In an appeal filed May 16, DoD is arguing that the lower court judge overrode the Food and Drug Administration’s (FDA’s) scientific judgment on the vaccine and that the injunction is endangering “countless” service personnel for the sake of the six people who sued to stop the vaccination program. “The district court compounded that error by substituting its own judgment of AVA’s efficacy for the contrary scientific conclusions of the Food and Drug Administration,” the brief states. Jim Turner, a Pentagon spokesman, said the plaintiffs in the case are due to file a response to the DoD appeal by Jun 30. Last January, the FDA issued an emergency authorization for DoD to resume giving anthrax shots, but only on a voluntary basis. After getting Sullivan’s approval of the emergency authorization, DoD announced earlier this month that the voluntary program would go forward. But officials said they would continue to seek authority to restore the mandatory program. “The sweeping injunction . . . sets aside the military’s judgment as to the optimal means for protecting against the threat of anthrax without any gain in safety,” the brief states. “The interests of thousands of members of the armed forces are not aligned with those of the six plaintiffs. The court’s ruling jeopardizes the safety of the countless persons who have never been made part of this action.” May 25, 2005 (CIDRAP News) The Department of Defense (DoD) is seeking a federal appeals court’s permission to revive its mandatory anthrax vaccination program, which was stopped by a lower court’s ruling in October 2004. A May 23 report by GovExec.com said John Michels, attorney for the plaintiffs, declined to comment on the DoD appeal before the response is filed. More than 1.3 million people have received the anthrax vaccine, called Anthrax Vaccine Adsorbed (AVA), in the DoD program since 1998. But the vaccine has been dogged by concerns about alleged side effects. Hundreds of service members have refused the shots, and some have been punished or forced out of the military. It says the FDA has repeatedly confirmed that the vaccine is effective for all forms of anthrax exposure. DoD asserts that Sullivan’s ruling relied on the finding of a 1985 FDA advisory committee that the vaccine’s “efficacy against inhalation anthrax is not well documented.” But the FDA has explained that that conclusion was based on a “misunderstanding” of the data, the brief says. DoD appealed Sullivan’s ruling to the US Court of Appeals for the District of Columbia Circuit. In its brief, the department argues that Sullivan’s ruling “intrudes” into the military’s efforts to protect troops from possible anthrax attacks. DoD also argues that it is “wholly unnecessary” to stop the entire vaccination program for the sake of the six service members and civilian contractor employees who sued the department over objections to the shots. Moreover, even if the FDA’s actions affirming the vaccine were “ineffective,” the vaccine’s original license granted in 1970 by the National Institutes of Health (NIH) would still be in effect, DoD contends. That license was not limited to particular routes of anthrax exposure. “Formal FDA confirmation of the license was not required to ratify the terms of a license already in existence,” the brief states. The NIH was responsible for licensing vaccines and drugs until 1972. US District Judge Emmet G. Sullivan in Washington, DC, ruled late in 2003 that the FDA had never specifically approved use of the vaccine for preventing inhalational anthrax. The FDA then affirmed that the vaccine could be used for that purpose, but in October 2004, Sullivan ruled that the agency had ignored its own rules in making that affirmation without inviting public comments.
“He is very happy because it is his first (league) goal and we are very happy too because it helped the team get the three points,” Pochettino said. “It is important for him. We need to understand Erik is still young, he has a big talent but it was difficult his first season in England. “This season he is fit – in the beginning it wasn’t easy for him to play but he just needed time. “Today was great for him because he needs to build his confidence, to be more strong and when we saw his performance today he is happy because it is another step in the right direction.” A combination of injuries and poor form saw Lamela start just nine league games last season but the Argentine is showing signs of rejuvenation this term under Pochettino. Lamela posed a constant threat against Burnley with his weaving runs forward and he was also defensively diligent, fighting to win the ball back for his team in midfield. Pochettino insists there has been no magic formula behind the youngster’s improvement other than support and time. “It is the club, it is not only me who gives him the tools to improve his performance,” Pochettino said. Lamela’s long-range strike in the 35th minute proved the difference at White Hart Lane as Spurs beat the Clarets 2-1 and climbed to sixth in the Barclays Premier League table. It was a first league goal for the 22-year-old, who has struggled to adjust to the pace of English football since his £26million move to north London in August 2013. “It is our results too and the club who give him the chance to work in the best condition and try always to help him.” Pochettino added: “Last season was very difficult for him – his injury, he didn’t