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

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

FDA advisory panel endorses Pfizer/BioNTech Covid-19 vaccine

first_imgHealthFDA advisory panel endorses Pfizer/BioNTech Covid-19 vaccine After an early lunch, Pfizer will make a presentation on the vaccine. Then the FDA will make a presentation, which will lay out for committee members what issues the agency wants their advice on and what questions it wants them to answer by holding votes.Then, starting at 3:10 p.m. EST (or thereabouts), the committee members will begin their deliberations. That’s crunch time.— Helen BranswellThe contextThe Covid-19 pandemic is raging around the world but most especially in the United States, which has the highest number of cases and deaths of any country on the planet. More than 15.3 million Americans have been diagnosed with Covid-19 and more than 288,000 have died.The country has invested billions of dollars into fast-tracking development and production of Covid vaccines through a military-led project called Operation Warp Speed. While vaccines have been developed at an exceptional pace, there’s been a steady decline in the estimates of how quickly Americans will be vaccinated. Operation Warp Speed currently estimates it will have enough vaccine for 20 million people by the end of December — though vaccines in warehouses and vaccines in arms are two different things.The administration now estimates that every American who wants to be vaccinated will be able to access vaccine by the end of the second quarter of 2021. Thursday’s hearing starts that process.— Helen Branswell [email protected] A panel of outside experts on Thursday recommended the Food and Drug Administration issue an emergency use authorization to the Covid-19 vaccine being developed by Pfizer and BioNTech, a vaccine that appeared to be highly efficacious in a Phase 3 clinical trial.The 17-4 vote came after a long day in which members of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, discussed a wide range of issues related to the vaccine, including concerns about vaccinating people with severe allergies and 16- and 17-year-olds, as well as issues regarding vaccination during pregnancy or lactation.Although the FDA does not have to follow the panel’s recommendation, it is widely expected to do so.advertisement ‘How are we going to get on that plane?’: The transatlantic race to deliver CAR-T cancer therapy during the pandemic ‘How are we going to get on that plane?’: The transatlantic race to deliver CAR-T cancer therapy during the pandemic Tags Coronavirusvaccine Adobe Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Related: The rollout of Covid-19 vaccine could then begin in the United States in a matter of days.STAT’s coverage of the meeting is below, with updates and analysis posted in reverse chronological order.advertisement Leave this field empty if you’re human: A positive vote, but a missed opportunity6:30 p.m.: By any account, today’s vote — again, 17 yes, four no, with one abstention — was a resounding thumbs up for granting an emergency use authorization for the Covid-19 vaccine developed by Pfizer and BioNTech.But to anyone who has followed many FDA advisory meetings, the conclusion of this one was surprising, and not in a good way. The final vote seems to have been influenced by one narrow issue: the inclusion of 16- and 17-year olds in the proposed emergency use authorization. Oddly, the FDA declined to reword the question — something the FDA has done in the past during in-person advisory committee meetings — when some panelists protested the inclusion of people younger than 18. We don’t really know why the panelists voted as they did, though. Surprisingly, there was no opportunity for them to explain their vote afterward. Such comments are often every bit as important as the actual vote.The purpose of these committees — and of waiting for them — is to delve into nuance.  On that score, too many opportunities were missed.— Matthew HerperCoda: We need to talk about the kids6:20 p.m.: A late afternoon dust up over teenagers may at least partially explain four negative votes and one abstention when VRBPAC members voted on the question of whether the FDA should issue an EUA to allow use of Pfizer’s vaccine in people ages 16 and older.Several members of the committee expressed serious concerns about including 16- and 17-year-olds in the EUA, saying Pfizer has very little data on the vaccine’s safety in this group. The data package the company filed for its EUA application included only 153 participants 16 and 17 years old. (More recently the company has been vaccinating children as young as 12 years of age, but those data weren’t in the EUA filing.)“I would support not including them,” Hayley Gans, a professor of pediatrics at Stanford University, said during a section of the overall discussion where multiple members of the committee raised concerns about including that group.Multiple, but not all.“We have clear evidence of a benefit. All we have on the other side is theoretical risk,” said Paul Offit, a pediatrician at Children’s Hospital of Philadelphia.Acting chairman Arnold Monto, a vaccines researcher from the University of Michigan, called on FDA’s Marion Gruber, director of the Office of Vaccines Research and Review, for advice. She said she wanted to hear from the rest of the committee, so Monto called the vote.Several of the committee members — Gans among them — who had advocated excluding 16- and 17-year-olds ended up voting to recommend approval of vaccine. One, Cody Meissner, a pediatrician at Tufts Children’s Hospital, abstained. There was no call for an explanation of why dissenters voted no — and STAT hasn’t had time yet to reach out to them — but at least one, Archana Chatterjee, vice president for medical affairs at Rosalind Franklin University, had indicated she would have voted to raise the age covered by an EUA to 18 years old.— Helen BranswellThe vote5:37 p.m.: After eight-plus hours of data presentations, discussion and debate, today’s Covid vaccine advisory panel finally got down to voting on the penultimate question:Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?The results:17 Yes, 4 No, 1 abstention.And with that, the FDA will very likely grant an emergency use authorization to the Pfizer/BioNTech Covid vaccine within days, if not sooner.One thing to watch: There was a lot of disagreement among the panel members about whether the data support the inclusion of people 16-17 years of age in the EUA. Will FDA make changes to the EUA to exclude this group?— Adam FeuersteinPfizer pushes back against “crossover” design for placebo patients5:05 p.m.: Earlier in the day, there was an enthusiastic presentation of a proposal that tried to allow volunteers who had received placebo to receive the vaccine while minimizing the problems this would present for collecting new data about the vaccine.The idea, summarized by Helen this morning, is that all volunteers would get two more shots. Those who had received placebo would get the vaccine; those who got the vaccine would get placebo.But William Gruber, a Pfizer senior vice president, pushed back on this idea. It was, he pointed out, potentially impractical. “44,000 individuals would have to be brought in for two additional visits,” he noted. That means they would need to sign new consent forms. And, if they already suspected they received the vaccine because they noticed aches or chills, they might decide not to come in for those additional visits. Gruber has said previously that he is worried that volunteers will leave the study if they are not offered the vaccine, and that he will not get data from them at all.In an email earlier today, a Pfizer spokesperson confirmed the company is not currently planning to use the crossover design.