NATIONAL DEFENSE AUTHORIZATION ACT (NDAA) & INFORMED CONSENT The Missing Piece: The Spirit of the Law

by

Anthony N. Lalli

December 5, 2017

copyrights 2017 (c) Anthony N. Lalli All Rights Reserved

The Intermingling of Ethics and Law: The Spirit of the Law

The National Defense Industrial Association (NDIA), in their Ethics clause say, “…key principles that include honesty, fairness, equality, dignity, diversity, individual rights and the rule of law” (1), and it should be applauded. However, in the case of the NDAA (2,26), it would void the NDIA’s so said virtues (1), at least, in the case of the health and safety protections of our U.S. Military personnel. Moreover, the NDAA (2,26), could turn our U. S. Military personnel and some Veterans, into experimental animals, and it has been done before (5,9). Moreover, fairness, equality, individual rights (human rights), some of elements of Natural Law, invoked in the Declaration of Independence (8), and that which allows us the rights to “Life, Liberty and the pursuit of Happiness”, would apply only to U.S. Senators, Members of the U.S. House of Representative, most U.S. civilians, and in some instances, dogs and cats, but not to our U. S. Military, and perhaps, in some cases, Veterans. 

It is correct to say that avoidance of Human Research Subject Protect (HRSP) for our U. S. Military personnel is long overdue (3), but the NDAA (2,26), as written, would not be a legally binding law, and therefore, cannot legally be followed by U. S. Military persons, in as much as U. S. Military personnel cannot follow an illegal order (5,6,9); therefore, the NDAA (2,26), if it were to become law, could not be enforced, regarding.

 

An Illegal Order & The Uniform Code of Military Justice (UCMJ)

Moreover, the US Constitution’s Article 1, Section 8, so states “To provide for organizing, arming, and disciplining, the militia, and…the authority of training the militia according to the discipline prescribed by Congress;” (4,5), which is a very broad and a scant description of what the Congress can and cannot do, especially, regarding the health and welfare of U.S. Military personnel. In fact, Article1, Section 8 (4), is so broad, and the times have changed so much since it was written, the real authority lies in judgements based on today’s ethics and laws (11).

For instance, how are ethics and law intermingled? In a broadly written law the writers of that law, in this case our forefathers, depend on the people, that is us, more specifically, the Congress, to interpret Article 1, Section 8 (4), in terms of the Spirit of the Law (the intent of the Law), and today’s current guide is the 13^th Amendment, Contract Law (5,9,30,31), plus a number of other relevant laws (22), and all of which is in tangled in our sense of right and wrong, as so etched in the hearts of men, and in the UCMJ (6). Essentially, right or wrong is more narrowly written in the UCMJ (6) and, says, Military personnel are only required to follow legal orders, therefore any Military person obeying the NDAA (2,26), as written, would be following an illegal order, which is something they cannot do (6). What’s more, the NDAA’s current draft (26), since it seems to be an illegal law (5,9), the only way it could be enforced is to amend the Contract (5,30,31,22) of every Military person, and thusly they would be forced to sign it, or be Court-Martialed (6), but that would be a questionable tactic (22); then there are number of other laws to consider (5). Consequently, the NDAA (2,26), as written, seems to usurp both Constitutional Law (4,5,22), as well as Codified Law (5,22).

The Spirt of the Law, invokes God, Country, and Duty, which is not just the responsibility of our U.S. Military, but also “We the People” (7); said differently, it contains our values, it is Legal Ethics, it is what should make us different from any other existing nation, and it is our connection to “In God we Trust”. The Spirit of the Law invokes and provokes our very Soul, our piece of God Himself, the missing piece sometimes in man’s humanity.

Furthermore, The Declaration of Independence reads, “Prudence, indeed, will dictate that Governments long established should not be changed for light and transient Causes; … But when a long Train of Abuses and Usurpations, pursuing invariably the same Object, evinces a design to reduce them under absolute Despotism, it is their Right, it is their Duty, to throw off such Government, and to provide new Guards for their future Security” (8). There has been a long train of Military and civilian abuses (5,9,12,13,28), and “discipline” (4) should not be a euphemism for exploitation, that is, an excuse for despot ideology, just because Congress can (2,26), rather than to do better than we have done in the past, especially for our U.S. Military personnel and Veterans. Call to mind the words of George Santayana, “Those who cannot remember the past are condemned to repeat it” (10). The Military are some of the most at-risk people that are defending the U.S. Constitution, and they are relying on us, “We the People” (7), that is Congress, to protect them, as well as their unborn children. The U.S. Military personnel are depending on us, even though they won’t say it, and because, even though they may not know it, unapproved FDA drugs and perhaps even medical devices, can have a surprisingly (22) adverse effect on their offspring, the most innocent of all. Most U.S. Military persons, especially the young, will roll up their sleeves most willing, for say an injection, where they know nothing about its safety, because they were given an order, and that naïve willingness is what “We the People” (7) must guard against. How did we ever get to this point, where virtue and decency has fallen apart, even though, in the Declaration of Independence, it refers to the ideals of Natural Law (8)?

