Is Gardasil, the cervical cancer vaccine, to blame for the death of Adriana Kolbecher, a teenager from the French Hautes-Pyrénées region who died on the 20th of October 2010? Her parents think so even if so far, there is no proof.
The number of lawsuits against Gardasil, the cervical cancer vaccine administered to many young French girls every year, is on the rise. An increasing number of doctors are also questioning its effectiveness on a daily basis and some of them are even suggesting that it could be dangerous.
Did Gardasil cause 17-year-old Adriana Kolbecher’s death on the 20th of August 2010 at Rangueil Hospital in Toulouse? The diagnosis by doctors in the neurology department was “autoimmune encephalitis” but they were unable to explain why this teenager’s brain became so rapidly and violently inflamed.
Adriana’s parents are convinced that it was indeed Gardasil which “killed” their daughter.
One of the doctors wrote in his medical notes: “Possible cause: Gardasil” but a Rangueil neurologist advised them to be careful: “Gardasil being the cause is a hypothesis but we have no evidence to substantiate this” he explained.
Adriana’s parents, Mr. and Mrs. Kolbecher, have nonetheless decided to take the manufacturer to court.
It was only after reading an article in the press reporting the “ordeal” of another teenage girl that they started to suspect Gardasil.
Sudden Aggravation
“Later, while surfing the net, it was confirmed to us by a large number of overwhelming testimonies”, explained her parents. “It was shocking to read because some of the adverse effects described were very similar to what Adriana had experienced after her vaccination on the 24th of October 2008.”
Like most of these teens, sometime after the vaccination, Adriana started complaining of “headaches, tummy aches… nothing really out of the ordinary for a teenager but these complaints became gradually more pronounced after the second jab (19th December 2008)”, continued the parents: “anxiety, hot flushes, tingling in her legs, muscle pains, difficulty walking… until she had a major loss of consciousness on the 18th of April 2009. After the third injection (24th April 2009), these adverse effects became intermittent and others appeared: total exhaustion, fainting, moodiness, loss of appetite… Although Adriana had always played lots of sports, she no longer had the energy to do anything and couldn’t even go upstairs to bed on her own.” One slightly distraught GP even advised them to consult…. a shrink.
At the end of July 2010, Adriana’s condition suddenly deteriorated: loss of weight, confusion, memory blanks, behavior problems…. “In early August 2010, she was hospitalized in three different hospitals and was finally put into an artificial coma, due to irreversible fits. She never woke up from the coma”, report her parents.
Around 50 French youngsters claim to be Gardasil victims and their families have already filed lawsuits in the French courts.
Complaint of “Manslaughter”
Adriana Kolbecher’s parents decided to take her case to the courts. As such, they will be filing a lawsuit for “manslaughter” this week. This will be the first such case, since most of the others have been filed as “accidental damage to physical integrity and deteriorated deception”. Fortunately, none of the other plaintiffs died.
André Dahlab, Medical Director of the Sanofi Pasteur MSD group who manufacture Gardasil replies that “the vaccine’s risk-benefit ratio has never been questioned but this is a difficult time for vaccines.”
June 19 2014, Logroño, Spain: Attorney Don Manuel Sáez Ochoa filed a criminal complaint against Merck-Sanofi Pasteur Laboratories, Spanish National Health authorities, and the regional health authorities of the La Rioja province on behalf of Zuriñe Jiménez Guereño and her mother Doña Maria del Carmen Jiménez Guereño for injuries and disabilities suffered by Zuriñe after the administration of Gardasil.
The complaint states that Merck Laboratories failed to use an inert placebo during clinical trials, thereby manipulating data and marketing Gardasil under false pretences. Despite complaints of several young women with similar new medical conditions after Gardasil injections, the Spanish health authorities ignored calls for a moratorium on the use of Gardasil until the safety issues were resolved.
Both regional and national health authorities made no attempt to verify the accuracy of the safety data Merck submitted to gain approval for the widespread administration of Gardasil as a cancer preventative; nor did they make any attempt to inform the public that an already proven safe and effective means of controlling cervical cancer was already in existence.
The complaint goes on to say both national and local health authorities had adequate knowledge regarding the potential harmful effects of Gardasil and chose to recommend administration of the HPV vaccine anyway. The complaint alleges this showed an absolute disregard for the health and well-being of young Spanish girls.
According to the complaint, the attitude of the Merck pharmaceutical company and Spanish health authorities (both national and regional) before, during and after the administration of Gardasil shows they care nothing about the risk to which medical consumers expose themselves whenever Gardasil is used.
