Gardasil and Cervarix - The Cervical Cancer Vaccines
THE NEW HPV VACCINE – Miracle or Menace?
Human Papilloma Virus is what doctors believe is responsible for triggering cervical cancer in women, some forms of genital warts and vulval intraepithelial neoplasia (VIN). A new experimental vaccine called Gardasil is being developed against 4 types of HPV, 2 of which are thought to cause 70% of cervical cancers.
However, HPV is extremely common and is present in upto 80% of people by the time they are 50, and it rarely develops into cancer. Cancer will only develop if the person is already in a state of dis-ease.
‘HPV, by itself, does not kill anyone. According to the Daily, 5,000 people die of HPV each year. However, according to the National Institute of Health (NIH), this is
the number of women who die from cervical cancer in the United States. Also,
there are over 100 strains of HPV, 30 of which are transmitted sexually, and
only two of which are pre-cancerous. It is only those two strains that are
responsible for most cases of cervical cancer….but that rate for cancer is actually very low.’ ( Letter to the Stanford Daily, February 10, 2006).
What Is VIN?
As a woman who has suffered since the age of 12 with a vulval pain syndrome, I myself was recently suspected of having VIN, which is a pre-cancer of the vulva. After living with my vulval disorder for 17 years, and reading everything I can about these conditions, I can tell you that VIN isn’t cancer. It is simply abnormal cells in the vulva which MAY potentially develop into cancer.
According to the Vulval Pain Society, ‘We use the word pre-cancer, NOT because the cells are cancerous or you have cancer, but because the cells MAY (or MAY NOT) develop into cancer over a period of years. The exact relationship between VIN and vulval cancer remains unknown because so few studies have been done…..Very little is known about women with VIN I or II. The VPS has recently been contacted by a vulval pain sufferer whose consultant gynaecologist told her that, according to new research, neither VIN I nor VIN II exist. We hope to post further research findings..’
The most common form of treatment for this is to do nothing and wait and see, as most people with abnormal findings do not develop cancer.
It hardly seems worth having a vaccine, with these incredibly low risks.
The cancer vaccine that GIVES you cancer
The new vaccine was tested on both males and females, but is expected to be used primarily against cervical cancer. Five women involved in the tests, gave birth to children with birth defects, as they were vaccinated near to conception of their babies. The plan is to vaccinate girls aged 9 to 12 who are not yet sexually active, but the FDA is also considering recommendations of whether to give the vaccine to 13-26 year old’s. If the vaccine is given to this age group, there is no guarantee that should a pregnancy occur, the foetus would not develop birth defects and abnormalities.
There have also been no long term studies into fertility and whether or not vaccinating young girls with HPV would have any affect on their future ability to have children.
Another concern the FDA have is that the vaccine may pre-dispose women to cancer if they already have traces of HPV in their body (as most people do!).
Also, the vaccine is only meant for 4 types of HPV, and there are many other types the vaccine does not cover, which can still cause disease. I can imagine this being a useful excuse for doctors in the event of vaccine caused cancer. They could simply say that the jab didn’t protect against the strain of cancer you’ve got, rather than admitting the jab had pre-disposed you to getting it.
"If it works, it's great; if it has side effects we don't yet know about, it could be bad," said Dr. George Davis, a physician at the Callan Family Care Center in Copake, "Although it has been tested for FDA approval, we sometimes don't know all of the side effects until a certain amount of time has passed," he said. (indenews.com).
Other side-effects reported are: Pain (83.9%), swelling (25.4%), erythema (24.6%), fever (10.3%) and pruritis (3.1%).
The Merck press release where I obtained details of side-effects, also states that ‘GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine’, but failed to state on this particular release, what those ingredients are. Most parents, as a general rule, do not think to ask for a list of the ingredients prior to their children being vaccinated, so it would not be known if a child was contraindicated until after the event.
Basically they will be testing on the nation’s daughters, without adequate knowledge of the possible sequelae that could arise from that.
There are also suggestions of targeting black African women, on account of them having a slightly higher rate of cervical cancer. It seems reminiscent to the Hepatitis B vaccine campaigns of the 1970’s on black and gay people, after which AIDS swept through these communities.
I searched for manufacturer's information on the drug and managed to find the following from Hall Health Primary Care Center in Seattle, USA:
Ingredients: The main ingredients are purified inactive proteins that come from HPV Types 6, 11, 16 and 18. The vaccine also contains amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.
Effectiveness: The length of vaccine protection (immunity) is usually not known when a vaccine is first introduced. So far, studies have found that vaccinated persons are protected for five years. More research is being done to find out how long protection will last, and if a booster dose of vaccine will be needed.
Contraindications (reasons you should not have the vaccine):
Who should not receive the HPV vaccine?
· is allergic to any components of the vaccine
· has an allergic reaction after getting a dose of the vaccine
What are other possible reasons that patients cannot receive this vaccine?
It is very important that patients let their provider know if they have had any of the following before receiving the HPV vaccine:
· allergic reaction to the vaccine
· bleeding disorder such that the patient cannot receive vaccines in the arm
· weakened immune system
· pregnant or planning pregnancy
· current illness with a fever greater than 100 degrees Fahrenheit
Just Who Owns Your Child’s Body?
Your child herself and you as parental guardian, or the government?
Doctors at Brown Medical School, Miriam Hospital, US, are pushing for HPV vaccines to be mandated.
‘"Parental consent ought to be waived for HPV vaccination as it is for other sexually transmitted infection-related health care." (The Lancet, Infectious Diseases, July 2005).
No further explanation as to why is offered.
Does the Vaccine Even Work?
As well as heightening the risk of cancer in women with HPV already present in their bodies, the CDC say that tests show the vaccine will ‘protect’ for just 4 years. No long-term results are known yet. This means repeat doses will be needed regularly throughout adult life. The initial vaccination is also not just one shot, but three, given over a period of 6 months, so this whole course would have to be done again after the 4 years was up.
The CDC state that:
‘The vaccine only prevents infection but cannot prevent the disease once a person is already infected. They urged women to remain vigilant. "The vaccine should not take the place of a yearly exam and pap smear,"
As the Hall Health Primary Care Center stated, they don't know if the vaccine works and even if it did, only for a maximum of 5 years.
Men also carry HPV and can pass it onto others through sexual contact, so there is a question mark over whether they should be vaccinated too.
There are also ethical dilemmas over whether gynaecologists or paediatricians should be administering the shots since the vaccine is aimed at girls not yet sexually active.
Many paediatricians are uneasy about injecting a vaccine for cervical cancer and sexually transmitted genital warts, into children.
So the plan is to vaccinate your daughter by force with a jab whose side-effects are unknown, that has caused birth defects in clinical trials and that has the potential to pre-dispose her to cancer, with absolutely no regard for choice or whether parental consent has been given, and without even accurate indication or long term studies to suggest it even works.
Why would the medical profession take such risks?
Certainly not for your daughter’s benefit!
Jean Stephenne, vaccines head at GlaxoSmithKline PLC, said he was particularly excited by experimental vaccines to prevent infection by the human papilloma virus (HPV) that causes cervical cancer.
Both Merck and GSK have HPV vaccines in development that will compete in a market that Stephenne estimated would eventually be worth some $3 billion pounds a year. His company takes a 24% share of the $6.5 billion a year global vaccine industry.
Most of this money is being fuelled by new combination jabs, such as the 5-in-1, and new jabs for adolesants and adults, such as flu shots and the new HPV vaccine. (Reuters, Ben Hirschler, European Pharmaceuticals Correspondent).
They stand to make a LOT of profit from your child, even if that shot carries risks, they are risks the drug companies don’t mind making.
The question is, do YOU?
Update To Article - 6th May 2008
The FDA's VAERS database now shows more than 1,637 adverse events associated with the vaccine since it was introduced to the US in June 2006. This figure is just for America and does not include UK adverse reactions. Of these, there were 371 serious adverse reactions and 3 deaths.
In one report, a girl died just three hours after getting a Gardasil vaccine when she developed a blood clot. Two other girls, aged 12 and 19 also died after vaccination when they developed blood clotting and heart problems.
Other serious reports included paralysis, Bell's Palsy, Guillain-Barre Syndrome and seizures. Of 42 pregnant women who were vaccinated, 18 of them developed complications, mainly miscarriages, and one gave birth to a deformed baby. Indeed, during the clinical trials of the vaccine, 5 women who got pregnant within 30 days of having the vaccine, gave birth to children with abnormalities.
