"A 2-year-old boy is being treated in Chicago for a rare and life-threatening infection that he contracted from his father, a U.S. Army soldier recently vaccinated against smallpox. The Indiana boy is in critical condition with eczema vaccinatum, an unusual side effect of the smallpox vaccine that can affect people who receive the shot or their close contacts. Doctors also said the boy appears to have passed the infection to his mother, who has a much milder case of the virus in the smallpox vaccine, which is also called vaccinia.........The boy's rash had spread to cover 80 percent of his body, said Dr.Madelyn Kahana, chief of pediatric intensive care medicine at the U. of C. He was going into sepsis, a devastating, systemwide infection rarely seen with viral cases. "In the later stages of [eczema vaccinatum], it can look like smallpox," said Damon of the CDC. The boy needed a ventilator to help his breathing because of the powerful pain medication he needed for the lesions. The boy received the primary treatment for eczema vaccinatum, a drug called vaccinia immune globulin, or VIG. The drug came from a stockpile the CDC keeps in case widespread vaccination ever becomes necessary. He also got an antiviral drug called cidofovir and the experimental drug ST-246, which has been shown to protect laboratory animals from exposure to smallpox. The drug recently entered preliminary human trials but had never been used in a sick patient. U. of C. officials said the boy has shown signs of improvement since hitting a low point last weekend. Kahana said the boy probably will lose 20 percent of his outer skin layer, but she hopes he will recover without the need for skin grafts." - Jeremy Manier, Chicago Tribune, Smallpox shot infects soldier's toddler son
Boy critically ill; mom also stricken. March 17, 2007
"Gloria Kelly, spokeswoman for the Canadian Forces health services group, said Monday that the Department of National Defence is not considering the same. "At this point in time, we are not requiring our people to have anthrax vaccinations nor are we considering it," Kelly said from Ottawa. Both the Canadian and U.S. militaries ceased mandatory anthrax immunizations after questions arose about the safety and efficacy of the vaccine. The U.S. army continued to offer a voluntary vaccination but only about half of U.S. soldiers signed on. The U.S. Food and Drug Administration has since declared the anthrax vaccine safe and effective, opening the door to the mandatory program south of the border." - Dene Moore, Canadian Press , March 5, 2007, No anthrax vaccine for Afghanistan troops, despite U.S. decision
Barbara Loe Fisher Commentary:
Within weeks of Sept. 11, 2001, there was an announcement by CDC officials that old stockpiles of smallpox vaccine would be diluted to make enough doses to vaccinate millions of Americans in case terrorists used weaponized smallpox to attack the U.S. population. Public health and Department of Defense officials did not explain (1) how the terrorists could have stolen the smallpox virus from one of the two maximum security laboratories in the U.S.or Russia; (2) why terrorists would have the technical expertise and special lab facilities to culture and maintain the viability of the virus; (3) how they could transport the virus in liquid or powder form without destroying its effectiveness; or (4) how they acquired the sophisticated and expensive technology to deliver weaponized smallpox to large numbers of people.
What public health and DOD officials did know post 9-11 is that (1) the old live vaccinia virus vaccine for smallpox was never tested for safety in controlled clinical trials before it was used on a mass basis (2) 1 in 4,000 vacinees suffer severe reactions; (3) those recently vaccinated become infected with vaccinia virus and can transmit the vaccine virus to close contacts, leading to injury and death for some;(4) the most deadly side effects of smallpox vaccination are progressive vaccinia (disintegration of the flesh, internal organs and bones causing death within 6 months); encephalitis/encephalomyelitis (brain inflammation within 25 days after vaccination causing permanent brain damage); eczema vaccinatum (high fever, swollen lymph nodes, inflammation and skin lesions, especially in persons with a history of eczema) or generalized vaccinia (smallpox-like total body rash).
The DOD continues to push the highly reactive smallpox vaccine, as well as the highly reactive anthrax vaccine, on U.S. soldiers without their informed consent while failing to provided any evidence to the American public that weaponized smallpox or anthrax is possessed by any terrorist group with the expertise and means to successfully unleash those weaponized organisms on anyone. Tens of thousands of soldiers have suffered smallpox and anthrax vaccine reactions and tens of hundreds have suffered permanent brain and immune system dysfunction or have died.
The tragic consequences of one-size-fits-all forced vaccination policies in both military and civilian life is that nobody is held accountable when casualties occur. The human casualties are written off as expendable in the name of the greater good, even when the greater good is nowhere to be found.
VA Gov Amends HPV Law: Parents To Decide
"Last month, the [Virginia] House and Senate passed bills to require all girls entering the sixth grade to get the vaccine for the human papillomavirus, or HPV. Del. Phillip Hamilton's bill requires parents wishing to exempt their children from the vaccine to fill out a form from the State Board of Health Regulations for the Immunization of School Children. Kaine's amendment would eliminate the need for parents or guardians to submit written requests for their children to opt out of the vaccine, called Gardasil. "While I believe that this vaccine shows great promise for preventing cancer, I believe that the decision to administer this vaccine should be made by parents," Kaine said in a statement. "My amendments further clarify the provision that a girl's parent or guardian has complete discretion to decide whether their child should be vaccinated." - Kristen Gelineau, AP, Daily Press, March 26, 2007, Kaine proposes HPV vaccine amendment; restaurant smoking ban
Barbara Loe Fisher Commentary:
Congratulations to Virginia Governor Tim Kaine for having the wisdom and vision to amend the nation's first HPV vaccine mandate to an "opt-in" and not an "opt-out" requirement for girls entering the sixth grade. Virginia parents will now have, in the Governor's words, "complete discretion" in choosing whether or not their 11 year old daughters will get three doses of HPV vaccine. Parents will not have to sign a written statement declining the vaccine for records kept by state government health officials.
Governor Kaine and Virginia legislators have come under intense pressure by Merck lobbyists seeking to persuade Virginia and many other states to mandate that girls entering sixth grade get three doses of GARDASIL, a vaccine fast tracked at the FDA and quickly recommended in 2006 by the CDC for girls entering puberty. However, there has been a nationwide parent backlash to the aggressive advertising and lobbying campaign by Merck to require use of GARDASIL for young school girls.
Parent-led organizations, such as NVIC, have opposed vaccine mandates citing lack of vaccine safety and efficacy data for girls under age 16 and questioning the rationale for mandated use of a vaccine for an infection that cannot be transmitted in the public setting for a cancer that has dropped 74 percent in the past four decades because routine pap screening has become standard health care for women in America. Other parent-led organizations oppose the government requiring pre-adolescent girls to use a vaccine for a sexually transmitted disease before they are sexually active because it potentially interferes with parental influence in the teaching of moral values.
Governor Kaine did the right thing: after weighing the benefits and risks of signing the HPV vaccine mandate, he amended it to reflect the will of the people. He gave back to parents and pediatricians the decision of whether or not an 11 year old girl living in Virginia should get three doses of HPV vaccine. And he wisely rejected the idea that the names of those who decline HPV vaccine for their daughters should be put on an "opt-out" list kept by state health officials.
Governors in every state would do well to take note of the vision that Governor Kaine has demonstrated and follow his lead. Education, not coercion, is the best way to encourage citizens to take responsibility for the health care choices they make for themselves and their children. Cost and access barriers to vaccine use can be lowered through legislation without using legislation to force vaccine use upon citizens against their will.
Barbara Loe Fisher Commentary:
Congratulations to Virginia Governor Tim Kaine for having the wisdom and vision to amend the nation's first HPV vaccine mandate to an "opt-in" and not an "opt-out" requirement for girls entering the sixth grade. Virginia parents will now have, in the Governor's words, "complete discretion" in choosing whether or not their 11 year old daughters will get three doses of HPV vaccine. Parents will not have to sign a written statement declining the vaccine for records kept by state government health officials.
Governor Kaine and Virginia legislators have come under intense pressure by Merck lobbyists seeking to persuade Virginia and many other states to mandate that girls entering sixth grade get three doses of GARDASIL, a vaccine fast tracked at the FDA and quickly recommended in 2006 by the CDC for girls entering puberty. However, there has been a nationwide parent backlash to the aggressive advertising and lobbying campaign by Merck to require use of GARDASIL for young school girls.
Parent-led organizations, such as NVIC, have opposed vaccine mandates citing lack of vaccine safety and efficacy data for girls under age 16 and questioning the rationale for mandated use of a vaccine for an infection that cannot be transmitted in the public setting for a cancer that has dropped 74 percent in the past four decades because routine pap screening has become standard health care for women in America. Other parent-led organizations oppose the government requiring pre-adolescent girls to use a vaccine for a sexually transmitted disease before they are sexually active because it potentially interferes with parental influence in the teaching of moral values.
Governor Kaine did the right thing: after weighing the benefits and risks of signing the HPV vaccine mandate, he amended it to reflect the will of the people. He gave back to parents and pediatricians the decision of whether or not an 11 year old girl living in Virginia should get three doses of HPV vaccine. And he wisely rejected the idea that the names of those who decline HPV vaccine for their daughters should be put on an "opt-out" list kept by state health officials.
Governors in every state would do well to take note of the vision that Governor Kaine has demonstrated and follow his lead. Education, not coercion, is the best way to encourage citizens to take responsibility for the health care choices they make for themselves and their children. Cost and access barriers to vaccine use can be lowered through legislation without using legislation to force vaccine use upon citizens against their will.
Chickenpox Vaccine Protection Fails; Booster Needed
"In the New England Journal of Medicine, the researchers confirm what doctors have already known — that the vaccine has sharply reduced the number of cases in children but that its protection does not last long. With fewer natural cases of the disease, the study says, unvaccinated children or those whose first dose of the vaccine fails to work are getting chickenpox later in life, when the risk of complications is higher. “If you’re unvaccinated and you get it later in life, there’s a 20-times greater risk of dying compared to a child, and a 10- to 15-times greater chance of getting hospitalized,” said Dr. Jane Seward of the Centers for Disease Control and Prevention in Atlanta, who worked on the study....The United States has been vaccinating against chickenpox since 1995. But tests have shown that the vaccine is not very effective in 15 percent to 20 percent of children who receive only one dose. A second dose would provide extra protection, but it is not clear how much.." - Reuters, New York Times , March 15, 2007, Chickenpox Vaccine Loses Effectiveness in Study
"Children between the ages of 8 and 12 years who had been vaccinated at least 5 years previously were significantly more likely to have moderate or severe disease than were those who had been vaccinated less than 5 years previously. The annual rate of breakthrough varicella significantly increased with the time since vaccination, from 1.6 cases per 1000 person-years within 1 year after vaccination to 9.0 per 1000 person-years at 5 years and 58.2 per 1000 person-years at 9 years." - Sandra Chavez, M.D. et al., New England Journal of Medicine
Loss of Vaccine-Induced Immunity to Varicella over Time, March 15, 2007
Barbara Loe Fisher Commentary:
In March 1995, when Merck's chickenpox vaccine, VARIVAX, was licensed, the National Vaccine Information Center issued a public statement and I appeared on NBC's "Today Show" questioning why the CDC and AAP were calling for mass use of the live varicella zoster vaccine by all healthy children. Originally developed for leukemic children for whom chicken pox could be deadly, it had taken Merck decades to get VARIVAX licensed for healthy children because it had such a high failure rate: efficacy was known to be 80 percent or less.
In 1995, NVIC went on record as opposing chicken pox vaccine mandates for the following reasons: (1) the childhood disease is highly communicable but mild for the vast majority of young children; (2) disease-induced immunity is qualitatively superior and lasts longer than vaccine induced, temporary immunity so mass vaccination sets up the need for booster shots; (3) mass vaccination will change the epidemiology of the disease and drive it into atypical older age groups where it is far more likely to cause permanent injury or death; (4) shingles cases may increase as chicken pox cases decrease.
On March 14, 2007, CDC officials published an article in the New England Journal of Medicine and confirmed the warning that NVIC issued exactly twelve years earlier: Merck's VARIVAX vaccine has a high failure rate and mass vaccination of American children has driven the disease into atypical older age groups where it can be far more dangerous. Already the CDC has said children between 4 and 6 years need a booster dose and a third booster may well be planned for teenagers..
And what about the chicken pox vaccine's safety? In September 2000, the FDA reported that in the first three years of the vaccine's use, 1 in 33,000 doses was followed by shock, convulsions, encephalitis, thrombocytopenia or death. About 82 percent of the adverse event reports to VAERS occurred in individuals who only received the chicken pox vaccine and led to the addition of 17 adverse events to the Merck product label, including secondary bacterial infections (cellulitis); secondary transmission (infection of close contacts); transverse myelitis; Guillain Barre syndrome and herpes zoster (shingles). On Sept. 13, 2000, NVIC issued a press release and stated "This vaccine should not be mandated. There are too many questions about the true adverse event and efficacy profile of this relatively new live virus vaccine and it is up to the manufacturer marketing the vaccine and the federal agencies regulating the vaccine to conduct further follow-up."
Since 2000, NVIC and VAERS have received continuing reports of brain inflammation, convulsions, vaccine strain chicken pox, shingles, regression into autism and other serious health problems following receipt of VARIVAX alone or in combination with MMR, DTaP, influenza, pneumococcal and other vaccines.
In the past few years, Gary S. Goldman, Ph.D., founder and editor of Medical Veritas, published research in Vaccine and the International Journal of Toxicology documenting an increase in shingles (herpes zoster) in the U.S. after the states mandated use of chickenpox vaccine following the CDC's 1995 "universal use" recommendation. Goldman's research revealed that shingles, a painful nerve inflammation and rash that develops into pus-filled blisters that break open and form scabs and can cause three times as many deaths and five times the number of hospitalizations as chicken pox, is suppressed naturally in a population when older children and adults have their chickenpox-induced immunity asymptomatically "boosted" by coming into contact with younger children infected with chicken pox. Dr. Goldman's findings, summarized in his article "The Case Against Universal Varicella Vaccination" (International Journal of Toxicology, 25:313-317, 2006) corroborate those of other independent researchers questioning the cost-benefit rationale for mandatory vaccination of all children with chickenpox vaccine.
Goldman and others have pointed out that, even if chickenpox was nearly eradicated by mass vaccination, the higher number of shingles cases could continue in the US for up to 50 years with any chickenpox deaths prevented by vaccination offset by deaths from increasing shingles disease. Goldman published a cost-benefit analysis of the mass varicella zoster vaccination program in Vaccine which demonstrated that the 50-year shingles epidemic will cost an excess $4.1 billion in health care costs to the U.S. According to Goldman, "The principal reason that chicken pox vaccines in Japan maintained high levels of immunity 20 years following vaccination was that only 1 in 5 Japanese children were voluntarily vaccinated. Those vaccinated received immunologic boosting from contact with children with natural chickenpox. But the mandatory vaccination program in the U.S. will nearly eradicate this natural boosting mechanism and leave our population vulnerable to shingles."
On May 26, 2006, the FDA approved Merck's shingles vaccine, ZOSTAVAX, for adults 60 years and older who have had chickenpox at some point in their lives. In October, 2006 the ACIP provisionally recommended it for all adults over 60 regardless of whether they did or did not have chickenpox. ZOSTAVAX is based on Merck's VARIVAX but is considered to be 14 times more potent. Cost for a single dose of ZOSTAVAX costs $150 or more.
The CDC recommendation that all American children get booster doses of chickenpox vaccine and all adults over 60 years old get a dose of shingles vaccine will generate billions of dollars for Merck, the sole supplier of chickenpox and shingles vaccine in the U.S.
Note: Gary Goldman has written several books about his experience as a varicella zoster vaccine researcher for the CDC and what happened when he attempted to inform the public about the vaccine's risks.
