US Congress: "Under the Influence" of Big Pharma

"In all, at least 15 congressional staffers, congressmen and federal officials left to go to work for the pharmaceutical industry, whose profits were increased by several billion dollars. "I mean, they - they have unlimited resources. Unlimited," [Congressman] Burton says. "And when they push real hard to get something accomplished in the Congress of the United States, they can get it done." In January, one of the first things the new Democratic House of Representatives did was to make it mandatory for Medicare to negotiate lower prices with the drug companies. But a similar measure was blocked in the Senate, due in part to the efforts of the drug lobby." - Steve Kroft, "60 Minutes," CBS News , July 29, 2007

Barbara Loe Fisher Commentary:

This past Sunday, CBS's "60 Minutes" took on the pharmaceutical industry in a tough and well researched investigative report ("Under the Influence") on the strong-arm lobbying tactics of drug companies, who bully elected officials into passing legislation that guarantees drug companies higher profits. This report is an excellent example of what responsible journalists can do to inform the American people about how they are being exploited by big corporations and former "public servants" turned drug company lobbyists, who come back to Congress to twist the arms of their old colleagues. It was painful to watch this shocking report - congratulations to CBS for having the courage to produce and air it - and it is worth reading the transcript at www.cbsnews.com and letting CBS know you care about seeing more investigative journalism like this.

The pharmaceutical industry is twisting arms at the state level, too, to secure guaranteed windfall profits for pharmaceutical products. The most recent example is the aggressive lobbying campaign by Merck to get its new HPV vaccine - GARDASIL - mandated in every state. They failed to do that this year because there was a big parent backlash based on product safety and parental rights concerns and state legislators heard the public's message loud and clear: no HPV vaccine mandates for 11 year old girls.

However, the drug company lobbyists are working hard to get GARDASIL mandated in California after all. To guarantee that the people never again have the opportunity to stop drug companies like Merck from guaranteeing that their new vaccines will be mandated, Pharma lobbyists have persuaded California Rep. Ed Hernandez and others to introduce a law (AB 16) that would cut the voters and the state legislature out of having any say whatsoever in future new vaccine mandates. Cleverly, what vaccine manufacturers want to do is get a law passed in every state that leaves only one person - the State Health Officer - with the power to mandate new vaccines whenever the CDC recommends a new vaccine for universal use.

It is much cheaper to strong arm one federal vaccine policymaking committee - the CDC's Advisory Committee on Immunization Practices - and one state official in a state public health bureaucracy than to have to lobby hundreds of politicians in 50 state legislatures to convince them to mandate a new vaccine. Streamlining the U.S. vaccine mandating process would cut Pharma's lobbying costs so windfall profits from vaccine sales in the U.S. can be even larger - a projected $6.9B in 2007 - the highest for any country in the world. The power of the people would be totally removed from the vaccine mandating process and drug company lobbyists could concentrate all their efforts on strong-arming politicians in Congress to create more prescription drug profit-making schemes like the one CBS "60 Minutes" just highlighted.

The National Vaccine Information Center has been calling for reform of the mass vaccination system for 25 years. There have been too many instances in the past where former government health agency employees, who develop, regulate or promote mass use of multiple vaccines, have left their government jobs to work for vaccine manufacturers. The first step is to prohibit elected officials or staff or government health agency employees, who regulate or make recommendations for use of products sold by the pharmaceutical industry, from being employed by that industry for at least ten years following their government employment.

Government employees and elected officials responsible for ensuring the public health and safety should understand that when they join government, they are choosing to become public servants and that the corporate world is not accessible to them for at least a decade. This would prevent the revolving door that contributes to the kind of shameless exploitation of the people which CBS illustrated so well in their July 29 report "Under the Influence."

Mass Vaccination: Mother Nature Fights Back

"Outbreaks of mumps in the Midwest -- where more than 1,000 cases were reported by April 2006 among largely vaccinated teens and young adults -- fueled concerns about the long-term effectiveness of the immunization that was supposed to forestall such a scenario. "The only people who don't have to worry about the mumps in the Midwest outbreak, which is occurring primarily among college students who have two doses of MMR (measles-mumps-rubella) vaccine, are older Americans who recovered from mumps as children," Barbara Loe Fisher, co-founder and president of the country's largest and oldest vaccine safety and consumer watchdog organization, the National Vaccine Information Center, wrote in her newsletter. "Vaccines provide temporary, qualitatively inferior immunity compared to the qualitatively superior immunity achieved by recovering from the disease, which in most cases is permanent for once routine childhood diseases such as mumps.

".... the addition of a vaccine against pneumococcal disease -- including sepsis, or blood poisoning, meningitis, pneumonia and otitis media, or inflammation of the middle ear -- to the childhood immunization schedule, with four doses recommended in the first 18 months of life, has put a dent in the rate of sickness and of cases that fail to respond to treatment. At the same time, however, researchers have observed a dramatic shift in the microbial varieties that most often cause recurrent ear infections, the most common bacterial illness in young U.S. children. Since the Prevnar shot, formally known as conjugated heptavalent pneumococcal vaccine, or PCV7, was licensed in 2000, the bacteria it targets, Streptococcus pneumoniae, have taken a backseat to another type, Haemophilus influenzae. This flu bug now has become the predominant culprit in persistent ear infections as well, researchers reported in The Pediatric Infectious Disease Journal. Prior to the routine use of the vaccine and high-dose antibiotics, S. pneumoniae was implicated in nearly half of the cases, but now it is H. influenzae that brings on the malady 57 percent of the time, scientists said. " - Lydia Wasowitz, Earthtimes , Where Remedies Fall Short, July 23, 2007

Barbara Loe Fisher Commentary:

Time and again, when man attempts to alter the natural order, the change which occurs is damaging to the environment and the biological integrity of humans over the long term. Mandatory, mass vaccination policies have done far more than suppress or "eradicate" infectious diseases. Like the indiscriminate widespread use of multiple antibiotics, which has led to more virulent, antibiotic resistant bacteria, the indiscriminate widespread use of vaccines is placing pressure on viruses and bacteria to evolve and evade vaccines.

CDC officials direct pediatricians to give all infants 4 doses of pneumococcal vaccine in the first two years of life. Wyeth is the sole source of that vaccine (Prevnar) and heavily promoted it as an ear infection vaccine prior to its licensure in 2000, even though clinical studies demonstrated only a 6 percent efficacy for preventing ear infections. The vaccine contains seven of the most antibiotic resistant pneumococcal strains (there are more than 80 strains of the organism) and now, predictably, other strains of bacteria are replacing those contained in Prevnar vaccine and causing disease.

Some are also predicting this "replacement" effect will occur with the newly licensed HPV vaccine (Merck's GARDASIL), which the CDC has recommended be used by all 11 year old girls. GARDASIL contains two of the 15 strains of human papillamovirus that are associated with cervical cancer. However, FDA officials warned prior to the vaccine's licensure and CDC officials published an article in JAMA after licensure that widepsread use of GARDASIL could cause the two high risk HPV strains in the vaccine to be eventually replaced by other high risk strains.

When government officials and drug company lobbyists persuade politicians to pass laws mandating use of new vaccines, they often do not stop to consider the potential negative effects. The "cure" may be worse than the disease when public health officials and vaccine makers urge the public to use more and more vaccines and politicians are quick to legislate vaccine use without all of the scientific information required to make an intelligent decision on behalf of the people.

The study of wellness and finding more natural ways to help the body enhance immune function to both resist and recover from infectious disease so good health can be maintained over the long term might be a better way to go in the future, rather than placing narrow-minded emphasis on suppression and "eradication" of infectious disease with the mass use of multiple vaccines. If there is one thing that Mother Nature has demonstrated over the last century, it is that she is not amused when doctors and drug companies think they know how to do it better.

Vaccine Market To Hit $19.2B by 2010

"United States represents the largest market for human vaccines with sales estimated at US$6.9 billion for 2007. Within Europe, France, Germany, and United Kingdom together account for more than 3/4th of the market. In Japan, Pediatric prophylactic vaccines sales are likely to grow at a compounded annual rate of 9.9% over the period 2005-2010. Human vaccines market in Asia-Pacific is projected to reach US$1.3 billion by the year 2010. Most multinational companies engaged in vaccine production are based in the US and Europe.....Pediatric combination vaccines, another new entrant in the vaccines market are forecast to fuel growth in the coming years. The market is expected to witness new levels with adoption of novel vaccine delivery mechanisms such as edible, oral, and mucosal. Also critical to market success is the need for using improved adjuvants in vaccines for optimal immunogenicity.....Dominant players in the market comprise leading pharmaceutical companies including Sanofi-Aventis, GlaxoSmithKline, Wyeth, and Merck. These companies together command about 80% share of the global human vaccines market." - Global Industry Analysts, Inc.

Barbara Loe Fisher Commentary:

If anyone doubts why drug companies making and selling vaccines are lobbying so hard to convince California legislators to pass a precedent-setting law that would automatically mandate every new vaccine the CDC recommends for "universal use" by all children, the recent market analysis by Global Industry Analysts gives the answer: forcing vaccine use is a multi-billion dollar business. The U.S. is the largest market for human vaccines: vaccine manufacturers will rake in $6.9B in 2007. Much of the profit is guaranteed because the lobbying alliance between drug companies, public health officials and pediatricians that has formed during the past quarter century has worked hard to convince politicians to mandate the use of more vaccines by US citizens than are used by any other country in the world.

The freedom to exercise informed consent to vaccination and make informed voluntary vaccine choices in the US is being eroded by clueless legislators listening to profit-seeking drug companies and zealous government health officials in search of a 100 percent vaccination rate. No question that forced use of multiple vaccines makes for good profits. But where is the science that demonstrates it leads to good health?

The worldwide human vaccines market is projected to reach $19.2B and it is no surprise that "therapeutic" vaccines are projected to be the fastest growing segment with $3.3B projected sales by 2010 in the U.S. alone. The therapeutic vaccine market includes people suffering with chronic brain and immune system dysfunction, the very kinds of chronic diseases and disorders that can be caused by prophylactic vaccine use. In other words, those children who are harmed by forced prophylactic vaccine use will become consumers of therapeutic vaccines.

The price we will pay for having placed blind trust in physicians in industry and government, who are promoting mass, mandatory use of multiple vaccines, will be far higher in the future.

