Showing posts with label fda. cdc. influenza. Show all posts
Showing posts with label fda. cdc. influenza. Show all posts

Saturday, April 6, 2013

HPV Vaccine Safety: Has the CDC abandoned its mission?

By Norma Erickson
SaneVax-FeaturedWhat would happen if a vaccine turned out to cause more health problems than the disease it was meant to protect against? Are medical consumers watching this scenario unfold with HPV vaccines?
The U.S. Center for Disease Control (CDC) states 90% of all HPV infections clear on their own with no symptoms or medical treatment. Yes, human papillomavirus (HPV) may be one of the most commonly sexually transmitted viruses in the country, but in the vast majority of cases there are no serious health consequences to being exposed to human papillomavirus.
In those cases where infections with the same genotype of HPV persist over time, abnormal cervical lesions may develop. These abnormal lesions (CIN), classified 1, 2, or 3, are typically called ‘precancerous’ lesions. Not many people are aware of the fact that most CIN1 lesions go away on their own within two years. 25-50% of CIN2 lesions regress on their own within the same two year time frame. According to the International Agency for Research on Cancer (IARC), World Health Organization, the results of a pooled analysis of studies published between 1950 and 1993 indicated only 12% of CIN3 lesions progress to invasive cervical cancer.
Chapter 2 of the IARC’s COLPOSCOPY AND TREATMENT OF CERVICAL INTRAEPITHELIAL NEOPLASIA: A BEGINNER’S MANUAL states:
“Despite women’s frequent exposure to HPV, development of cervical neoplasia is uncommon. Most cervical abnormalities caused by HPV infection are unlikely to progress to high-grade CIN or cervical cancer, as most of them regress by themselves. The long time frame between initial infection and overt disease indicates that several cofactors (e.g., genetic differences, hormonal effects, micronutrient deficiencies, smoking, or chronic inflammation) may be necessary for disease progression. Spontaneous regression of CIN may also indicate that many women may not be exposed to these cofactors.”
Please note this manual was designed to teach medical and nursing personnel in developing countries where diagnostic and therapeutic expertise is not readily available. In other words, the progression from HPV exposure to potential development of cervical cancer is similar in both developing countries and developed countries. It also indicates that several cofactors (risk factors) may be needed for HPV exposure to progress to abnormal lesions, much less cervical cancer.
What does this mean for the average medical consumer?
  • HPV has not been proven to cause cervical cancer without other risk factors being present.
  • Persistent infections with high-risk HPV genotypes may lead to the development of cervical cancer if other risk factors are present.
  • According to the IARC, risk factors that contribute to the development of cervical cancer precursors and cervical cancer include infection with certain oncogenic types of human papillomavirus (HPV), sexual intercourse at an early age, multiple sexual partners, multiparity (giving birth two/more times, or giving birth to twins), long-term oral contraceptive use, tobacco smoking, low socioeconomic status, infection with Chlamydia trachomatis, micronutrient deficiency and a diet deficient in vegetables and fruits.
These are all facts that CDC officials know, or should know. Given this, how can these same CDC officials recommend and promote the universal use of HPV vaccines in an attempt to eliminate one risk factor involved in the development of cervical cancer?
Of equal concern is that the CDC knows the cervical cancer death rate in the United States has decreased substantially due largely to the introduction and wide use of pap smears.
The CDC would certainly know the side effects of pap smears, which are mild and limited to:
  • Slight pelvic discomfort or pain during the procedure
  • Temporary abdominal cramping during or shortly after the procedure
  • Mild vaginal bleeding for up to 24 hours following the procedure
CDC officials also know that pap smears can identify abnormal cervical lesions long before they progress to cervical cancer. The CDC knows pap smears already provide a safe, affordable, necessary and effective means of preventing cervical cancer and cervical cancer deaths.
Despite all of this knowledge, the CDC wholeheartedly recommends two HPV vaccines, Gardasil and Cervarix, claiming both protect against cervical cancer in women.
However, because pre-licensure clinical trials often do not detect rare adverse events or adverse events related to special populations, the CDC and FDA are both responsible for ongoing safety monitoring of HPV and other vaccines.
Vaccines continue to be monitored for safety after they are licensed. This is because pre-licensure trials are often too small to detect rare events and special populations may not be adequately represented. Since licensure, CDC and FDA have been closely checking the safety of HPV vaccines through 3 monitoring systems. These systems can monitor adverse events (health problems) already known to be caused by vaccines, as well as detect rare adverse events that were not identified during pre-licensure clinical trials. The 3 systems are:
VAERS relies on voluntary data reporting. Even the CDC acknowledges that adverse events may be 10 to as much 100 times the number actually reported.
“These vaccine safety studies continue to show that HPV vaccines are safe.”
A simple analysis of the VAERS database alone does not support the CDC’s claims. The chart below illustrates adverse events reported after Gardasil and Cervarix compared against reports after the 13 other vaccines recommended for ages 7-18, for the period of time HPV vaccines have been on the market. Why do HPV vaccines appear to be vastly over represented in the adverse events database?