Click here for more information on Amazon.com
"Children between the ages of 8 and 12 years who had been vaccinated at least 5 years previously were significantly more likely to have moderate or severe disease than were those who had been vaccinated less than 5 years previously. The annual rate of breakthrough varicella significantly increased with the time since vaccination, from 1.6 cases per 1000 person-years within 1 year after vaccination to 9.0 per 1000 person-years at 5 years and 58.2 per 1000 person-years at 9 years." - Sandra Chavez, M.D. et al., New England Journal of Medicine
Loss of Vaccine-Induced Immunity to Varicella over Time, March 15, 2007
Barbara Loe Fisher Commentary:
In March 1995, when Merck's chickenpox vaccine, VARIVAX, was licensed, the National Vaccine Information Center issued a public statement and I appeared on NBC's "Today Show" questioning why the CDC and AAP were calling for mass use of the live varicella zoster vaccine by all healthy children. Originally developed for leukemic children for whom chicken pox could be deadly, it had taken Merck decades to get VARIVAX licensed for healthy children because it had such a high failure rate: efficacy was known to be 80 percent or less.
In 1995, NVIC went on record as opposing chicken pox vaccine mandates for the following reasons: (1) the childhood disease is highly communicable but mild for the vast majority of young children; (2) disease-induced immunity is qualitatively superior and lasts longer than vaccine induced, temporary immunity so mass vaccination sets up the need for booster shots; (3) mass vaccination will change the epidemiology of the disease and drive it into atypical older age groups where it is far more likely to cause permanent injury or death; (4) shingles cases may increase as chicken pox cases decrease.
On March 14, 2007, CDC officials published an article in the New England Journal of Medicine and confirmed the warning that NVIC issued exactly twelve years earlier: Merck's VARIVAX vaccine has a high failure rate and mass vaccination of American children has driven the disease into atypical older age groups where it can be far more dangerous. Already the CDC has said children between 4 and 6 years need a booster dose and a third booster may well be planned for teenagers..
And what about the chicken pox vaccine's safety? In September 2000, the FDA reported that in the first three years of the vaccine's use, 1 in 33,000 doses was followed by shock, convulsions, encephalitis, thrombocytopenia or death. About 82 percent of the adverse event reports to VAERS occurred in individuals who only received the chicken pox vaccine and led to the addition of 17 adverse events to the Merck product label, including secondary bacterial infections (cellulitis); secondary transmission (infection of close contacts); transverse myelitis; Guillain Barre syndrome and herpes zoster (shingles). On Sept. 13, 2000, NVIC issued a press release and stated "This vaccine should not be mandated. There are too many questions about the true adverse event and efficacy profile of this relatively new live virus vaccine and it is up to the manufacturer marketing the vaccine and the federal agencies regulating the vaccine to conduct further follow-up."
Since 2000, NVIC and VAERS have received continuing reports of brain inflammation, convulsions, vaccine strain chicken pox, shingles, regression into autism and other serious health problems following receipt of VARIVAX alone or in combination with MMR, DTaP, influenza, pneumococcal and other vaccines.
In the past few years, Gary S. Goldman, Ph.D., founder and editor of Medical Veritas, published research in Vaccine and the International Journal of Toxicology documenting an increase in shingles (herpes zoster) in the U.S. after the states mandated use of chickenpox vaccine following the CDC's 1995 "universal use" recommendation. Goldman's research revealed that shingles, a painful nerve inflammation and rash that develops into pus-filled blisters that break open and form scabs and can cause three times as many deaths and five times the number of hospitalizations as chicken pox, is suppressed naturally in a population when older children and adults have their chickenpox-induced immunity asymptomatically "boosted" by coming into contact with younger children infected with chicken pox. Dr. Goldman's findings, summarized in his article "The Case Against Universal Varicella Vaccination" (International Journal of Toxicology, 25:313-317, 2006) corroborate those of other independent researchers questioning the cost-benefit rationale for mandatory vaccination of all children with chickenpox vaccine.
Goldman and others have pointed out that, even if chickenpox was nearly eradicated by mass vaccination, the higher number of shingles cases could continue in the US for up to 50 years with any chickenpox deaths prevented by vaccination offset by deaths from increasing shingles disease. Goldman published a cost-benefit analysis of the mass varicella zoster vaccination program in Vaccine which demonstrated that the 50-year shingles epidemic will cost an excess $4.1 billion in health care costs to the U.S. According to Goldman, "The principal reason that chicken pox vaccines in Japan maintained high levels of immunity 20 years following vaccination was that only 1 in 5 Japanese children were voluntarily vaccinated. Those vaccinated received immunologic boosting from contact with children with natural chickenpox. But the mandatory vaccination program in the U.S. will nearly eradicate this natural boosting mechanism and leave our population vulnerable to shingles."
On May 26, 2006, the FDA approved Merck's shingles vaccine, ZOSTAVAX, for adults 60 years and older who have had chickenpox at some point in their lives. In October, 2006 the ACIP provisionally recommended it for all adults over 60 regardless of whether they did or did not have chickenpox. ZOSTAVAX is based on Merck's VARIVAX but is considered to be 14 times more potent. Cost for a single dose of ZOSTAVAX costs $150 or more.
The CDC recommendation that all American children get booster doses of chickenpox vaccine and all adults over 60 years old get a dose of shingles vaccine will generate billions of dollars for Merck, the sole supplier of chickenpox and shingles vaccine in the U.S.
Note: Gary Goldman has written several books about his experience as a varicella zoster vaccine researcher for the CDC and what happened when he attempted to inform the public about the vaccine's risks.
Click here for more information on Amazon.com
Vaccine Maker, Lawmakers Reject HPV Vaccine Mandates
"Giving it to 11-year-olds is a great big public health experiment," said Diane M. Harper, who is 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. "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.....So far more than 40 cases of Guillian-Barre syndrome - a dangerous immune disorder that causes tingling, numbness and even paralysis of the muscles have been reported in girls who have received the HPV vaccine in combination with the meningitis vaccine. Scientists already know that sometimes a vaccine can trigger the syndrome in a subject. "With the HPV vaccine, it is a small number but higher than is expected, and we don't know if it's the combination of the two, or the meningitis alone," Harper said." - Cindy Bevington, Fort Wayne Daily News (Indiana), March 14, 2007, Researcher Blasts HPV Marketing
"A State Senate panel has rejected a watered-down proposal, designed to encourage cervical cancer vaccinations for young girls. Lawmakers refused to approve a version that would only require doctors to tell parents about the shots. The original bill would have required sixth-grade girls to get the vaccination unless their parents signed a refusal form. Sponsor and Democratic Senator Suzanne Williams of Aurora scaled it back hoping to gain more support. But even the weaker version fell short. The Senate Appropriations Committee deadlocked on a 5- to-5 vote, so the bill will NOT move on to the full Senate." - Associated Press, KKTV-11 News (Colorado)HPV Vaccination Bill Fails
"A Georgia member of Congress yesterday introduced legislation to prohibit federal money from being used by states to make vaccines against the human papillomavirus (HPV) mandatory for school- age children. "Mandating the HPV vaccination is both unprecedented and unacceptable," said Rep. Phil Gingrey, a Republican, who is an obstetrician and gynecologist. "Whether or not girls get vaccinated against HPV is a decision for parents and physicians, not state governments." The Washington Times, March 16, 2007, Proposal Blocks Funding for HPV Vaccine
"Although no data exist on administration of quadrivalent HPV vaccine with vaccines other than hepatitis B vaccine, quadrivalent HPV vaccine is not a live vaccine and has no components that adversely impact safety or efficacy of other vaccinations. Quadrivalent HPV vaccine can be administered at the same visit as other age appropriate vaccines, such as the Tdap and quadrivalent meningococcal conjugate (MCV4) vaccines. Administering all indicated vaccines together at a single visit increases the likelihood that adolescents and young adults will receive each of the vaccines on schedule." - Lauri Markowitz, M.D. et al, ACIP, Morbidity & Mortality Report March 12, 2007
Barbara Loe Fisher Commentary:
The American people are speaking out about HPV vaccine mandates. In every public poll that is taken by the print or broadcast media, a majority of responders vote "NO" when asked if they want HPV vaccine mandates for sixth grade girls. Some state legislators have responded to the will of the people, like in Colorado, and have voted "No" to proposed mandates. A visionary physician member of the U.S. Congress, Georgia's Rep. Phil Gingrey, has introduced legislation to prohibit federal money from being used by states to mandate HPV vaccine. But other legislators, such as those in Virginia, have already quickly voted "yes" to HPV vaccine mandates. They apparently chose to listen to Merck rather than listening to the people who voted them into office.
While the people are saying "NO MANDATES" and the politicians are voting for or against mandates, NVIC continues to monitor GARDASIL adverse event reports being filed in VAERS, as well as counsel women and parents of daughters who suffered sudden collapse with seizure activity; pain, tingling, and numbness in hands; speech and vision loss and other serious health problems after being injected with GARDASIL.
Now, an HPV vaccine researcher has spoken out publicly in opposition to mandates, citing among other concerns the fact that there have been 40 cases of GBS reported after GARDASIL was given simultaneously with meningococcal vaccine. At the same time, the CDC published its official HPV vaccine recommendation in the Morbidity & Mortality Weekly Report, instructing doctors to give GARDASIL in combination with other vaccines, including meningococcal vaccine, even though they admit "no data exist on administration of quadrivalent HPV vaccine with vaccines other than hepatitis B vaccine...."
CDC officials associated with these recommendations are exhibiting an appalling lack of concern for individual and public health by cavalierly recommending that GARDASIL be given to every 11 year old girl in America, when they know that Merck only studied the vaccine in a few hundred 11 year old girls. This callous disregard for human life is compounded by telling doctors to give GARDASIL to little girls in combination with other vaccines when "no data exist" to support the safety of that policy.
Tragically, most doctors blindly trust the scientific validity of CDC vaccine recommendations. Many doctors refuse to report serious health problems suffered by children after vaccination because CDC officials have taught them to believe that vaccine associated health problems are a "coincidence" and have nothing to do with the vaccine(s) recently given to a child. Fewer than 10 percent of all doctors obey the safety provisions in the federal National Childhood Vaccine Injury Act of 1986, which includes mandatory reporting of vaccine adverse events because there are no sanctions for failing to report.
Just this week, a mother told NVIC that her daughter's doctor refused to report to VAERS that her daughter suffered a sudden collapse with seizure activity and other neurological signs within 30 minutes of being injected with GARDASIL. How many more doctors are refusing to report because they are in collective denial about vaccine risks?
The lesson that America is learning from the GARDASIL fiasco is that those who operate America's mass vaccination program arrogantly wield their considerable power by negligently putting policy before science and money before lives. There is about $4 billion dollars riding on the successful mandating of HPV vaccine for every girl in America, but trillions more riding on the precedent it will set.
The rollout of HPV vaccine today, marked by a callous indifference for minimizing vaccine injuries, is paving the way for the rollout of HIV vaccine tomorrow. One day soon the CDC and vaccine manufacturers will be telling the public that a little bit of the virus associated with AIDS injected into our children won't hurt them at all, especially if it is given with many other vaccines at the same time. They will try to politicize the ensuing debate by making it all about sex and poor kids not having access in order to try to divert attention from the lack of scientific proof the vaccine is safe and effective in children. The HIV vaccine ads will blanket the airwaves and editorials will call for pre-teens to line up and roll up their sleeves. Every state legislator in the country will be pressured to vote for school mandates.
And nobody will have a clue about just how dangerous that future HIV vaccine is for either individual or public health.
No forced vaccination. Not in America.
"A State Senate panel has rejected a watered-down proposal, designed to encourage cervical cancer vaccinations for young girls. Lawmakers refused to approve a version that would only require doctors to tell parents about the shots. The original bill would have required sixth-grade girls to get the vaccination unless their parents signed a refusal form. Sponsor and Democratic Senator Suzanne Williams of Aurora scaled it back hoping to gain more support. But even the weaker version fell short. The Senate Appropriations Committee deadlocked on a 5- to-5 vote, so the bill will NOT move on to the full Senate." - Associated Press, KKTV-11 News (Colorado)HPV Vaccination Bill Fails
"A Georgia member of Congress yesterday introduced legislation to prohibit federal money from being used by states to make vaccines against the human papillomavirus (HPV) mandatory for school- age children. "Mandating the HPV vaccination is both unprecedented and unacceptable," said Rep. Phil Gingrey, a Republican, who is an obstetrician and gynecologist. "Whether or not girls get vaccinated against HPV is a decision for parents and physicians, not state governments." The Washington Times, March 16, 2007, Proposal Blocks Funding for HPV Vaccine
"Although no data exist on administration of quadrivalent HPV vaccine with vaccines other than hepatitis B vaccine, quadrivalent HPV vaccine is not a live vaccine and has no components that adversely impact safety or efficacy of other vaccinations. Quadrivalent HPV vaccine can be administered at the same visit as other age appropriate vaccines, such as the Tdap and quadrivalent meningococcal conjugate (MCV4) vaccines. Administering all indicated vaccines together at a single visit increases the likelihood that adolescents and young adults will receive each of the vaccines on schedule." - Lauri Markowitz, M.D. et al, ACIP, Morbidity & Mortality Report March 12, 2007
Barbara Loe Fisher Commentary:
The American people are speaking out about HPV vaccine mandates. In every public poll that is taken by the print or broadcast media, a majority of responders vote "NO" when asked if they want HPV vaccine mandates for sixth grade girls. Some state legislators have responded to the will of the people, like in Colorado, and have voted "No" to proposed mandates. A visionary physician member of the U.S. Congress, Georgia's Rep. Phil Gingrey, has introduced legislation to prohibit federal money from being used by states to mandate HPV vaccine. But other legislators, such as those in Virginia, have already quickly voted "yes" to HPV vaccine mandates. They apparently chose to listen to Merck rather than listening to the people who voted them into office.
While the people are saying "NO MANDATES" and the politicians are voting for or against mandates, NVIC continues to monitor GARDASIL adverse event reports being filed in VAERS, as well as counsel women and parents of daughters who suffered sudden collapse with seizure activity; pain, tingling, and numbness in hands; speech and vision loss and other serious health problems after being injected with GARDASIL.
Now, an HPV vaccine researcher has spoken out publicly in opposition to mandates, citing among other concerns the fact that there have been 40 cases of GBS reported after GARDASIL was given simultaneously with meningococcal vaccine. At the same time, the CDC published its official HPV vaccine recommendation in the Morbidity & Mortality Weekly Report, instructing doctors to give GARDASIL in combination with other vaccines, including meningococcal vaccine, even though they admit "no data exist on administration of quadrivalent HPV vaccine with vaccines other than hepatitis B vaccine...."
CDC officials associated with these recommendations are exhibiting an appalling lack of concern for individual and public health by cavalierly recommending that GARDASIL be given to every 11 year old girl in America, when they know that Merck only studied the vaccine in a few hundred 11 year old girls. This callous disregard for human life is compounded by telling doctors to give GARDASIL to little girls in combination with other vaccines when "no data exist" to support the safety of that policy.
Tragically, most doctors blindly trust the scientific validity of CDC vaccine recommendations. Many doctors refuse to report serious health problems suffered by children after vaccination because CDC officials have taught them to believe that vaccine associated health problems are a "coincidence" and have nothing to do with the vaccine(s) recently given to a child. Fewer than 10 percent of all doctors obey the safety provisions in the federal National Childhood Vaccine Injury Act of 1986, which includes mandatory reporting of vaccine adverse events because there are no sanctions for failing to report.
Just this week, a mother told NVIC that her daughter's doctor refused to report to VAERS that her daughter suffered a sudden collapse with seizure activity and other neurological signs within 30 minutes of being injected with GARDASIL. How many more doctors are refusing to report because they are in collective denial about vaccine risks?
The lesson that America is learning from the GARDASIL fiasco is that those who operate America's mass vaccination program arrogantly wield their considerable power by negligently putting policy before science and money before lives. There is about $4 billion dollars riding on the successful mandating of HPV vaccine for every girl in America, but trillions more riding on the precedent it will set.