The complaint states, prior to administration, no one was concerned about possible adverse reactions to the vaccine. When adverse reactions did occur, those who experienced them were treated with contempt leaving them in a state of helplessness. There was allegedly not one single official inquiry about the girls’ post-Gardasil conditions even though they were healthy prior to being injected with Gardasil.
An outcry from the public calling for a moratorium on the use of Gardasil until safety issues were resolved was ignored by Spanish health authorities. Injections of Gardasil continued despite the damage left behind.
According to Attorney Don Manuel Sáez Ochoa,
(claiming) a possible exemption arguing that they did not know at the time of processing, the dangers of the vaccine (Gardasil) is laughable……Frankly this attitude seems clearly malicious and constitutes the offense of injury as per Artile 149.1 of the Criminal Code that states: To cause another, by any means or process, the loss or worthlessness of an organ or principal member, or a sense, impotence, sterility, severe deformity, or severe somatic or mental illness, shall be punished with imprisonment of six to twelve years.
Charges contained in the official criminal complaint
Merck-Sanofi Pasteur, Spain’s National and Regional (La Rioja) health authorities are charged with the following:
fraudulent marketing and/or administration of an inadequately tested vaccine;
failure to inform the public about the potential risks of using Gardasil;
clear infringement of the right to informed consent;
ignoring new medical conditions in those who used Gardasil despite the similarity of their symptoms and the relatively short period of time between vaccine administration and the onset of symptoms;
ignoring established and new scientific evidence illustrating the potential harmful effects of Gardasil ingredients and manufacturing methods;
callous disregard for those suffering new medical conditions post-Gardasil;
failure to inform the public that HPV infections are simply one of the risk factors involved in the development of cervical cancer;
failure to inform the public that 90% of all HPV infections clear on their own without medical intervention;
failure to inform the publlic about alternative methods of controlling cervical cancer; and
criminal liability for the injuries resulting from the administration of Gardasil
Even if one assumes that Merck-Sanofi Pasteur and all of the government health officials were not aware of the potential risks and lack of proven benefit of Gardasil, there has been plenty of scientific and medical evidence provided since 2007 when the vaccine was approved for use in Spain.
Given their expertise, all of these people were aware of the fact that there are several methods to control cervical cancer that have already been proven safe and effective.
Zuriñe was a healthy, athletic and academically gifted girl until she received the recommended three doses of Gardasil via an immunization program at her school when she was 13 years old. Three weeks later, she was admitted to the emergency room of her local hospital suffering from a multitude of symptoms including dizziness, fatigue and convulsions.
After receiving no answers from her doctors, the conversations began to include hints of conversion disorder. Her parents decided to take her to a private specialist.
According to this specialist, Dr. Mark Mazzuca:
Zuriñe suffers severe cell disease, oxidative stress linked to a demineralization of her body. To put it graphically, she is an 18 year old girl locked in a cell body of a person over sixty years old. Zuriñe also suffers from hard infield Ortostátiaco Postural Syndrome polyneuropathy revealing a central character. It also presents as liver and bladder inflammation.
Five years after her last Gardasil shot, Zuriñe’s life bears little resemblance to anything she once considered normal. In and out of hospitals dealing with ‘mysterious’ new medical conditions every day. No one knows how much of her normal life she will be able to regain.
Thousands of young women around the world are finding themselves in the same position as Zuriñe. They have gone from being happy, active, and healthy to facing a multitude of autoimmune problems and neurological disorders. For them, the ‘possible’ adverse effects of Gardasil have become an all too harsh and brutal reality.
It is time for those responsible to be held accountable for their actions. Criminal prosecution is quite possibly the only way to accomplish that goal.
Perhaps six to twelve years in prison would remind those responsible what it means to conduct yourself in an ethical manner. Perhaps they would remember that their first duty is to maintain the public health, not destroy it.
On July 30, the Judge decided to open criminal proceedings and investigation of the facts. The first criminal case in Spain regarding Gardasil injuries and potential criminal liability begins.
I am the fortunate one.I am the Mother of a brilliant, intelligent, empathetic, and wise beyond her year’s young woman.We live in Sydney, Australia, with her Dad, little brother, and little sister.I will call her G.S.As in Gardasil Survivor.
