[Congressional Record (Bound Edition), Volume 149 (2003), Part 9]
[Extensions of Remarks]
[Pages 12720-12739]
[From the U.S. Government Publishing Office, www.gpo.gov]




                       MERCURY IN MEDICINE REPORT

                                 ______
                                 

                            HON. DAN BURTON

                               of indiana

                    in the house of representatives

                         Tuesday, May 20, 2003

  Mr. BURTON of Indiana. Mr. Speaker, I submit the following report 
prepared by the staff of the Subcommittee on Human Rights and Wellness, 
Committee on Government Reform. This report is the result of a three-
year investigation initiated in the Committee on Government Reform.

             Mercury in Medicine--Taking Unnecessary Risks


                          I. Executive Summary

       Vaccines are the only medicines that American citizens are 
     mandated to receive as a condition for school and day care 
     attendance, and in some instances, employment. Additionally, 
     families who receive federal assistance are also required to 
     show proof that their children have been fully immunized. 
     While the mandate for which vaccines must be administered is 
     a state mandate, it is the Federal Government, through the 
     Centers for Disease Control and Prevention (CDC) and its 
     Advisory Committee for Immunization Practices that make the 
     Universal Immunization Recommendations to which the majority 
     of states defer when determining mandates. Since the early to 
     mid-1990s, Congress has been concerned about the danger posed 
     by mercury in medical applications, and in 1997, directed the 
     Food and Drug Administration (FDA) to evaluate the human 
     exposure to mercury through foods and drugs.
       In 1999, following up on the FDA evaluation and pursuant to 
     its authority, the House Committee on Government Reform 
     initiated an investigation into the dangers of exposure to 
     mercury through vaccination. The investigation later expanded 
     to examine the potential danger posed through exposure to 
     mercury in dental amalgams. This full committee investigation 
     complemented and built upon the investigations initiated by 
     two of its subcommittees. In January 2003, the investigation 
     continued in the newly formed Subcommittee on Human Rights 
     and Wellness.
       A primary concern that arose early in the investigation of 
     vaccine safety was the exposure of infants and young children 
     to mercury, a known toxin, through mandatory childhood 
     immunizations. This concern had been raised as a possible 
     underlying factor in the dramatic rise in rates of late-onset 
     or ``acquired'' autism. The symptoms of autism are markedly 
     similar to those of mercury poisoning.
       Significant concern has been raised about the continued use 
     of mercury in medical applications decades after the 
     recognition that mercury can be harmful, especially to our 
     most vulnerable population--our children. This report will 
     address one form of mercury in medical applications, 
     Thimerosal, as a preservative in vaccines.
       In July 2000, it was estimated that 8,000 children a day 
     were being exposed to mercury in excess of Federal guidelines 
     through their mandatory vaccines.
       One leading researcher made the following statement to the 
     Committee in July 2000:
       ``There's no question that mercury does not belong in 
     vaccines.
       ``There are other compounds that could be used as 
     preservatives. And everything we know about childhood 
     susceptibility, neurotoxicity of mercury at the fetus and at 
     the infant level, points out that we should not have these 
     fetuses and infants exposed to mercury. There's no need of it 
     in the vaccines.''
       The Food and Drug Administration's (FDA) mission is to 
     ``promote and protect the public health by helping safe and 
     effective products reach the market in a timely way, and 
     monitoring products for continued safety after they are in 
     use.'' However, the FDA uses a subjective barometer in 
     determining when a product that has known risks can remain on 
     the market. According to the agency, ``at the heart of all 
     FDA's product evaluation decisions is a judgment about 
     whether a new product's benefits to users will outweigh its 
     risks. No regulated product is totally risk-free, so these 
     judgments are important. FDA will allow a product to present 
     more of a risk when its potential benefit is great--
     especially for products used to treat serious, life-
     threatening conditions.''
       This argument--that the known risks of infectious diseases 
     outweigh a potential risk of neurological damage from 
     exposure to thimerosal in vaccines, is one that has 
     continuously been presented to the Committee by government 
     officials. FDA officials have stressed that any possible risk 
     from thimerosal was theoretical: that no proof of harm 
     existed. Upon a thorough review of the scientific literature 
     and internal documents from government and industry, the 
     Committee did in fact find evidence that thimerosal posed a 
     risk. The possible risk for harm from either low dose chronic 
     or one time high level (bolus dose) exposure to thimerosal is 
     not ``theoretical,'' but very real and documented in the 
     medical literature.
       Congress has long been concerned about the human exposure 
     to mercury through medical applications. As a result of these 
     concerns, in 1997, Congress instructed the FDA to evaluate 
     the human exposure to mercury through drugs and foods. 
     Through this Congressionally mandated evaluation, the FDA 
     realized that the amount of ethylmercury infants were exposed 
     to in the first six months of life through their mandatory 
     vaccinations exceeded the Environmental Protection Agency's 
     (EPA) limit 
     for a closely associated compound methylmercury. The FDA and 
     other Federal

[[Page 12721]]

     agencies determined that in the absence of a specific 
     standard for ethylmercury, the limits for ingested 
     methylmercury should be used for injected ethylmercury. The 
     Institute of Medicine, in 2000, evaluated the EPA's 
     methylmercury standard and determined that based upon 
     scientific data that it, rather than the FDA's, was the 
     scientifically validated safe exposure standard.
       Rather than acting aggressively to remove thimerosal from 
     children's vaccines, the FDA and other agencies within the 
     Department of Health and Human Services (HHS) adopted an 
     incremental approach that allowed children to continue to be 
     exposed to ethylmercury from vaccines for more than two 
     additional years. In fact, in 2001, the Centers for Disease 
     Control and Prevention (CDC) refused even to express a 
     preference for thimerosal-free vaccines, despite the fact 
     that thimerosal had been removed from almost every childhood 
     vaccine produced for use in the United States.
       On three occasions in the last 15 years, changes have been 
     made to vaccine policies to reduce the risk of serious 
     adverse effects. First, a transition from oral polio vaccine 
     to injected polio was accomplished in the United States to 
     reduce the transmission of vaccine-induced polio. Second, an 
     acellular pertussis vaccine was developed and a transition 
     from DTP to DTaP was accomplished to reduce the risk of 
     pertussis--induced seizures in children. And third, when the 
     Rotashield vaccine for rotavirus was linked to a serious 
     bowel condition (intersucception), it was removed from the 
     U.S. market. Ethylmercury has been largely removed from every 
     major childhood vaccine manufactured for use in the United 
     States, except the influenza vaccine, which continues to 
     contain trace amounts.
       This success, however, does not change the fact that 
     millions of American children were exposed to levels of 
     mercury through vaccines that exceeded comparable federal 
     guidelines. Many parents, and a growing number of scientists, 
     believe that this mercury exposure may have contributed to 
     the explosive growth in autism spectrum disorders, and 
     neurological and behavioral disorders that this country has 
     experienced. The scientific evidence in this area is 
     considered by some to still be inconclusive, in large part 
     due to the lack of serious, effective inquiry by our health 
     agencies. The federal government has an obligation to 
     vigorously pursue the necessary research to determine the 
     extent of the impact of these heightened exposures to 
     ethylmercury on our population.
       A second concern that arose during the investigation was 
     the continued use of mercury in dental amalgams. Mercury has 
     been used as a component in dental fillings since the Civil 
     War era. The American Dental Association and its member 
     dentists have taken a position that the mercury in fillings, 
     which are considered toxic until placed in the tooth, and is 
     considered toxic when removed from the mouth, is completely 
     safe while in the human mouth. This position seems counter 
     even to the ADA-funded research that shows the daily release 
     of small amounts of mercury vapors in the human mouth where 
     dental amalgams are present, as well as minute chipping and 
     swallowing of the mercury fillings over time.
       Babies and young children are exposed to this additional 
     mercury. As developing fetuses, babies are exposed to mercury 
     through the placenta. If pregnant women have mercury 
     amalgams, they are unknowingly excreting low levels of 
     mercury on a daily basis to their fetuses. Additionally, 
     children who receive dental services through Medicaid are 
     also potentially exposed to mercury. When these children need 
     dental fillings, because of the low cost, only mercury 
     amalgams are available for use. This concern remains under 
     investigation by the Subcommittee on Human Rights and 
     Wellness.


                    II. Findings and Recommendations

                              A. Findings

       Through this investigation of pediatric vaccine safety, the 
     following findings are made:
       1. Mercury is hazardous to humans. Its use in medicinal 
     products is undesirable, unnecessary and should be minimized 
     or eliminated entirely.
       2. For decades, ethylmercury was used extensively in 
     medical products ranging from vaccines to topical ointments 
     as preservative and an anti-bacteriological agent.
       3. Manufacturers of vaccines and thimerosal, (an 
     ethylmercury compound used in vaccines), have never conducted 
     adequate testing on the safety of thimerosal. The FDA has 
     never required manufacturers to conduct adequate safety 
     testing on thimerosal and ethylmercury compounds.
       4. Studies and papers documenting the hyperallergenicity 
     and toxicity of thimerosal (ethylmercury) have existed for 
     decades.
       5. Autism in the United States has grown at epidemic 
     proportions during the last decade. By some estimates the 
     number of autistic children in the United States is growing 
     between 10 and 17 percent per year. The medical community has 
     been unable to determine the underlying cause(s) of this 
     explosive growth.
       6. At the same time that the incidence of autism was 
     growing, the number of childhood vaccines containing 
     thimerosal was growing, increasing the amount of ethylmercury 
     to which infants were exposed threefold.
       7. A growing number of scientists and researchers believe 
     that a relationship between the increase in 
     neurodevelopmental disorders of autism, attention deficit 
     hyperactive disorder, and speech or language delay, and the 
     increased use of thimerosal in vaccines is plausible and 
     deserves more scrutiny. In 2001, the Institute of Medicine 
     determined that such a relationship is biologically 
     plausible, but that not enough evidence exists to support or 
     reject this hypothesis.
       8. The FDA acted too slowly to remove ethylmercury from 
     over-the-counter products like topical ointments and skin 
     creams. Although an advisory committee determined that 
     ethylmercury was unsafe in these products in 1980, a rule 
     requiring its removal was not finalized until 1998.
       9. The FDA and the CDC failed in their duty to be vigilant 
     as new vaccines containing thimerosal were approved and added 
     to the immunization schedule. When the Hepatitis B and 
     Haemophilus Influenzae Type b vaccines were added to the 
     recommended schedule of childhood immunizations, the 
     cumulative amount of ethylmercury to which children were 
     exposed nearly tripled.
       10. The amount of ethylmercury to which children were 
     exposed through vaccines prior to the 1999 announcement 
     exceeded two safety thresholds established by the Federal 
     government for a closely related substance--methylmercury. 
     While the Federal Government has established no safety 
     threshold for ethylmercury, experts agree that the 
     methylmercury guidelines are a good substitute. Federal 
     health officials have conceded that the amount of thimerosal 
     in vaccines exceeded the EPA threshold of 0.1 micrograms per 
     kilogram of bodyweight. In fact, the amount of mercury in one 
     dose of DTaP or Hepatitis B vaccines (25 micrograms each) 
     exceeded this threshold many times over. Federal health 
     officials have not conceded that this amount of thimerosal in 
     vaccines exceeded the FDA's more relaxed threshold of 0.4 
     micrograms per kilogram of body weight. In most cases, 
     however, it clearly did.
       11. The actions taken by the HHS to remove thimerosal from 
     vaccines in 1999 were not sufficiently aggressive. As a 
     result, thimerosal remained in some vaccines for an 
     additional two years.
       12. The CDC's failure to state a preference for thimerosal-
     free vaccines in 2000 and again in 2001 was an abdication of 
     their responsibility. As a result, many children received 
     vaccines containing thimerosal when thimerosal-free 
     alternatives were available.
       13. The Influenza vaccine appears to be the sole remaining 
     vaccine given to children in the United States on a regular 
     basis that contains thimerosal. Two formulations recommended 
     for children six months of age or older continue to contain 
     trace amounts of thimerosal. Thimerosal should be removed 
     from these vaccines. No amount of mercury is appropriate in 
     any childhood vaccine.
       14. The CDC in general and the National Immunization 
     Program in particular are conflicted in their duties to 
     monitor the safety of vaccines, while also charged with the 
     responsibility of purchasing vaccines for resale as well as 
     promoting increased immunization rates.
       15. There is inadequate research regarding ethylmercury 
     neurotoxicity and nephro-
     toxicity.
       16. There is inadequate research regarding the relationship 
     between autism and the use of mercury-containing vaccines.
       17. To date, studies conducted or funded by the CDC that 
     purportedly dispute any correlation between autism and 
     vaccine injury have been of poor design, under-powered, and 
     fatally flawed. The CDC's rush to support and promote such 
     research is reflective of a philosophical conflict in looking 
     fairly at emerging theories and clinical data related to 
     adverse reactions from vaccinations.

                           B. Recommendations

       1. Access by independent researchers to the Vaccine Safety 
     Datalink database is needed for independent replication and 
     validation of CDC studies regarding exposure of infants to 
     mercury-containing vaccines and autism. The current process 
     to allow access remains inadequate.
       2. A more integrated approach to mercury research is 
     needed. There are different routes that mercury takes into 
     the body, and there are different rates of absorption. 
     Mercury bioaccumulates; the Agency for Toxic Substances and 
     Disease Registry (ATSDR) clearly states: ``This substance may 
     harm you.'' Studies should be conducted that pool the results 
     of independent research that has been done thus far, and a 
     comprehensive approach should be developed to rid humans, 
     animals, and the environment of this dangerous toxin.
       3. Greater collaboration and cooperation between federal 
     agencies responsible for safeguarding public health in regard 
     to heavy metals is needed.
       4. The President should announce a White House conference 
     on autism to assemble the best scientific minds from across 
     the country and mobilize a national effort to uncover the 
     causes of the autism epidemic.

[[Page 12722]]


       5. Congress needs to pass legislation to include in the 
     National Vaccine Injury Compensation Program (NVICP) 
     provisions to allow families who believe that their 
     children's autism is vaccine-induced the opportunity to be 
     included in the program. Two provisions are key: First, 
     extending the statute of limitations as recommended by the 
     Advisory Commission on Childhood Vaccines from 3 to 6 years. 
     Second, establishing a one to two-year window for families, 
     whose children were injured after 1988 but who do not fit 
     within the statute of limitations, to have the opportunity to 
     file under the NVICP.
       6. Congress should enact legislation that prohibits federal 
     funds from being used to provide products or pharmaceuticals 
     that contain mercury, methylmercury, or ethylmercury unless 
     no reasonable alternative is available.
       7. Congress should direct the National Institutes of Health 
     to give priority to research projects studying causal 
     relation-
     ships between exposure to mercury, methylmercury, and 
     ethylmercury to autism spectrum disorders, attention deficit 
     disorders, Gulf War Syndrome, and Alzheimer's Disease.


 III. Thimerosal Has Been Used In Vaccines And Other Medical Products 
                              For Decades

                   A. A brief description of mercury

       Mercury is a silver-colored metal, which unlike any other 
     metal, is a liquid at room temperature. It flows so easily 
     and rapidly that it is sometimes called quicksilver. The 
     chemical symbol for Mercury is Hg.
       Mercury has many properties that have made it popular for a 
     number of commercial uses. For example, mercury expands and 
     contracts evenly when heated or cooled. It also remains 
     liquid over a wide range of temperatures and does not stick 
     to glass. These properties have prompted its use in 
     thermometers. Mercury conducts electricity and is used in 
     some electric switches and relays to make them operate 
     silently and efficiently. Industrial chemical manufacturers 
     use mercury in electrolysis cells to charge substances with 
     electricity. Mercury vapor, used in fluorescent lamps, gives 
     off light when electricity passes through it. Before its 
     health effects were well understood, mercury compounds were 
     widely used in such common products as house paints and 
     paper.
       Various alloys (mixtures of metals) containing mercury have 
     many uses. Mercury alloys are called amalgams. These would 
     include silver amalgam, a mixture of silver and mercury that 
     dentists use to fill cavities in teeth.
       Mercury comes in many different forms--organic, inorganic, 
     elemental, and metallic. As a result of its many practical 
     uses, mercury became widespread in the environment. However, 
     it is now widely recognized that overexposure to all forms of 
     mercury can harm the central nervous system (brain) and the 
     renal system (kidneys). This has led to regulatory actions to 
     reduce the exposure of humans to mercury on many fronts. 
     According to the Agency for Toxic Substances and Disease 
     Registry (ATSDR): ``The nervous system is very sensitive to 
     all forms of mercury.''

B. Thimerosal, which contains ethylmercury, has been used in medicines 
                            since the 1930's

       In addition to its many commercial applications, mercury 
     has been used in a number of medical applications. One such 
     product that came into frequent use during the twentieth 
     century was thimerosal. Thimerosal is an organic compound 
     made up of equal parts of thiosalicylic acid and 
     ethylmercury. It is 49.6 percent ethylmercury by weight.
       Thimerosal was developed by Dr. Morris Kharasch (1895-1957; 
     Ukraine/USA), a chemist and Eli Lilly fellow first at the 
     University of Maryland (1922-1927) and then at the University 
     of Chicago. He filed for a patent on June 27, 1929, for what 
     he described as an alkyl mercuric sulfur compound 
     (thimerosal), which he felt had potential as an antiseptic 
     and antibacterial product. Dr. Kharasch was considered a 
     pioneer in his field, contributing to the development of 
     plastics and the creation of synthetic rubber. He also went 
     on to found the Journal of Organic Chemistry.
       In October 1929, Eli Lilly and Company registered 
     thimerosal under the trade name Merthiolate. Merthiolate was 
     used to kill bacteria and prevent contamination in antiseptic 
     ointments, creams, jellies, and sprays used by consumers and 
     in hospitals. Thimerosal was also used in nasal sprays, eye 
     drops, contact lens solutions, immunoglobulins, and most 
     importantly here--vaccines.
       Thimerosal was patented the same year that Alexander 
     Fleming discovered penicillin. But because it took more than 
     a decade for penicillin to be fully developed, and large-
     scale production to begin, thimerosal was widely used in the 
     interim. To the medical profession, who were without 
     antibiotics during the 1930's and 1940's, thimerosal 
     (marketed as Merthiolate) and other antiseptic products were 
     gladly received.
       Dr. H. Vasken Aposhian, Professor of Molecular and Cellular 
     Biology and Pharmacology, University of Arizona discussed 
     thimerosal's history during Congressional testimony:
       ``In the early thirties, in fact the 1940's and up until 
     the mid-1950's, mercurials were used in medicine . . . . The 
     medical community . . . had nothing better to use. They had 
     nothing better to use as a preservative at that time than 
     thimerosal. And I would venture the opinion that it has just 
     been going on because no one has objected to it. And there's 
     no need for it any longer. And I don't know any medical 
     community or scientific community that would agree to the 
     need for having thimerosal in any vaccine.''
       Thimerosal became the most widely used preservative in 
     vaccines and other medical products. Its use in antiseptic 
     products to prevent infections was common. By the time that 
     the FDA conducted its review of mercury in 1999, more than 50 
     licensed vaccines contained thimerosal.
       While thimerosal became widely used, there were repeated 
     references in the scientific literature to the lack of 
     substantial understanding of its safety. In numerous 
     publications, researchers suggested that caution be taken in 
     human exposure. For example, a paper published in 1934 noted, 
     ``little is known about the mercuric compounds when 
     inoculated into humans. It is therefore preferable to use the 
     minimum amount of this preservative.''
       Eli Lilly ceased its production of vaccines in 1974. 
     Shortly after the FDA advisory committee determined that 
     thimerosal in over-the-counter products was no longer 
     ``generally recognized as safe,'' Eli Lilly and other 
     companies chose to cease production of products such as 
     merthiolate and mercurichrome. By the mid-1980's, Eli Lilly 
     was completely out of the business of manufacturing or 
     selling thimerosal-containing products. However, thimerosal 
     continued to be used in vaccines. In the 1990's, thimerosal 
     was manufactured by numerous companies, including Sigma-
     Aldrich, Inc.; EM Industries, Inc. (now EMD Chemicals Inc., 
     the North American extension of Merck KGaA); Dow Chemical 
     Company; Spectrum Laboratory Products, Inc. (formerly 
     Spectrum Quality Products, Inc.); and GDL International, Inc.

