Nineteen used to be Debbie Miller's lucky number. She was 19 when she met her husband, Bill. They married on the 19th of May. They bought their first home, a row house in Baltimore, on a 19th. Then, on the 19th of February, 1984, the first day the Millers were to spend in their brand-new Glen Burnie, Maryland, home, Debbie's luck ran out. For early that Sunday morning, Bill, in Debbie's words, "took ill."
Bill, 40, had been feeling rotten since Friday, when he called Debbie from his job as a radar technician at Westinghouse. Maybe Bill had caught the flu from their toddlers, Kristen and Michael, who had been hit by the bug a few weeks before. On Saturday morning, Bill went out and rented a U-Haul. Once at home, he plopped down on the couch, exhausted. But Bill didn't feel that bad. After waffling for a few minutes, the Millers elected to go ahead with the move. Debbie ended up doing most of the loading herself.
The next task that Saturday was to pick up the new refrigerator and washing machine they had stored in Debbie's parents' garage. Bill stood and watched as a few neighbors loaded the appliances onto the truck. Debbie's sister, seeing that Bill and Debbie needed help, pitched in. When the three got to the new house, Bill was feeling so bad that he walked to the bathroom in the master bedroom and sat on the floor.
Debbie and her sister began unloading the truck. Bill wanted to help, but every time he lifted his head, he said it felt like it was going to split wide open. Debbie and her sister continued with the unloading, even wrestling the new refrigerator up the steps, until they ran out of steam.
The three drove back to Debbie's parents, where Bill made a beeline for a bed. The others ordered takeout food. Bill slept. Debbie's mother suggested they stay the night.
Around five in the morning Bill called to Debbie, who was sleeping in another room, and asked for Tylenol and a cold drink. Bill's asthma also was bothering him, and he was so weak that he had to ask Debbie to help him with his inhaler. She returned to bed. A little while later he called to her again. She found him collapsed on the bathroom floor and helped him back to bed. As soon as Debbie climbed back into her bed, Bill called.
"I can't feel my left arm" Bill said. "Sit me up."
Debbie thought "stroke."
When Debbie lifted Bill his head slumped forward. She propped it up with her hands -- it stayed for a few seconds then fell again. Bill was scared and struggling to breathe. He was turning blue. Debbie called an ambulance.
At the emergency room, the physicians were more concerned about Bill's asthma than his numbness or drooping head. They gave him adrenaline and oxygen, and told Debbie he might have had a slight stroke. Eventually, one of the house doctors came in and insisted that Bill be moved to an intensive care unit.
Bill was worried that he wasnt going to make it. After moving to the ICU, he asked Debbie to call his parents. She left the room, spoke briefly with a doctor, and made the call. Five minutes later she was back by Bill's side and told him his parents weren't home. "He didn't acknowledge me" she remembers. "He was in a dead stare. I said, 'Bill. Bill?' He still didn't acknowledge me. His eyes didn't even come toward me." Debbie was asked to leave the room. She heard a doctor call Code Blue.
Bill suffered upper respiratory failure, and when Debbie saw him next he was on a respirator in an isolation area. He had tubes going down his throat so he couldn't speak. Debbie gave him a pencil and a pad of paper. He wrote, "What happened?" and then lost control of his pencil, his writing becoming illegible. Within moments he was completely paralyzed.
What had happened? It took months before anyone knew. They ran CAT scans and did a spinal tap. They transferred him to the University of Maryland Hospital in Baltimore and checked for encephalitis and meningitis. They ran test after test, and the results kept coming back negative. Many days they told Debbie that Bill wasn't going to make it through the night. His eyes turned yellow and bulged from his head, and to keep them from drying out the doctors stitched them shut. Finally, a doctor with a foreign accent came in who thought he recognized Bill's symptoms. He did some tests and consulted the Centers for Disease Control in Atlanta. The CDC confirmed his hunch: Bill Miller had paralytic poliomyelitis.
Although polio strikes an estimated 250,000 people in the world each year, only five to ten of those cases are in the United States, says the CDC. Given that America's polio epidemic racked up nearly 60,000 cases in 1952 alone, the handful of U.S. cases proves that our vaccination program works brilliantly.
But there's one glitch. Two polio vaccines are used in this country -- one is called "live," the other "killed" -- but since the mid-60s virtually everyone vaccinated in the U.S. has received the "live" one. And it is this live vaccine that causes most of the cases of polio in this country, say CDC researchers in the March 13 issue of the Journal of the American Medical Association (JAMA). Not only can the vaccine give the taker polio, it can also infect people who come in close contact with the recently vaccinated.
