According to the documents obtained by Us, Britney, 38, previously requested that Bessemer Trust Company be the sole conservator of her estate moving forward. Her father consented to the Bessemer Trust as co-conservator, retaining him as the second party in charge in a letter filed last month.Britney Spears and Jamie Spears. Matt Baron/Shutterstock; Nick Ut/AP/ShutterstockAfter Tristar Sports and Entertainment Group resigned in October as Britney’s business manager without prior notice to the singer, her father hired a replacement, Michael Kane of Miller Kaplan, on Sunday, November 1. Britney claims he did this without consulting his daughter or advising her of the terms of Kane’s engagement or fees.“The October 28 letter is a blatant attempt by JAMES to retain full functional control of her assets, books and records in the face of BRITNEY’S objections, TRISTAR’s resignation and the appointment of BESSEMER TRUST,” the November document reads. “His simple litigation strategy is to introduce a new gatekeeper who admittedly has a major working relationship with his legal team.”- Advertisement – Britney’s lawyer pointed out that “It is now obvious that any effort to create a viable working relationship between and among BRITNEY, BESSEMER TRUST and JAMES would be doomed to failure even without the added stress of litigating BRITNEY’S objections to the Account.”Because of James’ dealings with the Bessemer Trust and Britney’s business manager, the attorney revealed that his client will be “filing a petition to remove James as conservator of the estate.” The filing also requests that Jamie be “suspended immediately upon the appointment of Bessemer Trust” as sole conservator.The request will be discussed as part of the family’s Tuesday, November 10 hearing.- Advertisement – – Advertisement – Jamie and an attorney, Andrew Wallet, were initially appointed as Britney’s conservators in February 2008 after her public breakdown and divorce from Kevin Federline. The singer shares sons Preston, 15, and Jayden, 14, with her ex.Wallet stepped down in March 2019, leaving Jamie as the sole conservator of his daughter’s estate. Six months later, Jamie temporarily stepped down from his role, due to “personal health reasons” and after an alleged altercation between him and his grandson Preston.The Crossroads star’s care manager, Jodi Montgomery, was then named her conservator in September 2019.Britney previously filed a request to have her father removed as her conservator in August stating that she “is strongly opposed to having [Jamie] return as the conservator of her person.”A source exclusively told Us at the time that “Britney does want the conservatorship of her as a person to end, but she was concerned that Jamie could attempt to have the temporary conservator removed.”The insider added: “There has been significant improvement in Britney’s overall medical treatment plan, which has been attributed to no longer having her father in charge of her personal life.”Last month, a source told Us that Jamie is “very concerned” with how much freedom Britney has had in recent months over her medical treatment with Montgomery in charge.Listen to Us Weekly’s Hot Hollywood as each week the editors of Us break down the hottest entertainment news stories! Going head-to-head. Britney Spears asked a judge to remove her father, Jamie Spears, as a co-conservator of her estate ahead of a hearing later this month, Us Weekly can confirm.The “Toxic” singer’s attorney, Sam Ingham, filed new documents on Tuesday, November 3, outlining her request to ditch her father, 68, who has been her conservator for 12 years.- Advertisement –
Image:Northern Ireland welcomed 600 fans to their recent Nations League game against Austria at Windsor Park Northern Ireland’s Paddy McNair has urged his team-mates to repeat the performance that saw them beat Greece to qualify for Euro 2016, in Thursday’s Euro 2020 playoff against Slovakia Image:Peacock-Farrell in penalty shootout action against Bosnia in last month’s semi-final “It has the potential to be one of the best nights that probably half the squad get to experience, obviously the other half have done Greece and have that memory, that experience in the bank,” the Burnley goalkeeper said.“That’s going to play a big part in Thursday, and, obviously [for] the lads like myself who weren’t in the squad in 2016, it certainly would be up there with one of the best things so far.” Former Northern Ireland goalkeeper Roy Carroll says Jonny Evans can make a ‘big difference’ if he’s fully fit for the Euro 2020 play-off against Slovakia on Thursday – Advertisement – 0:25 As they seek to emulate the achievements of the Michael O’Neill era, which saw the country reach the last 16 of Euro 2016, Peacock-Farrell is fully aware of what a win would mean.The 24-year-old does, however, believe home advantage could be pivotal for Northern Ireland.Just over 1,000 fans are expected to attend the match in a socially-distanced capacity at Windsor Park, following on from the 600 who were there for the Austria game last month. Peacock-Farrell hopes they can lean on that experience within the squad as they prepare for their winner-takes-all clash. “We are good, we are looking forward to it,” Peacock-Farrell said.“We are obviously aware of how hard it is going to be, the difficulty of the game, and obviously the emotional aspect of it is getting to the Euros so the stakes are high.“But at the end of the day, it’s just a game of football and we are at home which is a massive advantage for us.“Obviously as a footballer you dream of those situations and you hope to be there.“Now we have got that chance, I have got the chance to achieve that with a win on Thursday night.“Not trying to get ahead of ourselves and things like that, but as a footballer you want to be at those major tournaments and Thursday night is the path to get there.”Magennis: There will be tears if Northern Ireland reach Euros 0:47 Bailey Peacock-Farrell has billed Northern Ireland’s European Championship play-off final against Slovakia as having the makings of one of the country’s greatest nights.Northern Ireland know a win at Windsor Park on Thursday will book their place in next summer’s re-arranged Euros, four years after they ended a 30-year wait for a major tournament appearance at Euro 2016.- Advertisement – Ian Baraclough’s side had to hold their nerve in last month’s qualification semi-final, where they beat Bosnia on penalties. 0:27 Bailey Peacock-Farrell says the 1,000 fans with help Northern Ireland create a home advantage in their Euro qualifier against Slovakia Josh Magennis says there will be tears if Northern Ireland beat Slovakia on Thursday to book their place at next summer’s European Championships.Victory would take them to their second consecutive Euros, and their second major finals in the 34 years since reaching the 1986 World Cup.Hull City striker Magennis is under no illusions as to the significance of what qualification would mean for the country. – Advertisement – Image:Josh Magennis believes qualification would be just as good as the first time they qualified for the Euros four years ago – Advertisement – “It would be absolutely massive,” said Magennis who was a part of the Northern Ireland squad at the 2016 finals.“To say you got to one major tournament is beyond believable, to say if you were able to get to two, to go to both, it will be class.“There will be as much tears as there was the first time, so it will be amazing.“If you need any more inspiration or you need to get yourself geed up for these games, then I think you are in the wrong sport.”
