E-Newsletter January 2009 #1

Here is your update on TACA (Talk About Curing Autism). If you are new to our site... WELCOME! This newsletter is produced two to four times each month.

We are an autism education and support group. We want to make this e-newsletter informative for you. As always, contact us your thoughts and/or questions so we can improve it.

We focus on parent information and support, parent mentoring, dietary intervention, the latest in medical research, special education law, reviews of the latest treatments, and many other topics relating to autism. Our main goal is to build our community so we can connect, share and support each other.

Talk About Curing Autism (TACA) provides general information of interest to the autism community. The information comes from a variety of sources and TACA does not independently verify any of it. The views expressed herein are not necessarily TACA’s.

In this edition:


1. Find a TACA Meeting

2. Real Help Now Live Chat

3. TACA Regional Newsletters

General News

4. Study shows California's autism increase not due to better counting, diagnosis

5. UC Davis Study Authors: Autism is Environmental (Can We Move On Now?)

6. CDC director is out, government e-mail says

Vaccine News

7. Olmsted on Autism: Autism Explosion Followed Big Change in MMR Shot

8. Dr. Paul Offit: Fox in a Henhouse, the ACIP Years (1998-2003)

9. Pediatrician slams vaccine book

10. Top Federal Autism Panel Votes For Millions in Vaccine Research

11. What is Paul Offit's Problem?

12. Why Paul Offit Isn't Flexible on Vaccines

13. US doctors pay to hear Oregon town's vaccine views

14. Merck Focusing on Combination Vaccine

15. Fatherhood: Autism Roulette

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1 Find a TACA Meeting
Come to a TACA Meeting!

TACA holds monthly meetings in many locations throughout the United States that feature educational speakers on important topics and allow family members to connect with one another and stay on top of the latest information in the autism world. Each TACA group maintains a resource library of the latest autism books and tapes that can be checked out by members at no charge.

Check out our group listings: each contains information on TACA meetings and special events as well as a contact form.

Are you wondering what happens at a TACA meeting? Watch our video.

2 Real Help Now Live Chat

We are currently testing a new web feature: Live Chat with a TACA Parent. The image below indicates whether a TACA Parent is currently available. Please click on the image below to initiate a chat session.

And don't forget to join us online at TACA-USA Yahoo! group and Facebook!

3 TACA Regional Newsletters

Are you receiving TACA's regional newsletters with information on local TACA meetings and events? We can't send it to you if we don't know where you are! Please Join TACA (it's free) or update your membership to include your location. If you include your mailing address, you'll receive TACA's print newsletter, Talking Autism.

4 Study shows California's autism increase not due to better counting, diagnosis

(SACRAMENTO, Calif.) — A study by researchers at the UC Davis M.I.N.D. Institute has found that the seven- to eight-fold increase in the number children born in California with autism since 1990 cannot be explained by either changes in how the condition is diagnosed or counted — and the trend shows no sign of abating.

Published in the January 2009 issue of the journal Epidemiology, results from the study also suggest that research should shift from genetics to the host of chemicals and infectious microbes in the environment that are likely at the root of changes in the neurodevelopment of California's children.

"It's time to start looking for the environmental culprits responsible for the remarkable increase in the rate of autism in California," said UC Davis M.I.N.D. Institute researcher Irva Hertz-Picciotto, a professor of environmental and occupational health and epidemiology and an internationally respected autism researcher.

Hertz-Picciotto said that many researchers, state officials and advocacy organizations have viewed the rise in autism's incidence in California with skepticism.

The incidence of autism by age six in California has increased from fewer than nine in 10,000 for children born in 1990 to more than 44 in 10,000 for children born in 2000. Some have argued that this change could have been due to migration into California of families with autistic children, inclusion of children with milder forms of autism in the counting and earlier ages of diagnosis as consequences of improved surveillance or greater awareness.

Hertz-Picciotto and her co-author, Lora Delwiche of the UC Davis Department of Public Health Sciences, initiated the study to address these beliefs, analyzing data collected by the state of California Department of Developmental Services (DDS) from 1990 to 2006, as well as the United States Census Bureau and state of California Department of Public Health Office of Vital Records, which compiles and maintains birth statistics.

Hertz-Picciotto and Delwiche correlated the number of cases of autism reported between 1990 and 2006 with birth records and excluded children not born in California. They used Census Bureau data to calculate the rate of incidence in the population over time and examined the age at diagnosis of all children ages two to 10 years old.

The methodology eliminated migration as a potential cause of the increase in the number of autism cases. It also revealed that no more than 56 percent of the estimated 600-to-700 percent increase, that is, less than one-tenth of the increased number of reported autism cases, could be attributed to the inclusion of milder cases of autism. Only 24 percent of the increase could be attributed to earlier age at diagnosis.

"These are fairly small percentages compared to the size of the increase that we've seen in the state," Hertz-Picciotto said.

Hertz-Picciotto said that the study is a clarion call to researchers and policy makers who have focused attention and money on understanding the genetic components of autism. She said that the rise in cases of autism in California cannot be attributed to the state's increasingly diverse population because the disorder affects ethnic groups at fairly similar rates.

"Right now, about 10 to 20 times more research dollars are spent on studies of the genetic causes of autism than on environmental ones. We need to even out the funding," Hertz-Picciotto said.

The study results are also a harbinger of things to come for public-health officials, who should prepare to offer services to the increasing number of children diagnosed with autism in the last decade who are now entering their late teen years, Hertz-Picciotto said.

"These children are now moving toward adulthood, and a sizeable percentage of them have not developed the life skills that would allow them to live independently," she said.

The question for the state of California, Hertz-Picciotto said, will become: 'What happens to them when their parents cannot take care of them?'

"These questions are not going to go away and they are only going to loom larger in the future. Until we know the causes and can eliminate them, we as a society need to provide those treatments and interventions that do seem to help these children adapt. We as scientists need to improve available therapies and create new ones," Hertz-Picciotto said.

Hertz-Picciotto and her colleagues at the M.I.N.D Institute are currently conducting two large studies aimed at discovering the causes of autism. Hertz-Picciotto is the principal investigator on the CHARGE (Childhood Autism Risk from Genetics and the Environment) and MARBLES (Markers of Autism Risk in Babies-Learning Early Signs) studies.

CHARGE is the largest epidemiologic study of reliably confirmed cases of autism to date, and the first major investigation of environmental factors and gene-environment interactions in the disorder. MARBLES is a prospective investigation that follows women who already have had one child with autism, beginning early in or even before a subsequent pregnancy, to search for early markers that predict autism in the younger sibling.

"We're looking at the possible effects of metals, pesticides and infectious agents on neurodevelopment," Hertz-Picciotto said. "If we're going to stop the rise in autism in California, we need to keep these studies going and expand them to the extent possible."


The study was funded by grants from the National Institute of Environmental Health Sciences (NIEHS) and by the M.I.N.D. Institute.

In 1998, dedicated families concerned about autism helped found the UC Davis M.I.N.D. (Medical Investigation of Neurodevelopmental Disorders) Institute. Their vision? Experts from every discipline related to the brain working together toward a common goal: curing neurodevelopmental disorders. Since that time, collaborative research teams at the M.I.N.D. Institute have turned that initial inspiration into significant contributions to the science of autism, fragile X syndrome, Tourette's syndrome, learning disabilities and other neurodevelopmental disorders that can limit a child's lifelong potential.

5 UC Davis Study Authors: Autism is Environmental (Can We Move On Now?)
David Kirby on the Huffington Post

I have always said there may be a small percentage of people with autism spectrum disorder (perhaps those with Asperger Syndrome) whose symptoms are a result only of their genetic makeup, with no environmental factors involved at all.

But a new study out of UC Davis' MIND Institute says that it's time to abandon science's long, expensive, and not very fruitful quest to find the gene or genes that cause autism alone, without any environmental triggers.

"We need to keep (environmental) studies going," Irva Hertz-Picciotto, the co-author of the study and professor of environmental and occupational health and epidemiology at UC Davis, said in a statement.

"We're looking at the possible effects of metals, pesticides and infectious agents on neurodevelopment," Hertz-Picciotto said. "If we're going to stop the rise in autism in California, we need to keep these studies going and expand them to the extent possible."

Autism is predominantly an environmentally acquired disease, the study seems to conclude. Its meteoric rise, at least in California, cannot possibly be attributed to that shopworn mantra we still hear everyday, incredibly, from far too many public health officials: It's due to better diagnosing and counting.

The autism epidemic is real, and it is not caused by genes alone: You cannot have a genetic epidemic. It really is time that we, as a society, accept that cold, hard truth.

"It's time to start looking for the environmental culprits responsible for the remarkable increase in the rate of autism in California," Dr. Hertz-Piccotto said.

The study results suggest that "research should shift from genetics, to the host of chemicals and infectious microbes in the environment that are likely at the root of changes in the neurodevelopment of California's children," the statement added.

The UC Davis Study, funded in part by the National Institute of Environmental Health Sciences (NIEHS) found that the rate of autism among six-year-olds in California mushroomed from less than 9 per 10,000 among the 1990 birth cohort, to more than 44 per 10,000 for kids born in 2000.

This increase, "cannot be explained by either changes in how the condition is diagnosed or counted," the statement said, "and the trend shows no sign of abating."

(It is important to keep in mind that almost every child born in 2000 would have received many vaccines that contained the mercury preservative thimerosal, which was not completely phased out of most - but not all - childhood vaccines until at least 2003.)

Of the 600-to-700 percent increase in autism reported in California between 1990 and 2000, fewer than 10 percent were due to the inclusion of milder cases, the study found, while only 24 percent could be attributed to earlier age at diagnosis.

There was only one logical conclusion: some thing or things in the environment had to be at play here.

I have always said that all environmental factors should be considered in at least some subgroups of autism. This position has been met with considerable ridicule. I believe that opponents are afraid that, if we start looking at toxins like heavy metals, it might one day lead back to thimerosal. Likewise, if we consider live virus triggers, we may have to take another look at the measles-mumps-rubella vaccine (which thousands of parents swear was the trigger than sent their children tumbling into autism).

Now, it's always been easier and more reassuring to tell ourselves that autism was almost purely genetic, that it was always with us at the rate of 1 in 90 men (1 in 60 in New Jersey) and that, gee, weren't doctors doing a great job these days of recognizing and diagnosis this disorder.

This pathetic groupthink has helped create hugely lopsided funding priorities in autism, where genetic studies get lavishly funded, while environmental ones are lucky to even pick up the dollar scraps left behind

"Right now, about 10 to 20 times more research dollars are spent on studies of the genetic causes of autism than on environmental ones," Hertz-Picciotto said. "We need to even out the funding."

I agree.

Yes, we must continue to look for the susceptibility genes that make some kids more vulnerable to environmental triggers - possibly through a diminished capacity to detoxify themselves.

But the sooner our best minds in science and medicine come to grips with the fact that these poor, hapless kids have been exposed to the wrong environmental toxins and/or infectious agents at the wrong time, the sooner we can find out how to best treat what really ails them.

It is illogical for us to oppose the study of, say, mercury exposures and autism, because it might somehow implicate thimerosal, and by extension, vaccines.

After all, heavy metal studies into autism could very well incriminate background environmental sources, but exonerate metal sources found in vaccines, such as mercury and aluminum.

And that would be a good thing for everyone.

6 CDC director is out, government e-mail says
Associated Press

By MIKE STOBBE – 3 days ago

ATLANTA (AP) — The woman who led the nation's public health agency in a post-Sept. 11 world of bioterrorist fears is out, her resignation announced in a Friday night e-mail to employees.

Dr. Julie Gerberding has resigned as director of the Atlanta-based U.S. Centers for Disease Control and Prevention, and will be replaced on an interim basis by a deputy as of Jan. 20, the day President-elect Barack Obama is inaugurated.

The e-mail obtained by The Associated Press that discloses the news was sent Friday night to employees of the U.S. Department of Health and Human Services, the umbrella agency over CDC.

Although an HHS housecleaning has been expected with the new administration, Gerberding's fate was somewhat unclear. The first woman to head the agency, Gerberding led the CDC through a post-Sept. 11 world of bioterrorist fears and was considered an effective communicator with legislators and the public.

In a November e-mail to staff, Gerberding said she expected she might be leaving her job after the Bush administration left office. But colleagues said she quietly had held out hope she would be allowed to stay on in the job.

Speculation that she might remain was fueled by Obama's selection of Tom Daschle to as HHS Secretary. Daschle, the former Senate Democratic leader, is from South Dakota — like Gerberding. Last month, she issued a statement to the press praising Daschle and his "tradition of finding practical solutions to very tough problems."

