Bad Shot? 

It's never easy for a parent to challenge accepted medical wisdom about what's best for a child's health, particularly when it comes to early-childhood shots. Vaccines are now considered such an essential part of pediatric health care that the government recommends children receive 39 doses of 12 different vaccines by the age of 5. Refusing to vaccinate a child against debilitating and deadly diseases such as polio, smallpox, measles and rubella makes a parent seem negligent in many people's eyes. Most public schools, colleges and universities won't register a student who isn't inoculated. In most places, in fact, not inoculating is illegal.

Still, each year a small number of parents choose not to vaccinate their children because of religious, philosophical or health concerns -- something the law permits in Vermont. In 1995, Burlington attorney Jim Schumacher was clerking for a law firm that represented a woman involved in a child-custody battle with her ex-husband over her refusal to vaccinate their children. She had heard horror stories about the possible consequences of vaccines, including autism, learning disabilities, diabetes and, in rare instances, brain damage and death.

Schumacher's job was to summarize 40 articles supporting the ex-wife's position. Among them was an obscure journal article claiming that, back in the 1950s and '60s, the polio vaccine was widely contaminated with a potentially carcinogenic monkey virus.

"I was just blown away," Schumacher recalls today. "I came home and told this to [my wife] and said, 'We should write about this. This is just incredible!'"

Over the next few years, Schumacher and his wife, investigative reporter Debbie Bookchin, delved into the history of the polio vaccine and the growing debate in the scientific community about the possible health effects of SV40, a little understood simian virus. Unwittingly, the Burlington couple had stumbled upon what they would later call "one of the biggest blunders in medical history."

Neither Bookchin nor Schumacher is a scientist, though for a time, Schumacher considered following in his father's footsteps and studied to become a physician. Bookchin, daughter of the internationally known author and social ecologist Murray Bookchin, has been a journalist since 1979 and spent much of the 1980s working for the Rutland Herald and the Vanguard Press. Since then, the award-winning writer has been published in numerous newspapers and magazines, including The New York Times, The Boston Globe, Boston Magazine, The Atlantic Monthly, The Nation and Utne Reader. Schumacher, who has also been published nationally, is an attorney and now works as a consultant for municipalities around the country. He and Bookchin met in the early 1990s while they were both working for Congressman Bernie Sanders.

The couple soon began piecing together the facts behind a frightening but irrefutable story: Between 1954 and 1963, roughly half of the U.S. population -- nearly 100 million Americans and untold millions more worldwide -- were given a polio vaccine that was contaminated with a cancer-causing monkey virus. For decades, this story remained virtually unknown outside of scientific circles.

Now, on the 50th anniversary of Jonas Salk's test trials for the polio vaccine, Bookchin and Schumacher have released a meticulously researched and thoroughly documented book, The Virus and the Vaccine, tracing the development of the polio vaccine and the ensuing discovery of SV40. It's a story eerily reminiscent of The Hot Zone, only more disturbing, considering the staggering number of people who were exposed to this carcinogenic agent.

But The Virus and the Vaccine is more than a fascinating history lesson. It's also a cautionary tale about how the federal regulatory agencies that were supposed to safeguard consumer health not only allowed a dangerous contaminant to be given to millions of healthy children, but also kept quiet about it for years out of fear of disrupting the public's faith in vaccines.

Worse, once the source of that contamination was identified -- the cancer-causing virus was traced to rhesus monkey kidneys used to produce the polio vaccine -- the government still refused to mandate a safer method of vaccine production, even though viable alternatives were being used successfully in other countries.

Perhaps most egregious, Bookchin and Schumacher said in a recent interview with Seven Days, newer polio vaccines may have been contaminated with SV40 as recently as January 2000, when the last vaccines produced using monkey kidneys were removed from the market. This potentially disastrous contamination occurred decades after vaccine manufacturers and the U.S. government claimed that the problem had been corrected.

In January 1997, Bookchin and Schumacher pitched the story to The Boston Globe and followed that article with another in The Atlantic Monthly in February 2000. Both pieces served as the basis for The Virus and the Vaccine, their first book together.

Though the 380-page volume is steeped in detailed and well-annotated science, it's an accessible read. The pair has crafted a real page-turner that is part detective story, part government cover-up. And like any good expose, it lays out the tangled web of bureaucratic stonewalling, scientific dogma and financial self-interest that for decades concealed a serious health risk from the public. The story's colorful cast of characters includes powerful and egotistical men who refused to question their own deeply entrenched beliefs, as well as unsung heroes who toiled in virtual anonymity and sacrificed their professional reputations and careers in the name of scientific truths.

"You really think of science as kind of a rarefied, disinterested pursuit based completely on facts and objective truths," says Bookchin. "And the government in the United States is supposed to play a disinterested, activist role. But, as the story of SV40 shows, that hasn't always worked the way it's supposed to."

*****

The polio vaccine was, literally, the shot felt around the world. Salk's discovery all but eradicated -- in the industrialized world, at least -- a debilitating and deadly childhood disease. The U.S. government's polio-eradication program laid the groundwork for the mass-inoculation programs that became the cornerstone of American public-health policy.

