Category Archives: Flu Vaccine

Arrogant scientists and dangerous ‘gain-of-function’ experiments – a letter to the US National Science Advisory Board for Biosecurity (NSABB)

????????????????????????????????????????????????????????????????????????????????????????????????????????In recent years there has been a furore in the international scientific community about controversial lab-engineering of viruses (now described as ‘gain-of-function’ experiments), see for example:

Now the United States Government has announced a pause on funding for any new studies that include certain gain-of-function experiments involving influenza, SARS, and MERS viruses, specifically research that may enhance pathogenicity and/or transmissibility in mammals via the respiratory route.

This pause on funding of gain-of-function experiments is coupled with a review of biosafety and biosecurity in the US in light of serious biosafety breaches involving smallpox, H5N1, and anthrax in US facilities.

On 22 October 2014, the US National Science Advisory Board for Biosecurity (NSABB) convened a meeting to commence a deliberative process to address key questions about the risks and benefits of gain-of-function studies.

As a global citizen, I took the opportunity to submit my perspective to the NSABB, including raising concern about the arrogant and irresponsible attitude of scientists in regards to lab-engineering of potentially lethal pathogens, and providing an example.  

This builds on submissions I have made previously to the NSABB (31 January 2012) and to the US CDC/HHS (17 December 2012).

See below my recent letter to Dr Samuel L Stanley, Chair of the NSABB:

____________________________________

22 October 2014

Dr Stanley

Re the upcoming NSABB meeting to discuss controversial ‘gain of function’ research, to be held on 22 October 2014.[1]

As a global citizen, I wish to register my opposition to lab-engineering of potentially lethal pathogens being sponsored by the United States Government and other parties.

There appears to be seriously inadequate ethical oversight of this dangerous research, which may be taking place around the world in an unknown number of facilities in universities, research laboratories and pharmaceutical companies.

It is most concerning that there is an arrogant attitude about this type of research in the scientific community, perhaps exemplified most tellingly in the comments of Vincent Racaniello, Professor of Microbiology and Immunology in the College of Physicians and Surgeons of Columbia University.

In an interview re controversial influenza H7N9 gain of function experiments[2], broadcast on Dispatch Radio in August 2013[3], Professor Racaniello stated:

So a ‘gain of function’[4] simply means that you take a virus and you change it in some way so it does something new, so it does something that it didn’t do before.  That’s all that means.  It’s quite simple.  So you could for example take this H7N9 virus and make it resistant to an anti-viral drug, that would be a gain of function…

So, to really understand how this virus works, and really any other virus, we do gain of function studies all the time. We don’t make a big deal of it, we don’t write letters telling the world that we’re going to do them because that’s not the way science works.  Science works by just doing your experiments.  We do this because we would like to see what kinds of changes would lead to a gain of function, and what would be the consequences. 

So, in the case of this virus, these investigators want to make the virus drug resistant.  As you know, there are a couple of anti-virals that you can use if you get influenza – Tamiflu, Relenza – and these investigators want to make the virus resistant.  And the reason they want to do that is to see if a drug resistant mutant would have any properties that would make it scarier in people. 

So there is really a goal to these experiments.  They want to know if you change the virus what might be the consequences for people.  And as I said this is done all the time but these virologists decided to tell the world about it. 

(My emphasis.)  (Full transcript of interview attached to view comments in context.)

Professor Racaniello says “we do gain of function studies all the time.  We don’t make a big deal of it, we don’t write letters telling the world that we’re going to do them because that’s not the way science works.  Science works by just doing your experiments.”  Professor Racaniello seems to infer that it is acceptable for scientists to manipulate viruses, e.g. make a “virus drug resistant…to see if a drug resistant mutant would have any properties that would make it scarier in people” without telling “the world about it”.  (I challenged Professor Racaniello about his comments on his Virology blog post “Virologists plan influenza H7N9 gain of function experiments”[5], but he did not respond.)

I suggest Professor Racaniello’s attitude is arrogant and irresponsible. 

How many other scientists are undertaking this type of research “without telling the world about it”, and with scant regard for potentially disastrous consequences?  For example, are scientists manipulating the ebola virus to “make it scarier in people”?

As well as scientists manipulating potentially deadly pathogens with little or no effective ethical oversight, careless practices are also a serious problem in some laboratories.  A CIDRAP report on lab biosafety refers to “recent incidents in which lab workers at the Centers for Disease Control and Prevention (CDC) inadvertently sent potentially viable Bacillus anthracis samples to a low-containment lab and shipped nonpathogenic avian flu virus samples contaminated with the deadly H5N1 virus to a US Department of Agriculture lab.  Those mishaps were followed by the discovery of smallpox virus samples in a Food and Drug Administration facility”.[6]

Following these significant lapses in biosafety and biosecurity at US Federal research facilities, The White House Office of Science and Technology Policy advises the US Government “has taken a number of steps to promote and enhance the Nation’s biosafety and biosecurity, including immediate and longer term measures to review activities specifically related to the storage and handling of infectious agents”.[7]

It has also been announced that there will be a pause in US Government funding of any new studies involving gain of function experiments with influenza, SARS, and MERS, and a ‘deliberative process’ is being launched to assess the potential risks and benefits associated with gain of function research.[8]  The NSABB and the National Research Council (NRC) of the National Academies will be involved in this deliberative process, commencing with a NSABB meeting on 22 October 2014.[9]

Francis S Collins, Director of the National Institutes of Health, notes that “public involvement in this deliberative process is key, and the process is thus designed to be transparent, accessible, and open to input from all sources”.  Dr Collins encourages us to “follow these deliberations closely”.[10]

I hope that Dr Collins is paying more than lip service to the notion that “public involvement in this deliberative process is key”.  Sponsoring of potentially dangerous gain of function research, and mishandling of pathogens, are matters of serious concern for global citizens.  Discussion on these matters should not be restricted to scientists and bureaucrats with possible conflicts of interest.

