Monday, November 18, 2002

ACTION ALERT –See Below

RESEARCH

* Harvard – Mass Gen Hospital to Clinical Research Autism Treatment

* Karyn Seroussi's List of Autism-Bio Studies

* Help for Autism – Another Research Summary

* Mercury Dental Fillings Said Safe

* Academia Fails To Protect Research From Industry Bias

* Are Environmental Agents Behind The Autism Epidemic?

COMMENTARY

* Homeland Hijinks And White House Whitewash: Neal Regush

ACTION ALERT

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RESEARCH

Harvard – Mass Gen Hospital to Research Autism Treatment

Harvard University And Massachusetts General Hospital are collaborating on a study to establish a medical protocol for the treatment of autism.

They have already made significant medical observations in treating over 600 children with autism.

Even though autism has reached epidemic proportions, affecting more than 600,000 children in this country and millions of children worldwide, the medical community lacks the scientific data necessary to medically treat these children.

Without this research or similar research, autism will continue to be viewed and treated as just a neurological dysfunction.

Tragically, its victims will continue to suffer, untreated, with severe, biological illnesses.

The Harvard-Mass General study is remarkably the first major study being conducted to establish a medical basis for the treatment of autism.

Twenty years ago, doctors considered autism an “untreatable condition."

In many cases a diagnosis of autism ultimately sentenced a child to an asylum.

According to Time Magazine, May 6, 2002, “the latest studies, (however), suggest that as many as 1 in 150 kids age 10 and younger may be affected by autism or a related disorder."

The problem of the rising rate of autism is compounded by the lack of knowledgeable medical treatment.

The dilemma for physicians is not having a medical care protocol based on valid research data to treat autism.

Doctors are also faced with a group of children from whom it is very difficult to obtain a description of what is wrong with them.

Many autistic children are nonverbal and have behavioral problems so that the physician cannot trust their response.

Unless a treatment protocol is developed, many of these children will live with painful, undiagnosed medical conditions that will grow more serious as they become teenagers and adults.

The success of the Harvard-Mass General study holds out hope to millions of children with autism of receiving the standard of medical care that they need.

The Harvard-Mass General researchers have already had significant findings.

Dr. Tim Buie, a pediatric gastroenterologist from Harvard Mass General, has performed more than 500 gastrointestinal endoscopies with biopsies on autistic children.

His findings show that more than half of these children had treatable gastrointestinal problems that ranged from moderate to severe including esophagitis, gastritis and enterocolitis along with the presence of lymphoid nodular hyperplasia.

In a recent conference Buie echoed the opinion of a growing number of clinical researchers and practitioners treating autistic patients.

"These children are ill, in distress and pain, and not just mentally, neurologically dysfunctional," he said. After diagnosis, Dr. Buie has successfully treated his patients by replacing suspected enzyme and probiotic deficiencies.

The results have been significant improvements in his patients’ conditions.

Left untreated these gastrointestinal problems would further complicate neurological problems and exacerbate physical problems and other symptoms of autism.

In a significant conclusion, Dr. Buie believes that many of the symptoms of autism such as self abusive behavior including self-mutilation, head-banging, unexplained outbursts, atypical sleep patterns, disrupted sleep or night awakenings, are actually symptoms of pain that a child is not able to communicate.

The Harvard research team presented their research proposal to the Northwest Autism Foundation and a select group of doctors and scientists in Portland last fall.

A summary of their proposal accompanies this presentation.

The Harvard team of researchers including Dr. Harlan Winter, Dr. Rafail Kushak and Dr. Buie are committed to providing the scientific evidence needed to establish gastrointestinal findings and develop successful methods of treatment.

This research will be used to establish a basis for the treatment of autistic children at various medical centers.

An important component of the Harvard-Mass General proposal is to establish a network of “centers of excellence” at medical universities to treat autistic children.

The centers will define and follow a standard of care.

They also envision that the centers will be linked in a consortium that will collect data and statistical correlations.

The collective database that will develop will become the basis for clinical treatment protocols for autism.

The Northwest Autism Foundation supports the Harvard – Mass General Study.

We propose that the necessary research be funded to complete this project.

The researchers are seeking less than $500,000 to continue their scientific work to completion.

The cost to the country of an untreated child with autism for education and social services is over $2 million plus the untold agony and frustration of a devastated family.

