Showing posts with label Merck. Show all posts
Showing posts with label Merck. Show all posts

Tuesday, May 21, 2013

Gardasil: the journey no one should take…

Gardasil: the journey no one should take…

By Stephanie’s Mother
Hospital Bills: $2 million after Gardasil
Hospital Bills: $2 million after Gardasil
I write this story hoping it helps save at least one girl; then our journey will not have been in vain.
I will barely touch the tip of the iceberg; so much has happened over these past 4-5 years. It has been a whirlwind and like a whirlwind – an unwelcome event.
Stephanie was 23 years old at the time of her 1st Gardasil injection. As most young adults, she was working, had her own health insurance and took responsibility for her health and medical decisions. She had been a Type I diabetic since age 10 and knew the importance of taking care of herself.
At her regular check up, the doctor said she needed to get this “NEW” vaccine for humanpapilloma virus (HPV). So our journey began.
Steph received her first shot in June 2008; the second in October 2008. The night of her second vaccine, Stephanie was admitted to the intensive care unit with an acute respiratory problem and sky rocketing blood sugars.
The 3rd injection was in December 2008.  Early in 2009, Stephanie took a trip to Mexico. On the way back she experienced uncontrollable vomiting, headaches and body aches. Once again she was hospitalized.
Thinking she may have picked up something while in Mexico, we pressed the hospital and doctors to check for parasites and pathogens. All tests came back negative.
She was hospitalized over and over again with the same symptoms. Test after test revealed nothing. Finally she received a diagnosis of gastro paresis, thought to be a result of her diabetes.  Her body was also full of yeast. One gastric empting test came back inconclusive, another came back slow.
Here is the clincher; we did not give any thought to the vaccine because we did not know she had the vaccine. It was not until we started realizing that her symptoms were not exclusive to gastro paresis, that I pressed Stephanie asking what she may have done differently or been exposed to.
This is when she said, “Well, I had a vaccine.” Keep in mind she was an adult who trusted the doctors. She did not think this was relevant – they would not give her something to hurt her.
It would be close to 2 years before realizing what could have caused Steph’s “mystery illness.”
While on my Facebook page, a large flashing ad on the left of my screen shouting ‘One more girl’ got my attention. I clicked on it and found that several girls had the same symptoms. I had so many questions! How was this vaccine tested? What did the package insert say? Did any other of these girls have compromised immune systems like Steph with her type I diabetes? Was it tested on this group of girls? Why do some get sick but not all? Why so many? Why had other countries already taken the vaccine off the market? We felt like we had played Russian roulette and lost.
This was just the beginning of the long, long journey into our Gardasil nightmare. Since this time, Stephanie has been hospitalized over 80 times. She was in for 3 weeks in southern California. This time on a purely liquid diet, hooked up to IVs, gaining weight and still vomiting. She had headaches, a disrupted menstrual cycle, large weight gain, itching, hair loss, body aches, depression, and extreme mood changes. She has had EVERY test in the book – over and over again.
Not one doctor that we encountered has yet to look at, or even consider the vaccine as a possible cause. They have blamed everything from diabetes to being psychologically sick. Some doctors have gone so far as to say they think we are crazy.
Her last doctor in southern California finally looked at some other girls’ stories and the website SaneVax. He threw his hands up and said, “If this were my mother, daughter, sister or aunt, I would go and get a second opinion.”
Keep in mind by this time; Steph has had every blood test, scope, scan and lab test available. All pretty much inconclusive or if it came back positive once, it was not positive again. They pumped her full of anti-nausea meds, antibiotics, fluids, painkillers, and anti-fungal over and over again. Each and every hospital visit we would have to go over the same thing. Each and every time we would get the same treatment.
We were always told by the hospitals, “We don’t fix people here; we just get them well enough to follow up with their primary physician.” I could not get them to understand that she is hospitalized so much that by the time she gets out and gets an appointment with her primary doc, she is sick again and admitted to the hospital.  We have had 2nd 3rd and 4th opinions.
These symptoms are brutal. The vomiting is not something that stops on its own and is accompanied by brutal stomachaches as well. Now you tell me, how does a person who is vomiting more days out of their life than not gain weight?
It is almost like she has gone into menopause with the hair loss, mood swings, night sweats, and hot flashes. This vaccine disrupts the entire neurological and endocrine system.
Stephanie’s Cobra insurance ran out, so she is now uninsured and unable to work, with hospital bills over 2 million dollars.  I decided to move her to Northern California so she would be closer and maybe get fresh start with new doctors. She had already been hospitalized numerous times in Southern California in 5 different hospitals.
The move north proved to us that the medical field is not willing to take responsibility or go against “Big Pharmaceutical” companies.
To date, Steph spent most of April 2013 in the hospital. We went so far as to have her gall bladder removed hoping this would stop her uncontrollable vomiting. Wrong again. The doctor actually told us, “So what if it is the vaccine, what are we going to do about it?”
Today, Steph is 27 and on disability and Medicare. Still, not one doctor is willing to look further into the possibility the vaccine may have caused her symptoms.
Her visits to the hospital are coming farther apart. There is a series of things that happen before she gets sick. She becomes extremely tired, will “swell up,” get extremely bad migraines and body aches, then the vomiting will start.  She will vomit with no food in her system, multiple times a day – for days. This seems to occur about every 3 months.
Stephanie is not alone, there have been over 130 deaths and 29,000 adverse reactions reported. Keep in mind; these are only reported reactions. How many other families have sick adult daughters that have not put two and two together?
Why in the world would anyone want 12 year olds to get this vaccine without having to tell their parents? A 12 year old that became sick from this vaccine without parental knowledge would never be able to connect the two! And their horrible journey into Gardasil prison could begin just that easily.
I just hope that all of our girl’s stories help to get the word out that this vaccine is a killer! One way or another it destroys lives.
Please understand – all 3 of my children had their childhood vaccines. I was not anti- vaccine until this. We feel the medical community has abandoned us.  HPV vaccines were “fast tracked” to the main stream medical community without sufficient testing to deem them safe for anyone.
Please do not even consider this vaccine, it has damaged and killed more girls throughout the U.S. and other countries than the disease it was meant to protect against!
If you take one thing away from my daughter’s story, it should be clear as a bell – DO NOT AGREE TO PLAY GARDASIL ROULETTE!