But Friday's e-mail confirms she will indeed be leaving office, a CDC spokesman said.

"As part of the transition process, the Administration requested resignation letters from a number of senior-level officials, including Dr. Julie Gerberding. This week, the Administration accepted Dr. Gerberding's resignation, effective January 20," CDC spokesman Glen Nowak said in a prepared statement.

Nowak said Gerberding was traveling in Africa on CDC business and unavailable for comment.

The CDC investigates disease outbreaks, researches the cause and prevalence of health problems, and promotes illness prevention efforts.

Gerberding is head of the CDC and its sister agency, the Agency for Toxic Substances and Disease Registry. The two have a budget of about $8.8 billion and more than 14,000 full-time, part-time and contract employees.

Gerberding receives a total compensation of $202,200.

The memo announcing Gerberding's resignation was signed by Rich McKeown, chief of staff for outgoing U.S. Health and Human Services Secretary Mike Leavitt. It said William Gimson, the CDC's chief operating officer, will step in as interim director as of the 20th.

Daschle has not announced a choice for a new CDC director.

Gerberding was named CDC Director in July 2002. She was a relative newcomer to the agency; she had only joined in 1998 to head the agency's patient safety initiative in the CDC's Division of Healthcare Quality Promotion.

She had become prominent in the fall of late 2001. In a post with the CDC's National Center for Infectious Diseases at the time, she emerged as a leading spokeswoman for the agency during the anthrax crisis in which letters containing a deadly, anthrax powder were sent to some politicians and journalists and perhaps others. Five people died in a wave of attacks that panicked a nation already shaken by the 9/11 airplane attacks.

The CDC Director at the time was Dr. Jeffrey Koplan, who had been appointed by President Bill Clinton. He had a prickly relationship with Bush administration officials. Koplan resigned in March 2002, saying it was time to move on.

Gerberding was selected by Tommy Thompson, the U.S. Secretary of Health and Human Services, who was impressed by her performance during the anthrax crisis. She entered office pledging to work closely with the Bush administration.

She was the agency's first female director, a status highlighted in several ways, including a profile in Vogue magazine that featured a full-page color photograph of her in a gray Chanel suit and white Marc Jacobs high-heeled shoes.

Gerberding was a highly visible spokeswoman for the government on public health matters, eclipsing officials like the Surgeon General and the director of the National Institutes of Health in visibility.

That was due in part to the scary, urgent nature of topics her agency dealt with, including SARS, food poisoning outbreaks and the threat of a deadly new type of pandemic flu.

But her tenure also proved controversial.

She instituted a large, morale-damaging re-organization of the agency that triggered an exodus of admired agency scientists.

The agency was criticized for being slow to respond to Hurricane Katrina and, later, to survivors' complaints about formaldehyde fumes in trailers that had been provided by the government.

And in 2007, she was criticized for going along with the White House's editing of her Senate testimony on the impact of climate change on health, which involved deletion of key portions citing diseases that could flourish in a warmer climate.

7 Olmsted on Autism: Autism Explosion Followed Big Change in MMR Shot
Age of Autism

By Dan Olmsted

In 1990, Merck & Co., manufacturer of the mumps-measles-rubella vaccine known as the MMR, made a significant but little-noticed change: It quadrupled the amount of mumps virus in the combination shot, from 5,000 to 20,000 units. Then in 2007 it reversed course, reducing the amount to 12,500 units. Neither the measles nor the rubella (German measles) component of the MMR was changed at all -- each remained at 1,000 units throughout.

Merck also makes the single-component mumps shot, and in 1990 it also increased the potency of that shot by the same amount, from 5,000 to 20,000 units. But unlike the MMR shot, the standalone mumps shot’s potency was not scaled back in 2007. It remains at 20,000 units.

These changes were mentioned in passing recently during an informal conversation with a Merck scientist. I started looking for an explanation for the sequence of events, but Merck did not respond to a detailed written request for comment.

Absent such an explanation, simple logic dictates the reduction had something to do with the MMR in particular rather than the mumps vaccine in isolation. But what? And what about the timing -- the increase in 1990 and the decrease in 2007?

The huge rise in autism cases began about the time the mumps component in the MMR was raised in 1990. One theory, dismissed by Merck and federal public health officials, is that viral interference between the components in the MMR could create a persistent sub-clinical measles infection in a subset of vulnerable children; and because the measles virus can cause brain damage, that could lead to autism.

A study released last week by the M.I.N.D. Institute at UC Davis reported that most of the fivefold increase in full-syndrome autism -- from 9 in 10,000 children in 1990 to 44 in 10,000 children in 2000-- is real and cannot be accounted for by broader categories or diagnostic substitution. And from 1990 to 2007, the mumps portion of the MMR was higher by roughly the same amount -- quadruple.

Merck’s decision to cut back on the increase in the mumps vaccine also is surrounded by interesting timing. The cutback, in 2007, came at the same time Merck announced it was suspending its recently introduced, much-hyped four-in-one shot, ProQuad -- the MMR with the chickenpox vaccine added to it. In suspending ProQuad, Merck cited a shortage of chickenpox vaccine; subsequently, a study showed ProQuad caused twice as many fever-induced seizures as separate MMR and chickenpox shots given at the same time, and a CDC advisory committee withdrew its preferential recommendation of the vaccine. Merck won't say when ProQuad will return to the market.

An investigation I conducted while at UPI in 2006 found two cases of regressive autism in one small city -- Olympia, Wash. -- in clinical trials leading up to approval of the vaccine. Merck said the parents originally failed to report those cases to it (though the pediatricians paid to conduct the studies for Merck certainly knew about them and would have been expected to report them); the company alerted the FDA only after my inquiry.

The Merck scientist I spoke with recently also acknowledged that viral interference can affect the potency of individual MMR ingredients; that explains why the company added a whopping dose of chickenpox vaccine to the ProQuad shot, several times more than the standalone chickenpox vaccine contains. Using the same amount of chickenpox vaccine in the MMR shot as the standalone vaccine simply wouldn’t have protected children against the disease, because more virus was needed to offset the interference from the other components.

A significant number of parents of children with regressive autism cite the MMR as the proximate cause -- they say their child was developing normally until the shot, then in many cases had a serious physical reaction within a short period of time and began losing developmental milestone and showing typical signs of the disorder. Some also developed severe gastrointestinal problems, an ailment first described in cases of regressive autism following the MMR shot by Dr. Andrew Wakefield in Britain in 1998; he named it autistic enterocolitis and found measles RNA in the children's GI tract, suggesting persistent infection.

In looking at whether the increase in mumps potency in 1990 could buttress this theory of the autism epidemic, two questions arise: Is there evidence that increasing the mumps portion of the MMR could have any impact on measles infectivity or create symptoms consistent with those described by Wakefield and parents? And, could ProQuad's higher rate of measles rash and fever-induced seizures be a warning sign that something is amiss with the MMR itself, especially beginning in 1990 when Merck tinkered with the proportions of the components?

The answers seem to be, yes and yes.

In the real world, children rarely get two viral illnesses at once -- for instance, chickenpox and rubella. But when they do, viruses tend to interact -- or interfere -- with each other in unpredictable and synergistic ways. One example: Studies in the UK and Iceland showed that when mumps AND measles epidemics hit these populations in the same year, the risk of inflammatory bowel disease spiked. That's an epidemiological argument for immune interference, and a striking fit with the observations by Wakefield, and thousand of parents, that a similar condition occurs in many children with regressive autism after they get the measles-mumps-rubella shot.

A related finding comes from a study funded by Merck. In 2005, the study reported that the four-in-one ProQuad shot -- the MMR and chickenpox -- was "generally well tolerated" and had a safety profile similar to the MMR and the chickenpox shot (also made by Merck and called Varivax) when given separately.

But there were a couple of interesting differences. First, "Measles-like rash and fever during days 5-12 were more common after the first dose of MMRV [ProQuad]" than after the MMR and Varivax given separately. The difference was substantial -- 5.9 percent who got the MMRV had the rash and 27.7 percent had fever, compared to 1.9 percent with rash and 18.7 fever after getting separate shots. While that did not alarm the researchers, it could be a foreshadowing of the doubled rate of fever-induced seizures that was spotted after ProQuad was approved.

Second, even though the new element in ProQuad was the chickenpox portion, something new and unexpected was also going on with the mumps and measles components. "Geometric mean titers to measles and mumps were significantly higher after 1 dose of MMRV than after administration" of MMR and Varivax separately, according to the study's summary. Later, the authors state: "This suggests that the measles and mumps virus replication is greater after MMRV than it is" after the MMR and Varivax given separately.

In non-scientific language, it looks like the addition of another live virus -- chickenpox -- potentiated the measles and mumps components: It kicked both viruses into higher gear and they replicated at rates higher than in the MMR. At the same time, the researchers observed a greater incidence of measles-like rash, and fever, in those who got ProQuad. Were the increased measles and mumps viruses interacting in some unexpected and potentially dangerous way?

Then, for whatever reason, sometime between February and December of last year Merck reduced the mumps component of the MMR from 20,000 units to 12,500 while leaving the standalone mumps shot as it was. During that same period, it decided to suspend production of ProQuad. In April 2007, it announced the suspension, and said no more would be available after July. Then in early 2008, Merck’s study showing the doubled risk of seizures in ProQuad was unveiled and the CDC withdrew its recommendation.

And just last month, Merck said it would stop making the individual MMR component shots including, of course, the mumps shot. That leaves the MMR as the only vaccine in town, and it means there will no longer be a mumps vaccine formulation on the market with the dose the MMR contained from 1990 to 2007.

None of this might matter if not for the fact that measles is capable of causing cause catastrophic brain damage and death; that's an argument for the measles vaccine. In medical parlance, it’s a neurotoxic virus.

"The invasion of the CNS [central nervous system] by MV [measles virus] is apparently not an uncommon event, as reflected by the finding of genomic sequences in normal autopsy cases and the widespread distribution of MV in in neurons, glial cells and vascular endothelial cells of the diseased brain," according to "Measles Virus Infections of the Central Nervous System" by Uwe G. Liebert of the University of Leipzeig, Germany, published in Intervirology in 1997. "The susceptibility of the host as well as his age and immune status at the time of infection constitutes significant factors for disease progression."

Merck acknowledges the three viruses can indeed interact to affect a child’s immune system, although in ways it says are not harmful.

A Merck scientist publicly discussed the interference issue at a CDC meeting in 2004, the year before ProQuad was approved, according to agency minutes. Dr. Florian Schodel "confirmed the possibility that the chickenpox virus component of ProQuad was causing a local immune suppression and an increase in measles virus replication. ... The current hypothesis is that the varicella and measles virus are co-infecting the same or proximate areas of the body and engaging in a specific interaction, but how that works is as yet unknown.

"He said the interference appeared to involve only the chickenpox and measles viruses – 'there is no such effect for the mumps or rubella vaccines administered locally at the same time.'"

Yet based on Merck's own 2005 study cited above, ProQuad triggers an increase in mumps virus replication, too. Live viruses in ProQuad seem to be behaving in ways "as yet unknown" that cause immune suppression, co-infection, interaction and increased replication. Even without ProQuad on the market, interaction between the MMR components and the chickenpox virus remains a possibility. The CDC started recommending the chickenpox shot in the mid-1990s at the same 12-month well-baby visit as the MMR.

That suggests the pattern highlighted by ProQuad could be at work through the increased mumps component of the MMR and the addition of chickenpox to the childhood immunization schedule in the mid-1990s. The lesson could be that combining live viruses, and then increasing them or adding new ones, is inherently dangerous, especially when invasion of the brain by one of them “is not an uncommon event.”

As Andy Wakefield told me when I was working on the series in Olympia describing the children in the ProQuad clinical trials who became ill after the vaccination and subsequently regressed into autism: "It's actually heartbreaking, listening to these parents, for more than just the immediate reasons their child has met this fate. It's that you're staring into an abyss," Wakefield said. "You're listening to stories which reflect the fundamental misconception of vaccine manufacturers of what viruses are and what they do."

Two additional points worth noting: After the increase in 1990 and decrease in 2007, there is still more than twice as much mumps virus in the MMR as there was in 1990.

The changes in the mumps virus component of the MMR serves as a potent reminder of something else: MMR is not one thing but three different exposures. And over the period 1980-2009 the MMR has changed significantly at least twice, making epidemiological studies even more difficult to interpret.
Dan Olmsted is Editor of Age of Autism.

