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Medical Bias, Anti - nutrition Bias, and Clinical Trials

 
 

Quick Guide

Medical bias and clinical trials, including anti-nutrition bias and publication bias and their effect upon alternative therapies and the publication of negative trial results. Find out also about conflicts of interest and the causes of  medical bias and possible ways in which they may be overcome.

 
 


To access the following subsections, click on the subtitle or scroll through the article.

Medical Bias against Nutrition and Alternative Therapies

Other Forms of Medical Bias

The Significance of Medical Bias

Conflicts of Interest and Causes of Medical Bias

Clinical Trials, Clinical Trials, and more Clinical Trials

Overcoming Medical Bias

Links and References

1. Types of Medical Bias

a) Medical Bias against Nutrition and Alternative Therapies

For the past 200 - 300 years of reductionist science, nutritional therapy has been relegated to the realms of quackery by so called scientific medicine ( see Science Today, Quackery Tomorrow). While logic would dictate that the starting point for any meaningful study of health and disease should concern first and foremost those fundamental building blocks of which we are all comprised ( see Nutrition is for the Birds ), to the scientist, the therapeutic use of toxic foreign compounds has traditionally been considered much more preferable. Even when such toxic compounds were known to cause numerous deaths and suffering, they were generally preferred to more harmless nutritional or other alternative treatments. This attitude represents an illogical, unscientific and obsessive bias or resistance to the use of nutritional therapies ( 1, 2, 3, 4 ), an attitude which was supported and perpetuated by persecution or deregistration of medical practitioners who dared to use nutritional or alternative therapies ( 1, 2, 5, 6, 7, 8 ). According to Jonas ( 24 ) in this regard:

"Historically, orthodox medicine fights these practices vigorously by denouncing and attacking them, restricting access to them, labelling them as antiscientific and quackery, and imposing penalties for practicing them. When these therapies persist and even rise in popularity despite this, mainstream medicine then turns more friendly, examining them, identifying similarities they have with the orthodox, and incorporating or integrating them into the routine practice of medicine."

The decision to relegate nutritional therapy to the realms of quackery more than 200 years ago ( see Science Today, Quackery Tomorrow ) has had dire consequences, the discovery and effective treatment of nutritional diseases ( see Nutrition is for the Birds ) being unnecessarily obstructed and delayed. It seems that medical authorities could not accept the fact that disease may have a negative causality rather than a positive one ( 1 ). Even today orthodox medicine prefers not to accept evidence that nutritional deficiencies may cause various illnesses ( see Nutrition is for the Birds; B Vitamins page ), a fact which further underlines the serious and ongoing nature of this problem. Traditionally, the promotion and implementation of nutritional therapies has generally been performed by non-medical disciplines or lay persons, while the medical profession has commonly sought to discourage this process.

It should be noted that although orthodox medicine initially rejected nutrition as an alternative therapy or quackery ( 10 ), in more recent times the publicising of nutritional discoveries by non-medical practitioners has apparently proven to be a source of irritation to the medical community ( 1, 25 ). Apparently those within the medical profession are "biased" against "outsiders" making "therapeutic suggestions" ( 25 ). For doctors it seems, the important point has been whether nutritional discoveries are made by outsiders, rather than whether or not they are effective and are supported by scientific evidence. Now however, as has been noted by Dalen ( 25 ), doctors can no longer afford to wear "blinders" ( 25 ) and automatically reject therapies proposed by those outside of mainstream medicine.

Since for the past 200 years the medical profession has generally refused to acknowledge the fact that nutritional treatment had any "therapeutic" potential whatsoever, regarding such therapies as quackery and even seeking to persecute those who promoted alternative therapies ( 24 ), it is indeed difficult to understand how the claim can now be made that the the use of alternative therapies was rejected simply because the claims were made by "outsiders". One may well ask why it was left to outsiders to make these claims and why both scientific evidence and common sense have been continually rejected by orthodox medicine.

