Oct 9, 2007 (CIDRAP News) – In quick succession, the view that influenza shots yield life-saving benefits for elderly people has come under serious attack and received fresh support in recent weeks.One group of experts, writing in the October issue of Lancet Infectious Diseases, argued that the mortality benefits of flu shots for the elderly have been greatly exaggerated because of a subtle bias and other methodologic problems in many of the relevant studies.”The remaining evidence base is currently insufficient to indicate the magnitude of the mortality benefit, if any, that elderly people derive from the vaccination programme,” says the analysis by Lone Simonsen, PhD, of George Washington University in Washington, DC, and colleagues.But in the Oct 4 New England Journal of Medicine (NEJM), another team of experts presented a study showing that in the course of up to 10 flu seasons, flu shots reduced the risk of hospitalization for pneumonia and flu by 27% and shrank the risk of death by 48% for elderly members of three health maintenance organizations (HMOs). The study addresses several of the methodologic problems raised by the Lancet authors.”Vaccine delivery to this high-priority group should be improved,” states the report by Kristin Nichol, MD, of the Minneapolis Veterans Affairs Medical Center and University of Minnesota, and four coauthors.The controversy has major policy implications, since the Centers for Disease Control and Prevention (CDC) and other medical groups heavily promote flu shots for elderly people, given their risk for serious complications if they contract the flu. This policy is reinforced by Medicare coverage of flu shots for this age-group.A sharp critique of the evidenceThe Lancet Infectious Diseases authors offer several reasons for questioning the notion that flu immunization saves lives in the elderly population:Vaccination coverage among the elderly has increased from 15% to 65% since 1980, but instead of declining, overall mortality due to pneumonia and influenza in elderly people has increased in that period.Few randomized, placebo-controlled trials have examined flu vaccine effectiveness in elderly people. The largest and best study, done in the Netherlands, showed a 50% reduction in confirmed flu cases among all the volunteers, but the reduction for those older than 70 was only 23%. There was no significant reduction in influenza-like illness.A number of investigators have reported finding evidence of flu vaccination benefits in the elderly by analyzing the records of large healthcare organizations. But these studies typically are flawed in that investigators looked for an effect on all-cause mortality, a nonspecific outcome, rather than on lab-confirmed flu. Further, many such studies may be marred by a subtle selection bias, wherein relatively healthy older people were more likely to be vaccinated than frail seniors were, thereby making vaccination look more beneficial than it really was. A further problem is that cohort studies typically have defined the flu season arbitrarily as December through March, rather than on the basis of flu surveillance.Simonsen and colleagues also write that since 1968, flu has accounted for an average of about 5% of all winter deaths in older people. Yet the results of cohort studies have prompted claims that flu vaccination reduces the risk of winter death from any cause by about 50% for community-dwelling people older than 65. “That influenza vaccination can prevent ten times as many deaths as the disease itself causes is not plausible,” say Simonsen et al.They argue that in view of the “slim” evidence that flu immunization prolongs elderly people’s lives, it may be time to consider doing more randomized, placebo-controlled trials—even though using a placebo would be “ethically unappealing.” In addition, they suggest, other options for protecting the elderly should be pursued, such as developing vaccines that are more immunogenic, using larger vaccine doses, and employing antiviral drugs more aggressively.Meanwhile, the researchers say elderly people should continue to be vaccinated, because “even a partly effective vaccine would be better than no vaccine at all.”Critiquing the critiqueThe review by Simonsen and colleagues drew praise in an editorial in The Lancet, written by two other vaccine experts who have reviewed the case for flu immunization in the elderly. Tom Jefferson and Carlo Di Pietrantonj of the Cochrane Vaccine Fields in Alessandria, Italy, write that Smonsen et al “prove that statistical methods for adjustment for residual bias used in the observational studies of influenza vaccines did not work, largely because of the difficulty of adjusting for frailty with data available in electronic records.”Jefferson and Di Pietrantonj endorse the idea of doing new randomized, placebo-controlled trials of flu vaccination in older people, arguing that such studies are “the only ethical and scientific way” to settle conclusively whether the vaccines are protective. The trials must cover more than one flu season and be large enough to detect rare outcomes, such as deaths due to flu, the pair assert.In an interview, a flu expert with the CDC asserted that the evidence of effectiveness remains strong enough to justify the US policy of promoting flu shots for the elderly. David K. Shay, MD, MPH, a medical officer in the CDC’s influenza division, agreed that better vaccines are needed, but he rejected the idea of doing placebo-controlled trials in the elderly as unethical.Shay said the randomized, controlled trial from the Netherlands that showed a 50% reduction in confirmed flu cases among the elderly provided “gold standard evidence” for a protective effect. The risk was reduced 57% in 60- to 69-year-olds versus 23% in those 70 and older, but because of wide confidence intervals, the difference between the two groups was not significant, he said.The Dutch findings and the high risk of flu-related hospitalization and death in the elderly provide the major underpinnings of the US policy of promoting