Showing posts with label Gerberding. Show all posts
Showing posts with label Gerberding. Show all posts

April 18, 2007

Julie Gerberding: Getting out the BIG shovel

I sit here trying to come up with a post on this that does not contain any offensive synonyms for animal leavings, but I am hard pressed to do it. When I signed onto this debate almost three years ago, we heard the same thing from the CDC yet they have done NOTHING to get us any closer to finding answers to the questions that parents have been screaming at them. It is completely absurd.

The statements Gerberding makes in this "hearing" are laughable.

CDC chief: Autism not overlooked

By JEFF NESMITH
The Atlanta Journal-Constitution
Published on: 04/18/07

Washington — Autism is an "urgent" concern of the Centers for Disease Control and Prevention, its director, Dr. Julie Gerberding, told senators Tuesday.

Although the CDC has been criticized by some autism activists and members of Congress, Gerberding said the Atlanta-based agency is best equipped to do the surveillance and research needed to understand and respond to the disorder.
THEN DO IT!!!!!!

GIVE US A VALID, REPLACEABLE, TRANSPARENT VACCINE/AUTISM STUDY!

YOU HAVE THE MONEY, YOU HAVE ALL THE DATA, DO IT!

STOP PRETENDING THAT DENMARK AND VERSTRAETEN ACTUALLY SUPPORT THE CLAIM THAT VACCINES ARE SAFE FOR OUR KIDS!

GIVE US THE AMISH STUDY THAT YOU WERE CHARGED WITH DOING IN 1982!

STUDY THE CHILDREN THAT ARE LOOSING THEIR AUTISM DIAGNOSIS AFTER DAN! TREATMENT!

DO IT ALREADY!!!!

IF YOU ARE NOT GOING TO DO IT THEN STOP TALKING ABOUT AUTISM!

AND PLEASE... PLEASE... STOP SAYING THAT YOU CARE WHAT IS GOING ON WITH OUR CHILDREN!

YOU LOOK RIDICULOUS!

"The profound lifelong impact of autism spectrum disorders, tremendous costs to the affected individuals and their families, the lack of known causes or cures and concerns about the increased rates of diagnosis all make autism spectrum disorders one of our urgent realities," she told a Senate appropriations subcommittee.

She said "CDC recognizes that parents want answers," adding, "We share their frustration at not having more answers about the causes and possible cure."
This statement is just a lie. No other way to say it. She is lying.
Sen. Tom Harkin (D-Iowa), whose Appropriations subcommittee on the departments of Labor, Education and Health and Human Services held the hearing, said that "millions of families are grappling with the profound difficulties of understanding and coping with this disease."

"We've got to do something about this," Harkin said.

Testifying with Gerberding were the director of the National Institute of Mental Health and a generally supportive group representing families and advocacy organizations.

Not represented at the hearing were autism activist groups that have accused the CDC of concealing evidence of a link between childhood vaccinations and the disorder.
I am sure that our invitation was lost in the mail. Again.
However, while the Senate committee hearing was under way, two members of the House announced that they will reintroduce legislation to end what they called "a conflict of interest whereby CDC is responsible for both vaccine promotion and vaccine safety."

Reps. Dave Weldon (R-Fla.), and Carolyn Maloney, (D-N.Y.,) said they will introduce the bill Thursday. Their bill last year that would remove the CDC's responsibility for vaccine safety did not pass.

UPDATE:

My good friend Wade responds to my post with a What What, and like me, far less civility than those who read his blog are used to.

UPDATE:
From John Gilmore of A-CHAMP:

If you were to deliberately design a plan to not find the cause of a disease, or even accurately count how many people are affected with a disorder, you couldn't have done better than the CDC management under Dr. Gerberding. She has not brought us an inch closer to finding the cause of autism or any treatments. She has destroyed confidence in the CDC and much of the federal public health apparatus.

It is time for her to go. And I think all autism organizations should give serious thought to calling for her resignation.

John Gilmore

November 30, 2006

NAA and co. Write to Barton About CAA

Update on the Combating Autism Act – November 30, 2006

The following letter has been sent to Chairman Barton in an effort to reiterate the need for the mandate of specific environmental research in the Combating Autism Act.

November 29, 2006

The Honorable Joe Barton
2109 Rayburn House Office Building
Washington, D.C. 20515-4306

Re: Combating Autism Act: New Study Supports the Need for Urgent Action.

Dear Chairman Barton,

Thank you for your ongoing efforts to complete work on the Combating Autism Act before the end of the current session. Attached please find a pre-publication release from a group at University of Texas Southwestern Medical Center that supports the urgent need for a significant increase in funding for research on the role of environmental factors (including vaccines) in causing autism spectrum disorder (ASD): “Evidence of Toxicity, Oxidative Stress, and Neuronal Insult in Autism” (Journal of Toxicology and Environmental Health, Part B, 9:985-999 (2006)).

We ask that your bill include (1) a specific authorization to NIEHS (leaving centers a matter of discretion); (2) the Autism Advisory Board (to provide a more hands-on tool for community and researcher feedback and recommendations to ensure the most useful and strategic research), and (3) a subject matter mandate that research topics specifically include vaccines, other biologics, and their preservatives. These latter two items were addressed in the Senate report and colloquy but are of such importance that they should be included in the statute itself. We also urge adoption of the floor statement submitted on behalf of the community two weeks ago, a copy of which is also attached for your convenience.

S. 843 authorized $45 million over five years for Centers of Excellence in Environmental Health and Autism. The bill was the product of months of detailed negotiations and compromises involving dozens of organizations in the ASD community, federal agencies, and a lot of hard work by Senate staff. The specific authorization reflected the need for a significant increase in funding for environmental research for two simple reasons.

First, the nation is confronting with the leading edge of a costly and debilitating ASD epidemic (1:166 affected children). As with any epidemic, while there may be underlying genetic susceptibilities, there must be an environmental cause (virus, fungus, heavy metals, pollutants, etc.). Once the cause is discovered, immediate steps can be taken to prevent new cases and abate the epidemic.

Second, as is the case with lead poisoning, many cancers, and several other chronic disorders, knowledge of the environmental cause or triggers leads directly to effective treatments. These will provide those with ASD the best possible quality of life and the ability to make the greatest possible contributions to society.

Even with the more comprehensive list of subject matter topics for research focusing on the cause, prevention, and treatment for ASD which you have included in your draft, whether the research in fact gets done depends on the money actually spent. We recognize that as an authorizing bill this is just the first step, and that the ultimate research agenda depends on appropriations and discretionary decisions. However, clear Congressional direction at the authorizing stage will give the community an important tool, and Congress a point of reference for oversight, to work with the appropriations committees and the administration to implement the needed research agenda.

The federal officials most responsible for funding research into the cause and treatment for ASD provide the best – and frankly scariest – justification for a Congressionally mandated significant increase in funding, accountability, and oversight. CDC Director Dr. Gerberding was recently quoted in a November 22 UPI story (“Autism Picture Still Incomplete”): “We just simply don’t have answers to the cause of this disorder or the disorders that fall into the autism spectrum, . . . we don’t have a complete picture of the scope of the problem.” NIMH Director Insel was quoted in the same article: “We don’t really understand that whole landscape very well, . . . There's just a whole series of questions that we need to begin to define answers to much more precisely.” “Ironically,” Insel admitted, “this is such a high priority for the National Institutes of Health -- and we have a large hospital and a huge clinic, with 18,000 people here in Bethesda -- (but) there has not been an autism program here until now. . . . As it is, autism has arrived at the stage where polio stood in the mid-1950s.” Dr. Gerberding conceded in an earlier article (“Autism Research Stance Shifting?): “"When you're dealing with a problem as complicated as this one and as important to so many children and so many families across the United States, we have a responsibility to be open to any and all hypotheses.” Exactly so, but Congress must direct, appropriate, and oversee funding to make sure that no stone is left unturned.

Solutions to the many ASD puzzles must be based upon sound science. But the urgency of the need coupled with a lackluster track record of NIH discretionary decisions underfunding needed research in the past demands more active Congressional direction and oversight. We fully support your overall NIH initiative for improved transparency and accountability, and want these principles applied against the ASD epidemic immediately.

The enclosed critical review article, from Congressman Barton’s own district – the University of Texas Southwestern Medical Center, provides an excellent roadmap and summary of recent research, much of it privately funded, on the environmental causes and the various biological dysfunctions associated with ASD. The existence of an epidemic indicates environmental causation:

The increase in public awareness and broadening of the criteria may be possible contributing factors; however, the substantial increase in the rate of autism revealed by epidemiological studies and government reports implicates the importance of external or environmental factors that may be changing (USDE, 2003; Chakrabarti and Fombonne, 2001; Palmer et al., 2006).

Several environment-based mechanisms of causation are set forth:

Many theories were postulated regarding the underlying cause of autism. For example, autism was implicated to be related to the measles, mumps, and rubella vaccine (Wakefield et al., 1998, 2000; Wakefield, 2003); mercury in vaccines (Bernard et al., 2002; McGinnis, 2001); immune system dysfunction (Cohly and Panja, 2005; Warren et al., 1990, 1992, 1995; Singh et al., 1993; Weizman et al., 1982); fungal infection (Shaw et al., 1994; Shaw, 1996), toxicity (McFadden, 1996); metabolic abnormalities (Waring and Klovrza, 2000; Waring and O’Reilly, 1990; Alberti et al., 1999); and “leaky gut syndrome”(Vantrappen and Geboes, 1993). Most recently, studies have suggested that decreased glutathione levels and increased oxidative stress may play a role in the pathology (James et al., 2004). Which of the many theories may be correct and/or how the various theories may fit together remains unclear. It is important to note that these theories are based on small studies and much more research is needed.

But this orchard of low-hanging fruit will not get picked without a clear authorization from Congress.

The review cites several studies demonstrating that children with ASD have difficulty eliminating metals including mercury from vaccines and the environment. The review cites reports from the “real world” of families coping with ASD:

The Autism Research Institute collected data from over 22,300 parents of children with autism on the behavioral effects of biomedical interventions. The survey includes a list of 45 medications, 23 non-drug supplements or biomedical treatments, and 9 special diets. The parents were asked to rate the treatment on a 6-point scale. Of these 77 choices, parents rated chelation therapy (or the removal of heavy metals) as the highest. Seventy-six% of parents said that their child “got better” on this treatment. The next most effective treatment was a gluten and casein free diet at 65% (ARI, 2006).

Yet NIH has only recently announced but not yet begun a clinical trial of chelation that has been used by the few families that can afford it for years.