   C. Mercury is a known neurotoxin, but methylmercury has been more 
                  carefully studied than ethylmercury

       After more than a century of research, it has become widely 
     accepted in the scientific and medical communities that 
     mercury is a neurotoxin. While debate continues over what 
     levels of exposure to mercury are safe, it is unquestioned 
     today that overexposure to mercury in any form can cause 
     neurological and renal damage. There is also a growing 
     consensus around the theory that some individuals are more 
     susceptible to harm from mercury than others, confounding 
     efforts to adopt a population-level threshold for safe levels 
     of mercury in the environment. A research paper published in 
     2002 summarized the scientific consensus very succinctly: 
     ``Mercury and its compounds are cumulative toxins and in 
     small quantities are hazardous to human health.''
       Because of its many commercial applications and its 
     widespread presence in the environment, methylmercury 
     received the lion's share of the attention in the scientific 
     community during the twentieth century. A concise history of 
     the early development of scientific knowledge about 
     methylmercury is found in Dr. Thomas Clarkson's, ``The Three 
     Modern Faces of Mercury'':
       ``The first methylmercury compounds were synthesized in a 
     chemical laboratory in London in the 1860s. Two of the 
     laboratory technicians died of methylmercury poisoning. This 
     so shocked the chemical community that methylmercury 
     compounds were given a wide berth for the rest of the century 
     . . . early in the twentieth century the potent anti-fungal 
     properties . . . were discovered, leading to applications to 
     seed grains, especially for cereal crops . . . . Despite the 
     widespread use, few cases of poisoning were reported for the 
     first half of the twentieth century. However, in the late 
     1950s and 1960s serious outbreaks of alkyl mercury poisoning 
     (methylmercury) erupted in several developing countries . . . 
     Also in the late 1950s, evidence emerged of environmental 
     damage from treated grain. It was observed in Sweden that 
     predatory birds were developing neurological disorders . . . 
     analysis . . . indicated a sharp rise in mercury levels.''
       Public health concerns about methylmercury in the edible 
     tissue of fish suddenly erupted in 1969 when fish from Lake 
     St. Clair bordering Michigan were found to have high levels. 
     This and other findings . . . have maintained public health 
     concerns over this form of mercury.''
       As a result of these emerging concerns, public health 
     officials worldwide began researching methylmercury. Today, 
     the scientific literature is replete with evidence on toxic 
     effects of methylmercury. In 2000, the National Academy of 
     Sciences published Toxicological Effects of Methylmercury, 
     which concluded:
       Methylmercury is highly toxic.
       The data indicate that the adverse effects of methylmercury 
     exposure can be expressed in multiple organ systems 
     throughout the lifespan.
       The research in humans on the neurodevelopmental effects of 
     methyl-
     mercury is extensive.
       Damage to renal tubules and nephron has been observed 
     following human exposure to inorganic and organic forms of 
     mercury. Symptoms of renal damage have been seen

[[Page 12723]]

     only at mercury exposures that also caused neurological 
     effects.
       The cardiovascular system appears to be a target for 
     methylmercury toxicity in the same dose range as 
     neurodevelopmental effects--at very low mercury exposures.
       Studies in humans on the carcinogenic effects of 
     methylmercury are inconclusive.
       Methylmercury may increase human susceptibility to 
     infectious disease and autoimmune disorders by damaging the 
     immune system.
       Methylmercury may adversely affect the reproductive system.
       The medical literature is replete with references to the 
     dangers to methylmercury:
       ``The major toxic effects of methylmercury are on the 
     central nervous system. Its toxic action on the developing 
     brain differs in both mechanism and outcome from its action 
     on the mature organ . . . the action of methylmercury on 
     adults is characterized by a latent period between exposure 
     and onset of symptoms. The period can be several weeks or 
     even months, depending on the dose and exposure period . . . 
     paresthesia, numbness or a `pins and needles' sensation is 
     the first symptom to appear at the lowest dose. This may 
     progress to cerebella ataxia, dysarrthia, constriction of the 
     visual fields, and loss of hearing. . . . Cardiovascular 
     disease . . . accelerated progression of carotid 
     arteriosclerosis.''
       The research is explicit that fetal brains are more 
     sensitive than the adult brains to the adverse effects of 
     methylmercury, which include:
       Severe brain damage
       Delayed achievement of developmental milestones
       Neurological abnormalities such as brisk tendon reflexes
       Widespread damage to all areas of the fetal brain, as 
     opposed to focal lesions seen in adult tissue
       Microcephaly
       Purkinje [neuron] cells failed to migrate to the cerebellum
       Inhibition of both cell division and migration, affecting 
     the most basic process in brain development
       Additionally, elevation in both systolic and diastolic 
     blood pressure in seven year olds correlated with prenatal 
     exposure to methylmercury . . . indicative of later 
     cardiovascular problems.
       Despite the fact that ethylmercury has been widely used in 
     common medical treatments, ranging from vaccines to nasal 
     sprays to ointments, comparatively little research has been 
     done on its health effects. The few studies that have been 
     done tend to indicate that ethylmercury is just as toxic as 
     methylmercury.
       The FDA never required the pharmaceutical industry to 
     conduct extensive safety studies on thimerosal or 
     ethylmercury. It appears that our Federal regulatory 
     framework (the FDA and its predecessor organizations) failed 
     to require manufacturers to prove thimerosal was safe. They 
     failed to require industry to conduct adequate testing to 
     determine how thimerosal is metabolized. The FDA failed to 
     require that industry conduct studies to determine the 
     maximum safe exposure level of thimerosal. These basic issues 
     should have been proven prior to the introduction of 
     thimerosal into the marketplace, but more than 70 years after 
     its introduction, these issues have still not been adequately 
     addressed. The introduction of thimerosal appears to have 
     been based on a single uncontrolled and poorly reported human 
     study in the 1920s, possibly in combination with animal and 
     laboratory studies. However, this sole human study was not a 
     true safety study and produced a faulty foundation on which 
     to build a robust vaccine program in which young children 
     would be forced to be repeatedly injected with multiple doses 
     of ethylmercury.
       During the pre-antibiotic 1920's, meningitis was a killer. 
     Out of sheer desperation, the treating physician at a 
     hospital dealing with dozens of patients facing a sure death 
     from meningitis, tested thimerosal on about two-dozen 
     patients. He injected the thimerosal intravenously, without 
     apparent side effects. However, the treatment was not 
     successful and all of the patients died. The leading industry 
     scientists of that era involved in thimerosal research 
     published a paper that made a brief reference to this study: 
     ``Merthiolate was injected intravenously into 22 persons . . 
     . these large doses did not produce any anaphylactoid or 
     shock symptoms.'' In the paper, the authors acknowledge that 
     Dr. K.C. Smithburn, the clinician who treated the meningitis 
     patients, was not convinced of its efficacy: ``beneficial 
     effects of the drug were not definitely proven.'' Drs. Powell 
     and Jamieson also noted in 1930 that a ``wide range of 
     toxicity and injury tests should be done.'' There is no 
     evidence that Drs. Powell and Jamieson took their own advice 
     and conducted studies to address these concerns.
       As a result, in 1999, 70 years after the product was first 
     licensed, neither the FDA nor the industry had followed 
     through on determining a safe exposure level to thimerosal or 
     ethylmercury. Thus, when facing a policy decision on 
     thimerosal and vaccines, the FDA had to work from an 
     ``assumption'' that the toxicity of ingested methylmercury 
     was the same as injected ethylmercury.
       One study that compared the toxicology of ethyl and 
     methylmercury was published in 1985 in the Archives of 
     Toxicology, written by researchers from the Toxicology Unit 
     of the Medical Research Council of England. The researchers 
     exposed rats to ethyl and methylmercury to ``compare total 
     and inorganic mercury concentrations in selected tissues, 
     including the brain, after the daily administration of methyl 
     or ethylmercury and to relate these findings to damage in the 
     brain and kidneys.'' This study found that both ethyl and 
     methylmercury caused damage to the brains and the kidneys. It 
     also found that male and female rats were affected 
     differently:
       ``It has been well documented that one of the first toxic 
     effects of methylmercury in rats is depressed weight gain or 
     even weight loss . . . based on this criteria, ethylmercury 
     proved to be more toxic than methylmercury . . . in both 
     sexes . . . the concentration of total mercury (the sum of 
     organic and 
     inorganic mercury) and organic mercu-
     ry was consistently higher in the blood 
     of ethylmercury-treated rats . . . both alkymercurials 
     damaged the dorsal root ganglia and 9.6 mg Hg/kg/day 
     ethylmercury caused more damage than 8.0 mg Hg/kg/day 
     methylmercury. Ethylmercury was more renotoxic than 
     methylmercury . . . tubular dilation was frequently present . 
     . . in kidneys . . . both damage and mercury deposits were 
     more widely spread in ethylmercury-treated rats.''
       While there is frequent reference to the paucity of science 
     in understanding the harm that ethylmercury can do, there is 
     more understanding in the scientific community than 
     government officials have shared with the Committee. The 
     following dialogue between Congressman Dave Weldon (R-FL) and 
     Dr. David Baskin during the Committee's December 10, 2002 
     hearing sheds a great deal of light onto the true nature of 
     ethyl versus methylmercury.
       Dr. Weldon: ``I have a couple of questions for Dr. Baskin 
     about ethylmercury versus methylmercury. I have had some 
     people say that data on methylmercury is fairly good, but we 
     don't have good data on ethylmercury. I take it from your 
     testimony there is actually quite a bit of data on 
     ethylmercury and it's as toxic as methylmercury.''
       Dr. Baskin: ``There is more data, more and more data on 
     ethylmercury. The cells that I showed you dying in cell 
     culture are dying from ethylmercury. Those are human frontal 
     brain cells. You know, there has been a debate about . . . 
     ethyl versus methyl. But from a chemical point of view, most 
     chemical compounds that are ethyl penetrate into cells better 
     than methyl. Cells have a membrane on them, and the membrane 
     is made of lipids, fats. And ethyl as a chemical compound 
     pierces fat and penetrates fat much better than methyl. And 
     so, you know, when I began to work with some of the Ph.D.s in 
     my laboratory and discuss this everyone said, `oh gosh, you 
     know, we've got to adjust for ethyl because it's going to be 
     worse; the levels are going to be much higher in the cells.' 
     So . . . I think at best they're equal, but it's probably 
     highly likely that they are worse. And some of the results 
     that we are seeing in cell culture would support that.''
       Dr. Baskin explained that according to scientific research 
     in humans and animals, brain tissue absorbs five times more 
     mercury than other tissues in the body.
       Dr. Weldon: ``Now, you said several times in your testimony 
     that uptake in the brain is probably much higher than in 
     other tissues. What do you base that statement on?''
       Dr. Baskin: ``Well, the literature on methylmercury is much 
     better than ethyl on this issue. And if you look at the 
     studies, the brain is 2 percent of the body weight but took 
     10 percent of the exposure. So that's a five-fold 
     preferential uptake.''
       The testimony of Dr. Baskin builds upon earlier testimony 
     that the Committee received from recognized experts in 
     chemistry, toxicology and pharmacology. It includes the 
     following statement from Dr. H. Vasken Aposhian, Professor of 
     Molecular and Cellular Biology, and Pharmacology at the 
     University of Arizona, who provided the Committee the 
     following information about the evidence on mercury toxicity 
     at the July 18, 2000 hearing:
       ``The mercury amalgams in your mouth, the so-called silver 
     fillings, contain 48 to 50 percent of elemental mercury. 
     These fillings continuously emit mercury vapor, which will go 
     to the brain and is converted to mercuric mercury . . . . 
     Certain fish contain methylmercury; again, very rapidly taken 
     up from the GI tract, transported quickly to the brain, and 
     converted very slowly to mercuric mercury . . . thimerosal, 
     which again will be taken up by the brain and quickly 
     converted to mercuric mercury--all three forms are 
     neurotoxic.
       ``By neurotoxic, we mean it will damage nerves and it will 
     damage brain tissues.
       ``Let me just say as a final statement that there is no 
     need to have thimerosal in a vaccine.''
       In making a presentation to the Institute of Medicine's 
     Immunization Safety Review Committee, in July 2001, the 
     former Director of the Environmental Toxicology Program at 
     the National Institutes of Health, Dr. George Lucier, 
     proffered the following conclusions:

[[Page 12724]]

       Ethylmercury is a neurotoxin.
       Infants may be more susceptible than adults.
       Ethylmercury should be considered equipotent to 
     methylmercury as a developmental neurotoxin. This conclusion 
     is clearly public health protective.
       Ethylmercury exposure from vaccines (added to dietary 
     exposures to methylmercury) probably caused neurotoxic 
     responses (likely subtle) in some children.
       While the debate over whether ethyl or methylmercury is 
     more toxic will probably not be resolved in the near future, 
     a consensus appears to be emerging that exposure to these 
     different types of mercury cannot be considered in isolation. 
     Rather, witnesses before the Committee stressed that in 
     determining safe levels of mercury exposure, the cumulative 
     level of exposure to all types of mercury must be considered. 
     Dr. Jeffrey Bradstreet made the following observation at the 
     July 19, 2002 hearing:
       ``More concerning to me in the Institute's treatment of 
     mercury problems, was the almost complete absence of regard 
     for compounding effect of thimerosal on preexisting mercury 
     levels. The NHANES Study from the CDC had already established 
     that perhaps one in ten children is born to mothers with 
     elevated mercury burden.''

   D. Because of its toxicity, mercury has become heavily regulated.

       As the dangers of mercury have become better understood, 
     the United States and other governments around the world have 
     taken actions to reduce the release of mercury into the 
     environment. In 1972, the federal government halted the use 
     of mercury compounds for many industrial uses, such the paint 
     used on the hulls of ships and compounds used to prevent the 
     growth of fungi in lumber, because the mercury had leached 
     into the environment and found its way into the human food 
     chain.
       In 1972, while certain agencies within the federal 
     government recognized that mercury was a cumulative poison 
     that damaged brain cells, the FDA's vaccine division seems to 
     have ignored the issue until 1999.

  1. The EPA is Regulating the Release of Mercury Into the Environment

       The Environmental Protection Agency (EPA) under the Clean 
     Air Act regulates airborne emissions of mercury. In December 
     2000, the EPA announced that it would issue new regulations 
     on the emissions of mercury from coal and oil-fired power 
     plants. That action was taken because, ``mercury has been 
     identified as the toxic of greatest concern among all the air 
     toxics emitted from power plants.''
       More recently, President Bush announced on February 14, 
     2002, that mercury emissions from power plants would be 
     reduced 69% under his Clear Skies Initiative. Under this 
     plan, mercury emissions would be reduced from the current 
     level of 48 tons nationally to 15 tons by 2018. The EPA also 
     regulates mercury emissions from municipal waste combustors, 
     medical waste incinerators, and hazardous waste incinerators.
       The EPA works both domestically and internationally to 
     reduce mercury exposures in the environment. The ``Canada-
     United States Strategy for the Virtual Elimination of 
     Persistent Toxic Substances in the Great Lakes Basin'' is an 
     example of these activities.

  2. Different Limits to Exposure to Mercury Have Been Established by 
                           Different Agencies

       In the course of regulating mercury, different government 
     agencies have established different minimum risk levels for 
     daily exposure to mercury. Exposure to less than the minimum 
     risk level is believed to be safe, while exposure that 
     exceeds that level is believed to increase the chances of 
     injury. All of the levels apply specifically to ingested 
     methylmercury.
       The EPA established the most conservative level: 0.1 
     micrograms of mercury per kilogram of body weight per day. 
     Under this standard, an 11-pound baby (roughly 5 kilograms) 
     could be exposed to up to 0.5 micrograms of mercury per day 
     and be considered safe. This exposure standard is a marked 
     contrast to the 25 micrograms of mercury that was contained 
     in several childhood vaccines until very recently.
       The most lenient federal minimum risk level for mercury is 
     the FDA's, which sets its limit at 0.4 micrograms per 
     kilogram of body weight per day. (The United Nations' World 
     Health Organization sets a slightly higher limit of 0.47 
     micrograms per kilogram of bodyweight per day.) Falling in 
     between is the U.S. Agency for Toxic Substances and Disease 
     Registry (ATSDR) at 0.3 micrograms.
       In 2000, the National Academy of Sciences issued a report 
     titled, Toxicological Effects of Methylmercury, validating 
     the EPA's lower limit as a ``scientifically appropriate level 
     that adequately protects the public.''

------------------------------------------------------------------------
                        Methylmercury guidelines
-------------------------------------------------------------------------
                               Guideline
                               value for
                                maximum
                                 daily
                              consumption
                              (g/kg/day)
           Agency             (micrograms         Guideline `type'
                             per kilogram
                                  of
                              bodyweight
                               per day)
 
------------------------------------------------------------------------
EPA                              0.1       Reference dose (RfD).
ATSDR                            0.3       Minimal risk level.
FDA                              0.4       Tolerable daily intake.
WHO                             0.47       Provisional daily tolerable
                                            intake (converted from a
                                            weekly tolerable intake).
------------------------------------------------------------------------

       The Committee repeatedly heard from government officials 
     that merely exceeding the guideline was not cause for 
     concern. One Merck official, in teaching a Grand Rounds 
     session to staff in November of 1999, postulated that the 
     minimum risk level would need to be multiplied by ten to 
     reach a level at which harm would be expected through 
     exposure. Dr. Roberta McKee of Merck wrote:
       ``A number of environmental and public health agencies have 
     set a Minimum Risk Level (MRL) for toxic substances. An MRL 
     for ingestion is conceptually equivalent to the Reference 
     Dose of the US Environmental Protection Agency, the 
     Acceptable Daily Intake of the US FDA, and the Tolerable 
     Daily Intake of the WHO. Any exposure to the substance below 
     the MRL is assured to be safe, while exposure to ten times 
     the MRL is assumed to place one at risk of overdose. Exposure 
     at or near the MRL is assumed to be safe but should trigger 
     deliberate and careful review.''
       Based on Dr. McKee's explanation, many babies were exposed 
     to levels of mercury that ``placed one at risk of overdose,'' 
     and were exposed to amounts well over ten times the EPA's 
     scientifically validated reference dose. For example, at a 
     recent Committee hearing, Chairman Dan Burton (R-IN) 
     discussed his own family's experience with vaccine injuries:
       ``My grandson received vaccines for nine different diseases 
     in one day. He may have been exposed to 62.5 micrograms of 
     mercury in one day through his vaccines. According to his 
     weight, the maximum safe level of mercury he should have been 
     exposed to in one day is 1.5 micrograms, so that is 41 times 
     the amount at which harm can be caused.''
       According to the analysis of Dr. McKee, based on the 
     methylmercury ingestion guidelines, the Chairman's grandson 
     would have exceeded the ``ten times the MRL'' and therefore 
     was placed ``at risk of overdose.'' In fact, with a 62.5 
     microgram exposure alone, the EPA, ATSDR, and FDA levels 
     would have been exceeded by 10 times. Because the FDA chose 
     not to recall thimerosal-containing vaccines in 1999, in 
     addition to all of those already injured, 8,000 children a 
     day continued to be placed ``at risk for overdose'' for at 
     least an additional two years.
       It should also be noted that none of the Federal guidelines 
     on mercury exposure have been included specific provisions 
     for safe exposure limits for infants and children. It is 
     widely accepted that infants and young children would be five 
     times more sensitive to the toxic effect of mercury or other 
     neurotoxins than adults. ``Exposures early in life are 
     reasonably of greater health concern . . . because of greater 
     brain organ susceptibility.''
       The FDA has conceded in recent years that many children 
     received doses of ethylmercury through their vaccinations 
     that exceeded the EPA's minimal risk level for methylmercury. 
     However, it is also clear that many infants received doses of 
     ethylmercury that exceeded the FDA's higher threshold.

         3. Warnings Have Been Issued About Mercury in Seafood

       The FDA's actions regarding the risk of medical exposures 
     to mercury have differed greatly from their actions regarding 
     food exposures to mercury. The agency has a long history of 
     issuing warnings to the public to monitor their fish 
     consumption due to concerns about mercury exposure. During 
     the 1990's, the FDA repeatedly issued warnings advising 
     pregnant women and young children to avoid certain fish, or 
     to limit their consumption of these fish because of their 
     mercury content. In September of 1994, the FDA issued an 
     advisory entitled, ``Mercury in Fish: Cause for Concern?'' in 
     which they stated:
       ``Swordfish and Shark taste great--especially grilled or 
     broiled. But reports which state that these and other large 
     predatory fish may contain methylmercury levels in excess of 
     the Food and Drug Administration's 1 part per million (ppm) 
     limit has dampened some fish lover's appetites . . . `there 
     is no doubt that when humans are exposed to high levels of 
     methylmercury that poisoning and problems in the nervous 
     system can occur' . . . the types of symptoms reflect the 
     degree of exposure . . . .
       ``During prenatal life, humans are susceptible to the toxic 
     effects of high methylmercury exposure because of the 
     sensitivity of the developing nervous system . . . . 
     Methylmercury easily crosses the placenta, and the mercury 
     concentration rises to 30 percent higher in fetal red blood 
     cells than in those of the mother . . . none of the studies 
     of methylmercury poisoning victims have clearly shown the 
     level at which newborns can tolerate exposure . . . . 
     Pregnant women and women of child bearing age, who may become 
     pregnant, however, are advised by FDA experts to limit their 
     consumption of shark and swordfish to no more than once a 
     month.''
       Similarly, a March 2001 FDA advisory states:
       ``Some fish contain high levels of a form of mercury called 
     methylmercury that can harm an unborn child's developing 
     nervous

[[Page 12725]]

     system if eaten regularly. By being informed about 
     methylmercury and knowing the kinds of fish that are safe to 
     eat, you can prevent any harm to your unborn child and still 
     enjoy the health benefits of eating seafood. . . . While it 
     is true that the primary danger from methylmercury in fish is 
     to the developing nervous system of the unborn child, it is 
     prudent for nursing mothers and young children not to eat 
     these fish as well.''
       In addition to the public advisories, the FDA, in January 
     of 2001, established an aggressive ``Education Plan on Methyl 
     Mercury.'' In January 2001, Associate FDA Commissioner 
     Melinda Plaiser, responding to Congressman William J. Coyne 
     (D-PA) regarding the National Academy of Sciences' report on 
     Methylmercury, wrote:
       ``[L]et me reiterate, the FDA's commitment to protecting 
     the public's health and the environment regarding mercury.''
       Furthermore, in their training materials for employees, the 
     FDA reflects a slightly different emphasis on mercury's 
     toxicity than what they presented to the Committee:
       ``People are exposed every day to a tremendous number of 
     substances in our environment. These substances include major 
     and trace elements that may or may not be essential for 
     sustaining life . . . . Other elements are not known to be 
     essential but are constantly found in living tissues . . . . 
     Of these elements that have no known nutritional value, some 
     have been found to be toxic at concentrations well below 
     those of other nonessential elements. Lead, cadmium, and 
     mercury are examples of elements that are toxic when present 
     at relatively low levels.''
       Other HHS entities have taken very strong mercury reduction 
     positions. For example, the National Institutes of Health's 
     (NIH) Division of Safety has initiated a program to make the 
     NIH mercury-free. According to the Division's own website:
       ``Elemental (metallic) mercury and its compounds are toxic 
     and exposure to excessive levels can permanently damage or 
     fatally injure the brain and kidneys. Elemental mercury can 
     also be absorbed through the skin and cause allergic 
     reactions. Ingestion of inorganic mercury compounds can cause 
     severe renal and gastrointestinal toxicity. Organic compounds 
     of mercury such as methylmercury are considered the most 
     toxic forms of the element. Exposures to very small amounts 
     of these compounds can result in devastating neurological 
     damage and death.
       ``For fetuses, infants, and children, the primary health 
     effects of mercury are on neurological development. Even low 
     levels of mercury exposure, such as result from a mother's 
     consumption of methylmercury in dietary sources, can 
     adversely affect the brain and nervous system. Impacts on 
     memory, attention, language and other skills have been found 
     in children exposed to moderate levels in the womb.
       ``The Campaign for a Mercury Free at the NIH seeks to 
     eliminate, as far as possible, the use of mercury in NIH 
     facilities; to encourage the use of safer alternatives in 
     biomedical research; to increase general awareness of mercury 
     hazards; and to prevent mercury pollution.''
       This NIH program has initiated a ``Hatters Pledge'' program 
     to recruit scientists to reduce the use of mercury at the NIH 
     and to educate children on the dangers of mercury.
       The NIH Hatters Pledge:
       I will:
       Improve my awareness of mercury hazards and how to reduce 
     them.
       Replace mercury thermometers and other mercury-containing 
     items with non- or low-mercury alternatives if suitable 
     alternatives are available.
       Dispose of mercury wastes following NIH procedures.
       Report spills of mercury.
       On the NIH campus, call the Fire Department (911) who are 
     the NIH hazardous material (HAZMAT) emergency responder.
       Off campus, call the local fire department or facility's 
     hazardous material (HAZMAT) emergency responder.
       Have areas that might have been contaminated by mercury 
     surveyed and decontaminated, if necessary.

