STATEMENT
OF
JOHN J. MICHELS, JR.
Mr. Chairman, distinguished members of the Committee, I want to thank
you for the opportunity to address you today on an issue that I believe directly affects
our most important national security resource, the men and women of our Armed Forces. The mandatory anthrax vaccination program, or
AVIP, has not only failed in its stated goal of providing adequate protection to all
members of the active duty and active reserve forces, but has caused many service members
to question whether their civilian and military leadership has their best interest at
heart.
For the Committee’s
information, I would like to provide a brief personal history. I graduated from the United States Air Force
Academy in 1977 and attended navigator and electronic warfare officer training. Following an initial assignment to long range
reconnaissance aircraft for the Strategic Air Command, I was selected to attend law school
under an Air Force program and entered Duke University in 1982. Following law school, I became a member of the Air
Force Judge Advocate General’s Department and served in various JAG assignments until
I left active duty in 1991. Since leaving
active duty I have been in private practice with the law firm of McGuireWoods. I am currently a Lieutenant Colonel in the Air
Force Reserve. I am testifying in my personal
capacity today.
I am not a specialist
in medical law, but got involved in the anthrax vaccination issue when a friend asked me
to assist him in the representation of Air Force Major Sonnie Bates. You may remember Major Bates as the most senior
Air Force officer to refuse the anthrax shot. My
colleague, Air Force Reserve Major Bruce Smith and I prepared Major Bates’ defense
and researched the defenses to the charge of violating a lawful order. Our research uncovered the fact that the
manufacturer of the vaccine, Michigan Biologic Products, Inc., filed an investigational
new drug (“IND”) application with the Food and Drug Administration (“FDA”)
for the vaccine in 1996. This fact, when
coupled with the legal requirements of 10 U.S.C. § 1107 and Presidential Executive Order
(“E.O.) 13139, both of which prohibit administration of an investigational new drug
to members of the Armed Forces without their informed consent, renders illegal orders to
take anthrax vaccine absorbed (“AVA”) shots.
The purpose of my testimony today is to explain why orders to take the vaccine are
illegal under military law.
I. The
Illegal Orders
The key to understanding why the AVA vaccinations are illegal revolves
around the status of the vaccine as an IND. The
term “IND” is a term of art under FDA regulations and refers to a status given
to a substance for which FDA approval is being sought for, among other things, how the
substance is used, a change in formulation, a change in route of administration, or
repackaging. See 21 C.F.R. § 312
(1999).
The term “IND” also embraces so-called “new” drugs
as defined by the FDA itself. See 21
C.F.R. § 312.3(b) (cited in E.O. 13139). A
drug is considered a “new” drug, even if it has been in use for years, if there
is a proposed change in the use of the product, a change in its formulation or dilution,
or changes similar to those required for an IND application.
A variety of court decisions validate FDA’s requirement that “new”
drugs are not licensed and must seek separate FDA approval.
See e.g., Hoffman v. Sterling Drug, Inc., 485 F.2d 132 (3rd
Cir. 1973) (marketing a drug previously approved by the FDA for the treatment of malaria
as suitable for treating lupus caused the already approved drug to be considered a “new
drug” as far as the lupus treatment was concerned); U.S. v. Articles of Drug, etc.,
442 F. Supp. 1236 (S.D.N.Y. 1978) (a drug may be considered “new” if there is a
change in the dosage, or method of administration or application, or other condition of
use prescribed, recommended or suggested in the labeling of such a drug, even if the drug
has previously been approved with a different dosage and for a different purpose). Accordingly, federal statutes, regulations and
case law show that even an established and licensed drug such as the AVA that is modified
with regard to its dosage regimen or purpose for which it is being offered is an “IND”,
and therefore covered by the requirements of
Executive Order 13139 and 10 U.S.C. § 1107.
A.
The AVA has been placed in IND status by its manufacturer in order to
receive FDA approval for using the AVA to protect against inhalation anthrax.
