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Fighting fear as well as smallpox in debate over vaccinations

May 2003
Karen Southwick

Pathologists and laboratorians face the same thorny decision as other health care workers: whether to participate in the federal smallpox vaccination program.



Under the direction of the Centers for Disease Control and Prevention, the program is in its first phase, in which designated health care workers who would be expected to interact with possible smallpox patients are vaccinated. Phases two and three would widen the vaccinations to emergency officials, such as police and firefighters, and finally the public, all on a voluntary basis.



It is phase one that is divisive for the nation’s hospitals, especially since cardiac fatalities possibly related to the vaccine were reported in late March. In addition to the health risks the vaccine—live vaccinia virus—poses to the person who receives it, that person may also expose others, especially those who are immunocompromised or suffer from certain skin conditions, such as eczema.



Couple those risks with uncertainty about whether workers’ compensation covers health care workers who become ill from the vaccine and who will pay if health care workers expose family members or patients, and you have a rationale for the fierce debate over smallpox vaccination.



“This vaccine does have side effects,” says Jared N. Schwartz, MD, PhD, chair of the CAP Ad Hoc Committee on Preparedness for National Emergency and director of pathology and laboratory medicine at Presbyterian Health Care, Charlotte, NC. But with stockpiles of smallpox known to exist in certain countries, “there is a risk—extraordinarily

small, but not zero”—of a bioterrorism attack on the United States involving smallpox.



For that reason, says Dr. Schwartz, the ad hoc committee “strongly supports the CDC recommendations to inoculate teams of health care workers at hospitals and public health agencies.” The CAP Board of Governors accepted the committee’s stance and last November declared a formal policy on smallpox vaccination.



The policy, which favors a “voluntary pre-outbreak phased approach,” says that those who may have initial contact with the smallpox virus in the event of an attack should be vaccinated first. This group encompasses health care providers, including “appropriate laboratory workers,” as well as police, firefighters, medical examiners, and others. The general public should be given the option of vaccination following the inoculation of “first responders,” the policy adds.



Dr. Schwartz says committee members felt it was important to anticipate the possibility of a panic if someone were to arrive at an emergency room with possible symptoms of smallpox. “If you have immunized health care workers ready to evaluate that patient,” he says, “they would not fear getting smallpox or giving it to others.”



In addition, if a real case of smallpox were to appear, this same group of health care workers would be designated to immunize the general public. “You need a core group who would have no reason to be panicked [over a smallpox attack] to begin the process of mass inoculations,” he explains. This methodical approach would minimize the chance of side effects from the vaccine itself while at the same time putting an action team in place for a possible attack.



According to the CDC, for every million people vaccinated, between 14 and 52 will experience a severe reaction, one or two will die, and there will be 20 to 60 cases of accidental transmission to another person. In late March, reports surfaced that three people, out of about 25,000 health workers and 350,000 military personnel inoculated, had died of cardiac-related problems.



Several states, including California and New York, temporarily suspended their vaccination programs while the CDC investigated. “There’s no proven connection at this point” between the cardiac deaths and the vaccine, says CDC spokesman Von Roebuck. On March 29 the CDC recommended that vaccinations of health care workers proceed but that an additional screen be added to weed out people with heart disease or risk factors such as hypertension, diabetes, or high cholesterol.



The American Hospital Association has not made a recommendation to its members. “We took two positions: This [vaccine] should be made widely available to more than one hospital in a region, and this should be strictly voluntary,” says Jim Bentley, senior vice president of strategic policy planning for the AHA.



Of 5,000 AHA members, about 20 percent have said they will not vaccinate, another 20 percent are considering it, and the rest appear to be complying, Bentley says. At the very least, “hospitals will have to make a judgment as to how they are going to operate if they get a patient who could have smallpox. Even the hospitals that have said ‘no thanks’ generally have

a plan.”



To vaccinate or not?

Dr. Schwartz emphasizes that the decision to be vaccinated is a personal one. “The leadership within given institutions and states will have to make the decision [to participate in the CDC program] based on cultural and other factors,” he says. “Then it’s up to the individual workers.”



