Sanevax: Why Is A Highly Sensitive HPV Test Used In Vaccine Development And Not For Patient Care?By Norma Erickson, President The SaneVax Team wants to know why consultants paid by the pharmaceutical industry appear to be using the World Health Organization (WHO) and the National Cancer Institute (NCI) to promote a double standard of HPV testing to market “cervical cancer vaccines” at the expense of women’s health. Are HPV vaccine manufacturers, the NCI and WHO afraid of what a sensitive and accurate HPV test would disclose if one were used for post-vaccination monitoring and patient care? According to a recent article in Cancer Medicine,[i] a group of researchers from Shanghai reported that the commonly used Digene (Qiagen) HPV HC2 test kit promoted by the NCI identified only 57.6% of the 624 infections by a single high-risk human papillomavirus (HPV). Is it coincidence that the NCI is one of the inventors of the “cancer vaccine” Gardasil®? Is a 57.6% success rate good enough for your family’s healthcare? The authors also introduced a novel approach to identify various combinations of multiple HPV infections, demonstrating that up to 5 HPV genotypes in one single sample could be validated by direct DNA sequencing. The team, headed by Professor G.F. Hong, emphasized the importance of using a highly sensitive and specific method if HPV testing is to be used as the primary cervical screening followed by Papanicolaou cytology for cervical cancer detection. The authors stated: “As in many developing countries, China needs a financially sustainable and reliable screening system to reduce the cervical cancer mortality rate. How to integrate such an analytically reliable molecular test into a system supplemented by cytopathology-based cervical screen for cervical cancer prevention must be determined by medical and scientific professionals with primary concern about improvement of women’s health care under various resource settings rather than by (the) business agenda of the industry.” In stark contrast, Dr. Joakim Dillner, head of the WHO vaccine team and a paid consultant of Merck/SPMSD (a manufacturer of HPV vaccines), openly promoted a double standard of HPV testing, one for vaccine development and one for patient care when making this statement: “In vaccinology, a high analytical sensitivity is needed as failure to detect prevalent infections at trial entry may result in false vaccine failures in vaccination trials. It should be noted that HPV tests used in cervical cancer screening programs have different requirements for evaluation, since for that purpose only HPV infections associated with high-grade cervical intraepithelial neoplasia or cancer are relevant and not the transient infections that do not give rise to clinically meaningful disease. Since the latter are characterized by low viral loads, HPV screening assays do not have as high demands on analytical sensitivity.”[1] Informed medical consumers would like to ask the WHO vaccine team: 1. If a test with high analytical sensitivity was used during clinical trials only, would the less sensitive tests used for post-vaccination surveillance and patient care generate a set of false negative results which might artificially raise the efficacy rating of the vaccine by only identifying 57.6% of HPV infections? 2. If only the less sensitive HPV test results are useful in evaluating clinically meaningful disease, would the analytically sensitive HPV test used upon clinical trial entry prove the vaccines only were effective in preventing diseases that are not clinically meaningful? “SiHa cells has about 1 copy of HPV 16 per cell…”2 The fact is that SiHa cells is a culture cell line of human cervical cancer. So the authors knew that human cervical cancers may contain as little as one copy of HPV virion per single cancer cell when they made the statement: “HPV screening assays do not have as high demands on analytical sensitivity” This group of HPV vaccine promoters seems to be using the name of the World Health Organization to mislead the public into accepting an inaccurate HPV test for patient care while creating a double standard to obscure the facts relating to the evaluation of HPV vaccine efficacy, not to mention HPV vaccine safety. This same WHO publication stated: “Accurate and internationally comparable HPV DNA detection and genotyping methodology is an essential component both in the evaluation of HPV vaccines and in the effective implementation and monitoring of HPV vaccination programs. Genotyping assays used today differ in their analytical performance with regard to type-specific sensitivity and specificity.” In other words, the vaccine team knew that the NCI and the Gardasil® manufacturer did not use an FDA-approved HPV test, or an accurate internationally comparable HPV DNA detection and genotyping methodology for evaluation of the vaccine’s efficacy during the clinical trials because there is none. If there is still no satisfactory HPV DNA detection and genotyping method, how are medical consumers supposed to trust clinical trial results which were evaluated using tests methods arbitrarily selected by the vaccine developer prior to 2006? In yet another Guidelines article, the same Dr. Joakim Dillner, along with Dr. C.J.L.M. Meijer and several other industry paid consultants attempted to justify using less sensitive HPV tests for patient management by stating: “the U.S. Food and Drug Administration-approved Hybrid Capture 2 (hc2; Qiagen, Gaithersburg, MD, USA) and GP5+/6+-PCR enzyme immunoassay (GP5+/6+-PCR EIA) have repeatedly demonstrated clinical sensitivity of about 90.95% for the detection of CIN 2 in large prospective cohorts or randomized controlled trials.”