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Docket No. ND02-01188

DEPARTMENT OF THE NAVY
 NAVAL DISCHARGE REVIEW BOARD (NDRB)
                     DISCHARGE REVIEW
                   DECISIONAL DOCUMENT

 ex-ET3, USN
Docket No. ND02-01188

Applicant’s Request

The application for discharge review, received 020820, requested that the characterization of service on the discharge be changed to honorable.  The Applicant requested a documentary record discharge review.  The Applicant did not designate a representative on the DD Form 293.

Decision

A documentary discharge review was conducted in Washington, D.C. on 030515.  After a thorough review of the records, supporting documents, facts, and circumstances unique to this case, NDRB discerned no impropriety or inequity in the characterization of the Applicant’s service.  The Board’s vote was unanimous that the character of the discharge shall not change.  The discharge shall remain: GENERAL (UNDER HONORABLE CONDITIONS)/MISCONDUCT, authority: NAVMILPERSMAN, Article 1910 - 142 (formerly 3630605).

PART I - APPLICANT’S ISSUES AND DOCUMENTATION

Issues, as submitted

Hello, my name is A_ D_ (Applicant) and I was separated from the United States Navy for refusing to take the Anthrax Vaccine.  The following statement contains the specific issues for Block 8 of the DD FORM 293, APPLICATION FOR THE REVIEW OF DISCHARGE OR DISMISSAL FROM THE ARMED FORCES OF THE UNITED STATES:

The Anthrax Vaccine became mandatory because the Department of Defense felt that anthrax, produced into aerosolized anthrax and used as a Biological Weapon, was a viable threat to our military service members, and that the best protection would be immunity.  While this sounds to be a good idea, a plan was set forth to inoculate millions of service members with a shot that was approved for cutaneous anthrax in 1970, not aerosolized anthrax, manufactured from a company that has had many problems meeting standards set by the FDA and on more than one occasion has been formally warned by the FDA of its intention to revoke the license to produce the vaccine, been cited numerous times of quality control and production problems during inspections, many of which were not resolved from previous inspections, and that it has not been scientifically tested for side effects.

This list can go on and on, so here is a listing of the main issues I want to be studied and considered:

1.	A drug is considered to be an Investigational New Drug, or IND, even if it has been used for years if:

1)	There is a proposed change in the target us of the product
2)	A change in the formula
3)	Dilution of the drug
4)	A change in the route of administration
5)	A change in the dosage
6)	Repackaging of the drug product
7)	Drugs not adequately tested
a)	substantial evidence consisting of adequate and well controlled investigations, including clinical investigations conducted by experts
See Documents 1, 4, 21

2.	The Anthrax Vaccine ordered by the Department of Defense to be given to U.S. military members is an IND:
1)	The approved license for anthrax was for a prophylaxis only against cutaneous exposure to anthrax.  The military is using it for pulmonary infections. (See Documents 1, 3, 21, 23)
2)	The chemical makeup of the current anthrax shot is NOT the same as the one licensed in 1970, and the manufacturing process has changed. (See Document 21)
3)	In 1996, Michigan Biologic Products Institute (MBPI) filed an IND application to the FDA showing a designation for'inhalation anthrax', changing the 'route of administration', and changing the 'vaccine schedule'. (See Documents 5, 6)
4)	The vaccine has a lack of testing to prove if it is both safe and effective for the DOD's use. (See Documents 5, 16, 17, 22, 24,
25)

3.	The use of an IND on military members is illegal unless a waiver is signed by the President, or by the individual taking the vaccine:

Federal Statute 10 U.S.C. 1107 (1999) Entitled "Notice of use of an Investigational New Drug or a drug unapproved for its applied use" states:

a.	Notice required: (1) Whenever the Secretary of Defense requests or requires a member of the armed forces to receive an Investigational New Drug or a drug unapproved for its applied use, the Secretary shall provide the member with a notice containing the information specified in subsection (d)
b.		…. 
c.	….
d.	Content of Notice- The notice in subsection (a)(1) shall include:
1)	Clear notice that the drug being administered is an Investigational New Drug or drug unapproved for its applied use
2)	The reason why the Investigational New Drug or drug unapproved for it applied used is being administered
3)	Information regarding the possible side effects of the Investigational New Drug or drug unapproved for its applied use including any unknown side effects possible as a result of the interaction of such drug with other drugs or treatments being administered to the members receiving such drug
e.	Limitation and Waiver- In the case of the administration of an Investigational New Drug of drug unapproved for its applied use to a member of the armed forces in connection with the member's participation in a particular military operation, the requirement that the member provide prior consent to receive the drug in accordance with the prior consent requirement imposed under section 505 (i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) may only be waived by the President.  The President may grant such a waiver only if the president determines, in writing, that obtaining consent:
1)	Is not feasible
2)	Is contrary to the best interest of the member, or
3)	Is not in the interests of National Security
See Documents 1, 9, 10, 11, 12, 13, 21, 22