An investment of less than $500,000 to begin a solution with the Harvard-Mass General Study is an opportunity that should not be missed

Initial Autism Research Findings at Harvard - Massachusetts General Research

Experience:

* Over 400 patients evaluated

* Ages 14 Months to 20 Years

* 3:1 ratio of male:female patients

* Patients undergoing endoscopic procedure all had GI symptoms of pain or diarrhea Endoscopy Findings:

* Esophagitis in 23 out of 111 (20%)

* Gastritis in 14 out of 111 (12%); 4 had Helicobacter pylori

* Duodenitis in 11 out of 111 (10%); 2 had Celiac Sprue (According to Dr. Buie, all children with ASD should get a blood test for Celiac Sprue before going on a GF diet. Once they’re on the diet, those antibodies are

gone.)

* Eosinophilic Inflammation in 5 out of 111 (5%) Pancreatic Function

Testing: Duodenal collection of pancreatic enzymes

* 10 out of 90 (11%) had low enzyme activity (This is a very high finding among general population.)

* 2 out of these 10 (20%) had total pancreatic insufficiency, 5 with multiple enzyme defects Carbohydrate Digestion: Lactase deficiency was found in 55% of ASD children tested

* Combined deficiency of disacchraridase enzymes was found in 15%

* Enzyme assays correlate well with hydrogen breath tests Colonoscopy

Findings: Colitis was found in 11 of 89 patients (12%), none with features of Ulcerative Colitis or Crohn’s

* Histologic (biopsy reviewed) lymphoid nodular hyperplasia was found in 15 of 89 patients (16%)

* Eosinophilic inflammation was found in 13 of 89 patients (14%); cause or significance is unclear Neurotransmitters: Neurotransmitters are products which stimulate nerve activity

* A recent study showed elevation of several neurotransmitters in children with autism. These children were identified as autistic at age 15 years; the abnormal neurotransmitters were already present at birth on the heel stick blood screen.

* Every single neurotransmitter found in the brain is also found in the gastrointestinal tract.

* Mass General Hospital has begun to analyze rectal biopsy specimens for neurotransmitter abnormalities.

* Well-established normals are still being clarified.

* So far, 2 patients with profound constipation have shown a deficiency of 2 essential neurotransmitters that regulate motility.

Conclusions:

* Autistic children commonly have GI symptoms.

* All experience published so far is a laundry list of observational data.

* The brain–gut connection in autism remains to be understood.

* Evidence-based studies are necessary in order to delineate these associations.

Recommendations

* We must pay attention not only to the intestinal complaints of these children, but consider behaviors and actions as potential symptoms.

* We have to educate more than the families about GI issues; we must educate the professional community and involve them in the process of caring for these children.

Summary:

Purpose of this Proposal To learn about the gastrointestinal function of children with autism and determine if relationships exist between digestion, allergy, motility, and behavior.

Contacts

Harvard Medical School/Massachusetts General Hospital:

Timothy Buie, MD, Harland Winter, MD, Rafail Kushak, MD.

Northwest Autism Foundation:

Gleason Eakin, Lynn Hamersly, Wayne Hamersly, Joanne Hazel, Brad Parrott, David Humphrey, Mary Lynn O’Brien, MD, Gene Stubbs, MD emeritus, R. Stephen Nicholson, PhD, emeritus, Joe Taylor, Executive Director

Northwest Autism Foundation (Phone) 503-557-2111 o Fax (503) 557-2156

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* * *

Karyn Seroussi's List of Autism-Bio Studies

I've spent four solid days compiling a large list of references for studies regarding dietary and biological interventions for autism. I was surprised by how many supportive studies have actually been done and published. Most of the medical and scientific abstracts are from major peer-reviewed journals. This list should be a great resource for parents who are enlisting the support of their physicians. It will also be extremely helpful as a reference and resource for supportive physicians who are trying to get an overview of the science done to date.

This includes everything I was able to find that seemed relevant or useful, and I excluded only a few that seemed redundant. Despite the time I put into it, I'm sure I missed some. If you know of additional studies that you would like to see included, please send them to me at kseroussi@aol.com.

Karyn Seroussi

ANDI (Autism Network for Dietary Intervention)

[Here is a sample of what's at the website.]

Journal articles regarding autism, food allergy, gastrointestinal abnormalities, gluten, dairy, and the effects of the opiate properties of milk and wheat-derived peptides on neurological function .

