Am

J Psychiatry

/36:7, July /979

Informed

Consent

BY JOSEPH

JOSEPH

for

DEVEAUGH-GEISS,

Neuroleptic

Therapy

M.D.

cult to ascertain whether such oped in an effort to protect

The author suggests that the frequency and severity of tardive dyskinesia in patients treated with neuroleptic drugs requires that informed consent be obtained from all patients receiving such treatment. The three basic conditions for obtaining informed consent are reviewed with discussion of some of the ethical problems encountered in the informed consent procedure. Most of these problems will be resolved if specific, written, informed consent is obtained from the patient, or his representative, within six a’eeks of initiating therapy. although in some cases questions may be raised about the very possibility of obtaining consent.

ALTHOUGH

TARDIVE

as a complication

DYSKINESIA

neuroleptic therapy was first described was recognized as a serious problem (2), only recently has the requirement sent

for

neuroleptic

therapy

been

have

memoranda cilitics.

informed neurolcptic regarding

adopted

to the directors Sovner

and

Received

of their

associates

(4) have

hygiene

the

lune

they

present

19,

1978;

are more stringent that such consent

may

medical-legal

revised

climate,

Nov.

2,

1978;

Nov.

Dr.

DeVeaugh-Geiss

is Assistant

Professor,

author

thanks

‘New York State nesia: A Guide December. 1977 randum number 2Connecticut

Ms.

Barbara

Department for Medical (attachment 78-1).

Department

nesia: An Emerging

of

and

Svoboda

for

her

Medical Problem

Health

Alert.

28,

Syracuse

conditions first

that

involves

about

an affected

prevail

the

with

person

re-

who

is

legally

ability

Such

persons

model, usually

i.e. from

arc typinformed

a pediatric by proxy,

appointed

guardian.

,

to

a relative

Although

this situ-

conditions there is no demonstrable and the judgment of a physician criterion on which the decision of

to give consent resides. to obtain opinions

is that therapy

dicated

benefit.

and

of potential

of predicting

which

it must

be

It is important from external,

of a competent is believed Since

patients assumed

there

to

person be in-

is no clean

will develop that

in dis-

tardive

some

degree

neuroleptic a presumed

of

drugs. Allow risk!

benefit ratio, recent epidemiologic studies indicate that the risk of tardive dyskinesia in people taking neuroleptic drugs is much higher than had been previously recognized (5, 6). Thus it appears that informed con-

sent

Dyski-

15.

would

neuroleptic

appears ©

in

individual’s

consent.

risk exists for anyone receiving though debate has focused on

in Psychiatry,” February

0002-953X/79/08/0959/04/$00.45

basic The

and to give

dyskinesia,

1978.

inherent

CONDITIONS

interested third parties. The second condition for whom neuroleptic way

assistance.

“Tardive

be raised

competency such instances

of Mental Hygiene, “Tardive DyskiStaffs of Mental Hygiene facilities,” to Division of Mental Health memoMental

CONSENT

arc three

many psychiatric cerebral pathology, may be the only

in be

of Psychia-

Staff Psychiatrist,

problems

ation is fraught with moral and ethical problems, this mechanism is recognized as having legal, moral, and social validity. It should be noted, however, that in

York Upstate Medical Center, 750 East

Adams St., Syracuse, N.Y. 13210, Veterans Administration Hospital. The

Department

ethical

of informed consent to persons with neuroleptic drugs.

BASIC

to consent.

or other

1978. try, State University of New

other

ically treated under consent is obtained

it is diffi-

accepted

THREE

be informed

that

than Ayd should

however, the doctrine to be treated

deemed incompetent to give consent. Certainly, there arc many brain diseases in which legitimate question

fa-

suggested

are,

There

through

mental

There

spcct

be obtained after because tardive time. The departYork’ and Con-

recommendation

that obtaining informed consent for treatment in actual practice, satisfy the need for proon both sides without engendering conflict.