4.	Secretary Cohen set four conditions on the start of vaccinations:

1)	Supplemental testing to assure sterility, safety, potency, and purity of the vaccine stockpile
2)	Implementation of a system for fully tracking anthrax immunizations
3)	Approval of operational plans to administer the vaccine and connnunications plans to inform military personal
4)	Review of medical aspects of the program by an independent expert.
See Document 25

5.	The original anthrax vaccine was obtained by the Michigan Department of Public Health (now Bioport) in 1970, two years before efficiency and safety data were required by the FDA for drug approval and licensing.  Long term data for safety was not supplied with the original license application and none has ever been supplied to the FDA. (See Documents 1, 2 1)

6.	The Anthrax Vaccine has NOT been scientifically proven to protect against aerosolized anthrax, and its side effects are not known:

Executive Order 13139:
Sec 2- Administration of Investigational New Drugs of Members of the Armed Forces in part says
... When the Secretary considers an IND or drug unapproved for its intended use to represent the most appropriate countermeasure, it shall be studied through scientifically based research and development protocols to determine whether it is safe and effective for its intended use. (See Documents 16, 17, 22, 24, 25)

7.	The DoD recognizes the vaccine's untested efficiency and still administers the shot. (See Documents 7, 8)

8.	The expert tasked by the Navy to fulfill Secretary C_'s condition was a gynecologist.  In fact, he specifically told the military in writing that he was not an expert on anthrax. (See Documents 15, 25)

9.	The govemment's only source of the vaccine has had many problems ranging from quality control problems and notices from the FDA of intention to revoke the anthrax vaccine license to being unstable at best to supplying an adequate amount of the vaccine.  The administration of the vaccine is a very rigid but long schedule (6 shots in an 18 month period) so the instability of the supply jeopardizes the military's ability to follow the schedule. (See Documents 17, 18, 25)

10.	On the product insert that comes with the vaccine, it states:
30 % of recipients should experience a mild local reaction
4% should experience a moderate local reaction

.2% should experience systemic reactions characterized by malaise and
lassitude with chills and fever
In a survey conducted in calendar year 2000 of National Guard and Reserve Forces, it was reported that 85% had some sort of reaction.
76.2% had local reactions
23.8% had systemic reactions
9 to I 1% had chills and fevers
This shows that the reaction rate is expected to be much higher than the product insert. (See Documents 1, 3, 19, 20)

11.	The government's use of a drug that has never been proven effective against aerosolized anthrax may be properly construed as a large scale test which is against Nuremberg Code 50 U.S.C. 1520a:

c.	Informed consent required- The Secretary of Defense may conduct a test or experiment described in subsection (b) of this code only if informed consent to the testing was obtained from each human subject in advance of the testing on that subject.
See Document 17

12.	A Citizen Petition has been filed against the vaccine. (See Document 24)

13.	The Anthrax Vaccine is under study by the National Academy of Sciences Institute of Medicine to see if there is a connection to the Gulf War Syndrome. (See Document 25)

In closing, I feel that the anthrax vaccine at best is very questionable, no
matter how well intentioned.  It is a drug unproven to protect against aerosolized anthrax, a drug not proven to be safe, and this topic is on every service members mind.  Refusing to take the Anthrax Vaccine was a decision based on moral values, scientific evidence, and the law.

I also want to point out that I have innnediately made a large impact at the first civilian company that I worked for, Marians CableVision out of Guam, and now I work for a Govenunent contracted company called Rome Research Corporation.  This business has taken over a SATCOM facility formerly ran by the Navy so in essence, I am a civilian doing what I did while I was serving in the military.  I hold a secret clearance.
I feel the documentation I have submitted in my package is enough proof that 1, and anyone else in my position, has a legitimate argument against taking the anthrax vaccine.  I have proven myself to be of the highest character and have earned my way in this society.  I hope you feel the same way.