Although Dr. Schwartz says he would be vaccinated if he could, executives at his hospital, Presbyterian Health Care, have chosen not to participate at this time. “They are not ruling it out,” he says. “They are just saying that they want to see how the first phase goes and then review the situation.”



The decision not to vaccinate “was made at a corporate level,” says Dr. Schwartz. “They decided there wasn’t enough information available about the ramifications.” But he says if that changes, he will be vaccinated. “As director of the lab and as a microbiologist, I’d feel an obligation to set an example,” he says. “If there’s protection available, you should take advantage of it. And if there was a [smallpox] case in the community, I’d want to be available to help immediately.”



Thomas Cooper, MD, a staff pathologist at Centinela Medical Center, Inglewood, Calif., is in the same position as Dr. Schwartz. His hospital, part of the Tenet Healthcare chain, has not yet decided whether to participate, although he expects that to change. Centinela is the hospital for the Los Angeles International Airport and as such could find itself on the front lines of an attack.



“We have an internal plan in which we recommended that a certain number of people should be vaccinated, such as ER physicians and nurses,” Dr. Cooper says. He will probably be among them. Dr. Cooper, who was a member of the U.S. Navy’s biological warfare decontamination team, represents the Los Angeles County Medical Association on the board of supervisors’ bioterrorism committee. “Given the position that I have and the knowledge that I have from past military experience, I would expect to be called on in an emergency,” he says.



If somebody does come down with smallpox, the plan will be reactive, Dr. Cooper adds. L.A. County plans to set up mobile hospitals to do mass vaccinations, the number of which will depend on how many cases of smallpox occur. But where there’s a significant outbreak, “all bets are off,” he says, meaning that health care officials would not be able to vaccinate fast enough to prevent widespread infection.



All hospitals should have an isolation plan in case someone arrives at the emergency room who might have smallpox, Dr. Cooper says. The plan should identify a team of responders to care for the person. Fortunately, smallpox is not infectious until the rash is evident.



Nevertheless, the response window is too small to plan on vaccinating after the disease manifests itself, Dr. Cooper maintains. “Not vaccinating at all is a bad idea. If this [infected] person shows up and nobody has been vaccinated, who’s going to handle it? How many nurses, orderlies, and other workers are even going to show up for work?”



There are legitimate reasons to be concerned about the vaccine, Dr. Cooper concedes, including the potential threat to immunocompromised and elderly patients. The person who is vaccinated will shed the vaccinia virus for seven to 10 days, though the CDC guidelines suggest there’s little danger if the wound is kept covered and inspected daily to make sure it isn’t festering.



In contrast to California, where hospitals have been slow to participate in the vaccination program, the New York City area expects to be a target of a terrorist attack, so hospitals there are more interested in participating in the CDC program.



“We’re just outside of New York, and you’d have to be out of your living mind not to think there was a risk here,” says Thomas Sodeman, MD, chairman of laboratory medicine at North Shore Long Island Jewish Health System, which encompasses 18 hospitals.



“This is a very big deal in this institution,” he adds. “We have a command center, and we’ve trained over 2,000 people in hazmat [handling hazardous materials].” The health system is also an eager participant in the CDC vaccination program, with more than 700 employees volunteering to be immunized, including ER physicians, emergency medical services workers, and infectious disease specialists. Dr. Sodeman expects about 200 to be vaccinated in the first wave. He himself didn’t volunteer because “it’s not worth a dose. I’m not on the front lines,” he says.



The goal of the plan is to have a team of people in place to triage infected patients, he adds. “You don’t necessarily need a care team in every hospital because we can designate a central facility to do the care.” That central location will not be a tertiary care facility, because of the danger to the patients there, but more likely an extended care facility.



Dr. Sodeman says about 50 people at North Shore Long Island have

been inoculated, and none have experienced complications. Vaccinated workers report daily to the infectious disease department to have their wounds checked. They’re told to keep the sites dressed and covered while they’re working.



In Nebraska, too, response to the vaccination program has been strong. “We have completed phase one of pre-event vaccination, the immediate-response health care teams,” says Thomas L. Williams, MD, medical director of the Methodist (Hospital) Pathology Center, Omaha.