flu vaccination in the elderly, Shay said, adding, “We’re left with the fact that this study [by Simonsen et al] isn’t going to change policy in the US for the use of these vaccines.”He said it is very difficult to demonstrate a reduction in mortality as a result of vaccination: “No vaccine trial ever done in the developed world has been [statistically] powered to look at a mortality benefit. So we’re going to have to rely on observational data.”As for the suggestion that unmeasured confounding variables have inflated the effectiveness of flu vaccines in observational studies, Shay said, “We also think that’s possible. The CDC is interested in working with HMOs to get a better handle on how to do vaccine effectiveness studies and mortality outcome studies.”But given the existing evidence that flu shots do help protect seniors, he rejected the suggestion of doing placebo-controlled trials. “If you can’t honestly answer, ‘I have no idea’ to the question whether the vaccine is effective, then you have no basis for doing a placebo-controlled trial,” he said.On the other hand, Shay commented, “Everybody would agree that we need a vaccine with greater effectiveness and greater immunogenicity in the elderly. Manufacturers are working on adjuvanted vaccines that hopefully will be more effective.”HMO study addresses methodologic issuesIn the NEJM study, Nichol and associates sought specifically to address the kinds of methodologic problems cited by Simonsen et al. They retrospectively gathered data on flu vaccination, hospitalization for pneumonia and flu, and death from any cause among community-dwelling elderly members of three HMOs. The study covered the flu seasons from 1990-91 through 1999-2000 for one HMO and those from 1996-97 through 1999-2000 for the other two. The HMOs were in Minnesota and Wisconsin, Washington state, and the New York City area.The study included 713,872 person-seasons of observation. Vaccinated subjects were slightly older and had slightly higher rates of most of the underlying medical conditions that were recorded. There were 4,599 hospitalizations for pneumonia or flu and 8,796 deaths.The per-season hospitalization rates for unvaccinated and vaccinated people were 0.7% and 0.6%, and the corresponding death rates were 1.6% and 1.0%. The figures translated into a 27% reduction in hospitalization rate for pneumonia and flu among the vaccinated (adjusted odds ratio, 0.73; 95% confidence interval [CI], 0.68 to 0.77) and a 48% reduction in mortality (adjusted odds ratio, 0.52; 95% CI, 0.50 to 0.55).The vaccine was somewhat less effective in preventing death—a 37% compared with 48% reduction—in the two seasons when the vaccine was a poor match for the circulating viral strains. For the seasons in which there was a good match, the vaccine yielded a 52% reduction in mortality risk.In an effort to detect any “healthy-vaccinee bias” (better underlying health among the vaccinated than the unvaccinated), the authors compared the risk of hospitalization among vaccinated and unvaccinated subjects during the summers (noninfluenza seasons) of 1999 and 2000. They found that the risks were similar for the two groups.The researchers went a step further by hypothesizing that an unmeasured confounding variable was influencing their findings and then estimating what that influence would be under various assumptions. They picked functional status as the unmeasured variable most likely to affect their subjects’ risk of hospitalization or death.On the basis of studies of functional status, the authors estimated that subjects with poor functional status would be half as likely to get a flu shot and two to three times as likely to be hospitalized or die, compared with those with better functional status. When they plugged these estimates into their data, along with estimates of the prevalence of the confounding variable, they found that the effectiveness of vaccination was reduced but still significant.For example, assuming that the confounder was present in 60% of subjects and that it doubled the risk of hospitalization or death, vaccination still reduced the risk of hospitalization by 14% and the risk of death by 39%. In the most extreme scenario—the confounder was prevalent in 60% and tripled the risk of hospitalization or death—vaccination still lowered the risk of hospitalization 7% and the risk of death 33%.The researchers write that their study “showed multiple benefits across multiple subgroups, a result suggesting that vaccination benefits probably extend to a broad spectrum of elderly persons.” However, they acknowledge that elderly HMO members may differ from elderly nonmembers, and the study did not include the frailest elderly, such as those living in nursing homes, who are likely to have weaker immune responses.A confidence boosterIn an accompanying NEJM editorial, John D. Treanor, MD, writes that the study by Nichol et al addresses many of the concerns raised about other observational studies “and increases our confidence in the benefits of influenza vaccination in older adults.”Because the evidence of vaccine effectiveness held up well through 10 seasons, the findings “convincingly dispel concerns that the previous studies were artifacts of a specific influenza season or a specific population,” states Treanor, who is a vaccine researcher; professor of medicine, microbiology, and immunology at the University of Rochester; and member of the CDC’s Advisory Committee on Immunization Practices.He also comments favorably on the authors’ efforts to address the concerns about unmeasured confounding variables, including the examination of summer hospitalization rates and the estimate of the effect of a hypothetical difference in functional status.”Overall, this study provides additional support for the current strategy to vaccinate elderly adults,” Treanor asserts. The methodologic issues are important, and the precise magnitude of the benefits of vaccination is not yet clear, but it is clear that vaccination is beneficial and should be used widely, he adds.However, he