In regards to ‘public involvement’ in this matter, I have sought to make submissions previously, ie:

  • In January 2012 I forwarded an open letter to the NSABB re the political and ethical implications of lethal virus development to Dr Paul Keim, then Acting Chair of the NSABB, and Dr Michael Osterholm, then a member of the NSABB. Beyond acknowledgement of receipt of my letter, I received no further response to the important matters raised, e.g. my suggestion that by sponsoring development of a potentially lethal flu virus, the United States could be in breach of the Biological Weapons Convention.  Please see attached my letter to Dr Keim for further background.

I request that the recently revised NSABB membership consider this submission, and my previous submissions as detailed above and attached, in the deliberative process for gain of function research.  I also question what processes are being put in place to allow interested parties such as myself to be kept abreast of developments on this matter, e.g. email updates?

Sincerely

Elizabeth Hart

Please note this letter will be forwarded to other parties for information, including the cc list below

cc:

  • Francis S Collins, US National Institutes of Health
  • Anthony Fauci, US National Institute of Allergy and Infectious Diseases
  • Ralph J. Cicerone, US National Academy of Sciences
  • Paul Keim, past Chair of the NSABB
  • Michael Osterholm, past member of the NSABB
  • Vincent Racaniello, Columbia University
  • Ron Fouchier, Erasmus MC
  • Ab Osterhaus, Erasmus MC
  • Yoshihiro Kawaoka, University of Wisconsin-Madison
  • Marc Lipsitch, Harvard School of Public Health
  • Peter Palese, Mount Sinai School of Medicine
  • Tom Jefferson, Cochrane Vaccines Field
  • Peter Gøtzsche, The Nordic Cochrane Centre
  • Lord Robert May, Oxford University
  • Philip Campbell and Declan Butler, Nature
  • Caroline Ash and Martin Enserink, Science
  • Fiona Godlee and Deborah Cohen, British Medical Journal
  • Brian Martin, University of Wollongong
  • Bea Mies, Independent Vaccine Investigator
  • Monika Peichl, Independent Vaccine Investigator
  • Carolyn Mosby, National Institutes of Health

References:  (Links and hyperlinks active as at 22 October 2014.)

[1] Doing Diligence to Assess the Risks and Benefits of Life Sciences Gain-of-Function Research. Issued by The White House Office of Science and Technology Policy. 17 October 2014: http://www.whitehouse.gov/blog/2014/10/17/doing-diligence-assess-risks-and-benefits-life-sciences-gain-function-research

[2] The interview was about the proposed gain of function experiments on H7N9, which were discussed in a letter by Ron A.M. Fouchier, Yoshihiro Kawaoka and 20 co-authors, published in Nature (Nature 500, 150-151, 8 August 2013) and Science (Science 9 August 2013: Vol. 341 no. 6146 pp. 612-613).

[3] Vincent Racaniello spoke with Robert Herriman, executive director of The Global Dispatch, about the proposed avian influenza H7N9 virus gain of function experiments on Dispatch Radio, August 2013: http://www.virology.ws/2013/08/13/influenza-h7n9-gain-of-function-experiments-on-dispatch-radio/   I have also prepared a transcript of this interview which can be accessed via this link: http://users.on.net/~peter.hart/Racaniello_GOF_transcript_10_August_2013.pdf

[4] Screen shot of Vincent Racaniello’s description of ‘gain of function’, i.e. it “…simply means you take a virus and you change it in some way so it does something new… something that it didn’t do before.” http://users.on.net/~peter.hart/Gain%20of%20function%20Racaniello.PNG as depicted in Professor Racaniello’s interview on Dispatch Radio: http://www.virology.ws/2013/08/13/influenza-h7n9-gain-of-function-experiments-on-dispatch-radio/

[5] Virologists plan influenza H7N9 gain of function experiments. Published on virology blog, 7 August 2013: http://www.virology.ws/2013/08/07/virologists-plan-influenza-h7n9-gain-of-function-experiments/

[6] More voices call for action on lab biosafety. (Robert Roos). CIDRAP. 31 July 2014: http://www.cidrap.umn.edu/news-perspective/2014/07/more-voices-call-action-lab-biosafety

[7] Doing Diligence to Assess the Risks and Benefits of Life Sciences Gain-of-Function Research. Issued by The White House Office of Science and Technology Policy. 17 October 2014: http://www.whitehouse.gov/blog/2014/10/17/doing-diligence-assess-risks-and-benefits-life-sciences-gain-function-research

[8] Ibid.