Sunday, May 5, 2013

We had no informed consent before Gardasil changed our lives.

 

May 3
By Glenda Smith
 
I was reluctant to grant permission for Angela to take the HPV vaccine in the fall of 2010. I remember thinking my daughter doesn’t need this, BUT maybe I’m not being a responsible mom if I don’t get it for her. According to the information I was given, the only risk was if you had a ‘severe immune disease e.g. HIV.’ I knew Angie had some chronic fatigue and celiac, but it said “SEVERE” and “HIV” – those are STRONG words that didn’t seem to fit Angela.
 
Gardasil changed my  life.
Gardasil changed my life.
 
So, trusting what I know now to be a vague and ‘ill-informed’ piece of paper, I signed and she began her shots.
 
April 14, 2011, Angie was 13 years old and in grade 8 when she received her last dose of HPV vaccine.
 
April 15, 2011, Angela called me at work feeling ill, nauseous, and dizzy and in severe abdominal pain. We thought she had eaten some wheat, but we checked everything. The pain never went away! It only got worse when she ate. She cried and cried in pain.
 
Angela never made it to her 8th grade graduation trip. For that matter, due to extreme weakness, severe abdominal pain, nausea and dizziness, she missed the last three months of grade 8. Trips to the family dr. and blood work accomplished nothing, not even an avenue that looked at her last immunization. An endoscopy even revealed her celiac under control. Over the summer pediatrician put her through test after test revealing nothing, yet her symptoms persisted. Pediatrician began to doubt Angela’s sincerity and eventually wanted her to be seen by a psychiatric clinic in the city. There was no way we going to put her through that. Angela was a stable, determined, and faithfully patient young girl.
 
It wasn’t until I reported her side effects to the local health unit I found out the HPV shot was Gardasil. It was only after I reported adverse reactions that the local health unit directed me to the manufacturer’s website and Merck’s product monograph. I was appalled at the very long list of side effects worded much differently than the information I had been given. It included phrases like a ‘weakened immune system’ as one of the risks. At the bottom of the list it stated “this is not a complete list of side effects.” Had I been given an opportunity to read this ahead of time, I would have never agreed to Angela receiving Gardasil at all.
 
I quickly asked our local health unit why this was not a part of the information we received along with the permission form. They simply replied, “We are not required to.” A little research and a quick look under Canada’s Health Act shows that indeed they are required to provide all risks, benefits and adverse side effects no matter how minor OR severe. In addition, they are required to provide alternative treatment options – which I now know to be simple regular pap tests. It was obvious that this whole HPV vaccine process was a manipulation tactic.
 
When 14 years old, Angela began going to Toronto’s world renowned Hospital for Sick Children’s GI department and various specialists. More and more blood work, procedures, MRE, stomach emptying test, and the list goes on. Yet another endoscopy and colonoscopy revealed inflammation here and there. “Cause unknown… Let’s just treat it,” was the approach. So she is put on medication after medication – dealing with side effects and no improvement.
 
Grade 9 begins and Angela miraculously makes it through about 6 weeks, attending school maybe 3 times per week. Then it was all too much and she just crashed – not able to even get out of bed for days at a time. More blood work. Still nothing shows up. Instead of earning 8 credits and enjoying a new life in high school, we had to plead over and over to get her home instruction, and that was for only 2 credits!! By now, things are taking an emotional toll on her (and I) as well as physical.
 
Angela has jumped through hoops for doctors who say this and that. She exhausts herself trying to do as she is told by them. Now just over two years later, she has basically NO trust in doctors.
January 2012, the abdominal pain seemed to be masked by extreme ‘roll around the floor crying’, bloating! This went on for months. She was admitted to our sick kids’ hospital April 30, 2012 for 2 weeks, put on an NG tube (tube through the nose to the stomach) and fed Tolerex, a nutritional formula. She was not allowed ANY food or drink this whole time! Right off the bat it made her feel worse and the bloating worse, but despite her crying and crying, they pushed to keep her on it. The 2 most upsetting weeks she will ever remember!
 
And then, it was almost a week at home on it before we said, NO MORE! As it turns out now, we find she is VERY sensitive to carbohydrates, and the first ingredient in the Tolerex was potatoes starch. More suffering for nothing…
 
Angela is almost 16 years old now. Doctors are now considering Gardasil as a possible cause for her mysterious auto-immune condition(s), but only at our urging with us providing scientific evidence to back up our statements. She attends grade 10 only 2½ hrs per day, 3 or 4 times a week if she is lucky. When will she ever be able to catch up in school and regain her life???
 
Angela has a GI specialist and nurse, a pain clinic team, an adolescent teen nurse practitioner and psychologist, and is part of the Seattle Children’s hospital online study helping teens live with chronic pain. Angela has two naturopathic doctors, a nutritionist, and sees a medical doctor who runs a naturopathic clinic. She has tried vitamin/mineral IV treatments, is expected to take over 20 supplements a day, which make her gag and has changed very little for her, her diet is very limited. She is able to eat very little without increasing pain and bloating from the level she constantly lives with, and is still trying acupuncture. She is exhausted with always ‘trying’ one thing after another having nothing alleviate her symptoms.
 
Before Gardasil, she had her celiac completely under control, and despite living with some chronic fatigue, she made basketball teams at school, volleyball teams, took trampoline, gymnastics and enjoyed horseback riding and hanging out with friends and was an ‘A’ student at school. Her one ambition and excitement was to try out for the high school basketball team; an ambition she never got to pursue.
 
Now, only being able do ‘light’ activity 2-3 hours per day, none of these sports are realistic. If Angela pushes herself one day, it will take 3 in bed just to return to her ‘already’ weak self. Over the past two years she has seen friends very little because she can’t keep up with their energy and usually feels unwell. We have to specifically schedule limited social times or activity for her, and pick and choose how she will spend her valuable limited functioning time each day.
 
