Tag: ADEM

HPV Vaccines: Time for Science#iBelieve#vaccines#HPV

jv Leave a comment

SaneVax-Featured

 

By Norma Erickson

According to the World Health Organization (WHO), as of January 2014 fifty-two countries have included HPV vaccines, either Gardasil or Cervarix, in their national immunization programs. During the last five years, the SaneVax Team has been contacted by representatives from 24 of those countries who are seeking to understand the vast array of new medical conditions occurring in the wake of these programs.

1.2014-WHO-Countries-with-National-HPV-Vax-programs(Note: SaneVax has been contacted by multiple people in Australia, Argentina, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, India, Ireland, Israel, Japan, Malaysia, Morocco,  New Zealand, Norway, Peru, Scotland, Spain, Sweden, Switzerland, the United Kingdom and the United States – all requesting further information on HPV vaccines and vaccination programs.)

Why would so many countries contact an organization dedicated to the promotion of only safe, affordable, necessary and effective vaccines and vaccination programs in such a relatively short period of time? Let’s take a look at the science.

In 2006, when the FDA approved the first HPV vaccine (Gardasil) for cervical cancer prevention they should have known that HPV does not cause cervical cancer without other risk factors being involved. They should have known that the endpoints chosen to evaluate the efficacy of the vaccine were not sufficient to prove future cervical cancer prevention because ASCUS and CIN1/2/3 frequently resolve on their own, or can be detected by currently available tests (pap smears) and treated safely and effectively prior to progression to cervical cancer. They should have known that allowing the manufacturer to use a reactive aluminum adjuvant as a ’control solution’instead of an inert placebo could potentially mask adverse effects making the vaccine appear more safe than it actually is.

Any one of these facts should have raised questions about the practicality of utilizing HPV vaccines in any cervical cancer prevention program. Apparently the facts above were either not known, or they were ignored. Gardasil was awarded fast-track approval despite the fact there was no cervical cancer crisis in the United States. A short time later, Cervarix was approved for the same indication.

Since health officials at the FDA are apparently ignoring scientific facts medical consumers need to be aware of the science, or lack therof, behind HPV vaccines.

Does HPV cause cervical cancer?

HPV-real-risk-GSKAccording to WHO, only 0.15% of people exposed to any high risk HPV types will ever develop cervical cancer. We do not have a publication date on the chart to the right, so let’s assume this is new knowledge, information which the FDA officials responsible for the fast-track approval of Gardasil did not have when they made the decision to approve the vaccines for cervical cancer prevention.

Medical consumers need to know that according to the World Health Organization 99.85% of those exposed to oncogenic types of HPV will never develop cervical cancer.

IF the FDA did not know this prior to approving HPV vaccines to ’prevent’ cervical cancer, they are most assuredly know it now. Consider the following quote from an FDA/CBER (Center for Biologics Evaluation and Research) meeting held on September 19, 2012 to discuss the use of human tumor cells in vaccine production (verify on pages 91-92 of this transcript):

“However, even tumor induction by acute oncogenic viruses requires additional oncogenic events. The best example is the Human Papillomavirus, where even infection with a high risk of Papillomavirus types is not sufficient to induce cervical cancer. Mutation in other genes and perhaps also epigenetic events are required. If a single infection-induced cervical cancer after infection with HPV, say, 16, then teenagers will be getting cervical cancer. And as we know, cervical cancer is a disease of older people”.

So, there you have it – even infection with a high risk strain of papillomavirus types is not sufficient to induce cervical cancer. Since at least September 2012, FDA officials knew infections with high-risk HPV types will not induce cancer without genetic mutations and/or other epigenetic (relating to or arising from nongenetic influences on gene expression) events occurring also.

Did this cause the FDA or CDC to re-examine the usefulness of HPV vaccines? No.

Were clinical trial endpoints valid?

Prior to the marketing push for HPV vaccines, CIN1/2/3 were known as abnormal cells – something that needed to be observed until treatment was required. Now, they are almost always referred to as ‘pre-cancerous’ lesions. This serves no purpose other than to strike fear into the heart of almost any woman on the face of the planet. The nature of the abnormal cells has not changed, simply the terminology. No mention is made of the fact that CIN1, CIN2 and often CIN3 abnormal cells revert to normal cells without medical intervention.