Many Americans today are too young to have known the fear and horror that once accompanied the annual start of "polio season." At its peak in 1952, about 58,000 new cases of polio were diagnosed -- one in every 3000 Americans -- killing more children that year than any other infectious disease. "Polio was becoming America's bête noire," Bookchin and Schumacher write, "as dangerous as the Red Menace, and just as insidious -- an unseen enemy within, a crippler and killer that seemed unstoppable, viciously cruel, with a penchant for young victims."

Ironically, the wild poliovirus, which seemed to rage haphazardly through the population proved surprisingly difficult to grow in a laboratory. Unlike bacteria, viruses require a "substrate" of living cells to reproduce, and since laboratory rodents are unaffected by it, the next logical choice was the rhesus monkey. In 1950, Salk, then at the University of Pittsburgh, discovered that ground monkey kidneys could produce a high yield of the poliovirus in record time, and at a fraction of the cost of earlier methods.

Salk's choice of rhesus monkey kidneys proved to have monumental consequences. The kidney is a storehouse for all the microorganisms filtered from the blood. But for researchers at the time, the easy accessibility and cheap supply of rhesus monkey kidneys made them an ideal growth medium.

By the summer of 1952, Salk believed he had perfected the technique of "inactivating" the poliovirus and began conducting vaccine field trials. They were an unqualified success. Two years later, on April 26, 1954, a 6-year-old boy named Randy Kerr of Falls Church, Virginia, became America's first "polio pioneer," one of 2 million children in 44 states inoculated with the Salk vaccine or an identical-looking placebo. Salk was awarded the Nobel Prize in medicine for his development, and his name became synonymous with the polio cure.

However, less-publicized problems arose almost immediately. Previously unknown strains of simian viruses began contaminating batches of the vaccine. The first "SV1" was isolated in February 1954; the second, just months later. Initially, researchers didn't worry much about these rogue viruses. Given the deadly scourge of polio, their attitude was "better the devil you know than the devil you don't," says Bookchin.

But soon a more urgent crisis shook America's confidence in the Salk vaccine. In 1955, vaccine manufacturer Cutter Laboratories distributed a batch of vaccine that inadvertently contained live poliovirus. The so-called "Cutter incident" resulted in 260 people contracting polio, including 200 cases of paralysis and 11 deaths. Investigations revealed that other vaccine manufacturers were also having serious problems with rogue viruses contaminating their vaccines. But while the immediate problem may have been addressed, its underlying cause -- the practice of using monkey kidneys -- continued unabated. "Despite the Cutter deaths, the lesson -- as far as the federal government was concerned -- was that there was no need for increased surveillance of the manufacturers," write Bookchin and Schumacher.

By 1960, tens of millions of Americans had received the vaccine, seemingly with no major problems. Meanwhile, simian viruses continued to crop up, though scientists considered them little more than a nuisance. But one researcher, Bernice Eddy, at the government's newly formed Division of Biologic Standards, began investigating the new field of "viral oncology" -- the relationship between viruses and cancer. Eddy had discovered that laboratory mammals injected with certain mouse viruses developed tumors. Would a monkey virus do the same thing in humans? And if it did, were any of the simian viruses that had contaminated early batches of the polio vaccine carcinogenic?

Eddy's public suspicions about the safety of the polio vaccine not only impugned the reputation of her agency, but also proved to be professional suicide for her. Far from being commended by her bosses for her scientific curiosity, Eddy was effectively stripped of all her responsibilities in vaccine-control work and literally relegated to a former broom closet on the campus of the National Institutes of Health.

"Millions of children would continue to receive live SV40 as part of their Salk injections," write Bookchin and Schumacher. "As had been the case with the Cutter incident, the official conclusion was that the nation's polio program was simply too important to interrupt, despite a known problem with the vaccine. But, unlike Cutter, this time the federal government would keep the news to itself."

In 1963, a highly publicized epidemiological study conducted by the NIH's Joseph Fraumeni concluded that people who had received doses of SV40-contaminated vaccines were no more likely to contract cancer than those who had not. As Schumacher and Bookchin found, that study was "deeply flawed." Still, for the next three decades, it was a widely accepted medical "fact" that SV40 was harmless to humans.

Thirty years after Eddy's findings, NIH scientist Michele Carbone discovered a link between SV40 and malignant mesothelioma, a deadly cancer of the lungs, heart and abdominal cavity that was virtually unknown before 1955 but now kills about 2500 Americans each year.

Although mesothelioma is usually tied to asbestos exposure, recent studies suggest that those who have SV40 in their bodies may be more susceptible to the disease. Scientists don't yet understand why, though a researcher at the University of Vermont has been looking into the links between SV40 and cancer. Dr. Brooke Mossman is the director of UVM's Environmental Pathology Department and an internationally renowned expert on mesothelioma. Next month, she plans to submit a multi-million-dollar grant request to the NCI with Dr. Carbone, now associate professor of pathology at Loyola University Medical School in Chicago. As Bookchin learned last week, their goal is to study how mesothelioma originates, its relationship to SV40 and genetics, and whether the simian virus makes the deadly cancer even more pernicious.

