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Abstract
In this submission I suggest this Expert Panel recommends that:
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the Medical Board of Australia be required to change its Code of Conduct to ensure
that is clear to doctors that they are able to refuse to participate in any medical
procedure to which they have a conscientious objection, including preventatives,
an inquiry be held into the Department of Health and Ageing (DHA) vaccination
recommendations to assess whether the vaccines are necessary today for the
sectors of society for which they are recommended, given incidence rates of the
diseases, best practice low risk preventatives (eg pap smear testing for cervical
cancer) and best practice treatments that reduce the risk of harm from the disease
(eg vitamin A for measles) and to assess whether the recommendations for people of
different ages and lifestyles are consistent and logical,
in order to obtain informed consent vaccine providers (nurses, doctors) be required to
inform parents that the cumulative impact of the vaccines on the current Childhood
Immunisation Schedule has never been assessed,
the DHA be required to commission a retrospective cohort study to compare the
health of fully vaccinated and unvaccinated children and that no new vaccines are
added to the Childhood Immunisation Schedule until this study is completed and only
then if it demonstrates that there is no difference in the health of the two cohorts,
the Australian Technical Advisory Group on Immunisation (ATAGI) be required to
appoint as voting members only people with no potential conflicts of interest, that
these new members commission and approve a new publication to replace those
currently provided by the DHA for patients that contains the necessary information to
enable patients to give informed consent for vaccination, and that these new
members define a mandatory set of best practice pre-licensing safety testing
procedures against which all new and existing vaccines must be assessed,
the Therapeutic Goods Administration (TGA) be required to issue regular reports on
the status of its pharmacovigilance knowledge on individual medicines, eg vaccines,
that the public be allowed to submit evidence of harm of medicines to other people to
the TGA and that the TGA be required to explain what the trigger levels are for
withdrawal of different categories of drugs, eg anti-inflammatories versus vaccines,
the Advisory Committee on the Safety of Vaccines be required to commission
research to answer questions about the safety of vaccines submitted to it by
members of the public if the TGA or DHA have not asked those questions,
advertising of medicines to the general public not be allowed and that implementation
of the current regulations be strengthened given that television advertisements for
vaccines have been shown on free-to-air television recently,
Members of Parliament are prevented from overruling decisions made by
Pharmaceutical Benefits Advisory Committee or other independent organisations
involved in the approval of medicines but be allowed instead to call for a review of the
decision if they believe that an unsafe decision has been made,
conscientious objector forms be no longer required, and
an inquiry be held into the actions of ATAGI on the Fluvax vaccine and that the DHA
and TGA be required to explain why they accepted and supported the ATAGI Fluvax
recommendations.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
2
CONTENTS
page
ABSTRACT
Introduction
Ideas on Chapter Three: principles underpinning this review
Ideas on Chapter One: Terms of Reference, points 7 a and 7 f
Ideas on Chapter Four: regulation of prescription medicine
Ideas on Chapter Eight: Framework for advertising therapeutic goods
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Introduction
I am an Australian citizen, a member of the public. I represent no organisations. My
interest in regulation of medicines began when I asked a doctor ‘why do you recommend
the hepatitis b vaccine for newborn babies?’ The doctor replied ‘if I didn’t I would be
deregistered’.
I thank the Minister for enabling members of the public to contribute ideas to this Review.
Ideas on Chapter Three: principles underpinning the review
This Expert Panel has identified a number of core principles which it believes should
underpin the Review and provide a lens through which issues and options can be viewed.
Question for consideration:
Are there any additional principles that should be considered?
I suggest an additional Principle be included and adhered to by all levels of government:
Protection of public health does not take precedence over the right of patients
to accept only necessary, safe and effective medicines or the right of patients
to give informed consent when accepting medical procedures or the right of all
people to free speech.
If all doctors were able to respond honestly to patients’ questions about vaccines Australia
would be better able to respond to the global trend in development of new vaccines. All
doctors in Australia must comply with the Code of Conduct issued by the Medical Board of
Australia (MBA). It is part of the regulatory framework for medicines because it governs how
doctors recommend medicines. Failure to comply with the Code of Conduct can lead to a
doctor being deregistered. The Australian Medical Association (AMA) has stated that the
Code is ‘legally binding’.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
3
Free speech is a fundamental human right for all people, including doctors. Some doctors
are denied this right due to the wording of the Code of Conduct which leads those doctors to
believe that they will be deregistered if they do not fully support the Department of Health
and Ageing (DHA) recommendations on vaccination. This belief leads those doctors who
disagree with the recommendations to encourage their patients to accept vaccines that they
do not think are necessary, that they believe may cause the patient harm.
Patients have a right to give informed consent for medical procedures, including vaccination.
Doctors should be able to discuss with their patients any information on any aspect of
vaccination that they believe is important from any source they believe is reliable even if it
contradicts the views of the DHA without fear of deregistration. Doctors who believe that if
they disagree with the recommendations of the DHA they will be deregistered do not give
their patients information that does not support the DHA position, they do not tell their
patients they are not expressing their individual professional opinion on vaccination, thus
they deny their patients the opportunity to give informed consent.
There are a words commonly used in medicine that have distinct meanings and are not
interchangeable. ‘Procedure’ means a series of steps taken to accomplish an end.
‘Treatment’ means the application of remedies for a disease that a person has developed or
an injury they have received. ‘Preventative’ or prophylactic means measures to protect a
person from a disease to which he or she may later be exposed or a condition he or she may
later develop. Treatments are given to people who are already ill or injured. Preventatives
are given to people who are healthy to reduce the likelihood of their becoming ill. These
meanings are clear and indisputable, are they not? Can we expect the MBA to use these
words appropriately in a legally binding Code of Conduct?
By writing ‘Being aware of your right to not provide or directly participate in treatments to
which you conscientiously object’ in Code 2.4.6 the MBA prevents a doctor from refusing to
participate in a medical procedure to which he or she conscientiously objects if that
procedure does not involve treatment of disease or injury. Doctors interpret this statement
accurately when they think it means that they must support and participate in preventative
procedures such as vaccination, that if they did not they could be deregistered.
I suggest that this Expert Panel recommend that:
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the MBA be required to revise its Code of Conduct and replace the word
‘treatments’ in Code 2.4.6 with the word ‘procedures’. As it was surely not the
intention of the MBA to deny both doctors and patients their fundamental
human rights the MBA should have no objection to making this alteration.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
4
There is another statement in the MBA Code of Conduct that also leads doctors to believe
that they must support the DHA recommendations on vaccination, Code 5.4.2: ‘Participating
in efforts to promote the health of the community and being aware of your obligations in
disease prevention, screening and reporting notifiable diseases.’ Nowhere in the Code of
Conduct are these obligations explained. How can a doctor comply with obligations without
knowing what they are? This is a legally binding Code of Conduct which applies to every
doctor in Australia. Is it acceptable for this Code of Conduct to include unexplained
obligations? Doctors who disagree with the DHA recommendations on vaccination but who
wish to safeguard their career interpret this as a requirement that they must support those
recommendations.
I suggest this Expert Panel recommend that:
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the MBA be required to change the wording of Code 5.4.6 by deleting ‘being
aware of your obligations in disease prevention’.
The introduction to the Code of Conduct includes the following statements. ‘This code is not
a substitute for the provisions of legislation and case law. If there is any conflict between
this code and the law, the law takes precedence.’ It should not be the responsibility of every
doctor, individually, to seek advice from lawyers on whether legislation or case law, or
indeed human rights which the Australian government supports, conflict with the Code of
Conduct. The MBA has sufficient resources to ensure that the Code of Conduct does not
conflict with the law or fundamental human rights.
I suggest this Expert Panel recommends that:
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the MBA be required to submit this Code of Conduct to independent lawyers
(ie not individuals who work for organisations which receive income from
pharmaceutical companies or public institutions related to health care) who
have expertise in drafting professional contracts to ensure that there are no
statements in it that could lead a doctor to infer that they have obligations that
are in fact contradicted by legislation, case law or human rights.
I would like the Expert Panel to note that the AMA appears to share my point of view but it
appears not to have requested that the MBA change its Code of Conduct. An AMA policy
document on Conscientious Objection (dated 28th November 2013) states:
Point One: Doctors (medical practitioners) are entitled to have their own beliefs and
values, as are all members of society. There may be times, however, where a
doctor’s personal beliefs conflict with their peer-based professional practice. In
exceptional circumstances, and as a last resort, a doctor may refuse to provide or
participate in certain medical treatments or procedures that conflict with his or her
own personal beliefs.
Point Seven: A doctor who has a conscientious objection should not be treated
unfairly or discriminated against.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
5
The AMA Code of Ethics (2004, revised 2006) includes the following points:
Section 3: Professional Independence.
Point one: In order to provide high quality healthcare, you must safeguard clinical
independence and professional integrity from increased demands of society, third
parties, individual patients and governments.
Point four: Recognise your right to refuse to carry out services which you consider
to be professionally unethical, against your moral convictions, imposed on you for
