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Vaccine Safety - Why It's Important to Monitor Vaccine Safety - 0 views

  • Why It’s Important to Monitor Vaccine Safety John Iskander, MD, MPH, acting director, Immunization Safety Office, and Robert T. Chen, MD, MA, blood safety specialist, Epidemiology Branch, NCHHSTP, wrote a chapter in the new book Infectious Disease Surveillance to explain why it is important to monitor vaccine safety. Rare Reactions. The most important reason is to detect rare reactions. Although vaccines are tested extensively before they are licensed for use in the United States, not enough people are included in the tests to detect reactions that happen only rarely. If serious reactions are found when the vaccine is in widespread use, the vaccine may be withdrawn. Higher Risk Groups. Vaccine safety monitoring also makes sure new vaccines are safe for groups such as the elderly, those with chronic medical conditions, and pregnant women. Vaccine trials may deliberately exclude members of these groups. Public Confidence in Vaccines. Monitoring vaccine safety also helps to maintain public confidence needed to keep enough people vaccinated to prevent disease outbreaks. How We Know If Vaccines Are Safe Vaccine safety cannot be measured directly. Instead, it is estimated by the number of "adverse events" reported. An adverse event is "... a medical incident that takes place after an immunization ... and is believed to be caused by the immunization."1 Adverse events include— True reactions to the vaccine. Events that would have occurred even if the person had not been vaccinated (unrelated coincidences). Reactions related to mistakes in vaccine preparation, handling, or administration. Events that cannot be related directly to the vaccine; their cause is unknown. A formal scientific study usually is required to distinguish between coincidences and true reactions. It is rarely possible to say for sure whether a vaccine caused a specific adverse event. Almost all national immunization programs have a system for reporting adverse events. The United States Vaccine Adverse Event Reporting System (VAERS)2 and the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS)* are examples. People who report a vaccine reaction to VAERS or CAEFISS are asked if the reaction led to hospitalization, life-threatening illness, disability, or death. These events are classified as "serious," and are often subject to further study that yields important information. For example, reports to CAEFISS identified a common illness among people who received flu vaccines from one Canadian manufacturer in one season.3 Equally important, such systems have supported the safety of new vaccines such as the new meningococcal B and C vaccines in New Zealand and the United Kingdom. Other monitoring programs include the Vaccine Safety Datalink (VSD) project, the Clinical Immunization Safety Assessment (CISA) Network, and the Brighton Collaboration. The VSD project is a collaboration between CDC's Immunization Safety Office and eight large managed care organizations that allows for planned vaccine safety studies as well as quick investigation of possible issues. The CISA Network of six medical research centers conducts clinical research on vaccine-associated health risks, and the Brighton Collaboration develops standard case definitions for problems following immunization as well as guidelines for data collection, analysis, and presentation. Vaccine safety monitoring becomes more important with new vaccines, expanded vaccine recommendations, and new global immunization initiatives. Reporting systems like VAERS will continue to be used to monitor adverse events, so vaccines can continue to be held to very high standards of safety.
vtravis

US Death Toll Associated with HPV Vaccine Jumps to 11 with 3779 Adverse Reactions Reported - 0 views

  • WASHINGTON, DC, October 5, 2007 (LifeSiteNews.com) - Judicial Watch, the public interest group that investigates and prosecutes government corruption, yesterday released new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing a total of as many as eleven deaths related to Merck's HPV vaccine Gardasil.  Those deaths resulted between June 8, 2006 - when the vaccine received approval from the U.S. Food and Drug Administration (FDA) - and August 2007 when the latest data was available. The adverse reports coming from the HPV vaccine are increasing daily at an alarming rate.  A LifeSiteNews.com report which scanned a publicly available database of adverse affects coming from the HPV vaccine found 3,137 adverse effects reported on September 28, 2007.  Today the US Government's Vaccine Adverse Event Reporting System (VAERS) lists 3,779 adverse effects.  52 of the cases were deemed "life threatening" and 119 required hospitalization. In one case highlighted by Judicial Watch a 17 year old girl who was vaccinated in June 2007 died the very day she was vaccinated.  According to the report, she "was vaccinated with a first dose of Gardasil…During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful.  The patient subsequently died." Other serious reported side effects associated with Gardasil include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.  Says one report: "Initial and follow-up information has been received from a physician concerning an "otherwise healthy" 13 year old female who was vaccinated with her first and second doses of Gardasil.  Subsequently, the patient experienced…paralysis from the chest down, lesions of the optic nerve…At the time of the report, the patient had not recovered." "In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls," said Judicial Watch President Tom Fitton.  "These adverse reaction reports suggest the vaccine not only causes serious side effects, but might even be fatal." The toll from the HPV vaccine may be greater still.  Judicial Watch filed its request on August 20, 2007, and received the adverse event reports from the FDA on September, 13 2007, in what the agency described as a "partial response." On October 3, 2007, Judicial Watch filed a new lawsuit against the FDA for its failure to fully respond to Judicial Watch's FOIA request as required by law.