The article’s conclusion offers an ominous warning:

The evidence presented in this article suggests that some of these children may be experiencing neuronal cell damage sometime after birth as result of insult. The evidence also suggests that these children may be selectively vulnerable to the impact from external or environmental factors. Some children with autism may be like the canary in the coal mine, exposing policy and/or environmental issues that need to be addressed.

We hope that Congress will be able to say that it has done everything possible to stop and treat this epidemic.

The following organizations represent a broad range of families, advocates, and researchers involved with ASD. We appreciate your efforts and look forward to working with you to pass – and implement – a law that will truly make a meaningful difference for those with ASD and their families.

Sincerely,

The Deirdre Imus Environmental Center for Pediatric Oncology
Autism One
Generation Rescue
National Autism Association
SafeMinds
Talk About Curing Autism (TACA)

November 28, 2006

Time: Troubles at the CDC

What Ails The CDC: Staff turnover, morale problems and charges of mismanagement couldn't have come at a worse time for the guardians of U.S. public health
By CHRISTINE GORMAN
Time Magazine
Sunday, Nov. 19, 2006

Julie Gerberding was still a deputy director of the Centers for Disease Control and Prevention (CDC) in 2001 when someone started mailing anthrax spores to newsrooms and politicians' offices around the country. A telegenic personality who connected easily with journalists, Gerberding quickly became the public face of the CDC--a rare cool head among a parade of increasingly confused health bureaucrats. The fumbling she witnessed behind the scenes convinced her that the CDC's troubles extended beyond the need for better communications. She made her case to Tommy Thompson, then Secretary of Health and Human Services (HHS), and within a year was appointed director of the agency--the first woman to hold that job--with a mandate to radically reshape the CDC.

Five years later, Gerberding finds herself in the public eye once again, but this time she's under attack. The massive reorganization she ordered--combined with painful budget cuts in key divisions--seems to be tearing the agency apart. Six directors of the CDC's eight primary scientific centers have left. Researchers are sniping at one another in public and on the Internet. The agency has been targeted by three different congressional probes. And a blistering report, leaked last week, by an outside consultant who studied the agency's response to Hurricane Katrina found chaos and mismanagement at the very top.

Nobody is claiming that the CDC has become another governmental basket case like FEMA--at least not yet. Indeed, the speed with which this past summer's outbreak of lethal food poisoning was traced to spinach tainted by runoff from a particular herd of cows in California is testimony to the CDC's continuing expertise. But the bad publicity comes at the worst possible time for the agency and its director. Congress is wrapping up its final budget for 2007, and the Administration is starting to draw up a preliminary budget for 2008. If lawmakers believe that Gerberding is floundering, her institution's budget will suffer.

That's the last thing the U.S. needs. As the nation's premier guardian of public health, the CDC is responsible for researching, tracking and counteracting newly emerging infectious diseases like West Nile and SARS. Doctors rely on it to develop unbiased recommendations on a wide range of medical issues from when to vaccinate children to how best to battle obesity. It also directs funds to individual state and local public agencies to shore up their own community health efforts.

Ironically, it is increased CDC funding mandated by Congress for high-profile threats like bioterrorism and flu pandemics that has drained money from areas of public health that may actually be more pressing. Among the hardest-hit programs: AIDS prevention (down 19%), tuberculosis control (down 16%) and preventive-health block grants for outbreaks of West Nile disease and other unexpected events (down 17%).

But what really troubles the most vocal critics is their sense that the CDC's devotion to pure science--a long-established mandate to follow the trail of medical evidence wherever it leads--has been sabotaged. AIDS specialists today feel that they are being constrained not to say anything positive about condoms, while others complain that more cash bonuses are being given to administrators than to researchers. "It's the policies and the direction of the institute I'm most concerned about," says Dr. Brad Woodruff, an epidemiologist in the organization's Maternal and Child Nutrition Branch. Woodruff is particularly incensed that the agency's new jet, which is supposed to be for medical emergencies, was used by HHS Secretary Mike Leavitt to make promotional appearances on behalf of President Bush's Medicare drug plan.

The centerpiece of Gerberding's reorganization was her decision to replace the agency's 11 often insular centers with four coordinating bodies that would, in theory, respond to emergencies with more agility. Closer contact between infectious-disease and environmental experts, Gerberding says, has already resulted in faster tests for detecting botulism.

But some within the agency complain that the main difference they have seen so far is that their work is more likely to be second-guessed. "Scientists feel less empowered to make decisions," says Dr. Stephen Cochi, who has worked at the CDC for 24 years, currently in the Global Immunization Division. "There's more bureaucratic filtering." Decisions that were routinely made in Atlanta, he and others say, must now be approved by higher-ups in Washington. Requests for anything but emergency travel have to be made 90 days in advance.

As in so many other internecine battles, it can be hard to tell where the whining stops and the real problems begin. The CDC was due for a major overhaul, and it's human nature--even among scientists--to resist change. What started off as hallway grumbling, however, has grown into an ugly public ruckus, thanks to an unofficial employee blog www.cdcchatter.net and a few well-directed Freedom of Information requests from the Atlanta Journal-Constitution.

Through it all, Gerberding has stood firm. "The CDC was not broken," she says. "The reason to undergo this [reorganization] is that the world was changing so dramatically." As for charges of political interference, she is unapologetic. "This is a public-health agency, and by its very nature, we're never going to satisfy every single constituency," she says candidly. "I tell [Administration officials] this is the science. This is the recommendation. What they do with it is beyond my control."

Not everybody blames Gerberding for the turmoil. "I don't think anyone denies that there's a morale problem at the CDC," says Dr. Georges Benjamin, executive director of the American Public Health Association. But he attributes much of the upheaval to government-wide belt tightening rather than to Gerberding's reorganization, noting that core programs at the CDC have been cut 4.5% in each of the past two fiscal years. He and other experts believe that the agency needs at least $15 billion a year to do all the jobs it has been assigned--nearly twice the current budget of $8.5 billion.

Perhaps the most immediate problem is the number of senior-level people who are leaving. Part of that is an unavoidable function of aging--40% of the CDC's 9,000 employees will be eligible to retire in 2008. But there's also speculation that older scientists are being pushed to leave early. Either way, "you don't replace the experts at CDC easily," says Robert Keegan, deputy director of the agency's Global Immunization Division. "Management has said they've enacted better emergency standards, but until there's an emergency, you don't know."

State and local public-health officials are keeping a close eye on all the drama. "The most difficult organization in the world to change is a successful organization [like the CDC]," says Paul Halverson of the Arkansas department of health and human services. "If you're a company that is losing money every month, then it's easy to see the need to make a change." Of course, in this case, it's not just money but lives that are at stake.
With reporting by Greg Fulton / Atlanta, Alice Park / New York

April 9, 2006

CDC is "Disapointed" with USA Today Ad

Statement
For Immediate Release
April 6, 2006 Contact:
Division of Media Relations
404-639-3286
CDC Statement regarding autism-related advertisement in USA Today

We know that autism is a heart-wrenching situation for many families and many children and it presents special challenges that we would certainly want to prevent and do anything we could to avoid. When it comes to the nation’s immunization recommendations, the CDC and Public Health Service are always guided by one overriding goal and interest—all our recommendations are designed to protect the health and well being of all children.

We are very disappointed in an advertisement that appears in today’s edition of USA Today. The advertisement completely mischaracterizes the efforts of CDC, the American Academy of Pediatrics, the Institute of Medicine, and others to protect the health and well being of the nation’s children. CDC has sponsored multiple public meetings and scientific reviews, we’ve involved numerous outside organizations and experts in our research and recommendations, and we’ve made continued investments in research designed to discover factors which may place children at risk for developing autism. Importantly, if levels of thimerosal found in vaccines, including influenza vaccines, were associated with harm, CDC, the Public Health Service, and the nation’s physicians (e.g., the American Academy of Pediatrics, the American Medical Association, and American Academy of Family Physicians) would not recommend their use.

We’ve made substantial progress in removing thimerosal from vaccines – and have done so without placing infants and children at risk for potentially serious vaccine preventable diseases. As we continue in our efforts to further reduce the use of thimerosal in vaccines, we must also ensure, particularly in the case of influenza, that our efforts do not create serious undesirable outcomes, such as vaccine shortages that would place people, including children, at risk. History has shown that disruptions in vaccine supplies can render the population more vulnerable to diseases we know we can prevent.

We don't know, unfortunately, for children with autism what caused it, nor do we have sound, scientifically valid information on effective treatments. That's a fact. We just simply don't have answers to the cause of this disorder or the disorders that fall into the autism spectrum. We don't have a complete picture of the scope of the problem. We're just learning about the subtleties that can be early signs of autism, we're learning about the importance of early detection, and we're learning about the importance of early treatment, but we have a long way to go before we really understand the scope and magnitude of this problem in our country and what the trends really mean.

As we're looking for answers related to the causes and effective treatments for autism, we have to also be careful not to base our health recommendations on unproven hypotheses or fear. We have to base our decisions on the best available science that we have in front of us, and today the best available science indicates to us that vaccines save lives, and that's a very, very important message for all of us to remember.

For more information about autism, immunizations, or thimerosal, we encourage you to visit the CDC website: www.cdc.gov

April 5, 2006

AJC: Autism Controversy Eats at Credibility of CDC

Autism controversy eats at credibility of CDC
By ALISON YOUNG
The Atlanta Journal-Constitution
Published on: 04/06/06

The Centers for Disease Control and Prevention, rarely the subject of public controversy, is facing an emerging credibility crisis on the emotional issue of whether old-style vaccines containing a mercury preservative caused autism in thousands of children.

The agency is being accused of cover-ups and scientific manipulations by a vocal group of autism advocates and is facing questions from some high-profile members of Congress.

As the debate and controversy increasingly finds its way into pediatricians' offices, average parents of healthy children are questioning whether vaccines are safe, sometimes even refusing inoculations.

The CDC and other public health officials insist such questions lack a basis in fact or science. Their greatest concern is that the broadening debate holds the potential to put a new generation of children at certain risk of deadly diseases if confidence in the safety of vaccines is lost and they don't receive recommended shots.

"I think it's huge," said Dr. Julia McMillan, a member of the American Academy of Pediatrics committee that makes vaccine recommendations. "There's no pediatrician in practice that doesn't confront this on a weekly basis: families who are questioning the need for – and in some cases refusing — vaccines for their children."

But the academy and the CDC are in agreement: They say there is no evidence to support a connection between autism and the mercury-based preservative thimerosal, which they stress is no longer used in most pediatric vaccines.

