Friday, December 12, 2008

Vaccines Get New Scrutiny

Vaccines Get New Scrutiny
Vaccinations are supersafe, but maybe not all at once, or for certain children
By Deborah Kotz

Posted December 11, 2008

When Julie Austin decided to give her daughter the Gardasil vaccine, she desperately wanted to protect Sara, then 15, from the human papillomavirus that had caused abnormal Pap smears in other family members. A day after the shot, however, Sara complained that she was dizzy and her head was pounding. "Her doctor said the migraine—the first one Sara ever experienced—could have been caused by Gardasil, but it faded the next day, so I didn't worry," says Austin, of Westfield, Mass. But the headache struck again after Sara's second shot—and again after her third. Then, the crushing pain became constant, causing Sara to miss school, quit the soccer team, and spend weekends in bed.

Now worried. Might Gardasil be to blame for Sara Austin's severe headaches?

Her mom now wonders if she made the right decision to vaccinate, even though the Food and Drug Administration insists there's no reason to be worried about Gardasil. "We're monitoring the safety of the HPV vaccine very carefully, and the only adverse event that causes some concern is syncope or fainting," says Robert Ball, director of the FDA's office of biostatistics and epidemiology. And Gardasil's benefits can't be ignored: It protects against several dangerous HPV strains, including those responsible for the bulk of cervical cancers. But others in the medical establishment believe Gardasil's safety hasn't yet been proven and question why it's being recommended for girls as young as 9. "I certainly think it's wrong to give [Gardasil] to young teenage girls," contends pediatrician Catherine DeAngelis, editor in chief of the Journal of the American Medical Association. "What are the risks? We won't know until it's given to millions of women." Karameh Hawash, the pediatric neurologist who recently treated Sara Austin with a prescription migraine drug, says she has seen two other girls stricken by daily headaches after receiving Gardasil shots.

Such uncertainty explains the decibel level of the battle cries both defending and attacking vaccines, which has risen in recent years along with the number of immunizations children face: 38 shots against 15 diseases before kindergarten, compared with 11 shots against eight diseases 15 years ago. There's no question that vaccines have been lifesaving: If every American child followed the recommended schedule, some 33,000 lives would be saved, 14 million infections prevented, and $10 billion slashed from healthcare costs every year, according to the Centers for Disease Control and Prevention. But plenty of parents are unconvinced by the public-health mission, given other data—also from the CDC—showing that about 30,000 "adverse events" are reported every year by doctors and patients, of which 3,000 to 4,500 are serious enough to cause hospitalization, life-threatening illness, or even death. While the CDC's associate director for immunization safety, John Iskander, insists that "vaccines are extraordinarily safe medical products," he also acknowledges that the "trade-off between risks and benefits can be very difficult for parents."

Certainly, the government has taken steps through the years to make vaccines safer, replacing the live pertussis component of the diphtheria-tetanus-pertussis vaccine, which caused high fevers and seizures in some children, with the inactive virus, for example. At the same time, though, officials are targeting an ever-expanding array of diseases. Some parents, fighting against the more-is-better philosophy, have gone so far as to organize chickenpox parties in the belief that infecting their kids the "natural way" is safer than vaccination with a weakened form of the virus; others, fearful that vaccines have led to the rise in autism, choose not to vaccinate at all. Alarmed, the American Academy of Pediatrics in September formed an "immunization alliance" with other medical groups to push for kids to get all recommended vaccines on time. Public schools are pushing harder, too; one Maryland school district threatened to bring criminal charges against noncompliant parents.

Call for study. Far more quietly, the government is acknowledging that, at the moment, science doesn't know much about how many shots a kid can safely get at once and which children will be harmed. Last March, the family of 9-year-old Hannah Poling won a claim in the federal Vaccine Court (created to protect manufacturers from ruinous lawsuits) that the autism she developed as a toddler was most likely triggered by receiving five shots against nine diseases in one day; all told, the government has paid out more than $900 million for vaccine injuries over the past two decades. Since the Poling verdict, the government has called for new safety studies—to evaluate, say, whether gene variations may make some kids more susceptible to vaccine injury. "If we can show that individuals of a certain genetic profile have a greater propensity for developing adverse events, we may want to screen everyone prior to vaccination," says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, a key partner in the new initiative.

The concern that vaccines might trigger autism was first sparked a decade ago by a British study—since refuted—showing that the measles part of the measles-mumps-rubella shot caused intestinal inflammation and allowed toxins to enter the bloodstream and attack the central nervous system. Other experts speculated that thimerosal, a preservative containing mercury, was the culprit, and it was removed from children's vaccines in 2001 (though most flu vaccines still contain it). The CDC is currently conducting a study of 1,200 children to see whether a thimerosal-autism link really does exist, while some scientists wonder whether a small percentage of cases are, like Hannah Poling's, triggered by multiple vaccinations. Poling was found to have mitochondrial disease, a nerve disorder causing autismlike symptoms that appeared to be brought on by her immunizations. "Mitochondrial disease often occurs in the later stages of a viral illness, and it's proper reasoning to think that vaccines could do what viruses do," in terms of immune reactions, says neurologist Bruce Cohen, a mitochondrial disease expert at the Cleveland Clinic.

A search for markers. The answer could lie in gene studies. "We'd like to know if there are particular markers that signal undetectable diseases like a subclinical mitochrondrial disorder," says Fauci. A 2007 study already found that certain mutations affect a person's susceptibility to fevers after smallpox vaccination; the researchers say they may also predict other responses, like febrile seizures linked to the MMR vaccine.

It's important to keep the risks in perspective: More than 95 percent of kids sail through their shots with, at most, a little fussiness, according to Renee Jenkins, president of the American Academy of Pediatrics. A small percentage experience an overactive immune response like redness, swelling, or pain at the injection site, high fever, or extreme irritability, but severe complications like anaphylactic shock are extremely rare (see graphic). Still, how to account for the fact that once familiar diseases like measles and mumps have become nearly as rare as the adverse reactions?

"It's one thing to take a risk [with a medication] if you actually have a disease, but taking a risk when the goal is prevention of a very rare disease is less tolerable," says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. Menactra, for example, protects against bacterial meningitis, which strikes about 1 in 100,000 people per year and kills about 1 in a million. But it also may cause Guillain-Barré syndrome, a temporary but severe paralysis triggered by an overactive immune system, in 1 to 2 teens per million who are vaccinated, according to Iskander.

New vaccines like Menactra and Gardasil pose unknown safety risks because, like any drug submitted for FDA approval, they only need to be tested in several thousand people. "These trials simply aren't big enough to detect rare events that only come to light after 1 million or more doses are distributed," says Iskander. The original vaccine against rotavirus, which causes severe diarrhea and dehydration in infants, was tested on fewer than 1,300 American infants before it was approved in 1998; a year later, after being given to 1.5 million babies, RotaShield was pulled from the market because 13 reported cases of severe intestinal blockages were attributed to the vaccine. The meningitis vaccine Menactra was studied in just over 7,500 people before it was approved in 2005 for adults and kids over age 11. It wasn't until last February, after 15 million doses had been administered, that the CDC announced a "small increased risk" of Guillain-Barré that needs to be studied further.

Hit or miss. The CDC's current system of detecting rare problems is hit or miss. Perhaps the crudest tool is the Vaccine Adverse Event Reporting system, which relies on doctors and patients to file a report if they suspect symptoms have been caused by a vaccine. Many problems filed with VAERS have nothing to do with vaccinations; real adverse events often go unreported. A better monitoring system, the agency's Vaccine Safety Datalink, regularly scans 5.5 million anonymous health records provided by managed care organizations to see whether new vaccines are associated with a spike in certain conditions. Still, even the Datalink database doesn't hold enough teens to definitively prove a causal link between Guillain-Barré and Menactra, says Harvard Medical School professor and vaccine researcher Richard Platt. He and his colleagues recently established a surveillance system that includes 50 million people and are using it to check for Menactra-related Guillain-Barré cases in more than 9 million young people ages 11 to 21. Platt expects to publish results sometime in 2009.

This larger surveillance system could also help determine whether there's a limit to the number of immunizations a baby can safely have at once. The Institute of Medicine concluded in 2002 that giving babies 20 shots against 11 diseases before age 2 did not raise the risk of juvenile diabetes (thought to be a result of an immune system in overdrive). But the IOM decided there wasn't enough evidence to prove or disprove an increased risk of allergies and asthma. Efforts are underway in Congress to fund a well-designed study comparing vaccinated kids against those who remain unvaccinated to see if there are differences in autism rates.

