| “Jenny Tetlock (California – Northern) was a 15-year-old girl battling a rapidly degenerative neurological disease that some MDs think MAY be linked to the HPV vaccine she received shortly before her first symptoms appeared. (There is no scientific proof one way or the other but Dr Diane Harper, leading researcher who helped design and carry out Phase II and Phase III safety and effectiveness studies to get Gardasil approved and acted as a consultant to Merck, believes that the possibility of a triggering of a genetic disorder within a family has to be considered seriously).” From Jenny’s Journey Jenny passed away on March 15, 2009 surrounded by her family. Jenny’s Journey gives more details of the events surrounding this young girl’s sudden illness following her Gardasil vaccination.  Moshella Roberts, 20, a student from Fayetteville State University, Fayetteville, (Carolina - North). She died from the Gardasil vaccination, her first day on the job at Trinity Home Care, April 5, 2008. Shelly appeared to have died in her sleep while on the job that morning. Shelly was a funny, quiet and easy-going person. Although she had a ’laid back’ personality, she loved to help other people. In her spare time, she enjoyed doing hair and spending time with family and friends. In High School she was a varsity cheerleader, an active volunteer for her community (Special Olympics, make-up artist for a major play, and various town functions) and she received her C.N.A, all while maintaining a honor status. She received her post-secondary education at Fayetteville State University, majoring in psychology. During her sophomore year, she sought employment through a home health care agency, and suddenly died at her first day on the job, coincidentally four days after receiving the Gardasil vaccine.  Brooke Petkevicius (Florida) who was 19 when she died while at the University of California, Berkeley where she studied social work and was involved in many extracurricular activities including co-ed volleyball and ballroom dancing. She played on an intramural volleyball team, went to kickboxing classes. She also was a social welfare major. She died 14 days after her first dose of Gardasil from a pulmonary embolism or blood clot on March 26th, 2007. There is no family history of this. Brooke’s story: “Brooke did not smoke,” said her school friend, Megan Sedowski. “She was possibly one of the healthiest people I’ve ever met. She never did drugs and rarely drank alcohol. She worked out daily, and took a lot of classes at the gym. She never complained about anything, really, certainly not her health. She was an amazing, upbeat, caring, healthy young woman and her death was a complete shock.” Brooke had dressed to go running with a friend because they were training for a half-marathon. She walked to the elevator, collapsed against the wall and had a seizure. Brooke was rushed to the hospital and passed away. Brooke never had any problems with blood clots, nor did her family have any history of clotting problems. Subsequent tests of her younger sister and her mother showed nothing genetic. Brooke had no allergies, no tobacco use, and no past substance abuse problems. Drug tests came back negative. Cynthia Janak, who wrote this piece on Brooke, spoke to all her family. They told her what a wonderful, kind-hearted young woman she was. She had dreams and aspirations for her future and how her laughter was contagious and how her smile lit up a room. This was a girl who had it hard growing up, as many of us, but became a stronger person for it. The phrase Cynthia likes to use is “she took sour grapes and made fine wine.” (Email address: gzsrocks@yahoo.com)
Christina Richelle Tarsell (Sparks, Maryland). Chris was a girl on the go; a girl with a vision. She loved being at Bard College where she was an honor student. She loved studio art, philosophy, the tennis team, visits to New York City and hanging out with her caring, fun-loving friends. She was generous, compassionate and always gave back to others. Between her junior and senior years, Chris had a summer job working at the college art museum while living with classmates in a house in Tivoli, NY. So after a short visit home to Maryland, Chris returned to Bard and her job on June 13, 2008. During the visit home, on June 3rd, Chris had gotten her third shot of Gardasil. A few days later, Chris complained of feeling dizzy, tired and she developed a rash on her neck. She had a post-vaccine cough and sinus congestion that wouldn’t go away. We were never told of any side effects to Gardasil so we did not know these signs were significant. Chris was found dead in her bed 18 days after her third shot. What could have happened? Chris was always a healthy, wholesome girl, a non-smoker, an athlete. She didn’t take drugs or medication. As of this writing, the cause is “undetermined”. Further investigation suggests a link between the pulmonary edema, intraaveleor hemorrhages in the lung, the foamy, frothy fluids and the symptoms she was having as being immune related responses to Gardasil. Other Gardasil related deaths have similar findings of severe, lethal respiratory/inflammation problems. The CDC wants you to dismiss them as “coincidences,” while our beautiful, innocent daughters die needlessly. Doctors and researchers in the medical community agree that an autoimmune response like vasculitis could be triggered by this vaccine. (Email address: chriscares@live.com)  Amber Kaufman (St Louis, Missouri) was a perfectly healthy 16 year old teenage girl who collapsed on her way into work with a seizure and her heart then stopped. Amber played volleyball, track, bowled and loved hanging out with her boyfriend, family and friends. She was upbeat fun and loved life. She was the last in the nest, she was my best friend. She looked forward to joining the military like her older brother and sister. Her cause of death was listed as “cardiac disturbance of undetermined etiology.” Amber’s story – March 31st 2008, Amber went to the doctor for a sore throat and at the same time she was administered her second shot of Gardasil, she also had a shot of Rocephin and was put on Erythromycin (Z pack). Being her mom, I asked if she should have the shot since she was sick and her nurse practitioner said it would be no problem. She was also in the middle of her menstrual cycle when she received this shot. She stayed home from school a couple of days as she complained of headaches, being tired and slept a lot. I attributed it to her illness. She went to school on 4/3/08. Amber was on her way to work after school and I was on my way home, she called to let me know that the road to our house was closed due to water. That was the last time I ever talked to her, about 15 minutes later I got a call from her work saying she had collapsed on her way into work. I live only a few blocks from where she works. When I arrived they were just getting ready to start CPR. Amber was taken to the hospital about 15 minutes away; they did not get a heart beat until they reached the emergency room. She was transferred to St. Louis Children’s Hospital where she did not come off life support. Her brain had swelled and without a breathing tube or tube feeding she would not be able to live, she was brain dead. Amber was an organ donor on April 7, 2008. I sat at her head in the surgery room while they removed her breathing tube, she tried breathing for a while, I’m the one that had to tell her to go and to just be at peace and I was with her at the end. No mother should have to do that for her child, it was the hardest thing I have ever done or ever will do in my life! I am so glad my Amber saved at least five other lives. I get up every day because I know she would want me to let others know not to get this vaccine to prevent this from happening to any other young woman or mom. (Email address: teri6248@yahoo.com)  Megan Hild (Los Lunas, New Mexico) (died aged 20 in November 2008) Megan loved children especially her nieces and nephew. Her family was her life and she never missed an opportunity to spend time with them. She especially liked to be at home just hanging out with family and friends. Megan was a student at CNM working towards her Associates degree in radiology and general studies. Megan’s beautiful smile will be greatly missed by all who knew and loved her. She was a very healthy and happy young lady and loved going to college. Here is an excerpt of an email from her mother. On her death certificate it will read, Cause of death unknown. She’s my daughter and I loved her!!!! I will never see her graduate college. I will never see her wear a wedding dress and hold her babies in her arms. Megan’s autopsy report says two things “The pulmonary parenchyma is dark red-purple and the cut surfaces exude marked amount of blood and frothy fluid”. It should be noted that “frothy fluid” has appeared on another young woman’s autopsy report (see Chris Tarsall above) Her mother Karen adds this additional comment: “We have a sixteen year old son who says, “life does not matter, what you do in life does not matter”. This is how this vaccine has changed our family’s life forever! Megan was 20, happy and healthy. She was attending College with a promise of marriage after graduation. She held her life in the palm of her hand. Now all this family has is a certificate with an unexplained cause of death on it. Something that was to protect her health may have taken her life. There needs to be an investigation right away before more young women are injured, or worse, die. Please do not allow another family to have to live the life we have been made to live.” (email address: snowflakes18454@yahoo.com)  Well, I know for sure she made it to Heaven because the morning of her rosary, a hummingbird was inside our house. It let us catch it and when we released it, it looked at all three of us and flew straight up into the sky. She had to come to let her Mom know that she was okay. She died August 31, 2007 at the tender age of 18 years old. She just went to bed normally and never woke up. Autopsy and toxicology show nothing. Her heart and liver were a little enlarged. Death certificate says she died of natural causes but inconclusive due to toxicology and autopsy reports. Santana’s autopsy report did say that the pathologist had found the papillomatosis in her airways. Is there a possibility that Santana had Recurrent Respiratory Papillomatosis (RRP) which causes wart-like growths in the airway passages caused by the human papilloma virus? These growths usually form on the vocal folds, causing a voice disorder. Just before my daughter’s death I noticed strange breathing and a whistling noise which is very significant. If this condition had been there months earlier I would have noticed this change in my daughter’s breathing noises and even swallowing difficulties. However, this is not the case, I only noticed it after her Gardasil vaccination and before she died. (Email address: liliancrunk@hotmail.com)