[9] More information about the NSABB meeting to be held on 22 October, including a hyperlink to the draft agenda, is accessible via this link: http://osp.od.nih.gov/office-biotechnology-activities/event/2014-10-22-121500-2014-10-22-200000/nsabb-meeting

[10] Statement on Funding Pause on Certain Types of Gain-of-Function Research.  Issued by Francis S Collins, Director, National Institutes of Health. 17 October 2014: http://www.nih.gov/about/director/10172014_statement_gof.htm

UPDATE: Vaccine safety and aluminium – a challenge to Cochrane

Cochrane2Re my previous post about my letter to  Professor Peter Gøtzsche, challenging a systematic review prepared by members of the Cochrane Vaccines Field, i.e. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence.

Professor Gøtzsche has responded to my letter, encouraging me to “submit a criticism” on this important matter.

I have forwarded a follow-up letter in this regard, which includes reference to my previous correspondence with Dr Tom Jefferson, and also draws parallels between human and animal vaccination, please see below:

______________________

17 July 2014

Professor Gøtzsche

RE:  Vaccine safety and aluminium adjuvants

Thank you for your response[1] to my letter dated 8 July 2014 which challenges a systematic review prepared by the Cochrane Vaccines Field i.e. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence.[2]

In your response you encourage me to “submit a criticism” on this important matter to The Cochrane Collaboration. 

As noted in my previous letter, the systematic review in question was prepared by members of the Cochrane Vaccines Field, i.e. Tom Jefferson, Melanie Rudin and Carlo Di Pietrantonj, and was published in The Lancet Infectious Diseases in 2004 (behind the paywall).  The review is listed in the bibliography on the Cochrane Vaccines Field website, but is not accessible online on The Cochrane Collaboration website, so I am unable to make an online comment.

Professor Gøtzsche, as you have encouraged me to make a submission, can you please clarify how I should do this?

For your information, I originally contacted Dr Jefferson directly about this matter in March 2013.  (I had previously contacted Dr Jefferson on other vaccine-related matters.  He is also formally copied on my submissions re controversial ‘gain-of-function’ research[3] in the influenza industry, see my letter to the NSABB Jan 2012 and my submission to the US CDC/HHS Dec 2012.)

Please see below the contents of my email forwarded to Dr Jefferson on 24 March 2013 in regards to his systematic review of adverse events after immunisation with aluminium-containing DTP vaccines.  (Given my previous correspondence with Dr Jefferson, the tone is informal.  I have added some references in the endnotes):

Tom

I’m reading your review: “Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence”  (The Lancet Infectious Diseases. Vol. 4 2004.)

The summary of your review concludes: “Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken.”   (My emphasis.)

Your review notes:  “The results of our review should be interpreted within the limited quantity and quality of available evidence.  Within these limits, we found no evidence that aluminium salts cause any serious or long-lasting adverse events…”

So, you admit the quantity and quality of the evidence in your review was limited, but you still say that “we do not recommend that any further research on this topic is undertaken“.

Why would you say that?

I suggest you did not have enough information to say “we do not recommend that any further research on this topic is undertaken.”  Your review just plays into the hands of vaccine manufacturers like GlaxoSmithKline and Merck etc who are pushing repeat revaccinations with aluminium adjuvanted vaccines of questionable value. 

Vaccines with aluminium adjuvants such as DTaP (repeat ‘boosters’ being recommended for all ages) and HPV x 3 shots for children, etc are now being pushed on the population.  Who knows what the cumulative effect of this repeated vaccination with these vaccines might be?  Have there been any long-term studies?  I would suspect no…

My investigation into companion animal vaccines has led me to be very concerned about vaccines with an aluminium adjuvant.  Do I have masses of material in the “peer-reviewed literature” to back me up?  No, and neither have I had the time to do a full-blown literature search, what with spending so much of my time investigating questionable MMR ‘boosters’, HPV, flu, pertussis vaccination, etc, because of all the misinformation spread by the ‘scientific’ establishment…  Who would fund such research anyway?

Experts in veterinary medicine have been calling for a decrease of live and inactivated vaccination of companion animals because of the risk of adverse reaction to vaccines.[4]  I’m becoming more concerned about the non-infectious/inactivated vaccines with aluminium adjuvants, (e.g. bordetella bronchiseptica with aluminium) that are given to many dogs every year, and now humans are being pressed to have regular revaccinations with aluminium adjuvanted vaccines (e.g. DTaP and HPV).

For information, see attached a presentation by Michael J Day[5], from a World Small Animal Veterinary Association Congress (2004) in which he says:  “We now recognize that vaccines (particularly multicomponent, modified live products) appear to be able to trigger a range of immune-mediated and autoimmune diseases.  For example, much attention has recently focused on vaccines as an initiator of immune-mediated haemolytic anaemia in the dog.  The mechanism by which this effect occurs is not well investigated.  In theory, three separate components of the vaccine might be involved.  Many vaccines contain adjuvant (particularly alum), the function of which is, in part, to non-specifically activate the immune system.  It is theoretically possible that this activation might include autoreactive lymphocytes, and as alum is very effective at stimulating antibody responses, the activation of B cells and their particular helper T cells (Th2 cells) might readily arise….”  (My emphasis.)