In the UK there have also been two girls die within hours of having the jab, bringing into question its safety.
Editors Comment: What if a teenager or young woman has the vaccine and then gets pregnant? Surely this is a medical timebomb waiting to happen, just like with thalidomide?
Further Update - 13 June 2008
Gardasil is only licenced for use in females aged between 9 and 26 years old. Yet 14 of the VAERS reports were for children younger than 9 and there were 73 adverse event reports for those older than 26. These people should not have been given the vaccine!
Cervical Cancer Vaccine Given To Baby Boys!?!
According to VAERS ID number 273751, a three month old baby boy was vaccinated with Gardasil and had fever, rash and vomiting as a result.
There were 15 other VAERS reports for male patients.
Male Adults Also Given Cervical Cancer Vaccine
Here are some more cases:
VAERS ID 263231: 18 year old male experienced joint pain and fever after the shot.
VAERS ID 278506: 18 year old male experienced dizziness, nausea, vomiting and fatique after the shot.
VAERS ID 279599: 45 year old male got a rash over his entire body after the shot.
VAERS ID 271136: 53 year old male experienced nausea, dizziness and weakness which lasted in excess of six weeks after the shot.
Editor's Comment: Baby boys and men vaccinated for cervical cancer when they don't even have a cervix? It's hard to take the 'immunisation' programme seriously or to believe that these people are supposed to be an 'authority' on our health!
What Does The Inventor of HPV Vaccine Have To Say?
Professor Ian Frazer, inventor of the vaccine, had this advice to give to parents:
"Everybody has the right to say no, that is their right but they also have the right to get cervical cancer and they also have the right to die, it goes with the territory.'
Methinks he needs to see a therapist :) He's so dramatic and emotional. What ever happened to calm and rational argument?
Used As A Guinea Pig For Gardasil
She loved SpaghettiO's, pepperoni, lilies, listening to her iPod and making her pals laugh.
In her senior yearbook, she wrote, "The best things in life aren't things, they're friends."
Now that's the quote chiseled into her gravestone.
Jessica Ericzon, 17, was "an all-American teenager," as described by one of her upstate LaFargeville teachers.
Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother.
Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom.
It started with a pain in the back of her head.
On the advice of her family doctor, Jessie had taken a series of three Gardasil shots.
The vaccine, marketed for females ages 9 to 26, is the first found to ward off strains of the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer.
Jessie got the first injection in July 2007.
After her second shot in September, she complained of a pain in the back of her head, fatigue and soreness in some joints, said her mom, Lisa.
On Feb. 20, while on winter break from school, she got her third and final dose of the vaccine.
The next night, "she told me the spot on the back of her head was bothering her again," her mom said.
The next morning, Feb. 22, Lisa, a hospital technician, left for work just after 5 a.m., leaving Jessie asleep.
Jessie never showed up for the class she was taking at Jefferson Community College.
When her mom got home at 3:20 p.m., she found Jessie sprawled on her back on the bathroom floor, with blood spots on her head where it had hit a flowerpot.
Jefferson County Medical Examiner Samuel Livingstone is stumped.
"She was essentially dead by the time she hit the floor. Whatever it was, it was instantaneous," Livingstone said. His autopsy found no cause.
He speculates she suffered a cardiac arrhythmia, or irregular heartbeat, extremely rare in young people.
Jessie had been on birth-control pills for a year to treat acne, records show.
Livingstone reported Jessie's death to the federal Vaccine Adverse Events Reporting System.
Run by the FDA and the Centers for Disease Control and Prevention, it has collected 8,000 reports of problems after Gardasil shots, including paralysis, seizures and miscarriages.
Seventeen other deaths following the vaccine have been reported since Merck & Co. introduced it in 2006.
Officials have confirmed 11 of the reported deaths so far, said CDC spokesman Curtis Allen.
They have found "no pattern or connection" to Gardasil in eight deaths and are still reviewing three, he said.
Lisa Ericzon now feels her daughter was "a guinea pig" for Gardasil, and is urging parents to research the vaccine before letting their daughters get it.
"I want other mothers to know," said Lisa, the first parent of a girl who died after Gardasil to speak publicly.
"I don't want them to go through what I went through."
Jessie planned to major in psychology at SUNY Plattsburgh and pursue her greatest ambition - to become a New York state trooper.
Just six days before she died, she got to ride along with a trooper canine unit. She was ecstatic.
Her family started the Jessica Ericzon Memorial Fund to award scholarships to her classmates.
By Susan Eldelman, The New York Post, 21 July 2008.
Cervarix Vaccine - The UK's Version of Gardasil
More than 1 in 10 doses may cause pain, redness and swelling at the injection site, headache, aching muscles and muscle weakness, and tiredness.
More than 1 in 100 doses may cause nausea, vomiting, diarrhoea, abdominal pain, itching, red skin rash, hives, joint pain and high fever.
More than 1 in 1000 doses may cause upper respiratory tract infection, dizziness, a hard lump at the injection site, tingling or numbness.
If the side-effects get serious or you have an affect not mentioned in this leaflet, tell your doctor.
According to a GlaxoSmithKline UK electronic medicines compendium document dated 24 September 2007, subjects in the trial of this product were only monitored for side-effects for 30 days and any occuring after this time were not included in the study.
This vaccine has not been studied to see if it is safe to have during or immediately before pregnancy. It is not known whether the vaccine is excreted in human milk and there have been no studies on its interaction with other drugs (they don't know whether it is safe to have alongside other medicines).
Cervarix is for use against two types of Human Papillomavirus, thought to cause 70% of sexually transmitted cervical cancers. It will NOT protect you against all types of HPV. Duration of 'protection' after vaccination is unknown, but thought to be 5.5 years. So if a 12 year old is vaccinated, it may have worn off by the time she's 17. The need for booster doses has not been studied.
Two types of HPV Virus (16 and 18)
AS04 (aluminium salts and monophosphoryl liquid to make you produce antibodies)
sodium dihydrogen phosphate dihydrate
Virus like particles from the Trichoplusia ni insect (the cabbage looper)
People who should not have Cervarix vaccine:
Those who are allergic to the ingredients of the vaccine (allergic reactions include those listed in the side-effects and swelling of the face, difficulty breathing etc.)
Those with a severe infection or high temperature
Special care should be taken if you have a bleeding disorder or any kind of immunosuppression such as HIV or cancer.
If you are taking other medications, the safety of this vaccine has not been evaluated.
If you are sexually active, the safety of this vaccine is not known in unborn babies. If a girl or young woman gets pregnant during a course of injections, these should be stopped.
The cabbage looper, from which they have taken 'virus like particles' for use in the Cervarix vaccine
Dr. Diane Harper Says Cervarix Is An Experiment As Scottish Ministers Refuse To Allow The Vaccine
Mass vaccination with Cervarix vaccine has been delayed in Scotland.
Dr. Diane Harper, director of the Gynaecological Cancer Research Group at Dartmouth Medical Center in the US, who in fact was paid by GlaxoSmithKline, the manufacturer's of the shot, to conduct safety trials, says there's no proof the vaccine is safe and that safety trials of the Cervarix vaccine should have been conducted for at least four more years before the decision was taken to give the jabs to thousands of girls in schools.
Harper believes the safety tests for side effects should have been conducted for at least a decade and doses given to millions of individuals around the world before any mass vaccination began. She described the cervical cancer vaccination scheme in Scotland as an "experiment".
"We can't tell you it's 100% safe because we don't know that. I think we would have been better waiting.'
Source: News.Scotsman.com, 2nd November 2008.
VAN UK's Comment: In an electronic medicines compendium document that we read, dated 24 September 2007, it stated that safety monitoring for Cervarix was only conducted for 30 days, not months or years. This document has now been updated to 2nd September 2008 and now says that girls were followed for side-effects for the duration of the study, but several thousand of these individuals were not followed for more than 30 days:
'In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.'
http://emc.medicines.org.uk/ and type in Cervarix to find both this document and GlaxoSmithKline's data sheet.
Gardasil Has Caused 78 cases of Genital Warts Including 3 in School Children
Earlier this year the Watchdog Judicial Watch reported that from information they obtained from the FDA under the freedom of information act - there have been 9749 adverse reactions to Gardasil vaccine and 21 deaths.
Also reported were 27 life threatening cases and 10 miscarriages. There have also been 78 cases of genital warts including 3 cases in primary aged children.
