01-24-2007, 02:14 PM
Note: this is not a disclaimer that the Scientific Method / Double-Blind experimentations are conclusive (and has indeed made many contributions). Rather, it is a direct statement providing concrete examples of where the Scientific Method fails to always provide unbiased results even in double-blind experiments, while addressing the complex human organism.
It shows explicitly why "the human body has to be conceived of as being entirely separate from the mind and from the emotions."
If a person who unconditionally believes the Scientific Method is unassailable reads this carefully, and lays aside personal feelings and convictions, this person will understand why it's not possible to always get unbiased trial results with something like the Bates Method using the current RCCTs (Randomized Controlled Clinical Trials). In fact, this article deals a cruel blow to the validity of the Scientific Method and its clinical trials as an appliance for every aspect of the complex human organism. In the sense that it works for some aspects and doesn't for others.
---------------------------------------------------
The fallacy of an assumption of simplicity 28 June 2003
Lawrence J. O,Brien,
retired health plan CEO
1200 N. nash Street #535,
Arlington, VA 22209 USA
The fallacy of an assumption of simplicity
Under the stimulus of a ridiculous idea like the ̬̉super pill̬̉ as a basis for adult humans to prevent disease and achieve health and long life, an Editorial like this in your highly respected Journal ought to first dissect what is really happening in contemporary medical experimentation. The conclusions of the meta-analysis that you cite are flawed because the clinical trials they are drawn from are fundamentally flawed. In an experiment conducted on the basis of classical scientific method the guiding presuppositions are that a specific cause is followed by a specific effect; that this effect can be predicted on the basis of an empirical understanding of its cause or causes; and that knowledge of the specific causation can be derived from knowledge of the effects. The fundamental error that calls into question conclusions being derived from an enormous number of randomized controlled clinical trials (RCCTs) being undertaken in the United States and elsewhere is that virtually every one of these medical experiments relies heavily on an ̬̉assumption of simplicity.̬̉ Any analysis of human organisms that depends upon an assumption of simplicity can lead to none other than erroneous conclusions, because these organisms--quite apart from their fundamental idiosyncrasy--have evolved as one of the most complex living systems to be found in Nature. As soon as an assumption of simplicity enters into a clinical trial or other experiment that involves human bodies, any claim that the trial or experiment is scientific becomes fraudulent. Simply put, it is impossible to hold that a study of human organisms can have anything at all to do with a notion that these organisms are simple. Thinking that human organisms can be meaningfully studied on the basis of an assumption that they are simple would represent a high point in intellectual bankruptcy. Most unfortunately, conventional medicine in the United States has not understood this very plain matter of fact. As a result, clinical trials and other medical experiments that are demonstrably rooted in a flawed idea--the assumption of simplicity--are being launched at a furious pace. The victims of this folly on the part of the medical profession would be difficult to quantify with accuracy, however the entire population is placed at risk through this radical and foolhardy burst of experimentation, most of it paid for with taxpayer funds.
The requirements of the scientific method have been traditionally defined as: ̬̉[P]rinciples and procedures for the systematic pursuit of knowledge involving the recognition and formulation of a problem, the collection of data through observation and experiment, and the formulation and testing of hypotheses.̬̉ (Merriam-Webster's tenth edition). The ability to precisely replicate an experiment on demand is an essential element of the scientific method.
In the face of the inescapable fact of overwhelming organismic complexity, biological science must proceed to make matters intelligible by describing what the structures and processes of an organism are, and how an organism does what it does. The scientist must begin by making certain that everything has been taken into consideration, and that nothing has been omitted from consideration. In classical scientific method, a theory or generalization is formed from empirically observed facts that are derived by the use of inductive and deductive reasoning; next, consistent connection must be demonstrated between and among the assembled facts, as well as with a body of systematic generalizations derived from other facts already accumulated and verified. Then, both the empirical and the logical implications and consequences that these ̬̉new̬̉ facts may have for the pre-existing body of systematic generalizations must be drawn out in specific terms; the ̬̉new̬̉ facts and any ̬̉new̬̉ generalizations must then be systematically and empirically verified and justified; and, finally, it must be shown that all of the ̬̉new̬̉ facts can be deduced, quantified, predicted, and replicated on the basis of the extant systematic body of generalizations.