G.S.Golden girl.My first born.Ridiculously talented.Ridiculously wise.Ridiculously beautiful inside and out.Like all our children, ridiculously loved.She remains so.However now, she is ridiculously ill. G.S. is the type of person that everyone loves.Pre-Gardasil, everyone celebrated her accomplishments with us.Athletics champ.Singing voice to die for.The courage to sing a solo on the stage of the Sydney Opera House in front of a 600 strong choir.She was just ten years old. School Captain in Primary School.Primary School Dux.The stuff we are lead to believe dream kids are made of.More than I can even begin with here.You get the picture. When G.S. was in her first year of High School, I gave my consent for her to receive the Gardasil vaccine.I totally believed that I was protecting her.I did not, however, research the side effects of this particular vaccine prior to giving my consent.Put bluntly, I bought the hype. Hind sight screams at me daily. We now live with the consequences of that decision.Worst of all, my daughter has been forced to endure what she now has to go through because of that decision.The effects of toxicity.The myelin depletion in her brain, made evident in the results of an MRI during her first hospital admission.Cue the auto-immune disease diagnosis.And then the P.A.N.D.A.S. one.Welcome chronic depression into the mix.Suicidal ideation.Low blood pressure.Muscle and joint pain.EEGs to capture seizures.Inability to eat and drink, or care to do anything.Having to be constantly motivated to move, speak or participate in her own life.Sleeping on a mattress outside her bedroom door at night to protect her from herself.Hiding and locking up all knives and sharps for the very real fear of suicide.Being too unwell to continue High School or complete H.S.C.Feeling less than adequate because of it.A revolving door of hospital admissions.DenialFear, pain, anguish, guilt. There is so much more.There continues to be so much more.There is no magic bullet.There is only on-going management, not cure.We have been forced to accept a new brand of normalMuch of it is simply not easy.We are, however, entirely committed to making our girl’s quality of life all that it should, and could be. We are four years post Gardasil now.We continue with the battle.Our G.S continues with her battles.We have no choice. There are no options.Every day.Battles.There are so many other issues and concerns that I could outline here, but these are some that I hope you might consider.Do inform yourself about the possible side effects in relation to the Gardasil vaccine.Check out the product insert and look at the ingredients in the vaccine.Weigh up the side effects very carefully.Assess the general health of your child, and consider the impact of this vaccine in terms of your own child’s genetic predisposition which may or may not result in the manifestation of particular illnesses, syndromes or conditions.Clearly understand that the Gardasil vaccine is affording it’s marketers a massive amount of monetary profit.With no proven efficacy. The thing is, most parents that have not given consent for the administration of this vaccine to their children are not crazy hippie, weirdoes, or ill-informed ant-vaxxers.Be prepared for mainstream media and most doctors to characterize you that way should you refuse this vaccine.Sadly, governments, and profit driven pharmaceutical companies would like to paint us in that way.Because it is to their benefit.It is also much easier, safer and convenient for us and them for everyone to go with the flow.It is simply not the case.It is simply untrue.Do not be intimidated.The co-incidence argument is also tiresome and unfounded.What an incredibly hard lesson we have learned. If only I could turn back time.Kate and G.S., no words can portray the feelings in my heart for this enduring trial. I know that our Heavenly Father loves you, and aches for your pains as well. He will guide you, and comfort you. Our prayers are with you. So often I feel that music helps us to heal, and be even stronger. I hope this song can ease the sadness, and bring peace to your soul. Your friend, jen 🙂
Haleigh’s story starts out like many others. She was always involved in some kind of sports: gymnastics, dance, cross country, track/field, flag football, basketball, softball, plus just doing outdoor activities bike riding, long boarding, hanging out with friends etc… The family was always involved and enjoyed watching her at any of her events. She was very happy, though she was always shy and quiet in her classes (her teachers always told us how much they loved her and how respectful she is but wished she would talk more).
The only time she ever went to the doctor was to get immunizations and physicals to play sports and couple of injury visits. Haleigh received her first injection of Gardasil on the 26th of June 2008 and the second on the 24th of September 2009.
She was in 7th grade with her 13th birthday coming up at the end of Jan 2010. We planned a trip to the “haunted” Stanley Hotel in Estes. I remember earlier in January she was sick and vomiting a couple different times. When she recovered I thought – good, she will be healthy for the trip to the hotel.
While at the ‘haunted’ hotel, she slipped and fell on a small grass hill and broke her wrist. We all joked about it saying that a ghost pushed her.
During the first weeks of Feb 2010, she started to have stabbing pains in her right side (gallbladder) and more nausea. At first, the doctors thought maybe the pain was from the fall at hotel and prescribed physical therapy and some pain meds.
