Treatment comes first in HHS antiviral guidance

first_img Risk of resistanceHHS also says that several comments focused on risks and uncertainties related to antiviral use, including the possibility of resistant viruses and adverse events. In addition, in response to a suggestion that families should be able to stockpile antivirals, HHS says that any recommendations on home stockpiling will depend on the results of pending studies. In the revised guidance, school dormitories may be considered a “closed setting for post-exposure prophylaxis during an outbreak,” if the students have not been dismissed HHS is buying antiviral drugs for the Strategic National Stockpile, and states are stockpiling the drugs with a 25% federal subsidy. The overall goal for public stockpiles is 81 million treatment courses, including 75 million courses for treatment and 6 million for containment and for delaying the spread of pandemic flu into the United States. Prophylaxis of high-risk healthcare and emergency services personnel for the duration of community pandemic outbreaks Roche and GlaxoSmithKline, the makers of oseltamivir and zanamivir, respectively, are developing home kits designed for stockpiling, HHS says. “Approval of these ‘medkits’ by the Food and Drug Administration will depend on studies showing that the kits can be appropriately maintained, the instructions understood, and the drug used appropriately at the correct time,” the agency says. “Any HHS guidance on home stockpiling will depend on the results of these studies and FDA approval of these products.” Containing or suppressing initial pandemic outbreaks overseas and in the United States with treatment and postexposure prophylaxis (PEP) among individuals identified as exposed to pandemic flu and for geographically targeted prophylaxis in areas where exposure may occur Reducing introduction of infection into the United States early in an influenza pandemic as part of a risk-based policy at US borders Like the draft version, the revised guidance says that antivirals for preventive treatment of healthcare workers and others will have to come mostly from supplies bought by private organizations and businesses for their employees. About 73 million courses are currently in federal and state stockpiles, according to HHS’s response to comments on the guidance. It also says “many federal agencies” are “acquiring additional stockpiles to support prophylaxis as recommended in the guidance,” but it does not list the amounts of these supplies. Dec 16, 2008 (CIDRAP News) – A revised federal guidance document on the use of antiviral drugs in an influenza pandemic reaffirms that public supplies of the drugs should be reserved mainly for treating the sick and that preventive treatment for high-risk workers should rely on private supplies. HHS also released a separate document summarizing the 28 comments it received on the draft version and presenting responses to them. At the same time, HHS released a revision of its guidance on employer stockpiling of antivirals, with no major changes. Despite the risks related to antiviral stockpiling, the working group that wrote the recommendations considers them appropriate and the pandemic threat great enough to justify the investment in the context of other preparedness measures, the document says. Providing antiviral prophylaxis to the families of healthcare and emergency workers is not recommended, because they have no greater risk of pandemic flu than the general population The problems of cost and limited shelf-life may be reduced through programs recently announced by the antiviral manufacturers, whereby organizations can reserve an up-to-date supply of the drugs by paying a small annual per-regimen fee, the revised guidance says. At the time of a pandemic, organizations could pay for the drugs and receive them within 48 hours. The agency added two significant pieces to the guidance in response to comments. One addresses implementation difficulties, mainly concerning barriers to the stockpiling of antivirals for health and emergency workers; the other deals with risks and uncertainties, such as antiviral resistance and treatment effectiveness. Its recommendations are just that—not standards of care or requirements HHS says the 28 comments it received on the draft guidance came from public health workers, healthcare providers, healthcare organizations, the pharmaceutical industry, business associations, public health organizations, and labor groups, among others. See also: “Antiviral resistance does represent a threat to the potential effectiveness of treatment and prophylaxis,” HHS acknowledges in its responses to the comments. The emergence of oseltamivir resistance in some influenza A/H1N1 viruses last winter illustrated this. But there is no evidence that use of oseltamivir induced this resistance, and H1N1 and other seasonal flu viruses remain susceptible to zanamivir, the agency adds. Editor’s note: This story was revised Dec 17 to include an item that was mistakenly left out of the list of five main recommendations on antiviral use in a pandemic. In addition, the guidance says that a recent declaration by HHS Secretary Mike Leavitt provides that state and local governments will be immune to liability related to the use of oseltamivir and zanamivir only to the extent the drugs are obtained by voluntary means, not confiscation. The Public Readiness and Emergency Preparedness (PREP) Act gives the HHS secretary the authority to do that, the document states. Some other comments addressed several of the same difficulties mentioned by those who commented on the general guidance: the cost of antivirals, limited shelf-life of the drugs, and the possibility of government confiscation. In its response, HHS makes generally the same points as in its response to comments on the general guidance. The PREP Act provides immunity from tort liability for both public and private groups that make, distribute, and administer antivirals in accordance with the HHS secretary’s declaration, the guidance says. In addition, the guidance document says that mathematical modeling studies suggest that “antiviral treatment and prophylaxis would remain beneficial overall unless some of the pandemic viruses introduced into the U.S. at the beginning of a pandemic are both resistant and fully transmissible.” Lowering barriers to implementationSeveral commentators said private organizations are unlikely to buy antivirals for their employees because of the cost, and several suggested that the federal government should buy the additional supplies needed to implement the guidance, according to HHS. Others said more information and materials were needed to support implementation. Treating people with pandemic flu who present for care early during their illness and would benefit from such treatment As for the possibility of government seizure of private antiviral supplies, the revised guidance says this would be very unlikely. Health officials who participated in a working group convened by the Association of State and Territorial Health Officials (ASTHO) “recognized the benefits of enhanced preparedness and coordination between public and private sectors and emphasized that this authority would be very unlikely to be used,” HHS says. The thrust of the general guidance is that, in a pandemic, antivirals should primarily be used to treat the sick, but they should also be used to prevent illness in high-risk healthcare and emergency workers and to both prevent and treat illness in the context of initial outbreaks both in the Untied States and overseas. The guidance pertains mainly to the two licensed neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Leavitt made the declaration on Oct 10 on grounds that governmental seizure of antivirals “would undermine national preparedness efforts and should be discouraged,” it adds. The Department of Health and Human Services (HHS) issued its draft guidance on the topic in June. A revision released yesterday includes no major changes but does have some new material added in response to comments, particularly on implementation problems and risks and uncertainties. No members of the interagency working group that wrote the guidance had ties to the antiviral drug manufacturers, and the latter were not included or consulted in developing the guidance The guidance also states that the antivirals may be less effective if “the usual dose and duration of therapy are not optimal for a pandemic virus.” In the responses to comments, HHS says that side effects of oseltamivir and zanamivir are uncommon. However, the guidance says that widespread use of the drugs may lead to the identification of new side effects. It notes that neurobehavioral problems have been seen in a few people treated with oseltamivir The revised guidance says that barriers to antiviral stockpiling for healthcare workers include not only the cost, but also drug shelf-life, the potential for seizure of private stockpiles by state health departments, and liability concerns. These problems were identified in the stakeholder meetings conducted in developing the guidance. Prophylaxis of healthcare and emergency services workers who are not at high exposure risk, people with compromised immune systems who are less likely to be protected by pandemic vaccination, and people living in group settings such as nursing homes and prisons if outbreaks occur in their facilities The five main recommendations are unchanged in the revised guidance. It calls for using antivirals for the following purposes: Revised guidance for employersThe revised guidance on employer stockpiling of antivirals, like the draft released in June, recommends that businesses providing frontline healthcare and emergency services plan to provide preventive antivirals for employees who will be exposed to sick people in a pandemic. It also says that critical infrastructure employers should “strongly consider” providing antiviral prophylaxis for essential workers. In its responses to the comments, HHS also states that: In a separate document, HHS says it received comments on the draft employer guidance from 31 stakeholders, ranging from academics and labor unions to critical infrastructure companies and public health groups. Several of the comments focused on whether antiviral stockpiling would be considered a “standard of care.” In its response, HHS says its recommendations are only guidance and do not establish a requirement, but rather represent a prudent approach. The revised version also reiterates that employers will have to acquire their own antiviral stockpiles for preventive use, since there are no plans for major expansion of public stockpiles. Despite the various measures designed to facilitate implementation of the guidance, some organizations will probably not have “the capacity or willingness to comply,” the document states. “In such settings, it is important to emphasize that antiviral drugs are only one component of a comprehensive program to protect workers and maintain essential services.” HHS report “Considerations for Antiviral Drug Stockpiling by Employers in Preparation for an Influenza Pandemic” Jun 3 CIDRAP News story “HHS offers pandemic guidance on masks, antivirals”last_img read more