High Potency Polio Vaccine & India's Crippled Babies

"A two-year-old girl of this village, Saniya, suffers from Type I polio despite being administered more than seven doses of the new polio monovalent vaccine (MOPVI), which is made specially for the Type I poliovirus. The vaccine was introduced in mid-2005 and tom-tommed as the final step in the eradication of polio from India...... There are 15 cases of Type I polio spread across Uttar Pradesh (There are also 41 cases of Type II polio which takes the total count to 56). While there has been no reported Type I case in the endemic Moradabad, the new cases have been reported from eastern and central Uttar Pradesh; so instead of just a region, cases of wild polio are being reported from all over Uttar Pradesh now.

"Saniya's mother, Noorjahen, is furious. "She is having polio drops ever since she was four days old. She has had over a dozen doses of the polio drops. We came to know about her polio when she got a high fever. She could barely manage to stand, could not walk at all, after the fever. We took her to the local hospital where they did a stool test. We were later told that she has polio," she recounts. "There must be some thing wrong with the polio drops if even after so many doses my child has contracted polio. The government should test medicines before they are used. Pata nahin bachchoo ko kya pila rahin hain!" (Don't know what they are making my child drink), she adds.

"Head of the pediatrics department of Delhi- based St Stephen's Hospital, Jacob Puliyel, took up the matter with Lancet. In his strong-worded letter to Lancet's editor, he wrote: "We are shocked and dismayed that Lancet should have published the paper on the protective efficacy of monovalent oral Type I poliovirus...having overlooked the serious ethical issues involved." He went on to write, "What was introduced, according to this article, was a new vaccine that was five times more potent than previous vaccines, presumably also with the increased likelihood of adverse effects. No informed consent was taken, nor was the public told that the vaccine was experimental. Efforts were made to give the impression that the monovalent vaccine was not new." - Tehelka (New Delhi, India),UNTESTED VACCINE SURFACES IN POLIO OUTBREAK, July 28, 2007

Barbara Loe Fisher Commentary:

The wild-eyed vaccinologists are at it again. This time, World Health Organization doctors are hunting down children in India to pour a high potency live polio vaccine down their throats without telling parents it is an experimental vaccine. Using the unscientific rationale that "more is better" and with a callous disregard for human life and human rights, WHO officials replaced the tri-valent oral polio vaccine with an untested high potency monovalent Type 1 oral poliovirus vaccine without telling the public what it was doing.

Now there is more Type 1 (and Type 2) polio in India plus an unexplained higher incidence of non- polio Acute Flaccid Paralysis following widespread use of the experimental polio vaccine. Trotting out the shabby "coincidence" argument, the WHO's predictable response is "This is due to better reporting and surveillance. We know by our 50 years of experience that the polio vaccines are safe."

We have seen vaccinologists exercise unchecked power and experiment on children without the informed consent of their parents before and we will see it again. Exploitation is easy when people are carefully taught to trust and obey the orders of anyone wearing a white coat who comes to vaccinate.

The distraught mother of a little girl crippled by Type 1 polio after swallowing many doses of both the tri-valent and experimental mono-valent live polio vaccines was quoted by India's Tehelka (The People's Paper): "She is having polio drops ever since she was four days old. She has had over a dozen doses of the polio drops....There must be some thing wrong with the polio drops if even after so many doses my child has contracted polio. The government should test medicines before they are used. Pata nahin bachchoo ko kya pila rahin hain!" (Don't know what they are making my child drink), she adds."

One brave and clear thinking pediatrician in New Delhi, Jacob Puliyel, has written a letter to the editor of The Lancet, which published an article in April 2007 about the experimental high potency polio vaccine campaign in India. "We are shocked and dismayed that Lancet should have published the paper on the protective efficacy of monovalent oral Type 1 poliovirus....having overlooked the serious ethical issues involved...... What was introduced, according to this article, was a new vaccine that was five times more potent than previous vaccines, presumably also with the increased likelihood of adverse effects. No informed consent was taken, nor was the public told that the vaccine was experimental. " He protested experimentation on children by Indian health authorities, who licensed the experimental vaccine, and WHO authorities, who are running the mass vaccination program. "The oversight body that introduced this experimental vaccine should also have monitored adverse effects," he wrote to The Lancet. "Data from Uttar Pradesh show an increase in the incidence of non-polio Acute Flaccid Paralysis since the introduction of the monovalent vaccine."

Now that Dr. Puliyel, head of pediatrics at a New Delhi hospital, has spoken up about scientific and ethical lapses connected with the experimental polio vaccine program - will he be kicked out of his hospital and have his medical license revoked? Maybe not. But it is very likely that government health authorities and pediatrician colleagues will make his life miserable.

This kind of vaccine experimentation without informed consent does not happen only in India or Africa or South America among disadvantaged populations. This kind of exploitation also happens in America.

In what turned out to be a deadly experiment conducted during the mid-1980's using a high potency Edmonston Zagreb measles vaccine, vaccinologists first injected the experimental measles vaccine into four month old babies in Africa, the Middle East, Mexico and Haiti at 10 to 500 times the usual dose levels to try to overcome natural maternal antibodies and replace them with vaccine induced antibodies. Even though researchers in Africa knew half way through the experiment that a higher than expected number of girl babies were dying six months to three years following vaccination, the CDC moved the high potency measles vaccine trials to Los Angeles in 1990.

With the help of Kaiser Permanente, more than 1500 six month old primarily black and Hispanic babies in inner city LA were injected with the high potency EZ measles vaccine between June 1990 and October 1991. One child in the vaccine trial died from a bacterial infection that researchers insisted was unrelated to vaccination.

In June 1996, then CDC Director David Satcher admitted that an NIH investigation of the LA trial found that informed consent regulations had been violated: the LA parents were never told that their babies would be injected with an experimental vaccine that had never been licensed by the FDA for use in the U.S. Shortly after, researchers reported that infants with the highest antibody responses to high potency measles vaccine have the most profound immune suppression.

How high are the antibody responses of children in India who are repeatedly vaccinated for polio, especially after being given high potency polio vaccine? And how many are suffering immune suppression, which is followed by wild-type or vaccine strain polio or unexplained Acute Flaccid Paralysis?

The militaristic approach taken by vaccinologists employed by governments and the World Health Organization unfortunately includes conducting vaccine experiments without the informed consent of participants. Their assumption that proof of efficacy is all that matters because injuries and deaths following vaccination are always a "coincidence" is both unscientific and dangerous.

The human right to informed consent to all medical interventions which carry a risk of injury or death, including vaccination, should be made law in every country and there should be criminal and economic sanctions for all those who violate it during the course of clinical research or the practice of medicine.

Corrupt Chinese FDA Chief Executed

"Why are the friends who gave me money all the bosses of pharmaceutical companies?" he wrote in his [confession] letter, entitled How I Look on My Mistakes. "Obviously because I was in charge of drug administration."....."There were so many companies going to him and he simply couldn't resist the temptation," said one drug company executive who befriended Mr. Zheng in the 1980s and did not want to be identified discussing the delicate issue......Eventually, the court found him guilty of accepting bribes from eight drug companies, condemned him for dereliction of duty for failing to police the drug industry or his subordinates and creating regulatory schemes that allowed dangerous drugs to come to the market. Industry officials say Mr. Zheng probably accepted many more bribes, but the government did not need evidence of any more to ask for the death penalty.....Mr. Zheng's lawyer pleaded for leniency, saying his client had cooperated with the authorities and, at times at least, had actually worked to improve the drug industry. But on July 10, the state- run media issued a terse statement: "Zheng Xiaoyu, former director of China's State Food and Drug Administration, was executed Tuesday morning with the approval of the Supreme People's Court." - David Barboza, New York Times,
A Chinese Food and Drug Official Betrays His Cause, and Pays

Barbara Loe Fisher Commentary:

The execution of a former head of the Chinese Food and Drug Administration, who began his career in government as a consumer advocate determined to strongly regulate the pharmaceutical industry and ensure the safety of drugs and vaccines, may seem extraordinarily harsh. However, his choice to betray the people and take money from an industry he was responsible for regulating in exchange for allowing dangerous drugs, vaccines and food to be marketed, caused the deaths and compromised the health of thousands of innocent people in China and other countries.

What is the appropriate societal sanction for powerful leaders in government whose irresponsible, immoral actions kill and injure members of a trusting public? An equally important question: what is the appropriate societal sanction for wealthy drug company officials, who participate in corrupting government employees responsible for regulating pharmaceutical and other consumable products that end up injuring and killing people? Sanctions for drug company lobbyists, who give financial incentives to doctors and politicians to push widespread use of pharmaceutical products that carry serious health risks - or even legally require their use - is another outstanding issue.

The corruption of a once honest man by corporate executives exploiting people for profit is a human tragedy. The people doing the corrupting should not be left off the hook. Equally important is the need for politicians in every country to refrain from putting too much power to regulate and recommend pharmaceutical product use in the hands of one unelected bureaucrat working for a government health agency.

Mechanisms for strong public participation and oversight should be an integral part of any public health program that involves government or physician recommended use of pharmaceutical products. Absolute power corrupts absolutely.

CA Politicians Forcing HPV Vaccine

"If AB 16, and companion bills SB 533 and SB 676 are enacted, the following mandatory vaccine schedule will be imposed on every child from birth to 12 years old in California beginning on July 1, 2008. Every year thereafter, all new vaccines recommended by ACIP will be routinely added as well, with no limit on the number of new vaccines that can be added at one time. With over 300 new vaccines currently in development, there will be no end to the madness. If AB 16 and the others become law, in less then one year children in California will be receiving 14 more shots then they are receiving today. " - Rick Rollens, Parent, Founder MIND Institute

Barbara Loe Fisher Commentary:

California is on its way to becoming the first state to mandate Merck's GARDASIL vaccine for all 11 year old girls.

In a July 5 NVIC E-News, we reported that the California legislators, who were sponsors of the failed HPV vaccine mandate earlier this year, were working with drug companies and doctors to make sure the public is never able to stop a new vaccine mandate again. They are sponsoring three bills that would re- write California public health law and make sure every vaccine marketed by Merck and other drug companies that is recommended by federal health officials now and in the future would be automatically mandated despite any public opposition. The original versions of the bills have been amended in the last few days to eliminate the five year waiting period after a new vaccine has been licensed by the FDA and make ALL existing and new vaccines, including Merck's GARDASIL, recommended by the CDC automatically mandated by July 1, 2008.