agrees with Shay that the development of more immunogenic and effective vaccines for the elderly is an important goal.Shay said the CDC is contemplating a special initiative to help resolve the controversy over the value of flu immunization for seniors. “Sometime in 2008 the CDC hopes to get together a panel of consultants to bring about ways to move forward and find ways to resolve this controversy,” he said. By assembling experts from the different camps, the agency hopes to come up with recommendations to guide the next series of studies, he said.Simonsen L, Taylor RJ, Viboud C, et al. Mortality benefits of influenza vaccination in elderly people: an ongoing controversy. Lancet Infect Dis 2007 Oct;7:658-66 [Abstract]Jefferson T, Di Pietrantonj C. Inactivated influenza vaccines in the elderly—are you sure? (Editorial) Lancet 2007 Oct 6;370(9594):1199-1200Nichol KL, Nordin JD, Nelson DB, et al. Effectiveness of influenza vaccine in the community-dwelling elderly. N Engl J Med 2007 Oct 4;357(14):1373-81 [Full text]Treanor JD. Influenza—the goal of control. (Editorial) N Engl J Med 2007 Oct 4;357(14):1439-41 [Full text]
It’s pretty safe to say that the one group of people that seem to be both overlooked and at the same time the vulnerable in the “war on piracy” are comedians. These entertainers need to create original content in order to stay relevant, and that content is a product of weeks of research and creative writing. When a comic takes the stage, what you are watching is the combined effort weeks of research, memorization, and delivery. If that person is lucky the work on that particular set will be usable for few months of live tours, and then possibly a DVD release.I follow more than a few comics across the various social networks, and every once in a while I see a burst of frustration when someone records their work on the first night of a new set and immediately uploads it to YouTube. Not only does it expose the performance to the rest of the world, but it does so in the quality of the average cell phone being held at a night club. When the one hour comedy set finally does get released to DVD, the production company releases it for $20 due to the expenses, like those that go in to securing the content to minimize further piracy. The end result of those security efforts can be seen on most piracy websites only hours after a DVD has been released, and now the comedy set is free to anyone who knows how to get it.It’s a tough scenario to be put in, and there’s not any real solution so long as you plan to continue releasing content in teh traditional means. If you really want to combat piracy, make the content just as easy to get, and don’t include any of the digital rights management nonsense. At least, that’s what the pirates say is necessary to keep most people from doing the deed. It’s a fairly significant gamble, but comedian Louis C.K. stepped up to call the bluff.In an extended note earlier this week Louis C.K. described his intent to release a comedy set that he had only just recorded, that had never been released on DVD. For $5, you would be able to stream the show two times, and download it three times. The show was made available in HD or SD (based on user preference), and the file was completely free of any digital rights management (DRM). The show would either sell or it would be quickly uploaded to every piracy site in the world and nobody would pay for it.This was a fairly significant gamble for Louis C.K., but one that sent a clear message calling out those who continue to justify piracy by saying that it is easier to get online in the format of their choosing. The second part of this gamble is testing exactly how much profit can be made from online sales versus DVD sales. This set, Live at the Beacon Theater, isn’t available in stores. The only place you can buy this comedy set is from his website, and there is no option to purchase a DVD.It did not take long for Louis C.K. to see results. In a new statement he released only four days later, C.K. explains that the video he sold cost him about $170,000 to make. The cost of making this video was largely offset by the tickets sold at the two sets he did at the Beacon, but for all intents and purposes he paid for the video to be produces out of his pocket. He further explains that the content in this show was exclusive, he had never used any of it in previous sets, or on his TV series.He continued to explain that he spent an additional $32,000 on having the website built to handle the load of customers downloading the movie or streaming it. Every effort was made to make the buying and watching experience as simple as possible. Not counting his time editing the video and testing the site, this gamble was already costing him over $200,000. Within 12 hours of the site going live on December 10th, over 50,000 copies had been sold, allowing him to break even on the costs so far. Under 72 hours later, the site had seen over 130,000 purchases.He noticed that this was still less than he would have made from a deal with a distribution company but this method helps the fans by giving them a more usable, more available file. Louis C.K. clearly feels that this was already a success, and more sales are coming in every minute. One thought from his statement that stuck with me was “You never have to join anything, and you never have to hear from us again.”The experiment was successful, but it remains to be seen whether or not this will have any actual impact on the industry. Even if more comedians take the same route as Louis C.K., there’s no real incentive for this to be implemented anywhere else. As he said, if he had left all of this to a production company he’d have made more money, spent less time, and wouldn’t have had to think about it twice. The content would have been pirated, and the circle would have continued.This was a significant proof of concept, in my opinion, that the process of releasing content without all of the mess in between can work, but it’s not likely to change how things work anytime soon.