Arsenal ease to victory, Batshuayi grabs Dortmund comeback win

first_imgElsewhere, Patrick Cutrone and Fabio Borini scored as AC Milan claimed a 3-0 lead over Ludogorets Razgrad to take back to the San Siro for the second leg.Mario Balotelli scored twice, but 10-man Nice blew a two-goal lead to lose 3-2 at home to Lokomotiv Moscow as Manuel Fernandes hit a hat-trick, while Valere Germain struck two goals as Marseille cruised past Braga 3-0.Aritz Aduriz’s double helped Athletic Bilbao win 3-1 at Spartak Moscow, while Salzburg snatched a 2-2 draw at Real Sociedad with a 94th-minute leveller.Share on: WhatsApp Paris, France | AFP | Mesut Ozil scored as Arsenal eased to a 3-0 victory at Swedish minnows Ostersunds in the first leg of their Europa League, last-32 tie on Thursday, while Michy Batshuayi snatched Borussia Dortmund a dramatic win over Atalanta.Left-back Nacho Monreal put Arsenal into an early lead with his fifth goal of the season, tapping in after home goalkeeper Aly Keita inexplicably let the ball slip from his grasp. The visitors were also gifted the second goal in the 24th minute as Ostersunds tried to play their way out of their own area, with Henrikh Mkhitaryan latching onto the loose ball and seeing a low cross diverted into his own net by defender Sotirios Papagiannopoulos.Ostersunds coach Graham Potter, a former defender for Stoke and West Brom in England, made two half-time changes in an attempt to change the flow of the game, but Arsenal all but ended the tie before the hour mark.Mkhitaryan played in Ozil, who jinked his way through and saw his shot burst through the hands of the hapless Keita and bobble into the net.Ostersunds were gifted a chance to at least add a memorable goal to their fairytale run, but after Tesfaldet Tekie was brought down by Hector Bellerin, David Ospina saved Tom Pettersson’s injury-time penalty.The comfortable win means that Arsenal manager Arsene Wenger will be able to rest his key players for the second leg at the Emirates in a week’s time.center_img – Red-hot Batshuayi rescues Dortmund –Batshuayi continued his good form with a late brace as Dortmund fought back to beat Atalanta 3-2 at Signal Iduna Park.Dortmund forged ahead on the half-hour mark as Andre Schurrle did well to control Lukasz Piszczek’s pass and turn the ball in for only his second goal of a disappointing campaign.But Atalanta, who impressed in finishing ahead of Lyon and Everton at the top of Group E, scored an away goal only six minutes into the second half.Josip Ilicic showed excellent composure to control Leonardo Spinazzola’s long pass and curl into the far corner, before the Slovenian striker tapped home just five minutes later with his fourth goal of the competition.Dortmund hit back midway through the second half, though, as Batshuayi slammed in his fourth goal in three games for the club since joining on loan from Chelsea in January.And the Belgian striker pounced in the first minute of added time to give the two-time runners-up a precious lead in the tie.last_img read more

Runner Who Groped Reporter on Live TV Charged with Sexual Battery

first_img“It’s not OK to help yourself to a woman’s body just because you feel like it,” Bozarjian told CBS News. “It’s not playful. He hurt me both physically and emotionally.”Bozarjian filed a police report, saying Callaway slapped and grabbed her. He was booked and charged Friday afternoon.Callaway publicly apologized for the incident on WSAV last Tuesday, saying, “It was an awful act and an awful mistake.” He added that he did not intend to slap and grab Bozarjian.To the man who smacked my butt on live TV this morning: You violated, objectified, and embarrassed me. No woman should EVER have to put up with this at work or anywhere!! Do better.— Alex Bozarjian (@wsavalexb) December 7, 2019 A Georgia man who groped a reporter on live TV last weekend as he ran past her during a fun run has been charged with sexual battery.Alexandrea Bozarjian was covering the Savannah Bridge Run for NBC affiliate WSAV on December 7 when the man, who was later identified as 43-year-old Thomas Callaway, appeared to slap her butt as he ran past her and the camera.In video of the incident, Bozarjian looks surprised and stares off in the direction in which the man continued running before resuming her report.— Alex Bozarjian (@wsavalexb) December 12, 2019 Georgia state law defines sexual battery as making “physical contact with the intimate parts of the body of another person without the consent of that person.”Such action is a misdemeanor that is punishable by up to one year in jail.last_img read more

