If you have been helped by the information on these pages, please considering donating some to help with my time to research - click above PayPal link. Thank you!
Much info on the history of these vaccines and the diseases
The True Story of Pertussis Vaccination: A Sordid Legacy by David Geier and Mark Geier
Other DTP, DTaP, DT information
More info here on DTaP (acellular)
More info here on DTP (whole cell)
More info here on Diphtheria portion
More info here on Pertussis portion
http://www.washingtonpost.com/wp-srv/WPlate/1998-08/30/015l-083098-idx.html
SHOTS IN THE DARK Did the DPT vaccine make some children catastrophically sick? The question is at the core of the majority of cases before a special federal vaccine court — and the rules for answering it have changed
By Arthur Allen Sunday, August 30, 1998; Page W10
“Mrs. Clements?” asks Special Master Laura Millman. “Would you like a glass of water?”
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 disability 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.
Millman, a sparky 52-year-old who exudes the blunt warmth of her native Bronx, has navigated this universe of grief for seven years, handling 474 cases so far. Her office, its walls hung with Albert Bierstadt prints of the American West, is one of a suite of rooms used by the special masters on the third floor of the National Press Building. She comes to work in tennis shoes, and eats her lunch of fruit and yogurt on the bench while hearing testimony. The suffering she encounters appears neither to paralyze nor numb her. “It’s extraordinary what people have to go through in life,” she says. “Tremendous tragedies affect these people, and they react heroically. They take care of these children for years and years though it’s tremendously difficult. When I have to refuse an award, it’s hard. But I know these children’s basic needs are going to be taken care of either way. It’s not like the ancient days, when they threw you off a cliff.”
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. “A seizure like this is by nature an encephalopathy,” Menkes responds. “Something was going on in this child’s brain that was bad.”
Robert J. Baumann, director of pediatric neurology at the University of Kentucky’s Chandler Medical Center, testifies for the government the next day. He disagrees. An EEG showed no abnormality after Andrew’s first seizure, Baumann says — ergo no encephalopathy, ergo DPT isn’t to blame. The debate over “encephalopathy” isn’t a semantic one. In Dorland’s Medical Dictionary, encephalopathy is defined as “any brain disease.” But in the 1995 regulations, encephalopathy is defined as, among other things, “a significantly decreased level of consciousness lasting for at least 24 hours.” Andrew Clements may have seemed groggy to his parents following his first seizure, but the medical record doesn’t show a decreased level of consciousness, Baumann says. As for Andrew’s 1995 catastrophe, he says, it was clearly brought on by an infection, not Andrew’s epilepsy.
The Clementses’ lawyer, Victor Harding, is sitting alone at the petitioner’s table, Michelle Clements having since flown home to Milwaukee to tend to her son. Harding has been in the personal injury business for more than two decades and has won million dollar judgments or settlements in nearly a dozen DPT cases. In 1987, he won a $15 million DPT award on behalf of a brain-damaged Wisconsin girl. One thing Harding did during that trial was subpoena documents indicating that drug companies were working on pertussis vaccines in the 1960s that appeared to be less toxic and just as effective as the whole-cell vaccine. The documents suggest the companies dropped them because they were not profitable enough to produce. “The jury hated the drug companies so bad when we got through with them that they would have awarded money no matter what,” Harding says.
He is convinced that the Clementses have a good case, and if they lose before Millman, or she offers them inadequate compensation, he says, he will help them sue the vaccine manufacturer in a regular court. But for now, he is pressing their claim here. Harding has a thick Milwaukee accent, and a penetrating, Columbo-esque air that probably goes over better in front of a jury than it does in front of Millman. On the second day of the Clements hearing, he seems to be trying her patience. She wants to get answers to a series of particular questions about whether Andrew Clements qualifies for compensation. Harding seems more intent on rattling the government’s witness: “Tell me, Dr. Baumann, is it possible, in your view, to prove that DPT causes encephalopathy?”
Baumann says that if it were not for the findings of the British study, he wouldn’t believe DPT could cause brain damage. “There is no biological proof this occurs.” Harding has his own, somewhat mystifying, theory to present: Think of the fuzzy pertussis bacteria as a peach, he says. And the vaccine production procedure as killing a bunch of peaches. The more peaches you have, the more poison juice, and the more juice, the more reactions. And the American vaccine has more killed bugs than the vaccine used in Britain, Harding says. The government attorney, Claudia Gangi, objects: “Petitioner’s counsel is acting as his own witness.” “Mr. Harding, where are we going?” Millman asks. “Killing a peach doesn’t do anything for me.”