Summary: Based on reports from caregivers, case studies and observation of patients with schizophrenia and children with severe behavioral disorders, Dr. FC Dohan hypothesized in 1960s and 70s that gluten and dairy seemed to worsen these behaviors, and that in many cases, a restricted diet could lead to significant improvement or recovery from these disorders.

The biochemical explanation for this phenomenon remained unclear, however, several other studies seemed to bear out this observation, and in 1981, using more advanced laboratory technology, Dr. Karl Reichelt, Director of Clinical Chemistry for the Department of Pediatric Research at the Rikshospitalet (National Hospital) in Oslo, Norway, found and reported abnormal peptides in the urine of schizophrenics and autistics.

Peptides are pieces of proteins that are not completely broken down into individual amino acids.

Dr. Reichelt has observed that these peptides, which are 4 or 5 or 6 amino acids long, have sequences that match those of opioid peptides (casomorphin and gliadomorphin).

The known dietary sources of these opiate peptides are casein (from

milk) and gliadin or gluten (from cereal grains).

He has since conducted several studies examining this finding, as have several other researchers, including Paul Shattock at the University of Sunderland in England, Dr. Robert Cade at the University of Florida, Gainesville, and Dr. Alan Friedman, of Johnson and Johnson Ortho Clinical Diagnostics.

The best evidence for this correlation lies in the thousands of case reports of improvement or recovery of children with autism on this diet.

However, responsible physicians who have taken the time to review these studies must agree that there is, indeed, significant scientific evidence to support a trial period of careful elimination of these proteins from the diet of children on the autistic spectrum.

Some Abstract Titles

Biochemical aspects in autism spectrum disorders: updating the opioid-excess theory and presenting new opportunities for biomedical intervention. Whiteley P, Shattock P: Expert Opin Ther Targets. 2002 Apr;6(2):175-83.

A randomised, controlled study of dietary intervention in autistic syndromes Knivsberg AM, Reichelt KL, Hoien T, Nodland M: . Nutr Neurosci 2002 Sep;5(4):251-61.

Diet in autism and associated disorders. Garvey J: J Fam Health Care 2002;12(2):34-8.

Gluten and casein free diets in autism: a study of the effects on food choice and nutrition.Cornish E: J Hum Nutr Diet 2002 Aug;15(4):261-9.

Reports on dietary intervention in autistic disorders. Knivsberg AM, Reichelt KL, Nodland M: Nutr Neurosci 2001;4(1):25-37.

Changes in beta-casomorphine-7 effect on behavior of albino rat pups in postnatal development [Article in Russian].Dubynin VA , Ivleva IuA, Malinovskaia IV, Kamenskii AA, Andreeva LA, Alfeeva LIu, Miasoedov NF Zh Vyssh Nerv Deiat Im I P Pavlova 2001 May-Jun;51(3):386-9.

Milk-induced reflux in infants less than one year of age. Cavataio F, Carroccio A, Iacono G.: J Pediatr Gastroenterol Nutr 2000;30 Suppl:S36-44

Evidence of very delayed clinical reactions to cow's milk in cow's milk-intolerant patients. Carroccio A, Montalto G, Custro N, Notarbartolo A, Cavataio F, D'Amico D, Alabrese D, Iacono G: Allergy 2000 Jun;55(6):574-9.

Autism and schizophrenia: intestinal disorders. Cade R, Privette M, Fregly M, Rowland N, Sun Z, Zele V, Wagemaker H, Edlestein C:Nutritional Neuroscience 3: 57-72, 2000. [No abstract available]

Serotonin uptake stimulating peptide found in plasma of normal individuals and in some autistic urines. J Pept Res 1999 Jun;53(6):641-6 Pedersen OS, Liu Y, Reichelt KL. Ek J, Stensrud M, Reichelt KL.

Gluten-free diet decreases urinary peptide levels in children with celiac disease. J Pediatr Gastroenterol Nutr 1999 Sep;29(3):282-5.

* * *

Help for Autism – Another Research Summary

AN-100005

AUTISM: According to the National Institute of Neurological Disorders and Stroke, autism is a developmental disorder of brain function. There are typically three classic symptoms: impaired social interaction, difficulty with verbal and nonverbal communication and severely limited activities and interests. The symptoms generally appear in the first three years of the child's life and may last through their lifetime. There is currently no cure for this disorder.

DENVER MODEL BELIEFS: This technique was developed over many years, by a group of therapists and researchers. These are the main beliefs of the

approach:

* Families should be at the helm of their children's treatment.

