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At risk: vaccines

How a legal case could cripple one of modern medicine's greatest achievements

Correction: A June 3 article in the Ideas section, "At Risk: Vaccines," described Safe Minds as a group "now at the center" of litigation in a federal claims court over the link between autism and vaccines. Safe Minds is a Georgia-based nonprofit which funds research that will figure prominently in the court hearings. Safe Minds is not directly involved in the court cases.

No single medical advance has 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 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 from the face of the earth by vaccines. And we're not finished; vaccines stand as our only chance to prevent pandemic influenza, AIDS, and bioterror, and our best chance to prevent certain cancers.

Now, massive litigation could force companies to leave the vaccine business, threatening the future of one of medicine's greatest achievements. 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 likely take their claims that vaccines cause autism to civil court, where awards could be enormous.

"I don't want to see the drug companies go out of business," said David Kirby, author of the book "Evidence of Harm," speaking on Imus in the Morning in April 2005. But "we are looking at trillions and trillions of dollars of care for these people."

Predictions of massive awards, and dire warnings about the fate of vaccines, may seem over-dramatic. But vaccines were the first medical product that came close to being eliminated by lawsuits.

In 1974 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 from 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. During the next few years, 300,000 children in England were hospitalized and 70 killed by pertussis.

By the late 1970s fears of pertussis vaccine had spread to the United States. Before 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. Subsequent studies of hundreds of thousands of children showed that the risk of permanent brain damage was the same in children who had not received the vaccine as in those who had.

Facing further litigation, vaccine makers were poised to leave the business. 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 want to sue for damages caused by vaccines, they first have to go through a federal claims court.

This "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 had been disproved by epidemiological evidence -- such as those claiming 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, 18 companies made vaccines; by the end of the decade, 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 bloodstream infections, meningitis, and a common cause of pneumonia -- 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 they had 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 can cause autism. This theory has been advanced on television shows such as 60 Minutes, in popular magazines like Time and Newsweek, and on national radio programs such as Imus in the Morning. Most prominently, the mercury-causes-autism theory has been advanced by a parents advocacy group called Safe Minds.

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 whether children received the MMR vaccine or not, and five have shown that thimerosal-containing vaccines also do not 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 have 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 were a cause, the incidence of autism should have declined. Instead, the numbers have continued to increase. All of this evidence should have caused a quick dismissal of these cases. But it didn't, and now the courthas turned into a circus. The federal and civil litigation will likely take years to sort out.

Autism can be a heartbreaking 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 they did in the early 1980s, all American children will suffer, including those with autism. Then, we'll have only ourselves to blame.

Paul A. Offit, MD, is the chief of infectious diseases at the Children's Hospital of Philadelphia, the co-inventor of the rotavirus vaccine currently licensed in the United States, and the author of "Vaccinated: One Man's Quest to Defeat the World's Deadliest Diseases."