Tuesday, July 10, 2012
SaneVax: Why is a highly sensitive HPV test used in vaccine development and not for patient care?
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 Medicine1, 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."2 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? The truth is partially revealed in another statement within the WHO team's report when they wrote: "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 GardasilR 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."3 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.4 10-K For 6/30/98 EX-10.37. 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. Written by Norma Erickson, President of SANEVAX, INC. http://sanevax.org/ http://onlinelibrary.wiley.com/doi/10.1002/cam4.9/full http://www.ncbi.nlm.nih.gov http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2789446/?tool=pubmed http://www.secinfo.com/dsvRq.73a6.d.htm. Source - www.naturalnews.com
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