What plans for the future can she make like this? There is no cure. She often cries about missing out on the active things she once so enjoyed. It hurts when she sees her friends moving on and doing things that she cannot, like part-time jobs. Instead she lives every day with two, three or all of the following debilitating symptoms:
  • abdominal pain (1st thing she had, severe, worse after eating)
  • severe bloating (bloating is constant, and just worse after eating as well)
  • being extremely limited in what she can eat, not eating things she used to love
  • chronic digestive inflammation
  • nausea
  • weak, muscle weakness (feels like going to collapse, hard to hold herself up)
  • severe fatigue/tiredness
  • unrefreshed by sleep
  • dizziness
  • headache
  • ear pain (when really tired and more run down then usual)
  • feels like she should be shaking
  • unexplained rashes (over sensitivity to things like outdoors, lake water, certain clothes)
  • unexplained itchiness
  • sharp pain down the side (hurts to move or breathe)
  • no energy, and if out and about more then 2-3hrs of simple activity per day, bed ridden for up to 3 days to return to ‘normal’ tired self
  • uncontrollable temperature variations; ‘hot’ or ‘really hot’ in an otherwise cool room (fan always on)
  • agitated
  • loss of good focus and concentration she once had (i.e. school work now difficult or sometimes impossible to complete)
We are scared. We have no idea when, or if, this will ever end. We have no idea whether any of us will ever be able to regain a ‘normal’ life.
 
I left my job only months after she got sick. Taking care of Angela physically as well as emotionally as a result of taking this vaccine IS my full time job. Our naturopathic doctor and a clinical nutritionist are who help us the most and who Angela feels most cared for by. We have incurred the cost of me not being able to work, in addition to the extra costs of healthy foods and supplements.
Angela is by ‘far’ not alone. She is on a private support group page with over 70 girls from all over the world which helps her tremendously. I am on with well over 1000 parents (more being added every day), all with children who are suffering similar or worse adverse effects, and these are just the ones who have found their way to a support group.
 
Although Angela suffers a great deal, we are still grateful as there are some girls who still have seizures after 5 years, some paralysis or neurological impairment, and there are those girls who have paid the ultimate price with their lives. There are still many out there who are not even aware that Gardasil may have caused symptoms they are living with. The adverse effects of Gardasil in the research and the evidence against the vaccine are staggering!
 
Had I researched then and found what I know now, we would have a healthy young teenager living a normal teenage life as was her right.
 
We share her story hoping to prevent this from happening to another family and to offer support to those it has already happened to. It is the only way to help Angela feel her suffering is not in vain. Keeping faith holds us strong.
 
Our message is simply this: “Investigate before you Inoculate!”
 
For more information, visit our site at www.sanevax.org.

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?

Monday, September 10, 2012

SaneVax Open Letter to Margaret Hamburg: When was the FDA informed of viral DNA in Gardasil?





The Honorable Margaret A. Hamburg, M.D., Commissioner September 10, 2012
U. S. Food and Drug Administration (FDA)
10903 New Hampshire Ave.
Silver Spring MD 20993-0002

Dear Dr. Hamburg:
In a public announcement, the FDA stated:
“Since the early development of Gardasil, FDA and the manufacturer (Merck and Co., Inc.) have known that after purification of the vaccine, small quantities of residual recombinant HPV L1-specific DNA fragments remain in the vaccine.” 1
This letter requests copies of the documents from the FDA showing:
1) The date when the FDA and the manufacturer first knew small quantities of residual recombinant HPV- L1-specific DNA fragments remain in the vaccine.
2) The physical condition of the HPV- L1-specific DNA fragments in the Gardasil® vaccine.
We are asking these questions because we have read the news report about Dr. Sin Hang Lee’s testimony delivered to the coronial court in New Zealand. During the inquest, Dr. Lee claimed to have discovered HPV L1 gene DNA fragments in the postmortem blood and spleen from a teenage girl who suffered a sudden unexpected death 6 months after the last dose of Gardasil® vaccination. The original pathologist reported he could not determine the cause of death in this case.
We have also read the advanced copy of a scientific report authored by Dr. Lee, being published in a peer-reviewed journal, entitled “Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®.”2 In this article, Dr. Lee stated:
“The detected HPV DNA was found to be firmly bound to the insoluble, proteinase-resistant fraction, presumably of amorphous aluminum hydroxyphosphate sulfate (AAHS) nanoparticles used as adjuvant. The clinical significance of these residual HPV DNA fragments bound to a particulate mineral-based adjuvant is uncertain after intramuscular injection, and requires further investigation for vaccination safety.”
Since the above-requested information is of paramount importance regarding the safety of HPV vaccines and consequently the protection of public health and safety, please know that this communication is being published as an open letter available on the internet to enhance public awareness. Copies are also being sent to the following interested parties:
Darrell Issa, Chairman, Oversight and Government Reform Committee
Representative Dan Burton (R-5-IN)
Senator Barbara Mikulski (D-MD)
Senator Charles Grassley (R-IA)
Senator Tom Harkin (D-IA)
Senator Orrin Hatch (R-UT)
We are looking forward to receiving the documents requested from the FDA so that our experts can analyze whether or not there is a potential link between the residual HPV L1 gene DNA fragments reported by the manufacturer and the various side effects observed in the vaccine recipients.
Thank you for your assistance,
Norma Erickson, President
SaneVax Inc.
Signed on behalf of the Board of Directors, SaneVax, Inc.
Rosemary Mathis, Vice President Victim Support
Freda Birrell, Secretary
Linda Thompson, Treasurer
Stephen Tunley, Australian Liaison
References:
  1. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm276859.htm
  2. http://dx.doi.org/10.1016/j.jinorgbio.2012.08.015

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.

Friday, August 3, 2012

SANEVAX GARDASIL VACCINE VICTIM OF THE WEEK!

Before you become a victim, investigate before you vaccinate. The life you save may be your child's.

Victim of Gardasil Vaccine: Naomi from Australia

Naomi from Australia



Naomi, Australia: Prior to Gardasil, Naomi was a happy, healthy 25 year old completing her Bachelor’s degree while working full-time in administration. She was about to embark on a Post Graduate Degree in Journalism. Despite being kept busy by work and study, she found the time to go out with friends and dance at their favorite club almost every weekend.
During 2008 and 2009, Naomi’s health mysteriously began to deteriorate into a myriad of inexplicable symptoms including dizziness, nausea, joint pain, a collapsing knee, loss of balance, chronic fatigue and weakness.
Even though she visited a multitude of health professionals, including both general practitioners and specialists, who performed a broad range of tests; no one was able to say what was wrong with her.
Tests confirmed an autoimmune reaction and an MRI showed some demyelination in Naomi’s brain similar to that experienced by MS patients. However, nothing was definitive. She was given pain killers and steroids, but no real explanation.

