Vaccine Injuries: Documented Adverse Reactions to Vaccines

Copyright © 2014 by Louis Conte and Tony Lyons

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Print ISBN: 978-1-62914-447-4

Ebook ISBN: 978-1-63220-170-6

Printed in the United States of America

I think certainly there are dedicated groups like the National Vaccine Information Center, which used to be called Dissatisfied Parents Together, and others such as Moms Against Mercury, Safe Minds, and Generation Rescue. These are the professional anti-vaccine groups, but I think the bigger group, frankly, is made of parents who become scared. They’re not sure who to trust. They’re not sure what to believe. They have this vague sense that maybe pharmaceutical companies have too much influence and maybe doctors aren’t to be trusted, and they’re choosing to delay or withhold one or more vaccines at their children’s risk.

—Dr. Paul Offit

"As a full-time professional research scientist for 50 years, and as a researcher in the field of autism for 45 years, I have been shocked and chagrined by the medical establishment’s ongoing efforts to trivialize the solid and compelling evidence that faulty vaccination policies are the root cause of the epidemic. There are many consistent lines of evidence implicating vaccines, and no even marginally plausible alternative hypotheses."

—Bernard Rimland, PhD; Director, Autism Research Institute; Editor, Autism Research Review International; Founder, Autism Society of America

CONTENTS

PART I

Chapter 1. How to Use This Book

Chapter 2. A Brief History of Vaccination

Chapter 3. Jacobson v. Massachusetts

Chapter 4. Contaminated Biologics and a Horse Named Jim

Chapter 5. The Cutter Crisis

Chapter 6. The Rise of Vaccinology

Chapter 7. DPT: Seizures and Encephalopathy

Chapter 8. The National Vaccine Injury Compensation Program—Reflection of Reality or Betrayal of a Promise?

Chapter 9. The Omnibus Autism Proceedings

Chapter 10. Vaccine Injury Cases

PART II

Chapter 11. Selected Reported Cases: 2013

Chapter 12. Selected Unreported Cases: 2013

Chapter 13. Historical Decisions Regarding Encephalopathy Manifesting Autism

Conclusion: Why Recognizing Vaccine Injury Is Important

APPENDIX

VAERS: The Vaccine Adverse Event Reporting System

How to File a Claim with the National Vaccine Injury Compensation Program

The National Childhood Vaccine Safety Act

Notes

PART I

1

HOW TO USE THIS BOOK

Vaccination has always been controversial. Proponents declare that vaccines have saved millions of lives, while critics claim that their success has been overstated and that vaccines may even be dangerous for some people. Many consider mandatory vaccinations a violation of individual rights or religious principles. Many in public health argue that vaccine mandates are justified and that anti-vaccination sentiment has reduced uptake rates in certain communities, resulting in outbreaks of preventable, and sometimes fatal, childhood illnesses. Opponents of vaccination point out that serious vaccine preventable diseases declined in severity and frequency before mass vaccination commenced due to better living conditions and the effectiveness of modern sanitation engineering.

The reality of vaccine injury has been horribly mishandled by the medical establishment for two hundred years, as we shall show. Denial, secrecy, and persecution of those who raise concerns about vaccine safety continue to this day. Are vaccines really safe and effective? Are the successes overstated? Are other public health initiatives more effective? Are vaccines acceptable to people with unique religious traditions? Are they contaminated? Do they sometimes spread the diseases they seek to prevent? Are they being over-used, and are severe diseases being replaced by vaccine-induced chronic diseases and conditions?

The fact is that vaccine injuries have happened in the past and continue to happen today. Even though reliance on vaccines has increased, mainstream medicine has never fully and transparently addressed the reality of vaccine injury. We must recognize that vaccines are drugs, and the more drugs one takes, the more numerous the adverse reactions to those drugs will be.

In the 1980s the United States addressed individual cases of vaccine injury by establishing the NVICP—the National Vaccine Injury Compensation Program—a controversial Department of Health and Human Resources program. The NVICP was intended to be non-adversarial, compassionate and generous to vaccine injury victims. However, as we write this book, Congress is considering hearings on the effectiveness of the NVICP. Many vaccine injury victims and vaccine safety advocates believe that the program is not functioning as Congress intended. The concern is that the NVICP is not an open and fair justice forum. There are also concerns that the program is keeping the reality of vaccine injury away from public inspection. While some (but perhaps not all) case decisions are posted on the United States Court of Claims website, most people don’t know that the NVICP even exists.