Very Respectfully, (Signed by A_ C. D_ (Applicant))

Documentation

In addition to the service record, the following additional documentation, submitted by the Applicant, was considered:

Table of Contents
Copy of DD Form 214
Declaratory Judgement (District Court for the District of Columbia
Information paper on the Anthrax Vaccine Immunization Program
Jan 31, 2002 revision to the Product Insert 
21 C.F.C. 312.3
1996 IND (Investigation New Drug) application
1998 and 1999 IND application update
1985 DoD request for new vaccine
1995 DoD document documenting knowledge of experimental use
Executive Order 13139
U.S.C. Title 10, Subtitle A, Part II, Chapter 55, Sec 1107; Notice of use of an investigational new drug or a drug unapproved for its applied use
FDA/ORA CPG 7132.12 Sec 400.200
H.R. 3460; Prohibits Sec of Defense to administer an IND
H.R. 2543; Directs Sec of Defense to make the AVIP voluntary
CBER papers showing FDA intention to revoke license, and a voluntary recall of Anthrax Vaccine Adsorbed.
Letter from Dr. B_ to Congressman S_
IOM assessment of vaccine
GAO-Anthrax Vaccine Safety and Efficacy Issues
GAO-Anthrax Vaccine Changes to the Manufacturing Process
GAO-Anthrax Vaccine Preliminary Results of GAO's survey of Guard/Reserve Pilots and Aircrew Members
Statement of Rep. C_ S_
Legal Memorandum
Letter from R_ B_ to B_ A. S_
Summary of 1998 FDA inspection and 10/87 Product Insert

PART II - SUMMARY OF SERVICE

Prior Service (component, dates of service, type of discharge):

	Inactive: USNR (DEP)	960224 - 960821	COG
	Active:   None

Period of Service Under Review:

Date of Enlistment:  960822		Date of Discharge:  991006

Length of Service (years, months, days):

	Active:    03  01  15
	Inactive:  None

Age at Entry:  18			Years Contracted:  4 (24 months extension)

Education Level:  12			AFQT:  84

Highest Rate:  ET3

Final Enlisted Performance Evaluation Averages (number of marks):

Performance:  4.0 (1)	Behavior:  3.0 (1)		OTA:  3.43  (5.0 eval)

Military Decorations:  None

Unit/Campaign/Service Awards:  AFEM, Expert M-16 Medal

Days of Unauthorized Absence:  None

Character, Narrative Reason, and Authority of Discharge (at time of issuance):

GENERAL (UNDER HONORABLE CONDITIONS)/MISCONDUCT, authority:  NAVMILPERSMAN, Article 1910-142 (formerly 3630605).

Chronological Listing of Significant Service Events:

990406:	Applicant requested to be exempt from taking the Anthrax Vaccine, which was subsequently denied on 990406.

990417:	NJP for violation of UCMJ, Article 92:  Failure to obey an order and or regulation.  (Refused: SECNAVINST 6230.4 Department Of the Navy Anthrax Vaccination).
	Award:  Forfeiture of $626.40 per month for 1 month, restriction and extra duty for 30 days.  No indication of appeal in the record.

990801	Applicant notified of intended recommendation for discharge with a characterization of general (under honorable conditions) by reason of misconduct due to commission of a serious offense.  
	[extracted from CO’s letter]

990819:	Commanding Officer, USS HARPERS FERRY (LSD 49), recommended Applicant's discharge by reason of misconduct due to the commission of a serious offense, to wit: having conducted himself in a manner in opposition of command and naval policy.  Commanding Officer’s comments:  “ET3 D_ (Applicant) is a diligent worker and intelligent young man.  Although he has received both counseling and a plethora of information concerning Anthrax, he remains determined not to accept the vaccination.  Recent assessments identifying anthrax as the primary biological threat facing American service men and women today cite this force-wide protective measure as the only way to ensure adequate defense against a threat which is lethal to unprotected individuals exposed to concentrations of the agent.  This leads me no choice but to state that it would be in the best interests of this command and Navy for [ET3 D_ (Applicant)] to be discharged from Naval Service, due to his inability to be worldwide available.”

990928:	CNPC directed the Applicant's discharge with a General (Under Honorable Conditions) by reason of misconduct due to the commission of a serious offense.

PART III – RATIONALE FOR DECISION AND PERTINENT REGULATION/LAW

Discussion

The Applicant was discharged on 991006 with a General Under Honorable Conditions for misconduct due to commission of a serious offense (A).  The Board presumed regularity in the conduct of governmental affairs (B).  After a thorough review of the records, supporting documents, facts, and circumstances unique to this case, the Board found that the discharge was proper and equitable (C and D).