Just prior to Christmas in 2009, Naomi by chance read an article in the newspaper about a possible link between Gardasil and multiple sclerosis.
She collected her medical file and created a timeline. It showed that her symptoms had begun within weeks of receiving her first vaccination. The onset of the worst symptoms coincided with the receipt of her last vaccination. Immediately, she began to research on the internet. What she discovered was a plethora of other girls with stories just like hers.
Fourteen months after her last vaccination, Naomi is still on steroids. She was forced to discontinue her post graduate studies. She is unable to work full time and sometimes unable to work at all. Naomi still experiences daily symptoms including chronic fatigue and some neurological difficulties.
Despite maintaining a brave face throughout the Gardasil ordeal, Naomi feels like a shadow of who she once was or, could have been.
Naomi created this video, based on her experiences. She would like anyone who is considering an HPV vaccine to watch her video first. You can access it through the following link:
Written by Norma Erickson, Vaccines Examiner

Wednesday, August 1, 2012

.Shaw and Tomljenovich: Estimates of HPV Vaccine Safety and Efficacy

Christopher Shaw and Lucija Tomljenovic have once again hit the nail on the head when it comes to revealing the truth behind HPV vaccination policies and practices. Parents, you owe it to your child to be informed. INVESTIGATE BEFORE YOU VACCINATE.

Shaw and Tomljenovich: Estimates of HPV Vaccine Safety and Efficacy



[SaneVax: Christopher Shaw and Lucija Tomljenovic have once again hit the nail on the head when it comes to revealing the truth behind HPV vaccination policies and practices. In a recent letter to the editor of the American Journal of Public Health, they disclose that when comparing the adverse events reported after Gardasil to all other vaccines in the targeted age group, Gardasil alone is associated with over 60% of all serious adverse reactions in the VAERS database, including over 80% of all permanent disabilities. As a parent, are you willing to have your daughter risk permanent disability or death to take a vaccine that has not been proven to prevent a single case of cervical cancer?]

Who Profits From Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety?

Tomljenovic L, Shaw CA.

Source

At the time of the writing, Lucija Tomljenovic and Christopher A. Shaw were with the Neural Dynamics Research Group, University of British Columbia, Vancouver, Canada.

Abstract

We read with great interest the analysis by Mello et al.(1) on how Merck & Co., Inc. (Merck) influenced state human papillomavirus (HPV) vaccination policymaking. The exclusive reliance on Merck for scientific information on behalf of the legislators is unfortunate, especially in the light of independent research which has repeatedly warned that drug companies may manipulate clinical trial designs and subsequent data analysis and reporting to make their drugs look better and safer.(2-4) Indeed, careful scrutiny of Gardasil clinical trials shows that their design, as well as data reporting and interpretation, were largely inadequate.(4-6) (Am J Public Health. Published online ahead of print July 19, 2012: e1-e2. doi:10.2105/AJPH.2012.300837).
Access entire article via this link, or email the authors via the links above.

Sunday, July 29, 2012

The Refusers: Vaccine Protest Music Gone Viral

By Norma Erickson, President

Your Right

The first public performance of a now quite controversial rock band was in July 2010 at the American Rally for Personal Rights. In the tradition of protest songs during civil rights and anti-war movements, The Refusers presented their protest music as a tribute to vaccine-injury victims past, present and future.

Michael Belkin and his band use a unique musical style they have dubbed ‘Innoc-You-Rock’ to focus listeners’ attention on controversial vaccine issues. Their hard-hitting lyrics provide a direct counterpoint to what they see as “government issued vaccine propaganda and the current medical establishment’s policy of vaccinate first, ask questions later.”

The Refusers’ name was chosen in direct response to the American Medical Association’s position on informed consent, which says:

Your patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he or she can make an informed decision to proceed or to refuse a particular course of medical intervention.

Michael Belkin categorically states, “The AMA’s position on informed consent does not say ‘except vaccines.’ Vaccination choice is a fundamental human right. Any doctor who fails to inform you about the risks associated with vaccines, or who contends you do not have the right to refuse vaccination is violating their own medical code of ethics.”

What motivated Mr. Belkin to organize his vaccination protest band?

Flashback fourteen years: Michael is a successful, self-employed quantitative strategist happily married to the woman of his dreams. Lyla Rose was born with no complications – a healthy, happy baby girl. At five weeks of age, she is taken for a check-up and a booster shot of Hepatitis B vaccine. 15 hours later, Michael’s baby girl was gone.

Michael states that although the coroner initially stated Lyla’s brain was swollen (encephalitis), the cause of death ultimately ruled as Sudden Infant Death Syndrome (SIDS). The swollen brain and the hepatitis B vaccine were not mentioned in the final autopsy report.

Knowing that SIDS is a diagnosis of exclusion and brain inflammation is not SIDS, Michael’s research began. He discovered the following quote from Merck’s Home Health Manual:

Encephalitis can occur in the following ways:
  • A virus directly infects the brain.
  • A virus that caused an infection in the past becomes reactivated and directly damages the brain.
  • A virus or vaccine triggers a reaction that makes the immune system attack brain tissue (an autoimmune reaction).

Michael found himself attending any applicable government meeting he could. He attended a workshop at the National Academy of Sciences, Institute of Medicine on “Neo-Natal Death and the Hepatitis B Vaccine” and an Advisory Committee on Immunization Practices meeting on the safety of the hepatitis B vaccine. He obtained the entire VAERS database on hepatitis B adverse events reports and investigated it thoroughly.

In May of 1999, seven months after the tragic loss of his daughter, Michael Belkin presented the following testimony to Congress:





Michael continues to work within the system to promote vaccine safety and preserve the right to vaccine choice for many years. Although he experiences some small successes, Michael ultimately gets to the point where he feels he is beating his head against a brick wall. Those in charge of vaccination rules, regulations and policy-making just do not seem to care. Tired and wanting to return to a somewhat normal life, Michael takes some time off from vaccine safety and consent issues.

During his respite, he witnesses the development and marketing of several additional vaccines. He watches the autism rate climb to a previously unheard of level. He witnesses a substantial increase in the size of the VAERS database. He witnesses the increase in chronic and debilitating diseases in young people throughout the United States.

Michael went on to have two healthy unvaccinated children. He witnessed apartheid-like exclusionary policies being instituted against children whose parents chose to try and preserve their health and well-being. He witnessed people losing their jobs because they decided one vaccine or another was not in their best interest. He witnessed schools, daycares, and even medical professionals exclude people based on their vaccination status.