Jessica Ericzon (Alexandria Bay, New York) (Died February 22, 2008 – age 17) I guess I will start with Jessie's first Doctor's visit where we went because of Jessie's acne. She had heard that sometimes birth control pills did wonders for acne. So in April of 2007 we went to the Family doctor. At this appointment she was put on the birth control pill Yazmin. Her Doctor did mention the Gardasil vaccine and what it was for, but they didn't push it at all. Jessie and I decided that we would take the pamphlet home and read it first, before we made a decision. On July 16, 2007 we went back to the Doctor for a re-check on her progress with the birth control pill and her acne which was clearing up quite nicely. We decided then to go ahead with her first Gardasil vaccination. I thought I was doing the best for Jessie, I mean who wouldn't want to do everything they could to prevent any kind of cancer when it came to their kids. Side effects were discussed and it was the usual nausea, fever, headache, same as if you were to get a flu shot. If I had known at the time that there was even the slightest chance of death, I would have never allowed Jess to have the shot. There were no side effects after her first shot. We went in on September 17, 2007 for her second vaccination. The only complaint that she had was that it hurt to get the shot. I'm not sure when Jessie started complaining about her head hurting, plus she was always tired and her joints ached. She even felt dizzy once in a while. I did write in my diary on October 23, 2007 that she complained of a very severe headache. She spoke once in awhile of a spot on the back of her head that bothered her. She felt like it was a tumor, but I felt nothing when I checked. On November 20, 2007 I took her to the same family Doctor who prescribed her 2 previous vaccinations to check on why she could be having these headaches. He felt nothing and said it may be due to stress that she is having headaches and she was to take some Tylenol when needed. At no point in this conversation did side effects and Gardasil come up, it didn't occur to me or obviously the Doctor that Gardasil could have anything to do with it. After that visit she was still tired and her joints still ached and a few headaches here and there, I attributed the joint ache to Cheerleading as she was a base and did a lot of lifting. In February 2008, 18th-24th, Jessie was on a winter break from school, but she did take Distance Learning Classes thru the local community college. A few days that week Jess went to her school to practice pitching for the upcoming softball season. She loved to pitch and practiced as much as she could. On February 20, about 5pm Jess had her 3rd Gardasil vaccination and everything was fine until the night before she died, when Jess and I were sitting on the couch playing a Sudoku game on her laptop, Jessie said the spot on the back of her head hurt again. I told her to take a couple of Tylenol and hopefully she would feel better in the morning. At 9pm I kissed her goodnight and told her I loved her and went to bed. My other half Tim and I work at the same hospital so we left at about 5:10 that Friday morning February 22, 2008 and Jess was sleeping as usual. When we got home from work around 3:20 pm, I found Jessie dead on the bathroom floor. The shock to my body and brain are nothing I ever want to experience again. Although I relive them everyday of my life now. I see the blue of her eyes which were open slightly as if she were watching me as I lay on the bathroom floor with her knowing there was nothing I could do for her. When the troopers showed up Tim said I did mention the fact that Jessie had the Gardasil vaccination although I don't remember. I do remember telling someone about the pain in the back of her head before she went to bed. The next morning the Medical Examiner, Dr Livingstone called me to tell me they found no reason for Jessie's death. He said she was dead before she hit the floor. I do remember telling him about the 3rd Gardasil vaccination she had just had not 2 days ago. He said that he had not heard of any negative findings with Gardasil. After that Tim went home (as we were staying with my dad across the road) and Googled Gardasil. The information that came up was devastating to me. I felt I had killed my daughter. I will stop here because the rest is basically much grief and much research. Respectfully, Lisa Ericzon. Lisa Ericzon would also like to add: “Losing your daughter at the age of 17 is indescribable. It is something that I will live with for the rest of my life. Knowing that it could have been prevented is a guilt I will carry also. Jessie was the All American teenager – happy, healthy, never did drugs or smoked. She was so full of everything life could offer her and did everything life would allow. She participated in all the sports and cheer leading in her school. Jess was an honor student and #8 in her class. I could go on and on because she was someone who I was ALWAYS proud to call my daughter. She was the best of the best and was on the road to becoming a success story in today’s world. Now she is gone and my life is empty without her.” “Gardasil killed my daughter Jessie and it is my hope that Gardasil will end soon, so no other family has to suffer with losing their daughter.” (Email address: laknights7@westelcom.com) European Gardasil Death  Jasmin Soriat (Germany) 04.14.1988 - 10.12.2007 The 19-year-old succumbed to respiratory paralysis after she was vaccinated against HPV. “She was fit, happy and fun-loving. She never had any serious illnesses, had no lung disease, and she never smoked. There were also previously never problems with vaccinations.” The last night Meticulously the parents have reconstructed the final hours of Jasmin: “She was at a concert a Spanish band, before midnight she was at a fast food restaurant, then drove with her flatmate home by taxi to Döbling. Two o’clock in the morning drank some tea. Her girlfriend came by to check up on her the next day but Jasmine, according to her friend who said, “She must have died a few hours earlier in her sleep.” (This was a rough translation from German) |
| Gardasil and Cervarix: Vaccine Or Villain, Blessing Or A Curse: Grave Concerns And The Need For Less Hype And More Serious Immediate Study And Testing. Though this may be unusual material for this blog; I am quite willing, given the substance of the concern to honor requests to spread the word here. (Ed.) http://cafecamuspoliticalcoffeehouse.blogspot.com/2009/07/gardasil-and-cervarix-vaccine-or.html And just a thought: Rush-In Roulette Can Be As Dangerous As Russian Roulette And A Question: Is Your Daughter A Guinea Pig For A Pharmaceutical Company? To the esteemed members of the Robert Koch Institute and Health Minister of Germany, The attached paper has been prepared by concerned individuals from the United Kingdom, United States of America and Holland in regards to the safety and efficacy of the HPV vaccines. We intend to prove that the serious health concerns that are becoming evident due to Gardasil and Cervarix around the world are valid. You will see that the studies themselves will prove the lack of efficacy and =he increased risks to the health of our young people. Also entered into his report are communications with the lead researcher for both Gardasil and Cervarix. Included are reports of young girls and women who have had serious adverse effects and deaths with unknown etiology from America and Europe. Attached is a video of Karen Maynor who lost her daughter after =receiving the Gardasil vaccination. This mother is trying to come to terms with the =act that the post mortem determination is unknown. We also want you to know that an inquiry was done by the researchers in the United States as to the overall health and activity level of the affected young people pre-vaccination. The results of the inquiry and investigation that ensued are startling. It has been determined that the young people most likely to be affected are very active, athletic and high achievers or have a serious weight problem. A subset of the affected received the vaccination when they were at the pre-menstrual time of their cycle. What these three groups have in common is that estrogen, which we know protects the brain from stroke, is decreased leaving the brain more susceptible to damage of the capillaries and the neurotoxin Aluminum. We are aware that you are questioning the effectiveness of Cervarix. Thousands of young girls and women are experiencing severe adverse events and their quality of life is vastly diminished around the world from Gardasil and Cervarix HPV vaccines. Could you please also look at the bigger picture in regards to the safety of our children and take into account the many comments which have been made. We do so hope you will read our submission and if you wish to ask any questions of the authors, email addresses have been provided. We do so hope that you will give serious consideration to our many concerns in regards to the safety and efficacy of both HPV vaccines. Sincerely, Cynthia Janak Research Journalist Founder & President International Coalition of Advocates for the people Leslie Botha Researcher and Broadcast Journalist Vice-President International Coalition of Advocates for the =people The Attachments: One Mother’s Plea By Leslie Botha & Cynthia Janak Karen Maynor of New Mexico lost her daughter, Megan Hild to the Gardasil vaccine on November 15, 2008. Megan was a healthy, vital 20-year-old young woman with great aspirations –and no history of previous medical problems. Megan had just finished the second in the series of the Gardasil vaccination in September of 2008. On November 15, Megan called her family’s home to let them know that she would be over later in the morning. That was the last that anyone heard from her. Days before Megan had complained of severe headaches (migraines) and stomach pains. Two hours later, Karen received a phone call from Megan’s fiancé that her daughter had died while taking a shower. When she arrived at Megan’s home along with the emergency units, Megan’s limbs were already blackened. It was estimated that she had been dead about 1½ to 2 hours before found. Although the initial autopsy report cited that cause of death was “unknown,” there was documentation of vaginal hemorrhaging, blood in the foamy fluid found in Megan’s mouth and nostrils that had come from the lungs. Ever since, Karen has been on a relentless pursuit of trying to understand why her daughter died so unexpectedly. She like, many other mothers in the United States have linked Gardasil to their daughter’s unexplained medical conditions and death. Karen has been in touch with her state senator to alert them of the Gardasil issue and the harm that it is doing to adolescent girls. Below is a copy of the letter sent to the New Mexico Department of Health. Dr Alfredo Vigil, Secretary New Mexico Department of Health 11901 South Saint Francis Drive Santa Fe, NM 87502 May 12, 2009 Dear Secretary Vigil: I was recently contacted by a constituent, Karen Maynor, concerned about the possible side effects of the vaccine against Human Papillomavirus (HPV), known as Gardasil. Unfortunately, her young daughter, Megan died from an unexplained cause of death a short time after having taken the vaccine. In trying to find some answers to Megan's death, Ms. Maynor discovered there have been several cases of unexplained deaths as well as incidents of paralysis, convulsions, and amyotrophic lateral sclerosis (ALS) in young women after taking the vaccine. It appears that the side effects have not been fully explored by the medical community. While there is no conclusive proof that the vaccine causes these conditions, her research has found that many members of the public are unaware that these serious conditions have been linked to the vaccine. Although the approval of drugs is done at the federal level, I encourage you and other health professionals in New Mexico to bring this issue to the public's attention and begin the dialogue that may encourage federal health agencies to investigate the possible consequences of vaccination. It is important that parents be told about possible risks before deciding whether to allow their children to be vaccinated. I stand ready to assist you in any way I can and look forward to working with you on this issue. Thank you for your consideration. Sincerely, Michael S. Sanchez Senate