8 Dr. Paul Offit: Fox in a Henhouse, the ACIP Years (1998-2003)
Age of Autism

By J.B. Handley

"The screaming started four hours after 8-month-old Chaise Irons received a vaccination against rotavirus, recommended in June 1998 by the Centers for Disease Control and Prevention for every infant to prevent serious diarrhea. Within a day he was vomiting and eliminating blood. Doctors performed emergency surgery, saving him by repairing his intestines, which were folding in on one another. A doctor later figured out the vaccine caused Chaise's problem. In October 1999, after 15 reports of such incidents, the CDC withdrew its recommendation for the vaccination -- not because of the problem, the agency claims, but because bad publicity might give vaccines in general a bad name. But a four-month investigation by United Press International found a pattern of serious problems linked to vaccines recommended by the CDC -- and a web of close ties between the agency and the companies that make vaccines."

- Mark Benjamin, United Press International, UPI Investigates: The Vaccine Conflict

There are few parents of young children today who remember the disastrous introduction of the first Rotavirus vaccine in June, 1998 and its withdrawal from the market due to adverse events only 13 months later. Of course, the parents of children who experienced severe bowel intussusception, like the child described in UPI's investigative piece quoted above, remember it all too well.

The Rotashield introduction and withdrawal was such a fiasco it triggered a Congressional investigation, and a blistering report from the Committee on Government Reform which was released on August 21, 2000 and titled, Conflicts in Vaccine Policy (HERE).

And who would you guess was at the center of the Congressional report's criticism? You guessed it: Dr. Paul Offit.

People often ask me how the Centers for Disease Control (CDC) went from recommending 10 vaccines for children in the mid-1980s to the bursting-at-the-seams 36 vaccine schedule of today. My answer, which always surprises people, is a four-letter acronym: ACIP.

ACIP? Most people have never heard of it, the Advisory Committee on Immunization Practices. Locked away inside a single page on the CDC website, the ACIP is described as:

"15 experts in fields associated with immunization who have been selected by the Secretary of the U.S. Department of Health and Human Services to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the Centers for Disease Control and Prevention (CDC) on the control of vaccine-preventable diseases. The Committee develops written recommendations for the routine administration of vaccines to children and adults in the civilian population; recommendations include age for vaccine administration number of doses and dosing interval, and precautions and contraindications. The ACIP is the only entity in the federal government that makes such recommendations. [emphasis added]."

The ACIP is a remarkably powerful committee of appointees. Let's say you're Merck, a giant pharmaceutical company with vaccines as a primary business line. And, let's say you have invested several hundred million dollars in developing a vaccine. Just for fun, let's imagine the vaccine you have developed is for Rotavirus. Let's say you would like to sell your vaccine to as many people as possible.

Well, if you're Merck, and if you want to sell your new Rotavirus to as many people as possible, you can pass through one door and one door only: the ACIP. If the ACIP approves your vaccine, you can write your ticket. If the ACIP denies your vaccine? Zero. As Congress' report notes:

"The recommendation [by the ACIP] for routine use of a vaccine is tantamount to a Federal mandate for vaccine use."

It's almost hard to comprehend the amount of pressure pharma would be under to "manage" the ACIP and give their vaccines the best possible chance for approval – there are literally billions of dollars at stake for a single vaccine.

Enter Dr. Paul Offit. With Merck's funding and support, he filed a patent for a Merck-sponsored Rotavirus vaccine on December 9, 1994. Four years later, as his own vaccine was going through trials and no Rotavirus vaccines were YET on the U.S. vaccine schedule, Offit was appointed to the ACIP as a voting member of the committee.

Of course, Offit was well aware that a competing vaccine for Rotavirus made by Wyeth was years ahead of his own vaccine and preparing for a presentation to the ACIP in the near future. In fact, he joined the ACIP only three weeks before the committee voted to approve Wyeth's Rotashield vaccine for the Vaccines for Children program (Offit voted "yes."). What's so bad about voting for another company's vaccine for Rotavirus vaccine when you are developing a competing product? Congress explains:

"Members of the ACIP are allowed to vote on a recommendation for one company's
vaccine even if they have financial ties to a competing firm developing a similar vaccine.
For example, in the case of the rotavirus vaccine, the vaccine before the advisory committee was developed by Wyeth-Lederle. However, Merck and SmithKline29 Beecham had rotavirus vaccines under development. A recommendation for Wyeth- Lederle's vaccine would help pave the way for future recommendations for the products of Merck and SmithKline-Beecham. While ACIP members with ties to Wyeth-Lederle were not allowed to vote on recommendations for the rotavirus vaccine, those with ties to Merck and SmithKline-Beecham were allowed to vote.

This stands in stark contrast to the policies of the FDA. In discussions with FDA staff on this specific issue they informed the Committee staff that when the VRBPAC is deliberating the licensure of a vaccine, a company is considered affected [an affected company is one with a direct interest] if they are direct competitors of the manufacturer of the vaccine being considered. They further clarified that that this policy was in place because of the competing interest of the affected company and not because of concerns about the release of proprietary information."

Dr. Paul Offit joined the ACIP three weeks before they voted on a Rotavirus vaccine manufactured by Wyeth to be added to the vaccine schedule. He held a patent on a competing vaccine.

It's almost incomprehensible, and certainly shows the worst of how pharma games the US Vaccine system. It's hard to believe, but this story actually gets worse.

As we know from above, this initial vaccine that Paul Offit voted to approve was pulled from the market one short year later because of the level of adverse events affecting children. From the report:

"A product was placed on the market that had to be withdrawn within one year because it was injuring the children it was meant to protect."

Perhaps worse, and even more shocking, was the timing of the ACIP vote to approve Rotashield:

"A particularly troubling aspect of the deliberations on the 'RotaShield' vaccine is the sequence of events. The ACIP Committee voted to recommend universal vaccinations of infants before the FDA licensure of the vaccine. Officials of the CDC acknowledged that they knew of no other instance where this has happened."

Wait a minute. They approved the vaccine for universal use in kids before the FDA licensed the product? Why, that stands in rather marked contrast to the reassuring words of Dr. Renee Jenkins, President of the American Academy of Pediatrics:

"The vaccine schedule undergoes vigorous scientific and evidence-based review each year…The vaccine schedule has evolved over the past 50 years based on scientific evidence."

It appears Paul Offit joined the ACIP to ensure he could influence the approval of the Rotavirus vaccine, from which he would later benefit greatly when his own version of rotavirus vaccine was approved. Not surprisingly, Paul Offit voted yes on every action he could relating to the approval of Wyeth's vaccine. But, when the vaccine was being pulled from the market, Offit abstained:

"Dr. Offit began his tenure on ACIP in October of 1998. Out of four votes pertaining to the ACIP's rotavirus statement, he voted yes three times, including voting for the inclusion of the rotavirus vaccine in the VFC program. Dr. Offit abstained from voting on the ACIP's rescission of the recommendation of the rotavirus vaccine for routine use. He stated at the meeting, 'I'm not conflicted with Wyeth, but because I consult with Merck on the development of rotavirus vaccine, I would still prefer to abstain because it creates a perception of conflict.'"

Approve it? "Yes." Approve it? "Hell yes!" Approve it? "Absolutely." It's hurting a bunch of kids, we need to pull it! "Umm….I have a conflict, gotta go."


On February 23, 2006 the ACIP voted to add Paul Offit's vaccine, Rotateq, to the U.S. Immunization schedule. As we all know, Dr. Offit has conceded this vaccine "made him rich." An analyst for Merck notes, "At a cost of $187.50 for the three-dose series, RotaTeq is one of the most expensive vaccines to date; by 2009, the company forecasts that the vaccine could bring in as much as $500 million in annual revenue."

In May 2008, it was reported that, "Later in 2007, the Centers for Disease Control and Prevention reported that there were 117 confirmed cases of intussusception among recipients of Rotateq between March 2006 and June 2007."

Also, in 2008 it was reported that, "The U.S. Food and Drug Administration approved an update to the product label for Merck & Co.'s Rotateq vaccine to include the report of a death of a recipient due to an intestinal obstruction."
In 2008, Medical Science Monitor published a study critical of Paul Offit's vaccine (HERE).

It stated: "This study found that, after a significant decline in intussusception adverse events entered into VAERS after the withdrawal of RotaShield, the previous rotavirus vaccine, a significant, rapid increase in intussusception adverse-event reports was observed after the licensing of RotaTeq, the current rotavirus vaccine, on February 3, 2006… From February 3, 2006 through July 31, 2007, a total of 160 (of the 165 reported) intussusception and 11 (of the 16 reported) Kawasaki disease adverse event reports were identified when RotaTeq was administered or co-administered with other vaccines. Time-trend analyses showed that there were significant increases in the total number of intussusception and Kawasaki disease adverse events entered into VAERS in comparison to previous years."

And the study concluded:

"Based on the preceding realities, it would seem that the ACIP recommendations for the universal use of RotaTeq were, at best, premature and unwarranted. It is important that healthcare providers continue to report adverse events that occur following RotaTeq vaccine so that more information may be gleaned about its safety profi le, and those patients that may have experienced an adverse effect of RotaTeq vaccination should be advised that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program (NVICP).

The acceptance of RotaTeq vaccination for the US market may be significantly limited by its apparent lack of economic savings, and given the fact that it may alter disease patterns of intussusception/ Kawasaki disease, so that they occur with greater frequency among segments of the population that previously had only limited experience with such conditions. Moreover, if the serious adverse events being reported following vaccination with RotaTeq are indeed vaccine related, then, like the previous rotavirus RotaShield, RotaTeq should be immediately withdrawn from the US market."

As of January 2009, Rotateq remains on the market.

J.B. Handley is co-founder of Generation Rescue and a contributor to Age of Autism.

9 Pediatrician slams vaccine book
Los Angeles Times

December 30, 2008

A report published Monday in the journal Pediatrics charges the author of a popular book for parents on childhood vaccines with stoking fears about vaccine safety and misrepresenting the science behind the nation's immunization policy. "The Vaccine Book: Making the Right Decision for Your Child" was published last year by Dr. Robert Sears, son of the well-known Capistrano Beach pediatrician and author William Sears.

In a scathing critique not often seen in a pediatric journal, vaccine expert Paul A. Offit and coauthor Charlotte A. Moser say the book misrepresents science; supports delaying, withholding or spacing out vaccines; endorses the concept of natural immunity through such methods as chickenpox parties; does not distinguish between solid science and poorly conducted studies; and commits several errors of fact. "In an effort to protect children from harm, Sears' book will likely put more in harm's way," Offit and Moser write.

"He [Sears] believes that parents' fears should be indulged by offering alternative schedules, not countered by scientific studies, and he fails to explain that good science is the only way to determine whether a vaccine causes a particular adverse event. Instead, Sears alludes to evidence on both sides of any issue, failing to distinguish studies on the basis of their quality, internal consistency, or reproducibility and failing to distinguish those that are accepted by the scientific community from those that are not."

Sears issued a response in which he expresses surprise at the vitriol and says his position on childhood vaccination does not differ significantly from the American Academy of Pediatrics. Sears says he erred in the book by not distinguishing between good vaccine studies and poor ones but calls the Pediatrics paper "riddled with selective, misleading, and inaccurate quotes."

The biggest point of contention between the two papers, which can be found on their respective websites, Pediatrics and TheVaccineBook, is whether it's reasonable for parents who are worried about their individual child's safety to postpone or skip some vaccines. Offit and Moser call this strategy an invitation to more community outbreaks of measles, pertussis and mumps. But Sears defends the idea.

"Where my alternative schedule comes into play is for those parents who are still unsure about vaccines but they do want to fully vaccinate. I offer them an optional schedule that gets their child full vaccinated, but at a slower pace. It doesn't delay any of the most important shots."

Some of the arguments between the two papers are trivial, but the fundamental disagreement is not. The nation's public health policy depends on widespread support for childhood vaccination. However, a growing number of parents are apparently uncomfortable with having their children receive so many vaccines in a short amount of time. Their reticence to adhere to the recommended schedule may launch a return to the days when children were left immobile from polio or brain-damaged or dead from meningitis. Hopefully, the value of the nation's childhood vaccine program will come into full focus for everyone before then.

-- Shari Roan

10 Top Federal Autism Panel Votes For Millions in Vaccine Research
David Kirby on The Huffington Post

The Inter-Agency Autism Coordinating Committee (IACC) has voted to recommend earmarking millions of dollars in research funds from the Combating Autism Act of 2006 to study the possible role of vaccines in the causation of autism.