Michael Belkin decided enough was enough. The only option left was to take his message to the streets via a medium that might catch the attention of the average American medical consumer. Michael, his 11-year old unvaccinated son Sebastian, Steve Newton and Joey Walbaum decided to use their musical talents organize a protest band that would publicly stand up for everyone’s right to refuse vaccination.

The Refusers take great pride in their young drummer, Sebastian Belkin – a real deal healthy refuser – and visible proof that the unvaccinated are not the threat to public health and safety they are being portrayed as. Sebastian is the epitome of a normal healthy young man, not to mention talented.

Their strategy appears to be working. The Refusers first video, shown below, has officially gone viral with over 280,000 views. First Do No Harm, is also the title cut of the band’s soon to be released CD.





Michael Belkin and The Refusers have obviously found an effective way to get their message to those who need to hear it.

Listen to more music from The Refusers here.

Wednesday, July 25, 2012

Post-Gardasil Syndrome: Raquel from Spain three years later

Post-Gardasil Syndrome: Raquel from Spain three years later


By Norma Erickson, President


Gardasil: Safe, Affordable, Necessary and Effective is not too much to ask for.

The traditional media seems to overlook the fact that all of the victims of severe adverse reactions after HPV vaccines were originally trusting medical consumers who were simply following their doctor’s advice. They listened to the professionals when told that Gardsil or Cervarix vaccines could save their daughters from being a victim of cervical cancer. They were certainly not anti-vaccine, or they would not be in the position they are in now. This is the story of one of those families.

February 2009, at 14 years of age, Raquel received her second injection of Gardasil. A few hours later she was in a coma battling for her life. See her original story here.

It’s been over three years since Raquel suffered severe adverse effects after the second dose of Gardasil. She and her family suffered for two years wondering if they would ever see an end to her illness.

Now, they would like to let everyone who has been battling similar events that
Raquel is recovered! All of her neurological exams are now normal. She has not yet been discharged from hospital visits, but she leads a normal life.

With great effort she has completed her studies. Much to her credit, she has decided to continue school next year to become a nurse. Raquel wants to dedicate her life to healing others who have suffered like her.

Raquel’s parents have been beside her every step of the way during her long and arduous recovery. They believe all experiences in life, even very harmful, help us to find our way. They believe Raquel’s illness helped her find her vocation.

Raquel realizes that she is a lucky young woman. She could have been confined to a wheelchair indefinitely, but is not. With the assistance of doctors who attended her and the unconditional support of her family, she has overcome her illness.

Perhaps the most difficult thing for her parents to overcome was the helplessness of seeing how Health Authorities and some doctors wanted to dismiss her side effects to the vaccine as psychological, incidental, or coincidence.

Raquel and her family relied on Health Authorities when they decided to take the vaccine. To them, it is incredible and incomprehensible that the Health Authorities did not care about Raquel´s health after she suffered what was obviously an adverse reaction to the vaccine.

They now know their daughter will have a bright and happy future. They also know it could have very easily not turned out so well. They count themselves among the lucky ones.

Are Raquel’s parents vaccine safety advocates? You bet they are! They now dedicate a substantial amount of time and effort in an attempt to make sure what happened to their daughter never happens to another child. They encourage parents to do their research before they decide whether or not a vaccine is right for their children. They do not want anyone else to have to go through the horrors their family did for the last three years.

Raquel’s mother has a personal message to other vaccine-injury victims:

“I would like to tell all young people concerned to be patient. As long as there is life, never give up. If a treatment is not working, try something else. There are medical professionals out there who care about your health. I wish you strength and hope.”

Sunday, July 22, 2012

New Study: HPV Vaccine and Evidence of Herd Immunity or Type Replacement?

By Norma Erickson, President
 

HPV Vaccine: Herd Immunity?

