Monthly Archives: June 2017

Gardasil was fast-tracked

In 2006 when the HPV vaccine Gardasil was licensed and marketed to young girls and women 9-26 years of age, the phase 3 clinical trials had not been completed. This meant that the benefits of the vaccine and any safety issues arising from it were not known. The time period from clinical trial to recommending the vaccine was only 4 years. According to Dr Diane Harper, one of  Merck’s HPV researchers “most vaccines take 3 years to develop and then 5 to 10 more for universal acceptance.” “Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now.”

Gardasil was fast-tracked by the US Food and Drug Administration (FDA) due to industry lobbying from the manufacturer Merck who in December 2005 submitted an application to the FDA for fast track approval. Shortly after in February 2006 Merck announced that the FDA had given the go-ahead and that Gardasil was to be given a ‘priority review’. Such an accelerated review is reserved for vaccines and other products that are urgent and for conditions where other treatment does not exist. Did Gardasil fulfill this unmet need? No it did not. Cervical cancer is a rare outcome of HPV infection and in countries with cervical cancer screening programs, cases of the disease and fatalities have more than halved and if a cancer is found early and treatment given, the 5 year survival rate is 72%. But in spite of these facts the FDA review date was scheduled for June 8 , 2006 whereupon the first HPV vaccine was approved and recommended for all women aged between 9-26 years even though it had not been tested for the prevention of precursor lesions in females younger than 15 years of age.

In Too Fast or Not Too Fast: The FDA’s Approval of Merck’s HPV Vaccine Gardasil, Canadian researchers Lucija Tomljenovic and Christopher A. Shaw state that ‘Merck’s HPV vaccine Gardasil failed (and continues to fail) to meet a single one of the four criteria required by the FDA for Fast Track approval’.
According to Tomljenovic and Shaw,
In order to gain approval, a Fast Track drug must demonstrate the following:
1. Show superior effectiveness to existing treatments (if such are available)
2. Avoid serious side effects of an available treatment
3. Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
4. Decrease a clinically significant toxicity of an accepted treatment
Even so Gardasil continues to be marketed and promoted to young girls and now boys for prevention against a disease they are most unlikely to ever get.
Read more about how this Fast-Tracked and Flawed vaccine was licensed and marketed in Gardasil: Fast-Tracked and Flawed

 

 

 

 

Advertisements

1 Comment

Filed under Uncategorized

Can we talk about this?

Current thinking is that the human papilloma virus (HPV) causes cervical cancer and that all girls and boys in early high school need to be given HPV vaccines. In my book Gardasil: Fast-Tracked and Flawed I trace the early history of cervical cancer from a disease of obscurity to one of mainstream prominence. I have found and documented the numerous theories about the cause(s) of cervical cancer which have come and gone over the decades. I have read and written about how in the early years of the nineteenth century physicians claimed that sex was involved for it was observed that the disease was found in larger numbers among poorer, city women than amongst women in long term and stable relationships and in women who were living in rural areas. It was also thought that the disease was very rare in nuns until further research showed that religious sisters were subject to the disease too, and that, contrary to prevailing opinion, women in long-term relationships also developed cervical cancer. It was suggested that in the case of cancer of the uterus that the trauma of childbirth itself could be a risk factor. Such speculation might explain why there was more cervical cancer among women of low socioeconomic status than among women of means. Poorer women tended to have more children, lived harsher lives and possibly received less medical care, as well as missing out on much-needed rest and recovery time after the birth of their children.

I believe these early researchers were on the right track when they suspected that social circumstances such as poverty and inequality were in some way implicated in the disease process. British psychologist, author and researcher Susan Quilliam documented these lifestyle factors that might increase the chance of becoming ill with cervical cancer in her 1989 book Positive Smear. Written just before the idea that the human papillomavirus might be involved, she stressed the importance of a balanced diet and claimed that deficiencies in vitamin C, beta carotene and folic acid were common in women with cervical precancerous cells. Quilliam strongly emphasised the importance of a healthy environment, good hygiene and excellent nutrition as prerequisites for good health and resistance to disease. When discussing the causes of cervical cancer, she doesn’t shy away from a conversation about the contraceptive pill and how it has a negative effect on natural immunity as well as a propensity to lessen the body’s ability to use folic acid.

Today such environmental and socioeconomic factors relevant to the causation of cervical cancer are rarely considered. Instead the human papilloma virus is said to cause cervical cancer, no questions asked or answered.  Why, when and how this has happened is crucial to the story of Gardasil: Fast-Tracked and Flawed.