We intend to publish Vaccine Injuries annually. Each year’s book will feature all of the reported case decisions, by filing date, that resulted in the decision to compensate. While we have edited these cases for readability, we feel that these reported decisions, which may be referenced for legal purposes, provide an invaluable insight into the nature of vaccine injury and how the NVICP actually works. These case decisions are not easy reading. Vaccine injury can result in death and suffering. As these are public documents and petitioners have the right to file motions to redact personal information before the cases are posted, we have not removed case names. However, we ask the reader to respect the privacy of the litigants, their doctors, and expert witnesses.

We will also publish a sampling of unreported compensated cases. These cases, while public, are not reference material for legal purposes. Publishing all of the compensated cases of vaccine injury in the unreported section of the website would be excessive.

To place the current cases in context and to shed light on how the NVICP has evolved, we will also feature selected historical decisions.

The vast majority of cases filed in the NVICP do not result in compensation, as the 2013 statistical report shows.

Historically, the majority of claims have been filed for varieties of diptheria, pertussis, and tetanus and varieties of measles, mumps, and rubella vaccines. Most of these claims involved children whose alleged injuries were seizures and brain damage (encephalopathy). At the present time, the majority of cases compensated by the NVICP feature neurological injury to adults, such as Guillain-Barré syndrome (GBS), from adverse reactions to various influenza vaccines. Of the 993 NVICP cases reported for 2013, 627 were dismissed and 366 were compensated. Petitioner award amounts totaled $254,666,326.70. Since 1988, 3,540 individuals have been compensated and $2,671,223,269.97 has been paid out to victims of vaccine injury.¹

For those who have accepted the oft-repeated claim that vaccines are safe and effective, these numbers may be shocking. However, it is critical to note that these statistics do not reflect the fact that the vast majority of vaccine injuries are not even reported to the Vaccine Adverse Event Reporting System (VAERS) and that the vast majority of suspected injuries never result in NVICP filings.²

The statute of limitations for filing vaccine injury claims in the NVICP is three years. It is critical that those who claim vaccine injury have information at their fingertips so that they can act promptly.

We do not list attorney names—petitioner or respondent—in any of the cases, as we are not dispensing legal advice or providing advertising for attorneys. Be warned, however, that the burdens of acting pro se—on behalf of your self—in the NVICP are not to be underestimated. A list of the attorneys admitted to the bar of the program is available through the US Court of Claims website.³ Another good resource is the National Vaccine Information Center (NVIC), which also features a listing of attorneys and other valuable information.

We recognize that many will describe this book as anti-vaccine—a sophistic argument. Federal aviation officials who investigate airplane accidents are not anti-air travel. Aviation accidents result in notifications to pilots that explain the implications of these accidents. Consumers of vaccines deserve no less. Vaccines are drugs, and adverse drug reactions happen. Publicly disclosing them—as is often done on television drug commercials—allows consumers to make informed choices. Analyzing adverse drug reactions leads to safer drugs. This is our intention here.

Publication of compensated vaccine injury cases from the NVICP—something that has never been offered to the public—will allow the reader to assess vaccine injury. We hope our book serves as a jumping-off point for the reader’s investigation and analysis. We hope that the information provided here will lead to family discussions about vaccines and vaccine safety. We believe in informed consent and that individuals and parents, on behalf of their children, ought to have the final decision on medical choices.

2

A BRIEF HISTORY OF VACCINATION

It is important to acknowledge the devastation of disease outbreaks throughout human history. Smallpox killed an estimated three hundred to five hundred million people before the last recorded case in 1979. Typhoid fever, scarlet fever, whooping cough, diptheria, tuberculosis, and even diarrhea killed untold millions. Europe lingered in the Dark Ages for hundreds of years in no small part due to the Black Death, which killed anywhere between seventy-five and two hundred million.

