last year to examine huge price hikes taken by Valeant Pharmaceuticals and Turing Pharmaceuticals, which was run by Martin Shkreli. Tags heroinNaloxoneopioidslast_img read more

‘Biocurious’ about biotech? Here are 10 must-follow Twitter accounts

first_img Gaze into the abyss of biotech Twitter and you’ll find a bramble of obtuse acronyms, confusing abbreviations, and a weird propensity for using dollar signs as hashtags. But within that sprawl are some leading 140-character authors who provide all-important insight, clarity, and context to those hoping to understand the fast-growing industry of drug development.Sometimes they’re even funny.We’ve put together a list of 10 such illuminating feeds for the biocurious. Important note: We’ve left off the great many journalists you should probably be following already. We’ve also omitted some of the entrepreneurs and commentators who have thousands of followers as it is. That’s not a slight; we just figure those people are already on your radar.advertisement By Damian Garde and Meghana Keshavan Aug. 22, 2016 Reprints @damiangarde NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. Damian Garde @megkesh Alex Hogan/STAT Privacy Policy About the Authors Reprints The witty Brit: @maverickNYSally Church is a jolly nerd who tweets out incisive observations of the biotechnology industry, providing more detailed analysis on her useful, but pricey, Biotech Strategy Blog. The Novartis alum-turned-life science marketer is a fangirl of good science, but isn’t afraid to call out BS when she sees it — particularly when it comes to her field of expertise, oncology.The legal mind: @jsherkowPatents are important in biotech, as the latest multimillion-dollar fracas suggests. And Jacob Sherkow, a professor at New York Law School, is an expert in the field. Look to him for context on the latest squabbles over biosimilars, thoughts on the legal implications of data sharing, and tweetstorms about the future of CRISPR.The regulatory maven: @fdaadcommThe murky waters of regulatory policy are daunting for some — but not for Jessica Adams, who ardently tracks the goings-on of the Food and Drug Administration’s scientific advisory committees as part of her gig as a consultant for Tarius, a regulatory research outfit. Hers is a no-frills account that will keep you abreast of FDA’s long-winded but all-important priorities day to day — in 140 characters.The scientific nitpicker: @VinayPrasad82Let’s just all admit it: Biopharma data can be sliced and diced in a way that’s often overly flattering — particularly when it comes to survival rates for cancer. Dr. Vinay Prasad, a hematologist-oncologist in Oregon, uses his Twitter feed to cut through to the core of what’s presented in a clinical trial or academic paper. Don’t argue with him on progression-free survival. He’ll school you.The skeptic: @sciencescannerDavid Grainger, a partner at biotech investor Medicxi Ventures, is quick to raise a finger on the latest hype-fueled to-do in biotech. From his perch in the UK, he pokes holes in widely reported studies, dispels convenient myths about biotech, and bemoans the misleading jargon companies use to sway public opinion.The rockstar VC: @lifescivcIf only all life sciences venture capitalists were as transparent as Bruce Booth. A stalwart, really, of the biotech blogosphere, the Atlas Ventures VC (and “recovering scientist”) is a ready source of useful and current info on early-stage life science investment. On occasion, he punctuates his bioscience commentary with quotes from luminaries like Ansel Adams, Christopher Hitchens, and Metallica.The number cruncher: @maxjacobsedisonBiotech is a business, after all, and businesses are supposed to make money. But amid all the hype of unmet needs and futuristic science, many drug developers are quietly burning the candle at both ends. Maxim Jacobs, head of healthcare research at Edison, is a pro at digging through the mire of financial filings and asking key questions like, “Shouldn’t this company be bankrupt?”The individualist investor: @bradloncarPerched yonder in Kansas City, private investor Brad Loncar isn’t afraid to turn a skeptical and opinionated eye to the biotech industry. Notably, he’s built up a cancer immunotherapy index, and reliably tracks the performance of 30 large cap and growth biotechs in that space. In a former life, Loncar worked in politics.The contrarian: @zbiotechSpeaking of those anonymous investors, here’s one more. Zach, as he’s called on Twitter, is lightning-fast to tweet breaking news but does so with a heavy heap of sarcasm, skepticism, and disdain for the cloying optimism that sometimes flows from the mouths of biotech executives. [email protected] Meghana Keshavan Leave this field empty if you’re human: Instead, here are some interesting, if lesser-known, guideposts from biotech’s vibrant Twitter community.The mystery guru: @andybiotechThere are a great many anonymous investors on biotech Twitter, shouting up or down at various companies from the safety of their egg avatars. But none is like AndyBiotech, whoever he or she is. With a comprehensive grasp on the industry and its many players, Andy provides context for key data readouts, spots underreported news, and combs through documents for interesting tidbits.advertisement Biotech‘Biocurious’ about biotech? Here are 10 must-follow Twitter accounts Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. Please enter a valid email address. [email protected] Tags biotechlast_img read more