That didn’t work, so they said she was either having cramps or she was constipated. She was prescribed a soft laxative. Haleigh knew this was not her problem.
We returned to the office several times, pleading with them to not prescribe any more medications that would simply mask the problem. We knew something was seriously wrong.
They could see from her medical records that we did not visit them previously for anything other than routine visits. Haleigh explained repeatedly that she was experiencing stabbing pains and nausea all the time.
In April we went in and the doctor actually asked how she was during spring break insinuating that she might have been faking symptoms to avoid school. I said, “As the matter of fact, it is her spring break now and she is miserable.”
I could not believe they just kept trying to medicate her for a UTI (urinary tract infection), cramps and constipation.
After two and half months of watching her suffer rolled in ball crying, I searched for additional help and found a doctor who ordered a hydascan (special nuclear die test). This test revealed that her gallbladder was functioning at less than 10% of normal capacity.
Her gallbladder was removed two days before Easter 2010. The surgeon said he had no idea why it was not functioning because it looked to be a healthy gallbladder with no sludge or any defects.
No, she did not fit the profile for a gallbladder issue but we were happy to have the answer and move on. She would feel better now. The stabbing pain was gone. She was affected by foods now that she didn’t have a gallbladder. We had to spend some time getting used to know what foods she could and could not eat.
In Sept 2010, she started having issues again – back to hospitals and doctor visits. This time we thought it was due to her gallbladder but, the stabbing pain had come back in the lower right side this time.
The doctors said this was because she might have ovarian cysts and sent her to the women’s clinic during the first week of November. The clinic put her on birth control pills and Vicodin.
By the end of November, Haleigh was in so much pain her family doctor sent us back to the women’s clinic where the doctor said this has nothing to do with cysts. She felt it was appendicitis and admitted her to the hospital.
The hospital kept her there for two nights and many tests with no explanations forthcoming. They said she was a ‘mystery’.
The family doctor thought stress was causing her stomach to produce too much acid and said she should take some antacids.
After watching her suffer again with stabbing pain, I started searching for answers with other doctors. We went to Children’s Hospital and saw a gastroenterologist. The week before Christmas she was back in surgery getting her appendix removed and small cyst that had ruptured on her right ovary.
Again the surgeon stated that the appendix looked healthy. So now that she has no gallbladder or appendix and she’s on birth control pills to help with cysts. She should be on the up and up now.
Despite all of Haleigh’s mysterious new symptoms, no one considered the possibility of any connection to the Gardasil vaccine. She received her third and final injection on the 9th of March 2011.
Throughout the entire ordeal, her teachers were very understanding and helpful. They knew Haleigh and felt so bad knowing she was not well. She desperately wanted to get back into sports. Running was painful for her now and tiring. We thought this to be from her surgeries.
Haleigh started gymnastics again just before 9th grade started and injured the lisfranc ligament in her foot. She was unable to start the softball season in high school because she was in a boot.
The summer before 10th grade she had high school softball practice and began the season. Right at the start of school she had a first aid class outside and was stung by a bee in the foot. Haleigh has been stung before and had no allergic reaction, but this time her foot became so swollen she could not get her cleats on for her softball games for a couple of weeks.
Once she was back to practice she was hit in the face with ball while warming up with a teammate. She was unable to play for most of the season because of the concussion, but was back playing by the end of season.
After Haleigh’s 16th birthday in January, she experienced pounding headaches and spells of vomiting every day up to 6 times per day for almost 3 months. We now had a different family doctor. He ordered many tests to be done all of which came back normal. Again with the “mystery” illness. He thought she should try Prilosec. This did not help, so he sent us back to Children’s Hospital to the gastroenterologist. They did an endoscopy and found that she had bile in her stomach and that her stomach lining was irritated – but could not see why.
She was also having constant headaches that did not go along with GI problems, so we were referred back to the concussion clinic. They stated it was too far past the time of the accident for her conditions to be post-concussion symptoms.
Throughout this time we did all that was asked of us, went wherever they sent us, and submitted to every test they recommended. With no questions asked!
Her doctor would just say, “She’s a mystery, maybe we are just chasing our tails with no answers to be found.”
Now it’s 2014, she has missed lots of school. Her teachers could tell she wasn’t well and were very helpful with her class work.
January and February of this year brought on another bout of nonstop vomiting and headaches. Back to ER more blood tests and scans – all coming back normal.