“The participants in our COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic,” Pfizer said in a statement. “We also believe that we have an ethical duty to create a pathway within the study for interested, eligible participants in the placebo group to have access to the vaccine as regulatory authorities make decisions about authorization or approval of the vaccine candidate around the world.”Pfizer added: “In turn, we have developed a protocol amendment that is subject to input from and alignment with regulatory authorities but is designed so that all interested participants 16 years and older in the placebo group would have the option to receive the vaccine at scheduled timepoints in the study.”— Matthew HerperWhat do we do about vaccinating people with severe allergies? 4:29 pm: A big question has emerged around the Pfizer-BioNTech vaccine: Two people in the U.K who received the vaccine had severe allergic reactions requiring treatment, leading regulators there to advise that people with severe allergies should not get the vaccine for the time being.Paul Offit, the noted vaccinologist from Children’s Hospital of Philadelphia and a panelist at today’s meeting, pointed out that this is a potentially big problem. It means that tens of millions of Americans, by his count, could be too afraid to get the vaccine because they have a medical history of severe allergy. Offit was clear that he did not think this should stand in the way of an EUA, but he said that Pfizer and BioNTech needed to do a study in people with a history of common allergies and asked the FDA what it planned to do.“This issue is not going to die until we have better data,” Offit said.Marion Gruber, director of the office of vaccines research and review at the FDA, said that the FDA had note of this possibility even before the two cases in the U.K. Weeks ago, she said, language was added to a draft EUA warning that people who had an allergy to any of the vaccine’s components should not get it, and that equipment for dealing with a severe allergic reaction should be available wherever the vaccine is administered.Gruber also said that an independent analysis by the FDA had pointed to the possibility of some volunteers in the trial potentially having allergic reactions that researchers had not caught, although all of those would have been minor, by definition.But Offit pointed out that with this vaccine, which he said had one of the longest chemical names he’d ever seen, patients would have trouble identifying potential allergens from the ingredients list. He also clarified that his main worry, perhaps caused by years of discussions with people who were vaccine hesitant, was as much about people’s fears as the vaccine’s characteristics.“I’m talking about perception more than reality,” Offit said. “With those two statements out there, that people with severe allergic reactions shouldn’t get the vaccine, we just really need to offer people some solace.”— Matthew HerperShowtime!3:50 p.m.: The meeting, which is currently running about 40 minutes behind schedule, is about to get down to brass tacks.The session in which members will discuss what they’ve heard and vote on whether the FDA should issue an emergency use authorization for Pfizer’s Covid vaccine begins now.If you want to check the meeting out yourself, it’s streaming here.— Helen BranswellDuring Pfizer presentation, anxiety and excitement commingle2:55 p.m.: In a sense, Pfizer’s presentation to the VRBPAC was a victory lap, as Kathrin Jansen, the company’s head of vaccine research, took a moment to explain how an mRNA vaccine mimics the body’s normal immune response. A piece of mRNA is shepherded into a cell by a coating of fat, called a lipid nanoparticle. It does not, likely, get all the way to the nucleus, where the DNA is, so the mRNA is unlikely to ever have a long-term effect. But it makes a protein that is part of the virus, without any risk of viral infection.Amid all the science, though, Jansen emphasized that vaccines may be “the only way to return to normal lives.”The presentation conveyed both the tremendous potential and the impressive results that Pfizer and its partner BioNTech have demonstrated so far and some nagging questions. One of these has to do with whether the vaccine prevents severe cases of Covid-19 or hospitalizations. Pfizer simply has fewer of these severe cases in its trial than does Moderna, which is presenting results at an FDA panel meeting in a week. And one case logged as severe disease was in the vaccine group.center_img How many vaccine EUAs can the FDA grant?9:50 a.m.: Here’s an interesting question: If the FDA approves one Covid-19 vaccine, would that make it impossible to grant emergency use authorizations to future ones?Panelist Jeannette Lee, a biostatistician from the University of Arkansas, raised the issue after an FDA official outlined the rules governing EUAs. Among them is a provision saying that an EUA is warranted when there’s no adequate, approved product for a particular indication. When it comes to Covid-19, wouldn’t that suggest that once the FDA grants full approval to a first vaccine, it would be precluded from bestowing EUAs on the ones to come?The answer is no, according to Doran Fink, deputy director of the FDA’s vaccine division. If an approved product is available only in limited supply — as is certain to be the case with the first approved Covid-19 vaccine — the FDA can still grant EUAs to investigational products.That means that we’ll be tuning into meetings like this on a regular basis for the months to come. But, if the U.S. meets its goals of securing hundreds of millions of vaccine doses by the summer, it also means that the next generation of Covid-19 vaccines might have to go through the FDA’s standard, non-EUA process.— Damian GardeNEJM editorial: Vaccine is a ‘triumph’9:30 a.m.: As today’s FDA panel gets underway, one of the invited experts — and a voting member of the panel — has already expressed his opinion that the Pfizer/BioNTech Covid vaccine is a “triumph.”Eric Rubin, an immunologist at the Harvard T.H. Chan School of Public Health, co-authored a laudatory editorial about the vaccine, published this morning in the New England Journal of Medicine. While highlighting minor issues with the clinical trial design, the vaccine results are “impressive enough to hold up in any conceivable analysis,” Rubin wrote.He adds:“This is a triumph. Most vaccines have taken decades to develop, but this one is likely to move from conception to large-scale implementation within a year. The sequence of the virus that led to the development of the specific antiviral RNA sequence required to design the vaccine didn’t become known until it had been determined and widely disseminated by the Chinese Center for Disease Control and Prevention in January 2020. There is a lot of credit to go around: to the scientists who shared data and who developed the underlying methods and implemented them to create a vaccine, to the clinical trialists who performed high-quality work in the setting of a health emergency, to the thousands of participants who volunteered to take part in the trial, and to the governments that helped create performance standards and a market for the vaccine. And all this stands as a template for the many other Covid-19 vaccines currently in development, some of which have already completed their phase 3 trials.”The Phase 3 trial results from Pfizer/BioNTech were also published in NEJM this morning.