Since anti-nutrition bias has had such a profound effect in shaping the direction of medical science over the past 200 - 300 years, it is imperative that we understand the nature and origin of this bias and the ways in which we may overcome it.

According to Goodwin and Tangum in their classic study ( 1 ), anti-nutrition bias is characterised by three identifying features. Firstly, those who adopt a biased attitude against nutrition generally display an "uncritical acceptance" ( 1 ) of any allegations regarding the toxicity of nutritional supplements. To illustrate this point, Goodwin and Tangum cite various medical claims that high doses of vitamin C may cause kidney stones. When the basis of these claims was examined by Goodwin and Tangum however, they found that there was no supporting evidence to substantiate them. Goodwin and Tangum note that such unfounded claims of vitamin toxicity represent a "major component of medical writing on vitamin supplements" ( 1 ). When it comes to allegations concerning the toxicity of alternative therapies, it seems that any rumour will be readily embraced by orthodox medicine ( 70 ).

The second distinguishing feature of anti-nutrition bias relates to the "angry", "scornful", and "dismissive" tone such persons use when discussing the use of nutritional supplements and alternative therapies ( 1, 3 ). To illustrate this point Goodwin and Tangum ( 1 ) refer to the language used to describe nutritional therapies in the various editions of the two classical medical textbooks, Harrison's Principles of Internal Medicine, and the Cecil Textbook of Medicine. Goodwin and Tangum ( 1 ) note that this scornful dismissive language is not used when other controversial topics of medicine are discussed. It would indeed be interesting to determine precisely why doctors feel that it is necessary to reserve this type of language for the discussion of nutrition.

The third means by which persons who are biased against nutrition may be identified is by their refusal to acknowledge evidence of the clinical effectiveness of nutritional supplements ( 1, 2, 4 ). Many doctors it seems, refuse to even consider the results of nutritional research ( 2 ) and react as if they are being "personally attacked" ( 2 ) when they are informed of the benefits of alternative therapies. In this instance, Goodwin and Tangum ( 1 ) cite the medical profession's refusal to acknowledge evidence of the effectiveness of vitamin E treatment of intermittent claudication, although there are numerous other examples as I have mentioned elsewhere (see, But What about Efficacy?; Nutrition is for the Birds; and B Vitamins ). Although Goodwin and Tangum ( 1 ) cite various trials indicating that vitamin E treatment of intermittent claudication was at least as effective as the accepted medical treatment, namely the use of vasodilators, vitamin E treatment nevertheless was not mentioned in the major medical textbooks ( 1 ). Modern medicine it seems, requires considerably more evidence to justify the use of alternative therapies than is required for the use of traditional medical therapies ( 9 ). This type of medical bias also effects herbal treatments such as St John's Wort, trials of which are often unduly criticised ( 45 ).

The precise reasons why this anti-nutrition bias has such a long history, and continues to be so prevalent today, are not generally agreed. The suggestion that medicine could not accept the concept of the "negative causality" of disease ( 1 ) not only defies logic, it implies a level of naivety amongst the medical profession which would be completely unacceptable. After all, exclusive belief in the positive causality of disease requires that we believe that illness could not possibly result from nutritional deficiencies caused by malnutrition or starvation, hardly an acceptable premise. The possibility that anti-nutrition bias may be explained by the reduced profitability of therapeutic nutrition as compared to drug therapy is obviously very relevant today, however, it hardly seems likely that this was a significant factor 200 years ago when nutrition was first relegated to the realms of quackery ( 10 ).

It is entirely inappropriate to consider the cause of anti-nutrition bias without also considering the underlying philosophical environment which enabled this type of healing system to foster. Drug oriented orthodox medicine is of course, a product of scientific reductionism and interventionism ( see Holistic or Reductionist? ) and it is this fact, perhaps more than any other, which has been responsible for the rejection of nutrition as quackery. Nutritional therapy, being fundamentally holistic in nature, is inconsistent with reductionism and interventionism. It is difficult indeed to envisage nutritional therapies becoming predominant in a reductionist interventionist environment, a fact which would appear to be borne out by the observation that the promotion or utilisation of nutritional therapies was generally left to outsiders. 

