HPV vaccine support group

concerned at side effects

Regret group believes vaccine causes long-term health
problems in their daughters
Fri, May 22, 2015, 01:00
Fiona Gartland

The vaccine against cervical cancer has been offered to teenage girls in
Ireland since May 2010 as part of the schools vaccination programme

A new support group, set up by parents of teenage girls

who claim a vaccine against cervical cancer has made
them ill, will be launched on the weekend of May 23rd.
The group Reaction and Effects of Gardasil Resulting in
Extreme Trauma (Regret) believes the human
pappilomavirus (HPV) vaccine, administered to
teenagers to protect against a virus that causes cervical
cancer, has caused long-term health difficulties in their
daughters.
The vaccine, offered to teenage girls in Ireland since May
2010 as part of the schools vaccination programme, is
recommended by the World Health Organisation. Its
Global Advisory Committee on Vaccine Safety has said
there is no scientific evidence the vaccines cause harm or
are related to any autoimmune syndrome.
The Health Products Regulatory Authority, which
monitors health products in Ireland, reports that it has
had 856 reports of side effects since the vaccination was
introduced. These included fainting, dizziness and
headaches at the time of vaccination, as well as malaise,
gastrointestinal symptoms and skin and injection site
reactions. These were consistent with the information
provided with the product by the manufacturer, the
authority has said.
Kiva Murphy and her daughter Kelly Power (17), from
Dublin, and Karen Smyth and her daughter Laura (17),
from Louth, told The Irish Times they believed the
vaccine caused long-term problems.
Both teenagers had said they were fit and healthy before
receiving the vaccine, but both now suffer from
symptoms including headaches, excessive fatigue,
cognitive dysfunction, gastrointestinal discomfort,
nerve-related pain, sleep disruption and light sensitivity.
Ms Smyth said she was initially told her symptoms were
attributable to the teenage years, but was eventually
diagnosed with ME, chronic fatigue syndrome, and was
told her condition would resolve itself. It did not
improve. At one point she spent 12 months in bed, she
said. She no longer attended school as she did not have
the energy.

Ms Power said she had the same symptoms, but was

initially diagnosed with depression. I knew I didnt have
depression, she said. She has also been treated for
fibromyalgia and has chronic pain.
The girls mothers, who say they are not anti-
immunisation and have given other childhood vaccines
to their children, want to raise awareness of the possible
side effects of the HPV vaccine. They would also like
support for their daughters so they can continue
education.
The group will meet in Dublin to offer support to other
families who believe they have been affected by the
vaccine.
In a statement, the HSE said the vaccine was considered
safe and well-tolerated and the side effects were usually
mild and temporary reactions.
Like most vaccines, severe allergic reactions were
extremely rare, the statement added, and there was no
evidence of long-term side effects. It also said all
vaccines used by the HSE as part of the immunisation
programme were licensed by the Health Products
Regulatory Authority and the European Medicines
Agency.
http://www.irishtimes.com/news/health/hpv-vaccine-support-group-
concerned-at-side-effects-1.2221556

GARDASILANTI
CANCERVACCINEISIT
SAFE

May7,20168
Gardasilisanantihumanpapillomavirus(HPV)vaccineintroduced
 in2010asavaccineagainstcervicalcancer.Themajorityofcervical
cancersarecausedbythechangesbroughtaboutbyHPVinfections
ofthecervix.Hence,vaccinatingagainstthisviruswouldseemto
makeperfectlygoodsensefromaPublicHealthperspective.
Butisitsafe?Thatstheburningquestion.Therearenowgrowing
concernsaboutthiswiththousandsofpreviouslyhealthyyounggirls
fromaroundtheworldreportingverygravesymptomsfollowingthe
secondorthirdshotofGardasil.Notonlyarethesymptomsgrossly
debilitatingbuttheyarepermanentandperhapsincurable.Andthat
inmyviewistoohighapricetopay.Therisk/benefitratiohere
seemstobeseriouslyskewedwhilethosewhoshouldbemost
concernedaboutthisscandalareindenial.
Thosewithvestedinterestsindeigningaconnectionbetween
GardasilvaccineandwhatIwouldliketocallPostGardasil
Syndrome(PGS)liketoshoehornthesegirlsintothediagnosisof
ChronicFatigueSyndrome(CFS)thatcoincidentallysetinafterthey
receivedGardasilvaccine.Thisargumenthoweverisseriously
flawedontwocounts.Firstofallthesymptomsofthesetwo
diseasesdifferconsiderablefromeachother.
ThesymptomsofChronicFatigueSyndromeare:
Fatigue
Lossofmemoryorconcentration
Sorethroat
Enlargedlymphnodesinyourneckorarmpits
Unexplainedmusclepain
Painthatmovesfromonejointtoanotherwithoutswellingor
redness
Headacheofanewtype,patternorseverity
Unrefreshingsleep
Extremeexhaustionlastingmorethan24hoursafterphysicalor
mentalexercise.
http://www.dailymail.co.uk/news/article2295285/Moreparents
refusingHPVvaccinationchildrenfearnonexistentsafety
concernsstudyclaims.html

ThesymptomsofPostGardasilSyndromeareverysimilarbut
theyaredifferent.Andtheyare:
Fatigue
 Lossofmemoryandconcentration
Unexplainedmuscleandjointpains
Headachesthatcanbeverysevere
Unrefreshingsleep
Extremedebilitatingexhaustion
Agreaterthanexpectedincidenceofautoimmunedisease.
Gastrointestinalsymptomslikenauseavomitinganddiarrhea.
NeurologicalsymptomsalmostlikeMStingling,numbness,
twitchingandproblemswithvisionandhearing.
ThesecondseriousflawtotheCFScoincidentallyfollowing
Gardasilinjectiontheoryistheabuseofthewordcoincidentally.
Acoincidentiswheretwothingshappenatrandomintime.
However,whenthispatternstartstorepeateditselfthousandsoftime
isloosesthestatusofcoincidentandbecomeaconsequence.
LogicallythenPostGardasilSyndromeisaconsequenceofthe
vaccineandnotacoincidentaloccurrence.
WehaveseenalltheseargumentsbeforewiththePostFinasteride
Syndromewhichmanydoctorsstilldontacceptasrealandresortto
blamingthepatient.Thisofcourseonlycompoundsthepainfor
thesufferers.
Formoreinformationonthishorriblepostvaccinediseaseplease
havealookatthishighlyinformativewebsitewww.regret.iePlease
alsothinklongandhardabouttherisk/benefitratioforyour
daughterbeingvaccinatedagainstadiseasewithamortalityrateof3
per100,000.
https://medicaladviceforyou.com/gardasil-anti-cancer-vaccine-worth-
risk/
Documenting Parental Refusal to Have Their Children Vaccinated

https://www.aap.org/en-
us/Documents/immunization_refusaltovaccinate.pdf

More parents saying no to HPV vaccine for their

daughters
While overall vaccination rates are up slightly, more parents are citing fears
about the vaccine. Doctors are encouraged to stress the immunization's efficacy
and safety.
By Posted April 1, 2013

Although human papillomavirus vaccine often is considered a pediatric issue, all

physicians should talk about the immunization with their adolescent and young
adult female patients, says the lead author of a recent study.
 The recommendation comes as a growing number of parents are choosing to
forgo the HPV vaccine due largely to doubts about its necessity and concerns
about its safety, said a study published online March 18 in Pediatrics.