Natural Law

Constitutional Theory is a complex subject belonging mainly in the domain of Constitutional Law scholars, but it is important to touch on it here, at least in the most basic sense, regarding The Spirit of the Law, as it relates to what is right and wrong, and on Congress’ decisions concerning the NDAA (2,26).

There are generally three schools of natural law theory: (15)

• “Divine natural law represents the system of principles believed to have been revealed or inspired by God or some other supreme and supernatural being. These divine principles are typically reflected by authoritative religious writings such as Scripture”.
• “Secular natural law represents the system of principles derived from the physical, biological, and behavioral laws of nature as perceived by the human intellect and elaborated through reason”.
• “Historical natural law represents the system of principles that has evolved over time through the slow accretion of custom, tradition, and experience. Each school of natural law influenced the Founding Fathers during the nascent years of U.S. law in the eighteenth century and continue to influence the decision-making process of state and federal courts today”.

We as a people, are probably influenced by all three of these concepts, known as Natural Law, and so stated in the Declaration of Independence (8). So, it is our conscience, that is the determining factor of what is right and wrong, which is the embodiment of The Spirit of the Law. No law is perfectly written, if that were true there would be no need for Judges and Juries, so there is always man’s conscience tugging on our values of what is human and what is the right thing to do.

But in a democracy, where we are a principled people, a single perspective is an absurdity. So, while our founding fathers alluded to Natural Law (8), they had to know that it was not an absolute, but only a guide. For instance,” …natural law continues to thrive, although the particular system which one community constructs may be abandoned by succeeding generations.  Periods of growth in the law have been frequently accompanied by shifting in natural law premises. An old system of natural law soon becomes sterile when there is immediate necessity for an extension of legal principles” (11).

So, is our eagerness to win wars, so intense, that our present-day value system has become sterile? This may come down to an issue where “from Aristotle and Thomas Aquinas to Abraham Lincoln and Martin Luther King” (14) versus Thomas Hobbes; could this really be Liberals & Moderates vs. Conservatives? For instance, the Hobbian view of the Libya war interprets as: “For this reason, political realists argue that there are and can be no rules for the conduct of foreign policy other than the Hobbist “laws of nature,” which are essentially prescriptive guidelines for maximizing self-interest and power at the direct expense of everyone else” (17). In the NDAA (2,26), the notion, “at the direct expense of everyone else” seems to include the Health and Welfare of our Military personnel, especially during a war.

Let us delve further into Hobbian Natural Law:

[1.] “Today, natural law is not discussed very much, at least not explicitly. When mentioned at all, it is usually rejected as dangerous because it undermines existing laws…” (18).

But consider this, the NDAA (2,26) as written undermines both the 13th Amendment and Contract Law (5,9,30,31), as well as number of other laws (22).

[2.] “This negative view of natural law can be traced to Thomas Hobbes (1588–1679), whose writings are largely devoted to showing the anarchy and civil wars caused by appeals to natural and divine laws above the will of the sovereign” (18).

But consider this, in our Democracy, separation of Church and State, would seem to remedy Hobbes’ negativity.

[3.] “Hobbes rejects the teleological view of human nature as a false and dangerous illusion. Instead, he sees human nature as the restless striving for power after power that has no end and therefore no happiness or perfection” (18).

But consider this, Thomas Jefferson would seem to remedy that notion with Life, Liberty, and the Pursuit of Happiness (29).

[4.] “… if higher laws are not equated with intangible goods like virtue, wisdom, and salvation, then the ills of civilization can be avoided, and mankind can enjoy enduring civil peace” (18).

But consider this, this kind of thinking has echoes of John Lennon’s song Imagine.

[5.] “Herein lies the crucial move in Hobbes’s shift from classical natural law to modern natural rights: the idea of the greatest good is a dangerous illusion because it is vain, unreal, and never produces agreement; but the minimal good of avoiding death is the strongest, most real, and most universal passion: “for every man is desirous of what is good for him, and shuns what is evil, but chiefly the chiefess of natural evils, which is death”” (18).

But consider this, perhaps this Hobbes notion could be applied to nuclear deterrence.

One last contemporary thought, in the Movie, Cinderella Man, there was an interesting Hobbian soliloquy between the fight promoter and the fighter, James Braddock’s manager. Braddock’s manager sarcastically said to the promoter during their disclaimer exchange that he was all heart. The promoter fired back, and said, my heart is for my family, my balls and my brains are for my business (19). It not only is Hobbian, but it is also a very 21^st century response. Are we losing our scruples? It seems so in the NDAA (26), regarding HRSP.

