Queen swore an unlegislated unlawful oath in 1953..That proves fraud!

Royal Marriages – Constitutional Issues Standard Note: SN/PC/03417 Last updated: 2 December 2008 Author: Lucinda Maer Section Parliament and Constitution Centre A series of legal restrictions on the religious beliefs which can be held by the spouse of the monarch were introduced following the Glorious Revolution in 1688. The monarch must join in communion with the Church of England, must declare him or herself to be a Protestant, and must swear to maintain the established churches in England and Wales. If he or she wishes to retain the title to the throne they cannot marry a Catholic. And by the same token, marriage to a Catholic automatically excludes anyone from the line of succession. As well as restrictions on the religious beliefs of the spouse of the monarch, The Royal Marriages Act 1772 requires the descendants of George II (other than the children of princesses married into ‘foreign families’) to seek consent of the monarch before marrying. This note sets out the legal and historical background to the restrictions, and considers their application in the case of the marriage of Prince Charles to Camilla Parker Bowles. Other Standard Notes of interest may be: • • • SN/PC/00683, The Act of Settlement and the Protestant Succession SN/PC/00293, Bill of Rights 1688 SN/PC/00435, The Coronation Oath This information is provided to Members of Parliament in support of their parliamentary duties and is not intended to address the specific circumstances of any particular individual. It should not be relied upon as being up to date; the law or policies may have changed since it was last updated; and it should not be relied upon as legal or professional advice or as a substitute for it. A suitably qualified professional should be consulted if specific advice or information is required. This information is provided subject to our general terms and conditions which are available online or may be provided on request in hard copy. Authors are available to discuss the content of this briefing with Members and their staff, but not with the general public. Contents 1 Religious beliefs of the spouse of the monarch 1.1 Relevant statutes The Bill of Rights 1688 Coronation Oath Act 1688 Act of Settlement 1700 Act of Union with Scotland 1706 1.2 2 3 4 Recent examples 3 3 3 3 4 5 5 6 6 9 9 11 The Royal Marriages Act 1772 Attempts to change the law The marriage of Prince Charles to Camilla Parker Bowles 4.1 4.2 Princess Consort The Civil Ceremony 2 1 1.1 Religious beliefs of the spouse of the monarch Relevant statutes A series of relevant statutes sought to ensure the Protestant succession following the Glorious Revolution of 1688. 1 These have a continuing influence on the religion of the spouse of the monarch. The Bill of Rights 1688 This states: And whereas it hath beene found by experience that it is inconsistent with the safety and welfaire of this protestant kingdome to be governed by a popish prince or by any King or Queene marrying a papist the said lords spirituall and temporall and commons doe further pray that it may be enacted that all and every person and persons that is are or shall be reconciled to or shall hold communion with the see or church of Rome or shall professe the popish religion or shall marry a papist shall be excluded and be for ever uncapeable to inherit possesse or enjoy the crowne and government of this realme and Ireland and the dominions thereunto belonging or any part of the same or to have use or exercise any regall power authoritie or jurisdiction within the same… The Act appears to prevent Roman Catholics from becoming the spouse to the monarch. 2 Coronation Oath Act 1688 Where it is quite clear that monarch or heir must not only not be a Catholic but also join in communion with the Church of England, it would seem that the only restriction on the monarch or heir’s spouse is that she cannot be a Catholic. So far as can be seen, the nearest requirement on a Queen consort to be a Protestant is under the Coronation Oath Act 1688. The wording seems to require the same promise of both King and Queen to maintain the established religion. 3 The Act requires the King and Queen to swear, during the coronation ceremony, that they will to the utmost of their power: maintaine the Laws of God the true profession of the Gospell and the Protestant reformed religion established by law [...] and [...] preserve unto the bishops and clergy of this realm and to the churches committed to their charge all such rights and privileges as by law do or shall appertain unto them or any of them. 4 On the other hand, section 4 of the Act appears to detract from this requirement although the wording is somewhat imprecise: 4. Oath to be administered to all future Kings and Queens And ... the said oath shall be in like manner administred to every King or Queene who shall succeede to the imperiall crowne of this realme at their respective coronations by one of the archbishops or bishops of this realme of England for the time being to be 1 2 3 4 In England before 1752, 1 January was celebrated as the New Year festival, but 25 March was the start of the civil or legal year. The Calendar (New Style) Act 1750 introduced the Gregorian Calendar and moved the start of the civil year to 1 January. Therefore the years given in dates for Acts preceding 1752 are often recorded differently – depending on whether the old or new style calendar is used. In this note, the dates used in Halsbury’s Laws of England have been used. For the rest of this note, all references to ‘Catholics’ are references to ‘Roman Catholics’. Coronation Oath Act 1688 (1 Will & Mar chap 6), s 3 Coronation Oath Act 1688 (1 Will & Mar chap 6), s 3 3 thereunto appointed by such King or Queene respectively and in the presence of all persons that shall be attending assisting or otherwise present at such their respective coronations any law statute or usage to the contrary notwithstanding. The 1688 Act included the Queen, since William and Mary ruled as joint monarchs. This joint monarchy was unprecedented in English history and came about as part of unique circumstances. Mary was the sister of James II and her husband was Dutch. As part of the negotiations leading to the Glorious Revolution, William was approached for his opinion. According to the Oxford History of England William made clear to those who sought to bring him to power that he would not be regent or accept a subordinate position to his wife. The history notes “Both William and Mary formally accepted the offer of the throne made to them jointly, and with it the Declaration of Rights”. 5 Therefore as far as a Queen consort or wife of the heir to the throne is concerned, it is only Catholics who are specifically affected. However, if the speculation about the Coronation Oath is justified, there might be women of some Protestant denominations and non-Christian religions who would not wish to promise to maintain the established religion. (There is also the uncertainty over Holy Communion in the coronation service). The coronation oath was not administered to Prince Philip, who is the consort of the current monarch. Only Elizabeth II took the oath. In contrast, the Queen’s parents, George VI and Queen Elizabeth both took the coronation oath. 6 However, it is worth noting that the oath Elizabeth II took was modified without statutory authority. The present Queen swore to govern the peoples of her realms and territories according to their respective laws and customs and to maintain the established Protestant religion in the United Kingdom. 7 If there were doubts about the religious affiliation of the spouse, it would not seem necessary for the spouse to take the formal coronation oath. The fact that the religious affiliation was non-Christian or pagan would not seem to be relevant, since the oath need not be administered to a spouse. Act of Settlement 1700 The Bill of Rights established the succession to the heirs of Mary II, Anne and William III in that order. But by 1700 Mary had died childless, Anne's only surviving child had died and William was dying. The Stuarts still had claims to the throne. The Act of Settlement was passed, devolving the Protestant succession after Queen Anne (assuming no heir) on Princess Sophia the Electress of Hanover and her heirs, who were Protestants. The Act explained that it was “absolutely necessary for the safety, peace and quiet of this realm to obviate all doubts and contentions in the same by reason of any pretended titles to the crown” 8 , This Act in section 2 reiterated the exclusion of Catholics or persons married to Catholics and the requirement for the Coronation oath: 2. The persons inheritable by this Act, holding communion with the church of Rome, incapacitated as by the former Act, to take the oath at their coronation, according to Stat 1 W & M c 6 5 6 7 8 Sir George Clark The Later Stuarts 1660-1714 second edition p145 See Halsbury’s Laws of England Vol 12(1) The Crown, para 20 For further details see Library Note SN/PC/00435, The Coronation Oath Act of Settlement 1700 (12 & 13 Will 3 chap 2), in long title 4 Provided always and it is hereby enacted that all and every person and persons who shall or may take or inherit the said crown by vertue of the limitation of this present Act and is are or shall be reconciled to or shall hold communion with the see or church of Rome or shall profess the popish religion or shall marry a papist shall be subject to such incapacities as in such case or cases are by the said recited Act provided enacted and established. And that every King and Queen of this realm who shall come to and succeed in the imperiall crown of this kingdom by vertue of this Act shall have the coronation oath administered to him her or them at their respective coronations according to the Act of Parliament made in the first year of the reign of his Majesty and the said late Queen Mary intituled An Act for establishing the coronation oath and shall make subscribe and repeat the declaration in the Act first above recited mentioned or referred to in the manner and form thereby prescribed. At first the effect of this was to exclude all members of other churches. However, members of certain other Protestant churches may not now be debarred. Since 1972, by the Church of England’s Admission to Holy Communion Measure, 9 and the [Church of England] Canon (B15A) that followed it, “baptised persons who are communicant members of other churches which subscribe to the doctrine of the Holy Trinity, and who are in good standing in their own Church” shall without further process be admitted to Holy Communion in Church of England churches. This means, for instance, that a Methodist, Congregationalist, Church of Scotland, or Baptist member can take Anglican communion, though a Unitarian (who would reject the concept of the Trinity) could not. Hence in the strict sense of the wording of the Act of Settlement, members of these churches would not now be excluded. Members of Protestant denominations outside the Church of England do not generally object as a matter of faith to its established status and could thus subscribe to the requirements of the Coronation Oath Act 1688. Such a person could therefore “join in communion”, as the words of the statute decree. A Catholic would probably still be affected by this section, additionally to the specific disabilities quoted in s 2, since he or she could not remain “in good standing” in the Roman Catholic Church by taking communion from an Anglican minister. 10 This disability would appear to affect the spouse of a monarch who would be required to take the coronation oath. However, as seen above, the current monarch took a form of the coronation oath which differed in wording from the 1688 Act. Act of Union with Scotland 1706 The position of the established Protestant Presbyterian Church of Scotland was safeguarded in the Act of Union with Scotland. Article II of the Articles of Union reiterated and confirmed the provisions of the Act of Settlement. It would need amendment should the Act of Settlement be abolished or amended. 1.2 Recent examples There are two recent examples where the marriage of someone in line to the throne to a Roman Catholic has resulted in their removal from the line of succession. 11 The Earl of St Andrews and HRH Prince Michael of Kent both lost the right of succession to the throne 9 10 11 GSM no.2, 1972. The canon is reprinted in Canons of the Church of England, 5th ed 1993 (loose leaf publication) With certain minor exceptions, [RC] Canon 844; Code of Canon Law, 1997 ed. A list of the first 40 in line to the throne is available at http://www.royal.gov.uk/output/page5655.asp (last viewed 22 August 2008) 5 through marriage to Roman Catholics. Any children of these marriages remain in the succession provided that they are in communion with the Church of England. In 2008 it was announced that Peter Phillips would marry his partner, Autumn Kelly. It emerged that she had been baptised as a Catholic. Ms Kelly was accepted into the Church of England before the marriage took place and Peter Phillips retains his place in the line of succession. 12 2 The Royal Marriages Act 1772 This Act requires the descendants of George II (other than the children of princesses married into ‘foreign families’) to seek consent of the monarch before marrying. 13 The Act applies also to marriages celebrated abroad and makes such marriages without consent void. 14 Under the His Majesty’s Declaration of Abdication Act 1936 the 1772 Act was disapplied for any heirs of the Duke of Windsor. A descendant aged over 25 who persists in his/her wish to marry without consent, may do so unless both Houses of Parliament expressly disapprove of the marriage. There is no reference to the religion of the intended spouse. There have been suggestions that the Royal Marriages Act 1772 contravenes human rights legislation in requiring virtually all descendants of George II permission from the crown for their marriages, although controversy remains about its full extent. Robert Blackburn has explained the idea of constitutional control over who becomes the spouse of the reigning of future monarch as follows: The logic behind this idea is that the personality and personal life of the individual who is or may become head of state is a matter of profound public interest to the well-being of the government and the country. The head of state’s consort is inter-woven into this public interest in good governance, for he or she not only has considerable de facto official, ceremonial and diplomatic functions to perform, but normally will be the father or mother of the subsequent heir apparent. A comparative glance at monarchies elsewhere in the world indicates that similar notions often operate there too. Both Spain and Sweden, for example, have constitutional provisions debarring from the throne those who proceed with a royal marriage which is not approved by the government. 15 3 Attempts to change the law The arguments in favour of changing The Royal Marriages Act 1772 have been set out in an article by Dr Stephen Cretney, an emeritus fellow of All Souls College, Oxford, who quotes a 1955 civil service brief prepared for the Prime Minister in relation to a Parliamentary Question: 1. “It is inherently unsatisfactory that personal and constitutional questions of such high importance should still depend on the operation of an 18th Century Statute which was admittedly passed hurriedly, and in the face of considerable opposition, to deal with an ad hoc situation created largely by the unsatisfactory conduct of King George III’s brothers.” 12 13 14 15 “Fiancée secures royal succession by abandoning her Catholic Faith’, The Times, 1 May 2008 “The Royal Marriages Act 1772” Modern Law Review Vol 14 Jan 1951 suggests that descendants of Queen Elizabeth II do not come within the Act, as she was a princess marrying into a foreign family Sussex Peerage Case (1844) 11Cl and Fin 85 Blackburn, King and Country: Monarchy and the Future King Charles III, 2006, p171 6 2. The legal interpretation of the Act is uncertain; but it seems that “its ambit is now far too wide. It extends, or may extend to classes of persons whose connection with the Throne is very remote. Some think it should at least be confided to The Sovereign’s children and grand-children and the Heir Presumptive.” 3. “Although many approve in principle of control of marriages which are likely to affect the succession to the Throne, it can reasonably be argued that the sanctions against marriage without consent imposed by the Act of 1772 are too strong. A marriage without consent if void and the offspring of the union bastardised…” 4. “The provision of the Act which requires an applicant over the age of 25 who has been refused consent to give notice to the Privy Council and then wait a year, during which either House of Parliament may prevent the marriage by passing a resolution is contrary to modern ideas of propriety and fair-dealing”. 16 The Legitimacy Act 1959 introduced the doctrine of the putative marriage into English law. As a result of that Act the child of a marriage void under the Royal Marriages Act 1772 will usually be treated as the legitimate child of the parents. Dr Cretney writes: Materials now in the public domain demonstrate that there were two main options for reform of the Royal Marriages Act. [Footnote: In 1955 (when it had been thought that Princess Margaret might renounce her rights of succession on marrying Group Captain Peter Townsend) draft documents were prepared…] The first was to amend the Act by confining its application to a comparatively narrow class (for example, the current Monarch’s descendants). The second was to repeal the 1772 Act, and substitute an Act retaining the need for the Sovereign’s consent to the marriage and those close to the throne, but restriction the sanction for failure to obtain that consent to disqualification from the line of succession and from any financial provision from the Civil List. Bills were drafted by counsel to give effect to these alternatives. But by 1964 all enthusiasm for reform seems to have evaporated. Approval of those Commonwealth countries which were monarchies seems to have been an especially weighty factor, and on July 13 1964 Home Secretary Henry Brooke decided “not to proceed with legislation… at the moment”. Forty years later, there has still been no Government action to introduce the legislation…” 17 Lord Dubs introduced the Succession to the Crown [HL] Bill in the 2004-5 Session. Clause 2 of Lord Dubs’s Bill attempted to allow spouses of the King/Queen to be a Catholic, but did not attempt to repeal the Act of Settlement itself. Nevertheless, the Bill faced opposition on its second reading from the Bishop of Winchester: …if the Bill became law and made in time for a Roman Catholic consort, in a generation we could therefore have a Roman Catholic heir to the throne who could not join in communion with the Church of England. Although I pray earnestly for that reconciliation of the Roman Catholic and Anglican Churches which for me is the only proper solution to the admitted embarrassments and misunderstandings which the Bill seeks to resolve, I doubt very much whether it is wise for your Lordships' House or the 16 17 Dr S Cretney QC, ‘Royal Marriages: Some Legal and Constitutional Issues’, Law Quarterly Review, April 2008, pp235-237 Dr S Cretney QC, ‘Royal Marriages: Some Legal and Constitutional Issues’, Law Quarterly Review, April 2008, pp238-239 7 other place either to bank on the timing of that reconciliation or to seek to bring pressure to bear on its achievement. 18 Also in the 2004-05 Session Ann Taylor introduced the Succession to the Crown (no 2) Bill in the Commons, but the bill did not make progress. 19 Edward Leigh presented his ten minute rule bill Royal Marriages (Freedom of Religion) Bill on Tuesday 8 March 2005. He argued that amending the law in relation to the spouse of a monarch was a much less complex process than removing the anti-Catholic nature of the Act of Settlement. The then Lord Chancellor, Lord Falconer responded to Lord Dubs’s Bill. He stated that although the Act of Settlement and other associated Acts that exclude Roman Catholics from the succession could be seen as ‘discriminatory’, he remained opposed to what would be a complex and controversial procedure to change them: To bring about changes to the law would be a complex and controversial undertaking, raising major constitutional issues which would involve the amendment or repeal of a number of pieces of related legislation. Legislation that would need to be reviewed includes the Bill of Rights 1688, the Coronation Oath Act 1688, the Union with Scotland Act 1707, the Princess Sophia's Precedence Act 1711—I hope no one will intervene on that one—the Royal Marriages Act 1772, the Union with Ireland Act 1800, the Accession Declaration Act 1910, and the Regency Act 1937. I recognise that my noble friend's Bill deals with obvious aspects of the Union with Scotland Act and, indeed, the parallel Union with England Act of the pre-Union Scottish Parliament, but it has not addressed any of the issues raised by the other Acts to which I have referred. I should make it clear that this Government stand firmly against discrimination in all its forms, including discrimination against Catholics, and will continue to do so. The Government would never support discrimination against Catholics, or indeed any others, on the grounds of religion. The terms of the Act are discriminatory, but we should be clear that for all practical purposes, its effects are limited… There is a difference between applying new legislation such as the Human Rights Act to existing legislation, and altering legislation which is part of the backbone of our constitutional arrangements. Indeed, this legislation is interwoven within the very fabric of the constitution and has evolved over centuries. It is not a simple matter that can be tinkered with lightly. While we would wish to remove all forms of discrimination, for a variety of reasons that have been well understood in the course of this debate, this is not the appropriate form. 20 He said: There is an argument for amending the Act to remove the need for all descendants of George II having to obtain the Queen's consent before marrying. The longer the current provisions remain on the statute book, the more couples there will be who are covered by the requirements of the Act. Noble Lords should draw their own conclusions from the procedural description that I have just given. However, given the Government's current legislative programme, the issue cannot be seen as urgent and would, again, have to be part of any larger examination of constitutional issues, such as the Act of Settlement. 18 19 20 HL Deb 14 January 2005 c501 Bill 36 of 2004-5 HL Deb 14 January 2005, cc510-511 8 The Government have not said that the laws we have considered today should never be changed. They do not rule out change in the future, but we have no immediate plans to legislate in this area. As has been pointed out in the past, it is a complex undertaking and we must be careful not to embark on it before proper consultation with all parties involved. 21 Lord Falconer pointed out that there are 22 people in the line of succession to the throne after the Prince of Wales who have not been affected by the Act of Settlement’s anti-Catholic provisions, so the chances of a successor being the victim of the Act are slight. 22 It is necessary to have ‘victim status’ under the Human Rights Act 1998 to bring a case. In general, a hypothetical case would not be entertained by the courts, so would be very unlikely to progress to a hearing. Courts are not entitled to strike down primary legislation as a result of the Human Rights Act 1998. Instead courts will make a declaration of incompatibility in accordance with s4 of the Human Rights Act. This does not force Parliament to amend the law, but Parliament runs the risk of having an offending piece of legislation brought before the European Court of Human Rights if it does not replace the piece of legislation. 4 The marriage of Prince Charles to Camilla Parker Bowles The marriage of Prince Charles to Mrs Parker Bowles in 2005 raised many questions about the constitutional issues involved in royal marriages. 4.1 Princess Consort The official announcement from Clarence House noted that if Charles were to succeed to the throne, Mrs Parker Bowles would become Princess Consort: Mrs Parker Bowles will use the title HRH The Duchess of Cornwall after marriage. It is intended that Mrs Parker Bowles should use the title HRH The Princess Consort when The Prince of Wales accedes to The Throne. 23 Although Prince Philip and Prince Albert were described as consorts to the British queens they married, this appears to be the first time that the title Princess Consort has been used. In response to a PQ from Andrew Mackinlay, the DCA has indicated that the marriage is not morganatic. 24 Another parliamentary answer indicated that permission for the marriage, under the Royal Marriages Act 1772 had been granted at a Privy Council meeting on 2 March 2005. 25 In 1820 Princess Caroline of Brunswick attempted to ensure that she would be crowned alongside George IV, her estranged husband. George IV persuaded the then Prime Minister, Lord Liverpool, to introduce a bill into the House of Lords to deprive her of her rank and dissolve the marriage. The Bill was withdrawn after it only received a narrow majority at 21 22 23 24 25 HL Deb 14 January 2005 c511 HL Deb 14 January 2005 c511 See Prince of Wales, Press Release, 10 February 2005 http://www.princeofwales.gov.uk/mediacentre/pressreleases/announcement_of_the_marriage_of_hrh_the_pri nce_of_wales_and__167.html (last viewed 22 August 2008) HC Deb 17 March 2005 c462w HC Deb 17 March 2005 c462w 9 second reading. Princess Caroline tried to enter Westminster Abbey for the coronation in July 1821, but was not successful. She died the following month. 26 David Pannick QC has noted possible legal implications if Camilla Parker-Bowles did not use the title of queen. His comments are as follows: Assuming that a valid marriage takes place, Mrs Parker Bowles may, in many years' time, have an important constitutional function to perform. The Regency Act 1937 regulates what would happen if the Sovereign were to become incapacitated. If King Charles III were to spend all of his time talking to plants, so that he is "by reason of infirmity of mind or body incapable for the time being of performing the royal functions", Prince William would become Regent. Charles could be declared to be so incapacitated by three or more of the following: his "wife", the Lord Chancellor, the Speaker of the House of Commons, the Lord Chief Justice and the Master of the Rolls…There is no Act of Parliament regulating whether Camilla must be called Queen if and when Charles becomes King. But there are possible legal implications if she does not have that title. The Treason Act 1351 states that the offence of treason is committed if a person "doth compass or imagine the death of our lord the King, or of our lady his Queen". Halsbury's Statutes helpfully adds that there is an "alternative version of the original text", substituting "wife" for "Queen"….There is a potential financial advantage for Camilla in becoming Mrs Wales. Section 6 of the Civil List Act 1952 states that in the event of the death during the present reign of the Duke of Cornwall (one of the Prince's titles) his widow shall be paid during her life an annual sum (at present set at Pounds 60,000). 27 Dr Stephen Cretney has argued that Mrs Parker Bowles’s status will be that of queen, despite the use of the title princess consort. 28 The Department for Constitutional Affairs (as it was at the time) confirmed that no amendment is planned to the Civil List Act 1952. 29 A spokesman for Clarence House said that Mrs Parker Bowles may use the title Princess Consort rather than Queen without a change in the law. He said: ‘Legislation would only be required if it was deemed necessary to confirm formally that that she should not have the title and status of queen.’ 30 It is likely that alterations to the royal succession would require consent from Commonwealth countries under the Statute of Westminster 1931. 31 However, no consent would seem necessary for a marriage which does not affect the succession. Prince Philip was not styled Prince Consort, but was granted the style and patent of a Prince of the United Kingdom by letters patent of the Queen on 22 February 1957. 32 Halsbury’s Laws notes that the common law relating to the husband of a queen is not as developed as the wife of a King, due to the rarity of a Queen regnant in British history. A Queen consort has distinct prerogatives, which are now largely of historical significance, but remains a private citizen and has no right to be crowned. 33 Following her divorce from Prince Charles, Princess Diana was no longer styled Her Royal Highness, but Diana, Princess of Wales. This indicates the extent to which the royal prerogative can be used to reach an acceptable official status, without parliamentary involvement. 