Avoiding immunizations altogether certainly isn't a good solution for families, because meningococcal, pertussis, and other infections could sharply rise if vaccination rates drop low enough—putting any unvaccinated child at risk. Measles cases rose recently in counties with the lowest vaccination rates. So, parents who choose not to vaccinate better hope that other parents aren't following their lead. Certain approaches, though, can help minimize risks without leaving children unprotected.

While researchers seek answers, some families are left wondering if their tragedies are vaccine-caused. Philip Tetlock, an organizational behavior professor at University of California—Berkeley's Haas School of Business, is desperately trying to determine if his 14-year-old daughter Jenny's juvenile amyotrophic lateral sclerosis (aka Lou Gehrig's disease) is a result of her Gardasil vaccination. Another young woman, Whitney Baird, 22, died in August from this disease, just 13 months after receiving Gardasil. Both were healthy before getting the shot, and the condition is extraordinarily rare, affecting just 1 in every 2 million people. The cases have been reviewed by CDC researchers who, says Iskander, "didn't feel that vaccines were the likely trigger." Yet Barbara Shapiro, an associate professor of neurology at Case Western Reserve University School of Medicine who has also pored over Jenny's and Whitney's medical records, believes the cases raise red flags.

Often, parents' only recourse is to try to collect damages in the Vaccine Court, which is expected to rule on a series of autism cases any day. Tawny Buck had to fight hard to convince the court that her infant daughter Quincy's seizures, which left the now-13-year-old with severe brain damage, were caused by a reaction to the live pertussis vaccine. Currently serving in a government vaccine-safety working group, Buck, of Wasilla, Alaska, hopes her experience can help make a difference when it comes to setting research priorities for the CDC. "Vaccines are important for keeping our communities safe, but they have problems," she says. "What happened to my daughter can't be forgotten."

Monday, November 24, 2008

***Mercury Emissions Up at Coal-Burning Power Plants***

***Mercury Emissions Up at Coal-Burning Power Plants***

*WASHINGTON, DC*, November 21, 2008 (ENS) -
http://www.ens-newswire.com/ens/nov2008/2008-11-21-092.asp

The top 50 most-polluting coal-burning power plants in the United States emitted 20 tons of toxic mercury into the air in 2007, finds a new report from the nonprofit Environmental Integrity Project. Of the top 10 mercury emitting power plants, all but one reported an increase as compared to 2006.

Once released into the atmosphere, mercury settles in lakes and rivers, where it moves up the food chain to humans who eat contaminated fish.

The Centers for Disease Control has found that six percent of American women have mercury in their blood at levels that would put a fetus at risk of neurological damage.

Mercury's harmful effects that may be passed from the mother to the fetus include brain damage, mental retardation, incoordination, blindness, seizures, and inability to speak, according to the federal Agency for Toxic Substances. Children poisoned by mercury may develop problems of their nervous and digestive systems, and kidney damage.

More Southern Company power plants are among the dirtiest mercury emitters than those of any other company, according to the report, which is based on data reported to the U.S. Environmental Protection Agency.

Southern Company's Miller power plant, in Jefferson County, Alabama, tops the list of mercury emitters, reporting nearly a ton of mercury air pollution in 2007, the most recent period for which data is available. This represents a 13.57 percent increase over the plant's 2006 reported emissions.

In April 2006, the plant's operator, Alabama Power, announced it would spend $200 million to remove nitrogen oxide emissions by 2008 and sulfur dioxide emissions by 2011, but no mercury removal technology has been announced for the Miller plant.

In total, eight Southern Company plants in Georgia and Alabama are ranked among the top 50 power plant mercury emitters.

The dozen states with plants emitting the most mercury are - in order from highest to lowest - Texas, Pennsylvania, Alabama, Georgia, Ohio, Indiana, North Dakota, Missouri, Kansas, North Carolina, Wisconsin and Arkansas.

Texas power plants hold five slots among the nation's highest 10 mercury emitters.

From Austin, Environmental Integrity Project attorney Ilan Levin said, "When the original Clean Air Act was passed in 1970, the electric utility industry persuaded Congress to not impose strict pollution controls on old power plants, because they would soon be replaced by newer state-of-the-art facilities. Yet despite the
industry's promises, many of the nation's oldest and dirtiest power plants continue to operate."

"Pollution controls that dramatically reduce emissions are widely available, and already being used at many plants," said Levin. "But, until the public and policymakers hold the electric utility industry to its promised cleanup of the nation's oldest and dirtiest power plants, Americans will continue to bear unnecessary health and environmental costs."

The Environmental Integrity Project report says, "Activated carbon injection, which is commercially available and has been tested through the Department of Energy's Clean Coal Power Initiative, can achieve mercury reductions of 90 percent on both bituminous and sub-bituminous coals."

"In addition," the report says, "mercury can be significantly reduced as a co-benefit of controls for other pollutants, such as fabric filters, sulfur dioxide scrubbers, and selective catalytic reduction."

Jan Jarrett, president and chief executive of Citizens for Pennsylvania's Future, said, "These continued high mercury emissions from Pennsylvania plants clearly demonstrate the need for Pennsylvania's state-specific mercury rule that was adopted in February of 2007."

"Our rule requires an 80 percent reduction in mercury emissions from power plants by 2010 and a 90 percent reduction by 2015 and does not allow power plants to trade toxic mercury emissions," he said.

Coal-fired power plants are the single largest source of mercury air pollution, accounting for roughly 40 percent of all mercury emissions nationwide, according to the U.S. Environmental Protection Agency. The mercury they emit is affecting national parks, warns Bart Melton, an analyst with the nonprofit National Parks Conservation Association.

"National parks across the U.S. suffer from high concentrations of mercury pollution - a key source of which are coal-fired power plants. At the Great Smoky Mountains, mercury pollution is continually showered over the park, and then works its way up the food chain, threatening the health of park visitors and wildlife," Melton said. "We need to shut off the toxic mercury spigot at coal-fired power plants to keep national park visitors and wildlife healthy."

While some of the dirtiest plants are reporting reductions in mercury emissions since 2006, the majority of the worst 50 plants increased their mercury emissions through 2007.

In 2005, over the objections of environmentalists, the U.S. EPA introduced a weak cap-and-trade rule, which would have allowed power plants to either reduce their own mercury pollution or buy pollution credits from other plants. In February 2008, a federal appeals court ruled that EPA's approach to power plant mercury emissions violates the Clean Air Act, and vacated the EPA regulation.

The Environmental Integrity Project was established in March 2002 to advocate for more effective enforcement of environmental laws. The organization was founded by Eric Schaeffer, who served as director of the U.S. Environmental Protection Agency's Office of Regulatory Enforcement. Schaeffer resigned in 2002 after publicly expressing his frustration with efforts of the Bush administration to weaken enforcement of the Clean Air Act and other environmental laws.

Thursday, November 20, 2008

Vaccine Injury Compensation: A Failed Experiment in Tort Reform?

Vaccine Injury Compensation: A Failed Experiment in Tort Reform?
by Barbara Loe Fisher, from the NVIC newsletter.

On Nov. 14, 1986, President Ronald Reagan signed the NationalChildhood Vaccine Injury Act of 1986 into law, instituting first-timevaccine safety reforms in the U.S. vaccination system and creating thefirst no-fault federal vaccine injury compensation program alternativeto a lawsuit against vaccine manufacturers and pediatricians.

Twenty-two years later, on Nov. 18, 2008,I made a statement (Statement— Barbara Loe Fisher, Nov 18, 2008 — Advisory Commission on ChildhoodVAccines) to the Advisory Commission on Childhood Vaccines (ACCV) andquestioned whether the compensation program is fatally flawed and sobroken that it should be repealed.

Many parents are wondering whetherit would be better to return to civil court without restrictions tosue vaccine manufacturers and doctors for injuries and deaths their children suffered after receiving federally recommended vaccines. During its two-decade history, two out of three individuals applyingfor federal vaccine injury compensation have been turned awayempty-handed even though to date $1.8B has been awarded to more than2,200 plaintiff's out of some 12,000 who have applied.