Merck has been very busy in the state of California.

With heavy lobbying by drug company lobbyists making and selling vaccines, together with medical organization lobbyists whose physician members profit from administering vaccines in their offices, Representative Ed Hernandez, an optometrist (D-West Covina) and Senators Mark Ridley-Thomas (D-26th District) and Leland Yee, Ph.D., a psychologist (D-San Franciso/San Mateo) are the three politicians most responsible for helping drug companies and doctors ram three pieces of legislation (AB 16, SB 533 and SB 676) through the California legislature.

Tomorrow, July 11, members of the Senate Health Committee are scheduled to vote on AB 16, including Senators Ridley-Thomas and Leland Yee. If AB16 or companion bills SB 533 and SB 676 are enacted, all 11 year old girls in California will be mandated to use GARDASIL beginning in July 2008 and all children will be required to use every other vaccine the CDC has ever endorsed.

Following is a list of members and email links of the Senate Health Committee members, whose vote tomorrow could hand over power to mandate new vaccines to one unelected Public Health Officer employed by the state, who takes direction from unelected federal public health employees in Atlanta. br> Click on their names to register YOUR vote.


Senator Sheila Kuehl (Chair)
Senator Samuel Aanestad (Vice Chair)
Senator Elaine Alquist
Senator Gilbert Cedillo
Senator Dave Cox
Senator Abel Maldonado
Senator Gloria Negrete McLeod
Senator Mark Ridley-Thomas
Senator Darrell Steinberg
Senator Mark Wyland
Senator Leland Yee


Click here to contact AB 16 sponsor Assemblyman Ed Hernandez, O.D. (D-57th District):

Click here to contact SB 676 sponsor Senator Mark Ridley- Thomas, Ph.D. (D-26th District):

"Click here to contact SB 533 sponsor Senator Leland Yee, Ph.D. (D-San Francisco/San Mateo):


The CDC currently recommends children get 49 doses of 14 vaccines by age six. This is double the numbers of vaccines the government "recommended" 25 years ago. If AB 16 or one of the two other companion bills become law, the numbers of vaccines California children are required to get could double or triple within the next decade and there will be nothing parents can do about it.

Following is a list of vaccines the CDC says all children should get and when they should get them:

Birth
Hepatitis B

2 months old
diphtheria
tetanus
pertussis
HIB
polio
pneumococcal
rotavirus
hepatitis B

4 months old
diphtheria
tetanus
pertussis
HIB
polio
pneumococcal
rotavirus

6 months old
diphtheria
tetanus
pertussis
HIB
pneumococcal
rotavirus
hepatitis B
influenza

12-18 months old
diphtheria
tetanus
pertussis
HIB
polio
measles
mumps
rubella
chicken pox
pneumococcal
influenza
hepatitis A (2 doses)

Two years old
influenza

Three years old
influenza

Four Years old
influenza

Five Years old
influenza

4-6 years old
diphtheria
tetanus
pertussis
polio
measles
mumps
rubella
chicken pox

11-12 years old
diphtheria
tetanus
pertussis
HPV (3 doses for girls)
meningococcal

Wakefield Defends As British Autism Rate Explodes

"Seven academics at Cambridge University, six of them from its renowned Autism Research Centre, undertook the research by studying children at local primary schools. Two of the academics, leaders in their field, privately believe that the surprisingly high figure may be linked to the use of the controversial MMR vaccine. That view is rejected by the rest of the team, including its leader, the renowned autism expert, Professor Simon Baron-Cohen. The team found that one in 58 [British] children has either autism or a related autistic spectrum disorder. Nationwide, that could be as many as 210,000 children under 16. The research is significant because that figure is well above the existing estimate of one in 100, which specialist bodies such as the National Autistic Society have until now accepted as correct. It is also significantly more than the previous highest estimate of one in 86, which was reported in research published last year in the Lancet." - Denis Campbell, The Observer - UK

"The results of the study, which was purely statistical and did not examine the possible medical causes of autism, so worried Professor Baron-Cohen that he contacted health officials in Cambridgeshire. However, the professor - who is a first cousin of the comedian Sasha Baron-Cohen - stressed he did not believe the MMR vaccine was behind the apparent increase. Professor Baron-Cohen said: "As for MMR, at this point one can conclude that evidence does not support the idea that the MMR causes autism." He said he believed a better understanding of autism and environmental factors such as exposure to chemicals and hormones were more likely to be behind the recorded increase." - Stephen Adams, The Telegraph - UK

"As Vaclav Havel once said: "Follow the man who seeks the truth; run from the man who has found it." I can't tell you that we know that the MMR vaccine causes autism. But the Department of Health can tell you with 100 per cent certainty that it doesn't, and they believe that, and that concerns me greatly....... it's biologically plausible that the MMR vaccine causes or contributes to the disease in many children, and nothing in the science so far dissuades me from the continued need to pursue that question', Wakefield said. 'The trend in autism has gone up sharply in many countries. It's interesting that that increase coincides in many places with the introduction of the MMR vaccine. That doesn't make it the cause. But it's an observation that needs to be explained, because there was clearly some environmental change at that time that led to growing numbers of children becoming autistic. It's a legitimate question if MMR is one of those factors. I fear that it may be..... 'The hypothesis that we have been pursuing for some years is that the vaccines in some way may interact to increase the risk of the measles element in the MMR jab damaging the intestine, and possibly the brain directly, or alternatively that the intestinal disease leads to secondary immune injury to the developing brain." - Andrew Wakefield quoted by Denis Campbell, The Observer - UK , I told the truth all along, says doctor at heart of autism row. In his only interview before he appears in front of the General Medical Council to face serious charges of malpractice, the campaigner against the MMR vaccine tells Denis Campbell that he has no regrets

Barbara Loe Fisher Commentary:

The CDC acknowledges that 1 in 150 children in the U.S. is autistic. British autism researchers this week confirmed that the rate of autism in Great Britain has risen to 1 in 58 children. Assuming that the child populations studied in the U.S. and Brtiain are comparable, it suggests that autism is either three times more prevalent in Britain than in the U.S. or that the prevalence of autism among American children is grossly underestimated.

Although much of the focus about vaccine risks in the U.S. during the past six years has centered on the mercury preservative, thimerosal, in Britain the vaccine safety debate has focused on children who have regressed after receiving MMR vaccine. With so little basic science research into the biological mechanisms of vaccine injury and death or genetic co- factors, there are large gaps in scientific knowledge about the way vaccines act singly or in combination in the human body to cause brain and immune system dysfunction in young children. It is still too early to conclude that one vaccine ingredient or one combination of live virus vaccines are solely responsible for autism increases among children.

With so many unanswered scientific questions about why and how vaccines cause harm to certain children, all scientific inquiries should be welcomed and no hypothesis should be dismissed before it is thoroughly explored. Andrew Wakefield is essentially being tried by his peers in Britain for daring to explore the politically incorrect hypothesis that the MMR vaccine may be associated with the development of regressive autism in some children. His refusal and the refusal of two of his colleagues to recant their scientific findings in order to save their license to practice medicine should be cherished by all who believe in freedom of thought and speech.

The spectacle that this British Medical Inquisition is creating for the world to see will have repercussions far beyond the three martyrs it will make. The people are not stupid and they will not soon forget that medical doctors inside and outside of the British government so feared one man's scientific discovery about vaccination that they felt they had no choice but to destroy him and anyone who stands with him.

Whatever the avenging vaccinologists in Great Britain do to Andrew Wakefield and his brave colleagues will not wipe away the sickening reality that one of the most highly vaccinated child populations in the world is also among the most disabled, with 1 British child in 58 suffering with autism or autism spectrum disorder.

Andrew Wakefield, M.D.

Chronic Illness Epidemic: Unvaccinated Children Healthier

"There are 33 doses of 9 different vaccines that our children now have to get to attend school. There are 200 vaccines being created, including an AIDS vaccine that Dr. Halsey said she be used by all 12 year olds. The issue is not whether or not we should use a few vaccines to control a few serious diseases but whether or not we are over-vaccinating our children and setting them up for chronic disease later in life.....parents should be fully informed about all risks and then be able to make an informed consent decision. The issue is whether we are going to have the right in this country as Americans to freely choose the kind of preventive health care we want for our families, including which vaccines we use, or whether we are going to have that right taken from us by public health officials.....we do not know if all these vaccines were are giving our children are contributing to chronic disease later in life. We are becoming a sicker and sicker society." - Barbara Loe Fisher, The Today Show, January 1997 (Live debate with Neal Halsey, M.D.)

"The committee was unable to address the concern that repeated exposure of a susceptible child to multiple immunizations over the developmental period may also produce atypical or non-specific immune or nervous system injury that could lead to severe disability or death. (Fisher, 2001) There are no epidemiological studies to address this. Thus, the committee recognizes with some discomfort that this report addresses only part of the overall set of concerns of some of those most wary about the safety of childhood immunization." - Institute of Medicine, National Academy of Sciences, Multiple Immunizations and Immune Dysfunction (2002)

"Surveys were mailed to 2964 member households of the National Vaccine Information Center, which represents people concerned about vaccine safety, to ascertain vaccination and atopic disease status. The data included 515 never vaccinated, 423 partially vaccinated, and 239 completely vaccinated children. In multiple regression analyses there were significant (P < .0005) and dose- dependent negative relationships between vaccination refusal and self-reported asthma or hay fever only in children with no family history of the condition and, for asthma, in children with no exposure to antibiotics during infancy. Vaccination refusal was also significantly (P < .005) and negatively associated with self-reported eczema and current wheeze. A sensitivity analysis indicated that substantial biases would be required to overturn the observed associations. - Enriques R, Addington W, et al, Journal of Allergy and Clinical Immunology (April 2005)