 

1 Comment

Filed under books, Free Speech, gardasil, health, history, Media and health, pharmaceuticals

News, book launch and crackdown on free speech

I keep finding more information that I have not included in my book Gardsil: Fast-Tracked and Flawed.

I recently watched an hour – long interview with a New Zealand couple whose daughter had been injured post vaccination with Gardasil. Her mother had said no to the consent form sent home by the school but on the day of vaccination her daughter was bullied into it – made fearful by classmates and those giving the shots that she didn’t have it she would get cervical cancer and so submitted to the vaccine. The next morning she awoke with a blinding headache and from there her health went from bad to worse. It cost this family much in terms of heartache and money to obtain the help they needed to get their daughter well again. The medical system could do nothing – they could not or would not see the connection between the young girl’s condition that consisted of neurological problems and reproductive issues in that her periods had ceased and so the family sought homeopathy and naturopathic treatment. The treatment is expensive– there’s the testing involved, the detoxing and supplementation. This young girl was fortunate in that her parents were able to seek out and provide this treatment. There are so many who aren’t able to afford this and many who remain ignorant of what is wrong with them and that alternative treatment is available. The information is not in the mainstream where it should be.

In Gardasil: Fast-Tracked and Flawed I have written that there are over 50,000 adverse reported events after vaccination and yet during this interview I heard about another larger database of adverse events called Vigibase. It’s a World Health Organisation database and they record the total as over 73000. This of course is still far from accurate as many people don’t know where or how to record their event. It is good that we know where to record these events but what is being done about the huge number of adverse events. Where is the inquiry into these events – surely the World Health Organisation should be insisting on an inquiry and cessation of this vaccination program?

Of this 73,000 adverse events there are some astounding totals

  • Blood and lymphatic system disorders (1718)
  • Cardiac disorders (1921)
  • Congenital, familial and genetic disorders (246)
  • Ear and labyrinth disorders (1356)
  • Endocrine disorders (284)
  • Eye disorders (4076)
  • Gastrointestinal disorders (13313)
  • General disorders and administration site conditions (38918)
  • Hepatobiliary disorders (231)
  • Immune system disorders (1495)
  • Infections and infestations (3935)
  • Injury, poisoning and procedural complications (8507)
  • Investigations (11205)
  • Metabolism and nutrition disorders (1445)
  • Musculoskeletal and connective tissue disorders (12048)
  • Neoplasms benign, malignant and unspecified (incl cysts and polyps) (874)
  • Nervous system disorders (32911)
  • Pregnancy, puerperium and perinatal conditions (1153)
  • Product issues (58)
  • Psychiatric disorders (4080)
  • Renal and urinary disorders (942)
  • Reproductive system and breast disorders (2663)
  • Respiratory, thoracic and mediastinal disorders (4852)
  • Skin and subcutaneous tissue disorders (12557)
  • Social circumstances (1342)
  • Surgical and medical procedures (1737)
  • Vascular disorders (4714)

In Australia 12-13 year old girls and boys are vaccinated with Gardasil as part of the school vaccination programs: Figures from 2014–15 reveal that nationally nearly 79% of girls aged 15 were fully immunised against HPV and 67% of boys. The uptake of Gardasil is much lower in the US where figures recorded for 2013 show that around 40% of girls and 35% of boys have received three doses. No surprise then that there is talk of mandatory vaccination with HPV vaccines in parts of the US. In a highly controversial, unprecedented motion, members of the Allegheny County Health Department in Pittsburgh, Pennsylvania, have publicly revealed that they’re considering administering a countywide mandate to require all 7th grade girls and boys to receive the HPV vaccine before receiving admittance into school for the 2017–18 school year. This is very wrong and not only because they want to forcibly administer this vaccine but the HPV vaccine has been linked to more cases of death, disability and other serious side effects than can be traced to any other vaccine. And as noted in the book HPV vaccines are being associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause.” Surely there are enough problems with infertility already but no we’ll just cause a bit more – this time to teenagers – the future parents.

We need to spread the word about HPV vaccination before they mandate this one in Australia as they have done with the childhood shots linking them to family payments and entry to childcare. Imagine your teenagers not able to go to high school if they don’t get their HPV shots. HPV is not a communicable disease like measles. There is no need for this vaccine which was said to prevent Cervical Cancer and yet there is zero scientific proof that the vaccine has prevented a single case of Cervical cancer in any country. People are resisting all over the world – but very quiet in this country.