Not many people are aware of the fact that most CIN1 lesions go away on their own within two years. 25-50% of CIN2 lesions regress on their own within the same two year time frame. According to the International Agency for Research on Cancer (IARC), World Health Organization, the results of a pooled analysis of studies published between 1950 and 1993 indicated only 12% of CIN3 lesions progress to invasive cervical cancer.

Consider the following quote from Chapter 2 of the IARC’s COLPOSCOPY AND TREATMENT OF CERVICAL INTRAEPITHELIAL NEOPLASIA: A BEGINNER’S MANUAL states:

“Despite women’s frequent exposure to HPV, development of cervical neoplasia is uncommon. Most cervical abnormalities caused by HPV infection are unlikely to progress to high-grade CIN or cervical cancer, as most of them regress by themselves. The long time frame between initial infection and overt disease indicates that several cofactors (e.g., genetic differences, hormonal effects, micronutrient deficiencies, smoking, or chronic inflammation) may be necessary for disease progression. Spontaneous regression of CIN may also indicate that many women may not be exposed to these cofactors.”

Please note this manual was designed to teach medical and nursing personnel in developing countries where diagnostic and therapeutic expertise is not readily available. In other words, the progression from HPV exposure to potential development of cervical cancer is similar in both developing countries and developed countries. It also indicates that several cofactors (risk factors) may be needed for HPV exposure to progress to abnormal lesions, much less cervical cancer.

Surely, FDA officials were aware of the information contained in a beginner’s manual to treatment of so-called ‘precancerous’ lesions published by the World Health Organization. If not, they certainly should have been. Nevertheless, they allowed these very same abnormal cells which typically revert to normal on their own to be used to evaluate the efficacy of HPV vaccines against cervical cancer.

Medical consumers need to know, according to WHO only 1% of CIN1, 1.5% of CIN2 and 12% of CIN3 progress to invasive cervical cancer. This is in developing countries. In countries where pap smears are routinely administered the percentages should be much lower. Could using these abnormal cells as endpoints in clinical trials artificially inflate the predicted efficacy of HPV vaccines against cervical cancer? Absolutely!

Why not use a true placebo during clinical trials?

When conducting scientific experiments to evaluate a new substance, standard practice is to have at least two groups – one group using the substance being examined and the other using a placebo. This way, the scientific team can evaluate the effects and safety of the new substance by comparing both groups’ results at the end of the study.

The definition of placebo is “a substance having no pharmacological effect, but administered as a control in testing experimentally or clinically the efficacy of a biologically active preparation.”

There is no doubt about vaccines being a biologically active preparation. But, how about aluminum – one of the major ingredients in the proprietary AAHS solution which Merck was allowed to use as a control solution in the vast majority of clinical trials for Gardasil?

A quick search of PubMed, using the terms ‘aluminum toxicity human’ returns 1620 papers on studies conducted as early as 1966. If you narrow the search to ‘injected aluminum toxicity’ you come up with 116 papers published as early as 1974. Refine the search even further to ‘injected aluminum toxicity human’ and you still get 31 scientific papers published between 1979 and 2014.

It is extremely difficult to believe the FDA officials responsible for reviewing Gardasil’s application for approval did not know that aluminum compounds were potentially toxic to humans. Yet, they accepted the use of a proprietary (meaning no one knows what was included other than aluminum) AAHS aluminum adjuvant as a control solution instead of an inert placebo.

FDA officials knew, or should have known, that clinical trials conducted in this manner proved nothing other than the fact that Gardasil was no less dangerous than the new AAHS adjuvant which had never been tested for safety in humans. FDA officials ignored the fact that over 70% of all clinical trial participants reported new medical conditions after the trials. (Verify here) One can only speculate as to why this fact did not raise a huge red flag, but apparently it did not.

The FDA could certainly not use the excuse that it would be unethical to withhold vaccination from any of the clinical trial participants because there was currently no ‘comparable’ vaccine available. Why then, did they not require a real placebo?

Is the FDA ignoring new scientific evidence?

Below is a list of scientific information presented to government health officials around the world. None of the presentations below have brought forth a response from FDA officials. Please keep in mind this is by no means a complete list; it is simply a sample:

How long are medical consumers supposed to put their faith in an agency that repeatedly ignores standard scientific methodology, not to mention scientific evidence? Medical consumers need to remember every single medication that has ever been pulled from the market was first approved ‘safe and effective’ by the FDA. Can you trust them with your life?