play so much and getting used to a different culture and language. “You need time to adapt to a new club and culture. He is very, very strong and he needs to keep going. We are very happy.” Lamela’s strike earned Tottenham their third consecutive victory after Ashley Barnes had earlier cancelled out Harry Kane’s opener. The only headache for Pochettino was an injury to Ryan Mason, who hobbled off with a twisted ankle in the second half although t he Spurs boss said afterwards the injury “didn’t look too bad”. Defeat for Burnley means Sean Dyche’s side slip back into the bottom three ahead of a tough festive period that includes games against Liverpool and Manchester City. The visitors were second best at White Hart Lane but the Clarets could have snatched a point had they been more clinical in front of goal. “I believe in my players wholeheartedly and there were great signs for what we’re trying to achieve today,” Dyche said. “We’ve come to White Hart Lane, everyone knows the money they’ve spent on the players and the quality they have. “Everyone knows they’re a side who are beginning to find some results under the new manager. “It’s not an easy task but I thought the way we went about it was first class. “We worked the keeper on a number of occasions and late in the game we were still trying to find a way to win the game.” Tottenham boss Mauricio Pochettino believes Erik Lamela’s match-winning goal against Burnley will do wonders for the winger’s confidence this season. Press Association
When was the last time Kershaw felt happy coming out of a game?“The start before this one,” he said. “Then before that, September, I guess.”Kershaw pitched pretty well, too. He allowed two runs over seven innings, both on Arenado’s home run. The left-hander walked one batter and struck out seven.The Dodgers collected 17 hits as a team. Every member of the starting lineup collected at least one and Kershaw had three — a new career high. Andre Ethier, Howie Kendrick, Adrian Gonzalez and Joc Pederson all hit home runs.Gonzalez went 4-for-4 with two doubles and Ethier, Kendrick and Jimmy Rollins had two hits apiece. Newsroom GuidelinesNews TipsContact UsReport an Error DENVER >> Clayton Kershaw and the Dodgers were due for a game like this.Their 11-4 win over the Colorado Rockies looked easy. The consensus best pitcher in baseball hadn’t had an easy game for a while, but the two runs Kershaw allowed Monday, both on a home run by Nolan Arenado, could not have meant less.The Dodgers scored six runs in the sixth inning and three more in the ninth, ensuring that Kershaw (4-3) would have a winning record for the first time all year.“I felt the last two (starts) especially I felt happy coming out of the game,” he said. “That’s a new feeling for me. I try to build on that, sure.” Gonzalez also made several nifty picks on throws in the dirt to first base. It was a byproduct of the shadows that covered the left side of the infield, but not the right, in the early innings of a game that began at 6 p.m. local time.Other than the shadows, Gonzalez said, a first baseman usually looks forward to coming to Denver. The Dodgers scored in only three of the 27 innings they played at Busch Stadium over the weekend. Denver is different.“It doesn’t have anything to do with leaving St. Louis, it has to do with coming to Coors,” Gonzalez said. “Chances are, if you put up good at-bats you’re going to have good numbers or positive stats. “I hit two balls in St. Louis that would have been homers here, or doubles,” he continued. “They ended up being outs. You turn two balls that could’ve been a homer and a double that could’ve been 0-for-2 — now the series looks bad. But if those two balls are a double and a homer, now the series is not as bad. That little bit can be the biggest difference in the world.”Once the Dodgers were done dumping syrup on the maple-bacon goodness that is hitting at a mile-high stadium, one piece of mystery meat remained on the platter: Who would start the first game of a Tuesday doubleheader, a game that was scheduled to begin roughly 16 hours after the final pitch Monday?David Huff was brought up from Triple-A prior to the game. The veteran left-hander had started one game already this season. But Huff pitched the eighth inning Monday, ruling him out.Would it be Joe Wieland, who was scheduled to start for Triple-A Oklahoma City on Tuesday? Like Huff, Wieland had already been entrusted with a spot start for the Dodgers.Or would it be Zach Lee, the 2011 first-round draft pick who’s been knocking at the door all season with a 2.38 earned-run average?“We won’t start somebody that’s never started a major league game before tomorrow,” Dodgers manager Don Mattingly said before the game.So much for Lee.Only after the game did Mattingly reveal that the Dodgers would recall left-handed pitcher Ian Thomas from Triple-A Oklahoma City. Thomas had been used as a reliever by the Atlanta Braves, who traded him to the Dodgers as part of the six-player trade that sent Juan Uribe to Atlanta last Wednesday.Thomas would not start the game, Mattingly said. Rather, the Dodgers will have eight available relievers for a “bullpen game,” and former Rockies pitcher Juan Nicasio will start. The veteran right-hander has a 1.29 earned-run average in 16 appearances out of the bullpen this season for the Dodgers.The doubleheader was needed to make up a game that was rained out at Coors Field on May 9.