Knowledge is understanding gained through experience or study. In medicine it is both experience and study (science) which provide our understanding. Information is the means by which we communicate this experience. The avowed purpose of medicine is to transmit valid information for the purpose of “making sick people better.” The challenge to our health care system is to keep this ethic alive. A significant part of the ongoing challenge is that the quality of information varies considerably and information is often “spun” to achieve hidden agendas specifically related to denying patient care in order to improve corporate profitability.
Sometimes just shining of a beam of light on supposed good information can provide remarkable insight. One of the best scientifically controlled investigational medical studies ever published was in regard to the treatment of seizures associated with epilepsy. It involved creating eleptogenic neurons in animals and then studying the effect of parenterally administered drugs in controlling the seizure activity of these neurons which were being directly monitored by microelectrodes placed directly in these neurons . The study concluded that parenteral diazepam (valium) was effective in controlling seizures while parenteral diphenylhydantoin (dilantin) was not (when in fact the dilantin was clinically most effective in this regard) and on the basis of these repeatable results the investigators dismissed dilantin as a clinical treatment for seizures. Because the study only monitored the neurons made epileptogenic, and not neighboring neurons, the conclusions drawn were wrong because parentally administered dilantin was actually quite effective in terminating acute seizures by blocking their propagation between neurons and not by acting directly on the epileptogenic neuron itself . This study represented a classic example of a careful controlled scientific experiment leading to erroneous conclusions. This scientific information but proved to be a disservice for all patients suffering from acute seizures because, based on these data, dilantin was subsequently not approved for parenteral clinical use for seizure control.
The Many “Flavors” of Science
“Science” and the “scientific method” are not infallible. One of the most crucial, and common, transgressions in our society today is the not infrequent pandering of the term “scientific” as a means of achieving hidden agendas.
For almost two thousand years the “mainstream” of medical thought was Galen of Pergamun’s (130-203AD) textbook of medicine. Not only was it “mainstream” it was generally agreed, until the Renaissance in the 13th century, that there existed nothing else worth knowing. When the Galenic period ended the “golden age of medicine” began. The renaissance in medical thinking continued to the 20th century when it reappeared as the “New Galenic Era” being advanced under the guise of “guidebooks” and “standards” of medical practice.
Science may not be sacred but it is certainly wondrous. Many incredible advances of science continue to pass before our eyes. Science has now stepped in front of religion and philosophy as the dominant intellectual force in society. The down side of this is the unquestioning reverence the word “science” tends to promote. This scenario is eerily reminiscent of the “Great and Imperial Oz” crouching behind a Emerald City curtain in the 1939 hit movie “The Wizard of Oz.” It almost seems that the wizard’s statement to: “pay no attention to the man behind that curtain” remains most appropriate today.
What then is “science”? It is supposed to be a method of investigation which includes careful measurements, repeatable experiments, and an open minded (yet skeptical) attitude requiring that all claims undergo careful scrutiny. Science will always be imperfect. Even the best of science can be easily influenced by a number of factors; the “Hawthorne Effect” represents a good example of this.
The sad reality is that “science” comes in a number of different “flavors” which reflect a spectrum of different things (not necessarily matching the stringent definition above). To begin with there is “real” or “good” science, then there is “poor” or “junk” science and sorrowfully, science which has been purposefully fabricated. It is important to hold science to the test and determine the “flavor” of science actually in force on the “playing field” of life. Typically, however, the questions come after, rather than before, the fact. Let’s explore this subject a little more:
Real Science– This is indeed the method of investigation which includes careful measurements, repeatable experiments, and an open minded (yet skeptical) attitude requiring that all claims undergo careful scrutiny.
Suppressed Science– Good science is not of much value to society if it is has been suppressed. Prominent examples of the suppression of investigation data abound. The tobacco industry successfully suppressed important scientific information regarding cigarette smoking over a period of 35 years. The manufacturers of iophendylate (Pantopaque® and Myodil® used for spinal myelography) suppressed important information regarding toxicity for an equal period of time. Scientific surveys and polls are also open to suppression; a 1998 study on the cost-effectiveness of Health Maintenance Organizations in Minnesota commissioned by the State Human Services Department was found to have been suppressed. The excuse for suppression given was that the study contained “flawed data” but internal department documents suggested that if the reports had been released to the public their disclosure would have proven embarrassing for the politically powerful HMOs. If one looks carefully at many patient information polls one sees that a great deal depends onthe questions being asked. Patients may be asked only the questions the inquirer wants answers for.
“Orphan” Science– Good science which is simply not given the attention it deserves. Scientific data on the dangers of toxic chemicals and effects of radiation on the human body have often been given short shrift based on a myriad of excuses; none of which have related to the welfare of the affected individuals.
Junk Science– Inspired by the lure of large monetary rewards scientific “quests” are sometimes initiated by the legal profession to come up with science to match the need. The silicone breast implant cases with their multi-billion settlements have reflected upon the worst of “the scientific method.” “Scientific contributions” based on hidden agendas are not infrequent. The extensive and expensive “pedicle screw” litigation has confused the public because “science” was interpreted as being the same as contrived governmental procedural dictums associated with informed consent issues.