But Harding presses on. “Isn’t it logical,” he asks Baumann, “to assume that if the U.S. vaccine has more bugs in it, it’s going to have more toxins and hurt more kids?” “Science isn’t based on logic,” Baumann snaps. “It’s based on experimental data.”
Michelle and Scott Clements, on the other hand, have experimental data of their own from caring for an utterly disabled child. To give Millman an idea of what they believe DPT has done to Andrew, they have videotaped their son’s daily routine, so she can view it in her office. They do this because, for all the adversarial qualities of the courtroom, if Millman is convinced DPT put Andrew where he is now, she will set up a fund to pay for his care — for his medicines and machinery and special schooling and all the other needs he will have as long as he lives. The tape is dated 8/27/97. It begins at 6 a.m. Michelle approaches Andrew’s hospital-type twin bed and gently shakes him awake. “Wake up, Drew bear. C’mon, sunshine.”
The Clementses live in a drab, three-bedroom, subsidized housing unit in northwest Milwaukee. The walls of Andrew’s room are covered with “101 Dalmatians” decals, and the dresser and chairs are full of stuffed animals in high-contrast red and black and white, the colors to which newborns respond. Andrew gradually comes awake, a subtle transformation in a semi-comatose child. His eyes flit back and forth, his nostrils flare and his mouth twitches into a smile. Although his motions are the tiny spasms of an infant, there is something rapt in Andrew’s body language in proximity to his mother’s voice. He unmistakably knows she’s there, and it clearly comforts him.
Talking all the while to her immobile child, Michelle grinds up his pills — antacids, muscle relaxants, stool softener, sodium fluoride for his teeth, potassium chloride for his blood pressure. She mixes them into a solution, takes a giant syringe and allows the liquid to drain through a plastic tube into Andrew’s stomach. Then she lowers the metal bed guard, scoops him up and carries him to the bath. Andrew is four feet tall and weighs 50 pounds. After the bath, Michelle carries him into her bedroom to put on his diaper and dress him for the day. Then comes breakfast — a can of PediaSure liquid formula syringed through the plastic tube. After breakfast, 20 minutes of nasal mist to break up congestion in Andrew’s lungs, since he can’t cough; tooth-brushing and drool-suctioning, since he can’t swallow. All the while she talks to him. “There’s a lot of letting him know you’re there. Andrew puts the biggest smiles on when you talk to him,” she says later.
“Sometimes he tries to talk back,” adds Scott Clements, 36. “He’s telling you how he feels, but you don’t understand him.” Government disability payments of about $400 a month provide Andrew Clements with his most basic needs, but they don’t begin to cover the real costs of caring for a severely disabled child. If they prevail in vaccine court and the money comes through, the Clementses hope to move into a house with tracking for a special wheelchair to move him around. A van with a ramp would be nice, too. It’s hard to think of what other things they may need, considering that doctors say Andrew could live to be 40. The Clementses are determined to keep him forever. “No one else can care for him the way we do,” Michelle says in an interview. “No one can love him the way we do.” The idea of putting him in a home, she says, is “sickening and disgusting.”
Nervous-system damage has left Andrew’s muscles taut. In January he had surgery to repair both hips. He returns to Children’s Hospital in Milwaukee some months later for a follow-up procedure. Michelle spends most of that week living in the hospital, sleeping on a small cot in Andrew’s room. Driving to the hospital one day, she talks about an anti-vaccine chat room on the Internet that she regularly checks in on, to communicate with other mothers whose children suffered problems after they were vaccinated. “We’re against the shots,” she says. “I’ll never let anyone I know immunize another person if I can help it.”
Sometimes, when she sees a pregnant woman, Michelle will go right up and urge her to get educated about the risks of vaccination. “Nobody told me my child could have seizures. If I had known, the heck I would have immunized him.” She has even started a support group for parents of vaccine-damaged children in Milwaukee. The women made little pins; imitation pearls and tiny angel’s wings glued to a white ribbon, like the red AIDS-awareness ribbons. “Pearl is for mothers, the angel’s wings are our children, and the white is for the purity of our kids before they got shots,” she says. She pulls into the Children’s parking lot, hangs a “Handicapped” sign on the windshield, and heads in.
