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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:
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. 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.
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." 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.
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". 3. Conflicts of Interest and Causes of Medical BiasBias 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 ).
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 TrialsClinical 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.
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.
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.
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. This huge "chasm" between orthodox
medicine and alternative medicine has recently been highlighted by a White
House commission report into alternative therapies ( 60,
61 ). 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. 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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