Majority Leader On May 19, 2009, the American Academy of Environmental Medicine issued this press advisory in regards to Genetically Modified Foods. If genetically modified food poses a serious enough health risk for the AAEM to issue this advisory, what kind of health risks can be associated with a Genetically Modified Vaccine? Wichita, KS - The American Academy of Environmental Medicine (AAEM) today released its position paper on Genetically Modified foods stating that "GM foods pose a serious health risk" and calling for a moratorium on GM foods. Citing several animal studies, the AAEM concludes "there is more than a casual association between GM foods and adverse health effects" and that "GM foods pose a serious health risk in the areas of toxicology, allergy and immune function, reproductive health, and metabolic, physiologic and genetic health."http://www.aaemonline.org/pressrelease.html We conclude this paper with a video of Karen Maynor on the day that she scattered Megan’s ashes in the mountains of Colorado, as she makes a plea to the Obama administration and to the world requesting officials investigate the Gardasil vaccine before there is any more unnecessary loss of life. http://www.youtube.com/watch?v=Kcpoqo_MNis&feature=email The Dutch Cervarix Concerns Annelies Witlam and Janny Stokvis The Netherlands We probably speak a different language than you do. Not only because we're Dutch, but also because we're not scientists, medical specialists or journalists. We consider ourselves professors in everyday life and even more, we're mothers. It was September 2008 when we first read an article about Gardasil. Meanwhile it has become a daily routine to read all the news (good and bad) about HPV, Gardasil and Cervarix. Although we had read enough about what was going on in the US we never expected to come in the middle of the same scenario in Holland. Media Reports 1. it’s not easy to express how it feels to experience how an entire population is misled. We see on TV “This vaccine (Cervarix) is safe and effective” “It is highly tested and it has only minor adverse reactions; it prevents cervical cancer.” A point of concern is that girls from the age of 12 are told they can get the vaccine without their parent’s permission. They are not old enough to drink alcohol, drive a car or vote, but they are allowed to make a decision about something of which they can’t perceive the consequences and yet can get a vaccination when they show their ID card. http://www.prikenbeschermdenhaag.nl/index.php?s=2&l=04 If we use common sense, then we can't find any other reason for this deception other than they don’t want us to know what the deal is with these HPV vaccines. A lot of people in The Netherlands do not believe in these beautiful stories, they do their own research and that resulted in heavy resistance against the vaccine. Show-up rate for the first shot was less than 49%.http://www.rivm.nl/cib/binaries/09%20HPV%20nieuws13_tcm92-59819.pdf 2. Nine weeks Cervarix in The Netherlands: Six girls hospitalized after vaccination, more that 700 acute incidents; 500 reported adverse reactions. (The data also can't be used to determine the frequency incidence, or known side-effects because they are often under-reported)http://www.rivm.nl/cib/themas/HPV-vaccinatie/#index_1 http://www.lareb.nl/kennis/signalen.asp. Adolescent girls are thinking they are protected against all cancers; girls thinking they don’t have to use condoms anymore. Girls thinking they'll never need to have pap smears. Parents who were thinking they were protecting their daughter, but now thinking they harmed her. There are parents and girls who have not been taken seriously by physicians when reporting adverse reactions. 3. Cervical Cancer and what the Dutch government says about it: Cervical cancer is the second most common cancer that afflicts women (after breast-cancer) worldwide. Every 18 minutes a woman dies of the disease. HPV is the most important cause of cervical-cancer. Over 70% of cervical cancers are caused by two dangerous HPV-strains, known as HPV-16 and HPV-18. Every year they’re about 600 cases and 200 to 250 women die of the disease. The Dutch Health Commission claims that these numbers can be decreased by 50% with the implementation of the HPV vaccination programme. Ministers of Health in different countries demand proof of severe adverse reactions; otherwise they consider the vaccines to be safe. We think it should be the other way around. The fact that adverse reactions are under-reported worldwide, that there hasn’t been proper investigation of the safety of the HPV vaccines should be a major concern. We think the following needs to happen. Stop all vaccinations with the HPV vaccines immediately. Start intensive independent research on the safety of the HPV vaccines and the adverse reactions. Improve the reporting systems on adverse reactions on vaccines and medicine. Let the reports be investigated by independent organisations. And give a voice to the girls and their parents, who suffer after vaccination. It’s an injustice that they have to live with the consequences and are not being heard. We'll show and prove what in fact is going wrong. The truth about Gardasil and Cervarix. There are 127 strains HPV. Gardasil may be protecting against two innocent strains and two dangerous strains 16 and 18. Cervarix may be protecting only the 16 and 18 strains. That leaves 123 strains of HPV left to cause cancer, genital warts, and autoimmune disease or eventually pass through the body. The question is will GSK and others keep developing vaccines to combat all of the other strains? The real number of HPV-strains that can cause cancer is apparently not clear. 4. Gardasil and Cervarix are not cancer-vaccines; Gardasil and Cervarix are virus-protectors. HPV-infection is very common. It's a sexual disease and 100% preventable. http://www.judicialwatch.org/story/2008/may/judicial-watch-investigates-side-effects-hpv-vaccine . It's the only preventable cancer in the world. Cervical cancer is not even on the top-10 of worldwide cancers. According to the FDA VRPBAC Background Document girls who already have a HPV-infection and take their HPV-shots are 44.6% more likely to get cervical-cancer because the vaccine contains the exact triggers for the vaccine to turn into cancer. Besides all this, we have to keep in mind, both vaccines are not proved, they are an experiment! It will take at least 10 or 15 years before we know whether the vaccine is working at all. The Centers For Disease Control and Prevention has received 9,749 complaints about Gardasil between June 8, 2006, and June 30, 2008. They range from headaches and fainting spells to blood clots and paralysis -- even death. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm111280.htm Post Article Largely Ignores Health Problems with Gardasil Vaccine By Erin Brown (Bio | Archive) A major pharmaceutical company lobbies to require that children be given a vaccine. Parents should be made aware of any problems resulting from the vaccine, right? Not according to a recent Washington Post article. Rob Stein’s March 26 article about the Gardasil vaccine debate failed to include any references to the several documented cases of health problems and even death that resulted from the vaccinations. His two-page article highlighted the tone of the Gardasil debate, reflecting the impact on young girls’ sex lives and the potential use for a male vaccine. But Stein barely touched on the concerns of critics that the vaccine actually caused health issues for young women. The Gardasil vaccine is a series of three shots offered to young women to significantly lower their risk of contracting the Human Papillomavirus (HPV), which can cause cervical cancer. Stein noted that “Critics worried that vaccinating children would send a subtle signal that their parents assumed they would become sexually active and that it would give youngsters a false sense of security.” True enough, but critics are also worried that this miracle vaccine may come with its own set of problems. The National Vaccine Information Center (NVIC) is one of those critics. According to the website NVIC is “the oldest and largest consumer organization advocating the institution of vaccine safety and informed consent protections in the mass vaccination system…” The mission of the NVIC is to prevent vaccine injuries and one of its targets is the Gardasil vaccine. According to a June 26, 2007 NVIC press release, “Nearly 90 percent of all Gardasil recipients and 85 percent of aluminum placebo recipients reported one or more adverse events within 15 days of vaccination, particularly at the injection site. Pain and swelling at injection site and fever occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.” The information in the press release was obtained from the vaccine’s maker, Merck, and the Food and Drug Administration, and it prompted NVIC to advise against recommending the “universal use of Merck’s Gardasil vaccine in all pre-adolescent girls” to the CDC's Advisory Committee on Immunization Practices (ACIP). A February 2009 NVIC report noted that there are at least 29 known cases in which young patients died after receiving the Gardasil vaccine,. “A 21-year old Maryland artist, athlete and honor roll college student died suddenly without explanation in June 2008 after her third Gardasil shot,” the article reported. “She is one of the 29 Gardasil death reports in VAERS.” VAERS is the Vaccine Adverse Events Reporting System. Stein did note concerns that the vaccine isn’t totally safe. Buried at the end of the article was this: “Federal health officials, Merck and others say they are confident that the vaccine is safe. But some experts said they are concerned that there is insufficient evidence about how long Gardasil's protection will last, whether serious side effects will emerge and whether the relatively modest benefits for boys are worth even the small risks associated with any vaccine.” Death is hardly a small risk, and NVIC’s very serious concerns should have been prominently featured in an article about the Gardasil controversy. Gardasil Death & Brain Damage: A National Tragedy http://vaccineawakening.blogspot.com/2009/02/gardasil-death-brain-damage-national.html The tragic story of Gardasil vaccine is one that is playing out real time in the homes of trusting parents, who thought they were doing the right thing to try to make their daughters "one less," and in the 21st century cyberspace forum of public opinion as well as on television. On Feb. 6,CBS-TV Evening News released NVIC's new report on Gardasil vaccine risks. (watch VIDEO here) United Kingdom Concerns Regarding HPV-GM Vaccines