 
Medical professionals rely on studies published in medical journals to keep abreast of new developments in their field. What happens when published studies raise more questions than answers? Where does that leave trusting medical consumers?
On July 12, 2012, Australia became the first country in the world to formally offer taxpayer sponsored HPV vaccines to their young men. HPV vaccines have been advertised as ‘cervical cancer’ vaccines. Boys obviously do not have a cervix, so how do you ‘sell’ males on the idea of a three shot series of the most expensive vaccine on the market?
Miracle of miracles – almost immediately press reports begin to come in from around the world about a new study that supposedly demonstrates evidence of HPV vaccinations providing protection to the unvaccinated population. What an outstanding way to convince boys it is their duty to protect those around them.
Unfortunately, none of the articles reporting this ‘miraculous’ development provide a link to the actual study so a person can check for themselves. So much for responsible journalism!
Vaccine-Type Human Papillomavirus and Evidence of Herd Protection After Vaccine Introduction,” by Jessica A. Kahn, MD, MPH, et al., was accepted for publication in April 2012 by the medical journal Pediatrics, but will not be formally published until August.1
Historically, academic ‘experts’ paid directly or indirectly by the industry have cherry-picked populations with a high prevalence rate of HPV infections or cervical cancer to generate a set of data. They extrapolate the ‘scientific’ data obtained from irrelevant populations to promote a vaccine with questionable value or an analytically inaccurate HPV test for use in the general population.
In 2001, a group of employees of the National Cancer Institute, a major patent holder and financial beneficiary of HPV vaccines, did just that when they used a population with an extremely high cervical cancer rate in a subpopulation of Costa Rica during development of the HPV ‘cancer’ vaccine and an HPV test for cervical cancer screening.2 Then they helped expedite approval of HPV vaccines and an inaccurate HPV test through the Food and Drug Administration to be used in populations with little threat of cervical cancer progression.
In their most recent study, Jessica A. Kahn and her coauthors have done the same thing by using a cherry-picked subset of African American women with an extremely high rate (68.3%) of HPV infection for a statistical analysis to justify wide spread implementation of the HPV vaccination policy through so called “herd protection.” The authors conveniently ignore the fact that most American women under the care of gynecologists in private practice have a less than 10% HPV infection rate even when the most sensitive nested PCR amplification is used for detection. They also ignore the fact that African American women usually carry different strains of HPV viruses than women from other ethnic backgrounds.3
It is well known that test results obtained in a population with high disease prevalence rates cannot be extrapolated to a population with a low prevalence of the disease. These authors knowingly misapply their statistical data to support this “herd protection” hypothesis as if HPV infection had become a contagious disease like influenza in the classrooms of all high schools throughout the world.
It is unfortunate that their opinion, supported by public funding, is published in the official journal of the American Academy of Pediatrics as a continued medical education material to influence the practice of the pediatricians, policy-makers and health authorities.
This is particularly true when a careful reading of Khan et al.’s article reveals the following points:
  1. Vaccine-type HPV infections reportedly decreased by 21.9% in vaccinated participants; but vaccine-type HPV infections also showed a decrease of 14.8% in the unvaccinated group when compared to the data from 2006-07. These changes are especially remarkable given that many participants were sexually experienced, presumably exposed to HPV, and only 1 HPV vaccine dose was required to be considered “vaccinated” in this analysis.
  2. The authors should know there are 3 subtypes of HPV-18, namely the European, the Asian-American and the African subtypes.4 In the U.S., 91% of the HPV-18 isolates from white women are reported to be of the European and Asian-American variants, and 64% of the HPV-18 isolates from African American women belong to the African variants.5 The production of the Gardasil® HPV-18 VLPs uses the HPV L1 gene from the SW756 cell line6 which carries an African subtype of HPV-18.4 Therefore, any “herd protection,” even if conveyed to a subset of African American women by Gardasil® vaccination, cannot be automatically extrapolated to other races or ethnicities.
  3. Why do the authors of the study consider one shot of Gardasil® to give the participants vaccinated status when the recommended dose is a series of three injections? If one shot is enough, is three too many?
  4. The study utilized the Roche Linear Array for HPV typing. According to World Health Organization documentation, only 8 of 17 datasets in a worldwide survey using the Roche Linear Array assay reported a 100% proficiency result in HPV genotyping.7 (table 2) In 7 of the 17 testing sets, false positive HPV types were detected by the Roche Linear Array assay.7 (table 3) This information brings the entire study into question.
  5. The authors of the study state, “the overall HPV prevalence increased “modestly” between the two studies.” How can this happen if the vaccine provides herd immunity?
Consider the following data taken from the soon to be published article regarding this ‘modest’ overall increase in HPV infections. This chart is a representation of HPV prevalence changes discovered when the post-vaccination surveillance group of 2009-10 was compared to the pre-vaccination surveillance data from 2006-07:
HPV
All
Vaccinated Non-vaccinated
Any Type 8.5% increase 9.0% increase 1.8% increase
High Risk Type 1.1% increase 5.2% increase 7.5% reduction
Vaccine Type (16/18/11/6) 18.3% reduction 21.9% reduction 14.8% reduction
High Risk Vaccine Type 14.2% reduction 17.8% reduction 12.0% reduction
Non-Vaccine Type 14.0% increase 15.2% increase 7.6% increase
Non-Vaccine High Risk Type 7.6% increase 13.6% increase 2.7% reduction
Why was there no statistically significant change in HPV infection rates among the unvaccinated participants? Does this mean that other types of HPV are taking over the role of the vaccine-suppressed HPV types in the vaccinated? If so, will the other types become more dangerous than the suppressed ones?
Does this mean the manufacturer targeted the wrong types of HPV for this population? Or, does it simply mean the vaccine doesn’t work?
Does this article provide evidence of herd immunity or potentially dangerous HPV mutation/type replacement?
Is this simply another example of the quality one can expect from industry sponsored ‘scientific studies’ destined to be blindly accepted and widely quoted to influence worldwide health policies?
This study raised far more questions than it answered. Medical consumers deserve better.
References:
  1. Kahn JA, Brown DR, Ding L, Widdice LE, Shew ML, Glynn S, Bernstein DI. Vaccine-Type Human Papillomavirus and Evidence of Herd Protection After Vaccine Introduction. Pediatrics. 2012 Jul 9. [Epub ahead of print] http://pediatrics.aappublications.org/content/early/2012/07/03/peds.2011-3587.abstract
  2. HPV co-factors related to the development of cervical cancer: results from a population-based study in Costa Rica. Hildesheim A, Herrero R, Castle PE, Wacholder S, Bratti MC, Sherman ME, Lorincz AT, Burk RD, Morales J, Rodriguez AC, Helgesen K, Alfaro M, Hutchinson M, Balmaceda I, Greenberg M, Schiffman M. Br J Cancer. 2001 May 4;84(9):1219-26.PMID: 11336474 [PubMed - indexed for MEDLINE] Free PMC Article Free textRelated citations
  3. Dunne EF, Unger ER, Sternberg M, McQuillan G, Swan DC, Patel SS, et al. Prevalence of HPV infection among females in the United States. JAMA 2007; 297: 813-9.
  4. Lurchachaiwong W, Junyangdikul P, Termrungruanglert W, Payungporn S, Sampatanukul P, Tresukosol D, Niruthisard S, Trivijitsilp P, Karalak A, Swangvaree S, Poovorawan Y.: Whole-genome sequence analysis of human papillomavirus type 18 from infected Thai women. Intervirology 2010, 53:161-166
  5. Xi LF, Kiviat NB, Hildesheim A, Galloway DA, Wheeler CM, Ho J, Koutsky LA. Human papillomavirus type 16 and 18 variants: race-related distribution and persistence. J Natl Cancer Inst. 2006 Aug 2;98(15):1045-52.
  6. Hofmann KJ, Neeper MP, Markus HZ, Brown DR, Müller M, Jansen KU. Sequence conservation within the major capsid protein of human papillomavirus (HPV) type 18 and formation of HPV-18 virus-like particles in Saccharomyces cerevisiae. J Gen Virol. 1996 Mar;77 ( Pt 3):465-8
  7. http://jcm.asm.org/content/early/2012/04/19/JCM.00840-12.abstract

Tuesday, June 26, 2012

Former Merck scientists file suit against Merck under False Claims Act



NaturalNews) On April 27, 2012, a formal complaint was filed in the Eastern Pennsylvania Federal District Court accusing Merck of a longstanding scheme to mislead and defraud Government health authorities worldwide. Two of Merck's former employees have accused the pharmaceutical giant of marketing multivalent MMR vaccines under false pretenses. According to the complaint, these vaccines have been mislabeled, misbranded, adulterated and falsely certified as having a 95% efficacy rate.