26 27 28 29 30 31 32 33 Ed John Cannon and Ralph Phillips The Oxford Illustrated History of the British Monarchy, 1988, pp537-8 “Imagine it: Camilla calls a couple of judges and says, Let's oust him”, The Times, 22 February 2005, “Dr Stephen Cretney” The Times, 22 February 2005 HC Deb 17 March 2005 c461-2 “Prince and Camilla ‘do not want her to be called queen” 23 March 2005 Daily Telegraph See Library Standard Note SN/PC/683 The Act of Settlement and the Protestant Succession for further details Halsbury’s Laws Vol 12(1) para 28 Queen Caroline’s Claim to be Crowned (1821) 1 State Trials NS 949 10 The Regency Act 1953 specifically nominated the spouse of Queen Elizabeth, Prince Philip, to be Regent in the event that it was necessary and that either she has no child or grandchild, or all such persons are disqualified. 34 Similar arrangements might be expected for Prince Charles, should he succeed, but these are not necessarily automatic. 4.2 The Civil Ceremony In his book, King and Country, Robert Blackburn stated that: From a purely legal perspective, the most astonishing aspect of the royal events of spring 2005 was the decision for the Prince of Wales and Camilla Parker Bowles to get married in a civil register office in England. This flew in the face of any conventional reading of the statute book on marriage law, which expressly excludes members of the royal family from marriage by way of civil registration. It flew in the face of the standard legal textbooks and works for reference, which also clearly state that members of the royal family are excluded from marriage by way of civil registration. It flew in the face of two famous royal occasions in living memory, 1936 and 1955, when everyone accepted that members of the royal family could not marry by way of civil registration. this was, after all, an accepted legal position which had fuelled the abdication crisis and driven Edward III from the throne, and been a major factor in the painful termination of Princess Margaret’s high-profile romance with a divorcee. The proposal put forward in spring 2005 directly contradicted the official legal advice that members of the royal family could not contract a legal marriage through a civil registry service, which had been given by previous Lord Chancellors to previous Prime Ministers and monarchs. 35 Following some weeks of speculation about the applicability of the law on civil marriages to marriages contracted by the royal family, the Lord Chancellor, Lord Falconer of Thoroton, made the following written ministerial statement on 23 February 2005: The Government is satisfied that it is lawful for the Prince of Wales and Mrs Parker Bowles, like anyone else, to marry by a civil ceremony in accordance with Part III of the Marriage Act 1949. Civil marriages were introduced in England by the Marriage Act 1836. Section 45 said that the Act: “… shall not extend to the marriage of any of the Royal Family”. But the provisions on civil marriage in the 1836 Act were repealed by the Marriage Act 1949. All remaining parts of the 1836 Act, including section 45, were repealed by the Registration Service Act 1953. No part of the 1836 Act therefore remains on the statute book. The Marriage Act 1949 re-enacted and re-stated the law on marriage in England and Wales. The Act covered both marriage by Church of England rite, and civil marriage. It did not repeat the language of section 45 of the 1836 Act. Instead, section 79(5) of the 1949 Act says that: “Nothing in this Act shall affect any law or custom relating to the marriage of members of the Royal Family.” The change of wording is important, and the significance is not undermined by the fact that the 1949 Act is described as a consolidation Act. The interpretation of any Act of 34 35 See Halsbury’s Laws Vol 12(1) para 13 Robert Blackburn, King and Country: Monarchy and the Future King Charles III, 2006, p54 11 Parliament, even when it consolidates previous legislation, must be based on the words used in the Act itself, not different words used in the previous legislation. In our view, section 79(5) of the 1949 Act preserves ancient procedures applying to Royal marriages, for example the availability of customary forms of marriage and registration. It also preserves the effect of the Royal Marriages Act 1772, which requires the Sovereign’s consent for certain marriages. But it does not have the effect of excluding Royal marriages from the scope of Part III, which provides for civil ceremonies. As the heading to section 79 indicates (“Repeals and savings”) it is a saving, not an exclusion. We are aware that different views have been taken in the past; but we consider that these were over-cautious, and we are clear that the interpretation I have set out in this statement is correct. We also note that the Human Rights Act has since 2000 required legislation to be interpreted wherever possible in a way that is compatible with the right to marry (article 12) and with the right to enjoy that right without discrimination (article 14). This, in our view, puts the modern meaning of the 1949 Act beyond doubt. 36 A Clarence House spokesperson was quoted in newspapers at the time as stating that: “Legal advice was taken from four different sources and all agreed that it is legal for a member of the Royal Family to marry in a civil ceremony in England”. 37 A number of commentators had drawn attention to opinions suggesting that the Marriage Act 1949 did not apply to any royal marriage. Dr Stephen Cretney suggested that the Marriage Act 1836 could render the Royal union ‘illegal’. In his view, the legislation which created civil marriages in English law did not permit members of the Royal Family to contract a civil wedding under the procedures originally created in 1836. While the act was amended by parliament in 1949, that statute makes no mention of the Royals. 38 However, in Dr Cretney’s view it would be impossible to argue that the wedding was invalid: the decision whether to allow the ceremony to go ahead was entrusted by law to the Registrar-General and he decided to grant a licence. A 1956 Aide Memoire addressed to the Lord Chancellor noted that: Marriages of members of the Royal Family are not in the same position as marriages of other persons. The statutory facilities for civil marriages are not available in England, but are available in Scotland. In England such marriages are governed by the Common Law. 39 Similarly a Home Office memo in July 1964 stated: … marriages of members of the Royal Family are still not in the same position as marriages of other persons. Such marriages have always been expressly excluded from statutes about marriage in England and Wales and marriages abroad, and are therefore governed by the common law. This means that in England and Wales such a marriage can be validly celebrated only by a clergyman of the Church of England. A civil marriage before the registrar, and marriage according to the rites of any church other than the Church of England, are not possible. 40 36 37 38 39 40 HL Deb 23 February 2005 also available at http://www.dca.gov.uk/pubs/statements/royalmarriage.htm Joshua Rozenburg, “Prince’s civil marriage will be legal, say aides”, Daily Telegraph, 15 February 2005 Ibid Royal Marriages – Aide Memoire, 10 February 1956 The Royal Marriages Act 1772, 8 July 1964, para 3 12 The earlier statement followed discussions about Princess Margaret. At the time, there was speculation that she might marry Group Captain Peter Townsend, who had divorced his first wife. In the event Princess Margaret decided not to marry him: The following personal message was issued by Princess Margaret from Clarence House last night:- “I would like it to be known that I have decided not to marry Group Captain Peter Townsend. I have been aware that, subject to my renouncing my rights of succession, it might have been possible for me to contract a civil marriage. But, mindful of the Church’s teaching that Christian marriage is indissoluble, and conscious of my duty to the Commonwealth, I have resolved to put these considerations before any others. “I have reached this decision entirely alone, and in doing so have been strengthened by the unfailing support and devotion of Group Captain Townsend. I am deeply grateful for the concern of all those who have constantly prayed for my happiness.” The message, signed “Margaret,” was dated Monday, October 31. 41 Lord Falconer’s statement suggests that this interpretation was unduly restrictive. The Human Rights Act 1998 applies to all existing legislation, not just legislation passed after 1998. S3 states: So far as it is possible to do so, primary legislation and subordinate legislation must be read and given effect in a way which is compatible with the Convention rights. But section 3(2) (b) states: [this act] does not affect the validity, continuing operation or enforcement of any incompatible primary legislation However, not all commentators accepted the position outlined by Lord Falconer. David Pannick QC stated: Section 79(5) of the 1949 Act added that nothing in that legislation "shall affect any law or custom relating to the marriage of members of the Royal Family". The whole of the 1836 Act was then repealed by the Registration Service Act 1953. The problem is that there was in 1949 a custom (based on previous law) of members of the Royal Family only marrying in church. It is very doubtful that this custom has ceased to exist, and so Section 79(5) of the 1949 Act still prevents a civil ceremony. To avoid a royal flush of embarrassment, the Prince and Mrs Parker Bowles need to find an archbishop, or a 42 vicar, who is available at short notice. For Lord Falconer, the legal row over did not come as much of a surprise. His inner circle insisted last night that he had been prepared "early last week" to make a statement outlining his view that a civil ceremony was legitimate. After consulting Tony Blair and other senior Cabinet colleagues, the written statement was put out on Wednesday. The statement was a precis of Lord Falconer's advice deemed fit for public consumption rather than the advice itself. In essence, it breezily argues that the Prince can marry Mrs Parker Bowles under the 1949 Marriage Act, which updated the law on civil marriages. If there were any doubt, he added, the Human Rights Act of 2000 gave any couple, Royal or commoner, the right to a civil ceremony "without discrimination". 41 42 “Statement by Princess Margaret”, The Times, 1 November 1955 “Camilla calls a couple of justices and says, Let’s oust him”, The Times, 22 February 2005 13 Both Lord Falconer's senior officials and Downing Street told The Sunday Telegraph that they could see "no need" for a simple two-clause Bill to "clear up" the confusion, although they admitted that, constitutionally, they were in "unknown territory" and that no one could pronounce with any certainty on the likely outcome of any legal challenge to the forthcoming wedding, were one to be launched. 43 Eleven objections to the wedding were made, under s29 of the Wedding Act 1949. Objections are made to the local registrar’s office, 44 or the office at which the ceremony will be officiated. The relevant superintendent general is duty bound to carry out an investigation. Reverend Paul Williamson of St George’s Church, Hounslow announced that he had completed an official ‘caveat’. 45 He is an outspoken representative of the evangelical wing of the Church of England. The superintendent registrar cannot issue the wedding certificate or proceed with the wedding until "he has satisfied himself that there is not sufficient evidence of the alleged impediment" or the caveat is withdrawn altogether. Caveats when received are examined by the Registrar General. An objector can seek judicial review if he disagrees with the decision of the Registrar General, but review would only be granted on fairly narrow grounds. 46 Len Cook, Registrar General found that the objections should not be sustained: The Superintendent Registrars for Chippenham and Cirencester have received and referred to me 11 caveats objecting to the marriage of The Prince of Wales and Mrs Parker Bowles. The principal grounds of objection are that the law does not allow The Prince of Wales to marry in a civil ceremony because: members of the Royal Family are a special category; special rules apply to this category; and, section 79(5) of the Marriage Act 1949 states that 'Nothing in this Act shall affect any law or custom relating to the marriage of members of the Royal Family' and the provisions of the 1949 Act governing civil marriages do not therefore apply to marriages of members of the Royal Family. I have examined into this matter and I am satisfied that it ought not to obstruct the issue of a certificate because: the natural reading of section 79(5) is that it preserves, for example, the Royal Marriages Act 1772, and the custom of the Royal Family to maintain a Royal Marriage Register; but does not exclude members of the Royal Family from Part III of the 1949 Act (as amended, in particular by the Marriage Act 1994); a reading of the 1949 Act which prevented The Prince of Wales and Mrs Parker Bowles from contracting a civil marriage would interfere with their rights under the European Convention on Human Rights ('the Convention'); and, section 3 of the Human Rights Act 1998, which requires legislation to be interpreted and given effect to in a way which is compliant with Convention rights, is a strong 43 44 45 46 “So whose head will roll?” Daily Telegraph, 27 February 2005 For Camilla Parker-Bowles, this is Chippenham “Charles: the British have no pity”, Observer, 27 February 2005 “Royal challenge”, The Times, 5 March 2005 14 obligation which supports the conclusion that The Prince of Wales and Mrs Parker Bowles can rely on the provisions of Part III of the 1949 Act. A number of other points have also been mentioned in the caveats and I have investigated whether any of these amount to a legal impediment to marriage under the Marriage Act 1949. I am satisfied that none of these objections should obstruct the issue of a certificate. 47 The Shadow Attorney General, Dominic Grieve, said that the Opposition would support any legislation which might be necessary to clarify the status of the civil wedding. 48 The former Attorney General, Sir Nicholas Lyell called for such legislation and David Pannick stated that a legal challenge would be necessary to test the argument on the implications of human rights act legislation. 49 The date of the wedding was changed from 8 April 2005 to 9 April 2005 following the death of Pope John Paul II, to enable Prince Charles to attend the Pope’s funeral in Rome on 8 April. 50 47 48 49 50 “Statement from Len Cook, Registrar General for England and Wales” 8 March 2005 “Tories back Bill to dispel legal doubts over royal wedding” 25 February 2005 Times “Charles relies on rights law he despised to validate marriage” 24 February 2005 Times “HRH Prince Charles to attend funeral of Pope John Paul II” 4 April 2005 Prince of Wales website at http://www.princeofwales.gov.uk/news/2005/04.apr/pope_funeral.php 15

OPPT: World Monetary System Foreclosure Revealed Added by GM on February 28, 2013. Saved under Business, GPS, Headlines, Insiders, Politics, Sam Davis Tags: top A Social Network for Authors New Yorker Times U.S,Capitol Building Here is part 3 of my series from guest author Andy Whiteley, about the OPPT and what it means for all of us. How Did The Trustees Achieve Foreclosure? The OPPT is managed by Trustees Caleb Skinner, Hollis Randall Hillner and Heather Ann Tucci-Jarraf. The OPPT was created when the Trustees bonded themselves to – and as a result resumed – the trust that was framed in the original US Constitution of 1776; the constitution that was abandoned when the United States government was corporatized in 1933. The OPPT then bonded every individual on the planet to this Trust as the Beneficiaries in equity, known as “the One People, created by The Creator”. By doing so, the Trustees framed a Trust that has a superior claim to any other – the Trust between the Creator and the “states of being” of Earth. The “states of being” of Earth are the beneficiaries of the Creator as the custodians of the Creator’s manifestations on Earth. Lawfully speaking, there can be no higher claim than that of the One People’s Public Trust… except for one made by the Creator. Our planet’s resources – specified in the UCC filings to be the world’s gold and silver – cannot therefore be owned, sold to us for a price, metered out in ‘salary’ quantities to enslave us, or withheld to create poverty or destitution. Under the One People’s Public Trust, we all have equity. Our planet’s resources now belong to each of us in equal measure. That is our birth right. Now it is law. Between 2011 and 2012, the Trustees lodged a complex series of filings with the UCC on behalf of its Beneficiary. Full details of the OPPT’s filings with the UCC can be found on their website: http://peoplestrust1776.org. Be warned: it is very heavy legal reading and designed for the purposes of legal noticing and disclosure, not for communicating OPPT’s actions or their implications to the general public. However the Trustees are working directly with the global ‘alternative media’ community to ensure the public receive accurate, clear and relevant information. To summarize these documents: Understanding that corporations, governments and banks are one and the same, an “Order of Finding and Action” was filed against the “the debtor”, a legal entity created via the UCC process which encompasses all corporate entities. The filings claim that the Debtor “knowingly, willingly and intentionally committed treason” by “owning, operating, aiding and abetting private money systems” and “operating Slavery Systems used against… citizens without their knowing, willing and intentional consent”. UCC filings are public records, and follow standard administrative processes. When facing a claim, an entity (in this case “the Debtor”) is given the right of rebuttal. If a rebuttal is not received within the required timeframe, a default action then applies, followed by termination of that entity; in this case, on the grounds that it failed to rebut charges of treason by “the One People”. The important thing to understand here is that a UCC filing stands as law if it remains unrebutted. And in this case, the OPPT Trustees ensured they created a legal situation in which the individuals and entities that form “the debtor” had no ability to rebut. How could they? The claims of slavery and fraud are true. Of course, no rebuttal was received. The ‘Debtor’ is therefore guilty of treason. As remedy, corporations are foreclosed and their assets re-claimed. The wealth of our planet is returned to “the One People”. All corporate debt is erased. “The system” is terminated. The public record shows it. The UCC filing stands as international law. By the system’s own terms, it no longer exists. So What Does All This Mean? Lawfully, nobody can stand as a superior authority between you and your relationship with the Creator. Having removed the control-mechanisms of economy and government, the One People’s Public Trust leaves individuals in full liability, being personally responsible for themselves and for ensuring the free-will rights of others. There is no longer a structural chain of command. No rules. No corporations to hide behind. You are – as the Creator intended – a Being and a guardian of our planet and its inhabitants. It’s a MASSIVE paradigm shift, and one that will no doubt take some time to be realized in full. The systemic barriers that inhibited our free will and choices have now been removed, which poses challenges to the way we view ourselves and the way we make choices in our own lives. We now live – on paper at least – in a system of self-responsibility. The OPPT filings register this in perpetuity, and in such a way that your free will can never be taken away without your knowing consent. Until now, our existence under the former slavery system has been a constant struggle; a struggle to balance work and family commitments; a struggle just to “make ends meet”, to “afford” a place to live – a place in which to exist. But in a world of ABUNDANCE designed specifically by the Creator to provide for our needs, this struggle was not a natural state of being. Rather it was the result of psychological warfare played out against us. And it worked! It kept us humans under control, kept us working like good little slaves, and ensured the profits kept rolling in for the privileged few in “power”. But today, by its own terms, “the system” no longer exists. Many of us saw “the system” for what it was. Many did not. Many didn’t believe that “the system” was even a system. Many will realize it shortly. Regardless, as the demise of the old paradigm takes root and becomes apparent in our societies, a psychological change must happen within all of us. It may seem overwhelming, but we humans have dealt with paradigm change before; consider the internal and psychological change required of the African American slave race when the system of involuntary servitude was abolished… of the German people when the Berlin Wall was ordered down in 1989… of the citizens of the former Soviet Union at its dissolution in 1991… of the Egyptian people who removed their dictator in 2011… and of the Icelandic people who imprisoned their corrupt bankers and politicians and re-wrote their constitution in 2012…. This type of psychological revolution is not new. But it does pose many personal challenges. This is a time to be brave, and to be bravely YOU. In the absence of a controlling structure we must each take control of our destinies, and of the destiny of our planet. We must learn to make choices for ourselves again, and start to create the world WE want to live in. Just like new parents, we must accept that life will not be the same as it was… and in the absence of a “rule book” we will attune to our instincts and learn to co-operate in new ways….. together. Why Can’t I See The Change?? Be patient… you will. But first, we need to identify how the actions of OPPT change the lawful landscape, and how that relates to us. Will the old corporate system go down fighting? Of course it will! Corporate-controlled Governments are going through the motions as though nothing has changed. And if you continue to accept their system of debt slavery, I’m sure the “Powers That Were” will happily continue to accommodate you! But don’t be fooled: they know what has happened. They know they have been foreclosed. They know the game is over. It is now international law. We have the freedom to peacefully not co-operate with the old system. It is time to exercise that freedom. If it seems strange that the visible “governments” are still masquerading as such, bear in mind…. visible governments are corporate puppets, and were never really calling the shots. At this point, the former owners want us to believe it is ‘business as usual’. They have relied heavily on secrecy until now. They will keep pretending to the very end. That is just their way. OPPT Trustee Heather Ann Tucci-Jarraf provided the following statement in a recent Freedom Radio interview that summarizes her plan to address this matter: “For those wondering about OPPT’s response to the actions or inactions of those people we can visibly see, it is the wizards and the big-dogs behind the curtain that I am coming for… and they know it. In absolute love and peace, with absolute gratitude and grace… Heather.” Guest Author Andy Whiteley is the co-founder of Wake up World and is helping the OPPT trustees get the word out. There will be one more installment in this series coming tomorrow, then on to more info on the One Peoples Public Trust moving forward. For more information, follow these 2 links. http://oppt-in.com/ http://www.peoplestrust1776.org/ Sam Davis You may also like -

Top officials caught Cross dressing..a Carnalville in Rome on Pontiff's list

Of all the rumors floating around about just why Pope Benedict XVI is hanging up his camauro, one has taken on a life of its own. According to several well-placed vaticanisti—or Vatican experts—in Rome, Benedict is resigning after being handed a secret red-covered dossier that included details about a network of gay priests who work inside the Vatican, but who play in secular Rome. The priests, it seems, are allegedly being blackmailed by a network of male prostitutes who worked at a sauna in Rome’s Quarto Miglio district, a health spa in the city center, and a private residence once entrusted to a prominent archbishop. The evidence reportedly includes compromising photos and videos of the prelates—sometimes caught on film in drag, and, in some cases, caught “in the act.” Revelations about the alleged network are the basis of a 300-page report supposedly delivered to Benedict on December 17 by Cardinals Julian Herranz, Joseph Tomko, and Salvatore De Giorgi. According to the press reports, it was on that day that Benedict XVI decided once and for all to retire, after toying with the idea for months. He reportedly closed the dossier and locked it away in the pontifical apartment safe to be handed to his successor to deal with. According to reports originally printed by La Repubblica newspaper and the newsweekly Panorama (and followed up across the gamut of the Italian media), the crimes the cardinals uncovered involved breaking the commandments “Thou shalt not steal” and “Thou shalt not commit adultery,” the latter of which has been used in Vatican-speak to also refer to homosexual relations instead of the traditional reference to infidelity. The trio of cardinals who authored the report, known in the Italian press as the “007 Priests,” were commissioned by Benedict to dig into the Vatileaks scandal that rocked the Holy See last fall when the pope’s butler, Paolo Gabriele, was convicted of stealing secret papal documents and leaking them to the press. The sleuthing cardinals ran a parallel investigation to the Vatican tribunal’s criminal case against the butler, but theirs was far more covert and focused not on the mechanics of the leaks, but on who within the Roman Curia might be the brains behind them. And, according to the leaked reports, what the “007 Priests” found went far beyond the pope’s private desk. “What’s coming out is very detailed X-ray of the Roman Curia that does not spare even the closest collaborators of the Pope,” wrote respected Vatican expert Ignazio Ingrao in Panorama. “The Pope was no stranger to the intrigues, but he probably did not know that under his pontificate there was such a complex network and such intricate chains of personal interests and unmentionable relationships.” The existence of a gay-priest network outside the fortified walls of Vatican City is hardly news, and many are wondering if it is only the tip of the proverbial iceberg of sex scandals. In 2010, investigative journalist Carmello Abbate went undercover with a hidden camera to write a shocking exposé called “Good Nights Out for Gay Priests”. Abbate caught the priests on hidden camera dirty dancing at private parties and engaging in sex acts with male escorts on church property. He also caught them emerging from dark bedrooms just in time to celebrate mass. In one postcoital scene, a priest parades around semi naked, wearing only his clerical vestments. “This is not about homosexuality,” Abbate told The Daily Beast when he published the expose. “This is about private vices and public virtues. This is about serious hypocrisy in the Catholic Church.” Because so much of the secret lives of gay priests is actually not so secret thanks to Abbate’s exposé and subsequent book, Sex and the Vatican, many are wondering what else could be hidden in the alleged red-covered dossier. Vatican elite have also been loosely tied to a number of other secular scandals during Benedict’s tenure, including the ultra-tawdry affair between former Lazio governorPiero Marrazzo and several transvestite prostitutes, including one named “Brenda” who was found burned to death in 2009. At the time that Marrazzo’s relationships with the transvestites were discovered, his driver reportedly told investigators that several high-ranking priests and even cardinals were customers of Rome’s elite transsexual circuit, though no proof was ever provided and no one has ever been arrested tied to the transsexual prostitution circuit. Nor has anyone mentioned whether reference to these crimes might also be in the dossier. But Marrazzo was whisked off to the Vatican-owned Monte Cassino abbey south of Rome to do his penance, and he even wrote a letter to Vatican Secretary of State Tarciso Bertone asking for Pope Benedict XVI’s forgiveness. Whatever secrets the red binders supposedly hold will have to remain just that until the next pope is elected. But Ingrao believes its contents are so important that the dossier will be like the 118th cardinal in the conclave. “Many new skeletons from the closets of the cardinals could come out until the beginning of the conclave,” says Ingrao. “Many voters know or claim to know the secrets of their brothers, but it is already clear that the new pope who leaves the Sistine Chapel will have to be scandal-free in order to proceed with cleaning up [what] Ratzinger has left for his successor.” Source: www.thedailybeast.com

Debtors relief case by case in their corrupted commercial law..