Remember – Research before Consent – you can’t un-vaccinate.

Article compliments of SaneVax.org

Spotlight on Gardasil in France#Vaccines#HPV#iBelieve

jv Leave a comment

SaneVax-Featured

By Helen Kimball-Brooke MARH, guest author

A press conference on the Gardasil vaccine was held in Paris on Wednesday the 2nd April 2014 at the local offices of the European Parliament, a short walk from the French National Assembly.  It was organised by MEP Michèle Rivasi (Vice-Chair of the Greens/European Free Alliance group) who has held meetings in the past on pharmacovigilance in Brussels and other press conferences on the aluminium salts used as adjuvants in vaccines, in Paris.  Three members of EFVV (the European Forum for Vaccine Vigilance) attended the conference: myself, Françoise Joët from the French group ALIS and Dr. Françoise Berthoud, retired homeopathic paediatrician from Switzerland.

French Press Conference

Aside from Michèle Rivasi, the speakers included the parents of two HPV-vaccine victims: 18-year-old Marie-Océane Bourguignon who after receiving two doses of Gardasil at age 15 now suffers from multiple sclerosis (MS) and Orianne Lochu, age 21, a former first-year medical student now struggling with severe macrophagic myofasciitis, an illness thought to be linked with the aluminium adjuvants in vaccines.  Both HPV vaccines, Gardasil and Cervarix, contain aluminium salts.  Within months of her jabs, Océane, the only French HPV vaccine victim for whom the link to the vaccine has been officially recognised by a Medicine Injury court, temporarily lost both her sight and the use of her legs after being hospitalised for what appeared to be either acute disseminated encephalomyelitis (ADEM) or multiple sclerosis.

Océane’s case was originally heard by the Bordeaux Commission de Conciliation et d’Indemnisation or Medical Accident Arbitration and Compensation Committee, set up by the Ministry of Justice with members appointed by the local Public Health Authority.  As of the judgement in September 2013 she was awarded compensation amounting to 50% of her claim but given that Sanofi-Pasteur were clearly incriminated in the case and thinking of all the other victims, her parents chose to forfeit the compensation by filing charges in the criminal courts.  The criminal court case is still pending.

The parents of both girls expressed anger and frustration over the way they had been treated: refusal by the medical profession to acknowledge that their daughters’ illnesses had been triggered by the vaccine, lack of support and treatment for the girls’ ailments, even suspicion and ostracism for having dared to blame the vaccine.  The experience has been all the more difficult for Orianne’s parents who are medical professionals themselves: her father is an anaesthesiologist and her mother a nurse.

Océane’s lawyer, Maître Jean-Christophe Coubris, also defending over 100 other French HPV-vaccine victims, was another speaker, as was Serge Rader, a pharmacist who has done research on the widely varying prices of vaccines across Europe, and Elena Pasca, a philosopher, member of the board of Sciences Citoyennes and author of a blog called Pharmacritique, who discussed the conflicts of interest inherent in the development and marketing of these vaccines.

Others present included French medical consultants Profs. Authier and Gherardi, doing research on the aluminium salt adjuvants in vaccines at the Henri-Mondor Hospital in Créteil, a Parisian suburb, and consultant Dr. Laurent Belec, head of the virology laboratory at the Georges Pompidou European Hospital in Paris.  The sudden withdrawal in 2013 of the funding for the important work of Authier and Gherardi was the topic of another press conference organised by Michèle Rivasi last year.  Their funding was only re-instated after two members of the NGO victim support group E3M went on a hunger strike.

Professor Christopher Shaw

The speakers of honour however were Drs. Christopher Shaw, neurologist, and Lucija Tomljenovic, PhD, from the University of British Columbia, Canada, known for their research on Gardasil and the dangers of its adjuvants.  Currently doing research with Professor Yehuda Shoenfeld in Tel Aviv, Israel, on vaccine adjuvant-induced autoimmune diseases, they spoke of the effects on the body of the aluminium in vaccines.  It has been shown that aluminium migrates through the body to the brain, where it accumulates, potentially causing many adverse effects: convulsions, fainting spells, Guillain-Barré syndrome, transverse myelitis, facial paralysis, chronic fatigue syndrome, autoimmune diseases, pulmonary embolisms, macrophagic myofasciitis, pancreatitis and even death.