Does this not indicate some sort of safety signal?
HPV Vaccines: No Safety Signal?
HPV Vaccines: No Safety Signal?
We discussed above the three side effects reported after pap smears, none of which are life threatening. Compare them to the following list of new medical conditions reported to VAERS after HPV vaccines:
Abortion/Stillbirth/Miscarriage, Addison’s Disease, Adrenal failure/problems, Allergies, Anxiety/Panic attacks, Appetite loss, Arthritis, Asthma attacks, Autistic–like symptoms, Autoimmune Disease (Lupus/Mixed Connective Tissue Disease), Back pain, Bacterial Vaginosis, Bladder issues, Bleeding gums, Blindness, Bloating, Blood Sugar Issues, Bloody stools, Brain fog, Brain Inflammation, Brain lesions, Bronchitis, Cervical cancer, Chemical sensitivity, Chest pains, Convulsions, Chronic Fatigue Syndrome, Constipation, Cytomegalovirus (CMV), Death, Degenerative disk disease, Dehydration, Depression, Diabetes, Diarrhea, Dizziness, Dyslexia, Dysplasia, Early Onset of Menopause, Enlarged fallopian tubes, Enlarged liver, Epstein Barr Virus (EBV), Extreme pain in the tailbone area, Fainting, Fatigue, Fertility problems, Fever, Fever blisters, Fibromyalgia, Food allergies, Gallbladder issues, Genital Warts, Gray film on teeth, Guillain-Barre Syndrome, Hair growth in strange places, Hair loss, Hallucinations, Hand/Leg Weakness, Hashimoto’s Disease, Head pressure, Headache, Hearing loss (Temporary/Permanent), Hearing sensitivity, Heart Palpitations, Heart arrhythmia, High levels of metals in blood: aluminium, mercury, Hot/Cold Intolerance, HPV, Infertility, Insomnia, Itching, IUD discomfort, Joint pain, Kidney Failure, Kidney issues, Knee pain, Leaky Gut Syndrome, Light sensitivity, Lip spots, Liver Failure, Loss of bladder control, Lupus, Memory Loss (short-term/long-term), Menstrual cycle changes, Metallic taste in mouth, Migraines, Miscarriage, Mood Swings, Moles, Mononucleosis, Multiple Sclerosis (MS), MS-like symptoms, Muscle aches, Muscle spasms, Muscle tension, Nausea, Neurological reactions to fungal metabolites, Neurological symptoms , Night sweats, Non-Hodgkin’s Lymphoma, Numbness, Other types of cancer, Ovarian failure, Paleness, Paralysis, Pancreatitis, PCOS (Poly-Cystic Ovarian Syndrome), Pelvic Inflammatory Disease (PID), Pelvic pain, Personality changes, Pins/Needles in Extremities, Pleural effusion, Pneumonia, Postural Orthostatic Tachycardia Syndrome (Orthostatic Intolerance), Random twitching of extremities Rash, Reynaud’s Phenomenon (loss of blood circulation to hands and/or feet), Regression, Rheumatoid arthritis, Ruptured ovarian cysts, Seizures, Sensitivity to commercially processed citric acid, MSG, sulfur and other additives, Severe nerve pain syndrome, Shortness of breath, Sleep Apnea, Slurred speech, Smell sensitivity, Sore throat, Sound sensitivity w/Anxiety, Stomach ache, Stomach pain, Sudden drops in blood pressure, Swelling/Edema, Swollen lymph nodes, Thyroid Issues, Thrombosis Toothaches/Teeth Changes, Tremors: hand and/or leg, Uterine spasms, Urinary Tract Infection (UTI), Vision loss (Temporary/permanent), Vision Problems – abnormal pupillary function/dilation, Vomiting blood, Weight gain or loss (20 – 30 lbs)
Keep in mind, a report to the VAERS system does not mean the symptoms were caused by the vaccine administered before the new medical condition appeared. A report to the VAERS does not mean the new medical condition is NOT causally associated with the vaccine either. VAERS is simply an ‘early warning’ system. It is up to the CDC and FDA to examine the reports to determine whether or not a safety signal exists.
Any reasonable person looking at the data would struggle to understand how the CDC can recommend the addition of HPV vaccines to the cervical cancer prevention protocol when there is such disparity between potential adverse events?
Any reasonable person would wonder how the CDC can recommend HPV vaccines as a good strategy for cancer prevention when pap smears have already reduced the cervical cancer rates so significantly without all of these potential risks, not to mention at a much lower cost to individuals and society?
Let’s examine the CDC’s mission statement
“For over 60 years, CDC has been dedicated to protecting health and promoting quality of life through the prevention and control of disease, injury, and disability. We are committed to programs that reduce the health and economic consequences of the leading causes of death and disability, thereby ensuring a long, productive, healthy life for all people.”
  • Accountability — as diligent stewards of public trust and public funds, we act decisively and compassionately in service to the people’s health. We ensure that our research and our services are based on sound science and meet real public needs to achieve our public health goals.
  • Respect — we respect and understand our interdependence with all people, both inside the agency and throughout the world, treating them and their contributions with dignity and valuing individual and cultural diversity. We are committed to achieving a diverse workforce at all levels of the organization.
  • Integrity — we are honest and ethical in all we do. We will do what we say. We prize scientific integrity and professional excellence.
Is the CDC living up to its mission statement?
CDC officials know continued pap screening is recommended by both HPV vaccine manufacturers, despite vaccination status because there are high-risk HPV genotypes not targeted by either Gardasil or Cervarix.
The CDC knows there are no reported deaths or permanent injuries reported after pap smears.
The CDC officials know or should know all of the facts outlined above.
Medical consumers need to ask themselves:
 
