A Shot in the Dark
Pat Wechsler, New York, November 11,1996
When a vaccine became available that would eradicate polio, a panicked government rushed it to the public. But did it act too quickly? Early batches of the vaccine were contaminated with a monkey virus that now may be linked to cancer. And New York is one of the areas most at risk.
In the late fifties and early sixties, approximately 9 million New Yorkers--most of them under 10 years old--lined up to be inoculated with a brand-new vaccine that would protect them against the No. 1 public-health problem of the day: polio. They may, however, have received more in those shots than the intended vaccine. Scientific studies obtained by New York--some of them decades old--indicate that millions, if not tens of millions, of batches of the miracle Salk vaccine were infected by a tenacious virus that concealed itself within the renal cells of the rhesus and cynomolgus monkeys with which the vaccine was made. Scientists have been aware since the late fifties that this virus--later identified as Simian Virus 40, or simply SV40-caused deadly tumors in laboratory hamsters. But they are only now finding the footprints of SV40 in humans in rare lung, bone, and brain cancers. In research published in leading scientific journals, several labs have identified SV40's DNA, as well as some of the whole virus, in cancer tissue from people now suffering or already dead from incurable ependymomas, mesotheliomas, and osteosarcomas-the same types of rare tumors scientists had been able to produce by injecting concentrated doses of the virus into lab hamsters. One recent research project suggests a correlation between the geographic distribution of certain bone-cancer victims and the states--including New York-that received contaminated batches of the polio vaccine.
The implications are troubling. Though the exact way SV40 operates in human cells is still being studied, experts increasingly fear that the rogue monkey virus may play a direct role in causing cancer in some adults. "These are very provocative findings." says Dr. Philippe Chahinian, a leading oncologist at Mount Sinai Hospital and an expert in mesotheliomas. "We know that SV40 is implicated in cancers induced in the hamsters. Now we are seeing this agent might be implicated in the causation of certain human cancers as well.
The National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention are all aware of the possible link between cancer and the polio vaccine--though they warn that far more research is necessary before any firm conclusions can be drawn. "I am concerned that this may well be a discovery indicating a virus-induced cancer in humans," admits Dr. James Goedert, chief of Viral Epidemiology Branch at the National Cancer Institute. "The implications of that are pretty substantial given the connections with the polio vaccine. But we need to address the question of causality before we can come close to making any definitive statement."
As the medical Establishment pursues the problem in the labs, the issue is also headed toward the courts. Two enterprising lawyers, Donald MacLachlan and Robert Brownson, have spent almost two years investigating whether the government and drug companies could have acted sooner to prevent the spread of SV40 through the polio vaccine.
By 1995, the pair had come across troubling data the government had been aware of for decades. Tests of stored vaccine -- conducted by the National Cancer Institute in 1963 -- revealed that nineteen states, including New York, Pennsylvania, and most of New England, received heavily contaminated shipments of vaccine between May and July 1955. That translated into close to 4 million children being inoculated with high levels of SV40. An additional sixteen states and 3.7 million children received vaccine with lower levels.
Whether this 1955 pattern of contaminated shipments was maintained over the next eight years is hard to ascertain without the government's cooperation. But many prominent scientists agree that given the high number of SV40 carriers among the monkey population used to produce the vaccine, there is a strong probability that a significant number of the batches produced between April 1955 and March 1963 were tainted. So far, however, the Food and Drug Administration has not been forthcoming about how much of the vaccine is still stored for testing, although officials now say that a geographic analysis could be developed for the entire eight-year period.
"It's reasonable to think that those who received high levels [of SV40] run a greater risk, but how much is necessary to cause a problem is unclear," says Dr. Michele Carbone, a prominent researcher at Loyola University Medical Center who discovered the monkey virus in human mesotheliomas and osteosarcomas.
Needless to say, not everyone who was inoculated with an infected vaccine will ultimately develop cancer. However, the government has already recorded small but significant increases in some of the cancers in which SV40 is implicated. The National Institutes of Health, in fact, has begun a study on the mysterious rise in brain cancers, and an official acknowledged that SV40 will be part of that analysis.
