By Dr. Gary L. Deel, Ph.D., J.D.
Faculty Director, School of Business, American Public University
This is the eighth article in a 10-part series discussing the duties of American medical professionals to disclose complementary and alternative medical treatments to patients.
In the previous part, we discussed the two perspectives that courts typically employ in evaluating materiality — the patient perspective and the physician perspective. And it is clear that each has its own respective advantages and faults.
The problem with both of these approaches lies in their nature as subjective perceptions from the viewpoint of one party superseding the viewpoints of another. Therefore, it would stand to reason that a less problematic approach might entail the use of scientific testing to establish an objective standard that does not take into consideration the motives and opinions of the individuals involved. Enter clinical trials.
Clinical Trials in Controlled Environments Are the Highest Level of Evidence in Medicinal Research
Clinical trials, otherwise known as systematic reviews and meta-analyses of randomized clinical trials in controlled environments, currently constitute the highest level of evidence in medicinal research. Such testing typically takes months or years to complete.
But through the use of controlled human subjects in a controlled environment, medical researchers can isolate the effects of treatment on a study sample. That can lift the veil surrounding many scrutinized medicines to determine with the closest degree of accuracy what is fact and what is fiction regarding different methods of treatment.
Clinical trials are classified in four categories by purpose:
1. Treatment trials are designed to test the efficacy of a treatment in mitigating a particular disease or ailment.
2. Prevention trials, likewise, are designed to test a particular treatment’s efficacy in reducing susceptibility to a particular condition.
3. Early detection or screening trials look for new ways to identify diseases and illnesses before they show symptoms.
4. Diagnostic trials test new ways to more accurately and earlier detect medical conditions.
The Vast Majority of CAM Treatments Are Remedial and Therapeutic, Rather than Diagnostic
The vast majority of complementary and alternative medicine (CAM) treatments are remedial and therapeutic in nature rather than diagnostic, so they would most commonly be classified as treatment and/or prevention trials. Trials are also usually conducted in three phases.
Phase I involves testing a given treatment in small groups of people, with a primary focus on evaluating safety and adverse effects. Pending satisfactory safety results in Phase I, a treatment trial would continue to Phase II, where it would be tested on a larger population with the focus shifted to potential usefulness, dosages, and other characteristics.
Only if results are still positive will the treatment be elevated to Phase III. This phase involves the administration of the treatment to hundreds or thousands of test subjects. Researchers often compare the efficacy of a treatment during Phase III to that of other existing alternatives, and they refine their data on results and any side effects.
Once again, it is important to note that, depending on the time investment required to measure actualized results, these trials can take years to complete. Administrative procedures required of testing organizations and enforced by institutional review boards before any work can actually be done include the outlining of safety precautions, the identification of appropriate samples, and — in a twist of irony — the attainment of informed consent from test subjects. These steps can substantially delay the work being done.
One of the Biggest Advantages of Clinical Trials Is Objective Fairness
One of the biggest advantages of utilizing clinical trials as a legal standard over the status quo (subjective materiality tests, discussed in part VII) is the objective fairness of the testing itself. Clinical testing often involves completely random samples to ensure no bias in selection. Furthermore, the tests are usually conducted with the use of a placebo in a certain portion of the survey sample to remove the element of cognizance of treatment among the subjects.
Finally, as a further step to ensure the objective accuracy of results and removal of any biases, most clinical trials are conducted under what is known as “double blind” conditions, whereby neither the researchers nor the test subjects know which members of the survey sample have been given the actual treatment and which have been given the placebo. Obviously, this arrangement would be more difficult when testing overt behavioral CAM treatments like yoga.
But steps could still be taken to ensure that results are as accurate and unbiased as possible. For these reasons, clinical trials are most conducive to the achievement of an impartial determination of the efficacy of a particular treatment.
As the majority of our medical industry investments lies in the realm of allopathic treatments, the influences that regulate conventional medicine also manipulate — and to some degree control — clinical testing initiatives. This is due to the enormous expense involved in such research. Thus, it comes as no surprise that, while a few CAM treatments have undergone clinical testing at a comprehensive level, many others have not been recognized by the allopathic medical community to the extent necessary to fuel such efforts.
The National Center for Complementary and Alternative Medicine (NCCAM) has funded over 1,200 clinical trials for CAM treatments since its inception in 1988. But much funding and work still needs to be done to support what little hard data exists on most complementary and alternative treatments.
It is all too common that a new prescription drug, poised to bring billions in revenues to big pharmaceutical companies, will receive priority over alternative practices that might be helpful to patients, simply because those practices serve no benefit to — or perhaps even take away from — the bottom line of such businesses.
As mentioned earlier, CAM includes dozens of types of different treatments that vary dramatically in their characteristics. However, for the sake of cohesiveness and the feasibility of reporting, this series looks only to a few of the alternative medicinal practices under the Traditional Chinese Medicine (TCM) sub-category discussed in Part II, in order to provide a sufficient example of the varying levels of credibility currently established within the CAM world.
In the next part of this series, we will analyze several examples of TCM treatments and current research in clinical trials to investigate them.
About the Author
Dr. Gary Deel is a Faculty Director with the School of Business at American Public University. He holds a J.D. in Law and a Ph.D. in Hospitality/Business Management. Gary teaches human resources and employment law classes for American Public University, the University of Central Florida, Colorado State University and others.