Vaccine Policy Debate : Polio War --Renewed Controversy
For Kay McNeary, life changed on a bus to Minneapolis.
Healthy when she boarded here in Seattle with her 2-month-old daughter, she was barely able to walk off the bus in Minneapolis. Polio was rendering her legs useless forever.
For Bruce Clark, life changed on a Memorial Day as he held his young niece. Days later, he was hospitalized in agony with the polio that would put a brace on his left leg and a cane in his hand.
And for Sheri Crawford, the mother of a 3-month-old girl, life changed in the middle of the night. By morning she would no longer be able to stand because of the polio that has made a wheelchair a permanent part of her existence.
Polio From Infants
McNeary, Clark and Crawford all got polio from the infants in their lives.
For in the United States today, the only cause of polio is the oral polio vaccine routinely administered to infants in society’s drive to rid the nation of the disease. In rare cases, the live viruses of which the vaccine is made are passed on to susceptible individuals who contract the disease.
Now, in increasing numbers, persons thus afflicted are fighting back with lawsuits of multimillion-dollar proportions. And so successful are they becoming that medical authorities fear that such litigation could someday provoke shortages in vaccine supply.
In the course of their legal battles, they are also reviving compelling questions about the nation’s polio vaccine policy. How those questions are answered could well determine how many persons unnecessarily contract polio.
Posing Moral Questions
These vaccine victims are also posing moral questions over free choice and society’s obligations to the few who bear the adverse side effects of vaccine programs designed to protect the many.
In the mathematics of medicine, McNeary, Crawford and Clark are abstract statistics come to life: the one in so many millions who randomly suffers the side effects of the oral polio vaccine.
Each year, almost all of the nation’s 3.6 million newborns are inoculated with oral polio vaccine, and each year, on average, 10 persons in the United States are stricken with paralytic polio. Some are young parents or others in the community whose own immunization was incomplete; others’ immunization histories are unknown. In at least one case here in Washington, a 30-year-old woman had received a complete series of vaccines before she was stricken. And some of the 10 are the infants themselves.
The paralysis in all 10, according to the U.S. Centers for Disease Control, is associated with the oral vaccine.
The paralysis arises paradoxically from what health officials see as the major advantage of the oral vaccine: It is composed of living polio viruses, which recipients spread to others. In this way, the immunity is passed on. In a handful of persons, however, those spreading viruses don’t immunize.
And a precious few infants themselves contract polio in a public health program designed, in large part, for the benefit of people around them.
For while an alternative vaccine without side effects--the Salk injected vaccine--is available to safely and effectively immunize individuals, public health authorities have preferred instead to routinely administer the oral vaccine in the belief that it better protects society as a whole--even if it causes some polio in the process.
But oral immunizations are frequently carried out without full warning to parents of the risks. The American Academy of Pediatrics, for example, recommends that pediatricians adopt no procedures that would decrease the likelihood of a child’s receiving oral polio vaccine.
“Even if you want the (injected) vaccine, you’ve got to fight a war to get it,” said Seattle attorney Daniel F. Sullivan, who won a $1.1-million jury verdict for McNeary and last December settled four other cases, including Clark’s and Crawford’s. “We’re asking people to sacrifice themselves for the good of the whole.”
‘No Fair Statistic’
“It’s one thing to sit back and say, ‘This is for the greater good, and sure, there will be one in 5 million who suffers,’ but that just falls apart when it happens to you,” said the 30-year-old Clark, who contracted polio in 1981. “There is no fair statistic when there is a totally effective alternative with no detrimental side effects.”
“They’re taking your life in their hands--and they don’t bother to tell you,” said an angry Sheri Crawford, 26, sitting in the wheelchair in the kitchen of her home in Pasco, Wash. She contracted polio in 1982 after her daughter’s second dose of oral vaccine.
“You know,” she said, “if I decided this thing on my own (between vaccines), I wouldn’t have much to complain about. But it wasn’t my decision. Here was a serious thing, and they didn’t tell me anything.
“They just said, ‘We’ll make this person a guinea pig.’ That’s what it’s like.”
“What he goes through on an everyday basis is what nobody could go through,” Louis Gibson said of his 7-year-old son, Jimmy, whose left leg has been impaired by polio from his first dose of oral vaccine in 1978. “He doesn’t believe he’s got a problem ‘cause it’s always been there.”