Today, nearly5,000 vaccine injury claims are sitting in limbo because they represent children, who suffered brain and immune system dysfunction after vaccination but have been diagnosed with regressive autism,which is not recognized by the program as a compensable event. There is $2.7B sitting in the Trust Fund which could have been awarded tovaccine victims.At the time of the law's creation in 1986, Congress said they werecommitted to setting up a fair, expedited, non-adversarial, lesstraumatic, less expensive no-fault compensation mechanism alternativeto civil litigation. But Congress also acknowledged that anylegislation providing liability protection must also be equallycommitted to preventing vaccine harm.

The Act contains strong safetyprovisions, including first-time mandates for doctors to record andreport serious health problems, hospitalizations, injuries and deathsafter vaccination and give parents written benefit and risk information before a child is vaccinated. But few of the safety provisions have been enforced and, as Itestified in Congress in 1999 and again at the Nov. 18 ACCV meeting,there has been a betrayal of the promise that was made to parentsabout how the compensation program would be implemented.

Obtaining compensation has become a highly adversarial, time-consuming,traumatic and expensive process for families of vaccine injured children and far too many vaccine victims have been denied compensation while vaccine makers and doctors have enjoyed liability protection and dozens of doses of nine new vaccines have been added tothe childhood vaccine schedule.I pointed out that federal court judges are beginning to look back atthe legislative history of the Act, which so clearly affirms theintent of Congress when creating it.

In recent court decisions, judgeshave agreed with parents and their attorneys that the compensation program has become far too difficult for plaintiffs. A recent stateSupreme Court ruling also reiterated that Congress never intended toshield vaccine manufacturers from ALL liability for vaccine injuriesand deaths when it could be demonstrated that a safer product couldhave been marketed.In a Supreme Court of Georgia ruling on October 6, 2008 in AmericanHome Products v. Ferrari, the justices unanimously held that theNational Childhood Vaccine Injury Act does not give a vaccine manufacturer blanket immunity from vaccine injury lawsuits if it canbe proven that the company could have made a safer vaccine.

Georgia Supreme Court Justice George Carley wrote that the 1986 law and "thecongressional intent behind it shows that the Vaccine Act does notpre-empt all design defect claims." He added that Congress did not"use language which indicates that use of the compensation system ismandatory" but only "an appealing alternative" to the courts. Justice Carley wrote that there is no evidence that "FDA approvalalone renders a vaccine unavoidably safe" and said "We hesitate tohold that a manufacturer is excused from making changes it knows willimprove its product merely because an older, more dangerous versionreceived FDA approval," adding that to do so would have "the perverseeffect" of granting complete immunity from liability to an entireindustry and he concluded that "in the absence of any clear andmanifest congressional purpose to achieve that result, we must rejectsuch a far-reaching interpretation. "During the ACCV meeting, longtime plaintiff's attorney Sherry Drewgave a moving description of the suffering that families with vaccineinjured children endure and, during public comment at the end of themeeting, Jim Moody, of SafeMinds, and Vicky Debold, RN, PhD joined mein urging the Committee to recommend to the new Secretary of DHHS thatmore vaccine injured children be compensated.

This was echoed byoutgoing parent ACCV member Tawny Buck, of Alaska, who has a DPTvaccine injured daughter and new ACCV parent member Sarah Hoiberg, ofFlorida, who has a DTaP vaccine injured daughter.In the 1986 Vaccine Injury Act, the Institute of Medicine was directedto review the medical literature for scientific evidence that vaccines can cause injury and death, which resulted in landmark reports toCongress in 1991 and 1994 providing that evidence. IOM announced atthe ACCV meeting that it has recently been contracted by the Health Resources & Services Administration (HRSA) to assemble a Committee of scientific experts to review of the medical literature for evidenceregarding the biological mechanisms for injury and death inassociation with varicella zoster (chicken pox), hepatitis B,meningococcal and HPV vaccine.

There will be several public workshopsduring the Committee's two- year study.NVIC has been calling for basic science research into the biologicalmechanisms of vaccine injury and death for more than two decades.Without understanding how and why vaccines can cause brain and immunesystem dysfunction, there will be no way to develop pathologicalprofiles to help scientifically confirm whether or not an individualhas been injured or died from vaccination.The truth about vaccine risks lies in the science, properly designedand conducted.

The upcoming IOM review may be hampered by a lack ofbiological mechanism studies published in the medical literature butthe review is also an opportunity to point the way to fill in thosegaps in knowledge and the need for additional research that could become part of a national vaccine safety research agenda.In the absence of scientific certainty, all children who regress intopoor health after vaccination should be given a fair hearing in the federal vaccine injury compensation program and generously compensatedwhen no other plausible cause can be found for what happened to themafter vaccination. Congress intended the vaccine injury compensationprogram to be non-adversarial, fair, generous and humane. If it cannot function the way it was intended to function, then parents have everyright to call for its repeal and a return to unrestricted lawsuits.

Sunday, July 20, 2008

Norman Trascript - Vaccinations

Published July 19, 2008 12:00 am - EDITOR'S NOTE: This is the first in a series of articles examining issues surrounding immunizations.

Parents have questioned the side effects of vaccines for years, but the number of parents nationally who opt out of getting their children vaccinated appears to be rising.

Shots or not: Weighing the risks


By Julianna Parker

EDITOR'S NOTE: This is the first in a series of articles examining issues surrounding immunizations.

Parents have questioned the side effects of vaccines for years, but the number of parents nationally who opt out of getting their children vaccinated appears to be rising.

The percent of children ages 19-35 months who are up-to-date on their recommended immunizations nationally decreased from 80.8 percent in 2006 to 80.6 percent in 2007, according to the United Health Foundation.

Currently, nearly 0.5 percent of kids enrolled in U.S. schools are unvaccinated under a medical waiver; 2 to 3 percent have a nonmedical one, according to a June 2 Time Magazine article.

There are some risks to vaccinations, but it's important also to compare those with the risk of contracting the disease, said Dr. Gary E. Raskob, dean of the University of Oklahoma College of Public Health and professor of biostatistics, epidemiology and medicine.

"Most public health professionals would say that the downside of withholding the vaccine from your child is much bigger than the (vaccine's) risk," he said.

One of the main risks that critics of immunization point out is the link between vaccines and autism.

It has long been suspected that thimerosal, which was used as a preservative in some vaccines, caused autism. In 2001, thimerosal was taken out of all vaccinations except traces in some flu vaccines.

But the prevalence of autism hasn't decreased.

In 2003, a committee from the Centers for Disease Control and the National Institutes of Health researched the alleged link between thimerosal and autism and concluded that there was no scientific evidence to support it, according to the Time Magazine story.

The committee also said it did "not consider a significant investment in studies of the theoretical vaccine-autism connection to be useful."

Raskob cautioned that when assessing the risks of immunization, one shouldn't just look at the possible side effects of the vaccine. One should also examine the possible consequences of catching the disease that the shot vaccinates against.

Most parents today who are faced with the question of immunization have not seen the devastating effects of diseases such as measles or polio.

Parents may not know what these diseases are because the vaccinations have virtually eradicated them, Raskob said.

Norman Transcript - The Rogers family

Shots or not: Parents pass on vaccines

EDITOR'S NOTE: This is part of a series of articles examining issues surrounding immunizations.

By Meghan McCormick

Transcript Staff Writer

Meet Brian Rogers and he seems just like any other 6-year-old boy his age.

He spends summer days at the neighborhood pool, and it's hard to get his attention when he's focused on his favorite computer game Monopoly.

Brian likes to talk about his birthday party last month at Pump It Up, the inflatable party zone. The party included laughter, fun and of course, a Monopoly theme cake.

His parents Bill and Sheri Rogers didn't mind the festivities because it wasn't that long ago that their youngest son wouldn't have understood the intentions of the celebration. That's because Brian is autistic.

Both parents believe vaccines played a contributing factor in his and his older brother's condition. The oldest son, Brandon, 8, was diagnosed at age 3 with sensory integration dysfunction.

"I feel because I didn't question it, my children are paying the price," Sheri Rogers said.

The mother said she had both her children vaccinated until recently.

"We are not anti-vaccine," the mother said.

Instead, the couple want toxins removed from doses and the number of immunizations reduced. The mother and father believe it would be best for physicians to delay vaccines until a child's immune system is more mature and to spread out an injection schedule. Scientists should conduct additional testing on vaccines to make sure they are safe to inject in people, they say.

The parents have no intentions of updating their children's vaccines anytime soon.