* Because each child with autism and his or her family is unique;

goals, interventions, and approaches must be individualized.

* Children with autism can be successful learners. Lack of progress

generally signals problems with the design and implementation of the educational activity, rather than the inability of the child to learn.

* Because autism is, at its core, a social disorder, treatment for

autism must focus on social disability. This requires that relationships be at the core of treatment of children with autism and their families.

* Children are members of families and communities and need to have

a role in family life and family and community activities.

* Children with autism have minds, opinions, preferences, choices,

and feelings; they have a right to self-expression and some control of their world.

* Autism is a complex disorder affecting virtually all areas of

functioning; interdisciplinary professional guidance is needed to address the wide range of challenges that autism presents.

* Children with autism are capable of becoming intentional, symbolic

communicators, and the majority of children with autism can develop useful, communicative speech when provided with appropriate interventions of sufficient intensity during the preschool years.

* Various intervention approaches for children with autism have

demonstrated their effectiveness using various instructional methodologies; a comprehensive, contemporary treatment approach must be able to draw from all expertise available in the field.

* Play is one of the young child's most powerful cognitive and

social learning tools. Building play skills in young children with autism will maximize their capacity for independent learning.

Successful intervention for young children with autism requires that most of their waking hours be spent in socially oriented activities. Providing more than 20 hours per week of structured intervention is necessary for optimum progress.

If you would like more information, please contact: Sarah Ellis

Director, News Media Relations University of Colorado Health Sciences

Center and University of Colorado Hospital 4200 East Ninth Avenue, #A092

Denver, CO 80262 (303)-315-7470

* * *

Mercury Dental Fillings Said Safe

The government still considers mercury-containing dental fillings safe and is awaiting results from two major studies of children's cavities that may settle lingering public doubts.

Amalgam fillings, sometimes called silver fillings, are made of a mixture of mercury and other metals, and have been used by dentists for over 100 years.

Critics argue that mercury may leach from those fillings and cause brain disorders such as autism. Some families of autistic children have sued dentists, and legislation introduced in Congress last spring seeks to ban the fillings by 2007.

Repeated reviews from federal health officials have found no proof the fillings are dangerous, officials from the Food and Drug Administration and National Institutes of Health told a congressional committee Thursday.

More evidence may come in 2006, when two major studies comparing the health of more than 1,000 children given either amalgam fillings or a mercury-free kind are to end, said NIH dental chief Lawrence Tabak.

The studies, funded by NIH in 1996, are measuring levels of mercury in the children's bodies, and giving them IQ tests and other brain assessments.

Special oversight boards review the children's medical records every year, and "to date there have been no harmful untoward effects attributable to amalgam noted in either trial," Tabak told the House Government Reform Committee.

Mercury is a toxic metal that can be absorbed from different sources, such by eating fish from polluted waters. Indeed, the FDA warns pregnant women and young children to avoid certain fish species that contain high mercury levels.

Why, wondered the committee chairman, Rep. Dan Burton, R-Ind., is the FDA is worried about one type of mercury and not another.

"Mercury is mercury," said Burton, a comment echoed by other mercury critics at the hearing. "Shouldn't we exercise abundance of caution and hasten the use of those (mercury-free) alternatives?"

The American Dental Association argued that the mercury in fillings is a different form of the metal that is safe to use, and that amalgam fillings are both cheaper than other types and the best option for certain cavities.

* * *

Academia Fails To Protect Research From Industry Bias

Drug company dollars taint much of medical research, study reports.

Medical colleges routinely ignore guidelines created to maintain the integrity of clinical research when collaborating with the pharmaceutical industry, according to a study published in the Oct. 24 New England Journal of Medicine.

The study revealed that schools rarely followed guidelines from the International Committee of Medical Journal Editors to ensure that their investigators had full participation in the design of trials, free access to trial data and the right to publish their findings, including editorial control.

Other safeguards, such as having an independent executive committee, data and safety monitoring board, or publications committee, were also not incorporated into research agreements between universities and commercial firms. Without taking such steps, medical schools are failing to protect the validity of their research and are risking losing the trust of the public, the study concluded.

In a related article in the same issue, it was noted that recent reviews of research guidelines focused only on clinical research, though nonclinical research is attracting significant commercial sponsorship and merits the same attention to conflicts of interest.