The American philosopher and educator John Dewey once observed that the greatest and most pervasive fallacy of human thinking is the neglect of context. Medicine's methodologies in the design and conduct of its ̬̉gold standard̬̉ clinical trials constitute a striking example of this fallacy at work. Technological medicine's first mistake has been its misperception of the ̬̉problem̬̉ about which knowledge is being systematically pursued. Its dominant and entirely erroneous conception of the human organism--the subject and the object of all medical inquiry--is that it is most like a clockwork, a machine. Although this remains in place as American medicine's most controlling and unquestioned paradigm, the concepts of clockworks or machines as useful analogies for the human organism can be seen to be entirely inappropriate as the basis for describing what the structures and processes of an organism are, and demonstrating how an organism does what it does. By its reliance on the assumption of simplicity, twentieth century technological medicine has most certainly neglected the context within which any legitimate inquiry involving the human organism must take place.
Today, many physicians believe that the double-blind study rises to the level of a ̬̉gold standard̬̉ because it results in ̬̉objective, evidence-based proof̬̉ on the basis of which subsequent medical practices may rationally be defended. However, since the object of medical inquiry is the human organism in all of its complexity and idiosyncrasy; and since there is no alternative to the admission that far more is unknown than is known about the inner workings of human organisms; it is plainly an unproven belief to hold that all RCCTs result in knowledge about the treatment of human organisms that is so ̬̉completely determined by the objective evidencẻ̬ as to thereby be rendered certain and unassailable.
The fact that the science of medicine must be accepted as being a science of complexity, because its subject matter is the human organism, does not mean that it will never be possible to experimentally isolate a specific chain of causality to explain or to treat some abnormality of the human body. As complex and idiosyncratic as medicine's basic subject matter is, there are some instances in which cause and cure turn out to be related one-to-one. But it does mean that, in human experimentation, we must expect specific etiologies of this variety to be very rare occurrences, very much the exception and not the rule. To qualify as science, the study of human organisms must always be rooted in the recognition of the fittingness of Nobel Laureate Sir James Black's conclusion that, in studying human organisms, ̬̉we have entered the world of quantum theory, in which the whole is enfolded into each part and each part is enfolded into the whole, as in a hologram.̬̉ Whenever the specific subject matter of an RCCT is inherently more complex than a theory of specific causality could scientifically cope with, which will most often be the case in a clinical trial involving human organisms, it would thereby be demonstrable that no outcome of the trial could possibly be justified as representing ̬̉the full collection of impersonal and objectivẻ̬ quantitative evidence, but would instead be a result of an unsubstantiated personal belief by the investigators in the completeness of their experiment. This means that, except for those rare exceptions when a ̬̉specific etiologỷ̬ basis for a trial can be conclusively demonstrated to be scientifically valid, the ̬̉gold standard̬̉ clinical trials in use by conventional medicine today are based principally on the subjective and often biased beliefs of the designers of the particular RCCT--that is, on acts of faith by investigators that cannot possibly qualify as scientific evidence. For those who study medicine's subject matter from an organismic point of view, then, the ̬̉gold standard̬̉ proofs claimed to be issuing from the plethora of RCCTs being conducted today can rarely be accepted as being based upon ̬̉the full collection of impersonal and objective evidence,̬̉ as leaders of the American medical guild such as Arnold S. Relman, MD would have us believe. In a public forum held in Arizona during April 1999, Relman said the following:
"Medical science teaches practitioners to look for objective evidence before adopting a clinical method. ...All clinical biases and preconceptions, whether in alternative or conventional medical practice, must fall before the objective evidence, and we should be assiduous in seeking such evidence to improve our practices. ...At the least, [physicians] owe their patients their best professional advice, based on the most reliable information."
These are valid and high-minded statements as far as they go, but Relman was using them to defend the scientifically untenable position that medicine's use of RCCTs does in fact uniformly result in ̬̉objective quantitative evidencẻ̬ on which the medical treatment of individual patients can legitimately be based. What Relman and other physicians like him are doing in making unsound assertions like this is giving medical science a very bad name. They need to fully understand the following reminder by William James, which is called to mind in this connection:
"Our actions, and with them their consequences, actually change according to the beliefs which we have chosen." (̬̉Will To Believẻ̬).