4. Over the Course of Two Decades, the FDA Slowly Removed Ethylmercury 
                      From Many Medicinal Products

       In 1980, the FDA began a lengthy regulatory process to 
     remove ethylmercury products from over-the counter products 
     like topical ointments, diaper rash creams, and 
     contraceptives. Topical ointments are products used on the 
     skin either for the treatment or prevention of skin 
     infections or inflammatory processes. They are typically 
     divided into four categories, first-aid products to be 
     applied to small superficial wounds to prevent infection; 
     skin wound protectant to provide a protective barrier to 
     small wounds; antibiotic or antifungal creams to prevent or 
     treat overt skin infection; and anti-inflammatory agents used 
     to reduce inflammation and inhibit pruritis.
       In 1980, the FDA asked their Over-the-Counter (OTC) Review 
     Panel to conduct a massive review of OTC products. The panel 
     opted to divide the task into categories, one of which was a 
     review of OTC products containing ethylmercury.
       As a result of the panel's work, in 1982, the FDA issued a 
     proposed rule to ban thimerosal from OTC topical ointments. 
     In addition to raising questions about the general 
     effectiveness of thimerosal for preventing infections, the 
     FDA found that thimerosal was too toxic for OTC use. Among 
     the findings that they published were the following:
       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 (mercuri-
     chrome).
       It was found to be 35.3 times more toxic for embryonic 
     chick heart tissue than for staphylococcus aureus.
       Delayed hypersensitivity in 50 percent of the guinea pigs 
     tested, indicating that thimerosal is highly allergic and 
     that it is reasonable to expect humans to be equally 
     allergic.
       The FDA concluded that while it has been suggested that 
     hypersensitivity may be due to the thiosalicylate portion of 
     the molecule and not the ethylmercury, this was not 
     confirmed.
       They noted a Swedish study which found in healthy subjects 
     the following levels of hypersensitivity to thimerosal: 10% 
     of school children; 16% of military recruits; 18% of twins, 
     and 26% of medical students.
       In 1982, the FDA advisory panel concluded that thimerosal 
     was not generally recognized as safe: ``The Panel concludes 
     that thimerosal is not safe for OTC 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 bacteriostatic action can be 
     reversed.''
       Despite this strong finding, the FDA's proposed ban on the 
     OTC use of thimerosal was not finalized until 1998, 18 years 
     later. At the time of the OTC review, the industry chose not 
     to challenge the findings of the Panel regarding the toxicity 
     of thimerosal in OTC products. It is unclear why the FDA 
     chose to do nothing for 18 years after a ``not generally 
     recognized as safe'' finding.
       Although the FDA went through that 18-year regulatory 
     process to remove thimerosal from topical ointments, 
     apparently no one at the FDA was prompted to review the use 
     of thimerosal in vaccines. Action to remove thimerosal from 
     vaccines did not begin until 1999, in response to the 
     Congressionally mandated review. This will be discussed in 
     more detail later in this report.
       At the time of the 1999 FDA review on thimerosal, it was 
     learned that over 50 vaccines contained thimerosal. On July 
     9, 1999, the American Academy of Pediatrics joined the U.S. 
     Public Health Service in issuing a joint statement 
     recommending the removal of all thimerosal from vaccines. On 
     its website, the FDA provides the following rationale for its 
     policy on thimerosal:
       ``Over the past several years, because of an increasing 
     awareness of the theoretical potential for neurotoxicity of 
     even low levels of organomercurials, and because of the 
     increased number of thimerosal-containing vaccines that have 
     been added to the infant immunization schedule, concerns 
     about the use of thimerosal in vaccines and other products 
     have been raised. Indeed, because of these concerns, the Food 
     and Drug Administration has worked with, and continues to 
     work with, vaccine manufacturers to reduce or eliminate 
     thimerosal from vaccines.''
       In 1999, the FDA was criticized by some for not taking more 
     forceful action to remove thimerosal from vaccinations; as a 
     result of the FDA decision to seek a gradual removal, many 
     children continued to receive injections of the DTaP, Hib, 
     and Hepatitis B vaccine that contained mercury well into 
     2001. Mercury-containing vaccines manufactured in the United 
     States, up to today, continue to be administered to infants 
     and small children in the United States and abroad.

          E. Thimerosal is still used in some medical products

       While the FDA has taken steps over the last 20 years to 
     remove ethylmercury from topical ointments and most pediatric 
     vaccines, a number of medical products continue to contain 
     this preservative.
       Some nasal and ophthalmic products containing thimerosal 
     remain on the market.
       About 75 percent of the flu vaccines, recently recommended 
     to be given to children as young as six months, contain at 
     least trace amounts of thimerosal.
       Many adult vaccines contain thimerosal.
       Vaccines containing thimerosal continue to be manufactured 
     in the United States and delivered through the World Health 
     Organization (WHO) to Third World Countries. The WHO has 
     continued to require the use of multi-dose vials and to use 
     preservatives, including thimerosal, to address storage and 
     transportation issues.
       Of additional concern to the Committee, but not discussed 
     in detail within this report, is the continued use of 
     thimerosal in adult vaccines. There is a growing emphasis on 
     adult immunizations, including getting boosters to childhood 
     immunizations. Additionally, all new military recruits, 
     active duty, and reserve forces that are deploying overseas 
     are routinely given a large number of vaccines, many 
     containing ethylmercury. These vaccines are often given 
     consecutively and all in the same day.

[[Page 12726]]



                                                             U.S. MILITARY VACCINE SCHEDULE
--------------------------------------------------------------------------------------------------------------------------------------------------------
             Vaccine                   No. Doses         Initial entry       Troops in US          Deployed         Region or other   Thimerosal content
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anthrax.........................  6 + annual........  N/A...............  N/A...............  6 + annual........  6 + annual........  0
DtaP............................  N/A...............  N/A...............  N/A...............  ..................  ..................  0 (or 0.5 mcg/
                                                                                                                                       dose)
Hib.............................  N/A...............  N/A...............  N/A...............  ..................  (People without     0
                                                                                                                   spleens).
Hep A...........................  3 + boosters......  N/A...............  3 + boosters......  3 + boosters......  3 + boosters......  0
Hep B...........................  3.................  3.................  3.................  3 (Korea).........  3 (Korea), Health   0 (or 0.5 mcg/
                                                                                                                   Care Workers,       dose)
                                                                                                                   STDs.
Influenza A&B...................  1 Annual..........  1.................  1 annual..........  1 Annual..........  1 Annual (Health    25 mcg/dose or
                                                                                                                   workers).           24.5, mcg/dose or
                                                                                                                                       1, mcg/dose or
                                                                                                                                       .98 mcg/dose
Jap Enceph......................  3 + biannual        N/A...............  N/A...............  3 + biannual        3 + biannual        35 mcg per 1 mL
                                   boosters.                                                   boosters.           boosters (Travel    dose or 17.5 mcg/
                                                                                                                   Rural Asia).        0.5 mL dose
MMR (Live)......................  1.................  1.................  N/A...............  Seldom needed.....  NA (Health          0
                                                                                                                   workers).
Meningococcal MGC...............  1 every 3 years...  1.................  N/A...............  Within 3 years....  Travel to mid-      25 mcg/dose
                                                                                                                   Africa, Arabia.
Pneumococcal 17; PCBV-7.........  N/A...............  N/A...............  N/A...............  N/A...............  N/A...............  0
Pneumococcal 123; PPV-23........  1.................  1 (Pendleton).....  N/A...............  N/A...............  (No spleen, other   0 or 25 mcg/dose
                                                                                                                   chronic diseases).
Polio Inactivated IPV...........  1 booster dose....  1.................  N/A...............  ..................  (Travel Africa      0
                                                                                                                   Asia).
Rabies..........................  Pre:(3 doses +      N/A...............  N/A...............  ..................  (Veterinary bites)  0
                                   booster).
Smallpox (Live).................  1 every 10 years..  N/A...............  1.................  1.................  1.................  0
Td; TT (25 mcg).................  1 every 10 years..  1.................  1 every 10 years..  1 every 10 years..  1 every 10 years..  8 mcg/dose or 25
                                                                                                                                       mcg/dose.
Typhoid Injectable..............  1 every 2 years...  N/A...............  1 every 2 days....  Every 2 years.....  Every 2 years       0
                                                                                                                   (travel).
Varicella (Live)................  2 doses if needed.  Screen, 2 doses...  N/A...............  N/A...............  N/A...............  0
Yellow Fever (Live).............  1 every 10 years..  (N, MC) 1.........  1 every 10 years..  1 every 10 years..  1 every 10 years    0
                                                                                                                   (travel Africa,
                                                                                                                   Pacific, South
                                                                                                                   Am).
Possible Total Thimerosal         ..................  ..................  ..................  110.5 mcg per shot  135.5 mcg per shot  ..................
 Exposure.                                                                                     day.                day.
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (EPA Safety Limit: 0.1 mcg/kg of body weight per day)
       The Committee calculated the bolus dose exposure of adult 
     males and females below:
     Adult weight with exposure rates according to EPA Safety 
         Limit
     100 pound: 0.1 mcg/45.359 kg of body weight per day = 4.54
     120 pound: 0.1 mcg/54.431 kg of body weight per day = 5.44
     150 pound: 0.1 mcg/68.039 kg of body weight per day = 6.8
     180 pound: 0.1 mcg/81.647 kg of body weight per day = 8.16

       It is clear from this chart that with a maximum safe limit 
     of 8.16 micrograms in a day, individuals receiving either 
     110.5 micrograms or 135.5 micrograms in one day may be at 
     risk for injury from mercury exposure. Even in keeping with 
     the safety margin of 10 times the safety limit, purported by 
     Dr. Roberta McKee of Merck, individuals at each of these 
     weights would be exposed to levels of mercury that would be 
     expected to put them at risk for adverse reactions.
       The Committee received documentation from one Air Force 
     pilot who suffered from serious symptoms of Gulf War 
     Syndrome. After failing to have his medical issues resolved 
     through the military or the Veterans Administration (VA) 
     medical system, Captain Frank Schmuck, a pilot, became so ill 
     that he was no longer able to fly. He sought medical 
     treatment outside the military medical system and was tested 
     for heavy metals, and was found to have toxic levels of 
     mercury in his system. After chelation therapy, he returned 
     to good health and has resumed flying. Gulf War Syndrome 
     victims are not routinely tested for heavy metal toxicity or 
     treated with chelation therapy by the military or the VA. 
     Given the lack of progress in finding other successes with 
     recovery from this condition, this is an issue that both the 
     Department of Defense (DOD) and the VA should be aggressively 
     evaluating on behalf of Gulf War veterans.


  IV. There Are Growing Questions About Whether Mercury In Childhood 
            Vaccines Is Related To Autism Spectrum Disorders

              A. Autism Is Growing at Epidemic Proportions

                            1. Introduction

       Autism was once considered a rare disease that affected an 
     estimated 1 in 10,000 individuals in the United States. The 
     Committee held its first hearing on the dramatic rise in 
     autism in April of 2000. At the time, Federal agencies were 
     estimating that autism affected 1 in 500 children in the 
     United States. By 2002, the National Institutes of Health had 
     adjusted that rate to 1 in 250 children in the United States. 
     The Autism Society of America estimates that the number of 
     autistic children is growing by 10 to 17 percent each year.
       In that first hearing, Chairman Burton reported that 
     according to U.S. Department of Education statistics, 
     requests for services for school-age children with autism 
     spectrum disorders had risen dramatically in every state.
       Mr. Burton: ``California has reported a 273 percent 
     increase in children with autism since 1988 . . . . Florida 
     has reported a 571 percent increase in autism. Maryland has 
     reported a 513 percent increase between 1993 and 1998 . . . . 
     In 1999, there were 2,462 children ages 3 to 21 in Indiana 
     diagnosed with autism. That is one-fourth of 1 percent of all 
     the school children in Indiana, or 1 out of every 400 . . . . 
     This increase is not just better counting. If we want to find 
     a cure, we must first look to the cause.''
       In July 2000, Dr. Stephanie Cave shared her observations 
     about the rapid growth of autism and the pressures it is 
     placing on families and medical professionals:
       ``I am in family practice in Baton Rouge, LA. I want to 
     express my deep appreciation to you and to the members of the 
     committee for allowing me to testify. I am presently treating 
     over 300 autistic children, with an additional 150 waiting to 
     get in.
       ``We are treating children from all over the United States 
     and getting calls from many places around the globe. This is 
     truly an epidemic. If you have any idea that it is not, I 
     invite you to sit in my office for 2 hours.''

       2. Studies Are Documenting the Incredible Growth of Autism

       In the 1990's, the CDC conducted two prevalence studies 
     that confirmed dramatic spikes in autism cases. One was 
     conducted in Brick Township, New Jersey, the other in 
     Atlanta, Georgia.
       In late 1997, after noticing an apparently larger than 
     expected number of children with autism in their community, a 
     citizen's group in Brick Township, New Jersey, contacted the 
     New Jersey Department of Health and Senior Services (DHSS). 
     Because of the complexity of the disorder and the concerns 
     that environmental factors might play a role, the New Jersey 
     DHSS, U.S. Senator Robert Torricelli, and U.S. Representative 
     Christopher Smith contacted the CDC and the ATSDR for 
     assistance. In response, the CDC conducted an extensive 
     prevalence investigation.
       The rate of autism among children in Brick Township was 4 
     per 1,000 (1 in 250) children aged 3 through 10 years. The 
     prevalence of the more broadly defined autism spectrum 
     disorder was 6.7 per 1,000 (1 in 150) children. It is 
     important to note that even though the families of Brick 
     Township requested that the CDC include an evaluation of a 
     possible link between autism and their children's 
     immunization, the CDC chose not to do so. Their evaluation of 
     the cause of the cluster of autism in Brick Township was 
     inconclusive.
       The CDC's Atlanta study confirmed the dramatic results of 
     the Brick Township study. The CDC found that 1,987 of the 
     289,456 children aged 3 to 10 years in metropolitan Atlanta 
     in 1996 were autistic (1 in 146). These numbers were 10 times 
     higher than studies conducted in the 1980s and early 1990s.
       Last November, a study on autism in California determined 
     that the number of autistic individuals in that state has 
     nearly tripled. Equally important, the study stated that the 
     increase was real, and could not be explained by changes in 
     diagnostic criteria or better diagnoses. The study, funded by 
     the state legislature and conducted by the University of 
     California at Davis, determined that the number of autistic 
     people in that state grew by 273% between 1987 and 1998.
       The main author of the study, Dr. Robert Byrd, said, ``It 
     is astounding to see a three-fold increase in autism with no 
     explanation . . . there's a number of things that need to be 
     answered. We need to rethink the causes of autism.''
       The 2002 report confirmed a 210 percent increase in the 
     number of new children professionally diagnosed with the most 
     severe cases of autism entering the developmental services 
     system between 2001 and 2002. The system added 3,577 new 
     cases in 2002.
       It is important to note that the figures reported in 
     California do not include persons with Pervasive 
     Developmental Disorder (PDD), PDD-Not Otherwise Specified 
     (PDD-NOS), Asperger's Syndrome, or any of the other milder 
     autism spectrum disorders. The California data reflect only 
     those children who have received a professional diagnosis of 
     level one, DSM IV autism--the most severe form of autism.

[[Page 12727]]



           3. The Causes of the Autism Epidemic Are Not Known

       The underlying causes of the explosion in autism remains a 
     mystery. While the medical community has made many advances 
     over the years in developing treatments and better diagnostic 
     tools, little progress has been made in understanding why 
     some children become autistic.
       Mr. Waxman: ``Autism is a particularly frustrating disease. 
     We still do not understand what causes it and we still do not 
     have a cure. All we know for sure is that its impact on 
     families can be devastating. During the hearings held in this 
     committee, we have heard parents tell tragic stories of 
     children who appear to be developing normally and then all of 
     a sudden retreat into themselves, stop communicating, and 
     develop autistic behavior. Other parents have testified that 
     their children never start to develop language skills, and 
     instead early on manifest symptoms of autism. I can only 
     imagine how frustrating and difficult this must be for 
     families. And I appreciate how urgently we need to understand 
     what causes autism, how to treat it, and if possible, how to 
     prevent it.''
       A summary of the developing theories on the causes of 
     autism, as described in ``Autism & Vaccines: A New Look At An 
     Old Story'' by Barbara Loe Fisher is paraphrased below:
       In 1943, when child psychiatrist Leo Kanner first described 
     11 cases of a new mental illness in children he said was 
     distinguished by self-absorbed detachment from other people 
     and repetitive and bizarre behavior, he used the word 
     ``autistic'' (from the Greek word auto, meaning ``self.'') 
     Pointing out similarities with some behaviors exhibited by 
     adult schizophrenics, Kanner and other psychiatrists assumed 
     autistic children were exhibiting early-onset adult-type 
     psychoses. Kanner's young patients came from well-educated 
     middle and upper class families in Baltimore with mothers and 
     fathers who were doctors, lawyers and professors. In 1954, 
     Kanner said, ``We have not encountered any one autistic child 
     who came of unintelligent parents.'' This concentration of 
     autistic children in educated and professionally successful 
     families led Kanner to develop the ``refrigerator Mom'' 
     theory as the cause of autism, theorizing that the warm 
     maternal instincts of educated working mothers was absent or 
     diminished. Influenced by Kanner, pediatricians for decades 
     were persuaded to blame mothers of autistic children for 
     being cold and emotionally rejecting, causing the children in 
     turn to coldly reject contact with other people.
       By 1954, Kanner began modifying his ``Blame the Mother'' 
     position in light of evidence that brothers and sisters of 
     autistic children were often well-adjusted, high functioning 
     children. These findings suggested that the development of 
     autism was also a result of genetic or ``constitutional 
     inadequacies'' as well as bad parenting. In 1971, Kanner 
     admitted that Mothers were not to blame. However, 
     psychoanalyst Bruno Bettleheim continued purporting the 
     ``rejecting parent'' theme. Bettleheim, a holocaust death-
     camp survivor, insisted that the autistic child was behaving 
     in abnormal ways in retaliation against a rejecting mother 
     who had traumatized the child by failing to provide enough 
     love or attention.
       However, a California psychologist and father of an 
     autistic child, Bernard Rimland, Ph.D., in 1964 disproved Dr. 
     Bettleheim's theories through the publication of his landmark 
     book Infantile Autism: The Syndrome and Its Implications for 
     a Neural Theory of Behavior. In this book, Dr. Rimland 
     methodically dismantled the psychoanalytic theory of autism 
     and argued for a biological, specifically a neurological, 
     basis for autistic behavior. Dr. Rimland documented the 
     similarities between brain injured children and autistic 
     children, liberating parents from the destructive guilt 
     associated with having an autistic child and pointing autism 
     research in the direction of investigating the biological 
     mechanisms underlying the brain and immune dysfunction 
     symptoms and their possible causes.
       In 1965, Dr. Rimland established the Autism Society of 
     America (ASA). In 1967 he established the Autism Research 
     Institute (ARI) and began distributing a questionnaire to 
     parents of autistic children. Some 36 years later, his 
     databank includes information on more than 30,000 cases of 
     autism from around the world. In analyzing the data for age 
     of onset of autism, he discovered that before the early 
     1980's, most of the parents reported their children first 
     showed signs of abnormal behavior from birth or in the first 
     year of life. But after the mid-1980's, there was a reversal 
     of this pattern. The numbers of parents reporting that their 
     children developed normally in the first year and a half of 
     life and then suddenly became autistic doubled. Today, 
     Rimland says that the onset-at-18-months children outnumber 
     the onset-at-birth children by 2 to 1.
       Today, no one can pinpoint the exact cause or causes of 
     autism. Nor is there any conclusive explanation for the rapid 
     growth in cases of late-onset autism. Most experts believe 
     that some combination of genetic and environmental factors 
     must be at work. A leading and prominent theory is that the 
     growing amount of mercury in childhood vaccines may have 
     triggered an autistic response in children who are 
     genetically predisposed to being vulnerable to mercury 
     damage.