More US adults using marijuana as concerns about risk decline

first_imgColumbia University researchers reported similar results in June among teens, and the authors of the new paper noted that while shifts in perceived risk of marijuana use have long been known to predict trends in pot use among adolescents, no previous research had examined the relationship among adults.In a commentary accompanying the Lancet Psychiatry report, King’s College of London addiction researchers Michael Lynskey and Wayne Hall were cautious about tying the reduced perceptions of harm to the passage of laws in many states legalizing medical marijuana.“It is probably too soon to draw conclusions about the effects of these legal changes on rates of cannabis use and cannabis-related harms,” he wrote, “but it is likely that these policy changes will increase the prevalence and frequency of cannabis use and, potentially, cannabis use disorders in the longer term.” HealthMore US adults using marijuana as concerns about risk decline Privacy Policy Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. But the proportion of American adults who believe smoking marijuana once or twice a week is harmful decreased, from 50.4 percent to 33.3 percent, reported the researchers from the National Institute on Drug Abuse and the US Department of Health and Human Services. Related: Tags marijuanamedical marijuana By Leah Samuel Aug. 31, 2016 Reprintscenter_img Justin Sullivan/Getty Images “(A)dults have perceived less risk of harm from marijuana use since 2006–07,” wrote the researchers. “And these declining risk perceptions were associated with increases in marijuana use and frequency of use.”advertisement Please enter a valid email address. This is your brain on pot: Neuroscientist studies long-term effects of medical marijuana Marijuana use is losing some of its taboo among US adults, according to a new analysis of government survey data. In a report published in the journal Lancet Psychiatry Thursday, federal researchers conclude that pot use began increasing in about 2007, coinciding with a drop in the number of Americans who see the drug as harmful.Researchers studied data from nearly 600,000 adults aged 18 or older who took part in the annual US National Survey on Drug Use and Health (NSDUH) from 2002 to 2014. In 2002, 10.4 percent of respondents had used marijuana in the year prior to taking the survey. By 2014, that number rose to 13.3 percent — an increase of 10 million people.In the same period, the number of first-time marijuana users and the prevalence of daily or near-daily use also increased. advertisement Leave this field empty if you’re human: Despite the increase in marijuana use noted in the study, the researchers surprisingly found a decrease in marijuana abuse or dependence during the study period. But they noted that the number may be skewed by the fact that the study did not include people who were homeless and not living in shelters or incarcerated. These groups could increase numbers for disordered use of the drug.In any case, they wrote, “Future research on trends in marijuana abuse and dependence and their relationships with perceived risk could help elucidate reasons for the discrepancy between marijuana use patterns and use disorders.”last_img read more

The ‘Swiss Agent’: Long-forgotten research unearths new mystery about Lyme disease