Bill Miller's four-month-old daughter, Kristen, received the vaccine less than two months before he was hospitalized.
According to the JAMA article, for every 2.6 million doses of the live polio vaccine distributed, one person contracts the disease. Debbie Miller and her lawyer believe Bill is that one in 2.6 million. Assume they're right. Unfortunate for Bill Miller, unfortunate for his family and friends. But no one doubts that the same vaccine keeps all but a few of us polio-free. No more fear of spring and summer, polio's favorite seasons. No more worries about children swimming in public pools. No more gangs of sweet-faced kids hobbling on crutches, rolling in wheelchairs, or entombed in iron lungs. A mighty argument in favor of this live vaccine. But there's one more wrinkle. The killed polio vaccine, when properly prepared, has never given anyone polio. In short, Bill Miller's polio could have been prevented.
Poliomyelitis, or polio, dates to the days of the pharaohs, but the first recorded epidemics came in the mid-1800s. Hard-hit cities like Stockholm, Oslo, and Lyons were befuddled when the disease began its assault. Americans probably first confronted the disease in 1894, the year the virus killed 18 children in Rutland County, Vermont, and paralyzed 114 others, the largest outbreak to that date.
It wasn't until 1908 that scientists isolated poliovirus, the agent that causes the disease. Poliovirus is shaped like a tiny soccer ball. Inside the ball, which is made of protein, is a single strand of RNA. Wild poliovirus enters the body through the mouth from droplets, such as spit, or from microscopic bits of fecal matter. (Bill Miller may have contracted polio from changing Kristen's diapers.)
After the virus enters the body it goes to the gut and reproduces. Normally, this viral infection is self-limiting, partly because the immune system produces antibodies to fight the virus. But in a small proportion of people, the virus travels through the blood and into the central nervous system, causing meningitis. Paralysis occurs only if the virus then gets into nerve cells. Scientists estimate that in an unvaccinated population, wild poliovirus paralyzes only 1 percent of the people it infects.
Because infants have their mother's antibodies for the first few months of life, they have temporary immunity to many diseases. When a "protected" baby meets the poliovirus, the baby will fight off the disease with its mother's antibodies, and the baby's immune system will also "learn" how to produce its own antibodies. If the baby meets the virus later in life, this "immunologic memory" will help the baby defeat the invader before it does any damage.
Sanitation seems to have played a role in catapulting polio from obscurity to plague status. Indoor plumbing, the germ theory, and other advances reduced the exposure of infants to wild poliovirus, creating more and more "susceptibles." By 1916, America's pool of susceptibles had so deepened that the poliovirus infected more than 27,000 Americans, killing 7,179.
Panic hit especially hard in New York City, where more than 2,000 died. People fled Manhattan, only to meet unwelcoming committees of gun-toters in the suburbs. Some hospitals refused to admit cases for fear of infecting others. Cats and dogs, mistakenly thought to be carriers, were impounded. Parents sealed their homes and refused to let their children out. Miracle cures abounded -- ox and frog blood, cedar shavings, radium water.
The polio vaccine that Kristen Miller took was made from a live poliovirus. Developed by Dr. Albert Sabin of the University of Cincinnati in the early 50s and first licensed in this country in 1961, the live vaccine -- also known as oral polio vaccine (OPV) -- is the vaccine of choice in most of the world.
The alternative to OPV is the killed, or inactivated, polio vaccine (IPV), developed at the University of Pittsburgh by Jonas Salk and first used in 1955. Many people distinguish it from OPV by the fact that IPV must be injected. Though it is no longer manufactured in the United States, it is still available -- at roughly ten times the cost of OPV. Some Scandinavian countries have relied on killed vaccine exclusively since its introduction.
The live polio vaccine is made of weakened or "attenuated" relatives of the three known types of wild poliovirus. Vaccine-associated cases occur when weakened virus reverts to a pathogenic-disease-causing-state.
Killed vaccine is made by inactivating or killing the RNA of the three wild polioviruses so the viruses cannot multiply. The virus's coat, the soccer ball, is left intact.
When the body meets either the killed or the live poliovirus, it responds as if it had met genuine wild virus and produces antibodies. The key to both vaccines is that they prime the body's immune system, "teaching" it how to successfully wage immunological warfare should the wild virus appear.
The live/killed debate has roiled scientists for half this century. There are logical, data-supported scientific arguments on both sides; the live vaccine didn't become this country's vaccine of choice because everybody agreed that it was the better of the two.