Ref: 29th World Congress of the World Small Animal Veterinary Association October 6-9 2004, Rhodes, Greece.  Michael Day is an author of the WSAVA Guidelines for Dogs and Cats, 2010: http://www.wsava.org/sites/default/files/VaccinationGuidelines2010.pdf

Also, here’s a quote from a DVM roundtable of vaccine experts, (December 1988)[6], which included Ron Schultz, Jonas Salk, Ian Tizard and others during which Ian Tizard said:  “And yet, the use of poorly understood adjuvants has a long and distinguished history in vaccinology.  We’ve been using alum since the 1920s and are still not sure how it works. It’s also fair to say that we’ve been very conservative in our use of adjuvants.  To the best of my knowledge, alum is still the only adjuvant used in human vaccines…”  (My emphasis.)

In 2013, do we yet know how alum works in vaccines?

It is interesting to note that pregnant women are currently being urged to have DTaP revaccinations because of the resurgence of pertussis.  However, it has been reported that the pertussis circulating is a new strain, so what is the point of revaccinating with the existing vaccine?  Also, I don’t buy this idea of a vaccine that ‘wanes’.  Either a vaccine immunises for life or forget it, we have been conned big time with these annual flu vaccinations and repeat DTaPs etc.  

On the topic of pregnant women and the DTaP, it is interesting to note that vaccination guidelines for dogs say:  “Should a pregnant dog be vaccinated?  Vaccination with MLV (attenuated) and/or killed (inactivated) vaccines during pregnancy should be avoided, if possible, to avoid potential injury to the fetus. There are exceptions, especially in shelters, where vaccination would be advised if the pregnant dog has never been vaccinated and there is risk of exposure to a highly pathogenic virus (e.g., CDV, CPV-2).  (My emphasis.)

Reference: 2011 AAHA Canine Vaccination Guidelines: http://www.aahanet.org/PublicDocuments/CanineVaccineGuidelines.pdf

Are pregnant women being properly informed about pertussis, about the ‘new strain’, and about questionable vaccines that wane?  Have the possible long-term deleterious effects of vaccination of pregnant women with aluminium adjuvanted vaccines been properly researched?  I suspect not…

Tom, I suggest your Cochrane Review of aluminium-containing DTP vaccines is a bit of a worry in that it may have created a poorly evidenced acceptance of the safety of aluminium-adjuvanted vaccines.

Cochrane Reviews don’t always get it right, as we know from Hayashi / Tamiflu…[7]

I would appreciate your response on this matter.

Regards

Elizabeth

Dr Jefferson responded to my email saying: “Very simple: it is not a Cochrane review”.[8]  Obviously this brief reply was an inadequate response to the serious matters I had raised.  I was also bemused by his statement that the systematic review prepared by the Cochrane Vaccines Field was “not a Cochrane review”.  The review as published in The Lancet Infectious Diseases clearly identifies the authors as members of the Cochrane Vaccines Field, so surely The Cochrane Collaboration has a responsibility to be accountable for the recommendations of this review?

Professor Gøtzsche, as you have encouraged me to “submit a criticism” on this important matter, I would appreciate your advice as to how I can successfully make a submission to The Cochrane Collaboration.

I look forward to your response.

Sincerely

Elizabeth Hart

https://over-vaccination.net/                              

*Please note, in addition to the cc list below, this letter will be circulated to other parties, and has also been published on my website.

cc:

  • Dr Tom Jefferson, Cochrane Vaccines Field
  • Mr Mark Wilson, CEO, The Cochrane Collaboration
  • Professor Paul Glasziou, Bond University
  • Professor Chris Del Mar, Bond University
  • Mr Ray Moynihan, Bond University
  • A/Professor Peter Doshi, University of Maryland
  • Dr Fiona Godlee, British Medical Journal
  • Professor Peter Collignon, Australian National University
  • Professor Christopher Exley, Keele University
  • Professor Chris Shaw, University of British Columbia
  • Dr Lucija Tomljenovic, University of British Columbia
  • Professor Warwick Anderson, NHMRC
  • Professor Ian Olver, NHMRC Australian Health Ethics Committee
  • Professor Ian Frazer, University of Queensland
  • A/Professor Ruiting Lan, University of New South Wales
  • Professor Lyn Gilbert, University of Sydney
  • Dr Linjie Zhang, Federal University of Rio Grande
  • Professor Ronald Schultz, Vaccination Guidelines Group, World Small Animal Veterinary Association
  • Professor Michael Day, Vaccination Guidelines Group, World Small Animal Veterinary Association
  • Professor Brian Martin, University of Wollongong
  • Ms Bea Mies, Independent Vaccine Investigator
  • Ms Monika Peichl, Independent Vaccine Investigator

References: (All links accessible as at 17 July 2014.  It may be necessary to copy and paste long links into a web browser.)

[1] Email from Professor Peter Gøtzsche, 9 July 2014.