Disease forever altered history in the Americas as well. Hidden Cities author Roger Kennedy claims that North America’s pre-Columbian civilization disappeared in what he termed the Great Dying—a plague that claimed an estimated thirty million lives due to the arrival of microbes from unknown pre-Columbian European visitors.¹ The early American historical perspective of an open continent was possible only because the vast majority of indigenous people had been wiped out.

It wasn’t Hernando Cortez who defeated the Aztecs. It was smallpox, inadvertently transmitted by the conquistadors, that devastated the Aztec empire. Malaria has killed untold millions in Africa, Asia, and South America.

Disease has had catastrophic impacts on civilization.

The Romans suspected the importance of clean running water and personal hygiene. The Romans, like many in the ancient world, believed that bad air—miasma—caused disease. They designed their cities with this belief in mind. Aqueducts, sewers, and public baths were the response. It has been theorized that the fall of Rome—and the loss of Roman engineering—set the stage for the scourge of disease in the Western world.

It is not known when attempts to improve human immunity began, but it is believed that inoculation—often referred to as variolation—originated in eighth-century India. The practice involved taking exudates from a person infected with a mild case of smallpox and rubbing it into a cut on the skin of a non-infected person. The person receiving the treatment would become ill but would develop immunity to the more serious version of the disease.

Inoculation was considered by the British Royal Society in 1699 and discussed in the society’s Philosophical Transactions in 1714 and 1716. After observing the inoculation in Turkey, Lady Mary Wortley Montagu became a champion for the technique in 1718—by publicly inoculating her children. A few years later, Edward Jenner would make the practice safer by inoculating his children with cowpox in order to protect people against smallpox.

In the new world, devastating smallpox outbreaks occurred throughout the 1600s and 1700s in New England. In Boston, the sick were often held under armed guard in pest houses. The smallpox mortality rate for New Englanders was near 30 percent.

The Reverend Cotton Mather was inoculation’s first American proponent when he learned of variolation from an African slave. Mather advocated for the practice during the smallpox outbreak of 1721. Mather publicly debated the issue with William Douglas, Boston’s only trained university physician. Douglas argued that inoculation—which involved direct transfers of bodily fluids—could spread smallpox that resulted in fatalities and could also spread other diseases as well, such as syphilis. These were valid criticisms of the primitive state of the technique. Douglas also felt that Mather was undermining medical authority by carrying out inoculations in haphazard fashion.

Mather, who lost his wife and children in a measles outbreak, regarded inoculations as a gift from God. Many, however, felt that the technique was an attempt to subvert the will of God and regarded it as a heathen practice. In his 1722 sermon entitled The Dangerous and Sinful Practice of Inoculation, English theologian Reverend Edmund Massey argued that diseases are sent by God to punish sin and that any attempt to prevent smallpox via inoculation is a diabolical operation.

The debate was heated. Mather’s house was firebombed, apparently in response to his support for inoculation. Mather ultimately convinced Dr. Zabdiel Boylston to experiment with variolation. Boylston experimented on his six-year-old son, his slave, and his slave’s son. Both contracted the disease and became gravely ill for several days before recovering. Boylston went on to inoculate thousands in Massachusetts.²

Ultimately, inoculation became more accepted through the work of Edward Jenner, who noted that English milk maids didn’t seem to contract smallpox and theorized that this was because they contracted non-lethal cowpox from milking cows. Jenner pioneered a new type of inoculation called vaccination—a word derived from the Latin word for cow—vacca. Jenner took cowpox virus from a cow and injected it into humans, the result being immunity from smallpox. Eventually, vaccination was embraced, and in 1840, the British government provided vaccination free of charge. Variolation was replaced by vaccination and ultimately banned. Jenner became known as the father of immunology.

Many of America’s founding fathers supported inoculation and, subsequently, vaccination. Benjamin Franklin’s advocacy of inoculation was driven by the death of his son, Frankie, apparently due to smallpox. There were also rumors that Frankie died from an adverse reaction—protracted diarrhea—to inoculation.³ Franklin denied this rumor and publicly supported inoculation.

John and Abigail Adams were also proponents. John Adams suffered a horrible two-week illness after being inoculated. Abigail also suffered an adverse reaction.