Undoubtedly there has also been a degree of intellectual elitism involved here ( 1 ) as followers of the new reductionist science sought to distance themselves from other sections of the community. Elitism of course, has as its aim the maintenance of social and intellectual status and not the pursuit of science or truth. Hunger for truth, the first casualty of bias, is a by-product of humility, not elitism.

b) Other Forms of Medical Bias

Probably the best known form of medical bias is publication bias, the refusal to publish or submit for publishing, negative or unfavourable trial results ( 11,12,13, 14, 15, 16, 17, 67 ). Publication bias, whether the result of the refusal of researchers to submit to journals or the refusal of journal editors to publish submitted articles, may cause a significant overestimation of the effectiveness of the trialled treatment or drug ( 26 ). Clinical trials which show significant positive results are 9 times more likely to be published in medical journals than are trials which fail to produce such positive results ( 13 ). Even in the popular media, in newspapers, there is also a bias against the publication of negative medical studies (16, 18 ). Medical press releases in the popular media tend to show a significant bias with desired drug effects being exaggerated while study limitations and conflicts of interest are frequently not mentioned ( 63, 64 ). Almost 80% of all medical press releases failed to mention the fact that the studies concerned were industry funded ( 63, 64 ).

Interestingly, publication bias may also involve a language bias with some authors who publish in two languages such as German and English, tending to publish unfavourable results in German and the positive findings in English ( 26, 67 ). There may also be what has been termed "time lag bias" when the "speed of publication depends upon the direction and strength of the trial results" ( 67 ). Negative trial results, if published at all, may take twice as long to publish as positive results ( 67 ). As has been pointed out by Jadad and Rennie ( 67 ), "....if trials with positive results are published years faster than those with negative results, new interventions will be accepted as effective in the absence of evidence to the contrary, although that evidence may already have been gathered."

Publication bias is however, only part of the problem. Drug companies which fund research, may also influence the outcome of research at any level of the research process. Amazingly, authors of studies appearing in medical journals may, in reality, have had very little to do with the research with which they are credited.  According to Smith in this regard ( 28 ): "we editors of medical journals worry that we sometimes publish studies where the declared authors have not participated in the design of the study, had no access to the raw data, and had little to do with the interpretation of the data. Instead the sponsors of the study - often pharmaceutical companies - have designed the study and analysed and interpreted the data. Readers and editors are thus being deceived."

If this is not bad enough, drug companies may also refuse to fund any study which would compare the effectiveness of drug therapies with alternative or non-drug treatments just in case the alternative treatment is shown to be more effective ( 16 ). In fact, research proposals which are of vital scientific importance may be rejected in favour of more potentially profitable research because of the difficulty in obtaining funding ( 35 ). According to Angell ( 35 ), this could mean "more research on drugs and devices and less designed to gain insights into the causes and mechanisms of disease." Angell continues: "it would also skew research toward finding trivial differences between drugs, because those differences can be exploited by marketing."  In other words it seems, medicine as it is currently structured is biased against the discovery of disease causation. It is symptom based and not cause based, a point that I have made elsewhere ( see Orthodox Medicine; Medical Evidence or Medical Ignorance? ).

Drug companies then, decide the nature of the research studies that will be funded ( 16, 35 ), they then design the study ( 28, 32 ), analyse and interpret the data ( 28, 32 ), and then "bury" the results if they are deemed to be unfavourable for the purposes of promoting the company's products ( 32 ).