In Fiji, Ragogo writes, “Effectively, Cabinet approved a vaccine which is still being tested so no one can be sure of its effectiveness or long-term side effects. Our children are guinea pigs for a money-making, I mean, drug-making, machine.”
In a television interview with CBS News in May, Dr. Diane Harper, the specialist who helped develop the Gardasil vaccine, said making the vaccination mandatory is “a real danger zone.”
“The vaccine has not been out long enough for us to have post-marketing surveillance to really understand what all of the potential side effects are going to be,” Harper said. “To put in place a process that says you must have this vaccine means that you must be part of a big public experiment and so we can't do that. We can't have that until we have more data.”
Source: LifeSiteNews.com 18 November 2008.
Editor's Comment: This article makes me feel truly sick. The idea that little primary aged children are getting genital warts when they are years off ever having sex just makes me ill.
It is a very good reason not to give children vaccines for sexually transmitted diseases
MHRA Government Reports Of Adverse Reactions After Cervarix Vaccine
This information comes from the Medicines and Healthcare Products Regulatory Agency of the UK Government.
Suspected Adverse Reaction Analysis
CERVARIX Human papillomavirus (HPV) vaccine
04 December 2008
This report summarises the adverse reactions suspected to have been caused by Cervarix human
papillomavirus (HPV) vaccine in the UK. This includes reports received between 14 April 2008 and 3rd
December 2008. These reports have been voluntarily submitted to the MHRA by healthcare
professionals and members of the public via the Yellow Card Scheme (visit www.yellowcard.gov.uk)
and by the manufacturers of the vaccine as part of their legal requirements
It is essential to bear in mind that reports to the MHRA relate only to adverse medical events which the
reporter considered could have been caused by the vaccine (i.e. if there was merely a suspicion of
causality). Therefore, cases may be true side-effects or they may have been purely coincidental events
due to underlying or undiagnosed illness that would have occurred anyway in the absence of
vaccination. Events may also have been psychogenic1 in origin. This report therefore cannot be
considered to represent a list of known side-effects of the vaccine. These data also cannot be used to
determine the frequency, or incidence, of known side-effects because they are often under-reported.
The known side-effects, and their frequencies (based on clinical trial data), are available in the product
information (see http://emc.medicines.org.uk/).
The reactions in this report have been broken down into 5 categories based on scientific assessment of
the cases by MHRA assessors: injection-site reactions; allergic reactions; ‘psychogenic’ events; other
recognised reactions; and ‘suspected adverse reactions not currently recognised’ (reactions in this latter
category are divided into the high-level classification of System Organ Class)2.
A single report may contain more than one reaction, more than one sign or symptom of a single
reaction or reactions in more than one of the above categories. Therefore the total number of listed
reactions is greater than the total number of reports and total reports in each of the 5 tables should not
be added together.
To date, the vast majority of suspected adverse reactions reported to MHRA in association with
Cervarix vaccine have related either to the signs and symptoms of recognised side effects listed
in the product information or were due to the injection process and not the vaccine itself (i.e.
‘psychogenic’ in nature).
For the isolated cases of other medical conditions reported, the available evidence does not
suggest that the vaccine caused the condition and these may have been coincidental events.
The balance of risks and benefits of Cervarix remains positive.
1 For this analysis, defined as non-allergic events which occurred within minutes of, or soon after, vaccination and were
most likely a psychogenic response to, or anticipation of, the injection. These are not side effects to the vaccine as such
and can occur with any needle injection procedure.
2 Using MedDRA terminology
SUMMARY OF UK SAFETY EXPERIENCE
Total number of reports received: 623
Total number of suspected reactions: 1416
Estimated number of doses administered to date: unavailable at present
Overall adverse reaction reporting rate: unavailable at present
A. Injection-site reactions
Injection-site reactions including redness, pain and swelling are recognised side-effects of Cervarix
vaccine and are listed in the product information. These may occur at a frequency3 of more than 1 in 10
persons vaccinated. The reported cases of ‘Pain in extremity’ mainly relate to a sore arm.
The cases reported to the MHRA during use of the vaccine in the UK do not indicate any change in the
severity or nature of injection-site reactions.
Reported event (Preferred Term2) Number of cases
Pain in extremity 36
Injection site erythema 15
Limb discomfort 13
Injection site pain 10
Injection site swelling 10
Oedema peripheral 8
Injection site reaction 5
Skin discolouration 4
Injection site rash 3
Local swelling 3
Rash macular 3
Feeling hot 2
Injection site mass 2
Injection site pruritus 2
Musculoskeletal stiffness 2
Injection site induration 1
Injection site inflammation 1
Injection site joint pain 1
Injection site papule 1
Injection site vesicles 1
Injection site warmth 1
Limb immobilisation 1
Local reaction 1
Total reactions 141
Total reports 106
3 Based on clinical trial data
B. Allergic reactions (including skin reactions not directly related to an injection-site
Allergic reactions are recognised side-effect of Cervarix vaccine and are listed in the product
information. These may occur at a frequency4 between 1 in 10 persons (for non-serious types of allergic
reaction such as rash and itching) to less than 1 in 10,000 persons vaccinated. Severe allergic
reactions are very rare.
The cases reported to the MHRA during use of the vaccine in the UK do not indicate any change in the
severity or nature of allergic reactions.
Reported event (Preferred Term2) Number of cases
Swelling face 9
Lip swelling 7
Oedema peripheral 7
Rash pruritic 7
Eye swelling 6
Rash generalised 4
Anaphylactic reaction 3
Paraesthesia oral 3
Throat tightness 3
Eye pruritus 2
Ocular hyperaemia 2
Pharyngeal oedema 2
Pruritus generalised 2
Chest discomfort 1
Eyelid oedema 1
Gingival swelling 1
Limb discomfort 1
Musculoskeletal stiffness 1
Neck pain 1
Pain of skin 1
Peripheral coldness 1
Rash erythematous 1
Rash macular 1
Skin inflammation 1
Swollen tongue 1
Type I hypersensitivity 1
Total reactions 144
Total reports 86
C. ‘Psychogenic’ events
Psychogenic events including vasovagal syncope, faints and panic attacks can occur with any injection
procedure, not just vaccination, and can be common in adolescents. These are due to fear and/or
anticipation of the needle injection and are not side-effects of Cervarix vaccine as such. Such events
can be associated with a wide range of temporary signs and symptoms including loss of consciousness,
vision disturbance, injury, limb jerking (often misinterpreted as a seizure/convulsion), limb numbness or
tingling, difficulty in breathing, hyperventilation etc.
The events in the list below were considered ‘psychogenic’ in nature based on MHRA assessment of
the individual case details reported. The reported cases which do not refer specifically to vasovagal
syncope, faint or panic attack (e.g. convulsion, transient blindness which refers to temporary loss of
vision at the start of a faint) were concurrently reported as signs or symptom of the psychogenic event;
i.e. these also were not side-effects of the vaccine itself.
Reported event (Preferred Term2) Number of cases
Cold sweat 13
Syncope vasovagal 9
Feeling hot 8
Vision blurred 7
Loss of consciousness 6
Unresponsive to stimuli 6
Abdominal pain upper 4
Feeling cold 4
Feeling of body temperature change 4
Visual impairment 4
Abdominal pain 3
Blindness transient 3
Eye rolling 3
Heart rate increased 3
Muscle twitching 3
Muscular weakness 3
Chest discomfort 2
Confusional state 2
Feeling abnormal 2
Muscle rigidity 2
Peripheral coldness 2
Pulse abnormal 2
Rash macular 2
Stomach discomfort 2
Altered state of consciousness 1
Body temperature increased 1
Burning sensation 1
Chest pain 1
Colour blindness 1
Deafness transitory 1
Dizziness postural 1
Dry mouth 1
Dry throat 1
Ear pain 1
Eye swelling 1
Eyelid oedema 1
Facial spasm 1
Feeling of despair 1
Grand mal convulsion 1
Heart rate irregular 1
Hot flush 1
Lip swelling 1
Musculoskeletal stiffness 1
Neck pain 1
Oropharyngeal pain 1
Panic reaction 1
Rash generalised 1
Respiratory arrest 1
Respiratory rate decreased 1
Respiratory rate increased 1
Salivary hypersecretion 1
Seizure anoxic 1
Sensory loss 1
Swelling face 1
Throat irritation 1
Throat tightness 1
Total reactions 540
Total reports 205
D. ‘Other recognised’ reactions
This section includes other events recognised to be side-effects of Cervarix vaccine and not already
included in sections A and B above. This also includes signs and symptoms of recognised side effects.