Has the CDC abandoned its mission in an effort to promote potentially dangerous vaccines of questionable benefit?

Tuesday, August 7, 2012

How to Create a Vaccine Safety Advocate

 

August 7, 2012

By Norma Erickson, President

Chris Tarsell: Gone but not forgotten

One would think everyone at the FDA and CDC would be a staunch vaccine safety advocate, but apparently that is not necessarily the case. How do you change a parent from someone who trusts their doctor and health authorities, following all of their advice into a determined vaccine safety advocate who is skeptical of health authorities?

Imagine for a moment you have one child, a lovely daughter, your pride and joy, who is away at college. She is the picture of health, bright, talented and athletic with dreams and ambitions, and well on her way to reaching her goals.

Then, one peaceful evening you hear a knock on the door. It is the police, there to inform you that your daughter was found dead in her bed for no apparent reason and with no signs of foul play. This happened in June 2008, when every parent’s worst nightmare became a reality for Emily Tarsell. Christina Tarsell had died in her sleep less than 3 weeks after her third and final injection of Gardasil®.

The nightmare continued. A complete autopsy could not determine a cause for her daughter’s death. Then after seeing a television interview with victims of Gardasil, Emily began to suspect a link between her daughter’s death and Gardasil.

Emily and her doctors filed reports with the Vaccine Adverse Event Reporting System (VAERS). Amazingly, she received no communication from the CDC, FDA, or any other government agency charged with the investigation of deaths reported after vaccination. Apparently, talking to the parents of the deceased person is not a part of an investigation into the circumstances surrounding a death after vaccination. The CDC/FDA provided no answers.

Emily subsequently learned that Merck, the vaccine manufacturer, had filed a VAERS report stating falsely that a viral infection caused her daughter’s death, even though there was absolutely no evidence Chris had a viral infection. Emily challenged Merck about the false statement. She provided letters and documents from doctors to show there was no evidence to support Merck’s statements. It took a year before Merck back downed from their false statement.


Finding no help from governmental authorities, Emily had no choice but to investigate on her own. Since Chris’s death, she has learned that the vaccine was falsely advertised and there is no evidence it will prevent cervical cancer. She was never informed that Chris was at low risk of developing cervical cancer and that the incidence of cervical in this country is very low. She realized consumers are intentionally uninformed by the medical and pharmaceutical establishment. If the true risks and benefits were known, consumers would decline the vaccine.

