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Microsoft word - open letter to paul keim nsabb 30 jan 2012

Elizabeth Hart
An open letter to the NSABB re the political and
ethical implications of lethal virus development
For the attention of:
Paul Keim, Acting Chair, National Science Advisory Board for Biosecurity
Please note this letter and your response will be forwarded to other parties for information. Michael Osterholm, NSABBRon Fouchier, Erasmus MCAb Osterhaus, Erasmus MCYoshihiro Kawaoka, University of Wisconsin-MadisonPeter Palese, Mount Sinai School of MedicineTom Jefferson, Cochrane Vaccines FieldPhilip Campbell, NatureCaroline Ash, ScienceDeborah Cohen, British Medical Journal Further to our previous correspondence on the controversial topic of ‘lethal flu virus’ development.
Please accept this open letter as a layperson’s perspective on this topic.
Ron Fouchier and Ab Osterhaus “whether it is appropriate to have one country,i.e. the United States, dominate a discussion that has an impact on scientists and public healthofficials worldwide”.
I am astonished at the naiveté of these scientists. Surely it must be obvious by now that bysponsoring development of a potentially lethal flu virus the United States could be in breach of thewhich entered into force in March 1975, i.e.
Each State Party to this Convention undertakes never in any circumstances todevelop, produce, stockpile or otherwise acquire or retain: (1) Microbial or other biological agents, or toxins whatever their origin or methodof production, of types and in quantities that have no justification for prophylactic,protective or other peaceful purposes; 1 Preventing pandemics: The fight over flu. Nature (2012). Published online 15 January 2012:http://www.nature.com/nature/journal/vaop/ncurrent/full/481257a.html2 Biological Weapons Convention (BWC). Convention on the Prohibition of the Development, Production and Stockpilingof Bacteriological (Biological) and Toxin Weapons and On Their Destruction. Entered into force March 26, 1975:http://www.armscontrol.org/treaties/bwc An open letter to the NSABB re the political and ethical implications of lethal virus development
________________________________________________________________________ Can it be argued that development of a lethal flu virus is justified for “prophylactic, protective or
other peaceful purposes”? I suggest this is highly questionable. For instance Thomas V.
Inglesby, Anita Cicero, and D.A. Henderson say: “We are not opposed to research in high-
containment labs using dangerous pathogens, including H5N1. Over the past decade, the Center
for Biosecurity has publicly argued for the importance of such research to develop diagnostics,
medicines, and vaccines for the most threatening infectious diseases.
But research and
development for those purposes to make them
more transmissible between humans.

In to the review summit on biological weapons in Geneva in December last year, saying thatSecretary Clinton warned of al Qaeda’s call to arms for “brothers with degrees in microbiology orchemistry to develop a weapon of mass destruction”.
It is interesting that Secretary Clinton deflected concern about the development of biological
weapons onto al Qaeda, while it is actually the U.S. that is actively involved in sponsoring
the development of lethal flu viruses
. I wonder if this irony was lost on other signatoriesthe
Biological Weapons Convention, such as Iran and Pakistan?
What position would the U.S. take if countries such as Iran and Pakistan sponsored lethal virusdevelopment? Dr Fouchier has announced his team “mutated the hell out of H5N1”, and warned that “this is avery dangerous virus”.
His claims must be subjected to scrutiny.
whether the flu virus developed in the Erasmus MC laboratory is indeed as deadly to humans aswe’ve been led to believe. (See for example a paper by Peter Palese and Taia Wang: H5N1influenza viruses: .
Regardless of whether the Erasmus MC developed virus is lethal to humans or not, the question
remains whether it is legitimate for any party to sponsor the development of lethal
viruses?