The following points are the serious concerns of the above authors from the United Kingdom (representing Scotland and England) who have researched the Cervarix vaccine in depth. They have noted media concern over many young girls adversely affected by serious illnesses, such as several forms of paralysis including Bells palsy, hemiparesis, hypoaesthesis and Guillaine-Barre Syndrome. Convulsions, seizures and epileptic fits, along with diminished vision have also been cited. The UK Health Minister, Dawn Primaralo and Scottish Health Minister Shona Robison, deny that these illnesses are connected to the vaccine and that they are coincidental in nature. Please note that many of the adolescent girls in the UK, as well as their counterparts in America who are being vaccinated with the sister HPV vaccine Gardasil, report similar complaints and adverse events after inoculation. How can a causal relationship to the vaccine be denied? 1. Concerns about Cervarix Advert sent out to General Practitioners in September 2008 In September 2008 the GlaxoSmithKline (GSK) vaccination programme was implemented in the UK. Within the small print of the Cervarixpackage leaflet and GP Advert, GSK makes the following points: “There is no data on the use of Cervarix in subjects with impaired immune responsiveness;” “Duration of protection has not been fully established;” and “Timing and need of booster has not been investigated.” 1.1 GSK has admitted that research has not been conducted on impaired immune responsiveness How can this vaccine be recommended for young girls with a history of serious illness if research has not been carried out in this important area?School nurses will not have access to medical records, or have the experience or knowledge to advise the parents of young girls on this serious issue. Are parents aware of this lack of research in order that they can discuss their children’s history of illness with their doctors? What is implied is that GSK has no idea if a child with a serious health problem will be protected or adversely affected by the vaccine. 1.2 Girls on medication, reaction of vaccination Is a nurse qualified to know if a child who is on, for example, a steroid inhaler for asthma should be given the vaccination? As far as we know, no research has been carried out to identify any serious cross-reactions with the vaccine and prescribed medication. 1.3 Duration of protection not known - booster research has not been carried out as outlined by GSK Since parents are not informed of this information, they may not be aware that their children may only be protected for a short period of time, and since booster jabs were not being investigated then the actual vaccination may potentially be a waste of resources. This confirms the expert Dr Diane Harper's opinion, in Scotland on Sunday article of 2nd November 2008, that another four years of research should have been carried out before starting on this programme of vaccination. She actually described the scheme as “an experiment.” Dr Diane Harper considered insufficient research carried out, couldn’t guarantee 100% safety. 2. Age of vaccination in the UK –12 year old adolescent girls are given this vaccination 2.1 Alliance for Human Research Protection · Dr. Harper, a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire, said: "It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue." · "This vaccine has not been tested in little girls for efficacy.” · Harper, who was also a lead researcher in the development of the Human Papillomavirus vaccine, adamantly states that giving the drug to 11-year-old girls "is a great big public health experiment." 2.2 Dr Harper felt that there was insufficient evidence gathered on side effects to know that safety is not an issue. She also considers that given the propensity for young girls to still develop their neurological systems, it seems wise to wait until the girls are a bit older (email from Diane Harper of Tuesday, March 17, 2009 refers – can be forwarded if required) 3. Debate between UK Health Minister and Conservative MP, Mr Crispin Blunt, Wednesday 13th May 2009 3.1 Rebecca Ramagge referred to is constituent of Mr Blunt. Sunday Express · We would like to refer you to Column 992 – 4th paragraph where the Minister makes reference to the 1500 cases out of 1 million – she has made a serious error in her calculation, she states 0.0015% when in actual fact the correct calculation is 0.15% - she is out by a factor of100; · Column 992 – 5th paragraph – the same error as in para 4 above occurs yet again – the Minister refers to 0.00017% when this should be 0.017% - again a miscalculation by a factor of 100; · Second point in this paragraph and I quote her words “There is good reason to think that the reported symptoms were associated with an underlying condition or illness…” 3.2 In Cervical Cancer, 4th paragraph, Dr. Harper makes reference to a young girl named Jenny who died of rapid ALS and said “It could have been the straw that broke the camel’s back in a child who was already predisposed to the condition”, meaning that Jenny could have eventually developed the disease and the HPV vaccine accelerated the onset of ALS. This could also apply to any “underlying” conditions within a child in the UK and could be a time bomb waiting to be set off, as in the case of young Jenny above. It also should be noted that Dr Harper extends her concern in regards to a family history of auto-immune disorders which could be triggered by the HPV vaccine. It is sad that the UK Health Minister who cannot get her calculations correct also appears to accept that the reported symptoms were associated with underlying problems and yet has not said specifically “we should be alerting the medical authorities to this possibility”. 4. Former TV Star Jade Goody used to Encourage Girls to get Vaccinated 4.1 Before Jade died the Stockport Express used Jade in an advertising stunt to advertise and promote the Cervarix vaccine in their article called 'Jade Goody urges Stockport girls to get Cancer Jab'. This was exploitation. · Dr Baxter, the consultant in communicable disease control, who was interviewed admitted to not having the facts about Jade’s case; · Jade had advanced Cervical Cancer and was dying because she had not returned to the clinic, when requested, after a smear test turned out to be positive. Jade was used to advertise a vaccine by the very fact she was dying of Cervical Cancer; · Buxton Advertiser in March 2009 had an article entitled ‘Tragic Jade Goody leaves legacy of better cancer awareness’ and Guardian 'Jade Goody: celebrity's fatal illness changed cervical cancer attitudes. NB. It was a very sad situation for this young mum but had she returned to the Clinic when first approached, she may have stood a better chance of survival; · Cervarix would not have helped Jade in this situation as anyone who already has the HPV virus cannot be fully protected by the vaccine. Regular pap screening and attendance at follow-ups is the key. - as confirmed by Diane Harper, leading expert on the HPV vaccines Cervarix and Gardasil. 5. Is HPV an STD? It is generally thought that you can only get the HPV virus through sexual intercourse. This is a misconception. Numerous studies have shown that Human Papillomavirus can be contracted in many non-sexual ways, HPV Types 6 and 11 are sexually transmitted and so it has been generally thought that all HPV viruses are caught in this way. It has been fully established in several studies which you will find in www.pubmed.gov when you search for "HPV transmission vertical" which will support the points we are making. 5.1 In “Dying of Innocence” – Women are dying of cancer because medical research is not being shared, a question asked by Dorothy King, June 2005”, see link above. In this article many serious points are raised: · HPV vaccines need to be administered before women catch the HPV virus, so we need to know how and when papilloma is acquired; · Science has changed and studies have shown that Papilloma can be contracted in many non-sexual ways, but for some reason these studies are being ignored; · For example, among 52% of 3-11 year olds in a large study in South London had signs of exposure to HPV 16 infection; a similar 1995 study in China had 30% of newborns testing positive for HPV, as did another study in Colombia which recorded similar levels among primary school children; · Condoms do not prevent the spread of HPV – the bottom line is Papillomavirus is everywhere; · The Wellcome Trust, which gives money only to the most reputable researchers – has funded many studies that have yielded similar results. Cervical Cancer is the easiest cancer to detect, but women in the UK are still dying from it each year because we are not sharing and publicising research. Many of these women are dying because they did not get a smear test out of embarrassment or ignorance. If we can get the new research across we can make women realise that HPV is normal and encourage them to go for smear tests and, most importantly, highlight to them the dangers of ignoring a request to return to the Clinic for further examination – Jade Goody made that mistake and unfortunately she died. We would appreciate it if you could give consideration to the many points raised in our paper. We are aware that you are questioning the effectiveness of Cervarix but would appreciate it if you could also look at the whole picture to ensure the complete safety of our children. United States Concern For Europe With Regards To Cervarix HPV Vaccine. Authors: Cynthia Janak, Research Journalist, President of an International Coalition, Leslie Botha Researcher and Broadcast Journalist, Vice-President of an International Organization This paper will focus on four areas: (1) European Public Assessment Report, (26/11/2008 Cervarix-H-C-721-II-04), (2) Cervarix© Product Information (PI_Cervarix.pdf.), (3) MHRA (Medicines and Healthcare products Regulatory Agency) March, 2009 and May, 2009. (4) Media reports. (brackets my emphasis) Reports from around the world in regards to the HPV vaccines concern us greatly in the United States. Many of us have friends and family in Europe. We do not want to see any harm come to any citizen because of this kinship. That is why we felt it to be of paramount importance to add this information about the Cervarix © vaccine. (1) European Public Assessment Report 1.1 QUALITATIVE AND QUANTITATIVE COMPOSITION (page 2, title 2) “adsorbed on aluminium hydroxide, hydrated (Al(OH)3), L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived fromTrichoplusia ni.” 1. Contains 0.5 mg aluminum hydroxide 2. Trichoplusia ni (Hubner, 1800 – 1803) is nothing more than a Cabbage Looper Moth. The DNA from this moth is being used in the construction of the L1 protein. There have been no studies conducted in regards to effects of insect DNA interaction with human DNA mentioned in this report. 1.2 CLINICAL PARTICULARS (page 2 title 4) (4.1, second paragraph) “The indication is based on the demonstration of efficacy in women aged 15-25 years following vaccination with Cervarix and on the immunogenicity of the vaccine in girls and women aged 10-25 years.” Page 5, Clinical studies, paragraph 1 - The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years. Page 8, Bridging the efficacy of Cervarix from Young adult women to adolescents, paragraph 1 - In two clinical trials performed in girls and adolescents aged 10 to 14 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7) with GMTs at least 2-fold higher as compared to women aged 15 to 25 years. On the basis of these immunogenicity data, the efficacy of Cervarix is inferred from 10 to 14 years of age. (It is not mentioned in this report which clinical trial the 10 – 14 age group participated in and the number of participants for this age group.The length of the study is also not known. Efficacy in this age group is only inferred. This age group receiving this vaccine is not relevant if there is no statistical benefit.) 4.2, Page 11, paragraph 1, - The need for a booster dose has not been established Paragraph 2 - Girls aged less than 10 years: Cervarix is not recommended for use in girls below 10 years of age due to lack of data on safety and immunogenicity in this age-group. (The target age group to my knowledge is 9 – 26.) 4.4, Page 11 - Special warnings and precautions for use, paragraphs 4 and 5 - Vaccination is not a substitute for regular cervical screening or for precautions against exposure to HPV and sexually transmitted diseases. As with any vaccine, a protective immune response may not be elicited in all vaccinees. Cervarix protects against disease caused by HPV types 16 and 18. Other oncogenic HPV types can also cause cervical cancer and therefore routine cervical screening remains critically important and should follow local recommendations. (If cervical screening still remains critically important then the vaccine is of no statistical benefit because it does not address the whole issue.) Paragraph 8 - Duration of protection has not fully been established. Timing and need of booster dose(s) has not been investigated.