"We simply don't know what the cause of autism is," Dr. Bob Davis, the CDC's director of immunization safety, said Wednesday. Nonetheless, the CDC finds itself at the center of criticism.

A full-page ad scheduled to run in today's editions of USA Today, the nation's largest-circulation newspaper, accuses the CDC of "causing an epidemic of autism" by recommending that children receive a series of vaccines that until 2001 contained thimerosal.

The ad, placed by a group of autism advocacy groups, quotes environmental lawyer Robert F. Kennedy Jr. as saying: "It's time for the CDC to come clean with the American public."

But what stings public health advocates more is a letter sent Feb. 22 by Sen. Joseph Lieberman (D-Conn.) and seven other members of Congress. The bipartisan group asks that the CDC not take the lead on a new study examining the vaccine-autism issue.
"If the federal government is going to have a study whose results will be broadly accepted, such a study cannot be led by the CDC," the group wrote Dr. David Schwartz, new director of the National Institute of Environmental Health Sciences. The institute, a part of the National Institutes of Health, will convene a panel in May to discuss how to analyze a key CDC database to determine whether autism rates have dropped since thimerosal was removed from vaccines.

The letter was also signed by Sen. Debbie Stabenow, (D-Mich.), Rep. Dave Weldon, (R-Fla.,) Rep. Chris Smith, (R-N.J.), Rep. Carolyn Maloney, (D-N.Y.), Rep. Dan Burton, (R-Ind.), Rep. Joseph Crowley, (D-N.Y,), and Rep. Maurice Hinchey, (D-N.Y.).
Agency officials said Wednesday they are proud of the CDC's work on thimerosal safety issues and that they have looked hard to find a link as well as to find any other cause of autism.

"It was an unfortunate choice of language," Davis said of the Lieberman letter. "They and everyone else are certainly entitled to their opinion. We stand by all the research we have done."

Public health officials who work with CDC are more blunt.

"I think it's shocking," said Dr. Martin Myers, executive director of the National Network for Immunization Information and a professor of pediatrics at the University of Texas medical branch in Galveston.

"The loss of public trust in one of the most extraordinary institutions in the world. I'm not quite sure how that has occurred, but it has, and that's one of the unfortunate consequences," Myers said.

The controversy, which erupted as some autism advocates rallied on Capitol Hill today in conjunction with National Autism Month, is gaining political traction, moving well beyond an initial core of autism activists, CDC, public health and congressional officials all agree.

There are many parents of autistic children who believe, as do most pediatricians and scientists, that there is no scientific evidence that thimerosal caused autism and other neurological disorders. That issue was settled for most in a widely publicized 2004 report by an expert panel convened by the National Academy of Sciences Institute of Medicine.

But the report has been the subject of controversy and intense scrutiny since it was published.

Parents of many autistic children insist that thimerosal caused the disorder, because it appeared around the time their children received vaccinations. Their advocates also point to what they say is intriguing new research in animal models indicating that some individuals may be more sensitive to thimerosal than others. Martin Cowen, whose family lives in Jonesboro, is one such parent.
Cowen is convinced thimerosal-containing vaccines caused his son Lindsey's autism. Lindsey, who turned 8 last week, does not speak, has not been toilet trained and cannot be allowed outdoors without being restrained for fear he'll run into traffic, his father said.

Cowen is highly skeptical of the CDC, a position shared by a cohort of parents and advocates across the country.

"An enormous effort is being made to deny the connection," he said of the CDC. "What do I think their motive is? They are very interested in having the herd vaccinated... They don't think of people as people suffering individually. It's the greatest good for the greatest number."

The National Immunization Program, run by the CDC, coordinates immunization activities across the country. Increasing the rate of immunization against disease is a cornerstone of public health.

At the same time, the CDC also is charged with monitoring vaccine safety. It's an inherent conflict of interest, said Weldon, a doctor before he was elected to Congress.

"They really do have a credibility problem," said Weldon, who serves on the committee that decides the CDC's budget. "Part of the credibility problem is it's asking them to investigate a problem that they may have created."

Weldon became involved in the thimerosal issue seven years ago. "Honestly, at first I was very dubious," he said. "As I looked at it more and more, I began to feel there is some validity to this."

Weldon said the recent interest by Lieberman and others on Capitol Hill is a sign the issue is gaining political traction. Lieberman was unavailable for comment.
The controversy and public debate is likely to be further fueled by the full-page ad being paid for by a coalition of the autism activist groups led by Generation Rescue. The ad promotes a sophisticated Web site, www.PutChildren First.org, which includes links to CDC documents, e-mails and transcripts the groups say support their contention of an agency cover-up.

CDC spokesman Glen Nowak said many of the documents on the site have been in the public domain for years, and are presented out of context and in ways that may "look quite ominous" – when they're not.

"It's a very challenging issue," he said. The CDC is bracing for a spike in calls today from parents with questions and is increasing staffing at its public help line, 1-800-232-4636.

April 4, 2006

The Age of Autism: Hot potato on the Hill

The Age of Autism: Hot potato on the Hill
By DAN OLMSTED

The newly proposed legislation to study the autism rate in never-vaccinated American kids could settle the debate over vaccines and autism once and for all. Does that mean it will never happen?

This week U.S. Rep. Carolyn Maloney, D-N.Y., stepped out front on the issue. She announced at a briefing at the National Press Club that she is drafting legislation to mandate that the federal government find the answer to that question.

Notice the word "mandate" -- as in "direct," which is the language the bill uses. As in, quit making excuses and just do it.

Bureaucrats and lobbyists and "experts" sometimes forget that the power in this country resides with the people, who express their will through their elected representatives. This may sound rather grand, but the point is that legislators are not some "special interest" who must be humored while the permanent ruling class goes on its merry way.

That's why putting a bill before the Congress -- which Maloney says she will do by the end of April after getting as much public comment as possible -- could be a bigger threat than people realize.

After all, as Maloney said this week, "Maybe someone in the medical establishment will show me why this study is a bad idea, but they haven't done it yet."

Maloney, who credits this column with the idea to look at the never-vaccinated, also critiqued the studies that supposedly have ruled out any link between vaccines -- particularly the mercury-based preservative thimerosal -- and autism.

"The one major government study to date, the Institute of Medicine's 2004 review, has been met with skepticism from a lot of people," she said. "There are serious questions about the data set and methodology.

"Meanwhile, there is new biological evidence published in top journals, and from major U.S. universities, to support the mercury-autism hypothesis. Just last week we saw the study out of UC Davis, which found that thimerosal disrupts normal biological signals within cells, causes inflammation and even cell death.

"In short," the congresswoman concluded, "I believe that there are still more questions than answers. But answers are what we desperately need."

Surely everyone's in favor of answers, aren't they? Well, no, they're not. Already, doubts are being raised about whether there are enough never-vaccinated kids to do such a study (there are); whether it's worth doing (it is); and what the results would really show (well, let's find out).

In fact, if the feds hadn't been contentedly dozing for the last decade as the autism rate inexplicably soared, we'd already have our answer.

Back in 2002 a woman named Sandy Gottstein, who does not even have an affected child, came all the way from Anchorage, Alaska, to raise this issue at a congressional hearing.

"My question is, is the National Institutes of Health ever planning on doing a study using the only proper control group, that is, never-vaccinated children?" Gottstein asked.

Dr. Steve Foote of NIH responded: "I am not aware of a proposed study to use a suitably constructed group of never-vaccinated children. ... Now CDC would be more likely perhaps to be aware of such an opportunity."

Responded Dr. Melinda Wharton of the CDC: "The difficulty with doing such a study in the United States, of course, is that a very small portion of children have never received any vaccines, and these children probably differ in other ways from vaccinated children. So performing such a study would, in fact, be quite difficult."

Another futile effort is recounted in David Kirby's book, "Evidence of Harm," which recounts parents' compelling stories that their children's regressive autism was triggered by vaccine reactions.

The book -- just out in paperback and winner of this year's prize from the prestigious Investigative Reporters and Editors -- describes how in 2004 Lyn Redwood of the advocacy group SafeMinds sent a list of proposed studies to Rep. Dave Weldon, R-Fla.

Weldon, a strong advocate of banning thimerosal, sent the list on to Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention. Redwood's proposal No. 1: "An investigation into the rates of neurodevelopmental disorders including autism in vaccinated and unvaccinated populations (e.g., Amish, Christian Scientists.)"

Last year this column set out to test that theory among the Amish, in an unvaccinated subset of homeschooled kids and in a large medical practice in Chicago with thousands of never-vaccinated children. In this admittedly unscientific and anecdotal reporting, we didn't find very many kids with autism.

That's certainly not conclusive, but we did conclude there are plenty of never-vaccinated kids in this country, and not all of them are riding around in buggies and reading by candlelight. The total number of appropriate "controls" -- reasonably typical never-vaccinated kids -- is well into the tens of thousands, at least.

Nor is the issue pro-vaccines vs. no vaccines, as some who oppose such a study are subtly suggesting. It's safety vs. complacency.

After all, the CDC switched to an inactivated polio vaccine in 2000 when it became clear that the live polio virus was causing a handful of polio cases each year. And kids today are still protected from polio -- only now with zero chance of actually contracting it from the vaccine.

Switching to a safer vaccine did not cause a collapse in public confidence in childhood immunizations -- probably quite the contrary.

Expect to hear all kinds of excuses, including that one, from the powers that be as to why such a conclusive study couldn't, shouldn't and really mustn't be done. Then ask yourself, Why?

E-mail: dolmsted@upi.com

February 11, 2006

The Age of Autism: Doctors for mercury

The Age of Autism: Doctors for mercury
By DAN OLMSTED
UPI Senior Editor

WASHINGTON, Feb. 9 (UPI) -- As doctors and health authorities fight state bans on mercury in vaccines and keep giving it to kids and pregnant women, one fact stands out: their certainty.

The image of pediatricians and public officials as valiant defenders of mercury takes a bit of getting used to, given their longstanding efforts to keep the toxic element out of our food, our bodies and the environment.

No reasonable person -- let alone health professional -- would advocate keeping mercury in childhood vaccines unless they were absolutely certain it was an exception to this lethal legacy.

That's especially so because vaccines can be made without the mercury preservative, called thimerosal. You can take it out and still protect the health of American children through vaccination, and if you had a shred of doubt about its safety, surely you would.

If you keep it in, you had better be right.

