FDA uses ‘animal’ rule to approve anthrax vaccine for humans.

by | Dec 8, 2015 | Health | 0 comments

The FDA has dramatically expanded the permitted uses of the anthrax vaccine using a post-9/11 law known as the Bioterrorism Act of 2002. A clause of that act, known as the Animal Rule, allows the FDA to bypass human studies of drugs in cases where exposing humans to a disease or toxin would be unfeasible or unethical.

The rule is intended for highly lethal diseases such as anthrax or Ebola. It does not necessarily have to be limited to diseases that might be used as biological weapons.

The Animal Rule has only been invoked nine times before, and never for a vaccine.

Dead rabbits plus human antibodies = evidence?

The FDA actually first approved the anthrax vaccine – manufactured by Emergent BioSolutions – in 1970, but only to protect people at high risk of exposure. The new approval allows the vaccine to be given to people aged 18 to 65 known or suspected to have already come into contact with the anthrax bacteria. The vaccine should be given in addition to, rather than instead of, the currently recommended course of antibiotics, the FDA said.

There have been no suspected cases of anthrax exposure in the United States since 2001, in which anthrax-laced letters were sent to politicians and media outlets, leading 17 people to become sick. In that case, doctors used the anthrax vaccine off-label in the fashion now approved by the FDA. Five people still died.

To justify the new approval without human studies, researchers decided that a 70 percent survival rate in rabbits would constitute a “reasonable level of protection.” So researchers exposed rabbits to anthrax, then treated them either with only antibiotics or with antibiotics plus the vaccine. Between 70 and 100 percent of the rabbits in the vaccine group survived, compared with 23 to 44 percent in the antibiotic only group.

The researchers then gave healthy humans the anthrax vaccine in three separate doses two weeks apart. At the end of that time, more than half of the participants showed antibody responses similar to those seen in rabbits with a 70 percent survival rate.

On this tenuous basis, the FDA has concluded that the vaccine should be just as effective in human beings as it was in rabbits.

The FDA approval makes a number of large assumptions, but these assumptions will not be put to the test unless and until there is cause to use the vaccine in the newly approved fashion. And with anthrax remaining thankfully rare, there may never be enough data to actually know whether the vaccine works as promoted, or whether it has any unusual side effects in those already exposed to the disease.

Although it is called the “Animal Rule,” suggesting that only animal tests are done, in fact the humans who receive the vaccine are also being experimented on.

Expect more untested drugs to be forced through

The FDA appears to be ramping up its use of the Bioterrorism Act in general, and the Animal Rule in particular. The Animal Rule’s first use, in 2003, was to approve a new pretreatment against nerve gas. No new Animal Rule approvals came until 2006, with a drug for cyanide poisoning. This was followed by a six-year gap.

Then 2012 saw two further approvals, while 2013 saw only one. But this year has seen six, including the anthrax vaccine.

Most uses of the Animal Rule have involved approving new antibiotics to treat anthrax or plague. Two uses involved approving drugs to treat people following nuclear incidents, and one involved a new treatment for botulism toxin.

Use of the Animal Rule to push through untested drugs will likely only continue to accelerate. According to Amesh Adalja of the UPMC Center for Health Security in Baltimore, each FDA approval using the Animal Rule makes it easier to obtain the next.

Sources for this article include:





This article originally appeared at: Natural News



Ceribalius is a pseudonym used by one of our writers, he/she is a digtial nomad and dedicated fighter of freedom and liberty. If there is something that needs saying which no one else is, he/she is the one to do it.
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