Now, doctors are mentioning more and more that she must be under stress which is causing all of her ‘mysterious’ new medical conditions. This of course does not make us happy. We know that depression is not the cause of our daughter’s new health issues. Having doctors claim it is depression is discouraging and depressing all by itself.
Around the middle of Feb 2014, she began to have some type of small seizures. I came home from work and found her on the floor, very upset and scared. She said her heart was racing, then her legs went stiff and she fell to floor shaking.
I called the doctor and they sent us to the emergency room. The ER doctor did CAT scan and blood tests and found everything normal. The doctor stated Haleigh obviously had depression which was causing this to all happen.
At this visit we spoke with the hospital counselor. That is when the light came on for us regarding Gardasil. I discovered that she had her 2nd HPV shot just 4 months before the Jan 2010 stomach issues.
We followed up with the family doctor and asked if it could be the HPV Vaccine. His answer was, “I’m looking on the VAERS reports right here and I don’t see anything that shows any side effects reported.”
He said he felt it was “conversion disorder” and wrote it down for me. He said he wasn’t saying she was crazy or doing it on purpose but that her brain was causing all of this to happen.
I asked him right then, “So, what you are saying is that her brain caused her gallbladder to stop functioning?”
His answer was, “That may have been the root cause for all of this. She should go to a psychiatrist so that she has someone that would listen since she’s been through so many mystery illnesses with no answers.”
He also said that he didn’t want to put her through any more test with no answers; that we were just going in circles.
I asked if there was some test that could be done to at least rule out the possibility that her symptoms might be related to Gardasil.
He replied, “We haven’t got one yet.”
In April 2014, Haleigh got very sick again. This time her throat and face started to swell, so we were told to take her to ER where she tested positive for mono. She was vomiting every day for two weeks, she also had headache and dizziness.
We now have more of an understanding of what is going on with our Haleigh. Just knowing helps us get through this nightmare ride. We hope to get answers by reaching out.
Here is a list of some of her many symptoms throughout the past 4 years:
Nausea
Vomiting
Headache/stabbing headache
stabbing abdominal pain
Dizziness
chest pain
fatigue
joint pain
shortness of breath
Racing heart
back pain
neck pain
skin rash
seizure symptoms
Black outs
foot pain
bloating/swelling
Here is a partial list of the medications she was given the last 4 years:
Amitriptyline
Cephalexin
flexeril
Keflex
Meloxicam
Promethazine
Compazine
Naproxen
Prilosec dr
Ranitidine
Zofran
Cyproheptadine
Prednisone
meclizine
amoxicillin
tramadol
imitrex
trokendi xr
Carafate
Sprintec
Oxycodone
ondansetron
Some of these medications were prescribed many times. Had any of them worked at all for her, we would have stop searching for answers. At this point, reaching out to others who are in similar circumstances is our only hope of obtaining any answers. We have no other option.
I hate the fact that I was made to question my daughter. I hate the fact that the medical community tried to convince me this was simply teen hormones and/or stress.
I cannot begin to describe how difficult it has been to watch her suffer so badly and receive nothing but doubt and excuses from the professional medical community. I can only imagine how difficult it has been for Haleigh.
Nevertheless, Haleigh has stayed strong through the whole ordeal. She has had the support of family, close friends and teachers. We will all continue to support her and fight to find answers for her.
Haleigh and Tamara, I am so sorry to hear of your plight. What a trial! Your fortitude, and exactness, through this time, is truly impressive. It is so nice to hear of the wonderful support from your friends, family and teachers.
Thankfully, you have heard about SaneVax.org. No need to lose any time now. They will have excellent guidance, and please look through the Featured Doctors section of my blog. There are individuals healing the world over, and probably best to work with a doctor that is familiar, and successful in caring for like conditions.
I hope you like James Taylor and The Dixie Chics. I like to share a little music to help you take your mind off things for awhile.
Please know, you are in good hands now, and look ahead to the future. Your friend, jen 🙂
It is now May 2014. It was May 2009 when Shania had the first of the two Gardasil shots that ruined her swimming career and her life in the ensuing years. (You can read about that in the links above.)
In 2014, the only obvious legacy from the Gardasil damage is a poor immune system. But we are working on that. Other changes…
This year she has been one of the first to catch the seasonal colds but unlike the past years, the colds have not all gone straight to her chest and given her bronchitis; neither have they hung around for weeks or months. She is bouncing back more quickly, which is a hugely positive sign. And she no longer needs her Asthma puffer either.