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GARDASIL AND HPV INFECTION - 0 views

  • GARDASIL AND HPV INFECTION — GET THE FACTS NATIONAL VACCINE INFORMATION CENTER National Vaccine Information Center (Debold V, Downey C, Fisher B). (2007). NVIC Analysis of Vaccine Adverse Events Reporting System Reports: Part III, Human Papilloma Virus Vaccine Safety, Analysis of Vaccine Adverse Events Reporting System Reports: Part III (August 15, 2007 http://www.nvic.org/Diseases/HPV/HPV_Vaccine_Safety_ Report__Part_III_(081507_revised)[1].pdf NVIC Analysis Shows Greater Risk of GBS Reports When HPV Vaccine Is Given with Other Vaccines, August 15, 2007, NVIC Press Release NVIC Letter to ACIP Chairman regarding HPV VAERS reports, August 14, 2007 Making An Informed Decision: WUSA-9, Washington DC, November 28, 2007 Listen to Parents! Not Merck, March 8, 2007, Rally in Washington DC Statement at DC Rally by Barbara Loe Fisher, March 8, 2007 Vaccine Safety Group Releases GARDASIL Reaction Report, February 21, 2007, NVIC Press Release -FDA and CDC Should Warn  Doctors National Vaccine Information Center (Debold V, Fisher B). (2007). Human Papilloma Virus Vaccine Safety, Analysis of Vaccine Adverse Events Reporting System Reports: Part II (February 21, 2007). http://www.nvic.org/Diseases/HPV/HPVRPT2.htm HPV Infection Facts  National Vaccine Information Center (Debold V, Fisher B). (2007). Human Papilloma Virus Vaccine Safety, Analysis of Vaccine Adverse Events Reporting System Reports: Adverse Reactions, Concerns and Implications (undated). http://www.nvic.org/Diseases/HPV/HPVrpt.htm HPV Vaccine Mandates Risky and Expensive, February 1, 2007, NVIC Press Release and Citations Survey of GARDASIL Costs — Private Pediatricians Offices, January 2007 Merck's GARDASIL Not Proven Safe for Little Girls, June 27, 2006, NVIC Press Release on GARDASIL aluminum content and clinical trials with reference citations  TODAY SHOW - FEBRUARY 13, 2007 - Should HPV Vaccine Be Mandatory?  Barbara Loe Fisher, NVIC President and Co-founder, http://tinyurl.com/2kfkb4 HPV Video - 7 Minutes, Grindley Productions made for NVIC WNYC Radio (NPR) The Brian Lehrer Show February 22, 2007 Healthy & Wise: "Strange Bedfellows" "At least 20 states are considering mandatory vaccination of young girls against the sexually transmitted virus that causes cervical cancer. But the backlash has been fast and furious--and has led to some unlikely alliances. Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, and Moira Gaul, director of women's and reproductive health at the Family Research Council, talk about their opposition to mandatory vaccination. Sheila Krumholz, executive director, Center for Responsive Politics, talks about the lobbying efforts and legislative influence of the pharmaceutical industry." VAERS REPORTS — GARDASIL ADVERSE EVENT REPORTS VAERS REPORT — GARDASIL ADVERSE EVENTS REPORTS National Vaccine Information Center. VAERS reports related to HPV4 vaccine http://www.medalerts.
vtravis

HPV/cervical cancer vaccine - 0 views

shared by vtravis on 29 Mar 08 - Cached
  • For starters, it could cause harm. All vaccines carry the risk of injury or death. During trials, nine individuals developed arthritis after receiving the vaccine versus three for the placebo, out of approximately 21,000 individuals in that trial. Nine kids with arthritis after receiving the vaccine might not seem like a big deal in the grand scheme of things. After all, arthritis is better than cancer, right? That depends. Given the fact that cervical cancer is relatively rare, highly preventable and most often successfully treated early on, maybe the risk of arthritis — a painful and often debilitating disease — isn’t a worthwhile trade-off.