"We're not vaccinating further because of the problems our children displayed," she said.

The mother said both boys are students at Roosevelt Elementary School and immunization exemption forms are on file for their sons.

Friday, June 20, 2008

CDC: Vaccine Study Design "Uninformative and Potentially Misleading"

David Kirby

CDC: Vaccine Study Design "Uninformative and Potentially Misleading"

Posted June 20, 2008 | 06:43 PM (EST)

CDC Director Dr. Julie Gerberding has delivered a potentially explosive report to the powerful House Appropriations Committee, in which she admits to a startling string of errors in the design and methods used in the CDC's landmark 2003 study that found no link between mercury in vaccines and autism, ADHD, speech delay or tics.

Gerberding was responding to a 2006 report from the National Institute of Environmental Health Sciences (NIEHS), which concluded that the CDC's flagship thimerosal safety study was riddled with "several areas of weaknesses" that combined to "reduce the usefulness" of the study.

"CDC concurs," Dr. Gerberding wrote in an undated mea culpa to Congress, (provided to me through a Capital Hill staffer) adding that her agency "does not plan to use" the database in question, the Vaccine Safety Datalink, (VSD) for any future "ecological studies" of autism.

In fact, Gerberding's report said, any continued use of the VSD for similar ecological studies of vaccines and autism "would be uninformative and potentially misleading."

Ecological vaccine studies are large, epidemiological analyses of risks and trends using computerized data from large populations -- in this case children enrolled at several big HMOs -- without ever examining a single patient in person.

CDC officials conducted at least five separate analyses of the data over a four-year period from 1999-2003. The first analysis showed that children exposed to the most thimerosal by one month of age had extremely high relative risks for a number of outcomes, compared with children who got little or no mercury: The relative risk for ADHD was 8.29 times higher, for autism, it was 7.62 times higher, ADD, 6.38 times higher, tics, 5.65 times, and speech and language delays were 2.09 more likely among kids who got the most mercury.

Over time, however, all of these risks declined into statistical insignificance, statistical inconsistency or else outright oblivion: The relative risk for autism plummeted from 7.62 in the first analysis, to 2.48 in the second version, to 1.69 in the third round, to 1.52 in the fourth, and down to nothing at all in the fifth, final, and published analysis printed in the Journal Pediatrics in November of 2003.

Vaccine officials attributed the steady drop to the elimination of "statistical noise" from the data through due diligence and the endeavor for excellence in governmental statistical analysis.

Indeed, the VSD study was the main pillar of a hugely influential 2004 report by the Institute of Medicine, which also concluded that there was no evidence of link between mercury, vaccines and autism.

To this day, public health officials routinely point to five "large epidemiological studies" representing the "highest quality science," none of which found any link to thimerosal.

In fact, the American VSD study has long been held up as the best and brightest of them all (the others were in Sweden, the UK, and two in Denmark). And this reputation has stuck in the minds of medicine and the media.

Curiously though, even the study's lead author -- Dr. Thomas Verstraeten, an employee of vaccine maker GlaxoSmithKline -- protested that the VSD study "found no evidence against an association, as a negative study would. In fact, he said that additional study was needed, which "is the conclusion to which a neutral study must come."

That's when Congress stepped in.

In 2005, a group of Senators and Representatives headed by Sen. Joe Lieberman wrote to the NIEHS (an agency of the National Institutes of Health) saying that many parents no longer trusted the CDC to conduct independent minded studies of its own vaccine program. Lieberman et al asked NIEHS to review the CDC's work on the vaccine database and report back with critiques and suggestions.

The final NIEHS report was a serious and thoughtful critique of where the CDC went wrong in its design, conduct and analysis of the study. The NIEHS panel "identified several serious problems," with the CDC's effort, criticism to which the agency had not responded -- until now.

In her letter to the House Appropriations Committee, the CDC Director responded directly to many -- though not all -- of the most important criticisms and recommendations contained in the NIEHS panel report.

For example, the NIEHS had criticized CDC for failing to account for other mercury exposures, including maternal sources from flu shots and immune globulin, as well as mercury in food and the environment.

"CDC acknowledges this concern and recognizes this limitation," the Gerberding reply says.

The NIEHS also took CDC to task for eliminating 25% of the study population for a variety of reasons, even though this represented, "a susceptible population whose removal from the analysis might unintentionally reduce the ability to detect an effect of thimerosal." This strict entry criteria likely led to an "under-ascertainment" of autism cases, the NIEHS reported.

"CDC concurs," Gerberding wrote, again noting that its study design was "not appropriate for studying this vaccine safety topic. The data are intended for administrative purposes and may not be predictive of the outcomes studied."

Another serious problem was that the HMOs changed the way they tracked and recorded autism diagnoses over time, including during the period when vaccine mercury levels were in decline. Such changes could "affect the observed rate of autism and could confound or distort trends in autism rates," the NIEHS warned.

"CDC concurs," Dr. Gerberding wrote again, "that conducting an ecologic analysis using VSD administrative data to address potential associations between thimerosal exposure and risk of ASD is not useful."

Read that sentence one more time. The head of the CDC is saying that its most powerful and convincing piece of exonerating evidence for thimerosal is, in effect, "useless."

I hope everyone will read it, including the recommendations to make the VSD better, and the CDC's agreement with all of the suggestions.

As questionable at the US thimerosal study was, "it was an improvement on other studies, including the two in Denmark, both of which had serious weaknesses in their designs," Dr. Irva Hertz-Picciotto, Professor of Public Health at UC Davis Medical School and Chair of the NIEHS panel, told reporter Dan Olmsted at UPI.

That leaves very little for the CDC to go on in terms of proving that thimerosal and autism are not associated in any way.

Yes, there is always the study of disability services data from California -- which seem to be rising among the youngest cohorts of kids, who presumably received little or no mercury because thimerosal was largely removed from childhood shots.

But California is an "ecological study" with problems of its own.

"Although (this) information is often used by media and research entities to develop statistics and draw conclusions, some of these findings may misrepresent the quarterly figures," cautions the website of the California Department of Developmental Services (DDS). "Increases in the number of persons reported from one quarter to the next do not necessarily represent persons who are new to the DDS system."

Even the CDC admits that "there are several limitations" with linking a VSD study design with the California data, Gerberding wrote to Congress, because, among other things, California only counts "persons who were referred to and/or voluntarily entered" the disability system."

It will be interesting to see how the House Committee -- and the mainstream media -- react to this rather breathtaking confession by the CDC, which does seem to want to conduct the best vaccine-autism science possible (see Gerberding's replies to NIEHS recommendations for improving the VSD: CDC officials are currently conducting in- depth follow up studies with VSD patients).

As the waning months of the Bush administration get underway, I can't help but wonder if a little housecleaning might be going on at some of our top health agencies.

(And on that note, please see my blog about the upcoming HHS/FDA/CDC/NIH workshop on autism triggers in mitochondrial disorders (ie, Hannah Poling and her five vaccines).

Sunday, June 15, 2008

FDA issues precautionary note on silver fillings

FDA issues precautionary note on silver fillings

Jun 12, 11:37 PM (ET)

By LAURAN NEERGAARD

WASHINGTON (AP) - Silver dental fillings contain mercury, and the government for the first time is warning that they may pose a safety concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web site earlier this month, to settle a lawsuit - making the move a victory for anti-mercury activists.

The warning is not aimed at the general population, only at two groups already urged to limit mercury from another source - seafood - because too much can harm a developing brain.

The fillings, formally known as dental amalgams, "contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses," reads the FDA Web posting.

That doesn't mean it truly harms, and the FDA advises against removing existing fillings.

The agency still is studying whether the small amount of mercury vapor released by chewing and brushing is enough to cause neurologic disorders or other problems in youngsters. There have been only a handful of rigorous studies comparing children given either amalgam fillings or tooth-colored resin composite fillings that are mercury-free - and those studies haven't detected any brain problems.

Nor has that research settled the long-simmering scientific controversy. Two years ago, the FDA's own independent scientific advisers said that while amalgam fillings were safe for most people, more research was needed about potential effects on fetuses and children under 6.

And this spring, the FDA put dentists on notice that it is considering additional controls, including whether to require warnings that would advise consumers of the mercury in amalgams before they have a cavity filled, or perhaps even restrict use in small children and certain other patients. It is accepting public comments until July 28.