(Duration of protection is unknown therefore making this vaccine statistically irrelevant with further costs probable.) 4.5, Interaction with other medicinal products and other forms of interaction, page 12 - Use with other vaccines – Data have not been generated on the concomitant administration of Cervarix and other vaccines. Use with hormonal contraceptive - In clinical efficacy studies, approximately 60% of women who received Cervarix used hormonal contraceptives. There is no evidence that the use of hormonal contraceptives has an impact on the efficacy of Cervarix. (Safety studies were not done in regards to the issue of hormonal contraceptives. This posses a real issue in regards to blood clot formation and this vaccine.) 4.8, Undesirable effects, page 12, paragraph 1, sentence 3 - In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection. (No long term study into the adverse events was mentioned in this report.) (2) Cervarix© Product Information 2.1 Page 14, paragraph 4 - As with any vaccine, a protective immune response may not be elicited in all vaccinees. (It is unknown what percentage of vaccinees are protected.) Page 14, Effects on Fertility - Fertility was not affected in female rats given double the clinical dose of CERVARIX by intramuscular administration 30 days prior to mating. Page 15 and 16, Genotoxicity - The genotoxic potential of CERVARIX has not been investigated. The adjuvant substance MPL has been tested for genotoxicity in a series of in vitro assays (bacterial mutation and chromosomal aberration) and an in vivo rat micronucleus test. Under the condition of these assays, MPL did not cause genetic damage. Carcinogenicity - The carcinogenic potential of CERVARIX has not been investigated. Ability to perform tasks that require judgment, motor or cognitive skills - No studies on the effects on the ability to drive or use machines have been performed. 2.2 (Adverse events not documented in a concise, detailed table format. Unable to determine percentage of participants affected with an adverse reaction to this vaccine. Potential population numbers as to this issue is not attainable making this vaccine a potential safety issue.) (3) MHRA (Medicines and Healthcare products Regulatory Agency) - Summary of UK Safety Experience 3.1 – March 2009. Total number of reports received: 1,340. Total number of suspected reactions: 2,891 (reports received between April 14, 2008 and March 4, 2009.) [PDF. Attached] 1. Injection-site reactions: Total reactions – 418; Total reports – 312. These may occur at a frequency of more than 1 in 10 persons vaccinated. 2. Allergic reactions (including skin reactions not directly related to an injection-site reaction): Total reactions – 259; Total reports – 156. These may occur at a frequency between 1 in 10 persons (for non-serious types of allergic reactions such as rash and itching) to less than 1 in 10,000 persons vaccinated. 3. ‘Psychogenic’ events: Total reactions – 851; Total reports – 330. Such events can be associated with a wide range of temporary signs and symptoms including loss of consciousness, vision disturbance, injury, limb jerking (often misinterpreted as seizure/convulsion), limb numbness or tingling, difficulty in breathing, hyperventilation, etc. 4. “Other recognized” reactions: Total reactions – 1125; Total reports – 626. This section includes other events recognized to be side-effects of Cervarix vaccine. 5. Suspected adverse reactions not currently recognized: Total reactions – 238; Total reports – 153. These suspected ADRs are not currently recognized as side effects of Cervarix vaccine. 3.2 – May 2009. Total number of reports received: 1,710, total number of suspected reactions: 3,774 (reports received between April 14, 2008 and May 21, 2009.) [PDF. Attached] 1. Injection- site reactions: Total reactions – 591; Total reports – 430. 2. Allergic reactions: Total reactions – 347; Total reports – 210. 3. ‘Psychogenic’ events: Total reactions – 999; Total reports – 382. 4. “Other recognized” reactions: Total reactions – 1418; Total reports – 765. 5. Suspected adverse reactions: Total reactions – 419; Total reports – 243. It is important that you refer to the documents attached to get a comprehensive overview of all the symptoms they consider to be ‘Psychogenic’, ‘Other recognized’ and Suspected events. All reactions stated in these reports are the same reactions that are being reported in the United States. Treatise On Gardasil From The United States Authors: Cynthia Janak, Research Journalist, President of an International Coalition, Leslie Botha Researcher and Broadcast Journalist, Vice-President of an International Organization, H. Sandra Chevalier-Batik, Research Analyst This paper will focus on five areas: (1) Compromised immune systems in adolescents and potential vaccine reaction; (2) Exposure of HPV to infants and children prior to inoculation; raising concern that the vaccine will be rendered ineffective (Botha); (3) Examination of FDA documents regarding adverse events and efficacy. Neurological affects of Aluminum (Janak); (4) The fast tracking of Gardasil through the FDA without due scientific process and adequate research (Janak); (5) The pharmaceutical industry in the United States has systematically influenced the regulatory agencies and research facilities to fast track drug trials and manipulated their outcome. (Chevalier-Batik) As of January 2009, the Vaccine Adverse Reporting System (VAERS) cites 43 deaths and 15,000 reported adverse reactions to the Gardasil vaccination since its introduction to the United States market in 2006. According to Barb Loe Fisher, director of the National Vaccine Information Center NVIC, only 1% of deaths and adverse reactions are being reported. In the FDA document, New Medical Conditions Reported in Subjects through Final Close-out data in studies HPV-007, 013, 015, 016, and 018, 73.3% participants in the Gardasil group experienced new medical conditions within 1 to 15 days after receiving the HPV vaccination. The potential magnitude of unreported deaths and injury not only in the U.S. but worldwide is of great concern. (1) Compromised immune systems in adolescents and potential vaccine reaction. 1.2 According to a 2008 Medscape.com article the authors state: “Unfortunately, baseline disease incidences are not established for most diseases, and country, ethnic, and age-group specific incidences are largely lacking. Consequently, it will be difficult to monitor globally the impact or to demonstrate the lack of impact-of a large-scale immunization program on the incidence of autoimmune conditions.” 1.3 On the CDC web site on HPV Vaccine Information for Clinicians, it is stated that: “Cervical cancer disproportionately affects women of lower socioeconomic status, without regular access to health care, who are uninsured, and who are recent immigrants.” If this demographic of women is at high risk for cervical cancer, it also stands that they are also more susceptible to lowered immune response and a higher incidence of autoimmune disorders. 1.4 Therefore we feel that adequate immune testing should be done, or evaluated by a woman’s physician prior to vaccination. Based on the above, if an AD already exists and the HPV vaccine is administered without regard to the condition, the potential adverse AD reactions will only diminish the safety of a woman’s health and skew vaccine efficacy outcomes. (2) Exposure of HPV to infants and children prior to inoculation; raising concern that the vaccine will be rendered ineffective 2.1 In a September 12, 2008 news release, the FDA stated that: “There was no evidence for benefit among women found to have been previously infected, prior to immunization, with the HPV types included in the vaccine. Therefore, to receive Gardasil’s full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine.” In an article written by Cindy Bevington, of KPC News, titled, “Researcher, Diane Harper Blasts Gardasil HPV Marketing,” she cites that Dr. Harper, a lead researcher in the development of the HPV vaccine, believes that prior to their first inoculation of the vaccine, adolescent girls “should be tested for the presence of HPV in their system.” 2.2 In a 1998, study on the Transmission of Cervical Cancer-Associated Human Papilloma Viruses from Mother to Child, posted on the Interviology, Karger.com web site, the authors stated that: “…HPV has been detected in asymptomatic women, infants and children. Several studies have demonstrated that infants can acquire high-risk HPV infections from their mothers at birth. Thus, the traditional view that cervical-cancer associated HPV infections are primarily sexually transmitted needs to be re-assessed. …the role of mother to child transmission of cancer-associated HPVs may need to be investigated further. These facts are pertinent to those developing prophylactic vaccines to prevent high-risk HPV infections and cervical carcinoma.” 2.3 The American Social Health Association (ASHA) cites that in a 1997 article in the American Journal of Medicine, about 74 percent of Americans--nearly three out of four--have been infected with genital HPV at some point in their lives. Among those ages 15-49, only one in four Americans has not had a genital HPV infection. Most often genital HPV produces no symptoms or illness, and so a person who has been infected may never know about it. 2.4 In the VRBPAC Background Document, May 16, 2008 “Future l & ll Study Female subjects 16-23 years of age with normal baseline pelvic examinations were eligible for enrollment and were not prescreened for HPV prior to randomization.” 8 Concerns Regarding Primary Endpoint Analyses among Subgroups cited that “there were two important concerns identified during the course of the efficacy review. One was the potential for Gardasil™ to enhance disease among a subgroup of subjects who had evidence of persistent infection with vaccine-relevant HPV types at baseline. The other concern was the observations of CIN 2/3 or worse cases –44.6% due to HPV types not contained in the vaccine. These cases of disease due to other HPV types have the potential to counter the efficacy results of Gardasil™ for the HPV types contained in the vaccine.” (3) Examination of FDA documents regarding adverse events and efficacy. Neurological Affects of Aluminum I do not find this to be surprising to me because of the information presented in the studies that I have found during my research. I am going to reference the documents that were presented to the FDA (Food & Drug Administration) here in the United States. (Underscore added for emphasis) 3.1 VRBPAC Background Document ,Gardasil™ HPV Quadrivalent Vaccine ,May 18, 2006 VRBPAC Meeting Page 2, paragraph 1 – 2002 CBER (Center for Biologics Evaluation and Research, FDA) “CBER granted fast track designation to Merck’s development program for the HPV quadrivalent vaccine for prevention of cervical cancer. Merck initiated phase 3 clinical trials of the HPV quadrivalent vaccine.” Page 13, Title: “Concerns Regarding Primary Endpoint Analyses among Subgroups, 1. Evaluation of the potential of Gardasil™ to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination.” “The results of exploratory subgroup analyses for study 013 suggested a concern that subjects who were seropositive and PCR-positive for the vaccine-relevant HPV types had a greater number of CIN 2/3 or worse cases as demonstrated in the following table:” Table 17 shows that the efficacy rate for anyone who were seropositive and PCR positive for vaccine related HPV types to be -44.6%. Page 14, Table 19, “Study 013: Analysis of efficacy against vaccine-relevant HPV types CIN 2/3 or worse among subjects who were PCR positiveand/or seropositive for the relevant HPV type at day 1.” Table 19 shows that the efficacy rate for this group to be -33.7%. Page 22, Table 32. “Detailed Safety Population: Number (%) of subjects who reported systemic adverse reactions of 2% or greater in the 15 days following receipt of study vaccine.” Table 32 shows that the number of subjects reporting systemic adverse reactions was 3591. That is a percentage of 59.2% of the participants. 