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Protecting Soldiers from Friendly Fire: The Consent Requirement for Using Investigational Drugs and Vaccines in Combat

Published online by Cambridge University Press:  24 February 2021

George J. Annas
George J. Annas*
Affiliation:
Health Law Department, Boston University School of Public Health; Boston University School of Medicine; Boston University School of Law; 1967, Harvard College; 1970, Harvard Law School; 1972, Harvard School of Public Health
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Extract

This could be the world's largest friendly fire incident.

In his classic treatise On War, Karl von Clausewitz emphasizes that courage is the “first quality of a warrior.” He defines two types of courage: “courage in the presence of danger to the person; next, moral courage, or courage in the presence of responsibility, whether before the judgment seat of an external authority or before that of the internal authority of conscience.“ Both were involved in the U.S. military's decision to seek a waiver of informed consent requirements for the use of investigational drugs and vaccines on U.S. troops in the Persian Gulf War. The danger of chemical and biological attack was seen as demanding this waiver; while the Nuremberg Code, medical ethics, and respect for the human rights and dignity of American soldiers cautioned against it. The legal maneuvering to revise consent regulations for wartime conditions provides a case study illustrating how the boundary line between therapy and experimentation can become hopelessly blurred, the differences between law and ethics, and the ethical obligations of military physicians.

Type
Articles
Information
American Journal of Law & Medicine , Volume 24 , Issue 2-3 , 1998 , pp. 245 - 260
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1998

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Footnotes

*

This article is adapted from George J. Annas, Changing the Consent Rules for Desert Storm, 326 NEW ENG. J. MED. 770 (1992).

References

1 Paul Sullivan, founder of the National Gulf War Research Center.

2 Karl von Clausewitz, On War, reprinted in WAR, POLITICS, AND POWER: SELECTIONS FROM ON WAR, AND I BELIEVE AND PROFESS 63, 116 (Edward M. Collins trans. & ed., 1962).

3 See 2 U.S. GOV't PRINTING OFFICE, TRIALS OF WAR CRIMINALS BEFORE THE NUERNBERG MILITARY TRIBUNALS UNDER CONTROL COUNCIL LAW NO. 10, at 189-98 (1946-1949) [hereinafter TRIALS OF WAR CRIMINALS] (finding Karl Brandt guilty of “responsibility for, and participation in, Freezing, Malaria, Lost Gas, Sulfanilamide, Bone, Muscle and Nerve Regeneration and Bone Transiplantation, Sea-Water, Epidemic Jaundice, Sterilization, and Typhus Experiments“); George J. Annas, Mengele 's Birthmark: The Nuremberg Code in United States Courts, 7 J. CONTEMP. HEALTH L. & POL'Y 17, 20 (1992). The full text of the Nuremberg Code:

  1. 1.

    1. The voluntary consent of the human subject is absolutely essential.

    This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

    The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

  2. 2.

    2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

  3. 3.

    3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

  4. 4.

    4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

  5. 5.

    5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve a subjects.

  6. 6.

    6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

  7. 7.

    7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

  8. 8.

    8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

  9. 9.

    9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

  10. 10.

    10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probably [sic] cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

TRIALS OF WAR CRIMINALS, supra, at 181-82. See generally THE NAZI DOCTORS AND THE NUREMBERG CODE: HUMAN RIGHTS IN HUMAN EXPERIMENTATION (George J. Annas & Michael A. Grodin eds., 1992); Evelyne Shuster, Fifty Years Later: The Significance of the Nuremberg Code, 337 NEW ENG. J. MED. 1436 (1997).

4 21 U.S.C.A. § 355(i)(4) (West Supp. 1998).

5 Informed Consent for Human Drugs and Biologies; Determination that Informed Consent Is Not Feasible, 55 Fed. Reg. 52,814, 52,814 (1990) (codified at 21 C.F.R. pt. 50).