Inoculation was rough business. People in colonial America understood that the procedure often included adverse reactions, injury, and even death. The willingness to take the risks involved in early inoculation had to be weighed against the scourge of smallpox. Desperate times meant desperate measures.

Smallpox inoculation efforts triggered riots in Norfolk County, Virginia. Thomas Jefferson, then a young lawyer, defended the victims of the Norfolk riots, including a Dr. Archibald Campbell, whose house was burned down. Ultimately, it was Thomas Jefferson who became vaccination’s biggest American advocate. Jefferson, who corresponded with Edward Jenner, was greatly influenced by Harvard’s Benjamin Waterhouse, one of New England’s only European-trained doctors. Waterhouse is largely regarded as the man who championed early vaccination in the United States.

Jefferson was, to put it mildly, distrustful of American doctors, remarking that whenever he saw three physicians together he looked up to discover whether there was not a turkey buzzard in the neighborhood.⁴ Jefferson was enamored with Waterhouse due to his European scientific training. Working with Waterhouse, Jefferson dispatched smallpox vaccines to southern cities only to find that the vaccines didn’t work. Vaccine antigens were transported on pieces of cotton thread. They often failed to work because the antigen lost effectiveness. Jefferson realized that the vaccines had gone bad due to poor storage and came up with a an early form of insulated packaging—a corked bottle sealed in another corked bottle filled with water. The new packaging worked, and successful vaccination programs were established in Washington, Petersburg, Richmond, and other parts of the South. Jefferson successfully vaccinated seventy-eight family members, noting minor adverse reactions in great detail.

Despite his successes with Jefferson, Waterhouse was not without detractors. Some claimed that he was arrogant and pushed vaccination for personal profit. The primitive nature of early vaccines and the lack of sanitary procedures caused disease outbreaks because the vaccine often contained smallpox as well as cowpox. The public didn’t immediately embrace vaccination, and the American medical establishment never fully embraced Waterhouse. Regardless, Waterhouse pushed his vaccine agenda and ultimately prevailed.

Mainstream medicine embraced vaccination during the late 1800s. Louis Pasteur developed the germ theory of disease in 1877, and new vaccines for other diseases soon followed. Pasteur produced the first live attenuated bacterial vaccine for chicken cholera in 1879 and a rabies vaccine in 1885. Cholera and typhoid vaccines were developed in 1896, and a vaccine for plague came in 1897.

England ultimately passed vaccination acts, which first only encouraged vaccination. In 1853, vaccination of infants became mandatory, with the highest penalty for refusal being incarceration. The 1867 law extended the requirement to fourteen-year-olds, and a backlash followed. In advance of the passage of the 1867 law, Richard Gibbs, who administered the London Free Hospital, started the first Anti-Compulsory Vaccination League in 1866. Gibbs regarded compulsory vaccination to be an infringement of individual freedom. According to Gibbs, the purpose of the League was to overthrow this huge piece of physiological absurdity and medical tyranny . . . I believe we have hundreds of cases here, from being poisoned with vaccination, I deem incurable. One member of a family dating syphilitic symptoms from the time of vaccination, when all the other members of the family have been clear. We strongly advise parents to go to prison, rather than submit to have their helpless offspring inoculated with scrofula, syphilis, and mania.⁵

Gibbs was clearly describing what he felt were vaccine injuries. He also claimed that many family members of the vaccine-injured had presented petitions to Parliament alleging that their children had died but that these petitions had not been made public.

William Tebb, a businessman from Manchester, eventually took up the mantle from Gibbs. Tebb is described as being a radical liberal and was a member of several liberal organizations, including the Society for the Prevention of Cruelty to Children, The National Liberal Club, the New Reform Club, and the Vigilance Association for the Defence of Personal Rights. Tebb sought the repeal of the vaccination acts and was prosecuted and fined thirteen times for refusal to vaccinate his third daughter. He eventually became president of the National Anti-Vaccination League in 1896 and traveled to the United States in 1897 to campaign against smallpox vaccinations. Smallpox epidemics resumed in the United States, allegedly due to low vaccination rates. Whether this was true or not is debated, but it is certainly true that Tebb’s visits spawned the establishment of American anti-vaccination leagues.

