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FDA seeks comments on controversial anthrax vaccine

first_imgJan 13, 2005 (CIDRAP News) – As a result of a federal court ruling that stopped the US military’s anthrax vaccination program last October, the Food and Drug Administration (FDA) is asking for public comments on its finding that the anthrax vaccine is safe and effective. A week after the ruling, the FDA responded with a statement, based on the findings of an expert panel in 1985 and subsequent research, that the vaccine is safe and effective for all forms of anthrax. In response, Sullivan lifted his injunction against the DoD vaccination program. But in October 2004, Sullivan said that the FDA had failed to follow its own rules in not soliciting public comments before confirming (in December 2003) that the vaccine is approved for all forms of anthrax. Citing a 1998 law that bars DoD from forcing military members to take drugs not approved for their intended use, Sullivan said military personnel could not be forced to receive anthrax shots without a special presidential order. DoD then suspended the vaccination program. In the notice, the FDA concedes that the 1950s clinical trial data on which its licensing decisions were largely based included too few cases of inhalational anthrax to show clearly that the vaccine prevents that disease. But the notice says the trial data show that the vaccine’s efficacy against all types of anthrax combined was 92.5%. In 1985, an FDA expert panel recommended confirming the approval of the anthrax vaccine, along with various other bacterial vaccines and toxoids. In December 1985, FDA proposed to confirm the approvals and gave the public 90 days to comment on them. The agency received no specific comments on AVA at the time. AVA, also called BioThrax, is made by BioPort Corp. of Lansing, Mich. HHS announced last November that it planned to buy 5 million doses of the vaccine for potential civilian use. HHS also has contracted with VaxGen, Inc., to produce 75 million doses of a new, not-yet-licensed anthrax vaccine that officials hope will require fewer doses and have fewer side effects than the existing vaccine. The existing vaccine requires six doses over 18 months, followed by annual boosters. Last month, DoD officials asked the Department of Health and Human Services (HHS) for emergency authority to resume the vaccination program because of what they said was an increased risk of anthrax attacks on US forces. HHS officials were still reviewing that request as of yesterday, Marc Wolfson of the HHS Office of Public Health Emergency Preparedness told CIDRAP News. A federal judge in Washington, DC, ruled in December 2003 and again in October 2004 that the FDA acted improperly in authorizing the use of the anthrax vaccine to prevent inhalational anthrax, as distinguished from cutaneous anthrax. The military vaccination program has been on hold since the October ruling. The FDA rules that Sullivan said the agency ignored went back to 1972, when the FDA took over the licensing of drugs and vaccines from the National Institutes of Health (NIH). The FDA then set up a procedure for reviewing products that had been licensed by the NIH. The procedure included reviews by independent expert panels and inviting public comments before confirming the product approvals. The FDA notice is the latest chapter in a dispute between the government and military personnel who are fighting the anthrax vaccination program because of concern about side effects. Since 1998, about 1.25 million Department of Defense (DoD) personnel, mostly those serving in the Middle East and Korea, have received the vaccine. But some have resisted the shots and been disciplined or forced out of the military as a result. The two court rulings came in a lawsuit filed by six military members and civilian contractor personnel. In the first ruling, in December 2003, US District Judge Emmet G. Sullivan concluded that AVA had never been specifically approved or labeled for use against inhalational anthrax, which is the form the military is most concerned about. In the controlled trial, called the Brachman study, 1,249 workers at four textile mills that processed goat hair received either AVA, a placebo, or no treatment. Five cases of inhalation anthrax occurred in the trial, all in unvaccinated workers. There also were 21 cases of cutaneous anthrax, all but three of them in unvaccinated workers. The agency concludes that the vaccine label doesn’t need to state what route of anthrax exposure the vaccine is intended for. “We propose the indication section of the labeling for AVA [Anthrax Vaccine Adsorbed] not specify the route of exposure, and the vaccine be indicated for active immunization against Bacillus anthracis, independent of the route of exposure,” the notice states. In the Federal Register notice, the FDA describes the 1950s clinical trial of AVA and later epidemiologic data on the vaccine’s efficacy and safety. In an effort to overcome the court’s objections, the FDA on Dec 29 quietly published a Federal Register notice explaining its proposal to reaffirm the vaccine’s approval and also inviting the public to comment on the matter. The deadline for comments is Mar 29. The notice also cites some epidemiologic data in support of the FDA proposal to reconfirm the AVA approval. The Centers for Disease Control and Prevention collected data on anthrax cases in industrial settings from 1962 to 1974 and also monitored adverse reactions to the vaccine in about 7,000 at-risk workers from 1967 to 1971. From the latter study, the expert panel concluded that the vaccine was “fairly well tolerated” and that severe local reactions and systemic reactions were “relatively rare.” Also in support of the vaccine, the FDA notice cites a small clinical study conducted by DoD after 1985 and data collected by the Vaccine Adverse Event Reporting System. In addition, the report cites the 2002 analysis by the Institute of Medicine, which found that the vaccine was “acceptably safe” and effective against inhalational and other forms of anthrax. The 1985 expert panel said that ethical concerns and the low incidence of anthrax make it impossible to conduct further controlled clinical trials of the vaccine, according to the notice. The expert panel concluded that the vaccine provided 93% protection overall but that cases of inhalational anthrax were too few to assess the vaccine’s effect against that form of anthrax, the Federal Register notice says. According to Sullivan’s October 2004 ruling, the FDA never followed up with specific confirmation of the AVA licensing until after his December 2003 ruling. When the FDA then said the vaccine was effective for all forms of anthrax, it relied partly on post-1986 research findings, on which the public never had a chance to comment, according to the judge. “FDA agrees that the five cases of inhalation anthrax reported in the course of the Brachman study are too few to support an independent statistical analysis,” the notice states. But it adds that the study included all types of anthrax, the overall efficacy of the vaccine was 92.5%, and no inhalational cases occurred in vaccinated workers. Therefore, the FDA proposes to label the vaccine for anthrax immunization without specifying the route of exposure.last_img read more