6 Exceptions from General Requirements, 21 C.F.R. § 50.23(d) (1997).

7 See Doe v. Sullivan, 756 F. Supp. 12, 13 (D.D.C. 1991).

8 See Doe v. Sullivan, 938 F.2d 1370, 1372 (D.C. Cir. 1991).

9 See id. at 1374.

10 See Sullivan, 756 F. Supp. at 14.

11 Id. at 15.

12 See id.

13 See id. at 18.

14 10 U.S.C.A. § 980 (West 1998).

15 See Schuchardt, Elliott J., Walking a Thin Line: Distinguishing Between Research and Medical Practice During Operation Desert Storm, 26 COLUM. J.L. & SOC. PROB. 77, 96-98, 99-100 (1992)Google Scholar.

16 See Sullivan, 756 F. Supp. at 15-16.

17 See 21 C.F.R. § 50.23 (1997) (listing exceptions to the informed consent requirement); Sullivan, 756 F. Supp. at 16.

18 Sullivan, 756 F. Supp. at 16.

19 See id. at 17.

20 See id. at 17-18.

21 See Doe v. Sullivan, 938 F.2d 1370, 1370 (D.C. Cir. 1991).

22 See id. at 1375.

23 Annas, supra note † at 771; see STAFF OF SENATE COMM. ON VETERANS’ AFFAIRS, 103D CONG., REPORT ON IS MILITARY RESEARCH HAZARDOUS TO VETERANS’ HEALTH? LESSONS SPANNING HALF A CENTURY 21 (1994) [hereinafter SENATE REPORT].

24 See Sullivan, 938 F.2d at 1375.

25 See id.

26 See id. at 1376.

27 See id. at 1377.

28 See id. at 1380.

29 See id. at 1381.

30 See id. at 1381, 1383.

31 See id. at 1383.

32 See id. at 1384-85 (Thomas, J., dissenting).

33 Id. at 1385.

34 Id. at 1386.

35 Id.

36 See DAVID P. CURRIE, THE CONSTITUTION IN THE SUPREME COURT: THE SECOND CENTURY 1888-1986, at 285-93 (1990).

37 See Jill R. Keeler et al., Pyridostigmine Used as a Nerve Agent Pretreatment Under Wartime Conditions, 266 JAMA 693, 694 (1991). All organophosphorus (OP) nerve agents, which include tabun (GA), sarin (GB), soman (GD), and VX and its analogs:

operate on the same principle: they knock out the enzymes (ie acetylcholinesterase) that control the body's balance of acetylcholine—a critical neurotransmitter that determines proper electrical activity in the body. Overstimulated by a surplus of acetylcholine, pupils become constricted, one loses muscular control and normal breathing becomes impossible. The first defence, of course, is proper NBC [nuclear, biological, and chemical] clothing and masks …. The next step is to prepare soldiers for a possible chemical environment by the pre-emptory administration of pyridostigmine (bromide ionic form in the USA). The latter compound protects the body's aforementioned enzyme acetylcholinesterase by, ironically, inhibiting it to a level of about 40 per cent. During the 1990-91 Gulf War the US armed forces used 30 mg tablets of pyridostigmine bromide (PB), one tablet that should have been taken every eight hours. The idea is to allow a temporary inhibition of enzyme by PB so that if a nerve agent is encountered, enough enzyme will remain after exposure so that a crisis can be averted, especially with the subsequent use of an auto-injector and anti-convulsive medication (such as diazepam). The USA fielded a Mark 1 auto-injector that contains an oxime (2-PAMChloride) to help reverse enzymes blocked by the nerve agent, and atropine to counteract overstimulation by accumulated acetylcholine. The theory on reversing enzyme inhibition by oximes may be sound, but in fact there is some question as to the effectiveness of oximes in practice ….

… [O]nce a soldier is exposed, soman is the most difficult to reverse and treat among the nerve agents known to be commonly deployed. The field injector used by the USA (PAM-C1, atropine) is severely limited when it comes to soman.