"It's an open question what we will do," FDA Deputy Commissioner Randall Lutter told The Associated Press. But, "what this says is there's a clear intent on our part on labeling for sensitive subpopulations."

Expect a final ruling by July 28, 2009, a date set by that legal settlement.

"It's a watershed moment," said Michael Bender of the Mercury Policy Project, who with other advocacy groups had sued the FDA in hopes of forcing restrictions on amalgams.

"This court settlement signals the death knell for mercury fillings," added Charles Brown, an attorney for Consumers for Dental Choice.

Not so fast, say dentists who point to medically crucial reasons to use amalgams - and worry that people who can't afford more expensive alternatives might avoid dental care.

"We don't want these choices taken away based on junk science. We don't want them taken away based on misguided fears," said Dr. Edmond Hewlett, a dental professor at the University of California , Los Angeles , and an American Dental Association adviser.

Amalgam fillings are about 50 percent mercury, joined with silver, copper and tin. The hardened mixture makes the mercury less absorbable by the body than the kind found in fish, said Hewlett, who chose an amalgam filling for his own 7-year-old son.

Used since the 1800s, amalgams' popularity already is dropping. They account for about 30 percent of U.S. fillings, still millions of people a year.

They're cheaper than alternatives - roughly $100 for an amalgam filling versus $150 or more for a composite, Hewlett estimates - and they're known as particularly durable. Hewlett said two conditions that demand amalgams: Spots on back teeth that dentists can't keep dry long enough for a composite filling to bond, and in people who forcefully grind their teeth.

Science operates on "a precautionary principle," said Dr. Karl Kieburtz, a University of Rochester neurologist who co-chaired the 2006 FDA advisory committee and praised the new warning.

"For 99 percent-plus of people, there probably isn't harm. But if there is a group of people who might be at risk, they should at least have the knowledge that may be so," he said.

Several other countries limit amalgams, either as a precaution in pregnant women and small children or because of environmental concern. Dental workers make amalgam fillings by mixing liquid mercury with powdered ingredients, requiring special safety steps and filters to limit waste seeping back into the environment.

Monday, June 9, 2008

OP/Ed from Vindy.com

People step up to wage vaccine fight while media watches and doctors look the other way

Published:Sunday, June 8, 2008

EDITOR:

On Wednesday we attended a rally in Washington, D.C., headed by celebrities Jenny McCarthy and Jim Carrey urging the government and the vaccine industry to “green our vaccines.” Most people aren’t aware that vaccines contain various toxic ingredients — aluminum, formaldehyde, ether, and some still contain mercury, contrary to what you may have heard. It should be more then obvious to anyone (that is unless you work at the CDC) that toxins have no place in things we inject into our babies. Besides requesting a “greening of vaccines” Jim and Jenny’s message was simple, “Too many, Too soon”.

Reflect on this for a moment: Autism was 1 in 10,000 in 1983; it’s 1 in 150 in 2008. In 1983 children received 10 vaccines before school age. Today, it is an astounding 36 doses of various vaccines in the same time frame. Autism rates have risen simultaneously as the vaccine schedule has grown.

Vaccines have never been tested in combination. Some children are given an alarming eight shots at one time. Babies should never be vaccinated while they are sick — an all-too-common practice which has led many parents to report their child never being the same again after receiving shots while ill. The CDC provides a recommended list of vaccines, not a mandatory list. It is imperative that parents’ educate themselves on what exactly the diseases are that are being “recommended” for their child to be vaccinated against. Parents need to start making fully informed decisions when it comes to vaccines. The American Academy of Pediatrics has done nothing to address the autism epidemic. It’s done nothing to quell growing parental fears of what makes a child suddenly become autistic after receiving multiple vaccines. The AAP along with the CDC declined invitations to address the concerns of rally goers. Frankly, our community has lost faith in them. Over 8, 000 people attended the rally to lend a voice over concerns of toxins in vaccines. Every state in the union was represented along with Canada, Mexico, and the Philippines. What was so very disappointing was the poor media coverage this rally received by the mainstream media.

Our politicians need to be held accountable to us and our children. Any person holding office or running for public office should know our children are being damaged from toxic vaccines and they had better be willing to craft and support legislation that works to correct this problem and spare future generations from harm. In addition, they need to be prepared to create legislation that secures the funding needed to support the hordes of soon-to-be adults that will need lifelong care because they have been rendered autistic and unable to care for themselves. Robert Kennedy Jr. informed the crowd that the Iraq war is projected to cost us 3 trillion dollars. Yet, caring for all these autistic people will make that figure look small in comparison.

Our most precious commodity — our children — are literally being destroyed by government controlled propaganda and a profit driven medical establishment.

MATT and ANDREA KELLER

CANFIELD

Wednesday, June 4, 2008

Act Today to Stop Worst Vaccine Bill Ever in New York

Act Today to Stop Worst Vaccine Bill Ever in New York

ALL FEDERAL SHOTS WILL BECOME MANDATORY

Take action now to stop the worst state vaccine bill ever. Assembly Bill 10942 would make all vaccines recommended by the CDC mandatory for all children to attend school and, and for the first time vaccines would become mandatory for infants and toddlers.

Click on the Link below and use our email tool to contact your Assemblymember and your State Senator.

http://capwiz. com/a-champ/ issues/alert/ ?alertid= 11428606&type=ML

The bill was introduced in Rules Committee at the request of Richard Daines, the Commissioner of the New York State Department of Health. The Rules Committee in the personal committee of the Assembly Speaker Sheldon Silver (D-Manhattan) .

A-CHAMP is calling for rejection of this bill and is demanding the passage of A5468/S3031, a bill that would give individuals a right to a philosophical exemption from vaccine mandates. This is no time to transfer vaccine decisions away from individuals and elected officials answerable to the voters and give it to obscure bureaucrats with financial ties to the vaccine industry.

Here are just a few features of the proposed bill:
Our elected New York representatives would no longer determine the mandatory schedule of vaccines to attend school; decisions made by the federal Advisory Committee on Immunization Practices would automatically become mandatory.

All children, infants and toddlers included, in New York would be required to get all vaccines recommended by the ACIP according to the ACIP schedule
Religious exemptions may not apply to children younger than school age
All children in New York up to age 18 would be required to get annual flu shots.

All girls in New York would be required to get a human papilloma virus shot.
All junior high school children and college students would be required to get meningococcal shots.

Doctors would be required to issue certificates for every shot given and parents would be required to maintain the records and provide them to school and other authorities.

The rules committee claims that the new laws would have no fiscal impact on the state despite the necessity of the state to spend tens of millions on purchasing new vaccines, a vast increase in mandatory record keeping and enforcement for schools, and a huge increase that could be expected in the number of cases of neurological damage, Guillian Barré syndrome and other vaccine-caused injuries.
We only have a few weeks to defeat this bill. Let your Assemblymember and State Senator know immediately that a vote for this bill guarantees that you will do everything you can to get them un-elected.

Click on the link to find out who your representatives are and send them a message. And forward this at any friends or family or anyone else who would support protecting our rights and children.

http://capwiz. com/a-champ/ issues/alert/ ?alertid= 11428606&type=ML

Wednesday, April 30, 2008

United Methodist Church Passes Resolution Against Mercury In Medicine

United Methodist Church Passes Resolution Against Mercury In Medicine More Info

In A First – Faith Community Takes Historic Position Opposing Mercury in Medicines & Vaccines

United Methodist Church Passes Resolution
Against Mercury in Medicine
Press Release Contacts:
For Immediate Release CoMeD President [The Rev. Lisa K. Sykes (Richmond, VA) 804-364-8426]
April 29, 2008 CoMeD Sci. Advisor [Dr. Paul G. King (Lake Hiawatha, NJ) 973-263-4843]

With passage of a historic resolution today at its 2008 General Conference, the United Methodist Church has become the first faith community to officially oppose the use of mercury, in any form, including Thimerosal, in medicines, especially vaccines.

Beginning in 2005, several United Methodist Annual Conferences and its Women's Division, an organization of nearly 1 million women globally, passed a resolution entitled, "Protecting Children from Mercury-containing Drugs." Today, the validity of this urgent issue was further affirmed by the General Conference of the United Methodist Church, which speaks authoritatively for the denomination' s 11.5 million members worldwide.

This faith-based resolution, passed April 29, 2008, is a challenge to the current acceptance of mercury in medicine by the U.S. Government, the American Medical Association, the American Academy of Pediatrics, and the vaccine manufacturers.

