| Are FDA Practices Killing You? And Can We Trust The FDA At All? (In This Age Of Fundamental Distrust Of, And Disillusionment With Government And Governmental Agencies; These Are Fair Questions To Be Asking.) (Trust And Respect Are Earned And Lost With Experience And Events. In My Case, The FDA Has Lost Both. Ed.)  (SaneVax: Apparently the FDA has little, if any, interest in real science, particularly when it comes to vaccine safety. The following interview probably reveals only the tip of the iceberg when exposing problems with Gardasil that are ignored by the FDA. Since the FDA is supposed to be responsible for ensuring the health and safety of the population of the United States--and other countries who rely upon FDA for medical science--those within the organization should be held personally accountable for their failures to act in the public's best interest.) This shocking interview with Norma Erickson, President of SaneVax Inc., conducted by Catherine J. Frompovich, reveals one of a host of apparent reasons the medical system in the United States has become the number one cause of iatrogenic illnesses and death, as reported in peer review journals.]) Sin Hang Lee, MD, is a medical practitioner historically qualified to practice medicine in the People’s Republic of China, the District of Columbia, New York State, and the State of Connecticut in the USA, plus in Canada and British Commonwealth countries via his registration with the General Medical Council of the UK. Currently Dr. Lee holds a medical license in the State of Connecticut, USA. Dr. Lee has staff privileges at the Milford Hospital in Milford, Connecticut. He was certified by the American Board of Pathology in anatomical pathology (1966); certified in general pathology by the Royal College of Physicians and Surgeons of Canada (1966); and granted the F.R.C.P. degree by the Royal College of Physicians and Surgeons of Canada (1966). Dr. Lee has practiced diagnostic pathology in Canada and the USA continuously since 1966 with a special interest in developing new technologies in laboratory medicine. His most recent research is the use of low temperature (LoTemp®) polymerase chain reaction (PCR) and direct automated Sanger DNA sequencing to increase the sensitivity and specificity of the molecular diagnosis of infectious diseases. Using Dr. Lee’s new methods, PCR can detect HPV L1 gene DNA bound to nanoparticles; it can detect HPV L1 gene DNA of vaccine origin present in human blood and tissue samples. Norma, given the above professional bio about Dr. Lee, one has to assume he is more than qualified to discuss his findings with regard to the Jasmine Renata case in New Zealand. I understand Dr. Lee was one of numerous experts and witnesses to testify at the recent (August 9, 2012) two-day inquest held to determine the cause of death, which could not be determined officially by autopsy. This case has gathered local interest and coverage. I understand the New Zealand press covered the event in real-time and reported on it. Here are two links to that coverage. The Dominion Post Ostago Daily Times Since we cannot discuss the inquest until the coroner releases that information, let’s talk about some of what we know. Dr. Lee tested 16 samples of Gardasil® in use from 9 countries, each with a different lot number. The lot numbers of the 5 New Zealand samples, the cities of origin and the HPV genotypes of the L1 gene DNA found in each sample are listed below: Lot # Country/Source Results NL01490 New Zealand, Tauranga HPV-18HPV-16 NK16180 New Zealand, Northland HPV-18HPV-16 NK00140 New Zealand, Tauranga HPV-11HPV-18HPV-16 NM08120 New Zealand, Christchurch HPV-11HPV-18HPV-16 NL13560 New Zealand, Wellington HPV-11HPV-18HPV-16 There seems to be a potential problem that falls back on to the Renata case insofar as Dr. Lee’s findings in Jasmine’s blood and spleen tissue and the above findings. Can you please tell us about that? Yes, Catherine, there are multiple potential problems with discovering HPV-16 L1 DNA in Jasmine’s samples. We must emphasize that what was discovered in the Gardasil® vaccine and in Jasmine’s samples are viral DNA fragments, not the infective wild viruses. First, HPV infection is confined to epithelium. This virus does not survive in the blood or in other organs of a healthy woman. Any naked HPV DNA fragments in the circulating blood would be degraded by serum or intracellular DNA nucleases (enzymes) if these fragments are taken up by the macrophages (a component of the white blood cells), and eliminated from the body in 24-48 hours. Since the