OP Nerve Agents: A Bibliography, 10 JANE's INTELLIGENCE REV., Jan. 1, 1998, at 44, 44; see infra note 45 (describing the signs and symptoms of nerve agents sarin, soman, and VX).

38 See Edward G. Howe & Edward D. Martin, Treating the Troops (Symposium), HASTINGS CENTER REP., March 1991, at 21, 27-28; Pharmacy Ethics: Waivers for Military Use of Investigational Agents, 48 AM. J. HOSP. PHARM. 1525, 1527-28 (1991)Google Scholar; Schuchardt, supra note 15, at 100-05 (stating that “it is reasonable to conclude that the Pentagon did not conduct ‘research* on the soldiers in the Gulf.“).

39 See DEPARTMENTS OF THE ARMY, THE NAVY, AND THE AIR FORCE, FIELD MANUAL: TREATMENT OF CHEMICAL AGENT CASUALTIES AND CONVENTIONAL MILITARY CHEMICAL INJURIES 2-15 to -19 (1990) (text identical in field manuals Army FM 8-285, Navy NAVMED P-5041 and Air Force AFM 160-11). Of course, this argument assumes that “pretreatment” can be equated with treatment—and this is problematic.

40 The text of the consent form reads:

NOTE: It is desirable that individuals who will receive this toxoid read this consent form at least 24 hours before they are inoculated.

CONSENT FORM TITLE: Inoculation with Pantavalent (ABCDE) Botulinum Toxoid

PURPOSE: Pantavalent (ABCDE) Botulinum Toxoid is a biological product which has been distributed by the Centers for Disease Control (CDC) since 1987. It has been granted an Investigational New Drug (IND) status by the Food and Drug Administration (FDA), Department of Health and Human Services. It is not commercially available in the United States. The toxoid itself is free of cost.

INNOCULATION SCHEDULE: You will be given the toxoid in an initial series on three different dates. 0-2-12 weeks. Your arm will be examined by the investigator two days after each inoculation. You will receive an initial booster 12 months after the first injection of the initial series and, if you continue to work in a high risk laboratory, you will be given subsequent boosters at 2-year intervals. Before receiving a second or subsequent booster, you will be asked to have a 15-20 ml tube of blood taken from a vein in your arm. This is done to check your serum for antibody protection levels (immunity) by the CDC before administration of the booster. The booster will not be given for at least another two years if serum antitoxin levels are found to be satisfactory.

BENEFITS AND RISKS FROM PARTICIPATION: This is an investigational product which may protect you from contracting botulism after exposure. Botulism is a very serious intoxication characterized by weakness, extreme dryness of the mouth, and nerve paralysis. Even with modern treatment, about 8% of botulism patients die. Over 90% of individuals who had both the botulinum toxoid initial series and at least one booster will develop protective antitoxin levels. An unprotected individual involved in a serious exposure to botulism may require botulism horse-antitoxin after such an exposure. Your participation may also provide important public health information on the effectiveness of this toxoid.

The use of this toxoid during pregnancy has not been studied and the toxoid should not be given to pregnant women.

The investigator should be notified if you are enrolled in another medical study. If you ever contract a botulism-like intoxication, the investigator should be notified.

During the first 48 hours from 5 to 7% of individuals receiving this toxoid may experience certain minor side effects such as mild or moderate local reaction at the site of the inoculation. Usually this is redness only, but swelling and/or limitation of arm movement may occur. Rarely, in less than 1% of cases, more generalized reactions have been reported. These may consist of one or more of the following: general malaise; fever and/or chills; headache, sore joints, and stiff neck; dizziness, nausea, or vomiting; double vision; prickling sensation on face and body. If you have any reactions that are suspected to have resulted from the toxoid, you should report them to the investigator listed on this consent form.