The Remedy

We can do better and here is how. First, the NDAA (2,26), regarding HRSP, seems to be an illegal law and cannot be followed (5,6,9,22). Two, you don’t have to be in uniform to be a patriot and be deeply concerned about America’s National Security. While the Food and Drug Administration (FDA) is not perfect (20,21), it is one of our better Agencies, and we can use parts of some recent laws, known as the Emergency Use Authorization (EUA) and Expanded Access (EA) lists (22), as a part of the solution.

Science can be frustrating; it seems to take forever to prove that something safely works, especially in a critical care intervention. But it takes years, for let’s say, the advancement, in design of a new airplane (20), especially in a critical instance of war, where new and completely tested technology could save lives. We are never satisfied, we always want better, but sometimes, we just must hurry up, and wait. Sometimes, we are stopped in our tracks, and people succumb to their injuries and diseases; so, it hurts, and even rugged men pain. However, we cannot let it crush our spirit, nor the Spirit of the Law, just because we are disheartened, we must always fight off what seems like a godless Hobbes and reach for interpretations and writings of that higher law, that which is sanctified, in our moral sensibilities.

The Department of Defense (DOD) is a huge sprawling Department (25), that should not be involved with human medical research and experimentation, because it neither has the temperament ((5,9,12,14) nor the specialized knowledge that the FDA possesses. The FDA already has in place the EUA and EA (22), and it could be used in the combat theater of operation, and connected to an individual’s informed consent wishes, that is, in advance of deployment. How could it work?

The DOD would work in cooperation with the FDA, where for example, once a medical product is at an approval Phase that it deems should be added to the EUA and/or EA lists (22), then that product or device can be explained to each applicable Military person, on the risks involved, and get their informed consent. Moreover, accurate records should be kept, therefore, on the battlefield, both Doctors and Medics should carry a mini recorder, that would eventually be transcribed, so researchers can learn from the interventions. A similar proposal is already under way (24), but what could also help, is perhaps a small, numbered tattoo, in a critical part of the body, like the heart (invisible ink, viewed with ultraviolet?). The EUA and/or EA lists (22), would have to number each approved drug or device that it has logged on its List, and the field medic, and or doctor, would know by the number whether to proceed or not. Approval of a drug and device safety is in the dominion of the FDA, and it should not venture out into the realm of the DOD except, in an advisory capacity.

Naturally, this is a rough concept on how the EUA and EA list could be used, for instance, an EAU phase three vaccine may warrant no consent, whereas a chemical antidote that had no human trials would require informed consent; on the other hand, an EA product, like freeze dried serum also would require informed consent.

 

Other Concerns About the NDAA

What is really going on inside the NDAA (2,26) is a good old fashion turf war. The monstrosity DOD (25) wants a piece of the FDA and “for maximizing self-interest and power at the direct expense of everyone else” (17), which is very Hobbian, and in this case “everyone else” could very well be our U.S. Military personnel.

Furthermore, “Birds of Feather Flock Together” (9), is where people with the same values seem to find each other, and associate with each other. So here is why the following is biased and dangerous (26).

Furthermore, “Birds of Feather Flock Together” (9), is where people with the same values seem to find each other, and associate with each other. So here is why the following is biased and dangerous (26).

Furthermore, “Birds of Feather Flock Together” (9), is where people with the same values seem to find each other, and associate with each other. So here is why the following is biased and dangerous (26).

• 1519
• 732. “Additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war”.
• “(5) (A) “There is established in the Department of Defense a Department of Defense Emergency Use Authorization Committee (in this paragraph referred to as the ‘Committee’) to advise the Assistant Secretary of Defense for Health Affairs on proposed authorizations under this subsection”.
• “(B) Members of the Committee shall be appointed by the Secretary of Defense and shall consist of prominent health care professionals who are not employees of the Department of Defense (other than for purposes of serving as a member of the Committee)”.

It is this phrase “appointed by the Secretary of Defense”, which goes to why the DOD, should stay out of the business of the FDA, because of the suspect built in partiality (9).

 

Conclusion

US Military and Veterans have certain attributes that all Americans have, they are human, and they should be afforded the same Human Research Subject Protections that American civilians have, even though the United States informed consent policies are weak, at best (9). Finally, all Americans are threatened by waivers and exceptions to informed consent, written into Common Rule (27,9), so it is time to take a second look at Bill S.193, The Human Research Subject Protection Act (9). Yet ultimately, any directive dealing with medical products should be struck from any part of the NDAA (26); approval of drugs and medical devices should remain for all Americans, under the authority of the FDA, and intervention records are a must.

Update Note: Two citations have been added: 30, 31, on December 13, 2017, to aid in clarifying the Enlistment/Reenlistment U.S. Military Contract.

Update Note: Citation 22, was changed to link to a new Essay which delves deeper into the Legality of Human Research Subject Protect for U.S. Military personnel, on January 10, 2017

Updated: may a slight addition, January 20, 2018, in the Illegal Order topic.

Updated: Expanded on the EA and EAU list and how they could be used in relation to inform consent.

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