Push for Salk Vaccine
“You’re exposing recipients to the disease not for their own benefit, but for the benefit of someone who hasn’t been vaccinated,” said Dr. Darrell Salk, the 38-year-old son of vaccine developer Jonas Salk and now a pediatrician in Seattle. Darrell Salk’s own son has been immunized with the Salk vaccine, and Darrell Salk has become active in his father’s drive for greater use of injected polio vaccine, including helping lawyers with damage suits.
Today’s lawsuits in many ways are the recognition of a three-decade-old disagreement over which of the two polio vaccines is better. It is a dispute that has permanently divided the creators of the two vaccines, Jonas Salk and Albert Sabin. Sabin has never accepted findings that his living, oral vaccine causes polio.
Salk’s vaccine was the first of the two. Made of killed, or inactivated, polio viruses, it was first available for injection in 1955. The prior year, a stunning 18,000 cases of paralytic polio were recorded. For seven years, Salk’s was the sole polio vaccine, and it spared tens of thousands the nightmare of being permanently crippled, life in an iron lung, or death.
Chosen Polio Vaccine
In 1962, Sabin’s oral vaccine, with its live viruses administered on a sugar cube, became the nation’s chosen polio vaccine, even though Salk’s had dramatically reduced the instance of polio and even though some manufacturers thought the live virus was too dangerous to manufacture.
Medical authorities believed that the oral polio vaccine, widely known as OPV, offered several advantages for a mass immunization campaign: the ease and acceptance of oral administration as opposed to a painful shot, an expected longer-lasting immunity, the creation of immunity in the intestines to prevent the spread of wild viruses, and the spread of living, immunity-conferring viruses from the recipient to those around him.
By 1977, though, the federal government, concerned in part by the vaccine-caused polio and the potential liability of its makers, asked the Institute of Medicine of the National Academy of Sciences to review the two vaccines. At the time, only one-third of the polio cases in the United States from 1969 to 1976 were apparently caused by vaccine. Since then, non-vaccine-caused polio has virtually disappeared.
The Institute of Medicine concluded that “when properly used, either vaccine is highly effective both in preventing disease and in reducing circulation of wild virus in the community.”
It warned, though, that with only 60% of the population vaccinated against polio at the time, the unvaccinated 40% were at risk “if only (injected polio vaccine) is used.”
So the institute recommended that oral vaccine remain the principal vaccine for routine immunization of children. But it specifically added that injected vaccine be a choice for people “who, after being appropriately informed . . . still prefer (injected vaccine) and are prepared to make a commitment to the full schedule of vaccination.” That schedule includes four doses of vaccine, followed by periodic booster shots.
‘Provides Some Choice’
This approach, the institute concluded, “provides for some choice . . . when such a choice is not inconsistent with the public good, (which) is important in a society that values free choice.”
But today, Dr. Elena O. Nightingale, who was staff director of the 1977 study, says: “In theory, there is a choice. In practice, there isn’t. It’s only after these lawsuits that clinics are more careful (about warnings). It’s terrible to say that through litigation you sometimes get progress.”
“It is our position that it should be discussed,” Dr. Philip A. Brunell, chairman of the infectious diseases committee of the American Academy of Pediatrics, said of warnings to parents. But, he said, “I suspect it’s not being done in many cases.”
Moreover, the institute said: “It is essential that . . . an appropriate compensation system” should be established by the federal government for the victims of vaccine-associated polio.
Today, there is still no program, although a comprehensive compensation plan for all childhood vaccines could be enacted by Congress this year, according to the office of Rep. Henry A. Waxman (D-Los Angeles). Although Waxman, chairman of the House subcommittee on health and the environment, favors a compensation program, progress has been delayed until vaccine manufacturers supply data on the damages they have paid to vaccine victims.
Warnings to Parents
But the Institute of Medicine’s recommendation for better warnings to parents was adopted, and the federal government’s consent form now used in public immunization programs even suggests that unimmunized parents, or those whose immunity is unknown, can be immunized with injected vaccine before being exposed to their own children’s immunization with oral vaccine.