"This is certainly a public-health concern," says Mount Sinai's Chahinian. "But while the numbers of these rare cancers are rising, it would be a very bold step to conclude that everyone who received the polio vaccine faces a risk of cancer. In fact, one would expect to see much greater numbers of cases by now if this virus were extremely dangerous."
Forty-three-year-old Kathryn Jordahl lives--and now expects to die--in a small town 70 miles south of Minneapolis. Minnesota, according to the 1955 data, was one of the states that received vaccine with high levels of SV40. A single mother of a 15-year-old girl, Jordahl first learned she had cancer after a hysterectomy in March 1995 at the Mayo Clinic. As she awoke from anesthesia, the doctors gently informed her that the mass in her uterus had turned out to be benign, but that during the operation they had found a rare and incurable cancer in the pleural tissue surrounding her lungs. Jordahl was shocked, but so, too, were the doctors. Such pleural mesotheliomas are found primarily in older men who have spent most of their working lives in plants manufacturing asbestos products.
"Your first thoughts when you hear the word cancer are overwhelming," Jordahl recalls. "And for it to be this rare type...You think, Am I going to survive? Is my child going to survive? I'm replaceable at my job, but as a single parent, I'm not replaceable at home, with my daughter."
Jordahl quizzed doctors about how this was possible. She hadn't been exposed to asbestos. She didn't even smoke (although this particular form of lung cancer has no known connection to cigarettes). Unwilling to give up hope, she set out looking for medical experts. As an employee-benefits consultant, she had good medical connections who led her to doctors at New York's Mount Sinai and Sloan Kettering known for their work in mesothelioma . Except for the possibility of very experimental surgery, their prognosis was discouraging.
Jordahl's search, however also turned up MacLachlan and Brownson, who by this time were already pursuing their SV40 investigation. The two lawyers, both in their early forties, are in some ways unlikely consumer crusaders. MacLachlan, who founded the occupational-and-environmental-health practice at the prominent New Jersey firm of Connell, Foley & Geiser, and Brownson, a partner in the Minneapolis firm Stich, Angell, Kreidler, Brownson & Ballou, usually spend their time preparing defenses for Fortune 500 clients.
What eventually put SV40 onto their radar screens was the increasing number of businesses being sued by consumers and employees suffering from pleural mesothelioma. Both MacLachlan and Brownson, who knew each other only professionally, were experts at defending corporate clients in this type of case. Separately, the two lawyers set out to determine the accuracy of such claims and why people with no apparent asbestos exposure were developing this form of cancer.
After months of study, the lawyers crossed paths and decided to join forces. By this time, each had already come across a seminal article published in the scientific journal Oncogene that discussed research conducted by a young Italian pathologist named Michele Carbone--then at the National Institutes of Health. Having already produced mesotheliomas in hamsters by injecting them with SV40, Carbone was now uncovering the same DNA from the virus in human mesotheliomas.
MacLachlan and Brownson persuaded Jordahl to have some tissue samples of her cancer sent to Carbone, who had moved to the University of Chicago. When Carbone tested Jordahl's tissue, he found what he had seen in 60 percent of his study samples: the distinctive DNA pattern of SV40. Unless one is an animal handler or a lab technician-or has spent time in the jungles of India or the Philippines-there is only one confirmed way to be exposed to SV40: the polio vaccine, often handed out free of charge by the government. Jordahl had no experience with monkeys; she did, according to medical records, receive three polio injections between 1956 and 1959. "I felt like I was in the middle of a science-fiction novel," she says of the revelation that her cancer could be connected to polio shots she received as a child.
To MacLachlan and Brownson, the larger question is what the government and pharmaceutical firms knew about SV40 and when they knew it. "Even with the limitations of scientific techniques, the scientists did know enough to be concerned, and clearly from some of their writings they were." insists MacLachlan. "They knew they had something very harmful on their hands. The government simply failed to act."