I wasn't surprised that [parents have] safety concerns about the vaccine, but I'm
surprised that [the number of parents is] increasing, said lead study author Paul
M. Darden, MD, a pediatrician in Oklahoma City.

Between 2008 and 2010, there was an almost fourfold increase in the percentage
of parents who said fears about the HPV vaccine are keeping them from giving
the immunization to their daughters, the study said.

As a result, females, who are encouraged to receive three doses of the

immunization between ages 11 and 12, are entering their 20s still unvaccinated
against the virus, medical experts say.

This is very concerning to me, because there's only a small window to get this
vaccine and maintain its maximum benefits. That's before [people] become
sexually active, said Abbey B. Berenson, MD, PhD. She is director of the
Division of Pediatric and Adolescent Gynecology at the University of Texas
Medical Branch at Galveston.

Dr. Darden encourages physicians to strongly recommend the immunization to

all unvaccinated female patients between 11 and 26. He said doctors should listen
to parents' concerns, but they also should stress that they are experts in this field
and that data show the immunization is safe and effective.

For instance, an Oct. 1, 2012, study of 189,629 girls and women ages 9 to 26
found no significant adverse events associated with the immunization. The
findings were published in the December 2012 issue of JAMA Pediatrics,
formerly Archives of Pediatrics & Adolescent Medicine.

The study did show an increased risk of patients fainting at the time of injection
or developing a skin infection later. But those side effects are common with any
vaccine, particularly among adolescents, doctors say.

Much of the patient education regarding this vaccine still is probably occurring
in pediatric clinics, Dr. Berenson said. If girls aren't getting the vaccine while
they're seeing a pediatrician, providers of adults should address it.

4,000 deaths yearly due to cervical cancer

HPV is the most commonly transmitted sexual infection in the U.S. and the
leading cause of cervical cancer among women, according to the CDC. About 20
million Americans are infected with one of the more than 40 types of the virus.
About 12,000 U.S. women are diagnosed with cervical cancer each year, and
4,000 die of the disease, the CDC said.

For the Pediatrics study, researchers examined data on more than 98,000
adolescents age 13 to 17 whose parents participated in the 2008-2010 National
Immunization Survey Teen. The studied vaccines were HPV; tetanus,
diphtheria and acellular pertussis (Tdap) or tetanus and diphtheria (Td); and
quadrivalent meningococcal conjugate (MCV4).

Researchers found that adolescent vaccine rates are improving, but they still fall
below the Healthy People 2020 goals.

The percentage of females fully immunized with three doses of HPV vaccine
was substantially lower than for the other vaccines, but increased from 17.9% in
2008 to 32% in 2010. Possibly contributing to that improvement was an uptick in
physicians recommending the HPV immunization during the study period.

Despite doctors' efforts, the percentage of parents who don't intend to vaccinate
their daughters against HPV increased. In 2010, 43.9% said they did not plan to
seek HPV immunization, up from 39.8% of parents in 2008.

Largely driving that decision is a belief that the vaccine is not needed (17.4%)
and concerns about the immunization's safety or side effects (16.4%). In 2008,
only 4.5% of parents cited vaccine safety concerns as the reason they chose not to
immunize their daughters against HPV.

Dr. Berenson is not sure why HPV vaccine safety concerns are increasing.
Possibly contributing to the worries is misinformation about the immunization
that is publicized by the media or posted online, Dr. Darden said.

For instance, in September 2011, then-Republican presidential hopeful Rep.

Michele Bachmann of Minnesota told reporters that a supporter's daughter
developed mental retardation after receiving the HPV vaccine. After Bachmann's
comment, O. Marion Burton, MD, then president of the American Academy of
Pediatrics, discredited the claim.

We have good evidence that the vaccine will prevent about 70% of the cervical
cancer that we see now, Dr. Darden said. I find that convincing and
compelling.

Why parents refuse HPV vaccine

Parents give various reasons for not vaccinating their adolescent daughters
against the human papillomavirus.

Reason 2008 2009 2010

Not recommended by clinician 10.8% 8.5% 9.0%

Not needed/not necessary 14.4% 15.5% 17.4%

Lack of knowledge 15.8% 15.7% 10.2%

Not appropriate age 5.8% 4.4% 4.4%

Safety concern/side effects 4.5% 7.7% 16.4%

 Don't know 7.4% 4.8% 5.0%

Not sexually active 14.1% 12.3% 11.1%

Multiple reasons 7.2% 7.2% 9.2%

All other reasons 20.0% 24.0% 17.2%

Reasons for Not Vaccinating Adolescents: National Immunization Survey of Teens, 2008-
2010, Pediatrics, published online March 18

Safety of Quadrivalent Human Papillomavirus Vaccine Administered Routinely to

Females, JAMA Pediatrics, formerly Archives of Pediatrics & Adolescent
Medicine, December 2012 ( link)

Centers for Disease Control and Prevention on HPV and the HPV vaccine, ( link)

Reasons for Not Vaccinating Adolescents: National Immunization Survey of

Teens, 2008-2010, Pediatrics, published online March 18 ( link)

http://www.amednews.com/article/20130401/health/130409983/6/
Prescribing the facts on the HPV vaccine is
necessary
Robert OConnor outlines why some parents refuse to
allow their daughters take a vaccine to help prevent
cervical cancer and explains why they should change their
minds.
Wednesday, September 07, 2016

Families who have seen their daughters fall ill after

receiving the HPV vaccine have wrongly concluded that
the injection is to blame.

As head of research with the Irish Cancer Society, I am

used to talking with cancer researchers about the studies
we fund and the advances they make in terms of cancer
prevention, early detection, treatment, and survivorship.
But this past few weeks have been different, as Ive had
the opportunity to discuss with the general public the facts
behind one of the most significant advances in modern
cancer research: The development of a vaccine that can
substantially reduce the instances of cervical cancer
among women.
Since 2010, more than 220,000 Irish secondary school
girls have been offered the HPV vaccine for free under the
HSEs national vaccination programme. The injection
protects against the major strains of HPV (human
papillomavirus), which cause cervical cancer, and is
offered to first-year school girls each September.

