AGE OF AUTISM

The Age of Polio: How an Old Virus and New Toxins Created a Man-made Epidemic -- Part 4, Post-War Epidemics and the Triumph of Vaccination

Read Part 3, Making Sense of Campobello; Part 2, A Gypsy Moth Flaps its Wings and Part 1, The Wrong Narrative.

By Dan Olmsted and Mark Blaxill

Life magazine for August 15, 1949, reflected the booming exuberance of the times. The cover, “How to Dress for Hollywood,” featured a buxom starlet in suitably sultry attire. There were ads for DeSotos and Nashes and Chevys to mobilize families and their growing broods of children; cigarettes like Pall Mall, whose “greater length of traditionally fine, mellow tobaccos serves as a longer, natural filter to screen and cool the smoke on the way to your throat”; toothpastes to brush away smoker’s breath and shine stained teeth, and articles on everything from a new sailboat called the Sunfish to a town in Louisiana that cut its taxes in half by installing slot machines.[i]

But twin specters of death and destruction hung over this bright baby-boomer world – the anxiety over atomic annihilation if the Cold War turned hot, and every parents’ most proximate fear for their children, polio.

There were two articles on polio in this August issue. One was titled “Summer season brings epidemics of this uncontrollable disease” and noted that “throughout the nation last week the threat of polio was growing. Starting with some spotty outbreaks during May and June the disease had reached near-epidemic proportions during the sultry drought-ridden month of July. By Aug. 1, 8,300 cases had been reported, a 43% increase over last year. Polio seemed more uncontrollable than ever.”

The peak was still ahead – 1952 would bring 58,000 cases -- but the path to prevention had already accelerated faster than any of the cars on display in Life’s pages in 1949. The year before, John Enders’ research group in Boston had cultivated the poliovirus in human tissue, a Nobel-winning breakthrough that cleared a path for Jonas Salk’s vaccine, which followed in 1955. Successful field trials among several hundred thousand children known as Polio Pioneers were announced on April 12, 1955 – the tenth anniversary of FDR’s death. Church bells rang out across the nation.

The jubilation was justified in terms of the vaccine’s effect on the poliovirus – by 1961, only 161 cases of poliomyeltis were confirmed in the United States, just 29 more than the first epidemic year of 1894. But with the outbreaks ending, basic research withered. As Life noted, “how polio is spread, how the virus enters the body, they do not know.”

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In 1949, the same year as the Life article, Drs. Morton S. Biskind and Irving Bieber published “DDT Poisoning – A New Symptom With Neuropsychiatric Manifestations” in the American Journal of Psychotherapy. “By far the most disturbing of all the manifestations are the subjective reactions and the extreme muscular weakness,” they reported.[ii]

The Age of Polio: How an Old Virus and New Toxins Triggered a Man-made Epidemic -- Part 3, Making Sense of Campobello

Read Part 2, A Gypsy Moth Flaps its Wings and Part 1, The Wrong Narrative.

By Dan Olmsted and Mark Blaxill

Despite its name, the town of Cherryfield in Washington County, Maine, calls itself the Blueberry Capital of the World, and there is no disputing the claim. More than 90 percent of the world’s commercial blueberries are grown in Washington County, and Cherryfield is a major processing and shipping center. Machias, the county seat, hosts the annual Blueberry Festival every August. The festival puts on a musical, this year titled “Blueberry Fields Forever,” and a pie-eating contest – blueberry, of course.

The area has a couple of other claims to fame. Washington County hugs the Atlantic Coast where the United States meets Canada, the easternmost point in the United States; the city of Eastport is the first to see the sunrise. The region is known as Down East.

[A Map of Washington County Maine, also known as Sunrise County, with Cherryfield and Campobello circled. Click photo to enlarge.]

Two miles offshore is the island of Campobello, part of New Brunswick, Canada, where Franklin D. Roosevelt and his family spent summers. It was on his “beloved island” in August, 1921 – ninety years ago – that Roosevelt was afflicted with a paralytic illness diagnosed as poliomyelitis.

But this remote and lightly populated area already had a significant history with polio – one of the first clusters in the United States occurred in Cherryfield a quarter-century earlier, in 1896 (we cited it in our list of pre-1910 outbreaks with links to fruits and vegetables). Seven children were affected, and one died. In all the discussion and theorizing about Roosevelt’s illness over the intervening decades, this convergence has been overlooked.

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Roosevelt arrived at Campobello on Sunday afternoon, August 7, on the yacht of a friend who sailed him up from New York City. The previous week, Roosevelt had visited a Boy Scout camporee on Bear Mountain, N.Y., not far from the family’s Hudson River home in Hyde Park.[i]

At the dock, his family was waiting. His children played on the yacht through the adults’ cocktail hour, then were taken home while Franklin and Eleanor stayed for an elegant dinner on the fantailed aft deck, served by uniformed stewards.