The panel also proposed spending an additional $75 million to study a wide variety of other environmental factors in autism, possibly including parental age, infections, heavy metals, neurotoxins, occupational exposures and "other biological agents."

The decision, made last month, received little or no attention in the media. The vaccine research provisions are now included in the official IACC Draft Strategic Plan for Autism Spectrum Research.

The IACC has 12 members from various health-related branches of the Federal Government, plus six "Public Members," including representatives from Autism Speaks, the Autism Society of America and the Coalition for Safe Minds, as well as Stephen Shore, an adult on the autism spectrum.

Section III of the Strategic Plan is titled, "WHAT CAUSED THIS TO HAPPEN AND CAN THIS BE PREVENTED?" The section is divided into various parts, including short- and long-term research objectives. Much of the section is devoted to studying the interactions of genetic susceptibilities with potential environmental triggers, including vaccines.

In fact, two vaccine-autism studies have been approved by the IACC, which has proposed spending $16 million to:

1) "Study the effect of vaccines, vaccine components, and multiple vaccine administration in autism causation and severity through a variety of approaches, including cell and animal studies, and understand whether and how certain subpopulations in humans may be more susceptible to adverse effects of vaccines by 2011. Proposed costs: $6,000,000

2) Determine the feasibility and design an epidemiological study to determine if the health outcomes, including ASD, among various populations with vaccinated, unvaccinated, and alternatively vaccinated groups by 2011. Proposed costs: $10,000,000

Additionally, under "Research Opportunities," the panel also endorsed this objective:

"Monitor the scientific literature regarding possible associations of vaccines and other environmental factors (e.g., ultrasound, pesticides, pollutants) with ASD to identify emerging opportunities for research and indicated studies."

For proponents of vaccine-autism research, this is a resounding victory. It covers much of what these advocates have been supporting for a number of years. It is also sure to enrage those who are opposed to such research.

But for now, it has been recommended that the US Federal Government spend millions of dollars to study not just thimerosal, (a mercury based vaccine preservative), not just the triple live virus MMR vaccine, but vaccines in general, all ingredients that go into vaccines and, most surprisingly, the effect of "multiple vaccine administration" in the causation of autism.

This document also marks the closest we have come, perhaps, to conducting a study of health outcomes among vaccinated vs. unvaccinated children in the United States. With a price tag of $10 million just to study its feasibility and to design a study, such a project would indeed be costly and cumbersome. But, as CDC Director Dr. Julie Gerberding has said, this is a study that "should and could be done." (There is a bill pending in Congress right now that would provide funding for a vaccinated-unvaccinated study).

But vaccines, of course, are not the only candidates for study in the etiology of autism. There is a growing consensus now that most autism cases arise from an unknown combination of environmental agents, probably interacting with certain genetic predispositions.

The IACC Strategic Plan contains an impressive array of objectives and ideas on studying possible environmental factors. Not surprisingly, there was significant dissention on whether vaccines should still be considered among the list. On this thorny subject, the Strategic Plan says the following:

"Research on environmental risk factors is also underway. An Institute of Medicine workshop held in 2007 summarized what is known and what is needed in this field (Institute of Medicine of the National Academies, 2007). Numerous epidemiological studies have found no relationship between ASD and vaccines containing the mercury based preservative, thimerosal (Immunization Safety Review Committee, 2004). These data, as well as subsequent research, indicate that the link between autism and vaccines is unsupported by the research literature. Some do not agree and remain concerned that ASD is linked or caused by vaccination through exposure to Measles Mumps Rubella (MMR), imposing challenges to a weakened immune system, or possibly due to mitochondrial disorder.

Public comment to the Committee reflected opposing views on vaccines as a potential environmental cause. Some contend that cumulative research on this topic indicates no role of vaccines in autism. Others contend that definitive research has not been done. A third view argues that the persistent focus on vaccines and other possible causes is misplaced.

In addition, a number of other environmental agents are being explored through research that are known or suspected to influence early development of the brain and nervous system. Recent studies suggest factors such as parental age, exposure to infections, toxins, and other biological agents may confer environmental risk. These findings require further investigation and testing."

Meanwhile, on the critical subject of interactions between genes and the environment, the panel says this:

"Although most scientists believe that risk factors for ASD are both genetic and environmental, there is considerable debate about whether potential environmental causes, genetic precursors, or interactions between genes and environmental factors should be the highest priority for research aimed at identifying the causes of ASD.
To date, few studies have ruled in or ruled out specific environmental factors. While there are reports of associations of ASD with exposure to medications or toxicants prenatally, and to infections after birth, it is still not known whether any specific factor is necessary or sufficient to cause ASD. Similar to other disease areas, advancing research on the potential role of environmental factors requires resources and the attraction of scientific expertise. Bringing this to bear on autism will help focus the environmental factors to study, as well as the best approach for staging studies to examine environmental factors, interaction between factors, and between individual susceptibility and various environmental factors."

The panel also weighed in on the possibility that "de novo," or spontaneous changes in gene structure - perhaps triggered by environmental factors - may be a factor in the causation of autism:

"(Recent) findings have contributed to new hypotheses about the inheritance of ASD. In families with just one affected member, spontaneous deletions and duplications may be causal factors of ASD. However, what causes these spontaneous deletions and duplications is not clear and possibly could be due to environmental exposures."

It also voted to recommend the following studies of environmental factors in autism, for which it proposed a budget of more than $75 million:

1) "Initiate efforts to expand existing large case-control and other studies to enhance capabilities for targeted gene - environment research by 2011."

2) "Initiate studies on at least five environmental factors identified in the recommendations from the 2007 IOM report "Autism and the Environment: Challenges and Opportunities for Research" as potential causes of ASD by 2010."

3) "Determine the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and early postnatal period of development by 2015."

4) "Conduct a multi-site study of the subsequent pregnancies of 1000 women with a child with ASD to assess the impact of environmental factors in a period most relevant to the progression of ASD by 2014."

5) "Support ancillary studies within one or more large-scale, population-based surveillance and epidemiological studies, including U.S. populations, to collect nested, case-control data on environmental factors during preconception, and during prenatal and early postnatal development, as well as genetic data, that could be pooled (as needed), to analyze targets for potential gene/environment interactions by 2015.

Some people may object to even this moderate sum of federal research money going into possible environmental factors. After all, the 2007 IOM Report from which the "five environmental factors" to study will be chosen, includes the following suggested areas of inquiry:

Heavy metals and cosmetics

RhoGAM exposure (Rho-D immune-globulin, which contained thimerosal until 2003)

"Major priority" pollutants

Toxins from industrial disasters

Prenatal exposures to infectious diseases

Occupational exposures

People who would object to studying these factors, it should be noted, are a tiny minority and a dying breed.

Far more controversial will be the inclusion of any vaccine wording within the research matrix, even though Members of Congress made it clear in the Colloquy* and Report Language of the Combating Autism Act that vaccines and other environmental factors should be studied. But the dissenting voices are coming through loud and clear in the following proposed (but not yet finalized) passage:

"Those who are convinced by current data that vaccines do not play a causal role in autism argue against using a large proportion of limited autism research funding toward vaccine studies when many other scientific avenues remain to be explored. At the same time, those who believe that prior studies of the possible role of vaccines in ASD have been insufficient argue that investigation of a possible vaccine/ASD link should be a high priority for research (e.g., a large-scale study comparing vaccinated and unvaccinated groups). A third view urges shifting focus away from vaccines and onto much-needed attention toward the development of effective treatments, services and supports for those with ASD."

Of course, it remains to be seen if these vaccine studies survive into the final version of the IACC Strategic Plan. And even if they do, that does not guarantee they will be fully implemented.

But one thing seems pretty clear, as we head into the last year of the century's first decade: Much to the chagrin of many, the vaccine-autism debate is anything but over.

*NOTE: In the Senate Colloquy, Sen. Mike Enzi, who was Chairman of the Committee (H.E.L.P.) that developed the bill, said this: "I want to be clear that, for the purposes of biomedical research, no research avenue should be eliminated, including biomedical research examining potential links between vaccines, vaccine components, and autism spectrum disorder. Thus, I hope that the National Institutes of Health will consider broad research avenues into this critical area. No stone should remain unturned in trying to learn more about this baffling disorder, especially given how little we know.

Meanwhile, Co-Sponsors Santorum and Kennedy agreed with Enzi's statement, and Senator Chris Dodd added this: Through the Combating Autism Act, all biomedical research opportunities on ASD can be pursued, and they include environmental research examining potential links between vaccines, vaccine components and ASD."

11 What is Paul Offit's Problem?
Age of Autism

By Anne Dachel

I had to ask myself why Dr. Paul Offit, nationally-known vaccine expert, would consider The Vaccine Book, by Dr. Robert Sears to be so dangerous that he'd put out a whole piece about it in the January 2009 issue of Pediatrics. It's especially curious, since Sears' book came out well over a year ago.

Offit's article, The Problem With Dr Bob's Alternative Vaccine Schedule, (HERE) led to a response from Dr. Sears (HERE) that is running on his website. I hope readers will take the time to read both pieces to understand first-hand what was said by each of the doctors.

Offit's overall message is that Sears is fueling fears over vaccine safety by allowing parents to choose alternative vaccine schedules for their children. Offit wrote, "Sears' book is unique. Unlike typical antivaccine books, he offers a middle ground, allowing parents to act on their fears without completely abandoning vaccines. Unfortunately, Sears sounds many anti-vaccine messages." Offit devoted the Pediatrics article to describing the ways in which Sears' book is undermining the vaccine program and endangering children's health.

In his response, Sears stated, "I believe that Dr. Offit has misconstrued the book's overall message by selectively extracting various phrases and sentences that discuss anti-vaccine ideas and worries parents have and portraying those ideas as my own." In another place he said, "I believe that Dr. Offit has greatly misrepresented the overall message of the book as being 'anti-vaccine."

I read through many of the things Sears has written and looked hard for his "anti-vaccine messages." I have to agree with him when he says he's clearly not attacking the vaccine program. Sears stated, "It is my belief that many families go unvaccinated simply because they aren't offered a more gradual option." Sears doesn't enter the controversy siding with parents. For example, he cited the studies that debunk a link between the MMR and autism, and added that "My initial worries about the MMR and intestinal inflammation are probably unfounded."

Sears has called for studies on the effects of aluminum, noting, "I've been searching and searching for human infant studies that determine what a safe level of injected aluminum is, including looking at all the studies used in the article quoted by Dr. Offit, and I can't find a single one."

Sears avoids the argument over mercury in vaccines and autism by saying, "It has been removed from virtually all vaccines, so you really don't have to spend hours researching whether or not it is harmful."

I couldn't find big issues of controversy in what Dr. Sears has written about vaccines. He said in his response, "If my book had been portrayed correctly , we would find very little to debate about." Sears is not criticizing the CDC or vaccines in general. He's simply asking for flexibility in dealing with parents who are worried about vaccine side effects. He's definitely pro vaccine.

According to Offit, even a little break from rigid adherence to the mandated schedule is dangerous. It gives parents the idea that there might be serious side effects that could be avoided by changing the schedule. And, judging by the tens of thousands of copies of Sears' book that have been sold, lots of parents are having second thoughts about blindly accepting the one-size-fits-all-kids vaccine schedule.

Two things in Sears' response to Offit Pediatrics article got my immediate attention. Sears noted that lots of parents worry about the cozy relationship between the vaccine makers and the medical community, especially those in charge of safety. Sears wrote, "In medical school we are taught to at least briefly raise an eyebrow at research funded by a pharmaceutical company, instead of simply taking it for granted."

A bit later, Sears said, "As for the issue regarding parents' trust in the vaccine manufacturers, that trust was severely shaken when it was revealed in the Los Angeles Times on February 8, 2005, that way back in 1991 a researcher at Merck sent a memo to the president of Merck's vaccine division stating that they had just realized that the cumulative amount of mercury in vaccines given to infants by six months of age was about 87 times the safety limits set by the FDA. And that information was not revealed to the public until 8 years later." Sears said he continues to put his faith in the vaccine makers but he added that "I find it surprising that any doctors can fault a parent for not completely trusting Merck after that, or the FDA and CDC departments that were supposed to be overseeing this type of issue."