The rollout of HPV vaccine today, marked by a callous indifference for minimizing vaccine injuries, is paving the way for the rollout of HIV vaccine tomorrow. One day soon the CDC and vaccine manufacturers will be telling the public that a little bit of the virus associated with AIDS injected into our children won't hurt them at all, especially if it is given with many other vaccines at the same time. They will try to politicize the ensuing debate by making it all about sex and poor kids not having access in order to try to divert attention from the lack of scientific proof the vaccine is safe and effective in children. The HIV vaccine ads will blanket the airwaves and editorials will call for pre-teens to line up and roll up their sleeves. Every state legislator in the country will be pressured to vote for school mandates.
And nobody will have a clue about just how dangerous that future HIV vaccine is for either individual or public health.
No forced vaccination. Not in America.
HPV Mandate Debate Continues
Since we don't consider our children alley cats or any danger to public health, we reserve the right to make decisions about each and every invasive medical procedure including all vaccines. Kentucky politicians must think we are too inept to be granted that right as parents. Now that Kentucky legislators are allowed to behave like Stalin in promoting corporate agendas for non-contagious diseases, the ball is rolling downhill for intrusion into all realms of personal choice. Since Kentucky schools are no longer an option for my children to return to, I intend to move out of state with them." - Doreen Carlson, Central Kentucky News-Journal , March 12, 2007, Vaccine Has Forced Me Out of State
"We are not against vaccine availability, just vaccine mandates," says Fisher. While she concedes that every state but two has some kind of opt-out clause for parents who object to the vaccine for health, religious, moral or ethical reasons, she says parents who refuse immunization are harassed. "Your name goes on a state list. You get harassing calls from the CDC for your views on vaccines. Some families get thrown off health insurance plans, thrown out of their pediatricians' offices, thrown out of public schools — or parents are put in a room and grilled by officials about the depth of their religious convictions on this." - Karen Houppert, The Nation, also CBS News.com, March 11, 2007, The Fight Against Mandating An HPV Vaccine Has Made Strange Bedfellows Of Many Groups
"With such widespread HPV infection, a vaccination plan might seem like a reasonable idea. The issue takes on a special significance in our home because we have a 13-year-old daughter. But while we did conclude that the vaccine is right for our daughter, I think the decision to vaccinate a child with this particular vaccine should be made by the patient, her parents and their doctor. Not the state." - Benjamin Brewer, M.D., Wall Street Journal , March 8, 2007, Why Mandatory Vaccine May Not Be the Answer
Barbara Loe Fisher Commentary:
The intense public debate about whether the state should force parents to inject their adolescent daughters with a poorly tested and potentially unsafe vaccine to prevent an infection that cannot be transmitted in the public setting rages on while legislators in 36 states either fast track, amend, table, withdraw or rescind HPV vaccine mandates.
In Texas, the House of Representatives today voted 119 to 21 to prohibit an HPV vaccine mandate in Texas, effectively rescinding Rick Perry's Feb. 2 Executive Order mandating the vaccine for girls entering sixth grade (for more information on what is happening in Texas, go to www.vaccineinfo.net ) In Virginia and New Mexico, legislators have recently sent HPV vaccine mandates to their Governor's desks for signing. (To find out what your state is doing, go to www.nvic.org, click on "HPV Infection and Gardasil" on the homepage and then click on "Check Proposed HPV Vaccine Mandates in Your State")
The majority of Americans do not want state governments forcing their 11 year old daughters to get three doses of HPV vaccine in order to attend sixth grade. Most Americans support the availability of the HPV vaccine with no cost or access barriers to those parents who want their daughters to get the vaccine but they do not support HPV vaccine mandates.
America's mandatory vaccination system is in critical need of reform. The National Vaccine Information Center has been working for 25 years to institute safety and informed consent protections in America's vaccination system. It is time for federal and state public health officials, the pharmaceutical industry and physician organizations to listen to the people. A system that will not bend will break.
"We are not against vaccine availability, just vaccine mandates," says Fisher. While she concedes that every state but two has some kind of opt-out clause for parents who object to the vaccine for health, religious, moral or ethical reasons, she says parents who refuse immunization are harassed. "Your name goes on a state list. You get harassing calls from the CDC for your views on vaccines. Some families get thrown off health insurance plans, thrown out of their pediatricians' offices, thrown out of public schools — or parents are put in a room and grilled by officials about the depth of their religious convictions on this." - Karen Houppert, The Nation, also CBS News.com, March 11, 2007, The Fight Against Mandating An HPV Vaccine Has Made Strange Bedfellows Of Many Groups
"With such widespread HPV infection, a vaccination plan might seem like a reasonable idea. The issue takes on a special significance in our home because we have a 13-year-old daughter. But while we did conclude that the vaccine is right for our daughter, I think the decision to vaccinate a child with this particular vaccine should be made by the patient, her parents and their doctor. Not the state." - Benjamin Brewer, M.D., Wall Street Journal , March 8, 2007, Why Mandatory Vaccine May Not Be the Answer
Barbara Loe Fisher Commentary:
The intense public debate about whether the state should force parents to inject their adolescent daughters with a poorly tested and potentially unsafe vaccine to prevent an infection that cannot be transmitted in the public setting rages on while legislators in 36 states either fast track, amend, table, withdraw or rescind HPV vaccine mandates.
In Texas, the House of Representatives today voted 119 to 21 to prohibit an HPV vaccine mandate in Texas, effectively rescinding Rick Perry's Feb. 2 Executive Order mandating the vaccine for girls entering sixth grade (for more information on what is happening in Texas, go to www.vaccineinfo.net ) In Virginia and New Mexico, legislators have recently sent HPV vaccine mandates to their Governor's desks for signing. (To find out what your state is doing, go to www.nvic.org, click on "HPV Infection and Gardasil" on the homepage and then click on "Check Proposed HPV Vaccine Mandates in Your State")
The majority of Americans do not want state governments forcing their 11 year old daughters to get three doses of HPV vaccine in order to attend sixth grade. Most Americans support the availability of the HPV vaccine with no cost or access barriers to those parents who want their daughters to get the vaccine but they do not support HPV vaccine mandates.
America's mandatory vaccination system is in critical need of reform. The National Vaccine Information Center has been working for 25 years to institute safety and informed consent protections in America's vaccination system. It is time for federal and state public health officials, the pharmaceutical industry and physician organizations to listen to the people. A system that will not bend will break.
HPV Vaccine Order Unleashes Parents Anger
"Health experts are dismayed by the controversy over Merck's Gardasil, which protects against two common forms of the sexually transmitted virus that causes cervical cancer. But it has hardly surprised them. Never has compulsory use of a drug been pushed with such breakneck speed -- with concerted lobbying by its manufacturer...."Why is this happening so fast? Why is there a mandate when this is such a different kind of disease?" asked Barbara Loe Fisher, president of the National Vaccine Information Center, a nonprofit consumer organization that opposes HPV legislation. Most states did not add the chickenpox vaccine to schoolchildren's immunization schedules until several years after its approval in the mid-1990s, she noted." - Susan Levine, Washington Post , March 4, 2007, Parents Question HPV Vaccine
"More than 5,900 e-mails and printed notes have been sent to Perry about his Feb. 2 executive order that girls entering the sixth grade in 2008 be vaccinated against the human papilloma virus, which causes most cases of cervical cancer...."Please, reconsider. Please, return parental choices, control, power to parents," wrote Bette D. Bittner of Caldwell. Ned Funnell of Longview also told Perry the decision to vaccinate belongs to parents, not the state.....of the e- mails and letters on the vaccine received by the governor's office as of Tuesday, 89 percent opposed his order, while 11 percent favored it......Most of the e- mails and letters on the cervical cancer vaccine were from Texans, with about 1,500 coming from out of state...." - Kelly Shannon, Associated Press March 7, 2007, Vaccine Order Unleases Flood of Anger
" I am happy our Senate [Indiana] chose to scale down the legislation before they approved it and not make the vaccine mandatory for young girls across the state. Legislation that makes it mandatory, I believe, takes away a parent's right but also the child's choice to get the vaccine, especially when the side effects of the vaccine hasn't been studied for any lengthy period of time. Who knows what disastrous side effects the vaccine could have. I'm not sure if it is worth the risk....A vaccine against HPV to prevent cervical cancer isn't the only answer, and only time will tell whether it is even an answer at all. However, I do know there are many more damaging killers in the world that should be getting the attention that Merck and Gardasil have brought to cervical cancer." - Tonya Windell, Corydon Democrat Gardasil Vaccine Should Be Parent's Choice, March 7, 2007
Barbara Loe Fisher Commentary:
There is a message that is being sent by parents to the Centers for Disease Control, drug companies, medical organizations and legislators in every state in response to proposed HPV vaccine mandates: we are not going to sit back and watch more vaccines be added to the long list of mandatory vaccinations for our children without having something to say about it. Parents, who have never questioned vaccine mandates before, joined with parents, who have been questioning vaccine mandates for a long time, and have drawn a line in the sand on forced vaccination with a vaccine that has not been proven safe in little girls for an infection that cannot be transmitted in the school setting.
For 25 years, the National Vaccine Information has been a strong advocate for the right to informed consent to vaccination as part of a broader national campaign to prevent vaccine injuries and deaths through public education. We have long questioned why, every time the pharmaceutical industry produces a new vaccine, it is automatically recommended for universal use by the CDC and AAP and automatically added by states to the mandatory list of vaccines required for children to get an education.
It has never been a secret to those of us working with parents, who have difficulty obtaining medical, religious and conscientious belief exemptions to vaccination, that drug companies, public health officials and medical organizations lobby hard to get new vaccines mandated. Thanks to Merck's heavy handed lobbying efforts using a Merck-funded "non- profit" organization to carry out its blitzkrieg introduction of HPV vaccine mandates in several dozen states, the whole nation now understands that new vaccine mandates are powered by the CDC's "universal use" recommendations and drug company-financed lobbying campaigns.
After a quarter century of remaining underground, the debate about state-forced vaccination is now taking place publicly. Much to the surprise of many doctors and lawmakers, a majority of parents across the country are standing up and saying "Show us the science and give us a choice." Mothers and fathers of vaccine injured children, who learned the hard way just how important it is to make well informed vaccine choices, are not surprised at all.
"More than 5,900 e-mails and printed notes have been sent to Perry about his Feb. 2 executive order that girls entering the sixth grade in 2008 be vaccinated against the human papilloma virus, which causes most cases of cervical cancer...."Please, reconsider. Please, return parental choices, control, power to parents," wrote Bette D. Bittner of Caldwell. Ned Funnell of Longview also told Perry the decision to vaccinate belongs to parents, not the state.....of the e- mails and letters on the vaccine received by the governor's office as of Tuesday, 89 percent opposed his order, while 11 percent favored it......Most of the e- mails and letters on the cervical cancer vaccine were from Texans, with about 1,500 coming from out of state...." - Kelly Shannon, Associated Press March 7, 2007, Vaccine Order Unleases Flood of Anger
" I am happy our Senate [Indiana] chose to scale down the legislation before they approved it and not make the vaccine mandatory for young girls across the state. Legislation that makes it mandatory, I believe, takes away a parent's right but also the child's choice to get the vaccine, especially when the side effects of the vaccine hasn't been studied for any lengthy period of time. Who knows what disastrous side effects the vaccine could have. I'm not sure if it is worth the risk....A vaccine against HPV to prevent cervical cancer isn't the only answer, and only time will tell whether it is even an answer at all. However, I do know there are many more damaging killers in the world that should be getting the attention that Merck and Gardasil have brought to cervical cancer." - Tonya Windell, Corydon Democrat Gardasil Vaccine Should Be Parent's Choice, March 7, 2007
Barbara Loe Fisher Commentary:
There is a message that is being sent by parents to the Centers for Disease Control, drug companies, medical organizations and legislators in every state in response to proposed HPV vaccine mandates: we are not going to sit back and watch more vaccines be added to the long list of mandatory vaccinations for our children without having something to say about it. Parents, who have never questioned vaccine mandates before, joined with parents, who have been questioning vaccine mandates for a long time, and have drawn a line in the sand on forced vaccination with a vaccine that has not been proven safe in little girls for an infection that cannot be transmitted in the school setting.
For 25 years, the National Vaccine Information has been a strong advocate for the right to informed consent to vaccination as part of a broader national campaign to prevent vaccine injuries and deaths through public education. We have long questioned why, every time the pharmaceutical industry produces a new vaccine, it is automatically recommended for universal use by the CDC and AAP and automatically added by states to the mandatory list of vaccines required for children to get an education.
It has never been a secret to those of us working with parents, who have difficulty obtaining medical, religious and conscientious belief exemptions to vaccination, that drug companies, public health officials and medical organizations lobby hard to get new vaccines mandated. Thanks to Merck's heavy handed lobbying efforts using a Merck-funded "non- profit" organization to carry out its blitzkrieg introduction of HPV vaccine mandates in several dozen states, the whole nation now understands that new vaccine mandates are powered by the CDC's "universal use" recommendations and drug company-financed lobbying campaigns.
After a quarter century of remaining underground, the debate about state-forced vaccination is now taking place publicly. Much to the surprise of many doctors and lawmakers, a majority of parents across the country are standing up and saying "Show us the science and give us a choice." Mothers and fathers of vaccine injured children, who learned the hard way just how important it is to make well informed vaccine choices, are not surprised at all.
Will VA Governor Mandate HPV Vaccine?
"Gov. Timothy M. Kaine expressed concern Tuesday about legislation that would require young girls to be vaccinated against the sexually transmitted human papillomavirus. “The challenge is, Should we mandate it? We mandate a lot of vaccines for school children,” [Kaine] said. “We don’t want them to infect each other with infectious diseases. This kind of goes an additional step, because it’s not something that we’re mandating to stop infection among school kids.....So the thing I’m going to look at on this bill is the ability for parents and youngsters to opt out of the mandate. Is it a generous, kind of wide-ranging opt-out?” he asked.... Barbara Loe Fisher , president and co-founder of the National Vaccine Information Center, advocates giving parents the right to opt in rather than opt out of mandates. “I don’t think a lot of people understand that they do actually have the opt-out option,” Fisher said. Families, she added, “should be able to make an informed and voluntary decision......“I really hope that the governor of Virginia carefully examines what this is going to cost Virginia to mandate this vaccine for every 11-year-old girl,” Fisher said. “It could be a very costly mistake.” - Amy Coutee, Virginian-Pilot, Feb. 28, 2007
"Del. Phillip A. Hamilton (R-Newport News), sponsor of the legislation, said he is not sure how the governor could make the opt-out provision any stronger. "Right now, parents are given information, and if they choose not to do it, they don't have to do it. They just have to sign a form so the health department knows they opted out," Hamilton said. "I just don't know how much broader you can make it." Merck and Co., a New Jersey- based pharmaceutical maker, received federal approval in June to sell the vaccine, which is called Gardasil. Merck then began a nationwide lobbying campaign to try to get states to mandate the vaccine. At least 20 states are considering doing so. But Merck suspended the campaign two weeks ago amid questions about whether profit, rather than public health, is guiding the debate. Concerns have also been raised about potential side effects." - Tim Craig, Washington Post, Feb. 28, 2007
"Virginia's governor says he will sign legislation requiring pre-teen female students to be vaccinated against the sexually transmitted virus that can cause cervical cancer. Virginia would become the second state to mandate the vaccine for the human papillomavirus, or HPV, and the first to do it through legislative action. The governor of Texas sidestepped the Legislature and ordered the shots for girls there, but lawmakers are considering overriding that order." - Associated Press, March 1, 2007
"Governor Timothy M. Kaine today announced that Merck & Co., Inc. will invest $57 million to expand the role its Elkton facility plays in producing GARDASIL®, Merck’s cervical cancer vaccine.....This announcement not only increases Merck’s investment in Virginia, it provides a vital vaccine for women’s health,” said Governor Kaine. “Implementing this new process at the Elkton plant shows the confidence Merck has in Virginia’s positive business climate and dedicated workforce....The company’s Elkton facility employs more than 700 people with $60 million in annual payroll....Governor Kaine approved a $700,000 performance-based grant from the Virginia Investment Partnership (VIP) program, an incentive available to existing Virginia companies." - December 14, 2006 Press Release, Office of Virginia Governor Tim Kaine
Barbara Loe Fisher Commentary:
Three days ago (Feb. 28) Governor Tim Kaine (D) justifiably expressed concern about signing a bill that mandates every 11 year old girl living in Virginia get HPV vaccine before attending sixth grade. He said he was worried about the fact that HPV infection was not transmitted in the school setting and that "we mandate a lot of vaccines for school children"and that "the opt- out provision to protect kids and parents should be generous" so parents "don't have to jump through hoops" to opt-out of the mandate. Today (Mar. 2), Associated Press is reporting that Governor Kaine will sign the bill without amending it, making Virginia the first state to mandate HPV vaccine after going through the state legislature rather than by executive order a la Texas Governor Rick Perry. Hopefully, this is just an unconfirmed rumor and that Gov. Kaine will not compel Virginia taxpayers to spend millions of dollars to purchase Merck's HPV vaccine, GARDASIL, in an attempt to prevent less than one quarter of one percent of women, who may become chronically infected with HPV and fail to be diagnosed with pap screens, from getting cervical cancer.
