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.
Buyers will receive a vehicle permit allowing them to access 20km of surf beach.AN EXCLUSIVE patch of Gold Coast paradise is up for grabs with the release of waterfront lots on South Stradbroke Island.QM Properties is developing South Stradbroke Island Waters which sits on the former site of Couran Point Resort.The initial release includes seven canal front lots from $410,000, three dry lots from $250,000 and two waterfront homes from $870,000. QM Properties is redeveloping the former Couran Point Resort site.More from news02:37Purchasers snap up every residence in the $40 million Siarn Palm Beach North11 hours ago02:37International architect Desmond Brooks selling luxury beach villa1 day agoQM Properties general sales manager Damien Ross said South Stradbroke Island Waters was a unique site that would never be overdeveloped.“Ninety per cent of the island is classified as state forest which means only a handful of lucky buyers will be able to call this unique development home,” Mr Ross said.“This is a truly boutique estate as it is the only freehold land on the island.Mr Ross said residents would not forgo any key amenities in order to live in this serene setting.“There is direct boating access to the Gold Coast Broadwater and Coomera Waters, and Sanctuary Cove Marina is only a few kilometres away,” he said.Every buyer of the freehold lots will receive a vehicle permit allowing them to access 20km of surf beach – ideal for those looking to take advantage of the Jumpinpin bar to the north and the Southport Seaway to the south.“The development really gives residents the opportunity to experience the best of both worlds with access to the natural beauty of South Stradbroke and the burgeoning communities of the Gold Coast,” Mr Ross said. Ninety per cent of the island is classified state forest.In addition to the rainforest 4WD track that connects the community to the surf beach side of the island, residents will also have access to a proposed common pool area with two pools, gazebo and amenity block.“The continued excellence of the estate is of great concern to us which is why we have put in place a quality building covenant, ensuring all residents’ property values are maximised in the future,” Mr Ross said.
By Scott ThistlePortland Press HeraldAUGUSTA — Governor Janet Mills shut the door on legalized sports betting on Friday when she vetoed a bill that would have seen Maine join 12 other states that have approved gambling on sporting events, both in person and online.The bill, one of three Mills vetoed, was among 40 she had held since the end of the last lawmaking session in June, saying they had technical issues or needed additional work. The Legislature recalled 13 of the bills last Wednesday — the sports gambling bill was not among them — to allow lawmakers to make changes that would satisfy her concerns before sending them back to her for consideration.This is placeholder textThis is placeholder textThe Governor allowed the 24 other bills to become law without her signature. Under the Maine Constitution, she was required to make a decision on the bills before midnight Saturday.Sen. Louie Luchini (D-Hancock County) sponsored the sports betting bill and was disappointed by Mills’ veto. He was in San Diego on Friday at a conference for states with gambling and said Mills called to inform him of her decision shortly before she released her two-page veto message to the public.“I appreciate that she took a real thoughtful approach and researched the topic thoroughly, and I’m willing to keep working on it to make it a more acceptable measure for anyone who has issues with it,” Luchini said. He noted, however, that as many as 20 states, Puerto Rico and the District of Columbia are poised to legalize sports betting and collect tax revenue from it in 2020.Estimates on how much sports betting would be worth in Maine varied widely, but a fiscal note attached to the bill suggests that if it were fully implemented, originally scheduled to occur in 2023, the state would collect as much as $5 million a year in fees and taxes. However, sports betting revenue forecasts fell dramatically short in several states that legalized it in 2018 and 2019.Supporters of the bill say millions of dollars in illegal sports betting, much of it online and with offshore entities, already is taking place in Maine without the state receiving tax revenue.Mills’ veto message downplayed the revenue considerations and focused on the harm the legislation could have on youth and low-income Mainers.“Before Maine joins the frenzy of states hungry to attract this market, I believe we need to examine the issue more clearly; better understand the evolving experiences of other states; and thoughtfully determine the best approach for Maine,” Mills wrote. “That approach needs to balance the desire to suppress gambling activities now being conducted illegally and the need to protect youthful gamblers and those least able to absorb losses under a closely regulated scheme.”The bill would have prohibited betting on youth sports, including high school athletics, but left the door open to some amateur and semi-pro sporting events.The bill, which would have given just about every entity with an interest in gambling a slice of the revenue, faced no formal opposition in the Legislature beyond some lawmakers voicing concern over problem gamblers. The bill would allow casino operators, off-track betting parlors, harness racing tracks and Native American tribes in Maine to host sports betting operations.The veto will be the subject of an override vote with a two-thirds majority in both the House and the Senate required to overturn Mills’ decision. The only roll-call vote on the bill taken in the Legislature so far was in the Senate last June, when the measure was approved 19-15 with a mix of Republicans and Democrats both supporting and opposing the measures. The bill gained unanimous approval in subsequent votes.House Minority Leader, Kathleen Dillingham (R-Oxford) supported the measure — her district includes the Oxford Casino — and was disappointed by the Governor’s action.“Though there may remain questions concerning potential revenues from this industry, it is clear that many Mainers already participate in sports wagering,” Dillingham said in an email Friday night. “I am concerned with our lack of oversight and the absence of consumer protections for those choosing to participate in this type of wagering.”In May 2018, the U.S. Supreme Court struck down a federal prohibition on sports betting. Since then, a dozen states — New Hampshire was the most recent state to allow the practice — have joined Nevada in allowing gambling on sporting events.