Informed consent represents the single most important issue in the delivery of health care. Informed consent is present 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 actually involved removal of a breast. The text, shown above, authored by Roger Radford, hits close to home on the subject of adhesive arachnoiditis; which continues to be a present and real worldwide health care problem.
In the “real world” 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 to promote secular interests and agendas. Medical malpractice cases based on informed consent issues (rather than negligence) are sometimes considered to represent the “soft” side of forensic medicine. Although clearly excessive medical malpractice litigation does represent an important “safety net” for a patient.
It is unfortunate, but true, that informed consent is sometimes been subject to serious abuse for the purpose of physician 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 excessive and unecessary multi-level pedicle screw and rod spinal “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 fortunately tends to become smarter and learn 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.
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 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 was pointing out.
As the human race has evolved on planet earth only those humans who possessed power had “rights.” In medieval times only the monarchs and the nobility had “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 all patients with 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 often needs 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?
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, failure of treatment, 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 the year 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, remains an important priority.