India Plans Major Push for Storage, Boosting Renewables FacebookTwitterLinkedInEmailPrint分享The Hindu:The draft National Energy Storage Mission expects to kick-start grid-connected energy storage in India, set up a regulatory framework, and encourage indigenous manufacture of batteries, according to a member of the expert committee set up by the Ministry of New and Renewable Energy (MNRE) last month.The draft sets a “realistic target” of 15-20 gigawatt hours (GWh) of grid-connected storage within the next five years, according to Debi Prasad Dash, director, India Energy Storage Alliance (IESA), an industry body that is a part of the committee. Power grids do not currently use storage options that would help in smoothly integrating renewable energy sources.The draft has been submitted to the ministry, and will be released for public feedback in the next few months, said Dash. He added that the mission will focus on seven verticals: indigenous manufacturing; an assessment of technology and cost trends; a policy and regulatory framework; financing, business models and market creation; research and development; standards and testing; and grid planning for energy storage.Renewable energy sources now make up almost one-fifth of India’s total installed power capacity. However, as power grids increase their share of solar and wind energy, the problem remains that the peak supply of renewable sources does not always meet peak demand, explained P.C. Pant, a senior scientist with MNRE. For instance, solar energy generation may be at its peak at noon, but unless stored, it will not be available when needed to light up homes at night. Moreover, renewable sources are inherently intermittent: there are days when the wind doesn’t blow or the sky is cloudy.Batteries could help store surplus energy during peak generation times, but are more immediately needed to stabilize the grid when shifting between renewables and the baseload thermal capacity. “Once the installed capacity of renewables reaches 100 GW [from the current 65 GW], it will become critical to incorporate storage options,” said Pant.Solar Energy Corporation of India (SECI) expects to issue tenders for grid-connected storage by the end of the year, said its managing director Jatindra Nath Swain. For its own 160 MW plant in Andhra Pradesh, SECI will issue tenders for a storage option by the end of July, he added. “Up to 10% of [solar] power can be injected into the grid without storage,” he said. “After that, storage will become a necessity.”More: Draft Mission To Kick-Start Renewable Energy Storage
Braves’ Sean Newcomb has meltdown, sets off fire extinguisher after blown lead #Braves Claim OF Billy Hamilton off Waivers: pic.twitter.com/9nD3UUllsU— Atlanta Braves (@Braves) August 19, 2019Hamilton signed a one-year contract with the Royals this offseason. He hit .211 and stole 18 bases in 93 games with the team. Hamilton spent the first six years of his career with the Reds, where he batted .245 and swiped 50 or more bases in four straight seasons from 2014-17. Related News The Braves, meanwhile, placed outfielder Ender Inciarte on the injured list last weekend with a strained hamstring. He’s expected to miss four to six weeks. “I just want to do whatever it takes to fully be back to 100%,” Inciarte said after suffering the injury, via The Atlanta Journal-Constitution. “Right when I did it, I knew I was going to miss some time. I’m in pain right now. I’m just hoping it gets better soon.”Inciarte, who is slashing .246/.343/.397 with five home runs and 24 RBIs in 65 games in 2019, said he hopes to return before the end of the regular season, but that is far from a guarantee. The Braves have added depth in their outfield.Atlanta claimed speedster Billy Hamilton off waivers Monday, the team announced. The 28-year-old was designated for assignment by the Royals last week. Braves turn to Mark Melancon as closer Braves’ Ronald Acuna reacts to being pulled from game for not hustling It looks like Ender Inciarte suffered an injury scoring from second.Stay tuned. pic.twitter.com/ysnzYc3cog— FOX Sports: Braves (@FOXSportsBraves) August 16, 2019“We’re still going to play in October, and I want to be part of that,” Inciarte said. “In my mind, I’m thinking like that. … I have to be 100% positive that I’m coming back and that this team is going to be in a good position by then, and that we’re going to compete and do well in October because that’s the goal.”The Braves entered play Monday in first place of the National League East with a 74-52 record. They lead the Nationals by 5 1/2 games.