"The number of American children with chronic illnesses has quadrupled since the time when some of their parents were kids, portending more disability and higher health costs for a new generation of adults, a study estimates. An almost fourfold increase in childhood obesity in the past three decades, twice the asthma rates since the 1980s, and a jump in the number of attention-deficit disorder cases are driving the growth of chronic illnesses, according to researchers at Harvard University in Boston. The report is published in a this month's issue of the Journal of the American Medical Association focusing on children's health..... In 1960, just 1.8 percent of U.S. children and adolescents were reported to have a chronic health condition that limited their activities. In 2004, the rate rose to 7 percent, researchers said. `"We will see much greater expenditures for people in their 20s than we ever saw before, and no one is thinking how we should prepare for that,'' said James Perrin, professor of pediatrics at Harvard Medical School and the report's lead author, in an interview. "We call it an epidemic. It's certainly worrisome and we look at it as a call to action.'' - Angela Zimm, Bloomberg News Service, June 2007

"A new, privately funded survey finds vaccinated U.S. children have a significantly higher risk of neurological disorders -- including autism -- than unvaccinated children. In one striking finding, vaccinated boys 11-17 were more than twice as likely to have autism as their never-vaccinated counterparts. The telephone survey of parents representing a total of 17,000 children appears to be the first of its kind -- and contrasts starkly with several government-backed studies that have found no risk from vaccines. "No one has ever compared prevalence rates of these neurological disorders between vaccinated and unvaccinated children," said J.B. Handley, father of a child with autism and co-founder of Generation Rescue, which commissioned the $200,000 survey conducted by SurveyUSA, a respected marketing firm. "The phone survey isn't perfect, but these numbers point to the need for a comprehensive national study to gather this critical information." - Dan Olmsted, UPI, June 2007


Barbara Loe Fisher Commentary:

This past week, the results of two studies were released which supports several decades of mounting evidence that an epidemic of chronic brain and immune system disorders has developed among American children in the past quarter century and that the use of multiple doses of multiple vaccines given to children early in life may play a major role. These two new studies, one conducted by researchers at Harvard University and one conducted by Generation Rescue, reinforce findings of an asthma study conducted by researchers at University of Illinois, Chicago published in 2005. All three studies validate the repeated warnings since the early 1990's by parents of vaccine injured children that over-vaccination of infants and toddlers may be contributing to increases in learning disabilities, ADD/ADHD, asthma, diabetes and autism among older children.

While the Harvard study confirmed the existence of a chronic disease and disability epidemic among American children, including a prevalence of six percent of all children with ADHD and nine percent with asthma, it was the $200,000 private funding of a west coast telephone survey by Generation Rescue founder JB Handley which revealed a much higher risk of neurological disorders in vaccinated versus unvaccinated children that deserves special attention and immediate follow-up. The survey found that "Among more than 9,000 boys age 4-17, vaccinated boys were 2.5 times (155 percent) more likely to have neurological disorders, 224 percent more likely to have attention deficit hyperactivity disorder, and 61 percent more likely to have autism."

This evidence reinforces information published in the Journal of Allergy and Clinical Immunology in 2005 that there are marked differences between the incidence of self-reported asthma in vaccinated and unvaccinated children by parents, with a finding that parents of unvaccinated children were "11 times less likely to report asthma" and "10 times less likely to report hay fever" among children with no family history of either condition. NVIC staff worked for four years with researchers at the University of Illinois to design and implement the study entitled "The Relationship between Vaccine Refusal and Self-Report of Atopic Disease in Children." The study methodology, which included the formal Institutional Review Board (IRB) process and peer review, involved mailing of surveys to 2,964 randomly selected households of members of NVIC with children aged 3 to 18 years, a database which includes families with highly vaccinated, partially vaccinated and totally unvaccinated children.

These studies follow three congressionally mandated reports in 1991 and 1994 published by the Institute of Medicine (IOM), National Academy of Sciences, which reviewed the medical literature and confirmed that vaccines can cause brain and immune system dysfunction as well as death. When, at the request of the Centers for Disease Control, the Institute of Medicine convened another committee of physicians to examine scientific evidence that vaccines cause brain and immune system dysfunction, I made the following statement at a January 2001 IOM public workshop:

"There is a compelling argument to be made that the dramatic increase in chronic brain and immune dysfunction in children, especially the rising number of reports of regression in previously healthy children, is due to an early exposure that is being experienced by all children but which is harming an expanding minority of them.... Many biological responses are at least partially under genetic control. If, for example, adverse responses to vaccination are tied to the genes responsible for predisposition to autoimmunity and immune-mediated neurological dysfunction, then it is possible that the addition of more doses of vaccines to the routine schedule in the past two decades has affected more and more children with that genetic predisposition.....Therefore, when all children only were exposed to DPT and polio vaccine in the early 1960's, a tiny fraction of the genetically susceptible responded adversely. But with the addition of measles, mumps and rubella to the routine schedule in 1979, and then HIB, hepatitis B and chicken pox in the late 1980's and 1990's, far more of the genetically susceptible have been brought into the adverse responder group."
http://www.nvic.org/Loe_Fisher/blftestimony_iom_safety.htm

In their 2002 published report on "Multiple Immunizations and Immune Dysfunction" the Institute of Medicine stated:

"The committee was unable to address the concern that repeated exposure of a susceptible child to multiple immunizations over the developmental period may also produce atypical or non-specific immune or nervous system injury that could lead to severe disability or death. (Fisher, 2001) There are no epidemiological studies to address this. Thus, the committee recognizes with some discomfort that this report addresses only part of the overall set of concerns of some of those most wary about the safety of childhood immunization." ( http://www.iom.edu/CMS/3793/4705/4432.aspx)

Scientifically confirming that the repeated atypical manipulation of the immune system with multiple vaccines in early childhood is contributing to chronic disease and disability increases would require additional methodologically sound epidemiological studies as well as basic science research into the different biological mechanisms involved in vaccine induced brain and immune system dysfunction. Future studies comparing groups of vaccinated to groups of unvaccinated children and adults should include not only evaluation of all morbidity and mortality outcomes but also identify genetic variability and measure pathological changes at the cellular and molecular level in the vaccinated and unvaccinated, including changes in immune function (blood tests), brain function (EEG, MRI) and chromosomal integrity over a 10 to 20 year period.

In 1982, parents of DPT vaccine injured children began urging federal health agencies, vaccine manufacturers and doctors to take seriously the reports of health deterioration after vaccination. We begged them to responsibly investigate the persistent reports by parents that healthy children were regressing physically, mentally and emotionally and being left with a variety of brain and immune system problems. Those warnings, which became more urgent in the 1990's, were ignored. Now the child chronic illness epidemic, which we predicted would occur if our warnings were ignored is here.

It is a sad commentary on the state of the public health that so many American children are so sick and there are still so many gaps in scientific knowledge about the ways that vaccines act in the human body to stimulate long term immunity or cause injury and death. The stubborn reluctance of government, industry and medicine to acknowledge the validity of reports by parents that children are getting sicker not healthier, despite using so many vaccines, may turn out to be the greatest medical scandal and human tragedy of the past century.

The Persecution of Andrew Wakefield, M.D.

"....parents who believe their children's autism has been triggered by the [MMR] vaccine are planning to show their support for the doctor outside next month's disciplinary hearing in London. In addition, an online petition to demand the government and health organisations "stop investigating the doctors and start investigating the patients" has collected more than 4000 signatures. Campaigner Bill Welsh, president of the Edinburgh-based Autism Treatment Trust, claimed Wakefield was the victim of a "medical establishment witch-hunt". "Dr Wakefield listened to the parents about their children's disease, clinically investigated the children and reported what he found - where is the crime in that?" he said. "This trial undermines the possibility of any future independent scientific research that might challenge establishment policy." The petition, started by campaigner Nigel Thomas - who has two brothers diagnosed with autism - states: "I have seen first-hand their decline, seen them screaming in pain and I have seen how all but a handful of doctors repeatedly refused to investigate their problems, brushing off the family's concerns and leaving us helpless, like thousands of other families around the world." - Judith Duffy, Sunday Mail

"This is not just about MMR, not just about mercury in vaccines and in the end, not just about autism. This is about a public health disaster of gigantic proportions that will affect this generation and generations to come, and those responsible must be brought to account. It is about the refusal of mainstream medicine to accept the consequences of their actions. It is about the refusal to treat a condition that is becoming almost commonplace; a condition for which the medical profession is largely responsible; a condition whose existence the medical profession ruthlessly denies in the light of its culpability. From its first day and for its duration the GMC hearing will be a window on this world of deceit. My brothers and I will be outside the building on day one and we will not be standing alone. Be there with us if you can, but at the very least, sign this petition for us to present on the day." - Nigel Thomas, Author, "Autism: Stop the Deceit, Start the Treatment Petition

"A former Government medical officer responsible for deciding whether medicines are safe has accused the Government of "utterly inexplicable complacency" over the MMR triple vaccine for children. Dr Peter Fletcher, who was Chief Scientific Officer at the Department of Health, said if it is proven that the jab causes autism, "the refusal by governments to evaluate the risks properly will make this one of the greatest scandals in medical history". He added that after agreeing to be an expert witness on drug-safety trials for parents' lawyers, he had received and studied thousands of documents relating to the case which he believed the public had a right to see. He said he has seen a "steady accumulation of evidence" from scientists worldwide that the measles, mumps and rubella jab is causing brain damage in certain children. But he added: "There are very powerful people in positions of great authority in Britain and elsewhere who have staked their reputations and careers on the safety of MMR and they are willing to do almost anything to protect themselves." - Sue Corrigan, Daily Mail

"My son had the MMR jab a week after his first birthday and suffered the normal side effects connected with the vaccine. However, his symptoms persisted and got dangerously worse. "Within a week he had a purple rash and his whole body had swollen up like the Michelin Man. He wouldn't stop screaming, it was quite clear he wasn't well. It did die down but all his normal functions, like eye contact and dialogue he knew before, had gone since the jabs. While in Alder Hey Children's Hospital with his older sister, I noticed a poster on the wall about autism which listed the symptoms, and he had seven of the 10. It was then I made the connection between the MMR jab and autism." Donna was referred to Rhuddlan Children's Centre and a consultant psychologist confirmed her son was autistic."- Samantha Castle, North Wales Weekly News

Barbara Loe Fisher Commentary:

In a few weeks, Andrew Wakefield, M.D., will be defending himself against charges of professional misconduct lodged against him by British physicians running the General Medical Council of England. At the heart of the matter is the medical establishment's fury at Dr. Wakefield for daring to publish an hypothesis in the Lancet in 1998 that provided clinical evidence for an association between MMR vaccine, intestinal bowel disease and autism. Subsequently, Dr. Wakefield suggested that some genetically vulnerable children might be unable to handle being injected with three live attenuated viral vaccines at once, pointing out that children rarely are simultaneously infected with wild type measles, mumps and rubella infections in nature.

