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http://www.nytimes.com/2002/06/20/health/20SMAL.html

Panel Debates Revising U.S. Policy on Smallpox Shots

By LAWRENCE K. ALTMAN

TLANTA, June 19 — On the eve of a planned vote on whether to change the government's recommendations on smallpox vaccine, a national advisory panel struggled today to determine what is the actual risk of a bioterrorist attack with smallpox.

"We now know we have enemies with the intent to inflict harm and we know that we are vulnerable," said Dr. John F. Modlin of Dartmouth Medical School, the panel's chairman. "What we don't know is what the capability of these individuals may be."

The last case of smallpox in the United States occurred in 1949, and no case of the disease has been identified anywhere in the world since 1978. The United States stopped routine smallpox vaccinations in 1972, leaving most Americans susceptible to smallpox infection if a terrorist released the virus.

After the anthrax attacks last fall, the Centers for Disease Control and Prevention asked a 14-member panel to determine whether changes were needed in the recommendations it made last year. Current recommendations limit smallpox vaccine to scientists working with smallpox and related viruses in a laboratory.

The panel, the Advisory Committee on Immunization Practices, was asked whether all Americans should be allowed to get smallpox vaccine if they wanted it. The panel was also asked whether to limit the vaccine to certain groups like health and emergency-response workers who very likely would be the first to care for anyone who developed smallpox from a bioterrorist attack.

Dr. Modlin said that to his knowledge this was the first time that the panel, which meets regularly throughout each year, had devoted an entire meeting to one vaccine. The panel had been scheduled to vote in late summer, but the government asked for a speedier decision.

The government has called the risk of an attack with smallpox virus low and said that its request did not reflect new information.

But Dr. J. Donald Millar, a former head of the smallpox eradication program at the centers, said health officials and other experts like himself could not determine the extent of the risk of a smallpox attack, and he challenged the government to provide its evidence.

Dr. Millar, who is not a member of the panel, was invited to speak at the public hearing. He said the panel's recommendation "hinges on one question: Is the threat real or not?"

"Our government leaders are very coy about this," Dr. Millar said, adding that the government has sometimes acted as though the threat was real and at other times as though it was imaginary. "We are entitled to all the facts" to make a sound decision, Dr. Millar said.

Bill Pierce, a spokesman for the Department of Health and Human Services, the centers' parent, said his department was not an intelligence agency and had requested the review of smallpox vaccination policy because it was prudent to be prepared even if the risk was low.

In recent weeks, the panel has heard health workers and members of the general public express their views about changing recommendations for smallpox vaccination.

The vaccine can lead to serious and potentially fatal complications like brain damage to recipients as well as to people with whom they come in contact. While smallpox vaccine led to the eradication of a disease for the first time, it is also considered the most dangerous of all immunizations and is unusual in that the risks of complications from a vaccination can be transmitted to a person who did not receive it.

Among those at risk are people whose immune systems have been weakened by the AIDS virus or treatment for cancer. An estimated 28 million Americans with a history of eczema and other skin conditions called atopic dermatitis are also at risk of serious complications from smallpox vaccine.

Some complications can be modified by injection of a natural substance known as vaccine immune globulin that is derived from the blood of people who have been vaccinated against smallpox. But there is only enough of the substance to treat about 500 patients. The scarcity of the substance is a major factor weighing against mass smallpox vaccination.

There is no proven effective therapy once someone becomes sick from smallpox.

The panel's recommendations will be sent to the acting director of the centers, Dr. David Fleming, and then forwarded to Tommy G. Thompson, the secretary of health and human services. The recommendations could also be sent to the White House.

Dr. Dixie E. Snider, an official at the centers and the executive secretary of the panel, said that in the past the panel's recommendations had not been rejected, though the language had been modified in a few cases.

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