THE

(3)

pose it is most

likely would, tection

applying who are

consent should be obtained after one year of therapy, and while they are more liberal the interval between instituting therapy and

obtaining consent, their recommendation

written. Given

this

have develfrom sub-

and protecting the patient from the doctor-may an ethical dilemma for the treating physician,

of

Ayd

guidelines physicians

sequent litigation (although Sovner and associates are explicit in their acknowledgment of the need for such protection) or to protect psychiatric patients from the hazards of treatment. While these potentially conflicting motives-protecting the doctor from the patient

in 1957 (1) and as early as 1968 ofinformed con-

articulated.

has suggested that informed consent three months of ncurolcptic therapy dyskinesia rarely occurs before that ments of mental health in New necticut2

DEVEAUGH-GEISS

American

be advisable drugs.

late Psychiatric

Because

in the

course

Association

for

all patients tardive

of therapy,

who

dyskinesia

postponing

receive usually

the 959

INFORMED

CONSENT

FOR

NEUROLEPTIC

Am

THERAPY

decision on two

J Psychiatry

/36:7, July 1979

to obtain informed consent may be justified grounds: the risk is minimal during the initial period of treatment, and the condition of the patient who is psychotic may interfere with his or her ability to give truly informed consent. On the former point, I would disagree with Ayd and Sovncr because I have seen two young men, aged 30 and 32, who developed tardive dyskinesia within 5 weeks of the initiation of neuroleptic therapy. in one case, the dyskinesia was reversible, but in the other it has persisted for more than one year. On the latter point, certain moral and philosophical questions arise, but assuming that the changes in thought process and content brought about

atose or delirious patient is frequently treated without consent and, once restored to a state of consciousness or nondelirium, either gives consent for continued treatment or withholds consent and the treatment is discontinued. In such cases, the restored, or normal,

by neuroleptic

looked whose means,

treatment

ed toward

are both desirable and direct‘reality’ orientation, one could consent procedures until the psychoIn this connection, 4-6 weeks of

a proper

justify delaying sis has remitted.

‘

‘

neuroleptic treatment will be sufficient to achieve this end in most instances. Patients who are refractory to treatment after this interval are likely to remain so for an extended period of time, and when drug treatment is still

deemed

advisable

could be obtained tor. This approach viewpoint

on

in these

cases,

legal

protection

for the represents

consent

proxy

a conventional

for

treatment

consent

of the

doc-

is

maintained

without

drugs

continued administration special type of ethical is obtained only after

been

achieved.

psychosis

sent

The

and

similarities

religious

between

conversion

as a person

whose

thinking

is not

dyskinesia

is known

to

be

caused

by

the

al review of the benefits and detriments will suffice to inform the patient properly

ofthe

brain

it is disputable.

Many metabolic and nutritional disorders may cause disturbances in thinking, perception, and behavior, but most ofthcse have demonstrable pathophysiology. Specific treatments will correct the pathologic processes and secondarily produce improvement in the behavioral disorders. Examples of such disorders arc thyrotoxicosis and pellagra. If functional psychosis represents a similar pathophysiologic process occurring in the brain, restoration of normal cerebral functioning by chemotherapy would enable the patient to give informed consent. Such a model for psychosis is currently only theoretical, however, and the evidence for this hypothesis is no

more

compelling

digms ment

of psychosis. that psychosis

than

that

for

many

other

pana-

960

presence

drug

worsening

with tardive assessed in

harmful may

such

Although

dyskinesia most cases,

aspects (10,

give

another

the

the

potential

1 1). Only

or withhold

instances,

when

ethical

disability

can be severe it has been

ofdiscontinuing

outweigh

treatment

may

poses

physician.

a very

consent

neuroleptic

continuing

and

unemotionof treatment so that

as he sees is given

is easily that the

treatment of

careful

consent

dilemma

associated

(9) and argued

hazards

treat-

reversible the existing

he

necessary. for

In

continued

treatment the severity of the movement disorder must be reassessed periodically (probably every three or four months) to maintain a current perspective on the benefit/detriment equation. It would seem essential also to provide a supervised drug-free period at least once annually to reassess the benefit side of this equation. In addition, consultation with external, disinterested third parties-ideally, a neuropsychiatrist with training and experience in the evaluating psychiatric cases.

and

movement

disorders-is

advisable

in these

Thus, while the analogous argurepresents a physiologic disorder

similar to endocrine disease or nutritional deficiency is attractive, the evidence seems insufficient to justify delaying informed consent procedures in all cases of functional psychosis until treatment has been successful. In this connection, it is often difficult to differentiate between delusions and peculiar or idiosyncratic ideas, or between thought disorder and political dissidence, as critics of Soviet psychiatry have suggested. Another model for treatment without consent exists

in the

of over-

controlled.