Three days later, on Wednesday, August 10, Roosevelt went to bed early in the cranberry-red cottage on Campobello Island, unusually tired and suspecting “a slight case of lumbago” (lower back pain). He had chills during the night, and in the morning one of his legs was weak; the paralysis had begun. By the next night, both legs were paralyzed.

Because of the defining role it played in his life and, inevitably, world history, the days leading up to the attack have been dissected in detail by Roosevelt’s multiple biographers. Most historians believe he contracted the poliovirus on his visit to the Boy Scouts, which would have multiplied the chances of exposure to a youth with an active infection. Alternatively, he could have come down with the virus sometime between the Bear Mountain trip and his departure for Campobello.

After his arrival at Campobello, much has been made of a fall overboard while sailing in the Bay of Fundy; of his typically energetic activities on the day he first felt ill, which included putting out a small forest fire on a nearby island and going for a dip with his children in a freshwater pond near his house. The “paralyzingly cold” water of the Bay of Fundy became an ominous metaphor for what was about to happen, but was never a serious biological argument.

The Age of Polio: How an Old Virus and New Toxins Triggered a Man-made Epidemic -- Part 2, A Gypsy Moth Flaps Its Wings

Read Part 1, The Wrong Narrative Here.

By Dan Olmsted and Mark Blaxill

Etienne Leopold Trouvelot arrived in the United States from France in the late 1850s and settled into his brand new house at 27 Myrtle Street in Medford, a suburb of Boston. A self-taught scientist and later an astronomer affiliated with Harvard, his interest alighted first on insects, and he turned the land adjoining his home into a virtual boarding house for bugs.

“To contain his hordes of larvae he constructed a stupendous barricade to encircle his grounds – a wooden fence eight feet high that encompassed his full five acres of shrubs and small trees,” writes author Robert J. Spear. “Netting was stretched from the perimeter of the fences across the trees and was supported in the middle on posts, making it possible for Trouvelot to walk upright through his specialized insectary.”[i]

A decade later, he acquired a handful of gypsy moths, probably on a trip back to France – there were none in the United States. What happened next can be deduced from the title of Spear’s book, The Great Gypsy Moth War. Inevitably, insects escaped, not least because birds continually pecked their way into what they viewed as a very large diner.

The gypsy moths did not make their presence known outside the “stupendous barricade” for about a decade, but when they did, the results were apocalyptic. Lacking natural predators, they denuded trees – especially fruit trees – in what seemed like a single collective gulp. Then they crawled onward and upward. “Citizens could only stare in disbelief as the dirt streets became carpeted with millions of larvae across Myrtle Street,” writes Spear, “turning its surface black with the bodies of fast-moving caterpillars.”

Horrified residents combed gypsy moth larvae out of their hair, shoveled them off the steps, stomped them underfoot and burned huge clusters in noxious kerosene fires. But humans were simply outmatched. The Hellstrom Chronicles, the 1970s movie that suggested insects would inherit the earth, was coming alive in suburban Boston.

The Age of Polio: How an Old Virus and New Toxins Triggered a Man-Made Epidemic -- Part 1, The Wrong Narrative

By Dan Olmsted and Mark Blaxill

Polio is the iconic epidemic, its conquest one of medicine’s heroic dramas. The narrative is by now familiar: Random, inexplicable outbreaks paralyzed and killed thousands of infants and children and struck raw terror into 20^th century parents, triggering a worldwide race to identify the virus and develop a vaccine. Success ushered in the triumphant era of mass vaccination. Now polio’s last hideouts amid the poorest of the poor in Asia and Africa are under relentless siege by, among others, the Bill & Melinda Gates Foundation. Eradication is just a matter of time, and many more illnesses will soon meet the same fate.

But based on our research over the past two years, we believe this narrative is wrong – and wrong for reasons that go beyond mere historical interest. The misunderstanding of polio has warped the public health response to modern illnesses in ways that actually make them harder to prevent, control, and treat.

The reality, we believe, is that the virus itself was just half the epidemic equation -- necessary but not sufficient to create The Age of Polio. Outbreaks were not caused solely by poliovirus – the microbe was an ancient and heretofore harmless intestinal bug -- but by its interaction with a new toxin, most often innovative pesticides used to treat fruits and vegetables.

This alternative narrative makes better sense of the natural history of polio, and it resolves a number of anomalies that remain to this day. It suggests why poliomyelitis outbreaks emerged, evolved, and exploded the way they did; it probably solves, for the first time, the enduring riddle of why Franklin D. Roosevelt was afflicted 90 years ago this summer on Campobello Island; and it may mean today’s billion-dollar-a-year eradication effort is misguided, if not downright quixotic.