[2] Jefferson T, Rudin M, Di Pietrantoni C. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence.  Lancet Infect Dis. 2004 Feb; 4(2):84-90: http://www.ncbi.nlm.nih.gov/pubmed/14871632  This review is also listed in the Cochrane Vaccines Field Bibliography: http://vaccinesfield.cochrane.org/bibliography-2003

[3] A recent editorial in Nature provides an update on this controversial research: Biosafety in the balance. 25June 2014 (corrected 4 July 2014): http://www.nature.com/news/biosafety-in-the-balance-1.15447

[4] For example the World Small Animal Veterinary Association Guidelines for the Vaccination of Dogs and Cats state “we should aim to reduce the ‘vaccine load’ on individual animals in order to minimize the potential for adverse reactions to vaccine products”.  The Vaccination Guidelines Group also acknowledges that “there is gross under-reporting of vaccine-associated adverse events which impedes knowledge of the ongoing safety of these products” Day MJ, Horzinek MC and Schultz RD. Journal of Small Animal Practice. Vol. 51. June 2010: http://www.wsava.org/sites/default/files/VaccinationGuidelines2010.pdf  Also refer to the WSAVA Vaccination Guidelines webpage: http://www.wsava.org/guidelines/vaccination-guidelines

[5] Day MJ. Infectious Triggers of Immune-Mediated Disease. 29th World Congress of the World Small Animal Veterinary Association. October 6-9 2004, Rhodes Greece: http://www.vin.com/proceedings/Proceedings.plx?CID=WSAVA2004&Category=&PID=8599&O=Generic

[6] Safety, efficacy heart of vaccine use; experts discuss pros, cons. DVM roundtable. DVM December 1988.

[7] Tom Jefferson. Hayashi’s Problem:  Dr Keiji Hayashi’s question re Cochrane’s Tamiflu/Oseltamivir review: “We have some questions on the conclusion in your Oseltamivir review especially about the prevention of complication. You described that “Oseltamivir 150 mg daily prevented lower respiratory tract complications (OR 0.32, 95% CI 0.18 to 0.57).” (in abstract). However, we have found that this conclusion is based on the other review (Kaiser2003) and not on your own data analysis. The authors of the review were four employees of F. Hoffman-La Roche Ltd, one paid consultant to F. Hoffman-La Roche Ltd and Kaiser. We cannot find any raw data about this conclusion from your review. Kaiser’s review included 10 RCTs; two RCTs (Nicholson 2000 and Treanor 2003) were published as articles in the peer-reviewed medical journal (JAMA and Lancet), but other 8 RCTs were proceedings of congress (5 RCTs), abstracts of the congress (one RCT) and meeting (one RCT) and data on file, Hoffmann-La Roche, Inc, Nutley, NJ (one RCT). The lower respiratory tract complication rates of these articles were summarized on table: there was no significant difference between Oseltamivir and placebo, and their Odds Ratio’s (ORs) were 1.81. But ORs of other 8 RCTs were 4.37. We strongly suppose that the reviewer’s conclusion about the complications was mainly determined by these 8 RCTs, we should appraise the 8 trials rigidly. Without this process it’s difficult to conclude that oseltamivir can prevent lower respiratory tract complications.”  (Powerpoint slide 12): http://chmg.cochrane.org/sites/chmg.cochrane.org/files/uploads/Jefferson_Hayashi’s%20problem.pdf

[8] Email from Tom Jefferson, 24 March 2013.

The Conversation – a marketing arm for the university and research sector?

????????????????????????????????????????????????????????????????????????????????The university and CSIRO-funded The Conversation website(1) publishes articles promoting vaccination, but appears reluctant to provide critical analysis on the worth of individual vaccine products. Indeed critical analysis of vaccines seems to be limited to comments on articles, often by members of the general public.

The dearth of critical analysis of individual vaccines is a major failing on The Conversation website(2), particularly as the university and research sector has a vested interest in promoting lucrative vaccine products, e.g. the controversial HPV vaccine(3).  This lack of objectivity undermines trust in The Conversation(4).

The Conversation claims to be “an independent source of news and views, sourced from the academic and research community” introducing “new protocols and controls to help rebuild trust in journalism”, and believing in “open access and the free-flow of information.(4) The Conversation states: “We only allow authors to write on a subject on which they have proven expertise, which they must disclose alongside their article. Authors’ funding and potential conflicts of interest must be disclosed. Failure to do so carries a risk of being banned from contributing to the site.”(4)

Given its promise to be “an independent source of news and views, sourced from the academic and research community”(4), The Conversation’s support of the Stop the Australian (Anti) Vaccination Network (SAVN)(5) bears investigation.   The SAVN is a stalwart defender of mandated vaccination and will brook no dissent.  While the SAVN’s raison d’etre is ostensibly to oppose the controversial Australian Vaccination Network(6) and its spokesperson Meryl Dorey, in practice SAVN supporters have taken it upon themselves to stifle and patronise anybody who dares to question vaccination practice in any way, as can be seen in The Conversation discussion threads listed below.(7)

Rachael Dunlop is an administrator of the SAVN Facebook page(8), and Vice President of Australian Skeptics Inc(9).  Her articles on vaccination are published on The Conversation.  Contrary to The Conversation’s assurance that “we only allow authors to write on a subject on which they have proven expertise”(4), Rachael Dunlop’s profile on The Conversation website(10) provides no indication that she has “proven expertise” in the wide range of vaccine products on the Australian National Immunisation Program Schedule(11).  While Rachael Dunlop is given carte blanche to publish her opinions on vaccination on The Conversation(12), others of us relegated to the comments section are intimidated by the threat of censorship.  For instance two of my comments were censored on Rachael Dunlop’s article “A view on: vaccination myths”(13).