first_img By Charles Piller Oct. 12, 2016 Reprints Leave this field empty if you’re human: In the lab during this period, Burgdorfer infected US ticks with the Swiss Agent, his lab books show. The records don’t state his experimental goal, but Rocky Mountain Lab scientists often studied which animals and arthropods could be infected with different agents, and thus might be reservoirs or vectors for disease. He also looked for Rickettsia in ticks in Lyme-endemic areas and found dozens of examples, but often neglected to determine the specific rickettsial species.In December 1981, just a few months after discovering the Lyme spirochete, he wrote to a Swiss colleague who was overseeing a young investigator’s defense of his PhD thesis concerning the Swiss Agent. Burgdorfer suggested this question: “Do you feel that ‘Rickettsia suisse’ is the etiologic agent of (Lyme)? If so, how would you go about proving this?”Burgdorfer and his colleagues reported their discovery of the cause of Lyme in the journal Science in 1982. In a handwritten draft found among Burgdorfer’s papers, he described identifying Rickettsia in Lyme patients’ sera and ticks, and his efforts to rule out Rickettsia as the cause of Lyme — without naming the Swiss Agent.But in the final Science article, he made no mention of Rickettsia. Not a word about possibly finding the Swiss Agent in this country has ever been published.Slides of the Swiss Agent from Burgdorfer’s files Ron Lindorf/Burgdorfer ArchivesFinishing the huntBurgdorfer retired in 1986 at age 60, just a few years after the successful Lyme hunt put him at the pinnacle of his field.“I started to realize that the research I used to do and was successful in doing has changed its character,” he explained to a National Institutes of Health biographer in 2001. “Molecular and genetic biology have replaced the technologies I was able to apply,” he said. “Since I had no basic training in these fields … I was unable to speak and understand the completely new language.”Those fluent in the “new language” of molecular biology and genetics will be able to finish Burgdorfer’s work, experts said. If the Swiss Agent is here, they can find it.The CDC’s Mead said his agency is using molecular techniques to look for evidence of bacteria in 30,000 sera samples from people suspected to have contracted tick-borne illnesses. If Rickettsia helvetica is in some of the samples, it probably will be found, he said. That process will taken several more years to complete.Dr. W. Ian Lipkin, who directs the Center for Infection and Immunity at Columbia University, is hunting for viruses as well as bacteria living in ticks that spread Lyme, partly to understand why antibiotics sometimes fail in apparent Lyme cases.Lipkin’s group has collected 5,000 ticks from New York and Connecticut. With funding from the Steven and Alexandra Cohen Foundation, he has so far identified 20 new viruses in these ticks, and is exploring whether they have caused harmful infections in people, using tests that can search for a wide range of tick pathogens in a single sera sample. Eventually, Lipkin said, this process could make the tests affordable on a mass scale.“Everyone wants to get to the bottom of this,” Lipkin said. “All of this is critical to … finding out why some people respond to antibiotics and some people don’t, and whether or not the antibiotics being used are appropriate, and trying to find ways to link different bacteria and different viruses to different syndromes.”Lipkin is seeking funds to expand the work to tick-borne bacteria, including Rickettsia.Asked whether his methods could find evidence of infections with the Swiss Agent, Lipkin replied without hesitation. “The answer is yes,” he said. “If this particular rickettsial species is present, I’m sure we will see it.”Negatives of microscopic images of the Swiss Agent, from Burgdorfer’s archive Kris Newby/National Archives and Records Administration archivesWilly’s last wordsAfter he retired, Burgdorfer sent most of his voluminous personal files to the National Archives in Washington, D.C., where they were cataloged for public viewing. Those records contained some Swiss Agent documents. Many more lay untouched for decades in his garage and home office in Hamilton, Mont.Late in life, Burgdorfer developed Parkinson’s disease and became increasingly infirm. A friend listened to his fears that his garage files might be lost to history. She urged Burgdorfer to contact Ron Lindorf, then an entrepreneur and business professor at Brigham Young University, who had been suggested by colleagues.Early one morning in June 2014, an agitated Burgdorfer called Lindorf with an urgent request: “Come to Montana and get all my research, my files. I want to put it on the internet so people can see it,” Lindorf recalled him saying. Ticks often carry more than one pathogen, so patients can also have co-infections along with Lyme, which frequently begin with similar symptoms, such as fever, neck stiffness, and headaches.“You can’t tell them apart clinically” in the first several weeks, Steere said. Co-infections can cause “more severe early disease … a phenomenon of the summer, when the tick bites.” Longer term, the confusion would not last because of Lyme’s distinct symptoms, even if the infection were untreated, he added.Other experts noted that Lyme and Rickettsia helvetica have co-infected patients in Europe. Antibiotics normally cure Rickettsia helvetica infections, but diagnosis can prove difficult because the microbe does not cause a rash. If untreated or inadequately treated, the two infections share overlapping, serious, and sometimes persistent symptoms, according to clinical researchers. These include debilitating fatigue, severe headaches, muscle weakness, meningitis, facial paralysis, and sarcoidosis — a chronic inflammatory disease that can cause lung and skin problems. Numerous studies have linked Rickettsia helvetica to such ailments, although it is not regarded as a major public health peril in Europe.Andrew Main, who conducted Lyme research at Yale University in collaboration with Steere and Burgdorfer, had Lyme early on, before its cause was discovered, and was among patients who showed evidence of co-infection with the Swiss Agent — a result that was included in Burgdorfer’s papers but that Main knew nothing about until informed by STAT. The positive tests for the Swiss Agent among Lyme patients back then, he said, strongly support the idea that it might be a current threat.Robert Lane, a University of California, Berkeley, medical entomologist and Lyme expert who worked closely with Burgdorfer, is respected by both sides in the Lyme wars. He said Rickettsia helvetica could be a significant hidden factor that worsens Lyme infections and makes them harder to cure.