The frequencies, where known, are listed in the product information.
The cases reported to the MHRA during use of the vaccine in the UK so far do not indicate any change
in the severity or nature of these reactions.
Reported event (Preferred Term2) Number of cases
Abdominal pain upper 18
Abdominal pain 10
Feeling hot 5
Stomach discomfort 5
Body temperature increased 3
Oropharyngeal pain 3
Pain in extremity 3
Back pain 2
Feeling of body temperature change 2
Influenza like illness 2
Musculoskeletal stiffness 2
Neck pain 2
Local swelling 1
Lower respiratory tract infection 1
Musculoskeletal chest pain 1
Nasal congestion 1
Pruritus generalised 1
Respiratory disorder 1
Skin warm 1
Upper respiratory tract infection 1
Total reactions 472
Total reports 252
E. Suspected adverse reactions not currently recognised
This section includes reports which, based on MHRA assessment of the case details provided, do not fit
into one of the above 4 categories.
These suspected ADRs are not currently recognised as side effects of Cervarix vaccine and the
available evidence does not suggest a causal link with the vaccine. These are isolated medical events
which may have been coincidental with vaccination. These reports are continually assessed by the
System Organ Class Reported event (Preferred Term2) Number of cases
Blood and lymphatic
system disorders Lymphadenopathy 4
Cardiac disorders Palpitations 1
Ear and labyrinth
disorders Ear pain 3
Eye disorders Eye swelling 1
Vision blurred 3
Gastrointestinal disorders Abnormal faeces 1
Mouth ulceration 1
General disorders and
Feeling cold 1
Influenza like illness 5
Local swelling 1
Oedema peripheral 2
Peripheral coldness 2
infestations Application site pustules 1
Pneumonia viral 1
Injury, poisoning and
procedural complications Contusion 3
Drug exposure during pregnancy 1
Investigations Blood glucose increased 2
Blood pressure increased 1
Respiratory rate increased 1
Weight decreased 1
Metabolism and nutrition
disorders Anorexia 1
Diabetes mellitus inadequate
Diabetic ketoacidosis 1
Muscular weakness 2
Musculoskeletal stiffness 1
Pain in extremity 5
disorders Complex regional pain syndrome 1
Facial palsy 1
Grand mal convulsion 1
Status epilepticus 1
Unresponsive to stimuli 1
and perinatal conditions Abortion spontaneous 1
Psychiatric disorders Confusional state 1
Sleep disorder 2
Reproductive system and
breast disorders Amenorrhoea 1
Respiratory, thoracic and
mediastinal disorders Asthma 1
Nasal congestion 1
Oropharyngeal pain 3
Skin and subcutaneous
tissue disorders Eczema 2
Guttate psoriasis 1
Rash vesicular 1
Skin discolouration 2
Vascular disorders Flushing 1
Total reactions 119
Total reports 71
In relation to safety in pregnancy, during pre-licensing studies of Cervarix it was found that almost
870 women became pregnant before or after receiving the vaccine. The overall rates of
spontaneous abortion in these clinical trials were no greater than the background rates in the
general population (i.e. regardless of vaccination). There is currently no evidence to suggest that
Cervarix vaccine carries any risks during pregnancy. Nonetheless, Cervarix is not recommended
for use in pregnancy.
Spain Withdraws Batch Of Gardasil Vaccine
Spanish health authorities have withdrawn tens of thousands of doses of a vaccine against cervical cancer after two teenagers who received the shots were hospitalised, regional authorities said on Tuesday.
A batch of nearly 76,000 doses of the human papillomavirus vaccine (HPV) was withdrawn from market, a government statement said, after two girls in the eastern Valencia region fell seriously ill hours after receiving them.
"One of the girls got out of intensive care this weekend and the other is still there. Both are in stable condition," a Valencia health department spokeswoman told AFP.
The two girls were vaccinated last week as part of a vast government vaccination programme targeting adolescents.
Source: Yahoo News, 10 February 2009.
VAN UK'S Comment: I find it interesting that Spain withdraws the vaccine after 2 girls fall ill, yet we have a girl paralysed in this country and 29 deaths so far in the States, and no one has done anything.
Over 1,300 Girls Suffering Serious Side-Effects From Cervarix Vaccine
More than 1,300 schoolgirls have experienced adverse reactions to the controversial cervical cancer jab.
Doctors have reported that girls aged just 12 and 13 have suffered paralysis, convulsions and sight problems after being given the vaccine.
Dozens were described as having pain 'in extremity' while others suffered from nausea, muscle weakness, fever, dizziness and numbness.
But Government health experts insisted the Cervarix vaccine was safe and that the total of 1,340 reports was to be expected, given that more than 700,000 girls were vaccinated last year.
They also said many of the reactions resulted from the act of injection rather than the vaccine, and said there was no evidence that the jab caused any of the serious conditions such as paralysis.
Reports of adverse reactions to drugs and vaccines are collated by the drug safety watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), from reports by doctors.
Their latest analysis found there had been 1,340 reports in total, with 2,891 different adverse effects noted. Most were minor complaints such as rashes, swelling on the injection site, pain or allergic reactions.
But there was a range of more worrying problems. Four girls had convulsions, one had a seizure and one had an epileptic fit.
There were several cases of paralysis. One had Bell's palsy, which paralyses the face; one had hemiparesis, which paralyses or severely weakens half the body; two experienced hypoaesthesia, in which the sufferer loses much of her sense of touch, and one had Guillain-Barré syndrome, which paralyses the legs.
There were almost 20 cases of blurred vision and one girl was reported as developing anorexia.
Source: Mail Online, 9th March 2009.
VAN UK'S Comment: Over 1,300 serious reactions out of 700,000 girls is not rare, and not an acceptable risk. To say that paralysis is not caused by the vaccine is ridiculous. They must assume parents are stupid.
A healthy 12 year old doesn't just become paralysed. Serious reactions after vaccination are usually dismissed as coincidence, even in medical trials
Information About The Safety Trial of Gardasil
Dr. Diane Harper was a lead researcher in the development of the HPV vaccine Her HPV-vaccine trial papers were amongst the first I found when I started researching Gardasil. In 2004 Dr. Harper was excited about the the possibilities for the HPV-vaccine. By March, 2007 she had become an out spoken, and often quoted critic of Merck’s HPV-vaccine Gardasil and how it was being marketed to the American public. She has expressed that neither Merck, CDC nor the FDA have been forthright about the trials prior to vaccine licensure of Gardasil June 2006.
Merck’s clinical trials did not prove the human papillomavirus (HPV) vaccine, designed to prevent cervical cancer and genital warts, is safe to give to young girls. Merck and the FDA do not reveal in public documents exactly how many 11 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were fewer than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.
The study consisted of 2,392 young women. 36 percent were disqualified primarily because they had detectable HPV markers before the trial. The study was selected for women who showed some sort of robust natural immunity that kept them from expressing the HPV markers. 859 were excluded from the final data analysis for technical reasons and the vast majority were found to be infected with HPV-16 before getting the vaccine.
Of 1,533 women who remained, half were given the vaccine and half the placebo shot. The placebo used contained a potentially reactive aluminum and a non-reactive saline solution. A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial.
Animal and human studies have shown that aluminum adjuvants can cause brain cell death and that vaccine aluminum adjuvants can allow aluminum to enter the brain, as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. Nearly 90 percent of all Gardasil recipients and 85 percent of aluminum placebo recipients reported one or more adverse events within 15 days of vaccination, particularly at the injection site. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.
Fifteen women in the Gardasil group and 16 in the placebo group gave birth to babies with abnormalities. Five of the babies were conceived by women 1 month after they received the vaccine. The rest were conceived by women after 1 month of injection with Gardasil. In the same report, Gardasil was also found to cause an increase in abnormal/precancerous cells in the cervix. It doesn’t take rocket science to intelligently translate that into an increased risk for cervical cancer. Contradictory to Merck’s ad campaign of “one less”, girls taking the vaccines are actually at an increased risk of being one more in the cervical cancer statistics. Of those who received the placebo shot, 41 women became infected with HPV-16, and nine of them had precancerous cervical growths.