It has been said that the effects of the Gardasil vaccine may only last 5 years and that 5 year limitation is every Gardasil victim’s lifeline. Here’s why…
It started last year – obvious signs that something was happening healing-wise. Shania was in 2 major shows one after the other for starters. She had the lead of Mabel in Gilbert and Sullivan’s ‘Pirates of Penzance’ the first part of the year, and then she went straight into the ensemble of ‘The Phantom of the Opera’ for the second part of the year (her idea of relaxation!).
THIS year, 2014, is her final year (year 12) at Senior High School level in Australia. (Next year is University.) This year, the DAY BEFORE THE COMPETITION, the Director of Sports at her college begged and pleaded with her to consider to swim with their relay team at the inter-schools competition, even if she didn’t want to do the individual races, just help them out with the relay events. Apparently one of the swimmers had to drop out at the last minute.
Of course, she said no. She’s had to say no every year since 2009. She hasn’t been in the pool racing since she collapsed in 2009. She hasn’t trained since she tried to go back in 2010 and realized she couldn’t. The mind was willing but the body couldn’t. And now, she’d been out of the pool 4-5 years and this guy wanted her to race?
But he persisted. His argument was that even in her poor condition having not swum or trained for so many years, she was still bound to be better than somebody with none of her background.
Cutting a long story short he wore her down. The College swim team had been training for months and had even gone on a swimming “camp”! Shania’s only “training” for this event was a 40 minute warm up the night before the competition at the local pool. I sat on the sidelines, a very worried mum because the last time she’d been in the pool racing was early 2009.
Next day at the competition at Challenge Stadium she swam in the relay team for the B Division of the College. They put her in first place in this relay team – the first swimmer off the block. To her and everyone else’s surprise, she gave the team a nice lead and a head start over the schools in the other lanes.
The teachers were so impressed they figured they’d put her in their A Division relay team too. They placed her second in the team, meaning she’d be the second swimmer off the blocks. A new experience for her – in her past swimming life she had always been either the first swimmer (to give the team a good lead) or the last swimmer (to catch up if the team wasn’t in first place). But she didn’t care. She was happy to be back in the pool doing what she loved.
So, the A Division relay starts… The first swimmer went in and at the end of the first 50m leg, their team was in 6th place… not a great start… better than 7th or 8th, of course, but hardly inspiring for Shania who had to follow this as the second swimmer.
She dove in and started swimming. She powered up the pool from 6th place, overtaking all the other lanes and when she touched the other end, she’d put her team in first place with a good lead. The Announcer said “Who on earth is THAT!”
The school sport director was celebrating. He knew who it was and he’d seen it all before… albeit many years before!
It also heralded the moment when I finally believed that we were no longer in that tunnel looking at the light at the end… we had passed through it! Shania could not have done what she had if Gardasil was still affecting her. And she couldn’t keep up this timetable either…
This year she is in her final Year 12 of school. She is studying 5 TEE subjects. Her homework schedule has to be seen to be believed! Now she knows why some people only do 3 or 4 TEE subjects… she chose 5. One of them requires filming on weekends and in her precious holiday breaks – Media…
She is also the College Cultural Prefect with additional responsibilities including having to arrange the Year 12 Ball. She is also the lead, Belle, in the College musical production of Beauty and the Beast. She rehearses 2-3 times a week and this includes some Sundays, like tomorrow – from 10 am to 4 pm, and then she comes home and has to knuckle down and do homework and study.
Plus she does a LOT of singing – she has to learn about 7 songs for her exams, plus she recently sang the National Anthem at the Peel region ANZAC Day Memorial Service, and has to rehearse 7 other songs because she is singing at a private soiree later this month. She let piano go but only because she simply couldn’t fit it in!
Every Saturday morning, we drive up into the city a good hour’s drive away for her classical lessons, then zoom back home and then she goes to work from 1 to 5 at a news agency. Sometimes she goes to a babysitting assignment after that. She also goes to the gym once or twice a week. She is burning the candle at both ends trying to study for Year 12 exams and all the assignments she has on her plate, often not getting to bed until midnight or after. In between all this she squeezes in time to see her boyfriend and friends.
Does this sound like someone suffering Gardasil injuries?
Shania had 2 of the 3 Gardasil injections. I believe if she had had the full 3 shots she would not be here today. Things were so bad five years ago, I never believed I’d see this day. Look how far she’s come!
I hope this gives hope to other Gardasil victims that they, too, might also get their lives back eventually… Shania is living proof that it can happen. It HAS happened.
