Story by Arthur Allen
The Washington Post
Sunday, Aug. 30, 1998
Shots in the Dark
It's 1:30 p.m. on a Thursday in a fifth-floor courtroom above Lafayette Square, and Michelle Clements has taken the stand in Clements v. Secretary of Health and Human Services. Clements, 30, a freckled, honey-complexioned woman wearing a purple blazer and black suede pants, will explain what has happened to her 6-year-old son, Andrew, who is home in Milwaukee with his dad. Andrew couldn't be with her. Andrew could no more board an airplane than fly to the moon. Neither can he walk or talk, or smell the flowers or watch the leaves tremble on the maple tree outside his window. Andrew cannot eat -- unless getting formula through a tube in the stomach can be called eating. This boy, who suffered catastrophic brain damage three years ago, lies in his bed all day, unaware of the life around him. How he got that way is why Michelle Clements is here.
Which is to say, in the Office of Special Masters, U.S. Court of Federal Claims, where Millman is adjudicating case #95-484V of the Vaccine Injury Compensation Program. A special master is a kind of judge assigned to sort through a group of related cases. In the windowless world they inhabit, Millman and the six other special masters working on the vaccine program are slowly sorting through evidence that stretches back to World War II. In each of the hundreds of cases they examine, the special masters are trying to determine whether a single vaccine shot caused a young life to end or spiral into ruin and, if so, how best to compensate the family. They are toiling in an area of law that tries to reconcile science and public health and compassion.
As she prepares to delve into what a vaccine called DPT may have done to Andrew Clements, Laura Millman begins by offering his mother a glass of water.
"No, thank you," says Clements. She wants to get on with it.
Behind her dark glasses and long, dark hair, she seems solidly composed. Her story begins with a nostalgic prelude, like most of the stories Millman hears. An uneventful pregnancy, joyful early months of motherhood that carry a tinge of guilty hindsight. After the prelude comes the night. Young brains seem to go haywire at night, when no one is watching. On that night -- August 6, 1992 -- Michelle Clements was watching television. Andrew and his older brother, Michael, were sleeping in the next room. Several hours earlier, during his six-month well-baby visit, Andrew had gotten his third DPT shot -- DPT being shorthand for the shot containing antigens that protect against diphtheria, pertussis and tetanus. Andrew had napped longer than usual, but hadn't seemed sick. Scott, his father, arrived home around midnight from his swing shift job at a pizza factory. He fixed himself a snack and "checked in on the boys," as always. But on that night, Scott heard Andrew "make a little noise." He rushed into the Clementses' bedroom with the boy lying limp in his arms. "My son looked pale and like he wasn't breathing," recalls Michelle Clements. "And so my husband called the ambulance."
So it began. The parents drove to the hospital, but Andrew wasn't there. They would learn that as the paramedics loaded him into the ambulance, his tiny body had gone into a clonic seizure -- a sickening jerking of the body that lasted half an hour. Ambulances won't move until a seizure patient is stabilized, so the EMS crew administered oxygen to Andrew on the sidewalk outside the Clementses' house while his parents waited at the hospital.
In the emergency room, they gave Andrew phenobarbital and Valium, and the seizure stopped. After two days of observation, he went home. "The doctors said he had had a convulsion," his mother recalls. "They said he probably wouldn't have another one."
"And you hoped that was the end of it?" Millman asks.
"Oh, I had hopes," she replies.
Andrew would suffer 80 more seizures over the next three years. How many visits to the hospital? Seventy, she thinks. She can't remember exactly. But it got so they would call 911, give the address, and the operator would say, "Seizure." Between the seizures, Andrew seemed happy enough, a mischievous boy with sweet brown eyes.
Then he fell off the edge.