“You would want to look at it both ways. Could that organism, if present in some of the Lyme-disease endemic areas, infect people and cause clinical illness on its own, or react in concert with (the microbe that causes Lyme) or some of the other agents,” Lane said. “If you are looking for one or a few agents in a tick, you may be overlooking others that contribute to the disease burden.” Please enter a valid email address. Privacy Policy And scientists who worked with Burgdorfer, and reviewed key portions of the documents at STAT’s request, said the bacteria might still be sickening an unknown number of Americans today.While the evidence is hardly conclusive, patients and doctors might be mistaking under-the-radar Swiss Agent infections for Lyme, the infectious disease specialists said. Or the bacteria could be co-infecting some Lyme patients, exacerbating symptoms and complicating their treatment — and even stoking a bitter debate about whether Lyme often becomes a persistent and serious illness.Swiss Agent, now called Rickettsia helvetica, is likely not a major health risk in the United States, in part because such bacteria typically respond to antibiotics. Still, several of Burgdorfer’s former colleagues called for infectious disease researchers to mount a search for the bacterium.advertisement A disease detective hunts pathogens with a photographic memory — and a genius mind Please enter a valid email address. The tick hunter was hopeful he had found the cause of the disabling illness, recently named Lyme disease, that was spreading anxiety through leafy communities east of New York City. At a government lab in Montana, Willy Burgdorfer typed a letter to a colleague, reporting that blood from Lyme patients showed “very strong reactions” on a test for an obscure, tick-borne bacterium. He called it the “Swiss Agent.”But further studies raised doubts about whether he had the right culprit, and 18 months later, in 1981, Burgdorfer instead pinned Lyme on another microbe. The Swiss Agent test results were forgotten.Now STAT has obtained those documents, including some discovered in boxes of Burgdorfer’s personal papers found in his garage after his death in 2014. The papers — including letters to collaborators, lab records, and blood test results — indicate that the Swiss Agent was infecting people in Connecticut and Long Island in the late 1970s.advertisement Leave this field empty if you’re human: He rose to lead the work on Rickettsia, rod-shaped bacteria spread by ticks that cause ailments such as Rocky Mountain Spotted Fever — which is sometimes deadly for patients in New England as well as the West. Burgdorfer built a global reputation for his knowledge of Rickettsia and Borrelia — corkscrew-shaped “spirochete” bacteria of the same group as the species known for causing syphilis.On a trip back to Switzerland in 1978, Burgdorfer and a few colleagues discovered in local ticks the previously unknown Swiss Agent — later named Rickettsia helvetica (from Switzerland’s ancient Latin name, Helvetia). He found the microbe infectious for meadow voles — a small rodent common in Europe and the United States — and deadly to chicken embryos. No one knew then that it also caused illnesses in people.Burgdorfer returned with samples of infected ticks and Swiss Agent antigen, molecules from the bacterium that can provoke an immune response, for further study. When mixed with blood sera — a part of the blood that doesn’t contain blood cells — the antigen can show whether a person has been infected.By then, Steere, a young Yale professor, had for several years been aggressively investigating why some of his patients in Lyme, Conn., were reporting serious and strange symptoms of an apparently new illness. He had found “that many patients suffered not only of arthritis, but also of disorders affecting the skin, muscular, cardiac, and nervous systems,” Burgdorfer told his official biographer from the National Institutes of Health in 2001.Steere asked Burgdorfer to join the hunt for a tick-borne microbe believed to be at the heart of Lyme. He sent samples of his patients’ blood sera to Rocky Mountain Laboratories for analysis.Blood sera from Lyme patients showed infection with the Swiss Agent. Results of 64 or greater were considered firm evidence, as this test showed for 6 of 11 patients. The test showed no infections with other Rickettsia. Alex Hogan/STATSera tests showed that at least a dozen Lyme patients had been infected with Swiss Agent, and that at least six others might have been infected. The records did not make clear how many Lyme patients had been tested overall. Burgdorfer told Steere and other colleagues that the results pointed to a potential cause of Lyme.Steere sensed a breakthrough. “I am excited to pursue further the possibility of a rickettsial etiology of Lyme disease,” he wrote to another researcher.Burgdorfer was encouraged, in part, because of the test’s specificity: A positive result strongly suggested that the person had been infected with the Swiss Agent and not a different Rickettsia such as the one that causes Rocky Mountain Spotted Fever.But when a second test method showed inconsistencies, doubts crept in about whether Swiss Agent was linked to Lyme. About 18 months later, Burgdorfer broke through, providing a rare undisputed fact in what would become the most disputatious of diseases: A spirochete causes Lyme. Years later, the microbe was named in his honor, Borrelia burgdorferi.But he hadn’t given up on Swiss Agent completely. Related: Persistent Lyme disease symptoms aren’t helped by long-term antibiotics STAT was approached with Burgdorfer’s archives by Kris Newby, who is writing a biography of Burgdorfer and produced an award-winning documentary that sympathetically depicts Lyme patients and doctors who challenged the medical establishment over its approach to Lyme diagnosis and treatment.The documents offer a tantalizing glimpse into how disease detectives tracked down Lyme’s cause — and how potentially significant loose ends can sometimes be dropped by researchers pressed for time and funding or diverted by more promising leads.Note written by Burgdorfer Burgdorfer ArchivesThey show that Burgdorfer intended to look more deeply into the Swiss Agent, which he had discovered in 1978 in Switzerland, but never did. His former colleagues speculate that he set aside this research to focus on identifying the cause of Lyme. When the Swiss Agent turned out to be an unlikely candidate after all, he redeployed his limited time and resources to other prospects.But the papers suggest that he might have gone to his grave harboring regret that he didn’t follow up on the Swiss Agent findings, as reasonable as the decision was, Benach said.On the top of a stack of documents in his garage was a mysterious note, penned boldly in red ink in the scientist’s unmistakable handwriting. “I wondered why somebody didn’t do something,” it said. “Then I realized that I am somebody.”The Lyme warsLyme has now become one of the most common infectious diseases in the United States — it’s been found in every state except Hawaii, and is rampant in the Northeast and parts of the Midwest. The CDC estimates that 