The license for the AVA, approved in 1970 by the National Institute of
Health, indicates that it was approved as a prophylaxis against anthrax resulting from
contact with animal products such as hides, hair, or bones which comes
from anthrax endemic areas that may be contaminated with Bacillus anthracis spores; and for individuals
engaged in diagnostic or investigational activities which may bring them into contact with
B. Anthracis spores… it is also
recommended for high risk persons such as veterinarians and others handling potentially
infected animals.
Anthrax Vaccine Adsorbed, Package insert, Michigan Department of Public
Health (“MDPH”), October 1987.
Because the AVA license contained no specific indication for inhalation
anthrax, in 1995 the owner of the vaccine, MDPH, and the United States Army discussed
establishing a plan for FDA approval of an inhalation anthrax indication. In October 1995 the Joint Program Manager for the
DoD Biological Defense program attended an information meeting prepared by defense
contractor Science Applications International Corporation (“SAIC”) to discuss a
plan. The purpose of the SAIC meeting was to
provide the Director, Medical Biological Defense Research Program with a
project plan to obtain an amendment to the Anthrax Vaccine product license… [to]
obtain indication for protection against aerosol exposure.
See Anthrax Vaccine License Amendment Project Plan briefing slides
(October 20, 1995).
Documents attached to the briefing slides show clearly that the plan in
the fall of 1995 was to get FDA approval to change the immunizational schedule (in this
case from a series of six prescribed doses to three doses), and to change the vaccine
labeling to reflect that the vaccine was properly administered as protection against
pulmonary anthrax. Id.
Minutes of the October 1995 meeting also reflect that the focus of the
project was to obtain a label indication change concerning the prevention of pulmonary
anthrax. The meeting ended with Brigadier
General Walter L. Busbee, Joint Program Manager for Biological Defense, U.S. Army,
directing that participants were to continue the process of developing “an option
package for initiating and completing amendment to the… anthrax license for: (1) a reduced immunization schedule, (2)
immunization by the intramuscular route, and (3) indication for protection against an
aerosol challenge.” Minutes of the
Meeting on Changing the FDA License for the MDPH Anthrax Vaccine to Meet Military
Requirements, November 13, 1995. It is worth
noting that slides associated with these minutes state that there is “insufficient
data to show efficacy against inhalation anthrax.”
Id.
Less than one year from the date of the briefing, on September 20, 1996,
the vaccine manufacturer, MBPI, filed an “initial” Investigational New Drug
Application for AVA. The purpose of the
application was to “conduct clinical investigations designed to investigate changes in the approved
labeling for the licensed product. The
potential labeling changes would effect a specific clinical indication, route and
vaccination schedule for AVA.” See
Cover Letter, MBPI IND Application, September 20, 1996 (emphasis added). The cover form shows three specific bases for the
application, including “inhalation anthrax” exposure.
Of particular note is the Introductory Statement filed with the IND
application. In ¶ 3.1 of the Statement, MBPI
states
the ultimate purpose of this IND is to obtain a specific indication for inhalation anthrax
and a reduced vaccination schedule (emphasis added).
MBPI IND Application.
This IND application by MBPI, which has remained open, unmodified and
current, clearly shows that the Army and the manufacturer, MBPI (now Bioport) moved to
place the AVA in IND status in order to get a labeling change showing the AVA was
effective against aerosol anthrax exposure. The
filing of the IND application by MBPI places the AVA in IND status, allowing for
FDA-approved clinical testing, as well as interstate transport of the vaccine for testing
purposes. As of today, under the FDA
regulations the vaccine is an IND for the purposes for which the application was filed,
namely, for a change in the labeled use to encompass inhalation anthrax.
The DoD’s assertion that, at a later date, the FDA has somehow
“approved” the vaccine for inhalation anthrax is factually and legally baseless
as will be demonstrated in Section C, infra. However,
nothing that various FDA officials say alters the simple fact that the manufacturer, by
its application to FDA, squarely placed the AVA in IND status as a preventative against
inhalation exposure to anthrax and for a reduced vaccination schedule. This is the key point to understanding why
orders to take the shots are illegal: The
vaccine is in an IND status for inhalation prophylaxis (and for an altered
vaccination schedule), and has been since the manufacturer, at the Army’s request,
filed its IND application in September 1996.