Among its provisions, the resolution seeks: the immediate prioritization of mercury-free vaccines and other drugs for vulnerable children and pregnant women, the opportunity of informed consent whenever mercury is administered as part of a pharmaceutical product, and a ban of mercury-containing drugs. The complete text and details of the resolution's passage may be found at http://calms. umc.org/2008/ Menu.aspx? type=Petition&mode=Single&number=409

In addition, the resolution calls for United Methodist hospitals, clinics, and missions around the world to express a preference for mercury-free vaccines and other medicines. This is crucial because most of the Thimerosal-containi ng vaccines sent to the developing world still contain unreduced levels of mercury, as do most flu shots, and some other vaccines and drugs in the United States.

The Rev. Lisa K. Sykes, President of CoMeD, Inc, mother of a mercury-toxic child and a United Methodist clergywoman who has helped to shepherd this activist movement within The United Methodist Church, declared:

"This is the start of a Second Great Temperance Movement. More than a hundred years ago, our church fought widespread alcohol intoxication. With this resolution, we begin to fight widespread and, until now, unrecognized mercury intoxication from unsafe mercury-containing medicines."

CoMeD, Inc. is a not-for-profit 501(c)(3) corporation actively engaged in legal, educational and scientific efforts to stop all use of mercury in medicine, and to ban the use of all existing in-date mercury-containing medicines. To support CoMeD's efforts financially, please use the PayPal link on CoMeD's website, http://www.mercury- freedrugs. org , for your tax-deductible

Saturday, April 26, 2008

Autism Risk Linked To Distance From Power Plants, Other Mercury-releasing Sources

Web address:
http://www.sciencedaily.com/releases/2008/04/
080424120953.htm

Autism Risk Linked To Distance From Power Plants, Other Mercury-releasing Sources

enlarge

Is the risk of autism greater for children who live closer to the pollution source? (Credit: iStockphoto/Marcin Pawinski)

ScienceDaily (Apr. 25, 2008) — How do mercury emissions affect pregnant mothers, the unborn and toddlers? Do the level of emissions impact autism rates? Does it matter whether a mercury-emitting source is 10 miles away from families versus 20 miles? Is the risk of autism greater for children who live closer to the pollution source?

A newly published study of Texas school district data and industrial mercury-release data, conducted by researchers at The University of Texas Health Science Center at San Antonio, indeed shows a statistically significant link between pounds of industrial release of mercury and increased autism rates. It also shows—for the first time in scientific literature—a statistically significant association between autism risk and distance from the mercury source.

“This is not a definitive study, but just one more that furthers the association between environmental mercury and autism,” said lead author Raymond F. Palmer, Ph.D., associate professor of family and community medicine at the UT Health Science Center San Antonio. The article is in the journal Health & Place.

Dr. Palmer, Stephen Blanchard, Ph.D., of Our Lady of the Lake University in San Antonio and Robert Wood of the UT Health Science Center found that community autism prevalence is reduced by 1 percent to 2 percent with each 10 miles of distance from the pollution source.

“This study was not designed to understand which individuals in the population are at risk due to mercury exposure,” Dr. Palmer said. “However, it does suggest generally that there is greater autism risk closer to the polluting source.”

The study should encourage further investigations designed to determine the multiple routes of mercury exposure. “The effects of persistent, low-dose exposure to mercury pollution, in addition to fish consumption, deserve attention,” Dr. Palmer said. “Ultimately, we will want to know who in the general population is at greatest risk based on genetic susceptibilities such as subtle deficits in the ability to detoxify heavy metals.”

The new study findings are consistent with a host of other studies that confirm higher amounts of mercury in plants, animals and humans the closer they are to the pollution source. The price on children may be the highest.

“We suspect low-dose exposures to various environmental toxicants, including mercury, that occur during critical windows of neural development among genetically susceptible children may increase the risk for developmental disorders such as autism,” the authors wrote.

Study highlights

  • Mercury-release data examined were from 39 coal-fired power plants and 56 industrial facilities in Texas.
  • Autism rates examined were from 1,040 Texas school districts.
  • For every 1,000 pounds of mercury released by all industrial sources in Texas into the environment in 1998, there was a corresponding 2.6 percent increase in autism rates in the Texas school districts in 2002.
  • For every 1,000 pounds of mercury released by Texas power plants in 1998, there was a corresponding 3.7 percent increase in autism rates in Texas school districts in 2002.
  • Autism prevalence diminished 1 percent to 2 percent for every 10 miles from the source.
  • Mercury exposure through fish consumption is well documented, but very little is known about exposure routes through air and ground water.
  • There is evidence that children and other developing organisms are more susceptible to neurobiological effects of mercury.

Implications

“We need to be concerned about global mercury emissions since a substantial proportion of mercury releases are spread around the world by long-range air and ocean currents,” Dr. Palmer said. “Steps for controlling and eliminating mercury pollution on a worldwide basis may be advantageous. This entails greener, non-mercury-polluting technologies.”

The U.S. Environmental Protection Agency (EPA) estimated environmental mercury releases at 158 million tons annually nationwide in the late 1990s, the time period studied by the Texas team. Most exposures were said to come from coal-fired utility plants (33 percent of exposures), municipal/medical waste incinerators (29 percent) and commercial/industrial boilers (18 percent). Cement plants also release mercury.

With the enactment of clean air legislation and other measures, mercury deposition into the environment is decreasing slightly.

Limitations

Dr. Palmer and his colleagues pointed out the study did not reflect the true community prevalence rates of autism because children younger than school age are not counted in the Texas Education Agency data system. The 1:500 autism rates in the study are lower than the 1:150 autism rates in recent reports of the U.S. Centers for Disease Control and Prevention.

Furthermore, the authors note that distance was not calculated from individual homes to the pollution source but from central points in school districts that varied widely in area.

Data sources

Data for environmentally released mercury were from the United States Environmental Protection Agency Toxics Release Inventory. Data for releases by coal-fired power plants came from the same inventory and from the Texas Commission for Environmental Quality. Data for school district autism came from the Texas Education Agency.

Journal reference: Palmer, R.F., et al., Proximity to point sources of environmental mercury release as a predictor of autism prevalence. Health & Place (2008), doi:10.1016/j.healthplace.2008.02.001.

Adapted from materials provided by University of Texas Health Science Center at San Antonio.

Friday, April 18, 2008

Robert F. Kennedy Jr. Interview with Spectrum Magazine

His crusade continues.

By Sarah Bridges, Ph.D. / Photos by Robert Milazzo

Robert F. Kennedy Jr.’s watershed moment occurred in 2006 when he visited the New York Times headquarters to discuss an editorial piece he submitted on the link between vaccines and neurological disorders in children. Ushered into a small room for what was set to be a private meeting with an editor, he instead found the space crammed with people, overflowing onto the arms of old leather chairs, with expressions ranging from boredom to disdain. Image
“I expected a discussion with the editor of the Times, but when I went in to meet, they had assembled a group of science editors that were so hostile and antagonistic, it was like talking to a brick wall,” Kennedy remembered. “They were absolutely determined that there would be no public discussion in their paper about mercury and neurological disorders.” His sentences were cut short by rapid retorts, as if the room was laced with invisible mines. Despite Kennedy’s information, and the phonebook-sized stack of articles that Dr. Boyd Haley had perched on his lap ready to share, the editors quickly shut down any discussion of thimerosal’s dangers; one person near the door sighed and rolled his eyes. The meeting progressed for 30 minutes, Kennedy offering DNA, animal, genetic, epidemiological and biology studies, and being met repeatedly with the statement, “The CDC says the vaccines are safe.”

To read more click here.

Anne Dachel - NY Times Saga

When I first compared the original April 11 AP story, "Gov't Seeks Help With Vaccine Questions," http://ap.google.com/article/ALeqM5gQkR4fS0l1M7ouxFGOr6WtrJpkPQD8VVVRTO0

with the version that the NEW YORK TIMES put out on April 13, titled, "Vaccine Safety Panel to Include the Public in Setting Priorities," I was stunned by their selective omission of any of the really glaring statements on vaccine damage. http://www.nytimes.com/2008/04/13/washington/13vaccine.html?_r=2&ref=us&oref=slogin&oref=slogin The intent was obvious: soften the evidence that points to vaccines as the cause of autism.