In 1921, the 39-year-old Franklin Delano Roosevelt was crippled by polio. Like Rock Hudson's AIDS, Roosevelt's condition changed the public's perception of the disease and became a catalyst for increased scientific research.
As president, Roosevelt staged charity balls on his birthday (the first in 1934) "to dance so that others may walk." More than 4,000 communities staged balls that first year, raising about $1 million. The money went to support a polio center in Warm Springs, Georgia, that Roosevelt had established eight years before, and to groups in the towns where the money was collected. City committees, in turn, gave the money to scientists and polio victims (health insurance was not yet common).
In 1935, two groups of researchers funded by the President's Birthday Ball Commission came up with vaccines -- one live and one killed -- and vaccinated about 17,000 children. The killed vaccine was later shown to be worthless, but not dangerous; the live vaccine killed six and paralyzed at least three others. Stung by the vaccine failures, criticized by Warm Springs's chief surgeon, charged with shamelessly politicizing polio, Roosevelt abandoned the annual birthday balls after the 1937 bash and announced the formation of a new nonpartisan group. The organization was named the National Foundation for Infantile Paralysis after the disease's popular name. Roosevelt said the National Foundation would "make every effort to ensure that every responsible research agency in the country is adequately financed to carry out investigations into the cause of infantile paralysis and the methods by which it may be prevented."
Under the direction of Roosevelt's former law partner Basil O'Connor, the National Foundation's first fundraiser was a radio blitz, again coinciding with Roosevelt's birthday. As the tale goes, comedian Eddie Cantor cooked up the idea of having radio stations donate time to ask for small contributions. "We could ask the people to send their dimes directly to the president at the White House," Cantor enthused. "Think what a thrill the people would get. . . . And we could call it the March of Dimes!" Two days after the appeal, only $17.50 had arrived at 1600 Pennsylvania. "You fellows have ruined the president," a White House aide complained.
A quarter of a million letters arrived during the following week, containing $1,823,045, including 2,680,000 dimes. Over the next 17 years, the National Foundation/March of Dimes would raise $295.2 million for polio research, becoming the largest voluntarily funded program of research ever directed at a specific infectious disease.
In 1948, the National Foundation spearheaded a research project to identify strains of poliovirus, a critical step in the development of an effective vaccine. Both Albert Sabin and Jonas Salk worked on the project. That year, the U.S. had 27,726 new cases of polio.
One of the biggest polio breakthroughs came the following year, when Harvard researcher John Enders (a National Foundation grantee) and his young associates Frederick Robbins and Thomas Weller discovered that poliovirus could be grown in nonnervous tissue, meaning scientists could grow the virus in test tubes rather than living animals. Immunologic studies that once required 100 monkeys could now be carried out by infecting one monkey, harvesting the replicated virus, and growing it in 100 test tubes. (The three later won the Nobel Prize for their work.) Also in 1949, Dr. Isabel Morgan of Johns Hopkins succeeded in immunizing monkeys with a killed virus vaccine.
That year, 42,033 Americans got polio.
Developing a vaccine for humans was the next step, but the scientific mood was cautious, partly because of the failure of the two vaccines in the 30s. Scientists urged the March of Dimes not to rush them or mislead the public into believing that a vaccine was just a shot away. But, as Allan Brandt wrote in the September 1979 Connecticut Medicine, "The dual role of the National Foundation -- philanthropic and scientific -- created tensions. The profusion of positive press releases, essential to fill the foundation's coffers, jeopardized scientific judgement." And the March of Dimes had competition.
Lederle Pharmaceuticals was also trying to produce a vaccine. In 1950, two Lederle researchers, Doctors Herald Cox and Hilary Koprowski, developed a live vaccine that contained weakened virus for one of the three types of polio. While a successful vaccine would need to be "trivalent" -- effective for all three types -- this was an exciting start. In the spirit of self-experimentation, Cox and Koprowski ate their vaccine.
That same year, Koprowski vaccinated 20 institutionalized children (volunteered by their parents), who subsequently developed antibodies without illness. Scientists branded Koprowski as reckless, but as the first vaccine administered to humans since the fiasco of the 30s, it showed that humans, like monkeys, responded to weakened poliovirus.
One of the paralyzed victims that year was Basil O'Connor's 30-year-old daughter. "When, in 1949, Dr. John Enders grew poliovirus, O'Connor sniffed victory," wrote Victor Cohn in the Minneapolis Star and Tribune in 1955, "and when in 1950 his daughter got polio, his quiet controlled frenzy was doubled. Now he wanted to be in on the kill."
That year, 33,300 Americans got polio.