Lucija Tomljenovic

 Dr. Tomljenovic demonstrated how these vaccines were rushed prematurely to market.  In the USA, the FDA approved the vaccine very fast, reflecting, in her opinion, the flaws and incompetence which are now sadly a characteristic of the organisation.  Development of cervical cancer from HPV infection is in fact very slow and 90% of HPV infections resolve of their own accord within three years.  The duration of follow-up in the clinical trials was only 4.5 years for Gardasil and 8.4 years for Cervarix but given the slow growth of these cancers, at least 15 if not 20 years would really be needed to establish accurate efficacy. The manufacturers have nonetheless claimed 70% efficacy based on these short-term trials, and Sanofi-Pasteur, who market Gardasil for its manufacturer Merck, have even claimed ‘up to 100%’ efficacy while true vaccine efficacy could be as low as 16.9%.

STIKO, the German Standing Vaccine Committee’s flawed assumption that the vaccine would confer lifelong protection of 92.5% led to the decision to reimburse the HPV vaccine in Germany and incited many German doctors to recommend it.  Since its introduction 7 years ago, nearly 2 million young French women between the ages of 13 and 26 have received at least one dose of Gardasil, reimbursed at 65% by the Social Security, even though its effectiveness has not yet been proven and is highly controversial.  There are in fact over 100 strains of HPV but Gardasil contains only antigens from strains 6, 11, 16 and 18, considered the most oncogenic.  Strains 16 and 18 are responsible for 70% of cervical cancers which is why these are the only two in Cervarix but infections with these two strains also seem to be less common in Europe.  In fact, cervical cancer represents only 1.7% of all cancers in France so it is not actually a public health problem there anymore.

On the 4th of February 2014 however, President François Hollande announced that as part of his ‘Cancer Plan’, he wanted HPV vaccine uptake amongst young French women to double over the next five years.  This came as an enormous shock to the parents of the 10 girls with very severe neurological complaints, who by November 2013 had already initiated legal proceedings against both Sanofi Pasteur and ANSM, the French national medicines safety authority.

To quote Dr. Tomljenovic:

‘Just as pizza-bearing cheerleader drug reps are a poor substitute for medical education, pharmaceutical lobbying is a poor substitute for well-reasoned public health policy-making….Is it ethical to put young women at risk of death or a disabling autoimmune neurodegenerative disease at a pre-adolescent age for a vaccine that has not yet prevented a single case of cervical cancer, a disease that may develop 20-30 years after exposure to HPV, when the same can be prevented with regular Pap screening which carries no risk?’

The number of HPV vaccine victims continues to grow in France and worldwide, with some countries taking a more cautious stance: Austria refused from the start to include the HPV vaccine in its vaccination schedule and during 2013, under pressure from victims, the Japanese Ministry of Health, Labour and Welfare withdrew its recommendation for the HPV vaccine.  Shortly after the press conference in Paris, it was announced in Japan that instead of reinstating the HPV vaccine recommendation, the authorities would hold off for at least another year.

On the 30th March, only three days before the press conference, it was reported in French newspaper Journal du Dimanche that 420 French doctors plus nearly another 300 pharmacists, midwives and other medical professionals had signed a petition demanding a parliamentary mission to reassess Gardasil, claiming that its effectiveness is limited (only 20% according to clinical trials) and its cost exorbitant. They also fear that the vaccine may mislead women into thinking that a Pap smear, whose effectiveness has been proven, is not necessary.  As of late May 2014, there were nearly 1200 signatures on the petition.

Of course a counter-petition was also launched by seven scholarly medical groups affirming the benefits of the vaccine but speaking of cost: what in fact is the actual cost of this HPV vaccine campaign in France?  Mr. Rader informed us that a single dose of Gardasil costs €123.44, compared with prices ranging from €6.50 to €57 for other French vaccines, the prices of which have increased as new vaccines were introduced over the years.  The three jabs required would therefore come to a whopping total cost of €370.32 per individual.  The duration of protection conferred by the initial vaccination is still not known so the overall cost would increase if boosters were required.  A ‘catch-up’ period could generate a cost to the French Social Security of a shocking €926 million and in subsequent years, the annual cost would be €148 million.  What incites more questions however is that a single dose of Gardasil costs only €60.50 in Italy and the Rotavirus vaccine recently recommended for all new-borns by the French High Council for Public Health, costs €54.60 per dose, including tax, compared with only $1 per dose in India.  Why do vaccines cost so much in France?