The Committee should note that DoD does not have the responsibility or
the authority to place the AVA in IND status or to take it out of IND status. DoD is not the manufacturer of the vaccine; only
the manufacturer can file the IND application. And,
in fact, the manufacturer has done just that and is presumably complying with IND rules.
B.
The AVA is an IND because the DoD, as a matter of policy, is not following
the licensed vaccine schedule.
In addition to seeking a specific FDA license approval for use against
inhalation anthrax, the IND application seeks to modify the licensed vaccination
immunization schedule of three subcutaneous injections given two weeks apart, followed by
three additional subcutaneous injections given at six, twelve and eighteen months. See MBPI IND Application and AVA package
insert (October 1987). Under federal law and
FDA regulations, altering the vaccination schedule for the current AVA would be improper,
because the deviation from the licensed and approved schedule makes the vaccine a “new”
and investigational drug, and also brings it under the aegis of the IND application.
FDA officials, in fact, have advised DoD that
[I]f the military is interested in using a vaccination time schedule
different from the currently licensed schedule for a mass vaccination effort, then
informed consent would be appropriate.
February 18, 1997 Memorandum from Dr. Karen L. Goldenthal, an FDA
physician responding to a telephone call from Admiral Martin re: Anthrax Vaccine.
Although DoD maintained in court filings as late as last summer that it
“specifically follows the FDA approved immunization schedule for the vaccine,”
it is now a matter of policy that members of the Armed Forces will not be vaccinated on
the approved schedule contained in AVA labeling. DoD’s
public announcements, following the failure of the AVA manufacturer, Bioport, to
manufacture vaccine that would pass FDA testing, are clear. The current DoD policy is that
soldiers who have received some, but not all, of the shots will not have to repeat the
initial sequence of shots, even though they may not receive additional shots for up to two
years. The product label for the AVA
specifies an immunization schedule of three injections given two weeks a part followed by
additional three injections at six, twelve and eighteen months. DoD’s straightforward disregard of the
labeling requirements provides further indication of the IND nature of the AVA as it is
being used by DoD today. On this basis alone,
a court could properly find the FDA to be an IND and subject to the requirements of 10
U.S.C. § 1107 and EO 13139.
C.
The FDA letters relied on by DoD to support its position that the AVA is not
an IND have no legal effect and are entitled to no deference by the Court.
In an apparent effort to reinforce the untenable position that the AVA
is properly licensed, various DoD officials asked FDA representatives to opine on whether
the AVA was appropriately used as a prophylaxis against inhalation anthrax.
Unfortunately, none of these letters has any legal viability under the
FDA’s own regulatory system. Cognizant
of the fact that outside entities might place undue reliance on the private informal
opinions of FDA staff, the FDA drafted strict requirements for what it refers to as “advisory
opinions” that might bind or commit the agency.
21 C.F.R. § 10.85(k) specifically states:
a statement made or advice provided by an FDA employee constitutes an
advisory opinion only if it is issued in writing under this Section. A statement or advice given by an FDA employee
orally, or given in writing but not under this Section or § 10.90 is an informal
communication that represents the best judgment of that employee at that time but does not
constitute an advisory opinion, does not necessarily represent the formal position of the
FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
None of the letters relied on by DoD as “proof” that the AVA
is not an IND were issued under either of the 21 C.F.R. Sections listed in the
regulations. Accordingly, under FDA regulations these letters are merely “informal
communications” that have absolutely no legal effect.
As such, these letters cannot modify the clearly defined legal status of the AVA
that results from the filing of the IND application by MBPI, or by variations in the
vaccination schedule currently authorized by various DoD agencies.
