The Bush Administration is moving so quickly with its smallpox vaccination policy that it may lose sight of essential details, an Institute of Medicine (IOM) panel concludes in a report issued today. Education about the risks has to improve, the panel says, and plans to monitor side effects--ranging from rashes to brain damage and death--aren't rigorous enough. There's also no comprehensive plan to compensate the vaccine's inevitable victims.
In what was itself a 4-week rush job, the panel, chaired by epidemiologist Brian Strom of the University of Pennsylvania in Philadelphia, carried out the first scientific analysis of the Centers for Disease Control and Prevention's (CDC's) plan to implement the U.S. smallpox policy, announced on 13 December (ScienceNOW, 13 December).
The current timetable calls for rapid vaccination of almost 450,000 hospital workers, starting next week. This spring, in "phase 2," the vaccine will be offered to up to 10 million other medical workers, firefighters, and police. Although the IOM panel doesn't offer an alternative timetable, it presents a list of issues that need to be addressed before vaccination begins. It wants clear statements of the vaccine's risks in educational material for potential vaccinees, tested for clarity in different ethnic and socioeconomic groups. During the first phase, there should be more active surveillance for side effects than proposed by CDC, the panel says, as well as a study of why people chose not to be vaccinated. “We have to make sure we learn as much from the first phase as is possible,” says William Foege, a veteran of the smallpox eradication campaign and a consultant to the panel.
The panel also addressed problems with liability and compensation. The current patchwork of states' workers compensation laws and insurance plans may not cover some patients' loss of income or permanent disabilities, the panel cautions, which could lead people to opt out. If this proves a problem, the government should create some type of redress, the panel says--but at the very least, every vaccinee should know in advance what his or her rights will be.
Given all the hurdles, there's no way the Administration can stick to its timetable, comments Tara O'Toole, director of the Johns Hopkins Center for Civilian Biodefense Studies in Baltimore. “The government doesn't understand how feeble our public health system is,” she says. “They're on another planet.”
But in a press conference today, CDC director Julie Gerberding said that CDC has already addressed several of the issues raised by the panel, and that it may take additional steps in the coming weeks after a close review of the report. Although Gerberding acknowledged gaps in compensation plans, “we are certainly not going to delay this program because of [these] concerns,” she said.