Arnold Relman is defending his belief in the universal evidentiary validity of medicine's ̬̉gold standard̬̉ clinical trials. However, the RCCT usually will not qualify as science by any stretch of the human imagination. Instead, medicine's much-ballyhooed ̬̉gold standard̬̉ can most often be seen as a quest for certitude in medical judgments that is rooted in a belief system which often merely pretends to be scientific, objective, and impersonal. To the extent that everything has not been taken into consideration in a given trial, the fact is that that trial has little to do with valid scientific method. In that there is a very great deal that is simply not understood about the human organism, including those intricate fail-safe capacities of the body that are based upon layers of redundant molecular, cellular and humoral processes, it is almost impossible to determine all of the conditions that could affect outcomes for even one human subject, much less for the ̬̉averagẻ̬ subject in a supposedly randomized controlled trial. Recall what Dominique Lecourt has said of the living cell: ̬̉[W]e cannot help but marvel at the monitoring and self-correcting devices for detecting and rectifying errors and at the strategies -- and we might even say 'neat tricks'--that it uses for this purpose.̬̉ These complex ̬̉conditions̬̉ are part and parcel of every organism, and are inevitably ingredient in every clinical trial, yet they have been systematically--one might say chronically--omitted from consideration in most of the contemporary RCCT experiments.
Because RCCTs are invariably designed within a mechanistic/dualistic rather than an organismic framework, there is no way around the consequence that the formulation of an issue to be tested will usually be flawed; or that, given the shortcomings of a reductionistic and mechanistic mind-set, the collection of data through observation and experiment will also be seriously flawed. Under the sway of this well- entrenched but erroneous paradigm of medical experimentation, the predominance of what Sir James Black has termed a ̬̉mechanistic metaphor of biologỷ̬ places severe limits on the possibility of designing a truly scientific experiment or trial. Conventional medicine is therefore using the RCCT to once again force technology to the forefront; and, with the active assistance of giant pharmaceutical conglomerates and of many federal agencies, is aggressively marketing the results of RCCTs as if they bore a clear relationship to true scientific inquiry. The buyer certainly needs to be wary of RCCTs, for at least the following reasons:
- The conceptual basis of most RCCTs can be seen to be mechanistic, and not organismic. The two dominant notions that: a) a trial can isolate a specific chain of cause and effect; and, b) all relevant variables within the complex biochemical and biophysical factory that is the human organism can be or have been determined and controlled for; usually lack any basis in fact--yet these flawed notions continue to drive most of the rapidly proliferating experimental trials.
- The conceptual basis of most RCCTs can also be seen to be dualistic. The impact of a ̬̉placebỏ̬ group of subjects as representing an effective ̬̉control̬̉ simply misconstrues the actuality of the placebo effect. Christiane Northrup, MD has provided us with this trenchant observation about the human organism: ̬̉Thoughts and emotions can either create or destroy healthy tissue.̬̉ This concept would completely undermine any conclusive comparison between the outcomes for the ̬̉placebỏ̬ subjects and the experimental subjects in an RCCT. Therefore, in order to have a prayer of getting a marketable result from an RCCT, the human body has to be conceived of as being entirely separate from the mind and from the emotions.