monstrablc

disease

be

The third condition necessitating informed consent for continued neuroleptic therapy is that of the compctcnt patient who already has a drug-induced dyskinesia and for whom continued treatment with neuroleptic drugs is deemed necessary or advisable. The

for the

organic

Thus a consent have

(7, 8), and it must be considered that the person thinking is controlled, by drugs or by any other may not be able to give the same type of con-

dyskincsia

‘

alter

remission

cannot

A

‘

that

of neurolcptic drugs. problem is raised when the objectives of treatment

with disordered and ‘delusional’ is to be informed and to give consent, but after being restored to rational and ordered thinking by chemotherapy, such a person is able to give consent. Although this may seem obvious and is taken as axiomatic in psychiatric practice, in the absence of de-

person unable

psychosis. thinking

usually

thinking. In functional psychoses, the restored, or rational, state often cannot be maintained without the

ment in such cases, so the risk ofpotentially dyskinesia becoming irreversible or of

psychiatric of

state

of acute

brain

dysfunction.

The

com-

RISKS PROC

ASSOCIATED

WITH

THE

CONSENT

ESS

One hazard of obtaining informed consent deserves mention, and this is best expressed by Alexander Pope’s maxim, ‘A little learning is a dangerous thing. Providing information about risks and benefits to an individual who lacks the comprehensive training and experience of the physician may frighten or otherwise discourage the patient from electing a relatively safe and therapeutic treatment regimen. Although this ‘

‘ ‘

Am

J Psychiatry

possibility

/36:7, July 1979

does

not

alter

the

IOSEPH

physician’s

obligation

to

obtain consent, it emphasizes the necessity for honest and unemotional review with the patient of the pertincnt information regarding a proposed treatment. A patient-physician relationship that is founded on trust and honesty will rarely fail to promote judicious dccisions

regarding

treatment,

even

when

such

treatment

when

ccpt the physician’s be a serious problem. opinion sician

can reinforce or even lead

the

patient

chooses

not

to ac-

recommendations, this need not External consultation or second thcjudgment to suggestions

ofthe primary of alternative

phyforms

of treatment that might be more acceptable to the patient. Finally, the patient is free to seek treatment from another practitioner whose expertise and therapeutic skills may be more congruent with his order needs, and a physician has no ethical or legal responsibility to provide

a form

of treatment

he does

not

recommend

describing

the

served, toms

and

drug

or

them and

treatment statement therapy be

quires sicians

enced

additional whose

consultation clinical

by personal

tient’s

family,

from

judgment

knowledge or

the

any

disinterested

is unlikely

of the

primary

other,

phy-

to be

patient,

physician

reinflu-

the

pa-

involved.

There is no absolutely satisfactory method of dealing with this difficulty and there is a recent trend to place the ultimate responsibility for such judgments in the courts.

Although

be accepted the physician medical

threats

care

this

method

is less

now as the only legally who is attempting in a climate

of malpractice

of conflict,

than

ideal,

it must

safe procedure for to prOvide proper controversy,

and

litigation.

CONCLUSIONS

In summary, it appears that all patients receiving ncuroleptic drugs are at risk for tardive dyskinesia and should be informed ofthis risk. Ideally, informed consent should be obtained before initiating treatment, and this can usually be done verbally through a general discussion of risks and benefits between the physician and patient. The best protection from subsequent litigation would be provi&ed by a written summary of the discussion that is read and signed by the physician and patient, although this is not always necessary. When

consent procedures are postponed for any of the reasons outlined above, it is advisable to obtain general written consent by the eid of the sixth week of treatment. Written informed consent is essential for patients who have had reversible dyskinesia in the past

or causing that there

find

that

by

observing

consent as outlined may be minimized. 1cm that is peculiar which

that

ob-

the

symp-

continued

while

them is no

drug

possibly

to become irrcknown effective

a

included.

further

conflicts regarding intherapy have been coyand the practitioner the

doctrine

of informed

above the potential for conflict However, I have observed, a probto patients with tardive dyskinesia

complicates

that

than

fact

symptoms

Most of the common ethical formed consent for neuroleptic cred in the foregoing remarks, may

disorder

between

for the movement disorder. In addition, regarding the need for continued neuroleptic and tle risks of discontinuing this therapy

physician.

more

the

worse stating

formed consent. In a recent survey

situation,

movement

the

mask

to treat a patient who chooses not to follow his recommendations. This problem becomes more complex, however, when the responsibility for such a decision is transferred to the representative of a patient deemed incompetent. It is in this context that the welfare and best interest ofthe patient may be obscured by the personal needs of involved third parties, including the This

of

of tardive dyskinesia is thought to be inshould be specific in

relationship

treatment,

may

making versible,

should

symptoms

the presumed

treatment

decisions

arc the patient’s responsibility. Although it could be argued that giving such responsibility to the patient might hamper the physician’s ability to render the best possible

or who currently have symptoms and for whom ncurolcptic therapy dicated. This consent procedure