Andrew Wakefield has steadfastly resisted pressure from government, medicine and the pharmaceutical industry to halt his research into autistic enterocolitis and the possible links between childhood vaccinations, intestinal inflammation and autism. That refusal to stop investigating the potential biological mechanisms for vaccine-induced autistic enterocolitis has made him a target for those determined to make an example out of him. Like individuals who are persecuted for holding different ideological, religious or political beliefs from those in power, Dr. Wakefield is being persecuted for taking a scientific position that does not conform with the majority of those operating or profiting from the global mass vaccination system.

It is sad to watch physicians devour one of their own out of ignorance, envy, greed and fear. The people of the world are witnessing this Great Inquisition. They will not forget the martyrdom of a physician, one of the brightest and best, who discovered a link between vaccination and regressive autism and did what he could to heal affected children and prevent others from suffering their fate.

Many parents of vaccine injured children - regardless of which biological mechanism was involved in their children's vaccine-associated regression into autism - support the pioneering work of Andrew Wakefield and his right to pursue his scientific investigation without being persecuted.

Mark Blaxill, co-founder of SAFEMINDS, said: "I'd like to urge you all to take a moment and to visit the petition site and sign the statement of support for Andy Wakefield. Andy has been a pioneer in autism treatment, leading the way in finding ways to diagnose our children's medical problems and to improve their health and development. Because he had the courage to question the established modalities of current public health programs (suggesting parents split the MMR vaccine and spread out its administration) and the safety of a combination vaccine (the MMR), he has been unfairly attacked, ruthlessly sanctioned, driven from his job and his home and declared a pariah by the scientific and medical establishment of the UK. Looking back on this episode, history will judge this reaction harshly. But in the meantime, things may get worse. Andy has been summoned to appear before the General Medical Council of England. There is a chance he will be struck from the medical register as punishment for his courageous actions.

"I can think of no one who deserves such treatment less than Andy Wakefield. Indeed, Andy deserves praise and accolades for his work. He stands for a model of personal conduct to which other clinician/scientists should aspire. He treats his patients with compassion and their parents with respect. He listened to the families of autistic children when no one else did. He led rigorous scientific investigations into the nature of the gastrointestinal inflammation that so many of us have observed in our children. He made the scientific case for the biomedical approach to autism treatment when the field was only just emerging and needed the scientific rigor he brought to the work. He persevered in the face of obstacles that few other scientists would have endured. And he has done all of these things with unfailing good grace, an open and generous spirit and without rancor or bitterness."

To read and sign the petition supporting Andrew Wakefield, M.D., go to
http://www.ipetitions.com/petition/GMC/.

No donation is necessary when signing the petition, which originates and is being maintained in Britain.

NY Times: Autism Debate Strains Families

"No parent or grandparent could read the article about dissension within families with autistic children without deep sadness. Although the causes for regressive autism are most likely multifactoral, one possible co-factor - vaccination - stimulates the most intense debate. Like any other medical intervention, vaccination carries a risk that is greater for some than for others, a fact confirmed in 1991 and 1994 by the Institute of Medicine in historical reviews of the medical literature. But all of the potential biological mechanisms and genetic or other high-risk factors involved have not been identified. It is important to support the quest for answers led by parents whose children suffer with brain and immune system dysfunction. All potential causes should be explored and re-examined in the search for why some healthy children suddenly regress and become autistic. Science, like opinion, evolves over time." - Barbara Loe Fisher, New York Times

"A year after their grandson Christian received a diagnosis of autism in 2004, Bob Wright, then chairman of NBC/Universal, and his wife, Suzanne, founded Autism Speaks, a mega-charity dedicated to curing the dreaded neurological disorder that affects one of every 150 children in America today. The Wrights' venture was also an effort to end the internecine warfare in the world of autism - where some are convinced that the disorder is genetic and best treated with intensive therapy, and others blame preservatives in vaccinations and swear by supplements and diet to cleanse the body of heavy metals.......The Wrights' daughter, Katie, the mother of Christian, says her parents have not given enough support to the people who believe, as she does, that the environment - specifically a synthetic mercury preservative in vaccines - is to blame. No major scientific studies have linked pediatric vaccination and autism, but many parents and their advocates persist, and a federal "vaccine court" is now reviewing nearly 4,000 such claims. The Wright feud has played out in cyberspace and spilled into Autism Speaks, where those who disagree with Katie Wright's views worry that she is setting its agenda. And the family intent on healing a fractured community has instead opened its old wounds and is itself riven." - Jane Gross and Stephanie Strom, New York Times

Barbara Loe Fisher Commentary:

For more than two decades, the National Vaccine Information Center, co-founded in 1982 by parents of vaccine injured children, has advocated that a portion of the billions of taxpayer-supported research funds at NIH be used to fund methodologically sound scientific research into the biological mechanisms and high risk factors for vaccine-induced brain and immune system dysfunction. At no time is that research more needed than today, when millions of America's children are suffering with learning disabilities, attention deficit hyperactivity disorder (ADHD), autism, asthma, diabetes and other types of chronic illness and disability and the reports of regression following vaccination continue.

Recent calls by physician leaders in the fields of pediatrics and public health, including the influential Institute of Medicine in 2004, to end all research into vaccine-associated regressive autism, are not only premature but extremely unwise. While reasonable men and women can disagree about various scientific hypotheses regarding the plausible biological mechanisms and genetic factors involved when children regress after vaccination, the most intelligent course of action that can be taken at this critical juncture is to refrain from closing the door on any of those hypotheses. It may well turn out that every one of them is a co-factor, depending upon the individual child and the vaccine(s) involved.

The best way to find out why some children regress physically, mentally and emotionally after vaccination is for parents and physicians to keep an open mind about all possible reasons for the child's sudden health deterioration. If parents and physicians would become partners, rather than remain adversaries, in the search for answers to the most important public health question of our time, the answers would come much more quickly.

It is important for all cases of regression and health deterioration following vaccination to be reported to the federal Vaccine Adverse Events Reporting System (VAERS) and to NVIC's Vaccine Reaction Registry . Families who speak out about what happened to their child following vaccination are helping to raise public awareness that will, eventually, lead to appropriate scientific inquiry. You can post a report with or without a photo about what happened to your child (or other family member) after vaccination on NVIC's International Memorial for Vaccine Victims.

Gardasil Vaccine Breaking Budgets

"Merck & Co.'s [HPV] vaccine retails at about $360 for the 3-shot series. To put that in perspective, vaccinations for pneumonia cost $73 dollars. Polio runs at about $22. And to immunize children against three diseases - measles, mumps and rubella - the price is $124 dollars. And as for prevalence - most women may get HPV in their lifetime, as Wendelboe said.But a CDC study shows the cancer-causing strains that the vaccine protects against occur in less than 3% of women - far from the majority. And most strains go away on their own..........Currently, New Hampshire's budget for all childhood immunizations is $17.5 million. Most of that money comes from insurance companies and the Medicaid program. The HPV vaccine -so far- takes up almost $5 million, or 28% of that pie. And that $5 million will inoculate only 25% of all eligible girls." - Diane Finch, New Hampshire Public Radio

Barbara Loe Fisher Commentary:

When ideology and politics dominate vaccine policymaking rather than evidence based science, it is not only dangerous but it is very expensive.

In a March investigation of HPV vaccine costs for parents taking their young girls into private pediatricians offices in the Washington, D.C. area, NVIC found that parents could be charged anywhere from $525 to $930 for three GARDASIL shots depending upon whether the child was a first-time or current patient. Costs for the vaccine plus an administration fee ranged from $140 to $275 per shot with an additional office visit charge that fluctuated between $35 and $185, depending upon whether a nurse or doctor saw the child. Private insurance companies will have to raise insurance premiums for all their clients to reimburse for the high costs of GARDASIL.

Vaccine costs are not only borne by Americans at the state level, where state taxes are used to fund mandatory vaccination programs, but also at the federal level, where federal taxes are used to fund massive vaccination programs, such as Vaccines for Children (VFC), to provide vaccines to children at little or no cost to families who cannot afford to pay a private doctor. Every time the CDC recommends a new vaccine for universal use in all children, the health care costs associated with that recommendation can be counted in the tens of millions and billions of dollars over time.

The cost/benefit analysis for HPV vaccine does not hold up under scrutiny. As tragic as each individual death from cervical cancer is, there are many less expensive, more effective and safer ways to bring cervical cancer cases and deaths down, starting with making sure all sexually active girls and women are educated about HPV and undergo annual pap screening. Throwing a vaccine at a health problem is not the only answer.

At Risk: Truth About Vaccines, Lawsuits & Shortages

If you tell a lie big enough and keep repeating it, people will eventually come to believe it." - Joseph Goebbels (Jewish Virtual Library, American- Israeli Cooperative Enterprise).