Then the study used a cancer detection method which is known to be inaccurate, with a rate of false negative test results that ranges from 1 percent to 93 percent, despite the fact that it is the only test currently available in the United States to screen women for signs of cervical cancer. (A false negative result means that women who have cervical cancer or precancerous tissues are not being identified when they have a Pap smear.)”
The women in this study were only monitored for HPV infection if they show a positive Pap smear. But since even the CDC recognizes that the Pap test produces a wide range of false negative results, the HPV study’s Pap test is so unreliable that the rest of the study is raises much suspicion.
A positive result was defined as any PCR signal that exceeded the background PCR level associated with an HPV-negative sample of human DNA. This is a risky protocol because PCR tests are plagued with false positive reactions (a positive signal that is not a true detection of the target). Since the authors show no data or reference to data on a secondary test that confirms the gene sequence of a positive signal, they cannot conclude that they are measuring HPV.”
According to Merck’s product insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis in 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.
Dr. Diane Harper, a lead researcher in the development of the HPV vaccine has studied the Human papillomavirus for over 20 years. She states that giving this vaccine to girls as young as 11 years old is a “great big public health experiment” and that it has NOT been tested for effectiveness for them. She also says that it will not protect girls at all that are as young as nine years old.
Harper feels the ideal way to vaccinate women is to offer it at 18 years of age. She says these women should be screened for HPV. If the test results are negative then they should schedule the 3 shot series. She admits that if the test comes back positive there is truly no understanding of how to medically respond to that.
“The zealousness to inoculate all these younger girls may very well backfire at the very time they need protection most.” Harper says. “This vaccine should not be mandated for 11-year-old girls,” she reiterated. “It’s not been tested in little girls for efficacy. At 11, these girls don’t get cervical cancer - they won’t know for 25 years if they will get cervical cancer.” Clearly if it has not been tested for efficacy in 11 year old girls, it is neglectful and wrong for CDC and politicians to even suggest [much less recommend] the vaccine to be effective or safe for nine year old girls. Physicians should be careful not to follow in such disgrace by administering the vaccine to these young girls.
“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” Angela Raffle, a specialist in cervical cancer screening with the National Health Service in Britain said “There is no need to rush… If we do this quickly and badly, we could cause more deaths,” from side effects, for example, or from giving girls false security that they are protected for life and no longer need to be screened.
“Also, the public needs to know that with vaccinated women and women who still get Pap smears (which test for abnormal cells that can lead to cancer), some of them will still get cervical cancer,” says Harper.
Merck has not been able to prevent cancer. Not in the trials and not now. Gardasil is not 100% effective against HPV. Harper reminds us that it is only 100% effective against two types of HPV. Those would be the two high risk types [HPV-16 and HPV-18]. The other two [HPV-6 and HPV-11] are low risk and have not been associated with cervical cancer.
In a 1998, study on the Transmission of Cervical Cancer-Associated Human Papilloma Viruses from Mother to Child, posted on the Interviology, Karger.com web site, the authors stated that: “ …HPV have been detected in asymptomatic women, infants and children. Several studies have demonstrated that infants can acquire high-risk HPV infections from their mothers at birth. Thus, the traditional view that cervical-cancer associated HPV infections are primarily sexually transmitted needs to be re-assessed. …the role of mother to child transmission of cancer-associated HPVs may need to be investigated further. These facts are pertinent to those developing prophylactic vaccines to prevent high-risk HPV infections and cervical carcinoma.”
Exposure of HPV to infants and children prior to inoculation; raising concern that the vaccine will be rendered ineffective. In a September 12, 2008 news release, the FDA stated that: “There was no evidence for benefit among women found to have been previously infected, prior to immunization, with the HPV types included in the vaccine. Therefore, to receive Gardasil’s full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine.” If a young girl already has HPV-16 and HPV-18 markers before inoculation, the vaccine will not protect her from infection of those strains. The only way to test for the presence of HPV is to conduct a vaginal swab, which is inappropriate to do with young girls. Merck assumed that because older girls did not show up with HPV markers after inoculation, the young girls (as young as 9 years old) would be protected as well.
Sound science does not run on assumptions.
Clearly, three years of studying the safety and efficacy of a vaccine against a cancer that takes decades to develop is not long enough. There is no science in fast tracking trials or a vaccine for cervical cancer and then presuming safety and efficacy. The third phase of the trial was not even completed before the vaccine was licensed. “There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it,” says Barbara Fisher. “Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls – especially simultaneously with hepatitis B vaccine - will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults. With cervical cancer causing LESS than one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group.“
In June, 2006, after Gardasil’s FDA approval, the CDC’s The Advisory Committee on Immunization Practices (ACIP) recommended the Merck HPV-vaccine as a school attendence requirement for girls. In September, 2006, Michigan was the first US state to propose a bill that would recommend the vaccine for girls registered in the public schools. Utimately, the Michigan legislature voted against manadating the Gardasil vaccine for school girls. Merck was down but not out they still had every expectation for Gardasil mandates from the state governments of Texas, Pennsyvania, Virginia, and Colorado.
Source: Top HPV Researchers Join Those Advising Caution In HPV Vaccines Gardasil And Cervarix Immunization, by H. Sandra Chevalier-Batik, Holy Hormones, Honey! (website for women), 15 May 2009.
Experts Call For Proof That Cervarix And Gardasil Really Work As Claimed
LEADING scientists and doctors have raised fresh concerns about the safety of a cervical cancer vaccine.
They have accused the manufacturers of Cervarix and another jab, Gardasil, of making misleading claims.
More than 1,300 British girls have reported adverse reactions to Cervarix, ranging from paralysis to convulsions and sight problems.
Hailed as a wonder drug, it is claimed the jab will give 70 per cent protection from the disease to every girl under 18 by 2011.
Earlier this month the Sunday Express revealed the story of Rebecca Ramagge, 13, of Reigate, Surrey, who has been unable to walk for six months because of a joint disorder.
Rebecca’s paediatrician blames her condition on Cervarix.
In Germany, 13 distinguished professors have complained that the jab makers, Glaxo SmithKline and Sanofi, have been guilty of giving “incorrect” information.
Professor Martina Doren, of the Charitie Hospital in Berlin, said: “What concerns us is that the two manufacturers of the vaccine aren’t always using facts. They claim that a lot of high-risk strains of cancer-causing virus are protected against but equally there are others that are not.
“If protection is not more than 20 per cent then that is an awful lot of money to be spending, particularly as the vaccines have quite serious side-effects.
“Assertions that a vaccine reduces the risk of cervical cancer by 70 per cent or even 98 per cent should not be made at this point.”
Professor Doren criticised the fact that the only trials for the vaccines were carried out on women aged between 15 and 26 while the vaccine was being given to 12 and 13 year olds.
She said: “It is wrong to vaccinate these girls when it has not been tried on this age group. It is unethical.
“We are meant to be in an era where drugs and vaccines to be used on children are given trials on that age group first before awarding a licence. Otherwise you are experimenting on children, which is wrong.”
Last night a spokesman for the German national vaccines committee told the Sunday Express that a review of the evidence was under way.
Meanwhile in the Netherlands there has been mass resistance to the vaccine with only 49 per cent of girls turning up to have the first jab of the three- injection course.
Six Dutch girls were taken to hospital after being inoculated and there have been reports of more than 500 other adverse reactions.
Doctors there are calling on their national vaccines committee to reconsider its decision to back vaccination of schoolgirls. Many scientists claim the figure of 70 per cent protection against cervical cancer is not based on scientific evidence and has been used to convince parents that their girls ought to have the jab.
Experts in Scotland, where the Health Service has spent more than £64million vaccinating schoolgirls, are also expressing concerns.
Scottish Conservative health spokeswoman Mary Scanlon said: “Given this new research, it is incumbent on the Scottish government and the chief medical officer to review the vaccination programme to ensure that it lives up to the expectations of preventing cervical cancer.”
Last February 80,000 jabs in Valencia and the Balearic Islands were withdrawn after three girls ended up in hospital with convulsions and loss of consciousness within hours of being inoculated.
Source: The Sunday Express, 31st May 2009.
Government Forced To Alter Cervarix Safety Leaflets From 'No serious side-effects were caused by the vaccine', to 'The vaccine meets the rigorous safety standards required for it to be used in the UK'.
THE Scottish Government and Department of Health amended public information leaflets and websites about the decision to vaccinate schoolgirls against cervical cancer after the intervention of a drug company.