She has met and grieved with many other families whose daughters were injured or died following Gardasil. She co-authored a study based on victim’s reports which shows a strong correlation between adverse symptoms and increasing doses of Gardasil (Report concerning a survey of adverse events following inoculations with Gardasil). She now realizes, as the nightmare continues, that her only daughter died from a vaccine she didn’t need that serves little to no public or private good.

These three astounding discoveries changed Emily from a trusting medical consumer into a dedicated vaccine safety advocate:
  1. The apparent lack of initiative or concern by health authorities who are supposed to investigate adverse reactions and deaths following vaccination
  2. False reports from the vaccine manufacturer.
  3. False advertising regarding the safety and efficacy of Gardasil and lack of true information about cervical cancer prior to injections.
Emily has made it her personal mission to spread the word in the hope of preventing other families from experiencing what she has. She works tirelessly to make sure people have all the facts so they can decide whether Gardasil® benefits outweigh the risks prior to consenting to vaccination


Visit our site at www.sanevax.org.

Wednesday, July 25, 2012

Influenza 2012: Potential Conflicts of Interest and the Role of Media

By Stephen Tunley, Director, SaneVax Inc.

Where is objective journalism?

During the last few weeks in Australia we have seen an increase in the number of news reports (print and broadcast) regarding this seasons Flu outbreak. A number of them have quoted Dr Alan Hampson who has provided his ‘expert’ opinion and encourages all to get the Flu shot as this year’s Flu will be worse than last year’s and so on, and so on…..

What the media fails to explain is that the good Dr Hampson, spent a large part of his career working for Australian vaccine manufacturer CSL, the same manufacturer which recently admitted

“ .. its (flu) vaccine production methods probably triggered seizures in children, in the first results from its two-year investigation into the Fluvax fits.

But … refused to say if it would pay compensation to the families of children hospitalised after being immunised with Fluvax, which has been banned for paediatric use after sending one in 100 children into febrile fits in 2010.

The preliminary results of CSL’s two-year investigation conclude that its manufacturing methods may have failed to fully split the viruses used to make flu vaccines.

As a result, gene fragments and lipids from “inactivated virus” — as well as “residual whole virus or clusters of both” — may have created higher levels of immune-stimulating hormones, known as cytokines.”

Basically they screwed up – and 1 in 100 Aussie kids who received the shots got very ill.

The same Dr Hampson who recommends everyone get vaccinated against the flu this year because of the ‘dire threat’ of a serious flu season was responsible for developing influenza vaccine production processes for part of his time at CSL. He is Chairman of the Influenza Specialist Group an organisation whose financial support comes mainly from sponsorship from Abbot, Baxter, and CSL, pharmaceutical companies involved in the manufacture and sale of flu vaccine in Australia. In addition, he is also Editor in Chief of the International Journal “Influenza and Other Respiratory Viruses”, which lists as among its major sponsors two pharmaceutical companies Roche and Sanofi Pasteur. Roche via its Genentech subsidiary manufacture Tamiflu and Sanofi Pasteur the flu vaccine Intanza.

Given the reliance and general trust medical consumers place upon the opinions of these so called ‘medical experts’ the media has a responsibility to point out any potential of conflicts of interest; or find experts who are not conflicted?

Attachment 1:

Dr Alan Hampson, BSc, MSc, M.D. (Hon), FASM, OAM.

Dr Alan Hampson is a virologist with over 40 years experience working with influenza. His career includes responsibility for developing influenza vaccine production processes and senior R&D positions (Research & Development Manager) with the Australian biopharmaceutical group CSL Limited, and subsequently as Deputy Director and operational head of the WHO Collaborating Centre for Reference and Research on Influenza, Melbourne, from its designation in 1992 until his retirement in September 2005. Since retirement Alan has maintained an active role both in Australia as a consultant, Chairman of the Australian Influenza Specialist Group (ISG), a member of Australian Government advisory committees on influenza and pandemic preparedness, and internationally with the WHO including membership of its Pandemic Taskforce (now the International Health Regulations Roster of Experts) and Editor in Chief of the international journal ‘Influenza and Other Respiratory Viruses’. He also holds an appointment as Honorary Senior Research Fellow, School of Applied Sciences and Engineering, Monash University Gippsland Campus. Alan has received numerous awards and recognition for his contribution to public health, including: recipient of the Asia Pacific Society for Medical Virology Excellence Award (2006); an Honorary Doctorate of Medicine from the University of Melbourne (2006); the Order of Australia Medal for his contributions to public health, particularly with respect to influenza (2007); and was made a Fellow of the Australian Society for Microbiology (FASM) in (2007).