MIAMI — A high school principal in Florida whose refusal to acknowledge the Holocaust as a “factual, historical event” in an email led to a national backlash, his firing and then his rehiring has been fired for a second time.The Palm Beach County school board on Tuesday voted 7 to 0 to fire the principal, William Latson, who was removed from his post last year at Spanish River Community High School in Boca Raton, Fla., after a 2018 email exchange with a student’s parent became public.- Advertisement – A lawyer for Mr. Latson did not immediately respond to a request for comment on Wednesday.- Advertisement – Mr. Latson, who has worked for the district for 26 years, oversaw Spanish River High until he was reassigned in July 2019, after his remarks in an email with a parent drew a national uproar.“I can’t say the Holocaust is a factual, historical event because I am not in a position to do so as a school district employee,” Mr. Latson stated in one of the emails, which were obtained by The Palm Beach Post. Mr. Latson said he had to stay “politically neutral” and separate his personal views about the Holocaust from his job as a public school official.“I do allow information about the Holocaust to be presented and allow students and parents to make decisions about it accordingly,” he wrote. “I do the same with information about slavery.”- Advertisement – In August, Judge Robert S. Cohen concluded that Mr. Latson should have been reprimanded or reassigned to another position at the Palm Beach County school district, but not fired.The judge said that Mr. Latson had “engaged in misconduct in office, incompetence or gross insubordination by a preponderance of the evidence.”During a school board meeting on Oct. 7, callers, including Jewish people and relatives of Holocaust survivors from around the country, requested in recorded messages that the school board not reinstate Mr. Latson.At the meeting, which was two months after the judge issued his recommendation, the school board voted 4 to 3 to reinstate the principal.The rehiring stirred up another outrage. Richard Corcoran, the Florida education commissioner, called for the immediate cancellation of Mr. Latson’s professional educator certificate.The school board took up Mr. Latson’s rehiring again last month. School board members delayed a decision scheduled for Oct. 21 so they could listen to more than 20 hours of public comment.Before the rescheduled vote, Mr. Latson released a three-minute video in which he apologized to the district and community. In a revised final order approved on Tuesday, the school board said that “Dr. Latson’s actions did rise to the level of gross insubordination.”“Dr. Latson did commit misconduct in office, incompetency and gross insubordination, providing just cause for his suspension and termination,” the board added. – Advertisement – “I am not a Holocaust denier,” he says in the video. “I have never been a Holocaust denier. I am sorry that my comments caused people to think that.”On Nov. 2, the school board rescinded its previous vote and on Tuesday, the board approved a revised final order to terminate Mr. Latson’s employment.Mr. Latson can appeal the ruling to Florida’s Fourth District Court of Appeal, according to The South Florida Sun Sentinel. News of Mr. Latson’s emails drew outrage, particularly in South Florida, which has a large Jewish population.In October 2019, the school board voted 5 to 2 to fire Mr. Latson, who requested a hearing before a judge. The case moved to the Division of Administrative Hearings in Tallahassee, Fla.