Jonas Salk and Basil O'Connor became friends in 1951. Though they had met before, it was on the Queen Mary carrying them home from the Second International Poliomyelitis Congress that the bond became firm. Over the years, this friendship drew charges of cronyism -- which both men dismissed as untrue and irrelevant.
In 1951, 28,386 Americans got polio.
In 1952, with a grant from the National Foundation, Jonas Salk developed and tested a trivalent killed vaccine on 44 crippled children at a home in Pennsylvania. Their antibody levels were raised, making the trial a success, but many details had to be worked out before a vaccine would be ready for public distribution.
That year, 57,879 Americans got polio.
By 1953, Jonas Salk was one of the foremost researchers in polio. To allay the hysteria over polio and clear the confusion over the state of a polio vaccine, Jonas Salk addressed the nation in a radio broadcast, "The Scientist Speaks for Himself," in which he discussed the history of polio and current scientific progress. He stressed patience and the fact that he was only one of many researchers. His fame began.
In 1953, 35,592 Americans got polio.
The National Foundation conducted human tests in 1954 to evaluate what later became known, to Salk's chagrin, as the "Salk vaccine." The Polio Field Trials, as they were known, mobilized the country. There were 217 field trials in 44 states. Volunteers included 200,000 laypeople, 20,000 doctors and public health officials, 40,000 RNs, 14,000 school principals, and 50,000 teachers. Six-year-old Randy Kerr from Vienna, Virginia, was the first of 650,000 children to receive an injection (one-third were actually given a placebo). Another 1,180,000 children served as "observed controls." A Gallup Poll showed that more Americans knew about the Field Trials than knew the president's full name.
That year, 38,476 Americans got polio.
On April 12, 1955, the tenth anniversary of FDR's death, the head of the Field Trials announced that a "safe, effective, and potent" vaccine to combat polio had been found. Two hours later, the Department of Health, Education, and Welfare licensed the vaccine. As Richard Carter wrote in his 1965 book, Breakthrough: The Saga of Jonas Salk, "More than a scientific achievement, the vaccine was a folk victory, an occasion for pride and jubilation. A contagion of love swept the world. People observed moments of silence, rang bells, honked horns, blew factory whistles, fired salutes, kept their traffic lights red in brief periods of tribute, took the rest of the day off, closed their schools or convoked fervid assemblies therein, drank toasts, hugged children, attended church, smiled at strangers, forgave enemies." That evening, Salk appeared on See It Now with Edward R. Murrow. At a reception after the show Murrow told Salk, "Young man, a great tragedy has just befallen you." Salk asked him what he meant. Replied Murrow, "You've just lost your anonymity." Mass vaccinations began the next day.
Two weeks later, it was revealed that six newly vaccinated children had come down with polio. While they all might have acquired the disease prior to their vaccinations, it seemed unlikely. Furthermore, all six children had received the vaccine prepared by Cutter Laboratories, one of six pharmaceutical companies making the vaccine. The next day, Surgeon General Leonard A. Scheele asked Cutter to withdraw its vaccine. Fearing mass panic, Scheele assured the public that this was only a "safety precaution" and that there was "no cause for alarm." At the end of the day, two more cases, one fatal, were reported.
On May 7, with the cases of Cutter vaccine-related polio mounting, Scheele suspended all polio vaccinations. A few weeks later, live virus was found in a Cutter vaccine sample. Soon after, Scheele announced that vaccinations could be resumed, but the killed vaccine's credibility was marred. In the end, the Cutter incident left 150 children paralyzed and 11 dead. The incident also led to more stringent vaccine-manufacturing regulations that reduced the vaccine's potency.
In 1955, 28,985 Americans got polio.
But only 15,140 cases of polio were reported in 1956. In less than two years of use, Salk's killed vaccine had reduced the incidence of polio by more than 60 percent.
In 1957, the number of U.S. polio cases plunged to 5,485.
There were 5,787 cases of polio in 1958. One sign that the polio battle was won came when the March of Dimes organization switched its focus to birth defects.
Salk's progress to develop a vaccine was paralleled by that of Albert Sabin, who throughout the 50s continued to champion the live virus approach and even staged mass inoculations in foreign countries. By the end of 1959 over 15 million Soviets had taken Sabin's live virus vaccine. Sabin reported that his vaccine was 96-100 percent effective, and as the U.S. polio count rose again to 8,425 in 1959, the live vaccine argument was stoked.