Internal documents, released to The Scotsman under Freedom of Information laws, show the extent to which the advice was changed. Sanofi Pasteur MSD, which makes Gardasil – a rival vaccine to Cervarix – said many claims in the initial publicity referred to its own drug and not Cervarix.
Following correspondence, Sanofi's medical director said: "The Department of Health (has] agreed to modify the wording in a number of places... in order not to mislead potential vaccinees and other involved parties."
But according to exchanges between NHS Health Scotland, Health Protection Scotland and the Department of Health, by this point inaccurate information packs had already been sent to healthcare professionals. "(Our] professional pack materials are labelled draft, and have already been distributed. However, this does affect our public materials," says an e-mail from NHS Health Scotland's immunisation co-ordinator.
The Department of Health made a number of proposals to change to the UK-wide advice in the Beating Cervical Cancer leaflet. An e-mail from a member of NHS Immunisation Information to relevant officials across the UK listed two significant changes. In the first one, the original wording "The vaccine has been tested on hundreds of thousands of females aged nine to 26 years around the world with no serious side-effects caused by the vaccine" was changed to: "The vaccine meets the rigorous safety standards required for it to be used in the UK and other European countries."
Another alteration led to the following words: "Hundreds of thousands of young women in the USA and other countries have already had their vaccinations. Studies have shown that the vaccination is very safe" changed to: "The vaccine meets the rigorous safety standards required for it to be used in the UK and other European countries."
Source: news.scotmans.com, 1st June 2009.
VAN UK'S Comment: It's a pity the government didn't amend them in light of so many girls becoming chronically ill. It had to be done because of a competing drug company. Really shows you who runs the show.
6,723 Reactions To Gardasil in USA in 2008 alone
This includes 1,061 'serious' reactions, 142 'life threatening' reactions and 28 deaths.
The deaths have risen from 19 recorded in 2007, and this is just in the US.
Here are some VAERS reports:
* "15 months from the completion of the GARDASIL HPV vaccination, I had full blown cervical cancer. My oncologist would like to do a hysterectomy at this time, but [as I have] always wanted children, I have chosen to wait . . . I have two of the [strains] that the shot is suppose to prevent . . . I now have cervical cancer and I am left wondering what role the GARDASIL HPV vaccination played in the hasty onset." (ID: 319836)
* "After receiving her second dose of GARDASIL … she could crawl but … needed to use crutches or a wheel chair ... She was experienced problems breathing and had ‘super migraines' that never went away … She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice … patient has not recovered from symptoms." (ID: 318052)
* A 19-year-old girl with no medical history immediately experienced side effects after receiving the Gardasil vaccine. Within eleven days her symptoms included "Aggression, Arthralgia, Complex partial seizures, Confusional state, Convulsion, Crying, Dizziness, Epilepsy, Fatigue, Feeling abnormal, Grand mal convulsion, Immediate post-injection reaction, Irritability, Myalgia, Nausea, Pain, Postictal state, Somnolence, Syncope, Tremor, and Unresponsive to stimuli." (ID: 320598)
* "Two weeks after the third dose, the patient developed a complication. She was taken to the hospital by ambulance but passed away during the transport from an unknown cause…Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and patient expired." (ID: 314769)
The FDA VAERS reports show that since last June, 235 cases detailed permanent disability. There were also 29 new cases of Guillain-Barre Syndrome, and 147 cases of "spontaneous abortions," or miscarriages, when the vaccine was given to pregnant women.
Moreover, 62 girls developed warts after receiving the vaccine. This development is of particular concern because Gardasil, which is designed to prevent two strains of genital warts, is not supposed to react with other HPV strains. However, not only did previously healthy women experience genital warts after the vaccination, but 21 girls developed warts on other areas, most commonly the face, hands and feet, and in one case, "all over her body." (ID: 330671)
Of the 47 reported deaths, 41 occurred within a month of receiving the vaccine and of those 17 were within two weeks or receiving the vaccine. In most of the deaths the cause is still unknown.
Source: Judicial Watch, 22nd June 2009.
Doctor Won't Give His Daughters Gardasil Vaccine
Dr. Scott Ratner, a New York cardiologist, will not give his other daughters the HPV vaccine, after one daughter became very ill following the injection.
"If I had to do it again, my wife and I, both physicians, we would not do it," he said.
Wednesday's issue of the Journal of the American Medical Association features a government analysis of 12,424 voluntary U.S. reports of post-vaccination "adverse events," ranging from headaches to death. And a consultant to Merck, which produces the vaccine, has expressed concerns.
Gardasil protects against the four most common types of human papillomavirus (HPV), which is the most common sexually transmitted infection (STI) in the U.S.
Dr. Jennifer Shuford, director of applied science at the Medical Institute for Sexual Health, said the vaccine is relatively new and its long-term effects are not known. She also noted the vaccine does not protect against other STIs.
"We really encourage people to avoid sexual activity before they're in a lifelong, monogamous relationship in order to avoid all of the negative consequences of early sexual activity," she said.
Source: Citizen Link, 27th August 2009.
Researcher Who Developed The HPV Vaccine Says Gardasil Will Not Lower The Rate of Cervical Cancer
Dr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.
Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received.
“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all,” said Joan Robinson, Assistant Editor at the Population Research Institute.
Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.
She went on to surprise the audience by stating that the incidence of cervical cancer in the U.S. is already so low that “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.”
There will be no decrease in cervical cancer until at least 70 percent of the population is vaccinated, and even then, the decrease will be minimal.
Apparently, conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment. Even if 70 percent of women get the shot and required boosters over the same time period, which is highly unlikely, Harper says Gardasil still could not claim to do as much as traditional care is already doing.
Dr. Harper, who also serves as a consultant to the World Health Organization, further undercut the case for mass vaccination by saying that “four out of five women with cervical cancer are in developing countries.”
Ms. Robinson said she could not help but wonder, “If this is the case, then why vaccinate at all? But from the murmurs of the doctors in the audience, it was apparent that the same thought was occurring to them.”
However, at this point, Dr. Harper dropped an even bigger bombshell on the audience when she announced that, “There have been no efficacy trials in girls under 15 years.”
Merck, the manufacturer of Gardasil, studied only a small group of girls under 16 who had been vaccinated, but did not follow them long enough to conclude sufficient presence of effective HPV antibodies.
This is not the first time Dr. Harper revealed the fact that Merck never tested Gardasil for safety in young girls. During a 2007 interview with KPC News.com, she said giving the vaccine to girls as young as 11 years-old “is a great big public health experiment.”
At the time, which was at the height of Merck’s controversial drive to have the vaccine mandated in schools, Dr. Harper remained steadfastly opposed to the idea and said she had been trying for months to convince major television and print media about her concerns, “but no one will print it.”
“It is silly to mandate vaccination of 11 to 12 year old girls,” she said at the time. “There also is not enough evidence gathered on side effects to know that safety is not an issue.”
When asked why she was speaking out, she said: “I want to be able to sleep with myself when I go to bed at night.”
Since the drug’s introduction in 2006, the public has been learning many of these facts the hard way. To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.
Dr. Harper also participated in the research on Glaxo-Smith-Kline’s version of the drug, Cervarix, currently in use in the UK but not yet approved here. Since the government began administering the vaccine to school-aged girls last year, more than 2,000 patients reported some kind of adverse reaction including nausea, dizziness, blurred vision, convulsions, seizures and hyperventilation. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total. The most tragic case involved a 14 year-old girl who dropped dead in the corridor of her school an hour after receiving the vaccination.
The outspoken researcher also weighed in last month on a report published in the Journal of the American Medical Association that raised questions about the safety of the vaccine, saying bluntly: "The rate of serious adverse events is greater than the incidence rate of cervical cancer."
Ms. Robinson said she respects Dr. Harper’s candor. “I think she’s a scientist, a researcher, and she’s genuine enough a scientist to be open about the risks. I respect that in her.”
However, she failed to make the case for Gardasil. “For me, it was hard to resist the conclusion that Gardasil does almost nothing for the health of American women.”
Source: The Bulletin, By Susan Brinkmann, 25 October 2009.
Gardasil Vaccine No Guarantee of Protection Against Cervical Cancer
Women's groups and doctors slammed advertisements issued by two pharmaceutical majors that claimed vaccination against human papilloma virus (HPV) was the best way of preventing cervical cancer.
The objection from Sama Resource Centre for Women and Health and Saheli Women's Resource Centre to Glaxo-SmithKline (GSK) India and Merck marketing HPV vaccines as a "protection against cervical cancer" comes a few days after the Central Drugs Standards Control Organisation (CDSCO) also took notice of the advertisements.