In view of the extremely serious nature of these problems it is clear that urgent action is required, and it is indeed commendable to see some medical journals beginning to make improvements in this regard ( 19, 20, 28, 29, 30, 31, 32 ). Resistance to the elimination of medical bias however, is bound to occur. It is for instance, disturbing to see prominent academic institutions, such as Harvard University and medical journals such as the New England Journal of Medicine, reducing safeguards so as to increase the potential for drug companies to influence research results ( 21, 35, 62, 65 ). Drug companies may also attempt to prevent publication of unfavourable medical trials or reports ( 37, 38, 40, 41, 42, 43 ). When the editors of prominent medical journals express their concerns about medical bias and note the need for reforms, it is most disturbing to see other authorities, such as Dr Bert Spilker, the senior vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers Association of America, describe these concerns as "patently absurd" ( 30 ). To the credit of Dr Spilker however, one month later he apparently acknowledged the need for reforms ( 30, 36 ). 

The introduction of evidence based medicine has created new problems in eliminating medical bias. Since evidence based medicine is not based upon the results of single studies published in medical journals, but rather the development of prescribing guidelines from review articles, it is clear that the current proposals will be ineffective in the world of evidence based medicine. Review articles, which may be based upon research conducted many years earlier, may selectively quote the literature and may therefore be biased in favour of the perspective of the reviewer ( 33, 34; see also the B vitamin page ). This type of bias of course, continues to be of concern even if the separate reviewed studies themselves are completely unbiased. It is abundantly clear that the preparation of prescribing guidelines and medical reviews offers unique opportunities to improperly influence the outcome of medical research. For more information about evidence based medicine, click here.

In the final analysis the accuracy and reliability of medical research is claimed to be safeguarded by the much heralded "peer review" process. However, recent studies have failed ( 66 ) " to show any dramatic effect, let alone improvement, brought about by editorial peer review." In fact, it seems that there is little scientific evidence to support the peer review process ( 66 ). According to Rennie ( 66 ), "if the entire peer-review system did not exist but were now to be proposed as a new invention, it would be hard to convince editors looking at the evidence to go through the trouble and expense." Since so many "peers" have conflicts of interest and continue to contribute to various forms of medical bias, the failure of the peer review system is hardly surprising.

2. The Significance of Medical Bias

Since it would seem that the main purpose of bias is to deceive, or conceal the truth, and, in so doing, to maximise profits and perhaps determine the direction of medical progress, it is hardly surprising that bias has had terrible consequences. Although the consequences of bias are frequently insidious and evolutionary, on some occasions bias has resulted in dramatic and tragic consequences. Recently for instance, the refusal to publish negative trial results for the heart drug lorcainide resulted in up to 70,000 deaths annually in the United States alone ( 6, 17, 22 ). Such tragic consequences, unparalleled in the world of alternative medicine, maximise the incentives for honesty in publication of medical research and the adoption of more harmless "treatments".

When it comes to anti-nutrition bias there have also been dire consequences. It is tragic for instance, to witness the reluctance of the medical profession to initially accept the nutritional basis of the classical deficiency diseases pellagra and beri beri. Having apparently learned nothing from this terrible mistake of medical history, it is even more tragic to see doctors refusing to accept the ill effects of folic acid deficiency during pregnancy until about 30 years after these ill effects were first discovered ( see Nutrition is for the Birds ). Translated into human terms, this is a terrible price to pay for bias.

Even more tragic however, is the ongoing refusal of the medical profession to acknowledge the vital part played by nutrition in numerous "incurable" diseases of modern society. In spite of the fact that there is a considerable amount of evidence confirming the effectiveness of nutritional supplements in the treatment of diseases such as asthma, heart disease, diabetes, schizophrenia, and depression, this evidence continues to be rejected by the medical profession at large, usually in favour of toxic drug therapies ( see, But What About Efficacy?; Nutrition is for the Birds; B Vitamins ). It is abundantly clear that the bias against nutrition continues to be a major impediment to future medical progress.