‘IT’S NOT THAT SIMPLE’ IPPO claim on pro-NPA local execs met with skepticism

first_imgWhile the NTF-ELCAC aims awhole-of-nation approach in attaining inclusive and sustainable peace, thePTF-ELCAC’s tack would be whole-of-province.  According to the governor, the situation may be a little morecomplex. These road networks are envisioned tousher economic development even in far-flung areas. Economic difficulty is oneof the factors driving people to rebel, Defensor explained. “It’s not that simple. Angaton local government officials work on the ground. They are in constantcontact with their constituents. So I have to be clarified kon ano ang buot silingon sang ‘support’ nga amo sina. Usisaon anay,”said Defensor. “This is good because the thrust ofGovernor Defensor is social justice. The framework is already there. All wehave to do is make the implementation plan,” said Department of Interior andLocal Government (DILG) Iloilo director Teodora Sumagaysay. According to the Police RegionalOffice 6 (PRO-6), 32 elected local officials in Western Visayas enjoyed thesupport of the NPA in the May midterm elections and could now be paying therebels back with support. “We need physical evidence to pin themdown,” said Malong. “I need time to investigate that and to confer with the policeprovincial director. What does ‘supportive’ mean,” said Defensor. What were the prevailing circumstances that led to suchconclusion, he asked. Malong, however, acknowledged it wouldbe difficult to prove that these local officials are now paying the insurgentsback with monetary or logistical support unless witnesses surface. Defensor expressed alarm over theseries of clashes between government troops and rebels in the municipalities ofMiag-ao and Igbaras. In Capiz, according to Malong, therewere four mayors, two vice mayors and three town councilors while inNegros Occidental, there were two elected mayors, two vice mayors, twomunicipal councilors, and a provincial board member. ILOILO – Gov. Arthur Defensor Jr. is not about to swallow hook,line and sinker the Iloilo Police Provincial Office’s (IPPO) claim that five mayors,two vice mayors and nine municipal councilors are supportive of the NewPeople’s Army (NPA). PRO-6 spokesperson Police LieutenantJoem Malong said of these 32 officials, 11 were elected mayor and six wereelected vice mayor. The provincial government will beforming the Provincial Task Force to End Local Communist Armed Conflict(PTF-ELCAC) – a local counterpart of the National Task Force to End LocalCommunist Armed Conflict (NTF-ELCAC) that President Rodrigo Duterte createdDecember last year. While Defensor intends to get more facts from Vilela, the governorreiterated the goal of the Duterte administration which is to solve theinsurgency problem and achieve inclusive and sustainable peace through goodgovernance. IPPO director Police Colonel Roland Vilela had said these mayors,vice mayors and municipal councilors were paying revolutionary tax to the NPA andduring the midterm elections they paid the rebels “permit to campaign” fees. Defensor said the provincialgovernment has programs that could help address the insurgency problem; one ofthese is building road networks even in remote areas. “’Di ba it’s a formof support,” said Vilela. Local officials proven to besupportive of rebels face criminal and administrative charges. Based on DILG Memorandum Circular2019-125, a joint resolution of the Provincial Peace and Order Council (PPOC)and the Provincial Development Council (PDC) is needed for the creation of thetask force. It will be chaired by the governor./PNlast_img read more