Earlier this week the CDC published new HPV infection prevalence data which revealed that one quarter of all American girls and women aged 14 to 59 years are infected with HPV of any type. However, only 2 percent of them are infected with HPV types 16 and 18, which are the only high risk HPV types associated with cervical cancer included in Merck's GARDASIL. (Most sexually active individuals become asymptomatically infected with HPV at some point in their lives but 90 percent clear the infection from their bodies. Among high risk factors for chronic HPV infection are co-infection with herpes, chlamydia and HIV; smoking; long term oral contraceptive use; multiple births and poverty.)
It is well known that Merck campaign contributions coincided with a Feb. 2, 2007 Executive Order by the Governor of Texas that mandated the vaccine for all little girls in Texas. Less well known is the fact that on Dec. 14, 2006, Merck announced a $57 million dollar expansion of its plant in Elkton, Virginia (with an annual payroll of $60 million) to produce GARDASIL. Gov. Kaine approved a $700,000 performance-based grant from the Virginia Investment Partnership (VIP) program for Merck to improve the Elkton plant to make it ready to produce GARDASIL ( Click here to view the Dec 14, 2006 Press Release)
Although Gov. Kaine and many of the Virginia legislators sponsoring the HPV vaccine mandate for all little girls in Virginia may have consulted their consciences in making this decision for Virginia families, unfortunately Virginia politicians appear to have something in common with the Governor of Texas: financial incentive from Merck to vote for an HPV vaccine mandate. When citizens look at new vaccine mandates like this one, they see the heavy hand of the pharmaceutical industry influencing public health policy in America.
Parents are growing weary of watching lawmakers add every new vaccine that industry produces for children to state vaccine laws. Why are our schools becoming centers for forced vaccination rather than centers for education? Why should parents and their children be placed on a government monitored List of names identifying those who "opt- out" of getting HPV vaccine? What will it mean in the future to have your name and your child's name on that List? Whose business is it if parents choose not to give their 11 year old daughters a vaccine for a sexually transmitted disease that cannot be transmitted in the school classroom?
There is too little known about the safety and potential long term effectiveness of HPV vaccine to mandate it for anyone. Lawmakers who vote to mandate this vaccine will have made a mistake, which may cost them and the citizens of their states dearly.
"Del. Phillip A. Hamilton (R-Newport News), sponsor of the legislation, said he is not sure how the governor could make the opt-out provision any stronger. "Right now, parents are given information, and if they choose not to do it, they don't have to do it. They just have to sign a form so the health department knows they opted out," Hamilton said. "I just don't know how much broader you can make it." Merck and Co., a New Jersey- based pharmaceutical maker, received federal approval in June to sell the vaccine, which is called Gardasil. Merck then began a nationwide lobbying campaign to try to get states to mandate the vaccine. At least 20 states are considering doing so. But Merck suspended the campaign two weeks ago amid questions about whether profit, rather than public health, is guiding the debate. Concerns have also been raised about potential side effects." - Tim Craig, Washington Post, Feb. 28, 2007
"Virginia's governor says he will sign legislation requiring pre-teen female students to be vaccinated against the sexually transmitted virus that can cause cervical cancer. Virginia would become the second state to mandate the vaccine for the human papillomavirus, or HPV, and the first to do it through legislative action. The governor of Texas sidestepped the Legislature and ordered the shots for girls there, but lawmakers are considering overriding that order." - Associated Press, March 1, 2007
"Governor Timothy M. Kaine today announced that Merck & Co., Inc. will invest $57 million to expand the role its Elkton facility plays in producing GARDASIL®, Merck’s cervical cancer vaccine.....This announcement not only increases Merck’s investment in Virginia, it provides a vital vaccine for women’s health,” said Governor Kaine. “Implementing this new process at the Elkton plant shows the confidence Merck has in Virginia’s positive business climate and dedicated workforce....The company’s Elkton facility employs more than 700 people with $60 million in annual payroll....Governor Kaine approved a $700,000 performance-based grant from the Virginia Investment Partnership (VIP) program, an incentive available to existing Virginia companies." - December 14, 2006 Press Release, Office of Virginia Governor Tim Kaine
Barbara Loe Fisher Commentary:
Three days ago (Feb. 28) Governor Tim Kaine (D) justifiably expressed concern about signing a bill that mandates every 11 year old girl living in Virginia get HPV vaccine before attending sixth grade. He said he was worried about the fact that HPV infection was not transmitted in the school setting and that "we mandate a lot of vaccines for school children"and that "the opt- out provision to protect kids and parents should be generous" so parents "don't have to jump through hoops" to opt-out of the mandate. Today (Mar. 2), Associated Press is reporting that Governor Kaine will sign the bill without amending it, making Virginia the first state to mandate HPV vaccine after going through the state legislature rather than by executive order a la Texas Governor Rick Perry. Hopefully, this is just an unconfirmed rumor and that Gov. Kaine will not compel Virginia taxpayers to spend millions of dollars to purchase Merck's HPV vaccine, GARDASIL, in an attempt to prevent less than one quarter of one percent of women, who may become chronically infected with HPV and fail to be diagnosed with pap screens, from getting cervical cancer.
Earlier this week the CDC published new HPV infection prevalence data which revealed that one quarter of all American girls and women aged 14 to 59 years are infected with HPV of any type. However, only 2 percent of them are infected with HPV types 16 and 18, which are the only high risk HPV types associated with cervical cancer included in Merck's GARDASIL. (Most sexually active individuals become asymptomatically infected with HPV at some point in their lives but 90 percent clear the infection from their bodies. Among high risk factors for chronic HPV infection are co-infection with herpes, chlamydia and HIV; smoking; long term oral contraceptive use; multiple births and poverty.)
It is well known that Merck campaign contributions coincided with a Feb. 2, 2007 Executive Order by the Governor of Texas that mandated the vaccine for all little girls in Texas. Less well known is the fact that on Dec. 14, 2006, Merck announced a $57 million dollar expansion of its plant in Elkton, Virginia (with an annual payroll of $60 million) to produce GARDASIL. Gov. Kaine approved a $700,000 performance-based grant from the Virginia Investment Partnership (VIP) program for Merck to improve the Elkton plant to make it ready to produce GARDASIL ( Click here to view the Dec 14, 2006 Press Release)
Although Gov. Kaine and many of the Virginia legislators sponsoring the HPV vaccine mandate for all little girls in Virginia may have consulted their consciences in making this decision for Virginia families, unfortunately Virginia politicians appear to have something in common with the Governor of Texas: financial incentive from Merck to vote for an HPV vaccine mandate. When citizens look at new vaccine mandates like this one, they see the heavy hand of the pharmaceutical industry influencing public health policy in America.
Parents are growing weary of watching lawmakers add every new vaccine that industry produces for children to state vaccine laws. Why are our schools becoming centers for forced vaccination rather than centers for education? Why should parents and their children be placed on a government monitored List of names identifying those who "opt- out" of getting HPV vaccine? What will it mean in the future to have your name and your child's name on that List? Whose business is it if parents choose not to give their 11 year old daughters a vaccine for a sexually transmitted disease that cannot be transmitted in the school classroom?
There is too little known about the safety and potential long term effectiveness of HPV vaccine to mandate it for anyone. Lawmakers who vote to mandate this vaccine will have made a mistake, which may cost them and the citizens of their states dearly.
ACIP Chair Says, "No HPV Mandate"
"We have endorsed a mandate because the vaccine — Merck’s Gardasil — looks highly effective against strains that cause 70 percent of all cervical cancer....The strongest arguments against moving ahead quickly tend to be practical and financial. States have typically used school mandates for vaccines that are already in wide use, and it is possible that unexpected side effects could emerge (though any mandate could be suspended if that happened). Health professionals also need to be certain that there are stable supplies, adequate insurance coverage, ample public money to vaccinate low-income children and physician support." - Editorial, The New York Times (Feb. 26)
"The chairman of the federal panel that recommended the new cervical-cancer vaccine for pre- teen girls says lawmakers should not make the inoculation mandatory, as the District and more than 20 states, including Virginia, are considering. Jon Abramson, chairman of the Centers for Disease Control and Prevention's advisory committee on immunization practices (ACIP), also said he and panel members told Merck & Co., the drug Gardasil's maker, not to lobby state lawmakers to require the vaccine for school attendance. "I told Merck my personal opinion that it shouldn't be mandated," Dr. Abramson told The Washington Times. "And they heard it from other committee members."...... ACIP is the only entity in the federal government to issue immunization recommendations and does not recommend a vaccine be made mandatory; those decisions are left to the states. But the committee's recommendation on the use of a vaccine often plays the lead role in whether states will act to make it part of their mandatory vaccine list, said Barbara Fisher, president of the National Vaccine Information Center, which is opposed to laws making Gardasil mandatory. "They are the signal for states to act," she said. "The committee knows that and I think they see people getting upset about it." - Gregory Lopes, The Washington Times (Feb. 27)
"Based on this analysis, Dunne et al found the overall prevalence of HPV (any type) infection was 26.8% in females 14 through 59 years of age....the combined prevalence of [vaccine types] HPV-6, HPV- 11, HPV-16 and HPV-18 was 3.4%....the combined prevalence of the 2 high-risk types, HPV-16 and HPV- 18 [most associated with cervical cancer] was approximately 2%....Follow-up prevalence studies will be important not only to evaluate [quadrivalent HPV] vaccine effectiveness but also to address the question of whether other high-risk oncogenic HPV types will fill the ecological niche created by the expected decline in HPV-16 and HPV-18. Studies of cost-effectiveness of the vaccine have used HPV prevalence estimates from selected populations, including some outside of the United States. Now it will be important to assess the cost-effectiveness of the vaccine using these new prevalence data from US females." - Editorial, JAMA (Feb. 28)
"Even among women most likely to be infected - sexually active 18- to 25-year-olds - these two cancer-causing HPV strains were relatively uncommon, infecting 3.5 percent. Experts say these findings, published today, do not change the conclusion that the public-health benefits of vaccination are worth the cost. But the new data may create confusion and fuel controversy over whether to mandate inoculation of pubescent girls. At least 20 states are considering proposals. The study supports the notion that there should not be a "rush to make this vaccine mandatory," said Kenneth Chaiken, a Dallas lawyer representing six parents who are suing the Texas governor over his order requiring vaccination of sixth-grade girls. Barbara Loe Fisher, president of the National Vaccine Information Center, a nonprofit advocacy group that contends all vaccines pose risks the public is not warned about, said she was "shocked" by the new data. "This is not what most people in America who have looked at publicity for this vaccine were led to believe," she said." - Marie McCullough, Philadelphia Inquirer (Feb 28)
Barbara Loe Fisher Commentary:
A study was published in today's Journal of the American Medical Association (JAMA) estimating the population prevalence of HPV infection in American women aged 14 to 59 years old. What the CDC study authors found was an overall prevalence of HPV (any type) infection in 26.8 % of the American females studied, with 3.4% infected with one of the four HPV types in Merck's quadrivalent vaccine and 2% infected with one of the two vaccine types (HPV 16 and 18) associated with cervical cancer. The study noted that 90 percent of all HPV infections are cleared from the body and do not become chronic. This means that less than one quarter of one percent of all American women are at risk for chronic infection with one of the two HPV types associated with cervical cancer which are contained in Merck's GARDASIL vaccine.
These new HPV prevalence data seriously call into question the cost benefit ratio for GARDASIL, particularly when taking into account short and long term serious vaccine reactions being reported to the Vaccine Adverse Event Reporting System (VAERS), such as five cases of Guillain Barre Syndrome (GBS) and cases of syncope with seizures, facial paralysis and other signs of brain and immune system dysfunction. The Editorial in JAMA also questioned whether the two HPV types in the vaccine would be replaced by the other HPV types associated with cervical cancer, limiting the vaccine's effectiveness. On May 18, 2006, the FDA staff questioned this possibility, as did NVIC in its Feb. 24, 2007 press release ( go to www.nvic.org).
The Washington Times reports that ACIP chairman Jon Abramson and other committee members did not want GARDASIL mandated. If this is true, then ACIP should have stated that fact clearly when they made their recommendation in the summer of 2006 that all 11 year old girls get the vaccine. In light of newly published HPV prevalence data and the fact that Merck only studied GARDASIL in a few hundred eleven year old girls for a few years, together with reports of serious adverse events such as GBS coming into VAERS, the CDC's ACIP members should be more worried about unanimously recommending GARDASIL for routine use with inadequate supporting evidence.
Finally, The New York Times came out with another editorial endorsing the HPV vaccine mandates, despite the growing list of outstanding scientific questions about the vaccine's necessity, safety and effectiveness. The New York Times is behind the times with its knee jerk endorsement of school mandates for this vaccine. Whoever wrote the editorial is particularly cruel to endorse mandates while acknowledging that "it is possible that unexpected side effects could emerge, though any mandate could be suspended if that happened." Is the New York Times editorial staff going to take responsibility for the children who are required to take GARDASIL and suffer serious side effects already reported to VAERS, or the children who will be injured if it is eventually revealed that GARDASIL has more "unexpected side effects?" American children should not be viewed as guinea pigs by drug companies, health officials, doctors, politicians or newspaper editors.
To hear a 30 minute interview explaining the scientific and policy issues relating to proposed HPV vaccine mandates, listen to a tape of the Feb. 22 Brian Lehrer show on WNYC radio entitled "Strange Bedfellows". Describing the show, WNYC says "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."
