Another excellent option to use in preventing Ebola disease.
This clip has been made by two of our, Featured Doctors, and in this case a husband, and wife team. Thank you Allyson, and Jeff.
Allopathic medicine borrowed the idea of vaccinations from Homeopathy. A number of success stories in regards to preventing modern-day disease, and healing the body of chronic disease. Learn details in the clip below.
Using Homeopathic Immunization to Prevent Ebola Virus Disease
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.
“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.
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.”
This article in it’s entirety, is complements of www.SaneVax.org
Please sign the petition, no matter where you reside on the globe. Place your country’s two letter abbreviation in front of the postal code, if you do not live in France.
By Norma Erickson
29 September 2014: IPSN, the Institute for the Protection of Natural Health (Institut pour la Protection de la Santé Naturelle), based in Brussels, in conjunction with French oncologist and surgeon Professor Henri Joyeux, launched a French petition against the HPV vaccines Gardasil and Cervarix.
The petition is already doing quite well with over 316,000 signatures (and steadily rising) in a little over a week. Originally, the goal was to reach 500,000 signatures then submit the petition to government authorities in France. However, interest in this petition has expanded to other countries where medical professionals, scientists and medical consumers are also seriously questioning the sanity of universal HPV vaccination programs.
Due to so many requests from people outside France who wished to sign the petition, Professor Joyeux and the Institute for the Protection of Natural Health have agreed to open their petition to every country in the world. Please consider demonstrating your solidarity with the people of France by adding your signature to this petition.
If you have already decided HPV vaccines are of questionable value please sign the petition here.
You need only fill in 4 boxes: your first name, last name, postal code (if you do not live in France, please add the two letter abbreviation for your country before the postal code, eg. GB for the UK, DE for Germany, US for the United States, etc…) and your email address.
The boxes to tick after that are to indicate: 1) whether you want to be kept informed (in French of course) of petition progress and 2) whether you would like information (in French) on natural health. Once you have done this, simply click on the green box to submit your signature.
The organizers of this petition understand that HPV vaccines have not been proven to be safe, affordable, necessary or effective. Professor Joyeux explains exactly why in the video text below. The video is in French and can be accessed at the end of this article. Helen Kimball-Brooke has kindly provided the English translation of the content.
Good morning. This is Professor Henri Joyeux, French oncologist and surgeon. I am writing to you because the French High Council for Public Health has recently published a report recommending first of all:
However, just like any medicine prescribed to a person in good health and even more so to children, the two current HPV vaccines, Gardasil® and Cervarix® bring with them the risk of serious adverse effects.
In addition, the authorities fail to mention to us that the protection against cervical cancer conferred by these vaccines is not 100%. In fact, protection from Gardasil® and Cervarix® is no more than 70%, leaving 30% risk of cancer.
Even if we could be certain of their effectiveness, these anti-viral vaccines should really only be administered to high-risk populations.
The HPV virus is transmitted primarily through sexual relations. Do not allow the authorities to apply an inappropriate health measure to your children!
Sign our petition demanding a moratorium on these vaccines which should not be imposed in our schools without providing prior comprehensive and transparent information to the parents.
There are very good reasons to be deeply concerned about this campaign. According to Professor Guy Vallancien (a supporter of this vaccine), urologist, head of department at the Institut Montsouris in Paris and member of the French National Academy of Medicine,
“Analysis of the pharmacovigilance data for this vaccine revealed 26,675 serious adverse effects, 113 of which were cases of multiple sclerosis. In France alone, 435 cases of serious adverse effects, including 135 autoimmune diseases, 15 of which were cases of multiple sclerosis, have been reported to the national network of regional pharmacovigilance centres and the vaccine manufacturer.”
http://sante2020.blog.lemonde.fr/2014/04/01/gardasil-nous-revoila/
Many of these young schoolgirls, now disabled for life, were unnecessarily vaccinated with Gardasil when they were not in any way part of the high-risk population.
Sign the petition to protect your child from the same fate.
In Austria, following the death of a young woman vaccinated with Gardasil, a report was published indicating that the long-term effectiveness of such a vaccination would be “totally negligible”. The Austrian Health Minister, Dr. Andrea Kdolsky, then decided to withdraw HPV vaccines from the official schedule, to stop reimbursing them and to encourage regular Pap smear screening instead.
On the 24th of January 2008, the European Medicines Agency (EMEA) announced that some women previously vaccinated with Gardasil had died. It is therefore beyond imprudent to want to vaccinate all children, across the board, against HPV: it is totally irresponsible.
Sign our petition urgently.