Offit doesn't worry about conflicts of interest however. In his new book, Autism False Prophets: Bad Science, Risky Medicine, and the Search for a Cure, the fact that Eli Lilly tested thimerosal on 22 adult patients who had meningitis is noted. Offit wrote, "Lilly scientists gave thimerosal to doctors to treat the infection. It didn't work." The deaths of the patients from meningitis also prevented any possibility of studying the long term side effects and it meant there was no way to determine how safe thimerosal would be for babies and children. The fact is that the manufacturer's testing was the only recorded study on thimerosal before it was used regularly in vaccines that I've ever heard about. Offit wrote, "Although thimerosal didn't treat meningitis, doctors found that it was safe. Adults injected with 2 million micrograms of thimerosal didn't suffer symptoms of mercury poisoning; the amount was 10,000 times greater than the FDA later found babies had received in vaccines." (p. 63 Autism's False Prophets)

Simpsonwood, the meeting of scientists, federal health officials, and pharmaceutical company representatives in 2000 at the Methodist Retreat Center in Norcross, GA was also talked about in Offit's book. The initial findings by Dr. Thomas Verstraeten showed a relationship between the increase in mercury-containing vaccines and developmental problems. Offit wrote, "With the exception of autism, children who had received mercury in vaccines were more likely to have a variety of neurological problems." (p. 91 AFP)

Offit continued, "Tom Verstraeten presented his data. He started with autism, concluding that the relationship between the amount of mercury in vaccines and and the risk of developing the disorder was 'not statistically significant.' ...He showed that children who had received mercury in vaccines were more likely to have tics, attention deficit disorder, and speech and language delays. ...If Verstraeten's preliminary data were right, vaccine makers public health officials, and doctors had inadvertently poisoned a generation of children." (p. 92 AFP)

Not to worry, according to Offit. By 2003, "Verstraeten had gone back to the medical records to verify the computer diagnoses,... Verstraeten found that his preliminary data had been misleading: mercury in vaccines did not cause harm. He concluded, 'No consistent significant associations were found between thimerosal-containing vaccines and neurodevelopmental outcomes.' " (p. 93 AFP)

Offit noted that many charges have been leveled against Verstraeten for his about-face over mercury's side effects, plus there's the fact that by 2003, Verstraeten had gone to work for GlaxoSmithKine. It's obvious too that Offit doesn't raise an eyebrow at connections between researchers and drug companies as Sears told us he should.

Other medical experts have also published their opinions of Offit's Pediatrics article on Dr. Sears. (HERE)

Dr. Jon Poling, father of Hannah Poling whose case in federal vaccine court gained national attention in 2008 when it was conceded that the vaccines she received were linked to her autism, also responded: "As a physician, scientist, and father of a vaccine-injured child, I have many issues with Offit and Moser's critique of Dr. Sears vaccine book, particularly its authoritarian tone and content. Offit is certainly entitled to his opinion, but it must be recognized as that. We must stick to the science and recognize the open questions with regards to vaccine safety."

Poling gave a detailed summary of the possible errors in the claim that epidemiological studies have disproved any association between vaccines and autism. He also said, "As a Neurologist that saw his normally developing daughter regress into autism before turning 2 years old, co-incident with immunization, I obviously have an inherently different bias than Offit, the wealthy vaccine inventor and patent holder."

Poling ended his letter by saying, "As physicians we took an oath to 'first do no harm' to our individual patients. Dr. Sears offers a pro-vaccine individualized approach to childhood immunization that acknowledges the risks, benefits, and uncertainties of this medical intervention. Dr. Sears should be applauded for his efforts to provide safe vaccination alternatives to his patients, given the void of randomized controlled trials to support continued growth of the current CDC/AAP schedule.

"Rather than personal attacks, let's turn to science to provide the answers. The enormous public benefit of vaccination cannot be used to stifle open discourse on critical vaccine safety issues. One size does not fit all."

Where have we heard the statement, "One size does not fit all" with regard to vaccines? It was announced on April 03, 2008 in a commentary on CNN: A view from the CDC, (HERE) "Although some may call it a "one size fits all" approach, the recommended vaccine schedule is flexible, and it does account for instances when a child should not receive a recommended vaccine or when a recommended vaccine should be delayed."

Four days later, on April 7, the phrase again appeared in an article (HERE) by Anne Schuchat MD, assistant surgeon general at the U.S. Public Health Service and director at the CDC's National Center for Immunization and Respiratory Diseases.

It was also said by a top doctor, Bernadine Healy, former head of the National Institutes of Health (HERE) on CBS News.

"Healy says the argument need not be framed in those terms (vaccinate or don't vaccinate). Instead, she says, we should vaccinate, but work to do it in the safest manner possible based on what we know and what we can find out.

"That's what the parents of autistic children have told me as well. If we can screen children to see which ones might be more susceptible to vaccine side effects, and vaccinate them on a more personalized schedule that is safer for them, why wouldn't we? If it's safer for all children to have their vaccinations spread out, why wouldn't we? Healy says it's called 'personalized medicine' and is being done in virtually all areas of medicine today with the exception of vaccines. Yet the government continues to frame the conversation in all-or-nothing, 'one-size-fits-all' terms."

Healy challenged the credibility of the CDC and admonished officials for refusing to investigate a susceptible subgroup of children who are unable to eliminate the toxins in vaccines. This admission that there hasn't been enough research and that epidemiological studies are not proof is a major step toward public recognition about what's happened to our children.

Healy said that officials have been too quick to dismiss a link between vaccines and autism without ever studying the group that got sick. There never have been studies done on the kids that developed symptoms of autism within a few weeks of being vaccinated. She furthermore pointed out that the Institute of Medicine which produced the cumulative study on vaccines and autism in 2004 refused to 'pursue susceptibility groups.' In other words, they didn't want to find any evidence that linked vaccines to autism. She left us with the haunting statement: 'The question has not been answered.'

In the December 11, 2008 issue of U.S. News and World Report, A Government Call for Vaccine Research, (HERE) Dr. Healy again called for more research into vaccine safety.

It would seem that yet another top doctor is calling for flexibility when it comes to the vaccine schedule and for additional studies on safety. Will Paul Offit be writing a scathing critique of Bernadine Healy for her very vocal challenge to the mandated vaccine program in next month's Pediatrics?

Dr. Lawrence Rosen, another well-known physician in the vaccine debate, added his letter in response to the Offit's article. Rosen practices in northern New Jersey and consults at Hackensack University Medical Center. His remarks sounded a lot like what Bob Sears had said.

Regarding parents wanting changes in the vaccine schedule, Rosen wrote, "Would it be better that they seek non pediatric primary care in support of no vaccination or would it better for me to tolerate their concerns and 'allow' them to vaccinate flexibly? What is the 'right thing' to do? This is what many of us struggle with.

"As I become more involved in the AAP at a leadership level, I become more and more aware of the divide between pediatricians. What I fear is that we as a profession and the AAP as an institution may be discouraging honest and open dialogue about one of the most important public health issues of our times. I find it highly unusual that a fellow AAP pediatrician is roundly criticized in Pediatrics (the flagship journal of the AAP) without a chance to address the claims. Perhaps some at the AAP find his book that threatening. Is fear of information the direction we want to support? Should we not be using this as an opportunity for discussion?

"Whether we want to admit it or not, public trust in the immunization program and in pediatricians in general is eroding. And while we can debate whether aluminum and mercury in vaccines is the same or different as what we eat/drink/breathe (my personal bias is that we should reduce all exposures when possible), we must all agree that the only way to save the U.S. vaccine program - and trust in our profession by the families who need us most - is to encourage public conversation in a non judgmental manner. And it has to start here, with us."

Offit's critique was also the focus of an article in U.S. News on December 29. In Flexible Approach to Vaccinations Comes Under Fire (HERE) reporter Deborah Kotz, who also spoke with Dr. Sears, described Offit's piece as "an attack on doctors who take a flexible approach to vaccinations." Kotz wrote, "Unfortunately, instead of allowing a pro-and-con debate about the benefits and drawbacks of pediatricians working with parents who wish to have some flexibility, the Pediatrics journal editors chose to feature just one side of this debate. The authors of the special article take a firm stand against allowing any deviation from the current vaccine schedule, arguing that in offering a middle ground, Sears is sending 'antivaccine messages.'

"What's worse, the lead author, Paul Offit, who heads the vaccine education center at the Children's Hospital of Philadelphia, clearly has a conflict of interest. He's one of the patent holders of RotaTeq, a vaccine against rotavirus that's on the AAP's vaccine schedule. That means he stands to lose money if parents shun RotaTeq."

Kotz said Offit's piece was "a special article that quite frankly shocked me for its one-sided treatment of a very important issue with regard to vaccinations." Kotz also wrote that Offit didn't respond to her request to be interviewed. That seems incredible to me, since Offit's name appears in articles on vaccine safety more often than any other doctor. It's hard to imagine that he'd skip an opportunity to be covered by U.S. News.

There seems to be a lot of holes in Offit's claim that the science is in on vaccines and a possible link to autism. Clearly, there is a lack of safety studies and research looking into the kids who regressed following vaccinations. Barbara Loe Fisher from the National Vaccine Information Center (HERE) has also voiced her concerns about the lack of science to back the claim of no link: "There has never been a large, prospective scientific study to scientifically evaluate the long term effect on brain and immune function of giving children in America the CDC recommended 69 doses of 16 vaccines (for girls) and 66 doses of 15 vaccines (for boys) from the day of birth to age 18, including injecting children under age six with 48 doses of 14 vaccines and administering eight or more vaccines on the same day as the CDC schedule allows. Any long term study that evaluates the safety and effectiveness of this kind of vaccination schedule should also compare the health of children, who receive all the CDC recommended vaccines on schedule, with children, who receive fewer or no vaccines at all, to evaluate the long term health differences between the children. This is the only way a true scientific comparison can be made to determine whether the recommended CDC schedule leads to better or poorer health outcomes for most children and whether there are certain groups of children, perhaps those with genetic or other biological high risk factors, for whom vaccination is much more likely to result in permanent brain and immune system dysfunction."

Dr. Sears isn't a lone maverick in his call for a flexible schedule. Another well-known pediatrician, Dr Jay Gordon, was On Larry King Live (HERE) raising serious questions about vaccine safety. On his website (HERE), he states, "I am very much opposed to the routine vaccination schedule in the U.S. There are too many vaccines given too early in a child's life and not enough information given to parents.

"Vaccines have side effects. There can be rare severe problems, common minor problems and constant speculation about hidden problems. Vaccine proponents who deny side effects are not being honest with you, either.

"My strongest recommendation to you and anyone else considering alternatives to the standard vaccine regimen is to become very well informed and discuss these issues long and hard with your doctor. A doc who won't hold these discussions is too busy and you may need to move on to another."

Offit has tried to portray parents' fears about vaccine safety as something irrational. At the beginning of his article on Sears, Offit wrote, "Many parents are hesitant about vaccinating their children. Vaccine hesitancy can be explained in part by a lack of trust in those who make vaccine recommendations; a suspicion of profit motive driven by pharmaceutical companies; misinformation on the Internet; failure to appreciate the seriousness of vaccine-preventable diseases, given their low rates; and constant stories in the media claiming that vaccines cause a variety of illnesses, ranging from allergies to autism. Most recently, with the addition of several new vaccines to the infant vaccine schedule, some parents have become concerned that children receive too many vaccines too early."

Offit leaves out a very important reason why parents are frightened over vaccines. There is an epidemic of autism out here in the real world that no one can reasonably explain. I don't care where you are, if you bring up autism, someone will start talking about a family member or neighbor with a child who is autistic. Stories are everywhere about normally developing children who regressed into autism following vaccinations. I've yet to hear a plausible explanation for why children suddenly lose learned skills like talking, making eye contact, and being potty-trained.

In Offit's world, there hasn't been any increase in autism, only greater awareness and an expanded spectrum of autism. Even though many parents, scientists and doctors directly link the autism explosion to the dramatic increase in the number of vaccines in the mandated schedule, Offit sees no connection. In Autism's False Prophets, Offit wrote, "Two phenomena likely account for the increase. First, the definition of autism has broadened to include children with milder, more subtle symptoms. During the time of Leo Kranner and Bruno Bettelheim, children with mild symptoms of autism may have been described as 'quirky' or 'different' or 'unusual' but not autistic. Today, these children are more likely to be diagnosed with autism spectrum disorder or Asperger's Syndrome or pervasive developmental delay. Second, in the past children with severe symptoms of autism were often considered mentally retarded. Today, as the number of children with severe autism has increased, the number with mental retardation has decreased." (p. 3-4 AFP)

(Strangely, Offit included statements in the book that seemed to say the opposite. On page 109, he wrote, ":Finally, in January 2008, Robert Schechter and Judy Grether from California's Department of Public Health took a closer look at the rate of autism from 1995--six years before thimerosal had been removed from vaccines--to 2007, six years after it had been removed. They found what everybody else had found: the rates of autism continued to increase." It seems that when it's convenient, the autism increase is real. When it's implicates vaccines, it isn't.)