"The chairman of the federal panel that recommended the new cervical-cancer vaccine for pre- teen girls says lawmakers should not make the inoculation mandatory, as the District and more than 20 states, including Virginia, are considering. Jon Abramson, chairman of the Centers for Disease Control and Prevention's advisory committee on immunization practices (ACIP), also said he and panel members told Merck & Co., the drug Gardasil's maker, not to lobby state lawmakers to require the vaccine for school attendance. "I told Merck my personal opinion that it shouldn't be mandated," Dr. Abramson told The Washington Times. "And they heard it from other committee members."...... ACIP is the only entity in the federal government to issue immunization recommendations and does not recommend a vaccine be made mandatory; those decisions are left to the states. But the committee's recommendation on the use of a vaccine often plays the lead role in whether states will act to make it part of their mandatory vaccine list, said Barbara Fisher, president of the National Vaccine Information Center, which is opposed to laws making Gardasil mandatory. "They are the signal for states to act," she said. "The committee knows that and I think they see people getting upset about it." - Gregory Lopes, The Washington Times (Feb. 27)
"Based on this analysis, Dunne et al found the overall prevalence of HPV (any type) infection was 26.8% in females 14 through 59 years of age....the combined prevalence of [vaccine types] HPV-6, HPV- 11, HPV-16 and HPV-18 was 3.4%....the combined prevalence of the 2 high-risk types, HPV-16 and HPV- 18 [most associated with cervical cancer] was approximately 2%....Follow-up prevalence studies will be important not only to evaluate [quadrivalent HPV] vaccine effectiveness but also to address the question of whether other high-risk oncogenic HPV types will fill the ecological niche created by the expected decline in HPV-16 and HPV-18. Studies of cost-effectiveness of the vaccine have used HPV prevalence estimates from selected populations, including some outside of the United States. Now it will be important to assess the cost-effectiveness of the vaccine using these new prevalence data from US females." - Editorial, JAMA (Feb. 28)
"Even among women most likely to be infected - sexually active 18- to 25-year-olds - these two cancer-causing HPV strains were relatively uncommon, infecting 3.5 percent. Experts say these findings, published today, do not change the conclusion that the public-health benefits of vaccination are worth the cost. But the new data may create confusion and fuel controversy over whether to mandate inoculation of pubescent girls. At least 20 states are considering proposals. The study supports the notion that there should not be a "rush to make this vaccine mandatory," said Kenneth Chaiken, a Dallas lawyer representing six parents who are suing the Texas governor over his order requiring vaccination of sixth-grade girls. Barbara Loe Fisher, president of the National Vaccine Information Center, a nonprofit advocacy group that contends all vaccines pose risks the public is not warned about, said she was "shocked" by the new data. "This is not what most people in America who have looked at publicity for this vaccine were led to believe," she said." - Marie McCullough, Philadelphia Inquirer (Feb 28)
Barbara Loe Fisher Commentary:
A study was published in today's Journal of the American Medical Association (JAMA) estimating the population prevalence of HPV infection in American women aged 14 to 59 years old. What the CDC study authors found was an overall prevalence of HPV (any type) infection in 26.8 % of the American females studied, with 3.4% infected with one of the four HPV types in Merck's quadrivalent vaccine and 2% infected with one of the two vaccine types (HPV 16 and 18) associated with cervical cancer. The study noted that 90 percent of all HPV infections are cleared from the body and do not become chronic. This means that less than one quarter of one percent of all American women are at risk for chronic infection with one of the two HPV types associated with cervical cancer which are contained in Merck's GARDASIL vaccine.
These new HPV prevalence data seriously call into question the cost benefit ratio for GARDASIL, particularly when taking into account short and long term serious vaccine reactions being reported to the Vaccine Adverse Event Reporting System (VAERS), such as five cases of Guillain Barre Syndrome (GBS) and cases of syncope with seizures, facial paralysis and other signs of brain and immune system dysfunction. The Editorial in JAMA also questioned whether the two HPV types in the vaccine would be replaced by the other HPV types associated with cervical cancer, limiting the vaccine's effectiveness. On May 18, 2006, the FDA staff questioned this possibility, as did NVIC in its Feb. 24, 2007 press release ( go to www.nvic.org).
The Washington Times reports that ACIP chairman Jon Abramson and other committee members did not want GARDASIL mandated. If this is true, then ACIP should have stated that fact clearly when they made their recommendation in the summer of 2006 that all 11 year old girls get the vaccine. In light of newly published HPV prevalence data and the fact that Merck only studied GARDASIL in a few hundred eleven year old girls for a few years, together with reports of serious adverse events such as GBS coming into VAERS, the CDC's ACIP members should be more worried about unanimously recommending GARDASIL for routine use with inadequate supporting evidence.
Finally, The New York Times came out with another editorial endorsing the HPV vaccine mandates, despite the growing list of outstanding scientific questions about the vaccine's necessity, safety and effectiveness. The New York Times is behind the times with its knee jerk endorsement of school mandates for this vaccine. Whoever wrote the editorial is particularly cruel to endorse mandates while acknowledging that "it is possible that unexpected side effects could emerge, though any mandate could be suspended if that happened." Is the New York Times editorial staff going to take responsibility for the children who are required to take GARDASIL and suffer serious side effects already reported to VAERS, or the children who will be injured if it is eventually revealed that GARDASIL has more "unexpected side effects?" American children should not be viewed as guinea pigs by drug companies, health officials, doctors, politicians or newspaper editors.
To hear a 30 minute interview explaining the scientific and policy issues relating to proposed HPV vaccine mandates, listen to a tape of the Feb. 22 Brian Lehrer show on WNYC radio entitled "Strange Bedfellows". Describing the show, WNYC says "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."
ABC 20/20 Report Angers Parents
“We need to find out why so many highly vaccinated children are so sick.... .we didn’t [used to] see autistic children. Autism was so rare, most people had never heard of i.... .I don’t think I’ve scared anybody stupid. We do not tell people to vaccinate or not to vaccinate.... . I don’t think you can say good or bad, pro or against.... t’s a complex issue.” - Comments by Barbara Loe Fisher during the ABC Feb. 23, 2007 "20/20" John Stossel special
"My name is Michelle. I am a parent of two young boys and I have been actively researching vaccines for 3 years. I saw that segment on "20/20" regarding vaccines and I was appalled at the slanted spin they put on the vaccine safety issue. The only thing that Barbara Loe Fisher is guilty of is providing parents with the wealth of information regarding vaccine safety that the pharmaceutical companies, the FDA and the CDC conveniently leave out. Therefore, she is simply helping parents to make INFORMED decisions regarding vaccines, not scaring them into not getting vaccinated as John Stossel puts it. The pharmaceutical companies and the government do not want parents to be informed. They want them to remain ignorant and obedient. Therefore, Barbara Loe Fisher, who has saved countless numbers of children from death and injuries related to vaccines, was once again demonized by the pharmaceutical companies and the media and I am absolutely disgusted by this. I just want it to be known that there are infinite numbers of parents just like me who have an undying gratitude and support for Barbara Loe Fisher and the NVIC for their efforts to help parents make a truly informed decision about vaccines." - Email to NVIC on Feb. 24, 2007 at 9:55 a.m., among the many supportive emails and telephone calls NVIC has received since the "20/20" broadcast
"This was a very one sided story. If vaccines are so safe, then why does a portion of the cost of each vaccine ($0.75) given go into the National Vaccine Injury Compensation Program set up by Congress and DHHS? The fund has about $2 billion, and has paid out about $1.5 billion to over 1800 families whose children were injured or killed by a vaccine. The fund was designed to shield vaccine manufacturers from expensive lawsuits. How can a news program do a story about the complex issue of vaccines, and not discuss this, or interview any parent who has had a child harmed or killed by vaccines? Very poor reporting." - Email to ABC "20/20" on Feb. 24 at 9:58 p.m., among the many emails ABC received since the "20/20" broadcast
ABC News Poll (as of 2/26/07) :
Yes, I am worried that some vaccinations could be harmful: 1,236
No, I believe the benefits of vaccination far outweigh any risks: 415
Total: 1,671
Barbara Loe Fisher Commentary:
First, a heartfelt thank you to the many supportive emails and telephone calls mothers and fathers have made to the National Vaccine Information Center since the Feb. 23 ABC "20/20" broadcast from 9 to 11 p.m. EST. and about NVIC to ABC. I understand how upset many parents and grandparents are about the way that NVIC was portrayed and the misinformation about vaccine risks which was communicated during the segment.
Although I am disappointed by the superficial treatment of the subject of vaccine risks and the absence of a discussion about the violation of informed consent rights when it comes to mandatory vaccination laws, not to mention factual errors (the Institute of Medicine clearly DID confirm in 1994 that there is a causal relationship between DPT vaccine and permanent brain dysfunction), ABC at least acknowledged the national debate about vaccine safety. For that, we can thank John Stossel for his hyperactive, short sighted report.
My friends, this sacred cow is not going to be put back into the barn. It is out and running around the farm yard. And for every parent who watched "20/20" and believed that John Stossel and Paul Offit were right, there was a parent who became informed there was a controversy about vaccination and something to think about. Maybe some of them will check out www.NVIC.org and find out NVIC is simply trying to inform people about the risks and complications of diseases and vaccines in order to empower them to be able to speak intelligently with health care professionals and make a better educated vaccination decision for themselves or their children.
The truth about vaccine risks will shine bright and clear at the end of the day, no matter how many try to suppress or distort it. Adversity and challenge can serve to illuminate the truth.
Should Parents Worry About Vaccinating Their Children?
Fears of Vaccinations Rise, Diseases Reemerge
ABC News
February 22, 2007
By JOHN STOSSEL, KRISTINA KENDALL and PATRICK McMENAMIN
Click here for the URL:
Feb. 22, 2007— - When we worry, we worry the most about our children. Everyone wants to keep them safe.
When politicians want us to fall in line, they always talk about saving the children. And our feelings about kids have created very intense emotions about vaccines. Some people say vaccines are dangerous. Robert F. Kennedy Jr. said that they have "poisoned an entire generation of American children."
Kennedy has added his voice to the chorus of angry parents who are convinced that mercury in vaccines causes harm to children.
"It's causing IQ loss, mental retardation, speech delay, language delay, ADD, hyperactivity," he said.
Worrying About Vaccinations
Barbara Loe Fisher, who heads the Vaccine Information Center, goes on television to alert parents about the dangers of vaccines.
On the "Today Show," she said, "We need to find out why so many of our highly vaccinated children are so sick."
The biggest worry today is autism. Before kids received so many vaccines, says Fisher, "you didn't see autistic children. Autism was so rare. Most people had never heard of it."
And the protestors blame the vaccines.
'Vaccines Don't Cause Autism'
Dr. Paul Offit is the chief of infectious diseases at Children's Hospital of Philadelphia. He's also in the vaccine business. He developed and patented the rotavirus vaccine.
"I think that it's perfectly reasonable to be skeptical about anything you put into your body, including vaccines," said Offit. "And vaccines do have side effects. But vaccines don't cause autism."
Offit can say that with confidence because the National Academy of Sciences recently reviewed the science. They concluded that 19 major studies, tracking thousands of kids, all show no link between vaccines and autism.
"The question has been raised, it's been answered," said Offit. "Vaccines don't cause autism."
Then why are so many kids being diagnosed with autism? Because kids we once said had other conditions are now being called autistic.
As researchers from the March of Dimes put it, "improvements in detection and changes in diagnosis account for the observed increase in autism." Their data on autism rates in California showed that the increase in autism diagnoses almost exactly matched a decline in cases of retardation: autism prevalence increased by 9.1 cases per 10,000 children, while mental retardation dropped by 9.3 per 10,000.
"People that we once called quirky or geeky or nerdy are now called autistic," said Offit. "Because when you give that label of say, autistic spectrum disorder, you allow that child then to qualify for services which otherwise they wouldn't be qualified to get."
Not a New Concern
Two decades ago, "20/20" did a report which said that the whooping cough vaccine may lead to permanent neurological disorder and Sudden Infant Death Syndrome (SIDS).
Personal injury lawyer Allen McDowell said vaccine makers were victimizing kids, and more than 20 years later, he still says the vaccine makers put money before safety.
"There's no dispute about that. They were making so much money off the old vaccine they didn't really have any incentive to improve it."
McDowell made money too. The lawyer won lots of lawsuits.
"I made -- a good chunk of money," he said.
The vaccine makers did revise the whooping cough vaccine and the new version was approved by the FDA in 1991.
"The old (whooping cough) vaccine was probably our most reactogenic vaccine, which is to say that it had the highest rate of side effects," says Offit. "I mean, it could cause seizures with fever -- although it didn't cause epilepsy, meaning the permanent seizures --[but] it certainly could trigger seizures..... it caused pain and tenderness at the site of injection..... it caused floppy baby syndrome, a so-called 'hypo-tonic, hypo-response' syndrome. It caused persistent, inconsolable crying. And so, there was always an interest in trying to make that vaccine safer. But the science had to catch up to that."
Those serious side effects were temporary, not the permanent conditions for which lawyers often sued vaccine makers. In fact, comprehensive studies also reviewed by the National Academy of Sciences did not find that the old vaccine caused SIDS or permanent brain damage.
The Benefits of Vaccinations
Lost in this debate is the disease the vaccine prevents. Whooping cough racks a baby's body with violent fits of coughing. In its most extreme form, it kills. But after "20/20'"s vaccine report, many parents told their doctors, "I'm scared of your vaccine."
I asked Dr. Richard Saphir, my children's pediatrician, what he thought of that program.
"It was certainly alarmist," he said.
In fact, when my daughter Lauren got a fever after one of the vaccines, he decided not to give her the final shot, and a short time afterward, she got whooping cough.
Dr. Saphir said that the fact that I was a "20/20" correspondent made him even more anxious about giving my daughter the vaccine.
My daughter recovered from her whooping cough. She was surprised to hear that our reporting could confuse parents and influence doctors.
"Parents go in and force their physicians to agree to not give the vaccines even though the physicians say, you're making a stupid decision?" she asked. "Then you guys are doing a really bad thing."
Parent Suzanne Walther agrees. On internet sites, Walther read so many horror stories about vaccines, that so she postponed vaccinating her daughter, Mary Catherine.
"Some of the vaccine stories said that if I had my child vaccinated they were going to die of SIDS," she said. "I'm very protective of my children, I don't want to do something to them that might cause them harm."
But not vaccinating caused harm. Mary Catherine got very sick with spinal meningitis.
"Our pediatrician put us in an ambulance to go to Vanderbilt Hospital immediately," said Walther. "It is a deadly disease. There's a huge risk of deafness, blindness, it's very painful."
Resurgence of Old Diseases
Mary Catherine recovered, but she's one of many kids who are coming down with diseases doctors once thought were nearly eradicated, like mumps, measles, and whooping cough.
These diseases are coming back because pockets of frightened parents won't vaccinate their kids, some, after they search for information and end up on websites like Barbara Loe Fisher's. I asked Fisher about how sites like hers scare parents.
"You're really the vaccines' scare center. When you scare people stupid, and they don't get vaccinated, that spreads nasty diseases," I said.
"I don't think I've scared anybody stupid. We do not tell people to vaccinate or not vaccinate," she replied.
Fisher says she can't say whether vaccines are "good or bad."
"You can't say vaccines are good, vaccines haven't done more good than harm?" I asked?
"It's a complex issue," she said.
The Fear Factor
McDowell is now thinking about filing new lawsuits saying vaccine companies caused autism. I told him I thought he was an opportunistic hustler, preying on worried parents. McDowell disagreed.
"That's not the way I look at it. I look at it that I'm doing a service for the public in these immunizations."
He said of the whopping cough vaccine that, "if there hadn't been the litigation, they'd still be using the same old vaccine and causing a lot more serious problems."
Nonsense, says Offit. Lawyers didn't make the whooping cough vaccine better. "Science is always a process of evolution, and I think we had to get to the point in science where we could make the kind of purified products at commercial level that, that we couldn't do before," Offit said. The lawsuits "are a great example of just what can happen when, when lawyers go crazy.... I think there's a certain profiteering that comes with, with fear."
So I told McDowell I thought he was part of the Fear Industrial Complex, scaring people and making money off of it. After a long pause, he said, "True."
"My name is Michelle. I am a parent of two young boys and I have been actively researching vaccines for 3 years. I saw that segment on "20/20" regarding vaccines and I was appalled at the slanted spin they put on the vaccine safety issue. The only thing that Barbara Loe Fisher is guilty of is providing parents with the wealth of information regarding vaccine safety that the pharmaceutical companies, the FDA and the CDC conveniently leave out. Therefore, she is simply helping parents to make INFORMED decisions regarding vaccines, not scaring them into not getting vaccinated as John Stossel puts it. The pharmaceutical companies and the government do not want parents to be informed. They want them to remain ignorant and obedient. Therefore, Barbara Loe Fisher, who has saved countless numbers of children from death and injuries related to vaccines, was once again demonized by the pharmaceutical companies and the media and I am absolutely disgusted by this. I just want it to be known that there are infinite numbers of parents just like me who have an undying gratitude and support for Barbara Loe Fisher and the NVIC for their efforts to help parents make a truly informed decision about vaccines." - Email to NVIC on Feb. 24, 2007 at 9:55 a.m., among the many supportive emails and telephone calls NVIC has received since the "20/20" broadcast
"This was a very one sided story. If vaccines are so safe, then why does a portion of the cost of each vaccine ($0.75) given go into the National Vaccine Injury Compensation Program set up by Congress and DHHS? The fund has about $2 billion, and has paid out about $1.5 billion to over 1800 families whose children were injured or killed by a vaccine. The fund was designed to shield vaccine manufacturers from expensive lawsuits. How can a news program do a story about the complex issue of vaccines, and not discuss this, or interview any parent who has had a child harmed or killed by vaccines? Very poor reporting." - Email to ABC "20/20" on Feb. 24 at 9:58 p.m., among the many emails ABC received since the "20/20" broadcast
ABC News Poll (as of 2/26/07) :
Yes, I am worried that some vaccinations could be harmful: 1,236
No, I believe the benefits of vaccination far outweigh any risks: 415
Total: 1,671
Barbara Loe Fisher Commentary:
First, a heartfelt thank you to the many supportive emails and telephone calls mothers and fathers have made to the National Vaccine Information Center since the Feb. 23 ABC "20/20" broadcast from 9 to 11 p.m. EST. and about NVIC to ABC. I understand how upset many parents and grandparents are about the way that NVIC was portrayed and the misinformation about vaccine risks which was communicated during the segment.