Perhaps if the controversial flu virus research studies conducted by Erasmus MC and theUniversity of Wisconsin-Madison had undergone an effective ethics approval process we wouldnot be in the unfortunate position we are in now? In his discussion of bioethicist MichaelSelgelid describes the conflict between the voluntary self-governance of the scientific community,and the security concerns of bureaucrats and security experts. Selgelid notes that “most of thedebates about the dual-use dilemma have primarily involved science and security experts ratherthan ethicists”. Selgelid argues that “biological weapons development may turn out to be one ofthe most serious consequences of the genetics revolution in biology”. He concludes: “It is thuscrucially important that there is more ethical input into debates about the governance of dual-useresearch.” Selgelid’s paper was published in 2009. Given the current controversy, it appears hiswarning fell upon deaf ears.
3 Editorial by Thomas V. Inglesby, Anita Cicero, and D.A. Henderson. The Risk of Engineering a Highly TransmissibleH5N1 Virus. Center for Biosecurity of UPMC. 15/12/2011: http://www.upmc-biosecurity.org/website/resources/publications/2011/2011-12-15-editorial-engineering-H5N1 4 Laurie Garrett. Flu Season. Foreign Policy. January 5, 2012:http://www.foreignpolicy.com/articles/2012/01/05/flu_season5 Biological Weapons Convention Signatories and States-Parties: http://www.armscontrol.org/factsheets/bwcsig 6 Katherine Harmon. What Really Happened in Malta This September When Contagious Bird Flu Was First Announced.
Scientific American. December 30 2011: http://blogs.scientificamerican.com/observations/2011/12/30/what-really-happened-in-malta-this-september-when-contagious-bird-flu-was-first-announced/ 7 Peter Palese and Taia T. Wang. H5N1 influenza viruses: Facts, not fear. Proceedings of the National Academy ofSciences of the United States of America. Published online before print January 25, 2012:http://www.pnas.org/content/early/2012/01/24/1121297109.full.pdf+html 8 Michael J Selgelid. Governance of dual-use research: an ethical dilemma. Bull World Health Organ 2009;87:720-723:http://www.who.int/bulletin/volumes/87/9/08-051383.pdf An open letter to the NSABB re the political and ethical implications of lethal virus development
________________________________________________________________________ A recent article in the reports that a “small – in relative terms – group oftechnical experts will be invited to Geneva in mid-February to begin the difficult task of trying tobreak an impasse arising from the proposed publication of controversial bird flu research…Participants will include representatives of the Dutch and American research teams thatconducted the studies, experts from WHO’s network of influenza laboratories and people withfirst-hand involvement in the dispute.” The Canadian Press article quotes Dr Keiji Fukuda, the WHO’s assistant director-general forhealth security and environment, who says: “We are not setting this up as a political meeting.
We are setting this up as a meeting of extremely knowledgeable technical people.” Government sponsored lethal virus development is an important political and ethical issue for the
world’s citizens.
I for one am not comforted by this proposed meeting being confined to “extremely knowledgeable technical people” with possible conflicts of interest. In this regard, Irefer you to the following articles (please see full reference details in the footnotes): I also suggest a press release published by the industry-funded European Scientific Working
Group on Influenza (ESWI), titled from both a scientific and ethical point of view(26 October 2011), should be subjected to
critical analysis. Ab Osterhaus, the ESWI chairman, is a contact on this press release.
This brazen attempt to stifle any questioning of flu vaccination is shocking, and must be
considered along with other material which does question the benefits of influenza vaccines, such
as the Cochrane Reviews and
9 Meeting to address bird flu research impasse: WHO. The Canadian Press. Saturday Jan. 21, 2012:http://www.ctv.ca/CTVNews/Health/20120121/who-bird-flu-research-meeting-120121/10 The handling of the H1N1 pandemic: more transparency needed. Parliamentary Assembly Assemblee parlementaire.
Report: Social Health and Family Affairs Committee. Rapporteur: Mr Paul Flynn, United Kingdom, SOC:http://assembly.coe.int/CommitteeDocs/2010/20100604_H1n1pandemic_E.pdf11 Deborah Cohen and Phillip Carter. WHO and the pandemic flu “conspiracies”. British Medical Journal. 12 June 2010.
Volume 340, 1274-1279: http://www.bmj.com/content/340/bmj.c3257?tab=full12 WHO and the pandemic flu “conspiracies” – Recent Rapid Responses. BMJ 2010;340:c2912:http://www.bmj.com/content/340/bmj.c2912?tab=responses 13 Declan Butler. Flu experts rebut conflict claims. Nature. Published online 8 June 2010 | Nature 465, 672-673 (2010):http://www.nature.com/news/2010/100608/full/465672a.html14 WHO failing in duty of transparency. Leading Edge. The Lancet. Vol 10, August 2010, 505:http://download.thelancet.com/pdfs/journals/laninf/PIIS147330991070147X.pdf15 Philip Bethge et al. The Swine Flu Panic of 2009. Spiegel Online 03/12/2010:http://www.spiegel.de/international/world/0,1518,682613,00.html 16 Johann Grolle and Veronika Hackenbroch. Interview with Epidemiologist Tom Jefferson – ‘A Whole Industry Is WaitingFor A Pandemic’. Spiegel Online 07/21/2009: http://www.spiegel.de/international/world/0,1518,637119,00.html17 Enserink, Martin. In Holland, the Public Face of Flu Takes a Hit. Science. 16 October 2009. Vol 326, 350-351.
18 Ekkelenkamp, Miquel. Mexican flu: a bad and expensive joke. Nrc.nl>archief. 12/05/2009:http://vorige.nrc.nl/article2239027.ece19 Doubting the benefits of influenza vaccines is dangerous from both a scientific and ethical point of view. EuropeanScientists Fighting Influenza. Press message: 26 October 2011:http://www.eswi.org/userfiles/files/ESWI_press%20release.pdf20 Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E. Vaccines for preventing influenza inhealthy adults. The Cochrane Library. Published Online: 7 JUL 2010. Assessed as up-to-date: 2 JUN 2010:http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001269.pub4/abstract An open letter to the NSABB re the political and ethical implications of lethal virus development
________________________________________________________________________ and the systematic review and meta-analysispublished in the Lancet, i.e. A paper on whichDr Osterhaus and Dr Fouchier are included as authors should also be included in the mix, i.e.
hampers development of virus-specific CD8+ T cellimmunity in childre The WHO has indicated we are experiencing a .
, advised: “Vaccines now are viewed as a crucial path to growth, as drugcompanies look for ways to offset a slowing of prescription-medicine sales amid intensifyinggeneric competition and government pressure to restrain prices under the federal health-careoverhaul”In a report in in September 2011, Debora MacKenzie says: “While therest of the pharmaceutical sector struggles to keep afloat as expiring patents send profitsplummeting, the vaccine industry has become remarkably buoyant.” A recent press release on PR Newswire (January 2012) titled Opportunities and Challenges: Worldwide Forecast notes: the “last few years have seen renewedinterest in the vaccines market, overcoming the prevailing view that vaccines are a low-marginbusiness with high barriers to entry. The flu vaccines market has been at the forefront of thistrend, partially fuelled by the fear of an impending pandemic. As a result global influenza vaccinemarket has experienced phenomenal growth in recent years at a compound annual growth rate ofmore than 65% between 2008 and 2010. This growth was mainly driven by the global spread ofH1N1 influenza. But in the year 2011 H1N1 pandemic flu vaccine market declined due to waningthreat of swine flu disease. However seasonal influenza vaccine market is predicted to grow yearon year and cross US$ 4 Billion by 2015.” Obviously there is big money in flu vaccines…
It is time for a broad investigation of the ever-expanding ‘influenza industry’, including
scrutiny of relationships between vaccine manufacturers and governments and other
public bodies. (Consideration of the
also needs to be included in
this investigation.)

