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Smallpox vaccine stalled { February 24 2003 }

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   http://www.washingtonpost.com/wp-dyn/articles/A55239-2003Feb23.html

http://www.washingtonpost.com/wp-dyn/articles/A55239-2003Feb23.html

Bush Smallpox Inoculation Plan Near Standstill
Medical Professionals Cite Possible Side Effects, Uncertainty of Threat

By Ceci Connolly
Washington Post Staff Writer
Monday, February 24, 2003; Page A06


When President Bush issued the call for 500,000 volunteer health care workers to be immunized against smallpox, Health and Human Services Secretary Tommy G. Thompson promised to get the job done in 30 days.

At today's one-month mark, however, the total number of people inoculated nationwide is just 4,200 -- less than 1 percent of the administration's target for the first phase of bioterrorism preparations.

"It is as close to stalled as you can get," said William Bicknell, former Massachusetts health commissioner and a professor at the Boston University School of Public Health. "There has not been a sufficient push from senior administration officials."

Although the federal government has shipped 274,000 doses of vaccine to states since the program began Jan. 24, hundreds of hospitals, a half-dozen major unions and even some public health departments have refused to participate. Even the states that are vaccinating volunteers report that they have drastically scaled back their original plans.

Aside from a few pockets of enthusiasm, the vast majority of medical professionals remain unconvinced that the threat of a smallpox attack is serious enough to administer a vaccine known for its serious side effects, especially when federal officials have refused to create a compensation fund for people sickened by the vaccine.

"At this point I'm more concerned about seeing a vaccine complication than a case of smallpox," said Steven Gordon, hospital epidemiologist at the Cleveland Clinic, where fewer than 100 of thousands of eligible employees will be inoculated next month.

The slow start has alarmed many national security experts who fear the looming war with Iraq will increase the likelihood of a biological attack on the United States.

"If anything happens in the near term, we will be in serious trouble," said Edward Kaplan, who teaches public health management at Yale's School of Management and School of Medicine. "It seems at a time when the risk is going up, we're advertising loudly this is one threat we're not ready to deal with."

Bicknell said that until the government reaches President Bush's ultimate goal of vaccinating millions of medical personnel and emergency responders, "we are not protected." In the event of a smallpox attack, those are the medical and emergency workers who would be needed to treat early cases and rapidly open mass vaccination clinics for the rest of the population. Experts believe that many people can survive a smallpox exposure if they are vaccinated within 96 hours.

Julie Gerberding, director of the Centers for Disease Control and Prevention, played down the focus on numbers of people immunized, saying the true measure of the program is whether the entire nation could be vaccinated within 10 days of an attack.

"We are not there now," she acknowledged. In an effort to revive the program, Thompson plans to make a personal appeal at today's session of the National Governors Association, and Gerberding is preparing to send informational packets to 3.5 million doctors, nurses and nurses' assistants.

When Bush announced his unprecedented immunization program Dec. 13, he said the goal was to protect the nation's frontlines here and abroad. He ordered mandatory inoculation of 500,000 military personnel and called for as many as 10.5 million medical workers and emergency responders to be vaccinated on a voluntary basis.

Later that afternoon, in a meeting with Washington Post reporters and editors, Thompson outlined an ambitious timetable: One month for the first 500,000 immunizations and an additional 90 days for millions more. At the time, the Bush administration said anyone who suffered a serious complication could apply for workers' compensation benefits or sue the federal government for negligence.

That policy has proved a major obstacle for the program. Some unions that represent tens of thousands of health care workers advised their members not to be vaccinated until the government offered compensation for potentially severe side effects, which include blindness and encephalitis.

"They should be covered the same way a police officer is covered if he is hurt in the line of duty," Kaplan said.

Although smallpox has not been seen in this country in five decades, security experts worry that terrorists could use the highly contagious, deadly germ as a weapon. Inoculation with the live virus vaccine -- called "vaccinia" -- provides protection but can also cause complications in a small percentage of people immunized.

That tension has sparked an emotional debate among some of the country's most respected physicians, who are weighing the unknown risk of attack against the known risks of vaccination.

"This is a modern version of the first line of the Hippocratic Oath: Do no harm," said William Schaffner, chairman of preventive medicine at Vanderbilt University Medical Center. The hospital board's decision not to vaccinate employees was heavily influenced by concern that immunized workers could accidentally spread live virus to patients, many of them with already weakened immune systems, he said.

Gerberding, however, said that she is "a little bit concerned we may have overstated the adverse effects of vaccination." She and other experts said that with careful screening and inoculation site bandaging, adverse effects should be kept to a minimum. Of the more than 100,000 military personnel recently vaccinated, five have experienced severe but treatable reactions.

Another major factor was the lack of evidence regarding a possible smallpox attack. "It is not enough for someone -- whether it is the president or the secretary of state -- to say, 'I'm worried about this; trust me,' " Schaffner said. "We need more than that today as a profession and as a society."

Thompson and Gerberding acknowledged that it has been difficult to convey to the public an imprecise threat based on classified intelligence.

"We have to do a better job of explaining to them this is a possibility and it will be too late -- if it does happen -- to be able to get people vaccinated," Thompson said. "We need these individuals to be able to be vaccinated so they will in turn be able to vaccinate the masses in case there is a smallpox epidemic."

Much of the debate centers on the definition of "prepared." Many infectious-disease experts said stockpiling vaccine in regional locations, training staff and practicing emergency drills would adequately position them to handle an outbreak. But others said the panic likely to ensue with even a rumored case makes that unrealistic.

"Frankly, the more of these workers, along with police and fire personnel, who are vaccinated before an event occurs, the greater will be our ability to maintain essential services in the crisis situation of a deliberate smallpox release," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Many physicians said they have been unfairly pilloried as "unpatriotic" because they have not reached the same conclusion as the president.

"People are not ignoring the government recommendations, but they are trying to apply them to their own situations," said Jeffrey Koplan, former CDC chief and vice president for academic health affairs at Emory University, whose medical center has decided to vaccinate 20 people.

Officials at nearby Grady Memorial Hospital, for instance, decided not to inoculate staff in large part because "you can't walk on a ward without being near patients who are significantly immuno-compromised," he said. But at the local Veterans Administration hospital, staff members have accepted the need to be immunized because they are already treating military personnel who have been vaccinated.

For now, states such as Tennessee, Oklahoma, New Jersey, Illinois and Connecticut have cut in half projections of the number of people they will vaccinate during the first phase of the program. The CDC, meanwhile, has put plans for Phase 2 -- inoculating emergency responders -- on hold.

Hundreds of major hospitals -- including Virginia Commonwealth University in Richmond and Children's in Philadelphia -- do not plan to immunize any workers unless circumstances change. Several statewide nurses' associations have advised against vaccination, while the AFL-CIO, the Service Employees International Union and the American Federation of State, County and Municipal Employees have urged the Bush administration to postpone the program.

The health departments of Michigan, Arizona and New York City have not begun vaccinations while awaiting establishment of a compensation program.

"We're having all kinds of problems with it," said Doug Campos, medical director for clinical services at the Maricopa County Department of Health, which covers 3.5 million people in the Phoenix area. "The failure to anticipate this compensation issue was a major mistake."

Sources on Capitol Hill say the White House has been reluctant to commit money to a compensation program. But Thompson is confident one will be established. "Once we get the compensation fund out there, I think [the vaccination program] is going to move quite rapidly," he said.



© 2003 The Washington Post Company



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