HPV-16 L1 gene DNA fragments were discovered 6 months after Jasmine’s last Gardasil® vaccination, we have to assume these HPV DNA fragments were either protected by being firmly bound to the aluminum adjuvant, or by integrating themselves into the human genome through poorly understood mechanisms. Didn’t Jasmine’s mother contact Dr. Lee after she had read that the U.S. FDA announced that the Gardasil® vaccine contained residues of HPV L1 gene DNA? Jasmine’s parents made contact with us after the discovery of genetically engineered HPV DNA in Gardasil® through an associate we work with in New Zealand. They were then put in direct contact with Dr. Lee because of his expertise. I think our readers ought to know that the FDA affirmed Gardasil® samples do contain HPV L1 gene DNA fragments. That can be confirmed on FDA’s website: Wasn’t that an ‘after-the-fact’ FDA announcement to its certifying that Gardasil® was safe and effective, despite it being bound to insoluble adjuvant AAHS particles? How could that have slipped by the certifying process? I guess that does not appear on the vaccine package insert, does it? The webpage you refer to was a public response to the SaneVax letter which informed the FDA of the contaminants Dr. Lee had discovered. Anyone reading the FDA’s announcement should note there are absolutely no scientific references to back up the claims, and I quote, “The presence of these DNA fragments is expected, is not a risk to vaccine recipients, and is not a safety factor.” In stark contrast, readers can examine our original letter informing the FDA of this potential health risk here: Instead of conducting further investigation into our discoveries, including the finding of HPV DNA fragments firmly bound to the insoluble AAHS adjuvant, the FDA issued a blanket statement as to the vaccine’s safety. AAHS is listed as an adjuvant on the package insert. But a molecular complex of HPV DNA or plasmid DNA fragments firmly bound to the AAHS particles (probably through a chemical reaction) are not. Don’t those insoluble adjuvant AAHS [amorphous aluminum hydroxyphosphate sulfate] particles and the HPV L1 gene DNA encourage cytokine production, which apparently is not listed on the vaccine package insert? AAHS is Merck’s proprietary mineral-based insoluble adjuvant with a very high binding capacity for HPV VLPs, the active major capsid protein antigen in Gardasil®. The vaccine manufacturer and the FDA might have known there would be residual HPV DNA and plasmid DNA in the Gardasil® vaccine, if there is evidence to support that claim. However, they did not know (or, if they knew, did not disclose) the physical condition of these naked viral (HPV) and bacterial (plasmid) DNA in Gardasil®. For example, these DNA fragments could be in the aqueous phase (dissolved in water), encapsulated in the VLPs, or bound to the AAHS by electrostatic attraction or an irreversible chemical reaction between the aluminum in the AAHS and the phosphate backbone of the DNA molecules. In his testimony, Dr. Lee presented experimental evidence to show that DNA/AAHS complexes may constitute a new chemical compound with unknown effects. As all AAHS nanoparticles are designed to be phagocytized by tissue macrophages after intramuscular injection, any foreign viral and/or plasmid DNA present would be carried into the cytoplasm of the macrophages along with the AAHS nanoparticles. Once in the cytoplasm, these foreign DNA fragments, protected from degradation, may act as long-acting stimulators to activate the macrophages to signal the production of cytokines, such as tumor necrosis factor (TNF). TNF is a known myocardial depressant capable of causing hypotension and lethal shock in animals and in humans, as well as other symptoms commonly reported by the girls vaccinated with Gardasil®. Persistence of foreign DNA fragments in the cells increases the chance of integration of the foreign DNA into the human genome through poorly understood mechanisms, thus increasing the risk of gene mutations and cancer. Should MDs who administer Gardasil® be aware of that key omission on package inserts because of the potentialities of what can happen to vaccinees, e.g., tumor necrosis factor, even sudden death syndrome from myocardial dysfunction or as a result of maldistribution of peripheral blood flow? It is not standard practice to warn physicians or medical consumers of unproven scientific theories. To date, there has been no research in the area of the risks of foreign DNA being attached to aluminum particles included in vaccines. The research to discover