A debtor can remove right of implied access by displaying a notice at the entrance. This was endorsed by Lord Justice Donaldson in the case of Lambert v Roberts [1981] 72 Cr App R 223 - and placing such a notice is akin to a closed door but it also prevents a bailiff entering the garden or driveway, Knox v Anderton [1983] Crim LR 115 or R. v Leroy Roberts [2003] EWCA Crim 2753 Debtors can also remove implied right of access to property by telling him to leave: Davis v Lisle [1936] 2 KB 434 similarly, McArdle v Wallace [1964] 108 Sol Jo 483 A person having been told to leave is now under a duty to withdraw from the property with all due reasonable speed and failure to do so he is not thereafter acting in the execution of his duty and becomes a trespasser with any subsequent levy made being invalid and attracts a liability under a claim for damages, Morris v Beardmore [1980] 71 Cr App 256. Bailiffs cannot force their way into a private dwelling, Grove v Eastern Gas [1952] 1 KB 77 Otherwise a door left open is an implied license for a bailiff to enter, Faulkner v Willetts [1982] Crim LR 453 likewise a person standing back to allow the bailiff to walk through but the bailiff must not abuse this license by entering by improper means or by unusual routes, Ancaster v Milling [1823] 2 D&R 714 or Rogers v Spence [1846] M&W 571 Ringing a doorbell is not causing a disturbance, Grant v Moser [1843] 5 M&G 123 or R. v Bright 4 C&P 387 nor is refusing to leave a property causes a disturbance, Green v Bartram [1830] 4 C&P 308 or Jordan v Gibbon [1863] 8 LT 391 Permission for a bailiff to enter may be refused provided the words used are not capable of being mistaken for swear words, Bailey v Wilson [1968] Crim LR 618. If the entry is peaceful but without permission then a request to leave should always be made first. Tullay v Reed [1823] 1 C&P 6 or an employee or other person can also request the bailiff to leave, Hall v Davis [1825] 2 C&P 33 Excessive force must be avoided, Gregory v Hall [1799] 8 TR 299 or Oakes v Wood [1837] 2 M&W 791 A debtor can use an equal amount of force to resist a bailiff from gaining entry, Weaver v Bush [1795] 8TR, Simpson v Morris [1813] 4 Taunt 821, Polkinhorne v Wright [1845] 8QB 197. Another occupier of the premises or an employee may also take these steps: Hall v Davis [1825] 2 C&P 33. Also wrongful would be an attempt at forcible entry despite resistance, Ingle v Bell [1836] 1 M&W 516 Bailiffs cannot apply force to a door to gain entry, and if he does so he is not in the execution of his duty, Broughton v Wilkerson [1880] 44 JP 781 A Bailiff may not encourage a third party to allow the bailiff access to a property (ie workmen inside a house), access by this means renders the entry unlawful, Nash v Lucas [1867] 2 QB 590 The debtor's home and all buildings within the boundary of the premises are protected against forced entry, Munroe & Munroe v Woodspring District Council [1979] Weston-Super-Mare County Court Contrast: A bailiff may climb over a wall or a fence or walk across a garden or yard provided that no damage occurs, Long v Clarke & another [1894] 1 QB 119 It is not contempt to assault a bailiff trying to climb over a locked gate after being refused entry, Lewis v Owen [1893] The Times November 6 p.36b (QBD) If a bailiff enters by force he is there unlawfully and you can treat him as a trespasser. Curlewis v Laurie [1848] or Vaughan v McKenzie [1969] 1 QB 557 A debtor cannot be sued if a person enters a property uninvited and injures himself because he had no legal right to enter, Great Central Railway Co v Bates [1921] 3 KB 578 If a bailiff jams his boot into a debtors door to stop him closing, any levy that is subsequently made is not valid: Rai & Rai v Birmingham City Council [1993] or Vaughan v McKenzie [1969] 1 QB 557 or Broughton v Wilkerson [1880] 44 JP 781 If a bailiff refuses to leave the property after being requested to do so or starts trying to force entry then he is causing a disturbance, Howell v Jackson [1834] 6 C&P 723 - but it is unreasonable for a police officer to arrest the bailiff unless he makes a threat, Bibby v Constable of Essex [2000] Court of Appeal April 2000. Vaughan v McKenzie [1969] 1 QB 557 if the debtor strikes the bailiff over the head with a full milk bottle after making a forced entry, the debtor is not guilty of assault because the bailiff was there illegally, likewise R. v Tucker at Hove Trial Centre Crown Court, December 2012 if the debtor gives the bailiff a good slap. If a person strikes a trespasser who has refused to leave is not guilty of an offence: Davis v Lisle [1936] 2 KB 434 License to enter must be refused BEFORE the process of levy starts, Kay v Hibbert [1977] Crim LR 226 or Matthews v Dwan [1949] NZLR 1037 A bailiff rendered a trespasser is liable for penalties in tort and the entry may be in breach of Article 8 of the European Convention on Human Rights if entry is not made in accordance with the law, Jokinen v Finland [2009] 37233/07

Pope Benedict resigned to avoid arrest, seizure of church wealth by Easter

Historic, Breaking News: Wednesday, February 12/13, 2013 - Diplomatic Note was issued to Vatican just prior to his resignation New Pope and Catholic clergy face indictment and arrest as "Easter Reclamation" plan continues A Global Media Release and Statement from The International Tribunal into Crimes of Church and State (ITCCS) Brussels: The historically unprecedented resignation of Joseph Ratzinger as Pope this week was compelled by an upcoming action by a European government to issue an arrest warrant against Ratzinger and a public lien against Vatican property and assets by Easter. The ITCCS Central Office in Brussels is compelled by Pope Benedict's sudden abdication to disclose the following details: 1. On Friday, February 1, 2013, on the basis of evidence supplied by our affiliated Common Law Court of Justice (itccs.org), our Office concluded an agreement with representatives of a European nation and its courts to secure an arrest warrant against Joseph Ratzinger, aka Pope Benedict, for crimes against humanity and ordering a criminal conspiracy. 2. This arrest warrant was to be delivered to the office of the "Holy See" in Rome on Friday, February 15, 2013. It allowed the nation in question to detain Ratzinger as a suspect in a crime if he entered its sovereign territory. 3. A diplomatic note was issued by the said nation's government to the Vatican's Secretary of State, Cardinal Tarcisio Bertone, on Monday, February 4, 2013, informing Bertone of the impending arrest warrant and inviting his office to comply. No reply to this note was received from Cardinal Bertone or his office; but six days later, Pope Benedict resigned. 4. The agreement between our Tribunal and the said nation included a second provision to issue a commercial lien through that nation's courts against the property and wealth of the Roman Catholic church commencing on Easter Sunday, March 31, 2013. This lien was to be accompanied by a public and global "Easter Reclamation Campaign" whereby Catholic church property was to be occupied and claimed by citizens as public assets forfeited under international law and the Rome Statute of the International Criminal Court. 5. It is the decision of our Tribunal and the said nation's government to proceed with the arrest of Joseph Ratzinger upon his vacating the office of the Roman Pontiff on a charge of crimes against humanity and criminal conspiracy. 6. It is our further decision to proceed as well with the indictment and arrest of Joseph Ratzinger's successor as Pope on the same charges; and to enforce the commercial lien and "Easter Reclamation Campaign" against the Roman Catholic church, as planned. In closing, our Tribunal acknowledges that Pope Benedict's complicity in criminal activities of the Vatican Bank (IOR) was compelling his eventual dismissal by the highest officials of the Vatican. But according to our sources, Secretary of State Tarcisio Bertone forced Joseph Ratzinger's resignation immediately, and in direct response to the diplomatic note concerning the arrest warrant that was issued to him by the said nation's government on February 4, 2013. We call upon all citizens and governments to assist our efforts to legally and directly disestablish the Vatican, Inc. and arrest its chief officers and clergy who are complicit in crimes against humanity and the ongoing criminal conspiracy to aid and protect child torture and trafficking. Further bulletins on the events of the Easter Reclamation Campaign will be issued by our Office this week. Issued 13 February, 2013 12:00 am GMT by the Brussels Central Office, The International Tribunal into Crimes of Church and State http://www.itccs.org/ =================================== Pope Leaves Financial Disarray in His Wake http://www.thefiscaltimes.com/Articles/2013/02/11/Pope-Benedict-Leaves-Financial-Disarray-in-His-Wake.aspx#page1

Pope resigns!!!

A sign from above? Lightning strikes Vatican hours after Pope's shock resignation http://www.mirror.co.uk/news/world-news/lightning-strikes-vatican-on-the-day-the-pope-1704295 A sign from above? Lightning strikes Vatican hours after Pope's shock resignation 11 Feb 2013 21:47 The lightning touched the roof of St. Peter's Basilica, one of the holiest Catholic churches, hours after Benedict XVI's shock announcement This was the moment lightning struck the Vatican today - hours after Pope Benedict XVI's bolt-from-the-blue resignation. The lightning touched the dome of St. Peter's Basilica, one of the holiest Catholic churches, after the Pope's shock admission he lacks strength to do the job. The Vatican stressed that no specific medical condition prompted Benedict's decision to quit - the first pontiff to do so in 600 years. The move surprised even his closest aides, even though Benedict, 85, had made clear in the past he would step down if he became too old or infirm. In recent years, the Pope has slowed down significantly, cutting back his foreign travel and limiting his audiences. He now goes to and from the altar in St Peter's Basilica on a moving platform, to spare him the long walk down the aisle. Occasionally he uses a cane. His 89-year-old brother, Georg Ratzinger, said doctors had recently advised the Pope not to take any more trans-Atlantic trips. "His age is weighing on him," Mr Ratzinger said. "At this age my brother wants more rest." Benedict announced his resignation in Latin during a meeting of Vatican cardinals, calling it "a decision of great importance for the life of the church." He emphasised that carrying out the duties of being pope requires "both strength of mind and body." He told the cardinals: "I have come to the certainty that my strengths due to an advanced age are no longer suited to an adequate exercise of the Petrine ministry." The Vatican will hold a conclave before Easter to elect a new pope, with Benedict holding great sway over who should succeed him to lead the world's one billion Catholics. Benedict has already hand-picked the bulk of the College of Cardinals - the princes of the church who will elect the next pope - to guarantee an equally-conservative legacy. There are no obvious front-runners to replace him - the same situation when Benedict was elected in 2005 after the death of Pope John Paul II. Given half of the world's Catholics live in the global south, there will once again be arguments for a pope to come from the developing world. When Benedict was elected aged 78, he was the oldest pope chosen in nearly 300 years. He raised the possibility of resigning if he were too old or sick to continue, when he was interviewed in 2010 for the book "Light of the World." "If a pope clearly realises that he is no longer physically, psychologically and spiritually capable of handling the duties of his office, then he has a right, and under some circumstances, also an obligation to resign," Benedict said. The former Cardinal Joseph Ratzinger had an intimate view as Pope John Paul II, with whom he had worked closely for nearly a quarter-century, suffered through the debilitating end of his papacy. The Vatican said immediately after his resignation that Benedict would go to Castel Gandolfo, a summer retreat south of Rome, and then would live in a cloistered monastery. Benedict said he would serve the church for the remainder of his days "through a life dedicated to prayer." Obi-Wan Kabuki at 11:03 PM

More Scamming commercial gurus get busted!!

Indictments Rage on for 1099 OID Scammers I thought I would write and explain... Why YOU should shy away from Patriot Myth Mongers (PMM): You Could Go To JAIL. Maybe you can see a bigger issue in this: People generally go to jail for doing something wrong that endangers or hurts government or fellow humans. Here's a case in point: The FAKE 1099 OID Tax Return. What they did wrong: Filed the fake 1099 OID tax return to get undeserved money from the IRS/Treasury. Intended Purpose: The 1099 OID serves only one legitimate purpose. People who buy original issue bonds at a discount and agree to forego coupon interest can sell the bonds back at face value, generally at maturity, or if the corporation calls in the bonds early. The 1099 OID return identifies to the IRS the amount of money earned at maturity, the difference between the discount price and the face amount. The scheme: scammers get conned into believing that US Government went bankrupt in 1933 (even though no such court case exists) and converted all Americans into chattel of the creditors from birth. Thus government ultimately guarantees payment of all debts from a secret birth certificate bond account with the Treasury. By filing the 1099 OID with some related forms, the scammers get the government pay their tax debt, plus some. The Problem: The scheme actually cheats government out of tax revenues. Maybe many other reasons can explain why people don't actually owe the taxes, but the 1099OID scam presumes they do, and then makes a false claim to government, a felony crime. I know of two central PMMs who promoted this nonsense: Winston Shrout and Sam Kennedy. I heard of numerous accolytes who learned from those gurus and then became gurus themselves, like Sam Davis, Tim Turner (who filed fake maritime liens against people he didn't like), Paul Laird, etc. And many others learned from them to become "practitioners" who would fill in paperwork for people who then filed them and got busted. My Beef: I do not love the IRS. I consider the IRS a criminal enterprise for its abusive collection of taxes I believe people do not owe. As a student of history, I acknowledge effective legal and political activism (including everything from elections, pressuring elected representatives, picketing, marching demonstrations, and open rebellion) for defeating crookedness in government, such as IRS crimes. However, I discourage individual crimes like FILING FALSE tax returns because they become a nifty way to win a prison term. AND you will still owe the money plus penalties. Many victims of such hoaxes became criminals. And only a doofus could possibly claim "I didn't think I was doing anything wrong." What Ultimately Happens: Grand Juries Indict Scammers, the DOJ Prosecutes them, Courts Convict Them, THEY GO TO PRISON As I have explained in the past, Winston Shrout, Glenn Richard Unger (Sam Kennedy), Sam Davis, Tim Turner, and others conducted seminars over the past 7 years instructing attendees on the "correct" methods to use in filing fraudulent financial instruments like 1099 OID in connection with income tax returns and other interactions with Government. Until a couple of weeks ago, the main theorists avoided prosecution. But the IRS and DOJ investigations have landed indictments against their Patriot Myth Mongering (PMM) understudies like Sam Davis and James Timothy "Tim" Turner. Chris Marrero got indicted in 2011. Pete Hesser from Port Charlotte just got convicted in November for filing false returns and tax evasion for that. And Glenn Unger ("Sam Kennedy") just got indicted a few days ago. Follow these links and read for yourself: Examples: David Marrero http://www.forbes.com/sites/billsinger/2012/05/03/federal-inmate-indicted-for-filing-false-tax-returns-from-prison/ Sam Kennedy (Glenn Unger) http://www.justice.gov/usao/nyn/news/1795-3530-669737344.pdf Chris Marrero http://www.justice.gov/tax/txdv111583.htm Straw Man Fraud http://blogs.browardpalmbeach.com/pulp/2011/12/straw_man_tax_fraud_south_florida.php Pete Hesser http://www.justice.gov/usao/flm/press/2012/dec/20121205_Hesser.html Sam Davis http://www.justice.gov/usao/nv/press/march2011/davismarch252011.htm James Timothy Turner http://www.justice.gov/opa/pr/2012/September/12-tax-1126.html EFFECTIVE ACTIVISM If you agree with my assessment of the IRS, don't fight the battle against them alone because you will lose. The US Congress has devised a perfect way of making you into a slave in violation of the principles of the US Constitution. They wrote a confusing law (codified in 26 USC) which most Americans find daunting, arcane, and inscrutable. Most of America's Legal community, including the DOJ, have construed the Constitution ( especially the 16th Amendment) as supporting the direct taxation of the people in spite of crystal clear language that Congress shall apportion direct taxes among (and collect them from) the states (state legislatures). The President and the IRS agree with the lawyers. Generally, so do the courts. I don't. And I have only one voice. So I have hundreds of thousands of government operatives against me. I have two points to make: I cannot and shall not go it alone in a battle against the IRS and DOJ and Courts and Congress and President on the issue of income and wage taxes. Millions of informed, armed, resolute, belligerent Americans can defeat the abusive scheme of income and wage taxation by legal and political action ONLY if they work together and focus their power on the weakest part of government - the individual operative, removing the evil perps one at a time till none remain. The ICE PICK Government beats individual Americans on the tax issue by the ICE PICK method. The full power of the government focuses on one tiny needle-sharp point of cold steel: the bank accounts. Government agents forcibly extract so-called tax money from the accounts of recalcitrant taxpayers in banks, and banks cooperate. Failing that, the operatives steal automobiles, houses, and wages through unjust liens and levies. Failing that, theyget an indictment, prosecute, convict, and imprison the recalcitrant taxpayer. One Obama Democrat, taking his cue from 9-11-2001, protested abusive taxes by crashing his airplane into the IRS building in Austin, Texas. Had he managed to fly a freshly fueled Boeing 787 into the White House US Capitol building in Washington DC, that might have gotten his point across. If that continued to happen in a variety of ways, maybe Congress would get the point. But short of massive, meaningful protest that "No means No," the tax abuse will continue. Bottom line, you cannot break down a block of ice by smacking it with the flat of your hand. You use an ice pick. You focus all the power of your arm on the point, and when you jam it into the block of ice, with that force, it begins to shatter and break apart. I believe the voter base has become watered down by immigration and procreation of millions of people of such low intelligence that when they vote, the always vote for candidates who will make laws that rob from one group of people to give to another. And I believe that the super-smart of the world have used credit and debt to enslave the people, corrupt the government, and destroy the value of savings and of our currency. And I believe that the energy producers, including oil companies, have joined in to keep the world enslaved to fossil fuels and nuclear power when we should have switched to water fracturing technology to produce HHO gas decades ago for our power sources. America needs crash programs to produce HHO gas through water fracturing devices, and to establish eugenics programs to clean up the gene pool, and to re-engineer suffrage so the irresponsible and ignorant cannot have any voice in government. America needs to return to family values so that men and women marry, produce children, and stay married to rear those children in a responsible household environment so the children become good and sensible citizens. This means all of us should start to work on that today, right now. We cannot stop runaway spending that justifies bilking the populace without forceful, pin-point political and legal activism. How will YOU make that happen? Bob Hurt Blog 1 2 3 f t 2460 Persian Drive #70 Clearwater, FL 33763 Email; Call: (727) 669-5511 Law Studies: Donate Subscribe Learn to Litigate with Jurisdictionary

BC Doctor's research exposes Vaccines as a fraud!!