Fabricated Science– Fortunately it is an uncommon circumstance when scientists and medical professionals fabricate data. It does, however occur. The most common examples of this are data falsified in clinical studies of drugs and devices. Some physicians have fallen prey to the “easy” money to be made in fictitious or invalid drug studies. The issue of the biologic effect of high voltage power lines on animals and humans has been, for many years, a highly visible emotional issue. The fact that many of these concerns were fed by falsified data has come as a shock to many truly concerned individuals.
Clinical Studies, the Process of “Peer Review”, “Evidence-Based Medicine”, and Other Interesting Topics
Randomized, double-blind, controlled and prospective clinical studies represent the highest order of “good” clinical information. There is no disagreement with this observation. The truth is that there are precious few of such studies in medicine. This is particularly true in the field of spine care. The “sacred alter” of clinical investigation and subsequent determinations are now the entities of “peer reviewed” publications and “evidence-based practice medicine.” These terms have now become the “magic wands” for creating instant authority with the expectation that no further inquiries will be made.
“Proven” and “Unproven”
In the “wonderful world” of hidden agendas the terms “unproven” and “experimental” are often used to achieve influence regarding patient care. The original meaning of the word proof meant to test. Basically it means validation by the scientific process repeated, over a period of time.
The Use of Information in the Courts
As surprising as it seems it appears that the judicial system in the United States seldom uses, and may actually avoid, published good medical science because informal tradition and formal statutes dictate that the system use live witnesses. Part of the reason for this appears to directly relate to the observation that a well documented scientific foundation for contemporary medical practice still does not exist (which is true). This situation clearly places the physician in an ethical dilemma when there is a requirement to provide valid information. For this reason the information provided needs to be identified as to source and reliability. It should also be incumbent on the provider to also routinely disclose any potential conflict of interest or bias.
Sharon Begley has pointed out in the Wall Street Journal that “legitimate scientific evidence has also become rarer” in the courts. “Judges are dismissing testimony by physicians as anecdotal, setting standards for scientific evidence higher than what doctors and researchers use, and barring testimony when scientists in different disciplines disagree” (Begley S: ‘Junk Science” Ban Also Keeps Jurors From Sound Evidence, Wall St. J., June 27, 2003).
Useful Information and Utilization Review
In 1987 and 1988 the Health Program at RAND, Santa Monica, California published a series of articles on the appropriateness of a number of medical procedures which were performed between 1979 and 1982. These data suggested that that a significant percentage of such procedures were unnecessary. Even though further clinical investigation of thismethodology did not substantiate the RAND observations the effort was pounced upon by many to justify stringent utilization and peer review and to continue to expend significant resource in this type of effort. By 1992 there were 350 review firms nationwide in the U.S. performing utilization review on about 80% of Americans receiving medical care. The concern about replacing medical care costs with administrative costs was reflected in a 1990 survey performed by the inspector general of the U.S. Health and Human Services Department. This department reviewed 500,000 cataract operations funded by Medicare. They demonstrated, in this study, that the United States paid $13.3 million to utilization reviewers to save $1.4 million in possibly unnecessary surgery.
Despite the well documented fact that the cost of utilization review far outweighs any potential benefits, this approach has, until recently, continued to flourish in the United States. It has become increasingly evident that the primary reason for this continuance has related more to a desire, by third party payors to justify denial of medical coverage and care rather than to truly examine the merits of the therapy being recommended. With the advent of third party payors potentially being held legally responsible for their actions we have finally begin to see organizations such as the UnitedHealth Group begin to discard their utilization review departments.
The terms “Experimental” and “Investigational” have been the subject of particular abuse. The term “experimental” has not been infrequently misused, even by those who know the difference, as a means of purposeful “shock therapy.” This action is contrived specifically to create an association, on the part of the observer, with the mental image of humans as “guinea pigs.” The act itself is a play on the particular sensitivity, in today’s world, with the abuses in human experimentation which occurred in World War II.
The generally accepted definition of experimental and investigational are:
Experimental: refers to therapies and procedures where basic safety and efficacy have not yet been determined (i.e. by cell culture or animal studies). Experimentation should never involve the use of human subjects unless Nuremberg Code criteria are met. Human xperimentation abuse was not uncommon during the 20th century.
Investigational: when basic safety and efficacy have been demonstrated by the experimental scientific process the investigational phase begins. This typically represents the clinical phase of a scientific study involving well controlled, patient groups as a prelude to the therapy or procedure becoming a standard therapy. A harmful therapy can never be considered a “standard” therapy even if it is commonly applied.
It is sad to observe that the abuse of the term “experimental” has become so rampant that it has been reduced, particularly by its use in managed care, as being reduced to “nonsense.” It is clear that we must, at this point in history, begin to focus more attention on the meaning of words.
Expert Medical Testimony
In addition to providing information regarding “standard’ or “accepted” forms of therapy physicians are often called upon to provide expert witness testimony in a deposition or in the courtroom. There exists a legitimate concern today that sometimes the information presented is not of good quality and may be biased because of potential conflicts of interest. In an adversarial system of law each side produces its own witnesses and information and it is the responsibility of the court to judge (and rule) on this. More frequently the courts are becoming involved in issues relating to technology assessment as applied to patient care. A specific example of this are decisions made in regard to patient eligibility for such technologies, as well as court-ordered reimbursement of expensive treatment modalities. Typically, sources of information are many and range from the scientific to the anecdotal. The abilities of the court, without its own experts to advise are sadly quite limited.