Nebraska has been one of the states participating aggressively, he says, with more than 1,400 people vaccinated, among the highest number in the country. Eighty of 86 hospitals in the state have chosen to vaccinate health care workers.



Dr. Williams, who serves on the Nebraska Bioterrorism Advisory and Hospital Preparedness committees, says vaccination is a policy decision, not a medical one. “Medical decisions are based on medical risks. Policy decisions are based on public health risks and military intelligence,” he says. “That requires specialized knowledge that we as physicians

don’t have.”



When federal institutions that do have that knowledge, such as the CDC, recommend vaccination, “it’s our job to do it,” he says. “This is a potential national emergency. The risks of the vaccine, particularly if you have been previously vaccinated [as a child], are nil.”



Dr. Williams says 26 people have been vaccinated at Methodist Hospital, mostly nurses and some physicians, including two pathologists in his department. He would have joined them had his son not had eczema. “The vaccination site on your arm is potentially shedding live virus for several weeks,” he explains. “A family member could acquire vaccinia.”



One pathologist who was vaccinated is Nancy Cornish, MD, director of microbiology for Methodist and Children’s Hospitals, Omaha. “It was something I could do for my country,” she says. “I’m healthy and didn’t have any of the risk factors.”



As a microbiologist, Dr. Cornish could be asked to help identify a smallpox culture, “but that’s not why I got vaccinated,” she says. Rather, it was because of the United States’ war with Iraq. “This is something I could do to help.” If there was a bioterrorist attack, “I could help vaccinate other health care workers.”



Dr. Cornish believes the risks of the vaccine have been overstated. She points out that anyone older than about 40 probably was vaccinated as a child, since smallpox was a routine part of childhood inoculations into the 1960s. “One of our lab supervisors in her 60s has been vaccinated four times,” she says. “There’s more risk from general anesthesia.”



If you take the proper precautions, keep the wound covered, and don’t touch it, “you don’t have to be concerned about spreading it,” she says. “I was able to work normally the whole period” after the vaccination.



The decision to participate in the phase one vaccinations is generally made at the highest level of a hospital or health care system with input from the medical staff. “This poses a fascinating ethical dilemma for leaders,” says Nick Turkal, MD, a family practitioner who is senior clinical vice president for the 12-hospital Aurora Health Care system, Milwaukee.



Aurora management agonized over the decision, Dr. Turkal says. “We’ve spent a good deal of time debating the pros and cons of the vaccination program, including risk to employees, family members, and patients. We always want to avoid risk unless we feel that there is adequate reason for it. In this case, we came to the conclusion that vaccination of a limited number of employees made sense.”



Aurora cares for more than a million people in eastern Wisconsin, Dr. Turkal says. “We felt it was our responsibility to the communities we take care of to be ready.” Terrorists, he adds, “work by making people afraid. The more ready we are, the less afraid we are, and the less attractive we are as a target.”



The state of Wisconsin waited to see how the program proceeded in other states before it went ahead, he says, “so we were able to get a very good handle on side effects and risks.” In the end, “I’m very comfortable with our decision to vaccinate at Aurora.”



The system worked closely with its workers’ compensation provider to make sure the people who were vaccinated would be covered. The health care system itself agreed to cover sick days up to the time that workers’ comp would kick in. As for potential injury to family members, “our approach was to aggressively screen out anyone who had someone at risk,” Dr. Turkal says. “If there was any doubt, we encouraged people not to be vaccinated.”



Of the system’s 24,000 or so employees, 250 were slated to be vaccinated this spring, he says. The intent is to have a small core team at each hospital that could handle a smallpox case. When the cardiac issue surfaced, “we added a screen for anyone who has a history of problems, but we’re going ahead with the vaccination program,” Dr. Turkal says. “We don’t know for sure if there’s an association.”



Dr. Turkal was in the first group vaccinated. “I’ve had no significant problems and continued to care for patients,” he says. During the period the wound was evident, vaccinees were advised to have the site checked daily, keep it covered at all times, and wear long sleeves.