  • In order to learn the truth about an unknown, honest science dictates that we have to compare it to a known. When most people think about a vaccine placebo, they are probably thinking about saline. But that’s not what was used during trials. The “placebo” in this case was an aluminium-containing shot. The vaccine itself also contains aluminium. Aluminium hydroxide is what’s known as an adjuvant — it stimulates immune response. Studies in both animals and humans have found that aluminium adjuvants can cause death of brain cells. Similar studies have also shown that aluminium adjuvants in vaccines can cross the blood-brain barrier, as well as cause injection-site inflammation leading to chronic joint and muscle pain and fatigue. Aluminium adjuvants have never been subjected to clinical trials for safety. Read that again: Although the metal has been used in vaccines for decades, it has never been rigorously studied for long-term safety. So perhaps the 1 case of lupus and 2 cases of arthritis out of 9,701 participants who received the “placebo” were not just statistical anomalies. Maybe it was the aluminium. Perhaps that would also explain the 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis and 1 case of reactive arthritis in 11,813 Gardasil recipients. We’ll never know. (Some of the trial participants did, in fact, receive straight saline but there’s no way to tell from the data released which cases are which.) More importantly, a reactive placebo artificially decreases the appearance of danger of an experimental vaccine in a clinical trial because the drug company only has to prove that adverse events weren’t statistically significant in the vaccine group versus the placebo group. So using aluminium-containing placebos falsely inflates the adverse-event data of the “placebo” group, making the vaccine look relatively safe by comparison. Gardasil contains 225 mcg of aluminium. Neither Merck nor the U.S. FDA would answer my questions as to how much aluminium was used in the placebo. (Sanofi Pasteur MSD is marketing the vaccine in Europe and is a joint venture of French company Sanofi Pasteur and U.S. pharmaceutical company Merck.) Clinical trial investigators dismissed most of the 102 serious adverse events including 17 deaths that occurred in the clinical trials as unrelated to the study. But given the reactivity profile of aluminium, can we really say that for sure?
  • Those who received the vaccine reported even more serious adverse events such as gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis. In a never before done study, scientists recently found a link between aluminium in vaccines and symptoms associated with Parkinson’s, amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) and Alzheimer’s. “This is suspicious,” neuroscientist Chris Shaw told the Georgia Straight, Canada’s largest urban weekly. “Either this [link] is known by industry and it was never made public, or industry was never made to do these studies by Health Canada. I’m not sure which is scarier.” Shaw said there could be 10,000 studies showing aluminium hydroxide is safe to be injected, but that he hasn’t been able to find one study that looked beyond the first few weeks of injection. The reason this is significant, according to Shaw, is that neurological damage can take years to manifest.
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  • Fisher went on to explain that Merck did not reveal in public documents exactly how many 9- to 15-year-old girls were in the clinical trials and how many of them had serious adverse events after being injected with Gardasil or the aluminium-containing placebo. “For example, if there were fewer than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.
  • Sanofi Pasteur and Merck have an enormous amount at stake in the universal administration of the shots. A place on the childhood vaccination schedule means a steady and exponentially larger revenue stream. Financial analysts predict Gardasil could be Merck’s most important pipeline contributor to top-line growth, with peak sales of at least $2 billion — revenue Merck badly needs after the Vioxx scandals. That revenue figure assumes that Gardasil will be required for school admittance. “It’s a stockholders dream,” said Barbara Loe Fisher, president of the NVIC, a U.S. non-profit organisation that promotes the right to informed consent on vaccine decisions. Fisher sat on the FDA’s committee that reviews vaccines in 2001, when the vaccine underwent early reviews.