— Adam FeuersteinHere we go!9 a.m.: The meeting has just been called to order. It is streaming here, if you are interested in checking in.The virtual audience for this meeting is expected to be large, and global. The world is watching how U.S. agencies are evaluating the effectiveness and safety of Covid-19 vaccines and how it’s thinking about prioritizing vaccine allocation.How do we know? Well, nearly 32,000 computers in more than 66 countries and most parts of the United States were streaming the Dec. 1 meeting of the Advisory Committee on Immunization Practices, an expert panel that helps the Centers for Disease Control and Prevention assess vaccines and prioritize their use. It is not common that an ACIP meeting would garner that much attention.During that meeting, ACIP members voted to recommend health care workers and residents of nursing homes get first access to Covid vaccines when supplies are limited.The VRBPAC audience will likely be larger. The FDA is considered the gold standard for regulatory agencies. It is the only one that requires companies applying to bring a drug or vaccine to market to supply its raw data, which the agency’s scientists recalculate to ensure that the claims being made by the drug or vaccine sponsor are supported by the evidence.Pro tip: If you’re wondering how long after today’s meeting it will take for FDA to decide on Pfizer’s emergency use authorization application, this afternoon’s discussion will be critical. Norman Baylor, a former director of FDA’s office of vaccines research and review, said Wednesday that if it seems like the committee members agree with the positive tone of the FDA’s review of the vaccine and vote unanimously to recommend an EUA be granted, things could move very rapidly.If however, VRBPAC members — who have been poring over the Pfizer data in preparation for the meeting — raise a bunch of red flags, there could be delays, said Baylor, who is now president and CEO of Biologics Consulting.— Helen BranswellThe FDA’s questions — and the placebo problem8:45 a.m.: The FDA has posted the questions that the panel will be charged with discussing. The big one, the voting question, is no surprise: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?”It would be a big surprise if the panel doesn’t vote positively, although I’d expect discussion about the meaning of each “yes.” In addition to the voting question, there are two discussion questions:1. “Please discuss any gaps in plans described today and in the briefing documents for further evaluation of vaccine safety and effectiveness in populations who receive the Pfizer-BioNTech Vaccine under an EUA.” 2. “Pfizer has proposed a plan for continuation of blinded, placebo-controlled follow-up in ongoing trials if the vaccine were made available under EUA. Please discuss Pfizer’s plan, including how loss of blinded, placebo-controlled follow-up in ongoing trials should be addressed.”I want to focus a bit on the second. This is going to be a big issue for all of the vaccine studies. Volunteers in these clinical trials generally expect that even if they were randomly assigned to get the placebo, they’ll be switched to the vaccine once it is effective.  Experts, in particular the ones on the VRBPAC panel, generally want to hold off the moment when placebo patients get the vaccine for as long as possible. Once it comes, the ability to compare the vaccine to a placebo to determine efficacy and side effects is lost.But there’s another problem, which is that once a vaccine is available, patients may try to get it outside the trial, which is even worse from the perspective of getting good data than switching them over. A month ago STAT obtained a Pfizer memo saying that the company’s plan was to switch patients over as soon as they were eligible to receive the vaccine. There will be a lot more discussion of that plan all day, with time specifically allotted to this issue at 10:50.— Matthew HerperVRBPAC’s agenda6 a.m.: Good day, folks. In honor of what promises to be an historic day, a crowd of us here at STAT— Matt, Adam, Damian and I — will be monitoring and live-blogging on the day’s discussions.For starters, let’s introduce you to the committee members. The FDA has a very strict conflict of interest policy for VRBPAC members. Anyone involved in any of the Covid-19 clinical trials — even a member who works at a university that is a trial site — is “conflicted out,” which means that temporary replacements who are equally stringently vetted are named in their place.The early part of the meeting, which begins at 9 a.m. EST, is about setting the table for the discussion that will follow. It includes discussion of what is happening in the U.S. outbreak right now, the plans for monitoring for adverse events potentially triggered by vaccination, as well as a presentation on distribution.At or about 10:50 a.m. EST (VRBPAC discussions can run long) there will be an important discussion about what steps can be taken to ensure that issuing EUAs for some vaccines don’t interfere with the efforts to run placebo-controlled trials on others that are behind them in the pipeline. This is a thorny but critical issue. Trending Now: Please enter a valid email address. By STAT staff Dec. 10, 2020 Reprints Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson STAT staff William Gruber, the Pfizer executive who presented the company’s data, described lots of alternative ways of cutting these data aimed at calming any nerves. First, he noted, this one case only counted as severe for one reason — a brief drop in blood oxygen levels. And, using different definitions of severe disease from the one favored by the FDA, there were more cases in the placebo group and they did worse.But at least one panelist seemed to have a different question: Do we even need to use two doses? Juan Gea-Banacloche, a Mayo Clinic epidemiologist, asked how confident Pfizer is that the second dose is even needed. Pfizer replied, basically, that there isn’t enough evidence to conclude a vaccine would give the same long-term protection as two doses.Pfizer also leaked out some news related to when we’ll have answers to some important vaccine questions. Data on how well the vaccine protects against asymptomatic infection — that is, Covid-19 cases with no symptoms — is expected early next year. And, as Helen noted earlier, preclinical studies aimed at understanding potential development toxicities could deliver preliminary results in mid-December, which could mean within days.— Matthew HerperSome news on vaccination during pregnancy or lactation1:55 p.m.: As Covid-19 vaccine rollout nears, a key question has been: Should pregnant and lactating people be vaccinated? There are no data on which to base an answer, but some may be on the way.The FDA told vaccine manufacturers they had to do what are called DART studies — that’s short for developmental and reproductive toxicity studies — before they could conduct clinical trials to test if these vaccines are safe to use in pregnancy and during breastfeeding. DART studies are done in animals, looking to see if there are any signs a vaccine might hurt a developing fetus or pose a threat to the pregnancy.None of the vaccine manufacturers near the front of the vaccine pipeline has completed DART studies. But on Thursday, Pfizer told the VRBPAC meeting it expects preliminary results from its DART studies in Wistar rats by mid-December — in other words, within days.The company will still have to do trials in people who are pregnant and lactating before the FDA would agree to specifically authorize the vaccine for these populations. But experts on the issue of drug and vaccine testing during pregnancy have urged the agency not to close the door to use in these groups in the meantime. In an opinion piece published Wednesday in STAT, they argued that the FDA should allow the vaccine to be offered to pregnant and lactating people, and let them decide whether they want to be vaccinated.Vaccination in the United States could begin within days, and health care workers are at the front of the line. About 75% of health care workers are women and a large portion of them are of child-bearing age. The CDC estimates that at any given time, about 330,000 health care workers are either pregnant or lactating.