But what is the real degree of certainty that thimerosal is safe? Is it absolute? Beyond a reasonable doubt? A preponderance of the evidence -- the lesser standard that applies in civil cases but not when someone's freedom (or life) is at stake?

Here's the kind of thing that makes doctors -- most of whom have no more ability than you or I to investigate the safety of vaccines for themselves -- feel so certain. It's a paper titled "Vaccine Safety Controversies and the Future of Vaccination Programs," and it appears in the November 2005 issue of The Pediatric Infectious Disease Journal.

The authors are from the U.S. Centers for Disease Control and Prevention, which recommends the childhood immunization schedule; the United Nations World Health Organization, which oversees the vaccination of tens of millions of people worldwide every year, and several big universities. The report was supported by "unrestricted grants from GlaxoSmithKline Biologicals, Sanofi Pasteur MSD, several universities and other institutions."

"Thimerosal has been used for (more than) 60 years in infant vaccines and in other applications and has not been associated with adverse health effects in the general population, except when persons have been exposed to amounts many orders of magnitude greater than found in vaccines or pharmaceuticals," the authors write.

That's a ringing endorsement of safety (whether it's supported by the data is an issue I'll address in upcoming columns). But keep reading: "It should also be borne in mind that the risks of thimerosal-containing vaccines to the fetus, premature infant and low-weight infant have insufficiently been studied."

Whoa. "Insufficiently studied" -- after more than 60 years of giving thimerosal to pregnant women and babies of every size and shape? Nonetheless, the CDC recommends flu shots for pregnant women and 6-to-23-months-olds and won't recommend thimerosal-free versions. As a result, most flu shots still contain mercury.

Another new study is condescendingly titled, "When science is not enough -- a risk/benefit profile of thimerosal-containing vaccines," by Australians C. John Clements and Peter B. McIntyre in the journal Expert Opinion on Drug Safety:

"Thimerosal is safe as a vaccine preservative, and should continue to be used in settings where accessibility and cost require that multi-dose vials of vaccine are available."

Clements advises the WHO on vaccine policy; McIntyre is director of Australia's National Center for Immunization Research and Surveillance of Vaccine-Preventable Diseases.

"The overwhelming weight of scientific opinion rejects the hypothesis that neurodevelopmental abnormalities are causally related to the use of thimerosal in vaccines," they point out.

This is the kind of ammunition public health officials and the American Academy of Pediatrics are firing back at proponents of mercury bans --"overwhelming" evidence that thimerosal is safe. In Illinois, the state AAP vigorously opposed the ban.

"Though well intended, these bills do not advance public health and could inadvertently diminish our state's efforts at fighting influenza," the AAP said. "Though it is a mercury-containing compound, thimerosal does not pass from the bloodstream into the brain to any significant degree."

The state legislators listened politely to that dubious assertion -- and voted to limit thimerosal in childhood vaccines anyway. But that was not the last word.

As reported by R. L. Nave in the Illinois Times last month: "Citing cost concerns and a potential shortfall for the upcoming flu season, the Illinois Department of Public Health filed for a 12-month exemption to the Mercury-Free Vaccine Act, passed last summer to limit the use of vaccines containing mercury. However, child-health-care advocates who lobbied for the bill's passage are upset by what they believe was a premeditated attempt by IDPH to circumvent state law."

This is what you call chutzpah -- public health authorities thwarting the express will of the people, certain that flu shots will save humanity and mercury never hurt anybody. Does the governor never fire anyone?

Almost lost in this crossfire is the simple fact that in 1999, these selfsame health authorities -- the CDC, the Public Health Service, the pediatricians, the family physicians -- urged drug companies to remove thimerosal from childhood immunizations in the United States as soon as possible.

Most childhood vaccines -- in the United States, not overseas -- are now thimerosal-free. But that's hardly a blanket reassurance, because most flu shots do contain thimerosal.

Yet the CDC is still studying whether thimerosal causes autism.

"We do agree the preponderance of evidence to date suggests there is no association between thimerosal and autism," CDC spokesman Glen Nowak told us last month. But he said CDC Director Dr. Julie Gerberding is committed to exploring all possibilities until the cause or causes of the disorder are identified.

"Dr. Gerberding has made it clear the CDC has not ruled out anything as possible causes of autism, including thimerosal," Nowak said. "Science is a dynamic process. We have continued to fund studies to look at the role, if any, of thimerosal."

Given these caveats, what would you do? Well, there are two maxims of medicine that might apply. "First, do no harm," is the obvious one.

The second, related concept is the precautionary principle which, according to wikipedia.org, "is the idea that if the consequences of an action are unknown, but are judged to have some potential for major or irreversible negative consequences, then it is better to avoid that action."

So: Vaccines don't need mercury. Even government experts acknowledge some possible risks -- to the fetus, for example -- are insufficiently studied 60 years on. A link to autism has not been ruled out. They're continuing to investigate, as they should.

But the doctors and their public and private allies are battling state by state to stop mercury bans, and the CDC won't recommend a thimerosal-free flu shot for kids and pregnant woman. There's a phrase for this approach:

Bombs away.

January 6, 2006

The Age of Autism: CDC Probes Vaccines

The Age of Autism: CDC probes vaccines
By DAN OLMSTED
UPI Senior Editor

The CDC is continuing to investigate whether a mercury preservative in childhood immunizations has caused cases of autism -- despite the fact a report it paid for said such research should end.

The agency wants to determine whether exposure to the vaccine preservative, called thimerosal, can be linked to autism spectrum disorders, Glen Nowak, director of media relations at the Centers for Disease Control and Prevention, told Age of Autism on Friday.

The study includes 300 children with ASDs, 200 of whom have full-syndrome autism, as well as a comparison group of children who do not have the disorders.

In 2004 a CDC-funded report by the independent Institute of Medicine concluded there was no evidence of a vaccine-autism link and efforts should go instead to "promising" autism research.

"Further research to find the cause of autism should be directed toward other lines of inquiry," the immunization review panel said. "It's really terrifying, the scientific illiteracy that supports these suspicions," said Dr. Marie McCormick, chairwoman of the IOM panel, in a New York Times article in June.

And the head of the CDC's immunization program said the same year that only "junk scientists and charlatans" take such a link seriously.

Nevertheless, spokesman Nowak said the CDC -- which sets the childhood immunization schedule that states adopt -- has not eliminated thimerosal as a suspect.

"We do agree the preponderance of evidence to date suggests there is no association between thimerosal and autism," said Nowak when asked why the CDC was continuing to pursue the issue. But he said CDC Director Dr. Julie Gerberding is committed to exploring all possibilities until the cause or causes of the disorder are identified.

"Dr. Gerberding has made it clear the CDC has not ruled out anything as possible causes of autism, including thimerosal," Nowak said. "Science is a dynamic process. We have continued to fund studies to look at the role, if any, of thimerosal."

The study was designed in 2003 and data collection -- which includes evaluation of each child and their immunization history -- began last year, Nowak said. A letter dated Nov. 8 and an accompanying brochure were provided by a parent who received them.

"In this study, the CDC wants to find out if children who received vaccines and medicines with Thimerosal as infants are more likely to later have developmental problems such as Asperger's Syndrome or autism," says the letter, sent on behalf of the CDC by a research firm and Kaiser Permanente, one of three HMOs involved.

"Your participation in this study may help doctors learn about the possible risks of vaccines and medicines that contained thimerosal."

The mother who received the letter expressed dismay because most medical experts and federal health authorities have reassured parents thimerosal does not cause autism and is not responsible for the large increase in diagnoses beginning in the 1990s.

In 1999 the CDC and the American Academy of Pediatrics urged manufacturers to phase out thimerosal from childhood immunizations as soon as possible, based on the concern that the total amount of mercury received by a child could exceed some government guidelines.

But, citing five subsequent epidemiological studies, the CDC and other health authorities now say there is no evidence of an association.

The CDC continues to recommend flu shots -- most of which contain thimerosal -- for pregnant women and for children 6 to 23 months of age. The agency has declined to express a preference for the thimerosal-free version, citing concern that it might cause some parents to forego immunizing their children against flu if they cannot obtain it.

In addition, tens of millions of children around the world are being injected with thimerosal-containing vaccines, based heavily on the assurances of U.S. health authorities that it is safe and does not cause autism.

Results of the study should be available in September 2007, Nowak said.

December 22, 2005

Dan Olmsted - Autism's Dick Tracy

Dan Olmsted - Autism's Dick Tracy
by Evelyn Pringle

According to officials in the nation's regulatory agencies, the main obstacle to proving or disproving a link between the autism epidemic and the mercury-based preservative, thimerosal, that was contained in childhood vaccines until a few years ago, and is still in flu vaccines, has been the inability to find a large enough group of people who have never been vaccinated to compare with people who have.

In fact, a few months ago, CDC officials claimed that such a study would be nearly impossible. On July 19, 2005, the CDC held a Media Briefing on the topic of vaccines and child health. On the issue of government research on autism, a reporter asked CDC Director, Dr Julie Gerberding: "are you putting any money into clinical studies rather than epidemiological studies, to verify or disprove the parents' claim about a particular channel, a particular mechanism by which a minority of genetically suspectable kids are supposed damaged?"

Gerberding replied: To do the study that you're suggesting, looking for an association between thimerosal and autism in a prospective sense is just about impossible to do right now because we don't have those vaccines in use in this country so we're not in a position where we can compare the children who have received them directly to the children who don't.

Dr Duane Alexander, of the National Institute of Health, agreed and said: It's really not possible ... in this country to do a prospective study now of thimerosal and vaccines in relationship to autism. Only a retrospective study which would be very difficult to do under the circumstances could be mounted with regard to the thimerosal question.

However, Dan Olmsted, investigative reporter for United Press International, and author of the Age of Autism series of reports, appears to have solved this problem when he came up with the idea of checking out the nation's Amish population where parents do not ordinarily vaccinate children.

First he looked to the Amish community in Pennsylvania and found a family doctor in Lancaster who had treated thousands of Amish patients over a quarter-century who said he has never seen an Amish person with autism, according to Age of Autism: A glimpse of the Amish on June 2, 2005.

Olmsted also interviewed Dick Warner, who has a water purification and natural health business and has been in Amish households all over the country. "I've been working with Amish people since 1980," Warner said.

"I have never seen an autistic Amish child -- not one," he told Olmsted. "I would know it. I have a strong medical background. I know what autistic people are like. I have friends who have autistic children," he added.

Olmsted did find one Amish woman in Lancaster County with an autistic child but as it turns out, the child was adopted from China and had been vaccinated. The woman knew of two other autistic children but here again, one of those had been vaccinated.