In a showcause notice issued to GSK India, the CDSCO cited objections raised by experts who said that the advertisements claiming that a vaccine can prevent cervical cancer were inaccurate and misleading. According to doctors, the drug majors appear to have oversimplified the complexity of cervical cancer and this could mislead consumers.
Researchers also point out that protection from HPV need not always translate into protection from cancer. "The vaccination doesn't always protect women from cervical cancer because this virus isn't the only cause of cervical cancer," said Dr Sidharth Sahni, a surgical oncology consultant at Artemis Health Institute.
The available HPV vaccines protect against only two types of viruses associated with cervical cancer. "There are several types of HPVs associated with cervical cancer, and vaccines have not been proved to be effective against all of them," said Bhudev Chandra Das, former director of the Institute of Cytology and Preventive Oncology and now a professor of biomedical research at Delhi University.
Ideally, the HPV vaccine should be administered to adolescent girls. Over the past year, paediatricians across the country have been urging parents of teenagers to administer them this vaccine.
But what many fail to mention is that this should only be given to those who have had no sexual exposure. "We first need to identify the target group for this vaccination," Sahni added.
Vani Subramaniam of Saheli said the pharmaceutical companies were hiding information about the side effects of the vaccines. According to Anjali Shenoy of Sama, the health lobby should concentrate more on increasing awareness on screening the cancer rather than its vaccines.
Source: India Today, 29 December 2009.
Blindness After HPV Vaccine
Mirna Hajjar, MD
Department of Neurology at Hartford Hospital, Hartford, Connecticut
Thomas Ciesielski, MD
Department of Pathology at Hartford Hospital, Hartford, Connecticut
We report the course of a 16-year-old girl who presented with near complete visual loss associated with chiasmal neuritis and a biopsy proven tumefactive demyelinating lesion on magnetic resonance imaging (MRI) in association with a recent immunization against human papilloma virus.
Doctors Concerns about HPV Vaccine - India
October 1, 2009
Subject: Concerns around the Human Papilloma Virus (HPV) vaccine.
We, the undersigned, public health organisations, health networks, medical professionals and women’s groups, write to express our concern with regard to the introduction of the human papilloma virus (HPV) vaccine, Gardasil, to young girls in the country.
On July 9, 2009 under the demonstration project being implemented by the union ministry of health and family welfare in association with the Indian Council of Medical Research (ICMR), PATH International and the state government, the Andhra Pradesh minister for health and family welfare launched a pilot programme for vaccination against cervical cancer. The three doses of the HPV vaccine are to be administered to 16,000 girls between 10 and 14 years in the mandals of Bhadrachalam, Kothagudem and Thirumalayapalem in Khammam district in Andhra Pradesh (1). The vaccine will be administered in three doses at the interval of 0, 2 and 6 months.
Similarly, on August 13, 2009, the Gujarat government launched a two-year ‘Demonstration Project for Cancer of the Cervix Vaccine’ in three blocks of Vadodara District - Dabhoi, Kawant and Shinor - to immunise 16,000 girls between 10 and 14 years with three doses of Gardasil. The Gujarat state minister for health and family welfare claimed that this demonstration project would help the Centre to examine the possibility of introducing the vaccination project across the country (2).
We are alarmed by this decision by state and union governments and we oppose the introduction of the vaccine on the following grounds:
Efficacy of the vaccine
* Information about the efficacy of Gardasil remains uncertain. The current HPV vaccine prevents infections, resulting from just two of the HPV subtypes (16 and 18) that may cause cervical cancer, and also HPV subtypes 6 and 11 that can lead to genital warts. The subtypes 16 and 18 account for 70% of the cases of invasive cervical cancer globally (3). But there are over 100 HPV subtypes and one of the main concerns is that if the vaccine was to work and indeed “block” subtypes 16 and 18 then the other carcinogenic subtypes may become dominant.
* There is lack of conclusive data regarding the length of immunologic protection that the vaccine confers against HPV subtypes 16 and 18 (4). Studies so far have followed up with the vaccinated “subjects” for five years and have shown that it offers protection only for five years. Thus it is not clear whether protection lasts longer than this time period. Since the long-term efficacy of and protection by the vaccine is unknown we cannot claim that even 60-70% protection will be achieved. Moreover, since the highest incidence of cancer of the cervix in India is in women above 35 years of age, it is not clear whether a three-dose schedule will provide long lasting immunity or if boosters will be required.
* If booster doses are needed, and it is not known how frequently, what will be the impact of the booster doses on the safety of the vaccine? Moreover, booster doses would certainly increase the cost of vaccination per woman as many times as the booster would be given.
* HPV vaccination is not a substitute for cervical cancer screening. All women, including those who are vaccinated, should continue to have regular Pap test screening and also HPV test as the preventive effect of the vaccine on cervical cancer has not yet been demonstrated.
* HPV infection rarely leads to progression to cancer. Only a minority of infections persist for several years, and only about 10 per cent of low-grade lesions progress to a higher grade. About five per cent of high-grade lesions progress to invasive cancer (5).
1. The Federal Vaccine Adverse Event Reporting System (VAERS) in the United States has logged a total of 12,424 adverse events following HPV vaccination, according to the US Centers for Disease Control and Prevention. Between June 2006 through December 2008, more than 23 million doses were administered in the US alone. Of these, 772 were reports of serious events (6.2% of the reports) including 32 deaths and the remaining 11652 (93.2% were classified as non-serious. The most common events reported were, syncope, local reactions at the site of immunisation (pain and redness), dizziness, nausea and headache(6). Venous thromboembolic events, autoimmune disorders, Guillian Barre Syndrome, motor neuron disease, anaphylaxis, transverse myelitis, pancreatitis and death were amongst the serious adverse events reported. Amongst reports of autoimmune disorders to the VAERS system, 88% were associated with the HPV vaccine alone (7).
2. In Australia, the rate of anaphylaxis shock after Gardasil injection has been reported as 2.6 per 100,000 doses (8).
3. The official Gardasil website itself clearly mentions, “GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it’s important to continue routine cervical cancer screenings. GARDASIL does not treat cervical cancer or genital warts.” The side effects listed include, pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity (9).
4. The Indian Academy of Pediatrics Committee on Immunization (IAPCOI) in its recommendations mentions that the vaccine is contraindicated in those with a history of previous hypersensitivity to any vaccine and should be avoided during pregnancy (10). Moreover, there have been no adequate and well-controlled studies in pregnant women, and animal reproduction studies are not always predictive of human response (7).
Moreover, while this data is mostly sourced from US-based research and trials conducted in other countries, the adverse reactions in the Indian context are unknown. Thus, the approval of a vaccine that claims to prevent a sexually acquired infection that sometimes causes cancer of cervix, and that too only if vaccination is completed before exposure, is highly questionable.
* The current cost of the vaccine is Rs 3,000 per dose (approximately USD 60). So for every 10-year-old girl, three shots initially, and eight shots (assuming the need for a booster shot every five years) over the next 40 years (until she becomes 50). This would amount to Rs 33,000 by present estimates. Can the ministry afford an injection that costs Rs 9,000 for every woman in a country where we cannot give DPT (costing Rs 3) to 50 % of children of the country?
* In a recent study from India, published in the New England Journal of Medicine (NEJM), 31,488 women (30 to 59 years old), were followed up over eight years with no intervention (in the control group). 64 died of cervical cancer. The absolute risk of cervical cancer was 2.5/10,000/year. If we optimistically assume that every case of cervical cancer will be prevented by the vaccine, the absolute risk reduction is 0.00025 and the number of women needed to be vaccinated to prevent one death is 4,000. So the cost per life saved is Rs 75 million (11).
* A cost effectiveness study published in the NEJM in 2008 concluded that if the vaccine provided protection against HPV for only 10 years, then vaccinating preadolescent girls would only provide a “2% marginal improvement in the reduction in the risk of cervical cancer as compared with screening alone.” Moreover, it would cost USD 144,100 for each healthy year of life saved, instead of the USD 43,600 estimated for a vaccine providing life-long protection. Most researchers believe that even in the US, interventions costing more than USD 50,000 per quality-adjusted year of life (QALY) saved, are not cost-effective, while others use a higher ceiling of USD 100,000 (12).