[ii] Any woman with a rudimentary knowledge of cervical cancer screening knows a “90.95% rate for the detection of CIN 2 lesions” may be a test to openly invite medical malpractice; let alone the fact that CIN 2 is well-known as being a self-reversing entity. How could Dr. Meijer, a professor of pathology and leading author of the paper, have endorsed such a recommendation? It turns out Dr. Meijer is a major stockholder of Digene Corporation as published in Digene Corp. 10-K For 6/30/98 EX-10.37.[iii] Digene Corporation was sold to Qiagen, a Dutch company, for $1.6 billion in 2007. To sum it all up, a scientific research team in Shanghai is working diligently to find a science-based sensitive and reliable HPV test for cervical screening to reduce cervical cancer mortality in China. Meanwhile, it appears vaccine inventors and industry-paid consultants are using the offices of the WHO and the NCI to promote a double standard to justify prevention of clinically insignificant HPV infections with a ‘cancer vaccine’ along with a not too sensitive HPV DNA test for post-vaccination surveillance and patient management at the expense of women’s health. Are these people afraid an accurate and reliable HPV test would show medical consumers their miracle vaccine is not such a miracle after all? If so, informed medical consumers will hold those who knowingly wrote inappropriate medical practice guidelines accountable for the harm their ‘expert opinions’ cause. My Personal Gardasil Journey By Kristin Clulow Hello from Newcastle, NSW, Australia. My name is Kristin Clulow. I am currently 29 years old, and I am a Gardasil survivor. If someone had told me four years ago that my life would be where it is now, there is no way I would have believed it. Simply put, I am blessed. Before Gardasil, I was fit and healthy. I had a Business degree, had a great job, great friends, and a great life. I didn’t drink, smoke or do anything to harm my body. I was 55kg. I loved sports and being outdoors. I had so much in my favour. In May 2008, I received my first of three injections of the highly publicised, Government sponsored Human Papillomavirus (HPV) vaccine, commonly known as Gardasil. It is a mass produced vaccine, promoted and encouraged for females ages 9-26 years, for the prevention of cervical cancer. I was administered this by my General Practitioner (GP), who explained the benefits, but no risks to my health. Two weeks after receiving the first of three vaccines, I fell at Karate and broke my left foot. It was a bit strange, as I have always been a bit of a tom-boy, and have suffered little injury. I was in a moonboot and on crutches for six weeks. This coincided with starting a new job (which was a little awkward), but I coped well. In August 2008, I received the second vaccine. I had just come off crutches and was regaining the strength in my left leg. Approximately 4-6 weeks later, different things began to happen. One weekend in September, I lost my sight. This then came back. Soon after, I couldn’t stand in heels. My balance had started to go. I then could not dance, jump, skip or run. I couldn’t wear open backed shoes. My walking started going ‘wonky’ and my balance and co-ordination wasn’t what it was. My handwriting then disappeared. My body would start twitching and shaking when I had intent to do something. I could feel my speech beginning to be altered. All of this happened primarily to my right hand side. It was like I had a stroke. Several visits to the same GP who had administered the vaccine proved ineffective – I was told it was everything from stress, a pinched nerve, to insanity. Needless to say, I changed GP’s in the hope of an answer. I switched to a new GP who had not witnessed this sudden deterioration before, but knew there was something wrong. He sent me to a Neurologist for further assistance. After several tests, I was diagnosed as having Multiple Sclerosis (MS). Although there were no signs on any scans or tests, all bodily signs presented pointed to this. I was administered three doses of IV Methylprednisolone treatment over three days. This saw little improvement. In December 2008, I resigned from my job as my health continued to deteriorate, and went full time in the retail environment. In January 2009, I sought a second opinion from a Neurologist in Sydney. After examining my presented physical symptoms, he asked me one question: ‘Have you had any vaccines recently?’ He explained that he had several patients recently presented to him with similar symptoms. Every patient had one element in common: Gardasil. He recommended that I undertake five days of IV Methylprednisolone treatment. Although this had done little before, at this stage my health was deteriorating, and I thought it may help. It didn’t. IV Methylprednisolone is a steroid. My Neuro explained it simply. He said it is like a ‘fire’. It goes through your body and kills off everything, and then your body can rebuild. The problem was, my body had been knocked down so much, it couldn’t get back up. The next five months saw my health deteriorate further. I had blackouts, hallucinations, and struggled to do simple, everyday tasks. I couldn’t sleep. I was constantly sick. I worked full time, attended physiotherapy, occupational therapy and speech therapy. When my symptoms extended to encompass my left side, my medical team went back to the drawing board. I underwent a PET scan in June 2009. The process is similar to an MRI scan, but the results are more detailed. The results of this scan showed that my cerebellum – the part of the brain the controls