One small step towards human-animal integration and one giant leap for the FDA
On Monday the Food and Drug Administration (FDA) approved an anthrax vaccine for humans using the treacherous bio-equivalent of the Patriot Act known as theBioterrorism Act of 2002 under the Animal Rule. This Act was passed post-911 and the supposed distribution of anthrax through the mail. The ramifications of this Act have not yet seen the light of day, but with this new regulatory pathway, we will be witnessing a deluge of unconstitutional regulations.
The little known Bioterrorism Act of 2002 is divided into 5 parts:
- National Preparedness for Bioterrorism and Other Public Health Emergencies,
- Dangerous Biological Agents and Toxins,
- Food and Drugs,
- Drinking Water, and
- Additional provisions.
The extent of the Bioterrorism Act of 2002 has been quietly waiting in the wings for execution.
The contract for BioThrax was awarded to Emergent BioSolutions of Gaithersburg, Md.
The FDA approved vaccine under the Animal Rule expedites bioweapon vaccines to market when efficacy cannot be ethically or feasibly tested in humans.
Anthrax is the first to be approved. There are nine other therapies in this new regulatory pathway to combat chemical, biological, and radiological threats using the Animal Rule.
New Vaccination Rules
While the Animal Rule advocates testing vaccines on animals in many cases manufacturers can vaccinate people and then expose vaccinated persons to the virus to see how effective the vaccine will be. This is being considered with the respiratory syncytial virus. What this means is that manufacturers no longer have to test vaccinations and treatments on animals because they can go directly to human trials except for a few of the world’s most lethal pathogens.
The Animal Rule
The Animal Rule has five pillars:
- That the there is a “reasonably well-understood” physical pathway mechanism by a CBRN and a prevention product is possible. Scientific data can be manipulated depending upon your perspective.
- That the vaccine or therapy will react the same in humans and animals, or predicted to respond in humans as it does in animals. Unfortunately, humans and animals do not always react the same.
- The end-point is the desired outcome for humans. This includes survival enhancement or the questionable prevention of morbidity using humansurrogate markers.
- The treatment must determine a human dosage through relevant data. That dosage may be the LD50, the amount to induce a lethal dose.
- As with all federal programs any treatment or vaccine must be conducted in accordance with good laboratory practices (21 CFR part 58) regulations and the Animal Welfare Act (7 U.S.C. 2131 et. seq.), Products evaluated for effectiveness under subpart I of part 314 and subpart H of part 601 will be evaluated for safety under requirements for establishing the safety of new drug and biological products.
Products may be toxic to humans but that data will not be included in the regulatory pathway.
This victory by the FDA further integrates the One Health doctrine of integration between human and animal medicine. In the eyes of the FDA you are an animal to be experimented on with or without your consent.
New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible, Federal Register, Vol. 67, No. 105, Friday, May 31, 2002. (Federal Register notice)