 In July 2016, 63 Japanese women and girls aged between 15 to 22 years sued the government and the drug makers for damages over health problems they suffered after they were vaccinated with the HPV vaccines Cervarix and Gardasil. The plaintiffs who had experienced a range of health problems starting after their HPV vaccines are seeking compensation of at least 15 million yen each. The women insist that the government provide expert medical help for their symptoms and that research for a cure happens. The women’s lawyers have stated: “the causal relationship will be acknowledged because the victims have common symptoms”. In the United States vaccine companies have immunity from prosecution. To understand how this happened, we have to turn the clock back to 1982. That is when four big drug companies (Merck, Wyeth, Lederle, Connaught) threatened to stop selling vaccines in America unless a law was passed giving them complete immunity from prosecution. So claims are submitted to the US national vaccine injury compensation program. The drug companies are not sued.

By March 20, 2013 Judicial Watch the National Vaccine Injury Compensation Program had awarded $5,877,710 to 49 victims for harm resulting from the HPV vaccine and up to 2016 there were a total of 119 cases of damaged litigants compensated. There is no proof that this vaccine can prevent cervical cancer. It may result in more cases for there are reports of young women who have got cervical cancer after the vaccine. There are likely to be more cases of cervical cancer because there are changes to the successful Pap smear programs that are to start in December. Instead of the Pap smear test there is to be an HPV test. This of course predicated on the basis that HPV causes Cervical Cancer but there are many cases of Cervical cancer where the women are found to be HPV negative. So these cases of early cervical cancer may be missed.

At the launch of my book Gardasil: Fast-Tracked and Flawed my publishers and I were verbally attacked by two ardent pro-vaccinators one of whom was a virologist and the other an immunisation nurse. As well as being very disruptive and insulting they were dismissive of a woman in the audience who related the story of her two good friends who had suffered adverse effects from the Gardasil vaccine. The incident was surprising and begs many questions: Why were these two people there? What did they hope to achieve by their interruption and their attempts at disputing the facts presented in the book. Do they hope to shut this story down. Am I to be intimidated into silence?

Such ardent promoters of vaccination must be very worried that the  public is becoming aware that vaccines carry real risks. It is no surprise to read that Australian nurses and midwives who dare to speak out against the dangers of vaccinations on social media or in person will be prosecuted and that the Australian government is urging members of the public to report vaccine skeptics to the authorities.We are entering dangerous times when we cannot speak openly about medical procedures such as the Gardasil vaccination that can cause harm to some people.

 

 

 

 

Leave a comment

Filed under books, gardasil, health, human rights, pharmaceuticals, politics, vaccination

Gardasil Girls

Laura is one of the Irish ‘Gardasil Girls’. She was a normal active teenager and an“asset in the classroom,” said her mother. After her first Gardasil shot, Laura became unwell and required her mother to pick her up from school. When she complained of dizziness, headache and nausea, she was told this was normal. Her condition worsened after her second vaccination to such an extent that she soon was unable to attend school. According to her doctors, she was suffering chronic fatigue syndrome but whatever the experts chose to call these debilitating conditions, the girls and their families are united in their conviction that they became ill after their HPV vaccinations ( TV3 Ireland, 2016, in Lobato 2017)

According to an article written in Trinity News, the rate of HPV vaccination in Irish schools has dropped by 10% over the past year. When you read that there is believed to be more than 800 cases of adverse events suffered by Irish girls following the Gardasil vaccination it is a wonder that the rates  haven’t fallen further. The author of Numbers of Irish students opting for the HPV Vaccine drops considerably Caoimhe Gordon sets out to explore why this is happening. Gordon quotes Professor Kingston Mills of the Experimental Immunology department at Trinity who points the finger at the internet and social media and urges “parents to focus on the scientific evidence and not “hearsay” that can be found online.” The news that the rate of immunisation in Ireland has tumbled to 70% has experts concerned that the “universal acceptance of the vaccine” in no longer guaranteed. Gordon blames the anti-vaccination campaigns which are run by the group REGRET (Reactions and Effects of Gardasil Resulting in Trauma) which is made up of parents of the Irish girls who have become ill. Their daughters are sick and many struggle to get out of bed and complain of headaches and joint pain and extreme tiredness.

Around 300 Irish women are diagnosed with cervical cancer annually and the death toll is around 90 so it is safe to say there is no cervical cancer epidemic in Ireland. But now we have huge numbers – around 800 young girls who from all accounts were active and healthy before they had their Gardasil shots and are now very ill. The parents are fighting hard to get help for their daughters. Like so many other sick girls and now boys around the world they are not receiving effective medical treatment. They are often not able to go to school due to their devastating health conditions.