Consider the comments of Ian R. McWhinney, MD on this latter point:
"Individual people have shown that they can alter their immune response both voluntarily and under hypnotic suggestion. The most plausible explanation of the beneficial effect of placebos--an anomaly within the mechanistic paradigm--is that it is a response of the organism to the symbolic meaning of a therapeutic relationship. There is abundant and growing scientific evidence, not only for the effect of relationships on health, but also for the physiological basis of these effects. The doctrine of specific etiology has been a dominant feature of the mechanistic paradigm, one cause being sought for each disease, based on the model of infectious diseases. ...In the organismic paradigm, etiology is viewed as a complex web of interacting causes, even when a proximal cause can provide the opportunity for therapeutic intervention. Rather than forces acting on a passive being, external agents may be triggers releasing processes that are already inherent in the person. The cause that precipitates an illness may be different from the causes that maintain it (i.e., the causes of chronicity, delayed healing, or death). This challenges the healer to identify the factors inhibiting healing and help the patient to strengthen and release his or her own healing powers." (Pew-Fetzer Task Force Report, pp.20-21)
On the assumption that the human organism is a machine, it would follow that clinical trials might be designed in which a specific, linear chain of causation could always be isolated, and in which all of the relevant variables within the ̬̉clockworks̬̉ could be known and controlled. However, once the concept of organism is given frank and full recognition, it becomes clear that the scientific basis of many RCCTs, and therefore the findings of such trials, would be exposed as unscientific. In her 1974 book ̬̉Kind and Usual Punishment: The Prison Business,̬̉ Jessica Mitford reported the fact that drug companies and university-based medical ̬̉centers of excellencẻ̬ were paying prisoners one dollar per day to participate in a variety of medical and drug testing protocols, many of which were life-threatening. This practice may still be going on in prisons, but probably at a higher wage level. Mitford was one of the first to take notice, about a quarter of a century ago, that only males were used in these experiments for the stated reason that the hormonal processes of premenopausal females were deemed to be so complicated and idiosyncratic as to render women prisoners unreliable subjects for these experiments. What Mitford did not point out at the time, probably because she was focused on the prison business and not on the medical business, was the fact that all of the medical/pharmaceutical miracles that emerged from the experimentation on this very captive audience were promptly prescribed for women patients, and usually with higher frequency than for male patients. Suddenly, and seemingly without a nanosecond of hesitation by physicians over the fact that the clinical trials of the specific pharmaceutical agents in question had excluded female subjects, medical concerns about the complex and idiosyncratic hormones of the female as a trial subject were dropped from practical consideration, and experimentally-sanctioned drug treatments were administered to female patients, willy-nilly.
How can this possibly be considered science? It would appear to be not only unscientific, but simply a fraud to exclude females from clinical trials on the basis that their complex hormonal activity would be likely to distort the results, and to then utilize drugs resulting from such trials as if they had a legitimate, scientifically established unisex applicability. Male-only pharmaceutical experiments could prove nothing with regard to females of the species, nothing at all. Yet the drugs flowing from such experiments are actively prescribed by physicians in the treatment of females. There has been a great deal of talk from the medical guild about the integrity of ̬̉gold standard,̬̉ double-blind clinical trials, yet in terms of actual medical practices resulting from these prisoner-based pharmacutical experiments, the snake-oil salesmen of yesteryear can be seen as a more honest bunch than the medical ̬̉scientists̬̉ who designed these particular clinical trials, or than those physicians who have acted clinically on the basis of the reported outcome of such experiments.
(continued...)
It shows explicitly why "the human body has to be conceived of as being entirely separate from the mind and from the emotions."
If a person who unconditionally believes the Scientific Method is unassailable reads this carefully, and lays aside personal feelings and convictions, this person will understand why it's not possible to always get unbiased trial results with something like the Bates Method using the current RCCTs (Randomized Controlled Clinical Trials). In fact, this article deals a cruel blow to the validity of the Scientific Method and its clinical trials as an appliance for every aspect of the complex human organism. In the sense that it works for some aspects and doesn't for others.
---------------------------------------------------
The fallacy of an assumption of simplicity 28 June 2003
Lawrence J. O,Brien,
retired health plan CEO
1200 N. nash Street #535,
Arlington, VA 22209 USA
The fallacy of an assumption of simplicity
Under the stimulus of a ridiculous idea like the ̬̉super pill̬̉ as a basis for adult humans to prevent disease and achieve health and long life, an Editorial like this in your highly respected Journal ought to first dissect what is really happening in contemporary medical experimentation. The conclusions of the meta-analysis that you cite are flawed because the clinical trials they are drawn from are fundamentally flawed. In an experiment conducted on the basis of classical scientific method the guiding presuppositions are that a specific cause is followed by a specific effect; that this effect can be predicted on the basis of an empirical understanding of its cause or causes; and that knowledge of the specific causation can be derived from knowledge of the effects. The fundamental error that calls into question conclusions being derived from an enormous number of randomized controlled clinical trials (RCCTs) being undertaken in the United States and elsewhere is that virtually every one of these medical experiments relies heavily on an ̬̉assumption of simplicity.̬̉ Any analysis of human organisms that depends upon an assumption of simplicity can lead to none other than erroneous conclusions, because these organisms--quite apart from their fundamental idiosyncrasy--have evolved as one of the most complex living systems to be found in Nature. As soon as an assumption of simplicity enters into a clinical trial or other experiment that involves human bodies, any claim that the trial or experiment is scientific becomes fraudulent. Simply put, it is impossible to hold that a study of human organisms can have anything at all to do with a notion that these organisms are simple. Thinking that human organisms can be meaningfully studied on the basis of an assumption that they are simple would represent a high point in intellectual bankruptcy. Most unfortunately, conventional medicine in the United States has not understood this very plain matter of fact. As a result, clinical trials and other medical experiments that are demonstrably rooted in a flawed idea--the assumption of simplicity--are being launched at a furious pace. The victims of this folly on the part of the medical profession would be difficult to quantify with accuracy, however the entire population is placed at risk through this radical and foolhardy burst of experimentation, most of it paid for with taxpayer funds.