That means that more than 30,000 Irish girls are now
being offered the opportunity to have their chances of
contracting cervical cancer significantly reduced.
Despite the actions of our world class cervical cancer
screening programme, roughly 280 women are diagnosed
with invasive cervical cancer each year in Ireland.
It is estimated that more than 90 Irish women will die from
cervical cancer this year, while a further 6,500 will need
hospital treatment to remove precancerous growths in
their cervix.
The vaccine protects from strains of HPV that cause more
than 70% of all cervical cancers.
If these women had received the vaccine, the vast
majority would be spared such medical treatment. Most
importantly, lives would have been saved.
Our two public talks this week, in Galway and Cork,
presented these facts and more to large audiences, many
of whom were parents anxious to learn more about the
vaccine being offered to their daughters.
Expert analysis was given by local consultant
gynaecologists and Margaret Stanley of Cambridge
University, who is a leading global expert in this field, with
her research focussing on the development of vaccines
and immunotherapies against HPV.
Also among them were powerful testimonies from young
women who have gone through a multitude of treatments
for cervical cancer.
Irish doctors use the most modern techniques for
managing this disease but treatment can be very difficult,
often involving combinations of highly invasive surgery on
the reproductive areas of the body, along with radiation
and/or chemotherapy.
Even with all the modern advances, the unfortunate truth
is that four in 10 of those women treated will succumb to
their cancer within five years.
Many of those women will be young. Some will be young
mothers, while others will perhaps not have children but
treatment will often rob them of that option in their life.
Again, the HPV vaccine would have relieved many of these
women the emotional and physical pain this disease has
caused.
However. despite this, more and more parents are opting
not to give their daughter the vaccine.
Provisional figures from the HSE show that 5,000 fewer
first-year girls received the vaccine in the last academic
year compared to the 2014/2015 cycle.
That means that 9,000 girls were offered the injection last
year but either they or their parents chose not to receive
it.
Which begs the question: Why? Recently through the
media and from listening to personal stories, the Irish
Cancer Society has heard from families who have seen
their young girls battle severe ailments that, in many
cases, have left them bedridden.
The true stories they tell are harrowing, and as they
search for reasons why their daughters have fallen ill, they
conclude that the HPV vaccine was the cause.
This conclusion understandably creates a fear around the
injection.
While I sympathise with the real ailments these girls
endure, as a representative of the Irish Cancer Society I
have an obligation to present the facts, which show that
the vaccine is safe.
Worldwide, more than 200m doses of the vaccine have
been given to around 80m people. Recent studies from
leading international medical agencies, including the
World Health Organisation and the European Medicines
Agency, have concluded that Gardasil, the vaccine offered
to Irish girls, is safe and has no link to serious illnesses.
All medicines can cause effects in some people. The HPV
vaccine is a needle so, like MMR and every other
common vaccine we get, many will feel pain from the
injection.
An ache in the muscle or an unwell feeling for a few
minutes to a few hours is not uncommon.
There are rare side effects but the number and rate of
these is incredibly low and the risks of even the more
common of these effects is much less than many things
we do in our daily life like being in a car or playing a sport.
In reality, the possible outcomes women face from a
cervical cancer diagnosis far outweigh the risks perceived
from the HPV vaccine.
As cervical cancer survivors spoke at our talks in August,
they all had a common message to tell: If the HPV vaccine
was available to them when they were in school, they
wouldnt have hesitated in taking it.
Dr Robert OConnor is head of research with the
Irish Cancer Society

Irelands HPV Vaccine Injured Fight for Human Rights in

Dublins High Court

Fiona Kirby with supporters outside of High Court

byJeffereyJaxen
HealthImpactNews

Fightingfortherecognitionoftheirvaccineinjureddaughtersintheeyesof
healthcareandpoliticalpolicy,growingnumbersofIrishmothersandfathers
throughoutthecountryaregarneringtheworldsattention.Atthesametime
throughoutIreland,manyareaskingfortheHumanPapillomaVirus(HPV)
vaccinetobewithdrawninthecountry.

CountriesgloballyareexperiencingtheirnewlyunveiledmandatoryHPVvaccine
programsinvariousstagesofdeteriorationandfailure.Amidstthischaos,aperfect
stormofwelldeservedbadpress,mountingHPVvaccineinjuryandpolitical
apathyhasdescendeduponIreland.

MainstreamspecialreportsandnewsstoriescomingfromtheEmeraldIslecontinue
tocastalightonthenegligentsilenceofIrelandspoliticalclass.TheIrishhealthcare
systemisrapidlylosingtherespectofitspeoplethroughyearsofmisdiagnosing
Gardasilvaccineinjuryandmedicalincompetenceinitstreatment.Themishandling
andinactionregardingIrelandsvaccineinjureddaughtersisnowfrontandcenterfor
theworldtoseeinDublinsHighCourt.

Kirbys Fight for Gardasil Injured Girls and

Their Parents
OnMarch3,FionaKirby,anursefromKilbeggan,CoWestmeathappearedin
DublinsHighCourtwithanunwaveringdemand.Kirbyistakingherfighttothe
HighCourtseekingtheHealthProductsRegulatoryAuthoritytowithdrawtheHPV
vaccineinIreland.ThemotherofanHPVvaccineinjureddaughter,Kirbyhasvowed
nottoquitinherefforts.IrelandisoneofthefewcountriesinTheEuropeanUnion
thatdoesnothaveacompensationprogramforvaccineinjury.

Kirbys11yearolddaughter,within24hoursofreceivingtheGardasilvaccinein
October2011,developedsevereflulikesymptomswhichreappearedafterthechild
gothersecondHPVshot.Kirbydidnotallowherdaughtergetathirdshot.Her
daughterbecameextremelyfatigued,sufferedseverenauseacausingweightlossand
musclewastage.

Likesomanyparentsaroundtheworld,Kirbythoughtherdaughtersproblemswere
anisolatedcase.Yet,shecametounderstandthatglobally,aswellasthroughout
Ireland,thereareothergirlssufferingsimilarcontinuouslifechanginghealth
problemsafterreceivingtheHPVvaccine.

Meanwhile,in2013,JapansregulatorsaccomplishedthetaskKirbyisnowseeking
aftermountinginjuriesfromtheHPVshotforcedJapaneseofficialstoconvenean
emergencypublicdebate.Despiteargumentsbymedicalbodiesclaimingvaccine
injurieswerepsychosomatic,JapanofficiallywithdrewitsHPVshot
recommendation.Colombiaisnowinthemiddleofasimilarbattleasthecountrys
ConstitutionalCourthasorderedmultiplehealthagenciestoinvestigatetheirgrowing
HPVvaccineinjuries.

BrazilhasgoneastepfurtherinseeingtheFederalPublicMinistry(MPF)fileaCivil
ActionaskinghealthofficialstosuspendtheapplicationoftheHPVvaccine
throughoutthecountryaswellasitsauthorization,importation,production,
distributionandmarketingoftheshot.

OutsidetheDublincourt,familiesprotestedandralliedinmasssupportrevealinga
scenethatisbecominganalltoocommonglobaloccurrence.TheHealthProducts
RegulatoryAuthority(HPRA)isaskingtheHighCourttodismissthecase.
MainstreamnewsoutofIrelandisreportingtheHPRAisattemptingtopassthebuck
inanappealtoauthoritybyclaimingtheyarenottheappropriatedefendantinthis
case.TheHPRAhaspleadedthatonlytheEuropeanCommissionholdsthepowerto
revokeGardasilsEUmarketingauthorization.YetprominentlydisplayonHPRAs
websiteundertheheadingWhatwedo,theauthorityboasts:
We grant licensees to companies to make, distribute and market medicines after a
review of their safety, quality and effectiveness.

We continuously monitor medicines, medical devices and other health products,

responding quickly to any safety or quality concerns.

DenmarkintroducedtheHPVvaccinein2009andsawasimilarupwardtrajectoryof
compoundingsevereadversereactionsasinIreland.Recently,DanishHealthand
MedicinesAuthoritydemandedtheEuropeanMedicinesAgency(EMA)
PharmacovigilanceRiskAssessmentCommittees(PRAC)reassessthesafetyofthe
HPVshot.

