[SaneVax: Medical consumers beware: the FDA may be trying to alter the definition of an adverse event! According to a recent article in The Clinical Advisor:
“An adverse event following immunization is classified as one that is “life threatening, and can result in death, permanent disability, congenital anomaly, hospitalization or prolonged hospitalization; or [one that] necessitates medical or surgical intervention to preclude these outcomes.”
Knowing that this was not the traditional definition of adverse event, the SaneVax Team took another look at the FDA website. It seems that as of 23 June 2011, the FDA no longer recognizes adverse events that are not considered serious. When doing a search for “adverse event definition FDA” this is now the most prominently displayed page. According to this page, the impression is that nothing is considered an adverse event unless it can be classified as ‘serious.’
Unfortunately, according to the Code of Federal Regulations (CFR) Title 21 (revised 1 April 2012) the definition of adverse event remains:
“Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.”
What will be the consequences of this shift in definition? Will minor adverse events be ignored until they actually become life threatening? What will this apparent ‘slight of hand’ definition cost in terms of human suffering?
The following story may give an indication of the potential negative impact, if the FDA is allowed to re-write the definition of adverse event. As medical consumers, you do not have to allow the FDA to change the adverse event definition.
Anyone can report adverse events to the Vaccine Adverse Event Reporting System (VAERS) – even those not considered ‘serious.’ If you have any new medical condition after vaccination – report it. Let the ‘experts’ sort out whether it is vaccine-related or not.
Sudden neurologic symptom onset in an adolescent
By Margaret Quinn, DNP, CPNP
Ms. K, aged 16 years, presented to the emergency department (ED) after being seen by her primary-care clinician 48 hours earlier for an annual physical exam and immunization update. Physical assessment was unremarkable at that time. During that exam, Ms. K received her third dose of the human papillomavirus (HPV) vaccine, Gardasil. Approximately one hour after administration, Ms. K’s mother found her unconscious and drooling and called 911.
Ms. K was seen in the local ED, where this was diagnosed as a transient reaction to the immunization. Following her discharge, Ms. K developed headache, photophobia, nausea and an unsteady gait. Since falling unconscious, the teen reported a headache on a pain scale of 7/10, photophobia, dizziness and difficulty walking. Ms. K’s pediatrician referred her to a regional pediatric center for further evaluation.
A frightening and worrying story about Ms.K.
FDA’s attempt to change the definition of adverse events to mean only serious adverse events may mean that the next step will be the publishing of a short list of (the only) conditions which are permitted to be registered as adverse events.
.INEFFICACY OF THE HPV VACCINE SEEN BY DOCTOR OF DEEP PERÚ
From its inception until the appearance of cervical carcinoma (UCC), takes on average 25 to 30 years, the research of this vaccine have begun in 2000, it is evident that the scientific efficacy of this new vaccine will be determined the years 2025 – 2030.
HPV not causes definitely the (CCU); at the onset of this disease involves multiple risk factors, including the suspected HPV, but scientificaly is proven by epidemiology and statistics that the sex is what generates this disease .: Mix in 130.000 nuns found not any UCC.
http://www.portalesmedicos.com/publicaciones/articles/1832/1/Epidemiologia-del-carcinoma-del-cuello-uterino.html
To accept that a virus or a bacteria causes a infection disease must unfailingly fulfill the five Koch’s postulate
http://www.xatakaciencia.com/salud/los-postulados-de-koch
1 – The agent must be present in every case of the disease and absent from healthy.
2 – The agent must not appear in other diseases.
3 – The agent to be isolated in pure culture from disease lesions.
4 – The agent of causing disease in a susceptible animal being inoculated.
5 – The agent must again be isolated lesions in experimental animals.
http://es.scribd.com/doc/44558220/MICROBIOLOGIA-1
Consequently, HPV not fulfill not any principle of Koch’s postulate. by not meeting this postulate, that is accepted as dogma in medicine, scientifically we must be ensure that the HPV is not the causative agent to the UCC..