Although I am disappointed by the superficial treatment of the subject of vaccine risks and the absence of a discussion about the violation of informed consent rights when it comes to mandatory vaccination laws, not to mention factual errors (the Institute of Medicine clearly DID confirm in 1994 that there is a causal relationship between DPT vaccine and permanent brain dysfunction), ABC at least acknowledged the national debate about vaccine safety. For that, we can thank John Stossel for his hyperactive, short sighted report.
My friends, this sacred cow is not going to be put back into the barn. It is out and running around the farm yard. And for every parent who watched "20/20" and believed that John Stossel and Paul Offit were right, there was a parent who became informed there was a controversy about vaccination and something to think about. Maybe some of them will check out www.NVIC.org and find out NVIC is simply trying to inform people about the risks and complications of diseases and vaccines in order to empower them to be able to speak intelligently with health care professionals and make a better educated vaccination decision for themselves or their children.
The truth about vaccine risks will shine bright and clear at the end of the day, no matter how many try to suppress or distort it. Adversity and challenge can serve to illuminate the truth.
Should Parents Worry About Vaccinating Their Children?
Fears of Vaccinations Rise, Diseases Reemerge
ABC News
February 22, 2007
By JOHN STOSSEL, KRISTINA KENDALL and PATRICK McMENAMIN
Click here for the URL:
Feb. 22, 2007— - When we worry, we worry the most about our children. Everyone wants to keep them safe.
When politicians want us to fall in line, they always talk about saving the children. And our feelings about kids have created very intense emotions about vaccines. Some people say vaccines are dangerous. Robert F. Kennedy Jr. said that they have "poisoned an entire generation of American children."
Kennedy has added his voice to the chorus of angry parents who are convinced that mercury in vaccines causes harm to children.
"It's causing IQ loss, mental retardation, speech delay, language delay, ADD, hyperactivity," he said.
Worrying About Vaccinations
Barbara Loe Fisher, who heads the Vaccine Information Center, goes on television to alert parents about the dangers of vaccines.
On the "Today Show," she said, "We need to find out why so many of our highly vaccinated children are so sick."
The biggest worry today is autism. Before kids received so many vaccines, says Fisher, "you didn't see autistic children. Autism was so rare. Most people had never heard of it."
And the protestors blame the vaccines.
'Vaccines Don't Cause Autism'
Dr. Paul Offit is the chief of infectious diseases at Children's Hospital of Philadelphia. He's also in the vaccine business. He developed and patented the rotavirus vaccine.
"I think that it's perfectly reasonable to be skeptical about anything you put into your body, including vaccines," said Offit. "And vaccines do have side effects. But vaccines don't cause autism."
Offit can say that with confidence because the National Academy of Sciences recently reviewed the science. They concluded that 19 major studies, tracking thousands of kids, all show no link between vaccines and autism.
"The question has been raised, it's been answered," said Offit. "Vaccines don't cause autism."
Then why are so many kids being diagnosed with autism? Because kids we once said had other conditions are now being called autistic.
As researchers from the March of Dimes put it, "improvements in detection and changes in diagnosis account for the observed increase in autism." Their data on autism rates in California showed that the increase in autism diagnoses almost exactly matched a decline in cases of retardation: autism prevalence increased by 9.1 cases per 10,000 children, while mental retardation dropped by 9.3 per 10,000.
"People that we once called quirky or geeky or nerdy are now called autistic," said Offit. "Because when you give that label of say, autistic spectrum disorder, you allow that child then to qualify for services which otherwise they wouldn't be qualified to get."
Not a New Concern
Two decades ago, "20/20" did a report which said that the whooping cough vaccine may lead to permanent neurological disorder and Sudden Infant Death Syndrome (SIDS).
Personal injury lawyer Allen McDowell said vaccine makers were victimizing kids, and more than 20 years later, he still says the vaccine makers put money before safety.
"There's no dispute about that. They were making so much money off the old vaccine they didn't really have any incentive to improve it."
McDowell made money too. The lawyer won lots of lawsuits.
"I made -- a good chunk of money," he said.
The vaccine makers did revise the whooping cough vaccine and the new version was approved by the FDA in 1991.
"The old (whooping cough) vaccine was probably our most reactogenic vaccine, which is to say that it had the highest rate of side effects," says Offit. "I mean, it could cause seizures with fever -- although it didn't cause epilepsy, meaning the permanent seizures --[but] it certainly could trigger seizures..... it caused pain and tenderness at the site of injection..... it caused floppy baby syndrome, a so-called 'hypo-tonic, hypo-response' syndrome. It caused persistent, inconsolable crying. And so, there was always an interest in trying to make that vaccine safer. But the science had to catch up to that."
Those serious side effects were temporary, not the permanent conditions for which lawyers often sued vaccine makers. In fact, comprehensive studies also reviewed by the National Academy of Sciences did not find that the old vaccine caused SIDS or permanent brain damage.
The Benefits of Vaccinations
Lost in this debate is the disease the vaccine prevents. Whooping cough racks a baby's body with violent fits of coughing. In its most extreme form, it kills. But after "20/20'"s vaccine report, many parents told their doctors, "I'm scared of your vaccine."
I asked Dr. Richard Saphir, my children's pediatrician, what he thought of that program.
"It was certainly alarmist," he said.
In fact, when my daughter Lauren got a fever after one of the vaccines, he decided not to give her the final shot, and a short time afterward, she got whooping cough.
Dr. Saphir said that the fact that I was a "20/20" correspondent made him even more anxious about giving my daughter the vaccine.
My daughter recovered from her whooping cough. She was surprised to hear that our reporting could confuse parents and influence doctors.
"Parents go in and force their physicians to agree to not give the vaccines even though the physicians say, you're making a stupid decision?" she asked. "Then you guys are doing a really bad thing."
Parent Suzanne Walther agrees. On internet sites, Walther read so many horror stories about vaccines, that so she postponed vaccinating her daughter, Mary Catherine.
"Some of the vaccine stories said that if I had my child vaccinated they were going to die of SIDS," she said. "I'm very protective of my children, I don't want to do something to them that might cause them harm."
But not vaccinating caused harm. Mary Catherine got very sick with spinal meningitis.
"Our pediatrician put us in an ambulance to go to Vanderbilt Hospital immediately," said Walther. "It is a deadly disease. There's a huge risk of deafness, blindness, it's very painful."
Resurgence of Old Diseases
Mary Catherine recovered, but she's one of many kids who are coming down with diseases doctors once thought were nearly eradicated, like mumps, measles, and whooping cough.
These diseases are coming back because pockets of frightened parents won't vaccinate their kids, some, after they search for information and end up on websites like Barbara Loe Fisher's. I asked Fisher about how sites like hers scare parents.
"You're really the vaccines' scare center. When you scare people stupid, and they don't get vaccinated, that spreads nasty diseases," I said.
"I don't think I've scared anybody stupid. We do not tell people to vaccinate or not vaccinate," she replied.
Fisher says she can't say whether vaccines are "good or bad."
"You can't say vaccines are good, vaccines haven't done more good than harm?" I asked?
"It's a complex issue," she said.
The Fear Factor
McDowell is now thinking about filing new lawsuits saying vaccine companies caused autism. I told him I thought he was an opportunistic hustler, preying on worried parents. McDowell disagreed.
"That's not the way I look at it. I look at it that I'm doing a service for the public in these immunizations."
He said of the whopping cough vaccine that, "if there hadn't been the litigation, they'd still be using the same old vaccine and causing a lot more serious problems."
Nonsense, says Offit. Lawyers didn't make the whooping cough vaccine better. "Science is always a process of evolution, and I think we had to get to the point in science where we could make the kind of purified products at commercial level that, that we couldn't do before," Offit said. The lawsuits "are a great example of just what can happen when, when lawyers go crazy.... I think there's a certain profiteering that comes with, with fear."
So I told McDowell I thought he was part of the Fear Industrial Complex, scaring people and making money off of it. After a long pause, he said, "True."
20/20
"I think parents are wondering why every time industry produces a vaccine it is automatically added to the mandatory list of vaccines for school entry." - Barbara Loe Fisher, ABC's Good Morning America, February 23, 2007
"Gov. Rick Perry's chief of staff met with key aides about a new vaccine to prevent cervical cancer on the same day its manufacturer donated money to his campaign, documents obtained by The Associated Press show. Texas became the first state to require the vaccine against human papillomavirus earlier this month when Perry issued an executive order requiring it for girls entering sixth grade. Lawmakers are considering overriding the measure. A calendar for chief of staff Deirdre Delisi obtained under Texas' open records laws shows she met with the governor's budget director and three members of his office for an "HPV Vaccine for Children Briefing" on Oct. 16. That same day, Merck & Co. (MRK)'s political action committee donated $5,000 to Perry and a total of $5,000 to eight state lawmakers. Perry spokesman Robert Black said the timing of the meeting and the donation was a coincidence. "There was no discussion of any kind of mandates," Black said." - Liz Austin Peterson, Associated Press , February 21, 2007, Vaccine Meeting, Merck Donation Coincide
"Health officials have been cautiously watching for reports of Guillain-Barre syndrome, a paralyzing side effect that has been associated with a few other vaccines. In the reporting period, there were three such cases. "Based on these numbers, it's not worrisome to us that there's any sort of association between the vaccine" and Guillain-Barre, Iskander said. Today, a Virginia-based advocacy group, the National Vaccine Information Center, which focuses on the risks of immunizations, put out a press release warning of Gardasil side effects. The group said health officials did not do enough research into whether the vaccine leads to harmful problems when combined with other shots. But Iskander said there's no evidence Gardasil is harmful in combination with other vaccines. The advocacy group also questioned a movement by some state legislatures to order the vaccine be given to all girls. "We just don't know enough to be mandating Gardasil for anyone, much less vulnerable 11- to 12-year-old girls entering puberty," said Barbara Loe Fisher, the organization's president, in a prepared statement. On Tuesday, Merck announced it was dropping its lobbying campaign to persuade states to make the cancer vaccine required for adolescent girls attending public school." - Mike Stobbe, Associated Press , February 21, 2007,
HPV Vaccine Won't Get New Warnings, Officials Say
Barbara Loe Fisher Commentary:
This morning, ABC's "Good Morning America" aired a 7:15 a.m. segment on the controversy about the proposed HPV vaccine mandates, on which I appeared to state "I think parents are wondering why every time industry produces a vaccine it is automatically added to the mandatory list for school entry." Tonight from 9 to 11 p.m. EST the network will broadcast a special two-hour show featuring libertarian John Stossel and his view of how people perceive risks and whether the actions they take to minimize their perceived risks can have unintended consequences. I was interviewed for this show and, today, was informed by A-CHAMP in their Action Alert that the show is entitled "Scared Stiff: Worried in America" and that promotional copy for the show states "Stossel looks at the debate and concludes that activists and lawyers may be killing people by frightening the public about vaccines." In its Action Alert, A-CHAMP said that parents had already contacted ABC to register disapproval of "one-sided and inflammatory programming and promotion." I hope that the segment of this show about vaccine safety concerns of the public is not as one-sided and inflammatory as the promotional rhetoric suggests. If it is, then most likely the goal of the show was to shut down the vaccine safety and informed consent debate that has been taking place in the living rooms of families across America for the past two decades and has begun to be addressed in the public arena during the past two months. There is nothing that anyone can say or do on television or radio or in the pages of medical journals or newspapers which will erase the experience of hundreds of thousands of parents in America, who have witnessed their once healthy children regress physically, mentally and emotionally after receiving one or more government mandated vaccines. The truth about vaccine risks and the perception of those risks belongs to those who take the risk and are left to deal with the consequences: mothers and fathers in America and around the world. Children who are injured or die from vaccination are equally as important as children who are injured or die from infectious diseases. The hallmark of a humane society is to care about all human life and not consider some expendable in service to the rest. The National Vaccine Information Center is proud to stand for the right of citizens to have access to all information about the risks and complications of diseases and the risks and complications of vaccines and the right to make an informed, voluntary decision about which risk to take.
"Gov. Rick Perry's chief of staff met with key aides about a new vaccine to prevent cervical cancer on the same day its manufacturer donated money to his campaign, documents obtained by The Associated Press show. Texas became the first state to require the vaccine against human papillomavirus earlier this month when Perry issued an executive order requiring it for girls entering sixth grade. Lawmakers are considering overriding the measure. A calendar for chief of staff Deirdre Delisi obtained under Texas' open records laws shows she met with the governor's budget director and three members of his office for an "HPV Vaccine for Children Briefing" on Oct. 16. That same day, Merck & Co. (MRK)'s political action committee donated $5,000 to Perry and a total of $5,000 to eight state lawmakers. Perry spokesman Robert Black said the timing of the meeting and the donation was a coincidence. "There was no discussion of any kind of mandates," Black said." - Liz Austin Peterson, Associated Press , February 21, 2007, Vaccine Meeting, Merck Donation Coincide
"Health officials have been cautiously watching for reports of Guillain-Barre syndrome, a paralyzing side effect that has been associated with a few other vaccines. In the reporting period, there were three such cases. "Based on these numbers, it's not worrisome to us that there's any sort of association between the vaccine" and Guillain-Barre, Iskander said. Today, a Virginia-based advocacy group, the National Vaccine Information Center, which focuses on the risks of immunizations, put out a press release warning of Gardasil side effects. The group said health officials did not do enough research into whether the vaccine leads to harmful problems when combined with other shots. But Iskander said there's no evidence Gardasil is harmful in combination with other vaccines. The advocacy group also questioned a movement by some state legislatures to order the vaccine be given to all girls. "We just don't know enough to be mandating Gardasil for anyone, much less vulnerable 11- to 12-year-old girls entering puberty," said Barbara Loe Fisher, the organization's president, in a prepared statement. On Tuesday, Merck announced it was dropping its lobbying campaign to persuade states to make the cancer vaccine required for adolescent girls attending public school." - Mike Stobbe, Associated Press , February 21, 2007,
HPV Vaccine Won't Get New Warnings, Officials Say
Barbara Loe Fisher Commentary:
This morning, ABC's "Good Morning America" aired a 7:15 a.m. segment on the controversy about the proposed HPV vaccine mandates, on which I appeared to state "I think parents are wondering why every time industry produces a vaccine it is automatically added to the mandatory list for school entry." Tonight from 9 to 11 p.m. EST the network will broadcast a special two-hour show featuring libertarian John Stossel and his view of how people perceive risks and whether the actions they take to minimize their perceived risks can have unintended consequences. I was interviewed for this show and, today, was informed by A-CHAMP in their Action Alert that the show is entitled "Scared Stiff: Worried in America" and that promotional copy for the show states "Stossel looks at the debate and concludes that activists and lawyers may be killing people by frightening the public about vaccines." In its Action Alert, A-CHAMP said that parents had already contacted ABC to register disapproval of "one-sided and inflammatory programming and promotion." I hope that the segment of this show about vaccine safety concerns of the public is not as one-sided and inflammatory as the promotional rhetoric suggests. If it is, then most likely the goal of the show was to shut down the vaccine safety and informed consent debate that has been taking place in the living rooms of families across America for the past two decades and has begun to be addressed in the public arena during the past two months. There is nothing that anyone can say or do on television or radio or in the pages of medical journals or newspapers which will erase the experience of hundreds of thousands of parents in America, who have witnessed their once healthy children regress physically, mentally and emotionally after receiving one or more government mandated vaccines. The truth about vaccine risks and the perception of those risks belongs to those who take the risk and are left to deal with the consequences: mothers and fathers in America and around the world. Children who are injured or die from vaccination are equally as important as children who are injured or die from infectious diseases. The hallmark of a humane society is to care about all human life and not consider some expendable in service to the rest. The National Vaccine Information Center is proud to stand for the right of citizens to have access to all information about the risks and complications of diseases and the risks and complications of vaccines and the right to make an informed, voluntary decision about which risk to take.