The requirements of the scientific method have been traditionally defined as: ̬̉[P]rinciples and procedures for the systematic pursuit of knowledge involving the recognition and formulation of a problem, the collection of data through observation and experiment, and the formulation and testing of hypotheses.̬̉ (Merriam-Webster's tenth edition). The ability to precisely replicate an experiment on demand is an essential element of the scientific method.
In the face of the inescapable fact of overwhelming organismic complexity, biological science must proceed to make matters intelligible by describing what the structures and processes of an organism are, and how an organism does what it does. The scientist must begin by making certain that everything has been taken into consideration, and that nothing has been omitted from consideration. In classical scientific method, a theory or generalization is formed from empirically observed facts that are derived by the use of inductive and deductive reasoning; next, consistent connection must be demonstrated between and among the assembled facts, as well as with a body of systematic generalizations derived from other facts already accumulated and verified. Then, both the empirical and the logical implications and consequences that these ̬̉new̬̉ facts may have for the pre-existing body of systematic generalizations must be drawn out in specific terms; the ̬̉new̬̉ facts and any ̬̉new̬̉ generalizations must then be systematically and empirically verified and justified; and, finally, it must be shown that all of the ̬̉new̬̉ facts can be deduced, quantified, predicted, and replicated on the basis of the extant systematic body of generalizations.
The American philosopher and educator John Dewey once observed that the greatest and most pervasive fallacy of human thinking is the neglect of context. Medicine's methodologies in the design and conduct of its ̬̉gold standard̬̉ clinical trials constitute a striking example of this fallacy at work. Technological medicine's first mistake has been its misperception of the ̬̉problem̬̉ about which knowledge is being systematically pursued. Its dominant and entirely erroneous conception of the human organism--the subject and the object of all medical inquiry--is that it is most like a clockwork, a machine. Although this remains in place as American medicine's most controlling and unquestioned paradigm, the concepts of clockworks or machines as useful analogies for the human organism can be seen to be entirely inappropriate as the basis for describing what the structures and processes of an organism are, and demonstrating how an organism does what it does. By its reliance on the assumption of simplicity, twentieth century technological medicine has most certainly neglected the context within which any legitimate inquiry involving the human organism must take place.
Today, many physicians believe that the double-blind study rises to the level of a ̬̉gold standard̬̉ because it results in ̬̉objective, evidence-based proof̬̉ on the basis of which subsequent medical practices may rationally be defended. However, since the object of medical inquiry is the human organism in all of its complexity and idiosyncrasy; and since there is no alternative to the admission that far more is unknown than is known about the inner workings of human organisms; it is plainly an unproven belief to hold that all RCCTs result in knowledge about the treatment of human organisms that is so ̬̉completely determined by the objective evidencẻ̬ as to thereby be rendered certain and unassailable.