In his book, Offit stated that, "The first clue to the cause of autism is that it's genetic." (p. 218 AFP) He talked about possible environmental triggers, but they don't include vaccines. The basis of Offit's view of autism is that children are born with the disorder and that it hasn't really increased. Everything in Offit's scenario depends on this claim, but that simply isn't what's happening in America. I don't have to go back more than a couple of days to find news stories describing the dramatic impact of autism that can't be explained with Offit's theory of an expanded spectrum.

December 31, 2008--Edmond, OK. (HERE) "Autism is a quiet epidemic growing at a rate of 10-17 percent per year, according to the U.S. Department of Education. Eighty percent of these children are under the age of 14."

January 2, 2009--Columbia, SC (HERE) "The number of students diagnosed with autism in South Carolina's public schools has more than doubled in the past five years, creating more challenges in programming and staffing for education officials. The state Department of Education counted 2,685 students in 2007, up from 1,283 students in 2003, with autism as their leading disorder."

January 2, 2009-- Maryland, Health report gives mixed results (HERE), "The number of children diagnosed with autism in the local school system more than doubled in only four years, according to the 2008 Community Health Assessment, a report released by Calvert County charities and government agencies."

January 3, 2009--Marin, CA (HERE) "The number of autistic students in Marin has doubled in the past seven years, from 76 in 2001 to 152 in 2008."

This is only part of the autism crisis. Soon the focus will be on providing for the upcoming generation of adults with autism who aren't there now. On December 16, the Chicago Tribune ran the story, Autism study: Fears for the Future (HERE) which described the dire prospects for autistic adults based on an Easter Seals study. Easter Seals looked at the situation of "adults" --individuals between 19 and 30--and found that the majority are living at home and unemployed.

Parents have very real fears about what will happen when they're no longer able to care for their children. Insurance doesn't pay for the therapy these people need and the financial burden is huge. Wendy Murphy, director of therapeutic schools for Easter Seals Metropolitan Chicago was quoted in the article: 'We are always talking about the need for adult services. We always say that there's a crisis, that there's nothing for our students to do when they graduate. There just aren't any supports out there to help people with autism live independently.'

The experts like Paul Offit who devote themselves to denying that autism is a crisis with very real environmental causes sound absurd when we read these stories. If autism has always been around like this, why isn't there even one study that could find the mislabeled autistic adults at rates even approaching what we see in our children? Offit claims that they're out there somewhere, but he never has to prove it.

It will be the autism price tag that will finally expose the truth. Each affected child represents an estimated cost of 3 to 5 million dollars for lifetime care and it'll be the taxpayers who are left with the massive bill for this disaster. The public is going to demand answers and there will be plenty of parents who will blame the vaccines their children received and the proof will be everywhere.

Paul Offit and the AAP should understand one thing: this issue isn't going to be swept away with one damning article in Pediatrics. The autism epidemic is very real and parents will continue to be scared of what vaccines may do to their children. Good doctors will be listening to them.

Anne Dachel is Media Editor of Age of Autism.

12 Why Paul Offit Isn't Flexible on Vaccines
US News & World Report

January 05, 2009 03:20 PM ET | Deborah Kotz

Last week, I blogged about an article in the Pediatrics journal written by vaccine expert Paul Offit and received a slew of heated comments both defending and attacking Offit's criticism of doctors who take a flexible approach to vaccinations. Vaccines are certainly a heated issue among parents and doctors alike: Witness the mass protests currently going on against a New Jersey law that takes effect this week mandating that preschoolers be vaccinated against the flu before they're allowed to return from winter break to their nursery school or day-care center.

Many of the commenters were concerned about Offit's conflict of interest; he is the co-inventor of the RotaTeq vaccine against rotavirus. Pediatrician Lawrence Rosen, who serves on the complementary medicine advisory board for the American Academy of Pediatrics (publisher of Pediatrics), sent me an E-mail commending me on my blog and included a letter he sent to the journal criticizing the AAP for "discouraging honest and open dialogue about one of the most important public health issues of our times" in not handling flexible vaccination as a debate that has two sides.

Others pointed out that I was too harsh in objecting to Offit's conflict of interest since his academic institution sold the rights to this vaccine so that he no longer personally profits from it. Offit, who could not be reached for comment before I posted my first blog, offered since to tell me why he's so opposed to veering off the government's recommended schedule for vaccinations.

First, he addressed the apparent conflict of interest, an issue he described as "very upsetting to me." "Yes, I'm co-inventor and co-patent holder of the rotavirus vaccine, but I didn't do it for money and I no longer make any money off of it." He added that he's not blind to the risks posed by vaccines just because he invented one. "Vaccines have side effects," he says. "The oral polio vaccine [no longer in use] can cause polio, and the acellular pertussis vaccine can cause seizures. But it could be that those children who develop severe reactions would be even more overwhelmed by a natural infection." Genetic studies are now being conducted to see if this is indeed the case.

Allergies to vaccines are the biggest problems that go unaddressed, he says. The flu vaccine, made using eggs, is unsafe for those with egg allergies, and other vaccines contain gelatin, which is allergenic. "Can we make these vaccines safer? Of course we can," he says. "But we push pharmaceutical companies to do things that don't make them safer like removing thimerosal [a preservative that contains mercury]."

Offit says there's zero scientific evidence that vaccines cause autism and that thimerosal, aluminum, and other metals found in vaccines are in such small quantities that they pose no risk to brain development. He believes there's also no reason to be concerned that vaccines are responsible for the rising rate of autoimmune disorders like asthma—although my colleague Bernadine Healy has pointed to one recent finding that delaying the DPT shot a few months cut the risk of childhood asthma pretty dramatically.

So what should a doctor do when confronted with parents who refuse to give their baby five shots against eight different diseases in a single office visit?

"That's the $64,000 question," he says. "The notion that children are receiving too many shots at once is understandable; kids today get 26 inoculations against 14 different diseases. That's a lot to ask of a population that doesn't see much of these diseases."

But, he adds, doctors can't be asked to participate in what he calls "substandard care." Instead, doctors need to spend some time convincing parents that delaying any shot will be putting their child at risk "without any proven medical benefit. What if he or she gets meningitis while you're waiting to get the shot?"

Still, I press him, what about all those yearly changes to the vaccine schedule? After all, kids weren't getting the flu vaccine up until now, and suddenly they need it because it's so lifesaving? "A kid on my son's Little League team died from the flu last year," he says. "It was my son's first funeral, and it saddens me deeply that this was for a disease that could have been prevented with a vaccine."

13 US doctors pay to hear Oregon town's vaccine views
Associated Press

By JEFF BARNARD – 4 days ago

ASHLAND, Ore. (AP) — There are so many parents in this free-spirited, unconventional small town who won't get their kids vaccinated that federal researchers are paying money just to hear their side of things. On Saturday, 80 locals will get $50 apiece to talk about their worries over the risks of childhood shots.

"One of the basic tenets of my decision-making is mistrust of the government, a mistrust of the pharmaceutical companies, and mistrust of the big blanket thing that says this is what everybody has to do," says Tracy Harding, an organic farming consultant and mother of two.

"I get the public health standpoint," she said. "I am still questioning (vaccines') safety."

Nationally, there is a budding movement of parents who are getting exemptions from laws requiring children to get vaccinated before attending school. The exemptions are one explanation the Centers for Disease Control and Prevention gives for a spike in measles cases. The government recommends as many as 10 vaccines before a child is 6, plus boosters along the way.

Dr. Ben Schwartz, an adviser to the National Vaccine Program, said the meeting in Ashland is one of three where the government is paying average citizens to give their views to inform officials charting the direction of vaccine research for the next five years. A similar meeting was held in Birmingham, Ala., and another is set for Indianapolis, both sites with more mainstream views about vaccines.

But Ashland stands apart from the mainstream.

The town of 20,000 on the flanks of the Siskiyou Mountains in southwestern Oregon has always been different. In the early 20th century it was on the Chautauqua lecture circuit, and the sulfurous waters of Lithia Springs drew visitors looking for a cure for what ailed them.

Today, it has one of the highest rates in the nation for vaccine exemptions — 28 percent and rising in kindergartens, compared with about 4 percent statewide. One alternative school has 67 percent.

A liberal outpost in a conservative region, Ashland likes to go its own way. The city has its own water and electric utilities, and was a pioneer promoting solar energy, high-speed Internet, and dog parks. It has serious debates about whether to cut down trees to expand the library or whether to allow a woman to ride her bicycle naked in the Fourth of July parade.

For years, Dr. Jim Shames, a physician who prefers a down vest to a lab coat, has argued the benefits of vaccines with Harding, his next-door neighbor.

As Jackson County's chief medical officer, Shames would like every child immunized. Ashland always has some whooping cough around, which can be devastating to babies, but has seen no spike in measles. Still, Shames fears the community is vulnerable because so many international visitors come to the Oregon Shakespeare Festival and Southern Oregon University.

Shames has been working with nursing students from Oregon Health & Science University on a pamphlet that would promote immunization.

While doing interviews for that pamphlet, nursing student Shauna Gargus, who had her own two kids vaccinated, found many parents distrust mainstream medicine. They tend to believe their friends rather than medical research. Their biggest single fear is that the shot for measles, mumps and rubella could cause their children to become autistic, despite solid scientific studies that show no evidence of that.

"The fear is real for parents, and it overshadows the research," she said. "This is my hometown. This is where I grew up. I care about the community here. I just really would like to not make this a browbeating issue."

Harding is suspicious of the need to inject so many vaccines into small children. She stopped vaccinating her son, Frank, after his first shot as a baby triggered hours of crying. Her daughter, Stella, got a tetanus shot, but that is all.

Until now, Tyre Dawn has depended on organic food and plenty of playtime outdoors to keep her 4-year-old son, Lukyan, healthy. But she is planning to open a preschool in the spring, and with so many children around, she is now rethinking her policy.

"It is essential in these times for everyone to look more closely at the choices they are making," she said.

Jennifer Margulis moved here with her husband and three kids from Massachusetts, where her mother is a cellular biologist and member of the National Academy of Sciences. Though she chuckles at some of Ashland's personality quirks, she embraces the city's strong sense of community and many people's distrust of mainstream medicine.

"I never questioned the efficacy or intelligence of doing vaccines until I was in the hospital with my newborn daughter and a doctor tried to get me to give her hepatitis B vaccine," she said. "Hepatitis B is a sexually transmitted disease. I knew I didn't have hepatitis B. I knew my husband didn't have it. I knew there was no way she would come in contact with anyone with hepatitis B.

"You have this tiny, frog-like baby and they want to shoot her up with things."

Afterward, Margulis' pediatrician supported her choice. "I decided it was my responsibility as a parent to research each and every vaccine to make an informed, intelligent decision, not to just follow what doctors told me," she said.

14 Merck Focusing on Combination Vaccine
Manufacturer Stops Sales of Monovalents for Measles, Mumps, Rubella
By David Mitchell, 12/24/2008

Merck & Co. Inc. has stopped production and sales of its monovalent vaccines for measles, mumps and rubella. The manufacturer instead plans to focus on its combination vaccine, MMRII.

Merck spokeswoman Amy Rose said MMRII accounts for 98 percent of the company's volume for measles, mumps and rubella vaccines, compared to just 2 percent from monovalent vaccines Attenuvax (measles), Mumpsvax (mumps) and Meruvax (rubella).

"The combination vaccine is what's recommended, and it's such a significant portion of the orders we see," said Rose. "It's in the best interest of public health to make more of that rather than dedicate manufacturing capacity to monovalents."

Rose said Merck had not decided when, or if, it might make the monovalent vaccines available for sale in the future.

Doug Campos-Outcalt, M.D., M.P.A., who serves as the AAFP's liaison to the CDC's Advisory Committee on Immunization Practices and is a former member of the AAFP Commission on Clinical Policies and Research, said Merck's decision was insignificant in terms of public health. He added, however, that some parents likely will be unhappy.

"The use of the single antigen is pretty limited," he said. "There's no harm if you need one in getting all three. There are some parents out there that want a delayed vaccine schedule. They want the vaccines spread out over a longer period of time and not so many at once. That's a lot of hooey. Alternative schedules have never been proven to be superior."

15 Fatherhood: Autism Roulette
Best Life

By: Ben Hewitt

To vaccinate or not to vaccinate is the parental question of our time.