DEVEAUGH-GEISS

the

matter

of 15 patients

of obtaining

with

in-

tardive

dyski-

nesia, I inquired repeated about the existence dyskinesia and specifically about the patient’s ness ofhis movement disorder. Seven ofthese consistently and repeatedly denied that they

of the awarepatients had ab-

normal

the

or most

enough

involuntary of

them

to cause

movements, had

some

despite

symptoms

difficulty

that

with

were

speech,

fact

severe

ambula-

tion, or coordination of ordinary motor movements such as those used in eating or dressing. Three patients stated that they were not aware of the involuntary

movements quired.

and The

movement Although

only

remaining

disorder. this may

noticed 5 patients

not

them

because were

aware

be a representative

I had

in-

of their

sample,

others involved in studying tardivc dyskinesia have also found that a considerable number of patients with movement disorders are not aware of their involuntary

movements, and some also deny the existence of the disorder. These observations raise the question of whether it is possible to obtain consent for ncuroleptic treatment in such cases because this would require the patient to consent to a risk for something he apparently believes does not exist. Further, in such instances, it is not at all clear whether one would be acting ethically or responsibly by continuing treatment or by discontinuing treatment. It seems that ethical problems such as those posed by tardive dyskinesia will require clarification along a

number in biological

of lines.

As more

psychiatry

of neurochemistry underlie certain ric syndromes

sophisticated unravel

some

investigations of the

and cerebral metabolism behavioral problems, many may come to be recognized

mysteries

that may psychiatas phys-

icochemical disorders for which specific treatments, hopefully with less devastating side effects than neuroleptic drugs, are available. This transformation from psychiatric disorder to medical disease entity will as-

961

INFORMED

sist

CONSENT

in resolving

FOR

some

NEUROLEPTIC

of the

current

Am

THERAPY

ethical

dilemmas.

The frequency of prescription of and long-term maintenance with neuroleptic drugs will probably diminish as awareness of problems such as tardive dyskinesia increases. Better definitions of “informed consent” are needed, particularly in the obscure areas delimited by such questions as the following: Can a person whose thinking itself is modified by a treatment properly give consent to continuing that treatment, especially if it could reasonably be expected that discontinuing the treatment would result in refusal to consent? Is a person who has been disabled by treatment able to give informed consent to continue treatment and accept exposure to the risk when he denies the disability and, implicitly, the risk involved?

2.

3. 4.

5. 6.

7.

8. 9. 10.

REFERENCES II. I. Schonecker

M:

Em

eigentumliches

bei megaphenapplikation.

962

Nervenarzt

syndrom

im oralen

28:35, 1957

bereich

J Psychiatry 136:7, July /979

Crane GE: Tardive dyskinesia in patients treated with major neuroleptics: a review of the literature. Am I Psychiatry Supplement, February 1968, pp 40-48 Ayd FJ: Ethical and legal dilemmas posed by tardive dyskinesia. International Drug Therapy Newsletter 12:29-36, 1977 Sovner R, DiMascio A, Berkowitz D, et al: Tardive dyskinesia and informed consent. Psychosomatics 19:172-177, 1978 Jus A. Pineau R, LaChance R, et al: Epidemiology of tardive dyskinesia. Part I. Dis Nerv Syst 37:210-214, 1976 Asnis GM, Leopold MA, Duvoisin RC, et al: A survey of tardive dyskinesia in psychiatric outpatients. Am I Psychiatry 134:1367-1370. 1977 Szasz IS: The Manufacture of Madness: A Comparative Study of the Inquisition and the Mental Health Movement. New York, Harper & Row. 1970 Sargant W: Battle for the Mind: A Physiology of Conversion and Brainwashing. New York, Harper & Row, 1971 Casey DE, Rabins P: Tardive dyskinesia as a life-threatening illness. Am I Psychiatry 135:486-488, 1978 Gardos G, Cole JO: Antipsychotic therapy: Is the cure worse than the disease? Am I Psychiatry 133:32-36. 1976 Prien RF, Klett Ci: An appraisal of the long-term use of tranquilizing medication with hospitalized chronic schizophrenics. Schizophr Bull 5:64-73, 1972