  • HPV does not lurk in the air, in swimming pools or on playground equipment. That makes the vaccine’s public health credentials dubious at best.
vtravis

New Page 4 - 0 views

  • Vienna, Virginia - The National Vaccine Information Center (NVIC), the nation's leading vaccine safety and informed consent advocacy organization, is urging state legislatures to investigate the safety and cost of mandating Merck's HPV vaccine (GARDASIL) for all pre-adolescent girls before introducing legislation amending state vaccine laws. In an analysis of reports made to the federal Vaccine Adverse Event Reporting System (VAERS) since the CDC's July 2006 universal use recommendation for all young girls, NVIC found reports of loss of consciousness, seizures, joint pain and Guillain-Barre Syndrome. In a separate evaluation of costs for young girls being vaccinated in private pediatrician offices, NVIC discovered that parents living in the Washington, D.C. area will be paying between $500 and $900 to have their daughters receive three doses of GARDASIL. "GARDASIL safety appears to have been studied in fewer than 2,000 girls aged 9 to 15 years and it is unclear how long they were followed up. [1] VAERS is now receiving reports of loss of consciousness, seizures, arthritis and other neurological problems in young girls who have received the shot," said NVIC President Barbara Loe Fisher. "At the same time, parents who take their daughters to private pediatricians are going to be shocked to find that they will be paying two to three times the widely publicized $360 cost for the three-dose series. The cost is going to break the pocketbooks of parents and break the banks of both insurance companies and taxpayers, when the reality is that almost all cases of HPV-associated cervical cancer can be prevented with annual pap screening of girls who are sexually active." Between July 2006 and January 2007, there have been 82 reports of adverse events filed with VAERS following receipt of GARDASIL by girls and boys ranging in age from 11 to 27 years. Reaction reports have come from 21 states, including Virginia and the District of Columbia. All but three of the reports were for adverse events which occurred within one week of vaccination and more than 60 percent occurred within 24 hours of vaccination. "The most frequent serious health events after GARDASIL shots are neurological symptoms," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "These young girls are experiencing severe headaches, dizziness, temporary loss of vision, slurred speech, fainting, involuntary contraction of limbs (seizures), muscle weakness, tingling and numbness in the hands and feet and joint pain. Some of the girls have lost consciousness during what appears to be seizures." Debold added "The manufacturer product insert should include mention of syncopal episodes, seizures and Guillain-Barre Syndrome so doctors and parents are aware these vaccine adverse responses have been associated with the vaccine."
  • HPV is the most common sexually transmitted infection in the U.S. and most persons naturally clear the infection from the body without symptoms. [3] However, many years of chronic HPV infection is associated with a higher risk of pre-cancerous changes in the cervix that can lead to cancer unless diagnosed and treated promptly. High risk factors for chronic HPV infection include smoking, long-term use of oral contraceptives and co-infection with HIV, herpes and chlamydia. [4] There has been a more than 70 percent drop in cervical cancer deaths in American women since the 1950's due to routine pap smears and nearly all cervical cancers can be prevented with regular pap smear screening and treatment. [5]
vtravis

Shots In The Dark - Articles - 0 views

  • Shots In The Dark by Barbara Loe Fisher   The worldwide acceptance of mass vaccination to suppress infectious childhood diseases once fiercely resisted is one of the most successful public relations stories in the history of medicine. As a result, epidemics of smallpox, which once swept through 18th- and 19th-century port cities such as Halifax, New York, and Boston without warning and cut down entire families, are now dry facts relegated to medical books. Images of children struggling through whooping cough, walking down the street coughing spasmodically, and stopping at curbs to spit up sticky mucus are only fading memories for grandparents alive to talk about what their parents told them.  Baby boomers and their parents still remember lining up in school in 1955 for polio vaccinations, with the hope that this magic bullet would keep them out of the dreaded iron lung.  Mass vaccination has dramatically suppressed childhood diseases. In Canada, recorded diphtheria cases dropped from 9,000 in 1924 to two to five by 1994.  When measles vaccination began in the United States between 1963 and 1965, doctors reported more than 400,000 cases annually; by 1995, that number had dwindled to 309. Cases of tetanus are almost unheard of in North America and Europe.   Yet the universal use of vaccines as a worthy goal that prevents needless suffering and that benefits all mankind has begun to be challenged.   The voices of critics are heard in the living rooms of families whose children have been injured or have died from reactions to routine childhood vaccinations, and in courtrooms, where parents are suing vaccine makers and challenging mandatory vaccination laws. In the U.S. Congress, legislators who have heard them have set up a vaccine injury compensation program. At scientific conferences and in the pages of prestigious medical journals, researchers and physicians are risking their careers by discussing vaccine side effects.