— Helen BranswellPublic hearing elevates vaccine hesitancy issue1:45 pm: Vaccine hesitancy was on full display during the one-hour open public hearing, as multiple speakers raised concerns about the safety of the Pfizer/BioNTech vaccine and the legitimacy of granting early authorization based on limited data.The skeptical comments, some of which veered uncomfortably close to dangerous conspiracy theories, underscore the challenge facing vaccine makers and public health officials in convincing Americans to get vaccinated against Covid-19.One speaker, who described herself as a mother of a child who she said was “injured” by routine childhood vaccinations, urged the FDA to disclose all the ingredients that go into the Covid vaccine, including “aborted fetal cells” — a false claim.Another speaker, a pediatrician from Florida who said he does not require his patients to get routine vaccines, highlighted potential safety risks that some people might experience if they get vaccinated.Several other speakers voiced concerns that the clinical trial conducted by Pfizer and BioNTech was rushed, or that certain participant groups, particularly people of color, were underrepresented in the clinical database. The 44,000-patient clinical trial enrolled a diverse patient population in terms of race and ethnicity, age, and underlying health conditions. About 26% of participants were identified as Latino and 10% as Black, with the study evenly split between men and women.To be clear, these panels are not meant to be coronations of clinical data without anyone asking appropriately probing questions. But these days, distinguishing healthy skepticism from damaging anti-vaccine tropes is increasingly difficult. The FDA wants to encourage transparency in the review process to enhance vaccine confidence, but by doing so, it also opens up the possibility of amplifying people with the opposite agenda.Sidney Wolfe, founder and senior advisor of Public Citizen’s Health Research Group, gave testimony during the open public hearing, expressing his support for the emergency use authorization of the Pfizer/BioNTech Covid vaccine. Wolfe is notorious for opposing almost every new drug that comes in front of the FDA, so his support shows that even perma-skeptics can be convinced that vaccine makers are doing something right.— Adam FeuersteinTrying to solve a sticky wicket12:15 p.m.: The morning’s session concluded with a fascinating presentation on a really tricky topic.A major dilemma facing the FDA has been the question of whether participants in the placebo arms of vaccine trials ought to be offered vaccine when an EUA is issued.Some of the manufacturers — notably Pfizer — want to give their placebo recipients vaccine. The FDA wants the trials to generate as much placebo-controlled data for as long as possible, because once the placebo groups are unblinded and vaccinated, important opportunities to collect data are lost forever.The VRBPAC panel heard an interesting compromise proposal at the end of the morning session from Steven Goodman, associate dean of clinical and translational research at the Stanford University School of Medicine.Goodman said ethically, the companies are not required to vaccinate the people in their placebo arms, though from a practical point of view, they could lose participants anyway when people in the trial become eligible to be vaccinated. And he said that vaccinating all placebo recipients after the issuance of an EUA would allow trial volunteers to “jump the queue” — get vaccinated before other people of their age or risk group.The proposed compromise would be to vaccinate placebo recipients, but maintain the blinding. What that would mean would be that when people in a trial were eligible to get vaccine where they lived, they would be vaccinated. If someone had received placebo shots originally, they’d be given vaccine. If someone had received vaccine doses, they’d get placebo shots. They would not be told what their original status was — but all would be confident that they had received vaccine.“As soon as they can get it outside their trial than this would kick in,” Goodman said. “I don’t think we have that special obligation to give them the vaccine early.”This approach would remove the motivation for people who are in trials to withdraw as vaccine starts to roll out across the country, he said. And while vaccinating the placebo arm would result in some loss of data — for instance, the ability to continue to compare safety data long term — it would allow the trials to continue to gather comparative data on issues like the durability of the immune response generated by the vaccine.On the question of whether placebo-controlled vaccine trials can continue once one vaccine has received an EUA, Goodman said in times of limited vaccine supplies it would still be ethical, but might become increasingly infeasible as supplies increase and more and more people have access to vaccines.— Helen BranswellHow do you monitor a vaccine’s safety and efficacy after it is authorized?11 a.m.: The big question when a vaccine is tested in 30,000 people and then given to 30 (or 300?) million is how one knows if it is as safe and effective as it initially appeared.Part of the answer is to conduct more clinical trials, but it’s also necessary to conduct observational studies that can capture how well the vaccine is working in the real world. The plans for doing this were presented by Nancy Messonnier of the Centers for Disease Control and Prevention, who became well known for her prescient public remarks early in the pandemic.On safety: the CDC is stitching together a number of large databases that will allow it to track adverse events and try to determine if those are side effects of the vaccine. These include the Vaccine Adverse Events Reporting System, run by the CDC and the FDA, but also other databases including the CDC’s V-safe and VSD databases, and databases from the Department of Veterans Affairs, Department of Defense, and Genesis Healthcare, a database in long-term care facilities run with Brown University.And how do you track efficacy without a clinical trial? That will be done in much the same way that the efficacy of flu vaccines is tracked, by comparing whether people who test positive for Covid-19 got the vaccine at a different rate than those who test negative. This will start with a study among healthcare workers to check that the vaccine’s overall efficacy is what is currently expected, followed by studies in severely affected or hospitalized patients, the elderly and those in long-term care facilities, and those with key underlying conditions, among other groups. Messonnier said that U.S. safety monitoring will be coordinated with international efforts to do the same, including those of the World Health Organization.— Matthew Herper Privacy Policy About the Author Reprints Related:last_img read more