However,thecommitteesreviewin2015didnotchangetheagencyspositionthat
thebenefitsoutweightherisks.Since2014theEMAhasbeenberatedwithpublic
pressuretoendconflictsofinterestwithintheagencyanditsleadership.AEuropean
CourtofJusticerulingoustedGuidoRasisappointmentasheadoftheEMAin2014
promptingEuropetocallintoquestiontheentireagenciesreputation,integrityand
trueindependence.

Scandalous: Informed Consent and Injury

Risks Regarding HPV Vaccine Absent
AmajorpointofcontentionbyIrishparentsisthefactthatproperinformedconsent
wasnotgiveninthe6yearssincetheHPVshothasbeenimplementedinthecountry.
Infact,IrelandsHealthauthority(HSE)specificallyinstructedlocalhealthcare
providersnottogivethePatientInformationLeaflettoparents.

Instead,awatereddownversionofcherrypickedinforegardingGardasilwasgiven
toparentsexaggeratingtheshotsclaimsanddownplayingadversereactions.The
continuedimproperinformedconsentaccompanyingthesevaccinesinIreland
wastrumpetedbyIrishSenatorPaschalMooney.

In October of 2015, Mooney delivered a heated speech in

the House of the Oireachtas directed at the Irish medical
system for their lack of medical ethics, willful fraud, and
negligent handling of HPV damaged girls. Mooney also
put on notice a request for Irish Health Minister Leo
Varadkar to come before the house and explain his flawed
national policy in regard to Irelands HPV vaccination.
To this day, Irelands entire mainstream medical system is
playing catch-up to learn what severe HPV adverse
vaccine reactions look like. Since 2010, Irelands
healthcare system has handled adverse reactions from
Gardasil by throwing psychiatric drugs at complaints
and/or ordering countless test to decipher, on the fly, what
they should have been taught to look for and treat in 2010.
Since there remains a void in Ireland where vaccine injury
compensation and support should be, the resultant
medical bumbling has bankrupted families paying out-of-
pocket in an endless tragic healthcare merry-go-round.
In every country where the HPV vaccine is pushed,
growing numbers of injured daughters and concerned
parents begin to sound the alarm. Looking at recent
history, as the numbers of injured mount and the voices
get louder, it is only then that individual health
bodies/authorities make a public statement assuring their
populations that the shot is safe and effective a simple
lie disproven through continuous documented research.
For those reading about the struggles of Irish parents and
their daughters, these circumstances are not isolated
incidences. Colombia, Brazil, Japan, New Zealand, Spain,
Italy, France, the U.S., India and numerous other countries
are seeing massive resistance and pushback from their
populations as severe adverse vaccine reactions continue
to leave a wake of injury and regret.
Coming around full circle back to Dublins High Court,
lawyers for Irelands Health Products Regulatory Authority
have asked Mr. Justice Tony OConnor to fix a date to hear
its application to have the case dismissed. The judge
adjourned the matter to March 15 for the hearing of the
application to dismiss. Regardless of the High Courts
eventual decision, the genie is out of the bottle in Ireland
as parents are backing away from the shot and
mainstream news is spotlighting its dangers.
The global medical community is also experiencing a
major divide about the safety and effectiveness of the HPV
shot. While peer-reviewed research is mounting to reveal
the shots dangers, medical journals continue to blacklist
unfavorable studies from ever seeing the light of day. To
compound the tensions, vaccine whistle blowers alerting
the public are ignored while research fraud to hide vaccine
dangers comes and goes without justice.

Young women whose lives were destroyed by Gardasil.

Paschal Mooney - HPV vaccine - October 8 2015
https://www.youtube.com/watch?v=OSpu0XLV9sI

Jonathan Irwin
fears for daughter
Molly after HPV
vaccine side-
effects claim
CALL FOR GOVERNMENT ACTION

Paula Campbell
19 May 2017
Email: paula@leinsterleader.ie

Jack and Jills Jonathan Irwin has a strong message for the
government this week to stop vilifying worried parents and to list
the manufacturers side effects with the HPV vaccine for young
girls.
As a worried parent himself Jonathan spoke to the Leinster Leader
about the issue, after his daughter Molly has been dogged with ill
health since she got the vaccine aged 13.
My now 17-year-old daughter, who was so athletic before she had
this vaccine, has been left bed-ridden, experiencing debilitating,
chronic health issues as a result of this vaccine. Thats a fact, he
said.
The vacine is supposed to be a safeguard against cervical cancer.
He insists that he is not anti-vacine but he claims parents were not
given a full list of the possible side effects from the HSE.
I want to send a message to the Minister for Health, as my
daughter is one of those chronically ill as a result of Gardasil HPV
vaccine, he said.
Please stop vilifying parents, like me, when we are simply telling
the truth and start sharing the full list of side effects of this vaccine,
rather than an edited version. I am compelled to speak up about
my daughter's chronic illness in the aftermath of the HPV vaccine
Gardasil and to send a message to Minister Harris to please stop
vilifying parents, like me, when we are simply telling the truth about
our family experience.
Concerned parent
The Jack and Jill founder added that he is not a member of or
spokesperson for Regret but simply a concerned parent who
expects better.
I am doing this as a very concerned father who cant sit back
when our Minister for Health and our health service refuse to
accept that there is a problem with Gardasil and try to shut down
the voice of parents by labelling them alarmists.
As we connected our daughters health demise to the time of
vaccination, it was deeply shocking to discover her symptoms were
listed, in black and white, in the side effects section of the
manufacturer patient information leaflet (PIL) which we never
received.
His fears are that his daughter, who is currently receiving treatment
abroad, may never fully recover or go on to have children one day.
"We've got a daughter who may never recover," he said. "I want a
review, I want all the girls affected to be given treatment. Why
should we have to go abroad? It's outrageous. My child has lost
her teenage years and she may never be able to have a baby. I am
asking people to please read the pamphlet carefully. I am not anti-
vaccines I think with proper testing and proper information but this
is a very young vaccine and we don't know if it works yet."
He has asked the Minister for Health to explain why families are
being denied informed consent in the withholding of the
manufacturer PIL which lists adverse effects not listed on the HSE
leaflet. And to put in place a proper investigation of those who have
had an adverse reaction, an appropriate treatment and redress
plan.
He is still waiting a response.

