Dealing with Adversity

There are at least two indisputable truths about vaccinations. Next to clean water, nothing else has had such a significant impact on public health. The second certainty is that reasonable people will disagree over who should be immunized against which disease.

Vaccination mandates, however, make that argument moot.
In defending the safety record of vaccines, public-health officials and manufacturers argue that the overwhelming number of serious adverse reactions to certain immunizations is coincidental. Perhaps not so coincidental are the ever-expanding government "recommendations" on which vaccinations should be administered to children since 1986. That's the year Congress passed the National Childhood Vaccine Injury Act, which established a no-fault system to compensate individuals and families with recognized vaccine injuries. Immunizations covered under the act include diphtheria, tetanus, pertussis (DTP), measles, mumps, rubella (MMR), two types of polio vaccine, influenza, chicken pox and hepatitis B.

Ostensibly the compensation system offers a kinder, gentler alternative to courtroom litigation, which is expensive and demands a greater burden of proof from plaintiffs. The act specifies certain awards -- $250,000 for death, up to $250,000 for pain and suffering -- if it can be shown that the person received the vaccine and then suffered certain symptoms within a certain period of time.

Another, less-stated goal of the act is to protect the future supply of vaccines by shielding the manufacturers from liability. Monetary damages paid out through the compensation program --more than $1 billion since 1988 -- are funded by an excise tax on vaccines covered under the vaccine-injury act.

While the act has helped many people through a horrible experience, its ultimate value in ensuring the best public-health policy regarding vaccines is questionable. For one thing, it's run by the government, whose lawyers, in essence, represent the drug companies during the claims process. Their evidence --presumably submitted to show the vaccine wasn't to blame -- originates with vaccine manufacturers, who pass the data from clinical trials to the federal Food and Drug Administration for approval and licensing, which in recent years has invariably led to a recommendation for universal use in children by the Centers for Disease Control.

On the other side of the claims-court aisle, even though no actual causation is required to receive compensation under the act, lawyers for those alleging a vaccine-related injury -- whose fees, it's important to note, are determined by the government -- need as much information as they can get.

Where do they get it? The same place the government lawyers get theirs: the manufacturers, the FDA and the CDC. Unfortunately, very little of the information about the hepatitis B vaccine is useful in the compensation proceedings, largely because there's not enough of it to prove or reject a connection between the vaccine and injury or illness.

"Because this is a no-fault system, we're looking for any way that we can to prove a particular vaccine causes a particular injury," says Cliff Shoemaker, a Washington, D.C., attorney who specializes in vaccine-injury claims. "And that's difficult to do because the government controls the data."

One source that might be expected to shed some light on adverse reactions to vaccines is the federal Vaccine Adverse Events Reporting System, or VAERS.

According to a vaccine-safety study by the Institute of Medicine, which advises the federal government on health care issues, VAERS is useful in "flagging potential problems" but was not designed to point out the incidence of adverse reactions over the long term. That's because VAERS does not collect enough medical and pathological information on reported cases, and therefore is not likely to flesh out which reactions need further study.

That the government's own reporting system, set up through an act of Congress whose aim was to help vaccine-injured people, does little to help determine how a vaccine might hurt someone may not be a complete accident, says Ron Kennedy, an immunologist at the University of Oklahoma Health Science Center.

"I'll tell you the reason," says Kennedy. "Because the pharmaceutical companies don't necessarily want to know."

Indeed, a 1988 review of "postmarketing surveillance" by the CDC found that, due to the lack of scientific data, no causal relationship between vaccine and injury could be proven. However, the agency said, neither could one be ruled out. The CDC didn't speculate on why more data wasn't available, but the Institute of Medicine, in the 1994 study on vaccine safety, blamed vaccine manufacturers, which did not include enough patients in their clinical trials to detect the possibility of rare adverse reactions.

Nor was much useful information provided by the postmarketing surveillance conducted by Merck and SmithKline Beecham after the vaccines were licensed, according to the institute. For one thing, the vaccine manufacturers themselves acknowledge that, because of under-reporting by physicians, the postmarketing studies are not representative of the actual reactions that occur.

More troubling is that, apparently, hepatitis B isn't the only mystery vaccine out there. In the conclusion of its 1994 study on vaccine safety, the Institute of Medicine issued this sobering assessment of the overall quality of vaccine research:

"The committee encountered many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines.... Clearly if research capacity and accomplishment in these areas are not improved, future reviews of vaccine safety will be similarly handicapped."

It has been nearly a decade since the CDC recommended that all newborns, infants and children receive the hepatitis B vaccine. Despite the proliferation of VAERS reports suggesting the vaccine causes injury, even death, independent research studies needed to prove or reject causation have not been performed. Money is tight, and few institutions, including the federal government, are willing to allocate funds for the study of something that public-health officials have already determined to be safe.

Under pressure from parents groups and safety advocates, both government and the vaccine manufacturers are finally taking a closer look at the hepatitis B vaccine, albeit in a rather narrow context.

The CDC is examining the database of six million patients collected from four West Coast health maintenance organizations to measure the incidence of multiple sclerosis in those who received the hepatitis B vaccine. The possible link to multiple sclerosis is also the subject of a Harvard Nurse Health Study, paid for in part by Merck, as is an investigation by the French government.

But aren't these studies just a little bit late? More than one billion hepatitis B vaccinations have been administered worldwide over the last 15 years. Hepatitis B vaccination is a mandate for every child living in 36 states who wants to go to grade school. And more vaccines are on the way. Why not find out, once and for all, how safe they are, before encouraging their widespread use?

"There very well may be a very small percentage of children who react to vaccines, but if it's your child, it's 100 percent," says Shoemaker. "And if it's your child who's a vegetable, people can talk statistics until they're blue in the face. It's not going to be very impressive."

-- Brian Wallstin


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