Medical Examiner

The Vaccine Fairy

How to make lawsuits disappear—and how not to.

Americans are apt to forget public-health lessons quickly, a tendency that is reflected in two decisions—one foolish, the other wise—this month. Last week, in the votes approving the omnibus defense appropriations bills, Congress gave sweeping liability protection to companies that make vaccines and drugs for pandemic flu or bioterrorist attacks. The legislation offers scant protection to the people who consume the vaccines and drugs, and if it stands, it could sabotage the vaccination system it is intended to protect. In the second, more sensible decision, on Dec. 14 an FDA advisory committee voted 9-0 to license a vaccine against rotavirus, a microbial invader that causes the hospitalization of up to 70,000 babies each year in the United States.

The rotavirus vote was a milestone in a new era of vaccine safety that began in 1986, when Congress passed the National Vaccine Injury Compensation Program. The act created a special no-fault court for families of children hurt by vaccines. It also expanded government surveillance for vaccine-related injuries. In July 1999, the CDC’s safety sleuths detected a 20-fold increase in the risk of contracting an intestinal disorder called intussusception following vaccination with RotaShield, a rotavirus vaccine made by Wyeth. The problem made it impossible to market the vaccine in the United States. It also effectively nixed the delivery of RotaShield to countries in Africa, Latin America, and Asia, although the disease kills as many as 500,000 children in poor countries each year, mostly through dehydration—far more than RotaShield would have likely harmed. “If they won’t use it on Park Avenue,” a foreign health minister is reported to have said, “we don’t want it here.”

Merck had its own ROTATEQ vaccine in development in 1999. In light of the RotaShield mess,the FDA sent Merck back to the clinic, ordering it to conduct an enormous trial—estimated to have cost $800 million—to prove that its rotavirus vaccine was safe. A total of 72,000 children were enrolled in 11 countries, mostly in the United States and Finland. (Half got a saltwater placebo solution.) The company’s chickenpox vaccine, by contrast, was licensed in 1995 after a randomized trial on about 1,000 children. But Merck’s expensive gamble on ROTATEQ appears to be paying off. The company expects the CDC and the American Academy of Pediatrics to recommend ROTATEQ for every infant in the United States, a market of 12 milliondoses each year. Merck will likely share this market with GlaxoSmithKline, which has its own rotavirus vaccine in the works.

Still, the U.S. sales, along with investment by the Bill & Melinda Gates Foundation and other donors, may help underwrite Third World distribution of the rotavirus vaccine. Thus, everyone stands to benefit from a rigorous testing process intended to assure that only the safest vaccines get on the market—thousands of American babies stay out of the hospital; thousands of babies in poor countries survive infancy, and Merck regains some of its pre- Vioxx reputation as a drug company that cares about health as well as profits.

The public is still being asked to take a risk, though a small one. The Merck trial found a larger number of seizures in children who received the vaccine than in the placebo group. There’s no good biological explanation for this increase, so it was probably a chance finding. (The study also found that unvaccinated children cried more and had more broken legs—two obvious statistical flukes.) But even a vaccine successfully tested on 36,000 children could end up having unexpected effects. Measles vaccine, for example, causes a blood-clotting disorder in perhaps 50 of the 4 million children who get it each year. And whooping cough vaccines on rare occasions cause seizures that are followed by brain disorders, although the vaccine may not be to blame for permanent damage.

As a society, we’ve decided of course that it’s worth risking such tragedies in exchange for protection from the graver threat of widespread measles and whooping cough disease. Families who accept vaccination receive protection from sickness themselves; they are also in a sense soldiers in a larger war on infectious diseases. We’ve also decided that it is our social duty to shield vaccine companies from runaway juries. So, we recompense the occasional victim of vaccination through the no-fault vaccine court, staffing it with experts who know about the type of injuries vaccines can cause and funding its relatively modest judgments through a vaccine excise tax.

Whether or not drug companies really need a liability shield is concealed in their proprietary balance sheets. But there aren’t many companies that can make pandemic flu vaccines, and history has shown that they just won’t make themunless we provide this shield. In 1976, President Ford ordered mass immunization following the detection of the “swine flu” influenza virus in an Army recruit who died from it. That year, production of the vaccine was delayed several months because the drug industry could not get insurance. Congress finally underwrote the campaign, and the insurance industry turned out to have been right—the vaccine was associated with an unusual paralytic disease called Guillain-Barré syndrome. The federal government had to handle 5,000-plus claims from allegedly vaccine-injured patients and paid out nearly $100 million in compensation.

Any injuries caused by Merck’s ROTATEQ vaccine, assuming it makes its way to the public, will be covered by the vaccine court. And in light of the history of the vaccination program, that’s a good idea. But Congress’ treatment of pandemic flu vaccine makers takes risk-protection to an excessive level. The bill would make it impossible to sue a vaccine or antiviral drug-maker without proof of “willful misconduct.” This will be almost impossible to prove, because the bill stipulates that any claim of injury would be adjudicated not by judges, with their investigatory powers, but by the secretary of the Department of Health and Human Services. The bill protects companies without establishing a fund to pay potential vaccine victims. This is not a reassuring decision, and since vaccination programs rely on public trust, it is a remarkably shortsighted one. Even drug company officials were worried that the measure could further harm their reputation and diminish confidence in vaccines. Apparently, however, House budget hawks were adamant that the bill contain no compensation provision that costs money and thus adds to the federal deficit.

Flu vaccines today are safer than they were in 1976. But it should be the duty of experts on vaccine safety, and not HHS Secretary Mike Leavitt, to decide whether a bad outcome after vaccination was caused by the vaccine. In the battle against dangerous bugs, our troops—which is to say, ourselves—deserve better.