Death up to 22 from Turkey earthquake; 1,100 hurt

first_imgThe magnitude-6.8 quake, centred on the town of Sivrice in Elazig province of Turkey, caused multiple buildings to collapse and has injured over 1,000 people.Rescue workers try to reach people under a collapsed building following a strong earthquake in Elazig in the eastern Turkey, Saturday, Jan. 25, 2020. The earthquake rocked eastern Turkey on Friday, causing some buildings to collapse and killing scores of people, Turkish officials said. (IHA via AP) Officials say the death toll is now up to 22.Rescue teams continue to work overtime in search for survivors.Turkey’s disaster and emergency preparedness agency says the earthquake was followed by 398 aftershocks.Turkish President Recep Tayyip Erdogan attended the funeral of a mother and son killed in the quake while visiting the hardest-hit areas Saturday afternoon.last_img read more

Three Youths Detained After Gunfire in West Palm Beach

first_imgThree juveniles have been detained in connection with a shooting incident that occurred Wednesday afternoon, according to the West Palm Beach Police Department.No injuries were reported, although at least one apartment received damage from the gunfire, says Sgt. David Lefont, police spokesman.Officers responded just after 4:30 p.m. to the 3900 block of 36th Court, after the city’s ShotSpotter gunshot detection system detected gunfire.This is a developing story.last_img

Trump signs $484 billion measure to aid employers, hospitals

first_imgPresident Donald Trump has signed a $484 billion bill that aids employers and hospitals amid the coronavirus pandemic.The bill was approved by Congress on Thursday and it is the latest effort by the federal government to help keep afloat businesses that have had to close or dramatically alter their operations as states work to slow the spread of the virus.Trump said most of the funding in the bill would flow to small business through the Paycheck Protection Program, which provides money to small businesses to keep workers on their payroll. The Paycheck Protection Program ran out of money last week.“Great for small businesses, great for the workers,” Trump said.The bill will also provide hospitals with more money and will implement a nationwide virus testing program to facilitate reopening the economy.The four coronavirus relief bills approved so far by Congress would deliver at least $2.4 trillion for business relief, testing and treatment, and direct payments to individuals and the unemployed, according to the Congressional Budget Office.last_img read more