Anti-nutrition bias is not just a problem in medical research however, it is a significant problem across all areas of the medical profession. From medical training, where a pronounced anti-nutrition curricular bias ensures medical students learn little of this vital subject, right through to clinicians and general practitioners who rarely prescribe nutritional treatments, anti-nutrition bias is endemic. Even in hospitals we have seen the occurrence of so called iatrogenic malnutrition because doctors did not believe nutrition was necessary for the recovery of their patients ( see Nutrition is for the Birds ). Patients whose symptoms are due to nutritional deficiencies, or whose condition may be considerably improved by the correct use of nutritional supplements, are most unlikely to receive appropriate treatment from a conventional medical practitioner, unless of course the practitioner concerned has also been trained in naturopathy or holistic medicine.

Medical bias, regardless of type, represents an abandonment of scientific impartiality. The prevalence of bias in the medical world is an indicator of the priority scientists and medical professionals give to truth and scientific facts. In essence, since the need for bias is rooted in a desire to deceive or mislead, irrespective of either the scientific facts or the consequences, the prevalence of bias is a means by which the alleged scientific basis of medicine may be readily assessed. Furthermore, the energy and determination with which scientists and medical authorities seek to eliminate bias from the scientific world is a clear indicator of their commitment to honesty and scientific impartiality. It is extremely disturbing to note that the "leaders of the medical profession" ( 15 ) are only "minimally concerned" ( 15 ) about the poor quality of much medical research, a matter which requires our most urgent attention, attention which should be proportional to our concern about public health ( see Medical Evidence or Medical Ignorance for more about the poor quality of medical research ).

3. Conflicts of Interest and Causes of Medical Bias

Bias is commonly caused by the desire to maximise profits, enhance one's reputation and career prospects, or attract funding for further research. Bias is the result of researchers, medical colleges, drug companies, and other vested interests, establishing an environment wherein professional self interest and profit are regarded as being more important than integrity and public health. Medical bias is encouraged by the increasingly close financial connections between academia and industry, some of which are listed below ( 35, 39 ).

  • Medical research is funded by drug companies.
  • Medical colleges and medical associations funded by drug companies.
  • Drug companies use gifts to influence doctors and hospitals.
  • Medical researchers and journal editors frequently have financial ties or shares with drug companies.
  • Partnerships between academic institutions and drug companies.
  • Researchers agree to be credited for articles prepared by drug companies.

Opportunities to improperly influence medical research and practice are clearly increasing in spite of the introduction of more stringent acceptance criteria by some medical journals.  In fact, so prevalent are these conflicts of interest within the medical community that it is difficult to find editorial writers who do not have financial ties to drug companies or other medical manufacturers ( 35 ). Not surprisingly, research studies funded by drug companies are more likely to support drug therapies rather than alternative or non-drug therapies ( 44 ).

Two particularly disturbing practices are the "ghostwriting" of medical articles by drug companies or other vested interests ( 28, 35 ), and the use of gifts and inducements by drug companies in an effort to control the prescribing behaviour of doctors ( 35, 39 ). Since "promotional dinners" may result in an "80% increase in the sales of the promoted drug" ( 44 ), the effect of these types of inducements should not be underestimated. Even more disturbing is the fact that a doctor's knowledge about drugs may be determined, apparently unbeknown to the doctor, more by "deceptive advertisements" rather than "scientific reports" ( 44 ). It is clear that drug industry propaganda has a considerable influence upon both the knowledge and prescribing habits of doctors, a matter which is of considerable concern.

It is not only the drug companies however who seek to mislead consumers and prevent them from being correctly informed about pharmaceutical products. Recently it has been reported that tobacco companies have sought to prevent dissemination of educational and promotional material accompanying the anti-smoking treatment "Nicorette" ( 68, 69 ). According to Shamasunder and Bero ( 68 ), not only did tobacco companies also restrict "to whom the pharmaceutical company could market its transdermal nicotine patch", but furthermore, "subsidiary tobacco and pharmaceutical companies of a parent company collaborated in the production of a nicotine-release gum." This interference in marketing of pharmaceutical products was bought about by "well-hidden financial ties between pharmaceutical and tobacco companies" ( 68 ).