Farmers Yet to Receive Year-End Distribution

first_img RELATED ARTICLESMORE FROM AUTHOR Facebook Twitter News NewsEconomy North Korea has emphasized its significant growth inagricultural output thanks to the bunjo [cooperative farm productionunit] system, but the workers from these farms have yet to receive theiryear-end distribution, Daily NK has learned.“It’s because the managing committee of the cooperativefarms have been handing in portions that should be distributed to farmers tothe military,” a source based in North Hamkyung Province told the Daily NK onMonday.Year-end distribution usually takes place on each farm afterharvesting and threshing of the crops has been completed. After excludingproduction, maintenance, operation costs, and rice for the military from thefarm’s output, any surplus is distributed among the farm workers.However, due to measures that require farms to guaranteerice for the military as their top priority, the distribution that should havecome to a close in December is still underway. This exacerbates an alreadysubpar harvest and faulty policies that have seen farmers receive less thantheir fare share this harvest. “Because of the drought last year, corn and overallproduction don’t even come to half of the harvest for 2013,”the source explained. “Military rice procurement that should have beenfinalized by the end of November has yet to come to an end.”Because of this, roughly a dozen soldiers congregate aroundcooperative farms every day to receive rice donations and place more pressureon farmers to step up production.“These soldiers have even forced the leader of bunjo units to goaround people’s homes, either threatening them to give up hidden grains orsearch their residence,” he explained as reason behind why some farmers havelost their stocks.Cooperative farms receive guidelines from the State PlanningCommission and Ministry of Agriculture outlining the amount of military riceallotted to them. In turn, the farms must guarantee this supply, prioritizingit above all else. Each year an estimated 70 percent of total production isdonated as military rice or state rice, according to the source.“Some of the farms have been worried about makingpreparations for production, thinking it may cause disruptions if all the riceis donated to the military, so they sometimes ask workers to hide crops intheir homes,” he said. “This is why it’s not uncommon to see conflicts betweensoldiers and farmers.”Beleaguered with anxiety, many have commented on theseeming futility of their labor, pointing out that “there’s no use in workinghard all year round since it’s the same as being forced into labor for free.”Others have expressed their concerns about losing corn that they grew in smallvegetable gardens before getting to eat any of it. Farmers Yet to Receive Year-End Distribution North Korea Market Price Update: June 8, 2021 (Rice and USD Exchange Rate Only) SHAREcenter_img By Choi Song Min – 2015.01.27 9:21pm AvatarChoi Song Min News US dollar and Chinese reminbi plummet against North Korean won once again News Proposal to shift “general markets” to “specialized markets” finds little support among N. Korean leaderslast_img read more