"By the late 1970s fears of pertussis vaccine had spread to the United States. Before jurors persuaded more by emotional appeals than by science, lawyers successfully claimed that the pertussis vaccine caused sudden infant death syndrome (later found to be associated with sleep position), Reye's syndrome (later found to be associated with aspirin), unexplained coma, paralysis, mental retardation, and epilepsy. Seven companies stopped making the vaccine; within a few years only one, Lederle Laboratories, remained. Lederle was punished for its persistence. In 1986 a jury awarded $1.13 million to parents claiming that Lederle's pertussis vaccine had paralyzed their son -- an award that was more than half of the annual sales of the vaccine. Subsequent studies of hundreds of thousands of children showed that the risk of permanent brain damage was the same in children who had not received the vaccine as in those who had...... Unfortunately, the legacy of the pertussis litigation remains. Many pharmaceutical companies that abandoned vaccines never came back. At the beginning of the 1980s, 18 companies made vaccines; by the end of the decade, only four were left. The infrastructure to make vaccines became tenuous, and vaccine shortages became commonplace. For example, in 1998, the tetanus vaccine was in such short supply that its use was restricted to emergency rooms. Beginning in 2000, a pneumococcal vaccine for children -- designed to prevent bloodstream infections, meningitis, and a common cause of pneumonia -- was available only intermittently; parents could only hope that their children weren't among the thousands permanently harmed or killed every year by pneumococcus. Between 2003 and 2004 an influenza epidemic created a demand that dramatically exceeded supply; more than 150 children died that year from influenza. " - Paul Offit, Boston Globe

"The essay did note that Offit is co- inventor of the rotavirus vaccine currently licensed in the United States. The disclosure is helpful, but should have been more explicit. That vaccine is Merck's Rotateq, and Offit has served as a consultant to the drugmaker for many years. Merck has also been in the vaccine business for many years. In other words, Offit may be directly affected by any litigation that questions the worth of vaccines and, by extension, makes life more difficult for these companies. This is what he told UPI in 2003, before Rotateq was approved by the FDA: "I am a co-holder of a patent for a (rotavirus) vaccine. If this vaccine were to become a routinely recommended vaccine, I would make money off of that." - Ed Silverman, www.pharmalot.com

"Paul Offit attempts to rewrite history when he argues that the DPT vaccine does not cause brain inflammation and permanent brain injury in some children. Two large studies conducted in the United States and Britain, in which the children studied were enrolled prior to vaccination, demonstrated otherwise. The 1981 UCLA/FDA study published in Pediatrics compared DPT to DT vaccine and found that 1 in 875 DPT shots is followed within 48 hours by either a convulsion or collapse/shock episode. The case- controlled 1981 British National Childhood Encephalopathy Study found that the risk of brain inflammation within seven days of DPT vaccination is 1 in 110,000 DPT shots, with permanent brain damage occurring in 1 in 310,000 DPT shots. A re-analysis of the British study was validated in 1994 by the Institute of Medicine. Offit is entitled to his own opinion but not to his own facts. We have only ourselves to blame when we believe everything he says." - Barbara Loe Fisher, Boston Globe

Barbara Loe Fisher Commentary:

There are two reasons why people perpetuate a lie, even if they are not the original creators of it. Some do it out of ignorance or carelessness. Others do it deliberately with full knowledge. Sometimes it is difficult to determine whether facts are falsified deliberately or out of ignorance. Whatever the case, it is important to set the record straight when distortion of facts perpetuate a lie, especially when the lives of human beings are at stake.

A June 3 Boston Globe OpEd authored by Paul Offit, M.D. is littered with factual errors that perpetuate pharmaceutical industry-created myths, which have been used for two decades to persuade Congress to pass laws shielding vaccine makers from liability for vaccine injuries and deaths, while giving drug companies huge financial incentives to develop vaccines and lobby for vaccine mandates. Offit blames parents of DPT vaccine injured children seeking financial support for their children for driving drug companies out of the vaccine business. He does this even though he knows perfectly well there are more drug companies producing childhood vaccines today than in 1982.

Offit also blames parents of vaccine injured children for vaccine shortages even though he knows the main causes for vaccine shortages rest with the vaccine manufacturers themselves: production problems affecting distribution, incomplete compliance with FDA standards, and inaccurate predictions for public demand for a vaccine.

Offit further attempts to rewrite medical history by alleging that DPT vaccine does not cause brain damage. He does this even though he knows (1) the largest case controlled study ever conducted to investigate causes of brain damage in children, the 1981 British National Childhood Encephalopathy Study, concluded that the pertussis (whooping cough) portion of DPT vaccine causes acute brain inflammation and permanent brain damage; and (2) the Institute of Medicine agreed with that conclusion in 1994.

Although the federal vaccine injury compensation program (VICP) created by Congress in 1986 was not designed to function as the judge of whether a causal relationship between a particular vaccine and health outcome has been scientifically proven to exist - only to determine whether a child's injury could be reasonably presumed to be related to vaccination in the absence of a more plausible explanation - it is important to note that the vast majority of vaccine injury awards in the VICP have been for children suffering DPT vaccine brain injuries and deaths. Offit's attempt to exonerate DPT is part of a larger effort to convince the public - and drug company stockholders - that most vaccines, including his own, have no risks whatsoever.

A relatively small group of individuals worldwide personally profit from patents on childhood vaccines . However, a much larger group of individuals in the medical, research and public health professions in society benefit personally and professionally from government recommendations for universal use of many vaccines, recommendations that are subsequently turned into state vaccine mandates which generate millions, even billions, of dollars for vaccine manufacturers. Vaccine apologists and profiteers have a right to voice their opinions and legally make money in America's free enterprise system. However, their opinions should be put into proper perspective and the "facts" they use to aggressively promote widespread use of multiple vaccines and advocate one-size-fits-all vaccine policies should be verified before they become urban legend.

When the public trusts blindly, often what is most at risk is the truth.

The National Vaccine Information Center is committed to disseminating information about vaccines and infectious diseases in order to prevent vaccine injuries and deaths through public education and defend the informed consent ethic. Following is information about several myths being perpetuated by those who should know better, as well as a chronology of events between 1982 and 2007 that set the record straight.

MYTH #1: DPT vaccine injury lawsuits in the 1970's and 1980's drove most drug companies making vaccines out of US market; or specifically, as Offit states in the June 3, 2007 Boston Globe Op Ed, " at the beginning of the 1980's, 18 companies made vaccines, by the end of the decade, only four were left."

FACT: In 1982, there were four drug companies making and selling vaccines for children in the U.S.: Merck, Wyeth, Lederle and Connaught. In 2007, after two decades of mergers and acquisitions, there are six drug companies making and selling vaccines for children in the U.S.: Merck, Wyeth, Sanofi Pasteur, GlaxoSmithKline, MedImmune and Novartis. Foreign companies, like Australia's CSL Biotherapies, are poised to enter the lucrative US vaccine market soon. There are more than 200 vaccine trials in various stages worldwide and most vaccines being developed will be targeted by CDC officials and drug company lobbyists for widespread use in order to guarantee stockholder profits for vaccine manufacturers.

MYTH #2: Because DPT vaccine injury lawsuits in the 1970's and 1980's drove drug companies out of the US market, vaccine shortages occurred and continue to occur; specifically, Offit blames "the legacy of pertussis litigation" for shortages of tetanus vaccine "in 1998," pneumococcal (Prevnar) vaccine "beginning in 2000" and influenza vaccine "between 2003- 2004."

FACT: In a 2002 Government Accounting Office (GAO) investigation and report,"Childhood Vaccines: Ensuring an Adequate Supply Poses Continuing Challenges," the threat of vaccine injury lawsuits was not listed among reasons for vaccine shortages in the U.S.. Instead, the GAO identified primary reasons as (1) manufacturing production problems; (2) calls by immunization policy-making bodies to remove a preservative from vaccines as a precautionary measure; (3) a manufacturer's decision to cease production of some vaccines; and (4) greater than- expected demand for a vaccine that had recently been added to the immunization schedule.

Almost all of the vaccine shortages that the U.S. has experienced have been due to vaccine manufacturer production and government regulation compliance problems. Dr Offit should be well aware of reasons for vaccine shortages in the past decade because he was publicly identified as a member of the CDC's Advisory Committee on Immunization Practices (ACIP) from 1998 to 2003.

The shortage of adult tetanus vaccine occurred in early 2001, not 1998, when Wyeth-Lederle abruptly announced it had stopped production of tetanus-toxoid containing products, as well as DTaP vaccine. The 2002 GAO report revealed Wyeth had been planning to leave the DTaP and tetanus vaccine market but accelerated its departure when it realized it would have problems responding to FDA requirements to make "significant upgrades to its facilities where tetanus toxoid was manufactured." In addition, in August 2001, Merck temporarily suspended operations in one of its facilities manufacturing MMR and Varicella (chicken pox) vaccines to address issues raised by FDA inspectors during a plant inspection and to make scheduled modifications to its facility. According to the 2002 GAO report, the time it took to make plant modifications and difficulties in meeting FDA manufacturing requirements contributed to shortages of MMR, varicella, DTaP, and Td vaccines between the end of 2001 and summer of 2002.

The shortage of pneumococcal vaccine in 2001- 2002, occurred when Wyeth-Lederle aggressively promoted its vaccine after FDA licensure in 2000 but failed to correctly predict public demand for the vaccine that made Prevnar the best selling new pharmaceutical product in 2001. Although failure of supply to meet demand was the main reason for the shortage, the 2002 GAO report added ""the company's production of the vaccine was also hampered by ongoing manufacturing problems" and "changes made in the company's quality assurance procedures" to comply with FDA standards.

The shortage of influenza vaccine in 2003-2004 and flu-related deaths resulted when a more severe type of influenza circulating that year (A/Fujian) was not contained in the flu vaccine. CDC officials, who knew it but didn't tell Americans, publicized the deaths of children attributed to the Fujian flu in the fall of 2003 and urged that everyone get vaccinated, which generated a huge demand for flu vaccine that exceeded supply.
http://www.nvic.org/History/Newsl etters/%203770Reaction.pdf

MYTH #3: DPT vaccine does not cause brain inflammation and permanent brain damage; specifically Offit states that "Subsequent studies of hundreds of thousands of children showed that the risk of permanent brain damage was the same in children who had not received the vaccine as in those who had."

FACT: Of all the vaccines which have been routinely used by children in the past century, the brain damaging effects of the pertussis (whooping cough) portion of DPT vaccine is among the most well documented in the scientific literature. Created in 1912, the crude pertussis vaccine basically consisted of B. pertussis bacteria killed with heat, preserved with formaldehyde, and injected into children. In the early 1940's, aluminum was added as an adjuvant and later the mercury preservative, thimerosal, was added when pertussis was combined with diphtheria and tetanus vaccines to create DPT. Pertussis vaccine was never studied in large clinical trials before being given to children in the first half of the 20th century or after it was combined into DPT and recommended for mass use by the American Academy of Pediatrics in 1947.

The pertussis vaccine's ability to kill was first signaled in 1933 when T. Madsen reported two babies died within minutes of vaccination. In 1947, Matthew Brody gave detailed descriptions of two cases involving brain damage and death after pertussis vaccination. But, it was the 1948 published case study by Byers and Moll that gave the strongest warning that children were suffering brain inflammation within 72 hours of pertussis vaccination and being left with various kinds of brain damage. Forty years later, the prospective UCLA/FDA study published in Pediatrics in 1981 comparing DT and DPT vaccines would find that 1 in 875 DPT shots is followed by either a convulsion or collapse shock episode within 48 hours of vaccination.