Today, certain facts about SV40 are undisputed. The U.S. Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI) admit that between 1955 and 1963, an unknown number of Salk vaccines were contaminated with SV40 and given to millions of Americans. Both agencies also acknowledge that SV40 has been shown to cause cancer in laboratory animals.

However, those same agencies also contend that once the SV40 contamination was confirmed, no further vaccines were contaminated and no one else was infected. For example, the CDC website notes, "The majority of evidence suggests there is no causal relationship between receipt of SV40-contaminated vaccine and cancer." That webpage, Shumacher points out, hasn't been updated for more than two years.

The NCI also seems to be clinging to outdated information. "Over the last four decades, an intensive research effort has been made to determine whether this route of exposure to SV40 has caused health problems in people, including cancer," the NCI website notes. "Epidemiology studies involving decades of observations in the United States and Europe have failed to detect an increased risk in those likely to have been exposed to the virus."

But even with a growing body of evidence linking SV40 to cancer, there has been very little public funding in the United States for SV40 research that could lead to cancer therapies. Just as importantly, Bookchin and Schumacher say, no one even knows if SV40 is spreading in the population, or if it is passed from parent to child.

Overseas, there is considerably more open-mindedness about SV40. Researchers in England, Italy, Japan, China and elsewhere have completed more than 90 peer-reviewed studies linking SV40 to at least four different types of human cancer. As Shumacher said last week, U.S. public-health officials' unwillingness to revisit their own science about SV40 is "unconscionable and disgraceful," especially since some virologists familiar with SV40 now estimate that as many as one in 10 Americans carries the virus.

Moreover, the U.S. government's resistance to reopening the case on SV40 may be leaving government scientists behind the curve. Just a few weeks ago, for example, the M.D. Anderson Cancer Center in Houston announced that in a study of tumors removed from people newly diagnosed with non-Hodgkin's lymphoma, about half showed evidence of SV40. Those researchers believe that SV40 "participates" in the development of the blood cancer, for which there is no other known cause, but whose incidence has doubled in the United States in the last 30 years.

Despite their findings, Bookchin and Schumacher are not blanket opponents of vaccination programs -- their own daughter was vaccinated, they admit. "Ultimately, vaccines are critical public-health tools. They absolutely are," Bookchin says emphatically. "What you want is a situation in which consumers feel they can rely on the judgment of a governmental agency that something is safe."

She adds, however, "There's a fear [in government] that if any vaccine is deemed unsafe, in particular the polio vaccine, which is the sacred cow of vaccines... that people may become reluctant or fearful in general about vaccines."

This view is shared by Barbara Loe Fisher, cofounder and president of the National Vaccine Information Center, a Virginia-based consumer-advocacy group that's pushing for more funding and research into vaccine safety. Fisher, whose own son was permanently injured by an adverse reaction to the DPT vaccine, was a prime mover behind a 1986 federal law known as the National Childhood Vaccine Injury Act. That legislation created a no-fault compensation system for families whose children have been injured or killed by reactions to vaccines. Since 1990, the program has paid out more than $1 billion to more than 1000 families nationwide.

In a recent phone interview from her home in Virginia, Fisher called The Virus and the Vaccine "a critically important work" that "exposes the true lapses in judgment and cavalier attitudes at the federal level toward vaccine safety in general." Far too little research has been done, she says, to understand the impact that vaccines have on children's immature immune systems. Each year, the CDC receives between 12,000 and 14,000 reports of adverse reactions to vaccines, a number, Fisher believes that reflects only a small fraction of the actual incidence. "It's a tiny drop in the bucket of what's occurring out there," she says.

Fisher also argues that vaccines may be at least partly to blame for the dramatic rise in a variety of childhood illnesses and disorders. For example, the rates of learning disabilities, ADHD and childhood asthma in children in the United States have doubled in the last two decades. The rate of diabetes has tripled, and there's a 200 to 600 percent increase in autism. The latter, some suspect, may be the result of the measles-mumps-rubella vaccine.

The lessons to be learned from The Virus and the Vaccine reach well beyond childhood vaccination programs. After 9/11 the Bush administration, fearing a biological weapons attack, tried to implement a nationwide smallpox vaccination program for all health-care workers. But when tens of thousands of medical professionals refused to subject themselves to the vaccine -- saying, in effect, that it posed a greater health hazard than the risk of contracting smallpox in the wild -- the program was scuttled.

Similar fears have arisen among U.S. military personnel and their families in light of the health problems experienced by returning Gulf War veterans. "We have talked to scientists who are absolutely convinced that the Gulf War Syndrome is, at least in part, due to the anthrax vaccine, along with 17 other vaccines that were given to soldiers in one day," says Schumacher.

Meanwhile, deadly new diseases continue to crop up with alarming frequency -- West Nile, SARS avian flu -- forcing scientists to investigate how all these animal viruses are jumping the species barrier. "That's why dismissing SV40 out of hand just doesn't make any scientific sense," Shumacher says. "Even if it turns out after years and years of good research that the conclusion is that it's basically okay, given the millions of people who were exposed, why wouldn't we want to know for sure?"