4. Clinical Trials, Clinical Trials, and more Clinical Trials

Clinical trials it seems, are rapidly becoming the backbone or "gold standard" ( 55 ) of evidence based medicine. In fact, the use of clinical trials in Australia has increased 20 fold in 10 years ( 46, 47 ), a fact which, given the drug industry funding of most trials, increasingly gives the impression that "clinical investigators" are merely "agents of" ( 48 ), and doctors are being "bought" by ( 49 ), the pharmaceutical industry. Not only are most research studies and clinical trials funded by pharmaceutical companies, but further, they may also be analysed and "ghostwritten" by these same companies. Not surprisingly, "in many cases the industry sponsored trial doesn't have a valid scientific intention" ( 48 ). Although, as is pointed out by Jenkins ( 49 ), some trials receive government funding, Jenkins also notes that government funding is "exceptionally difficult" to obtain ( 49 ).

For clinical trials to serve as a basis for evidence based medicine they clearly need to become more scientific and reliable and less profit motivated. The problems associated with the use of clinical trials, some of which I have already considered, are listed below.

  • Profit driven - a marketing tool
  • By deciding which studies to fund, pharmaceutical companies may determine the nature and direction of medical research.
  • Biased against alternative therapies - see below. 
  • Huge prohibitive cost of trials favours large drug companies.
  • Ability of  pharmaceutical companies to covertly analyse and prepare reports and prevent or delay publication of unfavourable reports, makes the results scientifically useless.
  • Frequent conflicts of interest between researchers and drug companies makes scientific honesty and impartiality virtually impossible.

Opportunities to improperly influence the outcome or publication of clinical trials are it seems, almost unlimited. Recently for instance, trials of a new anti-fungal drug were biased in favour of the new drug by comparing it with other drugs which were used inappropriately. The new drug, fluconazole, was compared with Amphotericin B and nystatin. The problem was however, that Amphotericin B was given to most patients orally when this drug was known to be poorly absorbed and therefore would be ineffective for the treatment of systemic fungal infections when administered by this route ( 27, 50, 51 ). Nystatin, the other drug with which fluconazole was being compared, was also known to be ineffective for the treatment of systemic fungal infections for which, in this case, it was being used ( 27, 50, 51 ). The problems encountered during these studies, many of which were funded by the manufacturer of the new drug ( 50 ), "seemed to commercially benefit the sponsor of these studies" ( 27 ).

The most astonishing thing about these studies is that medical researchers apparently agreed to participate in such fundamentally flawed studies and supposedly scientific medical journals agreed to publish the results. Further compounding the problem, attempts to obtain additional background information from the authors of these studies which might explain these problems, were unsuccessful.

An additional related problem here, especially with the emergence of so called "evidence based medicine", is the deliberate "skewing" of meta-analysis results by covert duplication of studies or repeated inclusion of the same patients or trial participants ( 27, 51 ). This duplication of trials is concealed by failure to mention the data had been published elsewhere, by citing different authors on each occasion the research is published, or by covertly including the same patients or trial participants in different studies ( 27, 51 ). For instance, 20 double blind trials were found, after much painstaking research, to represent just "7 small trials and 2 large trials" ( 27 ). In another series of studies 17% of the trials were duplicates and 28% of the patients were reported twice leading to a 23% overestimation of the efficacy of the drug being trialled ( 27 ). Not only is it astonishing that the outcome of meta-analysis results can be manipulated in such an unscrupulous fashion, but further, the general silence of the medical profession about this matter suggests that it is generally accepted. As has been noted by Jadad and Rennie ( 67 ), randomised controlled trials "can be vulnerable to multiple types of bias at all stages of their life spans."