  • Today, vaccinations are big business. In 1995, an international high-technology research firm, Frost & Sullivan, projected that the worldwide human vaccine market will increase from $2.9 billion to more than $7 billion by the year 2001.   Public health officials in every country assist the industry�s growth, often by force of laws that ensure citizens use about a dozen different viral and bacterial vaccines, including ones to suppress even generally mild childhood diseases such as chicken pox. Traditional public health measures, improving sanitation, nutrition, living conditions, health education, and access to affordable medical care, especially in underprivileged populations often take a backseat to achieving a 100 per cent vaccination rate.   Most medical doctors consider vaccines their single most important tool in protecting public health. Few would question the profound importance of vaccines to public health, wrote Richard B. Johnston, Jr., MD, medical director of the March of Dimes and chairman of the Institute of Medicine Vaccine Safety Committee, in a 1994 National Academy of Sciences report, 
  • Adverse Events Associated with Vaccines Not only have deaths from the most common childhood infections been almost eliminated, but also so have the devastating morbidities of diseases like measles, paralytic polio, and congenital rubella. This revolution has . . . led to major savings in medical costs and gains in work productivity, as well as to reductions in deaths and suffering.   An ancient philosophical dispute goes modern   The whole idea of man versus nature can be traced back to the origins of western medicine more than 2,000 years ago. In a four-volume book series Divided Legacy: A History of Schism in Medical Thought by medical historian Harris L. Coulter, PhD, the centuries-old war between empiricism and rationalism in medicine is revealed as a contest between two competing health philosophies. Is each individual governed by a vital force that, through unique reactions to external stimuli, is capable of participating in the healing process, as empiricists, including Hippocrates, have maintained?  Or are all human organisms simply a series of complex chemical reactions governed by the laws of physics, chemistry, and mechanics, as rationalists, including Louis Pasteur, have maintained?   Empiricists accept the existence of viruses and bacteria as part of nature and illness as part of the life process. They consider fevers, diarrhea, and runny noses good, not bad, and do not suppress them with chemically based drugs that might interfere with the body�s natural ability to harness the immune system to participate in the healing process. They stress that each individual is unique and that individualized therapeutic techniques can stimulate the body to restore health. Empiricists dislike the one-size-fits-all mass vaccination approach. 
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  • A 1997 study in the Canadian Journal of Public Health estimated that 15 per cent of Canadians had seen an alternative therapy practitioner in the preceding 12 months. A 1998 survey in JAMA found 39 million Americans made more than 600 million visits to alternative health care practitioners in 1997, more than to primary care physicians. The patients paid most of the  $21.2 billion cost themselves because health insurance plans generally don�t reimburse patients for alternative health care. The patients wanted alternative therapies primarily to prevent future illness from occurring or to maintain health and vitality.   Embracing the more spiritual concept of achieving better health through better living rather than through better chemistry, members of the Me generation -- who challenged every institution and social more as teenagers  -- continue to exercise their counterculture instincts as adults by asserting their right to make independent health care choices. Their demand to make vaccination choices puzzles and worries MDs, including some outspoken alternative health care advocates.   Vaccines are supposed to fool the body's immune system into producing antibodies to resist viral and bacterial infection in the same way that actually having the disease usually produces immunity to future infection.  But unlike natural recovery from many infectious diseases, which stimulates lifetime immunity, vaccines only provide temporary protection. That�s why booster doses are often required.   Vaccination raises two equally contentious questions. First, is it better to protect children against infectious diseases early in life through temporary immunity from a vaccine or are they better off contracting certain contagious infections in childhood and attaining permanent immunity? Second, do vaccine complications cause more injury and death than diseases do? Both questions essentially pit trust in human intervention against trust in nature.    The rise of asthma and other autoimmune diseases  
  • Autism soars   Other scientists researching health problems associated with vaccines have also felt the ire of public health officials. In 1998, an unsuspecting young British gastroenterologist suddenly found himself in the eye of a hurricane for discovering a possible connection between the MMR vaccine and autism.   In the February 27, 1998, issue of The Lancet, Andrew Wakefield, MD, and 13 colleagues reported on a new syndrome involving inflammatory bowel disease and autism in children. Eight out of 12 normal children who developed severe intestinal disorders soon after an MMR vaccination also became autistic.  Previously, five of those eight children had reacted adversely to vaccinations.  