329,000 people are infected annually.Lyme has also provoked what’s often described as a “war” over diagnosis and treatment. If Rickettsia helvetica is in the United States, some experts consulted by STAT said, unrecognized infections might be one of several factors contributing to the controversy, by creating confusion over the cause of some patients’ illnesses.The Infectious Diseases Society of America, the CDC, and many doctors view Lyme as generally easy to diagnose with its characteristic “bulls-eye” rash and pinpoint lab tests, and easy to cure with two-to-four weeks of antibiotics. If the disease is not diagnosed and treated early — in up to 30 percent of cases, there is no rash — patients can develop longer-lasting and more serious symptoms. But most infectious disease doctors say a short course of antibiotics will cure those patients.But an insurgency of renegade doctors and patients disagrees. They argue that the diagnosis is frequently missed because of poor lab tests and other factors, and that Lyme becomes a chronic condition when untreated or inadequately treated. The patients describe symptoms that include incapacitating “brain fog” and weakness, intense anxiety, severe muscle pain, and paralyzing headaches. Many say that they required treatment with antibiotics lasting months or longer to be cured after years of misery.Although the few small clinical trials that have examined long-term antibiotic therapy up to 90 days have shown few if any clear benefits, this camp has gained a passionate following, including a cadre of researchers who publish papers supporting this alternative view, and a medical group — the International Lyme and Associated Diseases Society.The medical establishment mostly views “chronic Lyme” as the product of quack doctors exploiting desperate patients by offering unproven therapies. The patients sometimes need psychiatric care, these experts say, but in any case, chronic physical complaints are not caused by an active Lyme infection. Some state medical boards have gone so far as to revoke licenses of doctors who prescribe long-term antibiotics.Dr. Allen Steere, then a professor at Yale who first identified Lyme disease in patients, was excited about initial lab tests that strongly suggested that the Swiss Agent was Lyme’s cause. Alex Hogan/STATBurgdorfer in his lab. Burgdorfer ArchivesIt’s hard to overstate the animosity that characterizes this clash. A few angry patients have compared establishment Lyme experts — including Dr. Allen Steere, who collaborated with Burgdorfer and has received death threats — to the Nazi doctor Joseph Mengele.How might the Swiss Agent add fuel to this conflict? Steere, a Massachusetts General Hospital researcher and among the world’s leading Lyme experts, said some patients who believe they have Lyme, but who test negative for the infection, might be suffering from an illness caused by one of several other microbes. Rickettsia helvetica could be among them, he said. Lindorf was not a professional archivist, but agreed: His children had suffered from serious bouts of Lyme disease, he was eager to help the scientist who discovered Lyme’s cause, and he had the ability to take on the complex job. The next month Lindorf arrived in Hamilton, departing two days later with his SUV packed full of old files. That November, Burgdorfer died.To better understand the Burgdorfer archive, Lindorf began collaborating with Newby, producer of “Under Our Skin,” the Lyme documentary. She shared the documents with STAT, hoping that an independent report would illuminate a possibly hidden risk for Lyme patients and others.Lindorf returned to Montana last year to visit Burgdorfer’s second wife. She pointed across the garage to some additional boxes. Inside a cardboard portfolio covered in flowery fabric and closed by a metal clasp, he found more of the Swiss Agent archives, topped by Burgdorfer’s “I wondered why somebody didn’t do something” note.“It made the hairs on the back of my neck stick up,” Lindorf said. “It felt like Willy talking from the grave.” Privacy Policy Related: Special ReportThe ‘Swiss Agent’: Long-forgotten research unearths new mystery about Lyme disease Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Climate change is speeding the spread of Lyme disease Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. After initial tests, Burgdorfer suspected the Swiss Agent caused Lyme. He shared the strong evidence with a close colleague in Switzerland to see whether he could verify the findings in patients there. Alex Hogan/STAT“It should be done,” said Jorge Benach, a professor emeritus at Stony Brook University and a coauthor of Burgdorfer’s seminal 1982 paper describing the detection of the Lyme microbe. Public health concerns warrant a new study, Benach said, and with today’s more advanced “weaponry for pathogen discovery, it would make perfect sense.”Dr. Paul Mead, chief of epidemiology and surveillance for the Centers for Disease Control and Prevention’s Lyme disease program, said that he wasn’t familiar with Rickettsia helvetica, but that “new tick-borne pathogens could certainly be out there.” He cited several found in the years since Lyme’s cause was discovered. Any serious, common co-infection would usually, but not always, be noticed by physicians as a distinct problem in Lyme endemic areas, he said.In Europe and Asia, Rickettsia helvetica has been recognized as a relatively rare but sometimes serious health threat if untreated. It’s been linked to a handful of sudden deaths from heart disease, as well as facial palsy, deafness, meningitis, chronic muscle weakness, and temporary paralysis. But US laboratories don’t test for the Swiss Agent. Tags infectious diseaseLyme disease A page from Willy Burgdorfer’s archive shows elements of the research process he used to find infectious agents and study their properties. (English translation of the German: “Different Working Branches of Rocky Mountain Laboratories” ) Kris Newby/Burgdorfer Archives Ticks from Burgdorfer’s archives Ron Lindorf/Burgdorfer Archives Finding the Swiss AgentThe man who found Lyme’s cause devoted his career to studying creatures sometimes described as tiny living cesspools, for the infectious stew of microbes ticks carry and transmit while sucking blood from animals or people.While training for his PhD in his native Basel, Switzerland, Burgdorfer became a preeminent “tick surgeon,” as he called himself — dissecting thousands with eye scalpels and Swiss watchmaker forceps. In 1951 he became a research fellow at the federal Rocky Mountain Laboratories, a remote outpost in Montana’s breathtaking Bitterroot Valley that specializes in infectious agents.Burgdorfer fell in love with the Bitterroot and with Gertrude Dale See — a secretary and technician at the lab. She won the multilingual scientist’s heart with her ability to speak French. They married and had two sons, and Burgdorfer became a US citizen and permanent lab employee. Related:last_img read more