Waite goes for 500th career win this weekend

first_imgBEN CLASSON/Herald photoThis weekend, the Wisconsin volleyball team will have its home opener at the UW Field House for the Inntowner Invitational.The Badgers (5-1), who dropped to No. 14 in the AVCA Coaches Poll after a loss at the UNLV Invitational, will face Central Michigan on Friday night. On Saturday, they will play both IUPUI and No. 23 Brigham Young.“You get to be in an atmosphere you are used to playing,” junior outside hitter Katherine Dykstra said of playing at home. “It’s your fans, and everybody is rooting for you. So it will definitely be a relief to be back home and play in our home stadium.”Central Michigan, who just won the Country Inn and Suites Championship in Chattanooga, Tenn., will be looking to upset the Badgers going into the first game of the tournament. The Chippewas are lead by senior middle blocker Whitney Evers, who is averaging 3.55 kills per game and a .465 hitting percentage.“They will bring the heat because we have a big target on our backs,” senior outside hitter Morgan Salow said.  “I think they will challenge us to just play our game and stay on our level instead of working down to theirs.”On Saturday, the Badgers will have to play both IUPUI and Brigham Young.  Last year, the Badgers lost to the Cougars on the road in five games. This year, Wisconsin will have to match up against BYU’s stingy defense at home, which averages over 1.00 block per set. BYU is also the first ranked team the Badgers will play this year.“It’s great playing them at home, and I don’t think there is any extra pressure,” head coach Pete Waite said. “I think the kids get up for a team like that because they know they really have to play their best to get the win.”On the Wisconsin side of the net, the Badgers will be looking to get the ball to Dykstra, who is having one of the best seasons of her career. Against UNLV last weekend, she had a career-high 21 kills. She is also leading the team in that category, with an average of 3.43 kills per game and a .348 hitting percentage. Dykstra is also leading the team with .90 blocks per game.Waite attributes her success to the fact she is not only getting really good sets but is also making do with sets that are not on target. Dykstra agrees she is hitting the ball a lot better than last year and connecting well with her setters.“This is what we were waiting for, and she has been coming on and getting stronger each season,” Waite said.Also, look for the Badgers to continue mixing up their lineup this weekend. For the past two weekends, they have gone from a one-setter system on offense to using two. This allows Wisconsin to give teams different looks they may not have seen on their scouting reports or on tape.This weekend the Badgers also have the chance to help Waite reach his 500th win of his career. Since the Madison-area native began coaching at Wisconsin nine years ago, the team is 228-67 and has made nine straight NCAA Tournament appearances. The furthest Waite’s team has ever been in the tournament is the finals, where they lost to Nebraska.“It would be awesome if we can get Pete [Waite] his 500th win,” Dykstra said. “He has been a great coach, and he has been here for so long, I would love to be part of his 500th win. Hopefully we will be able to do it in front of a great home crowd.”Whether or not Waite does get his 500th victory this weekend, he will have familiar company in the audience. Becky Olson, Central Michigan’s head coach Erik Olson’s wife, played for Waite during his tenure at Northern Illinois University. Also, IUPUI head coach Steve Payne was an assistant under Waite at NIU.“It means a lot,” Salow said of Waite’s accomplishments. “It shows how good of a coach he really is and how hard he has worked in his career. It shows he has brought a lot of good people in his program and worked on it really well.”last_img read more