Sabin and his supporters stressed that live polio vaccine passes through the vaccinee's feces, and once released into the environment, could immunize even those who did not take it. The live vaccine also created a lasting antibody response in the gut, preventing the spread of wild virus. These two effects combined to establish a "herd effect." So if it was true that polio was on the rise because people weren't taking the killed vaccine, then the live vaccine might afford better protection. In addition, more people might take the live vaccine because it could be swallowed rather than injected. Finally, live vaccine proponents argued that it would protect people longer.
By 1960, a Soviet medical expert boasted that 50 million people had been vaccinated with Sabin's live preparation and not one had come down with polio (a claim later shown to be spurious). At the Fifth International Poliomyelitis Congress, the Soviets were so confident of Sabin's live vaccine that they handed out candy laced with it.
Only 3,190 Americans got polio in 1960, and that number fell to 1,312 in 1961, the year Sabin's live vaccine was first licensed in America. The killed vaccine had reduced the number of cases 96.6 percent since the plague years of 1950-54.
Why was a new vaccine introduced when the old one was working so well? Richard Carter in Breakthrough says the American Medical Association embraced the new vaccine for political reasons -- physicians were taking a PR beating over their opposition to Medicare legislation, and Carter posits that the AMA thought mass inoculations with a new vaccine would make doctors look less "Scrooge-like." The mass inoculations, called "Sabin Sundays," took place later, but Medicare's birth was not aborted. Carter says other factors included Cold War competition and drug company influence.
The National Foundation, the U.S. Public Health Service, and Jonas Salk all fiercely fought the switch, saying that the plummeting number of polio cases showed that the killed vaccine was doing the job.
Today, the scientific debate is still smoldering. And Sabin and Salk are still striking sparks.
Sabin, 80, now lives in Washington, D.C., and is a senior medical science adviser at the National Institutes of Health's Fogarty International Center. Salk, 72, lives in La Jolla, California, where he is a distinguished professor in international health sciences at the Salk Institute for Biological Studies. Established by the March of Dimes in 1960, the Salk Institute has a staff of 500, including four Nobel laureates, that studies the brain, cancer, mental illness, aging, and birth defects. Salk calls the institute "an assault on the unreasonableness of life."
Over the years, the killed versus live vaccine debate has mutated into a match between Salk and Sabin. The story makes great copy: two learned, famous men bickering about a scientific principle, all in the name of mankind (neither has received polio-vaccine royalties). But the killed versus live issue is not a tale of two egos. As Salk says, "Making it into that has been a caricature." Killed versus live is actually a bramble of questions that are rooted in arguments of acceptable risk and free choice. Should some suffer so that others survive? What is a reasonable margin of error? Who decides what's best for the group? Doctors? Scientists? Government? Consumers?
In 1977 the Institute of Medicine, an arm of the National Academy of Sciences, reevaluated the two vaccines at the behest of the U.S. Public Health Service. "Workshop participants and committee members were unanimous in their view that IPV [killed] and OPV [live] are surprisingly comparable in their immunizing capacity, the persistence of immunity induced, and their demonstrated ability to reduce the incidence of poliomyelitis to the vanishing level. Their ability to eradicate paralytic poliomyelitis in the community appears limited mainly by the population's acceptance of vaccination." The committee recognized the "persistent number" of vaccine-associated paralytic polio cases as the live vaccine's main flaw, yet due to "practical and societal considerations," the committee recommended its continued use. The committee did stress that, as long as the public at large wasn't harmed, "in a society that values free choice" informed people should be able to choose between the two vaccines.
Dr. Elena O. Nightingale, staff director of the 1977 study, now works in Washington, D.C., as special adviser to the president of the Carnegie Corporation. She is also a clinical geneticist at the Georgetown University Medical Center. "I worked very hard to keep [the 1977 study] unpoliticized," says Nightingale, "and that is why neither Sabin nor Salk was invited. . . . In fact, it was because the Institute of Medicine is neutral that the U.S. Public Health Service asked us to conduct the study. That was precisely the reason."
A few years after the 1977 report, a new, ultrapotent killed vaccine was developed by Dutch researchers. The significance of the new vaccine was that one or two doses, rather than four or five, would confer lifelong immunity. (Booster doses have traditionally been recommended for both killed and live vaccines.) If viable, the new killed vaccine could easily be added to the one-shot diphtheria-pertussis-tetanus (DPT) vaccine, thereby making the "ease of administration" of the killed and live vaccines comparable.
This new vaccine is now in use in several countries. The Canadian Connaught Laboratories Ltd. and the French Institut Merieux, two of the vaccine's manufacturers, have applied for Food and Drug Administration approval to sell it in the United States. Dr. Gerald Quinnan, director of virology at the FDA, says he can't give a timetable as to when these vaccines will be licensed, but he says, "I would assume one of the more concentrated IPVs [killed vaccines] will be approved this year."