Issue 1.  The issues you raise regarding the legality and safety of the Department of Defenses’ (DOD) Anthrax Vaccination program are beyond the purview of the NDRB to address.  DOD has determined that personnel whose duties are essential to mission critical capabilities are vaccinated against anthrax, both for their personal protection and for success of the military mission.  The NDRB has no authority to question this determination by DOD.  In it’s review of cases, NDRB is required to adhere to the policies and regulations established by the Department of Defense in determining the propriety and equity of a discharge.  In cases involving separation where the member refused the anthrax vaccination, NDRB review is limited to a determination as to whether the member’s case was procedurally correct, and whether his case received the same disposition as those similarly situated.  In your case, the NDRB found that your case was processed in accordance with established procedure and that your discharge was equitable.  In this regard, a characterization of service of general (under honorable conditions) was warranted since your record of service constituted a departure from that expected of a Sailor in the U.S. Navy.  The record does not contain any evidence that you were not responsible for your actions or should not be held accountable.  The award of NJP was proper and equitable; and upgrade to honorable would be inappropriate.  Relief is denied.

There is no law, or regulation, which provides that an unfavorable discharge may be upgraded based solely on the passage of time, or good conduct in civilian life, subsequent to leaving the service.  However, the NDRB is authorized to consider outstanding post-service factors in the recharacterization of a discharge, to the extent that such matters provide a basis for a more thorough understanding of the Applicant’s performance and conduct during the period of service under review.  Verifiable proof of any post-service accomplishments must be provided in order for the Applicant to claim post-service conduct and behavior as a reason to upgrade a less than honorable discharge.  Evidence of continuing educational pursuits, a positive employment record, documentation of community service, and certification of non-involvement with civil authorities, are examples of verifiable documents that should be provided to receive consideration for relief, based on post-service conduct.   

The Applicant remains eligible for a personal appearance hearing, provided an application is received, at the NDRB, within 15 years from the date of discharge.  The Applicant can provide additional documentation to support any claims of post-service accomplishments at that time.  Representation at a personal appearance hearing is recommended but not required.

Pertinent Regulation/Law (at time of discharge)

A.  Naval Military Personnel Manual, (NAVPERS 15560C), Change 18, effective 
12 Dec 97 until 29 March 2000, Article 1910-142  [formerly 3630605]. SEPARATION BY REASON OF MISCONDUCT- COMMISSION OF A SERIOUS OFFENSE.

B.  Secretary of the Navy Instruction 5420.174C of 22 August 1984 (Manual for Discharge Review, 1984), enclosure (1), Chapter 2, AUTHORITY/POLICY FOR DEPARTMENTAL DISCHARGE REVIEW.  

C.  Secretary of the Navy Instruction 5420.174C of 22 August 1984 (Manual for Discharge Review, 1984), enclosure (1), Chapter 9, paragraph 9.2, PROPRIETY OF THE DISCHARGE.

D.  Secretary of the Navy Instruction 5420.174C of 22 August 1984 (Manual for Discharge Review, 1984), enclosure (1), Chapter 9, paragraph 9.3, EQUITY OF THE DISCHARGE.

PART IV - INFORMATION FOR THE APPLICANT

If you believe that the decision in your case is unclear, not responsive to the issues you raised, or does not otherwise comport with the decisional document requirements of DoD Directive 1332.28, you may submit a complaint in accordance with Enclosure (5) of that Directive.  You should read Enclosure (5) of the Directive before submitting such a complaint.  The complaint procedure does not permit a challenge of the merits of the decision; it is designed solely to ensure that the decisional documents meet applicable requirements for clarity and responsiveness. You may view DoD Directive 1332.28 and other Decisional Documents by going online at "afls14.jag.af.mil".

The names, and votes of the members of the Board are recorded on the original of this document and may be obtained from the service records by writing to:

		Naval Council of Personnel Boards
		Attn:  Naval Discharge Review Board
		720 Kennon Street SE Rm 309
		Washington Navy Yard DC  20374-5023

The remaining portion of this document is divided into 4 Parts: Part I - Applicant’s Issues and Documentation, Part II - Summary of Service, Part III – Rationale for Decision and Pertinent Regulation/Law, Part IV - Information for the Applicant.
INDEX:   A6730/A9401/A9445/A9217/A9223/A9221