These are large claims. Let us explain.

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Polio was a strange illness, never fully understood even by those who devoted their lives to studying and subduing it. It was a summer plague, coming on in late spring and all but vanishing in the fall. Many thought contagion had something to do with water, and Americans kept their children away from swimming pools in droves.

There is a profound distinction between poliovirus – an enterovirus, one that enters through the mouth and takes up residence in the GI tract and bloodstream – and poliomyelitis, the paralytic form of the illness. In the vast majority of cases, the virus causes either a minor illness or an inapparent infection.

But in 1 or 2 in 100 cases, the virus somehow gets past multiple defenses and into the nervous system, where it finds its way to the anterior horn cells at the top front of the spinal column. There, it preferentially attacks the gray-colored motor neurons (polio means gray in Greek) and causes inflammation of the protective myelin sheath (myelitis). This interferes with nerve signals to the muscles and can lead to temporary or permanent paralysis of the limbs and the respiratory system. A small number of people who contract poliomyelitis -- on the order of 1 percent -- die.

The first recorded U.S. outbreak was in 1841 in West Feliciana, Louisiana (10 cases, no deaths). There was a half-century gap until the next cluster, in 1893 in Boston (26 cases, no deaths). Then, in 1894, came what is widely regarded as the first major epidemic, in Rutland and Proctor, Vermont (132 cases, 18 deaths). Thirty more outbreaks – from such seemingly disparate locations as Oceana County, Michigan, and California’s Napa Valley -- were reported in the United States through 1909. The worst by far was New York in 1907, with 2,500 cases and a five percent mortality rate, a harbinger of the 1916 epidemic in the Northeast that killed 2,000 in New York City alone.[i]

Mark Blaxill on Fox & Friends RE: Gardasil Mandates

Mark Blaxill appeared on Fox & Friends yesterday. Please read his series, "License to Kill" about Merck, the Federal Government and how Gardasil was brought to market HERE. You may recall that the former head of the CDC (Dr. Julie Gerberding) became head of Merck's Vaccine Division upon leaving her government job.

“The Age of Autism” Debuts in Paperback as the Battle for the Truth Escalates

By Dan Olmsted and Mark Blaxill
 
Eighty years ago today – on Sept. 13, 1931 – a girl known only as Virginia S. was born. She became the oldest child in a landmark medical paper by Leo Kanner titled, “Autistic Disturbances of Affective Contact,” describing Virginia and 10 other children with a new syndrome that became known as autism.
 
By happenstance – our publisher picked the date, not us – today is the launch of the paperback edition of our book first published a year ago, “The Age of Autism – Mercury, Medicine, and a Man-made Epidemic.”
 
The convergence serves to make the main point in our book – that autism is a new disorder, that it arose within the span of a human lifetime, that it is therefore fundamentally an environmental illness, and that in order to prevent and treat it, medicine needs to understand that and act with urgency.
 
The past year has taken us around the country – from Minneapolis and Dallas to Visalia and Atlanta – and we have met many people who share our vision of The Age of Autism. One direct result has been the creation of the Canary Party that seeks to end medical corruption and force a reckoning with the root causes of so much chronic illness and developmental disability.
 
A number of other events this year have helped underline the theme of our book and undercut the paradigm of autism as an untreatable genetic illness– but not without the resistance of a rearguard whose livelihood and reputations depend on clinging to the old model.
 
Most astonishing, the basis for the claim that autism is mostly genetic crumbled like the Berlin Wall. As one of us wrote in July,

“For over two decades now, so-called 'autism experts' have been claiming that autism is more than 90% caused by genes. The influence of these claims on autism policy and research funding is hard to overstate. But few realize that the basis of these claims hangs on a fragile evidence base: two small twin studies--one from Great Britain, the other from Scandinavia--that reported high rates of concordance for autism among identical twins and no concordance at all among fraternal twins. Last week, the largest and most rigorous twin study ever conducted, the California Autism Twin Study (CATS) reported contradictory new evidence that struck a devastating blow to these claims. The CATS identical twins had lower and the fraternal twins higher concordance rates than past studies, a striking finding that suggests that instead of being highly heritable, the vast majority of autism cases stem from environmental causes.

Rick Perry and The Conflicts of Government Licensed Corporate Profit: Merck & Gardasil

Last Spring, Mark Blaxill authored three posts about Merck's Gardasil HPV vaccine and the symbiosis of government and commerce. Texas Governor Rick Perry is in the news not only for his Presidential bid, but his close relationship with Merck, including  an attempt to mandate Gardasil for Texas girls in 2007. An attempt that fell flatter than a Longhorn steer's cow patty. An attempt that he now says was a big mistake.  According to The Washington Post, Perry's conflicts of interest were myriad:

"Merck could generate billions in sales if Gardasil _ at $360 for the three-shot regimen _ were made mandatory across the country. Most insurance companies now cover the vaccine, which has been shown to have no serious side effects.