In his support for The Conversation, Professor Peter Doherty, Nobel Laureate, says: “The whole motivation behind this was to open communication between people in our universities and institutes of higher education and the general public…None of us want to live in an ivory tower, we all want to be part of society.  So how do we do that?  It has been difficult to do that in conventional newspaper and media formats because they have their own priorities.  So we started The Conversation…”(14)

Given The Conversation’s general reluctance to critically analyse individual vaccine products, cynics might wonder if The Conversation has its ‘own priorities’, principally to do with selling the products of the university and research sector?   Is The Conversation merely a marketing arm for the university and research sector?

Vaccines of questionable value are being added to national vaccination schedules.  Mass populations of children are being vaccinated against diseases which may never pose a serious threat for them, e.g. human papillomavirus(15).  It is questionable whether ‘informed consent’ is being properly obtained before these medical interventions.

Vaccine products are being developed for more and more diseases e.g. novovirus(16), chlamydia(17), skin cancer(18), herpes(19), HIV(20), malaria(21) etc, etc, yet nobody has any idea of the long term cumulative effect of all these medical interventions, or ‘unintended consequences’ for disease development, consider for example the possible implications of genotype replacement with HPV vaccination(22); vaccine-related reassortment of rotavirus(23); HBV S protein mutations after vaccination(24); and increasing selection among the B. pertussis population in Australia in favor of strains carrying prn2 andptxP3 under the pressure of acellular vaccine–induced immunity(25).

Aggressive marketing by the pharmaceutical industry and industry-affiliated ‘experts’, including lobbying for compulsory vaccination with vaccines of dubious value, is threatening citizens’ autonomy.  It seems we are now expected to meekly accept every vaccine product manufactured by the vaccine industry.  

The increasingly lucrative vaccine industry benefits from the oppressive climate that has developed on the subject of vaccination.

The potential conflicts of interests of academics working in the areas of vaccine development and promotion, and the influence of these academics on government policy, needs to be examined.  It’s time there was an investigation into the relationships between governments, the vaccine industry, and the industry’s handmaidens in the scientific/medical establishment, but who can we trust to do that?  The mainstream media has generally been completely useless on this matter, and incapable of providing critical analysis, merely supporting the status quo(26), likewise The Conversation.

Citizens must be allowed to have a rational debate on this important subject to ensure public confidence in vaccination practice.  All vaccination recommendations must be transparently evidence-based.

It’s time for The Conversation to lift its game on this subject and provide some objective critical analysis of individual vaccine products, and the lucrative international vaccine market.

For discussion on controversial vaccine products see:  

I have provided critical comment(27*) on a number of The Conversation’s articles pertinent to vaccination, see list below:  

References: (Links current as at 12 November 2013.)

1. Partners and funders of The Conversation: https://theconversation.com/au/partners

2. Our charter – The Conversation: https://theconversation.com/au/our_charter

3. Also refer to Ian Frazer. Catch cancer? No thanks, I’d rather have a shot! The Conversation 10 July 2012: http://theconversation.com/catch-cancer-no-thanks-id-rather-have-a-shot-7568

4. Who we are – The Conversation: https://theconversation.com/au/who_we_are

5. Stop the Australian (Anti) Vaccination Network Facebook page: https://www.facebook.com/stopavn

6. Australian Vaccination Network: http://avn.org.au/

7. This has been my personal experience – see responses to Elizabeth Hart on The Conversation discussion threads listed above.  As far as I am aware, editors at The Conversation have done little to address concerns about vaccines of questionable value such as the controversial HPV vaccine; the arbitrary second dose of the measles/mumps/rubella (MMR) live vaccine; annual flu vaccination and controversial ‘gain of function research’; or pertussis ‘boosters’ of the existing vaccine against the new strain.

8. The disclosure statement on Rachael Dunlop’s article “A view on: vaccination myths” on The Conversation, 28 May 2013, notes that she is “an administrator of the Stop the AVN Facebook page”: https://theconversation.com/a-view-on-vaccination-myths-14699

9. Australian Skeptics: http://www.skeptics.com.au/contact/nsw/

10. Rachael Dunlop’s profile on The Conversation website http://theconversation.com/profiles/rachael-dunlop-4133/profile_bio

11. Australian National Immunisation Program Schedule: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

12. Rachael Dunlop. Six myths about vaccination – and why they’re wrong. The Conversation, 26 April 2013: http://theconversation.com/six-myths-about-vaccination-and-why-theyre-wrong-13556

13. Rachael Dunlop. A view on: vaccination myths. The Conversation, 28 May 2013: https://theconversation.com/a-view-on-vaccination-myths-14699

14. Peter Doherty: Why I support The Conversation. Video on Who we are – The Conversation, quote starting at 0.30: https://theconversation.com/au/who_we_are

15. In an article on the university and CSIRO-funded The Conversation website, titled “Catch cancer? No thanks, I’d rather have a shot!”, Professor Ian Frazer states: “Through sexual activity, most of us will get infected with the genital papillomaviruses that can cause cancer. Fortunately, most of us get rid of them between 12 months to five years later without even knowing we’ve had the infection. Even if the infection persists, only a few individuals accumulate enough genetic mistakes in the virus-infected cell for these to acquire the properties of cancer cells”.  If only “a few individuals accumulate enough genetic mistakes in the virus-infected cell for these to acquire the properties of cancer cells”, is it really justifiable to coerce mass populations of children to have HPV vaccination, particularly as the long-term consequences of the HPV vaccine are unknown?  Refer to this link for further background: https://over-vaccination.net/questionable-vaccines/hpv-vax/