1 The vaccination policy and the Code of Practice of the Joint Committee on Vaccination and Immunisation (JCVI): are they at odds? Lucija Tomljenovic, PhD Neural Dynamics Research Group, Dept. of Ophthalmology and Visual Sciences, University of British Columbia, 828 W. 10th Ave, Vancouver, BC, V5Z 1L8, lucijat77@gmail.com Introduction No pharmaceutical drug is devoid of risks from adverse reactions and vaccines are no exception. According to the world’s leading drug regulatory authority, the US Food and Drug Administration (FDA), vaccines represent a special category of drugs in that they are generally given to healthy individuals and often to prevent a disease to which an individual may never be exposed [1]. This, according to the FDA, places extra emphasis on vaccine safety. Universally, regulatory authorities are responsible for ensuring that new vaccines go through proper scientific evaluation before they are approved. An equal responsibility rests on the medical profession to promote vaccinations but only with those vaccines whose safety and efficacy has been demonstrated to be statistically significant. Furthermore, vaccination is a medical intervention and as such, it should be carried out with the full consent of those who are being subjected to it. This necessitates an objective disclosure of the known or foreseeable risks and benefits and, where applicable, a description of alternative courses of treatment. In cases where children and infants are involved, full consent with regards to vaccination should be given by the parents. Deliberately concealing information from the parents for the sole purpose of getting them to comply with an “official” vaccination schedule could thus be considered as a form of ethical violation or misconduct. Official documents obtained from the UK Department of Health (DH) and the Joint Committee on Vaccination and Immunisation (JCVI) reveal that the British health authorities have been engaging in such practice for the last 30 years, apparently for the sole purpose of protecting the national vaccination program. Here I present the documentation which appears to show that the JCVI made continuous efforts to withhold critical data on severe adverse reactions and contraindications to vaccinations to both parents and health practitioners in order to reach overall vaccination rates which they deemed were necessary for “herd immunity”, a concept which with regards to vaccination, and contrary to prevalent beliefs, does not rest on solid scientific evidence as will be explained. As a result of such vaccination policy promoted by the JCVI and the DH, many children have been vaccinated without their parents being disclosed the critical information about demonstrated risks of serious adverse reactions, one that the JCVI appeared to have been fully aware of. It would also appear that, by withholding this information, the JCVI/DH neglected the right of individuals to make an informed consent concerning vaccination. By doing so, the JCVI/DH may have violated not only International Guidelines for Medical Ethics (i.e., Helsinki Declaration and the International Code of Medical Ethics) [2] but also, their own Code of Practice (http://www.dh.gov.uk/prod_consum_dh/groups/ dh_digitalassets/@dh/@ab/documents/digitalasset/dh_115363.pdf). The transcripts of the JCVI meetings also show that some of the Committee members had extensive ties to pharmaceutical companies and that the JCVI frequently co-operated with vaccine manufacturers on strategies aimed at boosting vaccine uptake. Some of the meetings at which such controversial items were discussed were not intended to be publicly available, as the transcripts were only released later, through the Freedom of Information Act (FOI). These particular meetings are denoted in the transcripts as “commercial in confidence”, and reveal a clear and disturbing lack of transparency, as some of the information was removed from the text (i.e., the names of the participants) prior to transcript release under the FOI section at the JCVI website (for example, JCVI CSM/DH (Committee on the Safety of Medicines/Department of Health) Joint Committee on Adverse Reactions Minutes 1986-1992; http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306). BSEM March 2011 The Health Hazards of Disease Prevention 2 Assertions In summary, the transcripts of the JCVI/DH meetings from the period from 1983 to 2010 appear to show that: 1) Instead of reacting appropriately by re-examining existing vaccination policies when safety concerns over specific vaccines were identified by their own investigations, the JCVI either a) took no action, b) skewed or selectively removed unfavourable safety data from public reports and c) made intensive efforts to reassure both the public and the authorities in the safety of respective vaccines; 2) Significantly restricted contraindication to vaccination criteria in order to increase vaccination rates despite outstanding and unresolved safety issues; 3) On multiple occasions requested from vaccine manufacturers to make specific amendments to their data sheets, when these were in conflict with JCVI’s official advices on immunisations; 4) Persistently relied on methodologically dubious studies, while dismissing independent research, to promote vaccine policies; 5) Persistently and categorically downplayed safety concerns while over-inflating vaccine benefits; 6) Promoted and elaborated a plan for introducing new vaccines of questionable efficacy and safety into the routine paediatric schedule, on the assumption that the licenses would eventually be granted; 7) Actively discouraged research on vaccine safety issues; 8) Deliberately took advantage of parents’ trust and lack of relevant knowledge on vaccinations in order to promote a scientifically unsupported immunisation program which could put certain children at risk of severe long-term neurological damage; Notably, all of these actions appear to violate the JCVI’s own Code of Practice (http:// www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/ dh_115363.pdf). BSEM March 2011 The Health Hazards of Disease Prevention 3 Evidence I here provide the evidence in support of each of the above assertions. (Note: emphasis added throughout the text as underlined are by the author unless otherwise indicated) 1) Instead of reacting appropriately by re-examining existing vaccination policies when safety concerns over specific vaccines were identified by their own investigations, the JCVI either a) took no action, b) skewed or selectively removed unfavourable safety data from public reports and/or c) made intensive efforts to reassure both the public and the authorities in the safety of respective vaccines. As early as 1981, the JCVI had substantial documentation which associated the measles vaccine with serious adverse reactions including death and long-term adverse neurological outcomes. At the JCVI meeting held on 9th April 1981 (http://www.dh.gov.uk/ab/ DH_095169), in discussing a paper that summarised all the reports of adverse reactions to the CSM, the following was noted: (5.b.) Adverse Reactions to measles vaccine “All reports since 1970 of encephalitis, encephalopathy or sudden death shortly after vaccination had been reviewed; 60 patients were involved of whom 8 had died, 36 had made an apparent complete recovery and 16 were left with permanent sequelae. The high proportion of deaths and patients with sequelae was surprising in comparison with the findings of the NCES [National Childhood Encephalopathy Study].”(5.b. Adverse Reactions to measles vaccine) By 1983, the JCVI appeared to have had more evidence that the measles vaccine could cause encephalitis associated with “severe handicap” in a subset of vulnerable children. At the JCVI meeting on 17th of June 1983 (http://www.dh.gov.uk/ab/JCVI/DH_120115), the Committee on Safety of Medicines (CSM) received 66 reports of suspected adverse reactions to measles vaccines over the period January 1982 to April 1983. According to the transcript of the meeting: (7. Suspected adverse reactions to measles vaccine: recent reports to the CSM) “These included three cases of encephalitis; on follow-up, two of these patients were left one year later with severe handicap and the third patient, after a year, appeared to be developmentally normal.” By the end of 1981 serious safety concerns have also been raised with regards to another routine paediatric vaccine, the whooping cough vaccine. At the meeting held on 3rd November 1981 (http://www.dh.gov.uk/ab/DH_095169) in section 5 on Whooping Cough: (5.d. Comments on Professor Stewart’s letter) “Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event.” Furthermore: “The Chairman concluded that much was not known about the natural history of brain damage in the young.” In spite of this, three years later, at the meeting on 25th of April 1986 (http:// www.dh.gov.uk/ab/DH_095169), the JCVI concluded their discussion on suspected adverse BSEM March 2011 The Health Hazards of Disease Prevention 4 reactions for the period 19th September 1985 to 15th of January 1986 with the following statement: (11.4) “The Committee agreed to a suggestion from the Chairman that in future it would accept reports on adverse reactions as “for information” only.” [their emphasis added-quotation marks] It is somewhat perplexing why the JCVI adopted what appears to be a rather passive approach to vaccine safety, in light of the severe adverse reactions that were reported at that meeting. These included cot deaths, convulsions and anaphylaxis (11.4). The JCVI appeared to have had other solutions for dealing with vaccine safety concerns. In a “commercial in confidence” CSM/JCVI/Joint Sub-Committee on Adverse Reactions to Vaccination and Immunisation (ARVI) meeting on 7th February 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306), in a discussion about a surveillance study on adverse reactions to two measles vaccines, the members noted that: “...results showed that 70 per cent of children were well after receiving Attenuvax and 61 per cent after receiving Rimevax. If children with mild general reactions were added to those who were apparently well then the numbers associated with Attenuvax were 85 per cent and those with Rimevax 80 per cent.” (7.1 PHLS [Public Health Laboratory Service] surveillance of adverse reactions to two measles vaccine (Rimevax and Attenuvax)) In other words, even skewing the data by adding cases of mild reactions to those who were “apparently” well, did far from producing a reassuring statistic in favour of the safety of the measles vaccines, as it still implied a rate of 15-20% of vaccine-associated serious adverse reactions (as opposed to 30-39% of mild-to-serious adverse reactions in total). After further discussion on this topic: “...it was agreed there was now enough information to stop the study.” While at the same time, there appeared to be no incentive to reconsider the current immunisation policy, in fact, it seemed more reasonable to conclude that some of the suspected adverse reactions to measles vaccine: “...were unlikely to be associated with the use of measles vaccine and were more likely to be temper tantrums.” (7.2 Suspected adverse reactions to measles vaccine: a summary of recent reports to the CS, June 1983 to September 1985) The summary of suspected adverse reactions to DTP vaccine administered alone or with oral polio (OPV) during the period 19th September 1985 to 15th January 1986, presented at the same “confidential” meeting (CSM/JCVI/Joint Sub-Committee ARVI, 7th February 1986) were more difficult to ascribe to “temper tantrums”: (9.(1)) “Ninety such adverse reactions have been registered. These included six patients with convulsions, one a patient with abnormal fever following vaccination and one patient with apparent cerebral irritability; in addition two cot deaths were reported. (i) Case No. 154043 A three-month old boy who after his first dose of Trivax AD and OPV on 17 September 1985 was found dead 18 hours after immunisation....(ii) Case No. 154080 A three-month old girl who received her first dose of Trivax and OPV on the 19 September 1985 and was found dead on the night of 21/22 September 1985. No initial adverse reaction to vaccination was reported and the cause of death was stated as SIDS.” [sudden infant death syndrome] By mid to the late 1980s, the JCVI had become increasingly concerned about publicly associating the terms “death” and/or “brain damage” with the word “vaccine”, because of the negative BSEM March 2011 The Health Hazards of Disease Prevention 5 repercussions they perceived this would have on vaccination policy (CSM/JCVI/Joint Sub-Committee ARVI meetings on 7th February 1986; 3rd October 1986; http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306). Such concerns were also exacerbated by the increasing burden of litigations about pertussis vaccine-suspected injuries (JCVI meeting on 22nd April 1988; 20th October 1988; http:// www.dh.gov.uk/ab/DH_095169), and the possibility that vaccination could be linked to some cases of SIDS, as evident from the Reports on Yellow Cards quoted above. At the meeting on 22nd April 1988 (http://www.dh.gov.uk/ab/DH_095169), in an ongoing discussion about the Loveday v Renton litigation, the Chairman: “...reminded members that they had asked for a list of documents disclosed. JCVI (88)1 provided such a list, but it should not be made public. Dr Salisbury said that the Department’s solicitors had advised that a part of the section on whooping cough in the revised Memorandum was in conflict with the judgement in the above-mentioned case. They had recommended that any statement on the risk of neurological reaction should avoid any estimate of the size of the risk of death or permanent brain damage. Dr Salisbury said that paragraph 3.4.1c of the section on whooping cough in the Memorandum had been modified accordingly and this modification was tabled. Professor Miller observed that the conclusion to be reached from the judgment of the Court and from the assessment of the scientific evidence of risk of neurological reactions and their consequences, were not necessarily the same. The legal judgement was that there is insufficient evidence, on the balance of probabilities that the vaccine causes permanent damage to allow any claim for damages to succeed. The JCVI was concerned with the implications of scientific assessment of the evidence for vaccine policy purposes. On this basis he was content to quote the figure for attributable risk of serious neurological illness without giving a figure for the risk of permanent damage, which was consistent with the conclusion of the NCES quoted in the Whooping Cough Report 1981.”(Item 5, page 4 – Loveday v Renton) The extent of the JCVI’s concerns with the implications of scientific assessment of vaccine safety on vaccine policy explains why they were opposed to any long-term surveillance for severe neurological disorders following vaccination. In fact, as it will be shown below in greater detail, the CSM/JCVI/ARVI considered such studies “unreasonable” and paradoxically, ARVI even “deprecated the use of the term ‘brain damage’” (CSM/JCVI/Joint Sub-Committee ARVI meeting held on 7th February 1986; h t t p : / / w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t i o n / Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306). In 1989, 10 years prior to the “controversial” Lancet report by Wakefield et al. [3], the JCVI appeared to have been fully aware of the outcomes of the investigation carried out by the National Institute for Biological Standards and Control (NIBSC), which unequivocally established a link between the mumps component of the MMR vaccine (the Urabe-9 strain) and cases of vaccineinduced meningitis/encephalitis. In response to this, the JCVI appeared to have actively engaged in skewing and censoring data available to the public, continued to use the Urabe-9 containing MMR vaccines and made intensive efforts to reassure both the public and the authorities of the safety of all MMR vaccines. According to the transcript of the JCVI meeting on 3rd November 1989 (http://www.dh.gov.uk/ab/ DH_095169), the causal agent of vaccine-induced meningitis/encephalitis was unequivocally identified: (9. ARVI Committee – Minutes of meeting 6 October 1989 (JCVI (89)25) “Prof Collee expressed gratitude to the NIBSC for the progress it achieved in developing techniques to identify wild and vaccine virus strains. Dr Schild reported that NIBSC was now able to distinguish clearly the wild strains from each of the two vaccines, and isolates from CSF clearly showed Urabe in all three cases believed to be associated with vaccine-although it should not be assumed that Jeryl-Lynn is not capable of the same result. Professor Collee added that no mumps vaccine could be said to be void of risk. Dr Schild said NIBSC would be happy to continue analysing samples.” BSEM March 2011 The Health Hazards of Disease Prevention 6 In the following meeting on 17th September 1990, the JCVI CSM/DH Joint Sub-Committee on Adverse Reactions (http://www.dh.gov.uk/ab/JCVI/DH_095294), on reviewing the adverse reactions to the MMR vaccine reported on Yellow Cards, applied the following criteria to the assessments: (6.3.1.) “Definite=Virus isolated from CSF [cerebrospinal fluid], time course of 14-28 days; Possible/probable=Cells isolated from CSF, no virus in CSF, acceptable time course” [their emphasis added-underlined] The transcript then states: “It was noted that there were 10 definite cases of meningitis/encephalitis.” Both definite and probable cases were then discussed in some detail: (6.3.4.) “It was noted that the mumps viruses obtained from two out of three cases from Nottingham were sequenced and shown to be vaccine related. The patients had all been vaccinated from different batches and did not live close to each other.” At the 17th September 1990 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095294), the JCVI CSM/DH Joint Sub-Committee on Adverse Reactions did recognize the need to do a followup analyses for long-term neurological outcomes in all cases of meningitis/encephalitis associated with the MMR vaccine. It was also recognized that the current avenues for adverse reactions reporting (via the Yellow Card, the British Paediatric Surveillance Unit (BPSU) scheme, directly to Communicable Disease Surveillance Centre (CDSC) and through Laboratory reports) were inadequate for detailed epidemiological evaluations. The JCVI CSM/DH Joint Sub-Committee then stated that: (6.4) “In order to further validate vaccine related illnesses, fuller studies would be required.” Despite these unresolved safety issues, the conclusion reached at the meeting was that: (6.7) “There should be no change in the present recommendations or supply of MMR vaccine on the evidence available to us at the present time.” Thus, instead of re-evaluating the vaccination policy, at least until safety concerns were fully evaluated, the JCVI choose to support the existing policy based on incomplete evidence that was available at that time. Furthermore, at the 17th September 1990 meeting (http://www.dh.gov.uk/ab/JCVI/ DH_095294), the JCVI appeared to have been fully aware of increasing numbers of cases of mumps vaccine-associated aseptic meningitis occurring in Japan, since at the time of the meeting, they had been presented with a draft of a study by Sugiura et al. [4]. The Japanese study found that among 630,157 recipients of the MMR vaccine containing the Urabe-9 mumps vaccine, there were at least 311 meningitis cases suspected to be vaccinerelated. In 96 of these 311 cases, mumps virus related to the vaccine was isolated from the CSF. Sugiura et al. [4] noted that this was an unusually high incidence of vaccine-related adverse outcomes, which they had attributed in part to “adverse media publicity”. Nonetheless, the fact that in almost one third of the cases, the vaccine strain had been isolated from the CSF of children, suggests that safety concerns over the MMR were warranted. Indeed, in 1993 the Japanese suspended the use of the MMR vaccines containing the Urabe strain due to it causing a high incidence of aseptic meningitis, and reverted to the use of monovalent measles, mumps and rubella vaccines. According to Japanese Health Authorities, the withdrawal of the MMR had not caused an increase in deaths from wild BSEM March 2011 The Health Hazards of Disease Prevention 7 measles infection. Noteworthy, in a BBC news report (http://news.bbc.co.uk/2/hi/asiapacific/ 1808316.stm), a spokesperson for the Japan’s Health Ministry stated that: “...more children had died from the disease during the period when MMR was being used.” In reference to the Japanese study, the JCVI transcript specifically states: (6.6) “The paper confirmed information from Japan previously disclosed to ARVI.” This suggests that the JCVI knew for some time that the Urabe-9 vaccine was causing problems and yet, did not consider the possibility to temporarily suspend its use. Furthermore, four months prior to the 17th September 1990 meeting, at the JCVI 4th May 1990 meeting (http://www.dh.gov.uk/ab/DH_095169), ARVI expressed concerns regarding the reports from Japan. The major reason for these concerns was not that the JCVI/ARVI were in favour of using the Urabe-9 vaccine which was now associated with increased risk of meningitis/encephalitis in children, but rather: (9.1.) “Professor Banatvala was concerned about the possibility of the Japanese experience being published widely in the UK, and urged the gathering of information on the various episodes from all MMR manufacturers.” ARVI also reached a rather surprising conclusion that: “The Japanese experience may be due to different reporting/investigating criteria or other local factors.” However, if this were the case, “the Japanese experience” would have been an isolated event. That this was not the case can be clearly seen from further readings of the JCVI 4th May 1990 meeting transcript (http://www.dh.gov.uk/ab/DH_095169): (9.3.a.) “Dr Thores spoke to the letter, JCVI/90/10, from Dr McIntyre. He highlighted SHHD [Scottish Home and Health Department] concern about the Canadian decision not to use Urabe strain vaccine, the cases of neurological complications in Japan, the seeming bias of the UK adverse reactions towards Scotland, and the continued use of vaccine distribution figures as the denominator when calculating adverse reaction rates.” In spite of this, instead of re-evaluating or suspending the existing MMR vaccination policy due to safety concerns, the JCVI called for a specific and concentrated effort aimed at counteracting the growing public and health authorities’ concern over the safety of the Urabe-9 MMR vaccines. (9.3.c.) “Professor Peckham told the Committee that she was aware of three districts changing from use of Urabe to Jeryl Lynn vaccine, and therefore the Committee needed to reassure authorities of the safety of all MMR vaccines.” Hence, it appears that the JCVI’s solution to the growing problem regarding the MMR vaccine safety issues was to provide as little information as possible to health practitioners, in order to preserve the JCVI’s vaccination policy. If this assumption is correct, does it suggest that the JCVI was more concerned about boosting vaccine uptake than child safety? (9.3.e.) “The Chairman asked the Committee if it thought necessary to draw up a statement about MMR.” BSEM March 2011 The Health Hazards of Disease Prevention 8 (9.3.g.) “Professor Hull suggested a simple sheet with ARVI’s evaluation of the vaccines. This would let doctors know that an expert committee had looked at the situation and perhaps reassure them.” What appears to be a rather inadequate handling of the MMR safety concerns on behalf of the JCVI did not make the problem go away. Only a year later, at 1st November 1991 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), unable to resolve the continuing MMR safety issues the JCVI turned to vaccine manufacturers for help: (7.1 Report on MMR) “On adverse reactions to the vaccine, the most worrying reports had been studies which showed problems with the Urabe vaccine, particularly Mumps Meningitis. Reports had also come from overseas countries, Canada being the most helpful….of 67 reported cases between October 1988 and August 1990, 38 children had definite or probable Aseptic Meningitis and one Encephalitis. Ten of these were definitely caused by the vaccine, and a further 29 were probably caused by the vaccine. Of these 39 children, 37 were followed up at 12 months. 33 (or 89%) were neuro-developmentally normal. Of the remaining four, two had neuro-developmental problems before being given MMR, one had behaviour problems and one had a cerebral astrocytoma. There had been eight reports of nerve deafness although one was pre-MMR; six needed further investigation. The over-all picture was that there were 3.7 cases per 100,000 doses of Urabe vaccine and no cases reported with the Jeryl Lynn vaccine. However, the MSD [Merck Sharp and Dohme] vaccine was generally not well accepted because of pain at the injection site. Urabe is the most reactogenic vaccine but some data suggested that it may also be the most immunogenic. It was impossible to make a firm decision about this until all information had been collected.” (Note: it ought to be asked why the UK health authorities thought it was appropriate to vaccinate children with neurodevelopmental problems and cerebral astrocytoma with a vaccine that had caused substantial worries to them over its association with adverse reactions affecting the brain). (7.2 Discussions with Manufacturers) “Dr Salisbury reported on his recent meetings with Merieux, MSD and SKB [Smithkline Beecham]. Information was shared and details of adverse events discussed. The manufacturers felt that the Department’s line-that is, surveying adverse events and checking immunogenicity-was correct.” Again, the JCVI appeared to have adopted a passive approach to the problem and made no apparent efforts to identify specific sub-groups of children who may have been more prone to adverse reactions to the MMR. At the meeting that followed on 1st May 1992 (http:// www.dh.gov.uk/ab/JCVI/DH_095050), the same conclusions were reiterated in light of the continuing MMR crisis, with an additional concern that the actual number of vaccineassociated aseptic meningitis cases might have been higher, due to suspected underreporting: (7.4 Report of North Herts Immunogenicity Study (Dr Elizabeth Miller)) “The report of a cluster of CSF mumps virus positive cases in Nottingham had caused concern that national surveillance may have been underreporting the incidence of cases; a meeting had been held to discuss the Nottingham situation and the national data....In Nottingham all children with febrile convulsions were lumbar punctured, unlike some other areas from where reports had been received (Preston and Ashford) .The Committee agreed that no conclusion could be reached until the full immunogenicity results were available as well as the full analysis of the Nottingham and other data.” In the meantime, no changes were made to the immunisation policies. Would a seemingly passive approach to child health and safety, suggest that the JCVI in essence agreed to the fact that during the surveillance for the purposes of “for information only”, some cases of BSEM March 2011 The Health Hazards of Disease Prevention 9 suspected vaccine-induced convulsions, meningitis/encephalitis and deaths in children would just have to be tolerated? Note also that for using the same technique of lumbar puncture, 18 years later, Dr Andrew Wakefield who investigated a consecutive series of children with chronic enterocolitis and regressive developmental disorder which appeared to have been linked to MMR vaccination, was charged and found unfit to practice medicine by the UK General Medical Council (GMC). According to the GMC hearing, lumbar puncture in children with MMR-suspected adverse neurological outcome was apparently ”not clinically indicated” (http://www.gmc-uk.org/static/documents/content/ Wakefield__Smith_Murch.pdf). In July 1992, the data from Nottingham became available, nonetheless, it took another two months before the JCVI and the DH finally decided to take action, apparently not so much because of safety concerns but more so because of the legal advice given to the manufacturers by their lawyers in response to which the manufacturers decided to stop producing the Urabe-9 containing MMR vaccines. According to the transcript of the JCVI meeting on 6th November 1992 (http:// www.dh.gov.uk/ab/JCVI/DH_095050): (8.1 Report to Sub-Committee on SEAR/CSM: Dr David Salisbury) “In August, Department of Health officials met with MCA [Medicines Control Agency] and the manufacturers. At the end of August SKB, acting on the advice of their lawyers, decided to stop producing vaccine and advise licensing authorities world wide accordingly; the Department had, therefore, to act quickly.” Thus, only when the alarm was sounded by the manufacturers’ lawyers did the DH sense that the matters regarding the safety of the MMR vaccine required some urgency. In addition, it appears that the principal preoccupation of the European Authorities was how to preserve global vaccine policies in face of the Urabe-9 scandal. “On the 3 and 4 September the Chief Medical Officers of European Community countries were advised in confidence of the situation at a routine meeting. ARGOS/SEAR [Sub- Committee on Safety, Efficiency (SEAR) and the Adverse Reaction Group of SEAR (ARGOS)] agreed on 4 September that no action would be taken to revoke the manufacturer’s license as a change of purchasing policy was to be made by the Department; revoking the license would have caused a world-wide vaccine crisis.” The actual rate of aseptic meningitis after the MMR vaccination was discussed later on the JCVI 6th November 1992 meeting agenda (http://www.dh.gov.uk/ab/JCVI/DH_095050): (8.7 Risk of aseptic meningitis after MMR vaccination in UK children: Dr Elizabeth Miller) “The overall risk of this complication in the UK was 1 per 10,000 immunised children but, in Nottingham, this had increased to 1 in 4,000. Tests in Canada in 1989 had associated the Urabe vaccine with meningitis. The linking of laboratory records of CSE samples with district computer databases on immunisation had been very effective. The Committee was told that all the countries which had had a choice had switched from the Urabe to Jeryl Lynn;” What is rather astonishing is that the four-year old Canadian concerns over the safety profile of the MMR vaccine (which had been confirmed in 1989), were apparently ignored by the JCVI or at least, not given much credence. While the Canadian Health Authorities suspended the use of the Urabe-9 MMR in 1988, the UK introduced it along with a vigorous promotional campaign. In a confidential meeting of the JCVI Working Party on the introduction of measles, mumps, rubella (MMR) vaccine on 11th February 1988 (http://www.dh.gov.uk/ab/JCVI/DH_095297): (5. MMR vaccination in Canada) “Members read a report of cases of mumps encephalitis which had been associated with MMR vaccine containing the URABE strain of the mumps virus. The Canadian authorities had suspended the licences of MMR vaccines containing the URABE strain, but Dr Salisbury considered that the data on which the decision had been based was slender.” BSEM March 2011 The Health Hazards of Disease Prevention 10 The JCVI also had a specific plan to combat any adverse publicity in case any of this “confidential” information was to reach the public: “A statement would be prepared in anticipation of any adverse publicity which might arise.” (7. Publicity) “A paper prepared by the MMR Publicity Group was presented, by Mr Flaherty and Mr Reid, for the Group to discuss and to approve the general approach it contained. Dr Ross considered that the priority was to get the message across to doctors, health visitors and nurses.” Finally, the JCVI also had a number of funding strategies in place to promote the introduction of the MMR: (9. Funding situation) “£800,000 had been set aside for publicity and £1.4 million had been set aside to cover the period October 1988 - March 1989 to assist health authorities with increased vaccine costs, the education of professionals and for the re-programming of child computers. Members noted that the Statement of Fees and Allowances would need altering to include item of service payment for MMR.” This latter strategy was further refined on the JCVI Working Party on the introduction of MMR vaccine following meeting, on 17th May 1988 (http://www.dh.gov.uk/ab/JCVI/DH_095297): (3. Matters Arising) “Dr McGuiness suggested that instead of an item of service payment GPs might be paid according to their immunization rates.” In spite of carefully elaborated advertising and substantial investments, the JCVI did not entirely succeed in countering public concerns over vaccine safety, as on 6th October 1989 (http:// www.dh.gov.uk/ab/JCVI/DH_095294): (5.2.6) “The meeting’s further sadness was expressed over the press reports, which could have harmful implications and unnecessarily damage public confidence in vaccines.” Regrettably, similar sadness was apparently not expressed by the JCVI members over a report of a vaccine-suspected death of a 16 month old child, which was discussed at the same meeting. Rather: (5.2.4) “This was a fiscal case and as such was highly confidential. Doubts were expressed about the cause of death, and while it was not possible to give clear judgement, it was felt that there was unlikely to have been a causal relationship with the vaccine and that this was an unusual case.” Science should be based on facts and experimental evidence, not feelings. As for the alleged “slender” Canadian data on safety hazards of the SKF (Smith Kline and French) Urabe MMR vaccine, in a confidential JCVI CSM/DH Joint Sub-committee on Adverse Reactions meeting on 7th March 1990 (http://www.dh.gov.uk/ab/JCVI/DH_095294) the following was disclosed: (6. Adverse reactions to MMR vaccine) “In Canada, the MSD vaccine had been used exclusively [Jeryl Lynn strain-containing MMR]. Following the introduction of SKF product, the cases of meningoencephalitis had been BSEM March 2011 The Health Hazards of Disease Prevention 11 reported. When distribution of the SKF vaccine was halted, no further cases of meningoencephalitis were reported.” Yet, from this clear evidence, the JCVI derived a conclusion that somewhat seems to defy logic: “It was suggested that, due to different reaction criteria and methods of data collection, reporting in different countries should not be compared.” In summary, the JCVI endorsed and promoted a policy of vaccinating every child in the UK with the Urabe-9 MMR vaccine, in spite of the evidence that this would have caused a greater risk of encephalitis in children, when compared to the alternative Jeryl Lynn version of the MMR. It was only under pressure from a potential legal action that the JCVI and DH decided that it was due time “to act quickly” and withdraw the Urabe MMR from use in routine vaccinations. 