The needle looked as big as a missile.

It seems unlikely it was any bigger than the hundreds of other needles stashed in our pediatrician's office, but in such close proximity to my infant son's meaty thigh, it looked menacing.

The nurse chatted away as she slipped the needle into a bottle of clear liquid and pulled back on the plunger. I could hear her talking—"How about this weather... What a sweetie... Might be a bit restless tonight... My boy just started college... It goes so fast"—but I wasn't listening. My eyes moved from the needle to my son. Finlay was curled into my wife Penny's lap, her arms wrapped around him, her long blond hair flowing around his little head and covering one sky-blue eye.

Fin was 6 months old. He was our first child. In this doctor's office in St. Johnsbury, Vermont, he was about to be vaccinated against five diseases, some of which have pretty much disappeared from America. As the needle pricked his flesh, a look of pained confusion hijacked his face. I was afraid too.

With your first kid, you are scared. You are scared he's going to choke on a grape. You are scared he's going to tumble down the stairs. You are scared his fever is going to spike to 109 and scramble his brain. You are scared he's going to catch an incurable disease and waste away before your eyes. That's why we vaccinated Fin. Fear. I'd also heard about the controversy over childhood vaccines and their purported link to autism, and that worried us as well. Like I said, we were scared.

A couple more pinpricks and we were done. Fin didn't even cry. He was scheduled for 31 more injections before his fifth birthday, as mandated by the Centers for Disease Control and Prevention's schedule.

My son didn't have an immediate reaction to his vaccinations, at least not that we could see. He wasn't restless, he didn't get a fever, his eyes didn't roll back in his head, his tongue didn't fork. I felt silly for having worried at all. In fact, Fin's development seemed to be taking the fast track. His first word—duck—came at 8 months, and by his first birthday, he was speaking in sentences. His diction was nearly perfect; there was none of the usual baby babble. Everyone understood him, and he reveled in being understood. He was gregarious and charming. Our friends started calling him Funlay.

When he was about 2 and a half, Fin's personality began to shift. At first, it wasn't dramatic, just a slow dawning that our easygoing boy wasn't so easygoing anymore. He seemed less in control of his actions and more compulsive. He did things on the fly: grabbing stuff off the counter at the general store, making me have to buy a newspaper because he'd torn through the front page. And he was becoming hypersensitive to texture and sound: At his third birthday party, he wore headphones when we sang "Happy Birthday." Even the softest cotton shirts sent him into sobbing fits: "It's too itchy! It's too itchy!" He'd tear the shirt off his little body and spend the day half-naked.

At first, we didn't even consider that Fin's behavior could be related to vaccines. But during a routine checkup, we discussed Fin's symptoms with our pediatrician, and she raised the possibility of Asperger's syndrome, a mild autism-spectrum disorder. In our alternative-health neck of the Vermont woods, it was the kind of condition many of our friends have come to blame on vaccines.

Fin's behavior met many of the criteria doctors associate with Asperger's and use to diagnose it: Lack of social or emotional reciprocity. Check. It had always puzzled us that he seemed totally unconcerned about pain or distress in others. Intensely preoccupied with only one or a few interests. Check. Fin was obsessed with making wooden bows and arrows, and he spent hours playing with them. Has a formal style of speaking that is advanced for his age. Check. The kid was constantly using words that were years, if not decades, beyond his age. One day, when he was 4, he noticed that I was yawning. "Papa," he said, "are you feeling soporific?" Heightened sensitivity to loud noises, lights, or textures. Double check.

Ultimately, we never sought, or received, an official diagnosis of Asperger's, in part because there is no "cure." Symptoms often ease as a child ages and learns to accommodate for his condition. But our primary reason was that we didn't want a label that might negatively affect the way we—and others—interacted with our son.

Asperger's falls under the umbrella of autism-spectrum disorders, a wide range of brain-development disorders that includes children who need constant supervision and support for daily activities, as well as highly functioning adults. It's estimated that there are now up to 1.5 million autistic people in America. In the early 1970s, the incidence was one in 2,500 children; today, it's one in 150, with boys four times as likely to be affected. Over this same period, the CDC has nearly quadrupled the number of childhood immunizations, from eight doses of three vaccines to 36 doses of 11 vaccines.

Fin was almost 3 when his brother, Rye, was born. Like Fin, he was a healthy baby, reared on breast milk, farm-fresh eggs, and vegetables straight from the garden. Unlike Fin, he did not receive any vaccines. Our fear of the side effects had trumped any other fears we had. We realized we were ignoring our doctor, but we felt we had no choice.

When I started reporting this story, I had a clear goal: to examine the scientific basis of the autism-vaccine link and to evaluate if I had made the right decisions. With hundreds of hours invested in research, I realized that science could take me only so far. This is also a story about trust of the medical establishment, about individual health versus public health, and about risk. I felt as if I were trying to solve a scientific riddle (investigating the veracity of research), wrapped in a medical mystery (exploring the causes of autism), inside an institutional enigma (deciphering the policies of the Centers for Disease Control and Prevention). This drama is playing out across the nation as officials consider more stringent immunization laws and as a panel of judges examines the evidence linking vaccines to autism to determine if the government's vaccine injury fund should compensate parents of children with autism. But ultimately, this was my personal voyage, just as it is for every parent.

In 1796, English doctor Edward Jenner first used the cowpox virus to protect humans against smallpox. But immunization in America didn't start in earnest until the mid-1950s, following the development of the first polio vaccine by Jonas Salk. The vaccines we give our kids today operate in the same way as these early efforts. "The key is that the immune system tends to 'remember' infectious agents," explains pediatrician Neal Halsey, a vaccine researcher at the Johns Hopkins Bloomberg School of Public Health. "If you can introduce a weakened strain of a live virus or something that mimics a virus, your immune system will respond and remember that response the next time it's attacked by that disease."

Thanks to the success of national immunization programs, diseases that once stalked our daily lives have been forced into retreat or outright surrender: Polio. Mumps. Smallpox. The CDC estimates that fully vaccinating U.S. children born this year will save 33,000 lives, prevent 14 million infections, and save $10 billion in medical costs per year. "There is little to no immediate risk of many of the diseases we vaccinate for, largely because we've eliminated them in America," says Dr. Halsey. "So the consequences of not vaccinating may not be as quick to come as they once were. A certain amount of complacency comes along with that."

The government believes the immunization program is so critical to public health that every state requires proof of vaccination before a child can enter the public school system. All states allow medical exemptions, and most permit exemptions based on religious practices. But an increasing number of nonvaccinators belong to a different group: those who object to the inoculations because of personal beliefs. Currently, 21 states allow some kind of personal exemption. In 2004, 2.54 percent of children were not vaccinated because of their parents' beliefs, a 250 percent increase over 1991, according to the Johns Hopkins Bloomberg School of Public Health. "Twenty years ago, the primary reason for not vaccinating was ignorance or apathy," says Dr. Halsey. "Now we see that some people who aren't immunizing are affluent and well educated." In other words, the Whole Foods set. Nonvaccinators also tend to be geographically clustered, Dr. Halsey told me, which creates hot spots of increased disease susceptibility.

My conversation with Dr. Halsey gave me pause. He says there is "little to no immediate risk" of disease, which I find comforting. The last case of naturally occurring polio in America struck in 1979. But public-health officials warn that outbreaks of the measles and mumps are increasing. British authorities recently announced that measles has become endemic again in the United Kingdom because of suboptimal vaccine coverage in the past decade. Still, Dr. Halsey raised an issue I'd never considered: Was our decision not to vaccinate Rye rooted in complacency? It seemed such a weak hinge for such an important decision. I don't feel complacent.

There was no specific moment we decided not to vaccinate Rye; rather, our decision was cemented over a period of perhaps six months, through debates with our doctor and other parents (some whose kids were vaccinated; some whose weren't) and during those dark hours when couples discuss their weightiest issues. Our primary concern was thimerosal, a preservative containing ethylmercury. This has been added to vaccines since the 1930s because it allows pediatricians to pull multiple doses from a single large vial. Yet, doctors have long known that mercury is a toxin that interferes with the development of the brain. It seemed biologically plausible to me that a vaccine containing thimerosal could poison a baby's brain and trigger an autism-spectrum disorder. Finlay's behavior also affected our decision. He had symptoms of attention deficit hyperactivity disorder, which can coexist with Asperger's, and he was becoming less able to focus on the simple tasks of getting through a 3-year-old's day.

With our decision made, one question haunted us: Was it fair to vaccinate one and not the other? If not, to which child was it not fair? The one who was saddled with behavioral challenges that may or may not have been caused by vaccines, or the one who would be forever susceptible to diseases that could kill him? And what about the members of our small Vermont community? The only reason we had the luxury of this debate is because most people vaccinate, providing what Dr. Halsey calls "herd immunity" to our children. Didn't we owe our neighbors the same protection?

You can't understand the current state of the vaccine-autism controversy without first examining the history of the national immunization program. By design, vaccines cause an immune-system response, but in rare instances, the reaction is not the intended one. Most parents view these odds favorably when weighed against the protection immunizations provide. Still, throughout the 1970s and 1980s, parents successfully sued vaccine manufacturers, claiming vaccines caused a range of unexplained illnesses, such as epilepsy and mental retardation. It was against this backdrop that the government established the National Childhood Vaccine Injury Act in 1986, which spawned the National Vaccine Injury Compensation Program in 1988. Since then there have been 8,363 claims filed, with 1,004 compensated for a total of $879 million. Presently, the fund totals $2.7 billion. The drug makers were better protected from lawsuits, and the public had recourse in the event of a vaccine-related injury. Everyone felt safe and happy.

That sentiment began to shift in the late 1990s with the unexplained rise in autism-spectrum disorders. Two events put vaccines—and specifically, thimerosal—into the spotlight. First, in 1998, a now discredited British study published in the Lancet linked the MMR shot to autism in 12 children. Concurrently, the Food and Drug Administration mandated a review and risk assessment of all mercury-containing foods and drugs, and vaccine manufacturers provided detailed information about the thimerosal content in their products. In 1999, the American Academy of Pediatrics recommended that thimerosal be eliminated from all vaccines as a precautionary measure. Today, most childhood vaccines are free of thimerosal, although some still contain it.

Instead of increasing the public's confidence in the safety of vaccines and the trustworthiness of the CDC, removing thimerosal had the opposite effect. Thousands of people began to seek compensation from the vaccine fund, but because autism is not listed on the Vaccine Injury Table, their cases go to the Office of Special Masters of the U.S. Court of Federal Claims, a.k.a. the vaccine court. As of July 2008, there were 5,426 autism claims, which have been divided into three test cases based on three theories of general causation. The cases are ongoing with no deadline set for rulings.

I interviewed almost a dozen doctors and scientists—obviously educated and all sincere—and each one scoffed at the suggestion that vaccines can cause autism. It's indicative of the formidable scientific consensus that had emerged by 2004, which rejected the causal link between vaccines and autism. This includes the FDA, the CDC, the American Medical Association, the World Health Organization, and the Institute of Medicine, a nongovernmental, not-for-profit organization widely considered the highest medical authority in the country. The IOM's Immunization Safety Review, published in 2004, recommended that funding for autism research be channeled into more promising areas than exploring a link to vaccines.

"The largest and best-quality studies, conducted on hundreds of thousands of kids in America and around the world, simply don't point to a link between thimerosal and autism," says John Iskander, MD, acting director for immunization safety for the CDC. Dr. Iskander guided me to a range of recent epidemiological and clinical evidence in top-tier journals such as The New England Journal of Medicine and Pediatrics. He also pointed out that the strongest studies use the CDC's Vaccine Safety Datalink (VSD), a collaborative research project among the CDC and eight managed-care associations, which provides comprehensive medical and immunization histories for 5.5 million people a year. The VSD receives no funding from the pharmaceutical industry.

Regarding ethylmercury, the form of mercury in thimerosal, the latest evidence suggests that it is less dangerous than the methylmercury typically found in fish and in the atmosphere. However, scientists are still investigating how quickly ethylmercury is excreted from the body and if organic mercury is left behind in the brain. There is also the fact that diagnoses of autism have continued to climb even after thimerosal was withdrawn from vaccines, as shown recently in a study in the Archives of General Psychiatry.