Aug 24, 2004 (CIDRAP News) – Chinese health officials confirmed yesterday that H5N1 avian influenza had been found in pigs there in 2003 but says no such findings have occurred in 2004. They also stated that the occurrence had been made public earlier in the year, although the UN Food and Agriculture Organization (FAO) says there has been no official report of the disease in pigs.The Chinese ministry of agriculture in a press release stated that, spurred by the widespread outbreaks of avian flu in Asia earlier this year, they have tested 1.1 million samples from poultry and some samples from pigs and that no H5N1 has been found in pigs, Chinese news agency Xinhau reported. The agency said also that the 2003 finding of the virus in pigs had been made public earlier this year. It turns out that an article reporting the findings appeared in the January issue of the Chinese Journal of Preventive Veterinary Science and another in the May issue. The latterreported that the virus was found in April 2003 in pigs at four locations near the east coast of China. The articles are in Chinese; translation for FAO and the World Health Organization (WHO) is under way.Confusion began when a prominent Chinese avian influenza expert, Chen Hualan, an author of the two studies, said in a presentation at an international meeting late last week that the H5N1 virus had been found in pigs in China in both 2003 and 2004, to the surprise of WHO and FAO officials who were not aware of this. A New York Times story says a press official of the Chinese health ministry was likewise surprised when told later of the expert’s comments and that he said his office had no information on the subject. It is unclear whether Chen’s remarks had been officially authorized.The state-run Beijing Times ran a story today saying that Chen, after several days of silence, called the amount of avian flu virus in the pigs “extremely small,” with the probability of isolating H5N1 from the animals “less than one in a thousand,” according to an AFP story. The story also stated that an unnamed spokesperson for the ministry of agriculture said “some experts’ remarks” were at odds with the government’s view of events.FAO official Juan Lubroth said several details about the cases in pigs, including whether the animals in which H5N1 was found became sick, are crucial, the New York Times story says. If the pigs did not become ill, he explained, they would be harder to detect and quarantine or destroy, although this might also indicate that the virus had lost some of its potency. The WHO in a statement on its Web site points out the importance of comparing the H5N1 isolated from pigs with the strain isolated from poultry to determine whether the virus was passed directly from poultry to pigs. Shigeru Omi, WHO regional director for the Western Pacific, told AFP that “We have asked [Chinese officials] for information, but so far there have been no additional details. Overall the Chinese government has been cooperative and I hope they will remain so.”In other developments, the state-run Thai News Agency reported the August death of a dozen pigs in a northern province, according to a Xinhau story. The animals reportedly had symptoms of coughing, breathing difficulty, and swelling eyes. Chickens on the same farm had died earlier of avian flu, the story says. This report has not been confirmed.In Malaysia, the recent outbreak of avian flu in poultry appears to be restricted to the small village in the northern state of Kelantan where it was confirmed last week, according to the health ministry there. Testing of birds within a 6-mile radius of the village continues, however, and all humans newly suspected of having the disease, including a veterinarian and her three children, have been cleared, according to Reuters. The European Union extended its ban on bird products from several other Asian nations to include Malaysia yesterday, however, and said its ban will stay in force through at least Dec 15, an EU Business story says. Malaysia has been commended by WHO for its prompt action in containing the outbreak.In Viet Nam, 10 of the 11 provinces with re-emergent avian influenza earlier this summer have been free of any new outbreak for 21 days, allowing them to declare themselves free of the disease, according to the Vietnam News Agency. The country will continue to inspect imports and exports of poultry and poultry products and will inspect poultry breeding farms near earlier outbreaks.See also:WHO Aug 20 statement on avian flu in Chinahttp://www.who.int/csr/don/2004_08_20/en
Sep 20, 2007 (CIDRAP News) – BioCryst Pharmaceuticals, Inc, yesterday announced disappointing early results in a phase 2 study of its antiviral drug peramivir, which is seen as a potential new weapon against influenza.Peramivir is a neuraminidase inhibitor that, unlike the licensed antivirals oseltamivir (Tamiflu) and zanamivir (Relenza), is given by intravenous (IV) or intramuscular (IM) injection. Many countries have stockpiled oseltamivir, an oral drug, and zanamivir, inhaled as a powder, in the hope that they will help if the H5N1 virus evolves into a human pandemic strain.The phase 2 double-blind, placebo-controlled trial was designed to see if high doses of IM peramivir could reduce the duration of symptoms in patients with seasonal flu, BioCryst reported in a press release. The study involved 344 patients who had flu that was verified by rapid antigen testing. Patients were randomly assigned to receive injections of a placebo or either 150 mg or 300 mg of peramivir, administered in a single dose within 48 hours after symptom onset.With 313 patients available for evaluation, researchers found that the peramivir group improved more than placebo group, but the difference was not statistically significant, BioCryst reported. The improvement over placebo was 22.9 hours in the 150-mg dose group and 21.1 hours in the 300-mg group.The company said it believes the results were negatively affected by shorter needles—used for the phase 2 study but not for the phase 1 study—that may have delivered an adequate injection to only a third of the volunteers.In a post hoc analysis of 101 patients who received an adequate IM peramivir injection, as measured by elevated serum creatine kinase over baseline, investigators found that improvement