3.2 June 8, 2006, Subject: Clinical Review of Biologics License Application for Human Papillomavirus 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae) (STN 125126 GARDASIL), manufactured by Merck, Inc. Page 321, Title: Systemic AEs (Days 1-15 after any vaccination) Page 322, Table: 237, Protocol 018: Number (%) of Subjects with Systemic AEs, Days 1-15 After Any Vaccination Visit “Number (%) with systemic AE = 541 (46.4%)” At this point I want to bring to your attention page 45, table 24, Study protocol 018. This group is the 9 – 15 year old group of boys and girls. 615 girls and 564 boys were in this study. This study also used a carrier solution as the placebo as evidenced on page 301, table 210. If you go to page 318, Table 232, Protocol 018 - Clinical Adverse Experience Summary, Days 1-15 Postvaccination by Age you will find: N (%) with 1+AE = 9 – 12 years of age, 567 (83.0%), 13 – 15 years of age, 396 (82.2%) under the column HPV vaccine. Page 368, “Title: Efficacy Conclusions, paragraph 2, sentence 2, In subjects who have been previously infected with a specific vaccine HPV type, there is no evidence of efficacy in reducing cervical dysplasia associated with that vaccine type.” Protocol 018 is the target age group for the HPV vaccines. This is why it is of no surprise to me that we are having so many adverse events being reported. I want to finish with the fact that 83.0% of this age group had an adverse reaction to the HPV vaccine and the fact that if a subject has been exposed to a specific vaccine HPV type there is no efficacy, then why would you consider vaccinating this age group or any age group for that matter. The truth is in the numbers and these HPV vaccines cannot be justified. It is my opinion that they will only increase the number of young people with new medical conditions after receiving a HPV vaccination. (I have seen similar results with the reports that I am receiving in regards to the Cervarix HPV vaccine.) 3.3 Neurological Effects of Aluminum Mineral and metal neurotoxicology, By Masayuki Yasui, Kiichiro Ota, M. Anthony Verity, Michael J. Strong, Edition: illustrated, Published by CRC Press, 1996, ISBN 0849376645, 9780849376641 Page 130, 13.3.2, Acute Aluminum Neurotoxicity, Paragraph 2, Sentence 6, “Although the patient may have mild neurological findings of aluminum neurotoxicity such as speech disturbance, more commonly there is an acute explosive onset of symptoms. The major findings in adults include confusion, myoclonic jerks, agitation, grand mal seizures, obtundatuion, coma and death.” Page 131, Paragraph 1, “The neurotoxicity in children… is somewhat different from that seen in adults. The disease is more insidious in onset and characterized by intellectual impairment, seizures, and regression of verbal and motor skills. This is exemplified by the finding that children who have just started to walk and talk may lose these skills. The frequency of seizures in children is equal to or even greater than that found in adults with acute aluminum intoxication.” I want to bring you back to the FDA document dated June 8th, 2006, page 393, Table 302, New Medical Conditions Day 1 through Month 7. Table 302 states under the Gardasil column, “Subjects with new medical history = 5842 (49.6%)”. The conditions mentioned in the above book are the same as what we are experiencing in the United States in regards to the HPV vaccine. It is my belief, per the work of Dr. Andrew Moulden, BA, MA, PhD, MD., that the watershed areas of the body including in the brain are affected in the fact that the severe immune response and the aluminum adjuvant (225mg-Gardasil, 500mg-Cervarix) is causing blockage of the capillaries throughout the body and the brain. The proof is in the stroke like symptoms that are evident in the girls and women who have suffered severe neurological adverse reactions from the Gardasil vaccination. (4) The fast tracking of Gardasil through the FDA without due scientific process and adequate research 4.1 VRBPAC Background Document, Gardasil™ HPV Quadrivalent Vaccine ,May 18, 2006 VRBPAC Meeting 2000 Submission of the original IND for the quadrivalent VLP vaccine containing the L1 protein from HPV types 6, 11, 16, and 18. Additional phase 1, phase 2, and phase 3 studies were conducted under this IND. 2005 May: Pre-BLA meeting. CBER agreed that the efficacy data limited to the first 24 weeks of the phase 3 studies could be submitted to the BLA in order to support efficacy. CBER encouraged early (rolling) submission of CMC, pre-clinical and phase 1 and 2 clinical data. CBER agreed to grant a priority review of the BLA. 4.2 Subject: Clinical Review of Biologics License Application for Human Papillomavirus, 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae) , (STN 125126 GARDASIL), manufactured by Merck, Inc. Page 45, Table 24, Quadrivalent HPV 6, 11, 16, 18 L1 VLP Vaccine Summary of Pivotal Phase IIb-III Trials (Study Protocol, Dates only) 007 – 06 05/26/00 – 05/10/04 4 years 013 – 04 12/28/01 – 7/15/05 3.7 years 011 – 03 12/28/01 – 06/11/04 2.6 years 012 – 03 05/30/02 – 06/30/04 2.1 years 015 – 04 06/24/02 – 06/10/05 3 years (ongoing for additional follow-up) 016 – 03 12/07/02 – 09/20/04 1.10 years 018 10/08/03 – 1/19/05 1.2 years Study protocol 018, 1650 participants, was the only protocol solely for the 9 – 15 year old age group which lasted just 1.2 years. This entire study segment only lasted 4.6 years which is not enough time to evaluate the long term effects of this new genetically modified vaccine. 1.2 years is not enough time to evaluate the adverse effects and long term safety in this group which this vaccine is being presently administered. Because of this we do not believe that adequate safety and efficacy data has been presented to warrant the continuation of administering this vaccine. (5) The pharmaceutical industry in the United States has systematically influenced the regulatory agencies and research facilities to fast track drug trials and manipulated their outcome. It would be far simpler if there were clear, direct, and explicit violations, but the people and organizations involved are too sophisticated and versed in the process to ever make such a blunder. All of the activities documented are, strictly speaking, legal. Taken in isolation they are not that onerous, yet in combination, they present a picture of willful deception, and a pattern of behavior that pushes the boundaries of what is legal and ethical - even to the point of writing and sponsoring new legislation extending those very boundaries. Have country’s decisions about the HPV vaccine been scientifically compromised and influenced by marketing? 5.1 In 1992, faced with protests by AIDS activists about the FDA’s glacier-like approval of potential life saving drugs, President George H. Bush signed the Prescription Drug User Fee Act (PDUFA) and changed the FDA drug approval process. PDUFA allowed pharmaceutical companies to “fast track” drug approvals by absorbing the extra costs involved. PDUFA, brought new resources to the agency aimed at decreasing the time FDA took to approve new drugs and license new biological products (e.g., vaccines), more quickly. The unintended consequence of this humanitarian intention became “Safety for Sale”, as evidenced by the number of product recalls in the past 15-years. Criticism of the current PDUFA process fits into three categories: 1. Fees have not fully covered FDA’s increased costs, despite increased Congressional funding; 2. PDUFA has directed a majority of the collected fees toward pre-market review of applications, in contrast to post-market surveillance and safety enforcement; 3. Keeping PHARMA’s inclination of ‘profit over accountability’ in check is a daunting task. Some critics think that, through its provision of fees, the industry has too much influence over FDA actions; with that some wonder if safety is being sacrificed for expediency 5.2 Archived documents discovered at the U.S. Food and Drug Administration's website reveal the agency knew in 2003 that HPV infections did not cause cervical cancer. Despite that knowledge, the FDA has continued to support the use of the Gardasil vaccine in compulsory vaccinations programs like the one announced in Texas. The FDA's own press release from 2003 admits that, "Most women who become infected with HPV are able to eradicate the virus [without intervention] and suffer no apparent long-term consequences to their health... most infections are short-lived and not associated with cervical cancer." (Source: "FDA Approves Expanded Use of HPV Test," March 31, 2003, www.FDA.gov) http://holyhormones.com/puberty/fda-approves-expanded-use-of-hpv-test/ 5.3 In 1980, the Bayh-Dole Act was created, which allowed academic settings to profit from their discoveries that were performed for pharmaceutical companies. This resulted in the creation of for-profit sites, called Contract Research Organizations (CROs), which are composed of community research sites with questionable investigators void of necessary experience or quality regarding their research purpose and ability. Since they are for-profit, the trials conducted at CROs are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsor’s medication. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit the collusive relationship between the site and the sponsor. 5.4 The pharmaceutical industry has been extremely successful in influencing the medical establishment. For example: - Individual physicians through sales people, freebies, CME, and consulting arrangements - Peer-reviewed journals through company-funded research, ghostwriters, subscriptions, and mass reprint buys - Guideline-writing groups through grants and the tools mentioned above Now, Swedish anti-corruption agents are investigating allegations that pharmaceutical giant AstraZeneca influenced the awarding of this year’s Nobel Prize in medicine. Numerous ties, both in money and influence were found between the pharmaceutical company and the Nobel selection committees. Part of the Nobel Prize in Physiology or Medicine was awarded to a German scientist who discovered the links between human papilloma viruses and cervical cancer. The discovery could be a financial bonanza for AstraZeneca. 5.5 Merck published a fake journal. Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products--that appeared to act solely as marketing tools with no disclosure of company sponsorship. 5.6 Documents were found describing Merck compensating investigators with honoraria for agreeing to serve as authors on review manuscripts ghostwritten on their behalf by medical publishing companies. Honoraria varied, ranging from $750 to $2500. S3W-25259 - Mary Scanlon (Highlands and Islands) (Con) (Date Lodged Thursday, June 25, 2009): To ask the Scottish Executive what measures are taken to establish whether young women already have the human papilloma virus (HPV) prior to the administration of the vaccine.