Next Olmsted visited a medical practice in Middleburg, Indiana, the heart of the Amish community, and asked whether the clinic treated Amish people with autism.

A staff member told Olmsted that she had never thought about it before, but in the five years that she had worked at the clinic she had never seen one autistic Amish.

On June 8, 2005, Olmsted reported on the autism rate in the Amish community around Middlefield, Ohio, which was 1 in 15,000, according to Dr Heng Wang, the medical director, at the DDC Clinic for Special Needs Children.

"So far," according to Age of Autism, "there is evidence of fewer than 10 Amish with autism; there should be several hundred if the disorder occurs among them at the same 166-1 prevalence as children born in the rest of the population."

In addition to the Amish, Olmsted recently discovered another large unvaccinated group. On December 7, 2005, Age of Autism reported that thousands of children cared for by Homefirst Health Services in metropolitan Chicago have at least two things in common with Amish children, they have never been vaccinated and they don't have autism.

Homefirst has five offices in the Chicago area and a total of six doctors. "We have about 30,000 or 35,000 children that we've taken care of over the years, and I don't think we have a single case of autism in children delivered by us who never received vaccines," said Dr Mayer Eisenstein, Homefirst's medical director who founded the practice in 1973.

Olmsted reports that the autism rate in Illinois public schools is 38 per 10,000, according to state Education Department data. In treating a population of 30,000 to 35,000 children, this would logically mean that Homefirst should have seen at least 120 autistic children over the years but the clinic has seen none.

It looks like the problem is finally solved. Thanks to autism's Dick Tracy, the government now has thousands of unvaccinated people to compare to people who were vaccinated.

evelyn.pringle@sbcglobal.net

December 7, 2005

The Age of Autism: 'A pretty big secret'

The Age of Autism: 'A pretty big secret'
By Dan Olmsted
UPI Senior Editor

It's a far piece from the horse-and-buggies of Lancaster County, Pa., to the cars and freeways of Cook County, Ill.

But thousands of children cared for by Homefirst Health Services in metropolitan Chicago have at least two things in common with thousands of Amish children in rural Lancaster: They have never been vaccinated. And they don't have autism.

"We have a fairly large practice. We have about 30,000 or 35,000 children that we've taken care of over the years, and I don't think we have a single case of autism in children delivered by us who never received vaccines," said Dr. Mayer Eisenstein, Homefirst's medical director who founded the practice in 1973. Homefirst doctors have delivered more than 15,000 babies at home, and thousands of them have never been vaccinated.

The few autistic children Homefirst sees were vaccinated before their families became patients, Eisenstein said. "I can think of two or three autistic children who we've delivered their mother's next baby, and we aren't really totally taking care of that child -- they have special care needs. But they bring the younger children to us. I don't have a single case that I can think of that wasn't vaccinated."

The autism rate in Illinois public schools is 38 per 10,000, according to state Education Department data; the Centers for Disease Control and Prevention puts the national rate of autism spectrum disorders at 1 in 166 -- 60 per 10,000.

"We do have enough of a sample," Eisenstein said. "The numbers are too large to not see it. We would absolutely know. We're all family doctors. If I have a child with autism come in, there's no communication. It's frightening. You can't touch them. It's not something that anyone would miss."

No one knows what causes autism, but federal health authorities say it isn't childhood immunizations. Some parents and a small minority of doctors and scientists, however, assert vaccines are responsible.

This column has been looking for autism in never-vaccinated U.S. children in an effort to shed light on the issue. We went to Chicago to meet with Eisenstein at the suggestion of a reader, and we also visited Homefirst's office in northwest suburban Rolling Meadows. Homefirst has four other offices in the Chicago area and a total of six doctors.

Eisenstein stresses his observations are not scientific. "The trouble is this is just anecdotal in a sense, because what if every autistic child goes somewhere else and (their family) never calls us or they moved out of state?"

In practice, that's unlikely to account for the pronounced absence of autism, says Eisenstein, who also has a bachelor's degree in statistics, a master's degree in public health and a law degree.

Homefirst follows state immunization mandates, but Illinois allows religious exemptions if parents object based either on tenets of their faith or specific personal religious views. Homefirst does not exclude or discourage such families. Eisenstein, in fact, is author of the book "Don't Vaccinate Before You Educate!" and is critical of the CDC's vaccination policy in the 1990s, when several new immunizations were added to the schedule, including Hepatitis B as early as the day of birth. Several of the vaccines -- HepB included -- contained a mercury-based preservative that has since been phased out of most childhood vaccines in the United States.

Medical practices with Homefirst's approach to immunizations are rare. "Because of that, we tend to attract families that have questions about that issue," said Dr. Paul Schattauer, who has been with Homefirst for 20 years and treats "at least" 100 children a week.

Schattauer seconded Eisenstein's observations. "All I know is in my practice I don't see autism. There is no striking 1-in-166," he said.

Earlier this year we reported the same phenomenon in the mostly unvaccinated Amish. CDC Director Dr. Julie Gerberding told us the Amish "have genetic connectivity that would make them different from populations that are in other sectors of the United States." Gerberding said, however, studies "could and should be done" in more representative unvaccinated groups -- if they could be found and their autism rate documented.

Chicago is America's prototypical "City of Big Shoulders," to quote Carl Sandburg, and Homefirst's mostly middle-class families seem fairly representative. A substantial number are conservative Christians who home-school their children. They are mostly white, but the Homefirst practice also includes black and Hispanic families and non-home-schooling Jews, Catholics and Muslims.

They tend to be better educated, follow healthier diets and breast-feed their children much longer than the norm -- half of Homefirst's mothers are still breast-feeding at two years. Also, because Homefirst relies less on prescription drugs including antibiotics as a first line of treatment, these children have less exposure to other medicines, not just vaccines.

Schattauer, interviewed at the Rolling Meadows office, said his caseload is too limited to draw conclusions about a possible link between vaccines and autism. "With these numbers you'd have a hard time proving or disproving anything," he said. "You can only get a feeling about it.

"In no way would I be an advocate to stand up and say we need to look at vaccines, because I don't have the science to say that," Schattauer said. "But I don't think the science is there to say that it's not."

Schattauer said Homefirst's patients also have significantly less childhood asthma and juvenile diabetes compared to national rates. An office manager who has been with Homefirst for 17 years said she is aware of only one case of severe asthma in an unvaccinated child.

"Sometimes you feel frustrated because you feel like you've got a pretty big secret," Schattauer said. He argues for more research on all those disorders, independent of political or business pressures.

The asthma rate among Homefirst patients is so low it was noticed by the Blue Cross group with which Homefirst is affiliated, according to Eisenstein.

"In the alternative-medicine network which Homefirst is part of, there are virtually no cases of childhood asthma, in contrast to the overall Blue Cross rate of childhood asthma which is approximately 10 percent," he said. "At first I thought it was because they (Homefirst's children) were breast-fed, but even among the breast-fed we've had asthma. We have virtually no asthma if you're breast-fed and not vaccinated."
Because the diagnosis of asthma is based on emergency-room visits and hospital admissions, Eisenstein said, Homefirst's low rate is hard to dispute. "It's quantifiable -- the definition is not reliant on the doctor's perception of asthma."
Several studies have found a risk of asthma from vaccination; others have not. Studies that include never-vaccinated children generally find little or no asthma in that group.

Earlier this year Florida pediatrician Dr. Jeff Bradstreet said there is virtually no autism in home-schooling families who decline to vaccinate for religious reasons -- lending credence to Eisenstein's observations.

"It's largely non-existent," said Bradstreet, who treats children with autism from around the country. "It's an extremely rare event."

Bradstreet has a son whose autism he attributes to a vaccine reaction at 15 months. His daughter has been home-schooled, he describes himself as a "Christian family physician," and he knows many of the leaders in the home-school movement.

"There was this whole subculture of folks who went into home-schooling so they would never have to vaccinate their kids," he said. "There's this whole cadre who were never vaccinated for religious reasons."

In that subset, he said, "unless they were massively exposed to mercury through lots of amalgams (mercury dental fillings in the mother) and/or big-time fish eating, I've not had a single case."

Federal health authorities and mainstream medical groups emphatically dismiss any link between autism and vaccines, including the mercury-based preservative thimerosal. Last year a panel of the Institute of Medicine, part of the National Academies, said there is no evidence of such a link, and funding should henceforth go to "promising" research.

Thimerosal, which is 49.6 percent ethyl mercury by weight, was phased out of most U.S. childhood immunizations beginning in 1999, but the CDC recommends flu shots for pregnant women and last year began recommending them for children 6 to 23 months old. Most of those shots contain thimerosal.

Thimerosal-preserved vaccines are currently being injected into millions of children in developing countries around the world. "My mandate ... is to make sure at the end of the day that 100,000,000 are immunized ... this year, next year and for many years to come ... and that will have to be with thimerosal-containing vaccines," said John Clements of the World Health Organization at a June 2000 meeting called by the CDC.

That meeting was held to review data that thimerosal might be linked with autism and other neurological problems. But in 2004 the Institute of Medicine panel said evidence against a link is so strong that health authorities, "whether in the United States or other countries, should not include autism as a potential risk" when formulating immunization policies.

But where is the simple, straightforward study of autism in never-vaccinated U.S. children? Based on our admittedly anecdotal and limited reporting among the Amish, the home-schooled and now Chicago's Homefirst, that may prove to be a significant omission.
--
This ongoing series on the roots and rise of autism welcomes comment. E-mail: dolmsted@upi.com

December 1, 2005

Out of the Abundance of the Heart, the Mouth Speaks

From John Gilmore of A-CHAMP:

Check out the CDC's official annual report:

The State of the CDC, Fiscal Year 2004, CDC Protecting Health for Life

http://www.cdc.gov/cdc.pdf

Do a search for "Autism".

What do you find?

Nothing.

Are we surprised?

Perhaps you might want to ask CDC Director Dr. Julie Gerberding, MD, MPH, what this says about CDC priorities.

Call her at 404-639-7000.

November 1, 2005

The Age of Autism: The Amish Elephant

The Age of Autism: The Amish Elephant

By Dan Olmsted
UPI Senior Editor
Oct. 29, 2005 at 2:34PM

A specter is haunting the medical and journalism establishments of the United States: Where are the unvaccinated people with autism?

That is just about the only way to explain what now appears to be a collective resistance to considering that question. And like all unanswered questions, this raises another one: Why?