This is particularly pressing in light of the ongoing calls for of medicalstaffand continuing to be vaccinated with flu vaccines ofquestionable benefi 21 Jefferson T, Di Pietrantonj C, Al-Ansary LA, Ferroni E, Thorning S, Thomas RE. Vaccines for preventing influenza in theelderly. The Cochrane Library. Published Online: 17 FEB 2010. Assessed as up-to-date: 6 OCT 2009:http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004876.pub3/abstract 22 Osterholm MT, Kelley NS, Sommer A, Belongiz EA. Efficacy and effectiveness of influenza vaccines: a systematicreview and meta-analysis. The Lancet Infectious Diseases. Vol. 12 No. 1 pp 36-44:http://minnesota.publicradio.org/features/2011/10/documents/flu.pdf 23 Bodewes R et al. Annual Vaccination against Influenza Virus Hampers Development of Virus-Specific CD8+ T CellImmunity in Children. Journal of Virology. 2011 Nov;85(22):11995-2000. Epub 2011 Aug 31:http://www.asm.org/asm/images/pdf/Communications/tips/2011/1111flu.pdf 24 WHO, UNICEF, World Bank, State of the world’s vaccines and immunization, 3rd ed. Geneva, World HealthOrganization, 2009: http://whqlibdoc.who.int/publications/2009/9789241563864_eng.pdf25 Linda A Johnson. Vaccines become drugmakers’ profit boosters. Associated Press. Published in The ColumbusDispatch 30 November 2009:http://www.dispatch.com/content/stories/business/2009/11/30/vaccine_revolution.ART_ART_11-30-09_A10_7NFQQE7.html 26 Debora MacKenzie. Vaccines enjoy a healthy return. New Scientist. 28 September 2011. Magazine issue 2831:http://www.newscientist.com/article/dn20877-vaccines-enjoy-a-healthy-return.html27 Influenza Vaccine Market Opportunities and Challenges: Worldwide Forecast. PR Newswire. January 10 2012:http://www.marketwatch.com/story/influenza-vaccine-market-opportunities-and-challenges-worldwide-forecast-2012-01-1028 Jefferson T, Doshi P, Cohen D. Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trialdata. British Medical Journal. Tuesday, January 17. 2012: http://www.bmj.com/press-releases/2012/01/17/effects-tamiflu-still-uncertain-warn-experts-roche-continues-withhold-key-29 Sam Davidson. New rule to make flu shots mandatory for doctors. Influenza 121doc.co.uk. January 31 2012:http://www.121doc.co.uk/news/doctors-to-get-flu-shots-7407.html 30 See for example: National rollout as swine flu vaccine approved. The Age. 18 September 2009:http://www.theage.com.au/national/national-rollout-as-swine-flu-vaccine-approved-20090918-fuyz.html and ‘Yuk’ factor: An open letter to the NSABB re the political and ethical implications of lethal virus development
________________________________________________________________________ In his paper rofessor Anwar Ul Haque of the PakistanInstitute of Medical Sciences provides an interesting perspective on flu vaccination in developingcountries: …the health budget in the “3rd” world countries is very small. Even most part ofthis lean budget is stolen away! For example useless and unwarranted vaccineslike Swine Flu vaccines are sold to suck the budget intended for the poorpatients.(6-30) The corrupt elements use the power and stature of World HealthOrganization (WHO) and armaments of sophisticated media to create panic tofool Governments and public into buying these vaccines on the expense oftreatments for far more common diseases such as malaria, anemia, tuberculosisand malnourishment etc.
Some manufacturer of Swine Flu vaccines had become the WHO “experts” and promoted the sale of the vaccines from theplatform of WHO. In order to sale these unwarranted vaccines on mass leveland thus earning billions o[f] Euros they even changed the basic definition ofpandemic.(27-31) In the conclusion to his paper on corruption in government hospitals, Professor Ul Haque says: For brin[g]ing health change the doctors and other educated people of the
society have to play their active role. Freedom of expression, honest and
fair evaluation and strict continuing accountability must be put in place.