AAVP, together with law firm Almodóvar & Jara, filed the first of a long series of lawsuits for damages caused by HPV vaccines. The complaint is filed in the High Court against health authorities and vaccine manufacturers.
The process of trying to find justice now begins for one of the Valencian girls who suffered an adverse reaction after the second shot of Gardasil in 2009. Spanish families whose lives have been adversely impacted by HPV vaccines have organized as the Association of Affected People by HPV Vaccine (AAVP www.aavp.es) to assist others in similar circumstances.
The well documented lawsuit is based on violations of the fundamental right to informed consent prior to medical interventions which all citizens have.
Parents whose daughters are vaccinated with Gardasil are not informed beforehand of the possible risks their daughters may suffer, despite the fact there are numerous reports in Spanish, European and American databases. Furthermore, most of the adverse reactions these girls suffered are included in the brochure/leaflet of the product.
The introduction of HPV vaccines into the market without their real effectiveness being known is another issue. The effectiveness has not sufficiently been proven and will not be demonstrated for decades.
Much of the damage these vaccines are producing is being hidden, despite the fact that pharmacovigilance systems around the world are collecting numerous reports of similar reactions.
Moreover, the Spanish Health Ministry withheld information from affected families by denying that the damage the girls suffered was legitimate and previously known via similar cases being reported to health authorities in various countries.
The Spanish Ministry of Health, Sanofi Pasteur, and Merck, Sharp and Dohme (MSD), producers of Gardasil®, human papillomavirus vaccine, have a responsibility to report accurately and in a timely manner all data available at the time.
Health authorities around the world are trying to deny any causal relationship between HPV vaccines and adverse events occurring after vaccine use. In some cases, authorities say that the new medical conditions are psychological. This is a paradox because if people in different times and different places suffer a similar adverse reaction, it is undeniable that the cause is the vaccine.
The damage these girls have suffered and many continue to suffer were not all included in the leaflet at the time of injection. Some of them were included later. Others continue without being warned.
Based on data that the AAVP has examined, the number of suspected deaths and serious sequelae left behind after human papillomavirus vaccines is completely unacceptable.
As stated in the case filed, health authorities do not investigate the facts and their attitude is favoring manufacturers. They even accused the victims of suffering psychological disorders, which is not true.
This first case will be followed by another four within two months. The firm will continue to file additional cases, not only against Gardasil® but also Cervarix®, the other brand of the HPV vaccinemanufactured by GlaxoSmithKline.
3 July 2014: As a result of continued investigations regarding clinical trials involving HPV vaccines in India, more allegations of unethical conduct have been lodged against Merck. These allegations pertain to Merck’s recent trials of the new V503 HPV vaccine, a proposed nine valent HPV vaccine. A complete report of the investigation results written by Dr. Anand Rai, Kelly O’Connor, Amoli Tuli, and Anisha Bhattacharya is now a matter of public record. (Link to report)
The additional allegations of multiple ethics violations were added to a currently ongoing Supreme Court Case via an affidavit added as an addendum to the brief previously prepared regarding the ’demonstration projects’ conducted by a U.S NGO PATH in India beginning in 2009. The deaths of subjects during the ’demonstration projects’ resulted in a government-ordered enquiry and suspension of all HPV vaccine trials in India pending further investigation. This suspension was effective as of April 2010 and is still in effect.
Ultimately, the suspension and subsequent investigations allowed advocates in India to take their case all the way to the Supreme Court. The petition for the case was formally admitted by the judges on January 7, 2013. By September 2013, the court had issued notices to all participants involved while the Indian Parliament issued a scathing comment condemning all organizations involved in the so-called ’demonstration projects’ calling them a case of child abuse expressly carried out to create a market for the two companies – Merck and GlaxoSmithKline.
According to new allegations, Merck ignored the suspension of HPV-related clinical trials and continued with a phase III trial of the yet-to-be-approved investigational HPV vaccine called V503, which theoretically adds protection against 5 types of HPV to the ones already included in their current HPV vaccine, Gardasil.
Allegations of Merck’s Misconduct
The supplemental affidavit submitted to the Supreme Court of India states that Merck and/or their representatives committed the following violations of basic human rights:
1. Respondent No. 8, MSD Pharmaceuticals Pvt. Ltd. and its affiliate companies in respect of pre-licensure trials with investigational HPV vaccine V-503.
2. Pre-licensure Phase III trials were carried out at many centres in India. One of these centres was Indore. In Indore this vaccine was administered to 44 children, boys and girls. A field study with the participants was carried out by Dr. Anand Rai and others and is detailed in the Annexure.