Key FDA official who fought to uphold agency standards to retire

first_img Andrew Harnik/AP PharmalotKey FDA official who fought to uphold agency standards to retire Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. “He’s been very important to the entire drug review process. He’s run a good ship and has been a key part of creating a productive regulatory climate,” said Ramsey Baghdadi, co-founder of Prevision Policy, a health care consulting firm that closely tracks the FDA. “He’s the model of what you want in a government official – a high-integrity person. It’s a big loss and industry will view it that way, too.”advertisement Leave this field empty if you’re human: By going public with his exhortations, Jenkins was signaling that drug makers should not attempt to cut corners, a concern among consumer groups and others have complained may occur in the wake of the Sarepta approval.“Jenkins has been part of the new, forward-looking FDA and modernized the thinking there,” said Ira Loss of Washington Analysis, a consulting firm that tracks regulatory doings and the pharmaceutical industry. “He was an honest broker and you could see that in his presentation. He was part of an overwhelming group who didn’t agree with Woodcock and felt an obligation to speak up publicly.” Newsletters Sign up for Pharmalot Your daily update on the drug industry. His Jan. 6 departure will occur as the FDA is expected to come under increasing pressure to relax procedures for approving new medicines and allowing companies to more liberally market their treatments to physicians. In fact, Congress is expected to vote on Tuesday on a bill, known as the 21st Century Cures Act, which is designed, in part, to speed product approvals. Tags drug developmentpharmaceuticalspolicy House approves the 21st Century Cures Act, sending landmark bill to Senate Privacy Policy Dr. John Jenkins, a key official at the US Food and Drug Administration known for striking a delicate balance between agency standards and industry interests, will retire next month.Jenkins has worked for the agency for much of the past 25 years, most recently as the director of the Office of New Drugs, where he has been responsible for overseeing a rising number of drug approvals. In 2015, for instance, the agency endorsed 45 novel new medicines, an output that has been rising in recent years even as industry applications remained fairly steady, according to an FDA report.“He has brought the Center for Drug Evaluation and Review’s drug review process, known worldwide as the model of excellence, to where it is today,” said Dr. Janet Woodcock, who heads the CDER division and supervised Jenkins, in a statement. For now, Woodcock will assume his responsibilities while a national search for a replacement gets under way.advertisement By Ed Silverman Dec. 5, 2016 Reprints About the Author Reprints @Pharmalot [email protected] Please enter a valid email address. Although Jenkins largely played a behind-the-scenes role, his views were, indeed, crucial in helping shape countless agency decisions. And he unexpectedly gained notoriety two months ago by warning companies not to mimic the approach taken by Sarepta Therapeutics to win regulatory approval of a drug for Duchenne muscular dystrophy.The agency’s endorsement was seen as a litmus test for agency approval of new medicines, notably for diseases with unmet medical needs, as parents and lawmakers pressed the FDA to green-light the drug. The episode was marked by unusual bickering inside the agency over clinical trial data and, moreover, is now prompting vociferous debate over whether the FDA lowered its approval standards.Speaking at an industry conference, Jenkins offered a slide show about what he called “lessons learned” from the Sarepta episode, and essentially outlined regulatory do’s and don’ts for drug makers to follow. The company failed to heed agency suggestions to expand a small clinical trial, among other issues, and one high-ranking FDA official filed a dispute over the Woodcock’s insistence on approving the drug. Ed Silverman Related:last_img read more

