Feb. 2003 Reporter Home

AAMC Spearheads New Quality Initiative

State Budget Cuts Put Strain on Teaching Hospitals

Innovations in Medical Education: "Communicating in Other Ways"

"A Shot in the Dark": the smallpox vaccination program

Dual-Degree Programs

Viewpoint: Women in Medicine: The Work that Remains

A Word from the President

"A Day in the Life of a Medical Student"

Reporter Archive

AAMC Newsroom

Managing Editor Scott Harris sharris@aamc.org Staff Writer Elissa Fuchs efuchs@aamc.org

A Shot In the Dark

A look at implementation of the federal government's smallpox vaccine plan

The University of Connecticut Health Center was the first to begin smallpox vaccinations in late January. Photos: Peter Morenus, UConn.

Last December, the White House issued a statement urging hospitals to administer smallpox vaccines to a voluntary cadre of healthcare workers, so that in the event of a bioterror attack, a core group of clinical and support staff would be prepared to manage casualties.

President Bush, who himself was vaccinated Dec. 21, ordered smallpox vaccinations for active-duty military, and recommended vaccinations for about 500,000 civilian medical staff as the first phase of a nationwide smallpox protection program. Late last month, the federal government began shipping the vaccine to several states, but it has been left to state health departments to decide how to implement the plan, and to designate hospitals to identify volunteers, from physicians to housekeeping staff.

The University of Connecticut Health Center was the first facility in the country to begin inoculating its workers. Surrounded by a contingent of media, four people at the center were vaccinated on Jan. 24. "CNN was here all day, and with everything going on overseas, we realized this was about more than just medicine; it's both politics and medicine," says James Walter, the center's associate vice president for communications.

The university's vaccine team will be conducting vaccinations throughout the state, under the auspices of the state's Department of Health, Walter says. "We'll have clinics every Friday, and the shots will be absolutely voluntary." Some nursing unions are holding off until the state resolves liability questions, he says, adding that the university's team plans to vaccinate 6,000 healthcare workers in Connecticut over the next few months.

But concerns over protecting the welfare of patients, healthcare workers, medical students, and the general public all have been driving forces in some of the early reactions of teaching hospitals and academic medical centers (AMCs) to the vaccine plan.

Curtis Lewis, M.D., chief of staff and senior vice president of Grady Health System in Atlanta, announced in mid-December that Grady would not be vaccinating. He says that because there is an absence of a verified bioterrorist threat, combined with "the known dangers" of the smallpox vaccine, Grady would "not vaccinate its healthcare workers for smallpox ... but would move rapidly to vaccinate healthcare workers if a case of smallpox is reported, or a clearly imminent danger of smallpox transmission is shown to exist."

Virginia Commonwealth University (VCU) Health System in Richmond, Va., also said it would not implement a voluntary program without the presence of at least one of three indicators: a case of smallpox reported anywhere in the world, a report that the smallpox virus had been found outside the two designated repositories in the United States or Russia, or an announcement by the federal government that a "significant threat" of smallpox transmission exists.

"The president has said that none of these indications are present, so we are taking that at face value," says VCU epidemiologist Michael Edmond, M.D., M.P.H. "We don't want to put our workers and patients at risk from this vaccine unless there is an even greater risk of the disease occurring, based on the information we have."

Risks, liability questions

Because the program is voluntary, getting vaccinated is not essentially a condition of employment, raising questions of whether those hurt by the vaccine may receive workers' compensation benefits. Data from the 1960s - the most recent the Centers for Disease Control and Prevention (CDC) can provide - indicate that of the 500,000 volunteers in the initial vaccination group, between seven and 26 will suffer life-threatening consequences, such as brain inflammation, and one or two will die.

Then there's the question of whether volunteers should receive paid leave when sidelined by less serious side effects - and this could translate into large numbers of people. In a government smallpox vaccine trial last year involving 200 young adults, one-third missed at least one day of work or school, 75 had high fevers, and several were put on antibiotics because physicians worried that their blisters signaled a bacterial infection.

In addition, many epidemiologists warn that vaccinated healthcare workers shouldn't return to their jobs during the virus's infectious period - up to three weeks or until the initial scab falls off - because the live virus can be transmitted to others. "The CDC says you don't have to furlough workers after vaccin- ation, but I don't agree," says Dr. Edmond. "The literature shows 85 cases of hospitalized patients who got the virus this way, so this type of transmission does occur."

Another difference is how the general public feels these days about the amount of risk they are willing to shoulder, for themselves and their families. Because pregnant women or those planning to become pregnant cannot be vaccinated, families with newborns or young babies at home are justifiably concerned about the vaccination's potential dangers to them. The CDC also warns that the vaccine is risky to people with skin conditions such as eczema.

Groups weigh in

In mid-January, the Institute of Medicine (IOM) urged a "cautious and deliberate approach" to the issue. The IOM says the CDC should continue pursuing opportunities to deliberate and analyze outstanding issues and concerns to "ensure that the campaign is carried out as safely as possible."

The AAMC's Council of Teaching Hospitals and Health System members see the issue similarly, says Robert Dickler, AAMC senior vice president for health care affairs. "We think our members are in the best position to decide what's right for them," Dickler says. "With all the uncertainty, it is understandable that many of them may want to delay and/or phase in their participation," he adds.