16. Takeda’s norovirus vaccine misses endpoint in early-phase trial. FierceVaccines, 7 October 2013: http://www.fiercevaccines.com/story/takedas-norovirus-vaccine-misses-endpoint-early-phase-trial/2013-10-07

17. Igietseme JU, Eko FO, Black CM. Chlamydia vaccines: recent developments and the role of adjuvants in future formulations. Expert Rev Vaccines. 2011 Nov;10(11):1585-96: http://www.ncbi.nlm.nih.gov/pubmed/22043957

18. Professor Ian Frazer close to creating skin cancer vaccine. News.com.au, 31 July 2011: http://www.news.com.au/technology/science/skin-cancer-vaccine-hope/story-fn5fsgyc-1226105179167

19. Allied Healthcare’s herpes simplex vaccine trial under way. 17 October 2013: http://www.proactiveinvestors.com.au/companies/news/49190/allied-healthcares-herpes-simplex-vaccine-trial-under-way-49190.html

20. Breakthrough in hunt for HIV vaccine as scientists capture ENV protein. News.com.au, 2 November 2013: http://www.news.com.au/technology/science/breakthrough-in-hunt-for-hiv-vaccine/story-fn5fsgyc-1226751689734

21. New malaria vaccine has its flaws, but it’s better than nothing. The Conversation, 9 October 2013: https://theconversation.com/new-malaria-vaccine-has-its-flaws-but-its-better-than-nothing-19020

22. Pons-Salort M et al. Exploring individual HPV coinfections is essential to predict HPV-vaccination impact on genotype distribution: a model-based approach. Vaccine. 2013 Feb 6;31(8):1238-45: http://www.ncbi.nlm.nih.gov/pubmed/23246257

23. Tatiana Lundgren Rose et al. Evidence of vaccine-related reassortment of rotavirus, Brazil, 2008-2010. Emerging Infectious Diseases. Volume 19, Number 11 – November 2013: http://wwwnc.cdc.gov/eid/article/19/11/12-1407_article.htm

24. Bian T et al. Change in hepatitis B virus large surface antigen variant prevalence 13 years after implementation of a universal vaccination program in China. J. Virol. 2013 Nov;87(22):12196-206: http://www.ncbi.nlm.nih.gov/pubmed/24006443

25. Sophie Octavia et al. Newly emerging clones of Bordetella pertussis carrying prn2 and ptx3 alleles implicated in Australian pertussis epidemic in 2008-2010. J Infect Dis. (2012) 205 (8): 1220-1224: http://jid.oxfordjournals.org/content/205/8/1220

26. For example, the Murdoch media’s aggressive “No Jab, No Play” campaign contributes to the oppressive climate surrounding vaccination – “Big win for No Jab, No Play as NSW state cabinet approves tough new vaccination laws”. The Telegraph, 29 May 2013. In this climate it is difficult to raise legitimate questions about vaccination practice, e.g. questioning arbitrary revaccination of all children with the live measles/mumps/rubella (MMR) vaccine, as most children are likely to be immune after age appropriate vaccination with an effective first dose of this vaccine.

27. Elizabeth Hart, Independent Vaccine Investigator.  Comments on The Conversation: https://theconversation.com/profiles/elizabeth-hart-6978/activities  (*Edited to include additional articles 24 June 2014.)

Influenza: marketing vaccine by marketing disease

syringeIn a recent feature article published in the British Medical Journal, Peter Doshi discusses the marketing of influenza vaccine by marketing disease.

Here are some excerpts from the article:

Promotion of influenza vaccines is one of the most visible and aggressive public health policies today…Closer examination of influenza vaccine policies shows that although proponents employ the rhetoric of science, the studies underlying the policy are often of low quality, and do not substantiate officials’ claims. The vaccine might be less beneficial and less safe than has been claimed, and the threat of influenza appears overstated…

Selling sickness: what’s in a name?…Could influenza—a disease known for centuries, well defined in terms of its etiology, diagnosis, and prognosis—be yet one more case of disease mongering? I think it is. But unlike most stories of selling sickness, here the salesmen are public health officials, worried little about which brand of vaccine you get so long as they can convince you to take influenza seriously.

Marketing influenza vaccines thus involves marketing influenza as a threat of great proportions. The CDC’s website explains that “Flu seasons are unpredictable and can be severe,” citing a death toll of “3000 to a high of about 49 000 people.” However, a far less volatile and more reassuring picture of influenza seems likely if one considers that recorded deaths from influenza declined sharply over the middle of the 20th century, at least in the United States, all before the great expansion of vaccination campaigns in the 2000s, and despite three so-called “pandemics”

But perhaps the cleverest aspect of the influenza marketing strategy surrounds the claim that “flu” and “influenza” are the same. The distinction seems subtle, and purely semantic. But general lack of awareness of the difference might be the primary reason few people realize that even the ideal influenza vaccine, matched perfectly to circulating strains of wild influenza and capable of stopping all influenza viruses, can only deal with a small part of the “flu” problem because most “flu” appears to have nothing to do with influenza. Every year, hundreds of thousands of respiratory specimens are tested across the US. Of those tested, on average 16% are found to be influenza positive.