The Leicester Method

English anti-vaccination sentiment gained strength due to the popularity of an alternate disease fighting approach called the Leicester method. Advocates of the approach noted that vaccination didn’t necessarily provide immunity as some vaccinated people died from smallpox—and from vaccine reactions.

The city of Leicester’s vaccination inspector began prosecuting parents who stupidly refused to have their children vaccinated. Arrests for defying the Vaccination Act went from two in 1869 to 1,154 in 1881. In some cases, magistrates issued fines, but in most cases the parents deliberately allowed themselves to be sent to goal (jail).⁶

John Thomas Biggs emerged as an opponent of compulsory vaccination and became the outspoken advocate of the Leicester method. Biggs opposed compulsory vaccination as being an infringement upon, and invasion of, personal liberty. It is said that one of his brothers suffered a vaccine injury.⁷

Biggs was a sanitary engineer, a member of the Leicester town council, and alderman, magistrate, and member of the Derwent Valley water board. He was also appointed by the Leicester Board of Guardians to develop and present its Memorial and Statistical Tables—a skill set he used to document the advantages of his Leicester method over vaccination.

Biggs kept meticulous records and studied the smallpox epidemic of 1871–1873 closely. He became convinced that vaccination wasn’t efficacious and didn’t prevent disease or mitigate its severity. Biggs collected data that showed that vaccination was not as effective as mainstream medicine purported. He published his findings in 1912 in Leicester: Sanitation versus Vaccination. The Leicester method is described by Biggs as follows:

A new method for which great practical utility is claimed has been enforced by the sanitary committee of the Corporation for the stamping out of small-pox, and the chairman of the Committee has gone so far as to declare that small-pox is one of the least troublesome diseases with which they have to deal. The method of treatment, in a word, is this: As soon as small-pox breaks out, the medical man and the householder are compelled under penalty to at once report the outbreak to the Corporation. The small-pox van is at once ordered by telephone to proceed to the house in question the hospital authorities are also instructed by telephone to make all arrangements, and thus, within a few hours, the sufferer is safely in the hospital. The family and inmates of the house are placed in quarantine in comfortable quarters, and the house thoroughly disinfected. The result is that in every instance the disease has been promptly and completely stamped out at a paltry expense . . . use plenty of water, eat good food, live in light and airy houses, and see that the Corporation kept the streets clean and the drains in order. If such details were attended to, there was no need to fear smallpox . . .

The effects of narrow, ill-conditioned streets; of imperfect drainage and improper dwellings; of circumstances of environment; and of inherited physical disability must, and will for a time, continue. These adverse elements are being gradually eliminated . . . the Leicester Method of Sanitation could bid defiance not to smallpox only, but to other infectious, if not to nearly all zymotic, diseases. Even for small-pox, not even the merest tyro among Jennerian votaries would now venture to claim that vaccination could achieve all that sanitation has accomplished. This is self-evident, because even pro-vaccinists, of the most pronounced type, now supplement the Jennerian operation with the Leicester Method of dealing with the disease. They dare not, as aforetime, trust solely to vaccination. To do so would, on their part, be culpable, if not in the highest degree criminal, neglect.⁹

Biggs compiled statistical data showing that his method worked just as well, if not better than, vaccination—and without vaccine injuries. Biggs took on the pro-vaccine medical establishment and produced evidence of vaccine injuries:

I presented a table (pages 417-433, Fourth Report, Royal Commission) of 109 deaths, 186 cases of injury (many of them permanent), and two of small-pox, following on vaccination, being a total of 297 cases in Leicester and neighbourhood, with the names, addresses, and details, each case being vouched for by the parents themselves. It is a harrowing, heart-rending catalogue. This gruesome testimony caused considerable questioning by the Commissioners, who, however, hesitated to accept such personal statements, unless supported by expert medical opinion! The evidence of careful, loving mothers, who had unintermittently tended their suffering little ones, was, it seems, not deemed trustworthy without being thus peculiarly confirmed! Was it likely that medical men would convict either themselves or their brethren? Manifestly, those parents (who had accepted vaccination) must have been in its favour, rather than against it. Otherwise their children would certainly not have been vaccinated.