The NAS's Institute of Medicine has planned another evaluation of the killed and live vaccines. Dr. Frederick Robbins, the institute's chair and Nobel Prize winner for his polio work in the 40s, says, "My view of the matter is that this is a perfectly valid time to review this again."
Jonas Salk, for one, is anxious for the Institute of Medicine to conduct its review. "So long as oral polio vaccine is the vaccine of choice, it in effect excludes killed polio vaccine" says Salk. "What's needed is the justification that it's necessary to use [live vaccine] because [killed vaccine] is faulty. All things equal, it would be better to have not even one case."
Sabin believes that replacing the live polio vaccine at this point would be "a calamity." Many people in this country have never been vaccinated, he explains, insinuating that if the killed vaccine were reintroduced, there would be less protection via the herd effect and epidemics might return. (The CDC says that 98 percent of children entering U.S. schools have had a polio vaccination, and it estimates that 90 percent of Americans have protective antibodies.) What's more, says Sabin, "99.5 percent of the world is using oral polio vaccine and great results have been achieved." As far as paralytic polio associated with the live virus vaccine, Sabin says, "There are no vaccine-associated cases. The numbers are so small that the proof is absolutely without foundation." If the live versus killed issue is so cut-and-dried, why, then, hasn't the scientific world let it rest? "I'm sorry," says Sabin, "I'm not a psychiatrist."
Recent polio epidemics in the West African countries of Senegal and Gambia promise to intensify the killed/live debate.
Dr. Ralph Henderson, director of a World Health Organization (WHO) program to immunize all the world's children from polio and five other diseases by 1990, says Senegal and Gambia were using both the live and the new killed virus vaccines when poliovirus struck about 1,000 people. (A French-based international science group, not WHO, vaccinated the West Africans.) Says Henderson, "It was a serious blow for both [vaccines]." Henderson stresses that data from the outbreaks are still being evaluated. Failure of the new killed vaccine, for example, might have been related to the fact that the immunization team used a jet injector rather than traditional hypodermic syringes. "We continue to regard the two vaccines as more or less equally effective," says Henderson. WHO, however, has long made the live vaccine its vaccine of choice. "It's always a question of balancing risk versus benefit," says Henderson. He points out that vaccination rates, particularly in undeveloped countries, are well below 100 percent of the population. Therefore, says Henderson, "we think the advantage of the [live vaccine's] herd effect is an advantage that outweighs the risk." One other important concern of WHO is that on the world market the live vaccine is about ten times cheaper than the killed, a discrepancy Salk says would surely drop if the new killed vaccine were widely used.
The cost difference, oddly enough, may eventually lead to the live vaccine's demise in the U.S. While the killed vaccine is little used in this country, its cost per dose is now roughly half that of the live. The reason: people who get live-vaccine-associated polio are suing. This litigation has had such a strong effect that Henderson says, "Whether the decision [to switch from live to killed in the U.S.] will be made from cold-blooded analysis of the data or precipitated by liability concerns remains to be seen. The lawsuits may drive the decision more than the epidemiology."
Suing. It was the furthest thing from Debbie Miller's mind.
Every day she went to the hospital to see Bill. After about one month, Bill's facial muscles began to come back. The doctors unstitched his eyes. Although he couldn't speak, he communicated to Debbie through an alphabet board that allowed him to pick out letters and spell words by blinking or moving his facial muscles.
One of Bill's first messages was, "I know I am to die! Poor Debbie. What bout bills? Little more time."
After the Millers were convinced that Bill had caught polio from Kristen's vaccine, Bill's sister told Debbie she ought to think about suing. Debbie brought it up with Bill. "We talked it over back and forth and the situation was dropped" she recalls. "I never mentioned it to Bill again."
Then Debbie took Kristen to the pediatrician for her polio booster -- the same one who had given Kristen her first dose. A nurse handed Debbie two papers to sign, one about the dangers of DPT, the other about the dangers of the polio vaccine. "I took the papers down and I'm sitting there and I'm reading them," says Debbie. "I thought to myself, here Bill's laying up in the hospital with it, and now they're wanting me to sign papers before she has [the vaccine]. I sat there and I saw red. And that was it."
Debbie got in touch with Marc Moller, an attorney with Kreindler and Kreindler in New York City. Moller decided to sue Kristen's two pediatricians and Lederle Laboratories, the manufacturer of the live vaccine, for $10 million. "Doctors have been lulled into carelessness in the vaccine program," says Moller. "It unfortunately takes cases like this to remind them that carelessness can be very, very costly." As for Lederle, Moller says, "This kind of case should contribute to a momentum of polio policy consideration. And strong consideration should be given to the killed polio vaccine, which doesn't cause polio."