  B. The alarming growth in autism coincided with an increase in the 
 number of childhood vaccines containing thimerosal on the recommended 
                                schedule

       Through most of the twentieth century, individuals were 
     required to receive very few vaccines. However, with the 
     licensing of the Hepatitis B (Hep B) vaccine and the 
     Haemophilus Influenzae Type b (Hib) vaccine starting in the 
     mid-to-late 1980's, and their subsequent recommendation for 
     universal use in 1991, the amount of mercury to which infants 
     were exposed rose dramatically. It was during this period of 
     increased exposure to thimerosal and its ethylmercury 
     component that the growing wave of late-onset autism became 
     apparent. This confluence of events led many to suspect a 
     correlation between the two and call for more research into 
     the relationship between ethylmercury in vaccines and autism 
     spectrum disorders.
       A number of vaccines never contained thimerosal. These 
     classes of vaccines are generally live-virus vaccines. The 
     ethylmercury in thimerosal would kill the living virus, 
     making it unsuitable for such vaccines. These shots include 
     the Measles-Mumps-Rubella (MMR) vaccine, the oral polio 
     vaccines (which are no longer recommended for use in the 
     United States), and the chicken pox (varicella zoster) 
     vaccines.
       Prior to the approval of the recombinant Hepatitis B 
     vaccine in 1986, the only vaccine containing thimerosal 
     routinely given to infants was the DTP vaccine. DTP contained 
     25 micrograms of ethylmercury and was given 3 times in the 
     first six months of life (75 micrograms of ethylmercury) and 
     a total of four times in two years (100 micrograms of 
     ethylmercury).
       The polysaccaride Haemophulus Influenzae B (Hib) vaccine 
     was first licensed in 1985. It had 25 micrograms of 
     ethylmercury and was given 3 times in the first six months of 
     life (75 micrograms of ethylmercury) and a total of four 
     times in the first two years of life.
       The approval of the Hep B vaccine in 1986 added another 
     thimerosal-containing shot to the recommended schedule. This 
     vaccine contained 12.5 micrograms of ethylmercury and was 
     given within hours of birth and a total of 3 times in the 
     first six months of life (37.5 micrograms of ethylmercury).
       After 1986, some children went from getting 25 micrograms 
     in one day or 75 micrograms in the first six months of life 
     to getting 62.5 micrograms of ethylmercury in a day or 187.5 
     micrograms in the first six months of life. This would be in 
     addition to any fetal exposure to mercury from the mother. In 
     1991, the CDC recommended that both Hib and Hep B be added to 
     the universal recommendations for childhood immunization.
       As was noted previously, the effects of ethylmercury have 
     not been studied as carefully as methylmercury, and the 
     Federal Government has not established safety thresholds for 
     ethylmercury exposure. Because of the obvious similarities 
     between the two, however, when the FDA reviewed the amount of 
     injected ethylmercury in vaccines in 1999, they compared it 
     to the Federal limits for (ingested) methylmercury exposure. 
     They were compelled to admit at that point that the 
     cumulative amount of ethylmercury in vaccines exceeded the 
     EPA's threshold for exposure to methylmercury. This led the 
     FDA to recommend the removal of thimerosal from most 
     pediatric vaccines in 1999, more than a decade after the 
     Hepatitis B vaccine was added to the schedule.
       In point of fact, the potential problem was worse than the 
     FDA suggested. Not only did the cumulative amount of 
     ethylmercury on the routine schedule exceed the EPA's limit, 
     the amount of ethylmercury in each individual shot of DTP (or 
     DTaP) and Hepatitis B exceeded the limit. Young children were 
     getting three boosters of each shot. The EPA's threshold is 
     0.1 micrograms of methylmercury for each kilogram of body 
     weight. This does not mean that injury would definitely occur 
     above this level because a significant safety margin is built 
     in. However, the chances of injury increase as the exposure 
     rises above this level. For an 11-pound baby (five 
     kilograms), the threshold would be roughly 0.5 micrograms. 
     For a 22-pound baby (ten kilograms), the threshold would be 1 
     microgram. The DTP (and DTaP) vaccine contained 25 micrograms 
     of thimerosal per dose, as does the Hepatitis B vaccine. The 
     Hib vaccine contained 12.5 micrograms per dose. In addition, 
     it is clear that for many, many children, the amount of 
     thimerosal they received in vaccines in the 1990's also 
     exceeded the FDA's higher threshold of 0.4 micrograms per 
     kilogram of body weight.
       Of particular concern to many parents are those instances 
     in which children received several vaccines in one visit to 
     their pediatrician. This practice has become commonplace with 
     the new vaccine schedules recommending 26 doses of vaccines 
     before school attendance.
       Chairman Burton spoke about one such incident at a recent 
     hearing: ``The FDA recently acknowledged that in the first 6 
     months of life children get more mercury than is considered 
     safe by the EPA. The

[[Page 12728]]

     truth is that sometimes kids go to their doctor's office and 
     get four or five vaccines at the same time. My grandson 
     received vaccines for nine different diseases in 1 day. He 
     may have been exposed to 62.5 micrograms of mercury in 1 day 
     through his vaccines. According to his weight, the maximum 
     safe level of mercury he should have been exposed to in 1 day 
     is 1.5 micrograms, so that is 41 times the amount at which 
     harm can be caused.
       When testifying before the Committee, Mrs. Lynn Redwood 
     made the following observation regarding her son's bolus 
     exposure to mercury through vaccinations: ``According to the 
     EPA criteria, his allowable dose was only 0.5 micrograms 
     based on his weight. He had received 125 times his allowable 
     exposure on that day. The large injected bolus exposures 
     continued at two months, four months, 12 months, and 18 
     months to a total mercury exposure of 237.5 micrograms. I 
     also discovered that the injections that I received during my 
     pregnancy, the first and third trimesters, and hours after 
     the delivery of my son to prevent RH blood incompatibility 
     disease also contained mercury.''
       Concern that autism may be linked to vaccines is not a new 
     debate. Twelve years ago, the Institute of Medicine was asked 
     to evaluate the science on a possible connection. The 
     Institute of Medicine published Adverse Effects of Pertussis 
     and Rubella Vaccines and confirmed that pertussis and rubella 
     vaccines can cause brain and immune system damage. At the 
     time, an increasing number of parents reported that their 
     previously normal children were regressing into autism after 
     DTP or MMR vaccination. However, the IOM physician committee 
     charged with analyzing the medical literature for evidence of 
     cause and effect, rejected the reported link between 
     pertussis vaccine and autism, because `no data were 
     identified [in the medical literature] that address the 
     question of a relation between vaccination with DTP or its 
     pertussis component and autism.'
       Dr. Stephanie Cave, who provided testimony to the 
     Committee, is a doctor in Baton Rouge, Louisiana whose 
     medical practice is focused on treating children with the 
     symptoms of autism. She concurs with other experts from whom 
     the Committee received testimony that there appears to be a 
     correlation between increased use of vaccines containing 
     thimerosal and a rise in autism:
       ``I believe that the introduction of the hepatitis B 
     vaccine in 1991 has sparked this recent epidemic because of 
     thimerosal. When added to the mercury imparted through the 
     DTP and HIB, the exposure to mercury exceeds EPA safe limits 
     for the metal if you consider a bolus dose on a single day.
       ``The EPA limits are usually related to ingested mercury, 
     which is partially cleared by the liver. Injecting boluses of 
     ethylmercury presents an entirely different, another 
     scenario. The 2-month dose of mercury is at least 30 times 
     higher than the recommended daily maximum exposure set by the 
     EPA. During the 1990's, infants received 12.5 micrograms of 
     mercury at birth, followed by 12.5 micrograms at 1 month, 
     62.5 micrograms at 2 months, 50 micrograms at 4 months, 50 
     micrograms at 6 months, 50 micrograms at 15 to 18 months; a 
     total of 237.5 micrograms for a child who at best weighs 10 
     kilograms. This far exceeds the safety limits if you consider 
     bolus dosing. Safety limits would be more like 1 to 1.5 
     micrograms.
       ``The bile production is minimal in infancy, making it more 
     difficult for metals to be cleared from the body. When added 
     to a vaccine, the metals are even more dangerous because the 
     vaccines trigger immune reactions that increase the 
     permeability of the GI tract and the blood/brain barrier.
       ``The injection of mercury appears to affect only certain 
     children, but I fear that we've underestimated the 
     devastation by concentrating only on the autistic children. 
     We're measuring elevated levels of mercury in other children 
     with milder difficulties like learning disabilities, ADHD, 
     Asperger's Syndrome and many others. We do not have any idea 
     what the scope of this problem is at this point. And there 
     are no safety standards for infants getting bolus doses of 
     ethyl-
     mercury.''


  v. valid concerns about mercury in vaccines were ignored by federal 
           policymakers and vaccine manufacturers for decades

       As early as 1931, scientists were noting adverse reactions 
     to thimerosal. In fact, Dr. Kharasch filed a new patent 
     application because he reformulated the product to 
     ``stabilize merthiolate due to its tendency to acquire 
     `certain burning qualities'.''
       In 1932, in a paper published by Lilly researchers who 
     found Merthiolate to be a skin-disinfecting agent, it was 
     noted that another researcher has seen adverse reactions. 
     ``Reimann has reported that some individuals display a 
     sensitiveness to thio [thimerosal] compounds, which is 
     characterized by reddening of the treated area and the 
     appearance of small papules and vesicles.''
       In 1935, in a letter from the Director of Biological 
     Services, of the Pittman-Moore Company to Dr. Jamieson of Eli 
     Lilly, ``we have obtained marked local reaction in about 50 
     percent of the dogs injected with serum containing dilutions 
     of Merthiolate varying from 1 in 40,000 to 1 in 5,000 . . . 
     no connection between the lot of serum and the reaction. In 
     other words, Merthiolate is unsatisfactory as a preservative 
     for serum intended for use on dogs . . . . I might say that 
     we have tested Merthiolate on humans and find that it gives a 
     more marked local reaction than does phenol and tricresol.''
       In 1942, an Army doctor in Baltimore, Maryland published a 
     journal paper in which he raised concerns about thimerosal: 
     ``Some investigators claim that if a patient's skin is 
     sensitive to one of the mercurials he may be sensitive to any 
     compound containing mercury. We have investigated 5 patients 
     with dermatitis due to Merthiolate and found that four were 
     sensitive to Merthiolate and not to any other organic or 
     inorganic mercury compounds with which they were tested . . . 
     . Sulzberger found that in performing routine patch tests 
     with 10 percent ammoniated mercury ointment and 10 percent 
     salicylic acid ointment he obtained relatively few positive 
     reactions; but if the two ointments were combined so that the 
     concentration was five percent of each, then 50 percent of 
     all patients tested gave positive reactions.'' Dr. Elliss 
     further explained in his paper, ``Dr. J. H. Mitchell in a 
     lecture before the American Academy of Dermatology in New 
     York in December 1941, stated that he had observed a number 
     of cases of severe dermatitis following the treatment of 
     dermatophytosis with preparations of Merthiolate.''
       In 1943, Dr. Elliss published a case report in the Archives 
     of Opthalmology, which states:
       ``The positive results of patch tests demonstrated that the 
     two patients were sensitive to tincture of merthiolate were 
     also sensitive to 1:5000 merthiolate ophthalmic ointment and 
     that merthiolate is capable of causing an inflammation of the 
     mucous membrane in patients who are sensitive to the drug. In 
     view of these facts it is recommended: 1. That Merthiolate 
     ophthalmic ointment should not be used in or about the eye 
     unless it has been previously demonstrated by patch tests 
     that the patient is not sensitive to the ointment. 2. That 
     the package should be labeled to warn the consumer that such 
     tests should be made previous to the use of merthiolate 
     ophthalmic ointment in or about the eye. Since a patient may 
     become sensitized to Merthiolate while using the ophthalmic 
     ointment, it may be advisable to withdraw this product from 
     the market before a case of permanent ocular damage occurs, 
     in spite of the fact that no cases of ocular injury due to 
     merthiolate have been reported.''
       Taken from an October 1978, letter from William R. Gibson 
     to Dr. Alan Baskett, of the Commonwealth Laboratories in 
     Victoria, Australia regarding a concern that thimerosal in 
     the Australian pertussis vaccine was linked to 
     intersucception in mice:
       ``I discussed the possible effect of ethylmercury with 
     Bordetella pertussis to supplement B-adrenergic blockade. 
     Again, it was not believed that this blockade should 
     predispose toward intessusception, although it was recognized 
     that increased motility resulted and that this could be 
     causative. As with other chemicals of its generation, data 
     relating to its safety and pharmacological effects in animal 
     models are sparse.''
       In August of 1998, an FDA internal ``Point Paper'' was 
     prepared for the Maternal Immunization Working Group. This 
     document, prepared almost a full year before the Public 
     Health Service--American Academy of Pediatrics joint 
     statement made the following recommendation:
       ``For investigational vaccines indicated for maternal 
     immunization, the use of single dose vials should be required 
     to avoid the need of preservative in multi-dose vials . . . . 
     Of concern here is the potential neurotoxic effect of mercury 
     especially when considering cumulative doses of this 
     component in early infancy . . . .''
       On September 8, 1998, the Safety Working Party of the 
     European Agency for the Evaluation of Medicinal Products 
     issued its working paper, ``Assessment of the Toxicity of 
     Thimerosal in Relation to Its Use in Medicinal Products.'' 
     The Working Party concluded:
       ``There is ample evidence from the literature that 
     thiomersal (thimerosal) may cause sensitization and 
     subsequent allergic reactions . . . the use of thimerosal is 
     vaccines given to infants in accordance with various national 
     vaccine programs may in certain cases result in approximately 
     two times higher intake of ethylmercury during the first year 
     of life than what can be considered reasonably safe. Given 
     the great uncertainty of the estimations of safe levels in 
     young children, it is suggested to restrict the use of 
     thimerosal in vaccines.''
       In June of 2000, the CDC convened a closed meeting to 
     discuss research evidence that showed a connection between 
     thimerosal in vaccines and neurological injury. Dr. Thomas 
     Verstraeten, a CDC employee who has since left the agency to 
     work in Belgium for a vaccine manufacturer, utilized the 
     Vaccine Safety Datalink to evaluate any possible connection 
     between thimerosal-preserved vaccines and neurological or 
     renal impairment. He found, ``a statistically significant 
     positive correlation between the cumulative exposure at 2 
     months and unspecified developmental delay; the cumulative 
     exposure at 3 months and tics; the cumulative exposure at 6 
     months and attention deficit disorder . . . 1, 3 and 6 months 
     and language and

[[Page 12729]]

     speech delay . . . 1, 3, and 6 months of age and 
     neurodevelopmental delays in general.''
       He concludes:
       ``This analysis suggests that in our study population, the 
     risks of tics, ADD, language and speech delays, and 
     developmental delays in general may be increased by exposures 
     to mercury from thimerosal-containing vaccines during the 
     first six months of life.''
       This issue will be discussed in more detail in another 
     section of this report.
       The Committee and the public have been frustrated by the 
     Department of Health and Human Services reluctance to accept 
     that all forms of mercury are toxic and that children have 
     likely been harmed from the FDA's negligence in assuring the 
     safety of thimerosal and in not monitoring the increased 
     exposure to mercury through vaccines.
       During the July of 2000 hearing on mercury, Congresswoman 
     Helen Chenoweth-Hage (R-ID) eloquently expressed the views of 
     many.
       Mrs. Chenoweth-Hage:
       ``. . . I have a staffer who is in the Navy Reserve right 
     now, but he used to be active with the airborne divisions, 
     and he was in for a test in one of the medical military 
     hospitals, and upon taking his temperature, they broke a 
     thermometer, and mercury splattered across his glasses and 
     some got in his eye. Well, the first thing they did was 
     cutoff his clothes. The second thing was call in OSHA to 
     clean up the mercury. And then they worked on him to make 
     sure his eyes were irrigated, and you guys, you witnesses, 
     absolutely amaze me. I wonder where the disconnect is, for 
     Pete's sake.
       ``You listened to the testimony just as I did, and you are 
     willing to, with a straight face, tell us that you are 
     eventually going to phase this out after we know that a small 
     baby's body is slammed with 62 times the amount of mercury 
     that it is supposed to have, and OSHA reacts like they did in 
     the case of this accident of this naval man. It doesn't make 
     sense. No wonder people are losing faith in their government. 
     And to have one of the witnesses tell us it is because 
     mothers eat too much fish? Come on. We expect you to get 
     real. We heard devastating testimony in this hearing today, 
     and we heard it last April. And this is the kind of response 
     we get from our government agencies?
       I am sorry. When I was a little girl, my daddy talked to me 
     about something about a duck test. I would ask each one of 
     you to read this very excellent work by Sallie Bernard and 
     Albert Enayati, who testified here today. My daddy used to 
     say if it walks like a duck and talks like a duck and sounds 
     like a duck, for Pete's sake it is a duck.
       ``I recommend that you read this, side-by-side, page after 
     page of analysis of the symptoms of people who are affected 
     with mercury poisoning compared to autism, this is the duck 
     test, and you folks are trying to tell us that you can't take 
     this off the market when 8,000 children are going to be 
     injected tomorrow; 80 children may be coming down, beginning 
     tomorrow, with autism? What if there was an E. coli scare? 
     What if there was a problem with an automobile? The recall 
     would be like that.
       ``We are asking you to do more than analyze it. We are 
     asking you to tell this body and the American people that it 
     is more inconclusive. It passes the duck test, and we need 
     you to respond. We need that to come off the market now 
     because you think that this is--do you think that we are 
     elevating the case today? Just wait until it gets in the 
     courts. This case could dwarf the tobacco case. And we would 
     expect you to do something now before that circus starts 
     taking place. Denial is not proper right now.
       ``You know, I still go back to the fact--I still want to 
     talk about the duck test. Mr. Egan, [FDA] I will address this 
     to you. You know, it was shown in the last panel that 
     autistic symptoms emerge after vaccination. It was shown that 
     vaccines contain toxic doses of mercury. It was shown that 
     autism and mercury poisoning, the physiological comparison is 
     striking. There is altered neurotransmitter activity, 
     abnormal brain neuronal organization, immune system 
     disturbance, EEG abnormalities. It goes on and on and on, the 
     comparisons. That is why I say, I back up what the Chairman 
     and the ranking member are all asking you, that we cannot 
     wait until 2001 to have this pulled off.
       ``You know, if a jury were to look at this, the 
     circumstantial evidence would be overwhelming. Let's do 
     something before we see it in the courts.''
       In 2003, thimerosal remains in some vaccines.

A. Many parents of autistic children believe that adverse reactions to 
        vaccines are responsible for their children's condition

       Based on their personal experiences, many parents believe 
     that the autistic condition of their children is related to 
     an adverse reaction to a childhood vaccine, or a series of 
     vaccinations. This is particularly true of parents of 
     children who have developed ``late onset autism,'' in which 
     symptoms do not begin to emerge until the child is between 
     one and two years old. This time period coincides with a 
     number of vaccinations on the childhood schedule. While this 
     belief is not universal, many parents hold it passionately.
       Dr. Jeffrey Bradstreet, when testifying before the 
     Committee in 2001, made the following statement:
       ``At a recent autism conference in Chicago, and prior to 
     either my own presentation or that of Dr. Wakefield, I asked 
     the audience of 500 parents if they felt their child 
     regressed following a vaccine. In that obviously non-
     scientific survey, approximately 90 percent the parents 
     raised their hands to affirm vaccines were what they 
     suspected had caused their child's symptoms. When I asked for 
     how many had reported the event under the VAERS system, fewer 
     than 15 said they had. Then I asked if their pediatrician had 
     offered to report this, they just laughed. I have now 
     conducted this simple survey with over 5000 parents at 
     conferences around the world with similar findings. Yes, 
     media attention creates bias. But despite the informal nature 
     of this survey, it does tell us something about this debate 
     we are currently engaged in: (1) parents of children with 
     autism suspect vaccines damaged their child, (2) parents are 
     not reporting this using VAERS forms, (3) pediatricians are 
     not reporting to VAERS either, (4) and despite efforts by 
     policymakers at CDC, FDA, AAP, IOM and elsewhere to reassure 
     parents of the safety of vaccines, they remain unconvinced.''
       The Committee has heard moving testimony from parents in 
     support of this belief, as well as from parent-advocates. 
     Shelley Reynolds is a mother of two from Baton Rouge, 
     Louisiana. When she testified before the Committee in April 
     of 2000, her autistic son, Liam, was four years old. Her 
     testimony left no doubt as to her views:
       ``Liam was a normally developing baby until June 27, 1997, 
     when he received his MMR and Hib vaccines. He did everything 
     he was supposed to do. He cooed, rolled over, crept, crawled, 
     pulled up and walked on time. He said `Mama,' he said 
     `Daddy,' he said `Love you.' He learned how to sing `Itsy 
     Bitsy Spider.' He played finger games with us. He loved to 
     interact, and he especially loved to show off for his 
     grandparents.''

                           *   *   *   *   *

       ``But when he was 17 months old, shortly after he had 
     received the shots, he started exhibiting some different 
     behaviors. He was constantly taking off his shoes; he 
     screamed if we dressed or undressed him; he would stare for 
     hours in front of the television and would not move if you 
     blocked the view. He could not tolerate playing in the 
     sandbox anymore. He did not want to sing any of his favorite 
     songs; he would cover his ears and scream `No.'''

                           *   *   *   *   *

       ``In Liam's case, we have no doubt that he developed his 
     autism as a direct result of an adverse vaccine reaction.''