either administrative reasons or for financial gain or which you consider are not in the
best interest of the patient.
Section 4: the doctor and society.
Point six: When providing scientific information to the public, recognise a
responsibility to give the generally held opinions of the profession in a form that is
readily understood. When presenting a personal opinion which is contrary to the
generally held opinion of the profession, indicate that this is the case.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
6
Ideas on Chapter One: Terms of Reference, points 7 a and 7 f
It is stated in the Review of Medicines and Medical Devices Regulation discussion paper that
stakeholders are welcome to bring to the Panel’s attention other issues that fall within the
Review’s Terms of Reference. There are two points in the Terms of Reference that I
address here as it is stated in the discussion paper that the Review will make
recommendations and provide related implementation information on them:
7a. Ensure there is an appropriate balance between risk and benefit in the regulation
of prescription, over-the-counter, complementary medicines and medical devices, as
well as access for individuals to unapproved medicines and medical devices;
7f. Any other matters that the review committee regards as important and relevant to
the safe and efficient supply of effective medicines and medical devices to the
Australian people.
The Department of Health and Ageing recommendations on vaccination
A matter that is relevant to the safe and efficient supply of effective medicines in Australia is
whether it is a rational decision if a doctor supports the vaccine recommendations made by
the Department of Health and Ageing (DHA). This is obviously important to patients and it is
important to doctors if they wish to avoid medical negligence lawsuits.
Please consider this scenario. A wealthy celebrity, with access to the media, agrees to have
their child vaccinated according to the recommended schedule on the advice of their general
practice doctor. Their child reacts badly to vaccines as a baby and as a toddler develops
autism, with symptoms first occurring and then worsening after each visit to their doctor for
vaccination. The parent starts investigating the link between autism and vaccines (which
their doctor had dismissed when they raised it) and finds that there are many, many scientific
reports published in peer reviewed journals linking vaccines to autism. They then find that
courts in Italy and the USA have found in favour of parents who claimed their child had
developed autism due to being vaccinated. Whereas financial compensation for their child
may not be important, the wealthy parent might be prompted to go to court to achieve justice
for their child and to publicise this issue to inform other parents about what they have
learned.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
7
If a person injured by vaccines, or a parent of a child injured by vaccines, took their doctor to
court and argued that their doctor, by supporting the DHA vaccine recommendations, acted
negligently the doctor would most likely claim in their defence that supporting the DHA
recommendations is widely accepted as competent professional practice, which means that
they would not incur a liability in negligence. There is a statutory definition in medical
negligence law in all States and Territories which enables a person practising in a profession
to avoid incurring a liability in negligence if it is established that the professional acted in a
manner that at the time the service was provided was widely accepted in Australia by peer
professional opinion as competent professional practice. Peer professional opinion
cannot, however, be relied on if the court considers that the opinion is irrational
(‘unreasonable’ in Victoria and Western Australia).
I see many inconsistencies when I compare the DHA vaccine recommendations for children
and for adults for diseases that very few people in Australia actually catch, diseases that can
be caught and passed on by people of any age, diseases that can cause rare complications
in people of any age, not only in children. I wonder, would a judge in a medical negligence
law suit consider that doctors are thinking rationally when they support the DHA vaccine
recommendations?
I suggest this Expert Panel recommends that an inquiry be held into the DHA vaccination
recommendations. Here are some questions that should be addressed.
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Are all the vaccines recommended today necessary today for the sectors of
society for which they are recommended given the incidence rates of the
diseases, best practice modern preventatives (eg the pap smear to prevent
cervical cancer) and best practice treatment methods for people who catch the
diseases (eg vitamin A for people with measles)?
Have all the vaccines recommended for use today been demonstrated to be
effective using modern best practice assessment techniques? Are they
effective against the strains of virus that are circulating in Australia today?
Have all the vaccines recommended for use today been tested for safety to
best practice standards?
Are the recommendations for different ages and sectors of society consistent,
logical and rational?
To support this recommendation I would like to draw the attention of this Expert Panel to
some basic facts about the diseases, incidence rates of these diseases in Australia,
treatment options and the current DHA vaccination recommendations.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
8
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It is a fact that herd immunity cannot be achieved through high levels of vaccination
in children. It is a fact that individuals can respond well, partially or poorly to
vaccines. It is a fact that vaccines provide a maximum of five – twenty years
protection to people who respond well to vaccines (some vaccines are longer lasting
than others). It is a fact that vaccines provide only partial protection during this
period when given to average vaccine responders. It is a fact that vaccines provide
no protection at all when given to poor vaccine responders. When a poor vaccine
responder is exposed to the disease after they have been vaccinated the poor
responder, just like an unvaccinated person, will catch the disease and have all the
typical symptoms. They will know they have caught the disease and can be
quarantined. When an average vaccine responder is exposed to a disease after
being vaccinated they may catch the disease but may not get all the typical
symptoms, so they benefit by not suffering so much. But as they don’t get all the
typical symptoms they may not realise they have caught the disease and may carry
on with normal life and may unintentionally infect many other people. How do these
facts affect the goal of herd immunity and DHA policy on vaccination? It is a fact that
unless adults get regular booster shots until they die and are good responders, they
are not fully protected against the diseases children are vaccinated against. So the
majority of our human herd (maybe 70%) will be unprotected against these diseases
even if 100% of children are vaccinated because most adults do not get regular
booster shots and many people are average or poor responders. (And obviously
children also will be good, average or poor responders, so if every child were
vaccinated some children would still catch and pass on the disease.)
The hepatitis B vaccine is recommended for all newborn babies and for adults ‘with
increased risk of exposure’ such as prostitutes, men who have anal sex and
intravenous drug users because it is passed by exchange of body fluids. Babies
could only conceivably be at risk if a primary carer has Hep B. All pregnant women
are tested for Hep B. Fewer than five babies contract Hep B every year, most likely
during birth from their mothers who already carry the disease. The vaccine will not
protect these children from contracting the disease. How does the DHA justify
recommending this vaccine for every newborn baby but not for every adult?
The diphtheria vaccine is recommended for all children and booster shots are
recommended for all adults every ten years. How many adults get booster shots
every ten years? In the last 20 years ONE person in Australia has had diphtheria.
Given the incredible rarity of this disease in our unprotected adult population how
does the DHA justify these recommendations?
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
9
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The tetanus vaccine is recommended for all children and every ten years for adults
over fifty. It is not recommended for younger adults because younger adults are not
at risk not because the vaccine is effective for fifty years. Tetanus is not contagious
and only those with very poor blood circulation are at risk. 2-5 people develop it each
year when the bacteria infect wounds in tissue that receives no oxygen. The vaccine
has been used for many decades and has not been tested for efficacy and safety to
modern standards. It is argued that it is unethical to test it because some test
participants would have to go without the vaccine and take instead a placebo. Why
does the DHA consider it ethical to recommend a vaccine with known risks of severe
side effects and no modern proof of safety or efficacy for people of all ages when
they receive a wound in oxygenated tissue that can be easily and thoroughly
cleaned? Why does the DHA consider it ethical to recommend a vaccine with no
modern proof of safety or efficacy and known severe side effects for babies, 50 years
before they are likely to be at risk? (Newborn babies in developing countries die
when tetanus bacteria infect their umbilical cord. As moderate levels of hygiene
prevent this, newborn babies in Australia do not contract tetanus.)
The pertussis vaccine is recommended for all children and for adults ‘who wish to
reduce the likelihood of becoming ill’. Is this a euphemism for ‘the vaccine won’t stop
you catching and passing on the virus, but it will reduce the severity of your
symptoms’? Because that is how the pertussis vaccine works. The vaccine is also
recommended for ‘people in contact with young infants’. So it appears that the DHA
believes it is acceptable for children and adults who have contact with infants to
catch the disease and pass it on to infants without even realising they have it
(because their symptoms are mild). As the vaccine is not recommended for every
adult it appears that the DHA believes that it is acceptable for adults who have no
children or only older children to catch and pass on the disease. And it has been
reported that that the vaccine currently in use in Australia is ineffective against the
most common strain circulating in Australia. How does the DHA justify its
recommendations?
The haemophilus influenza type B (Hib) vaccine is recommended for children
only. There are many strains of haemophilus influenza, pneumococcal and
meningococcal bacteria that can cause invasive disease. These bacteria live in
many people (eg Hi bacteria are found in over 90% of people) without causing harm
and no one knows why they become invasive in some people (of any age), who may
have carried the bacteria for a long time without ill effect. Approximately 20 cases of
invasive bacterial disease are caused by Hib each year. How many cases of
invasive disease occur due to Hi types a, c, d, e and f which are not covered by the
vaccine I wonder? Why does DHA believe that children should be vaccinated
against a couple of strains of very common and normally harmless bacteria and left
unprotected against the vast majority of equally common and normally harmless
bacteria while it believes that adults can remain unprotected?
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
10
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The polio vaccine is recommended for all children and for adults every ten years
only if they are likely to come into contact with polio. Only ONE person is known to