Missing appointments? Skipping doses? You might get fired by your doctor

first_imgWhat happened? Among the reasons the nearly 800 practices surveyed gave for cutting ties with a patient:Violent, “disruptive,” or inappropriate behavior toward doctors or staffViolation of policies related to chronic pain and controlled substancesFailure to show up to scheduled appointmentsRepeated disregard of a doctor’s medical recommendationsViolation of bill payment policiesO’Malley said some of these reasons are “perfectly legitimate reasons to dismiss a patient.” She said that “a dearth of literature” exists on the subject of patient dismissals. But as more doctors rely on value-based reimbursements, patient dismissals could still rise.The reasons behind patient dismissals can be controversial, too. For instance, many pediatricians have treated children whose parents are opposed to vaccinations. As the anti-vaccine movement has grown, the American Academy of Pediatrics last year said that doctors may dismiss such patients as a last resort so long as they provide information about finding a new doctor and provide emergency care in the short term. APStock The study’s authors say it could happen, but they’re not seeing that yet.“The reasons practices are dismissing patients aren’t so much related to the things people were worrying about — that if [insurers reimburse more for] quality of care, doctors might start cherry-picking patients,”  said Dr. Ann O’Malley, Mathematica Policy Research senior fellow and lead author.advertisement By Max Blau May 15, 2017 Reprints Email Have you fired a patient? Have you been fired by your doctor? Tell us below.center_img A new survey of primary care doctors reveals an interesting statistic: 9 out of 10 practices have told a patient not to come back.The doctors have fired their patients.The research, published in JAMA Internal Medicine on Monday, found that firing patients doesn’t happen often, but it’s making some health experts nervous that doctors will expunge difficult patients from their rolls as insurers move toward reimbursing them more for benchmarked health outcomes than actual services provided.advertisement HealthMissing appointments? Skipping doses? You might get fired by your doctor Name Privacy Policy Tags patientsphysiciansresearchlast_img read more

This insulin maker is running out of money. Its solution? Reality TV

first_img 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. “Reversed” cast members sign a “contract” promising to stick to healthy habits for managing their diabetes. Alissa Ambrose/STAT By Rebecca Robbins June 5, 2017 Reprints MONTEGO BAY, Jamaica — The drug manufacturer MannKind has been burning through millions of dollars each month. It only has 3,000 patients taking its sole product, an inhalable form of insulin. It recently said it doesn’t have enough cash to get to the end of this year.So why, then, is the company sponsoring a reality TV show filmed here in this tropical resort town? 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. This insulin maker is running out of money. Its solution? Reality TV Business Log In | Learn More Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What’s included? What is it? GET STARTED Tags diabetesfinancepatientspharmaceuticalswellnesslast_img read more