                           *   *   *   *   *

       ``Many in the medical community continue to dismiss this as 
     mere happenstance because autism often coincides with the 
     time of vaccination, and state that there is no scientific 
     evidence to back this up. My question to you is: How long 
     does it take for a coincidence to surface time and time and 
     time again, case after case after case, before it can become 
     a viable hypothesis, especially when the solution to solving 
     the problem seems so apparent?''
       At the same hearing, the Committee heard testimony from 
     Jeana Smith of Denham Springs, Louisiana. At the time, she 
     was the mother of five-year-old twins, one of whom was 
     autistic. Her testimony made equally clear her conviction 
     that her son's autism was related to a series of vaccinations 
     given on the same day:
       ``Jacob met every developmental milestone that first year, 
     right along with Jesse. They were two little peas in a pod 
     and went everywhere together. At only 16 months of age, Jacob 
     and Jesse received their first MMR vaccine. On this same day, 
     they also received their fourth DTP, their fourth Hib, and 
     their third hepatitis B. The following 24 hours, both twins 
     slept most of the time, with over 100-degree temperatures, in 
     spite of receiving the recommended Tylenol dosage every 6 
     hours. Immediately following that, Jacob began exhibiting 
     strange behaviors. He was no longer excited or responsive 
     when Daddy would come home from work. He began to become 
     preoccupied with certain toys. He would spend long periods of 
     time studying the way their wheels would spin or whether or 
     not they were lined up just right. Any attempt to interrupt 
     or distract him was met with great resistance and an eventual 
     fit. During this time, Jesse continued to progress, starting 
     to talk and interact with all the children around him.''

                           *   *   *   *   *

       ``At times, Jacob was so withdrawn that we could absolutely 
     not reach him.''

                           *   *   *   *   *

       ``For us, there is no denying that in Jacob's case of 
     autism, the answer does not lie in genetics, but in a 
     catalyst. The thousands of hours of research that we have 
     spent searching and retracing his regression continue to 
     point to the fact that the road of Jacob's autism began when 
     his immune system was damaged by the hepatitis B vaccine he 
     received when he was ill. The final blow was the adverse 
     reaction to the host of vaccines he received 16 months later. 
     We are certain that for Jacob, the catalyst was his 
     vaccine.''

[[Page 12730]]

       Testifying two years later, on April 18, 2002, Autism 
     Society of America President Lee Grossman testified about the 
     strongly held views of many of the Society's members:
       ``A substantial number of families within our autism 
     community believe some forms of autism may be caused by some 
     use of vaccines. While we do not know this to be specifically 
     proved at this time, we should not ignore the body of 
     evidence that calls into question the source of many children 
     with autism. If causation is found, those injured must be 
     provided recourse and compensation.''

                           *   *   *   *   *

       ``I think the stories that I have heard that many of our 
     members tell, that many of these people in the audience will 
     tell you, is that they believe that there is evidence that 
     there is a direct linkage, a direct causation of vaccines 
     causing their child's autism. I think it is imperative for 
     us, the advocates in the room, for ASA, and for Congress, for 
     the lay public, to stand together to get this question 
     answered, answered immediately.''

     B. Many parents of autistic children have filed petitions for 
         compensation or lawsuits against vaccine manufacturers

       Not surprisingly, suspicions that there may be a causal 
     relationship between some vaccines and autism have spawned a 
     significant amount of litigation.
       As of October 2002, more than 875 families had filed 
     petitions for compensation under the Federal Vaccine Injury 
     Compensation Program (VICP), alleging that a vaccine or a 
     series of vaccines caused their child's autism. It has been 
     estimated that as many as 3,000 to 5,000 such petitions may 
     be filed in the near future.
       Congress established the VICP in 1987 to provide 
     compensation to families of individuals who suffer vaccine 
     injuries. The Federal government maintains a trust fund out 
     of which awards are paid and which is funded by an excise tax 
     on vaccines. Petitions for compensation are adjudicated 
     before a team of special masters, with the Justice Department 
     representing the Federal government.
       With the knowledge that the growing number of petitions 
     seeking compensation for autism spectrum disorders poses a 
     difficult challenge for the VICP, the Chief Special Master 
     laid out a special two-part procedure for resolving these 
     claims. First, a general causation inquiry known as the 
     ``Omnibus Autism Proceeding'' will be conducted to determine 
     generally if vaccines can cause autism disorders, and if so, 
     under what circumstances. The two-year schedule for 
     completing this omnibus proceeding includes a discovery 
     period for establishing an evidentiary record, testimony of 
     expert witnesses, an evidentiary hearing, and a ruling on 
     general causation issues by July of 2004. In the second part 
     of the two-part procedure, the Special Master's determination 
     in the omnibus proceeding will be applied to individual 
     cases.
       Thus far, there are two primary contentions underlying all 
     of the autism cases filed in the VICP. The first is that the 
     MMR vaccine has caused autism in some children. The second 
     alleges that the mercury contained in several other vaccines 
     caused neurological damage, resulting in autism spectrum 
     disorders. These contentions are summarized in the Master 
     Autism Petition For Vaccine Compensation filed by the 
     families:
       ``As a direct result of one or more vaccinations covered 
     under the National Vaccine Injury Compensation Program, the 
     vaccine in question has developed a neuro-
     developmental disorder, consisting of an `Autism Spectrum 
     Disorder' or a similar disorder. This disorder was caused by 
     a measles-mumps-rubella (MMR) vaccination; by the 
     `thimerosal' ingredient in certain Diptheria-Tetanus-
     Pertussis (DTP), Diphtheria-Tetanus-acellular Pertussis 
     (DTaP), Hepatitis B, and Hemophilus Influenza Type B (HIB) 
     vaccinations; or by some combination of the two [vaccine 
     administrations].''
       In addition to petitions filed under the VICP, many parents 
     have filed lawsuits against vaccine manufacturers and 
     manufacturers of thimerosal. The first such lawsuit was filed 
     in Texas in May of 2001 on behalf of five-year-old Joseph 
     Alexander Counter (Counter v. American Home Products). 
     According to his parents and attorneys, he was diagnosed with 
     autism and then was found to have high levels of mercury 
     exposure. Later that year, a group of law firms calling 
     themselves the ``Mercury Vaccine Alliance'' filed class 
     action lawsuits in nine different states.
       While dozens of lawsuits have been filed, they generally 
     fall into three different categories:
       1. Actions claiming that thimerosal is an adulterant or a 
     contaminant in a vaccine;
       2. Actions seeking compensation for loss of consortium 
     (love and companionship) on behalf of parents of autistic 
     children; and
       3. Class actions seeking compensation for autistic children 
     and medical monitoring for broad populations of children who 
     were exposed to mercury in vaccines.
       Under the National Childhood Vaccine Injury Act, which 
     created the Vaccine Injury Compensation Program, victims of 
     vaccine injuries are not allowed to file lawsuits against 
     vaccine manufacturers unless they have first sought 
     compensation through the VICP. However, one exception allows 
     lawsuits for vaccine injuries allegedly caused by an 
     ``adulterant'' or a ``contaminant'' intentionally added to 
     the vaccine. In twin decisions in May of 2002, a Federal 
     judge ruled that thimerosal could not be considered an 
     adulterant or a contaminant, and claims filed on that basis 
     were dismissed. However, in those same decisions, the court 
     ruled that parents of vaccine-injured children are entitled 
     to seek damages in court for loss of consortium without going 
     through the VICP.
       As these cases work their way through the courts, 
     procedural rulings in different jurisdictions will have a 
     great influence on whether potentially thousands of families 
     seek compensation through the courts or through the VICP.


     VI. A Growing Number of Scientists and Doctors Believe That a 
    Relationship Between Thimerosal in Vaccines and Autism Spectrum 
                         Disorders is Plausible

                            A. Introduction

       A growing number of respected scientists and researchers 
     are convinced that there is a relationship between the use of 
     thimerosal in childhood vaccines and the growing incidence of 
     autism. A number of these scientists have testified before 
     the Committee. At the same time, senior officials from 
     Federal health care agencies and other public health experts 
     continue to insist that there is no evidence of such a 
     relationship.
       Two things appear to be clear in this debate. First, 
     concerns about the use of thimerosal in vaccines existed in 
     public health agencies for more than two decades before 
     action was taken to remove them from vaccines. The lethargic 
     response to these legitimate concerns will be discussed in 
     the following section of this report. Second, much more 
     research needs to be done before any conclusive 
     determinations can be made about vaccines and autism spectrum 
     disorders. Developing more and better research data will be 
     critically important to resolving the legal disputes over 
     compensation for children with autism, and restoring the 
     confidence of the American public in vaccines.
       This section will review the current state of the 
     scientific debate over vaccines and autism.

        B. Institute of Medicine reports call for more research

       In 2001, the Institute of Medicine (IOM) released two 
     reports after reviewing the evidence they received related to 
     possible connections between vaccines and autism. The IOM was 
     created by the National Academy of Sciences in 1970 to 
     conduct independent analyses of public policy matters related 
     to health care. The first report dealt with the MMR vaccine. 
     The second dealt with vaccines containing thimerosal. The 
     common thread linking both reports was the conclusion that 
     much more research needed to be done before firm conclusions 
     could be drawn.
       In April of 2001, the IOM issued its report on the MMR 
     vaccine, entitled, ``Immunization Safety Review--Measles-
     Mumps-Rubella Vaccine and Autism.'' After reviewing the 
     available scientific studies, the IOM determined that: ``The 
     evidence favors rejection of a causal relationship at the 
     population level between MMR vaccine and autism spectrum 
     disorders.''
       The IOM stated that the epidemiological evidence available 
     at the time showed no association at a population level 
     between the MMR vaccine and autism. However, the authors 
     cautioned that if the vaccine triggered autistic disorders 
     among a small number of children who were predisposed to an 
     adverse reaction, the population studies that had been done 
     to-date would be too imprecise to detect them:
       ``It is important to recognize the inherent methodological 
     limitations of such studies in establishing causality. 
     Studies may not have sufficient precision to detect very rare 
     occurrences on a population level. A poor understanding of 
     the risk factors and failure to use a standard case 
     definition may also hamper the ability of epidemiological 
     studies to detect rare adverse events.''
       The IOM recommended further research to determine if 
     exposure to the MMR vaccine is a risk factor for autism 
     disorders in a small number of children. They also called for 
     targeted studies to follow up on a groundbreaking series of 
     case studies by Dr. Andrew Wakefield of Great Britain, who 
     determined that 12 British children who suffered from autism 
     spectrum disorders and chronic bowel inflammation also had 
     vaccine-strain measles virus in their tissues. Although the 
     parents of eight of the twelve children traced the onset of 
     autistic symptoms to the time period when the MMR vaccination 
     was given, the IOM stated that the study was of limited 
     utility because of its small sample size.''
       Six months later, the IOM issued its second report, 
     entitled, ``Immunization Safety Review--Thimerosal-Containing 
     Vaccines and Neurodevelopmental Disorders.'' They found 
     insufficient evidence to accept or reject a connection 
     between thimerosal in vaccines and autism. They did, however, 
     state that such a connection is ``biologically plausible,'' 
     and recommended much more research on the issue.
       The report summarized:
       ``The committee concludes that although the hypothesis that 
     exposure to thimerosal-containing vaccines could be 
     associated with

[[Page 12731]]

     neurodevelopmental disorders is not established and rests on 
     indirect and incomplete information, primarily from analogies 
     with methylmercury and levels of maximum mercury exposure 
     from vaccines given in children, the hypothesis is 
     biologically plausible.''

                           *   *   *   *   *

       ``The committee concludes that the evidence is inadequate 
     to accept or reject a causal relationship between exposure to 
     thimerosal from vaccines and the neurodevelopmental disorders 
     of autism, ADHD, and speech or language delay.''
       The IOM noted that it had reviewed the results of one 
     unpublished epidemiological study that detected a 
     ``statistically significant but weak association'' between 
     exposure to thimerosal-containing vaccines and several types 
     of developmental disorders, including attention deficit 
     disorder, speech and language delay, tics, and general 
     neurodevelopmental delays. Phase I of the study, which was 
     performed with data from the CDC's Vaccine Safety Datalink, 
     (VSD) uncovered the aforementioned associations.
       Phase II of the study, which provided enough data to 
     analyze only speech delays and attention deficit disorder, 
     did not detect an association between those disorders and 
     thimerosal, as had Phase I. After being briefed on both 
     phases of the study, the IOM's Immunization Safety Review 
     Committee agreed that they were inconclusive. The ``VSD 
     Study'' is discussed at greater length in Section VII.
       The IOM also noted with some discomfort that thimerosal had 
     not been removed from all vaccines and medicines given to 
     children and pregnant women. The report specifically cited 
     the influenza vaccine, the diphtheria-tetanus toxoid vaccine, 
     and some nasal sprays. They urged that, ``full consideration 
     be given by appropriate professional societies and government 
     agencies to removing thimerosal from vaccines administered to 
     infants, children or pregnant women in the United States.'' 
     It was also recommended that any remaining stocks of 
     childhood vaccines containing mercury be removed from 
     doctor's offices and replaced with mercury-free alternatives.
       Finally, the report recommended that numerous types of 
     research be conducted to help the scientific community better 
     determine if there is a causal relationship between 
     thimerosal and autism or other disorders. The IOM called for:
       Case-control studies examining the potential link between 
     neurodevelopmental disorders and thimerosal-containing 
     vaccines;
       Further analysis of cohorts of children who did not receive 
     thimerosal-containing doses of vaccines during clinical 
     trials;
       Epidemiological studies comparing the prevalence of 
     neurological disorders in children, who received vaccines 
     before thimerosal was removed, to children who received 
     vaccines after it was removed;
       An increased effort to identify the primary sources and 
     levels of prenatal and postnatal exposure to thimerosal;
       Clinical research on how children metabolize and excrete 
     metals;
       Theoretical modeling of ethylmercury exposures, including 
     the incremental burden of thimerosal on background mercury 
     exposures from other sources;
       Research in appropriate animal models on neurodevelopmental 
     effects of ethylmercury;
       Rigorous scientific investigations of chelation as a 
     treatment for neurodevelopmental disorders; and
       Research to identify a safe, effective and inexpensive 
     alternative to thimerosal for countries that decide they want 
     to follow the example of Europe and the United States and 
     terminate its use in vaccines.

    C. A growing number of researchers believe that there may be a 
      relationship between vaccines and autism spectrum disorders

       A growing number of researchers and medical professionals 
     believe that there may be a link between the mercury 
     preservative used in vaccines and autism spectrum disorders 
     and other neurodevelopmental disorders. Few, if any, would 
     make such a statement categorically until more research is 
     done. However, judging by testimony received by the 
     Committee, many researchers believe that this hypothesis is 
     plausible based on work they have done to-date. They believe 
     that this is a promising field of research that may yield 
     breakthroughs on the question of the underlying causes of the 
     growing incidence of autism and other neurodevelopmental 
     disorders.
       On April 25, 2001, the Committee heard testimony from Dr. 
     Boyd E. Haley, who is the Chairman of the Chemistry 
     Department at the University of Kentucky. Dr. Haley has spent 
     many years studying the effects of mercury on the human body. 
     Dr. Haley summarized his views in this way:
       ``I cannot say, nor would I say, that vaccinations cause 
     autism. However, if the data holds up that I have been seeing 
     with the relationship, I think it is an awfully good suspect, 
     at least one of the co-factors that might aid in the onset of 
     this disease. So I would really recommend and encourage you 
     to put some pressure on the National Institutes of Health 
     (NIH) to look at the contribution of different forms of 
     mercury we put in our medicines and in our dentistry to see 
     what effect they have on the neurological health of 
     Americans.''
       In his testimony, Dr. Haley described his laboratory 
     research on thimerosal:
       ``I was requested to do an evaluation of the potential 
     toxicity of vaccines containing thimerosal as a 
     ``preservative'' versus those vaccines not containing 
     thimerosal. The results were very dramatic as shown in the 
     accompanying Table attached to this document. In our 
     preliminary studies, vaccines containing thimerosal as a 
     preservative consistently demonstrated in-vitro toxicity that 
     was dramatically greater than the non-thimerosal or low-
     thimerosal containing vaccines.''

                           *   *   *   *   *

       ``Our results are very consistent with the reported 
     toxicity of thimerosal-containing vaccines versus non-
     thimerosal containing vaccines as observed in cell culture 
     studies reported in 1986. The chemical rationale for the 
     neurotoxicity of thimerosal is that this compound would 
     release ethyl-mercury as one of its breakdown products. 
     Ethyl-mercury is a well-known neurotoxin. Further, combining 
     thimerosal with millimolar levels of aluminum cation plus 
     significant levels of formaldehyde, also found in these 
     vaccines, would make the vaccine mixture of even greater risk 
     as a neurotoxic mixture.''
       Dr. Haley went on to state that infants are more 
     susceptible to damage from mercury, because the defense 
     mechanisms in their bodies are less well developed:
       ``Infants, with their immature physiology and metabolism, 
     would not be expected to handle mercury as efficiently as 
     mature adults.''

                           *   *   *   *   *

       ``Using this vaccine mixture on infants, who do not have 
     fully developed bilary (liver) and renal (kidney) systems, 
     could dramatically increase the toxic effects, especially if 
     they are spuriously ill. The toxic effects of exposure to 
     thimerosal in infants cannot be reasonably compared to those 
     observed in adults made toxic by exposure to similar ethyl-
     mercury containing compounds. Mercury is primarily removed 
     through the bilary system and aluminum is removed by the 
     renal system. Inability to rid the body of these toxicants 
     would greatly increase the damage they are capable of doing 
     in infants.''
       Dr. Haley's concerns about the inability of infants to fend 
     off the adverse effects of mercury were echoed by Dr. David 
     Baskin. Dr. Baskin is a neurosurgeon and a professor of 
     neurosurgery and anesthesiology at Baylor College of 
     Medicine. He has been involved in extensive research on the 
     central nervous system and serves on scientific advisory 
     boards of the National Institutes of Health. Testifying 
     before the Committee in December of 2002, Dr. Baskin said:
       ``We clearly know infants' brains are more sensitive. We 
     know the blood-brain barrier, the barrier to drugs between 
     the blood and the brain, is virtually gone in infants.''
       Virtually all researchers who have testified before the 
     committee have hypothesized that some children must have a 
     genetic predisposition that makes them more vulnerable to 
     neurological damage from mercury. An exchange between 
     Congressman Burton and Dr. Baskin at the December 10, 2002, 
     hearing reflected this emerging consensus:
       Mr. Burton: ``Do you personally believe from your studies 
     that the mercury is a contributing factor to the cases of 
     autism we have in this country?
       Dr. Baskin: ``Yes.''
       Mr. Burton: ``Do you think it's a large contributing 
     factor, or do you have any percentages? I mean, I know this 
     is a tough question and everything, but you have done a lot 
     of research.''
       Dr. Baskin: ``I think it's hard to look at a percentage. I 
     think that, as NIH is focusing on, there is probably an 
     environment-gene interaction. In other words, a lot of 
     children get the injection and don't become autistic, and so 
     there must be something specific or different about the way a 
     certain subgroup of children are able to handle toxins. . . . 
     I don't think we yet know the answer to that.''
       In his testimony the previous year, Dr. Haley of the 
     University of Kentucky described one possible genetic risk 
     factor. He stated that there is a protein in the brain called 
     APO-E that removes dangerous waste materials from the brain. 
     He added that some individuals are born with a variety of 
     this protein that is very efficient at removing mercury, and 
     some individuals are born with a variety of this protein that 
     is very inefficient at removing mercury:
       ``If you look at the chemistry of the APO-E proteins, this 
     can be reflected in the fact that it is a housekeeping 
     protein that clears the brain of waste materials. If you have 
     APO-E2, you can carry out two atoms of mercury for every atom 
     of APO-E that goes out. If you have APO-E4, you can carry out 
     none.
       ``He [Dr. Mike Godfrey of New Zealand] took this and looked 
     at autistic children. When he did the screen of autistic 
     children, there was a huge preponderance of them that had 
     APO-E4, indicating that there is a genetic risk factor, which 
     deserves further study. And it does imply that the inability 
     to detoxify the cerebral spinal fluid may be at least part of 
     the neurological aspect of this disease.''

[[Page 12732]]

       Dr. Baskin described research he is conducting which 
     demonstrates what the effects of mercury are when it is not 
     removed from brain tissue:
       ``Let me turn to some studies that we're doing at Baylor 
     College of Medicine. We have the opportunity to actually grow 
     human frontal cortex cells in cell culture. So these are 
     cells from the front part of the brain that grow in culture. 
     We incubate these cells with thimerosal at various doses, and 
     we use a number of very sophisticated techniques to detect 
     cell death and cell damage.''

                           *   *   *   *   *

       ``Here are some pictures from our cell culture experience, 
     and you can see the arrows pointing to those little knobs 
     sticking off the cell. These are the cells committing the 
     suicide program and breaking themselves into tiny little 
     pieces with a very low dose of mercury.''
       ``Here is a slide where you see a lot of blue cells. This 
     is a blue dye that normal cells don't take up. In order for 
     something to turn blue, the cell has to have holes punched in 
     their membranes. And guess what: At an extraordinarily low 
     dose of thimerosal, most of the cells are blue. It means that 
     this stuff grabs a hold of the membrane and punches holes 
     into it, so that the dye can penetrate, not only into the 
     cytoplasm but into the very center of the cell, the nucleus, 
     where all the DNA exists.''

                           *   *   *   *   *

       ``Don't forget, we did this in adult brain cells. Remember 
     that infant brain cells are much more sensitive, so there's a 
     real cause for concern.''
       Dr. Baskin testified that other researchers in his field 
     are finding similar results:
       ``At the recent International Meeting for Autism Research 
     at the Society for Neuroscience, a number of investigators 
     around the world are finding similar things. At Columbia 
     University, there's now a model in mice who were injected 
     with low doses of thimerosal very similar to what's given in 
     human vaccines. These mice develop neurological deficits that 
     look like autism, and when you take their brains out and you 
     analyze them, they have the same type of brain damage.''

