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DOD CYA Maneuver

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

Comments from Dr. Meryl Nass


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

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