The side effects as listed by the HSE

According to the HSE, the human papillomavirus (HPV) vaccine

protects girls from developing cervical cancer when they are
adults. Like most vaccines, severe allergic reactions are extremely
rare, according to the HSE.
The HSE has offered the HPV vaccine to all girls in first year in
second level schools since 2010 to protect them from cervical
cancer in adulthood. HPV vaccine is offered to this age group
because the response to the vaccine is best at this age.
The vaccine is recommended by the World Health Organisation,
the International Federation of Obstetricians and Gynaecologists;
the National Immunisation Advisory Committee says that HPV
vaccines have been shown to be very safe.
The HSE says that for more than 10 years the safety of the HPV
vaccine has been strictly monitored and frequently reviewed by
many international bodies including: the European Medicines
Agency (EMA); the Global Advisory Committee on Vaccine Safety
of the World Health Organization; and the Centers for Disease
Control and Prevention in the US.
These international bodies have continually reported that the
vaccine is safe with no known long-term side effects.
The vaccine can cause some short term side effects they say.
These may include: pain, redness or swelling in the arm where the
vaccine was given; headache; dizziness; nausea; and/or a mild
fever.These can be treated with paracetamol or
ibuprofen.Occasionally girls faint after getting an injection. The girls
will be advised to sit down for 15 minutes after the vaccination.
This helps prevent fainting. Rarer side effects include: wheezing
(bronchospasm); or an itchy rash or hives.
In Ireland 660,000 doses of Gardasil have been administered
and more than 200,000 girls have been fully vaccinated against
HPV.
The Department's response
Meanwhile the Department in response to a Leinster Leader query
said that while no medicine (including vaccines) is entirely without
risk, the safety profile of Gardasil has been continuously monitored
since it was first authorised both nationally and at EU level.
"The Department is aware of claims of an association between
HPV vaccination and a number of conditions experienced by a
group of young women. An illness that occurs around the time a
vaccine is given and is already known to be common in
adolescence does not imply the vaccine caused the problem. It
appears that some girls first suffered symptoms around the time
they received the HPV vaccine, and understandably some parents
have connected the vaccine to their daughters condition. It is
important to reassure people that anyone who is suffering ill health
is eligible to seek medical attention, and to access appropriate
health and social care services, irrespective of the cause of their
symptoms. The diverse nature of these symptoms, which can have
both physical and psychological causes, are shared by many
conditions which has implications for both diagnostic and treatment
services. The individual nature of the needs of some children may
require access to specialist services and the HSE are currently
working to put in place clinical care pathways appropriate to the
differing medical needs of this group. As there is no scientific
evidence that the vaccine causes long term illnesses, the HPV
vaccine cannot be held responsible for these illnesses. It is
important to counter misinformation in relation to the safety of
vaccines, and to increase the uptake rates of all vaccines in the
States immunisation programmes. The scientific evidence is clear
and misinformation is causing real harm to those unvaccinated
children and adults who develop vaccine preventable diseases,
and to people who seek inappropriate treatments for real
conditions that are not caused by vaccines. The benefits of HPV
vaccines outweigh the known side effects. The safety of these
vaccines, as with all medicines, will continue to be carefully
monitored and will take into account any future new evidence of
side effects that becomes available."
http://www.leinsterleader.ie/news/community-
news/250799/jonathan-irwin-fears-for-daughter-molly-after-hpv-
vacine.html
The aluminium adjuvant used in the Gardasil HPV vaccine
is a sulphated version of aluminium hydroxyphosphate
and is likely, based upon what we know about aluminium
chemistry, to be even more toxic." Read more here -
written by the world's leading expert on aluminum, Prof.
Chris Exley.
Aluminium adjuvants in vaccines - The Hippocratic
Post
How do you express a legitimate concern about aluminium
adjuvants in vaccines without being labelled as anti-vaccine? We
are studying the role and efficacy of aluminium adjuvants used in
vaccines. We have been researching the impact of
HIPPOCRATICPOST.COM

IRISH PARENTS NOW DOING THE

JOB OF THEIR FAILED HSE HEALTH
SYSTEM
5/6/2017

If you want something done you have to do it yourself. Ireland's do nothing HSE
healthcare system has specifically directed schools and medical workers NOT give
parents the HPV vaccines Patient Information Leaflet (PIL) which list the
adverse reactions of the shot. As HPV vaccine injury mounts in the country the
government has not only ignored parent's demands for such informed consent, 'officials'
have also denied any link between the HPV shot and the growing number of severe
adverse reactions experienced by the teenage girls. The Irish government's official stance
on the documented severe adverse reactions is to blame the girls calling their symptoms
"psychosomatic" or all in their head. In addition, the mainstream media in Ireland has
taken up the abuse echoing the government's talking points by mounting a coordinated
campaign attempting to discredit the girls and attack their parents for the countries failing
HPV vaccine uptake. In this wake of this Irish, institutionally-backed persecution, mothers
have taken it upon themselves to make their own PIL to give perspective HPV vaccine
recipients the informed consent that was purposely denied to them and their daughters.
https://informparents.files.wordpress.com/2017/05/gardasil-
brochure-2017.pdf

AUTHORITARIAN IRISH HEALTH

MINISTER HARRIS SLAMS
PARENTS ASKING FOR INFORMED
CONSENT
Gardasil will become the greatest medical scandal of all time. Dr.
Bernard Dalbergue

Anna Cannon from REGRET speaks to Irish Parliament

Committee 03/12/2015
Dec 4, 2015
Anna Cannon from REGRET (support group) speaks before Irish Parliament Committee on
the subject of post-HPV vaccine serious illlness among Irish teenage girls.
R.E.G.R.E.T. stands for "Reactions and Effects of Gardasil Resulting in Extreme Trauma".

https://www.youtube.com/watch?v=KlhsU0w1TZU

Gardasil will become the greatest medical

scandal of all time. Dr. Bernard Dalbergue

IntheUnitedStates,theideaofmandatoryvaccination,vaccine
damage,andinformedconsentisreachingaboilingpointamongstthe
countryspopulation.Yetthemainstreammediacoverageregarding
vaccinesiseitheronesidedinfavortheshotsorcompletelysilent.The
combinationofanongoingmainstreammediaastroturf
campaigncoupledwith70 percentofmainstreammedia
advertisingrevenuescomingfrompharmaceuticalcompanieshas
renderedU.S.mainstreammediaincompetentintheirreportingabout
thedangersofvaccines.

Fighting Irish Parents

Meanwhile, in Ireland, the support and activist group

Reactions and Effects of Gardasil Resulting in Extreme
Trauma, or R.E.G.R.E.T. has brought worldwide attention
to the countrys mounting HPV vaccine injury, political
apathy and mainstream medical incompetence
surrounding the issue.

Set up by dedicated parents of teenage girls who

developed serious adverse reactions after taking the
HPV vaccine Gardasil, R.E.G.R.E.T. is making the Irish
media do their job and the medical community take
notice. The increasing media attention is serving to give
a black eye to the Irish medical communitys lack of
proper informed consent an unfortunate trend being
seen both in the Europe Union and the United States
that is damaging the integrity and trust of their
respective medical systems.
The Irish HPV vaccination campaign started in 2010 as
teenage girls began receiving Mercks Gardasil through
a collaboration with the school systems. In Ireland, the
teenage girls (and perhaps soon boys) are given the
shot on school grounds.

The Irish Health Service Executive (HSE) in collaboration

with the National Immunisation Steering Group
specifically instructs educational facilitates and school
staff administering the HPV vaccines to not include a
patient information leaflet. Instead, parents considering
signing the HPV consent forms for their daughters are
allegedly given a marketing leaflet that says nothing
about the serious, long-term side effects.

This fact alone would violate informed consent laws and

regulations of virtually every medical governing body
and medical association worldwide. In addition, Irish
schools have allegedly made little to no exceptions for
special needs children giving them the HPV vaccine as
well.