Hospitals beyond teaching hospitals also have noted both sides of the vaccination issue. "The issue has evolved since last summer," says Jim Bentley, senior vice president for strategic policy planning at the American Hospital Association. "Now, there are a whole host of legal and [vaccine] implementation issues." The AHA supports the president's recommendation, Bentley says, but is leaving it up to its members to decide whether to vaccinate. For example, some hospitals may choose not to vaccinate if they are undertaking high numbers of transplants. "Hospitals can decide what's in their best interest," he adds.

The CDC, for its part, recognizes the complex nature regarding the decision that hospitals are facing. "It's the question right now," says Lynn Steele, senior adviser for education and training in the CDC's office of terrorism preparedness and response.

"We understand there are a lot of hospitals with questions and concerns, especially in regards to liability and compensation issues. The CDC is working diligently with the Department of Health and Human Services to address those concerns.

"I would hope that hospitals keep in mind the intent of the program: to have a ready workforce to care for smallpox patients in the event of an attack. By vaccinating response-team volunteers - who have been carefully screened to optimize safety and minimize potential complications - hospitals will be prepared to protect the public," Steele says.

"It is a tough situation [for hospitals] to be in right now," she acknowledges. "The decisions are difficult ones to make, both on an individual, volunteer level and at the hospital level. We're very optimistic that hospitals and healthcare workers will heed the call."

AMCs: First Responders?

Many AMCs nationwide are citing various reasons for their "wait and see" approach. One of the chief concerns is the potential danger posed by the vaccine itself, both to recipients and to patients exposed to a live smallpox virus shed by the newly vaccinated, particularly in settings with high-risk patients such as those with compromised immune systems or under- going transplants.

"Do academic medical centers, in particular, need to be the first responders?" wonders Jon Jackson, senior vice president of University of Kansas Hospital, which is opting out of the vaccine program for now. "We are the organizations that step up to the plate in treating the sickest patients. We operate HIV clinics and trauma centers and burn units. Our patient population is different from community hospitals - [AMCs] are much more at risk from exposure to the smallpox vaccine."

He supports using hospitals with fewer high-risk patients to provide first response. "A number of hospitals in our vicinity are participating, so we feel that is sufficient for the first phase. If something changes, we are prepared to take further action." Other concerns, too, are dampening teaching hospitals' enthusiasm for the vaccine program. "Liability issues need to be addressed," says Jackson. "Our state health department has been unable to provide clear guidance on this because so little information is coming down from the federal government."

A question of resources

Many dissenting hospital epidemiologists are concerned that the White House plan, at best, lacks clarity and at worst, won't work.

The CDC has mandated that state health departments, with CDC guidance, set up vaccination clinics, while the number of sites and volunteers is to be determined in the state plans. States are taking different approaches. In Colorado, the state health department "has been very conservative in the number of people it is recommending" to be vaccinated, says Theodore Eickhoff, M.D., professor of medicine and infectious disease and an epidemiologist at the University of Colorado Health Sciences Center.

The Colorado plan is "user- unfriendly," Dr. Eickhoff says. "It discourages participation because it requires volunteers go to one of only four county health departments in the state. The most effective way of compliance is to take it directly to volunteers, but the state doesn't have those resources." The federal government has not promised extra funding for the vaccination effort, so cash-strapped state health departments may have trouble rolling out the sort of program the White House hopes for.

In Pennsylvania, the state health department is still working on a policy in a climate where "nobody seems to know what they want to do, because the federal guidelines have not been well- defined," says Bernett L. Johnson Jr., M.D., senior medical director for the Hospital of the University of Pennsylvania.

The latest news is that the state plans to vaccinate defined groups of pre- and post-responders, "Although the specifics of their plan have not been divulged," he says. "Our hospital plans to vaccinate a response group of about 200 people as post-event responders, but the specific composition is not fixed, nor is the issue of furlough after the vaccination."

Dr. Johnson adds that vaccinating healthcare providers in the community has not been addressed, even though he believes that in the event of smallpox exposure, it is likely that patients would first present at a physician's office or clinic with a rash. "You would have to immunize dermatologists, family practitioners, and so on to really target those most at risk from initial contact," he says.

Some argue that hospitals owe it to their staff to offer the vaccine to whoever wants it, since they will be among the first exposed in a smallpox outbreak. But there has been little demand from healthcare workers.

"No one is beating down our door to get this vaccine," says Dr. Edmond of VCU. "We have been very public about our policy. As healthcare workers learn more about the vaccine, they are less interested in getting it. Almost everybody does their own risk-benefit analysis in their mind and decides against it. Here is a vaccine for a disease that doesn't exist, but the vaccine virus can be transmitted to people in your household. How many people are willing to accept that?"

AMCs that have balked at the vaccine recommendation have swallowed their share of bad publicity, but are resolute. "Some have said that hospitals should do this from a patriotic or national-security standpoint," he says.

"But I am the hospital's epidemiologist. My responsibility is to protect our workers and patients. At our local level, our hospital serves an inner-city population, including a large number of vulnerable patients. In my mind, the most compelling argument is 'First, do no harm.' That's what it's all about." n

Editor's Note: The CDC has set up a Web site for smallpox vaccine information, www.bt.cdc.gov/agent/smallpox. Managing Editor Michael G. Malloy, mmalloy@aamc.org, contributed to this story.

Contact Us    © 1995-2008 AAMC    Terms and Conditions    Privacy Statement