Until August 2012 this vaccine produced only in the United States: 265.640 adverse events ( 264,162 females, 9490 males and 5290 unknow sex); permnent disability 8910( 8890 females, 90 males and 110 unknow sex), 1220 deaths (1011 females, 70 males and 140 unknow sex), abnormal PAP 4930, cervical dysplasia 1970 and cervical cancer 570
http://holyhormones.com/vaccinations/hpv-vaccine/hpv-vaccine-adverse-events-reported-to-vaers-as-of-july-13-2012/
http://therefusers.com/?s=cervarix
The Vaccine efects advers reactions (VAERS) ensures that only complaint between 1% to 10% of the adverse effects produced by this evil vaccine;this figures shown are calculated according to the statements of the VAERS: to 10%.
http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccion-adversa-a-la-vacuna-vph-d
http://www.pop.org/content/merck-researcher-admits-gardasil-guards-against-almost-nothing-985
Dr. Harper, who contributed to the development of the vaccine by Merck, reports that the vaccine was not investigated in children under 15 years and the vaccine given to children under 11 years is a big public experiment.
http://offtheradar.co.nz/vaccines/53-researcher-diane-harper-blasts-gardasil-hpv-marketing.html
The vaccine was approved to give girls uncontaminated with HPV, Dr. Howenstinc ensures that the women are vaccinated with HPV contaminated, have the possibility to acquire a 44.6% CCU
http://www.newswithviews.com / Howenstine/james170.htm.
Merck did not disclose that the vaccine was transgenic, the Sane Vax has discovered, which is transgenic because it has been found that the vaccine is contaminated with DNA recombinant vaccine Gardasil (DNArPVH) and has raised its concerns to the president of the FDA Margaret Hamburg. The FDA replied that the vaccine will not cause any damage transgenic
http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-recombinante-de-vph/
http://bolsonweb.com.ar/diariobolson/detalle.php?id_noticia=26075
A vaccinated child was ill with rheumatoid arthritis, which is an autoimmune disease. 24 hours after vaccination and found that the aluminum adhered to DNArPVH, two years after vaccination and in autopsy 6 months after death in a New Zeland girl Jazmine Renata which had recibed this deadly vaccines
http://www.mecfsforums.com/index.php?topic=9331.0
Management time to get market approval of a drug the FDA is at least three years, it is a drug for cancer 15 years, but the authorization Merck had only six months and the European Medicines Agency (EMA in English) only 9 months: To introduce the vaccine are using the marketing of fear
http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-del-miedo-67210961.ht http://mujeresenaccion.over-blog.es/article-vph-la-vacuna -of-marketing-of-fear-67210961.ht
HPV is ubiquitous; lives in wild and domestic animals, pollute us from birth, is on the doorknobs, on towels, on nails, on fomites, in gloves and specula of gynecologists,. sexual intercourse is not the only means of contamination.
http://spa.myhealthygood.com/cancer-cervical-vacuna-contra-el-vph/investigadores-descubren-el-v
HPV also lives in the 400 nm outermost of our skin and mucous membranes. ,
If you live in our skin, our immune system produces cellular and humoral immunity is acquired or that our body is self vaccinatinge by PVHs living on our skin and mucous ..
http://www.conganat.org/seap/bibliografia/HPVToday/HPVToday007SEAP.pdf
The PVHs is not distributed uniformly worldwide. It has been found that in Canada HPV 18 only reaches 3%; is more often HPV 31, in my country Peru no studies have determined that HPV types predominate; Gardasil contains 225 mcg. aluminum and Cervarix 500 mcg, that produce the Alzheimer, Parkinson and autism, produce too neurotoxic and immune system disorders (Blaylock 2012) and Polisorbato 80, a powerful contraceptive, that in experimental animals produces sterility, atrophy of the testicles and disturbance organic and funtional of the organs of the reproduction; is carcinogenic and mutagenic; also contains sodium borate considered poison unused in medicinal preparations (NLM)
http://www.telefonica.net/web2/paramahamsa/vacunaninosalerta.html http://detenganlavacuna.wordpress.com/2010/11/09/gardasil-cervarix/
Have been discovered to date 200 types of HPV; HPV is not infectious, contagious; the intercourse is not only that the persons is contaminated
http://www.asbmb.org/Webforms.aspx?ekfrm=46
http://quimicaclinicauv.blogspot.com/2006/08/virus-del-papiloma-humano.html http://www-lab.biomedicas.unam.mx/smpv/queeshpv.htm
On 22-11-2010 FDA approved Gardasil for males aged 9 to 26 to prevent warts and cancer to the anus, is overkill
http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-recombinante-de-vph/
http://salud.aollatino.com/2011/02/02/aprueba-fda-nueva-indicacion-vacuna-tetravalente-vph-eeuu/
For this reasons from deep Peru Huancayo, I believe that this vaccine is a fraud?, robbery?, swindle?, rough joke?.
The HPV is not scientifically proved for the moment that produce the UCC its effectiveness shall be verified just the years of 2025-2030.
Dr. Godofredo Arauzo
E mail: godo.ara@ gmail.com