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  • The blunt truth is that some children are harmed by vaccinations. Research, not denial, is the proper response to this report.   Portia Iverson, founder and president of CAN, the Cure Autism Now foundation in Los Angeles, also took issue at the government-led criticism:  Approximately one-half of the hundreds of parents who call our office each month report that their child became autistic shortly after receiving a vaccination. Isn�t it the responsibility of the government to take a pro-active position on behalf of these children rather than a defensive one?   Like incidences of asthma and diabetes, the incidence of autism has climbed dramatically in the past 30 years. Although the medical literature identified only a handful of cases in the 1940s, by the mid-1960s, after the DPT vaccine had been widely used and the measles vaccine introduced, autistic children began flooding doctors� offices. (Parents in the U.S. and Canada who report vaccine-associated autism most often mention that their children�s autistic behaviors followed DPT or MMR vaccination.) Today, 1 in 1,000 children are diagnosed as autistic, making autism more prevalent among children than cancer, multiple sclerosis, or cystic fibrosis. A recent California study put the figure at 1 in 312 children, a 273 per cent increase between 1987 and 1998.  
  • Hepatitis B vaccine takes a hit   Canadian physicians have also faced criticism from government health officials who dismiss vaccine side effects. Byron Hyde, MD, chairman of the Ottawa-based Nightingale Research Foundation and an internationally recognized authority on myalgic encephalomyelitis (chronic fatigue syndrome), has accumulated data on several hundred cases of serious immune and neurological dysfunction following hepatitis B vaccination. His first case reports, in the early 1990s, came from Quebec nurses who reported a constellation of autoimmune symptoms, including pain, fatigue, and mental dysfunction, and were unable to work.   Hyde, a vaccination advocate, spoke out publicly about the side effects in September 1997 at the First International Public Conference on Vaccination sponsored by the National Vaccine Information Center in Washington, D.C. He told more than 500 parents and doctors that in the early 1990s, both the vaccine manufacturer and the Canadian health authorities repeatedly rebuffed his requests for an investigation into signs of demyelinating disease, measurable loss of IQ, loss of stamina, intractable pain, blindness, skin lesions, and other problems affecting health care workers following their hepatitis B vaccinations. 
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HPV Vaccine Study : Merck study (Lancet Oncol, Avril 2005) - Actions Traitements - 0 views

  • Methods 277 young women (mean age 20·2 years [SD 1·7]) were randomly assigned to quadrivalent HPV (20 É g type 6, 40 É g type 11, 40 É g type 16, and 20 É g type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20·0 years [1·7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV, and Pap testing. The primary endpoint was the combined incidence of infection with HPV 6, 11, 16, or 18, or cervical or external genital disease (ie, persistent HPV infection, HPV detection at the last recorded visit, cervical intraepithelial neoplasia, cervical cancer, or external genital lesions caused by the HPV types in the vaccine). Main analyses were done per protocol. Findings Combined incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% (95% CI 71-97, p<0·0001) in those assigned vaccine compared with those assigned placebo. Interpretation A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types. AUTHOR DISCUSSION We have shown that a multivalent vaccine is efficacious against HPV types that cause cancer and genital warts. Over 35 months’ follow-up, incidence of persistent infection associated with HPV 6, 11, 16, or 18 decreased by 89% in women allocated active vaccine who had at least one dose (ie, the modified intention-to-treat population) compared with those allocated placebo. Vaccine efficacy was 90% in the per-protocol efficacy population, suggesting that the vaccine was protective even during the vaccination period. For example, during the course of vaccination (day 1 through month 7), three women assigned active vaccine and five women assigned placebo were detected with HPV 18 DNA. Of these, only one was verifiable persistent infection (in the placebo group). Thus, one woman allocated placebo and no women allocated active vaccine developed persistent HPV 18 infection during the vaccination period. Furthermore, efficacy with regard to clinical disease associated with HPV 6, 11, 16, or 18 was 100%.