over placebo was 64.6 hours in the 300-mg dose group and 44.6 hours in the 150-mg group.Safety and tolerability were similar for the placebo group and both peramivir groups, BioCryst said.”We’re clearly disappointed that we did not achieve the primary endpoint across the entire study population,” said Jon P. Stonehouse, president and chief executive officer of BioCryst, based in Birmingham, Ala., in the statement. However, he added the company was buoyed by the safety findings and said the efficacy findings in the patients that received an adequate dose exceeded expectations.BioCryst will correct the problems identified in the study when it launches a phase 3 study by the end of the year, he said.Another phase 2 study is under way to evaluate the efficacy of IV peramivir in hospital patients with flu, the company said. The study is designed to compare IV peramivir with oral oseltamivir.In January 2006 the US Food and Drug Administration (FDA) granted BioCryst a fast-track designation to develop an injection to treat highly virulent, life-threatening strains of influenza, the company said in its statement. In January 2007 the Department of Health and Human Services (HHS) awarded the company a $102.6 million contract to develop peramivir for seasonal and pandemic influenza.See also:Sep 19 BioCryst press releasehttp://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=264815Oct 2, 2006 CIDRAP News story “Injectable drug seen as potential treatment for flu, both seasonal and avian”
Editor’s note: This is the third in a seven-part series investigating the prospects for development of vaccines to head off the threat of an influenza pandemic posed by the H5N1 avian influenza virus. The series puts promising advances in vaccine technology in perspective by illuminating the formidable barriers to producing large amounts of an effective and widely usable vaccine in a short time frame. Part 2 discussed the huge gap between current global vaccine production capacity and the likely demand for vaccine in the event of a pandemic. Oct 29, 2007 (CIDRAP News) – Many of the difficulties facing achievement of a pandemic influenza vaccine could not have been anticipated before the pandemic threat arose: They are intrinsic to the H5N1 virus itself.Some are obvious. Because all flu viruses mutate rapidly, antigenic drift and division into clades, or subgroups, has already rendered some early vaccine candidates less potent against circulating strains (see Bibliography: Smith 2006, Riley 2007). Because this flu virus is highly pathogenic, it must be handled initially in one of a relatively small number of high-biosecurity laboratories (see Bibliography: WHO 2004) and also requires the use of reverse genetics to create a seed strain that will reproduce in eggs. Reverse genetics and the stringent pre-release testing that follows add a minimum of 6 weeks to the vaccine production process (see Bibliography: Wood 2007: Reference viruses). And absent regulatory changes, the resulting seed strain could be considered a genetically modified organism under European Union rules or a select agent under US law, further restricting the laboratories, personnel, and manufacturers who could work with it from then on (see Bibliography: Stephenson 2006: Development and evaluation).Reverse genetics may be responsible for a phenomenon noted by several researchers: H5N1 does not reproduce well in vitro, a potentially major obstacle for vaccine production because it would greatly lengthen the manufacturing timeline. “Most manufacturers report that yields of antigen from reverse genetics–derived H5N1 viruses are 30-40% of the average of seasonal influenza viruses, reducing the quantity of antigen available for vaccine formulation,” Iain Stephenson of University Hospital-Leicester and colleagues wrote last year in Lancet Infectious Diseases (see Bibliography: Stephenson 2006: Development of vaccines).Vaccines show poor immunogenicityFurthermore, when candidate vaccines have been produced from them, H5N1 and similar viruses have not done a good job of provoking an immune response. This was noted as early as 1998, when an early attempt to create a vaccine in the wake of the 1997 Hong Kong outbreak used an antigenically similar H5N3 strain—only to find it was poorly immunogenic even at the highest concentration of two 30-microgram (mcg) doses (see Bibliography: Nicholson 2001). There were similarly poor results in 2006 and 2007 trials that used an H5N1 strain isolated from Vietnam in 2004 and modified by reverse genetics (see Bibliography: Bresson 2006, Leroux-Roels 2007): Even at the highest dosage given (two 30-mcg doses), neither trial induced levels of immune protection that would be acceptable to the Food and Drug Administration (FDA) or the European Union’s Committee for Medicinal Products for Human Use (CHMP).But the best example of H5N1’s poor immunogenicity is the 2006 trial that led to the first FDA licensing of an H5N1 vaccine. The trial, which used the same modified 2004 Vietnam strain as the others, achieved acceptable levels of protection only at the highest amounts given, two doses of 90 mcg each, or 12 times the 15-mcg dose that induces immunity in a seasonal vaccine (see Bibliography: Treanor 2006: Safety and immunogenicity of an inactivated subvirion influenza A [H5N1] vaccine). Even at that dosage, only 54% or 58% of the subjects (by two different measures) exhibited antibody titers that matched FDA and CHMP regulations, compared with the 70% to 90% usually achieved with seasonal vaccine (see Bibliography: CDC 2005).The trial’s investigators acknowledged that the extraordinarily high dose necessary to protect was an unsatisfying result, saying, “The need for a vaccine with a total dose of 180 mcg would pose a considerable barrier to rapid production of a supply that would be adequate to meet the world’s requirements should a pandemic occur” (see Bibliography: Treanor 2006: Safety and immunogenicity). Experts who reviewed the data during FDA deliberations on licensure agreed, signaling that they hoped for improved results as research advances. “There are numerous vaccines under development that are potentially better, if you will, than this vaccine. This is an interim vaccine,” Norman Baylor, PhD, director of the FDA’s Office of Vaccines Research and Review, said during the FDA hearing (see Bibliography: FDA 2007: Committee meeting transcript).The amount of antigen needed in that vaccine concerns researchers several times over. It is so high that the vaccine would stress the manufacturing system if put into broad production, although regulators at the licensure hearings said the vaccine is intended only for federal stockpiling and not for commercial sale. In addition, they fear the high dose—which at 180 mcg total is four times the total seasonal trivalent dose—could provoke an unusual rate of adverse reactions (see Bibliography: FDA 2007: Committee meeting transcript).