Pap smears, costing €15.40 each in France, remain the best and most effective way to fight cervical cancer.  The speakers therefore questioned why the French government was so intent on pushing Gardasil whose effectiveness is debateable and will not be known for 15 or more years, let alone its excessive cost.  An indecent communication campaign with lobbying and aggressive advertising was apparently engaged a number of years ago to promote this vaccine.  The adverts played on the fears and guilt especially of mothers and in 2010, one of them was even banned for ‘lack of objectivity’ by the French Medicines Agency.

Mme. Rivasi therefore concluded the press conference with a forceful:

‘Enough is enough!  It is time to demand a moratorium on this vaccine!   EU member states must stop recommending this vaccine until more studies are conducted on Gardasil, its effectiveness and its dangers.’

Michele Rivasi, MEP

Less than two months later, her efforts seemed finally to be having some effect: on the 22nd May, under pressure from victim support groups, primarily E3M, an NGO supporting patients with macrophagic myofasciitis, two colloquia with round-table debates open to the public and in the presence of the press, television and even French Health Minister Marisol Touraine, were organised at the French National Assembly: one in the morning by E3M and facilitated by journalist Viginie Belle, the other in the afternoon by Office parlementaire des choix scientifiques et technologiques (Opecst, similar to our House of Commons Science and Technology Committee).

A fair number of the speakers from the April press conference (Gherardi, Authier, Shoenfeld, Orianne Lochu’s mother, Tomljenovic, Belec, Rivasi) took part, alongside representatives from Sanofi-Pasteur, GSK, the French government and other scientists promoting vaccines.  Pro-caution and pro-choice scientists also included our own Prof. Christopher Exley from Keele University, Dr. Lluis Lujan, veterinary pathologist from the University of Zaragoza in Spain and Prof. Michel Georget, French biologist and author of books on the adverse effects of vaccines.

Topics of the four round-table debates: 1) Aluminium: Adjuvant under Scrutiny. 2) HPV Vaccine: Time to Exercise Caution, in the morning.  Then in the afternoon: 1) The Safety and Efficacy of Aluminium Vaccine Adjuvants.  2.a) Is a Moratorium Appropriate?  2.b) Are there Alternative Vaccine Adjuvants?

For those who speak French, these debates can be viewed here: http://videos.assemblee-nationale.fr/video.5464.  Compared with our House of Commons Science and Technology Committee’s Evidence Check into Homeopathy in 2009, this series of debates seemed far more balanced!  The focus in France seems at present to be only on aluminium, which may not be the only issue but time will tell as to where it takes the whole French and European vaccine debate.

Knowing that the French Health Minister attended these colloquia and is therefore now fully aware of the latest research on the damage caused by aluminium adjuvants and the Gardasil vaccine, it came as a shock when instead of calling for a moratorium she later reaffirmed the French government’s intent to vaccinate all young French women with this vaccine.  Yet another debate was then organised on the 23rd of June by a group of galvanised GPs from La Réunion island, one of France’s overseas departments.  The thrust of this series of medical and statistical presentations, again hosted by Michèle Rivasi, was that HPV vaccination is not needed to prevent cervical cancer, is excessively costly and the whole vaccine development and marketing process is fraught with conflicts of interest.  Gardasil is clearly a hot topic in France with articles, blogs, petitions and debates appearing frequently.  The doctors, researchers, support groups and victims behind these are not about to give up the fight for both a moratorium on Gardasil and aluminium-free vaccines in general.

Remember that in the USA and the UK, HPV and other vaccine victims are fortunate to have SaneVax (http://www.sanevax.org) who in addition to providing the necessary information for making an informed choice, can locate appropriate medical/legal assistance in the event of an adverse event post-vaccination.

Since the April press conference, the EFVV has prepared a Manifesto in English, French, Spanish, Italian, German, Dutch and Slovenian (other languages possibly to follow), demanding the abolition of mandatory vaccination in the EU (see http://www.efvv.eu).  The plan is to launch a petition based on this Manifesto and a delegation of EFVV members will be meeting with Michèle Rivasi in September to discuss the best way to utilise these documents and submit their demands to the European Parliament.  Watch this space, both in France and Europe-wide.

(Note: This article was originally written for Homeopathy in Practice, the journal of the Alliance of Registered Homeopaths in the UK but, with kind permission of HIP, is appearing here first.)

Article compliments of SaneVax.org