Then someone sent me the Spectrum piece about RFK Jr's efforts to get the TIMES to legitimately report on the evidence out there. I saw immediately that it backed up everything I felt about how the TIMES covers autism. What really got my attention in the Spectrum story was the mention that Dr. Boyd Haley, an outstanding authority on mercury toxicity, was at the meeting with the TIMES editors and that he came with a stack of scientific material to support his claims. The Spectrum article said,

Despite Kennedy's information, and the phonebook-sized stack of articles that Dr. Boyd Haley had perched on his lap ready to share, the editors quickly shut down any discussion of thimerosal's dangers; one person near the door sighed and rolled his eyes. The meeting progressed for 30 minutes, Kennedy offering DNA, animal, genetic, epidemiological and biology studies, and being met repeatedly with the statement, "The CDC says the vaccines are safe."

Case closed.

The facts don't seem to matter at the TIMES. The damage being done to a generation of children isn't their concern either. Supporting the make-believe science coming out of the CDC is all they care about.

I asked Dr. Haley about the accuracy of the account of the TIMES meeting with Robert Kennedy. This is what he wrote back and is allowing me to share:

Robert Kennedy asked me to accompany him to the Times and the description in this article is very close to how I remember the meeting. The writers were not at all interested in the published science. I would make a comment about thimerosal toxicity . . . and they would look surprised---but they never asked for any of the stack of reports to verify what I said. Afterwards, one of the writers, a young man, whose name I don't remember, followed me out the door and downstairs seemed interested and asked some detailed questions, but later wrote an article and did not mention any of the published science about the toxicity of thimerosal. I lost a lot of respect for the New York Times that day and felt quite sorry for Robert Kennedy who was just asking for a logical look at the autism/vaccine issue. The Times did the opposite and wrote totally supporting the CDC line that their experts had eliminated vaccines as being involved.

Boyd Haley

And here is what I wrote about the NYTIMES and autism. I sent it separately to six email addresses at the Times. I included one to NYT reporter Gardiner Harris, long known for biased coverage on autism, since I mention him specifically. Maybe the NYT doesn't care about their reputation for junk autism coverage. They should. This is a disgrace for any newspaper, especially one with the credentials of the NYT. We're talking about children as victims in a health care disaster. The New York Times has failed our children and we aren't going to forget it.

AUTISM COVERAGE AT THE NYT: SINS OF OMISSION

Hostile_crowd_2BY ANNE DACHEL


Tuesday, April 15, 2008

Govt. Reaches Out To Vaccine Critics

WASHINGTON -- The government began an unprecedented effort Friday to give vaccine critics a say in shaping how the nation researches safety questions surrounding immunizations.
The meeting, the first in a planned series, came amid new controversy about vaccines and autism -- and a fledgling theory that vaccinations might worsen a rare condition called mitochondrial dysfunction that in turn triggers certain forms of autism.

Federal health officials said the work, being planned for two years, wasn't in response to that controversy, and encompasses many more questions than autism -- from rare side effects of the new shingles vaccine to how to predict who's at risk for encephalopathy sometimes triggered by other inoculations.

To read more, please click here.

Saturday, April 12, 2008

Will a 9 year old change the vaccine debate?

April 12, 2008, 4:39 pm
Will a 9-Year-Old Change the Vaccine Debate?

Hannah Poling (W.A.Harewood/Associated Press)

There’s no question that the case of 9-year-old Hannah Poling of Athens, Ga., has fueled the controversy about childhood vaccines. But what’s less clear is whether it will help unlock the mysteries of autism.

Hannah was 19 months old and developing normally until 2000, when she received five shots against nine infectious diseases. She became sick and later was given a diagnosis of autism.
Late last year government lawyers agreed to compensate the Poling family on the theory that vaccines may have aggravated an underlying disorder affecting her mitochondria, the energy centers of cells. (To read more about the decision, click here.) Vaccine critics say the Hannah Poling settlement shows the government has finally conceded that vaccines cause autism. But government officials say Hannah’s case involved a rare medical condition, and there is still no evidence of a link between vaccines and autism.

Hannah’s father, Dr. Jon S. Poling, a practicing neurologist in Athens and clinical assistant professor at the Medical College of Georgia, says the case has shifted the autism debate forever and points to a promising new area of research.

Writing in The Atlanta Journal-Constitution on Friday, Dr. Poling says there is compelling evidence that mitochondrial disorders, like the one his daughter has, are strongly associated with autism.

To understand Hannah’s case, it is important to understand mitochondria, which act like batteries in our cells to produce energy critical for normal function…. Emerging evidence suggests that mitochondrial dysfunction may not be rare at all among children with autism. In the only population-based study of its kind, Portuguese researchers confirmed that at least 7.2 percent, and perhaps as many as 20 percent, of autistic children exhibit mitochondrial dysfunction. While we do not yet know a precise U.S. rate, 7.2 percent to 20 percent of children does not qualify as “rare.” In fact, mitochondrial dysfunction may be the most common medical condition associated with autism.

Dr. Poling urges the Institute of Medicine and public health officials to pursue research into mitochondrial conditions, which he describes as a “breakthrough in the science of autism.'’ He writes: National public health leaders, including those at CDC, must now recognize the paradigm shift caused by this biological marker with regard to their current position of dispelling a vaccine-autism link. In light of the Hannah Poling concession, science must determine more precisely how large the mitochondrial autism subpopulation is: 1 percent, 7.2 percent, 20 percent?

To be sure, many health experts do not agree with Dr. Poling’s conclusions. The case has “added nothing to the discussions of what causes or doesn’t cause autism,” said Dr. Edwin Trevathan, director of the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention.

On Friday, many of the main players involved in this debate — including Hannah’s mother and her grandparents, prominent vaccine skeptics and some of the government’s top vaccine researchers — took part in the federal government’s first-ever public meeting to discuss a government-wide research agenda to explore the safety of vaccines.

To read Dr. Poling’s complete essay, click here. Last month, Dr. Paul A. Offit, chief of the infectious diseases division of the Children’s Hospital of Philadelphia, explained his view that the Hannah Poling case has been mischaracterized by vaccine critics. To read the piece, click here. Hannah Poling’s parents wrote this response to Dr. Offit’s report. Last month, The Atlanta Journal-Constitution wrote this profile of Hannah and her parents.

Sunday, April 6, 2008

Autism Yesterday Premier - Press Release

FOR IMMEDIATE RELEASE

Biomedical Intervention Group of OKC/Edmond

Contact Information - Bigofokc@yahoo.com

405-488-7609, 405-306-9184, 405-204-1713

IS AUTISM TREATABLE AND EVEN REVERSIBLE?

Join the Biomedical Intervention Group of Oklahoma City/Edmond and Aaron’s Bridge (www.aaronsbridge.org) for the world wide premiere of the documentary, “Autism Yesterday”. Oklahoma City will premiere this documentary along with over 100 other venues across the world simultaneously on Thursday, April 17th, 2008 at 7:00 p.m. The Oklahoma premiere will be shown at the Oklahoma City Metropolitan Library Downtown Location, 300 Park Avenue, Oklahoma City, 73102 (on the corner of Hudson and Park Avenue). The event will be in 46th Star Auditorium located on the 4th floor of the library. Admission is free and garage parking is available South of library at the cost of $3.00 for 2 hour parking.

The documentary was created by Generation Rescue (www.generationrescue.org) and follows the lives of five families on their journey to heal their children from a disorder that had been previously deemed a life long condition. In the film you will see the progress and recovery of the children using biomedical treatment as only families living through it can tell. A parent/doctor panel discussion will follow the film. The featured doctor will be Neurodevelopmental Pediatrician, Dr. D.L. Gheen of Edmond. The parent panel will consist of experienced parents who are successfully treating their children with biomedical treatments.

David Kirby, best selling author of ‘Evidence of Harm” reviews the film and writes, “In each story, we see clear before-and-after evidence of a child’s heartbreaking descent into the silent, baffling world of autism, and then their steady, sometimes miraculous progress back towards health, happiness, communication and, yes, recovery. The film, in elegant detail, shows us exactly how far these kids have come. A trailer may be viewed at http://www.autismyesterday.com/trailer.html.