What is the problem with quickly and firmly establishing that the autism rate is about the same everywhere and for everybody in the United States, vaccinated or unvaccinated? Wouldn't that stop all the scientifically illiterate chatter by parents who believe vaccinations made their children autistic? Wouldn't it put to rest concerns that -- despite the removal of a mercury-containing preservative in most U.S. vaccines -- hundreds of millions of children in the developing world are possibly at risk if that preservative is in fact linked to autism?

Calling this issue The Amish Elephant reflects reporting earlier this year in Age of Autism that the largely unvaccinated Amish may have a relatively low rate of autism. That apparent dissimilarity is, in effect, a proverbial elephant in the living room -- studiously ignored by people who don't want to deal with it and don't believe they will have to.

Here are a few cases in point.

Earlier this month the National Consumers League conference in Washington held a session on communicating issues around vaccine safety. I was on the panel and talked about the Amish and autism. In the Q&A session that followed, the first question was for me.

"Is this a proper role for a journalist, or is this just a straw dog set up there with a preliminary answer? It not only showed up where you wrote it. It was all over the place. You did very, very well for UPI (at which point I said, 'Thank you -- please tell my bosses that!') but the question is, did you do very, very well for America?

"Is it appropriate for a journalist -- you weren't reporting, you were investigating. And I just wonder if you think it's an appropriate role for you to play."

My answer: "There's different roles for the press. That's certainly a reasonable question. That is investigative reporting. This idea is something that's already been discarded -- that there's any reason why you would want to look in an unvaccinated population.

"One of my favorite comments about journalism is that it's the wild card of American democracy. The First Amendment says we can do (in the sense of reporting about) whatever we want. So one of our privileges is to get an idea in our head and go look at it."

My questioner was not finished. "I wasn't questioning whether you have a First Amendment right to do it. I think this is more of a question of the ethics, of what value we are bringing to the debate."

My response: "That's probably not a good one for me to answer. Obviously I thought it was ethical."

At that point a fellow panelist, Dr. Louis Cooper, former president of the American Academy of Pediatrics and a staunch vaccine defender, spoke up. "I would jump in and say I thought it was ethical and I think it was useful," said Cooper, a courtly and unfailingly courteous Manhattan pediatrician.

"As you've learned, it was annoying to many people. I wasn't annoyed by it because I thought you kept the process and the debate and the discussion going forward. And we have to do that for one another."

That did not end the discussion. A few minutes later a public-health professor from -- where else? Harvard -- did her own version of Jeopardy!, offering the correct "answer" in the form of a question.

"This question is for Dan. Did you mention the outbreak of polio that happened in the Amish community in the Netherlands that caused widespread problems there, and also the fact that there'd been some context with respect to history in our country in trying to reach out to the Amish to actually encourage them to try to benefit from some of the vaccine technology to the extent that we could?

"So there's been a long history in this country of the CDC trying to reach out to them to the extent that they could. Also with respect to polio, I think what's really amazing is it's such a great story, this is such an exciting time, in the sense that we are very close to global eradication. What that means is we've gone from 1988 when we had 350,000 estimated paralytic polio cases in the world every year to roughly a thousand. It's very exciting that in fact we don't have the terror or the hysteria and all of the fear that surrounded disease.

"I just want to remind everyone that one thing that's very important in the context of reporting these stories is making sure that people do remember and also realize with infectious disease is these things can come back, and until they are eradicated they can come back and devastate us just as much as they did before, except now there are a lot more people.

"There's some related news that people might find interesting. A headline in the Washington Post today, 'Polio outbreak occurs among Amish families.' So I thought people might be interested in that."

At that point the moderator, Dr. Roger Bernier of the Centers for Disease Control, said time was getting short -- why was I not surprised? -- and asked for the next "question."

One thing I've noticed is the more that people want to lecture instead of learn, the more they speak in breathless run-on sentences that are hard to stop, slow down or even diagram. They leave one with the unspoken idea that dialogue -- opening the door to new information -- is somehow dangerous.

These exchanges reminded me of the response I got from Dr. Julie Gerberding, the CDC director, when I asked her this summer, verbatim: "Has the government ever looked at the autism rate in an unvaccinated U.S. population, and if not, why not?"

Her answer, verbatim:
--

In this country, we have very high levels of vaccination as you probably know, and I think this year we have record immunization levels among all of our children, so to (select an unvaccinated group) that on a population basis would be representative to look at incidence in that population compared to the other population would be something that could be done.

But as we're learning, just trying to look at autism in a community the size of Atlanta, it's very, very difficult to get an effective numerator and denominator to get a reliable diagnosis.

I think those kind of studies could be done and should be done. You'd have to adjust for the strong genetic component that also distinguishes, for example, people in Amish communities who may elect not to be immunized (and) also have genetic connectivity that would make them different from populations that are in other sectors of the United States. So drawing some conclusions from them would be very difficult.

I think with reference to the timing of all of this, good science does take time, and it's part of one of the messages I feel like I've learned from the feedback that we've gotten from parents groups this summer (in) struggling with developing a more robust and a faster research agenda, is let's speed this up. Let's look for the early studies that could give us at least some hypotheses to test and evaluate and get information flowing through the research pipeline as quickly as we can.

So we are committed to doing that, and as I mentioned, in terms of just measuring the frequency of autism in the population some pretty big steps have been taken. We're careful not to jump ahead of our data, but we think we will be able to provide more accurate information in the next year or so than we've been able to do up to this point. And I know that is our responsibility.

We've also benefited from some increased investments in these areas that have allowed us to do this, and so we thank Congress and we thank the administration for supporting those investments, not just at CDC but also at NIH and FDA.

--

The latest response to my pesky persistence comes not from academia or government but from my own profession. Last week the prestigious Columbia Journalism Review published an article whose main thrust -- with which I concur -- was that a vigorous debate over a possible link between vaccines and autism was being thwarted by the self-induced timidity of the press.

Some reporters told the author, Daniel Schulman, that they have basically given up on the story because the criticism -- some of it from their own editors -- was so fierce, and the story was so complicated.

Schulman described Age of Autism's efforts to come at the issue "sideways," looking for possible clues to the cause of the disorder in the natural history of autism. And he mentioned our reporting on the Amish:

"Privately, two reporters told me that, while intriguing, Olmsted's reporting on the Amish is misguided, since it may simply reflect genetic differences among an isolated gene pool. ... Both reporters believed that Olmsted has made up his mind on the question and is reporting the facts that support his conclusions."

Ouch. Being slammed by one's peers is never enjoyable, although reporters need to have thick skins and realize they dish this kind of thing out every day. (And those anonymous sources really are annoying, especially when I am happy to be quoted by name about everything.)

What's interesting about the reporters' "private" remarks is the degree of presumed expertise they suggest -- that looking at the Amish is misguided "since it may simply reflect genetic differences among an isolated gene pool." Really? Where did these guys get their doctorate in genetics, Harvard?

This assertion -- that the Amish gene pool could explain everything, based on no data that I'm aware of -- is the kind of self-interested speculation masquerading as expertise that has beset the autism-vaccines discussion for far too long. The term I learned for it long ago is "convenient reasoning," and it does not always have to be conscious.

The Amish have all kinds of standard genetic mental and developmental disorders -- from bipolar to retardation -- and a lot more genetic issues to boot from this supposedly protective "isolated gene pool." The doctors who actually know something about the Amish have never suggested to me that genes have anything to do with a low rate of autism. They seem perplexed.

In upcoming columns, we'll put that question to the right people -- geneticists -- and tell you what we find. It's called reporting.

October 25, 2005

WaPo: Flu Death Risk Often Exaggerated; So Is Benefit of Vaccine

A Shot of Fear
Flu Death Risk Often Exaggerated; So Is Benefit of Vaccine

By Steven Woloshin, Lisa M. Schwartz and H. Gilbert Welch
Special to The Washington Post
Tuesday, October 25, 2005; Page HE01

Medical research often becomes news. But sometimes the news is made to appear more definitive and dramatic than the research warrants. This series dissects health news to highlight some common study interpretation problems we see as physician-researchers and show how the research community, medical journals and the media can do better.

For years, the public health community has used fear as one strategy to promote the flu vaccine. A vaccination poster distributed by the U.S. Centers for Disease Control and Prevention (CDC), for example, emphasizes that "36,000 Americans die of flu-related illnesses each year," implying that the vaccine could prevent many of these deaths.

What was an elderly person's chance of having a flu-like illness in a flu season?
Placebo group Vaccine group
Nursing Home
Study 1 (Russia) 13% 5%
Study 2 (U.S.) 15% 6%
Community
Study 3 (Netherlands) 4% 2%
Study 4 (Britain) 9% 5%
Study 5 (U.S.) 4% 2%
SOURCES: Lancet Online Cochrane Review 2005 and original journal articles

When it became aware of the vaccine shortage last October, the federal government changed course and tried to reassure Americans that going without a shot was no big deal. "We all need to take a deep breath. This is not an emergency," CDC director Julie Gerberding advised the public.

Instead of urging vaccination for everyone age 50 and older, as they had been doing, government officials recommended shots only for people 65 and older, and those in selected high risk groups. The public's response was predictable: People were upset and confused. Our local television news played a story in which a pharmacist was called "a murderer" when his vaccine supply ran out. Ironically, the crisis mentality led some to engage in behaviors that probably increased their risk. Frail elderly people, some with oxygen tanks, stood in long lines in the cold, waiting for the vaccine. Others crowded clinics and doctors' offices, increasing their chance of exposure to flu and other infectious agents.

With uncertainties about this year's vaccine supply, the CDC again recommended that highest-risk people get priority for flu shots, at least until late October. But last year's flu season may have left people confused about essential points: Just how risky is the flu? And just how effective is the vaccine? The answers to these questions may surprise readers.

How Risky Is the Flu?

First, a caveat: The risk calculations we analyze here describe typical flu seasons only. We don't consider here what the picture would be in the event of a deadly flu pandemic -- a worldwide outbreak of a new, highly virulent flu strain, the potential for which has recently drawn considerable media attention. No one really knows how likely such an outbreak is, but the risk profile would certainly change. A pandemic is a fundamentally different situation: The risk of death would be substantially higher, and untested strategies (including new treatments, quarantine and a new vaccine) would need to be implemented rapidly.

We deal here with what is known about typical flu seasons, based on data that form the basis for the federal government's flu-risk figures.

By choosing to highlight the annual number of flu deaths, the CDC employed an attention-grabbing tactic often used by public health and disease advocacy groups. It's a tactic readers should be inoculated against if they want a clear picture of the risks they face. (See "Research Basics: Understanding How Big a Risk Is," right.)

