On Vaccines, Immune to Reason

Recently, when visiting family in Philadelphia, my wife and I had the pleasure of seeing friends of ours and their baby daughter, Iona. While the proud papa and I swapped complaints about health care -- his as a father, mine as a policy wonk -- the topic of vaccines came up. Why, he asked, had companies ever put a mercury-based preservative (thimerosal) in vaccines and why did doctors administer those "dangerous" vaccines to children?

My friend is highly educated, very intelligent, and he naturally worries about anything that could affect the health of his daughter. But while many studies have failed to link thimerosal (phased-out of childhood vaccines by 2001) with developmental disorders like autism, he either hadn't heard of them or else just didn't trust them.

Sadly, too many parents have lost faith in vaccines. Partly, this is because of a "generation gap." In 1940, U.S. infant mortality rates stood at 40 deaths per 1,000 live births. Tens of thousands more children would go on to be killed or maimed by measles, polio and chicken pox. Today, infant mortality averages about 7 deaths per 1,000 live births, and those other diseases have been largely vanquished by vaccines. A childhood free of serious illness is now taken for granted.

When mysterious disorders like autism strike seemingly healthy children -- at about the same age when childhood vaccines are typically administered -- frustrated parents lash out at doctors and pharmaceutical companies. And today's vaccine inventors must contend with a powerful force that had yet to arise when Jonas Salk created his revolutionary polio vaccine -- mass litigation.

The birth of "liability without fault" in pharmaceutical litigation in 1958 -- captured in Dr. Paul Offit's riveting book The Cutter Incident -- set the dangerous precedent that vaccine companies would be held liable for side effects even when their products were made using the best available science and according to government regulations.

Vaccine litigation exploded in the 1980s. In 1983, Lederle estimated that its diphtheria, tetanus, and pertussis (DTP) vaccine sales were "dwarfed by [legal] claims by 200 to 1." In 1984, the first-ever million dollar vaccine jury verdict came down against a DTP vaccine manufacturer, later followed by a $10 million verdict against a polio vaccine manufacturer. Litigation took a deadly toll on vaccines; in 1957, there were 26 vaccine makers but, by the mid-1980s, there were just four.

In 1986, Congress intervened to create the Vaccine Injury Compensation Program (VICP), which substituted a science-based, administrative compensation system for injuries suffered from childhood vaccines (other vaccines have since been added). The program has brought the industry back from the brink, but thimerosal litigation is threatening to sink it yet again.

Since 2001, about 5,000 families have filed thimerosal-autism claims against VICP, forcing the program to lower its standards for evaluating claims. According to Newsweek, "autism plaintiffs are no longer required to file medical records with their claims, because VICP clerk's office does not have the space to accommodate such massive amounts of paper."

VICP claims have been consolidated into a handful of test cases before the U.S. Court of Federal Claims. In these "vaccine courts" claimants just have to meet a civil claims standard of "preponderance of evidence¿showing that causation is 'more likely than not.'" If the plaintiffs win, the VICP program -- with only $2.5 billion in reserves -- could be bankrupted.

Even if the claimants fail there, they can opt-out of the program and sue in civil court. According to UCLA law professor Stephen Sugarman, writing in the New England Journal of Medicine, VICP may not be much of a firewall against thimerosal litigation: "Not only do families with autistic children have support groups and organized lawyers behind them, but they also have the backing of several prominent senators and congressional representatives."

The debate over vaccine litigation has thus shifted from a presumption of innocence to a presumption of guilt. While the number of major studies that have failed to find any substantive link between vaccines and developmental disorders or autism is now in the double-digits (including a September 27th CDC study in the New England Journal), critics are effectively demanding that scientists prove that thimerosal does not cause illness -- an impossible standard.

The very success of vaccines has become their downfall. As Dr. Offit writes in Vaccinated, "When [vaccines] work, absolutely nothing happens¿Parents go on with their lives, not once thinking that their child was saved."

It is time to rescue vaccines from the witch hunts that go on when science fails to provide easy answers for complex diseases like autism. First, policymakers should end the opt-out option for VICP. If society is going to mandate vaccines for school children and encourage companies to invest in their development, companies must be shielded from the volatile passions of the jury box.

Second, and perhaps most importantly, policymakers must invest more in vaccine education, so that parents understand the benefits of vaccinations (along with their real, but very rare risks).

Vaccines may face an unappreciative audience within our own comfortable borders, but poor nations are in desperate need of them. Every year, for instance, 600,000 children die of rotavirus, a common childhood infection. Thankfully, in 2006 Merck got FDA approval for a vaccine to prevent it -- giving us 600,000 new reasons to reign in vaccine litigation.

This piece originally appeared in Washington Post

This piece originally appeared in The Washington Post