The Omnibus Autism Hearing - Op-ed

Parents of autistic children are about to have their day in court. On June 11, in an unprecedented action before a federal claims court, lawyers for 4,800 autistic children will argue that vaccines caused autism. If successful, these claims could exhaust the pool of money currently set aside to compensate children who have been hurt by vaccines. Further, lawyers will then be encouraged to take their claims that vaccines caused autism to civil court, where awards could be enormous. “We need to figure out how we're going to compensate these families; how we're going to take care of these children; how we're going to remove the burden from states, because right now they're footing the bill for everything,” said David Kirby, author of the book "Evidence of Harm." “I don't want to see the drug companies go out of business. I don't think anyone wants that. [But] we are looking at trillions and trillions of dollars of care for these people.” Massive litigation against vaccines threatens one of the greatest achievements of modern medicine.

During the twentieth century, the lifespan of Americans increased by 30 years. Some of the increase was caused by advances such as antibiotics, purified drinking water, sanitation, safer workplaces, better nutrition, safer foods, seatbelts, and a decline in smoking. But no single medical advance had a greater impact on human health than vaccines. Before vaccines, Americans could expect that every year measles would infect four million children and kill 3,000; diphtheria would kill 15,000 people, mostly teenagers; rubella (German measles) would cause 20,000 babies to be born blind, deaf, or mentally retarded; pertussis would kill 8,000 children, most of whom were less than one year old; and polio would permanently paralyze 15,000 children and kill 1,000. Because of vaccines all of these diseases have been completely or virtually eliminated from the United States. Smallpox — a disease estimated to have killed 500 million people — was eradicated by vaccines. And we're not finished; vaccines stand as our only chance to prevent pandemic influenza, AIDS, and bioterror.

Although dire predictions about the fate of vaccines may seem overly dramatic, vaccines were the first medical product almost completely eliminated by lawsuits.

In the mid-1970s a British researcher named John Wilson published a paper claiming that the whooping cough (pertussis) vaccine caused permanent brain damage. Wilson reported the stories of 22 children who suffered epilepsy or mental retardation following vaccination. The British media hailed Wilson's report as fact and the percentage of children immunized dropped from 80 to 30. As a consequence, 300,000 children were hospitalized and 70 killed by pertussis.

Fears of pertussis vaccine spread to the United States. In front of jurors persuaded more by emotional appeals than by science, lawyers successfully claimed that the pertussis vaccine caused Sudden Infant Death Syndrome (later found to be associated with sleep position), Reye's Syndrome (later found to be associated with aspirin), unexplained coma, paralysis, mental retardation, and epilepsy. Seven companies stopped making the vaccine; within a few years only one, Lederle Laboratories, remained. Lederle was punished for its persistence. In 1986 a jury awarded $1.13 million to parents claiming that Lederle's pertussis vaccine had paralyzed their son — an award that was more than half of the annual sales of the vaccine. Vaccine makers were poised to leave the business. Ironically, subsequent studies of hundreds of thousands of children showed that the risk of permanent brain damage was the same in children who had or hadn't received the vaccine.

To save vaccines, the federal government stepped in, creating in 1986 the National Childhood Vaccine Injury Act. Designed to put an end to unfounded lawsuits, the Act included the Vaccine Injury Compensation Program. Now, if parents wanted to sue for damages caused by vaccines, they would first have to go through a federal claims court. Vaccine court established a list of compensable injuries and lessened frivolous litigation. Children actually hurt by vaccines, such as those paralyzed by the oral polio vaccine or those with severe allergic reactions to egg proteins in the influenza vaccine, were compensated quickly, generously and fairly. On the other hand, people whose claims were disproven by epidemiological evidence, such as those claiming that the Haemophilus influenzae type B vaccine caused diabetes or that the hepatitis B vaccine caused multiple sclerosis, weren't compensated. The bleeding stopped. Unfortunately, the legacy of the pertussis litigation remains.

Many pharmaceutical companies that abandoned vaccines never came back. At the beginning of the 1980s, eighteen companies made vaccines; by the end, only four were left. The infrastructure to make vaccines became tenuous and vaccine shortages became commonplace. For example, in 1998, the tetanus vaccine was in such short supply that its use was restricted to emergency rooms. Beginning in 2000, a pneumococcal vaccine for children, designed to prevent a common cause of pneumonia, bloodstream infections, and meningitis, was available only intermittently; parents could only hope that their children weren't among the thousands permanently harmed or killed every year by pneumococcus. Between 2003 and 2004 an influenza epidemic created a demand that dramatically exceeded supply; more than 150 children died that year from influenza. Since 1996 severe shortages have occurred for 10 of the 16 vaccines routinely given to children and adolescents. All of these shortages resulted in a delay in getting vaccines and some children never got the vaccines that they missed.

Now, vaccine makers are again threatened. Lawyers will argue that either the measles-mumps-rubella (MMR) vaccine or a mercury-containing preservative (thimerosal) in vaccines or the combination of the two caused autism. This theory has been advanced on television shows such as 60 Minutes, in popular magazines such as Time and Newsweek, and on national radio programs such as Imus in the Morning. Most prominently, the mercury-caused-autism theory has been advanced by a parents advocacy group called Safe Minds — a group now at the center of the litigation.

Certainly there is plenty of evidence to refute the notion that vaccines cause autism. Fourteen epidemiological studies have shown that the risk of autism is the same in children who received or didn't receive the MMR vaccine and five have shown that thimerosal-containing vaccines also don't cause autism. Further, although large quantities of mercury are clearly toxic to the brain, autism isn't a consequence of mercury poisoning; large, single-source mercury exposures in Minamata Bay and Iraq caused seizures, mental retardation, and speech delay, but not autism.

Finally, vaccine makers removed thimerosal from vaccines routinely given to young infants about six years ago; if thimerosal was a cause, the incidence of autism should have declined. Instead, the numbers continue to increase. All of this evidence should have caused a quick dismissal of these cases. But it didn't and now the court, overwhelmed by massive litigation, has turned into a circus.

Autism can be a heart-breaking disorder, often draining parents emotionally and financially. Although many promising genetic, epidemiological, and biological studies have been published during the past few years, autism remains a disorder without a known cause or cure. This has been enormously frustrating for parents. It would be nice if there were someone or something to blame. We could blame the government and use the federal vaccine compensation program to pay for care. Or we could blame vaccine makers, and get them to pay in civil court. But if vaccine makers — faced with large awards for a problem that wasn't their fault — make the same decisions that they did in the early 1980s, all American children will suffer, including those with autism. Then, we'll have only ourselves to blame.