D. Public health officials continue to defend the use of thimerosal in 
                                vaccines

       Public health officials continue to resist the idea that 
     thimerosal may have contributed to the growth in autism 
     spectrum disorders. In public statements as recently as 
     December of 2002, Federal officials have continued to defend 
     the use of thimerosal, despite the fact that:
       They asked vaccine manufacturers to remove thimerosal from 
     childhood vaccines more than three years ago;
       In the 1990's, they acknowledged that many children 
     received a cumulative amount of ethylmercury in vaccines that 
     exceeded the EPA's safe limits for methylmercury;
       One Federally sponsored study showed an association between 
     thimerosal in vaccines and some developmental disorders.
       On April 18, 2002, the Committee heard testimony from 
     Melinda Wharton, Director of the Epidemiology and 
     Surveillance Division of the CDC's National Immunization 
     Program. Her response to a question about mercury in vaccines 
     hinted at the skeptical attitude that prevails at the CDC and 
     the FDA:
       ``As far as the thimerosal issue is concerned, the evidence 
     is too incomplete and fragmentary to make any decisions about 
     causation. Of course, many substances are known to be 
     dangerous when administered in high concentrations, but the 
     additives that are included in vaccines are present in trace 
     amounts, and even when multiple vaccines are given, these are 
     still very small amounts of products. It is not established 
     even that thimerosal is associated with any harm as a vaccine 
     additive.
       ``That said, we have committed a large amount of staff time 
     and funding to try to further elaborate these issues and have 
     designed a whole series of studies that have been described 
     in our written testimony that we believe will help address 
     these issues.''
       She further stated:
       ``There are not data to--there are no established harms 
     associated with this. I know this is a subject of great 
     concern, and a number of studies are underway, but we do not 
     have data that support known hazards associated with 
     thimerosal contained in vaccines at this point.''
       Later in 2002, Dr. Karen Midthun, Director of the FDA's 
     Office of Vaccines Research and Review, expressed almost 
     identical views:
       ``Our review showed no evidence of harm caused by 
     thimerosal used as a preservative in vaccines except for 
     local hypersensitivity reactions.''

                           *   *   *   *   *

       ``To date, the existing data do not demonstrate a causal 
     relationship between vaccines and autism. Nonetheless, I want 
     to assure this committee, the public, and especially parents, 
     that the FDA continues to take these issues seriously.''
       In her testimony, Dr. Midthun attempted to downplay the 
     extent to which the exposure to ethylmercury from vaccines in 
     the 1990s exceeded the EPA's threshold for methylmercury 
     exposure:
       ``During the first 6 months of life, cumulative exposure to 
     mercury could have exceeded the more conservative limits of 
     the EPA in some cases, depending on the specific vaccine 
     formulations used and the weight of the infant.''
       There is no question that the cumulative amount of 
     ethylmercury on the recommended schedule of childhood 
     vaccinations exceeded the EPA's threshold for methylmercury. 
     In fact, there is little doubt that the amount of 
     ethylmercury in individual vaccines exceeded the threshold. 
     The EPA's threshold is 0.1 micrograms per kilogram of body 
     weight. For an eleven-pound baby, the EPA's safe threshold 
     would be 0.5 micrograms. Although thimerosal has been removed 
     from these vaccines today in the United States, in the 
     1990's, Aventis Pasteur's DTaP vaccine contained 25 
     micrograms of thimerosal. Glaxo-
     SmithKline's Hepatitis B vaccine contained 12.5 micrograms of 
     thimerosal. Wyeth Lederle's Hib vaccine contained 25 
     micrograms of thimerosal.
       Dr. Midthun's carefully couched statement suggested that 
     there were many instances in which U.S. infants were exposed 
     to cumulative levels of ethylmercury from their vaccines that 
     were significantly lower than the EPA threshold for 
     methylmercury. In the 1990's, at least, this does not appear 
     to have been the case. It is clear that the DTaP, Hepatitis B 
     and Hib vaccines exceeded the EPA's threshold individually 
     for almost all infants, without even considering cumulative 
     amounts. In fact, as will be discussed in the next section of 
     this report, the amount of ethylmercury in these vaccines 
     also exceeded the FDA's higher threshold of 0.4 micrograms 
     per kilogram for most babies.
       One vaccine policymaker, who was at least partially swayed 
     by the Faroe Islands studies and other evidence, was Dr. Neal 
     Halsey, Director of the Institute of Vaccine Safety at Johns 
     Hopkins University. Dr. Halsey was an influential member of 
     Federal advisory committees that oversaw the expansion of the 
     Federally recommended schedule of childhood vaccines in the 
     1990s. By all accounts, Dr. Halsey was instrumental in the 
     decision to seek the removal of Thimerosal from childhood 
     vaccines in 1999.
       In contrast to Dr. Midthun's statements, Dr. Halsey told 
     the New York Times that he was astonished when he reviewed an 
     FDA analysis of how much mercury was in vaccines being given 
     to children:
       ``My first reaction was simply disbelief, which was the 
     reaction of almost everybody involved in vaccines. In most 
     vaccine containers, thimerosal is listed as a mercury 
     derivative, a hundredth of a percent. And what I believed, 
     and what everybody else believed, was that it was truly a 
     trace, a biologically-insignificant amount. My honest belief 
     is that if the labels had had the mercury content in 
     micrograms, this would have been uncovered years ago. But the 
     fact is, no one did the calculation.''
       ``My first concern was that it would harm the credibility 
     of the immunization program. But gradually it came home to me 
     that maybe there was some real risk to the children.''
       In a statement released by Johns Hopkins University after 
     the publication of the profile in the New York Times, Dr. 
     Halsey clarified that he still does not believe that there is 
     a connection between thimerosal and autism:
       ``Neal Halsey, MD, . . . does not and has not supported the 
     belief that thimerosal or vaccines themselves cause autism in 
     children, saying scientific evidence does not suggest any 
     causal association between any vaccine and autism.''
       However, Dr. Halsey's statement made it equally clear that 
     he believes that there may be an association between 
     exposures to low levels of mercury and other neurological 
     impairments. His statement referred specifically to the Faroe 
     Islands studies and the calculation that the cumulative 
     amount of thimerosal in childhood vaccines exceeded the EPA's 
     limits for methylmercury:
       ``In 1999, Dr. Halsey became concerned that the use of 
     thimerosal as a preservative in many vaccines led to some 
     children being exposed to more ethylmercury than was 
     recommended, based on guidelines from the Environmental 
     Protection Agency for exposure to methylmercury, a related 
     product. Recent studies have determined that children who as 
     fetuses were exposed to low to moderate amounts of 
     methylmercury through fish consumed by their mothers were at 
     an increased risk for having mild neurological learning 
     deficiencies. The findings from the studies did not show an 
     association between methylmercury exposure and autism.''

                           *   *   *   *   *

       ``As a precaution and in an effort to make vaccines as safe 
     as possible, Dr. Halsey worked with the American Academy of 
     Pediatrics and the Public Health Service in 1999 to urge 
     reductions in exposure to mercury, in all its forms, for 
     infants and children, and to discontinue using thimerosal as 
     a preservative whenever possible.''

 E. Research on the effects of thimerosal has been too limited to draw 
                              conclusions

       To date, very little epidemiological or clinical research 
     has been done on the neurological effects of thimerosal, and 
     particularly its ethyl-mercury component. As the IOM noted in 
     its report on thimerosal, ``the

[[Page 12733]]

     data regarding toxicity of low doses of thimerosal and 
     ethylmercury are very limited,'' and most of the conclusions 
     that have been drawn about ethylmercury are based on 
     analogies to methylmercury, which has been more widely 
     studied. The few studies that have been performed on 
     ethylmercury have been of limited value, for several reasons.
       Perhaps Dr. Thomas Verstraeten conducted the broadest 
     review of a possible relationship between thimerosal and 
     neurological disorders in 2000. This study reviewed several 
     years of medical records from the Vaccine Safety Datalink 
     maintained by the CDC. As noted earlier, Phase I of this 
     study purported to find a statistically significant 
     association between exposure to thimerosal and some 
     neurological disorders. However, this study has never been 
     published. Moreover, because the data used in the study comes 
     from the Vaccine Safety Datalink, and because the medical 
     records in this database are jealously guarded by the CDC, 
     the data used in this study has never been made public. It is 
     discussed at greater length in the next section of this 
     report.
       In November of 2002, a study on thimerosal conducted at the 
     University of Rochester was published in The Lancet, Great 
     Britain's premiere medical journal. The authors studied 40 
     children who were given vaccines containing thimerosal, and 
     21 children who were given vaccines without thimerosal. 
     Samples of blood, stools and urine were obtained from 3 to 28 
     days after vaccination to determine how much mercury remained 
     in the blood and how much was expelled in the urine and in 
     stools.
       The authors found low levels of mercury in the blood of 
     infants exposed to thimerosal, and high levels of mercury in 
     their stools, indicating to them that ethylmercury has a 
     shorter half life then methylmercury, and that most of the 
     mercury was excreted through the gastro-intestinal tract. 
     According to the authors:
       ``We have shown that very low concentrations of blood 
     mercury can be detected in infants aged 2-6 months who have 
     been given vaccines containing thiomersal [sic]. However, no 
     children had a concentration of blood mercury exceeding 29 . 
     . . parts per billion, which is the concentration thought to 
     be safe in cord blood.''
       The authors went on to conclude:
       ``Overall, the results of this study show that amounts of 
     mercury in the blood of infants receiving vaccines formulated 
     with thiomersal [sic] are well below concentrations 
     potentially associated with toxic effects. Coupled with 60 
     years of experience with administration of thiomersal-
     containing vaccines, we conclude that the thiomersal in 
     routine vaccines poses very little risk to full-term infants, 
     but that thiomersal-containing vaccines should not be 
     administered at birth to very low birth weight, premature 
     infants.''
       Skeptics of a vaccine-autism connection hailed this study. 
     However, its value is limited by a number of criticisms that 
     have been raised since its publication. Some of the most 
     commonly cited shortcomings were discussed in testimony at 
     the Committee's December 10, 2002, hearing by Baylor 
     University's Dr. Baskin.
       1. The sample size was very small:
       Only 40 children who received thimerosal were studied. If a 
     small number of children were genetically predisposed to 
     injury by mercury, the chances of a sample of 40 children 
     detecting such a trend would be very low. In his testimony, 
     Dr. Baskin stated:
       ``The sample size, as you said, Dr. Weldon, was small. 
     Autism occurs in one in 150 kids. So if a child had some 
     different tendency in their blood to absorb more mercury or 
     have it remain in the blood longer or be more sensitive in 
     their brain, if they only checked 40 kids, they may well not 
     have found even one kid with a predisposition to autism.''
       2. The sample was not random:
       In his testimony, Dr. Baskin commented on the importance of 
     a random sample size:
       ``The sample wasn't random. They didn't take kids from 
     different portions of the population in different areas. If 
     there's some metabolic difference based on race or sex or 
     where you live or other things, they wouldn't have found 
     it.''
       3. Blood samples were drawn too late to detect peak levels 
     of mercury:
       In an effort to determine how long it takes ethylmercury to 
     be expelled from an infant's body, and what the expected 
     half-life of injected ethylmercury is, the authors drew blood 
     from their subjects at varying times between three and 28 
     days after shots were administered. However, as Dr. Baskin 
     notes, peak levels of mercury in the blood are expected to 
     appear within 24 hours:
       ``We know the stool levels were high, but if you look at 
     when they actually measured the blood levels, they said it 
     was somewhere between 3 and 27 days later. The peak mercury 
     levels after injection occur within hours or at least within 
     the first 24 hours. So if they were drawing blood later than 
     that, and much later than that, of course the levels weren't 
     going to be high. But the mercury doesn't jump from the 
     injection to the stool; it goes through the blood. At some 
     point it was high because it was high in the stool.''

                           *   *   *   *   *

       ``You can't do a pharmacokinetic study if you don't have 
     the peak level. They clearly didn't have the peak level 
     because they have high stool mercury, and they have low blood 
     mercury--it doesn't make sense.''
       4. The study did not measure the effects of mercury on 
     infants, only the levels of mercury:
       While the University of Rochester study measured the levels 
     of mercury in infants' bodies at various times beyond peak 
     levels, it did not attempt to determine the effects of the 
     mercury on their bodies. This limitation was clearly brought 
     out in an exchange between Congressman Burton and Dr. 
     Christopher Portier, Director of the Environmental Toxicology 
     Program at the National Institute of Environmental Health 
     Sciences:
       Mr. Burton: ``Does the study recently published in The 
     Lancet identify the effects of mercury on infants who are 
     vaccinated with thimerosal?''
       Dr. Portier: ``No.''
       Given the small sample size, the failure to measure mercury 
     at peak levels, and the study's inability to measure the 
     effects of the ethylmercury present in the bodies of the 
     subjects, it is difficult to understand how the authors can 
     come to the broad conclusion that, ``the thimerosal in 
     routine vaccines poses very little risk to full-term 
     infants.'' If anything, the limitations of this study point 
     out the need for much more research to be done. As Dr. Baskin 
     pointed out:
       ``They described this as a descriptive study, and that's 
     exactly what it was. It provides some interesting 
     information, it's a start, but the interpretation is 
     inaccurate.''


      VII. Evidence of Ethyl Mercury's Toxicity Was Neglected By 
             Manufacturers and Federal Regulators for Years

                            A. Introduction

       Evidence of ethylmercury's toxicity was available to 
     Federal regulators and the private sector almost from the 
     product's inception. For far too long, both neglected this 
     evidence. Despite evidence dating to the 1930s that 
     ethylmercury in medicines was potentially hazardous, little 
     was done to remove it from a number of products until the 
     1980's. Even then, regulatory actions to remove thimerosal 
     and other mercury compounds from medical products proceeded 
     at a glacial pace. The decision to remove thimerosal from 
     topical ointments was not finalized until 1998. The removal 
     of thimerosal from several childhood vaccines in the United 
     States wasn't accomplished until after the turn of the 
     century. Today, the vaccine for influenza given to infants 
     still contains trace amounts of ethylmercury.
       For decades, ethylmercury was used as a preservative or 
     anti-bacterial agent in a range of products, including 
     antiseptic ointments for treating cuts, nasal sprays, eye 
     solutions, diaper rash treatments, contraceptive products, 
     and perhaps most importantly, vaccines. Several years after 
     an FDA advisory committee found that thimerosal wasn't safe 
     for use in topical ointments, new childhood vaccines 
     containing thimerosal were being approved and added to the 
     recommended schedule. It appears that nobody analyzed the 
     potential impact of the increased cumulative amount of 
     mercury to which young children were being exposed. In fact, 
     if Congress had not enacted legislation in 1997 requiring the 
     FDA to study the amounts of mercury being used in FDA-
     approved products, it is questionable that the FDA would have 
     analyzed mercury in vaccines at all.
       It is no wonder that, in its report on thimerosal, the 
     Institute of Medicine commented:
       ``The presence of mercury in some vaccines can raise doubts 
     about the entire system of ensuring vaccine safety, and late 
     recognition of the potential risk of thimerosal in vaccines 
     may contribute to a perception among some that careful 
     attention to vaccine components has been lacking.''
       It is clear that the guiding principal for FDA policymakers 
     has been to avoid shaking the public's confidence in the 
     safety of vaccines. For this reason, many FDA officials have 
     stubbornly denied that thimerosal may cause adverse 
     reactions. Ironically, the FDA's unwillingness to address 
     this issue more forcefully, and remove thimerosal from 
     vaccines earlier, may have done more long-term damage to the 
     public's trust in vaccines than confronting the problem head-
     on. Given the serious concerns about the safety of 
     thimerosal, the FDA should have acted years earlier to remove 
     this preservative from vaccines and other medicines.

  B. Thimerosal manufacturers accumulated evidence of the toxicity of 
                               thimerosal

       Eli Lilly and Company of Indianapolis licensed thimerosal 
     in 1930. It was marketed under the brand name 
     ``Merthiolate.'' It was used extensively both in topical 
     ointments to prevent infections and as a preservative in a 
     variety of medicines. However, it now appears that very 
     little research on the safety or effectiveness of thimerosal 
     was ever done.
       Eli Lilly was not the only manufacturer of thimerosal or 
     other ethylmercury products. In fact, they phased out their 
     production of thimerosal in 1974. However, Eli Lilly 
     initially patented this product and had a longer history with 
     it than any other company. Therefore, it is appropriate to 
     review Lilly's track record in ensuring the safety and 
     reliability of this product.
       A review of internal Eli Lilly documents dating back 70 
     years suggests that the only

[[Page 12734]]

     study of thimerosal involving human subjects was done prior 
     to 1930. For the next seven decades, Lilly spokespeople would 
     refer to that original study as evidence of thimerosal's 
     safety. However, it is now clear that this uncontrolled study 
     was woefully inadequate.
       As previously discussed in this study, an intravenous 
     solution containing thimerosal was tried as an experimental 
     treatment for 22 men who were seriously ill with Meningitis. 
     While the treatment was found to be ineffective, the doctor 
     who conducted the study concluded that the solution caused no 
     harmful side effects. It is clear today that such a limited 
     number of subjects, all suffering from the same serious 
     illness, would hardly qualify as a sufficiently sized random 
     sample, and a study such as this one would be of very little 
     value by today's standards. In fact, an internal Eli Lilly 
     memo from 1972 candidly notes the study's shortcomings:
       ``Considering the type of patient involved, one might 
     question these observations (the appearance of no deleterious 
     action) as providing adequate indication of any harmful 
     effects of high doses of Merthiolate in humans, in 
     particular, more long term effects.''
       In 1973, the FDA requested additional data on Merthiolate 
     from Eli Lilly. Lilly's Director of Regulatory Affairs, E.A. 
     Burrows, responded with a ringing defense of Lilly's product 
     on February 14, 1973:
       ``Due to the length of time this product has been on the 
     market, its efficacy and safety have been proven by over 
     forty years of use throughout the world. Because of this long 
     period of use, it would be difficult to get recognized 
     researchers to conduct new studies for safety or efficacy. 
     They believe that over forty years of wide usage has proven 
     efficacy and safety beyond that which could be done in 
     special studies.''
       Despite Mr. Burrow's contention, numerous internal Lilly 
     documents recognized the lack of data on thimerosal and 
     suggested the need for more research:
       An April 24, 1930, intra-office memo stated:
       ``. . . in view of our experience with the merthiolate 
     solution, we have to know pretty definitely what to expect 
     from merthiolate ointment and jelly before they are put on 
     the market . . . . Can we expect to have the stronger 
     ointment and jelly used without complaint which attended the 
     use of the solution in the same strengths? . . . Our 
     experience with the solution ought to serve as a warning and 
     certainly in the face of that warning we ought not to 
     advocate the use of the stronger products without some pretty 
     definite evidence that we will not repeat our solution 
     experience.''
       A September 1934, paper from Lilly's files states:
       ``[L]ittle is known about the effect of mercuric compounds 
     when inoculated into humans. It is therefore preferable to 
     use the minimum amount of this preservative necessary to 
     maintain the sterility of the product.''
       An April 1969, memo regarding the possible use of 
     thimerosal in contact lens solution states:
       ``When Merthiolate breaks down, are the degradation 
     products toxic or irritating? Our files yield no test 
     information on the irritancy of degraded merthiolate.''

                           *   *   *   *   *

       ``Would we recommend the use of merthiolate solution to 
     store and sterilize contact lenses? In the absence of 
     appropriate data, a positive recommendation could not be 
     made, this use does not seem unreasonable and probably would 
     not be hazardous.''
       A December 1972, memo states:
       ``A review of some data being generated by the current 
     concern for mercury in the environment suggests it would be 
     advisable to obtain data on the metabolic deposition of 
     Merthiolate . . . .''
       An August 1973, memo entitled, ``Merthiolate Toxicity,'' 
     acknowledged:
       ``The effects of long-term, intravenous use in man is not 
     known, no long-term toxicity tests have been performed.''
       Perhaps more disturbing is that Lilly's files contained 
     numerous papers and reports documenting the toxicity and 
     hypersensitivity of Merthiolate. Although these papers and 
     case reports strongly suggested the need for much more 
     research, there apparently was little follow-up.
       A July 1935, letter from the Pittman-Moore Company 
     indicated that Merthiolate was not appropriate for use in 
     dogs:
       ``We have obtained marked local reaction in about 50% of 
     the dogs injected with serum containing dilutions of 
     Merthiolate, varying in 1 in 40,000 to 1 in 5,000, and we 
     have demonstrated conclusively that there is no connection 
     between the lot of serum and the reaction. In other words, 
     Merthiolate is unsatisfactory as a preservative for serum 
     intended for use on dogs. Occasional dogs do not show the 
     local reaction, but in some instances, the reaction is 
     extremely severe. I might say that we have tested Merthiolate 
     on humans and find that it gives a more marked local reaction 
     than does phenol or tricresol.''
       A 1947 paper published by an Army physician in Baltimore 
     reported that Merthiolate was causing contact dermatitis in 
     his patients. He concluded:
       ``No eruptions or reactions have been observed or reported 
     to Merthiolate internally, but it may be dangerous to inject 
     a serum containing Merthiolate into a patient sensitive to 
     Merthiolate.''
       A 1948 paper from an Arizona doctor reported the case of a 
     woman who suffered repeated multiple reactions to Merthiolate 
     applied to her skin prior to surgery. She reportedly suffered 
     chills and fevers and had small vesicles and erythema in the 
     area of her Merthiolate application. After her recovery, the 
     patient indicated that the ulcer for which she was being 
     surgically treated appeared after repeated application of a 
     tincture of Merthiolate. She continued applying the 
     Merthiolate until her skin became too raw and painful to 
     continue use, and then sought medical care.
       A 1950 New York Academy of Sciences article entitled, 
     ``Mercurials as Antiseptics,'' found that Merthiolate ``is 
     toxic when injected parenterally and therefore cannot be used 
     in chemotherapy.''
       A 1973 article, entitled, ``Dangers of Skin Burns from 
     Thimerosal,'' reported the case of a woman who received 
     severe burns resulting from a chemical interaction between 
     thimerosal and aluminum. The article suggested that 
     thimerosal and aluminum should not be used together. Later in 
     1973, Lilly's legal department recommended new labeling 
     language for thimerosal products: ``Do not use when aluminum 
     may come in contact with treated skin.'' Unfortunately, 
     thimerosal and aluminum were used together in the DTP and 
     DTaP vaccines for years.

