In December 2005, the U.S. Food and Drug Administration (FDA) released its Final Order on anthrax vaccine, declaring it to be 92.5 percent effective for preventing both inhalation and cutaneous anthrax infections.

Nearly two years ago, Congress asked the National Academy of Sciences (NAS) to review the existing data on safety and efficacy of the anthrax vaccine (AVA).  A committee was created by the NAS Institute of Medicine (IOM) to do this, and the group met over the last seventeen months to review this complex and controversial issue.

Judge Puts Halt On Anthrax Vaccinations

As usual, the Department of Defense (DOD) and its Assistant Secretary of Defense for Health Affairs, Dr. William Winkenwerder, have decided not to tell the whole truth about the anthrax vaccine program.

Although the DOD might wish the judge’s ruling was temporary, like the temporary restraining order issued by this judge in December 2003, the ruling is explicitly permanent.

Did you think the FDA’s job IS to protect the public from dangerous drugs and vaccines? Well, yes, sometimes…as long as the federal government doesn’t want to administer those self-same dangerous products.

FDA has been helped along by the 1997 FDA Modernization Act (FDAMA), which lowered the evidence bar for new drug approvals,

My comments are interspersed within this item, found in the MMWR (November 15, 2002), a CDC publication. The ACIP is a CDC construct (supposedly independent but not really--the same group that said only 15,000 Americans should get smallpox vaccine at first, then changed their recommendations to make them more in line with government desires.)

From The Frying Pan Into The Fire?

The NIH has contracted with two private companies for a new anthrax vaccine for civilians. Twenty-five million dollars has been allotted for this in the current federal budget. The Pentagon contracted with Dynport Corporation for a new military anthrax vaccine. Implicit in these negotiations is

A Story About Hope, Recovery And Autism

Here are the tears of things: mortality touches the heart
Virgil

Anyone who has lived through the horror of watching a loved child fade slowly, in shades of gray, into a ghost, knows the devastation of autism.

MORE HUMAN GUINEA PIGS AND MORE HARM

When an announcement comes out of the Pentagon at 4 pm on a Friday, you know it’s something they are trying to bury. This Friday, it was the long-awaited announcement about what was to happen to the anthrax vaccine immunization program.

WHY? WERE THE LETTERS AN OFFICIALLY APPROVED WAKE-UP CALL TO THE BIOWARFARE THREAT?

Are you picking up on all the weird press on anthrax lately?

CURRENT ACTIONS SUGGEST IT IS NOT!

The attacks of September 11 and the anthrax letters which followed, led to tremendous concern about a biological or chemical assault on the United States. An Office of Homeland Security was created, and the US rushed the creation of a chemical and biological defense infrastructure. Over $9 billion was allocated for research and training in biological defense, and the development and stockpiling of vaccines and other treatments for anticipated threat agents.

SO MANY OBSTACLES, SO LITTLE COMMITMENT

This week I got calls from two people, unknown to each other, who had developed pemphigus vulgaris after receiving anthrax vaccine. Pemphigus vulgaris (which I’ll call PV for short) is a rare autoimmune disease in which thin-walled blisters form on the skin and mucous membranes, caused by antibodies that bind to the skin cells which then separate from each other. In the past it was 60% to 90% fatal, but now, with the wonders of steroids and immunosuppressants, it is only about 10% fatal. (The 10% includes those who die from side effects of the treatment.) PV most commonly occurs in the elderly. The two people I spoke with were in their twenties and thirties.

THIS IS NOT A HEALTHY PIECE OF LEGISLATION

One year ago, the Centers for Disease Control began negotiations for a model piece of legislation that would help states deal with a bioterrorism epidemic. Why focus on the states rather than the federal government? Because control of the practice of medicine is regulated at the state, not federal level. Some emergency responses are also handled at the state level, such as disasters in which the national guard (really a state militia) is called to assist. Other preparations for emergencies are made at the federal level.

Following Valuable Clues

"Senior Bush administration officials have privately said that little progress is being made in the anthrax investigation, which has involved hundreds of investigators, [who] are no closer to finding the culprit, they say." So reported Todd J Gillman and Michelle Mittelstadt of the Dallas Morning News on January 31.

The Offical Response To Bioterrorism

Former Defense Secretary William Cohen had said, "It’s not a question of if, but when." The phrase became a mantra in the military and halls of Congress.

A Survival Guide

Thousands of people were exposed to potentially lethal anthrax spores in the last two to three months. Those who are known to have inhaled spores were given antibiotics to prevent infection.

What Do We Really Know About Safety?

Responding to recent anthrax events, CDC has offered anthrax vaccination to people who were exposed to large doses of anthrax spores, and who are completing 60 days of antibiotics. However, there exist no human efficacy studies for this vaccine, and the data regarding safety are confusing.