Carbone's work had also caught the attention of the Viral Epidemiology Branch of the National Cancer Institute. The VEB--specifically, a young scientist there named Howard Strickler--decided to see whether Carbone's work could be reproduced by a researcher of the branch's choosing. In memoranda obtained by New York, Strickler told superiors that if Carbone's results could not be duplicated, then further tests for the presence of SV40 in human cancers would not be necessary.
The scientist selected to lead the research effort for the Cancer Institute was Dr. Keerti Shah. Shah, who works at Johns Hopkins Hospital School of Hygiene and Public Health, is a respected scientist who earlier in his career had done work on SV40. In contrast to Carbone and other researchers, Shah failed to detect SV40 in his tests, and the VEB considered the case closed. Meanwhile, Carbone kept finding SV40 in cancers. In mid-1996, he teamed up with Robert Garcea of the University of Colorado and published a paper that documented the virus's presence in bone cancers known as osteosarcomas. To determine the presence of SV40, the two scientists employed an ultra-sensitive testing technique, admittedly somewhat prone to sample contamination, called polymerase chain reaction, or PCR. "To the best of what I could do, I distributed samples to different labs--in Italy, Colorado, NIH, University of Chicago," Carbone says. "The chance of contamination is reduced by the fact that so many labs were able to reproduce the same results."
In his study, Carbone uncovered a geographic distribution of his SV40-positive tissue-sample donors that turned out to mimic the limited data, released in 1963, on the destinations of contaminated polio-vaccine batches.
About the same time, the VEB started to get requests from "lay media"-initially from a London-based magazine, New Scientist, and its reporter Phyllida Brown. The reporter was pursuing a story about a paper that Carbone had presented earlier that summer at a meeting at the University of Turin. Although the study is not yet published, Carbone reported uncovering a possible mechanism by which SV40 could cause cancers--essentially by shutting down the healthy proteins that would otherwise prevent the growth of a tumor. If this is true, those with SV40 not only would be more susceptible to cancers when another factor, such as asbestos fibers, was present, but also might develop a cancer simply because of the presence of the virus. Brown's article was titled "Polio vaccine linked to cancer."
While declining to discuss this specific study until it has been peer-reviewed for publication, Carbone says. "You never get cancer because of one reason. A number of accidents happen before you get cancer. With SV40, there are enough intriguing coincidences that make it worth a much larger study."
Until recently, as a result of Shah's study, the VEB has all but ignored any possible link between cancer and the polio vaccine. After the publication of Carbone's paper, however, the agency asked him to participate in a joint NIH-funded project with Shah to detect SV40 in ependymomas. Though he is interested, Carbone will not sign on until he finds out whether the NIH --which is providing $50,000 for the project -- will agree to his conditions on how the research is to be carried out.
At the same time, other government scientists began investigating as well. This past September, Susan Devesa, a senior scientist at the National Cancer Institute, opened a project to determine whether there is a correlation between those people getting cancer and those who received contaminated polio vaccine. Her search will focus on the geographic distribution of the cancers. Meanwhile, the FDA and the NIH are also trying to organize a workshop on SV40, which will include experts such as Carbone. A specific date has not yet been chosen.
Even in light of current revelations, many scientists defend the decision to speed the Salk vaccine into production. A stealth virus that preyed most often upon young children, polio was the AIDS of the first half of the century. That slight summer fever that attacked a victim's nervous system and too frequently resulted in permanent paralysis or death made people drastically alter the way they lived their lives. Schools closed down when a few students fell ill; public gatherings of all kinds were canceled. Americans cut themselves off from their own neighbors, limiting outside contacts to avoid the unknown and potentially infected. During an outbreak in 1932, the employees of one Los Angeles hospital actually turned away patients with the disease for fear of contracting it themselves. Three years later, the entire city of Annapolis, Maryland, was put under quarantine.