In fact, it is very difficult to know how many people die from any given disease because there is often much uncertainty in determining the cause of death. This is particularly true for the flu. That's because it shares symptoms with so many other diseases, and because people most likely to die a flu-related death are also at high risk for many other causes of death.

Flu deaths are probably undercounted because doctors do not routinely test for the flu, and because some deaths that should be attributed to the flu are given other diagnoses. For example, someone who dies from a heart attack because they are debilitated by the flu might not get counted as a flu death. Some overcounting of flu deaths also occurs: Clearly not all winter pneumonia deaths are caused by the flu.

According to the CDC, 90 percent of flu-related deaths occur among people age 65 years and older. Based on this information and the age distribution of the population, the chance of a flu-related death for people in that age group is about one in 1,000. Another way of saying this is that the chance of not dying from flu for those 65 and older is about 999 out of 1,000. (For context, the chance of a flu-related death is slightly lower than the chance of dying from a fall or other accident.)

For people younger than 65 (including children), the chance of a flu-related death is much smaller -- about one in 100,000. Of course, adults and children might be concerned about flu-related problems besides death, such as being hospitalized or just suffering with unpleasant symptoms (typically three to seven days of fever, muscle aches, headache, weakness, dry cough and runny nose). As you might guess, counting the number of flu-related hospitalizations or the number of people experiencing symptoms from the flu is even more difficult than counting flu deaths.

How Good Is the Vaccine?

Getting a shot does not guarantee you will not get sick from the flu or die from it. Recently, the Cochrane Collaboration, an international group that evaluates the evidence for various medical interventions, reviewed the medical literature on the effectiveness of the flu vaccine in preventing death.

Unfortunately, the evidence on how well the vaccine works to prevent death in the elderly is limited. Few of the existing studies are randomized trials -- considered the gold standard for medical evidence. Instead, most data are from observational studies -- studies in which scientists simply count up outcomes (here, the number of deaths that occur among people who did or did not get the vaccine).

But drawing conclusions about cause and effect from such observations is fraught with problems.

For example, a 2003 study published in the New England Journal of Medicine observed that the flu vaccine was associated with a 50 percent reduction in the overall death rate (that is, death from heart disease, stroke, cancer and all other causes combined). To attribute an effect of this magnitude solely to the flu vaccine is ludicrous: Flu-related deaths make up less than 2 percent of all deaths. If the claim were accurate, the vaccine's power would dwarf that of any other medical intervention. There is, however, a much more likely explanation: People who choose to get a flu shot are much healthier -- and therefore already at much lower risk of death -- than people who do not.

Only five randomized trials have examined the effectiveness of the flu vaccine. In these studies, patients were randomly assigned -- a selection technique equivalent to the flip of a coin -- to get either a flu vaccine or a placebo injection. But none of these studies looked at whether the vaccine prevents death. Instead, the scientists measured who developed a flu-like illness. For a summary of the findings of these studies, see "How Well Does the Vaccine Work in the Elderly?" below.

In the absence of good randomized trial data, it is still possible to gauge the effectiveness of vaccination by looking at time trends in flu vaccine rates compared with flu-related deaths in the elderly. As more people get vaccinated, you would expect the flu-related death rate to decline -- if the vaccine is effective. But, as the graph below, titled "A Windening Gap," shows, despite a dramatic increase in vaccination among the elderly, deaths from the flu and pneumonia have hardly budged. (The calculations have taken into account the aging of the population.)

For younger adults, flu-related death is so rare that it has not been reliably studied: Doing so would require a trial of millions of people.

Of course, the flu shot may have benefits besides reducing the chance of death. Many may get flu shots simply to avoid getting sick. The Cochrane Collaboration identified more than 20 randomized trials addressing this question. The overall chance of developing "clinical" flu (we'll explain in a minute) was 19 percent in those chosen, again by chance, to receive the recommended flu vaccine vs. 23 percent in the control groups.

The careful reader may notice that these percentages are substantially higher than those reported for the elderly. (See "How Well Does the Vaccine Work in the Elderly?") This is because clinical flu is defined as a set of non-specific symptoms including fever, cough and muscle aches -- symptoms shared by many non-flu illnesses like the common cold. These non-flu illnesses may be especially common in younger adults because of their exposure to other people, particularly children. To try to isolate the effect of the vaccine, scientists sometimes use laboratory tests to confirm the activity of flu virus in the blood. Using this measure, the chance of flu in the vaccine group is 2 percent vs. 7 percent in the control group.

Studies have also measured another outcome: how vaccination affects days lost from work. On average, there are about 0.16 fewer days lost from work per person vaccinated. Another way of saying this is that about 5 percent of those vaccinated avoid missing about three days of work because of the flu. (That is, 0.16 days divided by the 5 percent who benefited from vaccination equals 3.2 days.) The other 95 percent vaccinated got no benefit.

Take-Home Messages

To promote vaccine use, many in the public health community have overstated the risk of flu-related death and the effectiveness of the vaccine in preventing it. While the flu vaccine may have some important benefit (less flu-related illness), we really do not know whether it reduces the risk of death. For younger individuals -- for whom the chance of flu-related death is extremely small -- any death-protection benefit can only be very modest (and it is unlikely we will ever reliably know whether it even exists). However, we do know that the vaccine reduces the risk of being sick and time lost from work. But because the effect is small, individuals will have to judge for themselves whether it's worth the bother.

We are not suggesting that Americans forgo flu vaccines. We simply want to help people make informed decisions.

For many people, getting the vaccine is a reasonable choice. And many may reasonably choose not to get it. (Consequently, the use of flu vaccination rates by Medicare and others to measure health care quality probably does not make sense.)

Regardless, public health officials should not exaggerate risks or benefits to promote vaccination. Exaggeration carries a price: Not only do some people get scared and engage in behaviors that increase their risk (like waiting in a crowded clinic for a flu shot). They may also grow cynical and end up ignoring health messages that really matter.

Steven Woloshin, Lisa Schwartz and Gilbert Welch are physician-researchers in the VA Outcomes Group in White River Junction, Vt., and faculty members at the Dartmouth Medical School. They conduct regular seminars on how to interpret medical studies. (Seehttp://www.vaoutcomes.org.) The views expressed do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

To respond to this article, send e-mail to health@washpost.com.

August 7, 2005

Beginning at the Beginning

[Updated June 12, 2007]

The following is a summary of the history of thimerosal. It is not a complete list, as there is much more information out there and many more details to the information that I have included, but it hits the high points and gives a good frame of reference for where the discussion of the safety of this product and its relationship to autism and neurodevelopmental disorders should begin.

History of Thimerosal and Autism

  • Invented in the 1920’s by Eli Lilly, thimerosal is 49.6% ethlymercury by weight, a neurotoxin known to be more than a hundreds times more lethal to tissue than lead.



  • Eli Lilly’s safety testing of the product consists of a 1930 study of 22 patients dieing from mengiococcal meningitis in an Indiana hospital. Patients are injected with the solutions and followed until their death, which is within days. Because the patients die of meningitis, they are declared to show no adverse reaction to thimerosal and the product is declared safe for use. Thimerosal is subsequently introduced for use in vaccines and in over the counter remedies as a preservative to kill bacteria in the product.



  • When the FDA is created, Thimerosal is grandfathered in and is not subjected to any additional safety testing. The 1930 study remains the only safety testing done on the substance even after being in use for over 75 years.



  • Through FOIA requests and documents acquired as a part of discovery process in lawsuits against Lilly, it is clear that they have been warned about, and have been aware of the dangers of the product since at least 1947.



  • The use of thimerosal in teething powders for infants leads to a fatal out break of Acrodynia, or “Pink’s Disease”, a form of mercury poisoning. This illness has many symptoms in common with Autism. The link to mercury powders was found in the 1940's and by the 1950's Pink's disease was disappearing.



  • In 1963 Eli Lilly was forwarded an article that read in part: "There is another point of practical significance: does the parenteral injection of thimerosal - containing fluids cause disturbances in thimerosal-sensitive patients?" "It is known that persons that are contact sensitive to a drug may tolerate the same medications internally, but it seems advisable to use a preservative other than thimerosal for injections in thimerosal-sensitive people."



  • On August 17, 1967 the Medical/Science department requests that the claim "non-toxic" on thimerosal labels be deleted in next printing run. Two weeks later the label is changed to "non-irritating to body tissues," and the phrase non-toxic omitted.



  • In 1972 The British Medical Journal reports case of skin burns resulting from the chemical interaction of thimerosal and aluminum. "Mercury is known to act as a catalyst and to cause aluminum to oxidize rapidly, with the production of heat." The manufacturers who supply us with thimerosal have been informed." [Thimerosal is being used in vaccines which also contain aluminum].



  • In the 1970’s six newborns at one hospital die as a result of having a thimerosal containing antiseptic wiped on their wounds.



  • In 1982 the FDA reviews the use of thimerosal. Their statement reads in part: “At the cellular level, thimerosal has been found to be more toxic for human epithelial cells in vitro than mercuric chloride, mercuric nitrate, and merbromim (mercurichrom). "It was found to be 35.3 times more toxic for embryonic chick heart tissue than for staphylococcus areus." [a pathogen that the thimerosal is intended to kill]. A 1950 study showed that thimerosal was no better than water in protecting mice from potential fatal streptococcal infection." "The Panel concludes that thimerosal is not safe for over the counter topical use because of its potential for cell damage if applied to broken skin and its allergy potential. It is not effective as a topical antimicrobial because its bacteriastatic action can be reversed." Additional language added to some Lilly labels: "As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." The FDA orders the withdrawal of over the counter, thimerosal containing products within a 6 month period. It does not order removal from vaccines, but recommends that the issue be studied and that the incidence of neurological problems in unvaccinated populations like the Amish be compared to the vaccinated population. [22 years later no such study has yet been done. On July 19, 2005 Dr. Julie Gerberding, head of the CDC says that such a study would be difficult to undertake because of genetic confounders. This seems contrary to the scientific process because if indeed such a study is done and it is found that the Amish have a lower incidence of neurodevelopmental disorders, the next step would be to undertake genetic studies to see if their genes differ dramatically from the general population and if their differences can help us locate the genetic component of autism. In addition studies designed to see if the small number of vaccinated Amish differ in their risk for NDDs to the larger Amish population would offer information about increased risk from thimerosal.]



