Claims Swamp U.S. Agency That Pays for Vaccine Injuries

A federal program designed to ease the financial burden on families with children injured by vaccines has led to an epidemic of costly claims against the government--and a bitter controversy between medical scientists and parents’ groups.

The program, created in 1986, was intended to provide a no-fault alternative to damage suits, which had been driving pharmaceuticals manufacturers out of the vaccine business and jeopardizing efforts to eliminate childhood diseases.

BACKGROUND: Federal legislation set up a government agency to process claims of injury from vaccines and pay damages in cases judged to be valid. Authorities would not try to assess blame for the injuries. And the families of the youngsters would receive prompt help.

During its first three years of operation, however, the program has sparked an avalanche of costly claims that is threatening to bust the budget and force the government to consider rationing some vaccines in case of a serious emergency.

It has also led to sharp disagreements over what constitutes a valid claim. Some medical authorities contend many of the awards the government has made so far have been for injuries that may not have been caused by vaccines.

The drain on federal resources has far exceeded expectations. The 179 claims that the U.S. Health Resources and Services Administration has processed so far have cost taxpayers $108.2 million--from a low award of $58,597 to a maximum of $2.9 million.

And the agency estimates that the cost of paying off the 4,100 petitions received so far could exceed $3 billion.

As a result, Washington already has begun to tighten its purse strings. In March, a federal advisory commission voted to impose a moratorium on awards, pending action to ease the budget situation and possibly revise the scientific criteria for deciding cases.

Rep. Henry A. Waxman (D-Los Angeles), sponsor of the original legislation, warns that, if the program falters, the government may have to consider rationing during emergencies because manufacturers again will be reluctant to produce vaccines. “I don’t think anyone wants that result,” Waxman asserted.

But the most controversial dispute may be over what injuries should be covered. Some industry critics--and a few commission members as well--complain that the criteria for judging whether a case is valid are outdated and too broad.

For example, a high proportion of awards has involved injuries said to have stemmed from administration of whooping cough vaccine, which usually is administered together with diphtheria and tetanus vaccines. Whooping cough vaccine has been suspected in past years of having occasionally caused some brain damage in children.

But authorities say more recent studies have cast doubt on the contention that pertussis vaccine can cause brain damage, and the occurrence of brain damage following a DPT vaccination could well be coincidental and actually stem more from other factors, such as infection.

Neurological and pediatric organizations in the United States, Canada and England say DPT has not been shown to cause brain damage, and they argue the data used to support contentions that it has are unconvincing.

OUTLOOK: Although no one doubts that some vaccines have caused injuries--and even deaths--medical scientists continue to insist that the number is very small compared to the public health benefits of the 20 million shots administered annually.

But parents and their lawyers contend their claims are just. Dissatisfied Parents Together, a parents’ organization, plans to sue the health resources agency for failing to carry out a provision requiring it to distribute information regarding possible adverse reactions to vaccines.

It is too early to tell how these problems will play out, but for the moment the entire compensation program seems to be in jeopardy.