The preponderance of scientific evidence hasn't silenced the vaccine conspiracy theorists. The most vocal of them is Mark Geier, MD, a geneticist who runs a center that treats autistic children with a combination of drugs and chelation to detoxify their brains; he is considered a quack by the mainstream medical community. Dr. Geier believes the CDC is covering up the thimerosal-vaccine link, and I'd been intrigued by his claims and research, but I found it difficult to ignore the chorus of voices suggesting his methodology was faulty. Nevertheless, I read the full 262-page transcript from the Simpsonwood meeting—the Area 51 for vaccine conspiracy theorists—which details how CDC officials, vaccine manufacturers, and experts from federal health agencies, universities, and medical academies convened in Georgia in 2000 to discuss the autism-vaccine link. It revealed the stark reality that scientists were baffled by autism, but it offered scant evidence of a thimerosal-autism link or a cover-up of Nixonian proportions.

In recent years, a more nuanced critique of vaccine safety has developed, embraced by a coalition of doctors and scientists, which questions the necessity of immunizing infants at their most vulnerable moment with multiple doses of toxic cocktails. One of its proponents is David Ayoub, MD, medical director of the Foundation for Autism Information and Research. Dr. Ayoub believes the miscellaneous components of modern vaccines—formaldehyde, borax, phenol, methanol, and polyribosylribitol, to name a few—combined with various antigens creates a medicinal stew that, once mixed with other environmental factors and genetic predispositions, can't be measured by any of our current health metrics. "We are still absolutely blowing through the federal guidelines for aluminum toxicity with some of these vaccines, specifically hepatitis B, DTaP (diphtheria, tetanus, and pertussis), Hib (Haemophilus Influenzae type b), and pneumococcal," he says.

In the past 12 months, the controversy has morphed, as two new cases linked vaccines to autism in patients with mitochondrial disorders, a rare spectrum of genetic illnesses. The five shots against nine diseases that 19-month-old Hannah Poling received in 2000 triggered neurological damage with features of the autism—spectrum disorder, concluded officials from the Department of Health and Human Services, according to leaked court documents. The government agreed to pay her family for care. "I cried every day for the first two years after Hannah was diagnosed with autism," says Hannah's mother, Terry Poling. "Here I was, a nurse, and I allowed them to give her nine vaccines at once. This has opened my eyes to things I never would have believed."

The Poling case marked the first time a government agency had drawn a line connecting vaccines and autism. The second case involves a 6-year-old girl from Colorado with a mitochondrial disorder; she became severely ill a week after receiving FluMist, an influenza vaccine. She died a few months later. Rather than bring clarity to the autism—vaccine debate, these cases added complexity. There is no effective way to screen for mitochondrial disorders in infants because this is a brand-new field of medicine, explains Bruce Cohen, a neurologist at the Cleveland Clinic and an expert in mitochondrial disorders. Dr. Cohen also says the case reports aren't enough evidence to prove that mitochondrial disorders in combination with vaccines can trigger autism. Regardless, these cases have highlighted the fact that individual metabolic, genetic, and immunological variations may make some children more susceptible to neurological complications caused by vaccines.

There is increasing evidence that the scientific consensus regarding the safety of vaccines is beginning to fray. Irva Hertz-Picciotto, PhD, is a professor of epidemiology in the department of public health sciences at the University of California at Davis Medical School; she serves on editorial boards for the American Journal of Epidemiology, Environmental Health Perspectives, and Autism Research, as well as on the scientific advisory board for the Environmental Protection Agency. Hertz-Picciotto dismisses much of the antivaccine camp's evidence as lacking scientific merit, but also says the CDC's data is weak. "The short answer: The question is not settled yet," she says. "The studies are not adequate."

It's a position echoed by Geri Dawson, PhD, chief science officer for the advocacy organization Autism Speaks and a professor in the psychiatry department at the University of North Carolina at Chapel Hill. "There are three questions parents want addressed," she says. "One: Is there a higher incidence of adverse effects associated with combined vaccines compared with individual vaccines? Two: Is there a higher incidence of adverse effects associated with giving multiple vaccines to very young children? Three: Can we better identify subgroups that are especially vulnerable to vaccine injury?"

In the absence of better data, I kept finding myself drawn to the assertions of Dr. Ayoub, that something in vaccines can harm certain babies. But is my attraction rooted in fact, or in the hard truth of my son's struggles? I recognize that the chance that vaccines are responsible for Fin's behavioral challenges is small. My objective brain knows this to be true. But my subjective brain sees how my older, vaccinated son struggles, while my younger, unvaccinated son seems to glide through life with an ease and grace his brother does not know. Not vaccinating Rye assuages some of the guilt I feel for vaccinating Fin.

I flew to Rochester, Minnesota, to visit Gregory Poland, MD, PhD, director of the Vaccine Research Group at the Mayo Clinic. I'd sought out Dr. Poland because he is one of the top vaccine researchers in the world. I also contacted various vaccine manufacturers, but none would allow me into their labs.

Dr. Poland was raised in a military family, which may be why he prefers to frame his work in the language of combat. "As I went through medical school, I knew right then and there that the warrior I was meant to be was the warrior taking on infectious diseases, to prevent them," it says in a profile of him on the Mayo Clinic's Web site. "Because I just have a really hard time with death. Unwarranted death, unexpected death."

We sit in a small conference room across the hall from a lab door affixed with an orange sticker warning of biohazards. Dr. Poland is thin to the point of skinny and is one of those balding men who have chosen to embrace hairlessness and shaved their head to a sheen. He wears a crisp blue dress shirt and a tie that features glaring red squiggles. His manner is gregarious and he explains his work with a minimum of jargon.

Currently, much of Dr. Poland's attention is focused on a nascent technology he calls "vaccinomics," which is an attempt to apply genetic mapping to immunizations and to create a new medical metric. Once perfected, vaccinomics will allow doctors to quantify an individual's probability of contracting a particular disease, as well as his or her level of reactivity to a particular vaccine and chances of an undesirable side effect. Within a decade, vaccinomics could eliminate the final, small slice of risk that exists with immunizations (for instance, approximately one in 100,000 children suffers an allergic reaction to the MMR vaccine, and one in 14,000 experiences seizures after receiving the DTaP vaccine), he says. "Basically, we'll be able to say, 'You're susceptible to this disease, so we better make sure you're well vaccinated' or 'You have a 30 percent chance of having a reaction to this vaccine, and since you are at an exceedingly low risk of this disease, let's skip it.'" Obviously, it holds promise for identifying at-risk subgroups who might be genetically predisposed to react to specific vaccines.

Dr. Poland is politely dismissive of the thimerosal issue, and less polite when discussing the antivaccine activists. "I have an obligation to do good research. Everything I print is subject to peer review." He thumps a bony finger on the table for emphasis. "Does their research meet the same level of credibility?" Ultimately, and perhaps not surprisingly, given his self-appointed warrior status, Dr. Poland sees the tussle over vaccines as a conflict of hearts and minds: "What I fear is that we don't have homogeneous mores anymore. We don't seem to have common ground. The technology is always ahead of the ethics."

It took me a while to digest what Dr. Poland was saying. At first, it seemed strange that a scientist would worry about technology outpacing ethics. But after a while, I began to realize it makes perfect sense: Dr. Poland believes in better living through science. To him, the flasks and vials and brain trust on the other side of the door with the biohazard sticker represent progress and are emblematic of the goodness in man. I'd walked through that door (the Mayo PR representative assigned to my visit declined, the biohazard sticker having done its job all too well) and watched two lab technicians administer smallpox and rubella vaccines to human cells, an early step in collecting the data necessary to advance vaccinomics.

What I witnessed seemed at once incredibly hopeful, impossibly scientific, and totally disconnected from the living, breathing, in-the-flesh versions of my young boys. It made me realize just how heavily we've come to depend on medicine we don't fully understand. On a basic level, yes, we know how vaccines work. But if there's anything my research has convinced me of, it's that we simply do not have a complete grasp on all the ramifications of all those shots--yet.

To Dr. Poland, it is essential work, but it will be important only to the extent the citizenry embraces it. And that's what he's talking about. Toward the end of our conversation, he begins to expound on biological battlefield technology (Dr. Poland also does work for the Department of Defense, and much of what he does is classified). It is interesting, but I don't see the connection. "In the United States, we have the technology to cause permanent blindness to our battlefield enemies. But we've chosen not to do it," he says. "We can put a bullet in your head, but we cannot make you blind." He shakes his head. Who wouldn't take blindness over death? And who wouldn't choose immunization over risk of disease? Who wouldn't? Me, as it turns out. But in truth, something bigger than me: my son.

In the 12 months I worked on this story, I rarely felt as if I were on solid ground. I'd gone from being convinced we'd made the right choice not to vaccinate Rye to wondering if perhaps we had been complacent after all, basing our decision on our own anecdotal evidence, to again questioning the safety of vaccines. I realized that trust is at the core of this issue. Vaccination rates are falling because people are losing their trust in the CDC. The fact is, the CDC is mandated to protect the larger public good, and perhaps the limits of our current vaccine technology means that there will be collateral damage. But, what parent of an autistic child is going to accept that cold truth?

The trust question goes both ways. "The real tension surrounds the fact that the pharmaceutical, medical, and federal communities are convinced that if the public thinks vaccines are harmful, they'll stop immunizing," says Kevin Conway, a Boston-based attorney whose firm has represented 1,200 vaccine-related cases. "They don't trust the public to make informed decisions, and at the same time, the public doesn't believe the scientific evidence that vaccines are safe for everyone."

Distrust is also festering because science can't explain why autism is rampaging through our society. "We've expanded the criteria for diagnosing autism, and so that explains some of the rise," says Ann Wagner, MD, PhD, chairwoman of the National Institutes of Health Autism Coordinating Committee. "We're also looking at a range of genetic and environmental factors, but the truth is, we just don't know."

To counter the falling rates in vaccination, and placate apprehensive parents, various doctors have developed alternative vaccine schedules, the most respected of which is by Robert W. Sears, MD, author of The Vaccine Book. Currently, 70 doctors follow the Sears Selective schedule. "Vaccines are very important, and I worry that we're going to have a bigger problem with diseases because parents are scared away from vaccinating," says Dr. Sears. "I'm not suggesting my approach should be our national policy. My schedule requires a lot more visits to the office and access to good health care. What I do want is for the CDC or the American Academy of Pediatrics to support an alternative approach so that pediatricians are more comfortable being flexible, and parents and doctors can work together as a team."

It is a welcome alternative to pediatricians who, following the CDC's guidelines to the letter, recommend vaccinating your baby before he even leaves the hospital, starting with the Hep B shot that protects against a sexually transmitted disease. Only 1 percent of mothers carry Hep B, and they can pass it on to their baby at birth. Dr. Sears questions whether it makes sense to give all babies a vaccine containing a marinade of chemicals that can cause uncomfortable side effects to protect this 1 percent.

Dr. Sears has looked closely at the CDC's vaccine schedule and has concerns that echo Dr. Ayoub's. "My biggest fear is the lack of research into the practice of giving so many vaccines at once, and at such a young age," says Dr. Sears. The Sears schedule separates shots according to chemical and heavy-metal makeup, and some vaccines are delayed until the immune and neurological systems are better able to cope with the load. I can see the appeal, but it's also worth noting that there have been no studies that compare rates of autism for children on the CDC schedule versus the Dr. Sears schedule.

Finlay is 6 now. He's learning to apply his tremendous energy in more productive ways. He loves to fish, and over the summer, we dug worms every Thursday morning, then drove to a nearby pond to cast and reel, cast and reel. Sometimes, we even caught something, but he seems to accept that fishing isn't really about the fish. His psyche is still a great, simmering thing that is apt to boil over at a moment's notice. When this happens, we read on the couch. He likes wilderness stories starring young boys who skin beaver and fashion clothes from deerskin. He still takes his bow-and-arrow making very seriously—he's crafted more than 70—and I love that about him.

We may never know with certainty why Fin is the way he is, if his path would have been easier if he hadn't received those shots, just as we'll never know what diseases he won't get because he had those vaccines. And what about Rye? Could we live to regret our decision to forgo his vaccinations? We could.

I believe I may never fully understand the implications of our vaccinating decisions. But increasingly, I recognize that this has, in a circuitous way, helped me accept my kids for exactly who they are. Fin is Fin--a spirited, sensitive, and yes, often challenging boy. I can spend my days wondering if those shots did this to him. Or I can spend my days loving him and basking in the companionship he so freely offers. Which would you choose?

Additional reporting by Ben Court and Heather Hurlock

Talk About Curing Autism (TACA) provides general information of interest to the autism community. The information comes from a variety of sources and TACA does not independently verify any of it. The views expressed herein are not necessarily TACA’s. TACA does not engage in lobbying or other political activities.

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