MIDA has Disbursed $1.71 Billion to Micro Business Sector

first_imgMIDA has Disbursed $1.71 Billion to Micro Business Sector UncategorizedJune 21, 2007 RelatedMIDA has Disbursed $1.71 Billion to Micro Business Sector RelatedMIDA has Disbursed $1.71 Billion to Micro Business Sector FacebookTwitterWhatsAppEmail The Micro Investment Development Agency (MIDA) has disbursed $1.71 billion in funding to approximately 23,000 micro businesses since its inception in 1991.Board Chairman of MIDA, Anthony Freckleton, speaking at the agency’s 15th anniversary celebration held yesterday (June 20) at the Terra Nova Hotel in Kingston, highlighted the work on the organization in the growth of the country’s micro business sector.He noted that 36,517 full and part-time employments have been created and sustained through the work of MIDA.Minister of Industry, Technology, Energy and Commerce, Phillip Paulwell, in his remarks, described the agency as “a tremendous organization”.“At 15 years of age, MIDA has indeed come of age. Established to provide a focused approach to the development of the micro enterprise sector, the agency, I believe, and I’m sure many will agree, has done a splendid job of providing the credit support necessary for the growth and sustainability of the sector,” he said.The programme of MIDA, he noted, mirrors the current focus of the Ministry on small business development. “We believe that small-scale businesses are the future industrial strength of the country. We are therefore placing great emphasis on encouraging micro, small and medium-sized entities in every possible manner through credit, through the availability of technology and business support,” he pointed out.Managing Director of the agency, Vivian Chin, said that in carrying out its mandate, MIDA, in 1993, established Community Development Funds (CDFs), in an effort to establish a clearly defined retail credit channel for delivering its loan funds to persons with the necessary pre-requisites and capabilities to start businesses, and those who wished to expand and sustain their ventures.Speaking on the performance of the agency during the 15 years, Mr. Chin said that to date, the CDFs have some $500 million in assets, serving approximately 5,500 micro-business operators, while delivering approximately $200 million in credit over the last three years to 1,800 customers.In addition, of the total number of loans granted, 55 per cent of these were given to women, while young people accounted for 31 per cent of the total numbers.Recounting the early years of the agency, Maureen Webber, President of Development Options Limited, expressed her pride in being one of the founders of MIDA. “We created an idea, gave birth to it, and today, despite our challenges, we see all the opportunities and we will continue to grow,” she said. MIDA was established in November 1991 with its principal objective of facilitating the development of the micro business sector in Jamaica through the extension of loans to the sector. The establishment of MIDA was a deliberate strategy taken by the government to create employment and reduce the level of poverty in the country.Interested persons can visit MIDA’s website at www.Jamaica-MIDA.com for further information on loans and the work of the CDFs.center_img RelatedMIDA has Disbursed $1.71 Billion to Micro Business Sector Advertisementslast_img read more

Hoonigan pits Porsche Taycan against world’s fastest C8 Corvette

first_imgTrending in Canada We encourage all readers to share their views on our articles using Facebook commenting Visit our FAQ page for more information. You’d expect the Launch Edition to include most of the option sheet – and you’d be right. All of them include the Level 2 Equipment Group, which adds the likes of carbon-fibre interior trim and a Harman-Kardon premium sound system, plus a dual-pane panoramic sunroof and some active driving aids. Specifically, VIN 001 also features optional equipment including rock rails, a bed-mounted tire carrier, and the trailer tow group which includes trailer reverse steering control. RELATED Pickup Review: 2021 Ram 1500 TRX See More Videos advertisement The Rolls-Royce Boat Tail may be the most expensive new car ever COMMENTSSHARE YOUR THOUGHTS PlayThe Rolls-Royce Boat Tail may be the most expensive new car everPlay3 common new car problems (and how to prevent them) | Maintenance Advice | Driving.caPlayFinal 5 Minivan Contenders | Driving.caPlay2021 Volvo XC90 Recharge | Ministry of Interior Affairs | Driving.caPlayThe 2022 Ford F-150 Lightning is a new take on Canada’s fave truck | Driving.caPlayBuying a used Toyota Tundra? Check these 5 things first | Used Truck Advice | Driving.caPlayCanada’s most efficient trucks in 2021 | Driving.caPlay3 ways to make night driving safer and more comfortable | Advice | Driving.caPlayDriving into the Future: Sustainability and Innovation in tomorrow’s cars | Driving.ca virtual panelPlayThese spy shots get us an early glimpse of some future models | Driving.ca First Look: 2022 Lexus NX The sport-cute’s looks have been softened, but its powertrains and infotainment offerings have been sharpened All proceeds from the sale went to benefit of the United Way for Southeastern Michigan, specifically the helpline that provides services to veterans and their families. Barrett-Jackson waived all fees associated with the sale. From Brawn to Tusk: Hennessey Mammoth is a 1000-hp Ram TRX ‹ Previous Next › RELATED TAGS1500RamPickup TruckFlexNews4x4auctionBarrett JacksonhellcatmuscletrxVIN 001 RAM has made a lot of noise – both literally and figuratively – with their 702 horsepower TRX off-road beast. Last weekend, VIN 001, the first of 702 Ram 1500 TRX Launch Edition models, sold at the Barrett-Jackson auction block in Scottsdale, Arizona.While the hi-po truck is being built in small quantities, the Launch Edition is rarer still. It shows up for duty in Anvil Gray exterior paint, exclusive to the Launch Edition, along with a with one-of-a-kind VIN 001 authentication kit. Think of the latter item as a guarantee the owner actually has the very first one.Which, it must be said, is a pretty big deal for collectors. Even though the truck itself differs not in terms of powertrain from the other 701 Launch Edition TRX pickups, a vehicle identification number from early in the build run is prized in certain circles. These ‘00001’ vehicles can make for a jewels in the collection of a high rolling gearhead. In addition, the entire run of Launch Edition trucks sold out in less than three hours when the model was announced, making this a rare opportunity for the moneyed set to pick up one that hasn’t been titled in someone else’s name. Trending Videoslast_img read more