As a patient, I am also alarmed about the fact that the recruitment of trial participants by doctors and hospitals is apparently becoming a lucrative business ( 47, 52, 53 ), in some cases, doctors or hospitals being paid $10,000 per patient ( 52, 53 ). Although it costs around $US500 million to bring a new drug to market ( 52 ), and $100,000 of this may go to the doctor or hospital that recruits the participants in the trial ( 52 ), the patients themselves may be unaware of these facts ( 52 ). Patients it seems, are being "bought and sold like commodities by doctors and pharmaceutical companies" ( 46 ). Even worse, although ethical approval for such trials may initially be difficult to obtain ( 52 ), this may be overcome by doctors establishing their own ethics committee which may consist of the doctor's "sister, his rabbi, his former lawyer and his former patient" ( 46, 52 ). 

The most despicable aspect of all this however, is the exploitation of intellectually disabled persons, who are unable to give their own consent, for participation in drug trials ( 46, 52, 54 ). Exploitation of the handicapped in this way is a scandal, a scandal which is made even worse by the participation of the New South Wales Guardianship Tribunal ( 46, 52, 54 ). The Tribunal is entrusted with the care and protection of those members of society who are incapable of looking after themselves and making their own decisions. Exploitation of institutionalised Guardianship Board patients for drug trials is a shameful abuse of the trust and legislative power which this body possesses. Quite apart from the moral question however, there must surely be a huge question mark about the scientific relevance of such studies for patients in the wider community.

As far as alternative medicine is concerned, the implications of establishing a health care system which has a fundamental dependence upon the use of clinical trials seems to be widely unrecognised ( see also discussion about evidence based medicine ). Listed below are various reasons why alternative medicine is significantly disadvantaged by excessive reliance upon clinical trials.

  • Prohibitive cost favours large drug companies and patentable medicines.
  • Promotes a reductionist symptomatic perspective which favours quick acting interventionist treatments and symptom suppressing drugs - slower natural cause based therapies may be deemed ineffective by comparison.
  • Traditional holistic therapies which have been tested by millions of people over hundreds or thousands of years are disadvantaged by very brief selective trials.
  • Clinical trials are outcome based rather than cause based - they favour treatment of disease symptoms rather than prevention, which is one of the traditional strengths of holistic medicine.
  • Individualised nature of many alternative therapies is not conducive to testing by clinical trials.
  • Clinical trials focus upon disease rather than health.

For the above reasons excessive reliance upon clinical trials is fundamentally inconsistent with the requirements of holistic medicine. For instance, naturopathy teaches that the correct treatment of many diseases will result in a healing crisis ( 56, 57, 58, 59 ), sometimes referred to as a herxheimer reaction ( 59 ), at which point the symptoms of the disorder will actually become worse before eventual recovery occurs ( 56, 57, 58, 59 ). To a naturopath therefore, the onset of a healing crisis indicates correct treatment and the beginning of recovery ( see also, The Holistic Philosophy ). In effect therefore, symptoms may be an expression of the body's attempt to deal with the illness and restore normality. However, from the perspective of orthodox medicine, if this type of symptom deterioration occurs during a clinical trial then the treatment would be deemed to be a total failure and certainly would not compare with the effectiveness of symptom suppressing drugs. On the other hand however, from the point of view of naturopathy or holistic medicine, any trialled treatment which causes the onset of a healing crisis ( ie. an exacerbation of symptoms ) would be regarded as a successful form of therapy.

The evaluation of clinical trials clearly depends upon an assumption that any reduction of symptoms is a positive sign irrespective of the mechanism involved. Clinical trials therefore, must be interpreted from a reductionist point of view where there is no acknowledgement of restorative processes of the body and symptoms are always viewed as bad

Although clinical trials may be useful in a limited peripheral sense, bearing in mind the limitations described above, excessive reliance upon such trials represents a rejection of the traditional teachings of naturopathy and holistic medicine.