Anna Cannon is a member of R.E.G.R.E.T. whose

daughter began experiencing severe adverse reactions
after the HPV vaccination. Cannon recently testified for
the Irish Parliament in a hearing to suspend the HPV
vaccine program. Her testimony recounted her
experience with the Irish medical system as well as her
daughters debilitating health deterioration by saying on
record:

We were not given this information when

signing the consent forms for our daughters to
get vaccinated with the Gardasil HPV vaccine in
the first-year of secondary school. Instead, we
are given a marketing leaflet outlining 59 side-
effects. Nowhere did it tell us [the parents] of the
risk of long-term chronic life-changing side
effects. It didnt tell us about the daily severe
headaches our girls struggle with for years. The
nausea and stomach pains, the debilitating
fatigue, the fainting and seizures, and the onset
of autoimmune disorders. It doesnt tell us that
we might regularly end up in the A&E [accident
and emergency] department watching our
teenagers scream in pain while doctors rule out
one condition after another.
Adverse Reactions Ignored

UnliketheUnitedStates,Irelandhasnovaccineinjurycompensation
program.A reportcreatedfortheMinisterofHealthandChildren
callingfortheformationofacompensationprogramin2009was
ignored,essentiallyleavingIrishcitizenshelplessagainstvaccine
damage.

IrelandsHealthProductsRegulatoryAuthority(HPRA)hadtheability
totracktheHPVsideeffects,yetparentswereapparentlynotmade
awareofitsexistence.Tocomplicatematters,theHPRA,likethe
VAERSsystemintheU.S.,isgrosslyunderutilizedbymedical
professionalstoreportvaccineadversereactions.

TheendresulttodateinIrelandhasbeenamedicalcommunitycaught
unawareofwhatHPVvaccinereactionslooklikeandhowtotreat
them.Inthefaceofmedicalignoranceandabrokenreportingsystem,
apotentialHPVvaccineadversereactionepidemichasgone
unnoticed.

TheIrishHighCourtignoredcallsbyitspeopletohalttheHPV
programandruledinsteadtoupholdtherecentrecommendationsofthe
TheEuropeanMedicinesAgencys(EMA)PharmacovigilanceRisk
AssessmentCommitteewhoconcludedthatthereisnoreasonto
changethewaythevaccinesareusedoramendthecurrentproduct
information.ThisEMAinvestigationwasinitiallypromptedbythe
demandsofDanishhealthauthoritiesasthecountrywasexperiencing
itsownincreaseinHPVrelatedseriousadversereactions.

The combination of alleged blatant violations of

informed consent, lack of medical ethics, and ignoring
families coming forward with vaccine injured teenagers
prompted Irish senator Paschal Mooney to call his
countrys HPV program a national disgrace in October
2015. Irish Minister for Health Leo Varadkar has
repeatedly refused to meet with the parents of 140
previously healthy Irish girls who are suffering ongoing,
chronic, and long term debilitating health issues.

Since Senator Mooneys speech, the Irish mainstream

print and television media has kicked into high gear
reporting almost daily about the HPV vaccine adverse
reactions. Varadkar attempted and failed to calm Irish
parents by stating in July of 2015 that the HPV vaccine
has been monitored for safety in Ireland and is effective.

Meanwhile, behind the scenes, he was busy drafting

a major package of patient safety reforms overhauling
adverse events reporting, detecting worrying patient
safety trends, and increasing public confidence in Irish
health services that was later rolled out in November of
2015.

Kiva Murphy helped set up the support group

R.E.G.R.E.T. after her daughter Kelly was hit hard with
serious adverse reactions directly after her Gardasil HPV
vaccination. Kiva and Kelly have been strong public
voices in Ireland bringing awareness to the safety
concerns of the vaccine, the political apathy to change
the current status quo, and the Irish medical
communitys inability to recognize and treat these
severe adverse reactions. Kiva and Kelly recently
appeared on Irelands TV3 morning show
titled Sunday :am recounting their story:

Kelly: After the last shot [three total] is when I

started noticing my symptoms. Chronic
headaches, chronic fatigue I never understood
why I was so tired all the time. Chronic pain, I
couldnt stay in school.

Kiva: I noticed quite soon after the third

vaccination, Kelly would come home from school
and she would be completely washed out looking.
Shed complain about going to bed at night and
not being able to sleep properly. Or that she
would actually sleep for so long but she didnt
feel anyway refreshed.
http://vaccinecommonsense.com/2015/12/15/gardasil-will-become-
the-greatest-medical-scandal-of-all-time-dr-bernard-dalbergue/
Irish Government Calls for Investigations
on Gar

Senator Paschal Mooney

by SaneVax.org
Senator Paschal Mooney calls the Irish HPV vaccination
program a national disgrace condemning the national
health authorities for ignoring the basic right to informed
consent and ignoring pleas for answers from families
affected by adverse health after Gardasil injections. He is
putting forth a resolution aimed at forcing the HSE
(national health agency) to meet with affected families and
answer their questions.
He also mentions how the packet insert for the Gardasil
vaccine lists 21 side effects, and that this information is
not being passed on to the parents and girls between 12
and 17 years of age before deciding whether or not to
receive the vaccine.

Kudos to the Irish R.E.G.R.E.T (Reactions and Effects of

Gardasil Resulting in Extreme Trauma) group for
successfully raising awareness of the evil side of
Gardasil.dasil Vaccine Injuries

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Big Pharma and government health authorities are trying
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the cause of Vaccine Impact, part of the Health Impact
News network.

Varadkar insists cervical

cancer vaccine is monitored
for safety
Fianna Fil express concern about jab offered to girls
aged 12
Wed, Jul 15, 2015, 16:29 Updated: Wed, Jul 15, 2015, 16:53
Mary Minihan

Minister for Health Leo Varadkar has insisted the

cervical cancer vaccine is continually monitored for
safety after Fianna Fil expressed concern about the jab
offered to girls aged 12.
Fianna Fil Senator Darragh OBrien said he was calling
for a review of suspected cases of serious side effects
associated with the human papillomavirus (HPV)
vaccine, Gardasil.
Mr OBrien said a programme to tackle cervical cancer
was vital and it was crucial that the intervention was not
stalled or interrupted in anyway.
However, we do need to get to the bottom of reported
cases of very serious side-effects from the vaccine, he
said. I have spoken to a number of parents whose
daughters became seriously ill after receiving the
vaccine. These were happy, active girls who now struggle
to get out of bed due to severe dizziness, seizures,
lethargy, headaches and joint pain.
Mr OBrien said the European Medicines Board had now
instigated a review of the vaccine. Mr OBrien wrote to
Mr Varadkar outlining his concerns last month and the
Minister replied saying immunisation was regarded as
one of the safest and most cost-effective of health care
interventions.
He said the vaccine had been authorised for use across
the European Union since September 2006 and was first
introduced into the Irish national immunisation
programme in 2010.
Mr Varadkar said the vaccine was available free of
charge from the HSE for all girls in first year of
secondary school. It prevented them from developing
cervical cancer when they were adults, he said.
While no medicine (including vaccines) is entirely
without risk, the safety profile of Gardasil has been
continuously monitored since it was first authorised
both nationally and at EU level, he said.
Mr Varadkar told Mr OBrien that up to May 31st of this
year the Health Products Regulatory Authority (HPRA)
had received 861 reports of suspected adverse drug
reactions in association with the vaccine.