The New Jersey-based drug company is bankrolling efforts to pass state laws across the country mandating Gardasil for girls as young as 11 or 12. It doubled its lobbying budget in Texas and has funneled money through Women in Government, an advocacy group made up of female state legislators around the country.

Perry has ties to Merck and Women in Government. One of the drug company's three lobbyists in Texas is Mike Toomey, Perry's former chief of staff. His current chief of staff's mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for Women in Government.

The governor also received $6,000 from Merck's political action committee during his re-election campaign.

A top official from Merck's vaccine division sits on Women in Government's business council, and many of the bills around the country have been introduced by members of Women in Government.

Merck spokeswoman Janet Skidmore would not say how much the company is spending on lobbyists or how much it has donated to Women in Government. Susan Crosby, the group's president, also declined to specify how much the drug company gave."

Some folks are calling Gardasil mandates into question because HPV is a sexually transmitted disease, thus a social issue, especially for Conservatives. Blaxill dissects the argument from a more logical point of view. In short, the Perry/Gardasil issue isn't about teen promiscuity, it's about:

• A vaccine that hasn’t yet saved a life and won’t have a chance to test the theory that it does for years
• A vaccine that’s already killed and disabled children
• A vaccine that generated billions in revenue and profit for Merck within months.
• A vaccine the FDA gave a free pass on safety without testing against a true placebo
• A vaccine the CDC couldn’t wait to recommend without testing or questioning any of the assumptions above
• A CDC leader named Julie Gerberding who was responsible for recommending Gardasil as safe and effective and then waited the minimum number of days before passing through the revolving door to taking responsibility for managing the sales and profit of the same vaccine.  Read the three part series in full below.

By Mark Blaxill

Part 1 A License to Kill? How A Public-Private Partnership Made the Government Merck’s Gardasil Partner
 
“Perhaps no other recent product on the market demonstrates successful health care technology transfer better than the human papillomavirus (HPV) vaccine, Gardasil, produced by Merck & Co. and approved by the FDA in June 2006,” proclaimed a recent National Institutes of Health (NIH) newsletter. In a February 23, 2007 article entitled “From Lab to Market: The HPV Vaccine”, the NIH Record celebrated the pivotal role of government researchers in developing Merck’s Gardasil product. “Based largely on technology developed at NIH,” the newsletter reported, “the vaccine works to prevent four types of the sexually transmitted HPV that together cause 70 percent of all cervical cancer and 90 percent of genital warts (HERE).
 
The occasion motivating this celebratory article was the “Philip S. Chen, Jr. Distinguished Lecture on Innovation and Technology Transfer” given by Douglas T. Lowy, one of the NIH scientists involved in developing the HPV vaccine. In the ceremony pictured above, Lowy is receiving an honorary poster from the head of NIH at the time, Elias Zerhouni, who took advantage of the occasion to shower praise on his team’s work, one he viewed as a model for future efforts. “It’s a ‘heroic’ story about the effort to fight cervical cancer, the second most deadly cancer for women worldwide, said NIH director Dr. Elias Zerhouni,” in the NIH Record’s account. “He noted that he has talked about the vaccine’s creation to Congress and with the President on his recent visit to NIH. How researchers took the technology ‘from the lab to the marketplace is a journey we can learn from,’ Zerhouni said.”
 
While Zerhouni was bragging to anyone in Washington D.C. who would listen about the NIH team’s role in this historic accomplishment, the vaccine's developers were actively spreading the news of their achievement in scientific circles. It’s hard to blame them, because at the time Lowy and his colleague John T. Schiller, leaders of the team that had invented the technology for the “virus-like particles” (or VLPs) that made Gardasil possible, were in some pretty heady company. In 2008, Harald zur Hausen, the scientist who discovered the role of human papillomavirus (HPV) in cervical cancer during the 1980s, received one half of the Nobel Prize in Medicine; the two researchers at the Pasteur Institute who had discovered the human immunodeficiency virus (HIV) had to share the other half.

An Elaborate Fraud, Part 4: News Analysis -- The British Medical Association Is “Standing Up for Doctors” Even If It Means Attacking Patients

By Mark Blaxill

If you go to the web-site of the British Medical Association you will find the BMA’s tag line prominently displayed: “Standing up for doctors.” It’s a position most notable for what they do not stand up for: not patients, not science, not health, just the doctors who join the association. The home page elaborates what this means more directly, “We are … an independent trade union dedicated to protecting individual members and the collective interests of doctors.”