Minority communities will be hit hardest by soaring rates of Alzheimer’s disease

first_img Related: By David Satcher and William A. Vega June 14, 2017 Reprints Compared to whites, African-Americans are twice as likely and Latinos 1.5 times as likely to develop Alzheimer’s. A recent report by the University of Southern California Roybal Institute on Aging and LatinosAgainstAlzheimer’s found that the number of Latinos in the U.S. living with Alzheimer’s disease is projected to increase by 832 percent by 2060. David Satcher [email protected] First OpinionMinority communities will be hit hardest by soaring rates of Alzheimer’s disease Even though Alzheimer’s is more common among Latinos and African-Americans, they are less likely to be diagnosed with the disease in a timely fashion than whites. That steals valuable time to plan care. Further, Latino and African-American families are less likely to recognize the symptoms and signs of Alzheimer’s and dementia than whites, punctuating the need for increased promotion of brain health and research engagement within these growing communities.advertisement William A. Vega It’s time to stop side-stepping the obvious: In addition to affecting the lives of virtually all Americans in the coming years, Alzheimer’s disease will devastate communities of color. We must act with urgency and coordinated force today to prevent that from happening.According to new data from the Centers for Disease Control and Prevention, Alzheimer’s deaths increased by 55 percent among all Americans between 1999 and 2014. But they increased 99 percent for African-Americans and 107 percent for Latinos. While striking, that’s likely to be an underestimate because some independent studies have found that Alzheimer’s deaths are underreported on death certificates by approximately six times because death is often attributed to more immediate causes, like pneumonia.The CDC’s data highlight the acute challenges this disease poses for African-American and Latino communities, where this ever-worsening brain disease is growing disproportionately and where personal resources for fighting it are inadequate. In these communities, trust in medical institutions has been eroded by racism, low standards of care, and unjust past medical research practices.advertisement @USCRoybal Gender gap in Alzheimer’s disease rates, caregiving needs more attention The federal Administration on Aging has estimated that, by 2030, minorities will make up close to 30 percent of the older adult population in the United States — a trend that could be devastating for a growing number of Latino and African American families, as the likelihood of developing Alzheimer’s doubles about every five years after age 65. As our society ages and becomes increasingly multiethnic, addressing Alzheimer’s across all racial and ethnic groups must be a public health priority for state and federal governments.The CDC’s data also illuminate the impact that Alzheimer’s is placing on families and caregivers. According to the CDC, “Significant increases in Alzheimer’s deaths, coupled with an increase in the number of persons with Alzheimer’s dying at home, have likely added to the burden on family members or other unpaid caregivers.” That’s putting it mildly.In 2016, informal caregivers provided over 18 billion hours of unpaid care for individuals living with Alzheimer’s or dementia, at an economic value of more than $230 billion. African-American and Latino caregivers have reported spending more time providing intensive care for loved ones compared to their white or Asian American peers.We must work across federal agencies and independent organizations to address this crisis as we did with the polio epidemic in the 1950s, HIV/AIDS in the 1980s, and, more recently, diseases like Ebola and Zika.Any national effort must be adequately resourced to match the tremendous challenge that Alzheimer’s represents for our communities and our economy. Our national investment in Alzheimer’s research and programming totals less than 1 percent of the $259 billion we spend on the disease in direct and indirect costs annually, with more than half of that borne by Medicare and Medicaid. For comparison, the United States appropriates nearly $5.4 billion to the National Cancer Institute for cancer research, even though Medicare and Medicaid costs are consistently higher for individuals living with dementia than with cancer or heart disease.Alzheimer’s costs, which may rise to $1.1 trillion by 2050, have the potential to bankrupt our economy. This financial burden is made even worse by the emotional toll Alzheimer’s takes on families. According to national advocate Daisy Duarte, who cares for her mother with early-onset Alzheimer’s, “Alzheimer’s is devastating and certainly not something we planned for financially or emotionally.”Thanks to bipartisan leadership, Congress passed a budget for fiscal year 2017 that included nearly $1.4 billion for Alzheimer’s research, a 40 percent increase from the previous year. While historic, that fell short of the $2 billion in annual funding that leading researchers say is needed to achieve the national goal of stopping Alzheimer’s by 2025. But the Trump administration’s budget request for fiscal year 2018 would cut NIH funding by nearly $8 billion, make deep cuts to prevention funding at the CDC, and eliminate vital initiatives at the Department of Health and Human Services aimed at increasing the diversity of the medical workforce, all of which would seriously hamper advances in Alzheimer’s disease.This shortsighted view of public health will allow Alzheimer’s to thrive in the shadows, claiming lives and precious federal dollars that could be fueling innovations in workforce development, health, and education. We must take heed of the CDC’s latest data and address the Alzheimer’s crisis by increasing investments in Alzheimer’s breakthrough research and care support in 2018 and beyond. It’s essential that these efforts include a focus on addressing disparities in brain health affecting Latino and African-American families — a smart move for the economy and our public health.David Satcher, MD, is a former U.S. surgeon general and the founding director of the Satcher Health Leadership Institute at the Morehouse School of Medicine in Atlanta. William A. Vega, PhD, is the executive director of the Edward R. Roybal Institute on Aging at the University of Southern California Suzanne Dworak-Peck School of Social Work. Both authors are board members of UsAgainstAlzheimer’s. About the Authors Reprints A patient paints during the Memories in the Making art program, an exclusive program of the Alzheimer’s Association. Bill Ross/AP Tags agingdementiaend of lifeneurologylast_img read more

FDA is urged to withdraw ‘ultra’ high-dose opioids over risks

first_img GET STARTED By Ed Silverman Aug. 31, 2017 Reprints What is it? Pharmalot @Pharmalot FDA is urged to withdraw ‘ultra’ high-dose opioids over risks 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 Reprints APStock What’s included?center_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED [email protected] In the latest bid to combat the opioid crisis, several groups representing public health officials, physicians, and safety advocates are urging the Food and Drug Administration to remove “ultra” high-dose opioids from the market, arguing that the risks outweigh the benefits.In making their case, the groups point to research showing that a person who takes high dosages has a risk of developing an opioid use disorder that is 122 times greater than someone who has not been prescribed opioids, while a person taking a relatively low dose is 15 times as likely to develop a disorder. Tags addictionpharmaceuticalsSTAT+ Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. 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 Ed Silvermanlast_img read more