have come to Australia with polio in the last 30 years and he didn’t infect anyone
living here. Polio is passed through consumption of faeces. 99% of people with polio
have no or only minor symptoms and the only serious complication, ‘acute flaccid
paralysis’, can occur at any age (and it is a complication of many other diseases, not
only polio). Why does the DHA believe it’s acceptable for adults to live in Australia
without vaccine protection against polio when it recommends that all children, who
are at no greater risk of harm, be vaccinated?
The rotavirus vaccine is recommended for all children but not for adults.
Rotaviruses cause gastroenteritis, as do many other viruses, bacteria, parasites and
chemicals, which all affect people of all ages. The only serious complication is
dehydration and young children are at greater risk as they can’t say ‘I’m thirsty’. Why
does the DHA recommend children be protected by a vaccine against just one of
many causes of gastroenteritis induced dehydration? Why does the DHA not focus
instead on educating parents on the importance of rehydration and how to manage
dehydration which would protect children against the only serious complication from
ALL episodes of gastroenteritis?
The measles vaccine is recommended for all children and for adults who work in
health or with children. So the DHA must believe it is acceptable for adults who don’t
work in health or with children to catch and pass on the disease to people of all ages.
That is actually rational, because most people suffer only a few days of fever, rash
and flu like symptoms and complications are rare, it has been proven that they are
often caused by vitamin A deficiency and can be prevented by treatment with vitamin
A. And of course actually having the disease gives you lifelong immunity and some
scientists believe that catching measles gives a person protection against other more
harmful diseases. But why if the DHA, totally rationally, believes that it acceptable for
adults to catch and pass on measles to people of any age does it recommend the
vaccine for all children?
The mumps vaccine is recommended only for children. Mumps is usually a mild
disease but can cause rare complications at any age and in particular in adult men
and pregnant women. Outbreaks of mumps occur in young adults who have been
vaccinated as children. Approximately 280 people are diagnosed with mumps in
Australia every year. Merck has apparently been accused recently by whistleblowers
of suppressing clinical trial data that shows that their mumps vaccine is not as
effective as they claim. But regardless of efficacy, we are all at greater risk from
mumps post-puberty so why does the DHA only recommend this vaccine only for
children?
The rubella vaccine is recommended for all children but only for adult women of child
bearing age. It is a mild disease and only causes significant harm to unborn babies.
The only justification the DHA could have that I can see for recommending this
vaccine for children is to protect pregnant women they might encounter, that is
pregnant women who themselves have refused to take the vaccine and who could
catch the disease from any unvaccinated adult they encounter. How does the DHA
justify recommending this vaccine for all children but not for all adults?
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
11
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The chicken pox vaccine is recommended for all children and for adults who are not
immune. Chicken pox is a mild disease in children and much more severe in adults.
Having chicken pox as a child and then having contact with people with chicken pox
as an adult protects you against the more painful and dangerous condition shingles.
Approximately 5 people die every year from chicken pox in Australia (nearly all over
60) and about 15 die from shingles. Approximately 4,000 people are hospitalised
with shingles every year, this is increasing, and the increase was a predicted
consequence of introducing the chicken pox vaccine. So it appears that the DHA
believes that children should be vaccinated against chicken pox despite the fact this
puts them at greater risk of harm from chicken pox if they catch it as an adult after
the vaccine’s protective effects have worn off AND at greater risk of harm from
shingles if they don’t catch chickenpox. How does the DHA justify these
recommendations?
The HPV vaccine is recommended only for girls and boys 12-13 years old. Given that
cervical cancer is already effectively controlled by the 100% safe pap smear test,
which vaccinated girls must still have, the DHA’s goal must be to reduce the spread
of a few strains of HPV virus through sex. The DHA states that those who receive the
vaccine prior to being sexually active will receive ‘most benefit’. Older Australians
who are not already infected with the few strains of HPV covered by the vaccine
would derive the same level of benefit. How does the DHA justify not recommending
this vaccine to adults?
Assessing the safety of using multiple vaccines
I don’t imagine that an oncologist would recommend a dozen different chemotherapy drugs
to be used in combination by one patient over a period of a few years if that doctor had no
knowledge about interactions between the drugs and the possibility of a cumulative harmful
effect from the combination. The DHA recommends multiple doses of multiple vaccines for
children to be taken before four years of age. The DHA has no evidence that the full set of
vaccines it recommends do not interact, it has no evidence that cumulatively these vaccines
do not cause harm to some individuals. It would enhance the regulatory framework for
medicines if the DHA were prevented from recommending multiple medicines to patients
when it has no knowledge on whether in combination they cause harm to some individuals.
I suggest that this Expert Panel recommends that:
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the DHA be prevented from making recommendations (or accepting
recommendations made by organisations or committees appointed to make
them) about use of medicines such as vaccines which the DHA knows are
used in combination within a period of a few years and which the DHA
recommends be used in combination over a period of a few years, if it does
not have scientific evidence that demonstrates that in combination over that
time period these medicines do not cause harm.
Given that the cumulative effect of all the vaccines on the DHA’s current Childhood
Immunisation Schedule has never been investigated I suggest that this Expert Panel
recommends that:
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
12
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to obtain informed consent from parents the DHA requires all vaccine
providers (GPs, nurses etc) to ensure that parents are informed that the
cumulative effect of the vaccines on the current Childhood Immunisation
Schedule has never been investigated, that this point be clearly made on
consent forms and that parents be required to sign a statement confirming
they understand this,
the DHA commission a retrospective cohort study to compare the health of
fully vaccinated and unvaccinated children and to allow any interested member
of the public to comment on and have input to the design of the study before it
is commenced. As the vaccination records of all children in Australia have
been collected by the Department since 1996 identifying appropriate
individuals would be straightforward. No child would be put at risk of harm
from participation in the study because it would involve comparison of doctordiagnosed medical conditions (eg juvenile diabetes, asthma, food allergies)
and neurological/behavioural conditions (eg autism spectrum disorder).
no new vaccines are added to the Childhood Immunisation Schedule until a
retrospective cohort study is completed and only then if the study
demonstrates that there is no difference in the health of the two cohorts of
children.
Managing conflict of interest
There are numerous organisations and committees involved in the process of approving,
promoting and researching vaccine use in Australia. It would enhance the regulatory
framework of medicines if members with voting rights on important committees had no
conflicts of interest. The DHA acknowledges there is a risk of conflict of interest because:
‘There is a small pool of experts in immunology from which to choose members (of the
Australian Technical Advisory Group on Immunisation, ATAGI) and members can at times
have real or potential conflicts related to a particular vaccine or pharmaceutical company.’
(Quote from a letter written to me by Joel Willis, Director, Immunisation Programs Section,
Department of Health, February 2014). ‘All potential conflicts are recorded and managed
within strict protocols’ he informed me.
The DHA’s ‘strict protocols’ on conflict of interest apparently enabled the Chair and Deputy
Chair of ATAGI to be involved in the discussions on approval of the CSL Fluvax trivalent
influenza vaccine in 2002 despite their both being involved in testing the vaccine. Can we
conclude that the DHA’s ‘strict protocols’ are effective and effectively implemented given that
ATAGI approved use of the CSL Fluvax in 2002 in children over six months old even though
NO controlled clinical studies had been conducted in children by then and even though it
was well known by then that children and adults respond differently to vaccines?
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
13
Isn’t it true that pharmaceutical companies risk fines of billions of dollars if they promote ‘offlabel’ use of medicines? What are the consequences when a committee approves use of a
medicine in a sector of society in which it has never been tested? What are the
consequences when the DHA recommends and actively encourages use of a medicine by a
sector of society for which it has been approved despite the fact it has never been tested for
safety in that sector?
Joel Willis stated that it is also ATAGI’s role to ‘provide advice to research funding bodies
regarding the status of current immunisation research and areas where additional research
is required and to advise the Pharmaceutical Benefits Advisory Committee on matters
relating to the ongoing strength of evidence pertaining to existing, new and emerging
vaccines’. It has been reported that clinical trials of Fluvax were carried out in children
THREE years after the vaccine was approved for use in children (in 2005-6) and the results
of this study were published SIX years after the vaccine was approved for use in children (in
2009). This study revealed there was a marked difference in the risk of fever in children
depending on the annual formulation of the vaccine. In 2009/10 there were 6290 adverse
reactions to this vaccine in children under seven years old reported to the government
including thousands of cases of seizure and four deaths.
I suggest that this expert panel recommend that:
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an inquiry be held into the actions of ATAGI on the Fluvax vaccine and that
ATAGI be required to explain how the ‘strict protocols’ governing conflict of
interest were implemented during the discussions, on what basis it justified
approval of use of the vaccine in children, what action it took to advise
funding bodies about the fact that it had not been tested in children and what
advice it gave to PBAC on the strength of evidence that it was safe for use in
children and
the DHA and TGA be required to explain why they accepted the ATAGI
recommendation in 2002 that Fluvax could be taken by a babies over six
months old and why they promoted use of the vaccine by babies despite the
lack of evidence on the vaccine’s safety.
Given that the DHA acknowledges that there is a small pool of experts in immunology and
these individuals can have conflicts of interest and it can only manage those conflicts, not
avoid them, I suggest that this Expert Panel recommends that:


ATAGI be required to appoint individuals as voting members only if they do not
have a conflict of interest. They could be practicing doctors who are not
involved in clinical trials funded by pharmaceutical companies or by any public
health organisations (doctors would only have no conflict of interest if the
MBA Code of Conduct is changed in the way I recommend above) and
the small pool of experts in immunology who ‘have real or potential conflicts’
of interest be allowed only to submit opinions and evidence to ATAGI.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
14
A newer organisation is the Advisory Committee on the Safety of Vaccines (ACSOV). Its
purpose is ‘to provide advice to the TGA and the Office of Health Protection (OHP) on,
among other things, matters relating to the safety, risk assessment and risk management of
vaccines supplied in Australia.’ Their ‘meeting statements’ begin with similar sentences
which indicate that the Committee only responds to questions it is asked, eg ‘At this meeting,
the comittee’s advice was sought on ...’ (March 2014), ‘The committee was asked to provide
advice on...’ (October 2013) ‘The committee was asked to provide advice relating to...’ (May
2013) ‘. It appears that ACSOV cannot give answers to questions that the TGA and OHP
have not asked.
I suggest that this Expert Panel recommends that:

ACSOV be required to answer questions submitted to it by members of the
public. If these questions have already been answered ACSOV would be able
to provide a reference to the relevant document that contains the answer. If a
member of the public thinks of an important question about the safety of
vaccines that the TGA and OHP have not asked, for example: could there be a
risk of a cumulative harmful effect on a child if he/she receives multiple doses
of multiple vaccines in the first four years of life (eg the 40 or so recommended
by the DHA)? and ACSOV cannot find an answer to it, ACSOV should be able
to commission the necessary research to find the answer.
Obtaining informing consent from parents on the need for, and risks associated with,
vaccines recommended for their children
Doctors have an obligation to obtain informed consent from patients. Informed consent
essentially means providing the information that a ‘reasonable person’ would want to know.
Patients are offered vaccines when they are healthy. Patients may never encounter the
disease the vaccine is designed to protect them against. They may not suffer serious harm
even if they do catch the disease and only catching the disease offers them life-long
immunity.
As the DHA undoubtedly supports a patient’s right to give informed consent I believe that the
DHA should provide all the information a reasonable person would want to know when
explaining the pros and cons of vaccination. The most comprehensive document for
doctors, nurses and patients on vaccination provided by the DHA is ‘Myths and realities –
responding to arguments against vaccination – a guide for providors’. (Three of the four
authors of this document work for the National Centre for Immunisation Research and
Surveillance, the primary goal of NCIRS is ‘research aimed at reducing incidence of vaccine
preventable disease and improving vaccine uptake’.) This document states, under the
heading ‘Vaccines weaken or overwhelm the immune system’, the view of the DHA on the
fundamental question of whether there could be a cumulative harmful impact from receiving
multiple vaccines as follows.
‘Vaccines only contain a small number of antigens in comparison to what children
encounter every day in their environment, through routine eating, drinking and playing,
and they do not overwhelm or ‘use up’ the immune system.’
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
15
It is true that a child is exposed to many more antigens in their environment through routine
eating, drinking and playing, than are included in vaccines. Antigens a child is exposed to in
routine eating, drinking and playing are ingested or inhaled or absorbed through the skin,
thus are dealt with by the body’s entire immune system the way nature intended. Nearly all
vaccines are injected, which obviously bypasses major components of the body’s immune
system and the antigens in vaccines are injected together with multiple chemicals many of
which are known to be toxic. How does the Department justify ignoring these points? How
does the DHA explanation enable a parent to give informed consent?
This DHA document goes on to state:
‘If giving multiple vaccines overwhelmed the immune system, then one might expect
much lesser immune responses when many vaccines are given at the same time
compared with when they are given at different times.’
As the DHA supports patients right to give informed consent, can the DHA explain why it
addresses the question of the number of vaccines given on one occasion but does not
address the fact that multiple doses of vaccine are given at the same time and then again a
few months later and then again a few months later and so on? And can the DHA explain
why it has not acknowledged that many medical experts, who do not ignore the fact that
multiple vaccine doses are given on multiple occasions, believe that receiving multiple
vaccines could cause the immune system of some children to malfunction for example by
over-reacting to external threats and creating ‘allergies’ or by attacking the child’s body and
creating auto-immune disease?
This DHA document goes on to state:
‘However, when vaccines are developed, they are studied to confirm that the addition of
a new vaccine (and the existing vaccines given at the same time) still have the same
immune response and safety profile.’
As the DHA supports patients right to give informed consent can it explain why it chose not
to mention that multiple vaccines used in combination on one day are not tested in
combination with the multiple vaccines given to the child in the months before and after?
And can the DHA explain why it did not make it clear that in this statement that it is ONLY
referring to vaccines combined in one vial, given in one injection? Can the DHA explain why
it did not make it clear that if a single multi-vaccine injection is given on the same day as
several other individual vaccine injections and oral vaccines that the combined effect of the
full set of vaccines given on that day has not been tested?
I suggest that this Expert Panel recommends that:

the above mentioned ATAGI committee of doctors whose regular employment
involves contact with patients and who have no conflict of interest (see conflict
of interest recommendation) be responsible for final approval of all information
provided by the DHA to vaccine providers and patients and be responsible for
ensuring that these documents contain the information a reasonable person
would want to know in order to be able to give informed consent and
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
16

to enable patients to give informed consent on vaccination the DHA
commission a new document (to be approved by the new ATAGI committee
members) which provides patients with information on every vaccine which
would include:
 a description of the nature of the disease, how it is transmitted (eg faecal-oral
route), which sectors of society are at risk and why they are at risk (eg due to
age, health or lifestyle), a description of the typical course of the disease in
healthy individuals, what is the best practice treatment for the disease in
healthy individuals and whether conventional nutritional supplements (eg
vitamins) or other actions (eg bed rest, adequate hydration) can prevent
complications and aid recovery, an explanation of which individuals are likely
to suffer complications and why (eg can complications occur in a healthy
individual or do they typically only occur in unhealthy individuals who have a
suppressed immune system or have other issues such as malnutrition,
chronic drug or alcohol abuse?) a description of the complications and how
common they are, best practice treatment of complications and likely
outcomes,
 the proportion of people in Australia who currently have no vaccine protection
from the disease, that is the proportion who have never been vaccinated plus
the proportion in whom vaccine protection is partial or non-existent due to
their being poor responders to vaccines plus the proportion in whom vaccine
protection has expired because they have not received booster shots within
the recommended time frame,
 the incidence rate of the disease in Australia in adults and children in recently
vaccinated people (ie within the time frame that it is expected to provide
protection) and in people who have no vaccine protection through not being
vaccinated or not having received booster shots according to the
recommended schedule,
 the effectiveness of the vaccine, that is the proportion of strains of the virus
currently circulating in Australia that it covers, the nature of the benefit (eg
does the vaccine prevent the person from catching the disease or does it
merely reduce the severity of their symptoms?), the duration of the benefit (in
those individuals who respond well to the vaccine for how many years will it
provide a beneficial effect?), the proportion of individuals who are likely to be
partial or non-responders to the vaccine and therefore derive little or no
benefit,
 whether the vaccine recommendations for adults and children are consistent
and if not, why not
 whether there are any limitations in the understanding of the safety of vaccine
(eg has it been tested in all the sectors of society for whom it has been
approved? Were true placebos used?)
 what knowledge there is on adverse effects (eg how many adverse effects
were identified in clinical trials against a true placebo and how many adverse
effects have been reported in Australia and elsewhere, how many of those
were serious?)
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
17

that this document should be regularly reviewed and updated to respond to
emergence of new virus strains for which existing vaccines offer no protection
or new treatment options or other relevant facts.
Involvement of politicians in the approval process for vaccines
In 2006 Prime Minister Howard overruled the Pharmaceutical Benefits Advisory Committee
decision not to include the HPV vaccine on the national immunisation programme. This is
the only time an Australian Prime Minister has overruled a decision made by the
‘independent’ PBAC.
I suggest that this Expert Panel recommends that:


Members of Parliament are prevented from overruling decisions made by
PBAC and other independent committees and organisations involved in the
approval of medicines and medicinal devices and
in the interests of full accountability and to prevent inappropriate decisions
being made, when Members of Parliament believe that the wrong decision has
been reached by such a committee or organisation a process is established to
enable that decision to be openly reviewed to enable critics views to be heard
and responded to before a final decision is made.
Use of conscientious objection forms
An adult is not required to sign a conscientious objection form and to find a doctor willing to
counter sign it if they chose not to accept a vaccine recommended by the DHA and wish to
receive the tax benefits their financial circumstances entitle them to. Yet parents who
choose not to accept vaccines on behalf of their children are required to sign a conscientious
objection form and find a doctor willing to counter sign it in order to receive the tax benefits
their financial circumstances entitle them to and to enable their child to attend a day care
centre or family day care. The AMA has informed doctors they are not obliged to sign the
form. Whether or not these forms are signed and counter signed the government keeps
records on which vaccines have been administered to every child, so the only benefit of the
form to the government is that ensures that the parent has found a doctor willing to sign it.
I suggest this Expert Panel recommends that:

conscientious objection forms be no longer required.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
18
Ideas on Chapter Four: regulation of prescription medicine
Questions for consideration:
What options are available for determining ‘trusted overseas regulators’?
If a criteria based approach were to be adopted, what criteria should apply in
determining whether or not an overseas regulator is trusted?
All the questions for consideration in this chapter are based on the assumption that a ‘trusted
overseas regulator’ could exist. With regard to vaccines I don’t know whether there is a
‘trusted overseas regulator’ but I believe that there is sufficient evidence to show that
regulators in the USA should not be considered ‘trusted overseas regulators’ with regard to
vaccines.
The important issue for the Australian public with regard to vaccines is whether they are
licensed without adequate safety assessments not that there is unnecessary red tape and a
costly, slow approval process.
Here are some points from an article written by Richard Gale and Gary Null: ‘Are vaccines
safe?’ (it can be found on the website globalresearch.ca Sept 2, 2014) which illustrate why
Australia should not regard regulators in the USA (nor in the UK) as trusted, with respect to
vaccines.
There are no long-term double-blind, controlled placebo studies for any of the
pharmaceutical industry’s vaccines nor are there any studies to determine what interactions
might occur. In the USA:



Clinical trials with at-risk individuals, including infants, small children, pregnant
mothers and people over 65 of age are not mandatory for regulatory approval of
vaccines. The vaccine manufacturers only make predictions for these groups based
on past experience and mathematical models.
In the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and
Research’s document “Guidance for Industry: Clinical Data Needed to Support the
Licensure of Seasonal Inactivated Influenza Vaccines’, the requirements are noncommital: eg “the protocol should include a clinic visit or telephone contact at least
six months post-vaccination to ascertain serious adverse events.” and “we
recommend that you assess the safety of your investigational vaccine in several
thousand subjects.” and “we assume that approval for use in the adult population,
including the geriatric population, would be sought with the initial application.” and
“For vaccines using novel manufacturing processes and/or adjuvants, laboratory
safety tests including hematologic and clinical chemistry evaluations, may be
needed pre- and post-vaccination in the first clinical studies.”
There are no requirements before FDA approval and licensing that a vaccine
undergoes independent studies by researchers with no vested financial interests and
industry ties in order to validate a vaccine maker’s claims.
In the UK there is ‘no transparent process for evaluating the effectiveness or cost
effectiveness of vaccines.’
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
19
In the USA none of the National Institute of Allergy and Infectious Diseases (NIAID) studies
to test safety of the H1N1 flu vaccine will investigate or measure any criteria associated with
other vaccine ingredients—thimerosal (ethylmercury), adjuvants such as squalene,
formaldehyde and oxtocinol (a detergent used as a spermatocide). Individuals with known
allergies to formaldehyde, gelatin, chicken eggs or oxtocinol are excluded from the studies.
(How many patients, do you think, are actually asked whether they are allergic to these
ingredients before they get a vaccine?) In the pregnancy study (of only 120 women) women
are removed from the study if their temperature rises to 100 degrees or higher during the
first 72 hours after injection. As these women who have an immediate reaction are
deliberately excluded any longer term adverse reaction they may have will not be
discovered.
All vaccines contain multiple ingredients of known toxicity and children receiving multiple
doses on multiple occasions will receive potentially toxic quantities of these ingredients. So
with regard to the common vaccine ingredient aluminium, can the regulators in the USA be
regarded as ‘trusted regulators’? In articles on vaccine ingredients (eg askdrsears.com) an
analysis of the US regulations on aluminium is presented which show that the regulators in
the USA allow vaccines to contain potentially toxic levels of aluminium without
manufacturers being required to put warning labels on the packaging, despite the fact that
warning labels are required for other medicines that include potentially toxic levels of
aluminium. In summary, these articles state:
The FDA recommends that the maximum amount of aluminum given to a person
intravenously per kg of weight does not exceed 5mcg. Anything that has more than 25 mcg
of aluminum is supposed to have a label on it warning about the known toxicity of aluminium.
Vaccines are not required to have the warning label. Here are the maximum levels of
aluminium that can be safely injected by body weight, according to the FDA
recommendation.






8 pound, healthy baby: 18.16 mcg of aluminum
15 pound, healthy baby: 34.05 mcg of aluminum
30 pound, healthy toddler: 68.1 mcg of aluminum
50 pound, healthy child: 113 mcg of aluminum
150 pound adult: 340.5 mcg of aluminum
350 pound adult: 794.5 mcg of aluminum
Here are the quantities of aluminum in the vaccines that are routinely given to children are:








Hib (PedVaxHib brand only) – 225 mcg per shot
Hepatitis B – 250 mcg
DTaP – depending on the manufacturer, ranges from 170 to 625 mcg
Pneumococcus – 125 mcg
Hepatitis A – 250 mcg
HPV – 225 mcg
Pentacel (DTaP, HIB and Polio combo vaccine) – 330 mcg
Pediarix (DTaP, Hep B and Polio combo vaccine) – 850 mcg
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
20
So at birth children given the hepatitis B vaccination receive 14 times the amount of
aluminum that is FDA approved. If a baby receives 8 vaccines in one visit, and a baby
typically gets that many shots several times in his/her first year, he/she could get more than
1,000 mcg of aluminium at each visit, an amount that is not considered safe for even a 350
pound adult.
According to the FDA and the AAP (American Academy of Pediatrics), the known risks of
aluminium are:



Aluminum builds up in the bones and brain and can be toxic.
Aluminum can cause neurological harm.
Aluminum overdose can be fatal in patients with weak kidney’s or kidney disorders or
in premature babies.
Is there research that demonstrates that in a healthy child the aluminium injected in vaccines
is excreted without causing harm? Apparently not. Is there research that suggests there is
a health risk to children from the aluminium injected in vaccines? Yes. For example:


in 2013 Christopher Shaw and Lucija Tomljenovic (in ‘Aluminum in the Central
Nervous System: Toxicity in Humans and Animals, Vaccine Adjuvants, and
Autoimmunity’ Springer Science and Business Media) reported that they analysed
the Center for Disease Control vaccine recommendations from 1991-2008 and
changes in the autism rate over that period and found a ‘pronounced and statistically
highly significant correlation between the number vaccines with aluminum and the
changes in autism rates.’ ‘There are other links between aluminum exposure/toxicity
and Autism Spectrum Disorder. These include: a pilot study showed higher than
normal aluminum levels in the hair, blood and/or urine of autistic children.’ ‘and
aluminum in vaccines has been linked to serious neurological impairments, chronic
fatigue and autoimmunity’.
in 2012 Stephanie Seneff, Robert M. Davidson and Jingjing Liu, (‘Empirical Data
Confirm Autism Symptoms Related to Aluminum and Acetaminophen Exposure’)
stated ‘evidence available from the literature on the toxicity of aluminum, combined
with the evidence we present for severe adverse reactions (from the US VAERS
database) occurring much more frequently following administration of aluminumcontaining vaccines as compared to non-aluminum containing vaccines, suggests
that neuronal damage due to aluminum penetration into the nervous system may be
a significant factor in autism.’
Before leaving the subject of safety of aluminium in vaccines, please consider how the DHA
addresses this question. The DHA states: ‘The amount of aluminium in vaccines is very
small and the intake from vaccines is far less than that received from diet or medications
such as some antacids.’ Is this an appropriate response? Would the fact that someone can
safely eat many Big Macs reassure you if you were concerned about whether injecting a
small amount of Big Mac into someone is safe?
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
21
Now please consider the US regulators attitude towards placebos and whether this
demonstrates that they can be regarded as trusted regulators. A ‘placebo’ is an ‘innocuous
or inert medication’, eg a saline solution, given to a control group in experiments on the
efficacy and safety of a medicine. In the USA many trial vaccines are tested for efficacy and
safety against comparison drugs with active ingredients and the regulators both accept this
practice and allow the use of the term ‘placebo’ when describing these active ingredient
comparison drugs in later communication about the new vaccines. In these cases vaccine
providers and patients are misled when claims are made that the new vaccine was found to
be no more harmful than the placebo in clinical trials.
For example in the development of the HPV vaccine Gardasil Merck conducted several
clinical trials in which the control group participants received instead of a true placebo a drug
that contained a vaccine adjuvant (eg in one trial the adjuvant was ‘amorphous aluminium
hydroxyphosphate sulphate adjuvant’). Adjuvants are immunologically active, their purpose
is to enhance the immune system reaction to the active ingredients of the vaccine. One of
the Merck trials included a ‘non-alum placebo’ but it did contain identical components to
those in the vaccine, with the exception of ‘HPV L1 VLPs (the active HPV ingredients) and
aluminium adjuvant’. So it would have contained a combination of ingredients typically found
in vaccine ‘carrier’ solutions. In Gardasil, the carrier solution ingredients are: ‘yeast protein,
sodium chloride (table salt), L-histidine, poly sorbate 80 (an emulsifier), sodium borate
(which is a chemically reactive toxin which has been banned in some countries as a food
additive because of its toxicity). Merck did not test Gardasil against a true placebo. The
comparisons of adverse events in those receiving Gardasil and those receiving the drug with
the aluminium adjuvant showed little evidence of additional risk of injury from the ‘HPV L1
VLPs’ which simply means that both the trial vaccine and the comparison drug caused a
similar number of serious side effects.
Mark Blaxill reanalysed the safety data (see the book ‘Vaccine Epidemic’, editors Habakus
and Holland, 2012). He found that ‘serious adverse events’ occurred in 5% of the people
who received the trial vaccine, in 2% of the people who received the comparison drug that
included an aluminium adjuvant and in less than 1% of the people who received the ‘carrier’
ingredient comparison drug. He also states that when the health of the individuals who
participated in the full trial was assessed 12 months after the trials it was found that in the
groups that received the vaccine or comparison drug containing the aluminium adjuvant
there were cases of autoimmune disorders (eg arthritis, lupus, thyroiditis) but no cases of
autoimmune disorders in the ‘carrier’ group.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
22
Now please consider the way in which adverse reactions to vaccines that occur during trials
are managed. In the USA regulators allow vaccine manufacturers to deliberately exclude
from clinical trials individuals who have an immediate reaction to a vaccine. Mr Blaxill points
out that some of the Gardasil trial participants withdrew from the trial due to serious adverse
reactions (including death) within 2 weeks of receiving a dose of the trial vaccine or the
comparison drug that included the aluminium adjuvant. The health effects on the individuals
who withdrew from the trials were not included in the final calculations. As mentioned
above in H1N1 flu vaccine trials in pregnant women those who had a high temperature
within 72 hours of receiving a trial flu vaccine were excluded from the trial. Could these
women who have an immediate reaction also go on to have long-term reactions? Quite
possibly, but if you exclude them from the trial you won’t need to find out. Would a ‘trusted
regulator’ allow this?
I suggest that this Expert Panel recommend that:


the newly appointed ATAGI committee of doctors with no conflicts of interest
define a mandatory set of pre-licensing safety testing procedures for vaccines
used in Australia, this should be made available for public comment before
being adopted to ensure that no widely accepted best practice safety testing
procedures are omitted and all established best practice techniques are
included (for example in clinical trials on safety for new vaccines
manufacturers should be required to compare the trial vaccine to genuine
placebos that include only inert ingredients, for example it is common practice
for medicines to be tested in animals to assess long-term safety issues, the
HPV vaccines were never tested for safety in animals, for example trial
participants who withdraw from the trial before it is completed due to adverse
reactions should be included in the final analysis of data). If this were done the
Australian regulators would become regulators that the whole world could
trust.
all vaccines the DHA recommends be tested to these new standards and that
until this is done all vaccine providers be required to inform patients in writing
on consent forms that this vaccine has not yet been tested for safety and
efficacy to the appropriate standards.
Questions for consideration:
Should Australia introduce an accelerated approval program(s)? What are the
potential risks and benefits of such programs and how might the risks be managed
and the benefits maximised?
Until a best practice approval process is established consideration of an accelerated
approval program for vaccines is inappropriate.
I suggest that this Expert Panel recommends that:

there is no accelerated approval programme for vaccines.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
23
Questions for consideration:
Does Australia’s post-market surveillance of medicines need to be enhanced? If so,
how might this occur? What would be the features of an effective post-market
surveillance system? If not, why not? Why do you consider the current system
effective?
The Therapeutic Goods Agency (TGA) has a pharmacovigilance system which it states
enables it to respond quickly to information about adverse events associated with medicines
and medical devices used in Australia and in other countries. It gives on its website the
example of an anti-inflammatory drug that was withdrawn from use in Australia when the
TGA identified eight individual cases of serious adverse events associated with use of the
drug.
The Center for Disease Control (CDC) in America has stated that 25,000 adverse reactions
to the Gardasil vaccine have been reported (and it is known that many adverse events are
not reported so that the real number of adverse reactions is likely to be far higher). It stated
that 92% of the reported adverse events to Gardasil were not classed as serious. That
means that 2,000 young people have reported serious adverse effects. The CDC defines
‘serious’ as ‘life threatening, or results in death, a persistent or significant disability or
incapacity, congenital anomaly or birth defect, hospitalization, or prolongation of existing
hospitalization’. The Japanese government some months ago ceased recommending use of
HPV vaccines due to unacceptably high levels of serious side effects.
Does the TGA apply the same pharmacovigilance standards to vaccines, which are
medicines that are given to healthy people to protect them against diseases they may never
encounter, as to anti-inflammatory drugs? If so, why has it not withdrawn Gardasil?
I suggest that this expert panel recommends that:



the TGA issues regular, eg quarterly, reports on the status of its
pharmacovigilance knowledge on all medicines and medical devices, so that
interested individuals can see what information the TGA has received and how
the TGA has assessed and responded to this information and
the public be allowed to submit evidence of harm of medicines to other people
to the TGA so that if the TGA has not discovered significant information
through its pharmacovigilance system the public has an opportunity to bring
this information to the TGA’s attention (perhaps the TGA has not noticed or
been informed that 2,000 reports of serious adverse reactions have been made
in the USA about Gardasil?)
the TGA be required to explain to the public what the trigger levels are for
withdrawal of different categories of drugs, eg anti-inflammatories versus
vaccines.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
24
Ideas on Chapter Eight: Framework for advertising therapeutic goods
Questions for consideration:
Should Australia allow advertising of prescription medicines to the general public? If
not, why not? If yes, what risks might this create and how could these be mitigated?
Advertising of prescription medicines to the general public should not be allowed. The
Expert Panel acknowledges that advertising might carry risks which would have to be
mitigated. It is safer to avoid the risks completely by not permitting advertising than to
mitigate the risks.
Prescription medicines contain toxic ingredients which can have harmful side effects. The
purpose of advertising prescription medicines to the public is ONLY to make individuals buy
the product. Advertising can lead individuals who do not need a medicine to believe that
they need it. It can lead individuals to believe that the medicine advertised is the only or the
best solution to a medical problem when there might be other safer, better solutions.
Consider the advertising of HPV vaccines in the USA. The central theme is by taking the
vaccine a girl will become one less victim of cervical cancer. The vaccine contains toxic
ingredients which can cause serious harm and it has not yet been proven to prevent cervical
cancer. The pap smear test has already been proven to prevent cervical cancer and is
100% harmless. Girls will have to have regular pap smear tests regardless of whether they
have the vaccine. How would it be in the interests of the Australian public to create, through
advertising, demand for an unproven, toxic and potentially lethal medicine when a proven,
100% safe non-toxic alternative to that medicine is already freely available to all Australians?
Australians already have the ability to research their symptoms and find information on
prescription medicines presented by manufacturers on the internet. The sick and the
worried well can already visit their doctor and ask for confirmation of their self-diagnosis and
can discuss their need for prescription medicines they have read about. Advertising of
prescription medicines to the general public would lead to tax payer funded doctors having to
waste their time and tax payers money explaining to patients why they do not need the
advertised medicine.
Questions for consideration:
What are the risks and benefits of allowing direct-to-consumer advertising of
Schedule 3 medicines? How might any risks be managed?
The risk is that it creates false demand for medicines. This risk cannot be managed. There
are no benefits that are not already achieved through manufacturers being allowed to
explain their products on their websites and to commission research that demonstrates the
advantages of their products and through a patient’s ability to consult their doctor about their
symptoms and appropriate solutions.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
25
Questions for consideration:
Should Australia continue to require compulsory pre-vetting of medicines advertised
direct-to-consumers or should it move towards a self-regulatory, or combined
statutory and self-regulatory, model?
The method of vetting advertising to consumers is not working and should be strengthened.
In recent months a television advertisement has been shown repeatedly on the free-to-air
television channels Go! and SBS to encourage use of vaccines. It shows the pages of a
child’s pop-up picture book turning, with a song to the tune of a lullaby ‘hush little baby don’t
say a word, mummy’s going to buy you a mocking bird’. The advertisement contains a
strongly pro-vaccination message with words like ‘they help you grow up big and strong’.
How has this advertisement been allowed to go to air? Our regulations, or the method of
implementation of our regulations, are clearly not working effectively. Moving towards a selfregulatory or a combined statutory and self-regulatory model would only weaken the system.
The current system of regulation should be tightened to prevent advertising of prescription
medicines such as vaccines to the public.
I suggest this Expert Panel recommends that:

advertising of medicines direct to the public is not allowed.
Questions for consideration:
Does the current regulatory framework for advertising medicines direct-toconsumers:
 Provide adequate incentives to promote compliance with requirements? If not,
why not. What additional incentives should be included?
 Contain adequate sanctions and penalties for non-compliance? If not, what
additional sanctions and penalties should be available?
 Should the TGA have the power to take immediate action to suspend an
advertisement that it considers places at risk public health and safety?
 If yes, why and how might any risks be mitigated?
 If not, why not?
Why should Australia consider providing commercial companies with incentives to comply
with regulations? Does Australia provide incentives to people to comply with the speed limit
or to comply with the law against murder? A pharmaceutical company’s primary objective is
to make money. The only incentives they would be interested in would be financial. (I don’t
think that the incentive of a certificate of merit or brass plaque would motivate them.)
Pharmaceutical companies make profits from selling medicines in Australia under the
existing regulatory regime. In what way would it be in the public interest to give them
financial incentives, effectively to pay them to comply with regulations, when we already buy
their medicines at a price that generates a large profit?
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.
26
Clearly the current regulatory framework does not provide adequate sanctions and penalties
for non-compliance given the fact there has been a commercial encouraging use of
prescription medicines on two free-to-air television channels for months. The financial
penalties for non-compliance should be hugely increased. The TGA should be given the
power to immediately suspend advertisements that promote use of prescription medicines.
Whether or not the advertisement places at risk public health and safety is irrelevant. What
is relevant is that advertising prescription medicines to the public is not permitted and
manufacturers must comply with the regulations.
I suggest this Expert Panel recommends that:


incentives are not introduced to encourage compliance with regulations and
the current regulations, implementation methods and sanctions for breaches
all be reviewed and strengthened to prevent advertising of medicines such as
vaccines direct to the public, as has occurred this year.
Submission to the Expert Panel Review of Medicine and Medicinal Device Regulation, 2014 by a
member of the public.