The fact that the science of medicine must be accepted as being a science of complexity, because its subject matter is the human organism, does not mean that it will never be possible to experimentally isolate a specific chain of causality to explain or to treat some abnormality of the human body. As complex and idiosyncratic as medicine's basic subject matter is, there are some instances in which cause and cure turn out to be related one-to-one. But it does mean that, in human experimentation, we must expect specific etiologies of this variety to be very rare occurrences, very much the exception and not the rule. To qualify as science, the study of human organisms must always be rooted in the recognition of the fittingness of Nobel Laureate Sir James Black's conclusion that, in studying human organisms, ̬̉we have entered the world of quantum theory, in which the whole is enfolded into each part and each part is enfolded into the whole, as in a hologram.̬̉ Whenever the specific subject matter of an RCCT is inherently more complex than a theory of specific causality could scientifically cope with, which will most often be the case in a clinical trial involving human organisms, it would thereby be demonstrable that no outcome of the trial could possibly be justified as representing ̬̉the full collection of impersonal and objectivẻ̬ quantitative evidence, but would instead be a result of an unsubstantiated personal belief by the investigators in the completeness of their experiment. This means that, except for those rare exceptions when a ̬̉specific etiologỷ̬ basis for a trial can be conclusively demonstrated to be scientifically valid, the ̬̉gold standard̬̉ clinical trials in use by conventional medicine today are based principally on the subjective and often biased beliefs of the designers of the particular RCCT--that is, on acts of faith by investigators that cannot possibly qualify as scientific evidence. For those who study medicine's subject matter from an organismic point of view, then, the ̬̉gold standard̬̉ proofs claimed to be issuing from the plethora of RCCTs being conducted today can rarely be accepted as being based upon ̬̉the full collection of impersonal and objective evidence,̬̉ as leaders of the American medical guild such as Arnold S. Relman, MD would have us believe. In a public forum held in Arizona during April 1999, Relman said the following:
"Medical science teaches practitioners to look for objective evidence before adopting a clinical method. ...All clinical biases and preconceptions, whether in alternative or conventional medical practice, must fall before the objective evidence, and we should be assiduous in seeking such evidence to improve our practices. ...At the least, [physicians] owe their patients their best professional advice, based on the most reliable information."
These are valid and high-minded statements as far as they go, but Relman was using them to defend the scientifically untenable position that medicine's use of RCCTs does in fact uniformly result in ̬̉objective quantitative evidencẻ̬ on which the medical treatment of individual patients can legitimately be based. What Relman and other physicians like him are doing in making unsound assertions like this is giving medical science a very bad name. They need to fully understand the following reminder by William James, which is called to mind in this connection:
"Our actions, and with them their consequences, actually change according to the beliefs which we have chosen." (̬̉Will To Believẻ̬).
Arnold Relman is defending his belief in the universal evidentiary validity of medicine's ̬̉gold standard̬̉ clinical trials. However, the RCCT usually will not qualify as science by any stretch of the human imagination. Instead, medicine's much-ballyhooed ̬̉gold standard̬̉ can most often be seen as a quest for certitude in medical judgments that is rooted in a belief system which often merely pretends to be scientific, objective, and impersonal. To the extent that everything has not been taken into consideration in a given trial, the fact is that that trial has little to do with valid scientific method. In that there is a very great deal that is simply not understood about the human organism, including those intricate fail-safe capacities of the body that are based upon layers of redundant molecular, cellular and humoral processes, it is almost impossible to determine all of the conditions that could affect outcomes for even one human subject, much less for the ̬̉averagẻ̬ subject in a supposedly randomized controlled trial. Recall what Dominique Lecourt has said of the living cell: ̬̉[W]e cannot help but marvel at the monitoring and self-correcting devices for detecting and rectifying errors and at the strategies -- and we might even say 'neat tricks'--that it uses for this purpose.̬̉ These complex ̬̉conditions̬̉ are part and parcel of every organism, and are inevitably ingredient in every clinical trial, yet they have been systematically--one might say chronically--omitted from consideration in most of the contemporary RCCT experiments.
Because RCCTs are invariably designed within a mechanistic/dualistic rather than an organismic framework, there is no way around the consequence that the formulation of an issue to be tested will usually be flawed; or that, given the shortcomings of a reductionistic and mechanistic mind-set, the collection of data through observation and experiment will also be seriously flawed. Under the sway of this well- entrenched but erroneous paradigm of medical experimentation, the predominance of what Sir James Black has termed a ̬̉mechanistic metaphor of biologỷ̬ places severe limits on the possibility of designing a truly scientific experiment or trial. Conventional medicine is therefore using the RCCT to once again force technology to the forefront; and, with the active assistance of giant pharmaceutical conglomerates and of many federal agencies, is aggressively marketing the results of RCCTs as if they bore a clear relationship to true scientific inquiry. The buyer certainly needs to be wary of RCCTs, for at least the following reasons:
- The conceptual basis of most RCCTs can be seen to be mechanistic, and not organismic. The two dominant notions that: a) a trial can isolate a specific chain of cause and effect; and, b) all relevant variables within the complex biochemical and biophysical factory that is the human organism can be or have been determined and controlled for; usually lack any basis in fact--yet these flawed notions continue to drive most of the rapidly proliferating experimental trials.