(Regulators may be quietly bracing for adverse publicity as well. Testimony at the same FDA committee meeting indicated that, because of limitations on fill/finish capacity, the 90-mcg vaccine being manufactured for the US stockpile will be packaged in multi-dose vials which, to guard against contamination, will contain the still-controversial preservative thimerosal.)Immunity hard to measureThe 2006 trial’s unsatisfying results highlighted a chronic concern in flu-vaccine research: the lack of reliable correlates of immunity for pandemic vaccines. Given the lack of a vaccine, moderate antiviral resistance, and a case-fatality rate of more than 60%, humans cannot ethically be experimentally exposed to the H5N1 virus. Yet none of the animal models—mice, ferrets, or the recently proposed guinea pigs (see Bibliography: Lowen 2006)—is a perfect substitute. Hence the research community relies instead on measures of human antibody response that are neither uniform across laboratories nor universally agreed to by regulatory bodies.”I think this is our biggest scientific issue—that we are not sure what the appropriate surrogate for protection is, given the fact we have no ability to challenge [expose humans] and are not likely to,” said flu epidemiologist Dr. Arnold Monto of the University of Michigan (see Bibliography: Monto 2007).In the United States, the FDA-accepted surrogate for immunity in flu-vaccine trials is a hemagglutination-inhibition (HI) antibody assay that returns a post-vaccination titer of more than 1:40 for 70% of those vaccinated (see Bibliography: FDA 2007: Guidance for industry: clinical data needed to support the licensure of seasonal inactivated influenza vaccines). But that measure is known to be imperfect even for seasonal flu: Patients with higher titers have contracted flu, while those with lower post-vaccination titers have apparently been protected (see Bibliography: Poland 2006). Additionally, the HI test appears in the lab to be less sensitive to H5 antibodies than it is to the seasonal strains H1 and H3; a second test, virus microneutralization, appears more sensitive but also has no agreed-upon clinical correlates (see Bibliography: Stephenson 2004). Researchers have resorted to using a 1:40 result as the best available measure of immunologic response, while conceding that it may not indicate actual degrees of protection.”It’s important to understand that this choice of a 1:40 endpoint is not validated in any way as an actual assessment of protection against H5 in humans,” Dr. John Treanor of the University of Rochester, principal investigator for the trial that produced the licensed H5 vaccine, said at the FDA licensure hearings. “It might be just as valid to choose a 1:20 or a 1:80 or a 1:10 endpoint. But it’s really more a convenient way in order to discriminate responses between groups” (see Bibliography: FDA 2007: Committee meeting transcript).Unfortunately, HI titer results vary wildly. In two studies, European labs performing the same test for seasonal flu strains returned results that varied from 16- to 128-fold, and for H5N1, labs have achieved different results depending on the source and age of the animal cells used in the assay (see Bibliography: Wood 2007: International standards). The WHO is pursuing international agreement on a standard for H5N1 tests, similar to standards achieved earlier for measles, polio, rubella, and other infectious diseases.But the problem with finding correlates of immunity goes further. The HI test may not return reliable results for vaccines that provoke types of immunity other than antibody response. That makes it an unreliable measure for the effectiveness of two promising alternative classes of vaccines: live-attenuated vaccines, which have the potential to generate immunity against multiple strains of flu, and inactivated adjuvanted vaccines (those containing a chemical immune-system stimulant), which could help solve the supply bottleneck by allowing much smaller amounts of antigen to be dispensed in each vaccine dose (see Bibliography: Subbarao 2007, Wood 2007: Author interview). The pandemic vaccine puzzlePart 1: Flu research: a legacy of neglectPart 2: Vaccine production capacity falls far shortPart 3: H5N1 poses major immunologic challengesPart 4: The promise and problems of adjuvantsPart 5: What role for prepandemic vaccination?Part 6: Looking to novel vaccine technologiesPart 7: Time for a vaccine ‘Manhattan Project’?Bibliography
Nov 9, 2007 (CIDRAP News) – Officials in Vietnam recently reported H5N1 avian influenza outbreaks at farms in two more provinces, bringing to six the number of provinces hit by the virus since early October.On Nov 7, the agriculture ministry confirmed the H5N1 virus in samples from a flock of 2-month-old ducks at a farm in Ha Nam province in the northern part of the country, Reuters reported yesterday. The ministry’s report also said the virus was found in two dead chickens that were dumped in a river in the province.Today the agriculture ministry reported another H5N1 outbreak in Ben Tre province, in southern Vietnam, China’s state news agency Xinhua, reported. The outbreak killed half of a 60-bird flock of 2-month-old ducks, the report said.Recent outbreaks have also been reported in Cao Bang and Nam Dinh in the north, Quang Tri in the central part of the country, and Tra Vinh in southern Vietnam, according to previous reports from the World Organization for Animal Health (OIE). All involved unvaccinated ducks.In other developments, a United Nations (UN) official today cautioned Asia to be watchful for a sharp rise in avian flu outbreaks as winter approaches, the Associated Press (AP) reported.”The northern winter seems to be a time when the risk of the disease in poultry increases, and it’s partly to do with the facts that this virus quite likes the cold weather,” David Nabarro, the UN’s coordinator for avian flu, told the AP.He said birds migrating from Asia to the south and west in the winter could carry the disease to new areas, the AP reported.Vietnam has not reported a human H5N1 case since August. With 100 cases and 46 deaths, the country is the world’s second hardest hit country by avian flu, behind Indonesia.See also:OIE reports on 2007 Vietnam outbreaks