As early as February 2007, interviews aired on American television reported serious complications, told the tragic stories of living Gardasil victims and showed photos of young women who had died following vaccination with Gardasil.
In 2013, the Japanese authorities decided to stop recommending this vaccine.
In France, a lawsuit was filed against Sanofi, the manufacturer of the vaccine, by young Océane Bourguignon and other young girls. They all suffered extremely serious brain and spinal cord damage after being vaccinated with Gardasil.
“We do not yet know its effectiveness. We do not yet know the risks” warned Dr. Jean-Paul Hamon, chair of the French Doctors Association, on French TV channel TF1.
Video clip: “We do not yet know its effectiveness. We do not yet know the risks. The only safe and effective method is Pap smear screening. And now we prefer to invest €300M into something whose effectiveness and risks we don’t yet know.”
This is 100% true. If you or your child think that you may be infected with HPV, go to your doctor and get a smear test. If precancerous lesions are found, they can definitely be treated. But above all, no vaccine! It could even increase your risks of getting cancer.
Two analyses of the vaccine’s impact on women already infected with HPV before they were vaccinated revealed an increase in the number of high-grade precancerous cervical lesions in the Gardasil® group compared with the unvaccinated placebo group. Fortunately, the difference was not significant but this proves that in any case, the vaccine is useless if you are already infected, which is not surprising.
The worst however is that the long-term effectiveness of the vaccine, even in persons not infected at the time of vaccination, is unknown. The French High Health Authority itself writes as follows on Gardasil®:
“The effectiveness of HPV vaccination on the incidence of cancerous lesions in the genital area can only be established retrospectively after a number of years because these pathologies develop very slowly.”
Do you want your children to be Guinea pigs? It is therefore totally premature and potentially dangerous to impose a widespread vaccination campaign in French schools, especially when the recipients are young and very vulnerable children.
This is what the experts are saying: Abby Lippman, epidemiologist at McGill University in Canada and specialist in women’s health:
“Neither Gardasil® nor its competitor Cervarix® has yet demonstrated its effectiveness in preventing cervical cancer. According to these specialists, “we do not yet know if the vaccine will result in a reduction in the number of cancer cases.”
According to Lucija Tomljenovic, research scientist working on the neurotoxic effects of vaccine adjuvants at the University of British Columbia in Canada,
“The vaccine is no more effective than other methods of prevention but carries far greater risks.”
Not only can it cause accidents but widespread vaccination of young girls may result in a drop in Pap smear screening which we know can save lives. Certain women will think “I am vaccinated, I am protected” which is in fact scientifically false.
This is why in March 2014, more than 700 French doctors signed a petition demanding a Parliamentary Committee of Enquiry into this vaccine. One of them was pulmonologist Dr. Irène Frachon, courageous revealer of the Mediator scandal. These doctors have already instilled fear in the government.
Now it is families who are trembling with fear for their children. It is now our turn to triumph by making this message go viral and gathering millions of grassroots signatures on this petition.
Of course the Big Pharma lobbies will put up a serious fight. We know them well with their enormous advertising resources. France represents a massive market for them every year. The vaccine manufacturers will pull out all the stops to make us think that their products are safe… grinning all the way to the bank.
But our children’s lives are worth more than their profits!
Why should your children run even the slightest risk when this disease is easily detectable and curable with regular screening by a gynecologist? They shouldn’t!
With the Institut pour la Protection de la Santé Naturelle (Institute for the Protection of Natural Health), we can be millions to say NO TO THESE VACCINES in our schools, NO to vaccinating 9-year-old children with a product which may not be effective and is potentially dangerous, even deadly.
If millions of us sign, the authorities won’t be able to ignore us, but to reach this figure, each of us must sign this petition immediately and circulate this appeal as far and as wide as possible.
Dr. Bérangère Arnal, OB-GYN and mother of 13-year-old Eve, has stated that her daughter will not receive the HPV vaccine but will be informed and regularly screened if necessary. This is the advice I give to all families.
In high-risk populations, regular Pap smear tests every three years has resulted in a 70% reduction in the cervical cancer mortality rate, but this information is concealed from the general public.
The (of course very profitable) target of the lobbies is to vaccinate all schoolgirls before then vaccinating young boys of the same age, as soon as possible, and to make the vaccination mandatory in French schools.
We do not agree with these objectives which we deem to be “false public health”. We can make them withdraw this plan by saying NO to this abuse, along with millions of others. But to achieve this, every responsible French citizen must circulate this petition as far and as wide as possible. I am therefore counting on all of you to sign the petition and to send it as soon as possible to all of your contacts.
Thank you from the bottom of my heart, in the name of our children’s health.
Professor Henri Joyeux.