“If you did that routinely,” Brunell said, “you would never get the child in for oral polio vaccine,” possibly setting the stage for wild polio to occur. Thus, the academy urges pediatricians to adopt no procedures that would reduce the use of oral vaccine.
The lawsuits over polio took an extraordinary turn one year ago when a Kansas jury awarded $2 million in actual damages and $8 million in punitive damages to an Ottawa, Kan., farmer who contracted polio after the immunization of his daughter in 1975. Emil Johnson, now 64, almost died from the polio that has left his breathing permanently impaired.
“It was clear the (vaccine) company was aware of the risks and didn’t warn the doctors,” said Johnson’s lawyer, Gerald L. Michaud of Wichita. “When a jury understands this, that they were at risk and it could happen to them . . . “
Lederle Laboratories, the only manufacturer of oral polio vaccine in the United States, acknowledged that polio results from immunization, but said: “In producing vaccines which fully conform to standards promulgated and enforced by the federal government for use in immunization programs mandated by state governments, manufacturers are inappropriately penalized in having to bear the costs of no-fault injuries.”
25 to 30 Lawsuits
The company refused to disclose its losses to polio vaccine victims, but Darrell Salk said he knows of 25 to 30 lawsuits. In December, Lederle settled five Washington state cases, three of which totaled $1.615 million.
Such sums may well help to force a change in the nation’s polio vaccination policy--for the better or for the worse. If injected vaccine is as effective as oral vaccine and is not routinely used, the nation is sustaining 10 unnecessary cases of polio a year. If the injected vaccine is not so effective, a change--whether forced by litigation or not--may result in more cases of polio from wild viruses.
“If those (10) cases are preventable, they are worth working on,” said Nightingale, now a special adviser to the Carnegie Corp. in New York and an adjunct professor of pediatrics at Georgetown University Medical Center in Washington, D.C. “If the entire country switched to (injected) polio vaccine, these 10 might not happen. But you might start getting polio in a way we don’t know. There might be other problems.”
Since the Institute of Medicine study, said Dr. Alan Hinman, director of immunization for the Centers for Disease Control, “the situation is changed somewhat” because 98% of all school-age children have been immunized, thus cheapening the value of the spread effect that was so critical when immunization levels were lower. In addition, an improved, stronger version of the injected polio vaccine has been developed in Europe and is now being compared to oral vaccine in tests in the United States.
Hinman said that the nation’s polio vaccination policy will probably be addressed again in the coming year, although he expects a continued preference for oral vaccine. “The most likely thing that would precipitate a change in the near future is a legal crisis,” he said.
Stockpile of Vaccine
The possibility of a vaccine shortage caused by lawsuits is one reason the Centers for Disease Control has stockpiled a three-month supply of oral vaccine and is working toward a six-month supply, Hinman said.
Others believe that a change is in the offing. Dr. Frederick C. Robbins, who shared a Nobel Prize in 1954 for his basic research on polio virus and is now head of the Institute of Medicine, said: “I see no reason that, in the coming years, we shouldn’t be substituting killed vaccine for the live vaccine. It seems the logical thing to do. There is no doubt that, if you fully immunize your population, either vaccine will work.”
“There is a change in the wind,” Darrell Salk said. “It is unfortunate, but it is a fact the litigation has an influence on policy . . . and affects others’ considerations. Unfortunately, it has to be that way. It makes people stand up and listen. People should be aware there is an alternative. They do have a choice.”
For some, it’s too late. McNeary sits in her wheelchair in the kitchen of her home. On the wall is a photo of the bright-eyed, 39-year-old mother of two standing on her crutches and wearing leg braces.
“It’s grossly unfair that anybody should program somebody else’s decisions,” she said. “People should be given the choice and knowledge to make the choice.”
Of her own polio, contracted on Dec. 23, 1976, after her daughter’s first dose of oral vaccine, she said: “It has changed everything about me, my spiritual ideas, my physical condition, my environment, my family life. There wasn’t an aspect of me it didn’t change, and it was all drastic. I used to enjoy doing things, dancing, skiing, working on the lawn. Now I’m a spectator.
“You just lose out on a lot of life, and then you have the frustration of doing without.
“I’d like for them to be in my head for one week to see what they’ve done.”