5. Overcoming Medical Bias

While it is disturbing to acknowledge the fact that most patients probably know more about alternative therapies than do their doctors ( 3 ), what is most disturbing about medical bias is the level of professional indifference it implies about the consequences of unduly influencing the result or publication of medical research. Concerns about the preservation of human life and the protection of public health should provide all the incentives necessary to ensure that medical bias does not exist. While one's conscience is generally the most effective safeguard in such matters, it is difficult indeed to totally prevent deliberate bias when there is little or no concern about either the morality, or potential consequences of bias. This is clearly a matter which needs to be addressed at the most fundamental levels of human nature.

Having said this however, it is abundantly clear that financial conflicts of interest in the medical profession should be totally eliminated. Patients certainly should not have to compete with profits. Disclosure statements are clearly insufficient and do nothing to prevent bias and ensure the accuracy of medical research ( 35 ). After all, how can disclosure statements be taken seriously when published studies may be covertly prepared by drug industry representatives? Those who fund medical research should be prevented from either choosing which trials to fund or influencing the outcome or publication of trials. Funds for medical research should perhaps be pooled so that appropriate amounts can be allocated on scientific grounds by an independent body. Any possibility that funds may be allocated according to potential profit should be completely eliminated.

Although medical bias against alternative therapies may be partly the result of the priority doctors give to conformity with their colleagues as compared to the importance with which they regard their patients ( 2 ), this is not a complete explanation. There are pronounced attitudinal and philosophical differences between medical practitioners who readily embrace alternative therapies and those who do not ( 3, 23, 60 ). Quite simply, those with a reductionist world view cannot accept or comprehend a holistic patient oriented approach.

This huge "chasm" between orthodox medicine and alternative medicine has recently been highlighted by a White House commission report into alternative therapies ( 60, 61 ).

These differences have also been highlighted by a debate between two doctors, Andrew Weil, a well known supporter of alternative therapies, and Arnold Relman, former editor of the New England Journal of Medicine ( 3, 23 ). According to Sierpina ( 3 ), Dr Relman "lives in the world of logic, proof, and rigorous scientific method" which is based upon a "view of the world existing outside himself." Dr Weil on the other hand, "is willing to grant validity to personal experience and the reality of the world within as not only a form of evidence but as a view of reality" ( 3 ). This discussion, in that it draws attention to the different mind set of those who support alternative therapies, makes a most useful contribution to the understanding of this whole debate. Certainly, the denial of the importance of personal experiences by those who oppose alternative therapies is a major point of difference and a major problem.

Denial of the importance of personal experiences, part of a reductionist rather than a holistic approach, is consistent with a fundamental disrespect for the patient. Personal experience of course, is one of the main methods by which we all learn, including doctors. Unless doctors also dismiss the results of their own experiences ( including those with their patients), there is clearly a fundamental inconsistency here which would suggest that this matter has more to do with intellectual elitism rather than some kind of science versus personal experience debate. Personal experience, being the forerunner of scientific experimentation, must be acknowledged as a vital part of the learning process. Patients should be respected, not dismissed.

Quite clearly, the medical bias against nutrition and alternative therapies is very deep rooted throughout the medical community and this is unlikely to change significantly unless there are dramatic attitudinal and philosophical changes, especially at a curricular level. Irrespective of the type of medical bias, the traditional reluctance of the medical profession to expose bias or situations which are conducive to bias, and the importance therefore of outside whistleblowers in this regard ( 39 ), it is clear that those outside the profession, such as journalists ( 39 ), will continue to play a vital corrective role. Self regulation, although undoubtedly preferred by doctors, is not in the best interests of public health. After all, the medical bias against nutrition has been continuing for hundreds of years with very little critical comment from within the profession itself, a fact which clearly underlines the importance of external whistleblowers. External whistleblowers however, need to be encouraged and perhaps legitimised in accord with the vital role they play in protecting public health.

The complete elimination of medical bias is absolutely essential if there is to be any validity at all in the claim that orthodox medicine is "scientific" and "evidence based" ( see also discussion about "evidence based medicine" ). The fear of nature and natural therapies that has been created by modern science ( 70 ) is indeed regrettable and needs to be reversed as quickly as possible.

 


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