Refuting Tort "Reformers" Claims that Law Suits Slow Vaccine Development

By David Michaels

Tort "reformers" have long contended (with little evidence) that fear of litigation has scared off vaccine manufacturers from developing new vaccines.

It has been more than twenty years since Congress established the National Vaccine Injury Compensation Program. The program was designed to ensure that anyone injured by a vaccine would be fairly compensated, while protecting vaccine manufacturers from liability. Even with this program, the pace of new vaccine development slowed to a crawl in the 1990s. Opponents of law suits, including President George W. Bush, regularly use the industry's inability to develop new vaccines as a rationale for limiting the ability of victims to sue.

It turns out, not surprisingly, that these âreformersâ were wrong. With no major change in the tort law, vaccine development, according to the New York Times, is âroaring back.â Times business columnist G. Pascal Zachary writes that

By the mid-1990s, however, innovation in vaccines had virtually come to a halt. Only a handful of companies even tried to develop new ones, compared with 25 in 1955.

But fear of liability, it seems, has had little to do with the failure of manufacturers to develop new vaccines. According to Zachary

in a stunning reversal, innovators today are chasing dozens of vaccines, stimulated by some recent high-profile successes. âPeople see vaccines as money makers,â says Paul A. Offit, chief of the infectious diseases section at the Childrenâs Hospital of Philadelphiaâ¦

As wealthy countries spend much more on health care, and as poorer countries put new emphasis on disease prevention, many companies are jumping into vaccine innovation, including major pharmaceutical makers like Astra Zeneca, Novartis and Pfizer. Two separate teams, one involving Dr. Offit at GlaxoSmithKline, and the other at Merck, created in recent years rotavirus vaccines for childhood diarrhea, a big killer in less developed countries.

âVaccine makers are tackling major public-health problems again,â says Adel Mahmoud, a vaccine expert and a professor in the department of molecular biology at Princeton. âThe size of the market is incredible, both in America and around the world.â Dr. Mahmoud was previously president of Merckâs vaccines unit.

Not surprisingly, the change is being driven not by laws that limit manufacturer liability but by market forces and new science:

Across the industry, the research pipeline is bulging. Companies are spending billions trying to develop vaccines for various cancers, staph infections and malaria. âWe are entering a new golden era of vaccinology,â says Gregory A. Poland, a vaccine expert at the Mayo Clinic in Rochester, Minn.

In addition to traditional one-size-fits-all vaccines, Dr. Poland foresees a new class of personalized vaccines tuned toward the particular genetics and biology of the individual. Personalized vaccines will be more cost-effective; today everyone gets the same series of three hepatitis B shots over six months, for instance, though researchers know that one in five people, on average, could get the same protection with fewer.

âTechnology will eventually allow us to do immuno-genetic profiles to tell me which viruses pose the most risks to a person,â says Dr. Poland, who works in this nascent field.

Personalized vaccines are likely many years away. So are vaccines for such vexing diseases as AIDS, a big killer whose variety and rapid mutations pose hard problems for vaccine makers.

Even so, potential markets look strong. Governments are more interested in funding vaccination programs after years of neglect, and public fears that vaccines cause harmful side effects are subsiding. Those fears are now largely discounted by medical experts. The specter of bioterrorism has also heightened interest in new vaccines, spawning new funding sources.

Notable for its absence from this column is even the mention of fear of liability as a problem. Letâs not forget that the next time we hear manufacturers cry that fear of law suits is stifling medical innovation.

David Michaels heads the Project on Scientific Knowledge and Public Policy (SKAPP) and is Professor and Associate Chairman in the Department of Environmental and Occupational Health, the George Washington University School of Public Health and Health Services.