All influenza is “flu,” but only one in six “flus” might be influenza. It’s no wonder so many people feel that “flu shots” don’t work: for most flus, they can’t.

Read the entire article via this link: http://www.bmj.com/content/346/bmj.f3037

Reference: Doshi, P. Influenza: marketing vaccine by marketing disease. BMJ 2013;346:f3037

The reluctance to acknowledge adverse reactions to vaccination

Here’s a link to an article that illustrates the medical/scientific establishment’s reluctance to publish material that casts vaccination in a bad light: “Special Report: How vaccine scares cast shadows over science”.

Some quotes:  (Emphasis added.)

At a Finnish medical convention in January 2011, a colleague approached neurologist Markku Partinen, laid a hand on his shoulder and said: “Markku, it’s going to be a bad year for you.”

In the following months, other scientists ridiculed him, questioned his methods and motives, and raised doubts about his mental stability. Colleagues began crossing the street to avoid him, he says. 

Partinen, director of the Helsinki Sleep Clinic and Research Centre, had raised the alarm about a GlaxoSmithKline vaccine called Pandemrix. He had discovered the drug, used to protect people from H1N1 swine flu, may be linked to a jump in cases of narcolepsy, a rare sleep disorder, in children and young people. He knew his findings might help limit the risks of narcolepsy for other children around the world, but was fearful nonetheless. The work was bound to generate scientific suspicion and public anxiety. Indeed, he struggled to get his paper on the vaccine published.

His story underscores an increasingly tough challenge for scientists balancing compelling data with public concern over vaccines and their side effects. Treatments which stimulate immunity to disease are highly controversial. In the past couple of decades – especially after a British doctor made now-discredited claims linking the measles-mumps-rubella (MMR) vaccine to autism – the field has become even more charged. After the false alarm sounded by British doctor Andrew Wakefield, some scientists say they are more hesitant to credit reports of potential side effects from vaccines.

Partinen is keen to distance himself from Andrew Wakefield, calling Wakefield a “fake”.  It will be interesting to see how history views Andrew Wakefield, time will tell on that score…

The article provides another scientist’s perspective:

At a medical centre on the outskirts of Helsinki, another Finnish scientist agrees with Partinen’s results and is probing the mechanics of the Pandemrix-narcolepsy link, which she thinks may have to do with the vaccine’s super-charging effect on the immune system.

Outi Vaarala previously worked in research on autoimmune diseases and diabetes. Since crossing over into the field of vaccinology, she says she has found herself harangued in emails and phone calls by people on one side accusing her of undermining trust in vaccines, or on the other begging her to join an anti-vaccine crusade. 

“There’s not the kind of open discussion we used to have. You’re afraid you will lose your whole career if you say something bad,” says Vaarala. “When you’re dealing with vaccine it suddenly becomes like working in politics, or religion.”

Partinen tells of the problems he encountered in publishing his results:

Partinen attended another Helsinki medical conference last month, two years after he had been warned about difficult times ahead. But this time he was leading the first Nordic Symposium on Narcolepsy and its links to the H1N1 swine flu vaccine.

“When we found this, we wanted to publish our results and spread the news to the world because we knew Pandemrix was also being used in other countries,” he said. “But there were big problems.” 

Having double- and triple-checked his findings, Partinen approached the New England Journal of Medicine, one of the world’s most respected medical journals, and submitted his study for publication. He says the journal asked for several revisions to the paper, then finally declined to accept it.

“After that we sent it to The Lancet,” he said, stressing that this was the same journal which published the now discredited Wakefield paper.

While it is not unusual for such high-level medical journals to reject many papers, Partinen said he was shocked by the strength of The Lancet’s resistance to his.

“It was quite exceptional, they asked for revision and revision and revision,” Partinen said. “Then they said they’d made an editorial decision – that they couldn’t publish it because we didn’t know the (biological) mechanism (behind the link between narcolepsy and Pandemrix).”

Partinen argues that scientists don’t know the biological mechanisms behind a whole host of diseases – multiple sclerosis and diabetes to name just two – yet The Lancet is full of peer-reviewed papers about those.

Neither The Lancet nor the New England Medical Journal would comment on their editorial decisions.

By the time Partinen’s study was published – March 2012, in the open-access journal of the Public Library of Science, PLoS One – many more scientists had replicated his findings, the H1N1 flu pandemic that Pandemrix was designed to protect against had been declared over, and the vaccine’s use had been restricted.

For those with narcolepsy it was already too late.

“There is no doubt any more that there is a link,” Partinen said. “But it’s taken three years to get here.”

It’s alarming that the medical and scientific establishment, for example highly influential journals such as the New England Journal of Medicine and The Lancet, is reluctant to acknowledge safety problems with vaccines. 

The public is ill-served by this cover-up to protect the status quo.  

With so many vested interests in play, who can be relied upon to provide objective research into vaccine effectiveness and safety?

For more general discussion on flu vaccination see: Annual flu vaccination and the influenza industry

______________________________________________

Reference:

Special Report: How vaccine scares cast shadows over science. Thomson Reuters News & Insight. 21 March 2013: http://www.reuters.com/article/2013/03/21/us-vaccines-narcolepsy-specialreport-idUSBRE92K06620130321