The first major epidemic in the United States was recorded in New York City in 1916 - 9,023 cases and 2,448 deaths. Over the years, new and larger outbreaks in different cities in various regions of the country were reported as the peak June-through-September season rolled around. Then came the end of World War II and the baby boom, which created millions more potential targets for the virus, in 1952 -- the peak of the epidemic--close to 60,000 people contracted the disease. While only 3,000 would die, thousands more would be left paralyzed; many would spend the rest of their lives on crutches or in iron lungs. And the victims did not come from marginalized communities like gay men and drug users.
Indeed, from its first appearance, the virus had some very powerful enemies. President Franklin Roosevelt--crippled by the disease in 1921, when he was 39--made the search for a cure a top priority of his four administrations. There was no huge government-grant structure at the time to finance research, so Roosevelt used his own money and connections to create the National Foundation For Infantile Paralysis, which would later become the formidable March of Dimes. The many millions of dollars the foundation raised were handed out to those in search of a vaccine. Even so, progress came slowly.
Beginning in 1947, Jonas Salk, then an obscure microbiologist working at the University of Pittsburgh, had been attempting to develop a "killed" polio vaccine -- that is, one that depends on a dead polio virus injected into the body to fend off the actual disease by stimulating the creation of antibodies. It wasn't until 1953, however, that Salk was ready to test his vaccine on polio victims. A year later, 400,000 second-graders were used in an extensive field test. When the vaccine was officially licensed in 1955--with impressive speed --six companies were authorized to produce it in the United States: Eli Lilly, Parke Davis, Cutter Laboratories, Sharpe & Dome (later acquired by Merck), Wyeth, and Pittman-Moore.
Two weeks later, the first problems arose. On April 27, 1955, Surgeon General Leonard Scheele assailed one of the six companies, charging that its manufacturing lines had failed to kill the polio virus before the vaccine was disseminated. Cutter Labs in Berkeley, California, was ordered to halt production and recall batches of its vaccine. By the beginning of May, 44 so-called Polio Pioneers had contracted the disease from vaccine injections; ultimately, close to 70 would become infected and a handful would die. Top-level meetings of the nation's scientific elite were convened in Washington. On May 7, Scheele recommended the polio program be suspended entirely, and he instructed a team of scientists to personally inspect all the production facilities and techniques.
Yet eight days later, the vaccination program was back in full swing--though with extra pains taken to make sure the polio vaccine wouldn't cause polio. Salk, who would appear on the cover of Time that year, publicly criticized some of the manufacturers, claiming the problems stemmed not from the production protocols but from their execution.
Less than a month later, in June 1955, an article appeared in the University of Michigan Medical Bulletin by John Enders, a Harvard virologist who had won a Nobel Prize for his work on developing a polio vaccine. Enders suggested that it was indeed the technique for producing the vaccine that was flawed, calling it not "entirely satisfactory." He warned that beyond the risk of failing to kill the polio virus, the defective technique raised "the risk of including other agents whose presence may or may not be recognized." The "agents" to which Enders referred were the simian viruses -- there were far more than just SV40 -- and Enders was hardly the first to recognize them as possible contaminants.
Even as Enders issued his warning, scientists in the United States and Great Britain were beginning experiments to identify and understand simian viruses. On New Year's Eve, 1957, Dr. Maurice Hilleman joined Merck's laboratories. Soon after, he became the first person to name and describe an unknown virus from the monkey renal cells that turned out to be SV40. "At first, it was just a finding of one more virus, just another damn thing we had to screen for," recalls Hilleman, now 77, who still works at Merck. "Then we started to develop tumors in hamsters. My God, this was a great revelation."
Others had isolated the virus as well, but no action was taken by the government until months after the tumors developed. As early as 1960, some vaccine batches were tested and found to be contaminated with SV40. The public was never told. "I don't think anybody along the way was irresponsible," Hilleman says today. "It was important not to convey to the public [this] information, because you could start a panic. They had already had production problems with people getting polio. If you added to that the fact that they found live [monkey] virus in the vaccine, there would have been hysteria."