Institut Pour La Protection de la Santé Naturelle
The right to alternative treatment
NO to widespread vaccination of children against HPV
Petition
For the attention of The President of the French Republic, The French Minister of Health and Social Affairs, And the French Minister of National EducationMr. President, Mme Health and Social Affairs Minister, Mme. National Education Minister,
On the 15th of September 2014, the French High Council for Public Health published a statement recommending that:
This plan has aroused very deep concern in the French people and the medical profession.
There are a very large number of us who fear that our schools are being used as a front for a widespread HPV vaccination campaign targeting our children, without providing families transparent information on the effectiveness and risks of this vaccine and without allowing them to consider the pros and cons.
May we remind you that the analysis of pharmacovigilance data revealed 26,675 cases of serious adverse effects connected with these vaccines, including 113 cases of multiple sclerosis.
May we also remind you that the only method which has been proven to prevent cervical cancer is the Pap smear. If precancerous lesions are found, they can then be treated.
The vaccine however does not confer 100% protection, far from it. All medical sources concur on this point. It is a very dangerous situation if vaccinated individuals go off thinking that they are fully protected.
We the undersigned therefore demand that the plan for widespread HPV vaccination in French schools be stopped:
This is the only way to protect a large number of children from unnecessary accidents and considerable suffering. You will also be making a step towards maintaining the trust of parents and keeping necessary peace in our schools.
Yours sincerely,
Number of Signatures
References:
(1) http://sante2020.blog.lemonde.fr/2014/04/01/gardasil-nous-revoila/
(2) http://lci.tf1.fr/science/sante/papillomavirus-un-vaccin-des-neuf-ans-a-l-ecole-pour-les-jeunes-8485665.html
(3) http://www.has-sante.fr/portail/jcms/c_1710328/fr/rappel-dinformation-sur-la-vaccination-contre-les-papillomavirus-humains-par-le-gardasil
This article in it’s entirety, is complements of www.SaneVax.org
Just as in many posts before, I have been pondering over some thoughts that have been coming to mind. I have felt at a bit of a loss as to what justice I can do for these concerns.
As I have spent countless hours researching, I have been stunned at how vast an issue this is.
I am speaking of the Many parents, and foster parents, and others that are innocently imprisoned every year. They are wrongly accused for harming or murdering a baby or child. I cannot imagine a worse assault to one’s character. These assaults happen to innocent people, on a regular basis, and they stretch world-wide.
How does this happen to these innocent people? It happens right under our noses in our own communities, because we put our faith in man. The supposed scientific research that doctors, and nurses tell the local law enforcement, and the forthcoming pleas from these parents fall on deaf ears. 
Can you imagine having your child seizure, have a fatal allergic reaction, incur brain swelling, and then be accused of murder, and sent to prison. This is what happens, and now you can grieve their loss, and have your support system torn away, and sit alone in a cell.
The research that is used is old, and faulty, and now there are talk shows that receive dollars to dramatize the events of a shaken baby.
Interestingly, the modern evidence reveals that a shaken baby cannot receive the injuries that are accepted by law enforcement in these cases. Many individuals are innocent along the way. Trusting the Superior advice of a physician.
Well, let’s not be in the dark any longer. There are those that have research, and know how these injuries take place, but it is covered up because of the tie to vaccines, and probably other prescriptions as well. How often do these injuries take place within 30 days of a vaccination?
If your child were to have these reactions in front of the doctor, then another description would be said, one being: unknown cause.
Silly isn’t it, let’s call it what it is. Every parent, babysitter, boyfriend, girlfriend, nanny, grandparent or foster parent that is caring for a child following a vaccination is at risk of being accused of shaken baby syndrome, if that child has a similar reaction above, and no one else is there to witness it. These are the extremes that pharmaceutical companies will go to protect their investments.
It makes me sick that there are individuals that walk this earth, and will hurt others to this extent, including the life of the child, just for monetary gain.
Everyday, day in and day out, our fellow man sits, and waits to be heard, and rescued.
Let’s remember the Golden Rule, and do unto others as we would have them do unto you.
Let’s be wise to this, and do all we can to free the innocent.
By Donna Eliassen, Australia
Part 1 – The nightmare begins: http://sanevax.org/shania-from-australia/
Part 2 – A promising update: http://sanevax.org/update-on-shania-the-flyer-mandurah-western-australia/
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.
Donna Eliassen (Shania’s mum) This article, in it’s entirety, is compliments of SaneVax.orgBy Alicia Capilla (President of AAVP)
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.
This article, in it’s entirety, is compliments of SaneVax.org.
By Norma Erickson 
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.
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?
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.