Dr Keim, what steps are the NSABB taking to ensure there is appropriate political and
ethical representation at the meeting to discuss bird flu research, and an objective and
transparent recording of the proceedings?

In the interests of transparency, I request the matters raised in this letter be addressed in theNSABB’s forthcoming statement, which you have previously indicated will be published in Natureand Science this week.
In particular, I suggest it is imperative to clarify the United States’ position on lethal virus
development in relation to its obligations under the
.
Dr Keim, I would appreciate your early response to the questions raised above. I also requestyour advice on the progress of your discussions with Professor Palese and his colleaguesregarding publication of their letter to the NSABB.
Elizabeth Hart
Note: I have initiated discussion on this topic, from a layperson’s perspective, on the
under the title
flying snot promotes flu jabs. ABC News. 6 April 2009: http://www.abc.net.au/news/2009-04-06/yuk-factor-flying-snot-promotes-flu-jabs/164290631 Anwar Ul Haque. Corruption in the Government Hospitals. International Journal of Pathology; 2010; 8(2): 73-81:http://www.jpathology.com/Issues/IJP%20Vol%208-2/Corruption%20in%20the%20governemnt%20hospital-Review%20Artical.8.2.pdf

Source: http://users.on.net/~peter.hart/Open_Letter_to_Paul_Keim_NSABB_31_Jan_2012.pdf

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