Further proof of the letters’ limited scope is contained in the
recent Supreme Court decision in Christensen, et al. v. Harris County, et al., ___
U.S. ___, 120 S.Ct. 1655, 2000 U.S. LEXIS 3003 (May 1, 2000). The Supreme Court specifically found that agency
opinion letters are not entitled to deference by the Court but only to “respect,”
and then only to the extent that the letters’ interpretations are persuasive. Christensen, 2000 U.S. LEXIS 3003 at
*19-20. Given that the letters offered by DoD
as validation of its position regarding the IND status of the AVA are not agency approved
letters, do not incorporate agency approved positions, and fly directly in the face of
clear language in an IND application, this Committee should find that these letters are
unpersuasive and without legal effect.
Indeed, there could be no other result, given the fact that the letters
are totally at odds with the IND application language.
It makes absolutely no sense to believe that FDA officials writing in their
personal capacity can single-handedly invalidate the regulatory scheme adopted by the FDA
to prevent the licensing and interstate movement of Investigational New Drugs.
It is clear from the
IND application, the use schedule, and the legally invalid FDA letters that DoD’s
position is untenable. The AVA is an IND. Under federal law and Executive Order it may not
be given to members of the Armed Forces without their informed consent.
D.
A Federal Statute and a Presidential Order Require Informed Consent From
Service Members Prior To The Administration Of The Anthrax Vaccine
A determination that the AVA is an IND renders
inescapable the conclusion that service members as a consequence of federal law and
service regulations must give their informed consent prior to submitting to vaccinations.
1.
The 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”
specifically provides:
(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 notice containing the
information specified in subsection (d).
(b)
Time of Notice. - The notice required
to be provided to a member under subsection (a)(1) shall be provided before the investigational new drug or drug unapproved for its applied use is first
administered to the member.
(c)
Form of Notice. - The notice required
under subsection (a)(1) shall be provided in writing.
(d)
Content of Notice. - The notice
required under subsection (a)(1) shall include the following:
(1)
Clear notice that the drug being
administered is an investigational new drug or a drug unapproved for its applied use.
(2)
The reasons why the investigational new
drug or drug unapproved for its applied use is being administered.
(3)
Information regarding the possible side
effects of the investigational new drug or drug unapproved for its applied use, including
any known 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. - (1) In the case of the administration of an investigational new drug or a
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 be waived only 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 interests of
the member; or
(3)
is not in the interests of national
security.
(emphasis added).
2.
The Order of the President.
On September 30, 1999, the
President issued Executive Order 13139, entitled “Improving Health Protection of
Military Personnel Participating in Particular Military Operations”. EO 13139 provides in pertinent part:
Sec. 2. Administration
of Investigational New Drugs to Members of the Armed Forces.
(a) The Secretary of Defense (Secretary) shall collect
intelligence on potential health threats that might be encountered in an area of
operations. The Secretary shall work together
with the Secretary of Health and Human Services to ensure appropriate countermeasures are
developed. When the Secretary considers an investigational new
drug or a drug unapproved for its intended use (investigational drug) 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.
(b) It is the expectation that the United States Government will
administer products approved for their intended use by the Food and Drug Administration
(FDA). However, in the event that the
Secretary considers a product to represent the most appropriate countermeasure for
diseases endemic to the area of operations or to protect against possible chemical,
biological, or radiological weapons, but the product has not yet been approved by the FDA
for its intended use, the product may, under certain circumstances and strict controls, be
administered to provide potential protection for the health and well-being of deployed
military personnel in order to ensure the success of the military operation. The provisions of 21 CFR Part 312 contain the FDA
requirements for investigational new drugs.
Sec. 3.
Informed Consent Requirements and Waiver Provisions.
(a) Before administering an investigational drug to
members of the Armed Forces, the Department of Defense (DoD) must obtain informed consent
from each individual unless the Secretary can justify to the President a need for a waiver of informed consent in
accordance with 10 U.S.C. 1107(f). Waivers of
informed consent will be granted only when absolutely necessary.
(emphasis added).