2) Significantly restricted contraindication to vaccination criteria in order to increase vaccination rates despite outstanding and unresolved safety issues. Already in the early 1980s, the public confidence in the safety of the whooping cough (pertussis) vaccine has been eroded and since the uptake of the vaccine was relatively low, the JCVI sought ways to improve immunisation rates. According to Sir Charles Stuart-Harris, at the JCVI meeting on 3rd November 1981 (http://www.dh.gov.uk/ab/DH_095169) in section 5 on Whooping Cough: (5.c. Whooping Cough Vaccination Campaign) “...a 40% uptake of the vaccine ensured continuance of the disease; the uptake rate had to be improved.” The transcripts of the JCVI meetings from 1981 to 1986 indicate that the Committee did not know what was the risk/benefit balance of whooping cough vaccination in children who were potentially more at risk of vaccine associated-adverse outcomes. In spite of this, the JCVI went on with restricting contraindication criteria so that more children could be vaccinated. The JCVI also seemed to have been more preoccupied with protecting the "reputation of the vaccine" rather than protecting potentially vulnerable individuals, as the former served a basis for defining certain contraindication criteria. In 1981, a Working Group on Contra-indications to Whooping Cough Vaccination had been set up because ARVI, which had been asked by the JCVI to consider contraindication to whooping cough vaccine, had not been able to reach an appropriate agreement on this issue. At a beginning of the meeting of this Working Group on 1st May 1981 (http:// www.dh.gov.uk/ab/JCVI/DH_120115), it was noted that: “It was extremely important that the present meeting should reach an agreed conclusion because the reports on whooping cough were to be published on the 12 May, and it was desirable for any new contra-indications to be ready as soon as possible after this date.” and: “When considering the question of contraindications, the general principle to be borne in mind was that the right balance had to be struck between the need to keep acceptance rates for vaccination as high as possible and the need to protect groups of children who had an increased risk of adverse reaction to vaccination.” Assuming that the whooping cough vaccine is effective in preventing whooping cough, this principle indeed appears to be sound. Curiously however, one of the first items to be discussed under this agenda was that of respiratory illnesses and whether these should be regarded as a contraindication to whooping cough vaccination. Some members thought that respiratory illnesses ought to be deleted from the list of contraindications. Others however: BSEM March 2011 The Health Hazards of Disease Prevention 12 “...thought that the reference to respiratory disease was not really a contra-indication; rather it was a move to protect the reputation of whooping cough vaccination by avoiding an association between vaccination and SIDS.” Since apparently: “Respiratory illness was often associated with SIDS, and therefore the reference to respiratory disease was a wise precaution to prevent SIDS and whooping cough vaccination being associated.” Next: “Professor Miller stressed the need to maintain public confidence in the vaccine and said there was a need to prevent children with epilepsy being vaccinated in order to avoid an apparent association between vaccination and fits.” In addition: “The Chairman asked members to consider “History of seizures, convulsions, or cerebral irritation in the neonatal period”. Professor Hull said that this contra-indication would include children with disguised brain damage; this was good for the reputation of the vaccine in that it prevented an apparent association between vaccination and the discovery of brain damage.” It is somewhat perplexing why in discussing contraindication to whooping cough vaccination, the Working Group members entrusted with an “extremely important” task to reach a prompt agreement on this issue, appeared to have been more concerned about the reputation of the whooping cough vaccine, rather than the risk/benefit balance of whooping cough vaccination in children who were potentially more at risk of vaccine associated-adverse outcomes, especially since: “It was agreed that the risk/benefit balance in this group of children was not known.” Nonetheless, Dr Griffiths in referring to a paper from the US, in which children with a history of convulsions were immunised against whooping cough and then followed up noted that: “...this data did show a slightly increased risk of convulsions following vaccination in children with a previous history of convulsions.” In the ensuing discussion, members also considered whether a family history of epilepsy or other diseases of the central nervous system should be regarded as a contraindication to whooping cough vaccination and: “There was general agreement that including other diseases of the central nervous system was unnecessarily restrictive, and that this particular contra-indication should be deleted.” Whether such contraindications were indeed “unnecessarily restrictive” and whether the need to rush an agreement on this issue was justified in the light of the data available at that time, remains questionable following the observations made by Professor Gilliatt at the subsequent meeting held on 3rd November 1981 (http://www.dh.gov.uk/ab/ DH_095169): (5.d. Comments on Professor Stewart’s letter) “In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event...The Chairman concluded that much was not known about the natural history of brain damage in the young.” On 30th January 1986 at the Joint Working Party of the British Paediatric Association (BPA) and the JCVI Liaison group meeting (http://www.dh.gov.uk/ab/JCVI/DH_120115), concerns BSEM March 2011 The Health Hazards of Disease Prevention 13 were expressed over the low rates of whooping cough vaccination due to contraindications which may have exempted children who had a family history of seizures. In discussing cases in whom whooping cough vaccination is not absolutely contraindicated but who require special consideration as to its advisability (item 4.8): “Professor Gillliatt said that there had been a paper published recently in America, History of convulsions and the use of pertussis vaccine. Harrison C Stetler et al. Journal of Pediatrics 1985; vol 107; pages 175-179 which indicated that there was a quite high incidence of a family history of convulsions among the first degree relatives of children who had febrile convulsions. Members observed that changing this recommendation might decrease the number of children available for vaccination against whooping cough.” By November 1986, the JCVI had a quite remarkable solution to deal with the “problem” of reduced uptake of the pertussis vaccine: the suggestion was to alter the advice on contraindication criteria. According to the transcript of the 7th November 1986 JCVI meeting (section 3.5.2a; http:// www.dh.gov.uk/ab/DH_095169), the groups of children in whom the advisability of Whooping Cough vaccination required special consideration included: i) Children with a documented history of cerebral damage in the neonatal period. ii) Children with a personal history of convulsions. iii) Children whose parents or siblings have a history of idiopathic epilepsy. iv) Children with developmental delay thought to be due to a neurological defect. v) Children with neurological disease. It is further noted in the same transcript that: “There was considerable discussion on 3.5.2(a)” the details of which had not been given but: “it was finally agreed that for (iii), it should be stressed that the risk was very slight and that (iv) and (v) should be combined under “children with neurological conditions which are stable” and “not a contraindication”, ie in 3.5.4.” [their emphasis added-underlined] Based on no apparent scientific evidence the JCVI claimed that neurodevelopmental delays or neurological disorders were in fact stable conditions and as such, unlikely to be exacerbated by vaccinations. It would appear that the sole purpose of this potentially misleading claim was to reassure parents, who otherwise might have been deterred from vaccinating their child against pertussis, of the safety of pertussis vaccination. The same would apply to the JCVI statement regarding the alleged “very slight” risk of adverse reactions in children with family history of idiopathic epilepsy. One has to wonder whether the notes of the “commercial in confidence” CSM/JCVI/Joint Sub- Committee ARVI meeting on 3rd October 1986, later obtained through FOI (which discussed among other “not be disclosed” items, suspected adverse reactions to DTP vaccines given alone or with O P V ; h t t p : / / w w w. d h . g o v. u k / e n / F r e e d o m O f I n f o r m a t i o n / Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), would have had the same “reassuring” effect on parents had they been made publicly available at that time, or promoted with the same vigour as the vaccination campaigns: “During the current period [13th May 1986 to the 11th September 1986] 95 suspected adverse reactions were reported. These included: i)Death 151828. A 16 month old girl who two days after her first dose of DTP in mid-July 1985 was found to have a fever and a possible respiratory tract infection. Two days later BSEM March 2011 The Health Hazards of Disease Prevention 14 she had a major fit and was admitted to hospital where further convulsions occurred. Further fits occurred at the end of July 1985 and she died on the 1st of August probably from pneumococcal septicaemia. This patient had a family history of idiopathic epilepsy.“ This case has been reported to previous meetings of ARVI. ii)There were 8 reports of convulsions following vaccination including 165236, a patient who was in status epilepticus within hours of receiving her third dose of triple vaccine.” (7. Summary of Suspected Adverse Reactions to Vaccines, a.) It should be noted that the adverse reactions from OPV alone were no less severe and in fact more easily specifically attributed to the polio vaccine: “A six month old girl who developed recipient vaccine-associated poliomyelitis 30 days after receiving her first dose of oral polio vaccine.” (7. Summary of Suspected Adverse Reactions to Vaccines, c.) At the same meeting, the CSM/JCVI/Joint Sub-Committee ARVI discussed the results of a National Childhood Encephalopathy Study (NCES) as these were the subject of court proceedings on pertussis vaccine-related injury that were ongoing at that time: (5.1.1.) “The working party had established that the final number of cases in the NCES was 1,167. 39 cases had received triple vaccine in the week prior to the onset of their neurological illness (9 with infantile spasms, 18 with convulsions, and 12 with encephalopathies). These vaccine-associated cases included 5 patients (4 with convulsions and 1 with infantile spasms) who had a history of neurological events before immunisation which indicates possible prior abnormality.” Again, one has to wonder whether these five patients also fitted in the JCVI’s criteria of “stable” neurological conditions. The apparently lenient attitude with regards to vaccine safety on behalf of the JCVI is perplexing, particularly in light of their admission which followed the brief discussion about the significance of the NCES findings the CSM/JCVI/Joint Sub-Committee ARVI: (5.1.3.c.) “From the above there is reason to believe that the increased relative risk of prolonged convulsions after DTP was a real one.” Is this supposed to be a reassuring statement for all those children with prior family history of epilepsy or those suffering from “stable” neurological disorders, who as a result of the JCVI’s decision to shrink the contraindication criteria, no longer had a choice to opt out from pertussis vaccination? In further “reassurance”, the following was noted in the transcript of the CSM/JCVI/ Joint Sub-Committee ARVI meeting on 3rd October 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306): (5.1.5.) “Queries had been raised with regard to long-term sequelae after vaccine-associated encephalopathy...Among 12 children with encephalopathy there were 2 deaths, and 5 children with impairment of varying severity at 1 year. The relative risk for an acute vaccine-associated illness (convulsions or encephalopathy) was 3.3, and was similar irrespective of degree of impairment.” Thus, according to the JCVI’s own admission, not only was the risk of DTP-associated neurological complications a real one, it also appeared to be a relatively high risk. A somewhat lenient approach to contraindication criteria was also used with vaccines other than DTP in order to boost vaccination rates. (12. BPA/JCVI Working Group) BSEM March 2011 The Health Hazards of Disease Prevention 15 “In the matter of alleged egg allergy and measles vaccine, it was noted that although it was possible to amend the advice contained in the Memorandum ‘Immunisation against Infectious Disease’, it was also desirable to encourage manufacturers to change the advice in their data sheets.” (Meeting on 25 April 1986; http://www.dh.gov.uk/ab/DH_095169) In other words, the JCVI appeared to be rather unwilling to change their own advice in the Memorandum and instead suggested that manufacturers should be “encouraged” to do so. The following Section (3) indicates that the JCVI elaborated a very simple solution for boosting vaccine uptake in face of impediments posed by contraindication criteria: restrict the contraindication criteria, rewrite information in the Memorandum and ask the pharmaceutical companies to change their data sheets as to “avoid confusion” and possible legal action. 3) On multiple occasions requested from vaccine manufacturers to make specific amendments to their data sheets, when these were in conflict with the JCVI’s official advice on immunisations. That boosting vaccine uptake appeared to be the major force driving the JCVI’s decision process, can be inferred from their request to the manufacturer of the MMR vaccine Merieux to modify the data sheet information related to contraindication to adverse effects, at the 1st May 1987 meeting (http://www.dh.gov.uk/ab/DH_095169). Apparently, it was not sufficient to amend existing information on immunisation in their Memorandum to Infectious Diseases, it was also necessary to make that information concordant with the advices stated on manufacturer’s data sheets: (7.2 Report of the meeting of the Working Party held on 25 February 1987) “It was also noted that the data sheet for the Merieux MMR vaccine contra-indicated the use of the vaccine in children with a past or family history of convulsions. Medicines Division would be asked to approach Merieux to ascertain whether they would be willing to adopt appropriate modification to this data sheet.” At a later meeting on 23rd October 1987 (http://www.dh.gov.uk/ab/DH_095169), the JCVI also pressed for a change in the pertussis vaccine licensing details from the manufacturers, in spite of a pertussis vaccine-suspected injury litigation that was ongoing at that time. The Chairman of the JCVI approached the Association of British Pharmaceutical Industries to resolve this issue. The notes on this meeting state that: (15.2) “The meeting considered revised contra-indications to pertussis vaccine in parallel with those at present published; ARVI was aware of the potential difficulties in relaxing the contra-indications to pertussis vaccine and suggested that the papers be sent to the CSM and also to the manufacturers. The latter, in a written response, replied that it was not possible at present to change the product license details whilst litigation was in progress.” The “potential difficulties” that ARVI was concerned about were related to the ongoing pertussis litigation (this becomes more evident from the notes of a confidential meeting on 6th July 1987 cited further below). Unable to get the manufacturers to comply with their request, the JCVI turned to the Solicitors Branch in the Department of Health and Social Security (DHSS), to seek advice over: “...the difficulty of reconciling revised contra-indications to pertussis vaccine with advice issued by the manufacturers.”(18. Meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries; JCVI meeting 23rd October 1987; http:// www.dh.gov.uk/ab/DH_095169) The advice from the Solicitors was that: BSEM March 2011 The Health Hazards of Disease Prevention 16 “...such a discrepancy was not a problem for the JCVI whose function was to give advice to medical profession in the light of the best available knowledge.”(19. Memorandum “Immunisation Against Infectious Disease; JCVI meeting 23rd October 1987; http:// www.dh.gov.uk/ab/DH_095169) Notably, the “difficulty of reconciling revised contra-indications to pertussis vaccine” had been previously discussed by the CSM/JCVI/Joint Sub-Committee ARVI, on 6th July 1987, in yet another meeting that was noted as “commercial” and “in confidence”. According to this transcript which has been obtained through FOI (http://www.dh.gov.uk/ en/FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306): “The Chairman reminded members that the proceedings, papers, and information before them were confidential and should not be disclosed.” The same transcript also reveals the reason why the JCVI made great efforts to obtain the manufacturers’ compliance to their request to amend the data sheets on the pertussis vaccine and why, failing that, they sought help from the DHSS Solicitors. It was not necessarily because their policy was ethically and scientifically sound, but possibly because they were anxious about potential legal repercussions. (Note that the names of the participants have been redacted from the transcript prior to its release under the FOI section at the JCVI website, so that the comments made are unattributable to particular members): (6.4 JCVI’s revised contra-indications to pertussis vaccine) “The Chairman stated that JCVI had produced more permissive guidance on contraindications to pertussis immunisation and that the revised contra-indications, shortly to appear in the next version of the Memorandum ‘Immunisation against Infectious Disease’ would not conform with the manufacturers data sheet. This might lead to confusion for general practitioners and other vaccinators and there might be legal problems. ________ commented that both the JCVI and the JCVI/BPA Working Party had tried to improve guidelines to give specific contra-indications but an attempt should be made to reconcile these with data sheets and product licenses. Delay in the new Memorandum might be worthwhile in order to obtain manufacturers agreement to changes in data sheets and also to give the BNF [British National Formulary] the opportunity to change its advice. _________ agreed with _______ and welcomed the clearer advice from JCVI on pertussis contraindications which he endorsed.” The discussion that followed seems to indicate that ARVI was indeed nervous about potential legal implications, as apparently, they tried to evade having any responsibility on this matter: “________ commented there was no need for JCVI advice to change but there should be awareness of the implications of change. _________ suggested a meeting with the manufacturers to discuss the changes in an attempt to seek common ground. __________ commented that it was not ARVI’s responsibility to dismantle other groups instructions. ________ noted that ARVI had responsibilities to both JCVI and CSM and asked that pertussis section of the revised Memorandum should be submitted to the CSM for endorsement and then to the Licensing Authority to discuss with manufacturers so that the data sheets and the Memorandum would be compatible. __________ suggested that advice should be followed and that members should submit their comments in writing to the Chairman. _________ hoped that there could be informal discussion with the manufacturers of areas of agreement or debate and __________ noted that the new pertussis guidelines would be produced at a time of a continuing pertussis litigation._________ asked if there was likely to be a change in pertussis vaccine in the near future as this might promote difficulties if the contra-indications were also to change._______ agreed that the pertussis section should be sent to CSM....” BSEM March 2011 The Health Hazards of Disease Prevention 17 The following “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting held on 2nd October 1987 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), reveals how the CSM dealt with the burden of responsibility over the revised pertussis contraindications issue: (6.4 JCVI’s Revised Contra-indications to Pertussis Vaccine) “_________reported that the discrepancy between JCVI recommendations and manufacturers product licenses had been discussed at CSM who had upheld JCVI’s right to issue advice to the profession.” “_________reported that a meeting was shortly to be held with the Pharmaceutical Industry to find common ground on issues such as this. _________stated that DHSS Solicitors views of this discrepancy had been sought and had been advised that there was no obligation on JCVI’s views to conform with the manufacturers product licenses when those views represented the advice of expert medical opinion.” We see here that unlike the manufacturers, the CSM had endorsed the proposed revisions of contraindications to pertussis vaccine and their view was held by the DHSS Solicitors as superior to that of the vaccine Licensing Authority. This indeed is the case, since in the UK licensing process when applying for a licence, the pharmaceutical company will first submit a file to the Medicines and Healthcare products Regulatory Agency (MHRA) and the CSM within the MHRA will then review the application and produce an independent assessment. Following that, the CSM will issue a recommendation to the Licensing Authority that a licence is granted (http://www.ukmi.nhs.uk/ Med_info/licensing_process.pdf). The CSM’s competence as a body of medical experts and the reliability of their advice can be assessed from the notes of the preceding “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting, held on 6th July 1987 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306): (6.1 Whooping cough) “In conjunction with Tabled Paper 1 and an unnumbered agenda paper the Secretary summarised the present position regarding the Loveday litigation for the benefit of new members. He explained that in February the CSM had called for ARVI’s advice about updating the statement made in the 1981 report on Whooping Cough (HMSO) about a possible link between DTP immunisation and serious neurological illness. It had been hoped that by this means ‘discovery’ of all the relevant JCVI, CSM and ARVI documentation on whooping cough vaccine could be avoided. However, by the time ___________ could report a revised statement to CSM (see minutes of February 1987 meeting) it was already clear that nothing could be done to avoid ‘discovery’. Subsequently, the Chairman of CSM asked ARVI to keep a watching brief on the situation, and to let the Main Committee know if at any time it was thought possible to modify further the statement.” The contents of the controversial statement that the CSM appeared to be eager to modify, in order to avoid potential legal consequences, have been disclosed to the JCVI/Joint Sub- Committee ARVI members on “commercial in confidence” meeting on 6th February 1987 obtained through FOI (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306): The notes of that meeting in the section “7.1 Whooping cough vaccine –CSM advice” read: “No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist. We would also agree that the evidence suggests that the vaccine causes convulsions in some children.” BSEM March 2011 The Health Hazards of Disease Prevention 18 Thus, the “best available knowledge” on which the CSM “upheld the JCVI’s right to issue advice to the profession on restricting contraindication to pertussis vaccination can be summarized as follows: Both the CSM and the JCVI/Joint Sub-Committee ARVI seemed to have been fully aware of the fact that the pertussis vaccine could cause convulsions and adverse serious neurological outcomes in a sub-set of children. Apparently, the CSM and the JCVI/Joint Sub-Committee ARVI have then attempted to avoid “‘discovery’ of all the relevant JCVI, CSM and ARVI documentation”. Does this suggest that the top UK authorities responsible for sound vaccination policies were not as much concerned about putting certain children at risk of serious vaccine-induced neurological harm, as they were of legal repercussions that might have followed in the event that any of the “relevant” documents were to reach the public? Finally, rather than being in line with public health interests, those responsible for the safety of medicines and sound vaccination practices appeared to have been more aligned with the interests of vaccine manufacturers. This is implied by the following discussion from the transcript of the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting held on 6th June 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), at which members of the US Centers for Disease Control (CDC) were also present. In discussing the significance of the NCES report on pertussis vaccine injury it was noted: (6. Litigation and pertussis vaccination) “6.1_______ referred to the June issue of the American Journal of Diseases of Childhood. He said that between 18 and 22 million doses of DPT were manufactured annually in the United States prior to the difficulties concerning whooping cough vaccine and litigation... Since 1985, the price of the vaccine has risen from 40 cents per dose to $ [unreadable] per dose in 1986 and it is expected to rise to $11 per dose. Litigation claims per year have risen from virtually nil in 1978/79 to over 219 in 1985, claiming [unreadable] billion US dollars, and litigation suits follow a similar pattern. The total amount claimed has likewise increased greatly.” “6.2_______said that out of court settlements had not been included in these figures. It was difficult to protect manufacturers against such heavy compensation claims. The situation had been aggravated by an organisation called ‘Dissatisfied Parents Together’. The Hawkins Congressional Commission suggested that claimants might go into a system with a Panel and if accepted would be given an award of $1 million or alternatively accept court settlement. There was also a Bill before the American Government which suggested that punitive damage be done away with and that damages for pain and suffering only be awarded.” Over the subsequent years the trend of restricting contraindications criteria by the JCVI in order to increase vaccination rates continued. On 20th October 1988 (http:// www.dh.gov.uk/ab/DH_095169): (6.2 Health Education Authority (HEA) publications on MMR) “Members pointed out that the Data Sheet for MMR vaccine suggested that it should not be given before the age of 15 months and also that the vaccine should be given subcutaneously (and not by deep subcutaneous or intramuscular injection as suggested in the Memorandum). The difficulties of changing the Data Sheets to agree with the advice in the Memorandum “Immunisation Against Infectious Disease” were discussed.” What also continued is the JCVI’s confidential meetings with vaccine manufacturers, which appeared to be focused on vaccine policy and business rather than child health and safety. In reference to the meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries, the transcript of the JCVI meeting on 23rd October 1987 (http:// www.dh.gov.uk/ab/DH_095169) states: “Also discussed was the availability of scarce vaccines and the introduction of new vaccines into more regular use. The question of financial support for training members of the health BSEM March 2011 The Health Hazards of Disease Prevention 19 service in immunisation was also discussed.” (18. Meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries) It ought to be asked why the Chairman of the JCVI deemed as appropriate for members of health services to be financially supported by the vaccine manufacturers. On further relations between the JCVI and vaccine manufacturers, the transcript of the JCVI meeting on 4th May 1990 (http://www.dh.gov.uk/ab/DH_095169) reveals that: (2. iv.) “The Chairman said that Departmental officials had recently met vaccine manufacturers who were keen to be informed, in confidence, of the outcome of JCVI discussions which might affect their own plans. Agreement was sought from the committee on the appropriateness of a summary of such discussions, cleared by the Chairman, being provided to manufacturers. The Committee agreed to this. In connection with this Professor Hull brought to the Committee’s attention a recent letter he had received from a GP, the contents of which indicated, and the Chairman and committee agreed, a continuing communication problem on the relationship between JCVI advice and manufacturer’s data sheets. Dr Salisbury said he was aware of this particular correspondence.” Incidentally, this is the same Professor Hull who, 8 years later, on 6th July 1998, was prompted to write to Professor Zuckerman at the Royal Free Hospital in London, to express his concern about the work of Dr Andrew Wakefield, who investigated the histories of 12 children with regressive autism and gastrointestinal symptoms that appeared to be linked to the MMR vaccine (http://www.circare.org/autism/hull_zuckerman_19980706.pdf). In summary, by making persistent efforts in restricting vaccination contraindication criteria, so that more children could be vaccinated, the JCVI appeared to have prioritized vaccination policy over vaccine safety. In doing so, both the JCVI and the CSM (which actively supported the JCVI’s amendments) may have shown a disregard for the safety of children. Furthermore, together with ARVI and the CSM, the JCVI attempted to avoid “’discovery’ of all the relevant documentation” and thus perhaps evade potential legal repercussions. By seemingly siding with vaccine manufacturers rather than public health interests, the CSM/JCVI appear to have signally failed their fiduciary duty to protect individuals from vaccines of questionable safety and thus possibly shown incompetence in their role in the public health service. 