Before the lawsuit was filed, 21 doctors1 added their voices to other groups of doctors who are calling for MMR vaccines to be used as a regular booster every 4 - 8 years, in order to control mumps outbreaks. These doctors all assume that the mumps component of all MMR vaccines have the 95 - 98% efficacy promised by Merck.

However, the court documents filed by two Merck virologists meticulously detail how Merck ostensibly manipulated test results 2 for decades in order to create a false 95% efficacy rate for the mumps component of their multivalent MMR vaccines.

The former Merck virologists contend that the multivalent mumps component has a vastly reduced efficacy which is directly responsible for mumps outbreaks during the last decade which prompted international calls for MMR booster shots every 4 - 8 years.

Virologists Stephen Krahling and Joan Wlochowski describe how Merck had to recertify the mumps component in 2000, in order to comply with regulatory requirements in order for the mumps component to be included in two new multivalent MMR vaccines. The usual test, which had certified the mumps component's efficacy in the 60's, failed when used in 2000. They claim the results were so low Merck decided to change its own test protocol by testing the vaccine against the weakened mumps vaccine virus instead of the wild (naturally circulating) mumps virus.

When that modification didn't result in the desired 95% efficacy figure, Merck's executive directors of vaccine research, Drs Alan Shaw and Emilio Emini, instructed Drs David Krah and Mary Yagodich to implement a vast array of modifications to testing procedures3, then, allegedly pressured both Krahling and Wlochowski to participate.

When these modifications also failed to demonstrate the desired 95% efficacy rate, it is alleged that Drs Shaw and Emini instructed Drs Krah and Yagovich to abandon "gold standard" testing, and implement a new procedure, supposedly with the agreement of FDA, which included adding animal antibodies to human blood samples taken both pre and post vaccination4.

By combining the very low levels of human antibodies with animal antibodies, a much higher total level of virus neutralization was obtained than could occur from human antibodies alone. The human antibody levels alone would never protect in the real world against wild mumps. But after adding animal antibodies, the human blood samples which had previously failed under the old "gold standard" testing were retested using the "enhanced" protocols and passed with flying colors. New 'enhanced' tests showed 100% efficacy, not against wild mumps virus, but against the mumps vaccine virus.

However, combining the animal and human antibodies led to a new problem. In some of the tests more than 80% of pre-vaccine blood samples now showed up as immune. Usually, the highest number of pre-vaccine immune results any scientist could expect is 10%. Further manipulations of the animal antibody levels failed to bring the pre-vaccine blood test results down to the expected 10% levels.

According to the complaint, Merck then implemented additional 'creative' strategies to show a lack of seroconversion in immune samples in an attempt to reduce the pre-vax level to the expected 10% because had the FDA seen the high numbers of "immune" pre-vaccine samples they would have easily detected the fraudulent test procedures.

Krahling and Wlochowski worked with the same team conducting these tests, but were outraged at what they deemed to be gross scientific deception and fraudulent practices.

When Drs Krahling and Wlochowski attempted to stop what they saw as, "wholesale fabrication of test data to reach its preordained 95% efficacy threshold," Merck allegedly made various attempts to prevent them, including threatening to jail Dr. Krahling should he inform the FDA.

Despite these efforts, Dr Krahling made numerous calls to FDA. These calls remained unanswered until Dr. Krahling reported to the FDA that Dr. Krah had removed and/or destroyed Dr. Krahling's evidence.

An FDA agent then came and interviewed Dr. Krah, who apparently told the agent whatever was necessary to allay their concerns. The agent made no attempt to interview any other personnel, check any facilities, laboratory notebooks, or samples to corroborate what had been reported to them.

The lawsuit claims that to this day, Merck has consistently misrepresented the potency by simply quoting the 40 year old data from the pre-MMR monovalent mumps vaccine, thereby misrepresenting the efficacy of four multivalent vaccines: MMR, MMRII, Europe's MMRvaxpro, and ProQuad, which is MMR plus chickenpox.

According to the two whistleblowers, not only have all the multivalent MMR vaccines been sold under false pretenses, but, as a result of this LACK OF EFFICACY, there have been numerous mumps outbreaks worldwide prompting calls for regular MMR boosters throughout life. These mumps outbreaks were predicted by Merck's Dr Krah6in 2001, yet Merck allegedly 'willfully' withheld this information from multiple governments while consistently claiming there was no need for a new mumps component.8

The question is, "If the mumps component is actually 95% effective, as stated, would experts be calling for lifelong boosters every 4 - 8 years?"

Has Merck turned over a new leaf since the recent Vioxx Scandal? Do they still put profit before people? Read the complaint, follow the court case, examine the evidence, and decide for yourself.

References:
1. http://journals.cambridge.org
2. Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
3. See pgs 10 and 11 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
4. See page 12 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
5. See page 22 No. 64 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
6. See page27/d82; 28/85 and page 40 first two lines - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
7. See page 29/86 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
8. See page 29/87 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf

By Hilary Butler, Contributing Author from New Zealand.

Please visit our site at http://sanevax.org/.


Learn more: http://www.naturalnews.com/036298_Merck_scientists_False_Claims_Act.html#ixzz1ywbgZ6om

Tuesday, February 7, 2012

Gone after Gardasil: Acceptable collateral damage?



(NaturalNews) According to government health authorities, medical 'experts,' and the pharmaceutical industry adverse events after vaccinations are extremely rare. The attitude of these organizations toward individuals who do experience an adverse reaction to vaccines was recently summed up quite clearly in an article titled, The Value of Life, Statistically Speaking by Rick Jones, CFO magazine which stated:

"Inoculating children to prevent infectious disease transmission is good for society from both health and financial perspectives, but some initially healthy children may suffer adverse reactions, injury, or even death. For vaccines, the enormous societal benefits trump the tragedies of the few."



In other words, those who suffer adverse reactions, injury and even death are viewed as acceptable collateral damage, nothing more than statistics. Allow us to introduce you to a small sample of the statistically 'rare' adverse events after receiving the HPV vaccine, Gardasil:

Jessie Ericzon: Jessie was one of those rare individuals who truly had a zest for life. In her universe everyone deserved a fair chance and she made it her personal mission to make sure everyone around her had one. She excelled at everything she tried; truly an individual who had the world by the tail.