"Basic research in normal biology and disease mechanisms is growing increasingly dependent on sophisticated techniques and complex equipment with high initial costs and high maintenance costs," the authors stated, making it all the more difficult for academic institutions to find sufficient funding outside of the pharmaceutical industry.

Whether clinical or nonclinical work is being done, the growing scale of collaboration between the pharmaceutical industry and medical schools has prompted intense scrutiny of conflict of interest issues.

But research guidelines that have been released to date should be considered just starting points, the authors said, with basic science research and nonclinical studies needing better oversight to keep commercial bias from influencing results or limiting access to information.

* * *

Are Environmental Agents Behind The Autism Epidemic?

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A recent study from the University of California at Davis has validated reports of an unprecedented and baffling nationwide epidemic of autism, at the same time it challenges current scientific thinking about how diseases are caused.

Once blamed on emotionally distant mothers, more recent theories of autism invoke mainly genetic causation. But if we are facing an epidemic, the new research implicates environmental agents.

Autism, once thought to be rare, is as heartbreaking as it is now widespread. Parents often describe normally developing infants who inexplicably begin to deteriorate in the second year of life. Language is impaired; many cannot even speak. Social interaction is limited. The children make little or no eye contact and do not engage with playmates. Severe behavior issues arise. Cognitive abilities may decline. Seizures, clumsiness, gastrointestinal problems, immune imbalances, metabolic abnormalities and other conditions are often present. These children require increased medical care, specialized education and constant - usually lifelong - supervision. Families are stressed, schools can't cope and doctors have very little to offer.

The M.I.N.D. Institute at UC-Davis reviewed data from the California Department of Developmental Services, which showed nearly a statewide tripling of the most severe autism in little more than a decade, from 1987 to 1998. It ruled out other possible causes for the reported increases, such as better diagnosis or immigration into the state.

Beyond California, figures from the U.S. Department of Education show a nationwide average increase of 544 percent in autistic students from 1992-93 to 2000-01. Studies in Atlanta and New Jersey, by the Centers for Disease Control, turned up autism among 1 in 250 to 300 children. And these numbers reflect only the most severe cases: Including milder forms raised the rate in New Jersey to 1 in 150 children. Prior to 1980, studies showed autism rates of 1 in 2,000.

It is time to rethink the emphasis on genetics in autism research. As M.I.N.D. Institute study leader Dr. Robert Byrd said, "Genes don't cause epidemics." Autism research dollars have flowed to support genetic studies designed to find aberrant genes, but the only effective treatments have been expensive behavior-based interventions.

The new study strongly suggests that something else must be involved, because the human genome simply doesn't change this fast. So we must look where such rapid change does occur - in the environment.

If we are having an epidemic, then environmental influences, which could include chemicals, metals, vaccines and viruses, must be overwhelming more children than ever before. Since genes that affect the brain also affect the body, environmental triggers of autism would affect both. And in fact this "behavioral" disorder is often accompanied by gastrointestinal or immune diseases or other illness.

The cost of autism lies not only in human suffering. In California alone, nine new children are diagnosed with autism every day. Conservative estimates of $2 million for each autistic child's lifetime care do not include lost wages of the child or family members. Meanwhile, the National Institutes of Health spends $56 million per year on autism research - much better than the $5 million budgeted just five years ago but not sufficient for such an epidemic.

We must focus attention - and research dollars - on our environment and not just our genes. If we do not, we face more rising epidemics of unexplained diseases.

Martha R. Herbert is a pediatric neurologist at Massachusetts General Hospital and Harvard Medical School, and a board member of the Council for Responsible Genetics. This article was distributed by the National Environmental Trust, an op-ed service in Washington.

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COMMENTARY

Homeland Hijinks And White House Whitewash: The Bush Administration Is Not Only Protecting The Vaccine Manufacturers But Also The FDA By Sneaking In Fine Print Into The Homeland Bill

As you know by now, the Homeland Bill contains several peculiar wrinkles that have little to do with security. As is typical in the U.S., politically-contrived weird stuff gets attached to bills, often as a result of the slime politics that go on in backrooms. In this particular instance, it is the White House that wanted ridiculous breaks for drug companies thrown into the 484-page Homeland Bill.

So, for example, if you are, say, Eli Lilly, this is a happy time because the Bill, if passed, would allow you special protection against any lawsuits claiming that Thimerosal, the mercury preservative for vaccines that you have been peddling for years, causes neurodevelopment problems, including autism.