In other words, The BMA is an unabashed economic entity: a trade union. And its primary purpose is to defend the money and power of its members. It’s that simple. Who does the BMA stand against? The adversary of the day might vary a bit. But on a day to day basis, the biggest conflicts British doctors face are with patients. When patients comply with what doctors tell them to do and generate income for them, they are useful to the BMA. When they want to take control of their own families’ health, or worse, suggest that member doctors may have caused harm, well that’s a different matter. When patients' interests conflict with “standing up for doctors,” It’s pretty clear what the BMA’s job is.

The BMA attacks critical patients as if they were their enemy.

One of its instruments for defending doctors’ interests is “science,” or more accurately, propaganda masquerading as science. Notably, the BMA publishes the British Medical Journal, the journal that earlier this year disseminated Brian Deer’s accusations of fraud against Andrew Wakefield. Despite Wakefield’s lengthy and Byzantine trial on allegations surrounding his medical ethics and research design in front of the General Medical Council (GMC), allegations of scientific fraud were not part of the GMC proceedings. Until January 2011, freelance reporter Brian Deer, and Deer alone, had accused Wakefield of lying about data and falsifying evidence. That is, until the BMJ entered the mix, effectively certifying the validity of Deer’s 2009 accusations in The Sunday Times with a dramatic flourish that proved even more devastating to Wakefield’s reputation than the GMC trial. How devastating were these accusations? In a press release, BMJ editor Fiona Godlee claimed to be “struck by a comparison between researcher Andrew Wakefield’s fraud and Piltdown man, that great paleontological hoax that led people to believe for 40 years that the missing link between man and ape had been found.” Sadly, these extravagant allegations were picked up by the global media, spread like wildfire, and, despite their manifest implausibility, the charges stuck.

For any doctor or scientist who might ever have been inclined to support a critical patient the message was clear: when the BMA and its flagship journal the BMJ go after you, they will be ruthless.

Lost in the frenzy over Wakefield’s alleged scientific fraud, however, is the fact that the origin of the evidence in the 1998 Lancet article never came from Wakefield.  Rather, the Royal Free Hospital's investigation (which included many others beyond Wakefield) was launched based on the collection and reporting of observations originally made by parents. These parental observations included varying forms of regressive autism or encephalitis, inflammatory bowel disease and a temporal association between exposure to the measles-mumps-rubella vaccine (MMR) and the onset of symptoms. As time has passed (and in every one of the cases reported in The Lancet paper), the parents’ continuing reports support Wakefield’s original account. In addition, many thousands of parents have subsequently reported an identical sequence of events. At kitchen tables all over the world, the MMR has become known as “the autism shot.” The heart of the matter, therefore, is the tension between the British medical establishment on one hand and the Lancet parents on the other.

So in accusing Wakefield, the BMJ is really doing something else; they are accusing the Lancet parents of committing an elaborate fraud.

Why would the BMJ condone such an aggressive attack? Sadly again, in publishing Deer’s accusations, the house organ of the BMA was advancing the interest neither of science nor the truth. Instead, they were “standing up for doctors”: for the income doctors gain from frequent visits to the doctor to receive vaccination; for doctors’ freedom to avoid costly minutes with skeptical parents during their well-child visits; and for the power of doctors to force parents to comply with the recommended vaccination schedule.

As for Deer’s reporting, while Wakefield provided the proximate target, not far under the surface lurked an aggressive attack on parents who have the temerity to question the mandates of the BMA and public health officials. It’s quite a ruthless attack: Parents who question vaccine safety are a danger to the public health; Parents who allege vaccine injury are liars; Parents who take offense to intimidation and coercion are anti-vaccine campaigners; Parents who seek resources to support a vaccine-injured child are cheating the system to get rich.

This kind of attack is not delicate work. But in making the decision to tie its reputation to Deer’s, the BMA made a risky choice.

One need not look very far to find evidence of Deer’s boorishness. It’s most plainly exemplified by his unvarnished contempt for noncompliant parents. One widely circulated example was provoked following on-line challenges to Deer’s reporting by three autism parents: Lancet 12 mother Isabella Thomas, Age of Autism Contributing Editor John Stone and a third unnamed blogger. Jumping into the fray in a Pharma-friendly blog, Deer had this to say about the critical parents (see HERE)

And they wonder why their children have problems with their brains.

Apparently not content with just this brief insult, Deer elaborated further (see HERE )

Part 3: Vaccines and Autism - What Do Epidemiological Studies Really Tell Us?

(Managing Editor's Note: Read Part 1and  Part 2. Also, this report is available in in full .pdf (Vaccines and Autism Epidemiology HERE)

“We have 16 studies already that clearly state that vaccines do not cause autism.”

-- Amy Pisani, Executive Director, Every Child By Two

“16 studies have shown no causal association between vaccines and autism, and these studies carry weight in the scientific industry.”

