CDC's anthrax vaccine trial exclusions tell us CDC knows more about anthrax vaccine reactions than it's telling
CDC began a 1564 person clinical trial of AVA/Biothrax in 2002. The purpose was to identify adverse reactions and get a license change to allow intramuscular injections and fewer doses:
http://clinicaltrials.gov/show/NCT00119067
Somehow, surveillance for adverse reactions turned into a search for primarily local, acute reactions. Nonetheless, there have been over 100 serious adverse events in study subjects, though CDC claims they are unrelated to vaccination.
CDC identified a number of medical illnesses that would lead patients to be excluded as participants. By a strange coincidence, these illnesses are also those that have been reported frequently after anthrax vaccine, as potential adverse reactions. The fact that CDC used them as exclusionary criteria suggests CDC was well aware of what deleterious things anthrax vaccine can do. Perhaps CDC's claim that the serious reactions are unrelated to anthrax vaccine is disingenuous?
Here are some of the exclusions:
1. Moderate to severe asthma
2. Active coronary artery disease
3. Pregnancy or failing to use birth control during the study
4. Active cancer, leukemia or lymphoma
5. Cardiomyopathy or congestive heart failure
6. COPD or other significant pulmonary disease
7. Liver or kidney disease
8. Autoimmune disease
9. Neuropathy or other evolving neurologic condition
10. Mental illness
11. Seizures
Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
207-288-5081 ext. 220
http://clinicaltrials.gov/show/NCT00119067
Somehow, surveillance for adverse reactions turned into a search for primarily local, acute reactions. Nonetheless, there have been over 100 serious adverse events in study subjects, though CDC claims they are unrelated to vaccination.
CDC identified a number of medical illnesses that would lead patients to be excluded as participants. By a strange coincidence, these illnesses are also those that have been reported frequently after anthrax vaccine, as potential adverse reactions. The fact that CDC used them as exclusionary criteria suggests CDC was well aware of what deleterious things anthrax vaccine can do. Perhaps CDC's claim that the serious reactions are unrelated to anthrax vaccine is disingenuous?
Here are some of the exclusions:
1. Moderate to severe asthma
2. Active coronary artery disease
3. Pregnancy or failing to use birth control during the study
4. Active cancer, leukemia or lymphoma
5. Cardiomyopathy or congestive heart failure
6. COPD or other significant pulmonary disease
7. Liver or kidney disease
8. Autoimmune disease
9. Neuropathy or other evolving neurologic condition
10. Mental illness
11. Seizures
Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
207-288-5081 ext. 220