In his third-floor room, Andrew looks as well as can be expected in his cirrcumstances. He’s in a body cast that extends from his feet to above his hips. His face is puffy, but the swelling has gone down some from the day before. Andrew whimpers mournfully as she tilts him to change his diapers — one inside the cast, the other outside. Michelle knows this wing of the hospital well. When she’s there, the nurses seem awed. They ask her permission before they do things. “Can we give him some ibuprofen now?” Liquid food goes into the tube. Then ibuprofen and morphine and Valium. Andrew cries a little, but his eyes are getting heavy. She pulls up his blanket. “You wonder what he’s thinking,” she says. “Maybe he’s feeling lonely.” Andrew is nestling into the pillow, drowsy and ready to sleep.
Once, he was a rambunctious boy, forever on the run along the paths and patches of grass at the red-brick housing complex where the Clementses live. He was a second child, always chasing after his older brother. He loved the bath — anytime they ran one, he’d come running to the tub, strip and jump in. One morning, when he was about 3, Andrew woke up and toddled down to the kitchen, turned on the oven and started trying to cook his own breakfast. The sound of eggs smashing on the floor roused Scott and Michelle out of bed. There are photo albums, which sometimes are too painful to look at. “We think about what he was like every day,” Michelle says. “You think to yourself, ‘Is there something I could do that would trigger something and bring him back?’ “ She strokes his brow. “He’s like a 1- or 2-month-old now. But the little things he does make a difference. Other people don’t notice, but we do.” Andrew smiles. It may be a coincidence.
The Vaccine Injury Compensation Program is sometimes cited as a model for other no-fault courts — offering a way, in theory at least, to resolve problems quickly, inexpensively and without confrontation. A bill moving through Congress now would create a $750 million fund to provide “compassionate payments” to hemophiliacs who got AIDS from contaminated blood supplies between 1982 and 1987. But many of those involved in the vaccine program say Congress should take a look at some of its problems: the backlog, the controversy over what constitutes an injury, the requirement that petitioners show at least $1,000 in medical costs, creating a Catch-22 for poor children, whose care — however inadequate — is covered by Medicaid or government disability payments.
The compensation fund has swelled to $1.2 billion. That being the case, some litigators wonder why it’s so hard to win a case for families whose misery is uncontestable, even if their cases are not scientifically airtight. “The fund is so huge,” says attorney Brian O’Connell of Boston, who has unsuccessfully represented a Massachusetts girl with a history of post-DPT seizures. “We had a pretty good case, the kid is very needy — so why couldn’t they give us some of the money?”
Public health officials have an answer for that: They don’t want payments made for injuries that were not certainly caused by the vaccine. There’s a larger issue, too. They want parents to immunize their children, and for that they want the record to show that vaccines are safe. “I’m not going to say that awarding too many people will undermine vaccine safety, but I look on the Internet, and I see that our statistics are taken out of context,” says Evans, the medical director of the compensation program. “And so it’s important that the table reflect what we think is really caused by the vaccines.”
Soon, whole-cell pertussis vaccine will be history, in the United States at least. The vaccine is disappearing from pediatricians’ offices, though not as quickly as some would like, and being replaced by safer, “acellular” vaccines. The new vaccines contain one or more elements of the pertussis bacteria, rather than the whole killed bug. Licensed for infants in 1996, the acellular shots are currently administered about two-thirds of the time. The acellular vaccines have been in use in Japan since 1981, after the Japanese had their own troubling experience with the whole-cell variety. Authorities there withdrew most of the whole-cell vaccine after two infants died following shots in the early 1970s; in response, coverage plunged from 80 percent of infants in 1974 to 10 percent in 1976. Then in 1979, Japan suffered a whooping cough epidemic that left 41 people dead. It was an incentive to speed up introduction of the new vaccine, which has proved to be just as effective and to have far milder side effects.
U.S. vaccine manufacturers and public health officials point to the Japanese epidemic and argue that it would have been a mistake to drop the whole-cell pertussis vaccine until the FDA had appropriately tested and approved the acellular variety. Pertussis continues to be a problem in the United States. In 1996, more than 7,500 cases of whooping cough were reported here, the most in three decades. Why that’s so is unclear. It may be that doctors are noticing more adult cases. And it just may be that some parents aren’t vaccinating their kids against pertussis because of the controversy.