  • Methods Study design A phase II randomised, multicentre, double-blind placebo-controlled study of a quadrivalent HPV (type 6, 11, 16, and 18) L1 VLP vaccine was done in two parts. Part A was a sequential dose-escalation safety assessment, in which participants, investigators, and staff were blinded as to assignment of vaccine or placebo, but not to assignment of doses in the active-treatment group. Part B was a fully blinded dose-ranging assessment of immunogenicity and efficacy. Study procedures for individuals in part A and part B were identical. The results presented in this article are from part B. 1158 women aged 16-23 years were recruited in Brazil, Europe, and the USA. The study enrolled healthy women, who were not pregnant, had no previous abnormal Pap smears, and reported a lifetime history of four or fewer male sex partners. Enrolment of virgins was restricted to women who were 18 years or older and who were seeking contraception. This study did not exclude women with previous HPV infection. Participants were required to use effective contraception during the trial. The active quadrivalent vaccine was a mixture of four recombinant HPV type-specific VLPs (Merck Research Laboratories, West Point, PA, USA) consisting of the L1 major capsid proteins of HPV 6, 11, 16, and 18 synthesised in Saccharomyces cerevisiae.10,14,16 The four VLP types were purified and adsorbed onto amorphous aluminium hydroxyphosphate sulfate adjuvant. The placebo consisted of the same adjuvant and was visually indistinguishable from vaccine. Three preparations of a quadrivalent HPV types 6, 11, 16, and 18 L1 VLP were used. The three preparations were : 20 É g type 6, 40 É g type 11, 40 É g type 16, and 20 É g type 18, with 225 É g aluminium adjuvant ; 40 É g type 6, 40 É g type 11, 40 É g type 16, and 40 É g type 18, with 225 É g aluminium adjuvant ; and 80 É g type 6, 80 É g type 11, 40 É g type 16, and 80 É g type 18, with 395 É g aluminium adjuvant. The study had two placebo groups with adjuvant doses of 225 É g or 450 É g for appropriate safety comparisons. 0·5 mL vaccine or placebo was given by intramuscular injection at day 1, month 2, and month 6. After vaccination, participants were observed for 30 min. Temperatures were also recorded orally every day in the evening for 5 days after vaccination, and the participant noted adverse events by standard diary card for 14 days after vaccination. Gynaecological examination was done at day 1 and at months 7, 12, 24, and 36. A ThinPrep™ Pap test (Cytyc, Boxborough, MA, USA) and external genital, lateral vaginal, and cervical swabs for PCR analysis of HPV were obtained from all participants at day 1 and at months 7, 12, 18, 24, 30, and 36. Biopsy samples of external genital lesions identified during the study were taken, and serum samples were obtained at day 1 and months 2, 3, 6, 7, 12, 18, 24, 30, and 36. This study was done in accordance with national or local requirements for ethics-committee review, informed consent, and other statutes or regulations regarding the protection of the rights and welfare of those participating in biomedical research. All individuals, or their parents or legal guardians, gave written informed consent after review of the protocol procedures. The aim of the study was to assess a quadrivalent HPV L1 VLP vaccine in terms of the composite primary endpoint of persistent infection associated with HPV 6, 11, 16, or 18, or cervical or external genital disease compared with placebo. Women with persistent infection were defined as those who had the same vaccine-HPV-type DNA in cervicovaginal samples obtained 7 months after vaccination as those obtained from two or more consecutive visits (required to be 4 months or longer apart unless at least one tissue sample was diagnosed as cervical disease by a panel of pathologists), or as those who had vaccine-HPV-type DNA detected in a sample recorded during the last visit before being lost to follow-up. HPV-associated disease was defined as a tissue sample diagnosed as CIN by a panel of pathologists 7 months after vaccination ; vulval intraepithelial neoplasia ; vaginal intraepithelial neoplasia ; external genital warts ; or cervical, vulval, or vaginal cancer with vaccine-HPV-type DNA detected in tissue from, or in a swab of, the same lesion and in cervicovaginal samples obtained at the visit before the biopsy visit.