the motor functions had switched off. This warranted IV Immunoglobulin (IVIG) treatment. By June 2009, I struggled with everything that I had taken for granted before. I struggled to walk. I had to hold onto things to keep my balance. I couldn’t walk in a straight line. I couldn’t walk down a corridor without being puffed. I remember being wheeled to a scan in a wheelchair. For a previously healthy, active and always on the go person, this was absolutely devastating. Even now, remembering this brings tears to my eyes. I struggled to speak. I could say a few words, but stringing a sentence together was impossible. It was so frustrating because I knew what I wanted to say, I just couldn’t physically say it. I could not write at all. My hands shook so much that even holding a pen and not throwing it across the room was impossible. I struggled to eat. I remember my Mum feeding me toast in hospital one morning because I could not get the food to my mouth without shaking, and I could not find my mouth, because my perception of where my mouth was had gone. I had no immune system. The hospital staff believed I may have contracted Swine Flu because I was so sick. I had no nervous system. It was explained to me that the myelin sheath – which acts like a coating around the nerves – had been dissolved. My white blood cells were confused and were attacking themselves. Basically, I was dying. The Neuro was honest with me and told me that the IVIG may work. Or it may not. At this very point, I had two options: sink, or swim. Sinking wasn’t an option. So long as I had breath in me, I would swim. And swim I did. For the next 12 months, I was in hospital every 28 days to receive IVIG treatment. A great deal of this was sponsored by the Australian Red Cross, who I am forever grateful to. IVIG is the ‘peacekeeper’. It is human auto-immune and helps to restore the body. The thing is it can only do so much. The rest is up to you. I underwent intense physiotherapy, occupational therapy, speech therapy and hydrotherapy. I was told I could not work for at least two years. It was believed to have been an illness called Acute Disseminated Encephalomyelitis (ADEM). ADEM is defined as ‘an immune mediated disease of the brain. It usually occurs following a viral infection but may appear following vaccination, bacterial or parasitic infection, or even appear spontaneously. As it involves autoimmune demyelination, it is similar to multiple sclerosis, and is considered part of the Multiple sclerosis borderline diseases. Simply put, it presents itself in a similar physical manifestation to MS; however it is believed that the ADEM which I experienced was a one off attack of my immune system, not ongoing degeneration. Also, unlike MS, the myelin sheath is believed to be repairing. In December 2009, I enrolled to undertake a Masters of Teaching (Secondary) at the University of Newcastle. Looking back, I am sure everyone thought I was insane, considering I could barely walk, write or speak. For me, teaching was one of those things that I had always thought of, but had never done, and as I had two years off work, I thought it was the best time to do it. Plus, it would keep my mind busy. I was accepted, and commenced full-time study in February 2010. The two years that followed were full of Physio, Rehab, Gym, Study, Medical appointments and much, much more. I filled up my days as much as I could and pushed myself as far as I could. And the results spoke for themselves. In November 2011, a repeated PET scan showed that my cerebellum was coming back to life. This was a miracle. When the cerebellum switches off, it dies and shrinks. Mine didn’t. I am now a high school teacher. I absolutely love my job, and my students are amazing. I have the most awesome family and friends, and an amazing God who is always on my side. Without them, I wouldn’t be who, or where I am right now. I am so blessed to be in a position where I can help other girls and families who are going through a similar situation. This experience has changed who I am without a doubt. It has made me appreciate all of the wonderful things in life, and not to worry about the things that don’t matter. It has taught me to be happy, and always look at things positively and to always laugh and to always have fun. I won’t lie, it has been the hardest time of my life, but it has been the most rewarding. I have been subjected to a great deal of physical pain, and still live with the pain each day. I push my body each day, which is both painful and frustrating. The accusations and remarks that I have dealt with from people who do not understand the situation only cause me to have a thicker skin, and a greater empathy for those who live with an incurable illness. The mental and emotional turmoil is surreal, and is made a thousand times worse by the drugs causing havoc within the body, and the overall uncertainty of the situation. I quickly learnt that having a positive attitude and living each day to the fullest was the best way to go. I may never be 100% again, but I’m cool with that. It just gives me something to keep working toward. To all the girls struggling with this, I have been there. Never give up. Don’t let this beat you. You don’t know how strong you are until you have to be. Every day is a blessing. Have a little faith. There is a great deal of information that I have not had time to mention here. If you would like more information, advice, or to be put in contact with others that can help, please contact me via the SaneVax team at victims@sanevax.org or via Face book (Kristin Clulow). |
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