There is only negligible risk from having blood taken from your arm/vein.

In the event of physical injury resulting from the administration of botulinum toxoid, there is no provision for compensation on or medical treatment from the CDC.

GENERAL CONDITIONS OF CONSENT: I have read the above statement and I understand the benefits and risks involved. I have been given this opportunity to ask any questions at any time I might desire, and I understand that I have the right to withdraw at any time. I understand that I will not be identified by name in any published report. If, during the course of this study, important facts about my personal health should be discovered, I will be notified.

INFORMATION CONTROL: I understand that the CDC, an Agency of the Department of Health and Human Services, is required to solicit information under provisions of Section 505 (K) of the Federal Food, Drug and Cosmetic Act and cannot otherwise release the vaccine. I further understand that the physician(s) will, therefore, furnish CDC with a report of my response to this vaccine, but that I will not be identified by name in any published reports. Information from this report, together with data from all other patient reports received during the same calendar year, will be compiled and a cumulative report filed annually with FDA. Access to patient files kept by the CDC is granted to the FDA. The information requested is considered relevant and necessary to the investigation of the efficacy and safety of the vaccine and individually-identified data requested may be shared with health departments and other public health or cooperating medical authorities. I understand that an accounting of such disclosures will be made available to me upon request.

41 A record of the October 4, 1991 institutional review board meeting, dated October 5, 1991, reads in part:

The Committee is aware that this protocol depends upon an anticipated waiver of informed consent that is being negotiated with FDA and other agencies as a policy decision related to operation Desert Shield. The Committee has no direct knowledge of the stipulations of this policy nor is the Committee aware that it has been implemented. The 12 week period required for full primary vaccination affords some time for implementation of informed consent, at least within the spirit of the Declaration of Helsinki. Full compliance with written documentation of informed consent as described in Army Regulation 70-25 or 21 C.F.R. 50 may not be necessary, however. The ability to use investigational drugs, biological, and devices in human subjects is predicated on a subject's ability to trust that health care professionals are working in his best interest. Human use committees approve protocols because they trust that their judgment of the protocol and the integrity of the investigators will result in execution of a study exactly the way it is described in the protocol. Our regulations require written documentation of informed consent and documentation of the actions taken with subjects in research, but if our trust is not matched by the integrity and intention of the investigator/care giver, no paper documentation can assure compliance. In which case, there is no difference between oral and written informed consent. In the present scenario, the intent to use pentavalent botulinum toxoid is for the benefit of the soldiers at risk to exposure. The health care providers that will administer the vaccine in the field are there solely for the benefit of the soldiers. There is no reason to believe that those soldiers will refuse vaccination when told of the high risk of death due to botulinum toxin exposure, the low risk of mild reaction to vaccine and the benefit of possible protection if vaccinated. If a soldier does refuse vaccination, and he is one who would be at high risk, he may be required by his commander (AR 600-20, para 5-4) to be vaccinated for his own protection and also for the protection of others if his loss would put others at risk. An alternative action a commander would make, would be to replace him with one who is vaccinated and reassign the soldier within the company where he could personally face the consequence of his decision without risking others. No one need be evacuated because of refusal to be vaccinated. The protocol was unanimously approved by the Committee with the recommendation that requirement of full compliance with documented informed consent as defined in AR 70-25 and 21 C.F.R. 50 be waived and in its stead an abbreviated oral informed consent statement be substituted and administered as described above.

See also Keith Epstein & Bill Sloat, Objection to Gulf War Vaccine Was Overridden, CLEVELAND PLAIN DEALER, Dec. 21, 1997, at 16A (reporting that 8000 troops were given the botulinum toxoid vaccine without being told it was unlicensed).

42 This instruction, however, apparently did not always make its way to the war zone. In one survey of 150 Gulf War veterans, for example, of the 17 who reported getting the botulinum toxoid, 15 were told they could not refuse it. See SENATE REPORT, supra note 23, at 21.