-- Dr. Nancy Snyderman, NBC Today Show Medical Editor

“The science is largely complete. Ten epidemiological studies have shown MMR vaccine doesn’t cause autism; six have shown thimerosal doesn’t cause autism.”

-- Dr. Paul Offit, “Autism’s False Prophets”

----------------------------

A NOTE FROM SAFEMINDS:

There are 16 epidemiological studies here on MMR vaccines, thimerosal and autism. These studies represent the most often cited papers by scientists, public health officials and members of the media when trying to refute any evidence of an association between vaccinations and autism.

There are serious methodological limitations, design flaws, conflicts of interest or other problems related to each of these 16 studies. These flaws have been pointed out by government officials, other researchers, medical review panels and even the authors of the studies themselves. Taken together, the limitations of these studies make it impossible to conclude that thimerosal and MMR vaccines are not associated with autism.

SafeMinds would like to acknowledge the previous work in this regard gathered by the “Fourteen Studies” project at Generation Rescue: http://www.14studies.org/about.html

One additional study on autism and thimerosal was published in September 2010 while this paper was in completed draft form. This study’s methods produced a result that demonstrated that thimerosal exposure was protective against autism. Further analysis of this study is forthcoming but not included here.

PART 3

FLAWS AND LIMITATIONS OF THIMEROSAL-AUTISM EPIDEMIOLOGY STUDIES

There has only been one major scientific review of the main epidemiological studies to examine a potential association between thimerosal containing vaccines (TCVs) and autism spectrum disorders: The Institute of Medicine Immunization Safety Committee Report, issued in May, 2004.[37]

The IOM report focused almost exclusively on large, population-based epidemiological studies based on health records. The committee chose to minimize the importance of several biomedical thimerosal studies conducted in laboratories and animal models. Today, a much larger body of medical literature has been amassed which clearly demonstrates the powerful neurotoxic effects of thimerosal. These are joined by other studies demonstrating the increased risks of simultaneous administration of certain vaccines on the current childhood schedule.

WHAT THE IOM CONSIDERED:

The IOM committee reviewed epidemiological studies examining TCVs and autism, including three controlled observational studies (Hviid et al., 2003; Miller, 2004; Verstraeten et al., 2003) and two uncontrolled observational studies (Madsen et al., 2003; Stehr-Green et al., 2003). The published papers “consistently provided evidence of no association between TCVs and autism, despite the fact that these studies utilized different methods and examined different populations (in Sweden, Denmark, the United States, and the United Kingdom),” the committee wrote.

IOM MAIN CONCLUSIONS:

■ “Based on this body of evidence, the committee concludes that the evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism.”

■ “In the absence of experimental or human evidence that vaccination (either the MMR vaccine or the preservative thimerosal) affects metabolic, developmental, immune, or other physiological or molecular mechanisms that are causally related to the development of autism, the committee concludes that the hypotheses generated to date are theoretical only.”

LIMITATIONS OF THE IOM REVIEW:

■ Because the “vast majority” of ASD cases cannot be accurately sub-classified, “if there is a subset of individuals with autism syndrome triggered by exposure to vaccines, our ability to find it is very limited in the absence of a biological marker.”

■ In fact, the committee admitted, trying to find a cause of autism using population-based epidemiological analyses “requires either a well-defined at-risk population or a large effect in the general population.”

■ But without any known biomarkers, well-defined risk factors, or large effect sizes, “the committee cannot rule out, based on the epidemiological evidence, the possibility that vaccines contribute to autism in some small subset or very unusual circumstances.”

NOTE: Knowledge of biomarkers and risk factors in ASD has increased considerably since the release of the 2004 IOM report.

CRITIQUES OF THE IOM REVIEW

Mark D. Noble, PhD - Professor of Genetics and of Neurobiology and Anatomy, University of Rochester Medical Center [38]

It is easy to understand why people are not believing the scientific community. It reduces confidence in the scientific enterprise when it turns out that the CDC had information on early versions of the studies of Verstraeten et al. that demonstrated a linkage between thimerosal exposure and autism, that these studies were never published, and that no one has ever explained satisfactorily why different analyses were conducted and why they were changed. But all of these studies have equally debilitating flaws that invalidate any conclusions drawn from them on thimerosal safety. And if it turns out that that there is a subset of children for whom additives in vaccines are a problem, then this is important to know. For then we can focus on how to identify these children in advance. The conclusions I have drawn are that we are not going to solve this problem by ignoring it. So let’s embrace it. Let’s get the data.

