"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.
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
CA: New Autism Cases At All Time High
"California is now averaging over 9 new cases of full syndrome autism entering California's DD system a day, seven days a week. 78% of the autism population in the system is under the age of 18, with 84% under the age of 22 years old. We currently have 1,223 more 3 to 5 year olds in the system then we have for ALL ages from 22 years old to 62 years old and beyond. 20 years ago in 1987 there were 2,273 persons with autism in California's system. Today, 20 years later, there are 32,809." - Rick Rollens, Co-founder M.I.N.D. Institute UC-Davis
Barbara Loe Fisher Commentary:
Rick Rollens, co-founder of the M.I.N.D. Institute at UC-Davis and longtime advocate for autism research, has been working with the California legislature since the late 1990's to analyze and report on autism incidence statistics in the state. The first report that California Department of Developmental Services (DDS) issued on autism increase statistics was in April 1999, when DDS reported a 273 percent increase between 1987 and 1998 in the numbers of new children with a professional diagnosis of autism. That groundbreaking report concluded that "the number of persons with autism grew markedly faster than the numbers of persons with other developmental disabilities and "compared to characteristics of 11 years ago, the present population of persons with autism are younger and have a greater chance of exhibiting no or milder forms of mental retardation."
Since that 1999 report, Rick has continued to report on autism diagnosis statistics coming out of the state of California. Yesterday, Rick released another update of how many children are being professionally diagnosed with full spectrum DSM IV autism and have been deemed eligible to receive DDS services. These numbers only represent those children with a full spectrum autism diagnosis and not those with Asperger's, developmental delays or other autism spectrum disorders.
The latest news from California is that during the calendar year of 2006, California added more new cases of autism to the DDS system than have ever been added to the system in any calendar year. The 3,385 full spectrum autism cases that were professionally diagnosed and added to the system in 2006 represent a 16 percent increase over calendar year 2005.
The autism epidemic in California is getting worse. It is an epidemic that is not just confined to California.The autism epidemic, which is part of the larger chronic disease and disability epidemic affecting so many of our children, perfectly coincides in the past two decades with the doubling of the number of doses of vaccines young children get in the first six years of life. In 1987, by age six children had received 23 doses of seven vaccines. Today, by age six children receive 48 doses of 14 vaccines at a time when their immune systems and brains are developing most rapidly.
Constant atypical manipulation of the immune system with lab-altered viral and bacterial vaccines containing many different additives may well be harming an expanding number of children, who are biologically vulnerable to vaccine-induced chronic inflammation and neuroimmune dysfunction. The tragedy of one-size-fits-all vaccine policies enforced by the law is that an unknown number of vulnerable children are being written off as expendable in the name of the "common good." How many of the growing numbers of autistic children are among the biologically vulnerable, who cannot handle the 48 doses of 14 vaccines the CDC and AAP tell doctors to give them?
Answering this question requires scientific investigation that goes far beyond the mercury hypothesis.
CALIFORNIA REPORTS RECORD AUTISM INCREASES
by Rick Rollens
According to information recently released by the California Department of Developmental Services (DDS) during calendar year 2006, California added 3,385 new cases of professionally diagnosed, full syndrome autism to it's developmental services system. This represents the most new cases ever added to the system in a one year period, and a 16% increase over calendar year 2005.
Also, DDS reports that an all time record number of new intakes came into the system during one quarter in the 38 year history of California's DD system during the fourth quarter of 2006 (October through December) when 956 new cases entered the system. The previous record was 846.
(Keep in mind, that all of the data reported by DDS, ONLY includes persons with professionally diagnosed full syndrome DSM IV autism, and DOES NOT include persons with PDD, NOS, Asperger's Syndrome or any other autism spectrum disorder.)
California is now averaging over 9 new cases of full syndrome autism entering California's DD system a day, seven days a week.
78% of the autism population in the system is under the age of 18, with 84% under the age of 22 years old.
We currently have 1,223 more 3 to 5 year olds in the system then we have for ALL ages from 22 years old to 62 years old and beyond.
20 years ago in 1987 there were 2,273 persons with autism in California's system. Today, 20 years later, there are 32,809.
By the end of 2002, 39% of all new intakes were full syndrome autism cases. Four years later at the end of 2006, autism now accounts for 64% of all new intakes. Therefore, today over 6 out of 10 persons entering California's DD system have full syndrome autism, and less then four persons entering the system have mental retardation, cerebral palsy, and epilepsy COMBINED!