43 See Philip Shenon, New Evidence on Nerve Gas in Gulf War Spurs Inquiry, N.Y. TIMES, July 25, 1997, at A13; Philip Shenon, Panel Urges that Pentagon Lose Gulf Inquiry Authority: Cites Loss of Credibility on Chemical Arms, N.Y. TIMES, Sept. 6, 1997, at Al 1.

44 See SENATE REPORT, supra note 23, at 11-13; Robert W. Haley & Thomas L. Kurt, Self-Reported Exposure to Neurotoxic Chemical Combinations in the Gulf War, 211 JAMA 231, 232 (1997); I. Koplovitz et al., Reduction by Pyridostigmine Pretreatment of the Efficacy of Atropine and 2-PAM Treatment of Sarin and VX Poisoning in Rodents, 18 FUNDAMENTAL & APPLIED TOXICOLOGY 102, 103-05 (1992). Neither General Schwarzkopf nor General Powell seems to have understood how PB worked and its likely ineffectiveness against sarin. In questioning before the Senate Veterans Affairs Committee on January 29, 1997, for example, the following exchange occurred between General Schwarzkopf and Senator Jay Rockefeller on this issue of the effectiveness of PB, atropine, and 2-PAM against sarin:

SEN. ROCKEFELLER: … Now if you took all three, PB, atropine, and 2-pam you were brilliantly prepared for the chemical weapon—type of chemical destructive weapon which we knew Iraq did not have. That is, somin [sic].

I don't even know how to deal with that in my mind, that tens and tens of thousands of soldiers were given the atropine/2-pam, I'm not quite sure, PB. Many, many soldiers weren't warned, weren't you know, under the Nurenburg [sic] trials investigational drugs, all the rest of it, but they didn't know about it. But even if they had, if it had all been done correctly, it would have been completely ineffective against what it was we know the Iraqis would put on us if they were going to do it.

I cannot fathom how DOD could allow something like that to happen. Do you have any thoughts?

GEN. SCHWARZKOPF: I can't—I don't know either. Obviously I didn't know about this.

SEN. ROCKEFELLER: How could they not know about it?

GEN. SCHWARZKOPF: It's a shock right now. We knew that they had—as far as I was concerned, atropine[,] … [which] is a treatment against nerve gas poisoning …. And I've had to inject myself, inject an orange. We had the troops inject oranges and all this other thing to learn how to administer the stuff. So that's where the atropine came from. As far as I was concerned, the other medications that were being sent over there that we'd been told about I thought were completely effective against a nerve agent. I know nothing's going to be effective against a mustard agent because of its burning capabilities, but I thought it was a nerve agent, or perhaps a blood agent.

I think that you're probably seeing, and I—it's fair to say this that we were preoccupied with the Iraqi chemical weapons. I mean, we were scared to death of the Iraqi chemical weapons because they're mass casualty producers and they're indiscriminate in who they kill. I mean, they don't just kill a soldier. They kill anybody who they come in contact with.

And what you are probably seeing, or what you are probably recounting, is a reaction, perhaps an over-reaction to coming up with any kind of antidote that they could come up with to prevent our troops from being killed by [] chemical weapons.

SEN. ROCKEFELLER: But they wouldn't have done it—they would have been totally ineffective.

GEN. SCHWARZKOPF: You're one up on me, Senator, because I don't know that.

SEN. ROCKEFELLER: That's my concern, that somebody like me could be one up on you, when you were theater commander out there.

GEN. SCHWARZKOPF: It concerns me a little bit, too.

Persian Gulf War Illnesses: Hearings Before the Senate Comm. on Veterans’ Affairs, 105th Cong. (Jan. 29, 1997) (testimony of General Norman H. Schwarzkopf, U.S. Army Retired), available in LEXIS, Legis Library, Fednew File.