Each vial of vaccine that Lederle packages contains a warning to physicians that says, in effect, that the live vaccine is more dangerous to people who have suppressed immune systems. Bill had Netherton's syndrome, a congenital skin condition that's hard to miss as it causes red blotches on the face and hands, for which he was taking cortisone, a drug that suppresses the immune system. Debbie Miller alleges that Bill's immune system was suppressed at the time Kristen was given the vaccine, and that the doctors should have known. (Though Bill had been immunized for polio in the 50s, he apparently was part of the small proportion of the population that did not respond to the less potent killed vaccine. Moller says it was only luck that Bill didn't contract polio when Kristen's older brother, Michael, received his live vaccine.)
Even if the doctors couldn't deduce from looking at Bill that his immune system might be compromised, the suit states that they should have made an effort to determine the immune status of those around Kristen. Says Moller, "While doctors don't make drugs, this will remind them forcefully to be more cautious in circulating the use of the drug, rather than saying, 'Nothing's going to happen to my patient.'"
But there's another side. Says Dr. Helen Bowie, a pediatrician who retired last summer after 42 years of practice, "I've got sympathy for that pediatrician. It's very difficult to remember to take five minutes to explain vaccines."
Bowie says that even though she took time with all her patients and knew them well, she rarely told them about the risks of the vaccine. "I should feel guilty about that," she says. "It's the wrong attitude to take." But, as she says, "it's not a big deal about giving the vaccine. It's not a big part of the visit. It's unfortunate, but that's life in pediatric medicine. . . . Thank the Lord I never had any family member get polio." She says if she were practicing today, at the very least she would hand patients cards explaining the vaccines.
The Millers' suit is not the first against the manufacturer of a live polio vaccine. Litigation has had such a strong effect on the live vaccine's history, in fact, that since the late 70s Lederle has been the product's sole U.S. manufacturer. (Polio litigation is also credited with giving birth to the informed consent movement, whereby physicians educate patients and then have them sign waiver forms.) A recent Journal of Pediatrics article says physicians' fear of litigation may even reduce the number of vaccine-associated polio cases reported.
Lederle concedes that the live vaccine causes polio in rare cases. As stated in a 1985 Lederle information packet, "While OPV [live vaccine] is among the safest vaccine [sic] in use, scientists have recognized from the start that by its very nature, OPV can never be made perfectly safe, no matter how carefully manufactured ."
When asked about product safety, Martha Homma, a Lederle spokeswoman, references a recent report by the U.S. Public Health Service's Immunization Practices Advisory Committee and the position of the American Academy of Pediatrics. "It's really those experts who decide" says Homma. "I know how Salk would love to have his vaccine back" she adds.
Pediatrician Darrell Salk, an associate professor at the University of Washington Medical School and one of Jonas's three children, has written extensively on the killed versus live issue. Moller retained Darrell as an expert witness in the Miller case. Lederle won't state how many times it's been socked with live vaccine suits, but Darrell -- who has been involved with vaccine research for the past decade -- says he's heard of more than three dozen cases. In one Kansas case, later overturned, a jury awarded the plaintiff $10 million. The lawyers are considering another appeal.
Says Darrell, "In my opinion, the [vaccine] recommendations should be changed to reflect the current licensing situation; that is, the two vaccines are available, these are the ways the vaccines behave, and it's up to the physician and the patient to choose which vaccine to use. That's the way the recommendations read in the 1960s." Darrell says phraseology like "vaccine of choice" did not begin to appear until the mid to late 70s, after lawsuits began to sprout.
"The principal reason stated for the use of live poliovirus vaccine is not for any benefit to the recipient, but for theoretical benefit to others who might be immunized, without their knowledge or consent, because the virus spreads to them from somebody else" he says. Darrell says he thinks eventually this country will return to killed poliovirus vaccine. "It's just a matter of timing."
The Washington Star published an article in 1981 by Bernard Reis, a former Vassar College professor who had contracted polio -- presumably from the live vaccine his infant son received. The article, "Vaccine Made Life Hell in Slow Motion," detailed how polio ruined his marriage, left him broke in a New York City welfare hotel, and how the drug company (Pfizer) scooted free on the statute of limitations. "When I consider the ways in which the Sabin oral polio vaccine has totally destroyed my life, two questions occur to me," wrote Reis. "How many more tragedies such as mine must there be before the scientific community in this country comes to its senses? And why has this supposedly compassionate nation so icily turned its back on the sad victims of this lethal product?"