Parents of affected children and their attorneys say that an effective acellular pertussis vaccine could have been introduced earlier in the United States if vaccine manufacturers hadn’t been protected from massive lawsuits by the compensation program. “The lawsuits were going to drive the manufacturers to come out with an acellular vaccine by making it too expensive for them to keep selling the whole-cell,” says Harding. “If they had come out with the acellular five years sooner, sure it would have cost a few cents more, but they wouldn’t have ended up with 30 or 40 or however many more brain-damaged kids.” Industry and public health officials counter that it is not as simple as that. It takes years and millions of dollars to bring a new product to market. “To get a new vaccine through the FDA, you have to prove that it’s safer than or as safe as the old vaccine,” says Pasteur Merieux Connaught’s Ruben, “and you have to prove the efficacy of the new vaccine in strict scientific terms. If something works, and is doing a pretty good job, you’re not going to spend all your time worrying about why it does what it does when you’ve got other things to worry about and you have to allocate your resources.”
Still, all sides now agree that the sooner the whole-cell vaccine disappears, the better. As Evans puts it, there may be limited scientific evidence to support the idea that the DPT shot can cause brain damage, “but when it happens to your child, there is an extremely strong feeling of association, and intuitively you’ll always feel it was caused by DPT. That’s a parent’s intuition, and there’s nothing that science can do about it.” Millman is uneasy about the Clements case. Under the old Vaccine Injury Table, it would have been easy to classify Andrew as having something called “residual seizure disorder” and automatically order compensation. In fact, the government offered the Clementses a $350,000 settlement in early 1995 — after Andrew’s epilepsy was diagnosed but before his crash — based on this classification. But the Clementses rejected the offer after Andrew took his turn for the worse and refiled their claim in the summer of 1995.
By then, the new regulations and the new injury table were in force. Now, the table no longer included such a category as residual seizure disorder, and not being on the table meant the Clementses would have to prove that DPT caused Andrew’s seizures. The question in the case now before Millman is, where is the proof? The fact that his seizures started 15 hours after the shot isn’t enough. Michelle Clements’s gut feeling isn’t enough. To award, Millman will have to accept Menkes’ theory about the blood-brain barrier — an unproven theory, albeit one that’s been around for decades. Even if she accepts that DPT caused the first seizure, in order to give the Clementses the kind of monetary award that would make a difference, she’d have to accept that Andrew’s full-blown collapse was caused by DPT-induced seizures, and not, as the government argues, by a grave infection of the blood. It’s a tricky case, Millman says in the course of the hearing, and she lets Harding know it.
“There’s a pretty good case for an appellate court to consider whether HHS has essentially gutted a statute that Congress passed,” she says. Basically, she’s encouraging him to challenge the constitutionality of the regulations under which she operates. She asks Harding to submit a formal brief on the issue — is there a separation-of-powers issue here? Has Congress essentially delegated away to HHS a legislative function? Harding, though, isn’t terribly interested. “I’m saying the whole system is screwed up,” he says in an interview at his Milwaukee office. And if Millman won’t compensate the Clementses, Harding will take the case to a more familiar stomping ground.
As for Michelle Clements, she has put her trust in Harding — and God. Andrew’s missfortune has awakened her political activism, but she keeps her indignation separate from her main work — to take care of the boy and hasten his return to some sort of life. It won’t be like on TV, she knows. Andrew isn’t going to suddenly sit up and walk. But she stays with him, talking to him, massaging his body every day, trying her best to keep alive a current that could turn him on again. “The doctors said he’d never smile, but he smiles,” she says. “They say he’s blind — but no one can see through his eyes. Some days he catches you as you walk through the doorway.” And someday he may talk again, she says. “We don’t know. All we can do is pray on it.”
On July 30, Millman finishes her deliberations: She dismisses the Clementses’ case, finding that under the new regulations, they failed to prove that DPT caused Andrew’s epilepsy. “The undersigned sympathizes with the Clements family for their situation and was very favorably impressed with Mrs. Clements as a witness and a mother,” she writes in her decision. “However, petitioners may prevail solely on the evidence they present, not on the sympathy they engender.” For the Clements family, the decision comes as a frustration, but not a shock. “Part of me wanted to cry,” Michelle says. “but it didn’t surprise me.” She and Scott are planning to continue their struggle in the legal system.
No longer on the website
Vaccine Bookstore
Highly recommended books