3. The timing of this trial was such that vaccination was carried out during the same period when Respondent no. 1, The Ministry of Health and Family Welfare, had asked all HPV related studies to suspend vaccination. As such then this was a violation of the government orders.
4. The Annexure also lists in detail all the problems with this trial on a case by case basis, some of them are summarized below:
a) This clinical trial was not preceded by any trial among adults thereby violating the Drugs and Cosmetics Act. This trial had the approval of the Respondent No. 2, The Drugs Controller General of India (DCGI), who violated the law that his job specifically asked him to uphold. The petitioners have complained to the court that is the second time regarding HPV vaccines the DCGI bestowed this favour on Merck and its associates.
b) The trial used middle men and women acting as agents of the investigator who went around residential areas recruiting subjects in complete violation of all national and international guidelines.
c) The trial was carried out at a government hospital using government stationery and seal even though this was a privately sponsored trial of the company thereby misusing the trust parents place in the governmental vaccination programmes.
d) The parents and children were told that they were getting a successful vaccine from abroad free which would otherwise cost Rs 10,000. This was a blatant lie as this vaccine was not approved for marketing anywhere in the world. Also this constituted undue inducement to recruit children to this trial.
e) None of the participants were informed that they were participating in a clinical trial.
f) Economically vulnerable sections and those from scheduled castes and minorities were recruited for the trial, those who would not be able to afford the vaccine if and when it is marketed; thereby the trial further violated all laws and guidelines in this regard.
g) Merck listed history of allergic reaction that required medical intervention, currently enrolled in another clinical trial, subject is pregnant, subject is immunocompromised or has taken immunosuppressants in the last year, subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial and subject has history of positive test for HPV as exclusion criteria for this clinical trial. No examinations of the children who were selected for participation were undertaken prior to administration of the V503 vaccine.
h) There was no placebo involved in this trial, simply three different lots of V503, despite the fact that one purpose of the trials was to detect potential safety issues.
i) From the beginning to end, there was no examination of the children for their health status, and even though the trial was supposedly carried out to determine the safety of the vaccine not even fever post vaccination was recorded.
j) No medical care was provided for the health problems of the children nor were they provided any compensation. The study found many children who continue to suffer new medical problems even as late as 2013. Out of the 12 individuals interviewed, 4 have experienced health problems after the vaccine, such as mood swings, persistent stomach aches, dizziness, late onset of periods and severe anaemia. One boy whose family was interviewed has suffered extreme weight loss.
k) Though the investigation covered only the trial centre at Indore the entire list of trial centres is placed in the supplemental affidavit for information. In all hundreds of children have been affected in India.
One would think all of the complaints filed against PATH and Merck during the ’demonstration projects’ for Gardasil would have caused them to be on their best behavior. But apparently, when the government officials in India called a halt to any trials relating to HPV, Merck thought the decree did not apply to them. Either that, or they believed themselves powerful enough to be above the law.
Whatever the motivation, it appears hundreds more economically disadvantaged children and their families were put at risk by their participation in a clinical trial they were not told they were taking part in.
Compound this disregard for informed consent with participants being told they were priviledged to receive a successful and very expensive vaccine from overseas. Nevermind the fact that this ’successful vaccine’ had not been approved for use in any country in the world.
The people of India are not the only ones who may suffer the effects of this particular set of clinical trials. What ’results’ will Merck report to the rest of the world on this set of trials where the exclusion criteria was apparently ignored?
What ’results’ will Merck report to the rest of the world when no adverse events were recorded? One can certainly assume the adverse events which apparently were not recorded will no longer exist.
Will pretending these new medical conditions did not happen allow Merck to report their new V503 HPV vaccine is safe?
Is Merck above the law?
Will Merck be allowed to ignore the international laws protecting the basic right of informed consent prior to participation in clinical trials? Will Merck be allowed to continue to exploit economically disadvantaged people then extrapolate the resulting ’conclusions’ to the entire population of the world?
One can only hope the Supreme Court in India decides to protect the health and well-being of their young people by responding to the complaints of the organizations who put forth the allegations in a manner which will stop these types of abuses from ever happening in their country again.
By doing so, India’s Supreme Court Judges could help protect all of the world’s young people.
The Supreme Court of India has scheduled the final hearing of this case for August 12, 2014. The Court’s decision should be rendered on that date.
Whatever the ultimate outcome, advocates around the world will be watching.
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