General Powell later testified, on April 17, 1997, before the same committee that although he had no personal knowledge of the effectiveness of PB against sarin, he relied on FDA's approval of its use in the Gulf as complete justification:

The one issue that was especially difficult for us and for me personally was the use of PB, as Senator Rockefeller referred to it, and the other vaccines that were available to us, and prophylactics that were available to us, to protect our troops against nerve agents and against some of the biological agents. We knew that these were experimental drugs. We knew that they did not enjoy the level of approval that the FDA normally gives to such drugs for mass consumption.

But members of the committee, I must say to you, that we approved the administering of those drugs to our troops with the full assurance from the FDA that they were safe for human use and that they were effective. The suggestion that somehow I, as chairman of the Joint Chiefs of Staff, would sit in the Pentagon and approve the use of medicines for our troops that I knew at the time to be improper or injurious to our troops or put them at some risk—it's just not accurate, sir. It is not accurate.

The FDA approved those medicines, those vaccines, those toxoids for use with our troops under investigational waiver authority. And that's the way in which we used them.

We knew there was a risk in doing this because it did not enjoy the highest level of general circulation FDA approval. And I still remember a meeting in the tank one day, our command center for the Joint Chiefs of Staff, where, after the chiefs had examined this with their own surgeon generals, we brought all the surgeons general together, with the assistant secretary of defense for health, and asked if we were absolutely sure that this was an effective prophylactic method and whether or not the FDA approved these items as being safe for use by our troops. And the answer was yes.

Holds Hearing on Gulf War Illness: Hearings Before the Senate Comm. on Veterans’ Affairs, 105th Cong. (Apr. 17, 1997) [hereinafter Hearing on Gulf War Illness] (testimony of General Colin Powell, Former Chairman of the Joint Chiefs of Staff), available in LEXIS, Legis Library, Poltrn File.

45 See Hearing on Gulf War Illnesses, supra note 44; Robert W. Haley et al., Letter, 278 JAMA 385, 385-87 (1997) (listing useful sources); Robert M. Sapolsky, The Stresses of Gulf War Syndrome, 393 NATURE 308 (1998). The Medical NBC Officer Field Manual describes sarin, soman, and VX as follows:

Nerve agents are primarily organophosphorus esters similar to insecticides. Those of military importance are combined under this term. Although some have been given names, they are usually known by their code letters: GA (TABUN); GB (SARIN); GD (SOMAN); and VX.

Sarin (GB) Colorless liquid giving off colorless vapor with a faint fruity odor.

Soman (GD) Colorless liquid giving off a colorless vapor with odor of fruit (camphor when impure). Permanently binds to receptors in two minutes. After that 2 Pam Chorilide is not useful.

VX—In some countries the “V” agents are known as “A” agents. Colorless to amber oily liquid with faint odor of rotten flesh.

The Characteristic Signs and Symptoms of Nerve Agent Poisoning are:

46 See The Iowa Persian Gulf Research Project: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Government Reform and Oversight, 105th Cong. (Jan. 21, 1997) (statement of David A. Schwartz, M.D., M.P.H.), available in LEXIS, Legis Library, Fednew File [hereinafter Iowa Persian Gulf Hearings]; Haley et al., supra note 45, at 385-86; see also Iowa Persian Gulf Hearings, supra (statement of Robert W. Haley, M.D.) (describing symptoms of Gulf War syndrome and possible sources of exposure). It has been persuasively suggested that the institutional inability of the Department of Defense to investigate the possible link of PB and low level nerve gas exposure to Gulf War syndrome is based on a desire to continue to present the Gulf War as a “clean” war with few casualties:

If there is such a thing as institutional stubbornness, the Pentagon has it. All bureaucracies react to something that could cost them face much the way a sea anemone touched by a finger does—they close up and seal off. But DOD is particularly prone to such reactions, which makes the science worth studying in the story of Gulf War syndrome behavioral as much as biological.