All of her hopes and dreams came to an abrupt end on February 22, 2008. That is the day her parents discovered her dead on the bathroom floor a mere 40 hours after her third injection of Gardasil.
Jessie's parents are left to deal with the fact that their precious daughter is indeed 'One Less' woman who will have to deal with cervical cancer.'

Chris Tarsell: Chris was discovered dead in her college dorm room bed 18 days after her third dose of Gardasil. Her abrupt departure from this world has left a multitude of people wondering what happened to this sweet, spirited, generous and caring individual who had been such a credit to the human race.

Chris's coroner could not identify a cause of death in this previously healthy girl. Are those left behind supposed to believe some strange, 'coincidental' force of nature took her life as alleged by the CDC? Chris's death was not thoroughly investigated by the CDC/FDA. One would think they would at least talk with the family to gather information regarding pre- and post-injection symptoms? Shouldn't they do a statistical analysis of post injection deaths to determine the probability of these deaths being "coincidences"? Such an analysis was done by Dr. James Garrett in a report posted at www.gardasil-and-unexplained-deaths.com . This report concluded it is statistically untenable to claim that none of the reported deaths was related to Gardasil. Where are the government health agencies charged with protecting the health and safety of the people who pay their wages? Why are they using inadequate data provided largely by the manufacturer to track vaccine safety? Why is the fox guarding the hen house?

Annabelle Morin: Annabelle ended up in the hospital with aphasia (the inability to understand spoken or written words) and great difficulty standing 16 days after her first dose of Gardasil. None of her family knew Gardasil had been administered, so no connection was made between her symptoms and the vaccine. 15 days after her second injection, this 14-year-old, French Canadian girl came home from school, had her dinner and went to take a bath and read a book. Half an hour later, with no warning, she was gone.

Once again, the coroner could not identify a cause of death. Did this spur a complete investigation to find out what may have caused her death? No! Canadian health authorities seem no more concerned than their counterparts in the United States.

One more precious life cut short leaving family, friends and neighbors wondering why no one seems to care what happened. Why is more investigation done for an accidental death than one that no one, including the coroner, can explain?

Jasmine Renata: Jasmine received her first injection of Gardasil in September 2008. One month later, she developed warts on her hand and very dry skin. The warts were taken care of, but shortly after the second shot, they returned along with bouts of dizziness, numbness and tingling in her hands, abdominal pain and memory losses.

On March 17, 2009, Jasmine got her third and final dose of Gardasil. Her condition quickly deteriorated. She became more agitated, continuing to complain of tingling in her hands and feet, along with various other new symptoms. Her memory losses were so severe she could not remember simple things like how to grate carrots. Shortly after, she began to experience chest pains and rapid heartbeat.

Just a little over 6 months after her third injection of Gardasil, this once healthy, hard-working 18 year-old girl died in her sleep. The 22 of September 2009 was the last day of her life. Jasmine's coroner ruled out drug and alcohol abuse as potential causes of her death. But, much like the other girls, no cause of death could be established. How do the health authorities in New Zealand respond when a young woman dies suddenly with no apparent cause? Unfortunately for the Renata family, they responded much like those in the United States and Canada. They do not appear to be concerned - just another coincidence, apparently.

Megan Hild: At 20 years old, Megan was happy and healthy. She was studying radiology in college and looking forward to her planned marriage after graduation. She held life in the palm of her hand.

Megan was living away from home while attending college, so her mother was not totally aware of the health problems she experienced after taking Gardasil. Megan's new medical conditions included unexplained rashes, severe stomach pains, migraines, extreme fatigue and vaginal bleeding. Imagine the shock when shortly after speaking with Megan on the phone her precious daughter was found on her knees in the shower of her college apartment - dead. Only after her sudden death would mom discover the new medical conditions Megan had after her Gardasil shots.

Megan's mother will not have the opportunity to watch her daughter's dreams come true. She, her family and Megan's fiance are left with nothing to hold onto but a piece of paper that reads, "Cause of death, unknown."

Megan's mother is still trying to grapple with the belief that a vaccine meant to protect her daughter's future health may have taken her life. She does not understand why no one in a position to investigate seems to care. She does not understand why health officials appear quite content to allow the cause of Megan's death to remain 'undetermined.'

These young women represent a small fraction of those who paid the ultimate price following Gardasil vaccination. It is common knowledge that only 1 to 10% of adverse reactions are actually reported to the Vaccine Adverse Event Reporting System (VAERS). Are these young women representative of 50 other devastated families or, 500 others? No one knows.

Try explaining to those left behind that their loss is acceptable for society's benefit when the only benefit Gardasil is clinically proven to provide is a 0.6% reduction in HPV 16 infections, and a 1.1% reduction in HPV 18 infections in vaccinated women versus unvaccinated women, providing they were not previously exposed to these two types of HPV prior to being vaccinated. (ATHENA study referenced below)

What about the 108 death reports filed with VAERS after HPV vaccine administration? How many others world-wide do they represent? 1,080? 10,800? Once again, no one knows. At what point does the collateral damage become unacceptable?

Explain to these families why they are left to their own devices if they want to know what caused their child's death. Had these deaths occurred after the use of any product other than a vaccine, the offending product would have been promptly removed from the market pending the outcome of investigations to determine the cause of the problem.

There is no valid excuse for the situation to be different with vaccines. It is high time for the FDA/CDC and every other government health agency worldwide to man-up and actually do the job they are paid to do - protect public health and safety. Investigate each and every death thoroughly. Determine the causes.

It should not be up to the survivors to prove a causal relationship; it should be up to the manufacturer to show that none exists.

References:
1. http://www3.cfo.com
2. http://www.ncbi.nlm.nih.gov/pubmed/21944226 (see table 3, The ATHENA human papillomavirus study: design, methods, and baseline results.) http://www.scribd.com/fullscreen/80272698
3. http://sanevax.org/gone-after-gardasil-jessica-new-york/
4. http://sanevax.org/gone-after-gardasil-christina-maryland/
5. http://sanevax.org/gone-after-gardasil-annabelle-canada/
6. http://sanevax.org/gone-after-gardasil-jasmine-new-zealand/
7. http://sanevax.org/gone-after-gardasil-megan-new-mexico/

By Freda Birrell and Norma Erickson, SaneVax Inc.

Please visit our site at http://sanevax.org/.


Learn more: http://www.naturalnews.com/034890_Gardasil_collateral_damage_fatalities.html#ixzz1lh8v64l5