Court ruling again stops anthrax shots for US soldiers

first_img See also: US District Judge Emmet G. Sullivan of Washington, DC, ruled yesterday that the Food and Drug Administration (FDA) failed to follow proper procedures in approving use of the anthrax vaccine to prevent inhalational anthrax. According to a Washington Post report today, Mark Zaid, a lawyer for the six plaintiffs, said he would take steps to reverse all penalties inflicted on soldiers who refused to take the vaccine. He also promised to seek compensation for those who claim they were harmed by the vaccine. The judge said the FDA took no further action until December 2003, shortly after his initial ruling in the lawsuit. In confirming the vaccine’s license at that time, and saying it was effective for all forms of anthrax disease, the FDA relied partly on post-1986 research findings, on which the public never had a chance to comment, according to Sullivan. “By refusing to give the American public an opportunity to submit meaningful comments on the anthrax vaccine’s classification, the agency violated the Administrative Procedure Act,” Sullivan wrote in the conclusion of a 41-page opinion. In 1985, the expert panel recommended confirming the approval of the anthrax vaccine and certain other products, saying the vaccine was effective against cutaneous anthrax in at-risk workers. The FDA then proposed to issue the approval and called for public comments, Sullivan wrote. Only four comments were received by the 1986 deadline, none of them specific to the anthrax vaccine. In the latest ruling, Sullivan said the FDA failed to follow its own rules in approving use of the vaccine for inhalational anthrax. He explained that the agency took over licensing of drugs and vaccines from the National Institutes of Health (NIH) in 1972. The FDA subsequently set up formal procedures for reviewing products that had been licensed by the NIH. The procedures included reviews by an expert panel and soliciting public comments before confirming the product approvals. Sullivan’s ruling came in a suit filed by six military members and civilian contractor employees. In an initial ruling in December 2003, the judge ordered DoD to stop requiring the shots on the ground that the FDA had never specifically approved the vaccine for inhalational anthrax, as distinguished from cutaneous anthrax. The FDA quickly responded with a statement, based on the findings of an expert panel in 1985 and on subsequent research, that the vaccine is safe and effective for all forms of anthrax. Sullivan then lifted his injunction in January 2004, little more then 2 weeks after he had issued it.center_img More than 1 million military personnel, mostly those serving in the Middle East, have had to receive anthrax shots since 1998. Because of worries about side effects, some troops have refused the shots and been punished or forced out of the military. Oct 28, 2004 (CIDRAP News) – The Department of Defense (DoD) has suspended its anthrax vaccination program in response to a federal court ruling that military personnel should not have to accept the shots against their will unless the president orders them to do so. “This court will not permit the government to circumvent this requirement,” the judge wrote. “The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all—public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this Court shall compel FDA to follow.” As in his previous ruling, Sullivan cited a 1998 law barring DoD from forcing its personnel to take investigational new drugs or drugs not approved for their intended use. Under the law, only the president can waive the requirement for informed consent. In response, DoD issued a statement yesterday saying it would “pause giving anthrax vaccinations until the legal situation is clarified.” The statement added, “DoD remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe.” Asserting that the vaccine amounts to “either a drug unapproved for its intended use or an investigational new drug,” Sullivan said the vaccination program is illegal unless the shots are voluntary or the president waives the requirement for informed consent. DoD news release read more

Bale staying at Madrid

first_imgGareth Bale won’t be going to Manchester United for now – that’s according to Reds manager Jose Mourinho and the player himself.The Welsh forward played in Madrid’s 2-1 win against United in last night’s UEFA Super Cup Final and Mourinho says it’s ‘game over’ because ‘everybody knows he is going to stay’.Bale says he doesn’t want to move and there’s not much more he can say. Photo © – pixabaylast_img

Don feels the pain of Titans on trial

first_imgA Grafton junior who had gone off and completed a teaching degree at the University of Newcastle, Don broke all kinds of try-scoring records playing for the Ghosts in Group 2 before being picked up to play Intrust Super Cup with Burleigh in 2012.Those try-scoring exploits carried through to the top grade with the Bears and he was offered a ‘train and trial’ contract with the Gold Coast Titans.Right now across all 16 NRL clubs there are hopefuls busting their guts in the hardest training sessions of their lives hoping, like Don did, to show the coaching staff enough to be invited to become a permanent member of the NRL squad.At the Titans this year former Shark Pat Politoni, former Titans 20s forward Hayden Schwass, 25-year-old Tweed Heads lock Sam Saville and highly-regarded former Rooster Tyler Cornish are all mixing it with the likes of Jarryd Hayne, Konrad Hurrell and Ryan James endeavouring to prove their worth.In recent years Agnatius Paasi and Cameron Cullen have turned short-term contracts into NRL starts and Don knows all too well what this year’s crop are going through.”For me personally I was pretty nervous and I’m a pretty shy bloke when I first meet someone so I was just scared trying to talk to all the high profile players like ‘Birdy’ (Greg Bird), Luke Bailey, Jamal Idris and Dave Taylor,” Don said.”I was mainly petrified even trying to strike up a conversation with someone but you’ve just got to put in on the field each week and do your best and hopefully the coaches like you.”I remember when I was doing it as well you’re trying to impress and you’re getting here early and trying to do everything right.”They put in every session just like the senior guys so collectively it’s a group of men that’s trying to achieve as much as they can in the training time that we’ve got.”With places in both the top and second tier of his playing roster still to fill, Titans coach Neil Henry knows the value of inviting players in to fight for an opportunity in the big time.Politoni and Schwass were both key figures in Burleigh’s drought-breaking Intrust Super Cup title this year and with very little back-up for hooker Nathan Peats, Politoni especially shapes as a future Titan.”With the train and trial guys there’s certainly an opportunity for some of these players to step up and probably earn a full-time contract,” Henry said.”We’ll reserve our judgement there until we see how they go before Christmas and the trial period.”Pat Politoni had a good year at hooker and it’s a role that we need some depth in within the club.”Obviously ‘Peatsy’ wants to play 80 minutes so he’s been training quite well. Young Max King out of our 20s program has been working hard and Hayden Schwass who had a full year at Burleigh in the back row straight out of 20s has been working really well as a young player coming through.”He’s got a good motor and he plays big minutes. He played mostly 80 minutes on the edge although he’s got that versatility playing edge back row.”In 66 games across four seasons Don has now scored 40 tries in the NRL but is still pushing to become a permanent member of the 17 each week.For the first time in his career the 29-year-old played a Round 1 fixture in 2016 and featured in 22 of the Titans’ 25 games but still feels he has to prove himself throughout pre-season to be on the wing for the first game of the season in 2017.”Throughout my career I’ve never really had a spot cemented for the whole season so I’m not going to get ahead of myself,” Don said in the wake of David Mead, Josh Hoffman and Nene Macdonald all leaving the club in the off-season.”I know I’ve still got to compete hard to try and get a spot and hopefully I can do that through my pre-season form and throughout the trial games and start of the season.”There are a lot of guys there that can play those positions so it’s still going to be a tough pre-season and a lot of competition for spots.”last_img read more