MAGICAL MEDICINE: HOW TO MAKE AN ILLNESS ... - Invest in ME

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“An important condition of a justified psychiatric intervention is the informed consent of a patient…The formal
acquiescence of a patient is not a sufficient criterion of informed consent”.
Schramme continues: “Even if someone is not physically forced to choose to act in a certain way, he may nevertheless
not actually wish to act in this way….Because of an offer, he does something he does not identify with (and) many
offers – at least in some contexts in psychiatry—can be regarded as morally dubious” (as, perhaps, an ME/CFS
patient having to choose between the loss of necessary access to a clinician at a “CFS” Clinic unless s/he
agreed to take part in the MRC Trial of CBT/GET).
Schramme says: “offers that are directed against the will we may refer to as cases of manipulation…..I would like to
suggest that an offer is irresistible when it exploits dependency”. He then gives the example of refused
benefits becoming a threat or, at the very least, coercion, leaving a patient without a real choice. (Coercive
Threats and Offers in Psychiatry. In: Thomas Schramme and Johannes Thome (eds). Philosophy and
Psychiatry. De Gruyter 2004:357‐369).
Orlowski and Christiensen use the term “coercion” to include subconscious or subliminal pressure to choose
to act:
“Anything that unfairly entices or forces a research subject to participate in a clinical research trial is prohibited by
various national and international research codes of ethics, including the Belmont Report and The Nuremberg Code.
The Nuremberg code states as its first principle that: ‘The voluntary consent of the human subject is absolutely
essential. This means that the person involved 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, overreaching, or other
ulterior form of constraint or coercion’ “.
Orlowski and Christiensen regard coercion as “anything that would impede the exercise of the free power of
choice, especially overt or covert enticement” (again, the issue of an ME/CFS patient having to choose either
the loss of access to a clinician at a “CFS” Clinic or agreeing to take part in CBT/GET springs to mind).
Orlowski and Christiensen quote the Belmont Report on Ethical Principles: “This element of informed
consent requires conditions free of coercion and undue influence”.
They draw attention to the Council for International Organisations of Medical Sciences’ International Ethical
Guidelines which, in the section titled “Obligations of Investigators Regarding Informed Consent”, state that the
Investigator has a duty to “…exclude the possibility of unjustified deception” (Chest 2002:121:2023‐2028).
Concerns about coercion in the PACE Trial continue to mount, because coercion is one of the ways that
consent can misfire and research trial Investigators are obliged to ensure that subjects’ participation is not
secured by coercion or misrepresentation (see below for examples of apparent misrepresentation that seem
to have occurred in the PACE Trial).
In “Undue Influence as Coercive Offers in Clinical Trials”, Joan McGregor, Lincoln Professor of Bioethics,
Arizona State University; Professor of Basic Medical Sciences and Director of Biomedical Ethics and Medical
Humanities, speaks with authority:
“Coerced or deceived consent does not respect the subject’s freedom to decide on his or her own what risks to
assume….Informed consent is undermined when there is coercion or ‘undue influence’…..Vulnerable
populations can include…those vulnerable because of their circumstances….Their consent to participate may be less
than fully voluntary because…of their lack of alternatives…The Common Rule specifies that the researcher must guard
against coercion and undue influence (I would include deception as well) since they can affect the voluntariness of the
agent, thereby vitiating informed consent…Coercion is a central issue in moral, political and legal philosophy because
it undermines the freedom of the victim by making his or her consent invalid…Coercers ensure that their victims
‘choose’ the option that the coercers want (in that) the victim must ‘choose’ the lesser of two evils…Clinical