4) Persistently relied on methodologically dubious studies, while dismissing independent research, to promote vaccine policies. Over the years, the JCVI has consistently promoted the MMR vaccine as safe, based on studies that have proven to be either irrelevant, inconclusive, or methodologically questionable. There was also a marked tendency by the JCVI to rely on epidemiological work to support the MMR policy. For example, in a discussion of a population-based study by Fombonne and Chakrabarti [5], which found no link between the MMR vaccine and autism, at the JCVI meeting on 2nd November 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044): (7.1) “The Committee agreed that this data from Dr Fombonne was persuasive and indicated that the frequency of regressive autism appeared not to have increased.” The problem with epidemiological studies is that they only test for “association” and not “causation”, thus providing unreliable estimates of true risks. Regarding the alleged safety of the MMR vaccine, the most comprehensive independent evaluation done on this subject, by the Cochrane Review (October 2005, http://www2.cochrane.org/reviews/en/ab004407.html), is hardly reassuring. BSEM March 2011 The Health Hazards of Disease Prevention 20 Although the Cochrane Review found no significant evidence of an involvement of the MMR with either autism or Crohn's disease, none of the 31 studies included in the review met the Cochrane Collaboration's methodological criteria. In fact, one of the major conclusions from the Cochrane's 2005 MMR review was: "The design and reporting of safety outcomes in MMR vaccine studies, both pre- and postmarketing, are largely inadequate." More specifically, referring to the 2001 Fombonne and Chakrabarti study which the JCVI regarded as “persuasive” in disproving the link between the MMR vaccine and autism, the Cochrane review made the following remark: "The number and possible impact of biases in this study was so high that interpretation of the results is impossible." While historically, the JCVI tended to be quick in accepting those studies which dismissed safety concerns over the MMR or other vaccines, it was inert in accepting those which indicated that concerns were warranted. At the JCVI meeting on 1st November 2002 (http://www.dh.gov.uk/ab/ JCVI/DH_095044), the members discussed recent scientific research on the MMR where: “The Committee was provided with recent research published on the safety of MMR, in particular the link with inflammatory bowel disease and autism. The following papers had undergone review by experts: 1. "Neuro-immunopathogenesis in Autism" V Singh. New Foundation of Biology 2001, 447-458. 2. Abnormal measles-mumps-rubella antibodies and CNS auto-immunity in children with autism. V Singh et al. Biomedical Science 2002; 9; 359-364 3. Small intestinal enteropathy with epithelial IgG and complement deposition in children with regressive autism. Torrente et al. Molecular Psychiatry 2002; 7(4);375-382 4. Development of an "allelic discrimination" type assay to differentiate between the strain origin of measles virus detected in intestinal tissue of children with ileocolonic lymphonodular hyperplasia and concomitant development disorder. O Sheils et al. Abstract presented at the Pathological Society of Great Britain and Ireland in July 2002. 5. Review article: the concept of entero-colonic encephalopathy, autism and opioid receptor ligand. A Wakefield et al. Alimentary Pharmacology and Theraputics 2002; 16: 663-674.” (10.2 Recent scientific research) The conclusions were: “that this new evidence did not alter the CSM view: there was no evidence to support a causal link between MMR vaccine and autism and bowel disease. JCVI found the papers helpful and expressed its strong support for the conclusion reached by the CSM.” As it will be evident from Section 8), the JCVI attitude towards vaccine safety, particularly the MMR, has not changed and to this day, the Committee still regards it as safe. On the other hand, independent research is accumulating to suggest otherwise. Only a year after the 1st November 2002 JCVI meeting, Singh and Jensen found more evidence to support an aetiological role of the measles virus component of the MMR vaccine in autism [6]. Using enzyme-linked immunosorbent assay, Singh and Jensen found that children with autism, unlike their siblings or normal children, had significantly elevated levels of measles antibodies in their sera. Antibodies against rubella and mumps did not significantly differ between these groups of children, however, immunoblotting screen against measles vaccine virus (source Merck&Co) showed that 43 out of 52 (83%) autistic children, but none of the 30 normal children or 15 siblings of autistic children, had antibodies against the measles vaccine virus. Since none of the children in Singh and Jensen study had any prior history of measles rash or wild type measles infection, but they all have had their immunisation with the MMR, the authors concluded [6]: BSEM March 2011 The Health Hazards of Disease Prevention 21 “This vaccine in a small population of genetically predisposed children may perhaps manifest an atypical measles infection that does not yield a clinical rash but produces neurologic symptoms similar to those seen in children with autism.” and “Although more research is necessary to uncover the etiology of autism, the hyperimmune response to measles virus might indicate virus reactivation that triggers a misguided humoral immune response in children with the disorder.” Finally, far from being “discredited” and “flawed” as suggested in latest editorials published in the BMJ [7], the “Wakefield’s hypothesis”, which indicates that there is “a pattern of colitis and ileallymphoidnodular hyperplasia in children with developmental disorders” [3], is now supported by more independent research [8-12]. Notably, several respectable publications suggest that the principal findings of the Wakefield’s 1998 Lancet study should not be discarded nor ignored. For example: Quigley and Hurley [13]: "Wakefield et al. are to be congratulated on opening yet another window onto the everbroadening spectrum of gut/brain interactions. Their findings raise many challenging questions that should provoke further much-needed research in this area, research that may provide true grounds for optimism for affected patients and their families." Most recently, at the meeting on 2nd February 2011 (http://www.dh.gov.uk/ab/JCVI/DH_123529), the JCVI dismissed the relevance of a paper by world-renowned autoimmunologists Professor Yehuda Shoenfeld and Nancy Agmon-Levin [14], which raised serious concerns about the role of vaccine adjuvants in vaccine-related autoimmune conditions. (XII. Papers for information and any other business, 61.) “The committee discussed a review paper by Shoenfeld and Agmon-Levin (2010) 3 on autoimmune/inflammatory syndrome induced by adjuvants, in particular on the role of adjuvants in the pathogenesis of four conditions: siliconosis, the Gulf war syndrome (GWS), the macrophagic myofasciitis syndrome (MMF) and post-vaccination phenomena. The committee considered that the paper did not provide convincing data on the role of adjuvants in these four ‘enigmatic’ medical conditions and that the review did not raise safety concerns about the use of adjuvants.” 5) Persistently and categorically downplayed safety concerns while overinflating vaccine benefits. The sharp increase in litigation claims over pertussis vaccine injury between 1978/79-1985, presented an additional challenge for the CSM/JCVI/Joint Sub-Committee ARVI, as increased efforts were now needed to reassure the public in the safety of the pertussis vaccine. In the transcript of the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting held on 7th February 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), ARVI made the following comments on a confidential paper: (Item 5.1 ARVI’s comments on ________ paper “Whooping cough disease, vaccination, vaccine damage”) “________ deprecated the use of the term ‘brain damage’ which the public might consider as a permanent entity. The public may not also understand the significance of febrile convulsions.” BSEM March 2011 The Health Hazards of Disease Prevention 22 Are we to assume that ARVI had not been aware of a certain controversial statement made by the CSM in the 1981 in a report on Whooping Cough about a possible link between DTP immunisation and serious neurological illness?: “No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist.” (JCVI/Joint Sub- Committee ARVI “commercial in confidence” meeting on 6th February 1987, section “7.1 Whooping cough vaccine –CSM advice”; http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306) Perhaps the reason why ARVI “deprecated the use of brain damage” is because of their firm belief that vaccines could not be associated with such events. Apparently, the possibility that vaccination could cause permanent brain damage must have been considered as an outrageous assertion, so much so that it did not even deserve scientific scrutiny. In fact, following a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis vaccine on 7th February 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), CSM/JCVI/Joint Sub- Committee ARVI jointly concluded that: (6.5.1) “It was considered unreasonable to ask paediatricians to report for a period of six years.” Under the same agenda, the CSM/JCVI/Joint Sub-Committee ARVI also decided that: (6.5.1) “No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.” Obviously without such a standard, it would have been quite impossible to assess whether vaccination against pertussis caused more severe brain damage than natural pertussis infection. If concerns about pertussis vaccination were indeed unsupported and only a product of an inexpert “perception of the public” as ARVI’s statements would led us to believe, then surely such a study would have just reinforced the notion that vaccines are safe. However, it appears that according to the CSM/JCVI/Joint Sub-Committee ARVI’s problem-solving rationale, instead of encouraging further research, it seemed more acceptable to downplay safety concerns over possible vaccine-injury, which then justified their decision to take no further investigation into the matter. Unwillingness to carry out this specific research is perplexing indeed, in light of what was noted at the 3rd November 1981 meeting (http://www.dh.gov.uk/ab/DH_095169) in section 5 on Whooping Cough: (5.d. Comments on Professor Stewart’s letter) “Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event...The Chairman concluded that much was not known about the natural history of brain damage in the young.” Are we meant to believe that “cessation of development” following episodes of vaccine-associated fits does not fit into the category of “permanent entity” and/or “brain damage”? As for the public’s alleged misunderstanding on the significance of febrile convulsions, the transcript notes of the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting held on 6th June 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306) are particularly enlightening: In discussing the significance of the NCES report on pertussis vaccine injury: (5.2 Encephalopathy) BSEM March 2011 The Health Hazards of Disease Prevention 23 “The report used the NCES estimation of relative risk of 3:1, it was estimated that one third of such cases have permanent handicap one year from their onset (as derived from the NCES).” (5.3 Complex Febrile Convulsions) “These were defined as being of more than 10 minutes in duration, or repetitive over 24 hours...Vaccine could cause such seizures and it was believed that 10 per cent of such complex seizures could result in permanent handicap...” Perhaps the public would have been better acquainted with the significance of febrile convulsions and the fact that pertussis vaccine could cause them, had not: “The Chairman reminded members that the proceedings, papers and information before them [were] confidential and should not be disclosed.” Paradoxically, at the prior meeting on 7th February 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306), at which ARVI stated it “deprecated the use of the term brain damage”, the CSM/ JCVI/Joint Sub-Committee ARVI acknowledged: (6.5.1) “that the NCES may have missed cases of severe neurological disease which progressed to handicap among children who were not admitted to hospital.” Going back to the meeting that followed, on 6th June 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306): (5.7) “In the general discussion which followed, some members of the Committee felt that the report [referring to the American Medical Association (AMA) panel report on Pertussis Vaccine Injury, published in JAMA 1985; vol 254, pages 3083-3084] not only accepted the fact that vaccine damage was a real phenomenon but implied (by the way it was written) that it was commoner than was believed to be the case in the UK.” Notably, according to the notes of the “commercial in confidence” CSM/JCVI/Joint Sub- Committee ARVI meeting on 3rd October 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306), the AMA panel report had been prepared: (5.2) “...with the particular intention of providing information for legislators as to what type of vaccine-associated event might require compensation, if Federal compensation for presumed vaccine injury were to be introduced.” Perhaps it is because of this that the CSM/JCVI/Joint Sub-Committee ARVI: (5.2) “...agreed that the document contained a number of assertions which could not be accepted.” One has to wonder whether such assertions unacceptable to the CSM/JCVI/Joint Sub- Committee ARVI include: “...the fact that vaccine damage was real a phenomenon” and “commoner than was believed to be the case in the UK.” (CSM/JCVI/Joint Sub-Committee ARVI meeting on 6th June 1986; item 5.7; http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306) BSEM March 2011 The Health Hazards of Disease Prevention 24 Other than perceiving health hazards associated with certain vaccines as a danger to overall routine immunisations, the JCVI felt that certain health professionals were also negatively affecting the vaccination policy by exercising more caution with regards to contraindication criteria than the JCVI deemed appropriate (for a remainder of the JCVI’s position with regards to contraindication criteria refer back to Sections 2) and 3)). In a Summary Report on an investigation of failure to reach a measles immunisation uptake in the Maidstone Health Authority, at the Joint Working Party of the BPA and the JCVI Liaison group meeting on 30th September 1986 (FOI release, 86/3rd meeting; http:// w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t i o n / Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4140335), the member whose name was erased from the transcript commented that: (7.) “...the paper described a position which was still bedevilled by false contra-indications to measles vaccination.” Apparently, “________ commented that often parents wanted the vaccine given but were dissuaded by health service staff. ________ stressed the need for training of health professionals and the Chairman considered that the ‘responsible person’ in each district (quoted in previous circulars) should organise such a training.” (7. Measles vaccination: Summary Report on an investigation of failure to reach a measles immunisation uptake in the Maidstone Health Authority) In a later meeting (JCVI 7th November 1986; http://www.dh.gov.uk/ab/DH_095169): (9. BPA/JCVI Working Group) “Members agreed that the most disturbing feature was that a minority of health professionals could exert a disproportionally bad effect on a campaign.” What the JCVI’s perception of a “responsible person” might be, is perhaps best understood in the light of their bewildering leniency towards vaccine safety and a seeming tendency to align with the manufacturers’ interests more than those of public health. By 18th November, the JCVI had an elaborate strategy to improve measles vaccine uptake (as documented in the transcript of the JCVI meeting on 1st May 1987; http:// www.dh.gov.uk/ab/DH_095169), which included: (discussion about a PHLS meeting on 18th November on the uptake of measles vaccine) “GP clinics where immunisations were given should be more attractive and use every opportunity of attendance at clinics to offer immunisation; this is especially important for deprived families.” It was also recommended that: “Regional and District Health Authorities (DHAs) should be accountable for their vaccination performance.” Since: “All the members agreed that accountability with regard to immunisation was most important. The Chairman is summing up said that immunisation was a most important NHS Policy and that recommendation before them, after editing, should be put to the NHS Management Board and then promulgated to the NHS with a separate copy to the nominated persons in the districts.” That “immunisation was a most important NHS Policy” is also implied in a discussion on whooping cough at the JCVI meeting on 3rd November 1981 (http://www.dh.gov.uk/ab/ DH_095169): BSEM March 2011 The Health Hazards of Disease Prevention 25 (5.d. Comments on Professor Stewart’s letter) “The meeting then considered Professor Stewart’s paper on deaths from whooping cough in Great Britain (JCVI(81)12). Dr Williams, referring to page 5 of the paper, said that deaths from whooping cough tended to be under-notified...On the other hand, at times of outbreaks of whooping cough the disease tended to be over-notified; this had the effect of lowering fatality ratio.” In the ensuing discussion: “The Chairman concluded that it would probably not be wise for the Committee to make a formal reply to this paper. (Members also thought that controversial replies to correspondence to the medical journals might not add support to the whooping cough vaccination campaign.)” In the following years, the members of ARVI continued to “express anxieties” over eroding confidence of the public in pertussis and other vaccines. In a Joint Sub-Committee ARVI meeting on 8th March 1988, the members recommended that a monitoring system for vaccine reactions should be set up, which would cope with any vaccine related “adverse publicity” (item 7, Adverse Reactions Surveillance; http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306; note that this meeting was incorrectly noted as March 1998 rather than March 1988). While the public appeared to have lost the confidence in the safety of the pertussis vaccine by the mid 80s, in 1989, the JCVI was still debating on whether or not the pertussis vaccine caused permanent brain damage. Referring to the NCES report it was generally accepted by the JCVI that if the vaccine led to severe neurological outcomes, it did so very rarely (JCVI meeting on 3rd November 1989; http://www.dh.gov.uk/ab/DH_095169). Finally, it was agreed that the statistical data of attributable risk should be removed from the Memorandum since, according to Dr Salisbury: “If the public was given a risk ratio — any ratio — they would still see it as a scientifically proven risk. It was therefore preferable not to use insecure figures if possible but to stress the benefits from vaccination.” (12.1 Whooping cough – article by Dr A H Griffith in Vaccine etc JCVI (89)32) Regarding the alleged overall “benefits from vaccination”, it is worth mentioning that in a discussion about Diphtheria outbreaks in immunised populations on 22nd April 1988 (http:// www.dh.gov.uk/ab/DH_095169), the JCVI acknowledged that these do in fact: (16.1) “occur in well-immunised populations...” In addition, the decision to include mumps in the routine vaccination schedule with the introduction of the MMR in 1988 goes against JCVI’s own past advice, as evidenced by a discussion about the usefulness of the mumps vaccine in the JCVI meeting on 11th December 1974 (http:// www.dh.gov.uk/ab/JCVI/DH_095052): (10.) “The Committee agreed that there was no need to introduce routine vaccination against mumps.” because “complications from the disease were rare.” Granted, opinions can change with time as new scientific evidence becomes available. Even so, the arguments are against routine mumps vaccination. Mumps in adults but not in children can cause mumps orchitis, a serious condition which may result in male sterility. Mumps outbreaks in older BSEM March 2011 The Health Hazards of Disease Prevention 26 individuals increased in frequency since the introduction of the MMR into the routine schedule, most likely because of the poor effectiveness of the mumps component of the vaccine. In a comprehensive assessment on mumps orchitis in the post-vaccine era, which included epidemiologic, clinical, therapeutic, and follow-up studies and outcomes of 609 patients, Ternavasio-de la Vega et al. [15] reported: “Mumps orchitis is the most common complication of mumps infection in young postpubertal males. Testicular compromise is characterized by an abrupt onset of unilateral or bilateral marked scrotal swelling and pain, accompanied by constitutional symptoms and fever. Immunization programs against mumps have reduced the number of reported cases and influenced their age distribution. Since the introduction of mumps vaccine in 1967 (the year the first mumps vaccine was licensed in the United States), a shift in the age of peak incidence of mumps from children aged 5-9 years, in the prevaccine era, to children and young adults aged 10-24 years has been observed. Serious complications have appeared as a consequence because of the higher rate of sequelae among the older age-group. The principal complication of acute mumps orchitis is the atrophy of germinal epithelium with spermatogenesis arrest, which in turns leads to male sterility.” The evidence for the poor effectiveness of the mumps vaccine has recently been reported by Castilla et al. [16]: “This study adds to the literature showing moderate effectiveness of the mumps vaccine containing the Jeryl Lynn strain, which seems to be related with early and progressive waning immunity. This effect, seen in children vaccinated with both one and two doses, makes it difficult to control the disease even when high vaccination coverage is achieved, and leaves open the possibility that outbreaks will occur when the infection is reintroduced.” “Our results indicate that this effect of waning immunity begins early, as seen in the fact that 3 or more years after the second dose of MMR vaccine, the risk of mumps was 10 times higher. This increased risk does not appear to be linear, but rather is accentuated over time.” Hence, routine mumps vaccination has shifted a childhood disease to adolescents and young adults, groups with a higher incidence of adverse long-term complications and sequelae. By contrast, the benefits of naturally acquired immunity against mumps in early childhood are life-long protection against mumps and its serious complications later in life. Curiously, at the meeting held on 17th September 1990 (http://www.dh.gov.uk/ab/JCVI/ DH_095294), the JCVI also acknowledged the consequences of shifting mumps infections to older age groups: (6.5) “It was noted that the introduction of mumps immunisation could in theory shift the age specific infection rates to the older age groups in whom the complications were greater;” However, the Committee concluded: “...nevertheless, the gains from the progressive reduction in mumps illnesses outweigh such concerns.” It would appear that in following the JCVI’s line of reasoning, one must conclude that the alleged benefit of eradicating mumps in young males where the illness is mild and “complications are rare”, outweighs the risk of male sterility. Similar to mumps, the complications from rubella early in childhood are minimal, hence it may be argued that vaccination against both rubella and mumps are of little clinical benefit to a child. Serious complications from rubella may occur in a developing foetus of a pregnant woman who has contracted rubella during her first trimester. In such cases a child may be born with congenital rubella syndrome (CRS), involving multiple congenital abnormalities. The risk of CRS can be reduced either by making sure all women have caught rubella as children or by vaccinating those BSEM March 2011 The Health Hazards of Disease Prevention 27 who have not prior to puberty. Hence, the current JCVI’s policy of vaccinating every child, male and female, against rubella does not appear to be justified. Finally, apart from “no need to introduce routine vaccination against mumps” , the decision to introduce the MMR into a routine schedule was in conflict with the JCVI’s past concerns about risks associated with simultaneous administration of multiple live vaccines. Curiously, the MMR vaccine developed by MSD was first licensed in the UK in 1972, but not marketed until 1988. An indication as to why it took 16 years to introduce it in to a schedule may be found in the same meeting which discussed the usefulness of the mumps vaccine (JCVI meeting, 11th December 1974; http:// www.dh.gov.uk/ab/JCVI/DH_095052): (11 Simultaneous administration of live vaccines (CHCS(VI)14)) “The Chairman refereed to the 3 vaccines which had been licensed for Merck Sharp and Dohme and asked for comments on the company’s claim that these could be administered simultaneously with live poliovirus vaccine. This use of the vaccine appeared to conflict with the Committee’s published advice and they had to consider (a) whether this advice should be changed and (b) if the vaccine concerned viz MMR, Biavax and Measles and Rubella virus vaccine and live MSD could be given with live poliovirus vaccine. Professor Dick and Dr Warin pointed out that an interval in the administration of live vaccines had been advocated in view of the probability of adverse reactions and because of the recent publicity surrounding adverse reactions. The Committee agreed that it would be inopportune to change the guidance that an interval of at least 3 weeks should be allowed to elapse between the administration of any 2 live vaccines whichever came first.” Perhaps unknown to most lay people as well as medical professionals is the issue of vaccine contaminants which is somewhat inherent to the vaccine production process. In this regard, one particular item discussed under the section 3.4. Ruminant and Human Materials used in Vaccine Manufacture, at the JCVI meeting on 4th May 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044), deserves special emphasis: (3.4.1) “This report was provided for information. The Committee asked by which date the vaccines already distributed would no longer include any whose production process may have involved the use of potentially BSE [Bovine spongiform encephalopathy] infected Category 1 or 2 material. The Committee was told that