  • In the 1930’s the average child only received three vaccines in their young life. Many vaccines are added to the schedule over the years, with an increase in the 1980’s and with 3 vaccines added to the schedule in 1991 alone. The current vaccine schedule calls for 31 vaccines in the first 18 months of life, 48 with full flu vaccination by 72 months of life.



  • A Merck internal memo is obtained during discovery discloses that in 1991 a Merck researcher added up the amount of mercury that is in the new vaccine schedule and sounded an alarm at the company that children who are vaccinated according to it would receive amounts of mercury far and above that considered to be safe by the EPA. Merck takes no action in regard to the information.



  • During the 1990’s, autism rates begin to rise dramatically. Parents complain to the health authorities that they believe that their children’s developmental disorders are related to their vaccines.



  • In 1998, a researcher at the CDC does the same math that Merck did 7 years previously. She finds that children are getting as much as 125 times the EPA limit of mercury for their weight. The EPA limit is based on the ingestion of methlymercury in food by a healthy adult. Because 90% of ingested mercury is excreted in the digestive track and never enters the blood stream, so even the EPA limit may be drastically lacking considering that thimerosal is injected directly into the blood stream and is not subject to the bodies natural defenses against toxic poisoning.



  • In 1999, the CDC and the American Association of Pediatrics issue a joint statement saying that although they find no “evidence of harm” from the mercury exposure that children are getting in their vaccines, they are calling on vaccine manufacturers to remove it from vaccines on a voluntary basis as a precautionary measure because “some children may” get more than the EPA limit for mercury at their 6 month visits. Manufactures begin the process in 1999, but do not remove it from all vaccines.

    No legal ban on thimerosal is issued.

    No recall of the mercury laden vaccines is issued and companies continue to sell lots already manufactured. Some of these vaccines containing full doses of thimerosal have been found in doctors’ offices, by parents who request to read package inserts, with expiration dates as late as 2007.

    No independent or government testing of vaccines is done to confirm that thimerosal has been removed. FDA denies parents request that they set up a system to verify manufacturers claims of low dose or thimerosal free vaccines.

    No statement is issued to pediatricians to alert them to the symptoms of mercury poisoning.

    No recommendation is made to pediatricians to screen children who suffered the onset neurological impairment after vaccination for mercury toxicity.



  • Vaccines with 25mcg of thimerosal are still shipped to developing countries Most flu shots still contain a full dose of thimerosal as of this writing in 2007. (The EPA estimates that a person must weigh 550 lbs. to safely tolerate this amount of mercury.)



  • In November of 1999, the CDC commissions one of its new employees, a Belgian named Thomas Verstraten, to study the Vaccine Safety Datalink to find the risk of autism and other NDDs in relation to thimerosal exposure. Verstraten’s first draft of the study finds a relative risk above 7 for children who receive the highest dose of thimerosal to develop autism. In simple terms, such children have a more than a 600% higher chance of developing autism than children who don’t receive any thimerosal. (A relative risk of 2 is sufficient proof in U.S. courts to find for vaccine injury) Verstraten and other scientists at the CDC spend 4 years trying to change the study so that the relationship between the preservative and NDD’s is significantly reduced or eliminated. The Center for Disease Control will later describe these changes to the study as “improvements”. When the study is published in 2003, it concludes that “no consistent significant associations are found between thimerosal containing vaccines and neurodevelopmental outcomes.” By this time Thomas Verstraten, who is listed as a CDC employee on the study, has been an employee of GlaxoSmithKlein (a defendant in thimerosal law suits) for more than 2 years.



  • In November of 2000, despite being born almost two months prematurely and despite the assurance of my pediatrician that thimerosal had been removed from vaccines, my son Webster is injected with a DTaP vaccine that was 74.5 times the EPA limit for mercury exposure for his weight, just two weeks past his due date. He will go on to develop verbal apraxia and sensory integration disorder.



  • In 2001 Bernard et. al. publish their hypothesis: Autism: A Novel Form of Mercury Poisoning. It reads in part: “Exposure to mercury can cause immune, sensory, neurological, motor, and behavioral dysfunctions similar to traits defining or associated with autism, and the similarities extend to neuroanatomy, neurotransmitters, and biochemistry. Thimerosal, a preservative added to many vaccines, has become a major source of mercury in children who, within their first two years, may have received a quantity of mercury that exceeds safety guidelines. A review of medical literature and US government data suggests that: (i) many cases of idiopathic autism are induced by early mercury exposure from thimerosal; (ii) this type of autism represents an unrecognized mercurial syndrome; and (iii) genetic and non-genetic factors establish a predisposition whereby thimerosal’s adverse effects occur only in some children.”



  • In 2001 the Institute of Medicine is commissioned by the CDC to undertake a comprehensive review of all research into the thimerosal/autism connection. At their first meeting, Dr Stratton, head of the commission, when discussing what the process and product of the working group would be states that, “We said this before you got here, and I think we said this yesterday, the point of no return, the line we will not cross in public policy is to pull the vaccine, change the schedule. We could say it is time to revisit this, but we would never recommend that level. Even recommending research is recommendations for policy. We wouldn’t say compensate, we wouldn’t say pull the vaccine, we wouldn’t say stop the program”. When the transcript of the meeting is made public through a FOIA request, many interpret this to mean that no matter what they find, they will not publicly say that there is any link between the thimerosal and autism. Dr. Harvey Fineberg, head of the IOM, states that this is an incorrect interpretation of the comments, but will not offer any alternate interpretation of what else they could mean.



  • In 2001 Verstraten presents a version of his study to the IOM. He begins his presentation by telling the panel that as of 8 am that morning, he had become an employee of Glaxo Smith Klein. Despite the conflict of interest and the drastic changes made over the course of the study, the IOM will rely heavily on the study in making their determination. Dr. Verstraten returns to Belgium and except for a letter published in Pediatrics, little is heard from him again.



  • In March of 2002 my son Chandler, who was born one month early, is injected with Hepatitis B vaccine containing a “trace amount” of thimerosal (currently still on the schedule), despite the fact that he has no risk factors for Hepatitis B, and he is still two weeks from reaching his due date. Within days he develops fevers and uncontrollable crying that lasts for three months and bowel problems that persist for two years until he is placed on the GFCF diet. He will go on to be diagnosed with both Autism and mercury poisoning at age 2. I later discover that the “trace amount” of thimerosal is still just over the EPA limit of mercury for his weight.



  • In 2003 the Verstraten Study is published in Pediatrics with no mention of the conflict of interest of the lead researcher. Later a private contractor would testify before congress that he was ordered to destroy the original data sets used in the 1999 version of the study that found the dramatic link between thimerosal and autism in the interest of “patient confidentiality”. The entire Vaccine Safety Datalink is eventually moved to an offshore private company and can no longer be accessed by FOIA request.



  • In February of 2004, the IOM rushes to hold public hearings where researchers on both sides of the issues present their studies. The meeting is considered to be a “draw” between the two sides by many of those in attendance. A link is neither proved nor disproved, but new research in to the mechanism of how mercury can trigger autism and NDDs in a genetically vulnerable sub population is presented, along with case studies of successful treatment of autistic symptoms based on the new research.



  • In May of the same year, the IOM issues their final conclusion on the link between Thimerosal and NDDs. They state that, “the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism. The committee further finds that potential biological mechanisms for vaccine-induced autism that have been generated to date are theoretical only.” They then go on to take the unusual step of recommending that research into a link between the two be abandoned and funds be spent on other lines of inquiry. The conclusion relies heavily on Verstraten and several other epidemiological studies that are considered to implement fatally flawed methods and to be riddled with conflict of interest by members of the autism community. Parent groups are enraged. The IOM panel disbands.



  • Later that year, Thomas Verstraten publishes a letter in Pediatrics in response to those who criticize his study and his conflict of interest. His letter does not address the substance of the charges made against the study and the changes that were made to it over it’s 4 year evolution, but instead says that continuing the debate the validity of the 1999 study would be a “waste of scientific energy and not to the benefit of the safety of US children or of all the children world wide that have the privilege of being vaccinated.” He goes on to say that any suggestion of impropriety on the part of himself, the CDC or GSK is an insult and accuses his critics of having “pitiable attitudes”.



  • In July of 2005, in the face of continuing criticism of the IOM findings, the head of the IOM, Dr. Harvey Fineberg, issues a letter stating that Dr. Stratton’s 2001 comments that they would not say “pull the vaccine” or “change the schedule” were taken out of context and did not suggest that the IOM decision was compromised. Dr. Fineberg has not, despite requests, offered an alternative interpretation of what her comments meant in context.



  • In March of 2005, Author David Kirby released his book, “Evidence of Harm - Mercury in Vaccines and the Autism Epidemic: A Medical Controversy” detailing the history of thimerosal in vaccines and its relationship to autism.



  • In April of 2005 the CDC posts a notice on their web site stating that they were in the process of reviewing “Evidence of Harm” and would be responding to the book.



  • In June of 2005 Robert F. Kennedy Jr. echoed the information found in the book and charged the CDC and Eli Lilly of malfeasance in covering up evidence of a causal effect between thimerosal and autism in an article published in Rolling Stone and Salon.com. It is entitled “Deadly Immunity: Robert F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal”.



  • July 19, 2005. The CDC holds a press conference to: “communicate the importance of infants and children receiving their recommended vaccinations on time, and reassure parents that vaccines are safe. The renewed attention to the potential causal link between thimerosal, a vaccine preservative, and autism will also be addressed during the press conference.” Vaccine safety groups are not informed of the press conference nor invited. The conference presents no new information and does not answer important questions raised in Evidence of Harm or Deadly Immunity about the conduct of the CDC the IOM or the reliability of the research that continues to be used to show no link between thimerosal and autism.



  • As of this writing June 26, 2007 the CDC has yet to issue its response to “Evidence of Harm” or to “Deadly Immunity”.



  • In June of 2007 the first vaccinated v. unvaccinated study is finally done... by parents. Generation Rescue funded a survey using the CDC's techniques for determining incidence of a disorder and found that vaccinated children are two and a half times more likely to have a neurodevelopmental disorder. CDC spokesman Curtis Allen said, "We look forward to learning more about the survey," . If the CDC responds to the survey this paper will be updated to reflect their response.



  • On June 25, 2007 Congresswoman Carolyn Maloney (D-NY) introduced the "Comprehensive Comparative Study of Vaccinated and Unvaccinated Populations Act of 2007" (H.R. 2832), legislation that would require the National Institutes of Health (NIH) to conduct a comprehensive comparative study of vaccinated and unvaccinated populations. Her stated purpose is to resolve the controversy about the possible link between autism and mercury or other vaccine components.