Adobe Road Winery Retains Balzac Communications & Marketing

first_imgEmail Pinterest TAGSAdobe Road WineryBalzac Communications & Marketing Home Industry News Releases Adobe Road Winery Retains Balzac Communications & MarketingIndustry News ReleasesWine BusinessAdobe Road Winery Retains Balzac Communications & MarketingBy Press Release – February 13, 2017 81 0 Facebook Linkedin Share Twitter Previous article2016 California Winegrape Crush; Return to NormalcyNext articleWines of Canada Presents Spectacular Line-up at VIWF 2017 Press Release AdvertisementDynamic Founder of The Racer’s Group Applies Winning Strategy Crafting Exceptional Sonoma & Napa WinesFebruary 13, 2017 (Napa, CA) – Adobe Road Winery, the award-winning boutique winery founded in 2003 by champion race car driver Kevin Buckler of The Racer’s Group, has retained Balzac Communications & Marketing, the leading wine public relations and marketing agency, as their agency of record. The agency will promote the Adobe Road Winery brand to trade, media, and consumers.“Winners love winners, and we’re thrilled to be partnering with Balzac Communications & Marketing,” effuses Kevin Buckler, CEO of Adobe Road Winery. “With their extensive wine expertise and experience on board we are well positioned to promote our ultra-premium portfolio. Our Petaluma Tasting Room and our new winery project under construction on the Petaluma waterfront are outstanding showcases for these award-winning wines.”With a special focus on Sonoma and Napa vineyards, Adobe Road’s luxury small lot wines are produced by respected winemaker Garrett Martin. The crown jewel of the portfolio is the 2013 Beckstoffer Rutherford Cabernet Sauvignon, which received a 94-point rating from the Wine Spectator.“Whether you’re talking about racing or wine, Kevin’s passion for excellence is unparalleled, and his winning history is evident in the quality of the Adobe Road wines,” says Michael Wangbickler, CEO and Partner of Balzac Communications & Marketing. “Great wines combined with a passion for winning is the formula for success, and we’re looking forward to communicating the passion and excitement behind these winning wines.”In addition to several other Cabernet Sauvignons from Napa and Sonoma, Adobe Road Winery produces carefully crafted Cabernet Franc, Zinfandel, Syrah, Grenache, Red Blends, Pinot Noir, Malbec, Rosé, Viognier, Semillon and Chardonnay. The wines are available in select markets across the U.S., from the website, and in their Petaluma, California tasting room.About Adobe Road Winery – www.adoberoadwines.com:Kevin Buckler likes to build things. A successful entrepreneur and professional race car driver, Kevin is the owner and founder of The Racer’s Group (TRG), TRG-Aston Martin Racing and Adobe Road Winery. After a highly successful career in car racing as a driver and team owner, Kevin, along with his wife, Debra, founded Adobe Road Winery in 2003. He applies the same painstaking preparation and attention to detail used in his auto racing ventures to the meticulous crafting of small lot wines from Napa and Sonoma. With his wine team, he spends countless hours in the vineyard and the winery to create elegant, balanced wines with intense fruit and great regional character.About Balzac Communications & Marketing – www.balzac.com:Balzac Communications & Marketing is a marketing communications agency with a no-nonsense approach to combining the strategies and tactics of marketing, public relations, advertising and graphic design to achieve the marketing goals of its clients. The experience, creativity and determination of the staff distinguish Balzac from their competition. They use these assets to develop and execute cost-effective campaigns, which have won international communications awards. The results speak for themselves. The agency is located in Napa, California, and provides services to national, regional, and local companies based in Northern California and throughout the world.Advertisement ReddItlast_img read more

