May 4, 2005 (CIDRAP News ) – With a federal judge’s permission, the US Department of Defense (DoD) has announced it will resume giving anthrax shots to military personnel, but on a strictly voluntary basis.The DoD’s mandatory anthrax immunization program had been suspended since October 2004, when US District Judge Emmet G. Sullivan ruled that the Food and Drug Administration (FDA) did not follow proper procedures in approving the vaccine for inhalational anthrax.In January the FDA issued an “emergency use authorization” (EUA) permitting DoD to resume the vaccinations, but only on a voluntary basis. On Apr 6, Sullivan granted a DoD request to resume giving the shots under the terms of the emergency authorization.Yesterday the Pentagon announced it was ready to resume giving anthrax shots. Officials said the vaccinations would mostly be limited to military units assigned to the Central Command area, which includes the Middle East, and to troops serving in Korea and in homeland bioterrorism defense.”The implementing program requires commanders to follow EUA conditions very carefully, providing members of the armed services both education on the program and an option to refuse the vaccination without penalty,” the DoD announcement said.Dr. William Winkenwerder, assistant secretary of defense for health affairs, called the immunization program a “vital protection measure for military personnel, who are at increased risk of exposure to an anthrax attack.”A DoD policy memo about the program says the EUA is scheduled to expire on July 27, less than 3 months away. “At that time, other initiatives may result in resumption of the normal AVIP [Anthrax Vaccine Immunization Program], including mandatory vaccinations for selected personnel,” the memo says. “Alternatively, the EUA may be extended or other direction may be provided.”Perry Bishop, a Pentagon spokesman, said DoD will continue to press for mandatory vaccination, according to an Associated Press report published yesterday.The DoD memo says all personnel eligible for anthrax vaccination must be told they may refuse the shots and will not be punished. Troops must be told they will not be discharged for refusing and they can still be deployed. However, personnel must also be told, “Your military and civilian leaders strongly recommend anthrax vaccination,” the memo states.Personnel will be given a brochure that explains the known and potential benefits and risks of vaccination as well as the alternatives to vaccination.Before Sullivan’s ruling, anthrax shots were mandatory for personnel serving in areas where the risk of anthrax attack was considered high. More than 1.3 million troops had been vaccinated in the program, which began in 1998. But hundreds of troops refused the shots because of concern about side effects, and some were disciplined or discharged from the service.Sullivan’s ruling came in a lawsuit filed by six DoD personnel and civilian contractor employees who objected to the shots. 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. The vaccine was originally licensed in 1970.The FDA responded immediately by declaring that the vaccine was safe and effective for all forms of anthrax. Sullivan then lifted his injunction in January 2004. But in his subsequent ruling in October 2004, Sullivan said the FDA had failed to follow its own rules in declaring the vaccine safe for all forms of the disease.Last December, military officials asked the Department of Health and Human Services (HHS) for emergency authority to resume the vaccination program. Under the Project Bioshield Act of 2004, the FDA, in a declared emergency, can authorize the use of a medical product that has not gained ordinary FDA approval. The FDA then issued the emergency authorization on Jan 27, but said the shots had to be voluntary.The anthrax vaccine used by DoD requires six shots over a period of 18 months, followed by annual boosters. Last November HHS awarded an $877 million contract for a new anthrax vaccine that officials hope will require fewer doses and have fewer side effects, but that vaccine is intended to go in a stockpile for civilian use.See also:May 3 DoD news releaseDoD policy memo
Failed engineering firm Carillion’s dividend disclosures were used as an example of good practice in a report published by the UK’s audit watchdog less than 18 months before the company collapsed.A December 2016 report from the Financial Reporting Council’s (FRC) Financial Reporting Lab singled out Carillion’s 2015 annual report as an example of good practice in dividend disclosure.The Lab noted that Carillion’s disclosure addressed “the factors and risks the board considers in setting the policy”.It highlighted the firm’s discussion of “distributable reserves and cash resources available to support the dividend”. UK politicians have since accused Carillion’s bosses of putting dividends ahead of its pension scheme. Carillion’s annual report for 2016 detailed that it had paid £393.7m (€450.7m) to shareholders since 2012, while making deficit contributions to its defined benefit (DB) schemes of £209.4m in total. Since last year, the UK’s Pensions Regulator has increased its emphasis on companies striking a balance between dividend payments and pension scheme deficit reduction payments.Tim Bush from Pensions & Investment Research Consultants told IPE: “The FRC’s Lab made the fatal error of trying to patch up with disclosure, rather than deal with the core of the problem, which is the numbers being unreliable and wrong.“It has managed to pick losers in a way that would make short sellers envious, but which makes the FRC as regulator an endorser – something it is unwise to do.”The FRC told IPE the Lab Report contained the views of investors, not those of the FRC.FRC criticised by MPs’ committeesMeanwhile, a report into Carillion’s collapse accused the FRC of a “timid” approach to the case. The joint report by the UK parliament’s Work and Pensions and Business select committees found that FRC’s “limited intervention” had failed to deter Carillion from an overly optimistic view of its financial health.It also claimed that the FRC was “happy to walk away after securing box-ticking disclosures of information.”The committees’ report said: “It was timid in challenging Carillion on the inadequate and questionable nature of the financial information it provided and wholly ineffective in taking to task the auditors who had responsibility for ensuring their veracity.”The FRC argued in response that it was “a strong, transparent regulator which makes use of its statutory powers and innovates, for example, by first introducing audit retendering and most recently an extended audit firm monitoring and supervisory approach”. Carillion was involved in the construction of a high-speed rail link between London and ManchesterA review of the FRC’s operations – and potentially its future – is currently underway. The business secretary Greg Clark has appointed former top civil servant Sir John Kingman to head the probe. He is currently taking evidence from stakeholders.At its peak, Carillion employed 43,000 people around the world, with roughly half of them in the UK. Last year it issued three profits warnings before going bust in January – dumping a pension liability estimated at £800m on the Pension Protection Fund, the UK’s defined benefit lifeboat scheme.Watchdog’s culture reviewAhead of the committees report, the FRC released its own Audit Culture Thematic Review last week.It described the study as a “snapshot” of the steps being taken by audit firms “to establish, promote and embed a culture that is committed to delivering consistently high quality audits.”“The FRC’s reports continue to highlight shortcomings of audits and then scandals highlight even more problems”Prem Sikka, University of SheffieldPrem Sikka, a professor of accounting at the University of Sheffield and long-standing critic of international accounting standards, queried why the FRC had published the thematic review ahead of the select committee report.The review said “nothing about the FRC’s own role” in failing to open up audits to public scrutiny, he added.“Which bit of their culture is changing and how?” Sikka said. “The FRC’s annual audit inspection reports continue to highlight shortcomings of audits and then scandals highlight even more problems.”Separately, the report also hit out at the UK government for failing to take decisive action to tackle corporate complacency and wrongdoing.The politicians said: “The government has recognised the regulatory weaknesses exposed by this and other corporate failures, but its responses have been cautious, largely technical, and characterised by seemingly endless consultation.“It has lacked the decisiveness or bravery to pursue bold measures recommended by our select committees that could make a significant difference. That must change.”In response to feedback on a 2016 green paper on corporate governance, the government pledged to bring in legislation requiring companies to explain how their directors comply with section 172 of the Companies Act 2006. This requires directors to have regard to the interests of wider stakeholders such as pension scheme members, employees, and the environment when running their business.