 C. The FDA was painfully slow to require the removal of mercury from 
                    over-the-counter (OTC) products.

       In 1974, the FDA undertook a comprehensive review of the 
     safety and effectiveness of over-the-counter medicines. As 
     one facet of this review, a panel of experts was assembled to 
     review the safety and efficacy of over-the-counter drugs 
     containing mercury. The Advisory Review Panel on OTC 
     Miscellaneous External Drug Products began this review in 
     1975. In 1980, the panel delivered its report to the FDA. It 
     reviewed 18 products containing mercury, and found them all 
     either unsafe or ineffective for their stated purpose of 
     killing bacteria to prevent infections.
       In terms of effectiveness, the panel stated that, ``mercury 
     compounds as a class are of dubious value for anti-microbial 
     use.'' They stated that, ``mercury inhibits the growth of 
     bacteria, but does not act swiftly to kill them.'' In fact, 
     the panel cited a 1935 study of the effectiveness of 
     thimerosal in killing staphylococcus bacteria on chick heart 
     tissue. The study determined that thimerosal was 35 times 
     more toxic to the heart tissue it was meant to protect than 
     the bacteria it was meant to kill.
       In terms of safety, the panel cited a number of studies 
     demonstrating the highly allergenic nature of thimerosal and 
     related organic mercury products. For instance, they cited a 
     Swedish study that showed that 10 percent of school children, 
     16 percent of military recruits, 18 percent of twins, and 26 
     percent of medical students had hypersensitivity to 
     thimerosal. They stated that while organic mercury compounds 
     like thimerosal were initially developed to decrease the 
     toxicity of the mercury ion, thimerosal was actually found to 
     be more toxic than bichloride of mercury for certain human 
     cells.
       By way of summary, they stated the following:
       ``The Panel concludes that thimerosal is not safe for OTC 
     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 
     bacteriostatic action can be reversed.''
       Despite the fact that the expert committee found thimerosal 
     and other ethyl-mercury compounds unsafe and ineffective for 
     over-the-counter products, the FDA would not formally require 
     the removal of mercury from these products for another 18 
     years. The submission of the committee's report in 1980 set 
     in motion a tortuous bureaucratic process that would not 
     result in the banning of mercury from over-the-counter 
     products until 1998. The agency published Advanced Notice of 
     Proposed Rules or Notice of Proposed Rules regarding these 
     products in 1980, 1982, 1990, 1991, 1994 and 1995.
       What makes the glacial pace of these proceedings all the 
     more mystifying is that there appears to have been no 
     opposition to this action throughout the process. No 
     individuals sought to appear before the advisory committee in 
     defense of mercury-containing products, and when the FDA 
     sought public comment along the way on proposed rules to ban 
     certain mercury-based products, it received none. At the time 
     of the FDA's final action, there were 20 over-the-counter 
     products containing mercury being marketed by eight different 
     manufacturers. Their silence on this point is telling.

 D. The FDA's actions to remove mercury from over-the-counter products 
         should have prompted a review of mercury in vaccines.

       It is difficult to understand why it took the FDA 18 years 
     to remove mercury from over-the-counter products. It is 
     equally difficult to understand why the expert panel's 1980 
     findings on thimerosal's safety in topical ointments did not 
     prompt the FDA to further and immediately review the use of 
     thimerosal in vaccines. Surely there must have been concern 
     that if it was not safe to apply ethylmercury to the surface 
     of an individual's skin, it might not be safe to inject

[[Page 12735]]

     ethylmercury deep into an infant's tissue. The Director of 
     the FDA's National Center expressed such a concern at a 1999 
     meeting for Toxicological Research, Dr. Bernard Schwetz, who 
     went on to serve as the Acting Director of the FDA for nearly 
     a year:
       ``One thing I haven't heard discussed, the fact that we 
     know that ethylmercury is a skin sensitizer when it's put on 
     the skin, and now we're injecting this IM (intramuscularly) 
     at a time when the immune system is just developing, the 
     functionality of the immune system is just being set at this 
     age. So now we're injecting a sensitizer several times. 
     During that period of time, what's the impact of a 
     sensitizer--of something that is known to be a skin 
     sensitizer, what is the effect on the functional development 
     of the immune system when you give a chemical of that kind 
     repeatedly IM?''
       Different branches of the FDA regulate over-the-counter 
     products and vaccines. OTCs are regulated by the Center for 
     Drug Evaluation and Research (CDER). Vaccines are regulated 
     by the Center for Biologics Evaluation and Research (CBER). 
     This, however, is little justification for the lack of 
     coordination. The FDA's determination that mercury was unsafe 
     and should be removed from over-the-counter medications was 
     published in the Federal Register no fewer than five times 
     prior to the FDA's belated review of mercury in vaccines.
       What finally prompted the FDA to review mercury in vaccines 
     was not its own regulatory process, but rather an act of 
     Congress. In 1997, Congress passed and the President signed 
     into law, the Food and Drug Administration Modernization Act 
     (FDAMA). Among other things, this law required the FDA to 
     compile a list of foods and drugs that contained 
     intentionally-introduced mercury, study its effects on the 
     human body, and restrict its use if found to be harmful.

   E. Federal regulators moved too slowly to remove thimerosal from 
                                vaccines

       Once the FDA did initiate its review of mercury in 
     vaccines, it kicked off a vigorous debate among Federal 
     regulators over the dangers of using thimerosal in childhood 
     vaccines. This debate, which at times pitted one health-care 
     bureaucracy against another, spanned nearly three years. 
     Given the fact that almost twenty years had passed since an 
     expert panel had determined that thimerosal was unsafe in 
     topical ointments, it is surprising that there was any 
     further debate at all.
       There was tremendous reluctance on the part of some 
     officials to admit that a mistake had been made in allowing 
     ethylmercury to be used in vaccines. There was great 
     uncertainty in others caused by the lack of data specifically 
     on ethylmercury. However, the institutional resistance to 
     change was counter-balanced by the growing realization that 
     there was more ethylmercury in childhood vaccines than 
     previously thought, and that nobody had thought to calculate 
     the cumulative amounts. The essence of the debate was 
     captured in a 1999 e-mail from a former FDA official weighing 
     the pros and cons of taking action. He opined that hastening 
     the removal of thimerosal from vaccines would:
       ``. . . raise questions about FDA being `asleep at the 
     switch' for decades by allowing a potentially hazardous 
     compound to remain in many childhood vaccines, and not 
     forcing manufacturers to exclude it from new products. It 
     will also raise questions about various advisory bodies 
     regarding aggressive recommendations for use. (We must keep 
     in mind that the dose of ethylmercury was not generated by 
     `rocket science'. Conversion of the percentage thimerosal to 
     actual micrograms of mercury involves ninth grade algebra. 
     What took the FDA so long to do the calculations? Why didn't 
     CDC and the advisory bodies do these calculations when they 
     rapidly expanded the childhood immunization schedule?)''
       It is clear that each time an important decision had to be 
     made, the factions that were skeptical of thimerosal's 
     dangers and favored a ``go-slow'' approach, were able to 
     water down the actions. In 1999, when the Federal government 
     could have ordered thimerosal removed from vaccines by a 
     specific date, or stated a preference for thimerosal-free 
     vaccines, a statement was instead issued asking for a 
     commitment from vaccine manufacturers to eliminate or reduce 
     mercury in vaccines as expeditiously as possible. As a 
     result, almost two years passed before the three major 
     thimerosal-containing vaccines--DTaP, Hib and Hepatitis B--
     were being manufactured in thimerosal-free formulations. In 
     2001, when the CDC and its influential advisory committee 
     could have stated a preference for thimerosal-free vaccines, 
     they chose not to do so. As a result, thimerosal-containing 
     vaccines that remained in stock in doctors' offices continued 
     to be used. In point of fact, we have no proof that in 2003, 
     some children in the United States are not still receiving 
     thimerosal-preserved vaccines that have lingered in medical 
     offices or clinics.
       The CDC's decision not to endorse thimerosal-free vaccines 
     in 2001 is particularly troubling. With the exception of the 
     influenza vaccine, all major childhood vaccines were being 
     manufactured without thimerosal at that time, so there was 
     little threat of shortages. Their failure to state a 
     preference was an abdication of their responsibility.
       The task of analyzing the amount of mercury in vaccines and 
     its ramifications was assigned to Dr. Leslie Ball, a 
     pediatrician employed at the FDA and her husband and 
     colleague Dr. Robert Ball, a medical officer at FDA's CBER. 
     Despite the general lack of scientific research on the 
     toxicity of ethylmercury, their review of the available 
     literature led to two working conclusions:
       1. The recommended guidelines for exposure to methylmercury 
     were a good starting point for reviewing exposure to 
     ethylmercury; and
       2. The amount of ethylmercury in children's vaccines 
     exceeded the EPA's guidelines for exposure to methylmercury.
       An exchange of e-mails in October of 1998 makes clear that 
     Dr. Leslie Ball was already leaning toward the removal of 
     thimerosal from vaccines. It also makes clear that there was 
     internal resistance to such an action. Dr. Marion Gruber of 
     the Office of Vaccine Research and Review forwarded an 
     internal FDA memo to Dr. Ball, which concluded that:
       ``. . . no scientific database to take regulatory actions 
     and to recommend to take thimerosal either out of vaccines or 
     to leave it in. In fact, somebody should perform the adequate 
     studies to come to a conclusion on the toxicity of thimerosal 
     or its metabolized forms.''
       Dr. Ball's response on October 15, 1998, to Dr. Hasting's 
     conclusion was sharp:
       ``I disagree about the conclusion regarding no basis for 
     removal of thimerosal. On a strictly scientific basis, yes, 
     there are no data that have looked at the specific issue of 
     thimerosal in vaccines. However, there are factors/data that 
     would argue for the removal of thimerosal, including data on 
     methylmercury exposure in infants and the knowledge that 
     thimerosal is not an essential component to vaccines. In 
     addition, the European community is moving to ban 
     thimerosal.''
       In a 2002 interview with Committee staff, Dr. Ball 
     confirmed that it was her opinion that, if there was any 
     question, the safest course of action should be taken, and 
     thimerosal should be removed.
       An important part of the FDA's review was a comparison of 
     the amount of ethylmercury in vaccines to the recommended 
     safe levels for exposure to methylmercury established by the 
     EPA and the FDA. In 1999, a consultant to the FDA, Dr. Barry 
     Rumack, developed a pharmacokinetic model to analyze the 
     amount of mercury to which infants were being exposed. The 
     FDA produced to the Committee two charts developed from that 
     model dated June 28, 1999. Both charts demonstrate what has 
     now become widely acknowledged, that most children in the 
     1990s received doses of ethylmercury in their vaccines that 
     exceeded the EPA's limits for exposure to methylmercury (0.1 
     micrograms per kilogram) for at least the first six months of 
     their lives. Even more significantly, the charts also 
     indicate that most children received doses of ethylmercury 
     that exceeded the FDA's less-restrictive limits (0.4 
     micrograms per kilogram) for at least the first two months of 
     their lives.
       Federal officials have never publicly acknowledged this 
     second fact. In public statements and Congressional 
     testimony, they have acknowledged only that the EPA's lower 
     limit was exceeded, even though simple math makes clear that 
     most infants also breached the FDA's higher limit of 0.4 
     micrograms per kilogram.
       Dr. Neal Halsey, Director of the Institute of Vaccine 
     Safety at Johns Hopkins University, acknowledged this 
     important fact, however. As previously mentioned, Dr. Halsey 
     became convinced that thimerosal should be removed from 
     vaccines. On June 22, 1999, Dr. Ball presented the results of 
     her research to the Medical Policy Coordinating Committee of 
     the FDA's Center for Biologics Evaluation and Review (CBER). 
     Dr. Halsey attended that meeting. The next day, on June 23, 
     1999, Dr. Halsey wrote a letter to the members of the 
     American Academy of Pediatricians' Committee on Infectious 
     Diseases, which he chaired. He stated:
       ``In the past few days, I have become aware that the amount 
     of thimerosal in most hepatitis B, DTaP and Hib vaccines that 
     we administer to infants results in a total dose of mercury 
     that exceeds the maximum exposure recommended by the EPA, the 
     FDA, CDC and WHO . . . .''
       Dr. Halsey's admission that more than just the EPA's more 
     conservative guideline was exceeded is a significant 
     departure from the public statements of most Federal 
     officials. Dr. Halsey acknowledges that the guidelines of the 
     EPA, the CDC, the FDA and the World Health Organization were 
     all exceeded.
       Another noteworthy fact is that the charts produced by Dr. 
     Rumack, and the FDA's analysis in general, failed to take 
     into consideration the background levels of mercury to which 
     children are exposed from other sources. Dr. Ball pointed out 
     this weakness in her June 1999 e-mail:
       ``These calculations do not account for other sources of Hg 
     [mercury] in the environment. Even infants can have 
     additional exposures, e.g., breast milk.''
       One document written by Dr. Ball estimated that exposure to 
     mercury from sources other than vaccines could total

[[Page 12736]]

     roughly 80 to 100 micrograms per year. Background levels were 
     included in all calculations prepared by the European Medical 
     Evaluation Agency, which was at the time reviewing thimerosal 
     in vaccines in Europe. If background levels of mercury had 
     been incorporated into the FDA's and CDC's calculations, the 
     results would have been even more pronounced, possibly even 
     leading to more aggressive measures to remove thimerosal. It 
     is unfortunate that this simple, and scientifically expected 
     step was not taken.
       The issue of what to do with thimerosal in vaccines came to 
     a head in the summer of 1999. In June and July, a series of 
     meetings were held involving the FDA, the CDC, the Public 
     Health Service, the American Association of Pediatricians, 
     and other agencies. Documents reviewed by the Committee 
     indicate that the Public Health Service opposed a public 
     effort to remove thimerosal from vaccines. One FDA document 
     stated that the Public Health Service was concerned that 
     stating a preference for thimerosal-free vaccines could 
     ``result in unwarranted loss of confidence in immunization 
     programs in the US and internationally, shortages of 
     childhood vaccines might ensue, and other potential far-
     reaching ramifications are envisioned.''
       In a July 2, 1999, e-mail, Dr. Ruth Etzel of the Department 
     of Agriculture also noted the Public Health Service's 
     resistance:
       ``We must follow the three basic rules: (1) act quickly to 
     inform pediatricians that the products have more mercury than 
     we realized; (2) be open with consumers about why we didn't 
     catch this earlier; (3) show contrition. As you know, the 
     Public Health Service informed us yesterday that they were 
     planning to conduct business as usual, and would probably 
     indicate no preference for either product. While the Public 
     Health Service may think that their `product' is 
     immunizations, I think their `product' is their 
     recommendations. If the public loses faith in the PHS 
     recommendations, then the immunization battle will falter. To 
     keep faith, we must be open and honest now and move forward 
     quickly to replace these products.''
       Adding to the pressure on the Federal government to act was 
     the fact that steps were being taken in Europe to remove 
     thimerosal from vaccines. On April 19, 1999, the European 
     Agency for Medicinal Evaluation (EMEA) met in London. The 
     EMEA is responsible for establishing guidelines for the use 
     of drugs and biologics in the European Union. The FDA's Dr. 
     Norman Baylor attended this meeting. Following this meeting, 
     on June 29, 1999, the EMEA issued a document encouraging the 
     removal of thimerosal from childhood vaccines:
       ``Vaccines: The fact that the target population for 
     vaccines in primary immunization schedules is a healthy one, 
     and in view of the demonstrated risks of thiomersal (sic) and 
     other mercurial containing preservatives, precautionary 
     measures (as outlined below) could be considered.
       ``For vaccination in infants and toddlers, the use of 
     vaccines without thimerosal [emphasis added] and other 
     mercurial preservatives should be encouraged.''
       By early July, a compromise on a course of action was 
     reached in the U.S. between the competing factions. A joint 
     statement was released by the American Academy of Pediatrics 
     and the U.S. Public Health Service. The statement included 
     the following points:
       Acknowledged that some children may have been exposed to 
     levels of mercury that exceed one Federal guideline on 
     methyl-
     mercury during the first six months of life;
       Asserted that there is no evidence of any harm caused by 
     thimerosal in vaccines;
       Called on vaccine manufacturers to make a clear commitment 
     to reduce as expeditiously as possible, the mercury content 
     of their vaccines;
       Urged doctors and parents to immunize all children, even if 
     thimerosal-free vaccines are not available; and
       Encouraged doctors and parents to postpone the Hepatitis B 
     vaccine (which contained thimerosal at the time, and was 
     generally given immediately after birth) until the child is 
     two to six months old, unless the mother tested positive for 
     Hepatitis B.
       Given the information that the Federal agencies had at the 
     time, the plan of action laid out in the joint statement was 
     inadequate. They could have, but did not, acknowledge that 
     the amount of thimerosal in vaccines exceeded every Federal 
     guideline for exposure to methylmercury for the majority of 
     infants. They could have, but did not, require vaccine 
     manufacturers to remove thimerosal from vaccines by a 
     specific date. They could have, but did not, urge 
     pediatricians to choose thimerosal-free vaccines when both 
     thimerosal-containing and thimerosal-free vaccines were 
     available.
       As a result of the limited steps taken in 1999, vaccines 
     containing thimerosal remained on the market for nearly two 
     years. GlaxoSmithKline's Hepatitis B vaccine did not become 
     thimerosal-free until March of 2000, and Aventis Pasteur's 
     DTaP vaccine did not become thimerosal-free until March 2001. 
     In addition, thimerosal-containing vaccines on the shelves in 
     doctor's offices around the country continued to be used in 
     spite of the fact that thimerosal-free versions were 
     available.
       The fact that more forceful action to remove thimerosal 
     from the vaccine marketplace was not taken in 1999 is 
     disappointing. Just as disappointing, and even more difficult 
     to understand, is the fact that the CDC, on two separate 
     occasions, refused to publicly state a preference for 
     thimerosal-free vaccines.
       In June of 2000, the CDC's Advisory Committee on 
     Immunization Practice met in Atlanta. Among other things, the 
     Advisory Committee was called upon to recommend whether the 
     CDC should issue a public statement of preference for 
     thimerosal-free vaccines. At the time, the industry was in 
     the midst of its transition to thimerosal-free childhood 
     vaccines, and several vaccines containing thimerosal were 
     still on the market. Of particular concern was the DTaP 
     vaccine. In June of 2000, three of the four DTaP 
     manufacturers (Aventis Pasteur, North American Vaccine and 
     Wyeth) were still producing DTaP with thimerosal. Only 
     SmithKline Beecham produced a thimerosal-free DTaP. In 
     addition, because manufacturers of the Hib and Hepatitis B 
     vaccines had just recently converted to formulas that were 
     thimerosal-free or contained trace amounts of thimerosal, 
     older versions of these vaccines containing thimerosal were 
     still in inventories and being used around the country.
       A statement of preference by the CDC would have been a 
     clear signal to pediatricians not to use vaccines containing 
     thimerosal, when thimerosal-free versions were available. 
     This action would have substantially reduced the exposure to 
     ethylmercury for many infants. Despite this knowledge, the 
     advisory committee voted unanimously not to state a 
     preference.
       CDC officials guided the Advisory Committee toward this 
     conclusion. For example, while three different options were 
     presented to the Advisory Committee members, a detailed 
     policy statement to be issued to the public had been prepared 
     for only one of these options--a statement of no preference. 
     In describing the three options, Dr. Roger Bernier of the CDC 
     clearly indicated the CDC's desire not to state a preference 
     for thimerosal-free vaccines. He said:
       ``We believe that such a policy would be consistent with 
     the evidence that we have at this time. The policy seems to 
     be working . . . .''

                           *   *   *   *   *

       ``As I said, the policy seems to be working. So this 
     indicates that on this particular factor, this policy is 
     moving us in an upward direction towards--it's a positive 
     thing.''
       In rejecting a statement of preference for thimerosal-free 
     vaccines, the Advisory Committee considered a number of 
     factors. These included a desire to avoid confusion, and a 
     concern that immunization rates might fall, allowing for an 
     outbreak of diseases such as Pertussis or Hepatitis B. 
     However, one of the factors that were also considered was the 
     financial health of the vaccine industry. In describing the 
     pros and cons of each option, Dr. Bernier returned several 
     times to financial issues:
       ``We think that having this type of a more staged 
     transition reduces the potential for financial losses of 
     existing inventories, and is somewhat akin to what was done 
     in the transition from oral polio to inactivated polio . . . 
     .''

                           *   *   *   *   *

       ``It could entail financial losses of inventory if current 
     vaccine inventory is wasted. It could harm one or more 
     manufacturers and may then decrease the number of 
     suppliers.''

