Join me in Adelaide on 12 July to hear Friends of Science’s Assoc Prof Helen Marshall talk about her “proven” vaccination science for pregnant women

The punchline?

Is there any “proven” safe and effective evidence for providing whooping cough and influenza vaccines to pregnant women as claimed on Channel 9              by Assoc Prof Helen Marshall?

Before all of you in Adelaide decide to join me, first check out my letter to Assoc Prof Marshall, with lots of QUESTIONS, in relation to her forthcoming seminar at Adelaide University, entitled “Pregnancy Protection” – see Pregnancy Protection seminar by Assoc Prof Helen Marshall on Tues 12 July at 5.30pm at Adel Uni

 FROM : Graeme Little né Peter Pope

 DATE : 10 July 2016

ATT : Assoc Prof Helen Marshall, Friends of Science in Medicine Member; Deputy Director, University of Adelaide; Medical Director VIRTU & A-Prof Vaccinology / Affiliate Lecturer

tel: 08-8161-8115

Your Recent research

McMillan M, Porritt K, Kralik D, Costi L, Marshall H. Influenza vaccination during pregnancy: a systematic  review of foetal safety. Vaccine 2015;33(18):2108-2117 Conflicts disclosed by MARSHALL H. HM is supported by an NHMRC Career Development Fellowship (1016272). HM’s institution has received research grants from vaccine manufacturers GSK, Pfizer, Novartis and Sanofi Pasteur for investigator-led research. HM has been an investigator for studies funded by pharmaceutical companies INCLUDING Pfizer, GSK, Sanofi-Pasteur, Novartis. Travel support has been provided to her institutions by GSK and/or Sanofi-Pasteur for HM to present scientific data at international meetings. MM has received travel support by GSK to present at a national immunization conference. There are no other potential conflicts of interest.

Your Recent NHMRC grants This was a four year grant of $396,061 to Assoc Prof Marshall awarded in 2011, to which a NHMRC website search showed the following results:

Grant outcome summary (if available): No data available 

Publications arising from this project: No data available

Dear Assoc Prof Marshall,

I look forward to attending your “Pregnancy Protection” talk on Tuesday 12 July 2016, and hope you will be able to address some evidence based questions, which have been raised with me, by a mother unable to get answers from the head immunisation nurse and paediatrician at a leading Children’s Hospital.

These questions relate to the Australian Immunisation Handbook’s informed consent requirements, and are adapted to also address your recommendations of influenza and whooping cough vaccination drugs during pregnancy.

I include your preliminary comments in your brochure for reference taken from this link at Pregnancy Protection seminar by Assoc Prof Helen Marshall on Tues 12 July at 5.30pm at Adel Uni

“Pregnancy can be a confusing time for soon-to-be parents, raising many questions about how to ensure their baby’s health.

 While the benefits of infant immunisations are generally well accepted, they don’t commence until the child reaches six weeks, making their lives up until then a genuine ‘danger zone’.

 Immunisation during pregnancy offers another way to protect newborns during this period of vulnerability. Proven safe and effective—and offering the dual benefit of preventing disease in both expectant mothers and their infants—vaccines to protect against influenza and whooping cough are now widely recommended, including in Australia. Yet many pregnant women miss out on being protected, often due to lack of awareness, information or opportunity.

 This timely presentation will explore the evidence for vaccination during pregnancy, and how its access and uptake might be improved.”

Your recent additional comments on Channel 9 include claims you have strong data that show vaccinations during pregnancy are safe, and that it is really the best way to protect your newborn – these can be found at this link “WATCH: Vaccinating your baby before birth – a new hope in fighting childhood disease. @TomAngley9 explains. #9News”

My questions to you follow :

Q1. Do you agree your recommendations for immunisation require the immunisation provider to obtain a valid informed consent from a pregnant woman to the medical interventions of vaccination?

Q2. Do you agree that the Australian Immunisation Handbook guidelines (“Handbook”) should be taken into account from the immunisation provider in relation to the provision of your recommended vaccinations during pregnancy?

Q2A. Why do you assert the initial vaccinations take place at six weeks in your brochure when the Australian Immunisation Schedule states 2 months for the initial eight vaccinations? {****Addendum – since writing this letter, a member of my network has pointed out The Handbook does actually recommend starting at 6 weeks, even though the official “due” age is 2 months, here: under the heading “4.12.7 Recommendations, Infants and children, Primary doses”. It states that “giving a 1st dose at 6 weeks of age rather than 2 months of age is estimated to prevent an additional 8% of infant pertussis cases” and references these 2 articles: (Ref. 33) and (Ref. 49)}

Q2B. {***Addendum – see Q2A} – Have babies in South Australia been administered vaccinations at six weeks of age, and if so, what is the science to support this departure from the Australian Immunisation Handbook recommendations to be found at this link

Q2C. Why do you refer to a genuine danger zone” in the first six weeks of a baby’s life, but recommend pregnant women only have one vaccination out of the eight required under the Schedule at two months, excluding Hepatitis B, diphtheria, tetanus, Haemophilus influenzae type b, inactivated poliomyelitis (polio) (hepB-DTPa-Hib-IPV), Pneumococcal conjugate (13vPCV) and Rotavirus. What is the science behind this selective policy to address your notion of a “genuine danger zone”?