- The conceptual basis of most RCCTs can also be seen to be dualistic. The impact of a ̬̉placebỏ̬ group of subjects as representing an effective ̬̉control̬̉ simply misconstrues the actuality of the placebo effect. Christiane Northrup, MD has provided us with this trenchant observation about the human organism: ̬̉Thoughts and emotions can either create or destroy healthy tissue.̬̉ This concept would completely undermine any conclusive comparison between the outcomes for the ̬̉placebỏ̬ subjects and the experimental subjects in an RCCT. Therefore, in order to have a prayer of getting a marketable result from an RCCT, the human body has to be conceived of as being entirely separate from the mind and from the emotions.
Consider the comments of Ian R. McWhinney, MD on this latter point:
"Individual people have shown that they can alter their immune response both voluntarily and under hypnotic suggestion. The most plausible explanation of the beneficial effect of placebos--an anomaly within the mechanistic paradigm--is that it is a response of the organism to the symbolic meaning of a therapeutic relationship. There is abundant and growing scientific evidence, not only for the effect of relationships on health, but also for the physiological basis of these effects. The doctrine of specific etiology has been a dominant feature of the mechanistic paradigm, one cause being sought for each disease, based on the model of infectious diseases. ...In the organismic paradigm, etiology is viewed as a complex web of interacting causes, even when a proximal cause can provide the opportunity for therapeutic intervention. Rather than forces acting on a passive being, external agents may be triggers releasing processes that are already inherent in the person. The cause that precipitates an illness may be different from the causes that maintain it (i.e., the causes of chronicity, delayed healing, or death). This challenges the healer to identify the factors inhibiting healing and help the patient to strengthen and release his or her own healing powers." (Pew-Fetzer Task Force Report, pp.20-21)
On the assumption that the human organism is a machine, it would follow that clinical trials might be designed in which a specific, linear chain of causation could always be isolated, and in which all of the relevant variables within the ̬̉clockworks̬̉ could be known and controlled. However, once the concept of organism is given frank and full recognition, it becomes clear that the scientific basis of many RCCTs, and therefore the findings of such trials, would be exposed as unscientific. In her 1974 book ̬̉Kind and Usual Punishment: The Prison Business,̬̉ Jessica Mitford reported the fact that drug companies and university-based medical ̬̉centers of excellencẻ̬ were paying prisoners one dollar per day to participate in a variety of medical and drug testing protocols, many of which were life-threatening. This practice may still be going on in prisons, but probably at a higher wage level. Mitford was one of the first to take notice, about a quarter of a century ago, that only males were used in these experiments for the stated reason that the hormonal processes of premenopausal females were deemed to be so complicated and idiosyncratic as to render women prisoners unreliable subjects for these experiments. What Mitford did not point out at the time, probably because she was focused on the prison business and not on the medical business, was the fact that all of the medical/pharmaceutical miracles that emerged from the experimentation on this very captive audience were promptly prescribed for women patients, and usually with higher frequency than for male patients. Suddenly, and seemingly without a nanosecond of hesitation by physicians over the fact that the clinical trials of the specific pharmaceutical agents in question had excluded female subjects, medical concerns about the complex and idiosyncratic hormones of the female as a trial subject were dropped from practical consideration, and experimentally-sanctioned drug treatments were administered to female patients, willy-nilly.
How can this possibly be considered science? It would appear to be not only unscientific, but simply a fraud to exclude females from clinical trials on the basis that their complex hormonal activity would be likely to distort the results, and to then utilize drugs resulting from such trials as if they had a legitimate, scientifically established unisex applicability. Male-only pharmaceutical experiments could prove nothing with regard to females of the species, nothing at all. Yet the drugs flowing from such experiments are actively prescribed by physicians in the treatment of females. There has been a great deal of talk from the medical guild about the integrity of ̬̉gold standard,̬̉ double-blind clinical trials, yet in terms of actual medical practices resulting from these prisoner-based pharmacutical experiments, the snake-oil salesmen of yesteryear can be seen as a more honest bunch than the medical ̬̉scientists̬̉ who designed these particular clinical trials, or than those physicians who have acted clinically on the basis of the reported outcome of such experiments.
(continued...)