Informed consent represents the single most important issue in the
delivery of health care. Informed consent exists only when there is full
disclose of known relevant information and
known risk presented to the patient in
a manner that they can understand. There are patients who did not understand
that the surgical "mastectomy" they agreed to undergo involved removal of their
breast. The text, shown above, a work of fiction by Roger Radford,
hit close to home on the subject of adhesive
arachnoiditis; a present and real worldwide health care problem.
In the "real world" in which we exist there are often procedural
modifiers which influence "full disclosure." Some of
these have legitimacy and some do not. It is not unusual to see a
court setting as the venue by which resolution of these issues is
being attempted. One such situation is whether a medical treatment or surgery being
recommended or performed is "accepted", "standard" or
"approved" and from whence the
authority to determine this exists.
The challenge in determining "informed consent" becomes even
greater when it becomes apparent that there are significant disparities
in the definition of the terms being used. In fact this confusion
may be taken advantage of this to
promote secular interests and agendas. Medical malpractice cases based on
informed consent issues (rather than negligence) as sometimes considered
to represent the
"soft" side of forensic medicine. This litigation is,
however, an
important "safety net" for society. It is unfortunate, but
true, that informed consent sometimes been subject to serious abuse for
the purpose of personal gain. Examples of such are failure to make
patients aware of minimally invasive uterine artery embolization instead
of surgical hysterectomy, minimally invasive aneurysm coiling instead of
open cranial surgery and reconstructive spine surgery as opposed to
multi-level pedicle screw and rod "fusions."
It is true that the practice of medicine has never related to certainties.
Treatment is based on best information. Evidence based medicine
consists of careful clinical observation and experience combined with the best scientific
data available.
The notion that there is no empirical basis upon which to draw valid
inferences and render reasonable judgments in the treatment of patients
is false. On the other hand there also exists important scientific
information which never seems to make itself known to physicians responsible
for patient care. As medical practice progresses in time it becomes smarter and
learns of risk factors which were previously unknown or unappreciated.
Sometimes this knowledge is privy to some who purposely do not release it or
act to obfuscate it for personal gain. The actions of the tobacco
industry, over the past 50 years, makes this point. Yet, an important landmark in
forensic medicine is "what was known, and when was it known" as a determinant
of informed consent.
An interesting example of this is the issue of chronic respiratory disease
related to exposure to asbestos fibers. There is a great deal of
ongoing litigation
against manufacturers of such products. For the most part
exposure to asbestos occurred during a period of time when neither the
manufacturers, the workers or their physicians were unaware of asbestos
toxicity. Where the are the benchmarks? How can we create expectations
which are smarter than we are?
The phenomenon of "managed
care" has introduced additional challenges to the concept of
"informed consent." In their quest to justify denial of coverage
for their subscribers many
third party payors, seeking an opportunity to say "no" to
treatment being recommended for a patient, often use the term "not
proven" or "experimental" as a means of denying coverage.
What is the legal ramification of this to the physician recommending
treatment? What are the legal ramifications when care is denied and
an alternative treatment goes "wrong." Who has the legal
responsibility? Well, up-to-now the physician has been left
"blowing in the wind" on this issue. The "worm "
is,
however, "turning." Now that the unique immunity
against legal suit provided by ERISA
is in the slow process of being stripped away by the courts the health
care "playing field" may, finally, become more level.
A level playing field is particularly needed in the arena of informed
consent because full disclosure of risk is typically taken to be a medical
"right" in the United States (as well as a primary
"standard of care"). This is an interesting phenomenon
because this concept varies considerably throughout the world (as demonstrated by the
Burton Experience in the Soviet Union
in the 1970s). In the real natural world there are no "rights" for animals (astutely
pointed out by Charles Darwin). If each of us were placed naked in the
center of a
dense tropical jungle and we had to fend for ourselves we would discover
what Darwin had in mind.
As the human race evolved on planet earth
only those humans who possessed power had "rights." In medieval times only the
monarchs and the nobility held "rights. When the
United States was young Thomas Paine and James Madison observed that
rights were divided into "natural rights" (i.e. freedom of
thought and speech) and "civil rights" (i.e. the right to trial
by jury). Informed consent is a civil right", more specifically
a conceptual "patient right." Other important
conceptual "patient right" is that of the expectation of being
provided with respect and consideration from a heath care system.
The Burton Report® is a strong
advocate of
real informed
consent. This requires the clear presentation, to a patient, of all
significant potential risk. The Burton Report® is also a strong
proponent of providing patients respect and consideration.
Another position of Burton Report®
is against the banning of any drug or therapy.
Banning is the making of rules "which are smarter than we
are." One never knows when a toxic substance can be of benefit
(i.e. thalidomide and botox). The better approach for the patient, and society, is
real informed consent.
Clearly, the United States is the world
leader in regard to disclosure of risk to patients. Even so there continues to be serious inadequacies
and transgressions of this process which need attention.