Janet Butel, a prominent researcher who chairs the Division of Molecular Virology at Baylor College of Medicine in Houston, Texas, seconds that judgment. "There have always been real questions about whether rodent tumor systems really predict what happens in humans. In hindsight, we had a piece of data that should have shown us something.... But at the time, the risk-benefit ratio of using the vaccine was huge." True enough, though in 1959 -- the same year scientists injected SV40 into hamsters and grew tumors -- a year's harvest of cranberries was held from the market because they were exposed to a pesticide that caused cancer in lab rats. Restrictions on cyclamates, nitrites, and saccharin were all based on experiments with lab animals and not actual tumors in humans. It is also not at all certain that stronger government action would have, in fact, disrupted production, since an oversupply of the vaccine was reported several times during the late fifties.
MacLachlan and Brownson believe the alleged link between cancer and the Salk vaccine will result in a slew of new cases against drug companies. They are still attempting to collect all the data on Jordahl to see whether she will make a good test case, although, based on her current diagnosis, she has less than a year to live. "As defense lawyers, we've seen so much litigation that doesn't pan out,'' says Brownson. "Every plaintiff attorney is on the search for the next asbestos. But this strikes me as something real."
Of the six drug companies contacted for this article, only two, Merck and Eli Lilly agreed to comment. "We certainly followed the drug-development standards of the day," says a Lilly spokeswoman. "It's not very fair to take today's drug development standards that are supported by technologies that no one even imagined in the fifties and try to apply them to something that happened 40 years ago." If indeed there does turn out to be a link between the polio vaccine and certain types of cancer, what can be done about it? Unfortunately, there are still no commercial tests to determine whether someone is carrying SV40. And the types of cancers the virus allegedly produces are not ones for which people are regularly screened. But Carbone and other scientists are attempting to develop a vaccine, and researchers are hopeful that studying the virus will at least lead to possible therapies for these rare cancers.
But is new exposure to SV40 still possible? A very recent article in the medical journal Cancer Research reported that scientists have detected SV40 in human semen. In addition to these findings, the incidence of suspect cancers in victims far too young to have received their inoculations during the years of contamination also suggests possible problems with the current polio vaccine. While an FDA official assured New York that the agency is "entirely confident" that the current vaccine -- all Americans now take the Sabin oral vaccine -- is SV40-free, the findings still remain unexplained. Scientists are not prone to public speculation, but some privately suggest that humans may have begun to transmit SV40 among one another in the same ways its original monkey hosts have done for generations--through some form of contact, sexual or otherwise.
Whatever the answer, it is clear that after decades of silence, the secret about SV40 and the polio vaccine is now out of the box. And if the government fails to take up the challenge, the legal community will not miss the opportunity. "The government had a 40-year head start; and it's still not addressing the issue," says MacLachlan. "The pharmaceutical industry isn't addressing it. So I guess it's up to the trial lawyers."
Sidebars and Photo Captions
Side Effect Scientists have long known that SV40 causes cancer in hamsters. Now a growing body of evidence indicates that it may cause carrier in humans as well.
Caption: A Nation gears up for War: Jonas Salk (left) triumphantly presents his polio vaccine in 1955. A few months later, schoolchildren across the country lined up for their shots. Millions of doses of the vaccine were rushed into distribution in that year alone.
Caption: "Foul Shot: Since 1955, Kathryn Jordahl has been suffering from a rare cancer linked to SV40, which contaminated many early doses of polio vaccine. Traces of the virus have been found in her tumor."
Caption: "Full-Court Press Attorneys Robert Brownson (left) and Donald MacLachlan are investigating current cancer cases that may be linked to the polio vaccine. Can the government and drug companies be liable?"
Caption:Monkey Business: According to Maurice Hilleman of Merck, who discovered SV40, the government kept the contamination of the vaccine secret to avoid public hysteria."
Map: The Hot Zone: In 1955, 9.9 million children were inoculated against polio. Of those, 3.94 million children in nineteen states, including New York, received batches of the vaccine highly tainted by SV40. In sixteen other states, 3.67 million received less-tainted batches." [Map by John Tomanio. Source: National Institutes Of Health. [Map shows High Levels of SV40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV40 present.]
Please note: I do not have graphics of the photosor map.
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