In May of 1984, Bob Murphy, one of Bill Miller's coworkers at Westinghouse, brought him a specially rigged Commodore 64. The computer was attached to a pair of eyeglass frames that had a special sensor in one lens that Bill could activate by blinking. Bill began to communicate frequently. "I feel so bad, it's already been four months," he said to Debbie June 17. "You have to remember that there's not a darn thing I can do. I wish I could be with you and help. I wish I could have a few pieces of ice."
"Nothing ever happened to his mind or his feelings," remembers Debbie. "He felt pain -- he was aware of needles. He was in constant misery, in agony all the time. He itched, he couldn't scratch. His mind just laid there and worked about the children, about me."
On July 4, Bill said, "I really had a bad night. I'm so fed up with everything I don't mean it the way you think." Less than two weeks later he asked, "How long are we going to live like this?"
Bill was fed through a stomach tube, which didn't work out well. Since he had no stomach muscles to speak of, his stomach couldn't hold the tube. The hole kept growing larger, Debbie recalls, and the tube kept sliding out. Bill got vicious bedsores on his rear and back. When his head slid off the pillow it would just hang until someone noticed.
"This whole thing is getting more f???ed as we go on and I cannot do a damn thing about it" he wrote August 12. "I will love you and our two beautiful children with my last breath." The next day he wrote, "I'm scared, I wish God would do something, I'm afraid to die because I can't breathe without machine."
"To hold the children, that was his main fear," says Debbie. "Even when I took them up, he couldn't hold them. I would prop the children in his lap and wrap his arm around them. But he couldn't hug them, kiss them."
Employees at Westinghouse took up a collection and bought Bill a TV. Debbie later bought a VCR, and then every night before she went to the hospital she'd stop and rent a movie for the two of them to watch.
August 17th Bill wrote to his parents, "Today makes 1/2 year -- 180 counted days. The staff tells me chances are not any or much of ever changing -- for as long as my present health lets me -- HA! I guess I won't be home for Christmas with Debbie, Michael, and Kristen. Thanks to God -- I don't even know but thanks anyway. Deb and I were blessed but it was short lived for me!"
August 27: "Debbie this is the hardest week I've had. Today they placed the Hickman catheter in. I'm getting fed up. Do you think God will let me come home? I don't think we'll ever get back to normal. I haven't given in yet. Also, I haven't really cried. I'm trying so hard to get back home to you and our kids."
September 12: "I miss giving Michael a bath and I never had a chance to give Kristen one. Michael said to me, 'Daddy go to Mikie's house?'"
September 14: "My life is gone that's the point to make. I hope I get to see our house. I don't want Michael and Kristen to forget me. What's going to happen to us? I wish I was dead, I can't take much more -- I'm sorry I didn't mean what I said."
September 29: "1 feel like I've been committed. I have to depend on someone for everything everything. There isn't anything I can do because I can't move my hands. Wipe my nose, I have no control of it. I hope you have all my things, key and wallet etc. Not talking is so hard. I'm sorry if I make it hard on you."
Bill started to become confused. "I'll play a game to prove my love for you," he wrote October 2. "Did I beat you? Why am I here? I've got POLIO caught it from Kristen's vaccine. I was paralyzed now I'm not. I can move everything. Do you need any money? Get your pocket-book, open it and leave it on the bed."
Even though Bill was put in special beds, his bedsores grew uglier and more painful, especially one on the back of his head. He began to talk to an imaginary friend in the mirror.
"We thought maybe he had picked up a friend in the mirror to pick up that time that I wasn't there or the nurse wasn't there by the bedside," says Debbie. He went in and out of comas. He started bleeding internally. His heart became enlarged, then his liver. "Every time the doctors said he wasn't going to make it, he pulled through," Debbie says. "For what reason? The doctors were totally stumped."
Debbie got special permission to be with Bill New Year's Eve, 1985. Bill was so unaware of what was happening Debbie left before midnight.
January 15, Debbie went on her usual evening visit. She started cleaning up Bill's dry skin, and then a nurse came by and said she was going to bathe him that night. Debbie left. She received a call early the next morning from the doctor. Bill had had a heart attack. "By the time I got there he had already passed away," says Debbie. "They tried. I think he had just given out." It was January 16th, nearly 11 months after Bill had entered the hospital.
On the 19th, Debbie buried Bill.
Art accompanying story in printed newspaper (not available in this archive): illustration/Will Northerner; photos/courtesy March of Dimes Birth Defects Foundation, courtesy Albert Sabin.