The primary goal of this event is to present hope. Many families are not given hope and are told that “autism is not treatable”. Biomedical Intervention Group of OKC/Edmond and Aaron’s Bridge were founded by local parents that have witnessed their children become healthier with consistent biomedical treatment supervised by well-trained physicians. Their belief is based on new research that autism is a medical condition and that over time “autistic” symptoms can be reduced and sometimes alleviated with consistent biomedical treatment. Currently, Oklahoma has a shortage of physicians specializing in the biomedical treatment of this neurobiological disorder. The hope is that additional Oklahoma medical professionals will become specialized to treat more Oklahoma children with autism spectrum disorders. Currently, more children are diagnosed with autism than all types of childhood cancer, diabetes, and AIDS combined (Centers for Disease Control, 2007).

Byron Richards comments on Vaccines and Autism

hursday, April 3, 2008
Byron Richards, CCN
On April 2, 2008 CNN spent the day bringing awareness to the problem of autism. Larry King’s segment, which included Jenny McCarthy along with a panel of guests, was particularly enlightening. My hat is off to Jenny, a celebrity mother who is making it quite uncomfortable for the Center for Disease Control (CDC) to ignore parents of autistic children seeking answers.

Why does a mom have to do the work of the CDC? The answer is rather simple: our government’s zeal to insist on too many vaccines while ignoring the actual risks is the driving force behind the autism tragedy. Sure there are many related factors – but the bottom line is that our government is causing disease at an alarming and devastating pace.

It is an interesting comment on our society that an outspoken and impassioned mother of an autistic child, along with her partner (actor Jim Carrey), are the catalysts that are likely to cause a warped empire to crumble. Many before them have tried; and typically been burned at the stake. Jenny and Jim are the government’s worst nightmare. They can’t shut down their medical practice because they don’t have one. They can’t financially damage them into silence. And as they lead their autism March on Washington D.C. this June 4th it is quite clear that they haven’t a prayer of shutting them up. A powder keg is about to blow.

Read more

Reform the childhood vaccination schedule

Published on SavannahNow.com (http://savannahnow.com)

Saturday, April 5, 2008 at 11:30 pm

Columnist Anne Hart writes it's time to take a hard look at the aggressive schedule on which immunizations are given.

Mention the possibility of a link between autism and vaccines to a mainstream doctor and expect some eye rolls. Or ridicule. Or, in some cases, downright contempt.

The mainstream medical establishment continuously rejects any correlation between childhood vaccinations and autism, a disorder that affects one in 150 children in the United States.
But that rejection isn't silencing valiant and vocal parents pushing for safer vaccines and a less aggressive immunization schedule after their children were diagnosed with autism.

To read more please click this link.

Friday, April 4, 2008

David Kirby - CDC Has Lost Control of the Autism Argument

Posted April 4, 2008

On Wednesday, CNN's Larry King hosted Jenny McCarthy, myself, and several others to discuss the growing evidence of a link between childhood vaccines and autism. The CDC refused to send someone to appear on the show. Instead, on Thursday, the agency issued a statement meant to reassure the American public that all vaccines are safe for all kids.

To read the rest of the article, please click here.

KOCO Vaccine TV Interview of SB 1407

Click Here to view the video on SB 1407 by Sen Gumm

Autism's simmering controversy - Louisville Courier

Area parents debate possible link to vaccinations

By Laura Ungarlungar@courier-journal.com • March 31, 2008

As a baby, Austin Pope seemed to be developing normally -- even at an advanced pace, saying 75 words at 18 months.

But a month after getting five vaccines in one day, an unusually high number at the time, Austin began regressing, said his mother, Janet Pope of Crestwood.

One morning, he woke up with a stiff neck and just flopped in her arms. Ultimately, he stopped talking, stopped making eye contact and retreated into the world of autism.

Pope, whose son is now 16, tells a common story, one she compares to a recent case that spotlights a long-simmering controversy about a possible link between childhood vaccinations and autism that has been rejected by the mainstream medical establishment.

This month, federal officials conceded that 9-year-old Hannah Poling of Athens, Ga., should be awarded damages from a federal vaccine-injury fund because vaccines worsened a rare mitochondrial dysfunction, a problem involving cell metabolism. This, they said, led to autism-like symptoms.

"I'm hoping this will break the issue wide open," said Pope, 52, a former emergency room nurse and Air Force major.

Boyd Haley, a University of Kentucky chemistry and biochemistry professor who was an expert witness in support of the Poling case, argues that the vaccine preservative thimerosal, which contains mercury, can cause autism and mitochondrial dysfunction.

"This young girl probably didn't have a disorder until'' she was exposed to thimerosal, Haley said.

To read more about this article, click here.

CDC Under Siege - Deirdre Imus

When American scholar Warren Bennis said, "Bureaucracies are beautiful mechanisms for the evasion of responsibilities and guilt," he might well have been speaking of the current state of affairs inside the Centers for Disease Control and Prevention (CDC).

Once revered around the world, hardly a month passes without another news report questioning the credibility, scientific independence, and integrity of the nation's premier health agency.

Over the past four years headlines frequently chronicle a disturbing litany of allegations charging top CDC officials with wasting money on questionable research priorities, public relations stunts, distorting or ignoring health concerns raised by their own scientists, and retaliation against those who object to the censorship of scientific findings.

The past three years have been particularly unpleasant for CDC Director, Dr. Julie Gerberding, but apparently not as bad as she and her managers are making it for many CDC scientists.

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Research supports mercury-autism link Denver Post





Written by Michael Wagnitz
Thursday, 03 April 2008

It was reported repeatedly in 2006 that the link between mercury-containing vaccines and autism has been disproven. Yet if one looks at the most recent research coming from some of our major universities, one may draw the opposite conclusion.

What we have learned in the last couple of years is that the underlying medical condition of autism is neuroinflammatory disease. In a study conducted at John Hopkins University, brain tissue from deceased autistic patients was examined. The tissue showed an active neuroinflammatory process and marked activation of microglia cells. Neuroinflammatory disease is synonymous with an activation of microglia cells.

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Wednesday, April 2, 2008

Vaccine-autism question divides parents, scientists

CNN story - Dr. Boyd Haley's response to the CNN story

Click Here to watch the video.

FROM DR. BOYD HALEY:

To all: This represents the major problem parents of autistic children face in getting national public support. The very idea that “it is a parent versus science” debate. It isn’t-- all of the well done biological science supports an oxidative stress based illness and nothing reduces reduced glutathione better than mercury or organic mercury compounds. What else toxic is the autistic infant exposed to? The work by Holmes, Bradstreet, Hornig, Deth, Haley, Nataf, James, Lathe, etc. support the concept that a toxin has injured these children that is mercury based. Yet this science is never presented or discussed by the mass media---instead it is always a well educated CDC physician versus an emotional mother of an autistic child that seems to be highlighted. Sometimes, it is a single courageous physician (usually also the parent of an autistic child) presenting the argument. Nothing wrong with this, except it totally excludes the very hard fact that thimerosal has been proven to be one of the most toxic and, specifically neurotoxic, of compounds AND the biological systems affected in autistic children are those that are mercury sensitive.

Let’s see how many of the above listed researchers are interviewed in the CNN presentation on the “mystery of autism causation”. I will bet the farm that most of the research discussed will be the famous 5 epidemiological studies, paid for by the CDC, and done totally by foreigners who all now live in Europe and work for vaccine manufacturers. Also, 4 of these studies were done on foreign data bases and the “Danish studies done by Hviid” were done, according to their own published data, on a data base with less than 5 autistics per 10,000 while the rate in the USA was 67 per 10,000.

When will the mass media experts as the tough questions? Why hasn’t a premier USA university been commissioned to evaluate the possible causation between vaccine exposure and autism? Given the Amish report by Dan Olmstead this should have been done long ago. The rate of autism in the non-vaccinated population is where the answer to this question lies---and I am sincerely of the opinion that the CDC already knows the answer to this question. Let’s see if the study from the Medical Center in Mannitoba, Canada that showed an asthma rate of about 16% versus 5% on children vaccinated at 2 months versus 4 months of age will be discussed. It clearly shows a relationship between age of vaccination and an illness that has increased like autism.

This morning on CNN Dr. Gupta presented a piece on the observation of autism like symptoms in pre-term babies. I was shocked as I have talked to parents of autistic children who were born premature who were vaccinated on the day of birth even though these children are medically compromised. Go figure. In my opinion, our vaccine program is in the hands of incompetent individuals and Dr. Paul Offit proves this every time he speaks.

Boyd Haley