Category 1 material was only used at the master seed/working seed stage of the manufacture of a very few vaccines, not in routine vaccine production itself. Many vaccines are produced from master seeds which were manufactured many years ago...Master seed material often antedated the BSE epidemic in the UK, and was diluted many fold to the extent that any exposure to infected material, if ever present, would be remote.” How many people would feel comfortable with taking medicinal products derived from potentially BSE-contaminated material? As to why such vaccines continued to be used: (3.4.1) “There is reluctance to establish new master seeds for vaccines which have long history of use because such a change could possibly change the vaccine characteristics which may adversely impact safety and efficacy.” Indeed, removing sources of possible BSE contamination from vaccine manufacture would have no doubt “impacted safety”; it would have made vaccines safer. Curiously, when asked by the JCVI: (3.4.3) “...to consider whether it would be possible to put the information it had summarised on vaccine manufacturing and excipients in vaccines into the public domain; the MCA would consult their lawyers on this point.” BSEM March 2011 The Health Hazards of Disease Prevention 28 If there was no risk of contracting BSE from a vaccine, then why did the MCA have to consult their lawyers “on this point”? At the same meeting, on 4th May 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044), the Committee discussed: (4.5.1) “... suspected adverse reactions categorised as serious to DTP/Hib, polio, BCG, hepatitis A and B vaccines over the last three years. The data was based on Yellow Card reports received by the MCA.” and it showed the following: “i. DTP/Hib - the overall pattern and type of suspected reactions in 2000 were similar to previous years, with the exception of an increase in the number of respiratory reactions. Most of the increase appeared to be due to an increase in number of SIDS (5) and apnoea type reactions (14) being reported. ii. Polio - The types of suspected reactions reported in 2000 were on the whole similar to previous years. The only differences appeared to be an increase in the number of cardiovascular, eye and respiratory reactions reported. iii. BCG - Overall the types of suspected reactions reported were similar with the exception of an increase in number of cardiovascular reactions in 1999 and musculo-skeletal reactions in 2000. iv. Hepatitis B - The types of suspected reactions reported on the whole had been similar, with a notable decrease in the number of serious cardiovascular, eye, immune system, musculo-skeletal and neurological reactions being reported. v. Hepatitis A - The types of suspected reactions being reported were on the whole fairly similar. However, there were three notable differences: a significant increase in the number of cardiovascular and musculo-skeletal reactions reported in 2000, and a significant increase in the number of immune system disorder reactions reported in 1999. All these type of reactions were recognised side effects of this vaccine.” (4.5.2) “Overall, there were no new safety issues identified.” Perhaps these were not new issues, just old persisting ones. Nonetheless, in all but one case (Hepatitis B), the number of serious adverse reactions appeared to have increased and in some cases this was not only significant but also a “recognised side effect of this vaccine” (Hepatitis A). In spite of this: (4.5.2) “The Committee was not persuaded given all the inherent uncertainties of spontaneous reporting that there were significant problems developing.” If anything, the Committee previously appeared to have acknowledged that there were problems with underreporting of adverse reactions to vaccines. In a Report of North Herts Immunogenicity Study on the 1st May 1992 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), it was noted that “the report of a cluster of CSF mumps virus positive cases in Nottingham had caused concern that national surveillance may have been underreporting the incidence of cases...” As noted in the following Section (6), the Yellow Cards are a passive surveillance system, not routinely used by the GPs and hence, data on adverse reactions obtained through Yellow Card reports are likely to be an underestimate of the true rate of these events. Finally, since the principal rationale for shaping vaccine recommendations and policies according to the JCVI was to keep vaccination rates as high as possible so that presumably, “herd immunity” BSEM March 2011 The Health Hazards of Disease Prevention 29 would be achieved, it would seem fair at this point to question exactly how well has this concept been established? The theory behind vaccine-mediated “herd immunity” appears sound, it maintains that vaccination of a significant portion of a population (herd), will provide a measure of protection for individuals who have not developed immunity. Obviously, transmission of a disease to the point where it would reach an epidemic is expected to be countered in a population where most individuals are thought to be immune. However, the concept of vaccine-mediated “herd immunity” is based on the assumption that vaccines are effective in conferring immunity to the individual. If this were so, then how does one explain outbreaks of infectious diseases in populations where over 95% of individuals have been vaccinated? Gustafson et al. [17] “An outbreak of measles occurred among adolescents in Corpus Christi, Texas, in the spring of 1985, even though vaccination requirements for school attendance had been thoroughly enforced. Serum samples from 1806 students at two secondary schools were obtained eight days after the onset of the first case. Only 4.1 % of these students (74 of 1806) lacked detectable antibody to measles according to enzymelinked immunosorbent assay, and more than 99 % had records of vaccination with live measles vaccine...After the survey, none of the 1732 seropositive students contracted measles. Fourteen of 74 seronegative students, all of whom had been vaccinated, contracted measles. In addition, three seronegative students seroconverted without experiencing any symptoms. We conclude that outbreaks of measles can occur in secondary schools, even when more than 99 percent of the students have been vaccinated and more than 95 percent are immune” (Note that if the measles vaccine was effective in providing herd-protection, then the <5% of children in this study who did not seroconvert would still have had protection from contracting measles. The whole premise on achieving high vaccination rates rest on the assumption that the herd will protect those vulnerable individuals who have not been vaccinated, or do not seroconvert.) Hersh et al. [18] “In early 1988 an outbreak of 84 measles cases occurred at a college in Colorado in which over 98 percent of students had documentation of adequate measles immunity (physician diagnosed measles, receipt of live measles vaccine on or after the first birthday, or serologic evidence of immunity) due to an immunization requirement effect since 1986.” Tugwell et al. [19] “A chickenpox outbreak occurred in a school in which 97% of students without a prior history of chickenpox were vaccinated. Students vaccinated >5 years before the outbreak were at risk for breakthrough disease.” It would thus appear that these vaccines only provide waning immunity, not herd immunity, as already well established in the case of the mumps vaccine by Castilla et al. [16] This often has the effect of shifting a relatively mild childhood disease to older age groups of children or young adults, in whom complications and sequelae from the disease are much more severe [15]. 6) Promoted and elaborated a plan for introducing new vaccines of questionable efficacy and safety into the routine paediatric schedule, on the assumption that the licenses would eventually be granted. On 7th May1999 (http://www.dh.gov.uk/ab/JCVI/DH_095050), the JCVI met to discuss the use of the new conjugate Group C meningococcal vaccines. At the beginning of the meeting, Professor Hull, the Chairman: “...reminded members that the minutes and proceedings of the JCVI were confidential. Politically and clinically sensitive material was dealt with by the Committee...” It was further emphasised: (8. Meningococcal meningitis, i.) BSEM March 2011 The Health Hazards of Disease Prevention 30 “This was the main agenda item for the meeting. Much information had been made available and important decisions were required of the Committee, particularly about the introduction of meningococcal Group C conjugate vaccine, of which three brands would soon become available. Any decision would be dependent on the granting of product licenses and the wording of those licenses and, during the discussion, the Committee had to act on the assumption that licenses would be granted. The MCA was responsible for the safety, efficacy and quality of vaccines. The question for consideration by the Committee was how it would recommend that the vaccine should be introduced.” The Committee members were also once again: “...reminded that this issue, and the papers presented, was extremely sensitive, commercially and politically. It was requested that confidentiality be maintained.” The Chairman had then asked for any declarations of interest: “Professor Cartwright was involved in manufacturers’ studies on the vaccines, including health trials. Dr Goldblatt was involved in one company-sponsored study and had provided a clinical expert report to the MCA for one manufacturer. Dr Jones was involved in trials for two of the companies involved. Dr Schild said that NIBSC was evaluating the vaccines.” In spite of these substantial conflicts of interests: “There were no objections to these members continuing to take part in the meeting and it was agreed that they would be able to provide a valuable input to the discussion in common interest.” We are only left to speculate as to what such “common interest” might have been, between the JCVI and the pharmaceutical industry, bearing in mind several past instances where the Chairman of the JCVI met with the Association of British Pharmaceutical Industries to discuss: “...the availability of scarce vaccines and the introduction of new vaccines into more regular use. The question of financial support for training members of the health service in immunisation was also discussed.” (18. Meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries, JCVI meeting on 23rd October 1987; http:// www.dh.gov.uk/ab/DH_095169) or where: “The Chairman said that Departmental officials had recently met vaccine manufacturers who were keen to be informed, in confidence, of the outcome of JCVI discussions which might affect their own plans.” (2.iv. JCVI meeting on 4th May 1990 (http://www.dh.gov.uk/ ab/DH_095169) The apparent close ties between the pharmaceutical industry, JCVI and the DH perhaps explain why the DH funded studies were not adequately designed to detect long-term vaccine-related adverse outcomes. In discussing 8.4.1 Meningococcal C Conjugate (MCC) Vaccine Evaluation Programme, at the 7th May1999 JCVI meeting (http://www.dh.gov.uk/ ab/JCVI/DH_095050), Dr Elizabeth Miller reported: (i.) “Papers providing data on the new vaccines’ safety and efficacy and data from the Department of Health funded studies were looked at; no other country had conducted similar studies. The Medicines Control Agency had also gathered lots of information and NIBSC was evaluating the vaccines. The data provided to the Committee related to the Wyeth product, which would be the first to become available. All available ADR [adverse reactions] data was included; the follow-up of ADRs had been up to the end of 4 to 6 weeks.” It should be obvious that long-term adverse reactions cannot be identified if a study is not designed to detect them (and quite predictably there were none, since the DH funded BSEM March 2011 The Health Hazards of Disease Prevention 31 studies showed that the MCC vaccines were well tolerated, section 8.4.1. vii., 7th May1999 JCVI meeting; http://www.dh.gov.uk/ab/JCVI/DH_095050). The reason for such omissions in study design are bewildering, given the past safety issues with the measles vaccine, where several children “were left one year later with severe handicap.” (7. Suspected adverse reactions to measles vaccine: recent reports to the CSM, JCVI meeting on 17th of June 1983; http://www.dh.gov.uk/ab/JCVI/DH_120115) Not only did the safety of the new, soon-to-be introduced MCC vaccine remain questionable, but also: (ii.) “There was no good evidence for the efficacy of the meningococcal Group C conjugate vaccine, only the surrogate of antibodies compared with those known to be protective against invasive disease. To actually test the efficacy on the conjugate vaccine it would be necessary to introduce the vaccine and then conduct a Phase III or Phase IV study to test efficacy; this would be very difficult to do and would delay introduction by 3-5 years.” In the ensuing discussion we are told that the JCVI: (iii.) “...felt that it was important to plan the programme now and confirmation that the vaccines were equally effective could follow.” In other words, the JCVI and the DH were actively working on a plan to introduce a vaccine with no demonstrable safety or efficacy into a routine paediatric schedule. Apparently, those responsible for sound safe and effective immunisation policies concluded that it was “very difficult” to conduct the necessary trials and they felt that this would unnecessarily delay the introduction of the MCC vaccine into a routine immunisation schedule. What should have been considered by the JCVI is that vaccines represent a special category of drugs, generally given to healthy individuals and often to prevent a disease to which an individual may never be exposed [1]. Because of this, according to the US FDA, significant emphasis should be placed on vaccine safety [1]. Thus, If there are uncertain benefits from a vaccine, only a small level of risk of adverse effects may be acceptable. If the benefits are certain, then a greater risk of side effects may be tolerated. However, neither of these two points would have applied in the case of the MCC introduction programme, since there is absolutely no clinical benefit to a child from a vaccine that has neither been proven to be safe nor effective. The only “benefit” from such a programme would have been more in line with certain “common interests” rather than public health. What followed at the 7th May 1999 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), was a discussion on priority groups to whom the MCC vaccine should be offered, in which Dr Smithson made a following remark: (ix.) “...there was very little to chose between the priority age groups but suggested that infants were easier to target.” Finally, the Committee concluded that: (x.) “...if sufficient vaccine was available, all children should have it...” In the following meeting, held on 21st January 2000 (http://www.dh.gov.uk/ab/JCVI/ DH_095050), in section 6.4 Meningococcal C Conjugate (MCC) Vaccine Evaluation Programme, Dr Elizabeth Miller reported that several safety studies indicated that the new vaccine was not a cause for concern. Although, (6.4.4) BSEM March 2011 The Health Hazards of Disease Prevention 32 “... headache, particularly if it was associated with muscle stiffness inevitably raised fears of actual meningitis, although the vaccine could not cause this.” Furthermore: (6.4.6) “The Committee noted that this information would not have been available without the cooperation of the manufacturers. This had given everyone much more confidence in the vaccine programme and was a unique co-operation.” In the following meeting, on 9th October 2000 (http://www.dh.gov.uk/ab/JCVI/ DH_095050), the Committee was given an update on the safety profile of the MCC vaccine: (7.6.2) “The Working Party had received data available and had concluded that an association between MenC vaccine and seizures had not been proven. There had been 14 deaths reported. (2 further deaths had since been reported: 7 of the deaths were SIDS, 2 were meningitis B, 3 were in children with underlying conditions 1 was pneumococcal septicaemia, 1 was infantile encephalitis, 1 bronchiolitis and 1 child collapsed one month after immunisation with no cause of death being found).The Working Party believed that the deaths were all explained by other causes and that the vaccine was most unlikely to be implicated. By 21 September 2000, there had been 8.300 reports of 17,000 ADRs (1 ADR per 2,000 doses). The profiles were the same for each brand of vaccine.” Note that the Working Party “believed” that the vaccine was not implicated. An even firmer belief in MCC vaccine safety was held by the JCVI: (7.6.3) “The Committee did feel that the MCA statement that there was “no evidence that the vaccine caused meningitis” was far too light: the vaccine categorically did not cause meningitis. The MCA Meningitis Working Party would consider this issue further...” How the JCVI could claim with such definite certainty that the newly introduced and poorly tested MCC vaccine could not cause meningitis is not clear from the transcript. Amongst those who did not share similar views with regards to vaccine safety are Alexander Harris Injury and Accident Solicitors and their clients, families whose children appear to have suffered severe long-term health problems fol l owing MCC vaccination. From t h e i r websi t e (http:// www.alexanderharris.co.uk/OurWork/ProductLiability/MeningitisCVaccine/Pages/default.aspx), we learn that safety concerns about MCC vaccine were first raised by the media (and not the UK health authorities) and that: “Some 16,527 adverse reactions from 7,742 patients had been reported by GPs to the Medicines Control Agency through the Yellow Card reporting system. As well as reactions at the site of the injection such as swelling and soreness were other long-term reports which included seizures and 12 deaths.” This appears to be consistent with the data reported at the JCVI 9th October 2000 meeting. Further, the Solicitors made an important observation: “The Yellow card reporting system is not routinely used by most GPs and healthcare professionals and as such the figures for adverse reactions are likely to be an underestimate. Despite the known under-reporting, the number of adverse reactions reported for Meningitis C vaccine is the highest for any vaccine within the UK immunisation programme.” 7) BSEM March 2011 The Health Hazards of Disease Prevention 33 8) Actively discouraged research on vaccine safety issues. On 14th October 1985 a letter was issued to Dr Derek Zutshi (DHSS), from a member affiliated with the London School of Hygiene and Tropical Medicine at the University of London, whose name was erased from the copy of the letter prior its FOI release (http://www.dh.gov.uk/prod_consum_dh/ groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4140359.pdf): “Dear Derek Enclosed are comments on the estimates of vaccination-associated SIDS as presented at the recent ARVI meeting. I hope they prove helpful. Let me add that this is a complicated problem, but one that I would be interested to pursue in the future.” In three pages, the author of the letter made several comments on “Tabled Paper 1, (Appendix to ARVI/85/34)”, titled “Note on the estimation of sudden infant deaths expected to occur by chance after immunization”, authored by Paul EM Fine from the London School of Hygiene and Tropical Medicine. A balanced critical overview was given on three key points relevant to Paul EM Fine’s estimation of SIDS: “method used”, “data used” and “assumptions made”, outlining both strengths and limitations. In a final note, the author concluded: “These brief comments indicate a number of problems which arise in estimating the number of SIDS deaths expected to arise by chance, within 24 hours of vaccination, if there were no causal association between them. Some of these problems favour overestimation and others favour underestimation by the methods used in the DHSS note. Given the nature and direction of the biases, it is probable that the estimates presented in the DHSS note are of the correct order of magnitude. On the other hand, given the importance of the subject, a more thorough examination of the subject seems appropriate.” Copies of this letter appear to have been forwarded to Dr M Graveney (DHSS) and Professor RW Gilliatt (JCVI). Two months later, on 13th December 1985, on the University of Nottingham, Department of Child Health’s letterhead, a member whose name was erased from the copy of the letter released under FOI (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/ digitalasset/dh_4140362.pdf), also wrote to Dr Derek Zutshi, to express his grave concerns about potential further investigations into the relation between vaccination and SIDS: “Dear Derek I showed the Tabled Paper 1, (Appendix to ARVI/85/34) to Richard Madeley [Department of Community Medicine and Epidemiology, University of Nottingham Medical School] and he kindly prepared the enclosed observations. I agree with everything that he has said. As you know, at the meeting I had grave misgivings about the exercise and of the assumptions that were made.” In the following section, “Re: Note on the estimation of sudden infant deaths expected to occur by chance after immunisation”, apparently from the author of the “enclosed observations”, Richard Madeley, several reasons are given for his own misgivings “about the exercise”, some of which appear to be sound, such as: (3. The hypothesis that immunisation may cause SIDS) “c. Most deaths from SIDS occur before the age of four months2, when first immunisation takes place.” (note, this still does not exclude the possibility that some cases of SIDS may be vaccine-related) while others appear not as sound: “d. There is no foolproof method of discrediting the hypothesis by statistical or epidemiological methods. On the contrary, there is a danger of getting drawn into a lengthy BSEM March 2011 The Health Hazards of Disease Prevention 34 argument about numbers which neither side could win, thus giving more credibility to the hypothesis than it deserves.” (it ought to be noted that in the realm of science, a hypothesis can only be proven or disproven by experimental evidence and not by personal opinions) In his “Final Comments and Conclusions” the author stated: “For those reasons, I think it would be extremely unwise for the DHSS to get involved in any type of epidemiological work on this hypothesis. The hypothesis seems most unlikely on grounds of basic scientific reasoning, and such evidence as already exists points in the opposite direction.” “To go ahead in these circumstances would endow upon the hypothesis a respectability which it does not deserve. It is impossible to disprove through numbers. To try to do so, using flawed assumptions, as in the memorandum of the DHSS Statistics Division, weakens the position.” Indeed, epidemiological work would not be the most appropriate way to address the possibility that SIDS could be causally related to vaccination given that epidemiological studies only test for “association” and not “causation”. However, case control studies as well as post-mortem lab analysis should have been considered as viable alternatives to further research. Such as: Ottaviani et al. [20] “Herein we report the case of a 3-month-old female infant dying suddenly and unexpectedly shortly after being given a hexavalent vaccination. Examination of the brainstem on serial sections revealed bilateral hypoplasia of the arcuate nucleus. The cardiac conduction system presented persistent fetal dispersion and resorptive degeneration. This case offers a unique insight into the possible role of hexavalent vaccine in triggering a lethal outcome in a vulnerable baby. Any case of sudden unexpected death occurring perinatally and in infancy, especially soon after a vaccination, should always undergo a full necropsy study according to our guidelines.” “The identification of a possible pathological basis of reflexogenic mechanisms in sudden, unexpected infant death necessarily requires examination of the brainstem nuclei and of the cardiac conduction system on serial sections.” The senior author of this study, Professor Luigi Matturri is a member of the European Medicines Agency (EMEA) Pathologists Panel for evaluation of SUD (sudden unexpected death) cases reported for hexavalent vaccines. In a review by EMEA cited in the Introduction of the study, of five reports of unexplained deaths in children which occurred within 24 hours of vaccination with a hexavalent vaccine, panels of experts (including pathologists with the experience in the field of vaccines and SIDS), investigated whether there might have been a link between the vaccines and the deaths observed: “The EMEA’s conclusions were that the causes of death remained unexplained. SIDS, viral infection, metabolic disorders, allergic reactions or airway obstruction were plausible but were not definitely proven to have been the cause of death [4]. However, to the best of our knowledge, during the mentioned post-mortem investigations, little, if any, attention was paid to examination of the brainstem and the cardiacconduction systems on serial sections, nor was the possibility of a triggering role of the vaccine in the lethal outcome considered.” In addition, in responding to numerous criticisms of their study Unexplained cases of sudden infant death shortly after hexavalent vaccination [21] Zinka et al. noted [22]: “(ad 6) The main problem is that vaccination specialists have failed for decades to establish any tests or other criteria to find out if adverse events are linked to vaccinations or not. To our knowledge they did not even try hard—why?!” “(1) A precise description of the mechanism leading to serious adverse events after hexavalent vaccination is not the task of forensic pathology. This would be the job of vaccination specialists, and actually this job should have been done before phase 1 and phase 2 studies in order to get valid data on the drug safety.” BSEM March 2011 The Health Hazards of Disease Prevention 35 In summary, it may be inferred from here that the real reason why causality is rarely (if ever) established by scientific investigations into vaccine-related serious adverse outcomes is because it is assumed that: a) they don’t happen and b) the study is not designed to detect them. This may further suggest that vaccines are not proven to be safe but are only assumed to be safe. Indeed, according to the US FDA “Historically, the non-clinical safety assessment for preventive vaccines has often not included toxicity studies in animal models. This is because vaccines have not been viewed as inherently toxic” [1]. 