Smallpox Proposal Raises Ethical Issues

By LAWRENCE K. ALTMAN

TLANTA, June 21 — The decision by a government advisory panel to recommend smallpox vaccination for about 15,000 health care and law enforcement workers raises logistical and ethical issues involving not just the people who will get the vaccine but also those who will come in contact with them.

If experience from the time when smallpox vaccine was routinely administered to the public is a guide, doctors say, some of the 15,000 "first responders" who receive the vaccine may suffer serious — potentially even deadly — complications. Steps may also have to be taken to protect certain people who come in contact with others who receive the vaccine, which infects recipients with live vaccinia virus, a relative of smallpox. Because those vaccinated can shed this virus, they can spread its smallpox protection as well as its complications.

The risk is especially high for people with a history of common skin conditions like eczema and those whose immune systems are weakened by treatment for cancer, infection with the AIDS virus or other conditions. So some doctors say it may be necessary to screen potential recipients before offering them the vaccine.

The panel, the Advisory Committee on Immunization Practices, recommended vaccination for two teams of designated health workers in each state: public health officials who would investigate the initial cases in a smallpox attack and medical personnel in hospitals that government officials would designate to care for smallpox victims.

The number of teams would vary with the population and geography of each state. The plan calls for at least one health care treatment team for every million in population. It was not clear how the policy, if adopted, would deal with workers in these hospitals who chose not to be vaccinated.

Government officials have recommended against widespread vaccination because, in the absence of a known smallpox threat, the vaccine's dangers seem to outweigh its benefits. Smallpox vaccine has a significantly higher risk of serious side effects than other vaccines.

If the panel's recommendations are adopted as policy, the immunizations would be the largest number given in this country since it stopped routine smallpox vaccinations in 1972. Until now, the government has restricted use of smallpox vaccine to scientists who work with smallpox and related viruses in a laboratory. About 11,000 such workers have received the vaccine since 1983, said Dr. Harold Margolis, an official with the Centers for Disease Control and Prevention here.

After the anthrax attacks last fall, the disease centers asked the panel to determine whether more Americans should get the vaccine.

In choosing a relatively small group, the panel did not decide on the logistics for putting the recommendations into effect and left the planning for that up to the government. That, too, will not be an easy task, said the panel's chairman, Dr. John F. Modlin of Dartmouth Medical School. Among problems needing resolution is who will pay compensation to workers who develop vaccine complications.

Dr. Julie L. Gerberding, the acting deputy director of the centers, the federal agency that would have primary responsibility for monitoring the policy, said the C.D.C. would work out the plans "over the next several months."

By early 2003, the government expects to have enough vaccine made from a new technique to protect every American. But until then a high priority is to make sure that available vaccine is used efficiently in case it is needed in an emergency.

Although many states have begun assembling the teams, fall seems the earliest that the first team members would receive vaccinations.

The government owns all smallpox vaccine, which it classifies as "investigational." That means each recipient's written consent would be required after its considerable dangers are explained.

Vaccination will be voluntary, and issues of confidentiality concerning a person's health could pose problems.

"There's no single answer, and the states will have to talk it through," Dr. Margolis said.

Sore arms, swollen lymph nodes and fever can occur in up to 50 percent of recipients. Because the vaccinia is live, it can spread to cause severe skin infections, sometimes destroying tissue and causing permanent disability. Or vaccinia can be spread just to the eye and permanently blind. Vaccinia can also cause brain damage from encephalitis in about 1 in 100,000 vaccination recipients and death in about 1 in 1 million recipients.

Some complications can be modified by injection of a natural substance known as vaccine immune globulin, which is derived from the blood of people who have been vaccinated against smallpox. But there is only enough of the substance to treat about 600 patients.

Although many of the 11,000 vaccine recipients since 1983 have had to stay out of work for a few days, none have needed vaccine immune globulin, Dr. Margolis said.

But when about 125 health workers were vaccinated at the disease centers last fall, doctors who gave the injections were surprised by the number and severity of adverse reactions. Many recipients were treated with antibiotics in the erroneous belief that the site of vaccination had become infected. Older doctors who had given smallpox vaccine in decades past told their younger colleagues that the skin reactions were from the vaccine. Doctors who conducted recent trials to test the safety and effectiveness of diluting the vaccine had a similar experience.

Another potential problem is that a recipient can inadvertently pass on vaccinia to other people who have not consented to a vaccination.

"If you get immunized with vaccinia, you can infect people around you from your vaccinia scab," Dr. Gerberding said. "So while you may accept the risk for yourself, you would be imparting a risk to your contacts."

A question that the panel did not address, but that is likely to arise, is whether to do an H.I.V. blood test before a person is vaccinated.

When the centers immunized a number of workers last fall, the recipients were asked if they were infected with H.I.V., but a blood test was not performed. H.I.V. tests have been required for other smallpox vaccine recipients.