The most striking points in Table 1 are:

(1) That the highest death-rates from erysipelas, both under one year, under five years, and at all ages, are concurrent with the highest years of vaccination ; and

(2) That each death-rate practically touches its lowest point coincidentally with the lowest percentage of vaccination.

By no stretch of the imagination, nor by any subterfuge, can these facts be made to tell in favour of vaccination. On the other hand, there is abundant and undeniable evidence that the practice operated most fatally.

Biggs even alleged that medical authorities were engaging in fear mongering to motivate parents to vaccinate, a claim often made by present-day vaccine safety advocates. He took on mainstream medicine’s support for vaccination. British authorities attempted to prosecute Biggs on several occasions, but Biggs always prevailed. His Leicester method resonated in England and offered a viable alternative to vaccination. The 1898 vaccination law allowed for conscientious objection to compulsory vaccination. England still allows conscientious objection today.

3

JACOBSON V. MASSACHUSETTS

The United States in 1905 was a very different place than it is today. With the start of the Industrial Revolution, more and more people poured into cities. The streets were full of sewage and animal excrement, as modern sewage and waste disposal systems had not yet been invented. Cramped housing conditions were atrocious—cold, dark and miserable in the winter; sweltering and oppressive in the summer. Many apartments didn’t have running water. The fortunate few had communal outhouses in the yard behind the building. Slaughterhouses were often located in urban centers. Many lived in sprawling shanty towns that we would compare to modern refugee camps.

These conditions–which Biggs and proponents of the Leicester method sought to mitigate–provided a breeding ground for disease.

Also driving disease was the horrendous treatment of children who were marginally educated, often forced into labor by age seven and exploited in every conceivable manner. Children were often the victims of harsh working conditions, industrial accidents, and toxic exposures.

Food was nutritionally deficient and often a source of disease. Refrigeration technology had not yet been developed, and food inspection was still years away. Clean water was often scarce, and people drank alcoholic beverages instead. People rarely bathed.

The conditions of the masses were miserable and fueled disease outbreaks that killed thousands. Proper medical care was rare. Death and misery were ubiquitous. People—and government—were desperate.

This was the reality of public health when the Jacobson case went before the US Supreme Court in 1905. Henning Jacobson, a Swedish immigrant and minister from Cambridge, Massachusetts, refused vaccination during a smallpox outbreak in 1902. Jacobson claimed that a vaccine had made him seriously ill as a child. He also claimed that a vaccine had injured his son and that he knew of others who had been injured. He refused to pay the $5.00 fine, and the Massachusetts courts rejected his arguments that the compulsory inoculation violated the state and US constitutions.

Jacobson offered to prove that vaccination ‘quite often’ caused serious and permanent injury to the health of the person vaccinated; that the operation ‘occasionally’ resulted in death; that it was ‘impossible’ to tell ‘in any particular case’ what the results of vaccination would be, or whether it would injure the health or result in death . . . that vaccine matter is ‘quite often’ impure and dangerous to be used . . . that the defendant refused to submit to vaccination for the reason that he had, ‘when a child,’ been caused great and extreme suffering for a long period by a disease produced by vaccination; and that he had witnessed a similar result of vaccination, not only in the case of his son, but in the cases of others.¹

The US Supreme Court didn’t accept that Jacobson’s fear of vaccine injury outweighed the public health authority of Massachusetts. The Supreme Court ruled that freedom of the individual must sometimes be subordinated to common welfare. The $5.00 fine was upheld—nothing more than that. The Court ruled that Massachusetts acted reasonably in fining Jacobson in the context of requiring adults to be vaccinated in an epidemic of an airborne disease.

Children were not to be subjected to the mandate, as they were believed to be too fragile.

It is important to realize that mandatory vaccination today occurs in a very different context. Children are the primary targets of mandates. Vaccines today are mandatory today not because of an ongoing catastrophic epidemic of airborne disease. The seventy doses of sixteen vaccines presently recommended are mandated in the name of herd immunity. Yet refusing vaccination can have real implications for an individual’s educational and even employment opportunities. Medical and religious exemptions to vaccine mandates are often subject to government review.