He said this was consistent with what was outlined in the

product information. The majority of reports received to
date involved malaise, headache, myalgia, fatigue,
gastrointestinal symptoms and skin reactions.
Vaccination-related events such as fainting and dizziness
were also reported, but those would not be unexpected
in this patient population, he said.
The HPRA continues to ensure that the quality, safety
and efficiency of all vaccinations licensed in Ireland
including HPV meet the required standards.
http://www.irishtimes.com/news/health/varadkar-insists-cervical-
cancer-vaccine-is-monitored-for-safety-1.2286045
Varadkar announces major package of patient safety
reforms
12.11.2015

Minister for Health Leo Varadkar has announced a major package

of patient safety reforms including plans to simplify the complaints
procedure, enhance the powers of the Ombudsman and HIQA,
and a tranche of patient safety legislation. In addition, he is
collaborating with Frances Fitzgerald, Minister for Justice and
Equality on measures to reduce the time taken for a legal action to
be resolved and to reform methods of compensation payments.
The measures also include plans for an annual national patient
experience survey, the creation of a National Patient Safety Office
and a patient advocacy service to provide advice and detect
 worrying patient safety trends in healthcare. They were agreed at
Cabinet this week and formally announced by the Minister at the
Fifth National Patient Safety Conference in the Aviva Stadium
today.
Minister Varadkar said: Patient safety should be at the heart of
everything we do as a health service. Although progress has been
made in some areas, there have been some very high-profile and
tragic exceptions which have damaged public confidence in the
health service. Thats why we have prepared the most wide-
ranging package of patient safety measures in Irish history.
For patients and their relatives, the experience of making a
complaint can be bewildering. We will simplify the complaints
process and look to extend the powers of the Ombudsman to cover
clinical issues. The annual patient experience survey will also give
us first-hand feedback. We can learn a lot by listening to patients
and knowing more about how they rate individual hospitals or
services. A package of legal reforms will reduce the length of court
cases, while plaintiffs will be entitled to regular index-linked
compensation payments instead of a lump sum. Open Disclosure,
where healthcare professionals are open and transparent with a
patient following an adverse incident, will be supported through
legislation. The National Patient Safety Office will help to drive the
overall patient safety agenda. All these initiatives should put the
patient first, improve their experience of the health service, reduce
harm and reduce costs, and ultimately save lives.
Details
The general patient safety measures comprise:
Simplify the complaints process and look to extending the remit of
the Ombudsman across the health service in consultation with the
Department of Public Expenditure and Reform and other interested
parties;
Conduct a National Patient Experience Survey across all hospitals.
This survey will be conducted annually using recognised guidelines
to allow international comparisons;
 The National Healthcare Quality Reporting System, first published
in 2015, will continue to be published annually;
Run ongoing Patient Safety Campaigns with defined safety targets
such as reducing medication errors;
Set up a National Patient Safety Office in the Department of Health
to report directly to the Minister, oversee the programme of patient
safety measures and advise the HSE, HIQA and health
professional regulatory bodies on patient safety issues;
The Patient Safety Office will be guided by an independent
Advisory Council, established through public invitation from the
Public Appointments Service. This will advise the Office, publish
independent patient safety reports prompted by safety information,
and act as an early-warning mechanism;
Set up an independent National Patient Advocacy Service as
recommended in the HIQA Portlaoise Report to provide advice and
information directly to patients;
Implement the Code of Conduct for Health & Social Care
Providers;
A National Patient Safety Surveillance System will collate data
from across the health service to help the HSE to monitor patient
safety, and to guide Government health policy.
There is also a package of patient safety legislation aimed at
patients including:
The Health Information & Patient Safety Bill, the general scheme of
which was published today, will make it mandatory to report events
which result in death or serious harm;
Under this Bill HIQAs remit on setting standards, monitoring
compliance with standards and carrying out investigations will be
extended to private operators, including private hospitals, and high
risk activities in cosmetic surgery clinics;
Periodic Payment Orders will allow people who experience serious
injury during healthcare to receive the cost of future care in the
form of index-linked payments every few years, instead of the
current system of lump-sum awards (through Department of
 Justice and Equality legislation);
Open Disclosure will be supported through legislation to support
the system currently in operation in the health service (again
through the Periodic Payment Orders legislation);
Pre-Action Protocols will reduce the length of time required to
complete legal proceedings and the cost involved, and reduce the
stress for plaintiffs and their families (through a Bill from the
Department of Justice & Equality);
The enactment of the Medical Practitioners Bill in the coming
months to require that all doctors who practise medicine must
provide evidence that they have adequate indemnity cover when
they register with the Medical Council or on annual retention of
registration;
Patients will have a right to transfer their medical records when
they change GP or health professional;
It will be a criminal offence for those involved in healthcare to buy
or sell personal health information;
A Patient Safety Licensing Bill is being developed to introduce a
formal licensing regime for public and private healthcare providers.
Read the Ministers presentation here.
Ends
Further information
Note for Editors
Cross Departmental Approach to Tort Reform and Legislation
The Government has given its approval to the drafting of provisions
to support Open Disclosure of patient safety incidents. This will be
included in the Department of Justice and Equalitys draft Bill on
Periodic Payment Orders which is well advanced. The legislation is
part of a broader package of reforms aimed at improving the
experience of those who are affected by adverse events. With the
enactment of Periodic Payment Order legislation catastrophically
injured people will receive the cost of future care in the form of
index-linked payments every few years, instead of a lump sum
award, which is what they must rely on under the present system.
This legislation builds on the joint development by the HSE and
State Claims Agency of the National Policy on Open Disclosure. It
is now two years since this policy was launched by the HSE, but
perhaps its full impact will not be felt until this legislation is put in
place.
The Department of Justice and Equality is also preparing
legislation, as part of a Legal Services Bill, to introduce Pre-Action
Protocols which will facilitate more efficient processing and
conclusion of court cases. This is in everyones interest as it will
considerably reduce the length of time that it takes to complete
legal proceedings and the cost of those proceedings. This, in turn,
should also reduce the stress involved for plaintiffs and their
families.
In addition Government agreed last month that there will be a
review of the State Claims Agency and how clinical negligence
claims are handled.
Medical Practitioners Amendment Bill
Legislation which was passed in the Seanad last week will be
enacted in the coming months, which will require that all doctors
who practise medicine must provide evidence that they have
adequate indemnity cover when they register with the Medical
Council or on annual retention of registration. The minimum levels
of indemnity for all types of medical practitioner will be set by the
State Claims Agency. Currently some doctors consider that they
have adequate cover, but this may not be the case.
Health Information and Patient Safety Bill
The Government approved on Tuesday 10th November, 2015 the
drafting of the Health Information and Patient Safety Bill. The Bill
will cover a range of issues including measures to support clinical
audit and patient safety incident notifications. The adverse incident
reporting and clinical audit measures in the Bill will help promote a
culture of patient safety and build a health service which can
identify, respond to and learn from error and monitor and commit to
on-going quality improvement through identifying opportunities for
improvement.
The Bill also facilitates the appropriate sharing of information
between regulatory bodies where the disclosing body has a
reasonable belief that the information is relevant to other
regulators.
The Minister is adopting a phased approach to the regulation of
healthcare services. The Government has given approval to allow
the Department to draft amendments to the Health Act 2007 which
will allow HIQA to set and monitor standards in private hospitals
and for certain cosmetic surgery procedures. These measures
have been included in the Health Information and Patient Safety
Bill which will be drafted in 2016. In addition a Patient Safety
Licensing Bill is being developed which will introduce a formal
licensing regime for public and private healthcare providers.
Patient Complaints and Advocacy
The management of clinical and non-clinical complaints is being
examined. Currently there is a distinction between the
management of clinical and non-clinical complaints. It is the
Ministers intention to ensure that patient complaints relating to
clinical issues can be dealt with in the first instance by health
service providers and, therefore, by extension by the Ombudsman.
In addition work on a new independent national model for patient
advocacy as recommended by the HIQA Portlaoise Report has
commenced. This advocacy service will be external to the
Department and the HSE and will be in line with international best
practice.
Health Intelligence and Patient Experience
In March this year the first annual report of the National Healthcare
Quality Reporting System was published. This system will publicly
report on an annual basis on performance indicators that reflect on
the quality of the healthcare provided at national, regional and
hospital level. This will allow comparison on the quality of
healthcare across our country and at international level.
One of the recommendations of the CMOs Report into Portlaoise
was the development of a National Patient Safety Surveillance
System.
A National Patient Safety Surveillance System will be established
in 2016. This will produce patient safety profiles by bringing
together data from various health information resources and the
intelligence gathered will inform the setting of priorities for the HSE
and the monitoring of implementation.
Starting next year it is intended that national patient safety
campaigns directed by priority patient safety areas, for example,
targeting medication errors will take place.
Appointment of a National Advisory Council for Patient Safety
A National Advisory Council for Patient Safety is to be appointed in
early 2016. This Council will have an independent chair, significant
representation from healthcare leaders and from patients.
Membership will be selected through public invitation from the
Public Appointments Services. This Council will provide advice and
guidance to inform the policy direction for the Departments new
National Patient Safety Office in its delivery of three core functions;
patient safety surveillance, patient advocacy and building further
the work of the National Clinical Effectiveness Committee.
The National Advisory Council for Patient Safety will publish
independent patient safety reports to be laid before the Houses of
the Oireachtas. They will be reports, which through the
interrogation of patient safety information will assist the health
service and regulators to recognise the conditions that help predict
whether harm is likely to occur.
Clinical Effectiveness
The National Clinical Effectiveness Committee (NCEC) is a
ministerial committee which was established as part of the Patient
Safety First Initiative. The NCEC is a partnership between key
stakeholders in patient safety.
The NCEC, through its terms of reference, provides a framework
for national endorsement of clinical guidelines and audit to
optimise patient and service user care. High quality guidelines are
the internationally recognised method of directing evidence based
practice and reducing variation of practice, thereby improving
clinical outcomes and patient safety. It is intended, as agreed with
the Director of Clinical Programmes, that the National Clinical
Guidelines will underpin the models of care.
Ten NCEC National Clinical Guidelines have been published to
date and a further four will be published by the end of November.
Progress in Patient Safety
The Department has mandated the HIQA National Standards for
Safer Better Healthcare. These standards provide all healthcare
providers with a blueprint for safe and effective care which places
the patient at the centre of the way care is delivered. The process
of implementation and monitoring against these Standards by the
HSE and HIQA is ongoing.
Earlier this year the National Women & Infants Health Programme
was established to standardise and improve maternity services
across the country. The National Maternity Strategy being
developed will provide the policy to underpin the Women & Infants
Health Programme. The Strategy Steering Group to advise on the
Strategy has continued to meet during 2015 and it is expected that
the Group will report early in December.
A new National Incident Management System called NIMS was
introduced in 2014 and since June 2015 all incidents in the
healthcare sector are now being reported directly on to NIMS. It
facilitates more detailed and consistent reporting of incidents.
In addition a new maternity patient safety statement has now been
introduced in all 19 maternity units. The next phase is to introduce
a patient safety statement across all acute hospitals. These
statements will report monthly on key patient safety trends such as
complaints, sepsis rates etc., will be published regularly by
hospitals and be the basis for on-going patient safety improvement
programmes.
A number of national patient safety guidelines to target
standardised approaches to the management of clinical
deterioration, clinical handover and sepsis have been published by
the National Clinical Effectiveness Committee and are in the
process of being fully implemented in the health service.
An Oversight Group has been established chaired by the Chief
Medical Officer of the Department to oversee, report on and
highlight the extent of progress being made on the implementation
of the HIQA Portlaoise recommendations.
The Department has recently completed work on the development
of a Code of Conduct for Health and Social Service Providers that
clearly sets out employers responsibilities in relation to achieving
an optimal safety culture, governance and performance of the
organisation.
ENDS
Patient-Safety-Conference-12.11.2015 Cross Departmental Approach
to Tort Reform and Legislation The Government has given its
approval to the drafting of provisions to support Open Disclosure of
patient safety incidents.
http://health.gov.ie/wp-content/uploads/2015/11/Patient-Safety-
Conference-12.11.2015.pdf
Commencement of the Misuse of Drugs (Amendment) Act 2016 and
associated Ministerial Regulations and Orders On 2 May 2017
http://www.irishstatutebook.ie/eli/2016/act/9/enacted/en/pdf
Changes to the Form of Prescriptions and Supply on Prescription
(previously Regulations 13 and 14 of the 1988 Regulations, now
Regulation 15 and 16 in the 2017 Regulations)
http://health.gov.ie/wp-content/uploads/2017/05/Changes-to-the-
prescription-requirements-for-controlled-drugs.pdf
Schedule 4 Part 1 Controlled Drugs in the Misuse of Drugs
Regulations 2017
http://health.gov.ie/wp-content/uploads/2017/05/Schedule-4-Part-1-
Controlled-Drugs-in-the-Misuse-of-Drugs-Regulations-2017.pdf

