Because we have repeatedly pointed out to Congress and FDA that DOD is not following
the package insert with respect to who should get the vaccine, and who should not get the
vaccine, the Assistant Secretary of Defense for Health Affairs sent out a memo March 10,
2000 (http://www.anthrax.osd.mil/FEATURES/POLICY_medexempt.htm)
to the Surgeon Generals of the three services, telling them basically to follow guidelines
very similar to the package insert (http://www.bioportcorp.com/AnthraxIns.htm)
This is a CYA maneuver. Previous guidelines for waivers and treatment have been
developed by Drs. Pittman and Engler, with the intention of not revaccinating people with
extremely severe vaccine reactions, but those Docs were under the gun to keep as many
people receiving vaccine as possible. Those guidelines were not in accord with the
package insert.
Their guidelines were very restrictive as far as who could receive an exemption and how.
Because the attending physician was not given the authority to exempt his/her own
patients, I had pointed out to the FDA that DOD was usurping the clinical judgment of its
physicians, and it is ONLY the physicians who can legally make the clinical decision of
who should and should not be vaccinated. DOD does not (so far at least) have a
license to practice medicine.
Dr. Bailey now is making a gesture to put the MD back into the picture, since by law this
is required. Yet she doesn't want to allow the MD authority in this area. So a
considerable amount of verbiage is used to confound the issue. (DOD has some
impressive wordsmiths.) Here are her new guidelines, then my comments:
Medical Exemptions.
The granting of medical exemptions is a medical function that can only be performed by a
privileged health care provider. Such individual exemptions should be applied only when
medically warranted, with the overall health and welfare of the patient clearly in mind.
The granting of medical exemptions should be based on potential benefits versus risks and
should always take into consideration the immediate threat assessment.
Temporary medical exemptions are warranted in the five situations listed below.
1.Immunosuppressive Therapy. Individuals receiving systemic corticosteroid
therapy, other immunosuppressive drug therapies, or radiation therapy, may be in a
state of temporary immunodeficiency. Because of potential suppression of the immune
response, these individuals should be deferred from receiving the anthrax vaccine until
immune function returns, as determined by the attending physician.
2.Acute Illnesses. Serious acute diseases or acute injuries may be
potentially aggravated by anthrax vaccination or can lead to more severe side effects with
immunization. This includes any acute febrile illnesses. Vaccinations may resume, as
determined by the attending physician.
3.Post-surgery. Post-surgical situations may warrant temporary vaccination
deferment in order to ensure full recovery through convalescence. The timeframe when
vaccinations may resume following a surgical procedure will be again be determined by the
patient’s attending physician.
4.Pregnancy. Anthrax vaccine should be deferred until after pregnancy.
Because anthrax immunization is largely based on occupational risk, vaccination should
resume with full assumption of duties following pregnancy, unless a longer post-partum
interval is medically indicated, and be in accordance with current DoD and Service
policies.
5.Other Conditions. In situations where a medical condition is in the process
of being evaluated or treated, a temporary deferral of anthrax vaccination may be
warranted. This would include significant vaccine-associated reactions that are being
evaluated. The timeframe for deferral will be determined by the attending physician, and
in accordance with current DoD and Service policies.
Situations warranting a permanent medical exemption include: severe reaction to a previous
anthrax vaccination, where it has been determined that further vaccination will seriously
endanger the health status of the patient; and Human Immunodeficiency Virus (HIV)
infection and other chronic immunodeficiencies, where the immune response may be
unpredictable and such individuals would not be deployed to a high threat area.
If an individual’s case is complex or not readily definable, an
allergist/immunologist, or other appropriate medical specialist, should be consulted
before any exemption is granted. If a permanent deferment from further immunizations is
indicated, appropriate DoD and Service policies will be pursued for the granting of such
exemptions. Medical records will be accurately and appropriately annotated pertaining to
any temporary or permanent exemptions. Health care providers will periodically review
exemptions, to assure that they continue to be valid.
Adverse Events.
As provided in HA Policy No. 99-031, Policy for Reporting Adverse Events Associated with
the Anthrax Vaccine, 15 October 1999, any serious adverse reaction temporally associated
with receipt of a dose of anthrax vaccine should be immediately evaluated by a privileged
health care provider and any specialists, if indicated. The clinical practice guidelines
available on the AVIP web site (www.anthrax.osd.mil).
can also be consulted.
Vaccine Adverse Event Reporting System (VAERS) reports shall be filed using Service
reporting procedures for those events resulting in hospital admission or lost duty time or
work greater than 24 hours or from those events suspected to have resulted from
contamination of a vaccine lot. Further, health care providers are encouraged to report
other adverse events that in the provider’s professional judgment appears to be
unexpected in nature or severity. In other situations in which the patient wishes to
submit a Form VAERS-1 report, the health care provider will assist the patient in
completion of the reporting form. VAERS-1 form reports may be obtained by accessing the
AVIP web site or by calling the FDA at 1-800-822-7967.
These policies are effective immediately and should be communicated to appropriate
commanders, health care providers, and others involved in the implementation of the AVIP.
Dr.
Sue Bailey
cc:
Surgeon General of the Army
Surgeon General of the Navy
Surgeon General of the Air Force
Director of the Joint Staff
1. The person who will make the exemption decision is the "privileged health care
provider." This is terminology I never learned in medical school. Who,
pray tell, will be "privileged?" Is this another attempt to get around the
authority of the attending physician, and designate specific 'anthrax policemen' as the
privileged doctors?
2. Exemptions are temporary, not permanent. Again, the practice of medicine in the
"real world" requires that if a patient has an adverse reaction to a drug or
vaccine, the drug or vaccine is never given again unless the need is life-threatening.
At that point one might try desensitization. The concept of temporary waivers
is ridiculous, way outside standard medical practice. It should be junked.
3. "Situations warranting a permanent medical exemption include: severe
reaction(s)..." I was sent a new (DOD) definition of "severe"
recently. DOD is making up its own definition of 'severe' so that it appears to be
acting within the package insert guidelines, when it has no intention of doing so.
Please remember that severe includes any chronic medical condition such as joint
pain, fatigue, memory loss or tinnitus that results following vaccination. DOD does
not get to rewrite the dictionary, making it nearly impossible to meet their private
definition of severe. If you have a serious reaction, you should be legally exempt
from taking any more vaccine, and if you are having problems in this regard, please post
your problem to the list and we will attempt to assist you. Lawyers are looking into
this now.
4. The 'Adverse Events' section expands on the original restricted reporting stipulations
of the anthrax vaccine implementation plan, but narrows the reporting suggestions of the
more recent document that was written (I think) for Congress and FDA but never intended to
be followed by medical providers. That document suggested that *all* suspected
adverse events be reported to FDA. Which is the correct policy? Why does the
policy keep changing? What is wrong with reporting all suspected reactions to FDA
and letting FDA determine if they are causally related?
Here is a bit of clinical advice that might help someone: Many of the patients I
treat have abnormalities of their hypothalamic/pituitary/adrenal axis. Some receive
low dose steroids and other hormones to treat this problem. Those who receive
steroids (low dose cortisol or prednisone) because of prior illness from the anthrax
vaccine are *ineligible* to receive further doses of anthrax vaccine while on this
medication. Personal physicians may wish to keep this in mind as their patients
attempt to get optimal medical care and avoid further vaccine doses that may cause them
additional harm.
Meryl Nass, MD