On September 8, 1995, when Andrew was 31/2 years old, he had been ill for a few days, and his mother noticed that he seemed to be choking when she laid him down to change his diaper. She took him to the hospital. The nurses laid Andrew on his back and he choked. They sat him up and he had a severe seizure. His arms and legs spasmodically crimped and extended, as if he were lifting tiny weights. They laid him down again, then sat him up, and he had another seizure. Then another, and another. During seizures, people usually stop breathing.
"Andrew seized for four hours," his mother says.
Until now, she has been answering the court's questions in spare, simple sentences, her hands folded upon each other. At this recollection, though, she gasps and her hands fly up and cover her face. Head bowed over the wooden table, she quietly sobs.
But she needs to catch herself. The conclusion remains to be told. How his body was overwhelmed by an infection and his temperature rose to 108 degrees. How she blundered into a hospital room and caught a horrifying glimpse of her son bloated to what seemed like three times his normal size by the oxygen that doctors were pumping to his vital organs. She asked what was wrong and was told, "We don't know."
Michelle Clements asks for a glass of water.
Immunizations are a cornerstone of America's defense against infectious diseases. The hurts suffered when a nurse pokes a needle into a tiny arm or leg are typically nothing more than a swollen arm and a few tears. But on rare occasions, a vaccine ends up damaging a child's body rather than protecting it -- leaving the child learning-disabled, or in a wheelchair for life, or twisted like a pretzel in a crib. In the case of the DPT vaccine, such reactions precipitated a minor crisis in public confidence and, by and large, created the need for Laura Millman's court.
U.S. Public Health officials began recommending in the 1940s that DPT vaccines be used to protect children against diphtheria, pertussis (or whooping cough) and tetanus. The result, over the years, was a precipitous drop in cases of these diseases -- from hundreds of thousands a year for deadly diphtheria, for example, to just one case in 1996. But by the early 1980s questions began intensifying about the safety of the pertussis, or "P," component of the DPT shot. As doubts about the vaccine grew, they nearly caused a public health disaster.
Juries in a series of vaccine injury lawsuits saw documents indicating that the drug companies knew DPT carried some risk. The risk was tiny, but rarely acknowledged to the families who took their kids in for shots, which are widely required by schools or other institutions. DPT became something of a cause celebre, like nitrates in bacon or lead paint in public housing. Several juries awarded plaintiffs $5 million or more. Alarmed vaccine manufacturers either stopped production or jacked up their prices. By 1984, DPT vaccine rationing loomed, and the progress made to combat these diseases seemed threatened.
In response, Congress passed the 1986 National Childhood Vaccine Injury Act to protect the national immunization program -- and vaccine manufacturers -- from litigation, while providing a no-fault system to compensate children hurt by vaccines. All vaccines are covered by the act, but three-quarters of the complaints that it has dealt with are about DPT.
The Vaccine Injury Compensation Program is administered by the Department of Health and Human Services, with special masters like Laura Millman serving as independent adjudicators of cases that HHS does not concede outright. Awards for vaccine injuries are paid from a fund fed by a surcharge on each vaccine dose. The awards have ranged from a few hundred dollars for a scar, to $250,000 for a death, to several million for children requiring extensive lifetime care. The special masters can authorize payments for all "reasonably necessary" medical and other expenses provoked by a vaccine injury -- and provide funds for lost projected wages as well. If a family is unhappy with the special master's ruling, it can take its case to a regular court, but up to now this has rarely happened. At the outset, the compensation program seemed a resourceful way to finesse the tension between public health and individual justice: Justice would be swift and common-sensical; drug companies, shielded from liability, could produce the vaccines the public needed, and do research on new ones.
More than 1,100 children have been compensated since the program was established. And yet, the program probably raised expectations it could not meet. Because thousands of petitions initially poured into the claims court, the promise of speedy resolution failed. Some of the babies whose parents filed claims for DPT shots are of college age now, and have yet to get their day in court. Most controversially, not long ago HHS changed the rules under which it defends itself -- the government having assumed liability from vaccine manufacturers for claims stemming from DPT shots. And so, every week the vaccine program gets petitions from the families of children who died after a DPT shot, or were left physically or mentally damaged. But it rejects most of them. The children who come before Millman and her colleagues are damaged, all right, but not necessarily by DPT. Not under the new rules she must work with, anyway.
