Preparation Used by Military Is Unlicensed, Controversial.

October 27, 2001 – Published as the 1,249th post on the first generation Federal Observer, in the category, To Health With You!, approximately three months from the sites first publication … and so the games continue! ~ Editor

The federal government will begin offering anthrax vaccine as an experimental treatment to thousands of people potentially exposed to the deadly bacteria during a series of attacks this fall, administration officials announced yesterday.

For those wary of taking the controversial, unlicensed vaccine, health officials laid out two alternatives: take an additional 40 days of antibiotics or take no new medicines and wait to see if symptoms arise.

The decision to make the vaccine available as early as today reflects growing unease that antibiotics may not be sufficient protection against a disease that scientists know very little about. Bacteria may survive longer in people”s lungs than 60 days and continue to pose a health threat. The vaccine may enable the immune system to fight off any lingering spores.

“The vaccine used in this way would represent a new way of using vaccine than it has been used before,” said D.A. Henderson, the government’s top bioterror preparedness expert, adding that the risk of anthrax after 60 days of antibiotics was based on slim evidence from animal studies. “This is the best we have to go on.”

On Monday, government anthrax experts urged about 75 congressional aides who were in the proximity of an anthrax-laced letter to begin the three-shot regimen immediately. Officials estimate that about 3,000 congressional and postal workers in Washington, New York and New Jersey may continue to be at risk because they were exposed to high levels of the bacteria. Area postal workers will be briefed on their options within a week.

The vaccine long has been the focus of controversy because of the military’s mandatory vaccination of troops to protect them against biological weapons. Some soldiers refused to get inoculated because they were worried about the vaccine”s safety. Nevertheless, the vaccine has been given to 524,000 military personnel, and officials said it has been shown to be safe. But it has never been administered for post-exposure, therapeutic purposes.

“The decision to use this vaccine is at the discretion of the individual,” Health and Human Services Secretary Tommy G. Thompson said, noting he was taking the unprecedented step “out of an abundance of caution.” However, Thompson’s advisers were reluctant last night to offer concrete guidance to patients on which option to choose, or to specify criteria that should be used to determine who should receive additional treatment.

“In medicine we’re often faced with difficult decisions based on inadequate information; that’s where we are here,” Henderson said.

He and others said the scientific data are limited to a few animal studies that offered conflicting views on how long anthrax spores can survive in the body. In a few instances, spores lurked in monkeys” lungs for 75 and 98 days.

“There is theoretical reason to believe this might – might – provide some benefit,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

Because the vaccine has not been approved for post-exposure treatment, participants will be asked to sign a consent form accepting a battery of potential risks, such as soreness, swelling, headaches, muscle and joint pain, nausea, fever, chills and malaise. Thompson said the government would release the vaccine’s maker, BioPort Corp., from legal liability tied to the program.

Last night, HHS spokesman William Pierce said a CDC institutional review board was finalizing the consent form. Local and postal officials expressed frustration over the lack of information and mixed messages coming from the Bush administration.

“There are a lot of people saying publicly that these spores can exist for up to 100 days and that they are concerned about what that means,” said D.C. Health Director Ivan C.A. Walks. “I’m not sure it means anything. No one is sure it means anything.

“If there were folks who were sure of a significant risk, they would be recommending vaccination,” Walks added.

…but, If it’s free, what’s the cost?

Postal workers were equally dismayed.

“The Food and Drug Administration has not even approved a protocol for dispensing the vaccine yet,” said Postal Service spokeswoman Kristin Krathwohl. “If they”re going to start vaccinating tomorrow, it seems to me that they might need a protocol. . . . A lot of things are unanswered at this point.“

Concern about the unknown effects will weigh heavily on everyone considering the offer, said Olander Williams, a truck driver and a chief shop steward for the motor vehicle section at the Brentwood Road postal facility. He said he has reservations about the vaccine’s safety and is not interested in resuming oral antibiotic therapy, which he quit after a month because of side effects.

“A lot of people think they are experimenting on us and are a little paranoid about the whole ordeal,” he said. “The vaccine is out for me. No way with the vaccine.”

In recent years, the FDA has halted vaccine production at BioPort’s plant in Lansing, Mich., because of improper manufacturing practices.

FDA officials are now racing to finish inspections to issue a license, and they are under intense pressure to issue a favorable verdict, said Rep. Christopher Shays (R-Conn.), who has monitored the company as a member of the military personnel subcommittee of the Armed Services Committee. Shays said yesterday that the company had not addressed fundamental performance questions and that the pressure on the FDA could make its verdict open to question.

“We don’t know if it’s safe and we don’t know if it’s effective,” he said, suggesting that health officials wait a few more weeks to see if BioPort passes its FDA inspection.

Pentagon officials said yesterday that Defense Secretary Donald H. Rumsfeld had authorized the release of 219,000 doses of the vaccine at Thompson’s request on Oct. 24. The Department of Health and Human Services paid the Pentagon $598,000 for the doses.

R. Alta Charo, a professor of law and medical ethics at the University of Wisconsin in Madison, said the vaccination plan was not really experimental, in that its primary purpose was to treat people, not to gain scientific knowledge.

Written by Ceci Connolly and Shankar Vedantam for the The Washington Post. Staff writer Avram Goldstein contributed to this report. ~ October 27, 2001