Biological mechanisms for pertussis vaccine induced brain damage center on pertussis toxin (PT), one of the most lethal toxins in nature. Pertussis toxin is a known neurotoxin, a reliable inducer of brain inflammation and brain damage, which is why it is used in lab animals to deliberately induce EAE (experimental autoimmune encephalomyelitis). Pertussis toxin is implicated in brain inflammation caused by pertussis (whooping cough) complications as well as pertussis vaccine complications. Unfortunately, pertussis toxin is also thought to be responsible for stimulating immunity which is why it remains in DPT, DTaP and Tdap vaccines.. Other ingredients in DPT vaccine, which have been associated with neuroimmune dysfunction and may interact synergistically with pertussis toxin to cause shock, brain damage or death are: endotoxin, aluminum, and mercury.

After decades of reports in the medical literature that the pertussis portion of DPT vaccine was causing brain damage in some children, the large, case controlled National Childhood Encephalopathy Study was conducted in Britain and published in 1981. It confirmed a statistically significant association between pertussis vaccine or pertussis-containing vaccines (DPT) and acute brain inflammation leading to permanent brain damage. An NCES reanalysis 10 years later re-confirmed the finding. In 1994, the Institute of Medicine, National Academy of Sciences, published a report validating the conclusions of NCES, stating that " "the balance of evidence is consistent with a causal relation between DPT and the forms of chronic nervous system dysfunction in the NCES in those children who experience a serious acute neurological illness within 7 days after receiving DPT vaccine."

1982- 2007: FACTS ABOUT VACCINES, LAWSUITS & SHORTAGES

In April 1982, before the NBC Emmy award winning documentary "DPT: Vaccine Roulette" was broadcast and alerted American parents that children were suffering brain damage after receiving DPT vaccine, there were four commercial vaccine manufacturers producing and marketing childhood vaccines: Merck, Wyeth, Lederle and Connaught. In 1982, children were given only three vaccines: live oral polio vaccine (Lederle, sole source); MMR vaccine (Merck, sole source); and DPT vaccine (Wyeth, owned by American Home Products; Lederle, owned by American Cyanamid; and the Canadian corporation, Connaught shared the DPT market).

1982-1984: A series of congressional hearings were held in the U.S. Senate Committee on Labor and Human Resources on DPT vaccine safety.

April 1984: A jury in Idaho found Lederle negligent in the manufacture of DPT vaccine on strict liability grounds. Between 1978 and 1984, DPT vaccine injury cases had been settled out of court or the manufacturer had prevailed but a jury had never returned a guilty verdict against a DPT vaccine manufacturer. In Toner v Lederle, the Idaho jury awarded Kevin Toner $1.4M for paralysis he suffered after reacting with transverse myelitis to his first DPT shot at two months of age. Lederle was found guilty on the grounds of strict liability. The jury agreed with plaintiff's lawyers that a drug company could produce a vaccine that was "unavoidably unsafe" and passed FDA standards, while still being negligent for not doing everything it could do to reduce the risk associated with the vaccine. [Lederle would eventually appeal the decision to the Ninth Circuit Court of Appeals, which would uphold the jury verdict in an opinion written by Judge Anthony Kennedy, now serving on the US Supreme Court. In 1988, Lederle appealed to the US Supreme Court, who turned the case down, and the jury verdict and Ninth Circuit Court of Appeals decisions held.]

June 1984: Wyeth announced it was no longer going to produce and sell DPT vaccine, leaving the market to Lederle and Connaught. Merck, Lederle and Connaught increased pressure on Congress to pass legislation shielding them from liability by suggesting that if they were not protected, they would leave the nation without a vaccine supply.

December 1984: The CDC announced an emergency shortage of DPT vaccine and blamed it on the fact Wyeth abruptly ceased production of DPT due to DPT vaccine injury lawsuits. However, in testimony before the U.S. House Energy and Commerce Subcommittee on Health and the Environment, the vice president of Wyeth testified that the company was producing more vaccine in 1984 than it had in 1983 and planned to produce still more in 1985 because it was selling all of its pertussis vaccine to Lederle for Lederle to distribute. When questioned, federal health officials claimed they didn't know Wyeth was doing that.

February 1985: The book DPT: A Shot in the Dark by Coulter & Fisher was published by Harcourt Brace Jovanovich, documenting scientific evidence for DPT vaccine-induced brain and immune system dysfunction and included more than 100 new original case histories. The book would eventually be used by the Institute of Medicine as a reference for its 1991 report "Adverse Effects of Pertussis and Rubella Vaccines," which confirmed a causal relationship between DPT vaccine and acute encephalopathy.

1985: The FDA gave a license to Praxis Biologicals for the first HIB vaccine for use in 24 month old children and, shortly after, Lederle and Connaught also were given licenses to manufacture HIB vaccine.

1985: More than 200 lawsuits were pending in US courts against DPT vaccine manufacturers and pediatricians for DPT vaccine injury but most lawsuits continued to be settled on the courthouse steps for modest sums, after which all records were sealed from public view. Under pressure from drug companies and pediatricians to ensure the vaccine supply, Congress continued to hold hearings on a proposed federal vaccine injury compensation program. The program would provide a no-fault, expedited, less adversarial alternative to a court trial for families of catastrophically injured vaccine victims.

July 1986: After justifying a 10,000 percent in DPT vaccine prices to Congress by blaming it on DPT vaccine injury lawsuits, a July 25 hearing of the House Subcommittee on Health and the Environment heard charges that Lederle told the Securities and Exchange Commission, Wall Street and prospective investors that DPT vaccine injury lawsuits pose no risk of "material adverse effect" on the company. A US House Subcommittee report revealed $16.2 million was paid in settlements by US vaccine manufacturers to 52 children injured by all childhood vaccines (DPT, MMR and polio) during the previous five years, which worked out to an average of $300,000 per case. Out of the 15 cases that went to jury trial, the manufacturers won four cases, lost six and five were on appeal.

November 1986: President Reagan signed the National Childhood Vaccine Injury Act creating the federal Vaccine Injury Compensation Program (VICP), the National Vaccine Program, and instituting safety provisions in the mass vaccination system which required doctors to give parents benefit and risk information before vaccination; to report serious health problems following vaccination to a centralized federal Vaccine Adverse Events Reporting System (VAERS); to write down serious health problems following vaccination in a child's permanent medical record; and to keep a permanent record of all vaccines and lot numbers administered. Under the law, the VICP would use a Table of Compensable Events to determine whether a child's injury would automatically be presumed to be vaccine-related in the absence of a more plausible explanation. A provision in the law required the National Academy of Sciences, Institute of Medicine, to assemble physician committees to review the medical literature for evidence that vaccines can cause injury and death.

1986: The FDA gave Merck a license for the first recombinant DNA vaccine, hepatitis B vaccine

1987: Wyeth and Ayerst merged into Wyeth- Ayerst.

December 1987: The FDA gave a license to Connaught for a conjugate HIB vaccine.

1988: The FDA gave Lederle a license for a conjugated HIB vaccine and the CDC recommended universal use of conjugate HIB vaccine for all children at 18 months.

1989: The British drug company, SmithKline Beecham (SKB), entered the lucrative US vaccine market and the FDA licensed SKB's genetically engineered hepatitis B vaccine.

1989: The FDA gave Merck a license for conjugated HIB vaccine.

1989: Praxis Biologicals was acquired by American Cyanamid to create Lederle- Praxis.

1989: The French Merieux Institute acquired Connaught Lab of Canada and became Pasteur Merieux.

January 1991: The CDC recommended the universal use of HIB vaccine and hepatitis B vaccine for all infants.

December 1991: The FDA gave Lederle a license for acellular DTaP vaccine for the fourth and fifth booster doses for children 18 months and older and, in 1992, Connaught received a license for acellular DTaP vaccine for booster doses.

January 1993: A unanimous US 4th Circuit Court of Appeals decision affirmed the right of seven adults and children who contracted polio from the oral polio vaccine between 1979 and 1987 to recover damages from the federal government because the FDA permitted vaccine manufactured by Lederle Labs to be released to the public even though the vaccine failed to meet FDA safety standards.

1993: The Vaccines for Children Program was established by Congress, which allocated federal funds to provide CDC recommended vaccinations for all children, without regard for ability to pay. Vaccine tracking systems were created.

1994: Wyeth-Ayerst acquired American Cyanamid and its subsidiary Lederle-Praxis to form Wyeth- Lederle.

1994: The Institute of Medicine published two congressionally mandated reviews of the medical literature, "Adverse Events Associated with Childhood Vaccines," which confirmed that vaccines can cause chronic brain and immune system dysfunction and death; and "DPT Vaccine and Chronic Nervous System Dysfunction," which confirmed a reanalysis of the findings of the 1981 landmark British National Childhood Encephalopathy Study (NCES). IOM concluded that "the balance of evidence is consistent with a causal relation between DPT and the forms of chronic nervous system dysfunction in the NCES in those children who experience a serious acute neurological illness within 7 days after receiving DPT vaccine."

March 1995: The FDA gave Merck a license for live varicella zoster (chicken pox) vaccine.

1995: The FDA gave SmithKline Beecham a license for the first hepatitis A vaccine.

1995: Public health officials at the Department of Health and Human Services, with the assistance of the Department of Justice officials, change the Table of Compensable Events in the VICP to reduce the numbers of children automatically awarded compensation under the Table; from this point on, almost all vaccine victims would be required to meet a higher causation standard for presumption in order to obtain an award in the VICP.

1996: The FDA gave Wyeth-Lederle and Pasteur Merieux licenses for their acellular DTaP vaccines for use in infants two months and older.

July 1996: The CDC recommended all 12-18 month old children receive varicella zoster (chicken pox) vaccine.

1997: The FDA gave a license to a new vaccine manufacturer to enter the US market, North American Vaccine, for DTaP vaccine and gave SmithKline Beecham a license for DTaP.

1998: Andrew Wakefield, M.D. and colleagues in Britain published a study presenting clinical evidence for an association between MMR vaccine, intestinal bowel dysfunction and autism.

1998: The CDC recommended acellular DTaP vaccine for all five doses to replace whole cell DPT.