NVIC Releases GARDASIL Report - Merck Stops Mandate Push
"Merck & Co. will stop lobbying state officials to require that girls receive the company's Gardasil cervical cancer vaccine before they can attend school. Merck made the decision after groups including the American Academy of Pediatrics said there wasn't enough state funding to pay for the $360 vaccine or public acceptance, said Rick Haupt, director of medical affairs for Merck's vaccine division, in a telephone interview today....The vaccine is Merck's most important new product, capable of generating as much as $3 billion in annual sales, analysts have said. Revenue from Gardasil in the fourth quarter reached $155 million.... Starting in 2008, Texas girls ages 11 and 12 will be required to have the vaccine before entering sixth grade. The shots will cost the state $50 million the first year....A group called the National Vaccine Information Center said yesterday that its analysis of reports to U.S. regulators found cases of serious side effects to Gardasil. One was Guillain-Barre Syndrome, a disorder in which the body's immune system attacks part of the nervous system." - Shannon Pettypiece and Angela Zimm, Bloomberg News , February 20, 2007, Merck Stops Campaign to Mandate Gardasil Vaccine Use
"Merck & Co., bowing to pressure from parents and medical groups, is immediately suspending its lobbying campaign to persuade state legislatures to mandate that adolescent girls get the company's new vaccine against cervical cancer as a requirement for school attendance....Legislatures in roughly 20 states have introduced measures that would mandate girls have the vaccine to attend school, but none has passed so far. However, Texas Gov. Rick Perry on Feb. 2 issued an executive order requiring that schoolgirls get the vaccinations, triggering protests from lawmakers in that state, who may seek to pass a law of overturning the order. A group of parents worried that vaccines harm some children, the National Vaccine Information Center, has been publicizing reports of side effects - mostly dizziness and fainting - in several dozen people getting Gardasil, which is approved for use in females ages 9 to 26. The group questions whether it was tested in enough young girls. Officials with the Centers for Disease Control and Prevention, however, say that reports of side effects through the end of January show don't raise any red flags." - Linda Johnson, Associated Press February 20, 2007, Merck Suspends Lobbying for Cervical Cancer Vaccine Mandate
Barbara Loe Fisher Commentary:
About 12 hours after PROVE president Dawn Richardson and scores of parents and doctors testified in the Texas state legislature, protesting the HPV vaccine mandate being imposed on 11 year old girls in that state by the Governor of Texas, Merck announced it was ending its aggressive lobbying campaign to get GARDASIL mandated in every state. Dawn used advance information provided to her by NVIC from the Report on VAERS and GARDASIL that NVIC released today (below) in her testimony, arguing that the vaccine had not been tested adequately for safety in little girls and was already causing too many reactions. The Texas legislature is in the process of building a bi-partisan coalition to pass legislation that will overturn Governor Rick Perry's Executive order mandating the vaccine for all sixth grade girls.
The backlash in Texas is also being felt in other states, as parents are letting legislators know they are tired of having every vaccine, which industry produces and the CDC recommends for universal use in all children, automatically mandated by the states for school entry. From now on, perhaps citizens and their elected officials will work together to more carefully evaluate the necessity for and safety and efficacy of new vaccines which those, who are operating and profiting from the mass vaccination system, lobby to have mandated.
With 56 doses of 16 vaccines recommended by the CDC for use by all children by age 12 and more than 3 dozen of those already mandated in most states, a careful examination of each new vaccine that industry markets is long overdue. The fact that many highly vaccinated children are suffering with chronic disease and disability, with 1 in 150 autistic, 1 in 6 learning delayed and millions more asthmatic and diabetic, makes it even more important for the FDA and CDC to redouble their efforts to hold vaccine manufacturers to high standards for proof of safety for vaccines before they are licensed and recommended for universal use by all children.
After 25 years, the vaccine safety and informed consent movement led by parents of vaccine injured children has become a national voice for those who want truth, transparency and freedom of choice when it comes to making vaccination decisions for themselves and their children. Today, many more Americans are joining with NVIC and declaring: No forced vaccination. Not in America.
VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORT
Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS
(Feb. 21) Washington, D.C. – The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck’s GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.
“Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur,” said NVIC President Barbara Loe Fisher. “There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria- acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine.”
According to NVIC’s report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome. Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck’s Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13.
“About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine,” said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. “Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence- based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor’s office after they get vaccinated.”
NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown “strong conversion to all 4 vaccine types” but “tested positive for high risk HPV” in 2006, according to the VAERS report.
In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be “the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination.” Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.
The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine.
VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems.
“If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported,” said Fisher. “How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don’t know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty.”
For a copy of NVIC’s Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.
"Merck & Co., bowing to pressure from parents and medical groups, is immediately suspending its lobbying campaign to persuade state legislatures to mandate that adolescent girls get the company's new vaccine against cervical cancer as a requirement for school attendance....Legislatures in roughly 20 states have introduced measures that would mandate girls have the vaccine to attend school, but none has passed so far. However, Texas Gov. Rick Perry on Feb. 2 issued an executive order requiring that schoolgirls get the vaccinations, triggering protests from lawmakers in that state, who may seek to pass a law of overturning the order. A group of parents worried that vaccines harm some children, the National Vaccine Information Center, has been publicizing reports of side effects - mostly dizziness and fainting - in several dozen people getting Gardasil, which is approved for use in females ages 9 to 26. The group questions whether it was tested in enough young girls. Officials with the Centers for Disease Control and Prevention, however, say that reports of side effects through the end of January show don't raise any red flags." - Linda Johnson, Associated Press February 20, 2007, Merck Suspends Lobbying for Cervical Cancer Vaccine Mandate
Barbara Loe Fisher Commentary:
About 12 hours after PROVE president Dawn Richardson and scores of parents and doctors testified in the Texas state legislature, protesting the HPV vaccine mandate being imposed on 11 year old girls in that state by the Governor of Texas, Merck announced it was ending its aggressive lobbying campaign to get GARDASIL mandated in every state. Dawn used advance information provided to her by NVIC from the Report on VAERS and GARDASIL that NVIC released today (below) in her testimony, arguing that the vaccine had not been tested adequately for safety in little girls and was already causing too many reactions. The Texas legislature is in the process of building a bi-partisan coalition to pass legislation that will overturn Governor Rick Perry's Executive order mandating the vaccine for all sixth grade girls.
The backlash in Texas is also being felt in other states, as parents are letting legislators know they are tired of having every vaccine, which industry produces and the CDC recommends for universal use in all children, automatically mandated by the states for school entry. From now on, perhaps citizens and their elected officials will work together to more carefully evaluate the necessity for and safety and efficacy of new vaccines which those, who are operating and profiting from the mass vaccination system, lobby to have mandated.
With 56 doses of 16 vaccines recommended by the CDC for use by all children by age 12 and more than 3 dozen of those already mandated in most states, a careful examination of each new vaccine that industry markets is long overdue. The fact that many highly vaccinated children are suffering with chronic disease and disability, with 1 in 150 autistic, 1 in 6 learning delayed and millions more asthmatic and diabetic, makes it even more important for the FDA and CDC to redouble their efforts to hold vaccine manufacturers to high standards for proof of safety for vaccines before they are licensed and recommended for universal use by all children.
After 25 years, the vaccine safety and informed consent movement led by parents of vaccine injured children has become a national voice for those who want truth, transparency and freedom of choice when it comes to making vaccination decisions for themselves and their children. Today, many more Americans are joining with NVIC and declaring: No forced vaccination. Not in America.
VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORT
Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS
(Feb. 21) Washington, D.C. – The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck’s GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.
“Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur,” said NVIC President Barbara Loe Fisher. “There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria- acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine.”
According to NVIC’s report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome. Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck’s Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13.
“About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine,” said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. “Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence- based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor’s office after they get vaccinated.”
NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown “strong conversion to all 4 vaccine types” but “tested positive for high risk HPV” in 2006, according to the VAERS report.
In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be “the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination.” Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.
The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine.
VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems.
“If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported,” said Fisher. “How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don’t know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty.”
For a copy of NVIC’s Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.
NVIC on "Today Show, Rotavirus Vaccine Warning Has Been Sent
"This is about requiring 11-year old girls to get a vaccine that has not been proven safe for girls entering puberty. Merck only studied the vaccine in a few hundred 11 year old girls and followed them up for less than two years. And before we add one more vaccine to the more than 40 doses of vaccines we ask our kids to get before they can attend school, we need to find out why so many of our highly vaccinated children are sick - one in 150 autistic, 1 in 6 learning delayed...We cannot be conducting a vaccine experiment on our little girls. This is not the way to cure cervical cancer. We have to do better science." - Barbara Loe Fisher, NVIC President, "Today Show", February 13, 2007
Click Here to View the Today Show segment on HPV Vaccine
"The FDA's public health notification about the intussusception cases includes these recommendations: "Parents should contact their child's doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception. It is important to contact the child's doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose." The FDA also asks that any cases of intussusception be reported to the Vaccine Adverse Event Reporting System (VAERS), which is run by the FDA and CDC." - Miranda Hitti, WebMd Medical News
Barbara Loe Fisher Commentary:
Yesterday, (2/13/07) I appeared on NBC's "The Today Show," where I debated NBC resident doctor Nancy Snyderman, M.D. and Texas legislator Jessica Farrar, who introduced a bill in Texas to require sixth grade girls to get HPV vaccine. This debate was a follow-up to the Feb. 5 debate between Rep. Farrar and PROVE president Dawn Richardson, which generated so much email and letters to NBC that they decided to follow-up. This was my fourth debate with physicians on the "Today Show" in the past 15 years, the last one being a decade ago with Johns Hopkin's Neal Halsey, M.D.
NBC was the network which broke the story, in 1982, about vaccine risks. Lea Thompson, a mother and consumer reporter for the NBC affiliate in Washington, D.C., produced an Emmy award winning documentary "DPT: Vaccine Roulette." That show served as the foundation for the vaccine safety and informed consent movement, which parents launched with the founding of a parent-led organization now known as the National Vaccine Information Center. The medical literature NBC reporter Thompson used to document DPT vaccine risks served as my foundation for co-authoring the book DPT: A Shot in the Dark published by Harcourt Brace Jovanovich in 1985. NBC deserves credit for allowing live debates to take place about vaccine safety over the years so the public can be better informed about the subject of vaccination.
After the "Today Show" ended yesterday and before I flew back to Washington, D.C., I ran into Merck's Rotateq vaccine co-patent holder, Paul Offit, M.D. in the lobby of another studio. I wonder if he knew that, by the end of the day, the FDA would issue a warning to parents to be on the lookout for their babies bowels collapsing after getting injected with the diarrhea vaccine he and other interested parties persuaded the CDC to recommend for use by all babies.
The FDA is asking doctors and parents to report cases of bowel blockage (intussusception) that babies suffer after getting Rotateq to the federal Vaccine Adverse Event Reporting System(VAERS). The FDA should also be asking doctors and parents to report all serious health problems after little girls get injected with Merck's HPV Vaccine, GARDASIL.
Serious Bowel Problems Reported in 28 U.S. Babies After Getting RotaTeq Vaccine
WebMD Medical News
Published: February 13, 2007
by Miranda Hitti
Feb. 13, 2007 -- The FDA today announced that 28 U.S. babies reportedly developed a potentially deadly bowel problem after getting the RotaTeq vaccine. The babies developed intussusception, a serious and potentially life-threatening condition in which the intestine gets blocked or twisted.
Sixteen of the 28 babies required hospitalization and surgery. The other 12 needed enemas to reduce the intussusception. None died.
RotaTeq targets rotavirus, a leading cause of kids' diarrhea. The vaccine, approved by the FDA last year, is on the CDC's 2007 recommended child immunization schedule. It's given in three doses when babies are 2 to 6 months old.
It's not known whether RotaTeq caused the babies' intussusception. The number of reported cases is in line with expectations, says the FDA.
However, a different rotavirus vaccine, called RotaShield, was withdrawn from the market in 1999 after a rise in intussusception was noted after its use.
RotaTeq's label has been updated to reflect the intusssusception reports. But the vaccine's "dosage and administration schedule remains unchanged," says the FDA.
The FDA's Recommendations
The FDA's public health notification about the intussusception cases includes these recommendations:
"Parents should contact their child's doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception. It is important to contact the child's doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose."
The FDA also asks that any cases of intussusception be reported to the Vaccine Adverse Event Reporting System (VAERS), which is run by the FDA and CDC.
For a copy of the vaccine reporting form, call 800- 822-7967 or go online to www.vaers.hhs.gov.
Reported Cases
The 28 cases of intussusception were reported between the FDA's approval of RotaTeq on Feb. 3, 2006 and Jan. 31, 2007.
RotaTeq's intussusception risk was studied in approximately 70,000 infants -- half of whom got the RotaTeq vaccine; the other half got a placebo -- before the FDA approved RotaTeq.
Those studies showed "no significant increased risk of intussusception," notes an FDA public health notice.
The FDA also says that "the number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected," based on unpublished CDC data.
According to the FDA, about 3.5 million doses of RotaTeq had been distributed in the U.S. through Feb. 1, 2007, but not all of those doses have been administered.
The 28 intussusception cases were reported after the first, second, and third doses of the vaccine. The cases occurred within 73 days after getting any of those doses; roughly half of the cases happened within 21 days.
The FDA's Past Comments
When the FDA approved RotaTeq just over a year ago, the FDA's Jesse Goodman, MD, MPH, called data from the vaccine's preapproval studies "reassuring."
But Goodman, who directs the FDA's Center for Biologics Evaluation and Research, also said at the time that "people would need to consider that [the studies] are not conclusive that this side effect could not potentially occur" and that the FDA had put in place "an extremely aggressive program to try to get as much information about the vaccine in its early period of use as possible."
Further studies are being done to probe the risk of intussusception and other serious events with RotaTeq.
RotaTeq's maker, the drug company Merck, is conducting a postmarketing study of approximately 44,000 infants. The CDC is doing its own study of about 90,000 infants, says the FDA. Merck is a WebMD sponsor.
Merck's Comments
WebMD contacted Merck for the company's comments.
In a news release emailed to WebMD, Merck states that intussusception is "a naturally occurring event in infants" that is estimated to occur in approximately one in 2,000 infants during the first year of life.
"Cases of intussusception can occur when no vaccine has been given, and the cause is usually unknown," Merck states.
The news release also includes comments from Mark Feinberg, MD, PhD, vice president of policy, public health, and medical affairs for Merck Vaccines.
"It is common for post-marketing experience information with a vaccine to be reported to VAERS and for the prescribing information to be updated accordingly," Feinberg says, in the news release.
Feinberg says public health and patient safety are Merck's "highest priorities" and that Merck is "very confident" in the data supporting RotaTeq's safety profile from its preapproval study.
RotaShield, the vaccine that was withdrawn from the market in 1999, was made by the drug company Wyeth.
Wyeth is a WebMD sponsor.