After college, Millman taught high school English in the Bronx for six years, then went to Fordham Law night school and graduated cum laude in 1976. She worked for the Department of Justice for 12 years, nine of them defending the government in the swine flu fiasco, in which 4,000 people claimed that shots against an elusive virus gave them a crippling nerve disease. Millman was appointed to her present job in 1991. She likes the challenge of puzzling through a medical mystery, and she likes public service. And not even the harshest critics of the compensation program will deny that it has brought relief to hundreds of families, paying out over $830 million since 1989.
But Millman's job has gotten harder since HHS changed the rules in 1995 (and refined them in 1997), limiting her ability to rule that a child was injured by DPT. The changes affected something called the Vaccine Injury Table, a table of common post-vaccine reactions that is the key element in determining whether a child will be compensated by the program. When a child presents symptoms from the table, the burden of proof falls on the government to show that some other cause was behind the injury. If the child's symptoms don't match the table's, on the other hand, the petitioners must prove the vaccine caused the injury. The changes adopted by HHS in March 1995 -- after a bitter and protracted dispute with representatives of families with vaccine-related claims -- reflect the agency's belief that DPT is only rarely to blame for the brain damage children have suffered after getting DPT shots. That meant that most cases presented to the program after that date no longer fit the table.
For all Millman knows, this is based on the best scientific evidence about DPT. But she and other special masters wonder whether the changes have made it impossible for them to carry out the program as Congress intended, namely, as "fair, simple and easy to administer." But what is fair in these cases? Does it mean giving families the benefit of the doubt when they say everything was fine until that shot? Or does it mean sticking, as close as possible in an inexact world, to the scientific evidence?
With the changes, the burden of proof in most cases now lies with the petitioners, and that is a tricky business, because proof is an elusive matter in ailments of the brain.
Under a microscope, the pertussis bacterium, Bordetella pertussis, is a hairy little bug. Its "fuzz" catches in the lungs and throat, where the germ emits poisons that cause swelling and a severe cough. The "whoop" of whooping cough comes from the desperate intake of breath between spasmodic, racking coughs. The disease is sometimes fatal in infants; even in older children, the frightening cough can make it hard to breathe or eat, and it can linger in the exhausted patient for up to three months.
The whole-cell pertussis vaccine, versions of which were introduced in the 1930s, is simply a solution of chemically killed pertussis bugs. Although it usually provides immunity against the ravages of the so-called wild variety, the whole-cell pertussis vaccine has always had more side effects than other vaccines.
According to the handout that the federal Centers for Disease Control requires pediatricians to provide parents, the complications from DPT shots are these: 1 in 100 DPT shots will provoke prolonged crying or high fever in an infant; 1 in 1,700 will cause a brief seizure or state of shock. Over the decades, several hundred million pertussis shots have been given around the world -- today, nearly 90 percent of American 2-year-olds have been immunized -- but there still is no agreement on the graver reactions to the vaccine. The literature has recorded hundreds of instances -- perhaps 1 in every 300,000 shots -- in which children died within a few days of a DPT shot, or suffered recurring seizures that brought on retardation or other chronic brain damage.
Scientists still don't understand how the vaccine causes reactions in children. In fact, they don't even know how it helps them. "In the strict scientific sense, we don't know how the pertussis vaccine works," says Frederick Ruben, director of clinical research at Pasteur Merieux Connaught, the largest producer of the DPT vaccine in the United States. "We're learning more and more about how vaccines work at the molecular level, but pertussis is a tough nut to crack. It's one of the more complicated germs."