Second, the group says Congress should give the HHS secretary more authority and better legal tools to ensure that food companies use contamination-prevention controls and meet food safety performance standards. Congress should empower HHS to access company food safety records, order food recalls, enact user fees for food facilities to boost safety, set performance standards, and require traceability of food. The report, “Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the US Department of Health and Human Services,” renews and amplifies recommendations that TFAH made in a report a year ago. (See Apr 30, 2008, CIDRAP News story.) The new report was prepared in collaboration with the Robert Wood Johnson Foundation. The report also calls for increasing the FDA’s food safety funding and giving it greater authority to require food companies to embrace sound prevention systems. In addition, it calls for a closer partnership between the FDA’s food safety programs and the food safety epidemiology program at the Centers for Disease Control and Prevention (CDC). TFAH calls for three other immediate steps, besides appointing a food safety administrator. One is to double the funding for HHS food safety programs over the next 5 years, including both the FDA and CDC programs. Consumer group supports proposalThe TFAH recommendations, especially the proposals to put food safety under one person and in a separate agency, were welcomed by the Consumer Federation of America (CFA). In the wake of recent major foodborne disease outbreaks, including the nationwide Salmonella outbreak tied to peanut products, the time is ripe for food safety policy changes, TFAH officials said. “I actually think we’ve reached a tipping point, now that there’ve been a series of crises and now in the peanut incident a bad actor and therefore a recognition that we need stronger government authority,” said Levi. “I think that created the political will for the Congress to act and the administration to move more rapidly.” “Over time, we want to see taking the ‘F’ out of FDA and creating a separate Food Safety Administration,” said Levi. “This will ensure food safety gets the attention it deserves.” Mar 25, 2009 (CIDRAP News) A public health policy group today urged the government to put one person in charge of all food safety efforts at the Food and Drug Administration (FDA) as a first step toward preventing the kinds of foodborne disease outbreaks that have plagued the nation in recent years. The TFAH plan does not call for the FSA to take over the CDC’s food safety functions, but it does envision “an active partnership” with the CDC. In this plan, the CDC would receive FDA funds in return for providing the data and analysis needed by the FSA, the report says. For one of the next steps, the nonpartisan Trust for America’s Health (TFAH) said in a report released today, Congress should put the FDA’s food safety programs in a proposed new “Food Safety Administration” (FSA) within the Department of Health and Human Services (HHS), thus splitting the FDA into separate food and drug agencies. The new agency would have one administrator, but the proposal also calls for creating a Leadership Council to make strategic plans, set agency-wide priorities, and allocate resources, according to the report. “Our goal with this report is providing a road map for the first steps in reforming the food safety system,” TFAH Executive Director Jeffery Levi said at a press teleconference today. Setting up a new agencyTFAH proposes the FSA as a “medium-term” step to raise the profile of food safety at HHS. The food agency would be created by separating the FDA’s food functions from its medical product functions, with the latter moving to a new “Federal Drug and Device Administration.” Third, states should be “encouraged and incentivized” to adopt and comply with the FDA Food Code and the National Retail Food Regulatory Program. See also: The HHS secretary has “ample authority” to put one administrator in charge of the FDA food programs, the report says. It says the existing structures of CFSAN and CVM could be maintained until the proposed separate food safety agency is set up. In addition, Rep. John Dingell, D-Mich., has introduced a bill that would impose user fees on food facilities, set safety standards for produce, and mandate food traceability, the report notes. He also said such changes could help strengthen food safety efforts at the state and local levels. “This structural reform puts a single person in charge of food safety at HHS, so that person can better deploy resources and create better systems in terms of how the federal government interacts with the states and locals on food safety,” he said. Seeking a food safety administratorThe report notes that the FDA has several units that deal with food safety, including the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Office of Regulatory Affairs (ORA), and the Office of Food Protection. “There is no FDA official whose full-time job is food safety and who has line authority over food safety efforts as a whole,” said Taylor. Noting that the FDA commissioner is in charge of responsibilities for drugs and medical products as well as food, he added, “The practical result is that no one is really in charge and realistically accountable for the success or failure of FDA food safety programs.” CFA spokesman Chris Waldrop said the FDA needs more resources and stronger laws, “but you won’t be able to take full advantage of those things if you don’t change the structure within HHS and give the food safety function more authority.” Proposed legislationSeveral bills pending in Congress have elements that fit TFAH’s recommendations, according to the report. TFAH says the oft-mentioned idea of