More than most bureaucracies, the military faces very public tests of its effectiveness. Since it failed one of those tests in Vietnam, exposing itself to years of abuse, humiliation, and low public esteem, the Pentagon has been especially defensive, and eager for redemption—which the Persian Gulf War provided. It dispatched the military's Vietnam complex, sending institutional pride to new heights. It was the mythical “perfect war.” Then along comes not only a nasty set of illnesses, but a plethora of investigators muddying the myth by churning up questionable decisions, vulnerabilities, and just plain mistakes on the military's part.

The apparent stonewalling seems to have been an attempt to paper over bungling or negligence that would tarnish the Gulf victory, as well as the careers and reputations of those associated with it. This same phenomenon surfaced in the investigation of the terrorist bombing at Khobar Towers in Saudi Arabia…. The inclination was to prioritize protecting the institution over protecting the troops.

Amy Waldman, Credibility Gulf: The Military's Battle over Whether to Protect its Image or its Troops, WASH. MONTHLY, Dec. 1996, at 28, 28-29; see also Philip Shenon, Another Televised Strike Against the Pentagon, N.Y. TIMES, May 31, 1998, at 34 (reviewing Showtime's “Thanks of a Grateful Nation,” which portrays the struggle of Gulf War veterans to learn the causes of Gulf War Syndrome).

47 See Johnson, W.H., Civil Rights of Military Personnel Regarding Medical Care and Experimental Procedures, 117 SCIENCE 212, 213 (1953)Google Scholar.

48 United States v. Stanley, 483 U.S. 669 (1987).

49 For current DOD biological warfare research proposals, see JOINT PROGRAM OFFICE FOR BIOLOGICAL DEFENSE, U.S. DEP't OF ARMY, JOINT VACCINE ACQUISITION PROGRAM: FINAL PROGRAMMATIC ENVIRONMENTAL ASSESSMENT (June 1997).

50 See supra note 37; see also SENATE REPORT, supra note 23.

51 The Harassment of Female Troops, N.Y. TIMES, Sept. 13, 1997, at 22.

52 Accessibility to New Drugs for Use in Military and Civilian Exigencies When Traditional Human Efficacy Studies Are Not Feasible; Determination Under the Interim Rule that Informed Consent is Not Feasible for Military Exigencies; Request for Comments, 62 Fed. Reg. 40,996, 40,996 (1997). The three major reasons DOD presents to retain the current waiver rule all confuse and conflate research with treatment:

  1. 1.

    1. When the President commits U.S. military forces to a combat, peacekeeping, or humanitarian deployment, the U.S. Government has a duty to take all reasonable precautions to bring about a successful completion of the mission and a safe return of the deployed forces.

  2. 2.

    2. The Government's duty to take all reasonable precautions to preserve the fighting force must include recognition of the startling proliferation of chemical and biological weapons among potential adversaries and terrorist organizations and an obligation to commandimplement the best possible medical countermeasures.

  3. 3.

    3. Implementation of the best possible medical countermeasures may require the standardized treatment use of an investigational new drug or vaccine for all personnel at risk in a military combat exigency, including those personnel who, for whatever reason or no reason at all, would prefer an alternate treatment or no treatment.

Id. at 41,000.

It should also be noted that even though DOD continues to support the rule, it apparently does not follow it. In Bosnia, for example “nearly 4,000 soldiers were told during military briefings that the vaccine, called TBE, was ‘already known to be very safe and extremely effective'” although it was a research vaccine designed to protect against tick-borne encephalitis and not approved by FDA. Bill Sloat & Keith Epstein, Army Misled Troops Who Got Vaccine in Bosnia, CLEVELAND PLAIN DEALER, Jan. 25, 1998, at 1A.