These Bombers take longer road to Field Hockey Provincials

first_imgIt wasn’t the easiest of roads, but the L.V. Rogers Bombers are heading back to the BC High School Girl’s Field hockey Championships.Hanna Quinn scored on her own rebound to spark the Bombers to a 2-0 victory over J. Lloyd Crowe of Trail in the final of the West Kootenay Girl’s Field hockey League Tuesday at Pass Creek Park in Castlegar.Naomi Perkins also scored while Rylee Zondervan pitched the shutout as the Bombers now represent the zone at the BC High School Girl’s Field hockey Championships the first week in November in Victoria.“The LV Rogers Lady Bombers field hockey team may have taken the long road to repeat as Kootenay Zone Champions but it is very sweet indeed,” said Bomber skipper Bruce Walgren following the past few hectic days of post-season action.“After coming second in league play to arch rival J. Lloyd Crowe, the Bombers had to play Stanley Humphries of Castlegar in a semi final on Monday the winner then would have to play Crowe the very next day (Tuesday) . .  . which is a tall order for any team,” Walgren added.LVR, finishing league play in second spot behind regular season champ J. Lloyd Crowe Hawks, started on the road to greatness Monday by stopping Stanley Humphries Rockers of Castlegar 3-0 in semi final action.LVR started the game off slow allowing the Rockers to take the game to the Bombers from the start.It appeared Stanley Humphries might be rewarded for their efforts but strong defensive play led by Kyra Burkart, Emma Gregorich, Heather Potkins and Julia Burkart combined with steady goal keeping of Rylee Zondervan, who suffered an injury during warm up, kept Castlegar from converting on numerous short corners. After surviving the onslaught, the Bombers began to take over the game thanks to relentless checking of forwards Hanna Quinn, Emma Borhi, and Kaitlyn Daly, which the Bomber midfield of Naomi Perkins, Allie Zondervan and Noa Butterfield were quick to exploit. The pressure paid off as Emma Borhi scored to give LVR a 1-0 lead at the half. LVR kept up the strong play in the second half and were rewarded with goals from Allie Zondervan and Perkins to secure the three-goal victory.Tuesday, Crowe and LVR provided spectators with one of the best competitive field hockey game ever played in the West Kootenays.From the get-go Crowe took the play to the Bombers.However, the bend-but-don’t-break LVR defence never broke.The back-and-forth play by both teams made for a scoreless first half.Walgren said some small adjustments at half and a determined speech by Emma Borhi lit a fire under the Bombers.This allowed LVR to strike fast in the second half.A quick shot by Quinn minutes into the half was stopped by the Crowe keeper.However, Quinn pounced her own rebound to poke the ball across the goal line to give the Bombers a 1-0 lead.“The goal gave the Bombers a boost which they need as Crowe pressed the LVR defence again and again looking for a way to the Bomber goal,” Walgren explained.Crowe continued to press LVR, earning three consecutive corners.But the Bomber defence was equal to the challenge.After the third corner, the Bombers moved the ball systematically up the field before Perkins smashed a shot past the Crowe keeper for some late insurance and another date at the provincial tournament.last_img read more