consolidating all federal food safety efforts into one agency should be considered by Congress as a long-term goal. This would mean combining the FDA’s food programs, the meat safety programs of the US Department of Agriculture, and food safety activities of the Environmental Protection Agency. “With the public scrutiny on the issue, if we’re not going to do food safety reform this year, and specifically the first half of this year, it’s hard to say when we’re going to do it,” said Michael R. Taylor, JD, a professor of health policy at George Washington University who worked with TFAH on the report. He is a former deputy commissioner for policy at the FDA. The new food agency would include the functions and resources of CFSAN and CVM as well as the food-related functions of the ORA and the FDA Office of the Commissioner, the report says. It would also incorporate the National Center for Toxicological Research. The proposed structure would consolidate the scientific divisions of CFSAN and CVM into one unit. Similarly, it would combine the compliance and enforcement elements of CFSAN, CVM, and relevant parts of the ORA in a single entity. “This would put more resources into the badly underfunded food safety program at CDC, and it would create a contractual, client-service provider relationship in which FSA’s information needs and CDC’s accountability for meeting them would be clear,” the document states. It says that a bill offered by Rep. Rosa DeLauro, D-Conn., would create a new food safety administration within HHS and would modernize the food safety law that governs the FDA. Another bill, sponsored by Sen. Richard Durbin, D-Ill., and several others, would require more preventive controls and give HHS more authority to regulate food. Mar 25 TFAH news releasehttp://healthyamericans.org/report/62/food-safety-2009
(CIDRAP Business Source Osterholm Briefing) – Big news today: The World Health Organization (WHO) ended days of speculation and finally bumped the pandemic alert level to phase 4. What’s more, it did so after releasing revamped definitions and meanings yesterday.Your head may be spinning at the moment, so let’s take a deep breath and make sense of all the news today. As you may recall, the first pandemic phase alerts were released in 1999, then revised in 2005. A draft of the current changes was released last October.How have the phases changed?The WHO describes six phases and has added a “post peak period” and a “post pandemic period.” The way they’re grouped and the descriptions of each phase have changed. According to the WHO’s guidance on how to use the new phases, the revisions make them “easier to understand, more precise, and based on observable phenomena.”The five new groupings of phases are the following:Predominantly animal infections; few human infections (phases 1-3)Sustained human-to-human transmission (phase 4)Widespread human infection (phases 5-6/pandemic)Possibility of recurrent events (post peak)Disease activity at seasonal levels (post pandemic)Here’s how the old (2005) and the new (2009) versions compare:Phase 1Old: Low risk of human casesNew: No animal influenza virus circulating among animals have been reported to cause infection in humansWhat’s changed: More specificityPhase 2Old: Higher risk of human cases; considered a “new virus in animals, no human cases” phaseNew: An animal influenza virus circulating in domesticated or wild animals is known to have caused infection in humans and is therefore considered a specific potential pandemic threatWhat’s changed: More specificityPhase 3Old: No or very limited human-to-human transmission (considered a “pandemic alert” phase)New: Animal or human-animal influenza reassortant virus has caused sporadic cases or small clusters of disease in people, but has not resulted in human-to-human transmission sufficient to sustain community-level outbreaks; considered a phase described as “predominantly animal infection; few human infections”What’s changed: A “pandemic alert” phase has been removed.Phase 4Old: Evidence of increased human-to-human transmissionNew: Human-to-human transmission of an animal or human-animal influenza reassortant virus able to sustain community-level outbreaks has been verifiedWhat’s changed: We now have a benchmark by which we can determine what increased human-to-human transmission actually means. There must be sustained outbreaks in the community.Phase 5Old: Evidence of significant human-to-human transmissionNew: The same identified virus has caused sustained community-level outbreaks in two or more countries in one WHO regionWhat’s changed: Now it is necessary to have the level of infections that is currently occurring in Mexico (ie, found in two or more countries). This gives another benchmark that is much more specific than what was found in the old definition.Phase 6Old: Efficient and sustained human-to-human transmissionNew: In addition to the criteria defined in phase 5, the same virus has caused sustained community-level outbreaks in at least one other country in another WHO regionWhat’s changed: Not much. The pandemic is well under way.New: Post peak periodLevels of pandemic influenza in most countries with adequate surveillance have dropped below peak levels.New: Post pandemic levelLevels of influenza activity have returned to the levels seen for seasonal influenza in most countries with adequate surveillance.What do the changes mean to you?I’ll be brief here. Before the update, phase 4 put us on high alert and gave us time to activate our plans—if we had them. The new phase 4, which requires significant human-to-human transmission at the community level, means the stakes are much higher when we reach this point. And if we haven’t planned, we have to scramble. Preparation per se is a thing of the past.So what should you do now that phase has been elevated?So much remains uncertain about this new virus. But as we mentioned in the last Special Edition of Osterholm Briefing, it’s time to activate your plan. And if you don’t have a plan, again I’ll refer you to the list of seven actions (question 4) mentioned in that column. It’s not too late to do something, including notifying senior management how urgent the need is now.At the same time, I cannot emphasize enough how important it is to realize that this outbreak could go any number