When the compensation program began, nearly all of the children brought before the court with seizures or brain damage or other severe symptoms were recognized to be DPT-injured, and awarded compensation. But by 1995, experts in the field had come to a consensus that many of these symptoms had no unique clinical profile. In other words, the bad things that happened to some kids after getting a DPT shot also happened to kids who hadn't had the shot.
"When the rooster crows and the sun comes up, it doesn't mean that the rooster's crowing made the sun come up," says Gerald Fenichel, a professor of neurology at the Vanderbilt University School of Medicine, who played a key role in the 1995 HHS revisions. The only way to prove that DPT caused a particular syndrome was through epidemiological studies comparing incidence of that disease among inoculated and non-inoculated children. Such studies were inherently difficult to design, since nearly all children that doctors encounter are immunized.
The most reliable data seemed to come from a study published in Britain in 1981, with a follow-up in 1993. It looked at 941 kids hospitalized in Britain with brain damage, and found that 30 of them had gotten DPT a week or less before their first symptom. The result seemed to be more than a statistical accident. It led a U.S. Institute of Medicine committee to conclude in a 1994 study that "the balance of evidence is consistent with a causal relation between DPT" and brain damage -- but only brain damage as it was defined in the British study.
The British children had all been hospitalized with acute disease characterized by high fevers or uncontrolled seizures or brain swelling. For whatever reason, that wasn't so in many of the DPT cases coming before the vaccine court.
Many of these children, like Andrew Clements, would have a seizure after a DPT shot, then recover and play happily for a few weeks or months. Then they'd have another seizure, and another, until, like Andrew before his 1995 crisis, they were diagnosed as epileptics. In reviewing these cases, HHS's medical experts concluded that the first seizure's timing was either coincidental, or linked to the DPT vaccine only in that the shot had caused a fever that provoked the seizure. And since, they reasoned, any fever would have brought on the seizure, DPT was not to blame for the seizure disorder.
"It wasn't the pertussis vaccine that caused the problem, but rather an underlying problem that was unmasked by the reaction to the vaccine," says Fenichel.
"If you're going to posit that pertussis causes inflammation or some other damage, there should be a marker," adds Geoffrey Evans, the medical director of the Vaccine Injury Compensation Program and the author of the 1995 regulation changes. "And we haven't found one, which leads most people to think there's no biological cause other than triggering children who are genetically predisposed to seizures."
HHS conceded about a quarter of all DPT cases filed before the 1995 changes. Since the changes, however, it has conceded only nine out of 166, though some of these cases may be conceded after further review. If a case isn't conceded, it goes before a special master. Which is what happened in Andrew Clements's case. His seizures didn't meet the criteria of the revised Vaccine Injury Table, the government said, and it refused to concede that DPT caused his seizures. Andrew became an epileptic because of an underlying problem, according to the government. DPT was either the trigger or totally unrelated.
The revisions to the injury table were based largely on the recommendations of a 12-member committee of pediatric neurologists. The sole dissenter among the group was John Menkes, director of pediatric neurology at Cedars-Sinai Medical Center in Los Angeles. He believes that certain concentrated batches of pertussis vaccine can bridge the blood-brain barrier and crash a child's central nervous system. Menkes' theory, which is based on animal research, would provide a scientific explanation for hundreds of bad DPT reactions. There is no way to test the theory, and most neurologists dispute it, but this is what Menkes believes happened to young Andrew.
Menkes is speaking to the court by speakerphone from his Los Angeles office. The doctor has testified in more than a dozen cases before the vaccine court, always for the children. His exchanges with Millman on this day are arcane: "Are you alleging a pre-regs-change table injury?" Millman asks at one point.
"I'm alleging an on-table encephalopathy as of 1992," Menkes responds.
"If this kid had an encephalopathy, wouldn't he have been screaming?" Millman asks. "I'm used to kids who scream for hours like wounded panthers. They drive everybody crazy."
"An encephalopathy can occur without children screaming," Menkes says.
"If I say this wasn't an encephalopathy, would you still say Andrew suffered a DPT-induced seizure?" asks Millman.
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