9) Deliberately took advantage of parent’s trust and lack of relevant knowledge on vaccinations in order to promote a scientifically unsupported immunisation program which could put certain children at risk of severe long-term neurological damage. Recently the DH announced that there would be a significant change in the current UK immunisation schedule, following the October 2010 meeting at which the JCVI recommended that children be vaccinated against six diseases at the same time. This would be through receiving three vaccines (Hib/MenC, MMR and pneumococcal) in one visit rather than getting the first vaccine at 12 months of age and the second two at 13 months of age. According to a letter sent by the Chief Medical Officer Professor Dame Sally Davies to local GPs (http://www.dh.gov.uk/en/ Publicationsandstatistics/Lettersandcirculars/Professionalletters/Chiefmedicalofficerletters/ DH_121748), this new “simplified” immunisation policy is to be implemented "as soon as practicable". Furthermore, according to a BBC news report on 22nd November 2010 (http:// www.bbc.co.uk/news/health-11809967), the purpose for vaccinating against 6 diseases at one single appointment is “to boost vaccine uptake”, which has apparently been low ever since safety concerns regarding the MMR vaccine had been raised in public following the study of Wakefield et al. in 1998 [3]. Despite continued public concerns on the overall safety of the MMR and its possible link to autistic regression and other severe neurological outcomes, the DH spokesperson stated (http://www.dh.gov.uk/en/MediaCentre/Statements/DH_122026): “Independent scientific research has shown that providing these vaccines at the same time is safe, effective and more convenient for parents.” I have requested from the UK DH to show me these independent data. The request was granted, and much more than that. First to the independent data: they are not independent. The study by Miller et al. [23], referenced by the DH states in the acknowledgments: “This is an independent report funded by the Policy Research Programme in the Department of Health, UK, grant 039/031.” As for the safety assessment: “For safety, proportions of children with erythema, swelling or tenderness at site of injection, or fever or other systemic symptoms for 7 days after immunization were compared between regimens. No adverse consequences for either safety or immunogenicity were demonstrated when MCC/Hib was given concomitantly with PCV and MMR at 12 months of age or separately at 12 and 13 months of age.” Thus the vaccine was “demonstrated safe” based on a 7 day follow-up and monitoring for largely local reactions. Not only is this an appalling example of a vaccine safety study, it is the only study quoted by the DH and JCVI in support of their decision to implement a new vaccine schedule. This is evident from a Possible simplification of the childhood vaccination schedule report (http:// www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/ dh_121799.pdf), issued by the JCVI Secretariat in October 2010, which states: (4.) BSEM March 2011 The Health Hazards of Disease Prevention 36 “In June 2009, JCVI considered a pre-publication clinical trial paper from Miller et. al. that showed that co-administration did not adversely affect the immune response elicited by the vaccines. In addition, no safety concerns around co-administration were identified.” The JCVI report further states: (Annex A, Background) “In June 2009 the Joint Committee on Vaccination and Immunisation concluded that there is no scientific reason to keep the combined Hib and Meningitis C vaccine (currently given at 12 months) and the MMR and pneumococcal vaccines (given at 13 months) separate.” The “no scientific reason” is grossly misleading. Once again, it should be obvious that safety concerns cannot be identified if the study is not designed to detect them. Autistic regression is known to occur gradually over periods of weeks to many months. In spite of this, the vast majority of studies which are presumed to provide conclusive evidence on the safety of vaccines, have short follow ups and focus almost exclusively upon acute near-immediate events [23-29]. In addition, the fact that in 2008 The US federal Advisory Committee on Immunization Practices (ACIP) voted to withdraw their initial recommendation for the use of measles, mumps, rubella, and varicella vaccine (MMRV, marketed by Merck & Co., Inc. as ProQuad) as the vaccine of choice for vaccination of infants, because it was associated with double the risk of febrile seizures when compared to the MMR, shows that there is indeed solid reason for concern over simultaneous administration of multiple vaccines. Proquad contains only four vaccines in combination, not six. The research from The Vaccine Safety Datalink (VSD), considered by the ACIP, evaluated the incidence of febrile seizures in 43,000 children between the ages of 12 and 23 months who had been vaccinated with ProQuad and 315,000 who had received two separate MMR and varicella vaccines. Within 7 to 10 days after vaccination, those given ProQuad suffered twice as many seizures (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5710a3.htm): “The preliminary results indicated a rate of febrile seizure of nine per 10,000 vaccinations among MMRV vaccine recipients compared with four per 10,000 vaccinations among MMR vaccine and varicella vaccine recipients.” The multivalent vaccine Hexavac was also recently withdrawn following a recommendation from the EMEA (http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/12/ WC500017695.pdf) “as a precautionary measure“, due to its poor effectiveness. Safety concerns have also been raised over administration of hexavalent vaccines by Ottaviani et al. [20] and Zinka et al. [21] the latter, following five cases of infant deaths in Germany in 2005 (all occurring within 48 hrs of vaccination). The post-mortem analysis of six children aged 4-17 months (5 of whom were vaccinated with Hexavac and one with another hexavalent vaccine, Infanrix Hexa) reported by Zinka et al. [21], revealed abnormal pathologic findings particularly affecting the nervous system. Although there is no conclusive proof that these deaths were directly caused by vaccination, the authors felt it was: “...important to inform vaccinating physicians and pediatricians as well as parents about such possibly fatal complications after application of hexavalent vaccines.” In spite of these relevant findings, no mention of these two studies is found in the DH and the JCVI reports regarding the introduction of the new “simplified” and “improved” schedule. Other than the paper by Miller et al. [23], the DH also provided me with the official report on their research on parents’ attitudes to the possibility of administering the Hib/MenC, PCV and MMR vaccines on a single occasion. Following their initial consideration of the draft paper by Miller et al., in 2009, the JCVI did recognize the need to seek parent’s opinion on the proposed “6 in 1” program before making any changes to the current schedule. In February 2010, the DH initiated this research and subsequently published it in a document Childhood immunisation programme: Attitudinal research into combining 12 and 13 month immunisations which is now available on the DH website at: http://www.dh.gov.uk/en/Publichealth/Immunisation/Marketresearch/index.htm BSEM March 2011 The Health Hazards of Disease Prevention 37 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/ digitalasset/dh_122329.pdf What the Attitudinal research found was that parent's knowledge on childhood's current immunisation timetable, particularly around 12 and 13 months, was generally low and apparently, the DH and the JCVI are content with keeping it that way, in order to preserve the national vaccination program. The DH and the JCVI concluded that informing parents of the changes would be “unwise” because it would create unnecessary panic. In order to prevent this, the health officials need to be instructed on how to “reassure” parents in the safety of vaccines, especially the MMR. According to the Attitudinal research report, parents generally trusted the schedule and the NHS, however, some had reservations about the MMR, particularly if it was to be combined with other vaccines. Specifically, the Research Management Summary on Behalf of the DH from a Possible simplification of the childhood vaccination schedule report (http://www.dh.gov.uk/ prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_121799.pdf), issued by the JCVI Secretariat, states that: “While the principle of combining vaccinations and/or giving more than one at the same time appeared largely to be accepted, if one of these is MMR, views can change.” (Conclusions and Recommendations: 2.) In light of this explicit concern, the DH report noted: “The combined schedule at 12 and 13 months was regarded with mixed feelings; if it is introduced, the way in which it is communicated will have a significant impact on how it is received. Given low awareness of the immunisation schedule, parents are unlikely to notice the change until informed about it.” [their emphasis added-italicised] (Conclusions and Recommendations: 3.) They further elaborated on this particular finding: “When the combined schedule was presented to parents first (before seeing the current schedule), very few identified the appointment at a year of age as different or worthy of comment. Parents’ problems and worries only came to the surface when the combined option was explicitly presented as a change to the schedule. Those in areas where the combined schedule is apparently already being given accepted it without question. When parents were told that the new schedule involves giving MMR and PCV at the same time as another vaccine, some changed their views, including some of those who were otherwise accepting of MMR.” (Conclusions and Recommendations: 4.) On the basis of the above observations the DH concluded that it is best to keep parents ignorant of the proposed changes, in order to avoid what they deemed as “unwarranted anxiety”, as this would most likely lead to reduced immunisation rates: “Offering parents a choice between the two schedules could generate more questions than answers, and seems unwise. It might also risk compromising current understanding of the vaccination schedule as ‘just what happens’, and reframing it as optional, which could reduce vaccine uptake.” (Conclusions and Recommendations: 5.) Consistent with their past legacy that apparently puts priority on the preservation of the vaccination program rather than the safety of an individual, the British Health Authorities consider it “unwise” that parents should have a choice as to how immunisations are to be carried out. So much so that special action is needed to assure that their efforts in promoting vaccination are not hampered. In particular, to the DH it “seems sensible” to, somehow, camouflage the change in the vaccination schedule in order to prevent what they deem as “unwarranted anxiety”. “It is also clear that offering parents detailed information, and flagging up changes, can generate anxiety where it is not warranted. In light of this, it seems sensible to introduce the combined schedule as far as possible without announcing it explicitly as a change.” (Conclusions and Recommendations: 6.) BSEM March 2011 The Health Hazards of Disease Prevention 38 Indeed, the DH offers an elaborate strategy for addressing parental concerns about the “improved” and “simplified” vaccination program: “If the combined immunisation is introduced, some parents will have questions about it, and health professionals, especially health visitors and practice nurses, will be their first port of call for information. Health professionals will have an important part to play in informing and reassuring parents, and they will need to provide consistent answers; any variation between what they say is likely to create a sense of unease among parents.” (Conclusions and Recommendations: 7.) In revealing further details on how the health staff should approach those parents who may have concerns over the safety of the MMR vaccine, the DH advises: “Health professionals will need to be ready to reassure parents that… • combining vaccinations into one appointment and giving three at a time is entirely safe • the fact that MMR is one of these makes no difference, because MMR is safe • there is a good reason for the change: though the current system is effective and safe, changing it will be an improvement • there are significant benefits to baby and parent in having one fewer appointment and reduced distress” It should be obvious that any a priori exclusion of possible adverse effects from vaccines which is not based on valid scientific evidence but rather, a belief system is not by definition scientific. Rather, it reflects a disturbing trend to view anything associated with vaccines and vaccine policy as sacred and beyond scientific scrutiny. The need to protect the UK government-mandated vaccination program against any reasonable doubt, in the absence of any truly independent scientific evidence and despite a) CSM/JCVI/ARVI’s own records discussed under Sections 1)-3) & 5) which show that vaccines, including measles and the MMR are not “entirely safe” and b) the government’s own concession that the MMR can in fact cause permanent brain damage (in the case of Robert Fletcher who in August 2010 received £90,000 payout for epilepsy and severe mental retardation that he suffered following the MMR jab; http://www.bbc.co.uk/news/uk-englandmerseyside- 11125343), is even more disturbing. If vaccines are indeed entirely safe as the DH and the JCVI claim, why do they feel they need to hide information from parents and health professionals? Perhaps “combining vaccinations into one appointment and giving three at a time is” not “entirely safe” As a reminder (JCVI meeting, 11th December 1974; http://www.dh.gov.uk/ab/JCVI/DH_095052): (11 Simultaneous administration of live vaccines (CHCS(VI)14)) “Professor Dick and Dr Warin pointed out that an interval in the administration of live vaccines had been advocated in view of the probability of adverse reactions and because of the recent publicity surrounding adverse reactions. The Committee agreed that it would be inopportune to change the guidance that an interval of at least 3 weeks should be allowed to elapse between the administration of any 2 live vaccines whichever came first.” The above would explain the need to censor certain information as well as why the JCVI went to great lengths in devising a special strategy with which such a task would be achieved: “Given continued sensitivity about MMR, any negative news coverage will have a significant impact. Health professionals will be the front line in combating this, and will need to be kept fully informed on the latest information from JCVI and DH to prevent any contradictions or confusion, and to ensure that they are equipped to reassure parents.” (Conclusions and Recommendations: 9.) BSEM March 2011 The Health Hazards of Disease Prevention 39 The choice of words is rather peculiar here, it appears as if the DH and the JCVI are preparing for war. Their choice of weapons includes “educating” health professionals with what appears to be highly censored information, since numerous truly independent studies which raised safety concerns in the scientific community (particularly about the MMR vaccine), were simply dismissed by the JCVI (see Section 4). Both the JCVI and the DH opted instead for the methodologically dubious study by Miller et al. [23] as their only evidence to promote the new “improved” and “simplified” immunisation program. This obvious information bias is to be promulgated by the JCVI/ DH to the health profession. Furthermore, according to the DH, it is not only important to censor information given to both parents and health professionals, the way in which this information is to be communicated is also very important. “It is important that the information given by health professionals is pitched at the right level. The JCVI information prompted questions among many respondents, but was useful for reassuring some, particularly those with a more pragmatic view of immunisation. Information at this level needs to be carefully tailored by health professionals according to the attitudes of individual parents.” The corresponding section from the Attitudinal research report (http://www.dh.gov.uk/ prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_122329.pdf) adds: “If in doubt, we would suggest keeping it simple, as outlined above.” (D Conclusions; 3. Dealing with questions about the change to a combined schedule) Since some disclosure to the parents on adverse events associated with the combined schedule is necessary, it is further regarded that in spite of some: “...diverging views on when the sheet should be given to parents; on balance it seems wise to hand it out immediately before vaccination, so that parents feel they have been given advance warning, but do not dwell on the content to the extent that they begin to worry.” (D Conclusions; 4. The tear-off sheet on side effects) The idea of “keeping it simple” was also welcomed by the health professionals. Indeed, as already discussed in Section 5), the public may not understand correctly the significance of febrile convulsions. Nor would anyone want the public to dwell extensively on associations between the words “vaccine” and “death” or “permanent brain damage”. One has to wonder whether parents who to this day continue to trust the British Health Authorities on matters of immunisation, would still have the same opinion if crucial facts on vaccine-associated adverse events discussed in “commercial” and “in confidence” CSM/JCVI/Joint Sub-Committee ARVI meetings were fully disclosed to them: From the Attitudinal research report (pg 22): “To my eyes these things have all been tried and tested, the medical people studied for years, they tried all of this stuff. They obviously know getting these things correctly so my trust is in their hands really at the end of the day.” From a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis vaccine, 7th February 1986, CSM/JCVI/Joint Sub-Committee ARVI ( h t t p : / / w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t i o n / Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306): (6.5.1) “It was considered unreasonable to ask paediatricians to report for a period of six years.” “No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.” From Miller et al. [23] BSEM March 2011 The Health Hazards of Disease Prevention 40 “For safety, proportions of children with erythema, swelling or tenderness at site of injection, or fever or other systemic symptoms for 7 days after immunization were compared between regimens.” From the JCVI meeting held on 3rd November 1981 (http://www.dh.gov.uk/ab/DH_095169): (5.d. Comments on Professor Stewart’s letter) “Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event...The Chairman concluded that much was not known about the natural history of brain damage in the young.” From the Attitudinal research report (pg 22): “...the diseases must be serious and pose a risk – ‘the NHS wouldn’t put children through it [so young] if it wasn’t necessary.” From the JCVI meeting on 11th December 1974 (http://www.dh.gov.uk/ab/JCVI/DH_095052): (10.) “...mumps vaccine was unnecessary because complications from the disease were rare. The Committee agreed that there was no need to introduce routine vaccination against mumps.” From a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis vaccine, 7th February 1986, CSM/JCVI/Joint Sub-Committee ARVI ( h t t p : / / w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t i o n / Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306): (6.5.1) “No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.” From the Attitudinal research report (pg 23): “They’re in the book and they say you should do them, I think if I don’t do them then that’s wrong. They know what they’re doing.” From the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting, held on 5th October 1984 (http://www.dh.gov.uk/ab/JCVI/DH_095294): (9.) “Fetal damage after accidental polio vaccination of an immune mother. Barton AE et al. Journal of the RCGP 1984: 34: p. 390-394 Dr Smith observed that the termination of the pregnancy at 20 weeks in this case report was not related to the administration of oral poliovaccine (OPV).” Note: how such conclusion could be reached remains unclear since: “However, the foetus was reported to have signs of infection with poliovirus in the nervous system although no similar event had been previously seen after vaccination.” From the Attitudinal research report (pg 23): “I don’t think they would put something into a child that is not good for them.” BSEM March 2011 The Health Hazards of Disease Prevention 41 “I put my hands in the medical profession and they do a good enough job for me and I trust them.” “Surely they wouldn’t give these injections if they felt they would harm?” “I do think it’s a good thing. You want to try and protect your children so if that’s what they’re suggesting they have to have done you should trust your health professionals.” “Because they’re recommended you kind of trust the doctors to guide you.” From the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting, held on 6t h July 1987 (http://www. d h . gov.uk/en/FreedomOf I n formation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306): (6.1 Whooping cough) “He explained that in February the CSM had called for ARVI’s advice about updating the statement made in the 1981 report on Whooping Cough (HMSO) about a possible link between DTP immunisation and serious neurological illness. It had been hoped that by this means ‘discovery’ of all the relevant JCVI, CSM and ARVI documentation on whooping cough vaccine could be avoided.” From the JCVI/Joint Sub-Committee ARVI “commercial in confidence” meeting on 6th February 1987, section “7.1 Whooping cough vaccine –CSM advice” (contents of the statement that CSM wished to mod i f y ; http://www.dh.gov.uk/en/FreedomOf I n formation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306): “No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist. We would also agree that the evidence suggests that the vaccine causes convulsions in some children.” From the CSM/JCVI/Joint Sub-Committee ARVI “commercial in confidence meeting on 3rd October 1 9 8 6 ( h t t p : / / w w w. d h . g o v. u k / e n / F r e e d o m O f I n f o r m a t i o n / Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306): (5.1.3.c.) “From the above there is reason to believe that the increased relative risk of prolonged convulsions after DTP was a real one.” From the JCVI meeting on 3rd November 1989 (http://www.dh.gov.uk/ab/DH_095169): (9. ARVI Committee – Minutes of meeting 6 October 1989 (JCVI (89)25) “Dr Schild reported that NIBSC was now able to distinguish clearly the wild strains from each of the two vaccines, and isolates from CSF clearly showed Urabe in all three cases believed to be associated with vaccine-although it should not be assumed that Jeryl-Lynn is not capable of the same result.” From the JCVI meeting on 7th May 1999 (http://www.dh.gov.uk/ab/JCVI/DH_095050): (8. Meningococcal meningitis, i.) “Committee members were reminded that this issue, and the papers presented, was extremely sensitive, commercially and politically. It was requested that confidentiality be maintained. The Chairman asked for any declarations of interest. Professor Cartwright was involved in manufacturers’ studies on the vaccines, including health trials. Dr Goldblatt was BSEM March 2011 The Health Hazards of Disease Prevention 42 involved in one company-sponsored study and had provided a clinical expert report to the MCA for one manufacturer. Dr Jones was involved in trials for two of the companies involved. Dr Schild said that NIBSC was evaluating the vaccines. “There were no objections to these members continuing to take part in the meeting and it was agreed that they would be able to provide a valuable input to the discussion in common interest.” From a discussion of the 8.4.1 Meningococcal C Conjugate (MCC) Vaccine Evaluation Programme, at the 7th May1999 JCVI meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050): (ii.) “There was no good evidence for the efficacy of the meningococcal Group C conjugate vaccine, only the surrogate of antibodies compared with those known to be protective against invasive disease. To actually test the efficacy on the conjugate vaccine it would be necessary to introduce the vaccine and then conduct a Phase III or Phase IV study to test efficacy; this would be very difficult to do and would delay introduction by 3-5 years.” (iii.) “It was felt that it was important to plan the programme now and confirmation that the vaccines were equally effective could follow.” Standards of Conduct Finally, a reader may wish to assess the presented data on JCVI vaccination policies against the JCVI’s own Code of Practice (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/ @dh/@ab/documents/digitalasset/dh_115363.pdf) which states: (Responsibilities of Committee and Sub-committee members): (30)“All members of the Committee and its Sub-committees (‘members’) must demonstrate high standards of conduct.” (31)“In exercising their duties, members must observe the ‘Seven Principles of Public Life’ set out by the Committee on Standards in Public Life (the Nolan Committee): Selflessness: Holders of public office should take decisions solely in terms of the public interest. They should not do so in order to gain financial or other material benefits for themselves, their family, or their friends Integrity: Holders of public office should not place themselves under any financial or other obligation to outside individuals or organisations that might influence them in the performance of their official duties. Objectivity: In carrying out public business, including making public appointments, awarding contracts, or recommending individuals for rewards and benefits, holders of public office should make choices on merit. Accountability: Holders of public office are accountable for their decisions and actions to the public and must submit themselves to whatever scrutiny is appropriate to their office. Openness: Holders of public office should be as open as possible about all the decisions and actions that they take. They should give reasons for their decisions and restrict information only when the wider public interest clearly demands. BSEM March 2011 The Health Hazards of Disease Prevention 43 Honesty: Holders of public office have a duty to declare any private interests relating to their public duties and to take steps to resolve any conflicts arising in a way that protects the public interest. Leadership: Holders of public office should promote and support these principles by leadership and example.” (Conflicts of Interests) (39) Personal pecuniary8 interest “If a member has in the last 12 months received, or plans to receive a financial payment or other benefit from a business or representative body relating to vaccines or any other product or service that could be under consideration by JCVI or a Sub-committee including: • holding a directorship, or other paid position • carrying out consultancy or fee paid work • having shareholdings or other beneficial interests • receiving expenses (e.g. travel to, or registration for, conferences) and hospitality the member must declare this interest. If this interest is specific to an agenda item and the payment or other benefit is connected specifically with the product under consideration, the member will be required to absent him/herself from the discussion and any subsequent vote.” Summary In conclusion, by apparently prioritizing vaccination policy over vaccine safety, the JCVI, the DH and the Committee on Safety of Medicines (CSM) may have shown a disregard for the safety of children. Through selective data reporting, the JCVI in conjunction with the DH, has promulgated information relating to vaccine safety that may be inaccurate and potentially misleading, thereby making it impossible for the parents to make a fully informed consent regarding vaccination. Furthermore, by 1) apparently misleading patients about the true risks of adverse reactions as to gain their consent for the administration of the treatment and 2) seemingly siding with vaccine manufacturers rather than public health interests, the JCVI and the CSM appear to have signally failed their fiduciary duty to protect individuals from vaccines of questionable safety. If these provisional conclusions are indeed correct, then the information presented here may help us in understanding the UK government’s and the JCVI’s official position on vaccine damage, that is, one of persistent denial. BSEM March 2011 The Health Hazards of Disease Prevention 44 References [1] Food and Drug Administration (FDA). Workshop on Non-clinical Safety Evaluation of Preventative Vaccines: Recent Advances and Regulatory Considerations. 2002. http://www.fda.gov/downloads/ biologicsbloodvaccines/newsevents/workshopsmeetingsconferences/transcriptsminutes/ ucm054459.pdf, last accessed May 30 2011. [2] World Medical Association (WMA). WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 2011. http://www.wma.net/en/30publications/10policies/b3/, last accessed June 4 2011. [3] Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351 (9103): 637-41. [4] Sugiura A, Yamada A. Aseptic meningitis as a complication of mumps vaccination. Pediatr Infect Dis J 1991; 10(3): 209-13. [5] Fombonne E, Chakrabarti S. No evidence for a new variant of measles-mumps-rubella-induced autism. Pediatrics 2001; 108(4): E58. [6] Singh VK, Jensen RL. Elevated levels of measles antibodies in children with autism. Pediatr Neurol 2003; 28(4): 292-4. [7] Godlee F, Smith J, Marcovitch H. Wakefield's article linking MMR vaccine and autism was fraudulent. BMJ 2011; 342: c7452. [8] Balzola F, Barbon V, Repici A, Rizzetto M, Clauser D, Gandione M, et al. Panenteric IBD-like disease in a patient with regressive autism shown for the first time by the wireless capsule enteroscopy: another piece in the jigsaw of this gut-brain syndrome? Am J Gastroenterol 2005; 100(4): 979-81. [9] Balzola F., et al. Beneficial behavioural effects of IBD therapy and gluten/casein-free diet in an Italian cohort of patients with autistic enterocolitis followed over one year. Gastroenterology 2006; 130 (Suppl. 2): S1364 A-21. [10] Balzola F., et al. Autistic enterocolitis: confirmation of a new inflammatory bowel disease in an Italian cohort of patients. Gastroenterology 2005; 128 (suppl.2): A-303. [11] Chen B, Girgis S, El-Matary W. Childhood autism and eosinophilic colitis. Digestion 2010; 81(2): 127-9. [12] Krigsman A, Boris M, Goldblatt A, Stott C. Clinical Presentation and Histologic Findings at Ileocolonoscopy in Children with Autistic Spectrum Disorder and Chronic Gastrointestinal Symptoms. Autism Insights 2010; 2: 1-11. [13] Quigley EM, Hurley D. Autism and the gastrointestinal tract. Am J Gastroenterol 2000; 95(9): 2154-6. [14] Shoenfeld Y, Agmon-Levin N. 'ASIA' - Autoimmune/inflammatory syndrome induced by adjuvants. J Autoimmun. 2011; 36(1): 4-8. [15] Ternavasio-de la Vega HG, Boronat M, Ojeda A, Garcia-Delgado Y, Angel-Moreno A, Carranza-Rodriguez C, et al. Mumps orchitis in the post-vaccine era (1967-2009): a single-center series of 67 patients and review of clinical outcome and trends. Medicine (Baltimore) 2010; 89(2): 96-116. [16] Castilla J, Garcia Cenoz M, Arriazu M, Fernandez-Alonso M, Martinez-Artola V, Etxeberria J, et al. Effectiveness of Jeryl Lynn-containing vaccine in Spanish children. Vaccine 2009; 27(15): 2089-93. [17] Gustafson TL, Lievens AW, Brunell PA, Moellenberg RG, Buttery CM, Sehulster LM. Measles outbreak in a fully immunized secondary-school population. N Engl J Med 1987; 316(13): 771-4. [18] Hersh BS, Markowitz LE, Hoffman RE, Hoff DR, Doran MJ, Fleishman JC, et al. A Measles Outbreak at a College with a Prematriculation Immunization Requirement. American Joumal of Public Health 1991; 81 (3): 360-4. [19] Tugwell BD, Lee LE, Gillette H, Lorber EM, Hedberg K, Cieslak PR. Chickenpox outbreak in a highly vaccinated school population. Pediatrics 2004; 113(3 Pt 1): 455-9. [20] Ottaviani G, Lavezzi AM, Matturri L. Sudden infant death syndrome (SIDS) shortly after hexavalent vaccination: another pathology in suspected SIDS? Virchows Arch 2006; 448(1): 100-4. [21] Zinka B, Rauch E, Buettner A, Rueff F, Penning R. Unexplained cases of sudden infant death shortly after hexavalent vaccination. Vaccine 2006; 24(31-32): 5779-80. BSEM March 2011 The Health Hazards of Disease Prevention 45 [22] Zinka B, Penning R. Unexplained cases of sudden infant death shortly after hexavalent vaccination. Letter to Editor. Response to the comment by H.J. Schmitt et al. Vaccine 2006; 24: 5785–6. [23] Miller E, Andrews N, Waight P, Findlow H, Ashton L, England A, et al. Safety and immunogenicity of coadministering a combined meningococcal serogroup C and Haemophilus influenzae type b conjugate vaccine with 7-valent pneumococcal conjugate vaccine and measles, mumps and rubella vaccine at 12 months of age. Clin Vaccine Immunol 2011; 18(3): 367–72. [24] Kaplan SL, Lauer BA, Ward MA, Wiedermann BL, Boyer KM, Dukes CM, et al. Immunogenicity and safety of Haemophilus influenzae type b-tetanus protein conjugate vaccine alone or mixed with diphtheriatetanus- pertussis vaccine in infants. J Pediatr 1994; 124(2): 323-7. [25] Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, et al. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine 2011; 29(8): 1569-75. [26] Li G, Zhang H, Zhou W, Ye Q, Li F, Wang H, et al. Safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus influenzae Type b combination vaccine compared with separate administration of licensed equivalent vaccines in Chinese infants and toddlers for primary and booster immunization. Vaccine 2010; 28(25): 4215-23. [27] Marchant CD, Miller JM, Marshall GS, Blatter M, Aris E, Friedland LR, et al. Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J 2009; 29(1): 48-52. [28] Kanra G, Viviani S, Yurdakok K, Ozmert E, Yalcin S, Baldini A, et al. Safety, tolerability and immunogenicity of a Haemophilus influenzae type b vaccine containing aluminum phosphate adjuvant administered at 2, 3 and 4 months of age. Turk J Pediatr 1999; 41(4): 421-7. [29] Kim KH, Lee H, Chung EH, Kang JH, Kim JH, Kim JS, et al. Immunogenicity and safety of two different Haemophilus influenzae type b conjugate vaccines in Korean infants. J Korean Med Sci 2008; 23(6): 929-36. BSEM March 2011 The Health Hazards of Disease Prevention