                           *   *   *   *   *

       ``The evidence justifying this kind of abrupt policy change 
     does not appear to exist, and it could entail financial 
     losses for all existing stocks of vaccines that contain 
     thimerosal.''
       The financial health of the industry should never have been 
     a factor in this decision. The financial health of vaccine 
     manufacturers certainly should never have been more important 
     to the Federal health officials than the health and well 
     being and the nation's children. The CDC has a responsibility 
     to protect the health of the American public. If there were 
     any doubts about the neurological effects of ethylmercury in 
     vaccines on children--and there were substantial doubts--the 
     prevailing consideration should have been how best to protect 
     children from potential harm. However, it appears that 
     protecting the industry's profits took precedent over 
     protecting children from mercury damage.
       In opting not to state a preference for thimerosal-free 
     vaccines, the Advisory Committee shrugged off two sensible 
     proposals that were presented during the meeting. A 
     representative of SmithKline Beecham (now GlaxoSmithKline) 
     stated that her company could supply sufficient amounts of 
     thimerosal-free DTaP vaccine to ensure that the youngest 
     infants receiving the initial doses of DTaP could receive 
     thimerosal-free doses:
       ``I think it's important that you know that, although we 
     cannot supply the entire U.S. market right now for all five 
     doses immediately, we would be able to supply the vast 
     majority of the U.S. market for the primary series, that is 
     with targeting of the first three doses.''
       Given the repeated concerns expressed about the effects of 
     mercury on the developing central nervous system in very 
     young

[[Page 12737]]

     babies, ensuring thimerosal-free doses for the first three 
     boosters of DTaP would seem to merit serious consideration. 
     However, this suggestion was passed over without any comment.
       Later in the discussion, Dr. Neal Halsey made another 
     suggestion that would limit the exposure of infants to 
     ethylmercury. He suggested that the Advisory Committee adopt 
     a policy that no child should receive more than one 
     thimerosal-containing vaccine per day:
       ``Roger, you said that after July, the maximum exposure 
     will be 75 micrograms. My understanding from the information 
     presented from the manufacturers is that there really still 
     is some Hib out there in the market that is being used, but 
     does contain thimerosal as a preservative. There also is 
     hepatitis B out there that does contain it. So there's no 
     guarantee the maximum exposure would be 75 micrograms. What I 
     proposed last October was that they put a limit of one 
     thimerosal-containing vaccine as a preservative per visit, 
     which would then guarantee what you're looking for. And I 
     think that that's the right policy because that allows for 
     the continued use, though very limited. It eliminates the 
     maximum exposure, but you do have the problem of what's in 
     the pipeline.''
       Again, it appears that this seemingly sensible proposal 
     received no serious consideration.
       One year later, in June of 2001, the Advisory Committee 
     again rejected the idea of expressing a preference for 
     thimerosal-free vaccines, despite the fact that all 
     manufacturers of Hib, Hepatitis B and DTaP had shifted to 
     thimerosal-free products at that point. The CDC's decision 
     not to express a preference for thimerosal-free vaccines, and 
     the Advisory Committee's concurrence in this policy, was an 
     abdication of their responsibility. As a result of their 
     inaction, children continued to receive vaccinations 
     containing ethylmercury at a time when there were serious 
     doubts about its safety.
       What makes the CDC's decision even more vexing is that just 
     prior to the Advisory Committee meeting in 2000, a study 
     conducted by the CDC suggested that there was at least a weak 
     correlation between exposure to thimerosal and several types 
     of neurological disorders.
       The study, initiated in 1999, reviewed the medical records 
     of 110,000 children in the CDC's Vaccine Safety Datalink 
     (VSD). The VSD is a massive database that tracks the medical 
     records of hundreds of thousands of patients belonging to 
     seven major health maintenance organizations. Phase I of the 
     study was designed to screen data for potential associations 
     between thimerosal-containing vaccines and selected 
     neurological disorders. Phase II was designed to test the 
     hypotheses generated in the first phase.
       Phase I produced a statistically-significant association 
     between exposure to thimerosal during the first three months 
     of life, and tics, attention deficit disorder, language and 
     speech delays, and general neurodevelopmental delays. The 
     study did not find a correlation between thimerosal and 
     autism because the sample size of children diagnosed with 
     autism was in all probability not large enough.
       The findings of Dr. Verstraeten, the primary author of the 
     study, set off a fierce debate within the Federal health 
     agencies when they were released in June of 2000. Enough 
     concern was generated that a conference of medical experts 
     was assembled at the Simpsonwood Retreat Center near Atlanta. 
     At this conference, Dr. Verstraeten explained that the study 
     underreported the numbers of children with developmental 
     disorders, including autism. This occurred because the 
     youngest subjects in the study were not yet at an age at 
     which such disorders were likely to be diagnosed. He 
     commented:
       ``But one thing that is for sure, there is certainly an 
     under-ascertainment of all of these [disorders] because some 
     of the children are just not old enough to be diagnosed. So 
     the crude incidence rates are probably much lower than what 
     you would expect because the cohort is still very young.''
       Dr. Colleen Boyle of the CDC raised this issue a few months 
     earlier. She states in an April 25, 2000, e-mail to Dr. Frank 
     DeStefano, one of the study's co-authors:
       ``For me, the big issue is the missed cases--and how this 
     relates to exposure. Clearly there is a gross 
     underreporting--1.4% of the kids diagnosed with a speech and 
     language problem versus 4-5% reported in National surveys; 
     less than 1% with ADHD versus 3-10% reported previously, 
     etc.''
       Had the study been extended until these children were 
     older, a stronger correlation between thimerosal and 
     neurological disorders might have been detected, as more 
     children were diagnosed. However, this was not done. 
     Ultimately, the majority of the Simpsonwood panel determined 
     that the VSD study was not conclusive. Phase II of the VSD 
     study failed to confirm the findings of Phase I, largely 
     because of the small sample size employed (16,000, as opposed 
     to 110,000 in Phase I). The Institute of Medicine determined 
     that, ``the small sample size limited the power of the study 
     to detect a small effect, if it exists. The committee 
     concludes that the Phase I and II VSD analyses are 
     inconclusive with respect to causality.''
       Although the panel assembled at the Simpsonwood Retreat 
     Center had many unanswered questions about the VSD study, 
     some members found the evidence compelling. Dr. David 
     Johnson, Public Health Officer for the state of Michigan and 
     a member of the Advisory Committee on Immunization Practices 
     stated:
       ``This association leads me to favor a recommendation that 
     infants up to two years old not be immunized with Thimerosal- 
     containing vaccines if suitable alternative preparations are 
     available . . . I do not believe that the diagnoses justifies 
     compensation in the Vaccine Compensation Program at this 
     point. I deal with causality, it seems pretty clear to me 
     that the data are not sufficient one way or the other. My gut 
     feeling? It worries me enough. Forgive this personal comment, 
     but I got called out at eight o'clock for an emergency call 
     and my daughter-in-law delivered a son by C-Section. Our 
     first male in the line of the next generation, and I do not 
     want that grandson to get a Thimerosal-containing vaccine 
     until we know better what is going on. It will probably take 
     a long time. In the meantime, and I know that there are 
     probably implications for this internationally, but in the 
     meantime I think I want that grandson to only be given 
     Thimerosal-free vaccines.''
       One participant in the Simpsonwood panel later stated that, 
     while there was general agreement that the VSD study did not 
     prove a causal relationship between thimerosal and 
     neurological disorders, it did indicate the need for much 
     more research:
       ``So what were the responses of the consultants? With 
     regard to the first question, a need for further 
     investigation. Overall the group expressed unanimous feeling 
     that the findings supported a statistically significant, 
     although weak, association, but that the implications--for 
     obvious reasons--are profound. Therefore, the consultants 
     were unanimous in their opinion that further investigation 
     should be pursued with a degree of urgency and, 
     parenthetically, not only for public health policy in this 
     country, but for public health policy around the world.''
       Documents reviewed by the Committee indicate that Dr. 
     Verstraeten was not pleased with the response to his study. 
     During the Simpsonwood conference, he stated:
       ``When I saw this, and I went back through the literature, 
     I was actually stunned by what I saw--because I thought it 
     was plausible.''
       A month later, he sent an e-mail to Dr. Phillippe 
     Grandjean, the author of several groundbreaking studies on 
     the toxicity of mercury. Dr. Verstraeten wrote:
       ``I know that much of this is very hypothetical and, 
     personally, I would rather not drag the Faroe and Seychelles 
     studies into this entire thimerosal debate, as I think they 
     are as comparable as apples and pears at the best. 
     Unfortunately I have witnessed how many experts, looking at 
     this thimerosal issue, do not seem bothered to compare apples 
     to pears and insist if nothing is happening in these studies, 
     then nothing should be feared of thimerosal. I do not wish to 
     be the advocate of the anti-vaccine lobby and sound as if I 
     am convinced that thimerosal is or was harmful; but at least 
     I feel we should use sound scientific argumentation, and not 
     let our standards be dictated by our desire to disprove an 
     unpleasant theory.''
       It appears that many who participated in the thimerosal 
     debates allowed their standards to be dictated by their 
     desire to disprove an unpleasant theory. The decision by the 
     CDC not to state a preference for mercury-free vaccines is 
     especially difficult to understand, given the deep-seated 
     concerns many policy-makers had about the potential impact of 
     ethylmercury on the fragile central nervous systems of 
     developing babies. FDA officials spoke passionately about 
     this problem at a meeting of the National Vaccine Advisory 
     Committee in the summer of 1999. Dr. Katherine Zoon stated:
       ``We need to understand more about thimerosal because in 
     the past two days, I think we have recognized that there 
     really is a paucity of data, And I think some of the points 
     made about looking at the developing nervous system, looking 
     at the developing immune systems, and the effects of these 
     agents on that at critical times of development, hasn't 
     been--hasn't been done--and I think that knowledge is very 
     important.''
       At the same meeting, Dr. Bernard Schwetz, the Director of 
     the FDA's toxicology center, stated:
       ``. . . the sensitivity of the fetus versus the neonate is 
     very important, and for some of you who have forgotten about 
     the sensitive windows during fetal development, the nervous 
     system develops post-natally. So it isn't unreasonable to 
     expect that there would be particular windows of sensitivity. 
     So it isn't the matter of averaging the dose over the whole 
     neonatal period--it's what's the week or what's the day or 
     what's the series of hours that represent a particular event 
     in the development of the nervous system when this whole 
     thing might be dangerous. There may be weeks surrounding that 
     when there isn't a major problem. We don't have that 
     information.''


        VIII. Focused, Intensive Research Effort is Badly Needed

       One of the most consistent refrains heard by the Committee 
     throughout its three-year

[[Page 12738]]

     investigation is that not enough research has been done. The 
     Committee has heard testimony from parents, scientists and 
     government officials that much more research is needed, and 
     that well-designed unbiased research that addresses the 
     specific issues of vaccine-injury must be conducted. Areas in 
     which research is urgently needed include:
       The causes of autism.
       Treatments for those suffering from autism spectrum 
     disorders.
       Possible relationships between vaccine ingredients like 
     thimerosal and autism.
       The neurotoxicity of ethylmercury.
       The neurotoxicity of dental amalgams containing mercury.
       Immune system and gastrointestinal system dysfunction after 
     vaccination.
       In 2001, the Institute of Medicine called for much more 
     research into possible relationships between vaccines and 
     autism spectrum disorder. In its report on an alleged 
     relationship between the MMR vaccine and autism, the IOM 
     noted that it ``does not exclude the possibility that MMR 
     vaccines could contribute to ASD'' and recommended ``this 
     issue receive continued attention.'' The IOM made the 
     following research recommendations:
       Use accepted and consistent case definitions and assessment 
     protocols for ASD (autism spectrum disorder) in order to 
     enhance the precision and comparability of results from 
     surveillance, epidemiological, biological investigations.
       Explore whether exposure to MMR vaccine is a risk factor 
     for ASD in a small number of children.
       Develop targeted investigations of whether or not measles 
     vaccine-strain virus is present in the intestines of some 
     children with ASD.
       Encourage all who submit reports to VAERS of any diagnosis 
     of ASD thought to be related to MMR vaccine to provide as 
     much detail and as much documentation as possible.
       Case Reports in VAERS or elsewhere of ``rechallenge'' 
     should be identified, documented, and followed up. (In the 
     context of MMR vaccine and ASD, rechallenge refers to 
     children who appeared to have experienced some form of 
     neurological regression after a first dose of MMR or other 
     measles-containing vaccine and who appeared to have 
     experienced another regression following a second dose of MMR 
     or other measles-containing vaccine.)
       Study the possible effects of different MMR immunization 
     exposures.
       Conduct further clinical and epidemiological studies of 
     sufficient rigor to identify risk factors and biological 
     markers of ASD in order to better understand genetic or 
     environmental causes.
       In its report on thimerosal-containing vaccines and autism, 
     the IOM stated that there was not enough evidence to reach 
     any conclusions about a possible relationship between 
     thimerosal and autism spectrum disorders. The IOM called for 
     the following types of research:
       Case-control studies examining the potential link between 
     neurodevelopmental disorders and thimerosal-containing 
     vaccines;
       Further analysis of cohorts of children who did not receive 
     thimerosal-containing doses of vaccines during clinical 
     trials;
       Epidemiological studies comparing the prevalence of 
     neurological disorders in children who received vaccines 
     before thimerosal was removed to children who received 
     vaccines after it was removed;
       An increased effort to identify the primary sources and 
     levels of prenatal and postnatal exposure to thimerosal;
       Clinical research on how children metabolize and excrete 
     metals;
       Theoretical modeling of ethylmercury exposures, including 
     the incremental burden of thimerosal on background mercury 
     exposures from other sources;
       Research in appropriate animal models on neurodevelopmental 
     effects of ethylmercury;
       Rigorous scientific investigations of chelation as a 
     treatment for neurodevelopmental disorders; and
       Research to identify a safe, effective and inexpensive 
     alternative to thimerosal for countries that decide they want 
     to follow the example of Europe and the United States and 
     discontinue its use.
       One concern that has been raised many times is that 
     responsibility for research into autism and related issues at 
     the NIH has been fragmented. Responsibility is divided among 
     the National Institute of Mental Health, the National 
     Institute of Neurological Diseases and Stroke, the National 
     Institute of Child Health and Human Development, and the 
     National Institute of Environmental Health Sciences. Greater 
     overall coordination is needed. The NIH needs to develop a 
     strategic plan on autism research to bring together the 
     diverse activities, develop a strategy and timeline, and 
     focus research on the most pressing research needs.
       Another concern is the lack of a sufficient investment into 
     research on autism and its causes. Autism is growing at 
     epidemic proportions and nobody knows why. The rates of 
     autism doubled during the Committee's investigation, yet 
     funding for research on autism lags badly behind funding for 
     other serious diseases. The NIH, with a budget of $27 Billion 
     dollars last year, invested just $56 Million towards autism 
     research. Much of that research has been focused on looking 
     for genetic causes of autism, which is important, but does 
     not address the possible connection to vaccine injury. To put 
     the spending on autism in perspective, the Committee compared 
     it to the spending on two other serious epidemics--HIV/AIDS 
     and diabetes. At the same time that the NIH was spending $56 
     Million on autism research, they spent $688 Million on 
     diabetes research and over $2.2 Billion on HIV/AIDS research.
       The Centers for Disease Control and Prevention has also 
     been negligent in addressing the research needs regarding 
     vaccine injury and a connection to the autism epidemic. In FY 
     2002, the CDC invested $11.3 Million on autism, while 
     spending $62 Million on diabetes, and $932 Million on HIV/
     AIDS. With spending for autism 80 times less than that for 
     AIDS, it is obvious that CDC is not addressing the autism 
     epidemic with enough rigor. Instead, at the time of the 
     Committee's April 2002 hearing, the CDC actually planned to 
     cut autism research spending to $10.2 Million.
       Of additional concern has been the CDC's bias against 
     theories regarding vaccine-induced autism. Rather than 
     aggressively work to replicate clinical findings with 
     laboratory data that showed a relationship between vaccines 
     and autism, (the Wakefield autism entercolitis studies), the 
     CDC funded researchers who also worked for vaccine 
     manufacturers to conduct population-based epidemiological 
     studies to look at the possible correlation between vaccine 
     injury and a subset of the population that might be injured. 
     The CDC to date has relied too heavily on epidemiological 
     findings. While epidemiological studies are important, they 
     are not a substitute for focused, clinical research.
       Chairman Burton expressed some of these concerns at the 
     June of 2002 hearing:
       ``Officials at HHS have aggressively denied any possible 
     connection between vaccines and autism. They have waged an 
     information campaign endorsing one conclusion on an issue 
     where the science is still out. This has significantly 
     undermined public confidence in the career public service 
     professionals who are charged with balancing the dual roles 
     of assuring the safety of vaccines and increasing 
     immunization rates. Increasingly, parents come to us with 
     concerns that integrity and an honest public health response 
     to a crisis have been left by the wayside in lieu of 
     protecting the public health agenda to fully immunize 
     children. Parents are increasingly concerned that the 
     Department may be inherently conflicted in its multiple roles 
     of promoting immunization, regulating manufacturers, looking 
     for adverse events, managing the vaccine injury compensation 
     program, and developing new vaccines. Families share my 
     concern that vaccine manufacturers have too much influence as 
     well. How will HHS restore the public's trust?''
       It is clear that inadequate scientific evidence exists to 
     understand fully the likely damage done to a generation of 
     children who were repeatedly exposed to significant levels of 
     mercury through their mandatory childhood immunizations. 
     While the use of safe and effective vaccines for dangerous 
     infectious diseases is very important, the lack of quality 
     data addressing the risk of adverse reactions to vaccines and 
     their components undermined public support for this important 
     public health tool.


                            IX. Conclusions

       It is obvious from all accounts that there is a crisis in 
     the United States regarding the dramatic rise in autism rates 
     and the resulting strain placed on families, the education 
     system, and State Medicaid and disability programs. A further 
     crisis will ensue in the next two decades when we see an 
     explosion in the need for adult services and long-term 
     housing.
       In a further attempt to raise the level of awareness of the 
     autism epidemic, in November of 2002, Chairman Burton called 
     upon the President to announce a White House Conference on 
     autism to ``galvanize a national effort to determine why 
     autism has reached epidemic proportions in this country.'' 
     Chairman Burton suggested this would be a valuable 
     opportunity to ``bring together the best minds from across 
     the country to chart a course of scientific research to 
     uncover the underlying causes of this epidemic. . . . Mr. 
     President, you are in a unique position to provide the 
     leadership that is necessary to organize a national effort to 
     resolve these problems.'' In January of 2003, the response 
     from Bradley A. Blakeman, Deputy Assistant to the President 
     and Director of Appointments and Scheduling was, ``I do not 
     foresee an opportunity to add this event to the calendar.'' 
     It is unfortunate that the request of the Chairman, and the 
     hundreds of families who personally appealed to the White 
     House for this Conference did not appear to have been brought 
     to the personal attention of the President, who has stated 
     that ``no child shall be left behind.''
       Vaccines are the only medicines that American citizens are 
     mandated to receive as a condition for school and day care 
     attendance, and in some instances for employment. 
     Additionally, families who receive Federal assistance are 
     required to show proof that their children have been fully 
     immunized. While the mandate for which vaccines must be 
     administered is a State mandate, it is the Federal 
     Government, through the Centers for Disease Control and 
     Prevention

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     (CDC) and its Advisory Committee for Immunization Practices 
     that make the Universal Immunization Recommendations to which 
     the States refer for determining mandates. Federal programs 
     and funding to State programs provide immunizations free-of-
     charge to many children. In July of 2000, it was estimated 
     that 8,000 children a day were being exposed to mercury in 
     excess of Federal guidelines through their mandatory 
     vaccines. Given the importance of vaccination in our overall 
     public health strategy, it is imperative that the Department 
     of Health and Human Services adequately addresses the 
     concerns of families of whose children have possible vaccine-
     induced autism. The continued response from agency officials 
     that ``there is no proof of harm'' is a disingenuous 
     response. The lack of conclusive proof does not mean that 
     there is no connection between thimerosal and vaccine-induced 
     autism. What the lack of conclusive proof indicates is that 
     the agency has failed in its duties to assure that adequate 
     safety studies were conducted prior to marketing. 
     Furthermore, in the last two decades, after determining that 
     thimerosal was no longer ``generally recognized as safe'' for 
     topical ointments, the agency did not extend their evaluation 
     to other applications of thimerosal, in particular as a 
     vaccine preservative.
       One leading researcher made the following statement to the 
     Committee in July of 2000: ``There's no question that mercury 
     does not belong in vaccines.
       ``There are other compounds that could be used as 
     preservatives. And everything we know about childhood 
     susceptibility, neurotoxicity of mercury at the fetus and at 
     the infant level, points out that we should not have these 
     fetuses and infants exposed to mercury. There's no need of it 
     in the vaccines.''
       The Food and Drug Administration's (FDA) mission is to 
     ``promote and protect the public health by helping safe and 
     effective products reach the market in a timely way, and 
     monitoring products for continued safety after they are in 
     use.'' However, the FDA uses a subjective barometer in 
     determining when a product that has known risks can remain on 
     the market. According to the agency, ``at the heart of all 
     FDA's product evaluation decisions is a judgment about 
     whether a new product's benefits to users will outweigh its 
     risks. No regulated product is totally risk-free, so these 
     judgments are important. FDA will allow a product to present 
     more of a risk when its potential benefit is great--
     especially for products used to treat serious, life-
     threatening conditions.''
       This argument--that the known risks of infectious diseases 
     outweigh a potential risk of neurological damage from 
     exposure to thimerosal in vaccines--is one that has 
     continuously been presented to the Committee by government 
     officials. FDA officials have stressed that any possible risk 
     from thimerosal was theoretical, that no proof of harm 
     existed. However, the Committee, upon a thorough review of 
     the scientific literature and internal documents from 
     government and industry, did find evidence that thimerosal 
     did pose a risk.
       Thimerosal used as a preservative in vaccines in likely 
     related to the autism epidemic. This epidemic in all 
     probability may have been prevented or curtailed had the FDA 
     not been asleep at the switch regarding the lack of safety 
     data regarding injected thimerosal and the sharp rise of 
     infant exposure to this known neurotoxin. Our public health 
     agencies' failure to act is indicative of institutional 
     malfeasance for self-protection and misplaced protectionism 
     of the pharmaceutical industry.

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