In addition, the provisions of 21 C.F.R. §§
50, 312 (October 5, 1999) support both the federal statute and the Executive Order by
specifically noting situations where the informed consent requirements may be waived. Echoing 10 U.S.C. § 1107, the Regulations note
that only the President of the United States may waive the informed consent requirements
mandated by his Executive Order and federal law. Waiver
is allowed only if one of three preconditions is met – if obtaining informed consent
is not feasible; if obtaining informed consent is contrary to the best interests of the
recipient; or if informed consent is contrary to national security interests. The President has yet to issue any such waivers,
or even initiate action to do so regarding the AVA.
II. The Military
Justice System
The Committee has also
requested that I provide an overview of the differences between the military and civilian
judicial processes as they relate to the anthrax vaccination issue. I will attempt to do so, however, the discussion
here obviously will not be exhaustive.
Military offenses that
relate to the issue of the AVIP are defined in Articles 90 and 92, which discuss which
discuss willful disobedience of lawful commands or orders.
Properly promulgated orders and regulations are presumed to be lawful under
military law, although the prosecution must establish unlawfulness if the defense is
successfully able to raise the issue. Depending
on the circumstances, refusal to follow an order may be punished administratively, through
non-judicial punishment under the Uniform Code of Military Justice (“UCMJ”) or
at a court-martial, which may impose a wide variety of sentences up to and including
death.
The defenses to a
change of refusal to follow a lawful command or order are varied, and can range from lack
of authority on the part of the entity giving the order, to overbreadth or
unreasonableness. Other potential defenses
include justification, necessity, duress, inability or ignorance or mistake. In the case of orders to submit to anthrax
vaccination, the most likely defense is that the order conflicts with a statutory right of
the person receiving the order, i.e., the right to provide informed consent to the
vaccination under 10 U.S.C. §1107, or E.O. 13139. See
Manual for Courts – Martial, Part IV, Paragraph 14.c.(2)(a)(iv)(1998).
It is not uncommon for
a service member accused of refusing a lawful order to be offered an additional
opportunity to comply with the order. Once it
has been established that the service member will not comply, a commander may impose
punishment either through administrative means or under the UCMJ. This is completely different from the
civilian legal system, in which all criminal cases are disposed of in a judicial setting. Administrative punishments can range from
reprimands up to and including administrative separation from the Armed Forces, with a service characterization of either an honorable
discharge, a general discharge (under honorable conditions), or a discharge under other
than honorable conditions.
If a commander believes
that administrative sanctions are not sufficient, she may impose punishment under Article
15 of the UCMJ which allows for a relatively quick process in which the commander can
impose relatively minor punishments for relatively minor offenses. Typically under an Article 15 proceeding, the
commander advises the service member that the service member is believed to have committed
an offense under the UCMJ. The service member
then responds either in writing or with an oral presentation, or both, to the commander,
who then makes the decision whether to impose punishment and to what extent. Maximum punishments are limited given the limited
due process nature of the proceeding.
If a commander feels
the offense is substantial, she may decide to press the matter forward to a court-martial. There are three types of court-martial: summary,
special and general. Summary court-martial is
a simplified, expedited procedure conducted before a commissioned officer who may, but
need not be, a lawyer. A service member must
consent to a summary proceeding, and is not normally entitled to a detailed defense
attorney although he may use civilian counsel. Witnesses
are called and the military rules of evidence are in effect, but only enlisted members may
be tried by summary court-martial. The
maximum punishments are quite limited.
A special court-martial
is conducted before either a military judge or a military judge and panel, or jury, of
three service members. Trial counsel and
defense counsel are appointed to the court and the accused has the right to be represented
by a detailed defense counsel or a civilian attorney.
Any service member may be tried by a special court-martial for any non-capital
offense. The maximum punishments include
confinement for six months and forfeiture of two-thirds pay for six months, as well as a
bad conduct discharge.
The general
court-martial proceeding provides a substantial level of procedural due process. Before convening a general court-martial, the
convening authority must order a pretrial investigation and receive a legal opinion as to
disposition of the charges. General
court-martial may be conducted before a military judge or before a military judge and a
panel of at least five members. The only
limits upon a sentence that can be imposed by a general court-martial are those limited
for each offense in the UCMJ and can include the death penalty, a bad conduct discharge,
or a dismissal for officers.
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