Jacobson is cited as the foundation of public health law but should be viewed within the realities of American culture at the turn of the twentieth century—and the diseases that affected that culture. Modern vaccines that protect against diseases that may be sexually transmitted, such as Gardasil, are qualitatively different from those designed to protect against airborne diseases, such as smallpox.

Jacobson was supported by the Massachusetts Anti-Compulsory Vaccination Association. There were a number of Anti-Vaccination Leagues emerging around the United States by the early 1900s. As it did for Henning Jacobson and J. T. Biggs, concern over vaccine injury fueled their development.

The anti-vaccine movement mobilized following the decision, and the Anti-Vaccination League of America was founded three years later in Philadelphia to promote the principle that health is nature’s greatest safeguard against disease and that therefore no State has the right to demand of anyone the impairment of his or her health. The league warned about what it believed were the dangers of vaccination and the dangers of allowing the intrusion of government and science into private life, part of the broader process identified with the progressive movement of the early twentieth century. The Anti-Vaccination League of America asked, "We have repudiated religious tyranny; we have rejected political tyranny; shall we now submit to medical tyranny?"²

4

CONTAMINATED BIOLOGICS AND A HORSE NAMED JIM

Vaccine manufacturing in the years around the time of the Jacobson decision was vastly different from today. The serum for diphtheria antitoxin was derived from horse blood.¹ There was no regulation or standardized controls over biological drugs. Like many business ventures of the time, the industry that produced vaccines and other drugs was not regulated by government.

In 1901, a retired milk wagon horse named Jim was found to be the source of contamination that caused the death of thirteen children in St. Louis, Missouri. Jim produced over seven gallons of serum over his lifetime. The tragedy was completely avoidable, as the contaminated serum could have been detected by the technology of the day, but samples from Jim, taken on different days, were mislabeled.²

The deaths brought the reality of vaccine injury and contaminated biologics to greater public attention. When a contaminated smallpox vaccine caused a child’s death in Camden, New Jersey, enough was enough. Congress responded with the Biologics Control Act, also known as the Virus-Toxin Law, in 1902. This act is critical because for the first time, the government conducted oversight of the processes used for the production of biological products through the establishment of the Hygienic Laboratory of the US Public Health Service. The laboratory was charged with regulating the production of vaccines and antitoxins. Producers of vaccines now had to be licensed annually for the manufacture and sale of vaccines, serum, and antitoxins. Manufacturing facilities were inspected, licensed, and monitored by scientists. Products now had to be labeled by product name, expiration date, and address and license number of the manufacturer.

The deaths in St. Louis were a wake-up call that showed the danger posed by contaminated biological products. Diphtheria antitoxin was made by inoculating horses with increasingly concentrated doses of diphtheria bacteria. The horse was then bled to collect blood serum, which was bottled as antitoxin. The horse’s serum was then injected into a patient suffering from diphtheria in the hopes that the antibodies in the serum would cure the patient. However, the threat of contamination loomed over every stage of the production process. The importance of the Hygienic Laboratory and the importance of its health officers became obvious. By 1907, clear standards were established to prevent contamination. The research at the laboratory led investigators into emerging sciences, such as immunology, in order to better understand why sudden deaths sometimes followed repeated injections of biologics made from foreign protein, such as horse serum.

Within a few years, Congress passed the Federal Food and Drugs Act to regulate the production of food and other products. Ultimately, the Food and Drug Administration was created. The deplorable health conditions of that time were being driven back not by vaccines–they were still an emerging technology fraught with contamination risks–but by an understanding that regulation of industry to improve medicines, foods, and other products could improve public health.

In 1914, Dr. Joseph Goldberger, an epidemiologist with the United States Public Health Service who worked at the Hygienic Laboratory, identified the cause of pellagra, a scourge of poor Southerners. Pellagra was caused by a niacin deficiency and could be cured through the use of brewer’s yeast. Then Earl B. Phelps, director of the Division of Chemistry at the Hygienic Laboratory, identified how pollution affected oxygen levels in lakes and rivers.

The new public health establishment was focusing on