the real risks just has not been done. That being said, those who administer Gardasil® should be made aware of the fact that severe adverse reactions occur at a higher rate than deaths from cervical cancer in most developed countries, the United States being one. [Reference What is the tumor necrosis factor? TNF is a cytokine primarily secreted by macrophages (white blood cells). This cytokine is involved in the regulation of a wide spectrum of biological processes including cell proliferation, differentiation, apoptosis, lipid metabolism, and coagulation. It is one of the cytokines that have been implicated in a variety of diseases, including autoimmune disorders/diseases, insulin resistance, and cancer. [Reference: http://www.ncbi.nlm.nih.gov/gene/7124 ] Isn’t the tumor necrosis factor (TNF) a recognized myocardial depressant? Isn’t TNF known to cause the release of cytokines? TNF is one of the cytokines, which may be produced when either naked viral or bacterial DNA activates the macrophages. Yes, according to Dr. Lee, “It is a known myocardial depressant capable of inducing lethal shock in animals and in humans.” [References: Parrillo JE, etal. J Clin Invest. 1985;76:1539-1553; Kumar A, etal. Am J Physiol Regul Interg Comp Physiol. 2007;292-:R1900-6; Cauweis A, etal. Immunity. 2000;13:223-231; Cauweis A, etal. Arch Biochem Biophys. 2007;462:132-139; Cauweis A, etal. Nat Immunol. 2003;4:387-393.] One may also consider since the medical profession currently uses TNF-blockers to treat inflammatory conditions such as Crohn’s disease, lupus and rheumatoid arthritis, that overproduction of TNF may be a precursor to these and possibly other autoimmune disorders. [References: http://www.medterms.com/script/main/art.asp?articlekey=25458 , If I’m not mistaken, don’t HPV L1 gene DNA residues left in Gardasil® bind to cationic AAHS[amorphous aluminum hydroxyphosphate sulfate] nanoparticles? Yes, at pH 6.0-6.5, AAHS in the Gardasil® vaccine carries a positive charge and the DNA a negative charge. Therefore, there is an electrostatic attraction between the two. But as Dr. Lee testified at the Jasmine inquest, a highly stable, perhaps irreversible, new chemical compound of the cationic aluminum bound to the phosphate backbone of the DNA molecule may have been created in the Gardasil® vaccine. The toxicity of the DNA/AAHS complexes is totally unknown. How much AAHS adjuvant is there in each Gardasil® 0.5ml dose? There are 225 mcg of AAHS in each of the three recommended doses to complete the series. Aren’t the proteins used as antigens in Gardasil® manufactured in yeast cells using genetic engineering? That’s not in the public knowledge, is it—especially genetic engineering manufacturing in association with the use of aluminum-based nanoparticles as adjuvant? What type of impact, if any, would that have in cytokine production? Yes, the HPV L1 protein virus-like particles (VLPs) used as antigens in Gardasil® are manufactured with yeast cultures using genetic engineering. The method by which they were produced was explained, but in my opinion, the general public did not connect the explanation of the concept with genetic engineering. It is my understanding that any foreign (meaning non-human) DNA remaining in the vaccine, whether it be from HPV, bacteria, yeast, or any other ingredient used in the manufacturing process could pose unknown health risks. Viral DNA and bacterial DNA fragments firmly bound to aluminum salts are more of a concern than yeast DNA, particularly when it comes to the potential of causing lethal shock. For those who doubt the HPV L1 gene DNA findings, what are the odds that prove that Jasmine’s samples were accurate and beyond a reasonable doubt? As Dr. Lee testified, his findings are validated by DNA sequencing, the gold standard for HPV DNA detection and genotyping. A few split samples, which Dr. Lee has tested in Connecticut, are being retained in Auckland Hospital. Other interested scientists may reproduce Dr. Lee’s test results by testing those retained samples, which can leave New Zealand only with the Coroner’s authorization. Macrophages—white blood cells—get involved. Can you explain what transpires in the body that implicates Gardasil®? Honestly, I cannot explain what happens in the body. What we have here is HPV L-1 gene DNA in the vaccine firmly attached to the aluminum adjuvant, a DNA/mineral complex, which was not expected. We have HPV-16 L-1 gene DNA in the macrophages of post-mortem blood and spleen samples, a finding which was not expected in a healthy woman. There are only two ways HPV DNA could have remained in post-mortem tissue – either it was protected from normal degradation by being firmly bound to the cationic aluminum; or it had integrated into the human genome. Either One Poses Serious Potential Consequences That Need To Be Defined And Disclosed. It is the job of the FDA/CDC/NCI and any other federal agency responsible for protecting the health and welfare of the American public to conduct the necessary studies to answer the questions about potential health risks. If your readers would like to learn about the potential consequences, I would suggest they search for ‘macrophage activation syndrome.’ They will find over 365,000 sites linking to the latest scientific data. If all Gardasil® samples Dr. Lee tested were positive, what are the implications regarding genetic engineering in any vaccine manufacturing? I would personally think it would bring any genetically engineered vaccine under scrutiny for the same potential risks. That information about Gardasil® impacting white blood cells and tumor necrosis factor does not appear on the vaccine package insert. What do you have to say about that? It would not appear on the package insert, as it was just recently discovered. However, that does not absolve the FDA of at least some culpability in the matter. When the FDA was informed of the contaminating HPV DNA, they did an immediate about-face from ‘no viral DNA’ to ‘it was known and expected.’ If indeed, it was ‘known and expected,’ medical consumers deserve the answers to the following: Exactly when did Merck inform the FDA there is viral DNA in Gardasil®? In a letter dated April 19, 2006, Merck emphatically stated Gardasil® ‘contains no viral DNA. If Merck did report this to the FDA, what did the report state about the physical condition of the HPV DNA fragments in the final product? Were they in the aqueous phase of the vaccine suspension? Were they encapsulated in the VLP’s? Were they bound to AAHS nanoparticles? If so, how were they bound? (Naked foreign DNA in different physical conditions may have different pathophysiologic impacts on the human body.) Did Merck report the presence of plasmid DNA in addition to the HPV DNA? (Plasmid is DNA from bacterial origin and is attached to the HPV L1 gene for production of the vaccine protein. It may be expected to be present together with the HPV DNA in the vaccine.) If Merck knew the HPV DNA was bound to AAHS to form DNA/AAHS complexes, where are the reports from the studies they must have performed on the pathophysiologic implications of using these complexes? Now here’s something that should be a ‘clincher’, I think. I understand HPV DNA was reported in the plasma of patients with invasive cervical cancer, which was known to be the source of HPV DNA in plasma. Furthermore, HPV DNA was not detected in plasma samples of patients who did not have cervical cancer. Jasmine did not have cervical cancer, as determined by autopsy. Therefore, she/her body should not have any HPV DNA from a cancer. What do you have to say to that? As stated previously, there are very few conditions under which HPV DNA would remain in a person’s blood and spleen long enough to be detected. This is one such circumstance. [References: Pornthanakasem W, etal. BMC Cancer. 2001;1:2; Shimada T, etal. Jpn J Clin Oncol. 2010;40:420-424] We’ve been talking about HPV L1 gene DNA in blood and spleen samples. Were any found elsewhere in Jasmine’s tissues? We have learned via a report from New Zealand that: Neuroscientist Professor Christopher Shaw of the University of Columbia in Vancouver told the inquest via video-link today that he was sent Ms Renata’s brain tissue to test. He said there was aluminum in all the samples he tested and there were some abnormalities in the samples. “The human papillomavirus (HPV16) was found in her brain, which could have only got there through the vaccine.” Prof Shaw said. Do you think the FDA should be looking for a cause-effect link between HPV L1 gene DNA-activated macrophages and lethal shock? Of course they should be looking! At the very least, they should be hunting down samples from every unexplained death after Gardasil® and sponsoring independent studies to determine if HPV L-1 gene DNA is present in others. They should also be looking at those reporting serious adverse events after Gardasil® for the same DNA. As it stands, the FDA is not living up to their mission statement, which states: “FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. “FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health…..” [Reference: http://www.fda.gov/aboutfda/whatwedo/default.htm ] Medical consumers have trusted the FDA to do exactly that – protect the public health and help them get accurate, science-based information – these trusting medical consumers have been betrayed. Norma, thank you so very much for this interview. I appreciate your cooperation in helping healthcare consumers understand issues authorities apparently don’t want to discuss. Catherine J Frompovich is a retired natural nutritionist who earned advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies. Her work has been published in national and airline magazines since the early 1980s. Catherine authored numerous books on health issues along with co-authoring papers and monographs with physicians, nurses, and holistic healthcare professionals. She has been a consumer healthcare researcher 35 years and counting. Catherine is an editor and writing consultant who helps authors get into publication. For numerous semesters she taught several writing courses for a suburban Philadelphia school district’s Adult Evening School. Her passion is assisting and guiding authors into print. Catherine’s latest book, A Cancer Answer, Holistic BREAST Cancer Management, A Guide to Effective & Non-Toxic Treatments, will be available on Amazon.com and as a Kindle eBook sometime in July 2012. Two of Catherine’s more recent books on Amazon.com are Our Chemical Lives And The Hijacking Of Our DNA, A Probe Into What’s Probably Making Us Sick (2009) and Lord, How Can I Make It Through Grieving My Loss, An Inspirational Guide Through the Grieving Process (2008). [SaneVax: Apparently, vaccines are not the only arena where the FDA does not live up to their mission statement. Is it any wonder disease caused by medical treatment is the number one killer in the United States when medical consumers cannot trust their government health agencies to do the job they are paid to do? Their apparent lack of responsibility and/or inability to do their job is killing us. Obviously it is time for a complete investigation of the FDA, not to mention prosecution of those found responsible for this appalling betrayal of the public trust.] Shocking Story Reveals How the FDA is Recklessly Abandoning Drug Safety By Dr. Mercola Exposed! In the wake of shocking reports on how the FDA, terrified of being outed for its questionable practices, spied on its own employees in the hopes of rooting them out before they could become whistleblowers, a new story has emerged on how deep the deceit goes. From marginalizing safety reports to not reading them at all―and then going ahead and approving the drugs in question―the FDA once more stands accused of being little more than a rubber-stamping agency for Big Pharma. Using sophisticated spy software, the agency tracked and logged every move made by the targeted individuals. The program even intercepted personal emails and copied documents on their personal thumb drives. The targeted scientists had expressed concern over the agency’s approval of dangerous medical imaging devices for mammograms and colonoscopies, which they believe expose patients to dangerous levels of radiation. Now, another whistleblower has stepped forward, and what he has to say about the agency’s drug safety reviews is shocking even to the jaded… Former FDA Reviewer Speaks Out About Systemic Suppression of Safety Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug Evaluation and Research from 1998 to 2008. In a recent interview he reveals how the FDA bypassed or ignored safety issues on major drugs approved during his employment. In an interview for the online news magazine Truth-Out, he tells Martha Rosenberg1: “In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee. There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees. In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug’s approval – which of course was our job as drug reviewers – management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.” According to Kavanagh, people would be shocked if they knew just how malleable safety data is. As examples, he points out that human studies are typically too short and contain too few subjects to get a clear picture of potential risks. In such a scenario, even a single case of a serious adverse event must be taken very seriously, and data from other longer term safety studies also need to be carefully analyzed. Kavanagh claims he has seen drug reviews where the medical safety reviewer completely failed to make such evaluations prior to the drug’s approval. |
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