Irish philanthropist Jonathan Irwin has joined the struggle to achieve justice for Gardasil Girls. Irwin who is the founder of Jack & Jill charity for sick children, explains how the Gardasil HPV vaccine has injured his daughter Molly who remains ill. Irwin regards the vaccine as a “disaster” and “useless.”He has stepped down from his position as CEO to care for his daughter who is bedridden, following what he says was a severe reaction to the Gardasil vaccine. He says this vaccine should never have been included in the national program. One solicitor he knows has 75 cases which will be taken to the courts. Irwin doesn’t rule out using the courts himself in an attempt to get justice for his daughter and the other ‘Gardasil Girls’. “My teenage girl has lost her teenage life,” says Irwin.  Irwin also wants a review of the vaccine. He insists that if he had known about the side effects he wouldn’t have allowed his daughter to be given Gardasil. He urges parents to read the vaccine leaflet which lists the side effects in black and white. The fact that the severe side effects of this vaccine are listed on the prescriber information found on the manufacturer Merck’s website is an important point because it means that the makers of this vaccine knew the real problems with this vaccine but went ahead and marketed this so-called cervical cancer vaccine. This is outrageous!

Jeffrey Jaxen is a researcher and journalist who says that the interesting thing about the case of the girls who have been damaged after Gardasil, is that unlike babies who can’t speak and say that they were feeling great before they had a vaccine, the Gardasil Girls can speak and are doing so. He says that each culture is handling this disaster differently and a lot of how they do this has to do with how they handled revolt in the past – “the memory of each culture’s revolting spirit”. He gives the example of the Irish mothers who are “fiery” and about whom he says “are kicking some major butt.” In Ireland these activist mothers have got the issue on the mainstream and are keeping it there (The Truth about Vaccines, 2017).

I am pleased that there are now many people who are waking up to the huge error that is this vaccine, one that has not been shown to prevent a single case of cervical cancer. I have spoken to many young women about how they have been damaged after Gardasil, just another one yesterday told me about how the vaccine nearly killed her. She had spent too many years and far too much money on finding a cure for her vaccine injury. I have also met and spoken to a young passionate man whose New Zealand cousin died after receiving Gardasil. His activism had become even stronger for his sister was now having severe menstrual problems after her course of the HPV vaccine.

Paediatrician and author Dr Paul Thomas calls Gardasil his least favourite vaccine. One reason is because the placebo that was used was aluminium when a placebo should be an inert normal saline solution. By using aluminium as a placebo the vaccine appears less dangerous. He states that the research into the vaccine was stopped early and the vaccine fast-tracked after researchers found some decrease in the cases of cervical dysplasia. His assessment of the new Gardasil 9 was even more telling. “There will be more deaths from that vaccine than there ever will be cases of cervical cancer ” (The Truth About Vaccines, 2017).

Cervical cancer is not a communicable disease. There is no need for this vaccine. Cases of cervical cancer have declined especially in western nations where living conditions are good and Pap smear testing is encouraged. As to our next move Jeffrey Jaxen says encouragingly that he is witnessing ‘Medical Disobedience’ in regard to the mandating of vaccines. He says that he has spoken to doctors who have told him that in their rooms they have more oranges with vaccines in them than have the children.  This is so encouraging. May the revolution continue.

References:
Gordon Caoimhe (2017) ‘Numbers of Irish students opting for the HPV Vaccine drops considerably’. Trinity News. http://trinitynews.ie/numbers-of-irish-students-opting-for-the-hpv-vaccine-drops-considerably/
Lobato, Helen (2017) Gardasil: Fast-Tracked and Flawed. Melbourne. Spinifex Press. http://www.spinifexpress.com.au/Bookstore/book/id=294/
TV3 Ireland (2016) ‘Gardasil Girls in Ireland’. The Vaccine Reaction. January 10; http://www.thevaccinereaction.org/2016/01/gardasil-girls-in-irelandtv3-hpv-documentary/
The Truth about Vaccines. (2017) https://go2.thetruthaboutvaccines.com/docuseries/order/
The Thinking Mom’s Revolution (2017) Irish Philanthropist Jonathan Irwin Vows to Stand Up For Gardasil-Injured Girls. http://thinkingmomsrevolution..com/irish-philanthropist-jonathan-irwin-vows-stand-gardasil-injured-girls/

 

Leave a comment

Filed under health, Media and health, news, politics, Uncategorized