53 On October 24, 1997, Leonard Glantz, Michael Grodin, and I wrote the following response to FDA's request:

We strongly urge the FDA to revoke the interim final rule that is described in the request for comments as permitting “the Commissioner … to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat.” The central issue the proposed rule raises is “Can military personnel, all of whom are competent adults, be used as subjects of medical research without obtaining their informed consent?” Because the answer to this question is so clearly “No” we will only respond to the first question: “Should the FDA revoke the interim rule? If so, why?”

The answer is that the FDA must revoke the interim rule because it violates every code and ethical principle developed since World War II to regulate research with human subjects. The Nuremberg Code that states, “The informed consent of the human subject is absolutely essential.” While there are exceptions to this blanket statement for young children and other incompetent subjects, we know of no exception to this rule for competent adults until the FDA issued this interim rule.

The interim rule amended 21 C.F.R. 50.23. Prior to this amendment, this section dealt entirely with a class of subjects who were “confronted by a life-threatening situation necessitating the use of a test article,” and “informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.” 21 C.F.R. 50.23 (1) and (2). This entirely reasonable rule permitted the use of an investigational substances [sic] in currently life-threatening situations for people who were not able to speak for themselves, but for whom we could reasonably surmise would want the use of a substance that could well save their lives. But it would be scandalous if this rule permitted the use of lifesaving investigational substances on competent adults without their consent. It is the subject's very incompetence that makes this rule ethically acceptable.

It is simply wrong to place a rule that enables soldiers to be used as human subjects without their consent in the section of the regulations that deals with exceptions to the informed consent requirement based on lack of feasibility of obtaining consent. Every soldier on active duty is capable of giving consent. It might be burdensome or difficult for the military to obtain consent from these soldiers, but it is certainly “feasible.” Since every soldier must be given the investigational substance, every soldier could, at that point in time, be given information that would enable him or her to determine whether to become a research subject. Military personnel would, of course, also have to be told that they were not required to participate in such research. The military's position is essentially as follows:

  1. 1.

    1. It is not acceptable to defer to a soldier's personal preference concerning a preventive or therapeutic treatment that “might” save his life, or avoid endangering other military personnel.

  2. 2.

    2. It is not defensible militarily or ethically, to send a soldier unprotected into danger.

  3. 3.

    3. Special military exigencies sometimes must supersede normal rights and procedures that apply to civilians and, thus, military regulations state that military members may be required to submit to medical care.

All of this might be true. But it is unrelated to the question of whether it is acceptable for the military to require soldiers to become human subjects. If the military has a substance that it believes will keep soldiers healthy in battle, it should use it. Soldiers in battle are subject to all types of risks not incurred by civilians. The risks that solji diers are exposed to is a command decision, subject to review through military and international codes. What is clearly unacceptable is to turn soldiers into human subjects.

A whole body of international rules has been developed along with federal and state rules that are designed to protect human subjects. The cornerstone of all these rules is the necessity of the consent of competent subjects. Indeed, protecting human subjects and treating them with respect has been the consistent policy of the Department of Defense since 1953 when the Secretaries of the Army, Navy and Air Force adopted a memorandum entitled “Use of Human Volunteers in Experimental Research.” That memorandum authorized the use of Armed Services personnel for human volunteers subject to certain conditions. The first condition was “The voluntary consent of the human subject is absolutely essential.” This adoption of the Nuremberg Code's ethical requirement as a precondition to the use of military personnel as human subjects has been the policy of the military until it asked the FDA to excuse it from this vital ethical norm.

The exception to the requirement of informed consent for competent adults who are in the military is the only exception we know of based on employment or status. The Office of Protection from Research Risks has particular rules for research performed on fetuses, prisoners and children. But each one of these rules is designed to give those classes of subjects more protection than they might receive under the general rules. The interim rule is the only one that provides a class of people with less protection be- cause of the class to which they belong.

Because the interim rule deviates so substantially from national and international rules and norms that protect human subjects and require their respectful treatment, and because they are so inconsistent with the rest of FDA policy protecting human subjects, we urge you to revoke the in-terim rule.