Irva Hertz-Picciotto, PhD, MPH, Chief of the Division of Environmental and Occupational Health, University of California, Davis School of Medicine –[39]

Several large studies finding no association are far from robust, as they suffer from numerous biases that seriously limit their definitiveness. These include: noncomparable sources for ascertainment of cases, uncontrolled confounding, unrepresentative sample due to selective exclusions, and an as-yet unexplained pattern whereby children with earliest vaccines are the least likely to have developmental deficits. Thus, the body of evidence at this point is inadequate to draw conclusions… Several investigations have been ecologic studies, widely known to be the weakest possible epidemiologic design. Even restricting discussion to the individual-level designs, published studies conducted in Denmark, the UK, and the US are characterized by serious, even fatal, flaws. To regain the confidence that we in the medical/public health/scientific community need in order to fulfill our mandate to protect health, we cannot avoid facing these tough scientific questions head-on. This means funding solid scientific research into vaccines, thimerosal, and the related issues of susceptibility at the population level.

Richard Deth, PhD, Professor of Pharmacology, Northeastern University – [40]

Part 2: Vaccines and Autism - What Do Epidemiological Studies Really Tell Us?

(Managing Editor's Note: We ran Part 1 earlier this week. this report is available in in full .pdf (Vaccines and Autism Epidemiology HERE)

“We have 16 studies already that clearly state that vaccines do not cause autism.”

-- Amy Pisani, Executive Director, Every Child By Two

“16 studies have shown no causal association between vaccines and autism, and these studies carry weight in the scientific industry.”

-- Dr. Nancy Snyderman, NBC Today Show Medical Editor

“The science is largely complete. Ten epidemiological studies have shown MMR vaccine doesn’t cause autism; six have shown thimerosal doesn’t cause autism.”

-- Dr. Paul Offit, “Autism’s False Prophets”

----------------------------

A NOTE FROM SAFEMINDS:

There are 16 epidemiological studies here on MMR vaccines, thimerosal and autism. These studies represent the most often cited papers by scientists, public health officials and members of the media when trying to refute any evidence of an association between vaccinations and autism.

There are serious methodological limitations, design flaws, conflicts of interest or other problems related to each of these 16 studies. These flaws have been pointed out by government officials, other researchers, medical review panels and even the authors of the studies themselves. Taken together, the limitations of these studies make it impossible to conclude that thimerosal and MMR vaccines are not associated with autism.

SafeMinds would like to acknowledge the previous work in this regard gathered by the “Fourteen Studies” project at Generation Rescue: http://www.14studies.org/about.html

One additional study on autism and thimerosal was published in September 2010 while this paper was in completed draft form. This study’s methods produced a result that demonstrated that thimerosal exposure was protective against autism. Further analysis of this study is forthcoming but not included here.

PART 2

FLAWS AND LIMITATIONS OF MMR STUDIES

Major Reviews – There have been at least two major reviews of the main studies claiming to examine a potential association between MMR vaccine and autism spectrum disorders. They are the 2005 Cochrane Review and the 2004 Institute of Medicine Immunization Safety Committee Report.

1) The Cochrane Review: “Vaccines for measles, mumps and rubella in children.” October 2005.[1]

According to their sponsors, the Cochrane Reviews report on published (and sometimes unpublished) studies which investigate the effects of interventions for prevention, treatment and rehabilitation in a healthcare setting. Most Cochrane Reviews focus on randomized controlled trials, but other types of evidence may also be taken into account.  The reviews are considered by most experts to provide the gold standard of evidence-based medical science.

In 2005, Cochrane published a review of published studies on the safety and efficacy of MMR vaccine. Their search revealed more than 5,000 papers on the subject, though only 139 of them “possibly satisfied” the reviewers’ inclusion criteria. In the end, they reported on and summarized about 31 studies, only a few of which pertained to autism spectrum disorders (ASD).

Main results - MMR was “likely to be associated” with febrile convulsions within two weeks of vaccination, but “unlikely to be associated” with Crohn's disease, ulcerative colitis, mumps or autism.

General Limitations: the authors concluded that: 

■ There was a moderate-to-high probability of bias in all but one of the cohort studies.

■ The internal validity of some studies was problematic, and the presence of selection, performance, attrition, detection and reporting biases influenced the reviewers’ confidence in these findings. The most common type of bias was selection bias.  

■ There was only limited evidence of MMR’s safety compared to single component vaccines from studies with a low risk of bias. The few studies least likely to be affected by systematic error pointed to a likely association with increased febrile convulsions in the first two weeks post-vaccination.  

■ The cohort studies’ conclusions “that MMR is ‘safe,’ ‘equally safe,’ ‘well-tolerated,’ or has ‘low-reactogenicity,’ need to be interpreted with caution given the potential for confounding.

■ In the cohort studies, the validity of the conclusions was affected by selective reporting in the comparative analysis, with just over half the responses from participants in some cases.

■ There was a lack of clarity in reporting and systematic bias which made it “impossible” to compare the various studies through quantitative synthesis of data.