Title: High Prevalence Of Human Papillomavirus Type 16 Infection Among Children Infection with high-risk human papillomaviruses (HPV) is the most significant risk factor for cervical cancer and it may be possible to prevent this malignancy by immunisation. Before immunisation programmes can be designed, however, it is necessary to know the age of acquisition and all routes of infection for these viruses. Sexual transmission is well documented and vertical transmission has also been demonstrated, although the frequency of transmission remains controversial. We previously showed that vertical transmission frequently results in persistent infection, and now present data on the prevalence of HPV-16 DNA (the most prevalent high-risk HPV type) in healthy children. Buccal samples from 267 healthy children aged 3-11 years were tested for HPV DNA by generic PCR and a HPV-16 specific nested PCR. Reverse transcriptase (RT)-PCR was used to determine the prevalence of transcriptionally active HPV-16 infection in a subset of children. HPV-16 DNA was detected by nested PCR in 138 of 267 (51.7%) samples, whereas HPV DNA was detected in only 45 (16.8%) specimens by generic PCR, that has a lower analytical sensitivity. ……………” These three papers by researchers at King’s College spell it out so clearly that infection can be found in young girls – buccal samples from 267 healthy children aged 3-11 were tested and HPV-16 DNA was detected in 138 of 267 (51.7%) samples but what is so important and which has been ignored by both Governments in the UK is the phrase “Before immunisation programmes can be designed, however, it is necessary to know the age of acquisition and all routes of infection for these viruses”. This has not been done by either Government. NB This has been totally ignored, they have put our children at great risk as if HPV 16 is present in a young person then she will receive no protection from the vaccine – that is factual. However, it can be even more serious than that because if a person or child has tested positive or is positive for one of the HPV types in the vaccine at the time of vaccination they have an increased risk of 44.6% of having cervical cancer from one of the HPV types in the vaccine later in life. In essence this vaccine could be a cancer promoter. (See table and other links at end which will confirm these facts). The fact that no screening has taken place in Scotland prior to the vaccination programme only goes to highlight the seriousness of this and also how rushed this programme of vaccination was introduced by the Scottish Government without the careful checking of all of the facts. This piece of research in itself is sufficient to put fear in the hearts of the mothers and fathers in this country as they do not know if their daughters are safe.The Scottish Government cannot now guarantee this as the evidence is there for all to see which was prepared by eminent scientists at King’s College, London. The fear for this major error should now be with the Scottish Government, the Health Minister and the Cabinet Secretary as they just did not do their homework. This fear has to be sent to the House of Commons and opposition parties should be very angry that every avenue was not investigated by the Government to make sure that our children were kept safe. Unfortunately, this now cannot be guaranteed. Journal Link http://www3.interscience.wiley.com/journal/106056791/abstract Same problem occurring to do with cookies – going direct into the Journal reference brings up the paper. Journal of Medical Virology, Vol 71 issue 4, pages 593-598. Christine Mant, Barbara Keel, Philip Rice, Jennifer M Best, Jon M Bible, John Cason Title: Buccal exposure to human papillomavirus type 16 is a common yet transitory event of childhood High-risk human papillomaviruses, such as type 16 (HPV-16), are established etiological agents for cervical carcinoma. In most cases, this virus is transmitted sexually, though can also be spread from mother to infant at delivery. We have demonstrated previously a high prevalence (
Title: Transmission Of Cervical Cancer – Associated Human Papilloma Viruses From Mother To Child. There is now compelling evidence that persistent infection with certain types of human genital papillomaviruses (HPV) may, after many years, lead to cervical cancer. However, HPV have been detected in asymptomatic women, infants and children. Several studies have demonstrated that infants can acquire high-risk HPV infections from their mothers at birth. Thus, the traditional view that cervical-cancer associated HPV infections are primarily sexually transmitted needs to be re-assessed. Accordingly, the role of mother to child transmission of cancer-associated HPVs may need to be investigated further. These facts are pertinent to those developing prophylactic vaccines to prevent high-risk HPV infections and cervical carcinoma. Wish to refer you to Intervirology 1998; 41:213-218 (Dept of Virology, King’s College, London – have marked relevant sections for you to see. In a study of 350 London schoolchildren aged 1 through 11 years – to date; of 208 children tested 48% were positive when tested by a highly sensitive PCR. Together these data indicate that exposure to and infection with HPV-16 are relatively common in childhood (page 215 refers); it is a known fact that mothers can pass on this virus during birth and this paper says “HPV infection acquired before the infant’s immune system is mature may lead to immunological tolerance. This could permit persistence of such infections and/or a reduced ability to clear subsequent high-risk HPV re-infections in later life. Thus high risk HPV infections at birth have significant implications for the design of, and timing of the delivery of vaccines against genital HPV. (Mary has a full copy of this paper with relevant marked sections)
Title: Vertical Transmission of the Human Papillomavirus: asystematic quantitative review Many studies carried out on the risk of babies being born to mothers with positive HP Virus and tables indicating the positive and the negative results. The review finished with this “The critical question is not how often infants are contaminated with HPV, but how often they are infected with HPV.” “More studies with better methodological quality, longer follow up, and HPV testing by DNA sequencing in this area are needed.”
Title: Sexual And Non-Sexual Transmission Of Human Papillomavirus – A Short Review This reference I am going to send separately as a pdf file – it didn’t copy too well. It has just been received from a Hungarian Researcher and has a lot of valuable information which is highly relevant as it gives percentages of rates of infection and age groups which were tested and identifies the strain which was being investigated, HPV 16 which is one of the strains within Cervarix – very similar to the King’s College article above. Benign tumors and lesions of the anogenital tract are caused by human papillomaviruses (HPVs). They are also major risk factors for cervical cancer. Introduction of the polymerase chain reaction (PCR) revealed that HPV infections are much more common among young asymptomatic women than it had been previously suspected. The side-specificity of genital HPVs led to the assumption that HPVs were primarily transmitted by sexual contact. However, since HPVs have been detected in virgins, infants/children and juvenile largyngeal papillomatosis was shown to be caused by these viruses, it became acknowledged that HPVs may be transmitted by other – non-sexual – routes as well. The evidence for sexual and different non-sexual routes of transmission of HPVs will be reviewed here. Page 4 – Genital HPV Infection of Children PCR studies have indicated that the prevalence of HPV type 16 DNA in the buccal cavity of children may range from 0.25% – 52% - 17% in vulval swabs. HPV 16 DNA was detected in buccal swabs of 3-11 year old children in 52% using nested PCR ………. Enzyme immunoassay (EIA’s) – with different HPV16 peptides, fusion proteins – has shown seroprevalence of between 4% - 44% among children 0 – 13 years of age. ****************************************** NB – additional information relating to first King’s College paper identified in this report (This is information taken from the official American Food and Drug Administration (FDA) document regarding Gardasil – the information contained in the reference below is not about Gardasil per se but refers to the problems which could occur if an infected girl is vaccinated with the same virus type, eg HPV type 16 which is contained in Cervarix and Gardasil and from the information contained in this report it appears that these young girls could end up getting cervical cancer because they received the vaccine on top of having the infection). http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf - see also page 13, Table 17 – “Evaluation of the potential of Gardasil to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination” (This concern applies to Cervarix too) Page 168 of the June 8th, 2006 FDA document. Exploratory Analysis of Efficacy in subjects who were seropositive and PCR positive for vaccine HPV type related CIN • In subjects who were seropositive and PCR positive at baseline, the point estimate of vaccine efficacy for this endpoint was below zero (-12.5%), TABLE 110 Protocol 013: Analysis of Efficacy Against Vaccine HPV Type Related CIN Among Subjects who were PCR Positive and Seropositive for the Relevant Vaccine HPV Type at Day 1