Below is a chart comparing the age distribution of the autism population for the four year period between 12/02 and 12/06 with percentage comparisons broken down by age group as the part of the whole for 12/02 and 12/06, and the percentage increase by age group between 12/02 and 12/06:
DECEMBER 2002
3-5 year olds 4039 * (20%)
6-9 year olds 5884 (29%)
10-13 year olds 3733 (18%)
14-17 year olds 1825 (9%)
18-21 year olds 1118 (5%)
22 to 62 and older 3762 (18%)
TOTAL: 20,377
DECEMBER 2006
3-5 year olds 6348 (19%) ** 36%
6-9 year olds 8782 (27%) 33%
10-13 year olds 6312 (19%) 41%
14-17 year olds 4108 (13%) 56%
18-21 year olds 2102 (6%) 47%
22 to 62 and older 5125 (16%) 27%
TOTAL: 32,809
* = % OF WHOLE FOR THAT YEAR
** = % INCREASE OVER FOUR YEARS
Barbara Loe Fisher Commentary:
Rick Rollens, co-founder of the M.I.N.D. Institute at UC-Davis and longtime advocate for autism research, has been working with the California legislature since the late 1990's to analyze and report on autism incidence statistics in the state. The first report that California Department of Developmental Services (DDS) issued on autism increase statistics was in April 1999, when DDS reported a 273 percent increase between 1987 and 1998 in the numbers of new children with a professional diagnosis of autism. That groundbreaking report concluded that "the number of persons with autism grew markedly faster than the numbers of persons with other developmental disabilities and "compared to characteristics of 11 years ago, the present population of persons with autism are younger and have a greater chance of exhibiting no or milder forms of mental retardation."
Since that 1999 report, Rick has continued to report on autism diagnosis statistics coming out of the state of California. Yesterday, Rick released another update of how many children are being professionally diagnosed with full spectrum DSM IV autism and have been deemed eligible to receive DDS services. These numbers only represent those children with a full spectrum autism diagnosis and not those with Asperger's, developmental delays or other autism spectrum disorders.
The latest news from California is that during the calendar year of 2006, California added more new cases of autism to the DDS system than have ever been added to the system in any calendar year. The 3,385 full spectrum autism cases that were professionally diagnosed and added to the system in 2006 represent a 16 percent increase over calendar year 2005.
The autism epidemic in California is getting worse. It is an epidemic that is not just confined to California.The autism epidemic, which is part of the larger chronic disease and disability epidemic affecting so many of our children, perfectly coincides in the past two decades with the doubling of the number of doses of vaccines young children get in the first six years of life. In 1987, by age six children had received 23 doses of seven vaccines. Today, by age six children receive 48 doses of 14 vaccines at a time when their immune systems and brains are developing most rapidly.
Constant atypical manipulation of the immune system with lab-altered viral and bacterial vaccines containing many different additives may well be harming an expanding number of children, who are biologically vulnerable to vaccine-induced chronic inflammation and neuroimmune dysfunction. The tragedy of one-size-fits-all vaccine policies enforced by the law is that an unknown number of vulnerable children are being written off as expendable in the name of the "common good." How many of the growing numbers of autistic children are among the biologically vulnerable, who cannot handle the 48 doses of 14 vaccines the CDC and AAP tell doctors to give them?
Answering this question requires scientific investigation that goes far beyond the mercury hypothesis.
CALIFORNIA REPORTS RECORD AUTISM INCREASES
by Rick Rollens
According to information recently released by the California Department of Developmental Services (DDS) during calendar year 2006, California added 3,385 new cases of professionally diagnosed, full syndrome autism to it's developmental services system. This represents the most new cases ever added to the system in a one year period, and a 16% increase over calendar year 2005.
Also, DDS reports that an all time record number of new intakes came into the system during one quarter in the 38 year history of California's DD system during the fourth quarter of 2006 (October through December) when 956 new cases entered the system. The previous record was 846.
(Keep in mind, that all of the data reported by DDS, ONLY includes persons with professionally diagnosed full syndrome DSM IV autism, and DOES NOT include persons with PDD, NOS, Asperger's Syndrome or any other autism spectrum disorder.)
California is now averaging over 9 new cases of full syndrome autism entering California's DD system a day, seven days a week.
78% of the autism population in the system is under the age of 18, with 84% under the age of 22 years old.
We currently have 1,223 more 3 to 5 year olds in the system then we have for ALL ages from 22 years old to 62 years old and beyond.
20 years ago in 1987 there were 2,273 persons with autism in California's system. Today, 20 years later, there are 32,809.
By the end of 2002, 39% of all new intakes were full syndrome autism cases. Four years later at the end of 2006, autism now accounts for 64% of all new intakes. Therefore, today over 6 out of 10 persons entering California's DD system have full syndrome autism, and less then four persons entering the system have mental retardation, cerebral palsy, and epilepsy COMBINED!
Below is a chart comparing the age distribution of the autism population for the four year period between 12/02 and 12/06 with percentage comparisons broken down by age group as the part of the whole for 12/02 and 12/06, and the percentage increase by age group between 12/02 and 12/06:
DECEMBER 2002
3-5 year olds 4039 * (20%)
6-9 year olds 5884 (29%)
10-13 year olds 3733 (18%)
14-17 year olds 1825 (9%)
18-21 year olds 1118 (5%)
22 to 62 and older 3762 (18%)
TOTAL: 20,377
DECEMBER 2006
3-5 year olds 6348 (19%) ** 36%
6-9 year olds 8782 (27%) 33%
10-13 year olds 6312 (19%) 41%
14-17 year olds 4108 (13%) 56%
18-21 year olds 2102 (6%) 47%
22 to 62 and older 5125 (16%) 27%
TOTAL: 32,809
* = % OF WHOLE FOR THAT YEAR
** = % INCREASE OVER FOUR YEARS
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