Including lab workers

The CDC guidelines on hospital workers who should be vaccinated include physicians, nurses, emergency room personnel, and housekeeping staff, but they do not mention laboratorians. The guidelines, however, allow hospitals to offer those workers not mentioned the opportunity to be vaccinated.



“I think lab workers should be offered that option,” says Mike Miller, PhD, chief of the laboratory response branch of the CDC’s bioterrorism preparedness program. He points out, though, that the way the CDC program is designed, if smallpox were suspected, the sample would be sent to a designated lab within the Laboratory Response Network. The LRN encompasses state and county public health labs, Defense Department labs, and some hospital labs. Dr. Miller says 118 facilities nationwide have been designated as part of the LRN. (LRN personnel would, of course, be offered vaccination.)



A typical community hospital, therefore, probably would not process samples of suspected smallpox but would send them on to designated LRN facilities instead. “Labs will not be involved in testing for smallpox unless they are members of the LRN,” he says.



For research workers handling infectious virus, the CDC recommends level four precautions, says Inger Damon, MD, PhD, chief of the pox virus section within the CDC’s division of viral diseases. “By using standard precautions, infectious particles could be controlled to minimize the risk.”



If patients are being treated for smallpox, however, hospitals “will be taking hematology and chemistry specimens” to monitor the disease, says Dr. Miller. While “isolating the agent will not be done at the local hospital, patient care will be.” But this presents a very low risk to laboratory personnel, he says.



The CDC Web site (www.cdc.gov) contains extensive information on lab preparedness in the event of a smallpox attack, including algorithms on how to identify high-risk patients and prepare and transport specimens. Local labs that aren’t part of the LRN will be involved in testing for non-smallpox rashes, such as herpes and chicken pox.



But pathology and laboratory experts point out that lab workers could end up testing a smallpox specimen if the origin of a patient’s rash or fever is not immediately obvious. Very few clinicians in the United States, except some with overseas military experience, have ever seen smallpox. So the experts say two categories of lab workers may wish to be vaccinated: those in virology or microbiology, who could be involved in handling or culturing a specimen, or both; and phlebotomists who might draw blood from a smallpox patient.



“Neither the lab staff nor the medical staff should be handling patient specimens [from a suspected smallpox victim] unless they have been immunized,” says Dr. Schwartz. To do so, he adds, jeopardizes not only oneself but also other health care workers and patients.



However, “we can grow smallpox in the labs without even knowing whether it’s smallpox,” says Christine C. Ginocchio, PhD, director of the microbiology, virology, and molecular diagnostics labs at North Shore Long Island Jewish Health System. “Even though we work in biohazard hoods, the workers could be exposed.”



For that reason, the health system offered vaccination to virology lab workers as part of an overall program, although Dr. Ginocchio was the only one who chose to be vaccinated. “I just felt like if we have to work with these specimens, I wouldn’t expect my staff to do anything I wouldn’t do,” she says.



North Shore Long Island will do direct fluorescence antibody tests on scrapings from facial lesions. DFA tests can determine immediately whether a person has herpes or chicken pox, but not smallpox. If the lesion is not one of the first two, a molecular assay is needed, and that would provide results within two or three hours, Dr. Ginocchio says. If it is smallpox, then a CDC-designated laboratory would take over.



Omaha-based Methodist Hospital, on the other hand, “did not permit lab workers to be vaccinated,” says Dr. Williams, a decision with which he disagreed. “This meant our phlebotomists were ineligible. And workers in the laboratory could be handling specimens from vesicular skin lesions, which are infectious.”



But Children’s Hospital, a neighboring institution, did allow laboratory workers to be vaccinated. “I felt that lab people should be eligible, especially since they work with the specimens,” Dr. Cornish says. Even though the CDC expects smallpox specimens to be delivered to a public health lab or other LRN lab, “we could be handling a specimen inadvertently.”



Dr. Cornish lays out this scenario: “The laboratory receives a specimen on a lesion believed to be herpes or chicken pox, but the DFA antibody reading is negative and the specimen is set up for culture. We read our viral cultures at two and at five days, so it could take us up to five days to see the cytopathic effect and know it was a virus,” she says. “Then we would call the public health lab, but by that time we’ve manipulated the specimen quite a bit.” And, she notes, you’re supposed to be vaccinated within four days of an exposure, but it could take up to five days for the CPE to be apparent.



