May off label and not yet approved medications be used on military per · Medical

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10 May off label and not yet approved medications be used on military personnel if it could save their lives?

Specific Topic(s):

• This question covers the topic of research and innovation in emergency situations.

Key references:

‘Ethical principles of health care in times of armed conflict and other emergencies’ –

1. Ethical principles of health care do not change in times of armed conflict and other emergencies

and are the same as the ethical principles of health care in times of peace.

2. Health-care personnel shall at all times act in accordance with relevant international and national

law, ethical principles of health care and their conscience.

Geneva Conventions:

All of the Geneva Conventions ban medical experimentation on the protected populations – armed forces, prisoners of war and civilians.

First Geneva Convention, Article 12; They shall not be subjected to torture or to biological experiments

Second Geneva Convention, Article 12; They shall not be murdered or exterminated, subjected to torture or to biological experiments.

Third Geneva Convention, Article 13; Not subjected to physical mutilation or to medical or scientific experiments of any kind which are not justified by the medical, dental or hospital treatment of the prisoner concerned and carried out in his interest.

Fourth Geneva Convention, Article 32. Prohibition of medical or scientific experiments not necessitated by the medical treatment of a protected person

Customary IHL:

Rule 92. Mutilation, medical or scientific experiments or any other medical procedure not indicated by the state of health of the person concerned and not consistent with generally accepted medical standards are prohibited. https://ihl-databases.icrc.org/customary-ihl/eng/docs/v1_rul_rule92

Ethical principles:

WMA INTERNATIONAL CODE OF MEDICAL ETHICS - https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/

A PHYSICIAN SHALL act in the patient’s best interest when providing medical care.

Discussion:

Review of the question: this question lies at the heart of the conduct of research and innovation in military medicine where new/novel uses of drugs and medical devices might improve clinical outcomes. However, it is also subject to considerable risk for both the patient and clinician if such activities are undertaken without proper process and oversight.

Interpretation of the principles/policy from the references: There are very explicit prohibitions on medical experimentation during conflict as a result of abhorrent medical research programmes on prisoners in both Nazi Germany and Japan during WWII. However, healthcare professionals are also obligated to act in the patient’s best interest when providing care, which might include undertaking research to establish the best forms of medical care. At the individual level, this might involve off-label/un-licensed use of existing drugs.

Framework for answering the scenario/question:

• What should be the baseline of clinical practice by clinicians within military medical units?

• Might variations in practice by individual clinicians be acceptable?

• In what circumstances might off-label/unlicensed use of drugs be already acceptable in military medical practice? (e.g. in established practice for populations that could not have been included within the regulatory licence such as children)

• How might experimentation with existing drugs be evaluated in military clinical practice/environments?

• Is it legal to undertake properly authorised medical research on every type of patient that might be admitted to a military medical unit on operations?

Further discussion points:

• What drugs/medical interventions have been developed as a result of military medical research? Discuss the drivers for these innovations? [vaccines, blood transfusion, antibiotics, analgesics, tranexamic acid, Factor VII etc.] ... What harms have occurred as a result of military medical research programmes? [nuclear weapons, chemical agents, chemical agent antidotes – type ‘Ronald Maddison Porton Down’ and ‘Unethical human experimentation in the United States’ into Google for examples]

• What oversight bodies exist for military medical research? How might they be different from civilian oversight bodies? [for the UK, consider the role of the MOD Research Ethics Committee and the Advisory Group on Military Medicine]

• What specific issues should be considered when conducting medical research in emergency settings?

• What specific issues should be considered when conducting medical research in humanitarian settings?

Author: Professor Martin Bricknell