■ There were general difficulties in ascertaining adequate numbers of unexposed children due to the high uptake of vaccines and the extent of vaccination programs. This is a methodological problem likely to be encountered in all comparative studies of established childhood vaccines.   

■ There was a “lack of adequate description of exposures (vaccine content and schedules)” in all cohort studies.    

■ The failure of any study to provide descriptions of all outcomes was a recurring problem.  

■ Some reports offered inadequate explanations for missing data, accepting as ‘adequate’ explanations such as ‘nonresponse to questionnaire’ and ‘medical records unavailable’.

■ The external validity of the studies was low. Descriptions of the study populations, response rates, vaccine content and exposure - all important indicators of generalizability - “were poorly and inconsistently reported.”  

■ There were inadequate and inconsistent descriptions of reported outcomes, limited observation periods (maximum 42 days) and selective reporting of results. All of these problems contributed to the reviewers’ decision not to attempt pooling data by study design

SUMMARY – Although the reviewers determined that MMR vaccine was “unlikely to be associated” with autism, they concluded that “meaningful inferences from individual studies lacking a non-exposed control group are difficult to make.” They added that there were disappointed by their inability to identify effectiveness studies with population or clinical outcomes.

Many critics question how the authors of Cochrane’s MMR Review could find an “unlikely” association with autism when - in the very same paper - they also concluded that:

(a)   the design and reporting of safety outcomes in MMR vaccine studies, are largely inadequate and

(b)  that critical design and reporting flaws need to be improved and standardized definitions of adverse events adopted.

Sallie Bernard, of SafeMinds, wrote that the Cochrane Review “gives MMR a free pass.” She said the review “Assumes that this version of vaccine is as safe as can be, and so beneficial there is no need to worry about the fact that the safety studies are inadequate. Would this happen for any other drug?  Isn’t it possible, even probable, that the vaccine is effective but still has safety lapses and could be improved?”

In a review presented at the International Meeting for Autism Research (IMFAR) Carol Stott, a UK epidemiologist and Chartered Psychologist, wrote that, given the Cochrane Review’s conclusions, it is important to examine the extent to which the various clinical and population studies have been designed appropriately and with specific reference to the original hypothesis and, thus, to examine the extent to which claims of the hypothesis being refuted or supported are valid.

2) Institute of Medicine, “Immunization Safety Review: Vaccines and Autism.” May, 2004[2]

In February 2004, the IOM’s Immunization Safety Committee held a hearing on the possible association between MMR, thimerosal and autism. The committee reviewed all published and unpublished epidemiological studies on causality as well as potential biologic mechanisms to explain a possible vaccine-autism causal association. Its findings were released in a May, 2004 report. The committee’s conclusions hold wide sway over many scientists, physicians and much of the media to this day.

Main Results: The committee concluded that the body of epidemiological evidence “favor” rejection of a causal relationship between the MMR vaccine and autism,” further stating that studies examining the association between MMR and autism consistently showed evidence of no association between the MMR vaccine and autism.

Limitations:

■ Because the “vast majority” of ASD cases cannot be accurately sub-classified, if there is a subset of individuals with autism syndrome triggered by exposure to vaccines, our ability to find it is very limited in the absence of a biological marker.

■ Although there is no convincing evidence to date that a clearly defined subgroup with susceptibility to MMR-induced autism has been identified, genomics and proteomics could reveal in the future whether or not any genetic susceptibility to vaccine-induced autism exists.

■ A lack of unexposed children is another limitation. The committee noted that they had previously called for studies to enroll children whose families opted against the MMR vaccine, but so far, this type of study has been difficult to do with sufficiently large numbers.

■ The committee also noted that its 2001 report did not exclude the possibility that MMR “could contribute to autism in a small number of children because the epidemiological studies lacked sufficient precision to assess rare occurrences.”

■ They also noted that it was possible that epidemiological studies would not detect a relationship between autism and MMR vaccination in a subset of the population with a genetic predisposition to autism.

The latter two points are covered in the introduction to this document. While the points are well received, it is important to note that ‘epidemiological’ studies lack neither precision nor accuracy simply by virtue of them being ‘epidemiological’. It is entirely possible to design population based studies to maximize the likelihood of identifying small effect sizes; the fact that this hasn’t yet been achieved in the vaccine-autism debate is the fault of the workmen, not the tools. 

SUMMARY: The IOM Committee gave far more emphasis to epidemiological (population based) studies than biological studies, such as clinical studies in children, laboratory studies, and animal model studies. Since the IOM report was released in May, 2004, a large amount of biological data have been generated from several published studies to support an association between vaccines – including MMR - and ASD. A new IOM review that includes these studies is needed.

INDIVIDUAL MMR STUDIES