UPM Raflatac Announces Portfolio of FSC™ Certified Paper Face Stocks for…

first_imgLinkedin Advertisement6/12/2019 – UPM Raflatac, the world’s most sustainable labeling company, is pleased to announce a new range of FSC™ certified paper face stocks for the Americas market. This announcement takes UPM Raflatac one step closer to achieving its target of sourcing wood fiber from 100 percent certified sources by the year 2030.The new FSC certified products include paper wine label materials, semi-gloss, thermal transfer, direct thermal, and more. With more and more brands unveiling ambitious sustainability targets for their packaging materials, UPM Raflatac’s portfolio of FSC certified products can support them in achieving targets for sourcing paper products from certified sustainably managed forests.FSC certification by the Forest Stewardship Council™ is an internationally recognized mark of well-managed and sustainable forest operations. UPM Raflatac has supplied FSC certified products since 2008 and actively co-operates with the organization around the world. The aim is to increase the use of certified wood in the label production processes and to promote awareness of the forest certification and related responsibility issues.“Only about 10 percent of the world’s forests are certified today and much work remains to be done to promote responsible sourcing,” says Tyler Matuseveich, Sustainability Manager, Americas, UPM Raflatac. “UPM Raflatac is continuously striving to have the most sustainable label materials portfolio in the industry. In offering a new range of high quality face stocks on FSC certified papers for the Americas market, we can assure our customers we will always know the origin of fiber and can trace it back to the forest it came from. We invite you to partner with us to achieve your sustainability targets for sustainably sourced packaging materials.”Expanding the portfolio of FSC certified materials in the Americas is a significant milestone towards UPM Raflatac’s aim to supply products that are sustainable over their lifecycles, and to increase the range of eco-labeled products.For the full list of UPM Raflatac’s FSC certified (FSC™ C012530) paper label materials, please click here.For more information, please contact:Scott SowersSenior Communications Specialist, UPM RaflatacAdvertisement TAGSFSC™ certifiedUPM Raflatac Share ReddIt Pinterest Twitter Previous articleJean-Charles Boisset Introduces Napa Valley’s First Wine History Museum and Tasting Salon: 1881 NapaNext articleCentral Coast’s Miller Family Celebrates 20 Years of Grape Growing at Solomon Hills Vineyard Press Release Home Industry News Releases UPM Raflatac Announces Portfolio of FSC™ Certified Paper Face Stocks for Americas…Industry News ReleasesWine BusinessUPM Raflatac Announces Portfolio of FSC™ Certified Paper Face Stocks for Americas MarketBy Press Release – June 12, 2019 213 0 Email Facebooklast_img read more

US Gulf Coast Price an Appropriate Reference for Petrojam – Paulwell

first_imgUS Gulf Coast Price an Appropriate Reference for Petrojam – Paulwell TechnologyMarch 2, 2012 RelatedUS Gulf Coast Price an Appropriate Reference for Petrojam – Paulwell RelatedUS Gulf Coast Price an Appropriate Reference for Petrojam – Paulwell RelatedUS Gulf Coast Price an Appropriate Reference for Petrojam – Paulwell FacebookTwitterWhatsAppEmail Minister of Science, Technology, Energy and Mining, Hon. Phillip Paulwell has defended the use of the US Gulf Coast (USGC) Reference price system by Petrojam in the pricing of its products. Mr. Paulwell noted it has been suggested that the USGC reference price in the pricing formula should be replaced by Caribbean parity prices, on the premise that the Caribbean parity price would result in a decrease in gasoline and other product prices in Jamaica. “This argument reflects a fundamental misunderstanding of the oil market. In the same way that the U.S. dollar is accepted as the medium of exchange for most international transactions, the USGC reference price is accepted and used by all market participants in this region of the world to price their products,” the Energy Minister said. The Minister was responding to questions posed by Opposition Member of Parliament for St. Catherine North Eastern Mr. Gregory Mair in the House of Representatives on Wednesday (February 29). Mr. Paulwell further explained that the Caribbean Parity prices are themselves derived from USGC reference prices and are likely to be resisted by suppliers who would likely seek to protect themselves by imposing an additional price premium to reflect reduced liquidity and transparency. “Petrojam’s ex-refinery price is based on a logical arrangement that is indexed to international product prices, and incorporates taxes and business costs to arrive at the final product price. This approach has been demonstrated to provide the most realistic and fairest way of determining product prices and is widely used throughout the world,” the Energy Minister said. Petrojam’s ex-refinery prices are adjusted weekly to ensure that local prices are consistent with prices in the international oil market. The main input to the ex-refinery pricing formula is the USGC Reference price for the product such as gasoline.  The USGC Reference price represents the cost of the product in the largest geographical market of relevance to trades in the Caribbean/Central American/South American area. Other critical components of the ex-refinery price include logistics costs and Government of Jamaica Taxes, which vary with the price of oil. “The USGC is an appropriate pricing reference for several reasons including the size, transparency andliquidity of the market. Mexico, Venezuela and Trinidad, Petrojam’s main trading partners, also use the USGC prices to determine the value of their petroleum products,” Mr. Paulwell stated. By Latonya Linton, JIS Reporter Advertisementslast_img read more

Taoiseach and Micheál Martin to meet again next week

first_img 45 new social homes to be built in Dungloe The Taoiseach and the Fianna Fáil leader have agreed to meet again next week amid speculation an early general election is likely.Talks between Leo Varadkar and Micheál Martin last night were described as ‘constructive’ by both sides.The two leaders discussed proposed legislation that could be passed in the next Dáil session.Minister for Communications, Richard Bruton, says he’s happy to let people judge Fine Gael on their track record:Audio Playerhttp://www.highlandradio.com/wp-content/uploads/2020/01/bruton7am.mp300:0000:0000:00Use Up/Down Arrow keys to increase or decrease volume. Pinterest Today is the 30th anniversary of Eddie Fullerton’s murder Pinterest Google+ WhatsApp WhatsApp Donegal hoteliers enjoy morale boost as bookings increase Previous articleBorder Economic Stimulus Package workshop being held in DonegalNext article1 person killed in workplace related incident in Donegal last year News Highland Facebook By News Highland – January 10, 2020 center_img Google+ Facebook Disruption to cancer service will increase mortality – Oncologist Taoiseach and Micheál Martin to meet again next week AudioHomepage BannerNews Hospitalisations rise as Donnelly suggests masks will stay ’til autumn Consultation launched on proposal to limit HGV traffic in Clady RELATED ARTICLESMORE FROM AUTHOR Twitter Twitterlast_img read more