Recommended composition of influenza virus

vaccines for use in the 2016- 2017 northern
hemisphere influenza season

http://www.who.int/influenza/vaccines/virus/recommendations/2016
02_recommendation.pdf?ua=1
Food and Drug Administration Center for Biologics Evaluation and
Research SUMMARY MINUTES VACCINES AND RELATED BIOLOGICAL
PRODUCTS ADVISORY COMMITTEE March 4, 2016
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMe
etingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelated
BiologicalProductsAdvisoryCommittee/UCM494071.pdf
licensed influenza vaccines and changes to the licensed indications for
existing vaccines, ACIP relies on FDA, which has regulatory authority for
review of safety, immunogenicity, and effectiveness data and licensure of
influenza vaccines.
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/Ap
provedProducts/UCM474387.pdf
September 9, 2016 Approval Letter Correction FLUAD
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/Ap
provedProducts/UCM523222.pdf
Indicated for active immunization of persons 65 years of age and
older against influenza disease caused by influenza virus subtypes A
and type B contained in the vaccine.
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/Ap
provedProducts/UCM474387.pdf

Type of Vaccine Ingredients Concern- There seem to be too many

ingredients in vaccines that could harm my child.
http://www.michigan.gov/documents/mdch/Waiver_Ed_Ingredients_4
79931_7.pdf
Influenza (Flu) Vaccine (Inactivated or Recombinant)- What you need
to know
https://www.cdc.gov/vaccines/hcp/vis/vis-statements/flu-
largetype.pdf