This is, at times, difficult to address because the concept of "rights" in the United States
has burst asunder to finally reach a level of true frivolity. Perhaps this should not come as a
surprise in a society where legal suits have become, as George F. Will has
observed: simply a part of "a great American growth industry,
litigation that expresses the belief that everyone has an
entitlement to compensation for any unpleasantness."
When one considers all the attention which has been focused on the
issue of informed consent over the past few years it may seem surprising
to learn that important areas of medical diagnosis and treatment still exist
where full disclosure of risk has never been provided in the past and has continued to be seriously deficient in the present.
A look at the record confirms the point. Only recently have the adverse effects of particulate
radiation, exposure to toxic chemicals and cellular damage resulting from
nicotine and carbon monoxide poisoning (from cigarette smoking) been
disclosed. It is important to note that most of this has occurred only as the result of
litigation reflecting plaintiff rage and not as a result of governmental or
medical intervention.
A good case in point is that of cigarette smoking. From a medical
standpoint, the toxic effects of cigarette smoking appear to represent the single
most adverse known chronic health liability, from an external source, directed to
the human body. Remarkably, it has only been since 1997, when, as a direct
response to legal actions, the actual ingredients of some cigarettes were
finally disclosed to the public.
Once again, were it not for the existence
of legal process to unravel the cover-up contrived by the tobacco industry
the
release of this important information might never have occurred. One
indication of society's patience wearing thin was the shock therapy
administered to the tobacco industry on June 7, 2001 when a Los
Angeles jury awarded $3 billon in punitive damages to a longtime smoker with
lung cancer. A key element in the resolution of this case for the plaintiff
was the introduction of a 1972 memo written by a Tobacco Institute executive
pointing out how the tobacco industry had successfully undercut public
health concerns about the cancer risk of smoking by "creating
doubt...without actually denying it" (Geyelin
M: Former Two-Pack-a-Day Man Finally Satisfied His Urge to Sue, Wall St.
Jour., June 8, 2001). The fall-out from this
decision continues with punitive damages being awarded against the tobacco
industry for continuing "nefarious" behavior (Judge
awards $15 million in punitive damages in tobacco case against R.J.
Reynolds, Associated Press, June 22, 2002).
Most interested patients in the United States today are reasonably
cognizant of risk factors as more trustworthy information continues to
appear on the internet. There are, however, a number of areas
where informed consent remains, quite remarkably, almost absent. In fact there are
a number of examples of serious health risks which have continued unabated over
many years (and sometimes decades). Many of these are still unassociated with adequate public disclosure and
few in the legal profession have yet "stepped up to the plate"
to assist in assisting the public interest.
One of the most serious examples of this
has been, and continues to be, the disabling complications resulting from the introduction of foreign body substances into
the subarachnoid space for the purpose of myelography as well as ill-advised
epidural steroid
injections. The disease complication is that of
clinically significant adhesive
arachnoiditis. This particular entity
represents one of the most flagrant examples of a ongoing world-wide serious public
health problem due to many years of industry misinformation and
cover-up. Patient suffering secondary to adhesive arachnoiditis serves as a frightening
example of an area where, at the beginning of the 21st century it is difficult to find a single patient
who has ever been provided
with real informed
consent in this area.
What about the physicians? As adhesive arachnoiditis expert Sarah
Smith points out:
"What concerns me is that if the person informing
the patient is themselves poorly or inaccurately informed then how on earth
can consent ever be truly informed?"
In association with
this remain remarkable
examples of continuing medical ignorance relating to commonly performed
procedures. Medical informed consent is
unlikely when the usual material
provided to the public, by their physicians, ignores the most
significant risk factors?
No area of informed consent is more important than that of medical research
and the involvement of human
subjects.
How can patients know the risks if they are basically unknown to
science as well as the medical profession? Unquestionably, gene research will play a very important role in future
medical therapy. Gene therapy represents a challenging voyage into uncharted
water where the benefits for all mankind may be historic. How do we know what we don't know, and how does
informed consent fit into this picture?
Summary:
It is clear that there is no risk-free state in medicine. What then are
the risks of surgery? In the field of spine surgery all patients run the
risk of dying, being paralyzed, experiencing a nerve injury, wound
infection, medical problem, drug reaction, etc. Actually most of these
serious risks also exist when the patient drives to the hospital. As an
example, the United States government reported that in 1998 alone 41,480
people died from auto accidents.
Informed consent is an essential requirement for the well-being of any
modern health care system in the 21st century. Informed consent is based on full disclosure of known
significant risk (the easy
part). Full disclosure of all "relevant
information" is the murky component, particularly from the standpoint
of jurisprudal machinations and contrived governmental anomalies.
Informed consent litigation has created a great deal of "busy
work" for attorneys. Much of this litigation has wasted large amounts of time, talent and resource which could have been put
to better use in the courtroom by pursuing more important areas of societal
need. The need the create clearly defined requirements for patient protection,
taking into account
the rapidly changing landscape, is an important priority for the 21st
century.
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