first_imgFINISH LINES: B. Wayne Hughes, owner of recently retired three-time champion Beholder, was a Clockers’ Corner visitor Thursday and reported the soon-to-be seven-year-old mare doing well at his Spendthrift Farm in Kentucky where she will be bred to Uncle Mo this spring. “I see her every morning and she’s got herself a partner (in another mare),” Hughes said. “They’ve bonded and they can’t get more than two feet from each other. I’m happy and she’s happy. She’s done everything perfectly.” . . . Santa Anita, which will offer a $1 million guaranteed Late Pick 4 on opening day, also will offer $300,000 guaranteed Late Pick 4 pools on Thursdays, Fridays and holiday Mondays (except Opening Day) throughout the Winter/Spring Meet, as well as a guaranteed $500,000 Late Pick 4 and $100,000 Pick 6 on weekends (except Super Bowl Sunday, Feb. 5). STEVENS UNDERGOES HIP SURGERY NEXT WEDNESDAY            Hall of Fame jockey Gary Stevens will undergo surgery to have his left hip replaced next Wednesday at St. John’s Hospital in Santa Monica. Winner of more than 5,000 races in North America and a three-time Kentucky Derby winner, the 53-year-old native of Caldwell, Idaho is optimistic things will go well and he eventually can resume his riding career.“I’m looking forward to getting the old hip out of there and a new one in,” Stevens said Thursday morning at Clockers’ Corner. “I’ve never had any issues on my left side. It’s sort of been the workhorse all of my life.“I had Perthes disease (a degenerative ailment) in my right hip as a little kid (at age seven) and then the bad knee and everything, and this thing’s always done all the work, but when it went there was no warning, no nothing. About five months ago it started bugging me, and it seemed like overnight it went south and I knew something wasn’t right. Then when I got the X-rays I knew why.”Asked if he would continue to ride if all went well, Stevens said, “It’s something I’m going to evaluate. It’s too early to say. Even with the outcome (of the surgery), I have to make some decisions. Even if I don’t return to ride competitively, I want to be able to get on horses and be in comfort, but I really don’t know, because this came as such a jolt.“I was looking forward to opening day at Santa Anita and possibly riding Mor Spirit in the Malibu. When I saw the doctor, I literally was looking to get a routine injection. I’m sitting there and the doctor says, ‘I’ve got a space available next Wednesday,” and I said, ‘For what?’ and he said, ‘replacement. Your hip is gone.’ Then he showed me the X-rays, and I was by myself. My wife (Angie) wasn’t with me.“He said I could book the surgery date but I said I wanted to talk with my wife first. I did, and when I called her, she said, ‘Just do it.’ When the doctor came back, I said, ‘Let’s do it.’” RETIRED RIDING CHAMP GOMEZ FOUND DEAD IN TUCSON            The racing world Thursday mourned the passing of riding great Garrett Gomez who was found dead Wednesday in his hometown of Tucson, Arizona. According to several media reports, Gomez, who had been living primarily in Tucson the past two years, was discovered dead at a casino/hotel he had checked into on tribal land near Tucson.Gomez would have been 45 on New Year’s Day.A remarkable talent who was regarded as perhaps the strongest finisher of his era, Gomez was America’s leading rider by money won four consecutive years, from 2006 through 2009. He was voted America’s Eclipse Award champion jockey in 2007 and 2008 and was selected by a vote of jockeys nationwide as winner of Santa Anita’s George Woolf Memorial Jockey Award in 2011.The son of a jockey, Louie Gomez, Garrett last rode at Keeneland in October 2013. He won 3,769 career races and along with agent Ron Anderson, set a single-season record in 2007 by winning 76 added-money races. The following year his mounts accounted for a career high $23,344,351, just $10,000 shy of Jerry Bailey’s all-time single season record.An avid golfer, Gomez, who along with his second wife, Pam, owned a home in nearby Duarte, is survived by four children, a son, Collin, and a daughter, Shelby, from his first marriage, and by a daughter, Amanda, and son, Jared, from his second.            “It’s sad,” former contemporary Gary Stevens said. “He’s at peace now. He was as good a rider as I’ve ever ridden with, a helluva guy and a helluva  competitor. I didn’t like getting beat but when he showed up, he was on his game.“The ride he put up on Blame (defeating Zenyatta by a dramatic head in the 2010 Breeders’ Cup Classic for her lone defeat), he wasn’t healthy when he rode him. He had fallen and I know he was hurting that day, but that’s the kind of athlete he was. He rose to the occasion and overcame pain and was able to get the job done.”Added Jerry Hollendorfer assistant Dan Ward: “He was a super guy who always took care of the workers at the barn after a win. When Ron Anderson had his book, the day after Garrett won a big race he would always ask for names of the grooms to stake them.” BAFFERT HAS ARROGATE, DREFONG ON TARGETBob Baffert is at it again.Trainer of the first Triple Crown winner in 37 years, American Pharoah in 2015, and winner of three straight Breeders’ Cup Classics, the Hall of Fame member who turns 64 on Jan. 13 conditions the apparent successor to soon-to-be-retired California Chrome’s lengthy reign as master of his domain in Juddmonte Farm’s Arrogate, upset winner of Chrome in the Breeders’ Cup Classic at Santa Anita on Nov. 5.Baffert is considering the $200,000 San Pasqual Stakes on Jan. 1 for Arrogate, who worked five furlongs Tuesday at The Great Race Place in a bullet 58.40, fastest of 77 drills at the distance. The San Pasqual could lead to the $12 million Pegasus World Cup Invitational at Gulfstream Park on Jan. 28.Baffert also has Breeders’ Cup Sprint winner Drefong in good form for the Grade I Malibu Stakes for three-year-olds at seven furlongs on opening day, Dec. 26, not to mention his primary Triple Crown prospect this year, Mastery, winner of last Saturday’s Grade I Los Alamitos Futurity, who could make his three-year-old debut in the Robert B. Lewis Stakes on Feb. 4 or the San Felipe Stakes on March 11. BAFFERT IN PRIME TIME AT SANTA ANITA AGAINRACING MOURNS PASSING OF GARRETT GOMEZSTEVENS TO HAVE HIP REPLACEMENT SURGERY BEHOLDER HAPPY, AWAITS SERVICE TO UNCLE MO$1 MILLION LATE PICK 4 GUARANTEE OPENING DAYlast_img read more