Aurora Health Care, which uses lab-based phlebotomists to draw blood, chose to include some of them in the vaccination program, along with physicians, nurses, respiratory therapists, housekeeping, and security personnel, Dr. Turkal says. “Once there’s a known case, we would do a mass vaccination of our employees.”



AHA’s Bentley says each hospital must decide which departments will be offered the vaccination. “They have to get together a team involved in caring for the patient,” he says. “I can’t imagine that the lab isn’t going to want somebody to be vaccinated. Lab medicine is not an optional service.”



A special issue

The Jan. 30, 2003 issue of the New England Journal of Medicine contained several articles on smallpox vaccination. Two experts who wrote articles for the issue expressed cautious opinions on the U.S. approach, especially as it pertains to health care workers at large numbers of hospitals.



“A terrorist introduction of smallpox could produce a short outbreak of cases and deaths, but the current vaccination policy will provide little protection, and the cost in deaths from vaccine complications will outweigh any benefit,” wrote Thomas Mack, MD, MPH, professor of preventive medicine at the University of Southern California’s Keck School of Medicine, Los Angeles. “Only if evidence suggests that a massive attack or sustained biologic warfare is probable can such a vaccination policy be justified.”



Rather, Dr. Mack suggests designating dedicated hospitals to take in any patient suspected of having smallpox. “No suspicious patient should be admitted to or even knowingly examined at a general hospital,” he said. At the dedicated facilities, which could be National Guard field hospitals, limited numbers of preselected workers, including diagnostic lab personnel, “should be recruited, vaccinated, and committed to serve wherever necessary in the event of an introduction [of smallpox].” This group would comprise no more than 15,000 people nationwide.



“It just doesn’t make sense to vaccinate a lot of people because of the risks involved,” Dr. Mack told CAP TODAY. Preferably, he says, the response team of 15,000 would be composed of people who were vaccinated as children and include nurses, epidemiologists, law enforcement personnel, and others who would interact with the patient.



In the same issue, Kent A. Sepkowitz, MD, director of infection control at Memorial Sloan-Kettering Cancer Center, New York, reviewed the likelihood of secondary transmission of the vaccinia virus in a hospital setting.



Modern health care workers take risks that were not common in the mid-20th century, when vaccination was last done on a large scale. At that time, he wrote, cancer chemotherapy was just beginning, transplantation had not yet been performed, and HIV was unheard of. Today, millions of people with cancer, rheumatoid arthritis, and asthma are being treated with immunosuppressive agents. Tens of thousands of transplant recipients are also receiving therapy. Also at risk are newborns in neonatal ICUs and children with skin ailments such as atopic dermatitis. In addition, many health care workers are themselves immunocompromised.



Until controversies over how to deal with vaccinated workers who become ill or what to do with immunocompromised employees are settled, “hospitals must be certain that the rush to vaccinate health care workers does not result in a self-inflicted epidemic—not of smallpox, but of infection with the live, potentially lethal virus, vaccinia,” Dr. Sepkowitz said.



Dr. Sepkowitz told CAP TODAY, however, that the CDC phase one program for health care workers “is an incredibly cautious program where an individual who is interested in participating will be talked to and advised ad infinitum.” Consequently, he believes it makes sense to vaccinate a group of health care workers “who will make up a very informed team vaccinating the next wave.”



The CDC plan “to me is remarkable in its sanity,” he says. “It emphasizes screening out people with risk factors with tremendous caution and care.” The recent outbreak of an unknown communicable disease, SARS, which at CAP TODAY press time had spread largely among health care workers in Hong Kong, “shows that health care workers are uniquely vulnerable,” Dr. Sepkowitz says.



He declined to say whether he would be vaccinated, because “it is a private decision.” But Dr. Sepkowitz did say he would not be afraid to undergo inoculation. “The most important thing is to preserve people’s right to make their own decision,” he says, “because there’s never been anything like this before in a health care context.”



Karen Southwick is a writer in San Francisco.