* Looking at our public health system, no government in India can afford this expense. The average per capita annual income in India in 2009 is Rs 38,000, while the current per capita annual public health expenditure in India is about USD 10.
* Given this totally unfavorable cost-efficacy in the Indian context, we see no chance that this vaccine can be included in the Indian national immunization programme. Hence conducting such a demonstration project in India would mean using Indian people as mere guinea pigs.
* Merck Sharp & Dohme (MSD) India Pharmaceuticals Private Limited, which is the Indian subsidiary of Merck & Co. Inc., the manufacturers of Gardasil, has also recently started a cervical cancer prevention programme that informs Indian women to help protect them against cervical cancer and related HPV infections. The programme’s tagline, “What will I do to save my daughter from cervical cancer? - Everything that I can!” (13), is uncannily similar to Gardasil’s tag line - “We chose to help protect ourselves against cervical cancer and other HPV infections: Now the choice is yours.”(9) Similarly, PATH, that supported the formative research for the HPV vaccine Gardasil in India, highlights the demand for the vaccine through quotes like “Our granddaughters’ generation should be a generation without cancer.”(14) In this way a false signal is sent out that claims that the vaccine can prevent cancer although Gardasil prevents cancer of cervix associated with just two types of HPV.
* These advertisements induce fear with regard to HPV and cervical cancer and thus create an inaccurate impression of a “public health emergency”.
* A 15-second commercial on Indian television urges parents to get their young girls inoculated with the vaccine Gardasil to protect against cervical cancer, Advertising prescription drugs on television is unethical enough, but using fear and inaccurate claims to sell them is worse (15).
We urge that
1. The Government should review the decision to conduct a demonstration project of the HPV vaccine in the mass immunisation programmes in the absence of sufficient long-term evidence of its effectiveness and complete and unbiased information, and without any prior public debate. The huge cost incurred in this mass immunisation even if the current price of the vaccine is reduced substantially should be seriously considered.
2. The state initiates comprehensive access to reproductive and sexual health programmes / services for adolescents, women and men.
* The focus should be on increasing access to preventive healthcare services such as Pap screenings, visual screening of the cervix with acetic acid (VIA) and Visual Inspection of cervix with Lugol’s Iodine (VILI).
* Screening programmes should be augmented with newer technologies such as the use of liquid-based Pap testing in women, who have abnormal Pap test results.
* Provide population-based outreach Pap screening services for cancer of cervix, particularly for women from the tribal and rural areas.
* Undertake special measures towards promoting awareness among women and communities so that they come forward without any inhibitions to undergo such screening tests.
* Instead of an expensive vaccination strategy, monitoring measures should be made available to detect cervical cancer at a very early stage. Treatment of all women with the diagnosis of cervical cancer in situ is likely to cost the public healthcare system much less than buying the vaccine.
* Public health services be made available to all, with special emphasis on women’s health, by filling in the vacancies of gynaeocologists and para-medical workers and by providing basic screening facilities.
3. As mentioned earlier the current vaccines target only two oncogenic types: HPV-16 and HPV-18. Secondly, the relationship between infection at a young age and the development of cancer 20-40 years later is not known. So how should a parent, physician, politician, or anyone else decide whether it is a good thing to give young girls the vaccine that partly prevents infection caused by a sexually transmitted disease that in a few cases will cause cancer 20-40 years from now? (16)
4. It is learnt that the union health ministry has signed a memorandum of understanding (MoU) with the US company Merck, covering the entire gamut of the trial and the launch in the country. As per the MoU, the pre-introductory trial will be carried out at several centres in the country, including the Institute of Cytology and Preventive Oncology (ICPO) (www.icpo.org.in) for a duration of six months. What is the status of these trials and if they have been completed, what are the results / findings?
5. Financial support from industry or from an international organisation should not be the criterion to introduce any vaccine in a pilot phase or in a universal immunisation programme.
6. The role of PATH is not very clear. It appears that PATH is trying to find ways of influencing policy makers through its formative research.
1. All trials and studies to be immediately brought to a halt till, in an open forum, questions relating to the safety, efficacy and cost effectiveness of the planned intervention can be justified.
2. To place before the public:
* All the documents pertaining to the agreement with vaccine manufacturers and all other bodies regarding the government’s plan to introduce the HPV vaccine. The list of all trials planned, proposed, approved and completed, the agencies involved, the donors involved and the proposed locations and all the results of the pilot phase trials as well as clinical trials.
* The status of approval accorded to the vaccine and the data which has been submitted by the company (vaccine manufacturer) for the purpose.
* The estimated total cost, as per the government’s assessment, of purchase of the vaccine and its administration.
3. A vaccine policy to be formulated based on public health needs.
4. Open up the issue for public debate with the opinion of health groups, women’s groups and other civil society members to be actively sought.
We urge you to consider these demands very seriously and act upon this matter in the larger interest of the health and well-being of women and adolescent girls of this country. We ask you to provide the information and documents that we have requested within a month of the receipt of this letter.
Dr Gopal Dabade, All India Drug Action Network (AIDAN); Medico Friend Circle (MFC); Jan Swasthya Abhiyan (JSA); All India People Science Network (AIPSN); Centre of Social Medicine and Community Health, Jawaharlal Nehru University (JNU), Delhi; Sama Resource Group for Women and Health, Delhi; Dr Y Madhavi, National Institue of Science Technology and Development Studies (NISTADS), Delhi; Jagori, Delhi; Dr Imrana Qadeer, Delhi; Dr N Raghuram, Guru Gobind Indraprastha University, Delhi; All India Democratic Women’s Association(AIDWA), Delhi; Action India, Delhi; Human Rights Law Network (HRLN), Delhi; Delhi Forum, Delhi; Centre for Women’s Development Studies (CWDS), Delhi; The Other Media, Delhi; TARSHI, Delhi; Partners in Law and Development (PLD), Delhi; MATRIKA, Delhi; Indira Chakravarthy, Public Health Researcher, Delhi; Ranjan De, film maker, Delhi; KRITI, Delhi; Dr Veena Shatrugna, Hyderabad, Andhra Pradesh; Dr Sagari Ramdas, ANTHRA, Andhra Pradesh; Andhra Pradesh Adivasi Aikya Vedika, Andhra Pradesh;Dr Rukmini Rao, President, Gramya Resource Centre for Women, Hyderabad, Andhra Pradesh; Yakshi, Hyderabad, Andhra Pradesh; Locost, Vadodara, Gujarat; SAHAJ, Vadodara, Gujarat; Utthan, Ahmedabad, Gujarat; Sahiyar, Baroda, Gujarat; Dr Hanif Lakdawala, Ahmedabad, Gujarat; Dr Hemant Shah, Deputy Director, Bhansali Trust, Radhanpur, Gujarat; Mahila Sarvangeen Utkarsha Mandal (MASUM) Pune, Maharashtra; Dr Anant Phadke, Sathi-Cehat, AIDAN, Pune, Maharashtra; SATHI-CEHAT, Pune, Maharashtra; CEHAT, Mumbai, Maharashtra; LABIA, Mumbai, Maharashtra; Forum Against Oppression of Women, Mumbai, Maharashtra; Ravi Duggal, Mumbai, Maharashtra; Dr Amar Jesani, Independent Consultant on Bioethics and Public Health, Mumbai, Maharashtra; Dr Lakshmi Lingam, Professor, Women’s Studies, Mumbai, Maharashtra; Dr Dhruv Mankad, Hon. Director, Vachan, Nasik, Maharashtra; Amitava Guha, FMRAI, Kolkata, West Bengal; Dr Narendra Gupta, Chittorgarh, Rajasthan; Drug Action Forum, Karnataka; Community Health Cell (CHC), Bangalore, Karnataka; Dr Daisy Dharmaraj, TEST Foundation, Chennai, Tamilnadu; Dr Subhashri, Chennai, Tamilnadu; North East Network, Assam; Dr Ajay Khare, Madhya Pradesh Vigyan Sabha, Bhopal, Madhya Pradesh; Jagannath Chatterjee, Bhubaneswar, Orissa.
This memorandum was compiled by Anjali and Sarojini, Sama, with inputs from various individuals and organisations. It was submitted to the Union Minister for Health and Family Welfare, Government of India in October 2009. It is also available on the website www.holyhormones.com
C/o Sama, B-45, 2nd Floor, Shivalik Main, Malviya Nagar, New Delhi 110 017 INDIA email email@example.com
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Source of whole article: http://www.issuesinmedicalethics.org/181de38.html