August 1998: The FDA gave a license to Wyeth- Lederle for the first live rotavirus vaccine (monkey- human hybrid virus) and the CDC recommended it for universal use in all infants in early 1999.

1999: Pasteur Merieux merged with Aventis to become Aventis Pasteur.

May 1999: U.S. House Committee on Criminal Justice, Drug Policy and Human Resources of the Government Reform Committee helds a hearing on hepatitis B vaccine immune and brain dysfunction.

June 1999: The CDC recommended exclusive use of inactivated polio vaccine (IPV) for infants and children, to replace the live oral polio vaccine (OPV) that can cause vaccine strain polio in a vaccinated person or someone who comes into close contact with a recently vaccinated person's body fluids.

July 1999: The FDA and EPA jointly advised the vaccine manufacturers to remove thimerosal (mercury) preservatives from childhood vaccines as a precautionary measure after a congressionally mandated review of mercury in products revealed cumulative exposures from childhood vaccines that exceeded EPA guidelines.

July 1999: The CDC announced recommendations for use of rotavirus vaccine in infants was suspended due to reports of bowel obstruction in infants. Wyeth- Lederle withdraws the vaccine from the market in the fall.

August 1999: The U.S. House Government Reform Committee, chaired by Congressman Dan Burton, held the first of a several year series of investigative hearings on vaccine safety issues, including vaccines and autism.

August 1999: The FDA gave a license to Merck for thimerosal-free hepatitis B vaccine and thimerosal-free HIB vaccine and gave SmithKlineBeecham a license for a trace thimerosal hepatitis B vaccine in March 2000.

2000: SmithKline Beecham merged with Glaxo Wellcome to become GlaxoSmithKline.

February 2000: The FDA gave Wyeth- Lederle a license for the first 7-valent pneumococcal vaccine (Prevnar) and in June 2000 the CDC recommended it for universal use in all infants.

January 2001: Wyeth-Lederle abruptly announced it had stopped production of tetanus-toxoid containing products, as well as DTaP vaccine, leaving the market to Aventis Pasteur and GlaxoSmithKline. As a result, adult tetanus vaccine lagged behind demand between 2001-2002, temporarily resulting in Td shortages. The 2002 GAO report revealed the reasons behind Wyeth- Lederle's action: the company had been planning to leave the DTaP and Td market but accelerated its departure when it realized it would be difficult "to respond to requirements set forth in a consent decree with the federal government. To comply with these requirements, the company faced making significant upgrades to its facilities where tetanus-toxoid was manufactured."

2001: An hypothesis entitled Autism: A novel form of mercury poisoning by Sallie Bernard and others is published in Medical Hypothesis.

2001: Wyeth-Lederle's Prevnar vaccine became the number one best selling new pharmaceutical on the US market. However, Prevnar supply shortages occurred because Wyeth-Lederle had aggressively promoted the vaccine before and after licensure while failing to gauge public demand so supply fell far short of demand and caused temporary shortages (http://www.cdc.gov/mmwr/preview/mmwr html/mm5219a6.htm. In addition, there were significant manufacturing problems that reduced Prevnar production and release of vaccine in 2001 and 2002. A 2002 GAO report "Childhood Vaccines: Ensuring an Adequate Supply Poses Continuing Challenges" confirmed that "CDC estimates the monthly national need for this vaccine to be 1.3 million doses, but the manufacturer was only able to provide about half the needed doses during the first 5 months of 2002. Company officials said an extensive pre-education campaign resulted in record-breaking adoption of the vaccine. The company's production of the vaccine was also hampered by ongoing manufacturing problems. Changes made in the company's quality assurance procedures, partly to comply with the terms of a consent decree with the federal government, resulted in delays in the release of the vaccine. Manufacturing equipment problems also affected the manufacturer's ability to meet demand."

March 2001: The FDA gave Aventis Pasteur a license for thimerosal free DTaP vaccine.

April 2001: The Institute of Medicine issued a report on MMR vaccine and autism concluding that " the evidence favors rejection of the causal relationship at the population level between MMR vaccine and autistic spectrum disorders" but also stated that "the proposed biological models linking MMR vaccination to autism spectrum disorders, although far from established, are nevertheless not disproved" and urged further research be conducted.

August 2001: Merck temporarily suspended operations in one of its facilities manufacturing MMR and Varicella (chicken pox) vaccines to address issues raised by FDA inspectors during a plant inspection and to make scheduled modifications to its facility. According to the 2002 GAO report, the time it took to make plant modifications and difficulties in meeting FDA manufacturing requirements contributed to shortages of MMR, varicella, DTaP, and Td vaccines between the end of 2001 and summer of 2002.

September 2001: The FDA gave Chiron/Evans a license to manufacture flu vaccine with trace amounts of thimerosal.

September 11, 2001: Terrorists destroyed the World Trade Center in New York City. Within weeks, DOD officials suggested terrorists had weaponized smallpox and anthrax that could be used to attack and infect large numbers of Americans. In the name of national security, eventually drug company and government officials persuaded Congress to pass legislation (Homeland Security, MSEHPA, Bioshield, BARDA) giving sweeping new emergency powers to federal and state public health officials while appropriating billions of dollars to develop experimental bioterrorism and pandemic flu vaccines. At the same time, Congress yielded to drug company lobbyists and public health officials seeking liability shields for drug companies and vaccine administrators to absolve them from legal responsibility for vaccine injuries and deaths that occur in the future when the Secretary of Health declares a public health "emergency" and orders mass use of experimental vaccines.

October 2001: The Institute of Medicine issued a report on thimerosal-containing vaccines and neurodevelopmental disorders which concluded that the hypothesis, while not proven, is "biologically plausible" and called for further research.

February 2002: GlaxoSmithKline ceased manufacture and distribution of Lyme disease vaccine, citing insufficient market, after adults and children injured by Osp-A Lyme vaccine speak out about their reactions.

2002: American Home Products changed its name to Wyeth.

September 2002: The FDA gave Aventis Pasteur a license to manufacture a thimerosal-free influenza vaccine.

June 2003: The FDA gave a license to MedImmune for the first live virus nasally administered influenza vaccine (FluMist).

October 2003: The CDC recommended that children 6 to 23 months of age receive an annual flu vaccination.

2003-2004: A mini-epidemic of a more severe type of influenza caused by the A/Fujian strain occurred around the world, including the U.S. In spring of 2003, federal health agencies and the pharmaceutical industry knew the genetically mutated type A flu was emerging out of Asia and causing significant complications, including death, but chose not to include it in the 2003/2004 flu vaccine formula after the WHO voted to stay with strains that had been included in the previous year's formulation (A/Panama, A/Caledonia and B/Hong Kong). Without informing the public that the flu vaccine did not contain the strain of flu causing severe flu that season, the CDC heavily publicized child flu deaths in the fall of 2003 and Americans stood in long lines that fall and winter to get flu vaccine, which caused a vaccine shortage and subsequent CDC-recommended rationing of flu vaccine supplies. (http://www.nvic.org/History/Newsl etters/%203770Reaction.pdf). The FDA stated that "between October 2003 and early January 2004, the deaths of 93 children younger than 18 had been reported to the CDC, according to preliminary data" and eventually the CDC would state that 152 flu related deaths occurred in children younger than 18 that year.

May 2004: The Institute of Medicine published a report rejecting a causal relationship between thimerosal containing vaccines and autism, concluding that hypotheses generated to date concerning biological mechanisms for vaccine induced autism are theoretical only. The IOM Committee discouraged further scientific research into the vaccine-autism association.

Summer 2004: Influenza vaccine manufactured by the British Chiron Corporation, which provides about half the inactivated influenza vaccine for the U.S., was found to be contaminated with bacteria. There was a flu vaccine shortage in the US during the 2004-2005 season as a result.

2004: Aventis Pasteur merged with Sanofi to become Sanofi-Pasteur and one of the world's largest pharmaceutical companies.

October 2004: Two professors from the Harvard School of Public Health published an article in the Journal of the American Medical Association, stating "We independently searched reported jury verdicts and judicial decisions for cases involving flu vaccine and found only 10 reported cases in the last 20 years.....overall there is little evidence of significant litigation involving the flu vaccine....by all appearances the situation is not one in which a rational observer would conclude that litigation is a substantial burden on manufacturers."

October 2004: US District Court Judge Emmet Sullivan issued an injunction blocking DOD from ordering US soldiers receive anthrax vaccine without their informed consent, citing the reactive anthrax vaccine's "experimental" status because the FDA had never licensed it as effective for use against weaponized inhalation anthrax. [DOD would subsequently get around the injunction by requesting the Secretary of Health and Human Services utilize recently acquired Project Bioshield powers and issue an "Emergency Use" authorization].

December 2004: FDA gave Sanofi Pasteur a license for thimerosal-free influenza vaccine.

January 2005: The FDA gave Sanofi- Pasteur a license for a new meningococcal and diphtheria toxoid conjugate vaccine (Menactra) and in May 2005, the CDC recommended it for all 11-12 year old children.

April 2005: Evidence of Harm by David Kirby was published by St. Martin's Press, presenting documentation for an association between mercury containing vaccines and autism.

May 2005: The FDA gave GlaxoSmithKline a license for Tdap for use in children 10 to 18 years old and in June gave Sanofi Pasteur a license for Tdap for persons 11 to 64 years old, after which the CDC immediately recommended Tdap be given to all 11-12 year old children.

October 2005: The CDC recommended that all 12 month old infants routinely receive hepatitis A vaccine.

February 2006: The FDA gave Merck a license for a new live rotavirus vaccine (human-cow hybrid virus) and in March 2006 the CDC recommended it for all infants;

March 2006: The FDA gave Merck a license for the first HPV vaccine (GARDASIL) and in June 2006 the CDC recommended it for all 11 year old girls.

April 2006: Novartis acquired Chiron, entering the US flu vaccine market (FluViron)

May 2006: The FDA gave a license to Merck for herpes zoster (shingles) vaccine and in October 2006 the CDC recommended it for use by all Americans aged 60 and older.

By 2007 American children were being told by government health officials and pediatricians to get 48 doses of 14 vaccines by age six and 53-56 doses of 15 or 16 vaccines by age 12. In May 2007, CNN Money reported predictions that vaccine industry sales will more than double by 2010.