Q2D. Would you be prepared to announce at the commencement of your seminar on Tuesday 12 July 2016 that you have at least six conflicts of interest, I have identified so far, namely :

  • Pfizer,
  • GSK,
  • Sanofi-Pasteur,
  • Novartis
  • Membership of lobby group member, Friends of Science in Medicine, the prime opposition to the practice of natural therapies in Australia
  • NHMRC grant for $396,061 – NHMRC Career Development Fellowship (1016272), the authority which approves the Australian Immunisation Handbook, without reference to any mandatory guidelines which have been applied to NHMRC reviews of Natural Therapies. 

Q3 (Not relevant to vaccinations during pregnancy).

Q4 Do you accept the Handbook requirements at page 26 require that valid consent must be voluntary, and after conveyance of sufficient, appropriate and reliable information?

Q5 Do you agree that the Handbook guidelines differ from other NHMRC guidelines as stated on page 3 of the Handbook?

Q6 Do you agree the Handbook has omitted some or all of the mandatory guidelines detailed on the NHMRC website drafted pursuant to the NHMRC Act?

Q7 Are you able to provide any sufficient, appropriate, or reliable information to me, as to what information the Handbook has omitted by excluding reference to the mandatory guidelines normally applied by the NHMRC CEO, when approving other clinical guidelines for medical and clinical interventions under section 14A of the Act?

Q8 Do you agree the immunisation provider has discretion whether to provide immunisation when the provider is unable to convey sufficient, appropriate and reliable information in response to question 7?

Q9. Do you agree the immunisation provider has discretion whether to provide immunisation when a pregnant woman considers there is not sufficient, appropriate and reliable information in response to question 7?

Q10 Are you aware of the reasons the Handbook guidelines have decided to withdraw or omit the NHMRC mandatory guidelines, and in particular, whether this omission impacts the adequacy of the evidence base supporting the efficacy, effectiveness and safety of administration of the whooping cough and influenza vaccine drugs to pregnant women?

Q11 Are you aware of any systematic reviews, which consider the efficacy, effectiveness or safety by combining the whooping cough and influenza vaccines, in comparison to individual vaccine injections? Can the whooping cough vaccine be administered individually in Australia?

Q12 Are you aware of any systematic reviews of the whooping cough and influenza vaccines, which examines the efficacy, effectiveness or safety of those vaccines, based upon a comparison of those vaccines, with a placebo trial that excludes the adjuvants, or other ingredients specified in each vaccine?

Q13 Are you aware of any controlled studies as to the safety of the the whooping cough and influenza vaccines, in which comparison of health outcomes in vaccinated pregnant women versus unvaccinated pregnant women is documented?

Q14 (Not relevant to vaccinations during pregnancy).

Q15 (Not relevant to vaccinations during pregnancy).

Q16 (Not relevant to vaccinations during pregnancy.)

Q17 What weight do you consider reports by Cochrane Collaboration into vaccination efficacy or safety should have, in relation to other studies referred to in the Handbook, or in your presentation on 12 July 2016?

Q18 (Not relevant to vaccinations during pregnancy).

Q19 – Q31 are based upon page 3 of the Handbook, 10th ed in so far as they relate to administration of the whooping cough and influenza vaccine drugs to pregnant women.

Q19 Which are your recommendations based upon strategies in the absence of high-quality evidence?

Q20. Which are the less rigorous studies such as uncontrolled clinical trials, case series and/or other observational studies?

Q21. Which immunisation handbooks, produced by comparable countries, were also consulted by ATAGI?

Q22. Which public sources were inadequate, resulting in recommendations being based upon expert opinion?

Q23. What are the limitations and challenges to developing recommendations, which continue to exist?

Q24. What are the unaddressed scientific questions?

Q25. What are the complex medical practice issues?

Q26. What are the differences in expert opinion, and which experts were ultimately followed?

Q27. What were the conflicts of interest of those experts who were ultimately followed when resolving differences in expert opinion?

Q28. Given all these limitations, which recommendations of ATAGI were not possible to provide clear and relevant recommendations?

Q29. Are there guidelines of NHMRC older than the 1975 Ist edition of the Australian Immunisation Handbook?

Q30. How does the scope of the Handbook differ from other NHMRC guidelines?

Q31. How does the complexity of the Handbook differ from other NHMRC guidelines?

Q32. What would be the grades of evidence assigned to your recommendations for the administration of the whooping cough and influenza vaccine drugs to pregnant women.

Thank you Assoc Prof Marshall for your attention to this matter.

Yours sincerely

Graeme Little né Peter Pope

Health Politics Advocate/Lawyer

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