Click Here to View the Today Show segment on HPV Vaccine
"The FDA's public health notification about the intussusception cases includes these recommendations: "Parents should contact their child's doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception. It is important to contact the child's doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose." The FDA also asks that any cases of intussusception be reported to the Vaccine Adverse Event Reporting System (VAERS), which is run by the FDA and CDC." - Miranda Hitti, WebMd Medical News
Barbara Loe Fisher Commentary:
Yesterday, (2/13/07) I appeared on NBC's "The Today Show," where I debated NBC resident doctor Nancy Snyderman, M.D. and Texas legislator Jessica Farrar, who introduced a bill in Texas to require sixth grade girls to get HPV vaccine. This debate was a follow-up to the Feb. 5 debate between Rep. Farrar and PROVE president Dawn Richardson, which generated so much email and letters to NBC that they decided to follow-up. This was my fourth debate with physicians on the "Today Show" in the past 15 years, the last one being a decade ago with Johns Hopkin's Neal Halsey, M.D.
NBC was the network which broke the story, in 1982, about vaccine risks. Lea Thompson, a mother and consumer reporter for the NBC affiliate in Washington, D.C., produced an Emmy award winning documentary "DPT: Vaccine Roulette." That show served as the foundation for the vaccine safety and informed consent movement, which parents launched with the founding of a parent-led organization now known as the National Vaccine Information Center. The medical literature NBC reporter Thompson used to document DPT vaccine risks served as my foundation for co-authoring the book DPT: A Shot in the Dark published by Harcourt Brace Jovanovich in 1985. NBC deserves credit for allowing live debates to take place about vaccine safety over the years so the public can be better informed about the subject of vaccination.
After the "Today Show" ended yesterday and before I flew back to Washington, D.C., I ran into Merck's Rotateq vaccine co-patent holder, Paul Offit, M.D. in the lobby of another studio. I wonder if he knew that, by the end of the day, the FDA would issue a warning to parents to be on the lookout for their babies bowels collapsing after getting injected with the diarrhea vaccine he and other interested parties persuaded the CDC to recommend for use by all babies.
The FDA is asking doctors and parents to report cases of bowel blockage (intussusception) that babies suffer after getting Rotateq to the federal Vaccine Adverse Event Reporting System(VAERS). The FDA should also be asking doctors and parents to report all serious health problems after little girls get injected with Merck's HPV Vaccine, GARDASIL.
Serious Bowel Problems Reported in 28 U.S. Babies After Getting RotaTeq Vaccine
WebMD Medical News
Published: February 13, 2007
by Miranda Hitti
Feb. 13, 2007 -- The FDA today announced that 28 U.S. babies reportedly developed a potentially deadly bowel problem after getting the RotaTeq vaccine. The babies developed intussusception, a serious and potentially life-threatening condition in which the intestine gets blocked or twisted.
Sixteen of the 28 babies required hospitalization and surgery. The other 12 needed enemas to reduce the intussusception. None died.
RotaTeq targets rotavirus, a leading cause of kids' diarrhea. The vaccine, approved by the FDA last year, is on the CDC's 2007 recommended child immunization schedule. It's given in three doses when babies are 2 to 6 months old.
It's not known whether RotaTeq caused the babies' intussusception. The number of reported cases is in line with expectations, says the FDA.
However, a different rotavirus vaccine, called RotaShield, was withdrawn from the market in 1999 after a rise in intussusception was noted after its use.
RotaTeq's label has been updated to reflect the intusssusception reports. But the vaccine's "dosage and administration schedule remains unchanged," says the FDA.
The FDA's Recommendations
The FDA's public health notification about the intussusception cases includes these recommendations:
"Parents should contact their child's doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception. It is important to contact the child's doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose."
The FDA also asks that any cases of intussusception be reported to the Vaccine Adverse Event Reporting System (VAERS), which is run by the FDA and CDC.
For a copy of the vaccine reporting form, call 800- 822-7967 or go online to www.vaers.hhs.gov.
Reported Cases
The 28 cases of intussusception were reported between the FDA's approval of RotaTeq on Feb. 3, 2006 and Jan. 31, 2007.
RotaTeq's intussusception risk was studied in approximately 70,000 infants -- half of whom got the RotaTeq vaccine; the other half got a placebo -- before the FDA approved RotaTeq.
Those studies showed "no significant increased risk of intussusception," notes an FDA public health notice.
The FDA also says that "the number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected," based on unpublished CDC data.
According to the FDA, about 3.5 million doses of RotaTeq had been distributed in the U.S. through Feb. 1, 2007, but not all of those doses have been administered.
The 28 intussusception cases were reported after the first, second, and third doses of the vaccine. The cases occurred within 73 days after getting any of those doses; roughly half of the cases happened within 21 days.
The FDA's Past Comments
When the FDA approved RotaTeq just over a year ago, the FDA's Jesse Goodman, MD, MPH, called data from the vaccine's preapproval studies "reassuring."
But Goodman, who directs the FDA's Center for Biologics Evaluation and Research, also said at the time that "people would need to consider that [the studies] are not conclusive that this side effect could not potentially occur" and that the FDA had put in place "an extremely aggressive program to try to get as much information about the vaccine in its early period of use as possible."
Further studies are being done to probe the risk of intussusception and other serious events with RotaTeq.
RotaTeq's maker, the drug company Merck, is conducting a postmarketing study of approximately 44,000 infants. The CDC is doing its own study of about 90,000 infants, says the FDA. Merck is a WebMD sponsor.
Merck's Comments
WebMD contacted Merck for the company's comments.
In a news release emailed to WebMD, Merck states that intussusception is "a naturally occurring event in infants" that is estimated to occur in approximately one in 2,000 infants during the first year of life.
"Cases of intussusception can occur when no vaccine has been given, and the cause is usually unknown," Merck states.
The news release also includes comments from Mark Feinberg, MD, PhD, vice president of policy, public health, and medical affairs for Merck Vaccines.
"It is common for post-marketing experience information with a vaccine to be reported to VAERS and for the prescribing information to be updated accordingly," Feinberg says, in the news release.
Feinberg says public health and patient safety are Merck's "highest priorities" and that Merck is "very confident" in the data supporting RotaTeq's safety profile from its preapproval study.
RotaShield, the vaccine that was withdrawn from the market in 1999, was made by the drug company Wyeth.
Wyeth is a WebMD sponsor.
HPV Vaccine Hotly Debated on Today Show
"There is no medical emergency in the state of Texas over cervical cancer. The emergency is in the board room of Merck because they've seen this [HPV vaccine mandate] measure fail in three states and they want to make sure this thing doesn't go down the tubes.......The product was only tested in 1200 little girls under the age of 16. That is not nearly enough information to base a policy that is going to affect hundreds of thousands of girls in the United States, perhaps possibly even millions...This is a very, very expensive vaccine. The amount of money it is going to take to vaccinate every single little girls at the age of 11 and do that every year - we don't know because the vaccine hasn't been followed up long enough to know that this is actually going to have an impact when these little girls are old enough to develop cervical cancer...." - Dawn Richardson, The Today Show, Feb. 5, 2007
"Legislation mandating the HPV vaccine for pre-adolescent schoolgirls is pending in the District, Maryland and Virginia. Those who advocate it are quick to note that parents can opt out of the program. But few can say exactly how many bureaucratic hoops a parent will have to jump through to do that. Besides, why should the onus be on the parents to figure out how not to be in a government-mandated program? In New Hampshire, parents opt in -- and the burden is on the government to show how the vaccine can benefit their children....So are New Hampshire residents somehow smarter and better able to develop effective public health programs? Are they more concerned about their children than the rest of us? Hardly. What they have that we do not is the right attitude. They take their state motto seriously: "Live Free or Die," while too many of us are content to live and die as slaves." - Courtland Milloy, Washington Post , January 24, 2007, Force Is Not the Only Way to Administer a Vaccine
Barbara Loe Fisher Commentary:
This morning (Feb. 5) on the NBC "Today Show," (see the video HPV Vaccine is mandatory in Texas) Dawn Richardson, the President of PROVE (Parents Requesting Open Vaccine Education) in Texas debated Texas Rep. Jessica Farrar (D) who supports the Executive Order issued by the Republican Governor of Texas, Rick Perry, on Feb. 2 mandating that all sixth grade girls gets three doses of HPV vaccine in order to attend school. Dawn made the point that "the Governor has side stepped policy...there is no way for the people of this state to be able to add input and for the legislature to be able to debate and decide and this is just plain wrong."
Although Dawn was supposed to be only debating the legislator, she ended up also debating NBC doc Nancy Snyderman, who offered her opinion on the intelligence of state legislators when she qualified that she was speaking "as an American citizen" and proclaimed "I never feel better when legislators start arguing about the science. They haven't done a good job with stem cells and they haven't done a good job with basic science and I am not so sure they are going to do a better job with this...."
And therein lies the problem with medical doctors at Merck and medical doctors in state health departments and medical doctors at the CDC and many medical doctors in the U.S. occupying a position of authority (like on TV) : they just can't help telling other people what to do. And they get really, really mad if you don't do what they tell you to do - for your own good and everyone's else's good, of course. Their favorite tactic, when they really don't want you to understand the risks you are about to take with whatever they are telling you to do, is: "You don't understand. You couldn't possibly understand the complexities of this issue. I'll make the decision for you."
Well, Nancy, I've got news for you. The majority of us ordinary non-M.D. Americans believe in our right to fully participate in the creation of the laws which govern us by working through our elected officials, in this case, our state legislators. We don't believe in a medical aristocracy running the show. We actually believe our elected officials, like us, have a brain and can think through these tough issues like whether our pre-adolescent daughters ought to be injected with a vaccine that Merck only tested in a few thousand little girls or whether we should be paying higher health insurance premiums to spend $4 billion to prevent 3700 cervical cancer deaths in the U.S. that could be avoided if women just got pap smears and early treatment of pre-cancerous lesions. We don't think these issues have nearly as much to do about sex (that convenient red herring) as it does about this HPV vaccine's safety, necessity and cost.
The days when Moms (and legislators) bow down to medical doctors and drug companies and offer up their children to every new vaccine that comes down the pike are over. Faith without question rightly belongs in Cathedrals and Temples, but not in the halls of our state Capitols or Congress.
Parents all over America are standing up and shouting now: Show us the Science and Give us a Choice.
Just in time.
LETTERS TO THE EDITOR (Published)
The Washington Post
February 1, 2007
Thanks to columnist Courtland Milloy for his courageous defense of the informed consent ethic, which includes allowing parents to make informed, voluntary vaccination decisions for their children ["Force Is Not the Only Way to Administer a Vaccine," Metro section, Jan. 24]. Mr. Milloy makes the point that if the governed are to respect and have confidence in those who govern them, state officials must treat citizens with respect, rather than using coercion and intimidation to implement health policies.
In addition to the human papillomavirus vaccine, many vaccines are being developed for diseases that depart from the smallpox and polio model and are not transmissable in public settings. Vaccines have benefits as well as risks that are higher for some people because of genetic and other biological differences, as has been demonstrated by the more than $1 billion awarded to vaccine casualties under the National Childhood Vaccine Injury Act of 1986.
Mr. Milloy has reminded us that the people of New Hampshire embrace a liberal informed-consent policy for vaccines that emphasizes education rather than prosecution because they are serious about "Live Free or Die," their state motto, "while too many of us are content to live and die as slaves."
His warning also challenges us to think about an important moral question: Should citizens be injected against their will with biological agents that can injure and kill for what the state has defined as the common good?
How we answer that question may well determine how we define freedom in America in the 21st century.
Barbara Loe Fisher
President
National Vaccine Information Center Vienna
"Legislation mandating the HPV vaccine for pre-adolescent schoolgirls is pending in the District, Maryland and Virginia. Those who advocate it are quick to note that parents can opt out of the program. But few can say exactly how many bureaucratic hoops a parent will have to jump through to do that. Besides, why should the onus be on the parents to figure out how not to be in a government-mandated program? In New Hampshire, parents opt in -- and the burden is on the government to show how the vaccine can benefit their children....So are New Hampshire residents somehow smarter and better able to develop effective public health programs? Are they more concerned about their children than the rest of us? Hardly. What they have that we do not is the right attitude. They take their state motto seriously: "Live Free or Die," while too many of us are content to live and die as slaves." - Courtland Milloy, Washington Post , January 24, 2007, Force Is Not the Only Way to Administer a Vaccine
Barbara Loe Fisher Commentary:
This morning (Feb. 5) on the NBC "Today Show," (see the video HPV Vaccine is mandatory in Texas) Dawn Richardson, the President of PROVE (Parents Requesting Open Vaccine Education) in Texas debated Texas Rep. Jessica Farrar (D) who supports the Executive Order issued by the Republican Governor of Texas, Rick Perry, on Feb. 2 mandating that all sixth grade girls gets three doses of HPV vaccine in order to attend school. Dawn made the point that "the Governor has side stepped policy...there is no way for the people of this state to be able to add input and for the legislature to be able to debate and decide and this is just plain wrong."
Although Dawn was supposed to be only debating the legislator, she ended up also debating NBC doc Nancy Snyderman, who offered her opinion on the intelligence of state legislators when she qualified that she was speaking "as an American citizen" and proclaimed "I never feel better when legislators start arguing about the science. They haven't done a good job with stem cells and they haven't done a good job with basic science and I am not so sure they are going to do a better job with this...."
And therein lies the problem with medical doctors at Merck and medical doctors in state health departments and medical doctors at the CDC and many medical doctors in the U.S. occupying a position of authority (like on TV) : they just can't help telling other people what to do. And they get really, really mad if you don't do what they tell you to do - for your own good and everyone's else's good, of course. Their favorite tactic, when they really don't want you to understand the risks you are about to take with whatever they are telling you to do, is: "You don't understand. You couldn't possibly understand the complexities of this issue. I'll make the decision for you."
Well, Nancy, I've got news for you. The majority of us ordinary non-M.D. Americans believe in our right to fully participate in the creation of the laws which govern us by working through our elected officials, in this case, our state legislators. We don't believe in a medical aristocracy running the show. We actually believe our elected officials, like us, have a brain and can think through these tough issues like whether our pre-adolescent daughters ought to be injected with a vaccine that Merck only tested in a few thousand little girls or whether we should be paying higher health insurance premiums to spend $4 billion to prevent 3700 cervical cancer deaths in the U.S. that could be avoided if women just got pap smears and early treatment of pre-cancerous lesions. We don't think these issues have nearly as much to do about sex (that convenient red herring) as it does about this HPV vaccine's safety, necessity and cost.
The days when Moms (and legislators) bow down to medical doctors and drug companies and offer up their children to every new vaccine that comes down the pike are over. Faith without question rightly belongs in Cathedrals and Temples, but not in the halls of our state Capitols or Congress.
Parents all over America are standing up and shouting now: Show us the Science and Give us a Choice.
Just in time.
LETTERS TO THE EDITOR (Published)
The Washington Post
February 1, 2007
Thanks to columnist Courtland Milloy for his courageous defense of the informed consent ethic, which includes allowing parents to make informed, voluntary vaccination decisions for their children ["Force Is Not the Only Way to Administer a Vaccine," Metro section, Jan. 24]. Mr. Milloy makes the point that if the governed are to respect and have confidence in those who govern them, state officials must treat citizens with respect, rather than using coercion and intimidation to implement health policies.
In addition to the human papillomavirus vaccine, many vaccines are being developed for diseases that depart from the smallpox and polio model and are not transmissable in public settings. Vaccines have benefits as well as risks that are higher for some people because of genetic and other biological differences, as has been demonstrated by the more than $1 billion awarded to vaccine casualties under the National Childhood Vaccine Injury Act of 1986.
Mr. Milloy has reminded us that the people of New Hampshire embrace a liberal informed-consent policy for vaccines that emphasizes education rather than prosecution because they are serious about "Live Free or Die," their state motto, "while too many of us are content to live and die as slaves."
His warning also challenges us to think about an important moral question: Should citizens be injected against their will with biological agents that can injure and kill for what the state has defined as the common good?
How we answer that question may well determine how we define freedom in America in the 21st century.
Barbara Loe Fisher
President
National Vaccine Information Center Vienna
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