Paul Offit on How We Could Lose the Modern Medical Marvel of Vaccines

Dr. Paul Offit has written an admirably clear account of why a legal case could mean the end of the modern medical marvel of vaccines (try BugMeNot if you need a log-in for the full article).

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.

Offit provides an overview of the consequences of a scare about pertussis vaccines in the UK in the 1970s.

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. [My emphases.]

The disincentives for remaining in the business of vaccine production were so strong that the US Government introduced the National Childhood Vaccine Injury Act in 1986. The Act was intended to deal with and compensate cases where children had been injured by vaccines, and to disallow those speculative claims for harm for which there was no epidemiological support (e.g., the purported connection between the vaccine for hepatitis B and Multiple Sclerosis). Despite the provisions of this Act, the potential profits did not justify the risk exposure. At the start of the 1980s, 18 companies made vaccines; by the close of the 1980s, only 4 were still producing vaccines.

Since that time, both in the UK and the US, there have been periodic shortages of vaccines: these have had consequences for the young, the elderly and those with compromised immune systems.

In the US, the companies that produce vaccines are about to find themselves in the dock, again.

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...

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 court has 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...

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.

I hope that Offit's jeremiad doesn't come true. If it were to come true, then truly we might be facing the prospect of the first generation of children to die before their parents.

Dr. Paul A. Offit, MD, is the chief of infectious diseases at the Children's Hospital of Philadelphia; he is 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: I have no direct or indirect, personal, financial, or professional connection to him. Likewise, I do not have a conflict of interest, personal, financial, professional, upstream or downstream connection to any pharmeceutical company.

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