of ways. It could turn into a full-blown pandemic any day now. It could disappear soon, only to reappear later. Or it could fizzle altogether. We just don’t know, and it’s important to communicate that point frankly. It’s also important to never forget that if this new H1N1 swine flu virus doesn’t cause the next pandemic, another influenza virus some day will do so.And what about traveling?There’s been considerable confusion about the difference between “containment” and “transmission.” Here’s the straight story. The swine flu outbreak cannot be contained; it has already leaked out of Mexico to the rest of the world. The possibilities for containment are long gone. However, we can take actions to reduce the transmission of the virus between people. Take a look at the resources posted in the Employee Protection section of the Source Web site for a full range of options.As for traveling, the WHO as I write this has not advised restrictions on regular travel or the closure of borders. The CDC, however, just recommended that US travelers avoid all nonessential travel to Mexico out of concern that travel to Mexico “presents a serious risk for further outbreaks of swine flu in the United States.” The CDC is also recommending that travelers stay informed, follow local public health guidelines including any movement restrictions and prevention recommendations, and be aware that Mexico is checking all exiting airline passengers for signs of swine flu. Such exit screenings may cause significant delays at airports. In the travel advisory, CDC also makes recommendations regarding antiviral medications. I encourage you to review these. Few if any pandemic exercises or drills have occurred without such actions being envisioned. If you want to cut down on nonessential travel to places besides Mexico, this seems appropriate at this time.Bottom line for businessThese new phases are meant to help direct the governments of the world with regard to public health action, allocation of resources, and as a measure of disease level. And they clearly give the private sector more understandable trigger points for implementing preparedness plans. We consider them zones for preparedness that ensure a certain level of safety. In other words, simply because it took years to move from the old phase 3 to new phase 4, we can’t expect it will take as many or more years before we see another phase change.It might take only days to move to the next phase. Stay tuned.
May 18, 2009Japan reports spike in novel H1N1 casesHealth officials voiced concern over a surge in novel H1N1 influenza cases in Japan, particularly among young people, Agence France-Presse (AFP) reported today. Case numbers rose from 4 to 129 over the weekend, leading to more than 2,000 school closures. Many of the new cases are reported from Kobe and Osaka, where officials believe the virus spread during a high school volleyball tournament. Community spread in a region outside of North America could trigger a rise in the world’s pandemic alert level.Global cases rise, six countries report first casesThe global number of novel H1N1 cases pushed to 8,829 in 40 countries, the World Health Organization (WHO) reported today. The count includes 3,103 cases and 68 deaths in Mexico, 4,714 cases and 4 deaths in the United States (as of May 15), 496 cases and 1 death in Canada, and 9 cases and 1 death in Costa Rica. Countries reporting their first cases over the past few days include Ecuador, Peru, India, Malaysia, Turkey, and Australia.[WHO update 32]New York death boosts US fatalities to 6An assistant principal at a New York City school shuttered by with a high rate of novel H1N1 infections died last night, raising the number of US deaths from the disease to six, the New York Daily News reported today. The 55-year-old man died 6 days after he became ill. His family said his only underlying condition was gout. The man reportedly received an experimental modality using ultraviolet rays to decrease pathogens in the blood. Other outlets reported he was also treated with ribivirin.[May 18 Daily News report]US cases pass 5,000The number of US confirmed and probable novel H1N1 cases grew to 5,123, of which 5 were fatal, from 48 states and the District of Columbia, the US Centers for Disease Control and Prevention (CDC) reported today. The total includes the first reported cases from Mississippi. The only states with no confirmed cases are Alaska, West Virginia, and Wyoming. Yesterday’s death of a New York man from the new virus is not yet included in the CDC’s total.[Current CDC numbers]CDC reports unusual trends involving young patientsAt today’s CDC press briefing, Anne Schuchat, MD, from the science and public health program, said some unusual patterns are emerging with the novel H1N1 virus in young people. Officials have already noted that the new virus has disproportionately affected younger people, she said. However, she specified that hospitalizations are primarily occurring in those 5 to 24 years old. Also, Schuchat said the number of school closures this late in the season in diverse parts of the country is also unusual.[May 18 CDC briefing transcript]Virus-like particles show promise for use in flu vaccinesVirus-like particles—noninfectious viral “shells”—produce a robust immune response against flu and could be used in a vaccine, Ted Ross, PhD of the University of Pittsburgh’s Center for Vaccine Research said today at the American Society for Microbiology’s general meeting. Ross and colleagues have used VLPs made from H5N1 avian flu and the reconstituted 1918 pandemic flu virus in early clinical trials. The particles can be produced faster than traditional vaccines, Ross said in an interview.No evidence of a second novel H1N1 strainIn response to a reporter’s question at a CDC press briefing on May 15, a CDC official said the agency was investigating reports that another novel H1N1 virus had been identified in Mexico. Later that evening, Nancy Cox, MD, head of the CDC’s influenza division, told Science Insider blog that the report was rumored and may be a misinterpretation of lab data by someone without lab training. Mexican lab officials told the blog there was no evidence of a second novel H1N1 virus, though seasonal strains were predominant in some parts of the country.[May 15 Science Insider blog post]