Now why would the White House want to protect the drug industry (aside from the fact that it contributes heavily to Republican coffers)? The official reason making the rounds this week is that liability protection would give the vaccine industry that extra bit of confidence to go ahead and make the necessary vaccines against the "bioterrorism threat."

No more worries about all those pending lawsuits claiming that Thimerosal caused damage to children.

If the White House wants us to believe this crock, then it should be very pleased to provide detailed evidence of the profit trends of companies which continue to make vaccines. Why hold back, show us that these very impoverished companies are on death’s row and that they will be incapable of producing vaccine for the masses in case of a biowar. Let’s see the data.

The fact is, the vaccine industry is truly in a mess, but not for the reasons the White House would have us believe. The industry does not do relevant research on vaccines and continues, with help from its CDC, FDA and doctor friends, to heap one vaccine after another on children without doing anything close to what might be considered appropriate safety and efficacy research. And this has been going on for decades.

The Thimerosal issue made this all so simple to see: a preservative put into vaccines that the FDA did absolutely nothing about until December 14, 1998, when it first asked manufacturers of vaccines to provide detailed information about the ingredients they used in their products.

That came on the heels of the FDA Modernization Act of 1997 which prompted the agency to try to establish the levels of risk for all food and drugs containing mercury. By then it was a non-brainer that mercury could be highly toxic. But when you get right down to it, the FDA intervention was a long time coming because Thimerosal had been in use since the early 1930s.

Almost 50 per cent organic mercury by weight, it was never necessary to maker a vaccine either safe or effective. It offers protection against the possibility of a vaccine becoming contaminated when a health professional introduces one needle after another into a multi-dose vial as shots are needed.

FDA documents indicate that the concerns about Thimerosal rose sharply once the data from the vaccine manufacturers began to be analyzed in 1999. In fact, referring to the concerns as at least "mild panic" would not be inappropriate. It quickly became evident that many millions of children in North America and elsewhere might have been receiving overdoses of mercury from vaccines and that many might have been poisoned.

Especially at issue were three vaccines from among those on the recommended schedule for children under six months of age. Three doses of DTaP (the newest type of vaccine for diphtheria-tetanus-pertussis) amounted to 75 micrograms of mercury. The same was true for three doses of the Haemophilus influenzae type b vaccine, given to protect against a range of bacterial infections, including meningitis. And three doses of the hepatitis B vaccine yielded 37.5 micrograms. The total of 187.5 micrograms of mercury over six months greatly exceeded the safe limit set by the Environmental Protection Agency (EPA) of 0.1 micrograms per kilo of body weight per day. For example, for a child following the standard vaccination schedule, shots at two months of age would yield 62.5 micrograms of mercury. Depending on the child’s body weight, that could result in more than 30 times the EPA’s recommended daily maximum exposure.

Unfortunately, the FDA, which was, at long last, trying to whip itself into some shape on Thimerosal, wasn’t really clear on the concept. What did those data really mean? For one thing, the EPA’s safe limit was, at best, a crude estimate, based on very little research. Also, that estimate was for methyl mercury and it was actually ethyl mercury that is the active ingredient in Thimerosal. The conundrum was that there was relatively little scientific data available on the toxicity of lower doses of this particular compound, even though it is a chemical cousin to methyl mercury. So, given the lack of data and appropriate federal guidelines upon which to base a proper risk assessment, the FDA decided to assume that both forms of mercury were similar. Not exactly what one might call science, but the agency had been caught with its pants down. All that mercury being injected into infants, and in large quantities too, and there was little, if any, understanding of the health effects.

On what basis, then, was Thimerosal ever considered safe for use in vaccines? To dig up the answer, you have to go back to the late 1920s. Documents from Eli Lilly show that the pharmaceutical giant had sponsored a human toxicity study with Thimerosal, but the choice was odd because the product was used on patients already dying from meningitis. In other words, how could the company possibly determine whether the product was toxic or harmful if people were as good as dead when the study began? That type of preliminary study, to make any sense, should have been conducted on healthy volunteers. But the company claimed that Thimerosal was not harmful to humans. And since there was no stampede to determine whether there was competent science behind the study, it became an urban legend of sorts.

To date, there have been no published studies whatsoever, that have specifically examined the exposure of infants to ethyl mercury and its health effects.

And now the White House wants to whitewash this offensive history and give the drug industry as well as the FDA a wink as business continues as usual.

* * *

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