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Dr Hyde on hepatitis B vaccine and CFS/Chronic fatigue syndrome - 0 views

shared by vtravis on 11 Mar 08 - Cached
  • He defines CFS as an epidemic illness, one which occurs primarily in the late summer and fall. It is typified by an acute onset of symptoms which vary from malaise to severe non-stop headaches and body pains now known in the US as fibromyalgia or myalgias. It is also accompanied by muscle weakness which develop alongside the pain symptoms and changes in brain function. The change in brain function is in several areas with one, a measurable decrease in the expected IQ, and, two, major cognitive losses that is, loss of sensory abilities to define one’s environment. which is very traumatic for the patients. Physicians have found very few physical modalities of the disease to help them to further diagnose the disease. The disease process, he adds, very much resembles poliomyelitis in its incubation period. Prior to 1962, before polio immunization became generalized. epidemics of CFS like disease occurred concurrently with polio epidemics. A lot of people at that time felt that there may be a type of poliomyelitis-type injury without the paralytic dysfunction. "My supposed expertise with hep B immunisation. And I say "supposed" because we know almost nothing….We know very little about hep B disease. We have no statistics in Canada, serious statistics. We don’t know, for instance, how many children in Canada die of it every year. There are no statistics. We don’t know who the people who fall ill with hep B are. Are they Haitian immigrants? Are they people who have just arrived from China? There are no government statistics on this information…. Why are we, in a time of major economic, medical and financial difficulty, spending literally a billion dollars, because that is what it would cost to immunise everybody in Canada against hepatitis B, for something in which we have the lowest risk in the world, for which we have no statistics, and for which there is no serious investigation on the side effects? I would not for a minute say not to take hep B immunisation if you work in a hospital dealing with blood products….We have to know what we are doing in medicine before we go and immunise tens of thousands, hundreds of thousands of children…Because if they develop brain dysfunction after hep B immunisation when they’re in kindergarten, who in the world will know the reason if they fail grades one, two, three and four? Was it because they were stupid, not motivated, not intellectually able, or on drugs? Who is going to know if it is that or if they were brain dysfunctions due to immunisations that, we know, occur to minor degrees in many types of immunisations? I did have a chance to spend a couple of evenings with the man in charge of getting the American soldiers ready for the Gulf (in Baton Rouge). He was in charge of anti-chemical, anti-germ warfare. He told me that many of the Gulf War Syndrom people were hospitalised immediately after massive immunisations and never got to the Gulf. I have never seen that written up. It is very interesting to note that hep B immunisation was only given to those people sent to the Gulf who were mediacl personnel, because they did not feel there was a risk for the regular soldier. Now, if the American government did not feel it was a risk to people in combat, it makes us wonder why we are giving it to our children today. We looked at hep B immunisation in Quebec province because one nurse phoned us saying she had CFS after having hep B immunization.....About a month later the same nurse called again, she now had 5 other nurses in the area who had fallen ill with CFS-like symptoms after the vaccine, all were unable to return to work. I told her to phone the maker, Merck. She told me she did and they said the 6 nurses were the only persons in the whole world that had ever had a serious side effect and therefore there couldn't possibly be a link. And, they told her that she was the only person who had ever phoned....she said that when her doctor phoned, he too was told he was the only person in the world that had ever called, and when each of the doctors of the other nurses called in, each was told the same thing. I also called Merck...and they said.."Oh Dr Hyde, you are the only doctor in all of Canada that has ever contacted us with such a complaint."
  • This same nurse....(had) amassed 20 or 30 names of individuals, all post hep B immunisation cases...We received close to 120 calls from nurses and health care workers in the Quebec area with problems...many were severely disabled." Dr Hyde. Dr Hyde mentioned that the investigation into the hep B vaccine raised after his efforts was funded, organised and run by a pharmaceutical company. He was not invited. "Nor was Dr. Phaneuf who has over 100 cases of post-hepatitis B immunisation in Quebec…Nobody who had ever published a paper on post-hepatitis immunisation adverse reaction was invited (to the Toronto conference on hepatitis B). So it was a very one sided meeting." All paid for by Merck. When he asked the government for a copy of the research they said they had completed using the list of hepatitis B "victims" he had provided, he was told that it had been destroyed for lack of space! Reproduced with permission of Here’s The Key Inc, CP309, Waterloo, Qc JOE 2NO, Canada. Tel: 001 450 297 2533. Fax: 001 450 297 4140 Selected extracts taken from The Trial of the Medical Mafia by Jochim Schafer ISBN 2921783029. Available from: Whale Books, UK. Tel: 01981 240 125. To reach Guylaine Lanctot, M.D. Tel: 001 514 297 4128. Fax: 001 514 297 4140 [Vaccination]  [CFS/ME & vaccines]  [Dr Lanctot]
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