Smallpox bills address compensation fears

Congress has recognized the need for a vaccine compensation program, but proposals fall short of health workers' needs, experts say.

By Joel B. Finkelstein, AMNews staff. April 21, 2003.

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Washington -- New volunteers for the government's smallpox vaccination program have slowed to a trickle as Congress bickers over the fine print of legislation to compensate health workers who experience severe side effects from the vaccine.

Several Republican bills have been introduced in Congress. One was rejected on the House floor when the GOP forced a vote on the measure. A second House copy of the bill is awaiting committee action. A Senate version of the bill was passed by the Health, Education, Labor and Pensions Committee.

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In general, these bills follow the proposal outlined by the Bush administration. Such a program would provide as much as $262,100 for fatal or permanently debilitating reactions to vaccination, with an annual cap of $50,000.

Democrats say those proposals would not provide adequate compensation for someone who can't go back to work or for families who have lost a loved one and breadwinner. They have argued for more generous packages with higher annual and lifetime limits.

"We're glad they are looking at this," said Pat Libbey, executive director of the National Assn. of County and City Health Officials. But he added that he doesn't understand why lawmakers are arguing over the details, considering the relatively low cost of compensating the few people who have severe side effects and the obstacle that the lack of a compensation program poses for the program's success.

Several fatal heart attacks following smallpox vaccinations have lent urgency to calls for a compensation program. Some vaccine recipients also have experienced temporary heart inflammation.

Although these events were not conclusively linked to the vaccine, the Centers for Disease Control and Prevention has recommended that people at risk for heart disease be screened out of the voluntary vaccination program. Meanwhile, Illinois and New York state stopped their vaccination efforts.

The bills also contain liability provisions to protect physicians and hospitals that provide the vaccine.

"Liability protections are critical to ensuring the success of the smallpox vaccination program," Michael D. Maves, MD, executive vice president of the American Medical Association, wrote in a letter to Rep. William J. Tauzin (R, La.), chair of the House Committee on Energy and Commerce. "We commend your efforts to clarify ... that physicians will be protected when participating in a smallpox vaccination program."

The issues addressed by the legislation are significant barriers to potential volunteers, Libbey said.

Health workers are concerned about the side effects of the vaccine and could face being out of work for a long time. Balancing the risk of side effects against the unknown risk of a smallpox attack is more difficult with no compensation program to fall back on, he said.

Uncle Sam wants you

More than 25,000 volunteers have received the vaccine so far, but that number falls far short of the 439,000 called for in the administration's strategic plan.

It is unclear whether a compensation program would boost the number of volunteers. Some physicians feel that the scientific evidence does not support a plan for widespread smallpox vaccination.

"I was feeling like a refusenik," said pediatric infectious disease specialist Michael Muszynick, MD, of his decision to forgo the vaccine. "It was as if I was not doing my part for God and country."

Dr. Muszynick, who works at Nemours Children's Clinic in Orlando, Fla., said his feelings changed once he saw how few people were getting vaccinated.

The smallpox vaccination plan is motivated more by politics than practicality, he said. "We're basing public policy on fear."

Other physicians stated more personal reasons.

"As of this moment, I have no intention of getting the vaccine, until there are confirmed cases of an outbreak," said Jeff Kalina, MD, an emergency medical physician at Methodist Hospital in Houston. "I have made this decision ... based on side effects, risk of serious illness, time off work and unintentional exposure of my family."

Those who have chosen to be vaccinated seem to be more concerned about their roles in a crisis than personal risk from either the vaccine or the possibility of a biological attack.

"It's a good idea to have a reservoir of immunity," said Gene Kallsen, MD, chief of emergency medicine at Community Medical Centers in Fresno, Calif., and the first one in line to get vaccinated at the centers.

Sleeve rolled up and no place to go

Even for the willing, getting the vaccine may not be easy. Many hospitals and medical centers are hesitant to participate unless they are clearly shielded from litigation for vaccinating people. Community Medical Centers had 50 volunteers, but it was the only institution in the area to have a program.

Assurances from the CDC aside, medical facilities are not sure whether and how long vaccinated workers should be kept away from patients, many of whom are immune-compromised. And while the federal program paid for the vaccine and administration, it did not cover the cost of follow-up or time off work for vaccinated workers.

After initially expressing qualms about the smallpox vaccination program, several medical organizations have largely come on board. But they are seeking more support and protection from the federal government before they pour their energy into implementing vaccination programs locally.

The GOP bills currently receiving the most attention in Congress fail that test, Libbey said.

They do not provide timely, first-dollar compensation, which is necessary to ensure that volunteers injured by the vaccine don't have to navigate a complicated bureaucracy to get the money, he said. These legislative efforts are also time limited, although those in the medical community expect vaccination efforts to be ongoing. Also, the bills do not cover the first five days taken off work for vaccinated workers who become sick.

"This compensation plan is solely focused on worst-case scenarios and does nothing to address the more common scenarios where individuals experience side effects that would cause them to lose less than five days of work," said Barbara A. Blakely, president of the American Nurses Assn.

The ANA and a coalition formed by the NACCH, the Assn. of State and Territorial Health Officials and the American Public Health Assn. prefer a bill sponsored by Rep. Henry Waxman (D, Calif.). That measure would not limit lifetime compensation for lost wages due to disability and would cap annual payouts at $75,000.

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