Reviewer Comment: -- There are admitted difficulties with such subgroup analyses. For example, the resulting subgroup for each treatment arm may not have comparable baseline characteristics. Thus, CBER requested additional information on the baseline characteristics in each treatment group for subjects who were PCR (+) and sero (+) and who developed CIN 2/3 or worse due to the respective HPV type. Freda Birrell Grace Filby BA(Hons) Cert Ed FRSA 4th July 2009 | www.i-c-a-p.org Gardasil Side Effects and Injuries - Free Case Review by our Gardasil Lawyers and Attorneys. Keywords: Gardasil | Lawyer | Injury | Side Effects | Attorney | Blood Clots | Lawsuit | Miscarriage | Death The lawyers and attorneys at our firm are investigating instances of serious side effects linked to Gardasil, an HPV vaccine, including blood clots and deaths. Since Gardasil was approved by the Food & Drug Administration (FDA), its maker, Merck Inc., has undertaken an aggressive campaign to force families to subject their daughters to the Gardasil vaccine. And even thought Gardasil side effect reports are increasing, the FDA has refused to review the safety of this vaccine. Our Gardasil side effect lawyers are offering free consultations to anyone who suffered serious complications from Gardasil or their families. The Gardasil side effect lawyers at our firm will work hard to make sure Gardasil victims receive the compensation they deserve. Gardasil was approved by the FDA in June 2006. At the time of its approval, Merck & Co., the maker of Gardasil, said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers. The investigation conducted by our Gardasil side effect lawyers has concluded that the FDA erred in its rush to approve Gardasil, and did not study the vaccine's possible side effects thoroughly. The Gardasil side effect lawyer at our firm is disturbed at Merck's attempts to force Gardasil vaccines on your women. Following its approval, the Centers for Disease Control (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Recently, 20 states pushed for federal mandates to make Gardasil mandatory for sixth grade girls Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market. Gardasil Linked to Blood Clots, Miscarriages and Deaths Since its approval, Merck has claimed that Gardasil is practically side effect free, with pain at the injection site being the most common complaint about the vaccine. However, a 2007 Judicial Watch analysis of the FDA’s Vaccine Adverse Event Reporting System reveals that Gardasil has not been as side effect free as Merck claims. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency. Since its approval, there have been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. Other side effects including paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Our Gardasil side effect attorneys believe that even these Gardasil adverse event reports could be underestimating the true number of serious Gardisil side effect incidents that have actually occurred. For that reason, we are seeking to speak with anyone who experienced serious Gardasil side effects. Gardasil has also been linked to an increased instance of fainting following administration of the vaccine. From 2002-2004 there were a total of about 50 reports of vaccine-related fainting. But from 2005 until last July, reports of vaccine-related fainting spiked to about 230. About 180 of those cases followed a shot of Gardasil, according to the CDC). The Gardasil side effect reports also include 28 women who miscarried after receiving Gardasil. In May 2007, a 24-year-old woman suffered a miscarriage, which an investigator in a report issued to the federal government said, “may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy.” In July 2007, a 17-year-old girl from Texas was unaware she was pregnant when she got her second dose of Gardasil. She miscarried, but the cause of the miscarriage hasn’t been determined, according to a report. The reasons for two other miscarriages in Florida in 2007 - one by a 16-year-old and another by a 24-year-old both - are undetermined, according to reports. But it is known that both women had Gardasil vaccinations shortly before the miscarriages. If you or someone you know suffered a miscarriage following the administration of Gardasil, it is important that you contact one of our Gardasil side effect lawyers in order to protect your rights. Most disturbing among the Gardasil side effect reports are those that involve the deaths of young women. Three young women in the US died shortly after receiving Gardasil, while two other women in Europe also died after the vaccine was administered. Despite all of these reports, Merck continues to market Gardasil as virtually side-effect free. Our Gardasil side effect lawyers believe that Merck has misled the public about Gardasil's potential dangers, and our law firm intends to hold Merck accountable for these dangerous Gardasil side effects. Legal Help for Gardasil Side Effect Victims If you or someone you know suffered a serious Gardasil side effect, you have valuable legal rights. Please fill out our online form or call as at 1-800 LAW INFO (1-800-529-4636) to speak with a qualified Gardasil side effect lawyer. CDC Takes Closer Look at Gardasil and Paralysis Phil Tetlock and Barbara Mellers were in a race against time to save their 15-year-old daughter, Jenny. As I reported last summer, Jenny developed a degenerative muscle disease nearly two years ago, soon after being vaccinated against the cervical-cancer-causing HPV. She became nearly completely paralyzed, though her mind was perfectly intact and she could still enjoy her pet parakeet, Hannah Montana, and Twilight. I've been E-mailing Phil regularly over the past year, and up until our last E-mail, one week ago, he had been holding out hope that they would be able to find a cure for his daughter—or to at least determine if the human papillomavirus vaccine called Gardasil had caused his daughter's illness, most likely a juvenile form of amyotrophic lateral sclerosis (aka Lou Gehrig's disease). Sadly, the clock ran out last Sunday, and Jenny passed away. Through their efforts to publicize Jenny's case on their blog, Jenny's parents have connected with two other sets of parents whose daughters developed what appears to be ALS after being injected with Gardasil. One was 22-year-old Whitney Baird, who died last August, just 13 months after receiving Gardasil. Another is Alicia Olund, a 12-year-old who began having trouble walking after getting her third shot last September. She now uses leg braces and a walker at home as her muscles continue to deteriorate. After ruling out other conditions, her specialists at the University of California-San Francisco Medical Center—who also treated Jenny—suspect that Alicia may have the same condition. "They don't know what she has," her mother, Barbara, tells me through tears, "but it's destroying her nerves and muscles, and none of the treatments they've given her are working. Before the vaccine, she was a perfectly healthy child, going for her brown belt in karate." (They're awaiting the results of the ALS test.) I should point out that juvenile ALS is extremely rare, affecting just 1 in 2 million young people. It's impossible to say at this point whether these girls would have developed the condition regardless of whether they received Gardasil, but government officials—who still strongly maintain that the vaccine is perfectly safe and potentially lifesaving—are now starting to investigate. Scientists from the Food and Drug Administration met recently with Jenny's neurologists
at UCSF to discuss whether it's scientifically plausible for a vaccine to trigger ALS. And the Centers for Disease Control and Prevention is planning to scour its adverse-event database, called VAERS, to see whether other vaccinations have led to reports of ALS or other severe neurological complications. Turns out, warnings concerning ALS and vaccines have been raised before. John Iskander, the CDC's associate director for immunization safety, tells me the agency previously has received reports of ALS following the anthrax vaccine. This, in addition to the deaths of Jenny and Whitney, "kind of tells us that we need to look more broadly at this issue," he says. He's quick to add that "we're doing just an initial review at this point; we don't have suspicions that these are casually related." Merck, the manufacturer of Gardasil, maintains that its vaccine is extremely safe and points out that it could potentially save women from dying ofcervical cancer
. "There are unusual and rare diseases that occur in girls and women in this age group whether they're vaccinated or not," says Rick Haupt, Merck's head of the clinical program for Gardasil. "These patterns don't indicate any causality." He says no cases of ALS occurred in Merck's clinical trials but also admits that the trials—which included thousands, not millions—weren't large enough to detect such rare diseases. Barbara Shapiro, an ALS expert and associate professor of neurology at Case Western Reserve University School of Medicine who was enlisted by a mutual friend to help the Tetlocks do their research, isn't ready to dismiss the cases as pure coincidence. She's pored over the medical records of Jenny, Whitney, and Alicia and sees a striking similarity. "Juvenile ALS tends to progress very slowly over years or even decades, but these girls all seemed to have a more rapid, progressive form." She also has uncovered another VAERS report in the CDC database that could be similar, but since it was filed by a pharmacist, the CDC told her it doesn't have details on the girl's identity. Shapiro worries that there may be more cases out there that the CDC doesn't know about. After all, she tells me, both Whitney and Alicia came to the CDC's attention only after their parents discovered Jenny's blog and Phil Tetlock urged them to file a VAERS report. This system of voluntary reporting of adverse events related to vaccines by doctors and patients is notoriously crude. All too often, adverse events go unreported, whereas many reports that are filed turn out not to be related at all to the vaccines. When I point this out to Iskander, he tells me that while VAERS certainly isn't perfect, it's pretty good at catching rare events. But what if doctors wouldn't think to link the onset of ALS with a vaccination? I press him. "Reports in the media, such as the one you're doing, are a good trigger to get doctors to file reports," he responds. In fact, largely because of media attention, reports of adverse events for Gardasil are about five times as high as the overall average for any vaccine, he adds. So I suppose he's hoping that if there are other girls out there who developed severe physical disabilities after receiving Gardasil, they'll soon be entered into the VAERS database. Still, I'm troubled by the complexities of all of this. How will the CDC ever be able to know whether there's a true connection between Gardasil and ALS if this disease is so rare? And just how much evidence is needed? Iskander tells me he doesn't make that decision but passes on all the information he has to the government's vaccine working group, which makes recommendations about the national immunization schedule. "They are aware of these cases and that we've started discussions with neurologists and immunologists to determine if there are mechanisms that could explain how a vaccine could cause ALS," Iskander says, adding that "I haven't heard a good answer yet from these experts" when it comes to explaining a mechanism. Shapiro says her suspicions are raised enough that she's decided not to give her own 11-year-old daughter the Gardasil vaccine. "Let's say it causes just one or two cases of ALS every year out of a million doses that are given. What if your daughter is the one?" I haven't decided yet whether I want to have my own teenage daughter vaccinated. The arguments for Gardasil are compelling: It protects against viruses responsible for 70 percent of cervical cancers, which still kill many women in this country. Since the vaccine is so new, until more evidence emerges I think it may be prudent for concerned parents to consider holding off until their daughters reach the verge of sexual activity. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
52%) of HPV-16 DNA in the mouths of prepubertal children, albeit with low levels of transcription [Rice et al., [
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